Auxiliary device for separating an implant

By designing a retraction system for intravascular implants, the system uses a combination of sliding shuttles and fixtures to achieve tapering recovery of pull wires, solving the problem of complications during mechanical deployment and improving the accuracy and reliability of deployment.

CN111529153BActive Publication Date: 2025-06-17DEPUY SYNTHES PROD INC
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Patent Information

Application Number
CN202010082359.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-02-07
Filing Date
2020-02-07
Publication Date
2025-06-17
Estimated Expiration
2040-02-07

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Abstract

The present invention is titled "Auxiliary device for separating an implant". By using a retraction system, a pulling wire can be retracted from a catheter. The retraction system has: an opening sized to pass through the pulling wire and engage the catheter; two clamps positioned around the pulling wire; a shuttle on which the clamps are mounted; and a slider having at least one contact member for contacting and moving one or both of the clamps. To retract the pulling wire, the slider can move proximally, the contact member can engage one or both of the clamps on the shuttle, the clamps can move so that the clamps contact each other and grip the pulling wire, and then the slider can be further moved proximally to translate the shuttle, the clamps, and the pulling wire proximally to withdraw the pulling wire from the catheter. Subsequently, the shuttle and the slider can be moved distally without translating the pulling wire.
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Description

Technical Field

[0001] The present invention generally relates to medical devices and, more particularly, to deploying endoluminal implants. Background Art

[0002] Many intravascular implant devices and clot capture devices are known in the art. Many devices are mechanically deployed and manipulated via a system that combines one or more catheters and wires for delivery. Examples of mechanically deliverable implants include embolization elements, stents, grafts, drug delivery implants, flow diversion elements, filters, stimulation leads, sensing leads, or other implantable structures delivered via a microcatheter. Some obstetric and gastrointestinal implants can also be implanted via a similar system that combines one or more catheters and wires. Devices that can be released, deployed, or otherwise manipulated by mechanical means vary significantly in design but can employ similar delivery catheter and wire systems.

[0003] Many such catheter-based delivery systems include a catheter and an internal elongate member such as an internal catheter or wire that are configured to hold an implant within the catheter prior to release of the implant. These systems can be actuated by retracting or pulling one or more of the internal elongate members relative to the catheter. Such wires or internal elongate members are referred to herein as "pull wires." Precise deployment of the implant is critical to the successful treatment of vascular and endoluminal abnormalities. For some applications, complications can occur if the pull wire is pulled proximally and then pushed distally. The object of the present invention is to provide systems, devices, and methods for reducing such complications in such applications. Summary of the Invention

[0004] Exemplary systems and methods for retracting a pull wire from a mechanical intravascular implant device can address the above needs. In some examples, a retraction system can be utilized to retract the pull wire from the catheter, the retraction system having two clamps mounted to a sliding shuttle and a slider having at least one contact member for contacting and moving one or both of the two clamps. The pull wire can be positioned between the gripping regions on the two clamps when the clamps are in the open position. Then, when the slider is moved proximally, the contact member on the slider can engage one or both of the clamps on the shuttle, thereby causing at least one of the clamps to move such that the gripping regions come into contact and grip the pull wire. The slider can then be moved further proximally to translate the sliding shuttle, the clamps, and the pull wire proximally. The retraction system can have a tapered opening through which the pull wire can freely pass but the catheter cannot, such that when the pull wire is pulled proximally, the catheter is held in place.

[0005] An exemplary retraction system for retracting an inner elongate member of an implant delivery system from a catheter can have a first clamp, a second clamp, a shuttle on which the clamps are mounted, a contact member, and a slider on which the contact member is mounted. The shuttle and the slider can each be translated in a proximal direction and a distal direction. The retraction system can be configured such that a first translation of the slider in the proximal direction causes the first contact member to translate proximally to apply a first force from the first contact member to the first clamp, the first force causing the first clamp to move to move the clamp from an open position to a closed position. The first clamp can have a first gripping region, and the second clamp can have a second gripping region. In the open position, the first gripping region and the second gripping region can be positioned to allow the inner elongate member of the implant delivery system to pass through. In the closed position, the first gripping region and the second gripping region can be positioned to engage the inner elongate member. The retraction system can be configured such that a second translation of the slider in the proximal direction can cause the first clamping arm and the second clamping arm to translate proximally to retract the inner elongate member proximally from the catheter of the implant delivery system while the catheter is held in place by the retraction system.

[0006] The slider of the retraction system can include a second contact member. The retraction system can be configured such that a first translation of the slider causes the first contact member and the second contact member to translate proximally to apply a second force from the second contact member to the second clamp, the second force causing the second clamp to move from an open position to a closed position. The first force and the second force can be applied to the clamp simultaneously to cause the clamp to move from the open position to the closed position cooperatively.

[0007] The retraction system can include a housing sized to be handheld, and the shuttle and the slider are slidably mounted to the housing.

[0008] The retraction system can include a distal mounting block, a proximal mounting block, and a guide rail extending between the distal mounting block and the proximal mounting block. The shuttle and the slider can each be slidably mounted on the guide rail. The distal mounting block and the proximal mounting block can be mounted to a flat surface, mountable or positionable on a patient, and / or mountable within a handheld retractor. The distal mounting block can have a first opening for receiving the implant delivery system. The first opening can be incorporated within the housing of the handheld retractor. The size of the first opening can be configured to prevent the catheter from moving proximally and to allow the inner elongate member to pass through.

