US20100324575A1 - Surgical repair kit and its method of use - Google Patents

Abstract

A suture passer comprises a longitudinally extending hollow cannula having a central passage slidingly receivable of a surgical suture; a manually graspable handle connected to the hollow cannula for manipulation thereof, the handle having an upper surface; first guide means, connected to the upper surface of the handle, proximate a distal end of the handle for releasably, guidingly, holding the surgical suture; second guide means, connected to the upper surface of the handle, proximate to the first guide means, for releasably, guidingly, holding the surgical suture. The suture passer can be provided in a kit, for use in the suturing of internal tissue, along with a cannula bender, various hollow surgical needles and surgical suture material. The suture passer finds particular use in the suturing of internal tissues which are at least partially accessible through a body cavity, e.g. arthroscopic surgery.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of the following, which are incorporated herein by reference:
• This application is a continuation of pending U.S. patent application Ser. No. 11/523,722 filed 19 Sep. 2006, which carries Applicants' docket no. MIT-53 CON 6, and is entitled SURGICAL REPAIR KIT AND ITS METHOD which is a continuation of issued prior U.S. patent application Ser. No. 09/811,953 filed 19 Mar. 2001, now U.S. Pat. No. 7,108,700, which is a continuation of prior U.S. application Ser. No. 09/111,237, filed on 7 Jul. 1998, now abandoned, which is a continuation of U.S. application Ser. No. 08/727,027, filed 8 Oct. 1996, now U.S. Pat. No. 5,776,151, which is a continuation of issued prior U.S. application Ser. No. 08/234,840, filed 24 Apr. 1994, now U.S. Pat. No. 5,562,683, which is a continuation-in-part of issued prior U.S. application Ser. No. 08/090,651, filed on 12 Jul. 1993, now U.S. Pat. No. 5,562,687.
• The following is incorporated herein by reference:
• Issued prior U.S. application Ser. No. 09/400,162 filed 21 Sep. 1999, now U.S. Pat. No. 6,629,984.
BACKGROUND OF THE INVENTION
• 1. The Field of the Invention
• The present invention relates to medical devices for performing surgery and a surgical repair kit containing the same. More particularly, the present invention is directed to a surgical repair kit useful for performing arthroscopic meniscal repairs and other surgical procedures.
• 2. The Relevant Technology
• Menisci are tough rubbery “C” shaped cartilage cushions that are attached by ligaments to the top (plateau) of the tibia. They prevent the surfaces of the tibia and femur from grinding against each other and act as the shock absorbers in the knee.
• Meniscal tears are a common problem in the United States, especially among amateur and professional athletes. While menisci are also located in the shoulder, the most common meniscus injury occurs in the knee. There are two menisci in each knee. Each year, tens of thousands of people suffer meniscal tears, particularly in or at the site of one or both knees. If these tears are not repaired, there may be a progressive deterioration of the cartilage, leading to the painful rubbing and wearing of bones which had previously been covered by cartilage. This, in turn, leads to inflammatory synovitis, arthritis and other debilitating ailments. Consequently there are at least 30,000 to 40,000 meniscal excisions or repairs to the shoulder and the knee performed each year.
• Men and women between the ages of 18 and 45 experience the majority of meniscal tears, usually during athletic activity, such as when twisting, cutting, pivoting, decelerating or when being tackled. When torn, the meniscus may have a longitudinal, horizontal or radial (“parrot beak”) tear.
• The damaged meniscus may be diagnosed with the assistance or use of magnetic resonance imaging (MRI) and/or an arthroscopic examination. Arthroscopy enables a surgeon to look into the joint using a miniature video camera. In many cases, torn fragments of the meniscus are removed arthroscopically. In other cases, a small tear at the periphery of the meniscus with a very swollen knee joint may be treated by draining the joint, temporarily restricting the use of the knee, and slowly having the patient begin rehabilitative exercises.
• However, in still other cases, the tears in the meniscus do require surgical repair, normally by sewing the torn sections of the meniscus together. The use of the arthroscope greatly aids in the surgical repair of the meniscus by allowing the surgeon to better visualize the small areas between which the torn meniscus lies. The arthroscope enables the surgeon to visualize the interior of the joint and to perform surgery through small puncture holes without having to open the joint as has been done in the past.
• A number of surgical tools have been developed to assist in suturing, and in particular the suturing of the meniscus.
• U.S. Pat. No. 2,808,055 (Thayer) discloses a surgical stitching instrument which accommodates a bobbin of suture material and includes means to feed the suture material to a needle. A slidable thread moving member is provided for advancing the suture material through the needle.
• U.S. Pat. No. 3,476,114 (Shannon, et al.) discloses a ligating implement comprising an elongated instrument through which a ligature passes to form a loop at one end with a disc. The disc provides a means whereby the loop may be drawn tight above a severed vessel of the like.
• U.S. Pat. No. 3,476,115 (Graeff, et al.) discloses a ligating implement as in Shannon, et al., and includes severing means to prevent overstressing of the locking disc during tightening of the noose.
• U.S. Pat. No. 4,493,323 (Albright, et al.) discloses a suturing device and a method for its use in arthroscopic surgery. The suturing device comprises an elongated tube and plunger which are used to hold and advance a pair of needles united by a length of suture material.
• U.S. Pat. No. 4,641,652 (Hutterer, et al.) discloses an applicator for tying sewing threads which comprises a helical tubular coil connected to a shaft having an axial passage. A catcher loop is extendable through the shaft to catch a sewing thread inserted manually into the coil passage.
• U.S. Pat. No. 4,935,027 (Yoon) discloses surgical instruments and methods for effecting suturing of tissue controlled from a position remote from the suture site. The invention provides for the continuous feeding of suture material through opposed forcep jaw members between which the tissue segments are interposed.
• U.S. Pat. No. 5,112,308 (Olsen, et al.) discloses a medical device for and a method of endoscopic surgery. The device includes a dilator having a tapered end and a central passage which accommodates a guide wire for directing the dilator. This device does not include any means whereby the guide wire may be secured to the dilator or otherwise manipulated in conjunction therewith.
• U.S. Pat. No. 4,779,616 (Johnson) discloses a method for snagging an end of a surgical suture during arthroscopic surgery, comprising deploying a distal end of a cylindrical cannula adjacent to the end of the suture within the body and passing a resilient loop through the cannula to snag the suture.
• U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498 (Caspari, et al.) discloses a suturing instrument and method of use in arthroscopic surgery. The suturing instrument includes a hollow needle for penetrating tissue to be sutured within the body while the tissue is clamped between relatively movable jaws and a suture feed mechanism for feeding suture material through the hollow needle. The jaws can be opened and the suturing instrument withdrawn from the body, pulling the free end segment of the suture material with the instrument.
SUMMARY OF THE INVENTION
• It is an object of the present invention to provide a surgical repair kit. In particular, it is an object of the present invention to provide a surgical repair kit which is particularly suited for the repair of torn menisci.
• It is still yet another object of the present invention to provide a suture passer having means for positioning of the suture.
• It is still yet another object of the present invention to provide a parallel needle guide to allow for an easier and more successful placement of a second needle in close proximity to the first needle that has been previously inserted in the area of a tissue tear.
• Another object of the present invention is to provide a modular suture passer assembly of the sort comprising a handle and a cannula, wherein the handle is adapted to releasably and lockingly hold the cannula for manipulation by a surgeon so that a length of suture may be passed through tissue.
• Still another object of the present invention is to provide a surgical kit for use in passing a length of suture through tissue, wherein the kit comprises a handle and various interchangeable cannulas, with each cannula being adapted to be releasably and lockingly held by the handle during a surgical procedure.
• Yet another object of the present invention is to provide a surgical cannula having a sharp distal tip which is adapted to pierce tissue.
• And another object of the present invention is to provide a surgical cannula having a sharp distal tip which is adapted to pierce tissue while at least one strand of suture extends out of the cannula's sharp distal tip, wherein the sharp distal tip of the cannula is specially configured so as to minimize the possibility of damaging or severing the suture during the tissue piercing operation.
• Still another object of the present invention is to provide a modular suture passer assembly which is relatively simple to manufacture and relatively easy to use.
• Yet another object of the present invention is to provide a new method for passing suture through tissue.
• While the present invention is primarily concerned with the repair of torn menisci, the repair kit, the parallel needle guide, and the suture passer may be used in other surgical procedures, e.g. for suturing internal tissue at least partially accessible through a body cavity.
