Patent Description:
The documents <CIT> and <CIT> disclose a cutaway formed at the distal end of the hollow tube.

<CIT> relates to a suture grasping device adapted to easily and conveniently grasp a length of suture at any point along the suture's length.

In many situations suture must be passed through tissue. In open surgical procedures, the suture is typically attached to a needle and the needle is then used to draw the suture through the tissue. However, in closed surgical procedures (e.g., so-called "keyhole" surgeries, where an interior surgical site is accessed through a narrow cannula), it can be difficult to advance a needle (and particularly a curved needle) to the interior surgical site, and it can be even more difficult to maneuver the needle about the interior surgical site. Furthermore, in closed surgical procedures, it is frequently necessary to advance the suture through tissue, and then to retrieve the suture on the far side of the tissue, so that the suture can thereafter be drawn back through the tissue, e.g., at a second point of penetration. Conventional needles are typically inadequate for these situations.

On account of the foregoing, in closed surgical procedures, it is common to use a suture passer to pass suture through tissue, e.g., at a remote surgical site. Such suture passers are dedicated suture passing instruments generally comprising a shaft, a tissue-penetrating and suture-carrying working tip set at the distal end of the shaft, and a handle set at the proximal end of the shaft. However, such suture passers all tend to suffer from one or more deficiencies, including but not limited to: (i) size; (ii) a need to place the suture adjacent to an edge of the tissue; (iii) difficulty in picking up suture on the far side of the tissue; (iv) complexity of operation; (v) cost of manufacture, etc..

Thus there is a need for a new and improved method and apparatus for passing suture through tissue which does not suffer from one or more of the disadvantages associated with the prior art.

The present disclosure provides a new and improved method and apparatus for passing suture through tissue.

In one form of the present disclosure, there is provided a suture passer comprising:.

In another form of the present invention, there is provided a method for passing suture through an object, the method comprising:.

In another form of the present disclosure, there is provided a suture passer comprising:.

In another form of the present disclosure, there is provided a method for passing suture through an object, the method comprising:.

These and other objects and features of the present disclosure will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the disclosure, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:.

The present disclosure provides a new and improved method and apparatus for passing suture through tissue. The Novel Suture Passer.

Looking first at <FIG>, there is shown a novel suture passer <NUM> formed in accordance with the present disclosure.

Suture passer <NUM> generally comprises a hollow tube <NUM> and a clamping rod <NUM> slidably disposed within the lumen of hollow tube <NUM>, as will hereinafter be discussed in further detail.

More particularly, hollow tube <NUM> comprises a distal end <NUM> preferably terminating in a sharp point <NUM>, and a proximal end <NUM> preferably terminating in a handle <NUM>, with a lumen <NUM> extending therebetween. It will be appreciated that the pointed hollow tube <NUM> essentially comprises a hollow needle adapted to pierce tissue.

Hollow tube <NUM> further comprises a window <NUM> which extends radially into the hollow tube and communicates with lumen <NUM>. Window <NUM> is sized so as to selectively receive a suture S therein, as will hereinafter be discussed in further detail. Window <NUM> preferably comprises an inclined distal surface <NUM> and an inclined proximal surface <NUM>. Preferably, distal surface <NUM> and proximal surface <NUM> are inclined in the same direction, and preferably both surfaces are inclined distally (e.g., in the manner shown in <FIG>). The forward incline of inclined distal surface <NUM> allows suture to more easily pass into and out of window <NUM>. The forward incline of inclined proximal surface <NUM> provides an undercut which helps to trap the suture S between the clamping surface <NUM> of clamping rod <NUM> and the inclined proximal surface <NUM> of window <NUM>, as will hereinafter be discussed in further detail.

Hollow tube <NUM> is preferably formed out of a substantially rigid material (e.g., stainless steel) so as to maintain rigidity when passing through tissue, particularly relatively tough fibrous tissue (e.g., the labrum of the hip).

In one preferred form of the present disclosure, the distal end <NUM> of hollow tube <NUM> is curved, however, it should be appreciated that hollow tube <NUM> can be formed in other configurations well known in the art (e.g., straight, etc.).

Clamping rod <NUM> comprises a distal end <NUM> (<FIG>) and a proximal end <NUM> (<FIG>). Distal end <NUM> of clamping rod <NUM> is bifurcated so as to form a first arm <NUM> and a second arm <NUM>.

First arm <NUM> comprises the aforementioned clamping surface <NUM>, with clamping surface <NUM> extending radially from the longitudinal axis of clamping rod <NUM>. Clamping surface <NUM> may take the form of a hook, as shown in <FIG>. This hook helps trap the suture S between clamping surface <NUM> of clamping rod <NUM> and inclined proximal surface <NUM> of window <NUM>, in the manner shown in <FIG> and <FIG>.

Second arm <NUM> extends parallel to first arm <NUM> when clamping rod <NUM> is disposed within lumen <NUM> of hollow tube <NUM>, with second arm <NUM> terminating proximally of first arm <NUM>, shy of clamping surface <NUM>.

Second arm <NUM> is outwardly biased so that when second arm <NUM> advances past window <NUM>, second arm <NUM> passes radially outwardly through window <NUM> so as to project at an angle of approximately <NUM>-<NUM> degrees relative to the adjacent longitudinal axis of first arm <NUM> (<FIG>) (i.e., the longitudinal axis of first arm <NUM> at the point adjacent to where second arm <NUM> advances outwardly through window <NUM>), and more preferably at an angle of approximately <NUM>-<NUM> degrees to the instantaneous longitudinal axis of first arm <NUM>, whereby to create a funnel region <NUM> (<FIG>) between hollow tube <NUM> and second arm <NUM> when second arm <NUM> extends out window <NUM>. To this end, second arm <NUM> is preferably formed out of a material consistent with this spring bias (e.g., a superelastic material such as Nitinol, etc.). In one preferred form of the disclosure, the entire clamping rod <NUM> is formed out of a superelastic material such as Nitinol.

The proximal end <NUM> of clamping rod <NUM> extends through lumen <NUM> of hollow tube <NUM> and is connected to an actuator <NUM> (<FIG>) which is movably mounted to handle <NUM>, such that movement of actuator <NUM> relative to handle <NUM> will cause movement of clamping rod <NUM> relative to hollow tube <NUM>.

It will be appreciated that, on account of the foregoing construction, a piece of suture S may be clamped to the distal end of suture passer <NUM> by (i) moving clamping rod <NUM> to the position shown in <FIG> and <FIG> (e.g., by moving actuator <NUM> distally relative to handle <NUM>) so that clamping surface <NUM> of first arm <NUM> is distal to window <NUM>, and so that second arm <NUM> extends out of window <NUM>; (ii) positioning the suture S in window <NUM> (<FIG>); and (iii) moving clamping rod <NUM> proximally (e.g., by moving actuator <NUM> proximally relative to handle <NUM>) so as to cause clamping surface <NUM> of first arm <NUM> to clamp suture S against proximal surface <NUM> of window <NUM>, as shown in <FIG> and <FIG>. In this respect it will be appreciated that the creation of the funnel region <NUM> (established between hollow tube <NUM> and the extended second arm <NUM>) at the mouth of window <NUM> facilitates guidance of suture S into window <NUM>, as shown in <FIG>.

It will also be appreciated that, on account of the foregoing construction, a clamped piece of suture may thereafter be released from suture passer <NUM> by (a) moving clamping rod <NUM> distally (<FIG>) so as to space clamping surface <NUM> of first arm <NUM> away from proximal surface <NUM> of window <NUM>; and (b) causing suture S to be withdrawn from window <NUM> (<FIG>), either by moving suture S relative to suture passer <NUM> or by moving suture passer <NUM> relative to suture S or by moving both suture S and suture passer <NUM> relative to one another.

It should be appreciated that, in one preferred form of the invention, when clamping rod <NUM> is moved proximally, both first arm <NUM> and second arm <NUM> are disposed within lumen <NUM> of hollow tube <NUM>, so that the distal end of suture passer <NUM> presents a smooth outer surface, whereby to facilitate passage of the distal end of suture passer <NUM> through tissue.

In one preferred form of the present disclosure, and looking now at <FIG>, the novel suture passer <NUM> can be used to pass suture S from the near side of tissue T to the far side of tissue T (i.e., in an "antegrade" manner).

More particularly, the preliminary loading of suture S into suture passer <NUM> may be performed away from the surgical site (e.g., outside of the patient) or it may be performed adjacent to the near side of the tissue T which is to be sutured (e.g., inside of the patient). As seen in <FIG>, clamping rod <NUM> is advanced to its most distal position so that second arm <NUM> advances out of window <NUM>, whereby to project out of the axis of hollow tube <NUM> and create the aforementioned funnel region <NUM>. Suture S is then guided into window <NUM> using this funnel effect, as seen in <FIG>, either by moving suture S relative to suture passer <NUM> or by moving suture passer <NUM> relative to suture S or by moving both suture S and suture passer <NUM> relative to one another. Clamping rod <NUM> is then retracted proximally so that clamping surface <NUM> clamps suture S between clamping surface <NUM> of first arm <NUM> and proximal surface <NUM> of window <NUM>.

Suture passer <NUM> is then advanced distally so that window <NUM> passes through tissue T, whereby to carry suture S through the tissue (<FIG>). With suture S extending through tissue T, and looking now at <FIG>, clamping rod <NUM> is advanced distally so that clamping surface <NUM> is disposed distal to window <NUM>, thereby releasing suture S from suture passer <NUM>. Suture passer <NUM> and/or suture S are then manipulated so that suture S is clear of window <NUM> (<FIG>). Clamping rod <NUM> is then moved proximally so as to retract first arm <NUM> and second arm <NUM> back into hollow tube <NUM>. Suture passer <NUM> may then be withdrawn back through tissue T, leaving suture S extending through tissue T, as shown in <FIG>.

