Hemostasis apparatus and method

• US 5,186,711 A
• Filed: 05/28/1991
• Issued: 02/16/1993
• Est. Priority Date: 03/07/1989
• Status: Expired due to Fees

• Current Assignee: Albert Einstein College of Medicine of Yeshiva University
• Original Assignee: Albert Einstein College of Medicine of Yeshiva University
• Inventors: Epstein, Adam
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/708,101
• Time in Patent Office: 630 Days
• Field of Search: 606/202, 606/203, 606/151, 128/87 R, 623/12, 623/13, 623/16, 623/16 A
• US Class Current: 600/37
• 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 2090/0815 Implantable devices for insertion in between organs or other soft tissues
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

A kit for effecting hemostatis of an organ comprises a mesh and a sack. The mesh is formed of semirigid, bioabsorbable material adapted to be generally conformingly disposed on at least the bleeding surface of an organ. The sack is made of flexible, elastic, air-impermeable material adapted to be elastically stretched over the mesh and over a substantial portion of the organ and then released to compress the organ portion and thereby decrease the flow of blood thereto. The sack further permits operative attachment of the undersurface thereof to a vacuum source so that portions of the organ may be pulled outwardly by the vacuum into the interstices of the underlying mesh to promote hemostasis.

Claims

1. A device for effecting hemostasis of an organ comprising:

(A) an air-permeable mesh of semirigid bioabsorbable material defining interstices and adapted to be generally conformingly disposed on at least the bleeding surface of an organ; and

(B) a sack defining a continuous surface made of flexible, elastic, resilient air-impermeable material and an opening at one portion thereof adapted to enable passage of the bleeding surface of the organ therethrough, said elastic material being configured and dimensioned to be elastically stretched over said mesh and over a substantial portion of the organ and upon release to compress the organ portion and thereby decrease the flow of blood thereto;

said sack further including means for operative attachment of the undersurface thereof to a vacuum source so that portions of the organ may be pulled outwardly by the vacuum into the interstices of said underlying mesh to promote hemostasis.

2. The device of claim 1 wherein said sack is adapted to be generally conformingly disposed on at least the bleeding surface of a spleen.

3. The device of claim 1 wherein said sack upon release effects an at least partially operative seal with the organ about the bleeding surface thereof to at least decrease the flow of blood thereto.

4. The device of claim 1 wherein said sack is made of bioabsorbable material.

5. The device of claim 1 wherein said sack is made of non-bioabsorbable material.

7. The device of claim 1 wherein said sack is made of an elastic material which is sufficiently elastic to reduce the size of the organ portion and thereby create a back pressure reducing or terminating blood flow thereinto and to generally conform said mesh to the outer surface of the organ portion.

8. The device of claim 1 wherein said mesh is made of a semirigid material which is sufficiently rigid to preclude deformation under the vacuum created by the vacuum source but sufficiently flexible to be substantially conformed over the bleeding surface of the organ by said sack.

9. The device of claim 1 wherein said mesh contains a plurality of interlocked layers, at least some of the interstices of one layer of said mesh being partially offset from the interstices of an adjacent layer of said mesh, whereby some portions of the organ pulled outwardly by the vacuum into the interstices of said mesh are also pulled at an angle to the thickness of said mesh, thereby to promote joinder of some adjacent portions.

10. The device of claim 1 wherein said mesh is a rice point knit.

11. The device of claim 1 wherein said mesh is substantially coextensive with said sack.

12. The device of claim 11 wherein said sack and said mesh are both bioabsorbable and joined together as outer and inner layers, respectively, of a composite sack/mesh, whereby said composite sack/mesh may be applied as a unit to the organ.

13. The device of claim 1 wherein said sack is disposed directly over said mesh without any intervening material therebetween.

6. The device of claim wherein said sack is sufficiently resilient to be elastically stretched and then released to conform said mesh to the bleeding surface of the organ.

14. A method of effecting hemostasis of an organ comprising the steps of:

(A) applying an air-permeable mesh of semirigid bioabsorbable material defining interstices to at least the bleeding surface of an organ in generally conformingly disposition;

(B) elastically stretching a sack made of flexible, elastic resilient, air-impermeable material over the mesh and over a substantial portion of the organ and then releasing the sack to compress the organ portion and thereby decrease the flow of blood thereto; and

(C) applying a vacuum to the undersurface of the sack to pull portions of the organ into the interstices of the underlying mesh to promote hemostasis.

15. The method of claim 14 wherein the sack is applied to the bleeding surface of a spleen.

16. The method of claim 14 wherein the sack is applied over the substantial organ portion so that upon release it effects an at least partially operative seal with the organ about the bleeding surface thereof to at least decrease the flow of blood thereto.

