Needle Assembly and Method for Passing Suture

This invention relates generally to surgical instruments and procedures, and is directed more particularly to a needle assembly and a method for passing suture within the body.

Elongated rigid metal needles having pointed distal ends are used in many medical procedures to pass suture through tissue. In some cases the suture is attached to the needle by passing the suture through an eyelet formed in the proximal end of the needle. In other cases the suture is passed through an eyelet formed in the distal end of the needle. The rigid pointed end of the needle is required for penetrating the tissue which is to be sutured, but it is problematic when the needle must be passed safely by adjacent tissue which is not to be sutured.

By way of example, in a so-called "bladder neck suspension" procedure, the sharp needle must initially penetrate surface tissue, move safely past delicate abdominal organs, then puncture the tissues of the vaginal wall, pick up a piece of suture from a cavity below the vaginal wall and carry it back through the vaginal wall, and then safely carry the suture upward through the abdomen, without harming delicate abdominal organs, for connection to a bodily support structure (e.g., the pelvic bone).

Accordingly, there is a need for an improved needle assembly and an improved method for passing suture within the body, wherein the needle assembly provides a needle pointed end for penetration of tissue when desired, and has provision for shielding the needle pointed end when moving the needle pointed end past tissue which is not to be penetrated.

An object of the invention is therefore to provide an improved needle assembly including a needle distal end which is pointed and exposed for passing through tissue, and is shielded for passing the assembly safely past tissue which is not to be penetrated.

A further object of the invention is to provide an improved method for passing suture within the body, utilizing the improved needle assembly.

With the above and other objects in view, as will hereinafter appear, a feature of the present invention is the provision of a needle assembly for passing suture within the body. The assembly comprises a rigid needle having a proximal end and a pointed distal end, and an opening in the distal end extending through the needle for retaining a suture therein; a stop element positioned on the needle proximate to, and spaced from, the proximal end of the needle; a sheath having a lengthwise bore therethrough for slidably retaining the needle; and a lock member engageable with the needle stop element to prevent distal movement of the needle in the sheath bore. The needle distal end is movable to an exposed position for passing the assembly through tissue, and is movable to a shielded position within the sheath for passing the assembly safely past tissue which is not to be penetrated.

In accordance with another feature of the invention, there is provided a method for passing suture within the body, the method comprising the steps of: (1) providing a needle assembly comprising an elongated rigid needle having a proximal end and a pointed distal end, and an opening in the distal end extending through the needle for retaining a suture therein; a stop element positioned on the needle proximate to, and spaced from, the proximal end of the needle; a sheath having a lengthwise bore therethrough for slidably retaining the needle; and a lock member engageable with the needle stop element to prevent distal movement of the needle in the sheath bore; (2) positioning the needle proximally in the sheath so as to cause the needle distal end to be located in the sheath distal end, and engaging the lock member with the stop member so as to prevent distal movement of the needle in the sheath; (3) advancing the assembly within the body until the distal end of the sheath is adjacent to a piece of tissue through which a suture is to be passed; (4) disengaging the lock member from the stop element and moving the needle distally until the stop element engages the sheath, so as to cause the needle distal end to extend from the distal end of the sheath; (5) advancing the assembly through the piece of tissue until the needle exits the far side of the piece of tissue; (6) passing a suture through the opening in the needle distal end; (7) drawing the assembly and the suture back through the piece of tissue; and (8) disengaging the suture from the needle.

In accordance with a further feature of the invention, there is provided a method for passing suture within the body, the method comprising the step of providing a needle assembly comprising an elongated rigid needle having a proximal end and a pointed distal end, and an opening in the distal end extending through the needle for retaining a suture therein; a stop element positioned on the needle proximate to, and spaced from, the proximal end of the needle; a sheath having a lengthwise bore therethrough for slidably retaining the needle; and a lock member engageable with the needle stop element to prevent distal movement of the needle in the sheath bore. The method includes the further steps of disengaging the lock member from the stop element and moving the needle distally until the stop element engages a proximal end of the sheath, so as to cause the needle distal end to extend from a distal end of the sheath; advancing the assembly through a first piece of tissue at a first location; and drawing the needle proximally in the sheath so as to cause the needle distal end to re-enter the sheath distal end, and engaging the lock member with the stop element to prevent distal movement of the needle in the sheath. Other steps include advancing the assembly within the body until the distal end of the sheath is adjacent to a second piece of tissue, at a second location, through which suture is to be passed; disengaging the lock member from the stop element and moving the needle distally until the stop element engages the sheath, so as to cause the needle distal end to extend from the distal end of the sheath, and advancing the assembly through the second piece of tissue until the needle exits the far side of the second piece of tissue. A suture is then passed through the opening in the needle distal end, and the assembly and the suture are drawn back through the second piece of tissue, and the suture is disengaged from the needle. The above procedure may be repeated in the second piece of tissue, at a third location, so as to provide two suture free ends extending from the second piece of tissue.

