Powered Telescopic Medical Device Delivery System

Abstract

A system for delivering an implantable medical device includes a handle housing. An outer sheath is a connector fixed to the proximal end of the outer sheath, and the outer sheath is configured to cover at least a portion of the implantable medical device. An outer sheath drive assembly is operably connected to the outer sheath connector and is configured to translate the outer sheath relative to the handle housing. An actuation shaft connector is fixed to the proximal end of the actuation shaft. The actuation shaft drive assembly is operably connected to the actuation shaft connector and is configured to translate the actuation shaft relative to the handle housing and switch the implantable medical device between a first position and a second position, in which the implantable medical device radially expands relative to the first position.

Description

[0001] Cross-references to related literature

[0002] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 662,873, filed on April 26, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 662,873, filed on April 26, 2018, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present invention relates to medical device delivery systems. More particularly, the present invention relates to medical device delivery systems that include one or more motors that drive a telescoping assembly to deliver and deploy a medical device. Background Art

[0005] A variety of in vivo medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Of the known medical devices and methods, each device has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and using medical devices. Summary of the invention

[0006] The present invention provides designs, materials, manufacturing methods and use alternatives for medical devices. An example system for delivering an implantable medical device including a handle housing. An outer sheath coupler is fixed to the proximal end of the outer sheath, which is configured to cover at least a portion of the implantable medical device. The outer sheath drive assembly is operably connected to the outer sheath coupler and is configured to translate the outer sheath relative to the handle housing. An actuation shaft coupler is fixed to the proximal end of the actuation shaft, and the actuation shaft extends within the outer sheath. The actuation shaft drive assembly is operably connected to the actuation shaft coupler and is configured to translate the actuation shaft relative to the handle housing and switch the implantable medical device between a first position and a second position, in which the implantable medical device radially expands relative to the first position.

[0007] Alternatively or additionally, the outer sheath drive assembly may further include an outer sheath drive assembly motor having a motor coupling, an outer sheath drive assembly threaded rod operably coupled to the motor coupling such that actuation of the outer sheath drive assembly motor causes the outer sheath drive assembly threaded rod to rotate, and an outer sheath nut threadably engaged with the outer sheath drive assembly threaded rod and held against rotation such that rotation of the outer sheath drive assembly threaded rod causes the outer sheath nut to translate relative to the outer sheath drive assembly threaded rod. The outer sheath nut may be configured to engage the outer sheath coupler such that translation of the outer sheath nut relative to the outer sheath drive assembly threaded rod causes the outer sheath to translate relative to the handle housing.

[0008] Alternatively or additionally, the outer sheath drive assembly may further include a thrust bearing configured to fix the outer sheath drive assembly threaded rod at an end remote from the outer sheath drive assembly motor while allowing the outer sheath drive assembly threaded rod to rotate relative to the thrust bearing.

[0009] Alternatively or additionally, the outer jacket drive nut may be resisted from rotation by engagement with the outer jacket coupler.

[0010] Alternatively or additionally, the outer sheath drive assembly motor may include a direct drive motor.

[0011] Alternatively or additionally, the outer sheath drive assembly motor may further include a gearbox.

[0012] Alternatively or additionally, the actuation shaft drive assembly may include an actuation shaft drive assembly motor having a motor coupling, an actuation shaft drive assembly threaded rod operably connected to the motor coupling such that actuation of the actuation shaft drive assembly motor causes the actuation shaft drive assembly threaded rod to rotate, and an actuation shaft nut threadedly engaged with the actuation shaft drive assembly threaded rod and held against rotation such that rotation of the actuation shaft drive assembly threaded rod causes the outer sheath nut to translate relative to the actuation shaft drive assembly threaded rod. The actuation shaft nut may be configured to engage the actuation shaft coupling such that translation of the actuation shaft nut relative to the actuation shaft drive assembly threaded rod causes the outer sheath to translate relative to the handle housing.

[0013] Alternatively or additionally, the actuator shaft drive assembly may further include a thrust bearing configured to fix the actuator shaft drive assembly threaded rod at an end remote from the actuator shaft drive assembly motor while allowing the actuator shaft drive assembly threaded rod to rotate relative to the thrust bearing.

[0014] Alternatively or additionally, the actuation shaft drive nut may be held against rotation by engagement with the actuation shaft coupler.

[0015] Alternatively or additionally, the actuation shaft coupler may be disposed within the handle housing at a location proximal to the outer sheath coupler.

[0016] Alternatively or additionally, the system may further include a controller disposed within the handle housing and configured to control operation of the outer sheath drive assembly and / or the actuation shaft drive assembly.

[0017] Alternatively or additionally, the controller may be further configured to receive feedback from the outer sheath drive assembly and / or the actuation shaft drive assembly.

[0018] Alternatively or additionally, the system may further include a power source disposed within the handle and operably coupled to the controller.

