WO2012159018A1 - Ensemble implant méniscal et procédé associé - Google Patents
Ensemble implant méniscal et procédé associé Download PDFInfo
- Publication number
- WO2012159018A1 WO2012159018A1 PCT/US2012/038548 US2012038548W WO2012159018A1 WO 2012159018 A1 WO2012159018 A1 WO 2012159018A1 US 2012038548 W US2012038548 W US 2012038548W WO 2012159018 A1 WO2012159018 A1 WO 2012159018A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- assembly
- scaffold material
- meniscus
- peripheral rim
- stretch material
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/38—Joints for elbows or knees
- A61F2/3872—Meniscus for implantation between the natural bone surfaces
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30014—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30019—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
Definitions
- the present invention relates generally to an assembly and method for use in repairing or replacing a damaged meniscus in a patient during arthroscopic surgery.
- the meniscus is a fibrocartilaginous structure in the knee joint which performs multiple critical functions, including contributing to normal knee biomechanics and the general well-being of the joint.
- the menisci are comprised of two C- shaped fibrocartilaginous structures residing on the tibial plateau.
- the peripheral rim of a meniscus is thick, tapering to a thin, free inner border.
- the superior surface is contact with the femoral condyles, while the inferior surface is in contact with the tibial plateau.
- the collagen fibers within the menisci are mainly oriented circumferentially throughout the meniscus, parallel to the peripheral border, to withstand hoop stresses placed upon the meniscus by the femoral condyles. Menisci may be torn by twisting injuries to the knee and the extent of the tear is variable.
- the peripheral region or zone of the meniscus is generally referred to as the red zone that has good blood supply. This is usually the peripheral 1 ⁇ 2 of the meniscus.
- the inner region or zone of the meniscus (the remaining 3 ⁇ 4) is generally referred to as the white zone and is avascular. Nutrition for this zone is drawn from the joint fluid
- the assembly of the present invention is suitable for patients who have lost their whole meniscus out to the peripheral rim and provides hoop-stress resistance.
- the present invention will reduce the expense and morbidity associated with waiting for and undergoing meniscal transplantation.
- An assembly for repairing or replacing a damaged meniscus of the knee comprising: a) a scaffold material substantially in the shape of a meniscus having a thick peripheral rim area tappering of to a thin inner border, b) a sleeve intimately connected to the scaffold material along the length of the thick peripheral rim, and c) a rectangular non-stretch material inside the length of the sleeve and extending outward at both ends of the sleeve, wherein the assembly provides support to retain at least the meniscal function of hoop-stress resistance.
- the assembly may also provide a mechanism for anchorage of the meniscal substitute to the bone.
- An assembly for repairing or replacing a damaged meniscus of the knee comprising: a) a scaffold material substantially in the shape of a meniscus having a thick peripheral rim area tappering of to a thin inner border, and b) a rectangular non- stretch material attached to the scaffold material along the entire length of the thick peripheral rim and extending in the same direction past the peripheral rim on both longitudinal edges, wherein the assembly provides support and retains at least the meniscal function of hoop-stress resistance.
- the assembly may also provide a mechanism for anchorage of the meniscal substitute to the bone.
- the scaffold material may be a porous structure such as for example comprising natural or synthetic fibers in a fabric or non- woven film material, or comprising polymer foam material.
- This scaffold material is preferably biocompatible and/or degradable.
- the scaffold material comprises a biocompatible and degradable polymer foam.
- the non-stretch material may be a natural or synthetic ligament, or any other biocompatible fiber or braided and/or woven structure.
- This natural ligament can be a tendon, such as a single hamstring tendon or the synthetic ligament can be any biocompatible ligament structure such as for example a polyester ligament.
- the ligament is attached to the scaffold material in such a manner so as to ensure that the ligament-scaffold material assembly remains porous to blood supply and cell ingrowth.