In another preferred form of the present disclosure, and looking now at <FIG>, the novel suture passer <NUM> can be used to draw suture S from the far side of tissue T to the near side of tissue T (i.e., in a "retrograde" manner).

More particularly, in this form of the invention, the suture S is loaded into suture passer <NUM> on the far side of the tissue T. This is done by first passing suture passer <NUM> through tissue T so that window <NUM> resides on the far side of the tissue, and then moving clamping rod <NUM> distally so that second arm <NUM> extends out of window <NUM>, substantially perpendicularly to hollow tube <NUM>, whereby to create the aforementioned funnel region <NUM> (<FIG> and <FIG>). This funnel effect is then used to guide free suture (disposed on the far side of tissue T) into window <NUM> (see <FIG>), either by moving suture S relative to suture passer <NUM> or by moving suture passer <NUM> relative to suture S or by moving both suture S and suture passer <NUM> relative to one another. If desired, the suture S may be tensioned so as to help draw it into the window <NUM>.

Next, clamping rod <NUM> is retracted proximally so as to releasably secure suture S between clamping surface <NUM> and proximal surface <NUM> of window <NUM> (<FIG>). Hollow tube <NUM> is then retracted proximally through tissue T, carrying suture S therethrough (<FIG>). If desired, suture S can then be released from suture passer <NUM> by moving clamping rod <NUM> distally (<FIG> and <FIG>).

Significantly, by alternating the aforementioned antegrade suture passing procedure (<FIG>) with the aforementioned retrograde suture passing procedure (<FIG>), with the needle "plunges" being laterally spaced from one another in the tissue (<FIG>), a mattress stitch may be placed in the tissue (<FIG>).

If desired, the novel suture passer <NUM> may also be used to pass suture S around a side edge of the tissue T, rather than passing the suture S through the tissue. By way of example but not limitation, if the hollow tube <NUM> is passed around the side edge of the tissue (rather than through it), the suture passer could then be used to retrieve the suture on the far side of the tissue and draw it back around the side edge of the tissue so that the suture is brought to the near side of the tissue.

As described above, the novel suture passer <NUM> has the ability to both pass (advance) and retrieve (draw) the suture S through and/or around the tissue in a continuous series of steps. This allows the surgeon to complete the desired suture passing without having to remove the suture passer <NUM> from the portal through which the suture passer <NUM> is being used. Significantly, this passing/retrieving process can be accomplished with a single instrument, rather than requiring one instrument for passing and a separate instrument for retrieving. This offers significant advantages in convenience and in reducing surgery time.

As noted above, clamping surface <NUM> of clamping rod <NUM> may take the form of a hook, as shown in <FIG>. This hook may have various degrees of depth and return, as seen in <FIG>. Alternatively, clamping surface <NUM> may be substantially flat, as shown in <FIG>.

In addition, and looking now at <FIG> and <FIG>, if desired, second arm <NUM> of suture passer <NUM> may include a plurality of suture-engaging projections <NUM> on its distal side. Suture-engaging projections <NUM> allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm <NUM>, whereby to facilitate manipulation of suture S via engagement with second arm <NUM>. Thus, for example, with the construction shown in <FIG> and <FIG>, if the user needs to move the suture S about a surgical site, the user can "grip" the suture S with the suture-engaging projections <NUM> of second arm <NUM> and "drag" the suture S into a desired position. In another example, the suture-engaging projections <NUM> of second arm <NUM> can assist in dragging suture S into window <NUM>. More particularly, as the clamping rod <NUM> is moved proximally in hollow tube <NUM>, the second arm <NUM> retracts into the lumen of the hollow tube <NUM>. As it does so, if the suture S is in contact with the suture-engaging projections <NUM> of second arm <NUM>, suture S will be drawn into window <NUM>. Once in window <NUM>, the suture S is then clamped between clamping surface <NUM> of clamping rod <NUM> and inclined proximal surface <NUM> of window <NUM> as described above.

Alternatively, and looking now at <FIG> and <FIG>, second arm <NUM> of suture passer <NUM> may include a plurality of suture-engaging projections <NUM> on its proximal side. Again, suture-engaging projections <NUM> allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm <NUM>, whereby to facilitate manipulation of suture S via engagement with second arm <NUM>.

If desired, suture-engaging projections <NUM> may also be provided on both the distal and proximal sides of second arm <NUM>, and/or on one or both of the lateral sides of second arm <NUM>.

It will be appreciated that suture-engaging projections <NUM> essentially constitute a friction-enhancing surface on second arm <NUM> so as to allow second arm <NUM> to engage and "drag" suture S about a surgical site. To this end, it will also be appreciated that the friction-enhancing surface(s) on second arm <NUM> may be formed with a variety of geometries, e.g., barbs, fingers, ribs, threads or other surface texturing which increases the frictional aspects of second arm <NUM> at a desired location or locations.

Furthermore, if desired, the suture passer may be constructed so that the suture S is slidably captured - but not clamped - between clamping surface <NUM> of clamping rod <NUM> and inclined proximal surface <NUM> of window <NUM>. In this form of the disclosure, suture S is slidably captured between the two surfaces (i.e., clamping surface <NUM> and proximal surface <NUM>), in the manner shown in <FIG>. In this form of the disclosure, clamping rod <NUM> may be limited in its proximal travel (e.g., by means of interaction between actuator <NUM> and handle <NUM>) in order to provide a gap sufficient to slidingly capture, but not bind, suture S. This gap may be equal to, or larger than, the diameter of suture S.

Alternatively, if desired, the clamping rod can be configured to pierce the suture when the clamping rod is moved proximally, as shown in <FIG>. This spearing of the suture can enhance clamping of the suture S to the suture passer <NUM>. By way of example but not limitation, first arm <NUM> of clamping rod <NUM> may include a pointed return <NUM>, with pointed return <NUM> being configured and located such that it will spear suture S when clamping rod <NUM> is moved proximally.

It should be appreciated that the lengths of the first and second arms <NUM>, <NUM> of clamping rod <NUM> can vary from the construction shown in <FIG>. By way of example but not limitation, in one preferred form of the disclosure, the distance between the distal tip of second arm <NUM> and clamping surface <NUM> is approximately the length of window <NUM>, as shown in <FIG>. In another preferred form of the invention, only a nominal gap is provided between the distal tip of second arm <NUM> and clamping surface <NUM> (<FIG>). This construction can provide for improved capturing of suture S to suture passer <NUM>.

In another form of the present disclosure, suction may be applied to lumen <NUM> of hollow tube <NUM> proximal to window <NUM>. This suction will draw fluid into window <NUM>, and the fluid entering window <NUM> will assist suture S in seating itself into window <NUM> as the suture S approaches window <NUM>.

In another form of the present disclosure, fluid is delivered down lumen <NUM> of hollow tube <NUM> so as to assist ejection of suture S from window <NUM> once the clamping rod <NUM> has released suture S.

In yet another form of the present disclosure, hollow tube <NUM> comprises a second window <NUM> opposite first window <NUM>, and the distal end of clamping rod <NUM> is trifurcated so as to form a first arm <NUM> carrying a pair of clamping surfaces <NUM> and a pair of second arms <NUM>, with each of the second arms <NUM> being outboard of first arm <NUM> and being biased out a window <NUM>. Thus, with this construction, suture can be clamped on either side of hollow tube <NUM>.

In another form of the present disclosure, the suture passer may further comprise a push rod to assist in ejecting suture S from window <NUM>. The push rod may be a component separate from clamping rod <NUM> (but slidably movable relative thereto), or it may be integrated with clamping rod <NUM> (e.g., slidably movable thereon).

Looking next at <FIG>, it is also possible to form novel suture passer <NUM> so that (i) first arm <NUM> is shorter than second arm <NUM>, and (ii) clamping surface <NUM> is formed on the outwardly biased second arm <NUM> (rather than on first arm <NUM>). In this form of the disclosure, funnel region <NUM> is formed between the distal end of shaft <NUM> and first arm <NUM>. <FIG> show the novel suture passer of <FIG> securing a suture S to the distal end of the suture passer.

Furthermore, if desired, where clamping surface <NUM> is formed on the outwardly biased second arm <NUM> (e.g., in the manner shown in <FIG> and <FIG>), first arm <NUM> may be omitted entirely, in which case the distal end of clamping rod <NUM> preferably comprises only outwardly biased second arm <NUM>.

In another form of the present disclosure, and looking now at <FIG> novel suture passer <NUM> may be constructed so that first arm <NUM> (carrying clamping surface <NUM>) is outwardly biased, so that first arm <NUM> (and clamping surface <NUM>) extends out window <NUM> when clamping rod <NUM> is moved distally. In this form of the disclosure, the funnel region <NUM> is formed between the distal end of shaft <NUM> and first arm <NUM>. <FIG> show the novel suture passer of <FIG> securing a suture S to the distal end of the suture passer.

Furthermore, if desired, where first arm <NUM> is outwardly biased and carries clamping surface <NUM> (e.g., in the manner shown in <FIG> and <FIG>), second arm <NUM> may be omitted entirely, in which case the distal end of clamping rod <NUM> preferably comprises only outwardly biased first arm <NUM> (with clamping surface <NUM>).

