Medical devices and methods useful for applying bolster material

• US 20060004407A1
• Filed: 02/17/2005
• Published: 01/05/2006
• Est. Priority Date: 02/17/2004
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Patel, Umesh H., Shah, Bhavin, Hiles, Michael C., McAlexander, Chad S.
• Granted Patent: US 8,920,443 B2
• Time in Patent Office: Days
• US Class Current: 606/215
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• 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 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 50/20 Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02

Abstract

Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.

Claims

1. A medical device useful for applying a bolster material to a surgical fastening device having a first arm and a second arm presenting respective first arm and second arm surfaces, the medical device comprising:

an applicator element which is receivable between the first and second arms, said applicator element having a first side and a second side;

at least one piece of bolster material coupled to the applicator element and presented at least at said first side of said applicator element for contact with at least said first arm surface.

2. The medical device of claim 1, wherein said bolster material is coupled to said applicator element by bonding or by having at least one portion received through or around said applicator element.

3. The medical device of claim 2, wherein said bolster material has at least a portion received through said applicator element.

4. The medical device of claim 2, wherein said bolster material has at least one portion received around said applicator element.

6. The medical device of claim 1, wherein the bolster material comprises collagen.

7. The medical device of claim 6, wherein the bolster material comprises an extracellular matrix material.

8. The medical device of claim 7, wherein the extracellular matrix material comprises submucosa.

9. The medical device of claim 8, wherein the submucosa is small intestinal submucosa.

10. The medical device of claim 9, wherein the small intestinal submucosa is porcine.

14. The medical device of any of claims 1, wherein the applicator element comprises a compressible material.

28. The medical device of any of claim 1, wherein said applicator element includes at least one lateral portion adapted for grasping when the applicator element is received between said arms.

29. A method for applying a bolster material to a surgical fastening device having opposed arm surfaces, comprising:

positioning between the opposed arm surfaces a medical device according to claim 1;

approximating the arm surfaces so as to contact and adhere the bolster material to said arm surfaces;

uncoupling the bolster material from the applicator element; and

separating said first and second arm surfaces.

11. (canceled)

12. (canceled)

13. (canceled)

15. (canceled)

16. A medical device for applying a bolster material to a surgical fastening apparatus having opposed arm surfaces, comprising:

an applicator element for receipt between the opposed arm surfaces; and

a loop of bolster material positioned around the applicator element.

17. The medical device of claim 16, wherein the bolster material comprises collagen.

18. The medical device of claim 16, wherein the staple bolster material comprises an extracellular matrix material.

19. The medical device of claim 18, wherein the extracellular matrix material comprises submucosa.

22. The medical device of claim 16, wherein the loop of bolster material includes at least one premanufactured disruption point.

23. The medical device of claim 22, wherein the premanufactured disruption point includes first and second ends releasably connected to one another.

24. The medical device of claim 22, wherein the premanufactured disruption point includes a weakened portion of the bolster material.

26. The medical device of claim 16, wherein the applicator element includes an engaging portion, wherein the bolster material defines at least one aperture, and wherein said engaging portion is received through said aperture.

27. The medical device of claim 26, wherein:

said bolster material defines at least a first aperture and a second aperture;

said bolster material is wrapped around said applicator element; and

said engaging portion is received through said first aperture and said second aperture.

30. A method for applying a bolster material to a surgical fastening device having opposed arm surfaces, comprising:

positioning between the opposed arm surfaces a medical device according to claim 16;

approximating the arm surfaces so as to contact and adhere the bolster material to said arm surfaces;

disrupting the loop of bolster material; and

separating said first and second arm surfaces.

35. The method of claim 30, wherein said disrupting includes disconnecting releasably connected ends of the bolster material.

36. The method of claim 30, wherein said disrupting comprises releasing the bolster material from an engaging portion of said applicator element received through the bolster material.

20. (canceled)

21. (canceled)

25. (canceled)

31. (canceled)

32. (canceled)

33. (canceled)

34. (canceled)

37. (canceled)

38. (canceled)

39. A medical device for applying a bolster material to a surgical fastening device having opposed arm surfaces, comprising:

an applicator element having at least one aperture; and

a bolster material;

wherein said bolster material has at least one portion received through the at least one aperture in the applicator element.

