Medical device delivery system

Abstract

Delivery systems are used in medical devices. For example, this document describes delivery systems for implantable medical devices such as artificial heart valves that can be delivered minimally invasively using a catheter system, but is not limited to these.

Description

Technical Field

[0001] 1. Technical Field This document relates to delivery systems for medical devices and methods for their use. For example, this document relates to delivery systems for implantable medical devices such as artificial heart valves that can be delivered minimally invasively using a catheter system.

Background Art

[0002] 2. Background Some artificial heart valves can be delivered in a minimally invasive manner to avoid open chest surgery. Such artificial heart valves can be delivered using a catheter system, and these catheters are operated by a clinician using an actuator handle and / or other types of control mechanisms that remain positioned outside the patient's body. For example, in some such cases, the artificial heart valve is compressed to fit into a delivery catheter or sheath, and this delivery catheter or sheath may be manually deflectable by adjusting a mechanism located on the actuator handle.

[0003] An artificial aortic valve can be delivered to the native aortic heart valve site using a transcatheter aortic valve replacement (TAVR) delivery system. Clinicians sometimes encounter difficulties when delivering an artificial aortic valve minimally invasively using such a catheter-based delivery system. One such difficult area relates to the task of guiding the artificial aortic valve through the aortic arch pathway during the process of reaching the position of the native aortic heart valve.

Summary of the Invention

[0004] This document describes delivery systems for medical devices and methods for their use. For example, this document describes delivery systems for implantable medical devices such as, but not limited to, artificial heart valves that can be delivered minimally invasively using a catheter system.

[0005] In one embodiment, the present disclosure relates to a medical device system comprising: a maneuverable catheter defining a first lumen; a pull wire including a distal end coupled to the distal end portion of the maneuverable catheter; a balloon catheter slidably disposed within the first lumen, the balloon catheter including an inflatable balloon member at the distal end portion of the balloon catheter; and a handle device. The handle device comprises (a) a housing, (b) a first rotatable actuator knob rotatably coupled to the housing, the first rotatable actuator knob having a sleeve with an internal thread, (c) a traveler guide shaft extending inward within the sleeve, the proximal end of a maneuverable catheter fixed to the traveler guide, (d) a deflection nut having a male thread engaging with the internal thread of the sleeve, defining a bore having a non-circular cross-section in which the traveler guide slidably extends, the proximal end of a pull wire coupled to the deflection nut, and (e) a balloon catheter pull rod extending proximal from the housing, the proximal end of a balloon catheter being a balloon The device includes: (f) a balloon catheter pull rod fixed to a catheter pull rod; (g) a locking mechanism rotatably coupled to a housing and manually adjustable between a locked position and an unlocked position, configured to release the balloon catheter relative to the housing when the locking mechanism is in the locked position; and (g) a second rotatable actuator knob rotatably coupled to the housing, configured to rotate the balloon catheter pull rod and the balloon catheter while allowing the balloon catheter pull rod to translate longitudinally relative to the second rotatable actuator knob when the locking mechanism is in the unlocked position.

[0006] Such a medical device delivery system may optionally include one or more of the following features: The balloon catheter pull rod may be longitudinally slidable relative to a second rotatable actuator knob and housing when the locking mechanism is in the unlocked position. The medical device delivery system may also include a collet. The balloon catheter may pass through the collet. When the locking mechanism is in the locked position, the collet may radially compress the balloon catheter. The medical device delivery system may also include a deflection indicator coupled to the housing and configured to visually indicate the degree of deflection of the maneuverable catheter. The medical device delivery system may also include a mechanism that generates audible feedback in response to the deflection of the maneuverable catheter.