In still another form of the present disclosure, and looking now at <FIG>, novel suture passer <NUM> may be constructed so that both first arm <NUM> (carrying clamping surface <NUM>) and second arm <NUM> are outwardly biased, so that both first arm <NUM> (and clamping surface <NUM>) and second arm <NUM> extend out window <NUM> when clamping rod <NUM> is moved distally. In this form of the invention, funnel region <NUM> is formed between first arm <NUM> and second arm <NUM>. <FIG> show the novel suture passer of <FIG> securing a suture S to the distal end of the suture passer.

In another form of the present disclosure, and looking now at <FIG>, window <NUM> may be eliminated, and clamping rod <NUM> may clamp suture S against the distal end surface <NUM> of hollow tube <NUM>.

Again, if desired, and looking now at <FIG> and <FIG>, second arm <NUM> of suture passer <NUM> may include a plurality of suture-engaging projections <NUM> on its distal side. As noted above, suture-engaging projections <NUM> allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm <NUM>, whereby to facilitate manipulation of suture S via engagement with second arm <NUM>. Thus, for example, with the construction shown in <FIG> and <FIG>, if the user needs to move the suture S about a surgical site, the user can "grip" the suture S with the suture-engaging projections <NUM> of second arm <NUM> and "drag" the suture S into a desired position. In another example, the suture-engaging projections <NUM> of second arm <NUM> can assist in dragging suture S against the distal end of hollow tube <NUM>. More particularly, as the clamping rod <NUM> is moved proximally in hollow tube <NUM>, the second arm <NUM> retracts into the lumen of hollow tube <NUM>. As it does so, if the suture S is in contact with the suture-engaging projections <NUM> of second arm <NUM>, suture S will be drawn into engagement with the distal end of hollow tube <NUM> and then clamped in place by first arm <NUM>.

Alternatively, if desired, second arm <NUM> of suture passer <NUM> may include a plurality of suture-engaging projections <NUM> on its proximal side (e.g., in a manner analogous to that shown in <FIG> and <FIG>). Again, suture-engaging projections <NUM> allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm <NUM>, whereby to facilitate manipulation of suture S via engagement with second arm <NUM>.

Again, it will be appreciated that, if desired, suture-engaging projections <NUM> may also be provided on both the distal and proximal sides of second arm <NUM>, and/or on one or both lateral sides of second arm <NUM>.

It will be appreciated that suture-engaging projections <NUM> essentially constitute a suture engaging surface on second arm <NUM> so as to allow second arm <NUM> to engage and "drag" suture S about a surgical site. To this end, it will also be appreciated that the suture engaging surface(s) on second arm <NUM> may be formed with a variety of geometries, e.g., barbs, fingers or other surface texturing which increases the frictional aspects of second arm <NUM> at a desired location or locations.

Furthermore, if desired, and looking now at <FIG>, the distal end surface <NUM> of hollow tube <NUM> can be disposed substantially perpendicular to the longitudinal axis of hollow tube <NUM>, whereby to enhance clamping of suture S against distal end surface <NUM> of hollow tube <NUM>. In this construction, it may be desirable to provide a sharp point <NUM> to the distal end of first arm <NUM>, in order to facilitate passage of the suture passer through tissue.

As noted above, suture passer <NUM> preferably comprises a handle <NUM>, and handle <NUM> preferably comprises an actuator <NUM> which actuates clamping rod <NUM> so as to clamp and/or release suture S. If desired, actuator <NUM> may comprise a lock or detent which maintains the position of clamping rod <NUM> relative to hollow tube <NUM>. For example, the lock or detent may hold the clamping rod in a distal position and/or in a proximal position (e.g., while it is clamping suture S).

Actuator <NUM> may also comprise a spring to bias clamping rod <NUM> proximally or distally. In one preferred form of the disclosure, this spring biases the clamping rod in a proximal direction (for example, to clamp suture S between clamping surface <NUM> and inclined proximal surface <NUM>).

Looking next at <FIG>, there is shown a novel suture passer <NUM> also formed in accordance with the present disclosure. Suture passer <NUM> will sometimes hereinafter be referred to as the "spear" suture passer.

More particularly, the spear suture passer <NUM> generally comprises an outer shaft tube <NUM>, an inner guide tube <NUM> fixedly disposed within the interior of outer shaft tube <NUM>, and a suture spear <NUM> slidably disposed within the lumen of inner guide tube <NUM>, as will hereinafter be discussed in further detail.

More particularly, outer shaft tube <NUM> comprises a distal end <NUM> preferably terminating in a sharp point <NUM>, and a proximal end <NUM> preferably terminating in a handle <NUM>, with a lumen <NUM> extending therebetween. It will be appreciated that the pointed outer shaft tube <NUM> essentially comprises a hollow needle adapted to pierce tissue.

Outer shaft tube <NUM> further comprises a window <NUM> which extends radially into the outer shaft tube and communicates with lumen <NUM>. Window <NUM> is sized so as to selectively receive a suture S therein, as will hereinafter be discussed in further detail. Window <NUM> comprises a pair of distal surfaces <NUM>, a pair of proximal surfaces <NUM>, and a pair of side surfaces <NUM>. Preferably, distal surfaces <NUM> and proximal surfaces <NUM> extend substantially perpendicular to the longitudinal axis of outer shaft tube <NUM> (<FIG>), and side surfaces <NUM> preferably extend substantially parallel to the longitudinal axis of outer shaft tube <NUM> (<FIG>). Distal surfaces <NUM> are preferably spaced from proximal surfaces <NUM> by a distance which is somewhat larger than the diameter of suture S, so that window <NUM> provides an adequate seat for suture S, as will hereinafter be discussed in further detail.

Outer shaft tube <NUM> is preferably formed out of a substantially rigid material (e.g., stainless steel) so as to maintain rigidity when passing through tissue, particularly relatively tough fibrous tissue (e.g., the labrum of the hip).

In one preferred form of the present disclosure, the distal end <NUM> of outer shaft tube <NUM> is curved (see, for example, <FIG>, <FIG>), however, it should also be appreciated that outer shaft tube <NUM> can be formed in other configurations well known in the art (e.g., straight, etc.).

Inner guide tube <NUM> comprises a distal end <NUM> (<FIG>) and a proximal end <NUM> (<FIG>), with a lumen <NUM> extending therebetween. Inner guide tube <NUM> is fixedly disposed within outer shaft tube <NUM> so that the distal end <NUM> of inner guide tube <NUM> terminates proximal to window <NUM> in outer shaft tube <NUM>, with lumen <NUM> of inner guide tube <NUM> being substantially aligned with the center of window <NUM>. The distal end <NUM> of inner guide tube <NUM> preferably terminates just proximal to window <NUM> of outer shaft tube <NUM>. See, for example, <FIG>, <FIG>. As will hereinafter be discussed, inner guide tube <NUM> acts as a guide and stiffening member for suture spear <NUM>, which is selectively extendable out of the inner guide tube (and hence selectively extendable across window <NUM>) and selectively withdrawable back into the inner guide tube (and hence selectively withdrawable out of window <NUM>).

Suture spear <NUM> comprises a distal end <NUM> (<FIG>) and a proximal end <NUM> (<FIG>). Distal end <NUM> of suture spear <NUM> terminates in a point <NUM>. It will be appreciated that suture spear <NUM> essentially comprises a needle which, as will hereinafter be discussed, is adapted to pierce suture. Suture spear <NUM> is slidably disposed within lumen <NUM> of inner guide tube <NUM>, such that suture spear <NUM> can extend across window <NUM> (<FIG>) or be withdrawn from window <NUM> (<FIG>). Preferably the proximal end <NUM> of suture spear <NUM> extends out of the proximal end <NUM> of inner guide tube <NUM> and is connected to an actuator <NUM> (e.g., a thumb slide) which is movably mounted to handle <NUM>, such that movement of actuator <NUM> relative to handle <NUM> will cause movement of suture spear <NUM> relative to inner guide tube <NUM> (and hence relative to outer shaft tube <NUM>). Specifically, movement of actuator <NUM> relative to handle <NUM> will cause the distal end of suture spear <NUM> to intrude across, or be withdrawn from, window <NUM> of outer shaft tube <NUM>.

It should be appreciated that the distal end of inner guide tube <NUM> is positioned within outer shaft tube <NUM> so that the inner guide tube (and hence the suture spear <NUM>) is aligned with a suture S that is laid in window <NUM> so as to ensure that suture spear <NUM> can securely pierce the suture S, as will hereinafter be discussed.

It will be appreciated that, on account of the foregoing construction, a piece of suture S may be clamped to the distal end of suture passer <NUM> by (i) moving suture spear <NUM> proximally so that the distal end <NUM> of suture spear <NUM> is withdrawn from window <NUM> of outer shaft tube <NUM>, in the manner shown in <FIG> (e.g., by moving actuator <NUM> proximally relative to handle <NUM>); (ii) positioning the suture S in window <NUM> (<FIG>); and (iii) moving suture spear <NUM> distally (e.g., by moving actuator <NUM> distally relative to handle <NUM>) so as to cause suture spear <NUM> to "spear" (e.g., penetrate) suture S, as shown in <FIG>, whereby to secure suture S to suture passer <NUM>.

It will also be appreciated that, on account of the foregoing construction, a speared piece of suture S (<FIG>) may thereafter be released from suture passer <NUM> by (a) moving suture spear <NUM> proximally (<FIG>) so as to "unspear" suture S; and (b) causing suture S to be withdrawn from window <NUM>.

More particularly, the preliminary loading of suture S into suture passer <NUM> may be performed away from the surgical site (e.g., outside of the patient) or it may be performed adjacent to the near side of the tissue T which is to be sutured (e.g., inside of the patient). As discussed previously, suture S may be loaded into suture passer <NUM> by retracting suture spear <NUM> out of window <NUM> of outer shaft tube <NUM> (<FIG>), guiding suture S into window <NUM> (<FIG>), and then advancing suture spear <NUM> distally through suture S (<FIG>), whereby to secure suture S to suture passer <NUM>.

