Methods and devices for tissue grasping and assessment

• US 20070197858A1
• Filed: 09/27/2005
• Published: 08/23/2007
• Est. Priority Date: 09/27/2004
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Komtebedde, Jan, Wen-Chin Fan, Sylvia, Powell, Ferolyn, Goldfarb, Eric, Martin, Brian, Thornton, Troy, Raschdorf, Alfred, Liao, Yen, Madden, John, Sarabia, Jaime
• Granted Patent: US 7,635,329 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• CPC Class Codes: A61B 2017/22089 Gas-bubbles
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/2825 Inserts of different material in jaws
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/2931 with releasable head
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped

Abstract

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Claims

1. A method comprising:

advancing a minimally invasive device having a proximal element and a distal element into a body cavity having a tissue;

grasping the tissue between the proximal element and the distal element; and

assessing the presence of the tissue in a target area between the proximal and distal elements.

2. A method as in claim 1, wherein the tissue comprises valve leaflets.

3. A method as in claim 1, wherein assessing the presence comprises observing the target area under fluoroscopy, ultrasound or echocardiography.

4. A method as in claim 3, further comprising enhancing the visibility of at least a portion of the proximal element and/or the distal element.

5. A method as in claim 3, further comprising enhancing the visibility of the tissue.

6. A method as in claim 1, wherein the device includes an indicator which indicates the presence of tissue within the target area, the method further comprising observing the indicator.

7. A method as in claim 6, wherein the indicator changes shape and/or orientation based on the presence of tissue within the target area, and wherein observing the indicator includes observing the change in shape and/or orientation.

8. A method as in claim 1, wherein the device includes an injectable enhanced visibility substance, and wherein assessing the presence of tissue in the target area comprises observing a flow pattern of the enhanced visibility substance.

9. A method as in claim 8, wherein the substance is contained in a reservoir having ports, and wherein assessing the presence of tissue in the target area comprises observing the substance flowing through ports near the target area.

10. A method as in claim 1, further comprising introducing an injectable enhanced visibility substance through the device, and wherein assessing the presence of tissue in the target area comprises observing the absence of a flow pattern of the enhanced visibility substance.

11. A method as in claim 1, further comprising advancing a probe into the target area, and wherein assessing the presence of the tissue in a target area comprises determining a depth of the probe advancement.

12. A method as in claim 1, wherein the device includes a sensor which indicates the presence of tissue within the target area, the method further comprising evaluating a signal from the sensor.

13. A method comprising:

advancing a minimally invasive device having a proximal element and a distal element into a body cavity having a tissue;

grasping the tissue between the proximal element and the distal element; and

adjusting the tissue between the proximal element and the distal element.

14. A method as in claim 13, wherein adjusting comprises applying suction to the tissue and moving the tissue by suction forces.

15. A method as in claim 13, wherein the device includes a secondary grasper and wherein adjusting comprises grasping and moving the tissue with the secondary grasper.

16. A method as in claim 13, wherein the device includes a rotating component which moves the tissue between the proximal and distal elements, and wherein adjusting comprises rotating the rotating component.

17. A method as in claim 13, wherein the proximal element is moveable relative to the distal element, and wherein adjusting comprises moving the proximal element relative to the distal element.

18. A method as in claim 13, wherein the tissue comprises valve leaflets.

19. A method comprising:

advancing a minimally invasive device into a chamber of a heart having a valve with valve leaflets;

temporarily stabilizing the valve leaflets by reducing movement of the valve leaflets.

20. A method as in claim 19, wherein the chamber comprises the left atrium and the valve comprises the mitral valve, and wherein the device includes a stabilizer, and wherein temporarily stabilizing comprises positioning the stabilizer against the atrial side of the leaflets so as to reduce flail of the leaflets.

21. A method as in claim 20, wherein the stabilizer comprises an expandable member, a flap or at least one loop.

22. A method as in claim 19, wherein the device includes at least one loop, and wherein temporarily stabilizing comprises positioning the at least one loop against the leaflets so as to reduce movement of the leaflets.

23. A method as in claim 22, wherein temporarily stabilizing further comprises moving the at least one loop along the leaflets toward the center of the valve so as to reduce movement of the leaflets.

24. A method as in claim 19, wherein the chamber comprises a ventricle including chordae extending from the ventricle to the valve leaflets, and wherein temporarily stabilizing comprises holding the chordae with the device so as to reduce movement of the valve leaflets.

25. A method as in claim 24, wherein the device includes an expandable member and wherein holding the chordae comprises expanding the expandable member against the chordae.

26. A method as in claim 19, wherein temporarily stabilizing the valve leaflets comprises temporarily slowing the natural pace of the heart with a pacing instrument.

27. A minimally invasive device comprising:

at least one proximal element and at least one distal element configured for grasping tissue therebetween; and

an indicator which indicates a presence or absence of tissue in a target area between the at least one proximal and distal elements.

28. A device as in claim 27, wherein the indicator comprises an enhanced visibility substance.

29. A device as in claim 28, wherein the enhanced visibility substance is disposed on or within the at least one proximal and/or the at least one distal elements.

30. A device as in claim 28, further comprising a reservoir within which the enhanced visibility substance is disposed.

31. A device as in claim 30, wherein the reservoir is configured to release at least a portion of the enhanced visibility substance due to the presence of tissue in the target area between the at least one proximal and distal elements.

