TEMPERATURE-CONTROL DURING CRIMPING OF AN IMPLANT

Abstract

An assembly (10) for crimping a frame (56) of an implant (58) comprises a crimping device (20) with a base (22) and a crimping mechanism (24) that defines a crimping aperture (26). A bath (28) having a floor (30), and one or more side-walls (32) extending upward from the floor to a side-wall height defines a receptacle (18) that is shaped to receive a portion of the crimping device. The apparatus has an assembled state in which the portion of the crimping device has been received by the receptacle, the crimping device is held securely by the bath, and the aperture is below the side-wall height. Other embodiments are also described.

Claims

1-24. (canceled)

25. Apparatus for crimping a frame of an implant, the apparatus comprising a crimping assembly, the crimping assembly comprising: a bath having a floor, and one or more side-walls extending upward from the floor to a side-wall height; and a crimping mechanism that defines a crimping aperture, the crimping mechanism attached to the bath such that the crimping aperture is disposed within the bath below the side-wall height, wherein: the crimping aperture has an open state and a narrowed state, the crimping mechanism further comprises a handle, the crimping mechanism being actuatable by moving the handle circumferentially around the crimping mechanism, and actuation of the crimping mechanism transitions the crimping aperture from the open state to the narrowed state.

26. The apparatus according to claim 25, wherein: the crimping mechanism has a first side and a second side, and the bath has an internal width sufficient to allow a human operator to simultaneously place a first hand inside the bath on the first side of the crimping mechanism, and a second hand inside the bath on the second side of the crimping mechanism.

27. The apparatus according to claim 25, wherein the crimping mechanism has a thickness, and wherein the bath has an internal width that is 16-24 cm greater than the thickness of the crimping mechanism.

28-35. (canceled)

36. A system comprising the apparatus according to claim 25, wherein the system further comprises the implant, and wherein the frame of the implant is tubular and: (i) circumscribes a longitudinal axis, (ii) defines a radial diameter, and (iii) has a crimped state and a non-crimped state, in which the radial diameter of the frame in the crimped state is smaller than the radial diameter of the frame in the non-crimped state.

37. The system according to claim 36, wherein the implant is a prosthetic heart valve or vascular stent.

38. (canceled)

39. The apparatus according to claim 25, wherein: the crimping mechanism has a working diameter, defined between a first position of an end of the handle when the crimping aperture is in the open state, and a second position of the end of the handle when the crimping aperture is in the narrowed state, and the bath has an internal width that is greater than the working diameter.

40. The apparatus according to claim 39, wherein the internal width of the bath is less than 5 cm greater than the working diameter of the crimping mechanism.

41. The apparatus according to claim 40, wherein the internal width of the bath is less than 2 cm greater than the working diameter of the crimping mechanism.

42. The apparatus according to claim 41, wherein the internal width of the bath is 1-10 mm greater than the working diameter of the crimping mechanism.

43. The apparatus according to claim 25, wherein the handle is below the side-wall height in both the open state and the narrowed state.

44. The apparatus according to claim 43, wherein during transitioning of the crimping aperture from the open state to the narrowed state, the handle is temporarily elevated above the side-wall height.

45-64. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0131] FIGS. 1A-C are schematic illustrations of a crimping assembly, comprising a crimping device and a bath, in accordance with some applications of the invention;

[0132] FIGS. 2A-E are schematic illustrations showing a crimping assembly being used in combination with a delivery tool to crimp a frame of an implant, in accordance with some applications of the invention;

[0133] FIG. 3 is a schematic illustration of a seal connected by a cap to an external portion of a port, in accordance with some applications of the invention;

[0134] FIGS. 4A-E are schematic illustrations showing the use of a delivery tool with a cap, the port, and a plurality of plugs, in accordance with some applications of the invention;

[0135] FIG. 5 is a schematic illustration showing sealing of the port around a delivery tool shaft, in accordance with some applications of the invention; and

[0136] FIGS. 6A-B are schematic illustrations showing use of the crimping device disposed within the bath, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

[0137] Reference is made to FIGS. 1A-C, which are schematic illustrations of a crimping assembly 10, comprising a crimping device 20 and a bath 28, in accordance with some applications of the invention.

[0138] Crimping device 20 comprises a base 22, and a crimping mechanism 24 that defines a crimping aperture 26 having an open state shown in FIGS. 2B, 2C & 6A, as well as a narrowed state shown in FIGS. 2D and 6B. Bath 28 has a floor 30, and one or more side-walls 32 extending upward from the floor to a side-wall height D34. Typically, side-wall height D34 is the height to which bath 28 is fillable with a liquid, e.g., the lowest height of the one or more side-walls. Bath 28 defines a receptacle 18 that is shaped to receive a portion of crimping device 20, such that the crimping device is held securely by the bath 28.

