HK40004730A

HK40004730A - Kit for use in a laparoscopic procedure

Info

Publication number: HK40004730A
Application number: HK19128216.9A
Authority: HK
Inventors: 哈给‧魏斯布罗德; 俄德‧艾莉西
Original assignee: 戈尔迪手术有限公司
Priority date: 2013-09-17
Filing date: 2019-08-15
Publication date: 2020-04-29

Description

Set for laparoscopic surgery

Related application

The present application is a divisional application having application number 201480057286.5(PCT application number PCT/IL2014/050833), application date 2014, 9 and 17, entitled "trocar and wound closure device".

Technical Field

The present invention, in some embodiments thereof, relates to a trocar, and more particularly, but not exclusively, to a trocar and external cannula assembly for use in laparoscopic procedures.

Background

Laparoscopic surgery typically involves the use of a trocar to guide a laparoscope or other surgical instrument through an incision port in the abdominal wall. After surgery, various techniques may be used to provide wound closure, with or without visual control. Proper closure of the port is important for preventing complications such as hernia (hernias).

The following publications disclose a trocar wound closure device:

in european patent publication EP0568098a2 Greenwald et al disclose a "trocar wound closure device (10) comprising an elongated body (12) having a distal end (20) for insertion through a trocar puncture wound; a proximal end (14); a first (70) and second (72) retractable needle holders (needle holders) disposed at the distal end (20) of the body (12). The needle holder (70,72) is movable between a retracted position and an extended position. An actuator (32) disposed at the proximal end (14) of the body (12) moves the needle holder (70,72) from the retracted position to the extended position such that the needle holder (70,72) is retractable to allow the device (10) to be inserted through a trocar wound, preferably through a cannula inserted into the wound, and extends to position the plurality of needle tips (56,58) adjacent the wound to allow the wound to be sutured.

U.S. patent No. 8109943 to Boraiah et al disclose "systems and methods for suture anchoring arrangements. One system according to the present invention is a trocar system including a cannula assembly that provides a needle tip assembly and an obturator assembly that provides a needle tip actuation mechanism. The obturator assembly is at least partially insertable into the cannula assembly and is configured to operatively connect the needle tip actuation mechanism to the needle tip assembly. The needle tip assembly includes at least one needle tip, each needle tip having a suture anchor disposed proximate a distal end thereof. A method according to the present invention includes steps for positioning and/or placing at least one suture anchor in or through a body organ.

Disclosure of Invention

According to an aspect of some embodiments of the present invention there is provided a trocar adapted for insertion through a fascia layer of an abdominal wall, the trocar comprising: a proximal end configured for operation by a user; a distal end configured for insertion into tissue; and a shaft extending between the proximal end and the distal end; wherein the shaft includes a narrow portion proximate the distal end, the narrow portion defining at least one recess shaped and dimensioned to receive fascia tissue, the recess terminating at a distal end of the recess, and a generally proximal-facing surface of the shaft being configured to be directly beneath the narrow portion, the proximal-facing surface and the narrow portion being shaped and dimensioned to stabilize the trocar within the abdominal wall via the fascia. In some embodiments, the proximal-facing surface includes a tissue-engaging geometry configured to limit movement of the fascia tissue received in the recess away from the recess. In some embodiments, a length of the narrow portion is between 0.5 and 30 millimeters, and wherein the depression begins at a distance of at least 0.5 millimeters from a longitudinal axis of the shaft, the depression having a depth of at least 1 millimeter in a radial direction. In some embodiments, a total cross-sectional area of the narrow portion is at least 50% less than a total cross-sectional area of at least one of a shaft portion disposed above the narrow portion and another shaft portion disposed below the narrow portion, the generally proximally facing surface being defined on the another shaft portion. In some embodiments, the narrow portion is sufficiently long to accommodate a portion of fascial tissue having a thickness of at least 0.5 mm. In some embodiments, the shaft is cylindrical and the at least one recess is circumferential. In some embodiments, a shaft portion disposed directly below the narrow portion has a diameter greater than a diameter of a wound in the fascia layer, such that when the narrow portion is positioned in the fascia, tissue that has been stretched by the shaft portion during insertion springs back around the trocar. In some embodiments, the tissue-engaging geometry of the generally proximal-facing surface comprises one or more protrusions. In some embodiments, the protrusions have a plurality of ends oriented in a direction toward the fascia, the ends piercing the fascia to increase resistance. In some embodiments, a shaft portion disposed above the narrow portion includes a tapered or hemispherical profile to increase in diameter in the proximal direction to provide increased resistance during insertion of the device into the abdominal wall. In some embodiments, the trocar comprises: at least one anchoring barb element advanceable distally relative to the shaft of the trocar, and an anchoring advancement mechanism. In some embodiments, the anchor advancement mechanism comprises a sliding element operably coupled to a handle for manipulation by a user, the sliding element comprising a geometry adapted to distally advance the at least one anchor piercing element when advanced into the shaft of the trocar. In some embodiments, the trocar includes a spring and the at least one anchor piercing element is automatically retracted by the spring, the spring configured to not prevent advancement of the anchors into the tissue. In some embodiments, the trocar further comprises: at least one suture anchor, and a suture connected to the anchor, configured to provide wound closure. In some embodiments, the trocar includes at least one proximally facing cutting element positioned distal to the narrow portion, the cutting element being shaped to interact with the anchor to assist the anchor in penetrating the tissue. In some embodiments, the trocar further comprises one or more needle tips for disposing a suture in a tissue, the plurality of needle tips positioned within a shaft portion of a trocar disposed below the narrow portion, a distal end of the plurality of needle tips facing in the proximal direction. In some embodiments, the generally proximal facing surface includes an expandable structure that, when expanded, increases contact with fascial tissue facing the abdomen. In some embodiments, the expandable structure comprises: a closed configuration for inserting or removing the trocar; and an open configuration for preventing the trocar from being pulled away from the fascia in the proximal direction. In some embodiments, the structure is transformable into its open configuration to abut the fascia layer by pulling the trocar in the proximal direction. In some embodiments, the expandable structure defines at least one framework through which an anchor is disposed in the tissue. In some embodiments, the expandable structure includes a set of plurality of wings rotatable between a closed position and an open position, wherein the plurality of wings extend radially outward relative to the shaft to define the framework. In some embodiments, the expandable structure includes a set of a plurality of arms configured to be compressed axially toward one another to define the frame. In some embodiments, a distal tip of the trocar is sufficiently sharp to form the puncture wound upon insertion of the trocar into the abdominal wall. In some embodiments, a distal shaft portion of the trocar includes one or more recesses shaped to form a tissue fold when the trocar is inserted into the tissue, the tissue fold being formed between the anchor and at least one of the narrow portion and the recessed shaft portion disposed below the narrow portion.

According to an aspect of some embodiments of the present invention there is provided a kit for use in a laparoscopic procedure, the kit comprising: a trocar; an outer cannula sized to receive the trocar, the cannula comprising: at least one of anchors and sutures removably attached to an inner wall of the cannula; wherein the trocar includes an anchor advancement mechanism comprising at least one anchor piercing element configured to extend outwardly to a shaft of the trocar to engage the anchor of the outer cannula and advance the anchor into the tissue. In some embodiments, the anchoring barbed element is shaped as a rod, and wherein a distal surface of the rod engages a proximal surface of the anchor. In some embodiments, the kit further comprises a plurality of outer cannulas into which the trocar can be inserted. In some embodiments, a connection between the plurality of anchors and the outer cannula is configured to not interfere with insertion and advancement of the trocar into a ready-to-use position in which the anchor piercing element is substantially positioned over the anchor. In some embodiments, the anchor advancement mechanism is housed within a shaft of the trocar until manipulated to advance the anchor into tissue. In some embodiments, the anchor advancement mechanism further comprises a sliding element operably coupled to a handle for manipulation by a user, the sliding element comprising a geometry adapted to urge the at least one anchor piercing element distally when advanced into the shaft of the trocar. In some embodiments, the plurality of anchors are configured to apply a force to the tissue when advanced into the tissue without directly piercing the tissue, forming a tissue fold between the anchor and at least one of the narrow portion and the recessed shaft portion configured below the narrow portion. In some embodiments, the anchoring comprises: a hollow body shaped and dimensioned to receive an anchoring barbed element; and at least one surface adapted to abut the fascia in a deployed position of the anchor. In some embodiments, the trocar includes at least one proximally facing cutting element positioned distal to the narrow portion, the cutting element being shaped to interact with the anchor to assist the anchor in penetrating the tissue. In some embodiments, the trocar includes a plurality of recesses along the plurality of walls of the shaft in which the plurality of anchoring spur elements are advanced or retracted, the plurality of recesses being configured to be parallel to a longitudinal axis of the shaft. In some embodiments, the trocar includes a spring and the plurality of anchor barbed elements are automatically retracted with the spring, the spring configured to not prevent advancement of the plurality of anchors into the tissue. In some embodiments, an inner wall of the outer sleeve includes at least one elongate recess in which at least a portion of the anchor is received, the recess defining a path for advancing the recess toward the tissue. In some embodiments, the recess is trapezoidal and defines a dovetail-like coupling between the anchor and the sleeve. In some embodiments, at least one of the plurality of anchors and the plurality of sutures may be absorbed in tissue. In some embodiments, a lumen of the outer sleeve is sized for delivering a laparoscopic port therethrough. In some embodiments, the kit further comprises a sleeve for spatially orienting the trocar within the outer cannula. In some embodiments, the sleeve seals a lumen between the trocar and cannula to prevent escape of gas from within the abdomen. In some embodiments, a maximum diameter of the shaft together with the outer sleeve is between 15 to 30 millimeters.

According to an aspect of some embodiments of the present invention there is provided an external cannula for positioning within an abdominal wall, the cannula comprising: at least one anchor removably attached to said cannula; at least one suture connected to the anchor; an axially extending lumen sized to receive a trocar configured to engage the at least one anchor.

According to an aspect of some embodiments of the present invention, there is provided a method for providing at least one of a plurality of suture anchors and a plurality of sutures at a fascia layer of an abdominal wall, the method comprising the steps of: positioning a trocar adapted to be inserted into an abdominal wall such that a surface defined by a narrow portion of a shaft of the trocar abuts a surface of fascia facing the abdomen and the narrow portion is surrounded by fascia tissue; disposing at least one of a plurality of suture anchors or a plurality of sutures in the fascia. In some embodiments, at least one of the plurality of suture anchors and plurality of sutures is disposed at a predetermined depth relative to the fascia layer. In some embodiments, the step of positioning further comprises: pulling the trocar in the proximal direction to slightly stretch the fascia tissue to abut the surface defined beneath the narrow portion. In some embodiments, a single trocar is inserted into multiple outer cannulas, each positioned at a different port, to position multiple suture anchors at each port, respectively.

According to an aspect of some embodiments of the present invention, there is provided a method for providing perceptible feedback to a user for positioning a trocar adapted for insertion into an abdominal wall, the trocar including a shaft formed with a narrow portion proximate a distal end of the trocar, the method comprising: the method comprises the following steps: inserting the trocar through an abdominal wall; pulling the trocar in the proximal direction until resistance is encountered, the resistance being created by a surface of the shaft defined below the narrow portion abutting a fascia layer to the abdominal wall; and positioning the trocar such that the fascia layer enters one or more recesses defined by the narrow portion. In some embodiments, the method further comprises: a plurality of anchors are provided at the fascia layer.

According to an aspect of some embodiments of the present invention, there is provided a method of increasing a distance between a plurality of suture anchors during deployment of the plurality of suture anchors in tissue, the method comprising the steps of: crimping said tissue to a substantially upside down U-shape; piercing the curled tissue at a plurality of bases of the upside down U-shape using the plurality of suture anchors and disposing the plurality of anchors in the tissue; releasing the tissue fold such that the plurality of suture anchors are disposed at a greater distance from each other than a distance between the plurality of suture anchors obtained without the tissue fold. In some embodiments, the crimping step is achieved by advancing the plurality of suture anchors prior to piercing the tissue to push the tissue into a recess of an anchor deployment device.

According to an aspect of some embodiments of the present invention there is provided a device adapted for insertion into a fascia layer of an abdominal wall, the device comprising: a proximal end configured for operation by a user; a shaft including a distal end configured for insertion into tissue; at least one anchor for placement within the tissue, the anchor being removably connected to the shaft; wherein the distal end of the shaft includes a proximally facing element that interacts with the anchor to assist the anchor in piercing the tissue by contacting the tissue from two substantially opposite directions. In some embodiments, the proximal-facing element comprises a proximal-facing cutting edge or tip.

According to an aspect of some embodiments of the present invention there is provided a device suitable for insertion through a puncture wound of at least 3 mm diameter of a fascia layer of an abdominal wall, the device comprising: a proximal end configured for operation by a user; a shaft lever; and a distal end configured for insertion into tissue; wherein the shaft includes a narrow portion proximate the distal end, the narrow portion having a length in the range of 0.5-20 mm, the narrow portion defining at least one recess beginning at a distance of at least 0.5 mm from a longitudinal axis of the shaft, the recess having a depth of at least 1 mm in a radial direction for receiving at least a portion of fascia tissue, the at least a portion of fascia tissue springing back around the shaft. In some embodiments, a periphery of the narrow portion is smaller than a periphery of at least one of a shaft portion disposed above the narrow portion and a shaft portion disposed below the narrow portion. In some embodiments, a total cross-sectional area of the narrow portion is at least 50% less than a total cross-sectional area of at least one of a shaft portion disposed above the narrow portion and another shaft portion disposed below the narrow portion. In some embodiments, the narrow portion is sufficiently long to accommodate a portion of fascial tissue having a thickness of at least 0.5 mm. In some embodiments, the shaft is cylindrical. In some embodiments, the at least one recess is disposed circumferentially around the shaft. In some embodiments, the narrow portion has a diameter that is less than a diameter of a wound in the fascia layer such that tissue that has been stretched by the shaft portion springs back around the narrow portion. In some embodiments, a surface defined by and below the narrow portion facing in a proximal direction comprises one or more protrusions. In some embodiments, the protrusions have a plurality of ends oriented in a direction toward the fascia, the ends piercing the fascia to increase resistance. In some embodiments, the protrusions are circumferentially distributed around a circumference of the surface. In some embodiments, a geometry of the device provides an indication of a current depth of the device relative to tissue to a user. In some embodiments, a shaft portion disposed above the narrow portion includes a tapered profile to increase in diameter in the proximal direction to provide increased resistance during insertion of the device into the abdominal wall. In some embodiments, the distal end of the device is provided with a blade for cutting a puncture wound in the fascia. In some embodiments, the distal end is non-bladed. In some embodiments, a pulling force of up to 40N may be applied to the device without causing a proximally facing surface of the shaft defined below the narrow portion to return through a wound in the tissue, the surface being larger than the wound to resist the pulling. In some embodiments, the shaft includes a hollow lumen for inserting the device over a guidewire. In some embodiments, a proximal facing surface of the shaft defined below the narrow portion includes an expandable structure configured to abut a surface of the abdominal facing fascia. In some embodiments, the expandable structure includes a plurality of segmented leaves (leafs). In some embodiments, the expandable structure includes a closed configuration for insertion or removal of the trocar; and an open configuration for preventing the trocar from being pulled away from the fascia in the proximal direction. In some embodiments, the structure is transformable into its open configuration to abut the fascia layer by pulling the trocar in the proximal direction. In some embodiments, a distance between a surface defined below the narrow portion and the distal end is in a range between 10 to 50 millimeters. In some embodiments, the device comprises at least one of a plurality of sutures and a plurality of suture anchors for placement in the fascia to provide wound closure. In some embodiments, during deployment, at least one of a distance between the narrow portion and a distal end of the device and a range of distances of the plurality of suture anchors determines a position of at least one of the plurality of sutures and suture anchors relative to the fascia. In some embodiments, the device includes a plurality of anchoring spur elements for delivering the plurality of anchors toward the fascia. In some embodiments, the shaft includes a plurality of recesses along the plurality of walls of the shaft for receiving the plurality of anchoring stab elements. In some embodiments, the plurality of recesses are disposed parallel to a longitudinal axis of the shaft. In some embodiments, the recess is arcuate such that the plurality of anchors are disposed at an angle relative to a longitudinal axis of the shaft. In some embodiments, the device further comprises a spring, and the plurality of anchoring spike elements are automatically retracted by the spring. In some embodiments, the device further comprises a cannula external to the device. In some embodiments, the cannula includes at least one of a suture and a suture anchor. In some embodiments, the plurality of sutures pass through the plurality of anchors. In some embodiments, at least one of the plurality of anchors and the suture may be absorbed in tissue. In some embodiments, the outer sleeve is sized for laparoscopic passage. In some embodiments, the device comprises an anchored applicator according to a ratchet (ratchet). In some embodiments, the ratchet prevents upward movement of the anchoring spur element during anchoring deployment. In some embodiments, the device further comprises a sleeve for spatially positioning the device within the outer cannula. In some embodiments, the sleeve seals a lumen between the trocar and cannula to prevent escape of gas from within the abdomen. In some embodiments, the device further comprises one or more needle tips for disposing a suture in a tissue. In some embodiments, the plurality of needle tips are positioned within a shaft portion of a trocar disposed below the narrow portion, a distal end of the plurality of needle tips facing in the proximal direction. In some embodiments, the device includes a removal configuration wherein the plurality of needle tips are retracted along the device while the suture remains within the tissue. In some embodiments, the tissue is a fascia layer.

