Apparatus and method for sealing vascular punctures

• US 6,063,085 A
• Filed: 10/23/1995
• Issued: 05/16/2000
• Est. Priority Date: 04/23/1992
• Status: Expired

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schankereli, Kemal, Holman, Thomas, Tay, Sew Wah, Mische, Hans
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US08/537,902
• Time in Patent Office: 1,667 Days
• Field of Search: 606/27, 606/32, 606/37, 606/38, 606/40, 606/41, 606/45-52, 606/191, 606/192, 606/194, 606/195, 606/198, 606/216, 604/900.53, 507/115, 128/638, 128/639, 128/642, 128/661.8, 128/661.09, 128/662.01, 128/662.03, 128/662.05, 128/662.06, 128/DIG. 8, 128/DIG. 22, 600/372, 600/373, 600/374, 600/455, 600/454, 600/453
• US Class Current: 606/50
• 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 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

An apparatus for closing and sealing a vascular puncture is connected to an energy supply such that heat is generated in, or thermally conducted to, the tissue, thereby thermally fusing the vascular tissue together. The method for closing and sealing a vascular puncture comprises applying radio frequency or other energy to the tissue, the energy being sufficient to thermally fuse the tissue together, thus sealing the puncture. Embodiments of depth finding and guiding devices, as well as blood vessel occluders, are also disclosed.

Claims

1. A method of sealing a vascular opening comprising the steps of:

a) percutaneously inserting a probe adjacent to the vascular opening over a guiding element extending from the vessel through the vascular opening;

b) conducting energy from said probe directly to tissue adjacent the probe in an amount sufficient to cauterize said tissue to thereby close said vascular opening; and

c) removing said probe.

2. The method of claim 1 wherein the step of conducting energy comprises conducting thermal energy from said probe tip to the tissue.

3. The method of claim 1 wherein the step of conducting energy comprises conducting electrical energy to the tissue.

4. The method of claim 3 wherein the step of conducting electrical energy comprises conducting alternating current electrical energy to the tissue.

5. The method of claim 4 wherein the step of conducting alternating current electrical energy to the tissue comprises conducting radio frequency energy.

6. The method of claim 4 wherein the step of conducting alternating current electrical energy to the tissue comprises conducting an alternating current having a frequency between 25 kHz and 1,000 kHz.

7. The method of claim 4 wherein the step of conducting alternating current electrical energy comprises conducting microwave energy to cauterize the tissue.

8. The method of claim 3 wherein the step of conducting electrical energy comprises conducting direct current electrical energy to the tissue.

9. The method of claim 8 wherein the step of conducting direct current electrical energy comprises conducting direct current electrical energy in pulsed form.

10. The method of claim 3 wherein the step of conducting electrical energy comprises conducting electrical energy through bipolar electrodes.

11. The method of claim 3 wherein the step of conducting electrical energy comprises conducting electrical energy through a monopolar electrode.

12. The method of claim 1 wherein the probe includes a lumen from a distal end of the probe to a point that will be outside of the body when the probe is in place to seal the vascular opening, and blood flows through the lumen during the sealing process, cessation of flowing blood being indicative of completion of the sealing process.

13. The method of claim 1 further comprising the step of spreading subcutaneous tissue adjacent the vascular opening away from the vascular opening.

14. The method of claim 1 further comprising conducting energy from the probe to the tissue while the guiding element extends through the vascular opening.

15. The method of claim 14, wherein after the steps of conducting energy and removing the probe, the method further comprises the step of removing the guiding element from the vessel, leaving a small hole that clots over to finish closing the vascular opening.

16. The method of claim 14, wherein after the steps of conducting energy and removing the probe, the method further comprises removing the guiding element from the vessel, and the vessel tissue further constricting to finish closing the vascular opening.

17. The method of claim 14, wherein after the step of conducting energy and prior to removing the probe, the method further comprises removing the guiding element from the vessel and conducting additional energy from the probe to the tissue surrounding the probe to finish closing the vascular opening.

