WO2008120215A2 - Implant intra articulaire pour traiter des irrégularités dans des surfaces de cartilage - Google Patents

Implant intra articulaire pour traiter des irrégularités dans des surfaces de cartilage Download PDF

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Publication number
WO2008120215A2
WO2008120215A2 PCT/IL2008/000456 IL2008000456W WO2008120215A2 WO 2008120215 A2 WO2008120215 A2 WO 2008120215A2 IL 2008000456 W IL2008000456 W IL 2008000456W WO 2008120215 A2 WO2008120215 A2 WO 2008120215A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
joint
cartilage
surgical implant
joint space
Prior art date
Application number
PCT/IL2008/000456
Other languages
English (en)
Other versions
WO2008120215A3 (fr
Inventor
Hamid Sharim
Shmuel Beck
Original Assignee
Novocart Medical Solutions Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Novocart Medical Solutions Ltd filed Critical Novocart Medical Solutions Ltd
Publication of WO2008120215A2 publication Critical patent/WO2008120215A2/fr
Publication of WO2008120215A3 publication Critical patent/WO2008120215A3/fr

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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
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    • 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
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    • 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
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    • 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
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A61F2007/0056—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water for cooling
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • A61F2007/0076—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled remote from the spot to be heated or cooled
    • A—HUMAN NECESSITIES
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0019—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/06—Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction

Definitions

  • the invention relates to methods and apparatus for promoting regeneration of cartilage.
  • Cartilage due to its physiological characteristics has minimal ability to repair itself.
  • the forces that are exerted on the cartilage inhibit healing even further.
  • even small damages in the cartilage, if remain untreated, can hinder a subject's ability to move without pain, and cause deterioration to the joint surface.
  • the first level includes a superficial damage to the cartilage and generally does not require any treatment.
  • the second level includes a deeper damage to the cartilage, which is often accompanied with pain.
  • the third and fourth levels include massive degradation of the cartilage and in severe cases even a partial or complete exposure of the bone. Patients suffering from these levels of damage experience significant pain and mobility reduction.
  • Injuries such as fracture(s), damage to the cartilage itself, the tendon(s), ligament(s) and/or meniscus), reoccurring injuries, for example in athletes;
  • OA osteoarthritis
  • OA is a condition, often occurring in elderly people, in which low-grade inflammation results in degradation (wearing) of the cartilage that covers and acts as a cushion inside joints, such as knees, hips, elbows and other joints).
  • the degradation of the cartilage leads to pain in the joints.
  • Inflammation of the surrounding joint capsule complete envelopes surrounding the joint
  • New bone outgrowths called “spurs” or osteophytes, can form on the margins of the joints, possibly in an attempt to improve the congruence of the articular cartilage surfaces.
  • These bone changes, together with the inflammation, can be both painful and debilitating.
  • OA patients experience pain particularly upon weight bearing, including walking and standing. Due to decreased movement because of the pain, regional muscles may atrophy, and ligaments may become more lax.
  • NSAIDs Non-Steroidal Anti-Inflammatory Drugs
  • physiotherapy Treatment is often applied in mild cases of a second level of cartilage damage.
  • steroid agents such as glucocorticoid and/or hyaluronic agent, for example, synvisc or hyaluronan.
  • This treatment which may be used in any level of cartilage damage, allows only temporary pain relief and some suppression of the friction within the joint.
  • Arthroscopy which is a surgical procedure in which a small fiberoptic telescope (arthroscope) is inserted into a joint, while the surgeon can view the procedure on a monitor.
  • the surgeon can, for example, remove or repair of a torn meniscus or cartilage, reconstruct ligament(s), remove loose debris, and trim damaged cartilage.
  • Other treatment that may be performed during arthroscopy includes shaping the damaged part of the cartilage and allowing a new connective tissue (such as a scar tissue) to grow and replace the missing part of the cartilage.
  • Arthroscopic treatments are generally performed in severe cases of a second level of cartilage damage and also in third or fourth levels of cartilage damage.
  • Arthroscopy is less traumatic to the joint tissues, such as the cartilage, muscles and ligaments, than the traditional method of open surgery of the joint.
  • the benefits of arthroscopy involve smaller incisions, faster healing, a more rapid recovery, and less scarring.
  • the results obtained by the existing arthroscopic methods are partial and often only temporary, particularly in more progressed stages of cartilage damage (levels 3-4), in which the success rates are very low (typically as low as 3-4%). More information about arthroscopy may be found at http://www.arthritis.org/conditions/surgerycenter/surgerycenterflash/arthroscopy.html, which is herein incorporated by reference, in its entirety.
  • Severe cases of joint conditions may be treated with irreversible and invasive procedures such as joint replacement surgery.
  • This procedure which includes an opening of the joint, has a limited success chance and in a case of failure must be performed over and over again until satisfying results are obtained.
  • ACI Autologous Chondrocyte Implantation
  • ACI includes harvesting chondrocyte (cartilage generating cells) from a patient's joint, typically a knee, and culturing and multiplying them. The fresh chondrocytes are then reimplanted in the patient's joint and cause hyaline cartilage to regenerate. This procedure may be performed using arthroscopic methods. More information about arthroscopy may be found at http://www.scoi.com/carticel.htm, which is herein incorporated by reference, in its entirety. The success rates of ACI are not yet known.
  • carrier refers to a type of dense connective tissue composed of collagenous fibers and/or elastic fibers, and cells called chondrocytes, all of which are embedded in a firm gel-like ground substance called the matrix.
  • Cartilage is avascular (contains no blood vessels) and nutrients are diffused through the matrix.
