Patent Grant
11992205
The present invention generally relates to devices and methods for repairing and stabilizing tissue and implants. Specifically, the present invention provides devices and methods for repairing, reconstructing, augmenting, and stabilizing joints of the body, and more particularly, the knee and joints of the spine (including intervertebral discs and adjacent bones).
During a surgical procedure, tissue is either intentionally or accidentally displaced, torn, or fractured to create a pathway to a desired operation site. In doing so, this tissue is damaged to a point where it may not function properly. After the intended surgical procedure or implantation is performed at the operation site, the skin incision is approximated. Currently, however, the other tissue like the muscles, ligaments, tendons, cartilage, bones, etc. which were damaged to create the pathway are not necessarily repaired or reconstructed. For example, following spinal surgery, a frequent complication is late instability where there is shearing antero-posteriorly or superior inferiorly due to excess motion because the ligaments have been damaged during surgical exposure. This complication may lead to degenerative disc disease and lower back pain.
Various methods and devices have been disclosed for repairing tissue. For example, U.S. Pat. No. 6,425,919 issued to Lambrecht discloses a disc herniation constraining device for implantation into the disc. The constraining device includes a fastener, a barrier, and a support member connecting the fastener and barrier. The barrier closes a defect in the annulus of the disc, while the fastener supports the position of the barrier. The barrier is placed between the annulus and the nucleus of the disc. The barrier may include a sealant and an enlarger.
In another example, U.S. Pat. No. 6,592,625 issued to Cauthen discloses a collapsible patch which is inserted through a surgical incision or rupture of the annulus. The patch is positioned within the subannular space. The patch expands to bridge the incision or rupture thereby occluding the aperture from the interior of the disc and preventing migration of nucleus pulposus.
U.S. Pat. No. 6,679,889 issued to West, Jr. et al discloses a method and apparatus of repairing the anterior cruciate ligament. The device enables the surgeon to independently apply a desired tensile load onto individual strands of a multiple-stranded soft tissue graft. The device is equipped with structure for fastening or otherwise attaching the device to a patient's limb during the conditioning and pre-tensioning procedure.
Additionally, U.S. Pat. No. 6,699,286 issued to Sklar discloses methods and apparatus of making repairs with graft ligaments. The method for graft ligament reconstruction includes harvesting a graft ligament consisting entirely of soft tissue. The graft ligament is compacted through compression so as to significantly reduce the cross-sectional area and increase the density of the collagen material of the graft ligament. The compressed graft ligament is deployed within the human body.
Various methods and devices have been disclosed for inserting an implant within the body. For example, U.S. Pat. No. 5,108,438 issued to Stone discloses a mesh skirt to anchor a prosthetic intervertebral disc. The implant includes a dry, porous, volume matrix of biocompatible and bioabsorbable fibers which may be interspersed with glyscosaminoglycan molecules. The matrix is adapted to have an outer surface contour substantially the same as that of a natural intervertebral disc. A mesh member extends from the lateral surface of the implant. After implantation, the mesh member may be sutured to adjacent tissue to anchor the disc in place. The mesh member may function in this capacity until sufficient tissue ingrowth occurs to provide that function.
In another example, U.S. Pat. No. 6,733,531 issued to Trieu discloses a spinal implant which is anchored using a device having an elongated anchoring body, such as an anchoring rod, and at least one securing member attached to the anchoring rod. The anchoring body or rod is configured to anchor, hold, or otherwise retain a spinal implant. The securing members are spaced apart along the length of the anchoring rod and may define a region for disposing an implant therebetween. The anchoring rod has a first end and a second end, wherein the first end is securable to an adjacent vertebra.
Once tissue has been repaired or an implant has been inserted within the body, the repaired region and surrounding tissue may be stabilized to enhance healing. U.S. Pat. No. 6,652,585 issued to Lange discloses a spine stabilization system including a flexible member attachable to a portion of the spinal column. The member includes components that are oriented and function similar to the natural fiber orientation of the anterior longitudinal ligament and annulus tissue. The use of components resist loading applied by extension and rotation of the spine, while the flexibility of the member does not subject it to the compressive loading of the spinal column segment to which it is attached.
In addition, U.S. Pat. No. 6,293,949 issued to Justis et al. discloses a device for stabilizing the spinal column. The device includes a longitudinal member sized to span a distance between at least two vertebral bodies and being at least partially formed of a shape-memory material exhibiting pseudoelastic characteristics at about human body temperature. The longitudinal member is reformed from an initial configuration to a different configuration in response to the imposition of stress caused by relative displacement between the vertebral bodies, and recovers toward the initial configuration when the stress is removed to thereby provide flexible stabilization to the spinal column.
There exists a need for devices and methods for repairing, reconstructing, augmenting, and securing tissue or an implant during surgery and “on the way out” after surgery has been performed at an intended operation site. Upon completion of the intended surgery, tissue may be compressed to other tissue or an implant to improve healing. Hard tissue, for example, may require rigid fixation while soft tissue to require flexible fixation. The repair, reconstruction, and augmentation of tissue and the securing of implants “on the way out” of the body after performing a surgical procedure creates a stabilized and enhanced healing environment.
The present invention provides for the repair, reconstruction, augmentation, and securing of tissue or implants during a surgical procedure and “on the way out” after the surgical procedure has been performed. Hard and soft tissue at and around the operation site and tissue between the operation site and the skin incision may be compressed and/or rebuilt so that tissue-function may be at least partially restored and the operation region may be stabilized for enhanced healing. This could be ligament repair, tendon repair, muscle repair, bone repair, cartilage repair, and repair of any other tissue type. Ligaments may be fastened to ligaments; ligaments to bones; bones to bones; ligaments to muscles; muscles to muscles; tissue grafts to bone; tissue grafts to ligaments; grafts to grafts; and any other combination of tissue and implants. It is further contemplated that the methods and devices of the present invention may be utilized with minimally invasive techniques.
In accordance with one aspect of the present invention, a method for stabilizing a body joint is provided. A fastener is positioned in contact with first body tissue on one side of the joint. Another fastener is positioned in contact with second body tissue on the other side of the joint. A suture is placed between the fasteners and tensioned. The tensioned suture is secured to the fasteners to restrict normal movement of the joint. The fasteners may be positioned in contact with the outer surface of the body tissues or inside of the body tissues. The suture may be positioned adjacent to the joint, through the joint, or in combination.
The body tissues may be bones, muscles, ligaments, tendons, nerves, skin, organs, cartilage, fascia, and blood vessels. The bones and ligaments may be bones and ligaments of the knee, ankle, elbow, wrist, feet, hand, hip, shoulder, jaw, and spine. Specifically, bones of the knee may include the femur, tibia, and patella. Ligaments of the knee may include the medial collateral ligament, lateral collateral ligament, posterior oblique ligament, arcuate ligament, oblique popliteal ligament, anterior cruciate ligament, and posterior cruciate ligament. Bones of the spine may include transverse process, pedicle, facet, spinous process, posterior arch, odontoid process, posterior tubercle, lateral articular process, uncinate process, anterior tubercle, carotid tubercle, odontoid process, lamina, and vertebral body. Ligaments of the spine may include the anterior longitudinal ligament, posterior longitudinal ligament, interspinous ligaments, supraspinous ligament, ligamentum flavum, intertransverse ligament, facet capsulary ligament, ligamentum nuchae, and ligaments of the sacrum and coccyx spine.
A tubular member may be positioned between the fasteners, and the suture may be placed within the tubular member such that a portion of the tubular member contacts the first body part and another portion of the tubular member contacts the second body part thereby maintaining the body parts in alignment with each other.
In accordance with another aspect of the present invention, there is provided a method for approximating an incision in tissue. A suture is positioned in portions of tissue located on opposite sides of the incision. The proximal and distal ends of the suture extend from the tissue and are adjacent the incision. A fastener is placed transverse to the incision with the ends of the suture disposed within at least one channel of the fastener. The suture is tensioned and secured to the fastener to thereby approximate the incision. The tissue may be bone, muscle, ligament, tendon, skin, organ, cartilage, and blood vessels.
Additionally, two fasteners may be positioned generally parallel to an incision with the first fastener placed on one side of the incision and the second fastener placed on the opposite side of the incision. A suture may be positioned in portions of tissue located on opposite sides of the incision with the middle section of the suture slidably disposed within at least one channel of the first fastener and the end portions of the suture disposed within at least one channel of the second fastener. The suture may be tensioned and secured to the fasteners to thereby approximate the incision.
In accordance with another aspect of the present invention, a fastener is provided. The fastener includes an elongated member and at least one channel extending therethrough generally perpendicular to the longitudinal axis of the elongated member. A portion of the outer surface of the fastener may be concave, flat, and/or convex.
There is also provided a method of using a fastener. At least a portion of the surface of the fastener is placed in contact with tissue. The fastener may be placed in contact with an outer surface of the tissue and/or the inner portion of the tissue. A portion of the surface of the fastener may be flat, convex, or concave. A convex portion of the fastener may be placed in contact with a concave portion of the tissue. A flat portion of the fastener may be placed in contact with a flat portion of the tissue. A concave portion of the fastener may be placed in contact with a convex portion of the tissue. In these configurations, the shaped portions of the fasteners mate with the tissue.
In accordance with yet another aspect of the present invention, a fastener assembly is provided. The assembly includes a plurality of fastener members, each fastener member having at least one channel extending therethrough. A plurality of connecting members links the fastener members to each other. The fastener members may be linked together end to end, side to side, or end to side. When linked together, the fastener members may form a linear, circular, rectangular, J, L, or U configuration. The connecting members may be hinges, pins, ball and socket, interconnecting loops, hooks, flexible filaments and/or rigid members. There may be two or more connecting members which link adjacent fastener members. The channels of the fastener members may be generally transverse to the longitudinal axis of the fastener member. Each fastener member may include two or more channels, and the channels may be generally parallel to each other.
Furthermore, a fastener strip or assembly is provided. The fastener strip or assembly includes a plurality of fastener members disposed on a flexible strip. Each fastener member has at least one channel extending therethrough. The channel may be generally transverse to the longitudinal axis of the fastener member. The fastener members are positioned on the flexible strip to form a linear, circular, rectangular, J, L, and/or U configuration. The fastener members may be affixed to the upper surface of the flexible strip. The fastener members may be affixed to the upper surface of the flexible strip with adhesive. The flexible strip may also have adhesive on its lower or bottom surface for adhesion to tissue. Such adhesives may include cyanoacrylate adhesives, hydrogel adhesives, monomer and polymer adhesives, fibrin, polysaccharide, Indermil® or any other biocompatible adhesive. The flexible strip may be bioabsorbable, bioerodible, degradable, biodegradable, expandable, and/or hydrophilic.
There is also provided a method for using a fastener assembly. The fastener assembly is positioned against tissue. A suture or sutures are positioned within the tissue and through the suture assembly to secure the assembly to the tissue. In one embodiment, the assembly is placed over an incision in the tissue. The fastener members are positioned such that channel of the fastener members are located on each side of the incision. A suture or sutures are positioned within the portions of tissue on opposite sides of the incision and through the fastener assembly. The suture or sutures are tensioned and secured with the fastener members. The type and configuration of the fastener assembly is determined with respect to the shape or configuration of the tissue. The shape of the incision also determines the shape of the fastener assembly.
In accordance with a further aspect of the present invention, a total disc replacement implant is provided. The implant includes a superior or upper portion made of a rigid material. The upper surface of the superior portion is configured to adjoin to a cut portion of a superior or upper vertebra. The implant also includes an inferior or lower portion made of a rigid material. The lower surface of the inferior portion is configured to adjoin to a cut portion of an inferior or lower vertebra. The implant further includes a middle portion made of a flexible material. The middle portion is affixed to the lower surface of the superior portion and the upper surface of the inferior portion.
The superior and inferior portions of the implant may include polymeric, composite, metallic, ceramic, and expandable material. The portions may also include synthetic bone and body tissue like bone, collagen, cartilage, and ligaments. The portions may also be bioabsorbable, bioerodible, degradable, and biodegradable. The middle portion of the implant may include rubber, gel, foam, polymer, collagen, and body tissue. The total disc replacement implant may be made of a plurality of components; that is, the implant may be modular. The components may be connected with each other to form the implant. The components may mechanically interlock with one another. Each component may have a size approximately the same as the length of the incision through which the components are inserted.
In addition, there is provided a method for total disc replacement. An incision is made through tissue for access to the spine. The dimensions of the incision may be minimized to reduce trauma to surrounding tissue like muscle, ligaments, tendons, and cartilage. The vertebra located superior to the damaged disc being replaced is cut. The cut may be made on the lower or bottom portion of the superior vertebra. The cut may be planar or multiplanar. The superior vertebra may be cut without disturbing or at least minimally disturbing the adjacent ligaments, cartilage, and muscles. The cut may be angled to avoid damaging or loosening the spinal ligaments like the anterior and posterior longitudinal ligaments.
The vertebra located inferior to the disc being removed is cut in a similar manner, except the upper surface of the inferior vertebra is cut. Once cut, the cut portions of vertebrae and the intervertebral disc are removed through the incision. The cut vertebrae are further prepared for receiving an implant. The total disc replacement implant or modular implant is positioned between the cut superior and inferior vertebrae. A modular implant may be positioned one component at a time or already assembled. The implant is anchored to the surrounding tissue like the adjacent vertebral bodies. Any ligaments, muscles, cartilage, tendons, or other body tissue cut or damaged during the procedure is repaired prior to closing the incision. Finally, the incision is approximated.
In accordance with another aspect of the present invention, a tissue alignment sleeve is provided. The sleeve includes a tubular member having a wall. The interior surface of the wall is generally smooth. The exterior surface of the wall includes means for gripping and creating friction. The gripping means may include threads, a plurality of raised regions, and a plurality of circumferential elevated areas or rings. The wall may include a plurality of openings for tissue ingrowth and outgrowth. The wall may include one or more longitudinal slits such that the tubular member or sleeve may be bendable to increase and decrease the diameter of the sleeve.
There is further provided a method of using a tissue alignment sleeve. A channel is created in tissue. The sleeve is positioned within the tissue. The gripping or friction means of the sleeve holds the sleeve within the tissue. The tissue may include first and second portions. When positioned within the first and second portions of the tissue, the portions are aligned and maintained in position relative to each other. The first and second portions may be portions of bone on opposite sides of a fracture. The portions may be tissue of a body joint. The portions may be bones of a joint located on opposite sides of the joint, such that when the sleeve is positioned, movement of the joint is restricted.
A sleeve with at least one longitudinal slit may be positioned with the channel created in tissue. The diameter of the sleeve may be decreased by closing the gap in the longitudinal slit. In a decreased diameter, the sleeve may be inserted into the channel. Once positioned, the diameter of the sleeve may be increased thereby engaging the gripping means with the tissue. A suture or sutures may be placed through the lumen of the sleeve to secure tissue located at the ends of the sleeve. After the sleeve has gripped the adjacent tissue with the gripping means, therapeutic substances or graft material (autogenic, allogenic, xenogenic, or synthetic) may be packed into the tubular member.
In accordance with a further aspect of the present invention, a method for stabilizing an implant is provided. A first fastener is positioned in contact with tissue located adjacent the implant. A second fastener is positioned in contact with tissue located adjacent the implant generally opposite the first fastener. A suture is placed between the fasteners and in contact with the implant. The suture is tensioned, and the fasteners are secured to the tensioned suture such that the suture transmits force to the implant. The suture may be positioned in contact with the surface of the implant. The suture may also be positioned within the implant.
In addition, a method for stabilizing an implant within a body is provided. A first fastener is positioned in contact with the implant. A second fastener is positioned in contact with tissue located adjacent the implant. A suture is placed between the fasteners. The suture is tensioned, and the fasteners are secured to the tensioned suture to anchor the implant to the tissue. The first fastener may be positioned within the implant or on the surface of the implant. The suture may be placed against or within the implant.
In accordance with another aspect of the present invention, there is provided a method for anchoring an implant for directional expansion within the body. A first fastener is positioned in contact with the first side of an expandable implant. A second fastener is positioned in contact with tissue located adjacent a second side of the implant which is opposite the first side. A first suture is positioned between the fasteners and tensioned. The first suture is secured with the first and second fasteners. In this configuration, the first side of the expandable implant is restricted from expanding, but all other sides of the implant can expand.
For further restriction of expansion, a third fastener is positioned in contact with the second side of the implant. A fourth fastener is positioned in contact with tissue located adjacent the first side of the implant. A second suture is positioned between the third and fourth fasteners. The second suture is tensioned and secured with the fasteners. The second side of the implant is restricted from expanding. To further restrict expansion of the implant, more fasteners and sutures may be positioned as previously described such that the implant is limited to expansion in one, two, or more directions.
The sutures may be positioned in contact with the expandable implant such that the sutures transmit force to the implant thereby anchoring the implant and further restricting expansion.
In accordance with a further aspect of the present invention, a device for anchoring an implant is provided. The device includes a pouch dimensioned and configured for receiving an implant. The pouch has an access port for inserting the implant. At least one anchoring point is connected with the pouch. The device may further include a flap attached to the pouch for closing the access port. The implant may be expandable, and when positioned in the pouch, the implant generally expands primarily in the direction of the access port. The pouch may include a plurality of access ports. An expandable implant placed in a pouch with a plurality of access ports expands primarily in the directions of the access ports.
