Patent Description:
Surgical instruments and entry guides that are able to follow a natural lumen or other convoluted paths generally must be flexible, which requires these devices to have properties and abilities that are not needed in most other surgical instruments. In particular, although an entry guide must be flexible enough to navigate a convoluted path, the guide ideally should provide a stable base at the work site for manipulation of an instrument or instruments inserted through the guide. Additionally, the guide should not change shape or react to external forces in a manner that could unintentionally damage adjacent tissue. Cables or tendons may extend through all or part of an entry guide for actuation of mechanical features of the entry guide or steering of the entry guide along its path. In some advanced surgical systems, these cables are robotically operated using motors and computer aided control. (As used herein, the terms "robot" or "robotically" and the like include teleoperation or telerobotic aspects. ) The forces applied through the tendons can be significant, both to overcome friction and because the lengths of entry guides and instruments can create long moment arms. A flexible surgical device needs to control these relatively large forces so that reactions or movements along the length of the device do not damage the adjacent tissue of the patient.

<CIT> discloses a steerable shaft of a medical instrument is steered by one or more control cables. The control cables are in contact with a steering system tension control device that alters the tension in the control cables caused by bends in the shaft.

<CIT> discloses drive systems and methods of use for performing medical procedures on a patient. The drive systems include handle types and triggers for controlling catheters and end effectors. The various handle types include a flexible handle and ambidextrous handles that can alter the handedness of the handle for use. The handles drive articulation sections of the catheter and end effectors with various degrees of freedom, and include locks for holding the catheter and/or end effector in place. The catheter systems include structures for allowing degrees of freedom, such as notches, mechanical interlocks, and articulation joints.

The present invention provides a surgical device as set out in the appended independent claim. Optional features are set out in the appended dependent claims. In an example, a compliant surgical device such as an articulated entry guide employs tendons to operate or steer the device and attaches constant force spring systems to control tension in the tendons. As a result, the surgical device can be compliant and respond to external forces during a surgical procedure without rapidly springing back or otherwise causing a reaction that damages tissue. The compliance also permits manual positioning or shaping of the device during or before insertion for a surgical procedure without damaging the tendons or connections of the tendons within the device or causing damage to a backend mechanism.

A further example is a surgical device such as an entry guide. The device includes a shaft having a movable member, a tendon attached to the member, a constant force spring system, and a control mechanism. The constant force spring system is attached to the tendon, and the control mechanism controls the magnitude that the constant force spring system applies to the tendon. The tension in the tendon can thus be independent of external forces moving the tendon but controlled to articulate the member.

Another example is also a surgical device. This embodiment includes a shaft having a movable member, a tendon attached to the member, and an asymmetric spring system attached to the tendon. The asymmetric spring system is such that a force applied by the asymmetric spring system to the tendon has greater dependence on a location of a proximal end of the spring system than on a location of the tendon. A control mechanism can be connected to the proximal end of the asymmetric spring system.

Yet another example is a method for operating a surgical device. The method includes inserting an articulated shaft of the surgical device for a surgical procedure, and using asymmetric or constant force spring systems to maintain balancing forces on members of the articulated shaft.

Use of the same reference symbols in different figures indicates similar or identical items.

Compliance in an articulated surgical device such as a flexible entry guide is generally desirable to permit manual shaping of the device. In accordance with an aspect of the invention, tendons that connect to portions (e.g., mechanical links or vertebrae) in the flexible device to a backend mechanism are connected to spring systems that can accommodate manual manipulation of the flexible portion of the device without damaging the backend mechanism or connections of the tendons. In accordance with a further aspect of the invention, the spring system coupled to the drive tendons is asymmetric or even a constant force spring, so that the spring system does not cause large reaction forces and the device does not rapidly spring back in response to external forces. The compliance of the surgical device and the lack of spring back may help to avoid tissue damage which might otherwise be caused during a surgical procedure when the flexible device could be subject to changing external forces.

