US20080294256A1 - Methods and Materials for Connective Tissue Repair - Google Patents

Methods and Materials for Connective Tissue Repair Download PDF

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US20080294256A1
US20080294256A1 US12/185,519 US18551908A US2008294256A1 US 20080294256 A1 US20080294256 A1 US 20080294256A1 US 18551908 A US18551908 A US 18551908A US 2008294256 A1 US2008294256 A1 US 2008294256A1
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matrix material
scaffolding matrix
tendon
scaffolding
end portion
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US12/185,519
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Cary P. Hagan
Rick P. Swaim
Kelly W. Schlachter
James J. Chao
Hungnan Lo
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1146Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of tendons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • A61F2002/0847Mode of fixation of anchor to tendon or ligament
    • A61F2002/087Anchor integrated into tendons, e.g. bone blocks, integrated rings

Definitions

  • This invention is generally directed to methods and materials for connective tissue repair.
  • the invention is more specifically related to methods and materials for the repair of tendons and ligaments.
  • Connective tissue in a person may rupture or tear for various reasons, including trauma, and therefore need to be repaired. Numerous methods and materials for repairing soft tissue have been proposed. As used herein, “connective tissue”, generally refers to tendon and ligament.
  • Adhesives have also been proposed for tendon repair. See e.g. US Pub 2002/0161400. Similarly, photochemical treatments have been proposed. See e.g. US Pub 2002/0187935.
  • ACL anterior cruciate ligament
  • PCL posterior cruciate ligament
  • ACL anterior cruciate ligament
  • PCL posterior cruciate ligament
  • that repair involved the complete replacement of the remaining connective tissue with a graft of either autologous tendon harvested from patellar ligament or some other graft material.
  • the graft may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • a method for repairing a tendon comprising the steps of: accessing an end of a first tendon; accessing an end of a second tendon; extra-operatively obtaining a scaffolding matrix; joining the ends of the first and second tendons using the scaffolding matrix.
  • a material for use in connective tissue repair comprising: an extra-operatively obtained scaffolding matrix, the matrix having a height, width, and length; the length being substantially greater than the width and the height; and the height and width being dimensioned such that said matrix may be sewn inside a tendon.
  • a method of repairing a ligament comprising the steps of: accessing a first bone portion; accessing a second bone portion; accessing a ligament that should attach the first and second bone portions, but has come detached from one of the first and second bone portions; providing an extra-operatively obtained scaffolding matrix having first and second ends; attaching one end of the scaffolding matrix to the bone portions from which the ligament has become detached; attaching the scaffolding matrix to the ligament.
  • a method of rotator cuff repair comprising the steps of: accessing the proximal humerus; accessing the scapula; providing a scaffolding matrix having first and second ends and at least one bone block on an end thereof; attaching the end of the scaffolding matrix having the bone block to the proximal humerus; attaching the other end of the scaffolding matrix to the scapula.
  • FIG. 1 depicts a severed or ruptured tendon for repair with the various aspects of the method according to the invention.
  • FIGS. 2A-C depict how a tunnel may be cored through the end of the ruptured or severed tendon for receipt of a scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 3 depicts how the scaffolding matrix may be introduced and pulled through the tunnel cored through the ends of the ruptured or severed tendon according to the various aspects of the method according to the invention.
  • FIG. 4 depicts how a tunnel may be cored through the end of the other ruptured or severed tendon for receipt of a scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 5 depicts how the scaffolding matrix may be introduced and pulled through the tunnel cored through the end of the other ruptured or severed tendon according to the various aspects of the method according to the invention.
  • FIG. 6 depicts how the two ends of tendon are re-approximated and the scaffolding matrix pulled taught according to the various aspects of the method according to the invention.
  • FIG. 7 depicts a first step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIG. 8 depicts a second step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIG. 9 depicts a third step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIGS. 10A , 10 B, and 10 C depict alternative embodiments for stitching the scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 11 depicts yet another alternative embodiment for stitching the scaffolding matrix according to the various aspects of the method according to the invention.
  • FIGS. 12A , 12 B depict how the method according to the invention provides benefits over conventional methods with respect to tendon tears that cannot be re-approximated.
  • FIG. 13 depicts how the method according to the invention provides benefits over conventional suturing methods.
  • FIG. 14 depicts a separated finger ligament that may be repaired using the method according to the various aspects of the invention.
  • FIG. 15 depicts the ligament of FIG. 14 after being repaired using the method according to the various aspects of the invention.
  • FIGS. 16A-16D depict various aspects of an exemplary embodiment of the invention suitable for use in rotator cuff repair.
  • FIG. 17 depicts an exemplary embodiment of the invention suitable for use in rotator cuff repair through a closed arthroscopic approach.
  • FIGS. 18A-18C depict various views of the embodiments of FIGS. 16A-16D being used to repair a rotator cuff.
  • a tendon 10 has been severed or ruptured into a first end portion 10 a and a second end portion 10 b of a tendon 10 and are in need of repair by re-connection of the two ends.
  • These tendon end portions 10 a , 10 b may be located anywhere in the body and accessed via conventional surgical techniques.
  • Tendons, such as tendon 10 are typically in the form of bundles of collagen fibers embedded in a connecting matrix, known as ground substance, provide the load carrying elements of natural tendons and ligaments. The arrangement of the collagen fibers is nearly parallel in tendons, equipping them to withstand high unidirectional loads.
  • the ground substance in both tendons and ligaments acts generally as a cementing matrix holding the collagen fibers together.
  • the ground substance retains large amounts of water essential to the non-compressive hydraulic function of the moving tissue.
  • elastic fibers tenocytes, small blood vessels and nerves (none shown).
  • the cellular material fibroblasts
  • the ground substance matrix accounts for the remaining 62% to 80%.
  • About 70% of the ground substance matrix consists of water absorbed in an open polysaccharide matrix.
  • the tendon ends will start to form frayed end portions 11 as the collagen fibers that make up tendon 10 start to separate from one another due to trauma and lack of blood.
  • an extra-operatively obtained scaffolding matrix is used to connect the first and second end portions 10 a , 10 b .
  • extra-operatively obtained means not obtained by the surgical group currently performing the procedure or parties related to that group. Accordingly, extra-operatively is intended to exclude grafts obtained by such conventional procedures as autograft or allograft (where the graft is harvested at the same or near the same time as the surgery according to the invention—see below). Through the revascularization and repopulation of the scaffolding matrix the natural healing of the tendon 10 will be accelerated.
  • the scaffolding matrix is threaded through the first and second tendon end portions 10 a , 10 b , of the ruptured or severed tendon 10 and, if there is enough tendon available, then manipulated to bring the first and second tendon end portions into contact with each other (this is known as “re-approximation”). Additional suturing, using conventional suture, may then be carried out to further secure the ends of the tendon together.
  • Step 1 As shown in FIGS. 2A-C , a ball probe 50 or tendon retriever 100 ( FIG. 3 ) is used to core a tunnel 20 a through the first tendon end portion 10 a towards the severed or ruptured end 13 a .
  • An approach that enters the tendon end portion 10 a through its lateral walls 12 a and leads towards the severed or ruptured end 13 a is preferred so as to not further fray the fibrous tendon. Further fraying of the end of the tendon is why it is believed that splint methods where the splints are inserted into the frayed ends of the tendon, such as shown in U.S. Pat. No. 5,723,003 and US Pub 2002/0161400, have not found a wide following.
  • Step 2 A conventional tendon retriever 100 is used to grasp an end of the scaffolding matrix M and introduce it into and pull it back through the tunnel 20 a in the end of the first tendon portion 10 a ( FIG. 3 ).
  • Step 3 As with the first tendon end portion 10 a , a ball probe or tendon retriever is used to core a tunnel 20 b through the second tendon portion 10 b towards the severed or ruptured end 13 b . ( FIG. 4 ).
  • Step 4 A tendon retriever 100 is used to grasp the other end of the scaffolding matrix M and pull it back through the tunnel 20 b in the end of the second tendon portion 10 b . ( FIG. 5 ).
  • Step 5 The ends of the two tendon portions 13 a , 13 b are re-approximated and the scaffolding matrix M is pulled taught. ( FIG. 6 ).
  • Step 6 Suture 60 is used to anchor the scaffolding matrix M and temporarily hold the end portions 10 a , 10 b of tendon 10 together while the scaffolding matrix M assists and accelerates the natural healing of the tendon 10 .