According to an aspect of some embodiments of the present invention, there is provided a method for providing at least one of a plurality of suture anchors and a plurality of sutures at a fascia layer of an abdominal wall, the method comprising the steps of: positioning a trocar adapted for insertion into an abdominal wall to provide wound closure such that a surface defined by a narrow portion of a shaft of the trocar abuts a surface of fascia facing the abdomen and the narrow portion is surrounded by fascia tissue; and disposing at least one of a plurality of suture anchors or a plurality of sutures in the fascia. In some embodiments of the present invention, the,

the plurality of suture anchors and the plurality of sutures are disposed at a predetermined depth relative to the fascia layer. In some embodiments, the step of positioning further comprises: pulling the trocar in the proximal direction to slightly stretch the fascia tissue to abut the surface defined beneath the narrow portion. In some embodiments, the device is inserted into an outer cannula, and the disposing step includes pushing anchors positioned on the outer cannula to advance toward the fascia. In some embodiments, a single trocar is inserted into multiple outer cannulas, each positioned at a different port, to position multiple suture anchors at each port, respectively.

According to an aspect of some embodiments of the present invention, there is provided a method for providing perceptible feedback to a user for positioning a trocar adapted for insertion into an abdominal wall, the device including a shaft formed with a narrow portion proximate a distal end of the device, the method comprising the steps of: inserting the device through an abdominal wall; pulling the device in the proximal direction until resistance is encountered, the resistance being created by a surface of the shaft defined below the narrow portion abutting a fascia layer to the abdominal wall; and positioning the device such that the fascia layer springs back around the narrow portion. In some embodiments, the apparatus is for an anchoring arrangement, and the method further comprises: a plurality of anchors are provided at the fascia layer. In some embodiments, the increased resistance is provided by the proximally facing shaft surface comprising one or more protrusions that pierce the fascia.

Unless defined otherwise, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and/or materials are described below. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to necessarily limit the respective examples.

Drawings

The invention is herein described, by way of example only, with reference to the accompanying drawings. Referring now in specific detail to the drawings, it is important that the details shown are by way of example only to illustrate and discuss embodiments of the present invention. In this regard, it will be apparent to those skilled in the art how embodiments of the present invention may be practiced in detail, when taken with the accompanying drawings.

In the drawings:

FIG. 1 is a drawing of a distal portion of a trocar according to some embodiments of the present invention;

FIG. 2 is a flow chart of a method for inserting a trocar and external assembly into a tissue to set an anchor according to some embodiments of the present invention;

FIGS. 3A-3K are a set of diagrams illustrating an operational procedure of a trocar and external cannula assembly in accordance with some embodiments of the present invention;

FIGS. 4A-4B are a perspective view and a cross-sectional view of a surface of a distal portion of a trocar including a plurality of protrusions for increasing contact with the tissue in accordance with some embodiments of the present invention;

FIGS. 5A-5B are side views of a distal portion of a trocar including an expandable blade structure according to some embodiments of the present invention;

6A-6C are perspective views of a distal portion of an integrated trocar and outer cannula assembly, including a parallel anchor placement mechanism, in accordance with some embodiments of the present invention; and an enlarged view of the anchor;

7A-7B are side views of a distal portion of an integrated trocar and outer cannula assembly, including an arcuate anchor setting mechanism, in accordance with some embodiments of the present invention;

FIGS. 8A-8B are side and perspective views of a distal portion of an integrated trocar and outer cannula assembly, including a plurality of anchors, in accordance with some embodiments of the present invention;

FIGS. 9A-9C are several views of a trocar including a hub and an enlarged perspective and cross-sectional view of the system in accordance with some embodiments of the present invention;

FIG. 10 is a diagram of a ratchet-based applicator for setting anchors in accordance with some embodiments of the present invention;

11A-11B are a plurality of drawings of a spring element connected to spur elements for providing anchoring, and an enlarged view of a sliding element positioned over the spring, according to some embodiments of the present invention;

FIG. 12 is a drawing of an outer sleeve including anchors in accordance with some embodiments of the present invention;

FIG. 13 is a cross-sectional view of a head of the outer sleeve according to some embodiments of the present invention;

FIG. 14 is a diagram of an integrated trocar and outer cannula assembly in accordance with some embodiments of the present invention;

15A-15D are a set of diagrams showing an anchor set-up process in accordance with some embodiments of the present invention;

16A-16C are cross-sectional views showing actuation of a ratchet mechanism during retraction of the anchor applicator, in accordance with some embodiments of the present invention;

17A-17D are multiple test images (A-B) and cross-sectional views (C-D) of a distal portion of the device during actuation of the anchor applicator for setting multiple anchors according to some embodiments of the present invention;

FIG. 18 is a cross-sectional view of the device after anchors have been placed in tissue and before the trocar has been removed from the outer cannula in accordance with some embodiments of the present invention;

FIGS. 19A-19B are diagrams of some embodiments according to the invention

Showing a plurality of drawings (a) of the removal of the trocar from the outer cannula and a cross-sectional view (B) of the device during removal;

FIG. 20 is a flow chart of a method for using a wound closure device for deploying an anchor in accordance with some embodiments of the present invention;

21A-21H are a set of pictorial illustrations showing the operation of a wound closure device, in accordance with some embodiments of the present invention;

FIG. 22 illustrates an exemplary geometry of a distal portion of a trocar according to some embodiments of the present invention;

FIG. 23 illustrates an exemplary geometry of a surface disposed below a narrow portion of a trocar shaft in accordance with some embodiments of the present invention;

fig. 24A-24E are a set of drawings showing an operational procedure for an anchorless obturator for wound closure, in accordance with some embodiments of the present invention;

FIGS. 25A-25D are illustrations showing a distal portion of a trocar configured to provide a tissue plication effect (FIGS. 25A-25B), and anchoring puncture points in tissue obtained using the tissue plication effect (FIGS. 25C-25D), according to some embodiments of the invention;

FIGS. 26A-26I illustrate an anchor placement procedure with respect to a tissue plication effect and an exemplary configuration and operating mechanism of a trocar and outer cannula assembly, in accordance with some embodiments of the present invention;

27A-27B illustrate an exemplary handle and sliding element of a trocar according to some embodiments of the present invention;

28A-28I are various anchor designs in accordance with some embodiments of the present invention;

FIGS. 29A-29F illustrate a dovetail coupling between the outer cannula and the plurality of anchors (A-C) and an exemplary alignment configuration between a cannula needle and an outer cannula (D-F) in accordance with some embodiments of the present invention;

FIGS. 30A-30C illustrate a proximally facing cutting element of a trocar according to some embodiments of the present invention;

FIGS. 31A-31E illustrate an exemplary anchor placement procedure in which a proximally facing cutting element interacts with an anchor to pierce the tissue, according to some embodiments of the present invention;

FIGS. 32A-32D illustrate an anchoring spur element configured for placement of an anchor at a distance from the trocar shaft, in accordance with some embodiments of the present invention;

33A-33E illustrate a trocar including a set of rotatable wings configured to extend radially outward relative to the trocar shaft in accordance with some embodiments of the present invention;

FIGS. 34A-34E illustrate a trocar including an axially extending and compressible structure, according to some embodiments of the present invention;

FIGS. 35A-35E are an isometric and cross-sectional view, respectively, of an outer sleeve including a plurality of anchors and an exemplary configuration (C-E) of an outer sleeve including a plurality of suture spools, in accordance with some embodiments of the present invention;

FIGS. 36A-36B are photographs of an in vivo experiment conducted in a pig experimental model using a trocar and external cannula assembly, in accordance with some embodiments of the present invention;

FIGS. 37A-37F are photographs of another in vivo experiment conducted in a pig experimental model using a trocar and external cannula assembly, in accordance with some embodiments of the present invention; and

fig. 38A-38C are exemplary configurations of a trocar housed within an external cannula where the trocar shaft does not include a narrowing, according to some embodiments of the present invention.

Detailed Description

Some embodiments of the present invention relate to an integrated trocar and wound closure device including a trocar and an external cannula assembly. Some embodiments of the present invention relate to a wound closure device including an obturator (obturator) selectively positionable within an outer cannula.

A broad aspect of some embodiments of the invention involves providing anchors and/or sutures in tissue, such as into the fascia tissue of an abdominal wall, for closing a wound.

A broad aspect of some embodiments of the invention relates to a trocar shaft including a tang proximate a distal end of the trocar. In some embodiments, the narrow portion is positioned in the fascia layer when the trocar is inserted in the abdominal wall. In some embodiments, the narrow portion is sufficiently narrow to allow fascia tissue to recoil around it. Optionally, one or more recesses are formed along the shaft at the narrow portion, which may be at least partially filled with fascia tissue. In some embodiments, the tissue is positively urged to fill the depression defined by the narrow lock.

In some embodiments, the cross-sectional area of the narrowed portion is less than a shaft portion disposed above and/or below the narrowed portion, e.g., 30% less, 50% less, 70% less, or intermediate values, higher or lower percentages. As described herein, a cross-sectional area may refer to a total area, for example if the shaft includes a plurality of holes or other lumens.

In some embodiments, the circumference of the narrow portion is smaller than the circumference of the shaft portion arranged above and/or below the narrow portion. Optionally, the circumference of the narrow portion is small enough to allow fascia to enter one or more of the voids defined by the narrow portion. In some embodiments, the outer circumferential shape of the narrow portion, for example the outer circumferential shape, comprises a circumference shorter than a circumference of an outer circumferential shape of the shaft portion arranged above and/or below the narrow portion.

In some embodiments, the narrow portion is defined by one or more recesses. Optionally, the one or more recesses are circumferentially disposed along a wall of the shaft, forming recesses (recesses) along at least a portion of the shaft, such as on an oppositely facing wall of the shaft. In some embodiments, a depression starts at a particular distance from a longitudinal axis of the center of the shaft, such as a distance of 0.5 mm, 1 mm, 1.5 mm, 3 mm, 5 mm, or any intermediate, greater, or lesser distance. In some embodiments, a depth of the depression in a radial direction (i.e., toward a longitudinal axis of the shaft) is deep enough to accommodate at least a portion of the fascial tissue that springs back around the shaft, e.g., having a depth of 1 mm, 2 mm, 3 mm, 4 mm, or any lesser, intermediate, or greater depth. In some embodiments, the geometry of the recess is configured to accommodate entry of a relatively flat or straight ribbed membrane into the recess. In some embodiments, a recess is sized to fill an effective diameter of the shaft, such as a diameter of the shaft portion disposed above and/or below the narrow portion. Alternatively, the recess may be sized to fill an effective profile configuration of the shaft, for example if the shaft is not cylindrical.

In some embodiments, the narrow portion is sufficiently narrow to cause the trocar to be stabilized at the abdominal wall by fascia.

In some embodiments, the surfaces defined by the narrow portion, such as the surfaces of the shaft above or below the narrow portion, provide perceptible feedback to the user. Optionally, the feedback is provided due to resistance of the surface against the fascia.

In some embodiments, the length of the narrow portion is long enough to allow fascia having a thickness, such as 0.5 mm, 1 mm, 3 mm, 5 mm, 1 cm, 2 cm, or an intermediate, greater, or lesser thickness, to at least partially enter one or more voids defined by the narrow portion. In some embodiments, the length of the narrow portion is in a range between 0.1 to 20 millimeters, 0.1 to 40 millimeters, such as in a range between 0.1 to 5 millimeters, 6 to 10 millimeters, 0.2 to 0.4 millimeters, 4 to 7 millimeters, 1 to 3 millimeters, or an intermediate, larger, or smaller range. In some embodiments, the narrow portion of the shaft is sufficiently long that an anchor delivered from a shaft portion above and/or below the narrow portion or from an external cannula is disposed at the fascia layer. Alternatively, the narrow portion defines a location for an anchoring arrangement by being positioned within a fascia tissue layer. Alternatively, by controlling the positioning of the trocar, the user can control the location of the anchor placement, e.g., to ensure that the anchor pierces or partially pierces the fascia. Optionally, the distance between the multiple anchors that are set, for example the distance between two oppositely set anchors, is controlled.

In some embodiments, for example if the shaft has a circular profile, the diameter of the narrow portion of the shaft is at least 50% less than the diameter of the shaft portions of the trocar disposed above and/or below the narrow portion. In some embodiments, a hole (e.g., a wound) is formed in the tissue that is sized such that the fascia springs back around the narrow portion, e.g., by cutting and optionally expanding the hole. Optionally, the holes are expanded when the wider portion of the shaft is inserted, e.g., portions above and/or below the narrow portion, and when the narrow portion is positioned at the fascia, the holes in the tissue spring back elastically, returning or partially returning to the original size holes. Optionally, recoil of the tissue stabilizes the trocar in place. Because the recoil of tissue is related to the elasticity of the tissue, there may be a large difference in the degree of recoil between patients, for example. Optionally, the narrow portion is sufficiently narrow that at least part of the rebound can occur even if the degree of recoil of the patient's tissue is relatively low. Additionally or alternatively, a proximal facing surface below the narrow portion engages tissue such that the trocar is stably maintained in position by the proximal facing surface being secured to the tissue even if recoil does not occur or occurs slightly.

In some embodiments, the narrow portion defines a plurality of shaft surfaces facing the narrow portion that resist removal of fascia tissue from the narrow portion. Optionally, by positioning the trocar such that the fascia surrounds the narrow portion, the user may be exposed to increased resistance by the multiple surfaces increasing against the fascia when pulling or pushing the trocar.

In some embodiments, the resistance is provided by a surface proximal to a face of the trocar shaft below the narrow portion. In some embodiments, the proximal-facing surface comprises a tissue-engaging geometry effective to reduce or prevent movement of tissue received within the depression, e.g., radially outward movement of tissue, away from the depression. In some embodiments, contact between the proximally facing shaft surface and the fascia abdomen-facing surface is enhanced by friction, e.g., the shaft surface is textured, presents a discontinuous or continuous pattern, e.g., presents a wavy surface pattern, or any other type of pattern suitable for enhancing friction.

In some embodiments, the proximally facing shaft surface is adapted to at least partially enter the fascia tissue, e.g., toward the fascia tissue via one or more protrusions. Optionally, the plurality of protrusions puncture the fascia layer, and may also puncture and/or traverse the peritoneum adjacent the fascia. In some embodiments, accidental withdrawal of the trocar from the abdomen is avoided due to the resistance caused by the proximally facing surface of the shaft being maintained against the fascial tissue. In some embodiments, the proximal facing surface of the shaft includes a relatively flat geometry, for example, to provide increased resistance when the trocar is pulled in a proximal direction. Alternatively, the proximal facing surface is angled, sloped, hemispherical, or otherwise shaped.

In some embodiments, the geometry of the trocar may indicate the current position of the trocar within tissue. For example, in some embodiments, a user, such as a surgeon, can perceive the current depth of insertion of the trocar by the resistance encountered as the wider shaft portions above and below the narrow portion are pushed through the wound. This may provide an advantage in that the trocar insertion may be performed blindly (e.g., in cases where a surgeon cannot directly visually identify the layers of tissue, and/or use visualization devices).

In some embodiments, the shaft of the trocar includes a distal end portion with a narrow portion rearward thereof. Optionally, the change in articulation or point (point) between the distal portion and the narrow portion defines a surface configured to abut the fascia. Optionally, an element configured to block movement of the trocar in a deeper abdominal direction is behind the narrow portion in a proximal direction. Optionally, the blocking element is an enlarged or wider portion of the shaft. Optionally, the blocking element provides a user with a perceptible indication of the current position of the trocar, e.g., relative to the fascia.

An aspect of some embodiments relates to a trocar and external cannula assembly that includes a plurality of anchoring spur elements for providing anchoring. In some embodiments, an anchoring spur element is an element sized and/or dimensioned and/or positioned in a configuration suitable for engaging an anchor, advancing the anchor toward tissue, and/or into tissue. In some embodiments, the anchoring spur elements are manually and/or automatically retractable, such as by using a spring assembly to retract the spur elements once the anchors are positioned in fascial tissue, such as beneath the fascia layer. In some embodiments, the plurality of anchoring spur elements are configured to be parallel to a longitudinal axis of the trocar shaft. Alternatively, the plurality of anchor barbed elements are curved around the trocar shaft to provide a plurality of anchors at an angle relative to a longitudinal axis of the trocar shaft, optionally increasing the distance between the provided anchors. It is noted that in some embodiments, the anchoring spur element does not necessarily "spur" the anchor toward the tissue, but merely engages the anchor and/or propels it.

In some embodiments, the trocar is used with multiple external cannulae for closing multiple wounds, such as by inserting a single trocar at a time into different external cannulae located at the abdominal portal, and providing multiple anchors to close the wounds at the various portals.

