Patent Description:
Medical devices, such as implants or other interventional, endosurgical, or urological devices, may be deployable in a patient or otherwise controllable by cables mechanically actuated at a proximal end of the deployment system, e.g., external to a patient. To accommodate several cables for actuation of the medical device, the catheter may have a larger diameter along its entire length, which may result in several challenges for a medical professional. For example, a mechanical deployment system may be difficult to navigate complicated or narrow body lumens, e.g., vessels, arteries, and the like, to accurately manipulate a plurality of cables extending along an entire length of a catheter to control the medical device. A medical professional may be limited in actuation control at the proximal end of the deployment system which may result in undesirable and/or limited repeatable positioning and deployment of the medical device.

Document <CIT> describes a heart valve annulus repair device having a tissue engaging member and a plurality of anchors. The tissue engaging member includes a loop of wire. Each of the anchors has a pointy front end and a back end and a slot that runs in a front-to-back direction. The anchors are distributed about the loop of wire with the front ends of the plurality of anchors facing the heart valve annulus and with the loop of wire passing through the slots. The device further includes means for implanting the anchors into the heart valve annulus tissue so that the tissue engaging member becomes affixed to the heart valve annulus.

This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. The invention relates to a deployment system as defined by claim <NUM>.

According to an embodiment of the present disclosure, a deployment system may include a catheter having a distal end and a proximal end. An actuator may be disposed at the distal end of the catheter and operatively connected to electrical connectors extending longitudinally along the catheter from the proximal end to the actuator. The electrical connectors may be configured for transmission of signals to the actuator. One or more connections may be coupled to the actuator and to a deployable medical device disposed at the distal end of the catheter.

In various of the foregoing and other embodiments of the present disclosure, a diameter of the proximal end of the catheter may be smaller than a diameter of the distal end of the catheter. A control box may be operatively connected to the electrical connectors at the proximal end of the catheter for sending the signals to the actuator. The deployable medical device may be positionable by the actuator in response to receiving the signals from the control box. The deployable medical device may be detachable from the one or more connections subsequent to the positioning. A support component may be extendable longitudinally along the catheter for support of the catheter. The electrical connectors may include electric wires, electronic wires, printed cables, or thermal wires, or combinations thereof. A connection to the actuators and/or the implant may be wireless. A control box may be wirelessly communicative with the actuator. A sensor may be included for detecting actuation of the one or more connections from the actuator. The control box may receive feedback to coordinate deployment of the medical device. The deployable medical device may be positionable by the actuator by linear movement, rotational movement, inch-worm actuation, rack-and-pinion actuation, a clutch mechanism, or complex displacements, or combinations thereof. The actuator may include an electric actuator, electrostatic piezoelectric actuator, thermal actuator, magnetic actuator, shape-memory material actuator, microactuator, or electroactive polymers, or combinations thereof.

According to an embodiment of the present disclosure, a method for deploying a medical device may include locating a distal end of a catheter at a desired location. The medical device may be positioned at the desired location by an actuator disposed at the distal end of the catheter. The actuator may be operatively connected to electrical connectors extending longitudinally from a proximal end of the catheter to the actuator. Signals may be transmitted by the electrical connectors to the actuator for the positioning of the medical device. One or more connections may be detached to separate the actuator and the medical device.

In various of the foregoing and other embodiments of the present disclosure, a diameter of the proximal end of the catheter may be smaller than a diameter of the distal end of the catheter. Signals may be sent to the actuator by a control box operatively connected to the electrical connectors at the proximal end of the catheter. The medical device may be positioned by the actuator in response to receiving the signals from the control box. The medical device may be detached from the one or more connections subsequent to the positioning of the medical device. The catheter may be supported by a support component extendable longitudinally along the catheter. The electrical connectors may include electric wires, electronic wires, printed cables, or thermal wires, or combinations thereof. The medical device may be positioned by the actuator by linear movement, rotational movement, inch-worm actuation, rack-and-pinion actuation, a clutch mechanism, or complex displacements, or combinations thereof. The actuator may include an electric actuator, electrostatic piezoelectric actuator, thermal actuator, magnetic actuator, or shape-memory material actuator, microactuator, or electroactive polymers, or combinations thereof. Actuation of the one or more connections from the actuator may be detected by a sensor, such that the control box receives feedback to coordinate deployment of the medical device.

The present disclosure is not limited to the particular embodiments described herein. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

It will be further understood that the terms "comprises" and/or "comprising," or "includes" and/or "including" when used herein, specify the presence of stated features, regions, steps elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof.