  • cartilage refers to any kind of cartilage, for example, articular (hyaline) cartilage (which is most prominently found in diarthroidal joints covering long bones, such as the femur and the tibia which connect at the knee) fibrocartilage (which is most permanently present in the intervertebral disks of the spine, as a covering of the mandibular condyle in the temporomandibular joint, and in the meniscus of the knee), and elastic cartilage (which naturally exists in the epiglottis and the eustachian tube). More information about the structure and function of cartilage may be found at http://www.chelationtherapyonline.com/articles/pl79.htm, which is incorporated herein by reference in its entirety.
  • diarthroidal joint(s) refers to the most common and most moveable type of joints in the body. As with all other joints in the body, synovial joints achieve movement at the point of contact of the articulating bones. Structural and functional differences distinguish the synovial joints from the two other types of joints in the body, with the main structural difference being the existence of a cavity (a joint cavity, such as a knee cavity) between the articulating bones and the occupation of a fluid in that cavity which aids movement. More information about diarthroidal joints may be found at http://en.wikipedia.org/wiki/SynovialJoint, which is incorporated herein by reference in its entirety.
  • joint(s) refers to the location at which two or more bones are functionally connected. Joints are constructed to allow movement and provide mechanical support, and may be classified structurally and functionally. More information about joints may be found at http://en.wikipedia.org/wiki/Joint, which is incorporated herein by reference in its entirety.
  • CDS-I Cell Density Signal-1
  • Amgen Inc. is planning to use genetic engineering to bring CDS-I into mass production.
  • Prolotherapy represents a less invasive alternative to surgery. It is a form of treatment that stimulates the repair of injured or damaged structures. It involves the injection of dextrose or natural glycerin at the exact site of an injury to stimulate the immune system to repair the area.
  • prolotherapy causes an inflammatory reaction at the exact site of injuries to such structures as ligaments, tendons, menisci, muscles, growth plates, joint capsules, and cartilage to stimulate these structures to heal.
  • prolotherapy causes fibroblasts to multiply rapidly. Fibroblasts are the cells that actually make up ligaments and tendons. The rapid production of new fibroblasts means that strong, fresh collagen tissue is formed, which is what is needed to repair injuries to ligaments or tendons.
  • An aspect of some embodiments of the invention relates to providing methods and apparatus for promoting regeneration of cartilage.
  • cartilage regeneration is promoted by reducing stress on the cartilage, optionally, while enabling a patient to engage in substantially normal activity.
  • cartilage degradation is inhibited by reducing stress on the cartilage, optionally, while enabling a patient to engage in substantially normal activity.
  • An aspect of some embodiments of the invention relates to providing an implant for use in the treatment of damaged cartilage within a joint.
  • the implant is adapted to be inserted into a cavity of the joint and reduce stress on the cartilage engendered, for example, by patient activity.
  • the implant may form an internal cushion, which protects the cartilage such that wearing forces (such as pressure, friction, squeezing, stretching, bending, sliding, twisting, pulling and other forces) on the cartilage are reduced.
  • wearing forces such as pressure, friction, squeezing, stretching, bending, sliding, twisting, pulling and other forces
  • a method of promoting cartilage regeneration includes inserting an implant which includes a padding material in a joint of interest.
  • the method may further include shaping and/or inflating the implant, for example by inserting fluid to the implant. Shaping and/or inflating the implant may be applied, for example, in order to induce a desired cushioning effect.
  • the method may further include deflating the implant, for example, by extracting the fluid from the implant.
  • the cartilage is articular cartilage, such as knee cartilage.
  • the implant is adapted to impose a shaping force upon the cartilage.
  • the implant has a surface that contacts the damaged cartilage and is adapted to facilitate cartilage regeneration.
  • at least a portion of the implant's contact surface promotes the formation of a substantially smooth cartilage surface.
  • at least a portion of the implant's contact surface promotes the formation of a substantially rough cartilage surface.
  • the implant for example, the implant's surface, may include a medicament adapted to promote cartilage healing and/or to inhibit cartilage degradation.
  • medicaments may include for example, NSAIDs (Nonsteroidal Anti-Inflammatory Drugs), steroid agents such as glucocorticoid and/or hyaluronic agent, for example, synvisc or hyaluronan.
  • NSAIDs Nonsteroidal Anti-Inflammatory Drugs
  • steroid agents such as glucocorticoid and/or hyaluronic agent, for example, synvisc or hyaluronan.
  • the medicament may be adapted for immediate release or sustained release, for example, embedded within a matrix, such as a polymeric matrix.
  • the implant may be a temporary implant.
  • the temporary implant may be removed from the joint after a certain period of time, for example upon achieving a certain result, such as sufficient tissue reconstruction.
  • the implant may at least partially undergo degradation or dissolve in the body.
  • the implant may include a balloon adapted to be inserted into a joint and to be inflated with fluid after insertion.
  • the inflated balloon is adapted to assume a shape that occupies at least a portion of the joint cavity and thus protects the cartilage and impede the damaged cartilage reconstruction.
  • the fluid may be extracted and optionally, the balloon may be removed from the joint.
  • the implant may include a gel-like material, such as silicone gel, optionally encapsulated within another material, such as a silicone shell.
  • a gel-like material such as silicone gel
  • the (optionally encapsulated) gel-like material is adapted to be inserted into a joint, for example by a needle, and to occupy at least a portion of the joint cavity.
  • the (optionally encapsulated) gel-like material may form a padding layer, optionally having a flat shape (or rough). This padding layer protects the cartilage from wearing forces that may impede the damaged cartilage reconstruction.
  • the implant may be anchored to the joint in order to minimize undesired migration within the joint.
  • Anchoring may be performed, for example, by sewing a portion of the implant to a soft tissue in proximity to or within the joint.
  • the aforementioned the surgical implant is adapted to repair an intraarticular fracture.
