Device for sealing hemostatic incisions

• US 5,540,715 A
• Filed: 02/01/1995
• Issued: 07/30/1996
• Est. Priority Date: 07/16/1992
• Status: Expired due to Term

• Current Assignee: Sherwood Medical Company (Medtronic Plc)
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: Thomas, David G., Allison, Richard D., Katsaros, Georges
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/381,805
• Time in Patent Office: 545 Days
• Field of Search: 606/213, 606/215, 606/216, 606/151, 606/195, 606/108, 606/94, 606/77, 606/1, 623/1, 623/11, 604/93, 604/96, 604/181, 604/208, 604/265, 604/101, 128/899
• US Class Current: 606/213
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004

Abstract

A device for sealing incisions in the body of a patient wherein the device includes a bioabsorbable sealing member having an elongate shaft member and an elastomeric and flexible balloon member. The device may also include a preformed or injectable collagenous material associated therewith to hemostatically seal the incision in the body of the patient. The shaft member may include one or more lumens extending therethrough in flow communication with one or more balloon members thereon to provide a relatively simple device which effectively seals an incision in the body of a patient.

Claims

1. A method of sealing an incision or puncture in the body of a patient, the method comprising:

providing a sealing member formed of a bioabsorbable material which is absorbable within the body of a patient after a period of time sufficient for permitting effective closure of the incision;

inserting the sealing means into the incision such that the distal end of the sealing means extends a short distance beyond the incision;

causing the expansion of a portion of the sealing means;

withdrawing the sealing means in the incision until the expanded portion of the sealing means contacts a predetermined portion of the incision to prevent the flow of fluids through the incision;

injecting a fluid having hemostasis promoting material therein into the incision along a portion of the sealing member to assist in the retention of the sealing member in the incision; and

leaving the sealing member in a predetermined position in the incision to be absorbed within the body of the patient.

2. The method of claim 1 wherein the sealing member is provided with at least one lumen therein and a fluid is injected through the lumen in the sealing member to cause the expansion of a portion of the sealing member.

3. The method of claim 2 wherein the sealing member is provided with a further lumen therein and the fluid containing the hemostasis promoting material is injected therethrough to a location along the exterior of a portion of the sealing member.

4. The method of claim 1 wherein the sealing member is provided with a shaft portion and an expandable portion and the shaft portion is positioned in the incision to extend between the skin of the patient and the blood vessel.

5. The method of claim 4 wherein the expandable portion of the sealing member is positioned adjacent to the blood vessel as the sealing member is withdrawn in the incision.

6. A device for sealing an incision in the body of a patient wherein the incision extends between the skin of the patient and a blood vessel, the assembly comprising;

a bioabsorbable first element which is sized to be positioned generally adjacent to the incision in the blood vessel;

a bioabsorbable retaining element operatively connected to said first element and extending proximally of said element in the incision in use; and

a fluid including a bioabsorbable and injectable hemostasis promoting material therein which is injected into the incision and wherein said hemostasis promoting material and said retaining element are in cooperative engagement to seal the incision from the flow of blood passing through the blood vessel.

7. The device of claim 6 wherein said first element is sized to be received through the incision in a first orientation thereof and is sized to resist passage through the incision in a second orientation thereof.

8. The device of claim 7 wherein said first element is inflated in said second orientation.

9. The device of claim 7 wherein said first element is oriented generally parallel to said retaining element during the insertion of said first element into the incision.

10. The device of claim 7 wherein said first element is oriented generally perpendicular to said retaining element when the incision is sealed from the flow of blood passing through the blood vessel.

11. The device of claim 6 wherein at least the portion of said retaining element between said first element and said hemostasis promoting material extends across the wall of the blood vessel in use.

12. The device of claim 6 wherein said hemostasis promoting material frictionally engages said retaining element in use.

13. The device of claim 6 wherein said hemostasis promoting material and said first element are in a spaced apart relationship along said retaining element in use.

14. A bioabsorbable assembly for sealing openings in the wall of a blood vessel comprising;

a first element which is sized to be fitted through the wall of the blood vessel and lie generally adjacent thereto in use;

a shaft element sized to be received in the incision and in operative connection with said first element to extend proximally thereof in the incision; and

an injectable hemostasis promoting material which is injected into the incision in a fluid state to cooperatively engage said shaft element and seal the incision from the flow of blood passing through the blood vessel.

15. The assembly of claim 14 wherein said hemostasis promoting material is injectable through at least a portion of said shaft element.

16. The assembly of claim 14 wherein said first member is movable between a first orientation with respect to said shaft element during insertion and a second orientation with respect to said shaft element in use.

17. The assembly of claim 16 further including an injectable fluid which is injectable into said first member to cause said first member to move from said first orientation to said second orientation.