• The suture passer of the invention comprises a longitudinally-extending hollow cannula having a central passage slidingly receivable of a surgical suture and a manually graspable handle connected to the hollow cannula for manipulation thereof. The suture passer has a first guide means connected to an upper surface of the handle, proximate to a distal end of the handle for releasably, guidingly holding the surgical suture, and a second guide means connected to the upper surface of the handle, proximal to the first guide means for releasably, guidingly holding the surgical suture.
• In one embodiment of the invention, the hollow cannula is connected to the upper surface of the handle and the hollow cannula terminates at a rearward opening between the first and second guide means. In another embodiment of the invention, the hollow cannula is received within a bore formed in the handle, with the bore terminating at an opening in the upper surface of the handle between the first and second guide means.
• The guide means may be loops which are either parallel or transverse to the longitudinally-extending hollow cannula. In an alternative embodiment, the second guide means may consist of a plurality of bent fingers lying in parallel planes.
• The guide means serve as means about which the suture is passed so it may be manipulated longitudinally with respect to the cannula. The diameter of the central passage of the cannula is such that the tip of a spinal epidural or similar needle into which the suture is directed may fit into the cannula and is large enough to allow the sliding passage of two surgical sutures (i.e. the two limbs of a single surgical suture). In the method of use, the suture passer is used in surgical manipulations, and in particular meniscal repairs or other arthroscopic procedures to direct a suture within a joint space with a greater degree of precision than available by current methods.
• When the two limbs of a surgical suture are within the cannula, the guide means function to separate the two limbs. Separation of the limbs of the surgical suture allows independent manipulation of the suture limbs. Digital manipulation of the surgical suture between the first and second guide means causes longitudinal passage of one limb of the surgical suture within the cannula, i.e. friction between the digit and the said suture will cause the said suture to slide along the top surface of the handle, into or out of the cannula, when manipulated digitally.
• In one surgical repair kit formed in accordance with the present invention, the kit comprises a suture passer, as previously described, at least two surgical needles of predetermined length and at least one stylet for each surgical needle. Preferably, the surgical repair kit includes three surgical needles, with one of the surgical needles having a length greater than that of the other needles.
• In one preferred embodiment, the suture passer is provided with a metal cannula, and the surgical repair kit includes a cannula bender for bending the metal cannula in a desired manner. The cannula bender comprises a base and a pair of upwardly stepped symmetrical bolsters positioned on top of the base allowing the cannula to be bent to the right or to the left, each step of each bolster having a predetermined radius of curvature wherein the radius of curvature of each step is smaller than the radius of curvature of the step immediately below.
• Additionally, in one surgical repair kit formed in accordance with the present invention, the kit may further include a parallel needle guide for guiding the surgical needles for desired placement relative to each other. The parallel needle guide comprises at least three longitudinally extending, hollow tube-shaped units longitudinally adhered to each other, in a plane, parallel to one another, each of the tube-shaped units slidingly receivable of a surgical needle therethrough.
• The present invention also provides methods for the suturing of internal tissue which is at least partially accessible through a body cavity.
• A first method comprises the steps of:
• (A) providing at least one suture having a first limb and a second limb;
• (B) providing a suture passer comprising a longitudinally extending hollow cannula having a distal opening, a proximal opening and a central passage slidingly receivable of a surgical suture;
• (C) introducing the distal end of the cannula into a body cavity at least partially accessing internal tissue to be sutured:
• (D) identifying a first insertion site for passing a first limb of a suture through the internal tissue to be sutured;
• (E) inserting a first hollow needle through the first insertion site, the hollow needle extending from outside the body through the first insertion site into the body cavity;
• (F) identifying a second insertion site for passing a second limb of the suture through the internal tissue to be sutured;
• (G) inserting a second hollow needle through the second insertion site, the hollow needle extending from outside the body through the second insertion site into the body cavity;
• (H) passing the second limb of the suture through the first hollow needle into the distal opening of the cannula until it exits the proximal opening of the cannula;
• (I) feeding the second limb of the suture back into the cannula through the proximal opening;
• (J) passing the second limb of the suture through the hollow cannula into the second hollow needle until it exits the needle external of the body;
• (K) drawing the suture through the cannula into the body cavity;
• (L) removing the first and second needles by drawing them outwardly of the body cavity;
• (M) tying the limbs of the suture; and
• (N) repeating steps (D)-(M) until a surgically sufficient number of sutures have been tied.
• A second method comprises the steps of:
• providing at least one suture having a first limb and a second limb;
• (B) providing a suture passer comprising a longitudinally-extending hollow cannula having a distal opening, a proximal opening and a central passage slidingly receivable of a surgical suture;
• (C) loading the suture passer with a surgical suture such that an end of the first limb of the suture and an end of the second limb of the suture each protrude from the distal end of the cannula;
• (D) introducing the distal end of the cannula into a body cavity at least partially accessing internal tissue to be sutured;
• (E) identifying a first insertion site for passing the first limb of the suture through the internal tissue to be sutured;
• (F) inserting a first hollow needle through the first insertion site, the hollow needle extending from outside the body through the first insertion site into the body cavity;
• (G) identifying a second insertion site for passing a second limb of the suture through the internal tissue to be sutured:
• (H) inserting a second hollow needle through the second insertion site, the hollow needle extending from outside of the body through the second insertion site into the body cavity;
• (I) introducing the end of the first limb of the suture into the first hollow needle until it exits the first hollow needle outside the body;
• (J) introducing the end of the second limb of the suture into the second hollow needle until it exits the second hollow needle outside the body;
• (K) drawing the suture through the cannula into the body cavity;
• (L) removing the first and second hollow needles by drawing them outwardly of the body cavity;
• (M) tying the limbs of the suture; and
• (N) repeating steps (C)-(M) until a surgically sufficient number of sutures have been tied.
• In a further modification of the invention, the suture passer may be formed in a modular fashion so that a variety of different cannulas can be attached to its handle. These cannulas may be blunt or sharply pointed, and they may be straight or curved, as required for a particular surgical procedure. In this form of the invention, the suture passer's handle includes a female lock portion which is configured to receive and lockingly hold a cannula which is provided with a corresponding male lock portion.
• In a preferred form of the modular suture passer, each of the interchangeable cannulas is provided with a radial fin which is attached to the cannula adjacent to the cannula's proximal end. This fin includes a main portion and a tab portion. The tab portion of the fin extends proximally from the main portion of the fin. The tab portion of the fin includes an upper tab projection defining an upper, distally facing tab shoulder and a lower tab projection defining a lower, distally facing tab shoulder. The tab portion's upper and lower tab projections are located between the main portion of the fin and the proximal end of the tab portion. The tab portion's upper and lower tab shoulders are aligned with one another.
• The modular handle includes first and second suture guide means generally of the sort disclosed above.
• The modular handle also comprises a first bore which extends proximally and axially into the handle from the distal end thereof. The first bore includes a stop at its proximal end. The first bore is sized and positioned so that it can receive the proximal portion of a selected cannula, with the proximal end of the cannula's central lumen opening onto the upper surface of the handle between the first and second guide means when the cannula's proximal end is in engagement with the first bore's stop. A slot extends proximally and axially into the handle from the distal end thereof. The slot communicates with the handle's first bore and is sized to receive the main portion of the fin of a cannula when that cannula is mounted to the handle.
