(19)
(11)EP 3 215 027 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
29.04.2020 Bulletin 2020/18

(21)Application number: 15787421.5

(22)Date of filing:  20.10.2015
(51)International Patent Classification (IPC): 
A61B 17/122(2006.01)
A61B 17/068(2006.01)
A61B 17/128(2006.01)
A61B 17/064(2006.01)
(86)International application number:
PCT/US2015/056410
(87)International publication number:
WO 2016/073187 (12.05.2016 Gazette  2016/19)

(54)

INTRAVASCULAR DEVICE DELIVERY SYSTEM WITH A ONE-WAY ACTUATOR KNOB

SYSTEM ZUR FREISETZUNG EINER INTRAVASKULÄREN VORRICHTUNG MIT EINEM EINWEGAKTUATORKNOPF

SYSTÈME D'INTRODUCTION INTRAVASCULAIRE À BOUTON ACTIONNEUR UNIDIRECTIONNEL


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 04.11.2014 US 201414532494

(43)Date of publication of application:
13.09.2017 Bulletin 2017/37

(73)Proprietor: Abbott Cardiovascular Systems Inc.
Santa Clara, California 95054 (US)

(72)Inventors:
  • MARTIN, Jeffrey J.
    San Lorenzo, California 94580 (US)
  • LIM, Adrian M.
    Mountain View, California 94043 (US)
  • HOANG, Tin
    San Francisco, California 94122 (US)

(74)Representative: Boult Wade Tennant LLP 
Salisbury Square House 8 Salisbury Square
London EC4Y 8AP
London EC4Y 8AP (GB)


(56)References cited: : 
WO-A1-2011/082350
US-A1- 2011 208 169
WO-A1-2012/151543
  
  • "MitraClip Clip Delivery System IFU INSTRUCTIONS FOR USE MITRACLIP SYSTEM Steerable Guide Catheter Ref No. SGC01ST Clip Delivery System Ref No. CDS02ST MITRACLIP SYSTEM ACCESSORIES Stabilizer Ref No. SZR01ST Lift Ref No. LFT01ST Support Plate Ref No. PLT01ST", , 24 January 2014 (2014-01-24), XP055269141, fda.gov Retrieved from the Internet: URL:http://web.archive.org/web/20140124023 832/http://www.fda.gov/downloads/AdvisoryC ommittees/CommitteesMeetingMaterials/Medic alDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/UCM343688.pd f [retrieved on 2016-04-28] & wayback machine: "Proof of public availability of MitraClip IFU on fda.org", , 24 January 2014 (2014-01-24), XP055269137, Retrieved from the Internet: URL:http://web.archive.org/web/*/http://ww w.fda.gov/downloads/AdvisoryCommittees/Com mitteesMeetingMaterials/MedicalDevices/Med icalDevicesAdvisoryCommittee/Cir
  • "FDA premarket approval - MitraClip Clip delivery system", , 24 October 2013 (2013-10-24), XP055269173, fda.gov Retrieved from the Internet: URL:http://www.accessdata.fda.gov/cdrh_doc s/pdf10/p100009a.pdf [retrieved on 2016-04-28]
  • wikipedia.org: "Diving watch", , 25 September 2014 (2014-09-25), XP055269278, Retrieved from the Internet: URL:https://en.wikipedia.org/w/index.php?t itle=Diving_watch&oldid=627082924 [retrieved on 2016-04-28]
  • Norbert Leitgeb: "Safety of Electromedical Devices: Law - Risks - Opportunities", , 6 May 2010 (2010-05-06), pages 66-66, XP055269293, Springer Science & Business Media ISBN: 978-3-211-99682-9 Retrieved from the Internet: URL:https://books.google.de [retrieved on 2016-04-28]
  
Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


Description

BACKGROUND OF THE DISCLOSURE


1. The Field of the Invention



[0001] Generally, this disclosure relates to medical devices. Specifically, the present disclosure relates to intravascular devices. Even more specifically, the present disclosure relates to the reliable control and deployment of intravascular devices.

2. Background and Relevant Art



[0002] Intravascular devices grant medical professionals the ability and option to perform healing procedures within a patient while avoiding more complicated, higher risk, and more expensive invasion procedures. The ability to access, for example, the heart through the femoral artery allows a medical professional to avoid open surgery and can save the patient days or weeks of recovery time. Open surgery carries with it potential complications. Open surgery can be take more time, require more personnel, lead to greater blood loss, and carry a greater infection risk during the procedure.

[0003] Additionally, the recovery period for open surgery carries significant downsides, as well. Any surgical opening requires time to heal upon closure. The healing time is longer for a larger opening. Larger openings may also carry with them a greater risk of infection during the healing process. The larger surface area that may become infected is an additional challenge, but the longer time period also creates problems as patients typically become less vigilant about maintaining the sterility and cleanliness of their sutures, staples, or other closures as time progresses.

[0004] Because intravascular procedures carry benefits over open surgery, they are used in increasing numbers. Intravascular procedures are also used to provide care to patients who may not be optimal candidates for open surgeries due to age or other medical concerns. Therefore, access to a variety of procedures is desirable. Consequentially, intravascular procedures may include the insertion and subsequent removal of intravascular devices or may include the placement of a device to remain in the patient's body, either temporarily or permanently. Both the incorrect or incomplete placement of an intravascular device, as well as the premature deployment of an intravascular device can cause significant complications. Incorrect, incomplete, or premature deployment may dictate a subsequent open surgery to retrieve or repair the intravascular device and even in a patient previously determined to be a non-ideal candidate for open surgery.

