Delivery System with Projections

• US 20150018939A1
• Filed: 07/11/2013
• Published: 01/15/2015
• 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
• Granted Patent: US 9,237,948 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 adjacent the tip;

an inner sheath adjacent the capsule;

the inner sheath being disposed along a longitudinal axis;

an outer sheath disposed along the longitudinal axis and connected to a handle; and

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, and

wherein the projections are configured to open outward from the longitudinal axis.

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

3. The system of claim 1, wherein each projection is uniquely shaped.

4. The system of claim 1, wherein the projections are configured to evenly space from each other when they are rotated outward.

5. The system of claim 1, wherein each projection comprises an arm portion and a feeler portion, the feeler portion having a proximal and distal end.

6. The system of claim 5, wherein the feeler portion has a substantially straight distal end.

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

8. The system of claim 5, wherein the feeler portion comprises a curved end on the distal most end, and wherein the feeler portion further comprises a notch.

9. The system of claim 5, wherein the feeler portion is symmetric.

10. The system of claim 5, wherein the feeler portion is asymmetric.

11. A method of delivering a prosthetic heart valve, the method comprising:

advancing a delivery system into a patient'"'"'s heart having native commissures, the delivery system comprising;

a catheter, the catheter comprising;

a tip;

a capsule adjacent the tip;

an inner sheath adjacent the capsule; and

the inner sheath being disposed along a longitudinal axis;

an outer sheath configured to move along the longitudinal axis and connected to a handle;

the handle further comprising an actuator;

the inner sheath having a proximal end and a distal end; and

the inner sheath being disposed along a longitudinal axis;

wherein the inner sheath comprises projections proximal the capsule,

wherein the projections are configured to rotate outward from the longitudinal axis,

wherein the actuator is configured to actuate the outer sheath, and

wherein the capsule contains a prosthetic heart valve configured to collapse to a collapsible state and expand to an expanded state,

retracting the outer sheath;

advancing the projections proximate the capsule;

causing the projections to rotate outward from the longitudinal axis;

expanding the prosthetic heart valve to an expanded state; and

anchoring the prosthetic heart valve in the patient'"'"'s heart.

12. The method of claim 11, wherein the projections further comprise an arm portion and a feeler portion, the method further comprising using the projections to position the prosthetic heart valve.

13. The method of claim 12, the method further comprising using the projections to position the prosthetic heart valve by aligning a portion of the feeler portion of one projection with a portion of the patient'"'"'s heart.

14. The method of claim 12, wherein the feeler portion of one projection further comprises a notch, the method further comprising using the projections to position the prosthetic heart valve by aligning the notch of the projection with a portion of the patient'"'"'s heart.

15. The method of claim 12, wherein the feeler portion of one projection further comprises a channel, the method further comprising using the projections to position the prosthetic heart valve by aligning the channel of one projection with a portion of the patient'"'"'s heart.

16. The method of claim 11, wherein the method further comprising generating a fluoroscopic image positioning the prosthetic heart valve based on the position of one projection relative to a portion of the patient'"'"'s heart.

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

a tip;

a capsule adjacent the tip;

an inner sheath adjacent the capsule;

the inner sheath being disposed along a longitudinal axis;

an outer sheath being disposed along the longitudinal axis;

a handle coupled to the outer sheath; and

the handle further comprising an actuator;

wherein the inner sheath comprises a projection distal the handle,

wherein the actuator is configured to actuate the outer sheath,

wherein the capsule is configured to receive a prosthetic heart valve,

wherein the outer sheath is configured to expose the projection, and

wherein the projection is configured to extend away from the longitudinal axis.

18. The assembly of claim 17, wherein the projection further comprises an indentation on the distal end, and wherein the projection comprises a shape made from wire.

19. The assembly of claim 17, wherein the projection is configured to be positioned relative to a native commissure by using fluoroscopic imaging.

20. The assembly of claim 17, wherein the projection further comprises an asymmetric shape.