  • the aforementioned articular fracture is selected from a group consisting of knee fracture, ankle fracture, elbow fracture, shoulder fracture, foot fracture, wrist fracture or hand fracture.
  • devices and methods are adapted for repairing damaged nerves
  • cartilage regeneration or “cartilage reconstruction” refer to any process that includes the formation of a new cartilage tissue and/or any other tissue, for example, connective tissue and/or a scar tissue, substantially in or proximate to a location normally occupied by cartilage.
  • Figs. IA and IB schematically show a knee in extension (A) and in flexion (B), in accordance with an embodiment of the invention
  • Fig. 2 schematically shows a partial view of a longitudinal cross section of a knee in extension, in accordance with an embodiment of the invention
  • FIG. 3A schematically shows a partial view of a longitudinal cross section of a knee in extension, receiving an implant, in accordance with an embodiment of the invention
  • Fig. 3B schematically shows a partial view of a longitudinal cross section of a knee in extension, receiving an implant, in accordance with an embodiment of the invention
  • Fig. 3C schematically shows a partial view of a longitudinal cross section of a knee in extension, receiving an implant, in accordance with an embodiment of the invention.
  • Fig. 4 schematically shows optional implants, in accordance with an embodiment of the invention.
  • Fig. 5 schematically shows an embodiment of the invention.
  • Fig 5a schematically shows another embodiment of the invention
  • Fig. 6 schematically shows an embodiment of the invention
  • Fig. 7 schematically shows a detail of an embodiment of the invention
  • Fig. 7a schematically shows a detail of an embodiment of the invention
  • Fig 8 schematically shows an embodiment of the invention
  • Fig 9 schematically shows an embodiment of the invention DETAILED DESCRIPTION OF EMBODIMENTS
  • Figs. IA and IB schematically show a knee 100 in extension (Fig. IA) and a knee 102 in flexion (Fig. IB), in accordance with an embodiment of the invention.
  • the knee 100 is essentially made up of four bones: the femur 104, the tibia 106, the fibula 108 and the patella 110.
  • the femur 104 which is the large bone in the thigh, attaches by ligaments and a capsule to the tibia 106.
  • the fibula 108 Just below and next to the tibia is the fibula 108, which runs parallel to the tibia 106.
  • the patella 110 also called the kneecap, rides on the knee joint as the knee bends (Fig. IB).
  • the articular cartilage 112 and the meniscus 114 are cartilaginous elements within the knee joint serve to protect the ends of the bones from rubbing on each other and to effectively deepen the tibia 106 sockets into which the femur 104 attaches.
  • the ACL (anterior cruciate ligament) 116 is connected to the tibia 106 on one end and to the femur 104 on the other end and prevents the tibia 106 from being pushed too far anterior relative to the femur 104.
  • the LCL (lateral collateral ligament) 118 is connected to the fibula 108 on one end and to the femur 104 on the other end and protects the lateral side from an inside bending force.
  • the patellar tendon (ligament) 120 is connected to the pattela 110 on one end and to the tibia 106. The patellar tendon (ligament) 120 helps give the patella 110 its mechanical leverage.
  • Fig. 2 schematically shows a partial view of a longitudinal cross section of a knee 200 in extension, in accordance with an embodiment of the invention.
  • Three bones are shown in the knee 200: the femur 202, the tibia 204 and the fibula 206.
  • Also shown are the articular cartilage 212 of the femur 202, the articular cartilage 208 of the tibia 204 and the knee capsule 210.
  • the articular cartilage 212 has a damaged section 214 and the articular cartilage 208 has a damaged section 216.
  • the damaged section 214 of the articular cartilage 212 and the damaged section 216 of the articular cartilage 208 are shown to be located in the medial compartment part of the knee 200, but may occur in any other section of the articular cartilage 208 and/or 216, independently.
  • the damaged section 214 of the articular cartilage 212 and the damaged section 216 of the articular cartilage 208 may be a result of any number of factors such as those described herein, for example, injuries (such as fracture(s), damage to the cartilage itself, the tendon(s), ligament(s) and/or meniscus), reoccurring injuries, post trauma conditions and joint diseases, such as osteoarthritis (OA).
  • injuries such as fracture(s), damage to the cartilage itself, the tendon(s), ligament(s) and/or meniscus
  • reoccurring injuries such as fracture(s), damage to the cartilage itself, the tendon(s), ligament(s) and/or meniscus
  • reoccurring injuries such as fracture(s
  • a knee cavity 218 is schematically shown between the femur 202 and the tibia 204.
  • Figs. 3A-3C schematically show different stages of a knee 300 in extension (partial view of a longitudinal cross section), receiving an implant 316, in accordance with an embodiment of the invention.
  • Three bones are shown in the knee 300: the femur 302, the tibia 304 and the fibula 306.
  • Also shown are the articular cartilage 312 of the femur 302, the articular cartilage 308 of the tibia 304 and the knee capsule 310.
  • the articular cartilage 312 has a damaged section 314 and the articular cartilage 308 has a damaged section 316.
  • the damaged section 314 of the articular cartilage 312 and the damaged section 316 of the articular cartilage 308 are shown to be located in the medial compartment part of the knee 300, but may occur in any other section of the articular cartilage 308 and/or 316, independently.
  • the damaged section 314 of the articular cartilage 212 and the damaged section 216 of the articular cartilage 208 may be a result of any number of factors such as those described herein.
  • a knee cavity 318 is schematically shown between the femur 302 and the tibia 304.
  • An implant 319 is being inserted into the knee cavity 318 in proximity to damaged section 314 and damaged section 316. In Fig.
  • the implant 319 is shown in deflated state, in other words, containing substantially no fluid or containing only a partial amount of fluid.
