ANNULOPLASTY DEVICES AND METHODS OF DELIVER THEREFOR

• US 20110166649A1
• Filed: 06/15/2009
• Published: 07/07/2011
• Est. Priority Date: 06/16/2008
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Cabiri, Oz, Miller, Eran, Gross, Amir, Mosaiuf, Arnon, Grossfeld, Ram, Lilach, Nir, Eliachar, Eliahu, Meyer-Brodnitz, Gideon, Golom, Dmitry, Beinart, Iftah
• Granted Patent: US 9,192,472 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Apparatus is provided, including a tube (421) shaped to define a tube lumen at least one implant (100) reversibly coupled to the tube (421), and configured for implantation within a body of a patient. The apparatus also comprises two or more longitudinal guide members (470) disposed at least in part along a distal portion of the tube (421), the longitudinal guide members (470) having distal portions thereof configured to be reversibly coupled to the implant (100), and arranged such that application of a force to a first one of the longitudinal guide members (470) steers the distal portion of the tube (421) toward a first location along the implant (100), and application of a force to a second one of the longitudinal guide members (470) steers the distal portion of the tube (421) toward a second location along the implant (100). Other embodiments are also described.

Claims

1. Apparatus, comprising:

a tube shaped to define a tube lumen;

at least one implant reversibly coupled to the tube, and configured for implantation within a body of a patient; and

two or more longitudinal guide members disposed at least in part along a distal portion of the tube, the longitudinal guide members having distal portions thereof configured to be reversibly coupled to the implant, and arranged such that application of a force to a first one of the longitudinal guide members steers the distal portion of the tube toward a first location along the implant, and application of a force to a second one of the longitudinal guide members steers the distal portion of the tube toward a second location along the implant.

3. The apparatus according to claim 1, wherein the apparatus further comprises a housing configured to surround at least a portion of the tube, the housing being shaped to define one or more channels configured for passage therethrough of the two or more longitudinal guide members, and wherein the housing is configured to move rotationally with respect to a longitudinal axis of the tube.

4. The apparatus according to claim 1, wherein the implant comprises a contracting mechanism comprising a flexible contracting member having a first portion and an end portion that is configured to advance with respect to the first portion to contract the implant.

5. The apparatus according to claim 4, wherein:

the implant is shaped to define at least one tubular body portion having at least one implant lumen therein,

the contracting member comprises a wire disposed at least in part within the implant lumen, and

the implant is configured to be advanced toward a left atrium of the patient in a generally straight configuration and subsequently to assume a curved configuration in response to a contracting force applied thereto by contraction of the wire.

10. The apparatus according to claim 1, further comprising at least one anchor configured to be advanced through the lumen of the tube, wherein the anchor is configured to be advanced through a portion of the implant at the first location in response to steering the distal portion of the tube toward the first location by applying the force to the first one of the longitudinal guide members, and wherein the first one of the longitudinal guide members is configured to be decoupled from the implant subsequent to the anchoring of the anchor to tissue of the patient.

36. The apparatus according to claim 1, wherein the two or more longitudinal guide members are reversibly coupled to the distal portion of the tube.

37. The apparatus according to claim 1, further comprising a plurality of anchors, wherein the plurality of anchors are disposed within the tube lumen.

38. The apparatus according to claim 1, wherein:

the apparatus further comprises at least first and second tissue anchors,

the first anchor is configured to anchor the implant to tissue at the first location along the implant,

the second anchor is configured to anchor the implant to tissue at the second location along the implant,

the tube comprises a single tube having at least one tube lumen, and

the first and second anchors are advanceable through the tube lumen of the single tube.

39. The apparatus according to claim 1, wherein:

the first location along the implant comprises a first pre-designated location along the implant for passage of a first anchor therethrough,

the first longitudinal member is coupled to the first pre-designated location along the implant,

the second location along the implant comprises a second pre-designated location along the implant for passage of a second anchor therethrough, and

the second longitudinal member is coupled to the second pre-designated location.

40. The apparatus according to claim 1, wherein the implant includes a structure that is configured to be positioned on a native annulus of a native atrioventricular valve of the patient and to facilitate treatment of the native valve.

41. The apparatus according to claim 40, wherein the implant comprises an adjustable annuloplasty structure.

42. The apparatus according to claim 1, further comprising a delivery tool having a delivery tool lumen, wherein the tube and the implant are configured to be disposed within the delivery tool lumen and to be advanceable within the delivery tool lumen and toward an implantation site during a single advancement of the delivery tool.

43. The apparatus according to claim 42, wherein the implant is disposed distally to the tube when the implant and the tube are disposed within the delivery tool lumen.

44. The apparatus according to claim 3, wherein the housing is shaped to define two or more channels, wherein each channel is configured for passage therethrough of a respective one of the two or more longitudinal guide members.

45. The apparatus according to claim 4, wherein the contracting mechanism comprises a ratchet mechanism configured to adjust a dimension of the implant responsively to actuation of the flexible contracting member.

2. (canceled)

6-9. -9. (canceled)

11. (canceled)

12. A method for facilitating treatment of a native atrioventricular valve of a body of a patient, the valve including an annulus and at least first and second leaflets, comprising:

advancing a tube shaped to define a tube lumen toward the valve of the patient;

advancing toward the valve at least one implant reversibly coupled to the tube and at respective locations thereof to two or more longitudinal guide members at respective distal portions thereof, the longitudinal guide members being disposed at least in part along a distal portion of the tube;

positioning the implant against the annulus of the patient;

steering the distal portion of the tube toward a first location along the implant by pulling a first one of the two or more longitudinal guide members; and

steering the distal portion of the tube toward a second location along the implant by pulling a second one of the two or more longitudinal guide members.

13. The method according to claim 12, wherein advancing the tube and the implant comprises transcatheterally advancing the tube and the implant during a single transcatheter advancement thereof.

14. The method according to claim 12, further comprising:

advancing a first anchor through the lumen of the tube subsequently to steering the tube toward the first location,

anchoring the implant at the first location thereof to the annulus by advancing the first anchor through the implant and into tissue of the annulus,

advancing a second anchor through the lumen of the tube subsequently to steering the tube toward the second location, and

anchoring the implant to the annulus at the second location thereof by advancing the second anchor through the implant and into tissue of the annulus.

46. The method according to claim 12, further comprising, prior to the advancing the tube and the advancing the implant, placing the tube and the implant within a lumen of a delivery tool, and wherein advancing the tube and advancing the implant comprises advancing the tube and the implant during a single advancement of the delivery tool.

47. The method according to claim 46, wherein advancing the tube and the implant comprises placing the tube and the implant within the delivery tool lumen in a manner in which the implant is disposed distally to the tube, and wherein advancing the tube and the implant comprises advancing the implant distally to the tube.

15-35. -35. (canceled)