Method and apparatus for treatment of atrial fibrillation

• US 20020183738A1
• Filed: 03/14/2002
• Published: 12/05/2002
• Est. Priority Date: 06/02/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Kermode, James R., Mueller, Richard L., Tom, Curtis P., Murphy-Chutorian, Douglas, Chee, U. Hiram
• Granted Patent: US 7,147,633 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 17/282 Jaws
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

Methods and apparatus of embodiments of the invention are adapted to treat tissue inside a patient'"'"'s body. Aspects of the invention can be used in a wide variety of applications, but certain embodiments provide minimally invasive alternatives for treating atrial fibrillation by delivering a tissue-damaging agent to selected areas of the heart. One exemplary embodiment of the invention provides a method of treating cardiac arrhythmia. This method includes positioning a distal tissue-contacting portion of a body in surface contact with a tissue surface of cardiac tissue; detecting the surface contact between the tissue-contacting portion and the tissue surface; and thereafter, injecting a tissue-ablating agent into the cardiac tissue through the tissue-contacting portion of the body.

Claims

1. A medical device for treating patient tissue comprising:

a fluid reservoir;

a first tissue contacting member adapted to be manipulated into contact with a surface of a target tissue, the first tissue contacting member having a body, first and second tissue-contacting surfaces spaced from one another to define a gap therebetween, and a recess proximate to the gap; and

a first fluid delivery conduit in fluid communication with the reservoir and having a plurality of outlet ports, the first fluid delivery conduit having a length received in the recess with the outlet ports oriented toward, but spaced from, the gap.

2. The medical device of claim 1 further comprising a second tissue contacting member having a body and a tissue-contacting surface, the second tissue contacting member being operatively associated with the first tissue contacting member to permit movement between an open configuration and a closed configuration, the tissue-contacting surfaces of the first tissue contacting members being oriented generally toward the second tissue contacting member in the closed configuration.

3. The medical device of claim 1 further comprising:

a second tissue contacting member having a body, first and second tissue-contacting surfaces spaced from one another to define a second gap therebetween, and a second recess proximate to the gap, the second tissue contacting member being operatively associated with the first tissue contacting member to permit movement between an open configuration and a closed configuration, the tissue-contacting surfaces of the first and second tissue contacting members being oriented generally toward one another in the closed configuration; and

a second fluid delivery conduit in fluid communication with the reservoir and having a plurality of outlet ports, the second fluid delivery conduit having a length received in the second recess with the outlet ports oriented toward, but spaced from, the second gap.

4. The medical device of claim 3 further comprising an elongate body sized to be introduced into a thoracic cavity through an intercostal incision, the first tissue contacting member and the second tissue contacting member being disposed adjacent a distal end of the body, and a manually operable actuator spaced proximally from the distal end of the body and adapted to move the first and second tissue contacting members between the open and closed configurations.

5. The medical device of claim 1 wherein the first tissue contacting member carries a tissue contacting sensor.

6. The medical device of claim 5 wherein the contact sensor comprises a pair of electrodes, one electrode of the pair being carried on the first tissue-contacting surface and the other electrode of the pair being carried on the second tissue-contacting surface.

7. The medical device of claim 1 wherein the ports of the conduit are spaced a distance from a plane extending between the first and second tissue-contacting surfaces.

8. The medical device of claim 1 further comprising a pressure control in fluid communication with the reservoir, the pressure control being operable to establish an elevated pressure within the fluid delivery conduit sufficient to propel a fluid in the fluid reservoir through the outlet ports to define a plurality of spaced-apart fluid jets capable of penetrating a target tissue to a gap of at least about 2 mm.

9. The medical device of claim 8 wherein the pressure control is operable to establish an elevated delivery pressure of about 600-2000 psi.

10. The medical device of claim 8 wherein the pressure control is operable to define the fluid jets capable of penetrating an entire thickness of a patient'"'"'s myocardium.

11. The medical device of claim 1 further comprising a tissue-ablating agent in the reservoir, the tissue-ablating agent comprising a fluid selected from the group consisting of alcohols, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, cold ethylene glycol, sodium tetradecyl sulfate, and polyethyleneglycolmonododecylether.

13. The medical device of claim 12 wherein the tissue grasping member carries a tissue contact sensor.

14. The medical device of claim 13 wherein the tissue contact sensor comprises a pair of electrodes.

15. The medical device of claim 12 wherein the first tissue contacting member includes an elongate first recess within which the distal length of the first fluid delivery conduit is received and the second tissue contacting member includes an elongate second recess within which the distal length of the second fluid delivery conduit is received.

16. The medical device of claim 15 wherein the first tissue contacting member has a first tissue-contacting face having a first gap therein, the outlet ports of the first fluid delivery conduit being oriented toward, but spaced from, the first gap, and the second tissue contacting member has a second tissue contacting face having a second gap therein, the outlet ports of the second fluid delivery conduit being oriented toward, but spaced from, the second gap.