[0007] In another aspect, the Disclosure relates to a method for delivering an artificial aortic valve to a patient using one of the medical device delivery systems described herein. The method comprises (1) adjusting a locking mechanism to a locked position; (2) advancing the medical device delivery system on a guidewire to position the artificial aortic valve at the location of the patient's natural aortic valve, with the locking mechanism in the locked position, wherein the advancing includes adjusting a first rotatable actuator knob to deflect the maneuverable catheter and balloon catheter to correspond to the patient's aortic arch; (3) adjusting the locking mechanism to an unlocked position with the artificial aortic valve at the location of the patient's natural aortic valve; (4) pulling the housing proximal while maintaining the balloon catheter pull rod in a stationary position with the locking mechanism in the unlocked position; and (5) adjusting a second rotatable actuator knob to rotate the balloon catheter and artificial aortic valve relative to the maneuverable catheter with the locking mechanism in either the unlocked or locked position. (6) adjusting the locking mechanism to the locked position; (7) advancing or retracting the handle device, balloon catheter, and artificial aortic valve to position the artificial aortic valve longitudinally at a desired location relative to the annulus of the patient's natural aortic heart valve while the locking mechanism is in the locked position; (8) inflating the balloon member to expand the artificial aortic valve and engage it with the patient's natural aortic heart valve; (9) deflating the balloon member; (10) adjusting the locking mechanism to the unlocked position; (11) pulling the balloon catheter pull rod proximal to the housing to retract the balloon catheter into the first lumen of the maneuverable catheter while the locking mechanism is in the unlocked position; (12) adjusting the locking mechanism to the locked position; and (13) retracting the handle device, maneuverable catheter, and balloon catheter from the patient while the locking mechanism is in the locked position.

[0008] Certain embodiments of the subject matter described herein may be implemented to achieve one or more of the following advantages. In some embodiments, the medical device delivery system described herein is conveniently designed to allow rotational adjustment of the catheter to which the artificial heart valve is attached in order to facilitate the desired alignment of the structure of the artificial heart valve with the commissure of the innate heart valve. In some embodiments, a maneuverable catheter is included as part of the medical device delivery system described herein, and such a maneuverable catheter can be controllably deflected by 180° or more. Such deflection is advantageous during the manipulation of the catheter in the patient's body, including, for example, passing through the aortic arch. In some such embodiments, a deflection indicator is included on the control handle of the medical device delivery system described herein. Such an indicator is convenient for the clinician by providing an easily accessible indicator of the amount of deflection of the catheter in the patient's body. In some embodiments, a locking mechanism is included on the control handle of the medical device delivery system described herein. Such a locking mechanism can be operated to conveniently lock the catheters of the medical device delivery system together with each other during the forward and backward steps of the medical device deployment process. Furthermore, the locking mechanism can be unlocked to allow relative movement of the catheters together, as described herein.

[0009] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art in which the invention pertains. The invention can be carried out using methods and materials similar or equivalent to those described herein, but preferred methods and materials are described herein. All publications, patent applications, patents, and other references referenced herein are incorporated in their entirety by reference. In case of any conflict, this specification, including definitions, shall prevail. Furthermore, materials, methods, and examples are illustrative and not intended to limit the scope.

[0010] Details of one or more embodiments of the present invention are described in the accompanying drawings and this description. Other features, purposes, and advantages of the present invention will become apparent from the description and drawings and the claims. [Brief explanation of the drawing]

[0011] [Figure 1] This is a perspective view of an exemplary medical device delivery system according to some embodiments provided herein. [Figure 2] Figure 1 is an enlarged cross-sectional view of the distal end portion of the medical device delivery system. [Figure 3] Figure 1 is an enlarged view of an exemplary handle for a medical device delivery system. [Figure 4] Figure 1 is a longitudinal cross-sectional view of the handle of the medical device delivery system. [Figure 5] This is a flowchart illustrating exemplary methods for delivering medical devices according to several embodiments. [Modes for carrying out the invention]

[0012] Similar reference symbols represent corresponding parts throughout the whole. This document describes delivery systems for medical devices and methods for their use. For example, this document describes delivery systems for implantable medical devices such as, but not limited to, artificial heart valves that can be delivered minimally invasively using a catheter system.