- a method for repairing or replacing a damaged meniscus of the knee includes forming a passage in the knee to repair the tear or lesion, the passage defining an entrance and an exit. The assembly of the present invention is passed through the passage.
- the assembly is manipulated whereby the implant assembly is positioned so as to replace the damaged meniscus and providing all meniscal functions including hoop- stress resistance and cushioning of the joint surfaces.
- the assembly can then secured to the knee joint, preferably the tibia, using a securing means.
- Figure 1 Shows a schematic side view of a meniscus repair/replacement assembly
- a scaffold material implant comprising a scaffold material implant, a sleeve at the peripherial rim of the scaffold material, and a non-stretch material inside the sleeve.
- Figure 2 Shows a schematic top view of a meniscus repair/replacement assembly
- a scaffold material implant comprising a scaffold material implant, a sleeve at the peripheral rim of the scaffold material, and a non-stretch material inside the sleeve.
- Figure 3 Shows a schematic side view of a meniscus repair/replacement assembly
- FIG. 4 Shows a schematic top view of a meniscus repair/replacement assembly according to the present invention comprising a scaffold material implant, a sleeve at the peripheral rim of the scaffold material, and a non-stretch material attached directly to the peripheral rim of the scaffold material by means of a suture.
- Figure 5 Shows a perspective view of a meniscus repair/replacement assembly
- a non-stretch material that extends beyond the longitudinal ends of the peripheral rim of the scaffold material.
- Figure 6 Shows a perspective view of a meniscus repair/replacement assembly
- Figure 7 Shows a back view of a meniscus repair/replacement assembly according to the present invention showing direct attachment of a non-stretch material to the peripheral rim of the scaffold material by means of a suture.
- a technique may be used wherein a scaffold material is implanted in order to replace the damage or lost meniscus.
- This process of meniscus reconstruction requires removal of remaining meniscal tissue to provide space for an implant of scaffold material including a non-stretch material attached to the peripheral rim thereof.
- the implant of scaffold material may need to be shaped to match the missing meniscus, either as a whole or as a portion.
- This shaped implant of scaffold material is then implanted in the knee joint to replace the meniscus. Improvements in tissue engineering and surgical techniques with minimal tissue damage and reduced pain associated with tissue repair, aimed at preserving meniscal function may provide significant benefits in the potential healing response of meniscal tears.
- the assembly and method of the present invention provides for meniscus repair/replacement while providing full meniscal functionality including maintenance of the hoop-stress resistance to protect the joint surfaces of the femur and tibia in the knee joint.
- the assembly comprises a scaffold material in the shape of a meniscus 1 having a thick peripheral rim area 10, tapering of to a thin inner border 11.
- a top face of the scaffold material 2 provides support for a condyle of the femur while a bottom area 3 is to be situated on top of the tibial plateau.
- a sleeve 4 is connected to the scaffold material.
- a rectangular non-stretch material 5 is inside the sleeve and provides support for the meniscal implant assembly to maintain hoop-stress resistance.
- the non-stretch material preferably extends beyond both ends of the sleeve 4. These extended ends of the rectangular non- stretch material 5 may be used as a means to secure the assembly implant into the knee joint for example on top of the tibial plateau.
- the assembly may be attached to the tibial plateau by way of securing the extended ends of the non-stretch material through a hole in the bone that has been drilled, or by fixing with suture anchor devices.
- the sleeve 4 may be part of the scaffold material and be formed by way of tunnel boring a sleeve in the peripheral rim 10 of the scaffold material. Alternatively the sleeve may be connected to the peripheral rim of the through a connection means such as, for example, a suture.
- the scaffold material 1 provides a matrix which allows re-growth of the meniscal tissue in the scaffold material 1. Further, the sleeve 4 and non-stretch material 5 may be attached to the scaffold material so as to ensure that the structure remains porous to blood supply and cell ingrowth.
- the composition of the scaffold material 1 can be any porous scaffold material such as for example comprising natural or synthetic fibers in a fabric or non-woven material, or comprising polymer foam material.
