Implantable medical device delivery system

• US 10,406,011 B2
• Filed: 04/28/2016
• Issued: 09/10/2019
• Est. Priority Date: 04/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Le, Tony
• Primary Examiner(s): Szpira, Julie A
• Application Number:
  US15/140,881
• Publication Number:
  US 20170312109A1
• Time in Patent Office: 1,230 Days
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A system for delivering an implantable medical device to a treatment site within a patient includes an implantable medical device including a rigid body, and a delivery device. The delivery device includes an elongated catheter shaft and an expandable balloon connected to the elongated catheter shaft adjacent a distal end of the elongated catheter shaft, where the expandable balloon includes a proximal region, a distal region, and an implant retaining portion disposed between the proximal region and the distal region. The delivery device also includes a compression element connected to the implant retaining portion of the expandable balloon, where the compression element is adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated. At least a portion of the compression element and the implant retaining portion are disposed within a lumen of the implantable medical device.

Claims

1. A system for delivering an implantable medical device to a treatment site within a patient, comprising:

an implantable medical device comprising a rigid body;

a delivery device comprising;

an elongated catheter shaft comprising a proximal end and a distal end, wherein the elongated catheter shaft defines a longitudinal axis extending between the proximal end and the distal end;

an expandable balloon connected to the elongated catheter shaft adjacent the distal end of the elongated catheter shaft, wherein the expandable balloon comprises a proximal region, a distal region, and an implant retaining portion disposed between the proximal region and the distal region; and

a compression element connected to the implant retaining portion of the expandable balloon, wherein the compression element is adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated;

wherein the implantable medical device is connected to the delivery device such that at least a portion of the compression element and at least a portion of the implant retaining portion of the expandable balloon are disposed within a lumen defined by the rigid body of the implantable medical device, and further wherein the compression element is adapted to prevent the expandable balloon from expanding within the lumen of the rigid body of the implantable medical device.

2. The system of claim 1, wherein a longitudinal length of the compression element is equal to or greater than a longitudinal length of the rigid body of the implantable medical device such that the compression element extends along at least the entire lumen of the rigid body.

3. The system of claim 1, further comprising a sheath disposed over at least a portion of the elongated catheter shaft, wherein the sheath is adapted to engage the medical device and maintain the medical device in place as the expandable balloon and compression element are withdrawn through the lumen of the rigid body of the medical device.

4. The system of claim 3, wherein the sheath is further adapted such that the expandable balloon and compression element can be withdrawn through a lumen defined by the sheath.

5. The system of claim 1, wherein a diameter of the distal region of the expandable balloon adjacent a distal end of the implantable medical device is greater than an outer diameter of the distal end of the medical device when the expandable balloon is at least partially inflated.

6. The system of claim 1, wherein a diameter of the proximal region of the expandable balloon adjacent a proximal end of the implantable medical device is greater than an outer diameter of the proximal end of the medical device when the expandable balloon is at least partially inflated.

7. The system of claim 1, wherein the compression element comprises tubing.

8. The system of claim 1, wherein the implantable medical device comprises at least one of a hydroxyl-appetite calcium tube, a bone plug, a biostable tube, a bioabsorbable tube, a drug-coated shell, and a metal tube.

9. The system of claim 1, wherein a cross-sectional area of the distal region of the expandable balloon decreases in a distal direction along the longitudinal axis.

10. The system of claim 1, further comprising a therapeutic agent disposed on a surface of the expandable balloon.

11. The system of claim 1, wherein a maximum volume of the distal region of the expandable balloon is greater than a maximum volume of the proximal region of the expandable balloon.

12. The system of claim 1, wherein the expandable balloon is adapted to be deflated and withdrawn through the lumen of the rigid body of the implantable medical device, thereby leaving the medical device in place at the treatment site.

13. The system of claim 1, wherein the elongated catheter shaft further comprises an inflation lumen disposed along the longitudinal axis that is in fluid communication with the expandable balloon.

14. The system of claim 1, wherein the elongated catheter shaft further comprises a guidewire lumen disposed along the longitudinal axis.

15. A system for delivering an implantable medical device to a treatment site within a patient, comprising:

an implantable medical device comprising a rigid body;

a delivery device comprising;

an elongated catheter shaft comprising a proximal end and a distal end, wherein the elongated catheter shaft defines a longitudinal axis extending between the proximal end and the distal end;

an expandable balloon connected to the elongated catheter shaft adjacent the distal end of the elongated catheter shaft, wherein the expandable balloon comprises a proximal region, a distal region, and an implant retaining portion disposed between the proximal region and the distal region; and

a compression element connected to the implant retaining portion of the expandable balloon, wherein the compression element is adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated;

wherein the implantable medical device is connected to the delivery device such that at least a portion of the compression element and at least a portion of the implant retaining portion of the expandable balloon are disposed within a lumen defined by the rigid body of the implantable medical device; and

wherein a diameter of the distal region of the expandable balloon adjacent a distal end of the implantable medical device is greater than an outer diameter of the distal end of the medical device when the expandable balloon is at least partially inflated.