Suture passer <NUM> is then advanced distally so that window <NUM> passes through tissue T, whereby to carry suture S through the tissue (<FIG>). With suture S extending through tissue T, and looking now at <FIG>, suture spear <NUM> is retracted proximally so as to release suture S from suture passer <NUM>, and then suture passer <NUM> and/or suture S are manipulated so that suture S is clear of window <NUM> (<FIG>). Suture passer <NUM> may then be withdrawn back through tissue T, leaving suture S extending through tissue T, as shown in <FIG>.

In another preferred form of the present disclosure, the spear suture passer <NUM> can be used to draw suture S from the far side of tissue T to the near side of tissue T (i.e., in a "retrograde" manner).

More particularly, in this form of the disclosure, the suture S is loaded into suture passer <NUM> on the far side of the tissue T. This is done by first passing suture passer <NUM> through tissue T so that window <NUM> resides on the far side of the tissue, and then moving suture spear <NUM> proximally so that suture spear <NUM> is withdrawn from window <NUM> (if the suture spear has not already been withdrawn from window <NUM>). Suture S (disposed on the far side of tissue T) is then positioned into window <NUM>, and suture spear <NUM> is advanced distally so as to spear suture S and secure the suture to suture passer <NUM>. Outer shaft tube <NUM> is then retracted proximally through tissue T, carrying suture S therethrough. If desired, suture S can then be released from suture passer <NUM> by moving suture spear <NUM> distally.

Significantly, by alternating the aforementioned antegrade suture passing procedure (<FIG>) with the aforementioned retrograde suture passing procedure (discussed in the paragraph immediately preceding this paragraph), with the needle "plunges" being laterally spaced from one another in the tissue, a mattress stitch may be placed in the tissue, as will be appreciated by one skilled in the art.

If desired, the spear suture passer <NUM> may also be used to pass suture S around a side edge of the tissue T, rather than passing the suture S through the tissue. By way of example but not limitation, if the outer shaft tube <NUM> is passed around the side edge of the tissue (rather than through the tissue), the suture passer could then be used to retrieve the suture on the far side of the tissue and draw it back around the side edge of the tissue so that the suture is brought to the near side of the tissue.

If desired, the function of the inner guide tube <NUM> can be replaced by a rod <NUM> with a slot <NUM>, as shown in <FIG>. This rod <NUM> could also have other cross-sectional shapes (such as that of a ribbon, etc.) that act to constrain the suture spear <NUM> to the desired position relative to the window <NUM>. This positioning scheme can also take the form of multiple wires filling the space where the suture spear is desired not to go.

The function of inner guide tube <NUM> can also be incorporated into the outer shaft tube <NUM>. For example, the outer shaft tube <NUM> can have a lumen <NUM> which is offset towards window <NUM>, e.g., as shown in <FIG>.

Additionally, suture spear <NUM> can occupy the entire internal diameter of lumen <NUM> of outer shaft tube <NUM>. In this embodiment, and as shown in <FIG>, the suture spear <NUM> is a rod with a sharpened feature <NUM> (e.g., a point) located in the window <NUM>. In this embodiment, the inner guide tube <NUM> is not required.

Looking next at <FIG>, there is shown a novel suture passer <NUM> formed in accordance with the present disclosure. Suture passer <NUM> generally comprises a hollow tube <NUM> and a clamping rod <NUM> slidably disposed within the lumen of hollow tube <NUM>, as will hereinafter be discussed in further detail.

Hollow tube <NUM> further comprises a cutaway <NUM> disposed just proximal to sharp point <NUM> and which communicates with lumen <NUM>. Cutaway <NUM> preferably comprises a pair of longitudinally-extending edges <NUM> which terminate at their proximal ends at a circumferentially-extending edge <NUM>. Preferably circumferentially-extending edge <NUM> is recessed at <NUM> so as to form seats for a suture grasped by suture passer <NUM>, as will hereinafter be discussed. Alternatively, recess <NUM> can be omitted from circumferentially-extending edge <NUM> (e.g., circumferentially-extending edge <NUM> can be formed with a substantially "flat" profile).

Hollow tube <NUM> is preferably formed out of a substantially rigid material (e.g., stainless steel) so as to maintain rigidity when passing through tissue, particularly relatively tough fibrous tissue (e.g., the labrum of the hip, the capsule of the hip joint, etc.).

In one preferred form of the present disclosure, the distal end <NUM> of hollow tube <NUM> is curved, however, it should be appreciated that hollow tube <NUM> can be formed in other configurations well known in the art (e.g., straight, compound curves, etc.).

Clamping rod <NUM> comprises a distal end <NUM> and a proximal end <NUM>. Distal end <NUM> of clamping rod <NUM> is bifurcated so as to form a first arm <NUM> and a second arm <NUM>. The distal ends of first arm <NUM> and second arm <NUM> are biased laterally so that first arm <NUM> and second arm <NUM> will extend both distally and laterally when the distal ends of first arm <NUM> and second arm <NUM> are advanced distally out of the distal end of hollow tube <NUM>, as will hereinafter be discussed in further detail. Preferably first arm <NUM> and second arm <NUM> have different degrees of lateral bias so that they will together define a funnel region therebetween when the distal ends of first arm <NUM> and second arm <NUM> are advanced distally out of the distal end of hollow tube <NUM>, as will hereinafter be discussed in further detail.

More particularly, first arm <NUM> comprises a clamping surface <NUM>, with clamping surface <NUM> extending radially from the longitudinal axis of clamping rod <NUM>. Clamping surface <NUM> may take the form of a hook, as shown in the construction illustrated in <FIG>. This hook helps trap the suture S between clamping surface <NUM> of clamping rod <NUM> and the aforementioned recesses <NUM> of circumferentially-extending edge <NUM> of hollow tube <NUM>, in the manner shown in <FIG> and <FIG>.

First arm <NUM> is outwardly biased so that when first arm <NUM> advances along cutaway <NUM>, first arm <NUM> passes radially outwardly through the cutaway so as to project at an angle of approximately <NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM> (i.e., the longitudinal axis of hollow tube <NUM> at the point adjacent to where first arm <NUM> advances through cutaway <NUM>), whereby to create one half of a funnel region <NUM> established between first arm <NUM> and second arm <NUM> when first arm <NUM> and second arm <NUM> extend out of cutaway <NUM> (<FIG>). To this end, first arm <NUM> is preferably formed out of a material consistent with this spring bias (e.g., a superelastic material such as Nitinol, etc.). In one preferred form of the disclosure, the entire clamping rod <NUM> is formed out of a superelastic material such as Nitinol.

Second arm <NUM> extends parallel to first arm <NUM> when clamping rod <NUM> is disposed within lumen <NUM> of hollow tube <NUM>, with second arm <NUM> terminating proximally of first arm <NUM>, proximal of clamping surface <NUM> (<FIG>). Second arm <NUM> comprises a recess <NUM> at its distal tip. Recess <NUM> forms a seat for suture S at the distal tip of second arm <NUM>, such that when a suture S is seated in cutaway <NUM> and second arm <NUM> thereafter extends out of cutaway <NUM>, recess <NUM> in second arm <NUM> will engage suture S and carry suture S away from cutaway <NUM>, whereby to help separate suture S from suture passer <NUM>. In one preferred form of the invention, recess <NUM> comprises a distal finger <NUM>, a proximal finger <NUM> and a groove <NUM> formed therebetween. If desired, distal finger <NUM> and proximal finger <NUM> may have substantially the same length and/or width.

Second arm <NUM> is outwardly biased so that when second arm <NUM> advances along cutaway <NUM>, second arm <NUM> passes radially outwardly through the cutaway <NUM> so as to project at an angle of approximately <NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM> (i.e., the longitudinal axis of hollow tube <NUM> at the point adjacent to where second arm <NUM> advances through cutaway <NUM>), whereby to create the aforementioned funnel region <NUM> between first arm <NUM> and second arm <NUM> when first arm <NUM> and second arm <NUM> extend out of cutaway <NUM>. To this end, second arm <NUM> is preferably formed out of a material consistent with this spring bias (e.g., a superelastic material such as Nitinol, etc.). As noted above, in one preferred form of the disclosure, the entire clamping rod <NUM> is formed out of a superelastic material such as Nitinol.

The gap between first arm <NUM> and second arm <NUM> (see gap G in <FIG>) is carefully sized, i.e., it is larger than the diameter of a suture so as to prevent a suture from being inadvertently lodged between first arm <NUM> and second arm <NUM>, which could effectively jam the components, but not so large that the transfer of suture S from first arm <NUM> to second arm <NUM> is undermined. In one preferred form of the invention, the gap between first arm <NUM> and second arm <NUM> is approximately <NUM>-<NUM> times the diameter of the suture, and preferably about <NUM> times the diameter of the suture.

In one preferred form of the present disclosure, second arm <NUM> may comprise a compound curve <NUM> (<FIG>) so as to facilitate proper disposition of second arm <NUM> when it is projected distally and laterally out of cutaway <NUM>.

If desired, the degree of the outward bias of first arm <NUM> and second arm <NUM> can be varied from the angles described above, e.g., first arm <NUM> can extend at an angle of approximately <NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM> when first arm <NUM> advances out of the distal end of hollow tube <NUM>, and second arm <NUM> can extend at an angle of approximately <NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM> when second arm <NUM> advances out of the distal end of hollow tube <NUM>. In one form of the disclosure, first arm <NUM> can extend at an angle of <NUM>-<NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM>, and second arm <NUM> can extend at an angle of <NUM>-<NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM> (but in any case at an angle which is greater than the angle of the first arm so that the two arms do not cross over one another). Still other appropriate constructions will be apparent to those skilled in the art in view of the present disclosure.