  • Kessler's suture method has been found to work well with the method of the invention. However, the invention is not limited to use of the Kessler method, as will be described.
  • the first transverse stitch 60 a of the Kessler pattern should be passed through and penetrate the scaffolding matrix M, such as at point 60 b ( FIG. 7 ).
  • Conventional suture such as 4.0 Ethibond® suture may be used for this purpose.
  • the suture repair is made in a similar manner on both sides of the tendon tear (e.g. suture 60 passes through and penetrates scaffolding matrix M at point 60 c ).
  • Step 7 The final knot 60 d in the suture 60 is buried in the epitedineum of the tendon under lateral wall 11 b and the scaffolding matrix M is cut flush with the tendon 10 by cutting off the excess portions of the scaffolding matrix M before and after 60 a , 60 b , respectively ( FIG. 8 ).
  • Step 8 A final stitch is made circumferentially around the tendon tear.
  • Conventional suture 61 such as 6.0 BV Monofilament may be used for this purpose ( FIG. 9 ).
  • the scaffolding matrix has been in the form of Graftjacket® acellular matrix, sold by Wright Medical Technology, Inc., of Arlington, Tenn., and manufactured according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.
  • This product consists of a selectively preserved extracellular protein matrix that is devoid of certain viable cells which normally express major histocompatibility complex antigenic determinants and other antigens which would be recognized as foreign by the recipient.
  • This extracellular protein matrix is made up of collagen and other proteins and provides a structural template which may be repopulated with new viable cells that would not be rejected by the host. With this material complications following implantation (including but not limited to immunorejection, contracture, calcification, occlusion, and infection) are significantly reduced relative to current implant procedures and materials.
  • the scaffolding matrix when made from this particular material, should have a width of about 2 mm and a height of about 2 mm. Length is variable and depends upon the amount of stitching required. But, in general the material will be in strip form where the length is substantially greater than both the width and height.
  • a scaffolding matrix such as that described above (i.e., an acellular scaffolding matrix)
  • an acellular scaffolding matrix not only are the harvesting complications and morbidity concerns of autograft non-issues, so are the immediacy and tissue matching concerns of allograft.
  • acellular biological materials such as that described above have shelf lives of two years, thereby alleviating immediacy concerns.
  • unknown source means unknown source with respect to the parties implanting the scaffolding matrix as a graft and not necessarily the parties harvesting the original material and then processing it according to, e.g., the various accularization processes. The latter will, of course, rigorously monitor where the graft originates and certify its processing. Therefore, typically the scaffolding matrix will be an off-the-shelf material and not obtained as a step in the tendon repair process or in response to a request of the tendon repair process. Rather, the material will be sitting on the shelf waiting to be used and any package of material may be taken off the shelf with out the need to match with respect to the recipient's tissue type, etc.
  • scaffolding matrix should be interpreted as any non-autograft or non-allograft (i.e., fresh) material capable of revascularization and repopulation by cells, especially connective tissue.
  • non-autograft or non-allograft i.e., fresh
  • connective tissue Typically the material with be off-the-shelf material rather than harvested or produced as needed. It would also be beneficial if the material was strong.
  • revascularization and the ability to be repopulated are more important to the fast healing of ruptured, severed, or torn tendons.
  • the scaffolding matrix need not even be from a human source. Graft materials from non-human sources, such as porcine, have been proposed. See e.g., U.S. Pat. No. 6,206,931.
  • the scaffolding matrix need not even be organic.
  • synthetic porous materials capable of connective tissue in-growth may be used. See e.g. U.S. Pat. No. 5,258,040.
  • the method according to the invention has been described as applicable to any tendon, the method is especially beneficial to the flexor tendons of the hand. This is due to the fact that the method involves placing the scaffolding matrix inside the tendon end portions and therefore does not add any bulk to the outside of the repaired tendons. Accordingly, the method should not inhibit the movement of the repaired tendons through the pulleys of the hand. As mentioned above, this is a problem with many prior art methods. See e.g. USP U.S. Pat. No. 5,800,544; U.S. Pat. No. 6,080,192; U.S. Pat. No. 6,106,556.
  • the scaffolding matrix M may be used by itself with: Kienert's ( FIG. 10A ), Bunuell's ( FIG. 10B ), or Kessler's ( FIG. 10C ) methods. Additionally, as experience with these scaffolding matrices and stitching and manipulating them grows, specific new methods of stitching them may be developed.
  • FIGS. 12A , 12 B, and 13 depict additional benefits of the various aspects of the method according to the invention.
  • FIGS. 12A and 12B depict how the method according to the invention provides benefits over conventional methods with respect to tendon tears that cannot be re-approximated.
  • a gap d 1 will exist between them ( FIG. 12A ). If this gap d 1 is spanned by a material not capable of revascularization, repopulation and tissue ingrowth, such as suture, the two tendon end portions may be mechanically connected, but new connective tissue will never fill the gap d 1 and the tendon will never repair to anywhere near its full strength or functionality.
  • FIG. 13 depicts how the method according to the invention provides benefits over conventional suturing methods.
  • suture connections may come loose if not fixated properly.
  • the two severed or ruptured end portions 10 a , 10 b of the tendon 10 may start to move apart, such as in the direction of arrows A.
  • a scaffolding matrix M capable of revascularization, repopulation and connective tissue ingrowth as discussed immediately above is used, even as a gap between the tendon end portions starts to form, natural healing can continue.
  • the scaffolding matrix is one that provides for strength in excess to that of suture, the scaffolding matrix will act to keep the tendon end portions 10 a , 10 b together even as the suture may loosen.
  • the graft may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • FIG. 14 shows a separated finger ligament.
  • the ligament 200 that would normally connect bones 210 and 220 has separated from its insertion point 215 , while remaining connected to bone at its origin 217 .
  • the ligament 200 will begin to atrophy and shrink due to a lack of tension thereon.
  • a piece of extra-operatively obtained scaffolding matrix M will be attached to the bone 220 at the original ligament 200 insertion point 215 .
  • the use of extra-operatively obtained scaffolding matrix M will provide for all the benefits described with respect to tendon repair above.
  • the scaffolding matrix M will be ran parallel to the existing ligament and attached thereto such as by suture 60 , using any known method ( FIG. 15 ).
  • the ligament 200 /scaffolding matrix M combination will now act as a complete natural ligament and give the finger back at least some of its natural movement. Furthermore, as the scaffolding matrix M becomes repopulated with connective tissue and begins to remodel itself to be more like connective tissue, the finger will begin to function even better.
  • scaffolding matrix M When used for this application, scaffolding matrix M will typically be about 2 mm high by 3 mm wide. Again, length may vary depending upon the application and need.
  • the doctor may chose to reinforce the ligament/scaffolding matrix combination by attaching it to both bones and not just the bone from which the ligament detatched (e.g. also attach to the origin 217 in FIG. 15 above).
  • the scaffolding matrix M according to the invention may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • Scaffolding matrix M may be used for major tendon/ligament tears, such as in the rotator cuff of the shoulder.
  • Materials useful for this purpose are shown in FIGS. 16A-16D . These materials comprise a sheet of scaffolding matrix M attached on one ( FIGS. 16A , B) or both ( FIGS. 16C , D) of its ends with a bone block.
  • the bone block will be made from a bone material which has been thoroughly processed so as to eliminate tissue typing and pathogenic disease issues. Methods of producing such bone material and attaching it to materials similar to scaffolding matrix M are disclosed in, for example, U.S. Pat. No. 4,597,766; U.S. Pat. No.
  • one or both of the bone blocks may have screw holes 210 drilled therethrough to provide for additional fixation of the bone block to its fixation point.
  • FIG. 17 shows an embodiment especially suitable for use in arthroscopic rotator cuff repairs.
  • scaffolding matrix M has a main portion and then splits towards its end into a number of fingers M′.
  • Each finger M′ will have its own bone block 220 , rather than one bone block span the entire width of scaffolding matrix M. This allows the entire scaffolding matrix/bone block construct to be rolled up and fed through an arthroscope canula.
  • FIGS. 18A-C depict different ways in which these various embodiments may be used in rotator cuff repair.
  • bone block 200 is seated within a groove made in the proximal humerus H.
  • a press-fit connection may be used that is supplemented by screws 250 .
  • Scaffolding matrix M spans humeral head and is fixed to the scapula S via k-wires K.
  • FIG. 18C there is also a bone block on the proximal end of scaffolding matrix M and that bone block is also attached to scapula S by K-wires K.

