Interventional medical systems and implantable medical devices including tethering features, and associated methods

Patent metadata

Field	Value
Publication number	US-2016325104-A1
Application number	US-201514706662-A
Country	US
Kind code	A1
Filing date	May 7, 2015
Priority date	May 7, 2015
Publication date	Nov 10, 2016
Grant date	—

Abstract

A tethering feature includes an elongate break-away member and a base, and forms a proximal end of an implantable medical device housing. A tether attachment zone of the break-away member extends between break-away member ends, and the base includes a pair of supports, wherein each end of the break-away member is wrapped around a corresponding support. A delivery catheter tether may be attached to the device tethering feature by passing a looped portion of the tether around the tether attachment zone. The device may be untethered from the catheter by applying a pull force through the attached tether, while a distal end of a shaft of the catheter, which abuts the device proximal end, provides a back-up force, the pull force unwrapping each end of break-away member from the corresponding base support.

First claim

1 . An implantable medical device comprising an electronic controller and an associated power source, a hermetically sealed housing containing the controller and power source, an electrode electrically coupled to the controller and mounted to the housing, a fixation member mounted to a distal end of the housing, and an tethering feature forming a proximal end of the housing, wherein the tethering feature comprises:
a elongate break-away member including deformable ends and a tether attachment zone extending between the ends; and a base including a pair of supports, each deformable end of the break-away member being wrapped around a corresponding support of the pair of supports and being configured to unwrap from the corresponding support when a pull force is applied, in a proximal direction, to the tether attachment zone while an opposing back-up force is applied to the proximal end of the device housing.

2 . The device of claim 1 , wherein the tether attachment zone of the tethering feature break-away member forms a loophole.

3 . The device of claim 1 , wherein each support of the tethering feature base comprises an edge of an aperture that extends through a rim of the base, the rim surrounding an open cavity of the base, and the cavity being spanned by the tether attachment zone of the tethering feature break-away member.

4 . The device of claim 1 , wherein:
the tethering feature base further includes a proximal portion, a distal shoulder, and a necked-in portion that extends between the proximal portion and the distal shoulder; and each deformable end of the break-away member is also wrapped around the necked-in portion of the base.

5 . An interventional medical system comprising an implantable medical device and a delivery catheter for deploying the device to an implant site; the device comprising an electronic controller and an associated power source, a hermetically sealed housing containing the controller and power source, an electrode electrically coupled to the controller and mounted to the housing, a fixation member mounted to a distal end of the housing, and an tethering feature forming a proximal end of the housing; the catheter comprising an elongate shaft and an elongate tether extending within a longitudinally extending lumen of the catheter shaft, a proximal end of the tether extending out from a proximal opening of the shaft lumen, and a looped portion of the tether extending out from a distal opening of the shaft lumen; and wherein:
the catheter shaft includes a flexible distal length terminated by a distal end that defines the distal opening of the lumen, the distal end being configured to abut the proximal end of the tethered device housing; and the device tethering feature comprises:
an elongate break-away member including deformable ends and a tether attachment zone extending between the ends; and
a pair of supports, each deformable end of the break-away member being wrapped around a corresponding support of the pair of supports and being configured to unwrap from the corresponding support, when the tether of the catheter is attached to tether attachment zone of the break-away member, and when a pull force is applied to the tether to pull the tether attachment zone in a proximal direction while an opposing back-up force is applied by the distal end of the catheter shaft abutting the proximal end of the device housing.

6 . The system of claim 5 , wherein the distal end of the catheter shaft is enlarged and configured to surround the break-away member tether attachment zone of the device tethering feature.

7 . The system of claim 6 , wherein the tethering feature break-away member is configured so that, when the deformable ends are unwrapped, the break-away member separates from a remainder of the tethering feature and becomes secured to the catheter by a press fit within the shaft lumen.

8 . The system of claim 5 , wherein the delivery catheter further includes an elongate outer tubular member extending around the shaft in sliding engagement therewith, the outer tubular member including a distal-most portion sized to contain the tethered medical device therein.

9 . The system of claim 5 , further comprising a needle-like member temporarily secured to the looped portion of the tether of the catheter, the needle-like member being configured to pass the looped portion of the tether around the break-away member tether attachment zone of the device tethering feature, for attachment of the tether thereto, and then to be separated from the tether loop.

10 . The system of claim 5 , wherein the tether attachment zone of the break-away member of the device tethering feature forms a loophole.

11 . The system of claim 5 , wherein each support of the base of the device tethering feature comprises an edge of an aperture that extends through a rim of the base, the rim surrounding an open cavity of the base, and the cavity being spanned by the tether attachment zone of the tethering feature break-away member.

12 . The system of claim 5 , wherein:
the base of the device tethering feature further includes a proximal portion, a distal shoulder, and a necked-in portion that extends between the proximal portion and the distal shoulder; and each end of the break-away member of the device tethering feature is also wrapped around the necked-in portion of the base.

13 . A method for deploying a relatively compact implantable medical device to an implant site, the method comprising:
attaching a tether of a delivery catheter to a tethering feature of the device to tether the device to the catheter; loading the tethered device into the delivery catheter such that a distal end of a shaft of the catheter abuts a tethering feature of the device and a distal-most portion of an outer tubular member of the catheter contains the device; maneuvering the distal-most portion of the catheter with the tethered device loaded therein into proximity with the implant site; retracting the outer tubular member of the catheter with respect to the catheter shaft to expose the device for engagement with tissue at the implant site, the outer tubular member being slideably engaged around the catheter shaft; and unwrapping each end of a break-away member of the tethering feature of the engaged device from around a corresponding support of a base of the tethering feature by applying a pull force to the attached tether, thereby separating the break-away member and the tether from the engaged device, the pull force being backed up by the distal end of the catheter shaft abutting the device tethering feature.

14 . The method of claim 13 , further comprising pulling on the tether to secure the separated break-away member of the device tethering feature to the catheter by press fitting the separated break-away member within a lumen of the catheter shaft.

15 . The method of claim 13 , wherein attaching the delivery catheter tether to the device tethering feature comprises:
inserting a needle-like member between the tethering feature break-away member and the tethering feature base to pass a looped portion of the tether around the tether attachment zone of the break-away member; and separating the needle-like member from the looped portion of the tether.

Assignees

• Medtronic Inc

Inventors

• Anderson Thomas A
• Grubac Vladimir
• Jacobs Michael C

Classifications

• A61N1/37205

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

• A61N1/362

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

• A61N1/05

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title

• A61N1/0573

  chacterised by means penetrating the heart tissue, e.g. helix needle or hook · CPC title

• A61N1/37518

  Anchoring of the implants, e.g. fixation · CPC title