The proximal end <NUM> of clamping rod <NUM> extends through lumen <NUM> of hollow tube <NUM> and is connected to an actuator <NUM> which is movably mounted to handle <NUM>, such that movement of actuator <NUM> relative to handle <NUM> causes movement of clamping rod <NUM> relative to hollow tube <NUM>.

It will be appreciated that, on account of the foregoing construction, a piece of suture S may be clamped to the distal end of suture passer <NUM> by (i) moving clamping rod <NUM> to the position shown in <FIG> and <FIG> (e.g., by moving actuator <NUM> distally relative to handle <NUM>) so that first arm <NUM> and second arm <NUM> extend distally and laterally out of cutaway <NUM> and create the aforementioned funnel region <NUM>; (ii) positioning the suture S in funnel region <NUM> (<FIG>), preferably moving suture passer <NUM> and/or suture S as appropriate so as to settle the suture S deep within funnel region <NUM> (i.e., close to or against the pair of longitudinally-extending edges <NUM> and/or the circumferentially-extending edge <NUM>, or hooking suture S with the clamping surface <NUM> of first arm <NUM>; and (iii) moving clamping rod <NUM> proximally (e.g., by moving actuator <NUM> proximally relative to handle <NUM>) so as to cause clamping surface <NUM> of first arm <NUM> to engage suture S (<FIG> and <FIG>) and retract suture S proximally, whereby to clamp suture S against recesses <NUM> of circumferentially-extending edge <NUM> of hollow tube <NUM>, as shown in <FIG> and <FIG>. In this respect it will be appreciated that the creation of the funnel region <NUM> (established between the extended first arm <NUM> and the extended second arm <NUM>) at the mouth of cutaway <NUM> facilitates guidance of suture S into clamping position, as shown in <FIG>.

It will also be appreciated that, on account of the foregoing construction, a clamped piece of suture S may thereafter be released from suture passer <NUM> by (a) moving clamping rod <NUM> distally (<FIG>) so as to space clamping surface <NUM> of first arm <NUM> away from recesses <NUM> of circumferentially-extending edge <NUM> of hollow tube <NUM>, whereby to release suture S from its clamped condition, and with recess <NUM> of second arm <NUM> engaging suture S and driving it distally and laterally, so that suture S moves clear of cutaway <NUM> (<FIG>); and (b) causing suture S to be withdrawn from the suture passer, either by moving suture S relative to suture passer <NUM>, or by moving suture passer <NUM> relative to suture S, or by moving both suture S and suture passer <NUM> relative to one another.

It should be appreciated that, in one preferred form of the disclosure, when clamping rod <NUM> is moved proximally, both first arm <NUM> and second arm <NUM> are disposed within lumen <NUM> of hollow tube <NUM>, so that the distal end of suture passer <NUM> presents a smooth outer surface, whereby to facilitate passage of the distal end of suture passer <NUM> through tissue.

In one preferred form of the present disclosure, the novel suture passer <NUM> can be used to pass suture S from the near side of tissue to the far side of tissue (i.e., in an "antegrade" manner).

More particularly, the preliminary loading of suture S into suture passer <NUM> may be performed away from the surgical site (e.g., outside of the patient) or it may be performed adjacent to the near side of the tissue which is to be sutured (e.g., inside of the patient). This is achieved by advancing clamping rod <NUM> to its distalmost position so that first arm <NUM> and second arm <NUM> advance out of cutaway <NUM>, whereby to project the distal ends of the first and second arms out of the axis of hollow tube <NUM> and create the aforementioned funnel region <NUM>. Suture S is then guided into cutaway <NUM> using this funnel effect, either by moving suture S relative to suture passer <NUM>, or by moving suture passer <NUM> relative to suture S, or by moving both suture S and suture passer <NUM> relative to one another. If desired, the suture S may be tensioned so as to help draw it into cutaway <NUM>. Or suture S may be hooked with clamping surface <NUM> of first arm <NUM>. Clamping rod <NUM> is then retracted proximally so that clamping surface <NUM> of first arm <NUM> clamps suture S between clamping surface <NUM> of first arm <NUM> and recesses <NUM> of circumferentially-extending edge <NUM> of hollow tube <NUM>.

Suture passer <NUM> is then advanced distally so that cutaway <NUM> passes through tissue, whereby to carry suture S through the tissue. With suture S extending through the tissue, clamping rod <NUM> is advanced distally so that first arm <NUM> and second arm <NUM> extend out of cutaway <NUM>, thereby spacing clamping surface <NUM> from circumferentially-extending edge <NUM> of hollow tube <NUM>, whereby to release suture S from suture passer <NUM> and with second arm <NUM> driving suture S before it as second arm <NUM> advances distally and proximally out of cutaway <NUM>. Preferably, second arm <NUM> can flex proximally slightly at the end of the distal stroke, whereby to allow suture S to "slip off the distal end of second arm <NUM>. (see <FIG>). In this respect it will be appreciated that second arm <NUM> is flexible, but also has column strength, so that second arm <NUM> can drive the suture S distally relative to hollow tube <NUM>, but then, as the portion of second arm <NUM> projecting out of hollow tube <NUM> gets longer and longer, the second arm <NUM> eventually "flops over" under the drag of the suture S which is being pushed by second arm <NUM>, whereby to cause suture S to fall free of second arm <NUM>. Suture passer <NUM> and/or suture S are then manipulated so that suture S is clear of suture passer <NUM>. Clamping rod <NUM> is then moved proximally so as to retract first arm <NUM> and second arm <NUM> back into hollow tube <NUM>. Suture passer <NUM> may then be withdrawn back through the tissue, leaving suture S extending through the tissue.

Significantly, by providing second arm <NUM> of clamping rod <NUM> with a recess <NUM>, the suture being driven forward by second arm <NUM> of clamping rod <NUM> can be "controlled" longer during the distal stroke, i.e., the suture can be retained for a longer period of time on the distally-moving second arm <NUM> of clamping rod <NUM>. As a result, it is possible to advance longer lengths of suture through the tissue without driving the needle further through the tissue. This can be highly advantageous where longer lengths of suture may be required on the far side of the tissue, e.g., when suturing closed the capsule of the hip joint at the conclusion of an arthroscopic procedure but where the needle cannot be advanced further (e.g., if bone obstructs further passage of the needle, such as in a hip joint). At the same time, by forming second arm <NUM> out of a flexible, outwardly biased material, as the second arm <NUM> extends further and further out of hollow tube <NUM>, the drag on suture S will eventually cause second arm <NUM> to "flop over", whereby to release the suture S from second arm <NUM>.

In another preferred form of the present disclosure, the novel suture passer <NUM> can be used to draw suture S from the far side of tissue to the near side of tissue (i.e., in a "retrograde" manner).

More particularly, in this form of the invention, the suture S is loaded into suture passer <NUM> on the far side of the tissue. This is done by first passing suture passer <NUM> through the tissue so that cutaway <NUM> resides on the far side of the tissue, and then moving clamping rod <NUM> distally so that first arm <NUM> and second arm <NUM> extend distally and proximally out of cutaway <NUM>, whereby to create the aforementioned funnel region <NUM>. This funnel effect is then used to guide a free suture (disposed on the far side of the tissue) into cutaway <NUM>, either by moving suture S relative to suture passer <NUM>, or by moving suture passer <NUM> relative to suture S, or by moving both suture S and suture passer <NUM> relative to one another. If desired, the suture S may be tensioned so as to help draw it into cutaway <NUM>. Or suture S may be hooked with clamping surface <NUM> of first arm <NUM>.

Next, clamping rod <NUM> is retracted proximally so as to releasably secure suture S between clamping surface <NUM> of first arm <NUM> and recesses <NUM> of circumferentially-extending edge <NUM> of hollow tube <NUM>. Suture passer <NUM> is then retracted proximally through the tissue, carrying suture S therethrough. Suture S can then be released from suture passer <NUM> by moving clamping rod <NUM> distally, whereby to cause second arm <NUM> to drive suture S out of cutaway <NUM> and clear of suture passer <NUM>.

If desired, first arm <NUM> can be formed without an outward bias, so that only second arm <NUM> has an outward bias. In this form of the disclosure, the funnel region <NUM> is still formed between the distal ends of first arm <NUM> and second arm <NUM>, however, the funnel region <NUM> will extend at a different angle relative to the adjacent longitudinal axis of hollow tube <NUM> than when both first arm <NUM> and second arm <NUM> are outwardly biased.

If desired, and looking now at <FIG>, second arm <NUM> may be formed without the aforementioned compound curve <NUM>.

