Patent Description:
This document relates generally to medical systems and more particularly to systems, devices, and methods for robotic manipulation of an implant to alter position of shape of soft tissue.

Millions of people in the United States and around the world suffer from chronic voice disorders. Many of the chronic voice disorders are associated with vocal cord dysfunction or diseases. Vocal cords are two flexible bands of soft tissue composed of muscle collagen, elastin and ground substance that sit at the entrance to trachea. The two bands are normally positioned apart to allow air to flow during breathing. During speaking, the bands come together to produce sound as the passage of air from the lungs causes them to vibrate to make sound. Appropriate closure of the vocal cords during swallowing and coughing also protects the airway, preventing food, drink, and saliva from entering the trachea.

Vocal cord paralysis (VCP) is a common chronic voice disorder. Vocal cord paralysis is caused by disruption of nerve impulses to the voice box (larynx), resulting in immobility of the vocal cord muscles. VCP can cause hoarseness (dysphonia) most commonly characterized by a breathy or weak voice with roughness. VCP may also cause swallowing problems, and result in chocking leading to death in some extreme cases. In most cases of VCP, only one vocal cord is paralyzed, a condition known as unilateral vocal cord paralysis (UVCP). Dysphonia in patients with UVCP is related to incomplete closure of the vocal cords, such as due to deficient tone and bulk to an improperly positioned paralyzed vocal cord.

Chronic voice disorder may also be age related. Presbylaryngis (aging larynx) generally refers to age-related vocal cord changes including loss of volume and bowing of the vocal cord inner edges. Common symptoms of presbylaryngis may include reduced volume, high pitch, breathy sound, increased speaking effort, vocal fatigue, and difficulty communicating with others. The conformation and volume change in vocal cord edges narrows the gap between the vocal cords during speaking; and other muscles may subsequently push more tightly to compensate for reduced vocal cord closure.

Thyroplasty has been used to treat or alleviate chronic voice disorders associated with conformational change in vocal cords. Thyroplasty is a phono-surgical technique designed to improve patient voice by repositioning an abnormal vocal cord through an opening created in the thyroid cartilage of the voice box. A thyroplasty implant may then be positioned at or near a vocal cord to adjust vocal cord position, bulk and shape. Type I thyroplasty, also known as medialization laryngoplasty, is a surgical procedure that pushes a vocal cord toward the middle of the voice box. It is used for voice disorders resulting from weak or incomplete vocal cord closure, including unilateral vocal cord paralysis, presylaryngis, Parkinson's disease, abductor spasmodic dysphonia, as well as vocal cord atrophy, scar, and paresis (partial paralysis). Type II thyroplasty is a surgical procedure that pulls a vocal cord in lateral direction to weaken vocal cord closure. It has been used to address conditions including adductor spasmodic dysphonia with anticipated application for vocal tremor, refractory muscle tension dysphonia, and bilateral vocal cord paralysis.

<CIT> describes an implantable device capable of controlling cochlear implant electrode insertion and positioning. The device uses an implanted mechanical positioning unit to advance position and monitor an electrode array. The device can be controlled via an external controller to reposition or advance an electrode array at any point after implantation with no surgical re-intervention.

<CIT> concerns an insertion device allowing a doctor to alone perform an operation to insert a medical linear body. The insertion device, operated to insert a delivery wire into a human body through a blood vessel, includes a foot switch generating and outputting a signal to control starting/stopping a drive device moving the delivery wire in its longitudinal direction.

<CIT> describes a robotic catheter system with a magnetic coupling. The catheter system includes a first drive mechanism comprising a drive which interacts with a catheter device to cause the catheter device to move along its axis. A first encoder assembly that detects the motion of the catheter device by a magnetic interaction with the catheter device.

The invention is a system as defined in the appended claims. Methods disclosed herein do not form part of the claimed invention.

Thyroplasty involves surgically implanting an implant at or near a vocal cord in the voice box, and maneuver the vocal cord via the implant to secure the vocal cord into a desired position or to maintain a desired shape. Stabilizing the vocal cord at the appropriate position is critical in managing glottic incompetence (weakened voice production from incomplete vocal cord closure). In a conventional thyroplasty surgery, a surgeon inserts the implant into a patient's voice box by hand. This manual maneuvering of the thyroplasty implant may lack precision in implant positioning and motion control, such as the control of insertion rate, distance, or forces applied to the implant to move the implant to the target site in the voice box. Complete manual maneuvering of the thyroplasty implant may also be subject to high variability among surgeons, which may result in inconsistency in implant positioning. One reason for the inter-operator variability may be related to tissue swelling induced by the implantation surgery. Because of the swelling, it can be difficult for a surgeon to estimate an appropriate amount of medial displacement (e.g., in Type I thyroplasty) or lateral displacement (e.g., in Type II thyroplasty) to be applied to the vocal cords during the surgery. As a result, speculation may be required to account for anticipated post-surgical changes in the position and shape of the vocal cords and surrounding tissue in the ensuing days and weeks as the swelling diminishes. As a result, there can be substantial differences in patient outcomes among institutions and surgeons of differing skill levels. Even experienced thyroplasty surgeons at high-volume institutions have inconsistent results. A recent report from such an institution identified sufficiently poor results at <NUM> weeks follow-up that <NUM>% of patients were offered revision surgery.

Conventional thyroplasty is subject to high revision rate following the initial surgery. Improvement in vocal quality at the time of surgery may often be followed by deterioration days to weeks later due to resolution of the swelling induced by the surgery, or even years later due to loss of bulk (atrophy) on both the paralyzed cord either due to pressure of the implant or the absence of nerve supply. For these patients, implant revision is often required to reposition the implant to optimize vocal cord position or shape. Because existing thyroplasty implants are static (i.e., lacking capability of flexibility of adjusting implant position or conformation after surgical site closure), a repeat surgery is usually required to modify an existing implant. Repeated surgery not only subjects the patient to additional risk of complication, but also increases complexity and cost for patient management. For these reasons, the conventional thyroplasty procedure is not an optimal long-term solution for many patients with chronic voice disorders.

Less-invasive techniques have been developed to address the repeated intervention associated with thyroplasty implant revision. Injection laryngoplasty is a procedure where a surgeon passes a needle connected to a syringe filled with augmentation material transcutaneously into the vocal cord. The augmentation material is then deposited into the vocal cord to add bulk to one or both of a patient's vocal cords to move its contact area toward the midline, thereby reducing the loss of air and improving the symptoms. Although this approach is less invasive than thyroplasty, gradual resorption of the implant material may occur following the injection, usually in an unpredictable manner. Some studies have shown that injectables made of longer-lasting calcium hydroxyapatite may remain up to <NUM> months after injection. The resorption may slowly decrease the bulk of the vocal cord, and deteriorates patient voice quality over time. When the resorption occurs, the patient may need repeat injection or alternative longer lasting thyroplasty procedure. For this reason, injection laryngoplasty is considered in many cases to be a temporary solution to correct chronic voice disorders.

For the foregoing reasons, the present inventors have recognized a significant need to improve the medical technology of thyroplasty, particularly to enhance surgical precision in implant delivery and positioning, and flexibility and accuracy in non-invasive revision of an existing thyroplasty implant. The present document discusses, among other things, systems, devices, and methods of robotically assisted positioning of an implant in a patient, and manipulation of the implant to alter position or shape of target soft tissue. The system may include a robotically controlled implantable positioning unit (IPU) that allows a surgeon to remotely and dynamically control the positioning and fine-tune the conformation of the implant. The systems and devices discussed herein may be used not only in an initial implantation surgery, but also in a revision procedure without disruption the skin or adjacent tissue. By way of non-limiting example, the system and devices discussed herein may be used to manipulate a thyroplasty implant, either during initial thyroplasty surgery or subsequent revision procedure, to alter the position, shape, and bulk of a vocal cord to treat various chronic voice disorders, such as medializing a vocal cord to reduce the gap between vocal cords, or lateralizing a vocal cord to weaken vocal cord closure or to enlarge glottis aperture to improve airway opening and ventilation.

The systems and devices discussed herein may improve treatment of many types of voice disorders by enabling non-invasive, transcutaneous control of implant position and conformation to optimize patient vocal quality as age and other factors cause the laryngeal anatomy to evolve over time. In an example, the present system and devices may be used to manage glottic incompetence (incomplete vocal cord closure), such as resulted from aging (presbylaryngis), vocal cord atrophy and scar, or resection of tumors of the vocal cords. In another example, the present system and devices may be used to improve weakened vocal cord closure associated with neurological disorders, such as Parkinsons, abductor spasmodic dysphonia, or vocal tremor. In some examples, the present system and devices may also be used to lateralize the vocal cord to induce or weaken glottic closure in patients with adductor spasmodic dysphonia, refractory muscle tension dysphonia, or vocal tremor.

This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense.

In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. References to "an", "one", or "various" embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description provides examples, and the scope of the present invention is defined by the appended claims.

Disclosed herein are systems, devices, and methods for robotically assisted implantation and manipulation of an implant in a patient to alter a position or a shape of target soft tissue. The present system may be implemented using a combination of hardware and software designed to provide precise control of implant movement, such as insertion of a thyroplasty implant and/or guide sheath during a thyroplasty surgery, or non-invasive revision of an existing thyroplasty implant. An embodiment of the system includes an implantable positioning unit (IPU) configured to engage the implant, deliver and position the implant to interface with the target soft tissue. A user may operate on an external control console to control the IPU to manipulate the implant, and to alter the position and shape of the target soft tissue. In an example, the system may be used in a thyroplasty surgery to position and manipulate a thyroplasty implant to modify a vocal cord, such as to medialize or lateralize the vocal cord to restore or improve voice quality.

Although the discussion in this document focuses on manipulating a thyroplasty implant to alter vocal cords to treat voice disorders, this presentation is meant only by way of example and not limitation. The systems, devices, and methods discussed herein may be used to manage glottic incompetence (incomplete vocal cord closure) resulting from aging (presbylaryngis), vocal cord atrophy and scar, or resection of tumors of the vocal cords; weakened vocal cord closure associated with neurological disorders, such as Parkinsons, adductor spasmodic dysphonia, or vocal tremor; or to induce or weaken vocal cord closure (enhance glottic incompetence) in patients with adductor spasmodic dysphonia, refractory muscle tension dysphonia, or vocal tremor. The systems, devices, and methods discussed herein may additionally be adapted to robotically deliver, steer, position, extract, reposition, or replace various types of implants or prosthesis as well as associated instruments. Examples of the implants may include leads, catheter, guidewire, guide sheath, or other mechanical or electrical devices. The implants may be designed for temporary or permanent implantation. The implants may additionally be used for medical diagnosis of a disease or other conditions such as diagnostic catheters, or for therapeutic purposes of cure, mitigation, treatment, or prevention of disease, such as implantable electrodes for stimulating cardiac, neural, muscular, or other tissues. Through the implant, the system or apparatus may interact with various soft tissue to alter its position, shape, conformation, or contour or topography of a portion thereof to achieve specific diagnostic or therapeutic effects (e.g. tissue expansion).

<FIG> is a diagram illustrating, by way of example and not limitation, a robotically assisted and dynamically controlled soft-tissue manipulator system <NUM> and portions of an environment in which the system <NUM> may operate. The soft-tissue manipulator system <NUM> may include an implantable positioning unit (IPU) <NUM> and an external control console <NUM>. The IPU <NUM> may be completely or partially implantable.

