Medical device delivery system including a resistance member

Example medical device delivery systems are disclosed. An example delivery system for an implantable medical device includes an outer shaft having a distal end region, a proximal end region and a lumen extending therebetween. The delivery system also includes a handle coupled to the proximal end region of the outer shaft, wherein the handle includes a first actuator, a carriage and a housing. The delivery system also includes a selector coupled to the handle and a resistance member disposed along a portion of the selector. Further, the selector is configured to shift between a first configuration and a deployment configuration. Additionally, the carriage is free from the resistance member in the first configuration and the resistance member contacts the carriage in the deployment configuration.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical device delivery systems including a translating engagement member.

BACKGROUND

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example delivery system for an implantable medical device includes an outer shaft having a distal end region, a proximal end region and a lumen extending therebetween. The delivery system also includes a handle coupled to the proximal end region of the outer shaft, wherein the handle includes a first actuator, a carriage and a housing. The delivery system also includes a selector which may be in the form of a cap coupled to the handle and a resistance member disposed along a portion of the selector. Further, the selector is configured to shift between a first configuration and deployment configuration. Additionally, the carriage is free from the resistance member in the first configuration and the resistance member contacts the carriage in the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the resistance member contacts an inner surface along a distal end region of the housing in the first configuration.

Alternatively or additionally to any of the embodiments above, wherein the resistance member contacts an inner surface along a distal end region of the carriage in the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the carriage is configured to rotate, and wherein the resistance member is configured to increase a rotational force required to rotate the carriage in the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the cap includes a circumferential groove positioned along a proximal end region thereof, wherein at least a portion of the resistance member is positioned along the groove.

Alternatively or additionally to any of the embodiments above, further comprising an implant loading device positioned adjacent the distal end region of the outer shaft.

Alternatively or additionally to any of the embodiments above, wherein the cap includes an inner surface, an outer surface and a wall extending therebetween, and wherein the cap includes an aperture extending through a wall of the cap.

Alternatively or additionally to any of the embodiments above, wherein the aperture includes a length, and wherein the length of the aperture corresponds to a distance along which the cap shifts between the first configuration and the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the aperture is aligned along a longitudinal axis of the cap.

Alternatively or additionally to any of the embodiments above, wherein the aperture is offset from a longitudinal axis of the cap.

Alternatively or additionally to any of the embodiments above, wherein rotating the cap shifts it between the first configuration and the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the cap includes a circumferential lip extending circumferentially along a distal end region thereof.

Alternatively or additionally to any of the embodiments above, wherein the lip extends radially away from an outer surface of the cap.

Alternatively or additionally to any of the embodiments above, wherein the resistance member is configured to exert a radially outward force on an inner surface of the carriage in the deployment configuration.

Another example delivery system for an implantable medical device includes:

an outer shaft having a distal end region, a proximal end region and a lumen extending therebetween;

a handle coupled to the proximal end region of the outer shaft, wherein the handle includes a first actuator, a carriage and a housing;

a cap coupled to the handle; and

a resistance member disposed along a portion of the cap;

wherein the cap is configured to shift between a first configuration and a deployment configuration, and wherein the carriage is free from the resistance member in the first configuration and wherein the resistance member exerts a radially outward force upon the carriage in the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the resistance member contacts an inner surface along a distal end region of the housing in the first configuration.

Alternatively or additionally to any of the embodiments above, wherein the resistance member contacts an inner surface along a distal end region of the carriage in the deployment configuration.

Alternatively or additionally to any of the embodiments above, wherein the carriage is configured to rotate, and wherein the resistance member is configured to increase a rotational force required to rotate the carriage in the deployment configuration.