- This scaffold material is preferably biocompatible and/or degradable.
- the scaffold material comprises a biocompatible foam that is degradable.
- the assembly according to the present invention comprises a scaffold material in the shape of a meniscus 1 having a thick peripheral rim area 10, tapering of to a thin inner border 11.
- a top face of the scaffold material 2 provides support for a condyle of the femur joint while a bottom area 3 is to be situated on top of the tibial plateau.
- a rectangular non- stretch material 5 is attached to the peripheral rim of the scaffold material 1.
- the rectangular non-stretch material may be connected to the peripheral rim 10 of the scaffold material 2 through a means to attach the non-stretch material to the peripheral rim 10 such as, for example, one or more sutures 8.
- the scaffold material 1 provides a matrix which allows re-growth of the meniscal tissue in the scaffold material 1.
- non-stretch material 5 may be attached to the scaffold material so as to ensure that the structure remains porous to blood supply.
- the rectangular non-stretch material 5 can extend beyond the longitudinal edge of the peripheral rim 10 in an extended section 7.
- the extended section 7 of the non-stretch material 5 can be used to secure the implant assembly of the present invention to the knee joint, for example on the tibial plateau.
- the assembly may be attached to the tibial plateau by way of securing the extended ends 7 of the non-stretch material 5 through a hole in the bone that has been drilled, for example tunnel bored.
- the non-stretch material 5, or the extended ends 7 thereof may further comprise another means of securing the assembly 6 to the knee joint for example by use of sutures.
- Figure 5 shows a perspective view of such an assembly according to the invention comprising a scaffold material 1 and a non-stretch material 5 attached to the entire length of the peripheral rim 10 and further extending beyond the edges of the peripheral rim into an extended portion 7 which may comprise a securing means for attaching the assembly to the knee joint.
- the non-stretch material 5 is attached to the scaffold material 1 by means of one or more sutures 8.
- Figures 6 and 7 show a top perspective view and a back view of such attachment of the non-stretch material 5 to the scaffold material 1 by means of one or more sutures 8.
- the composition of the scaffold material that is used for the scaffold material implant of the assembly according to the invention can be any porous scaffold material such as for example comprising natural or synthetic fibers in a fabric or non-woven material, or comprising polymer foam material. Additionally, the scaffold material may further comprise additional growth promoting materials such as for example blood clot, bone marrow, platelet rich plasma (PRP), and growth factors.
- the scaffold material is preferably biocompatible and/or degradable. Preferably the scaffold material comprises a biocompatible polymer foam that is degradable.
- Such foams for use in the assembly according to the present invention have properties especially useful for such assembly, including having a modulus of compression between about 50 kPa to about 1500 kPa, preferably about 250 kPa to about 400 kPa, a tear strength of greater than or equal to about 3 N/mm, and flexibility (strain at break) of about 100 % or higher.
- These advantageous properties are in part due to the high molecular weight of the polymers in the foam and in part due to the interconnectivity of the polymers in the foam. This high molecular weight and interconnectivity are achieved by the process of making the polyurethane polymer and by the process of making the foam from the polyurethane polymer as described for example in International Patent Application No.
- the final average molecular weight of the polymer in the foam is preferably about 1 10 kg/mol to about 240 kg/mol. More preferably the average molecular weight of the polymer is about 120 kg/mol to about 240 kg/mol. Even more preferably, the average molecular weight of the polymer in the foam is 140 kg/mol to about 240 kg/mol.
- the polymer in such foam my be a polyurethane prepared by a process comprising the steps of: (a) reacting a diol, preferably a Ci-Cio alkyl diol, more preferably 1 ,4-butanediol, with an oxygen containing compound that can form a macrodiol by ring-opening polymerization, preferably a lactone, more preferably ⁇ - caprolactone, to provide a macrodiol, wherein the reaction is carried out to completion, preferably until the unreacted remaining oxygen containing compound that can form a macrodiol by ring-opening polymerization is less than 0.5% by mole equivalents of the total amount of the oxygen containing compound, more preferably less than about 0.2% by mole equivalents; (b) treating the macrodiol with a diisocyanate, to obtain a macrodiisocyanate, wherein the unreacted diisocyanate is removed under a pressure of less than about 0.