In accordance with another aspect of the present invention, there is provided a method for repairing a ligament. A fastener is positioned in contact with the ligament adjacent the first side of a damaged region of the ligament. Another fastener is positioned in contact with the ligament adjacent a second side of the damaged region which is generally opposite the first side. A suture is positioned between the fasteners. The suture is tensioned and secured with the fasteners such that the ligament is tightened. The suture may be positioned through the ligament. The suture may also be positioned through tissue adjacent the damaged area. The tissue may be spine tissue such as one or more vertebrae and one or more intervertebral discs. The ligament may be a ligament of the spine such as the anterior or posterior longitudinal ligament, or any of the previously identified ligaments. The damaged region may be a loosened ligament area, a torn ligament area, or a missing ligament area.
Furthermore, a method for reconstructing a ligament is provided. A tissue graft is positioned adjacent a damaged region of the ligament. A first fastener is positioned in contact with the tissue graft on a first side of the damaged region. A second fastener is positioned in contact with the tissue graft on a second side of the damaged region which is generally opposite the first side. A suture is positioned between the fasteners with the suture passing through the tissue graft and ligament. The suture is tensioned and secured with the fasteners to hold the tissue graft against the ligament. The tissue graft may include ligamentous tissue or bone tissue. The ligament may be a ligament of the spine. The suture may be positioned within tissue located adjacent the ligament. The tissue may be spine tissue including one or more vertebrae and one or more intervertebral discs.
Moreover, there is provided another method for reconstructing a ligament. A tissue graft is positioned adjacent a damaged region of the ligament. A first fastener is positioned in contact with the tissue graft on a first side of the damaged region. A second fastener is positioned in contact with tissue adjacent the ligament. A suture is positioned between the fasteners with the suture passing through the tissue graft and ligament. The suture is tensioned and secured to the fasteners such that at least a portion of the tissue graft is held to the ligament. The tissue graft may include ligamentous tissue or bone tissue. The ligament may be a ligament of the spine like the anterior or posterior longitudinal ligament. The suture may be positioned within the tissue adjacent the ligament. The tissue may be spine tissue including one or more vertebrae and one or more intervertebral discs.
A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:
The devices and methods of the present invention provide for the repair, reconstruction, augmentation, and securing of tissue and/or implants during a surgical procedure and “on the way out” after the surgical procedure has been performed but before the skin incision has been closed. Tissue at and around the operation site and tissue between the operation site and skin incision is rebuilt so that tissue-function may be at least partially restored and the operation region may be stabilized for enhanced healing.
The devices used to repair, reconstruct, augment, and/or secure tissue or implants may be any biocompatible fastener described herein or found in the prior art. Examples of fasteners, implants, and their methods of employment may be found in U.S. Pat. Nos. 5,163,960; 5,403,348; 5,441,538; 5,464,426; 5,549,630; 5,593,425; 5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073; 5,845,645; 5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,086,593; 6,099,531; 6,159,234; 6,368,343; 6,447,516; 6,475,230; 6,592,609; 6,635,073; and 6,719,765. Other fastener types are disclosed in U.S. patent application Ser. Nos. 10/102,413; 10/228,855; 10/779,978; 10/780,444; and Ser. No. 10/797,685. The above cited patents and patent applications are hereby incorporated by reference.
The fasteners may be, but are not limited to, degradable, biodegradable, bioerodible, bioabsorbable, mechanically expandable, hydrophilic, bendable, deformable, malleable, riveting, threaded, toggling, barded, bubbled, laminated, coated, blocking, pneumatic, one-piece, multi-component, solid, hollow, polygon-shaped, pointed, self-introducing, and combinations thereof. Also, the fasteners may include, but are not limited to, metallic material, polymeric material, ceramic material, composite material, body tissue, synthetic tissue, hydrophilic material, expandable material, compressible material, heat bondable material, and combinations thereof.
The fasteners of the present invention may be linear fixation fasteners. Such fasteners secure tissue or an implant with access to only one side of the tissue or implant. Generally, the fastener is advanced through the tissue or implant, usually through a pre-made passage or without a passage when the fastener is self-introducing. Once placed through the tissue or implant, a distal portion of the fastener expands, biases outward, or changes configuration such that the distal portion prevents the fastener from being pulled back out of the tissue or implant. The proximal portion of the fastener is secured thereby anchoring the tissue or implant. Examples of linear fixation fasteners are further disclosed in the incorporated references.
The methods and devices of the present invention may be used in conjunction with any surgical procedure of the body. The repair, reconstruction, augmentation, and securing of tissue or an implant may be performed in connection with surgery of a joint, bone, muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, or other body part. For example, tissue may be repaired, reconstructed, augmented, and secured during and “on the way out” following intervertebral disc surgery, knee surgery, hip surgery, organ transplant surgery, bariatric surgery, spinal surgery, anterior cruciate ligament (ACL) surgery, tendon-ligament surgery, rotator cuff surgery, capsule repair surgery, fractured bone surgery, pelvic fracture surgery, avulsion fragment surgery, hernia repair surgery, and surgery of an intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor tendons, etc.
Also, tissue may be repaired after an implant has been inserted within the body. Such implant insertion procedures include, but are not limited to, partial or total knee replacement surgery, hip replacement surgery, bone fixation surgery, etc. The implant may be an organ, partial organ grafts, tissue graft material (autogenic, allogenic, xenogenic, or synthetic), collagen, a malleable implant like a sponge, mesh, bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal, polymer, composite, or ceramic. Other implants include breast implants, biodegradable plates, porcine or bovine patches, metallic fasteners, compliant bearing for medial compartment of the knee, nucleus pulposus prosthetic, stent, tissue graft, tissue scaffold, biodegradable collagen scaffold, and polymeric or other biocompatible scaffold. The scaffold may include fetal cells, stem cells, embryonal cells, enzymes, and proteins.
The present invention further provides flexible and rigid fixation of tissue. Both rigid and flexible fixation of tissue and/or an implant provides compression to enhance the healing process of the tissue. A fractured bone, for example, requires the bone to be realigned and rigidly stabilized over a period time for proper healing. Also, bones may be flexibly secured to provide flexible stabilization between two or more bones. Soft tissue, like muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly fastened for proper healing. Flexible fixation and compression of tissue may function as a temporary strut to allow motion as the tissue heals. Furthermore, joints which include hard and soft tissue may require both rigid and flexible fixation to enhance healing and stabilize the range of motion of the joint. Flexible fixation and compression of tissue near a joint may provide motion in one or more desired planes. The fasteners described herein and incorporated by reference provide for both rigid and flexible fixation.
Exemplary Fasteners
The following Examples 1 through 8 which illustrate uses of the present invention are for illustrative purposes and are not limiting examples. As mentioned above, any fastener disclosed herein or incorporated by reference may be used with the exemplary methods. To simplify the disclosure of the present invention, a limited number of fastener types will be used to illustrate the exemplary methods. For example, the fasteners disclosed in U.S. Pat. No. 5,921,986 will be used to represent any disclosed or known fastener.
As described in the above-mentioned patent, the fasteners may be placed against tissue, and a suture may be looped through the tissue with the ends of the suture positioned within the fasteners. The suture is tensioned, and the ends of the suture are secured using a knot or any other suitable means for maintaining the tension of the suture between the fasteners. The tensioning of the suture, or similar cable, pin, thread, etc., may be controlled and monitored with sensor technology, like a magnetic sensor, which may unload the pressure if necessary. Other known tensioning apparatus may also be utilized. For example, the tensioning system may be spring loaded, pneumatic, electrical, pisoelectric, and magnetic. The tensioning system may be connected with an introducer or cannula or may be part of a fastener or implant. The tensioning system may include a read-out display outside the body. The read-out display may receive tension data through radiofrequency energy, infrared energy, or other suitable energy source.
Additionally, two or more fasteners may be utilized to secure body tissue and/or an implant. When two fasteners are used, one fastener is placed against or within one tissue area and the second fastener is placed against or within another tissue area. The suture is looped through one fastener while the ends of the suture are positioned within the second fastener. The suture is tensioned and the ends fastened with a knot or fastened using a device or method disclosed herein or incorporated by reference. In this configuration, the suture includes two generally parallel legs or portions located between the fasteners. Furthermore, when two fasteners are used, a single suture may be employed leaving only one leg between the fasteners. In this configuration, each end of the suture is positioned in different fasteners. The suture may be tensioned and the ends secured. It is further contemplated that the fasteners and sutures may be inserted through a passage in the tissue or implant. For example, a passage may be drilled through tissue or implant for insertion of the fastener or suture. With the fastener in place, these passages may be packed or filled with tricalcium phosphate (TCP), calcium phosphate, a thermal polymer, polymethyl methacrylate (PMMA) with hydroxyaptite (HA), polylactic acid (PLA) with HA, and other suitable materials. These materials may harden within the passage and would provide additional stabilization of the tissue or implant.
Although the exemplary fasteners have been described as generally longitudinal members, it is also contemplated that the fasteners can take the form of a square, oval, sphere, button, or any other suitable configuration.
Alternatively, the fastener members 30e may be connected with one another with a flexible strip 50. As seen in
The flexible strip 50 may also include an adhesive on one side to adhere the fastener members 42 to the strip 50 and may further include adhesive of the other side to adhere the strip 50 to tissue or implant. Such adhesives may include cyanoacrylate adhesives, hydrogel adhesives, monomer and polymer adhesives, fibrin, polysaccharide, Indermil® or any other biocompatible adhesive.
The type and shape of the incision determine the size and configuration of the fastener assembly used. For example, a U-shaped incision could be closed with a U-shaped fastener assembly 30h, and an L-shaped incision could be closed with an L-shaped fastener assembly 30g. The suture or sutures used with the fastener assemblies may be tensioned and secured with a knot, or alternatively may be secured with devices and methods described herein and those incorporated by reference.
The exemplary fasteners may be utilized with one or more sutures, filaments, cables, or other similar implant. Generally, one suture may be used for the fasteners of
The exemplary fasteners and fastener assemblies of the present invention may be formed of any natural or artificial material. For example, they may be formed from material which is polymeric, metallic, composite, ceramic, or combinations thereof. Furthermore, the fasteners and assemblies may be made of body tissue including bone, collagen, cartilage, ligaments, or tissue graft material like xenograft, allograft, and autograft. They may be bioabsorbable, bioerodible, degradable, biodegradable, mechanically expandable, hydrophilic, and combinations thereof. The fasteners and assemblies may be made from a porous matrix or mesh of biocompatible and bioresorbable fibers acting as a scaffold to regenerate tissue.
The fasteners and assemblies may also be made of or have a coating made of an expandable material. The material could be compressed then allowed to expand once sutured to tissue or an implant. Alternatively, the fastener and assembly material could be hydrophilic and expand when it comes in contact with liquid. Examples of such expandable materials are desiccated body tissue, foam, and expandable polymers.
Furthermore, the fasteners, fastener assemblies, and implants described herein and incorporated by reference may include therapeutic substances to promote healing. These substances could include antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein (BMP), demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, germicides, fetal cells, stem cells, enzymes, proteins, hormones, cell therapy substances, gene therapy substances, and combinations thereof. These therapeutic substances may be combined with the materials used to make the fasteners to produce a composite fastener or implant. Alternatively, the therapeutic substances may be impregnated or coated on the fastener or implant. Time-released therapeutic substances and drugs may also be incorporated into or coated on the surface of the fastener or implant. The therapeutic substances may also be placed in a bioabsorbable, degradable, or biodegradable polymer layer or layers.
The sutures of the present invention may be made of metallic material, non-metallic material, composite material, ceramic material, polymeric material, copolymeric material, or combinations thereof. The sutures may be degradable, biodegradable, bioabsorbable, or non-biodegradable. Examples of suture materials are polyethylene, polyester, cat gut, silk, nylon, polypropylene, linen, cotton, and copolymers of glycolic and lactic acid. In an exemplary embodiment, the sutures are flexible or bendable. They may be threadlike, monofilament, multifilament, braided, or interlaced. The sutures may have a coating of therapeutic substances or drugs. For example, the sutures may include antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides.
The tubular member may be flexible to enable the tubular member to be inserted into a nonlinear passage through the bone. The tubular member may be formed of metallic material, composite material, ceramic material, polymeric material, or combinations thereof. The tubular member may be made from a degradable, biodegradable, bioerodible, or bioabsorbable material, such as a polymer, composite, or ceramic. The tubular member may also include a therapeutic substance to form a composite tubular member, or the therapeutic substance may be coated onto the tubular member. Furthermore, therapeutic substances or graft material (autogenic, allogenic, xenogenic, or synthetic) may be packed into the tubular member.
Additionally, the outer surface 58 of the tubular member 52 may include a friction or gripping means.
It is further contemplated that tissue and implants may be secured with biologic adhesive, or fasteners disclosed herein and incorporated by reference may be used with the biologic adhesive. Such adhesives may include cyanoacrylate adhesives, hydrogel adhesives, monomer and polymer adhesives, fibrin, polysaccharide, Indermil® or any other biocompatible adhesive. For example, tissue scaffolds and tissue welding fasteners disclosed herein or incorporated by reference may be used with adhesive and an energy source, like ultrasound, RF, laser, electromagnet, ultraviolet, infrared, electro-shockwave, or other suitable energy source, to activate or deactivate the adhesive.
As previously described, the present invention provides devices and methods for fastening body tissue and/or an implant. One example is the fastening or repair of ligamentous tissue. Ligamentous tissue is found, among other locations, within intervertebral discs of the spinal column. The spinal column is formed from a number of vertebrae which are separated from each other by intervertebral discs. The intervertebral discs stabilize and distribute force between the many vertebrae. As used herein, “spinal joint” or joint of the spine includes this intervertebral space.
Generally, intervertebral discs are made of a soft, central nucleus pulposus surrounded by a tough, woven annulus fibrosus. Herniation of a disc is a result of a weakening in the annulus. Symptomatic herniations occur when weakness in the annulus allows the nucleus pulposus to bulge or leak posteriorly toward the spinal cord and major nerve roots. One treatment of a herniated, displaced, or ruptured intervertebral disc is a discectomy. This procedure involves removal of disc materials impinging on the nerve roots or spinal cord posterior to the disc. Depending on the surgeon's preference, a varying amount of nucleus pulposus is removed from within the disc space either through the herniation site or through an incision in the annulus. In addition to a discectomy, other surgical procedures where the present invention may be used include a vertebroplasty and kyphoplasty.
One or more additional incisions 86 in the annulus 88 may be necessary for increased access to the nucleus 90. These other incisions will also need to be approximated. As seen in
While the incisions of
It is further contemplated that access to the nucleus pulposus may be obtained through a vertebral body. A channel(s) or passage(s) 92 may extend from the outer side surface of the vertebral body to the adjacent nucleus. The channel may be formed with a bone drill bit and/or a tissue harvesting device as described in U.S. Pat. No. 5,269,785 entitled Apparatus and Method for Tissue Removal, which is hereby incorporated by reference. The nucleus pulposus material may be fully or partially removed through the channel 92. Means for removing the material may include suction, scrapper, scooper, syringe, or other similar device. When no new material is required to be implanted in the region where the nucleus pulposus material was removed, the physician may close the channel 92 with graft material such as autograft material, allograft material, and/or other implantable materials disclosed herein. Alternatively, a plug/seal 93 made of metal, polymer, composite, or ceramic may be inserted into the channel 92 at either end of the channel or at both ends of the channel. The plug 93 may be removable for gaining access to the nucleus pulposus during a subsequent surgery. In this method, the annulus fibrosus is not incised, punctured, or weakened thereby reducing the healing time of the disc.
Depending on the severity of herniation or damage to the disc, nucleus pulposus replacement material or a nucleus pulposus prosthesis may be positioned between a superior vertebra and inferior vertebra. One or more incisions may be made through the annulus for access to the nucleus. The nucleus pulposus may be removed, and the replacement material or prosthesis may be inserted. Alternatively, the nucleus pulposus also remain in place with the replacement material or prosthesis positioned next to or along with the existing nucleus pulposus. Furthermore, the nucleus pulposus can be removed, conditioned or treated, and then re-implanted either alone or with a replacement material. In this regard, the temporarily removed nucleus pulposus can serve as a scaffold seeded with cells or treated with a growth factor or any other of the therapeutic agents disclosed herein. The fasteners and sutures of the present invention may be used to approximate the annulus incisions. Any number of fasteners may be used to fully close the incision.
The nucleus pulposus replacement material or prosthesis may also be positioned between the superior and inferior vertebrae through a vertebral body. As mentioned previously, a passage or channel may be made through the vertebral body extending from the outer surface to the adjacent nucleus pulposus. All, some, or none of the existing nucleus pulposus may be removed prior to insertion of the replacement material or prosthesis. In an exemplary embodiment, the replacement material is injected through the incision or channel in the vertebra and into the nucleus pulposus area. This material may be flowable for injection then once injected may become less flowable to form a gel-like material or, alternatively, may become generally solid to form a rubber-like material. Additionally, the nucleus pulposus replacement material may be flowable or injected into a balloon or bladder which may be positioned between adjacent vertebral bodies.
In another embodiment, the replacement material or prosthesis may be rubber-like or gel-like pellets having a configuration which allows them to be passed through the incision or channel. The replacement material or prosthesis may be expandable so that, once inserted, it can fill the implant area. The materials or prosthesis may include an adhesive and/or therapeutic substances, like antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides.
Surgery of the intervertebral disc may leave the spine with increased motion or shear which can cause further disc failure, facet hypertrophy, or arthritis of the facet joints. To stabilize the repaired intervertebral disc “on the way out,” the devices and methods of the present invention may be utilized. Flexible fixation of tissue at and near the operation site may allow compression of tissue and limited motion of the repaired intervertebral disc allowing ligaments, the annulus fibrosis, interspinous ligaments, and other soft tissue to properly heal. Stabilizing one vertebral body to another vertebral body under compression would still allow for some range of motion of the joint yet prevent disc degeneration.