Abstract

Methods for tendon and ligament repair using a scaffolding matrix material. The scaffolding matrix material is an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens, and to promote natural healing of soft tissue via revascularization and repopulation. The scaffolding matrix material is used to join ruptured tendons or ligaments together and to join ligaments to bone.

Description

    CROSS REFERENCE TO RELATED APPLICATIONS
  • This application is a continuation of and claims priority to application Ser. No. 10/845,402, filed May 13, 2004, which is pending.
  • FIELD OF THE INVENTION
  • This invention is generally directed to methods and materials for connective tissue repair. The invention is more specifically related to methods and materials for the repair of tendons and ligaments.
  • BACKGROUND OF THE INVENTION
  • Connective tissue in a person may rupture or tear for various reasons, including trauma, and therefore need to be repaired. Numerous methods and materials for repairing soft tissue have been proposed. As used herein, “connective tissue”, generally refers to tendon and ligament.
  • Today, the most common methods of repairing torn, severed or otherwise damaged tendons involve approximating the severed ends of the tendons and suturing one side of the tendon to the other thereby returning the tendon to its natural position. A popular suture technique is the so-called Kessler technique and modifications thereof. Some of the other techniques include the Becker, Savage, lateral trap, double loop locking suture, four-strand interlock and variations of the Halsted technique.
  • Other current methods of tendon repair place prosthetic material either within or around the tendon or employ mechanical fasteners to the ends of the fasteners to reinforce the suture/tendon interface to provide a stronger repair. See e.g. U.S. Pat. No. 5,800,544; U.S. Pat. No. 6,080,192; U.S. Pat. No. 6,106,556, all of which are incorporated by reference herein as are all patents and published patent applications cited herein. However, these methods often may add bulk to the tendon which can result in problems with tendons that are in closely packed areas such as the hand.
  • Adhesives have also been proposed for tendon repair. See e.g. US Pub 2002/0161400. Similarly, photochemical treatments have been proposed. See e.g. US Pub 2002/0187935.
  • Various methods of placing a sleeve around the ends of the ruptured tendon have been proposed for acting as a support for suture. See e.g. USP U.S. Pat. No. 4,469,101; U.S. Pat. No. 5,147,400; U.S. Pat. No. 5,749,895; U.S. Pat. No. 5,897,591; U.S. Pat. No. 6,206,931; WO96/07355.
  • Alternatively, a method of placing a sleeve around the ends of the ruptured tendon has been proposed in which the sleeve has teeth thereon for attaching itself to the ends of the tendons. See e.g. U.S. Pat. No. 6,485,503; US Pub 2003/0069602; WO01/89392.
  • Finally, a method in which a metal insert is inserted into the ruptured ends of the tendon has been proposed. See e.g. U.S. Pat. No. 5,723,008; US Pub 2002/0161400.
  • In the art of ligament repair, the focus has been on the knee and in particular, the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL). See e.g. U.S. Pat. No. 6,616,694; U.S. Pat. No. 6,497,726; U.S. Pat. No. 5,078,744; U.S. Pat. No. 4,597,766; EP 278,713. Typically, that repair involved the complete replacement of the remaining connective tissue with a graft of either autologous tendon harvested from patellar ligament or some other graft material. The graft may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • Finally, methods of rotator cuff and shoulder muscle repair have been proposed. See e.g. US Pub. 2003/0212456; FR 2,810,877; FR 2,690,073; FR 2,638,349; FR 2,748,652.
  • However, none of these various proposals of connective tissue repair have found a wide following.
  • Accordingly, there is room for improvement within the art.
  • OBJECTS OF THE INVENTION
  • It is an object of the invention to provide a method and material for connective tissue repair.
  • It is a further object of the invention to provide a method and material for connective tissue repair using an extra-operatively obtained scaffolding matrix.
  • It is a further object of the invention to provide a method and material for connective tissue repair using an extra-operatively obtained scaffolding matrix and that does not add bulk to the repaired connective tissue, especially when the connective tissue is tendon.
  • It is a further object of the invention to provide a method and material for connective tissue repair using an extra-operatively obtained scaffolding matrix that is especially suitable for use in the hand.
  • These and other objects of the invention are achieved by a method for repairing a tendon, comprising the steps of: accessing an end of a first tendon; accessing an end of a second tendon; extra-operatively obtaining a scaffolding matrix; joining the ends of the first and second tendons using the scaffolding matrix.
  • These and other objects of the invention are achieved by a material for use in connective tissue repair, comprising: an extra-operatively obtained scaffolding matrix, the matrix having a height, width, and length; the length being substantially greater than the width and the height; and the height and width being dimensioned such that said matrix may be sewn inside a tendon.
  • These and other objects of the invention are achieved by a method of repairing a ligament, comprising the steps of: accessing a first bone portion; accessing a second bone portion; accessing a ligament that should attach the first and second bone portions, but has come detached from one of the first and second bone portions; providing an extra-operatively obtained scaffolding matrix having first and second ends; attaching one end of the scaffolding matrix to the bone portions from which the ligament has become detached; attaching the scaffolding matrix to the ligament.
  • These and other objects of the invention are achieved by a method of rotator cuff repair, comprising the steps of: accessing the proximal humerus; accessing the scapula; providing a scaffolding matrix having first and second ends and at least one bone block on an end thereof; attaching the end of the scaffolding matrix having the bone block to the proximal humerus; attaching the other end of the scaffolding matrix to the scapula.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 depicts a severed or ruptured tendon for repair with the various aspects of the method according to the invention.
  • FIGS. 2A-C depict how a tunnel may be cored through the end of the ruptured or severed tendon for receipt of a scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 3 depicts how the scaffolding matrix may be introduced and pulled through the tunnel cored through the ends of the ruptured or severed tendon according to the various aspects of the method according to the invention.
  • FIG. 4 depicts how a tunnel may be cored through the end of the other ruptured or severed tendon for receipt of a scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 5 depicts how the scaffolding matrix may be introduced and pulled through the tunnel cored through the end of the other ruptured or severed tendon according to the various aspects of the method according to the invention.
  • FIG. 6 depicts how the two ends of tendon are re-approximated and the scaffolding matrix pulled taught according to the various aspects of the method according to the invention.
  • FIG. 7 depicts a first step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIG. 8 depicts a second step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIG. 9 depicts a third step in securing the scaffolding matrix to the ends of tendon according to the various aspects of the method according to the invention.
  • FIGS. 10A, 10B, and 10C depict alternative embodiments for stitching the scaffolding matrix according to the various aspects of the method according to the invention.
  • FIG. 11 depicts yet another alternative embodiment for stitching the scaffolding matrix according to the various aspects of the method according to the invention.
  • FIGS. 12A, 12B depict how the method according to the invention provides benefits over conventional methods with respect to tendon tears that cannot be re-approximated.
  • FIG. 13 depicts how the method according to the invention provides benefits over conventional suturing methods.
  • FIG. 14 depicts a separated finger ligament that may be repaired using the method according to the various aspects of the invention.
  • FIG. 15 depicts the ligament of FIG. 14 after being repaired using the method according to the various aspects of the invention.
  • FIGS. 16A-16D depict various aspects of an exemplary embodiment of the invention suitable for use in rotator cuff repair.
  • FIG. 17 depicts an exemplary embodiment of the invention suitable for use in rotator cuff repair through a closed arthroscopic approach.
  • FIGS. 18A-18C depict various views of the embodiments of FIGS. 16A-16D being used to repair a rotator cuff.
  • DETAILED DESCRIPTION OF THE INVENTION
  • With reference to the above-mentioned drawings, an exemplary embodiment of methods and materials for connective tissue repair that meets and achieves the various objects set forth above will now be described.
  • Tendon Repair