[0013] Figure 1 shows an exemplary transcatheter medical device delivery system 100. In the illustrated example, the medical device delivery system 100 is configured to deliver an artificial heart valve to the site of the original heart valve by advancing the artificial heart valve through the patient's vascular system to the heart. For example, in some embodiments, the medical device delivery system 100 can be used to deliver an artificial aortic valve to the site of the original aortic valve via the patient's aorta. This non-limiting type of use of the medical device delivery system 100 is used herein as an example to illustrate the functionality of the medical device delivery system 100. In such a case, the medical device delivery system 100 may be inserted into the femoral artery and then advanced into the aorta, through the aortic arch, to the site of the original aortic valve. Alternative approaches such as transclavicular, transcarotid, transradial, and others are also conceivable using the medical device delivery system 100.

[0014] Broadly speaking, the medical device delivery system 100 includes a clinical control handle 110 (or simply "handle 110"), a maneuverable catheter 160, and a balloon catheter 170. The maneuverable catheter 160 and the balloon catheter 170 each extend distally from the handle 110. The maneuverable catheter 160 and the balloon catheter 170 are each fixed to the handle 110, but at different positions on the handle 110 (as will be further described below).

[0015] Figure 2 shows an enlarged cross-sectional view of the distal ends of the maneuverable catheter 160 and balloon catheter 170. As shown, the maneuverable catheter 160 defines a lumen in which the balloon catheter 170 is slidably positioned. That is, the balloon catheter 170 can be advanced and / or retracted relative to the maneuverable catheter 160 by being manipulated by a clinician (using the handle 110) and sliding the balloon catheter 170 within the lumen of the maneuverable catheter 160.

[0016] The maneuverable catheter 160 is controllable deflection or maneuverability by a clinician (by manipulating the pull wire 164 using the handle 110, as further described below with reference to Figure 4). Specifically, the distal end portion of the maneuverable catheter 160 is controllable deflection to any desired angle up to approximately 180°, or, in some embodiments, controllable deflection to angles greater than 180°. When the maneuverable catheter 160 is deflected in this manner, the balloon catheter 170 also takes on a similar degree of deflection (due to the balloon catheter 170 being positioned within the lumen of the maneuverable catheter 160). The deflection of the maneuverable catheter 160 (and the balloon catheter 170) may be useful, for example, for passing through the aortic arch.

[0017] Referring further to Figure 2, the balloon catheter 170 includes a catheter shaft 172 and a balloon 174 attached to the distal end of the catheter shaft 172. The wall of the catheter shaft 172 defines an inflation lumen (not shown), through which inflation fluid can be supplied and withdrawn to controllably inflate and / or deflate the balloon 174. Furthermore, the catheter shaft 172 defines a central lumen 176, which allows the balloon catheter 170 (and the maneuverable catheter 160) to be advanced on the guidewire. A tapered nose cone 178 extends distally from the balloon 174.

[0018] An artificial heart valve with a radially compressed configuration can be positioned on the balloon 174. Once the balloon 174 and the artificial heart valve are positioned at the target location and in the desired orientation relative to the patient's anatomical structure, the balloon 174 can be inflated to radially expand the artificial heart valve and engage it with the patient's innate anatomical structure (e.g., engage it with the annulus of a natural heart valve, such as the natural aortic valve). Subsequently, the balloon 174 can be deflated and retracted from the artificial heart valve. In some embodiments, radiopaque markers can be positioned at one or more locations on the maneuverable catheter 160 and / or balloon catheter 170 to provide fluoroscopic visualization of the maneuverable catheter 160 and / or balloon catheter 170.

[0019] Figure 3 shows an enlarged view of an exemplary handle 110 of the medical device delivery system 100. While the handle 110 remains outside the patient's body, the maneuverable catheter 160 and balloon catheter 170 extend into the patient's body (e.g., into the patient's vascular system). The handle 110 includes several control mechanisms, which allow a clinician operator to remotely control various aspects of the maneuverable catheter 160 and balloon catheter 170, as will be further described below.