[0019] Another example system for delivering an implantable medical device includes a handle housing and an outer sheath, the outer sheath being configured to cover at least a portion of the implantable medical device. An outer sheath coupler is fixed to the outer sheath so that translation of the outer sheath coupler relative to the handle housing causes translation of the outer sheath relative to the handle housing. An outer sheath nut is threadedly disposed on a first threaded rod and is operably coupled to the outer sheath coupler. An outer sheath drive motor is operably connected to the outer sheath nut so that driving of the outer sheath drive motor causes translation of the outer sheath nut relative to the first threaded rod, thereby translating the outer sheath coupler relative to the handle housing. An actuation shaft extends within the outer sheath and is operably coupled to a translation member fixed relative to the implantable medical device, so that translation of the actuation shaft causes translation of the translation member, which in turn causes the implantable medical device to switch from a delivery configuration to an expanded configuration. An actuation shaft coupler is fixed to the actuation shaft so that translation of the actuation shaft coupler relative to the handle housing causes translation of the actuation shaft relative to the handle housing. The actuation shaft nut is threadably disposed on the second threaded rod and is operably connected to the actuation shaft coupler. The actuation shaft drive motor is operably coupled to the actuation shaft nut so that actuation of the actuation shaft drive motor translates the actuation shaft nut relative to the second threaded rod, thereby translating the actuation shaft coupler relative to the handle housing.

[0020] Alternatively or additionally, the system may further include a first thrust bearing configured to fix the first threaded rod at an end remote from the outer sheath drive motor while allowing the first threaded rod to rotate relative to the first thrust bearing.

[0021] Alternatively or additionally, the system may further include a second thrust bearing configured to fix the second threaded nut at an end remote from the actuation shaft drive motor while allowing the second threaded rod to rotate relative to the second thrust bearing.

[0022] Alternatively or additionally, the overall length of the outer jacket nut may be from about 12 mm to about 150 mm.

[0023] Alternatively or additionally, the overall length of the actuation shaft nut may be from about 12 mm to about 150 mm.

[0024] Alternatively or additionally, the system may further include a controller disposed within the handle housing and configured to control operation of the outer sheath drive motor and / or the actuation shaft drive motor.

[0025] Another example system for delivering an implantable medical device includes a handle housing. An actuation shaft is operably coupled to a translation member fixed relative to the implantable medical device, such that translation of the actuation shaft causes translation of the translation member, and translation of the translation member in turn causes the implantable medical device to switch from a delivery configuration to a deployment configuration. An actuation shaft coupler is fixed to the actuation shaft, such that translation of the actuation shaft coupler relative to the handle housing causes translation of the actuation shaft relative to the handle housing. An actuation shaft nut is threadedly disposed on a threaded rod and is operably coupled to the actuation shaft coupler. An actuation shaft drive motor is operably coupled to the actuation shaft nut, such that actuation of the actuation shaft drive motor causes translation of the actuation shaft nut relative to a second threaded rod, thereby translating the actuation shaft coupler relative to the handle housing.

[0026] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention may be more fully understood upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which:

[0028] Figure 1 is a side view of an exemplary medical device system;

[0029] Figure 2 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0030] Figure 3 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0031] Figure 4 is a partial cross-sectional view of an exemplary medical device delivery system;

[0032] Figure 5 is an exploded view of an exemplary medical device delivery system;

[0033] Figure 6 is a view of a portion of an exemplary medical device delivery system;

[0034] Figure 7 is a view of a portion of an exemplary medical device delivery system;

[0035] Figure 8 is a view of a portion of an exemplary medical device delivery system;

[0036] Fig. 9 is a diagram of a portion of an exemplary medical device delivery system; and

[0037] Fig.10 is a schematic block diagram of an exemplary medical device delivery system;

[0038] Although the content of the present invention can be subjected to various modifications and alternative forms, its specific content has been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternative forms that belong to the spirit and scope of the present invention. DETAILED DESCRIPTION

[0039] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0040] All numerical values ​​herein are assumed to be modified by the term "about", whether or not explicitly stated. The term "about", in the context of numerical values, generally refers to a range of numbers that one skilled in the art considers to be equivalent to the stated numerical value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant number.

[0041] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0042] 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. The term "or" as used in this specification and the appended claims is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0043] It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include a particular characteristic, structure, and / or feature. However, such a description does not necessarily mean that all embodiments include the particular characteristic, structure, and / or feature. Additionally, when particular characteristics, structures, and / or features are described in conjunction with one embodiment, it should be understood that, unless expressly provided otherwise, these characteristics, structures, and / or features may also be used in conjunction with other embodiments, whether or not expressly described.

[0044] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily drawn to scale, depict exemplary embodiments and are not intended to limit the scope of the present disclosure.