The IPU <NUM> may include one or more of a coupling unit <NUM>, a sensor circuit <NUM>, a power system <NUM>, a transponder <NUM>, and an implantable control circuit <NUM>. The coupling unit <NUM> may interface with an elongate member <NUM>. A soft-tissue implant <NUM> may be coupled to the elongate member <NUM> such as on a distal end thereof. The coupling unit <NUM> includes actuating members arranged to engage at least a portion of the elongate member <NUM>, and robotically propel the elongate member <NUM> to move soft-tissue implant <NUM> into a target site of a patient <NUM>. Examples of the actuating members may include motorized actuation via rollers, screws, gears, or rack-pinion, among others. In an example, the elongate member <NUM> may be an integral part of the soft-tissue implant <NUM>, such as a tubular implant body or an elongate or telescoping shaft. Examples of such an implant may include an implantable lead or catheter. Alternatively, the elongate member <NUM> may be a part of a delivery system detachably coupled to the soft-tissue implant <NUM>. Examples of such an implant may include a guidewire or an introducer that may snatch an implant at a particular location, such as at a distal portion of the elongate member <NUM>.

The coupling unit <NUM> may frictionally move the elongate member <NUM> to a specific direction (e.g., forward for implant insertion, or reverse for implant extraction), at a specific rate, or for a specific distance relative to a reference point such as the interface between the coupling unit <NUM> and the elongate member <NUM>. Examples of the coupling unit <NUM> may include a leadscrew, a clamp, a set of rotors, or a rack and pinion arrangement, among other coupling mechanisms. The coupling unit <NUM> may compress against at least a portion of the elongate member <NUM> to produce sufficient friction between the coupling unit <NUM> and the elongate member <NUM>. In some examples, the coupling unit <NUM> may include adjustable couplers for reversible or interchangeable connection between the IPU <NUM> and the elongate member <NUM>. In the event of implant exchange or replacement, the coupling unit <NUM> may operatively release the compression on the elongate member <NUM>, which may be then removed from the IPU <NUM>. A new implant with an elongate member may be reloaded and engaged into the IPU <NUM>. The IPU <NUM> need not be removed and may remain in place during implant replacement. Examples of the coupling unit <NUM> are discussed below, such as with references to <FIG>.

In some examples, the soft-tissue implant <NUM> may be delivered through a guide sheath. In some examples, the IPU <NUM> includes separate structures to control a guide sheath separately from the soft-tissue implant <NUM>. In other examples, the guide sheath may be positioned initially by the IPU <NUM>, and the soft-tissue implant <NUM> implanted through the previously positioned guide sheath. Examples including positioning of a guide sheath are further discussed with reference to <FIG>.

The soft-tissue implant <NUM> may be delivered and positioned at a target site such that the soft-tissue implant <NUM> interfaces with target soft tissue. The IPU <NUM> may manipulate the soft-tissue implant <NUM> to alter the position or the shape of at least a portion of the target soft tissue. In various examples, the soft-tissue implant <NUM> may include a soft-tissue prosthesis made of biocompatible material, such as Silastic, goretex, silicon, hydroxyapatite, titanium, or polymer, among other permanent or resorbable materials. In an example, the IPU <NUM> may be used in a phonosurgery (surgery on the voice box) to address various voice, swallowing, and breathing disorders. A surgeon may robotically control the IPU <NUM>, via the external control console <NUM> and wireless transponder, to position a thyroplasty implant inside patient voice box to interface with a vocal cord, and manipulating the thyroplasty implant to alter the position and shape of the vocal cord to restore or improve voice. Examples including the thyroplasty implant and adjustment of vocal cord position and shape are discussed below, such as with reference to <FIG>, <FIG>, and <FIG>.

Once the soft-tissue implant <NUM> has been positioned at the target site, the elongate member <NUM> may be disengaged from the soft-tissue implant <NUM>. Alternatively, the elongate member <NUM> may remain attached to the soft-tissue implant <NUM> following the implantation This allows a surgeon to re-optimize implant position in an implant revision procedure following the initial implantation without the need of a surgery to reattach the soft-tissue implant <NUM> to the elongate member <NUM>.

The power system <NUM> is configured to provide driving force to the coupling unit <NUM>. The power system <NUM> includes a motor that may generate driving force and motion, and a power transmission unit to transmit the driving force and motion to the coupling unit <NUM> to actuate the motion of the elongate member <NUM>. Examples of the motor may include stepper motors (e.g., micro- or nano-stepper motors), direct current (DC) motors, pneumatic or piezoelectric motors, ultrasonic motors, or linear motors, among others. The motor may be electrically coupled to a power source. In an example, the power source may include a rechargeable power source, such as a rechargeable battery or a supercapacitor. The rechargeable power source may be charged wirelessly by a portable device such as a handheld device with circuitry configured to transfer energy to the rechargeable power source through electromagnetic induction or other transcutaneous powering means.

In the example as illustrated in <FIG>, the power system <NUM> is at least partially included in or associated with the IPU <NUM>. Alternatively, the power system <NUM> may be at least partially included in or associated with the external control console <NUM>. In another example, the power system <NUM> may be separated from the IPU <NUM> and the external control console <NUM>, and coupled to the coupling unit <NUM> via a connection. The connection may be a part of the transmission unit.

The implantable control circuit <NUM> may be coupled to the transponder <NUM> to receive a motion control signal from the external control console <NUM>. In an example, the coupling between the implantable control circuit <NUM> and the transponder <NUM> is a wireless coupling. The motion control signal may specify values for various implant motion parameters, and can be generated according to user programming instructions such as provided via the user interface module <NUM>. The implantable control circuit <NUM> may control the motor to generate driving force and motion according to the received motion control signal, and drive motion of the elongate member <NUM> via the power transmission unit and the coupling unit <NUM>. Examples of the power transmission unit may include chains, spur gears, helical gears, planetary gears or gearhead, worm gears, miniature pulleys, shaft couplings, or timing belts, among others. The power transmission unit may adjust the speed or torque output from the motor, and to deliver specific output to the coupling unit <NUM>.

In various examples, the power system <NUM> may include two or more motors coupled to respective power transmission units, and the power transmission units are coupled to respective coupling units that engage the same elongate member <NUM> at different locations thereof. The two or more motors may be of the same or different types. The transponder <NUM> may receive from the external control console <NUM> a motion control signal for controlling each of the two or more motors. In an example, a user may program and control each of the motors independently, such as via the user interface module <NUM>. The motion control signal specifies the configuration of, and input voltage or current to, each of the motors. According to the motion control signal, the implantable control circuit <NUM> may control the two or more motors to generate respective torque, speed, or rotation direction Through the elongate member <NUM>, the IPU <NUM> may operatively move the soft-tissue implant <NUM>, and therefore adjusting the target soft tissue, in multiple axis and planes with up to six degrees of freedom (medial, lateral, superior, inferior, anterior, and posterior). In an example, a first motor produces a translational motion of the elongate member <NUM>, and second motor may produce a rotational motion of the elongate member <NUM>. The implantable control circuit <NUM> controls various translational motion parameters (e.g., translational rate, direction (advancement or withdrawal), distance relative to a reference point, a position of a distal end of the elongate member <NUM>, an amount of axial force applied to the elongate member <NUM>), and rotational motion parameters (e.g., angular position, angular displacement, angular velocity, or an amount of lateral or rotational force applied to the elongate member <NUM>).

In some examples, the soft-tissue implant <NUM> may be attached to two or more elongate members each representing an embodiment of the elongate member <NUM>. Each elongate member may be coupled to a respective coupling unit representing an embodiment of the coupling unit <NUM>. The transponder <NUM> may receive from the external control console <NUM> a motion control signal for controlling each of the two or more motors. According to the motion control signal, the implantable control circuit <NUM> may control the two or more motors to generate driving forces to independently move the respective elongate members in different direction (e.g., advancement or withdrawal) or at different rate. Through independent control of multiple elongate members, the IPU <NUM> may operatively move the soft-tissue implant <NUM>, and therefore adjusting the target soft tissue, in multiple axis and planes. For example, the soft-tissue implant <NUM> may not only be advanced or withdrawn translationally, but may slant or rotate at different angles, thereby manipulating the target soft tissue at a desired positon or with a desired shape. Examples of positioning and manipulating a soft-tissue implant coupled to multiple elongate members are discussed below, such as with reference to <FIG>.

In various examples, the implantable control circuit <NUM> may change the shape or physical dimension of at least a portion of the soft-tissue implant <NUM>, such as topography of an implant surface interfacing with the target soft-tissue. The soft-tissue implant <NUM> may include an array of micro-actuators on the tissue-interfacing surface of the implant. In response to an implant contour control signal from the external control console <NUM>, the implantable control circuit <NUM> may activate the micro-actuators to change tissue-contacting surface contour. The change in the implant shape may result in changes in position or shape of at least a portion of the soft tissue. Compared to the motion control of the soft-tissue implant <NUM> via the power system <NUM> and the elongate member <NUM> for "macro position adjustment" of the target soft tissue, the surface contour control of the soft-tissue implant <NUM> via the micro-actuators may be used for "micro position adjustment" of the target soft tissue. Examples of controlled change of implant surface contour and the associated micro adjustment of soft tissue position are discussed below, such as with reference to <FIG>.

The sensor circuit <NUM> may be configured to sense information about position or motion of the implant during implantation. The sensor circuit <NUM> may be attached to the motor or the power transmission unit within the power system <NUM>, or associated with the coupling unit <NUM>, to detection information about position of the implant. Examples of the sensor circuit <NUM> may include a Hall-effect sensor integrated in the motor, one or more optical sensors attached to the coupling unit, a capacitive sensor configured to detect implant motion. The sensor circuit <NUM> may include force sensors included in the power system <NUM> or the coupling unit <NUM>, or associated with the soft-tissue implant <NUM>, to sense a parameter indicative of force or friction imposed on the implant during the implant advancement such as axial, lateral, or radial forces when the soft-tissue implant <NUM> interacts with the target soft-tissue. Examples of the force sensors may include resistors, capacitive sensors, piezoelectric material, or a strain gauge, among others. In an example, the force may be indirectly sensed by measuring the current supplied to the motor. The current measurement may be transmitted to the external control console <NUM>, where it is converted to the force (or torque) using the torque-current curve predetermined and stored in the memory circuit <NUM>. In some examples, the sensor circuit <NUM> may include sensors on the soft-tissue implant <NUM> to provide information indicative of shape or contour of the tissue-contacting surface of the implant <NUM>, such as before and after applying voltage to the micro-actuators on the tissue-contacting surface of the implant.

The information acquired by the sensor circuit <NUM> may be forwarded to the external control console <NUM> via the communication link <NUM>, The sensor information may be displayed or otherwise presented in a specific media format in the output module <NUM>. In an example, the IPU <NUM> may include an indicator to produce a visual or audio notification in response to the sensed sensor signal satisfies a specific condition. The indicator <NUM> may include, for example, a light emitting diode (LED) that may be turned on when the sensed sensor signal indicates the implant reaches the target site. In some examples, the indicator may include a plurality of LEDs with different colors or different pre-determined blinking patterns. The LED colors or the blinking patterns may correspond to various events encountered during the implantation procedure.

