Apparatus and method for sealing vascular punctures

• US 5,507,744 A
• Filed: 04/30/1993
• Issued: 04/16/1996
• Est. Priority Date: 04/23/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schankereli, Kemal, Holman, Thomas, Mische, Hans, Tay, Sew-Wah
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/055,634
• Time in Patent Office: 1,082 Days
• Field of Search: 128/638, 128/639, 128/642, 128/898, 128/DIG. 8, 128/DIG. 22, 607/115, 606/191, 606/192, 606/194, 606/195, 606/198, 606/213, 606/215, 606/216, 606/27, 606/32, 606/37, 606/38, 606/40, 606/41, 606/45-52, 604/900
• 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 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 in a vessel within a body comprising the steps of:

a) percutaneously inserting a probe adjacent to the vascular opening and placing a tip of the probe in direct contact with vascular tissue surrounding the vascular opening, the probe including a lumen from its distal end to a point outside of the body when the probe is in place to seal the vascular opening;

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

c) watching blood flowing from the lumen while energy is conducted to the vascular tissue, and determining that the vascular opening is closed by the cessation of blood flowing from the lumen; and

d) 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 to the tissue comprises conducting radio frequency energy.

6. The method of claim 4 wherein the step of conducting alternating current 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 energy comprises conducting direct current 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 further comprising the step of spreading subcutaneous tissue adjacent the vascular opening away from the vascular opening.

13. An apparatus for sealing an opening in a vessel wall, the vessel wall comprising vascular tissue, comprising:

a) an energy delivery probe adapted to conduct energy directly to the vascular tissue surrounding said opening, a portion of the probe being configured to contact the vascular tissue surrounding said opening, and

b) means for spreading subcutaneous tissue superficial to the vessel wall, said spreading means being capable of spreading the subcutaneous tissue to an opening dimension that is both larger than the opening in the vessel wall and larger than the dimension of the portion of the energy delivery probe used to contact the vascular tissue surrounding the opening.

14. A method of treating a percutaneous opening in a wall of a vessel within a body, the vessel wall comprising tissue surrounding a lumen, the method comprising the steps of:

a) advancing a shaft having an inflatable balloon at a distal end thereof through the opening into the lumen of the vessel;

b) inflating said balloon to a size sufficiently large to occlude the opening;

c) retracting said balloon until the balloon abuts the tissue surrounding the opening in the vessel, thereby occluding the opening;

d) inserting a distal portion of a cautery device into the body, said distal portion of said cautery device comprising forceps;

e) grasping and pulling together the tissue surrounding the opening with the forceps, the inflated balloon providing a back stop for the forceps;

f) deflating the balloon and withdrawing the shaft from the vessel after the tissue has been grasped and pulled together by the forceps; and

g) applying radio frequency energy to the tissue surrounding the opening, said energy being sufficient to thermally fuse and seal the tissue together.

15. An apparatus for the percutaneous treatment of a vascular puncture, said apparatus being adapted to percutaneously apply an electrical current to tissue proximate said vascular puncture to thermally seal said vascular puncture, comprising:

a) a cautery instrument for percutaneously sealing said vascular puncture, said instrument having

i) an elongated guide lumen for receiving an elongated shaft therethrough, and

ii) at least one electrode; and

b) an elongated shaft for percutaneously guiding said electrode to said vascular puncture, said elongated shaft having a distal end comprising an inflatable balloon sized and shaped to occlude said vascular puncture and a proximal end comprising means for inflating said balloon.

16. The apparatus of claim 15 wherein said cautery instrument further comprises a gripping handle and a pivotable actuation mechanism for actuating said electrode from a first position to a second position.

17. The apparatus of claim 15 wherein said cautery instrument further comprises a gripping handle and a rack and pinion actuation mechanism for actuating said electrode from a first position to a second position.

18. The apparatus of claim 15 wherein said cautery instrument further comprises a gripping handle and an actuation mechanism having a wedge which acts against an inclined plane for actuating said electrode from a first position to a second position.

19. An apparatus for the percutaneous treatment of a vascular puncture, said apparatus being adapted to percutaneously apply an electrical current to tissue proximate said vascular puncture to thermally seal said vascular puncture, comprising:

a) a cautery instrument for percutaneously sealing said vascular puncture, said instrument having

i) an elongated guide lumen for receiving an elongated shaft therethrough, and

ii) at least one electrode; and

b) an elongated shaft for percutaneously guiding said electrode to said vascular puncture, said elongated shaft having a distal end comprising a positioning mechanism insertable into a vessel lumen, said positioning mechanism configured to anchor the distal end of said elongated shaft inside said vascular puncture.