An example method of manufacturing an implantable medical device includes:engaging the implantable medical device with a medical device delivery system in a pre-deployment configuration, the medical device delivery system including: an outer shaft having a distal end region, a proximal end region and a lumen extending therebetween;a handle coupled to the proximal end region of the outer shaft, wherein the handle includes a first actuator, a carriage and a housing;a cap coupled to the handle; anda resistance member disposed along a portion of the cap;converting the medical device delivery system from a pre-deployment configuration to a deployment configuration, wherein converting the medical device delivery system includes shifting the cap from a first position to a second position, wherein the carriage is free from the resistance member when the cap is in the first position and wherein the resistance member contacts the carriage when the cap is in the second position.

Alternatively or additionally to any of the embodiments above, wherein the implantable medical device includes an implantable heart valve.

DETAILED DESCRIPTION

Diseases and/or medical conditions that impact the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the system. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed, for example, where a blocked coronary artery could be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.

Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve or the mitral valve can have a serious effect on a human and could lead to serious health conditions and/or death if not dealt with properly. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used to deliver a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver a replacement heart valve (e.g., a replacement aortic valve, replacement mitral valve, etc.). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide additional benefits as described in more detail below.

The figures illustrate selected components and/or arrangements of a medical device system10, shown schematically inFIG. 1, for example. It should be noted that in any given figure, some features of the medical device system10may not be shown, or may be shown schematically, for simplicity. Additional details regarding some of the components of the medical device system10may be illustrated in other figures in greater detail.

The medical device system10may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy. In at least some embodiments, the medical device system10may include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a medical implant16, such as a replacement/prosthetic heart valve. This, however, is not intended to be limiting as the medical device system10may also be used for other interventions including valve repair, valvuloplasty, delivery of an implantable medical device (e.g., such as a stent, graft, etc.), and the like, or other similar interventions.

The medical device system10may generally be described as a catheter system that includes an outer shaft12, an inner shaft14(a portion of which is shown inFIG. 1) extending at least partially through a lumen of the outer shaft12, and a medical implant16(e.g., a replacement heart valve implant) which may be coupled to the inner shaft14and disposed within an implant containment region20coupled to the outer shaft12, the inner shaft14or both the outer shaft12and the inner shaft14during delivery of the medical implant16. In some embodiments, a medical device handle18may be disposed at a proximal end of the outer shaft12and/or the inner shaft14and may include one or more actuation mechanisms associated therewith. In other words, a tubular member (e.g., the outer shaft12, the inner shaft14, etc.) may extend distally from the medical device handle18. As will be described in greater detail below, the medical device handle18may be designed to manipulate the position of the outer shaft12relative to the inner shaft14and/or aid in the deployment of the medical implant16.

In use, the medical device system10may be advanced percutaneously through the vasculature to a position adjacent to an area of interest and/or a treatment location. For example, in some embodiments, the medical device system10may be advanced through the vasculature to a position adjacent to a defective native valve (e.g., aortic valve, mitral valve, etc.). Alternative approaches to treat a defective aortic valve and/or other heart valve(s) are also contemplated with the medical device system10. During delivery, the medical implant16may be generally disposed in an elongated and low profile “delivery” configuration within the implant containment region20, as seen schematically inFIG. 1for example. Once positioned, the outer shaft12and/or inner shaft14may be translated relative to each other and/or the medical implant16to expose (e.g., deploy) the medical implant16. In some instances, a portion of the medical implant16may be self-expanding such that exposure of the medical implant16may deploy the medical implant16. Alternatively, the medical implant16may be manipulated using the medical device handle18in order to translate the medical implant16into a deployed configuration suitable for implantation within the anatomy. When the medical implant16is suitably deployed within the anatomy, the medical device system10may be disconnected, detached, and/or released from the medical implant16and the medical device system10can be removed from the vasculature, leaving the medical implant16at the target tissue site.

