Patent ID: 12201293

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

The Novel Suture Passer

Looking first atFIGS.1-11, there is shown a novel suture passer5formed in accordance with the present invention. Suture passer5generally comprises a hollow tube10and a clamping rod15slidably disposed within the lumen of hollow tube10, as will hereinafter be discussed in further detail.

More particularly, hollow tube10comprises a distal end20preferably terminating in a sharp point22, and a proximal end25preferably terminating in a handle23, with a lumen30extending therebetween. It will be appreciated that the pointed hollow tube10essentially comprises a hollow needle adapted to pierce tissue.

Hollow tube10further comprises a window35which extends radially into the hollow tube and communicates with lumen30. Window35is sized so as to selectively receive a suture S therein, as will hereinafter be discussed in further detail. Window35preferably comprises an inclined distal surface40and an inclined proximal surface45. Preferably, distal surface40and proximal surface45are inclined in the same direction, and preferably both surfaces are inclined distally (e.g., in the manner shown inFIGS.1-11). The forward incline of inclined distal surface40allows suture to more easily pass into and out of window35. The forward incline of inclined proximal surface45provides an undercut which helps to trap the suture S between the clamping surface47of clamping rod15and the inclined proximal surface45of window35, as will hereinafter be discussed in further detail.

Hollow tube10is 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 invention, the distal end20of hollow tube10is curved, however, it should be appreciated that hollow tube10can be formed in other configurations well known in the art (e.g., straight, etc.).

Clamping rod15comprises a distal end50(FIG.9) and a proximal end55(FIG.9). Distal end50of clamping rod15is bifurcated so as to form a first arm60and a second arm65.

First arm60comprises the aforementioned clamping surface47, with clamping surface47extending radially from the longitudinal axis of clamping rod15. Clamping surface47may take the form of a hook, as shown inFIGS.1-11. This hook helps trap the suture S between clamping surface47of clamping rod15and inclined proximal surface45of window35, in the manner shown inFIGS.10and11.

Second arm65extends parallel to first arm60when clamping rod15is disposed within lumen30of hollow tube10, with second arm65terminating proximally of first arm60, shy of clamping surface47.

Second arm65is outwardly biased so that when second arm65advances past window35, second arm65passes radially outwardly through window35so as to project at an angle of approximately 10-120 degrees relative to the longitudinal axis of first arm60(FIG.6), and more preferably at an angle of approximately 30-90 degrees to the longitudinal axis of first arm60, whereby to create a funnel region75between hollow tube10and second arm65when second arm65extends out window35. To this end, second arm65is 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 invention, the entire clamping rod15is formed out of a superelastic material such as Nitinol.

The proximal end55of clamping rod15extends through lumen30of hollow tube10and is connected to an actuator72(FIG.1) which is movably mounted to handle23, such that movement of actuator72relative to handle23will cause movement of clamping rod15relative to hollow tube10.

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 passer5by (i) moving clamping rod15to the position shown inFIGS.5and6(e.g., by moving actuator72distally relative to handle23) so that clamping surface47of first arm60is distal to window35, and so that second arm65extends out of window35; (ii) positioning the suture S in window35(FIGS.7-9); and (iii) moving clamping rod15proximally (e.g., by moving actuator72proximally relative to handle23) so as to cause clamping surface47of first arm60to clamp suture S against proximal surface45of window35, as shown inFIGS.10and11. In this respect it will be appreciated that the creation of the funnel region75(established between hollow tube10and the extended second arm65) at the mouth of window35facilitates guidance of suture S into window35, as shown inFIGS.7-9.

It will also be appreciated that, on account of the foregoing construction, a clamped piece of suture may thereafter be released from suture passer5by (a) moving clamping rod15distally (FIGS.8and9) so as to space clamping surface47of first arm60away from proximal surface45of window35; and (b) causing suture S to be withdrawn from window35(FIG.7), either by moving suture S relative to suture passer5or by moving suture passer5relative to suture S or by moving both suture S and suture passer5relative to one another.

It should be appreciated that, in one preferred form of the invention, when clamping rod15is moved proximally, both first arm60and second arm65are disposed within lumen30of hollow tube10, so that the distal end of suture passer5presents a smooth outer surface, whereby to facilitate passage of the distal end of suture passer5through tissue.

