US20070156175A1 - Device for attaching, relocating and reinforcing tissue and methods of using same - Google Patents

Abstract

A device for attaching, relocating or reinforcing tissue includes a first tissue anchoring portion having a support plate and a plurality of barbs extending from the support plate for engaging tissue at a first location, a second tissue anchoring portion having a support plate and a plurality of barbs extending from the support plate for engaging tissue at a second location which is different from the first location, and a connection element, such as a suture or a mesh structure, interposed between and interconnecting the first tissue anchoring portion and the second tissue anchoring portion. The support plate of at least one of the first tissue anchoring portion and the second tissue anchoring portion may have longitudinally axially formed therethrough a bore for receiving the connecting element so that the surgeon may pull on the end of the connecting element to adjust the distance between the first tissue anchoring portion and the second tissue anchoring portion.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention generally relates to surgical devices for relocating and fixating soft tissue, and more particularly relates to a soft tissue anchoring device for attaching, relocating or reinforcing tissue, such as used in facial plastic surgery.
• 2. Description of the Prior Art
• In many types of surgery, there is a need to suspend soft tissue or relocate the tissue from one position to another. This is often done with sutures, but sutures can pull through the tissue and can be difficult to secure to the tissue by tying knots.
• Soft tissue anchors are also well known in the art and are used in different surgical procedures. For example, U.S. Pat. No. 6,645,226, which issued to Daniel Jacobs and Dirk Thye, and U.S. Pat. No. 6,485,503, which issued to Daniel Jacobs and Robert James Elson, the disclosures of which are incorporated herein by reference, disclose one form of a tissue approximation device and method for using the device, wherein the device is an implantable, biodegradable construct that is used to attach one tissue structure to another but requires the presence of natural tissue structures to achieve the desired lift. For example, the aforementioned U.S. Pat. No. 6,645,226 to Jacobs et al. describes a method where the periosteum in a patient's forehead is detached and then relocated by the surgeon. It is then held in place with the implantable tissue anchor disclosed in the patent. The aforementioned U.S. Pat. No. 6,485,503 to Jacobs et al. discloses a similar tissue anchoring device.
• The problems with such tissue anchoring devices disclosed in the aforementioned Jacobs et al. patents include the fact that the described tissue anchors cannot be implanted and then adjusted afterwards; the tissue anchors and the adjustment of the anchors to provide the desired lift must be done in a single step. Additionally, the tissue anchors disclosed in the aforementioned Jacobs et al. patents require the surgical creation of a rather large tunnel or elevated flap of tissue in order to relocate the tissue.
OBJECTS AND SUMMARY OF THE INVENTION
• It is an object of the present invention to provide a device for attaching, relocating or reinforcing tissue and methods of using such a device.
• It is another object of the present invention to provide a device for anchoring to and relocating a variety of tissue types and which is suitable for use in many different body locations and surgical procedures.
• It is still another object of the present invention to provide a device which can relocate and fixate tissue in a minimally invasive manner.
• It is a further object of the present invention to provide a device which can relocate and fixate tissue and which may be adjusted by the surgeon after being surgically implanted.
• It is yet a further object of the present invention to provide a device for anchoring to and relocating tissue which allows the physician to set the tissue engaging structures of the device first and then subsequently adjust the locations of or spacing between the tissue engaging structures.
• It is yet another object of the present invention to provide a device for anchoring to and relocating tissue whereby the amount of tissue relocation may be controlled by the surgeon at the time of placement of the device in a patient's body.
• It is still a further object of the present invention to provide a device for anchoring to and relocating tissue which may be implanted in a patient's body in open, endoscopic and blind surgical procedures.
• It is yet another object of the present invention to provide a device for attaching, relocating or reinforcing tissue and methods for using such a device which overcome the inherent disadvantages of known devices and methods.
• In accordance with one form of the present invention, a device for attaching, relocating or reinforcing tissue includes at least two tissue engagement means, including a first tissue engagement means and a second tissue engagement means, and a connection means interposed between and interconnecting the first tissue engagement means and the second tissue engagement means. The first tissue engagement means is located at the site of the tissue to be relocated. The second tissue engagement means is situated at the anchor site. Preferably, the device is adjustable so that the amount of displacement of the tissue may be controlled by the surgeon during the surgical implantation of the device. The first and second tissue engagement means, and the connection means, may be formed from either resorbable or non-resorbable material, and the resorption profile, stiffness, strength and other mechanical and material properties of the device may be tailored to meet the specific needs and objectives of the surgeon.
• These and other objects, features and advantages of the present invention will be apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a block diagram showing generically the three basic components of a device for attaching, relocating or reinforcing tissue formed in accordance with one form of the present invention.
• FIG. 2A is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a second form of the present invention.
• FIG. 2B is a cross-sectional view of the device of the present invention shown inFIG. 2A.
• FIG. 2C is a pictorial illustration of the device of the present invention shown inFIGS. 2A and 2B implanted in a patient during facial plastic surgery, and illustrating a method for using the device of the present invention.
• FIG. 3A is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a third form of the present invention.