[0005] In WO 2011/082350 there are described various surgical procedure systems, devices, tools, and methods, that are said to be useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to tissue, devices and tools for transvaginally accessing a posterior region of pelvic anatomy, devices (including certain types of implants, anchors, and tools) for connecting (e.g., adjustably) a vaginal apex to a region of sacral anatomy to provide support to the vaginal apex, and related methods.

[0006] In WO 2012/151543 there is described a tool for driving a helical anchor into a target location, the tool including a proximal portion and a distal portion, the proximal portion having a handle and an actuator, and a shaft extending distally from the proximal portion, the shaft comprising an outer shaft and an inner rotating shaft that is at least partially concentrically positioned within the outer shaft, the shaft having a length that facilitates accessing a location of a posterior pelvic region, wherein the inner rotating shaft is actuated by movement of the actuator in a predetermined motion.

[0007] In US 2011/0208169 there is described a device for the delivery of surgical fasteners. The device is said to improve the penetration of the fasteners and reduces the effort required for a surgeon to hold opposing pressure in order to deploy the fastener. The device comprises a lever in mechanical cooperation with a resilient element for storing energy; a drive mechanism which cooperates with at least one surgical fastener; and a release mechanism for rapidly releasing stored energy from the resilient element to the drive mechanism. In certain arrangements, at least partial depression of the lever stores energy in the resilient element while release of the lever from the at least partial depressed position does not release the stored energy from the resilient element. Additionally, the drive mechanism converts stored energy from the resilient element upon activation of the release mechanism to deliver the at least one surgical fastener.

BRIEF SUMMARY



[0008] Embodiments of the present disclosure address one or more of the foregoing or other problems in the art with apparatuses and systems for more reliably controlling and deploying intravascular devices.

[0009] According to the present invention there is provided an apparatus for controlling an intravascular device, the apparatus having the features of claim 1. In a non-limiting embodiment, the apparatus for controlling the intravascular device includes a body containing a rotating assembly configured to hold an end of an elongated mandrel. The rotating assembly is rotationally connected to the body by a one-way bearing located between the rotating assembly and the body. The rotating assembly is rotated by an actuator knob. The one-way bearing allows the transmission of a rotational force from the rotating assembly to the elongate mandrel in one direction. The one-way bearing prevents the transmission of a rotational force from the body to the elongate mandrel in an opposite rotational direction.

[0010] According to another aspect of the present invention there is provided a method of manufacturing an apparatus for controlling an intravascular device, the method having the features of claim 8. In another non-limiting embodiment, the method of manufacturing includes affixing an elongate mandrel within a rotating assembly. A one-way bearing is affixed inside a threaded insert. The threaded insert is threaded into a bore by applying torque in a locking direction of the one-way bearing. At least part of the rotating assembly is affixed within the one-way bearing.

[0011] According to another aspect of the present invention there is provided an intravascular device delivery system having the features of claim 15. In yet another non-limiting embodiment, the intravascular device delivery system includes an elongate mandrel with a proximal end and rotatable connector at a distal end. An intravascular device is fastened to the rotatable connector. The proximal end of the elongate mandrel is held by a rotating assembly in a controller. The controller includes a body in which the rotating assembly is located. An actuator knob is configured to rotate the rotating assembly relative to the body. The rotating assembly is connected to the body via a one-way bearing located between the rotating assembly and the body.

[0012] Additional features and advantages of embodiments of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such embodiments as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS



[0013] In order to describe the manner in which the above-recited and other advantages and features of the disclosure can be obtained, a more particular description of the disclosure briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. While some of the drawings are schematic representations, at least some of the figures may be drawn to scale. Understanding that these drawings depict only embodiments of the disclosure and are not therefore to be considered to be limiting of its scope, the disclosure will be described and explained with 5 additional specificity and detail through the use of the accompanying drawings in which:

Figure 1 illustrates an intravascular device delivery system according to the present disclosure;

Figure 2 illustrates a detail view of a controller including a one-way actuator knob;

Figure 3 illustrates a cross-sectional side view of a controller including a one-way actuator knob;

Figure 4 illustrates an exploded cross-sectional side view of an actuator slider and one-way actuator knob;

Figure 5 schematically illustrates a one-way actuator knob transferring torque to the body of the controller;

Figure 6 schematically illustrates a one-way actuator knob allowing rotation of the knob without transferring torque to the body of the controller;

Figure 7 illustrates a cross-sectional side view of a rotating assembly;

Figure 8 illustrates the mounting of a one-way bearing in a controller; and

Figure 9 illustrates the assembly of a controller according to the present disclosure.


DETAILED DESCRIPTION



[0014] One or more embodiments of the present disclosure relate to apparatuses for controlling and deploying intravascular devices.

[0015] An intravascular device may be controlled and deployed by a controller operated by a medical professional from outside the patient's vasculature. The controller may allow for the actuation of various components of the intravascular device and may allow the placement of the intravascular device. The placement of the device may include rotational and longitudinal placement in a vessel. Rotational placement may be effected by the translation of torque from the controller to the intravascular device. An elongate mandrel may connect the controller to the intravascular device and transmit longitudinal force and torque therebetween. The controller may include a rotatable actuator knob that may disconnect the intravascular device from the elongate mandrel.

