Methods and Apparatus for Delivering Tissue Treatment Compositions to Stapled Tissue

• US 20110282446A1
• Filed: 05/11/2010
• Published: 11/17/2011
• 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: Morgan, Stuart K., Morgan, Jerome R., Shelton, Frederick E. IV, Malaviya, Prasanna, McAlister, Gary B., Schulte, John B., Witt, David A., Mollere, Rebecca J., Balek, Stephen J., Cronin, Michael D., Widenhouse, Tamara S. Vetro, Schowalter, Joseph P., Dugan, Patrick D.
• Granted Patent: US 8,646,674 B2
• Time in Patent Office: Days
• US Class Current: 623/11.11
• 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, and

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

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; 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 one or more medical fluids to the pouch.

4. The surgical stapling kit of claim 1, wherein the tissue treatment member is further configured to be attached to 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 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. A method of using a stapling instrument to staple tissue in a patient, wherein the stapling instrument comprises a handle, first and second opposed clamping members coupled with the handle, a rupturable tissue treatment member, and a knife member, wherein the first clamping member includes a plurality of staples, wherein the second clamping member includes an anvil configured to form the staples, wherein the tissue treatment member includes a medical fluid having at least one tissue fragment, the method comprising:

(a) positioning at least two layers of tissue between the first and second clamping members;

(b) clamping the at least two layers of tissue with the first and second clamping members;

(c) driving the staples into the at least two layers of tissue; and

(d) cutting portions of the at least two layers of tissue with the knife member;

wherein the tissue treatment member is ruptured to administer the medical fluid to the tissue.

14. The method of claim 13, further comprising:

(a) harvesting at least one viable tissue specimen from the patient;

(b) mincing the tissue specimen into a plurality of tissue fragments having a plurality of viable cells; and

(c) inserting the tissue fragments into the tissue treatment member.

15. The method of claim 14, wherein the plurality of tissue fragments are combined with a carrier to form a suspension, wherein the act of inserting comprises injecting the suspension of tissue fragments into the tissue treatment member.

16. The method of claim 13, wherein the tissue treatment member comprises a pouch, the method further comprising positioning the pouch between the first and second clamping members.

17. The method of claim 13, wherein the tissue treatment member comprises a sleeve, the method further comprising inserting the first clamping member or the second clamping member into the sleeve.

18. The method of claim 13, wherein the tissue treatment member comprises a film selectively adhered to one of the clamping members, wherein the film defines a fluid reservoir, the method further comprising injecting the at least one tissue fragment into the fluid reservoir.

19. The method of claim 13, wherein the at least two layers of tissue are provided by two separate tissue lumen ends, wherein the act of positioning further comprises positioning the two tissue lumen ends adjacent to each other.

20. A biocompatible scaffold, comprising:

(a) an annular disc portion having an outer circumferential edge; and

(b) a plurality of tabs extending radially away from the outer circumferential edge of the annular disc portion;

wherein the scaffold is positionable on an end effector shaft extending between a stapling head and an anvil of a circular surgical stapler.