Furthermore, if desired, recess <NUM> at the distal tip of second arm <NUM> may be formed with a different geometry, e.g., so as to facilitate separation of suture S from second arm <NUM> at the end of the second arm's distal stroke. By way of example but not limitation, recess <NUM> may comprise a longer distal finger <NUM> and a shorter proximal finger <NUM>, with the groove <NUM> being formed therebetween. As a result of this construction, when a suture S is seated in cutaway <NUM> and second arm <NUM> thereafter extends out of cutaway <NUM>, recess <NUM> in second arm <NUM> will engage suture S and carry suture S away from cutaway <NUM>, and the shorter proximal finger <NUM> will thereafter facilitate separation of suture S from suture passer <NUM>. In effect, and as best seen in <FIG>, as second arm <NUM> moves further and further out of hollow tube <NUM>, the second arm <NUM> becomes progressively less supported by hollow tube <NUM> which, at the end of the second arm's distal stroke and in combination with the shorter proximal finger <NUM>, allows the suture S to fall away from second arm <NUM> in the proximal direction. In this respect it will also be appreciated that where suture S extends through tissue proximal to second arm <NUM>, friction between suture S and this tissue during distal movement of second arm <NUM> imposes a proximally-directed force on suture S, which (i) helps cause second arm <NUM> to bend proximally at the end of its distal stroke, thereby directing groove <NUM> more proximally, and (ii) helps suture S to pull off second arm <NUM>. If desired, second arm <NUM> can be formed with proximal finger <NUM> omitted, so that second arm <NUM> comprises only the distal finger <NUM>.

Additionally, if desired, and looking now at <FIG> and <FIG>, recess <NUM> at the distal end of second arm <NUM> may be replaced by a relatively short spike <NUM>. In this form of the disclosure, when a suture S is seated in cutaway <NUM> and second arm <NUM> thereafter extends out of cutaway <NUM>, spike <NUM> at the distal end of second arm <NUM> piercingly engages suture S and helps hold suture S on the distal end of second arm <NUM> as second arm <NUM> extends out of cutaway <NUM>, whereafter the relatively short spike <NUM> allows suture S to separate from suture passer <NUM>. More particularly, it will be appreciated that as second arm <NUM> moves further and further out of hollow tube <NUM>, the second arm <NUM> becomes progressively less supported by hollow tube <NUM> which, in combination with the relatively short length of spike <NUM>, allows the suture S to fall away from second arm <NUM> in the proximal direction. In this respect it will also be appreciated that where suture S extends through tissue proximal to second arm <NUM>, friction between suture S and this tissue during distal movement of second arm <NUM> imposes a proximally-directed force on suture S, which (i) helps cause second arm <NUM> to bend proximally at the end of its distal stroke, thereby directing spike <NUM> more proximally, and (ii) helps suture S to pull off second arm <NUM>.

Looking next at <FIG>, there is shown a construction wherein first arm <NUM> and second arm <NUM> both extend at smaller angles (than those previously disclosed) relative to the adjacent longitudinal axis of hollow tube <NUM>. More particularly, in this form of the disclosure, first arm <NUM> extends substantially parallel to the adjacent longitudinal axis of hollow tube <NUM>, and second arm <NUM> extends at an angle of approximately <NUM> degrees relative to the adjacent longitudinal axis of hollow tube <NUM>. It has been found that by configuring second arm <NUM> so that it extends at a smaller angle (than those previously disclosed) relative to the adjacent longitudinal axis of hollow tube <NUM>, the suture is more easily released from the tool after the tool has been used to pass suture in an antegrade fashion through the tissue.

In one preferred form of the disclosure, second arm <NUM> comprises a plurality of bends (e.g., two bends 281A and 281B) which act in an "additive" fashion so as to together provide an increased opening for funnel region <NUM>.

In addition, in this form of the disclosure, second arm <NUM> is configured so that it extends laterally (of hollow tube <NUM>) "sooner" (i.e., when clamping rod <NUM> is at a more proximal position than previously disclosed) so as to open funnel region <NUM> closer to the distal end of hollow tube <NUM>. This is a consequence of locating bend 281A closer to the distal end of second arm <NUM>. As a result, the tool can be used to retrieve suture without having to fully extend first arm <NUM> and second arm <NUM>, which can sometimes be difficult to do in constrained spaces.

<FIG> show first arm <NUM> and second arm <NUM> in a partially-extended position (i.e., in a position where suture can be adequately retrieved), while <FIG> show first arm <NUM> and second arm <NUM> in a fully-extended position (i.e., in a position where suture can be fully advanced when being passed through tissue). <FIG> shows clamping rod <NUM> prior to assembly into suture passer <NUM>.

Significantly, by alternating the aforementioned antegrade suture passing procedure with the aforementioned retrograde suture passing procedure, with the needle "plunges" being laterally spaced from one another in the tissue, a mattress stitch may be placed in the tissue.

If desired, the novel suture passer <NUM> may also be used to pass suture S around a side edge of the tissue, rather than passing the suture S through the tissue. By way of example but not limitation, if the hollow tube <NUM> is passed around the side edge of the tissue (rather than through it), the suture passer could then be used to retrieve the suture on the far side of the tissue and draw it back around the side edge of the tissue so that the suture is brought to the near side of the tissue.

In the preceding disclosure, there are shown various novel suture passers (e.g., novel suture passer <NUM>, novel suture passer <NUM>, novel suture passer <NUM>, etc.) which can be used to pass suture from one side of tissue to another side of tissue.

By way of example but not limitation, the novel suture passers can be used to pass suture from the near side of tissue to the far side of tissue (see, for example, <FIG>, where novel suture passer <NUM> is used to pass suture from the near side of tissue T to the far side of tissue T, in an "antegrade" manner). It will be appreciated that the suture extends alongside the exterior of the suture passer during such antegrade passing of the suture through the tissue.

By way of further example but not limitation, the novel suture passers can be used to draw suture from the far side of tissue to the near side of tissue (see, for example, <FIG>, where novel suture passer <NUM> is used to draw suture S from the far side of tissue T to the near side of tissue T, in a "retrograde" manner).

In some circumstances, it may be desirable to use the novel suture passers to pass suture from the near side of tissue to the far side of tissue at a first location, deposit a loop of suture on the far side of the tissue at that first location, withdraw the suture passer back through the tissue at that first location, move the suture passer laterally to a second location, advance the suture passer from the near side of the tissue to the far side of the tissue at that second location, pick up the loop of suture left on the far side of the tissue with the suture passer, and then use the suture passer to draw that loop of suture from the far side of the tissue to the near side of the tissue at that second location. In this way, a "stitch" of suture can be set through the tissue, with the suture advancing through the tissue at the first location and returning from the tissue at the second location.

However, it has been found that, in some circumstances, the tissue can form a tight fit about the suture passer. As a result, inasmuch as the suture extends alongside the exterior of the suture passer during an antegrade pass (see above), when the suture passer has dropped off the loop of suture on the far side of the tissue and the suture passer is thereafter withdrawn back through the tissue, the suture passer may unintentionally pull the suture back through the tissue with the withdrawing suture passer, which can result in, at best, a smaller loop of suture being left on the far side of the tissue (thereby making later retrieval of suture S with the suture passer more difficult) or, at worst, pulling the loop of suture completely back through the tissue with the returning suture passer (thereby making later retrieval of the suture S with the suture passer impossible).

To counteract this effect, the first and second arms of the clamping rod may be projected further out of the distal end of the hollow tube of the suture passer, so that a larger loop of suture is deposited on the far side of the tissue. Then, even if some of the suture should be pulled back through the tissue with the returning suture passer, it is likely that an adequate loop of suture will still remain on the far side of the tissue.

However, in some circumstances, there may be inadequate space on the far side of the tissue to accommodate longer first and second arms (and hence a longer projection of the first and second arms beyond the distal end of the hollow tube). By way of example but not limitation, there may be inadequate space on the far side of the tissue where the tissue is located in close proximity to an underlying structure (e.g., bone, delicate vascular and/or neurological tissue, etc.).

With this in mind, and looking now at <FIG>, there is now provided a further novel suture passer 205A which is generally similar to the novel suture passer <NUM> discussed above, except that hollow tube 210A and clamping rod 215A are sized so that clamping rod 215A can draw suture S within the interior of hollow tube 210A, without causing clamping surface 285A of clamping rod 215A to trap suture S against the circumferentially-extending edge 255A of hollow tube 210A (as is the case with suture passer <NUM> described above and shown in <FIG>). Thus, in this form of the invention, "clamping" surface 285A functions more like a "hooking" surface than a "clamping" surface, and clamping rod 215A functions more like a "hooking" rod than a "clamping" rod. For the purposes of the following discussion, surface 285A will be referred to herein as a hooking surface, and rod 215A will be referred to herein as a hooking rod. The suture that is drawn within the interior of hollow tube 210A is payed back out again when hooking rod 215A moves distally within hollow tube 210A and extends out the distal end of hollow tube 210A. In one preferred form of the invention, the suture that is drawn into the interior of hollow tube 210A is pushed back out of hollow tube 210A by (i) pushing by hooking surface 285A of first arm 275A when hooking rod 215A moves distally within hollow tube 210A and extends out the distal end of hollow tube 210A (inasmuch as the suture S releasably adheres to hooking surface 285A by a creasing or crimping action during suture capture), as hereinafter discussed below, and/or (ii) pushing by the distal end of second arm 280A when hooking rod 215A moves distally within hollow tube 210A and extends out the distal end of hollow tube 210A, as hereinafter discussed below.

As a result of this construction, suture length can effectively be "stored" within the interior of hollow tube 210A during antegrade passage of suture passer 205A through tissue T, whereby to deploy an enlarged loop of suture S on the far side of tissue T when hooking rod 215A is advanced out the distal end of hollow tube 210A. Then, even if some of the suture loop should be pulled back through the tissue with the returning suture passer, it is likely that an adequate loop of suture will still remain on the far side of the tissue, thus significantly improving the ease of subsequent suture retrieval on the far side of the tissue. This is especially true if, for example, the location at which the suture passer 205A must retrieve the suture S is located a substantial distance away from the location at which suture S was passed through the tissue. For example, if there is a gap between opposing sides of a cut tissue which is being sutured closed, when the suture passer 205A deploys an enlarged loop of suture S on the far side of tissue T, it will be easier to thereafter retrieve the loop of suture S when suture passer 205A pierces the opposite side of the cut to retrieve the suture S. It should be appreciated that the greater the distance suture S is drawn into hollow tube 210A, the larger the size of the suture loop that will be payed out on the far side of the tissue. For example, if the suture S is drawn into hollow tube 210A a distance of <NUM>,<NUM> (<NUM> inch), then a suture loop comprising approximately <NUM>,<NUM> (<NUM> inches) of suture S will be delivered out the end of hollow tube 210A.

