Device and method for sealing tissue

• US 5,895,412 A
• Filed: 05/02/1997
• Issued: 04/20/1999
• Est. Priority Date: 10/11/1995
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Fusion Medical Technologies Inc. (Baxter International Inc.)
• Inventors: Tucker, Robert
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/850,549
• Time in Patent Office: 718 Days
• Field of Search: 606/214, 606/215, 606/216, 606/213, 222/146.5, 525/54.1, 424/450
• 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 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/00513 Tissue soldering

Abstract

An apparatus and method for effecting and enhancing wound closure in tissue is disclosed. Wounds and tissue are sealed by heating a sealant material, such as collagen, in an applicator (10) to a temperature sufficient to melt the sealant. The melted sealant is then extruded through a distal tip of an elongate shaft (22) and applied to the target site, where it cools and sets to form bonds with the underlying tissue. The heated sealant flows over the wound to create an effective barrier against further blood leakage and, upon cooling, it readily adheres to the tissue to seal the wound. In addition, since high intensity energy is not applied directly to the wound, damage or destruction of neighboring tissue is minimized.

Claims

1. A method for applying a sealant material to a target site on tissue, said method comprising:

providing a reservoir of the sealant material;

heating the sealant material;

applying the heated sealant material to the target site under conditions which denature surface proteins in the tissue at the target site;

applying RF energy from an external probe to the sealant material; and

allowing the sealant material to cool and set at the target site.

2. The method of claim 1 wherein the sealant material is heated to a temperature from 70°

C. to 110°

C.

3. The method of claim 1 wherein the sealant material comprises at least one of a biologic polymer and a synthetic organic polymer.

4. The method of claim 3 wherein the sealant material is a biologic polymer comprising a protein selected from the group consisting of collagen, fibrin, fibrogen, elastin, serum albumin, fibronectin, hemoglobin, ovalbumin and combinations thereof.

5. The method of claim 3 wherein the sealant material is a synthetic organic polymer selected from the group consisting of lactic acid, glycolic acid, hydroxybutyrate, phosphazine, polyester, polyethylene glycol, polyethylene oxide, polyacrylamide, polyhydroxyethylmethacrylate, poly-vinylpyrrolidon, poly-vinyl-alcohol, polyacrylic acid, polylactate, polycaprolactone, polypropylene, nylon and combinations thereof.

6. The method of claim 3 wherein the sealant material is present at from 25% to 75% by weight in a liquid carrier.

7. The method of claim 6 wherein the sealant material comprises collagen.

8. The method of claim 6 wherein the sealant material comprises gelatin.

9. The method of claim 6 wherein the liquid carrier comprises an aqueous solution of polyethylene glycol.

10. The method of claim 1 wherein the sealant material is heated by extruding the sealant material through a heated lumen.

11. The method of claim 1 wherein the heated sealant material is applied to form a layer on a wound in tissue, the method further comprising approximating the tissue together over the wound.

12. The method of claim 1 wherein the applying step comprises substantially filling a body cavity with the sealant material.

13. The method of claim 11 wherein the wound is a surgical incision or puncture.

14. The method of claim 11 wherein the wound is present in the serosal and underlying tissue of an internal body organ.

15. The method of claim 14 wherein the internal body organ is selected from the group consisting of small and large bowels, lungs, stomach, liver, esophagus, bladder, uterus, ovaries and spleen.

16. The method of claim 11 wherein the wound is present in muscle tissue.

17. The method of claim 1 wherein the heated sealant material is applied to at least one of the ends of first and second vessels, the method further comprising pressing the ends of the first vessel to the second vessel to bond the vessels to each other.

18. The method of claim 1 wherein the heated sealant material is applied to a hole in a vessel.

19. The method of claim 1 wherein the heated sealant material is applied between a skin graft and muscle tissue.

20. The method of claim 1 wherein the heated sealant material is applied onto a fallopian tube to reconstruct said tube.

21. A method for closing a wound in tissue comprising:

housing a supply of sealant material within a reservoir of an applicator having a shaft with distal and proximal ends;

heating the sealant material;

sensing a temperature of the sealant material during the heating step;

positioning the distal end of the applicator shaft adjacent the wound;

discharging the sealant material through the distal end of the applicator shaft to apply the sealant material to the wound; and

allowing the sealant material to cool and set at the wound.

22. The method of claim 21 further including the step of introducing the distal end of the applicator shaft through a percutaneous penetration in the patient to or near a surgical incision or puncture in an internal body organ.

23. The method of claim 21 wherein the sealant material is heated by extruding the sealant material through a heated lumen near the distal end of the applicator shaft.

24. The method of claim 21 further including loading a solidified sealant plug into the introducer shaft, melting the sealant plug and discharging the melted sealant plug through the distal end of the introducer shaft.

25. The method of claim 21 further including loading a volume of sealant material into a reservoir within the applicator, the discharging step including discharging a portion of the volume of sealant material through the distal end of the applicator shaft.