The vertebral bodies may be stabilized anteriorly and/or posteriorly or with a hybrid approach such as an anterior-lateral or posterior-lateral approach. For example, on the anterior side of the spine, two fasteners 30 are positioned to secure the ends of a suture 100 placed through the intervertebral disc 80 and through adjacent vertebrae 82 and 84 in a curved or looped configuration. Two other fasteners 30 are positioned against or within the vertebrae 82 and 84 to hold the ends of a suture or sutures 100 placed through the disc 80 and through the adjacent vertebrae 82 and 84 in a generally straight configuration. Two more fasteners 30 are positioned against or within two vertebrae 102 and 104 located a distance from the repaired disc 80. A suture or sutures 100 are placed between these vertebrae 102 and 104 and tensioned. These fasteners and sutures provide stability and an enhanced healing environment for the intervertebral disc.
Finally,
A damaged intervertebral disc may require replacement instead of just minor repair. The disc may be replaced with a prosthetic disc which may include a biocompatible material such as metal, polymer, composite, ceramic, or combinations thereof.
A disc replacement component may be positioned between the lower surface of a superior vertebra and the upper surface of an inferior vertebra. In this configuration, the disc replacement component takes the place of the original intervertebral disc and provides the proper spacing between the vertebrae. Such a disc component may be anchored to the surfaces of the superior and inferior vertebrae with the fasteners and sutures described herein and incorporated by reference.
Alternatively, and as shown in
The upper and lower sections 112 and 116 of the disc replacement component 110 may include therapeutic substances, like antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides. Finally, the upper and lower sections 112 and 116 may include an expandable material. This material could be compressed then allowed to expand once implanted. Alternatively, the material could be hydrophilic and expand when it comes in contact with liquid. Examples of such expandable materials are desiccated body tissue, foam, and expandable polymers.
The middle section 114 of the disc implant 110 includes a flexible or resilient material. The middle section 114 functions as the original intervertebral disc. Materials which may be used in the middle section 114 include rubber, gel, foam, polymer, collagen, body tissue, or other suitable material. The middle section 114 may also include an expandable material. Furthermore, therapeutic substances such as antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides may be included in the middle section 114 of the disc replacement implant 110.
The disc implant 110 is positioned as follows. The superior vertebra 118 may be cut to receive the upper section 112 of the disc implant 110, while the inferior vertebra 120 may be cut to receive the lower section 116 of the implant 110. The cuts may be made from any side of the vertebral body. However, it is preferred that cutting the vertebrae 118 and 120 results in minimal disruption of the surrounding tendons, muscles, nerves, and ligaments, like the anterior and posterior longitudinal ligaments. The cuts may be planar and generally perpendicular to the longitudinal axis of the spine. The cuts may also be multi-planar such that the pedicles and facet joints are not affected or weakened.
The upper, middle, and lower sections 112, 114, and 116 of the implant 110 combine to form a height which when the implant 110 is positioned between the cut portions of the superior and inferior vertebrae 118 and 120, is generally the same height of the normal intervertebral disc and adjacent vertebral bodies. This technique is analogous to a total knee replacement procedure. The femur, tibia, and patella are cut and prepared for implant components. Once affixed, the knee replacement components return the knee joint to its normal height, configuration, and function. The spinal implant 110 of the present invention is similar; it returns the spinal column to its normal height and function.
To secure the disc implant 110 to the cut superior and inferior vertebrae 82 and 84, the sutures, fasteners, and methods of the present invention may be used. As seen in
The disc implant 110 is further anchored to the superior and inferior vertebrae 82 and 84 with fasteners, sutures, and tubular members. Two fasteners 30 are positioned within or against the vertebrae 82 and 84. Two other fasteners 30 are placed within or against the disc implant. Sutures 100 are positioned within tubular members or sleeves 52 that extend between the fasteners. The tubular members 52 may have a thin cylindrical wall which engages the bone of the vertebrae 82 and 84 and material of the implant 110. By inserting the tubular members 52 in such an orientation, the superior and inferior vertebrae 82 and 84 and disc implant 110 are maintained in alignment.
It is also contemplated that the tubular member or sleeve may be placed within ligaments, tendons, muscles, bones, or combinations thereof. For example, the tubular member may be positioned in bones, including transverse process, pedicles, facets, spinous process, posterior arch, odontoid process, posterior tubercle, lateral articular process, uncinate process, anterior tubercle, carotid tubercle, and vertebral body. The tubular member may also be positioned in ligaments, including the anterior longitudinal ligament, posterior longitudinal ligament, interspinous ligaments, supraspinous ligament, ligamentum flavum, intertransverse ligament, facet capsulary ligament, ligamentum nuchae, and ligaments of the sacrum and coccyx spine.
Following intervertebral disc replacement, the spine and surrounding tissue may be become weakened. To stabilize these regions “on the way out,” the devices and methods of the present invention may be utilized. Flexible fixation of tissue at and near the operation site may allow compression of tissue and limited motion of the prosthetic intervertebral disc allowing ligaments, the annulus fibrosis, interspinous ligaments, and other hard or soft tissue to properly heal. Stabilizing one vertebral body to another vertebral body under compression would allow for some range of motion of the joint and prevent disc degeneration and reduce the incidence of postoperative pain.
The devices and methods of the present invention may be further used to stabilize an implant positioned within the body. In addition to the type of implants previously mentioned, the implant may be an organ, partial organ grafts, tissue graft material (autogenic, allogenic, xenogenic, or synthetic), a malleable implant like a sponge, mesh, bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal, polymer, composite, or ceramic. Other implants include breast implants, biodegradable plates, metallic fasteners, rods, plates, screws, spacers, cages, compliant bearing implants for one or more compartments of the knee, nucleus pulposus implant, stents, meniscal implants, tissue grafts, tissue scaffolds, biodegradable collagen scaffolds, and polymeric or other biocompatible scaffolds.
Also, fasteners and sutures may be utilized to position bone replacement implants including joint replacement components such as for the knee and hip, drug delivery implants, pain pumps, spinal implants, dental implants, tissue implants, tissue patches such as porcine, bovine, or patches disclosed in U.S. Pat. No. 6,592,625 to Cauthen, and other implants. The previously mentioned patent is hereby incorporated by reference. The implants, fasteners, and sutures may also include cells bonded to their surface. The cells may be bonded with a biocompatible adhesive, such as those describe herein, and/or may be bonded electromagnetically or with vanderwalls forces. While implant anchoring is described below in reference to intervertebral disc implants, it should be understood that the methods described herein may be used for anchoring any implant with the body.
In
As previously mentioned, the implant may be any object surgically placed within the body. The implant may be made from various biocompatible materials. Also, the implant may be expandable within the body. A hydrophilic implant may swell or expand by absorbing liquid. A resilient implant may be compressed prior to implantation, then expand once positioned within the body. It is contemplated that an expandable implant may be stabilized using any method and device disclosed herein. In addition, the expandable implant may be held with fasteners and sutures such that expansion of the implant may be directed in a preferred direction or directions. Moreover, electromagnetic pulsed energy may be used to thermally lock a suture to the implant within the body.
In
The present invention also provides an enclosure 140 for stabilizing and anchoring an implant and furthermore to direct expansion of the implant in zero, one, or more desired directions.
The pouch may be made from any natural or artificial material. For example, it may be formed from material which is polymeric, composite, metallic, ceramic, or combinations thereof. Furthermore, the pouch may be made of or include body tissue including bone, collagen, cartilage, muscle, tendon, ligaments, or other tissue graft material. The material of the pouch may be solid, porous, bioabsorbable, bioerodible, degradable, and/or biodegradable. The pouch may be made from a porous matrix or mesh of biocompatible and/or bioabsorbable fibers or filaments acting as a scaffold to regenerate tissue. The fibers or filaments may be interlaced, braided, or knitted to form the pouch.
The pouch may include or may be filled with therapeutic substances or drugs, like antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides. The pouch may further include or be filled with a gelatin which may contain a therapeutic agent. The gelatin inside the pouch may slowly osmotically leak out into the surrounding tissue.
The pouch may also include an adhesive to bond the pouch to the implant, to bond the pouch to the implantation site, and/or bond the flap to the pouch. Such adhesives may include cyanoacrylate adhesives, hydrogel adhesives, monomer and polymer adhesives, fibrin, polysaccharide, Indermil® or any other biocompatible adhesive. A pouch filled with one or more therapeutic agents may form a drug cocktail implant. The therapeutic agents selected to be inserted within the pouch may be specifically tailored to the needs of the patient. The pouch may be filled outside or within the patient. Once placed within the body, the therapeutic agent may slowly dissolve and exit the pouch through an osmotic member to reach the surrounding tissue.
In another exemplary embodiment,
Instability of joints between bones has long been the cause of disability and functional limitation in patients. Joints of the musculoskeletal system have varying degrees of intrinsic stability based on joint geometry and ligament and soft tissue investment. Ligaments are soft tissue condensations in or around the joint that reinforce and hold the joint together while also controlling and restricting various movements of the joints. When a joint becomes unstable, either through disease or traumatic injury, its soft tissue or bony structures allow for excessive motion of the joint surfaces relative to each other and in directions not normally permitted by the ligaments.
Common problems associated with excessive joint motion are malalignment problems, subluxation of the joint, and possibly joint dislocation. Typically, the more motion a joint normally demonstrates, the more inherently loose is the soft tissue surrounding the joint. A loose ligament or group of ligaments ultimately causes skeletal disorders. However, over tensioning ligaments restricts motion of the joint and can also cause musculoskeletal problems.
The present invention also provides methods of tensioning a ligament (or tendon) or group of ligaments (or tendons) during a surgical procedure and “on the way out” after the surgical procedure to prevent joint instability and reduce pain. These methods can be applied to any ligament in the body, including the ligaments of the knee (like the anterior cruciate ligament and iliotibial band), shoulder, elbow, wrist, hip, ankle, hands, and feet. For illustrative purposes, the methods of the present invention are described with reference to the spine.
When an intervertebral disc becomes herniated and loses nucleus pulposus tissue, the distance between the adjacent vertebrae is reduced from the compression of the annulus and remaining nucleus pulposus. As a result, the spine ligaments may become relaxed. These ligaments may include, but are not limited to, the anterior longitudinal ligament, posterior longitudinal ligament, interspinous ligaments, supraspinous ligament, ligamentum flavum, intertransverse ligament, facet capsulary ligament, ligamentum nuchae, and ligaments of the sacrum and coccyx spine.
A fastener 30 is positioned against the ligament 150 adjacent the upper end of a loosened region 152 of the ligament 150. Another fastener 30 is positioned against the ligament 150 adjacent the lower end of the loosened region 152. A suture 100 is positioned through the ligament 150 and through the fasteners 30. The suture 100 is tensioned thereby tightening the loosened region 152 of the ligament 150.
In another embodiment, a fastener 30 is positioned against the ligament 150 above a stretched region 154. Another fastener 30 is placed against the ligament 150 below the stretched region 154. A suture 100 is placed through the ligament 150, adjacent vertebrae 156 and 158, and intervertebral disc 80 in a curved or looped configuration. The suture 100 is tensioned to tighten the stretched region 154.
In a further embodiment represented in
To stabilize the spine while a loosened or torn ligament heals, a stabilization implant, such as a rod or plate 162, may be positioned adjacent spinous processes 164. The fasteners and sutures of the present invention may be used to secure the rod or plate 162 to the spine. A plurality of fasteners 30 is positioned against the rod or plate 162 proximate to each spinous process 164. A second plurality of fasteners 30 is placed within or against the spinous processes 164. Sutures 100 extend between the fasteners 30 and are tensioned. Once anchored, the rod or plate 162 limits movement of the spinous processes 164 relative to each other thereby limiting movement of the anterior longitudinal ligament 150.
It is contemplated that the fasteners of the present invention be placed within or adjacent any bone of the body. When used in the knee, for example, the fasteners may be placed adjacent the femur, tibia, or patella. Within the spine, an fastener may be positioned adjacent a posterior arch, a spinous process, a lateral or medial articular process, a pedicle, odontoid process, uncinate process, a posterior tubercle, carotid tubercle, or a vertebral body.
The present invention may also be used in ligament or tendon reconstruction. Ligaments are frequently damaged, detached, torn, or ruptured as the result of injury or surgery. A damaged ligament can impede proper motion of a joint and cause pain. Therefore, during or “on the way out” from a surgical procedure, a ligament may be reconstructed using a fastener, a tissue graft, and/or a tissue scaffold with or without cells.
The devices and methods of the present invention may be used with a tissue or artificial graft to tension and stabilize the damaged ligament. Any ligament of the body may be repaired using the present invention, including the ligaments of the spine, shoulder, elbow, hip, knee, ankle, feet, and hands. The present invention is described in reference to ligaments of the spine including the anterior and posterior longitudinal ligaments, interspinous ligaments, supraspinous ligaments, superior costotransverse ligaments, ligamentum flavum, facet capsulary ligament, intertransverse ligament, ligamentum nuchae, and ligaments of the sacrum and coccyx spine.
In an exemplary embodiment,
In another embodiment,
To stabilize the longitudinal ligament 150 while the damaged region 172 heals, sutures and fasteners may be placed on the posterior side of the spine for stabilization. One fastener 30 is placed within or against a spinous process 164, while another fastener 30 is positioned within or against a pedicle or bone of the facet joint 176. A suture 100 extends between the fasteners 30 thereby limiting movement of the spine.
The ligament or bone graft may be obtained from a variety of sources and/or made from various materials. In an exemplary embodiment, the ligament graft is made of collagen. The graft could also include autograft, allograft, or xenograft material. The graft may be a tendon graft, bone-tendon-bone graft, or a meniscus graft. Other material which may be used in the formation of the graft is polymer, carbon fiber, PEEK, PTFE, a biodegradable material, elastic or flexible material, Gore-Tex®, or woven fiber. The ligament graft may include therapeutic substances. These include antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immo suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, stem cells, enzymes, proteins, hormones, and germicides.
Use of grafts or patches to repair, reconstruct, and augment tissue, like a ligament, may include patches such as TissueMend® patches, Restore® patches, or similar products.
In addition to ligament repair and reconstruction, the devices and methods of the present invention may be used for ligament or tendon augmentation. Ligament augmentation reinforces or supplements natural ligaments. A ligament may be augmented or reinforced after it has been repaired or reconstructed. Also, a non-repaired ligament may be augmented prophylactically. In this case, the augmentation may be used to increase the load-bearing capacity of the ligament or tendon. Additionally, or alternatively, the augmentation may be used to prevent a potential injury to a ligament or tendon. For example, an athlete may undergo minimally invasive surgery to reinforce a ligament or tendon so as to prevent the ligament or tendon from being injured later in the athlete's career. Many talented athletes' careers are cut short because of any injury to a body joint, like the knee, shoulder, ankle, spine, wrist, or hip. If an athlete desired to prevent or at least reduce the chance of sustaining a career ending injury, he/she could have surgery to augment or “fail-safe” a joint and its ligaments and tendons even if there are no other risk factors other than the occupation. Of course, other risk factors, such as genetic predisposition, could be considered, if desired.
The devices and techniques described herein relate to augmenting any ligament or tendon of the body including ligaments of the knee, shoulder, spine, hand, foot, hip, and elbow. For illustrative purposes only, ligament augmentation is described with reference to the anterior cruciate ligament (ACL) of the knee. It should be understood that the description of augmentation to the knee is not limiting to other ligaments and tendons.
In an exemplary embodiment, fasteners and a suture (or similar device like a cable, band, flexible moment arm, pin, rod, or K-wire) may be used to augment a ligament. Referring to
In a further exemplary embodiment, a tissue graft or scaffold (reinforcement means) 182 may be used to augment the ligament or tendon 180. The graft or scaffold 182 may be configured and include materials as previously described herein. The graft or scaffold 182 may be positioned generally parallel to the ligament 180 requiring augmentation. The ends of the graft 182 may be anchored to bone, ligament, or other tissue using the devices and methods of the present invention. For example, one fastener may be positioned in or against the graft while another fastener may be placed in or against adjacent tissue. A suture may be tensioned between the fasteners, and the ends of the suture secured with the fasteners. Also, a fastener 30 may be positioned against the graft or adjacent tissue, and a suture 100 may be wrapped around the adjacent tissue and graft one or multiple times to form a band or latching. The suture 100 may be tensioned and secured with the fastener 30. It is contemplated that multiple grafts and/or scaffolds may be used to augment the ligament or tendon. For example, grafts or scaffolds may be at different angles to the ligament to provide augmentation in multiple directions.
Furthermore, it is contemplated that the graft or scaffold 182 used to augment the ligament or tendon may be secured to tissue using a band-like device 184. The band 184 may be wrapped around the graft or scaffold 182 and adjacent tissue, like a bone 186. The band 184 may be a biocompatible elastic band, a tissue graft, a polymeric or metallic tie (like a wire tie), or other suitable banding apparatus.
The suture and/or graft (reinforcement means) 182 used to augment the ligament or tendon may be placed parallel or diagonal to the ligament or tendon. Also, the suture and/or graft may be helically or spirally wrapped around the ligament or tendon. The ligament or tendon may be helically or spirally wrapped around the suture or graft. The reinforcement means may be positioned within or interwoven, braided, or weaved into the ligament or tendon.