  • the implant 319 may be a balloon, which may be comprised of silicone or any other appropriate material or combination of materials such as polyurethane and it's derivatives, silicone rubber and it's derivatives or a modified biological material such as a proteoglycan reduced soft tissue xenograph.
  • the implant 319 includes an inflation tube 324 adapted for filling the implant 319 with fluid (not shown).
  • the fluid may include a low viscosity fluid, such as water, saline, hyaluronic acid, air carbon Dioxide or any other appropriate fluid.
  • the implant 319 and the inflation tube 324 as shown in Fig.
  • the insertion tube 322 may be for example, a needle a catheter, an injector, such as manual or automatic injector or any other appropriate means capable of inserting an implant, such as implant 319.
  • the implant 319 is being positioned in the knee cavity 318 and the insertion tube 322 is being gradually or rapidly removed.
  • the implant 319 is being inflated with fluid.
  • the inflation with fluid can be performed during the removal of the insertion tube 322.
  • the inflation with fluid can also be performed (or continued) after at least a part of the insertion tube 322 has been removed.
  • the procedure of inserting an implant as disclosed herein, such as implant 319 may be a part of an arthroscopic procedure that can be performed under local or general anesthesia.
  • the insertion tube 322 may thus be a part of arthroscopic equipment.
  • the inflation tube may include a sealed port adapted for inserting and/or extracting fluid to or from the implant 319.
  • a port or tap which may be a part of the inflation tube 324 but may also be another part functionally associated with the implant, such as implant 319).
  • the port can also be used for extraction of fluid from the implant 319, for example prior to the extraction of the implant 319 from the knee. Fluid can also be inserted and/or extracted from the implant 319 in order to reshape the implant 319 and thus apply the desired shaping force on the damaged cartilage, such as damaged section 314 and damaged section 316.
  • the port may be comprised of a flexible material, such as rubber or silicone, which can be re-sealed after the insertion of a needle for inserting and/or extracting fluid.
  • the inflation tube 324 which may or may not include a port, can also be used for anchoring the implant 319 to the joint in order to minimize undesired migration within the joint and to allow accessible insertion and/or extraction of fluid.
  • Anchoring may be performed, for example, by sewing a portion of the implant to a soft tissue in proximity to or within the joint and/or the joint capsule 310.
  • any implant as disclosed herein, such as implant 319 may include more than one inflation tubes 324 and/or one or more anchoring elements for anchoring the implant, such as implant 319, to more than on location such as the knee capsule 310.
  • the implant as refered to herein may also comprise a gel-like material and/or semi-fluid material (in addition to or instead of a balloon), such as silicone gel, optionally encapsulated within another material, such as a silicone shell.
  • a gel-like material and/or semi-fluid material in addition to or instead of a balloon
  • silicone gel optionally encapsulated within another material, such as a silicone shell.
  • the (optionally encapsulated) gel-like implant can be inserted into a joint such as the knee 300, as described in Figs. 3A-3C, for example by an insertion tube (such as the insertion tube 322 as described in Figs. 3A-3C) and to occupy at least a portion of the joint cavity (such as the knee cavity 318 as described in Figs. 3A-3C).
  • the (optionally encapsulated) gel-like implant may form an optionally flat, padding layer, which protects the cartilage from wearing forces that may impede the damaged cartilage reconstruction.
  • the gel-like implant for example silicone gel implant, which may optionally be encapsulated within another material, such as a silicone shell may have one or more anchoring elements adapted to anchor the implant in the joint, such as a knee and prevent its migration.
  • the anchoring elements may be similar in structure to the inflating tube 324 of implant 319 described herein.
  • the implant, such as implant 319 or any other appropriate implant, for example, the implants as disclosed herein may be a permanent or temporary implant which is used as a padding material adapted to pad the cartilage such that wearing forces are reduced on the cartilage.
  • the implant which includes a padding material, is adapted to protect the cartilage during the process of healing, repairing and/or regenerating.
  • the implant such as implant 319 or any other appropriate implant may, for example, the implants as disclosed herein, may be adapted to impose a shaping force upon the cartilage.
  • the implant may further be adapted to impose a substantially smooth surface on the cartilage reconstructing. Since the implant, which includes a padding material, is designed to "wrap" the cartilage, when the cartilage heals, repairs and/or regenerates, the newly formed tissue (such a connective tissue) may assume the shape, such as a smooth shape, of the implant.
  • the implant can be removed from the joint.
  • the temporary implant may also be removed from the joined after a certain result (such as sufficient tissue reconstruction and/or pain relief) was obtained or whenever the physician finds it appropriate.
  • damaged cartilage sections in the medial section of the joint, which is a common situation, for example in OA (osteoarthritis).
  • the damaged cartilage sections may be in any other part of the joint, for example, in the lateral part of the joint.
  • the implant may be positioned in the appropriate place according to the damaged section.
  • Fig. 4 schematically shows optional implants, in accordance with an embodiment of the invention.
  • Figs. 4A, 4B and 4C show different shapes of deflated implants (balloon type implants or gel- like implants) 400, 402 and 404 respectively, in accordance with an embodiment of the invention.
  • Figs. 4A ⁇ 4B' and 4C show implants 400, 402 and 404 in the inflated form
  • the deflated implants are marked 400', 402' and 404' respectively, in accordance with an embodiment of the invention.
  • the deflated implants 400', 402' and 404' are packed within insertion tubes 401, 403 and 405 respectively.
  • Figs. 4A and 4A' show implants 400 and 400' having no anchoring elements and/or inflation tubes.
  • Figs. 4B and 4B' show implants 402 and 402', having one anchoring element and/or inflation tube 404 and 404' respectively.
  • Figs. 4C and AC show implants 406 and 406', each having two anchoring elements and/or inflation tubes 408, 410 and 408', 410', respectively.