18. The medical device of claim 17 wherein the pressure control is operable to establish an elevated delivery pressure of at least about 400 psi.

19. The medical device of claim 17 wherein the pressure control is operable to establish an elevated delivery pressure of about 600-2000 psi.

20. The medical device of claim 17 wherein the pressure control is operable to define the fluid jets capable of penetrating an entire thickness of a patient'"'"'s myocardium.

21. The medical device of claim 17 wherein the tissue-contacting member includes a tissue contact sensor.

22. The medical device of claim 21 wherein the tissue contact sensor is operatively coupled to an EKG display.

23. The medical device of claim 21 wherein the tissue contact sensor comprises at least two electrodes spaced from one another along a tissue-contacting surface of the tissue-contacting member of the body.

24. The medical device of claim 23 wherein the electrodes are operatively coupled to an EKG display

25. The medical device of claim 17 wherein the tissue-contacting member is flexible and adapted to conform to a surface of a target tissue.

26. The medical device of claim 25 wherein the tissue-contacting member has a predetermined curvature in a natural, relaxed state and tends to resiliently return toward the relaxed state when conforming to the surface of the target tissue.

27. The medical device of claim 25 wherein a proximal length of the body is flexible.

28. The medical device of claim 17 wherein the plurality of ports comprises a series of ports aligned along a tissue-contacting surface of the tissue-contacting member of the body.

29. The medical device of claim 17 further comprising a tissue-ablating agent in the reservoir, the tissue-ablating agent comprising a fluid selected from the group consisting of alcohols, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, cold ethylene glycol, sodium tetradecyl sulfate, and polyethyleneglycolmonododecylether.

30. The medical device of claim 17 further comprising a tissue-ablating agent in the reservoir, the tissue-ablating agent comprising a fluid selected from the group consisting of ethanol, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, and cold ethylene glycol.

31. The medical device of claim 17 further comprising a tissue-ablating agent in the reservoir, the tissue-ablating agent being selected to damage tissue into which it is injected, yet permit introduction of excess tissue-ablating agent into the patient'"'"'s bloodstream.

32. The medical device of claim 31 wherein the tissue-ablating agent comprises a fluid selected from the group consisting of ethanol, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, and cold ethylene glycol.

12. A medical device for treating patients tissue comprising:

a fluid reservoir;

a tissue grasping member comprising a first tissue contacting member and an opposed second tissue contacting member, the first and second tissue contacting members being operatively associated with one another and movable between a first configuration wherein they have a first relative orientation adapted to receive the tissue therebetween and a second configuration wherein they have a second relative orientation adapted to grasp tissue therebetween; and

first and second fluid delivery conduits in fluid communication with the reservoir, the first fluid delivery conduit having a distal length carried by the first tissue contacting member and a plurality of outlet ports spaced along that distal length, and the second fluid delivery conduit having a distal length carried by the second tissue contacting member and a plurality of outlet ports spaced along that distal length, the outlet ports of the first and second fluid delivery conduits being oriented generally inwardly toward one another when the tissue grasping member is in the second configuration.

17. A medical device for treating cardiac arrhythmia, comprising:

a fluid reservoir for receiving an injectable tissue-ablating agent;

an elongate body adapted for introduction into a thoracic cavity, the body having a distal tissue-contacting member having a length adapted to lie in contact with a surface of a target tissue;

a plurality of outlet ports spaced along the length of the tissue-contacting member;

a lumen in the body communicating the reservoir with the outlet ports;

a pressure control in fluid communication with the reservoir, the pressure control being operable to establish an elevated pressure within the lumen sufficient to propel the tissue-ablating agent from the fluid supply through the outlet ports to define a plurality of spaced-apart fluid jets capable of penetrating the target tissue to a depth of at least about 2 mm.

33. A method of treating cardiac arrhythmia comprising:

positioning a tissue grasping member adjacent a target tissue of a heart atrium or a pulmonary vein, the target tissue having two spaced-apart wall segments;

moving opposed tissue-contacting members of the tissue grasping member toward one another to deform the target tissue such that the wall segments are moved closer to, but remain spaced from, one another; and

ablating target tissue in contact with the tissue contacting members to create a lesion extending through both wall segments.

35. The method of claim 34 further comprising:

moving the ablating member again;

juxtaposing the two wall segments along a third plane; and

ablating tissue in both wall segments along the third plane with the ablating member to form a lesion along a third length of each wall segment.

36. The method of claim 34 wherein the first and second lengths at least substantially circumscribe the pulmonary vein.

37. The method of claim 34 further comprising repositioning the ablating member and ablating tissue to form at least one additional lesion which, together with the first and second lengths, forms a series of lesions which at least substantially circumscribes the pulmonary vein.

40. The method of claim 39 wherein the tissue-ablating agent is pressurized to a delivery pressure of at least about 400 psi to inject the tissue-ablating agent into the cardiac tissue.