• A cavity is formed in the handle immediately proximal to the slot. This cavity is sized to receive the tab portion of a cannula when that cannula is mounted to the handle. An upper sidewall projection extends inwardly into the cavity from one of the sidewalls of the cavity, and a lower sidewall projection extends inwardly into the cavity from the same sidewall of the cavity. The upper sidewall projection defines an upper, proximally facing sidewall shoulder, and the lower sidewall projection defines a lower, proximally facing sidewall shoulder. The upper and lower sidewall shoulders are aligned with one another. The upper and lower sidewall projections are located such that as the tab portion of a given cannula enters the handle's cavity, the cannula's upper and lower tab projections will snap over and lockingly engage the handle's upper and lower sidewall projections when the cannula is fully inserted into the handle's first bore. In particular, when the assembly is in this locked condition, the cannula's distally facing upper tab shoulder will engage the handle's proximally facing upper sidewall shoulder, and the cannula's distally facing lower tab shoulder will engage the handle's proximally facing lower sidewall shoulder.
• When a given cannula has been mounted to the handle in the foregoing manner, rotational movement of the cannula relative to the handle is precluded by the engagement of the cannula's main fin portion with the sidewalls of the handle's slot. In addition, axial movement of the cannula relative to the handle is precluded (i) in the proximal direction by the engagement of the proximal end of the cannula with the stop located at the proximal end of the handle's first bore, and (ii) in the distal direction by the engagement of the cannula's two distally facing tab shoulders with the handle's two proximally facing sidewall shoulders.
• The handle of the modular suture passer also includes means for releasing a cannula from its locking engagement with the handle. More particularly, when a given cannula has been mounted to the handle in the foregoing manner, the proximalmost portion of the cannula's tab portion will extend proximally into a second bore formed in the handle. The second bore extends axially through the handle, from the proximal end of the handle's cavity to the proximal end of the handle. A release rod is positioned within the second bore for reciprocal movement therein, between (i) a proximalmost position in which the release rod is withdrawn from engagement with a cannula mounted to the handle, and (ii) a distalmost position in which the release rod is in engagement with a cannula mounted to the handle. Spring means are provided for yieldably biasing the release rod into its proximalmost position. The release rod has a bevelled distal end terminating a drive surface. A cannula is dismounted from the handle by urging the release rod from its proximalmost position to its distalmost position. As the release rod begins to move from its proximalmost position to its distalmost position, the rod's bevelled distal end will first engage the proximal end of the cannula's tab portion and deflect the tab portion laterally, whereby the cannula's two distally facing tab shoulders will be disengaged from the handle's two proximally facing sidewall shoulders. Thereafter, as the release rod continues to move from its proximalmost position to its distalmost position, the release rod's drive surface will engage the proximal end of the cannula's tab portion, whereby the entire cannula will be driven distally so that the cannula's two tab projections will clear the handle's two sidewall projections. This will unlock the cannula from the handle. The cannula may thereafter be manually withdrawn from the handle by pulling the cannula in a distal direction.
BRIEF DESCRIPTION OF THE DRAWINGS
• VariousFIG. 1 is a side view of the suture passer.
• FIG. 2 is a top view of another embodiment of the suture passer.
• FIG. 3 is a side view of the suture passer ofFIG. 2.
• FIG. 4 is a frontal view of the handle of the embodiment of the surgical suture passer ofFIG. 3.
• FIG. 5 is a cross section of the handle of the surgical suture passer.
• FIG. 6 is a side view of another embodiment of the surgical suture passer.
• FIG. 7A is a side view andFIG. 7B is a top view of another embodiment of the surgical suture passer.
• FIG. 8A is an enlarged side view of a tip of a spinal needle andFIG. 8B is an enlarged side view of a tip of an epidural needle.
• FIG. 9 is a side view of a parallel needle guide.
• FIG. 10 is a frontal view of a parallel needle guide.
• FIG. 11 is a side section view of a needle containing a stylet.
• FIG. 12 is a frontal view of a cannula bender.
• FIG. 13 is a frontal view illustrating the use of the cannula bender.
• FIGS. 14-FIG.26 are cross-sectional top views at various stages of an operation where the middle third of the meniscus is being repaired.
• FIG. 27A,FIG. 27B, andFIG. 28-31 are cross-sectional top views at various stages of an operation where the posterior region of the meniscus is being repaired.
• FIG. 32 is a left side view of a modular suture passer formed in accordance with the present invention.
• FIG. 33 is a right side view of the modular suture passer shown inFIG. 32.
• FIG. 34 is a top view of the modular suture passer shown inFIG. 32.
• FIG. 35 is a bottom view, with portions broken away, of the modular suture passer shown inFIG. 32.
• FIG. 36 is a left side view similar toFIG. 32, except that the modular suture passer's handle is shown in section so as to reveal how the cannula is in locking engagement with the handle.
• FIG. 37 is a bottom view similar toFIG. 35, except that the modular suture passer's handle is shown in section so as to reveal how the cannula is in locking engagement with the handle.
• FIG. 37A is an enlarged bottom view showing selected portions ofFIG. 37 in greater detail.
• FIG. 38 is a left side view similar toFIG. 36, except that the cannula is shown released from its locking engagement with the handle, with the handle's release rod having moved from its proximalmost position to its distalmost position.
• FIG. 39 is a bottom view similar toFIG. 37, except that the cannula is shown released from its locking engagement with the handle, with the handle's release rod having moved from its proximalmost position to its distalmost position.
• FIG. 39A is an enlarged bottom view showing selected portions ofFIG. 39 in greater detail.
• FIG. 40 is an enlarged left side view, partially cut away, of a cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 41 is a rear view of the cannula shown inFIG. 40.
• FIG. 42 is a top view, partially cut away, of the cannula shown inFIG. 40.
• FIG. 43 is an enlarged top view of the pointed distal end of the cannula shown inFIG. 40.
• FIG. 44 is an enlarged left side view, partially cut away, of another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 45 is an enlarged left side view, partially cut away, of still another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 46 is an enlarged left side view, partially cut away, of yet another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 47 is an enlarged left side view, partially cut away, of still another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 48 is an enlarged left side view, partially cut away, of yet another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 49 is an enlarged left side view, partially cut away, of still another cannula suitable for use with the modular suture passer shown inFIGS. 32-39.
• FIG. 50 is an illustrative side view showing the modular suture passer ofFIGS. 32-39 adjacent to a piece of tissue, wherein a length of suture extends through the suture passer's cannula, and further wherein the suture end extending out of the distal end of the cannula engages the handle's distal suture guide, and the suture end extending out of the proximal end of the cannula engages the handle's proximal suture guide.
• FIG. 51 is an illustrative side view similar to that ofFIG. 50, except that the distal end of the cannula has been inserted through the piece of tissue, carrying the length of suture with it.
• FIG. 52 is an illustrative side view similar to that ofFIG. 51, except that the cannula has been withdrawn from the piece of tissue, leaving a loop of suture extending through the tissue, with the suture end extending from the distal end of the cannula having been disengaged from the handle's distal suture guide.
• FIGS. 53-55 illustrate how a simple stitch can be established across two pieces of tissue using the present invention.
• FIGS. 56-58 illustrate how a suture loop can be passed across two pieces of tissue using the present invention.
• FIGS. 59-61 illustrate two different ways a folded suture loop can be passed across two pieces of tissue using the present invention.
• FIGS. 62-64 illustrate how a simple stitch can be converted to a mattress stitch with a suture loop using the present invention. embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIGS. 1-7 illustrate the meniscal suture passer1, used for the passage of a suture in a confined area of the body during surgery. The suture passer1 comprises a longitudinally extendinghollow cannula2 having a central passage slidingly receivable of a surgical suture, and a manuallygraspable handle3 connected to thehollow cannula2 for manipulation thereof. A first guide means is connected to the upper surface of thehandle3 for releasably, guidingly holding the surgical suture. A second guide means for guidingly holding the suture, is also connected to the upper surface of thehandle3. The second guide means is proximal to the first guide means. The suture passer1 inFIGS. 1-6 comprises acannula2, ahandle3, arearward opening4 near the distal end of thehandle3, adistal loop5, and aproximal loop6. Thedistal loop5 serves as the first guide means, and theproximal loop6 serves as the second guide means.Distal loop5 preferably comprises a single turn open wire loop having a first axis of rotation of the loop andproximal loop6 is preferably a11/2 pigtail open wire loop having a second axis of rotation of the loop. The loops are preferably parallel to one another. In one embodiment, thewire loops5 and6 are preferably perpendicular to thehandle3 with the first axis of rotation and the second axis of rotation transverse to said longitudinally extendinghollow cannula2. In another embodiment, the axes of rotation ofloops5 and6 are parallel to thelongitudinally extending cannula3. Near the distal end of the handle there is anopening4 which leads from thehandle3 to thecannula2. The handle is preferably provided with gripping means and is preferably knurled at7, so that the surgeon has a better grip on the suture passer1.