As used herein, the term "distal" refers to the end farthest away from the medical professional when introducing a medical device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing a medical device into a patient. A central axis means, with respect to an opening, a line that bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular frame, a strut, or a bore.

Embodiments of deployment systems and methods according to the present disclosure may be configured for electronic control to improve deployment of a medical device. Electric wires and/or printed wires or cables may control high force and/or high displacement actuator(s) placed just proximal, or just distal, to the medical device for manipulation, e.g., near the intended location of the medical procedure and site for deployment in the patient. The actuator may be coupled to one or more connections for positioning the medical device in the intended location during the medical procedure, including but not limited to pushing, pulling, deploying, repositioning, and/or otherwise controlling the medical device. By reducing and/or eliminating a plurality of mechanical wires or cables necessarily extending all the way out of the patient in order for manipulation of individual elements of the medical device having multiple degrees of freedom, smaller profile catheters in accordance with the present disclosure may be included in the deployment system, which may be more flexible for medical procedures and may provide for improved overall control of the medical device. A smaller system may reduce inadvertent and/or accidental contact with tissue. Existing systems may be larger and less flexible for extending through a tortuous anatomy, e.g., aortic arch, heart chambers, at the ostia of vessels and branches, the femoral artery, and/or across the caval arch. In some patients, systems extend through organs and/or tissue anatomy that may be diseased or otherwise sensitive or damaged, such as calcified vessels, aneurysms, and/or dissections. Systems and methods of the present disclosure may reduce, minimize, and/or eliminate adverse events such as inadvertently contacting sensitive or diseased tissue which may damage tissue resulting in spasms, hemorrhage, hematomas, infections, pseudoaneurysms, cardiac tamponade, nerve injury, dissections, puncture wounds, or other types of damage.

Embodiments of the deployment systems and methods may be configured for any number of medical devices for implantation in a patient, including but not limited to cardiovascular, gastrointestinal, pulmonary, urological, and/or vascular devices, in which an electric wire or other electric connector may instead provide signals for manipulation of individual elements in multiple degrees of freedom of the medical device for deployment and positioning as desired at the intended location in the patient.

Referring now to <FIG>, embodiments of deployment systems <NUM>, <NUM>', in accordance with the present disclosure are shown. As shown in <FIG>, the system <NUM> may include a catheter <NUM> having a proximal end <NUM> and a distal end <NUM>. The catheter <NUM> may be a hollow tube <NUM> having an outer surface 107a and an inner surface 107b, and extending along a longitudinal axis <NUM> a length "Lc". The catheter <NUM> may be formed of a flexible material, so that at least a portion of the length LC and the distal end <NUM> may navigate body lumens (which may have changing curvatures) to arrive at an intended deployment position in the patient.

In embodiments, a diameter "DA" of the proximal end <NUM> may be smaller than a diameter "DB" of the distal end <NUM>. For example, the proximal end <NUM> may be sized as approximately between <NUM>-<NUM> Fr. , and the distal end <NUM> may be approximately up to <NUM> Fr. In other embodiments, the proximal end <NUM> and the distal end <NUM> of the catheter <NUM> may be substantially the same, e.g., DA may be approximately equal to DB. As shown in <FIG>, for example, another embodiment of a deployment system <NUM>' may include a catheter <NUM>' having a proximal end <NUM>' and a distal end <NUM>', in which a diameter "D' A" of the proximal end <NUM>' may be equal to a diameter "D'B" of the distal end <NUM>'. Additional components described herein may be included in deployment systems <NUM>, <NUM>'.

The distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' may have a proximal portion <NUM> and a distal portion <NUM>. As shown in <FIG>, the distal end <NUM> may gradually transition from the diameter DA at the proximal portion <NUM> to the diameter DB at the distal portion <NUM> and/or may extend in stepped portions, such that the distal end <NUM> may form a frustoconical shape. In other embodiments, the proximal portion <NUM> and the distal portion <NUM> may have substantially the same diameter, e.g., as shown in <FIG>.