26. The method of claim 21 wherein the sealant material is heated to a temperature sufficient to melt the sealant material.

27. The method of claim 21 wherein the discharging step includes extruding the melted sealant material onto the wound.

28. The method of claim 21 wherein the sealant material is heated to a temperature sufficient to denature surface proteins on the tissue when the sealant material is applied to the wound.

29. The method of claim 21 wherein the sealant material is heated to a temperature greater than 60°

C.

30. The method of claim 21 wherein the sealant material is heated to a temperature from 70°

C. to 110°

C.

31. The method of claim 21 wherein the sealant material comprises at least one of a biologic polymer and a synthetic organic polymer.

32. The method of claim 31 wherein the sealant material comprises a protein selected from the group consisting of collagen, fibrin, fibrogen, elastin, serum albumin, fibronectin, hemoglobin, ovalbumin and combinations thereof.

33. The method of claim 31 wherein the sealant material is a synthetic organic polymer selected from the group consisting of lactic acid, glycolic acid, hydroxybutyrate, phosphazine, polyester, polyethylene glycol, polyethylene oxide, polyacrylamide, polyhydroxyethylmethacrylate, poly-vinylpyrrolidon, poly-vinyl-alcohol, polyacrylic acid, polylactate, polycaprolactone, polypropylene, nylon and combinations thereof.

34. The method of claim 31 wherein the sealant material is present at from 25% to 75% by weight in a liquid carrier.

35. The method of claim 34 wherein the sealant material comprises fibrous collagen.

36. The method of claim 34 wherein the sealant material comprises gelatin.

37. The method of claim 21 further comprising the step of applying thermal energy to the sealant material after the discharging step and before the allowing step to facilitate bonding between the sealant material and surface proteins on the tissue surrounding the wound.

38. The method of claim 37 wherein the applying thermal energy step includes applying RF energy from an external probe.

39. The method of claim 37 wherein the applying thermal energy step includes applying energy from the group consisting of electrical energy, heat energy, laser energy and ultrasonic energy.

40. A method for closing a wound in tissue comprising:

housing a supply of sealant material within a reservoir of an applicator having a shaft with distal and proximal ends;

heating the sealant material;

positioning the distal end of the applicator shaft adjacent the wound;

discharging the sealant material through the distal end of the applicator shaft to apply the sealant material to the wound;

applying thermal energy to the sealant material after the discharging step to facilitate bonding between the sealant material and surface proteins on the tissue surrounding the wound; and

allowing the sealant material to cool and set at the wound.

41. The method of claim 40 further including the step of introducing the distal end of the applicator shaft through a percutaneous penetration in the patient to or near a surgical incision or puncture in an internal body organ.

42. The method of claim 40 wherein the sealant material is heated by extruding the sealant material through a heated lumen near the distal end of the applicator shaft.

43. The method of claim 40 further including loading a solidified sealant plug into the introducer shaft, melting the sealant plug and discharging the melted sealant plug through the distal end of the introducer shaft.

44. The method of claim 40 further including loading a volume of sealant material into a reservoir within the applicator, the discharging step including discharging a portion of the volume of sealant material through the distal end of the applicator shaft.

45. The method of claim 40 further including sensing a temperature of the sealant material during the heating step.

46. The method of claim 40 wherein the sealant material is heated to a temperature sufficient to melt the sealant material.

47. The method of claim 40 wherein the discharging step includes extruding the melted sealant material onto the wound.

48. The method of claim 40 wherein the sealant material is heated to a temperature sufficient to denature surface proteins on the tissue when the sealant material is applied to the wound.

49. The method of claim 40 wherein the sealant material is heated to a temperature greater than 60°

C.

50. The method of claim 40 wherein the sealant material is heated to a temperature from 70°

C. to 110°

C.

51. The method of claim 40 wherein the sealant material comprises at least one of a biologic polymer and a synthetic organic polymer.

52. The method of claim 51 wherein the sealant material comprises a protein selected from the group consisting of collagen, fibrin, fibrogen, elastin, serum albumin, fibronectin, hemoglobin, ovalbumin and combinations thereof.

53. The method of claim 51 wherein the sealant material is a synthetic organic polymer selected from the group consisting of lactic acid, glycolic acid, hydroxybutyrate, phosphazine, polyester, polyethylene glycol, polyethylene oxide, polyacrylamide, polyhydroxyethylmethacrylate, poly-vinylpyrrolidon, poly-vinyl-alcohol, polyacrylic acid, polylactate, polycaprolactone, polypropylene, nylon and combinations thereof.

54. The method of claim 51 wherein the sealant material is present at from 25% to 75% by weight in a liquid carrier.

55. The method of claim 54 wherein the sealant material comprises fibrous collagen.

56. The method of claim 54 wherein the sealant material comprises gelatin.

57. The method of claim 47 wherein the applying thermal energy step includes applying RF energy from an external probe.

58. The method of claim 47 wherein the applying thermal energy step includes applying energy from the group consisting of electrical energy, heat energy, laser energy and ultrasonic energy.