• Thecannula2 may be attached and enter through an opening at theconcentric center8 of thehandle3 as shown inFIG. 1. Thehollow cannula2 is received within a bore formed in thehandle3 with thebore8 terminating at anopening4 in theupper surface9 of thehandle3 intermediate the first and second guide means. In an alternative embodiment the cannula may be connected to theupper surface9 of thehandle3, as shown inFIG. 3. In this embodiment of the invention, there is no opening into or through thehandle3. Instead, thehollow cannula2 terminates at arearward opening10 between the first and second guide means directly on top of thehandle3. Additionally, in the embodiment ofFIG. 1, the handle of the suture passer is rounded, whereas in the embodiment ofFIGS. 3 and 4, the suture passer handle3 is flattened on the side upon which theproximal end10 of thecannula2 resides. Additionally, in the embodiment ofFIG. 3, thedistal loop5 resides on thecannula2 just prior to theproximal opening4 of thecannula2.
• The central passage of the cannula should have a diameter large enough to allow sliding passage of two surgical sutures therethrough. The distal opening11 of the cannula should also have a diameter large enough to allow engagement with the tip of the spinal or epidural needle for the purpose of passage of the suture between the cannula and the needle.
• In the embodiment ofFIG. 1, thecannula2 from its distal opening11 to the point at which it enters the handle ranges in length from about 6.0 cm to about 20.0 cm, and more preferable is about 12.0 cm in length. The opening of thecannula2 is preferably from about 0.08 cm to about 0.32 cm in width, and more preferable is about 0.16 cm in width. The wall of thecannula2 is preferably from about 0.01 cm to about 0.05 cm in thickness, and more preferably is about 0.0254 cm in thickness. The handle preferably has a width ranging from about 0.64 cm to about 1.28 cm, and more preferably is about 0.96 cm in width.
• The wire of the wire loops as shown inFIG. 5 ranges from about 0.10 to about 0.14 cm in diameter “a” and is preferably attached to the handle by a mountingstructure12 about 0.1 to about 0.4 cm in height “h”.
• In the embodiment of the invention illustrated inFIG. 6, the suture passer1 is similar to the invention illustrated inFIG. 3; however, thecannula2 is flush with the flattened surface of the handle1 bearing thewire loops5 and6. Asegmented piece13 upon which thedistal loop5 resides attaches thecannula2 to thehandle3. Theproximal opening10 of the cannula opens on the proximal side of thesegmented piece13.
• In all of the embodiments of the meniscus suture passer1, theproximal loop6 may be fitted anywhere along the length of the handle. However, it is preferable that theproximal loop6 be fitted about halfway between the ends of the handle of the suture passer.
• In yet another embodiment of the invention, shown inFIG. 7A andFIG. 7B, the first guide means comprises a single turn open loop lying in a first plane, with the first plane disposed perpendicularly to the longitudinally extending hollow cannula, and a second guide means comprises a plurality of bent fingers lying in parallel planes. The planes are parallel to each other and are perpendicular to the longitudinally extending hollow cannula. The bent fingers may be alternately bent in opposite directions. As shown inFIGS. 7A and 7B, the second guide means may have 3bent fingers14,15,16.
• The suture passer1 may be made out of either plastic or metal, or a combination thereof, with the handle, loops, or cannula being plastic, metal or any combination thereof. The cannula of the meniscal suture passer may be semi-rigid. The cannula should be rigid enough to stabilize the inner tear of the meniscus during the insertion of the spinal or epidural needle. Additionally, if made of plastic, the cannula should be malleable enough that it can be bent by hand without the need of a special bender. After the cannula is bent it should not spring back. Because of its malleable characteristics, the plastic material is less likely to damage the articular surface. If the suture passer is entirely made out of plastic, the entire suture passer device can be injection molded as a single unit. If the handle is made out of plastic material, the loop or the finger projections may be molded as an integral part of the handle.
• If the suture passer is made out of metals, however, the loops may be screwed, riveted, or soldered onto the handle of the suture passer.
• Frequently, surgical instruments and suturing devices must be adaptable to the environment or conditions in which they are being used. More specifically, because of the location of the menisci in the shoulder and in the knee, or because there is limited space in that part of the body being repaired for the placement of surgical tools, especially during suturing, it is frequently advisable to adjust the shape of the cannula of the suture passer or to bend the needles being used during suturing the allow for the positioning of the instruments into or through the surgical incision to allow for maximum visibility on the part of the operating team and to avoid crowding of the incision area which would hinder the operating team.
• Preferably included in the surgical repair kit when the cannula is made out of metal is a cannula bender. The cannula bender may be used to bend the cannula without kinking the cannula.
• Thecannula bender30 shown inFIGS. 12 and 13 is designed to bend a cannula to a desired curvature. It is different from the existing tube or cannula benders in that it allows the cannula be bent to various radii of curvature. Thecannula bender30 can also bend the cannula in more than one plane.
• Thecannula bender30 consists of a base31 with an approximate diameter of from about 1.25 cm to about 8 cm, with a preferred diameter of about 3.8 cm. The base which is preferably curved, circular, or oval in shape, serves as a handle by which the cannula bender is grasped. The base31 may be knurled or striated to provide for a better grip.
• There are symmetrical curbed bolsters havingsteps33,34,35, and36 on top of the base. The stepped configuration provides thehigher steps34,35 with a smaller radius of curvature. The steps range from about 0.6 cm to about 4 cm in height, with a preferred height of about 1 cm. (Two steps are illustrated but more can be provided).
• Thecannula2 is bent against the bolsters33 or36 to create the desired curvature. If a greater degree of curvature is required the cannula may be bent against the higher bolsters34 or35 that have a smaller radius. The symmetry of the bolsters allows the cannula to be bent to the right or to the left without having to rotate the cannula bender. This allows for a faster, easier use of the cannula bender should the need arise during surgery.
• The cannula can be bent again in a different plane by rotating the cannula while maintaining the cannula bender in the same orientation. The pre-bent cannula can be contoured against the bolster in a second planes as long as the curvature is less than the height of the step of the bolster.
• The entire cannula does not have to be bent, if at all. The purpose of bending the cannula is for the convenience of the surgeon in passing the suture to and from the needle(s) to the suture passer, and to manipulate the suture passer, to each an area in the cavity or joint that would otherwise be inaccessible by a straight cannula.
• In addition to the suture passer device, the surgical repair kit also contains at least two and preferably three needles. These needles can be either epidural needles or spinal needles. It is preferred that the needles beepidural needles18, two of which are of the same length, e.g., about 3.5 inches in length, and one of which is longer, e.g. about 4.75 inches in length. It is also preferred that the needles be 18 gauge needles. As seen inFIG. 8A, aspinal needle17 has a bevelled tip which, during repair of the meniscus, may accidentally lacerate the articular cartilage. In contrast, as seen inFIG. 8B, theepidural needle18 has a Huber tip. With the epidural needle it is easier to advance the needle through tough tissue by using a twisting motion. The “rounded” tip of the epidural needle is less likely to lacerate the articular surface.
• The surgical repair kit preferably comes with at least two needles of the same length because the needle which is inserted first becomes blunt after several insertions. The insertion of the second, generally longer, epidural needle is easier with the use of theparallel needle guide19 as shown inFIGS. 9 and 10. (Longer and shorter needles are utilized to prevent thehubs29A of adjacent needles from interfering with one another by staggering the hub distance from the patient's body). The parallel needle guide allows for the proper alignment of the needles through which the suture will pass. The parallel needle guide is a series of at least three, and preferably four to five hollow tube shapedunits20 longitudinally adhered to each other one on top of the other in a parallel formation. The opening or diameter of each tube shaped unit should be large enough to allow for the passage of an 18 or 21 gauge needle to pass through. The parallel needle guide may be made out of plastic, paper or metal. The parallel needle guide may be from a mold, or the individual tubes may be individually formed and bonded to each other. Any method of forming the structure is acceptable.
• Additionally, there is at least one stylet typified bystylet29 shown inFIG. 11 in the surgical repair kit for each needle included in the repair kit. The stylet is kept in the needle until the needle is passed through the meniscus. This presents the needle(s) from being clogged with tissue and cartilage as it is pushed through the cartilage. A needle clogged with tissue will, of course, not allow the suture to be passed through the needle to the suture passer.
• A template (not shown) is preferably included in the surgical repair kit. This template, which may be printed on the back of the surgical repair kit container, may be printed on a paper guide inside the meniscal repair kit, or may be provided on, or as, a plastic guide. The template is used as a guide for the bending of the cannula.
