Delivery system with projections

• US 9,237,948 B2
• Filed: 07/11/2013
• Issued: 01/19/2016
• Est. Priority Date: 07/11/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Colson, Michael A., Costello, Declan P., O'Connell, Barry
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US13/939,612
• Publication Number:
  US 20150018939A1
• Time in Patent Office: 922 Days
• Field of Search: 623 111- 113, 623/1.23, 623/2.11, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

Delivery systems for delivering medical devices and prosthetic heart valves in a patient'"'"'s body are disclosed. The delivery system may include a catheter-based delivery system. The delivery system may include a tip, a capsule, an inner sheath, and a projection. The delivery system may include an outer sheath and a handle. The delivery system may be configured to be actuated via an actuator disposed on the handle. The projection may include an arm portion and a feeler portion. The feeler portion may include an indentation. The delivery system may be configured to correctly position a medical device or prosthetic heart valve.

Claims

1. A system for delivering a medical device, the system comprising:

a catheter, the catheter comprising;

a tip;

a capsule having a distal end adjacent the tip and being configured to receive a medical device in a collapsed configuration, wherein the capsule is configured to be proximally retracted relative to the tip to release the medical device;

an inner sheath having a distal end that comprises a plurality of projections disposed adjacent the capsule, the inner sheath being disposed to extend along a longitudinal axis of the catheter and the projections being configured to open outwardly relative to an outer surface of the capsule, wherein each projection comprises an arm portion and a feeler portion, the feeler portion having a proximal end adjacent the arm portion and a distal end spaced from the arm portion, wherein at least a portion of the feeler portion is wider than the arm portion; and

an outer sheath disposed along the longitudinal axis of the catheter to slidably extend over the inner sheath, the outer sheath being connected to a handle, the handle further comprising an actuator,

wherein the actuator is configured to actuate the outer sheath relative to the inner sheath to expose the projections and to thereby permit the projections to open outward such that the projections are radially spaced about at least a proximal end of the capsule.

2. The system of claim 1, wherein the projections are asymmetric.

3. The system of claim 1, wherein the projections are configured to be evenly spaced from each other when they open outward.

4. The system of claim 1, wherein the feeler portion has a substantially straight distal end.

5. The system of claim 1, wherein the feeler portion comprises protrusions extending away from the arm portion.

6. The system of claim 1, wherein the distal end of the feeler portion comprises a curved end, and wherein the curved end further comprises a notch.

7. The system of claim 1, wherein the feeler portion is symmetric.

8. The system of claim 1, wherein the feeler portion is asymmetric.

9. The system of claim 1, wherein distal ends of the plurality of projections are unattached to a remainder of the catheter.

10. The assembly of claim 1, wherein the outer sheath is actuated to be proximally retracted relative to the inner sheath to expose the projections and to permit the projections to open outward such that the projections are radially spaced about at least the proximal end of the capsule.

11. The assembly of claim 10, wherein when the outer sheath is proximally retracted such that the projections open outward, the capsule is configured to remain in the same position such that the medical device remains in the collapsed configuration therein.

12. A system for delivering a medical device, the system comprising:

a catheter, the catheter comprising;

a tip;

a capsule adjacent the tip;

an inner sheath adjacent the capsule, the inner sheath being disposed along a longitudinal axis; and

an outer sheath disposed along the longitudinal axis and connected to a handle, the handle further comprising an actuator,

wherein the inner sheath comprises projections distal the handle,

wherein the actuator is configured to actuate the outer sheath,

wherein the capsule is configured to receive a medical device,

wherein the outer sheath is configured to move along the longitudinal axis to expose the projections,

wherein the projections are configured to open outward from the longitudinal axis, and

wherein each projection is uniquely shaped.

13. An assembly for delivering a prosthetic heart valve, the assembly comprising:

a tip;

a capsule configured to receive a prosthetic heart valve in a collapsed configuration therein and configured to be proximally retracted relative to the tip to release the prosthetic heart valve;

an inner sheath comprising a plurality of projections that are configured to extend away from an outer surface of the capsule, the inner sheath being disposed along a longitudinal axis of the assembly, wherein at least one of the plurality of projections further comprises an indentation on a distal most edge, and wherein the projection comprises a shape made from wire; and

an outer sheath being disposed along the longitudinal axis of the assembly over the inner sheath and being coupled to a handle, wherein the handle further includes an actuator that is configured to actuate the outer sheath relative to the inner sheath to expose the projections and to permit the projections to extend away from the outer surface of the capsule.

14. The assembly of claim 13, wherein at least one of the projections is configured to be positioned relative to a native commissure by using fluoroscopic imaging.

15. The assembly of claim 13, wherein at least one of the projections further comprises an asymmetric shape.

16. The assembly of claim 13, wherein distal ends of the plurality of projections are unattached to a remainder of the assembly.

17. The assembly of claim 13, wherein the outer sheath is actuated to be proximally retracted relative to the inner sheath to expose the projections and to permit the projections to extend away from the outer surface of the capsule.

18. The assembly of claim 17, wherein when the outer sheath is proximally retracted such that the projections extend away from the outer surface of the capsule, the capsule is configured to remain in the same position such that the prosthetic heart valve remains in the collapsed configuration therein.