Using the Novel Suture Passer to Pass Suture from the Near Side of Tissue to the Far Side of Tissue

In one preferred form of the present invention, and looking now atFIGS.12-18, the novel suture passer5can 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 passer5may 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 inFIG.12, clamping rod15is advanced to its most distal position so that second arm65advances out of window35, whereby to project out of the axis of hollow tube10and create the aforementioned funnel region75. Suture S is then guided into window35using this funnel effect, as seen inFIG.13, either by moving suture S relative to suture passer5or by moving suture passer5relative to suture S or by moving both suture S and suture passer5relative to one another. Clamping rod15is then retracted proximally so that clamping surface47clamps suture S between clamping surface47of first arm60and proximal surface45of window35. SeeFIG.14.

Suture passer5is then advanced distally so that window35passes through tissue T, whereby to carry suture S through the tissue (FIG.15). With suture S extending through tissue T, and looking now atFIG.16, clamping rod15is advanced distally so that clamping surface47is disposed distal to window35, thereby releasing suture S from suture passer5. Suture passer5and/or suture S are then manipulated so that suture S is clear of window35(FIG.17). Clamping rod15is then moved proximally so as to retract first arm60and second arm65back into hollow tube10. Suture passer5may then be withdrawn back through tissue T, leaving suture S extending through tissue T, as shown inFIG.18.

Using the Novel Suture Passer to Draw Suture from the Far Side of Tissue to the Near Side of Tissue

In another preferred form of the present invention, and looking now atFIGS.19-25, the novel suture passer5can 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 passer5on the far side of the tissue T. This is done by first passing suture passer5through tissue T so that window35resides on the far side of the tissue, and then moving clamping rod15distally so that second arm65extends out of window35, substantially perpendicularly to hollow tube10, whereby to create the aforementioned funnel region75(FIGS.19and20). This funnel effect is then used to guide free suture (disposed on the far side of tissue T) into window35(seeFIG.21), either by moving suture S relative to suture passer5or by moving suture passer5relative to suture S or by moving both suture S and suture passer5relative to one another. If desired, the suture S may be tensioned so as to help draw it into the window35.

Next, clamping rod15is retracted proximally so as to releasably secure suture S between clamping surface47and proximal surface45of window35(FIG.22). Hollow tube10is then retracted proximally through tissue T, carrying suture S therethrough (FIG.23). If desired, suture S can then be released from suture passer5by moving clamping rod15distally (FIGS.24and25).

Significantly, by alternating the aforementioned antegrade suture passing procedure (FIGS.12-18) with the aforementioned retrograde suture passing procedure (FIGS.19-25), with the needle “plunges” being laterally spaced from one another in the tissue (FIG.19), a mattress stitch may be placed in the tissue (FIG.25).

If desired, the novel suture passer5may 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 tube10is 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 passer5has 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 passer5from the portal through which the suture passer5is 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.

Alternative Embodiments

As noted above, clamping surface47of clamping rod15may take the form of a hook, as shown inFIGS.1-11. This hook may have various degrees of depth and return, as seen inFIGS.26-28. Alternatively, clamping surface47may be substantially flat, as shown inFIG.29.

In addition, and looking now atFIGS.29A and29B, if desired, second arm65of suture passer5may include a plurality of suture-engaging projections76on its distal side. Suture-engaging projections76allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm65, whereby to facilitate manipulation of suture S via engagement with second arm65. Thus, for example, with the construction shown inFIGS.29A and29B, if the user needs to move the suture S about a surgical site, the user can “grip” the suture S with the suture-engaging projections76of second arm65and “drag” the suture S into a desired position. In another example, the suture-engaging projections76of second arm65can assist in dragging suture S into window35. More particularly, as the clamping rod15is moved proximally in hollow tube10, the second arm65retracts into the lumen of the hollow tube10. As it does so, if the suture S is in contact with the suture-engaging projections76of second arm65, suture S will be drawn into window35. Once in window35, the suture S is then clamped between clamping surface47of clamping rod15and inclined proximal surface45of window35as described above.

Alternatively, and looking now atFIGS.29C and29D, second arm65of suture passer5may include a plurality of suture-engaging projections76on its proximal side. Again, suture-engaging projections76allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm65, whereby to facilitate manipulation of suture S via engagement with second arm65.

If desired, suture-engaging projections76may also be provided on both the distal and proximal sides of second arm65, and/or on one or both of the lateral sides of second arm65.

