The present invention relates generally to methods and apparatus for delivering implant structures and for repairing tom tendons. More particularly, the present invention describes methods and apparatus for delivering an implant structure to a targeted location beneath a partially or fully torn tendon, or combination, in a manner that minimizes further trauma to the tendon and facilitates repair of the tendon.
Conventional methods of soft tissue repair (e.g., partial articular-sided tendon tears) are quite time consuming, require a multitude of instruments, and often times cause additional trauma to the very soft tissue being repaired. One known method requires use of a conventional cannula instrument (100), as shown in
As an initial step in this conventional method, a localizing pin (e.g., a needle) is advanced through the damaged soft tissue to localize and create a path to a targeted location in the bone beneath the soft tissue. The localizing pin is then removed and a punch, and sometimes a tap for relatively hard bone, is advanced through the path created via the localizing needle to the targeted location. As can be appreciated by those in the art, once the localizing pin is removed, the surgeon is left to blindly attempt to advance the punch, and sometimes tap, through the soft tissue along the same path and with the same trajectory as that defined by the localizing pin. Often times, surgeons are unable to duplicate the exact path or trajectory created by the localizing pin resulting in longer surgery times and further trauma to the soft tissue.
Accordingly, it would be desirable to have a method and apparatus for effectively and efficiently repairing soft tissue and/or tendons. It would also be desirable to have a method and apparatus for effectively targeting areas beneath soft tissue or tendons and delivering instruments and/or implant devices thereto, while at the same time minimizing any additional trauma to the soft tissue or tendons.
This Application is directed to a method and apparatus for repairing damaged soft tissue or tendons, and in that regard, to a method and apparatus for delivering instruments and/or implant structures to a targeted location beneath the damaged soft tissue or tendon. The novel apparatus for delivering instruments and/or implant structure to a desired location includes a cannula comprising a hollow, elongated body having a first end and a second end. The first end of the cannula may be symmetrically or eccentrically tapered, and it defines a targeting extension. The targeting extension includes an extension tip that is distal from the cannula body and adapted for temporarily affixing the cannula to the targeted location. The targeting extension is also adapted for direct insertion through soft tissue or tendon, thereby providing access to the targeted location through an opening in the soft tissue or tendon.
The apparatus may also include a punch adapted for creating a pilot hole in the targeted location for receiving a suture anchor implant structure. The punch includes a punch tip and is sized and adapted to advance through the cannula body and through the opening in the soft tissue or tendon to the targeted location. The punch tip is itself adapted to penetrate the targeted location and create a pilot hole.
A novel method of delivering an implant structure in accordance with the present invention includes targeting an implant location. Next, a cannula is provided. The cannula preferably comprises a hollow, elongated body having a first end and a second end, and is sized and adapted to provide access to the targeted implant location. The first end of the cannula body may be symmetrically or eccentrically tapered, and defines a targeting extension. The targeting extension includes an extension tip that is distal from the cannula body and adapted for temporarily affixing the cannula to the targeted location. The targeted location is then localized and the targeting extension is temporarily affixed to the targeted location. Then, a punch having a punch tip adapted for penetrating the targeted location and for creating a pilot hole is provided and advanced through the cannula to the targeted location to create the pilot hole. Once the pilot hole is created, the punch is removed from the cannula and an implant structure (or any other instruments/devices) may be delivered through the cannula into the pilot hole created via the punch.
A novel knot-less method of repairing a torn tendon (or any soft tissue) includes delivering one or more suture implant structures to one or more targeted implant locations in a bone area beneath a torn tendon, wherein the delivered implant structures each include one or more suture limbs. Any of the novel cannula and punch described above may be utilized in the delivery. Once delivered, the implant structures are anchored to the targeted areas. Suture limbs emanating from the implant structures are then laterally spanned over the tendon. Each suture limb is then engaged with a limb-anchoring structure, and pulled to tension the suture limbs. The limb-anchoring structures are then introduced and affixed to locations that are lateral and/or distal to the targeted locations, thereby securing and compressing the tendon to its bony attachment site.
For the purpose of illustrating the invention, the drawings show forms of the invention that are presently preferred. However, it should be understood that this invention is not limited to the precise arrangements and instrumentalities shown in the drawings.
