Patent Description:
There are a multitude of endoscopic, arthroscopic or other surgical procedures that require the ability to pass suture through soft tissues as part of an effort to repair various damaged structures. Surgical instruments specifically designed to pass and/or retrieve suture through tissue have become increasingly popular among surgeons. Due to the size constraints of the surgical procedure, the pathway for the needle to pass through the instrument and tissue is typically non-linear. Because of this non-linear pathway, the needle used to pass or retrieve the suture must be flexible enough to bend, yet rigid enough to still pass through the tissue to be sutured. Some existing needles are unable to reliably meet these requirements.

The specific mechanism by which the suture can be passed or retrieved may be accomplished by the needle, the instrument, or a secondary suture capturing feature such as a wire loop snare. Suture mechanisms involving the instrument or secondary features will add complexity to the design of the instrument and may even add steps to the surgical procedure. Mechanisms that utilize the needle for suture retrieval typically do not actively grasp the suture without assistance from other features on the instrument.

In order to consistently pass and retrieve suture through tissue, a complex process is involved that combines the challenges, described above, of passing a needle over a non-linear pathway and reliably retrieving the suture, all while operating through a small cannula and working in the confines of a small anatomical space.

Aside from sutures, other types of implant devices may be required to be implanted with constraints similar to those described above. These implants may need to be implanted or removed over a non-linear pathway relative to the access ports. Accordingly, procedures involving such implants are similarly difficult with existing technology.

<CIT> relates to a surgical implement for applying sutures to tissue including a needle deployment mechanism and a catch mechanism. The needle deployment mechanism may comprise a linear needle path or a curved needle path. The catch mechanism may include a rotatable head. The needle catch does not comprise an intermediate portion having a selectively bendable portion that is variable between different configurations.

<CIT> relates to a surgical tool for endoscopic suture placement permits to place controlled and precise internal ligatures. The tool includes an outer sheath, a drive rod slidable mounted to said outer sheath for movement between a retracted position and an extended position, the drive rod including a deflecting portion having a first shape when the drive rod is in the retracted position and a second shape when the drive rod is in the extended position. When forced to the extended position, the deflecting portion forms a hook or J-shaped needle, the tip of which can be used to accurately position the suture. The tool does not comprise an intermediate portion having a selectively bendable portion with a cross sectional shape that is variable between different configurations.

The invention provides an apparatus for manipulating a suture in accordance with claim <NUM>. A number of embodiments of the invention are provided by claims <NUM> to <NUM>.

Various embodiments of the present invention and disclosure will be described in connection with <FIG>, as follows. These drawings are to be construed as nonlimiting examples; those of skill in the art will appreciate that a wide variety of modifications are possible.

The present invention provides an apparatus for manipulating a suture, the apparatus comprising:.

The presently preferred embodiments of the present invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present invention, as generally described and illustrated in the Figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the apparatus, as represented in <FIG>, is not intended to limit the scope of the invention.

Referring to <FIG>, a perspective view illustrates an implant manipulator <NUM> according to one example of the disclosure (not of the invention). The implant manipulator <NUM> of <FIG> may take the form of a pusher <NUM> designed to push a surgical implant (not shown) into a desired location within the tissues of a body. Other implant manipulator types will be disclosed on connection with other figures. The pusher <NUM> may have a longitudinal direction <NUM>, a lateral direction <NUM>, and a transverse direction <NUM>. The longitudinal direction <NUM> is parallel to the length, i.e., the long axis, of the pusher <NUM>. The directions <NUM>, <NUM> are orthogonal to it.

The pusher <NUM> may have a proximal end <NUM>, distal end <NUM>, and an intermediate portion <NUM> that extends between the proximal and distal ends <NUM>, <NUM>. Each end <NUM>, <NUM> of the pusher <NUM> may take on a blunt or flat profile. Alternatively, the proximal end <NUM> may have a gripping interface (not shown) such as a handle or the like, and/or the distal end <NUM> may have an implant interface (not shown) designed to retain an implant until it has reached its desired location. The pusher <NUM> may be used to place an implant within a body, reposition an implant within a body, and/or remove an implant from the body.

The cross-sectional shape of the pusher <NUM> may be generally V-shaped. As best seen at the distal end <NUM> in <FIG>, the cross-sectional shape may have a first arm <NUM>, a second arm <NUM>, and a spine <NUM>. The first and second arms <NUM>, <NUM> may be connected to the spine <NUM>, and as illustrated in <FIG>, they may be unitarily formed with the spine. The cross-sectional shape may be uniform along the entire length of the pusher <NUM>. The first and second arms <NUM>, <NUM> may extend from the spine <NUM> to define a perpendicular or near-perpendicular angle between the first and second arms <NUM>, <NUM>.

This cross-sectional shape, including the dimensions of its various parts, may result in a structure that has a high "flexural rigidity" relative to bending perpendicular to its long axis, as compared with other cross-sectional shapes such as rectangular or round profiles of similar material volume. Beneficially, the implant manipulator <NUM> has a relatively low profile. The "profile" of a medical instrument generally refers to the amount of tissue it must displace as it moves through the body. Tissue displacement leads to post-operative discomfort or pain and lengthens recovery time; hence, it is desirable for medical instruments to be "low profile. " The profile of an instrument is generally proportional to the area of the cross-sectional shape that must penetrate the tissue; in the case of a hollow cross-sectional shape such as a tube, the profile is generally proportional to the area of the shape plus the area of the interior space within the shape.

An implant manipulator like the pusher <NUM> may optionally be actuated by an actuator (not shown) that helps to control its motion. Such an actuator may take a variety of forms, including a suture passer, a meniscal repair device, a bone anchor placement instrument, or the like. The pusher <NUM> may be any instrument that moves a surgical implant to or from a desired location in a body, and the actuator may thus be any instrument that moves the implant manipulator to facilitate such motion. The actuator may be held by a user, a robotic surgical assembly, or a stationary framework, and may move the implant manipulator through manual control with or without intervening mechanical components. Alternatively, such an actuator may use electric motors or other motion sources to move the implant manipulator.

Referring to <FIG>, a perspective view illustrates an implant manipulator <NUM> according to an alternative example. The implant manipulator <NUM> may also be a pusher <NUM>. The pusher <NUM> may be flexible; i.e., designed to bend in a direction perpendicular to its long axis. Such bending may allow the pusher <NUM> to deflect, for example, subcutaneously, to reach a target area along a non-linear subcutaneous pathway. If desired, the pusher <NUM> may be made of a superelastic material, i.e., a material designed to undergo relatively large elastic deformation, and then return to its original shape. Further, the pusher <NUM> may be formed of a shape memory alloy or the like. According to one example, the pusher <NUM> (and other implant manipulators embodied herein) may be made of Nitinol.

Like the pusher <NUM>, the pusher <NUM> may have a proximal end <NUM>, a distal end <NUM>, and an intermediate portion <NUM>. At the distal end <NUM>, the pusher <NUM> has a cross-sectional shape with a first arm <NUM> and a second arm <NUM>, both of which are connected to a spine <NUM>. The pusher <NUM> may have the same cross-sectional shape at the proximal end <NUM>. However, the pusher <NUM> may have an intermediate portion <NUM> that is different from the intermediate portion <NUM> because the intermediate portion <NUM> may have a selectively bendable portion <NUM> at which the intermediate portion <NUM> is designed to bend. The selectively bendable portion <NUM> may be configured such that, in a first configuration, the selectively bendable portion <NUM> is substantially rigid, while in a second configuration, the selectively bendable portion <NUM> is able to bend more freely. "Selective" bending refers to deliberate, controllable bending, as opposed to bending that simply occurs as an unintended consequence of the use of an instrument.

This configuration change may occur in many different ways. Some materials are known to change elasticity when raised or lowered beyond certain transition temperatures. Alternatively, stiffening members (not shown) may be inserted into engagement with a needle along the needle axis to provide stiffening where, and when, it is desired. However, in the embodiment of <FIG>, selective bending is carried out by changing the cross-sectional shape of the selectively bendable portion <NUM>. More precisely, an object with a given cross-sectional shape and material composition will have a given "flexural rigidity," or resistance to bending. Generally, positioning material further from the geometric center of a cross-sectional shape will increase its flexural rigidity, at least as applied to bending parallel to the direction in which it is displaced from the geometric center. Thus, a tube made of a given material will tend to resist bending more effectively in all directions perpendicular to the tube axis than a cylinder made from the same material, with the same length.

The pusher <NUM> uses this principle to obtain additional stiffness when desired, and also to exhibit additional flexure when desired. In surgical applications, this is useful in a wide variety of contexts because it is very common to access a desired location within a body (such as a human body) along a nonlinear pathway, for example, to get around intervening bones or sensitive tissues, or to provide a desired angle of approach to the desired location. The nonlinear pathway may require that instruments bend to reach the desired location. However, it may be desirable for the instruments to retain significant stiffness to enable them to perform their intended functions at the desired location.

One example of an instrument that may need to move along a non-linear pathway is a needle for a suture passer. Such needles commonly are used to puncture tissue and either push or pull suture through the puncture along a direction nonparallel to the axis of the instrument. Unfortunately, prior art suture passers tend to exhibit a variety of problems related to the stiffness of the needle. A needle with the flexibility required to navigate the nonlinear pathway may not have sufficient rigidity to puncture the tissue without skiving against the tissue or otherwise deflecting from its intended approach vector.

The pusher <NUM> remedies these shortcomings through variation of the cross-sectional shape of the selectively bendable portion <NUM>. The selectively bendable portion <NUM> has a cross-sectional shape designed to permit selective flexure of the selectively bendable portion <NUM>. More precisely, the pusher <NUM> may have a slot <NUM> that interrupts the spine <NUM> along a given length of the intermediate portion <NUM> such that the spine <NUM> exists proximate the proximal and distal ends <NUM>, <NUM>, but the slot <NUM> is instead present in the selectively bendable portion <NUM>. The slot <NUM> may be cut or otherwise removed from a full-length spine like the spine <NUM> of <FIG>, or the pusher <NUM> may be formed with the spine <NUM> and the slot <NUM> in place.

The slot <NUM> permits the selectively bendable portion <NUM> to be re-configured during use by changing its cross-sectional shape to control its flexural rigidity, particularly as applied to bending along the lateral direction <NUM> and the transverse direction <NUM>. The selectively bendable portion <NUM> may have one flexural rigidity that applies to bending in the lateral direction <NUM>, and a different flexural rigidity that applies to bending in the transverse direction <NUM>.

The cross-sectional shape of the pusher <NUM> of <FIG> may be designed to restrict flexure of the pusher <NUM>. The slot <NUM> may effectively remove the spine <NUM> from the cross-sectional shape of the selectively bendable portion <NUM>, thereby allowing the arms <NUM>, <NUM> to bend, rotate, or deform in a manner that resembles the flexure that would be obtained if they were individual thin, flat, rectangular sections of material. Thus, the selectively bendable portion <NUM> may provide the flexibility to allow the pusher <NUM> to bend as shown in the examples in <FIG>. This concept will be shown and described in connection with <FIG>.

