HANDLE FOR MANIPULATING A CATHETER TIP, CATHETER SYSTEM AND MEDICAL INSERTION SYSTEM FOR INSERTING A SELF-EXPANDABLE HEART VALVE STENT

• US 20110015616A1
• Filed: 05/12/2008
• Published: 01/20/2011
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Jung, Johannes, Straubinger, Helmut
• Granted Patent: US 9,295,551 B2
• Time in Patent Office: Days
• US Class Current: 604/528
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter insertion system for inserting an expandable valve stent into the body of a patient and a method of implanting a valve stent. The catheter insertion system includes a catheter having a handle for manipulating a catheter tip, and enables the implantation of a valve prosthesis attached to a valve stent. The handle is configured to enable a pre-set sequence of steps to manipulate the catheter tip and sequentially release the valve stent. The catheter tip is configured to sequentially release the valve stent from a first collapsed mode to a second expanded mode.

Claims

1-43. -43. (canceled)

44. A method of implanting an endoprosthesis including a plurality of positioning arches and a plurality of retaining arches, the method comprising:

positioning the endoprosthesis relative to a native heart valve;

manipulating a first operating mechanism of a catheter to affect movement of a first sleeve element in a first direction toward a handle of the catheter to uncover the plurality of positioning arches; and

positioning the positioning arches within pockets of the native heart valve; and

manipulating a second operating mechanism of the catheter to affect movement of a second sleeve element in a second direction away from the handle of the catheter to uncover the plurality of retaining arches.

45. The method of claim 44, further including releasing a temporary securing mechanism before the step of manipulating the second operating mechanism.

46. The method of claim 44, wherein the first operating mechanism is a wheel rotatably mounted adjacent the handle of the catheter such that relative rotation of the wheel is transferred into longitudinal movement of the first sleeve portion.

47. The method of claim 46, further including selectively rotating the wheel between a first stop and a second stop to thereby define a stroke length for the longitudinal movement of the first sleeve portion.

48. The method of claim 44, wherein the second operating mechanism is a slide mechanism.

49. The method of claim 48, further including selectively longitudinally displacing the slide mechanism between a first stop and a second stop to thereby define a stroke length for the longitudinal movement of the second sleeve portion.

50. The method of claim 44, further including:

further manipulating the first operating mechanism to affect further movement of the first sleeve in the first direction to uncover a plurality of retaining elements of the endoprosthesis.

51. The method of claim 50, further including releasing a temporary securing mechanism before the step of further manipulating the first operating mechanism.

52. The method of claim 44, further including manipulating a third operating mechanism to affect rotation of the second sleeve portion about the longitudinal axis of the catheter.

53. The method of claim 44, wherein the catheter includes a tip region that includes the first and second sleeve portions and a handle region that includes the first and second operating mechanisms, the method further including manipulating a fourth operating mechanism to affect deflection of the tip region relative to the handle region.

54. The method of claim 44, further including:

manipulating the second operating mechanism to affect movement of the second sleeve element in the first direction to cover the plurality of retaining arches; and

subsequently manipulating the first operating mechanism to affect movement of the first sleeve element in the second direction to cover the plurality of positioning arches.

55. A catheter for implanting an endoprosthesis having a plurality of positioning arches and a plurality or retaining arches, comprising

a retaining portion configured to selectively fix the endoprosthesis to the catheter;

a first housing portion disposed adjacent a tip portion of the catheter and configured to selectively retain the plurality of positioning arches in a collapsed state;

a second housing portion disposed adjacent the tip portion of the catheter configured to selectively retain the plurality of retaining arches in a collapsed state;

a first manipulating mechanism configured to cooperate with and selectively manipulate the first housing portion to move longitudinally with respect to the retaining portion and toward a handle portion of the catheter; and

a second manipulating mechanism configured to cooperate with and selectively manipulate the second housing portion to move longitudinally with respect to the retaining portion and away from the handle portion of the catheter.

56. The catheter of claim 55, further including a turning mechanism configured to affect deflection of the tip portion of the catheter relative to the handle portion of the catheter.

57. The catheter of claim 55, further including a stop mechanism configured to selectively prohibit the second manipulating mechanism from manipulating the second housing portion.

58. The catheter of claim 55, wherein the first manipulating mechanism is a wheel mechanism configured to be rotated by a user to affect longitudinal movement of the first housing portion.

59. The catheter of claim 55, wherein the first manipulating mechanism is a trigger mechanism configured to be translated by a user to affect longitudinal movement of the first housing portion.

60. The catheter of claim 55, wherein the first manipulating mechanism is a slide mechanism configured to be translated by a user to affect longitudinal movement of the first housing portion.

61. The catheter of claim 55, further including a turning mechanism configured to affect rotation of the second housing portion about a longitudinal axis of the catheter.

62. The catheter of claim 55, wherein the catheter is configured to position the plurality of positioning arches between the first and second housing portions.

63. A catheter for implanting an endoprosthesis having a first portion and a second portion, comprising:

a retaining portion configured to selectively fix the endoprosthesis to the catheter;

a first housing portion disposed adjacent a tip portion of the catheter and configured to selectively retain the first portion of the endoprosthesis in a collapsed state;

a second housing portion disposed adjacent the tip portion of the catheter configured to selectively retain the second portion of the endoprosthesis in a collapsed state;

a first guide mechanism disposed adjacent a handle portion of the catheter that is longitudinally opposite the tip portion of the catheter, the first guide mechanism including a plurality of first catches; and

a first manipulating portion configured to cooperate with and selectively manipulate the first housing portion to move longitudinally with respect to the retaining portion, the first manipulating portion including at least one engaging mechanism shaped to be complimentary to each of the plurality of first catches;

wherein the first manipulating portion includes a first, fixed mode when the at least one engaging mechanism selectively engages one of the plurality of first catches prohibiting the first housing portion from moving longitudinally, and a second, movable mode when the at least one engaging mechanism selectively disengages the plurality of first catches permitting the first housing portion to move longitudinally.

64. The catheter of claim 63, wherein the first manipulating portion further includes at least one spring element configured to bias the at least one engaging mechanism toward engagement with one of the plurality of first catches.

65. The catheter of claim 63, wherein the plurality of first catches includes at least four first catches arranged in two pairs such that each of the two pairs is configured to define a different longitudinal stroke length for the first housing portion.

66. The catheter of claim 63, further including:

a second guide mechanism disposed adjacent the handle portion of the catheter and including a plurality of second catches; and

a second manipulating portion configured to cooperate with and selectively manipulate the second housing portion to move in a longitudinal direction with respect to the retaining portion and including at least one engaging mechanism shaped to be complimentary to each of the plurality of second catches;

wherein the second manipulating portion includes a first, fixed mode when the at least one engaging mechanism selectively engages one of the plurality of second catches prohibiting the second housing portion from moving longitudinally, and a second, movable mode when the at least one engaging mechanism selectively disengages the plurality of second catches permitting the second housing portion to move longitudinally.

67. The catheter of claim 66, wherein the second manipulating portion includes a pusher knob configured to be gripped by a user.

68. The catheter of claim 66, further including first and second force transmission members configured to transmit longitudinal movement of the first and second manipulating portions respectively to the first and second housing portions.

69. The catheter of claim 68, wherein the first and second force transmission members are coaxial.

70. The catheter of claim 66, wherein the second manipulating portion further includes at least one spring element configured to bias the at least one engaging mechanism of the second manipulating portion toward engagement with the plurality of second catches.

71. The catheter of claim 63, wherein the first manipulating portion is a pusher knob configured to be gripped by a user.