Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly

• US 20060149123A1
• Filed: 03/07/2006
• Published: 07/06/2006
• Est. Priority Date: 03/21/2000
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., LaPlante, Jeffrey P., Mortier, Todd J., Schweich, Cyril J. Jr., Kusz, David A., Paulson, Thomas M., Schroeder, Richard F.
• Application Number:
  US11/368,445
• Publication Number:
  US 20060149123A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A splint assembly for placement transverse a heart chamber to reduce the heart chamber radius and improve cardiac function has a tension member formed of a braided cable with a covering. A fixed anchor assembly is attached to one end of the tension member and a leader for penetrating a heart wall and guiding the tension member through the heart is attached to the other end. An adjustable anchor assembly can be secured onto the tension member opposite to the side on which the fixed pad assembly is attached. The adjustable anchor assembly can be positioned along the tension member so as to adjust the length of the tension member extending between the fixed and adjustable anchor assemblies. The pad assemblies engage with the outside of the heart wall to hold the tension member in place transverse the heart chamber. A probe and marker delivery device is used to identify locations on the heart wall to place the splint assembly such that it will not interfere with internal heart structures. The device delivers a marker to these locations on the heart wall for both visual and tactile identification during implantation of the splint assembly in the heart.

Claims

1-41. -41. (canceled)

42. An apparatus for improving cardiac function, comprising:

an elongate member attached to a leader member at one end thereof and being configured to extend transverse a heart chamber;

a first heart-engaging assembly attached to the other end of the elongate member and configured to engage a first exterior location of a heart wall; and

a second heart-engaging assembly configured to slidably receive the leader member and the elongate member to thereby secure to the elongate member and to engage a second exterior location of the heart wall, wherein the second heart-engaging assembly is configured to be slidably positioned along the elongate member prior to securement to the elongate member such that a length of the elongate member between the first and second heart-engaging assemblies can be adjusted during placement of the elongate member transverse the heart chamber.

43. The apparatus of claim 42, wherein the leader member includes a hollow tube.

44. The apparatus of claim 43, wherein a mandrel extends through a portion of the leader tube and into the elongate member to secure the leader tube and the elongate member to each other.

45. The apparatus of claim 42, wherein the leader member is configured to be severed from the elongate member after the second heart-engaging assembly has been secured to the elongate member.

46. An apparatus for determining and marking a location on a heart wall, comprising:

a marker delivery mechanism configured to hold a marker; and

an actuator operatively connected to the marker delivery mechanism for delivering a marker to the location,

wherein a distal end of the delivery mechanism is configured to be visible relative to internal heart structures.

47. The apparatus of claim 46, wherein the apparatus includes the marker and wherein the marker includes a tip configured to penetrate into the heart wall.

48. The apparatus of claim 47, wherein the marker includes a suture line extending from the tip.

49. The apparatus of claim 47, wherein the marker includes gripping prongs protruding from the tip.

50. The apparatus of claim 47, wherein the marker tip is made of polyetheretherketone.

51. The apparatus of claim 46, wherein the distal end is configured to create relatively localized indentations in the heart wall.

52. The apparatus of claim 51, wherein the distal end has an essentially frustro-conical configuration.

53. The apparatus of claim 46, wherein the marker delivery mechanism includes a shaft configured to removably receive a tube housing the marker.

54. The apparatus of claim 53, wherein the actuator moves the tube relative to the shaft to move the marker through the distal end and into the heart wall.

55. The apparatus of claim 46, wherein the actuator includes an advancing button configured to move the marker through the distal end and into the heart wall.

56. A method for placing a splint assembly transverse a heart chamber, comprising:

providing an elongate member with a leader member attached to a first end and a first heart-engaging assembly attached to a second end;

guiding the leader member through a first exterior location on a heart wall;

guiding the leader member through a second exterior location on the heart wall to thereby extend the elongate member transverse the heart chamber; and

adjusting the length of the elongate member extending through the heart chamber by securing a second heart-engaging assembly to the elongate member at a position along the length of the elongate member exterior the chamber at the second location.

57. The method of claim 56, wherein securing the second heart-engaging assembly includes penetrating the elongate member with a fixation member.

58. The method of claim 57, wherein the fixation member includes a staple and penetrating the elongate member is performed by advancing the staple from a first position to a second position.

59. The method of claim 56, wherein the first and second exterior locations on the heart wall are identified by indenting portions of the heart wall and viewing the indentations relative to internal structures in the heart.

60. The method of claim 59, further including marking the predetermined locations with a marker that penetrates the heart wall.

61. The method of claim 56, wherein the indenting and marking steps are performed using an apparatus comprising:

a marker delivery mechanism configured to hold a marker; and

an actuator operatively connected to the marker delivery mechanism for delivering a marker to the location,

wherein a distal end of the delivery mechanism is configured to be visible relative to internal heart structures.

62. A tool for fixing an elongate member to a housing, comprising:

an engagement member configured to engage a fixation member to be advanced within the housing;

a wire having a first end secured to the engagement member, the wire being configured to pass through the housing; and

a handle connected to a second end of the wire,

wherein the engagement member and the wire are configured to move through the housing to advance the fixation member within the housing and into engagement with the elongate member when the handle is actuated.

63. The device of claim 62, wherein the fixation member includes a staple and the housing is a disk-shaped pad.

64. The device of claim 62, wherein the engagement member and wire are configured to move through a channel defined within the housing.

65. The device of claim 62, wherein the handle rotates during actuation.

66. The device of claim 62, wherein the engagement member and wire are configured to be removed from the housing after advancing the fixation member within the housing.