[0016] The actuator knob may disconnect the intravascular device from the elongate mandrel when the actuator knob, and hence the elongate mandrel, is rotated in a counter clockwise direction. However, when rotated in the clockwise direction, the actuator knob, and hence the elongate mandrel, may damage the connection between the elongate mandrel and the intravascular device. A one-way bearing located between a body of the controller and a rotating assembly inside the controller may substantially limit the ability of the actuator knob to rotate in the clockwise direction and damage the connection between the elongate mandrel and the intravascular device. The one-way bearing may allow the rotation of the elongate mandrel without any perceivable interference to a user in a first direction. The one-way bearing may transmit torque from the actuator knob to the body of the controller, and hence the user's grip on the controller, when rotated in an opposite second direction. An incorrectly assembled controller may substantially inhibit counter clockwise rotation of the actuator knob and, hence, a medical professional's ability to disconnect and deploy an intravascular device. A method of manufacture is also presented herein to ensure correct directional assembly of a controller.

[0017] Figure 1 depicts an intravascular device delivery system 100 including a controller 102, an elongate mandrel 104, and an intravascular device 106. The controller 102 may be connected to a proximal end of the elongate mandrel 104 and the intravascular device 106 may be connected to a distal end of the elongate mandrel 104. The intravascular device 106 may include a variety of devices and is depicted schematically. In some embodiments, the intravascular device 106 may include a mitral valve repair device, such as a MITRACLIP available from Abbott Vascular. In other embodiments, the intravascular device 106 may include other vascular repair devices. In yet other embodiments, the intravascular device 106 may include filtration devices. In further embodiments, the intravascular device 106 may include pharmaceutical eluting devices. In some embodiments, the elongate mandrel 104 may connect to the intravascular device 106 by an internal threaded connection, an external threaded connection, a bayonet connection, other suitable rotational connection, or combinations thereof.

[0018] The elongate mandrel 104 may include a catheter, guidewire, other vascular sleeve, or combinations thereof. In some embodiments, the elongate mandrel 104 may have a working length less than about 1000mm in length, greater than about 1000mm in length, greater than about 1200mm in length, or about 1220mm in length. As used herein, "working length" should be understood to be the effective, usable length of a component or device during a medical procedure. For example, the total length of the elongate mandrel 104 may be greater than the working length of the elongate mandrel 104 as portions of the elongate mandrel may be contained within other components, such as the intravascular device 106 or the controller 102.

[0019] The controller 102 is located at a proximal end of the elongate mandrel 104. The controller 102 may include a variety of buttons 108 in order to control various functions or conditions of the intravascular device 106, pressure system (e.g. a bleedback valve) and/or a delivery mechanism. In the depicted embodiment, the controller 102 may include an arm positioner knob 110 for manipulating the arm positions of a mitral valve repair device. Actuator knob 112 is located at the proximal end of the controller 102. The rotation of the actuation knob 112 may be restricted by an actuator clip 114. The actuator clip 114 rotationally fixes a position of the actuator knob 112 relative to a controller body 116. The actuator clip 114 may be removed when rotation of the actuator knob 112, hence deployment of the intravascular device 106 is intended.

[0020] Figure 2 illustrates a detail view of the controller 102 and actuator knob 112 with the actuator clip 114 removed. The actuator knob 112 may be fixed to a threaded rod 118 that is inserted and threaded into a crimping cam 120 (visible in Figure 3). The actuator knob 112 may thereby rotate the crimping cam 120 via torque transmitted by the threaded rod 118. The crimping cam 120 may rotate relative to the controller body 116 when the actuator clip 114 is removed from the crimping cam 120.

[0021] Figure 3 shows a cross-sectional view of the controller 102 depicted in Figure 2. As described, the actuator knob 112 may be fixed to a threaded rod 118, which is threaded into the crimping cam 120. The crimping cam 120 may include within it a collet 122. In some embodiments, the crimping cam 120 may be generally cylindrical, for example, having a circular transverse cross-section. In other embodiments, the interior surface 124 of the crimping cam 120 may have a polygonal transverse cross-section such a square, a pentagon, a hexagon, and similar or an irregular polygon. Similarly, in some embodiments, the collet 122 may be generally cylindrical and have a circular transverse cross-section. In other embodiments, the collet 122 may have a polygonal transverse cross-section such a square, a pentagon, a hexagon, and similar or an irregular polygon. In some embodiments, the collet 122 may mate complimentarily with an interior surface 124 of the crimping cam 120.

[0022] The actuator knob 112, threaded rod 118, crimping cam 120, collet 122 may share a longitudinal axis 126 about which they may all rotate. As such, the shared longitudinal axis 126 may also be a shared rotational axis. The threaded rod 118 may apply a longitudinal compression force upon the collet 122 as the threaded rod 118 is rotated against the complimentarily threaded crimping cam 120. The compression force on the collet 122 may cause the collet to move longitudinally and strike one or more tapers 128 on the crimping cam 120. The tapers 128 may apply a lateral compression force upon the collet 122. The lateral compression force may, in turn, cause the collet 122 to impinge upon a proximal end 130 of the elongate mandrel 104.

[0023] The collet 122 may thereby hold the proximal end 130 of the elongate mandrel 104 within the rotating assembly 132. The rotating assembly 132 may include the actuator knob 112, threaded rod 118, collet 122, and crimping cam 120. The rotating assembly 132 may rotate relative to the controller body 116. In some embodiments, the rotating assembly 132 may rotate upon a one-way bearing 134 located between the rotating assembly 132 and an actuator slider 136. The actuator slider 136 may be rotationally fixed relative to the controller body 116. In other embodiments, the rotating assembly 132 may rotate upon a one-way bearing 134 located between the rotating assembly 132 and the controller body 116.

