JPWO2020109596A5

JPWO2020109596A5 -

Info

Publication number: JPWO2020109596A5
Application number: JP2021531313A
Authority: JP
Publication date: 2022-12-07

Claims

A catheter device for repairing the heart by implanting an artificial cord, comprising:
a leaflet anchor for placement on a leaflet of a heart valve, the leaflet anchor configured to be coupled to a cord wire;
A leaflet anchor deployment mechanism for deploying the leaflet anchor to attach the leaflet anchor to the leaflet of the heart, the leaflet anchor deploying mechanism comprising a mechanical grasping device for grasping the leaflet of the heart valve. wherein the grasping device comprises a leaflet anchor deployment mechanism including a leaflet anchor tube for housing the leaflet anchor in a collapsed configuration;
The grasping device and the leaflet anchor are configured such that, in use, the grasping device grasps the leaflet and the leaflet anchor is pushed out of the leaflet anchor tube to penetrate the leaflet and secure the leaflet anchor. configured such that it can be formed in an unfolded configuration whereby the hook-shaped formation of the leaflet anchor can secure the leaflet anchor to the leaflet during use;
The mechanical gripping device is a first gripping arm pivotally coupled to the body of the catheter device, the first gripping arm moving away from the body of the catheter device. a first grasping arm coupled to said body so as to be rotatable relative to said catheter device so as to move an outer end of said arm; a second grasping arm slidably coupled to the catheter device such that the second grasping arm moves an outer end of the second grasping arm away from the body of the catheter device; a second gripping arm coupled to said body so as to be pivotable and/or slidable relative to said body;
the first and second grasping arms are configured to be movable to contact each other at a point remote from the body of the catheter device;
catheter device.

the leaflet anchor tube is housed within the first grasping arm;
A catheter device according to claim 1 .

the leaflet anchor is configured to be deployed by pushing from an opening in the end of the leaflet anchor tube at the end of the first grasping arm;
A catheter device according to claim 2.

A catheter device according to claim 1, 2 or 3, wherein
The second grasping arm is a leaflet motion restrictor, the leaflet motion restrictor is configured to be retracted within an interior space of the body of the catheter device, the leaflet motion restrictor includes a wire. including
The wire is made of an elastic material, so that the wire can be stored in the internal space in an elastically deformed state, the outer end of the leaflet motion restrictor being connected to the catheter device. returns to a non-deformed state when moved away from the body of the
Optionally, said non-deformed shape of said leaflet motion restrictor comprises a plurality of bends and/or curvatures parallel to said leaflet surface.
catheter device.

The non-deformed shape of the leaflet motion restrictor includes a whorl toward an end of the leaflet motion restrictor, the end of the leaflet motion restrictor located toward the center of the whorl. ,
A catheter device according to claim 4 .

A catheter device according to claim 4 or 5,
The end portion of the valve cusp motion suppressor includes a wire stopper, and the wire stopper is wider than the inner space.
or
wherein the leaflet motion restrictor is a looped wire, the loop of wire preventing the leaflet motion restrictor from being fully retracted into the interior space;
catheter device.

The second gripping arm is a molded body cut from a metal sheet placed in the body of the catheter device in an elastically deformed state, such that the second gripping arm extends into the body. allowing a smaller profile to be assumed for insertion of the second grasping arm, thereby expanding the second grasping arm to a non-deformed state as it enters the body.
4. A catheter device according to claim 1, 2 or 3.

a hinge mechanism for the second gripping arm is formed in the device by using two holes, in which a pin is formed in the second gripping arm that fits in the holes;
8. A catheter device according to claim 1, 2, 3 or 7 .

The first gripping arm is configured such that the first gripping arm is positioned against the body of the catheter device before the second gripping arm is free to pivot and/or slide within the full range of motion of the second gripping arm. act to surround the second gripping arm so that it needs to be pivoted a certain amount away from the
A catheter device according to claim 7 or 8 .

A catheter device according to claim 1, 2, 3, 7, 8 or 9, wherein
the catheter device includes a hinge mechanism for the first grasping arm, the hinge mechanism integrally formed with material of the body and pivoted away from the body by elastic deformation of the material;
Optionally, a single wire elastically deforms the first gripping arm by bending the hinge mechanism to pivot the end of the first gripping arm away from the body. wherein in this state the first gripping arm resiliently returns to the rest position of the first gripping arm when no force is applied to the wire.
catheter device.

A catheter device according to claim 10, wherein
the body of the catheter includes an outer tube, wherein the hinge mechanism and/or the first gripping arm are formed as articulated sections of the outer tube;
and/or
slits and/or patterns are provided in the outer tube to allow bending of the material of the outer tube without plastic deformation and to provide weakened portions forming the hinge mechanism;
catheter device.

wherein the body of the catheter device is formed from a resilient metal;
A catheter device according to any one of claims 1, 2 , 3 and 7-11 .

In a catheter device according to any one of claims 1-12,
The catheter device comprises
A two-part housing section extending along the length of the catheter device from the distal end of the catheter device toward the proximal end of the catheter device, wherein during use of the catheter device, the papillary muscles of the heart and the papillary muscles of the heart; a two-section comprising a distal section at the distal end of the catheter device and a proximal section located proximal to the distal section configured to be positioned between a valve leaflet; a formula housing section;
the leaflet anchor deployment mechanism in the proximal portion of the housing section;
a papillary anchor deployment mechanism at the distal portion of the housing section for deploying a papillary anchor for attachment to the papillary muscle, the papillary anchor deploying mechanism distally outwardly relative to the distal portion; a nipple anchor deployment mechanism configured to deploy the nipple anchor by moving the nipple anchor;
A flexible joint located between the proximal portion and the distal portion of the two-part housing section, wherein the centerline of the distal portion is angled with respect to the centerline of the proximal portion. with flexible joints that allow
Optionally, said flexible joint is made of a composite material, said composite material covering the entire catheter device, such that said tube also forms said distal and said proximal portions of said two-part housing section. It also acts as a structural component,
Further optionally, said first gripping arm is provided on said proximal portion of said two-part housing section and is pivotally coupled to said catheter device.
catheter device.

A catheter device according to any one of claims 1 to 13,
The leaflet anchor deployment mechanism comprises a first configuration and a second configuration and includes a grasping device for retracting and repositioning the leaflet anchor after deployment of the leaflet anchor into the leaflet. wherein the first configuration is configured to allow deployment of the leaflet anchor into the leaflet without disengaging the leaflet anchor from the ejector unit. the second configuration is a configuration in which the leaflet anchor is reversibly released from the ejector unit; and in the first configuration, the grasping device of the ejector unit is configured to grasping the proximal end of the anchor and the distal end of the leaflet anchor unobstructed by the grasping device to allow the leaflet anchor to be implanted in the leaflet; , the grasping device of the ejector unit is disengaged from the leaflet anchor;
and/or
the leaflet anchor can be pushed out of the leaflet anchor deployment mechanism in a direction extending from the distal end of the catheter device toward the proximal end of the catheter device;
and/or
the catheter device comprises a U-shaped rod for deployment of the leaflet anchor;
catheter device.

A method for manufacturing a catheter device according to any one of claims 1 to 14 ,
The method includes forming a hinge mechanism for the first grasping arm integrally with the body of the catheter device via cutting a resilient metal tube;
The method optionally includes forming the entirety of the first grasping arm, including the hinge mechanism, integrally with the body of the catheter device.