Percutaneous hemostasis device

• US 5,984,950 A
• Filed: 07/20/1998
• Issued: 11/16/1999
• Est. Priority Date: 12/23/1996
• Status: Expired due to Term

• Current Assignee: Allen Family Trust, Andrew H. Cragg, Boston Scientific Scimed (Boston Scientific Corporation), Bruce Feuchter, FirstMark II LP (FirstMark Capital, LLC), Geoffrey O. Hartzler, George Wallace, Pacific Venture Group II, L.P., PVG Associates II, L.P., Kingsbury Capital Partners, L.P. III (Timothy J. Wollaeger, MBA), Kingsbury Capital Partners, L.P. IV (Timothy J. Wollaeger, MBA)
• Original Assignee: Sub-Q, Inc. (Merit Medical Systems, Inc.)
• Inventors: Cragg, Andrew H., Brenneman, Rodney
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Trinh, Vikki
• Application Number:
  US09/119,268
• Time in Patent Office: 484 Days
• Field of Search: 606/213, 606/216, 606/139, 606/151-153, 606/155, 606/220, 606/221, 606/217, 606/215
• US Class Current: 606/216
• 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 2017/00637 for sealing trocar wounds through abdominal wall

Abstract

A vascular hemostasis device comprises a shaft coaially received within a hollow tube, and having a distal end formed with an opposed pair of resilient grasping prongs. The tube has an open distal end that may be situated percutaneously adjacent a vascular puncture site. The shaft and the tube are axially movable with respect to one another, so that the distal end of the shaft may be selectively extended from and partially retracted into the distal end of the tube by means of an actuation member attached to the shaft. When the distal shaft end is in its extended position, the prongs are exposed from the distal end of the tube, and they resiliently expand to an open position. When the distal shaft end is moved to its retracted position, the prongs are partially retracted into the distal end of the tube, radially contracting them to a closed position. In contracting, the prongs grasp and gather tissue adjacent the puncture site to obstruct bleeding therefrom. In a first embodiment, the prongs are on a distal end portion, of resorbable material, that is detachable from the body of the shaft. The tube is a sleeve through which the shaft is slidably disposed, the sleeve being axially received within a trocar that is installed percutaneously to the puncture site. A second preferred embodiment includes a unitary shaft with the prongs at the distal end. The tube in which the shaft is axially disposed is the trocar itself.

Claims

1. A method of promoting hemostasis at a perforation or puncture site in a subcutaneous lumen, the method comprising the steps of:

providing percutaneous access to the site through a cannula;

providing an elongate shaft having a distal end portion terminating in at least one opposed pair of resilient prongs;

inserting the elongate shaft into the cannula over a guidewire;

grasping tissue with the resilient prongs;

gathering the grasped tissue together with the resilient prongs to substantially inhibit flow of blood from the site; and

delivering an agent to the site to further inhibit the flow of blood from the site.

2. The method of claim 1, wherein the agent is a hemostasis promoting agent.

3. The method of claim 1, wherein the agent is a tissue adhesive.

4. The method of claim 1, wherein the agent is a coagulation accelerant.

5. The method of claim 1, wherein the step of delivering the agent includes withdrawing the guidewire from the elongate shaft and injecting the agent through a lumen of the elongate shaft.

6. The method of claim 1, wherein the step of delivering the agent includes injecting the agent through a lumen of the cannula.

7. A method of promoting hemostasis at a perforation or puncture site in a subcutaneous lumen, the method comprising the steps of:

providing percutaneous access to the site through a cannula;

providing an elongate shaft having a distal end portion terminating in at least one opposed pair of resilient prongs;

inserting the elongate shaft into the cannula;

grasping tissue with the resilient prongs;

gathering the grasped tissue together with the resilient prongs to substantially inhibit flow of blood from the site;

delivering an agent to the site to further inhibit the flow of blood from the site; and

injecting a contrasting dye to the site for visualization.

8. A method of promoting hemostasis at a perforation or puncture site in a subcutaneous lumen, the method comprising the steps of:

providing percutaneous access to the site through a cannula;

providing an elongate shaft having a distal end portion terminating in at least one opposed pair of resilient prongs;

inserting the elongate shaft through the cannula;

grasping tissue with the resilient prongs;

gathering the grasped tissue together with the resilient prongs to substantially inhibit flow of blood from the site;

inserting an optical fiber to the site; and

delivering light energy through the optical fiber to promote hemostasis at the site.

9. The method of claim 8, wherein the elongated shaft is inserted over a guidewire and further comprising a step of withdrawing the guidewire from the elongate shaft and inserting the optical fiber through a lumen of the shaft.

10. The method of claim 8, wherein the optical fiber is inserted to the site through the cannula along one side of the shaft.

11. The method of claim 8, wherein the light energy delivered to the site is laser light energy.

12. A percutaneous vascular hemostasis device comprising:

an elongate hollow tube having an open distal end;

an elongate shaft disposed coaxially within the tube and having a proximal end portion and a distal end portion, the distal end portion terminating in at least one opposed pair of resilient prongs, whereby the shaft and the tube are axially movable with respect to one another so that the distal end portion of the shaft may be selectively extended from and partially retracted into the distal end of the tube, and the elongate shaft is formed of a conductive material;

an actuation member attached to the proximal end portion of the shaft for moving the prongs from a grasping position in which the prongs are spaced from one another to grasp tissue to a retracted position in which the grasped tissue is gathered together, the actuation member moving the prongs radially with respect to the elongated shaft from the grasping position to the retracted position; and

an electrocautery generator connected to the elongate shaft for delivery of coagulation energy to the distal end of the shaft.

13. The percutaneous vascular hemostasis device according to claim 12, wherein the conductive shaft is coated with an insulating material so that only the distal end of the shaft delivers coagulation energy to tissue.

14. The percutaneous vascular hemostasis device according to claim 12, wherein each of the resilient prongs have an inwardly-turned end.

15. A method of promoting hemostasis at a perforation or puncture site in a subcutaneous lumen, comprising the steps of:

providing percutaneous access to the site through a surgical trocar, the trocar having open distal and proximal ends, the distal end being disposed within the lumen through the site;

providing an elongated shaft having a proximal end portion and a distal end portion, the distal end portion terminating in at least one opposed pair of resilient prongs, each of the prongs having an inwardly-turned end;

installing the shaft axially into the trocar so that the prongs reside within the trocar near the distal end of the trocar;

withdrawing the trocar and the shaft together a sufficient distance to place the distal end of the trocar external to the lumen and adjacent to the site;

withdrawing the trocar proximally with respect to the shaft a sufficient distance to expose the prongs, whereby the prongs expand radially to an open position external to the lumen; and

moving the trocar distally with respect to the shaft so as to retract the prongs partially into the distal end of the trocar, whereby the prongs are radially contracted to a closed position so as to grasp and gather together tissue adjacent the site external to the lumen, whereby the flow of blood from the site is substantially inhibited.

16. The method of claims 15, further comprising the step of:

when hemostasis has been achieved, withdrawing the shaft from the trocar.

17. The method of claim 16, wherein the step of withdrawing the shaft from the trocar comprises the steps of:

moving the trocar proximally with respect to the shaft so as to expose the prongs, whereby the prongs expand radially to their grasping position; and

pulling the shaft proximally through the trocar.

18. The method of claim 15, wherein the distal end portion of the shaft is detachable and formed of a bioresorbable material, and wherein the method further comprises the steps of:

detaching the distal end portion of the shaft while the prongs are in their retracted position and grasping the tissue; and

withdrawing the shaft from the trocar while leaving the detachable distal end portion in place adjacent the site until it is resorbed.