METHOD OF INHIBITING THE FORMATION OF ADHESIONS AND SCAR TISSUE AND REDUCING BLOOD LOSS

• US 20080069855A1
• Filed: 08/21/2007
• Published: 03/20/2008
• Est. Priority Date: 08/21/2006
• Status: Abandoned Application

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter
• Application Number:
  US11/842,648
• Publication Number:
  US 20080069855A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/8847 for removing cement from a bone cavity using surgical bone chisels, drills, mills, rasps, reamers or scrapers A61B17/16; using laser A61B18/20; using ultrasonic surgical instruments A61N7/00
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 35/24 Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid saliva A61K35/38
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61L 2400/04 : Materials for stopping bleeding
• CPC Class Codes: A61L 27/222 : Gelatin
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/045 : Gelatin
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides a method for inhibiting the formation of scar tissue and/or exogenous bone at a wound site in a body of a patient. The method includes administering an amount of a biologic agent to the wound site, wherein the biologic agent is synovial fluid or cerebrospinal fluid. A viscous substance applied to the wound site, advantageously incorporating the biologic agent, reduces the flow of blood from cut blood vessels, and contributes to a reduction in the formation of adhesions through action of the biologic agent, and through barrier properties introduced by the viscous substance.

Claims

1. A method of reducing blood loss from a circulatory system due to surgery, comprising the steps of:

cutting living tissue including blood vessels to access a surgical field, whereby the living tissue bleeds;

applying a biocompatible viscous substance, of between 25 and 2500 cP, to the bleeding tissue;

wherein the viscous substance adheres to the cut end portions of the cut blood vessels; and

wherein blood is impeded from leaving the cut ends of the cut blood vessels, resulting in less blood leaving the circulatory system, and less blood entering the surgical field.

2. The method of claim 1, further including the steps of:

damaging live tissue within the body;

applying a quantity of the viscous substance to the damaged tissue;

whereby the postoperative formation of adhesions associated with the damaged tissue is reduced.

3. The method of claim 2, further including, prior to the step of applying, the step of:

admixing into the viscous substance a therapeutic substance effective against the formation of adhesions;

whereby the therapeutic substance and the viscous substance each contribute to a reduction in the postoperative formation of adhesions.

4. The method of claim 3, wherein said therapeutic substance is selected from the group consisting of:

synovial fluid, cerebrospinal fluid, hyaluronic acid

5. The method of claim 1, further including the step of:

conducting at least a portion of the surgery within the viscous substance.

6. The method of claim 1, further including the step of:

substantially removing the viscous substance from a portion of the surgical field.

7. The method of claim 1, wherein after the step of cutting, further including the steps of:

inserting a tube through the cut tissue, into the body; and

wherein the step of applying further includes passing the viscous substance through the tube.

8. The method of claim 1, further including the step of cooling the cut living tissue to cause vasoconstriction.

9. The method of claim 8, wherein the step of cooling includes spraying the cut living tissue with a cool substance.

10. The method of claim 8, wherein cooling is carried out by a member of the group consisting of:

a cooled tourniquet, a cooled surgical tool, a cooled object implanted into the surgical field,

11. The method of claim 8, wherein the step of cooling is carried out before the step of applying.

12. The method of claim 1, further including, after the step of applying, the step of:

hardening said viscous substance.

13. The method of claim 1, wherein said viscous substance is selected from the group consisting of:

gelatin, gel polymer, biocompatible lubricant, water based lubricant, silicone based lubricant.

14. The method of claim 12, wherein said viscous substance includes gelatin, and wherein the gelatin hardens when cooled.

15. The method of claim 12, wherein said viscous substance includes a gel polymer, and wherein the gel polymer hardens when heated.

16. The method of claim 2, wherein said viscous substance is applied to an implant, wherein the implant remains inside the body after surgery.

17. The method of claim 1, further including, prior to the step of applying, the step of:

admixing into the viscous substance a substance operative to reduce bleeding selected from the group consisting of;

calcium, thrombin, cyanoacrylate.