An aspect of some embodiments relates to a trocar and external cannula assembly configured to position a plurality of anchors at a distance from one another that temporarily bring a plurality of puncture points in tissue into proximity with one another by forming a tissue fold. In some embodiments, the tissue plication effect provides for advancing multiple anchors substantially parallel to the trocar shaft, but disposing multiple anchors at a distance from the trocar shaft and/or at a distance from each other.

In some embodiments, the tissue is crimped into a substantially upside down U-shape, for example by the plurality of anchors. Optionally, the tissue is pierced at the bases of the upside down U-shape, for example by the anchors.

In some embodiments, tissue is crimped between the narrow portion of the trocar and an anchor and/or between the narrow portion of the trocar and an anchor piercing element. Optionally, prior to piercing, anchoring advancement in the distal direction pushes the tissue against the narrow portion to form a tissue fold. Alternatively, tissue folds are formed symmetrically on opposite sides of the trocar shaft tube by a plurality of relatively anchored advancements. In some embodiments, at least a portion of the trocar shaft is disposed in the center of the upside down U-shape, potentially preventing an anchor from piercing opposite sides of the fold.

Additionally or alternatively to crimping tissue between the anchoring and/or anchoring stab element and the narrow portion, a proximal shaft portion of the trocar may include one or more extensions at least partially aligned with the narrow portion, allowing tissue to be crimped between the shaft extension and the narrow portion.

An aspect of some embodiments relates to a spring-driven trocar external cannula assembly in which an anchoring arrangement is unobstructed by the spring. Potential advantages of advancing the anchor into tissue without encountering resistance from the spring may include providing more feel and/or control to the user, such as the clinician operating the trocar, that the resistance felt by the user is only that of the tissue, not that of the combination of the tissue and the spring.

In some embodiments, the spring is positioned to provide a "snap-back" mechanism that automatically retracts the plurality of anchoring barbed elements in a proximal direction, leaving the set anchors in the tissue.

An aspect of some embodiments relates to a trocar and outer cannula assembly that includes a maximum diameter (e.g., a diameter of the outer cannula surrounding the trocar shaft), such as less than 30 millimeters, 20 millimeters, 40 millimeters, or intermediate, larger, or smaller diameters. In some embodiments, the plurality of components of the device are connected to one another in a configuration that maintains all components within the limits of maximum diameter. In some embodiments, components of the device are configured to fit one within the other, e.g., a sliding element of the trocar is at least partially received within a lumen of a handle of the trocar. In another example, the outer sleeve includes one or more recesses shaped and/or sized to receive at least a portion of an anchor. Optionally, the recess defines a dovetail-like coupling between the anchor and the outer sleeve.

An aspect of some embodiments relates to a trocar including one or more proximally facing elements configured to interact with the anchor to assist the anchor in penetrating the tissue. In some embodiments, the proximal-facing element contacts tissue from a direction substantially opposite the anchoring. In some embodiments, the proximal-facing element includes a cutting edge and/or a tip, such as adapted to cut tissue as the anchor is advanced past the edge of the proximal-facing element. In some embodiments, as the anchor is advanced past the cutting edge, tissue secured between the cutting element and the anchor is cut in a scissor-like manner. Additionally or alternatively, a cutting tip of the element is configured to pierce tissue. Additionally or alternatively, a cutting tip of the element is configured to pierce a hole in tissue.

An aspect of some embodiments relates to a trocar and outer cannula assembly in which the outer cannula includes a plurality of anchors and/or sutures and the trocar includes a mechanism for engaging the plurality of anchors to position them in tissue. In some embodiments, the connection between the anchors and the outer cannula provides for insertion of the trocar into the cannula, e.g., in a "ready to use" configuration of the assembly, without causing undesirable distal advancement of anchors (e.g., advancement of anchors before a distal end of the device has been advanced through fascia). In some embodiments, the anchors are fixed in position relative to the outer cannula by a dovetail coupling until engaged by a plurality of anchoring barb elements that extend laterally outward from the trocar shaft during operation to contact the plurality of anchors and advance them into tissue.

A potential advantage of the anchor advancement mechanism in separating the outer cannula from the plurality of anchors may include the ability to reuse a trocar with multiple outer cannulae (e.g., by introducing the trocar into a different cannula at a time). This may be particularly advantageous in procedures where multiple ports are established in the abdomen and where multiple external cannulas are positioned in the multiple ports to allow passage of a laparoscope. Another potential advantage of the trocar including an integrated anchoring propulsion mechanism may include the outer cannula having a simple and cost effective construction, such as relative to an outer cannula, wherein at least a portion of the anchoring propulsion mechanism is integrated into the cannula itself. Another potential advantage of the trocar including an integrated anchor advancement mechanism configured to engage anchors and/or sutures associated with an external cannula may include a set including a variety of sizes (e.g., overall diameter, length) that do not exceed the size of a standard trocar and cannula set, except that the trocar and cannula set according to the present invention already includes the anchor and/or suture placement mechanism integrated into the set. Optionally, with all of the components of the deployment mechanism, such as the anchoring barbed elements, the anchors, the sliding elements that actuate advancement, and/or other elements being within the confines of the assembly (e.g., these components do not project radially outward from the cannula), the assembly has a smooth rounded contour around its circumference, e.g., effective to reduce tearing of tissue during penetration and to enable insertion of the assembly through a small wound.

A potential advantage of providing anchors and/or sutures using a trocar and/or trocar and outer cannula assembly as described herein may include providing anchors and/or sutures at a predetermined, limited depth in tissue. Another potential advantage may include providing multiple anchors and/or multiple sutures when the trocar is held in a stable position in the fascia tissue that surrounds the narrow portion, thereby reducing the risk of placing multiple anchors in undesirable positions relative to the device. Another potential advantage may include continuous control of the anchors and/or sutures by movement of a handle that is effective to sequentially advance the plurality of anchor barbed elements toward tissue. Another potential advantage of a setting mechanism such as described herein may include a mechanism that is based on linear or axial movement of multiple components, potentially simplifying user manipulation.

The term "trocar" (trocar), as referred to in some embodiments of the present invention, may refer to a surgical instrument adapted for insertion through the abdominal wall. In some embodiments, the instrument includes a sharpened distal tip, for example, for cutting through tissue and/or enlarging a wound. Alternatively, the instrument comprises a blunt end. Optionally, the apparatus includes a sharp end of a mask. In some embodiments, the instrument is insertable into a cannula. In some embodiments, the instrument is configured to engage a plurality of anchors and/or a plurality of sutures contained within the outer cannula.

The term "trocar and outer cannula assembly" as referred to in some embodiments of the present invention may designate a trocar located within an outer cannula. In some embodiments, the trocar and outer cannula assembly includes an integrated anchor placement mechanism. It should be noted that the term "assembly" may refer to one or both components of the assembly.

The term "obturator" as referred to in some embodiments of the present invention may refer to a surgical instrument adapted to be inserted through the abdominal wall for providing wound closure. Optionally, the instrument is inserted through an existing wound. In some embodiments, the instrument comprises a plurality of anchors and/or a plurality of sutures for placement in the tissue. In some embodiments, the instrument is inserted through an external cannula. Optionally, in various embodiments, the obturator itself includes a plurality of anchors and/or a plurality of sutures, and the outer sleeve does not include anchors and/or a plurality of sutures. In some embodiments, the instrument includes a blunt end.

The term "fascial layer" as referred to in some embodiments of the present invention may refer to one or more of the tissues of the fascia, the peritoneal tissue adjacent the fascia (peritoneum tissue), the fat layer adjacent the fascia, the fat layer between the peritoneum and fascia, and/or any other combination of abdominal tissues.

Before explaining at least one detailed embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Before explaining at least one detailed embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or illustrated by the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Before explaining at least one detailed embodiment of the invention in detail, it is to be understood that any relevant description of a trocar as described herein may also apply to a closure device as described herein and vice versa.

Summary of a distal portion of a trocar:

referring now to the drawings, FIG. 1 is a drawing of a distal portion of a trocar according to some embodiments of the present invention;

in some embodiments, the trocar includes a shaft 101. In some embodiments, shaft 101 includes at least a portion 103 that is narrower than portions defined above and/or below the narrow portion, such as portions 105 and 107. In some embodiments, the narrow portion 103 has a cross-sectional area that is less than the cross-sectional area of the shaft portions 105 and/or 107, such as 30% less, 50% less, 60% less, 70% less, or an intermediate, greater, or lesser percentage.

In some embodiments, shaft 101 is cylindrical. Optionally, narrow portion 103 has a diameter that is less than the diameter of the shaft portions defined by the narrow portion, such as portion 105 and portion 107.

Additionally or alternatively, in some embodiments, the shaft 101 comprises one or more recesses forming the narrow portion. Optionally, the recess is sized to receive fascia tissue. In some embodiments, the recess is defined circumferentially around the shaft. Alternatively, the recess is defined along a portion of the shaft, for example comprising 180 degrees, 270 degrees, or an intermediate, larger or smaller portion around the shaft. For example two recesses may be arranged along the oppositely facing walls of the shaft.

In some embodiments, a depression starts at a particular distance from a longitudinal axis AA' along the shaft center, such as a distance of 0.5 mm, 1 mm, 1.5 mm, 3 mm, or intermediate values, or longer or shorter distances. In some embodiments, a depth of the depression in a radial direction (i.e., toward a longitudinal axis of the shaft) is deep enough to accommodate at least a portion of the fascial tissue that springs back around the shaft, e.g., having a depth of 1 millimeter, 2 millimeters, 3 millimeters, 5 meters, or any lesser, intermediate, or greater depth. Optionally, a depth of the depression is determined and a portion of the shaft is reduced to allow the fascia to recoil around its circumference, but leave a sufficient distance from axis AA' to the beginning of the depression such that the resulting narrowing maintains sufficient rigidity, e.g., to provide proximal to distal translation force (transforming force) of the trocar.

In some embodiments, the geometry of the recess is configured to accommodate entry of a relatively flat or straight fascia into the recess. In some embodiments, the narrow portion is adjacent to the distal tip of the trocar 109. For example, a distance between the proximal facing surface 113 of the shaft and the distal tip 109, as defined by the narrow portion, ranges between 5 and 50 mm, for example 15 mm, 30 mm, 45 mm.

In some embodiments, the walls of the shaft portion 105 above the narrowed portion are sloped, for example as shown at 121, to form a tapered portion. Optionally, the plurality of walls are inclined at an angle, e.g., 20 to 80 degrees, such as 30 degrees, 60 degrees, 70 degrees, relative to a longitudinal axis of the trocar shaft. The angled walls may assist in insertion of the trocar into the abdominal wall.

In some embodiments, distal tip 109 is tapered. In some embodiments, distal tip 109 is a sharp tip configured to pierce a wound through the abdominal wall. Alternatively, the tip 109 is a blunt tip that may be inserted through an existing wound or port in the abdominal wall. In some embodiments, the size of the aperture of the wound is according to a diameter of shaft 101, e.g., a diameter similar to the diameter of shaft portions 105 and/or 107. Alternatively, an initial incision is enlarged by the trocar shaft, so the size of the aperture is dependent on the cross-section of the trocar shaft. In some embodiments, the wound aperture comprises a diameter of at least 3 millimeters, such as 4 millimeters, 5 millimeters, 6 millimeters, 8 millimeters, or an intermediate, larger or smaller diameter. Alternatively, the outline of the holes is not circular, for example, elliptical, rectangular or other shapes. Alternatively, the aperture comprises an arbitrarily shaped profile.

In some embodiments, at least a portion of the trocar is inserted through the abdominal wall, for example, through the skin 117 and/or through the fat layer 119 and/or through the fascia tissue layer 111.

In some embodiments, the proximally facing surface 113 of shaft portion 107 includes at least one protuberance 115, and the proximally facing surface 113 abuts fascia tissue, such as an interior aspect of fascia layer 111, upon insertion of the trocar.

In some embodiments, the diameter D of narrow portion 103 is, for example, less than a diameter D1 of shaft portion 105. In some embodiments, the diameter D of narrow portion 103 is, for example, less than a diameter D2 of shaft portion 107. Optionally, the diameter D is less than the diameter D1 and/or the diameter D2, such as 50%, 60%, 70%, 80%, and/or intermediate values, greater or lesser percentages. The diameter D1 may be determined based on the diameter of an outer cannula through which the trocar is inserted and may range between 12 and 20 millimeters. In some embodiments, the diameter d ranges, for example, between 2 to 5 millimeters, such as 3 millimeters, 4 millimeters. In some embodiments, diameter D1 is equal to diameter D2. Alternatively, diameter D2 is smaller than diameter D1, e.g., 10%, 20%, or 40% smaller.

In some embodiments, the diameter d is small enough to allow at least a portion of the tissue surrounding portion 103 to recoil around the trocar shaft when the trocar is inserted into the abdominal wall. One potential advantage includes utilizing the natural elastic properties of tissue to maintain the trocar in place and optionally for placement of anchors in the fascia layer.

In some embodiments, the length L of the narrow portion 103 ranges, for example, from 0.1 to 30 millimeters, such as 2 millimeters, 5 millimeters, 7 millimeters, 15 millimeters, 25 millimeters, or any intermediate value, or a longer or shorter length. Various trocars may include a variety of different length narrow portions. Alternatively, a trocar having a particular narrow portion length may be selected according to various parameters appropriate to the needs of the patient, such as the size of the aperture in the tissue, the thickness of the muscle layer, and/or the elasticity of the fascia layer. Alternatively, one or more of the parameters described herein may be correlated with the age of the patient receiving the treatment.

In some embodiments, a user operating the device, such as a surgeon, may encounter resistance caused by pulling and/or pushing the wider shaft portion 105 and/or 107 through the wound as the portion 105 and/or 107 is pushed through and/or withdrawn from the wound.

In some embodiments, an insertion depth of the trocar is defined by positioning the narrow portion 103 so that it is surrounded by the fascia layer. Optionally, the depth of insertion of the trocar is determined by a depth at which the plurality of anchors are further disposed. Alternatively, the depth of the plurality of anchors to be set is determined according to their range of movement. In some embodiments, the plurality of anchors are disposed at a depth that does not result in potential visceral damage to the closed fascial wound. In some embodiments, the anchor is disposed at a depth no greater than the depth of the tip 109. Alternatively, the anchor is disposed at a depth beyond the tip 109 along the distal square line.

During trocar insertion, the trocar geometry provides perceptible feedback, allowing the user to infer the current position (e.g., current depth) of the trocar in tissue at several stages during insertion. The user perceives less resistance, for example, when the narrow portion is pushed through a hole formed by the previous portion 107, the portion 107 having a larger diameter than the portion 103. If the trocar is pushed further into the tissue, the wider portion 105 may again increase the resistance perceived by the user, indicating to the user that the narrow portion 103 is fully inserted through the fascia 111 when the portion 105 reaches the hole of the fascia 111. In another example, to complete the positioning of the trocar, the user may pull back the trocar slightly until encountering resistance from the surface 113 against the interior of the fascia 111.

In some embodiments, a tension of up to 3N, up to 10N, up to 40N, or any intermediate value may be applied without causing portion 107 to pass posteriorly through fascia 111. Optionally, undesired withdrawal of the trocar from the tissue is avoided.

A geometry that provides positioning feedback that is perceptible to the user may provide an advantage in a situation where the trocar insertion and positioning may be performed blindly. Another potential advantage may include controlling the positioning of the trocar, such as the depth of insertion, even when the patient has a relatively thick layer of fat 119 between the skin 117 and fascia 111.

In some embodiments, a geometry of surface 113 is configured to increase resistance to removal and/or movement of the trocar relative to the fascia layer. In some embodiments, the surface 113 is textured for increased friction, for example with a wavy surface pattern, or other surface pattern. In some embodiments, surface 113 is configured to be secured to the fascia by including one or more protrusions. In some embodiments, the plurality of protrusions 115 are circumferentially configured. In some embodiments, the plurality of protrusions 115 are positioned on only a portion of the surface 113, such as the plurality of protrusions 115 are positioned on opposing portions of the surface 113, the plurality of protrusions cover a quarter, a third, or a half of the circular annular surface 113, the plurality of protrusions are positioned on two symmetrical quarters of the surface, and/or other protrusion configurations.

In some embodiments, at least a portion of the trocar shaft 101 is rigid, for example, to transmit pushing forces and/or transmitting pulling forces applied by a user to a proximal end of the shaft. Additionally or alternatively, the shaft 101 includes one or more flexible portions.

An exemplary method for inserting a trocar and external cannula assembly into an abdominal wall:

FIG. 2 is a flow chart of a method for inserting a trocar and wound closure device into a tissue to provide anchoring in accordance with some embodiments of the present invention;

in some embodiments, an assembly comprising the trocar and the outer cannula is pre-assembled, such as by inserting the trocar into the outer cannula and advancing the trocar to a "ready to use position" (200). Optionally, in a "ready to use" position includes a position in which the trocar is axially aligned with the cannula, so as to be adapted to dispose an anchor, such as a configuration in which a multi-anchor barbed element, such as described further herein, is positioned directly over (or, in some embodiments, even further protruding into a proximal portion of) a plurality of anchors, so as to allow the plurality of anchors to be disposed in tissue.