The proximal portion <NUM> of distal end of the catheter may include a reinforced area <NUM> for supporting an actuator <NUM>. The reinforced area <NUM> may be a substantially inflexible portion of the catheter <NUM>, <NUM>' to minimize collapse, kinking, and/or constriction at the reinforced area <NUM> as the catheter <NUM>, <NUM>' is navigated in the patient. In some embodiments, the reinforced area <NUM> may be a strengthened portion of the hollow tube <NUM>. The reinforced area <NUM> may be formed of a different material and/or include additional elements as compared to other portions of the catheter <NUM>, <NUM>' to have a higher strength at the reinforced area <NUM>. In some embodiments, the reinforced area <NUM> may include additional attachments of the actuator <NUM> to the hollow tube <NUM>. The reinforced area <NUM> may be included so that the catheter may withstand 'reaction' forces and/or torques applied during deployment of a selected medical device. In some embodiments, a reinforced area <NUM> may align with the diameter transition from the diameter DA of the proximal end <NUM> to the diameter DB of the distal end <NUM>, as shown in <FIG>.

The catheter <NUM>, <NUM>' may have a uniform wall thickness of the hollow tube <NUM> throughout the length LC of the catheter <NUM>, <NUM>' although in some embodiments, a wall thickness may taper from a thicker wall thickness at the proximal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' to a thinner wall thickness at the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'. A wall thickness of the catheter <NUM>, <NUM>' may be uniformly thinner along the length Lc of the catheter <NUM>, <NUM>' as compared to existing delivery systems by removal of bulkier mechanical cables.

The proximal end <NUM>, <NUM>' may remain external to a patient during a medical procedure, to allow a medical professional to control the distal end <NUM>, <NUM>' at the intended internal position for the procedure. The catheter <NUM>, <NUM>' may be insertable in a patient, with the distal end <NUM>, <NUM>' being positionable at a desired location for deploying a medical device. For example, an implant may be deployed for repairing a heart valve, an occlusion device may be positioned for redirecting and/preventing fluid flow in a body lumen, or any other number of grafts, stents, or other medical devices may be temporarily or permanently inserted in a patient by the system <NUM>, <NUM>' to improve patient health. In some embodiments, the systems <NUM>, <NUM>' may be used for actuating an accessory, such as biopsy forceps, graspers, snares, needles, or other instruments used in various applications such as endoscopic and/or pulmonary applications.

The system <NUM>, <NUM>' may include electrical connectors <NUM>, extending the length of the catheter <NUM>, <NUM>', e.g., from the proximal end <NUM>, <NUM>', to the distal end <NUM>, <NUM>'. The electrical connectors <NUM> may be operatively connected to a control box <NUM> disposed at the proximal end <NUM>, <NUM>'. The control box <NUM> may be configured to provide signals to an actuator <NUM> at the distal end <NUM>, <NUM>' of the system <NUM>, <NUM>' by the electrical connectors <NUM>.

Electrical signals controlling the deployment of the medical device <NUM> may allow for improved repeatability and precision for placement at the intended location in the patient by providing a more controlled positioning and deployment of the medical device through the actuator <NUM> at the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'. This control of a procedure may in some embodiments reduce procedure times and/or may allow for better and/or safer tracking of the system <NUM>, <NUM>' to the intended delivery location of the patient.

The electrical connectors <NUM> may be operatively connected to the actuator <NUM> for receiving electrical signals to actuate and deploy a medical device <NUM> to a desired position in the patient. In some embodiments, the control box <NUM> may be connected to the electrical connectors <NUM> via a cable <NUM> and may be connectable by connectivity components 125b and 175b as plug-in snap connections to respective connectivity component 125a at the proximal end <NUM>, <NUM>' of the catheter and 175a at the control box <NUM>. In some embodiments, the control box <NUM> may be wirelessly connected to the electrical connectors <NUM>. In some embodiments, the control box <NUM> may be wirelessly connected to the actuators <NUM> for communicating operation, release, or otherwise manipulation of the device <NUM>, e.g., Bluetooth, radio-frequency identification, or the like). In some embodiments, the control box <NUM> may be individually designed to the medical device for deployment, and in other embodiments the control box <NUM> may be an off-the-shelf design configured to deploy a plurality of different medical devices.