The IPU <NUM> may be configured for subcutaneous implantation. An implantable position device such as the IPU <NUM> is advantageous in applications such as thyroplasty surgery, which may have a high revision rate following the initial implantation. The IPU <NUM> allows a surgeon to remotely and dynamically adjust the position of the pre-implanted thyroplasty implant, without the need of surgical intervention, to re-optimize patient vocal quality when the implant status or patient condition changes following the initial implantation. In an example, electrical and mechanical components of the IPU <NUM> may enclosed in a housing that may be anchored to an anatomical structure neighboring the target soft tissue. In another example, the components of the IPU <NUM> may be packaged into separate housings that may be implanted at different body locations. For example, the power system <NUM> and the coupling unit <NUM> may be enclosed in a first housing to be anchored to thyroid cartilage of the voice box neighboring the vocal cord, while the implantable control circuit <NUM>, the sensor circuit <NUM>, and the transponder <NUM> may be assembled on a circuit board enclosed in a second housing subcutaneously implanted at a body location away from the vocal box, such as under the skin on the neck or chest. Examples for anchoring the IPU to structures at various body locations are discussed below, such as to be discussed in detail with reference to <FIG> and <FIG>.

The IPU <NUM> may include a fixation member to allow for detachable affixation of the IPU <NUM> to the anchoring structure. The fixation may be invasive fixation that involves incision and/or penetration of the anchoring structure or the subcutaneous tissue. Examples of the fixation member may include one or more of a screw, a pin, a nail, a wire, a hook, a barb, a helix, a suture, a glue, or a magnet within the IPU <NUM> coupled to one or more magnetic screws or pins affixed to the body part of the patient <NUM>. In an example, the fixation member may include one or more of self-drilling screws, self-tapping screws, or self-piercing screws, such that no pilot hole needs to be drilled at the affixation site prior to screw installation.

In some examples, while some portion of the IPU <NUM> is implantable, at least a portion of the IPU <NUM> may be externally positioned, such as a portion of the power system <NUM> (e.g., power source, or motor), the sensor circuit <NUM>, or the transponder <NUM>, among others. The non-implantable components may be packaged and affixed to the skin of a body part using non-invasive fixation means, such as clamps, temporary glues, or other holding devices that prevent lateral motion relative to the patient <NUM>. The external package may be a compact and lightweight for direct attachment to the patient, such as on the patient neck or check during a thyroplasty implant surgery, while maintaining sufficient stability during the implantation. The external package may be sized and shaped to facilitate patient attachment, such as having a curved exterior surface that conforms to the contour of a body part of the patient <NUM>.

The contact surface of the IPU <NUM> may be processed to improve stability during the implant advancement procedure. In an example, the IPU <NUM> may have an exterior surface with a rough finish, such as ridges, corrugates, teeth, or other coarse surface textures. Additionally or alternatively, the IPU <NUM> may have one or more gripping elements configured to frictionally bond the IPU <NUM> to a body part of the patient <NUM>, such as the anchoring structure for subcutaneous implantation or epicutaneous placement. The gripping elements may be distributed on a portion of the exterior surface. Examples of the gripping elements may include penetrators such as spikes, pins, or barbs protruding from the exterior surface When the IPU <NUM> is pressed and held against the attachment region, the rough surface or the gripping elements may provide sufficient friction or gripping force to securely hold the IPU <NUM> in place relative to the patient <NUM> during the implantation advancement.

The external control console <NUM> may include a dedicated hardware/software system such as a programmer, a remote server-based patient management system, or alternatively a system defined predominantly by a controller software running on a standard personal computer. The external control console <NUM> may robotically control the coupling unit <NUM> to propel the elongate member <NUM> at specific rate, to a specific direction, for a specific distance, or at a specific maximum force, thereby positioning the soft-tissue implant <NUM> at the target site of the patient <NUM>. The external control console <NUM> may additionally receive information acquired by the sensor circuit <NUM>. The external control console <NUM> may also receive measurement data from external systems that can be directly related to implant position. The external control console <NUM> can utilize such measurement data (e.g., physiological measurements) for closed-loop control of implant positioning and manipulation. For example, the external control console <NUM> may receive patient voice input via the user interface module <NUM> as feedback to manipulate a thyroplasty implant, and thereby adjusting the vocal cord position and shape, as to be discussed in the following with reference to <FIG>. In various examples, the external control console <NUM> may include a physiologic sensor configured to sense a physiologic signal, such as respiration or muscular movement of the patient. The controller circuit <NUM> may determine dynamic motion control feedback, and control the positioning and manipulation of the implant further using the sensed physiologic signal.

The external control console <NUM> may include a user interface module <NUM> and a controller circuit <NUM>. The user interface module <NUM> may include a user input module and an output module. The user input module may be coupled to one or more input devices such as a keyboard, on-screen keyboard, mouse, trackball, touchpad, touch-screen, or other pointing or navigating devices. In some example, the user input module may be incorporated in a mobile device communicatively coupled to the external control console <NUM>, such as a handheld device. The user input module may be configured to receive motion control instructions from a user. The motion control instructions may include one or more target motion parameters characterizing desired movement of the elongate member <NUM> of the implant. For example, the target motion parameters may define maximum values or value ranges of the motion parameters. Examples of the target motion parameters may include a target movement rate, a target movement direction or orientation, a target movement distance, a target position of a distal end of the elongate member, or a target amount of force imposed on the elongate member <NUM>. The movement of the implant may be activated at intervals of a predetermined step size. In an example of implantation of a thyroplasty implant the target movement distance may range from <NUM> - <NUM> millimeter (mm). The target movement rate is approximately at <NUM>-micron intervals. The motion control instructions may include a pre-determined implant delivery protocol that defines target values of a plurality of motion parameters. The implant delivery protocols are designed to ease the programming of the motion control, and to minimize peri-surgical tissue trauma or damage to the surrounding tissue.

The user interface module <NUM> may allow a user to select from a menu of multiple implant delivery protocols, customize an existing implant delivery protocol, adjust one or more motion parameters, or switch to a different implant delivery protocol during the implant delivery procedure. The external control console <NUM> may include a memory circuit <NUM> for storing, among other things, motion control instructions. In an example, one of the delivery protocols may include use of intraoperative physiologic measures that can reflect immediate changes in soft-tissue mechanics and insertion trauma pre-, during-, and post-insertion of the soft-tissue implant <NUM>. In an example of implantation or revision of a thyroplasty implant, the delivery protocols may include use of intraoperative patient voice feedback.

The output module may generate a human-perceptible presentation of information about the implant delivery control, including the programmable motion control parameters, and the motion control instructions provided by the user. The presentation may include audio, visual, or other human-perceptible media formats, or a combination of different media formats. The output module <NUM> may include a display screen for displaying the information, or a printer for printing hard copies of the information. The information may be displayed in a table, a chart, a diagram, or any other types of textual, tabular, or graphical presentation formats. Additionally or alternatively, the output module <NUM> may include an audio indicator such as in a form of beeps, alarms, simulated voice, or other sounds indicator.

The output module <NUM> may also generate presentation of data sensed by the sensor circuit <NUM>, including data such as current position and movement rate of the implant, the force or friction applied to the implant motion. This allows a surgeon to monitor in real-time the progress of the implantation, and adjust the motion control as needed. The presentation may include real-time visual or audible notification with specified patterns corresponding to different types of events encountered during implantation. In an example, the output module <NUM> may include a visual indicator, such as a light emitting diode (LED) or an on-screen indicator on the display screen. A specific LED color or a specific blinking pattern may signal to the user a successful positioning of the implant at the target site. A different LED color or a different blinking pattern may alert an excessive force imposed on the implant due to unintended tissue resistance during the implant advancement. The output module <NUM> may additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern (e.g., continuous, intermittent, pulsed, sweep-up, or sweep-down sound). In an example, a beep or an alarm with a specific tone or pattern may signal to the user successful positioning of the implant at the target site. A beep or an alarm with a different tone or different pattern may alert an excessive force imposed on the implant. In an example, the beep or the alarm may go off continuously as the sensor senses the implant approaching the target site. The sound frequency or the pulse rate of the beep or the alarm may increase as the implant gets closer and finally reaches the target site. In an example, the frequency of the beep or the alarm may correspond to a rate of motion, such as sounding for every one millimeter of motion. Audible feedback on the motion parameters may be advantageous in that the surgeon may be notified in real time the implantation status or events encountered without the need to look away from surgical field. This may assist surgeon with enhanced surgical precision and patient safety. In some examples, the audible or visual sensor feedback may signal to the user that the sensed implant position, motion, or for has exceeded the programmed target or maximum parameter values.

The controller circuit <NUM> may be configured to generate an implant motion control signal and/or an implant contour control signal for controlling the IPU <NUM> to deliver, position, and manipulate the soft-tissue implant <NUM>. Such control signals may be generated according to the motion control instructions provided by the user via the user input module <NUM>. In accordance with the motion control signal, the implantable control circuit <NUM> may control the power system <NUM> to regulate one or more motion parameters of the elongate member <NUM>, such as a movement rate, a movement direction or orientation, a movement distance, a position of a distal end of the elongate member, or an amount of force imposed on the elongate member <NUM>, among others. In some examples, the controller circuit <NUM> may generate multiple motion control signals that may be used to respectively control multiple motors configured to drive different modes of motion (e.g., translational or rotational motions) on the same elongate member <NUM>, or to drive different elongate members, as discussed above. In some examples, the controller circuit <NUM> may control the motion of the elongate member <NUM> further according to information about patient medical history or disease state received via the user input module <NUM>, or stored in the memory circuit <NUM>. In accordance with the motion control signal, the implantable control circuit <NUM> may activate an array of micro-actuators such as by applying a voltage map to change tissue-contacting surface contour, thereby causing changes in shape or position of the target soft tissue.

The controller circuit <NUM> may remotely control the IPU <NUM> via a communication circuit <NUM>. The communication circuit <NUM> may transmit the motion control signal to the power system <NUM> via the communication link <NUM>. The communication link <NUM> may include a wired connection including universal serial bus (USB) connection, or otherwise cables connecting the communication interfaces on the external control console <NUM> and the power system <NUM>. The communication link <NUM> may alternatively include a wireless connection, such as a Bluetooth protocol, a Bluetooth low energy protocol, a near-field communication (NFC) protocol, Ethernet, IEEE <NUM> wireless, an inductive telemetry link, or a radio-frequency telemetry link, among others.

In various examples, the IPU <NUM> may include a manual control mechanism in addition to the robotic control of the coupling unit <NUM>. The manual control mechanism may bypass or override the robotic motion control of the soft-tissue implant <NUM>. Examples of the manual control mechanism may include a dial turn, a screw, or direct insertion technique. The output module <NUM> may enable a user to selectably enable a robotic mode for robotically assisted motion control via the power system <NUM>, or a manual override mode for manual motion control of the elongate member <NUM>. Alternatively, an operation on the manual control mechanism may automatically withhold or disable the robotic motion control of the elongate member <NUM>.