As previously described, an athlete may desire to undergo elective surgery to “fail safe” a joint and/or ligaments. A football player, for example, who is at high risk for a knee injury may choose to augment or reinforce the anterior cruciate ligament 250, posterior cruciate ligament 252, tibial collateral ligament 254, fibular collateral ligament 256, posterior meniscofemoral ligament 258, and/or transverse ligament 260. The suture, cable, and/or graft used to reinforce the ligament may be tensioned and positioned such that the natural ligament is exclusively used during normal athletic activities. However, when the joint (knee) is extended or dislocated beyond its normal range of motion, the reinforcement means (suture, cable, graft, flexible rod, etc.) engages to stop the extension or dislocation thereby preventing injury to the joint. The engagement of the reinforcement means may provide a sudden stopping action when the joint or ligament is about to reach or has reached an abnormal position. Alternatively or additionally, the engagement of the reinforcement means may provide a gradual stopped action (e.g. stretching/elastic) as the joint/ligament approaches its maximum normal range.
The reinforcement means 182 may be implanted between bones, ligaments, and/or tendons. When the ACL is to be augmented or reinforced, the reinforcement means may extend between the femur 262, tibia 264, and/or fibula 265, may extend from the superior end of the ligament to the tibia and/or fibula, may extend from the inferior end of the ligament to the femur, and/or may extend between the superior and inferior ends of the ligament itself. The reinforcement means may be positioned parallel or at an angle to the ligament. The means may be a tubular sheath 266 that encapsulates the ligament, like a sheath on a wire or a braided sheath 268 on a fuel or hydraulic line. The sheath (reinforcement means) would function as previously described, i.e. provide gradual and/or sudden stopping action to the joint/ligament.
It is contemplated that augmentation or reinforcement of ligaments and tendons of a joint for athletes or other patients be performed using minimally invasive techniques. In the case of an athlete undergoing reinforcement or “fail safe” surgery, the surgeon must produce a minimum amount of dislocation and resection of soft tissue in order to minimize recovery time. Furthermore, physicians could take into consideration the natural growing rate of the athlete/patient. As the athlete grows and/or gains size and weight from physical workouts, the length, strength, and size of joints/ligaments/tendons may change. To account for this, the reinforcement means may be modifiable using a small portal in soft tissue to access the means in the joint. Once accessed, an extension 270 may be added to the reinforcement means. Alternatively, the reinforcement means may include three portions. The two end portions 272 may be fastened in tissue while the middle portion 274 resides between the end portions. The middle portion 274 may be disconnected from the end portions 272 and replaced with a different middle portion 274 having a different length, strength, and/or size. In this configuration, the end portions are not removed from the tissue therefore there is no healing time required for the end portions to secure to tissue.
A laminectomy is a surgical procedure which is designed to relieve pressure on the spinal cord or nerve root that is being caused by a slipped or herniated disk in the lumbar spine. A laminectomy removes a portion of bone over the nerve root or disc material from under the nerve root to give the nerve root more space and a better healing environment. Also, a laminectomy is effective to decrease pain and improve function for a patient with lumbar spinal stenosis. Spinal stenosis is caused by degenerative changes that result in enlargement of the facet joints. The enlarged joints place pressure on the nerves. During a laminectomy, there is much muscle stripping and ligament tearing. The back muscles or erector spinae are dissected off the lamina on both sides and at multiple levels. The facet joints, directly over the nerve roots, are cut to give the nerve roots space. Usually, once the nerve roots are provided with more room, the operation is completed by closing the skin incision. The methods and devices of the present invention may be used to repair, reconstruct, augment, and stabilize tissue or an implant “on the way out” of the pathway created in the soft tissue to access the nerve roots. Muscle may be reattached to muscle; ligaments may be repaired or reconstructed; tissue grafts may be implanted; bones may be stabilized; and implants may be inserted.
Referring to
Another fixation device is placed between the inferior and superior spinous processes. A fastener 30 may be positioned against one of the spinous processes 164, and a suture 100 may be wrapped between two spinous processes 164. The suture 100 may be tensioned, and the ends of the suture 100 may be secured with the fastener 30. This configuration provides further flexible stabilization of the spinal column near the laminectomy site. Finally, a ligament graft or scaffold 182 may be positioned along the ligamentum flavum 190 over the laminectomy site. The graft 182 may reconnect and stabilize the ligamentum flavum 190. It should be understood that additional fasteners may be used to compress and stabilize surrounding tissue.
Following surgery within the body, especially surgery of a joint, the soft tissue around and near the joint may become weakened, and the range of motion of the joint usually increases thereby allowing excessive tissue laxity. Also, instability of a joint may be caused by structural changes within the joint as a result of trauma, degeneration, aging, disease, surgery, or a combinations thereof. An unstable joint may be fused to form a permanent or rigid internal fixation of all or part of the joint. Alternatively, joints may be stabilized with the devices and methods of the present invention, without fusion. In an exemplary embodiment, tissue may be repaired, reconstructed, augmented, and stabilized during and “on the way out” of a surgical procedure such as those surgical procedures described herein. Compressing and stabilizing the tissue around a joint enhances tissue healing. Using flexible fixation, the tissue may be secured but still allow for some range of motion of the joint. Where flexible fixation is not desired, the devices and methods of the present invention may be used for rigid fixation, such as for bones.
As a further example, fasteners and sutures could be used to stabilize the knee joint. The sutures could be positioned between at least two of the femur, tibia, patella, and adjacent ligaments to stabilize the knee without significantly restricting the knee's normal range of motion. Moreover, the devices and methods may be used to stabilize any joint of the body, including the spine, shoulder, elbow, wrist, hip, knee, ankle, and joints of the hands and feet. Additionally, the present invention may be used with a temporal mandibular joint, SI joint, facet joint, temporomandibular joint, and sacroiliac joint.
For illustrative purposes, the present invention is described in greater detail with respect to the spine.
Further stabilization of the cervical spine may be obtained by placing sutures and fasteners lower in the cervical spine. In an exemplary embodiment, a crisscross pattern of sutures is placed between two adjacent vertebrae. The upper fasteners 30 may be placed within or against the superior vertebra 82, while the lower fasteners 30 may be positioned within or against the inferior vertebra 84. Sutures 100 extend between the fasteners, and when tensioned, the sutures 100 stabilize the vertebrae 82 and 84 from movement between one another.
In another embodiment as shown in
In another exemplary embodiment, multiple vertebrae may be decompressed by positioning fasteners 30 on two vertebrae 210 and 218 which are separated by two or more vertebrae. A tubular member or sleeve 52 is positioned between the fasteners 30 and through the vertebrae in between. A suture 100 is placed within the sleeve 52, tensioned, and secured with the fasteners 30. Moreover, the fasteners 30 may be placed on any part/portion of the vertebrae 210 and 218, as described previously, so when the suture is tensioned, one or more vertebrae are decompressed, forming a decompressed region 224.
As further seen in
While
The suture, or similar device like a cable, band, flexible moment arm, pin, rod, or K-wire, is made of a material having sufficient strength and fatigue characteristics. The suture may be biodegradable and/or flexible. It may include metallic material, ceramic material, polymeric material, composite material, or combinations thereof. In one embodiment, the suture is formed of fiber material like carbon or polyamide fibers. Sutures may also be formed from Mersilene®, polypropylene braided or collagen strips, allograft or xenograft strips, braided mesh, a polymer, PTFE, or GoreTex®. The suture may be made of or include an elastic, flexible material which stabilizes the skeletal and ligamentous system but allows some movement of the joints. Also, the suture may be barbed or could be a threaded wiring device.
The disclosed methods for spine stabilization described thus far included positioning fasteners against bone or an implant. However, the present invention also contemplates stabilizing a joint of the body by affixing a suture between ligaments, tendons, bones, cartilage, tissue grafts or combinations thereof. For example, a suture may be positioned between a vertebra and a longitudinal ligament, between a spinous process and the supraspinous ligament, or between a facet and a facet capsulary ligament. Any combination of attachment points is contemplated to stabilize the joint.
Furthermore, any of the methods described herein could utilize a plurality of sutures and more than two fasteners. The use of multiple sutures can vary the tension or resistance between the fasteners securing the suture, thereby providing various levels of stability. The use of multiple fasteners, preferably spaced apart and positioned adjacent the region of the joint to be stabilized, could provide various angles of stabilization.
It is further contemplated that by using multiple sutures and fasteners at different locations of the spine, ligaments and bones of the spine may be selectively tightened or stabilized to provide a customized environment for spine healing. For example, the sutures may be tightened sequentially between the fasteners, or the entire construct could be tightened down together.
Related Techniques
It is contemplated that the devices and methods of the present invention be applied using minimally invasive incisions and techniques to preserve muscles, tendons, ligaments, bones, nerves, and blood vessels. A small incision(s) may be made adjacent the damaged tissue area to be repaired, and a tube, delivery catheter, sheath, cannula, or expandable cannula may be used to perform the methods of the present invention. U.S. Pat. No. 5,320,611 entitled, Expandable Cannula Having Longitudinal Wire and Method of Use, discloses cannulas for surgical and medical use expandable along their entire lengths. The cannulas are inserted through tissue when in an unexpanded condition and with a small diameter. The cannulas are then expanded radially outwardly to give a full-size instrument passage. Expansion of the cannulas occurs against the viscoelastic resistance of the surrounding tissue. The expandable cannulas do not require a full depth incision, or at most require only a needle-size entrance opening.
Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 disclose cannulas for surgical and medical use expandable along their entire lengths. The cannula has a pointed end portion and includes wires having cores which are enclosed by jackets. The jackets are integrally formed as one piece with a sheath of the cannula. The cannula may be expanded by inserting members or by fluid pressure. The cannula is advantageously utilized to expand a vessel, such as a blood vessel. An expandable chamber may be provided at the distal end of the cannula. The above mentioned patents are hereby incorporated by reference.
In addition to using a cannula with the methods of the present invention, an introducer may be utilized to position fasteners at a specific location within the body. U.S. Pat. No. 5,948,002 entitled, Apparatus and Method for Use in Positioning a Suture Anchor, discloses devices for controlling the placement depth of a fastener. Also, U.S. patent application Ser. No. 10/102,413 discloses methods of securing body tissue with a robotic mechanism. The above-mentioned patent and application are hereby incorporated by reference. Another introducer or cannula which may be used with the present invention is the VersaStep® System by Tyco® Healthcare.
The present invention may also be utilized with minimally invasive surgery techniques disclosed in U.S. patent application Ser. No. 10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patent documents disclose, inter alia, apparatus and methods for minimally invasive joint replacement. The femoral, tibial, and/or patellar components of a knee replacement may be fastened or locked to each other and to adjacent tissue using fasteners disclosed herein and incorporated by reference. Furthermore, the methods and devices of the present invention may be utilized for repairing, reconstructing, augmenting, and securing tissue or implants during and “on the way out” of a knee replacement procedure. For example, the anterior cruciate ligament and other ligaments may be repaired or reconstructed; quadriceps mechanisms and other muscles may be repaired. The patent documents mentioned above are hereby incorporated by reference.
Moreover, the devices and methods of the present invention may by used to approximate a skin incision where there may be undue tension on the skin. Fasteners may be placed on opposite sides of the incision, and a suture or cable may be placed between the fasteners. When the suture is tensioned, the skin may be pulled together and held until the skin tissue relaxes. Then, the fasteners may be unlocked, and the suture may be tensioned again to further approximate the skin incision. The locking and unlocking of the fasteners along with the tensioning of the suture may be repeated until the incision is fully closed.
Furthermore, it is contemplated that the present invention may be used with bariatric surgery, colorectal surgery, plastic surgery, gastroesophageal reflex disease (GERD) surgery, or for repairing hernias. A band, mesh, or cage of synthetic material or body tissue may be placed around an intestine or other tubular body member. The band may seal the intestine. This method may be performed over a balloon or bladder so that anastomosis is maintained. The inner diameter of the tubular body part is maintained by the balloon. The outer diameter of the body part is then closed or wrapped with a band, mesh, or patch. The inner diameter of the tubular body member may be narrowed or restricted by the band. The band may be secured to the tubular body part or surrounding tissue with the devices and methods described herein and incorporated by reference.
In addition, intramedullary fracture fixation and comminuted fracture fixation may be achieved with the devices and methods of the present invention. For example, a plate or rod may be positioned within or against the fractured bone. A fastener may be driven across the bone and locked onto the plate, rod, or another fastener.
It is further contemplated that the present invention may be used in conjunction with the devices and methods disclosed in U.S. Pat. No. 5,329,846 entitled, Tissue Press and System, and U.S. Pat. No. 5,269,785 entitled, Apparatus and Method for Tissue Removal. For example, an implant secured within the body using the present invention may include tissue harvested, configured, and implanted as described in the patents. The above-mentioned patents are hereby incorporated by reference.
Additionally, it is contemplated that the devices and methods of the present invention may be used with heat bondable materials as disclosed in U.S. Pat. No. 5,593,425 entitled, Surgical Devices Assembled Using Heat Bondable Materials. For example, the fasteners of the present invention may include heat bondable material. The material may be deformed to secure tissue or hold a suture or cable. The fasteners made of heat bondable material may be mechanically crimped, plastically crimped, or may be welded to a suture or cable with RF (Bovie devices), laser, ultrasound, electromagnet, ultraviolet, infrared, electro-shockwave, or other known energy. The welding may be performed in an aqueous, dry, or moist environment. The welding device may be disposable, sterilizable, single-use, and/or battery-operated. The above-mentioned patent is hereby incorporated by reference.
Furthermore, it is contemplated that the methods of the present invention may be performed under indirect visualization, such as endoscopic guidance, computer assisted navigation, magnetic resonance imaging, CT scan, ultrasound, fluoroscopy, X-ray, or other suitable visualization technique. The implants, fasteners, fastener assemblies, and sutures of the present invention may include a radiopaque material for enhancing indirect visualization. The use of these visualization means along with minimally invasive surgery techniques permits physicians to accurately and rapidly repair, reconstruct, augment, and secure tissue or an implant within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423 disclose apparatus and methods for use in medical imaging. Also, the present invention may be performed using robotics, such as haptic arms or similar apparatus. The above-mentioned patents are hereby incorporated by reference.
Moreover, the fasteners and methods of the present invention may be used for the repair and reconstruction of a tubular pathway like a blood vessel, intestine, urinary tract, esophagus, or other similar body parts. For example, a blood vessel may be intentionally severed during a surgical operation, or the blood vessel may be damaged or torn as a result of an injury. Flexible fixation of the vessel would permit the vessel to function properly and also compress and stabilize the vessel for enhanced healing. To facilitate the repair or reconstruction of a body lumen, a balloon may be inserted into the lumen and expanded so the damaged, severed, or torn portion of the vessel is positioned against the outer surface of the inflated balloon. In this configuration, the fasteners and methods described and incorporated herein may be used to approximate the damaged portion of the vessel.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention.