It will be appreciated that suture-engaging projections76essentially constitute a friction-enhancing surface on second arm65so as to allow second arm65to 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 arm65may be formed with a variety of geometries, e.g., barbs, fingers, ribs, threads or other surface texturing which increases the frictional aspects of second arm65at 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 surface47of clamping rod15and inclined proximal surface45of window35. In this form of the invention, suture S is slidably captured between the two surfaces (i.e., clamping surface47and proximal surface45), in the manner shown inFIGS.30and31. In this form of the invention, clamping rod15may be limited in its proximal travel (e.g., by means of interaction between actuator72and handle23) 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 inFIGS.32and33. This spearing of the suture can enhance clamping of the suture S to the suture passer5. By way of example but not limitation, first arm60of clamping rod15may include a pointed return77, with pointed return77being configured and located such that it will spear suture S when clamping rod15is moved proximally.

It should be appreciated that the lengths of the first and second arms60,65of clamping rod15can vary from the construction shown inFIGS.1-11. By way of example but not limitation, in one preferred form of the invention, the distance between the distal tip of second arm65and clamping surface47is approximately the length of window35, as shown inFIG.34. In another preferred form of the invention, only a nominal gap is provided between the distal tip of second arm65and clamping surface47(FIG.35). This construction can provide for improved capturing of suture S to suture passer5.

In another form of the present invention, suction may be applied to lumen30of hollow tube10proximal to window35. This suction will draw fluid into window35, and the fluid entering window35will assist suture S in seating itself into window35as the suture S approaches window35.

In another form of the present invention, fluid is delivered down lumen30of hollow tube10so as to assist ejection of suture S from window35once the clamping rod15has released suture S.

In yet another form of the present invention, hollow tube10comprises a second window35opposite first window35, and the distal end of clamping rod15is trifurcated so as to form a first arm60carrying a pair of clamping surfaces47and a pair of second arms65, with each of the second arms65being outboard of first arm60and being biased out a window35. Thus, with this construction, suture can be clamped on either side of hollow tube10.

In another form of the present invention, the suture passer may further comprise a push rod to assist in ejecting suture S from window35. The push rod may be a component separate from clamping rod15(but slidably movable relative thereto), or it may be integrated with clamping rod15(e.g., slidably movable thereon).

Looking next atFIGS.35A-35C, it is also possible to form novel suture passer5so that (i) first arm60is shorter than second arm65, and (ii) clamping surface47is formed on the outwardly biased second arm65(rather than on first arm60). In this form of the invention, funnel region75is formed between the distal end of shaft10and first arm60.FIGS.35D-35Fshow the novel suture passer ofFIGS.35A-35Csecuring a suture S to the distal end of the suture passer.

Furthermore, if desired, where clamping surface47is formed on the outwardly biased second arm65(e.g., in the manner shown inFIGS.35A-35CandFIGS.35D-35F), first arm60may be omitted entirely, in which case the distal end of clamping rod15preferably comprises only outwardly biased second arm65.

In another form of the present invention, and looking now atFIGS.35G-35I, novel suture passer5may be constructed so that first arm60(carrying clamping surface47) is outwardly biased, so that first arm60(and clamping surface47) extends out window35when clamping rod15is moved distally. In this form of the invention, the funnel region75is formed between the distal end of shaft10and first arm60.FIGS.35J-35Lshow the novel suture passer ofFIGS.35G-35Isecuring a suture S to the distal end of the suture passer.

Furthermore, if desired, where first arm60is outwardly biased and carries clamping surface47(e.g., in the manner shown inFIGS.35G-35IandFIGS.35J-35L), second arm65may be omitted entirely, in which case the distal end of clamping rod15preferably comprises only outwardly biased first arm60(with clamping surface47).

In still another form of the present invention, and looking now atFIGS.35M-35O, novel suture passer5may be constructed so that both first arm60(carrying clamping surface47) and second arm65are outwardly biased, so that both first arm60(and clamping surface47) and second arm65extend out window35when clamping rod15is moved distally. In this form of the invention, funnel region75is formed between first arm60and second arm65.FIGS.35P-35Rshow the novel suture passer ofFIGS.35M-35Osecuring a suture S to the distal end of the suture passer.

In another form of the present invention, and looking now atFIGS.36-40, window35may be eliminated, and clamping rod15may clamp suture S against the distal end surface80of hollow tube10.

Again, if desired, and looking now atFIGS.40A and40B, second arm65of suture passer5may include a plurality of suture-engaging projections76on its distal side. As noted above, suture-engaging projections76allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm65, whereby to facilitate manipulation of suture S via engagement with second arm65. Thus, for example, with the construction shown inFIGS.40A and40B, if the user needs to move the suture S about a surgical site, the user can “grip” the suture S with the suture-engaging projections76of second arm65and “drag” the suture S into a desired position. In another example, the suture-engaging projections76of second arm65can assist in dragging suture S against the distal end of hollow tube10. More particularly, as the clamping rod15is moved proximally in hollow tube10, the second arm65retracts into the lumen of hollow tube10. As it does so, if the suture S is in contact with the suture-engaging projections76of second arm65, suture S will be drawn into engagement with the distal end of hollow tube10and then clamped in place by first arm60.

