Crimping device and method for loading stents and prosthetic heart valves

• US 10,709,591 B2
• Filed: 06/06/2017
• Issued: 07/14/2020
• Est. Priority Date: 06/06/2017
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Fox, Jason, Trask, David
• Primary Examiner(s): Cozart, Jermie E
• Application Number:
  US15/615,144
• Publication Number:
  US 20180344490A1
• Time in Patent Office: 1,134 Days
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B21D 39/046 Connecting tubes to tube-like fittings
• CPC Class Codes: B23P 11/025 by using heat or cold
• CPC Class Codes: B23P 19/02 for connecting objects by press fit or for detaching same B23P19/10 takes precedence
• CPC Class Codes: H01R 43/04 for forming connections by deformation, e.g. crimping tool
• CPC Class Codes: H01R 43/048 Crimping apparatus or processes H01R43/042 takes precedence
• CPC Class Codes: Y10T 29/53657 to apply or remove a resilient article [e.g., tube, sleeve, etc.]

Abstract

Systems and devices for crimping a medical device and associated methods are disclosed herein. A crimping device configured in accordance with embodiments of the present technology can include, for example, a frame including a stationary plate, a movable member, and a plurality of blades arranged to form a channel and each including a pin that projects through a slot on the movable member and a corresponding slot on the stationary plate. The crimping device can be actuated to move the movable member relative to the stationary plate to drive the pins along paths defined by the slots to thereby drive the blades radially inward to crimp a medical device positioned within the channel.

Claims

1. A crimping device comprising:

a stationary plate having a plurality of individual first slots;

a movable member having a plurality of individual second slots, wherein the individual second slots are aligned with a portion of the corresponding individual first slots;

a plurality of movable blades arranged circumferentially to form a channel having a central axis extending therethrough, wherein—

each blade has a first end portion and a second end portion, and wherein the second end portion is radially farther from the central axis than the first end portion,

each blade includes a pin projecting from the second end portion of the blade, and

each pin extends through one of the first slots and a corresponding one of the second slots; and

an actuator device operably coupled to the movable member and configured to move the movable member relative to the stationary plate, wherein movement of the movable member drives the plurality of pins along a path defined by the first and second slots such that the plurality of blades move radially inward to decrease a diameter of the channel, and wherein the radial inward movement of the blades is configured to reduce a diameter of a medical device positioned within the channel to accommodate sizing of a delivery capsule for implanting the medical device using a minimally invasive procedure.

2. The crimping device of claim 1 wherein the blades include a first side and a second side facing away from the first side, the stationary plate is a first stationary plate facing the first side of the blades, the movable member is a first movable member facing the first side of the blades, and each pin is a first pin on the first side of each blade, and wherein the crimping device further comprises:

a second stationary plate facing the second side of the blades, the second stationary plate having a plurality of third slots;

a second movable member facing the second side of the blades, the second movable member having a plurality of fourth slots,

wherein—

each blade includes a second pin projecting from the second end portion on the second side of the blade,

each second pin extends through one of the third slots and a corresponding one of the fourth slots, and

the actuator device is operably coupled to the first and second movable members and configured to move the first and second movable members relative to the first and second stationary plates to thereby actuate the plurality of blades to vary the diameter of the channel.

3. The crimping device of claim 1 wherein the second slots define an arcuate path with a first end and a second end spaced closer to the channel than the first end.

4. The crimping device of claim 1 wherein the diameter of the channel varies along the central axis.

5. The crimping device of claim 1 wherein the blades have inner surfaces that define the channel, and wherein the inner surfaces are shaped such that the channel has a generally funnel shape.

6. The crimping device of claim 1 wherein the plurality of blades includes twelve blades.

7. The crimping device of claim 1, wherein—

the movable member has a first position in which the channel has a maximum diameter,

the movable member has a second position in which the channel has a minimum diameter, and

the pins are positioned radially farther from the central axis in the first position than in the second position.

8. The crimping device of claim 1, further comprising:

a frame; and

a holder removably coupled to the frame and configured to hold the medical device within the channel as the blades reduce the diameter of the medical device.

9. The crimping device of claim 8 wherein—

the movable member has a first position and a second position,

the channel has a smaller diameter in the second position than in the first position, and

the holder includes a plurality of fingers configured to engage a portion of the medical device in the first position and configured to disengage from the portion of the medical device in the second position.

10. The crimping device of claim 1 wherein the first slots define a straight path that extends radially away from the central axis.

11. The crimping device of claim 1 wherein the second slots have a length that is longer than a length of the first slots.

12. The crimping device of claim 1 wherein the first slots and second slots are equally spaced angularly around the central axis.

