HK1201434B

HK1201434B - Intrauterine systems, iud insertion devices, and related methods and kits therefor

Info

Publication number: HK1201434B
Application number: HK15101913.5A
Authority: HK
Inventors: Rob Deckman; Richard E. Repp; Curt GUYER; Justin WESTENDORF; Timothy Parmer
Original assignee: Medicines360
Priority date: 2011-07-11
Filing date: 2012-07-09
Publication date: 2017-09-01

Description

Intrauterine system, IUD insertion device and related methods and kits

Cross-referencing

This application claims priority from us public application 13/539,843 filed on day 7, 2, 2012 and from us provisional application 61/506,434 filed on day 11, 7, 2011, which application is incorporated herein by reference.

Technical Field

The present disclosure relates to intrauterine systems, intrauterine devices (IUDs), insertion devices, methods of use and kits thereof.

Background

Intrauterine devices (IUDs) are objects that, when placed in the uterus of a female, act as birth control devices to prevent conception. Both types of IUDs are commonly used, copper-containing devices and progestagen-containing devices. Hormone-containing devices are considered to be different forms of fertility control and may be distinguished in the literature as the term intrauterine system (IUS).

The effect of copper IUDs is to adversely affect sperm motility and prevent sperm binding to the egg. In addition, foreign copper bodies located within the uterus can also irritate the lining of the uterus and the uterine wall, making it difficult for an embryo to implant into the wall if the ovum is fertilized by sperm. IUS devices such as the hormone IUD Mirena (sold by Bayer) will reduce or prevent menstruation. The Mirena devices released levonorgestrel (progestin).

For IUD devices, a variety of shapes and sizes have been previously disclosed. See, for example, U.S. patent 3,407,806 entitled Contraceptive Intra-urinary Devices to Hulka et al, entitled intrauterine device for contraception, granted 10/29/1968; US patent 3,902,483 entitled Intrauterine Device with locator Means for Indicating the Uterine Position of the Device to Place et al, granted 9/2/1975; us patent 4,372,302 entitled instruments for Retrieval of retrieved Threads of intrauterine contraceptive Devices to Akerlund, 8, 1983; U.S. patent 3,973,217 entitled Intrauterine Device to Kosenen on 10.2.1976; U.S. patent 4,353,363 entitled Intrauterine Spermacide to Sopena Quesada, granted 10/12/1982; U.S. patent 4,359,046 entitled IUD Arrangement to Shaw jr, granted on 16.11.1982; U.S. patent 4,381,001 entitled IUD Arrangement to Shaw jr, granted on 26.4.1983; U.S. patent 4,495,934 entitled IUD arragemen (IUD arrangement) to Shaw jr, granted on 29/1/1985; U.S. patent 4,830,025 entitled Intrauterine Device (Intrauterine Contraceptive Device) to gainutdova et al, 5/16/1989; united states patent 4,957,119 entitled contraceptive implant to de Nijs granted on 18.9.1990; U.S. patent 5,088,505 entitled Contraceptive Implant to de Nijs granted on month 2 and 18 1992; U.S. patent 6,039,968 entitled Intravaginal Drug Delivery Device to Nabihi, 3.3.21.2000; U.S. patent 7,862,552 entitled Medical Devices for Treating urologic and Uterine Conditions to McIntyre et al, entitled Medical Devices for Treating urological and Uterine Conditions, issued on 4.1.2011; and U.S. patent publication 2005/0045183A 1 to Callister et al, entitled Methods and Devices (Methods and apparatus), 3.3.2005.

The IUD is typically inserted using an insertion device or instrument. See, for example, U.S. patent 3,783,861 entitled Inserter for Intrauterine Devices to Abramson, issued on 8.1.1974; united states patent 3,794,025 to Lerner entitled Intrauterine Device (Saddle Inserter), entitled Intrauterine Device Inserter, 2/26/1974; U.S. patent 4,920,727 to Ristimaki et al, entitled case System and Apparatus for Manufacturing an Active ingredient Capsule for Subcutnaeous Use (Cassette systems and devices for Manufacturing subcutaneous capsules for releasing Active agents), issued 5/1/1990; U.S. patent 4,949,732 entitled apparatus for Insertion and fire of an Intra urinary continuous Device to the intrauterine Device, granted on 21.8.1990; U.S. Pat. No. 5,084,004 to Ranoux, entitled Process for Intra-UlterineFertilization in Mammals and Device for Implementation theory, granted on 28.1.1992 (procedures for intrauterine fertilization in Mammals and devices for implanting the same); us patent 5,370,129 entitled IUD insertion Apparatus to Diaz et al, granted 12, 6, 1994; U.S. patent 5,400,804 to Helle et al, entitled Method and apparatus for Installing a medical capsule on a Support, entitled Helle et al, 3.28.1995; U.S. patent 5,785,053 entitled Inserter for the Positioning of an intrauterine Device to Macandrew et al, 28/7/1998.

Other relevant references in the IUS and IUD fields include, for example, U.S. Pat. Nos. 6,056,76 to Markkula et al, entitled Elastomer, Its Preparation and Use, issued 5.5.2.2000; U.S. patent 6,063,395 to Nahabi, entitled Drug Delivery Device for the Delivery of Progestins and Estrogens (Especially Delivery devices for Delivery of Progestins and Estrogens), issued 5, 16/5/2000; U.S. patent 6,103,256 entitled Intravaginal drug delivery Device to Nahabi, 8/15/2000; united states patent 6,117,442 to Markkula, entitled Drug Delivery Device, for the Delivery of androgens (Especially Delivery devices for Delivery of androgens), granted on 12.9.2000; and us patent publication 2008/0095825a1 entitled Method for creating a Reservoir Containing an active substance that diffuses through the Reservoir and apparatus Therefor, published by lafent 24, 4/2008, entitled Method for creating a Reservoir Containing a Reservoir and administering the Reservoir and apparatus Therefor.

Conventional insertion devices for IUDs, including devices for IUS, can cause pain during the insertion procedure by inducing vagal reflex responses, and even cause the patient to lose consciousness. The conventional insertion device lacks smooth operability and exhibits a problem of convenience in use. Thus, there is a need for an insertion device and related methods and kits that are adaptable and configurable for use in an IUD that reduces patient pain and trauma during the insertion procedure and provides a simple, high quality, easy to use, smooth in operation, and economical solution.

Disclosure of Invention

One aspect of the present disclosure relates to an insertion device, comprising: an elongate sheath having proximal and distal ends, and a lumen extending between the proximal and distal ends; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally-positioned user interface, wherein the proximally-positioned user interface further comprises one or more elongated guides formed at least partially in the proximally-positioned user interface and along at least a portion of a length of the proximally-positioned user interface; and a movable sheath slider in communication with the elongate sheath, wherein the movable sheath slider is adaptable and configurable to reliably move within the elongate guide, and further wherein the movable sheath slider controls axial movement of the elongate sheath. The elongated guide may be further configured to include one or more motion control features along the length of the elongated guide. Additionally, the one or more motion control structures are selected from the group consisting of hard motion control structures, soft motion control structures. Further, the one or more motion control features include at least one force limiting feature that may be configured to limit an amount of force applied to the moveable sheath slider. The one or more motion control features may be selected from the group consisting of detents, notches, grooves, protrusions, bumps, ridges, flanges, flaps, gates, flexible members, elongated guide profiles, and elongated guide curved surfaces. Additionally, the elongated guide has a length, a width, and a depth, and further wherein the width of the elongated guide is at least one of: a variable that varies along the length; and a segment width selected from two or more of the first width and the second width. The elongated guide may further be configured to have an in-plane profile selected from the group consisting of rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semi-circular, and oval. The sheath slider may also be configured to include one or more surface profiles adapted and configured to mechanically complement the one or more motion control structures. The one or more surface profiles of the sheath slider are selected from the group consisting of one or more of a respective non-flat surface, a curved surface, and an angled surface. Additionally, the housing and sheath slider further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the housing are adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. In at least some configurations, the first sheath slider alignment surface is aligned with the first housing alignment surface at a first location along the length of the elongate guide. Additionally, the one or more sheath slider alignment surfaces and the one or more housing alignment surfaces are selected from the group consisting of curved surfaces, angled surfaces, and dimensional (translational) surfaces. The elongate guide can further be configured to include one or more cavities on one or more of the proximal end of the elongate guide and the distal end of the elongate guide, wherein the one or more cavities are adapted and configured to receive at least a portion of the moveable sheath slider. In at least some constructions, the device further includes a string control slider. The string control slider may be adapted and configured to reliably move within the elongated guide. In addition, the elongate sheath slider and string control slider are adapted and configured to operate simultaneously and/or independently within one or more elongate guides. In at least some configurations, the sheath slider and string control slider are telescopically movable along at least a first portion of the elongate guide, and further wherein the sheath slider and string control slider are configurable such that at least one of the sheath slider and string slider partially surrounds the remaining slider. The sheath slider and string control slider may be further configured to include one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group consisting of a first sheath slider vertical surface, a second sheath slider vertical surface, a first string control slider vertical surface, and a second string control vertical surface, wherein one or more of the vertical surfaces are configured to form aligned adjacent surfaces at one or more locations along the length of the elongated guide. Typically, the device can be configured such that the sheath slider and string control slider have a combined width less than or equal to at least one of: 0.75 inches (19 mm), 0.7 inches (17.8 mm), 0.5 inches (12.7 mm), 0.35 inches (8.9 mm), or 0.25 inches (6.3 mm). The insertion device may also be configured to receive the IUD within the distal end of the lumen of the elongate sheath, the insertion device further including at least one wire locking structure that may be adapted and may be configured to secure one or more wire members of the IUD. In some configurations, the at least one wire locking structure comprises one or more of a cleft, clip, wedge, pincer, spring, or tooth. In other constructions, the wire locking structure includes a split and the wire unlocking structure includes a moveable member that pushes the one or more wires out of the split to unlock the one or more wires. The distal end of the elongated sheath may also be configured to have an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip. The elongate sheath distal end has an outer diameter of about 3 mm to 5 mm. In some configurations, the distal end of the elongate sheath has an outer diameter equal to or less than 80%, 50%, 30% of the outer diameter of the proximal end of the elongate sheath. Additionally, the distal end of the elongate sheath may be configured such that it has an outer diameter that is less than the maximum cross-sectional dimension of an IUD that may be positioned within the lumen of the elongate sheath. In at least some configurations, the distal end of the elongate sheath further comprises one or more slits or flaps at the forward end of the sheath. Additionally, one or more feedback mechanisms may be provided, selected from the group consisting of an audible feedback mechanism, a visual feedback mechanism, and a tactile feedback mechanism.

Another aspect of the present disclosure relates to an insertion device, comprising: an elongate sheath having proximal and distal ends, and a lumen extending between the proximal and distal ends; an elongate inner member having a proximal end and a distal end disposable within at least a portion of the lumen of the elongate sheath; a proximally positioned user interface; and an actuatable sheath control button associated with the proximally-positioned user interface in communication with the elongate sheath, wherein the actuatable sheath control button is adapted and configurable to control axial movement of the elongate sheath, wherein the elongate sheath extends distally from the housing, and wherein the sheath control button retracts the sheath proximally when the sheath control button is actuated. The elongated guide may be further configured to include one or more motion control features along the length of the elongated guide. Additionally, the one or more motion control structures are selected from the group consisting of hard motion control structures, soft motion control structures. Further, the one or more motion control features include at least one force limiting feature that may be configured to limit an amount of force applied to the moveable sheath slider. The one or more motion control features may be selected from the group consisting of detents, notches, grooves, protrusions, bumps, ridges, flanges, flaps, gates, flexible members, elongated guide profiles, and elongated guide curved surfaces. Additionally, the elongated guide has a length, a width, and a depth, and further wherein the width of the elongated guide is at least one of: a variable that varies along the length, and a segment width selected from two or more of the first width and the second width. The elongated guide may further be configured to have an in-plane profile selected from the group consisting of rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semi-circular, and oval. The sheath slider may also be configured to include one or more surface profiles adapted and configured to mechanically complement the one or more motion control structures. The one or more surface profiles of the sheath slider are selected from the group consisting of one or more of a respective non-flat surface, a curved surface, and an angled surface. Additionally, the housing and sheath slider further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the housing are adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. In at least some configurations, the first sheath slider alignment surface is aligned with the first housing alignment surface at a first location along the length of the elongate guide. Additionally, the one or more sheath slider alignment surfaces and the one or more housing alignment surfaces are selected from the group consisting of curved surfaces, angled surfaces, and dimensional surfaces. In at least some configurations, the sheath slider and string control slider are telescopically movable along at least a first portion of the elongate guide, and further wherein the sheath slider and string control slider are configurable such that at least one of the sheath slider and string slider partially surrounds the remaining slider. The sheath slider and string control slider may be further configured to include one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group consisting of a first sheath slider vertical surface, a second sheath slider vertical surface, a first string control slider vertical surface, and a second string control vertical surface, wherein the one or more vertical surfaces are configured to form aligned adjacent surfaces at one or more locations along the length of the elongate guide. Typically, the device can be configured such that the sheath slider and string control slider have a combined width less than or equal to at least one of: 0.75 inches (19 mm), 0.7 inches (17.8 mm), 0.5 inches (12.7 mm), 0.35 inches (8.9 mm), or 0.25 inches (6.3 mm). The insertion device may also be configured to receive the IUD within the distal end of the lumen of the elongate sheath, the insertion device further including at least one wire locking structure that may be adapted and may be configured to secure one or more wire members of the IUD. In some configurations, the at least one wire locking structure comprises one or more of a cleft, clip, wedge, pincer, spring, or tooth. In other constructions, the wire locking structure includes a split and the wire unlocking structure includes a moveable member that pushes the one or more wires out of the split to unlock the one or more wires. The distal end of the elongated sheath may also be configured such that it has an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip. The distal end of the elongate sheath has an outer diameter of about 3 mm to 5 mm. In some configurations, the distal end of the elongate sheath has an outer diameter equal to or less than 80%, 50%, 30% of the outer diameter of the proximal end of the elongate sheath. Additionally, the distal end of the elongate sheath may be configured such that it has an outer diameter that is less than the maximum cross-sectional dimension of an IUD that may be positioned within the lumen of the elongate sheath. In at least some configurations, the distal end of the elongate sheath further comprises one or more slits or flaps at the forward end of the sheath. In some configurations, the sheath control button and the string control button can be disposed adjacent to each other on the housing.