Alternatively, if desired, second arm65of suture passer5may include a plurality of suture-engaging projections76on its proximal side (e.g., in a manner analogous to that shown inFIGS.29C and29D). Again, suture-engaging projections76allow the user to more aggressively engage (e.g., in a contact or frictional sense) suture S with second arm65, whereby to facilitate manipulation of suture S via engagement with second arm65.

Again, it will be appreciated that, if desired, suture-engaging projections76may also be provided on both the distal and proximal sides of second arm65, and/or on one or both lateral sides of second arm65.

It will be appreciated that suture-engaging projections76essentially constitute a suture engaging surface on second arm65so as to allow second arm65to 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 arm65may be formed with a variety of geometries, e.g., barbs, fingers or other surface texturing which increases the frictional aspects of second arm65at a desired location or locations.

Furthermore, if desired, and looking now atFIGS.41-47, the distal end surface80of hollow tube10can be disposed substantially perpendicular to the longitudinal axis of hollow tube10, whereby to enhance clamping of suture S against distal end surface80of hollow tube10. In this construction, it may be desirable to provide a sharp point85to the distal end of first arm60, in order to facilitate passage of the suture passer through tissue.

Handle

As noted above, suture passer5preferably comprises a handle23, and handle23preferably comprises an actuator72which actuates clamping rod15so as to clamp and/or release suture S. If desired, actuator72may comprise a lock or detent which maintains the position of clamping rod15relative to hollow tube10. 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).

Actuator72may also comprise a spring to bias clamping rod15proximally or distally. In one preferred form of the invention, this spring biases the clamping rod in a proximal direction (for example, to clamp suture S between clamping surface47and inclined surface45).

Novel “Spear” Suture Passer

Looking next atFIGS.48-60, there is shown a novel suture passer105also formed in accordance with the present invention. Suture passer105will sometimes hereinafter be referred to as the “spear” suture passer.

More particularly, the spear suture passer105generally comprises an outer shaft tube110, an inner guide tube112fixedly disposed within the interior of outer shaft tube110, and a suture spear116slidably disposed within the lumen of inner guide tube112, as will hereinafter be discussed in further detail.

More particularly, outer shaft tube110comprises a distal end120preferably terminating in a sharp point122, and a proximal end125preferably terminating in a handle123, with a lumen130extending therebetween. It will be appreciated that the pointed outer shaft tube110essentially comprises a hollow needle adapted to pierce tissue.

Outer shaft tube110further comprises a window135which extends radially into the outer shaft tube and communicates with lumen130. Window135is sized so as to selectively receive a suture S therein, as will hereinafter be discussed in further detail. Window135comprises a pair of distal surfaces140, a pair of proximal surfaces145, and a pair of side surfaces146. Preferably, distal surfaces140and proximal surfaces145extend substantially perpendicular to the longitudinal axis of outer shaft tube110(FIG.49), and side surfaces146preferably extend substantially parallel to the longitudinal axis of outer shaft tube110(FIG.50). Distal surfaces140are preferably spaced from proximal surfaces145by a distance which is somewhat larger than the diameter of suture S, so that window135provides an adequate seat for suture S, as will hereinafter be discussed in further detail.

Outer shaft tube110is 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 invention, the distal end120of outer shaft tube110is curved (see, for example,FIGS.49,58and59), however, it should also be appreciated that outer shaft tube110can be formed in other configurations well known in the art (e.g., straight, etc.).

Inner guide tube112comprises a distal end150and a proximal end155, with a lumen156extending therebetween. Inner guide tube112is fixedly disposed within outer shaft tube110so that the distal end150of inner guide tube112terminates proximal to window135in outer shaft tube110, with lumen156of inner guide tube112being substantially aligned with the center of window135. The distal end150of inner guide tube112preferably terminates just proximal to window135of outer shaft tube110. See, for example,FIGS.50,52and53. As will hereinafter be discussed, inner guide tube112acts as a guide and stiffening member for suture spear116, which is selectively extendable out of the inner guide tube (and hence selectively extendable across window135) and selectively withdrawable back into the inner guide tube (and hence selectively withdrawable out of window135).