Described herein are novel methods and apparatus for use in repairing partially and/or fully torn tendons (e.g., rotator cuff, Achilles, etc.), or a combination thereof (e.g. fully-torn tendon with partial tear component). In general, a tendon repair involves targeting an implant location in a bone area beneath the damaged tendon, creating a pilot hole in the bone, delivering and affixing a suture implant structure into the pilot hole, and then using the implant structure sutures to compress the tendon against the bone. To that end, the present invention describes a novel cannula or tube, a novel punch, and a novel method of utilizing both instruments in a manner that increases surgical efficiency and minimizes soft tissue trauma during a tendon repair procedure.
In a first exemplary embodiment, the present invention relates to a cannula instrument configured for advancing through any soft tissue (e.g., a tendon), for targeting a location in an area beneath the soft tissue (“targeted location”), and for providing a pathway to the targeted location for other instruments useful in repairing the soft tissue (e.g., punch, tap, suture anchor implants, etc.). For purposes of this disclosure, the term “targeted location” simply refers to an area, typically beneath a damaged tendon or soft tissue, that is suitable for advancing and/or anchoring one or more instruments or devices (e.g., suture implant, anchor, suture-locking or interference structure; etc.) in a manner that facilitates repair of the damaged tendon or soft tissue.
Referring now to
At one end, the cannula (300) may be eccentrically tapered so as to define a targeting extension (303) adapted for directed insertion through soft tissue (e.g., tendon) to a targeted location beneath the soft tissue. The exemplary targeting extension (303) further defines an extension tip (307) that is distal from the cannula body (301) and is adapted for temporarily affixing the cannula (300) to the targeted location. Since the targeted location is often a hard, bony surface, the extension tip (307) may also be constructed of a strong, durable and rigid material.
As shown in
In an alternate embodiment, one or both of the targeting extension (303) and/or the extension tip (307) may be configured as one or more independent components that may be added to existing cannula instruments. In such an embodiment, the targeting extension (303) and/or its tip (307) may be mounted, clipped, clamped, or otherwise fastened to existing cannula instruments in order to achieve the effect of the cannula instrument of the present invention. With regard to the extension tip (307), the tip (307) may be formed as a long and narrow needle-like instrument that may be inserted or removed from the cannula (300) through an opening that extends the entire length of cannula (300). In such an embodiment, the cannula (300) may be formed to define an additional opening that begins at one end and that extends along the entire length of the cannula (300). This opening may be sized to allow a needle-like extension tip (307) to enter the cannula (300) at one end and protrude through to the targeting extension (303) area.
Turning briefly to
Returning again to
Utilizing any of the novel cannula instruments described above (see
The novel cannula of this invention, in sharp contrast, provides a targeting extension that enables surgeons to locate and target areas beneath soft tissue while ensuring that additional instruments advanced through the soft tissue follow the path created by the targeted extension, thereby increasing the surgeons' efficiency and minimizing soft tissue trauma. To illustrate, reference is again made to
Once the targeted extension (303) is advanced through the tendon, rather than removing it from the tendon, the targeted extension (303) may be temporarily affixed to the targeted area, thereby providing a fixed pathway through which the suture anchor implants (and/or any other instruments) may advance. Since the cannula (300) does not have to be removed from the tendon, the surgeon does not have to blindly navigate for a pathway or pilot hole. Instead, the surgeon is able to advance instruments such as a punch, tap, suture anchors, etc. through the body (301) of the cannula (300) along the exact same path and trajectory as that created by the targeted extension (303). As can be appreciated by those in the art, utilizing a cannula (300) configured in this manner provides a visual-tactile feedback to the surgeon for implant placement. Providing this visual-tactile feedback enables the surgeon to limit the number of times that instruments are passed through the tendon, resulting in reduced trauma to the tendon and in a more efficient surgical procedure.