In accordance with a further feature of the present invention, there is provided a needle assembly for passing suture within the body, the assembly comprising a rigid needle having a proximal end and a pointed distal end, and an opening in the distal end extending through the needle for retaining a suture therein; a sheath having a lengthwise bore therethrough for slidably retaining the needle; a lock member engageable with the sheath to prevent distal movement of the needle in the sheath bore; wherein the needle distal end is movable to an exposed position for passing the assembly through tissue, and is movable to a shielded position within the sheath for passing the assembly safely past tissue which is not to be penetrated.

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

FIG. 1 is a side elevational view of one form of needle assembly illustrative of an embodiment of the invention;

FIG. 2 is a side elevational view of a needle portion of the assembly of FIG. 1;

FIG. 3 is a perspective view of the needle of FIG. 2;

FIG. 4 is an end elevational view of the needle of FIG. 3;

FIG. 5 is a side elevational view of a sheath portion of the assembly of FIG. 1;

FIG. 6 is a sectional view taken along line 6--6 of FIG. 5;

FIG. 7 is an end elevational view of the sheath of FIG. 5;

FIG. 8 is an enlarged side elevational view of a portion of the sheath of FIG. 5;

FIG. 9 is an enlarged centerline sectional view of a portion of the sheath of FIG. 6;

FIG. 10 is a sectional view taken along the line 10--10 of FIG. 8;

FIGS. 11 and 12 are similar to FIG. 1, but show the lock member portion of the sheath, and the needle, in different operating positions;

FIGS. 13-25 and 25A-25C are diagrammatic depictions of a sequence of steps in part showing one method illustrative of an embodiment of the invention;

FIGS. 26-41 are in part centerline sectional, and in part side elevational, views of four alternative embodiments of sheath and needle distal ends, each embodiment being shown in four operating positions;

FIGS. 42 and 43 are in part centerline sectional, and in part side elevational, views of two additional embodiments of needle distal ends; and

FIGS. 44 and 45 are side elevational views of yet another form of needle assembly.

Referring first to FIG. 1, it will be seen that an illustrative needle assembly 50 comprises an elongated, rigid needle 52 (FIG. 2) having a proximal end 54 and a distal end 56. An opening, in the form of a round or linear aperture 58 (FIGS. 3, 4, and 26-37) or an elongated slot 58A (FIGS. 38-41) extends through distal end 56 of needle 52, widthwise of the needle, for retaining a suture S (FIGS. 28, 29, 32, 33, 36, 37, 40 and 41) therein. A stop element 64 (FIGS. 1 and 2), preferably in the form of a distal portion of a grip member 66, is positioned on needle 52.

Needle assembly 50 further includes a sheath 70 (FIGS. 1 and 5) having a lengthwise bore 72 (FIG. 6) extending therethrough for slidably receiving needle 52 (FIGS. 11 and 12). Sheath 70 preferably is formed out of a moderately flexible elastomeric or plastic material and is adapted to conform to the shape of rigid needle 52 (FIGS. 1, 11 and 12).

A lock member 74 (FIGS. 1, 11 and 12) is engageable by the needle stop element 64 (FIG. 1) in order to prevent distal movement of needle 52 in sheath bore 72. Lock member 74 may be a discrete element removable from sheath 70; or it may be fixed on the sheath, as by a hinge 76; or it may be formed integral with the sheath so as to be fixed thereon, with hinge 76 constituting a living hinge (FIGS. 8-10). Lock member 74 is movable to a position in which the lock member is interposed between needle stop element 64 and a proximal end 78 of sheath 70 (FIG. 1) so as to prevent distal movement of stop element 64, and thereby needle 52. Lock member 74 is further movable (FIG. 11) to another position (FIG. 12) so as to permit stop element 64 (and hence needle 52) to be moved distally toward proximal end 78 of sheath 70. Such movement enables the needle's distal end 56 and opening 58 (or opening 58A) to protrude clear of the distal end 80 of sheath 70 (FIG. 12).