In some embodiments, a distal portion of the trocar is inserted into the abdomen (201). Optionally, the distal tip of the trocar forms a port in the abdominal wall, for example by including a blade. Alternatively, the distal portion of the trocar and/or outer cannula is inserted through an existing port or incision.

In some embodiments, the trocar is advanced (e.g., relative to the outer cannula) until the narrow portion of the trocar shaft has passed completely through the fascia tissue layer (203). Alternatively, when the wider and/or widened portion of the trocar shaft reaches the wound at fascia, the increased resistance felt by the user indicates that the narrow portion has been fully inserted.

In some embodiments, the trocar is pulled back slightly in an upright direction relative to the abdomen (205). Optionally, a proximal facing surface of a wider portion of the shaft defined by the narrow portion is lifted to rest against an interior face of the abdominal facing fascia. Optionally, the increased resistance created when the surface is pulled back against tissue indicates to the user that the trocar is positioned in a suitable location (e.g., depth), such as for placement of an anchor. In some embodiments, a plurality of anchors are disposed in a fascia tissue layer (207). Optionally, this positioning of the trocar ensures that the plurality of anchors are disposed at the fascia layer, e.g., rather than at the fat layer. Alternatively, this positioning of the trocar ensures the depth of the trocar providing an anchoring arrangement, for example a depth of the trocar tip relative to the skin, wherein the positions of the plurality of anchors are defined irrespective of the thickness of the fat layer between the fascia and the skin, or in general irrespective of any distance between the fascia and the skin, which may for example range between 0 and 100 mm.

The surface of the trocar shaft defined below the narrow portion seats the trocar in a predetermined position relative to the fascia, even when treating the abdominal wall of various thicknesses and/or anatomical structures. In some embodiments, the plurality of suture anchors pass flat to the trocar shaft. Alternatively, the plurality of anchors are delivered at an angle relative to the trocar shaft. In some embodiments, the distance between the plurality of anchors provided is equal to the diameter of the trocar shaft. Alternatively, the distance between the anchors provided is greater than the diameter of the trocar shaft, for example if the anchors are delivered at an angle relative to the trocar shaft. Alternatively, in some embodiments, the distance between the anchors provided is less than the diameter of the trocar shaft.

In some embodiments, once the plurality of anchors are deployed, the trocar is advanced distally such that the narrow portion is positioned within the abdominal cavity while the outer sleeve is surrounded by fascia tissue (208).

In some embodiments, the trocar is selectively removable from the outer cannula once the plurality of anchors are deployed (209). Optionally, a plurality of anchors are provided to assist in positioning the outer sleeve at a particular location relative to the tissue. Optionally, the plurality of anchors are provided to stabilize the sleeve. After removal of the trocar, the outer cannula may be left within the tissue to provide a port (210) for insertion of a laparoscope or any other instrument used during the procedure.

In some embodiments, the outer sleeve is removed from the tissue (211), for example at the end of the procedure. Optionally, the plurality of sutures attached to the plurality of anchors are tied to a layer of fascial tissue to close a wound.

In some embodiments, insertion of the trocar and outer cannula assembly is according to a common insertion method known as the "Hasson's technique", which involves dissecting through the abdomen until the fascia is identified, incising the fascia into the peritoneal cavity, and positioning at least two sutures in the wound on both sides of the fascia to close it.

In some embodiments, a narrow portion of the assembly is defined relative to the outer sleeve of the trocar, e.g., the trocar may not include a narrow portion (e.g., formed as a uniform cylindrical shaft) and the outer sleeve may be positioned relative to the trocar to define a narrow portion therebetween.

FIGS. 3A-3K are a set of diagrams showing an operational procedure of a trocar and external cannula assembly in accordance with some embodiments of the present invention;

in some embodiments, the assembly includes a trocar 301 and an outer cannula 303 (only a distal portion of the trocar is shown in this figure).

In some embodiments, such as described in fig. 3A and 3B, the user pushes the trocar through the abdominal wall by grasping the handle 305, such as through multiple layers of skin 307, fat layers 309, and/or fascia tissue 311. Alternatively, the trocar is pushed through a pre-formed incision in the skin, such as by a surgeon using a scalpel. In some embodiments, the user rotates the trocar about the trocar's longitudinal axis during insertion to move in a helical thread. Rotating the trocar may assist in advancing it through a tissue layer.

In some embodiments, the assembly is pushed until a distal end of the outer sleeve 315 passes through the fascia 311, e.g., protrudes to some extent below the fascia 311, e.g., at a distance of 10 to 80 millimeters below the fascia. In some embodiments, the assembly is pushed through fascia 311 only to the narrow portion of the trocar shaft. Alternatively, the extent to which the assembly and/or one or both components are inserted (e.g., trocar and/or cannula) into the fascia layer can be achieved by visual feedback provided by the narrow portion 317 and/or the surface below the narrow portion. Additionally or alternatively, the extent of insertion of the assembly into the fascia layer may be achieved by visual insertion.

In some embodiments, for example, positioning the assembly for placement of an anchor, the user pulls the assembly slightly in a proximal direction (away from the abdomen), as shown, for example, in fig. 3C and 3D. Optionally, the assembly is pulled until the proximally facing surface 319 of the trocar shaft portion 301 is maintained against the fascia 311. Alternatively, if surface 319 includes a plurality of protrusions (not shown in the figures), the pulling motion may cause the plurality of protrusions to slightly penetrate fascia 311 to improve contact between surface 319 and fascia 311.

In some embodiments, the user may confirm the current depth of the trocar within the tissue, for example by increasing the pulling force, such that the portion of fascia 311 (labeled 321) abutting surface 319 is stretched in a proximal direction. Optionally, the tissue 321 naturally springs back around the narrow portion 317. Alternatively, if the surface 319 is textured, the tissue 321 exhibiting and/or containing a plurality of protrusions (not shown in the figures) is maintained at the narrow portion even when this increased pulling force is applied. Optionally, the user perceives the increased resistance caused by the stretched tissue portion 321 and stops the pulling. Optionally, tissue 321 supports the narrow portion 317, thereby stabilizing the assembly in place.

In some embodiments, the assembly is configured to provide a plurality of anchors in tissue. In some embodiments, a plurality of anchors 323 are positioned along the distal portion of the outer sleeve 315, as will be explained in further detail. To begin setting the anchor, in some embodiments, such as shown in fig. 3E, the user lifts the upper cover 325 of the anchor applicator 327, pulling the anchor applicator 327 until it reaches a position where it is adapted for pushing the plurality of anchor barbed elements 331 downward. Pushing the plurality of anchors 323 toward the tissue, such as shown in fig. 3F, the user pushes the upper cover 325 back down in the direction of the abdomen while grasping the assembly and pulling proximally away from the abdomen. Optionally, fascia 311 is slightly stretched against surface 319. The plurality of anchors 323 are released beneath the fascia 311, for example at a depth of about 2 mm, 5 mm, 15 mm, 25 mm relative to the fascia 3111 to 30 mm. In some embodiments, the anchored ends do not extend beyond a distal end of the trocar during placement of the anchor. Alternatively, by limiting the depth of the multiple anchors provided, damage to the internal organs of the abdomen is prevented.

In some embodiments, the plurality of anchors 323 includes a plurality of sutures 329, for example, sutures threaded through holes in the anchors. Optionally, once the plurality of anchors 323 are released, the plurality of sutures 329 are free to extend away from the outer sleeve.

In some embodiments, such as shown in fig. 3G, a plurality of anchoring stab elements 331 return upwardly to the housing of the trocar. Alternatively, the plurality of anchoring spur elements are automatically pulled back, for example by using a spring mechanism, as will be further described.

In some embodiments, the user then pushes the assembly down in the abdominal direction (distal direction), e.g., as depicted in fig. 3H, e.g., to position a distal end of outer sleeve 315 beneath the fascia layer, optionally also piercing through the peritoneum. Alternatively, the user pushes the assembly until the outer sleeve 315 is fully inserted into the tissue along its length.

In some embodiments, such as shown in fig. 3I, the user withdraws the trocar from within the outer cannula 315. Optionally, the plurality of anchors 323 are disposed entirely within fascia 311. In some embodiments, the proximal ends of the plurality of sutures 329 remain attached to the proximal end of the outer sleeve, e.g., to the proximal end of the sleeve. Alternatively, the proximal ends of the plurality of sutures 329 hang freely. In some embodiments, the exterior of the plurality of sutures 329 extends to the cannula. Alternatively, a plurality of sutures 329 extend within the cannula.

In some embodiments, a plurality of anchors 323 are provided to assist in stabilizing the cannula in place, for example by using sutures extending between the proximal end of the cannula and the anchors provided in the tissue. In some embodiments, a port including an external cannula 315 is used to deliver a tool to the abdomen, such as a laparoscope. Optionally, the cannula 315 remains in the tissue until the procedure is complete.

In some embodiments, the outer sleeve is removed from the tissue, as shown, for example, in fig. 3J. Alternatively, if the proximal ends of the plurality of sutures 329 are attached to the sleeve at the time of removal, the user is used to separate the suture ends from the sleeve, such as by pulling on the suture ends to separate them from the sutures, or by cutting the suture ends. The plurality of anchors 323 that are disposed remain in the tissue. In this regard, in some embodiments, a user grasps and ties together a plurality of sutures 329 to close a wound 331 in the fascia 311.

In some embodiments, multiple anchors, e.g., 2, 3, 4, 6 or any intermediate or higher number, are disposed in the tissue. In some embodiments, a single anchor comprises more than one attached suture, such as 2, 3, 4 or a higher number of sutures.

In some embodiments, at least a portion of the shaft of the trocar 301 is hollow and sized for the passage of a tool therethrough. Optionally, the assembly is configured for insertion into the tissue over a guide wire that passes within the assembly, for example, within the lumen of the shaft of the trocar.

In some embodiments, the trocar may be used separately from the outer cannula. In some embodiments, the trocar may be inserted through any type of cannula. Such as any previously known in the art for use in laparoscopic surgical procedures. In some embodiments, a plurality of anchors and/or a plurality of sutures are fixedly attached to the trocar and not to the outer cannula.

In some embodiments, a single trocar may be used with multiple outer cannulae, such as when multiple ports are established in tissue. An exemplary procedure includes inserting a trocar into an outer cannula that has been previously positioned at a port, locking the trocar in the access cannula in a configuration that allows for placement of an anchor, such as by positioning an anchor applicator over a plurality of anchor barbed elements, placing a plurality of anchors from the outer cannula into the tissue, withdrawing the trocar, and repeating the procedure at a second port that includes a different outer cannula.

Alternatively, in some embodiments, the first cannula is assembled to the trocar, for example as described above.

Various embodiments of a distal portion of a trocar:

fig. 4A-4B are a perspective view and a cross-sectional view of a surface of a distal portion of a trocar including a plurality of protrusions for increasing contact with the tissue in accordance with some embodiments of the present invention.

In some embodiments, a proximal facing surface 401 of the trocar defined by the narrow portion 403 of the trocar shaft includes one or more protrusions 405. Optionally, during positioning of the cannula, such as during a slight pull back for positioning the trocar, the plurality of protuberances 405 prick the fascia layer facing the abdomen and optionally anchor to tissue to enhance contact between the surface 401 and the fascia. Optionally, a plurality of protrusions 405 assist in stabilizing the trocar.

In some embodiments, the plurality of protrusions 405 are shaped as a plurality of teeth, for example, having a triangular profile, a tapered profile, or other profile. In some embodiments, a protrusion includes a tapered end facing the fascia layer. Alternatively, the tapered end faces in the direction of surface 401. In some embodiments, the plurality of protrusions 405 are distributed circumferentially, such as along 10%, 30%, 60%, 80%, 100% or any intermediate, higher or lower percentage of the circumference of the surface 401. In some embodiments, the plurality of protrusions 405 are distributed on different portions of the surface 401, such as around the base of the narrow portion 403, on half of the surface 401, on a quarter of the surface 401, or on other portions of the surface. In some embodiments, the plurality of protrusions 405 cover at least 10%, at least 40%, at least 60%, at least 75%, or an intermediate, greater, or lesser percentage of the surface 401.

Additionally or alternatively, surface 401 is textured, such as wavy and/or bumpy (bump), for increasing friction between the shaft surface and the fascia.

In some embodiments, surface 401 is non-planar, e.g., has a tapered profile.

In some embodiments, distal tip 407 includes a recess 11. In some embodiments, a blade (e.g., made of plastic or metal) is positioned within the recess. In some embodiments, the blade is an integral part of the distal tip.

In some embodiments, the blade is configured to advance through the abdominal wall layer, e.g., to expand the wound radially outward, minimizing tissue tearing. Alternatively, a plastic blade is preferred for such wound dilation.

In some embodiments, such as a trocar suitable for use during a "Hasson technology" procedure, the tip 407 is not suitable for cutting tissue. In such a procedure, a surgeon may cut the skin using a scalpel or any other cutting device. In some embodiments, by having a smooth and/or blunt distal tip, a trocar may be used for the "harsen technique," e.g., without any sharp edges, which may prevent the risk of damaging abdominal tissue or nearby organs.

In some embodiments, the blade is sufficiently sharp for cutting through tissue. Optionally, the sheet is made of metal. In some embodiments, the shaft portion 409 includes more than one recess 411 in which multiple cutting blades can be positioned. In some embodiments, the trocar includes a mechanism, such as a spring biasing mechanism, for preventing the cutting blade from protruding from the recess unless a force is applied, such as during insertion of the trocar. Optionally, the safety mechanism is designed to lock at least a portion of distal tip 407 against the blade, e.g., one or more blades are prevented from protruding further from distal tip 407 after they protrude from the tip.

In some embodiments, the shaft portion 409 and/or 413 (above the narrow portion 403) includes one or more recesses 415 along the shaft. In some embodiments, the recess 415 extends longitudinally along the portions 409 and 413 with a space or pitch in the narrow portion 403.

In some embodiments, the recess 415 is sized to receive an anchoring and/or an anchoring barbed element. Optionally, a plurality of anchoring spur elements and/or a plurality of anchors are located between the inner wall of the cannula and the outer wall of the trocar when the trocar is positioned within the outer cannula. In some embodiments, the recess 415 has a cylindrical concave surface, for example, for receiving an anchoring barb element shaped as a round post.

In some embodiments, a distal end 417 of the depression 415 is located above the distal end of the trocar, such as 5 mm, 2 mm, 6 mm or intermediate or longer or shorter distances above the distal end of the trocar. Optionally, this configuration defines a depth at which the plurality of anchors are disposed relative to the fascia. Optionally, the plurality of anchors are disposed at a depth equal to the length L measured between the surface 401 and the distal end of the trocar. Alternatively, the anchors are provided at a depth shorter than the length L, for example 10%, 30%, 40%, 50% shorter or an intermediate value, a higher or lower percentage shorter. Alternatively, the anchors are provided at a depth longer than the length L, for example 10%, 30%, 40%, 50% longer or an intermediate value, a higher or lower percentage longer. Optionally, providing anchoring at a depth greater than length L is accomplished by pushing the plurality of anchoring spur elements to a degree beyond the distal end of the trocar.

In some embodiments, a surface of shaft portion 413 opposite surface 401 has a tapered profile, such as shown in fig. 4B, for example, to smoothly insert the trocar through the tissue surrounding narrowed portion 403. Optionally, the conical profile causes an increase in resistance as the trocar is inserted into tissue to provide a user with a perceptible indication as to the location of the trocar, for example, to indicate that the narrow portion is in the fascia layer.

FIGS. 5A-5B are side views of a distal portion of a trocar including an expandable blade structure according to some embodiments of the present invention.

In some embodiments, a surface of the trocar shaft defined below the narrow portion 501 includes an expandable structure, such as a blade structure 503. In some embodiments, the structure 503 includes a plurality of blades 505. In some embodiments surface embodiments, blades 505 are disposed circumferentially around the surface of the shaft.

In some embodiments, a blade includes two or more segments 507. Optionally, the plurality of intersegment joints 507 are flexible to allow bending relative to other segments. Alternatively, a blade comprises a single segment. In some embodiments, the single segment 507 of the blade has a thin, planar geometry, e.g., shaped as a rectangle.

In some embodiments, the blade structure is suitable for two modes of operation: a closed mode, shown in FIG. 5A; and an expanded mode, shown in FIG. 5B.

In some embodiments, in the closed mode, the plurality of vanes are in an upright position. Optionally, in this mode, the plurality of blades do not extend beyond the circumference of the trocar. Optionally, the plurality of blades are in a closed mode during insertion of the trocar into tissue to allow smooth insertion of the trocar.

