HK1097171B - Sheath for enabling insertion and extraction of anastomotic ring applier - Google Patents

Description

FIELD OF THE INVENTION

The present invention relates to a device for performing a surgical procedure on the digestive system.

BACKGROUND OF THE INVENTION

The percentage of the world population suffering from morbid obesity is steadily increasing. Severely obese persons may be susceptible to increased risk of heart disease, stroke, diabetes, pulmonary disease, and accidents. Because of the effects of morbid obesity on the life of the patient, methods of treating morbid obesity have been the subject of intense research.

One known method for treating morbid obesity includes the use of anastomotic rings. Devices for applying anastomotic rings are known in the art. Devices of this nature are commonly adapted to insert a compressed anastomotic ring to an anastomotic opening formed between proximate gastrointestinal tissue walls. These applier devices may utilize a ring deployment mechanism comprising an expansion element that is actuated once the compressed ring is placed in the anastomotic opening, causing the anastomotic ring to expand from its compressed, cylindrically-shaped position to an actuated, hollow rivet-shaped position. For example, EP 1520531 A discloses an anastomotic ring applier using such a ring deployment mechanism.

With some conventional anastomotic ring applier devices that use fingers or similar members to expand anastomotic rings, it may be possible for tissue to be trapped between the fingers of the applier device when it is inserted adjacent the proximate gastrointestinal tissue walls. Similarly, it may be possible for tissue to become trapped in the deployment mechanism during extraction of the device from the anastomosis site. The trapping of tissue between the fingers may result in undesirable consequences, such as pinching or tearing of the tissue, or even a compromise in the integrity of the anastomosis.

Some anastomotic ring applier devices known in the art incorporate a tubular sheath that is slideably located on the elongated shaft. The tubular sheath is typically in position over the ring deployment mechanism while the device is inserted adjacent the anastomosis site and during extraction of the device, and may be retracted to allow deployment of the ring. Thus, it may be desirable to have an anastomotic ring applier device that provides a reduced likelihood of tissue becoming trapped in the ring deployment mechanism of the device, yet does not necessarily require the time and a mechanism to retract a sheath from the fingers of the device.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a surgical instrument operable for implanting an anastomotic ring device as claimed hereinafter.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate versions of the invention, and, together with the general description of the invention given above, and the detailed description of the versions given below, serve to explain the principles of the present invention.

FIGURE 1 is a perspective view of an anastomotic ring applier device.

FIGURE 2 is a partial perspective view of the distal portion of an anastomotic ring applier device holding an anastomotic ring in an unactuated position.

FIGURE 3 is a partial perspective view of the distal portion of the device of FIGURE 2 shown without a sheath holding an anastomotic ring in the actuated position.

FIGURE 4 is a frontal view of an actuated anastomotic ring.

FIGURE 5 is a perspective view of the anastomotic ring applier device of FIGURE 1 with the distal portion of its ring deployment mechanism actuated.

FIGURE 6 is a perspective of the device of FIGURE 1 with both the distal portion and the proximal portion of its ring deployment mechanism actuated.

FIGURE 7 is a perspective exploded view of the anastomotic ring deployment mechanism of the device of FIGURE 1.

FIGURE 8 is a perspective, cross-sectional exploded view of a proximal portion of the device of FIGURE 1 with a left housing half omitted.

FIGURE 9 is a partial cross-sectional view of the distal portion of the device of FIGURE 1 inserted through an anastomotic opening.

FIGURE 10 is a partial cross-sectional view of the distal portion of the device of FIGURE 1 forming an anastomotic attachment between proximate gastrointestinal tissue walls.

FIGURE 11 is a partial cross-sectional view of a proximal portion of the device of FIGURE 1.

FIGURE 12 is a cross-sectional view taken along Plane 12 of FIG. 11.