Referring to <FIG>, a section view perpendicular to the longitudinal direction <NUM> illustrates the cross-sectional shape of the selectively bendable portion <NUM> as configured in <FIG>. The selectively bendable portion <NUM> is configured to resist bending in the lateral and transverse directions <NUM>, <NUM>. The arms <NUM>, <NUM> are positioned at an angle <NUM> relative to each other; this angle <NUM> may be near <NUM>°. In alternative embodiments, in the rest (i.e., substantially undeflected) configuration, the arms <NUM>, <NUM> may be angled relative to each other at other angles, such as <NUM>° or <NUM>°, or angles in between, as will be shown and described subsequently.

As mentioned previously, the flexural rigidity of a shape is generally proportional to the distance of the material from the center of a shape. Thus, a long, flat cross-sectional shape would tend to allow easy bending perpendicular to the length of the cross-sectional shape, but resist bending parallel to the length of the cross-sectional shape. Each of the arms <NUM>, <NUM> provides a relatively long, flat cross-sectional shape, but since they are orthogonal to each other, the cross-sectional shape of <FIG> is not generally parallel to any direction. Thus, the flexural rigidity is relatively high for any bending direction perpendicular to the longitudinal direction <NUM> (i.e., the lateral direction <NUM>, the transverse direction <NUM>, or any direction that is a vector with lateral and longitudinal components).

Referring to <FIG>, a section view perpendicular to the longitudinal direction <NUM> illustrates the cross-sectional shape of the selectively bendable portion <NUM> with the selectively bendable portion <NUM> configured to resist bending in the lateral direction <NUM>, but permit bending relatively easily in the transverse direction <NUM>. The arms <NUM>, <NUM> are generally coplanar to each other. Accordingly, they are oriented at an angle <NUM> relative to each other of approximately <NUM>°. As shown, the angle <NUM> need not be exactly <NUM>° to facilitate bending in the transverse direction <NUM>. The angle <NUM> may, for example, be <NUM>°, <NUM>°, <NUM>°, <NUM>°, or <NUM>°. Depending on the nature of the force that moves the cross-sectional shape into the configuration shown in <FIG>, the angle <NUM> may even be larger than <NUM>°.

Referring to <FIG>, a section view perpendicular to the longitudinal direction <NUM> illustrates the cross-sectional shape of the selectively bendable portion <NUM> with the selectively bendable portion <NUM> configured to resist bending in the transverse direction <NUM>, but permit bending relatively easily in the lateral direction <NUM>. The arms <NUM>, <NUM> are generally non-coplanar to each other, but they are generally parallel to each other. Accordingly, they are oriented at an angle <NUM> relative to each other of approximately <NUM>°. As shown, the angle <NUM> need not be exactly <NUM>° to facilitate bending in the lateral direction <NUM>. The angle <NUM> may, for example, be <NUM>°, <NUM>°, <NUM>°, <NUM>°, or <NUM>°.

As a variation of the pusher <NUM> shown in <FIG>, the slot <NUM> may fully extend through to the distal end <NUM> or the proximal end <NUM> of the pusher <NUM>. At least one end <NUM> or <NUM> of the pusher <NUM> may advantageously maintain a length of the spine <NUM> so that the pusher <NUM> has rigidity at one end <NUM> or <NUM>. Rigidity at the proximal end <NUM> may be beneficial if the pusher <NUM> is being pushed proximal to distal by an instrument, while rigidity at the distal end <NUM> may be beneficial if the pusher <NUM> is being pushed against an implant or other device that needs to be advanced.

As another alternative, a slot may be shaped differently from the slot <NUM> shown in <FIG>. In alternative embodiments (not shown), such a slot may follow a curved or jagged pathway. Multiple slots may be used, and may be parallel or co-linear and broken by intervening lengths of a spine. As yet another alternative, the feature that facilitates bending need not be a slot, but may simply be a notch extending along the length of the intermediate portion of the implant manipulator (not shown). Such a notch may act a as a "living hinge" or "flexural hinge" by providing enhanced flexure without extending the fully through the material of the implant manipulator. As another alternative, an implant manipulator (not shown) may have a actual hinge, i.e., an interface between opposing sides that permits relative rotation between the two sides, thereby allowing the sides to collapse together and/or spread apart. As yet another alternative, an implant manipulator (not shown) may have a strip of a secondary material with lower flexural rigidity than the material of which the remainder of the implant manipulator is formed. All such alternatives are contemplated within the scope of the disclosure and may provide a cross-sectional change that restricts or facilitates bending of a selectively bendable portion, as desired.

Referring to <FIG>, the pusher <NUM> in <FIG>, may be modified as shown in <FIG> to take on the configuration of an implant manipulator <NUM> in the form of a needle <NUM>. Like the pusher <NUM>, the needle <NUM> may be generally rigid, and may have a proximal end <NUM>, a distal end <NUM>, and an intermediate portion <NUM>. The needle <NUM> may have the same V-shaped cross-sectional shape as the pusher <NUM>. Thus, the needle <NUM> may have a cross-sectional shape with a first arm <NUM>, a second arm <NUM>, and a spine <NUM>. The distal end <NUM> may be designed to penetrate tissue.

More specifically, the distal end <NUM> may have a sharpened tip such that it can be easily passed through tissue with minimal resistance to reduce any trauma to the body. As shown in <FIG>, the distal end <NUM> may have a first member <NUM> and a second member <NUM>, each of which has a sharpened tip <NUM>. The distal end <NUM> may also have an implant interface <NUM> designed to move an implant within the body in a desired manner. An "implant interface" includes any feature that abuts an implant (i.e., contacts the implant) in order to guide the implant in some manner. Thus, an implant interface may retain in implant, or it may simply push or otherwise drive it to the desired location. The desired location may be an implantation location within the body, or in the case of an implant to be removed, a location outside the body.

In the embodiment of <FIG>, the implant interface <NUM> may take the form of a suture capture feature <NUM>. A suture capture feature includes any feature that retains a length of suture to enable the length of suture to be moved. Thus, in this configuration, the needle <NUM> may be used to penetrate through a section of tissue, capture a section of suture material in the suture capture feature <NUM>, and then retrieve the suture material back through the tissue via withdrawal of the needle <NUM>. This can be beneficial when it is necessary to pass suture through tissue in a controlled manner without multiple instruments or features required for passing and retrieving the suture. The operation of the suture capture feature <NUM> will be shown and described in greater detail in connection with <FIG>.

Referring to <FIG>, the needle <NUM> of <FIG>, may be further modified to provide an implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> takes the form of a needle <NUM> with features that are generally similar to those of the needle <NUM>. However, the needle <NUM> has an intermediate portion <NUM> that is different from the intermediate portion <NUM> because the intermediate portion <NUM> has a selectively bendable portion <NUM> at which the intermediate portion <NUM> is designed to bend. The selectively bendable portion <NUM> may be configured such that, in a first configuration, the selectively bendable portion <NUM> substantially rigid, while in a second configuration, the selectively bendable portion <NUM> is able to bend more freely. More precisely, the spine <NUM> of the needle <NUM> may be interrupted by a slot <NUM> that generally traverses the intermediate portion <NUM> in a manner similar to that of the slot <NUM> of <FIG>. The slot <NUM> may enable the cross-sectional shape of the selectively bendable portion <NUM> to vary as in <FIG> to selectively facilitate bending parallel to the lateral direction <NUM> and/or the transverse direction <NUM>.

As with the pusher <NUM> of <FIG>, the needle <NUM> may be configured in a wide variety of ways. Such variations include variations of the slot <NUM> and other features used in place of the slot to provide cross-sectional change. Implant manipulators for being used in embodiments of the invention have a cross-sectional shape, perpendicular to the length of the implant manipulator that extends along a nonlinear pathway. A shape that extends along a pathway has a relatively consistent width perpendicular to a linear or nonlinear form embedded within the shape such that the form defines a pathway. The pathway extends through the center of the shape to bisect the width at each point along its length. A shape that extends along a pathway need not have a precisely constant width perpendicular to the pathway; rather, some variation is to be expected, particularly at the end points and any tight turns in the pathway.

In one example, a cross-sectional shape may have a width that never exceeds <NUM>% of its average width perpendicular to the pathway. According to another example, a cross-sectional shape may have a width that never exceeds <NUM>% of its average width perpendicular to the pathway. According to yet another example, a cross-sectional shape may have a width that never exceeds <NUM>% of its average width perpendicular to the pathway.

"Nonlinear" refers to a shape, at least part of which is not a straight line. Thus, a nonlinear shape may have a straight portion and a portion with a curve, vertex, or other departure from the straight line. These concepts will be shown and described in connection with <FIG>.

Referring to <FIG>, end views illustrate some of the cross-sectional shapes that may be used for an implant manipulator. More precisely, <FIG> illustrates an implant manipulator <NUM> having a V-shaped cross-sectional shape similar to the implant manipulators of <FIG>. The implant manipulator <NUM> may have a first arm <NUM> and a second arm <NUM>. The first arm <NUM> and the second arm <NUM> may be connected together via a spine <NUM>. The result may be a V-shape, which is upside-down in <FIG>.

A "V-shape" includes any shape with only two arms that join to define a vertex (or region with a small radius of curvature defining a near-vertex), leaving an open space, such as the space <NUM>, between the arms with unrestricted access to the space from outside the cross-sectional shape. Thus, if the first arm <NUM> and second arm <NUM> were modified such that they curve or angle toward each other on the opposite side of the space <NUM> from the spine <NUM>, the resulting cross-sectional shape (not shown) would not be a V-shape, but may instead be a C-shape (if the arms do not connect together) or an O-shape (if the arms do connect together). The arms of a V-shaped cross-sectional shape may be straight or curved. Additionally, the angle at the vertex need not be a right angle, as shown in <FIG>, but may be any of a wide variety of angles that will be shown and described in connection with <FIG>.

More particularly, the cross-sectional shape of the selectively bendable portion <NUM> may extend along a nonlinear pathway <NUM>. As shown, the nonlinear pathway <NUM> extends from the outermost tip of the first arm <NUM> to the outermost tip of the second arm <NUM>. The nonlinear pathway <NUM> defines a pathway within the definition provided above because the cross-sectional shape of the selectively bendable portion <NUM> has a relatively consistent width perpendicular to the nonlinear pathway <NUM>.

The nonlinear pathway <NUM> has a width <NUM> within the main portion of the first arm <NUM> and the second arm <NUM>. The nonlinear pathway <NUM> also has a width <NUM> across the spine <NUM>. Additionally, the nonlinear pathway <NUM> has a width <NUM> toward the outermost ends of the first arm <NUM> and the second arm <NUM>. The width <NUM> may be larger than the width <NUM>, and the width <NUM> may be larger than the width <NUM>, which tapers to zero at the ends of the nonlinear pathway <NUM>. However, the width of the cross-sectional shape is still relatively consistent along the length of the nonlinear pathway <NUM> despite these differences. In other embodiments (not shown), one or more of the first arm <NUM>, the second arm <NUM>, and the spine <NUM> may have a taper, a bump, recess, or other irregularity; such irregularities may change the shape of the nonlinear pathway <NUM>, but unless they are extreme, they do not keep the cross-sectional shape from being one that follows a pathway.