Yet another aspect of the present disclosure relates to an insertion device comprising: an elongate sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end, wherein the distal end of the elongate sheath forms an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; and a proximally positioned user interface. The elongated guide may be further configured to include one or more motion control features along the length of the elongated guide. Additionally, the one or more motion control structures are selected from the group consisting of hard motion control structures, soft motion control structures. Further, the one or more motion control features include at least one force limiting feature configurable to limit an amount of force applied to the moveable sheath slider. The one or more motion control features may be selected from the group consisting of detents, notches, grooves, protrusions, bumps, ridges, flanges, flaps, gates, flexible members, elongated guide profiles, and elongated guide curved surfaces. Additionally, the elongated guide has a length, a width, and a depth, and further wherein the width of the elongated guide is at least one of: a variable that varies along the length, and a segment width selected from two or more of the first width and the second width. The elongated guide may be configured to have an in-plane profile selected from the group consisting of rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semi-circular, and oval. The sheath slider may also be configured to include one or more surface profiles adapted and configured to mechanically complement the one or more motion control structures. The one or more surface profile sheath sliders are selected from the group comprising one or more of a respective non-flat surface, curved surface and angled surface. Additionally, the housing and sheath slider further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the housing are adapted and configured to mechanically complement the one or more alignment surfaces of the sheath. In at least some configurations, the first sheath slider alignment surface is aligned with the first housing alignment surface at a first location along the length of the elongate guide. Additionally, the one or more sheath slider alignment surfaces and the one or more housing alignment surfaces are selected from the group consisting of curved surfaces, angled surfaces, and dimensional surfaces. The elongate guide can be configured to include one or more cavities on one or more of a proximal end of the elongate guide and a distal end of the elongate guide, wherein the one or more cavities are adapted and configured to receive at least a portion of the moveable sheath slider. In at least some constructions, the device further includes a string control slider. The string control slider may be adapted and configured to reliably move within the elongated guide. In addition, the elongate sheath slider and string control slider are adapted and configured to operate simultaneously and/or independently within one or more elongate guides. In at least some configurations, the sheath slider and string control slider are telescopically movable along at least a first portion of the elongate guide, and further wherein the sheath slider and string control slider are configurable such that at least one of the sheath slider and string slider partially surrounds the remaining slider. The sheath slider and string control slider may be further configured to include one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group consisting of a first sheath slider vertical surface, a second sheath slider vertical surface, a first string control slider vertical surface, and a second string control vertical surface, wherein one or more of the vertical surfaces are configured to form aligned adjacent surfaces at one or more locations along the length of the elongated guide. Typically, the device can be configured such that the sheath slider and string control slider have a combined width less than or equal to at least one of: 0.75 inches (19 mm), 0.7 inches (17.8 mm), 0.5 inches (12.7 mm), 0.35 inches (8.9 mm), or 0.25 inches (6.3 mm). The insertion device may also be configured such that the IUD is to be received within the distal end of the lumen of the elongate sheath, the insertion device further comprising at least one wire locking structure that may be adapted and may be configured to secure one or more wire members of the IUD. In some configurations, the at least one wire locking structure comprises one or more of a cleft, clip, wedge, pincer, spring, or tooth. In other constructions, the wire locking structure includes a split and the wire unlocking structure includes a moveable member that pushes the one or more wires out of the split to unlock the one or more wires. The distal end of the elongate sheath has an outer diameter of about 3 mm to 5 mm. In some configurations, the distal end of the elongate sheath has an outer diameter equal to or less than 80%, 50%, 30% of the outer diameter of the proximal end of the elongate sheath. Additionally, the distal end of the elongate sheath may be configured such that it has an outer diameter that is less than the maximum cross-sectional dimension of an IUD that may be positioned within the lumen of the elongate sheath. In at least some configurations, the distal end of the elongate sheath further comprises one or more slits or flaps at the forward end of the sheath. Additionally, one or more feedback mechanisms may be provided, selected from the group consisting of an audible feedback mechanism, a visual feedback mechanism, and a tactile feedback mechanism. In at least some configurations, the device further includes one or more motion control structures along the length of the elongated guide.

Additional aspects of the present disclosure relate to a kit comprising: an insertion device having an elongate sheath having proximal and distal ends and a lumen extending therebetween; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally-positioned user interface, wherein the proximally-positioned user interface further comprises one or more elongated guides formed at least partially in the proximally-positioned user interface and along at least a portion of a length of the proximally-positioned user interface; and a movable sheath slider in communication with the elongate sheath, wherein the movable sheath slider is adaptable and configurable to reliably move within the elongate guide, and wherein the movable sheath slider controls axial movement of the elongate sheath; and an intrauterine device positionable within the distal lumen of the elongate sheath.

Still other aspects of the present disclosure relate to a kit comprising: an insertion device having an elongate sheath having proximal and distal ends and a lumen extending therebetween; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally positioned user interface; and an actuatable sheath control button associated with the proximally-positioned user interface in communication with the elongate sheath, wherein the actuatable sheath slider is adapted and configurable to control axial movement of the elongate sheath, wherein the elongate sheath extends outwardly from the housing, and wherein the sheath control button retracts the sheath proximally when the sheath control button is actuated; and an intrauterine device positionable within the distal lumen of the elongate sheath.

Yet another aspect of the present disclosure relates to a kit comprising: an insertion device having an elongated sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end, wherein the distal end of the elongated sheath forms an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; and a proximally located user interface; and an intrauterine device positionable within the distal lumen of the elongate sheath.

Still other aspects of the disclosure relate to a method of using an insertion device: the method comprises the following steps: advancing an insertion device, the insertion device having an elongate sheath with proximal and distal ends, and a lumen extending between the proximal and distal ends; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally-positioned user interface, wherein the proximally-positioned user interface further comprises one or more elongated guides formed at least partially in the proximally-positioned user interface and along at least a portion of a length of the proximally-positioned user interface; and a movable sheath slider in communication with the elongate sheath, wherein the movable sheath slider is adaptable and configurable to reliably move within the elongate guide, and further wherein the movable sheath slider controls axial movement of the elongate sheath; actuating a sheath slider; performing at least one of: moving the elongate sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and releasing the IUD from the insertion device.

Additional aspects of the disclosure relate to a method of using an insertion device, comprising: advancing an insertion device, the insertion device having an elongate sheath with proximal and distal ends, and a lumen extending between the proximal and distal ends; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally positioned user interface; and an actuatable sheath control button associated with the proximally-positioned user interface in communication with the elongate sheath, wherein the actuatable sheath slider is adapted and configurable to control axial movement of the elongate sheath, wherein the elongate sheath extends outwardly from the housing, and wherein the sheath control button retracts the sheath proximally when the sheath control button is actuated; actuating a sheath control button; performing at least one of: moving the elongate sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and releasing the IUD from the insertion device.

The present disclosure also contemplates a method of using an insertion device, comprising: advancing an insertion device, the insertion device having an elongate sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end, wherein the distal end elongate sheath forms an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; and a proximally located user interface; performing at least one of: moving the elongate sheath proximally and advancing the IUD distally; automatically or semi-automatically increasing the radial diameter of the IUD; and releasing the IUD from the insertion device.

All publications, patents and patent applications mentioned in this specification are herein incorporated by reference as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present invention and, together with the description, serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention.

FIGS. 1A-1C illustrate a conventional IUD insertion device;

fig. 2 illustrates a conventional T-shaped IUD;

figures 3A-3E illustrate the positioning of an IUD during a first stage of IUD insertion;

fig. 4A-4C show a visual representation of the positioning of the IUD within the insertion device during the transition from the first stage (1) to the second stage (2) of IUD insertion, and fig. 4D-4F show the positioning of the IUD within the insertion device during the second stage of IUD insertion;

figures 5A-5C illustrate the positioning of the IUD during a third stage of insertion;

FIG. 6A shows a top view of the insertion device, and FIGS. 6B-6D show details of the insertion device handle, slider, and slot configuration;

FIGS. 7A-7C illustrate various notch configurations and configurations suitable for incorporation into an insertion device handle;

fig. 8A shows a top view and fig. 8B shows a side view of the insertion device; FIG. 8C illustrates an exploded view of the device of FIGS. 8A-8B showing the individual components and a method of assembling the device; FIGS. 8D-8F show side views of the device with the slider in different positions;

FIGS. 9A and 9B illustrate a position control structure of the insertion device;

FIG. 10A shows a perspective view of an insertion device; fig. 10B illustrates a top view of the insertion device shown in fig. 10A, and fig. 10C illustrates a side view of the insertion device shown in fig. 10A. FIGS. 10D-10F illustrate the operational positioning of the insertion device during the first, second and third stages of an IUD insertion procedure;

FIG. 11 shows an insertion device having multiple sliders;

FIG. 12A shows a top view of the insertion device, and FIG. 12B shows a side view of the insertion device;

fig. 13A shows a top view and fig. 13B shows a side view of the insertion device with the telescopic slider;

fig. 14A shows a top view and fig. 14B shows a side view of an insertion device with a telescopic slider;

fig. 15A-15C illustrate the operational positioning of an insertion device including a telescoping slider during first, second and third stages of an IUD insertion procedure;

16A-16C illustrate an insertion device having a position control structure that includes a crank system;

17A-17C illustrate an insertion device having a position control structure that includes a crank system;

18A-18B illustrate an insertion device having a position control mechanism including a gear system;

19A-19B illustrate an insertion device having a position control structure including a gear and pawl system;

FIG. 20A shows a top view and FIGS. 20B-20D show cross-sectional side views of an actuatable telescoping control button for controlling a member of an insertion device;

FIG. 21A shows a top view and FIGS. 21B-21D show cross-sectional side views of an actuatable side-by-side control button for controlling a component of an insertion device;

FIGS. 22A-22C show cross-sectional side views illustrating the actuation mechanism of the actuatable sheath position control button;

FIGS. 23A-23E illustrate various IUD position control features of the insertion device plunger and sheath;

24A-24G illustrate aspects of the elongated sheath and atraumatic sheath tip of the insertion device;

FIGS. 25A-25B illustrate various wire locking structures;

FIGS. 26A-26E illustrate various wire control structures including wire locking and wire unlocking structures;

27A-27C illustrate various wire control configurations including wire locking and wire unlocking configurations;

FIG. 28 illustrates an exemplary aspect of an insertion device including a wire control structure;

29A-29D illustrate various wire control structures including wire locking and wire unlocking structures, as well as sheath alignment structures;

FIGS. 30A-30B illustrate an indexing arrangement for an insertion device;

FIGS. 31A-31B illustrate features of an insertion device sheath, including IUD loading structures and methods; and

fig. 32A-32B illustrate an IUD loading structure and method.

Detailed Description

I. Plug-in program

Conventional intrauterine insertion devices include inserters or insertion devices, such as the device shown in figures 1A-1C, which comprise: a sheath 132 having proximal and distal ends and a lumen extending therebetween for receiving an IUD; a plunger 134 for pushing the IUD through the sheath; and a user interface, such as a handle 135, for holding the insertion device. The device shown in fig. 1A-1C requires a two-handed procedure, wherein the operator holds the handle 135 in one hand and the sheath 132 in the other hand.

As will be discussed in more detail below, in contrast to conventional insertion devices such as that depicted in fig. 1, the insertion devices of the present disclosure are configured to receive an IUD during an insertion procedure, and are further configured to assist in positioning the IUD during the insertion procedure, as well as advancing the IUD from the insertion device into the uterus of a patient. The insertion device may be adapted and configured to insert a variety of IUD configurations.

For example, a T-shaped IUD 202, such as the IUD shown in fig. 2, may be used with the insertion device. When an IUD is in a fully deployed position, the IUD typically has a length of about 31.90 mm to about 32.22 mm and a width of about 31.81 mm to about 32.13 mm. As will be understood by those skilled in the art, the length does not include knots or threads that may accompany an IUD. The T-shaped IUD includes an elongated body 204, the elongated body 204 having a proximal end 10 and a distal end 20. The elongate body 204 may include a coating, such as a time-release drug or hormone. The elongated body may be formed of any suitable material, including but not limited to plastic or copper. At the distal end 20 of the IUD (i.e., the end positioned away from the hand of the physician), the arms 206a, 206b are attached to the elongated body 204 or are integrally formed with the elongated body 204. The arms 206a, 206b may be configured to fold up u or down d to minimize the IUD cross-section so that the IUD may fit into an insertion device sheath or tube to pass through the cervix and into the uterus. Additionally, either or both of the arms 206a, 206b may be configured to include an enlarged or spherical tip 208a, 208b, for example, having a curved, spherical, or hemispherical shape. The ends 208a, 208B of the arms 206a, 206B may be formed such that when the arms are folded upward and pushed together, the arms form a smooth and rounded distal end, for example as shown in fig. 3B-3C and described below. At the proximal end of the IUD10, the IUD may further include one or more wires 210a, 210b attached to the IUD. The thread may be attached to the IUD at attachment point 211, for example knotted as shown.

Although the insertion devices are generally described herein with respect to T-shaped IUDs (such as the IUD shown in fig. 2), it should be noted that the insertion devices of the present disclosure may be adapted to facilitate insertion into other IUD configurations, as will be understood by those skilled in the art. Furthermore, the insertion device operation and IUD insertion procedure may include any number of steps corresponding to the desired IUD location. In addition to the structures described below, the insertion devices of the present disclosure include IUD position control structures that may facilitate insertion of IUDs having a variety of configurations. For example, although the IUD insertion procedure described below refers to a three-stage procedure corresponding to three different IUD positions, the insertion device operating procedure may include fewer than three or more than three steps. Thus, the insertion device may include any number of position control structures corresponding to the desired IUD position. The insertion devices of the present disclosure may be used in a variety of conventional IUDs commercially available, including devices such as T-frame LNg-20 IUD marketed as Bayer Mirena LNg, and Neo-Safe CUT 380A available from Mona-Lisa.

The insertion devices disclosed herein may be configured to operate according to procedural steps generally similar to IUD insertion procedures commonly known and used. However, the insertion device of the present disclosure includes improvements to the device structure and operation. In another aspect of the disclosed apparatus, the program steps for IUD insertion comprise: (i) a pre-insertion device preparation procedure, (ii) a first stage of IUD insertion (also referred to herein as stage 1, position 1 or step 1), (iii) a second stage of IUD insertion (also referred to herein as stage 2, position 2 or step 2), (iv) a third stage of IUD insertion (also referred to herein as stage 3, position 3 or step 3), and (v) a post-insertion procedure.

The pre-insertion device preparation procedure may include loading an IUD (such as the IUD shown in fig. 2) into the insertion device, aligning the IUD with the patient in-plane, positioning the IUD in the correct longitudinal position along the length of the sheath of the insertion device, and locking the IUD into position for insertion. Such a pre-insertion device preparation procedure is described in more detail below.

Fig. 3A-3D illustrate positioning of an insertion device 300 during a first stage of IUD insertion according to an aspect of the present disclosure. The insertion device 300 is sized and configured for positioning within the uterus, the insertion device 300 having a tube length (or working length) of 15 cm to 25cm, and a diameter of 3 mm to about 5 mm. The sheath 332 has proximal and distal ends, and a lumen extending therebetween, the distal end 20 being advanced through a cervical canal (not shown) such that the sheath 332 protrudes slightly into the uterus, as shown in fig. 3A using a display representing human anatomy. The IUD 302 has not yet been deployed and is still within the sheath 332. The IUD hands 308a, 308B may be partially deployed to create a rounded shape at the distal tip 20 of the insertion device 300, as shown in fig. 3B, while the elongated body 304 of the IUD remains within the sheath 332. Alternatively in aspects where the insertion device sheath 332 or other structure provides a rounded distal tip, the IUD arms 306a, 306B may be wrapped by the sheath 332, as shown in cross-section taken along line B-B in fig. 3B, and as shown in fig. 3C. The distal end 20 of the sheath 332 may be configured such that its rounded tip may flare out like a horn when an IUD positioned within the sheath is advanced beyond its distal end (e.g., an orifice having a first diameter when the IUD is fully positioned within the sheath, and an orifice having a second, larger diameter when the IUD is advanced distally beyond the tip of the sheath).

Figure 3D shows another cross-section of the insertion device 300 taken along line D-D in figure 3B. As can be seen in this figure, when IUD 302 is fully positioned within sheath 332, distal tip 20 has an aperture 331, the diameter d1 of aperture 331 being smaller than the diameter d2 of IUD 302. Fig. 3E illustrates a top view of the tube of the device taken from view E-E in fig. 3B of the insertion device 300 during a first stage of IUD insertion according to an aspect of the present disclosure. The aperture 331 has a diameter d1, the diameter d1 being smaller than the diameter d2 of the sheath 332. The IUD 302 can be rotated r in-plane about the longitudinal axis x, as shown in fig. 3D, such that the IUD arms or similar structures of the IUD will deploy in-line with the corresponding openings of the patient's fallopian tubes.

Fig. 4A-4C depict cross-sections of the IUD 402 and insertion device 400 along cross-section D-D of fig. 3B during a transition from a first stage (1) to a second stage (2) of IUD insertion. As shown in fig. 4c, the arms 406a, 406b of the IUD 402 have been advanced distally (i.e., towards the distal end 20) and away from the sheath 432, the sheath 432 having a proximal end and a distal end, and a lumen extending therebetween, the sheath 432 allowing the arms 406a, 406b to extend radially away from the central axis x. Fig. 4D-4F illustrate the positioning of the insertion device 400 during a second stage of IUD insertion. In stage 2, the IUD 402 is partially deployed from the sheath 432, as shown in fig. 4B.