The electrical connectors <NUM> may extend longitudinally along the length LC and substantially parallel to the longitudinal axis <NUM> of the catheter <NUM>, <NUM>', from the connectivity component 125a for connection with the control box <NUM> at the proximal end <NUM>, <NUM>' to the actuator <NUM> at the distal end <NUM>, <NUM>'. The electrical connectors <NUM> may be disposed along the outer surface 107a of the catheter <NUM>, <NUM>', along the inner surface 107b of the catheter <NUM>, <NUM>', in the hollow tube <NUM> of the catheter <NUM>, <NUM>', and/or embedded in the hollow tube <NUM> of the catheter <NUM>, <NUM>'. In some embodiments, the electrical connectors <NUM> may be within the wall of the hollow tube <NUM>. The electrical connectors may be one or more wires, including but not limited to electric wires, electronic wires, printed cables, or thermal wires, or combinations thereof. The electrical connectors <NUM> may include insulated wires, fine gage wires, and/or printed electronics for transmitting voltages and currents to the actuator <NUM>. To account for potential tortuous anatomies as the system <NUM>, <NUM>' is delivered to the intended location of the medical procedure, the electrical connectors <NUM> may be formed straight and/or serpentine to build in slack in the connector to allow for bending of the catheter <NUM>, <NUM>' to minimize a risk of damaging and/or breaking the electrical connectors <NUM> under larger displacements, strains, and/or stresses. In some embodiments, the electrical connectors may be attached to the catheter outer surface 107a and/or inner surface 107b by flexible glues and/or other adhesives that allow for a flexibility to accommodate changing curvatures of the catheter <NUM>, <NUM>' during delivery to the intended location of the medical procedure. The electrical connectors <NUM> may additionally and/or alternatively include an insulation and/or coating to protect the electrical integrity during normal use and/or sterilization of the system <NUM>, <NUM>', which may not alter the flexibility of the electrical connectors <NUM> and/or attachment to the catheter <NUM>, <NUM>'.

The electrical connectors <NUM> may replace larger mechanical cables for individual element manipulation in existing systems, so that the diameter DA of the proximal end <NUM> of the catheter <NUM> may be smaller in size, thereby improving access to and delivery through the patient, as shown in <FIG>. In some embodiments, the catheter <NUM>' may have a constant diameter thickness, so that the proximal end diameter D'A is approximately equal to the distal end diameter D'B, as shown in <FIG>.

The diameter DA of the proximal end <NUM> may extend substantially the length LC. When the catheter <NUM> has a variable diameter, this reduced proximal and mid-catheter diameter may limit a "pushability" of the catheter <NUM>, such that the catheter <NUM> may be subject to kinking, or collapse, or both. Kinking and/or collapse may be a function of the larger diameter DB of the distal end <NUM> to accommodate a larger medical device <NUM>. It is also understood that a catheter <NUM>' having a constant diameter at the proximal and distal ends <NUM>', <NUM>', may also be subject to kinking and/or collapse.

A support component <NUM> may be included in the systems <NUM>, <NUM>', and may be disposed in the catheter <NUM>, <NUM>' and extending along the catheter <NUM>, <NUM>' to the distal end <NUM>, <NUM>'. A support component <NUM> may be included to strengthen and/or support the catheter <NUM>, <NUM>' along its length Lc, and may be formed as a straight rod, and/or a spiral rod. The support component <NUM> may be formed as a wire and may be any material having sufficient strength for applying forces to the proximal portion <NUM> of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>', or to the reinforced area <NUM>, including but not limited to composites. In embodiments, the support component <NUM> may be formed having a uniform diameter, although in some embodiments, the support component <NUM> may be a variable diameter to enhance flexibility.

The support component <NUM> may extend substantially parallel along the longitudinal axis <NUM> of the length LC of the catheter <NUM>, <NUM>'. The support component <NUM> may be disposed substantially along a center of the hollow tube <NUM>, and/or extend along the inner surface 107b. In some embodiments, a support component <NUM> formed as a spiral may extend along the inner surface 107b of the catheter <NUM>, <NUM>', which may be advantageous to enhance flexibility and/or torque forces applied to the actuator <NUM>. In some embodiments, the support component <NUM> may be a single rod, and/or may include a plurality of support components.

The actuator <NUM> may be disposed in the proximal portion <NUM> of the distal end <NUM>, <NUM>' of the catheter and may include a single actuator, or any number "n" actuators 130a, 130b,. 130n, for deploying the medical device <NUM>. In some embodiments, the actuator <NUM> may be disposed in the distal portion <NUM> of the distal end <NUM>, <NUM>'. The actuator <NUM> may be configured to provide sufficient forces needed for deployment of the selected medical device <NUM>, and may be individualized depending on the selected medical device <NUM>. For example, different forces, e.g., linear, rotational, varying distances, etc., may be necessary for deploying the medical device depending on the anatomy of the intended location of the medical procedure. The actuator <NUM> may be an electric actuator, electrostatic piezoelectric actuator, thermal actuator, magnetic actuator, shape-memory material actuator, microactuator, or electroactive polymers, or combinations thereof, to deploy the medical device <NUM> at the intended location of the procedure. The actuator <NUM> may be configured for various movement to position the medical device <NUM>, including but not limited to linear movement, rotational movement, inch-worm actuation, rack-and-pinion actuation, a clutch mechanism, or complex displacements, or combinations thereof. The actuator <NUM> may be configured for supporting a wide range of operational parameters including but not limited to electrical currents, forces, torques, and/or dimensions, although in some embodiments an actuator <NUM> having a narrower range of operational parameters may be used depending on the selected medical device and intended location for the medical procedure.