FIGURE 13 is a cross-sectional view taken along Plane 13 of FIG. 11.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Turning to the Drawings, wherein like numerals denote like components throughout the several views, FIG. 1 depicts an applier 10 that is operable to deploy and actuate an anastomotic ring device (not pictured in FIG. 1) from a generally cylindrical shape to one having properties of a hollow rivet, or ring, capable of forming an anastomotic attachment at an anastomosis target site, such as in a bariatric gastric bypass of a morbidly obese patient. FIG. 2 depicts another applier 12. It will be appreciated that appliers 10, 12 may be used in a variety of ways, including but not limited to laparoscopically or endoscopically. Applier 12 is shown in FIG. 2 with an anastomotic ring 14 on a deployment mechanism 16. In FIG. 2, anastomotic ring 14 is shown in the compressed, cylindrically-shaped position. In FIG. 3, deployment mechanism 16 of applier 12 has moved anastomotic ring 14 to the actuated, hollow rivet-shaped position. FIG. 4 is a close-up view of anastomotic ring 14 in the actuated position. Anastomotic ring 14 may comprise a shape memory effect (SME) material, such as nitinol by way of example only, that further assists in actuation to an engaging hollow rivet shape. Other suitable anastomotic ring 14 materials will be apparent to those of ordinary skill in the art. An exemplary anastomotic ring 14 is described in detail in U.S. Patent Application Publ. No. US 2003/0032967 to Park et al.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a clinician gripping a handle of applier 10. It will be further appreciated that for convenience and clarity, spatial terms such as "right", "left", "vertical" and "horizontal" are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. In addition, aspects of the invention have application to surgical procedures performed endoscopically and laparoscopically, as well as an open procedure or other procedures. Use herein of one of these or similar terms should not be construed to limit the present invention for use in only one category of surgical procedure.

Referring again to FIG. 1, applier 10 of the present example comprises a handle 17 connected to an elongated shaft 18 having a proximal end 20 and a distal end 22. As shown in FIG. 1, elongated shaft 18 is flexible, either along its entire length or at one or more joints. Of course, shaft 20 may alternatively be rigid, resilient, malleable, or have other properties. Distal end 22 of shaft 18 comprises a ring deployment mechanism 24. Deployment mechanism 24 may be actuated by a button or lever located on handle 17. As shown in FIG. 1, handle 17 comprises a pair of actuator members 26, 28. In the present example, actuator members 26, 28 comprise sliders. The functioning of exemplary actuator sliders 26, 28 will be described below. It will be appreciated, however, that actuator members 26, 28 may take a variety of other forms and have a variety of other functions.

In the present example, ring deployment mechanism 24 is located proximal to a tip 30. Applier 10 includes a feature to prevent tissue from becoming trapped in deployment mechanism 24 when applier 10 is inserted or extracted from the anastomosis site. In FIG. 1, a proximal sheath 32 and a distal sheath 34 are pictured.

Referring to FIG. 7, ring deployment mechanism 24 of the present example is shown in an exploded perspective view, demonstrating how proximal sheath 32 fits over a plurality of proximal fingers 36, and distal sheath 34 fits over a plurality of distal fingers 38. Ring deployment mechanism 24 comprises a stationary molded actuation member 40. Of course, molded actuation member 40 may be formed using any suitable method other than molding. In the present example, molded actuation member 40 comprises proximal fingers 36 and distal fingers 38. Molded actuation member 40 also has central portion 46, which is fixedly connected to middle tube 45. Middle tube 45 fixed in distal end 22 of shaft 18. Proximal fingers 36 are connected to first actuator slider 26 via push/pull cables 42 of shaft 18 (FIG. 12). Push/pull cables 42 are in communication with an outer tube 43, which is fixedly connected with proximal fingers 36. Distal fingers 38 are connected to second actuator slider 28 via an inner tubes 44A, 44B of shaft 18 (FIG. 13). Inner tube 44A is fixedly connected with inner tube 44B. Proximal fingers 36 and distal fingers 38 are each in a double-hinged relationship with a central portion 46 of molded actuation member 40. Other suitable configurations for ring deployment mechanism 24 will be apparent to those of ordinary skill in the art.