Turning now to fig. 4D-4F, the IUD 402 is partially deployed such that the elongate body 404 of the IUD 402 is still positioned within the sheath 432 and the arms 406a, 406b are deployed from the sheath 432 and deployed to extend outwardly from the elongate body 404 of the IUD 402. As shown in fig. 4E, the insertion device 400 extends distally into the uterus (not shown) until the flange 433 reaches a set distance of the outer os 422 of the cervix 420 and the IUD is partially deployed from the insertion device sheath 432 into the uterus (not shown). During use, a clinician manipulating the insertion device may maintain the position shown in fig. 4E for a period of time, e.g., 10-25 seconds, and more, more than 15 seconds, to ensure that the IUD arms 406a, 406b are fully deployed or expanded into a desired position or configuration. Subsequently, as shown in fig. 4F, the insertion device 400 is advanced distally until the flange 433 reaches the outer opening of the cervix (not shown), whereby the IUD arms 406a, 406b contact the fundus 416 of the uterus (not shown).

Fig. 5A-5C illustrate the positioning of the IUD 502 during a third stage of the insertion procedure. As shown in fig. 5A-5B, the IUD 502 is fully deployed from an insertion device (not shown) into the uterus 514, and the IUD wire 510 extends from the uterus 514, through the cervix 520, and into the vagina 524, as shown in fig. 5B. Fig. 5B provides a plan view showing a detailed illustration of the relevant female anatomy, including uterus 514, fundus 516, tubal openings 518a, 518B, cervix 520, cervical canal 521, external orifice 522 of cervix 520, and internal orifice 523 of cervix 520.

After the IUD insertion phase is complete, post-insertion procedures are performed, such as removing the insertion device sheath from the patient and cutting the IUD wire to a length appropriate for the particular patient.

The insertion device of the present disclosure exhibits improved device structure and operation techniques, as well as improved ease of operation. The insertion devices of the present disclosure are configured to reduce pain and trauma experienced by a patient during an IUD insertion procedure. Most women have cervix with varying opening diameters, from about 1mm to about 3 mm. The size and shape of the cervix varies considerably with the age of the patient, the hormonal status of the patient, and whether the patient is transvaginal to pass a child. However, IUDs and insertion devices typically have a diameter greater than the diameter of the cervical canal, particularly at the external and internal os of the cervix or uterus. This mismatch between the diameters of the cervix and the insertion device can create a resistive path for IUD insertion that can prevent proper IUD insertion, as well as cause traumatic insertion to the patient. The diameter of the IUD and conventional insertion devices is large compared to a typical female human cervical canal into which the IUD and applicator are inserted during the IUD insertion procedure. As will be appreciated by those skilled in the art, traumatic IUD insertion procedures can cause a variety of undesirable side effects, including (but not limited to) bleeding, severe pain, and adverse vasovagal responses, which can lead to syncope or convulsions.

Pain during the IUD insertion procedure is reduced by the structure and operation of the insertion device, as well as by making the insertion device easy to operate. Traumatic insertion can be caused by difficulty in handling the IUD insertion tool, malfunctioning of the insertion device, improper positioning of the IUD during insertion, operator error, and inherent design structure of the insertion device itself. The insertion devices of the present disclosure are configured to reduce resistance and friction during the IUD insertion process. The insertion device may be configured to operate smoothly, quickly, stably, easily, and in a highly controlled and consistent manner, thereby reducing trauma to the patient during insertion and deployment of the IUD.

The present disclosure provides insertion device structures and operations that control the position of an IUD during various stages of an insertion procedure. Conventional insertion devices do not provide a reliable mechanism to position the IUD and maintain proper IUD positioning during the insertion procedure. Fixing the IUD in place during the various stages of insertion is important for proper and pain-free insertion. Improper IUD positioning, such as misalignment and premature or late deployment of the IUD, can result in failed and painful insertions. The present disclosure provides improved position control by using position control structures for controlling both in-plane and longitudinal alignment of an IUD during an insertion procedure. In one aspect of the disclosed device, the insertion device further includes position control feedback or signal structure to provide verification and assurance of proper IUD positioning.

IUD position & alignment control

The insertion devices of the present disclosure may be configured to exhibit a high degree of control and accuracy in positioning the IUD during the IUD insertion procedure. It is important to control the positioning and alignment of the IUD with a high degree of accuracy during the IUD insertion procedure. For example, in the IUD insertion procedure shown in fig. 3-5 and discussed above, it is important to control the longitudinal position of the IUD, the in-plane alignment of the IUD, and the cross-section of the IUD and insertion device sheath.

As discussed above, the IUD 302 may be rotated r in-plane about the longitudinal axis x as shown in fig. 3D such that a similar structure of the IUD arm or IUD will deploy into alignment with the respective openings 518a, 518B of the patient's fallopian tubes as shown in fig. 5B to achieve in-plane alignment. Generally, when the IUDs are in planar alignment, the IUDs lie flat, or substantially flat, in a plane defined by the tubal openings 518a, 518B and the cervical canal 521 (such as the coronal plane shown by x-y in fig. 5B). When the IUD is deployed, the IUD arms 506a, 506b or similar functional structure for a non-T-shaped IUD will be positioned near the openings 518a, 518b of the fallopian tubes. The proximal end of the IUD elongate body 504 is proximate the internal os 523 of the cervix, and the IUD wire 510 extends proximally from the IUD 502 into the vagina 524.

In insertion stage 1, as shown in fig. 3A-3E, the IUD 302 is positioned within the delivery device 300 such that the IUD 302 will not deploy prematurely, but will deploy easily during the transition to stage 2. The distal end 20 of the insertion device 300 may be configured in cross-section such that it presents a minimum diameter along the longitudinal portion of the insertion device inserted into the cervix and uterus of the patient, and the distal tip 301 of the insertion device 300 may be further configured to present a rounded or curved, smooth, and distal end without blunt or abrupt structures. The use of a rounded distal tip without a blunt or abrupt structure reduces or eliminates injury or trauma to the patient, as well as any obstruction that smoothly passes the insertion device through the cervical canal and into the uterus. The IUDs 302 are preferably deployed into the uterus in an in-plane alignment such that the deployed IUDs will be substantially on, for example, the coronal plane as discussed above.

Position control structure

The present disclosure describes insertion devices that include one or more structures for controlling the longitudinal position of an IUD during various stages of an IUD insertion procedure. The insertion device may be adapted and may be configured to comprise an IUD insertion device comprising an elongate inner member and an elongate sheath at least partially surrounding or enclosing the elongate inner member, wherein the inner member and the sheath may be configured to engage in a translational movement relative to each other along the longitudinal axis. Furthermore the IUD insertion device can accommodate a variety of IUD configurations.

The elongated sheath of the insertion device accommodates the IUD during the insertion procedure and has a narrow sheath tip cross-section at its distal end such that the distal end of the sheath and the IUD accommodated therein will fit through the cervix during insertion of the insertion device into the uterus. In at least some configurations, the tip of the tube tapers from its maximum diameter (e.g., 3-5mm) at a distal 1mm to 2mm to a value of about 50-90% of the diameter (e.g., a diameter of about 2.4 mm to about 4.4 mm) at the distal-most portion. The insertion device sheath tip is configured to compress an IUD positioned within the sheath along its elongated longitudinal or longitudinal axis by restraining the IUD within the narrow sheath opening. In at least some configurations, the insertion device sheath is an elongated member, such as an elongated hollow cylinder or tube, that is hollow along at least a portion of its longitudinal length. The elongated sheath of the insertion device may further be configured to be flexible enough to allow the sheath to be molded or shaped to the different anatomy of each patient, yet strong and stiff enough to resist collapsing or undesirable movement during the insertion procedure. Suitable materials for the insertion device sheath include biocompatible materials such as plastics or thermoplastic polymers including, for example, polyethylene or polypropylene.

The elongate inner member fits at least partially within the lumen or opening of the sheath and, thus, the elongate inner member is at least partially encased or encompassed by the sheath whereby the inner member can slide within the sheath along the longitudinal axis without undesirable friction. The elongated inner member may be a rod, a sheath, or any elongated member capable of translating the IUD along the longitudinal axis during the IUD insertion procedure. The elongate inner member or plunger is typically constructed such that it is sufficiently flexible to allow the plunger to assume the shape of the elongate sheath once it is molded or shaped against the anatomy of an individual patient. Suitable materials for the insertion device sheath include biocompatible thermoplastic polymers such as polyethylene or polypropylene. In one aspect of the disclosed device, at least a portion of the plunger is hollow to provide a pathway for one or more wire members of the IUD to pass through.

Translational movement of the elongated inner member and the insertion device sheath relative to each other along the longitudinal axis allows translational movement of the IUD relative to the insertion device sheath and/or the elongated inner member along the longitudinal axis. The IUD and the inner member typically do not translate relative to each other along the longitudinal axis. In addition, the insertion device sheath and typically translate along the longitudinal axis relative to each other during the IUD insertion procedure, whereby the insertion device sheath is pulled proximally (withdrawn) from the uterus and cervix while the IUD is still deployed in the uterus.

As will be understood by those skilled in the art, the insertion device may be configured such that the elongate inner member may be pushed or extended distally (toward the patient and away from the operator) to deploy the IUD, or withdrawn or extended proximally (away from the patient and toward the operator). Thus, for example, the sheath may be proximally withdrawn and/or the elongate inner member may be distally extended to deploy the IUD.

In some configurations, the plunger may be configured such that it remains stationary during the insertion procedure and only the sheath is retracted. In other aspects, the sheath can be configured to remain stationary and only the plunger is advanced distally. In still other aspects, the insertion device includes one or more of a sheath and a plunger position control structure that allow both the sheath and the plunger to move the same distance or different distances at the same or different times. For example, in step 1, the insertion device is advanced distally through the cervical canal and into the uterus. In step 2, the position control mechanism pushes the plunger slightly distally to deploy the IUD arm. Optionally, the position control structure then moves both the plunger and sheath distally so that the arms of the IUD are near the base of the uterus (i.e., the top portion opposite the cervix). In step 3, either the sheath is retracted and the plunger is advanced distally, or the sheath alone is retracted proximally.

The insertion device of the present disclosure may be further adapted and configured to include a handheld IUD insertion device further including an elongate inner member, an elongate sheath at least partially surrounding or enclosing the elongate inner member, and at least one control structure controlling translational movement of the elongate inner member and the elongate sheath relative to each other along the longitudinal axis.

Slider control

In one aspect of the insertion device of the present disclosure, as shown in fig. 6A-6C, an insertion device 600 having a proximal end 10 and a distal end 20 comprises a handheld insertion device including an elongate inner member (plunger) 634, an elongate sheath 632, an interface such as a user interface or handle 635, and a slider 642 for actuating or controlling translational movement of the elongate sheath 632 and elongate inner member 634 relative to each other along their longitudinal axes. The insertion device handle 635 provides a housing for insertion device components such as the proximal end 10 of the sheath 632, the proximal end of the plunger 634, and the slider 642. The handle 635 may further be configured such that an operator can engage the handle 635 when operating the insertion device 600. The handle 635 may be configured to include an elongated guide (slot, channel, slider rail, or slider window) 640. The elongated guide 640 may be adapted and configured to provide a guide or channel (e.g., a U-shaped channel, or a channel having a lower surface and two sidewalls) along which the slider 642 may move or slide during operation. The slider 642 may be configured such that it is physically attached to the elongate sheath 632 and directly controls the longitudinal position and translational movement of the sheath 632 in the proximal and/or distal direction relative to the elongate inner member 634 and the IUD (not shown). In operation, an operator's finger, or preferably a thumb, moves the slider 642 along the elongate guide 640.

The slider and elongated guide system may be configured to enable a user to control IUD positioning during an insertion procedure. As shown in fig. 6B, during step 1 of the insertion procedure, the slider 642 is located at the most distal starting position. In step 2, the user moves the slider 642 along the elongate guide 640 to a second position (not shown). In step 3, the user moves the slider 642 along the elongate guide 640 to a third position (not shown). Typically, for steps 2 and 3, slider 640 is positioned in a distal position and then moved proximally.

As described above, maintaining a smooth, rounded and low profile tip of the insertion device, as shown in fig. 3A-4A, reduces pain and prevents premature deployment of the IUD from the insertion device. Maintaining proper IUD position and controlling the position of the IUD, the elongated sheath of the insertion device, and the elongated inner member of the insertion device during the insertion procedure may also alleviate other problems that may arise during the insertion procedure, such as management of the IUD wire. In addition to the slider and elongated guide systems described above, the insertion devices of the present disclosure may be further configured to include one or more additional features to improve IUD position control.

In another aspect of the disclosed device, the slider, elongate guide and/or housing may be adapted and configured to include one or more position control features that ensure that the slider remains in place at various stages of the insertion procedure, such as the positions shown in fig. 3-5. For example, as shown in fig. 6C (fig. 6C depicts a handle, with the slider 642 not positioned in the elongate guide 640), the position control structures 641a, 641b, 641C assist the user in controlling the slider position to position the slider at predefined positions corresponding to various procedural steps. As shown in fig. 6c-d, the position control structures 641a, 641b, 641c are female recesses configured to mate with male protrusions (not shown) on the slider. These position control structures are detents that serve as a mechanism for temporarily holding one component (the slider and its attachment) in a certain position relative to the other component (the handle) and that can be released by applying a force to one component. By accurately controlling the position of the sheath slider of the insertion device, the sheath will be properly positioned relative to the IUD, as the sheath slider controls the sheath. The position control structure may be a "soft stop" structure that hinders or interrupts the otherwise uniform sliding movement of the slider along the elongate guide.

In some configurations, the soft motion control structures (e.g., stop structures, position control structures, and movement control structures) do not rely on direct physical contact between motion control surfaces of different components of the insertion device, such as those provided with detent structures. For example, the elongated guide soft stops 641a, 641b, 641C may be adapted and configured to reduce the width w of the elongated guide 640, or to reduce the tolerance between the elongated guide and the slider, whereby there is increased friction between the sheath 642 slider and the housing 635 at different positions along the elongated guide 640 corresponding to program stops or pauses (e.g., steps 1, 2, or 3 corresponding to the IUD position shown in fig. 3A, 4C, and 5C, respectively). This configuration may replace the detent configuration described above. The position control structure of the housing, elongated guide, and/or slider may include physical structures such as detents, notches, grooves, protrusions, bumps, ridges, flanges, flaps, gates, flexible members, contours, curves, shapes, etc., that may be configured to resist movement of the slider in the housing or elongated guide at the corresponding location. For at least some configurations, a soft motion control structure may be preferred over a hard motion control structure because the soft motion control structure may increase user control during operation.

As will be appreciated by those skilled in the art, the motion control structure may also include a "hard stop" structure that includes physical contact between the slider and surfaces of other components of the insertion device to inhibit further movement of the slider in an undesirable direction. Typically, the hard stop comprises direct physical contact between two or more device components, whereby the hard stop inhibits any component from further movement past the hard stop point. For example, the insertion device shown in fig. 6D includes a first hard motion control surface 641D (e.g., a stop surface) at the distal end of the elongate guide 640 and a second hard motion control surface 641e at the proximal end of the elongate guide 640. In this configuration, step 1 of the insertion procedure may be defined by physical contact between the slider 642 and the first hard motion control surface 641d, and step 3 of the insertion procedure may be defined by physical contact between the slider (not shown) and the second hard motion control surface 641 e. Intermediate stopping may be facilitated by using a soft stop 641b similar to the soft stop shown in fig. 6C.

When the stop position for the program phase includes hard motion control structures (e.g., stop structures, position control structures, and movement control structures), the user is more likely to use excessive speed or force when moving the slider. The hard motion control structure may prompt the user to ignore the discreet, precise, and careful requirements, as the user will rely on contact between the hard motion control surfaces to ensure that the procedural steps are completed. The user is more likely to use excessive force and the full force strikes the slider or other position control structure into contact with the hard motion control surface, which can result in destructive movement of the entire insertion device as a whole, as well as causing pain to the patient, or disrupting the insertion procedure. Unlike hard stops, the soft motion control surface of the present disclosure encourages the user to be careful, precise, and careful during the insertion procedure. In addition, certain soft stop control features of the disclosed structure may be felt by the user's thumb or fingers, thereby providing the user with sensory signals corresponding to program steps or stop points. For example, with the device shown in fig. 6D, the user does not feel that the hard motion-control surfaces 641D, 641e are in direct contact with the user's thumbs.

