Insertion assembly and method of inserting a vessel plug into the body of a patient

• US 5,601,602 A
• Filed: 11/16/1994
• Issued: 02/11/1997
• Est. Priority Date: 10/01/1990
• Status: Expired due to Term

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Original Assignee: Quinton Instrument Co. (Cardica Incorporated)
• Inventors: Fowler, Bradford C.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/340,507
• Time in Patent Office: 818 Days
• Field of Search: 606/213, 606/215, 606/230, 604/15, 604/285-288
• 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
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/06 Blood vessels

Abstract

A device and method of closing an incision or puncture in a patient by inserting a vessel plug into the incision or puncture until the distal end of the vessel plug is adjacent to the outer lumen of the blood vessel or target organ so that the vessel plug does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the vessel plug in the incision or puncture is accomplished through the use of a balloon catheter or a cylindrical insertion assembly having a proximal plunger member associated therewith.

Claims

1. A closure device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a target organ or blood vessel of the patient, said closure device comprising:

an elongate vessel plug formed of a hemostasis promoting material and having distal and proximal portions and said vessel plug adapted to be received in the incision such that said distal portion is located at a first predetermined position in the incision adjacent to the outer surface of the target organ or blood vessel of the patient and said proximal portion is located at a second predetermined position adjacent to the outer skin surface of the patient and said vessel plug is positioned in the incision to obstruct the flow of fluids therethrough without extending into the target organ or blood vessel of the patient.

2. An insertion 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 of the patient, the insertion assembly comprising;

an elongate positioning member having an outer diameter and a length sufficient to extend between the skin of the patient and the blood vessel of the patient; and

a vessel plug adjacent to said positioning member and which is constructed of a material which is absorbable within the body of a patient and said vessel plug being sized to extend in the incision proximally of the blood vessel and adjacent to the outer diameter of said positioning member in use to seal the incision from the flow of blood passing through the blood vessel.

3. The insertion assembly of claim 2 wherein said vessel plug is formed of a hemostasis promoting material which is absorbable within the body of the patient.

4. The insertion assembly of claim 2 wherein said positioning member further includes an elongate passageway therein.

5. The insertion assembly of claim 4 wherein said positioning member includes distal and proximal end portions thereon and said passageway is in communication with a plunger member adjacent to said proximal end portion thereof.

6. The insertion assembly of claim 5 wherein said positioning member further includes a balloon member on the distal end portion thereof.

7. An insertion 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 of the patient, said insertion assembly comprising in combination;

a hemostasis promoting material which is constructed of a material which is absorbable in the body of a patient and which seals the incision from the flow of blood passing through the blood vessel; and

an elongate positioning member having a passageway therein and at least a portion of said positioning member has an outer diameter in use which is greater than the diameter of the incision to facilitate the positioning of said hemostasis promoting material at a predetermined position in the incision proximally of the blood vessel.

8. The insertion assembly of claim 7 wherein said hemostasis promoting material further includes a radio-opaque material therein.

9. The insertion assembly of claim 7 wherein said positioning member includes at least a portion thereof which is expandable to increase the diameter thereof in use.

10. The insertion assembly of claim 9 wherein said expandable portion of said positioning member is adjacent to said hemostasis promoting material when said hemostasis promoting material is in said predetermined position in the incision.

11. The insertion assembly of claim 7 wherein said hemostasis promoting material is received in said positioning member prior to use.

12. The insertion assembly of claim 11 wherein said positioning member includes a passageway therein which is sized to receive at least a portion of said hemostasis promoting material therein prior to use.

13. The insertion assembly of claim 11 wherein said positioning member includes a plunger member operatively associated therewith to move said hemostasis promoting material to said predetermined position in the incision.