[0045] Diseases and / or medical conditions that affect the cardiovascular system are common throughout the world. Traditionally, treatments for the cardiovascular system are often performed by directly accessing the affected part of the body. For example, blockages in one or more coronary arteries have traditionally been treated using coronary artery bypass surgery. As can be readily appreciated, such treatments are quite invasive for the patient and require extensive recovery time and / or treatment. Recently, less invasive treatments have been developed. For example, treatments (e.g., angioplasty) have been developed that allow access and treatment of blocked coronary arteries via percutaneous catheters. Such treatments have been widely accepted by patients and clinicians.

[0046] Some relatively common medical conditions may include or be caused by inefficiency, ineffectiveness, or complete failure of one or more valves within the heart. For example, failure of the aortic valve or mitral valve can have serious effects on a person and, if not properly treated, can lead to serious illness and / or death. Treatment of heart valve defects presents other challenges because treatment typically requires repairing or completely replacing the defective valve. Such treatment methods can be very traumatic to the patient. The medical device disclosed herein can be used to deliver a medical device to a portion of the cardiovascular system to diagnose, treat, and / or repair the system. At least some of the medical devices disclosed herein can be used to deliver and implant replacement heart valves (e.g., replacement aortic valves, replacement mitral valves, etc.). In addition, the devices disclosed herein can deliver replacement heart valves percutaneously, and therefore, can be much less invasive to the patient. The devices disclosed herein can also provide some additional desired features and advantages, as described in detail below.

[0047] The figures show selected components and / or arrangements of a medical device system 10, such as in Figure 1 1 and 1 . It should be noted that in any given figure, some features of the medical device system 10 may not be shown or may be shown schematically for the sake of simplicity. Additional details regarding some components of the medical device system 10 may be shown in more detail in other figures. The medical device system 10 can be used to deliver a variety of medical devices to many locations in the body and / or deploy at many locations in the body. In at least some embodiments, the medical device system 10 may include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used to percutaneously deliver a medical implant 16 (in Figure 1 ), such as a replacement / prosthetic heart valve. However, this is not intended to be limiting, as the medical device system 10 may also be used for other interventions, including valve repair, valvuloplasty, delivery of implantable medical devices (e.g., such as stents, grafts, etc.), or other similar interventions.

[0048] The medical device system 10 can be generally described as a catheter system, which includes an outer sheath 12, an inner catheter 14 that extends at least partially through the lumen of the outer sheath 12, and a medical implant 16 (e.g., a replacement heart valve implant), which can be connected to the inner catheter 14 and located within the lumen of the outer sheath 12 during delivery of the medical implant 16. In some embodiments, a medical device handle 17 can be located at the proximal end of the outer sheath 12 and / or the inner catheter 14, and can include one or more actuation mechanisms associated therewith. In other words, one or more tubular members (e.g., outer sheath 12, inner catheter 14, etc.) can extend distally from the medical device handle 17. In general, the medical device handle 17 can be designed to manipulate the position of the outer sheath 12 relative to the inner catheter 14 and / or to assist in the deployment of the medical implant 16.

[0049] It is to be understood that the medical device system 10 can be designed such that the handle 17 can manually and / or electrically drive one or more components of the medical device system 10 (via one or more motors positioned inside and / or outside the handle 17). In other words, it is contemplated that in some cases, the clinician can manually manipulate the handle (e.g., via linear or rotary actuation) to deploy the medical implant 16. However, it is also contemplated that in other instances, the clinician can engage one or more selector switches (e.g., buttons) that can actuate one or more electric motors to actuate and deploy the medical implant 16.

[0050] In use, the medical device system 10 can be percutaneously advanced through a blood vessel to a location adjacent to an area of ​​interest and / or treatment location. For example, in some embodiments, the medical device system 10 can be advanced through a blood vessel to a location adjacent to a defective native valve (e.g., aortic valve, mitral valve, etc.). Alternative methods of treating defective aortic valves and / or other heart valves with the medical device system 10 are also contemplated. During delivery, for example, Figure 1 14, the medical implant 16 can be generally arranged in a slender and low-profile "delivery" configuration within the lumen and / or the distal end of the outer sheath 12. After placement, the outer sheath 12 can be retracted relative to the medical implant 16 and / or the inner catheter 14 to expose the medical implant 16. In some cases, the medical implant 16 can be self-expanding, thereby exposing the medical implant 16 to deploy the medical implant 16. Alternatively, the medical implant 16 can be expanded / deployed using the medical device handle 17 so as to convert the medical implant 16 into a substantially shortened and larger profile "deployed" configuration suitable for implantation in the body. When the medical implant 16 is properly deployed in the body, the medical device system 10 can be disconnected, separated and / or released from the medical implant 16, and the medical device system 10 can be removed from the blood vessel, leaving the medical implant 16 in place in the "released" configuration.