• Each of the items included in the surgical repair kit is sterile. Additionally, each item in the surgical repair kit is preferably individually packaged in sterile plastic, paper, metal foil, or combinations thereof. The packaging should be easy to open, so that the contents thereof are not damaged or do not fall on the operating floor while opening. The content of the package and the packaging may be sterilized with ethylene oxide or by radiation, or any other conventional method for the sterilization of packaged elements.
• The surgical repair kit which includes the suture passer, at least two surgical needles of predetermined length, and at least one stylet for each needle, may also contain an optional third needle of greater length than the other two needles, the parallel needle guide, and a template. If the cannula is made of metal, a cannula bender may be included in the repair kit. While the repair kit may be used for any surgery, the repair kit is extremely useful in meniscal repair kit.
• In repairing the middle third of the meniscus, thearthroscope37 should enter through theipsilateral portal38 as shown inFIG. 14. The suture passer1 should enter through thecontralateral portal39. The epidural needle is loaded through the hole on one end of the needle guide using a one handed technique to avoid accidental puncture of the surgeon's opposite hand.
• There are three methods of identifying the insertion points for the needles.
• The first method is to view the meniscal tear with the arthroscope, with the synovial meniscal junction in view, and then advance the arthroscope to the synovial meniscal junction. The light from the arthroscope will transilluminate the skin. The point of insertion of the epidural needle should be slightly distal to this light.
• The second method of determining where to insert the needles is to view the meniscal tear and to keep the synovial meniscal junction in view. Palpate along the joint line with a tip of a finger or a meniscal probe. The area of maximal wall motion at the synovial meniscal junction indicates the point at which the epidural needle should be inserted.
• The third method is the easiest method in determining the needle insertion point, if the synovial meniscal junction is accessible to the suture passer. The tip of the suture passer is pushed against the synovial meniscal junction and the skin is palpated, with the finger. The area of the tip will indicate the approximate location where the needle should be inserted.
• The needles may be advanced with a twisting motion if difficulty is encountered in penetrating the tough meniscal tissue. As shown inFIG. 15, theinner rim40 of themeniscal tear41 may be buttressed with the tip of thecannula2 of the suture passer to stabilize it against the advancingneedle18.
• Using the parallel needle guide, two epidural needles are inserted through the guide and across the meniscal tear with the longepidural needle42 being inserted through the needle guide at a desired separation distance from the shorter needle (as shown inFIG. 16). This longer needle is inserted through the meniscal tissue, preferably behind the shorter needle. The stylets are removed from the needles. A suture is passed through the “first” needle. The tip of the cannula of the suture passer is introduced into the joint cavity through a small incision. The distal opening of the cannula is placed at or near the opening of the needle through which the suture has been passed. There are areas in the joint cavity, although visible through the arthroscope which are not accessible with a straight cannula. Consequently, prior to the introduction of the suture passer, the cannula of the suture passer may be bent on the cannula bender. The curbed cannula allows the surgeon to reach remote areas where the meniscus is being repaired.
• In a preferred method for passing the suture from the cannula to the needle, the needle, preferably an epidural needle with a Huber tip, engages the opening of the cannula (FIG. 17). The more posterior needle is advanced into the joint and the surgeon captures the tip of the needle with the tip of the cannula. For ease of passage, it is preferable that the cannula and needle meet at about a 15.degree.-20.degree. angle. The opening of the needle should be facing away from the apex of engagement between the cannula and the needle. The suture is passed directly from the cannula into the tip of the needle or vice versa.
• By careful manipulation, thesuture43 is fed through the needle and into the cannula. With the tip of the cannula and the needle securely engaged, the suture is fed (FIG. 18) into the hub of the needle until it exits the proximal end of the cannula at the handle of the suture passer. It is advisable to pull the suture three quarters of the way through. The suture is then looped onto the distal guide and is threaded back into the cannula. The suture is then engaged onto the proximal guide (FIG. 19).
• The first needle is removed, and with the two limbs of the suture held separately by the proximal and distal loops, one limb of the suture is advanced by sliding the suture with the index finger over the top surface of the handle so that the suture emerges from the tip of the cannula (FIG. 20). The suture, via the suture passer, is now fully controllable with one hand. The tip of the second needle and the tip of the cannula are brought into close proximity and the suture is passed from the loaded suture passer into the opening of the second needle and through the second needle. The suture is advanced until it exits from the hub of the second needle (FIG. 21). The second needle is partially removed so that the tip of the second needle is buried within the soft tissue44 (FIG. 22). The suture is disengaged from the guides on the handle of the suture passer.
• While grabbing both ends of the suture, the suture is pulled through the cannula into the joint45 (FIG. 23). With the second needle still in place, a stab incision is made along the shaft of the second needle down to the level of the joint capsule47 but not beyond (FIG. 24). The second needle is removed and the soft tissue is dissected all the way down to the joint capsule by spreading the soft tissue with a pair of small forceps48 (FIG. 25). The other limb of the suture is then retrieved through this “stab incision” with a meniscal probe49 (FIG. 26) and the sutures are tied after all of the sutures have been put into place.
• For a meniscal tear in the more posterior position, the straight cannula can enter through the ipsilateral portal to reach the posterior horn of the meniscus (FIG. 27a). The cannula can also be contoured to reach a specific zone of the meniscus with the use of the cannula bender and the template for the various zones (FIG. 27b).
• During repair of the meniscus, if the tip of the cannula cannot engage the tip of the needle during initial passage of the suture, the suture may be fed through the posterior needle into the joint. The suture may then be retrieved with a snap or a suture retriever50 (FIG. 28). The first needle is removed and the suture is fed into the cannula in a retrograde direction (FIG. 29). The cannula is advanced into the joint along the suture. The suture is then looped onto the distal guide and threaded back into the cannula until it reaches the tip of the cannula. The suture is then engaged onto the proximal guide (FIG. 30).
• The suture is then advanced into the tip of the second needle under arthroscopic visualization (FIG. 31). The suture is advanced until it exits from the hub of the second needle. The second needle is slightly pulled back so that the tip of the needle is buried within the soft tissue. The suture is disengaged from the guides on the handle of the suture passer and the suture is pulled through the cannula into the joint.
• The suture passer can also be used to pass the suture from the suture passer to the hollow needles, instead of vice versa. The suture passer is loaded with a suture so that the suture engages the first and second guide means with the “beginning” and “terminal” ends of the suture protruding from the distal opening of the hollow cannula. The beginning end of the suture is fed from the distal opening of the hollow cannula through the opening of the first hollow needle until it exits the first hollow needle. The terminal end of the suture is passed from the distal opening of the hollow cannula through the opening of the second hollow needle until it exits the second hollow needle. The suture is then completely disengaged from the suture passer, the suture passer is removed, both hollow needles removed and the suture is tightened and tied.
• By maneuvering the tip of the needle with one hand and the cannula in the other when both tips are in close proximity, the suture may be advanced.
• In another method, the suture protrudes from the cannula by about ½ to 1 centimeter. By manipulating the tip of the cannula with the tip of the needle, one can engage the suture into the tip of the needle and advance the suture.
• An arthroscopic video camera may be used to visualize the suturing. The surgeon manipulates the suture preferably while viewing a video monitor connected to the camera.
• A recommended suture for use is the Ethicon “O” PDS suture. The length of the suture should be at least 27 inches and preferably 36 inches in length. With other types of monofilament suture, the strand tends to be curled when removed from the packaging. It is necessary to straighten out the suture prior to use, as the ends of the suture must be straight for ease of passage of the suture between the cannula and the needle.
• It is preferable that the suture being used have distinct markings to give an enhanced visual indication of the movement of the suture. Different types and colors or markings along the length of the suture will indicate how much suture has been advanced. It is preferred that the suture have distinct markings at the beginning and terminal ends of the suture, which could indicate the length of the suture which has been advanced.
