Vascular sealing apparatus

• US 6,296,658 B1
• Filed: 01/25/2000
• Issued: 10/02/2001
• Est. Priority Date: 05/25/1993
• Status: Expired due to Fees

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Kasprzyk, Daniel J., Gershony, Gary, Horzewski, Michael J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/491,108
• Time in Patent Office: 616 Days
• Field of Search: 606/159, 606/213, 606/169, 606/139, 606/140, 606/141-145, 606/192, 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 The balloon is inflated and withdrawn until it engages the inner surface of the blood vessel.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 After a predetermined time period, the balloon is deflated and the device is withdrawn.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 medical sealing apparatus for sealing a blood vessel aperture in a patient, comprising:

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

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

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

d. means to introduce a procoagulant to the blood vessel opening; and

e. a seal consisting of an elastomeric material continuously and adhereingly disposed in said conduit central lumen along a predetermined segment at said proximal end thereof, said seal permitting ingress and egress of fluid to and from said conduit lumen via a syringe.

3. The medical sealing device of claim 1, wherein said conduit comprises hypotubing.

4. The medical sealing device 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.

5. The medical sealing device of claim 4, wherein said conduit and said inflation segment comprise a unitary structure constructed of a homogeneous substance.

6. The medical sealing device of claim 4, further comprising an atraumatic extension disposed at an outward end of said inflation segment opposite its point of connection with said conduit, said atraumatic extension being constructed of a flexible material.

7. The medical sealing device of claim 6, wherein said conduit, said inflation segment, and said atraumatic extension comprise a unitary structure constructed of a homogeneous substance.

2. A medical sealing apparatus for sealing a blood vessel aperture in a patient, comprising:

(a) a vascular introducer member comprising;

(i) a thin, substantially straight body,

(ii) a central lumen of a predetermined inside diameter in said body, and

(iii) a side port communicatively connected to said central lumen, said side port being for introduction of a procoagulant to said central lumen and to the blood vessel aperture; and

(b) a vascular sealing member adapted for insertion into and retraction from said central lumen of said vascular introducer member, said vascular sealing member comprising;

(i) a thin, straight, elongated conduit having an outside diameter slightly less than said vascular introducer member central lumen inside diameter, and a central lumen, said conduit having proximal and distal ends, said outside diameter being substantially uniform from said proximal end to said distal end, said conduit end being insertable into the blood vessel 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;

(iii) a seal consisting of an elastomeric material disposed in said conduit central lumen at said proximal end thereof, said seal permitting ingress and egress of fluid to and from said conduit lumen via a syringe.

8. The medical sealing device of claim 2, 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.

9. The medical sealing device of claim 8, wherein said expandable member has a rounded configuration in an inflated state.

10. The medical sealing device of claim 8, wherein said expandable is a pneumatic member which is inflatable via a gas.

11. The medical sealing device of claim 8, wherein said expandable member is a hydraulic member which is inflatable via a liquid.

12. The medical sealing device of claim 8, wherein said expandable member has a diameter greater than the size of the patient body aperture which is being sealed.

13. The medical sealing device of claim 2, wherein:

(i) said inflation segment is coaxially disposed from 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.

14. The medical sealing device of claim 2, wherein said means to introduce a procoagulant releases procoagulant at said blood vessel aperture at a point proximally located with respect to said expandable member.

15. A medical, vascular sealing apparatus for closing an aperture in a patient blood vessel, consisting essentially of:

(a) a sealing member, consisting essentially of;

(i) a thin, straight, cylindrical elongated conduit having a predetermined outside diameter, and a central lumen, said conduit having proximal and distal ends, said outside diameter being uniform throughout its entire length from said proximal to said distal end, 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, said inflation segment coaxially extending from conduit distal end;

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

(iii) an elastomeric sealing member for connection of said conduit lumen to an external inflation syringe, said sealing member being sealingly and adhereingly disposed in said conduit lumen at said proximal end thereof; and

(b) a hemostasis valve-type introducer member having a body of a predetermined outside diameter and including a proximal hemostasis valve, a single longitudinal lumen in said body extending from and through said hemostasis valve and opening to an open distal insertion end, said lumen having a predetermined diameter which is slightly greater than said conduit outside diameter, said insertion end being adapted for location in the blood vessel aperture, a single, proximal, lateral fluid injection port communicatively connected to said introducer lumen, whereby said conduit is extended through said introducer lumen so that said expandable member is disposed outwardly beyond said introducer distal insertion end, said fluid injection port being adapted to receive procoagulant and distribute said procoagulant out said distal insertion end, and whereby said sealing member is slideable in said introducer member lumen throughout its entire length, including through said hemostasis valve, for proximal withdrawal of said introducer member over said sealing member without splitting said introducer member, so that the sealing member may remain at the vessel aperture.

16. A method for closing an aperture in a patient'"'"'s blood vessel;

comprising the steps of;

a. positioning a vascular introducer member in the patient'"'"'s blood vessel aperture, said introducer member comprising;

(i) a thin, substantially straight body with an open proximal end and an open distal end,

(ii) a central lumen of a predetermined inside diameter, disposed in said body, and

(iii) a side port communicatively connected to said central lumen;

said body distal end being disposed in the patient'"'"'s blood vessel;

b. engaging a medical, vascular sealing member with said introducer member, said sealing member comprising;

(i) a thin, elongated conduit having an outside diameter slightly less than said introducer member central lumen inside diameter, and a central lumen, said conduit having proximal and distal ends, said outside diameter being uniform from said proximal end to said distal end, 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) a seal consisting of an elastomeric material disposed in said conduit central lumen at said proximal end;

said sealing member being inserted into said introducer member proximal end through said introducer member lumen and into the blood vessel aperture extending said conduit through said introducer lumen so that said expandable member is disposed outwardly beyond said introducer distal end;

c. inflating said expandable member by piercing said elastomeric seal with a syringe and injecting fluid therefrom;

d. moving said sealing member conduit through said introducer member lumen to bring said expandable member into contact with the blood vessel aperture;

e. depositing procoagulant at said patient blood vessel aperture for rapid closure by introducing procoagulant into said introducer member lumen though said introducer member side port and distributing said procoagulant out said distal end thereof while said sealing member expandable member is still inflated;

f. disengaging said sealing member from said introducer member by proximally sliding said introducer member over the entire length of said sealing member, including said proximal end thereof, so that the sealing member remains alone in the vessel aperture until the aperture is closed; and

g. removing said sealing member.