17. The method of claim 14 wherein the sack is made of bioabsorbable material.

18. The method of claim 14 wherein the sack is made of non bioabsorbable material.

19. The method of claim 14 wherein upon release the sack conforms the mesh to the bleeding surface of the organ.

20. The method of claim 14 wherein the sack is made of an elastic material which is sufficiently resilient to reduce the size of the organ and thereby create a back pressure reducing or terminating blood flow thereinto and to generally conform said mesh to the outer surface of the organ.

21. The method of claim 14 wherein the mesh is made of a semirigid material which is sufficiently rigid to preclude deformation under the vacuum created under the sack but sufficiently flexible to be substantially conformed over the bleeding surface of the organ by the sack.

22. The method of claim 14 wherein the mesh contains a plurality of layers, at least some of the interstices of one layer of said mesh being partially offset from the interstices of an adjacent layer of said mesh, whereby some portions of the organ pulled outwardly by the vacuum into the interstices of the mesh are also pulled at an angle to the thickness of said mesh, thereby to promote joinder of some adjacent portions.

23. The method of claim 14 wherein the mesh is a rice point knit.

24. The method of claim 14 wherein the mesh is substantially coextensive with the sack.

25. The method of claim 24 wherein the sack and the mesh are both bioabsorbable and joined together as outer and inner layers, respectively, of a composite sack/mesh so that the mesh and sack are applied together as a unit to the organ.

26. In combination, to effect hemostasis of the bleeding surface of an organ:

(A) an air-permeable mesh of semirigid bioabsorbable material defining interstices and conformingly disposed on at least the bleeding surface of the organ; and

(B) a sack defining a continuous surface made of flexible, elastic, resilient air-impermeable material and an opening at one portion thereof, said elastic material being disposed over said mesh and over a substantial portion of the organ to compress the organ portion and thereby decrease the flow of blood thereto;

(C) a vacuum source; and

(D) means operatively attaching said vacuum source and said sack so that portions of the organ are pulled outwardly by the vacuum into the interstices of said underlying mesh to promote hemostasis.

27. The combination of claim 26 wherein said sack is made of bioabsorbable material, and said vacuum source is disposed outside of the body containing the organ, said combination additionally including means for releasably securing said attaching means and said sack, said releasable securing means being releasable from outside the body.

28. The device of claim 27 wherein said sack and said mesh are both bioabsorbable and joined together as outer and inner layers, respectively, of a composite sack/mesh, whereby said composite sack/mesh may be applied as a unit to the organ.

29. The combination of claim 26 wherein said sack is disposed directly over said mesh without any intervening material therebetween.

30. A device for effecting hemostasis of a spleen comprising:

(A) an air-permeable mesh of semirigid bioabsorbable material defining interstices and adapted to be generally conformingly disposed on at least the bleeding surface of an organ, said mesh containing a plurality of interlocked layers, at least some of the interstices of one layer of said mesh being partially offset from the interstices of an adjacent layer of said mesh, whereby some portions of the organ pulled outwardly by a vacuum into the interstices of said mesh are also pulled at an angle to the thickness of said mesh, thereby to promote joinder of some adjacent portions; and

(B) a sack defining a continuous surface made of flexible, elastic, resilient air-impermeable material and an opening at one portion thereof, said elastic material being configured and dimensioned to be elastically stretched over said mesh and over a substantial portion of the organ and upon release to conform said mesh to the bleeding surface of the organ and to compress the organ portion, thereby decreasing the flow of blood thereto, said elastic material being sufficiently elastic to reduce the size of the organ portion and thereby create a back pressure reducing or terminating blood flow thereinto and to generally conform said mesh to the outer surface of the organ portion, said sack further including means for operative attachment of the undersurface thereof to a vacuum source so that portions of the organ may be pulled outwardly by the vacuum into the interstices of said underlying mesh to promote hemostasis;

said mesh being coextensive with said sack and made of a semirigid material sufficiently rigid to preclude deformation under the vacuum created by the vacuum source but sufficiently flexible to be substantially conformed over the bleeding surface of the organ by said sack.

31. A device for effecting hemostasis of an organ comprising:

(A) an air-permeable mesh of semirigid bioabsorbable material defining interstices generally conformingly disposed on at least the bleeding surface of an organ; and

(B) a sack defining a continuous surface made of flexible, elastic, resilient air-impermeable material and an opening at one portion thereof, said elastic material being elastically stretched over said mesh and over a substantial portion of the organ and compressing the organ portion, thereby decreasing the flow of blood thereto;

said sack further including means for operative attachment of the undersurface thereof to a vacuum source so that portions of the organ may be pulled outwardly by the vacuum into the interstices of said underlying mesh to promote hemostasis.