[0020] This figure of the handle 110 illustrates the following components and / or control mechanisms of the handle 110. Specifically, the handle 110 includes a housing 112, a rotatable first actuator knob 114, a lock actuator 116, a rotatable second actuator knob 118, a balloon catheter pull rod 120, a flush line 122, and an optional deflection indicator 180. The first actuator knob 114, the second actuator knob 118, and the lock actuator 116 are each manually rotatable relative to the housing 112. The balloon catheter pull rod 120 is manually translational relative to the housing 112 (when the lock actuator 116 is in its unlocked position, as will be further described below).

[0021] Figure 4 is a longitudinal cross-sectional view of the handle 110. Accordingly, the internal components of the handle 110 are visible here. For example, it can be seen here that the first actuator knob 114 includes (or is coupled to) a sleeve 115 having an internal thread. The sleeve 115 rotates around the longitudinal axis of the handle 110 as the first actuator knob 114 is manually rotated by the clinician.

[0022] The deflection nut 119 is disposed movably within the sleeve 115. The deflection nut 119 has an external thread that engages the internal thread of the sleeve 115. The deflection nut 119 defines a longitudinal bore having a non-circular cross-section.

[0023] The handle 110 also includes a traveler guide 117. As the first actuator knob 114 is manually rotated by the clinician, the deflection nut 119 translates slidably along the traveler guide 117. The shape of the external profile of the traveler guide 117 enables the deflection nut 119 to translate slidably along the traveler guide 117 while preventing or precluding rotation of the deflection nut 119 relative to the traveler guide 117 and the housing 112. For example, in some embodiments, the cross-sectional shape of the longitudinal bore of the deflection nut 119 and the external profile of the traveler guide 117 are quadrilateral (such as rectangular or square). Various other shapes or arrangements (such as other polygons, splines, keys, and keyways, etc.) can also be used to enable the deflection nut 119 to translate slidably along the traveler guide 117 while preventing or precluding rotation of the deflection nut 119 relative to the traveler guide 117 and the housing 112.

[0024] The proximal end of the steerable catheter 160 is fixed to the traveler guide 117. The flush line 122 is attached to the traveler guide 117 and is thereby arranged to facilitate fluid flushing of the lumen of the steerable catheter 160.

[0025] The medical device delivery system 100 also includes a pull wire 164. The distal end of the pull wire 164 is coupled to the distal end portion of the steerable catheter 160. The proximal end of the pull wire 164 is coupled to the deflection nut 119. Thus, by a proximally directed translational movement of the deflection nut 119, tension is applied to the pull wire 164 (causing deflection of the steerable catheter 160). Conversely, by a distally directed translational movement of the deflection nut 119, the tension in the pull wire 164 is relaxed (enabling the steerable catheter 160 to elastically return towards its natural straight shape). Thus, the degree of deflection of the steerable catheter 160 (and the balloon catheter 170 disposed therein) can be controlled using manual rotation of the first actuator knob 114.

[0026] As described above, the handle 110 can optionally include a deflection indicator 180. The deflection indicator 180 has a screw that mates with the male thread of the sleeve 115. Thus, as the first actuator knob 114 is manually rotated by the clinician, the male thread of the sleeve 115 drives the deflection indicator 180 to translate longitudinally relative to the housing 112. That translational movement of the deflection indicator 180 is visible through an opening defined by the housing 112 (see FIG. 3). The translational movement of the deflection indicator 180 is proportional to the degree of deflection of the steerable catheter 160 (and the balloon catheter 170 disposed therein).