18. The method of claim 1, further including the steps of:

inserting a balloon within the surgical field, wherein at least a part of the balloon presses against the cut tissue with a force greater than the blood pressure in the cut blood vessels.

19. The method of claim 18, further including, prior to the step of inserting, the step of:

coating a balloon with a viscous substance of between 25 and 2500 cP;

whereby the coated balloon is inserted in the step of inserting.

20. The method of claim 19, further including the steps of:

hardening the coating of viscous substance;

cutting away portions of said balloon, wherein a portion of the balloon remains pressed against the cut tissue, and an additional area of the surgical field is exposed.

21. The method of claim 20, wherein hardening the coating of viscous substance includes the step of changing the temperature of the coating.

22. The method of claim 18, wherein said steps of coating and inserting are repeated, whereby a plurality of coated balloons is inserted.

23. The method of claim 18, further including, after the step of inserting, the step of:

expanding the balloon to push body tissue, whereby the size of the surgical field is increased.

24. A device for reducing blood loss during surgery due to cut blood vessels in a surgical field, comprising:

a balloon fabricated from an elastomeric polymer;

a valve;

means integral with said balloon for lowering the temperature of the surface of said balloon;

whereby said balloon is inserted into the surgical field and pressed against the cut blood vessels, applying pressure to the cut blood vessels, and cooling the blood vessels to induce vasoconstriction, thereby reducing blood flow from the cut blood vessels.

25. The device of claim 24, wherein said means integral with said balloon for lowering the temperature of the surface of said balloon comprise:

an inlet,

an outlet,

an elongated channel connected at a first end to said inlet and at a second end to said outlet, operative to conduct a cooled flowable material from said inlet to said outlet.

26. The device of claim 24, wherein said means integral with said balloon for lowering the temperature of the surface of said balloon comprise:

a first chemical;

a chamber;

a second chemical operative to produce an endothermic reaction when mixed with said first chemical, disposed within said chamber;

whereby when said first chemical and said chamber are disposed within said balloon, and when said chamber is squeezed sufficiently to be ruptured, mixing of said first chemical with said second chemical takes place, resulting in an endothermic reaction, whereby the temperature of said balloon is lowered.

27. The device of claim 24, further including:

a coating of a viscous substance of between 25 and 2500 cP, disposed about at least a portion of an outer surface of said balloon, operative to surround the cut ends of cut blood vessels when said balloon is inserted into the surgical field and pressed against the cut blood vessels, wherein blood is thereby impeded from leaving the cut ends of the cut blood vessels, resulting in less blood leaving the circulatory system, and less blood entering the surgical field.

28. The device of claim 27, wherein said viscous substance is gelatin, and wherein said gelatin is hardened when the temperature of the surface of said balloon is lowered.

29. The device of claim 27, wherein said viscous substance is a gel polymer.

30. The device of claim 29, wherein said gel polymer is hardened by the application of heat.

31. The device of claim 29, wherein said gel polymer is hardened by the application of ultraviolet radiation.

32. The device of claim 30, further comprising:

a metallic element associated with said balloon, operative to heat an outer surface of said balloon upon exposure to radio frequency radiation, whereby said gel polymer is hardened.

33. A surgically implanted device comprising:

an implant body;

a metallic element associated with said implant body, operative to produce heat when exposed to radio frequency radiation through the skin;

whereby the device produces comfort or therapeutic benefit through the generation of heat.

34. The surgically implanted device of claim 33, further comprising:

a coating of a viscous substance of between 25 and 2500 cP, disposed about at least a portion of an outer surface of said implant body, containing a therapeutic substance operative to reduce the formation of adhesions associated with the implanted device.

35. A surgically implanted device comprising

an implant body;

means integral with said device for lowering the temperature of the device;

whereby said device is inserted into the surgical field and pressed against the cut blood vessels, applying pressure to the cut blood vessels, and cooling the blood vessels to induce vasoconstriction, thereby reducing blood flow from the cut blood vessels.

36. The device of claim 35, wherein said means integral with said device for lowering the temperature of the device comprise:

an inlet,

an outlet,

an elongated channel connected at a first end to said inlet and at a second end to said outlets operative to conduct a cooled flowable material from said inlet to said outlet.