However, as set forth in more detail below with respect to the device shown in fig. 8A-8F, the device has a proximal end 10, a distal end 20, an upper surface 30, a lower surface 40, and at least one side surface 50. When using the device of the present disclosure, at steps 1 and 3, the user may feel that the housing surfaces 844a, 844b (which are force limiting structures) are in direct contact with the user's thumb, as shown in fig. 8D and 8F, respectively. While the force limiting structures 844a, 844b of the insertion device 800 prevent the slider 842 from moving beyond the housing surfaces 844a, 844b, the force limiting structures do not require contact between multiple insertion device members, such as between the slider 842 and the housing surfaces 844a, 844 b. Those skilled in the art will recognize the additional benefits of a soft motion control configuration. For example, the soft motion control feature may minimize sharp edges of the insertion device and prevent the insertion device from catching on the user.

The position control structure of the present disclosure, such as the slider structure, the elongated guide structure, and/or the housing structure, is a soft motion control structure that provides a soft stop during operation of the insertion device and only hinders or interrupts the sliding movement of the slider along the elongated guide, thereby promoting smooth and unobstructed sliding motion. However, the structure may also include a "hard stop" structure that inhibits further movement of the slider in an undesirable direction.

Alternatively or additionally, the housing or elongated guide may be adapted and configured to include one or more sensory signal structures or indicators that provide sensory feedback to the user that the slider is in the proper position corresponding to one or more stages of the insertion procedure. Indicating structures such as sensory signal structures are discussed in more detail below. For example, the sensory signaling structure of the insertion device may include a visual indicator (such as a visual alignment structure), an audible indicator (such as a click or other sound heard by the insertion device operator), and/or a tactile indicator structure that is perceptible to the operator, such as a tactile indicator perceptible to the operator's finger or thumb.

The slider may be a sheath slider attached to the elongated sheath to retract the sheath to deploy the IUD. Alternatively or additionally, the slider may be a plunger slider that is attached to the plunger and pushes the plunger distally to deploy the IUD. The slider may include any suitable structure that allows a user to move the slider. For example, the slider may include a button, tab, notch, or any interface suitable for moving the slider and attached sheath or plunger in the appropriate direction. Preferably, the slider slides smoothly along the elongate guide, but it is also preferred that there is some friction between the slider and the elongate guide so that the slider does not slide along the elongate guide too easily. Some friction between these members is preferred so that the user can control the slider movement, and the slider does not slide easily or accidentally along the elongated guide without the user applying a force-i.e. the slider does not move in the elongated guide due to gravity or external movement alone. As will be appreciated by those skilled in the art, the tolerance or gap between the components of the insertion device may be adjusted to provide the appropriate amount of friction between the components. Such friction or resistance exists entirely consistently or substantially between the slider and the housing or elongate guide, rather than between the sheath and the plunger.

Additional elongated guide configurations may be incorporated into any insertion device of the present disclosure. For example, the housing or handle described above may be adapted and configured to have a variety of elongated guide configurations shown in fig. 7A-7C. For example, for a curved elongated guide 740, as shown in the example depicted in the figures. In fig. 7A-7C, one or more curves C1, C2, C3 may be configured to correspond to procedural steps such as stopping or pausing, wherein the curves provide a soft stop or increased resistance to movement of the slider 742 within the elongate guide 740 or channel. The increased friction between the elongate guide 740 and the slider 742 at one or more of the curves c1, c2, c3 of the elongate guide 740 slows the slider 742 motion, creating a soft stop at one or more curved locations along the length of the elongate guide. The curves c1, c2, c3 in the elongated guide 740 are arranged along the longitudinal axis x of the insertion device handle, whereby the slider moves left and right when sliding along the elongated guide. As will be understood by those skilled in the art, in some configurations, both side-to-side and longitudinal movement may be achieved by a slider. In still other embodiments (not shown), the elongated guide curves are disposed at different depths within the handle, whereby the slider moves up and down as it slides along the elongated guide. As will be appreciated by one of ordinary skill in the art, the elongated guide may be disposed along any suitable axis of the insertion device. For example, the elongated guide may be arranged along the longitudinal axis x of the insertion device or along an axis perpendicular to the longitudinal axis x. Further, as will be understood by one of ordinary skill in the art, the elongated guide may have any suitable shape not limited to the straight path or the curved path shown in the figures and described herein.

Additional aspects related to sliders or other position control structures are discussed in more detail below. For example, the insertion device may be configured to include a plurality of sliders for controlling a plurality of insertion device components. For example, the insertion device may have a bilateral configuration such that the slider or other control structure may be operated from the top or bottom side of the device housing, thereby allowing left or right hand control while still providing the benefits of the improved insertion device of the present disclosure. The insertion device may further be adapted to include additional control structures embedded in the slider itself to allow for the addition of functionality other than controlling sheath or plunger movement. For example, the insertion device may include an IUD wire control structure and a signal structure for indicating the procedure step or position.

As shown in the configuration of the insertion device shown in fig. 8A-8F, the insertion device 800 of the present disclosure includes an elongate sheath 832, a sheath flange 833, an elongate inner member or plunger 834, a slider 842, a housing 835 and an elongate guide 840, the housing 835 comprising a housing top or upper surface 835a and a housing bottom or lower surface 835 b. The slider 842 may be integrally formed from a sheath slider, e.g., such that it operates in a uniform manner, or constructed from a single component attached to or from the elongate sheath 832. However, as will be understood by those skilled in the art, the slider may be attached to the plunger or integrally formed with the plunger without departing from the scope of the present disclosure. The insertion device 800 includes control structure (not shown in fig. 8) for controlling the relative positions of the sheath 832, plunger 834 and IUD. Such position control structures may include slider structures, elongated guide structures, and/or housing structures, including (but not limited to) any of the structures described above. The slider 842 and the housing 835 or the elongated guide 840 each include at least one alignment surface, wherein the surfaces become aligned when the slider is positioned at a position corresponding to a suitable slider position (corresponding to a step defined in the IUD insertion procedure). The slider and housing/elongated guide may further be adapted and configured to include multiple alignment surfaces, wherein different slider and/or housing/elongated guide surfaces are aligned differently during different stages of the IUD insertion procedure, e.g., at different locations along the elongated guide, at different stages of the insertion procedure, or at different times during the insertion procedure.

Turning to fig. 8C, sheath 832 engages slider 842 at the proximal end 10 of the sheath and at the distal end 20 of the slider mechanism. As depicted, the slider 842 has an upper surface 842a, a lower surface 842b, and two side surfaces 842c, 842 d. Upper surface 842a is further characterized by a recess having a length L1 and being sized sufficiently to communicate with a user's finger during use. The recess is further characterized by a first side surface 842e, a second side surface 842f facing the first side surface 842e, and a lower surface 842 g. Plunger 834 engages housing 835 at proximal end 10 of plunger 834 and at the distal end of housing 835. The plunger 834 is an elongate shaft having a first diameter d1 along a distal section s1, a second diameter d2 different from the first diameter d1 along a penultimate section s2, and a third diameter d3 along a proximal section s3, the third diameter d3 being greater than the second diameter and may be the same as the first diameter. As depicted, the housing 835 has an upper surface 843a, a lower surface 843b, and two side surfaces 843c, 843 d. The upper surface 843a is further characterized by a recess having a length L2, length L2 being greater than the length L1 of the slider. The recess or channel is defined by a first side surface 842a, a second side surface 842b facing first side surface 842a, and a lower surface 842 c. As depicted in the configuration of fig. 8, the width of slider 842 is such that it fits within the elongated channel 840 of housing 835.

In the configuration shown in fig. 8A-F, the slider 842 includes at least a first slider surface 842e and at least a second slider surface 842F, and the housing 835 includes at least a first surface 844a and at least a second surface 844 b. Fig. 8D-8F illustrate these position control features of the slider 842 and the housing 835 during different stages of an IUD insertion procedure. Fig. 8D corresponds to step 1, fig. 8E corresponds to step 2, and fig. 8F corresponds to step 3 of the above-described insertion procedure. As the slider 842 is moved along the longitudinal axis x of the insertion device 800 during various IUD insertion stages, the surfaces 842e, 842f of the slider 842 are configured to align with one of the housing surfaces 844a, 844b during at least one procedure step. In step 1, the first slider surface 842e is aligned with the first housing surface 844a, while the second slider surface 842f is misaligned with the second housing surface 844 b. In step 3, the second slider surface 842e is aligned with the second housing surface 844b, while the first slider surface 842f is misaligned with the first housing surface 844 a. Although only two alignment points are shown in fig. 8D-8F, the present disclosure contemplates fewer or more than two alignment points. For example, the insertion device may further include additional sliders and/or housing surfaces that are aligned at step 2 of the insertion procedure. The lower surface 842g of the slider 842 and the lower surface 844c of the housing may be configured such that the depth d4 (the depth established between 835a and 844 c), d5 (the depth established between 842a and 842 g) relative to the upper surfaces 835a, 842a of the housing 835 and slider 842 are the same or similar.

When the corresponding structures (e.g., surfaces 842, 844) are aligned during use, such alignment indicates to the user that the IUD is in the proper position corresponding to the corresponding procedure step. The position control structure may be configured such that the structure is a force limiting (or force absorbing) structure that restricts or inhibits further movement of the slider beyond a prescribed position in the elongate guide. The structure may also be configured to resist excessive force applied by the user to the slider, which may interfere with IUD positioning or even damage the insertion device.

As shown in fig. 9A-9B, the width w of the sheath slider 942 and/or the elongated guide 940 is sufficiently narrow so that a user's finger or thumb can control the slider 942 and move the slider 942 along the elongated guide 940 without being able to move the slider 942 beyond the force limiting structure on the handle 935 or the elongated guide 940. For example, in one aspect, the elongated guide 940, slider 942, and slider surfaces 942a, 942b each have a width that inhibits a user from moving the slider 942 beyond the force limiting structures 944a, 944b of the housing of the handle 935. This limited width prevents the user from moving the slider beyond the alignment point.

The force limiting structure improves IUD position control by preventing the user from moving the IUD out of position. For example, in step 1, which corresponds to fig. 8D and fig. 3A-3D, the force limiting structure 844a prevents a user's force applied to the slider from moving the slider beyond the force limiting structure 844 a. Since the user's thumb is not suitable to be passed beyond the force limiting structure 844a by the elongated guide, the user's thumb abuts the force limiting structure 844a and the slider 842 is not moved distally. As shown in fig. 9A-9B, the user's thumb is prevented from moving away from the force limiting structures 944a and 944B because the width w of the slider 942 and the elongated guide 940 is narrow. Preferably, the width of the elongated guide 940 or slider 942 (or the combined width of multiple sliders) is 0.75 inches (19 mm) or less, 0.7 inches (17.8 mm) or less, 0.5 inches (12.7 mm) or less, 0.35 inches (8.9 mm) or less, or 0.25 inches (6.3 mm) or less.

Any excessive force applied by the user to the slider will be fully transmitted to, or absorbed by, the fixed force limiting structure. As an additional benefit, force limiting structures, such as force limiting structures 844a and 844b, generally prevent undesired movement of the entire insertion device during an insertion procedure. As mentioned above, the alignment or registration of the slider and housing structures may provide a signal to the user indicating that the IUD is in the proper position corresponding to the respective procedure step.

As will be understood by those skilled in the art, the present disclosure contemplates that additional structures and mechanisms may be used for position control in addition to the surfaces and alignment discussed above. The control structure may include additional or different characteristics, as will be appreciated by those skilled in the art. Such position control features of the slider, housing and/or elongated guide may include physical attributes such as shape, different physical structures, angles, contour patterns, colors, sizes or visual symbols that assist the user in precisely controlling the position of the IUD during the insertion procedure. For example, when performing a specified procedure step, the structures may be misaligned, while at other times the structures may be aligned — i.e., misaligned at specified procedure steps 1, 2, and/or 3, with time alignment between the steps. The mechanical structures may also be configured to coincide in ways other than aligning surfaces or other physical structures. In certain aspects, when the prescribed program steps are implemented such that the slider is in the appropriate corresponding position, the insertion device may display to the user a visual signal that only appears when the slider is in the appropriate position corresponding to such program steps. For example, the insertion device may display visual indicators such as pictures, words, characters, numbers, patterns, color variations, etc., as long as the slider position corresponds to a program step (or as long as the slider position does not correspond to a program step). The indicating structure of the insertion device of the present disclosure is discussed in more detail below.

Current devices may be configured to include a handheld insertion device adapted and configured to be inserted into an IUD or IUS, the handheld insertion device including an elongate inner member, an elongate sheath at least partially surrounding or enclosing the elongate inner member, and one or more control structures for controlling various structures of the insertion device. The control structure further may be adapted and configured to include: at least one control structure that controls translational movement of the elongate sheath and the elongate inner member relative to each other along the longitudinal axis; and at least one control structure for controlling one or more wire members of the IUD during the insertion procedure and/or the post-insertion procedure. The wire control structures, mechanisms, and methods of the present disclosure are discussed in more detail below. As will be appreciated by those skilled in the art, any such wire control structure, mechanism, and method may be used in conjunction with the various insertion device designs discussed herein.

In one aspect of the insertion device of the present disclosure, as illustrated by example in fig. 10A-10F, an insertion device 1000 having a proximal end 10 and a distal end 20 comprises a handheld insertion device comprising: an elongate inner member or plunger 1034; an elongate sheath 1032; a handle or housing 1035; a sheath slider 1042 protruding or extending from an upper and/or lower surface of the housing 1035 and adapted and configured to control translational movement of the elongate sheath 1032 and elongate inner member relative to each other along their longitudinal axes in one or more of a proximal direction and/or a distal direction; and at least one thread control structure for controlling one or more threads attached to the IUD (as shown and described above with respect to fig. 2). The string control structure may include, for example, a string control slider 1046, as shown in fig. 10A-10F. As set forth in more detail below, the wire control slider 1046 may be adapted and may be configured to control the securing of the wire, for example, by allowing the locking and unlocking of one or more wires attached to the IUD.

The insertion device housing 1035 provides a housing for the proximal ends of the insertion device components, such as the sheath 1032, plunger 1034, and slider 1042. In addition, the housing 1035 forms a handle configured for an operator to hold the insertion device during use. The housing 1035 includes one or more slider windows or elongated guides 1040a, 1040b that allow a user to access the sliders 1042, 1046. The first elongate guide 1040a provides a guide along which the sheath control slider 1042 can slide or move during operation. Second elongated guide 1040b provides a guide along which string control slider 1046 may slide during operation. The slider 1042 may be a sheath slider physically attached to the sheath 1032 and adapted and configured to control the longitudinal position and translational movement of the sheath 1032 relative to the internal components 1034 and IUDs. During the insertion procedure, the operator uses the thumbs to move the sliders 1042, 1046 along the respective elongated guides 1040a, 1040b of the sliders 1042, 1046, the elongated guides 1040a, 1040b being positioned adjacent to each other and may partially or fully overlap to control both the elongated sheath 1032 and the IUD wire, respectively (not shown in fig. 10).

As can be seen in fig. 10B, the insertion device 1000 includes a bilateral configuration in which the side-by-side sheath control and string control sliders 1042, 1046 are accessible from the top (upper) or bottom (lower) surface/handle 1035 of the housing. The sliders 1042, 1046, which are of a bilateral configuration, allow left-handed and right-handed users to manipulate the insertion device in the same manner. The sheath 1032 comprises a flexible but rigid material that may be shaped or molded for different anatomies of individual patients. The insertion device 1000 may further be configured to include one or more force limiting structures 1044a, 1044b adapted and configured to inhibit a user from applying excessive force to the sliders 1042, 1046. One or more force limiting structures 1044a, 1044b may be configured such that the structures extend above and/or below the upper and/or lower surfaces of the housing. The force limiting structures 1044a, 1044B may also be integrally formed with the housing 1035, as shown in fig. 10A-10B. In at least some configurations, at least one of the force limiting structures acts as a soft stop rather than a hard stop, whereby a user-applied force is limited by the force limiting structure without requiring contact between the insertion device member or insertion device member surfaces. The force limiting structure instead limits the force that a user may apply to one or more sliders by blocking or inhibiting the user's fingers from moving the slider beyond certain points along the longitudinal axis. For example, as shown in fig. 10C, the insertion device 1000 includes a sheath control slider 1042 having a first surface 1042a and a second surface 1042b, a string control slider 1046 having at least a first surface 1046a and a second surface 1046b, and a housing 1035 having a first surface 1044a and a second surface 1044 b. The housing 1035 includes at least one force limiting structure corresponding to the housing surfaces 1044a, 1044 b.