[0009] The retraction system can include a return spring positioned to apply a return spring force between the slider and the distal mounting block. The return spring force can be sufficient to cause the slider to move in the distal direction relative to the distal mounting block. The retraction system can be configured such that a third translation of the slider in the distal direction can cause the first contact member to move and disengage from the first clamp. The retraction system can be configured such that a third translation of the slider in the distal direction can cause both the first contact member and the second contact member to move and disengage from the first clamp and the second clamp.

[0010] The retraction system may include a first spring positioned to apply a first spring force to a first clamp, and the first spring force may be sufficient to move the first clamp from a closed position to an open position when the first contact engages and disengages from the first clamp. The first clamp may rotate about a first pivot joint. The first clamp may be attached to a shuttle at the first pivot joint. The first spring force may create a first rotation of the first clamp about the first pivot joint.

[0011] The second clamp may be fixed or it may be movable. If movable, the second clamp may move as a mirror image of the first clamp, and the pair of clamps may move from an open position to a closed position, and vice versa, by the movement of the two clamps. The retraction system may include a second contact positioned on a slider and configured to engage the second clamp. The first contact and the second contact may simultaneously engage and / or disengage the first clamp and the second clamp. The retraction system may include a second spring positioned to apply a second spring force to the second clamp, and the second spring force may be sufficient to move the second clamp from a closed position to an open position when the second contact engages and disengages from the second clamp. The second clamp may rotate about a second pivot joint. The second clamp may be attached to a shuttle at the second pivot joint. The second spring force may create a second rotation of the second clamp about the second pivot joint.

[0012] An exemplary system for deploying an implant may include an inlet, a pair of gripping arms, a shuttle, and a slider. The inlet may be sized to receive an elongate release member of an implant delivery system and to prevent proximal movement of a catheter of the implant delivery system. At least one of the pair of gripping arms is rotatable from an open position to a closed position. In the open position, the pair of gripping arms may be disengaged from the elongate release member, and in the closed position, the pair of gripping arms may be engaged with the elongate release member. The pair of gripping arms may be mounted to a shuttle, and the shuttle may be translatable in a proximal direction and a distal direction. The slider may be translatable in the proximal direction and the distal direction to engage or disengage one or both of the rotatable gripping arms such that when the slider initially moves proximally, the slider contacts the rotatable gripping arm and provides a force to rotate the rotatable gripping arm, thereby moving the gripping arm from the open position to the closed position. The slider may be further translated proximally to translate the shuttle and the pair of gripping arms proximally, and the proximal translation of the pair of gripping arms may retract the elongate release member proximally from the catheter.

[0013] The system may include a housing sized to be handheld, and the shuttle and the slider may be slidably mounted to the housing.

[0014] The exemplary system may include a distal mounting block, a proximal mounting block, and a guide rail extending between the distal mounting block and the proximal mounting block. A shuttle and a slider may each be slidably mounted on the guide rail. The system may include four guide rails.

[0015] The system may include an inlet, which is a tapered opening in the distal mounting block. The size of the tapered opening may be set to allow an elongate release member to pass through and engage the proximal end of the catheter.

[0016] The system may be configured such that translation of the slider distally may cause the slider to separate from the shuttle and disengage from a rotatable clamping arm.

[0017] The system may include at least one spring, and each spring may be positioned to apply a force to one or both of the rotatable clamping arms. The force from each spring may cause each spring-loaded clamping arm to move such that the pair of clamping arms move from a closed position to an open position or from an open position to a closed position.

[0018] An exemplary method may include steps for deploying an implant. The method may include providing an implant delivery system that includes a catheter and an internal elongate member positioned within the catheter and extending proximally from the catheter. The method may include providing a retraction system that includes an inlet, a slider, a shuttle, and a pair of clamping arms mounted to the shuttle.

[0019] The method may include positioning the pair of clamping arms in an open position. The method may include positioning the internal elongate member to pass through the inlet of the retraction system and between the pair of open clamping arms such that the clamping arms disengage from the internal elongate member. The method may include engaging the catheter of the implant delivery system to the inlet of the retraction system.

[0020] The method may include moving the slider proximally by a first distance to contact at least one of the clamping arms. The method may include moving the slider proximally by a second distance to move the clamping arm in contact with the slider, thereby causing the pair of clamping arms to move from the open position to the closed position, whereby in the closed position, the clamping arms engage the internal elongate member. The clamping arms in contact with the slider may each be rotatable about a respective rotary joint, and the step of moving the slider proximally by a second distance may further include rotating the clamping arms in contact with the slider about their respective rotary joints.

[0021] The method may include moving the slider proximally by a third distance to move the shuttle and the clamping arms proximally, thereby retracting the internal elongate member proximally from the catheter while maintaining the position of the catheter.

[0022] The method may include moving the slider distally a fourth distance to disengage the slider from the clamping arm. When the slider is moved distally, the position of the inner elongate member may be maintained. The step may also include maintaining the position of the shuttling member as the slider is moved distally through the fourth distance.

[0023] The retraction system may include one or more springs, and the method may include, when the slider is not engaged with the clamping arm, providing the force from each of the springs to each of the movable clamping arms to move the clamping arms from the closed position to the open position.