- a biocompatible foam that is degradable as may be used in the assembly according to the present invention may be prepared from such polyurethane by for example a process comprising: (a) preparing a solution of about 20%> to about 50%> (w/v), preferably of about 30%> to about 45% (w/v), preferably about 36% (w/v) of polyurethane in an appropriate solvent, preferably wherein the polyurethane is soluble, preferably DMSO, DMF, chloroform, 1 ,4-dioxane, NMP, m-cresol, dimethyl acetamide, more preferably DMSO; (b) combining the solution with a non-solvent, preferably water or a Ci-C 6 alkyl diol, more preferably water, to obtain a solution, preferably the amount of non-solvent added to the solution is in an amount from 5% to 30% (v/v), more preferably 5%) to 20%), most preferably from 5% to 10%> (v/v); (c
- the non-stretch material may be a natural or synthetic ligament, or any other biocompatible fiber or braided and/or woven structure.
- a natural ligament can be a tendon, such as a single hamstring tendon.
- a synthetic ligament can be any
- the non-stretch material is attached to the scaffold material in such a manner so as to ensure that the non-stretch material-scaffold material assembly remains porous to blood supply.
- the non-stretch material-scaffold material assembly of the present invention is prepared from materials and shaped in such a form so as not to irritate any local tissues of the patient.
- the current invention provides a novel approach to total meniscal reconstruction while maintaining meniscal function including hoop-stress resistance by providing an assembly for repairing or replacing a damaged meniscus of the knee comprising a scaffold material substantially in the shape of a meniscus having a thick peripheral rim area tapering of to a thin inner border, and a rectangular non-stretch material attached to the scaffold material along the entire length of the thick peripheral rim and extending in the same direction past the peripheral rim on both longitudinal edges thereof, either directly secured to the scaffold material or passed through a sleeve attached to the entire length of the peripheral rim of the scaffold material.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
La présente invention concerne un ensemble destiné à réparer ou à remplacer un ménisque endommagé chez un patient, l'ensemble comprenant un matériau de support. L'invention concerne également des procédés d'utilisation d'un tel ensemble pour réparer et maintenir la fonction du ménisque.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161487450P | 2011-05-18 | 2011-05-18 | |
| US61/487,450 | 2011-05-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2012159018A1 true WO2012159018A1 (fr) | 2012-11-22 |
Family
ID=46178827
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2012/038548 Ceased WO2012159018A1 (fr) | 2011-05-18 | 2012-05-18 | Ensemble implant méniscal et procédé associé |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2012159018A1 (fr) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3200728A4 (fr) * | 2014-10-02 | 2018-06-13 | McCullen, Seth | Dispositifs implantables dans le ménisque de conception anatomique |
| WO2018066921A3 (fr) * | 2016-10-06 | 2018-08-09 | 아주대학교 산학협력단 | Dispositif pour supporter une contrainte d'arceau de cartilage semi-lunaire |
| WO2018204440A3 (fr) * | 2017-05-02 | 2019-01-17 | Mccullen Seth | Implant articulaire composite |