  • figs 5 and 5a schematically shows optional embodiments of an implant with anchoring tabs for securing the implant to soft tissue in or near the joint space.
  • the hatched are represents the inner portion adapted to accommodate an infill
  • the unhatched outer area represents the outer envelope portion.
  • the relative sizes of the outer portion and the inner portion vary according to the specific requirements of any specific embodiment.
  • the inner portion may be infilled or not according to specific requirements of a particular embodiment of the invention.
  • the inner portion may be solid, semi solid or hollow according to the specific requirements of a particular embodiment of the invention.
  • other shapes or forms of implants are also possible and are not limited by any of the drawings.
  • the inner concept of the invention is an inflatable implant for temporary implantation into a patient knee which provides both shock absorbance and reshaping of the diseased or injured joint.
  • a removable implant adapted for short term residence in the knee, which can be filled with slow release therapeutic agents is further disclosed herein.
  • embodiments of the invention are further disclosed wherein the regeneration of type II cartilage in a damaged synovial joint is stimulated.
  • the aforementioned regeneration may be promoted by the release of narcotics, medicaments, hormones and local anti inflammatory drugs.
  • the anti inflammatory drugs may be NSAID's or corticosteroids.
  • the aforementioned regeneration may also be promoted by the massaging and smoothing effect of the aformentinoed surgical implant as the bones of the joint move, possibly stimulating relocation and reseeding of healthy chondrocytes on areas of the synovial capsule which have been excessively worn.
  • Regeneration may also be envisaged as being stimulated by controlled abrasion provided by controlled release of abrasive materials selected from a group consisting of diamond dust, aluminium oxide powders, salts, minerals, all said same diluted or suspended in mineral oil or solvents. The materials are released into the synovial joint from the implant at predetermined rates, quantities and intervals.
  • the implant will have a somewhat raised texture, in the form for example of treads, bumps, indentations, nipples and the like, in order to provide reshaping effects on the synovial surfaces .
  • fig 5 is a schematic representation of an embodiment of a temporary surgical implant for a damaged synovial joint, especially the knee joint, useful for insertion into the synovial space of said joint.
  • the implant provides separation between bones of the joint, softened mechanical contact and reshaping of the joint and regeneration of cartilage.
  • the implant comprises an infilled member wherein the member comprises
  • the envelope is characterized in that the envelope portion comprises a thermoplastic elastomer of a hardness between about 30 and about 60 Shore A and the inner portion is characterized in that the inner portion comprises a thermoplastic elastomer of a hardness between about 3 Shore A and about 15 Shore A, the infill comprising pressure maintaining fluid.
  • FIG. 5 and 5a illustrating schematically a further embodiment of the invention wherein the surgical implant as described above is provided with anchoring means (510) for fixation within the synovial joint.
  • the envelope thickness may vary in different embodiments of the invention.
  • the thickness under compression is greater than about 1 mm and less than the thickness of the implant not under compression.
  • the envelope is adapted to be separately implanted into said synovial joint.
  • the implant is further provided with an opening for post implantation introduction and withdrawal of inner portion or infill.
  • the aforementioned implant further comprises at least one additional layer portion(620) disposed between the envelope portion (610) and the inner portion (630), further wherein the envelope further comprises a series of apertures for sustained release of medicines into the synovial joint.
  • the envelope apertures are uni-directional valves (730), (750) adapted to facilitate controlled efflux of medicine (740) and preventing influx of synovial fluid.
  • the layer (710) may be the medical substance bearing additional layer or alternatively, the inner core which may, in some embodiments release medicine via the outer envelope.
  • the medicines are at least one selected from a group consisting of narcotics, medicaments, hormones and local anti inflammatory drugs.
  • the anti inflammatory drugs may be NSAID's or corticosteroids.
  • the envelope is porous or permeable and further wherein the inner portion or infill is adapted for storage and release of abrasive materials useful for reshaping synovial joint surfaces, the abrasive materials selected from a group consisting of diamond dust, aluminium oxide powders, salts, minerals, same diluted or suspended in mineral oil or solvents, such that the materials are released into the synovial joint at predetermined rates, quantities and intervals.
  • abrasive materials selected from a group consisting of diamond dust, aluminium oxide powders, salts, minerals, same diluted or suspended in mineral oil or solvents, such that the materials are released into the synovial joint at predetermined rates, quantities and intervals.
  • Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application. (Williams, 1999) reference is now made to embodiments of the invention which may, at least in part, comprise biocompatible materials falling within any of the three following definitions:
  • biocompatibility is defined as the absence of host response and does not include any desired or positive interactions between the host tissue and the biomaterials. Comparison of the tissue response produced through the close association of the implanted candidate material to its implant site within the host animal to that tissue response recognized and established as suitable with control materials- ASTM
  • biocompatibility of a long-term implantable medical device refers to the ability of the device to perform its intended function, with the desired degree of incorporation in the host, without eliciting any undesirable local or systemic effects in that host
  • biocompatibility of a medical device that is intentionally placed within the cardiovascular system for transient diagnostic or therapeutic purposes refers to the ability of the device to carry out its intended function within flowing blood, with minimal interaction between device and blood that adversely affects device performance, and without inducing uncontrolled activation of cellular or plasma protein cascades.
  • Biocompatibility of tissue-engineering products refers to the ability to perform as a substrate that will support the appropriate cellular activity, including the facilitation of molecular and mechanical signaling systems, in order to optimize tissue regeneration, without eliciting any undesirable effects in those cells, or inducing any undesirable local or systemic responses in the eventual host.
  • a biocompatible material (sometimes shortened to biomaterial) is a synthetic or natural material used to replace part of a living system or to function in intimate contact with living tissue.
  • Biocompatible materials are intended to interface with biological systems to evaluate, treat, augment or replace any tissue, organ or function of the body. Biomaterials are usually non-viable, but may also be viable.