18. The method of claim 1 further comprising the step of using an ultrasound system to verify that the probe is adjacent the vascular opening.

19. The method of claim 1 wherein the vascular opening comprises an opening remaining after a catheterization procedure.

20. The method of claim 1 wherein the guiding element extends through the vascular opening in a manner such that the depth of the vascular opening in relationship to the extending portion of the guiding element is known and the method comprises guiding the cautery device to a depth so as to be properly located with respect to the vascular opening by reference to the known relationship between the depth of the vascular opening and the guiding element.

21. A method of using radio frequency energy to close a vascular puncture surrounded by vascular tissue comprising the steps of:

a) guiding a cautery device to the vascular puncture, said cautery device comprising at least one electrode connected to a radio frequency energy source, said electrode being guided into direct contact with the vascular tissue; and

b) supplying radio frequency energy to the electrode while the electrode is in contact with the vascular tissue, thereby delivering radio frequency energy to the vascular tissue, thereby causing the vascular tissue surrounding the puncture to fuse together to close the opening without blocking flow through the vessel.

22. The method of claim 21, wherein the cautery device includes a lumen therein and is guided to the site of the vascular puncture by passing the lumen over a guiding element extending from the vascular puncture.

23. The method of claim 21, further comprising guiding the cautery device to the vascular puncture using a Doppler flow detection system.

24. The method of claim 23, wherein the step of guiding the cautery devices comprises using a cautery device equipped with the Doppler flow detection system on a distal portion thereof.

25. The method of claim 23, wherein the method comprises first guiding a guiding element equipped with a Doppler flow detection system to the vascular puncture aided by the Doppler flow detection system and then guiding the cautery device to the site of the vascular puncture using said guiding element.

26. A method of determining the depth of a percutaneous vascular wall having a puncture therein comprising the steps of:

a) providing an elongated member having

i) a lumen therein,

ii) a port in the side thereof in fluid communication with the lumen, and

iii) an exit opening of the lumen proximal of the port;

b) advancing said elongated member through the puncture and into the vessel;

c) monitoring the exit opening for blood flow, indicative of whether the side port is within the vessel or at or outside of the vascular wall; and

d) thus ascertaining the depth of the vascular wall.

27. The method of claim 26, wherein the step of providing an elongated member having a lumen therein comprises providing an elongated member having a lumen extending to the distal end of the elongated member and a guide wire threaded through the lumen.

28. The method of claim 27, wherein the guide wire has an enlarged cross-section at its distal end which is larger in diameter than the distal end of said lumen and the method includes the step of blocking flow into the distal end of the lumen by use of the enlarged cross-section at the distal end of the guide wire.

29. The method of claim 27, wherein the lumen has a cross-section from the location of the side port to the exit opening of the lumen larger than the cross-section at the distal end of the lumen and the method comprises using the guide wire to plug the distal end of the lumen and blood entering the port and flowing out of the exit opening.

30. The method of claim 27, wherein the proximal end of the elongated member is attached to the distal end of a dilating member and the method comprises percutaneously inserting the dilating member to the depth of the vessel to spread subcutaneous tissue above the puncture site.

31. The method of claim 30, further comprising sliding a cautery sheath over the dilating member and withdrawing the dilating member from the tissue, leaving the elongated member extending into the vessel through the puncture and the cautery sheath spreading the tissue away from the elongated member.

32. The method of claim 26, wherein the step of providing an elongated member having a lumen comprises providing an elongated member having a lumen closed at the distal end of the elongated member.

33. The method of claim 26, wherein the elongated member further includes indicia on the side thereof proximal of the port and the method further comprises the step of using the indicia to indicate the depth of the vascular wall.

34. The method of claim 26, wherein the step of providing an elongated member having a lumen with an exit opening proximal of the port comprises providing an elongated member having a lumen with the exit opening formed in the side of the elongated member.

35. The method of claim 26, wherein the step of ascertaining the depth of the vascular wall includes noting the relative position of the elongated member and the skin surface when the blood just stops flowing through the lumen during removal of the elongated member from the vessel.