Vascular sealing apparatus and method

• US 5,626,601 A
• Filed: 10/27/1995
• Issued: 05/06/1997
• Est. Priority Date: 10/27/1995
• Status: Expired due to Fees

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Gary Gershony
• Inventors: Gershony, Gary, Horzewski, Michael J., Kasprzyk, Daniel J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/549,332
• Time in Patent Office: 557 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/198, 606/213, 623/1, 623/12, 604/96, 604/101
• US Class Current: 606/194
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

A vascular sealing device for effecting closure of a puncture or other opening in a blood vessel, or other body cavity, which has been entered through percutaneous techniques. The device is useable with a standard percutaneous vascular introducer. The vascular sealing device generally comprises a body or shaft, an adapter disposed at a proximal end of the shaft, and a balloon portion disposed generally at a distal end of the shaft. A core wire is connected to the distal end and extends, internally, through a lumen of the device for deflation of the balloon. A procoagulant is introduced through the introducer, or alternatively through an additional lumen and associated apertures, and to the puncture sealed by the inflated balloon. Subsequently, the balloon is deflated and the device is removed from the sealing puncture, with or without the aid of a reaccess sheath.

Claims

1. A medical sealing apparatus for use in closing an opening in a blood vessel, comprising:

(a) a body structure having a proximal and a distal end, said body structure timber having an elongated tubular shaft with proximal and distal ends, an adapter connected to said proximal end of said shaft, and a central lumen extending axially through said shaft and said adapter;

(b) an inflatable member disposed adjacent said distal end of said shaft and communicatively connected to said lumen, said inflatable member having an inflated diameter and a deflated diameter which is less than that of said inflated diameter;

(c) means to introduce a procoagulant to the blood vessel opening at a point proximally located with respect to said inflatable member; and

(d) means, connected to said body structure, to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation.

2. The medical sealing apparatus of claim 1, wherein said means to introduce a procoagulant is an introducer having an axial lumen opening to a distal insertion end adapted for location in the blood vessel opening, a fluid injection port being communicatively connected to said introducer lumen, said body structure shaft being extended through said introducer lumen so that said inflatable member is disposed outwardly beyond said introducer distal insertion end, procoagulant being introduced to said introducer lumen via said fluid injection port and distributed out said distal insertion end.

3. The medical sealing device of claim 1, wherein said means to introduce a procoagulant comprises a procoagulant introduction lumen disposed within said body structure, a procoagulant ingress port disposed on an exterior surface of said body structure and being communicatively connected to said introduction lumen, and at least one procoagulant egress aperture disposed at a predetermined location on said body structure and being communicatively connected to said introduction lumen.

4. The medical sealing device of claim 3, wherein said procoagulant introduction lumen extends axially through said body structure shaft and adapter, wherein said procoagulant ingress port is disposed on said adapter, and wherein said at least one procoagulant egress aperture is disposed on said shaft at a predetermined location relative to said inflatable member.

5. The medical sealing device of claim 1, wherein said means to longitudinally compress and stretch comprises an elongated wire member connected to said body structure shaft distal end and extending proximally through said central lumen and out a proximal aperture in said body structure adapter, said means to longitudinally compress and stretch further comprising means, disposed at said adapter proximal aperture, to lock said wire in a predetermined position.

6. The medical sealing device of claim 5, wherein said means to lock said wire comprises an O-Ring disposed at a predetermined position in said body structure adapter and annularly about said central lumen, and a compressive cap adjustably longitudinally compressing said O-Ring and urging said O-Ring into lateral frictional engagement with said wire in said central lumen.

7. The medical sealing device of claim 1, further comprising a sheath slidably disposed over said body structure shaft, said sheath having a proximal end, a distal end, and a predetermined length whereby said inflatable member extends beyond said distal end of said sheath, said sheath further having an inside dimension which is slightly greater than an outside dimension of said shaft.

8. The medical sealing device of claim 1, further comprising a radiopaque marker band disposed at a predetermined position on said body structure.

9. The medical sealing device of claim 1, further comprising a flexible tip structure connected to said distal end of said body structure shaft, distally with respect to said inflatable member.

10. The medical sealing device of claim 1, wherein said body structure adapter has an inflation port communicatively connected to said central lumen and wherein said central lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said central lumen to inflate said inflation member.

11. The medical sealing device of claim 1, wherein said body structure adapter has an inflation port and a communicatively connected longitudinal inflation lumen, and wherein said inflation lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said inflation lumen to inflate said inflation member.

12. The medical sealing device of claim 1, wherein said body structure adapter has an inflation port communicatively connected to said central lumen and wherein said central lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said central lumen to inflate said inflation member, and wherein said means to introduce a procoagulant is an introducer having an axial lumen opening to a distal insertion end adapted for location in the blood vessel opening, a fluid injection port being communicatively connected to said introducer lumen, said body structure shaft being extended through said introducer lumen so that said inflatable member is disposed outwardly beyond said introducer distal insertion end, procoagulant being introduced to said introducer lumen via said fluid injection port and distributed out said distal insertion end, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation, and wherein said device further comprises a sheath slidably disposed over said body structure shaft, said sheath having a proximal end, a distal end, and a predetermined length whereby said inflatable member extends beyond said distal end of said sheath, said sheath further having an inside dimension which is slightly greater than an outside dimension of said shaft.