[0024] In some embodiments, the one-way bearing 134 may be a rotational clutch bearing. In other embodiments, the one-way bearing 134 may be a ratcheting bearing. In an embodiment, the one-way bearing 134 may be an annular or cylindrical rotational bearing. The rotating assembly 132 may be rotationally fixed relative an inner surface of the one-way bearing. In various embodiments, the rotating assembly 132 and one-way bearing 134 are fixed using a friction fit, a press fit, an adhesive, a weld, another suitable attachment mechanism, or combinations thereof. A clutch bearing may freely enable rotation of the rotating assembly 132 in a first direction while allowing for nearly instant resistance to be applied when rotated in a second direction. Similarly, a ratcheting bearing may freely enable rotation in the first direction, but may allow some degree of backlash in the second direction. As used herein, "rotating direction" should be understood to refer to the rotational direction in which the one-way bearing 134 rotates with relatively little friction. "Locking direction" should be understood to refer to the rotational direction in which the one-way bearing 134 may resist rotation and transfer torque. The ratcheting bearing may result in a tactile "clicking" sensation during operation. In some environments, such a sensation may be undesirable due to the medical professional's experience and training with other rotation systems. When changing from a rotation system such as a bi-direction actuator having a rotating inner component and a stationary outer component separated only by a simple bearing surface, the change from a simple bearing surface with near constant friction to a ratcheting system may result in a foreign tactile sensation. In at least some embodiments therefore, it may be desirable to retain as much familiar tactile performance as possible to encourage adoption of embodiments incorporating a one-way bearing 134.

[0025] The one-way bearing 134 may rotate freely in the "rotating direction" and "lock" when torque is applied in the "locking direction." To help ensure the one-way bearing 134 is installed in the controller 102 in the proper orientation, a number of indicators and design structures may be employed. In an embodiment, the one-way bearing may have a visual indicator imprinted, embossed, and/or applied to a surface indicating the rotating direction. In another embodiment, the locking direction may be leveraged during the assembly process. Figure 4 depicts a controller 102 expanded along the longitudinal axis 126. The one-way bearing 134 is connected to the interior of a threaded insert 138. The one-way bearing 134 may be connected to the interior of a threaded insert 138 by a friction fit, a press fit, an adhesive, a weld, another suitable attachment mechanism, or combinations thereof.

[0026] The threaded insert 138 may use the locking direction of the affixed one-way bearing 134 to drive the threaded insert 138 into the actuator slider 136. The threaded insert 138 may include left-hand threads 140 (opposite of the common threading direction) on a lateral surface thereof, which may mate with complimentary threads 142 on the actuator slider 136. The locking direction of the one-way bearing 134 may therefore transfer torque to the threaded insert 138 when the one-way bearing 134 is aligned such that the locking direction is oriented in the direction of the left-hand threads 140. The rotating direction of the one-way bearing 134 may also substantially prevent the transfer of torque to the threaded insert 138 when the one-way bearing 134 is aligned such that the rotating direction is oriented in the direction of the left-hand threads 140.

[0027] The threaded insert 138 may be driven into the actuator slider 136 therefore when the locking direction of the one-way bearing 134 is oriented counter-clockwise when viewed from a distal end 144 of the controller 102. When viewed from a proximal end 146 of the controller 102, the locking direction of the one-way bearing 134 may be the clockwise direction. Accordingly, the rotating direction of the one-way bearing 134 may permit rotation in the counter-clockwise direction when viewed from the proximal end 146 of the controller 102. As an operator will view the controller 102 from the proximal end 146, the one-way bearing 134 may allow rotation of the actuator knob 112, and hence rotating assembly 132 and elongate mandrel 104 in a counter-clockwise direction. The counter-clockwise rotation of the elongate mandrel 104 may disconnect and/or deploy the intravascular device 106 at the distal end of the elongate mandrel 104.

[0028] As shown in Figure 5, applying torque to the actuator knob 112 may apply a torque to the rotating assembly 132. When the torque vector is in the distal direction (according to the right-hand rule) toward the distal end 144 of the controller 102, the one-way bearing 134 may transmit the torque to act upon the actuator slider 136. The actuator slider 136 may be rotationally fixed to the controller body 116. The controller body 116 may be held by a user during operation of the actuator knob 112. The actuator knob 112 may have a smaller radius than the controller body 116. Therefore, the user may use comparatively little force to hold the controller body 116 still during the transmission of torque from the actuator knob 112 to the controller body 116. This may effectively prevent substantial movement of the controller 102 during application of torque to the actuator knob 112 in the locking direction.

[0029] As shown in Figure 6, applying torque to the actuator knob 112 toward the proximal end 146 (according to the right-hand rule) may apply torque to the rotating assembly 132. The one-way bearing 134 may transmit little to no torque to the controller body 116 through the threaded insert 138, thereby allowing rotation of the rotating assembly 132 about the longitudinal axis 126. The rotation of the rotating assembly 132 about the longitudinal axis may rotate the elongate mandrel 104.

[0030] The rotating assembly 132 may be connected via the one-way bearing to the controller body 116 directly or via the actuator slider 136. The rotating assembly 132 may be "held" in place when the one-way bearing 134 transfers torque to the actuator slider 136, which may be, in turn, held in place by the body 116. An operator may then resist the rotation of the body manually. The rotating assembly 132 may also be connected to the controller body 116 directly via the one-way bearing 134, such that the one-way bearing 134 transfers torque directly from the rotating assembly 132 to the controller body 116.