  • For example, in FIG. 1, a tendon 10 has been severed or ruptured into a first end portion 10 a and a second end portion 10 b of a tendon 10 and are in need of repair by re-connection of the two ends. These tendon end portions 10 a, 10 b may be located anywhere in the body and accessed via conventional surgical techniques. Tendons, such as tendon 10, are typically in the form of bundles of collagen fibers embedded in a connecting matrix, known as ground substance, provide the load carrying elements of natural tendons and ligaments. The arrangement of the collagen fibers is nearly parallel in tendons, equipping them to withstand high unidirectional loads. The less parallel arrangement of the collagen fibers in ligaments allows these structures to sustain predominant tensile stresses in one direction and smaller stresses in other directions. The ground substance in both tendons and ligaments acts generally as a cementing matrix holding the collagen fibers together. The ground substance retains large amounts of water essential to the non-compressive hydraulic function of the moving tissue. Also included in the tendon composition are elastic fibers, tenocytes, small blood vessels and nerves (none shown). In general, the cellular material (fibroblasts) occupies about 20% to 38% depending on references, of the total tissue volume, while the ground substance matrix accounts for the remaining 62% to 80%. About 70% of the ground substance matrix consists of water absorbed in an open polysaccharide matrix. Typically, when a tendon is severed, ruptured, or torn, the tendon ends will start to form frayed end portions 11 as the collagen fibers that make up tendon 10 start to separate from one another due to trauma and lack of blood.
  • In summary, according to preferred method of the invention, an extra-operatively obtained scaffolding matrix is used to connect the first and second end portions 10 a, 10 b. As used herein, and will be described in more detail below, “extra-operatively obtained”, means not obtained by the surgical group currently performing the procedure or parties related to that group. Accordingly, extra-operatively is intended to exclude grafts obtained by such conventional procedures as autograft or allograft (where the graft is harvested at the same or near the same time as the surgery according to the invention—see below). Through the revascularization and repopulation of the scaffolding matrix the natural healing of the tendon 10 will be accelerated.
  • Furthermore, in summary, according to the invention, the scaffolding matrix is threaded through the first and second tendon end portions 10 a, 10 b, of the ruptured or severed tendon 10 and, if there is enough tendon available, then manipulated to bring the first and second tendon end portions into contact with each other (this is known as “re-approximation”). Additional suturing, using conventional suture, may then be carried out to further secure the ends of the tendon together.
  • The details of the method are set forth as follows.
  • Step 1—As shown in FIGS. 2A-C, a ball probe 50 or tendon retriever 100 (FIG. 3) is used to core a tunnel 20 a through the first tendon end portion 10 a towards the severed or ruptured end 13 a. An approach that enters the tendon end portion 10 a through its lateral walls 12 a and leads towards the severed or ruptured end 13 a is preferred so as to not further fray the fibrous tendon. Further fraying of the end of the tendon is why it is believed that splint methods where the splints are inserted into the frayed ends of the tendon, such as shown in U.S. Pat. No. 5,723,003 and US Pub 2002/0161400, have not found a wide following.
  • Step 2—A conventional tendon retriever 100 is used to grasp an end of the scaffolding matrix M and introduce it into and pull it back through the tunnel 20 a in the end of the first tendon portion 10 a (FIG. 3).
  • Step 3—As with the first tendon end portion 10 a, a ball probe or tendon retriever is used to core a tunnel 20 b through the second tendon portion 10 b towards the severed or ruptured end 13 b. (FIG. 4).
  • Step 4—A tendon retriever 100 is used to grasp the other end of the scaffolding matrix M and pull it back through the tunnel 20 b in the end of the second tendon portion 10 b. (FIG. 5).
  • Step 5—The ends of the two tendon portions 13 a, 13 b are re-approximated and the scaffolding matrix M is pulled taught. (FIG. 6).
  • Step 6—Suture 60 is used to anchor the scaffolding matrix M and temporarily hold the end portions 10 a, 10 b of tendon 10 together while the scaffolding matrix M assists and accelerates the natural healing of the tendon 10. Kessler's suture method has been found to work well with the method of the invention. However, the invention is not limited to use of the Kessler method, as will be described. Typically, the first transverse stitch 60 a of the Kessler pattern should be passed through and penetrate the scaffolding matrix M, such as at point 60 b (FIG. 7). Conventional suture, such as 4.0 Ethibond® suture may be used for this purpose. The suture repair is made in a similar manner on both sides of the tendon tear (e.g. suture 60 passes through and penetrates scaffolding matrix M at point 60 c).
  • Step 7—The final knot 60 d in the suture 60 is buried in the epitedineum of the tendon under lateral wall 11 b and the scaffolding matrix M is cut flush with the tendon 10 by cutting off the excess portions of the scaffolding matrix M before and after 60 a, 60 b, respectively (FIG. 8).
  • Step 8—A final stitch is made circumferentially around the tendon tear. Conventional suture 61, such as 6.0 BV Monofilament may be used for this purpose (FIG. 9).
  • According to the preferred method of the invention, the scaffolding matrix has been in the form of Graftjacket® acellular matrix, sold by Wright Medical Technology, Inc., of Arlington, Tenn., and manufactured according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616. This product consists of a selectively preserved extracellular protein matrix that is devoid of certain viable cells which normally express major histocompatibility complex antigenic determinants and other antigens which would be recognized as foreign by the recipient. This extracellular protein matrix is made up of collagen and other proteins and provides a structural template which may be repopulated with new viable cells that would not be rejected by the host. With this material complications following implantation (including but not limited to immunorejection, contracture, calcification, occlusion, and infection) are significantly reduced relative to current implant procedures and materials.
  • Preferably, the scaffolding matrix, when made from this particular material, should have a width of about 2 mm and a height of about 2 mm. Length is variable and depends upon the amount of stitching required. But, in general the material will be in strip form where the length is substantially greater than both the width and height.
  • In the past, doctors have been known to use fresh autograft and even allograft to make repairs similar to those described above. While it is not clear if such materials can be deemed “scaffolding matrices” because they are used more for their fixation properties than their repopulation properties, clearly, each of these pose their own problems. Autograft, while not prone to causing immune responses, is prone to causing complications and morbidity issues at the graft harvesting site and may not be possible in situations where poor tissue is found at typical harvest locations or the patient has other diseases that may result in poor harvesting ability. Allograft faces the primary hurdle of immune response issues in the recipient and therefore requires tissue matching between the donor and the recipient. Furthermore, typically the allograft is harvested from an identified donor on an as needed basis and if a proper donor or tissue type is not found at the time they are needed, the patient in the need of the graft will not be able to have one.
  • However, with a scaffolding matrix such as that described above (i.e., an acellular scaffolding matrix), not only are the harvesting complications and morbidity concerns of autograft non-issues, so are the immediacy and tissue matching concerns of allograft. Additionally, typically, acellular biological materials such as that described above have shelf lives of two years, thereby alleviating immediacy concerns. Furthermore, there is no need for anyone related to the tendon repair procedure to have any knowledge of the source of the scaffolding matrix, i.e., where or when it was harvested. In other words, the scaffolding matrix will be obtained extra-operatively and from an unknown source. Accordingly, as used herein, “unknown source” means unknown source with respect to the parties implanting the scaffolding matrix as a graft and not necessarily the parties harvesting the original material and then processing it according to, e.g., the various accelularization processes. The latter will, of course, rigorously monitor where the graft originates and certify its processing. Therefore, typically the scaffolding matrix will be an off-the-shelf material and not obtained as a step in the tendon repair process or in response to a request of the tendon repair process. Rather, the material will be sitting on the shelf waiting to be used and any package of material may be taken off the shelf with out the need to match with respect to the recipient's tissue type, etc.