Thus, with the suture passer 205A shown in <FIG>, a larger loop of suture S can be deployed on the far side of the tissue without requiring the first and second arms 275A, 285A of hooking rod 215A to extend further out of the distal end of hollow tube 210A.

<FIG> show suture passer 205A with its hooking rod 215A disposed within the interior of hollow tube 210A.

<FIG> show suture passer 205A with the distal end of its hooking rod 215A projecting out the distal end of hollow tube 210A. Note that in <FIG>, first arm 275A of hooking rod 215A is shown as extending at an angle to the local longitudinal axis of the distal end of hollow tube 210A when first arm 275A projects out of the distal end of hollow tube 210A.

More preferably, and looking now at <FIG>, first arm 275A of hooking rod 215A is configured to extend parallel to the local longitudinal axis of the distal end of hollow tube 210A when first arm 275A projects out of the distal end of hollow tube 210A.

<FIG> show suture passer 205A capturing a suture S by means of the interaction of first arm 275A and second arm 280A of hooking rod 215A, and drawing a portion of that suture S within the interior of hollow tube 210A by means of hooking surface 285A of first arm 275A of hooking rod 215A.

<FIG> show suture passer 205A releasing a suture which had been previously captured by suture passer 205A and which had a portion of that suture "stored" within the interior of hollow tube 210A, e.g., by using the distal end of second arm 280A of hooking rod 215A to push the "stored" suture back out of hollow tube 210A.

As noted above, with this form of the invention, hooking surface 285A of first arm 275A functions like a hooking surface (i.e., to draw suture S into the interior of hollow tube 210A) rather than as a clamping surface to clamp suture S against circumferentially-extending edge 255A of hollow tube 210A. Hooking surface 285A of first arm 275A may also help push suture S distally as hooking rod 215A advances distally within and out of hollow tube 210A, inasmuch as suture S releasably adheres to hooking surface 285A by a creasing or crimping action during suture capture, as will hereinafter be discussed. It should be appreciated that a sufficient gap is formed between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A such that suture S can slide without binding as hooking rod 215A is withdrawn into, and advanced out of, hollow tube 210A, such that suture S can be drawn into hollow tube 210A and be pushed out of hollow tube 210A. It should also be appreciated that, inasmuch as there can be appreciable tension on suture S as suture S is passed and retrieved through tissue, in order for suture S to be held securely onto hooking surface 285A of hooking rod 215A once suture S is drawn into hollow tube 210A, the gap between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A cannot be so great as to allow suture S to prematurely slip off the hooking surface 285A of hooking rod 215A (i.e., to flip up and over the edge of the hook, then pass distally between the distal end of first arm 275A and hollow tube 210A). Thus, there is an optimally sized gap between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A which keeps suture S secure on hooking surface 285A of first arm 275A yet allows suture S to slide when hooking rod 215A is moved within hollow tube 210A.

By way of example but not limitation, where suture S is a size #<NUM> orthopedic braided suture with an external diameter of <NUM>,<NUM> (<NUM> inches), the distal end of first arm 275A may have an outer diameter of approximately <NUM>,<NUM> (<NUM> inches) and hollow tube 210A may have an inner diameter of <NUM>,<NUM> (<NUM> inches). As such, the inner diameter of hollow tube 210A is approximately <NUM>% larger than the diameter of suture S. It has been discovered that best results are achieved where the inner diameter of outer tube 210A is preferably between approximately <NUM>% to <NUM>% larger than the diameter of suture S, and more preferably approximately <NUM>% to <NUM>% larger than the diameter of suture S. Also, as such, there is a <NUM>,<NUM> (<NUM> inch) gap (between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A) for suture S to pass between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A. A size #<NUM> orthopedic braided suture has a diameter of approximately <NUM>,<NUM> (<NUM> inches); therefore, it is compressed to approximately <NUM>,<NUM> (<NUM> inches) (i.e., the size of the gap between the outer surface of the distal end of first arm 275A and the inner surface of hollow tube 210A), or to approximately <NUM>% of its original diameter (see <FIG>) when the suture is drawn into hollow tube 210A by hooking rod 215A. It has been found that if the outer diameter of the distal end of first arm 275A is <NUM> inches (i.e., the suture compresses to <NUM>% of its original diameter), suture S may bind to hollow tube 210A as hooking rod 215A moves within hollow tube 210A. Preferably, suture S is compressed to greater than approximately <NUM>% of its original diameter when suture S is disposed between the outer surface of the distal end of first arm 275A and the inner diameter of hollow tube 210A.

It should be appreciated that the distance that hooking surface 285A is recessed (i.e., distance "L" in <FIG>) within the distal end of first arm 275A also affects the holding force of suture S when suture S is held within hollow tube 210A. Increasing distance "L" increases the holding force applied to suture S, whereas decreasing distance "L" decreases the holding force applied to suture S. By way of example but not limitation, where the outer diameter of the distal end of first arm 275A is <NUM>,<NUM> (<NUM> inches) and the inner diameter of hollow tube 210A is <NUM>,<NUM> (<NUM> inches) and hooking surface 285A is recessed <NUM>,<NUM> (<NUM> inches), when suture S has been drawn into the interior of hollow rod 210A by hooking rod 215A and tension is thereafter applied to one limb of suture S in an approximately longitudinal direction, a #<NUM> orthopedic suture will be held with approximately <NUM>-<NUM> lbs. of force (<NUM>,<NUM> N - <NUM>,<NUM> N) before releasing from hooking rod 215A.

It should also be appreciated that the shape and size of the hooking surface 285A of first arm 275A can affect the ability of suture S to exit the recess of the hook of first arm 275A. For example, when first arm 275A is fully extended out of hollow tube 210A and second arm 280A is biased away from first arm 275A, a hooking surface 285A having a smaller radius R (<FIG>) may tend to bind the suture and prevent it from exiting the recess of first arm 285A, and a hooking surface 285A of a larger radius R enables the suture to more freely exit the recess of first arm 285A. Conversely, a hooking surface 285A having a radius R of a large size may not sufficiently bind suture S. In a preferred embodiment, hooking surface 285A has a radius R of <NUM>,<NUM> (<NUM> inches), or a radius R approximately equal to one half the diameter of suture S when suture S is a #<NUM> orthopedic suture. Hooking surface 285A of first arm 275A may function to help push suture S distally as hooking rod 215A advances distally within hollow tube 210A. More particularly, suture passer 205A may rely on a degree of binding between hooking surface 285A of hooking rod 215A and suture S in order to carry suture S distally. In this respect it will be appreciated that suture S may "crease" or "crimp" slightly around edges of hooking surface 285A of first arm 275A as suture S is drawn into hollow tube 210A due to tension on suture S. The "crease" or "crimp" of the suture will create a slight adhesion of the suture S to hooking surface 285A of first arm 275A, so that suture S will be carried distally with first arm 275A when hooking rod 215A moves distally within and out of hollow tube 210A.

It should also be appreciated that with this form of the invention, second arm 280A may also "push" suture S distally as hooking rod 215A advances distally within and out of hollow tube 210A.

As described above, suture S will preferably bind to hooking surface 285A of first arm 275A when suture S is drawn into hollow tube 210A. However, in some circumstances, upon distal movement of hooking rod 215A within hollow tube 210A (i.e., when suture S is payed back out of suture passer 205A) suture S may dislodge from hooking surface 285A of first arm 275A. In this event, the distal end of second arm 280A engages suture S and pushes it distally. In other words, if suture S dislodges from hooking surface 285A of first arm 275A, the distal end of second arm 280A then "pushes" suture S distally as hooking rod 215A advances distally within hollow tube 210A and extends out the distal end of hollow tube 210A (up until the point when second arm 280A biases laterally away from first arm 275A). The thickness TH of second arm 280A (<FIG>) must be sufficiently large so as not to pierce suture S during such distal movement of hooking rod 215A. To this end, it has been found that thickness TH of second arm 280A should be minimally at least as large as <NUM>% of the diameter of suture S, and more preferably approximately equal to the diameter of suture S.

Second arm 280A may also function to help retrieve suture S, either at the initial pick-up of the suture S or after the suture has been deployed through tissue. By way of example but not limitation, once suture passer 205A has passed suture S through tissue, suture passer 205A can be used to therafter retrieve suture S, either after suture passer 205A has been passed through tissue at another location or directly (e.g., via access from a different direction). Inasmuch as second arm 280A is biased away from first arm 275A when the distal end of hooking rod 215A extends out the distal end of hollow tube 210A, suture S can be positioned in the gap between first arm 275A and second arm 280A (<FIG>). When hooking rod 215A is thereafter moved proximally, second arm 280A will close toward first arm 275A and capture suture S in the space SP between first arm 275A and second arm 280A (<FIG>, <FIG> and <FIG>). Upon further proximal movement of hooking rod 215A, as suture S engages circumferentially-extending edge 255A of hollow tube 210A, suture S may be held for pick-up by hooking surface 285A of first arm 275A (<FIG> and <FIG>) as hooking surface 285A of first arm 275A passes by circumferentially-extending edge 255A of hollow tube 210A. Upon still further proximal movement of clamping rod <NUM>, suture S is drawn into hollow tube 210A (<FIG>).