• If the meniscal tear is large, the repair operation should begin at the anterior portion of the tear. After the placement of the anterior suture, it will be easier to work along the anterior joint line to the posterior part of the tear. The medial meniscus is repaired with the knee in near extension or slight flexion. The lateral meniscus is repaired with the knee in 45.degree. to 90.degree. flexion.
• In a further modification of the invention, the suture passer may be formed in a modular fashion so that a variety of different cannulas can be attached to its handle. These cannulas may be blunt (in the manner shown inFIGS. 1-3,6,7A,7B,14-23,27A,27B and29-31) or sharply pointed, and they may be pre-formed straight (in the manner shown inFIGS. 1-3,6,7A,7B,14-23,27A and29-31) or already curved.
• More particularly, and looking now atFIGS. 32-43, amodular suture passer100 is shown.Suture passer100 generally comprises acannula200 and ahandle300.Cannula200 and handle300 are configured for releasable locked engagement with one another.
• More particularly, and still looking now atFIGS. 32-43,cannula200 comprises an elongatetubular member202 and a thin, outwardly extendingradial fin204.Fin204 is attached totubular member202 adjacent to the tubular member's proximal end206 (seeFIGS. 36,38 and40).
• Tubular member202 may be formed out of a single piece of tubing if desired. Alternatively, it may be formed out of a plurality of concentric tubes so as to increase the rigidity oftubular member202, e.g. to assist in penetrating tough tissue. In the specific embodiment shown inFIGS. 32-43,tubular member202 is shown formed out of threeconcentric tubes202A,202B and202C (seeFIGS. 40 and 42). The inner diameter of tube202C is selected so as to engage the outer diameter of tube202B, and the inner diameter of tube202B is selected so as to engage the outer diameter oftube202A. In addition,tube202A is sized so as to have the longest length, tube202C is sized so as to have the shortest length, and tube202B is sized so as to have an intermediate length. The proximal ends oftubes202A,202B and202C are aligned with one another so that tube202B projects out of tube202C andtube202A projects out of tube202B, and then the resulting structure is secured in place by welding or some other suitable process. It will be appreciated that acannula200 comprising the foregoing structure will be quite strong.
• The cannula'sfin204 comprises amain portion208 and a tab portion210 (seeFIGS. 36,38,40 and41).
• Main portion208 has a proximal edge212 (seeFIG. 40) which is substantially aligned with theproximal end206 of the cannula'stubular member202.Main portion208 also has abottom edge214 which is spaced from the outer surface oftubular member202 by a distance which is slightly less than the height of handle300 (seeFIG. 36).Main portion208 also has a distal edge216 (seeFIG. 40) which extends between the main portion'sbottom edge214 and the outer surface oftubular member202.
• Tab portion210 extends centrally and proximally fromproximal edge212 of the fin's main portion208 (seeFIG. 40).Tab portion210 is located in the same plane as main portion208 (seeFIG. 41) and is preferably generally rectangular in shape, although other tab shapes may also be used without departure from the present invention.Tab portion210 includes an upper tab projection218 (seeFIG. 40) which projects upwardly out of the tab portion'supper edge220, and alower tab projection222 which projects downwardly out of the tab portion'slower edge224.Upper tab projection218 defines an upper, distally facingtab shoulder226, andlower tab projection222 defines an lower, distally facingtab shoulder230.Tab projections218 and222 are located between theproximal edge212 of the fin'smain portion208 and theproximal edge232 of tab portion210 (seeFIG. 40). Tab shoulders226 and230 are aligned with one another.
• Looking next atFIGS. 32-39 and39A, handle300 comprises afirst suture guide302 and asecond suture guide304.
• First suture guide302 includes an eyelet306 (seeFIGS. 32 and 33). Apassageway308 is provided to permit a length of suture (not shown inFIGS. 32-39 and39A) to be slid transversely intoeyelet306.
• Still looking now atFIGS. 32-39 and39A,second suture guide304 comprises a generally semi-cylindrical member extending upwardly out of the handle's top side, between the handle's distal upper surface310 (seeFIGS. 32-34) and its proximalupper surface312. An axial bore314 (seeFIGS. 36 and 38) extends longitudinally throughsecond suture guide304. A top slot316 (seeFIGS. 32-34 and36) extends down intosecond suture guide304, transverse to the longitudinal axis of the handle. A right side slot318 (seeFIGS. 33 and 36) extends between the second suture guide'sdistal end320 and itstop slot316. A left side slot322 (seeFIG. 32) extends between the second suture guide'sproximal end324 and itstop slot316.Top slot316,right side slot318 andleft side slot322 effectively bifurcatesecond suture guide304 into a pair of closely spaced, oppositely extending fingers. These fingers can be considered to be somewhat analogous to the fingers14-16 shown inFIGS. 7A and 7B and described above. In view of the foregoing construction, a length of suture (not shown inFIGS. 32-39 and39A) may be aligned parallel to the second suture guide'stop slot316, then dropped into the top slot, and thereafter rotated 90.degree. into theright side slot318 and900 into theleft side slot322, so that the suture enters theinterior bore314 ofsecond suture guide304.
• Still looking now atFIGS. 32-39 and39A, handle300 also comprises a first bore326 (seeFIGS. 36 and 38) which extends proximally and axially from the distal end of the handle toward the proximal end of the handle. First bore326 includes a stop327 (seeFIGS. 36 and 38) at its proximal end. First bore326 is sized so as to be able to receive the proximal portion of a cannula'stubular member202. First bore326 is positioned so that when the cannula'stubular member202 is received in the handle'sfirst bore326, the central lumen of the tubular member will open onto the handle's distalupper surface310, betweenfirst suture guide302 and second suture guide304 (seeFIG. 36).
• A vertical slot328 (seeFIGS. 35-37,37A,38,39 and39A) extends downwardly fromfirst bore326.Vertical slot328 opens on the handle's bottom surface330 (seeFIG. 36), and is sized to receive themain portion208 of afin204 when acannula200 is mounted to handle300.
• Still looking now atFIGS. 32-39 and39A, a snap lock332 (seeFIGS. 35-37,37A,38,39 and39A) is formed at the proximal end ofvertical slot328.Snap lock332 comprises acavity333 formed inhandle300 immediately proximal to slot328 (seeFIGS. 35-37,37A and38).Cavity333 is sized to receive thetab portion210 of afin204 when acannula200 is mounted to handle300. The right sidewall ofcavity333 comprises a proximally extending continuation334 (seeFIGS. 37A and 39A) of the right sidewall ofvertical slot328.Continuation334 has a length substantially equal to the distance between theproximal edge212 of the cannula'smain fin portion208 and the distally facing tab shoulders226 and230 of the cannula's tab portion210 (seeFIG. 40). The left sidewall ofcavity333 comprises an outward tapering336 (seeFIGS. 37A and 39A) of the left sidewall ofvertical slot328.
• Snap lock332 also comprises a sloping upper sidewall projection338 (seeFIGS. 36 and 38) extending inwardly intocavity333 from thecontinuation334 of the right sidewall ofvertical slot328, and a sloping lower sidewall projection340 (seeFIGS. 37,38 and39A) extending inwardly intocavity333 from thesame continuation334.Upper sidewall projection338 defines an upper, proximally facing sidewall shoulder342 (seeFIG. 38) andlower sidewall projection340 defines a lower, proximally facing sidewall shoulder344 (seeFIGS. 37A,38 and39A).Upper sidewall shoulder342 is aligned withlower sidewall shoulder344.
• Upper andlower sidewall projections338 and340 are located such that as thetab portion210 of a givencannula200 enters the handle'scavity333, the cannula's upper andlower tab projections218 and222 will snap over and lockingly engage the handle's upper andlower sidewall projections338 and340 when the cannula is fully inserted into the handle'sfirst bore328. In particular, when the assembly is in this locked condition, the cannula's distally facingupper tab shoulder226 will engage the handle's proximally facingupper sidewall shoulder342, and the cannula's distally facinglower tab shoulder230 will engage the handle's proximally facing lower sidewall shoulder344 (seeFIG. 36).
• When a givencannula200 has been mounted to thehandle300 in the foregoing manner, rotational movement of the cannula relative to the handle is precluded by the engagement of the cannula'smain fin portion208 with the sidewalls of the handle'sslot328. In addition, axial movement of the cannula relative to the handle is precluded (i) in the proximal direction by the engagement of theproximal end206 of thecannula200 with thestop327 located at the proximal end of the handle'sfirst bore326, and (ii) in the distal direction by the engagement of the cannula's two distally facing tab shoulders226 and230 with the handle's two proximally facing sidewall shoulders342 and344.
• The handle of themodular suture passer100 also includes means for releasing a cannula from its locking engagement with the handle. More particularly, and still looking now atFIGS. 32-39 and39A, a second longitudinal bore348 (seeFIGS. 36,37,37A,38,39 and39A) extends between the proximal end350 (seeFIG. 36) ofcavity333 to the proximal end352 (seeFIGS. 36 and 38) ofhandle300.Second bore348 includes a distal portion354 (seeFIGS. 36 and 38) communicating withcavity333, an enlargedintermediate portion356, and aproximal portion358 opening on the handle'sproximal end352. A proximally facing annular shoulder360 (seeFIGS. 36 and 38) is formed at the intersection of the bore'sdistal portion354 with itsintermediate portion356, and a distally facingannular shoulder362 is formed at the intersection of the bore'sproximal portion358 with itsintermediate portion356. The bore'sdistal portion354 is sized so that the proximalmost portion ofcannula tab210 may be contained therein (seeFIG. 36).