  • As described, the method according to the invention has been discussed in the context of use with a performed form of an organic scaffolding matrix. However, various scaffolding matrices some of which have not yet been developed may be used. Accordingly, as used herein scaffolding matrix should be interpreted as any non-autograft or non-allograft (i.e., fresh) material capable of revascularization and repopulation by cells, especially connective tissue. Typically the material with be off-the-shelf material rather than harvested or produced as needed. It would also be beneficial if the material was strong. However, revascularization and the ability to be repopulated are more important to the fast healing of ruptured, severed, or torn tendons.
  • The scaffolding matrix need not even be from a human source. Graft materials from non-human sources, such as porcine, have been proposed. See e.g., U.S. Pat. No. 6,206,931.
  • Additionally, the scaffolding matrix need not even be organic. For example, synthetic porous materials capable of connective tissue in-growth may be used. See e.g. U.S. Pat. No. 5,258,040.
  • While the method according to the invention has been described as applicable to any tendon, the method is especially beneficial to the flexor tendons of the hand. This is due to the fact that the method involves placing the scaffolding matrix inside the tendon end portions and therefore does not add any bulk to the outside of the repaired tendons. Accordingly, the method should not inhibit the movement of the repaired tendons through the pulleys of the hand. As mentioned above, this is a problem with many prior art methods. See e.g. USP U.S. Pat. No. 5,800,544; U.S. Pat. No. 6,080,192; U.S. Pat. No. 6,106,556.
  • While the preferred form of the method according to the invention has been described above with respect to the use of suture to supplement and secure the scaffolding matrix to the ruptured ends of the tendon while the natural healing process takes place and is accelerated, that is not required. Indeed, doctors may choose to use the scaffolding matrix M in place of suture entirely. In such situations, doctors may treat the scaffolding matrix M as suture and use it with any known suturing method. For example, as shown in FIGS. 10A-C, the scaffolding matrix M may be used by itself with: Kienert's (FIG. 10A), Bunuell's (FIG. 10B), or Kessler's (FIG. 10C) methods. Additionally, as experience with these scaffolding matrices and stitching and manipulating them grows, specific new methods of stitching them may be developed.
  • Furthermore, in yet other embodiments of the method according to the invention, it is possible to run the scaffolding matrix M two or more times back through the end portions 10 a, 10 b of the tendon 10 (FIG. 11).
  • FIGS. 12A, 12B, and 13 depict additional benefits of the various aspects of the method according to the invention.
  • For example, FIGS. 12A and 12B depict how the method according to the invention provides benefits over conventional methods with respect to tendon tears that cannot be re-approximated. In such situations, due to either damaged tendon tissue that had to be excised or various other reasons, even the two end portions 10 a, 10 b of the tendon 10 are pulled to their natural tension; a gap d1 will exist between them (FIG. 12A). If this gap d1 is spanned by a material not capable of revascularization, repopulation and tissue ingrowth, such as suture, the two tendon end portions may be mechanically connected, but new connective tissue will never fill the gap d1 and the tendon will never repair to anywhere near its full strength or functionality. However, by use of the scaffolding matrix M, especially spanning from the inside of one tendon portion to the inside of the other tendon portion, new connective tissue C will begin to first repopulate the scaffolding matrix M (FIG. 12A) and then grow and build upon the scaffolding matrix M. This will lead, eventually, to the gap d1 being completely filled with new connective tissue C (FIG. 12B) and the tendon being repaired to a strength far in excess to that it would have otherwise achieved without the use of the scaffolding matrix M.
  • FIG. 13 depicts how the method according to the invention provides benefits over conventional suturing methods. In particular, it is known that suture connections may come loose if not fixated properly. In such cases, the two severed or ruptured end portions 10 a, 10 b of the tendon 10 may start to move apart, such as in the direction of arrows A. However, if a scaffolding matrix M capable of revascularization, repopulation and connective tissue ingrowth as discussed immediately above is used, even as a gap between the tendon end portions starts to form, natural healing can continue. Additionally, if the scaffolding matrix is one that provides for strength in excess to that of suture, the scaffolding matrix will act to keep the tendon end portions 10 a, 10 b together even as the suture may loosen.
  • Ligament Repair
  • In the art of ligament repair, as previously mentioned, the focus has been on the knee and in particular, the ACL and the PCL. See e.g. U.S. Pat. No. 6,497,726. Typically, that repair involved the complete replacement of the remaining connective tissue with a graft. The graft may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • While such methods may be acceptable for larger joints such as the knee, simplified methods may be preferred in smaller joints, such as finger joints.
  • For example, FIG. 14, shows a separated finger ligament. In particular, in this example, the ligament 200 that would normally connect bones 210 and 220 has separated from its insertion point 215, while remaining connected to bone at its origin 217. Typically, after this occurs, as shown, the ligament 200 will begin to atrophy and shrink due to a lack of tension thereon.
  • According to the preferred method of the invention, after the bones 210 and 220 and ligament 200 are accessed via conventional surgical procedures, a piece of extra-operatively obtained scaffolding matrix M will be attached to the bone 220 at the original ligament 200 insertion point 215. The use of extra-operatively obtained scaffolding matrix M will provide for all the benefits described with respect to tendon repair above.
  • The scaffolding matrix M will be ran parallel to the existing ligament and attached thereto such as by suture 60, using any known method (FIG. 15). The ligament 200/scaffolding matrix M combination will now act as a complete natural ligament and give the finger back at least some of its natural movement. Furthermore, as the scaffolding matrix M becomes repopulated with connective tissue and begins to remodel itself to be more like connective tissue, the finger will begin to function even better.
  • When used for this application, scaffolding matrix M will typically be about 2 mm high by 3 mm wide. Again, length may vary depending upon the application and need.
  • While it has been suggested to use acellular graft materials to span bones, such has been done where movement between the bones has been wanted to be limited, see e.g. US Pub. 2002/072806, and not promoted as is the case in joints such as fingers.
  • To further strengthen the repair, the doctor may chose to reinforce the ligament/scaffolding matrix combination by attaching it to both bones and not just the bone from which the ligament detatched (e.g. also attach to the origin 217 in FIG. 15 above).
  • The scaffolding matrix M according to the invention may have various forms of fixation at its ends, such as bone plugs, anchors, or eyelets for screws.
  • Rotator Cuff Repair
  • Scaffolding matrix M may be used for major tendon/ligament tears, such as in the rotator cuff of the shoulder. Materials useful for this purpose are shown in FIGS. 16A-16D. These materials comprise a sheet of scaffolding matrix M attached on one (FIGS. 16A, B) or both (FIGS. 16C, D) of its ends with a bone block. The bone block will be made from a bone material which has been thoroughly processed so as to eliminate tissue typing and pathogenic disease issues. Methods of producing such bone material and attaching it to materials similar to scaffolding matrix M are disclosed in, for example, U.S. Pat. No. 4,597,766; U.S. Pat. No. 6,497,726; US Pub 2002/0072806; US Pub 2003/0023304; US Pub 2003/0097179; WO01/06933. Additionally, one or both of the bone blocks may have screw holes 210 drilled therethrough to provide for additional fixation of the bone block to its fixation point.
  • FIG. 17 shows an embodiment especially suitable for use in arthroscopic rotator cuff repairs. In this embodiment, scaffolding matrix M has a main portion and then splits towards its end into a number of fingers M′. Each finger M′ will have its own bone block 220, rather than one bone block span the entire width of scaffolding matrix M. This allows the entire scaffolding matrix/bone block construct to be rolled up and fed through an arthroscope canula.
  • FIGS. 18A-C depict different ways in which these various embodiments may be used in rotator cuff repair. In FIG. a8A, bone block 200 is seated within a groove made in the proximal humerus H. A press-fit connection may be used that is supplemented by screws 250. Scaffolding matrix M spans humeral head and is fixed to the scapula S via k-wires K. In FIG. 18C, there is also a bone block on the proximal end of scaffolding matrix M and that bone block is also attached to scapula S by K-wires K.
  • To those skilled in the art to which this invention relates, many changes in construction and widely different embodiments and applications of the subject process and device will suggest themselves without departing from the spirit and scope of the invention. The disclosures and descriptions herein are purely illustrative and are not intended to be in any sense limiting.