As discussed above, the medical device system10may comprise an implant containment region20for accommodating the medical implant16in a collapsed form for introduction into the anatomy. The medical implant16may be a cardiac stent-valve. The delivery system10may be configured to permit delivery of the stent-valve16to a target site of implantation while the heart remains beating, for example, using a minimally invasive surgical and/or percutaneous procedure. In some embodiments, the delivery system10may be configured for introduction into the anatomical vascular system, and for advancement along the vasculature system to the desired site of implantation. For example, the delivery system10may be configured for introduction into the femoral artery, and guided retrograde via the descending aorta, aortic arch, and ascending aorta to the heart (sometimes called a transfemoral access). In other embodiments, the delivery system10may be insertable via the subclavian artery and guided retrograde to the heart (sometimes call transubclavian access). In other embodiments, the delivery system10may be inserted directly into a chamber of the heart such as a ventricle (for example, left ventricle) via a direct access route while the heart remains beating. For example, a direct access route may be through an aperture opened in the apex of the heart (sometimes called a transapical access).

It can be appreciated that during delivery and/or deployment of an implantable medical device (e.g., the medical implant16), portions of the medical device system10may be required to be advanced through tortuous and/or narrow body lumens. Therefore, it may be desirable to utilize components and design medical delivery systems (e.g., such as the medical device system10and/or other medical devices) that reduce the profile of portions of the medical device while maintaining sufficient strength (compressive, torsional, etc.) and flexibility of the system as a whole.

In some examples, the stent-valve16may be expandable from a compressed or collapsed condition to an expanded condition, in order to anchor the stent-valve16at the implantation site. For example, the stent-valve16may form a friction and/or interference fit with respect to the native anatomy. Various shapes and geometries of stent-valve16may be used to fit the anatomy at the site of implantation. The stent-valve16may be self-expanding and/or may be configured to be expandable by an expandable member (for example, a balloon). Self-expanding stent-valves16may be constructed from shape-memory material, for example, a shape-memory metal alloy (e.g., nitinol). The self-expanding stent-valve16may be retained in its compressed state by being constrained within the containment region20of the delivery system10. Upon at least partial release from the containment region20, the released portion of the stent-valve16may be free to expand. Balloon expandable stent-valves16may also be made of shape-memory material, stainless steel, cobalt-chromium alloy or other materials. A non-limiting list of materials contemplated for one or more components of the stent delivery system10described herein is set forth below.

FIG. 2illustrates an example first step in releasing (e.g., deploying) the stent-valve16from the medical device delivery system10. As shown inFIG. 2, the containment region20of the medical device delivery system10may comprise a first sheath22and/or a second sheath24. The first sheath22may be referred to as the distal sheath. The second sheath24may be referred to as the proximal sheath. Together, the first sheath22and the second sheath24may be translatable between a closed position (at least partially covering the stent-valve16) and an open position (at least partially exposing at least a portion of the stent-valve16). For example,FIG. 1illustrates both the first sheath22and the second sheath24(collectively referred to as the containment region20above) in a closed position (wherein they are covering the stent-valve16). Further,FIG. 2illustrates that the first sheath22and the second sheath24may be translatable in opposite directions to an open position, as described above. For example, the first sheath22may be translatable in a distal direction (indicated by arrow23inFIG. 2) while the second sheath24may be translatable in a proximal direction (indicated by arrow25inFIG. 2).

Additionally, in some instances, the first sheath22and the second sheath24may translate independent of one another to release of the stent-valve16from the medical device delivery system10. For example,FIG. 2illustrates that translating the second sheath24in a proximal direction (e.g., indicated by arrow25) while holding the first sheath22stationary, a portion26of the stent-valve16may be partially or fully released before a portion28of the stent-valve16covered by the first sheath22is partially or fully released. Further3illustrates that the portion28may subsequently be released by translation of the first sheath22in a distal direction (e.g., indicated by arrow23).