13. The crimping device of claim 1, further comprising a connector coupled to the movable member and having a threaded hole extending therethrough, wherein:

the movable member is a rotatable member,

the actuator device is a threaded shaft and extends through the threaded hole of the connector, and

wherein, to actuate the rotatable member, the actuator device is configured to rotate the threaded shaft about a longitudinal axis of the shaft such that the connector moves along the shaft.

14. The crimping device of claim 1 wherein the channel is configured to receive a prosthetic heart valve device for implantation into a native mitral valve, and wherein the blades are configured to reduce an outer diameter of the prosthetic heart valve device from 1.300 inches to 0.4 inch or less.

15. A system for reducing a size of a stent device, the system comprising:

a crimping device including;

a frame having a stationary plate having a plurality of first slots,

a movable member having a plurality of second slots, wherein the movable member is movable with respect to the stationary plate,

a plurality of movable blades arranged circumferentially to define a channel having a central axis extending therethrough, wherein;

the channel is configured to receive a prosthetic heart valve device in an unexpanded state, the prosthetic heart valve device including the stent device,

the movable member is between the blades and the stationary plate,

each blade has a first end portion and a second end portion spaced radially farther from the central axis than the first end portion,

each blade includes a pin projecting from the second end portion and extending through one of the first slots and a corresponding one of the second slots, and

an actuator device configured to move the movable member to drive the plurality of blades between a first position in which the channel has a first cross-sectional dimension to a second position in which the channel has a second cross-sectional dimension smaller than the first cross-sectional dimension, wherein moving the blades from the first position to the second position decreases an outer dimension of the stent device, and wherein the first slots are configured to maintain relative position between the blades as the blades move between the first and second positions; and

a holder removably coupled to the frame and configured to hold the stent device within the channel when the blades are in the first position.

16. The system of claim 15 wherein the blades are configured to continuously compress the prosthetic heart valve device as the blades move from the first position to the second position.

17. The system of claim 15 wherein the channel has a funnel shape.

18. The system of claim 15, further comprising a tray defining a reservoir that is configured to receive the crimping device therein.

19. The system of claim 18 wherein the reservoir is configured to hold a chilled liquid therein, and wherein the liquid fills the channel when the crimping device is positioned within the reservoir.

20. The system of claim 18 wherein the tray includes an aperture extending through the tray to the reservoir, wherein the channel of the crimping device is accessible via the aperture to permit the prosthetic heart valve device to be positioned within the channel.

21. The system of claim 15 wherein—

the holder includes a plurality of fingers configured to engage attachment features of the prosthetic heart valve device in the first position; and

the blades are sized and shaped to press against the fingers as the blades move from the first position to the second position to disengage the attachment features from the holder.

22. The system of claim 15 wherein, in the first position, the pins are positioned radially farther from the central axis of the channel than in the second position.

23. A method for reducing a size of a medical device for loading into a delivery capsule, the method comprising:

positioning the medical device within a channel of the crimping device, wherein;

the channel is defined by a plurality of movable blades arranged circumferentially around a central axis of the channel,

each blade includes a pin projecting from an end portion of the blade spaced radially apart from the channel, and

each pin projects through a corresponding first slot on a stationary plate and a corresponding second slot on a movable member positioned between the stationary plate and the blades, wherein the stationary plate comprises a plurality of first slots and the movable member comprises a plurality of second slots; and

driving the blades radially inwardly from a first position to a second position to reduce a cross-sectional dimension of the channel, thereby reducing an outer diameter of the medical device, wherein driving the blades includes moving the movable member relative to the stationary plate to move the pins along individual arcuate paths defined by the corresponding second slots.

24. The method of claim 23 wherein driving the blades radially inwardly comprises driving the blades from the first position in which the channel has a minimum cross-sectional dimension of at least 1.300 inches to the second position in which the channel has a minimum cross-sectional dimension of at most 0.4 inch.

25. The method of claim 23 wherein driving the blades radially inwardly comprises moving each pin from a first end of the arcuate path toward a second end of the arcuate path, wherein the second end is closer to the central axis of the channel than the first end.

26. The method of claim 23 wherein driving the blades radially inwardly comprises continuously compressing the medical device.

27. The method of claim 23 wherein the medical device is a prosthetic heart valve device, and wherein the method further comprises:

removably coupling a plurality of engagement features of the prosthetic heart valve device to a corresponding plurality of fingers of a holder, wherein the holder retains the prosthetic heart valve device while the blades are in the first position; and

wherein driving the blades radially inwardly presses the blades against outer surfaces of the fingers to disengage the engagement features from the holder.

28. The method of claim 23 wherein the blades have inner surfaces that define the channel, wherein the inner surfaces are shaped such that the channel has a generally funnel shape, and further comprising:

after driving the blades to the second position, moving the medical device through the channel toward the delivery capsule to further reduce an outer diameter of the medical device.

29. The method of claim 23, further comprising submerging the crimping device in a liquid such that the medical device is submerged when positioned within the channel.