Vascular sealing apparatus

• US 6,017,359 A
• Filed: 06/17/1997
• Issued: 01/25/2000
• Est. Priority Date: 05/25/1993
• Status: Expired due to Fees

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Horzewski, Michael J., Kasprzyk, Daniel J., Gershony, Gary
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/877,255
• Time in Patent Office: 952 Days
• Field of Search: 606/193, 606/213, 606/194, 604/178, 604/256
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 2202/0425 Thrombin

Abstract

A device for sealing an opening or puncture in the wall of a blood vessel or other percutaneous openings. The device includes a shaft section member of a small diameter, with an expandable balloon and atraumatic tip at its distal end. The proximal end of the device has an inflation/deflation port which is utilized to inflate the balloon once it is in place within the blood vessel or other body cavity. The entire device is placed through a hemostasis vascular introducer or sheath, which is used during invasive percutaneous vascular procedures. The balloon is inflated and withdrawn until it engages the inner surface of the blood vessel. A procoagulant is injected via the introducer to the puncture. After a predetermined time period, the balloon is deflated and the device is withdrawn.

Claims

1. A method for closing of an aperture in a patient'"'"'s blood vessel through an introducer predisposed in the blood vessel aperture, the introducer being of a type having an axial lumen opening to a distal insertion end adapted for location in the blood vessel aperture, and a fluid injection port being communicatively connected to the introducer lumen;

comprising the steps of;

a. providing a medical sealing apparatus, comprising;

i. a thin, elongated conduit having a central lumen, said conduit having proximal and distal ends, said conduit distal end being insertable into the patient body aperture and having an inflation segment including an external orifice which is communicatively connected to said lumen;

ii. an expandable member sealingly disposed at said conduit distal end inflation segment, said expandable member being inflatable to a predetermined diameter; and

iii. means to connect said conduit lumen to an external inflation source, said means to connect being disposed at said proximal end of said conduit;

b. inserting said apparatus through the introducer lumen and into the blood vessel aperture, said apparatus conduit being extended through said introducer lumen so that said apparatus expandable member is disposed outwardly beyond said introducer distal insertion end;

c. inflating said expandable member;

d. moving said expandable member into contact with the blood vessel aperture; and

e. introducing procoagulant into said introducer lumen via said fluid injection port and distributing said procoagulant out said distal insertion end.

2. The method of claim 1, comprising the further step of deflating said expandable member.

3. The method of claim 2, wherein said deflation is effected within about 1 minute after moving said expandable member into contact with the blood vessel aperture.

4. The method of claim 2, wherein said deflation is effected within a time period of between about one and three minutes.

5. The method of claim 1, wherein said conduit has a predetermined outside diameter and length, and is constructed of a metallic material having a predetermined degree of rigidity.

6. The method of claim 5, wherein said conduit comprises hypotubing.

7. The method of claim 1, wherein said conduit has a predetermined outside diameter and length, and is constructed of a polymeric material having a predetermined degree of rigidity.

8. The method of claim 1, wherein said inflation segment is a hollow tubular structure extending coaxially from said conduit distal end and having a predetermined outside diameter which is not greater than the diameter of said conduit at said distal end thereof, and a predetermined length, and wherein said central lumen is coextensive with said inflation segment.

9. The method of claim 8, wherein said conduit and said inflation segment comprise a unitary structure constructed of a homogeneous substance.

10. The method of claim 8 wherein said inflation segment comprises an atraumatic extension disposed at an outward end of said segment, opposite its point of connection with said conduit, said atraumatic extension being constructed of a flexible material.

11. The method of claim 10, wherein said conduit, said inflation segment, and said atraumatic extension comprise a unitary structure constructed of a homogeneous substance.

12. The method of claim 1, wherein said expandable member has a tubular configuration in an uninflated state with a tube wall and opposing tube ends, said tube ends being sealingly secured to said inflation segment.

13. The method of claim 12, wherein said expandable member has a rounded configuration in an inflated state.

14. The method of claim 12, wherein said expandable member is a pneumatic member which is inflatable via a gas.

15. The method of claim 12, wherein said expandable member is a hydraulic member which is inflatable via a liquid.

16. The method of claim 12, wherein said expandable member has a diameter greater than the size of the patient body aperture which is being sealed.

17. The method of claim 1, wherein:

i) said inflation segment is coaxially disposed from said conduit distal end, and wherein said central lumen is coextensive with said extension member;

ii) said expandable member has a tubular configuration in an uninflated state with a tube wall and opposing tube ends, said tube ends being sealingly secured to said inflation segment; and

iii) said expandable member has a rounded configuration in an inflated state.

18. The method of claim 1, wherein said connection means comprises an elastomeric sealing member.

19. The method of claim 18, wherein said elastomeric sealing member comprises an elastomeric packing disposed in said conduit central lumen at said proximal end thereof.

20. The method of claim 1, wherein said procoagulant is released at said blood vessel aperture at a point proximally located with respect to said expandable member.