The nonlinear pathway <NUM> has linear segments within the first arm <NUM> and the second arm <NUM>, but has a small radius of curvature (e.g., a near-vertex as described above) through the spine <NUM>. Thus, the nonlinear pathway <NUM> is nonlinear and is also V-shaped within the definition provided above. In alternative embodiments, a nonlinear pathway like the nonlinear pathway <NUM> may be broken by one or more features such as the slot <NUM> of <FIG>. A "break" in a pathway may be defined as a location at which the material at the pathway is interrupted, but the pathway is still readily discernible. For example, the cross-section shown in <FIG> still presents a readily discernible V-shaped nonlinear pathway, despite the presence of the break defined by the intersection of the slot <NUM> with the cross-sectional shape.

In operation, the implant manipulator <NUM> may function in the manner illustrated in <FIG>. The V-shape may bend at or near the spine <NUM> to bring the first arm <NUM> and the second arm <NUM> close to a coplanar condition as in <FIG>, or may bend the other way to bring the first arm <NUM> and the second arm <NUM> close to a parallel condition as in <FIG>. Thus, the V-shape may be altered to facilitate or restrict bending as desired.

Referring to <FIG>, an end view illustrates an alternative implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may have an arcuate or U-shaped cross-sectional shape. More precisely, the implant manipulator <NUM> may have a first arm <NUM> and a second arm <NUM> that are connected together via a spine <NUM>. The first arm <NUM> and the second arm <NUM> are both curved, and share the same radius of curvature <NUM>. The spine <NUM> does not form a vertex like the spine <NUM> of <FIG>, but rather represents a continuous transition between the first arm <NUM> and the second arm <NUM>. In <FIG>, the spine <NUM> preserves the radius of curvature of the first arm <NUM> and the second arm <NUM>, although this need not be the case with other U-shaped cross-sectional shapes.

Generally, a "U-shape" includes any shape with only two arms that join at a radius to define a round in place of the vertex of a V-shape, leaving an open space, such as the space <NUM>, between the arms with unrestricted access to the space from outside the cross-sectional shape. A U-shape may have arms that are straight or curved.

The cross-sectional shape of the selectively bendable portion <NUM> extends along a nonlinear pathway <NUM>. As shown, the nonlinear pathway <NUM> extends from the outermost tip of the first arm <NUM> to the outermost tip of the second arm <NUM>. The nonlinear pathway <NUM> defines a pathway within the definition provided above because the cross-sectional shape of the selectively bendable portion <NUM> has a relatively consistent width perpendicular to the nonlinear pathway <NUM>.

The nonlinear pathway <NUM> has a width <NUM> within the main portion of the first arm <NUM>, the second arm <NUM>, and the spine <NUM>. Additionally, the nonlinear pathway <NUM> has a width <NUM> toward the outermost ends of the first arm <NUM> and the second arm <NUM>. The width <NUM> may be larger than the width <NUM>, which tapers to zero at the ends of the nonlinear pathway <NUM>. However, the width of the cross-sectional shape is still relatively consistent along the length of the nonlinear pathway <NUM> despite these differences. In other embodiments (not shown), one or more of the first arm <NUM>, the second arm <NUM>, and the spine <NUM> may have a taper, a bump, recess, or other irregularity; such irregularities may change the shape of the nonlinear pathway <NUM>, but unless they are extreme, they do not keep the cross-sectional shape from being one that follows a pathway.

The nonlinear pathway <NUM> has no linear segments, but rather has a constant radius of curvature <NUM> through the first arm <NUM>, the second arm <NUM>, and the spine <NUM>. The first arm <NUM> and the second arm <NUM> join at the spine, <NUM>, and all of them share the same radius of curvature <NUM>. Since the spine <NUM> has a relatively large radius, the nonlinear pathway <NUM> is nonlinear and is also U-shaped within the definition provided above.

In operation, the implant manipulator <NUM> may function in a manner somewhat similar to that of <FIG>. More precisely, as shown in <FIG>, the implant manipulator <NUM> may generally resist bending along the lateral direction <NUM> or the transverse direction <NUM> because the cross-sectional shape in <FIG> has significant mass displaced from its geometric center along both directions. However, if the first arm <NUM> and the second arm <NUM> were to be splayed outward so that the radius of curvature <NUM> is effectively increased (analogous to <FIG>), the flexural rigidity of the implant manipulator <NUM> with reference to bending along the transverse direction <NUM> would be effectively decreased, while the flexural rigidity for bending along the lateral direction <NUM> would be increased. If desired, the cross-sectional shape of the implant manipulator <NUM> may even flex sufficiently that the nonlinear pathway <NUM> extends in a substantially straight line.

If the first arm <NUM> and the second arm <NUM> were to be urged together so that the radius of curvature <NUM> is effectively decreased (analogous to <FIG>), the flexural rigidity of the implant manipulator <NUM> with reference to bending along the lateral direction <NUM> would be effectively decreased, while flexural rigidity for bending along the transverse direction <NUM> would be decreased. If desired, the cross-sectional shape of the implant manipulator <NUM> may flex such that the radius of curvature <NUM> becomes variable along the length of the nonlinear pathway <NUM>. For example, the spine <NUM> may experience greater deflection than the second arm <NUM> and the spine <NUM> so that, at the spine <NUM>, the radius of curvature is smaller than at the first arm <NUM> and the second arm <NUM>. If desired, the cross-sectional shape of the implant manipulator <NUM> may vary sufficiently that the ends of first arm <NUM> and the second arm <NUM> come into contact with each other.

In alternative embodiments (not shown), an implant manipulator may have a U-shaped cross-sectional shape like the implant manipulator <NUM> of <FIG> in combination with other features disclosed in connection with other embodiments herein. For example, such an implant manipulator may have a slot like the slot <NUM> of <FIG>, an implant interface <NUM> like that of <FIG>, or the like. Alternatively, such an implant manipulator may have other features that facilitate change of its cross-sectional shape. For example, such an implant manipulator may have a differently-shaped slot, a groove, or other recess that does not extend fully through its spine, a region of more flexible material (for example, at the spine), or any other change disclosed elsewhere in this specification.

Referring to <FIG>, an end view illustrates another implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may be similar to the implant manipulator <NUM> of <FIG>, except that the corners and edges of the implant manipulator <NUM> are squared rather than rounded. Such squared edges may facilitate tissue puncturing and/or penetration. The use of squared or rounded edges may depend on the desired tissue penetration characteristics of the implant manipulator.

Referring to <FIG>, an end view illustrates another implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may be similar to that of <FIG>, but with shorter arms. The arms of an implant manipulator may be shortened or lengthened to obtain the desired bending and/or tissue penetration characteristics.

Referring to <FIG>, an end view illustrates another implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may be similar to that of <FIG>, but with arms of unequal length. Such a configuration may further provide a desired set of bending and/or tissue penetration characteristics.

Referring to <FIG>, an end view illustrates an implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may have an elongated spine between shorter arms. The arms and/or spine may flex to selectively restrict or facilitate bending. Such a configuration may further provide a desired set of bending and/or tissue penetration characteristics.

Referring to <FIG>, an end view illustrates another implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may have a spine with a relatively large radius of curvature, with arms that extend from the spine generally parallel to each other. Like the spine <NUM> of the implant manipulator <NUM> of <FIG>, the spine of the implant manipulator <NUM> may flex via variation of its center of curvature. The result of such flexure may be alteration of the relative orientations of the arms, thereby selectively facilitating or restricting bending.

Referring to <FIG>, an end view illustrates another implant manipulator <NUM> for being used in an embodiment of the invention. The implant manipulator <NUM> may be similar to the implant manipulator <NUM> of <FIG>, but with a larger radius of curvature. Such a configuration may further provide a desired set of bending and/or tissue penetration characteristics.

The V-shaped nonlinear pathway <NUM> and the U-shaped nonlinear pathway <NUM> of <FIG>, and the nonlinear pathways of <FIG> are merely exemplary; a wide variety of alternative cross-sectional shapes may be used within the scope of the present invention. For example, in alternative embodiments (not shown), a selectively flexible portion of an implant manipulator may have a C-shaped, D-shaped, H-shaped, I-shaped, J-shaped, K-shaped, L-shaped, M-shaped, N-shaped, O-shaped, S-shaped, T-shaped, W-shaped, X-shaped, Y-shaped, or Z-shaped cross-section extending along the corresponding nonlinear pathway. According to the invention such cross-sectional shapes are variable between different configurations to provide a selectively bendable portion, the flexural rigidity of which can be controlled through variation of the cross-sectional shape.

Referring to <FIG>, end views illustrate how the angulation of the V-shaped cross-section can vary to alter the stiffness and profile of the device. More specifically, <FIG> illustrates an implant manipulator <NUM> according to one alternative for being used in an embodiment <FIG> illustrates the implant manipulator <NUM> of <FIG>, and <FIG> illustrates an implant manipulator <NUM> according to another alternative for being used in an embodiment of the invention.

Referring to <FIG>, an end view illustrates the implant manipulator <NUM>. The implant manipulator <NUM> may have a first arm <NUM> and a second arm <NUM> that are joined at a spine <NUM> to define a V-shaped cross-sectional shape, as described in connection with <FIG>. The implant manipulator <NUM> may have a selectively bendable portion <NUM> having the cross-sectional shape shown in <FIG>. In its generally unaltered (i.e., undeflected) state, the cross-sectional shape may have an angle <NUM> between the first arm <NUM> and the second arm <NUM>. As shown in <FIG>, the angle <NUM> may be an obtuse angle, i.e., an angle greater than <NUM>°. The angle <NUM> may fall within the range of <NUM>° to <NUM>°. More particularly, the angle <NUM> may fall within the range of <NUM>° to <NUM>°. Yet more particularly, the angle <NUM> may fall within the range of <NUM>° to <NUM>°. Still more particularly, the angle <NUM> may be <NUM>°.

Referring to <FIG>, an end view illustrates the implant manipulator <NUM>. The various features of the implant manipulator <NUM> are described in connection with <FIG>. As shown in <FIG>, the cross-sectional shape of the implant manipulator <NUM> may have an angle <NUM> between the first arm <NUM> and the second arm <NUM>, in its unaltered state. The angle <NUM> may be a right angle, i.e., a <NUM>° angle.