[0031] As described in relation to Figure 3, the intravascular device delivery system 100 of the present disclosure may use the mechanical characteristics of some components during a manufacturing process. As shown in Figure 7, the assembly of an intravascular device delivery system 100 may include the assembly of a controller 102. The elongate mandrel 104 may be inserted into the collet 122. The elongate mandrel 104 may extend from a tapered end 148 of the collet 122 and the proximal end 130 of the elongate mandrel 104 may be within the collet 122. The collet 122 may be inserted into the crimping cam 120. In an embodiment, the crimping cam 120 may include one or more tapers 128 that compliment tapers 150 on the collet 122. In other embodiments, the crimping cam 120 may include one or more tapers 128 that do not compliment tapers 150 on the collet 122. The crimping cam 120 may have a decreasing inner radius that applies a compressive force to the collet 122 as the collet 122 moves proximally within the crimping cam 120. While Figure 7 depicts an embodiment of a crimping cam 120 having tapers 150, the depicted profile should be understood to be a non-limiting example of a crimping cam design.

[0032] The collet 122 may be retained within the crimping cam 120 by the threaded rod 118. When threaded through the complimentary threads on the crimping cam 120, the threaded rod 118 may apply a longitudinal compressive force on the collet 122. The crimping cam 120, collet 122, actuator knob 112, and threaded rod 118 form the rotating assembly 132 and define the rotational component within the actuator slider 136 and the controller body 116.

[0033] Figure 8 depicts the assembly of the controller body 116, actuator slider 136, threaded insert 138, and one-way bearing 134. In an embodiment, the assembly process may include attaching the one-way bearing 134 to the interior of the threaded insert 138. The one-way bearing 134 may include indicia (not shown) that indicate the rotating direction and locking direction. In some embodiments, the threaded insert 138 may include a slight taper on the interior diameter 158 such that the one-way bearing 134 may be inserted into the threaded insert from the proximal end of the threaded insert 160 (the end opposing the flange 154) such that the one-way bearing 134 can only be inserted into the threaded insert 138 before the threaded insert 138 is inserted into the actuator slider 136. The threaded insert 138 may include left-hand threads 140 and a flange 154 that complimentarily mate with the complimentary threads 142 and a notch 156 on the actuator slider 136. The threaded insert 138 may, therefore, fit in the actuator slider 136 in one direction. The threaded insert 138 may then be driven into the actuator slider 136 along the left-hand threads 140 and complimentary threads 142 by applying torque to the one-way bearing 134 and rotating the one-way bearing 134 in the locking direction.

[0034] If the one-way bearing 134 is oriented correctly in the threaded insert 138, and the threaded insert 138 is aligned correctly with the actuator slider 136, the threaded insert 138 will drive into the actuator slider 136 and affix the one-way bearing 134 to the actuator slider 136 in the desired orientation. If the one-way bearing 134 is oriented incorrectly in the threaded insert 138, the application of torque to the one-way bearing 134 will result in the one-way bearing 134 rotating in the rotating direction and fail to transfer any torque to drive the threaded insert 138 into the actuator slider 136. The actuator slider 136 may have a bore 152 extending therethrough, into which the rotating assembly 132 may fit.

[0035] Figure 9 shows a schematic representation of the rotating assembly 132 being inserted into the one-way bearing 134 that has been affixed to the actuator slider 136 according to the method described in relation to Figure 8. The rotating assembly 132 may be connected to the interior of the one-way bearing 134 using a friction fit, a press fit, an adhesive, a weld, another suitable attachment mechanism, or combinations thereof, as described in relation to Figure 3. The rotating assembly 132 may be contained within a bore 152 that extends through the actuator slider 136. The rotating assembly 132 may contact the wall of the bore 152. In an embodiment, the controller 102 may include a layer of boundary material 162 between the rotating assembly 132 and the wall of the bore 152.

[0036] In some embodiments, the boundary material 162 may be made of or include a low-friction and/or lubricious material. For example, the boundary material 162 may be made of or include polyoxymethylene, polytetraflouroethylene, or similar materials. In other embodiments, the boundary material 162 may be a low-wear, high durability coating. In some embodiments, the boundary material 162 may include a coating on the rotating assembly 132, a coating on the wall of the bore 152, integral to the rotating assembly 132, integral to the wall of the bore 152, or combinations thereof. Additionally, the boundary material 162 may be a discrete component providing a substantially circumferential boundary around the rotating assembly 132. In an embodiment, the boundary material 162 may be a continuous layer. For example, the boundary material 162 may cover the entirety of the surface, longitudinally and/or circumferentially around the rotating assembly 132. In another embodiment, the boundary material 162 may include a non-continuous and/or intermittent distribution that provides a set space between the rotating assembly 132 and the wall of the bore 152. For example, the boundary material 162 may include a plurality of circumferential strips that are spaced along the longitudinal length of the rotating assembly 132. In another example, the boundary material 162 may include a plurality of longitudinal strips that are spaced along the circumference of the rotating assembly 132.

[0037] The terms "approximately," "about," and "substantially" as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount.

[0038] In the description herein, various relational terms are provided to facilitate an understanding of various aspects of some embodiments of the present disclosure. Relational terms such as "bottom," "below," "top," "above," "back," "front," "left," "right," "rear," "forward," "up," "down," "horizontal," "vertical," "clockwise," "counterclockwise," "upper," "lower," and the like, may be used to describe various components, including their operation and/or illustrated position relative to one or more other components. For example, "proximal" and "distal" may indicate position and direction relative to the operator during use of the intravascular delivery system. Relational terms do not indicate a particular orientation for each embodiment within the scope of the description or claims. Accordingly, relational descriptions are intended solely for convenience in facilitating reference to various components, but such relational aspects may be reversed, flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified unless otherwise specified. Certain descriptions or designations of components as "first," "second," "third," and the like may also be used to differentiate between identical components or between components which are similar in use, structure, or operation. Such language is not intended to limit a component to a singular designation. As such, a component referenced in the specification as the "first" component may be the same or different than a component that is referenced in the claims as a "first" component.