Portions of the external control console <NUM> may be implemented using hardware, software, firmware, or combinations thereof. Portions of the external control console <NUM> may be implemented using an application-specific circuit that may be constructed or configured to perform one or more particular functions, or may be implemented using a general-purpose circuit that may be programmed or otherwise configured to perform one or more particular functions. Such a general-purpose circuit may include a microprocessor or a portion thereof, a microcontroller or a portion thereof, or a programmable logic circuit, or a portion thereof. For example, a "comparator" may include, among other things, an electronic circuit comparator that may be constructed to perform the specific function of a comparison between two signals or the comparator may be implemented as a portion of a general-purpose circuit that may be driven by a code instructing a portion of the general-purpose circuit to perform a comparison between the two signals.

<FIG> illustrate normal vocal cords and those with vocal cord paralysis (VCP), a medical condition that may be treated or alleviated using the robotic soft-tissue manipulator system <NUM>. The vocal cords (also known as vocal folds) are located within the voice box (larynx) at the top of the trachea, consisting of two infoldings <NUM> and <NUM> of mucous membrane stretched horizontally, from back to front, across the larynx. The vocal cords <NUM> and <NUM> are attached posteriorly to the arytenoid cartilages, and anteriorly to the thyroid cartilage. Normally, as illustrated in <FIG>, the vocal cords <NUM> and <NUM> remain open when a subject is silent 210A, creating an airway through which one can breathe. When one speaks 210B, the vocal cords <NUM> and <NUM> each move towards the middle of larynx, and close the airway. The air from lungs is forced through the closed vocal cords <NUM> and <NUM> and cause them to vibrate, which generate sounds.

Opening and closing of the vocal cords are controlled by the vagus nerve. During VCP, nerve impulses to the small muscles controlling the voice box are disrupted, such that one or both of the vocal cords <NUM> and <NUM> are unable to move laterally during respiration, or to move medially during speech. <FIG> illustrates vocal cords in the case of unilateral VCP, which accounts for most cases of VCP. As an example, one cord <NUM> is paralyzed but the other cord <NUM> is normal. The paralyzed cord <NUM> cannot move laterally during respiration, or move medially during speech to close the airway. The incomplete closure of the vocal cords may cause hoarseness, vocal weakness, swallowing difficulties, and breathing disturbances. The IPU may receive physiologic feedback from implanted sensors such as respiration or swallowing muscle or neural signals to modify implant position in real-time coupled to respirations or swallowing such that the implant lateralizes during respiration to open airway yet medialize during swallowing to close airway temporarily to protect from food or fluid aspiration.

Phonosurgery is a procedure involving surgical repositioning of the paralyzed vocal cord to restore vocal activity, usually with injections or implants into the region of the vocal cords. As to be discussed below, the robotic soft-tissue manipulator system <NUM> may be used in a phonosurgery, where the soft-tissue implant <NUM> may be delivered and positioned to interface with the paralyzed cord <NUM>. Through the external control console <NUM>, a surgeon may robotically control the IPU <NUM> to manipulate the soft-tissue implant <NUM>, and modify the position and/or shape of the paralyzed cord <NUM> to restore or improve voice quality.

<FIG> illustrate, by way of example and not limitation, diagrams of implantable positioning units (TPUs) 300A and 300B each coupled to an elongate member <NUM>. The IPUs 300A and 300B each represent an embodiment of the IPU <NUM>, and the elongate member <NUM> represents an embodiment of the elongate member <NUM>.

The IPU 300A illustrated in <FIG> includes a housing <NUM> that encloses electro-mechanical components interconnected to engage the elongate member <NUM> and robotically deliver and position the implant attached to the elongate member <NUM> into a target site. The housing <NUM> may include an entrance and an exit ports to feed the elongate member <NUM> through the IPU 300A. The IPU 300A may include at least two rollers, such as a drive wheel <NUM> and an idler wheel <NUM>, which are embodiments of the coupling unit <NUM> or <NUM>. The drive wheel <NUM> and the idler wheel <NUM> are arranged and configured to engage at least a portion of the elongate member <NUM>. The engagement of the elongate member <NUM> may be through compression between respective radial outer surfaces of the drive wheel <NUM> and an idler wheel <NUM>.

The drive wheel <NUM> may be coupled via a bearing to an axle that is securely attached to the housing <NUM>, such that the drive wheel <NUM> may rotate on the axle without lateral movement relative to the housing <NUM>. The drive wheel <NUM> may be coupled to a motor <NUM> via a power transmission unit <NUM>. The motor <NUM>, which is an embodiment of one of the motor <NUM>, may generate driving force and motion according to a motion control signal provided by the external control console <NUM>. The motor <NUM> may be coupled to the power transmission unit <NUM>, which may be an embodiment of one of the power transmission unit <NUM>. The power transmission unit <NUM> may include gears, pulleys and belts, or timing belts that adjust a speed or torque of the motors. In an example as illustrated in <FIG>, the power transmission unit <NUM> may include a worm gear set <NUM> comprising a worm gear, and a shaft securely coupled to a gearhead of the motor <NUM>. Depending on the motion control signal input to the motor <NUM>, the power transmission unit <NUM> may drive rotation of the drive wheel <NUM>, which in turn propels the implant to a specific orientation or at specific rate.

The idler wheel <NUM> may be coupled to a biasing system that includes a torsion spring <NUM>, a pivot arm <NUM>, and a spring bias <NUM> interconnected to support the second wheel <NUM> and to provide lateral compression against the drive wheel <NUM>. The torsion spring <NUM> may produce spring tension relayed to the second wheel <NUM> via the pivot arm <NUM>, and compress against the drive wheel <NUM> to generate adequate friction on the elongate member <NUM> between the drive wheel <NUM> and the idler wheel <NUM>. Because the idler wheel <NUM> is held in place by the biasing system rather than being affixed to the housing <NUM>, the idler wheel <NUM> may move laterally relative to the housing <NUM>. This may allow for accommodating implants with elongate members of a range of diameters or cross-sectional shapes, while maintaining sufficient friction on the elongate member for desirable movement. In an example, a user may manually bias the torsion spring <NUM> and move the idler wheel <NUM> away from the drive wheel <NUM>, thereby release the compression and open the space between the drive wheel <NUM> and the idler wheel <NUM>. The surgeon may remove the elongate member <NUM> from the IPU 300A, or load another implant with an elongate member into the IPU 300A.

In some examples, the IPU 300A or 300B may enable manual control over the motion of the elongate member <NUM>. At least one roller, such as the drive wheel <NUM>, may be coupled to a manual drive wheel via a transmission unit, such as a gear set including a spur gear, one or more of chains, belts, or shaft couplings, among others. A user may manually access and rotate the manual drive wheel to drive rotation of the drive wheel <NUM>, and frictionally move the elongate member <NUM> at a desired direction and speed. In some examples, the manual motion control discussed herein may be combined with the motorized motion control in the IPU 300A or 300B. For example, the drive wheel <NUM> may be subject to both a robotic control through the motor <NUM> and the power transmission unit <NUM>, and a manual control through the manual drive wheel and the coupled transmission unit. The robotic control and the manual control may be activated independently from each other. In an example, the user interface module <NUM> may enable a user to select between a robotic mode for robotic motion control and a manual mode for manual motion control of the elongate member <NUM>. In an example, the manual mode may take priority over or automatically override the robotic mode. The manual override function may be utilized as a fail-safe emergency stop in case of a fault in the motor <NUM> or the power transmission unit <NUM>.

In some examples, the radial outer surface of the drive wheel <NUM> may be coated with a frictious material, such as a layer of silicone rubber, polymer, or other composite materials. Additionally or alternatively, the radial outer surface of the drive wheel <NUM> may be mechanically textured to have a rough and corrugated surface. The frictious material layer or the corrugated surface finish of the radial outer surface of the drive wheel <NUM> may increase the friction and prevent the elongate member <NUM> from slipping on the drive wheel <NUM> during frictional motion. The radial outer surface of the idler wheel <NUM> may similarly be coated with the frictious material or have a rough surface finish.

Although motorized rollers (including the drive wheel <NUM> and the idler wheel <NUM>) are discussed herein, this is mean to be an illustration rather than a limitation. Other actuating members such as motorized screws, gears, or rack-pinion may alternatively or additionally be used in the systems, apparatus, and methods discussed in this document.

<FIG> illustrates a cross-sectional view 300C of the drive wheel <NUM> and the idle wheel <NUM> with the elongate member <NUM> engaged therebetween. In an example as illustrated in 300C, the elongate member <NUM> has a cylindrical shape or otherwise has a convex cross-sectional profile. The radial outer surface <NUM> of the drive wheel <NUM> and the radial outer surface <NUM> of the idle wheel <NUM> may each have a radially concave profile to allow for secure engagement of the elongate member <NUM>. The concavity of the concave profile, which quantifies a degree of the concave surface, may be determined based on the geometry such as the diameter of the elongate member <NUM>.

The drive wheel <NUM> and the idler wheel <NUM> illustrated in <FIG> may generate one-degree of freedom of movement, such as a translational motion. In some examples, the IPU 300A may include additional wheels or gear sets arranged and configured to translate the force and motion generated from the motor <NUM> into multiple-degrees of freedom movement, as previously discussed with reference to <FIG>. In an example, the IPU 300A may include a gear set to translate the motor motion into a rotational motion of the elongate member <NUM> around its axis. The gear set may include a geared drive wheel coupled to a worm gear coaxially disposed along, and detachably coupled to, a portion of the elongate member <NUM>. The geared drive wheel, when driven to rotate by the motor <NUM> and the power transmission unit <NUM>, may drive rotation of the worm gear, which in turn cause the rotation of the elongate member <NUM> around its axis.

The drive wheel <NUM> and the spring-biased idler wheel <NUM> are an example of the coupling unit by way of illustration and not limitation. An alternative coupling unit may include a geared drive wheel coupled to an implant carrier. The carrier may include an adapter housing placed over and securely hold the elongate member of the implant. The adapter housing may be made of silicone or metal. The carrier may have a linear gear arrangement with teeth configured to engage with the geared drive wheel. The geared drive wheel and the linear gear of the carrier may thus have a rack-and-pinion arrangement, where the geared drive wheel (the pinion) applies rotational motion to the linear gear (the rack) to cause a linear motion relative to the pinion, which in turn may linearly move the elongate member held within the adapter housing of the carrier.

One or more sensors may be attached to the internal components of the IPU 300A, such as the motor <NUM>, the power transmission unit <NUM>, the drive wheel <NUM>, or the spring-biased idler wheel <NUM>. Examples of the sensors may include an encoder or a Hall-effect sensor. The sensors may sense the location or motion of the elongate member <NUM>, or the force or friction applied to the elongate member <NUM>. In an example, a first sensor may be attached to the motor <NUM> to detect the motion of the motor (which indicates the position or motion of the elongate member <NUM>), and a second sensor may be attached to the idler wheel <NUM> to detect the motion of the idler wheel (which also indicates the position or motion of the elongate member <NUM>). The first and second sensors may jointly provide a double check of the implant's position, and can more reliably detect any slippage that may occur between the drive wheel <NUM> and the elongate member <NUM>. For example, if the motor <NUM> functions normally but the elongate member <NUM> slips on the drive wheel <NUM>, the first position sensor on the motor would indicate implant movement, but the second position sensor on the idler wheel <NUM> would indicate no movement or irregular movement of the implant. The external control console <NUM> may include circuitry to detect a discrepancy between the position or motion feedbacks from the first and second sensors. If the discrepancy exceeds a specific threshold, the external control console <NUM> may generate an alert of device fault and presented to the user via the output module <NUM>, or automatically halt the implantation procedure until the user provides instructions to resume the procedure.

