Apparatus and method for producing a reinforced surgical fastener suture line

• US 5,752,965 A
• Filed: 10/21/1996
• Issued: 05/19/1998
• Est. Priority Date: 10/21/1996
• Status: Expired due to Term

• Current Assignee: Synovis Life Technologies Incorporated (Baxter International Inc.)
• Original Assignee: Bio-Vascular, Inc. (Baxter International Inc.)
• Inventors: Cooper, Joel, Hughes, Mark E., Francis, Ralph T., Claeson, Anne E.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/734,113
• Time in Patent Office: 575 Days
• Field of Search: 606/148, 606/151, 606/156, 623/2, 623/11, 600/36, 600/37, 602/48, 602/50
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004

Abstract

An apparatus and method for providing reinforced surgical fastener suture lines to prevent tissue tearing and fluid leakage following the creation of an anastomosis, the closing of margins following the removal of diseased tissue, and/or the ligating and dividing of individual blood vessels. A retainer assembly is provided having an alignment frame and a pressure equalization member. The alignment frame includes an internally disposed receiving area for housing the pressure equalization member and a pair of guide channels disposed in fluid communication with the receiving area for guiding the jaw members of a surgical fastener applying device into contact with pledget material disposed within the receiving area. Any number of surgical fastener applying devices may be retrofitted to provide reinforced surgical fastener suture lines by applying an adhesive along the length of the pledget material, positioning the jaw members of a surgical fastener applying device within the guide channels, and closing the surgical fastener applying device such that the jaw members are brought into compressed contact with the adhesive-laden pledget material. The surgical fastener applying device may then be opened with the pledget material releasibly attached to the jaw members, the jaw members positioned about a section of body tissue, and the surgical fastener applying device fired to create a reinforced suture line boasting reduced tissue tearing and reduced fluid leakage.

Claims

1. An apparatus for equipping a surgical fastener applying device to provide reinforced surgical fastener suture lines, comprising:

(a) a alignment means having at least one guide channel and a receiving area, said at least one guide channel being open to said receiving area;

(b) pressure equalization means disposed within said receiving area of said alignment means; and

(c) at least one article of pledget material disposed within said receiving area in juxtaposed relation with said pressure equalization means and positioned so as to be generally co-aligned with said at least one guide channel.

2. The apparatus as set forth in claim 1 and further, said alignment means comprising a sheath portion having at least one coupling aperture from which said at least one guide channel extends generally perpendicularly therefrom.

3. The apparatus as set forth in claim 2 and further, said at least one coupling aperture having the same approximate width and length of a working surface of said surgical fastener applying device.

4. The apparatus as set forth in claim 3 and further, said at least one guide channel being dimensioned to guide said working surface of said surgical fastener applying device into contact with said at least one article of pledget material.

5. The apparatus as set forth in claim 1 and further, said at least one article of pledget material having a peripheral edge which extends laterally past said at least one coupling aperture such that said at least one article of pledget material may be releasibly retained between said alignment means and said pressure equalization means.

6. The apparatus as set forth in claim 1 and further, wherein said pressure equalization means comprises a generally deformable and resilient material capable of releasibly biasing said at least one article of pledget material into contact with said alignment means when said at least one article of pledget material is disposed within said receiving area.

7. The apparatus as set forth in claim 1 and further, wherein said at least one guide channel is beveled having an engagement surface which angles laterally outward from said alignment means.

8. A surgical kit for facilitating application of an article of pledget material to the apposed working surfaces of a surgical fastener applying device for producing reinforced surgical fastener suture lines, comprising:

an alignment means;

at least one article of pledget material having a shape that generally complements the shape of said working surface of said surgical fastener applying device;

pressure equalization means disposed in said alignment means for supporting and equalizing the pressure applied to said at least one article of pledget material during contact with said working surface of said surgical fastener applying device; and

means for temporarily securing said at least one article of said pledget material to said working surface of said surgical fastener applying device.

9. The kit as set forth in claim 8 and further, said alignment means comprising a guide channel extending from a coupling aperture, and a receiving area open to said coupling aperture for housing said pressure equalization means.

10. The kit as set forth in claim 9 and further, wherein said guide channel is beveled having an engagement surface which angles laterally outward as said guide channel extends from said coupling aperture of said alignment means.

11. The kit as set forth in claim 8 and further, said at least one article of pledget material comprising host compatible tanned animal tissue.

12. The kit as set forth in claim 11 and further, wherein said host compatible tanned animal tissue is bovine pericardium.

13. The kit as set forth in claim 8 and further, said means for temporarily securing said at least one article of said pledget material to said working surface of said surgical fastener applying device comprising a cellulose-based adhesive.

14. An apparatus for providing reinforced surgical fastener suture lines, comprising:

retainer means having means for retaining at least one article of pledget material, means for guiding a working surface of a surgical fastener applying device into contact with said at least one article of pledget material, and means for uniformly applying said at least one article of pledget material onto said working surface of said surgical fastener applying device; and

means for releasibly attaching said at least one article of pledget material to said working surface of said surgical fastener applying device.

15. The apparatus as set forth in claim 14 and further, said means for retaining said at least one article of pledget material comprising a partially enclosed receiving area and a pressure equalization member disposed therewithin, said means for guiding a working surface of a surgical fastener applying device into contact with said at least one article of pledget material comprising at least one guide channel that is open to said receiving area.

16. The apparatus as set forth in claim 15 and further, said at least one guide channel having a beveled construction.

17. The apparatus as set forth in claim 16 and further, said means for releasibly attaching said at least one article of pledget material to said working surface of said surgical fastener applying device comprising a cellulose-based adhesive.

18. The apparatus set forth in claim 15 and further, said pressure equalization member comprising a generally deformable and resilient material capable of releasibly biasing said at least one article of pledget material into contact with said receiving area.

19. The apparatus as set forth in claim 15 and further, said retainer means including a alignment means and said pressure equalization member, wherein said receiving area extends within a sheath portion of said alignment means and said at least one guide channel extends from a coupling aperture formed within said sheath portion of said alignment means such that said at least one guide channel is open to said receiving area.

20. A method of retrofitting surgical fastener applying devices to produce reinforced surgical fastener suture lines, said surgical fastener applying device having a pair of apposed working surfaces, comprising the steps of:

(a) providing retaining means for releasibly retaining an article of pledget material in physical contact with pressure equalization means;

(b) providing means for releasibly attaching said article of pledget material to one of said pair of apposed working surfaces of said surgical fastener applying device; and

(c) releasibly attaching said article of pledget material on one of said pair of apposed working surfaces of said surgical fastener applying device.

21. The method as set forth in claim 20 and further, step (c) comprising the further sub-steps of:

(i) closing said pair of apposed working surfaces of said surgical fastener applying device about said retaining means to form a compressed state wherein said article of pledget material is compressed between said pressure equalization means and one of said pair of apposed working surfaces to engage said means for releasibly attaching said article of pledget material to one of said pair of apposed working surfaces of said surgical fastener applying device; and

(ii) moving said surgical fastener applying device away from said retaining means while in said compressed state so as to remove said pressure equalization means and said article of pledget material from said retaining means; and

(iii) opening said pair of working surfaces of said surgical fastener applying device from said compressed condition so as to remove said pressure equalization means from said physical contact with said article of pledget material.