The present disclosure pertains to medical devices, and methods for manufacturing and using medical devices. More particularly, the disclosure is directed to implantable medical devices having a short linear actuation delivery mechanism.
A wide variety of medical devices have been developed for medical use, for example, for use in accessing body cavities and interacting with fluids and structures in body cavities. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. As an example, an assembly for delivering an implantable medical device includes an implantable medical device including an attachment feature and a delivery device that is adapted to releasably secure the implantable medical device, the delivery device including an attachment element adapted to create an interference fit with the attachment feature of the implantable medical device. The delivery device is adapted to enable a user to selectively disengage the interference fit between the attachment element of the delivery device and the attachment feature of the implantable medical device with a short linear motion when the delivery device is positioned proximate a delivery site for the implantable medical device.
Alternatively or additionally, the interference fit between the attachment element of the delivery device and the attachment feature of the implantable medical device may enable the implantable medical device to pivot relative to the delivery device before the interference fit is disengaged by the user.
Alternatively or additionally, the delivery device may include an attachment sheath and the attachment element may include a release cord adapted to extend through the attachment sheath and engage the attachment feature of the implantable medical device, the release cord including a distal region that is adapted to extend back into the attachment sheath.
Alternatively or additionally, the short linear motion may include moving the attachment sheath a distance of about ten millimeters or less in a proximal direction, thereby freeing the distal region of the release cord from the attachment sheath.
Alternatively or additionally, the release cord may be adapted to enable the release cord to be retracted proximally into the attachment sheath once the attachment sheath has been moved proximally.
Alternatively or additionally, the distal region may have an outer diameter that is greater than an outer diameter of a rest of the release cord.
Alternatively or additionally, the distal region may have an outer diameter that is equal to an outer diameter of a rest of the release cord.
Alternatively or additionally, the assembly may further include a moveable element having a first configuration in which the moveable element is adapted to hold the attachment element in the interference fit with the attachment feature and a second configuration in which the moveable element is adapted to release the attachment element from its interference fit with the attachment feature.
Alternatively or additionally, the one or more attachment features may include an attachment cavity formed within the implantable medical device, the one or more attachment elements may include an attachment member that fits within the attachment cavity, and the moveable element may be adapted to move within the attachment member between a release position in which the attachment member is released from an interference fit with the attachment cavity and a secure position in which the attachment member is held in an interference fit with the interference cavity.
Alternatively or additionally, the short linear motion may include moving the moveable element a distance of about ten millimeters or less in a proximal direction.
Alternatively or additionally, the moveable element may include a pin that is moveable within a lumen extending within the attachment member.
Alternatively or additionally, the one or more attachment features may include an attachment cavity formed within the implantable medical device, the attachment cavity including a toroidal spring, and the one or more attachment elements may include a rod having an annular groove adapted to accommodate the toroidal spring.
As another example, an assembly for delivering an implantable medical device includes an implantable medical device including an attachment feature and a delivery device adapted to releasably secure the implantable medical device. The delivery device includes an attachment sheath, the attachment sheath adapted to be linearly moveable a short distance. The delivery device includes a release cord adapted to extend through the attachment sheath and releasably engage the attachment feature, the release cord including a distal region that is adapted to extend back into the attachment sheath.
Alternatively or additionally, the attachment sheath may be adapted to be linearly moveable a short distance of about ten millimeters or less, thereby freeing the distal region of the release cord from the attachment sheath.
Alternatively or additionally, the release cord may be adapted to enable the release cord to be retracted proximally into the attachment sheath once the attachment sheath has been moved proximally.
Alternatively or additionally, the distal region may have an outer diameter that is greater than an outer diameter of a rest of the release cord.
Alternatively or additionally, the distal region may have an outer diameter that is equal to an outer diameter of a rest of the release cord.
As another example, an assembly for delivering an implantable medical device includes an implantable medical device having an attachment cavity formed within the implantable medical device. The assembly includes a delivery device adapted to releasably secure the implantable medical device. The delivery device includes an attachment member that is adapted to releasably fit within the attachment cavity, the attachment member including a lumen extending within the attachment member. The delivery device includes a moveable element slidingly disposed within the lumen, the moveable element moveable between a first configuration in which the moveable element is adapted to hold the attachment element in the interference fit with the attachment cavity and a second configuration in which the moveable element is adapted to release the attachment member from its interference fit with the attachment cavity.
Alternatively or additionally, the moveable element may be adapted to move axially within the lumen a distance of about ten millimeters or less in order to move between the first configuration and the second configuration.
Alternatively or additionally, the moveable object may include a pin.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
The implantable medical device 12 generically represents any of a variety of different implantable medical devices. In some cases, the implantable medical device 12 generically represents any of a variety of different implantable medical devices that can be delivered via a transcather delivery. One example of such an implantable medical device 12 is an LAAC (left atrial appendage closure) device. Another example of such an implantable medical device 12 is a cardiac implant such as a transcatheter valve implant or a valve repair device. Other implantable medical devices 12 are also contemplated.
The delivery device 14 is shown schematically, and only the portions of the delivery device 14 that are involved with releasably securing the implantable medical device 12 to the delivery device 14 are shown. The delivery device 14 includes an attachment sheath 18 that may be a metallic or polymeric cylinder, a coil or a hypotube, for example. The delivery device 14 also includes a release cord 20 that extends through the attachment sheath 18 in order to releasably engage the attachment feature 16 of the implantable medical device 12. The release cord 20 may be a thread, for example, with a heavier end on it. The release cord 20 may be a metallic wire, for example. In some cases, the release cord 20 includes a distal tip region 22 that has an outer diameter that is larger than an outer diameter of a rest of the release cord 20. The distal tip region 22 may be stiffer than a rest of the release cord 20, in order to make it more difficult for the distal tip region 22 to be removed from the attachment sheath 18.
