Method and apparatus for passing suture through tissue

A suture passer comprising:

FIELD OF THE INVENTION

This invention relates to surgical apparatus and procedures in general, and more particularly to surgical apparatus and procedures for passing suture through tissue.

BACKGROUND OF THE INVENTION

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.

SUMMARY OF THE INVENTION

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

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

a hollow tube, the hollow tube comprising a distal end, a proximal end, a lumen extending from the distal end to the proximal end, and a window formed in the sidewall of the hollow tube, the window communicating with the lumen; and a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, one of the first and second arms extending distally of the other of the first and second arms and including a clamping surface, and at least one of the first and second arms being outwardly biased such that when the clamping rod is moved distally so that the distal end of the at least one outwardly biased arm is adjacent to the window, the distal end of the at least one outwardly biased arm extends outwardly through the window.

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

providing a suture passer comprising:a hollow tube, the hollow tube comprising a distal end, a proximal end, a lumen extending from the distal end to the proximal end, and a window formed in the sidewall of the hollow tube, the window communicating with the lumen; anda clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, one of the first and second arms extending distally of the other of the first and second arms and including a clamping surface, and at least one of the first and second arms being outwardly biased such that when the clamping rod is moved distally so that the distal end of the at least one outwardly biased arm is adjacent to the window, the distal end of the at least one outwardly biased arm extends outwardly through the window; positioning the clamping rod so that the at least one outwardly biased arm extends out of the window;

positioning at least one of the suture passer and the suture so that the suture is disposed in the window;

moving the clamping rod proximally so that the clamping surface clamps the suture to the hollow tube; and

moving the suture passer so that the suture is passed through the object.

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

a hollow tube, the hollow tube comprising a pointed distal end, a proximal end and a lumen extending from the distal end to the proximal end; and

a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, the first arm extending distally of the second arm and including a clamping surface, and the second arm being outwardly biased such that when the clamping rod is moved distally so that the distal end of the second arm extends out of the distal end of the hollow tube, the distal end of the second arm extends laterally of the hollow tube.

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

providing a suture passer comprising:a hollow tube, the hollow tube comprising a pointed distal end, a proximal end and a lumen extending from the distal end to the proximal end; anda clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, the first arm extending distally of the second arm and including a clamping surface, and the second arm being outwardly biased such that when the clamping rod is moved distally so that the distal end of the second arm extends out of the distal end of the hollow tube, the distal end of the second arm extends laterally of the hollow tube;

positioning the clamping rod so that the second arm extends out of the distal end of the hollow tube;

positioning at least one of the suture passer and the suture so that the suture is disposed between the clamping surface and the distal end of the hollow tube;

moving the clamping rod proximally so that the clamping surface clamps the suture to the hollow tube; and

moving the suture passer so that the suture is passed through the object.

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

a shaft comprising a distal end, a proximal end, a lumen extending from the proximal end toward the distal end, and a window formed in the sidewall of the shaft, the window communicating with the lumen; and

a suture spear movable within the lumen of the shaft, the suture spear comprising a distal end and a proximal end, the distal end being pointed to pierce a suture located in the window.

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

providing a suture passer comprising:a shaft comprising a distal end, a proximal end, a lumen extending from the proximal end toward the distal end, and a window formed in the sidewall of the shaft, the window communicating with the lumen; anda suture spear movable within the lumen of the shaft, the suture spear comprising a distal end and a proximal end, the distal end being pointed to pierce a suture located in the window.

positioning the suture spear so that it is disposed proximal to the window;

positioning at least one of the suture passer and the suture so that the suture is disposed in the window;

moving the suture spear distally so that the suture spear extends into the suture disposed in the window; and

moving the suture passer so that the suture is passed through the object.

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

a hollow tube, the hollow tube comprising a distal end, a proximal end, a lumen extending from the distal end to the proximal end, and a window formed in the sidewall of the hollow tube, the window communicating with the lumen; and

a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end including a clamping surface, and the distal end being outwardly biased such that when the clamping rod is moved distally so that the distal end of the clamping rod is adjacent to the window, the distal end of the clamping rod extends outwardly through the window.