[0039] Furthermore, while the description or claims may refer to "an additional" or "other" element, feature, aspect, component, or the like, it does not preclude there being a single element, or more than one, of the additional element. Where the claims or description refer to "a" or "an" element, such reference is not be construed that there is just one of that element, but is instead to be inclusive of other components and understood as "at least one" of the element. It is to be understood that where the specification states that a component, feature, structure, function, or characteristic "may," "might," "can," or "could" be included, that particular component, feature, structure, or characteristic is provided in some embodiments, but is optional for other embodiments of the present disclosure. The terms "couple," "coupled," "connect," "connection," "connected," "in connection with," and "connecting" refer to "in direct connection with," or "in connection with via one or more intermediate elements or members." Components that are "integral" or "integrally" formed include components made from the same piece of material, or sets of materials, such as by being commonly molded or cast from the same material, or commonly machined from the same piece of material stock. Components that are "integral" should also be understood to be "coupled" together.

[0040] Although various example embodiments have been described in detail herein, those skilled in the art will readily appreciate in view of the present disclosure that many modifications are possible in the example embodiments without materially departing from the present disclosure. Accordingly, any such modifications are intended to be included in the scope of this disclosure. Likewise, while the disclosure herein contains many specifics, these specifics should not be construed as limiting the scope of the disclosure or of any of the appended claims, but merely as providing information pertinent to one or more specific embodiments that may fall within the scope of the disclosure and the appended claims. Any described features or elements from the various embodiments disclosed may be employed in combination with any other features or elements disclosed herein.

[0041] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the scope of the present disclosure. Equivalent constructions, including functional "means-plus-function" clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words 'means for' appear together with an associated function.


Claims

1. An apparatus (102) for controlling an intravascular device (106), the apparatus (102) comprising:

a body (116);

an elongate rotatable mandrel (104) having a proximal end and a distal end, the elongate rotatable mandrel (104) having a connector at the distal end to connect to the intravascular device;

a rotating assembly (132) configured to hold the proximal end of the elongate mandrel (104), the rotating assembly (132) disposed within the body (116);

an actuator knob (112) configured to rotate the rotating assembly (132); and

a one-way bearing (134) disposed circumferentially between at least part of the rotating assembly (132) and the body (116) that allows transmission of a first rotational force from the rotating assembly (132) to the elongate mandrel (104) in one rotational direction while preventing the transmission of a second rotational force from the body (116) to the elongate mandrel (104) in an opposite rotational direction,

characterized in that the one-way bearing (134) is affixed within a threaded insert (138), and

the threaded insert (138) is threaded into a bore (152) of the apparatus, such that the threaded insert (138) is driven into the bore (152) by applying a torque to the one-way bearing (134) in said opposite rotational direction.


 
2. The apparatus (102) of claim 1, wherein the threaded insert (138) has left-hand threads (140).
 
3. The apparatus (102) of claim 1, wherein the one-way bearing (134) is a clutch bearing.
 
4. The apparatus (102) of claim 1, further comprising a locking pin configured to rotationally fix the rotating assembly (132) relative to the body (116).
 
5. The apparatus (102) of claim 1, wherein the rotating assembly (132) is configured to hold the proximal end of the elongate mandrel (104) using a collet (122).
 
6. The apparatus (102) of claim 1, wherein the one-way bearing (134) is configured to transfer torque from the rotating assembly (132) to the body (116) when the torque has a vector substantially oriented towards the distal end of the elongate mandrel (104).
 
7. The apparatus (102) of claim 1, wherein the threaded insert (138) comprises a flange (154).
 
8. A method of manufacturing an apparatus (102) for controlling an intravascular device (106), the method comprising:

affixing an elongate mandrel (104) within a rotating assembly (132), the elongate mandrel (104) having a proximal end and a distal end comprising a connector for connecting to the intravascular device;

affixing a one-way bearing (134) within a threaded insert (138), the one-way bearing (134) having a rotating direction and a locking direction;

threading the threaded insert (138) into a bore (152) of the apparatus, the threaded insert (138) being driven into the bore (152) by applying a torque to the one-way bearing (134) in the locking direction; and

affixing at least part of the rotating assembly (132) within the one-way bearing (134).


 
9. The method of claim 8, wherein the threaded insert (138) includes left-hand threads (140).
 
10. The method of claim 8, wherein the threaded insert (138) comprises a tapered inner diameter (158) configured to receive the one-way bearing (134) in a press fit from only one direction.
 
11. The method of claim 8, wherein affixing the elongate mandrel (104) within the rotating assembly (132) includes compressing the elongate mandrel (104) within a collet (122).
 
12. The method of claim 8, further comprising connecting an intravascular device (106) to the distal end of the elongate mandrel (104) using a rotatable connection.
 
13. The method of claim 8, wherein affixing the one-way bearing (134) within the threaded insert (138) includes press fitting the one-way bearing (134) within the threaded insert (138).
 
14. The method of claim 8, wherein threading the threaded insert (138) into the bore (152) further comprises aligning a flange (154) on the threaded insert (138) with a notch (156) at an end of the bore (152).
 
15. An intravascular device delivery system (100) comprising the apparatus of any of claims 1 to 7 and having an intravascular device (106) fastened to the rotatable connection at the distal end of the elongate mandrel.
 