• A release rod364 (seeFIGS. 36,37,37A,38,39 and39A) is slidably disposed insecond bore348. More particularly,release rod364 comprises a distal portion366 (seeFIGS. 36 and 38), an enlargedintermediate portion368, and aproximal portion370. A distally facing annular shoulder372 (seeFIGS. 36 and 38) is formed at the intersection of the rod'sdistal portion366 and itsintermediate portion368, and a proximally facingannular shoulder374 is formed at the intersection of the rod'sproximal portion370 and itsintermediate portion368. A spring376 (seeFIGS. 36 and 38) is captivated betweenbore shoulder360 androd shoulder372 so as to biasrelease rod364 proximally (seeFIGS. 36 and 37). The engagement ofrod shoulder374 withbore shoulder362 limits proximal movement ofrelease rod364.Release rod364 can be urged distally against the power ofspring376 by pressing on the rod's proximal end378 (seeFIGS. 38 and 39). The distal end ofrelease rod364 is bevelled so as to form anend surface380, adeflection surface382, and a drive surface384 (seeFIG. 37A).
• To release acannula200 fromhandle300, the proximal end378 (seeFIGS. 36 and 37) ofrelease rod364 is forced distally so as to move the release rod against the biasing force ofspring376. Asrelease rod364 moves distally throughhandle bore348, the release rod's deflection surface382 (seeFIG. 37A) will engage the proximal end232 (seeFIG. 40) of the cannula'stab portion210 and deflect thetab portion210 laterally so as to disengage the cannula's distally facing tab shoulders226 and230 (seeFIG. 40) from the housing's proximally facing sidewall shoulders342 and344 (seeFIGS. 36 and 38). Asrelease rod364 continues to move distally throughhandle bore348, the release rod's drive surface384 (seeFIG. 37A) will engage the cannula's proximal surface232 (seeFIG. 40), whereby the entire cannula will be driven distally so that the cannula's twotab projections218 and222 will clear the housing's twosidewall projections338 and340 (seeFIGS. 38,39 and39A). This will unlock the cannula from the handle.Cannula200 may thereafter be manually withdrawn from the handle by pulling the cannula in a distal direction.
• Thus it will be seen that a variety ofdifferent cannulas200 can be releasably attached to thehandle300. These cannulas can be a blunt or sharply pointed, and they may be straight or curved, as required for a particular surgical procedure.
• For example, a straight, sharply pointedcannula200 is shown inFIGS. 32-43. Preferably, the pointed distal end of this cannula is formed by cutting the distal end of the cannula at a first, relatively sharp angle so as to form a sharp penetrating edge at270 (seeFIGS. 40,42 and43), and then at a second, somewhat less severe angle so as to form a shallower tapering edge at272. The cannula is preferably blunted or rounded off at274 (seeFIGS. 42 and 43) so as to minimize the possibility of damaging a suture during a tissue piercing operation, as will hereinafter be discussed in further detail.
• FIGS. 44 to 49 exemplify some of the other cannula configurations which may be utilized withhandle300. Specifically, these exemplary configurations include a curved, sharply pointed cannula200 (FIG. 44); another curved, sharply pointed cannula200 (FIG. 45); still another curved, sharply pointed cannula200 (FIG. 4-6); a “cork-screw”, sharply pointed cannula200 (FIG. 47); a straight, blunt cannula200 (FIG. 48); and a curved, blunt cannula200 (FIG. 49). If desired, a reinforcingtube202D (seeFIGS. 45,46,47 and49) can be added to thetubular member202 so as to further strengthen the tube against undesirable bending during tissue penetration.
• Still other possible cannula configurations will be well known to those skilled in the art.
• It is anticipated that a surgeon will select aparticular cannula200 depending on the particular surgical procedure which is to be carried out. For example, if the surgical procedure ofFIGS. 14-26 or the surgical procedure ofFIGS. 27A,27B and28-31 is to be carried out, the surgeon might select the straight, blunt cannula ofFIG. 48 or the straight, sharply pointed cannula ofFIGS. 40-43.
• It will also be appreciated thatmodular suture passer100 can be used in many different ways to pass a length of suture through tissue. For example,FIGS. 50-52 illustrate one possible way in which a straight, sharply pointedcannula200 might be used to pass suture through a piece oftissue500.
• More particularly, and looking now atFIG. 50, a length ofsuture400 may be attached to thesuture passer100 by threading the suture through the suture passer'sproximal guide member304, through itscannula200 and then back around itsdistal suture guide302. This will allow the surgeon to adequately control the two ends of the suture during the tissue penetration operation.
• The pointed distal end of the suture passer'scannula200 is then driven into and through the piece of tissue500 (seeFIG. 51). As this occurs, the suture extending out of the cannula's sharp distal tip will be forced against the blunt heel274 (seeFIG. 43) of the cannula. The cannula'sblunt heel274 will support the suture during tissue penetration and prevent the cannula from cutting or otherwise damaging the suture as the suture is carried through the tissue. Then the loop of suture residing at the far side oftissue500 may be grasped by another tool (not shown), one or both of the suture ends freed from thesuture passer100, andsuture passer100 withdrawn from tissue500 (seeFIG. 52). At this point the suture will have been passed throughtissue500, with a loop of suture positioned on one side of the tissue and the two free suture ends positioned on the other side of the tissue.
• FIGS. 53-55 illustrate how a simple stitch can be established across two pieces of tissue using the present invention. More particularly, a length ofsuture400 is first loaded ontosuture passer100 by feeding oneend400A of the suture into the suture passer'scannula200.Suture end400A is left sitting within the length ofcannula200.Suture length400B is loaded onto the suture passer'sproximal suture guide304. The intermediate portion ofsuture400 will extend along the handle's distalupper surface310. Then the distal end of the suture passer'scannula200 is forced through two pieces oftissue500A and500B until the distal end of the cannula exits the tissue. Next the surgeon urgessuture400 distally through the cannula untilsuture end400A exits the tip of the cannula (seeFIG. 53). Then the suture passer is withdrawn fromtissue500A and500B, paying out the suture as it goes, so thatsuture400 extends through both pieces of tissue (seeFIG. 54). Next,suture400 is withdrawn from the suture passer and suture ends400A and400B are tied off into a knot (seeFIG. 55).
• FIGS. 56-58 illustrate how a suture loop can be passed across two pieces of tissue using the present invention. More particularly, a length ofsuture400 is first loaded ontosuture passer100 by feeding oneend400A of the suture into the suture passer'scannula200. Suture end400A extended all the way out the distal end of the cannula (seeFIG. 56).Suture end400A is then brought back to the suture passer's handle, so that the length of the suture will engage the bluntedneedle heel274 as it exits from the cannula (seeFIG. 57). Alternatively,suture end400A could be left dangling until the force of tissue penetration brings suture end400A back against the bluntedneedle heel274.Suture length400B is loaded onto the suture passer'sproximal suture guide304. The intermediate portion ofsuture400 will extend along the handle's distalupper surface310. Then the distal end of the suture passer'scannula200 is forced through two pieces oftissue500A and500B until the distal end of the cannula exits the tissue. As this occurs the suture will be carried through the tissue so that a loop of suture will reside on the far side of the tissue (seeFIG. 58). Then the suture passer is withdrawn fromtissue500A and500B, paying out the suture as it goes, so that both suture ends400A and400B will reside on the near side of the tissue, with a loop of suture remaining on the far side of the tissue.
• FIGS. 59-61 illustrate two different ways a folded suture loop can be passed across two pieces of tissue using the present invention. More particularly, a portion of suture (i.e., either the two suture ends400A and400B, or the intermediate portion of suture extending between the two suture ends400A and400B) is placed inside the cannula200 (seeFIG. 59). Then the cannula is inserted throughtissue500A and500B so that the distal end of the cannula emerges on the far side of the tissue. Next, the portion of suture previously held in the cannula (i.e., either the two suture ends400A and400B, or the intermediate portion of suture extending between the two suture ends400A and400B) is pushed outside the distal end of the cannula (seeFIG. 60). Finally, the cannula is withdrawn from the tissue, leaving a loop of tissue residing on one side of the tissue and the two suture ends residing on the other side of the tissue (seeFIG. 61).
• FIGS. 62-64 illustrate how a simple stitch can be converted to a mattress stitch with a suture loop using the present invention. More particularly, a loop ofsuture402 is first positioned on the far side of the tissue using the technique ofFIGS. 56-58, and a single strand ofsuture404 is passed through the tissue using the technique ofFIGS. 53 and 54 (seeFIG. 62). Then the end ofsuture404 is drawn through the loop of suture402 (seeFIG. 63). Finally the loop ofsuture402 is withdrawn back throughtissue500A,500B, carrying the strand ofsuture404 with it (seeFIG. 64).
• The foregoing description of the preferred embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention not be limited by this detailed description. present invention relates to systems and methods used in orthopaedic surgery, and in particular, to total knee arthroplasty. Those of skill in the art will recognize that the systems and methods described herein may be readily adapted for any total joint arthroplasty procedure. Those of skill in the art will also recognize that the following description is merely illustrative of the principles of the invention, which may be applied in various ways to provide many different alternative embodiments. This description is made for the purpose of illustrating the general principles of this invention and is not meant to limit the inventive concepts in the appended claims.