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

providing a suture passer comprising:a hollow tube, the hollow tube comprising a distal end, a proximal end, a lumen extending from the distal end to the proximal end, and a window formed in the sidewall of the hollow tube, the window communicating with the lumen; anda clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end including a clamping surface, and the distal end being outwardly biased such that when the clamping rod is moved distally so that the distal end of the clamping rod is adjacent to the window, the distal end of the clamping rod extends outwardly through the window;

positioning the clamping rod so that the distal end of the clamping rod extends out of the window;

positioning at least one of the suture passer and the suture so that the suture is disposed in the window;

moving the clamping rod proximally so that the clamping surface clamps the suture to the hollow tube; and

moving the suture passer so that the suture is passed through the object.

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

a hollow tube, the hollow tube comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end; and

a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, one of the first and second arms extending distally of the other of the first and second arms and including a clamping surface;

wherein at least one of the first arm and the second arm comprises a friction-enhancing surface for facilitating manipulation of a suture via engagement of the suture with the friction-enhancing surface.

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

providing a suture passer comprising:a hollow tube, the hollow tube comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end; anda clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, one of the first and second arms extending distally of the other of the first and second arms and including a clamping surface;wherein at least one of the first arm and the second arm comprises a friction-enhancing surface for facilitating manipulation of a suture via engagement of the suture with the friction-enhancing surface;

positioning the clamping rod so that at least one of the first arm and the second arm extends out of the hollow tube;

manipulating a suture via engagement of the suture with the friction-enhancing surface on the at least one of the first arm and the second arm;

positioning at least one of the suture passer and the suture so that the suture is disposed between the first arm and the second arm;

moving the clamping rod proximally so that the clamping surface clamps the suture to the hollow tube; and

moving the suture passer so that the suture is passed through the object. In another form of the present invention, there is provided a suture passer comprising:

a hollow tube, the hollow tube comprising a pointed distal end, a proximal end and a lumen extending from the distal end to the proximal end; and

a clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, the first arm extending distally of the second arm and including a clamping surface, and the second arm being outwardly biased such that when the clamping rod is moved distally, the distal end of the second arm extends laterally of the hollow tube, and wherein the second arm is configured to releasably hold a suture to the distal end of the second arm.

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

providing a suture passer comprising:a hollow tube, the hollow tube comprising a pointed distal end, a proximal end and a lumen extending from the distal end to the proximal end; anda clamping rod slidably received in the lumen of the hollow tube, the clamping rod comprising a distal end and a proximal end, the distal end being bifurcated into a first arm and a second arm, the first arm extending distally of the second arm and including a clamping surface, and the second arm being outwardly biased such that when the clamping rod is moved distally so that the distal end of the second arm extends out of the distal end of the hollow tube, the distal end of the second arm extends laterally of the hollow tube, and wherein the second arm is configured to releasably hold a suture to the distal end thereof;

positioning the clamping rod so that the second arm extends out of the distal end of the hollow tube;

positioning at least one of the suture passer and the suture so that the suture is disposed between the clamping surface and the distal end of the hollow tube;

moving the clamping rod proximally so that the clamping surface clamps the suture to the hollow tube;

moving the suture passer so that the suture is passed through the object; and

moving the clamping rod distally so that the distal end of the second arm moves the suture away from the hollow tube.

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

a hollow tube, said hollow tube comprising a distal end, a proximal end, and a lumen extending from said distal end to said proximal end; and

a suture manipulation rod slidably received in said lumen of said hollow tube and selectively projectable out said distal end of said hollow tube, said suture manipulation rod comprising a distal end and a proximal end, said distal end of said suture manipulation rod being bifurcated into a first arm and a second arm, wherein said first arm includes a hook comprising a proximally oriented hooking surface and a return extending proximally of said hooking surface;

wherein said hollow tube and said suture manipulation rod are sized so that said suture manipulation rod may capture a suture disposed adjacent to said distal end of said hollow tube and draw the suture into said lumen of said hollow tube, and further wherein, after a suture has been drawn into said lumen of said hollow tube, distal movement of said suture manipulation rod causes the suture to be expelled from said hollow tube.