14. The insertion assembly of claim 7 wherein said hemostasis promoting material is formed of a clotting agent.

15. The insertion assembly of claim 7 wherein said hemostasis promoting material is formed of a tissue thromboplastin.

16. An insertion assembly for sealing an incision in the body of a patient wherein the incision extends generally from the skin of the patient into a blood vessel of the patient, said insertion assembly comprising;

a vessel plug member formed of a material which is absorbable within the body of the patient wherein said vessel plug generally includes distal and proximal portions in use and wherein said distal portion is sized to be positioned generally adjacent to the blood vessel of the patient to seal the incision from the flow of blood passing through the blood vessel of the patient; and

a positioning member having distal and proximal end portions thereon and having an outer diameter and a length sufficient to extend between the skin of the patient and a location near the blood vessel in use and said vessel plug contacting at least a portion of said outer diameter of said positioning member to position said vessel plug in a predetermined position in the incision proximally of the blood vessel.

17. 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 positioning member into the incision wherein the positioning member includes at least a portion thereof which has a diameter greater than the diameter of the incision in use, and

inserting a hemostasis promoting material into the incision via a portion of the positioning member such that the hemostasis promoting material is positioned in the incision proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel.

18. The method of claim 17 further including the step of ejecting the hemostasis promoting material from the positioning member into the incision by depressing a plunger member on the positioning member.

19. The method of claim 18 further including the step of manually increasing the diameter of at least a portion of the positioning member prior to ejecting the hemostasis promoting material from the positioning member.

20. The method of claim 17 further including the step of inflating a balloon member on the positioning member to limit the movement of the hemostasis promoting material in the incision thereby preventing the hemostasis promoting material from being positioned in the blood vessel of the patient.

21. The method of claim 17 further including the step of inserting a radio-opaque material into the incision along with the hemostasis promoting material into the incision.

22. The method of claim 17 further including the step of depressing a plunger member on the positioning member to insert the hemostasis promoting material into the incision.

23. 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 positioning member into the incision wherein the positioning member includes an outer diameter and a lengthwise dimension at least a portion of which extends between the skin of the patient and the blood vessel; and

inserting a hemostasis promoting material into the incision along a portion of the positioning member such that the hemostasis promoting material is positioned in the incision proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel.

24. The method of claim 23 further including the step of positioning the hemostasis promoting material along the outer diameter of the positioning member in the incision.

25. The method of claim 24 further including the step of causing the hemostasis promoting material to contact the wall of the blood vessel as the hemostasis promoting material contacts the outer diameter of the positioning member.

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

providing an insertion assembly which includes a bioabsorbable vessel plug and an elongate positioning member;

advancing at least the positioning member into the incision such that at least a portion thereof extends between the skin of the patient and the blood vessel; and

positioning the vessel plug in the incision such that the vessel plug is generally adjacent to the outer surface of the positioning member.

27. The method of claim 26 wherein the vessel plug is positioned proximally of the blood vessel in the incision to obstruct the flow of blood from the blood vessel into the incision.

28. The method of claim 26 wherein the vessel plug is moved along at least a portion of the outer diameter of the positioning member as the vessel plug is positioned between the skin of the patient and the blood vessel.

29. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient through the lumen of a blood vessel and into the blood vessel of a patient, the method including the steps of:

forming a vessel plug of a material which is absorbable in the body of the patient and wherein the vessel plug is formed to include distal and proximal ends therein and is dimensioned to be received in the incision; and

positioning the vessel plug in a predetermined position in the incision such that the distal end of the vessel plug is located proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel without extending into the blood vessel.

30. The method of claim 29 further including the step of expelling the vessel plug from an elongate and generally tubular member having an open distal end which is dimensioned to allow the vessel plug to pass therethrough and into the incision such that the distal end of the vessel plug is positioned adjacent to and proximally of the blood vessel of the patient in the incision.

31. The method of claim 29 further including the step of identifying the location of the blood vessel adjacent to the incision to facilitate the placement of the distal end of the vessel plug proximally of the blood vessel.

32. The method of claim 31 further including the step of positioning the vessel plug in the incision according to the identified location of the blood vessel such that the flow of blood through the blood vessel is unobstructed by the vessel plug and obstructed in the incision.