• FIG. 3B is a cross-sectional view of the device of the present invention shown inFIG. 3A.
• FIG. 3C is a cross-sectional view of a portion of the device of the present invention shown inFIGS. 3A and 3B.
• FIG. 4 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a fourth form of the present invention.
• FIG. 5 is a cross-sectional view of the device of the present invention shown inFIG. 4A.
• FIG. 6 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a fifth form of the present invention.
• FIG. 7 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a sixth form of the present invention.
• FIG. 8 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a seventh form of the present invention.
• FIG. 9 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with an eighth form of the present invention.
• FIG. 9A is a cross-sectional view of a portion of the device of the present invention shown inFIG. 9.
• FIG. 10 is a perspective view of a device for attaching, relocating or reinforcing tissue formed in accordance with a ninth form of the present invention.
• FIG. 11A is a perspective view of a first form of a tissue engagement means of a device for attaching, relocating or reinforcing tissue formed in accordance with the present invention.
• FIG. 11B is a perspective view of a second form of a tissue engagement means of a device for attaching, relocating or reinforcing tissue formed in accordance with the present invention.
• FIG. 11C is a perspective view of a third form of a tissue engagement means of a device for attaching, relocating or reinforcing tissue formed in accordance with the present invention.
• FIG. 11D is a perspective view of a fourth form of a tissue engagement means of a device for attaching, relocating or reinforcing tissue formed in accordance with the present invention.
• FIG. 11E is a perspective view of a fifth form of a tissue engagement means of a device for attaching, relocating or reinforcing tissue formed in accordance with the present invention.
• FIG. 12 is a cross-sectional view of a pictorial illustration of the device of the present invention shown inFIG. 10 being implanted in a patient's heart to provide support for patients experiencing dilated congestive heart failure.
• FIG. 13 is a cross-sectional view of a pictorial illustration of the device of the present invention shown inFIG. 10 being implanted in a patient to support the patient's vagina in pelvic organ prolapse repair.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring initially toFIG. 1 of the drawings, it will be seen that, generically, a device for attaching, relocating or reinforcing tissue constructed in accordance with one form of the present invention includes at least two tissue engagement means, and a connection means interposed between and interconnecting the two tissue engagement means. The device of the present invention may include more than two tissue engagement means, such as the three tissue engagement means of the device of the present invention shown inFIG. 10, which will be described in greater detail. The first tissue engagement means2, which is also designated as “Part A” inFIG. 1, is a tissue anchoring portion of the device that is typically located at the tissue site to be manipulated (e.g., moved). The second tissue engagement means4, also referred to inFIG. 1 as “Part B”, is another tissue anchoring portion of the device that is typically located at the anchor site. The third primary component of the device of the present invention, which is also labeled as “Part C” inFIG. 1, is the connection means6 which is interposed between and connects the first tissue engagement means2 and the second tissue engagement means4. Part C, the connection means6, could not only be used as an interconnection between the first and secondtissue anchoring portions2,4, but may also be used to provide tissue support, as will be evident from the detailed description of the various embodiments of the present invention to follow.
• One form of the device of the present invention is illustrated byFIGS. 2A-2C. Part A, thetissue anchoring portion2 which is located at the tissue site to be manipulated, is a barbed, resorbable anchor preferably constructed to include aplanar support plate8 and a plurality ofbarbs10 extending outwardly from an exposed surface of thesupport plate8 and at an angle thereto, which is preferably between about 30 degrees and about 60 degrees, but is even more preferably at a 45 degree angle, between the barbs and the surface of thesupport plate8 from which they extend. One form of material that is resorbable that may be used in the construction of the first tissue engagement means2, i.e., the “Part A” tissue anchoring portion, is polydioxanone, as an example, but it is envisioned to be within the scope of the present invention to form the “Part A” tissue anchoring portion from other resorbable materials, such as those that will be described later in greater detail.
• When anchoring soft tissue to bone or periosteum, the second tissue engager is preferably a bone anchor. Otherwise, they can just be like the first tissue anchor. More specifically, the second tissue engagement means4, that is, the “Part B” tissue anchoring portion of the device of the present invention, is preferably formed as a bone anchor, such as the Biofastin RC threaded suture anchor manufactured by DePuy Mitek of Norwood, Mass., which has a bore formed through it to allow a suture to pass therethrough. The bone anchor is situated opposite the firsttissue anchoring portion2. Asuture12, preferably made from polypropylene, is the connection means6, i.e., the “Part C” of the device of the present invention shown generically inFIG. 1, which connects the barbed, resorbabletissue anchoring portion2 with theMitek bone anchor4.
• The embodiment of the present invention shown inFIG. 2A and 2B is particularly suitable for use in relocating the tissues of the midface of a patient by placing the barbedtissue anchoring portion2 in the malar fat pad, and placing thebone anchor4 in the skull above the temporal region, as illustrated byFIG. 2C, with thesuture12 extending between and connecting the twotissue anchoring portions2,4. The surgeon would implant both tissue anchors, and then pull on thesuture12 to adjust the location of the fat pad.