<FIG> illustrates a flexible entry guide <NUM> in accordance with an embodiment of the invention. Entry guide <NUM> includes a flexible main tube <NUM> and a backend mechanism <NUM> at the proximal end of main tube <NUM>. Main tube <NUM> is flexible in that main tube <NUM> can bend as needed to follow a convoluted path, but main tube <NUM> may include a series of rigid links or mechanical members that can act as articulated vertebrae to change the shape of main tube <NUM>. Some exemplary articulated structures suitable for main tube <NUM> are described in U. No. <CIT>; and U. Additionally, the articulated structure in an entry guide can employ some of the same architectures found in articulated wrists and similar robotic mechanism such as described in <CIT>; U. No. <CIT>; and <CIT>. A compliant sheath made from a rubber or plastic such as neoprene, pellethane, FEP, PTFE, Nylon, or similar material can cover the links and other internal structure of main tube <NUM> to provide a sealed enclosure for the internal mechanisms of the entry guide and to facilitate insertion and removal of main tube <NUM> during a surgical procedure. Main tube <NUM> would typically have a diameter between about <NUM> and about <NUM>, depending on the intended use of main tube <NUM> and the number of surgical instruments to be simultaneously guided. The overall length of main tube <NUM> can be selected according to the types of procedures being performed, but a typical length may be about <NUM> or more.

Main tube <NUM> also includes one or more instrument lumens <NUM>. Each instrument lumen <NUM> can be a flexible tube made of rubber, neoprene, pellethane, FEP, PTFE, Nylon, or other flexible material. Each instrument lumen <NUM> runs most of the length of main tube <NUM> and generally passes through openings in or lies on surfaces of the links or members that are part of the mechanical system for controlling the shape of main tube <NUM>. Each instrument lumen <NUM> can act to guide and house flexible surgical instruments that may be used during a surgical procedure. In particular, when needed, a flexible surgical instrument (not shown) can be inserted into an opening 112A at a proximal end of instrument lumen <NUM> and slid through the instrument lumen <NUM> so that a tool at the distal tip of the flexible surgical instrument emerges from an opening 112B at a distal end of the instrument lumen <NUM>. Instrument lumens <NUM> would typically have diameters sized for standardized surgical instruments, e.g., <NUM> or <NUM>, so that an instrument lumen <NUM> can handle many different types of instruments, for example, various shapes and types of forceps, scissors, scalpels, and cauterizing instruments. When an instrument in an instrument lumen <NUM> is not currently needed, the instrument can be removed from that instrument lumen <NUM> and replaced by another flexible instrument without the need for a complex and time consuming steering process. Sensors and cameras or other vision systems could similarly be inserted through instrument lumens <NUM>. Such easily replaceable instruments or other surgical systems may have their own backend mechanisms and/or interfaces that can be operated independently of backend mechanism <NUM>. Alternatively or additionally, main tube <NUM> may include surgical instruments, sensors, vision systems, fluid channels, or other surgically useful systems (not shown) that are not intended to be removed during a surgical procedure, and such systems may be mechanically or electrically operated through an interface provided by backend mechanism <NUM>.

Tendons <NUM> connect portions (e.g., mechanical links or fixed surgical systems) of main tube <NUM> to backend mechanism <NUM> and are shown in a cut-out portion of <FIG>. Tendons <NUM> can be, for example, stranded or woven cables, monofilament lines, or tubes made of metal or a synthetic material that provides sufficient strength and flexibility for operation of the systems connected to tendons <NUM>. Backend mechanism <NUM> generally operates as a transmission that pulls on tendons <NUM> when powered by a motor pack (not shown). Backend mechanism <NUM> includes an interface to which the motor pack can be mechanically coupled. In the illustrated embodiment, multiple toothed wheels <NUM> engage respective motors that rotate toothed wheels to control tensions in respective tendons <NUM> as described further below. For robotic operation, a control system (not shown) including a user interface operated by a surgeon and a computer executing software can control the motor pack. A sterile barrier may be provided between backend mechanism <NUM> and the main tube <NUM>, so that the motor pack and any other systems connected to backend mechanism <NUM> are not contaminated during a surgical procedure.

<FIG> schematically illustrates a portion <NUM> of an entry guide using an asymmetric spring systems <NUM> in a backend mechanism <NUM> to control the respective tensions in tendons 230A and 230B coupled to a mechanical link <NUM>. For ease of illustration, only two tendons 230A and 230B, generically referred to herein as tendons <NUM>, are shown in <FIG> and the illustrated tendons <NUM> are attached to the same link <NUM>. An actual entry guide may contain on the order of ten to in excess of one hundred links <NUM>, and each link <NUM> may have one or more tendons <NUM> that terminate at that link <NUM>. In general, the entry guide may be under-constrained, i.e., some links <NUM> may not be directly attached to or constrained by tendons <NUM>, but may be displaced by the stiffness of a sheath or skin (not shown) around links <NUM> or by a stiffening rod extending through links <NUM>. In an alternative embodiment, distal ends of tendons <NUM> may be attached to different portions of a flexible sheath to provide a continuum mechanism, which does not require links <NUM> or a hinged mechanism but is flexed by forces that tendons <NUM> apply to the sheath.