[0024] The provided retraction system may further include a distal mounting block, a proximal mounting block, and a guide rail. The method may further include: extending the guide rail between the distal mounting block and the proximal mounting block; slidably mounting the slider to the guide rail; and slidably mounting the shuttling member to the guide rail proximal to the slider. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above and other aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numerals indicate the same structural elements and features in the various figures.

[0026] The drawings are not necessarily to scale, and instead will focus on showing the principles of the present invention. The drawings depict one or more specific embodiments of the device of the present invention by way of example and not limitation.

[0027] Figure 1A and Figure 1B is a diagrammatic illustration of an exemplary retraction system in accordance with aspects of the present invention, Figure 1B is Figure 1A a cross-sectional view;

[0028] Figure 2 is a diagrammatic illustration of an implant delivery system that can be used with the exemplary retraction system in accordance with aspects of the present invention;

[0029] Figure 3A and Figure 3B is a diagrammatic illustration of an exemplary retraction system in accordance with aspects of the present invention, where the proximal portion of the implant delivery system is positioned within the retraction system, the retraction system and the implant delivery system being positioned prior to retraction of the pull wire from the implant delivery system;

[0030] Figures 4A to 4D is a diagrammatic illustration of a cross-sectional view of an exemplary retraction system showing exemplary steps for performing deployment of an implant in accordance with aspects of the present invention;

[0031] Figure 4E is a diagrammatic illustration showing Figure 4D a top-down view of the retraction system positioned as such;

[0032] Figures 5A to 5D Diagrams showing a cross-sectional view and a top-down view of an exemplary retraction system that performs exemplary steps for releasing a pull wire and returning to a starting position in accordance with aspects of the present invention;

[0033] Figure 6 Diagram of an exemplary retraction system including a return spring in accordance with aspects of the present invention;

[0034] Figure 7A and Figure 7B Top and side perspective views ([ Figure 7A ) and side perspective view ([ Figure 7B ) of an exemplary retraction system in a starting position in accordance with aspects of the present invention;

[0035] Figure 8A and Figure 8B Side perspective view ([ Figure 8A ) and top perspective view ([ Figure 8B ) of an exemplary retraction system having a clamp in a closed position in accordance with aspects of the present invention;

[0036] Figure 9A and Figure 9B Side perspective view ([ Figure 9A ) and top perspective view ([ Figure 9B ) of an exemplary retraction system having a clamp in an open position in accordance with aspects of the present invention; and

[0037] Figure 10A and Figure 10B Diagrams of a pair of clamping arms including a rotatable clamping arm and a non-rotatable clamping arm in an open position ([ Figure 10A ) and a closed position ([ Figure 10B ) in accordance with aspects of the present invention. Detailed Description

[0038] Mechanical implant delivery systems, clot capture systems, and other systems actuated by an inner tube / outer tube assembly in which the inner tube translates relative to the outer tube may use one or more hypotubes or pull wires located within a guide catheter, and the hypotubes and / or pull wires may be used to manipulate the proximal end of the delivery system to deploy an implant, capture a clot, or perform other endovascular procedures at the distal end of the delivery system. Examples of mechanically deliverable implants include embolization elements, stents, grafts, drug delivery implants, flow diversion elements, filters, stimulation leads, sensing leads, or other implantable structures that can be delivered through a microcatheter. The exemplary retraction systems described herein may interface with the proximal end of a delivery system to assist a user in separating and / or deploying an implant or capturing a clot at the distal end.

[0039] An exemplary retraction system may generally include a system of components that can retract an internal hypotube and / or a pull line during and after the release of an implant without producing distal movement of the hypotube / pull line and its subcomponents. An exemplary retraction system may include a mechanical slider that a user can translate in a single linear motion. The slider can apply torque to one or both of a pair of clamping arms when being retracted. The torque can move the clamping arms to compress and grip onto the proximal inner tube or pull line. The grasped elongated member can be translated relative to the main delivery tube by sliding the slider toward the proximal side. The retraction system may include an indicator that indicates to the user when the slider has reached its end of travel, for example, the indicator may be a tactile indicator and / or an audible indicator. The travel distance of the slider may be set so that the implant is released when the slider approaches or reaches its end of travel. The indicator can indicate to the user that the implant has been released.

[0040] The retraction system may include one or more springs positioned to cause the clamp to open and release the engaged elongated member when the user releases pressure on the slider. The retraction system may include a mechanism (such as a spring or known member) for returning the retraction system to a starting or initial position.

[0041] Possibly, the retraction system can provide a more reliable separation of an embolism or other implant over a mechanical separation system than a conventional retraction system. A more reliable separation can be achieved by retracting a puller wire, inner tube, puller wire / inner tube assembly, or other elongated member proximally during and after the release of the implant without causing advancement or distal movement of the implant delivery system components.

[0042] Figure 1A and Figure 1B is a diagram of an exemplary retraction system 100 . Figure 1B for Figure 1A sectional view of . Figure 1A and Figure 1B Components of an exemplary retraction system 100 are shown in a starting or initial position, wherein a proximal portion of an implant delivery system having a delivery catheter 410 and an inner tube, a pull wire, or an inner tube and pull wire assembly 310 ("pull wire") is positioned in the retraction system 100 and ready for deployment of the implant (or an intraluminal procedure).