• A third form of a device for relocating tissue, constructed in accordance with the present invention, is shown inFIGS. 3A-3C. Here, two preferably permanent (i.e., non-resorbable) first and secondtissue anchoring portions2,4 (i.e., “Part A” and “Part B” shown inFIG. 1) are joined together with apermanent suture12 preferably made from polypropylene (i.e., the “Part C” connection means). The “Part A” softtissue anchoring portion2 includes asupport plate8 having an exposed surface from which angularly and outwardly extend relatively large barbs10 (i.e., relative to the “Part B” strong tissue anchoring portion4). Thebarbs10 extend from the surface of thesupport plate8 at preferably an angle of between about 30 degrees and 60 degrees, and more preferably, 45 degrees, in the direction of the Part B strongtissue anchoring portion4. Thesoft tissue anchor2 is fixedly joined to thepolypropylene suture12.
• The strong tissue anchoring portion (i.e., the “Part B” tissue engagement means4) may be in the form of a smaller support plate14 than that of the softtissue anchoring portion2 longitudinally through which is formed anaxial bore16. Through the axial bore16 passes thesuture12. Preferably, theaxial bore16 allows thesuture12 to move therethrough in one direction only, that is, away from the softtissue anchoring portion2. Structure to permit uni-directional movement of thesuture12 through the strongtissue anchoring portion4 may include, for example, ratchetteeth18 extending from diametrically opposite sides of thebore16 and radially into the bore to closely engage thesuture12, as shown inFIG. 3C. Theratchet teeth18 of one side are in mirrored symmetry to theratchet teeth18 of the other, and both are angled inwardly of thebore16 and away from the softtissue anchoring portion2. With such structure, thesuture12 may slip past theratchet teeth18 in one direction only, that is, away from the softtissue anchoring portion2, and theratchet teeth18 will exert a force or grip on thesuture12 to prevent its movement in the opposite direction (i.e., toward the soft tissue anchoring portion2).
• Thesupport plate8 of the softtissue anchoring portion2 also includes an exposed surface from which extend a plurality ofbarbs10 which are angled from the surface from which they extend at, again, preferably between about 30 degrees and about 60 degrees, and more preferably about 45 degrees. Also, depending on the surgical application, thebarbs10 of the strongtissue anchoring portion4 extend in a direction opposite to that of thebarbs10 of the softtissue anchoring portion2. Furthermore, thebarbs10 of the strongtissue anchoring portion4 are preferably smaller than those of the softtissue anchoring portion2.
• The softtissue anchoring portion2, with the relativelylarge barbs10, is designed for location in the soft tissues of the face and provides good “pullout” strength in fat, while the strongtissue anchoring portion4, with its relativelysmaller barbs10, is designed to be anchored in stronger tissues, such as the temporalis fascia, or beneath the periosteum. Either one or both of the softtissue anchoring portion2 and the strongtissue anchoring portion4 may be made from a resorbable material.
• The anchoringportions2,4 of the embodiment of the present invention shown inFIGS. 3A-3C may be surgically implanted in either an open, endoscopic or blind procedure. In the preferred procedure, the surgeon would use a trans-buccal approach under direct visualization to place the softtissue anchoring portion2 in the malar fat pad. More specifically, a hollow needle would be blindly inserted through the subcutaneous cheek tissue and up into the temple of the temporalis fascia through a small incision under direct visualization. Thesuture12 would then be adjusted until the fat pad is in the desired and appropriate position, and then it would be tied off. Alternatively, the temporalisfascia anchoring portion4 could incorporate a suture gripping means, such as theratchet teeth18 described previously, so that thesuture12 would not require a knot. Although theratchet teeth18 was described as one form of suture gripping means, it is envisioned that other means could be employed, including a pre-tied knot, a friction locking collar, a crimped-on staple or any other means known to secure a suture, filament, line, string or rope, for example, to a cleat, clamp or other securing device.
• A fourth embodiment of a tissue anchoring, relocating or reinforcing device formed in accordance with the present invention is shown inFIGS. 4 and 5. The “Part B” tissue engagement means4, i.e., a tissue anchoring portion that is located at the anchoring site, includes asupport plate8 having an exposed surface from which outwardly extends a plurality ofangled barbs10. Thebarbs10 are preferably angled to the same degree as previously described with respect to the other embodiments of the present invention. A single bore or two separate parallel bores16 extend longitudinally axially through the thickness of thesupport plate8. A pair ofsutures12 are received by and pass through the single or separate parallel bores16. Thissupport plate8 may include suture gripping means, such as theratchet teeth18 previously described, or a friction locking collar, crimped-on staple or other means to provide one-way movement of thesuture12 through the support plate of the tissue anchoring portion.
• A “Part A”tissue anchoring portion2, i.e., the one that is located at the site to be manipulated, is also included. This anchoringportion2 includes asupport plate8 having an exposed surface from which outwardly extends a plurality ofangled barbs10. Again, thebarbs10 extend preferably at the same preferred angle as thebarbs10 previously described with respect to the other embodiments of the present invention. Also, thebarbs10 extend from thesupport plate8 of the “Part A”tissue anchoring portion2 in a direction which is opposite to that of thebarbs10 of the “Part B”tissue anchoring portion4. Also, depending on the particular surgical procedure and application of the device, thebarbs10 of this anchoringportion2 may extend from a side of thesupport plate8 which is in an opposite facing direction to the side of thesupport plate8 of theother anchoring portion4 from which thebarbs10 extend. The twosutures12 are fixedly joined to thesupport plate8 of thistissue anchoring portion2.