16. The system (100) of claim 15, wherein the intravascular device (106) is a mitral valve repair device.
 


Ansprüche

1. Apparat (102) zum Steuern einer intravaskulären Vorrichtung (106), wobei der Apparat (102) umfasst:

einen Körper (116);

einen langgestreckten drehbaren Dorn (104) mit einem proximalen Ende und einem distalen Ende, wobei der langgestreckte drehbare Dorn (104) an dem distalen Ende einen Verbinder zum Verbinden mit der intravaskulären Vorrichtung aufweist;

eine rotierende Baugruppe (132), die konfiguriert ist, um das proximale Ende des langgestreckten Dorns (104) zu halten, wobei die rotierende Baugruppe (132) innerhalb des Körpers (116) angeordnet ist;

einen Betätigungsknopf (112), der konfiguriert ist, um die rotierende Baugruppe (132) zu drehen; und

ein Freilauflager (134), das in Umfangsrichtung zwischen mindestens einem Teil der rotierenden Baugruppe (132) und dem Körper (116) angeordnet ist und die Übertragung einer ersten Drehkraft von der rotierenden Baugruppe (132) auf den langgestreckten Dorn (104) in einer Drehrichtung ermöglicht und dabei die Übertragung einer zweiten Drehkraft von dem Körper (116) auf den langgestreckten Dorn (104) in einer entgegengesetzten Drehrichtung verhindert,

dadurch gekennzeichnet, dass das Freilauflager (134) innerhalb eines Gewindeeinsatzes (138) befestigt ist, und

der Gewindeeinsatz (138) in eine Bohrung (152) der Vorrichtung geschraubt ist, so dass der Gewindeeinsatz (138) in die Bohrung (152) getrieben wird, indem ein Drehmoment auf das Freilauflager (134) in der genannten entgegengesetzten Drehrichtung ausgeübt wird.


 
2. Apparat (102) nach Anspruch 1, bei dem der Gewindeeinsatz (138) ein Linksgewinde (140) aufweist.
 
3. Apparat (102) nach Anspruch 1, bei dem das Freilauflager (134) ein Kupplungslager ist.
 
4. Apparat (102) nach Anspruch 1, ferner mit einem Verriegelungsstift, der konfiguriert ist, um die rotierende Baugruppe (132) relativ zum Körper (116) drehfest zu fixieren.
 
5. Apparat (102) nach Anspruch 1, bei dem die rotierende Baugruppe (132) konfiguriert ist, um das proximale Ende des langgestreckten Dorns (104) unter Verwendung einer Spannzange (122) zu halten.
 
6. Apparat (102) nach Anspruch 1, bei dem das Freilauflager (134) konfiguriert ist, um Drehmoment von der rotierenden Baugruppe (132) auf den Körper (116) zu übertragen, wenn das Drehmoment einen Vektor hat, der im Wesentlichen auf das distale Ende des länglichen Dorns (104) ausgerichtet ist.
 
7. Apparat (102) nach Anspruch 1, bei dem der Gewindeeinsatz (138) einen Flansch (154) umfasst.
 
8. Verfahren zum Herstellen eines Apparates (102) zum Steuern einer intravaskulären Vorrichtung (106), wobei das Verfahren umfasst:

Befestigen eines langgestreckten Dorns (104) innerhalb einer rotierenden Baugruppe (132), wobei der langgestreckte Dorn (104) ein proximales Ende und ein distales Ende mit einem Verbinder zum Verbinden mit der intravaskulären Vorrichtung aufweist;

Befestigen eines Freilauflagers (134) innerhalb eines Gewindeeinsatzes (138), wobei das Freilauflager (134) eine Drehrichtung und eine Sperrrichtung aufweist;

Einschrauben des Gewindeeinsatzes (138) in eine Bohrung (152) der Vorrichtung, wobei der Gewindeeinsatz (138) durch Aufbringen eines Drehmoments auf das Freilauflager (134) in Verriegelungsrichtung in die Bohrung (152) getrieben wird; und

Befestigen zumindest eines Teils der rotierenden Baugruppe (132) innerhalb des Freilauflagers (134).


 
9. Verfahren nach Anspruch 8, bei dem der Gewindeeinsatz (138) ein Linksgewinde (140) aufweist.
 
10. Verfahren nach Anspruch 8, bei dem der Gewindeeinsatz (138) einen kegelförmigen Innendurchmesser (158) aufweist, der konfiguriert ist, das Freilauflager (134) in einer Presspassung aus nur einer Richtung aufzunehmen.
 
11. Verfahren nach Anspruch 8, bei dem das Befestigen des langgestreckten Dorns (104) innerhalb der rotierenden Baugruppe (132) das Zusammendrücken des langgestreckten Dorns (104) mit einer Spannzange (122) umfasst.
 
12. Verfahren nach Anspruch 8, das ferner das Verbinden einer intravaskulären Vorrichtung (106) mit dem distalen Ende des langgestreckten Dorns (104) unter Verwendung einer drehbaren Verbindung umfasst.
 
13. Verfahren nach Anspruch 8, bei dem das Befestigen des Freilauflagers (134) innerhalb des Gewindeeinsatzes (138) ein Presspassen des Freilauflagers (134) innerhalb des Gewindeeinsatzes (138) umfasst.
 
14. Verfahren nach Anspruch 8, bei dem das Einschrauben des Gewindeeinsatzes (138) in die Bohrung (152) ferner das Ausrichten eines Flansches (154) an dem Gewindeeinsatz (138) auf eine Kerbe (156) an einem Ende der Bohrung (152) umfasst.
 