[0051] It is understood that during delivery and / or deployment of an implantable medical device (e.g., medical implant 16), some portions of a medical device system (e.g., medical device system 10) may need to be advanced through a tortuous and / or narrow cavity. Therefore, it may be necessary to utilize components and design a medical delivery system (e.g., such as medical device system 10 and / or other medical devices) to reduce the profile of the medical device portion while maintaining sufficient strength (compression, torsion, etc.) and flexibility of the system as a whole.

[0052] Figure 2 The medical device system 10 is shown in a partially deployed configuration. Figure 2 As shown, the outer sheath 12 of the medical device system 10 has been retracted in the proximal direction to a proximal position of the medical implant 16. In other words, the outer sheath 12 has been retracted (e.g., pulled back) in the proximal direction so that it exposes the medical device implant 16 from a compact, low-profile delivery position to a partially deployed position.

[0053] In at least some examples contemplated herein, the medical device implant 16 can be designed to self-expand once released from under the outer sheath 12. Figure 2 As shown, the medical device system 10 can be designed so that the implant 16 can be restricted from fully expanding in the radial direction. For example, Figure 2 The medical device implant 16 is shown having a partially deployed position indicated as length "L1".

[0054] Figure 2 As further shown, in some examples, the implant 16 can include one or more support members 22 coupled to the proximal end 18 of the implant 16. In addition, Figure 2 As shown, in some examples, the implant 16 can include one or more translating members 24 coupled to the distal end 20 of the implant 16. Additionally, in some examples (e.g. Figure 2 ), the translating member 24 and the support member 22 can work together to maintain the implant in a partially deployed position after the outer sheath 12 is retracted to expose the implant 16. For example, Figure 2 It is shown that the support members 22 can be designed so that the distal end of each support member 22 can be coupled to the proximal end of the implant 16, and the proximal end of each support member 22 can be coupled to the distal end of the inner catheter 14. For example, Figure 2 The proximal end of the support member 22 is shown to be attached to a closure fitting 29 that is rigidly fixed to the distal end of the inner catheter 14. It can be further understood that in some cases, the support member 22 can be designed to limit the proximal movement of the proximal end 18 of the implant 16 relative to the distal end of the inner catheter 14.

[0055] Furthermore, the translating member 24 can be designed to translate in a distal-to-proximal direction such that translation of the translating member (eg, via manipulation by an operator at the handle) can “pull” the distal end 20 of the implant proximal to the proximal end 18 of the implant 16 .

[0056] For example, Figure 3 The distal-to-proximal translation of the translating member 24 is shown. It will be appreciated that if the support member 22 limits the proximal movement of the proximal end 18 of the implant 16 while the translating member 24 translates proximally, the implant 16 both contracts (along the longitudinal axis of the implant 16) and expands radially outward. By comparison Figure 2 The shape and position of the implant 16 in Figure 3 1. The shape and position of the implant 16 in FIG. 1, it can be seen that the implant 16 is retracted and radially expanded. Figure 3 The position of the implant 16 shown in FIG. 1 may be described as the fully deployed position of the implant 16 (relative to FIG. Figure 2 ). Further, Figure 3 The length of the fully deployed implant 16 is described as "L2", whereby the distance L2 is less than Figure 2 The distance L1 shown in .

[0057] Furthermore, it will be appreciated that the translating member 24 can be designed to be extendable in a proximal-to-distal direction to elongate (e.g., lengthen) the implant 16 (along its longitudinal axis). In other words, the implant 16 can be configured to be extendable in a partially deployed position (e.g., distally or proximally) by translation of the translating member 24 along the longitudinal axis. Figure 2 ) and the fully extended position (as Figure 3 ) because the support member 22 limits the movement of the proximal end 18 of the implant 16.

[0058] It should be noted that the above description and illustration of the arrangement, attachment features, and operation of the support member 22 and the translation member 24 as they engage and function relative to the implant 16 are illustrative. It is understood that the design (e.g., arrangement, attachment features, operation, etc.) of the support member 22 and the translation member 24 as they relate to and function relative to the implant 16 may vary. For example, the translation member 24 and the support member 22 may be designed, arranged, and operated in a variety of ways to achieve the partially and fully deployed configurations of the implant 16 described herein.

[0059] In some embodiments, an operator may be able to operate the translating member 24 via the handle 17. For example, the handle 17 may include an actuation member intended to control the translation of the translating member 24. Figure 2 As shown, the handle member 17 can be coupled to the translation member 24 via the actuation shaft 30 and the coupling member 28. In addition, Figure 2 It is also shown that the distal end of the actuation shaft 30 can be coupled to the proximal end of the coupling member 28. Further, although Figure 2 Not shown, but understood, the actuation shaft 30 may extend throughout the entire length of the inner catheter 14 from the coupling member 28 to the handle member 17 .