The IPU 300A may include a sheath <NUM>. The sheath <NUM> may be attached to a distal end of the housing <NUM>, and extend to a surgical entrance of the target site. The elongate member <NUM> may be flexible and prone to twisting, entanglement, or buckling. The sheath <NUM> may at least partially enclose the elongate member <NUM> to provide resilient support to the elongate member <NUM> of the implant, thereby keeping the implant on track between the housing <NUM> and the surgical entrance of the target site. It may also protect electronics such as an electrode array positioned on the elongate member <NUM> and the conductors inside the elongate member <NUM>.

The sheath <NUM> comprises a flexible tube whose dimensions may substantially match the elongate member <NUM>. For example, the diameter of the tube may be slightly greater than the diameter of the elongate member <NUM>, such that the flexible tube may provide desired rigidity to the elongate member <NUM> inside; while at the same does not produce undue friction between the elongate member <NUM> and the interior surface of the tube. To decrease friction produced by the motion of the elongate member <NUM> relative to the tube during implantation, the sheath <NUM> may be pre-lubricated with a biocompatible and sterilizable lubricant. Alternatively or additionally, the interior surface of the tube may be treated with Polytetrafluoroethylene (PTFE) or linear longitudinal ridges to allow for smooth sliding of the elongate member <NUM> inside the tube.

The distal end of the sheath <NUM> may be fixed or reversibly stabilized at a designated position of the surgical opening of the implantation. The sheath <NUM> may be made of material with low friction, such as plastic or silicone rubber, and biocompatible for tissue contact and compatible with various disposable sterilization methods such as radiation (e.g., gamma, electron beam, or X-ray), or ethylene oxide gas treatment. The sheath <NUM> may be detached from the implant once the implant is positioned at the target site of implantation. In an example, the sheath <NUM> may be composed of two longitudinal halves may be connected with a biocompatible and sterilization-resistant adhesive or sealant. The adhesive or sealant may have an adhesion strength sufficient to hold the two longitudinal pieces together, and may be weakened under a pulling stress. In another example, the disengagement means include peel-away sheath with linear perforations on opposing longitudinal sides to facilitate the tearing of the introducer sheath into two opposing pieces.

In some examples, the IPU 300A may be affixed to the patient or an object in the sterile field of surgery. The components inside the IPU 300A, including the drive wheel <NUM>, the idler wheel <NUM>, the idler wheel biasing system (including the torsion spring <NUM>, the pivot arm <NUM>, and the spring bias <NUM>), and the power system (including the motor <NUM> and the power transmission unit <NUM>), may be made of materials that are both biocompatible and compatible with a specific sterilization method, such as gamma or ethylene oxide. The electro-mechanical components may be made of plastic such as Acrylonitrile-Butadiene-Styrene (ABS), Polycarbonate, Polyetheretherketone, or Polysulfone, among others. The electro-mechanical components may alternatively be made of metal such as stainless steel, cobalt chromium, or titanium, among others.

The IPU 300B as illustrated in <FIG> has a similar structure to the IPU 300A, except that the motor <NUM> is positioned outside the housing <NUM>. The force and motion generated from the motor <NUM> may be transmitted to the drive wheel <NUM> via a flex rotating shaft <NUM> running between the motor <NUM> and the IPU 300B. In an example, the motor <NUM> may be enclosed in standalone housing separated from the IPU 300B and the external control console <NUM>. In another example, the motor <NUM> may be included in or associated with the external control console <NUM>. The flex rotating shaft <NUM> may be integrated with a communication cable linking the IPU 300B and the external control console <NUM>, such that a single cable exits the positioning unit 300B. The communication cable may transmit the sensor feedback on the position or motion of the elongate member <NUM>, or the forces imposed on the elongate member <NUM> such as sensed by one or more sensors on the positioning unit 300B, such as illustrated in <FIG>.

With the exclusion of the motor <NUM>, the IPU 300B may offer several benefits. The IPU 300B may be a smaller, simpler, light-weighted, and low-cost micromechanical device. As the motor <NUM> and associated electrical system are away from direct patient contact and outside of the patient immediate environment, the IPU 300B may offer an increased patient safety. The IPU 300B may be for single use in a sterile surgical field, and is disposable after the surgery. At least due to its small size and lightweight, the IPU 300B may be suitable for fixation on a patient as a stable platform for advancing the implant.

<FIG> illustrate, by way of example and not limitation, a portion of implantable positioning units (IPUs) 400A and 400B each configured to deliver and position a guide sheath and an elongate member <NUM>. The IPUs 400A and 400B expound on the IPUs 300A or 300B illustrated in <FIG>, and can handle positioning of both an elongate member as well as a guide sheath. As illustrated in <FIG>, the IPUs 400A and 400B each include a guide sheath <NUM> that can be fixed to the respective IPU. Within the guide sheath <NUM> is an insertion sheath <NUM> (also referenced as an internal sheath) and the elongate member <NUM>. Compared to the IPUs 300A and 300B, the IPUs 400A and 400B each include two sets of drive and guide wheels, including spring-loaded sheath wheel <NUM> and sheath drive wheel <NUM> and spring-loaded electrode wheel <NUM> and drive wheel <NUM>. The use of the guide sheath <NUM> and the insertion sheath <NUM> serves to reduce the magnitude and frequency of both insertion pressure and insertion forces during the implantation and manipulation of the soft-tissue implant, thereby avoiding trauma to the target soft tissue that may be introduced by manual, un-assisted implantations.

The guide sheath <NUM> may support and internally house an insertion sheath <NUM> in a telescoping fashion. The insertion sheath <NUM> can slide within the guide sheath <NUM> and over the electrode elongate member <NUM> also housed within. The insertion sheath <NUM> moves through the guide sheath <NUM> (affixed to the IPU proximally) and over the elongate member <NUM> on the abluminal side within. This enables controlled robotic movement of both the insertion sheath <NUM> and elongate member <NUM> into the delicate implantation site.

<FIG> illustrates the insertion sheath <NUM> engaged with spring-loaded sheath wheel <NUM> and sheath drive wheel <NUM>, which control positioning of the insertion sheath <NUM>. The elongate member <NUM> is engaged by spring-loaded electrode wheel <NUM> and electrode drive wheel <NUM>. In this example, the insertion sheath <NUM> may be fully positioned, as the IPU 400A is engaged with the elongate member <NUM>. <FIG> illustrates the insertion sheath <NUM> engaged with both drive mechanisms within the IPU 400B. The spring-loaded sheath wheel <NUM> and sheath drive wheel <NUM>, as well as the spring-loaded electrode wheel <NUM> and electrode drive wheel <NUM>, are engaged with the insertion sheath <NUM>. In this example, the insertion sheath <NUM> is still in the process of being positioned/delivered.

The IPUs 400A and 400B may be capable of parallel telescoping or rotational movements of both insertion sheaths <NUM> and <NUM> and the elongate member <NUM> in a coordinated, surgeon controlled fashion utilizing two or more coupling units within the IPU. There may either be two independent drive wheel coupling systems each controlling the sheath and electrode insertion independently or in parallel, coordinated motions. After the end of the internal insertion sheath is inserted a distance that passes the distal coupling unit and travels out of the compressive grasp, the spring-loaded wheel will disengage from the internal insertion sheath and clamp onto the internal electrode implant. The now directly interface implant is then controlled robotically with the same drive wheel control unit via user controlled motion parameters.

<FIG> illustrate, by way of example and not limitation, portions of implantable positioning units (IPUs) 500A and 500B configured to position and maneuver a thyroplasty implant <NUM> to modify the vocal cord position or shape. The IPUs 300A and 500B, which represent embodiments of the IPU <NUM> and expound on the IPUs 300A or 300B illustrated in <FIG>, may each be used in an initial phonosurgery of implantation, or in a revision procedure following the initial implantation. Modification of the vocal cord position or shape may help restore or improve voice quality in patients suffering from vocal cord paralysis, presbylaryngis, or other chronic voice disorders.

The IPU 500A as illustrated in <FIG> includes an electro-mechanical assembly enclosed in a housing <NUM>. The housing <NUM> may be made of a biocompatible material, such as Silastic, goretex, biocompatible metals or polymer. The housing may be attached to a base configured to be affixed to an anatomical structure, such as thyroid cartilage of the voice box, using a fixation member such as screws, pins, nails, wires, hooks, a suture, or a magnet. Similar to the IPUs 300A or 300B, the illustrated portion of the IPU 500A comprises at least a drive wheel <NUM> and an idler wheel <NUM> arranged and configured to engage at least a portion of an elongate member <NUM>, such as through compression between respective radial outer surfaces of the two wheels <NUM> and <NUM>. The IPU 500A includes a motor <NUM> that represents an embodiment of the motor <NUM>. In an example, the motor <NUM> is a piezo stepper motor. The motor <NUM> is electrically connected to a power source, and may generate driving force and motion according to a motion control signal. The motor <NUM> is mechanically coupled to a power transmission unit to transmit the force and motion to the drive wheel <NUM>. In this example, the power source, such as a rechargeable battery or a supercapacitor, may be enclosed in the housing <NUM>. The implantable power source may be charged wirelessly such as through electromagnetic induction or other transcutaneous power means.

Enclosed in the housing <NUM> may include a controller unit <NUM>, which can be implemented on a circuit board that includes one or more of the implantable control circuit <NUM>, the sensor circuit <NUM>, and the transponder <NUM>. The sensor circuit is coupled to an encoder sensor <NUM> configured to sense rotation of the idler wheel <NUM> and to measure various motion parameters associated with the elongate member <NUM>, such as position, distance, or force or friction imposed on the thyroplasty implant <NUM>. Examples of the encoder sensor may include optical, capacitive, inductive, or Hall-effect based sensors.

The thyroplasty implant <NUM> may be made of biocompatible material, such as such as Silastic, goretex, silicon, hydroxyapatite, titanium, or polymer, among other permanent or resorbable materials. The thyroplasty implant <NUM> may be attached to the elongate member <NUM>, such as a distal end of the elongate member <NUM>. The attachment may be detachable, such that once the soft-tissue implant <NUM> has been positioned at the target site, the elongate member <NUM> may be disengaged from thyroplasty implant <NUM>. The detachable design may also allow another elongate member similar to the elongate member <NUM> to attach to a previously implanted thyroplasty implant <NUM>. Alternatively, the thyroplasty implant <NUM> may remain attached to the elongate member <NUM> following the implantation. This allows a surgeon to adjust a pre-existing thyroplasty implant to re-optimize the vocal cord position or shape in a post-implantation revision procedure, yet without the need to reattach the thyroplasty implant <NUM> to the elongate member <NUM>.

