Anchor sleeve deployment for implantable medical devices

• US 9,433,756 B2
• Filed: 08/04/2014
• Issued: 09/06/2016
• Est. Priority Date: 08/09/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Oster, Daniel C.
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US14/450,923
• Publication Number:
  US 20150045807A1
• Time in Patent Office: 764 Days
• Field of Search: 606/108, 606/129, 606/175
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

An introducer assembly that may be employed to implant a medical device includes an introducer shaft, and an anchor sleeve and a deployment tool mounted on the shaft. According to some methods, the sleeve is deployed onto an elongate body of the medical device, after the body has been advanced through a lumen of the introducer shaft and to an implant site within a body of a patient, by pulling the introducer shaft proximally, out from the body of the patient, while holding the deployment tool in place, relative to the advanced body of the device.

Claims

1. An introducer assembly for an elongate implantable medical device, the assembly comprising:

an elongate introducer shaft extending between a proximal end thereof and a distal end thereof, the shaft including a hub, formed at the proximal end thereof, and a lumen extending along a length thereof, the lumen having a proximal opening formed in the hub and a distal opening formed at the distal end, and the distal end having a tapered profile;

a deployment tool including a relatively rigid sidewall and being mounted around the introducer shaft, in proximity to the hub, the deployment tool extending between a proximal end thereof and a distal end thereof, and the relatively rigid sidewall being configured to support an external force that holds the deployment tool in place while the introducer shaft is moved relative thereto;

an anchor sleeve mounted around the introducer shaft at a location in proximity to the mounted deployment tool, such that the mounted deployment tool is located between the hub of the introducer shaft and the mounted anchor sleeve; and

a retaining feature that couples the introducer shaft to the deployment tool;

wherein the distal end of the mounted deployment tool is configured to contact a proximal end of the mounted anchor sleeve, when the external force holds the deployment tool in place and the introducer tool is pulled in a proximal direction, relative to the deployment tool;

the contact of the mounted deployment tool against the proximal end of the mounted anchor sleeve, in conjunction with the external force holding the deployment tool in place, allows the introducer shaft to be pulled in the proximal direction relative to the anchor sleeve, so that the sleeve is deployed therefrom; and

the retaining feature continues to couple the introducer shaft to the deployment tool after the shaft is pulled proximally relative to the deployment tool, and when there is adequate separation between the tool and the hub of the shaft for the anchor sleeve to be deployed from the shaft.

2. The assembly of claim 1, wherein the proximal end of the deployment tool mates with the hub of the introducer shaft, and is releasable therefrom when the external force holds the deployment tool in place, and when the introducer shaft is pulled in the proximal direction.

3. The assembly of claim 1, wherein the external force is applied by fingers of an operator, and an external surface of the deployment tool is configured to receive the fingers.

4. The assembly of claim 1, wherein the introducer shaft comprises a polymer tube, and further includes a dilator slidably engaged within the lumen thereof, the dilator having a distal tip protruding from the distal opening of the lumen of the shaft.

5. The assembly of claim 1, wherein the introducer shaft includes a lubricious interface with the deployment tool and/or the anchor sleeve.

6. The assembly of claim 1, wherein the deployment tool includes a lubricious liner interfacing with the introducer shaft.

7. The assembly of claim 1, wherein the retaining feature comprises a cord with enough length to allow the adequate separation.

8. The assembly of claim 1, wherein the retaining feature comprises an elastic member that stretches to a length that allows the adequate separation.

9. The assembly of claim 1, wherein the retaining feature comprises a recessed track, formed in an exterior surface of a wall of the introducer shaft, and an inward projecting tooth, formed in a wall of the deployment tool and mating with the track, the track being terminated just proximal to the distal end of the shaft to form a stop for the tooth.

10. The assembly of claim 1, wherein the introducer shaft comprises a metal needle.

11. An introducer assembly for an elongate implantable medical device, the assembly comprising:

an elongate introducer shaft extending between a proximal end thereof and a distal end thereof, the shaft including a hub, formed at the proximal end thereof, and a lumen extending along a length thereof, the lumen having a proximal opening formed in the hub and a distal opening formed at the distal end, and the distal end having a tapered profile;

a deployment tool including a relatively rigid sidewall and being mounted around the introducer shaft, in proximity to the hub, the deployment tool extending between a proximal end thereof and a distal end thereof, and the relatively rigid sidewall being configured to support an external force that holds the deployment tool in place while the introducer shaft is moved relative thereto; and

an anchor sleeve mounted around the introducer shaft at a location in proximity to the mounted deployment tool, such that the mounted deployment tool is located between the hub of the introducer shaft and the mounted anchor sleeve;

wherein the distal end of the mounted deployment tool is configured to contact a proximal end of the mounted anchor sleeve, when the external force holds the deployment tool in place and the introducer tool is pulled in a proximal direction, relative to the deployment tool;

the contact of the mounted deployment tool against the proximal end of the mounted anchor sleeve, in conjunction with the external force holding the deployment tool in place, allows the introducer shaft to be pulled in the proximal direction relative to the anchor sleeve, so that the sleeve is deployed therefrom; and

the introducer shaft comprises a metal needle.

12. The assembly of claim 11, further comprising a retaining feature that couples the introducer shaft to the deployment tool after the shaft is pulled proximally, relative to the deployment tool, and when there is adequate separation between the tool and the hub of the shaft for the anchor sleeve to be deployed from the shaft.

13. The assembly of claim 12, wherein the proximal end of the deployment tool mates with the hub of the introducer shaft, and is releasable therefrom when the external force holds the deployment tool in place, and when the introducer shaft is pulled in the proximal direction.