• The “Part A”tissue anchoring portion2 is designed to grip strong tissues, such as ligaments and other connective tissue, tendons, muscle fascia and periosteal fascia, and the “Part B”tissue anchoring portion4 is designed to be anchored in other strong tissues, such as beneath the temporalis fascia. The twoanchoring portions2,4 are connected by thesutures12. In a test procedure that demonstrated the suitability of the fourth embodiment of the present invention for facial plastic surgery, the “Part A” anchoringportion2 was placed in a cadaver's maxillo-buccal ligament through an open approach. A small incision was made above the left ear of the cadaver, and forceps were inserted blindly subcutaneously through the cheek tissue of the patient; then, thesutures12 were brought through the cheek tissue. The “Part B” anchoringportion4 was inserted through a small open incision placed beneath the temporalis fascia, and thefirst anchoring portion2 was then adjusted by pulling thesutures12 and tying them off. The location and dissection path of the anchoring device of the present invention are shown inFIG. 5 of the drawings. It should be noted that the open dissection of the cheek tissue was only performed for experimental purposes. The preferred method of placement of the device is through an endoscopic tunnel that begins at the temporal incision.
• It is envisioned as part of the present invention to form the first tissue engagement means2, i.e., the “Part A” tissue anchoring portion, and the connection means6, the “Part C” component, or the second tissue engagement means4, i.e., the “Part B” tissue anchoring portion, and the “Part C” connection means6, as a single unitary piece. For example, if the connection means6 and the second tissue engagement means4 were formed from a mesh material, and the connection means6 and/or the first tissue engagement means2 were adjustable in distance from the second tissue engagement means4, then such a device may be suitable for use as a malar fat pad relocation device. Such a device formed in this manner is shown schematically inFIG. 6.
• More specifically,FIG. 6 shows an elongated connection means formed as astrip20 of mesh material which is connected to the second tissue engagement means4 (i.e., the “Part B” tissue anchoring portion), which is also formed from a mesh material. The secondtissue anchoring portion4 is shown in a “spider web” configuration, that is, generally round with concentrically disposedcircular strands22 joined to radially extendingstrands24. Of course, it is envisioned to be within the scope of the present invention to form the “Part B”tissue anchoring portion4 in other shapes and configurations from that which is shown inFIG. 6 and described previously. The elongated mesh connection means20 is attached to a “Part A” tissue engagement means2, or first tissue anchoring portion, which is used to attach and secure to the device soft tissue. The softtissue anchoring portion2 may be formed in a similar manner to those of the other embodiments of the present invention previously described such that it includes asupport plate8 having an exposed surface from which outwardly extends a plurality ofangled barbs10, thebarbs10 preferably extending from the surface of the support plate at an angle of preferably between about 30 degrees and about 60 degrees, and more preferably at about 45 degrees. Theelongated mesh strip20 which serves as the connection means may pass through abore16 which extends longitudinally axially through the center of thesupport plate8 of the softtissue anchoring portion2 and may engage gripping means inside the bore, such as theratchet teeth18 described with respect to the earlier embodiment shown inFIGS. 3A-3C, to allow a one-way movement of themesh connection strip20 through the softtissue anchoring portion2. Of course, other gripping means may be suitable for use with the present invention, such as a pre-tied knot formed in themesh connection strip20, a friction locking collar or a crimped-on staple or other means, such as described previously. Alternatively, no gripping means may be included, and the surgeon simply ties off with a knot the end of themesh connection strip20 as it passes through thesupport plate8 of the softtissue anchoring portion2.
• Thus, themesh connection strip20 could either be extendable or inextendable through the firsttissue anchoring portion2, depending on the desired characteristics of the device and the requirements of the surgeon for the particular surgical application. For example, if the device is made extendable (i.e., adjustable in length), and if the stiffiess of the device is tailored to the particular application, such as by using a thicker mesh or a mesh material which is less flexible, the device may be provided with properties that will exert a force on the tissue that will keep the tissue taut as it heals. An additional advantage of the second tissue anchoring portion (i.e., the “Part B” tissue engagement means4) being formed of a mesh material is that it will allow a much smaller entry profile for the device during surgical implantation, as it may be rolled up during the surgical procedure.
• Alternatively, the device of the present invention may be formed from two barbed anchoring portions (i.e., a “Part A” and “Part B” tissue engagement means2,4) interconnected by anelongated mesh strip20 serving as the “Part C” connection means6, as shown inFIG. 7 of the drawings. Each of the twobarbed anchoring portions2,4 preferably includes asupport plate8 having an exposed surface from which a plurality of angularly-disposedbarbs10 outwardly extend. Themesh connection strip20 may be fixedly joined to and between thesupport plate8 of each of the twobarbed anchoring portions2,4 or, alternatively, may pass through longitudinally axially extendingbores16 formed in one or both of thebarbed anchoring portions2,4 so that themesh connection strip20 can be adjusted with respect to one or both of the anchoringportions2,4 in order to adjust the distance between the anchoring portions during the surgical implantation procedure, in the same manner as described previously with respect to the embodiment shown inFIG. 6 of the drawings. Again, gripping means, such as described previously with respect to the embodiment shown inFIG. 6, may be included in one or both of thebarbed anchoring portions2,4 to permit only unidirectional movement of themesh connection strip20 in opposite directions through each respective anchoring portion. The embodiment shown inFIG. 7, having preferably an adjustablemesh connection strip20 with twobarbed anchoring portions2,4, could find utility in supporting the soft tissues of the neck.