In some embodiments, operational parameters of the actuator <NUM> may not be sufficient for deploying the selected medical device <NUM> at the intended location of the medical procedure. The actuator <NUM> may then utilize a lower energy and/or displacement force to release a latch or other element to release a mechanism such as a linear spring, rotational spring, chemical reaction, or other energy source, that may generate sufficient forces to deploy the selected medical device <NUM>. For example, a spring may be held in a compressed position having a stored energy. The actuator <NUM> may initiate movement to release the spring, allowing the spring to expand and thus apply forces to the selected medical device <NUM>. The applied forces may be sufficient to deploy the selected medical device <NUM> from the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' as desired by the medical professional. In some embodiments, the systems <NUM>, <NUM>' may include mechanical actuating cables or wires in addition to the electrical connectors <NUM> and actuators <NUM>. This may be advantageous to overcome potential limitations in the forces, torque, displacement, rotations, energy, and the like applicable by the actuators <NUM>.

The actuator <NUM> may be configured to deploy, e.g., push, at least a portion of the medical device <NUM> out of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'. In some embodiments where the medical device <NUM> is formed of a shape memory material such as nitinol, the actuator <NUM> may be configured to unsheath, unconstrain, or otherwise release, at least a portion of the medical device <NUM> for expansion in the intended location of the procedure. In some embodiments, the actuator <NUM> may be configured to move and/or rotate at least a portion of the medical device <NUM>. In some embodiments, the actuator <NUM> may be configured to reposition at least a portion of the medical device <NUM>. In some embodiments, the actuator <NUM> may be configured to release therapeutic drugs or other agents from a reservoir or other compartment of the medical device <NUM> and/or the catheter <NUM>, <NUM>' (not shown). In some embodiments, therapeutic drugs or other agents may be pre-loaded in the catheter <NUM>, <NUM>' and/or medical device <NUM>.

The actuator <NUM> may be configured to deploy the medical device <NUM> by connections <NUM>. The one or more connections <NUM> may be removably coupled to the actuator <NUM> and to the medical device <NUM>. The one or more connections <NUM> may be sutures, strings, cables, sheaths, shape-memory material, screws, or any other material or geometry to retain the medical device <NUM> in the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' until deployment at the intended location of the medical procedure. The one or more connections <NUM> may include a release element, such as hooks, knots, adhesives, electromechanical, electrochemical detachment mechanisms, or other joining mechanisms, so that a medical device may be detachable from the one or more connections subsequent to deployment and satisfactory positioning at the intended location of the medical procedure.

The one or more connections <NUM> may be coupled to the actuator <NUM> and/or medical device <NUM> using multiple configurations such as screws and bolts, pins, hooks, weld joints, adhesives, magnets, and/or interference fits (where force and/or an actuated shape memory expansion or contraction may initiate release), and the like, or various combinations thereof. These couplings may be designed for the individual actuator <NUM> and/or medical device <NUM>, and may be manufactured using microfabrication processing based on the size, force, torque, thermal, magnetic, and/or additional design requirements. In other embodiments, the couplings may be off-the-shelf designs configured for accommodating a variety of different medical devices.

In some embodiments, the connections <NUM> may be of a predetermined length, so that the medical device <NUM> is extendable out of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' via the actuator <NUM> to a predetermined distance (see e.g., <FIG>). In some embodiments, the connections <NUM> may be formed of a shape memory material, so that the connections <NUM> are in a compressed state while the medical device <NUM> is in the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'. Upon deployment of the medical device <NUM> by the actuator <NUM>, the connections <NUM> may be uncompressed to allow positioning of the medical device a distance out of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'.

In some embodiments, as shown in <FIG>, a connection mechanism between a medical device and a catheter may be included in a deployment system. A deployable medical device, or implant, <NUM>, <NUM>' may include a connection <NUM> between the medical device <NUM>, <NUM>' and the deployment system, e.g., an actuator and/or catheter. The connection <NUM> may include a first component such as a medical device connector 260a, and a second component such as a deployment system connector 260b. The first component 260a may be a tube, or cap, or any other shape configured to receive and/or mate with the second component 260b.