Additionally, in some examples, the length of the second sheath24may be greater than the length of the first sheath22. For example, the ratio of the second sheath24length divided by the first sheath22length may be at least 1.1, optionally at least 1.2, optionally at least 1.3, optionally at least 1.4, optionally at least 1.5, optionally at least 1.6, optionally at least 1.7, optionally at least 1.8, optionally at least 1.9, optionally at least 2.0, optionally at least 2.1, optionally at least 2.2, optionally at least 2.3, optionally at least 2.4, optionally at least 2.5, optionally at least 2.6, optionally at least 2.7, optionally at least 2.8, optionally at least 2.9, optionally at least 3, optionally at least 3.5, optionally at least 4 or optionally at least 4.5, or optionally at least 5.

FIG. 4shows an enlarged portion of the distal region of the medical device delivery system10described above. For example,FIG. 4illustrates the outer shaft12attached to the second (e.g., proximal) sheath24at a first connection point30. Additionally,FIG. 4illustrates the inner shaft14attached to a tip member34at a second connection region32. Further, the tip member34may be attached to the first (e.g., distal) sheath22. It can be appreciated that the tip member34may be designed with an atraumatic geometry, whereby the tip member34may include a tapered portion designed to ease navigation of the medical system10through challenging anatomical pathways. Additionally,FIG. 4illustrates that the inner shaft14may include a lumen36through which a guidewire may be advanced.

It can be appreciated fromFIG. 4that as the outer shaft12translates with respect to the inner shaft14, the second sheath24and the first sheath22will, correspondingly, translate with respect to one another. As will be described in greater detail below, as the outer shaft12and/or the inner shaft14are manipulated via the handle18(shown inFIG. 1), the second sheath24and/or the first sheath22may translate to release the medical implant16.

FIG. 5illustrates a cross-section of the handle18described above. The handle18may include a proximal end region17and a distal end region19.FIG. 5shows the outer shaft12(described above) and the inner shaft14(described above) entering the distal end region19of the handle18. The outer shaft12may be coupled (e.g., attached) to a translation member44. As shown inFIG. 5, the translation member44may be nested within a helical channel46disposed along a carriage40. The carriage40may be coupled (e.g., attached) to a first actuator38. It can be appreciated that the first actuator38may be designed to permit an operator to grasp and rotate the first actuator38, whereby rotation of the first actuator38may correspondingly rotate the carriage40. Further, rotation of the carriage40may rotate the helical channel46, thereby causing the translation member44to translate parallel to the longitudinal axis of the handle18. It can be appreciated that because the translation member44is attached to the outer shaft12, translation of the translation member44will translate the outer shaft12correspondingly. Further, in some examples, the first actuator38may be designed to rotate in both a clockwise and a counterclockwise direction, thereby permitting an operator to selectively translate the outer shaft12in both a distal-to-proximal direction and also a proximal-to-distal direction.

Additionally,FIG. 5illustrates that the handle18may include a second actuator39which is coupled to the inner shaft14. Further, it can be appreciated the second actuator39may be coupled to the inner shaft14via a similar mechanism as described with respect to the first actuator38. For example, the second actuator39may be coupled to the inner shaft14via a second translation member and second carriage48. Further, rotation of the second actuator39(either in a clockwise or a counter-clockwise direction) may translate the inner shaft14in a distal-to-proximal direction or a proximal-to-distal direction (depending on the direction of rotation of the second actuator39).

Further, as discussed above, because each of the outer shaft12and the inner shaft14are coupled to the second sheath24(not shown inFIG. 5, but described above) and the first sheath22(not shown inFIG. 5, but described above), manipulation of the first actuator38and/or the second actuator39may control the movement of the first sheath22and the second sheath24relative to one another. Additionally, it can be appreciated that it may be beneficial for either the first sheath22(not shown inFIG. 5, but described above) or the second sheath24(not shown inFIG. 5, but described above) to maintain its position while the second sheath24or the first sheath22is rotated. In other words, if an operator chooses to rotate the first actuator38(thereby translating the second sheath24), the handle18may be designed such that the second carriage48resists any back-loading forces placed upon it by the translation of the second sheath24(and/or the deployment of the medical implant). Correspondingly, if the operator chooses to rotate the second actuator39(thereby translating the first sheath22), the handle18may be designed such that the first carriage40resists any back-loading forces placed upon it by the translation of the first sheath22(and/or the deployment of the medical implant).