Suture spear116comprises a distal end158and a proximal end159. Distal end158of suture spear116terminates in a point161. It will be appreciated that suture spear116essentially comprises a needle which, as will hereinafter be discussed, is adapted to pierce suture. Suture spear116is slidably disposed within lumen156of inner guide tube112, such that suture spear116can extend across window135(FIG.52) or be withdrawn from window135(FIG.53). Preferably the proximal end159of suture spear116extends out of the proximal end155of inner guide tube112and is connected to an actuator172(e.g., a thumb slide) which is movably mounted to handle123, such that movement of actuator172relative to handle123will cause movement of suture spear116relative to inner guide tube112(and hence relative to outer shaft tube110). Specifically, movement of actuator172relative to handle123will cause the distal end of suture spear116to intrude across, or be withdrawn from, window135of outer shaft tube110.

It should be appreciated that the distal end of inner guide tube112is positioned within outer shaft tube110so that the inner guide tube (and hence the suture spear116) is aligned with a suture S that is laid in window135so as to ensure that suture spear116can 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 passer105by (i) moving suture spear116proximally so that the distal end158of suture spear116is withdrawn from window135of outer shaft tube110, in the manner shown inFIG.54(e.g., by moving actuator172proximally relative to handle123); (ii) positioning the suture S in window135(FIG.55); and (iii) moving suture spear116distally (e.g., by moving actuator172distally relative to handle123) so as to cause suture spear116to “spear” (e.g., penetrate) suture S, as shown inFIG.56, whereby to secure suture S to suture passer105.

It will also be appreciated that, on account of the foregoing construction, a speared piece of suture S (FIG.56) may thereafter be released from suture passer105by (a) moving suture spear116proximally (FIG.57) so as to “unspear” suture S; and (b) causing suture S to be withdrawn from window135.

Using the Novel “Spear” Suture Passer to Pass Suture from the Near Side of Tissue to the Far Side of Tissue

In one preferred form of the present invention, and looking now atFIGS.61-64, the novel suture passer105can 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 passer105may 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 passer105by retracting suture spear116out of window135of outer shaft tube110(FIG.54), guiding suture S into window135(FIG.55), and then advancing suture spear116distally through suture S (FIG.56), whereby to secure suture S to suture passer105. SeeFIG.61.

Suture passer105is then advanced distally so that window135passes through tissue T, whereby to carry suture S through the tissue (FIG.62). With suture S extending through tissue T, and looking now atFIG.63, suture spear116is retracted proximally so as to release suture S from suture passer105, and then suture passer105and/or suture S are manipulated so that suture S is clear of window135(FIG.63). Suture passer105may then be withdrawn back through tissue T, leaving suture S extending through tissue T, as shown inFIG.64.

Using the Novel “Spear” Suture Passer to Draw Suture from the Far Side of Tissue to the Near Side of Tissue

In another preferred form of the present invention, the spear suture passer105can 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 passer5on the far side of the tissue T. This is done by first passing suture passer105through tissue T so that window135resides on the far side of the tissue, and then moving suture spear116proximally so that suture spear116is withdrawn from window135(if the suture spear has not already been withdrawn from window135). Suture S (disposed on the far side of tissue T) is then positioned into window135, and suture spear116is advanced distally so as to spear suture S and secure the suture to suture passer105. Outer shaft tube110is then retracted proximally through tissue T, carrying suture S therethrough. If desired, suture S can then be released from suture passer105by moving suture spear116distally.

Significantly, by alternating the aforementioned antegrade suture passing procedure (FIGS.61-64) 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 passer105may 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 tube110is 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.

As described above, the novel suture passer105has 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 passer105from the portal through which the suture passer105is 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.

If desired, the function of the inner guide tube112can be replaced by a rod186with a slot187, as shown inFIG.65. This rod186could also have other cross-sectional shapes (such as that of a ribbon, etc.) that act to constrain the suture spear116to the desired position relative to the window135. 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 tube112can also be incorporated into the outer shaft tube110. For example, the outer shaft tube110can have a lumen130which is offset towards window135, e.g., as shown inFIG.66.

Additionally, suture spear116can occupy the entire internal diameter of lumen130of outer shaft tube110. In this embodiment, and as shown inFIG.67, the suture spear116is a rod with a sharpened feature188(e.g., a point) located in the window135. In this embodiment, the inner guide tube112is not required.

Additional Novel Suture Passer

Looking next atFIGS.68-81, there is shown a novel suture passer205formed in accordance with the present invention. Suture passer205generally comprises a hollow tube210and a clamping rod215slidably disposed within the lumen of hollow tube210, as will hereinafter be discussed in further detail.

