Methods and apparatus for delivering tissue treatment compositions to stapled tissue

• US 8,646,674 B2
• Filed: 05/11/2010
• Issued: 02/11/2014
• Est. Priority Date: 05/11/2010
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Schulte, John B., Mollere, Rebecca J., Dugan, Patrick D., Cronin, Michael D., Morgan, Jerome R., Morgan, Stuart K., McAlister, Gary B., Widenhouse, Tamara S. Vetro, Balek, Stephen J., Schowalter, Joseph P., Witt, David A., Malaviya, Prasanna, Shelton, Frederick E. IV
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US12/777,424
• Publication Number:
  US 20110282446A1
• Time in Patent Office: 1,372 Days
• Field of Search: 227/175.1, 227/175.2, 227/175.4, 227/176.1, 227/177.1, 227/178.1, 227/179.1, 227/180.1, 227/181.1, 227/182.1
• US Class Current: 227/179.1
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40

Abstract

A surgical stapler includes first and second tissue clamping members and a knife member. The first tissue clamping member is configured to receive a plurality of staples. The second tissue clamping member comprises an anvil configured to form the staples. A tissue treatment member is positionable between the first and second tissue clamping members. The tissue treatment member comprises a rupturable pouch or baffle that is configured to receive a medical fluid including at least one tissue cell. The tissue treatment member may have a spiral shape, an annular disc shape, or an elongate sleeve shape. The tissue treatment member may also include outwardly extending tabs. The tissue treatment member may also include an injection port. In use, the staples and/or the knife pierce the tissue treatment member to release at least a portion of the medical fluid held by the tissue treatment member.

Claims

1. A surgical stapling kit for stapling tissue, comprising:

(a) a stapling instrument comprising;

(i) a handle,

(ii) a first clamping member, wherein the first clamping member is configured to receive a plurality of staples, wherein the first clamping member comprises a first fluid passageway,

(iii) a second clamping member opposed to the first clamping member, wherein the second clamping member comprises an anvil for forming the staples, and

(iv) a reservoir, wherein the reservoir is configured to store a tissue treatment composition, wherein the reservoir comprises a second fluid passageway, wherein the second fluid passageway is couplable with the first fluid passageway to selectively deliver the tissue treatment composition to a position between the first and second clamping members,

wherein one or both of the first or second clamping members are coupled with the handle,

wherein the second clamping member is movable between an open position for receiving tissue and a closed position for stapling tissue between the clamping members

wherein the second fluid passageway is configured to couple with the first fluid passageway in response to movement of the second clamping member to the closed position, wherein the second fluid passageway is configured to decouple from the first fluid passageway in response to movement of the second clamping member to the open position; and

(b) a biocompatible, rupturable tissue treatment member, wherein the tissue treatment member is configured to receive and retain a tissue treatment composition comprising a medical fluid, wherein the tissue treatment member is further configured to be positioned between the first and second clamping members such that, when tissue is clamped and stapled between the clamping members, the tissue treatment member releases at least a portion of the fluid tissue treatment composition retained by the tissue treatment member.

2. The surgical stapling kit of claim 1, wherein the tissue treatment member comprises a rupturable pouch.

3. The surgical stapling kit of claim 2, wherein the pouch includes a self-sealing port for adding the medical fluid to the pouch.

4. The surgical stapling kit of claim 1, wherein the tissue treatment member is further configured to be attached to the tissue prior to the tissue treatment member being alignably positioned between said first and second clamping members of the stapling instrument.

5. The surgical stapling kit of claim 1, wherein the stapling instrument comprises a circular stapler, wherein the first clamping member is configured to receive a plurality of staples in at least one circular array, wherein the stapling instrument further comprises an elongate shaft extending between the first and second clamping members, and wherein the tissue treatment member is configured to be slidingly positioned on the shaft.

