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

• US 5,716,375 A
• Filed: 02/21/1996
• Issued: 02/10/1998
• 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): Buiz, Michael
• Assistant Examiner(s): SHAI, DAPHNA
• Application Number:
  US08/604,203
• Time in Patent Office: 720 Days
• Field of Search: 606/220, 606/232, 606/139, 604/15, 604/60, 604/265, 604/93, 604/96, 604/181
• 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 method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient into a blood vessel of the patient, the method comprising:

inserting a relatively small diameter balloon catheter through the previously formed incision in the patient;

inflating a balloon on the distal end of the balloon catheter;

withdrawing the balloon catheter from the incision until the balloon contacts a predetermined portion of the inner lumen of the blood vessel; and

deflating the balloon on the balloon catheter and removing the balloon catheter from the incision.

2. 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 wall of a blood vessel and into a blood vessel of the patient, the method comprising:

inserting an elongate member having distal and proximal end portions and an actuatable member thereon into the incision in the patient;

actuating the actuatable member on the elongate member to cause the movement of the actuatable member from a first position with respect to the elongate member to a second position wherein the actuatable member extends laterally of the distal end portion of the elongate member when the actuatable member is in the second position;

moving the elongate member to a position in the blood vessel in the patient until the actuatable member contacts a predetermined portion of the blood vessel in the patient to enable the user to determine the location of the blood vessel; and

removing the elongate member from the incision and blood vessel.

3. The method according to claim 2, further including the step of actuating the movement of the actuatable member from the second position to the first position prior to removing the elongate member from the incision.

4. The method according to claim 3, further including the step of causing the radial expansion of the actuatable member as the actuatable member is moved from the first to the second position.

5. The method according to claim 3, further including the step of causing the lateral extension of one or more members of the actuatable member as the actuatable member is moved from the first to the second position.

6. The method according to claim 2, further including actuating a member associated with the proximal end portion of the elongate member to cause the movement of the actuatable member from the first position to the second position to position the elongate member in the incision and blood vessel determined by the contact between the elongate member and the blood vessel.

7. The method according to claim 2, further including the step of withdrawing the elongate member in the incision until the actuatable member contacts at least a portion of the wall of the blood vessel of the patient.

8. The method according to claim 2, further including the step of withdrawing the elongate member in the incision until the actuatable member contacts at least a portion of the wall of the blood vessel of the patient which is adjacent to the incision.

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 into a blood vessel of the patient, the method comprising the steps of:

inserting an elongate member having distal and proximal ends with at least one laterally extendable member along the distal end portion thereof and a movement causing member associated with the proximal end portion thereof into the incision in the patient;

causing the movement of the extendable member laterally along the distal end portion of the elongate member to increase the radius of the distal end portion of the elongate member; and

withdrawing the elongate member from the incision until the extendable member contacts the inner lumen of the blood vessel.

10. The method of claim 9, further including the step of returning the locating member to a reduced radius and withdrawing the elongate member from the incision.

11. The method of claim 9, further including the step of actuating the movement causing member on the proximal end portion of the elongate member to return the locating member to a reduced radius to enable the elongate member to be withdrawn from the incision and past the wall of the blood vessel.

12. 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 wall of a blood vessel and into a blood vessel of the patient, the method comprising:

inserting an elongate member having distal and proximal end portions into the incision and blood vessel of the patient and moving the elongate member to a position in the incision and blood vessel in the patient to enable the user to determine the location of the blood vessel; and

sealing the incision in accordance with the location determined by the elongate member to create a seal in the incision without extending th seal into the blood vessel such that the flow of blood through the blood vessel is unobstructed and the flow of blood through the incision is prevented.

13. The method according to claim 12, further including the step of actuating the movement of an actuatable member which is operatively interconnected with the elongate member from a first position to a second laterally extended position with respect to the elongate member to locate the blood vessel of the patient.

14. The method according to claim 13, further including the step of causing the lateral extension of the actuatable member as the actuatable member is moved from the first to the second position to contact the wall of the blood vessel of the patient.

15. The method according to claim 12, further including the step of causing the lateral extension of one or more members of an actuatable member which is operatively interconnected with the elongate member as the actuatable member is moved from a first to a second position with respect to the elongate member.