[0043] The retraction system 100 may include a shuttle 130 having clamps 144, 146 for gripping a pull wire 310, a slider 120 that can be moved by a user, one or more sliding guides 116 on which the shuttle 130 and the slider 120 slide, a distal mounting block 114 for receiving an implant delivery system and providing an anchor for the sliding guides 116, and a proximal mounting block 112 for anchoring the sliding guides 116. The retraction system 100 may be configured to receive a delivery catheter 410 and a pull wire 310 of an implant delivery system, grip the pull wire 310, engage a proximal end of the delivery catheter 410, and pull the pull wire 310 to retract the pull wire 310 from the delivery catheter 410.

[0044] The system 100 may be mounted within a hand-held retractor, on a flat surface, or on a patient. When the system 100 is mounted within a hand-held retractor or handle, the distal mounting block 114 and the proximal mounting block 112 may be integral parts of the housing or casing of the hand-held retractor. The system 100 may include one or more guides 116 extending between the distal mounting block 114 and the proximal mounting block 112. When the system 100 is mounted within a hand-held retractor, the one or more guides 116 may extend between portions of the housing of the hand-held retractor and / or may be incorporated within the housing. The guides 116 may be grooves or tracks in the housing or handle casing. The retraction system 100 may include an opening 118 sized to permit the pull wire 310 to pass through but to prevent the delivery catheter 410 from passing through. The opening 118 may be tapered to facilitate alignment of the pull wire 310 and the delivery catheter 410 relative to the system 100, to facilitate insertion of the pull wire 310 into the system 100, and / or to securely engage a range of delivery catheters of various sizes. The opening 118 may be located in the distal mounting block 114.

[0045] The implant delivery system 300 may be inserted into the self-aligning tapered opening 118 at the entrance of the retraction system 100. The main delivery catheter 410 may have a hard stop at the entrance 118 of the device, and the internal elongate member 310 may freely enter the retraction system 100. The internal elongate member 310 may be inserted through the distal mounting block 114, the slider 120, and the shuttle 130.

[0046] The slider 120 may include an opening 128 sized to permit the drawstring 310 to pass therethrough. The slider 120 may include a handle 122 that can be grasped by a user or otherwise directly or indirectly manipulated by the user to move the slider 120. The slider 120 may include one or more contacts 124, 126 for engaging one or more of the clamping arms 144, 146 on the shuttling member 130 and providing a force thereagainst. The slider 120 may include a first contact 124 and a second contact 126 positioned to engage the first clamping arm 144 and the second clamping arm 146, respectively, and providing a first force and a second force thereagainst. The slider 120 may be mounted on the guide rail 116, and the slider 120 may move along the guide rail 116 in the distal direction 12 and the proximal direction 14.

[0047] The shuttling member 130 may include a pair of clamping arms 144, 146 that are capable of moving from an open position that permits the drawstring 310 to pass therethrough to a closed position that grasps the drawstring 310. The clamps 144, 146 may be mounted to the shuttling member 130, and one or both of the clamps 144, 146 may be movable. One or both of the clamps 144, 146 may be mounted to the shuttling member 130 at the rotary joints 154, 156. Each clamp 144, 146 may rotate about its respective rotary joint 154, 156, which rotation moves the clamp 144, 146 from the open position to the closed position and vice versa. Figure 1A and Figure 1B Shown are the clamps 144, 146 in the open position and the inner tube or drawstring 310 positioned between the clamps 144, 146 such that the drawstring 310 is not engaged by the clamps 144, 146. A first spring 134 may be mounted to the shuttling member 130, and the first spring 134 may apply a first spring force to the first clamping arm 144. The first force may be provided in a direction that moves and / or holds the first clamp 144 in the open position. A second spring 136 may be mounted to the shuttling member 130, and the second spring 136 may apply a second spring force to the second clamping arm 146. The second force may be provided in a direction that moves and / or holds the second clamp 146 in the open position. The shuttling member 130 may be mounted to the guide rail 116, and the shuttling member 130 may move along the guide rail in the proximal direction 12 and the distal direction 14. The shuttling member 130 may be positioned proximal to the slider 120. One or more spacer pins 138 may be slidably mounted through the shuttling member 130, and the spacer pins may be manipulated to maintain a set spacing between the slider 120 and the shuttling member 130, or the spacer pins 138 may be allowed to move such that the spacing between the slider 120 and the shuttling member 130 may collapse.

[0048] Figure 2Illustration of a proximal portion of a mechanical implant delivery system 300 (or other intraluminal treatment device) that can be used with exemplary retraction system 100. Delivery system 300 can include an inner tube, a pull wire, an inner tube and pull wire assembly, or some other elongate member 310 that is designed to retract from the proximal end 412 of delivery catheter 410 during intraluminal treatment. The elongate member 310 can be grasped by retraction system 100 near its proximal end 312 and pulled proximally from delivery catheter 410.

[0049] Figure 3A and Figure 3B Illustration of exemplary retraction system 100 with implant delivery system 300 positioned therein, where retraction system 100 and implant delivery system 300 are positioned prior to retraction of pull wire 310 from implant delivery system 300. Figure 3A Perspective view. Figure 3B Top-down view. Referring jointly to Figure 3A and Figure 3B , in an initial position, slider 120 can be positioned at the distal end of its stroke length, and shuttle 130 can be positioned near slider 120 and disengaged from slider 120 at the distal end of the shuttle's stroke length. The stroke lengths of slider 120 and shuttle 130 can depend at least in part on the positioning of distal mounting block 114, proximal mounting block 112, and one or more guide rails 116. Spacer pin 138 or spacer pins 138 are slidably mounted through shuttle 130 and extend to maintain the spacing between slider 120 and shuttle 130.