In some embodiments, the plurality of blades expand upon a slight pull back of the trocar. In some embodiments, in the expanded position, the blades are curved to form an angle between the plurality of segments 507, such as 30 degrees, 50 degrees, 80 degrees, 90 degrees, or intermediate values, greater or lesser angles. In some embodiments, in the expanded position, at least a portion of a blade 505 extends beyond the periphery of the trocar. Optionally, the curvature between the plurality of leaflets defines a relatively sharp edge 509 that can pierce the fascia.

In some embodiments, the plurality of leaflets transition automatically from a closed mode to an open mode, such as when the trocar is withdrawn, the plurality of leaflets bend as they are forced against the surface of the fascia. Alternatively, in some embodiments, the user mechanically initiates the expansion, for example by using a lever connected to the plurality of blades, which may be pushed and/or pulled by the user to expand the plurality of blades.

In some embodiments, the blade structure 503 prevents unintended withdrawal of the trocar from tissue by abutting against the fascia and creating a resistance in a direction opposite to the pulling direction.

In some embodiments, the blade structure 403 is converted from an open mode to a closed mode, e.g., for fully retracting the trocar from tissue, by a spring placed within the distal tip of the trocar.

In some embodiments, the distal tip of the trocar 507 is blunt, e.g., as a bulbous tip.

It should be noted, however, that in some embodiments according to the invention, at least a portion of the features of the plurality of structures described herein, such as the expandable structure and/or blunt end, and the narrow portion of the shaft, may be adapted for use with a narrow portion of a wound closure device (such as an obturator as described herein).

FIGS. 6A-6C are perspective views of a trocar with a distal portion of an outer cannula including a parallel anchor setting mechanism in accordance with some embodiments of the present invention; and an enlarged view of the anchor;

in some embodiments, one or more anchors 601 are positioned at a distal portion of the outer sleeve 603. In some embodiments, the sleeve 603 includes a recess 605 in which the anchor is positioned. Optionally, the anchor is positioned in the recess such that it must not extend beyond the circumference of the sleeve. In some embodiments, the anchored inner surface contacts an inner surface of the trocar shaft, such as an inwardly concave (concave) surface of the shaft.

In some embodiments, an anchor barbed element 607 is used to advance anchor 601 into tissue. Alternatively, in an insertion position, such as shown in fig. 6A, the anchoring spur element is positioned between the trocar shaft and the outer cannula 601 and is not externally visible.

In some embodiments, the anchoring spur element 607 is pushed forward during the anchoring setting. Optionally, the distal end of the element 607 is pushed into the anchoring lumen 609. In some embodiments, the anchoring spur element 607 is shaped as a cylindrical rod. Optionally, the inner cavity 609 is dimensioned to receive the element 607, for example also having a cylindrical profile.

In some embodiments, one or more anchors 601 are disposed in tissue. Optionally, the plurality of anchors are disposed parallel to a longitudinal axis of the trocar. Alternatively,

the plurality of anchors are disposed at a leveling distance of 3 to 10 millimeters from the trocar distal end, such as 4 millimeters, 6 millimeters, 8 millimeters from the trocar distal end. Optionally, the distance 611 between the anchored ends is provided in a range between 6 and 20 mm, such as 8 mm, 12 mm and 16 mm.

In some embodiments, an anchor 601, such as shown in FIG. 6C, includes a tapered end for piercing tissue. In some embodiments, anchor 601 includes one, two, or more holes 615 for a suture to pass through. Optionally, passing the suture through the hole prevents undesirable knotting of the suture.

In some embodiments, anchor 601 includes a blunt end, such as a rounded end. Optionally, lumen 609 extends between opposite ends of the anchor. In some embodiments, the lumen 609 is sized to accommodate the anchoring spur element 607 in such a way that the distal end of the element 607 passes beyond the distal end of the anchoring. Optionally, for example in the depicted configuration, the distal end of the piercing element 607 is tapered for piercing tissue prior to anchoring 601.

In some embodiments, additionally or alternatively to passing within the anchored lumen, a tapered spur element is configured to slide along an anchor. In some embodiments, the tapered stab element is configured to surround a tubular to be anchored. Optionally, a distal end of the tube pierces tissue prior to being positioned in the anchoring of the lumen of the tube.

In some embodiments, anchor 601 is made of a hard material, such as titanium or plastic. In some embodiments, anchor 601 is made of a material suitable to be absorbed in tissue over time, such as Glycolide (PGA), so that it does not need to be removed from the tissue once the plurality of sutures have been tied and the wound has been closed. In some embodiments, the plurality of sutures are made of a material suitable to be dissolved in tissue over time, such as Glycolide (PGA).

FIGS. 7A-7B are side views of a trocar and a distal portion of an outer cannula including an arcuate anchor setting mechanism in accordance with some embodiments of the present invention;

FIG. 7B illustrates an embodiment in which the anchor 701 is disposed at an angle to the trocar shaft 703. in some embodiments, an anchor barbed element 705 is wrapped around the shaft 703 between the shaft and the outer sleeve 707. optionally, the shaft 703 and/or the sleeve 707 include an arcuate concave depression for guiding the barbed element 705 in a wrapped fashion.

In some embodiments, the arcuate anchor setting mechanism increases the distance between the set anchors.

FIGS. 8A-8B are side and perspective views of a distal portion of a trocar and outer cannula including a plurality of anchors according to some embodiments of the present invention.

In some embodiments, the assembly includes a plurality of anchors 801, such as 2, 4, 6, 7, 8, 9, 12 anchors, or any intermediate or greater number of anchors. In some embodiments, each anchor is pushed by a respective anchor spur element 803. Alternatively, an anchoring spur element is configured to push more than one anchor, such as by having a bifurcated end.

In some embodiments, multiple anchors are provided together, such as with knots of multiple sutures to close the wound. Alternatively, a portion of the anchors (e.g., 2 anchors) are disposed at a first port location and a portion of the anchors are disposed at a second port location, and so on.

Description of various Components of an Assembly of a trocar and an external cannula

Fig. 9A-9C are several views of a trocar including a sleeve, and an enlarged perspective and cross-sectional view of the system, in accordance with some embodiments of the present invention.

In some embodiments, a trocar 901 includes a sleeve 903. In some embodiments, the sleeve 903 is passed over the trocar shaft, e.g., covering a narrow portion of the shaft and/or a plurality of shaft portions above and below the narrow portion.

In some embodiments, sleeve 903 allows trocar 901 to be inserted and/or withdrawn from an outer cannula

(not shown in this figure), for example by changing the position of the sleeve along the trocar at different stages during the insertion and retrogradation procedure.

In some embodiments, a sleeve (sleeve)903 is configured to spatially orient the trocar 901 at a location within the outer cannula. In some embodiments, sleeve 903 includes a plurality of extensions 905 extending outwardly from the trocar for aligning the trocar relative to the outer cannula.

In some embodiments, sleeve 903 includes a plurality of inwardly extending extensions 907 for aligning a distal anchoring spur element during insertion of the trocar into the outer cannula.

In some embodiments, the sleeve 903 is adapted to seal the space between the trocar 901 and the outer cannula, e.g., to prevent air and/or gas from escaping from the abdomen, such as carbon dioxide, which is commonly used during laparoscopic procedures.

In some embodiments, sleeve 903 includes a tooth 909. In some embodiments, the tooth 909 includes a set of protrusions, such as a protrusion facing inwardly toward the trocar shaft and/or a protrusion facing outwardly toward the cannula. Optionally, a projection is used to insert and/or retract the trocar, such as by being pressed inwardly, to allow movement of the trocar relative to the outer cannula. A second, oppositely facing projection can be used to grip the trocar during trocar retraction, so that the trocar "collects" the sleeve from its upper position between the trocar and the cannula during removal of the trocar from the outer cannula.

Fig. 10 is a diagram of a ratcheted-base applicator for setting anchors in accordance with some embodiments of the present invention.

In some embodiments, an anchor applicator 1001 is positioned within a trocar. In some embodiments, the anchor applier comprises a handle 1003, a shaft 1005, and a distal portion comprising a set of a plurality of teeth 1007 and/or a plurality of teeth 1009.

In some embodiments, the handle 1003 can be pulled in a proximal direction from the surgical trocar and then pushed back downward to actuate the anchored arrangement.

In some embodiments, shaft 1005 includes a toothed edge 1011. Optionally, edge 1011, along with a control rod (not shown) disposed on the interior surface of the trocar shaft, includes a ratchet assembly, as further described herein.

In some embodiments, the upper set of teeth 1007, configured to lock to a sliding element (not shown), sequentially pushes the anchoring stab elements forward when the handle 1003 is depressed.

In some embodiments, the lower set of teeth 1009 provides a sliding release mechanism for retracting the piercing elements into the trocar. Optionally, a plurality of tines 1009 are pushed back into the lumen of the trocar shaft, e.g., moved closer together. Optionally, this movement further causes the plurality of teeth 1007 to move closer to each other, thereby releasing the locking of the sliding element.

Fig. 11A-11B are diagrams of a spring element connected to spur elements for providing anchoring, and an enlarged view of a sliding element positioned over the spring, according to some embodiments of the present invention.

In some embodiments, a spring 1101 is positioned within the lumen of the trocar shaft. In some embodiments, a plurality of anchor barbed elements 1103 are positioned along the spring, for example directly over the anchors (not shown in the figures). In some embodiments, a sliding element 1105 is attached to the spring at a proximal end, as shown in the enlarged view of FIG. 11B.

In some embodiments, teeth of an anchoring applicator, such as teeth 1007 as described above, are urged against a surface 1105 of the sliding element 1103, such as when the anchoring applicator is urged downward to actuate anchoring settings the sliding element 1103 in turn urges the anchoring elements 1103 attached thereto further downward, urging the anchors toward the tissue.

In some embodiments, once the anchor applicator has been pushed to the extent and the anchors have been set, teeth (e.g., teeth 1009 as described above) are pushed into the lumen of the trocar shaft and the compressed spring 1101 automatically returns to its original position, causing the anchor stab elements 1103 to rise back up the lumen of the trocar shaft.

Fig. 12 is a drawing of an outer sleeve including anchors in accordance with some embodiments of the present invention.

In some embodiments, a head at a proximal end of the cannula includes an insertion aperture 1201 through which the trocar and/or other surgical instrument is introduced into the trocar. In some embodiments, the head includes a valve 1203, for example, to regulate the admission of CO 2.

In some embodiments, at least a portion of the sleeve includes a plurality of anti-slip tabs 1205.

In some embodiments, one or more anchors 1207 are positioned at a distal portion of the outer sleeve, e.g., as described herein.

Fig. 13 is a cross-sectional view of a head of the outer sleeve according to some embodiments of the present invention.

In some embodiments, when the trocar surrounded by the sleeve is inserted into the outer cannula, the circumference of the portion of the trocar covered by the sleeve is larger than the circumference of the lumen 1301 of the cannula. Optionally, upon reaching surface 1303, an outward face of the sleeve embodiment as shown above catches the protrusion 1305 of the cannula, thereby holding the sleeve in an upper position sealing the space between the trocar and the cannula. Alternatively, the trocar and outer sleeve are provided by other means than a sleeve, such as an annular band (e.g., O-ring) that may be used at one or more locations along the trocar shaft.

Fig. 14 is a diagram of an integrated trocar and outer cannula assembly in accordance with some embodiments of the present invention.

In some embodiments, a proximal portion of the assembly comprises the trocar handle 1401. In some embodiments, a retractable and pushable handle of the anchor applicator 1403 located in the lumen of the trocar shaft is disposed in the handle 1401. In some embodiments, any of the handles include a non-slip surface, such as surface 1411, for example, to facilitate gripping of the handle.

In some embodiments, the trocar is inserted into the outer cannula such that handles 1401 and 1403 are positioned over a crown (cap)1405 of the cannula.

In some embodiments, a distal end of the trocar, for example, includes a narrow portion 1407 and a tip 1409 projecting outwardly from the distal opening of the outer sleeve.

In some embodiments, the anchoring applicator is cannulated, e.g., the assembly is inserted over a guidewire. Additionally or alternatively, the trocar handle surrounding the anchoring applicator is cannulated, e.g., leading to a lumen of the trocar shaft that is unoccupied.

An exemplary anchor setup procedure:

in the following description, fig. 16-18 describe stages of an exemplary anchor setup procedure, corresponding to a set of multiple figures as shown in fig. 15.

Fig. 16A-16C correspond to fig. 15A in cross-sectional views showing actuation of a ratchet mechanism during retraction of the anchor applicator, in accordance with some embodiments of the present invention.

In some embodiments, the anchor setup procedure is initiated and the user pulls back on the handle 1603 of an anchor applicator 1601. During pull back, the applicator is free to lift upward, disengaging from the ratchet assembly as the stem (lever)1605 is maintained away from the toothed edge 1607 of the anchor applicator. Once the applicator 1601 is lifted, it reaches a position (shown in fig. 16C) where its upper set of teeth 1609 lock against a surface of the sliding element 1611.

Optionally, in the cocked stage (cocked), the sliding element 1611 is positioned above the plurality of anchoring barbed elements, which sequentially deliver the plurality of anchors to the tissue in a position suitable for advancing the anchoring barbed elements one.

Fig. 17A-17D are multiple test images (a-B) and cross-sectional views (C-D) of a distal portion of the device during actuation of the anchor applicator for setting multiple anchors according to some embodiments of the invention.

In some embodiments, such as shown in fig. 17A and 17C, a ready-to-fire (cocked) stage of the assembly includes the anchor applicator 1601 positioned such that the tooth 1609 is locked onto the surface of the slide element 1611 and the distal edge of the slide element is disposed over the anchor barbed element 1703, the anchor barbed element 1703 being positioned along the side of the spring 1701.

In some embodiments, when the user pushes on the handle of the applicator 1601, as shown in fig. 15B, the toothed edge 1607 of the applicator snaps against the stem (lever)1605, allowing the applicator to move in a single direction and limiting movement in an opposite direction. In some embodiments, lifting of the applicator 1601 is prevented by a ratchet assembly (ratchet assembly), for example, to prevent pull back of the applicator during anchor set up, providing additional safety.

In some embodiments, user (e.g., a physician) feedback is provided to indicate to the physician the current mode of operation of the device, e.g., tactile feedback (e.g., resistance by pulling and/or pushing the handle), audible feedback (e.g., a snapping sound of members as they move relative to each other), visual feedback (e.g., indicating the degree of advancement by a scale marked on the handle, for example.) in one example, as the applicator is advanced forward, a snapping sound that produces a lever (lever)1605 against the tooth rim 1607 indicates to a user that anchors 1705 are currently being advanced forward.

As shown, for example, in fig. 17B and 17D, applicator 1601 has been advanced to a minimum limit, such as a plurality of anchors 1705 piercing tissue, such as fascia layers. In some embodiments, a lower set of the plurality of teeth 1707 are pushed into the lumen of the trocar shaft, thereby reducing a diameter such that the sliding element 1611 can freely move back up through the trocar shaft (positioned outside the sliding element).

In some embodiments, the plurality of anchoring spur elements 1703 are automatically pushed back into the lumen of the trocar shaft, for example by utilizing the spring force of the compressed spring 1701. In some embodiments, the sliding element 1611 is pushed back upward by the spring 1701, lifting the plurality of anchoring stab elements 1705. Optionally, the distal ends 1703 of the plurality of spike elements are separated from the plurality of anchors 1705 now disposed in the tissue.

Alternatively, in some embodiments, a user may mechanically actuate the return of the plurality of anchoring spike elements, such as by rotating the applicator 50, 70, or 90 degrees, to release the ratchet mechanism, and/or simply pull back the applicator.

Fig. 18 corresponds to fig. 15C, a cross-sectional view of the assembly once anchors have been placed in tissue and the sliding element 1611 has been retracted. According to some embodiments of the invention, the assembly is shown prior to removal of the trocar from the outer cannula.

In some embodiments, the configuration of the assembly includes a home position with the sliding element 1611 in its upper portion, prior to removal of the trocar from the outer cannula, such that the shaft (lever)1605 (not shown in this figure) is away from the toothed edge 1607. In some embodiments, the lower set of teeth 1707 are pressed into the trocar lumen.

Fig. 19A-19B are a number of drawings (a) showing removal of the trocar from the outer cannula and a cross-sectional view (B) of the device during removal, in accordance with some embodiments of the present invention.

In some embodiments, the trocar 1901 is withdrawn from the outer cannula 1903. In some embodiments, a protrusion 1905, such as depicted in fig. 9, is secured to a sleeve during retraction on the trocar when the trocar is lifted. Alternatively, the fixation of the protrusion 1905 is only possible when the narrow portion 1907 of the trocar reaches the sleeve. Optionally, the removed trocar 1901 includes the sleeve disposed back to the original position and around the narrow portion 1907, and portions of the trocar shaft disposed above and/or below the narrow portion.

Fig. 20 is a flow chart of a method for using a wound closure device for setting an anchor according to some embodiments of the present invention.

In some embodiments, an obturator includes an elongated shaft, and a distal portion of the shaft includes a narrow portion having a diameter that is smaller than the diameter of portions of the shaft disposed above and below the narrow portion.