In the illustrated example, the thyroplasty implant <NUM> has a wedge shape to conform to the orientation of the vocal cord relative to the positon of the anatomical structure to which the IPU 550A is anchored. The wedge shape may improve tissue contact and flexible tissue manipulation. The thyroplasty implant <NUM> may have an array of piezoelectric actuators with the ability to change shape and contour as needed, as to be discussed in the following in reference to <FIG>. The controller unit <NUM> may monitor the position, motion, shape, or contour of the thyroplasty implant <NUM>, such as via sensors on the thyroplasty implant <NUM> or enclosed in the housing <NUM>, and controllably adjust the contour of the tissue-contacting surface of the thyroplasty implant <NUM> in response to the implant contour control signal received from the external control console <NUM>.

<FIG> illustrates by way of example an alternative IPU design. Instead of having an implantable power source and the controller unit <NUM> enclosed in the housing <NUM>, the IPU 500B includes a second housing <NUM> separated from the housing <NUM>. Enclosed in the housing <NUM> include, among other components, a power source (e.g., batteries or supercapacitors) and a control unit such as the control unit <NUM>. The second housing <NUM> may be electrically coupled to the first housing <NUM> via a communication link <NUM>, such that the power source and the controller unit <NUM> may be electrically connected to the motor <NUM> and the piezoelectric actuators on the thyroplasty implant <NUM>. In an example, the communication link <NUM> may include wires coated with silicon or other biocompatible materials. The two housings <NUM> and <NUM> may be implanted at different body locations. For example, the housing <NUM> may be anchored to thyroid cartilage of the voice box, and the second housing <NUM> may be subcutaneously implanted on a neck or chest site.

<FIG> illustrate, by way of example and not limitation, diagrams of portions of IPU <NUM> for positioning and manipulating a thyroplasty implant <NUM>. The IPU <NUM> may be anchored into a surgically created window through the thyroid cartilage <NUM>, outside the vocal cords. <FIG> illustrates the IPU <NUM> configured to robotically control position of the thyroplasty implant <NUM>. The IPU <NUM> includes a motor and a power transmission system to move a single elongate member <NUM> coupled to the thyroplasty implant <NUM>. The IPU <NUM> is electrically connected to the subcutaneously implantable housing <NUM> that encloses a power source and a control unit, as discussed above with reference to the systern 500B. The shape of the thyroplasty implant <NUM> as it projects into the surgically created window can be oblique with more projection posteriorly than anteriorly. This is to address the average amount of induced medial projection of the vocal cord, which can be approximately <NUM> anteriorly and <NUM> posteriorly. The thyroplasty implant <NUM> may be positioned such that it interfaces with the target vocal cord <NUM>, such as a paralyzed vocal cord. The IPU <NUM> may robotically adjust the position and shape of the thyroplasty implant <NUM>, thus push (medialize) the paralyzed vocal cord <NUM> toward the middle of the vocal box to improve vocalization, or pull (lateralize) the paralyzed vocal cord <NUM> farther away from the middle of the vocal box to weaken vocal cord closure or to enlarge glottis aperture to improve airway opening and ventilation.

The IPU <NUM> includes a set of motors configured to provide various modes of motion of the elongate member <NUM>, including translational advancement or withdrawal. and rotational motion such as flexion and extension. <FIG> illustrates the IPU <NUM> that engages multiple elongate members, such as 602A-602C. The IPU <NUM> may include a set of electric motors configured to independently drive motion of respective elongate members 602A-602C, such as at different directions (e.g., forward or backward) and/or with different speeds. With the independent control of multiple elongate members, the thyroplasty implant <NUM> may not only move linearly as a whole, but may also slant or rotate at different angles, thus increasing the flexibility of altering the vocal cord position and conformation.

The IPU <NUM> may be affixed to the thyroid cartilage <NUM> using affixation means, such as one or more screws <NUM>. Other fixation means may also be used, such as one or more of a pin, a nail, a wire, a hook, a barb, a helix, a suture, a glue, or a magnet within the IPU <NUM> coupled to one or more magnetic screws or pins affixed to the body part of the patient <NUM>. <FIG> illustrates a diagram of affixing the IPU <NUM> on the thyroid cartilage <NUM> further using a surgical mesh <NUM> permitting suture fixation to the cartilage adjacent to the window, such as to provide further support and stabilization of the IPU <NUM>. The surgical mesh <NUM> may be made of polypropylene, polymer, goretex, Teflon, or titanium, among other biocompatible materials. In various examples, the fixation means may include one or more of self-drilling screws, self-tapping screws, or self-piercing screws, such that no pilot hole needs to be drilled at the affixation site prior to screw installation. <FIG> illustrates a diagram of self-piercing curved projections <NUM> such as barbs or helices that can be extended from one or more outer surfaces of the IPU <NUM>, and pierce through the thyroid cartilage <NUM> to support and stabilize the IPU <NUM> on the anchoring cartilage. By way of example and not limitation, the self-piercing curved projections <NUM> may be coupled to respective screws <NUM>. A user may rotate the respective screws <NUM>, such as by using a screwdriver, to cause projection or retraction of the curved projections.

The IPU <NUM> and the associated thyroplasty implant <NUM> may be used to control the positioning of the vocal cord <NUM> not only during initial implantation, but also in revision procedures without further surgical incision. In the event of device exchange, the elongate member <NUM> may be disengaged from the IPU <NUM>, and the IPU <NUM> may be removed from the thyroid cartilage <NUM>. The thyroplasty portion, including the elongate member <NUM> and the attached thyroplasty implant <NUM> may remain in place. A new IPU may be surgically implanted, affixed to thyroid cartilage <NUM>, and reconnected with the elongate member <NUM> and the thyroplasty implant <NUM>.

<FIG> illustrate, by way of example and not limitation, a soft-tissue implant <NUM> having an array of micro-actuators that can modify position and shape of a target soft tissue. The soft-tissue implant <NUM> is an embodiment of the soft-tissue implant <NUM> illustrated in <FIG>, and may be coupled to an IPU, such as one of the IPUs 300A-300B or 500A-500B, via an elongate member <NUM>. A surgeon may use the IPU to controllably modify the position and shape of a paralyzed vocal cord in a phonosurgery.

As illustrated in <FIG>, the soft-tissue implant <NUM> may include an array of piezoelectric, pneumatic, or hydraulic micro-actuators <NUM> configured to change the contour of at least a tissue-contacting surface of the soft-tissue implant <NUM>. The micro-actuators <NUM> may be securely attached to the target soft-tissue such that the target soft tissue may be repositioned in different directions, such as medialization and future lateralization of a vocal cord as discussed above in reference to <FIG>. In an example, the attachment of the micro-actuators <NUM> to the target soft-tissue is achieved using suture holes or other active fixation mechanisms. In another example, the micro-actuators <NUM> may be enclosed or encapsulated in a biocompatible material that is capable of tissue ingrowth and integration. The capacity of the soft-tissue implant <NUM> to not only push (medialize) the vocal cord but also to pull (lateralize) and to shape the vocal cord provides a large number of applications for thyroplasty including but not limited to glottic incompetence arising from vocal cord paralysis. Additionally, the soft-tissue implant <NUM> may be used as a tissue expander to provide gradual expansion of the vocal cord attended by stimulated cellular growth will permit remodeling of scarred and distorted vocal cord tissue to improve its vibratory capacity and voicing result.

In accordance with an implant contour control signal, the micro-actuators <NUM> may be actuated to change the tissue-contacting surface contour. The change of the tissue-contacting surface contour may cause changes of the position or shape of at least a portion of the target soft tissue. In an example, the micro-actuators <NUM> are an array of piezoelectric actuators that may be powered via an implantable power source, such as one included in the IPU (e.g., enclosed in the housing <NUM>), or a power source enclosed in a separate subcutaneously implanted housing (such as the housing <NUM>). Alternatively, the micro-actuators <NUM> may be powered transcutaneously such as via inductive means. In case of piezoelectric actuators, in accordance with an implant contour control signal, a voltage map specifying voltages for the respective piezoelectric actuators may be generated and applied to respectively to the piezoelectric actuator array <NUM>. Physical dimensions of the piezoelectric actuator array <NUM> may change in proportion to the applied voltage. Similarly, the hydraulic or pneumatic pressures can be controlled to change in proportion to applied commands. As a result, a unique contour or topography may result on the tissue-contacting surface of the soft-tissue implant <NUM>. The soft-tissue implant <NUM> is capable of conformational changes in multiple axis and degrees of freedom (anterior, posterior, medial, lateral). <FIG> illustrate respectively a top view and a side view of a portion of the piezoelectric actuator array <NUM> when different voltages are applied to individual piezoelectric actuators. In this example, actuators <NUM> at one region of the surface less deformed than actuators <NUM> at another region of the tissue-contacting surface. Such a change in physical dimension or topography of the piezoelectric actuator array <NUM> accordingly change the shape and position of the target soft-tissue interfacing with the piezoelectric actuator array <NUM>. In an example of vocal cord modification, the implantable control circuit may dynamically change the applied voltage, thereby modifying the physical dimensions of the implant surface. As such, a multidimensional surface topography can be defined by the user (e.g., a surgeon) in order to optimize vocal cord position and shape, and voice quality to match the contralateral healthy vocal cord points of contact.

<FIG> illustrates, by way of example and not limitation, a block diagram of a portion of an external control system <NUM> to control an IPU to robotically position and manipulate a soft-tissue implant, such as a thyroplasty implant for modifying position and shape of a vocal cord. The external control system <NUM> comprises an external control console <NUM> coupled with one or more peripheral devices for implant motion control. The external control console <NUM>, which represents an embodiment of the external control console <NUM> illustrated in <FIG>, may include a user interface module <NUM>, a memory circuit <NUM>, a voice analyzer <NUM>, and a controller circuit <NUM>. These circuits may, alone or in combination, perform the functions, methods, or techniques described herein. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. Alternatively, the external control console <NUM> may be implemented as a part of a microprocessor circuit, which may be a dedicated processor such as a digital signal processor, application specific integrated circuit (ASIC), microprocessor, or other type of processor. Alternatively, the microprocessor circuit may be a general purpose processor that may receive and execute a set of instructions of performing the functions, methods, or techniques described herein.

The controller circuit <NUM>, which represents an embodiment of the controller circuit <NUM>, may include an implant motion control module <NUM> for macro soft tissue position adjustment, and an implant contour control module <NUM> for micro soft tissue position adjustment. The implant motion control module <NUM> is configured to generate an implant motion control signal to control the power system of the IPU to regulate movement rate, a movement direction or orientation, a movement distance, a position of a distal end of the elongate member, or an amount of force imposed on the elongate member <NUM>, among others. The implant contour control module <NUM> is configured to generate an implant contour control signal for controlling the piezoelectric actuator array such as by applying a voltage map to change tissue-contacting surface contour, thereby causing changes in shape or position of the target soft tissue.

In an example, the controller circuit <NUM> may receive real-time remote sensor data transmitted from the IPU and the soft-tissue implant, and dynamically control the macro- and micro-positioning of the soft-tissue implant using a feedback-control method. For example, the sensor feedback analyzer <NUM> may receive sensor information sensed by the sensor circuit <NUM> within the IPU <NUM>, including position or motion of the soft-tissue implant during the implantation and positioning process, and force or friction imposed on the soft-tissue implant. The sensor feedback analyzer <NUM> may additionally receive sensor information about the shape, contour, or topography of the tissue-contacting surface of the soft-tissue implant, such as before and after applying voltage to the micro-actuators on the tissue-contacting surface of the implant. The sensor feedback analyzer <NUM> may then adjust the implant motion control signal or the implant contour control signal based on one or more of sensor feedback including physiologic respiratory and swallowing signals from muscle or neural feedback sensors.