  • a biocompatible material is different from a biological material such as bone that is produced by a biological system.
  • Artificial hips, vascular stents, artificial pacemakers, and catheters are all made from different biomaterials and comprise different medical devices.
  • Biomimetic materials are not made by living organisms but have compositions and properties similar to those made by living organisms.
  • the calcium hydroxylapatite coating found on many artificial hips is used as a bone replacement that allows for easier attachment of the implant to the living bone.
  • Surface functionalization may provide a way to transform a bio-inert material into a biomimetic or even bioactive material by coupling of protein layers to the surface, or coating the surface with self-assembling peptide scaffolds to lend bioactivity and/or cell attachment 3-D matrix.
  • Plasma processing has been successfully applied to chemically inert materials like polymers or silicon to graft various functional groups to the surface of the implant.
  • Polyanhydrides are polymers successfully used as a drug delivery materials.
  • AVI's Biomimetic Coating was designed by polymer scientists at the University of Utah and clinical immunologists at Uppsala University.
  • the surface coating is inspired by the body's natural healing mechanisms and the immune system's ability to recognize "self from "non-self.
  • the design incorporates elements that prevent the inflammatory processes that lead to restenosis, while still providing a favorable surface for healing and regeneration of the endothelium.
  • AVI's coronary stent coating has two parts. One part is a proprietary End Group Activated Polymer (EGAP).
  • EGAP surface technology transforms traditional device materials into biocompatible and thromboresistant surfaces and further enables the attachment of biologically active or therapeutic compounds.
  • the second part of the coating is a protein called factor H, which interrupts the inflammatory processes that lead to restenosis.
  • stent implantation Factors that lead to restenosis are introduced at the time of stent implantation when the endothelial lining and smooth muscle cells (SMC) in the artery wall are damaged.
  • SMC smooth muscle cells
  • thrombus formation and complement activation both of which cause activation of inflammatory cells.
  • Activated inflammatory cells fuel the restenosis process by migrating into the artery wall and secreting mitogens. These in turn stimulate SMC growth and matrix production, which are the primary contributors to narrowing of the arterial lumen.
  • restenosis post angioplasty is due largely to elastic recoil with only a small contribution from neointima proliferation.
  • EGAP is a triblock copolymer that self assembles on surfaces and forms a thick brush-like layer of polyethylene oxide that acts as a protective shield to prevent protein adsorption, platelet activation, and thrombus formation. Based on proprietary end group activation chemistry, EGAP acts as a linker for binding factor H to the stent surface and allows for a high level of control over the amount of protein loaded onto the stent.
  • Factor H is an important protein that regulates complement activation. This regulation occurs by multiple mechanisms which include disruption of C3 convertase formation and acceleration of its decay. Factor H also acts as a cofactor to factor I in the degradation of C3b, and competes with factor B for binding to C3b. Factor H can be produced recombinantly or isolated from human plasma by conventional fractionation techniques. With AVF s proprietary coating technology, factor H is covalently linked to stents through the activated end groups of the EGAP coating.
  • AVI's coating is different from current drug eluting stents (DES).
  • DES target the outcome of inflammation by preventing cell growth and migration.
  • Cell growth and migration are important processes that are required for healing of the endothelium.
  • a major advantage of AVI's Biomimetic coating is that it targets inflammation at an early stage, which does not impair healing.
  • Polymer component is biocompatible and thromboresistant
  • Coating is securely bound to stent and does not crack, peel or form webs that may interfere with side branch flow with stent expansion
  • Aqueous based coating process is environmentally friendly
  • the EGAP - Factor H coating has demonstrated efficacy in preventing inflammation after implantation of stents, it is an object of the invention to provide implants coated with EGAP and EGAP like polymers linked to Factor H or Factor H like products.
  • implants coated with EGAP linked to Factor H will have an anti - inflammatory effect on the joint, joint space and cartilage surfaces. It is well within the scope of the invention to provide embodiments of the implant coated with EGAP linked to Factor H to alleviate damaged joints. It is further well within the scope of the invention to provide implants releasing EGAP linked to Factor H compounds in a controlled and sustained manner into the joint space.
  • Gold salts describe ionic chemical compounds of gold.
  • the term which is a misnomer, has evolved into a euphemism for the gold compounds used in medicine.
  • the application of gold compounds to medicine is called “chrysotherapy” and "aurotherapy.”[l]
  • the first reports of research in this area appeared in 1935,[2] primarily to reduce inflammation and to slow disease progression in patients with rheumatoid arthritis.
  • Most chemical compounds of gold, including some of the drugs discussed below, are not in fact salts. Indications
  • Gold compounds which accumulate slowly in the body and, over time, reduce inflammation, especially related to rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, membranous nephritis, lupus erythematosus and, infrequently, juvenile rheumatoid arthritis (JRA).
  • JRA juvenile rheumatoid arthritis
  • Gold drugs can be administered orally or by intramuscular injection, in which case it is administered weekly for approximately three to five months before less-frequent doses begin.
  • Auranofin, in capsule form for oral administration is marketed under the brand name Ridaura.
  • Sodium aurothiomalate Gold sodium thiomalate as brands Myocrisin UK, Aurolateor or Myochrysine U.S.
  • aurothioglucose Solganal in U.S.
  • Orally administered gold has fewer side effects than intramuscular injections.
  • Common side effects of oral gold include decreased appetite, nausea, hair thinning and diarrhea, as well as problems affecting skin, blood, kidneys, or lungs.
  • Common side effects of injected gold include an itchy skin rash or mouth sores, with rare instances of kidney problems or suppression of blood cell production.
  • Aurothioglucose is a gold salt used in treating inflammatory arthritis.