Tendons <NUM> may have proximal ends attached to respective asymmetric spring system <NUM> in backend mechanism <NUM> when compliance is desired in the attached link or mechanism of the entry guide. The entry guide may additionally include systems where compliance is not desired, and drive systems (not shown) in backend mechanism <NUM> may employ mechanisms, which are well known in the art, for non-compliant driving of tendons coupled the systems for which compliance is not desired.

Each spring system <NUM> in <FIG> includes a mechanical drive system <NUM>, a spring <NUM>, and a cam <NUM>. Drive system <NUM> converts rotational motion of driver motors <NUM> into linear motion, and spring <NUM> connects to drive system <NUM> so that the linear motion of drive system <NUM> moves a proximal end of the spring <NUM>. (Note that this conversion to linear motion is not a required element, the proximal end of each spring <NUM> may alternatively be attached to a cable that is wound around a pulley or capstan, which if necessary may be provided with a brake to prevent unwanted motion when the pulley or capstan is decoupled from a drive motor. ) Cam <NUM> has a first guide surface on which a cable <NUM> attached to the distal end of spring <NUM> attaches and rides and a second guide surface on which a portion of tendon <NUM> attaches and rides. These surfaces of cam <NUM> are generally at different distances from a rotation axis of cam <NUM>, so that the ratio of the tension in a tendon <NUM> to the spring force from spring <NUM> is equal to the ratio of the radial distance to the point where cable <NUM> separates from cam <NUM> to the radial distance to the point where tendon <NUM> separates from cam <NUM>. Each surface of cam <NUM> may be a spiral surface that extends for multiple revolutions in order to provide the desired range of movement of the tendon <NUM>.

The guide surfaces of cam <NUM> are further shaped to reduce or eliminate the dependency of the tension in attached tendon <NUM> on the position of the link <NUM> attached to that tendon <NUM>, and to the shape of the path of the tendon between the cam <NUM> and the link <NUM>. In particular, if cam <NUM> were replaced with a pulley having only circular guide surfaces, pulling tendon <NUM> would cause a proportional increase in the stretch of spring <NUM>, and assuming that spring <NUM> obeys Hooke's law, a linear increase in the tension in the tendon <NUM>. To reduce the dependence of the tension on external force applied to tendon <NUM> or link <NUM>, one or both of the surfaces of cam <NUM> is not circular, but provides a variable moment arm upon which either the tension in tendon <NUM> or the force from spring <NUM> acts as cam <NUM> rotates. For example, rotation of cam <NUM> that tends to stretch spring <NUM> can either decrease the moment arm at which spring <NUM> acts on cam <NUM> or increase the moment arm on which the tension in tendon <NUM> acts. As is known for constant force springs, the shape of cam <NUM> can be selected so that the tension in tendon <NUM> remains constant as movement of tendon <NUM> causes rotation of cam <NUM>, while at the same time, the spring force from spring <NUM> increases in accordance with Hooke's law. Spring system <NUM> can thus act as a constant force spring or alternatively just reduce the rate at which tension in tendon <NUM> changes as tendon <NUM> unwinds from cam <NUM>.

Embodiments of cams and suitable systems for producing constant force springs using linear springs are described in more detail in U. No. <CIT> and <CIT>.

Each mechanical system <NUM> controls the position of the proximal end of the corresponding spring <NUM> and thereby influences the amount of stretch in the corresponding spring <NUM> and the tension in the attached tendon <NUM>. In operation, if a mechanical system <NUM> in a spring system <NUM> pulls on the attached spring <NUM>, the spring <NUM> begins to stretch, and if the link <NUM> and tendon <NUM> attached to the spring system <NUM> are held fixed, the force that spring <NUM> applies to cam <NUM> increases and therefore the tension in the attached cable <NUM> increases. Accordingly, the tension in a tendon <NUM> depends linearly (in accordance with Hooke's law, the moment arms of cam <NUM>, and the spring constant of spring <NUM>) on movement of the proximal end of spring <NUM>, but each spring system <NUM> behaves asymmetrically, i.e., has a much weaker response or otherwise, acts with constant force, non-linear dependence, or smaller effective spring constant in response to external forces that move tendon <NUM>.