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

providing a suture passer comprising:a hollow tube, said hollow tube comprising a distal end, a proximal end, and a lumen extending from said distal end to said proximal end; anda suture manipulation rod slidably received in said lumen of said hollow tube and selectively projectable out said distal end of said hollow tube, said suture manipulation rod comprising a distal end and a proximal end, said distal end of said suture manipulation rod being bifurcated into a first arm and a second arm, wherein said first arm includes a hook comprising a proximally oriented hooking surface and a return extending proximally of said hooking surface;wherein said hollow tube and said suture manipulation rod are sized so that said suture manipulation rod may capture a suture disposed adjacent to said distal end of said hollow tube and draw a suture into said lumen of said hollow tube, and further wherein, after a suture has been drawn into said lumen of said hollow tube, distal movement of said suture manipulation rod causes the suture to be expelled from said hollow tube;

positioning said suture manipulation rod so that said suture manipulation rod extends out of said hollow tube;

positioning at least one of said suture passer and the suture so that the suture is disposed between said first arm and said second arm;

moving said suture manipulation rod proximally so that said suture manipulation rod captures the suture and draws the suture into said lumen of said hollow tube; and

moving said suture passer so that the suture is passed through the object.

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

a hollow tube, said hollow tube comprising a distal end, a proximal end, and a lumen extending from said distal end to said proximal end; and

a suture manipulation rod slidably received in said lumen of said hollow tube and selectively projectable out said distal end of said hollow tube, said suture manipulation rod comprising a distal end and a proximal end, said distal end of said suture manipulation rod comprising a hook comprising a proximally oriented hooking surface and a return extending proximally of said hooking surface, and a pushing surface disposed proximally of said return of said hook of said suture manipulation rod;

wherein said hollow tube and said suture manipulation rod are sized so that said suture manipulation rod may capture a suture disposed adjacent to said distal end of said hollow tube and draw the suture into said lumen of said hollow tube, and further wherein, after a suture has been drawn into said lumen of said hollow tube, distal movement of said suture manipulation rod causes the suture to be expelled from said hollow tube.

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

providing a suture passer comprising:a hollow tube, said hollow tube comprising a distal end, a proximal end, and a lumen extending from said distal end to said proximal end; anda suture manipulation rod slidably received in said lumen of said hollow tube and selectively projectable out said distal end of said hollow tube, said suture manipulation rod comprising a distal end and a proximal end, said distal end of said suture manipulation rod comprising a hook comprising a proximally oriented hooking surface and a return extending proximally of said hooking surface, and a pushing surface disposed proximally of said return of said hook of said suture manipulation rod;wherein said hollow tube and said suture manipulation rod are sized so that said suture manipulation rod may capture a suture disposed adjacent to said distal end of said hollow tube and draw the suture into said lumen of said hollow tube, and further wherein, after a suture has been drawn into said lumen of said hollow tube, distal movement of said suture manipulation rod causes the suture to be expelled from said hollow tube;

positioning said suture manipulation rod so that said suture manipulation rod extends out of said hollow tube;

positioning at least one of said suture passer and the suture so that the suture is disposed between said hooking surface and said pushing surface;

moving said suture manipulation rod proximally so that said suture manipulation rod captures the suture and draws the suture into said lumen of said hollow tube; and

moving said suture passer so that the suture is passed through the object.

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. 10 and 11.

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 adjacent longitudinal axis of first arm60(FIG. 6) (i.e., the longitudinal axis of first arm60at the point adjacent to where second arm65advances outwardly through window35), and more preferably at an angle of approximately 30-90 degrees to the instantaneous longitudinal axis of first arm60, whereby to create a funnel region75(FIG. 7) between 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. 5 and 6(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. 10 and 11. 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. 8 and 9) 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. 19 and 20). 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. 24 and 25).