20. The apparatus of claim 19 wherein said elongated shaft further comprises markings thereon to measure a depth of said vascular puncture from a skin level.

21. The apparatus of claim 19 wherein the cautery instrument further comprises an elongated tubular retaining housing substantially surrounding said guide lumen and said electrode.

22. The apparatus of claim 19 wherein said electrode is an elongated electrode, external to and substantially parallel with said guide lumen.

23. An apparatus for percutaneously sealing a vascular puncture with an electrical current, said apparatus being adapted to percutaneously apply an electrical current to tissue surrounding said vascular puncture for the purpose of thermally sealing said vascular puncture, said apparatus comprising:

a) a cautery instrument for percutaneously sealing said vascular puncture, said instrument having

i) at least two movable electrodes, each electrode having a proximal end adapted to connect to a radio frequency power source and a distal end adapted to engage vascular tissue surrounding said vascular puncture and being movable from a first position to a second position;

ii) an elongated interior guide lumen for receiving an elongated shaft to guide said electrodes to said vascular puncture;

iii) an elongated tubular retaining housing substantially surrounding said electrodes and said guide lumen, said tubular retaining housing having an open distal end to allow for movement of said electrodes from said first position wherein said electrodes are contained within said tubular retaining housing to said second position wherein the distal end of each of said electrodes extends beyond the distal end of said tubular retaining housing;

b) an elongated shaft for percutaneously guiding said electrodes to said vascular puncture; and

c) a balloon occluder assembly which includes said elongated shaft, said elongated shaft having a proximal end and a distal end, said distal end of said elongated shaft comprising an inflatable balloon and said proximal end connected to an inflation mechanism, said balloon occluder assembly adapted to be inserted into said interior guide lumen and to percutaneously guide each of said electrodes to said vascular puncture.

24. The apparatus of claim 23 wherein said elongated shaft comprises a T-shaped occluder, said T-shaped occluder adapted to be inserted into said interior guide lumen for percutaneously guiding each of said electrodes to said vascular puncture.

25. The apparatus of claim 23 wherein said electrodes are bipolar electrodes.

26. The apparatus of claim 25 wherein said bipolar electrodes are outwardly biased forceps for grasping tissue proximate the vascular puncture.

27. The apparatus of claim 26 wherein said outwardly biased forceps have a serrated distal end for grasping tissue proximate said vascular puncture.

28. The apparatus of claim 23 further comprising a grounding pad to be positioned beneath a patient for completing an electrical circuit with said cautery instrument.

29. An apparatus for the percutaneous treatment of a vascular puncture using radio frequency energy, said apparatus comprising:

a) a pair of substantially parallel elongated bipolar electrodes, each of said electrodes having a distal end for engaging tissue proximate said vascular puncture and a proximal end connectable to a radio frequency power source;

b) an elongated tubular retaining housing substantially surrounding said electrodes and comprising an elongated interior guide lumen substantially parallel to said electrodes for receiving a guiding device therethrough to guide said electrodes to said vascular puncture;

the housing having at least one internal wall separating said guide lumen from said electrodes, said apparatus being adapted to apply an electrical current to tissue surrounding said vascular puncture for the purpose of thermally sealing said vascular puncture.

30. The apparatus of claim 29 wherein said electrodes are movable from a first position to a second position and said tubular retaining housing has an open distal end to allow for movement of said electrodes from said first position wherein said electrodes are contained within said tubular retaining housing to said second position wherein the distal end of each of said electrodes extends beyond the open distal end of said tubular retaining housing.

31. The apparatus of claim 29 wherein said housing has an open distal end and an open proximal end, said apparatus further comprising a guiding device insertable into and through said interior guide lumen for percutaneously guiding said electrodes to said vascular puncture, said guiding device having a distal end extending beyond said open distal end of said tubular retaining housing and insertable into a vessel lumen and a proximal end extendable beyond a proximal end of said tubular retaining housing.

32. The apparatus of claim 29 wherein said housing comprises triple lumen tubing.

33. The apparatus of claim 29 wherein said internal wall comprises a separate elongated tube having said guide lumen therethrough.

34. The apparatus of claim 29 wherein said apparatus further comprises a proximal end having a gripping handle for grasping said apparatus.

35. The apparatus of claim 34 wherein said apparatus further comprises an actuation mechanism having an actuator element, movement of said actuator element causing each of said electrode to move from said first position to said second position.