Each drive system <NUM> as mentioned above converts rotational motion, which may be provided by a drive motor <NUM> mechanically coupled to the drive system <NUM>, into linear motion of the proximal end of spring <NUM>. In an exemplary embodiment, drive system <NUM> is a ball screw, which includes a threaded shaft <NUM> that provides a spiral raceway for ball bearings held within a bore of a ball nut <NUM>. Ball nut <NUM> mechanically couples to a corresponding motor <NUM>, so that as motor <NUM> turns, shaft <NUM> moves into or out of the bore of gear <NUM>. A ball screw can provide minimal friction even when applying or withstanding significant force to or from spring <NUM>. However, other mechanical systems could alternatively be employed to stretch spring <NUM>. For example, a simple threaded device could operate in substantially the same manner as a ball screw but with greater friction. Alternatively, the proximal end of spring <NUM> could be attached to a cable that wraps around a capstan, so that a motor that drives the capstan could move the proximal end of spring <NUM>. A system of gears and levers could also be used to convert rotational motion to linear motion, or instead of converting rotational motion, a linear drive system such as a solenoid could be used to move the proximal end of spring <NUM>. The examples provided here simply illustrate a few of the mechanical systems suitable for drive system <NUM>, but clearly many other mechanical systems could be employed to move the proximal end of spring <NUM>.

An adjustable constant force spring or asymmetric spring system is not limited to use of linear or coils springs but can be constructed using other types of spring elements. <FIG> illustrates an example of a spring system 210B that uses a torsion spring 216B to produce a tension in a tendon <NUM> that is nearly independent of movement of tendon <NUM> but is adjustable using a drive motor <NUM>. In system 210B, torsion spring 216B has a distal end attached to a cam <NUM> so that rotation of cam <NUM> changes the torsion in torsion spring 216B. The torque caused by torsion spring 216B on cam <NUM> thus varies (e.g., linearly) with the angle of rotation of cam <NUM>. However, tendon <NUM> is wrapped on a surface of cam <NUM> that is shaped to change the moment arm on which tendon <NUM> acts so that a constant tension in tendon <NUM> causes a torque that changes in the same manner as torque from torsion spring 216B. As a result spring system 210B acts as a constant force spring. However, the spring force and tension in tendon <NUM> can be controlled by using motor <NUM> to rotate the proximal end of torsion spring 216B. In particular, motor <NUM> winding torsion spring 216B tighter (or looser) increases (or decreases) the tension in tendon <NUM>. Accordingly, each spring system <NUM> of <FIG> can be replaced with a spring system 216B, provided that the difference in the direction of the interface between motors <NUM> and the spring systems <NUM> and 216B is accommodated.

<FIG> shows an exemplary alternative asymmetric spring system 216C, which employs a constant force spring 216C. Constant-force spring 216C is a rolled ribbon of spring material that is relaxed when the ribbon is fully rolled up. As the ribbon unrolls, the portion of the ribbon near the roll produces the spring force. This spring force remains nearly constant as the ribbon unrolls because the portion of the ribbon that produces the spring force, i.e., the portion near the roll, has nearly the same shape as the spring unrolls. Tendon <NUM> when attached to a outer end of constant force spring 216C will experience a constant force from spring 216C as tendon <NUM> moves. However, an interface (e.g., a toothed wheel) <NUM> can be attached to the inner end of constant force spring 216C so that a motor (not shown) can engage interface <NUM> and change the constant force of spring 216C and the tension in tendon <NUM>. Accordingly, each spring system <NUM> of <FIG> can be replaced with a spring system 216C.