[0050] Figures 4A to 4D Illustration of a cross-sectional view of exemplary retraction system 100 showing exemplary steps for performing retraction of pull wire 310 from catheter 410. Figure 4A Exemplary retraction system 100 is shown in an initial position, such as as Figure 3A and Figure 3B shown. Delivery catheter 410 of implant delivery system 300 can be engaged at the inlet 118 of retraction system 100. Pull wire 310 can pass through inlet 118, through opening 128 in slider 120, and be inserted between clamping arms 144, 146.

[0051] Retraction system 100 can include a first clamping arm 144 having a first gripping region 145 and a second clamping arm 146 having a second gripping region 147. When retraction system 100 is in the initial position, pull wire 310 of implant delivery system 300 can be positioned between first gripping region 145 and second gripping region 147, but not gripped by first gripping region 145 or second gripping region 147.

[0052] The retraction system 100 may include a slider 120 that includes a first contact 124 and a second contact 126, each of the contacts 124, 126 being positionable to engage each of the clamping arms 144, 146 as the slider 120 moves toward the clamping arms 144, 146. When the retraction system 100 is in an initial position, the contacts 124, 126 may be disengaged from the clamping arms 144, 146. The retraction system 100 may include a first spring 134 and a second spring 136 for opening the clamping arms 144, 146. When the retraction system 100 is in the initial position, the first spring 134 may be positioned to hold the first clamping arm 144 in an open position, and the second spring 136 may be positioned to hold the second clamping arm 146 in an open position. The first clamping arm 144 may be mounted to the shuttle 130 at a first swivel joint 154, and the second clamping arm 146 may be mounted to the shuttle 130 at a second swivel joint 156. The first spring 134 and the second spring 136 may each be mounted to the shuttle 130, and when the retraction system 100 is in the initial position, the first spring 134 and the second spring 136 may prevent the first clamping arm 144 and the second clamping arm 146 from rotating about the respective swivel joints 154, 156.

[0053] The slider 120 and the shuttle 130 may each be slidably mounted to a guide rail 116 that permits the slider 120 and the shuttle 130 to move in a distal direction 12 and a proximal direction 14, the guide rail 116 preventing movement of the slider 120 and the shuttle 130 in a lateral direction orthogonal to the distal direction 12 and the proximal direction 14. The guide rail 116 may extend between a distal mounting block 114 and a proximal mounting block 112. When the retraction system 100 is in the initial position, the slider 120 and the shuttle 130 may be positioned near a distal end of the guide rail 116 proximate the distal mounting block 114.

[0054] The slider 120 may include a retraction handle 122 that may be manipulated by a user to move the slider 120 from Figure 4A the illustrated initial position to Figures 4B to 4D the illustrated subsequent position. The retraction system 100 may be designed such that a user may retract the handle 122 by grasping the handle 122 and pulling the handle toward the user's body. Alternatively, if the retraction system 100 includes a hand-held device, the retraction system 100 may be designed such that a user grasps the hand-held device with a hand while using a thumb or finger to move a slider or a trigger that is the handle 122 on the slider 120 or a mechanism connected to the handle 122 on the slider 120.

[0055] Figure 4B The retraction system 100 is shown, which is from Figure 4AThe initial position shown is moved such that the slider 120 is moved in the proximal direction 12 to engage the first contact 124 on the slider 120 with the first clamping arm 144 on the shuttle 130 and to engage the second contact 126 on the slider 120 with the second clamping arm 146 on the shuttle 130. In Figure 4B the situation shown, the pair of clamping arms 144, 146 can be held in the open position such that the inner tube 310 is not engaged by the first gripping area 145 of the first clamp 144 or the second gripping area 147 of the second clamp 146, and the shuttle 130 has not yet moved from its initial position.

[0056] Figure 4C The retraction system 100 is shown being moved such that the slider 120 is pulled proximally and a force is provided to the pair of clamps 144, 146 that causes the clamps 144, 146 to move from Figure 4A and Figure 4B the open position shown to Figure 4C the closed position shown. In the closed position, the first gripping area 145 and the second gripping area 147 are close to each other such that the pull wire 310 is engaged and gripped between the gripping areas 145, 147 of the pair of clamps 144, 146. The force provided by the slider 120 to the clamps 144, 146 can be sufficient to overcome the first spring force provided by the first spring 134 and the second spring force provided by the second spring 136, thereby causing the clamps 144, 146 to move to the closed position. When the clamps 144, 146 are open, the frictional force between the shuttle 130 and the guide rail 116 can prevent the shuttle from moving. Additionally or alternatively, the system 100 can include a flexure beam on which the shuttle 130 can slide, and the flexure beam provides a controlled resistance to the sliding of the shuttle 130. The user can translate the slider by pulling on the pull handle 122 of the slider 120, as Figure 4C shown. In Figure 4C the situation shown, the pull wire 310 is gripped by the pair of clamps 144, 146, but the pull wire 310 and the shuttle 130 have not yet moved from their initial positions.