18. A device for sealing an incision in the body of a patient wherein the incision extends between the skin of the patient and a blood vessel, the assembly comprising;

a bioabsorbable first element which is sized to be positioned generally adjacent the incision in the blood vessel;

a bioabsorbable retaining element operatively connected to said first element and extending proximally of said first element in the incision in use; and

a bioabsorbable second element sized to be received in the incision and wherein said first element and said second element are cooperatively connected to said retaining element and at least one of said first element and said second element includes an injectable fluid associated therewith to seal the incision from the flow of blood passing through the blood vessel.

19. The assembly of claim 18 wherein said injectable fluid includes a hemostasis promoting material which is injectable along at least a portion of said shaft element to a position proximally of the wall of the blood vessel to seal the incision from the flow of blood passing through the blood vessel.

20. The assembly of claim 18 wherein said injectable fluid is injected into said first member to cause said first member to expand in response thereto.

21. A method of inserting a sealing device into an incision to seal an incision that extends between the skin of a patient and a blood vessel, the method including;

inserting a bioabsorbable assembly having a first element and a retaining element into the incision and blood vessel; and

injecting a fluid material which includes a bioabsorbable hemostasis promoting material therein along the retaining element to a position in the incision wherein the hemostasis promoting material is spaced apart from the first element to seal the incision from the flow of blood through the blood vessel.

22. The method of claim 21 including the step of positioning the first element along the wall of the blood vessel generally adjacent to the incision.

23. The method of claim 21 further including the step of positioning the hemostasis promoting material in a predetermined relationship proximally of the first element and along the retaining element in use to seal the incision from the flow of blood through the blood vessel.

24. The method of claim 21 further including the step of causing the expansion of the first element after insertion so that the expanded first element is positioned generally along the distal surface of the wall of the blood vessel in use.

25. The method of claim 21 further including the step of injecting the fluid including the hemostasis promoting material into the incision along at least a portion of the retaining element to securely hold the first element along the wall of the blood vessel such that at least a portion of the retaining element is positioned between the hemostasis promoting material and the first element along the wall of the blood vessel.

26. The method of claim 21 further including the step of causing the radial expansion of a second element after insertion of the assembly into the incision so that the first element is oriented generally along the distal surface of the wall of the blood vessel in use and the second element is spaced apart therefrom proximally along the retaining element.

27. A method of sealing an incision in the body of the patient wherein the incision extends between the skin of the patient and a blood vessel, duct or lumen, the method comprising;

positioning a bioabsorbable element in the incision between the skin of the patient and the blood vessel, duct or lumen such that a portion thereof extends into the blood vessel, duct or lumen to obstruct the flow of fluid through the incision from the blood vessel, duct or lumen of the patient; and

injecting a fluid including a bioabsorbable hemostasis promoting material into the incision along a portion of the bioabsorbable element.

28. The method of claim 27 further including the step of positioning a portion of the bioabsorbable element in the blood vessel, duct or lumen generally adjacent to the incision such that the bioabsorbable element and the hemostasis promoting material cooperatively obstruct the flow of fluid through the incision from the blood vessel, duct or lumen.

29. The method of claim 27 further including the step of causing the radial expansion of at least a portion of the bioabsorbable element in the blood vessel, duct or lumen to obstruct the flow of fluid through the incision from the blood vessel, duct or lumen.

30. The method of claim 29 further including the step of causing the radial expansion of a further portion of the bioabsorbable element in the incision to obstruct the flow of fluid through the incision from the blood vessel, duct or lumen.

31. A method of sealing an incision in the body of the patient wherein the incision extends between the skin of the patient and a blood vessel, duct or lumen, the method comprising;

positioning a bioabsorbable element in the incision between the skin of the patient and the blood vessel, duct or lumen in a predetermined location such that a portion thereof extends into the blood vessel, duct or lumen to obstruct the flow of fluid through the incision from the blood vessel, duct or lumen of the patient; and

causing the radial expansion of first and second balloon members on the bioabsorbable element such that upon positioning of the bioabsorbable element in the predetermined location, the wall of the blood vessel, duct or lumen is sandwiched between the radially expanded first and second balloon members.

32. The method of claim 31 further including the step of injecting a bioabsorbable hemostasis promoting material as a fluid material into the incision along a portion of the bioabsorbable element to seal the incision from the flow of fluid through the blood vessel, duct or lumen.

33. The method of claim 31 further including the step of sliding a third element into the incision along a portion of the bioabsorbable element.

34. The method of claim 31 further including the steps of inflating the first and second elements to cause the radial expansion thereof.

35. The method of claim 31 further including the step of injecting a fluid into the incision as a third element along the bioabsorbable element.