The overall length L (FIG. 12) of needle 52 distally of stop element 64 exceeds the overall length L' (FIG. 12) of sheath 70 by a distance which is at least equal to a length L" (FIG. 12) of needle 52 as measured from distal end 56 thereof to a proximal extent of opening 58. The overall length L (FIG. 2) of needle 52 distally of stop element 64 is less than an overall length L'" (FIG. 1) of sheath 70 and lock member 74 combined. Thus, moving needle stop element 64 against sheath proximal end 78 causes needle distal end 56 and opening 58 to extend clear of sheath distal end 80 (FIG. 12), while holding needle stop element 64 against lock member 74 causes needle distal end 56 and opening 58 to remain within sheath 70 (FIG. 1).

To facilitate handling and operation of the assembly, needle proximal end 54 has fixed thereto the grip member 66 (FIG. 1). Sheath 70 is also provided with a grip portion 82 (FIG. 1) at proximal end 78 of sheath 70. The sheath's grip portion 82 has an outer profile which permits sheath 70 to be conveniently loaded onto needle 52 by gripping the sheath's grip portion 82 between thumb and forefinger and then pulling the sheath proximally back over the needle. The needle's grip member 66 has an outer profile which permits the needle 50 to be conveniently gripped by the user's thumb T (FIG. 1), index finger I, middle finger M, and ring finger R, while the sheath's lock member 74 has an outer profile which permits the lock member to be conveniently pressed away from needle 50 with the user's pinky finger P (see FIGS. 1, 11 and 12).

Sheath 70 is at least in part tapered along a portion of its length such that its distal end 80 is smaller in diameter than its proximal end 78.

The needle's aperture 58 (and slot 58A) is formed so as to allow the suture S to readily pass therethrough, as will be further described hereinbelow.

In one exemplary mode of operation, needle assembly 50 is prepared for use by positioning its constituent components in the arrangement shown in FIGS. 1 and 26, wherein the distal end 56 of needle 52 is disposed within sheath 70 and lock member 74 is disposed between needle stop element 64 and proximal end 78 of sheath 70. In other words, needle distal end 56 is safely nested within sheath 70. To prepare for entering through a body surface, lock member 74 is removed (e.g., with the user's pinky finger P) from its interposition between needle stop element 64 and sheath proximal end 78 (FIG. 11). This frees stop element 64, and thereby needle 52, for subsequent distal movement. At this point, needle assembly 50 is in the position shown in FIGS. 11 and 26.

By manipulation of needle grip member 66, an operator brings distal end 80 of sheath 70 to bear against a body surface B (FIG. 13). Using needle grip member 66, the operator then pushes needle 52 distally, causing needle distal end 56 to penetrate body surface B while distal end 80 of sheath 70 remains in engagement with body surface B (FIG. 14). Needle 52 continues to move distally until its stop element 64 engages proximal end 78 of sheath 70, at which point assembly 50 will be in the position shown in FIGS. 12, 15 and 27.

Continued advancement of needle 52 causes sheath 70 as well as needle 52 to move into body surface B (FIGS. 16). Advancement continues until needle 52 and sheath 70 pass completely through body surface B (FIG. 17). The operator then draws needle 52 back into sheath 70 (FIGS. 18 and 26), and then continues advancement of needle assembly 50 through the space Q within the body (FIGS. 18 and 19), towards and into engagement with the tissue V through which suture S is to be passed. In this respect it will be appreciated that, inasmuch as the needle's sharp tip will be safely shielded within sheath 70 as the needle assembly moves through space Q, the risk of the needle's sharp tip inadvertently damaging delicate tissues within space Q will be minimized.

Once the distal end of sheath 70 engages target tissue V (FIG. 19), the operator again manipulates lock member 74 (FIG. 11) so as to free needle 52 for distal movement. The user then advances needle 52 into tissue V, as illustrated in FIGS. 20 and 27. As this occurs, sheath 70 will initially remain engaged with the upper surface of tissue V while needle 52 penetrates into the tissue. Continued advancement of needle 52 will cause needle stop element 64 to engage sheath proximal end 78, whereby sheath 70 will also move into tissue V (FIG. 21). The needle assembly is then further advanced (FIG. 22) until the needle's distal end 56 and opening 58 clear tissue V and reside in a cavity C (FIG. 22) located on the far side of target tissue V. Suture S, introduced into cavity C independently of assembly 50, is then threaded through opening 58 in needle 52 (FIGS. 23 and 28) by means well known in the art. By way of example but not limitation, suture S might be threaded through needle opening 58 using small forceps while under visualization.

With suture S disposed in needle opening 58, needle 52 is withdrawn back into sheath 70 (FIGS. 24 and 29), and then needle assembly 50 is withdrawn from tissue V (FIG. 25) and, ultimately, body surface B. Suture S may be disengaged from needle assembly 50, either before or after the needle assembly is withdrawn through body surface B, leaving suture S extending from cavity C, through tissue V, through body space Q, and then, if desired, through body surface B.