This application is a continuation of U.S. application Ser. No. 17/933,274, filed Sep. 19, 2022, which is a continuation of U.S. application Ser. No. 16/011,185, filed Jun. 18, 2018, issued as U.S. Pat. No. 11,457,958; which is a continuation of U.S. application Ser. No. 14/205,442, filed Mar. 12, 2014, issued as U.S. Pat. No. 9,999,449; which is a continuation of U.S. patent application Ser. No. 11/258,795, filed Oct. 26, 2005, which claims the benefit of U.S. Provisional Patent Application No. 60/622,095, filed Oct. 26, 2004, the entirety of which is incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 319296 | Moleworth | Jun 1885 | A |
| 668878 | Jensen | Feb 1901 | A |
| 668879 | Miller | Feb 1901 | A |
| 702789 | Gibson | Jun 1902 | A |
| 862712 | Collins et al. | Aug 1907 | A |
| 2121193 | Hanicke | Dec 1932 | A |
| 2199025 | Conn | Jun 1936 | A |
| 2187852 | Friddle | Aug 1936 | A |
| 2178840 | Lorenian | Nov 1936 | A |
| 2235419 | Callahan et al. | Mar 1938 | A |
| 2248054 | Becker | Jun 1939 | A |
| 2270188 | LongFellow | Jul 1940 | A |
| 2518276 | Brawand | Aug 1950 | A |
| 2557669 | Lloyd | Jun 1951 | A |
| 2566499 | Richter | Sep 1951 | A |
| 2621653 | Briggs | Dec 1952 | A |
| 2725053 | Bambara et al. | Nov 1955 | A |
| 2830587 | Evertt | Apr 1958 | A |
| 3204635 | Voss et al. | Sep 1965 | A |
| 3238396 | Schubring et al. | Mar 1966 | A |
| 3347234 | Voss et al. | Oct 1967 | A |
| 3367809 | Soloff | Feb 1968 | A |
| 3391690 | Armao | Jul 1968 | A |
| 3477429 | Sampson | Nov 1969 | A |
| 3513848 | Winston et al. | May 1970 | A |
| 3518993 | Blake | Jul 1970 | A |
| 3577991 | Walkinson | May 1971 | A |
| 3596292 | Robert | Aug 1971 | A |
| 3608539 | Miller | Sep 1971 | A |
| 3625220 | Engelsher | Dec 1971 | A |
| 3648705 | Lary | Mar 1972 | A |
| 3653388 | Tenckhoff | Apr 1972 | A |
| 3656476 | Swinney | Apr 1972 | A |
| 3657056 | Winston et al. | Apr 1972 | A |
| 3678980 | Gutshall | Jul 1972 | A |
| 3709218 | Halloran | Jan 1973 | A |
| 3711347 | Wagner et al. | Jan 1973 | A |
| 3760808 | Bleuer | Sep 1973 | A |
| 3788318 | Kim et al. | Jan 1974 | A |
| 3789852 | Kim et al. | Feb 1974 | A |
| 3802438 | Wolvek | Apr 1974 | A |
| 3807394 | Attenborough | Apr 1974 | A |
| 3809075 | Matles | May 1974 | A |
| 3811449 | Gravlee et al. | May 1974 | A |
| 3825010 | McDonald | Jul 1974 | A |
| 3833003 | Taricco | Sep 1974 | A |
| 3835849 | McGuire | Sep 1974 | A |
| 3842824 | Neufeld | Oct 1974 | A |
| 3857396 | Hardwick | Dec 1974 | A |
| 3867932 | Huene | Feb 1975 | A |
| 3875652 | Arnold et al. | Apr 1975 | A |
| 3898992 | Balamuth | Aug 1975 | A |
| 3918442 | Nikolaev et al. | Nov 1975 | A |
| 3968800 | Vilasi | Jul 1976 | A |
| 4023559 | Gaskell | May 1977 | A |
| 4064566 | Fletcher et al. | Dec 1977 | A |
| 4089071 | Kalnberz et al. | May 1978 | A |
| 4156574 | Boden | May 1979 | A |
| 4164794 | Spector et al. | Aug 1979 | A |
| 4171544 | Hench et al. | Oct 1979 | A |
| 4183102 | Guiset | Jan 1980 | A |
| 4199864 | Ashman | Apr 1980 | A |
| 4200939 | Oser | May 1980 | A |
| 4210148 | Stivala | Jul 1980 | A |
| 4213816 | Morris | Jul 1980 | A |
| 4226228 | Shin et al. | Oct 1980 | A |
| 4235233 | Mouwen | Nov 1980 | A |
| 4235238 | Ogiu et al. | Nov 1980 | A |
| 4257411 | Cho | Mar 1981 | A |
| 4265231 | Scheller, Jr. et al. | May 1981 | A |
| 4281649 | Derweduwen | Aug 1981 | A |
| 4291698 | Fuchs et al. | Sep 1981 | A |
| 4309488 | Heide et al. | Jan 1982 | A |
| 4320762 | Bentov | Mar 1982 | A |
| 4351069 | Ballintyn et al. | Sep 1982 | A |
| 4364381 | Sher et al. | Dec 1982 | A |
| 4365356 | Broemer et al. | Dec 1982 | A |
| 4388921 | Sutter et al. | Jun 1983 | A |
| 4395798 | McVey | Aug 1983 | A |
| 4409974 | Freedland | Oct 1983 | A |
| 4414166 | Charlson et al. | Nov 1983 | A |
| 4437191 | van der Zel et al. | Mar 1984 | A |
| 4437362 | Hurst | Mar 1984 | A |
| 4444180 | Schneider et al. | Apr 1984 | A |
| 4448194 | DiGiovanni et al. | May 1984 | A |
| 4456005 | Lichty | Jun 1984 | A |
| 4461281 | Carson | Jul 1984 | A |
| 4493317 | Klaue | Jan 1985 | A |
| 4495664 | Blanquaert | Jan 1985 | A |
| 4501031 | McDaniel et al. | Feb 1985 | A |
| 4504268 | Herlitze | Mar 1985 | A |
| 4506681 | Mundell | Mar 1985 | A |
| 4514125 | Stol | Apr 1985 | A |
| 4526173 | Sheehan | Jul 1985 | A |
| 4532926 | O'Holla | Aug 1985 | A |
| 4535772 | Sheehan | Aug 1985 | A |
| 4547327 | Bruins et al. | Oct 1985 | A |
| 4556350 | Bernhardt et al. | Dec 1985 | A |
| 4566138 | Lewis et al. | Jan 1986 | A |
| 4589868 | Dretler | May 1986 | A |
| 4590928 | Hunt | May 1986 | A |
| 4597379 | Kihn et al. | Jul 1986 | A |
| 4599085 | Riess et al. | Jul 1986 | A |
| 4601893 | Cardinal | Jul 1986 | A |
| 4606335 | Wedeen | Aug 1986 | A |
| 4621640 | Mulhollan et al. | Nov 1986 | A |
| 4630609 | Chin | Dec 1986 | A |
| 4632100 | Somer et al. | Dec 1986 | A |
| 4632101 | Freedland | Dec 1986 | A |
| 4645503 | Lin et al. | Feb 1987 | A |
| 4657460 | Bien | Apr 1987 | A |
| 4659268 | Del Mundo et al. | Apr 1987 | A |
| 4662063 | Collins et al. | May 1987 | A |
| 4662068 | Polonsky | May 1987 | A |
| 4662887 | Turner et al. | May 1987 | A |
| 4669473 | Richards et al. | Jun 1987 | A |
| 4685458 | Leckrone | Aug 1987 | A |
| 4691741 | Affa et al. | Sep 1987 | A |
| 4705040 | Mueller et al. | Nov 1987 | A |
| 4706670 | Andersen et al. | Nov 1987 | A |
| 4708139 | Dunbar, IV | Nov 1987 | A |
| 4713077 | Small | Dec 1987 | A |
| 4716901 | Jackson et al. | Jan 1988 | A |
| 4718909 | Brown | Jan 1988 | A |
| 4722331 | Fox | Feb 1988 | A |
| 4722948 | Sanderson | Feb 1988 | A |
| 4724584 | Kasai | Feb 1988 | A |
| 4738255 | Goble et al. | Apr 1988 | A |
| 4739751 | Sapega et al. | Apr 1988 | A |
| 4741330 | Hayhurst | May 1988 | A |
| 4743257 | Tormala et al. | May 1988 | A |
| 4749585 | Greco et al. | Jun 1988 | A |
| 4750492 | Jacobs | Jun 1988 | A |
| 4768507 | Fischell et al. | Sep 1988 | A |
| 4772286 | Goble et al. | Sep 1988 | A |
| 4776328 | Frey et al. | Oct 1988 | A |
| 4776738 | Winston | Oct 1988 | A |
| 4776851 | Bruchman et al. | Oct 1988 | A |
| 4781182 | Purnell et al. | Nov 1988 | A |
| 4790303 | Steffee | Dec 1988 | A |
| 4792336 | Hlavacek et al. | Dec 1988 | A |
| 4817591 | Klaue | Apr 1989 | A |
| 4822224 | Carl et al. | Apr 1989 | A |
| 4823794 | Pierce | Apr 1989 | A |
| 4832025 | Coates | May 1989 | A |
| 4832026 | Jones | May 1989 | A |
| 4834752 | Van Kampen | May 1989 | A |
| 4841960 | Garner | Jun 1989 | A |
| 4843112 | Gerhart et al. | Jun 1989 | A |
| 4846812 | Walker et al. | Jul 1989 | A |
| 4862882 | Venturi et al. | Sep 1989 | A |
| 4869242 | Galluzzo | Sep 1989 | A |
| 4870957 | Goble et al. | Oct 1989 | A |
| 4883048 | Purnell et al. | Nov 1989 | A |
| 4890612 | Kensey | Jan 1990 | A |
| 4895148 | Bays et al. | Jan 1990 | A |
| 4898156 | Gatturna et al. | Feb 1990 | A |
| 4899729 | Gill et al. | Feb 1990 | A |
| 4899744 | Fujitsuka et al. | Feb 1990 | A |
| 4901721 | Hakki | Feb 1990 | A |
| 4921479 | Grayzel | May 1990 | A |
| 4922897 | Sapega et al. | May 1990 | A |
| 4924866 | Yoon | May 1990 | A |
| 4932960 | Green et al. | Jun 1990 | A |
| 4935026 | McFadden | Jun 1990 | A |
| 4935028 | Drews | Jun 1990 | A |
| 4945625 | Winston | Aug 1990 | A |
| 4946468 | Li | Aug 1990 | A |
| 4950285 | Wilk | Aug 1990 | A |
| 4954126 | Wallsten | Sep 1990 | A |
| 4955910 | Bolesky | Sep 1990 | A |
| 4957498 | Caspari et al. | Sep 1990 | A |
| 4961741 | Hayhurst | Oct 1990 | A |
| 4963151 | Ducheyne et al. | Oct 1990 | A |
| 4966583 | Debbas | Oct 1990 | A |
| 4968315 | Gatturna | Nov 1990 | A |
| 4968317 | Tormala et al. | Nov 1990 | A |
| 4969888 | Scholten et al. | Nov 1990 | A |
| 4969892 | Burton et al. | Nov 1990 | A |
| 4990161 | Kampner | Feb 1991 | A |
| 4994071 | MacGregor | Feb 1991 | A |
| 4997445 | Hodorek | Mar 1991 | A |
| 4998539 | Delsanti | Mar 1991 | A |
| 5002550 | Li | Mar 1991 | A |
| 5002563 | Pyka et al. | Mar 1991 | A |
| 5009652 | Morgan et al. | Apr 1991 | A |
| 5009663 | Broome | Apr 1991 | A |
| 5009664 | Sievers | Apr 1991 | A |
| 5013316 | Goble et al. | May 1991 | A |
| 5019090 | Pinchuk | May 1991 | A |
| 5021059 | Kensey et al. | Jun 1991 | A |
| 5035713 | Friis | Jul 1991 | A |
| 5037404 | Gold et al. | Aug 1991 | A |
| 5037422 | Hayhurst et al. | Aug 1991 | A |
| 5041093 | Chu | Aug 1991 | A |
| 5041114 | Chapman et al. | Aug 1991 | A |
| 5041129 | Hayhurst et al. | Aug 1991 | A |
| 5046513 | Gatturna et al. | Sep 1991 | A |
| 5047055 | Bao et al. | Sep 1991 | A |
| 5051049 | Wills | Sep 1991 | A |
| 5053046 | Janese | Oct 1991 | A |
| 5053047 | Yoon | Oct 1991 | A |
| 5059193 | Kuslich | Oct 1991 | A |
| 5059206 | Winters | Oct 1991 | A |
| 5061274 | Kensey | Oct 1991 | A |
| 5061286 | Lyle | Oct 1991 | A |
| 5064286 | Ai et al. | Nov 1991 | A |
| 5069674 | Fearnot et al. | Dec 1991 | A |
| 5078731 | Hayhurst | Jan 1992 | A |
| 5078744 | Chvapil | Jan 1992 | A |
| 5078745 | Rhenter et al. | Jan 1992 | A |
| 5084050 | Draenert | Jan 1992 | A |
| 5084051 | Tormala et al. | Jan 1992 | A |
| 5085660 | Lin | Feb 1992 | A |
| 5085661 | Moss | Feb 1992 | A |
| 5098433 | Freedland | Mar 1992 | A |
| 5098434 | Serbousek | Mar 1992 | A |
| 5098436 | Ferrante et al. | Mar 1992 | A |
| 5100405 | McLaren | Mar 1992 | A |
| 5100417 | Cerier et al. | Mar 1992 | A |
| 5102417 | Palmaz | Apr 1992 | A |
| 5102421 | Anspach, Jr. | Apr 1992 | A |
| 5108399 | Eitenmuller et al. | Apr 1992 | A |
| 5120175 | Arbegast et al. | Jun 1992 | A |
| 5123520 | Schmid et al. | Jun 1992 | A |
| 5123914 | Cope | Jun 1992 | A |
| 5123941 | Lauren et al. | Jun 1992 | A |
| 5133732 | Wiktor | Jul 1992 | A |
| RE34021 | Mueller et al. | Aug 1992 | E |
| 5141520 | Goble et al. | Aug 1992 | A |
| 5147362 | Goble | Sep 1992 | A |
| 5152790 | Rosenberg et al. | Oct 1992 | A |
| 5154720 | Trott et al. | Oct 1992 | A |
| 5156613 | Sawyer | Oct 1992 | A |
| 5156616 | Meadows et al. | Oct 1992 | A |
| 5158566 | Pianetti | Oct 1992 | A |
| 5158934 | Ammann et al. | Oct 1992 | A |
| 5163960 | Bonutti | Nov 1992 | A |
| 5171251 | Bregen et al. | Dec 1992 | A |
| 5176682 | Chow | Jan 1993 | A |
| 5179964 | Cook | Jan 1993 | A |
| 5180385 | Sontag | Jan 1993 | A |
| 5180388 | DiCarlo | Jan 1993 | A |
| 5183464 | Dubrul et al. | Feb 1993 | A |
| 5192287 | Fournier et al. | Mar 1993 | A |
| 5192326 | Bao et al. | Mar 1993 | A |
| 5197166 | Meier et al. | Mar 1993 | A |
| 5197971 | Bonutti | Mar 1993 | A |
| 5203784 | Ross et al. | Apr 1993 | A |
| 5203787 | Noblitt et al. | Apr 1993 | A |
| 5208950 | Merritt | May 1993 | A |
| 5209776 | Bass et al. | May 1993 | A |
| 5217493 | Raad et al. | Jun 1993 | A |
| 5219359 | McQuilkin et al. | Jun 1993 | A |
| 5226899 | Lee et al. | Jul 1993 | A |
| 5234006 | Eaton et al. | Aug 1993 | A |
| 5234425 | Fogarty et al. | Aug 1993 | A |
| 5234443 | Phan et al. | Aug 1993 | A |
| 5236438 | Wilk | Aug 1993 | A |
| 5236445 | Hayhurst et al. | Aug 1993 | A |
| 5242902 | Murphy et al. | Sep 1993 | A |
| 5254113 | Wilk | Oct 1993 | A |
| 5258007 | Spetzler et al. | Nov 1993 | A |
| 5258015 | Li et al. | Nov 1993 | A |
| 5258016 | DiPoto et al. | Nov 1993 | A |
| 5261886 | Chesterfield et al. | Nov 1993 | A |
| 5266325 | Kuzma et al. | Nov 1993 | A |
| 5269783 | Sander | Dec 1993 | A |
| 5269785 | Bonutti | Dec 1993 | A |
| 5269809 | Hayhurst et al. | Dec 1993 | A |
| 5281235 | Haber et al. | Jan 1994 | A |
| 5282832 | Toso et al. | Feb 1994 | A |
| 5290281 | Tschakaloff | Mar 1994 | A |
| 5304119 | Balaban et al. | Apr 1994 | A |
| 5306280 | Bregen et al. | Apr 1994 | A |
| 5306301 | Graf et al. | Apr 1994 | A |
| 5312410 | Miller | May 1994 | A |
| 5315741 | Dubberke | May 1994 | A |
| 5318588 | Horzewski et al. | Jun 1994 | A |
| 5320611 | Bonutti et al. | Jun 1994 | A |
| 5324308 | Pierce | Jun 1994 | A |
| 5328480 | Melker et al. | Jul 1994 | A |
| 5329846 | Bonutti | Jul 1994 | A |
| 5329924 | Bonutti | Jul 1994 | A |
| 5330468 | Burkhart | Jul 1994 | A |
| 5330476 | Hiot et al. | Jul 1994 | A |
| 5330486 | Wilk | Jul 1994 | A |
| 5336231 | Adair | Aug 1994 | A |
| 5336240 | Metzler et al. | Aug 1994 | A |
| 5339799 | Kami et al. | Aug 1994 | A |
| 5349956 | Bonutti | Sep 1994 | A |
| 5352229 | Goble et al. | Oct 1994 | A |
| 5354298 | Lee et al. | Oct 1994 | A |
| 5354302 | Ko | Oct 1994 | A |
| 5366480 | Corriveau et al. | Nov 1994 | A |
| 5370646 | Reese et al. | Dec 1994 | A |
| 5370660 | Weinstein et al. | Dec 1994 | A |
| 5372146 | Branch | Dec 1994 | A |
| 5374235 | Ahrens | Dec 1994 | A |
| 5376126 | Lin | Dec 1994 | A |
| 5382254 | McGarry et al. | Jan 1995 | A |
| 5383883 | Wilk et al. | Jan 1995 | A |