Referring now to
The exemplary punch instrument (500) comprises a shaft (501), a punch tip (503) at one end of the shaft (5.01), and an optional punch lid (505) at the other end of the shaft (501). Also included in this exemplary punch instrument (500) is an optional punch extension tip (507). The punch shaft (501) may be formed of any material and formed in any shape that is suitable for use during a surgical procedure. For example, the punch shaft (501) may be constructed of stainless steel, metal, metal alloy, plastic, polymer, a combination thereof, or any other suitable material, and shaped to define a circular (shown in
At one end of the punch shaft (501) is a punch tip (503). The punch tip (503) is configured for penetrating and/or advancing through soft tissue (e.g., tendon), and for penetrating and creating an opening (e.g., a pilot hole) in a hard surface (e.g., a bony targeted location) beneath the soft tissue. As noted above, the opening (e.g., in a bone area, through soft tissue) created by the punch tip (503) may be utilized for receiving and anchoring a surgical device such as a suture implant, or suture-locking or -interference structure. As shown in
Offsetting the punch point (504′) as illustrated in
Returning now to
Also included in the exemplary punch instrument (500) is an optional punch “lid” (505). The punch lid (505) may be formed of any durable, rigid material suitable for surgery and for receiving blunt force or pressure for forcibly advancing the punch (500), such as with a mallet or other instrument. In one embodiment, the punch lid (505) may be configured for receiving reverse force (e.g., back taps) for reversing the punch's (500) direction of advancement. To illustrate, if the punch (500) were used to penetrate and create an opening in a bone, one could “back-tap” the underside (506) of the punch lid (505) to facilitate removal of the punch (500) from the bone. In such an embodiment, the punch lid (505) may be sized and strengthened enough to receive reverse force, such as from a mallet or other instrument. Although the exemplary punch lid (505) is shown extending to one side of the punch (500), it should be understood that the punch lid may be configured to extend in any direction relative to the punch (500), or not at all, and may be configured as part of a handle.
As noted above, each of the novel cannula instruments and punch instruments described above may be utilized independently, or in combination with one another. In one embodiment, the exemplary cannula (300) of
Turning now to
Returning to
Inserted through the center of the cannula body (601) is the punch portion of the cannula-punch system (600). The punch portion primarily comprises a shaft (606), a punch tip (610) at one end of the shaft (606), and an optional punch lid (607) at the other end of the shaft (606). Also included in the exemplary punch is an optional punch extension (611).
The punch tip (610) is configured for penetrating and/or advancing through soft tissue (e.g., tendon), and for penetrating and creating an opening (e.g., a pilot hole) in a hard surface (e.g., a bony targeted location) beneath the soft tissue. In the present illustration, the punch tip (610) is shown to be symmetrically tapered (taper A′) such that its point converges along the punch's center axis. Alternatively, the punch tip (610) may be eccentrically tapered along the same angle as that of the cannula targeting extension (603) and tip (604)
J At one end of the punch portion, attached to the end of the punch tip (610), is an optional punch extension (611). The punch extension (611) may be formed as part of the punch tip (610) itself, or it may be an independent component that is attached (and removable) from the punch tip (610). Alternatively, the extension (611) may be formed as a long and narrow needle-like instrument that may be inserted or removed from the punch through an opening that extends the entire length of the punch itself. In such an embodiment, the needle-type punch extension (611) may be utilized to initially penetrate a damaged soft tissue in order to localize a targeted area beneath the soft tissue (such in a PASTA lesion surgery). Once the targeted area is located, the needle-like punch extension (611) may be removed (through the punch shaft (606)) and the punch may be advanced through the opening created by the needle-like extension (611). The needle may be removed after the punch is advanced as well.
Attached to the other end of the punch portion is an optional punch lid (607). The punch lid (607) may be formed of any durable, rigid material suitable for surgery and for receiving blunt force or pressure for forcibly advancing the punch into a hard surface (e.g., bone), such as with a mallet or other instrument. As shown, the punch lid (607) is configured for receiving reverse force (e.g., back taps) on an underside (609) of the punch lid (607) for reversing the punch's direction of advancement. The punch lid (607) is sized and strengthened enough to receive reverse force, such as from a mallet or other instrument. Although the exemplary punch lid (607) is shown extending to one side of the cannula-punch system (600), it should be understood that the punch lid (607) may be configured to extend in any direction relative to the cannula-punch system (600), or not at all, and may be configured as part of a handle.