[0057] The clamps 144, 146 can have an "L" shape. The "L"-shaped clamps 144, 146 can be positioned on the shuttle 130 such that the lower sides of the "L" shape are positioned opposite each other, and the upper side portions of the "L" shape are positioned to be contacted by the slider 120. The respective gripping areas 145, 147 of each clamp 144, 146 can be positioned on the lower side of each "L" shape. The force provided by the slider 120 to each respective clamp 144, 146 can be provided near the top of the "L" shape against the back side of the "L" shape, as Figure 4CAs shown. Each contact 124, 126 on the slider 120 can be positioned to provide a force from the slider near the top of each "L" - shaped fixture 144, 146 to the back side. Each "L" - shaped contact can rotate about a swivel joint 154, 156. Each swivel joint 154, 156 can be positioned at the corner of each "L" - shaped form. The first spring 134 and the second spring 136 can be connected near the top of the "L" - shaped form on the inside of the "L" - shaped form and are positioned opposite each corresponding contact 124, 126.

[0058] Figure 4D The retraction system 100 is shown, where the shuttle 130 and the pull - wire 310 are moved proximally. Once the clamping arms 144, 146 are rotated to grasp the pull - wire 310 as Figure 4C shown, the shuttle 130 can begin to translate as the slider 120 moves proximally, and the pull - wire 130 can begin to be withdrawn from the catheter 410. The user can continue to pull the slider 120 proximally, thereby pulling the pull - wire 310 out of the catheter 410 until the desired distance is reached. By pulling the pull - wire 310 backward while holding the catheter 410 fixed at the inlet 118 of the retractor system 100, the implant separation step (or other such endovascular procedure step) can be completed. When the slider 120 has reached the end of its travel, the slider 120 component of the retraction system 100 can prevent the slider 120 from moving further proximally, thereby providing an indication to the user that the handle or mechanism has completed its cycle, thus completing the procedure step. The implant (or other treatment device) can be observed under fluoroscopy to verify whether the separation (or other procedure step) has been correctly completed.

[0059] Figure 4E The retraction system 100 is shown in a top - down view in the Figure 4D position shown. Figure 4D is Figure 4E a cross - sectional view of the system 100 shown, as Figure 4E indicated.

[0060] Figures 5A to 5D is an illustration of an exemplary retraction system 100 showing exemplary steps for performing the release of the pull - wire 310 and returning to the initial position. After the separation of the implant is completed, the user can release the pressure on the slider 120, and the springs 134, 136 can automatically move the clamping arms 144, 146 to open, thereby releasing the fixtures 144, 146 from the proximal inner tube or the pull - wire 310. Once the pull - wire 310 is released, the shuttle 130 and the slider 120 can be moved proximally to return the system 100 to the starting position, but without translating the pull - wire 310 proximally. The system 100 can return to the starting position manually or automatically.

[0061] Figure 5A A cross-sectional view of an exemplary retraction system 100 for releasing the pull wire 310 immediately after completion of the implant separation step (or other such intraluminal treatment step). After completion of the treatment step, the user may allow the slider 120 to disengage from the engagement clamps 144, 146. The user may release the retraction handle 122, and the first spring force and the second spring force may be sufficient to move the first clamp 144 and the second clamp 146 to the open position. The pull wire 310 may be disengaged by moving the pair of clamps 144, 146 from the closed position to the open position. Once the pull wire 310 is disengaged from the clamps 144, 146, the shuttle 130 and the clamps 144, 146 may be moved, but the pull wire 310 may not be moved relative to the delivery catheter 410. Figure 5A The first gripping region 145 and the second gripping region 147 for separating to release the pull wire 310 are shown.

[0062] Figure 5B Shown in a top-down view as positioned as Figure 5A The retraction system 100 shown. The retraction system 100 may include spacer pins 138 slidably mounted in the shuttle 130. When the slider 120 moves to disengage the clamp 144, the slider may move away from the shuttle 130. Each spacer pin 138 may be attached to the slider 120 and slidably mounted through the shuttle 130 using a sliding fit such that the end of each spacer pin 138 is attached to the slider 120, and each pin 138 slides through the shuttle 130 as the slider 120 moves distally away from the shuttle 130 (the slider 120 moves from the Figure 4D and Figure 4E position shown to the Figure 5A and Figure 5B position shown). This configuration may be advantageous because when the slider 120 is pulled distally, both the shuttle 130 and the slider 120 may translate distally. The head of each spacer pin may engage the shuttle 130, and when the slider is pulled distally, the shuttle may be dragged distally by the pin 138.

[0063] Figure 5C Shown in a top-down view of the distal movement of the shuttle 130 and the slider 120 after releasing the pull wire 310 as shown in Figure 5A and Figure 5B . The distal movement may be achieved by applying a force to each spacer pin 138 (such as by Figure 5Cor by pushing the slider 120 distally via the pull handle 122 to move the shuttle 130 and the slider 120 distally. In either case, the spacer pins 138 can maintain the spacing between the shuttle 130 and the slider 120. Each spacer pin 138 can have a head that can engage the shuttle 130. The shuttle 130 can be moved distally by further applying a force against the spacer pins 138, and the spacer pins 138 can maintain the spacing between the contacts 124, 126 and the clamps 144, 146 such that the contacts 124, 126 do not engage the clamps 144, 146 when the shuttle 130 and the slider 120 are moved distally. The clamps 144, 146 can be held in the open position when the shuttle 130 and the slider 120 are moved distally, and the pull wire 310 and the delivery catheter 410 can maintain their extended positions when the shuttle 130 and the slider 120 are moved distally.