Referring to <FIG>, an end view illustrates the implant manipulator <NUM>. The implant manipulator <NUM> may have a first arm <NUM> and a second arm <NUM> that are joined at a spine <NUM> to define a V-shaped cross-sectional shape, as described in connection with <FIG>. The implant manipulator <NUM> may have a selectively bendable portion <NUM> having the cross-sectional shape shown in <FIG>. In its unaltered state, the cross-sectional shape may have an angle <NUM> between the first arm <NUM> and the second arm <NUM>. As shown in <FIG>, the angle <NUM> may be an acute angle, i.e., an angle less than <NUM>°. The angle <NUM> may fall within the range of <NUM>° to <NUM>°. More particularly, the angle <NUM> may fall within the range of <NUM>° to <NUM>°. Yet more particularly, the angle <NUM> may fall within the range of <NUM>° to <NUM>°. Still more particularly, the angle <NUM> may be <NUM>°.

The implant manipulator <NUM> generally has high flexural rigidity for bending along the lateral direction <NUM> or along the transverse direction <NUM>. The larger angle <NUM> of the implant manipulator <NUM> provides greater flexural rigidity for bending along the lateral direction <NUM>, but less flexural rigidity for bending along the transverse direction <NUM>. Conversely, the smaller angle <NUM> of the implant manipulator <NUM> provides greater flexural rigidity for bending along the transverse direction <NUM>, but less flexural rigidity for bending along the lateral direction <NUM>. Thus, the angulation of arms in a V-shaped cross-section may be tailored meet the desired bending characteristics of the instrument. Additionally, the length of the arms may be altered to further alter the stiffness and profile of the instrument.

Referring to <FIG>, a top elevation view illustrates the distal end <NUM> of the implant manipulator <NUM> of <FIG> or the needle <NUM> of <FIG> in greater detail. The implant interface <NUM> may take the form of a suture capture feature <NUM> designed to retain suture <NUM> in response to relative motion by which the suture comes toward the distal end <NUM>, as indicated by the arrow <NUM>.

As in <FIG> and 4A-4D, the suture capture feature <NUM> may have a first member <NUM> and a second member <NUM>, each of which has a tip <NUM>. Each of the tips <NUM> may be sharp to enable the first member <NUM> and the second member <NUM> to puncture tissue with relative ease and little trauma. Thus, each of the tips <NUM> may be acutely-angled. The suture capture feature <NUM> also has a capture hole <NUM> shaped and sized to receive the suture, and a channel <NUM> that extends between the first member <NUM> and the second member <NUM> to provide access to the capture hole <NUM>.

As shown, the capture hole <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate section <NUM> between the proximal section <NUM> and the distal section <NUM>. The distal section <NUM> may have a generally semicircular shape, broken by the channel <NUM> that widens toward the intermediate section <NUM>. The diameter of the semicircular shape may be sized larger than the uncompressed diameter of the suture the suture capture feature <NUM> is designed to retain. According to one embodiment, the suture capture feature <NUM> is made to capture a #<NUM> suture <NUM> with an uncompressed outer diameter of about <NUM>. The semicircular shape of the distal section <NUM> may be sized to receive the suture <NUM> without compression so that the suture <NUM>, when residing in the distal section <NUM>, may be drawn through the distal section <NUM> along the transverse direction <NUM>. According to one example, the diameter of the semicircular shape of the distal section <NUM> is about <NUM>. In alternative embodiments, this diameter ranges from <NUM> to <NUM>, or more particularly from <NUM> to <NUM>, or yet more particularly from <NUM> to <NUM>.

The proximal section <NUM> may also have a generally semicircular shape that widens toward the intermediate section <NUM>. The diameter of the semicircular shape of the proximal section <NUM> may be smaller than the uncompressed diameter of the suture <NUM> so that the suture <NUM> can be wedged within the proximal section <NUM> by urging the suture <NUM> against the proximal section <NUM> in the direction shown by the arrow <NUM>. Thus, the suture <NUM> may be firmly retained to restrict further relative motion between the suture <NUM> and the distal end <NUM> in any direction, and particularly, in the transverse direction <NUM>. The extended length of the capture hole <NUM> may also increase the ability of the first arm <NUM> and the second arm <NUM> to flex outward relative to each other to widen the channel <NUM>, thereby permitting passage of the suture <NUM> through the channel <NUM>. According to one example, the diameter of the semicircular shape of the proximal section <NUM> is about <NUM>. In alternative embodiments, this diameter ranges from <NUM> to <NUM>, or more particularly from <NUM> to <NUM>, or yet more particularly from <NUM> to <NUM>.

The intermediate section <NUM> may have straight walls that define a taper angle <NUM> leading from the distal section <NUM> to the proximal section <NUM>. The taper angle <NUM> may control how much force is needed to capture the suture <NUM> in the proximal section <NUM>, and also controls the overall length of the capture hole <NUM>. A more gentle taper angle <NUM> may enable capture with less force. According to one embodiment, the taper angle <NUM> may be about <NUM>°. According to alternative embodiments, the taper angle <NUM> ranges from <NUM>° to <NUM>°, or more particularly, from <NUM>° to <NUM>°, or yet more particularly, from <NUM>° to <NUM>°.

In addition to controlling suture retention characteristics, the shape of the capture hole <NUM> may also control deflection of the first member <NUM> and the second member <NUM>. The first member <NUM> and the second member <NUM> may deflect apart to enable the suture <NUM> to pass from a location distal to the distal end <NUM> into the capture hole <NUM>. In the alternative, the distal end <NUM> may be rigid enough that there is no significant outboard flexure of the first member <NUM> and the second member <NUM>. Thus, the suture <NUM> may simply deflect sufficiently to pass through the channel <NUM> without significant flexure of the suture capture feature <NUM>.

In alternative embodiments, a capture hole may take on a number of different shapes. For example, including round, oval, rectangular, square, triangular, or any combination of these or other similar shapes may be used. The shape of the suture capture hole may be adapted to the desired retention characteristics of the suture capture hole, the type of suture to be used, the surrounding material available, and other factors.

The channel <NUM> may have a proximal section <NUM>, a distal section <NUM>, and an intermediate section <NUM>. The suture <NUM> may enter through the distal section <NUM>, pass through the intermediate section <NUM>, and then pass through the proximal section <NUM> to enter the capture hole <NUM>. Thus, the distal section <NUM> may advantageously be large enough to receive the suture <NUM> without precise alignment of the suture <NUM> with the axis of the distal end <NUM>. This would allow for some variance or error in the trajectory that the distal end <NUM> takes towards the suture <NUM>, post, and/or other features present on an associated instrument that facilitate spreading of the first member and the second member <NUM>, or that help urge motion of the suture <NUM> through the channel <NUM>. The space between the tips <NUM> may advantageously not be so large as to adversely affect the ability of the needle to easily penetrate through tissue, or to cause unnecessary trauma to the tissue.

According to one example, the tips <NUM> of the first member <NUM> and the second member <NUM>, when in their natural or undeflected state, may be about <NUM> apart when used with a #<NUM> sized suture. This distance may be about twice the diameter of the suture used; this ratio may be used to properly dimension a distal end like the distal end <NUM> for a wide range of suture sizes. This distance may be the same as the width of the capture hole <NUM> in the lateral direction <NUM>. In alternative embodiments, this displacement ranges from <NUM> to <NUM>, or more particularly from <NUM> to <NUM>, or yet more particularly from <NUM> to <NUM>.

The distal section <NUM> may taper toward the intermediate section <NUM> with a taper angle <NUM> that is large enough to guide the suture <NUM> from a variety of possible locations between the tips <NUM> to the intermediate section <NUM>. According to one embodiment, the taper angle <NUM> may be about <NUM>°. According to alternative embodiments, the taper angle <NUM> ranges from <NUM>° to <NUM>°, or more particularly, from <NUM>° to <NUM>°, or yet more particularly, from <NUM>° to <NUM>°.

The intermediate section <NUM> may also have a taper angle <NUM> which may be smaller (i.e., shallower) than the taper angle <NUM>. The taper angle <NUM> may be selected such that, as the suture <NUM> passes through the intermediate section <NUM>, the suture <NUM> pushes the walls of the intermediate section <NUM> apart to induce flexure in the distal end <NUM> to spread the first member <NUM> and the second member <NUM> apart. However, the suture <NUM> may lack the rigidity to flex the first member <NUM> and the second member <NUM> apart. Thus, according to one embodiment of the invention, the distal end <NUM> may be flexed by the introduction of a post into the channel <NUM>. This will be shown in connection with <FIG>. The taper angle <NUM> additionally or alternatively may also be selected such that the suture <NUM> is compressed to the desired extent prior to entry into the proximal section <NUM>. In the alternative, as mentioned previously, the first member <NUM> and the second member <NUM> may be designed such that they do not flex apart. In such an embodiment, a post may not need to be used.

The taper angle <NUM> may control how much force is needed to get the suture <NUM> and/or the post to pass through the intermediate section <NUM> and into the proximal section <NUM>. A small or shallow taper angle <NUM> may facilitate entry of the suture <NUM> and/or post into the proximal section <NUM> but may require additional motion of the distal end <NUM> along the longitudinal direction <NUM> to position the suture <NUM> and/or post within the proximal section <NUM>. Conversely, a steeper or larger taper angle <NUM> may increase the force, but reduce the displacement, required to position the suture <NUM> and/or post within the proximal section <NUM>.

According to one example, the taper angle <NUM> may be about <NUM>°. According to alternative embodiments, the taper angle <NUM> ranges from <NUM>° to <NUM>°, or more particularly, from <NUM>° to <NUM>°, or yet more particularly, from <NUM>° to <NUM>°.

The proximal section <NUM> may have walls that are substantially parallel to each other. The walls may be spaced apart such that the suture <NUM> must compress to pass through the proximal section <NUM>, whether or not a post is used to cause flexure of the distal end <NUM>. The walls may further be spaced apart such that, even with the first member <NUM> and the second member <NUM> flexed apart, the proximal section <NUM> remains too small to permit the suture <NUM> to pass through without compression of the suture <NUM>. This may have the advantage of enabling the suture <NUM> to be captured against the corners defined by the intersection of the distal section <NUM> of the capture hole <NUM> with the proximal section <NUM> of the channel <NUM>. However, in alternative embodiments, when flexed apart, the walls of the proximal section may be sufficiently spaced apart to permit the suture <NUM> to pass relatively freely through the proximal section, i.e., without significant compression of the suture <NUM>. In other alternative embodiments, the walls of the proximal section may be sufficiently spaced apart to permit the suture <NUM> to pass relatively freely therethrough without flexure of the suture capture feature.

More specifically, once the suture <NUM> is positioned within the capture hole <NUM>, the distal end <NUM> may be drawn proximally such that the suture <NUM> is pinched between the corners and/or compressed against the corners defined by the intersection of the distal section <NUM> of the capture hole <NUM> with the proximal section <NUM> of the channel <NUM>. This pinching motion may restrict further motion of the suture <NUM> until it is pulled proximally toward the center of the capture hole <NUM>. In particular, motion of the suture <NUM> in the transverse direction <NUM> may be restricted or prevented by this pinching motion. Thus, the suture <NUM> can be drawn through a hole in tissue or in an implant within the body as the distal end <NUM> is drawn proximally.