[0060] For the purposes of this discussion, the inner catheter 14 may also be referred to as an inner member or liner 14. The liner 14 may include many different features shown in the figures described herein. For example, the liner 14 may include a cavity 25. In addition, the translation member 24, the coupler 28, the actuation shaft 30, the tubular guidewire member 34 (described below), and the grouping coil 32 (described below) may be disposed within the cavity 25. These are just examples. The form of the inner liner 14 can be different. For example, the inner liner 14 may include a single cavity, multiple cavities, or no cavity.

[0061] As mentioned above, Figure 2 and Figure 3 The translating member 24 is shown translating in the distal to proximal direction (which, as described above, shortens and radially expands the implant 16). Figure 3 It is further illustrated that translation of the translating member 24 in the distal-to-proximal direction is accomplished by translation of the drive shaft 30 and the coupling member 28 within the lumen 25 of the inner catheter 14. For example, when the actuation shaft 30 is retracted (e.g., approximately pulled within the lumen 25 of the inner catheter 14), it proximally retracts the coupling member 28, which in turn retracts the translating member 24 in the proximal direction.

[0062] In some cases, it may be desirable to maintain the translating member 24 in a substantially linear configuration as the translating member 24 is translated within the lumen 25 of the inner catheter 14. Thus, in some examples, the medical device system 10 may include components designed to limit and / or prevent the translating members 24 from twisting relative to one another within the lumen 25 of the inner catheter 14. For example, Figure 2 and Figure 3 Grouped coils 32 are shown wound around the translating member 24 so that as the translating member 24 translates through the lumen 25 of the inner catheter 14, the grouped coils 32 maintain the translating member 24 in a substantially liner configuration (and thereby limit and / or prevent twisting of the translating member 24 within the lumen 25).

[0063] Figure 2 and Figure 3 To further illustrate, the proximal end of the grouped coil 32 may be positioned adjacent to the distal end of the coupling member 28, and the distal end of the grouped coil 32 may be positioned adjacent to the distal end of the inner catheter 14. Specifically, the distal end of the grouped coil 32 may be prevented from extending beyond the distal end of the inner catheter 14 by the closure fitting 29. In other words, the distal end of the grouped coil 32 may contact the closure fitting 29.

[0064] It can be further understood that the grouped coils 32 can be positioned within the lumen 25 of the inner catheter 14 such that the grouped coils 32 can be extended and shortened within the lumen 25 of the inner catheter 14 (e.g., the length of the grouped coils can be adjusted). For example, when the coupling member 28 is translated in the proximal direction (with the Figure 2 In comparison, Figure 3 ), the grouping coils 32 may be elongated while continuing to group and / or contain the translating members 24 in a generally linear configuration.

[0065] Figure 2 and Figure 3 It is further illustrated that the medical device 10 may include a tubular guidewire member 34 extending within the lumen 25 of the inner catheter 14. The tubular guidewire member 34 may include a lumen that allows a guidewire to extend and translate therefrom. In other words, the medical device system 10 may be advanced to a target site in the body via a guidewire extending within the lumen of the tubular guidewire member 34. Further, the tubular guidewire member 34 may extend from the handle member 17, through the lumen 25 of the inner member 14, through the implant 16, and terminate at the nose cone 36.

[0066] It will be appreciated from the above discussion that the outer member 12, the inner shaft 14, the actuation shaft 30 (which is coupled to the translating member 24), and the tubular guidewire member 34 can all extend from a position adjacent to the medical implant 16 to a position where they enter the handle member 17. For example, Figure 4 Shown are outer sheath 12, inner shaft 14, actuation shaft 30 (which is connected to translation member 24), and tubular guidewire member 34, which may extend from an example medical implant 16 (which may be similar in form and function to the medical implants described above) and into distal end 45 of handle member 17.

[0067] Figure 5 The medical device system 10 is illustrated showing the housing portion 50 removed to expose features of the handle 17 . Figure 6 Further shown is a coaxial and telescopic arrangement between the guidewire member 34, the actuation shaft 30, the inner catheter 14, and the outer sheath 12. Within the handle 17, the outer sheath coupler 52 is operably fixed to the proximal end 54 of the outer sheath 12, so that when the outer sheath coupler 52 moves relative to the housing portion 50, the outer sheath 12 moves relative to the handle 17. In some cases, the outer sheath coupler 52 can include a Luer lock flush port 53, and the housing portion 50 can include an elongated slot 51 to accommodate the movement of the outer sheath coupler 52 relative to the handle 17 (and thus the movement of the Luer lock flush port 53).

[0068] Coupler 56 can be fixed to the proximal end 58 of inner catheter 14. In some cases, coupler 56 can be fixed within handle 17. Actuation shaft coupler 60 can be operably coupled to the proximal end 62 of actuation shaft 30 so that when actuation shaft coupler 60 moves relative to handle 17, actuation shaft 30 moves relative to handle 17. Coupler 64 can be fixed to the proximal end 66 of guidewire member 34. In some cases, coupler 64 can be fixed in place within handle 17.