As will be appreciated by those skilled in the art, when the force limiting structure(s) are engaged, the force limiting structure prevents the slider from continuing to move in the distal (anterior) direction. Without the force limiting structure, the slider would continue to move distally (anteriorly).

As shown in fig. 10A-10F, a bilaterally operated insertion device 1000 may be further configured to include a housing 1035, the housing 1035 including one or more storage areas, apertures, cavities, or open structures that surround or cover at least a portion of the one or more sliders 1042, 1046 at one or more locations during certain stages of an insertion procedure. For example, as shown in fig. 10D-E, the distal and proximal force-limiting structures of housing 1035 each comprise a cavity 1045a, 1045 b. In step 1 of the insertion procedure, the sheath slider 1042 is positioned in the first lumen 1045a adjacent to the distal end of the sheath elongation guide 1040 a. In step 3 of the insertion procedure, both the sheath slider 1042 and string control slider 1046 are positioned in the second lumen 1045b adjacent to the proximal ends of the elongate guides 1040a, 1040 b. The insertion device 1000 further includes one or more alignment structures, such as surface structures of one or more sliders and a housing or elongated guide. As shown in fig. 10D, the housing includes a first surface 1044a at a distal end of the sheath elongation guide 1040a and a second surface 1044b at a proximal end of the sheath elongation guide. The sheath slider 1042 includes a first surface 1042a and a second surface 1042 b. As shown in fig. 10E-F, the string control slider 1046 includes a first surface 1046a and a second surface 1046 b. As mentioned above, the alignment or registration of the slider and housing structures may provide a signal to the user indicating that the IUD is in the proper position corresponding to the corresponding procedure step. For example, at step 1, the alignment/position control surfaces 1044a and 1042b are aligned, as shown in fig. 10D. At step 2, surfaces 1042a and 1046a are aligned, as shown in fig. 10E. At step 3, the surfaces 1042a, 1046a and 1044b are aligned, as shown in fig. 10F. As described above, the force limiting structure and the alignment structure are soft motion control structures that do not require physical contact between the insertion device structures or members. Such soft motion control structures prevent undesirable movement of the insertion device during the insertion procedure and promote smooth user movement without interruptions caused by components of the insertion device contacting each other.

As shown in fig. 10C-10F, the alignment of the position control structures or alignment surfaces corresponds to the prescribed procedural steps and the corresponding IUD positions. Additionally, the alignment of these structures provides a force limiting mechanism to further resist movement of the slider caused by the force applied by the user. As shown in fig. 10D, corresponding to the configuration of the insertion device 1000 during step 1 of the insertion procedure, the sheath slider is still in a fully distal position along the longitudinal axis of the elongate guide. The sheath slider first surface 1042a is aligned with the housing first surface 1044a whereby a user's finger can simultaneously contact both aligned surfaces 1042a and 1044 a. The housing first surface 1044a is a force limiting structure whereby a user's fingers will abut the housing first surface 1044a and the user cannot slide the sheath slider 1042 beyond the force limiting structure 1044 a. Preferably, the combined width of the two sliders is sufficiently narrow to prevent a user's finger from entering either cavity 1045a, 1045 b.

As shown in fig. 10E, the sheath slider and string control slider are each in an intermediate position along the longitudinal axis of the elongate guide, corresponding to the configuration of the insertion device during step 2 of the insertion procedure. During steps 1 and 2, the string control slider can be disposed in a separate elongated guide 1040b, and the string control slider can be positioned in a fully distal position on elongated guide 1040 b. As the user slides the sheath slider 1042 rearward along the elongate guide, the sheath slider 1042 approaches the string control slider 1046. Finally, the second surface 1042a of the sheath slider 1042 is aligned with the first surface 1046a of the string control slider, which indicates that the IUD is in place corresponding to step 2.

As shown in fig. 10F, corresponding to the configuration of the insertion device 1000 during step 3 of the insertion procedure, the sheath slider 1042 and string control slider 1044 are in a fully proximal position along the longitudinal axis of the elongate guides 1040a, 1040 b. The sheath slider second surface 1042b is aligned with the string control first surface 1048a, and the user simultaneously slides both the sheath slider and string control slider 1048 back toward the housing second surface 1044 a. Upon reaching step 3 of the insertion procedure, the user's fingers contact both of the aligned surfaces 1042b and 1046a, and the housing second surface 1044 b. The housing second surface 1044b is force limiting in that a user's finger abuts the housing second surface 1044b and the user is thereby unable to slide the first sheath slider surface 1042a and the first line control slider surface 1046a past the force limiting structure 1044 b.

The sheath slider 1042 and string control slider 1046 can be configured such that they can (but need not) be physically attached to each other, and further, the sheath slider 1042 and string control slider 1046 can be configured such that they can translate or slide freely and independently of each other. The combined width of the sheath slider 1042 and string control slider 1046 is of sufficient width to allow a user's finger or thumb to control the slider and move the slider along its respective elongated guides 1040a, 1040 b. In at least some configurations, control and movement are performed simultaneously on the slider. The housing 1035 includes one or more storage areas, cavities, or openings configured to enclose or cover at least a portion of one or more sliders. For example, as shown in fig. 10C, the force limiting structures 1044a and 1044b of the housing 1035 each include a cavity 1045a, 1045 b. In step 1 of the insertion procedure, the sheath slider 1042 is positionable at least partially within the first lumen 1045a adjacent the distal end of the elongate introducer during at least a portion of the procedure. In step 3 of the insertion procedure, both the sheath slider 1042 and string control slider 1046 are positionable at least partially within the second lumen 1045b, adjacent the proximal ends 10 of the elongate guides 1040a, 1040 b. As described above, the force limiting structure of the insertion device 1000 may be a soft motion control structure that does not require physical contact between insertion device structures. Such soft motion control structures prevent undesirable movement of the insertion device during the insertion procedure and promote smooth user movement without interruptions caused by components of the insertion device contacting each other. Additionally, the alignment or registration of the slider and housing structures may provide a signal to the user indicating that the IUD is in the proper position corresponding to the corresponding procedure step.

As shown in fig. 11, the distal (forward) movement limiter of the sheath slider may be configured such that is defined by the distal end 20 of the sheath control elongation guide 1140 and the proximal movement limiter of the sheath control slider 1142 is defined by the proximal end 10 of the sheath control elongation guide 1140. In addition to the sheath control elongate guide 1140, the insertion device 1100 further includes a string control slider 1146 that can be adapted and configured to move within the elongate guide 1140. The string control slider 1146 is configured such that it has two protrusions 1146a, 1146b extending above the upper surface 30 of the handle 1135. Between the two protrusions 1146a, 1146b, a channel 1136c is formed in the wire control slider 1146. When the user slides the sheath control slider 1142 proximally to a position where the user's thumb contacts both the sheath control slider 1142 and the string control slider 1146, the sheath control slider 1142 is sized such that it can slide between the channel 1136c formed in the string control slider 1146. As both the sheath control slider 1142 and the string control slider 1146 are advanced in the distal-most direction 20, the sheath control slider fits within the channel of the string control slider 1146 such that the two sliders create a single profile extending from the housing 1135. In addition, the alignment of the two sliders sends feedback to the user that the sheath is controlling the sliders to be in the proper position for step 2. The feedback may be tactile, visual, or audible. When the user slides both the sheath control slider 1142 and the string control slider 1146 simultaneously during the step 2 to step 3 transition of the insertion procedure, both sliders 1142, 1146 contact the distal end of the elongate guide 1140, thereby inhibiting the user from moving the sliders further in the distal direction. Since the sheath control slider 1142 and the string control slider 1146 are moved by the user simultaneously, distal movement of the sheath slider 1142 is also impeded. This mechanism sends feedback to the user indicating that step 3 of the insertion procedure has been completed.

In another example, the insertion device includes a plurality of sheath sliders or a plurality of string control sliders. Thus, for example, the thread control slider 1146 may be formed of two distinct sliders 1146b, 1146c configured to operate independently, and wherein each slider controls one of the two threads on the IUD device.

In yet another aspect, as shown in fig. 12A-12B, an insertion device 1200 having an elongate sheath 1232 and a handle 1235 includes a sheath slider 1242 and a string control slider 1246 in the handle 1235. As in the configuration depicted in fig. 10A-10F, the sheath slider 1242 slides in the proximal direction 10 and the distal direction 20 along the path defined by the first elongate guide 1240A, and the string control slider 1246 is movable along the path defined by the second elongate guide 1240 b. In this regard, the distal and proximal movement limits of the sliders 1242, 1246 may comprise elongated guide structures, such as hard motion control surfaces 1241a, 1241b, 1241c, 1241d, rather than the cavities of the insertion device 1000 shown in fig. 10A-10F. The distal movement limiter of the sheath slider 1242 is a hard motion control feature 1241a of the elongated guide 1240a, while the proximal movement limiter of the sheath slider 1242 is a hard motion control feature 1241b of the elongated guide 1240 a. The distal movement limiter of the string control slider 1246 is a hard motion control feature 1241c of the elongated guide 1240b, while the proximal movement limiter of the string control slider is a hard motion control feature 1241d of the elongated guide 1240 b.

In step 1 of the insertion procedure (position not shown), the sheath slider 1242 is in a distal-most position at the hard motion control feature 1241a of the elongate guide 1240a and the string control slider 1246 is in a distal-most position at the hard motion control feature 1241c of the elongate guide 1240 b. In step 2 of the insertion procedure (position not shown), the sheath slider 1242 is in an intermediate position located somewhere along the length of the elongate guide, and the string control slider 1246 is in a fully distal position at the hard motion control structure 1241c of the elongate guide 1240 b. In step 3 of the insertion procedure (position not shown), the sheath slider 1242 and the string control slider 1246 are aligned and located at the proximal hard motion control feature 1241d of the elongate guide 1240 b. While the proximal movement limiter of the sheath slider 1242 is configured as the proximal hard motion control feature 1241b of the sheath control elongate guide 1240a, the insertion procedure is completed at step 3 when the sheath slider 1242 is aligned with the proximal hard motion control feature 1241d of the elongate guide 1240 b. An optional hollow area, recess, split, or slit 1248 may be provided in the proximal surface of the grip 1235 into which one or more wires may be retained.

As will be understood by those skilled in the art, the insertion devices of the present disclosure may include any suitable combination of position control structures, including (but not limited to) hard motion control structures, soft motion control structures, force limiting structures, cavities, and the like. For the sake of cleanliness and brevity, all possible combinations of such structures are not discussed in detail herein, but such combinations are included in the insertion devices of the present disclosure.

The insertion devices of the present disclosure may also be configured to include a handheld IUD insertion device that further includes an elongate inner member, an elongate sheath at least partially surrounding or enclosing the elongate inner member, and one or more control structures for controlling various structures of the insertion device. The control structure includes, but is not limited to, at least one control structure that controls translational movement of the elongate sheath and elongate inner member relative to each other along the longitudinal axis in a proximal and/or distal direction, and at least one control structure for controlling one or more wires attached to the IUD during an insertion procedure and/or a post-insertion procedure. The sheath slider and string control slider are configured such that the slider has a telescoping configuration. The wire control structures, mechanisms, and methods of the present disclosure are discussed in more detail below. As will be appreciated by those skilled in the art, any such wire control structure, mechanism, and method may be used in conjunction with the various insertion device configurations discussed herein.

As shown in the example of fig. 13A-13B, the insertion device 1300 includes an elongate sheath 1332, an elongate inner member or plunger (not shown), a handle or housing 1335, at least one elongate guide, a first slider 1342 for controlling translational movement of the elongate sheath 1332 and elongate inner member relative to each other along their longitudinal axes, and a thread control slider 1346 for controlling one or more threads attached to the IUD. The string control structure may include a string control slider 1346, as shown in fig. 13A-13B. As set forth in more detail below, the thread control slider 1346 can control the locking and unlocking of one or more threads attached to the IUD. The insertion device housing 1335 may be adapted and configured to provide a housing for insertion device components, such as the sheath 1332, plunger and sliders 1342, 1346, as well as a handle for an operator to hold the insertion device during operation. The housing 1335 further may be adapted and configured to include slider windows or elongated guides that allow a user to access the sliders 1342, 1346. The elongated guide may be configured to include a plurality of elongated guides 1340a, 1340B as shown in fig. 13A-B, which provide guides 1340 along which the sliders 1342, 1346 may slide during operation. As will be appreciated by those skilled in the art, the movement of the slider along the one or more elongated guides may be performed simultaneously and/or separately at any given time during the procedure. As shown, the slider 1342 is a sheath slider that is attachable to the sheath 1332 and directly controls the longitudinal position and translational movement of the sheath 1332 relative to the elongate inner member and IUD. The slider 1346 is a wire control slider (e.g., a wire unlock or wire release slider). During the insertion procedure, the operator moves both sliders 1342, 1346 with the thumb proximally and distally along the respective elongated guides 1340a, 1340b to control the sheath 1332 and the IUD wire, respectively. As can be seen in fig. 13B, the insertion device 1300 may be configured to include a bilateral configuration in which the sliders 1342, 1346 are accessible from either the top (upper) face or surface 30 or the bottom (lower) face or surface 40 of the handle 1335. Further, the telescoping slider configuration allows for left or right handed user operation without the need for a bilateral configuration of slider controls on both the top and bottom of the handle/housing.

As shown in fig. 13A-B, the sheath slider 1342 and the string control slider 1346 each slide in a proximal or distal direction along the longitudinal axis along the elongated guide. At the distal end of the guide is a housing having a cavity 1345 into which at least a portion of the slider can be advanced. The sliders 1342, 1346 have a telescopic configuration whereby at least one slider slides within or through at least one other slider along a longitudinal axis. As will be understood by those skilled in the art, while the sheath slider 1342 slides through the wire control slider 1346 in the configuration shown in fig. 13A-13B, the present disclosure also includes designing the wire control slider 1342 to slide within the sheath slider 1346 or through the sheath slider 1346.

In an alternative configuration, the first slider may comprise a plunger slider rather than a sheath slider. The telescopic configuration of the slider allows for a compact and small insertion device that is streamlined. In addition, this configuration may help the user avoid confusion because the slider moves along the same path in the elongated guide. As with the previous examples, an optional hollow region, recess, split or slit 1348 may be provided in the proximal surface of the handle 1335 into which one or more wires may be retained.

The insertion device 1400 of fig. 14A-14B is similar to the insertion device 1300 of fig. 13A-13B, but the insertion device 1400 can be further configured to include a first cavity 1445a and a second cavity 1445B in the handle 1435. At step 3 of the insertion procedure, the sheath slider 1442 and the string control slider 1446 are in a fully proximal 10 position along the longitudinal axis of the elongate guide 1440 and are at least partially surrounded by the proximal cavity 1445 b. Additional visual indicating structures 1460, 1460', 1460 ″ are displayed. Visual indication structures may be provided on the elongate sheath 1432, the handle 1435, or both. Numerals 1, 2 and 3 on the insertion device member provide the user with a visual indication as to the proper position of the insertion device member during various stages of the insertion procedure. Visual indicators such as numbers may be applied in any suitable manner including, but not limited to, printing, etching, embossing, engraving, and the like. Furthermore, the visual indicators may be positioned such that they are only visible during certain aspects of the procedure and not visible during other aspects of the procedure.

As with other configurations discussed above, the alignment of certain control structures or surfaces may be configured to correspond to a prescribed procedural step and corresponding IUD position, for example, as shown in fig. 15A-15C. As shown in fig. 15A, it is depicted that the insertion device 1500 will be configured during step 1 of the insertion procedure such that the sheath slider 1542 is in the fully distal position 20 along the longitudinal axis of the elongate guide 1540. As shown in fig. 15B, fig. 15B depicts the insertion device 1500 configured during step 2 of the insertion procedure such that the sheath slider 1542 and the string control slider 1546 are each in a neutral or intermediate position along the longitudinal axis of the elongate guide relative to the proximal and distal ends of the elongate guide 1540, in a position between the distal and proximal ends of the elongate guide. In transitioning from step 1 to step 2, as the user slides the sheath slider 1542 proximally along the elongate guide 1540, the sheath slider 1542 approaches the string control slider 1546 and slides under and through the cavity in the string control slider 1546 in a telescoping manner.