According to one example, where the suture <NUM> has an uncompressed diameter of <NUM>, the walls of the proximal section <NUM> may be spaced apart <NUM>. The walls of the proximal section <NUM> may be spaced apart by a distance equal to the diameter of the semicircular shape of the proximal section <NUM> of the capture hole <NUM>. In alternative embodiments, the wall spacing ranges from <NUM> to <NUM>, or more particularly from <NUM> to <NUM>, or yet more particularly from <NUM> to <NUM>.

Various other dimensions of the exemplary embodiment of <FIG> will be provided, as follows. The longitudinal lengths of the proximal section <NUM>, the distal section <NUM>, and the intermediate section <NUM> of the capture hole <NUM> may be about <NUM>, about <NUM>, and about <NUM>, respectively. The longitudinal lengths of the proximal section <NUM>, the distal section <NUM>, and the intermediate section <NUM> of the channel <NUM> may be about <NUM>, about <NUM>, and about <NUM>, respectively. The distal end <NUM> may be <NUM> wide proximally of the first member <NUM> and the second member <NUM>. These dimensions may be particularly applicable to the capture of the #<NUM> suture referenced above; accordingly, all of the linear dimensions set forth herein may need to be increased or decreased if the suture to be captured is larger or smaller, respectively, than a #<NUM> suture.

In operation, the distal end <NUM> may first be aligned with the suture <NUM> and/or post, at least so that the majority of the suture <NUM> and/or post is positioned inboard of the tips <NUM> of the first member <NUM> and the second member <NUM>. The distal end <NUM> may then be advanced toward the suture <NUM> and/or post so that the suture <NUM> and/or post enters the distal section <NUM> of the channel <NUM>. The distal end <NUM> may be further advanced so that the suture <NUM> and/or post passes into the intermediate section <NUM>.

The distal end <NUM> may be further urged distally so that the suture <NUM> and/or post spreads the walls of the intermediate section <NUM> apart to cause the first member <NUM> and the second member <NUM> to move apart and/or compress the suture <NUM>. The distal end <NUM> may be further urged distally so that the suture <NUM> and/or post enters the proximal section <NUM> of the channel <NUM>. Further urging of the distal end <NUM> distally may cause the suture <NUM> and/or post to advance through the proximal section <NUM> of the channel <NUM>, thereby driving the first member <NUM> and the second member <NUM> further apart and/or further compress the suture <NUM>. Then, the suture <NUM> and/or post may enter the capture hole <NUM>.

With the suture <NUM> in the capture hole <NUM>, the distal end <NUM> may be urged proximally to pinch the suture <NUM> between the corners defined by the intersection of the distal section <NUM> of the capture hole <NUM> with the proximal section <NUM> of the channel <NUM>. The distal end <NUM> may be further urged proximally until the distal end <NUM> is outside the body, where the suture <NUM> may be shifted back toward the center of the capture hole <NUM> and then moved along the transverse direction <NUM> to exit the capture hole <NUM>.

Alternatively, with the suture <NUM> in the capture hole <NUM>, the distal end <NUM> may be urged distally to pinch the suture <NUM> between the tapering walls of the intermediate section <NUM> and/or between the opposing sides of the proximal section <NUM> of the capture hole <NUM>. The distal end <NUM> may then be urged proximally as set forth above, and the suture <NUM> may be moved toward the center of the capture hole <NUM> to permit the suture <NUM> to move transversely out of the capture hole <NUM>.

In the alternative to the foregoing capture method, suture capture may be carried out without significant flexure of the distal end <NUM>. This may be accomplished without the use of a post. In such an alternative method, the steps are similar to those set forth above, but without the associated flexure of the first member <NUM> and the second member <NUM>. In place of such flexure, the suture <NUM> may compress to move through the channel <NUM>. Alternatively, a pusher (not shown) can be used to push the suture <NUM> material through channel <NUM> and into the capture hole <NUM>. Lastly, two ends of the suture <NUM> may be grasped to secure the suture <NUM> as it is either pulled into the suture capture hole <NUM>, or the distal end <NUM> is advanced until the suture <NUM> resides in the capture hole <NUM>.

Referring to <FIG>, a top elevation view illustrates the distal end <NUM> of an implant manipulator (not shown) according to another alternative embodiment. The implant manipulator may have a proximal end <NUM> and an intermediate portion <NUM> like those of the needle <NUM> of <FIG> or the needle <NUM> of <FIG>. The distal end <NUM> may have an implant interface <NUM> that may take the form of a suture capture feature <NUM> designed to retain suture <NUM> in response to relative motion by which the suture comes toward the distal end <NUM>, as indicated by the arrow <NUM>. The distal end <NUM> may also have a first member <NUM> and a second member <NUM>, each of which has a tip <NUM> with an acute angle selected to facilitate puncturing of tissue.

The suture capture feature <NUM> is somewhat similar to the suture capture feature <NUM>. The suture capture feature <NUM> may have a capture hole <NUM> and a channel <NUM> extending between the first member <NUM> and the second member <NUM> to provide access to the capture hole <NUM> from distally of the distal end <NUM>. The suture capture feature <NUM> may generally function similarly to the suture capture feature <NUM> shown in <FIG>. Thus, in response to motion of the suture <NUM> and/or a post along the direction shown by the arrow <NUM>, the first member <NUM> and the second member <NUM> may spread apart and/or the suture <NUM> may be compressed as it travels through the channel <NUM>.

The capture hole <NUM> and the channel <NUM> are different from those of the suture capture feature <NUM> of <FIG>. More specifically, the capture hole <NUM> may simply be circular in shape, except where it joins the channel <NUM>. The capture hole <NUM> may be sized somewhat larger than the uncompressed diameter of the suture <NUM>. For a #<NUM> suture, the capture hole <NUM> may be <NUM> in diameter. The channel <NUM> may have a proximal section <NUM>, a distal section <NUM>, a distal intermediate section <NUM>, and a proximal intermediate section <NUM>. The proximal section <NUM>, the distal section <NUM>, and the proximal intermediate section <NUM> may be substantially the same as the proximal section <NUM>, the distal section <NUM>, and the intermediate section <NUM>, respectively, of the suture capture feature <NUM>.

The distal intermediate section <NUM> may be between the distal section <NUM> and the proximal intermediate section <NUM>. The distal intermediate section <NUM> may have substantially straight, parallel walls like those of the proximal section <NUM>, but with a larger width. The walls of the distal intermediate section <NUM> may be <NUM> apart.

The distal intermediate section <NUM> may serve to lengthen the channel <NUM>. This may serve to facilitate flexure of the first member <NUM> and the second member <NUM>, as a longer moment arm is acting on them during passage of the suture <NUM> and/or the post through the channel <NUM>. The distal intermediate section <NUM> may also divide the tactile response of the implant manipulator into more distinct events so that a surgeon can easily tell by the feel of the instrument where the suture <NUM> is. For example, the surgeon, if operating the implant manipulator manually, may feel some resistance as the suture <NUM> enters the distal intermediate section <NUM> from the distal section <NUM>. The surgeon may feel a distinct resistance again when the suture <NUM> passes from the distal intermediate section <NUM>, through which it passes relatively freely, to the proximal intermediate section <NUM>.

Referring to <FIG>, perspective views illustrate how the needle <NUM> of <FIG> may bend. As mentioned previously, the selectively bendable portion <NUM> may be reconfigurable to enable significant bending along the lateral direction <NUM> or the transverse direction <NUM>. In <FIG>, the needle <NUM> is shown bent in a downward direction, along the transverse direction <NUM>. The proximal end <NUM> and the distal end <NUM> may still have the original V-shaped cross-sectional shape; the presence of the spine <NUM> at the proximal end <NUM> and the distal end <NUM> may restrict the ability of the cross-sectional shape at the proximal end <NUM> and the distal end <NUM> to change. However, the slot <NUM> may allow the first arm <NUM> and the second arm <NUM> to rotate relative to each other about the longitudinal direction <NUM> so that the first arm <NUM> and the second arm <NUM> become substantially coplanar, as shown in <FIG>. This enables the selectively bendable portion <NUM> to bend along the transverse direction <NUM> so that the distal end <NUM> can bend upward or downward relative to the proximal end <NUM>.

<FIG> shows the selectively bendable portion <NUM> flexed to orient the distal end <NUM> downward relative to the proximal end <NUM>. Similarly, with the first arm <NUM> and the second arm <NUM> in the generally coplanar configuration, the selectively bendable portion <NUM> may flex to orient the distal end <NUM> upward relative to the proximal end <NUM>.

A transitional region <NUM> may exist between the proximal end <NUM> and the selectively bendable portion <NUM>, wherein the cross-sectional shape transitions between the V-shaped cross-sectional shape of the proximal end <NUM> to the generally coplanar cross-sectional shape of the selectively bendable portion <NUM>. The proximal end <NUM> may thus remain relatively rigid relative to bending along the lateral direction <NUM> and the transverse direction <NUM>. This may facilitate retention of the proximal end <NUM> in a user's hand (not shown), in an actuator (not shown), or in another instrument (not shown).

A transitional region <NUM> may similarly exist between the distal end <NUM> and the selectively bendable portion <NUM>, wherein the cross-sectional shape transitions between the V-shaped cross-sectional shape of the distal end <NUM> to the generally coplanar cross-sectional shape of the selectively bendable portion <NUM>. The distal end <NUM> may thus remain relatively rigid relative to bending along the lateral direction <NUM> and the transverse direction <NUM>. This may facilitate retention of an implant such as the suture <NUM> with the distal end <NUM>, and may also facilitate puncturing of tissue with the distal end <NUM>. If the distal end <NUM> were to be easily bendable in the lateral direction <NUM> or the transverse direction <NUM>, axial force pressing the tips <NUM> into tissue could lead the tips <NUM> to skive or otherwise deflect from the tissue to be penetrated as the distal end <NUM> buckles or bends. Thus, keeping the distal end <NUM> relatively rigid may provide distinct advantages for the invention.

<FIG> shows the selectively bendable portion <NUM> flexed to orient the distal end <NUM> to the right relative to the proximal end <NUM>. Similarly, with the first arm <NUM> and the second arm <NUM> in the generally parallel configuration like that of <FIG>, the selectively bendable portion <NUM> may flex to orient the distal end <NUM> to the left relative to the proximal end <NUM>.

A transitional region <NUM> may exist between the distal end <NUM> and the selectively bendable portion <NUM>, wherein the cross-sectional shape transitions between the V-shaped cross-sectional shape of the distal end <NUM> to the generally parallel cross-sectional shape of the selectively bendable portion <NUM>. The distal end <NUM> may thus remain relatively rigid relative to bending along the lateral direction <NUM> and the transverse direction <NUM>. As mentioned previously, the relative rigidity of the distal end <NUM> may facilitate implant retention and/or tissue penetration. A similar transitional region may exist between the proximal end <NUM> and the selectively bendable portion <NUM>.