The voice analyzer <NUM> may be configured to analyze patient voice quality during the implantation or revision procedure when the patient is instructed to vocalize during the procedure. A microphone coupled to the interface module <NUM> may acquire patient voice, which is analyzed by the voice analyzer <NUM> to provide an indication of improvement in voice quality. indication of voice quality improvement may be used as feedback by the controller circuit <NUM> to generate the motion control signal to adjust the position and motion of the soft-tissue implant, and/or to generate the implant contour control signal to adjust the contour and topography of the tissue-contacting surface of the soft-tissue implant, thereby modifying the position and shape of the target soft-tissue.

The peripheral devices may include one or more of a foot pedal <NUM>, or a handheld device <NUM>. In an event that the motor and the power system are included within the IPU, the one or more peripheral devices may be communicatively coupled to the IPU to directly control the motor output. The one or more peripheral devices may be communicatively coupled to the controller circuit <NUM> of the external control console <NUM>, such as via a wired connection or a wireless communication link. Compared to the external control console <NUM>, the peripheral devices may have smaller size, lighter weight, and more mobility, thereby may provide enhanced operation flexibility. Some peripheral devices, such as a foot pedal, may be reusable. The materials need not be sterilizable or biocompatible to the level at which the IPU materials do.

The foot pedal <NUM> may provide the surgeon with the means to control the motion of the implant. The foot pedal may be positioned under the patient table, accessible to the surgeon. The foot pedal <NUM> may comprise a motion control input <NUM>. In an example, the motion control input <NUM> may include two or more pedals for use to control lead motion at different directions, such as one pedal to activate forward advancement motion, and another pedal to activate retraction motion to fine-tune the implant position or for implant extraction. In another example, the motion control input <NUM> may include two or more pedals for use to control lead motion at different lead orientation, such as one pedal to control the translational motion, and another pedal to control the rotational motion. In yet another example, the motion control input <NUM> may include one pedal used for controlling implant advancement, and another pedal used for resetting the current implant position (i.e., setting the current position to zero). If a retraction action is needed, this may be an input on the external control console <NUM>, where the retraction command may be generated from the external control console <NUM>. This would prevent accidental retraction of the implant by stepping on the wrong pedal.

In some examples, each foot pedal may be incorporated with one or more command buttons or switches that are programmed for different functions, such as for controlling various motion parameters including motion rate, motion distance, or amount of force applied to the implant during insertion. In an example, different motion control actions may correspond to programmed duration when pedal is pressed and held, or patterns of the pedal press (such as one press, double press, or a combination of short and long press). For example, a short press may set the current implant position to zero (i.e., position reset), and a long press (e.g., press and hold for at least three seconds) may advance the implant. In an example, one press or button push may correspond to a specific distance of movement, such as <NUM> microns during an implantation procedure. In another example, the rate of insertion or the distance of the movement may vary based on a degree of foot pedal displacement up to the maximum set insertion rate and distance as programmed by a user via the user interface module <NUM>.

The handheld device <NUM> may include a motion control input <NUM>, such as buttons, switches, or other selection and activation mechanisms to control one or more motion parameters of the implant. As illustrated in <FIG>, the communication circuit <NUM> may be implemented inside the handheld device <NUM>. In an example, the communication circuit <NUM> may communicate with the IPU <NUM> via a wireless communication link, including transmitting the motor control signal to the motor <NUM>, and receive sensor feedback from one or more sensors located at the power system <NUM> or the IPU <NUM>. The mobility of the handheld device may allow for enhanced reliability of wireless communication. In some examples, the handheld device <NUM> may include a charger circuit <NUM> for wirelessly charging a power source for powering up the motor such as located inside the IPU.

<FIG> illustrates, by way of example and not limitation, a method <NUM> for positioning a soft-tissue implant into a target implantation site via a robotically assisted and dynamically controlled tissue manipulator system, such as the robotic soft-tissue manipulator system <NUM>. In an example, the method <NUM> may be used to operate the robotically controlled tissue manipulator system to position and manipulate a thyroplasty implant (such as the those illustrated in <FIG>) inside patient voice box. The thyroplasty implant may interface with a vocal cord, and alter the position or shape of the vocal cord to treat or alleviate symptoms of voice disorders such as due to vocal cord paralysis or presbylaryngis. The method <NUM>, or a modification thereof, may alternatively be used to operate the robotically controlled tissue manipulator system to deliver, steer, position, modify, or extract other types of implants or prosthesis. Examples of such implants may include leads, catheter, guidewire, or other mechanical or electrical devices. The implants may be used for diagnosing a disease or other conditions, or alternatively or additionally be used in the cure, mitigation, treatment, or prevention of disease, such as implantable electrodes for delivering electrostimulation at cardiac, neural, muscular, or other tissues.

The method <NUM> commences at step <NUM>, where the soft-tissue implant may be engaged to an implantable positioning unit (IPU), such as the IPU discussed above with reference to <FIG>. The IPU includes mechanical and electrical components for controlling the motion of the implant. The soft-tissue implant may be coupled to an elongate member detachably engaged to the IPU via a coupling unit. The coupling unit may include motorized actuation via rollers, screws, gears, or rack-pinion, among others. In an example, the coupling unit may comprise a set of rollers including a drive wheel and an idler wheel arrangement as illustrated in <FIG>. The elongate member may be fed through the IPU via an entrance port and an exit port, and compression-engaged between the driver wheel and the idler wheel. The idler wheel may be spring-biased and compress against the driver wheel, via a torsion spring. In some examples, the torsion spring may be manually biased to release the compression and open the space between the drive wheel and the idler wheel to accommodate the elongate member into the IPU.

At <NUM>, the IPU may be implanted and affixed to an anatomical structure. In an example of robotic positioning a thyroplasty implant to adjust position and shape of a vocal cord, the IPU <NUM> may be anchored to patient thyroid cartilage, as illustrated in <FIG>. Various electrical and mechanical component of the IPU may be enclosed in a housing made of biocompatible materials, such as Silastic, goretex, biocompatible metals or polymer. The IPU may be sized and shaped to facilitate affixation. The IPU may include a fixation member, such as one or more of a screw, a pin, a nail, a wire, a hook, a barb, a helix, a suture, or a magnet. Additionally or alternatively, the fixation member may include one or more of self-drilling screws, self-tapping screws, or self-piercing screws. The IPU may have an exterior contact surface with a rough texture, or equipped with one or more gripping elements, such as spikes, pins, or barbs protruding from the exterior surface that can provide sufficient friction or gripping force to stabilize the IPU on the anchoring tissue. In some examples, the electrical and mechanical components of the IPU <NUM> may be packaged into separate housings that can be anchored to different anatomical structures, as illustrated in <FIG>.

At <NUM>, a communication link is established between an IPU and an external control console, such as the external control console <NUM>. The communication link may include a wired connection or a wireless connection, such as a Bluetooth protocol, a Bluetooth low energy protocol, a near-field communication (NFC) protocol, Ethernet, IEEE <NUM> wireless, an inductive telemetry link, or a radio-frequency telemetry link, among others. The external controller console may include dedicated hardware/software system that can robotically control the IPU to propel the elongate member at specific rate, direction, or distance, thereby positioning the soft-tissue implant at the target site. The external control console may additionally receive information acquired by sensors within the IPU, or measurement data from external systems that can be directly related to implant position.

At <NUM>, the soft-tissue implant may be positioned into the target site through the robotic control of the IPU. The external control console may generate an implant motion control signal according to the motion control instructions provided by the user. In response to the motion control signal, the IPU <NUM> may move the soft-tissue implant at specific movement rate, movement direction or orientation, or distance. The IPU <NUM> may additionally or alternatively control the amount of force imposed on the elongate member. In some examples, the motion control signal may control multiple motors configured to drive different modes of motion (e.g., translational or rotational motions) on the same elongate member, or to drive different elongate members, as illustrated in <FIG>.

Once the soft-tissue implant has been positioned at the target site and interfaces with the target soft-tissue, the soft-tissue implant may be securely attached to the target soft tissue, such as using suture holes or other active fixation mechanisms. Biocompatible material may be used at the soft tissue interface to promote tissue ingrowth and integration. In the example of vocal cord modification via a thyroplasty implant as illustrated in <FIG>, such a secure attachment allows the soft-tissue implant to not only push (medialize) the vocal cord to restore or improve glottic incompetence arising from vocal cord paralysis and thus to improve vocalization, but also to pull (lateralize) the vocal cord to weaken vocal cord closure or to enlarge glottis aperture to improve airway opening and ventilation. After the attachment of the implant to the target soft tissue, the implant may remain attached to the elongate member. This allows for post-surgical adjustment of the position of soft-tissue implant (e.g., revision of an existing thyroplasty implant to adjust vocal cord position or shape), yet without the need to reattach the soft-tissue implant to the elongate member.

At <NUM>, the shape or physical dimension of at least a portion of the soft-tissue implant may be controllably adjusted to alter the position or shape of at least a portion of the soft tissue. The soft-tissue implant may include an array of micro-actuators configured to change the contour of the implant surface that interfaces with the soft-tissue, as illustrated in <FIG>. The micro-actuators may be based on voltage-controlled piezoelectric materials. In response to an implant contour control signal received from the external control console, the IPU may activate the micro-actuators can alter the tissue-contacting surface contour, thereby causing changes in shape or position of the target soft tissue.

The method <NUM> discussed herein may be used for initial implantation of the IPU for soft-tissue implant deployment and positioning. The method <NUM> may be modified for use in a revision procedure to modify an existing soft-tissue implant. As the IPU may have been implanted in the initial implantation and coupled to the soft-tissue implant, the method <NUM> may instead begin at <NUM> to establish a communication between an external control console and the implanted IPU, and robotically move the implant or alter the tissue-contacting surface contour to re-optimize the position and conformation of the target soft tissue, such as medializing or lateraling a vocal cord to improve vocalization. A wireless communication between the external control console and the previously implanted IPU allows a surgeon to perform non-invasive, transcutaneous control of implant position and conformation to optimize patient vocal quality as age and other factors cause the laryngeal anatomy to evolve over time.

<FIG> illustrates, by way of example and not limitation, a method <NUM> for robotically controlled positing and manipulation of a soft-tissue implant. The method <NUM> is an embodiment of the steps <NUM> and <NUM> of the method <NUM> as illustrated in <FIG>. In an example, the method <NUM> may be used to operate the robotically controlled tissue manipulator system to position and manipulate a thyroplasty implant based on at least sensor feedback on the position of the implant, motion the implant, or the force or friction applied to the implant, and/or other patient physiologic responses such as respiration or muscle electrical signal.

