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

• US 5,275,616 A
• Filed: 12/18/1992
• Issued: 01/04/1994
• 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): Pellegrino, Stephen C.
• Assistant Examiner(s): Jackson, Gary
• Application Number:
  US07/993,328
• Time in Patent Office: 382 Days
• Field of Search: 606/213, 606/215, 606/230, 604/15, 604/285, 604/286, 604/287, 604/288, 604/57, 604/59, 604/68-70
• 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 through the lumen of a blood vessel and into a blood vessel of the patient, said closure device including a plug means comprising:

an elongate and generally cylindrical vessel plug having distal and proximal ends, and said vessel plug has a length sufficient to be received in the incision such that said distal end is positioned at a first predetermined position in the incision proximally of the lumen of the blood vessel of the patient, and said proximal end is positioned adjacent to the outer surface skin of the patient to obstruct the flow of blood from the blood vessel into the incision; and

wherein said distal end of said vessel plug is oriented at an angle of approximately 25 to 45 degrees with respect to the lengthwise dimension of said vessel plug.

2. The closure device of claim 1 wherein said vessel plug is constructed of a biodegradable material having a radiopaque material therein.

3. The closure device of claim 1 wherein said vessel plug is constructed of a biodegradable material having a clotting agent therein.

4. The closure device of claim 1 further including en elongate tubular member and said tubular member includes an open distal end and a proximal end wherein said proximal end includes a plunger member operatively associated therewith and said vessel plug is dimensioned to be expelled through said distal end of said tubular member into the incision.

5. A closure device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient through the lumen of a blood vessel and into a blood vessel of the patient, said closure device including a plug means comprising:

an elongate and generally cylindrical vessel plug having distal and proximal ends and said vessel plug has a length sufficient to be received in the incision such that said distal end is positioned at a first predetermined position in the incision proximally of the lumen of the blood vessel of the patient and said proximal end is positioned adjacent to the outer surface skin of the patient to obstruct the flow of blood from the blood vessel into the incision; and

further including a tubular member and wherein at least a portion of said tubular member is dimensioned to be received through the incision to identify the location of the blood vessel adjacent to the incision and an expulsion means is movable with respect to said tubular member to expel said vessel plug from said tubular member such that said distal end of said vessel plug is positioned in said first predetermined position in the incision proximally of the blood vessel of the patient.

6. An insertion assembly for 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 the blood vessel and into a blood vessel of the patient, said insertion assembly comprising in combination:

a vessel plug having distal and proximal ends and being formed of a material which is absorbable in the body of the patient, said vessel plug being dimensioned to be inserted into the incision of the patient such that sad distal end of said vessel plug is positioned along the outer surface of the blood vessel of the patient and said proximal end is positioned generally adjacent to the outer surface of the skin of the patient;

a removable insertion member having proximal and distal ends wherein said distal end is dimensioned to facilitate the identification of the location of the lumen of the blood vessel adjacent to the incision and assist in the placement of said distal end of said vessel plug along the outer surface of the blood vessel; and

wherein said vessel plug is an elongate and generally cylindrical member, and said distal end of said vessel plug is oriented at an angle of approximately 25 to 45 degrees with respect to the lengthwise dimension of said vessel plug.

7. The insertion assembly of claim 6 wherein said insertion member is an elongate member having sufficient length so that said proximal end of said insertion member extends proximally of the skin of the patient adjacent to the incision as said distal end of said insertion member contacts the inner lumen of the blood vessel.

8. The insertion assembly of claim 7 wherein said vessel plug is dimensioned to conform to the incision between the outer lumen of the blood vessel and the outer surface of the skin of the patient.

9. 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 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.

10. The method of claim 9 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.

11. The method of claim 9 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.

12. The method of claim 11 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.

13. The method of claim 9 further including the step of expanding location means on an insertion member to identify the location of the blood vessel adjacent to the incision.

14. The method of claim 9 further including the step of inflating a member on an insertion member to identify the location of the blood vessel adjacent to the incision.

15. The method of claim 9 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.

16. 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 or organ of the patient, the method comprising:

inserting a positioning means into the incision,

expanding a balloon member along the distal end portion of the positioning means;

inserting a means for sealing the incision into the incision such that the flow of blood through the incision is obstructed by the means for sealing; and

removing the positioning means from the incision.

17. The method of claim 16 wherein the positioning means is provided as an elongate member having a lumen extending between a proximal end portion thereof and the balloon member and the method includes the step of inflating the balloon member generally along the incision.

18. The method of claim 16 wherein said means for clotting is provided as a sponge-like member having a clotting agent therein.

19. 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 vessel plug which is constructed of a material that is absorbable within the body of a patient and which seals the incision from the flow of blood therethrough; and

an elongate positioning member having a passageway therein for the receipt of said vessel plug 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 placement of said vessel plug at a predetermined position in the incision proximally of the blood vessel.

20. The insertion assembly of claim 19 wherein said vessel plug is sized to be received in said positioning member prior to use and is expelled therefrom to said predetermined position in the incision by a plunger member which is operatively associated with said positioning member.