FIGS. 8 and 11 show exemplary components of handle 17. In the present example, distal movement of first actuator slider 26 communicates distal motion to proximal fingers 36 via push/pull cables 42, thereby causing proximal fingers 36 to actuate outwardly in the manner of an umbrella due to their hinged relationship with central portion 46. Similarly, proximal movement of second actuator slider 28 communicates proximal motion to distal fingers 38 via inner tubes 44A, 44B, causing distal fingers 38 to actuate outwardly due to their hinged relationship with central portion 46. Thus, in this example, distal motion of first actuator slider 26 actuates a proximal portion of anastomotic ring 14 from the compressed position to the actuated position, while proximal motion of second actuator slider 28 actuates a distal portion of anastomotic ring 14 from the compressed position to the actuated position. In another embodiment, handle 17 is configured such that first actuator slider 26 is in communication with distal fingers 38, while second actuator slider 28 is in communication with proximal fingers 36. Suitable configurations for accomplishing such relationships will be apparent to those of ordinary skill in the art. Alternatively, any other suitable means, method, or mechanism for actuating an anastomotic ring from a compressed position to an actuated position may be used.

Fingers 36, 38 are configured to hold an anastomotic ring by engaging petals prior to and during deployment of the anastomotic ring, and release petals 52 upon deployment of the anastomotic ring. Proximal fingers 36 and distal fingers 38 of the present example comprise gripping slots, each of which include an inwardly-directed retention tip. Gripping slots may assist in retaining anastomotic ring 14 when it is in the compressed position, while retention tip may allow anastomotic ring 14 to disengage from petals of anastomotic ring 14 after it has been deployed in the actuated position. Other suitable configurations for fingers 36, 38 will be apparent to those of ordinary skill in the art.

As shown in FIG. 7, ring deployment mechanism 24 includes gaps between proximal fingers 36 and between distal fingers 38. Proximal sheath 32 is adapted to cover proximal fingers 36, and distal sheath 34 is adapted to cover distal fingers 38 in order to prevent tissue from becoming lodged in gaps during insertion and extraction of applier 10. As shown in FIG. 5, distal sheath 34 is adapted to move to an actuated position along with distal fingers 38 in response to proximal movement by second actuator slider 28. This allows distal sheath 34 to prevent tissue from becoming trapped in gaps during insertion or extraction of applier 10 without interfering with deployment of anastomotic ring 14 or requiring the surgeon to take the extra time and effort to retract the sheath. FIG. 6 shows both proximal fingers 36 and distal fingers 38 moved to the expanded position as a result of movement of actuator sliders 26, 28.

Proximal and distal sheaths 32, 34 may be affixed to proximal and distal fingers 36, 38, respectively, by an adhesive, such as glue, by mechanical fasteners, or any other suitable means or method. In one embodiment, proximal and distal sheaths 32, 34 comprise an elastomeric material that expands with proximal and distal fingers 36, 38, respectively. In another embodiment, proximal and distal sheaths 32, 34 are made of braided thread. Even if the thread material has no elasticity, it may dilate readily, ensuring coverage of gaps while allowing fingers 36, 38 to move to the expanded position. Other suitable materials and configurations for sheaths 32, 34 will be apparent to those of ordinary skill in the art.

In one example of operation, anastomotic ring 14 is held on ring deployment mechanism 24 by gripping slots of proximal and distal fingers 36, 38. Applier 10 is inserted adjacent the anastomosis site, where an opening is formed in two proximate gastrointestinal passages, as shown in FIG. 9. As applier 10 is inserted, proximal and distal sheaths 32, 34 act to prevent tissue from becoming trapped in gaps. Of course, sheaths 32, 34 may serve a variety of other purposes.

Referring now to FIG. 10, once ring deployment mechanism 24 is inserted into the anastomotic opening, first and second actuator sliders 26, 28 may be moved to their respective activated positions, causing fingers 36, 38 to actuate outwardly. This may expand anastomotic ring 14 from its compressed, cylindrical-shaped position to its actuated, hollow rivet-shaped position, forming an anastomotic attachment between the gastrointestinal tissue walls. Other applications and methods of operating applier 10 will be apparent to those of ordinary skill in the art.