Claims (20)

1. A method for repairing a tendon in a patient, the tendon having ruptured into a first tendon portion having a first end portion and a second tendon portion having a second end portion, comprising:
providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,
accessing the tendon,
joining the first end portion to the second end portion by attaching said scaffolding matrix material to the first and the second tendon portions.
2. The method of claim 1, wherein said step of joining the first end portion to the second end portion is carried out by passing said scaffolding matrix material through the first end portion and the second end portion.
3. The method of claim 2, wherein said step of joining the first end portion to the second end portion further comprises supplementing said scaffolding material with a suture.
4. The method of claim 3, wherein said suture passes through said scaffolding matrix material to thereby assist in attaching said scaffolding matrix material to the first and the second tendons with a suture.
5. The method of claim 1, wherein the tendon is in a hand of the patient.
6. The method of claim 5, wherein the tendon is a flexor tendon of the hand, and said scaffolding matrix material is placed inside of said first and said second tendons, such that said scaffolding matrix material does not add bulk to the outside of the tendon so as not to inhibit movement of the tendon as the tendon moves through the hand.
7. The method of claim 1, wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.
8. The method of claim 1, wherein said scaffolding matrix material is from a human source.
9. The method of claim 1, wherein said scaffolding matrix material is from a non-human source.
10. The method of claim 9, wherein said non-human source is porcine.
11. The method of claim 1, wherein said scaffolding matrix material has a width of about 2 mm, a height of about 2 mm, and a length substantially greater than both said width and said height.
12. The method of claim 1, wherein said scaffolding matrix material has a width of about 3 mm, a height of about 2 mm, and a length substantially greater than both said width and said height.
13. A method for repairing a tendon in a patient, the tendon having ruptured into a first tendon portion having a first end portion and a second tendon portion having a second end portion, and in which the first and second end portions cannot be re-approximated due to a gap between the first and second end portions, comprising:
providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,
accessing the tendon,
attaching said scaffolding matrix material to the first end portion and to the second end portion such that said scaffolding matrix material spans the gap, thereby joining the first and second end portions together via said scaffolding matrix material, and
allowing new connective tissue from the patient to first repopulate and then build upon said scaffolding matrix material.
14. The method of claim 13, wherein said step of joining the first end portion to the second end portion further comprises supplementing said scaffolding material with a suture.
15. The method of claim 13, wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.
16. A method of repairing and augmenting a detached ligament in a joint of a patient, the ligament being naturally attached to a first bone of the joint but detached from a second bone of the joint, comprising:
providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,
accessing the joint,
attaching said scaffolding matrix material to the second bone portion from which the ligament has become detached; and
attaching said scaffolding matrix material along the ligament such that the ligament is augmented by said scaffolding matrix material and such that the first and second bones of the joint are attached to one another via said scaffolding matrix material and the ligament.
17. The method of claim 16, further comprising attaching said scaffolding matrix material to the first bone portion.
18. The method of claim 16, wherein said step of attaching said scaffolding matrix material to the ligament comprises placing said scaffolding matrix material parallel and next to the ligament and suturing said scaffolding matrix material to the ligament.
19. The method of claim 16, wherein the joint is in a finger or a thumb of the patient.
20. The method of claim 16, wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.
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Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100179591A1 (en) * 2009-01-13 2010-07-15 Saltzman Charles L Patch augmentation of achilles tendon repairs
US20120179254A1 (en) * 2011-01-10 2012-07-12 Saliman Justin D Implant and method for repair of the anterior cruciate ligament
US8562631B2 (en) 2009-11-09 2013-10-22 Ceterix Orthopaedics, Inc. Devices, systems and methods for meniscus repair
US8663253B2 (en) 2007-07-03 2014-03-04 Ceterix Orthopaedics, Inc. Methods of meniscus repair
US8702731B2 (en) 2007-07-03 2014-04-22 Ceterix Orthopaedics, Inc. Suturing and repairing tissue using in vivo suture loading
US8821518B2 (en) 2007-11-05 2014-09-02 Ceterix Orthopaedics, Inc. Suture passing instrument and method
US8911456B2 (en) 2007-07-03 2014-12-16 Ceterix Orthopaedics, Inc. Methods and devices for preventing tissue bridging while suturing
US9011454B2 (en) 2009-11-09 2015-04-21 Ceterix Orthopaedics, Inc. Suture passer with radiused upper jaw
US9211119B2 (en) 2007-07-03 2015-12-15 Ceterix Orthopaedics, Inc. Suture passers and methods of passing suture
US9247935B2 (en) 2013-09-23 2016-02-02 Ceterix Orthopaedics, Inc. Arthroscopic knot pusher and suture cutter
US9247934B2 (en) 2011-05-06 2016-02-02 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US9314234B2 (en) 2007-07-03 2016-04-19 Ceterix Orthopaedics, Inc. Pre-tied surgical knots for use with suture passers
US9492162B2 (en) 2013-12-16 2016-11-15 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices and methods
US9700299B2 (en) 2011-05-06 2017-07-11 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US9848868B2 (en) 2011-01-10 2017-12-26 Ceterix Orthopaedics, Inc. Suture methods for forming locking loops stitches
US9913638B2 (en) 2011-01-10 2018-03-13 Ceterix Orthopaedics, Inc. Transosteal anchoring methods for tissue repair
US10226245B2 (en) 2015-07-21 2019-03-12 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices that prevent entanglement
US10405853B2 (en) 2015-10-02 2019-09-10 Ceterix Orthpaedics, Inc. Knot tying accessory
US10441273B2 (en) 2007-07-03 2019-10-15 Ceterix Orthopaedics, Inc. Pre-tied surgical knots for use with suture passers
US10524778B2 (en) 2011-09-28 2020-01-07 Ceterix Orthopaedics Suture passers adapted for use in constrained regions
US10537321B2 (en) 2014-04-08 2020-01-21 Ceterix Orthopaedics, Inc. Suture passers adapted for use in constrained regions
US10675016B2 (en) 2015-10-30 2020-06-09 New York Society For The Relief Of The Ruptured And Crippled, Maintaining The Hospital For Special Surgery Suture sleeve patch and methods of delivery within an existing arthroscopic workflow
US10702260B2 (en) 2016-02-01 2020-07-07 Medos International Sàrl Soft tissue fixation repair methods using tissue augmentation scaffolds
US11484401B2 (en) 2016-02-01 2022-11-01 Medos International Sarl Tissue augmentation scaffolds for use in soft tissue fixation repair
US11744575B2 (en) 2009-11-09 2023-09-05 Ceterix Orthopaedics, Inc. Suture passer devices and methods