The entire procedure may then be repeated again, at a different location, so as to pass another length of suture through tissue V.

By way of example but not limitation, after the two suture portions S' and S" (FIG. 25) have been passed through tissue V, portion S' can be pulled upward through tissue V, leaving just suture portion S" in the cavity C below tissue V (FIG. 25A). The needle assembly 50 can then be used to penetrate tissue V at another location so as to retrieve tissue portion S" (FIG. 25B) and pull it up through tissue V and across body space Q (FIG. 25C). By properly spacing the tissue penetration points, a loop of the suture S can extend beneath the tissue V such that, by attachment of the free ends of the suture S to a bodily support member (e.g., a bone), the tissue V may be suspended by the suture S.

The above-described procedure is believed to have particular utility in a bladder neck suspension procedure, wherein a needle is passed through the abdominal wall B, through abdominal space Q, through vaginal tissue V and then into the underlying cavity C. Suture is introduced into such cavity and, through known methods, is threaded through an eyelet in the needle. The needle is then withdrawn, drawing a portion of the suture upward therewith, so that it passes through vaginal tissue V. The foregoing procedure is then repeated at another location in the vaginal tissue V, such that pulling on the two free ends of the suture can elevate vaginal tissue V and, thereby, the patient's bladder neck. The above described assembly and method enable the bladder neck suspension procedure to be carried out without risk of injury to the patient's abdominal organs during transit of the needle point from the abdominal wall B to the vaginal tissue V.

More generally, however, the apparatus and method shown and described herein facilitate alternative modes of penetration in the course of any needle penetration activity, namely, a "hard" approach wherein the needle point is exposed for maximum penetration capability, and a "soft" approach for maximum safety in needle advancement.

As noted above, suture S is intended to be drawn into sheath 70 as needle assembly 50 is withdrawn back through tissue V, space Q and, if desired, body surface B. Preferably, but not necessarily, sheath 70 and needle 52 are sized so that suture S can slip relative to needle 52 even when the needle is retracted back into sheath 70 (i.e., when the assembly is in the position shown in FIG. 29).

In FIGS. 30-41, there are shown alternative embodiments of sheath 70, bore 72 and needle openings 58 (and 58A), all permitting slippage of suture S through opening 58 (and 58A) even when needle 52 is in its retracted position within sheath 70.

For example, in FIGS. 30-33, there is shown the bore 72 having an enlarged distal portion 90 which provides ample room around the needle distal end 56 and suture S, as shown in FIG. 33, to permit suture S to readily slip through opening 58, and a relatively confined portion 91 of bore 72 for support of needle 52.

In FIGS. 34-37, there is shown an embodiment in which sheath 70 is provided with axially-extending slots 92 through which suture S extends and can easily slip therethrough, thereby ensuring freedom of suture S to slip through opening 58, shown particularly in FIG. 37.

In FIGS. 38-41, there is shown an embodiment in which sheath 70 is provided with opposed apertures 94 and needle 52 is provided with the elongated slot 58A which can be aligned with the apertures 94 when the needle is extended (FIG. 40) for insertion of suture S, and which remains aligned with apertures 94 when the needle is retracted (FIG. 41), thereby permitting the suture to slip through opening 58A regardless of the position of needle 52 relative to sheath 70.

FIG. 42 illustrates yet another form of needle assembly. In this arrangement, needle 52 is provided with an opening 58B which is in the form of a hole 95 and a side opening 96 which communicates with the hole.

FIG. 43 illustrates still another form of needle assembly. In this construction, needle 52 is provided with an opening 58C which is configured so that the distal end of needle 52 comprises a crochet hook.

FIGS. 44 and 45 illustrate yet another form of needle assembly. In this construction, a lock member 96 is pivotally connected to grip member 66, whereby (i) lock member 96 can engage the proximal end 78 of sheath 70 (FIG. 44) so as to prevent distal movement of the needle within sheath bore 72, and (ii) lock member 96 can be disengaged from the proximal end 78 of sheath 70 (FIG. 45) so as to permit distal movement of the needle within sheath bore 72. A spring 97 may be provided to bias lock member 96 into the position shown in FIG. 44.

There is thus provided an improved needle assembly and method for passing suture within the body and providing to an operator an election between advancing the assembly through body portions in a mode providing maximum tissue penetration capability and a mode providing maximum safety to internal organs and tissue.

It is to be understood that the present invention is by no means limited to the particular construction and method steps herein disclosed and/or shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.