<FIG> illustrates a configuration in which two tendons 230A and 230B are coupled to the same link <NUM>. Link <NUM> can be mechanically constrained so that link <NUM> can only rotate about a single axis. Tendons 230A and 230B can then attach on the opposite side of the rotation axis, so that pulling on one tendon 230A or 230B causes one direction of rotation and pulling on the other tendon 230B or 230A cause rotation in the opposite direction. In this configuration, link <NUM> will be at rest when the forces, including external forces, frictional forces, and the tensions in tendons 230A and 230B, on link <NUM> are in equilibrium. A change in external forces applied to link <NUM>, for example, by movement of a patient during insertion of the entry guide of <FIG> or after the entry guide has been inserted, can cause link <NUM> to move. Further, this movement will cause little or no change in the tension in tendons 230A and 230B since the spring systems <NUM> are relatively insensitive to movement of tendons 230A and 230B. The entry guide does not respond to the external forces with rapidly increasing resistance, and spring back, which might otherwise occur with a constant length positioning system. (In contrast, most robotic mechanics and controls are set up to hold a constant position with variable force, not a constant force with variable position as in the entry guide of <FIG>. ) In the case where spring systems <NUM> act as constant force springs, the entry guide can be fully compliant without spring back even in the limit where friction is negligible. More generally, spring back can be avoided when increases in the tension in tendons <NUM> induced by the movement of the entry guide have less effect than does friction.

Link <NUM> in the entry guide of <FIG> can be moved by activating a motor <NUM> to turn a drive system <NUM> and change the tension in at least one of tendons 230A and 230B. The change in tension unbalances the equilibrium of forces causing link <NUM> to move until a new equilibrium is established. In general, this may involve operating one mechanical system <NUM> to stretch a corresponding spring <NUM> and increase tension in one tendon 230A or 230B. Optionally, the other mechanical system <NUM> may be operated to relax tension in the other tendon 230B or 230A. When link <NUM> rotates by the desired amount, tensions in the two tendons 230A and 230B can be adjusted as required to re-establish equilibrium (e.g., back to their original tension settings. ) In general, the positions of links <NUM> do not have a fixed relation to the setting of mechanical systems <NUM>. However, the position of each link <NUM> (or the shape of the entry guide as a whole) can be visually observed by an operator or sensed, for example, using a shape sensor such as described in U. No. <CIT>, and <CIT>. Movement of an entry guide employing the system of <FIG> may thus be robotically controlled or computer assisted using a control system <NUM> and a sensor <NUM> implementing a feedback loop that monitors the links <NUM> in the entry guide and controls drive motors <NUM>, for example, to steer the entry guide during an insertion process. Steering an entry guide to follow a natural lumen generally does not require rapid or rigid response, so that slow movement and use of forces just above the external resistance and internal frictional force may be desired to minimize movement that overshoots target position.

<FIG> illustrates one specific configuration of backend mechanism <NUM> and spring systems <NUM> relative to a main tube of an entry guide. However, many other configurations can alternatively be employed. In particular, in <FIG>, the axis or rotation of gears <NUM> are substantially parallel to the direction from which the main tube of the entry guide extends from backend mechanism <NUM>. If the spring systems 210B or 210C of <FIG> were used, the rotation axis of control motors <NUM> would be perpendicular to the direction of entry guide. <FIG> illustrates an alternative configuration using spring systems <NUM> but having a backend mechanism <NUM> using drive motors <NUM> with the rotation axes that are substantially perpendicular to the main tube. Again, spring systems 210B or 20C of <FIG> can be used in place of spring system <NUM> in the system of <FIG>.

<FIG> also illustrates a configuration in which three tendons 330A, 330B, and 330C have distal ends attached to the same link <NUM>. In this configuration, link <NUM> may have a pivot system that allows rotation of link <NUM> about two independent axes. The tensions in one or more of tendons 330A, 330B, and 330C can then be increased to tilt link <NUM> and the tensions can be brought back into balance (with each other, external forces, and friction) when link <NUM> reaches the desired orientation. The three tendons 330A, 330B, and 330C can thus be used to control two degrees of freedom of link <NUM>.

Claim 1:
A surgical device comprising:
a shaft (<NUM>) including a movable portion;
a first tendon (<NUM>, <NUM>) attached to the movable portion and extending through the shaft;
a first asymmetric spring system (<NUM>) having a spring, a first end of which is coupled to a cam, wherein the cam is coupled to the first tendon (<NUM>, <NUM>); and
a first mechanism (<NUM>, <NUM>, <NUM>) connected to control an amount of movement of a second end of the spring of the first asymmetric spring system (<NUM>);
wherein the cam (<NUM>) is configured to provide a variable moment arm such that a force applied by the first asymmetric spring system (<NUM>) to the first tendon (<NUM>, <NUM>) has greater dependence on an amount of movement of the second end of the spring of the first asymmetric spring system (<NUM>) than on an amount of movement of the first tendon (<NUM>, <NUM>).