Delivery system for implanting a medical device

Patent metadata

Field	Value
Publication number	US-12186519-B2
Application number	US-201917271464-A
Country	US
Kind code	B2
Filing date	Aug 13, 2019
Priority date	Aug 27, 2018
Publication date	Jan 7, 2025
Grant date	Jan 7, 2025

Abstract

A delivery system for implanting a medical device comprises a delivery catheter having an inner lumen, a mandrel received in the inner lumen of the delivery catheter and movable with respect to the delivery catheter, and an adapter piece connected to the mandrel, wherein the adapter piece, by moving the mandrel with respect to the delivery catheter, is displaceable between a first position in which the adapter piece is received within the inner lumen of the delivery catheter and a second position in which the adapter piece is arranged outside of the inner lumen of the delivery catheter. A tethering member comprises a positive-locking member adjoining a tether portion, wherein the positive-locking member in a connection state is received on the adapter piece, but is releasable from the adapter piece by displacing the adapter piece from the first position towards the second position.

First claim

The invention claimed is:

1. A delivery system for implanting a medical device, comprising:
a leadless pacemaker device for providing a pacing of the heart's activity;
a delivery catheter having an inner lumen,
a mandrel received in the inner lumen of the delivery catheter and movable with respect to the delivery catheter,
an adapter piece connected to the mandrel, wherein the adapter piece, by moving the mandrel with respect to the delivery catheter, is displaceable between a first position in which the adapter piece is received within the inner lumen of the delivery catheter and a second position in which the adapter piece is arranged outside of the inner lumen of the delivery catheter, and
a tethering member comprising a tether portion having a first end at which the tethering member is connected to the adapter piece, the tether portion also having a second end spaced from the first end, wherein the tethering member further comprises a positive-locking member adjoining the tether portion at a distance from the first end,
wherein the positive-locking member in a connection state is received on the adapter piece and is locked with respect to the adapter piece while the adapter piece is in the first position, and
wherein the positive-locking member is releasable from the adapter piece by displacing the adapter piece from the first position towards the second position, and
wherein when the positive-locking member is in the connection state, the tether portion in between the first end and the second end hence forms a loop such that by means of the tether portion a fixed connection of the leadless pacemaker to the delivery system is established.

2. The delivery system of claim 1 , wherein the positive-locking member comprises a first diameter, measured along a plane perpendicular to a longitudinal axis of extension of the tethering member, larger than a second diameter of the tether portion.

3. The delivery system of claim 1 , wherein the positive-locking member has a spherical shape.

4. The delivery system of claim 1 , wherein the adapter piece comprises a body and a retainer groove formed on the body, wherein the tether portion in the connection state is received in the retainer groove.

5. The delivery system of claim 4 , wherein the adapter piece comprises a recess formed on the body and adjoining the retainer groove, wherein the positive-locking member in the connection state is received in the recess.

6. The delivery system of claim 5 , wherein the adapter piece is movable along a longitudinal direction between the first position and the second position with respect to the catheter device, wherein the recess is open at a lateral side of the adapter piece such that the positive-locking member is enabled to disengage from the recess in a direction transverse to the longitudinal direction if the adapter piece is in the second position, but is blocked from disengaging from the recess by the delivery catheter if the adapter piece is in the first position.

7. The delivery system of claim 5 , wherein the adapter piece comprises a slanted face formed on the body at a transition between the recess and the retainer groove, wherein the slanted face is formed such that the positive-locking member is guided to release the tether portion from the retainer groove in case the locking of the positive-locking member with respect to the adapter piece is released and a pulling force (F) is exerted on the tether portion.

8. The delivery system of claim 5 , further comprising a security device which is operatively connected to the mandrel, the security device being configured to prevent, in a first actuation state, a movement of the mandrel for releasing the positive-locking member from the adapter piece.

9. The delivery system of claim 8 , wherein the security device comprises an actuation member which is actuatable for transferring the security device from the first actuation state to a second actuation state, the security device being configured to allow, in the second actuation state, a movement of the mandrel for releasing the positive-locking member from the adapter piece.

10. The delivery system of claim 8 , wherein the security device comprises a housing body and a blocking opening formed therein through which the mandrel is passed, wherein the security device in the first actuation state blocks a movement of a portion of the mandrel through the blocking opening and in the second actuation state allows a movement of said portion of the mandrel through the blocking opening.

11. An assembly comprising a delivery system of claim 1 and a medical device having a housing and a connection member arranged on the housing, wherein the tether portion of the tethering member in the connection state is connected to the connection member.

12. The assembly of claim 11 , wherein the connection member comprises an opening through which the tether portion extends in the connection state.

13. The assembly of claim 12 , wherein the connection member comprises a shaft bordering the opening, wherein the tether portion in the connection state extends about the shaft.

14. The assembly of claim 13 , wherein the connection member comprises a rounded face having, when viewed in a plane perpendicular to a longitudinal axis (L) of the shaft, a convex curvature, the rounded face bordering the opening at a side opposite the shaft.

15. A method for releasing a medical device from a delivery system, comprising:
providing the delivery system in a state in which the medical device is connected to the delivery system, the medical device comprising a leadless pacemaker device for providing a pacing of the heart's activity, the delivery system comprising a delivery catheter having an inner lumen, a mandrel received in the inner lumen of the delivery catheter and an adapter piece connected to the mandrel, wherein the adapter piece, by moving the mandrel with respect to the delivery catheter, is displaceable between a first position in which the adapter piece is received within the inner lumen of the delivery catheter and a second position in which the adapter piece is arranged outside of the inner lumen of the delivery catheter, wherein the delivery system further comprises a tethering member comprising a tether portion having a first end at which the tethering member is connected to the adapter piece, the tether portion also having a second end spaced from the first end, and the tethering member further comprises a positive-locking member adjoining the tether portion at a distance from the first end, wherein the positive-locking member in a connection state is received on the adapter piece and is locked with respect to the adapter piece while the adapter piece is in the first position, wherein the tether portion of the tethering member in the connection state is connected to a connection member of the medical device, wherein when the positive-locking member is in the connection state, the tether portion in between the first end and the second end hence forms a loop such that by means of the tether portion a fixed connection of the leadless pacemaker to the delivery system is established, and
releasing the positive-locking member from the adapter piece by displacing the adapter piece from the first position towards the second position by moving the mandrel for disconnecting the connection member of the medical device from the tether portion.

Assignees

• Biotronik Se & Co Kg

Inventors

• Devich Nicholas
• Austin Eric
• Taff Brian M

Classifications

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61N1/3756

  Casings with electrodes thereon, e.g. leadless stimulators · CPC title

• A61N1/37205 Primary

  Microstimulators, e.g. implantable through a cannula · CPC title

• A61M2039/1077

  Adapters, e.g. couplings adapting a connector to one or several other connectors · CPC title

• A61M25/0082

  Catheter tip comprising a tool · CPC title