32. A device as in claim 30, wherein the reservoir is configured to move locations due to the presence of tissue in the target area between the at least one proximal and distal elements.

33. A device as in claim 28, further comprising a conduit through which the enhanced visibility substance is injectable toward the target area.

34. A device as in claim 27, wherein the indicator is configured to change shape and/or orientation based on a presence of tissue within the target area.

35. A device as in claim 34, wherein the indicator is configured to extend into the target area in the absence of tissue within the target area and to change shape or orientation within the target area due to the presence of tissue within the target area.

36. A device as in claim 34, wherein the indicator comprises a floating block, a flap, a reservoir, a loop, a slackline, a probe, a detectable element, or a combination of any of these.

37. A device as in claim 27, wherein the indicator comprises a sensor.

38. A device as in claim 37, wherein the sensor comprises a conductor, a strain gauge, a radiosensor, an optical sensor, an ultrasound sensor, a magnetic sensor, an infrared sensor, an electrical resistance sensor, an intravascular ultrasound sensor, a pressure sensor or a combination of any of these.

39. A device as in claim 27, wherein the indicator is configured to contact the at least one distal element forming a closed circuit when the tissue is absent within the target area.

40. A minimally invasive device comprising:

at least one proximal element and at least one distal element configured for grasping tissue therebetween; and

an adjustment element configured to adjust a position of the tissue between the at least one proximal and distal elements.

41. A device as in claim 40, wherein the adjustment element comprises a vacuum line configured to apply suction to the tissue to adjust the position of the tissue between the at least one proximal and distal elements.

42. A device as in claim 40, wherein the adjustment element comprises a secondary grasper configured to grasp the tissue to adjust the position of the tissue between the at least one proximal and distal elements.

43. A device as in claim 40, wherein the adjustment element comprises a rotating component configured to move the tissue between the at least one proximal and distal elements.

44. A device as in claim 40, wherein the adjustment element is configured to adjust a position of the at least one proximal element so as to move the tissue in relation to the at least one distal element.

45. A minimally invasive device comprising:

at least one proximal element and at least one distal element configured for grasping tissue therebetween; and

a stabilizer configured to reduce movement of the tissue prior to grasping the tissue between the at least one proximal and distal elements.

46. A device as in claim 45, wherein the tissue comprises a leaflet of a mitral valve, and wherein the stabilizer comprises an expandable member, a flap, an overtube or at least one loop configured to be positioned against an atrial side of the leaflets so as to reduce flail of the leaflets.

47. A device as in claim 46, wherein the stabilizer comprises at least one loop which is moveable toward a center of the valve so as to reduce movement of the leaflet.

48. A device as in claim 45, wherein the tissue comprises a leaflet having chordae extending therefrom, and wherein the stabilizer comprises an expandable member configured to hold the chordae upon expansion so as to reduce movement of the leaflet.

49. A system for assessing quality of fixation of a tissue within a body comprising:

a fixation device having at least one proximal element and at least one distal element configured for grasping tissue therebetween;

a catheter having a proximal end, a distal end and a lumen therethrough, the catheter configured for endoluminal advancement through at least a portion of the body to the tissue; and

a shaft removably coupled to the fixation device, wherein the shaft is configured to pass through the lumen of the catheter, wherein at least a portion of the shaft is flexible to allow movement of the fixation device relative to the catheter while the tissue is grasped between the at least one proximal element and the at least one distal element.

50. A system as in claim 49, wherein the shaft comprises a compression coil.

51. A system as in claim 50, further comprising a center actuation wire configured to extend through the coil so as to rigidify the coil.

52. A system as in claim 49, further comprising a sheath extendable over the at least a portion of the flexible shaft so as to rigidify the shaft.

53. A method of fixing a pair of valve leaflets together along their coaptation line, the method comprising:

fixing the pair of valve leaflets together at a first location along the coaptation line with a first fixation device; and

fixing the pair of valve leaflets together at a second location along the coaptation line with a second fixation device, wherein the first and second locations differ.

54. A method as in claim 53, wherein the first and second locations are adjacent to each other.

55. A method as in claim 53, wherein the first and second locations are approximately 1 cm apart.

56. A method as in claim 53, wherein the first and second locations are positioned so as to provide a double orifice geometry when a pressure gradient opens the pair of valve leaflets.

57. A method as in claim 53, wherein the first and second locations are positioned so as to provide a triple orifice geometry when a pressure gradient opens the pair of valve leaflets.

58. A method as in claim 53, wherein the first fixation device has a first pair of grasping elements and a second pair of grasping elements, and wherein fixing the pair of valve leaflets together at the first location comprises grasping one leaflet of the pair of valve leaflets between the first pair of grasping elements and grasping another leaflet of the pair of valve leaflets between the second pair of grasping elements.

59. A method as in claim 58, wherein the second fixation device has a first pair of grasping elements and a second pair of grasping elements, and wherein fixing the pair of valve leaflets together at the second location comprises grasping one leaflet of the pair of valve leaflets between the first pair of grasping elements of the second fixation device and grasping another leaflet of the pair of valve leaflets between the second pair of grasping elements of the second fixation device.

60. A method as in claim 53, further comprising assessing performance of the valve leaflets after the step of fixing the pair of valve leaflets together at the first location to determine need for the step of fixing the pair of valve leaflets together at the second location.