Moving from
In some cases, a method of securing the implantable medical device 12 to the delivery device 14 may be seen in moving from
While not shown, the attachment sheath 18 itself either extends proximally to a point at which a user can manipulate a relative position of the attachment sheath 18, or the delivery device 14 includes one or more structures that operably engage the attachment sheath 18 and extend proximally such that a use can engage the one or more structures in order to move the attachment sheath 18 proximally, for example.
As a result of having been moved a short distance in the direction indicated by the arrow 24, it can be seen in
Progressing to
The delivery device 34 is shown schematically, and only the portions of the delivery device 34 that are involved with releasably securing the implantable medical device 32 to the delivery device 34 are shown. The delivery device 34 includes an attachment sheath 38 that may be a cylinder, a coil or a hypotube, for example. The delivery device 34 also includes a release cord 40 that extends through the attachment sheath 38 in order to releasably engage the attachment feature 36 of the implantable medical device 32. In some cases, the release cord 40 includes a distal tip region 42 that may get tucked into an interior of the attachment sheath 38. In some instances, the release cord 40 has a constant outer diameter, including the distal tip region 42.
Moving from
In some cases, a method of securing the implantable medical device 32 to the delivery device 34 may be seen in moving from
While not shown, the attachment sheath 38 itself either extends proximally to a point at which a user can manipulate a relative position of the attachment sheath 18, or the delivery device 34 includes one or more structures that operably engage the attachment sheath 38 and extend proximally such that a use can engage the one or more structures in order to move the attachment sheath 38 proximally, for example.
As a result of having been moved a short distance in the direction indicated by the arrow 44, it can be seen in
Progressing to
The delivery device 54 includes an outer housing 58 and a tether 60 that extends through the outer housing 58 and engages the attachment feature 56 of the implantable medical device 52. As better seen in
The attachment member 98 includes a lumen 102 that runs the length or at least substantially the length of the attachment member 98. The lumen 102 is adapted to accommodate a moveable element 104 that is slidingly disposed within the lumen 102. In some cases, the moveable element 104 is a pin, for example. When the moveable element 104 is extended within the lumen 102, as shown in
The attachment member 118 includes a lumen 122 that runs the length or at least substantially the length of the attachment member 118. The lumen 122 is adapted to accommodate a moveable element 124 that is slidingly disposed within the lumen 102. In some cases, the moveable element 124 is a pin, for example. When the moveable element 124 is extended within the lumen 122, as shown in
The attachment member 138 includes a lumen 142 that runs the length or at least substantially the length of the attachment member 138. The lumen 142 is adapted to accommodate a moveable element 144 that is slidingly disposed within the lumen 132. In some cases, the moveable element 144 is a pin, for example. When the moveable element 144 is extended within the lumen 142, as shown in
The delivery device 154 includes an elongate member 160 having a reduced diameter portion 162 that is adapted to fit into the attachment cavity 156 of the implantable medical device 152. The reduced diameter portion 162 includes an annular groove 164 that is adapted to releasably engage the toroidal spring 158. When the elongate member 160 is advanced towards the implantable medical device 152 such that the reduced diameter portion 162 enters the attachment cavity 156 of the implantable medical device 152, the toroidal spring 158 engages the annular groove 164, thereby securing the implantable medical device 152 relative to the delivery device 154.
In order to release the implantable medical device 152 from the delivery device 154, the elongate member 160 may be pulled in a direction indicated by an arrow 166. The interference fit between the toroidal spring 158 and the annular groove 164 may be overcome by applying an appropriate force.
As shown, the toroidal spring 158 is mounted within the attachment cavity 156 (within the implantable medical device 152) and the annular groove 164 is formed within the reduced diameter portion 162 of the elongate member 160 (part of the delivery device 154). In some cases, the toroidal spring 158 may instead be secured relative to the reduced diameter portion 162 of the elongate member 160, and the annular groove 164 may be disposed within the attachment cavity 156.
While not visible in this view, there is a threaded element underneath the slider 206, that is secured relative to the frame 202. Each threaded element is configured to threadedly engage the slider 206 such that rotation of the threaded element relative to the slider 206 causes the slider 206 to translate relative to the adjoining frame struts 204. Rotating the threaded element in a first direction may cause the slider 206 to move downward (in the illustrated orientation), thereby urging the adjoining frame struts 204 towards each other, thereby reducing an overall diameter of the frame 202. Rotating the threaded element in an opposing second direction may cause the slider 206 to move in an opposite direction, for example.
The adjustable endoluminal mitral valve ring implant 200 includes a number of anchor assemblies 208 that may be threaded into tissue proximate the mitral valve.
The body 210 includes a delivery aperture 218 that may be used to releasable secure the anchor assembly 208, and hence the adjustable endoluminal mitral valve ring implant 200, to a delivery device. It will be appreciated that the adjustable endoluminal mitral valve ring implant 200 may be delivered in a compressed configuration in which each of the sliders 206 are parallel or at least substantially parallel to each other, thereby providing a minimal diameter for delivery.
The devices described herein, as well as various components thereof, may be manufactured according to essentially any suitable manufacturing technique including molding, casting, mechanical working, and the like, or any other suitable technique. Furthermore, the various structures may include materials commonly associated with medical devices such as metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, and the like, or any other suitable material. These materials may include transparent or translucent materials to aid in visualization during the procedure. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; combinations thereof; and the like; or any other suitable material.
Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane, polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority of U.S. Provisional Application No. 63/315,612 filed Mar. 2, 2022, the entire disclosure of which is hereby incorporated by reference.
Number | Date | Country | |
---|---|---|---|
63315612 | Mar 2022 | US |