• Another embodiment of the present invention is a variation of that shown inFIG. 6 of the drawings. In particular, this embodiment includes a barbed anchoring portion, defining a “Part A” soft tissue engagement means2, at one end of the device, a section ofmesh material26, such as the “spider web” configured structure of the embodiment shown inFIG. 6, as the second tissue anchoring portion (i.e., a “Part B” tissue engagement means4), and asuture12 interposed between and interconnecting the twotissue anchoring portions2,4. The softtissue anchoring portion2, again, may be formed with asupport plate8 having an exposed surface from which angularly extend a plurality ofbarbs10 to engage the soft tissue of the patient and may include a longitudinally axially extendingbore16 through which thesuture12 passes, and gripping means, such as ratchetteeth18 internal to the bore, such as described with respect to the embodiments shown inFIGS. 3A-3C to allow the distance between the anchoringportions2,4 to be adjusted by the surgeon pulling on the end of thesuture12 which passes through the softtissue anchoring portion2 of the device, with only one-way directional movement being permitted by the gripping means so that thesuture12, defining the connection means6, does not loosen and the selected distance between the two anchoringportions2,4 does not change after the surgical procedure has been completed. Again, other gripping means, such as described previously in the other embodiments, may be used in the device of the present invention shown inFIG. 7. Alternatively, no gripping means need be included, and the surgeon simply ties a knot in the end of thesuture12 which passes through the softtissue anchoring portion2 to prevent thesuture12 from slipping back through thebore16 of the anchoringportion2. This embodiment of the present invention shown inFIG. 7 is particularly useful in facial plastic surgery, because the profile of theconnection element6 is kept to a minimum and, therefore, the damage that needs to be done to implant the device is minimized.
• Another adjustable embodiment of the present invention is shown inFIGS. 9 and 9A of the drawings. Here, two barbed anchoring portions (i.e., a “Part A” and “Part B” tissue engagement means2,4), each preferably having asupport plate8 with an exposed surface from which outwardly and angularly extends a plurality ofbarbs10 to engage the tissue of the patient, are connected with a ratcheting connection element (i.e., the “Part C” connection means6). More specifically, either one of the two barbed anchoring portions (as shown inFIG. 9, for example, the “Part A” soft tissue engagement means2) may be fixedly joined to the connection element, and the other of the barbed anchoring portions (as shown inFIG. 9, for example, the “Part B” tissue engagement means4) may be adjustably joined to theconnection element6. Even more specifically, the “Part B” tissue engagement means4 preferably includes asupport plate8 having a plurality ofbarbs10 extending angularly and outwardly from an exposed surface thereof, and aslot28 formed longitudinally axially therethrough for receiving theratcheting connection element6, as shown inFIG. 9A. Extending at least partially into theslot28 formed in thetissue anchoring portion4 is aresilient pawl30.
• Theconnection element6 is preferably formed as a flexible or semi-flexible elongated thin strip of material having oppositelateral edges32 on at least one of which is formed a plurality ofratchet teeth34. As shown inFIG. 9A, theratchet teeth34 of theconnection element6 engages theresilient pawl30 of thetissue anchoring portion4 to allow the distance between the twobarbed anchoring portions2,4 to be adjusted by the surgeon pulling on the end of theconnection element6 which passes through theaxial slot28 of thetissue anchoring portion4. The engagement of thepawl30 with theratchet teeth34 permits only uni-directional movement of theconnection element6 through thetissue anchoring portion4 to prevent slippage of the connection element in an opposite direction so that the distance between the twotissue anchoring portions2,4 does not change after being adjusted by the surgeon to obtain the desired results. This avoids the need for the surgeon to tie knots in a suture when performing a tissue relocation procedure.
• FIG. 10 shows another embodiment of a device formed in accordance with the present invention for attaching, relocating or reinforcing tissue. In this particular embodiment, the connecting element (the “Part C” connection means6) may be formed as amesh36 or from a mesh material that hasmultiple arms38 extending in different directions. As shown inFIG. 10, themesh connecting element36 has threearms38 extending in three different directions to define a triangular web for supporting tissue, although it is envisioned to be within the scope of the present invention to provide a connectingelement36 that extends in more directions and havingmore arms38 than that shown inFIG. 10. Each of thearms38 of themesh connecting element36 is connected to arespective anchoring portion40 of the device, either a “Part A” tissue engagement means2 or a “Part B” tissue engagement means4. Also, each of thearms38 may be adjustably connected to one of thetissue anchoring portions40 so that appropriate tension is provided to the tissue supported by themesh connecting element36. Thetissue anchoring portions40 may be in the form of the barbed anchors previously described with respect to several other embodiments of the present invention, for example, one or the other of thetissue anchoring portions2,4 shown inFIGS. 3A-3C,FIG. 6 orFIG. 7. More specifically, each of thetissue anchoring portions40 may include asupport plate8 having an exposed surface from which angularly outwardly extend a plurality ofbarbs10, such as described previously, with thesupport plate8 having formed longitudinally axially therethrough abore16. Thearms38 of the connectingelement36 themselves may pass directly through theaxial bores16 of thesupport plates10 of thetissue anchoring portions40, or they may be connected tosutures12 which pass through thebores16 of thesupport plates10. Again, like the other embodiments, thetissue anchoring portions40 may include gripping means, such asratchet teeth18, formed in theaxial bore16 of theirrespective support plates40 to allow one-way adjustment of themesh connecting element36 and to prevent slippage thereof through the tissue anchoring portions. Or, alternatively, one or more of thearms38 of themesh connecting element36 may be fixedly joined to a respectivetissue anchoring portion40 of the device.
• The embodiment shown inFIG. 10 and described previously is particularly useful in supporting large structures, like the breast, during breast reduction surgery, or the vaginal vault during pelvic floor repair. In this latter case, two of thearms38 would be placed anterior and posterior to the vagina, in the space between the vagina and the urethra and the space between the vagina and the rectum respectively. The remainingarm38 would then be placed deep in the patient's body, to be anchored to the periosteum near the sacrum. More specifically,FIG. 13 illustrates the location of the device having amesh connection element36 withmultiple arms38 implanted in a patient to provide support to the vagina in pelvic organ prolapse repair. More specifically,FIG. 13 shows the preferred deployment of the embodiment ofFIG. 10, with themesh36 placed anterior and posterior to the vagina through a transvaginal incision or through an endoscopic approach, with theanchors40 set near the entroitus and into the sacrospinus ligament or the periosteum near the sacrum. Thearms38 of themesh connecting element36 are then adjusted by the surgeon to provide the appropriate placement of the vaginal vault.