| US10449053B2 (en) | 2012-10-02 | 2019-10-22 | Seth McCullen | Implantable devices for musculoskeletal repair and regeneration |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0372811A1 (fr) * | 1988-12-02 | 1990-06-13 | Stryker Corporation | Implant |
| DE29615920U1 (de) * | 1996-09-12 | 1998-01-15 | Waldemar Link GmbH & Co, 22339 Hamburg | Gelenkendoprothese |
| US20020022884A1 (en) * | 2000-03-27 | 2002-02-21 | Mansmann Kevin A. | Meniscus-type implant with hydrogel surface reinforced by three-dimensional mesh |
| US20090259314A1 (en) * | 2008-04-09 | 2009-10-15 | Active Implants Corporation | Meniscus prosthetic device selection and implantation methods |
| WO2009141732A2 (fr) | 2008-05-19 | 2009-11-26 | Orteq B.V. | Mousse de polyuréthane destinée à être utilisée dans des implants médicaux |
| WO2011106369A1 (fr) * | 2010-02-25 | 2011-09-01 | Orteq B.V. | Ensemble et procédé de réparation d'un ménisque |
| WO2012019248A1 (fr) * | 2010-08-12 | 2012-02-16 | Intigo Giselle Nominees Pty Ltd | Prothèses de ménisque et leur procédé d'implantation dans l'articulation du genou chez l'être humain |
-
2012
- 2012-05-18 WO PCT/US2012/038548 patent/WO2012159018A1/fr not_active Ceased
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0372811A1 (fr) * | 1988-12-02 | 1990-06-13 | Stryker Corporation | Implant |
| DE29615920U1 (de) * | 1996-09-12 | 1998-01-15 | Waldemar Link GmbH & Co, 22339 Hamburg | Gelenkendoprothese |
| US20020022884A1 (en) * | 2000-03-27 | 2002-02-21 | Mansmann Kevin A. | Meniscus-type implant with hydrogel surface reinforced by three-dimensional mesh |
| US20090259314A1 (en) * | 2008-04-09 | 2009-10-15 | Active Implants Corporation | Meniscus prosthetic device selection and implantation methods |
| WO2009141732A2 (fr) | 2008-05-19 | 2009-11-26 | Orteq B.V. | Mousse de polyuréthane destinée à être utilisée dans des implants médicaux |
| WO2011106369A1 (fr) * | 2010-02-25 | 2011-09-01 | Orteq B.V. | Ensemble et procédé de réparation d'un ménisque |
| WO2012019248A1 (fr) * | 2010-08-12 | 2012-02-16 | Intigo Giselle Nominees Pty Ltd | Prothèses de ménisque et leur procédé d'implantation dans l'articulation du genou chez l'être humain |
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10449053B2 (en) | 2012-10-02 | 2019-10-22 | Seth McCullen | Implantable devices for musculoskeletal repair and regeneration |
| US11382758B2 (en) | 2012-10-02 | 2022-07-12 | Seth McCullen | Implantable devices for musculoskeletal repair and regeneration |
| EP3200728A4 (fr) * | 2014-10-02 | 2018-06-13 | McCullen, Seth | Dispositifs implantables dans le ménisque de conception anatomique |
| US10034755B2 (en) | 2014-10-02 | 2018-07-31 | Seth McCullen | Anatomically designed meniscus implantable devices |
| EP3613386A1 (fr) * | 2014-10-02 | 2020-02-26 | McCullen, Seth | Dispositifs implantables dans le ménisque conçus anatomiquement |
| US10743998B2 (en) | 2014-10-02 | 2020-08-18 | Seth McCullen | Anatomically designed meniscus implantable devices |
| US11890199B2 (en) | 2014-10-02 | 2024-02-06 | Orthonika Limited | Anatomically designed meniscus implantable devices |
| WO2018066921A3 (fr) * | 2016-10-06 | 2018-08-09 | 아주대학교 산학협력단 | Dispositif pour supporter une contrainte d'arceau de cartilage semi-lunaire |
| US11000383B2 (en) | 2016-10-06 | 2021-05-11 | Ajou University Industry-Academic Cooperation Foundation | Device for supporting hoop stress of meniscus |
| WO2018204440A3 (fr) * | 2017-05-02 | 2019-01-17 | Mccullen Seth | Implant articulaire composite |
| US11452606B2 (en) | 2017-05-02 | 2022-09-27 | Orthonika Limited | Composite joint implant |
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