In some embodiments, the second component 260b may be coupled to an actuator, although in other embodiments, the second component 260b may be coupled to an inner portion of a catheter for deploying the medical device <NUM>, <NUM>'. The first and second components 260a, 260b may be initially coupled, as shown in <FIG>, so that the separation may occur only when the medical device <NUM>, <NUM>' is placed in position as desired.

In embodiments, the second component 260b may have an initial diameter "DI," which may be slightly larger than inner diameter "DC" of the first component 260a, so that the first and second components 260a, 260b are fixedly coupled by an interference fit. As shown in <FIG>, when the medical device <NUM>, <NUM>' is deployed to a desired location, the second component 260b diameter may be reduced to "DR," which may be less than the initial diameter DI, as well as the inner diameter Dc of the first component 260a. When the second component 260b is at the reduced diameter DR, the first and second components 260a, 260b may be separated from each other, e.g., by retracting in a proximal direction indicated by arrow <NUM>. This may separate, or decouple, the medical device <NUM>, <NUM>' from the catheter, as shown in <FIG>. Although the first and second components 260a, 260b of the connection <NUM> are shown in <FIG> as cylindrical components, it is understood that the connections may be any shape configured to be detachably connectable to each other.

The second component 260b may be configured, such that the diameter may be adjustable by known means. The second component 260b may be formed of a compliant material. In some embodiments, the diameter may be adjusted by a mechanism operable via an actuator. For example, the second component 260b may be wound, or twisted, e.g., by a motor, to reduce the diameter from the initial diameter D<NUM> to the reduced diameter DR. As the second component 260b is wound, the compliant material may compress, thereby reducing the diameter enough to decouple from the first component 260a. In some embodiments, the second component 260b may be deflatable, e.g., a fluid may be utilized to adjust the diameter between the initial diameter D<NUM> and the reduced diameter DR. For example, a fluid may be flowed in and/or out of the second component 260b for inflation and/or deflation, thereby adjusting the diameter as desired. In some embodiments, the second component 260b may include a mechanism for expanding and/or contracting the second component 260b. For example, a plurality of arms may be connected to an actuator which may be movable between an expanded, or coupled position, and a retracted, or decoupled, position.

Additionally and/or alternatively, as shown in <FIG>, a medical device <NUM>' may include one or more connections coupled between an actuator <NUM> and the medical device <NUM>'. In some embodiments, the medical device <NUM>' may be medical device <NUM>, <NUM>. A connection <NUM>' may be detachably coupled to the medical device <NUM>' by a screw <NUM>. The actuator <NUM> may include a micro-motor for rotation of the screw <NUM> and/or connection <NUM>'. The screw <NUM> may be connected to a portion of the medical device <NUM>', and in some embodiments may include a plurality of screws <NUM> coupled to a plurality of connections <NUM>'. In some embodiments, the screw <NUM> may be configured to attach to a patient, thereby securing the medical device <NUM>' in the patient. In some embodiments, the screw <NUM> may be any connection mechanism, including but not limited to a screw, clip, helical anchor, and/or hook. The screw <NUM> may be adjustable by the connection <NUM>' to push, pull, and/or rotate the medical device <NUM>' for positioning in the patient prior to decoupling.

Understanding the forces applied to the medical device <NUM>, <NUM>, <NUM>' may be difficult for a medical professional to determine by visualization only. Additionally, some procedures may be difficult to visualize, such that placement of the device may be compromised. Sensors or microsensors, e.g., force, torque, linear displacement, rotational displacement, temperature, PH, flow, accelerometers, pressure, <NUM>-D compasses, gyroscopes, and the like, may be included in the system <NUM>, <NUM>' to improve the deployment of the medical device <NUM>, <NUM>, <NUM>', by allowing the medical professional to receive feedback via the sensors, electrical connectors, and/or control box, and from the system <NUM>, <NUM>' and make adjustments accordingly. For example, sensor feedback may coordinate single or multiple actuations, e.g., for adjusting the medical device mid-deployment, and/or adjusting the application of force on the device. The system <NUM>, <NUM>' may receive sensor feedback allowing for the medical professional to manually adjust operational parameters, although the system <NUM>, <NUM>' may also be configured for the control box <NUM> to receive sensor feedback for verification of the deployment and allow the next signals to be sent. If the sensor feedback indicates that the medical device is incorrectly positioned, an alert may indicate to the medical professional that manual adjustment may be needed, and/or if the procedure may continue or be aborted.