• The embodiment of the present invention shown inFIG. 10 is also suitable for use for patients with congestive heart failure. In this situation, and as illustrated byFIG. 12 of the drawings, onetissue anchoring portion40 of the device would be placed at the apex of the heart, on the anterior surface, and the other twotissue anchoring portions40 would be placed in the atrio-ventricular septum, as shown inFIG. 12. The surgeon would then adjust themesh connecting element36 with respect to the anchoringportions40 until the appropriate level of ventricular volume change is achieved.
• Primarily, throughout this disclosure of the present invention, tissue anchoring portions of the device of the present invention, in the various embodiments, have been described as havingsupport plates8 withangular barbs10 extending therefrom, in order to facilitate an understanding of the present invention and to describe one form of tissue engagement means which is suitable for use. However, it is envisioned to be within the scope of the present invention to have tissue anchoring portions of the device formed with other structure that is capable of attaching to either soft or hard tissue.FIGS. 11A-11E show other forms of tissue engagement means2,4, either of the “Part A” or “Part B” type, that are suitable for use with the device of the present invention and are envisioned to be within the scope of the present invention.
• More specifically,FIG. 11A shows the tissue anchoring portion having asupport plate8 with angularly disposedbarbs10 extending from an exposed surface thereof, such as described previously with respect to many of the embodiments shown in the figures. Thesebarbs10 are shown to extend in the direction of the force applied, such as when the connecting element is tightened. The arrow F shown inFIG. 1 A denotes the direction of the force applied against the tissue anchoring portion, and the angle of thebarbs10 extending therefrom resists such force.
• FIG. 11 B shows an alternative form of a tissue anchoring portion, either of the “Part A” type or the “Part B” type. Here, the tissue anchoring portion may be formed as a plate-like structure42 which can be said to be tree-shaped in plan view, having oppositelateral edges44 with a plurality ofbarbs46 extending outwardly from eachlateral edge44. Unlike the “out of plane”barbs10 of the tissue anchoring portion shown inFIG. 11A, the tissue anchoring portion ofFIG. 1 B has “in plane”barbs46. Thebarbs46 extend angularly from the lateral edges44 in a direction toward the force F applied against the tissue anchoring portion to oppose such force exerted by the connectingelement6 joined to the tissue anchoring portion of the device.
• Alternatively, the tissue anchoring portion of the device may include “in plane” and “out of plane” barbs, such as shown inFIG. 11C. More specifically, a thin, flatplanar member48 having oppositelateral edges50, withbarbs52 extending angularly outwardly from the lateral edges50, as in the embodiment shown inFIG. 11B, may further have angularly protrudingbarbs54 extending outwardly from the opposite top andbottom sides56,58 of theplanar member48. Again, thebarbs52 formed on the lateral edges50 and thebarbs54 formed on the top andbottom sides56,58 are angularly disposed in the direction of the force F applied against the tissue anchoring portion in order to oppose such force.
• It is further contemplated that the tissue anchoring portions of the device could be T-shaped, such as shown inFIG. 11D, with outwardly extendinglegs60 joined to theconnection element6 which may be a suture or mesh or take on another form. Again, alternatively, the tissue anchoring portion may be in the form of a large bead orsphere62 at the end of the connection means6, such as shown inFIG. 11E, that prevents the tissue anchoring portion of the device from pulling through the tissue to which it is attached.
• Alternatively, thetissue anchoring portions2,4 of the device may be sewn in place, glued in place with a biocompatible adhesive, such as a fibrin glue, or implanted and fixed in position through the ingrowth of tissue. It is also possible to make the mesh connective element (the “Part C” connection means6), such as that shown inFIG. 9 of the drawings, self-adhesive by coating it with fibrin or thrombin and allowing it to “clot” into place.
• Furthermore, thetissue anchoring portions2,4 of the device of the present invention may be made out of a variety of materials, including resorbable plastics like PLA (poly lactic acid), PGA (poly glycolic acid) and polydioxanone, or non-resorbable plastics, such as nylon, polyester and others. Thetissue anchoring portions2,4, either one or both of the “Part A” or “Part B” type, may also be formed from a resorbable metal, such as magnesium, or permanent metals, such as stainless steel and nickel-titanium alloys.
• The connecting element (i.e., the “Part C” connection means6) which is interposed between the twotissue anchoring portions2,4 may be formed from sutures, a mesh, molded strips or metal. The materials of the connecting element could be selected to be resorbable, such as PLA, PGA, magnesium and others, or non-resorbable, such as stainless steel, nickel-titanium, titanium and others.
• Various applications of the device of the present invention for attaching, relocating or reinforcing tissue have been described herein. However, it should be understood that the invention is useful in a variety of procedures where the suspension or reattachment of soft tissue is required. These procedures include “facelift” procedures, particularly for the upper and midface, and other facial cosmetic surgery, such as neck and jowl lifts. The device of the present invention could also be used to provide support in breast surgery (e.g., breast lift or mastopexy), testicular lift procedures and repair of inguinal hernias. The device of the present invention may also be used to provide support to incompetent venous valves in patients suffering from varicose veins by wrapping the vein in the area of the valve and reshaping the valve until it closes appropriately.
• Although illustrative embodiments of the present invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention.

