Vascular sealing device

• US 5,383,896 A
• Filed: 05/25/1993
• Issued: 01/24/1995
• Est. Priority Date: 05/25/1993
• Status: Expired due to Fees

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Gershony, Gary, Nowakowski, Karol W.
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US08/067,213
• Time in Patent Office: 609 Days
• Field of Search: 606/192, 606/194, 606/213, 606/215, 606/232, 604/49, 604/51-53, 604/96, 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 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 typically placed through a vascular 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 The balloon is inflated and withdrawn until it engages the inner surface of the blood vessel or body cavity. The sheath is withdrawn from within the blood vessel or other body cavity to the outside of the body. A fixation collar loaded onto the shaft of the device allows for securement in place, within the blood vessel or other body cavity.

Claims

1. A medical sealing apparatus for closing of an aperture in a patient body, 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 patient body aperture and having an inflation segment including an external orifice which is communicatively connected to said lumen, said conduit proximal end having a cylindrical configuration of a uniform outside diameter;

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

c. 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; and

d. a fixation member having a base portion for contact with the patient body and means to engage said conduit until the patient body aperture is closed.

2. The medical sealing device 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.

3. The medical sealing device of claim 2, wherein said conduit comprises hypotubing.

4. The medical sealing device 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.

5. 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.

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

7. The medical sealing device of claim 5, 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.

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

9. The medical sealing device 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.

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

11. The medical sealing device of claim 9, wherein said expandable member is a pneumatic member which is inflatable via a gas.

12. The medical sealing device of claim 1, 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.

13. The medical sealing device of claim 1, wherein said apparatus is useable with a hemostatic valve introducer to seal a percutaneous puncture in the vascular system of a patient body, said conduit distal end being insertable through said introducer and the percutaneous puncture, said expandable member being first uninflated, said expandable member then being inflated, said conduit being slightly retracted to abut said expandable member against the percutaneous puncture, said introducer being removed from the percutaneous puncture, and said means to apply a tensive force engaging said conduit until patient body aperture closure.

14. A medical sealing apparatus for closing a percutaneous puncture in a patient'"'"'s vascular system and for use with a hemostatic introducer, comprising:

a. a thin, elongated conduit having a predetermined outside diameter and 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, said inflation segment coaxially extending from conduit distal end, said conduit proximal end having cylindrical outside configuration of the same diameter as that of said conduit;

b. a hollow, inflatable member sealingly disposed at said conduit distal end inflation segment, said member being inflatable to a predetermined diameter, said member having 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 said member having a rounded configuration in an inflated state;

c. a seal adhereingly disposed within said conduit central lumen along a predetermined segment at said proximal end thereof, said seal consisting of a continuous, homogeneous packing of elastomeric material, said seal permitting sealing ingress and egress of a syringe to inject or evacuate a fluid into or from said conduit lumen for inflation and deflation of said inflatable member; and

d. a fixation member for securement of said conduit in a fixed position on the patient body exterior, said fixation member having a base portion for contact with the patient body and means to engage said conduit.

15. A method for closing a percutaneous puncture in a patient'"'"'s vascular system and which is insertable and removable through a standard, hemostatic sheath, 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, said conduit proximal end having a cylindrical outside configuration of a uniform diameter;

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

iii. 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; and

iv. a securement member for fixing the position of the conduit on the patient body exterior, said securement member having a base portion for contact with the patient body and means to engage said conduit;

b. inserting said apparatus through the sheath and into the percutaneous puncture;

c. inflating said inflatable member by inserting a syringe through said elastomeric seal and injecting fluid into said central lumen;

d. positioning said inflatable member into contact with the patient'"'"'s vasculature;

e. withdrawing the sheath longitudinally over said conduit; and

f. securing said conduit in a fixed position at the patient body exterior via said fixation member.

16. A medical sealing apparatus for closing of an aperture in a patient body, 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 patient body aperture and having an inflation segment including an external orifice which is communicatively connected to said lumen, said conduit proximal end having a cylindrical configuration of a uniform outside diameter;

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

c. 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; and

d. means to apply a longitudinally oriented tension force on the exterior of a patient body, with respect to said conduit central axis, to said expandable member when in an inserted, inflated state, whereby said expandable member is held in a stable position internal to the patient body aperture until the patient body aperture is closed.