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9271766B2 (en) * 2004-10-26 2016-03-01 P Tech, Llc Devices and methods for stabilizing tissue and implants
US20060089646A1 (en) 2004-10-26 2006-04-27 Bonutti Peter M Devices and methods for stabilizing tissue and implants
US20080188936A1 (en) * 2007-02-02 2008-08-07 Tornier, Inc. System and method for repairing tendons and ligaments
US20100211174A1 (en) * 2009-02-19 2010-08-19 Tyco Healthcare Group Lp Method For Repairing A Rotator Cuff
US11547551B2 (en) 2016-03-02 2023-01-10 The Regents Of The University Of Michigan Engineered tendon graft for rotator cuff repair

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3345306A (en) * 1964-02-12 1967-10-03 Ethicon Inc Tubing fluid containing an amino acid
US4400833A (en) * 1981-06-10 1983-08-30 Kurland Kenneth Z Means and method of implanting bioprosthetics
US5445833A (en) * 1991-09-24 1995-08-29 Purdue Research Foundation Tendon or ligament graft for promoting autogenous tissue growth
US5855619A (en) * 1994-06-06 1999-01-05 Case Western Reserve University Biomatrix for soft tissue regeneration
US6102947A (en) * 1995-07-20 2000-08-15 Gordon; Leonard Splint with flexible body for repair of tendons or ligaments and method
US20030021850A1 (en) * 2001-06-28 2003-01-30 Rongxiang Xu Physiological tissue repair and functional organ regeneration by cultivation of regenerative stem cells in vivo and in situ

Family Cites Families (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5258040A (en) 1982-09-10 1993-11-02 W. L. Gore & Associates Prosthesis for tensile load-carrying tissue and method of manufacture
US5024830A (en) * 1983-08-23 1991-06-18 The Board Of Regents, The University Of Texas Method for cryopreparing biological tissue for ultrastructural analysis
US4865871A (en) * 1983-08-23 1989-09-12 Board Of Regents The University Of Texas System Method for cryopreparing biological tissue
US4597766A (en) 1984-10-26 1986-07-01 American Hospital Supply Corporation Implantable bioprosthetic tendons and ligaments
US4759765A (en) * 1986-03-17 1988-07-26 Minnesota Mining And Manufacturing Company Tissue augmentation device
GB8622563D0 (en) 1986-09-19 1986-10-22 Amis A A Artificial ligaments
US4755183A (en) 1987-02-09 1988-07-05 Pfizer Hospital Products Group, Inc. Ligament prosthesis
US4772288A (en) 1987-06-15 1988-09-20 Borner William H Method for producing implantable ligament and tendon prostheses and prostheses produced thereby
US5078744A (en) 1987-09-04 1992-01-07 Bio-Products, Inc. Method of using tendon/ligament substitutes composed of long, parallel, non-antigenic tendon/ligament fibers
US5061283A (en) 1987-10-30 1991-10-29 Pfizer Hospital Products Group, Inc. Method for tendon and ligament repair
FR2638349B1 (en) 1988-10-28 1990-12-28 Breard Francis PROSTHESIS OF TENDON AND PARTICULARLY SHOULDER HEAD
JP2881939B2 (en) * 1990-04-06 1999-04-12 住友電気工業株式会社 Surgical suture and method of manufacturing the same
US5336616A (en) * 1990-09-12 1994-08-09 Lifecell Corporation Method for processing and preserving collagen-based tissues for transplantation
US5860978A (en) * 1990-09-25 1999-01-19 Innovasive Devices, Inc. Methods and apparatus for preventing migration of sutures through transosseous tunnels
ATE131373T1 (en) 1991-05-24 1995-12-15 Synthes Ag ABSORBABLE TENDON AND BONE REINFORCEMENT DEVICE
FR2690073B1 (en) 1992-04-15 1994-11-18 Deux C T Repair prosthesis for the rotator cuff of the shoulder.
GB2282328B (en) 1993-09-29 1997-10-08 Johnson & Johnson Medical Absorbable structures for ligament and tendon repair
US6106556A (en) 1994-12-02 2000-08-22 Omeros Medical Systems, Inc. Tendon and ligament repair system
CN1229083C (en) * 1994-12-02 2005-11-30 奥默罗斯公司 Tendon and ligament repair system
US5723008A (en) 1995-07-20 1998-03-03 Gordon; Leonard Splint for repair of tendons or ligaments and method
US5702422A (en) * 1995-12-06 1997-12-30 Stone; Kevin R. Anterior cruciate ligament repair method
FR2748652B1 (en) 1996-05-15 1998-07-24 Fontes Didier PROTHETIC LIGAMENT OF THE SHOULDER
US6083244A (en) 1996-09-13 2000-07-04 Tendon Technology, Ltd. Apparatus and method for tendon or ligament repair
US6984241B2 (en) * 1996-09-13 2006-01-10 Tendon Technology, Ltd. Apparatus and methods for tendon or ligament repair
AU738044B2 (en) 1996-11-21 2001-09-06 Ethicon Inc. Apparatus and methods for anchoring autologous or artificial tendon grafts in bone
US6497726B1 (en) 2000-01-11 2002-12-24 Regeneration Technologies, Inc. Materials and methods for improved bone tendon bone transplantation
WO2000051662A1 (en) 1999-03-04 2000-09-08 Tepha, Inc. Bioabsorbable, biocompatible polymers for tissue engineering
DE60036863T2 (en) 1999-03-25 2008-07-31 Metabolix, Inc., Cambridge Medical devices and uses of polyhydroxyalkanoate polymers
WO2001006933A2 (en) 1999-07-26 2001-02-01 Regeneration Technologies, Inc. Suture anchor
EP1221909B1 (en) 1999-10-18 2007-03-07 Tendon Technology, Ltd. Apparatus for tendon or ligament repair
US6740100B2 (en) 1999-12-23 2004-05-25 Omeros Corporation Tendon repair using adhesive
US6524317B1 (en) * 1999-12-30 2003-02-25 Opus Medical, Inc. Method and apparatus for attaching connective tissues to bone using a knotless suture anchoring device
US6893462B2 (en) 2000-01-11 2005-05-17 Regeneration Technologies, Inc. Soft and calcified tissue implants
US20030023304A1 (en) 2000-01-11 2003-01-30 Carter Kevin C. Materials and methods for improved bone tendon bone transplantation
US20030097179A1 (en) 2000-01-11 2003-05-22 Carter Kevin C. Materials and methods for improved bone tendon bone transplantation
US6712830B2 (en) 2000-03-15 2004-03-30 Esplin Medical Inventions, L.L.C. Soft tissue anchor
US20020133229A1 (en) 2000-03-24 2002-09-19 Laurencin Cato T. Ligament and tendon replacement constructs and methods for production and use thereof
US6485503B2 (en) * 2000-05-19 2002-11-26 Coapt Systems, Inc. Multi-point tissue tension distribution device, a brow and face lift variation, and a method of tissue approximation using the device
US6533821B1 (en) 2000-06-22 2003-03-18 Thomas Lally Bio-adhesive composition, method for adhering objects to bone
FR2810877B1 (en) 2000-07-03 2002-09-13 Vincent Travers SHOULDER PROSTHETIC LIGAMENT IMPLANT
US8366787B2 (en) 2000-08-04 2013-02-05 Depuy Products, Inc. Hybrid biologic-synthetic bioabsorbable scaffolds
US6638312B2 (en) 2000-08-04 2003-10-28 Depuy Orthopaedics, Inc. Reinforced small intestinal submucosa (SIS)
CA2777791A1 (en) 2000-09-18 2002-03-21 Organogenesis Inc. Methods for treating a patient using a bioengineered flat sheet graft prostheses
US6852330B2 (en) * 2000-12-21 2005-02-08 Depuy Mitek, Inc. Reinforced foam implants with enhanced integrity for soft tissue repair and regeneration
US20030181889A1 (en) 2002-03-21 2003-09-25 Little Adrian Leigh Healing accelerator
GB0210517D0 (en) 2002-05-03 2002-06-19 Giltech Ltd Material
US20030212456A1 (en) 2002-05-09 2003-11-13 John Lipchitz Implant for tissue repair
US7824701B2 (en) 2002-10-18 2010-11-02 Ethicon, Inc. Biocompatible scaffold for ligament or tendon repair
US20050043805A1 (en) * 2003-08-11 2005-02-24 Chudik Steven C. Devices and methods used for shoulder replacement
EP1971290A2 (en) * 2006-01-12 2008-09-24 Histogenics Corporation Method for repair and reconstruction of ruptured ligaments or tendons and for treatment of ligament and tendon injuries
US8016883B2 (en) * 2006-02-07 2011-09-13 Tepha, Inc. Methods and devices for rotator cuff repair