Claims (29)

1. A device for attaching, relocating or reinforcing tissue, which comprises:

at least two tissue engagement means, including a first tissue engagement means and a second tissue engagement means; and

connection means interposed between and interconnecting the first tissue engagement means and the second tissue engagement means.

2. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the connection means slidably engages at least one of the first tissue engagement means and the second tissue engagement means to allow the distance between the first tissue engagement means and the second tissue engagement means to be adjusted.

3. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein at least one of the first tissue engagement means and the second tissue engagement means includes a support plate having an exposed surface, and a plurality of barbs extending angularly outwardly from the exposed surface.

4. A device for attaching, relocating or reinforcing tissue as defined byclaim 3, wherein the barbs extend from the exposed surface of the support plate at an angle thereto of between about 30 degrees and about 60 degrees.

5. A device for attaching, relocating or reinforcing tissue as defined byclaim 3, wherein the barbs extend outwardly from the exposed surface of the support plate at an angle of about 45 degrees thereto.

6. A device for attaching, relocating or reinforcing tissue as defined byclaim 3, wherein the support plate further has formed longitudinally axially therethrough a bore for receiving the connection means therethrough.

7. A device for attaching, relocating or reinforcing tissue as defined byclaim 6, wherein the support plate includes ratchet teeth extending into the axial bore for engaging the connection means and to prevent movement of the connection means with respect to the support plate in at least one direction.

8. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein at least one of the first tissue engagement means and the second tissue engagement means includes gripping means for engaging the connection means and preventing movement of the connection means with respect to the at least one of the first tissue engagement means and the second tissue engagement means in at least one direction.

9. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the connection means includes at least one suture extending between the first tissue engagement means and the second tissue engagement means.

10. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the connection means includes a mesh structure extending between the first tissue engagement means and the second tissue engagement means.

11. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein at least one of the first tissue engagement means and the second tissue engagement means includes a mesh structure.

12. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein at least one of the first tissue engagement means and the second tissue engagement means includes a resilient pawl, and wherein the connection means includes an elongated member having opposite lateral sides, and ratchet teeth situated on at least one of the lateral sides, the resilient pawl of the at least one of the first tissue engagement means and the second tissue engagement means engaging the ratchet teeth of the connection means to prevent movement of the connection means with respect to the at least one of the first tissue engagement means and the second tissue engagement means in at least one direction.

13. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, which further comprises a third tissue engagement means, the connection means being interposed between and interconnecting the first tissue engagement means, the second tissue engagement means and the third tissue engagement means.

14. A device for attaching, relocating or reinforcing tissue as defined byclaim 13, wherein the connection means includes a mesh structure extending between the first tissue engagement means, the second tissue engagement means and the third tissue engagement means.

15. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the first tissue engagement means includes a first support plate having a first exposed surface, and a plurality of barbs extending angularly outwardly from the first exposed surface; and wherein the second tissue engagement means includes a second support plate having a second exposed surface, and a plurality of barbs extending angularly outwardly from the second exposed surface, the second support plate having formed longitudinally axially therethrough a bore for receiving the connection means therethrough.

16. A device for attaching, relocating or reinforcing tissue as defined byclaim 15, wherein the connection means is one of a mesh structure and at least one suture.

17. A device for attaching, relocating or reinforcing tissue as defined byclaim 16, wherein the second tissue engagement means includes gripping means for engaging the connection means and for preventing movement of the connection means with respect to the second tissue engagement means in at least one direction.