In some embodiments, a proximal facing surface of the shaft defined below the narrow portion is configured to rest against a surface of the fascia tissue layer facing the abdomen. In some embodiments, the surface of the shaft portion defined by the narrow portion comprises one or more protrusions. In some embodiments, the surface is physico-chemical. In some embodiments, the surface comprises an expandable structure.

In some embodiments, the obturator includes a blunt distal tip, such as a rounded tip.

In some embodiments, the obturator comprises one or more anchors positioned along a side of the obturator shaft. Optionally, the plurality of anchors are positioned in parallel recesses. Additionally or alternatively, the plurality of anchors are positioned in arcuate depressions. In some embodiments, the obturator includes a plurality of anchoring spur elements, e.g., disposed over the plurality of anchors. In some embodiments, the anchoring spur elements are positioned in recesses parallel to a long axis of the obturator. Alternatively, the plurality of anchoring spur elements are positioned in a plurality of recesses helically twisted around the obturator shaft.

In some embodiments, a plurality of sutures are passed through an anchor. Optionally, free ends of a plurality of sutures extend within the outer sleeve, such as a handle connected at a proximal end to the obturator.

In some embodiments, an end of the obturator is inserted into a port in the abdominal wall (2001). Optionally, the obturator is inserted through a sleeve, for example the sleeve previously lodged in tissue. Alternatively, the obturator is inserted directly into the tissue, for example, after a sleeve has been removed from the port, and the remaining wound is closed.

In some embodiments, the obturator is pushed until the narrow portion of the obturator shaft is fully inserted into the fascia tissue layer (2003). Alternatively, the user perceives that the narrow portion has been fully inserted by encountering the resistance created when the wider (or widened) portion over the narrow portion is advanced through the fascial incision.

In some embodiments, the user slightly pulls back the obturator until the proximal facing surface of the shaft disposed below the narrow portion remains against the fascia layer (2005). Optionally, a protuberance on the surface pierces into the fascia, enhancing contact between the obturator and the tissue. A potential advantage of the surface against fascial tissue includes preventing unintended removal of the obturator.

In some embodiments, a plurality of suture anchors are disposed in tissue, such as fascia (2007). In some embodiments, sutures are provided by lifting a crown (cap) at a proximal end of the obturator and pushing the crown (cap) downward to advance the anchor barbed elements, sequentially pushing anchors into tissue. Optionally, the obturator includes an anchor deployment mechanism, for example as described with reference to the trocar herein and/or with reference to the combination of a trocar and an outer cannula.

In some embodiments, the obturator is removed from the tissue (2009). Optionally, the outer sleeve is removed from the tissue. In some embodiments, multiple suture ends are tied to close the wound (2011).

Fig. 21A-21H are a set of diagrammatic views illustrating the operation of a wound closure device according to some embodiments of the present invention.

FIG. 21A shows a cannula 2101 positioned at an abdominal port. Alternatively, the cannula is used throughout laparoscopic surgery, e.g., for insertion through a laparoscope. Fig. 21B shows the obturator 2103 inserted through the cannula 2101. Fig. 21C shows the obturator 2103 positioned in tissue such that the narrow portion 2105 is surrounded by a fascia tissue layer 2107, optionally with the fascia tissue layer 2107 resiling around it. In some embodiments, an inflatable vane structure 2109 is positioned on the fascially facing surface of the obturator shaft, which is shown in its open position in this figure.

In some embodiments, the user pulls on a crown 2111 positioned at the proximal end of the obturator 2103 to initiate the anchoring arrangement. In some embodiments, as the crown 2111 is pushed back down, the plurality of anchor barbed elements 2113 (shown in this figure as a helical depression around the obturator shaft) are pushed toward the plurality of anchors 2115 to push the plurality of anchors into the tissue. Figure 21D shows a plurality of anchors 2115 disposed at fascia 2107, e.g., above fascia 2107, through fascia 2107, and/or directly below fascia 2107. Optionally, a plurality of suture ends 2117 extend within the cannula 2101.

In some embodiments, the plurality of anchoring barbed elements 2113 are retracted into the lumen of the obturator shaft, for example automatically with the aid of a spring. Fig. 21E shows the plurality of anchoring spur elements 2113 within the lumen of the obturator shaft, and the expandable paddle structure 2109 in its closed position, optionally in preparation for removal of the obturator from the tissue.

In fig. 21F, the obturator is pushed back slightly down to get deeper into the tissue. Optionally, closure of the expandable leaflet structure is ensured by slightly pushing the obturator deeper. Alternatively, the proximal ends of the plurality of sutures 2117 are separated from the proximal end of the obturator 2103 and/or cannula 2101 by slightly pushing the obturator deeper.

In some embodiments, such as shown in fig. 21G, the obturator 2103 is removed from the casing 2101. Optionally, a plurality of free ends of a plurality of sutures 2117 extend outwardly from insertion apertures 2119 of the cannula.

FIG. 21H shows the removal of the sleeve 2101. Alternatively, removal of the sleeve may pull on a plurality of sutures to enhance the fixation of a plurality of anchors 2115 to tissue, for example if the suture ends remain attached to the proximal end of the sleeve. Optionally, a plurality of sutures are tied together to close the wound after the sleeve is removed. Alternatively, the plurality of sutures are tied through the cannula to remove the cannula.

An exemplary geometry of a distal portion of a trocar:

FIG. 22 illustrates an exemplary geometry of a distal portion of a trocar according to some embodiments of the present invention. In some embodiments, the narrowed portion is formed at one or more recesses 2201 of trocar shaft 2203. Alternatively, a recess may comprise a rectangular profile, for example as shown in this figure. This figure shows two rectangular depressions opposite each other, forming between them the "walls (walls") of the shaft 2205, surrounded by fascial tissue entering the depressions.

In some embodiments, the depth of the depression in a radial direction is large enough to allow fascia tissue to enter at least partially into the depression, such as shown by bar 2211. The depth of the depression as referred to herein may also extend between a virtual continuation of a wider portion of the shaft (e.g., portion 2213 disposed below the narrow portion or portion 2215 disposed above the narrow portion) and a surface 2217 of the shaft at the location of the narrow portion. Optionally, the recess has a depth in the range of 0.1 to 5 mm, such as 1 mm, 2.5 mm, 3.5 mm, or any smaller, larger, or intermediate distance.

The width of the narrow portion (formed as "wall" 2205) may refer to the total distance of the opposing faces of wall 2205 from the longitudinal axis AA' of the shaft, e.g., surface 2217 and surface 2221. Optionally, distance 2223 measured between surface 2217 and axis AA' of the shaft ranges between 0.3 to 5 millimeters, such as 0.5 millimeters, 1 millimeter, 3 millimeters.

In some embodiments, the slit 2207 is configured proximate to the distal tip 2209 of the trocar. Optionally, the slit extends along a cross-section of the trocar, for example, through to the opposite side of the shaft. In some embodiments, the slot is configured to receive a blade. Optionally, the direction of the slit is aligned with the direction of the "wall" 2205. In some embodiments, the shaft portion 2215 includes a tapered surface 2219 facing the one or more depressions.

An exemplary geometry of a surface disposed below a narrow portion of a trocar shaft:

FIG. 23 illustrates an exemplary geometry of a surface disposed below a narrow portion of a trocar shaft in accordance with some embodiments of the present invention. In some embodiments, surface 2301 includes one or more lumens 2305. Optionally, during positioning of the trocar, for example when the trocar is pulled slightly upward in a proximal direction, at least a portion of the fascia layer is pushed slightly into one or more lumens, for example slightly into the trocar shaft. One potential advantage of the tissue being pushed at least partially into the lumen includes enhanced contact between surface 2301 and the fascia layers, for example to help stabilize the trocar during anchor placement. In some embodiments, lumen 2305 includes a portion of surface 2301, such as 20%, 40%, 70%, 85%, or an intermediate value, higher or lower percentage of surface 2301. The lumens may be shaped as sectors (sectors), rings (rings), small circular holes (small circular holes), or any other configuration. In some embodiments, at least a portion, such as a distal portion, of the trocar is formed by using a molding technique and the lumen is formed by using a mold having a desired lumen pattern.

An anchorless obturator for wound closure:

fig. 24A-24E are a set of drawings showing an operational procedure for an anchorless obturator for wound closure, in accordance with some embodiments of the present invention.

In some embodiments, the distal portion 2401 of a shaft 2402 of the obturator includes a narrow portion 2403 having a diameter that is smaller than the diameter of portions of the shaft disposed above and below the narrow portion, such as portion 2405 and portion 2407, respectively. In some embodiments, a proximal facing surface 2406 of the shaft portion 2407 defined by the narrow portion is adapted to abut a surface of the fascia 2409, e.g., including one or more protrusions 2411.

Various embodiments may include various cross-sections of the shafts, such as having an oval or any other configuration suitable for insertion into a wound 2423.

In some embodiments, the obturator includes one or more needle tips 2412. Optionally, the plurality of needle tips are positioned within and/or on the surface of the shaft portion 2407. For example, in some embodiments, the plurality of needle tips 2412 are attached to a forked structure (pitchfork shaped)2413 positioned within the shaft 2402. In some embodiments, the central portion 2415 of the structure 2413 extends longitudinally in the proximal direction, e.g., extends beyond the narrow portion 2403. Optionally, portion 2415 extends all the way through shaft 2402 to a proximal end of the obturator for manipulation by a user.

In some embodiments, the side portions 2417 of the structure 2413 extend within the shaft portion 2407. Optionally, a needle tip 2412 is removably attached to a proximal end of the portion 2417, e.g., the tip of the needle tip faces in the proximal direction.

In some embodiments, a needle tip 2412 is threaded with one or more sutures 2419. Optionally, a length of suture extends between the two needle points. In some embodiments, the suture 2419 is located within the shaft portion 2427. Optionally, suture 2419 is folded so that it can be compatibly wrapped within portion 2427. Additionally or alternatively, portion 2427 may comprise a groove for receiving the suture. The grooves may be disposed within the shaft portion 2427, outside a surface of the shaft 2427, or a combination thereof. In some embodiments, the suture 2419 may be located at a more proximal portion of the shaft, for example if portion 2427 includes a blade and/or a recess for receiving a blade.

In some embodiments, the suture 2419 is a single strand suture. Alternatively, suture 2419 is a double-stranded suture. Optionally, the suture 2419 forms a loop 2429 for engaging the needle tip 2412.

In some embodiments, the shaft portion 2405 includes one or more depressions 2421 for receiving a plurality of needle tips 2412 and/or a plurality of portions 2417, as will be further shown.

In some embodiments, such as shown in fig. 24A, the obturator is inserted into the abdominal wall and positioned such that fascial tissue 2409 surrounds the narrow portion 2403. Optionally, surface 2406 abuts a distally facing surface of fascia 2409, and the plurality of protuberances 2411 may penetrate the fascia to enhance contact.

In some embodiments, such as shown in fig. 24B, the prong (pitchfor)2413 is pulled in a proximal direction, causing the plurality of needle tips 2412 to pierce the fascia 2409 in the proximal direction. In some embodiments, the plurality of needle tips 2412 exit the fascia 2409 at the shaft portion 2405 and enter the depression 2421. The suture 2419 is pulled in a proximal direction through the fascia 2409 by the plurality of needle tips 2412. Optionally, the needle tip 2412 is configured for rotation about its longitudinal axis, for example during fascia puncture. One potential advantage of rotating the needle tip includes assisting the needle tip in piercing the fascia. Alternatively, rotation is achieved by wrapping the suture to the needle tip such that when the needle tip is advanced or passed through the fascia, and force (e.g., friction) is applied to a continuation of the suture at any location along the suture (e.g., by a clasp (claspp) or other suitable means for restraining a portion of the suture), the wrapping of the suture causes the needle tip to rotate as it is advanced.

In some embodiments, such as shown in fig. 24C, the forked structure 2413 is pushed in a distal direction, optionally returning to its original position in the shaft portion 2407.

The plurality of tips 2412 are maintained within the plurality of depressions 2421, such as by being grasped by a clasp (clasps), a pin, hook, or other suitable means for maintaining coupling between the tips and the walls of the depressions. In some embodiments, the recess 2421 comprises one or more notches (notch)2425, for example, for engaging the needle tip when the needle tip enters the recess. Optionally, the engagement between the recess and the needle tip is a frictional engagement.

In some embodiments, such as shown in fig. 24D, shaft portion 2405 is pushed through fascia 2409 to engage portion 2407. Optionally, at least a portion of plurality of side portions 2417 (e.g., proximal ends thereof) enter plurality of depressions 2421. Optionally, suture 2419 remains attached to the plurality of needle points 2412 (e.g., at the ends thereof) so that it passes through fascia 2409 a second time, this time in the distal direction, by pushing portions 2405 to engage portions 2407.

In some embodiments, the obturator is selectively pulled in a proximal direction in its "compact" configuration (with portion 2405 engaging portion 2407), removed from the abdomen. The ends of the plurality of sutures 2419 may be slid off of the plurality of needle points 2412 upon removal of the obturator and/or severed from the plurality of needle points and/or separated from the plurality of needle points by other suitable means of removing the plurality of suture couplings.

In some embodiments, such as shown in fig. 24E, suture 2419 maintains attachment fascia 2409. Optionally, the ends of the plurality of sutures 2409 (or alternatively, two or more sutures) extend from opposite sides of the wound 2423. In some embodiments, the plurality of ends are tied together to close the wound.

Potential advantages of deploying a suture with an anchorless obturator, such as described above, include: avoid

The arrangement of closure assistance elements (e.g., anchors and/or needle tips) remains within the tissue. For example, in an obturator described, a plurality of needle tips are removed with the obturator, leaving only sutures positioned at a location of the fascia.

Fig. 25A-25D are illustrations showing a distal portion of a trocar configured to provide a tissue plication effect (fig. 25A, 25B) and anchoring puncture points in tissue obtained using the tissue plication effect (fig. 25C, 25D), according to some embodiments of the invention. In some embodiments, the geometry of the distal portion of the trocar is adapted to create a tissue plication effect when puncturing the fascia. In the exemplary configuration shown herein, a narrow portion 2501 of the trocar, as shown in fig. 25A, includes a shaft portion 2503 formed with one or more depressions 2507, and a tubular portion 2509 extending proximally to portion 2503. It is also possible that the narrow portion is referred to only as a tubular portion 2509, while the shaft portion 2503 may be defined as the portion created by removing material from a shaft portion disposed directly below the narrow portion, including against the proximally facing surface of the fascia. In some embodiments, portion 2509 is not tubular, e.g., includes a rectangular, triangular, trapezoidal, and/or other cross-sectional profile.

In some embodiments, such as shown in fig. 25B, during advancement of the plurality of anchors 2511 to dispose them at the fascia tissue 2513, and prior to actual penetration of the tissue, the plurality of anchors push the fascia tissue 2513 in a distal direction, as indicated by the plurality of arrows 2517, forming a tissue fold 2519 between the anchor 2511 and the narrow portion 2501 of the shaft portion 2503.

In some embodiments, a proximal-facing surface 2521 of shaft portion 2503 optionally includes one or more protrusions 2535 against fascia 2513, thereby defining a force acting on tissue in a proximal direction that resists distally directed forces exerted on tissue by the plurality of anchors and/or by the plurality of anchor stab elements during advancement of the plurality of anchors. These resistances to tissue may result in the formation of wrinkles 2519.

In some embodiments, once the crimp 2519 is obtained, the multiple anchors are further advanced to pierce the curled tissue.

A potential advantage of forming a tissue fold prior to placement of the anchors in tissue may include increasing the distance between the anchors being placed, for example: when compared to providing multiple anchors in unfolded tissue. By utilizing the folds, the tissue portions pierced by the anchors are temporarily brought closer to each other, which anchors can be arranged at a greater distance from each other. Fig. 25C shows a plurality of puncture points 2523 brought into proximity with one another by tissue plication 2519. Optionally, a plurality of puncture points 2523 are located at the base of the upside down U-shape of the curled tissue. In some embodiments, the trocar is configured to maintain a plurality of puncture points 2523 separate from one another, such as by shaft portion 2503, to reduce the risk of an anchor piercing to opposite sides of the tissue fold.

In fig. 25D, the wrinkles are released. Alternatively, once the anchors pierce the tissue, the folds are released, thereby no longer applying a tensile force on the tissue in the distal direction, such that the plurality of piercing points 2523 are a greater distance 2525 from each other. Alternatively, the distance 2525 may range, for example, between 5 and 50 mm, such as 10 mm, 25 mm, 40 mm or intermediate straight, larger or smaller distances.

In some embodiments, the plurality of anchors 2511 are delivered into the tissue along a linear path. In some embodiments, by creating tissue folds, the effect of placing multiple anchors diagonally can be achieved without actually placing multiple anchors at an angle relative to the axis of the trocar. Alternatively, a plurality of anchors are disposed at an angle relative to the trocar axis. Alternatively, a tissue fold is created and anchors are disposed at an angle relative to the trocar axis, potentially increasing the distance 2525 between the disposed anchors to a greater distance.