[0027] The proximal end of the balloon catheter 170 is fixed to the balloon catheter pull rod 120. In the illustrated embodiment, the balloon catheter pull rod 120 is slidably coupled to the second actuator knob 118 using an engagement between the arrangement of a key and a keyway. That is, in the illustrated embodiment, the balloon catheter pull rod 120 includes a longitudinally extending key slidably positioned in a longitudinally extending keyway defined by the second actuator knob 118. Thus, the balloon catheter pull rod 120 is longitudinally translatable relative to the second actuator knob 118 (when the lock actuator 116 is in its unlocked position) and is always restricted from rotating relative to the second actuator knob 118. In other words, when a clinician manually rotates the second actuator knob 118, the balloon catheter pull rod 120 (and the balloon catheter 170 fixed to it) also rotates. In addition, when the clinician manually pulls or pushes the balloon catheter pull rod 120 (while the lock actuator 116 is in its unlocked position), the balloon catheter 170 is consequently moved proximal or distal to the maneuverable catheter 160 and handle 110.

[0028] The locking mechanism of the handle 110 includes a lock actuator 116. The lock actuator 116 is rotatably coupled to the housing 112. In the illustrated embodiment, the lock actuator 116 includes a male screw that engages with the threads of the housing 112. Thus, as the clinician rotates the lock actuator 116 relative to the housing 112, the lock actuator 116 also moves longitudinally relative to the housing 112.

[0029] The locking mechanism of the handle 110 also includes a collet 121. A portion of the balloon catheter 170 passes through the inner diameter of the collet 121. In the illustrated embodiment, the portion of the balloon catheter 170 passing through the inner diameter of the collet 121 includes a hypotube.

[0030] The collet 121 has a tapered outer diameter that slidably engages with the corresponding tapered inner diameter of the lock actuator 116. Therefore, as the clinician rotates the lock actuator 116 relative to the housing 112, the lock actuator 116 moves longitudinally relative to the housing 112, causing the taper of the lock actuator 116 to either compress or return the collet 121 (and the portion of the balloon catheter 170 positioned within the collet 121) to its uncompressed state. Thus, by operating the lock actuator 116 to its locked position, the balloon catheter 170 is longitudinally locked relative to the housing 112. Conversely, by operating the lock actuator 116 to its unlocked position, the balloon catheter 170 is longitudinally unlocked (and becomes movable) relative to the housing 112. In contrast, the maneuverable catheter 160 is always longitudinally locked (and rotationally locked) relative to the housing 112.

[0031] When the lock actuator 116 is in its locked position, the balloon catheter 170 is locked longitudinally and therefore immovable longitudinally relative to the housing 112. However, when the lock actuator 116 is in its unlocked position, the balloon catheter 170 is movable longitudinally relative to the housing 112 and the maneuverable catheter 160 (by pulling or pushing the balloon catheter pull rod 120). When the lock actuator 116 is in its unlocked position, and when the lock actuator 116 is in its locked position, the balloon catheter 170 is movable rotationally relative to the housing 112 and the maneuverable catheter 160 (by rotating the second actuator knob 118).

[0032] Figure 5 is a flowchart of an exemplary method 200 for the delivery and deployment of a medical device using a medical device delivery system 100. Specifically, the exemplary method 200 is for the delivery of an artificial aortic valve using the medical device delivery system 100. Each step of method 200 will be described, and with reference to Figures 1 to 4, how a clinician can operate the medical device delivery system 100 to perform the steps of method 200 will be explained.

[0033] This method 200 may be performed by a clinician, possibly using fluoroscopic imaging (and / or other types of imaging). Furthermore, other conventional steps for preparing the medical device delivery system 100 (e.g., flushing, testing, etc.) may be performed before the first step 210, but are not specifically included in the flowchart of Figure 5.

[0034] In the first step 210 of Method 200, the guidewire is inserted into the patient. For example, in some embodiments, the guidewire is inserted into the femoral artery and then guided into the aorta, across the aortic arch and across the aortic valve. The distal end of the guidewire is located in the patient's left ventricle.

