Delivery system for deployment of medical devices

• US 8,986,361 B2
• Filed: 10/17/2008
• Issued: 03/24/2015
• Est. Priority Date: 10/17/2008
• Status: Active Grant

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Pannek, Edward, Brtlein, Georg
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/253,858
• Publication Number:
  US 20100100167A1
• Time in Patent Office: 2,349 Days
• Field of Search: 623/1.11, 623/2.11, 623/1.12, 623/1.23
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A sheathed catheter system is described where the sheath comprises a distal portion and a proximal portion that are moveable axially relative to each other, and relative to a tube carrying a medical device thereon. The distal and proximal sheath portions can be brought together in order to enclose therewithin the medical device. The distal sheath has a proximal section that is configured to bias radially inwardly to minimize an otherwise exposed annular surface catching on protruding surfaces that may exist on the catheter or other medical tool in use at the time, or to minimize scraping the inner native lumen of the patient upon retrieval.

Claims

1. An apparatus for minimally invasively delivering a medical device to a target site within a patient, the apparatus comprising:

a first tube having an outside surface suitable for accepting the medical device collapsed thereon in a stationary position; and

a sheath including first and second portions that may be moved axially relative to each other and with respect to the first tube, the sheath portions configured so as to enclose the medical device collapsed onto the first tube when brought together, and configured to expose the medical device when directed away from each other, the first sheath portion including a proximal edge,

wherein the proximal edge is elastically expandable from a first diameter to a second diameter, and

wherein the proximal edge is biased radially inwardly to the first diameter when unconstrained such that the first sheath portion tapers proximally toward the first tube to reduce a profile thereof, and

wherein the proximal edge is held at the second diameter by the medical device collapsed onto the first tube.

2. The apparatus of claim 1, wherein the first tube includes a hub.

3. The apparatus of claim 2, wherein the first sheath portion is configured so as to enclose at least a portion of the hub.

4. The apparatus of claim 1, wherein either the first and/or second sheath portion is configured to invert upon itself.

5. An apparatus for minimally invasively delivering a medical device to a target site within a patient, the apparatus comprising:

a first tube having an outside surface suitable for accepting the medical device collapsed thereon in a stationary position, the first tube including a hub for retaining at least a portion of the medical device on the first tube,

wherein the hub includes a generally extended non-tapered portion, and

wherein the hub includes at least one button configured to retain the medical device on the hub until full deployment of the medical device; and

a sheath including first and second portions that may be moved axially relative to each other and with respect to the first tube, the sheath portions configured so as to enclose the medical device collapsed onto the first tube when brought together, and configured to expose the medical device when directed away from each other,

wherein the first sheath portion includes an elastically expandable proximal edge that is biased radially inwardly against the medical device collapsed onto the first tube when the sheath portions enclose the medical device, and

wherein, during operation, when the first sheath portion is moved in a direction sufficient to expose the medical device the elastically expandable proximal edge is biased radially inwardly against the extended non-tapered portion of the hub and tapers proximally toward the first tube to maintain a low profile.

6. An apparatus for delivering a medical device to a target site within a patient via a body lumen, the apparatus comprising:

an inner tube;

a distal sheath portion attached to the inner tube;

an intermediate tube, moveable over the inner tube and at least partially into the distal sheath portion;

an outer tube, moveable over the intermediate tube;

a proximal sheath portion attached to the outer tube, so that, in use, the proximal sheath portion and the distal sheath portion can be moved together to substantially cover the medical device mounted on the intermediate tube and moved apart to deploy the medical device;

the distal sheath portion having an elastic proximal edge biased radially inwardly to a first diameter when unconstrained such that the distal sheath portion tapers proximally toward the inner tube to reduce a profile thereof and the distal sheath portion being configured to expand from the first diameter to a second diameter to cover the medical device.

7. The apparatus for delivering a medical device of claim 6, wherein the proximal edge is tapered inwardly.

8. The apparatus for delivering a medical device of claim 6, wherein the proximal edge is pleated.

9. The apparatus for delivering a medical device of claim 6, wherein the proximal edge is beveled.

10. An apparatus for delivering a medical device to a target site within a patient via a body lumen, the apparatus comprising:

an inner tube;

a distal sheath portion attached to the inner tube,

wherein the distal sheath portion includes an elastic proximal edge biased radially inwardly to a first diameter when unconstrained such that the distal sheath portion tapers proximally toward the inner tube to reduce a profile thereof and the elastic proximal edge being expandable from the first diameter to a second diameter to cover the medical device;

an intermediate tube, moveable over the inner tube and at least partially into the distal sheath portion, the intermediate tube having a hub at its distal end and having a region on the intermediate tube proximal of the hub for mounting the medical device,

wherein the region for mounting the medical device includes at least one button configured to retain the medical device on the hub until full deployment of the medical device;

an outer tube, moveable over the intermediate tube; and

a proximal sheath portion attached to the outer tube, so that, in use, the proximal sheath portion and the distal sheath portion can be moved together to substantially cover the medical device mounted on the intermediate tube and moved apart to deploy the medical device;

the hub having an axial length sufficient to permit the medical device to be deployed while the distal sheath portion covers at least part of the hub.

11. The apparatus for delivering a medical device of claim 10, wherein the hub comprises a substantially cylindrical outer surface over which the distal sheath portion can reside until the medical device is deployed.