Sensor feedback may be advantageous for a medical professional for procedures where visualization is difficult, e.g., procedures performed under fluoroscopy or other image guidance to the intended location of the procedure. As described below with respect to <FIG>, for example, sensors may detect a deployment distance and/or number of rotations of anchors to secure a medical device <NUM> to tissue.

Referring now to <FIG>, an embodiment of a medical device is illustrated, e.g., as medical device <NUM>. As described above, a medical device may be any number of medical devices for deployment in a patient, including but not limited to temporary and/or permanent implants, and may be deployable in various body lumens and/or organs of the patient including for example, cardiovascular, gastrointestinal, urological, and/or other vasculature.

Each connection <NUM> is removably attached to an element of the medical device <NUM> for manipulation. For example, in some embodiments, the medical device <NUM> may include a plurality of elements having multiple degrees of freedom. Each connection <NUM> may manipulate each element to move the medical device <NUM> as desired. The connections <NUM> are individually controllable and operable by the actuator or multiple actuators <NUM>, which receives signals for each connection, to manipulate each element in a selected order to deploy and position the medical device <NUM> as desired.

The medical device <NUM> illustrated may be deployable in a patient's heart valve, e.g., as a transcatheter annuloplasty ring <NUM>. The ring <NUM> may include a plurality of struts or arms <NUM> connected to form the ring <NUM>, and movably coupled (e.g., hingedly coupled) to each other such as by connector <NUM>. In some embodiments, the connector <NUM> may be an actuatable sliding coupler. Each arm <NUM> may be hingedly coupled to the adjacent arm <NUM> at the connector <NUM>, such that the ring <NUM> may be movable from a first, compressed position, to a second, expanded position, as shown in <FIG>. A connection <NUM> may be connected at each connector <NUM> and attached to the actuator <NUM> to move the ring <NUM> from the first compressed position to the second expanded position.

The ring <NUM> may be in the first compressed position at the distal end <NUM> of the catheter <NUM> before deployment. It is also understood that catheter <NUM>', in which a proximal end <NUM>' has a diameter substantially equal to the distal end <NUM>', may be used to deploy the ring <NUM>. The connections <NUM> may be compacted, or compressed, between the actuator <NUM> and the ring <NUM> prior to deployment. When the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' is positioned at the intended location for the procedure, one or more signals may be sent from the control box <NUM> to the actuator <NUM> via the electrical connectors <NUM>. When the actuator <NUM> receives the signals, the actuator may actuate each connection <NUM> as per the signal for deployment (e.g., as shown in <FIG>). In some embodiments, the connections <NUM> may be extended a predetermined linear distance, e.g., substantially parallel to the longitudinal axis <NUM>, without expanding the ring to the second expanded position, so the ring <NUM> is extended out of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' but still in a first, compressed position. For example, the arms <NUM> may be held in a substantially closed position by the connector <NUM>, and the actuator <NUM> may not actuate the connection <NUM> to manipulate the connector <NUM> to expand the arms <NUM>.

When the connections have been extended to the predetermined linear distance, the actuator <NUM> may receive additional and/or alternative signals from the control box <NUM> to actuate the ring <NUM> in a radial direction. For example, the ring <NUM> may be moved to the second expanded position by the actuator <NUM> actuating the connections <NUM> to manipulate the connector <NUM>, such that the adjacent arms <NUM> are pivoted or rotated outward to move the ring <NUM> to the second expanded position.

Signals may continue to be sent to the actuators in a desired order to expand and/or position the ring <NUM> at the right or left atrium for repair of the tricuspid or mitral valve. The signals may be pre-programmed for deploying the ring <NUM>, signals may be sent based on sensor feedback of the positioning of the ring, and/or a medical professional may manually input instructions for sending signals to position based on visualization and/or other feedback. The ring <NUM> may be positioned in proximity to the valve <NUM> for attachment, e.g., via helical anchors <NUM>, and signals may be sent to the actuator <NUM> to adjust the connections <NUM> individually and/or as a group to align with the valve <NUM>. Upon alignment, the anchors <NUM> may be attached to annulus tissue surrounding the valve <NUM>, while the connections <NUM> are still attached to the connectors <NUM>. When the ring <NUM> is attached to the annulus tissue, signals may be sent from the control box <NUM> to the actuator <NUM> to manipulate the connections <NUM> to move the ring <NUM> from the second expanded position, to a third, repaired position. For example, the mitral or tricuspid valve <NUM> may be wider due to disease such that the valve may not fully close during pulsation of the heart. The ring <NUM> may be contracted to draw in the surrounding annulus tissue to valve <NUM>, thereby providing full closure. The connections <NUM> may be actuated by signals from the control box to position the ring <NUM> as desired, e.g., by hingedly opening and/or closing the arms <NUM>, to close the valve <NUM>. When the ring <NUM> has been positioned as desired, the anchors <NUM> may be fully implanted to secure the annulus tissue. The connections <NUM> may be disconnected from the connectors <NUM> to separate the ring <NUM> from the catheter <NUM>, <NUM>' and the catheter may be retracted from the patient.