  • gold salts can decrease the inflammation of the joint lining. This effect can prevent destruction of bone and cartilage.
  • embodiments of the invention include a surgical implant such that the implant further comprises at least one additional layer portion disposed between the envelope portion and the inner portion, further wherein the envelope further comprises a series of apertures for sustained release of medicines into said joint space.
  • the aforementioned medicines may comprise at least one selected from a group consisting of narcotics, medicaments, hormones, local anti inflammatory drugs, gold salts and salts other than gold salts.
  • the aforementioned gold salts may comprise at least one selected from a group consisting of Auranofin ,Aurothioglucose ,GoId thioglucose ,Disodium aurothiomalate ,Sodium aurothiosulfate ,GoId sodium thiosulfate, Sodium aurothiomalate, Gold sodium thiomalate Aurothioglucose and Solganal
  • NIR Near-infrared
  • NIRS Near infrared spectroscopy
  • Pharmaceutical, medical diagnostics including blood sugar and oximetry are among it's applications. It is commonly used for medical diagnostics, in particular for oximetry (the measurement of oxygen levels in the blood) and for blood sugar determination.
  • some embodiments of the implant will include means for carrying, housing and /or accommodating a NIRS probe within the joint space for monitoring processes occurring within the joint space environment.
  • Arthroscopy is a highly sensitive method of evaluating high-grade cartilage lesions but the detection of low-grade lesions is often is unreliable. Objective measurements are required.
  • NIRS near-infrared-spectroscopy
  • the mean ratio of 2 NIR absorption bands of intact cartilage 3.8 (range 2.3 to 8.7).was significantly lower than that of cartilage with grade 1 lesions (12.8, range 4.8 to 19.6) and grade 2 lesions (13.4, range 10.4 to 15.4).
  • NIRS can be used to distinguish between ICRS grade 1 lesions and healthy cartilage during arthroscopic surgeries.
  • the results of this clinical study demonstrate the potential of NIRS to objectify classical arthroscopic grading systems.
  • NIR Near-infrared
  • Arthroscopy is a highly sensitive method of evaluating high-grade cartilage lesions but the detection of low-grade lesions is often is unreliable. Objective measurements are required.
  • NIRS near-infrared-spectroscopy
  • the mean ratio of 2 NIR absorption bands of intact cartilage 3.8 (range 2.3 to 8.7).was significantly lower than that of cartilage with grade 1 lesions (12.8, range 4.8 to 19.6) and grade 2 lesions (13.4, range 10.4 to 15.4).
  • NIRS can be used to distinguish between ICRS grade 1 lesions and healthy cartilage during arthroscopic surgeries.
  • the results of this clinical study demonstrate the potential of NIRS to objectify classical arthroscopic grading systems.
  • Cartilage degeneration is associated with complex changes in cartilage matrix composition that result in decreased collagen and proteoglycan content and increased water content. These changes in matrix composition correlate with decreased mechanical stiffness. As a result, four stages of cartilage lesions develop.
  • MRI Magnetic resonance Imaging
  • dGEMRIC Delayed Gadolinium Enhanced MRI of Cartilage
  • the arthroscopic diagnosis of chondral lesions depends on the surgeon's subjective rating alone. Diagnosis is made by visualizing the lesion on the video monitor and by probing with the arthroscopy hook.
  • This study introduces a novel NIRS-device that is capable of identifying low-grade cartilage lesions under arthroscopic control.
  • the preoperative diagnosis was made by clinical examination, radiography and MRI. All patients had suffered from knee pain and demonstrated clinical signs of medial meniscus tears. No patient had radiological signs of osteoarthritis on standard x-ray [27].
  • the cartilage defects were graded by MRI according to Vallotton et al. [28]. No patient had abnormal MRI findings in the lateral compartment or within the femoropatellar joint. The evaluations of the radiographs and MRI scans were performed by author EK.
  • the arthroscopic evaluation began with visualization of all joint compartments and included palpation with an arthroscopic hook.
  • the cartilage defects were graded according to the ICRS protocol [1] by visualization and probing with an arthroscopic hook : ICRS grade 0 (normal), ICRS grade 1 (nearly normal, superficial lesions with soft indentation and/or superficial fissures and cracks), ICRS grade 2 (abnormal, lesions extending down to ⁇ 50% of cartilage depth.
  • the ICRS grade classifications were determined independently by author MK, whereas the NIR measurements were performed independently by GS. Both are experienced arthroscopic surgeons who have performed more than 10.000 knee arthroscopies.
  • NIRS for evaluation of cartilage lesions.
  • Light from a stabilized light source was coupled into six optical fibers.
  • the collection fiber (silica glass, 200 ⁇ m diameter) was connected to the spectrometer.
  • the fibers were combined in a reflection-probe with the light delivering fibers surrounding the collection fiber.
  • the design of the probe was similar to a routine arthroscopic hook.
  • the intraoperative measurements were performed by using the probe in the same way as a hook. The top of the hook shows the end of the optical fibers.
  • the main components of the NIR spectrometer system were a diode micro-spectrometer (microparts, Dortmund, Germany) with a spectral range of 1100 nm to 1700 nm and spectral resolution of approx 16 nm, a stabilized light source (LQ2NIR, JETI Technische Instrumente GmbH, Jena, Germany) and a fibre optical reflection probe (Loptec, Berlin, Germany) with six fibers (silica glass, 200 ⁇ m diameters) for illumination surrounding one collection fibre (silica glass, 200 ⁇ m diameter)[26].
  • the probe's design is similar to that of a hook used for routine arthroscopy.
  • the whole NIR spectrometer system (optical and electrical parts) is in accordance with the German law for medical products (Medical Device Directive (MDD) 93/42/EEC) [29].