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 and 29B, 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 and 29B, 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 and 29D, 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. 30 and 31. 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. 32 and 33. 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 and 40B, 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 and 40B, 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 and 29D). 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 proximal surface45).

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, 58 and 59), 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 end150(FIG. 52) and a proximal end155(FIG. 60), 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, 52 and 53. 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 end158(FIG. 52) and a proximal end159(FIG. 60). 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. 77 and 78.

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(i.e., the longitudinal axis of hollow tube210at the point adjacent to where first arm275advances through cutaway245), 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(i.e., the longitudinal axis of hollow tube210at the point adjacent to where second arm280advances through cutaway245), 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 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 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. 72 and 73(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. 75 and 76) and retract suture S proximally, whereby to clamp suture S against recesses260of circumferentially-extending edge255of hollow tube210, as shown inFIGS. 77 and 78. 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 lumen240of 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 adjacent longitudinal axis of hollow tube210than when 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. 85 and 86, 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 helps 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 Construction Wherein the First and Second Arms Extend at Smaller Angles Relative to the Adjacent Longitudinal Axis of the Hollow Tube

Looking next atFIGS. 87-91, there is shown a construction wherein first arm275and second arm280both extend at smaller angles (than those previously disclosed) relative to the adjacent longitudinal axis of hollow tube210. More particularly, in this form of the invention, first arm275extends substantially parallel to the adjacent longitudinal axis of hollow tube210, and second arm280extends at an angle of approximately 35 degrees relative to the adjacent longitudinal axis of hollow tube210. It has been found that by configuring second arm280so that it extends at a smaller angle (than those previously disclosed) relative to the adjacent longitudinal axis of hollow tube210, 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 invention, second arm280comprises a plurality of bends (e.g., two bends281A and281B) which act in an “additive” fashion so as to together provide an increased opening for funnel region290.

In addition, in this form of the invention, second arm280is configured so that it extends laterally (of hollow tube210) “sooner” (i.e., when clamping rod215is at a more proximal position than previously disclosed) so as to open funnel region290closer to the distal end of hollow tube210. This is a consequence of locating bend281A closer to the distal end of second arm280. As a result, the tool can be used to retrieve suture without having to fully extend first arm275and second arm280, which can sometimes be difficult to do in constrained spaces.

FIGS. 87-88show first arm275and second arm280in a partially-extended position (i.e., in a position where suture can be adequately retrieved), whileFIGS. 89-90show first arm275and second arm280in a fully-extended position (i.e., in a position where suture can be fully advanced when being passed through tissue).FIG. 91shows clamping rod215prior to assembly into suture passer205.

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.

Additional Suture Passer Construction

In the preceding disclosure, there are shown various novel suture passers (e.g., novel suture passer5, novel suture passer105, novel suture passer205, 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,FIGS. 12-18, where novel suture passer5is 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,FIGS. 19-25, where novel suture passer5is 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 atFIGS. 92-112, there is now provided a further novel suture passer205A which is generally similar to the novel suture passer205discussed above, except that hollow tube210A and clamping rod215A are sized so that clamping rod215A can draw suture S within the interior of hollow tube210A, without causing clamping surface285A of clamping rod215A to trap suture S against the circumferentially-extending edge255A of hollow tube210A (as is the case with suture passer205described above and shown in FIGS.68-91). Thus, in this form of the invention, “clamping” surface285A functions more like a “hooking” surface than a “clamping” surface, and clamping rod215A functions more like a “hooking” rod than a “clamping” rod. For the purposes of the following discussion, surface285A will be referred to herein as a hooking surface, and rod215A will be referred to herein as a hooking rod. The suture that is drawn within the interior of hollow tube210A is payed back out again when hooking rod215A moves distally within hollow tube210A and extends out the distal end of hollow tube210A. In one preferred form of the invention, the suture that is drawn into the interior of hollow tube210A is pushed back out of hollow tube210A by (i) pushing by hooking surface285A of first arm275A when hooking rod215A moves distally within hollow tube210A and extends out the distal end of hollow tube210A (inasmuch as the suture S releasably adheres to hooking surface285A by a creasing or crimping action during suture capture), as hereinafter discussed below, and/or (ii) pushing by the distal end of second arm280A when hooking rod215A moves distally within hollow tube210A and extends out the distal end of hollow tube210A, as hereinafter discussed below.