[0035] In step 220, with the lock actuator 116 in the locked position, the medical device delivery system 100 (having an artificial aortic valve mounted in a radially compressed configuration on a balloon 174) is advanced along the guidewire. As the balloon catheter 170 and the maneuverable catheter 160 are advanced beyond the aortic arch, the clinician can deflect the maneuverable catheter 160 (and the balloon catheter 170 contained within it) accordingly. That is, the clinician can rotate the first actuator knob 114 relative to the housing 112 to apply tension to the pull wire 164, resulting in a deflection of the maneuverable catheter 160 (and the balloon catheter 170 contained within it) that helps it pass through the aortic arch. The advancement in step 220 can be continued until the artificial aortic valve is positioned within the natural aortic valve.

[0036] In step 230, with the artificial aortic valve remaining roughly positioned within the natural aortic valve, the clinician can move the lock actuator 116 to its unlocked position and then pull the housing 112 proximal while holding the balloon catheter pull rod 120 in a roughly stationary position. These actions pull the maneuverable catheter 160 back relative to the balloon catheter 170 (and the artificial heart valve mounted on it). As a result, the balloon catheter pull rod 120 extends into the housing 112.

[0037] Next, in step 240, with the lock actuator 116 still in its unlocked or locked position, the clinician can rotate the balloon catheter 170 (and the artificial heart valve mounted thereon) to align the structural features of the artificial heart valve with the anatomical features of the innate aortic valve. The clinician can perform this step by rotating the second actuator knob 118 relative to the housing 112. The balloon catheter 170 will rotate in response to the rotation of the second actuator knob 118, while the maneuverable catheter 160 remains stationary. Using fluoroscopy, the clinician can observe radiopaque markers on the artificial heart valve and align the artificial heart valve to the desired orientation relative to the innate heart valve anatomical structure (e.g., relative to the commissure of the innate heart valve). Once the desired orientation is achieved, the clinician can then operate the lock actuator 116 to its locked position (if the lock actuator 116 is not already in the locked position).

[0038] In step 250, with the lock actuator 116 in its locked position, the clinician can then advance or retract the medical device delivery system 100 (with the artificial heart valve still mounted on the balloon 174 of the balloon catheter 170) to position the artificial heart valve at a desired longitudinal position relative to the annulus of the natural aortic valve. In some embodiments, the artificial heart valve may include radiopaque markers indicating where the artificial heart valve should be positioned longitudinally relative to the annulus of the natural aortic valve. To perform this step, the clinician may simply push the handle 110 distally or pull the handle 110 proximal.

[0039] In step 260, with the lock actuator 116 still in its locked position, the clinician can then inflate the balloon 174 to expand the prosthetic heart valve and bring it into contact with the annulus of the natural aortic valve. For example, the clinician can inflate the balloon 174 (and expand the prosthetic heart valve) by injecting an inflation fluid (e.g., saline solution) into the inflation lumen of the balloon catheter 170 through the port 123 extending from the balloon catheter pull rod 120.

[0040] In step 270, with the lock actuator 116 still in its locked position, the clinician can then deflate the balloon 174 (to uncouple the balloon 174 from the prosthetic heart valve, which remains engaged with the annulus of the natural aortic heart valve). To deflate the balloon 174, the clinician can withdraw the inflation fluid from the balloon 174 by performing the reverse of the inflation step. The clinician can then operate the lock actuator 116 to its unlocked position.

[0041] In step 280, with the lock actuator 116 in its unlocked position, the clinician can retract the balloon catheter 170 relative to the maneuverable catheter 160. To do this, the clinician can pull the balloon catheter pull rod 120 proximal while keeping the housing 112 in a nearly stationary position. The clinician can then operate the lock actuator 116 to its locked position.

[0042] In step 290, with the lock actuator 116 in the locked position, the clinician can then retract the medical device delivery system 100 and guidewire proximal to the patient to complete method 200. The artificial heart valve remains engaged in a functional position with the annulus of the natural aortic heart valve.