More particularly, hollow tube210comprises a distal end220preferably terminating in a sharp point225, and a proximal end230preferably terminating in a handle235, with a lumen240extending therebetween. It will be appreciated that the pointed hollow tube210essentially comprises a hollow needle adapted to pierce tissue.

Hollow tube210further comprises a cutaway245disposed just proximal to sharp point225and which communicates with lumen240. Cutaway245preferably comprises a pair of longitudinally-extending edges250which terminate at their proximal ends at a circumferentially-extending edge255. Preferably circumferentially-extending edge255is recessed at260so as to form seats for a suture grasped by suture passer205, as will hereinafter be discussed. Alternatively, recess260can be omitted from circumferentially-extending edge255(e.g., circumferentially-extending edge255can be formed with a substantially “flat” profile).

Hollow tube210is 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 invention, the distal end220of hollow tube210is curved, however, it should be appreciated that hollow tube210can be formed in other configurations well known in the art (e.g., straight, compound curves, etc.).

Clamping rod215comprises a distal end265and a proximal end270. Distal end265of clamping rod215is bifurcated so as to form a first arm275and a second arm280. The distal ends of first arm275and second arm280are biased laterally so that first arm275and second arm280will extend both distally and laterally when the distal ends of first arm275and second arm280are advanced distally out of the distal end of hollow tube210, as will hereinafter be discussed in further detail. Preferably first arm275and second arm280have different degrees of lateral bias so that they will together define a funnel region therebetween when the distal ends of first arm275and second arm280are advanced distally out of the distal end of hollow tube210, as will hereinafter be discussed in further detail.

More particularly, first arm275comprises a clamping surface285, with clamping surface285extending radially from the longitudinal axis of clamping rod215. Clamping surface285may take the form of a hook, as shown in the construction illustrated inFIGS.68-81. This hook helps trap the suture S between clamping surface285of clamping rod215and the aforementioned recesses260of circumferentially-extending edge255of hollow tube210, in the manner shown inFIGS.77and78.

First arm275is outwardly biased so that when first arm275advances along cutaway245, first arm275passes radially outwardly through the cutaway so as to project at an angle of approximately 60 degrees relative to the adjacent longitudinal axis of hollow tube210, whereby to create one half of a funnel region290established between first arm275and second arm280when first arm275and second arm280extend out of cutaway245(FIG.73). To this end, first arm275is 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 invention, the entire clamping rod215is formed out of a superelastic material such as Nitinol. Second arm280extends parallel to first arm275when clamping rod215is disposed within lumen240of hollow tube210, with second arm280terminating proximally of first arm275, proximal of clamping surface285(FIG.70). Second arm280comprises a recess295at its distal tip. Recess295forms a seat for suture S at the distal tip of second arm280, such that when a suture S is seated in cutaway245and second arm280thereafter extends out of cutaway245, recess295in second arm280will engage suture S and carry suture S away from cutaway245, whereby to help separate suture S from suture passer205. In one preferred form of the invention, recess295comprises a distal finger300, a proximal finger305and a groove310formed therebetween. If desired, distal finger300and proximal finger305may have substantially the same length and/or width.

Second arm280is outwardly biased so that when second arm280advances along cutaway245, second arm280passes radially outwardly through the cutaway245so as to project at an angle of approximately 90 degrees relative to the adjacent longitudinal axis of hollow tube210, whereby to create the aforementioned funnel region290between first arm275and second arm280when first arm275and second arm280extend out of cutaway245. To this end, second arm280is 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 invention, the entire clamping rod215is formed out of a superelastic material such as Nitinol.

The gap between first arm275and second arm280(see gap G inFIG.76) 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 arm275and second arm280, which could effectively jam the components, but not so large that the transfer of suture S from first arm275to second arm280is undermined. In one preferred form of the invention, the gap between first arm275and second arm280is approximately 1-3 times the diameter of the suture, and preferably about 1.5 times the diameter of the suture.

In one preferred form of the present invention, second arm280may comprise a compound curve315(FIG.73) so as to facilitate proper disposition of second arm280when it is projected distally and laterally out of cutaway245.