All components of the cannula-punch system (600) may be formed of any material, and in any shape, that is suitable for use during a surgical procedure. For example, the punch and cannula portions (or any components comprising the same) of the system (600) may be constructed of stainless steel, metal, alloy, plastic, polymer, a combination thereof, or any other suitable material, and shaped to define a circular (shown in
In operation, the exemplary cannula-punch system (600) may be utilized as part of a soft tissue (partial or full tear, or combination (e.g. full-thickness tear with a partial-tear component)) repair surgery, for example, to advance and deliver one or more instruments to a targeted area beneath the damaged soft tissue. In one embodiment, the cannula-punch system (600) may be used to deliver one or more suture anchors or implants, or suture-interference or—locking structures to a targeted location in accordance with the novel delivery method described below and illustrated in
Turning now to
J Next, in step 703, a cannula device is provided. This cannula device preferably comprises a hollow, elongated body having a first end and a second end, and being sized and adapted to provide access to the targeted implant location. The first end of the cannula device may be eccentrically tapered defining a targeting extension that is distal from the cannula body and adapted for temporarily affixing the cannula to the targeted location (e.g., see
Once the cannula device is provided (step 703), the targeted location is localized and the targeting extension is advanced through the soft tissue or tendon (if necessary) and is temporarily affixed to the targeted location (step 705). This localizing and temporarily affixing step may be accomplished, for example, by piercing and creating an opening in the soft tissue or tendon, and by inserting the extension tip through the opening created in the soft tissue or tendon, respectively. As an option, a blunt-tip obturator may be provided and used to palpate the soft tissue or tendon just prior to piercing-and/or advancing the extension tip through the soft tissue or tendon. This will limit potential trauma to the soft tissue or tendon resulting from the extension tip, as the blunt obturator will help localize the area where the extension is to be advanced by providing visual-tactile feedback to the surgeon.
In one embodiment, the initial opening in the soft tissue or tendon may be created using a localizing needle, for example. Alternatively, the targeting extension may be configured with a pointed extension tip, in which case the initial opening may be created using the cannula targeting extension. In such an embodiment, the targeting (step 701) and localizing (step 705) steps may occur simultaneously using the pointed extension tip.
Next, a punch instrument is provided (step 707) and advanced through the cannula device step 709) to the targeted location. The punch instrument preferably includes a punch tip at one end that is adapted for penetrating soft tissues (e.g., tendon) and bard surfaces (e.g., bone), and for creating a pilot hole therein. Such a punch tip may be symmetrically tapered such that the punch tip converges along the punch's central axis, or the punch tip may be eccentrically tapered to follow the same line or projection as that of the cannula device targeting extension.
Optionally, the punch instrument may be further configured to include a needle-like punch extension that extends laterally in the same direction as the cannula targeting extension. This needle-like punch extension may be formed as part of the punch tip itself, or it may comprise an independent component that may be attached and/or removed from the punch tip. Alternatively, the punch extension may be formed as an independent needle-like instrument that may be inserted and removed through an opening that extends the entire length of the punch instrument itself. Punch instruments having this type of needle-like punch extension may be utilized to simultaneously target and localize the implant location (steps 701 and 705, respectively).
Once the punch is advanced through the cannula (step 709), the punch may be forcibly advanced into the targeted location (step 711) using a mallet or similar instrument, thereby creating a pilot hole. Notably, if the punch is advanced through soft tissue or tendon, then a pilot hole is also created in the soft tissue (in addition to bone). Next, the punch instrument may be removed from the cannula (step 713). To facilitate removal of the punch instrument (step 713), the punch instrument may further comprise an optional punch lid positioned at an end opposite that of the punch tip. This punch lid may include an undersurface configured for receiving reverse force (e.g., back tapping force from a mallet or similar instrument) for extracting the instrument if it becomes lodged in a bony targeted surface.
Upon removing the punch instrument from the cannula (step 713), an implant structure may be delivered (step 715) through the cannula device to the pilot hole created in the targeted location. Once delivered (step 715), the implant structure may be anchored (step 717) according to any known method of anchoring such a device. For implementations desiring to deliver screw-type implant structures (or any implant requiring the use of a tap prior to placement), the method (700) may further comprise (prior to delivering the implant structure (step 715)) the steps of: providing a tap instrument and delivering the tap instrument to the targeted location through the cannula device (step 719); and “threading” the pilot hole to receive a screw-type, or other appropriate, implant (step 721).
In an alternate implementation, the cannula device and punch instrument may be replaced with a cannula-punch system (e.g., see
Referring now to
Looking first to
As depicted in frame 8A, only the targeting extension has been advanced into the bony surface (805). In this manner, the cannula (80,1) may be temporarily affixed to the bony surface (805) without having to advance the full diameter of the cannula (801) into the bone (805). As can be appreciated by those in the art, advancing the full diameter of the cannula (801) into the bone may create a hole larger than threads of the screw-type implant, thereby compromising the fixation of the suture anchor implant. Once the cannula (801) is properly positioned, a punch (807) is shown advanced through the cannula (801) into the bony surface (805), thereby creating a pilot hole (810) for receiving the screw-type implant (813). Laser lines (809, 811) on the punch provide guidance for advancing the punch (807) to the correct depth.
