Self-sealing vascular access device

• US 5,728,132 A
• Filed: 04/08/1996
• Issued: 03/17/1998
• Est. Priority Date: 04/08/1996
• Status: Expired due to Fees

• Current Assignee: Tricardia Ventures LLC
• Original Assignee: Tricardia Ventures LLC
• Inventors: Schwartz, Robert S., Van Tassel, Robert A., Holmes, David R.
• Primary Examiner(s): Tucker, Guy V.
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/629,022
• Time in Patent Office: 708 Days
• Field of Search: 604/65-67, 604/38, 604/41, 604/51, 604/53, 604/96, 606/213, 606/1, 606/108, 606/192, 606/185, 606/190, 128/748, 128/691
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24

Abstract

An instrument for achieving rapid hemostasis at the conclusion of a catheterization procedure comprises a device for injecting a fluid hemostatic agent into a puncture wound that is operatively associated with a conventional introducer sheath component of the introducer used to gain access to a blood vessel using the Seldinger technique. The hemostatic agent injection device includes a tubular member that can be concentrically disposed with a tubular introducer sheath so as to be slidable therealong and where the injection device includes a hemostatic agent inlet port at a proximal end thereof and an ejection port at a distal end, the two ports being interconnected by a lumen. In a first embodiment, the hemostatic agent injection device is adapted to coaxially surround the introducer sheath and in an alternate embodiment, the injection device is coaxially disposed within the lumen of the introducer sheath.

Claims

1. A device for sealing percutaneous punctures in a blood vessel, comprising:

(a) an elongated tubular member having a proximal end, an outwardly flared distal end portion and a working lumen extending therebetween, the elongated tubular member further including an injection lumen leading to at least one injection outlet port in the flared distal end portion; and

(b) a hub affixed to the proximal end of the elongated tubular member, the hub having an injection inlet port in fluid communication with the injection lumen adapted to transport a fluid hemostatic agent to said at least one injection outlet port and a bore aligned with the working lumen, with the bore and the working lumen dimensioned to receive a tubular vascular introducer sheath therethrough with the tubular introducer sheath being slidable relative to the elongated tubular member.

2. The device as in claim 1 wherein the flared distal end portion of the tubular member is shaped to facilitate entrance into dermal tissue when made to slide distally with respect to the tubular introducer.

3. The device as in any one of claims 1 and 2 and further including means for injecting a hemostatic agent into the injection lumen such that the hemostatic agent exits the injection outlet port.

4. The device as in claim 3 wherein the hemostatic agent is selected from the class consisting of thrombin, fibrin, fibrin glue, methacrylates, cyanoacrylates, collagen, platelet agonists, and vasoconstrictor drugs.

5. The device as in claim 4 wherein the vasoconstrictor drugs are selected from the group consisting of phenylephrine, norepinephrine, epinephrine, prostaglandin F2 alpha, endothelin, methergine, oxytocin and isoprel.

6. An apparatus for sealing percutaneous punctures in a blood vessel following a catheterization procedure, comprising in combination:

(a) a tubular introducer sheath having a distal end insertable into a wound resulting from percutaneous puncture of a blood vessel wall;

(b) a hemostatic agent injection device including a tubular member concentrically surrounding the tubular introducer sheath and slidable therealong, the injection device having a proximal hemostatic agent inlet port and a distal hemostatic agent ejection port and a lumen extending between the inlet port and the outlet port; and

(c) means for injecting the hemostatic agent, under pressure, into the inlet port following placement of the ejection port within the dermal layer surrounding the tubular introducer sheath.

7. The apparatus as in claim 6 wherein the hemostatic agent is selected from the class consisting thrombin, fibrin, fibrin glue, methacrylates, cyanoacrylates, collagen, platelet agonists, and vasoconstrictor drugs.

8. The apparatus as in claim 7 wherein the vasoconstrictor drugs are selected from the group consisting of phenylephrine, norepinephrine, epinephrine, prostaglandin F2 alpha, endothelin, methergine, oxytocin and isoprel.

9. An apparatus for sealing percutaneous punctures in a blood vessel following a catheterization procedure comprising, in combination:

(a) a tubular introducer sheath having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the distal end of the introducer sheath being insertable into a wound resulting from percutaneous puncture of a blood vessel wall and adapted to facilitate insertion of a working catheter into the blood vessel;

(b) a hemostatic agent injection device including a generally rigid tubular member concentrically located relative to the tubular introducer sheath, the device having an open proximal end and a lumen leading to a closed, tapered, distal end, with a side port leading to the lumen a predetermined distance proximal of the closed, tapered distal end;

(c) means on the injection device for sensing whether the side port is disposed within or outside of the blood vessel; and

(d) means for injecting a hemostatic agent through the lumen of the injection device after removal of the tubular introducer.

10. The apparatus of claim 9 and further including a plurality of additional side ports in the injection device leading to the lumen thereof.

11. The apparatus as in claim 9 wherein the means for sensing comprises an arterial blood pressure sensing means.

12. The apparatus as in claim 9 and further including a second lumen leading to an inflation port in a side wall of the injection device located distal to said side port and an inflatable balloon member affixed to the injection device and spanning the inflation port;

and means for introducing and extracting an inflation fluid into and from the second lumen.

18. The apparatus as any of claims 9-15 and 17 wherein the hemostatic agent is a member of the class consisting of thrombin, fibrin, fibrin glue, methacrylates, cyanoacrylates, collagen, platelet agonists, and vasoconstrictor drugs.

19. The apparatus as in claim 18 wherein the vasoconstrictor drugs are selected from the group consisting of phenylephrine, norepinephrine, epinephrine, prostaglandin F2 alpha, endothelin, methergine, oxytocin and isoprel.

13. An apparatus for sealing percutaneous puncture wounds in a blood vessel, comprising, in combination:

(a) a tubular introducer sheath having a proximal end, a distal end and a lumen extending therebetween, a distal end portion of the tubular introducer sheath adapted for placement through a patient'"'"'s dermal layer and through the puncture wound in the blood vessel to facilitate placement of instruments within the patient'"'"'s vascular system;

(b) a tubular hemostatic agent injection means having an inlet port and an outlet port with a lumen extending therebetween, the outlet port being located in a side wall of the injection means a fixed, predetermined distance proximal of a closed distal end, the injection means cooperating with the tubular introducer sheath as a guide;

(c) the injection means including indicator means for establishing when the outlet port is located in the dermal layer but external to the blood vessel; and

(d) means coupled to the hemostatic agent injection means for introducing a hemostatic agent under pressure at the inlet port.

14. The apparatus as in claim 13 wherein the tubular hemostatic agent injection means includes a second lumen of a size to accept the tubular introducer sheath therein, the tubular hemostatic agent injection means being slidable about the tubular introducer sheath.

15. The apparatus as in claim 13 wherein the tubular hemostatic introducer comprises an obturator sized to slide within the lumen of the tubular introducer sheath.

16. The apparatus as in claim 15 wherein the obturator includes an expansible balloon member affixed to an exterior surface of the obturator at a location distal of the outlet port, the balloon, when inflated, preventing entrance of the outlet port into the patient'"'"'s blood vessel.

17. The apparatus as in claim 13 wherein the indicator means comprises an arterial blood pressure sensing device.