Apparatus and method for sealing vascular punctures

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.

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. 
     
     
       36. The method of  claim 1  wherein the probe comprises a balloon. 
     
     
       37. The method of  claim 21  wherein the cautery device comprises a balloon. 
     
     
       38. The method of  claim 26  wherein the elongated member comprises a balloon. 
     
     
       39. A method of sealing a vascular opening in a vessel, the method comprising:
   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 the probe directly to tissue adjacent the probe in an amount sufficient to cauterize the tissue to thereby close the vascular opening; and        c )  removing the probe.     
     
     
       40. The method of  claim 39 , wherein the sealing of the opening is performed without blocking flow through the vessel. 
     
     
       41. The method of  claim 39 , further including verifying the position of the probe in relation to the vascular opening using ultrasound. 
     
     
       42. The method of  claim 39  wherein the probe comprises a balloon. 
     
     
       43. A method of sealing a vascular opening comprising:
   a )  percutaneously guiding a cautery device over a guiding element extending through the vascular opening to a position adjacent the vascular opening;        b )  delivering energy from the cautery device to tissue adjacent the vascular opening in an amount sufficient to cauterize the tissue to thereby close the vascular opening; and        c )  removing the cautery device from the position near the vascular opening.     
     
     
       44. The method of  claim 43 , wherein the guiding step includes using ultrasound to verify a spatial relationship between the cautery device and the vascular opening. 
     
     
       45. The method of  claim 43 , further including verifying the position of the cautery device in relation to the vascular opening using ultrasound. 
     
     
       46. The method of  claim 43 , wherein the sealing of the opening is performed without blocking flow through the vessel. 
     
     
       47. The method of  claim 43  wherein the cautery device comprises a balloon. 
     
     
       48. A method of sealing a vascular opening, the method comprising:
   a )  percutaneously positioning a cautery device in a position adjacent the vascular opening by guiding the cautery device over a guiding element extending through the vascular opening;        b )  delivering energy from the cautery device to tissue adjacent the vascular opening in an amount sufficient to thereby cause tissue adjacent the vascular opening to fuse together to close the opening; and        c )  removing the cautery device from the position near the vascular opening.     
     
     
       49. The method of  claim 48 , wherein the guiding step includes using ultrasound to verify a spatial relationship between the cautery device and the vascular opening. 
     
     
       50. The method of  claim 48 , further including determining the position of the vascular opening in relation to the cautery device using ultrasound. 
     
     
       51. The method of  claim 50 , wherein the position of the vascular opening in relation to the cautery device is determined prior to delivering energy. 
     
     
       52. The method of  claim 48 , further including verifying a spatial relationship between the vascular opening and the cautery device using ultrasound during the step of delivering energy. 
     
     
       53. The method of  claim 48 , wherein the sealing of the opening is performed without blocking flow through the vessel. 
     
     
       54. The method of  claim 48 , further including verifying a spatial relationship between the vascular opening and the cautery device using ultrasound. 
     
     
       55. The method of  claim 48  wherein the cautery device comprises a balloon. 
     
     
       56. A method of sealing a vascular opening, the method comprising:
   a )  percutaneously positioning a cautery device over a guiding element passing through the vascular opening in a position adjacent the vascular opening using a position indicating mechanism;        b )  delivering energy from the cautery device to bodily material adjacent to the vascular opening, resulting in local heating of the bodily material adjacent to the vascular opening to achieve hemostasis;        c )  removing the cautery device from near the vascular opening.     
     
     
       57. The method of  claim 56 , wherein the position indicating mechanism comprises an ultrasound device. 
     
     
       58. The method of  claim 56 , wherein the position indicating mechanism comprises a Doppler flow detection system. 
     
     
       59. The method of  claim 56 , wherein the position indicating mechanism comprises a flow anemometer. 
     
     
       60. The method of  claim 56 , wherein the vascular wall includes an intima layer, and the local heating of bodily material adjacent to the vascular opening to achieve hemostasis occurs without substantially heating the intima layer of the vascular wall. 
     
     
       61. The method of  claim 56  wherein the cautery device comprises a balloon. 
     
     
       62. A method of sealing a vascular opening, the method comprising:
   a )  guiding a cautery device to a position near the vascular opening using an ultrasound device to verify a spatial relationship between the opening and the device; and        b )  delivering energy from the cautery device to tissue adjacent the vascular opening in an amount sufficient to thereby cause tissue adjacent the vascular opening to fuse together to close the opening.     
     
     
       63. The method of  claim 62  wherein the cautery device comprises a balloon. 
     
     
       64. A method of sealing a vascular opening in a vascular wall, the method comprising:
   a )  positioning a cautery device in a position near the vascular opening using ultrasound to verify a spatial relationship between the device and the opening;        b )  delivering energy from the cautery device to tissue adjacent the vascular opening in an amount sufficient to thereby cause the vascular tissue to fuse together to close the opening; and        c )  removing the energy delivering means from the position near the vascular opening.     
     
     
       65. The method of  claim 64  wherein the cautery device comprises a balloon. 
     
     
       66. A method of sealing a vascular opening in a vascular wall, the method comprising:
   a )  verifying a spatial relationship between the vascular opening and a cautery device using ultrasound;        b )  positioning a cautery device in a position near the vascular opening using ultrasound;        c )  delivering energy from the cautery device to tissue adjacent the vascular opening in an amount sufficient to thereby cause the vascular tissue to fuse together to close the opening; and        d )  removing the cautery device from the position near the vascular opening.     
     
     
       67. The method of  claim 66  wherein the cautery device comprises a balloon. 
     
     
       68. A method of sealing a vascular opening, the method comprising:
   a )  positioning an energy delivering device in a position adjacent the vascular opening by guiding the energy delivering device over a guiding element extending through the vascular opening;        b )  delivering energy from the energy delivering device to tissue adjacent the vascular opening in an amount sufficient to thereby cause the vascular tissue to fuse together to close the opening; and        c )  removing the energy delivering device from the position near the vascular opening.     
     
     
       69. The method of  claim 68  wherein the cautery device comprises a balloon.