| 5383905 | Golds et al. | Jan 1995 | A |
| 5391173 | Wilk | Feb 1995 | A |
| 5395308 | Fox et al. | Mar 1995 | A |
| 5397311 | Walker et al. | Mar 1995 | A |
| 5400805 | Warren | Mar 1995 | A |
| 5403312 | Yates et al. | Apr 1995 | A |
| 5403348 | Bonutti | Apr 1995 | A |
| 5405359 | Pierce | Apr 1995 | A |
| 5411523 | Goble | May 1995 | A |
| 5413585 | Pagedas | May 1995 | A |
| 5417691 | Hayhurst | May 1995 | A |
| 5417701 | Holmes | May 1995 | A |
| 5417712 | Whittaker et al. | May 1995 | A |
| 5423796 | Shikhman et al. | Jun 1995 | A |
| 5431670 | Holmes | Jul 1995 | A |
| 5439470 | Li | Aug 1995 | A |
| 5441538 | Bonutti | Aug 1995 | A |
| 5443512 | Parr et al. | Aug 1995 | A |
| 5447503 | Miller | Sep 1995 | A |
| 5449361 | Pereissman | Sep 1995 | A |
| 5449372 | Schmaltz et al. | Sep 1995 | A |
| 5449382 | Dayton | Sep 1995 | A |
| 5451235 | Lock et al. | Sep 1995 | A |
| 5453090 | Martinez et al. | Sep 1995 | A |
| 5456722 | McLeod et al. | Oct 1995 | A |
| 5458653 | Davidson | Oct 1995 | A |
| 5462561 | Voda | Oct 1995 | A |
| 5464424 | O'Donnell, Jr. | Nov 1995 | A |
| 5464426 | Bonutti | Nov 1995 | A |
| 5464427 | Curtis et al. | Nov 1995 | A |
| 5470337 | Moss | Nov 1995 | A |
| 5472444 | Huebner et al. | Dec 1995 | A |
| 5474554 | Ku | Dec 1995 | A |
| 5478351 | Meade et al. | Dec 1995 | A |
| 5478353 | Yoon | Dec 1995 | A |
| 5480403 | Lee et al. | Jan 1996 | A |
| 5486197 | Le et al. | Jan 1996 | A |
| 5487844 | Fujita | Jan 1996 | A |
| 5488958 | Topel et al. | Feb 1996 | A |
| 5496292 | Burnham | Mar 1996 | A |
| 5496318 | Howland et al. | Mar 1996 | A |
| 5496335 | Thomason et al. | Mar 1996 | A |
| 5496348 | Bonutti | Mar 1996 | A |
| 5500000 | Feagin et al. | Mar 1996 | A |
| 5501700 | Hirata | Mar 1996 | A |
| 5504977 | Weppner et al. | Apr 1996 | A |
| 5505735 | Li | Apr 1996 | A |
| 5507754 | Green et al. | Apr 1996 | A |
| 5522844 | Johnson | Jun 1996 | A |
| 5522845 | Wenstrom, Jr. | Jun 1996 | A |
| 5522846 | Bonutti | Jun 1996 | A |
| 5527341 | Gogolewski et al. | Jun 1996 | A |
| 5527342 | Pietrzak et al. | Jun 1996 | A |
| 5527343 | Bonutti | Jun 1996 | A |
| 5529075 | Clark | Jun 1996 | A |
| 5531759 | Kensey et al. | Jul 1996 | A |
| 5534012 | Bonutti | Jul 1996 | A |
| 5534028 | Bao et al. | Jul 1996 | A |
| 5540698 | Pereissman | Jul 1996 | A |
| 5540718 | Bartlett | Jul 1996 | A |
| 5542423 | Bonutti | Aug 1996 | A |
| 5545178 | Kensey et al. | Aug 1996 | A |
| 5545180 | Le et al. | Aug 1996 | A |
| 5545206 | Carson | Aug 1996 | A |
| 5545630 | Maienfisch et al. | Aug 1996 | A |
| 5549630 | Bonutti | Aug 1996 | A |
| 5549631 | Bonutti | Aug 1996 | A |
| 5556402 | Xu | Sep 1996 | A |
| 5569252 | Justin et al. | Oct 1996 | A |
| 5569253 | Farris et al. | Oct 1996 | A |
| 5569305 | Bonutti | Oct 1996 | A |
| 5569306 | Thal | Oct 1996 | A |
| 5573517 | Bonutti et al. | Nov 1996 | A |
| 5573538 | Laboureau | Nov 1996 | A |
| 5573542 | Stevens | Nov 1996 | A |
| 5575801 | Habermeyer et al. | Nov 1996 | A |
| 5575819 | Amis | Nov 1996 | A |
| 5578046 | Liu et al. | Nov 1996 | A |
| 5580344 | Hasson | Dec 1996 | A |
| 5584835 | Greenfield | Dec 1996 | A |
| 5584839 | Gieringer | Dec 1996 | A |
| 5584860 | Goble et al. | Dec 1996 | A |
| 5584862 | Bonutti | Dec 1996 | A |
| 5591206 | Moufarrege | Jan 1997 | A |
| 5593422 | Muijs Van de Moer et al. | Jan 1997 | A |
| 5593425 | Bonutti et al. | Jan 1997 | A |
| 5593625 | Riebel et al. | Jan 1997 | A |
| 5601557 | Hayhurst | Feb 1997 | A |
| 5601558 | Torrie et al. | Feb 1997 | A |
| 5601595 | Smith | Feb 1997 | A |
| 5607427 | Tschakaloff | Mar 1997 | A |
| 5609595 | Pennig | Mar 1997 | A |
| 5618314 | Harwin et al. | Apr 1997 | A |
| 5620461 | Muijs Van De Moer et al. | Apr 1997 | A |
| 5626612 | Bartlett | May 1997 | A |
| 5626614 | Hart | May 1997 | A |
| 5626718 | Philippe et al. | May 1997 | A |
| 5628751 | Sander et al. | May 1997 | A |
| 5630824 | Hart | May 1997 | A |
| 5634926 | Jobe | Jun 1997 | A |
| 5643274 | Sander et al. | Jul 1997 | A |
| 5643293 | Kogasaka et al. | Jul 1997 | A |
| 5643295 | Yoon | Jul 1997 | A |
| 5643321 | McDevitt | Jul 1997 | A |
| 5645553 | Kolesa et al. | Jul 1997 | A |
| 5645597 | Krapiva | Jul 1997 | A |
| 5645599 | Samani | Jul 1997 | A |
| 5649955 | Hashimoto et al. | Jul 1997 | A |
| 5649963 | McDevitt | Jul 1997 | A |
| 5651377 | O'Donnell, Jr. | Jul 1997 | A |
| 5658313 | Thal | Aug 1997 | A |
| 5660225 | Saffran | Aug 1997 | A |
| 5662658 | Wenstrom, Jr. | Sep 1997 | A |
| 5665089 | Dall et al. | Sep 1997 | A |
| 5665109 | Yoon | Sep 1997 | A |
| 5667513 | Torrie et al. | Sep 1997 | A |
| 5669917 | Sauer et al. | Sep 1997 | A |
| 5674240 | Bonutti et al. | Oct 1997 | A |
| 5681310 | Yuan et al. | Oct 1997 | A |
| 5681333 | Burkhart et al. | Oct 1997 | A |
| 5681351 | Jamiolkowski et al. | Oct 1997 | A |
| 5681352 | Clancy, III et al. | Oct 1997 | A |
| 5685820 | Riek et al. | Nov 1997 | A |
| 5688283 | Knapp | Nov 1997 | A |
| 5690654 | Ovil | Nov 1997 | A |
| 5690655 | Hart et al. | Nov 1997 | A |
| 5690676 | DiPoto et al. | Nov 1997 | A |
| 5693055 | Zahiri et al. | Dec 1997 | A |
| 5697950 | Fucci et al. | Dec 1997 | A |
| 5702397 | Goble et al. | Dec 1997 | A |
| 5702422 | Stone | Dec 1997 | A |
| 5702462 | Oberlander | Dec 1997 | A |
| 5704936 | Mazel | Jan 1998 | A |
| 5707395 | Li | Jan 1998 | A |
| 5713903 | Sander et al. | Feb 1998 | A |
| 5713921 | Bonutti | Feb 1998 | A |
| 5718717 | Bonutti | Feb 1998 | A |
| 5720747 | Burke | Feb 1998 | A |
| 5720753 | Sander et al. | Feb 1998 | A |
| 5725541 | Anspach, III et al. | Mar 1998 | A |
| 5725556 | Moser et al. | Mar 1998 | A |
| 5725582 | Bevan | Mar 1998 | A |
| 5730747 | Ek et al. | Mar 1998 | A |
| 5733306 | Bonutti | Mar 1998 | A |
| 5735875 | Bonutti et al. | Apr 1998 | A |
| 5735877 | Pagedas | Apr 1998 | A |
| 5735899 | Schwartz et al. | Apr 1998 | A |
| 5741282 | Anspach, III et al. | Apr 1998 | A |
| 5752952 | Adamson | May 1998 | A |
| 5752974 | Rhee et al. | May 1998 | A |
| 5755809 | Cohen et al. | May 1998 | A |
| 5762458 | Wang et al. | Jun 1998 | A |
| 5766221 | Benderev et al. | Jun 1998 | A |
| 5769894 | Ferragamo | Jun 1998 | A |
| 5772672 | Toy et al. | Jun 1998 | A |
| 5776151 | Chan | Jul 1998 | A |
| 5779706 | Tschakaloff | Jul 1998 | A |
| 5782831 | Sherman et al. | Jul 1998 | A |
| 5782862 | Bonutti | Jul 1998 | A |
| 5785713 | Jobe | Jul 1998 | A |
| 5792096 | Rentmeester et al. | Aug 1998 | A |
| 5797931 | Bito et al. | Aug 1998 | A |
| 5800537 | Bell | Sep 1998 | A |
| 5807403 | Beyar et al. | Sep 1998 | A |
| 5810849 | Kontos | Sep 1998 | A |
| 5810853 | Yoon | Sep 1998 | A |
| 5810884 | Kim | Sep 1998 | A |
| 5811721 | Andersson et al. | Sep 1998 | A |
| 5814072 | Bonutti | Sep 1998 | A |
| 5814073 | Bonutti | Sep 1998 | A |
| 5817107 | Schaller | Oct 1998 | A |
| 5823994 | Sharkey et al. | Oct 1998 | A |
| 5824009 | Fukuda et al. | Oct 1998 | A |
| 5830125 | Scribner et al. | Nov 1998 | A |
| 5836897 | Sakurai et al. | Nov 1998 | A |
| 5839899 | Robinson | Nov 1998 | A |
| 5843084 | Hart et al. | Dec 1998 | A |
| 5843178 | Vanney et al. | Dec 1998 | A |
| 5845645 | Bonutti | Dec 1998 | A |
| 5851185 | Berns | Dec 1998 | A |
| 5865834 | McGuire | Feb 1999 | A |
| 5866634 | Tokushige et al. | Feb 1999 | A |
| 5868749 | Reed | Feb 1999 | A |
| 5874235 | Chan et al. | Feb 1999 | A |
| 5879372 | Bartlett | Mar 1999 | A |
| 5891166 | Schervinsky | Apr 1999 | A |
| 5891168 | Thal | Apr 1999 | A |
| 5893880 | Egan et al. | Apr 1999 | A |
| 5897574 | Bonutti | Apr 1999 | A |
| 5899911 | Carter | May 1999 | A |
| 5899921 | Caspari et al. | May 1999 | A |
| 5906579 | Vander Salm et al. | May 1999 | A |
| 5906625 | Bito et al. | May 1999 | A |
| 5908429 | Yoon | Jun 1999 | A |
| 5911721 | Nicholson et al. | Jun 1999 | A |
| 5918604 | Whelan | Jul 1999 | A |
| 5919193 | Slavitt | Jul 1999 | A |
| 5919194 | Anderson | Jul 1999 | A |
| 5919208 | Valenti | Jul 1999 | A |
| 5919215 | Wiklund et al. | Jul 1999 | A |
| 5921986 | Bonutti | Jul 1999 | A |
| 5925064 | Meyers et al. | Jul 1999 | A |
| 5928244 | Tovey et al. | Jul 1999 | A |
| 5928267 | Bonutti et al. | Jul 1999 | A |
| 5931838 | Vito | Aug 1999 | A |
| 5931869 | Boucher et al. | Aug 1999 | A |
| 5940942 | Fong | Aug 1999 | A |
| 5941900 | Bonutti | Aug 1999 | A |
| 5941901 | Egan | Aug 1999 | A |
| 5944750 | Tanner et al. | Aug 1999 | A |
| 5945002 | Leukes et al. | Aug 1999 | A |
| 5947982 | Duran | Sep 1999 | A |
| 5948000 | Larsen et al. | Sep 1999 | A |
| 5948001 | Larsen | Sep 1999 | A |
| 5948002 | Bonutti | Sep 1999 | A |
| 5951590 | Goldfarb | Sep 1999 | A |
| 5957953 | DiPoto et al. | Sep 1999 | A |
| 5961499 | Bonutti et al. | Oct 1999 | A |
| 5961521 | Roger | Oct 1999 | A |
| 5961554 | Janson et al. | Oct 1999 | A |
| 5964765 | Fenton, Jr. et al. | Oct 1999 | A |
| 5964769 | Wagner et al. | Oct 1999 | A |
| 5968046 | Castleman | Oct 1999 | A |
| 5968047 | Reed | Oct 1999 | A |
| 5980520 | Vancaillie | Nov 1999 | A |
| 5980559 | Bonutti | Nov 1999 | A |
| 5984929 | Bashiri et al. | Nov 1999 | A |
| 5989282 | Bonutti | Nov 1999 | A |
| 5993458 | Vaitekunas et al. | Nov 1999 | A |
| 5993477 | Vaitekunas et al. | Nov 1999 | A |
| 6007567 | Bonutti | Dec 1999 | A |
| 6007580 | Lehto et al. | Dec 1999 | A |
| 6010525 | Bonutti et al. | Jan 2000 | A |
| 6010526 | Sandstrom et al. | Jan 2000 | A |
| 6017321 | Boone | Jan 2000 | A |
| 6033429 | Magovern | Mar 2000 | A |
| 6033430 | Bonutti | Mar 2000 | A |
| 6045551 | Bonutti | Apr 2000 | A |
| 6050998 | Fletcher | Apr 2000 | A |
| 6056751 | Fenton, Jr. | May 2000 | A |
| 6056772 | Bonutti | May 2000 | A |
| 6056773 | Bonutti | May 2000 | A |
| 6059797 | Mears | May 2000 | A |
| 6059817 | Bonutti et al. | May 2000 | A |
| 6059827 | Fenton, Jr. | May 2000 | A |
| 6063095 | Wang et al. | May 2000 | A |
| 6066151 | Miyawaki et al. | May 2000 | A |
| 6066160 | Colvin et al. | May 2000 | A |
| 6066166 | Bischoff et al. | May 2000 | A |
| 6068637 | Popov et al. | May 2000 | A |
| 6068648 | Cole et al. | May 2000 | A |
| 6077277 | Mollenauer et al. | Jun 2000 | A |
| 6077292 | Bonutti | Jun 2000 | A |
| 6080161 | Eaves, III et al. | Jun 2000 | A |
| 6080192 | Demopulos et al. | Jun 2000 | A |
| 6083243 | Pokropinski et al. | Jul 2000 | A |
| 6083522 | Chu et al. | Jul 2000 | A |
| 6086593 | Bonutti | Jul 2000 | A |
| 6086608 | Ek et al. | Jul 2000 | A |
| 6090072 | Kratoska et al. | Jul 2000 | A |
| 6099531 | Bonutti | Aug 2000 | A |
| 6099537 | Sugai et al. | Aug 2000 | A |
| 6099550 | Yoon | Aug 2000 | A |
| 6099552 | Adams | Aug 2000 | A |
| 6102850 | Wang et al. | Aug 2000 | A |
| 6106545 | Egan | Aug 2000 | A |
| 6117160 | Bonutti | Sep 2000 | A |
| 6120536 | Ding et al. | Sep 2000 | A |
| 6125574 | Ganaja et al. | Oct 2000 | A |
| 6126677 | Ganaja et al. | Oct 2000 | A |
| 6139320 | Hahn | Oct 2000 | A |
| RE36974 | Bonutti | Nov 2000 | E |
| 6149669 | Li | Nov 2000 | A |
| 6152949 | Bonutti | Nov 2000 | A |
| 6155756 | Mericle et al. | Dec 2000 | A |
| 6159224 | Yoon | Dec 2000 | A |
| 6159234 | Bonutti et al. | Dec 2000 | A |
| 6171299 | Bonutti | Jan 2001 | B1 |
| 6171307 | Orlich | Jan 2001 | B1 |
| 6174324 | Egan et al. | Jan 2001 | B1 |
| 6179840 | Bowman | Jan 2001 | B1 |
| 6179850 | Goradia | Jan 2001 | B1 |
| 6187008 | Hamman | Feb 2001 | B1 |
| 6190400 | Van De Moer et al. | Feb 2001 | B1 |
| 6190401 | Green et al. | Feb 2001 | B1 |
| 6200322 | Branch et al. | Mar 2001 | B1 |
| 6217591 | Egan et al. | Apr 2001 | B1 |
| 6224593 | Ryan et al. | May 2001 | B1 |
| 6224630 | Bao et al. | May 2001 | B1 |
| 6228086 | Wahl et al. | May 2001 | B1 |
| 6231592 | Bonutti et al. | May 2001 | B1 |
| 6238395 | Bonutti | May 2001 | B1 |
| 6238396 | Lombardo | May 2001 | B1 |
| 6248106 | Ferree | Jun 2001 | B1 |
| 6258091 | Sevrain et al. | Jul 2001 | B1 |
| 6264675 | Brotz | Jul 2001 | B1 |
| 6267761 | Ryan | Jul 2001 | B1 |
| 6273717 | Hahn et al. | Aug 2001 | B1 |
| 6280474 | Cassidy et al. | Aug 2001 | B1 |
| 6286746 | Egan et al. | Sep 2001 | B1 |
| 6287325 | Bonutti | Sep 2001 | B1 |
| 6293961 | Schwartz et al. | Sep 2001 | B2 |
| 6306159 | Schwartz et al. | Oct 2001 | B1 |
| 6309405 | Bonutti | Oct 2001 | B1 |
| 6312448 | Bonutti | Nov 2001 | B1 |
| 6338730 | Bonutti et al. | Jan 2002 | B1 |
| 6340365 | Dittrich et al. | Jan 2002 | B2 |
| 6348056 | Bates et al. | Feb 2002 | B1 |
| 6358271 | Egan et al. | Mar 2002 | B1 |
| 6364897 | Bonutti | Apr 2002 | B1 |
| 6368325 | McKinley et al. | Apr 2002 | B1 |
| 6368343 | Bonutti et al. | Apr 2002 | B1 |
| 6371957 | Amrein et al. | Apr 2002 | B1 |
| 6409742 | Fulton, III et al. | Jun 2002 | B1 |