6. The surgical stapling kit of claim 5, wherein the tissue treatment member comprises a toroid sized so that when the tissue treatment member is positioned on the shaft extending between the first and clamping members of the stapling instrument, and the tissue is clamped and stapled between the clamping members, the tissue treatment member will be ruptured by the staples.

7. The surgical stapling kit of claim 6, wherein the tissue treatment member comprises a spiral toroid defining a central opening configured to receive the shaft extending between the first and second clamping members of the stapling instrument.

8. The surgical stapling kit of claim 1, wherein the stapling instrument further comprises a knife operably movable between the first and second clamping members, wherein when tissue is clamped and stapled between the first and second clamping members, the knife cuts through the tissue and the tissue treatment member.

9. The surgical kit of claim 1, wherein the tissue treatment member is positioned between said first and second clamping members.

10. The surgical kit of claim 1, wherein the tissue treatment member is provided in a sealed package separate from the stapling instrument and is positionable between the first and second clamping members after receiving a tissue treatment composition.

11. The surgical kit of claim 1, wherein the tissue treatment member is generally disc shaped and includes a plurality of tabs extending radially outwardly.

12. The surgical kit of claim 1, wherein the tissue treatment member contains at least one tissue cell configured to form a sphincter, wherein the tissue treatment member further comprises a plurality of fibers arranged in a pattern selected from the group consisting of concentric circles, spirals, or spheres.

13. The surgical kit of claim 1, wherein the reservoir is positioned within the handle.

14. The surgical kit of claim 1, wherein the reservoir comprises an inlet port, wherein the inlet port is configured to receive the tissue treatment composition.

15. The surgical kit of claim 14, wherein the inlet port comprises a valve, wherein the valve is configured to selectively open the inlet port.

16. The surgical kit of claim 1, wherein the reservoir comprises a tissue mincer.

17. The surgical kit of claim 1, wherein the reservoir comprises a piston, wherein the piston is operable to translate the tissue treatment composition from the reservoir through the fluid conduit.

18. The surgical kit of claim 17, wherein the reservoir comprises an actuator, wherein the actuator is operable to selectively actuate the piston.

19. A surgical stapling instrument comprising:

(a) a handle;

(b) a first clamping member, wherein the first clamping member is configured to receive a plurality of staples;

(c) a second clamping member opposed to the first clamping member, wherein the second clamping member comprises an anvil for forming the staples; and

(d) a reservoir, wherein the reservoir is configured to store a tissue treatment composition, wherein the reservoir comprises a fluid conduit operable to deliver the tissue treatment composition to a position between the first and second clamping members, wherein the fluid conduit is configured to selectively couple with one of either the first or second clamping member;

wherein one or both of the first or second clamping members are coupled with the handle;

wherein at least one of the clamping members is movable between an open position for receiving tissue and a closed position for stapling tissue between the clamping members

wherein the fluid conduit is configured to couple with one of either the first or second clamping members in response to movement of the at least one of the clamping members to the closed position, wherein the fluid conduit is configured to decouple with the first or second clamping member in response to movement of the at least one of the clamping members to the open position.

20. A surgical stapling instrument comprising:

(a) a handle;

(b) a stapling head assembly, wherein the stapling head assembly comprises staples and a movable member having a first fluid port;

(c) an anvil assembly, wherein the anvil assembly is configured to selectively couple with the movable member of the stapling head assembly, wherein the anvil assembly includes an anvil for forming the staples, wherein the movable member is operable to move the anvil assembly relative to the stapling head assembly between an open position for receiving tissue and a closed position for stapling tissue between the stapling head assembly and the anvil assembly;

(d) a shaft extending between the handle and the stapling head assembly, wherein the shaft includes a second fluid port, wherein the first fluid port is configured to fluidly communicate with the second fluid port when the anvil assembly is in the closed position, wherein the first fluid port is configured to be fluidly isolated from the second fluid port when the anvil assembly is in the open position; and

(d) a reservoir, wherein the reservoir is configured to store a tissue treatment composition, wherein the reservoir is in fluid communication with the second fluid port.