[0139] FIGS. 1A-2E show crimping assembly 10 in its assembled state, in which crimping device 20 is disposed within bath 28, and is held securely by the bath. In the assembled state, the aperture 26 is below side-wall height D34. Typically, and as shown, the receptacle 18 is a recess in floor 30 of bath 28, and the recess is shaped to snugly receive base 22 of crimping device 20.

[0140] Typically, and as shown, bath 28 includes a port-defining side-wall 36, which defines a port 38 that defines a channel 50 between outside of the bath and inside of the bath. Typically, in the assembled state port 38 is aligned with crimping aperture 26. For example, a height D35 of the aperture may be within 1 cm of a height D33 of the port. Alternatively or additionally, port 38 may be disposed in a rotational position of the aperture that is within 5 degrees of a rotational position of the port 38. This alignment typically places channel 50 and aperture 26 along a co-linear axis 40 (FIG. 1A).

[0141] For some applications, crimping assembly 10 comprises two or more separable components, which undergo assembly prior to use. For example, bath 28 and crimping device 20 may be provided as separate components, which are assembled prior to use, e.g., by the operator or by a technician. For such applications, assembly 10 is typically assembled by introducing a portion of the crimping device (e.g., base 22) into receptacle 18 (FIG. 1A).

[0142] Typically, and as shown, bath 28 is shaped to receive crimping device 20 in a pre-defined rotational orientation of the crimping device with respect to the bath, and receptacle 18 and the portion of the crimping device (e.g., base 22) are cooperatively shaped to inhibit, in the assembled state, rotation of the crimping device 20 from the pre-defined rotational orientation. For example, and as shown, receptacle 18 may define a protrusion 52, and device 20 (e.g., base 22 thereof) may be shaped to define a notch 54 (or vice versa), the protrusion being disposed within the notch.

[0143] It is to be noted that the scope of the invention includes the use of other features to securely hold crimping device 20 within bath 28. For example, complementary couplings such as catches and/or locks may be used.

[0144] For other applications, crimping assembly 10 may be provided pre-assembled, with crimping device 20 already secured within bath 28. For some such applications, device 20 does not comprise a distinct base 22. Aside from these differences, the pre-assembled crimping assembly is typically as described hereinabove.

[0145] Reference is now also made to FIGS. 6A-B, which are schematic illustrations of crimping assembly 10, in accordance with some applications of the invention. Crimping mechanism 24 has a working radius D80 from the center of aperture 26 to the end of handle 25. For some applications, during the operation of crimping mechanism 24, handle 25 revolves about halfway circumferentially around mechanism 24 (i.e., with respect to aperture 26). Therefore, crimping mechanism 24 defines a working diameter D82, defined as twice working radius D80.

[0146] Bath 28 has an internal width D84, measured at height D33, typically transverse to axis 40. Typically, and as shown in FIG. 1B, internal width D84 is greater than working diameter D82. Typically, D84 is less than 10 cm greater than D82, (e.g., less than 5 cm greater, less than 2 cm greater, e.g., 1-10 mm greater).

[0147] Crimping mechanism 24 has a thickness D88. Thickness D88 is typically 2-5 cm (e.g., 2-3 cm). Typically, and as shown in FIG. 1B, bath 28 has another internal width D86, measured at height D33, measured along axis 40. For some applications, width D86 is sufficiently great that an operator may place a hand on each side of crimping mechanism 24 in order to load the implant onto the tool. Therefore, for some applications, width D86 is greater than thickness D88 plus 8-15 cm (e.g., 10-15 cm) on each side of crimping mechanism 24. Internal widths D84 and D88 are both typically 20-40 cm (e.g., 25-35 cm). For some applications, and as shown, bath 28 is generally circular, and diameters D84 and D88 are generally equal to each other (e.g., within 10 percent of each other, such as identical to each other).

[0148] Reference is made to FIGS. 2A-E, which are schematic illustrations showing crimping assembly 10 being used in combination with a delivery tool 42 to crimp a frame 56 of an implant 58, in accordance with some applications of the invention. As shown, implant 58 (FIG. 2B) may comprise a prosthetic heart valve, to be implanted at a native heart valve of a subject. Frame 56 is typically a shape-memory alloy such as nickel titanium (Nitinol). When an SMA device, in its original shape and size, is cooled to its martensitic state, and subsequently deformed, it will retain its deformed shape and size. Upon warming of the SMA device to its austenitic state, the device will return to its original shape and size.

