Interventional medical systems, assemblies and methods

Patent metadata

Field	Value
Publication number	US-9750931-B2
Application number	US-201514620904-A
Country	US
Kind code	B2
Filing date	Feb 12, 2015
Priority date	Feb 12, 2015
Publication date	Sep 5, 2017
Grant date	Sep 5, 2017

Abstract

A system for delivering an implantable medical device includes a loading assembly and a catheter. The loading assembly includes a deployment member and a sidewall defining a chamber into which the device may be pulled through a distal opening thereof, so that the sidewall holds fingers of the device's fixation member in an extended condition while a temperature in the chamber is lowered. When the chamber is connected to the catheter, advancing the deployment member pushes the device, with fixation fingers in the extended condition, into a delivery lumen of the catheter. With the catheter positioned within a patient, the device can be pushed into a distal portion of the catheter while a relatively cold fluid is infused through the delivery lumen. While holding the deployment member in place, retracting the catheter exposes the device fixation fingers out from the lumen, for engagement with tissue at the implant site.

First claim

We claim:

1. An interventional medical system for delivering an implantable medical device to an implant site, the device including an electronic controller, a hermetically sealed housing containing the controller, an electrode electrically coupled to the controller and mounted in proximity to a distal end of the housing, and a fixation member mounted to the distal end of the housing, the fixation member comprising a plurality of fingers spaced apart from one another around a perimeter of the distal end of the housing, each finger being elastically deformable between a relaxed condition and an extended condition, a free end of each finger extending distally away from the distal end of the device housing, when the finger is in the extended condition, and the system comprising:
a loading assembly including a deployment member and a capsule, the deployment member including an elongate shaft and an enlarged distal-most end coupled thereto, the distal-most end being configured to engage around a proximal end of the implantable medical device housing, the capsule including a sidewall, a seal member, and a connector, the sidewall defining a chamber of a size to contain therein the implantable medical device and the distal-most end of the deployment member engaged therewith, the chamber including a proximal opening formed by the seal member and a distal opening sized for passage therethrough of the device and the distal-most end of the deployment member engaged therewith, the distal-most end being sized to prevent passage thereof through the proximal opening, the seal member being configured for sealing and sliding engagement around the shaft of the deployment member, and the connector being formed around the distal opening of the chamber; and
a delivery catheter including an elongate tube and a handle coupled to a proximal end of the tube, the tube and the handle defining a device delivery lumen that extends from a device entry port formed in the handle to a device exit port that terminates a distal portion of the tube, and the handle including a connector formed around the device entry port, the connector of the handle being configured to mate with the connector of the loading assembly capsule;
wherein the size of the capsule chamber of the loading assembly is such that the sidewall holds the fingers of the device fixation member in the extended condition when the device is contained within the chamber; and
when the connector of the loading assembly capsule is mated with the connector of the delivery catheter handle, the device entry port of the delivery catheter is aligned with the distal opening of the capsule chamber thereby allowing passage of the device, with the fixation fingers in the extended condition, from the chamber and into the device delivery lumen of the delivery catheter.

2. The system of claim 1 , wherein the delivery catheter further includes a deflection wire assembly, the deflection wire assembly including a deflection wire, a deflection band, and a control member, the deflection wire extending along a length of the elongate tube and being contained within a sidewall thereof, the deflection band being mounted around the sidewall of the elongate tube and coupled to a distal end of the deflection wire, and the control member being mounted in the handle and coupled to a proximal end of the deflection wire.

3. The system of claim 2 , wherein the deflection band is radiopaque and the delivery catheter further includes another radiopaque band mounted around the sidewall of the elongate tube in proximity to the device exit port of the device delivery lumen, the bands being spaced apart from one another along the distal portion of the tube to indicate, via fluoroscopic imaging, a location therebetween for positioning the device in the device delivery lumen of the catheter.

4. The system of claim 2 , wherein the control member of the deflection wire assembly comprises a torque wheel configured to rotate around a longitudinal axis of the handle.

5. The system of claim 1 , wherein the handle of the delivery catheter further includes an infusion port in fluid communication with the device delivery lumen.

6. The system of claim 1 , wherein the connector of the handle of the delivery catheter comprises a female thread and the connector of the capsule of the loading assembly comprises a male thread.

7. The system of claim 1 , wherein the deployment member of the loading assembly further includes a tether and a pair of lumens through which the tether extends.

8. An assembly for loading an implantable medical device into a delivery catheter, the device including an electronic controller, a hermetically sealed housing containing the controller, an electrode electrically coupled to the controller and mounted in proximity to a distal end of the housing, and a fixation member mounted to the distal end of the housing, the fixation member comprising a plurality of fingers spaced apart from one another around a perimeter of the distal end of the housing, each finger being elastically deformable between a relaxed condition and an extended condition, a free end of each finger extending distally away from the distal end of the device housing, when the finger is in the extended condition, and the delivery catheter including an elongate tube and a handle coupled to a proximal end of the tube, the tube and the handle defining a device delivery lumen, the device delivery lumen extending from a device entry port within the handle to a device exit port in proximity to a distal end of the tube, and the handle including a connector formed around the device entry port, and the assembly comprising:
a deployment member including an elongate shaft and an enlarged distal-most end coupled thereto, the distal-most end being configured to engage around a proximal end of the implantable medical device housing; and
a capsule including a sidewall, a seal member, and a connector, the sidewall defining a chamber of a size to contain therein the implantable medical device and the distal-most end of the deployment member engaged therewith, the chamber including a proximal opening formed by the seal member and a distal opening sized for passage therethrough of the device and the distal-most end of the deployment member engaged therewith, the distal-most end being sized to prevent passage thereof through the proximal opening, the seal member being configured for sealing and sliding engagement around the shaft of the deployment member, and the connector being formed around the distal opening of the chamber and being configured to mate with the connector of the delivery catheter handle;
wherein the sidewall of the capsule chamber holds the fingers of the device fixation member in the extended condition when the device is contained within the chamber; and
when the connector of the capsule is mated with the delivery catheter handle, the device entry port of the handle is aligned with the distal opening of the capsule chamber thereby allowing passage of the device, with the fixation fingers in the extended condition, from the chamber and into the device delivery lumen of the delivery catheter.

9. The assembly of claim 8 , wherein the connector of the capsule comprises a male thread, and the connector of the handle of the delivery catheter comprises a female thread.

10. The assembly of claim 8 , wherein the deployment member further includes a tether and a pair of lumens through which the tether extends.

Assignees

• Medtronic Inc

Inventors

• Wood Rónán
• Ward Sean
• Keaveney James M

Classifications

• A61N1/362 Primary

  Heart stimulators (heart defibrillators A61N1/39) · CPC title

• A61N1/372

  Arrangements in connection with the implantation of stimulators · CPC title

• A61N1/3756

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

• A61N1/37205

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

• A61B17/3468

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