If desired, the degree of the outward bias of first arm275and second arm280can be varied from the angles described above, e.g., first arm275can extend at an angle of approximately 45 degrees relative to the adjacent longitudinal axis of hollow tube210when first arm275advances out of the distal end of hollow tube210, and second arm280can extend at an angle of approximately 135 degrees relative to the adjacent longitudinal axis of hollow tube210when second arm280advances out of the distal end of hollow tube210. In one form of the invention, first arm275can extend at an angle of 0-90 degrees relative to the adjacent longitudinal axis of hollow tube210, and second arm280can extend at an angle of 20-160 degrees relative to the adjacent longitudinal axis of hollow tube210(but in any case at an angle which is less 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 end270of clamping rod215extends through lumen240of hollow tube210and is connected to an actuator320which is movably mounted to handle235, such that movement of actuator320relative to handle235causes movement of clamping rod215relative to hollow tube210.

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 passer205by (i) moving clamping rod215to the position shown inFIGS.72and73(e.g., by moving actuator320distally relative to handle235) so that first arm275and second arm285extend distally and laterally out of cutaway245and create the aforementioned funnel region290; (ii) positioning the suture S in funnel region290(FIG.74), preferably moving suture passer205and/or suture S as appropriate so as to settle the suture S deep within funnel region290(i.e., close to or against the pair of longitudinally-extending edges250and/or the circumferentially-extending edge255, or hooking suture S with the clamping surface285of first arm275; and (iii) moving clamping rod215proximally (e.g., by moving actuator320proximally relative to handle235) so as to cause clamping surface285of first arm275to engage suture S (FIGS.75and76) and retract suture S proximally, whereby to clamp suture S against recesses260of circumferentially-extending edge255of hollow tube210, as shown inFIGS.77and78. In this respect it will be appreciated that the creation of the funnel region290(established between the extended first arm275and the extended second arm280) at the mouth of cutaway245facilitates guidance of suture S into clamping position, as shown inFIGS.74-78.

It will also be appreciated that, on account of the foregoing construction, a clamped piece of suture S may thereafter be released from suture passer205by (a) moving clamping rod215distally (FIGS.77-81) so as to space clamping surface285of first arm275away from recesses260of circumferentially-extending edge255of hollow tube210, whereby to release suture S from its clamped condition, and with recess295of second arm280engaging suture S and driving it distally and laterally, so that suture S moves clear of cutaway245(FIGS.79-81); and (b) causing suture S to be withdrawn from the suture passer, either by moving suture S relative to suture passer205, or by moving suture passer205relative to suture S, or by moving both suture S and suture passer205relative to one another.

It should be appreciated that, in one preferred form of the invention, when clamping rod215is moved proximally, both first arm275and second arm280are disposed within lumen230of hollow tube210, so that the distal end of suture passer205presents a smooth outer surface, whereby to facilitate passage of the distal end of suture passer205through tissue.

Using the Novel Suture Passer to Pass Suture from the Near Side of Tissue to the Far Side of Tissue

In one preferred form of the present invention, the novel suture passer205can 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 passer205may 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 rod215to its distalmost position so that first arm275and second arm280advance out of cutaway245, whereby to project the distal ends of the first and second arms out of the axis of hollow tube210and create the aforementioned funnel region290. Suture S is then guided into cutaway245using this funnel effect, either by moving suture S relative to suture passer205, or by moving suture passer205relative to suture S, or by moving both suture S and suture passer205relative to one another. If desired, the suture S may be tensioned so as to help draw it into cutaway245. Or suture S may be hooked with clamping surface285of first arm275. Clamping rod215is then retracted proximally so that clamping surface285of first arm275clamps suture S between clamping surface285of first arm275and recesses260of circumferentially-extending edge255of hollow tube210.

Suture passer205is then advanced distally so that cutaway245passes through tissue, whereby to carry suture S through the tissue. With suture S extending through the tissue, clamping rod215is advanced distally so that first arm275and second arm280extend out of cutaway245, thereby spacing clamping surface285from circumferentially-extending edge255of hollow tube210, whereby to release suture S from suture passer205and with second arm280driving suture S before it as second arm280advances distally and proximally out of cutaway245. SeeFIG.79. Preferably, second arm280can flex proximally slightly at the end of the distal stroke, whereby to allow suture S to “slip off” the distal end of second arm280. (seeFIG.81). In this respect it will be appreciated that second arm280is flexible, but also has column strength, so that second arm280can drive the suture S distally relative to hollow tube210, but then, as the portion of second arm280projecting out of hollow tube210gets longer and longer, the second arm280eventually “flops over” under the drag of the suture S which is being pushed by second arm280, whereby to cause suture S to fall free of second arm280. Suture passer205and/or suture S are then manipulated so that suture S is clear of suture passer205. Clamping rod215is then moved proximally so as to retract first arm275and second arm280back into hollow tube210. Suture passer205may then be withdrawn back through the tissue, leaving suture S extending through the tissue.