Referring to <FIG>, there are a number of mechanisms by which a suture, such as the suture <NUM>, may be retained by an implant interface such as the suture capture feature <NUM> of <FIG>. As mentioned previously, one such mechanism is deflection of the distal end <NUM> that spreads the first member <NUM> and the second member <NUM> apart. Such deflection may be carried out by a post or pusher (not shown), or by the suture <NUM> itself. Different modes of flexure are possible, as will be shown and described in connection with <FIG>.

<FIG> provide a top elevation view and an end view, respectively, of the distal end <NUM> of <FIG>, in the undeflected state. The channel <NUM> thus has the shape shown in <FIG>, and the first member <NUM> and the second member <NUM> extend generally parallel to each other. The first member <NUM> and the second member <NUM> may be generally orthogonal to each other, as best seen in <FIG>. More precisely, the first member <NUM> generally resides in a first plane <NUM>, and the second member <NUM> generally resides in a second plane <NUM> that is generally orthogonal to the first plane <NUM>.

In <FIG>, the first member <NUM> and the second member <NUM> have been spread apart along the lateral direction <NUM> to enable the suture <NUM> to pass through the channel <NUM> and into the capture hole <NUM>. This motion involves out-of-plane motion of each of the first member <NUM> and the second member <NUM>. An item that moves out-of-plane moves in a manner that removes it from the plane in which it was prior to the motion. Thus, a thin, flat object that rotates about an axis perpendicular to its large face moves in-plane. Likewise, such an object that moves in a direction parallel to its large face moves in-plane. However, if such an object rotates about an axis that is non-perpendicular to its large face, or moves along a direction nonparallel to its large face, such motion is out-of-plane.

The first member <NUM> and the second member <NUM> may each move out-of-plane to reach the configuration shown in <FIG> because each of the first and second members <NUM>, <NUM> moves out of the plane in which it naturally resides. Thus, the first member <NUM> moves out of the first plane <NUM> and the second member <NUM> moves out of the second plane <NUM>.

In <FIG>, the channel <NUM> is opened through a different mechanism. More specifically, the first arm <NUM> and the second arm <NUM> may be compressed toward each other. As a result, the walls of the channel <NUM> may generally flex apart to widen the channel <NUM>. This may be accomplished through the use of an instrument (not shown) that has a window or side walls that reduce in width, such that when the distal end <NUM> is advanced through the instrument, the first arm <NUM> and the second arm <NUM> are compressed against the side walls to open the channel <NUM>. Again, out-of-plane flexure of the first member <NUM> and the second member <NUM> has occurred to open the channel <NUM> sufficiently to accommodate passage of the suture <NUM>.

In an alternative embodiment (not shown), the walls of the channel <NUM> may be angled differently than shown in <FIG> to enhance this effect. For example, in place of the configuration of <FIG>, the walls of the channel <NUM> may be angled toward each other so that the channel <NUM> is narrower at the top than it is at the bottom. Thus, when the first arm <NUM> and the second arm <NUM> are compressed toward each other, the walls of the channel <NUM> may be brought into a more nearly parallel configuration, thereby increasing the width of the narrowest portion of the channel <NUM>.

The various implant manipulators shown and described in <FIG> may be used with a wide variety of instruments. In some embodiments, an actuator may be used to control advancement of the implant manipulator into and out of the tissue. Such actuators may be manually operated or drive through the use of motors and/or control systems. <FIG> illustrate a number of various instruments that may be used with rigid or flexible implant manipulators. Several of these instruments are designed for use with flexible implant manipulators that pass suture through tissue; those of skill in the art will readily comprehend how their use and configuration may be adapted to rigid implant manipulators and/or implant manipulators designed for use with other implants such as bone anchors, joint replacements, grafts, and the like.

Referring to <FIG>, a side elevation view illustrates an actuator, which takes the form of an instrument <NUM> that is used to pass the needle <NUM> into a desired location within tissues such that the distal end <NUM> is able to capture, retain, and reposition suture therein according to an embodiment of the invention. The instrument <NUM> is thus called a suture passer. The instrument <NUM> may have a proximal end <NUM>, a distal end <NUM>, and an intermediate portion <NUM>. The instrument may pass the distal end <NUM> between a pair of tissue grasping jaws including an upper jaw <NUM> and a lower jaw <NUM> at the distal end <NUM> of the instrument <NUM>.

The upper jaw <NUM> may pivot around a pin in the lower jaw <NUM> and rotate toward and away from the lower jaw <NUM>. The distal end <NUM> of the needle <NUM> may pass upward from the lower jaw <NUM> toward the upper jaw <NUM>. The upper jaw <NUM> may temporarily capture a strand of suture material that is ultimately retrieved by the suture capture feature <NUM> of the needle <NUM> and pulled back down toward the lower jaw <NUM>. A structure like that of <FIG> may optionally be used to temporarily retain the suture.

The proximal end <NUM> of the instrument <NUM> may include a chassis <NUM> that generally contains the mechanical workings (not shown) of the instrument <NUM>, a handle <NUM>, a first user control, which may take the form of a first trigger <NUM>, and a second user control, which may take the form of a second trigger <NUM>. According to one example, the second trigger <NUM> may be used to control actuation of the needle <NUM> through the instrument <NUM>, and the first trigger <NUM> may control actuation of the upper jaw <NUM> toward the lower jaw <NUM>. Thus, a surgeon may independently control grasping of tissue and puncture and suture retrieval through the tissue. Those of skill in the art will recognize that many other types of user controls may be used in the alternative to the first trigger <NUM> and the second trigger <NUM>, including sliders, push buttons, and the like. Additionally, in alternative embodiments, one or more than two user controls may be provided and may perform functions different from those recited above.

The intermediate portion <NUM> may have a shaft <NUM> that is of adequate length such that the handle <NUM> and the chassis <NUM> may remain outside the body while the distal end <NUM> is inserted through a working portal or cannula to reach a joint space, a wound, or another anatomical region that requires suturing.

Referring to <FIG>, the lower jaw <NUM> of the instrument <NUM> is shown in greater detail. <FIG>, side elevation and top elevation views, respectively, illustrate the lower jaw <NUM> of the instrument <NUM> in greater detail. <FIG> illustrate section views of various portions of the lower jaw <NUM>. The lower jaw <NUM> may have a bore <NUM> shaped to cause the needle <NUM> to bend as it moves through the lower jaw <NUM> in a manner similar to that of <FIG>.

In order to accomplish the varying cross-sectional shapes of the needle <NUM>, the lower jaw <NUM> may include three distinct sections including a first section <NUM>, a second section <NUM>, and a third section <NUM> as shown in <FIG>. The first section <NUM> may accommodate the needle <NUM> with its substantially undeflected V-shaped cross-sectional shape, as shown in <FIG>. The cross-sectional shape of the first section <NUM> may be relatively rectangular as shown in <FIG>.

The second section <NUM> may accommodate the needle <NUM> with its substantially flat, coplanar cross-sectional shape, as shown in <FIG>. The cross-sectional shape of the second section <NUM> may thus be a relatively thin, wide rectangular shape, as shown in <FIG>, by comparison with the first section <NUM>. In order to assist this shape change, a first transitional region <NUM> may be present between the first section <NUM> and the second section <NUM>. In this first transitional region <NUM>, the cross-sectional shape of the bore <NUM> gradually alters between the shape of the first section <NUM> and the shape of the second section <NUM>.

The third section <NUM> may then cause the needle <NUM> to revert back to the more rigid V-shaped configuration as it exits an aperture <NUM> of the lower jaw <NUM> as shown in <FIG>. In this third section <NUM>, the cross-sectional shape may be substantially V-shaped as shown in <FIG>. A second transitional region <NUM> may also exist between the second section <NUM> and the third section <NUM> to gradually force the cross-sectional shape of the needle <NUM> to change as it passes from the second section <NUM> to the third section <NUM>. Thus, the needle <NUM> may bend to extend upward, toward the upper jaw <NUM>, and yet retain sufficient stiffness at the aperture <NUM> to enable it to effectively pierce tissue. "Piercing" tissue relates to pushing a sharp feature into the tissue to form an opening in the tissue, as opposed to simply moving a feature into an existing hole in the tissue.

Referring to <FIG>, a side elevation view illustrates an instrument <NUM> according to one alternative embodiment. The instrument <NUM> may be a suture passer with a proximal end <NUM> and an intermediate portion <NUM> like those of <FIG>. However, the instrument <NUM> may have a distal end <NUM> with an upper jaw <NUM> and a lower jaw <NUM> that are configured differently from those of <FIG>.

The instrument <NUM> may pass an implant manipulator, such as the needle <NUM> of <FIG>, from the upper jaw <NUM> to the lower jaw <NUM>. The lower jaw <NUM> may temporarily capture a strand of suture material that is ultimately retrieved by the suture capture feature <NUM> of the needle <NUM> and pulled back up toward the upper jaw <NUM>. Thus, the upper jaw <NUM> may have a bore like the bore <NUM> of the instrument <NUM> of <FIG>.

As mentioned previously, the distal end <NUM> of the needle <NUM> may have the spine <NUM> intact, and may thus be resistant to flexure into the flat cross-sectional shape shown in <FIG> to permit bending of the distal end <NUM>. There are a number of alterations to the upper jaw <NUM> and the lower jaw <NUM> that can be made that would allow for the distal end <NUM> of the needle <NUM> to remain in the V-shaped configuration while the needle <NUM> only bends in the regions where the slot <NUM> exists (e.g., in the selectively bendable portion <NUM>).

According to one example, an instrument like the instrument <NUM> may have an upper jaw or a lower jaw with a movable distal tip that translates, slides, pivots, or rotates to move the distal tip of the needle, without deformation, from a first position substantially parallel to the long axis of the instrument to a second position substantially perpendicular to the long axis of the instrument. One such example will be shown and described in connection with <FIG>.

Referring to <FIG>, a variety of views illustrate a distal end <NUM> of an instrument (not shown) according to another embodiment of the invention. The distal end <NUM> may have an upper jaw <NUM> (or in other alternative embodiments, a lower jaw) with a main body <NUM> and a sliding tip <NUM>. The distal end <NUM> may facilitate re-orienting of the distal end <NUM> of the needle <NUM> in a manner that does not require significant bending of the distal end <NUM>.

The sliding tip <NUM> may have a first position and a second position. In the first position, the sliding tip <NUM> may be displaced from the main body <NUM> along the axis of the distal end <NUM> so that the needle <NUM> remains in a substantially straight configuration, proximal to distal, that is parallel to the upper jaw <NUM>. This first position is illustrated in <FIG>. In a second position shown in <FIG>, the sliding tip <NUM> may be retracted proximally such that it is positioned immediately adjacent to the main body <NUM>. The distal end <NUM> of the needle <NUM> is shown exiting the upper jaw <NUM> in a direction substantially perpendicular to the upper jaw <NUM>.