As shown in fig. 15B, a surface of the sheath slider 1542 is aligned with a surface of the string control slider 1546 to form a smooth interface where the user's thumb contacts both sliders simultaneously or substantially simultaneously. As shown in fig. 15B, in step 2, the first sheath slider surface 1542a and the first cord control slider surface 1546a are aligned, which indicates that the IUD is in place corresponding to step 2. In step 3, as shown in fig. 15C, the alignment of the first sheath control slider surface 1542a and the first cord control surface 1546a allows the user to simultaneously move both sliders synchronously from step 2 to step 3, corresponding to the configuration of the insertion device 1500 during step 3 of the insertion procedure. As shown in fig. 15C, the sheath slider 1542 and the string control slider 1546 are in a proximal position along the longitudinal axis of the elongate guide 1540 corresponding to the configuration of the insertion device during step 3 of the insertion procedure. As the slider is retracted proximally, the second sheath controls slider surface 1542b against the proximal elongate guide surface 1540 b.

As discussed above, the insertion devices of the present disclosure may include one or more sliders (such as string control sliders) to control the string release structure, and a sheath or plunger slider to control translational movement of the elongate sheath and elongate inner member relative to each other along their longitudinal axes. As discussed above, the insertion device may include one or more elongated guides in which the slider slides along the longitudinal axis of the insertion device. In the above configuration, a simple slider and elongate guide configuration has been discussed for clarity and brevity. In the above configurations, such as those shown in fig. 6, 8, and 10-15, slider movement may cause a simple direct translational movement of the corresponding insertion device member — for example, a sheath slider may be directly attached to the sheath, whereby when the sheath slider is moved rearwardly a given distance, the sheath is also moved rearwardly the same distance. As will be appreciated by those skilled in the art, the insertion devices of the present disclosure contemplate additional mechanisms for operating the control structure. The insertion devices of the present disclosure may include any number of a variety of different operating mechanisms for converting a user's input motion into translational or rotational movement of an insertion device member, such as those available and known in the art. For example, the insertion device may include a crank system, a piston system, a rotary system, an oscillating lever system, a pawl system, a rack and pinion system, a gear system, a hydraulic system, a spring system, a Geneva (Geneva) mechanism system, and the like, as well as combinations of any such systems.

In one general type of construction, as shown in fig. 16A-16C, the insertion device includes a slider 1642 positioned within the elongate guide 1640, the slider 1642 controlling the attachment system 1650. The configuration shown in fig. 16A-C may be configured to reduce the total travel required by a user to achieve various positions during use of the device. As will be understood from reviewing the drawings, a travel multiplier may be implemented such that a given user movement is amplified and thus the user needs to make fewer actual movements on the slider. Thus, the movement achieved in the handle is not 1:1 with the movement achieved at the distal end of the device. In the configuration shown in fig. 16A-16C, the linking system includes one or more rods 1651, 1651', 1651 ″ and pins 1652, 1652', 1652 ″. The linkage system is attached to a translating member, such as a sheath, plunger, or string control structure. As shown in fig. 16A-16C, the slider 1642 moves along the elongate guide 1640 and the slider controls the attachment system 1650, the attachment system 1650 attaches to the sheath 1632 and moves the sheath 1632. As will be understood by those skilled in the art, the linking system member is adjustable to correspond to the target distance that the sheath moves during, for example, stages 1, 2 and 3 of the IUD insertion procedure. In the aspect shown in fig. 16A-16C, the joining system 1650 is fixed at the proximal end of the joining system 1650, and the joining system 1650 is attached to the sheath at the distal end of the joining system 1650.

A similar aspect is shown in fig. 17A-17C. Crank system 1750 is characterized by one or more rods 1751, 1751 'and pins 1752, 1752', 1752 ″. However, in this configuration, crank system 1750 engages slider 1742 at its distal end 20 and gear 1753 at its proximal end 10. A crank system is positioned within handle 1735 and at least a portion of crank system 1750 operates within elongated guide 1740. The crank system 1750 may further be configured to include a rotary dial component or gear 1753 attached to a proximal end of the crank system 1750 to limit or control movement of the proximal end of the crank system 1750. As gear 1753 rotates about the central axis, the longitudinal position of sheath control slider 1742 moves proximally as the gear moves in the counterclockwise direction, as shown in fig. 17A-C. The illustrated pivot point 1752 ″ may be configured such that it remains stationary during the movement depicted in fig. 17. With the pivot point 1752 ″ held fixed, the overall linear movement required by the user is reduced. This facilitates one-handed operation by the user during use.

In another general type of configuration, as shown in fig. 18A-18B, the insertion device 1800 includes a lever 1842 attached to a gear system 1855, the gear system 1855 including a first gear 1856, wherein the first gear 1856 moves a second gear 1857, wherein the second gear 1857 is attached to the sheath 1832. When the insertion device operator actuates the lever 1842, such as by pressing on the lever, the first gear 1856 moves the second gear 1857 proximally, thereby moving the sheath 1832 proximally. The insertion device 1800 may further include a spring (not shown) attached to the lever 1842, wherein the spring (not shown) provides a counter force to the input force applied by the user to the lever 1842. The insertion device 1800 may further be configured to include a detent mechanism whereby the spring returns the lever 1842 to its starting position without moving the sheath distally.

In another embodiment, as shown in fig. 19A-19B, the insertion device 1900 includes at least one gear or rack 1957 attached to a lever 1942 positioned within a housing of a handle 1935. When lever 1942 is pressed by the operator, gear 1957 moves pawl 1958 attached to sheath 1932, whereby gear 1957 moves the sheath proximally.

In other embodiments, as shown in fig. 20A-20D, 21A-21D, and 22A-22C, the insertion device includes position control structures, such as buttons 2042, 2046, that exhibit vertical movement but non-longitudinal movement along the elongate guide. In this manner, the insertion device operator can press one or more buttons downward to activate the position control structure. For example, as shown in fig. 20A-20D, the insertion device includes a first button 2042 and a second button 2046, the first button 2042 being a sheath position control button and the second button 2046 being a wire control button in the housing 2035. The wire control button starts a wire unlocking structure; exemplary wire control structures are discussed in more detail below. As shown in fig. 20A-20D, in step 1, a first button is pressed downward to retract the sheath. In step 2, a surface of the first button and a surface of the second button are aligned. In step 3, both the first and second buttons are pressed downward to retract the sheath and activate the wire control structure, such as the wire unlocking structure. After step 3 is complete, the surface of the button may be aligned with the housing 2035, the housing 2035 providing a force limiting structure to prevent further downward movement of the button. In other embodiments, further movement of the button is prevented by a hard stop or a soft motion control structure, such as the structures discussed in detail in the detailed description of the specification. As shown in fig. 20A-20D, the buttons may telescope relative to each other, whereby the first button moves through or within the second button. The embodiment illustrated in fig. 21A-21D is similar to the embodiment illustrated in fig. 20A-20D, except that the sheath position control button 2142 and the string control button 2146 are located side-by-side in the housing 2135, rather than in a telescoping configuration.

Fig. 22A-22C illustrate an actuation mechanism for the sheath position control button depicted in fig. 20A-20D and 21A-21D, according to an example embodiment of the present disclosure. As shown in fig. 22A-22C, sheath control button 2242 positioned in housing 2235 contacts sheath structure 2232r during one or more stages of the insertion procedure. For example, the sheath structure may include a ramp or angled surface. When the operator presses the button down, the input force is transferred from the button to the structure or surface 2242a of the button. Button structure or surface 2242a pushes on sheath structure 2232r and moves the sheath in a rearward direction. Additionally or alternatively, the insertion device may be configured to push the plunger distally rather than proximally as will be appreciated by those skilled in the art. As can be seen in fig. 22A-22C, button structure 2242A moves along a ramp or angled surface 2232r, thereby simultaneously allowing button 2242 to move downward and sheath 2232 to move longitudinally. This mechanism of action is a non-limiting example of an embodiment contemplated by the present disclosure. Any suitable structures and mechanisms are included in the present disclosure, as will be understood by those skilled in the art. For example, the insertion device may include a gear system to simultaneously allow downward movement of the sheath position control structure and longitudinal movement of the sheath.

As described above, maintaining a low profile dome shape at the distal end of the insertion device may prevent or reduce trauma during the insertion procedure, as well as prevent or reduce premature disengagement of the IUD from the insertion device during the insertion procedure. In certain insertion device embodiments, in order to pass through the cervix without increased resistance, the insertion device must be positioned at the distal tip of the tube such that the arms and hands of the IUD are squeezed together and an atraumatic configuration is formed at the tip of the insertion device. The insertion devices of the present disclosure may further be adapted to include one or more dimensional motion control structures associated with the sheath and/or plunger to provide enhanced control over the distance between the plunger, sheath and IUD such that the IUD is reliably held in place during one or more steps of the insertion procedure. Alternatively or in addition to the position control structures associated with the slider, elongate guide and housing discussed above, the sheath and/or plunger may include separate position control structures attached directly to or associated with the sheath or plunger itself. These structures may include dimensional motion control structures to precisely control the distance between the tip of the plunger and the tip of the sheath. For example, as shown in the example embodiment of fig. 23A-23C, the insertion device may include a sheath 2332 and a plunger 2334, wherein one or both of the plunger 2334 and the sheath 2332 each include one or more position control structures associated therewith. For example, plunger 2334 can include a first motion control structure 2338, first motion control structure 2338 having a first motion control surface 2338a and a second motion control surface 2338b on an opposite surface. Plunger 2334 may further include a second motion control structure 2339, second motion control structure 2339 having a first motion control surface 2339 a. As depicted, first motion control surface 2338a of first motion control structure 2338 is configured to face toward or oppose first motion control surface 2339a of second motion control structure 2339. Sheath 2332 further can be adapted and configured to include one or more first motion control structures 2336 having a first motion control surface 2336a configured to face first motion control structure 2338a of first motion control structure 2338 of plunger 2334 and an opposing second motion control surface 2336b configured to face first motion control structure 2339a of second motion control structure 2339 of plunger 2334. Sheath 2332 further can be adapted to include additional motion control structures, such as one or more second motion control structures 2337a at the distal end, and one or more third motion control structures 2337b positioned proximally relative to the second motion control structures. As will be understood by those skilled in the art, the motion control structures 2336, 2337 shown in the cross-sections shown in fig. 23a-c may be different structures placed at intervals on the inner surface of the sheath or may form a continuous ring around the inner surface of the sheath.

As shown in fig. 23A-23C, various position or motion control structures and various motion control surfaces are positioned at different locations along the longitudinal axis of the insertion device 2300. Much like the position control structures discussed above, these structures may be adapted to correspond to various stages of an IUD insertion procedure. These motion control structures or motion control surfaces may be configured to control the position of the insertion device members during insertion, including the relative positions of the IUD, sheath and plunger.

For example, in step 1 of the insertion procedure shown in fig. 23A, the proximal surface of distal plunger motion control structure 2338 contacts the distal surface of first sheath motion control structure 2336 such that first motion control surface 2338a of distal plunger motion control structure 2338 contacts first motion control surface 2336a of sheath first motion control structure 2336, thereby preventing further proximal direction movement of the plunger and preventing further distal direction movement of the sheath. In this manner, motion control surfaces 2336a and 2338a are hard motion control surfaces relative to each other. As will be appreciated by those skilled in the art, these structures or surfaces may also include soft motion control structures or surfaces that merely impede, rather than inhibit, further movement. For example, as shown in fig. 23D-E, the sheath 2332 includes one or more distally positioned soft motion control structures 2337a, 2337 b. In operation, for the device depicted in fig. 23D, the sheath 2332 includes at least one motion control structure 2337c, which is a cut-out or detent that can conform to the shape or contour of the IUD or a portion thereof. For example, the detents 2337c allow the IUD hand (not shown) to rest therein and properly align the IUD along the longitudinal axis of the sheath 2332. In addition, one or more detents 2337a may be positioned at a limited location positioned in-plane around the inner perimeter of the sheath 2332 to properly align the IUD arms in-plane prior to deployment into the patient.

In step 2 of the insertion procedure shown in fig. 23B, the sheath 2332 is retracted in a proximal direction (or the plunger is advanced distally) such that the sheath first motion control structure 2336 is proximate to the proximally located or second plunger motion control structure 2339. The insertion device 2300 can be configured to include one or more additional motion control structures, such as a second sheath motion control structure 2337a and a third sheath motion control structure 2337 b. These motion control structures may be soft motion control structures that merely impede further movement of the sheath 2332 and plunger 2338 relative to each other and/or provide an indication, such as tactile feedback, to the insertion device operator that the insertion device 2300 has achieved an intermediate stage of the insertion procedure. The soft motion control structures 2337a, 2337b may further be configured to correspond to IUD positions in step 2, as shown in fig. 4C and described above. These structures provide a signal to the insertion device operator that the IUD arm is deployed from the sheath. As shown in fig. 23B, one or more sheath soft motion control structures 2337a may be positioned distally along the sheath relative to the first sheath motion control structure 2336 and/or one or more sheath soft motion control structures 2337B. In addition, the motion control structure 2336b can be positioned proximally along the sheath 2332 relative to the first sheath motion control structure 2336. These motion control structures provide a small resistance against the plunger 2338 after the insertion device 2300 is advanced through step 2 and into step 3. This may be accomplished by minimizing the size or length of the first and second plunger motion control structures 2336, 2339 along the longitudinal axis of the plunger 2334, as shown in fig. 23D and 23E. In this manner, only a short length or portion of the plunger 2334 will contact the resistive soft motion control structures 2337a, 2337b, 2337 d. For example, plunger motion control structures 2336, 2339 may be configured to have a length similar to the length of sheath soft motion control structures 2337a, 2337b, or may have a shape, such as a curved shape or a circular shape, that minimizes contact between plunger motion control structure 2338 and soft motion control structure 2337 d.

In step 3 of the insertion procedure shown in fig. 23C, sheath 2332 is further retracted proximally (or the plunger is advanced distally) and proximal plunger motion control structure 2339 contacts first sheath motion control structure 2336 such that first motion control surface 2339a of proximal plunger motion control structure 2339 contacts second motion control surface 2336b of sheath first motion control structure 2336 thereby preventing further proximal direction movement of the plunger and preventing further distal direction movement of the sheath. In this manner, motion control surfaces 2336b and 2339a are hard motion control surfaces relative to each other. As will be appreciated by those skilled in the art, these structures or surfaces may also include soft motion control structures or surfaces that merely impede, rather than inhibit, further movement.

As will be understood by those skilled in the art, the present disclosure includes variations of the example embodiments shown in fig. 23A-23C. For example, the sheath and/or plunger may include any suitable number of motion control structures, which may include any suitable number or arrangement of motion control surfaces. As discussed above with respect to the position control structures of the slider, elongate guide, and housing, the plunger and/or sheath motion control structures may include any suitable type of hard motion control structure, soft motion control structure, or any suitable combination thereof. For example, the motion control structure or surface may include a physical structure such as a detent, notch, groove, protrusion, bump, ridge, flange, flap, gate, flexible member, profile, curve, shape, or the like. Additionally, while the motion control structure or surface is preferably proximal to the distal or forward end of the insertion device, such structure or surface may be suitably located at any suitable location along the longitudinal axis of the sheath and plunger.

With these plunger and sheath motion control structures, loading the plunger and IUD into the sheath prior to insertion can be achieved by preloading the members during manufacture of the insertion device. Additionally, the motion control structure may be arranged such that the motion control structure is aligned in a first position, then misaligned in a second position (which may be achieved after rotating one or more of the plunger and sheath relative to each other), thereby allowing loading of the IUD and plunger into the sheath by first rotating the member, then sliding the plunger motion control structure past the sheath motion control structure, and finally rotating the member again to realign the plunger and sheath motion control structure such that they are aligned during the insertion procedure. In another embodiment, the IUD may be loaded into an opening in the side wall of the housing/handle or sheath, as discussed in more detail below.