[0064] Figure 5D The retraction system 100 is shown returned to the initial position. The slider 120 can slide distally along the guide rail 116 until it is blocked by the distal mounting block 114. The shuttle 130 can be moved distally provided that the clamps 144, 146 are held in the open position. The shuttle 130 can be moved distally until the clamps 144, 146 encounter the contacts 124, 126 on the slider. The spacer pins 138 can be positioned to maintain the spacing between the shuttle 130 and the slider 120 such that the contacts 124, 126 do not contact the clamps 144, 146 when the shuttle 130 reaches the distal end of its travel.

[0065] Figure 6FIG. is an illustration of an exemplary retraction system 100 including a return spring 160. The return spring 160 may be mounted between the slider 120 and the distal mounting block 114 such that the return spring 160 provides a spring force that pulls the slider 120 distally to an initial position or holds the slider 120 in the initial position. The return spring 160 may be in a relaxed state when the slider 120 is in the initial position and in an extended state when the slider 120 moves proximally from the initial position. A user may provide a force to overcome the spring force and move the slider 120 proximally, and then release the slider 120 to allow the return spring 160 to return the slider 120 to the initial position. When the slider 120 first moves proximally, the slider 120 may engage the clamps 144, 146, causing the clamps 144, 146 to grip the pull wire 310 and move the shuttle 130 proximally. When the slider 120 is subsequently released, the slider 120 may disengage from the clamps 144, 146 and allow the shuttle 130 to remain in its current position as the slider 120 returns to the initial position. The retraction system 100 may be configured such that the slider 120 may move proximally again to engage the clamps 144, 146, grip the pull wire 310, and move the shuttle 130 through a second distance, causing the pull wire 310 to extend further from the catheter 410. Additionally or alternatively, the system 100 may include a tension spring for returning the slider 120 to and / or holding the slider 120 in the initial position, the tension spring being mounted to connect the slider 120 and the proximal mounting block 112.

[0066] Figure 7A and Figure 7B FIGS. are top and side perspective views Figure 7A () and side perspective views Figure 7B () of an exemplary retraction system 100 in an initial position, where the slider 120 and the shuttle 130 are positioned at the distal ends of their strokes and the clamping arms 144, 146 are open.

[0067] Figure 8A and Figure 8B FIGS. are side perspective views Figure 8A () and top perspective views Figure 8B () of an exemplary retraction system 100 having the clamps 144, 146 in a closed position. The system 100 may include a spacer pin 138 that may move from an extended position as shown in Figure 7A and Figure 7B to a retracted position as shown in Figure 8A and Figure 8B . In the extended position, the spacer pin 138 may define the spacing between the slider 120 and the shuttle 130 such that the contacts 124, 126 are separated from the clamping arms 144, 146. In the retracted position, the spacer pin may move to allow the contacts 124, 126 to engage the clamping arms 144, 146.

[0068] Figure 9A and Figure 9B A side perspective view ([[]] Figure 9B ) and a top perspective view ([[]] Figure 9A ) of an exemplary retraction system 100 having contact members 124, 126 that contact fixtures 144, 146 and the fixtures 144, 146 in an open position. The retraction system 100 can include spacer pins 138 that are attached to the slider 120 and slidably mounted through the shuttle 130. When the slider 120 moves from the positions shown in [[]] Figure 8A and [[]] Figure 8B to the positions shown in [[]] Figure 9A and [[]] Figure 9B , the pins 138 can slide through the shuttle 138. Figure 9A ) and a top perspective view ([[]] Figure 9B ) Figure 9B ) of the retraction system 100. The retraction system 100 can include spacer pins 138 that are attached to the slider 120 and slidably mounted through the shuttle 130. When the slider 120 moves from the positions shown in [[]] Figure 8A and [[]] Figure 8B to the positions shown in [[]] Figure 9A and [[]] Figure 9B , the pins 138 can slide through the shuttle 138. When the slider 120 moves from the positions shown in [[]] Figure 8A and [[]] Figure 8B to the positions shown in [[]] Figure 9A and [[]] Figure 9B , the pins 138 can slide through the shuttle 138. Figure 8A and Figure 8B shown to the positions shown in [[]] Figure 9A and [[]] Figure 9B , the pin 138 can slide through the shuttle 138. Figure 9A and Figure 9B shown, the pin 138 can slide through the shuttle 138.

[0069] Figure 10A and Figure 10B are illustrations of an alternative configuration of a pair of clamping arms 144, 146 for the retraction system 100. The pair of clamping arms 144, 146 can include a rotatable clamping arm 144 and a non-rotatable clamping arm 146. Figure 10A The clamping arms 144, 146 are shown in the open position. The rotatable clamping arm 144 can be mounted to the shuttle 130 at the joint 154 and can rotate about the joint 154. The non-rotatable fixture 146 can be attached to the shuttle such that it translates proximally and distally with the shuttle 130 and does not move relative to the shuttle 130.