36. A method for percutaneously sealing a vascular puncture using radio frequency energy comprising:

a) using an elongated shaft to percutaneously locate said vascular puncture;

b) percutaneously guiding a radio frequency energy cautery instrument to said vascular puncture using said elongated shaft; and

c) generating a cauterizing discharge from said cautery instrument to tissue proximate said vascular puncture sufficient to thermally seal said vascular puncture.

37. The method of claim 36 wherein the step of using said elongated shaft to percutaneously locate said vascular puncture further includes the step of temporarily occluding said vascular puncture using said elongated shaft wherein said elongated shaft has a distal end comprising an inflatable balloon and wherein said balloon is inflated and retracted inside said vascular puncture until said balloon abuts said puncture, thereby preventing fluid loss from said puncture.

38. The method of claim 36 wherein the step of using an elongated shaft to percutaneously locate said vascular puncture further includes the step of determining the depth of said vascular puncture by advancing a distal portion of said elongated shaft into a vessel lumen, said shaft having a series of markings thereon for determining depth.

39. The method of claim 36 wherein the cautery instrument comprises an interior guide lumen and the step of using an elongated shaft to percutaneously locate said vascular puncture further comprises using an elongated shaft having a proximal end and a distal end, said distal end of said elongated shaft comprising an inflatable balloon and said proximal end connected to an inflation mechanism, said balloon being adapted to be inserted into said interior guide lumen and to percutaneously guide said cautery instrument to said vascular puncture.

40. The method of claim 36 wherein the step of percutaneously guiding a radio frequency energy cautery instrument to said vascular puncture using said elongated shaft further comprises using a cautery instrument having an elongated interior guide lumen for receiving said elongated shaft therethrough and at least one substantially parallel elongated electrode external said guide lumen for applying electrical current to said tissue proximate said vascular puncture.

41. A method for percutaneously sealing a vascular puncture comprising:

a) guiding a cautery instrument to the vascular puncture, the cautery instrument having

i) a distal end comprising a pair of forceps which act as electrodes for grasping tissue,

ii) a proximal end for gripping by a user,

iii) an elongated interior guide lumen between and substantially parallel to said forceps for receiving an elongate guiding device to guide said forceps to said vascular puncture, and

iv) an elongated tubular retaining housing surrounding said forceps and said guide lumen, and having an open distal end;

b) actuating said forceps from a first position wherein said forceps are contained substantially within said tubular retaining housing to a second position wherein said forceps extend beyond said tubular retaining housing and grasping tissue proximate said vascular puncture; and

c) generating a cauterizing discharge to said tissue proximate said vascular puncture to thermally seal said vascular puncture.

42. A method of using radio frequency energy to seal a vascular puncture comprising:

a) using a guiding assembly to locate said vascular puncture;

b) guiding a cautery instrument having a cauterizing distal end to said vascular puncture using said guiding assembly;

c) engaging tissue proximate said vascular puncture with said cauterizing distal end;

d) energizing said instrument with said radio frequency energy to thermally seal said vascular puncture.

43. A combination of an apparatus for sealing a vascular opening and a guide to direct the apparatus to the vascular opening, wherein the combination comprises:

a) a probe sized to be percutaneously inserted adjacent the vascular opening;

b) a connector connected to the probe for connecting the probe to an energy supply source;

c) the probe comprising a conductor configured to conduct energy directly to tissue adjacent the probe to cause heating of tissue surrounding the vascular opening to close said opening; and

d) the guide comprising an elongated member with a lumen therein open at least on its proximal end and a port in a side thereof in fluid communication with said lumen.

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

a) providing a guiding element extending from the vascular puncture;

b) guiding a cautery device comprising a lumen to the vascular puncture by passing the lumen over the guiding element extending from 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

c) 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, the energy being sufficient to cause the vascular tissue surrounding the puncture to fuse together to close the opening.

45. A method of sealing a vascular puncture comprising the steps of:

a) percutaneously inserting a probe having a lumen by inserting the lumen over a guiding element extending from the vascular puncture and placing a tip of the probe in direct contact with vascular tissue surrounding the vascular puncture;

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

c) removing said probe.

46. The method of claim 45 wherein the step of conducting energy comprises conducting energy from the probe to the tissue while the guiding element extends from the vascular puncture.

47. The method of claim 46 wherein after the energy conduction and probe removal, the method further comprises the step of removing the guiding element from the vessel, leaving a hole sufficiently small such that clotting can finish closing the vascular puncture.

48. The method of claim 46 wherein after the energy conduction and probe removal, the method further comprises the of removing the guiding element from the vessel, leaving a hole sufficiently small such that vessel tissue contraction can finish closing the vascular puncture.