15. System (100) zur Freisetzung einer intravaskulären Vorrichtung, das die Vorrichtung nach einem der Ansprüche 1 bis 7 umfasst und bei dem eine intravaskuläre Vorrichtung (106) an der drehbaren Verbindung am distalen Ende des langgestreckten Dorns befestigt ist.
 
16. System (100) nach Anspruch 15, bei dem die intravaskuläre Vorrichtung (106) eine Mitralklappenreparaturvorrichtung ist.
 


Revendications

1. Appareil (102) pour commander un dispositif intravasculaire (106), l'appareil (102) comprenant :

un corps (116) ;

un mandrin rotatif allongé (104) ayant une extrémité proximale et une extrémité distale, le mandrin rotatif allongé (104) ayant un raccord au niveau de l'extrémité distale pour se raccorder au dispositif intravasculaire ;

un ensemble tournant (132) configuré pour maintenir l'extrémité proximale du mandrin allongé (104), l'ensemble tournant (132) étant disposé dans le corps (116) ;

un bouton d'actionnement (112) configuré pour faire tourner l'ensemble tournant (132) ; et

un palier unidirectionnel (134) disposé de manière circonférentielle entre au moins une partie de l'ensemble tournant (132) et le corps (116) qui permet la transmission d'une première force de rotation de l'ensemble tournant (132) au mandrin allongé (104) dans une direction de rotation tout en empêchant la transmission d'une deuxième force de rotation du corps (116) au mandrin allongé (104) dans une direction de rotation opposée,

caractérisé en ce que le palier unidirectionnel (134) est fixé dans un insert fileté (138), et

l'insert fileté (138) est fileté dans un alésage (152) de l'appareil, de sorte que l'insert fileté (138) soit entraîné dans l'alésage (152) en appliquant un couple au palier unidirectionnel (134) dans ladite direction de rotation opposée.


 
2. Appareil (102) de la revendication 1, dans lequel l'insert fileté (138) a un filetage à gauche (140).
 
3. Appareil (102) de la revendication 1, dans lequel le palier unidirectionnel (134) est un palier d'embrayage.
 
4. Appareil (102) de la revendication 1, comprenant en outre une goupille de verrouillage configurée pour fixer en rotation l'ensemble tournant (132) par rapport au corps (116) .
 
5. Appareil (102) de la revendication 1, dans lequel l'ensemble tournant (132) est configuré pour maintenir l'extrémité proximale du mandrin allongé (104) en utilisant une pince de serrage (122).
 
6. Appareil (102) de la revendication 1, dans lequel le palier unidirectionnel (134) est configuré pour transférer un couple de l'ensemble tournant (132) au corps (116) lorsque le couple a un vecteur essentiellement orienté vers l'extrémité distale du mandrin allongé (104).
 
7. Appareil (102) de la revendication 1, dans lequel l'insert fileté (138) comprend une bride (154).
 
8. Procédé de fabrication d'un appareil (102) pour commander un dispositif intravasculaire (106), le procédé comprenant les étapes consistant à :

fixer un mandrin allongé (104) dans un ensemble tournant (132), le mandrin allongé (104) ayant une extrémité proximale et une extrémité distale comprenant un raccord pour se raccorder au dispositif intravasculaire ;

fixer un palier unidirectionnel (134) dans un insert fileté (138), le palier unidirectionnel (134) ayant une direction de rotation et une direction de verrouillage ;

fileter l'insert fileté (138) dans un alésage (152) de l'appareil, l'insert fileté (138) étant entraîné dans l'alésage (152) en appliquant un couple au palier unidirectionnel (134) dans la direction de verrouillage ; et

fixer au moins une partie de l'ensemble tournant (132) dans le palier unidirectionnel (134).


 
9. Procédé de la revendication 8, dans lequel l'insert fileté (138) comporte un filetage à gauche (140).
 
10. Procédé de la revendication 8, dans lequel l'insert fileté (138) comprend un diamètre interne effilé (158) configuré pour recevoir le palier unidirectionnel (134) par un ajustement serré à partir d'une seule direction.
 
11. Procédé de la revendication 8, dans lequel la fixation du mandrin allongé (104) dans l'ensemble tournant (132) comporte la compression du mandrin allongé (104) dans une pince de serrage (122).
 
12. Procédé de la revendication 8, comprenant en outre l'étape consistant à raccorder un dispositif intravasculaire (106) à l'extrémité distale du mandrin allongé (104) en utilisant un raccord rotatif.
 
13. Procédé de la revendication 8, dans lequel la fixation du palier unidirectionnel (134) dans l'insert fileté (138) comporte l'ajustement serré du palier unidirectionnel (134) dans l'insert fileté (138).
 
14. Procédé de la revendication 8, dans lequel le filetage de l'insert fileté (138) dans l'alésage (152) comprend en outre l'alignement d'une bride (154) sur l'insert fileté (138) avec une encoche (156) au niveau d'une extrémité de l'alésage (152).
 
15. Système de pose de dispositif intravasculaire (100) comprenant l'appareil de l'une quelconque des revendications 1 à 7 et ayant un dispositif intravasculaire (106) attaché au raccord rotatif au niveau de l'extrémité distale du mandrin allongé.
 
16. Système (100) de la revendication 15, dans lequel le dispositif intravasculaire (106) est un dispositif de réparation de valvule mitrale.
 




Drawing
































Cited references

REFERENCES CITED IN THE DESCRIPTION



This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description