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3345306A (en) * 1964-02-12 1967-10-03 Ethicon Inc Tubing fluid containing an amino acid
US4400833A (en) * 1981-06-10 1983-08-30 Kurland Kenneth Z Means and method of implanting bioprosthetics
US5445833A (en) * 1991-09-24 1995-08-29 Purdue Research Foundation Tendon or ligament graft for promoting autogenous tissue growth
US5855619A (en) * 1994-06-06 1999-01-05 Case Western Reserve University Biomatrix for soft tissue regeneration
US6102947A (en) * 1995-07-20 2000-08-15 Gordon; Leonard Splint with flexible body for repair of tendons or ligaments and method
US20030021850A1 (en) * 2001-06-28 2003-01-30 Rongxiang Xu Physiological tissue repair and functional organ regeneration by cultivation of regenerative stem cells in vivo and in situ

Cited By (48)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8920441B2 (en) 2007-07-03 2014-12-30 Ceterix Orthopaedics, Inc. Methods of meniscus repair
US8911456B2 (en) 2007-07-03 2014-12-16 Ceterix Orthopaedics, Inc. Methods and devices for preventing tissue bridging while suturing
US9211119B2 (en) 2007-07-03 2015-12-15 Ceterix Orthopaedics, Inc. Suture passers and methods of passing suture
US10441273B2 (en) 2007-07-03 2019-10-15 Ceterix Orthopaedics, Inc. Pre-tied surgical knots for use with suture passers
US8702731B2 (en) 2007-07-03 2014-04-22 Ceterix Orthopaedics, Inc. Suturing and repairing tissue using in vivo suture loading
US9314234B2 (en) 2007-07-03 2016-04-19 Ceterix Orthopaedics, Inc. Pre-tied surgical knots for use with suture passers
US8663253B2 (en) 2007-07-03 2014-03-04 Ceterix Orthopaedics, Inc. Methods of meniscus repair
US8821518B2 (en) 2007-11-05 2014-09-02 Ceterix Orthopaedics, Inc. Suture passing instrument and method
US20100179591A1 (en) * 2009-01-13 2010-07-15 Saltzman Charles L Patch augmentation of achilles tendon repairs
US8808299B2 (en) 2009-11-09 2014-08-19 Ceterix Orthopaedics, Inc. Devices, systems and methods for meniscus repair
US8562631B2 (en) 2009-11-09 2013-10-22 Ceterix Orthopaedics, Inc. Devices, systems and methods for meniscus repair
US11744575B2 (en) 2009-11-09 2023-09-05 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US9011454B2 (en) 2009-11-09 2015-04-21 Ceterix Orthopaedics, Inc. Suture passer with radiused upper jaw
US10004492B2 (en) 2009-11-09 2018-06-26 Ceterix Orthopaedics, Inc. Suture passer with radiused upper jaw
US8500809B2 (en) * 2011-01-10 2013-08-06 Ceterix Orthopaedics, Inc. Implant and method for repair of the anterior cruciate ligament
US8888848B2 (en) 2011-01-10 2014-11-18 Ceterix Orthopaedics, Inc. Implant and method for repair of the anterior cruciate ligament
US10987095B2 (en) 2011-01-10 2021-04-27 Ceterix Orthopaedics, Inc. Suture methods for forming locking loops stitches
US20120179254A1 (en) * 2011-01-10 2012-07-12 Saliman Justin D Implant and method for repair of the anterior cruciate ligament
US10561410B2 (en) 2011-01-10 2020-02-18 Ceterix Orthopaedics, Inc. Transosteal anchoring methods for tissue repair
US9913638B2 (en) 2011-01-10 2018-03-13 Ceterix Orthopaedics, Inc. Transosteal anchoring methods for tissue repair
US9848868B2 (en) 2011-01-10 2017-12-26 Ceterix Orthopaedics, Inc. Suture methods for forming locking loops stitches
US10188382B2 (en) 2011-05-06 2019-01-29 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US9861354B2 (en) 2011-05-06 2018-01-09 Ceterix Orthopaedics, Inc. Meniscus repair
US9247934B2 (en) 2011-05-06 2016-02-02 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US9700299B2 (en) 2011-05-06 2017-07-11 Ceterix Orthopaedics, Inc. Suture passer devices and methods
US10758222B2 (en) 2011-05-06 2020-09-01 Ceterix Orthopaedics, Inc. Meniscus repair
US10524778B2 (en) 2011-09-28 2020-01-07 Ceterix Orthopaedics Suture passers adapted for use in constrained regions
US10820899B2 (en) 2013-09-23 2020-11-03 Ceterix Orthopaedics, Inc. Arthroscopic knot pusher and suture cutter
US9332980B2 (en) 2013-09-23 2016-05-10 Ceterix Orthopaedics, Inc. Arthroscopic knot pusher and suture cutter
US9247935B2 (en) 2013-09-23 2016-02-02 Ceterix Orthopaedics, Inc. Arthroscopic knot pusher and suture cutter
US10143464B2 (en) 2013-09-23 2018-12-04 Ceterix Orthopaedics, Inc. Arthroscopic knot pusher and suture cutter
US10524779B2 (en) 2013-12-16 2020-01-07 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices and methods
US9492162B2 (en) 2013-12-16 2016-11-15 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices and methods
US10537321B2 (en) 2014-04-08 2020-01-21 Ceterix Orthopaedics, Inc. Suture passers adapted for use in constrained regions
US10226245B2 (en) 2015-07-21 2019-03-12 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices that prevent entanglement
US10806442B2 (en) 2015-07-21 2020-10-20 Ceterix Orthopaedics, Inc. Automatically reloading suture passer devices that prevent entanglement
US10405853B2 (en) 2015-10-02 2019-09-10 Ceterix Orthpaedics, Inc. Knot tying accessory
US10675016B2 (en) 2015-10-30 2020-06-09 New York Society For The Relief Of The Ruptured And Crippled, Maintaining The Hospital For Special Surgery Suture sleeve patch and methods of delivery within an existing arthroscopic workflow
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US11937803B2 (en) 2016-02-01 2024-03-26 Medos International Sarl Soft tissue fixation repair methods using tissue augmentation constructs
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