[0070] Figure 10B The clamping arms 144, 146 are shown in the closed position. The slider 120 can contact the rotatable clamping arm 144, causing it to rotate and approach the non-rotatable clamping arm 146 such that the pair of clamping arms 144, 146 grip the pull wire 310. The non-rotatable clamping arm 146 can be non-coplanar with the pull wire 320 such that when the rotatable clamping arm 144 is rotated, the pull wire 310 is slightly bent. In some configurations, by so configuring, the pull wire 310 can engage a larger gripping area 147 on the non-rotatable clamping arm 146 and thus can have a relatively increased gripping strength compared to an example using two rotatable clamping arms.

[0071] The description contained herein is an example of an embodiment of the present invention and is not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of the retraction system, including alternative geometries for the component parts, alternative materials for construction, alternative mechanisms for mounting the movable components, alternative mechanisms for incorporating the retraction system into a retractor or larger device, etc. These modifications will be apparent to those of ordinary skill in the art to which the present invention pertains and are intended to be within the scope of the following claims.

Claims

1. A retraction system for retracting an inner elongate member of an implant delivery system from a catheter, the retraction system comprising: A first clamp, the first clamp including a first gripping area; A second clamp, the second clamp including a second gripping area; A shuttle member that is translatable in a proximal direction and a distal direction, the first clamp and the second clamp being mounted on the shuttle member; and A slider that is translatable in the proximal direction and the distal direction, the slider including a first contact member and a second contact member, wherein a first translation of the slider in the proximal direction causes the first contact member to translate proximally to apply a first force from the first contact member to the first clamp, the first force causing the first clamp to move from an open position to a closed position, wherein, in the open position, the first gripping area and the second gripping area are positioned to allow the internal elongate member of the implant delivery system to pass therethrough, wherein, in the closed position, the first gripping area and the second gripping area are positioned to engage the internal elongate member, wherein a second translation of the slider in the proximal direction causes the first clamp and the second clamp to translate proximally to retract the internal elongate member proximally from the catheter of the implant delivery system while holding the catheter in place, wherein the first translation of the slider causes the second contact member to translate proximally to apply a second force from the second contact member to the second clamp, the second force causing the second clamp to move from the open position to the closed position, and wherein the first contact member and the second contact member simultaneously engage and / or disengage from the first clamp and the second clamp.

2. The retraction system according to claim 1, further comprising: A distal mounting block; A proximal mounting block; and A guide rail extending between the distal mounting block and the proximal mounting block, the shuttle member and the slider each being slidably mounted on the guide rail.

3. The retraction system according to claim 2, wherein the distal mounting block further comprises a first opening for receiving the implant delivery system, and wherein the size of the first opening is configured to prevent the catheter from moving proximally and to allow the inner elongate member to pass therethrough.

4. The retraction system according to claim 2, further comprising: A return spring connected to the slider and the distal mounting block for applying a sufficient return spring force to move the slider in the distal direction.

5. The retraction system according to claim 1, wherein a third translation of the slider in the distal direction moves the first contact member out of engagement with the first clamp.

6. The retraction system according to claim 5, further comprising: A first spring positioned to apply a first spring force to the first clamp, the first spring force being sufficient to move the first clamp from the closed position to the open position when the first contact member disengages from the first clamp.

7. The retraction system according to claim 1, wherein the first clamp is rotatable about a first swivel joint and is attached to the shuttle at the first swivel joint.

8. The retraction system according to claim 7, wherein the first force from the first contact member produces a first rotation of the first clamp about the first swivel joint.

9. A system for deploying an implant, the system comprising: An inlet sized to receive an elongate release member of an implant delivery system and to prevent proximal movement of the catheter of the implant delivery system; A pair of clamping arms rotatable from an open position, in which they are disengaged from the elongate release member, to a closed position, in which they are engaged with the elongate release member; A shuttle member that is translatable in a proximal direction and a distal direction, the pair of clamping arms being mounted on the shuttle member; and A slider that is translatable in the proximal direction and the distal direction, When the slider translates proximally, the slider contacts the pair of clamping arms, the slider applies a force to rotate the pair of clamping arms from the open position to the closed position, the slider applies a force to translate the shuttle and the pair of clamping arms proximally, and the pair of clamping arms translates proximally to retract the elongate release member proximally from the conduit. The slider includes a first contact and a second contact. A first translation of the slider in the proximal direction translates the first contact proximally to apply a first force from the first contact to a first clamping arm of the pair of clamping arms, the first force moving the first clamping arm from the open position to the closed position. The first translation of the slider translates the second contact proximally to apply a second force from the second contact to a second clamping arm of the pair of clamping arms, the second force moving the second clamping arm from the open position to the closed position. The first contact and the second contact simultaneously engage and / or disengage from the first clamping arm and the second clamping arm.

10. The system according to claim 9, further comprising: A housing sized to be handheld, with the shuttle and the slider slidably mounted to the housing.

11. The system according to claim 9, wherein the inlet is a tapered opening in a distal mounting block of the system.

12. The system according to claim 9, wherein when the slider translates distally, the slider separates from the shuttling member and disengages from the pair of clamping arms.

13. The system according to claim 12, wherein the shuttling member further comprises a pair of springs positioned to apply a force to the pair of clamping arms to move the pair of clamping arms from the closed position to the open position.

Citation Information

Patent Citations

  • Manual actuation system for deployment of implant

    US20110238147A1