The gap G (<FIG>) between the proximal tip of the hook of first arm 275A and the distal end of second arm 280A must be large enough that second arm 280A does not bind to the hook of first arm 275A as the distal end of hooking rod 215A passes through the curvature of hollow tube 210A. In this respect it should be appreciated that the distal end of second arm 280A will move towards the hook of first arm 275A as hooking rod 215A passes through a curvature (in the direction of second arm 280A) in hollow tube 210A. In other words, as hooking rod 215A passes through a curvature (in the direction of second arm 280A) in hollow tube 210A, the gap G between the hook tip of first arm 275A and the distal end of second arm 280A will be reduced, since both the proximal tip of the hook of first arm 275A and the distal end of second arm 280A are offset from the central axis of hooking rod 215A. Thus, the gap must be large enough to prevent binding between first arm 275A and second arm 280A as hooking rod 215A traverses a curve in hollow tube 210A. At the same time, the gap G between the hook tip of first arm 275A and the distal end of second arm <NUM> must also not be so great so as to insufficiently retain suture S as suture S is being pushed distally in hollow tube <NUM> (i.e., if the gap G is too large, the suture may shift relative to clamping rod <NUM> and compromise subsequent distal movement of the suture during suture release). Gap G must also not be so great so as to prevent capture of suture S between first arm 275A and second arm 280A. As described above, during retrieval of suture S, suture passer 205A may be manipulated so as to place suture S between first arm 275A and second arm 280A (<FIG>). Once suture S is in position, hooking rod 215A is retracted proximally. As hooking rod 215A is drawn into hollow tube 210A, second arm 280A is forced to close down towards first arm 275A, trapping suture S between first arm 275A and second arm 280A (<FIG>). If gap G is too large, second arm 280A may miss suture S (such as, for example, if suture S is located distal to the distal end of second arm 280A) and hence not capture suture S. Gap G is preferably approximately <NUM>,<NUM> (<NUM> inches) in the longitudinal direction, or approximately <NUM>% as large as the diameter of the hooking rod 215A. Gap G may be approximately <NUM>% to <NUM>% of the diameter of the hooking rod 215A depending on the curvature of the hollow tube 210A through which the hooking rod 215A must pass.

The space SP between first arm 275A and second arm 280A is sized to releasably capture suture S between first arm 275A and second arm 280A when hooking rod 215A is retracted into hollow tube 210A (<FIG> and <FIG>), but space SP is also sufficiently large so as to allow suture S to slide distally along first arm 275A and second arm 280A (<FIG> and <FIG>) when suture S engages circumferentially-extending edges 255A of hollow tube 210A. In other words, if suture S is not first captured directly in the hooking surface 285A of first arm 275A, when hooking rod 215A is moved proximally, at the point where second arm 280A closes, if suture S is trapped between first arm 275A and second arm 280A, circumferentially-extending edge 255A of hollow tube 210A stops suture S from moving proximally even as hooking rod 215A continues to move proximally. Once hooking surface 285A reaches circumferentially-extending edge 255A of hollow tube 210A, the space SP between first arm 275A and second arm 280A allows suture S to "slip" relative to hooking rod 215A while suture S remains against circumferentially-extending edge 255A of hollow tube 210A, until hooking surface 285A of first arm 275A engages suture S and draws suture S into hollow tube 210A (<FIG>). It has also been found that space SP is preferably at least as large as <NUM>% of the diameter of suture S, and more preferably approximately <NUM>-<NUM>% the diameter of suture S, so as to allow the aforementioned releasable gripping of suture S.

It should be noted that with the aforementioned suture passer <NUM>, the distal end of hollow tube <NUM> preferably comprises cutaway <NUM>, longitudinally-extending edges <NUM> and circumferentially-extending edge <NUM> as described above and shown in <FIG>. Although with suture paser 205A suture S is no longer clamped between hooking surface 285A and cutaway 245A, it has been found that providing cutaway 245A is still beneficial in that it allows suture S to be drawn into hollow tube 210A without being dislodged from hooking surface 285A (i.e., when hooking rod 285A pulls suture S in the proximal direction). It has also been found that if the distal end of hollow tube 210A comprises a bevel cut (i.e., no cutaway 245A), suture S can be prone to dislodge from hooking surface 285A and/or the hook of first arm 275A can catch on the end of hollow tube 210A as the distal end of first arm 275A passes by the bevel cut of hollow tube 210A in a proximal direction.

In a preferred embodiment, the distal end of hooking rod 215A has a circular cross-section (<FIG>). In another embodiment, the distal end of first arm 275A has a smaller width as compared to its height (<FIG>). In this latter embodiment, the gap between the top and bottom surfaces of the distal end of first arm 275A and the inner diameter of hollow tube 210A is reduced, so as to further stabilize the distal end of first arm 275A within hollow tube 210A, thus reducing any movement of first arm 285A within hollow tube 210A and hence increasing the holding force of suture S. And in this embodiment, the gap between the sides of the distal end of first arm 275A may be increased so as to enable suture S to slide more freely within hollow tube 210A. In other words, the embodiment shown in <FIG> may maintain or increase the holding force on suture S (as compared to the embodiment shown in <FIG>), while improving the ability for suture S to slide freely within hollow tube 210A.

<FIG> illustrate the suture passer 205A delivering a suture loop to the far side of tissue T. In <FIG>, suture is loaded onto the suture passer 205A by placing the suture between first arm 275A and second arm 280A; in a preferred embodiment, suture S is placed against hooking surface 285A. In <FIG>, hooking rod 215A has been retracted proximally, carrying the suture S into the hollow tube 210A. At this point, suture passer 205A and suture S are ready to be passed through the tissue. Thereafter, in <FIG>, after suture passer 205A and suture S have been passed through the tissue, the hooking rod 215A is advanced distally and extended out of the hollow tube 210A, delivering a large suture loop (i.e., on the far side of the tissue T). To remove the suture passer from the far side of the tissue T, the suture passer 205A is moved free of the loop of suture S, hooking rod 215A is retracted back into hollow tube 210A, then the suture passer 205A is pulled back out of the tissue T (not shown).

In one form of the invention, handle 235A of suture passer 205A (<FIG>) comprises means for enabling the user to determine how far actuator 320A has travelled. By way of example but not limitation, in one preferred form of the invention, handle 235A comprises one or more detents such that when the actuator 320A is repositioned, the user feels one or more tactile clicks, and/or hears one or more audible clicking sounds, during movement of the actuator 320A between its most distal and proximal positions on handle 235A.

In another form of the present invention, hooking rod 215A comprises only a first arm 275A (<FIG>). In this embodiment, a pushing surface 286A may serve to engage and help push the suture S when suture S is being moved distally within hollow tube 210A. Pushing surface 286A is spaced from hook of first arm 275A by a gap similar to gap G as described above. In all other respects, first arm 275A and hollow tube 210A operate in the same manner as described above.

In yet another form of the present invention, first arm 275A of hooking rod 215A has a tissue-penetrating distal end (<FIG> and <FIG>). In this embodiment, hollow tube 210A does not have a tissue-penetrating distal end. In all other respects, the invention as described above and shown in <FIG> apply (i.e., the construction and operation of first arm 275A, second arm 280A, hollow tube 210A, etc.).

Claim 1:
A suture passer (<NUM>, <NUM>, 205A) with a suture (S), the suture passer comprising:
a hollow tube (<NUM>, <NUM>, 210A), said hollow tube (<NUM>, <NUM>, 210A) comprising a distal end (<NUM>, <NUM>), a proximal end (<NUM>, <NUM>), and a lumen (<NUM>, <NUM>) extending from said distal end (<NUM>, <NUM>) to said proximal end (<NUM>, <NUM>); and
a suture manipulation rod (<NUM>, <NUM>, 215A) slidably received in said lumen (<NUM>, <NUM>) of said hollow tube (<NUM>, <NUM>, 210A) and selectively projectable out said distal end (<NUM>, <NUM>) of said hollow tube (<NUM>, <NUM>, 210A), said suture manipulation rod (<NUM>, <NUM>, 215A) comprising a distal end (<NUM>, <NUM>) and a proximal end (<NUM>, <NUM>), wherein said distal end (<NUM>, <NUM>) of said suture manipulation rod (<NUM>, <NUM>, 215A) comprises a hook (<NUM>, <NUM>, 285A) comprising a proximally oriented hooking surface (285A) and a return (<NUM>) extending proximally of said hooking surface;
wherein said hollow tube (<NUM>, <NUM>, 210A) and said suture manipulation rod (<NUM>, <NUM>, 215A) are sized so that said suture manipulation rod (<NUM>, <NUM>, 215A) may capture the suture (S) disposed adjacent to said distal end (<NUM>, <NUM>) of said hollow tube (<NUM>, <NUM>, 210A) and draw the suture (S) into a gap between an inner surface of said hollow tube (<NUM>, <NUM>, 210A) and the distal end of the suture manipulation rod, wherein the gap is sized so that the suture is compressed when the suture is disposed in the gap between the inner surface of said hollow tube (<NUM>, <NUM>, 210A) and the distal end of the suture manipulation rod, and said hook (<NUM>, <NUM>, 285A) is configured to releasably bind the suture (S) to said suture manipulation rod (<NUM>, <NUM>, 215A), and characterized in that after the suture (S) has been drawn into said gap, distal movement of said suture manipulation rod (<NUM>, <NUM>, 215A) causes the suture (S) to be carried distally with the hooking surface (285A) to be expelled from said hollow tube (<NUM>, <NUM>, 210A).