Having shown and described various embodiments and concepts of the invention, further adaptations of the systems described herein can be accomplished by appropriate modifications by one of ordinary skill in the art. Several of such potential alternatives, modifications, and variations have been mentioned, and others will be apparent to those skilled in the art in light of the foregoing teachings. Accordingly, the invention is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims (15)

1. A surgical instrument (10) for implanting an anastomotic ring device (14), comprising:

   (i) a handle (17);

   (ii) a ring deployment mechanism (24) configured to receive an anastomotic ring (14), wherein the ring deployment mechanism is adapted to move between an unactuated, generally cylindrical position and an actuated, hollow rivet-forming position;

   (iii) an actuation mechanism (26, 28) for communicating actuating force to the ring deployment mechanism;

   (iv) an elongate shaft (18) connecting the handle to the ring deployment mechanism and operatively configured to transfer the actuating force from the handle to the ring deployment mechanism; characterised by:

   (v) a sheath (32, 34) adapted to cover the ring deployment mechanism during insertion and extraction of the instrument, wherein the sheath is adapted to move from the unactuated position to the actuated position along with the ring deployment mechanism.
2. The surgical instrument (10) of Claim 1, wherein the sheath (32, 34) comprises an elastomeric polymer.
3. The surgical instrument (10) of Claim 1, wherein the sheath (32, 34) comprises a braided material.
4. The surgical instrument (10) of Claim 3, wherein the braided material is dilatable.
5. The surgical instrument (10) of Claim 1, wherein said ring deployment mechanism (24) comprises: a proximal portion (36) moveable from the unactuated position to the actuated position to deploy a proximal portion of the anastomotic ring (14), and a distal portion (38) moveable from the unactuated position to the actuated position to deploy a distal portion of the anastomotic ring.
6. The surgical instrument (10) of Claim 5, wherein the sheath comprises a proximal portion (32) adapted to cover the proximal portion of the ring deployment mechanism (36) and a distal portion (34) adapted to cover the distal portion of the ring deployment mechanism (38).
7. The surgical instrument (10) of Claim 6, wherein the actuation mechanism comprising a first actuator (26) to communicate motion to the proximal portion of the ring deployment mechanism (36) and a second actuator (28) to communicate motion to the distal portion of the ring deployment mechanism (38).
8. The surgical instrument (10) of Claim 7, wherein actuation of the first actuator (26) moves both the proximal portion of the ring deployment mechanism (36) and the proximal portion of the sheath (32) from the unactuated position to the actuated position.
9. The surgical instrument (10) of Claim 7, wherein actuation of second actuator (28) moves both the distal portion of the ring deployment mechanism (38) and the distal portion of the sheath (34) from the unactuated position to the actuated position.
10. The surgical instrument (10) of Claim 1, wherein the sheath (32, 34) is secured to the ring deployment mechanism (24) by adhesive.
11. The surgical instrument (10) of Claim 1, wherein the elongated shaft (18) comprises a proximal end (20) and a distal end (22), the distal end having an axis defining longitudinal and radial directions.
12. The surgical instrument (10) of Claim 11, wherein the ring deployment mechanism (24) comprises a longitudinal end (36, 38) in alignment with the elongated shaft (18) and a center portion (46) positioned at the distal end of the elongated shaft.
13. The surgical instrument (10) of Claim 12, wherein the actuation mechanism (26, 28) is adapted to move the longitudinal end of the ring deployment mechanism (36, 38) toward the centre portion (46) to actuate the anastomotic ring (14).
14. The surgical instrument (10) of Claim 13, wherein the sheath (32, 34) is adapted to cover at least a portion of and move along with the longitudinal end of the ring deployment mechanism (36, 38).
15. The surgical instrument (10) of Claim 11, wherein the ring deployment mechanism (24) comprises a plurality of members (36, 38) operable to move in the radial direction from the unactuated position to the actuated position, and the sheath (32, 34) is adapted to cover at least a portion of the plurality of members and move from the unactuated position to the actuated position along with the corresponding members.