40. A medical device for applying a bolster material to a surgical fastening device, comprising:

an applicator element; and

a bolster material retained in association with said applicator element by bonding, or by at least a portion of said bolster material received around or through at least a portion of said applicator element.

41. A medical device for applying a bolster material to a surgical fastening device, comprising:

an applicator element; and

a bolster material retained in association with said applicator element;

wherein at least one of said applicator element and said bolster material at least one weakened portion adapted to facilitate separation of the applicator element of bolster material, respectively, at the weakened portion.

42. (canceled)

43. A bolster material, comprising:

bolster material configured for application to an arm of a surgical fastening device; and

a dried, reversible adhesive coating on said bolster material.

44. A medical device comprising:

a layer of dried, collagenous extracellular matrix material; and

a dried, reversible adhesive coating on said layer.

45. The medical device of claim 44, wherein said sheet and said coating are lyophilized.

46. The medical device of claim 45, wherein said sheet comprises submucosa of a warm-blooded vertebrate.

47. (canceled)

48. (canceled)

49. (canceled)

50. (canceled)

51. (canceled)

52. A method for applying a bolster material to a surgical fastening device having opposed arm surfaces, comprising:

positioning between the opposed arm surfaces a medical device consisting essentially of a compressible applicator element and a bolster material coupled to the applicator element;

approximating the opposed surfaces so as to contact and adhere the bolster material to at least one of said opposed surfaces; and

separating said first and second opposed surfaces.

53. A medical device useful for applying a bolster material to a surgical fastening device having a first arm and a second arm presenting respective first arm and second arm surfaces, the medical device comprising:

an applicator element comprised of a foam material, said applicator element being receivable between the first and second arms of the surgical fastening device and having a first side and a second side, said foam material having a generally rectangular receiving area;

a first piece of bolster material retained in association with the applicator element and presented at said first side of said applicator element for contact with said first arm surface said first piece of bolster material being a collagenous extracellular matrix material processed so as to retain one or more bioactive growth factors native to a source tissue from which the extracellular matrix material is derived; and

a second piece of bolster material retained in association with the applicator element and presented at said second side of said applicator element for contact with said second arm surface said second piece of bolster material being a collagenous extracellular matrix material processed so as to retain one or more bioactive growth factors native to a source tissue from which the extracellular matrix material is derived.

54. A method for fastening lung tissue, comprising:

providing a surgical fastening device, said surgical fastening device having a first arm and a second arm presenting respective first arm and second arm surfaces;

providing a medical device for applying a bolster material to the surgical fastening device, the medical device comprising;

an applicator element comprised of a foam material, said applicator element being receivable between the first and second arms of the surgical fastening device and having a first side and a second side, said foam material having a generally rectangular receiving area;

a first generally rectangular piece of bolster material retained in association with the applicator element and presented at said first side of said applicator element for contact with said first arm surface said first piece of bolster material being a collagenous extracellular matrix material processed so as to retain one or more bioactive growth factors native to a source tissue from which the extracellular matrix material is derived; and

a second generally rectangular piece of remodelable pericardium bolster material retained in association with the applicator element and presented at said second side of said applicator element for contact with said second arm surface said second piece of bolster material being a collagenous extracellular matrix material processed so as to retain one or more bioactive growth factors native to a source tissue from which the extracellular matrix material is derived;

positioning between the first arm surface and the second arm surface the medical device;

approximating the first arm surface and the second arm surface so as to contact and adhere the first piece of remodelable pericardium bolster material to the first arm surface and the second piece of bolster material to the second arm surface;

disassociating the applicator element from the first piece of bolster material and the second piece of bolster material;

separating the first arm surface and the second arm surface; and

operating the surgical fastening device so as to insert a fastener into lung tissue bolstered by said first and second pieces of bolster material.

55. A medical device useful for applying a bolster material to a surgical fastening device having a first arm and a second arm presenting respective first arm and second arm surfaces, the medical device comprising:

an applicator element which is receivable between the first and second arms of the surgical fastening device, said applicator element having a first side and a second side; and

at least one piece of remodelable extracellular matrix bolster material retained in association with the applicator element and presented at least at said first side of said applicator element for contact with at least said first arm surface.

56. The medical device of claim 55, wherein the bolster material comprises pericardium tissue including at least one retained bioactive component.