Once the pilot hole (810) is created, the punch is removed through the cannula (801), as depicted in frame 8B. It is noted, however, that the cannula (801) remains temporarily affixed or engaged to the bony surface (805). By maintaining the cannula (801) temporarily affixed in place, the cannula (801) is able to provide a single guided pathway to the pilot hole (810) for delivering the screw-type implant (813).
Moving now to frame 8C, once the punch (807) has been removed, a tap device may be used to thread the pilot hole (not shown). The screw-type implant (813) may then be delivered through the cannula (801) and anchored in place. Once the implant (813) is anchored, the cannula (801) may be removed, and the implant sutures. (e.g., cord-like or band-like sutures) (815) may be utilized to affix soft tissue (not shown) to the bony surface (805).
Referring now to
As depicted in frame 9A, a punch obturator (907) is used in conjunction with the cannula (901) to simultaneously advance the cannula (901) and the punch obturator (907) into the bony surface (905). A ridge (908) on the top of the punch obturator (907) is used to drive the cannula (via the cannula handle (903)) into the bone (905) as the punch obturator (907) is itself struck with a mallet or similar instrument. Advancing the cannula (901) into the bone (905) in this manner temporarily affixes the cannula (901) in the bone (905). Laser lines (911) on the exterior of the cannula (901) may be used for guidance when advancing the cannula (901) to a correct depth. Alternatively, the cannula (901) need not be forcibly advanced, but rather engaged to the bone (905) via an extension and tip, in which case the ridge (908) would not be necessary and forcible advancement would be provided solely to the punch (907) component instrument directly.
Once the cannula (901) is properly advanced and affixed in the bone (905), the punch obturator (907) is shown removed from the cannula (901), thereby exposing a pilot hole (910) created in the bone (905) for receiving the toggle-type implant (913) (frame 9B). The toggle implant (913) is then ready to be advanced through the cannula (901) into the pilot hole (910), as depicted in frame 9B.
As shown, but not limited to this depiction, the toggle-type implant (913) includes at least two sutures (915) attached to each of two or more corresponding eccentric eyelets (914) for use in toggling the implant (913) once it is properly positioned. The toggle-type implant (913) also includes one or more barbs (913a) for use in anchoring the implant (913) to an undersurface of the bone (905) once the implant (913) is toggled or deployed.
Next, as depicted in frame 9C, toggle-type implant (913) is inserted and advanced along the cannula into the pilot hole (910). As depicted in frame 9D, the implant (913) is then toggled and the cannula (901) is fully removed from the bone (905). Once the implant (913) has been toggled, the sutures (915) are pulled to firmly engage the anchor implant barbs (913a) to the underside of the bone (905), thereby firmly anchoring the implant (913) in position. Once properly positioned, the implant sutures (e.g., cord-like or band-like) (915) may be utilized to securely attach soft tissue (not shown) to the bony surface (905).
Referring now to
As an initial step, one or more suture implant structures (each having one or more suture limbs) are delivered to a corresponding implant location in a bone area beneath the torn tendon (step 1010). Any method and/or apparatus may be utilized for delivering the suture implant structures according to step 1010, including, without limitation, any of the novel methods and/or cannula and punch devices described above. For example, a screw-type implant may be delivered using the method (700) of
Once delivered (step 1010), the implant structure(s) may be properly anchored in place (step 1030) according to the particular type of implant. For instance, screw-type implants may be screwed and tightened and toggle-type implants may be anchored by engaging an underside of the bony implant location.
In the context of a PASTA lesion repair, the implant structure(s) may be advanced through the tendon to their respective implant locations using any method and/or apparatus utilized for delivering the suture implant structures according to step 1010, including, without limitation, any of the novel methods and/or cannula and punch devices described above. As a result, suture limbs emanating from the implant structure(s) will have also been passed through the tendon. For full thickness tears, however, the implant structure(s) may be anchored directly beneath the tendon, without having to be advanced through the tendon. As a result, suture limbs emanating from the implant(s) will not have been passed through the tendon. In such scenarios, an added process step of passing the suture limbs back through the tendon will be required prior to advancing to the step below. However, alternatively, for full-thickness tears, implant structures may be advanced directly through the tendon as well, using any method and/or apparatus utilized for delivering the suture implant structures according to step 1010, including, without limitation, any of the novel methods and/or cannula and punch devices described above.