13. The medical sealing device of claim 1, wherein said body structure adapter has an inflation port and a communicatively connected longitudinal inflation lumen, and wherein said inflation lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said inflation lumen to inflate said inflation member, and wherein said means to introduce a procoagulant comprises a procoagulant introduction lumen disposed within said body structure, a procoagulant ingress port disposed on an exterior surface of said body structure and being communicatively connected to said introduction lumen, and at least one procoagulant egress aperture disposed at a predetermined location on said body structure and being communicatively connected to said introduction lumen, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation.

14. The medical sealing device of claim 1, wherein said body structure adapter has an inflation port communicatively connected to said central lumen and wherein said central lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said central lumen to inflate said inflation member, and wherein said means to introduce a procoagulant comprises a procoagulant introduction lumen disposed within said body structure, a procoagulant ingress port disposed on an exterior surface of said body structure and being communicatively connected to said introduction lumen, and at least one procoagulant egress aperture disposed at a predetermined location on said body structure and being communicatively connected to said introduction lumen, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation.

15. A method for closing a puncture or other opening in a blood vessel, comprising the steps of:

(a) inserting a balloon apparatus through an introducer which is disposed in the blood vessel opening;

(b) inflating said balloon apparatus;

(c) moving said balloon apparatus into contact with the opening;

(d) introducing a procoagulant to the opening;

(e) deflating said balloon apparatus; and

(f) removing said balloon apparatus through the opening.

16. The method of claim 15, wherein said procoagulant is injected through the introducer.

17. The method of claim 15, wherein said procoagulant is injected through the balloon apparatus.

18. The method of claim 15, further comprising the steps of configuring said balloon apparatus by compressing said balloon apparatus subsequent to inflating said balloon apparatus, and of configuring said balloon apparatus by stretching said balloon apparatus prior to removing said balloon apparatus.

19. A medical sealing apparatus for use in closing an opening in a blood vessel, comprising:

(a) a body structure having a proximal and a distal end, said body structure further having an elongated tubular shaft with proximal and distal ends, an adapter connected to said proximal end of said shaft, and a central lumen extending axially through said shaft and said adapter;

(b) an inflatable member disposed adjacent said distal end of said shaft and communicatively connected to at least one said lumen; and

(c) means to introduce a procoagulant to the blood vessel opening at a point proximally located with respect to said inflatable member, and wherein said body structure adapter has an inflation port communicatively connected to said central lumen and wherein said central lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said central lumen to inflate said inflation member, and wherein said means to introduce a procoagulant is an introducer having an axial lumen opening to a distal insertion end adapted for location in the blood vessel opening, a fluid injection port being communicatively connected to said introducer lumen, said body structure shaft being extended through said introducer lumen so that said inflatable member is disposed outwardly beyond said introducer distal insertion end, procoagulant being introduced to said introducer lumen via said fluid injection port and distributed out said distal insertion end, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means, connected to said body structure, to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation, and wherein said device further comprises a sheath slidably disposed over said body structure shaft, said sheath having a proximal end, a distal end, and a predetermined length whereby said inflatable member extends beyond said distal end of said sheath, said sheath further having an inside dimension which is slightly greater than an outside dimension of said shaft.

20. A medical sealing apparatus for use in closing an opening in a blood vessel, comprising:

(a) a body structure having a proximal and a distal end, said body structure further having an elongated tubular shaft with proximal and distal ends, an adapter connected to said proximal end of said shaft, and a central lumen extending axially through said shaft and said adapter;

(b) an inflatable member disposed adjacent said distal end of said shaft and communicatively connected to at least one said lumen; and

(c) means to introduce a procoagulant to the blood vessel opening at a point proximally located with respect to said inflatable member, and wherein said body structure adapter has an inflation port and a communicatively connected longitudinal inflation lumen, and wherein said inflation lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said inflation lumen to inflate said inflation member, and wherein said means to introduce a procoagulant comprises a procoagulant introduction lumen disposed within said body structure, a procoagulant ingress port disposed on an exterior surface of said body structure and being communicatively connected to said introduction lumen, and at least one procoagulant egress aperture disposed at a predetermined location on said body structure and being communicatively connected to said introduction lumen, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means, connected to said body structure, to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation.

21. A medical sealing apparatus for use in closing an opening in a blood vessel, comprising:

(a) a body structure having a proximal and a distal end, said body structure further having an elongated tubular shaft with proximal and distal ends, an adapter connected to said proximal end of said shaft, and a central lumen extending axially through said shaft and said adapter;

(b) an inflatable member disposed adjacent said distal end of said shaft and communicatively connected to at least one said lumen; and

(c) means to introduce a procoagulant to the blood vessel opening at a point proximally located with respect to said inflatable member, and wherein said body structure adapter has an inflation port communicatively connected to said central lumen and wherein said central lumen is communicatively connected to said inflation member, whereby fluid is introduced in said inflation port and through said central lumen to inflate said inflation member, and wherein said means to introduce a procoagulant comprises a procoagulant introduction lumen disposed within said body structure, a procoagulant ingress port disposed on an exterior surface of said body structure and being communicatively connected to said introduction lumen, and at least one procoagulant egress aperture disposed at a predetermined location on said body structure and being communicatively connected to said introduction lumen, and wherein said inflatable member has an inflated diameter and a deflated diameter which is less than that of said inflated diameter, and wherein said device further comprises means, connected to said body structure, to longitudinally compress said inflatable member so that it assumes a predetermined configuration during an inflation and to longitudinally stretch said inflatable member so that it returns to said deflated diameter subsequent to an inflation.