41. The method of claim 39 wherein the tissue-ablating agent is pressurized to a delivery pressure of about 600-2000 psi to inject the tissue-ablating agent into the cardiac tissue.

42. The method of claim 39 wherein the tissue-ablating agent is injected into the cardiac tissue to a depth of at least about 2 mm.

43. The method of claim 39 wherein the tissue-ablating agent is injected into the cardiac tissue at an elevated pressure through a plurality of outlet ports along the tissue-contacting portion.

44. The method of claim 43 wherein the tissue-ablating agent is injected through the outlet ports into the cardiac tissue to a depth of at least about 2 mm.

45. The method of claim 43 wherein the tissue-ablating agent is injected through the outlet ports into the cardiac tissue at a pressure sufficient to penetrate an entire thickness of a patient'"'"'s myocardium

46. The method of claim 39 wherein the tissue-ablating agent comprises a fluid selected from the group consisting of alcohols, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, cold ethylene glycol, sodium tetradecyl sulfate, and polyethyleneglycolmonododecylether.

47. The method of claim 39 wherein the tissue-contacting portion of the body comprises a blunt distal tip of the body having a tissue-contact sensor, the tissue-contact sensor being used to detect the surface contact.

48. The method of claim 39 wherein the tissue-contacting portion of the body comprises an elongate surface of a distal length of the body.

49. The method of claim 48 wherein the tissue-contacting portion includes a plurality of outlet ports, injecting the tissue-ablating agent comprising pressurizing the tissue-ablating agent to a delivery pressure of at least about 600 psi.

50. The method of claim 39 wherein the tissue-contacting portion of the body comprises an elongate surface of a distal length of the body having a tissue-contact sensor, the tissue-contact sensor being used to detect the surface contact.

51. The method of claim 50 wherein the tissue-contacting portion of the body has a curved configuration in a relaxed state, guiding the body further comprising allowing the tissue-contacting portion to relax to conform to the tissue surface.

52. The method of claim 39 wherein the injectate delivery device further comprises a selectively deployable needle, injecting the tissue-damaging agent comprising advancing the needle through the tissue surface into the cardiac tissue and delivering a tissue-damaging fluid through a lumen of the needle.

53. The method of claim 39 wherein detecting surface contact comprises supplying an excitation voltage to a plurality of electrodes positioned on the tissue-contacting portion of the body and measuring a level of at least one current conducted by the plurality of electrodes, wherein the level depends upon a degree of contact between at least two of the electrodes and the tissue surface.

54. The method of claim 53 further comprising displaying an indication of an orientation of the tissue-contacting portion with respect to the tissue surface.

55. The method of claim 53 further comprising displaying an indication of a degree to which the tissue-contacting portion intrudes into the tissue surface.

56. The method of claim 39 wherein surface contact is detected with a plurality of electrodes positioned on the tissue-contacting portion of the body, further comprising measuring an EKG of the cardiac tissue with the electrodes.

34. A method of at least partially electrically isolating a pulmonary vein from a heart atrium having two spaced-apart wall segments, comprising:

juxtaposing the two wall segments along a first plane;

ablating tissue in both wall segments along the first plane with an ablating member to form a lesion along a first length of each wall segment;

moving the ablating member;

juxtaposing the two wall segments along a second plane; and

ablating tissue in both wall segments along the second plane with the ablating member to form a lesion along a second length of each wall segment, the second length adjoining the first length.

38. A method for creating a line of ablated tissue on a hollow organ or vessel having opposed walls, comprising:

bringing the opposed walls of the organ closer together, but not in contact with one another, along a distance within a plane; and

ablating tissue in the opposing walls along the plane to form a corresponding line of ablated tissue through the opposed walls.

39. A method of treating cardiac arrhythmia comprising:

guiding a body of an injectate delivery device within a patient'"'"'s thoracic cavity to position a distal tissue-contacting portion of the body in surface contact with a tissue surface of cardiac tissue;

detecting the surface contact between the tissue-contacting portion and the tissue surface; and

thereafter, injecting a tissue-ablating agent into the cardiac tissue through the tissue-contacting portion of the body.

57. A method of treating atrial fibrillation comprising:

guiding an elongate, flexible body into proximity with an exterior tissue surface of a predetermined portion of a cardiac tissue;

bringing an elongate tissue-contacting portion of the body into surface contact with the tissue surface, the tissue-contacting portion including a plurality of electrodes;

measuring a level of at least one current conducted by the plurality of electrodes, wherein the level depends on a degree of contact between at least two of the electrodes and the tissue surface; and

thereafter, injecting a tissue-damaging fluid into the cardiac tissue at an elevated pressure through a plurality of outlets in the tissue-contacting portion of the body to define a plurality of jets of the tissue-damaging fluid which pass through an entire thickness of the cardiac tissue, creating a transmural signal-impeding lesion in the cardiac tissue.