37. A surgically implanted device comprising:

an implant body;

a coating of a viscous substance of between 25 and 2500 cP, disposed about at least a portion of an outer surface of said implant body, containing a therapeutic substance operative to reduce the formation of adhesions associated with the implanted device.

38. The device of claim 37, wherein said implant body is selected from the group consisting of:

spinal implant, intramedullary rod, joint replacement component.

39. The method of claim 2, further including the steps of:

coating an implant with a viscous substance of between 25 and 2500 cP;

placing the implant within the surgical field;

leaving the implant within the surgical field at the conclusion of the surgery;

wherein the coating reduces the postoperative formation of adhesions connected to the implant.

40. The method of claim 39, further including the steps of:

applying a covering coating with a viscous substance of between 25 and 2500 cP to body tissue adjacent to the implant placed within the surgical field;

wherein the covering coating is operative to further reduce the postoperative formation of adhesions adjacent to the implant.

41. A tourniquet for reducing blood flow in a limb of a body, comprising:

a cuff, operative to surround at least a portion of the limb, including

an inlet,

an outlet,

an elongated channel connected at a first end to said inlet and at a second end to said outlet, operative to conduct a flowable material from said inlet to said outlet, and

means for applying pressure to the limb;

whereby said flowable material is cooled before it is passed through said channel, and

whereby vasoconstriction is accomplished by applying pressure using said means for applying pressure and by cooling of blood flowing in the limb through the tourniquet.

42. A metal surgical tool for cooling body tissue, comprising:

means for contacting body tissue;

a handle having a first end proximate said means for contacting body tissue, and a second end distal from said means for contacting body tissue;

an elongated channel extending between said first end and said second end including an inlet and an outlet;

means for connecting said inlet to a source of flowable material having a temperature lower than the body tissue contacted;

whereby the cold flowable material reduces the temperature of the tool, and the tool thereby reduces the temperature of the contacted tissue.

43. A method of performing surgery comprising the step of:

applying cement to body tissue during the surgery;

applying a viscous substance of between 25 and 2500 cP adjacent to the area of cement application, whereby cement misplaced adjacent to the area of cement application hardens on top of the viscous substance, and not in bonded conformity to body tissue;

whereby removal of the misplaced cement is facilitated.

44. The method of claim 1, further comprising the step of:

applying a dressing formed as a coating of viscous substance of between 25 and 2500 cP to the surgical wound closure,

hardening said dressing.

45. A method of inhibiting the formation of scar tissue in a wound site in a body of a patient, comprising:

administering an amount of a biologic agent to the wound site, wherein the biologic agent includes a therapeutic agent selected from the group consisting of;

synovial fluid, cerebrospinal fluid, and hyaluronic acid.

46. The method of claim 45, further comprising administering an amount of the biologic agent to an object selected from the group consisting of:

medical implant positioned in the wound, biodegradable implant positioned in the wound, implant positioned in the wound comprising a plurality of layers each containing the biologic agent.

47. (canceled)

48. The method of claim 47, further comprising administering an amount of the biologic agent to an area selected from the group consisting of:

adjacent to the wound, between two bones of a joint, between two vertebrae.

49-53. -53. (canceled)

54. The method of claim 45, wherein the biologic agent includes a medicinal agent.

55. A method of inhibiting the formation of exogenous bone around a joint in a body of a patient, comprising:

administering an amount of a biologic agent to the joint, wherein the biologic agent includes a therapeutic agent selected from the group consisting of;

synovial fluid, cerebrospinal fluid, and hyaluronic acid.

56. (canceled)

57. The method of claim 55, wherein administering an amount of a biologic agent to an object selected from the group consisting of:

medical implant positioned in the joint, biodegradable implant positioned in the joint, implant positioned in the joint comprising a plurality of layers each containing the biologic agent.

58. The method of claim 55, further comprising administering an amount of the biologic agent to an area selected from the group consisting of:

between two bones of a joint, between two vertebrae.

59-63. -63. (canceled)

64. The method of claim 55, wherein the biologic agent includes a medicinal agent.