[0069] In some cases, such as Figure 6 17 , the outer sheath coupler 52 may include an annular groove 70 and the actuation shaft coupler 60 may include an annular groove 72. In some cases, as will be discussed, the annular groove 70 and the annular groove 72 may allow the outer sheath coupler 52 and the actuation shaft coupler 60 to be coupled to an outer sheath drive assembly 74 and an actuation shaft drive assembly 76, respectively. In some cases, as will be understood, the outer sheath drive assembly 74 may be configured to translate the outer sheath coupler 52, and thus the outer sheath 12, relative to the handle 17. The actuation shaft drive assembly 76 may be configured to translate the actuation shaft coupler 60, and thereby the actuation shaft 30, relative to the handle 17. Figure 7 The outer sheath drive assembly 74 is better shown in FIG. Figure 8 The actuator shaft drive assembly 76 is better shown in FIG.

[0070] like Figure 7 As shown, the outer sheath drive assembly 74 includes an outer sheath drive assembly motor 80. In some cases, the outer sheath drive assembly motor 80 includes a motor 82 and a gear box 84, although in some cases, the motor 82 can be a direct drive motor without a separate gear box. In some cases, the outer sheath drive assembly motor 80 includes a motor coupling 86, through which the outer sheath drive assembly motor 80 can be operably connected to the outer sheath drive assembly threaded rod 88. In some cases, the outer sheath drive assembly threaded rod 88 can replace the component formed as the output shaft of the motor 82. When the outer sheath drive assembly motor 80 is driven, the outer sheath drive assembly threaded rod 88 is driven to rotate. The thrust bearing 90 receives the distal end 92 of the outer sheath drive assembly threaded rod 88 and is configured to allow the outer sheath drive assembly threaded rod 88 to rotate relative to the thrust bearing 90. The outer sheath nut 94 is threadedly mounted on the outer sheath drive assembly threaded rod 88 and is held against rotation by engagement with the outer sheath coupler 52. As the outer sheath drive assembly threaded rod 88 rotates, the outer sheath nut 94 translates relative to the outer sheath drive assembly threaded rod 88 and, therefore, the outer sheath 12 translates relative to the handle 17 .

[0071] like Figure 8As shown, the actuating shaft drive assembly 76 includes an actuating shaft drive assembly motor 100. In some cases, the actuating shaft drive assembly motor 100 includes a motor 102 and a gear box 104, although in some cases, the motor 102 can be a direct drive motor without a separate gear box. In some cases, the actuating shaft drive assembly motor 100 includes a motor coupling 106, through which the actuating shaft drive assembly motor 100 can be operably connected to the actuating shaft drive assembly threaded rod 108. In some cases, the actuating shaft drive assembly threaded rod 108 can replace the component formed as the output shaft of the motor 102. When the actuating shaft drive assembly motor 100 is actuated, the actuating shaft drive assembly threaded rod 108 is driven to rotate. The thrust bearing 110 receives the distal end 112 of the actuating shaft drive assembly threaded rod 108 and is configured to allow the actuating shaft drive assembly threaded rod 108 to rotate relative to the thrust bearing 110. The actuating shaft nut 114 is threadedly disposed on the actuating shaft drive assembly threaded rod 108 and is held against rotation by engagement with the actuating shaft coupler 60. When the actuating shaft drive assembly threaded rod 108 rotates, the actuating shaft nut 114 translates relative to the actuating shaft drive assembly threaded rod 108, and thus, the actuating shaft 30 translates relative to the handle 17.

[0072] Fig. 9 is an enlarged view of the actuation shaft nut 114. In some cases, the outer sheath nut 84 can have a similar structure and construction. In some cases, the outer sheath nut 84 can have slight differences to accommodate structural changes in the outer sheath coupler 52. The actuation shaft nut 114 includes a body 120 that defines a bore 122 extending through the body 120 from a first end 124 to a second end 126. In some cases, the threaded portion of the bore 122 may not extend from the first end 124 to the second end 126, but may extend only over a portion of the length of the bore 122. For example, in some cases, approximately half of the length of the bore 122 may be threaded. For example, the threaded portion may be centered within the bore 122, but this is not required.