Significantly, by providing second arm280of clamping rod215with a recess295, the suture being driven forward by second arm280of clamping rod215can 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 arm280of clamping rod215. 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 arm280out of a flexible, outwardly biased material, as the second arm280extends further and further out of hollow tube210, the drag on suture S will eventually cause second arm280to “flop over”, whereby to release the suture S from second arm280.

Using the Novel Suture Passer to Draw Suture from the Far Side of Tissue to the Near Side of Tissue

In another preferred form of the present invention, the novel suture passer205can 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 passer205on the far side of the tissue. This is done by first passing suture passer205through the tissue so that cutaway245resides on the far side of the tissue, and then moving clamping rod215distally so that first arm275and second arm280extend distally and proximally out of cutaway245, whereby to create the aforementioned funnel region290. This funnel effect is then used to guide a free suture (disposed on the far side of the tissue) into cutaway245, either by moving suture S relative to suture passer205, or by moving suture passer205relative to suture S, or by moving both suture S and suture passer205relative to one another. If desired, the suture S may be tensioned so as to help draw it into cutaway245. Or suture S may be hooked with clamping surface285of first arm275.

Next, clamping rod215is retracted proximally so as to releasably secure suture S between clamping surface285of first arm275and recesses260of circumferentially-extending edge255of hollow tube210. Suture passer205is then retracted proximally through the tissue, carrying suture S therethrough. Suture S can then be released from suture passer205by moving clamping rod215distally, whereby to cause second arm280to drive suture S out of cutaway245and clear of suture passer205.

Forming First Arm275without an Outward Bias

If desired, first arm275can be formed without an outward bias, so that only second arm280has an outward bias. In this form of the invention, the funnel region290is still formed between the distal ends of first arm275and second arm280, however, the funnel region290will extend at a different angle relative to the longitudinal axis of hollow tube210than where both first arm275and second arm280are outwardly biased.

Forming Second Arm280with a Modified Construction

If desired, and looking now atFIGS.82-84, second arm280may be formed without the aforementioned compound curve315.

Furthermore, if desired, recess295at the distal tip of second arm280may be formed with a different geometry, e.g., so as to facilitate separation of suture S from second arm280at the end of the second arm's distal stroke. By way of example but not limitation, recess295may comprise a longer distal finger300and a shorter proximal finger305, with the groove310being formed therebetween. As a result of this construction, when a suture S is seated in cutaway245and second arm280thereafter extends out of cutaway245, recess295in second arm280will engage suture S and carry suture S away from cutaway245, and the shorter proximal finger305will thereafter facilitate separation of suture S from suture passer205. In effect, and as best seen inFIG.84, as second arm280moves further and further out of hollow tube210, the second arm280becomes progressively less supported by hollow tube210which, at the end of the second arm's distal stroke and in combination with the shorter proximal finger305, allows the suture S to fall away from second arm280in the proximal direction. In this respect it will also be appreciated that where suture S extends through tissue proximal to second arm280, friction between suture S and this tissue during distal movement of second arm280imposes a proximally-directed force on suture S, which (i) helps cause second arm280to bend proximally at the end of its distal stroke, thereby directing groove310more proximally, and (ii) helps suture S to pull off second arm280. If desired, second arm280can be formed with proximal finger305omitted, so that second arm280comprises only the distal finger300.

Additionally, if desired, and looking now atFIGS.85and86, recess295at the distal end of second arm280may be replaced by a relatively short spike325. In this form of the invention, when a suture S is seated in cutaway245and second arm280thereafter extends out of cutaway245, spike325at the distal end of second arm280piercingly engages suture S and help hold suture S on the distal end of second arm280as second arm280extends out of cutaway245, whereafter the relatively short spike325allows suture S to separate from suture passer205. More particularly, it will be appreciated that as second arm280moves further and further out of hollow tube210, the second arm280becomes progressively less supported by hollow tube210which, in combination with the relatively short length of spike325, allows the suture S to fall away from second arm280in the proximal direction. In this respect it will also be appreciated that where suture S extends through tissue proximal to second arm280, friction between suture S and this tissue during distal movement of second arm280imposes a proximally-directed force on suture S, which (i) helps cause second arm280to bend proximally at the end of its distal stroke, thereby directing spike325more proximally, and (ii) helps suture S to pull off second arm280.

Additional Aspects of the Invention

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 passer205may 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 tube210is 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 passer205has 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 passer205from the portal through which the suture passer205is 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.

Modifications

It should also be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.