In some embodiments, the size of the portion of tissue folded between the plurality of anchors 2511 and the shaft portion 2503 of the narrow portion 2501 is determined by the distance 2527 between a proximally facing surface 2521 of said shaft portion 2503 and a surface 2529 of the distal tip 2531 against the tissue.

Additionally or alternatively, in some embodiments, for anchoring, tissue fold 2519 is obtained by one or more extensions (not shown in the figures) of proximal shaft 2533, extending along at least a portion of its length in the direction of narrow portion 2501. Optionally, the extensions are substantially aligned with the narrow portions 2501. in some embodiments, tissue is crimped between multiple extensions of the proximal shaft 2533 and the shaft portion 2503 and/or the tubular portion 2509.

In some embodiments, increasing the distance between the plurality of configured anchors is achieved by other structures and/or methods, such as by clamping the tissue with a clamp or similar device.

In some embodiments, shaft portion 2503 includes a rectangular cross-sectional profile, for example as shown herein. Alternatively, the shaft portion 2503 includes a circular, square, and/or any other cross-sectional profile. Optionally, an area of the proximal facing surface 2521 of the shaft portion 2503 (e.g., without the plurality of protrusions 2523) is less than a surface of the surface 2529 of the distal tip 2531.

In some embodiments, surface 2529 of distal tip 2531 includes a surface structure adapted to increase contact with tissue, such as including one or more protrusions (not shown in this figure). Optionally, surface 2529 is textured, e.g., including bumps and/or corrugations.

FIGS. 26A-26I illustrate an anchor placement procedure with respect to a tissue plication effect and an exemplary configuration and operating mechanism of a trocar and outer cannula assembly, according to some embodiments of the present invention.

The following figures diagrammatically illustrate 2604 a trocar 2602 positioned within an outer cannula for placement of a plurality of suture anchors in the fascia.

In some embodiments, such as in fig. 26B, a distal portion 2601 of the trocar disposed distal to the narrow portion 2603 is advanced into fascia 2605. In some embodiments, a handle 2607 includes a spring 2609 housed in a lumen of the handle and pulled in a proximal direction to tension the spring 2609. When the handle is pulled in the proximal direction until a proximal set of the plurality of gripping teeth 2619 of the sliding member extend radially outward, and a sliding member 2611, which is locked into a position in which a distally facing surface in the wall of the handle contacts proximal ends of the plurality of gripping teeth 2619, is disposed within the lumen of the handle 2607 and connected to the distal end of the spring 2609, remains stationary. The plurality of anchor barbed elements 2613 are positioned in a position suitable for applying a force to the plurality of anchors to advance them distally.

In fig. 26C, the handle 2607 is pushed in a distal direction by pushing the slide member 2611 distally, initiating advancement of the plurality of anchors 2615 toward the tissue, thereby pushing the plurality of anchor barbed members 2613 in a distal direction by the slide member. During advancement of the plurality of anchors 2615, the fascia 2605 is stretched in a distal direction and a tissue fold 2617 is formed between the plurality of anchors 2615 and the narrow portion 2603, as shown, for example, in fig. 26D.

In some embodiments, once the tissue fold 2617 is created, the handle 2607 is pushed further downward to cause the plurality of anchors 2615 to pierce the fascia, such as shown in fig. 26E. A potential advantage of pushing the handle 2607 in the distal direction while the spring remains stationary (e.g., not stretched and/or compressed by the pushing of the handle) can include providing a more accurate feel and control of a user (e.g., a physician) operating the trocar because the resistance encountered by the user when pushing the anchors into tissue is only that of the tissue and not that of the combination of the tissue and the spring or other mechanical components of the trocar.

In some embodiments, as the anchors are pushed further distally, the gripping teeth 2619 of the sliding element 2611 are pushed radially inward, such as by a step or protrusion (protrus) disposed on an inner wall of the trocar shaft 2621. At this point, occurring between the configurations shown in fig. 26F and 26G, the sliding member 2611 can again conform to the interior of the lumen of the handle 2607, allowing the spring 2609 to spring back within the lumen of the handle to its original, unextended configuration. As the spring 2609 returns to the starting position, such as depicted in fig. 26G, the sliding member 2611 is spring-backed in a proximal direction, bringing the plurality of anchoring spike members 2613 together.

In some embodiments, after the "snapping point", the spring returns to its original length, as shown in fig. 26G, the tissue fold 2617 of the fascia 2605 is essentially released, such that a plurality of anchors 2615 comprising a plurality of sutures 2623 are disposed in the fascia at a distance from each other. At this stage, the trocar and outer cannula assembly can be further advanced distally, as shown, for example, in fig. 26H, to position the outer cannula within fascia 2605. In fig. 26I, after the trocar 2602 has been pulled in a proximal direction and disengaged from the outer cannula 2604, the cannula 2604 remains in the tissue, providing a port for inserting a number of tools, such as a laparoscope into the abdomen. In some embodiments, when the cannula 2604 is removed from the tissue, a plurality of sutures 2623 are tied together to close the wound in the fascia 2605.

In some embodiments, as with the exemplary structures described herein, a maximum diameter 2625 (fig. 26A) of the trocar and outer cannula assembly is in a range of, for example, 6 to 25 millimeters, such as 10 millimeters, 15 millimeters, 23 millimeters, or a median, larger or smaller diameter. In some embodiments, one or more members of the assembly are configured to fit within another so as to maintain a relatively small overall diameter, e.g., the sliding element as described above fits at least a portion within a lumen of the handle.

Fig. 27A-27B illustrate an exemplary handle and sliding element of a trocar according to some embodiments of the present invention.

In some embodiments, the handle 2701, as shown, for example, in FIG. 27A, includes a grip portion 2703 and a shaft 2705. In some embodiments, shaft 2705 is at least partially cannulated, including a lumen 2707 extending along at least a portion of the length of handle 2701, such as 30%, 50%, 75%, or an intermediate value, greater or lesser percentage, of the length of handle 2701. In some embodiments, the handle 2701 includes a surface 2709 that extends across the distal end of the handle 2701. Optionally, surface 2709 is shaped to engage a plurality of anchoring spur elements and pull them in a proximal direction when handle 2701 is pulled back. For example, where the "springback" (snap) described above does not occur and the plurality of anchoring barbed elements, when the handle is pulled back, the surface 2709 can engage the plurality of anchoring barbed elements and urge them in a proximal direction to provide additional safety in the case of the assembly (e.g., where the spring cannot return to its non-extended configuration).

In some embodiments, the sliding element 2711 as shown in fig. 27B is configured to conform inside the lumen 2707 of the handle 2701. In some embodiments, the sliding element 2711 includes a shaft 2712, a proximal set of a plurality of gripping tines 2713. Optionally, a plurality of teeth 2713 extend radially outward relative to the shaft 2712 and are configured to spring back toward the shaft when external forces are applied thereto, such as through the inner wall of the trocar shaft, the inner wall of the lumen 2707 of the handle 2701, and/or through a plurality of stepped projections configured along the path of movement of the sliding element 2711 within the trocar (not shown in this figure). In some embodiments, the sliding element 2711 includes a set of elements 2715 at a distal end configured to engage the proximal surface of a plurality of anchoring spike elements to advance them distally. Optionally, a plurality of elements 2715 project radially outward relative to shaft 2712.

In some embodiments, the position of the sliding element 2711 relative to the lumen 2707 of the handle 2701 is determined by the configuration of the plurality of proximal teeth 2713, such as when the plurality of teeth 2713 are pushed inwardly toward the shaft 2712, providing for the sliding element to enter the lumen 2707 and slide therein, and when the plurality of teeth 2713 extend outwardly, maintaining the sliding element 2711 in a distal position. In some embodiments, the plurality of elements 2715 are configured to engage a plurality of anchoring spike elements by advancing the sliding element 2711 to provide for distally advancing the plurality of anchoring spike elements.

A potential advantage of a trocar including a plurality of members sized and/or shaped to conform to one another (e.g., the shape and size of the sliding element 2711 to conform to the interior of the lumen 2707 of the handle 2701) may include a compact configuration of the plurality of members such that a trocar of relatively small diameter provides various anchoring arrangements and tissue piercing functions, as well as providing smooth axial movement of the plurality of members relative to one another.

Fig. 28A-28I are various anchor designs in accordance with some embodiments of the present invention.

In fig. 28A-28E, an exemplary hollow anchor 2801 is shown. In fig. 28F-28I, an exemplary self-piercing (self-piercing) anchor 2817 is shown.

In some embodiments, an anchor (e.g., hollow anchor 2801 and/or self-piercing anchor 2817) is formed by a lumen 2803 extending along a portion of the length of the anchor, such as shown in fig. 28G, or along the entire length of the anchor, such as shown in fig. 28B. In some embodiments, lumen 2803 is shaped and/or sized to receive an anchoring spike element 2807.

In some embodiments, such as shown in fig. 28B, the anchor spike element 2807 can be advanced through a distal opening 2809 of the anchor. Optionally, a distal portion 2811 of the anchor spike element 2807 includes a more proximal portion 2823 of smaller cross-sectional area than the spike element to advance through the anchor and potentially pierce tissue prior to the anchor. A potential advantage of a hollow anchor 2801 configured to receive an anchor spur element 2807 may include reducing the load applied to the anchor because at least a portion of the load is transferred to the anchor spur element 2807 located within it. Another potential advantage of a hollow anchor may include the ability to pierce tissue using a sharp anchoring barb element, optionally made of metal (e.g., rather than piercing tissue with the anchor itself). The anchoring spur element further guides the anchoring into the abdominal cavity.

In some embodiments, the anchor 2801 and/or the anchor 2817 include one or more internal channels 2821 for passage of the suture 2813, such as shown in fig. 28C and 28D and 28G-28I. In some embodiments, such as in hollow anchor 2801, an internal channel is formed within and/or along the inner wall of lumen 2803.

Optionally, suture 2813 is passed through the anchor prior to performing the procedure. Additionally or alternatively, suture 2813 passes through the anchor during the procedure.

In some embodiments, anchor 2801 and/or anchor 2817 includes a substantially flat surface 2815 configured to abut fascia tissue facing the abdomen, such as when the anchor is pulled in response to suture 2813 being pulled as well, such as during wound closure. In some embodiments, an anchor includes a sharp-pointed distal tip 2819 adapted to pierce tissue. Alternatively, the anchor comprises a blunt end. Optionally, a blunt end provides stretching of the tissue prior to actual penetration, potentially creating a tissue plication effect such as described herein.

Fig. 29A-29 x illustrate a dovetail coupling between the outer sleeve and the plurality of anchors according to some embodiments of the present invention.

In some embodiments, the coupling between anchor 2901 and outer sleeve 2903 (in which trocar 2911 is housed) is configured to maintain anchor 2901 in a fixed position relative to the outer sleeve as trocar 2911 moves within the sleeve, such as during advancement of the trocar within the sleeve, to achieve a "ready to use" configuration. In some embodiments, the location (e.g., axial and/or circumferential location) of the coupling between anchor 2901 and outer sleeve 2903 is determined to allow for during operation

A plurality of anchor barbed elements of the trocar engage the plurality of anchors while preventing undesired distal advancement of the plurality of anchors, such as during advancement of the trocar to a "ready to use" configuration. In some embodiments, such as shown in a cross-section of the trocar and outer cannula assembly along line a-a, tail 2905 of anchor 2901 includes a first width 2907 and a second, larger width 2909 at the outermost portion of anchor 2901. Optionally, width 2909 is at least 10%, 40%, 60%, or an intermediate, greater or lesser percentage greater than width 2907. The inner walls 2915 of the outer sleeves 2903 are each formed with a similarly shaped and sized recess 2917 adapted to receive the anchored tails 2905.

Likewise, in a distal cross-section of the trocar and outer cannula assembly along line B-B, the recess 2917 is contoured to match a distal portion of the anchor 2901, such as the portion through which a suture 2919 passes.

In some embodiments, a proximal portion of outer cannula 2903 (not shown in the figures) includes a geometry adapted to align trocar 2911 relative to outer cannula 2903. In one example, the proximal portion of the outer cannula includes one or more recesses and/or protrusions configured to engage the plurality of protrusions and/or recesses, respectively, of cannula needle 291.

Additionally or alternatively, a sleeve 2925 (shown in fig. 29D and enlarged in fig. 29E) is positioned between the outer sleeve and the trocar, for example as shown in fig. 29D-29F. Optionally, the proximal portion 2927 of the cannula 2903 shown in cross-section in fig. 29F includes a geometry adapted to align the sleeve relative to the cannula such that the trocar 2911 positioned within the sleeve is aligned by the sleeve in a selected alignment configuration relative to the cannula. In this example, the sleeve 2925 includes one or more elongated protrusions 2929 on an outer surface of the sleeve and an elongated protrusion (not shown) on an inner surface of the sleeve that can be received within a mating elongated recess 2931 of the trocar 2911. The proximal portion of proximal portion 2927 includes at least a plurality of mating recesses on an inner surface thereof for receiving the plurality of elongated protrusions of the sleeve, respectively. Notably, the geometry may include other shapes and/or contours of the plurality of protrusions and recesses disposed on the trocar, sleeve, and/or cannula.

Fig. 30A-30C are views of a proximally facing cutting element of a trocar according to some embodiments of the present invention.

In some embodiments, a distal portion 3001 of a trocar, such as that shown in fig. 30A, includes one or more proximally facing cutting elements 3003. In some embodiments, the cutting element 3003 comprises at least one cutting edge 3009 and/or a tip 3011 adapted for use in cutting and/or perforating and/or penetrating tissue.

In some embodiments, cutting element 3003 is positioned opposite distal tip 3005 of anchor 3007. In some embodiments, the cutting element remains stationary during operation, and the anchor 3007 is advanced distally until interacting with the cutting element 3009, which cuts and/or pierces tissue from a direction substantially opposite to the piercing direction of the anchor, i.e., a substantially distal to proximal direction. A potential advantage of contacting tissue to pierce from opposite sides may include creating a more precisely located wound. Another potential advantage may include anchoring faster punctures.

In some embodiments, the distal trocar portion 3001 includes a recess 3017 in which the anchor 3007 is received. In some embodiments, the cutting element 3003 is disposed within the recess 3017, e.g., extending from a distal end of the recess in a proximal direction toward the anchor. Optionally, cutting element 3003 is at least partially circular in profile and defines a volume within which at least a portion of the length of anchor 3007 is accommodated.

In some embodiments, the depth of the point of penetration of the tissue is determined by a relative distance 3015 between a proximal-facing surface 3013 of the distal portion 3001 against which the fascia rests and the cutting edge 3009 of the cutting element 3003.

The cross-section shown in fig. 30B shows the interface between the edge 3009 of the cutting member and the anchor 3007. Fig. 30C shows the anchored distal tip 3011 proximal to the cutting edge 3009.

In some embodiments, the interface between cutting edge 3009 and anchor 3007 creates a scissor-like effect, cutting tissue between the two as anchor 3007 slides against cutting edge 3009. Additionally or alternatively, a punch-type (punch-type), pin-hole-type (pin hole-type) wound may be formed by the interaction between the anchor 3007 and the edge 3009.

Alternatively, the wound is created only by the edge 3009. Alternatively, the wound is created only by the anchor 3007.

Alternatively, the element 3003 is not a cutting element and does not include a cutting edge. Optionally, element 3003 is positioned at least partially in the advancement path of anchor 3007 to interact with the anchor when the anchor is penetrating tissue. Optionally, at least a portion of member 3003 receives anchor 3007 therein.

One potential advantage of utilizing a proximally facing cutting element during piercing of tissue may include reducing the risk of damaging tissue, which may occur when a distally facing cutting element is used and inadvertently advanced into tissue.

Fig. 31A-31E illustrate an exemplary anchor placement procedure in which a proximally facing cutting element interacts with an anchor to pierce the tissue, according to some embodiments of the invention.

In some embodiments, such as shown in fig. 31A, a distal trocar portion 3101 is advanced into the fascia 3103 and positioned such that the fascia 3103 abuts against the proximal-facing shaft wall 3105. One or more proximally facing cutting elements 3113 are currently positioned in and/or below the fascia 3103, having a proximally facing cutting edge 3115 and/or tip.

At this stage, such as shown in fig. 31B, a plurality of anchors 3107 are advanced toward the fascia, optionally forming tissue folds 3109, e.g., as described herein. In some embodiments, tissue plications are created in the depression 3111 of the trocar portion 3101, and the tissue is crimped between the anchor 3107 and the walls of the depression 3111.

In some embodiments, as the plurality of anchors are further advanced distally, resulting in more tissue entering between the anchors and the depressions, the degree of tissue plication 3109 is increased, such as shown in fig. 31C.

In some embodiments, such as shown in fig. 31D, a plurality of anchors 3107 are advanced to contact and/or pass beyond the cutting edge 3115 of the cutting element 3113 to pierce the fascia 3103. In some embodiments, the plurality of anchors 3107 are advanced beyond the plurality of cutting elements 3113. Optionally, a plurality of anchors 3107 are advanced beyond the distal end of the trocar 3117. Alternatively, the plurality of anchors do not advance beyond the distal end of the trocar. Optionally, an anchor is at least partially received within the lumen of cutting element 3113.