[0073] In some cases, the body 122 can have an overall length L3 that is greater than the corresponding diameter D1 of the body 122. In some cases, the body 122 can have a length L3 in the range of about 12 millimeters (mm) to about 150 mm and a diameter D1 in the range of about 3 mm to about 35 mm. In some cases, having a length L3 that is much greater than the diameter D1 allows the actuation shaft nut 114 to better handle the torque applied to the actuation shaft nut 114. The actuation shaft nut 114 includes a coupler engagement portion 130 that is configured to engage with the actuation shaft coupler 60. In some cases, the coupler engagement portion 130 can include an annular portion 132 that is sized to engage with an annular groove 72 formed in the actuation shaft coupler 60. In some cases, the actuation shaft nut 114 can include slots 140 and 142 on both sides of the body 122. In some cases, the slots 140 and 142 can be used to help position the actuation shaft nut 114 in the handle 17. In some cases, the elongated slots 140 and 142 can run along corresponding tracks (not shown) formed in the handle 17. Although two elongated slots 140 and 142 are shown, in some cases, there can be only one elongated slot, or there can be more than three elongated slots. In some cases, the elongated slots 140 and 142 running along corresponding guides can also help limit the torque applied to the actuation shaft nut 114.

[0074] Fig.10 A system 150 is shown that can be considered representative of the medical device system 10 and can be embodied, for example, within the handle 17. The system 150 has an outer sheath drive assembly 152 including an outer sheath drive motor 154. The system 150 has an actuation shaft drive assembly 156 including an actuation shaft drive motor 158. It can be appreciated that the outer sheath drive assembly 152 can be considered representative of the medical device system 10. Figure 7 The outer sheath drive assembly 74 is shown in FIG. 1 , while the actuating shaft drive assembly 156 may be considered to represent Figure 8 The actuator shaft drive assembly 76 is shown in FIG.

[0075] Control board 160 includes controller 162. In some cases, controller 162 can be configured to control the operation of outer sheath drive assembly 152 (including outer sheath drive motor 154) and / or actuation shaft drive assembly 156 (including actuation shaft drive motor 158). In some cases, controller 162 can receive feedback from outer sheath drive assembly 152 and / or actuation shaft drive assembly 156 and can use this feedback to control outer sheath drive assembly 152 and / or actuation shaft drive assembly 156. In some cases, power source 164 can be disposed within handle 17 and can be operably coupled to controller 162.

[0076] Materials that can be used for the various components of the medical devices and / or systems 10 disclosed herein may include those materials typically associated with medical devices. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other components of the medical devices and / or systems 10 disclosed herein, including the various shafts, bushings, components described with respect thereto.

[0077] The medical device 10 can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials or combinations of materials. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont), ), ether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), ether esters (e.g., available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer Or can be purchased from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, can be ), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), high-density polyethylene (HDPE), polyester, Marex high-density polyethylene, Marex low-density polyethylene, linear low-density polyethylene (e.g. ), ultra-high molecular weight (UHMW) polyethylene, polypropylene, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., ), polysulfone, nylon, nylon 12 (such as purchased from EMS American Grilon ), perfluoropropyl vinyl ether (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP).

[0078] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, and 316LV stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625 such as 625, UNS: N06022 such as UNS:N10276 other Alloys, etc.), nickel-copper alloys (such as UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as etc.), nickel-molybdenum alloys (such as UNS: N10665, such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0079] In at least some embodiments, part or all of the medical device 10 may also incorporate, be made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluorescent screen or another imaging technique during medical surgery. This relatively bright image helps the user of the medical device 10 determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be added to the design of the medical device 10 to achieve the same effect.

[0080] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device 10. For example, the medical device 10 may include materials that do not substantially distort images and produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. The medical device 10 may also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, etc.), etc.), Nitinol etc. and others.

[0081] It should be understood that the present invention is illustrative in many respects. Changes may be made in detail, particularly in shape, size, and arrangement of steps without exceeding the scope of the present invention. This may include, within appropriate limits, using any feature of one embodiment in other embodiments. Of course, the scope of the present invention is defined in the language expressed in the appended claims.

Claims

1. A system for delivering an implantable medical device, comprising: Handle housing; an outer sheath coupler secured to a proximal end of an outer sheath configured to cover at least a portion of the implantable medical device; an outer shield drive assembly operably connected to the outer shield coupler, the outer shield drive assembly configured to translate the outer shield relative to the handle housing; The outer sheath drive assembly comprises: an outer sheath drive assembly motor having a motor coupling; an outer sheath drive assembly threaded rod operably coupled to the motor coupling such that actuation of the outer sheath drive assembly motor causes rotation of the outer sheath drive assembly threaded rod; a thrust bearing configured to secure the outer sheath drive assembly threaded rod at an end remote from the outer sheath drive assembly motor while allowing the outer sheath drive assembly threaded rod to rotate relative to the thrust bearing; an actuation shaft coupler secured to a proximal end of an actuation shaft extending within the outer sheath; as well as An actuation shaft drive assembly is operably connected to the actuation shaft coupler, and the actuation shaft drive assembly is configured to translate the actuation shaft relative to the handle housing and switch the implantable medical device between a first position and a second position, in which the implantable medical device radially expands relative to the first position.