Claims (18)

1. A suture passer comprising:

a hollow cannula having a central passage sized to receive a surgical suture, the hollow cannula extending along a path;

a manually graspable handle adapted to engage the hollow cannula, the handle having a distal end and a proximal end;

a first suture guide positioned proximate the distal end of the handle to guide the surgical suture; and

a second suture guide positioned proximally of the first suture guide to guide the surgical suture;

wherein the path comprises nonplanar curves positioned at the distal end of the hollow cannula, the curves collectively having a first end, a second end, and an inflection point located between the first and second ends, wherein each of the curves terminates after making a less than full-circle rotation about its corresponding axis.

2. The suture passer ofclaim 1, wherein each of the curves comprises a first curve and a second curve, wherein the first portion resides within a plane and the second portion extends outside of the plane.

3. The suture passer ofclaim 1, wherein the hollow cannula further comprises a proximal portion and distal portion extending along proximal and distal portions of the path, respectively, wherein the proximal portion of the path extends longitudinally along a first axis, wherein the distal portion of the path extends is curved about a second axis oriented obliquely relative to the first axis.

4. The suture passer ofclaim 1, wherein the curves are substantially corkscrew shaped.

5. The suture passer ofclaim 1, wherein the hollow cannula is substantially non-removably attached to the handle.

6. The suture passer ofclaim 1, wherein the hollow cannula further comprises a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions, wherein the hollow cannula comprises a shoulder positioned proximate the first suture guide and a transitional region toward the distal end of the hollow cannula, wherein at the shoulder, an outside diameter of the cannula decreases abruptly toward the distal end of the cannula, wherein at the transitional region, an outside diameter of the cannula decreases more dramatically toward the distal end of the cannula than at portions of the cannula immediately proximal and distal to the transitional region.

7. A suture passer comprising:

a longitudinally extending hollow cannula having a central passage sized to receive a surgical suture, the hollow cannula having a proximal portion and distal portion, the distal portion extending along a path;

a manually graspable handle adapted to engage the hollow cannula, the handle having a distal end and a proximal end;

a first suture guide positioned proximate the distal end of the handle to guide the surgical suture; and

a second suture guide positioned proximate the first suture guide to guide the surgical suture;

wherein the path comprises nonplanar curves positioned at the distal end of the hollow cannula, the curves collectively having a first portion and a second portion, wherein the first portion resides within a plane and the second portion extends out of the plane, wherein each of the curves terminates after making a less than full-circle rotation about its corresponding axis.

8. The suture passer ofclaim 7, wherein the curves are substantially corkscrew shaped.

9. The suture passer ofclaim 7, wherein the proximal portion of the path extends longitudinally along a first axis, wherein the distal portion of the path extends is curved about a second axis oriented obliquely relative to the first axis.

10. The suture passer ofclaim 7, wherein the hollow cannula is substantially non-removably attached to the handle.

11. The suture passer ofclaim 7, wherein the hollow cannula further comprises an intermediate portion between the proximal and distal portions, wherein the hollow cannula comprises a shoulder positioned proximate the first suture guide of the cannula and a transitional region toward the distal end of the cannula, wherein at the shoulder an outside diameter of the cannula decreases abruptly toward the distal end of the cannula, and at the transitional region an outside diameter of the cannula decreases more abruptly toward the distal end of the cannula.

12. A suture passer comprising:

a hollow cannula having a central passage sized to receive a surgical suture, the hollow cannula having a proximal portion and distal portion, the proximal portion extending longitudinally along a first axis, the distal portion extending along a path;

a manually graspable handle adapted to engage the hollow cannula, the handle having a distal end and a proximal end;

a first suture guide positioned proximate the distal end of the handle to guide the surgical suture; and

a second suture guide positioned proximate the first suture guide to guide the surgical suture;

wherein the path is curved with nonplanar curves oriented oblique relative to the first axis, wherein each of the curves terminates after making a less than full-circle rotation about its corresponding axis.

13. The suture passer ofclaim 12, wherein the path is substantially corkscrew shaped.

14. The suture passer ofclaim 12, wherein the hollow cannula is substantially non-removably attached to the handle.

15. The suture passer ofclaim 12, wherein the hollow cannula further comprises an intermediate portion between the proximal and distal portions, wherein the hollow cannula comprises a shoulder toward the proximal end of the cannula and a transitional region toward the distal end of the cannula, wherein at the shoulder an outside diameter of the cannula decreases abruptly toward the distal end of the cannula, and at the transitional region an outside diameter of the cannula decreases more abruptly toward the distal end of the cannula.

16. A suture passer comprising:

a hollow cannula having a central passage sized to receive a surgical suture, the hollow cannula having a proximal portion, a distal portion terminating in a distal end, and an intermediate portion between the proximal and distal portions;

a manually graspable handle adapted to engage the hollow cannula, the handle having a distal end and a proximal end;

a first suture guide positioned proximate the distal end of the handle to guide the surgical suture; and

a second suture guide positioned proximate the first suture guide to guide the surgical suture such that the suture is exposed between the first and second suture guides;

wherein the hollow cannula comprises a shoulder toward the proximal end of the cannula and a transitional region toward the distal end of the hollow cannula, wherein at the shoulder, an outside diameter of the cannula decreases abruptly toward the distal end of the cannula, and at the transitional region an outside diameter of the cannula decreases more abruptly toward the distal end of the cannula.

17. The suture passer ofclaim 16, wherein the hollow cannula is substantially non-removably attached to the handle.

18. The suture passer ofclaim 16, wherein along the proximal portion, the outside diameter is substantially constant.

Images