In fig. 31E, fascia 3103 has returned to an essentially flat state, and the plurality of anchor spinous elements 3119 has been pulled away from the tissue in a proximal direction, leaving the plurality of anchors 3107 disposed in the tissue.

In some embodiments, for example, when the trocar is withdrawn from tissue, damage to the tissue may be caused to pass by moving the plurality of cutting elements 3113 in a proximal direction, while may be reduced or avoided by delivering the distal trocar portion 3101 through the outer sleeve (not shown in the figures), which acts as a barrier between the plurality of cutting elements and the tissue during withdrawal.

Notably, the tissue plication effect is not a requirement for the proximally facing cutting element to be operational and is simply presented as an additional option in this description that may or may not be achieved during use of the trocar assembly.

Fig. 32A-32D illustrate an anchoring spur element configured for placement of an anchor at a distance from the trocar shaft, in accordance with some embodiments of the present invention.

In some embodiments, where it is desirable to provide an anchor 3201 at a distance 3207 relative to the trocar shaft 3203, an anchor barbed element 3205 is urged at one or more locations along its length to create an angle relative to the longitudinal axis of the trocar 3209, thereby providing an anchor radially away from the trocar. Alternatively, as the anchoring barbed element is advanced distally to push the anchor, one or more members of the trocar push the anchoring barbed element away from axis 3209. During advancement, for example, the barbed element 3205 may be pushed sideways when encountering the shaft wall 3211. Additionally or alternatively, the barbed elements 3205 may be pushed sideways due to the resistance of the tissue.

Additionally or alternatively, an arcuate anchoring spur element is used, such as shown in FIG. 32B, optionally, spur element 3205 is formed with one or more curves, relative to a straight line 3213, as indicated by angles α and β, optionally, angle α and/or angle β range, such as between 5 and 20 degrees, such as 7 degrees, 10 degrees, 15 degrees, or intermediate values, greater or lesser values.

Fig. 32C and 32D illustrate an exemplary structure and mechanism provided for advancing the anchoring barbed element 3205 at an angle relative to the longitudinal axis 3209. Fig. 32C shows element 3205 prior to advancement, according to some embodiments of the invention. FIG. 32D shows element 3205 in an advanced position for placing multiple anchors in tissue. When referring to the path of advancement of the anchoring protruding piercing element, point a indicates an axially moveable position, geometrically defined by the sliding element 3221, which is moved distally in the trocar shaft. Point B indicates a static position defined between the trocar shaft and the outer sleeve 3225 through which the anchoring spur element is pushed. In some embodiments, points a and B are located along an axis 3209 that is parallel to the longitudinal axis of the trocar. As the arcuate piercing elements 3205 are advanced by the sliding elements, point A moves closer to point B and elements 3205 are urged to extend radially outward relative to axis 3209.

Fig. 33A-33E illustrate a trocar including a set of rotatable wings configured to extend radially outward relative to the trocar shaft in accordance with some embodiments of the present invention. In some embodiments, a trocar includes one or more elements configured to define and/or limit a plurality of puncture regions for anchoring into tissue. In some embodiments, a trocar includes one or more elements adapted for increased surface area against which the fascia is stretched, potentially assisting the plurality of anchors in penetrating through the stretched tissue.

FIGS. 33A-33E illustrate a set of wings configured to perform one or both of the above-described functions. Fig. 33A shows a set of wings 3301 that are rotatably attached to a shaft portion 3303 in a closed configuration. In some embodiments, the wings are configured distal to the narrow portion 3305 such that when anchors (not shown) are advanced distally they are directed through a frame 3311 defined by the wings when in an open configuration.

Fig. 33B shows a cross-section of the shaft portion 3303 with the wing assembled thereon. In some embodiments, a wing 3301 includes a substantially U-shape such that when rotated to an open configuration, such as shown in fig. 33C and in cross-section in fig. 33D, the wing 3301 optionally defines a frame 3311 in the form of a circular area between the wing 3301 and the wall 3307 of the depression 3309 of an axle portion 3303.

In some embodiments, such as that shown in FIG. 33B, the wing 3301 is rotated between the open and closed configurations by a rod (rod) 3313. Alternatively, lever 3313 may be actuated to rotate, for example, during anchor set-up, by translating linear motion of the sliding member and handle into rotational motion. This may be achieved, for example, by a separate proximally extending member (e.g., a rod (lever), an additional rod (rod)) operably coupled to rod 3313 and the handle and/or slide member.

FIGS. 34A-34E illustrate a trocar including an axially extending and compressible structure according to some embodiments of the present invention.

In some embodiments, an axially extendable and/or compressible structure 3401 is disposed distal to the narrow portion 3403 of the trocar. In some embodiments, the structure 3401 is formed by a plurality of arms 3405, such as 4, 2, 6 or intermediate, greater or lesser number of arms, connected by one or more movable joints 3407. In some embodiments, axially opposed sets of arms, such as 3409 and 3411, can be brought closer together, such as shown in fig. 34C and in cross-section in fig. 34D, to create a frame 3413 between the closer arms through which anchors 3415 can pass, such as shown in fig. 34E.

In some embodiments, structure 3401 is compressed by fascia 3417, for example, when the trocar is pulled slightly in a proximal direction after initial insertion of the trocar.

In some embodiments, a diameter of an essentially circular frame defined between the arms is, for example, in the range of 3 to 8 mm, such as 4 mm, 6 mm, 7 mm or intermediate values, larger or smaller. In some embodiments, the defined frame is not circular, but includes other shapes, such as square, trapezoidal, or random.

In some embodiments, tissue trapped in the frame stretches slightly between the arms. Potential advantages of slightly stretching the tissue may include assisting in piercing the tissue and ensuring that the anchor is fully inserted into the tissue, for example, the anchor has penetrated the full thickness of the fascia layer.

Fig. 35A-35E are an isometric view and a cross-sectional view, respectively, of an outer sleeve 3501 including a plurality of anchors in accordance with some embodiments of the invention.

In some embodiments, the plurality of sutures 3505 are detachably connected to the inner wall of the cannula 3501 through one or more anchors 3503 therein, e.g., at a distal end portion of a hollow cylindrical shaft of the cannula 3507. In some embodiments, the connection between the plurality of anchors and the cannula is configured to allow the plurality of anchors to advance along a defined trajectory. This track is provided, for example, by an elongated trapezoidal recess defining a dovetail coupling, for example as described above.

In some embodiments, the hollow cylindrical shaft 3507 includes a textured surface, e.g., including a plurality of bumps or a plurality of protrusions, such as annular protrusions 3509, to increase the contact area between the outer wall of the cannula and the tissue. Potential advantages of the textured surface may include increased cannula resistance against inadvertent withdrawal of the cannula from the tissue. The textured surface may be effective to reduce slippage of the cannula in the tissue and/or to achieve a stronger grip of the cannula in the surrounding tissue.

In some embodiments, such as shown in fig. 35C-35E, the cannula 3507 includes a spool of one or more sutures 3515, as shown in fig. 35D. Optionally, the plurality of sutures are rolled up at the proximal portion of the cannula, such as a plurality of spools positioned horizontally on either side of the cannula head. In some embodiments, reel 3515 includes a mechanism to provide multiple sutures that are automatically retracted, such as during placement of an anchor. Optionally, the mechanism includes the use of one or more clocksprings 3517, such as shown in fig. 35E, operatively connected to the spool. One potential advantage of storing multiple sutures on the spool 351 can include reducing the risk of suture snagging and/or curling, reducing the risk of multiple sutures interfering with the passage of a tool through the cannula, reducing the risk of multiple sutures interfering with the advancement of a trocar through the cannula, and/or other advantages. In some embodiments, such as at the end of the procedure, when the outer sleeve is removed from the tissue, the plurality of suture ends are released from the sleeve and may be tied together by the user.

Fig. 36A-36B are photographs of an in vivo experiment conducted in a pig experimental model using a trocar and external cannula assembly, in accordance with some embodiments of the present invention. Fig. 36A shows that, from the abdominal direction, the distal portion 3601 of the trocar is advanced through the fascia and peritoneum 3603. In some embodiments, a distal shaft portion 3605 is shaped to produce a tissue plication effect, for example, as described above. In fig. 36B, the anchor 3607 is advanced to the tissue by a plurality of anchor barbed elements 3609. Alternatively, as shown, for example, in fig. 36B, a plurality of anchors are disposed at a slight angle from the longitudinal axis of the trocar and extend radially outward. A similar configuration of trocar and outer cannula assembly used in this experiment is shown, for example, in fig. 25A.

Fig. 37A-37F are photographs of another in vivo experiment conducted in a pig experimental model using a trocar and external cannula assembly, in accordance with some embodiments of the present invention. In fig. 37A, after initial insertion of the trocar into the abdominal cavity, the distal tip 3701 of the trocar 3713 (indicated in fig. 37D to distinguish from the outer cannula) is pulled in a proximal direction, bringing the proximally facing surface against fascia 3703 (optionally including a thin peritoneal layer). Optionally, one or more protuberances of the proximal facing surface prick the fascia slightly to obtain a stronger grip. In fig. 37B, a plurality of anchors 3705 are advanced distally with the assistance of a plurality of anchor barbed elements 3707. Optionally, the tissue is stretched in the distal direction by a plurality of anchors prior to the actual penetration. In fig. 37C, the plurality of anchor barbed elements 3707 are withdrawn proximally into the shaft of the trocar, leaving the plurality of anchors 3705 (along with the suture 3709 passed through the anchors) adjacent fascia inside the abdominal cavity (e.g., just below). In fig. 37D, the assembly comprising the trocar 3713 and the outer cannula 3711 is advanced distally in preparation for withdrawing the trocar 3713 from the outer cannula 3711. At this stage, the plurality of anchors 3705 are pulled proximally to abut fascia 3703, for example, by an automatic suture retraction mechanism as further described herein and/or manually by a user. In fig. 37E, trocar 3713 has been retracted from outer cannula 3711 and the cannula is still positioned in the tissue, providing a port for a surgical tool to be delivered, such as a laparoscope. In fig. 37F, the sleeve 3711 is removed from the tissue and the plurality of sutures 3709 are tied together to close the wound, for example by a user, such as a physician.

Fig. 38A-38C are exemplary configurations of a trocar 3801 housed in an outer cannula 3803 wherein the trocar shaft does not include a narrowed portion, in accordance with some embodiments of the present invention. In the exemplary configuration, the distal portion of the trocar 3801 is advanced through the fascia layer 3805. Alternatively, as shown in fig. 28B, for example, a dilation element 3807 coupled to and/or integral with the shaft of the trocar 3801 is expanded, e.g., radially outward relative to the trocar shaft, to urge the fascia 3805 against the deployment element. In some embodiments, such as shown in fig. 38C, the plurality of anchor barbed elements 3809 are advanced, such as pushed out of the trocar shaft, and selectively engage the plurality of anchors 3811 radially outward relative to the trocar shaft and deliver the plurality of anchors to tissue. Alternatively, a plurality of anchors 3811 may be removably connected to the outer sleeve 3803 prior to engaging the plurality of anchor barbed elements, such as: a plurality of anchors are attached to the inner wall of the cannula at the distal end of the cannula.

In some embodiments, a kit is provided that includes a trocar 3801 and one or more outer cannulas 3803.

It is anticipated that during the life of the patent from application to maturity, many relevant trocar and/or wound closure devices will be developed and the scope of the term trocar and/or wound closure device is intended to include all such new technologies in advance.

The terms "comprising," including, "" containing, "and variations thereof mean" including, but not limited to.

The term "consisting of means" including and limited to.

The term "consisting essentially of" means that a composition or method may include additional components and/or steps, but only if the additional components and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

As used herein, the singular forms "a", "an" and "at least one" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

Throughout this application, various embodiments of the invention may exist in a range of forms. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the described range descriptions should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, it is contemplated that the description of a range from 1 to 6 has specifically disclosed sub-ranges such as, for example, from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within a range such as, for example, 1, 2, 3, 4, 5, and 6, as applicable regardless of the range.

Whenever a numerical range is indicated herein, it is meant to include any number (fractional or integer) recited within the indicated range. The terms "range between" and "from" a first indicated number "to" a second indicated number "are interchangeable herein and are meant to include both the first and second indicated numbers, and all fractions and integers therebetween.

The term "method" as used herein refers to means (manner), means (means), techniques (technique) and procedures (procedures) for accomplishing a specific task, including, but not limited to, those means, techniques and procedures which are known or readily developed by practitioners of the chemical, pharmacological, biological, biochemical and medical arts from known means, techniques or procedures.

As used herein, the term "treating" includes abrogating (abrogate), essentially inhibiting (substentially inhibiting), slowing or reversing (reversing) the progression of a condition, essentially ameliorating (ameliorating) a clinical or aesthetic symptom of a condition, or essentially preventing a clinical or aesthetic symptom of a condition.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or in any other described embodiment suitable for use with the invention. The particular features described herein in the context of the various embodiments are not considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Claims

1. A kit for use in a laparoscopic procedure, comprising: the set includes:

(1) a trocar adapted for insertion through a fascia layer of an abdominal wall,

a proximal end configured for operation by a user;

a distal end configured for insertion into tissue; and

a shaft extending between said proximal end and said distal end;

(2) an outer cannula sized to receive the trocar, the cannula comprising: at least one of anchors and sutures removably attached to an inner wall of the cannula;

wherein the trocar includes an anchor advancement mechanism comprising at least one anchor piercing element configured to extend outwardly to a shaft of the trocar to engage the anchor of the outer cannula and advance the anchor into the tissue.

2. The kit of claim 1, wherein: said shaft including a narrow portion proximate said distal end, said narrow portion defining at least one recess shaped and dimensioned to receive fascia tissue, said recess terminating at a distal end of said recess, and a generally proximally facing surface of said shaft being configured to be directly beneath said narrow portion, said proximally facing surface and said narrow portion being shaped and dimensioned to stabilize said trocar within said abdominal wall via said fascia; the proximally facing surface includes a tissue engagement geometry configured to limit movement of the fascial tissue received in the recess away from the recess.

3. The kit of claim 1, wherein: the anchoring barbed element is shaped as a rod, and wherein a distal surface of the rod engages a proximal surface of the anchor.

4. The kit of claim 1, wherein: the kit further includes a plurality of outer cannulas into which the trocar may be inserted.

5. The kit of claim 4, wherein: a connection between the plurality of anchors and the outer cannula is configured to not interfere with insertion of the trocar into the cannula and advancement of the trocar to a ready-to-use position wherein the anchor barbed element is substantially positioned over the anchor.

6. The kit of claim 1, wherein: the anchor advancement mechanism is received in a shaft of the trocar until manipulated to advance the anchor into tissue.

7. The kit of claim 6, wherein: the anchor advancement mechanism further comprises a sliding element operably coupled to a handle for manipulation by a user, the sliding element comprising a geometry adapted to urge the at least one anchor piercing element distally when advanced into the shaft of the trocar.

8. The kit of claim 1, wherein: when advanced into the tissue without directly piercing the tissue, the plurality of anchors are configured to apply a force to the tissue to form a tissue fold between the anchor and at least one of the narrow portion and the recessed shaft portion configured below the narrow portion.

9. The kit of claim 1, wherein: the anchoring includes: a hollow body shaped and dimensioned to receive an anchoring barbed element; and at least one surface adapted to abut the fascia in a deployed position of the anchor.

10. The kit of claim 1, wherein: the trocar includes at least one proximally facing cutting element positioned distal to the narrow portion, the cutting element being shaped to interact with the anchor to assist the anchor in penetrating the tissue.

11. The kit of claim 1, wherein: the trocar includes a plurality of recesses along the plurality of walls of the shaft in which the plurality of anchoring spur elements are advanced or retracted, the plurality of recesses being configured to be parallel to a longitudinal axis of the shaft.

12. The kit of claim 1, wherein: the trocar includes a spring and the plurality of anchor barbed elements are automatically retracted with the spring, the spring configured to not prevent advancement of the plurality of anchors into the tissue.

13. The kit of claim 1, wherein: an inner wall of the outer sleeve includes at least one elongate recess in which at least a portion of the anchor is received, the recess defining a path for advancing the recess toward the tissue.

14. The kit of claim 13, wherein: the recess is trapezoidal and defines a dovetail-like coupling between the anchor and the sleeve.

15. The kit of claim 1 or the trocar of claim 14, wherein: at least one of the plurality of anchors and the plurality of sutures may be absorbed in tissue.

16. The kit of claim 1, wherein: a lumen of the outer sleeve is sized to deliver a laparoscope therethrough.

17. The kit of claim 1, wherein: the kit further includes a sleeve for spatially orienting the trocar within the outer cannula.

18. The kit of claim 17, wherein: the sleeve seals a lumen between the trocar and cannula to prevent escape of gas from within the abdomen.

19. The kit of claim 1, wherein: a maximum diameter of the shaft together with the outer sleeve is between 15 and 30 mm.