As a result of this construction, suture length can effectively be “stored” within the interior of hollow tube210A during antegrade passage of suture passer205A through tissue T, whereby to deploy an enlarged loop of suture S on the far side of tissue T when hooking rod215A is advanced out the distal end of hollow tube210A. 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 passer205A 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 passer205A 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 passer205A 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 tube210A, 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 tube210A a distance of 1 inch, then a suture loop comprising approximately 2 inches of suture S will be delivered out the end of hollow tube210A.

Thus, with the suture passer205A shown inFIGS. 92-112, a larger loop of suture S can be deployed on the far side of the tissue without requiring the first and second arms275A,285A of hooking rod215A to extend further out of the distal end of hollow tube210A.

FIGS. 92-95show suture passer205A with its hooking rod215A disposed within the interior of hollow tube210A.

FIGS. 96-98show suture passer205A with the distal end of its hooking rod215A projecting out the distal end of hollow tube210A. Note that inFIGS. 96-98, first arm275A of hooking rod215A is shown as extending at an angle to the local longitudinal axis of the distal end of hollow tube210A when first arm275A projects out of the distal end of hollow tube210A.

More preferably, and looking now atFIG. 99, first arm275A of hooking rod215A is configured to extend parallel to the local longitudinal axis of the distal end of hollow tube210A when first arm275A projects out of the distal end of hollow tube210A.

FIGS. 100-109show suture passer205A capturing a suture S by means of the interaction of first arm275A and second arm280A of hooking rod215A, and drawing a portion of that suture S within the interior of hollow tube210A by means of hooking surface285A of first arm275A of hooking rod215A.

FIGS. 110-112show suture passer205A releasing a suture which had been previously captured by suture passer205A and which had a portion of that suture “stored” within the interior of hollow tube210A, e.g., by using the distal end of second arm280A of hooking rod215A to push the “stored” suture back out of hollow tube210A.

As noted above, with this form of the invention, hooking surface285A of first arm275A functions like a hooking surface (i.e., to draw suture S into the interior of hollow tube210A) rather than as a clamping surface to clamp suture S against circumferentially-extending edge255A of hollow tube210A. Hooking surface285A of first arm275A may also help push suture S distally as hooking rod215A advances distally within and out of hollow tube210A, inasmuch as suture S releasably adheres to hooking surface285A 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 arm275A and the inner surface of hollow tube210A such that suture S can slide without binding as hooking rod215A is withdrawn into, and advanced out of, hollow tube210A, such that suture S can be drawn into hollow tube210A and be pushed out of hollow tube210A. 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 surface285A of hooking rod215A once suture S is drawn into hollow tube210A, the gap between the outer surface of the distal end of first arm275A and the inner surface of hollow tube210A cannot be so great as to allow suture S to prematurely slip off the hooking surface285A of hooking rod215A (i.e., to flip up and over the edge of the hook, then pass distally between the distal end of first arm275A and hollow tube210A). SeeFIG. 108. Thus, there is an optimally sized gap between the outer surface of the distal end of first arm275A and the inner surface of hollow tube210A which keeps suture S secure on hooking surface285A of first arm275A yet allows suture S to slide when hooking rod215A is moved within hollow tube210A.