Referring now to <FIG>, an embodiment of a process of deploying a medical device from a catheter is illustrated. A medical device <NUM> may be retained in the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' by one or more connections <NUM>, and it is understood that the process described may be applied to any of the medical devices <NUM>, <NUM>, <NUM>', <NUM> described herein. To perform a medical procedure, the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' may be inserted into a patient at an access point, which may vary depending on the procedure and the device for deployment. The medical professional may continue extending the catheter <NUM>, <NUM>' into the patient until coming within proximity to the intended location of the procedure. The medical professional may adjust the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>' so that the distal portion <NUM> is facing the desired deployment position of the medical device. The proximal end <NUM>, <NUM>' of the catheter, and the control box <NUM> may remain external to the patient, e.g., outside of the access point.

When the distal portion <NUM> of the distal end <NUM>, <NUM>' is in position, signals may be sent from the control box <NUM> via the electrical connectors <NUM> to the actuator <NUM> at the proximal portion <NUM> of the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>'. The signals may initiate action by the actuators <NUM>, such that connections <NUM> coupled to the actuator <NUM> and the medical device <NUM> may extend the medical device <NUM> distally out of the distal end <NUM>, <NUM>' of the catheter, as shown in <FIG>. In some embodiments, a cable, or wire actuation system, may retract the distal end <NUM>, <NUM>' of the catheter <NUM>, <NUM>', thereby at least partially enabling deployment of the medical device <NUM>. Actuators <NUM> and/or the connections <NUM> may initiate the operation for completing deployment of the medical device <NUM>. The signals may control the actuator <NUM> such that the connections extend the medical device <NUM> linearly, radially, rotationally, or any other type of movement, or combinations thereof. In some embodiments, the actuator <NUM> may first extend the medical device <NUM> only in a linear direction to exit the catheter <NUM>, <NUM>', and then proceed to more complex movements by the connections <NUM> once the medical device is free of the catheter <NUM>, <NUM>'.

As shown in <FIG>, after the medical device <NUM> has been extended out of the catheter <NUM>, <NUM>'; the connections <NUM> may expand the medical device <NUM>, e.g., larger than the diameter DB of the distal end of the catheter. Medical devices may be in a compressed state to allow for travel through the patient to the intended location of the procedure, requiring subsequent expansion or allowing for self-expansion, prior to placement and/or attachment to surrounding tissue. The actuator may receive signals from the control box <NUM> to perform this expansion after extending the device <NUM> out of the catheter <NUM>, <NUM>' or the device <NUM> may be self-expanding.

The medical professional may verify placement of the device <NUM>, and additional signals may be sent to the actuator <NUM> for fine tune adjustment for final positioning in the patient. Depending on the type of medical device <NUM>, it may be attached to surrounding tissue prior to separation of the connections <NUM> by additional actuation, although in some embodiments, the medical device <NUM> may self-position and/or align, and/or not require attachment to tissue.

When the medical device <NUM> is in position, the connections <NUM> may be separated from the device <NUM>. The connections <NUM> may have mechanisms for separation, such as hooks, screws, adhesives, clips, or other attachments, including as described above. After separation, the catheter <NUM>, <NUM>' may be removed from the patient.

Claim 1:
A deployment system (<NUM>), comprising:
a catheter (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>);
one or more electrically controlled actuator(s) (<NUM>) disposed at the distal end (<NUM>) of the catheter (<NUM>); and
one or more connections (<NUM>) coupled to the actuator and to a deployable medical device (<NUM>, <NUM>) disposed at the distal end (<NUM>) of the catheter,
wherein each connection (<NUM>) is removably attached to an element of the medical device (<NUM>, <NUM>)
wherein the one or more connections (<NUM>) are individually controllable and operable by the one or more actuators (<NUM>), which is configured to receive signals for each connection, to manipulate each element in a selected order to deploy and position the medical device (<NUM>, <NUM>).