Assembly for sealing a puncture in a vessel

• US 5,649,959 A
• Filed: 02/10/1995
• Issued: 07/22/1997
• Est. Priority Date: 02/10/1995
• Status: Expired due to Term

• Current Assignee: Sherwood Medical Company (Medtronic Plc)
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: Hannam, Peter Henry, Allison, Richard Dale
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/389,839
• Time in Patent Office: 893 Days
• Field of Search: 606/213, 606/214, 606/1, 604/164, 604/170, 604/181, 604/257, 604/275, 604/39, 604/43, 604/40, 604/36, 604/92, 604/81, 604/93
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening

Abstract

A bioabsorbable assembly for sealing an incision or puncture in the body of the patient including a first member which is positioned generally along the wall of the blood vessel, duct, body cavity or lumen of the patient and a gelatinous material which is injected into the incision or puncture around a filament or clip member which is associated with the first member to seal the incision or puncture from the flow of fluids through the blood vessel, duct or lumen of the patient and the method therefore.

Claims

1. An assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel, duct, lumen or body cavity of the patient, the assembly comprising;

a first member formed of a bioabsorbable material and sized to be positioned in the blood vessel, duct or lumen of the patient;

a second member formed of a bioabsorbable and injectable liquid hemostasis promoting material and said second member is formed to cooperatively seal the incision from the flow of fluids therethrough in combination with said first member; and

a third member extending proximally from said first member and having greater flexibility than said first member.

2. The assembly of claim 1 wherein said second member is formed of an injectable hemostasis promoting material which is injectable along said third member and is absorbable within the body of the patient.

3. The assembly of claim 1 further including said third member extending from said first member and through at least a portion of said second member.

4. The assembly of claim 1 wherein said third member is a filament member and said third member is frictionally engaged with at least one of said first member or said second member.

5. The assembly of claim 1 wherein said third member is a flexible filament member which extends substantially through said second member.

6. The assembly of claim 1 wherein said third member is at least partially encircled by said second member.

7. The assembly of claim 1 wherein said first member is an anchor member.

8. The assembly of claim 1 wherein said second member is formed of a tissue glue which is injected into the incision in the body of the patient.

9. The assembly of claim 1 wherein said first member is sized to be operatively positionable in the blood vessel of a patient and said second member is operatively positionable in the incision in use and said third member extends between said first member and said second member such that said first member, said second member and said third member cooperatively seal the incision to obstruct the flow of blood from the blood vessel through the incision.

10. An assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel, duct, lumen or body cavity of the patient, the assembly comprising;

a first member formed of a bioabsorbable material and sized to be positioned in the blood vessel, duct or lumen of the patient;

a second member formed of a bioabsorbable and gelatinous hemostasis promoting material and said second member is formed to cooperatively seal the incision from the flow of fluids therethrough in combination with said first member;

a third member extending proximally from said first member and having greater flexibility than said first member; and

said second member is formed of a plurality of injectable materials which are mixed together to coagulate in the incision and seal the incision from the flow of fluids therethrough.

11. The assembly of claim 10 wherein said materials include a thrombin containing material therein.

12. The assembly of claim 10 wherein said materials include a fibrinogen containing material therein.

13. An assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel, duct or lumen of the patient, the assembly comprising;

a first member formed of a bioabsorbable material and sized to be positionable in the blood vessel, duct, body cavity or lumen of the patient;

a second member formed of a bioabsorbable and injectable liquid hemostasis promoting material and said second member is formed to cooperatively seal the incision from the flow of fluids therethrough in combination with said first member;

an insertion assembly including an elongate tubular member to facilitate the insertion of at least one of said first member or said second member into the incision; and

a third member sized to extend proximally from the first member and along the lengthwise dimension of the incision and said third member having greater flexibility than said first member.

14. The assembly of claim 13 wherein said tubular member is an elongate introducer member and said first member is expelled therefrom into the blood vessel, duct or lumen of the patient.

15. The assembly of claim 13 wherein said tubular member includes a means for ejection associated therewith and said second member is ejected therefrom.

16. The assembly of claim 13 wherein said tubular member includes an injection port thereon and said second member is injected therethrough.

17. An assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel, duct or lumen of the patient, the assembly comprising;

a first member formed of a bioabsorbable material and sized to be positionable in the blood vessel, duct, body cavity or lumen of the patient;

a second member formed of a bioabsorbable and gelatinous hemostasis promoting material and said second member for cooperatively sealing the incision from the flow of fluids therethrough in combination with said first member;

an insertion assembly including an elongate tubular member to facilitate the insertion of at least one of said first member or said second member into the incision; and

a syringe assembly having a plurality of chambers therein and said chambers include at least a portion of said second member therein.

18. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of a patient into a selected blood vessel of the patient, the method comprising;

inserting a first member through the incision to a location generally adjacent to the wall of the blood vessel and causing a third member which is more flexible than the first member to extend proximally from the first member into the incision; and

then injecting a gelatinous hemostasis promoting material into the incision such that the gelatinous material is positioned in the incision proximally of the first member and generally adjacent to the third member to seal the incision from the flow of blood passing through the blood vessel.

19. The method of claim 18 further including the step of ejecting the gelatinous material which includes a tissue glue from a syringe member into the incision.

20. The method of claim 18 further including the step of injecting a plurality of materials including thrombin and fibrinogen into the incision to form the gelatinous material.

21. The method of claim 18 further including the step of inserting the third member which is a filament member into the incision so that the filament member is frictionally engaged by the gelatinous material in the incision as the gelatinous material cures in the incision to cause the first member to be retained in the desired location generally adjacent to the wall of the blood vessel.

22. The method of claim 18 including the step of injecting the gelatinous material into the incision through a syringe.

23. The method of claim 22 further including the step of injecting the gelatinous material into the incision and along a filament member which is operatively connected to the first member.

24. The method of claim 23 further including the step of injecting the gelatinous material into the incision through the syringe which is movable into the incision along the filament member so that the gelatinous material cures in the incision to seal the incision from the flow of fluids therethrough.

25. The method of claim 18 further including the step of injecting a material containing thrombin therein as part of the gelatinous material in the incision through a syringe assembly which is inserted into the incision.

26. The method of claim 18 further including the step of injecting a material containing fibrin therein as part of the gelatinous material in the incision through a syringe assembly which is inserted into the incision.

27. The method of claim 18 further including the step of injecting separate materials containing thrombin and fibrin therein through a syringe assembly which is inserted into the incision and mixing the fibrin and thrombin in the incision to form the gelatinous material in the incision.

28. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of a patient into a selected blood vessel of the patient, the method comprising;

inserting a first member into the incision to a location generally adjacent to the wall of the blood vessel; and

injecting a gelatinous material into the incision using a syringe assembly such that the gelatinous material is positioned in the incision proximally of the first member to seal the incision from the flow of blood passing through the blood vessel by inserting the syringe assembly into the incision along a filament member to insert the distal end portion of the syringe assembly into the incision at a desired location and then ejecting the gelatinous material therefrom.