In yet another embodiment, the insertion device may be adapted to include a plunger having structure for locking the IUD in place to prevent the IUD from moving relative to the plunger along a longitudinal axis of the insertion device during one or more stages of an insertion procedure. For example, the plunger may include structure to grasp or grip the IUD during at least the first insertion stage, and optionally during the second and third stages. For example, the plunger may grasp or grip the IUD near the wire at the proximal end of the IUD, or the IUD wire. The insertion device may further comprise an IUD unlocking structure. For example, the sheath may include structure that unlocks the IUD from the plunger as the sheath is moved during step 2 or step 3 or after step 3.

The insertion device of the present disclosure may further be adapted to include structure that provides an atraumatic distal or anterior end or tip of the insertion device to minimize pain caused by the insertion device as it passes through the patient's cervix and into the uterus, as well as during withdrawal of the insertion device from the patient after IUD insertion. The insertion devices of the present disclosure may also be adapted to include structures that minimize the cross-sectional dimension of the distal end of the insertion device during insertion, as well as reduce or eliminate blunt or abrupt structures at the distal end of the insertion device that may cause pain or discomfort to the patient as the insertion device passes through the cervix during use.

The insertion device can also be configured to include a sheath 2432 having a tapered or rounded distal end or tip 2432t, wherein the cross-section or outer diameter D of the insertion device sheath decreases from a proximal value toward the distal end or tip of the insertion device, as shown in fig. 24A-24G. The sheath tip 2432t tapers or may taper towards the distal end of the sheath 2432, as shown in fig. 24A-24B. As shown in fig. 24B, the thickness T of the sheath 2432 wall can also be minimized at the distal-most end of the sheath 2432 to reduce the impact of the sheath wall thickness on the patient. The thickness of the sheath wall may be reduced at the distal end of the sheath relative to the thickness measured at different locations along the longitudinal axis of the sheath 2432. Keeping the thicker sheath wall away from the distal-most end of the sheath will allow the sheath to be suitably rigid, while decreasing the sheath wall thickness near the sheath tip 2432t will minimize any abrupt structures that may scratch or pinch the patient during insertion. As shown in fig. 24C, the end 2432e of the sheath wall can be further rounded to minimize blunt or abrupt structures of the insertion device. The insertion device sheath 2432 can also include an opening 2432o, as shown in fig. 24A-24C.

In another general type of embodiment, as shown in fig. 24D-24F, the sheath end 2432t is formed such that the IUD is substantially or completely covered by the sheath 2432 during an initial stage of the insertion procedure, e.g., when the insertion device is passed through the cervix. At this initial stage of the procedure, the device can be configured such that the sheath has no or almost no opening at the sheath end 2432 t. The tip may be formed as part of a sheath, as shown in fig. 24D. Alternatively, as shown in fig. 24E, the sheath tip may include a separate member, such as a sheath cap or cover 2432c that fits over the sheath 2432 or slides over the sheath 2432 to cover the end of the sheath during insertion. Preferably, the sheath cover has a thinner thickness than the sheath wall, but is made of a material that is strong enough to accommodate the IUD during insertion. The sheath cover may be made of the same material as the sheath material, or the sheath and cover may comprise different materials. The cap may be configured to attach to the sheath by mechanical force or chemical adhesion, including suitable attachment methods known in the art. As will be appreciated by those skilled in the art, if the diameter of the tapered tip is smaller than the diameter of the opening of the external opening of the cervix, and then gradually increases in diameter along its length to accommodate the IUD, the tip may be advanced through the external opening and as the diameter of the device increases, the device will exert lateral pressure on the wall of the cervix, so that the opening of the cervix slowly increases in diameter to accommodate the remainder of the device.

In another example embodiment, as shown in fig. 24F, the insertion device includes an outer cannula or sheath 2432a and at least one inner sheath 2432 b. The IUD 2402 is received by the inner sheath 2432b and the inner sheath slides into the outer sheath 2432a in a telescoping manner so that the inner sheath and IUD can be loaded into the outer sheath to prepare the insertion device for an IUD insertion procedure. The example embodiment shown in fig. 24F depicts an inner sheath 2432b that includes a tapered or rounded sheath tip 2432 t. However, as will be understood by those skilled in the art, the inner sheath and/or the outer sheath may be configured to include a sheath tip 2432 t. Preferably, the interface i between the sheath and cap of fig. 24E, or the inner sheath and outer sheath of fig. 24F, is a seamless interface that does not pinch, scratch, stick, or otherwise injure the patient during the insertion procedure. For example, a seamless interface may be achieved by matching the outer diameters of the two components at interface i, e.g., matching the outer diameters of the sheath 2432 and sheath cap 2432c at interface i shown in fig. 24E, or matching the outer diameters of the external sheath 2432a and internal sheath 2432b at interface i shown in fig. 24F-G. In the embodiment shown in fig. 24F, the inner sheath 2432b can include a lip 2432l that allows the outer diameter of the inner sheath 2432b to match the outer diameter of the outer sheath 2432a while allowing the inner sheath to slide within the outer sheath along the portion of the inner sheath below the lip 2432 l. In another example embodiment (not shown), the interface may be located at a distance along the longitudinal axis of the insertion device that is sufficiently far from the distal end of the sheath that the interface does not enter the patient's cervix during the insertion procedure.

Because the sheath and plunger motion control features are small (either because they are positioned inside the sheath or because they are affixed to the plunger), the insertion device can be configured to include one or more force limiting features, such as those discussed above, to prevent a user from applying excessive force to the slider, which could subsequently damage or destroy the sheath and plunger motion control features.

Wire locking and unlocking structure

As described above, the insertion devices of the present disclosure include one or more string control structures or mechanisms. The wire control structure may include one or more wire locking structures and at least one wire unlocking structure or mechanism. The one or more wire control structures or mechanisms may include manual structures, automated structures, or combinations thereof.

In one general type of configuration, as shown in fig. 25A-25B and 26A-26E, the insertion device may be adapted to include a three-dimensional structure, such as an opening, detent, notch, wedge, or split 2548, wherein one or more IUD wires (not shown) may be securely engaged within the three-dimensional structure. The three-dimensional wire locking structure may be formed in the insertion device housing 2535, or may be formed as part of another suitable insertion device component. In one example embodiment, after loading the IUD into the insertion device, the insertion device operator may pull the IUD wire into the stereoscopic wire locking structure 2548. In additional embodiments, the wire may be automatically placed or locked in a wire locking structure, as discussed in additional embodiments below. One or more wire locking structures may be used to control the position of the IUD during insertion and/or to move the wire away to prevent the wire from interfering with the insertion procedure. Additional advantages will be appreciated by those skilled in the art. After IUD insertion is complete, the wire may be manually, automatically or semi-automatically removed from the locking structure 2548.

In addition to the at least one wire locking structure, the insertion device includes one or more wire unlocking structures to remove the wire from the locked position. The one or more unlocking structures may include manual and/or automated line unlocking structures. As shown in the example embodiment of fig. 26A-26E, the insertion device can include a movable wire control structure 2649 that pushes or releases the wire from the wire locking structure 2648. As shown in fig. 26A-26E, the insertion device includes a movable wire release structure that is movable past or through the wire locking structure 2648. As discussed above and shown in fig. 26A-26E, the wire locking structure may include an opening or a dimensional structure that is inserted into the device housing 2635. When the wire unlocking feature 2649 is in the first position, the wire remains locked in the wire locking feature 2648. When the wire unlocking structure 2649 is moved, the wire is released or unlocked by the wire unlocking structure 2649.

As in the example embodiment shown in fig. 26A-26C, the insertion device can include a feature 2649 that is both a wire locking feature and a wire unlocking feature. For example, the wire control structure 2649 may be configured to lock the IUD in place by clipping the wire against the housing 2635 to a first position (not shown). For example, a wire may be clipped or locked into wire locking structure 2648 by wire control structure 2649. When the wire control structure is moved (e.g., pushed proximally), as shown in fig. 26A, the wire is released from the wire locking structure 2648 because the wire locking and unlocking control structure 2649 no longer pinches or locks the wire against the housing 2635, the wire locking structure 2648, or another inserter device member. As shown in fig. 26A, the housing or wire locking structure 2648 and/or the wire unlocking structure 2649 may include angled or sloped surfaces that contact the surfaces of the wire locking structure 2648 when the wire is locked and do not contact when the wire is unlocked.

In the example embodiment shown in fig. 26D-26E, the wire locking structure 2648 locks or controls the wire into a three-dimensional structure in the insertion device housing 2635, and the wire unlocking structure 2649 releases, or unlocks the wire when the wire unlocking structure 2649 is moved from a first position (as shown in fig. 26D) to a second position (as shown in fig. 26E). For example, the wires may be positioned such that they extend beyond or protrude through the proximal end of the insertion device through openings in the wire unlocking structure 2649. For example, construct 2649 may comprise a hollow tube portion through which a wire may be passed. In this embodiment, the wire is pulled securely out of the opening in the structure 2649 and into the locking structure 2648. As the wire unlocking feature 2649 is moved proximally, the unlocking feature 2649 pushes the wires to remove them from the locking feature 2648. As will be understood by those skilled in the art, these non-limiting exemplary embodiments are shown to illustrate wire control structures contemplated by the present disclosure and include additional embodiments and operating mechanisms, such as the additional embodiments discussed in this specification.

The wire control structure 2649 (which may be a wire locking and/or wire unlocking structure) may be further configured to be controllable by a wire control structure, such as a slider 2646, as shown in fig. 26D-26E. As shown in fig. 26D, the string control structure 2646 includes a slider position return structure 2646r that allows a user to move the slider 2646 back to its starting position. The slider position return structure may include a spring, a detent, a bump, or any other suitable structure, as will be understood by those skilled in the art. The string control structure 2646 can be adapted to include a telescoping string control slider, such as in the illustrated embodiment of fig. 13-15, as discussed in more detail above. Alternatively or additionally, the line control structure 2649 can be controlled by one or more line release buttons 2647, as shown in fig. 26B (top view) and 26C (side view). Button 2647 may be located in or on the housing in a position separate from sheath control slider 2642, as shown in fig. 26B-26C. The at least one button 2647 may include a slider, a depressible button, or any other suitable control structure or mechanism for moving the wire unlocking structure 2649. String control structure 2649 can be adapted and configured to include an elongated member that is physically attached to or operatively connected to one or more string control structures, such as string release slider 2646 or string release button 2647.

FIGS. 27A-27C show additional details of the insertion device 800 shown in FIGS. 8A-8F and described in more detail above. In one configuration, as shown in fig. 27A-27C, the insertion device includes a wire control structure 2747, the wire control structure 2747 including one or more stereoscopic wire locking structures 2748. The wire locking structures 2748 can be configured such that each structure includes a surface 2748a adapted and configured to clamp or lock one or more IUD wires 2710, the IUD wires 2710 extending from within the elongate sheath 2732 against another member or surface of the insertion device. The wire locking structure 2748 or surface 2748a can be formed from a ramp, curved surface, angled surface, rounded structure, depression, protrusion, or other suitable three-dimensional structure. The wire control structure 2747 provides both a wire locking and wire unlocking mechanism. The IUD wire is locked or constrained in the first position, or unlocked or unconstrained when the wire control structure is moved from the first position to the second position. When the wire control structure 2747 is in a first position, as shown in fig. 27C, at least one IUD wire 2710 can be locked or constrained in place by the wire locking structure 2748, wherein a surface 2748a of the structure 2748 clamps, squeezes, or constrains the wire against another member or surface (not shown) of the insertion device, such as an inner surface of the handle 2735. When the wire control structure 2747 is moved to the second position, as shown in fig. 27C, the wire is released from the locked position. The wire locking structure 2748 includes a curved or angled surface to allow for gradual locking or binding of the insertion device as the curved or angled surface moves across the wire. The wire control structure 2747 can be moved through a series of motions from the locked position to the unlocked position by sliding, rotating, or otherwise moving the structure 2747.

In yet another embodiment, the insertion device includes a wire locking structure that includes one or more grooves or teeth that catch and lock the wire in place, thereby gripping the wire against the grooves or teeth and another surface of the insertion device. For example, as shown in fig. 28, the wire locking structure 2847 includes a first member having teeth 2848a on at least one surface thereof. The wire locking structure 2847 can further include a second member having at least one surface with teeth 2848b, wherein the teeth of the first member face the teeth of the second member. Moving the wire locking structure 2847 toward the second member surface 2848b causes the two surfaces having teeth to engage or clamp the wire 2810 positioned between the surfaces, thereby locking the wire in place. In one embodiment, the wire is locked or constrained by depressing the wire control structure 2847 and released or unlocked by releasing the wire control structure 2847. In other embodiments, the wire may be locked by another structure, such as a latch or hinge that secures the surfaces 2848a, 2848b together. In still other embodiments, the wire control structure 2847 is moved by sliding or rotating the wire control structure 2847, wherein the wire is sandwiched between a first surface and a second surface of the wire control structure 2847, wherein the first surface and/or the second surface comprises teeth or grooves. As will be appreciated by those skilled in the art, the wire control mechanism may be adapted to secure the wire in the first position and then release the wire, or may be adapted to control the tensioning of the wire relative to the IUD during deployment by constraining the wire or wires prior to releasing the wire. Thus, all wire locking and unlocking structures and mechanisms may be adapted to lock, restrain, tension or release (partially or fully) the wire of the engagement mechanism.

In still other embodiments, the wire locking and unlocking structure or mechanism may be adapted to include a hinge or clip structure, wherein the wire is locked when the hinge or clip is closed or tightened and unlocked when the hinge or clip is opened or loosened.

In yet another embodiment, the insertion device may be configured to include one or more mechanisms that prevent a user from deploying the IUD while the wires remain in the locked or constrained position. Such a configuration may be advantageous to prevent pain associated with the insertion procedure when the device operator pulls on the deployed IUD wire (e.g., when retracting the insertion device after insertion while the insertion device is attempting to maintain the wire locked). By requiring that the wires be unlocked prior to insertion of the device, which will allow for full deployment of the IUD, the resistance structure provides the operator with a feedback mechanism, signal or reminder that the wires need to be unlocked prior to performing the procedure.

In one example embodiment, as shown in fig. 29A-29D, the insertion devices disclosed herein can be configured to include a wire locking and unlocking structure 2947 that includes one or more alignment structures 2960. 29A-29D, the IUD wire is locked and unlocked by the wire control structure 2947. Line 2910 passes through aperture 2948. For example, sliding or rotating the wire control structure 2947 can lock and unlock the wire, depending on the direction in which the structure is moving or rotating. When the wire is locked or clamped by the wire locking structure 2947, as shown in fig. 29B, the wire control structure 2947 exhibits an interface that prevents the sheath from advancing beyond the wire control structure interface. For example, the sheath can include one or more stereoscopic structures 2961, such as tabs or protrusions, that align with one or more structures 2960 of the string control structure 2947, such as the openings 2960, 2960' shown in fig. 29A-29D. When the wire is locked, the sheath structures 2961, 2961 'are misaligned with the openings 2960, 2960' in the wire locking structure 2947 and the sheath 2932 cannot be retracted, as shown in fig. 29B. When the wire is unlocked, the sheath structures 2961, 2961 'are aligned with the openings 2960, 2960' in the wire locking structure 2947 and the sheath can be retracted, as shown in fig. 29C-29D.

In yet another embodiment, the insertion device includes a wire cutting structure. The wire cutting structure may be a wire unlocking structure in which the wire is cut by the cutting structure of the insertion device and thereby released from the locked position. Alternatively, the wire cutting structure may be separate from the wire unlocking structure. As will be appreciated by those skilled in the art, the wire cutting structure may comprise a blade or any known mechanism suitable for cutting or severing an IUD wire.