18. A device for attaching, relocating or reinforcing tissue as defined byclaim 15, wherein the second support plate includes a resilient pawl extending at least partially into the axial bore formed in the second support plate, and wherein the connection means includes an elongated member having opposite lateral sides, and ratchet teeth situated on at least one of the lateral sides, the resilient pawl of the second support plate engaging the ratchet teeth of the elongated member to prevent movement of the elongated member with respect to the second support plate in at least one direction.

19. A device for attaching, relocating or reinforcing tissue as defined byclaim 15, wherein the barbs of the first support member are larger that the barbs of the second support member.

20. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the first tissue engagement means includes a support plate having an exposed surface, and a plurality of barbs extending angularly outwardly from the exposed surface; wherein the second tissue engagement means includes a mesh structure; and wherein the connection means includes an elongated mesh strip interposed between and interconnecting the mesh structure of the second tissue engagement means and the support plate of the first tissue engagement means.

21. A device for attaching, relocating or reinforcing tissue as defined byclaim 20, wherein the support plate further has formed longitudinally axially therethrough a bore for receiving the elongated mesh strip of the connection means therethrough.

22. A device for attaching, relocating or reinforcing tissue as defined byclaim 1, wherein the first tissue engagement means includes a support plate having an exposed surface, and a plurality of barbs extending angularly outwardly from the exposed surface; wherein the second tissue engagement means includes a mesh structure; and wherein the connection means includes a suture interposed between and interconnecting the mesh structure of the second tissue engagement means and the support plate of the first tissue engagement means.

23. A device for attaching, relocating or reinforcing tissue as defined byclaim 22, wherein the support plate has formed longitudinally axially therethrough a bore for receiving the suture of the connection means therethrough.

24. A method of using a device for attaching, relocating or reinforcing tissue, which comprises the steps of:

attaching a first tissue engagement means of at least two tissue engagement means to tissue at a first location;

attaching a second tissue engagement means of the at least two tissue engagement means to tissue at a second location, the second location being different from the first location, a connection means being interposed between and interconnecting the first tissue engagement means and the second tissue engagement means; and

adjusting the connection means to change the distance between the first tissue engagement means and the second tissue engagement means.

25. A method of using a device for attaching, relocating or reinforcing tissue, which comprises the steps of:

implanting a first tissue engagement means of at least two tissue engagement means of the device in tissue at a first location; and

implanting a second tissue engagement means of the at least two tissue engagement means in tissue at a second location, the second location being different from the first location, the first tissue engagement means and the second tissue engagement means being connected to a connection means interposed between and interconnecting the first tissue engagement means and the second tissue engagement means.

26. A minimally invasive method for relocating a malar fat pad in a facial plastic surgery procedure performed on a patient, which comprises the steps of:

implanting a soft tissue anchor in the malar fat pad of the patient, the soft tissue anchor including a support plate having an exposed surface and a plurality of barbs extending angularly outwardly from the exposed surface, the soft tissue anchor being connected to a first portion of a suture;

inserting a hollow needle through the subcutaneous cheek tissue and up into the temple of the patient;

passing a second portion of the suture through the hollow needle to the temple of the patient;

removing the hollow needle from the suture;

mounting a strong tissue anchor to the suture at the second portion thereof, the strong tissue anchor including a support plate having an exposed surface and a plurality of barbs extending angularly outwardly from the exposed surface, and further having formed longitudinally axially therethrough a bore for receiving the second portion of the suture;

implanting the strong tissue anchor beneath the temporalis fascia of the patient through a small incision; and

adjusting the suture until the malar fat pad is situated in a desired location.

27. A method of using a device for attaching, relocating or reinforcing tissue as defined byclaim 14 to support a patient's vaginal vault in a pelvic floor repair surgical procedure, which comprises the steps of:

positioning the first tissue engagement means and the second tissue engagement means in locations that are anterior and posterior to the patient's vagina in the space between the vagina and the urethra and the space between the vagina and the rectum, respectively; and

positioning the third tissue engagement means at a location near the sacrum and securing the third tissue engagement means to the periosteum.

28. A method of using a device for attaching, relocating or reinforcing tissue as defined byclaim 14 for surgically treating patients with congestive heart failure, which comprises the steps of:

implanting the first tissue engagement means at a location at the apex of the heart and on the anterior surface thereof;

implanting the second tissue engagement means and the third tissue engagement means at locations in the atrio-ventricular septum of the heart; and

adjusting the mesh structure with respect to the first tissue engagement means, the second tissue engagement means and the third tissue engagement means until the desired level of ventricular volume change is achieved.

29. A method of using a device for attaching, relocating or reinforcing tissue as defined byclaim 14 in order to provide support to the vagina in pelvic organ prolapse repair, which comprises the steps of:

placing the mesh structure anterior and posterior to the vagina through a transvaginal incision or through an endoscopic approach;

implanting the first tissue engagement means, the second tissue engagement means and the third tissue engagement means at locations near the entroitus and into the sacrospinus ligament or the periosteum near the sacrum; and

adjusting the mesh structure to provide the appropriate placement of the vaginal vault.

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