As best seen in <FIG> and <FIG>, The sliding tip <NUM> may have an interior contour <NUM> defining a curved wall <NUM>, a V-shaped wall <NUM> at the exit point of the upper jaw <NUM>, and a transitional region <NUM> where the interior contour <NUM> gradually transforms from the shape of the curved wall <NUM> to that of the V-shaped wall <NUM>.

As the distal end <NUM> of the needle <NUM> is advanced through the upper jaw <NUM>, or the upper jaw <NUM> is retracted, the distal end <NUM> of the needle <NUM> may initially begin to deflect downward as it contacts the curved wall <NUM> of the upper jaw <NUM>. The flexure may occur along the region of the needle <NUM> where the slot <NUM> exists, e.g., the selectively bendable portion <NUM>. The first arm <NUM> and the second arm <NUM> of the needle <NUM> may undergo a shape change from the V-shaped configuration (as in <FIG>) to a relatively flat configuration (as in <FIG>) such that the needle <NUM> can bend. As the needle <NUM> is further advanced, the distal end <NUM> may exit the upper jaw <NUM> at the V-shaped wall <NUM>.

As the selectively bendable portion <NUM> of the needle <NUM> reaches the V-shaped wall <NUM>, the first arm <NUM> and the second arm <NUM> may be forced back to a V-shaped configuration (as in <FIG>) as they slide along the interior contour <NUM>. The main body <NUM> of the upper jaw <NUM> may have an extending feature <NUM> with a peaked surface <NUM> that represents the interior portion of the V-shape, the exterior portion of which is provided by the V-shaped wall <NUM>, as shown in <FIG>. The V-shaped wall <NUM> and the peaked surface <NUM> may thus cooperate to force the first arm <NUM> and the second arm <NUM> of the needle <NUM> to exit the upper jaw <NUM> in the generally rigid V-shaped configuration. Two extension arms <NUM> may be in contact with the main body <NUM> of the upper jaw <NUM> to slidably couple the sliding tip <NUM> to the main body <NUM>. The extension arms <NUM> may be connected to an actuation rod (not shown) that connects to one of the user controls (not shown) of the instrument, allowing for the user to control the extension and/or retraction of the sliding tip <NUM> relative to the main body <NUM>.

In the alternative to positioning such a mechanism on the upper jaw <NUM>, a corresponding lower jaw <NUM> (not shown) may be modified to have a main body <NUM> and a tip <NUM> like those shown in <FIG>. Alternatively, the distal end <NUM> of the needle <NUM> may be captured inside a pivoting tip (not shown) of one of the jaws. As the pivoting tip pivots from a first position to a second position, the selectively bendable portion <NUM> of the needle <NUM> may flex and pivot around the curve while the distal end <NUM> remains in the V-shaped configuration.

The embodiments described above describe an instrument for which the needle may be inserted from the proximal end of the instrument and travels towards the distal end. However, in alternative embodiments, the needle may be inserted into the distal end of the instrument and moved proximally to seat in the proximal end.

Referring to <FIG>, a variety of views illustrate a distal end <NUM> of an actuator (not shown) according to another embodiment of the invention. As shown, the actuator may have an intermediate portion <NUM> in addition to the distal end <NUM>. The distal end <NUM> may have an upper jaw <NUM> and a lower jaw <NUM> that includes a main body <NUM> and a cartridge <NUM>. The cartridge <NUM> may be slidably inserted onto the end of the main body <NUM> A needle like the needle <NUM> of <FIG> may be pre-loaded in the cartridge <NUM> to provide an assembly <NUM> that can be inserted into the end of the main body <NUM> of the lower jaw <NUM>.

<FIG> illustrates one manner in which the assembly <NUM> may be inserted into engagement with the main body <NUM>. As shown, the proximal end <NUM> of the needle <NUM> may be inserted into the corresponding opening (not shown) in the main body <NUM> of the lower jaw <NUM>. The assembly <NUM> may need to be rotated to cause the needle <NUM> to flex such that the assembly <NUM> can be fully inserted into main body <NUM> as shown in <FIG>.

In general, the instrument of <FIG> may provide the benefit of avoiding the need to pass the distal end <NUM> through a nonlinear actuation pathway. Since the distal end <NUM> is positioned beyond the end of the bore that extends through the intermediate portion <NUM> and through the lower jaw <NUM>, it need not follow a curved pathway. Rather, the intermediate portion <NUM>, or more specifically, the selectively bendable portion <NUM>, may bend to orient the distal end <NUM> generally perpendicular to the length of the instrument, as shown in <FIG>.

In other examples of the disclosure (and not of the invention), an implant manipulator need not bend around a curve, but may instead remain in a rigid configuration as it translates along a single plane. As mentioned previously, the implant manipulator <NUM> and the implant manipulator <NUM> may both be substantially rigid. Such implant manipulators may be used in a wide variety of instruments.

Referring to <FIG>, various views illustrates another instrument <NUM>. The instrument <NUM> may also be a suture passer, and may use a rigid needle like the needle <NUM> of <FIG> to pass suture through tissue. The instrument <NUM> may have proximal end <NUM>, a distal end <NUM>, and an intermediate portion <NUM> between the proximal end <NUM> and the distal end <NUM>. The proximal end <NUM> may be similar to the proximal end <NUM> of the instrument <NUM> of <FIG>. Thus, the proximal end <NUM> may have a handle <NUM>, a first user control in the form of a first trigger <NUM>, and a second user control in the form of a second trigger <NUM>. The intermediate portion <NUM> may be similar to the intermediate portion <NUM>.

The distal end <NUM> of the instrument <NUM> may have a cutout section <NUM> and jaw <NUM> that pivots around a shaft or other pivot point proximate the distal terminus of the cutout section <NUM>. The cutout section <NUM> may provide a location for the tissue to be inserted between the distal end <NUM> of the needle <NUM>, which may reside within the interior of the intermediate portion <NUM> proximally of the cutout section <NUM>, and the jaw <NUM>.

The second trigger <NUM> may be used to rotate the jaw <NUM> between a first position in which the jaw <NUM> is oriented generally parallel to the intermediate portion <NUM>, as shown in <FIG>, and a second position in which the jaw <NUM> is oriented generally perpendicular to the intermediate portion <NUM>, as shown in <FIG>. The first trigger <NUM> may be used to actuate the needle <NUM> from a first position in which the needle <NUM> is disposed entirely, or nearly entirely, within the intermediate portion <NUM>, to a second position in which the distal end <NUM> of the needle <NUM> extends across the cutout section <NUM> to the jaw <NUM>. The needle <NUM> may be coupled at its proximal end <NUM> to a tab <NUM> that connects to a needle carriage device (not shown) that pushes and pulls the needle <NUM> between the two positions as the first trigger <NUM> is used.

<FIG> shows the jaw <NUM> in the first position as described above. The jaw <NUM> is substantially parallel to the intermediate portion <NUM>. This first position may be useful to manipulate the distal end <NUM> of the instrument <NUM> into a working cannula or other narrow access portal (not shown) and into the correct anatomical location because, in the first position, the profile of the distal end <NUM> of the instrument <NUM> is minimized.

<FIG> shows the jaw <NUM> in the second position as described above. The jaw <NUM> is substantially perpendicular to the intermediate portion <NUM>. This second position may be useful for suture passing steps as the distal end <NUM> of the needle <NUM> may need to pass into the jaw <NUM>. Further, this rotation of the jaw <NUM> may also allow the height of the jaw <NUM> along the transverse direction <NUM> to exceed the height of the intermediate portion <NUM>. A link <NUM> may be connected to the jaw <NUM> and to the second trigger <NUM> so that actuation of the second trigger <NUM> rotates the jaw <NUM> between the first and second positions.

<FIG> is an oblique view showing the jaw <NUM> in greater detail. A first set of pins <NUM> may be used to connect the jaw <NUM> to the cutout section <NUM> and provide a pivot point for the rotation of the jaw <NUM> relative to the remainder of the instrument <NUM>. Two aligned holes <NUM> may be used to connect the jaw <NUM> to the actuation link <NUM>. A window <NUM> may extend through the width of the jaw <NUM> to accommodate passage of distal end <NUM> of the needle <NUM>. The distal end of the window <NUM> may have a central post <NUM> that can be used to support the suture <NUM> and may be used to spread the suture capture feature <NUM> on the needle <NUM> as previously described. A slot <NUM> may be provided to temporarily capture a section of a suture such as the suture <NUM>. The narrow width of the slot <NUM> may enable the slot <NUM> to securely hold the suture <NUM> to temporarily capture it, while remaining able to release the suture <NUM> in response to application of a small removal force, such as that applied to the suture <NUM> such as when it is being retrieved by the needle <NUM>. The slot <NUM> may optionally have a boss or other positive feature (not shown); such as a bump, wedge, or bulge that provides a secondary constraint on the suture.

In <FIG>, a section of suture <NUM> is shown temporarily constrained within the slot <NUM>. The suture <NUM> may lay adjacent to the central post <NUM>. The suture <NUM> may be pre-loaded into the instrument <NUM> prior to use. Once the suture <NUM> has been pre-loaded onto the instrument <NUM>, the jaw <NUM> may be placed in the first position (<FIG>). The instrument <NUM> may then be inserted into a working cannula or other portal with access to the desired location, i.e., the anatomical space at which suturing is to be performed. The jaw <NUM> may then be actuated to the second position adjacent to and behind the piece of tissue <NUM> to be sutured, as shown in <FIG>.

<FIG> shows the needle <NUM> after it has been actuated to an extended position. The tips <NUM> of the needle <NUM> have punctured the tissue <NUM> and the distal-most portion of the distal end <NUM> has passed through the tissue <NUM> and into the window <NUM> of the jaw <NUM>. As the distal end <NUM> of the needle <NUM> is being extended into the jaw <NUM>, the suture <NUM> may translate into the suture capture feature <NUM>. The central post <NUM> may serve two purposes during this step of the procedure. First, the suture <NUM> may be prevented from being pushed distally by the advancing distal end <NUM> as the central post <NUM> serves as a stop that the suture <NUM> cannot be pushed past. Second, the central post <NUM> may be used to urge the first member <NUM> and the second member <NUM> of the distal end <NUM> to move apart (as shown in <FIG> and/or 11B), allowing the suture <NUM> to enter the capture hole <NUM>.

The needle <NUM> may then be retracted towards the proximal end <NUM> of the instrument <NUM> with the suture <NUM> retained in the capture hole <NUM> so that the suture <NUM> is drawn back through the tissue <NUM> as shown in <FIG>. The needle <NUM> may be retracted back into the intermediate portion <NUM> such that the suture <NUM> is compressed between the interior wall of the intermediate portion <NUM> and the needle <NUM>, which compression may more securely lock the suture <NUM> in place. As the distal end <NUM> of the instrument <NUM> is then removed from the body, the suture <NUM> may be retained securely so as to not be dislodged from the instrument <NUM>. Lastly, to remove the suture <NUM> from the instrument <NUM>, the needle <NUM> may need to be slightly advanced, such that one end of the suture <NUM> can be pulled along the transverse direction <NUM> (i.e., up or down with reference to <FIG>) and out of the capture hole <NUM>.