It can be appreciated, therefore, that, in some configurations, each of the first carriage40and second carriage48may need to be prevented from freely rotating (e.g., freely spinning) within the handle18. In other words, it may be beneficial to design the handle18to include one or more components which impart a frictional resistance to the rotation of each of the first carriage40and the second carriage48. It can be appreciated that this resistance may be translated to the first actuator38and the second actuator39, thereby requiring an operator to overcome the resistive force in order to rotate either of the first actuator38and the second actuator39. However, this resistance may provide increased control as an operator rotates either of the first actuator38and the second actuator39(when deploying the medical implant, for example).

To that end,FIG. 5shows that the handle18may include a housing42positioned overtop the first carriage40. In other words, the first carriage40may rotate inside an inner cavity of the housing42. Further,FIG. 5illustrates a cap50positioned along the distal end region of the handle18. Specifically, the cap50may extend into the distal end of the inner cavity of the housing42and also into at least a portion of the distal end region of the first carriage40. Additionally,FIG. 5illustrates that the handle18may include a resistance member66(e.g., gasket, rubber gasket, etc.) positioned along the proximal end region of the cap50. The resistance member66may exert an outward radial force upon the carriage40, thereby imparting a resistive force (as described above) to the rotation of the first carriage40. In other words, in order to rotate the first actuator38, an operator may have to overcome the radially outward force the resistance member66imparts onto the first carriage40.

While not shown in the figures, in some examples the medical device system10may include a third shaft (not shown for simplicity). The third shaft may be referred to as a “middle” shaft in some examples. The third shaft may be positioned between the inner shaft14and the outer shaft12. Further, the third shaft may extend from the handle18to a positioned adjacent the stent-valve16(described above). In some examples, the stent-valve16may be coupled to the third shaft. For example, the stent-valve16may be coupled to the third shaft via a stent-valve holder (not shown in the figures). Additionally, the third shaft may be stationary with respect to the outer shaft12, the inner shaft14or both the outer shaft12and the inner shaft14. In other words, as the outer shaft12and/or the inner shaft14are actuated (as described above), the third shaft may remain stationary relative thereto. It can be appreciated that the third shaft may provide a stable, stationary “platform” on which to mount the stent-valve16. For example, as the first sheath22and/or the second sheath24are translating with respect to one another (and the stent-valve16), the third shaft may prevent the stent-valve16from sliding (e.g., dragging) as the first sheath22and/or the second sheath24are translated.

In some examples, the third shaft (described above) may be coupled to an inner spine tube70(shown inFIG. 5). The inner spine tube70may be coupled to the housing42via a screw68. It can be appreciated that the inner spine tube70and/or the housing42may remain stationary as the outer shaft12and/or the inner shaft14are actuated by the first actuator38and the second actuator39, respectively.

FIG. 6shows a perspective view of the cap50described above. The cap50may include a proximal end region52, a distal end region54and a medial region64extending therebetween. Further, the cap50may include a lumen56extending from the proximal end region52to the distal end region54.FIG. 6further illustrates that the cap50may include a groove58(e.g., channel, etc.) positioned along the proximal end region52of the cap50. The groove58may extend circumferentially around the outer surface of the cap50. As will be shown in greater detail inFIG. 7, the groove58may extend radially inward from an outer surface of the cap50. Further, the groove58may be sized to accept the resistance member66(not shown inFIG. 6, but described above).

FIG. 6further illustrates that the cap50may include an aperture60positioned within the medial region64of the cap50. The aperture60may include a length “L.” In some examples, the aperture may extend longitudinally along the medial region64. Additionally, the cap50may include a lip62positioned along the distal end region54of the cap50. The lip62may extend circumferentially around and extend radially away from the outer surface of the cap50. In some examples, the lip62may include one or more tapered and/or curved surfaces63.