[0149] As depicted in FIG. 2A, the co-linear axis 40 of port 38 and crimping aperture 26 enables advancement of a delivery tool 42 (FIG. 2B), which as depicted may include a shaft 44 and housing 46, through port 38, at least until housing 46 reaches aperture 26. Port 38 typically comprises an external portion 78 that is outside the bath. In certain embodiments, port 38 defines channel 50 having an internal diameter of 6-15 mm (e.g., 6-10 mm or 10-15 mm), and comprises a seal 48 that reversibly closes the channel (detailed in FIG. 2E) configured to maintain sealing as housing 46 and shaft 44 pass through channel 50 during the advancing.

[0150] The presence of a cooled liquid 60 within bath 28 maintains frame 56 at a cool temperature during crimping of the frame. Liquid 60 typically has a temperature of between −2 and 12 degrees C. (e.g., 4-10 degrees C.). In some applications of the invention, a portion 61 of liquid 60 may be frozen. For example, as well as putting liquid 60 into bath 28, frozen liquid (e.g., saline ice) 60a may also be added, in order to maintain liquid 60 at its cool temperature throughout the duration of the crimping of frame 56.

[0151] FIG. 2A shows assembly 10 prior to introduction of tool 42 or implant 58. FIG. 2A shows liquid 60 having been introduced into bath 28 prior to insertion of tool 42, but the liquid may alternatively be introduced after insertion of the tool. FIGS. 2B and 2C depict advancement of tool 42 into crimping aperture 26, such that frame 56 is disposed within the crimping aperture and immersed within cooled liquid 60. Frame 56 may be allowed to cool for a period of time while immersed in cooled liquid 60, prior to crimping. This period of time may typically last greater than 10 seconds (e.g., greater than 30 seconds) and/or less than 10 minutes (e.g., between 30 seconds and 10 minutes, such as 2-10 minutes). FIG. 2D shows contraction of crimping aperture 26 upon frame 56, crimping frame 56 while immersed in cooled liquid 60. Since implants comprising SMAs such as Nitinol are more easily deformed while in their martensitic state, it is therefore desirable to crimp such an implant while cooled below its transition temperature. Cooling of an SMA implant during crimping, which reduces a likelihood of damaging the implant or delivery tool during the crimping and loading processes, is achieved by disposition of crimping device 20 within a bath of the cooled liquid as shown in FIGS. 2C and 2D. FIG. 2E shows retraction of tool 42 through channel 50 of port 38, with implant 58 disposed within housing 46. Enlarged inset of FIG. 2E shows passage of tool shaft 44 through seal 48, while the seal prevents leakage of cooled liquid 60.

[0152] It is likely that some of liquid 60 becomes introduced into the subject during implantation of implant 58. Therefore, liquid 60 is typically suitable for introduction into the subject, e.g., being sterile, non-toxic, and/or isotonic. For example, liquid 60 may be sterile saline. It is to be noted that the crimping of implant 58 while immersed in cooled liquid 60, as described above, may reduce or obviate the need for subsequent flushing of air from the implant.

[0153] It is to be noted that the “heights” described herein (e.g., side-wall height D34, port-height D33, and aperture-height D35) are all heights above the same reference point, e.g., floor 30.

[0154] Reference is made to FIGS. 3, 4A-E, and 5, which are schematic illustrations showing the sealing of port 38 during advancing of housing 46 and shaft 44 of delivery tool 42 through the port. Some embodiments of the device include one or more washers 62, 66, and 68 fitted a first sealing nut 64 and a second sealing nut 70 (FIG. 3). Port 38 may be secured to port-defining side-wall 36 using screws (e.g., as shown), an adhesive, and/or any other suitable securing means.

[0155] Delivery tool housing 46 is advanced through a cap 74 (i.e., through an opening defined in the cap) (FIG. 4A). Subsequently, housing 46 is advanced through port 38 (FIG. 4B). Optionally, a plurality of plugs 72 are subsequently arranged into a ring that circumscribes shaft 44 and is disposed in an annular gap 76 between the shaft and external portion 78 of port 38 (FIGS. 4C-D).

[0156] Subsequently, cap 74 is fastened to external portion 78 of port 38 (FIG. 4E). For example, for some applications, an interior portion of cap 74 may be shaped to define threading, and cap 74 may be secured to port 38 by being screwed onto the port. Using cap 74 and plugs 72 in this manner allows port 38 to be configured to facilitate advancement of tool 42 through the port with relatively low resistance, and for sealing of the port 38 to be subsequently increased using the cap and plugs.

[0157] For some applications, the screwing of cap 74 onto external portion 78 pushes plugs 72 into gap 76.

[0158] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.