The instrument <NUM> provides a linear pathway for travel of the needle <NUM>; accordingly, use of the generally rigid needle <NUM> is suitable. In alternative embodiments, the instrument <NUM> may be modified to have a nonlinear actuation pathway for needle travel. For example, the intermediate portion <NUM> may be curved along a radius of curvature to enable the distal end <NUM> to move along an arcuate pathway through the body. Alternatively, the intermediate portion <NUM> may remain straight, but the needle may be guided along a nonlinear actuation pathway proximate the distal end <NUM>.

In such embodiments, a flexible needle like the needle <NUM> of <FIG> may be used. According to one alternative embodiment, shown in <FIG>, the needle <NUM> may need to travel along a pathway that curves at the distal end to provide a greater bite depth of tissue. In <FIG>, an instrument (not shown) may be configured generally similarly to the instrument <NUM> of <FIG>, except that the instrument of <FIG> has a distal end <NUM> and an intermediate portion <NUM> configured to carry out suturing with a greater bite depth in the tissue <NUM>. Thus, the distal end <NUM> of the needle <NUM> may exit the intermediate portion <NUM> at an upward angle. The distal end <NUM> may have a cutout section <NUM>, a jaw <NUM>, and a link <NUM> that operate in a manner generally similar to those of the instrument <NUM>.

A feature such as a ramp, bump, post, pin, or other feature may be positioned within the interior of the intermediate portion <NUM>, proximate its distal opening. The distal end <NUM> of the needle <NUM> may contact such a feature, which may then redirect the distal end <NUM> of the needle <NUM> as it exits the interior of the intermediate portion <NUM>. With this modified exit angle, the height of the jaw <NUM> (along the transverse direction <NUM> as shown in <FIG>) and/or location of the window <NUM> (not shown in <FIG>) may need to be altered from those of the jaw <NUM> of <FIG> so that the window <NUM> can accommodate passage of the angled distal end <NUM>.

<FIG> is a side elevation, section view illustrating an intermediate portion <NUM> of an instrument (not shown) according to another alternative embodiment of the invention. The needle <NUM> may exit the intermediate portion <NUM> through a window <NUM>, which may be on the upper surface of the intermediate portion <NUM>. This may allow the needle <NUM> to exit the intermediate portion <NUM> at a more proximal location, while still keeping the overall profile of the entire instrument substantially the same so that it still fits through the desired cannula or other portal to the working location within the body. If desired, one or more various features such as ramps, bumps, posts, pins or the like may be positioned within the interior of the intermediate portion <NUM> or outside the intermediate portion <NUM> to enable the needle <NUM> to move along the nonlinear actuation pathway shown in <FIG>.

In <FIG>, a perspective view illustrates an instrument <NUM> according to another embodiment of the invention. The instrument <NUM> may have a distal end <NUM> and intermediate portion <NUM> like those of the instrument <NUM> of <FIG>. However, the instrument <NUM> may also have a proximal end <NUM> that is different from the proximal end <NUM> of the instrument <NUM>.

The proximal end <NUM> of the instrument <NUM> may have a handle <NUM> with a straight style different from the pistol grip style illustrated in other figures herein. As with previous embodiments, the handle design of <FIG> may be used with a wide variety of user controls including push buttons, sliders, levers, triggers, or other similar mechanisms. In <FIG>, the proximal end <NUM> has a chassis <NUM> that generally contains the mechanical workings (not shown) of the instrument <NUM>. A first user control may take the form of a push button <NUM>, and a second user control may take the form of a slider <NUM>. The push button <NUM> and the slider <NUM> may perform functions similar to the first trigger <NUM> and the second trigger <NUM> of <FIG>. The distal end <NUM> of the instrument <NUM> may function in a manner similar to that of the instrument <NUM>. The instrument <NUM> may simply provide different ergonomics and user controls.

The instruments disclosed herein with upper and lower jaws, such as the instrument <NUM> and the instrument <NUM>, may have the ability to grasp the piece of tissue to be sutured prior to passing of the needle through the tissue. Such grasping may also be provided for instruments without such jaws like the instruments <NUM> and <NUM>.

Referring to <FIG>, a distal end <NUM> of an instrument (not shown) may have a cutout section <NUM>, a distal wall <NUM>, proximal jaw <NUM> that may be used to grasp the tissue prior to suturing. The proximal jaw <NUM> may extend distally in response to actuation of a user control at the proximal end (not shown) of the instrument until the section of tissue is pinched between the proximal jaw <NUM> and the distal wall <NUM>. The distal wall <NUM> may be formed as a single piece (i.e., unitarily formed) with the cutout section <NUM>, and may thus be a stationary feature. This may provide additional rigidity at the distal end <NUM>, particularly when the tissue is being pinched between the proximal jaw <NUM> and the distal wall <NUM>. Alternatively, the distal wall <NUM> may be replaced by a jaw that pivots relative to the cutout section <NUM> in a manner similar to that of the jaw <NUM> of <FIG>.

A suture passing instrument according to embodiments of the invention may also be used to place a continuous stitch through one or more pieces of tissue. This may be accomplished, for example, by housing two opposing needles in the distal end of the instrument. The needles may then be used to pass suture back and forth through the tissue.

<FIG> illustrate a distal end <NUM> of an instrument (not shown) according to another alternative embodiment, showing how a length of suture <NUM> may be passed from a lower jaw <NUM> to an upper jaw <NUM>. <FIG> shows the suture <NUM> temporarily captured in the distal end <NUM> of a lower needle <NUM> housed within the lower jaw <NUM>.

In <FIG>, the distal end <NUM> of the lower needle <NUM> is extended out of the lower jaw <NUM> carrying the suture <NUM> with it toward the upper jaw <NUM>. Once the distal end <NUM> of the lower needle <NUM> reaches the distal end <NUM> of an upper needle <NUM> housed in the upper jaw <NUM>, the suture <NUM> may be passed from the distal end <NUM> of the lower needle <NUM> to the distal end <NUM> of the upper needle <NUM>. Additional features such as posts, wedges, pushers, or the like (not shown) may be positioned in or on the upper jaw <NUM>, the lower jaw <NUM>, and/or on the needles <NUM> themselves to open one or both of the channel <NUM> of the lower needle <NUM> and the channel <NUM> of the upper needle <NUM> to facilitate passage of the suture <NUM> from the capture hole <NUM> of one needle <NUM> to the capture hole <NUM> of the other needle <NUM>.

In <FIG>, the lower needle <NUM> is retracted back into the lower jaw <NUM>, leaving the suture <NUM> in the upper needle <NUM>. This process may then be reversed to pass the suture <NUM> back down from the upper jaw <NUM> to the lower jaw <NUM>. The process may be repeated as many times as necessary to complete the continuous stitch. Each transfer of suture <NUM> to the opposing needle <NUM> may entail passage of the suture through the tissue. The distal end <NUM> may be moved along the lateral direction <NUM> and/or the longitudinal direction <NUM> between each transfer so that the repeated passage of suture through the tissue defines stitching in the tissue.

As previously described in connection with <FIG>, a flexible pusher such as the pusher <NUM> may be used to push or advance an implant through the body. One manner in which this may be done will be shown and described in connection with <FIG>.

Referring to <FIG>, a perspective view illustrates the pusher <NUM> is shown with a downward bend like that illustrated in <FIG> in connection with the needle <NUM>. The proximal end <NUM> and the distal end <NUM> of the pusher <NUM> may retain the V-shaped cross-sectional shape shown in <FIG>, while the slot <NUM> may allow the first arm <NUM> and the second arm <NUM> of the pusher <NUM> to rotate into a substantially coplanar configuration as in <FIG>. Thus, the selectively bendable portion <NUM> may bend in the transverse direction <NUM>.

The cross-sectional shape at the distal end <NUM> may be modified in a variety of ways, including the use of V-shaped, round, rectangular, square, oval, star, or hexagonal cross-sectional shapes. The shape at the distal end <NUM> may be dependent upon the implant it is designed to manipulate. In certain embodiments, the distal end <NUM> may have an implant interface (not shown) with various features that grip, interlock, or otherwise adhere to the implant until release is desired. The implant interface may include an active or passive connection mechanism including press-fits, collets, or tongue-groove systems, bayonet fittings, or any implant interface known in the art.

<FIG> demonstrate how a pusher <NUM> may be used to insert an implant in the form of a bone anchor <NUM> along a curved insertion pathway to reach a desired location. A hollow shaft <NUM> may house a pusher <NUM>, which may be flexible like the pusher <NUM> of <FIG>. The distal tip of the pusher <NUM> may interface with the bone anchor <NUM>, which may be designed to be pushed into bone.

In <FIG>, the pusher <NUM> may initially be retracted within the hollow shaft <NUM>. The bone anchor <NUM> may be placed on the surface of a cortical layer <NUM> of the bony implantation site. The pusher <NUM> may then be pushed or extended through the hollow shaft <NUM> using an actuator (not shown) on or proximate the hollow shaft <NUM> to push the bone anchor <NUM> through the cortical layer <NUM> and into a cancellous layer <NUM> of bone as shown in <FIG>. If desired, one or more features such as clips, clamps, bone screws, or the like may be used to temporarily dock hollow shaft <NUM> to the cortical layer <NUM> so that a counter force can be applied to the cortical layer <NUM> as the bone anchor <NUM> is driven through it.

Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the apparatus of the invention, the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment.

Claim 1:
An apparatus for manipulating a suture, the apparatus comprising:
a needle (<NUM>) comprising:
a proximal end (<NUM>) ;
a distal end (<NUM>) comprising a first tip and an implant interface (<NUM>) that is configured to retain a suture (<NUM>) by directly contacting the suture (<NUM>) to urge the suture (<NUM>) to or from a desired location within a body; and
an intermediate portion ( <NUM>) between the proximal (<NUM>) and distal (<NUM>) ends, the intermediate portion ( <NUM>) comprising a cross-sectional shape perpendicular to a length of the needle ( <NUM>), the cross-sectional shape extending along a nonlinear pathway (<NUM>, <NUM>) and comprising a thickness (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) perpendicular to the nonlinear pathway (<NUM>, <NUM>), wherein the thickness (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is substantially constant along a pathway length of the nonlinear pathway (<NUM>, <NUM>), wherein the cross-sectional shape is non-rectangular and non-circular, wherein the intermediate portion (<NUM>) comprises a selectively bendable portion (<NUM>) at which the intermediate portion (<NUM>) is designed to bend, wherein the cross-sectional shape of the selectively bendable portion (<NUM>) is variable between different configurations, and wherein the flexural rigidity of the selectively bendable portion (<NUM>) can be controlled through variation of the cross-sectional shape;
the apparatus further comprising a suture passer (<NUM>) comprising a user control that can be activated to urge the needle ( <NUM>) to move relative to the suture passer (<NUM>) such that the first tip pierces the tissue.