FIG. 7illustrates a cross section of the cap50shown inFIG. 6. For example,FIG. 7illustrates the groove58positioned along the proximal end region52of the cap50. Further,FIG. 7illustrates that the cap may include a wall thickness “Y” extending between the outer surface61and the inner surface65of the medial region64. As shown inFIG. 7, the groove58may extend only partially into the wall thickness “Y” of the cap50.

Additionally,FIG. 7illustrates the aperture60having a length “L” as described above. As shown inFIG. 7, the aperture60may extend entirely through the wall thickness “Y” of the cap50. However, this is not intended to be limiting. Rather, in some examples, the aperture may extend only partially through the wall thickness “Y” of the cap50. Further,FIG. 7illustrates the lip62extending radially outward from the outer surface61of the cap50. As discussed above, the lip62may include one or more tapered and/or curved surfaces63.

While the resistive force imparted by the resistance member66(described above) may provide increased control for an operator when deploying the medical implant, in some instances it may be desirable to selectively remove the resistive force imparted by the resistance member66on the second sheath24(via the connection of the first carriage40and the outer shaft12). Removing the resistive force may permit the second sheath24to more freely translate relative to the first sheath22.

For example, in some instances it may be desirable for an operator to engage (e.g., load) the medical implant into the first sheath22and/or the second sheath24. Further, in order to properly position the implant within the first sheath22and/or the second sheath24, the operator may be required to manipulate the first sheath22and/or the second sheath24relative to one another. It can be appreciated that loading the implant into the first sheath22and/or the second sheath24may require an operator to manipulate the first actuator38and/or the second actuator39at the handle (in order to adjust the spacing and position of the first sheath22and/or the second sheath24relative to one another). It can be appreciated that this may require the operator to physically move between the handle (at one end of the medical device system10) and the first and second sheaths22,24(at the opposite end of the medical device system10). Therefore, it may be desirable to design the handle18such that an operator can selectively remove the resistive force imparted to the first actuator38(and subsequently the second sheath24via the carriage40and outer shaft12). In other words, when the operator is loading the stent-valve, the resistive force may be removed, and subsequently, after loading (e.g., during insertion of the medical device system10into a patient's body) and/or when the operator is deploying the stent-valve, the resistive force may be applied.

To that end,FIG. 8illustrates a detailed view of the distal end region19of the medical device system10in a “pre-deployment” configuration. The pre-deployment configuration may represent a configuration which is designed to load the stent-valve into the first sheath22and/or the second sheath24(e.g., a configuration in which an operator can manipulate the second sheath24without having to use the handle18).

FIG. 8illustrates that the cap50(described above) has been shifted in a distal direction a distance “X.” Further,FIG. 8illustrates that shifting the cap50in a distal direction may correspondingly shift the resistance member66in a distal direction a distance “X.” Specifically, shifting the cap50in a distal direction may shift the resistance member66to a position in which it is free from (e.g., not contacting) the inner surface74of the first carriage40. As shown inFIG. 8, the resistance member66is positioned adjacent to an inner surface67of the housing42, thereby removing the resistive force from the carriage40.

FIG. 8further illustrates that the handle18may include a screw68which is positioned at least partially within the aperture60of the cap50. It can be appreciated that the screw68may be prevent the cap from sliding all the way out the distal end of the housing42. Additionally, it can be appreciated that the length of the aperture60(described as length “L” inFIG. 6andFIG. 7corresponds to the distance “X” the cap shifts in the distal direction.

FIG. 9illustrates a detailed view of the distal end region19of the medical device system10in a “deployment” configuration. The deployment configuration may represent a configuration which is designed to advance the system through a blood vessel and/or deploy the medical implant at a target site, for example.FIG. 9illustrates that the cap50(described above) has been shifted in a proximal direction (shown by the arrows72) such that the resistance member66contacts the inner surface74of the carriage40. As described above, in this configuration, the resistance member66may exert a radially outward force upon the inner surface74of the carriage40, which, in turn, imparts a resistive force on the first actuator38(not shown inFIG. 9) and the second sheath24(not shown inFIG. 9).