By way of example but not limitation, where suture S is a size #2 orthopedic braided suture with an external diameter of 0.021 inches, the distal end of first arm275A may have an outer diameter of approximately 0.045 inches and hollow tube210A may have an inner diameter of 0.063 inches. As such, the inner diameter of hollow tube210A is approximately 300% larger than the diameter of suture S. It has been discovered that best results are achieved where the inner diameter of outer tube210A is preferably between approximately 200% to 600% larger than the diameter of suture S, and more preferably approximately 300% to 500% larger than the diameter of suture S. Also, as such, there is a 0.009 inch gap (between the outer surface of the distal end of first arm275A and the inner surface of hollow tube210A) for suture S to pass between the outer surface of the distal end of first arm275A and the inner surface of hollow tube210A. A size #2 orthopedic braided suture has a diameter of approximately 0.021 inches; therefore, it is compressed to approximately 0.009 inches (i.e., the size of the gap between the outer surface of the distal end of first arm275A and the inner surface of hollow tube210A), or to approximately 43% of its original diameter (seeFIG. 108) when the suture is drawn into hollow tube210A by hooking rod215A. It has been found that if the outer diameter of the distal end of first arm275A is 0.048 inches (i.e., the suture compresses to 36% of its original diameter), suture S may bind to hollow tube210A as hooking rod215A moves within hollow tube210A. Preferably, suture S is compressed to greater than approximately 36% of its original diameter when suture S is disposed between the outer surface of the distal end of first arm275A and the inner diameter of hollow tube210A.

It should be appreciated that the distance that hooking surface285A is recessed (i.e., distance “L” inFIG. 95) within the distal end of first arm275A also affects the holding force of suture S when suture S is held within hollow tube210A. 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 arm275A is 0.045 inches and the inner diameter of hollow tube210A is 0.063 inches and hooking surface285A is recessed 0.027 inches, when suture S has been drawn into the interior of hollow rod210A by hooking rod215A and tension is thereafter applied to one limb of suture S in an approximately longitudinal direction, a #2 orthopedic suture will be held with approximately 5-9 lbs. of force before releasing from hooking rod215A.

It should also be appreciated that the shape and size of the hooking surface285A of first arm275A can affect the ability of suture S to exit the recess of the hook of first arm275A. For example, when first arm275A is fully extended out of hollow tube210A and second arm280A is biased away from first arm275A, a hooking surface285A having a smaller radius R (FIG. 95) may tend to bind the suture and prevent it from exiting the recess of first arm285A, and a hooking surface285A of a larger radius R enables the suture to more freely exit the recess of first arm285A. Conversely, a hooking surface285A having a radius R of a large size may not sufficiently bind suture S. In a preferred embodiment, hooking surface285A has a radius R of 0.011 inches, or a radius R approximately equal to one half the diameter of suture S when suture S is a #2 orthopedic suture. Hooking surface285A of first arm275A may function to help push suture S distally as hooking rod215A advances distally within hollow tube210A. More particularly, suture passer205A may rely on a degree of binding between hooking surface285A of hooking rod215A 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 surface285A of first arm275A as suture S is drawn into hollow tube210A due to tension on suture S. The “crease” or “crimp” of the suture will create a slight adhesion of the suture S to hooking surface285A of first arm275A, so that suture S will be carried distally with first arm275A when hooking rod215A moves distally within and out of hollow tube210A.

It should also be appreciated that with this form of the invention, second arm280A may also “push” suture S distally as hooking rod215A advances distally within and out of hollow tube210A.

As described above, suture S will preferably bind to hooking surface285A of first arm275A when suture S is drawn into hollow tube210A. However, in some circumstances, upon distal movement of hooking rod215A within hollow tube210A (i.e., when suture S is payed back out of suture passer205A) suture S may dislodge from hooking surface285A of first arm275A. In this event, the distal end of second arm280A engages suture S and pushes it distally. In other words, if suture S dislodges from hooking surface285A of first arm275A, the distal end of second arm280A then “pushes” suture S distally as hooking rod215A advances distally within hollow tube210A and extends out the distal end of hollow tube210A (up until the point when second arm280A biases laterally away from first arm275A). The thickness TH of second arm280A (FIG. 95) must be sufficiently large so as not to pierce suture S during such distal movement of hooking rod215A. To this end, it has been found that thickness TH of second arm280A should be minimally at least as large as 50% of the diameter of suture S, and more preferably approximately equal to the diameter of suture S.