16. The method according to claim 12, further including actuating a member which is operatively interconnected with the proximal end portion of the elongate member to cause a bioabsorbable material to be located at a desired location in the incision to obstruct the flow of blood through the incision.

17. The method according to claim 16, further including the step of withdrawing the elongate member from the incision after the bioabsorbable material is positioned in the incision.

18. The method according to claim 12, further including the step of withdrawing the elongate member in the incision until an actuatable member associated with the elongate member contacts at least a portion of the wall of the blood vessel of the patient which is adjacent to the incision.

19. The method according to claim 12, further including the step of inserting a bioabsorbable material into the incision in accordance with the location of the blood vessel determined by the contact between the actuatable member and the wall of the blood vessel.

20. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient, past the wall of the blood vessel and into a blood vessel of the patient, the method comprising the steps of:

inserting an elongate member having distal and proximal ends into the incision and blood vessel of the patient;

withdrawing the elongate member in the incision and blood vessel to identify the location of the wall of the blood vessel;

sealing the incision in accordance with the location of the wall of the blood vessel determined by the elongate member to create a seal in the incision without extending the seal into the blood vessel and so that the flow of blood through the blood vessel is unobstructed; and

withdrawing the elongate member from the incision and the blood vessel.

21. 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 passage way therein for the receipt of said vessel plug therein, and at least a portion of said positioning member is expandable so that it has an outer diameter in use which is greater than the diameter of the incision to position said vessel plug in the incision proximally of the blood vessel such that said vessel plug obstructs the flow of blood through the incision without extending into the blood vessel.

22. The insertion assembly of claim 21, wherein said vessel plug is expelled from said elongate member to said predetermined position in the incision by a plunger member which is operatively associated with said positioning member.

23. An insertion assembly for sealing an incision formed 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:

an elongate member having a length sufficient to extend from the skin of the patient through the incision and into the blood vessel of the patient to identify the location of the blood vessel through the incision; and

a vessel plug formed of a hemostasis promoting material and having distal and proximal portions and said vessel plug sized to be received in the incision such that said distal portion is located at a first predetermined position in the incision proximally of the outer surface of the blood vessel of the patient as identified by said elongate member and said proximal portion is located at a second predetermined position proximally of said first predetermined position in the incision and proximally of the blood vessel of the patient.

24. The insertion assembly of claim 23, wherein said vessel plug is formed of said hemostasis promoting material and is absorbable within the body of the patient and is sized to extend in the incision between the outer skin surface of the patient and the proximal outer surface of the blood vessel.

25. The insertion assembly of claim 24, wherein said elongate member is a cylindrical member.

26. The insertion assembly of claim 25, wherein said elongate member includes a passageway extending therethrough.

27. The insertion assembly of claim 26, wherein said elongate member includes distal and proximal end portions and said proximal end portion thereof includes a plunger member operatively associated therewith.

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 positioning member into the incision and blood vessel to determine the location of the blood vessel through the incision; and

inserting a bioabsorbable vessel plug into the incision such that the vessel plug is positioned in the incision in accordance with the location determined by the positioning member to seal the incision from the flow of blood passing through the blood vessel without extending into the blood vessel.

29. The method of claim 28, further including the step of causing the positioning member to contact the wall of the blood vessel as the positioning member is moved in the incision and blood vessel.

30. The method of claim 28, further including the step of withdrawing the positioning member from the incision.

31. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient into a blood vessel of the patient, the method comprising the steps of:

inserting an assembly having a cylindrical member with distal and proximal ends and a vessel plug therein having distal and proximal ends and a plunger member associated with the proximal end of the vessel plug into the incision and blood vessel to a predetermined position in the incision wherein the distal end of the vessel plug is located proximally of the blood vessel; and

withdrawing the cylindrical member of the assembly from the incision and blood vessel while retaining the plunger member in a fixed position relative to the incision to maintain the vessel plug in the predetermined position in the incision.

32. The method of claim 31 further including the step of completely withdrawing the cylindrical member and the plunger member from the incision as the distal end of the vessel plug is retained in the incision.