FIG. 9further illustrates that the lip62of the cap50may be shifted proximally such that it contacts the distal end of the housing42. It can be appreciated that the lip62may be designed to permit an operator to engage a portion thereof, which may permit the operator to more easily shift the cap50between the pre-deployment configuration and the deployment configuration. Further, the lip62may have a profile (e.g., a beveled edge) that sits flush with the housing42, in order to reduce the exposed profile of the cap50. This feature may reduce the risk of the cap50being moved accidentally out of the proximal position (after the cap50has been placed in the proximal position for implanting a loaded stent-valve16).

FIG. 10illustrates another example cap150. The cap150may be similar in form and function to the cap50. For example,FIG. 10shows that the cap150may include an aperture160positioned in the medial region164of the cap150. However, as illustrated inFIG. 10, the aperture160may be offset from the longitudinal axis155of the cap150. It can be appreciated that offsetting the aperture160from the longitudinal axis155of the cap150may allow the resistance member to be shifted between the pre-deployment configuration and the deployment configuration via “rotating” the cap150. In other words, instead of requiring an operator to slide the cap150linearly along the longitudinal axis (as described inFIG. 8andFIG. 9), the cap configuration shown inFIG. 10may allow the resistance member66shift longitudinally as the cap150is being rotated.

As discussed above, in some instances it may be desirable for an operator to engage (e.g., load) a medical implant into the first sheath22and/or the second sheath24. Further, in order to properly load a medical implant within the first sheath22and/or the second sheath24, the operator may be required to manipulate (e.g., shift) the first sheath22and/or the second sheath24relative to one another. Therefore, in some instances, it may be beneficial for an operator to use a medical implant loading device (e.g., stent-valve loader) to help advance the first sheath22and/or the second sheath24relative to one another to cover and contain a medical implant within the first sheath22and/or the second sheath24.

FIG. 11illustrates an example medical implant loading device80. The medical implant loading device80may be utilized by an operator to load a stent-valve16(shown above) into the first sheath22and/or the second sheath24prior to performing a medical procedure.FIG. 11illustrates the medical implant loading device80in a configuration in which the medical implant16has already been loaded within the medical implant loading device80. In other words, the first sheath22, the second sheath24and the medical implant16are not visible inFIG. 11(as they are positioned within the medical implant loading device80).

However,FIG. 11does illustrate that the medical implant loading device80may include a knob82coupled to a stem84.FIG. 11further illustrates the outer shaft12(described above) extending into the stem84. Additionally,FIG. 11shows that the implant loading device may include a sleeve86(visible through an aperture located in the stem84). As will be described in greater detail below, it can be appreciated that the knob82may be rotated with respect to the stem84. Rotation of the knob82with respect to the stem84may translate the first sheath22(described above) longitudinally with respect to the second sheath24(described above).

FIG. 12illustrates an exploded view of the medical implant loading device80described above. For example,FIG. 12illustrates the knob82and the stem84. Further,FIG. 12illustrates that the stem84may include a threaded portion85positioned along an end region thereof. As will be described in greater detail with respect toFIG. 13below, the threaded portion85may be utilized to couple the knob82with the stem84.

FIG. 12further illustrates the sleeve86described above. As shown inFIG. 12, the sleeve86may separate into a first sleeve portion87aand a second sleeve portion87b.The first sleeve portion87aand the second sleeve portion87bmay engage with one another in a “clamshell” configuration to form sleeve86. The sleeve86may include proximal end region91and a distal end region93. Additionally,FIG. 12shows the outer shaft12extending through the stem84. It can be appreciated that the stem84may be slid onto and overtop the first sheath22and the second sheath24such that the stem84is positioned proximal to the second sheath24. Additionally, the sleeve86may be positioned within portion of an interior cavity of the stem84and/or the knob82.