| 6409743 | Fenton, Jr. | Jun 2002 | B1 |
| 6419704 | Ferree | Jul 2002 | B1 |
| 6423088 | Fenton, Jr. | Jul 2002 | B1 |
| 6425919 | Lambrecht | Jul 2002 | B1 |
| 6428562 | Bonutti | Aug 2002 | B2 |
| 6432115 | Mollenauer et al. | Aug 2002 | B1 |
| 6447516 | Bonutti | Sep 2002 | B1 |
| 6450985 | Schoelling et al. | Sep 2002 | B1 |
| 6461360 | Adam | Oct 2002 | B1 |
| 6468293 | Bonutti et al. | Oct 2002 | B2 |
| 6475230 | Bonutti et al. | Nov 2002 | B1 |
| 6488196 | Fenton, Jr. | Dec 2002 | B1 |
| 6500195 | Bonutti | Dec 2002 | B2 |
| 6503259 | Huxel et al. | Jan 2003 | B2 |
| 6527774 | Lieberman | Mar 2003 | B2 |
| 6530933 | Yeung et al. | Mar 2003 | B1 |
| 6535764 | Imran et al. | Mar 2003 | B2 |
| 6544267 | Cole et al. | Apr 2003 | B1 |
| 6545390 | Hahn et al. | Apr 2003 | B1 |
| 6547792 | Tsuji et al. | Apr 2003 | B1 |
| 6551304 | Whalen et al. | Apr 2003 | B1 |
| 6551343 | Tormala et al. | Apr 2003 | B1 |
| 6554852 | Oberlander | Apr 2003 | B1 |
| 6557426 | Reinemann, Jr. et al. | May 2003 | B2 |
| 6558390 | Cragg | May 2003 | B2 |
| 6568313 | Fukui et al. | May 2003 | B2 |
| 6569187 | Bonutti et al. | May 2003 | B1 |
| 6572635 | Bonutti | Jun 2003 | B1 |
| D477776 | Pontaoe | Jul 2003 | S |
| 6585750 | Bonutti et al. | Jul 2003 | B2 |
| 6585764 | Wright et al. | Jul 2003 | B2 |
| 6592609 | Bonutti | Jul 2003 | B1 |
| 6594517 | Nevo | Jul 2003 | B1 |
| 6602293 | Biermann et al. | Aug 2003 | B1 |
| 6605090 | Trieu et al. | Aug 2003 | B1 |
| 6610080 | Morgan | Aug 2003 | B2 |
| 6618910 | Pontaoe | Sep 2003 | B1 |
| 6620195 | Goble et al. | Sep 2003 | B2 |
| 6623486 | Weaver et al. | Sep 2003 | B1 |
| 6623487 | Goshert | Sep 2003 | B1 |
| 6623488 | Leone, Jr. | Sep 2003 | B1 |
| 6626944 | Taylor | Sep 2003 | B1 |
| 6632245 | Kim | Oct 2003 | B2 |
| 6635073 | Bonutti | Oct 2003 | B2 |
| 6638279 | Bonutti | Oct 2003 | B2 |
| 6641592 | Sauer et al. | Nov 2003 | B1 |
| 6645227 | Fallin et al. | Nov 2003 | B2 |
| 6652585 | Lange | Nov 2003 | B2 |
| 6666877 | Morgan et al. | Dec 2003 | B2 |
| 6669705 | Westhaver et al. | Dec 2003 | B2 |
| 6679888 | Green et al. | Jan 2004 | B2 |
| 6679917 | Ek | Jan 2004 | B2 |
| 6685750 | Plos et al. | Feb 2004 | B1 |
| 6699240 | Francischelli | Mar 2004 | B2 |
| 6702821 | Bonutti | Mar 2004 | B2 |
| 6705179 | Mohtasham | Mar 2004 | B1 |
| 6709457 | Otte et al. | Mar 2004 | B1 |
| 6719765 | Bonutti | Apr 2004 | B2 |
| 6719795 | Cornwall et al. | Apr 2004 | B1 |
| 6719797 | Ferree | Apr 2004 | B1 |
| 6722552 | Fenton, Jr. | Apr 2004 | B2 |
| 6733531 | Trieu | May 2004 | B1 |
| 6764513 | Dowling | Jul 2004 | B1 |
| 6764514 | Li et al. | Jul 2004 | B1 |
| 6770078 | Bonutti | Aug 2004 | B2 |
| 6780198 | Gregoire et al. | Aug 2004 | B1 |
| 6786989 | Torriani et al. | Sep 2004 | B2 |
| 6796003 | Marvel | Sep 2004 | B1 |
| 6811567 | Reiley | Nov 2004 | B2 |
| 6818010 | Eichhorn et al. | Nov 2004 | B2 |
| 6823871 | Schmieding | Nov 2004 | B2 |
| 6830589 | Erickson | Dec 2004 | B2 |
| 6860885 | Bonutti | Mar 2005 | B2 |
| 6869398 | Obenchain et al. | Mar 2005 | B2 |
| 6878167 | Ferree | Apr 2005 | B2 |
| 6890334 | Brace et al. | May 2005 | B2 |
| 6893434 | Fenton et al. | May 2005 | B2 |
| 6899722 | Bonutti | May 2005 | B2 |
| 6913666 | Aeschlimann et al. | Jul 2005 | B1 |
| 6916321 | TenHuisen et al. | Jul 2005 | B2 |
| 6921264 | Mayer et al. | Jul 2005 | B2 |
| 6923824 | Morgan et al. | Aug 2005 | B2 |
| 6932835 | Bonutti et al. | Aug 2005 | B2 |
| 6942684 | Bonutti | Sep 2005 | B2 |
| 6944111 | Nakamura et al. | Sep 2005 | B2 |
| 6955540 | Mayer et al. | Oct 2005 | B2 |
| 6955683 | Bonutti | Oct 2005 | B2 |
| 6958077 | Suddaby | Oct 2005 | B2 |
| 6981983 | Rosenblatt et al. | Jan 2006 | B1 |
| 6997940 | Bonutti | Feb 2006 | B2 |
| 7001411 | Dean | Feb 2006 | B1 |
| 7004959 | Bonutti | Feb 2006 | B2 |
| 7008226 | Mayer et al. | Mar 2006 | B2 |
| 7018380 | Cole | Mar 2006 | B2 |
| 7033379 | Peterson | Apr 2006 | B2 |
| 7048755 | Bonutti et al. | May 2006 | B2 |
| 7066960 | Dickman | Jun 2006 | B1 |
| 7087073 | Bonutti | Aug 2006 | B2 |
| 7090111 | Egan et al. | Aug 2006 | B2 |
| 7094251 | Bonutti et al. | Aug 2006 | B2 |
| 7104996 | Bonutti | Sep 2006 | B2 |
| 7128763 | Blatt | Oct 2006 | B1 |
| 7147652 | Bonutti et al. | Dec 2006 | B2 |
| 7160405 | Aeschlimann et al. | Jan 2007 | B2 |
| 7179259 | Gibbs | Feb 2007 | B1 |
| 7192448 | Ferree | Mar 2007 | B2 |
| 7217279 | Reese | May 2007 | B2 |
| 7217290 | Bonutti | May 2007 | B2 |
| 7241297 | Shaolian et al. | Jul 2007 | B2 |
| 7250051 | Francischelli | Jul 2007 | B2 |
| 7252685 | Bindseil et al. | Aug 2007 | B2 |
| 7273497 | Ferree | Sep 2007 | B2 |
| 7326200 | Trieu et al. | Feb 2008 | B2 |
| 7329263 | Bonutti et al. | Feb 2008 | B2 |
| 7335205 | Aeschlimann et al. | Feb 2008 | B2 |
| 7377930 | Loughran | May 2008 | B2 |
| 7429266 | Bonutti et al. | Sep 2008 | B2 |
| 7445634 | Trieu | Nov 2008 | B2 |
| 7481825 | Bonutti | Jan 2009 | B2 |
| 7481831 | Bonutti | Jan 2009 | B2 |
| 7510895 | Raterman | Mar 2009 | B2 |
| 7585311 | Green et al. | Sep 2009 | B2 |
| 7597705 | Forsberg et al. | Oct 2009 | B2 |
| 7854750 | Bonutti et al. | Dec 2010 | B2 |
| 7879072 | Bonutti et al. | Feb 2011 | B2 |
| 7891691 | Bearey | Feb 2011 | B2 |
| 7967820 | Bonutti et al. | Jun 2011 | B2 |
| 8041114 | Rother et al. | Oct 2011 | B2 |
| 8128669 | Bonutti | Mar 2012 | B2 |
| 8140982 | Hamilton, II et al. | Mar 2012 | B2 |
| 8147514 | Bonutti | Apr 2012 | B2 |
| 8162977 | Bonutti et al. | Apr 2012 | B2 |
| 8487844 | Koyama | Jul 2013 | B2 |
| 8672969 | Stone et al. | Mar 2014 | B2 |
| 8771314 | Crombie et al. | Jul 2014 | B2 |
| 8845699 | Bonutti | Sep 2014 | B2 |
| 10603029 | Kaiser et al. | Mar 2020 | B2 |
| 20010002440 | Bonutti | May 2001 | A1 |
| 20010008971 | Schwartz et al. | Jul 2001 | A1 |
| 20010009250 | Herman et al. | Jul 2001 | A1 |
| 20010027319 | Ferree | Oct 2001 | A1 |
| 20010041916 | Bonutti | Nov 2001 | A1 |
| 20010056287 | Bonutti | Dec 2001 | A1 |
| 20020013514 | Brau | Jan 2002 | A1 |
| 20020016593 | Hearn et al. | Feb 2002 | A1 |
| 20020016633 | Lin et al. | Feb 2002 | A1 |
| 20020019649 | Sikora et al. | Feb 2002 | A1 |
| 20020026244 | Trieu | Feb 2002 | A1 |
| 20020029067 | Bonutti | Mar 2002 | A1 |
| 20020029083 | Zucherman et al. | Mar 2002 | A1 |
| 20020029084 | Paul et al. | Mar 2002 | A1 |
| 20020045902 | Bonutti | Apr 2002 | A1 |
| 20020055739 | Lieberman | May 2002 | A1 |
| 20020055740 | Lieberman | May 2002 | A1 |
| 20020058966 | Tormala et al. | May 2002 | A1 |
| 20020062153 | Paul et al. | May 2002 | A1 |
| 20020087189 | Bonutti | Jul 2002 | A1 |
| 20020091391 | Cole et al. | Jul 2002 | A1 |
| 20020103495 | Cole | Aug 2002 | A1 |
| 20020107524 | Magana | Aug 2002 | A1 |
| 20020120269 | Lange | Aug 2002 | A1 |
| 20020120270 | Trieu | Aug 2002 | A1 |
| 20020120281 | Overaker | Aug 2002 | A1 |
| 20020123750 | Eisermann et al. | Sep 2002 | A1 |
| 20020143329 | Serhan et al. | Oct 2002 | A1 |
| 20020161439 | Strobel et al. | Oct 2002 | A1 |
| 20020183762 | Anderson et al. | Dec 2002 | A1 |
| 20020188301 | Dallara et al. | Dec 2002 | A1 |
| 20030039196 | Nakamura et al. | Feb 2003 | A1 |
| 20030040758 | Wang et al. | Feb 2003 | A1 |
| 20030065361 | Dreyfuss | Apr 2003 | A1 |
| 20030065391 | Re et al. | Apr 2003 | A1 |
| 20030073998 | Pagiluca et al. | Apr 2003 | A1 |
| 20030083667 | Ralph et al. | May 2003 | A1 |
| 20030097148 | Valimaa et al. | May 2003 | A1 |
| 20030105474 | Bonutti | Jun 2003 | A1 |
| 20030118518 | Hahn et al. | Jun 2003 | A1 |
| 20030125749 | Yuan et al. | Jul 2003 | A1 |
| 20030130735 | Rogalski | Jul 2003 | A1 |
| 20030158555 | Sanders et al. | Aug 2003 | A1 |
| 20030158582 | Bonutti et al. | Aug 2003 | A1 |
| 20030167072 | Oberlander | Sep 2003 | A1 |
| 20030181800 | Bonutti | Sep 2003 | A1 |
| 20030181889 | Little | Sep 2003 | A1 |
| 20030187445 | Keith et al. | Oct 2003 | A1 |
| 20030195514 | Trieu et al. | Oct 2003 | A1 |
| 20030195530 | Thill | Oct 2003 | A1 |
| 20030195565 | Bonutti | Oct 2003 | A1 |
| 20030204204 | Bonutti | Oct 2003 | A1 |
| 20030208203 | Lim et al. | Nov 2003 | A1 |
| 20030216742 | Wetzler et al. | Nov 2003 | A1 |
| 20030225438 | Bonutti et al. | Dec 2003 | A1 |
| 20030229361 | Jackson | Dec 2003 | A1 |
| 20040010287 | Bonutti | Jan 2004 | A1 |
| 20040024457 | Boyce et al. | Feb 2004 | A1 |
| 20040024459 | Ferree | Feb 2004 | A1 |
| 20040030341 | Aeschlimann et al. | Feb 2004 | A1 |
| 20040034357 | Beane et al. | Feb 2004 | A1 |
| 20040039392 | Trieu | Feb 2004 | A1 |
| 20040049207 | Goldfarb et al. | Mar 2004 | A1 |
| 20040059333 | Carl et al. | Mar 2004 | A1 |
| 20040097939 | Bonutti | May 2004 | A1 |
| 20040098050 | Foerster et al. | May 2004 | A1 |
| 20040102788 | Huebner et al. | May 2004 | A1 |
| 20040116963 | Lattouf | Jun 2004 | A1 |
| 20040127907 | Dakin et al. | Jul 2004 | A1 |
| 20040127989 | Dooris et al. | Jul 2004 | A1 |
| 20040133077 | Obenchain et al. | Jul 2004 | A1 |
| 20040138703 | Alleyne | Jul 2004 | A1 |
| 20040138705 | Heino et al. | Jul 2004 | A1 |
| 20040143268 | Falahee | Jul 2004 | A1 |
| 20040143334 | Ferree | Jul 2004 | A1 |
| 20040167548 | Bonutti | Aug 2004 | A1 |
| 20040172063 | Li et al. | Sep 2004 | A1 |
| 20040181225 | Songer | Sep 2004 | A1 |
| 20040186471 | Trieu | Sep 2004 | A1 |
| 20040215199 | Zinkel | Oct 2004 | A1 |
| 20040220616 | Bonutti et al. | Nov 2004 | A1 |
| 20040224459 | Nishikawa | Nov 2004 | A1 |
| 20040225325 | Bonutti | Nov 2004 | A1 |
| 20040230223 | Bonutti et al. | Nov 2004 | A1 |
| 20040236374 | Bonutti et al. | Nov 2004 | A1 |
| 20040260287 | Ferree | Dec 2004 | A1 |
| 20050033362 | Grafton | Feb 2005 | A1 |
| 20050033366 | Cole et al. | Feb 2005 | A1 |
| 20050033434 | Berry | Feb 2005 | A1 |
| 20050038438 | Anderson et al. | Feb 2005 | A1 |
| 20050038514 | Helm et al. | Feb 2005 | A1 |
| 20050043733 | Eisermann et al. | Feb 2005 | A1 |
| 20050043742 | Bruneau et al. | Feb 2005 | A1 |
| 20050043796 | Grant et al. | Feb 2005 | A1 |
| 20050055096 | Serhan et al. | Mar 2005 | A1 |
| 20050065409 | de la Torre et al. | Mar 2005 | A1 |
| 20050070765 | Abdelgany et al. | Mar 2005 | A1 |
| 20050071012 | Serhan et al. | Mar 2005 | A1 |
| 20050075644 | DiPoto et al. | Apr 2005 | A1 |
| 20050090827 | Gedebou | Apr 2005 | A1 |
| 20050096699 | Wixey et al. | May 2005 | A1 |
| 20050113928 | Cragg et al. | May 2005 | A1 |
| 20050125072 | Kolb | Jun 2005 | A1 |
| 20050126680 | Aeschlimann et al. | Jun 2005 | A1 |
| 20050143745 | Hodorek et al. | Jun 2005 | A1 |
| 20050143826 | Zucherman et al. | Jun 2005 | A1 |
| 20050149024 | Ferrante et al. | Jul 2005 | A1 |
| 20050149029 | Bonutti | Jul 2005 | A1 |
| 20050192581 | Molz | Sep 2005 | A1 |
| 20050197537 | Bonadio et al. | Sep 2005 | A1 |
| 20050203521 | Bonutti | Sep 2005 | A1 |
| 20050216059 | Bonutti et al. | Sep 2005 | A1 |
| 20050216087 | Zucherman et al. | Sep 2005 | A1 |
| 20050222620 | Bonutti | Oct 2005 | A1 |
| 20050234459 | Falahee et al. | Oct 2005 | A1 |
| 20050234460 | Miller | Oct 2005 | A1 |
| 20050240190 | Gall et al. | Oct 2005 | A1 |
| 20050240227 | Bonutti | Oct 2005 | A1 |
| 20050246021 | Ringeisen et al. | Nov 2005 | A1 |
| 20050255140 | Hagan et al. | Nov 2005 | A1 |
| 20050256582 | Ferree | Nov 2005 | A1 |
| 20050261684 | Shaolian et al. | Nov 2005 | A1 |
| 20050267481 | Carl et al. | Dec 2005 | A1 |
| 20050267534 | Bonutti et al. | Dec 2005 | A1 |
| 20050283246 | Cauthen, III et al. | Dec 2005 | A1 |
| 20060009846 | Trieu et al. | Jan 2006 | A1 |
| 20060009855 | Goble et al. | Jan 2006 | A1 |
| 20060015101 | Warburton et al. | Jan 2006 | A1 |
| 20060015108 | Bonutti | Jan 2006 | A1 |
| 20060024357 | Carpenter et al. | Feb 2006 | A1 |
| 20060026244 | Watson | Feb 2006 | A1 |
| 20060064095 | Senn et al. | Mar 2006 | A1 |
| 20060089646 | Bonutti | Apr 2006 | A1 |
| 20060122600 | Cole | Jun 2006 | A1 |
| 20060122704 | Vresilovic et al. | Jun 2006 | A1 |
| 20060142799 | Bonutti | Jun 2006 | A1 |
| 20060167495 | Bonutti et al. | Jul 2006 | A1 |
| 20060189982 | Lange | Aug 2006 | A1 |
| 20060200199 | Bonutti et al. | Sep 2006 | A1 |
| 20060212073 | Bonutti et al. | Sep 2006 | A1 |
| 20060217765 | Bonutti et al. | Sep 2006 | A1 |
| 20060229623 | Bonutti et al. | Oct 2006 | A1 |
| 20060235413 | Denham et al. | Oct 2006 | A1 |
| 20060235470 | Bonutti et al. | Oct 2006 | A1 |
| 20060241695 | Bonutti et al. | Oct 2006 | A1 |
| 20060253132 | Evans et al. | Nov 2006 | A1 |
| 20060264953 | Falahee | Nov 2006 | A1 |
| 20060265009 | Bonutti | Nov 2006 | A1 |
| 20060265011 | Bonutti | Nov 2006 | A1 |
| 20070032825 | Bonutti et al. | Feb 2007 | A1 |
| 20070073293 | Martz | Mar 2007 | A1 |
| 20070088362 | Bonutti et al. | Apr 2007 | A1 |