Manual, automatic, or semi-automatic line locking or unlocking structures are contemplated in the insertion devices of the present disclosure. By combining any of the above-mentioned structures, the insertion device can be configured to include an automatic wire locking structure, wherein the wire is automatically locked and unlocked by the insertion device without requiring additional procedural steps or user input. The automatic locking and unlocking structure may comprise any suitable structure or mechanism known in the art, and the structures of the present disclosure are discussed herein. For manual procedures, when the device is in the correct or desired position or configuration, such as when a dome shape is achieved, the user pulls on the wire and then positions one or more wires into the split such that the split walls grip the wire, thereby locking the wire in place.

V. feedback structure

As described above, the insertion devices of the present disclosure may be adapted and configured to include one or more indicator or signal structures that provide a sensory signal to a user that the IUD and other insertion device components are in a suitable or targeted position corresponding to one or more stages of an IUD insertion procedure. Sensory indicator structures or user feedback of the present disclosure include, but are not limited to, visual indicators (such as the visual alignment structures described above), audible indicators (such as clicks or other noises heard by the insertion device operator), and/or tactile indicator structures that are perceptible to the operator, such as tactile indicators perceptible to the operator's fingers or thumb (e.g., when one member of the device engages another member, such as occurs in a configuration characterized by a soft motion control structure).

The insertion device may further be configured to include one or more signaling structures that are used to alert the operator to various stages of the insertion procedure or to ensure that the IUD is properly positioned, thereby signaling the operator to perform the next step in the procedure. Again, such guidance may inform the clinician of the improper positioning of the IUD by the lack of the aforementioned positive signal indicating proper IUD positioning, or by including additional negative signal structures. The insertion device includes a non-visual indicator structure, such as a tactile or audible indicator structure. In this manner, the insertion device provides an indicator that eliminates the need for the user to look back out of the patient towards the insertion device, whereby the user can focus on the patient during insertion.

In additional aspects of the disclosure, the insertion device may be adapted to display a visual indicator symbol, such as a picture, a word, a number, a pattern, a color change, etc., when the IUD position corresponds to a procedure step (or, conversely, when the IUD position does not correspond to a procedure step). As shown in fig. 30A-30B, the indicating structure of the insertion device may include a symbol 3070, the symbol 3070 depicting an IUD positioning corresponding to the procedure step and the insertion device positioning. For example, the slider 3042 may include an observer window 3071 that displays symbols depicting the corresponding IUD positioning at various slider positions. When the operator moves the slider 3042, the window aligns with and displays the appropriate symbol printed or molded onto the inserter housing or another inserter member, the symbol corresponding to the configuration of the IUD and/or the configuration of the IUD and inserter at the corresponding procedure step.

IUD Loading before insertion

The present disclosure includes various structures and related methods for preparing an insertion device for an IUD insertion procedure. For example, the IUD3102 is loaded into the housing or sheath 3132 through one or more openings 3132h in an insertion device sheath, including an outer sheath 3132a or an inner sheath 3132B, as shown in fig. 31A-31B.

In an additional aspect, as shown in fig. 32A-32B, the IUD 3202 and the plunger 3234 are simultaneously loaded into the insertion device through an opening 3235h in the insertion device housing 3235. The plunger 3234 can be adapted and configured to include one or more structures 3234f for attaching the plunger 3234 to the housing 3235 after loading the plungers 3234 and 3202 into the insertion device. As shown in fig. 32B, the insertion device may be further adapted and configured to include a hub or inner sheath 3232B, the hub or inner sheath 3232B providing a loading sheath to fold the IUD 3202 to load the IUD 3202 into the insertion device. The hub or inner sheath 3232b can include one or more stop features 3232c for stopping the travel of the hub 3232b into the outer sheath 3232a as the plunger 3234 passes through the housing and into the outer sheath 3232 c. For example, the stop feature 3232c can be configured to include a three-dimensional structure, such as a protrusion, that contacts a surface within the housing 3235 and prevents the bushing from moving further. The IUD may be a T-shaped IUD, or any other IUD configuration pre-packaged such that the IUD arms are in an extended position. The hub may be slid over the IUD prior to loading of the IUD to fold the IUD arms together to load the IUD into the insertion device.

On the other hand, the handle or housing top and bottom parts may be separated or opened to allow loading of the plunger and IUD. For example, the housing may include a hinge that allows the housing to open in a swinging manner to load the IUD.

In yet another aspect of the disclosure, the sheath or plunger position control structure allows the sheath or plunger to move to load the IUD into the sheath for insertion. For example, the IUD may be loaded into the insertion device sheath by advancing the sheath distally to cover the IUD prior to insertion. The insertion device may include a sheath slider positioned at a second intermediate position along the elongate guide prior to IUD insertion. While the IUD is locked to the plunger or housing, the slider is moved distally to advance the sheath distally and cover the IUD arms. The insertion procedure then begins with the sheath slider in the first distal position. Step 2 of the insertion procedure comprises moving the sheath slider back to a second intermediate position, and step 3 comprises moving the sheath slider back along the elongate guide to a third proximal position.

While aspects of the present disclosure have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the disclosure. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary aspects, but should be defined only in accordance with the following claims and their equivalents. As will be appreciated by those skilled in the art, any of the foregoing device or process components may be used in any suitable combination to form the insertion device of the present disclosure.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. An insertion device, comprising:

an elongate sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end;

an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath;

a proximally-positioned user interface, wherein the proximally-positioned user interface further comprises a housing, the proximally-positioned user interface having one or more elongated guides formed at least partially therein and along at least a portion of a length of the proximally-positioned user interface, wherein the one or more elongated guides are channels formed in the housing; and

a movable sheath slider in communication with the elongate sheath, wherein the movable sheath slider is adaptable and configurable to reliably move within the elongate guide, and further wherein the movable sheath slider controls axial movement of the elongate sheath, wherein the elongate guide further comprises one or more motion control structures along a length of the elongate guide, and further wherein the one or more motion control structures of the elongate guide comprise at least one force limiting structure configurable to limit an amount of force applied to the movable sheath slider.

2. The insertion device of claim 1, wherein the one or more motion control structures are selected from the group consisting of hard motion control structures, soft motion control structures.

3. The insertion device of claim 2, wherein the one or more motion control features are selected from the group consisting of detents, notches, grooves, bumps, ridges, flanges, flaps, gates, flexible members, elongated guide profiles, and elongated guide curved surfaces.

4. The insertion device of claim 1, wherein the elongated guide has a length, a width, and a depth, and further wherein the width of the elongated guide is at least one of: a variable that varies along the length; a segment width selected from the first width and the second width.

5. The insertion device of claim 1, wherein the elongated guide has an in-plane profile selected from the group consisting of rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semi-circular, and oval.

6. The insertion device of claim 1, wherein the sheath slider comprises one or more surface profiles adapted and configured to mechanically complement the one or more motion control structures.

7. The insertion device of claim 6, wherein the one or more surface profiles of the sheath slider are selected from the group consisting of one or more of a curved surface and an angled surface.

8. The insertion device of claim 1, wherein the housing and the sheath slider further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the housing are adapted and configured to mechanically complement the one or more alignment surfaces of the elongated sheath.

9. The insertion device of claim 8, wherein the first sheath slider alignment surface is aligned with the first housing alignment surface at a first location along the length of the elongated guide.

10. The insertion device of claim 8, wherein the one or more sheath slider alignment surfaces and the one or more housing alignment surfaces are selected from the group consisting of curved surfaces, angled surfaces, and inclined surfaces.

11. The insertion device of claim 1, wherein the elongated guide further comprises one or more cavities on one or more of a proximal end of the elongated guide and a distal end of the elongated guide, wherein the one or more cavities are adapted and configured to receive at least a portion of the movable sheath slider.

12. The insertion device of claim 1, further comprising a string control slider.

13. The insertion device of claim 12, wherein the string control slider is adapted and configured to securely move within the elongated guide.

14. The insertion device of claim 12, wherein the elongate sheath slider and the string control slider are adapted and configured to operate simultaneously and/or independently within one or more elongate guides.

15. The insertion device of claim 12, wherein the sheath slider and the string control slider are telescopically movable along at least a first portion of the elongated guide, and further wherein the sheath slider and the string control slider are configurable such that at least one of the sheath slider and the string control slider partially surrounds the remaining slider.

16. The insertion device of claim 12, wherein the sheath slider and string control slider are further configurable to include one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group consisting of a first sheath slider vertical surface, a second sheath slider vertical surface, a first string control slider vertical surface, and a second string control vertical surface, wherein one or more of the vertical surfaces are configured to form aligned adjacent surfaces at one or more locations along the length of the elongate guide.

17. The insertion device of claim 12, wherein the sheath slider and the string control slider have a combined width of less than or equal to 0.75 inches.

18. The insertion device of claim 1, wherein the insertion device is configurable to receive an IUD within the distal end of the lumen of the elongated sheath, the insertion device further comprising at least one wire locking structure adaptable and configurable to secure one or more wire members of the IUD.

19. The insertion device of claim 18, wherein the at least one wire locking feature comprises one or more of a cleft, a clip, a wedge, a pincher, a spring, or a tooth.

20. The insertion device of claim 19, comprising at least one string unlocking feature, wherein the string locking feature comprises a split and the string unlocking feature comprises a movable member that pushes the one or more strings out of the split to unlock the one or more strings.

21. The insertion device of claim 1, wherein the distal end of the elongated sheath has an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip.

22. The insertion device of claim 21, wherein the distal end of the elongated sheath has an outer diameter of 3 mm to 5 mm.

23. The insertion device of claim 21, wherein the distal end of the elongated sheath has an outer diameter equal to or less than 80%, 50%, 30% of the outer diameter of the proximal end of the elongated sheath.

24. The insertion device of claim 21, wherein the distal end of the elongated sheath has an outer diameter that is less than a maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath.

25. The insertion device of claim 21, wherein the distal end of the elongated sheath further comprises one or more slits or flaps at the anterior end of the elongated sheath.

26. The insertion device of claim 1, further comprising one or more feedback mechanisms selected from the group consisting of an audible feedback mechanism, a visual feedback mechanism, and a tactile feedback mechanism.

27. An insertion device, comprising:

a housing;

an elongate inner member having a proximal end and a distal end disposable within at least a portion of the lumen of the elongate sheath;

a proximally positioned user interface;

an actuatable sheath control button associated with the proximally-positioned user interface in communication with the elongate sheath; and

an elongate guide and one or more motion control structures along the length of the elongate guide,

wherein the actuatable sheath control button is adapted and configurable to control axial movement of the elongate sheath, wherein the elongate sheath extends distally from the housing, and wherein the actuatable sheath control button retracts the elongate sheath proximally when the actuatable sheath control button is actuated, and further wherein the one or more motion control features comprise at least one force limiting feature configurable to limit an amount of force applied to the actuatable sheath control button.

28. The insertion device of claim 27, wherein the one or more motion control features are selected from the group consisting of hard motion control features, soft motion control features.

29. The insertion device of claim 27, wherein the one or more motion control features are selected from the group consisting of detents, notches, grooves, bumps, ridges, flanges, flaps, gates, flexible members, elongated guide profiles, and elongated guide curved surfaces.

30. The insertion device of claim 27, wherein the elongated guide has a length, a width, and a depth, and further wherein the width of the elongated guide is at least one of: a variable that varies along the length; and a segment width selected from the first width and the second width.

31. The insertion device of claim 27, wherein the elongated guide has an in-plane profile selected from the group consisting of rectangular, S-shaped, C-shaped, U-shaped, W-shaped, circular, semi-circular, and oval.

32. The insertion device of claim 27, wherein the actuatable sheath control button comprises one or more surface profiles adapted and configured to mechanically complement the one or more motion control structures.

33. The insertion device of claim 32, wherein the one or more surface profiles of the actuatable sheath control button are selected from the group consisting of one or more of a curved surface and an angled surface.

34. The insertion device of claim 27, wherein the housing and the actuatable sheath control button further comprise one or more alignment surfaces, wherein the one or more alignment surfaces of the housing are adapted and configured to mechanically complement the one or more alignment surfaces of the elongated sheath.

35. The insertion device of claim 34, wherein the first alignment surface of the actuatable sheath control button is aligned with the first alignment surface of the housing at a first location along the length of the elongated guide.

36. The insertion device of claim 34, wherein the one or more alignment surfaces of the actuatable sheath control button and the one or more alignment surfaces of the housing are selected from the group consisting of curved surfaces, angled surfaces, and angled surfaces.

37. The insertion device of claim 27, wherein the insertion device is configurable to receive an IUD within a distal end of a lumen of the elongated sheath, and wherein the insertion device further comprises at least one of: a wire locking structure and a wire control button that may be adapted and configured to secure one or more wire members of the IUD.

38. The insertion device of claim 37, wherein the at least one wire locking feature comprises one or more of a cleft, a clip, a wedge, a pincer, a spring, or a tooth.

39. The insertion device of claim 38, comprising at least one string unlocking feature, wherein the string locking feature comprises a split and the string unlocking feature comprises a movable member that pushes the one or more strings out of the split to unlock the one or more strings.

40. The insertion device of claim 37, wherein the sheath control button and the string control button are disposable adjacent to each other on the housing.

41. The insertion device of claim 37, wherein the combined width of the sheath control button and the string control button is less than or equal to 0.75 inches.

42. The insertion device of claim 37, wherein the sheath control button and the string control button are configurable such that at least one of the sheath control button and the string control button partially surrounds the remaining buttons.

43. The insertion device of claim 37, wherein two or more of the sheath control button, the string control button, and the housing are further configurable to include one or more vertical surfaces, wherein the one or more vertical surfaces are selected from the group consisting of a first sheath control button vertical surface, a second sheath control button vertical surface, a first string control button vertical surface, and a second string control button vertical surface, a first housing vertical surface, and a second housing vertical surface, wherein one or more of the vertical surfaces are configured to form aligned adjacent surfaces at one or more locations along the length of the housing.

44. The insertion device of claim 27, wherein the distal end of the elongated sheath has an atraumatic tip selected from the group consisting of a rounded tip and a tapered tip.

45. The insertion device of claim 32, wherein the distal end of the elongated sheath has an outer diameter of 3 mm to 5 mm.

46. The insertion device of claim 33, wherein the distal end of the elongated sheath has an outer diameter equal to or less than 80% of the outer diameter of the proximal end of the elongated sheath.

47. The insertion device of claim 32, wherein the distal end of the elongated sheath has an outer diameter that is less than a maximum cross-sectional dimension of an IUD positionable within the lumen of the elongated sheath.

48. The insertion device of claim 32, wherein the distal end of the elongated sheath further comprises one or more slits or flaps at the anterior end of the elongated sheath.

49. The insertion device of claim 27, further comprising one or more feedback mechanisms selected from the group consisting of an audible feedback mechanism, a visual feedback mechanism, and a tactile feedback mechanism.

50. A kit, comprising:

an insertion device having an elongate sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally-positioned user interface, wherein the proximally-positioned user interface further comprises a housing, the proximally-positioned user interface having one or more elongated guides formed at least partially therein and along at least a portion of a length of the proximally-positioned user interface, wherein the one or more elongated guides are channels formed in the housing; and a movable sheath slider in communication with the elongate sheath; and

an intrauterine device positionable within the distal lumen of the elongate sheath,

wherein the moveable sheath slider of the insertion device is adapted and configurable to securely move within the elongate guide, and further wherein the moveable sheath slider controls axial movement of the elongate sheath, wherein the elongate guide further comprises one or more motion control features along the length of the elongate guide, and further wherein the one or more motion control features of the elongate guide comprise at least one force limiting feature configurable to limit the amount of force applied to the moveable sheath slider.

51. A kit, comprising:

an insertion device having a housing and an elongate sheath having a proximal end and a distal end, and a lumen extending between the proximal end and the distal end; an elongate inner member having a proximal end and a distal end disposable within the lumen of the elongate sheath; a proximally positioned user interface; and an actuatable sheath control button associated with the proximally-positioned user interface in communication with the elongate sheath; and an elongated guide and one or more motion control structures along the length of the elongated guide, an

wherein the actuatable sheath slider is adapted and configurable to control axial movement of the elongate sheath, wherein the elongate sheath extends outwardly from the housing, and wherein the actuatable sheath control button proximally retracts the elongate sheath when actuated, and further wherein the one or more motion control features comprise at least one force limiting feature configurable to limit an amount of force applied to the actuatable sheath slider.