As described above,FIG. 12further illustrates the outer shaft12coupled to the second sheath24. In some examples, the distal end region of the outer shaft12may include a tapered region92. The tapered region92may extend from the distal end region of the outer shaft12to the proximal end of the second sheath24. Additionally,FIG. 12illustrates the tip member34(described above) extending into an extension member90. The extension member90may extend in a proximal-to-distal direction from the tip member34.

As discussed above, the medical implant loading device80may be utilized to load a medical device (e.g., a stent-valve) into the first sheath22and/or the second sheath24. The medical implant loading device80may be configured to apply an axial force to the first sheath22and/or the second sheath24as part of the loading operation. These axial forces may be designed to urge movement of the first sheath22and/or the second sheath24toward one another to cover all, or a portion of, the stent-valve16. As discussed above, it can be appreciated that the ability to release the resistance of the first actuator38and/or the second actuator39(described above) within the handle (for example, by moving the cap50to its distal position as described above) may allow the first actuator38and/or the second actuator39to move freely as the knob82and/or the stem84are rotated (and, therefore, axially translated) with respect to one another. It can be appreciated that permitting the first actuator38and/or the second actuator39to move freely as the knob82shifts relative to the stem84may facilitate the loading of the stent-valve16(illustrated inFIGS. 1-4) by permitting the operator to remain at the distal end of the catheter, rather than having to physically move repeatedly between the handle and the distal end of the catheter to “mirror” the relative movement of the first sheath22and the second sheath24with the first actuator38and the second actuator39.

FIG. 13illustrates a cross-section of the medical implant loading device80. For simplicity,FIG. 13does not show a medical implant positioned between the first sheath22and the second sheath24. However, it can be appreciated that an operator may position the medical implant (e.g., a stent-valve16) between the first sheath22and the second sheath24prior to moving the first sheath22relative to the second sheath24via the medical implant loading device80. As described above, in some instances the medical implant may be coupled to a third shaft (described above), whereby the third shaft may extend between the first sheath22and the second sheath24.

It can be appreciated fromFIG. 13that rotation of the knob82may apply a proximally-directed force to the first sheath22(via the extension member90). For example, the knob82may include an inner surface profile which engages the extension member90. Further,FIG. 13illustrates that the knob82may include a threaded portion89designed to mate with the threaded portion85along the distal end region of the stem84.

FIG. 13shows that the extension member90may abut (directly or indirectly) the tip member34(or any other member attached to the tip member34) of the first sheath22. Further, it can be appreciated fromFIG. 13that rotation of the stem84may apply a distally-directed force to the second sheath24via sleeve86.FIG. 13illustrates that the sleeve86(including the first sleeve portion87aand the second sleeve portion87b) may be positioned within the stem84. Further, the second sheath24and all (or a portion of) the first sheath22may be positioned within the sleeve86. Additionally,FIG. 13illustrates that the distal end region91of the sleeve86may include a (e.g. tapered) surface which engages the tapered portion92of the outer shaft12.

As described above, an operator may rotate either the knob82and/or the stem84to progressively apply an axially compressive force between the knob82and the stem84to move the first sheath22and/or the second sheath24closer toward one another. This may permit an operator to load a stent-valve into the first sheath22and/or the second sheath24while working primarily at the distal end of the catheter. The medical implant loading device80may apply the axial forces at the distal end to close the first sheath22and/or the second sheath24over the stent valve as part of the loading operation. As described above, it can be appreciated that the ability to release the resistance of the first actuator38and/or the second actuator39within the handle18(by shifting the cap50to its distal position, for example) and may improve the speed and efficiency in which an operator may load a medical implant prior to performing a medical procedure.

The materials that can be used for the various components of the medical devices and/or systems disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to the medical device delivery system10including the various components of the medical device delivery system10.

In at least some embodiments, portions or all of the medical device delivery system10may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the shaft in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device delivery system10to achieve the same result.