Anchor sleeve deployment for implantable medical devices

• US 10,035,001 B2
• Filed: 08/10/2016
• Issued: 07/31/2018
• 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 M
• Application Number:
  US15/232,937
• Publication Number:
  US 20160346516A1
• Time in Patent Office: 720 Days
• Field of Search: 606108, 606129, 604175
• 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
• 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. A method for deploying an anchor sleeve onto an elongate body of an implantable medical device, the method comprising:

inserting a distal portion of an introducer shaft into a body of a patient, the inserted distal portion providing percutaneous access to an implant site through a lumen of the shaft;

simultaneously inserting the body of the device through the lumen of the introducer shaft and through a lumen of a deployment tool, the tool being mounted around a proximal portion of the introducer shaft;

simultaneously advancing the inserted body of the device through the lumen of the introducer shaft, and through a lumen of the anchor sleeve, to the implant site, the anchor sleeve being mounted around the proximal portion of the introducer shaft; and

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;

wherein the held deployment tool contacts the anchor sleeve to hold the anchor sleeve in place, relative to the advanced body of the device, while the introducer shaft is pulled proximally; and

after the introducer shaft has been pulled out from the body of the patient, the anchor sleeve is deployed onto the advanced body.

2. The method of claim 1, further comprising mounting the deployment tool and the anchor sleeve around the proximal portion of the introducer shaft.

3. The method of claim 2, wherein mounting the deployment tool around the proximal portion of the introducer shaft comprises mating the deployment tool with a hub of the introducer shaft, the hub terminating the proximal portion of the shaft.

4. The method of claim 2, wherein mounting the anchor sleeve and the deployment tool around the proximal portion of the introducer shaft comprises sliding the shaft through the lumen of the deployment tool, and then sliding the shaft through the lumen of the anchor sleeve.

5. The method of claim 2, wherein:

a dilator extends within the lumen of the introducer shaft, such that a distal tip of the dilator protrudes from a distal end of the shaft, prior to inserting and advancing the body of the device through the lumen of the shaft; and

mounting the anchor sleeve around the proximal portion of the introducer shaft comprises inserting the distal tip of the dilator through the lumen of the anchor sleeve, and then inserting the shaft through the lumen of the anchor sleeve.

6. The method of claim 1, further comprising removing the introducer shaft and the deployment tool, together, from around the advanced body of the device, after the introducer shaft has been pulled out from the body of the patient.