| 20070118129 | Fraser et al. | May 2007 | A1 |
| 20070179503 | Ferree | Aug 2007 | A1 |
| 20070191957 | Anderson et al. | Aug 2007 | A1 |
| 20070198555 | Friedman et al. | Aug 2007 | A1 |
| 20070233092 | Falahee | Oct 2007 | A1 |
| 20070265561 | Yeung | Nov 2007 | A1 |
| 20070270833 | Bonutti et al. | Nov 2007 | A1 |
| 20080021474 | Bonutti et al. | Jan 2008 | A1 |
| 20080039845 | Bonutti et al. | Feb 2008 | A1 |
| 20080039873 | Bonutti et al. | Feb 2008 | A1 |
| 20080046090 | Paul et al. | Feb 2008 | A1 |
| 20080097448 | Binder et al. | Apr 2008 | A1 |
| 20080108897 | Bonutti et al. | May 2008 | A1 |
| 20080108916 | Bonutti et al. | May 2008 | A1 |
| 20080114399 | Bonutti | May 2008 | A1 |
| 20080132950 | Lange | Jun 2008 | A1 |
| 20080140116 | Bonutti | Jun 2008 | A1 |
| 20080140117 | Bonutti et al. | Jun 2008 | A1 |
| 20080195145 | Bonutti et al. | Aug 2008 | A1 |
| 20080269753 | Cannestra | Oct 2008 | A1 |
| 20080269808 | Gall et al. | Oct 2008 | A1 |
| 20080275453 | Lafosse et al. | Nov 2008 | A1 |
| 20090024161 | Bonutti et al. | Jan 2009 | A1 |
| 20090093684 | Schorer | Apr 2009 | A1 |
| 20090138014 | Bonutti | May 2009 | A1 |
| 20090194969 | Bearey | Aug 2009 | A1 |
| 20100211120 | Bonutti et al. | Aug 2010 | A1 |
| 20110060375 | Bonutti | Mar 2011 | A1 |
| 20110295253 | Bonutti et al. | Dec 2011 | A1 |
| 20120165841 | Bonutti | Jun 2012 | A1 |
| 20120191140 | Bonutti | Jul 2012 | A1 |
| 20120215233 | Bonutti et al. | Aug 2012 | A1 |
| 20130030735 | Jau et al. | Jan 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 2641580 | Aug 2007 | CA |
| 2680827 | Sep 2008 | CA |
| 2698057 | Mar 2009 | CA |
| 1903016 | Oct 1964 | DE |
| 1903316 | Oct 1964 | DE |
| 3517204 | Nov 1986 | DE |
| 3722538 | Jan 1989 | DE |
| 9002844 | Dec 1990 | DE |
| 773004 | May 1997 | EP |
| 784454 | Jul 1997 | EP |
| 1614525 | Jan 2006 | EP |
| 1988837 | Nov 2008 | EP |
| 2134294 | Dec 2009 | EP |
| 2696338 | Apr 1994 | FR |
| 2717368 | Sep 1995 | FR |
| 2728779 | Jul 1996 | FR |
| 2736257 | Jan 1997 | FR |
| 2750031 | Dec 1997 | FR |
| 2771621 | Jun 1999 | FR |
| 2785171 | May 2000 | FR |
| 2093701 | Sep 1982 | GB |
| 2306110 | Apr 1997 | GB |
| H08-140982 | Jun 1996 | JP |
| 184396 | Oct 1964 | SU |
| 9112779 | Sep 1991 | WO |
| 9323094 | Nov 1993 | WO |
| 9408642 | Apr 1994 | WO |
| 9516398 | Jun 1995 | WO |
| 9531941 | Nov 1995 | WO |
| 9614802 | May 1996 | WO |
| 9712779 | Apr 1997 | WO |
| 9749347 | Dec 1997 | WO |
| 9811838 | Mar 1998 | WO |
| 9826720 | Jun 1998 | WO |
| 2002053011 | Jul 2002 | WO |
| 2007092869 | Aug 2007 | WO |
| 2008116203 | Sep 2008 | WO |
| 2009029908 | Mar 2009 | WO |
| 2009124215 | Oct 2009 | WO |
| 2010099222 | Sep 2010 | WO |
| Entry |
|---|
| Judgment Final Written Decision for IPR2022-00786 U.S. Pat. No. 9,579,129 B2, Oct. 13, 2023, 51 pages. |
| Judgment Final Written Decision for IPR2022-00787 U.S. Pat. No. 9,999,449 B2, Oct. 13, 2023, 59 pages. |
| The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125 Stat. 284 (2011), amended 35 U.S.C. § 103, effective Mar. 16, 201. |
| Ian K. Y. Lo et al., Abrasion resistance of two types of nonabsorbable braided suture, 20 Arthroscopy 407 (2004). |
| Marshall et al., The Anterior Cruciate Ligament: A Technique of Repair and Reconstruction, 143 Clinical Orthopedics and Related Res. 97 (1997). |
| Daniel M. Wust et al., Mechanical and handling properties of braided polyblend polyethylene sutures in comparison to braided polyester and monofilament polydioxanone sutures, 22 Arthroscopy 1146 (2006). |
| Petition for Inter Parties Review of U.S. Pat. No. 9,999,449, filed Apr. 11, 2022, 81 pages. |
| Arthrex, Protect your graft, Am J Sports Med, vol. 22, No. 4, Jul.-Aug. 1994. |
| Barrett et al, T-Fix endoscopic meniscal repair: technique and approach to different types of tears, Apr. 1995, Arthroscopy vol. 11 No 2 p. 245-51. |
| Cope, Suture Anchor for Visceral Drainage, AJR, vol. 148 p. 160-162, Jan. 1986. |
| Gabriel, Arthroscopic Fixation Devices, Wiley Enc. of Biomed Eng., 2006. |
| Innovasive, We've got you covered, Am J Sports Med, vol. 26, No. 1, Jan.-Feb. 1998. |
| 510k—TranSet Fracture Fixation System, Feb. 24, 2004, k033717. |
| 510k—Linvatec Biomaterials modification of Duet and impact Suture Anchor, Nov. 19, 2004, k042966. |
| 510k, arthrex pushlock, Jun. 29, 2005, K051219. |
| 510k, mitek micro anchor, Nov. 6, 1996, K962511. |
| 510k, Multitak Suture System, Jan. 10, 1997, K964324. |
| 510k, Modified Milek 3.5mm Absorbable Suture Anchor System, Jun. 9, 1997, K970896. |
| 510K, Summary for Arthrex Inc.'s Bio-Interference Screw, Jul. 9, 1997, K971358. |
| 510k, Surgicraft Bone Tie, Sep. 25, 1998, K982719. |
| Karlsson et al, Repair of Bankart lesions with a suture anchor in recurrent dislocation of the shoulder, Scand. J. of Med & Science in Sports, 1995, 5:170-174. |
| Madjar et al, Minimally Invasive Pervaginam Procedures, for the Treatment of Female Stress Incontinence . . . , Artificial Organs, 22 (10) 879-885, 1998. |
| Nowak et al, Comparative Study of Fixation Techniques in the Open Bankart Operation Using Either a Cannulated Screw or Suture-Anchors, Acta Orthopcedica Belgica, vol. 64—2—1998. |
| Packer et al, Repair of Acute Scapho-Lunate Dissociation Facilitated By the “Tag”* Suture Anchor, Journal of Hand Surgery (British and European vol. 1994, 19B: 5: 563-564. |
| Richmond, Modificatio of the Bankart reconstruction with a suture anchor, Am J Sports Med, vol. 19, No. 4, p. 343-346, 1991. |
| Shea et al, Technical Note: Arthroscopic Rotator Cuff Repair Using a Transhumeral Approach to Fixation, Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 14, No. 1 Jan.-Feb. 1998: pp. 118-122. |
| Tfix, Acufexjust tied the knot . . . , Am. J. Sports Med., vol. 22, No. 3, May-Jun. 1994. |
| Wong et al, Case Report: Proper Insertion Angle Is Essential to Prevent Intra-Articular Protrusion of a Knolless Suture Anchor in Shoulder Rotator Cuff Repair, Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 26, No. 2 Feb. 2010: pp. 286-290. |
| Cobb et al., Late Correction of Malunited Intercondylar Humeral Fractures Intra-Articular Osteotomy and Tricortical Bone Grafting, J BoneJointSurg [Br] 1994; 76-B:622-6. |
| Fellinger. et al, Radial avulsion of the triangular fibrocartilage complex in acute wrist trauma: a new technique for arthroscopic repair, Jun. 1997, Arthroscopy vol. 13 No. 3 p. 370-4. |
| Hecker et al, Pull-out strength of suture anchors for rotator cuff and Bankart lesion repairs, Nov.-Dec. 1993 , The American Journal of Sports Medicine, vol. 21 No. 6 p. 874-9. |
| Hernigou et al, Proximal Tibial Osteotomy for Osteoarthritis with Varus Deformity a Ten to Thirteen-Year Follow-Up Study, J Bone Joint Surg, vol. 69-A, No. 3. Mar. 1987, p. 332-354. |
| Ibarra et al, Glenoid Replacement in Total Shoulder Arthroplasty, The Orthopedic Clinics of Northamerica: Total Shoulder Arthroplasty, vol. 29 No. 3, Jul. 1998 p. 403-413. |
| Mosca et al, Calcaneal Lengthening for Valgus Deformity of the Hindfoot, Results in Children Who Had Severe, Symptomatic Flatfoot and Skewfoot, The Journal of bone and Joint Surgery, American vol. Apr. 1, 1995, pp. 499-512. |
| Murphycet al , Radial Opening Wedge Osteotomy in Madelung's Deformity, J. Hand Surg, vol. 21 A No. Nov. 6, 1996, p. 1035-44. |
| Biomet, Stanmore Modular Hip, J. Bone Joint Surg., vol. 76-B : No. Two, Mar. 1994. |
| 010-3 Copending U.S. Appl. No. 11/932,907—RCE Response Sep. 15, 2011. |
| 027 Copending U.S. Appl. No. 11/258,795 Non-Final Office Action mailed Apr. 26, 2011. |
| 046 Copending U.S. Appl. No. 11/689,670, RCE Response Sep. 19, 2011. |
| 003-1 Copending U.S. Appl. No. 10/614,352, Final Office Action Jul. 12, 2010. |
| 007-2 Copending U.S. Appl. No. 11/932,602 Final Response to Office Action Jun. 10, 2011. |
| 039 Copending U.S. Appl. No. 11/671,556 Response filed Aug. 23, 2010. |
| Co-pending U.S. Appl. No. 11/438,537, Supplemental Final Rejection mailed Sep. 25, 2009. |
| Petition for Inter Partes Review of U.S. Pat. No. 5,980,559, IPR 2013-00603, Filing Date Sep. 24, 2013. |
| Declaration of David Kaplan. Ph.D. Regarding U.S. Pat. No. 5,980,559, IPR 2013-00603, Sep. 24, 2013. |
| Petition for Inter Partes Review of U.S. Pat. No. 7,087,073, IPR 2013-00604, Filing Date Sep. 24, 2013. |
| Declaration of Wayne J. Sebastianelli, MD Regarding U.S. Pat. No. 7,087,073, Sep. 24, 2013, IPR 2013-00604. |
| Petition for Inter Partes Review of U.S. Pat. No. 6,500,195, IPR 2013-00624, Filing Date Oct. 2, 2013. |
| Declaration of Dr. Philip Hardy in Support of Petition for Inter Partes Review of U.S. Pat. No. 6,500,195, IPR 2013-00624, Sep. 25, 2013. |
| Petition for Inter Partes Review of U.S. Pat. No. 5,527,343, IPR 2013-00628, Filing Date Sep. 26, 2013,Sep. 25, 2013. |
| Declaration of Dr. Philip Hardy in Support of Petition for Inter Partes Review of U.S. Pat. No. 5,527,343, IPR 2013-00628, Sep. 25, 2013. |
| Corrected Petition for Inter Partes Review of U.S. Pat. No. 5,921,986, IPR 2013-00631, Filing Date Sep. 27, 2013. |
| Expert Declaration of Steve E. Jordan, MD, for Inter Partes Review of U.S. Pat. No. 5,921,986, IPR 2013-00631, Sep. 24, 2013. |
| Corrected Petition for Inter Partes Review of U.S. Pat. No. 8,147,514, IPR 2013-00632, Filing Date Sep. 27, 2013. |
| Declaration of Steve Jordan for U.S. Pat. No. 8,147,514, from IPR 2013-00632, dated Sep. 23, 2013 (exhibit 1009). |
| Corrected Petition for Inter Partes Review of U.S. Pat. No. 8,147,514, IPR 2013-00633, Filing Date Sep. 27, 2013. |
| Declaration of Steve Jordan for U.S. Pat. No. 8,147,514, from IPR 2013-00633, dated Sep. 23, 2013 (exhibit 1006). |
| Flory, Principles of Polymer Chemistry, 1953, selected pages (cited in IPR 2013-00603, exhibit 1012). |
| Grizzi, Hydrolytic degradation of devices based on poly(DL-lactic acid) size-dependence, Biomaterials, 1995, vol. 16, No. 4, p. 305-11 (cited in IPR 2013-00603, exhibit 1006). |
| Gopferich, Mechanisms of polymer degradation and erosion, Biomaterials, 1996, vol. 17, No. 2, p. 103-114 (cited in IPR 2013-00603, exhibit 1013). |
| Gao et el, Swelling of Hydroxypropyl Methylcellulose Matrix Tablets . . . , J. of Pharmaceutical Sciences, vol. 85, No. 7, Jul. 1996, p. 732-740 (cited in IPR 2013-00603, exhibit 1014). |
| Linvatec, Impact Suture Anchor brochure, 2004 (cited in IPR 2013-00628, exhibit 1010). |
| Seitz et al, Repair of the Tibiofibular Syndesmosis with a Flexible Implant, J. of Orthopaedic Trauma, vol. 5, No. 1, p. 78-82, 1991 (cited in IPR 2013-00631, exhibit 1007) (cited in IPR 2013-00632, exhibit 1004). |
| Translation of FR2696338 with translator's certificate dated Sep. 17, 2013 (cited in IPR 2013-00631, 2013-00632). |
| Translation of DE9002844.9 with translator's certificate dated Sep. 26, 2013 (cited in IPR 2013-00631, 2013-00632). |
| Declaration of Steve Jordan for U.S. Pat. No. 5,921,986, from IPR 2013-00632, dated Sep. 24, 2013 (exhibit 1010). |
| Declaration of Steve Jordan for U.S. Pat. No. 5,921,986, from IPR 2013-00633, dated Sep. 24, 2013 (exhibit 1007). |
| Declaration of Dr. Steve E. Jordan for U.S. Pat. No. 8,147,514, from IPR 2013-00631, dated Sep. 23, 2013. |
| The Search for the Holy Grail: A Centrury of Anterior Cruciate Ligament Reconstruction, R. John Naranja, American Journal of Orthopedics, Nov. 1997. |
| Femoral Bone Plug Recession in Endoscope Anterior Cruciate Ligament Reconstruction, David E. Taylor, Arthroscopy: The Journal of Arthroscopic and Related Surgery, Aug. 1996. |
| Meniscus Replacement with Bone Anchors: A Surgical Technique, Arthroscopy: The Journal of Arthroscopic and Related Surgery, 1994. |
| Problem Solving Report Question No. 1014984.066, Ultrasonic Welding, (c) 1999. |
| Guide to Ultrasound Plastic Assembly, Ultrasonic Division Publication, (c) 1995. |
| Branson, Polymers: Characteristics and Compatibility for Ultrasonic Assembly, Applied Technologies Group, Jan. 2006. |
| Enabling Local Drug Delivery-Implant Device Combination Therapies, Surmodics, Inc., (c) 2003. |
| Stent Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model, Takeshi Suzuki, American Heart Association, Inc. (c) 2001. |
| Why Tie a Knot When You Can Use Y-Knot?, Innovasive Devices Inc., (c) 1998. |
| Ask Oxford, compact Oxford English dictionary: projection, Mar. 30, 2009. |
| Ask Oxford, compact Oxford English dictionary: slit, Mar. 30, 2009. |
| Textured Surface Technology, Branson Technolog, Branson Ultrasonics Copr., (c) 1992. |
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| 60622095 | Oct 2004 | US |
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