Second arm280A 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 passer205A has passed suture S through tissue, suture passer205A can be used to thereafter retrieve suture S, either after suture passer205A has been passed through tissue at another location or directly (e.g., via access from a different direction). Inasmuch as second arm280A is biased away from first arm275A when the distal end of hooking rod215A extends out the distal end of hollow tube210A, suture S can be positioned in the gap between first arm275A and second arm280A (FIG. 100). When hooking rod215A is thereafter moved proximally, second arm280A will close toward first arm275A and capture suture S in the space SP between first arm275A and second arm280A (FIGS. 95, 101 and 102). Upon further proximal movement of hooking rod215A, as suture S engages circumferentially-extending edge255A of hollow tube210A, suture S may be held for pick-up by hooking surface285A of first arm275A (FIGS. 103 and 104) as hooking surface285A of first arm275A passes by circumferentially-extending edge255A of hollow tube210A. Upon still further proximal movement of clamping rod215, suture S is drawn into hollow tube210A (FIGS. 105-107).

The gap G (FIG. 95) between the proximal tip of the hook of first arm275A and the distal end of second arm280A must be large enough that second arm280A does not bind to the hook of first arm275A as the distal end of hooking rod215A passes through the curvature of hollow tube210A. In this respect it should be appreciated that the distal end of second arm280A will move towards the hook of first arm275A as hooking rod215A passes through a curvature (in the direction of second arm280A) in hollow tube210A. In other words, as hooking rod215A passes through a curvature (in the direction of second arm280A) in hollow tube210A, the gap G between the hook tip of first arm275A and the distal end of second arm280A will be reduced, since both the proximal tip of the hook of first arm275A and the distal end of second arm280A are offset from the central axis of hooking rod215A. Thus, the gap must be large enough to prevent binding between first arm275A and second arm280A as hooking rod215A traverses a curve in hollow tube210A. At the same time, the gap G between the hook tip of first arm275A and the distal end of second arm280must also not be so great so as to insufficiently retain suture S as suture S is being pushed distally in hollow tube210(i.e., if the gap G is too large, the suture may shift relative to clamping rod215and 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 arm275A and second arm280A. As described above, during retrieval of suture S, suture passer205A may be manipulated so as to place suture S between first arm275A and second arm280A (FIG. 100). Once suture S is in position, hooking rod215A is retracted proximally. As hooking rod215A is drawn into hollow tube210A, second arm280A is forced to close down towards first arm275A, trapping suture S between first arm275A and second arm280A (FIG. 101). If gap G is too large, second arm280A may miss suture S (such as, for example, if suture S is located distal to the distal end of second arm280A) and hence not capture suture S. Gap G is preferably approximately 0.040 inches in the longitudinal direction, or approximately 90% as large as the diameter of the hooking rod215A. Gap G may be approximately 10% to 200% of the diameter of the hooking rod215A depending on the curvature of the hollow tube210A through which the hooking rod215A must pass.