[0043] Characteristics of voluntary selection In some embodiments, the handle 110 includes tactile and / or audible feedback indicating the deflection adjustment process of the maneuverable catheter 160 resulting from the operation of the first actuator knob 114.

[0044] In some embodiments, the lock actuator 116 includes a friction member that applies friction between the lock actuator 116 and the housing 112. In some embodiments, the deflection indicator 180 is included as part of the handle 110.

[0045] In some embodiments, a thin elastomer coating is included in the hypotube portion (inside the housing 112) of the balloon catheter 170. This specification includes many specific implementation details, which should not be interpreted as limiting the scope of any invention or the scope of the claimed subject matter, but rather as descriptions of features that may be specific to a particular embodiment of a particular invention. Certain features described herein in relation to separate embodiments may also be implemented in combination in one embodiment. Conversely, various features described in the context of one embodiment may also be implemented separately in multiple embodiments or in any preferred partial combination. Furthermore, even if features are described herein as acting in a particular combination and initially claimed as such, one or more features from the claimed combination may, in some cases, be removed from that combination, and the claimed combination may cover a partial combination or a variation of a partial combination.

[0046] Similarly, while operations are shown in a specific order in the diagrams, this should not be understood as requiring that such operations be performed in a specific or sequential order, or that all illustrated operations be performed, in order to achieve the desired result. In certain situations, multitasking and parallel processing may be advantageous.

[0047] Specific embodiments of the subject matter have been described. Other implementations are also within the scope of the following claims. For example, the desired results can still be achieved even if the operations listed in the claims are performed in a different order. As an example, the process illustrated in the accompanying drawings does not necessarily require the specific order or sequence shown to achieve the desired results.

Claims

1. A medical device delivery system, A maneuverable catheter for defining the first lumen, A pull wire including a distal end connected to the distal end portion of the controllable catheter, A balloon catheter slidably disposed within the first lumen, comprising an inflatable balloon member at the distal end portion of the balloon catheter, A handle device, Housing and A first rotatable actuator knob rotatably coupled to the housing, comprising a sleeve having an internal thread, A traveler guide shaft extending inward within the sleeve, wherein the proximal end of the maneuverable catheter is fixed to the traveler guide; A deflection nut having a male thread that engages with the female thread of the sleeve, defining a bore having a non-circular cross-section in which the traveler guide slidably extends, wherein the proximal end of the pull wire is coupled to the deflection nut, A balloon catheter pull rod extending proximal to the housing, wherein the proximal end of the balloon catheter is fixed to the balloon catheter pull rod, A locking mechanism rotatably coupled to the housing and manually adjustable between a locked position and an unlocked position, wherein the locking mechanism is configured to releasably position the balloon catheter relative to the housing when it is in the locked position, A second rotatable actuator knob rotatably coupled to the housing, wherein the second rotatable actuator knob is configured to rotate the balloon catheter pull rod and the balloon catheter, while allowing the balloon catheter pull rod to translate longitudinally relative to the second rotatable actuator knob when the locking mechanism is in the unlocked position, A handle device equipped with, A medical device delivery system equipped with the following features.

2. The medical device delivery system according to claim 1, wherein the balloon catheter pull rod is longitudinally slidable relative to the second rotatable actuator knob and the housing when the locking mechanism is in the unlocked position.

3. With an additional collet, The medical device delivery system according to claim 1 or 2, wherein the balloon catheter passes through the collet.

4. The medical device delivery system according to claim 3, wherein when the locking mechanism is in the locked position, the collet compresses the balloon catheter radially.

5. The medical device delivery system according to claim 1 or 2, further comprising a deflection indicator coupled to the housing and configured to visually indicate the degree of deflection of the maneuverable catheter.

6. The medical device delivery system according to claim 1 or 2, further comprising a mechanism for generating audible feedback in response to the deflection of the controllable catheter.

Images