2. The system of claim 1, wherein the outer sheath drive assembly comprises: an outer sheath nut threadably engaged with the outer sheath drive assembly threaded rod and held against rotation such that rotation of the outer sheath drive assembly threaded rod causes translation of the outer sheath nut relative to the outer sheath drive assembly threaded rod; Wherein the outer sheath nut is configured to engage the outer sheath coupler such that translation of the outer sheath nut relative to the outer sheath drive assembly threaded rod causes translation of the outer sheath relative to the handle housing.

3. The system of claim 1, wherein the outer sheath drive assembly motor comprises a direct drive motor.

4. The system of claim 1, wherein the outer sheath drive assembly motor further comprises a gearbox.

5. The system of claim 1, wherein the actuator shaft drive assembly comprises: an actuating shaft drive assembly motor having a motor coupling; an actuation shaft drive assembly threaded rod operably coupled to the motor coupling such that actuation of the actuation shaft drive assembly motor causes rotation of the actuation shaft drive assembly threaded rod; and an actuation shaft nut threadedly engaged with the actuation shaft drive assembly threaded rod and held against rotation such that rotation of the actuation shaft drive assembly threaded rod causes the outer sheath nut of the outer sheath drive assembly to translate relative to the actuation shaft drive assembly threaded rod; The actuation shaft nut is configured to engage the actuation shaft coupler such that translation of the actuation shaft nut relative to the actuation shaft drive assembly threaded rod causes translation of the outer sheath relative to the handle housing.

6. The system of claim 5, wherein the actuator shaft drive assembly further comprises a thrust bearing configured to fix the actuator shaft drive assembly threaded rod at an end away from the actuator shaft drive assembly motor while allowing the actuator shaft drive assembly threaded rod to rotate relative to the thrust bearing.

7. The system of claim 5, wherein the actuation shaft coupler is disposed within the handle housing at a location proximal to the outer sheath coupler.

8. The system of claim 1, further comprising a controller disposed within the handle housing and configured to control operation of the outer sheath drive assembly and / or the actuator shaft drive assembly.

9. The system of claim 8, wherein the controller is further configured to receive feedback from the outer sheath drive assembly and / or the actuation shaft drive assembly.

10. A system for delivering an implantable medical device, comprising: Handle housing; an outer sheath configured to cover at least a portion of the implantable medical device; an outer shield coupler secured to the outer shield such that translation of the outer shield coupler relative to the handle housing causes translation of the outer shield relative to the handle housing; an outer jacket nut threadably disposed on the first threaded rod and operably coupled to the outer jacket coupler; an outer shield drive motor operably coupled to the outer shield nut such that actuation of the outer shield drive motor causes the outer shield nut to translate relative to the first threaded rod, thereby causing the outer shield coupler to translate relative to the handle housing; an actuation shaft extending within the outer sheath and operably coupled to a translating member fixed relative to the implantable medical device such that translation of the actuation shaft causes translation of the translating member, thereby causing the implantable medical device to switch from a delivery configuration to a deployed configuration; an actuation shaft coupler secured to the actuation shaft such that translation of the actuation shaft coupler relative to the handle housing causes translation of the actuation shaft relative to the handle housing; an actuation shaft nut threadably disposed on the second threaded rod and operably coupled to the actuation shaft coupler; an actuation shaft drive motor operably coupled to the actuation shaft nut such that actuation of the actuation shaft drive motor causes the actuation shaft nut to translate relative to the second threaded rod, thereby causing the actuation shaft coupler to translate relative to the handle housing; A first thrust bearing is configured to fix the first threaded rod at an end away from the outer sheath driving motor while allowing the first threaded rod to rotate relative to the first thrust bearing.

11. The system of claim 10, further comprising a second thrust bearing configured to secure a second threaded nut at an end distal from the actuation shaft drive motor while allowing the second threaded rod to rotate relative to the second thrust bearing.

12. The system of claim 10, further comprising a controller disposed within the handle housing and configured to control operation of the outer sheath drive motor and / or the actuator shaft drive motor.

13. A system for delivering an implantable medical device, comprising: Handle housing; an actuation shaft operably coupled to a translating member that is fixed relative to the implantable medical device such that translation of the actuation shaft causes translation of the translating member, which in turn causes the implantable medical device to switch from a delivery configuration to a deployed configuration; an actuation shaft coupler secured to the actuation shaft such that translation of the actuation shaft coupler relative to the handle housing causes translation of the actuation shaft relative to the handle housing; an actuation shaft nut threadably disposed on the threaded rod and operably coupled to the actuation shaft coupler; an actuation shaft drive motor operably coupled to the actuation shaft nut such that actuation of the actuation shaft drive motor causes translation of the actuation shaft nut relative to the second threaded rod, thereby causing translation of the actuation shaft coupler relative to the handle housing; and A thrust bearing is configured to secure the threaded rod at an end remote from the actuation shaft drive motor while allowing the threaded rod to rotate relative to the thrust bearing.

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