The space SP between first arm275A and second arm280A is sized to releasably capture suture S between first arm275A and second arm280A when hooking rod215A is retracted into hollow tube210A (FIGS. 105 and 106), but space SP is also sufficiently large so as to allow suture S to slide distally along first arm275A and second arm280A (FIGS. 103 and 104) when suture S engages circumferentially-extending edges255A of hollow tube210A. In other words, if suture S is not first captured directly in the hooking surface285A of first arm275A, when hooking rod215A is moved proximally, at the point where second arm280A closes, if suture S is trapped between first arm275A and second arm280A, circumferentially-extending edge255A of hollow tube210A stops suture S from moving proximally even as hooking rod215A continues to move proximally. Once hooking surface285A reaches circumferentially-extending edge255A of hollow tube210A, the space SP between first arm275A and second arm280A allows suture S to “slip” relative to hooking rod215A while suture S remains against circumferentially-extending edge255A of hollow tube210A, until hooking surface285A of first arm275A engages suture S and draws suture S into hollow tube210A (FIGS. 105-107). It has also been found that space SP is preferably at least as large as 50% of the diameter of suture S, and more preferably approximately 75-100% 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 passer205, the distal end of hollow tube210preferably comprises cutaway245, longitudinally-extending edges250and circumferentially-extending edge255as described above and shown inFIG. 69. Although with suture passer205A suture S is no longer clamped between hooking surface285A and cutaway245A, it has been found that providing cutaway245A is still beneficial in that it allows suture S to be drawn into hollow tube210A without being dislodged from hooking surface285A (i.e., when hooking rod285A pulls suture S in the proximal direction). It has also been found that if the distal end of hollow tube210A comprises a bevel cut (i.e., no cutaway245A), suture S can be prone to dislodge from hooking surface285A and/or the hook of first arm275A can catch on the end of hollow tube210A as the distal end of first arm275A passes by the bevel cut of hollow tube210A in a proximal direction.

In a preferred embodiment, the distal end of hooking rod215A has a circular cross-section (FIG. 108). In another embodiment, the distal end of first arm275A has a smaller width as compared to its height (FIG. 109). In this latter embodiment, the gap between the top and bottom surfaces of the distal end of first arm275A and the inner diameter of hollow tube210A is reduced, so as to further stabilize the distal end of first arm275A within hollow tube210A, thus reducing any movement of first arm285A within hollow tube210A and hence increasing the holding force of suture S. And in this embodiment, the gap between the sides of the distal end of first arm275A may be increased so as to enable suture S to slide more freely within hollow tube210A. In other words, the embodiment shown inFIG. 109may maintain or increase the holding force on suture S (as compared to the embodiment shown inFIG. 108), while improving the ability for suture S to slide freely within hollow tube210A.

FIGS. 100-112illustrate the suture passer205A delivering a suture loop to the far side of tissue T. InFIG. 100, suture is loaded onto the suture passer205A by placing the suture between first arm275A and second arm280A; in a preferred embodiment, suture S is placed against hooking surface285A. InFIGS. 101-107, hooking rod215A has been retracted proximally, carrying the suture S into the hollow tube210A. At this point, suture passer205A and suture S are ready to be passed through the tissue. Thereafter, inFIGS. 110-112, after suture passer205A and suture S have been passed through the tissue, the hooking rod215A is advanced distally and extended out of the hollow tube210A, 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 passer205A is moved free of the loop of suture S, hooking rod215A is retracted back into hollow tube210A, then the suture passer205A is pulled back out of the tissue T (not shown).

In one form of the invention, handle235A of suture passer205A (FIG. 92) comprises means for enabling the user to determine how far actuator320A has travelled. By way of example but not limitation, in one preferred form of the invention, handle235A comprises one or more detents such that when the actuator320A is repositioned, the user feels one or more tactile clicks, and/or hears one or more audible clicking sounds, during movement of the actuator320A between its most distal and proximal positions on handle235A.

In another form of the present invention, hooking rod215A comprises only a first arm275A (FIG. 113). In this embodiment, a pushing surface286A may serve to engage and help push the suture S when suture S is being moved distally within hollow tube210A. Pushing surface286A is spaced from hook of first arm275A by a gap similar to gap G as described above. In all other respects, first arm275A and hollow tube210A operate in the same manner as described above.

In yet another form of the present invention, first arm275A of hooking rod215A has a tissue-penetrating distal end (FIGS. 114 and 115). In this embodiment, hollow tube210A does not have a tissue-penetrating distal end. In all other respects, the invention as described above and shown inFIGS. 92-112apply (i.e., the construction and operation of first arm275A, second arm280A, hollow tube210A, etc.).

MODIFICATIONS