Once the IPU is implanted and fixed and the communication established between the IPU and the eternal control console, a user may program one or more motion control parameters at <NUM>, such as via the user interface module <NUM> of the external control console <NUM>. The motion control parameters may characterize desired motion of the elongate member of the implant. Examples of the motion parameters may include a target movement rate, a target movement direction or orientation, a target movement distance, a target position of a distal end of the elongate member, or a target amount of force imposed on the elongate member. In addition to the motion control parameters, a user may program one or more implant contour control parameters at <NUM>. The implant contour control parameters may include desired contour or topography of the tissue-contacting surface of the soft-tissue implant or a voltage map specifying voltages to be applied to respective piezoelectric actuators to produce the desired contour or topography of the implant surface. In some examples, a predetermined implant delivery protocol may be programmed into the system. The implant delivery protocol defines target values of a plurality of motion parameters. A user may adjust one or more motion control parameters or contour control parameters, modify an existing implant delivery protocol, or switch to a different implant delivery protocol during the implant delivery procedure.

Following the programming of motion and contour control parameters, the soft-tissue implant may be robotically advanced via the control console or one or more of the peripheral input controls coupled to the control console. At <NUM>, the current implant position may be reset to zero, such as by a short press of the foot pedal. At <NUM>, the implant may be positioned to the target site in accordance with the programmed motion control parameters. The motion of the implant may be activated by a surgeon using the control buttons on the control console, or a peripheral control device, such as a foot pedal or a handheld device. The movement of the implant may be activated at intervals of a predetermined step size. In an example of implantation of a thyroplasty implant, the target movement distance may range from <NUM> - <NUM> millimeter (mm). The target movement rate is approximately at <NUM>-micron intervals.

During positioning and manipulation of the soft-tissue implant, one or more sensors may sense information about position and motion of the implant at 1044A. The sensor may be positioned at the motor, the power transmission unit, or inside the IPU such as at the drive wheel or idler wheel. In addition to impla nt position and motion information other sensor information about the shape, contour, or topography of the tissue-contacting surface of the soft-tissue implant, such as before and after applying voltage to the micro-actuators, may also be acquired.

Additionally or alternatively, patient physiologic signals may be sensed at 1044B during the implant positioning and manipulation. In an example of implantation or revision of a thyroplasty implant, intraoperative patient voice feedback may be acquired using a microphone coupled to the interface module <NUM>. Voice quality may be analyzed to provide an indication of improvement in voice quality.

At <NUM>, the sensor feedback on implant position, motion, shape and contour, and the patient physiologic signal may be transmitted to the control console and output to a user or a process. In an example, a human-perceptible presentation of the sensed feedback, including one or more parameters on the position of the implant, motion of the implant, or the force or friction applied to the implant motion, may be generated. The presentaton may include real-time visual or audible notification with specified patterns corresponding to different types of events encountered during implantation. The audible and visual feedback may also signal to the user that the sensed implant position, motion, or the forces has exceed the target parameter values such as programmed by the user.

The sensed implant information and patient physiologic signal may be used as feedback to generate the motion control signal to adjust the position and motion of the soft-tissue implant. At <NUM>, the sensor feedback and/or patient physiologic response may be checked to determine whether target site has been reached. In an example, a target site is reached if the sensed distance of insertion reaches the user programmed target distance within a specified margin. A visual indicator, such as a light emitting diode (LED) or an on-screen visual indicator on the display screen with specified color or pattern may signal to the user a successful positioning of the implant at the target site. Alternatively or additionally, an audial notification, such as a beep or an alarm with a specific tone, frequency, or a specific pattern (e.g., continuous, intermittent, pulsed, sweep-up, or sweep-down sound) may go off to signal to the user successful positioning of the implant at the target site.

If the target site is not reached, then the delivery and positioning process may be continued at <NUM>. If at <NUM> it is determined that the target site has been reached, then at <NUM>, a voltage map may be applied to piezoelectric actuators on the implant. The micro-actuators may be based on voltage-controlled piezoelectric materials, such that the physical dimensions of the piezoelectric actuator array may change in proportion to the applied voltage. The voltage map specifies voltages respectively applied to the piezoelectric actuators to change tissue-contacting surface contour, thereby causing changes in shape or position of the target soft tissue. The soft-tissue implant is capable of conformational changes in multiple axis and degrees of freedom (anterior, posterior, medial, lateral), as illustrated in <FIG>.

The sensed implant contour parameters at 1044A and the sensed patient physiologic signal at 1044B may be used as feedback to generate an implant contour control signal to adjust the contour and topography of the tissue-contacting surface of the soft-tissue implant, thereby modifying the position and shape of the target soft-tissue. At <NUM>, the sensor feedback and/or patient physiologic response may be checked to determine whether the target soft tissue has reached a desired position and shape. In an example of thyroplasty for vocal cord adjustment, a desired position and shape is reached if patient intraoperative vocalization attains a specific quality. If no ideal tissue position or shape is reached, then the voltage map may be adjusted to continue modifying the shape of the contacting surface of the implant at <NUM>. If at <NUM> it is determined that ideal tissue position or shape is reached, then at <NUM>, the implant positioning and modification process terminates. For an initial implantation, the surgical opening for IPU implantation can be closed. If it is a post-surgical implant revision procedure, the communication between the IPU and the external control console may be disconnected.

<FIG> illustrate, by way of example and not limitation, diagrams of different views of an implantable positioning unit (IPU) <NUM> for engaging an elongate member, such as the elongate member <NUM> or the elongate member <NUM>. The IPU <NUM> is a variant of the IPU 300B, which can be used to robotically deliver and position an implant attached to the elongate member into a target site or to manipulate soft tissue, such as a cochlear or a vocal cord.

<FIG> illustrates a three-dimensional external view of the IPU <NUM>. <FIG> and <FIG> illustrate respectively a cross-section view and a sideview of the IPU <NUM><NUM>. Similar to the IPU 300B, the IPU <NUM> includes a power system contained in a separate housing than a coupling unit (comprising a drive wheel and an idle wheel) for engaging the elongate member. The power system comprises a motor and motor control circuitry that provide driving force to the coupling unit. As illustrated in <FIG>, the IPU <NUM> includes a slidable control box <NUM> and an implant drive head <NUM>. The slidable control box <NUM> includes a case <NUM>, a sliding member <NUM>, a case lock <NUM>, and a base mount <NUM>. The sliding member <NUM> allows for user gripping and sliding the slidable control box <NUM> linearly for optimal placement of the slidable control box <NUM> on an anatomical surface (e.g., patient skull). The case lock <NUM>, which can be a toggle switch located on both sides of the case <NUM>, can lock or unlock the slidable control box <NUM> at a position when pressed The base mount <NUM> can be sized and shaped to conform to the anatomical surface, and can include anchoring members (e.g., self-tapping, captive bone screw holes) that secure the slidable control box <NUM> thereon. In some examples, the base mount <NUM> can be C-shaped to hold and compress the sliding case <NUM> therein. This allows linear movement and increased travel range of the slidable control box <NUM> and drive head <NUM> for optimal positioning of the drive head <NUM> and varying anatomical sizes.

As illustrated in <FIG>, enclosed within the case <NUM> includes an electric motor <NUM> that can generate driving force and motion, and a motor controller <NUM> (e.g., a printed circuit board) that can generate motion control signal to control movement of the electric motor <NUM>. The electric motor <NUM> and the motor controller <NUM> may be respectively connected to a power source and an external control computer via a power/communication cord <NUM>, such as a USB cable.

The implant drive head <NUM> can be connected to the slidable control box <NUM> via an adjustable arm <NUM>, such as an adjustable Gooseneck arm. The adjustable arm <NUM> can be a flexible, semirigid arm that allows for multiple depth-of-field (DOF) adjustment of the drive head <NUM> at multiple, different angles to the insertion implant site, providing adjustable stability of the drive head <NUM>. In an example, the adjustable arm <NUM> can be bended to adjust the position of the implant drive head <NUM>. This allows for easy advancement of the elongate member and the associated implant into the target site (e.g., cochlea or vocal cord).

The implant drive head <NUM> includes a drive housing <NUM> that can house drive mechanism, an introducer sheath, and sheath components. <FIG> illustrates a cutaway view of the implant drive head <NUM>. The drive housing <NUM> comprises two symmetrical housing halves interconnected via a hinge <NUM>. The hinge <NUM> allows for opening and closing of the drive housing <NUM> to engage and disengage with the elongated member or electrode of varying sizes, geometry, and diameter. In some examples, one or more backstops <NUM> can be included inside the drive housing <NUM> to prevent the elongate member or the electrode therewith from reaching the hinge <NUM> during engagement, thereby prevening inadvertent damage to the elongate member or the electrode therewith.

The drive mechanism inside the drive housing <NUM> includes a drive wheel <NUM> and an idle wheel <NUM>, and can include a torsion spring <NUM>. As similarly discussed above such as with reference to <FIG>, the drive wheel <NUM> rotates to insert or retract elongate member through sheath, and the idle wheel <NUM> rotates to keep the elongate member aligned with the drive wheel <NUM>. A drive pin <NUM> may be included to improve smooth rotation of the drive wheel <NUM>, and an idle pin <NUM> may be included to improve smooth rotation of the idle wheel <NUM>. As illustrated in <FIG>, torque may be transmitted from the electric motor <NUM> to the drive wheel <NUM> via a torque cable <NUM>, at least a portion of which can be enclosed in the adjustable arm <NUM>. The torsion spring <NUM> allows the drive head <NUM> to open and close, and provides compression on the elongate member for frictional motion.

The implant drive head <NUM> includes a sheath <NUM> that provides lateral and peripheral support to move the flexible elongate member inside the sheath <NUM>. In an example, a loading access <NUM>, such as a slit or notch, can be included in the sheath <NUM> for accessing and loading the elongated member into the drive head <NUM> after the housing halves are closed. A distal end of the sheath <NUM> opens to form a guide track slot, which can be a specially shaped tip to control final orientation of the implant placement based on the implant geometry.

Various embodiments are illustrated in the figures above. One or more features from one or more of these embodiments may be combined to form other embodiments.

The method examples described herein can be machine or computer-implemented at least in part. Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform methods as described in the above examples. An implementation of such methods may include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code may include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.

Claim 1:
A system (<NUM>) for robotically assisted manipulation of an implant (<NUM>), the system comprising:
a drive head (<NUM>) configured to engage an elongate member (<NUM>; <NUM>) of the implant and robotically deliver and position the implant into a target implantation site, the drive head including:
a housing (<NUM>) including a first half and a second half, the first half coupled to the second half with a hinge (<NUM>), to enable the housing to receive the elongate member;
a sheath (<NUM>) including separable first and second portions associated respectively with the first and second halves of the housing (<NUM>), the separable first and second portions of the sheath forming a guide track configured to accommodate and channel the elongate member (<NUM>; <NUM>) in a linear motion; and
a coupling unit including a drive wheel (<NUM>) and an idle wheel (<NUM>) disposed respectively within the first and second halves of the housing (<NUM>), the coupling unit configured to translate the elongate member (<NUM>; <NUM>) using the wheel within the guide track, in response to a motion control signal;
a power system coupled to the coupling unit, the power system including a motor (<NUM>) and motor control circuitry (<NUM>) positioned within a case (<NUM>) and configured to drive the drive wheel (<NUM>) of the coupling unit; and
a control console (<NUM>; <NUM>) communicatively coupled to the power system, the control console including a controller circuit (<NUM>) configured to generate the motion control signal, to robotically deliver and position the implant into the target implantation site,
wherein the guide track includes a first longitudinal track portion and a second longitudinal track portion, the first longitudinal track portion defined by the first half of the housing and the second longitudinal track portion defined by the second half of the housing.