33. The method of claim 29 further including the step of expanding location means on an insertion member to identify the location of the blood vessel adjacent to the incision.

34. The method of claim 29 further including the step of inflating a member on an insertion member to identify the location of the blood vessel adjacent to the incision.

35. The method of claim 29 further including the step of radially expanding a portion of an insertion member to identify the location of the blood vessel adjacent to the incision.

36. The assembly as defined in claim 35 wherein said vessel plug is a cylindrical rod shaped member constructed of a biodegradable material.

37. The assembly as defined in claim 35 further comprising a sheath introducer having a lumen extending longitudinally therethrough, said introducer dimensioned to receive said shaft member and said expandable member within said lumen.

38. An assembly for sealing or closing an incision or puncture in the body of a living patient wherein the incision or puncture extends into a blood vessel or an organ of the patient, the assembly comprising:

an elongate shaft member having a proximal end and a distal end and having an expandable member disposed at said distal end, said expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

said shaft member and said expandable member dimensioned to be inserted within the puncture so that said expandable member is positioned within a target organ or blood vessel of the patient;

control member operatively connected to said expandable member and associated with said shaft member for selectively positioning said expandable member between said expanded condition and said relaxed condition; and

a vessel plug operatively associated with said shaft member for insertion into the puncture, said expandable member configured to cooperate with said plug when said expandable member is in said expanded condition to prevent said vessel plug from entering the vessel or the organ of the patient, and said vessel plug, when sealingly positioned within the puncture, extends proximally of the target organ or blood vessel without extending into said vessel or said organ.

39. The assembly as defined in claim 38 wherein said elongate shaft member includes a lumen therein in communication with said expandable member.

40. An apparatus for sealing or closing an incision or puncture in the body of a living patient wherein the incision or puncture extends into a blood vessel or an organ of the patient, the apparatus comprising:

a tubular member having a proximal end and a distal end and having an expandable member disposed at said distal end of said catheter, said expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

said expandable member dimensioned to be positioned within a target organ or blood vessel of the patient and constructed to permit blood and other body fluids to pass through the target organ or blood vessel while said expandable member is positioned therein;

a control member operatively attachable at one end thereof to control expansion of said expandable member through said tubular member; and

a vessel plug operatively associated with said tubular member and said expandable member, said vessel plug dimensioned to close the puncture or incision, said expandable member, when in said expanded condition within said blood vessel or said target organ, preventing said vessel plug from extending into said vessel or said organ.

41. The apparatus of claim 40 wherein said vessel plug is a cylindrical rod constructed of a biodegradable material.

42. The apparatus of claim 40 further including an introducer having a lumen extending longitudinally therethrough, said introducer dimensioned to receive said catheter and said expandable member within said lumen.

43. A method for sealing or closing an incision or puncture in the body of the living patient wherein the incision or puncture extends into a blood vessel or organ of the patient, the method comprising:

inserting an elongated tubular member into the incision, said elongated tubular member having a distal end and a proximal end and having an expandable member disposed at said distal end, said expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

expanding said expandable member within said blood vessel or said target organ;

positioning a surface of said expandable member adjacent the incision or puncture in said blood vessel or said target organ;

inserting a vessel plug into said incision or puncture, said expandable member operating in said expanded condition to prevent said vessel plug from extending into said vessel or target organ of said patient;

positioning said expandable member in said relaxed condition; and

retracting said elongated tubular member and said expandable member from said incision or puncture while retaining said vessel plug within said incision or puncture.

44. The method of claim 43 wherein said inserting of an elongated tubular member into the incision is accomplished by inserting said tubular member through a sheath introducer extending from the skin of the patient and into said vessel or target organ.

45. The method of claim 43 wherein said inserting of said vessel plug includes providing said plug as a cylindrical member made of a biodegradable material;

and inserting said plug in said wound or incision to a location adjacent said expandable member adjacent the incision.