Next, the suture limbs (e.g., cord-type or band-type) emanating from the implant structures (and through the tendon) are each fastened to limb-anchoring structures (step 1050) and are laterally spanned over the tendon (step 1070). Any type of limb-anchoring structure, including suture-locking and/or suture-interference structures, may be utilized for securing the suture limbs. Once spanned, the sutures are pulled and tensioned (step 1090), via the limb-anchoring structures, and the limb-anchoring structures are affixed to locations that are lateral and/or distal to the implant locations (step 1100). In this manner, the suture limbs are able to secure and compress the tendon to its bony attachment site. Further, since limb-anchoring structures have been utilized, there is no need for knotting the sutures, thereby reducing the overall tendon repair time.
Turning now to
Emanating from each of the two implant locations (1, 2) are two pairs of suture limbs (1a, 1b and 2a, 2b), one each pertaining to each of the two implants. One suture limb from each of the two implant locations is fastened to one of two limb-anchoring structures (3, 4). That is, one suture limb from implant location 1 (1a) and one suture limb from implant location 2 (2a) is each fastened to anchoring structure 3, and a different suture limb from each of implant locations 1 and 2 (1b and 2b, respectively) is fastened to anchoring structure 4. Once the suture limbs (1a, 2a and 1b, 2b) are fastened to their respective limb-anchoring structures (3,4), the suture limbs are spanned over the tendon, pulled and tensioned, via the limb-anchoring structures (3,4), across the tendon. Next, the limb-anchoring structures (3,4) are affixed to their respective locations, which is shown in the diagram (1100), are lateral and/or distal to the implant locations (1, 2). Notably, the number of suture limbs emanating from each location (1,2) may exceed two, and therefore the possible number of suture spanning configurations is potentially more than that described above, particularly when multiple limb-anchoring structures (suture limb-locking or -interference structures) are utilized.
Alternatively, in a variation of the exemplary repair (1100) discussed above, the suture limbs (1a, 1b and 2a, 2b) from each of the implant locations (1, 2) may be fastened to a corresponding one suture limb-locking or -interference structure (or equivalent). In other words, both suture limbs (1a, 1b) emanating from the implant beneath location 1 may be fastened to limb-anchoring structure 4, and the suture limbs (2a, 2b) from the implant beneath location 2 may be fastened to limb-anchoring structure 3.
In yet another embodiment, rather than using multiple suture limb-anchoring structures to secure the suture limbs across a tendon (as the exemplary tendon repair of
Returning now to
Once the two implants are in place, the suture limbs (1220a, 1220c) are tensioned and fastened to a single limb-anchoring structure. The limb-anchoring structure is then affixed to location 12C, which is lateral and/or distal from implant locations 12A and 12B. In this manner, the suture (1220a-1220c) is able to cinch, compress, and secure the tendon (1205) to the bone area in a triangulated manner.
Alternatively, in a variation of the exemplary repair illustrated in
Alternatively, in another variation of the exemplary repair illustrated in
Referring now to
As alluded to above, any of the novel instruments and/or techniques described herein may be utilized (alone or in combination) to vastly improve existing tendon repair methods. Indeed, delivering implant devices using, for example, a cannula and punch apparatus of the present invention vastly improves the precision of such deliveries, while at the same time minimizing the risk of additional trauma to the tendon. Further, by spanning suture limbs across a damaged tendon, and then subsequently securing the suture limbs to lateral and/or distal locations using knotless limb-anchoring structures, superior tendon compression and fixation (against bone) is achieved. As a result, the quality of the overall repair and the time required to perform the repair procedure are both greatly improved. Furthermore, since the repair methods of the present invention reduce added tendon trauma and improve tendon-to-bone contact, the tendon itself will have a better opportunity to heal properly and in less time.
Although the invention has been described and illustrated with respect to the exemplary embodiments thereof, it should be understood by those skilled in the art that the foregoing and various other changes, omissions and additions may be made therein and thereto, without parting the spirit and scope of the present invention.