  • This ratio (absorption at 1425 nm/absorption at 1175 nm) represents the relative proportion of water to organic substances and can therefore be regarded as an indicator of the water content within the cartilage [29]. Evaluation of NIR measurements was completed independently by author HP.
  • the cartilage lesions in a total of 48 regions were evaluated by MRI, arthroscopy and NIRS.
  • the arthroscopic diagnosis made by a "highly experienced" arthroscopic surgeon was defined as the diagnostic standard for the cartilage lesions.
  • the "normal-value [mean ⁇ 2 SD]" of R for intact cartilage was 1.4 to 6.2.
  • the 27 normal cartilages (grade 0) had values of R within the normal value excepting one outlier with a higher R.
  • the values of R were always higher for cartilage lesions than for intact cartilage.
  • the diagnosis of cartilage lesions can be made by MRI as well as arthroscopic evaluation. MRI using "routine sequences" has good validity for diagnosis of deep cartilage lesions. In contrast it is relatively inaccurate for evaluation of low grade lesions or validation of intact cartilage [28- 36].
  • NIRS offers the possibility of evaluating changes in material composition [25]. Since water has a particularly high NIR absorption, NIRS is able to analyze water content in composite materials.
  • NIRS is a completely nondestructive method. By using NIRS the surgeon can distinguish between healthy and low-grade cartilage lesions, but not between high-grade lesions. This may be due to the fact that a water inflow is characteristic of the initial phase of degeneration but not of more advanced stages of chondral disease.
  • cartilage lesions were graded by a highly-experienced arthroscopic surgeon (MK), these grades are still subjective and therefore stand as the principal point of critique in our study.
  • MK highly-experienced arthroscopic surgeon
  • NIRS evaluations were made independently from the standard cartilage grading. The high concordance between arthroscopic grading and NIRS may favor this technique for future use in arthroscopy.
  • StO 2 values were simultaneously recorded from the contralateral (uninjured) limb at the same site. The difference between the StO 2 value on the injured and uninjured sides was calculated (StO 2 difference). 2) Fifteen adult pigs were divided into three equal groups: plasma infusion alone, plasma infusion with SC hematoma (15 ml of blood) and whole blood infusion (intramuscular hematoma). An ACS was induced under general anesthesia by the above infusion into the anterior compartment of one rear leg of each animal. On both legs noninvasive StO 2 and compartment pressure monitoring were carried out. The development of an ACS was confirmed by absence of muscle twitch on electrical stimulation. Fasciotomy was performed 30 minutes later.
  • NIRS monitoring of the internal state of a joint space and of a synovial joint space The inner portion of the implant is provided with an internal NIRS sensor unit. This sensor receives power and or transmits data concerning the internal state of a joint space and of a synovial joint space via a tube extending from the implant outward to a subdermal location which can be opened when necessary for connecting to a power supply and or the data recording device or monitor.
  • a further means and method is provided for NIRS monitoring of the internal state of a joint space and of a synovial joint space.
  • the inner portion of the implant is provided with an internal NIRS sensor unit, which has its own internal or adjacent power supply and is further adapted to reside in the implanted implant, and monitor the surrounding tissue and cartilage from within the joint space.
  • the NIRS sensor unit can record data for subsequent study upon withdrawal from the implant and joint space via the communicating tube.
  • Other embodiments of the invention are envisaged wherein the NIRS sensor unit is provided with means for wirelessly transmitting data from within the joint space to an external monitor.
  • biocompatible and biodegradable materials which can be used to comprise at least part of the implant may be selected from the following non limiting list: Polylactic acid (PLA), Polyglycolic acid (PGA), Polycaprolactone (PCL) , Polydioxanone (PDO or PDS) PLGA or poly(lactic-co-glycolic acid) Polyhydroxybutyrate (PHB) Poly-3- hydroxybutyrate (P3HB)
  • PLGA is a combination of the cyclic dimers (l,4-dioxane-2,5-diones) of glycolic acid and lactic acid).
  • some embodiments of the invention may comprise at least in part of Nitinol or other shape -memory material.
  • some embodiments of the invention may comprise at least in part of Electo Active Materials.
  • the envelope is porous and further wherein the additional layer is adapted for storage and release of abrasive materials useful for reshaping synovial joint surfaces, the abrasive materials selected from a group consisting of diamond dust, aluminium oxide powders, salts, minerals, all said same diluted or suspended in mineral oil or solvents, such that said materials are released into the synovial joint at predetermined rates, quantities and intervals.
  • abrasive materials selected from a group consisting of diamond dust, aluminium oxide powders, salts, minerals, all said same diluted or suspended in mineral oil or solvents, such that said materials are released into the synovial joint at predetermined rates, quantities and intervals.
  • any of the portions of the infilled member comprise radio-opaque material useful for positioning the implant or monitoring the health status of the joint.
  • the infill is selected from a group consisting of solid material, nano powders or micro powders
  • the aforementioned fluid is selected from a group consisting of a liquid, gas, gel, emulsion, diluted solution, heterogenous solution, aggregates or liposomes.
  • the aforementioned gas is preferably carbon dioxide.
  • the implant comprises vertical (810) or horizontal compartments (horizontal compartments not shown).
  • the implant is adapted for insertion into the synovial space of joints of a human body, the joints selected from a group consisting of knee joint, ankle joint, shoulder joint ,hip joint, palm joint and spinal joints.
  • the implant is adapted for accommodating a video capsule of the GI type for monitoring the internal synovial joint environment.
  • the implant is adapted for accommodating an externally powered video camera.
  • Some embodiments of the invention are provided with a diagnostic window, hatch , flap or door (930) as schematically illustrated in fig 9 for observation, sampling or tool manipulation.
  • the tube(910) is adapted for accommodating a fibre optic external light source for illumination of the synovial joint. It will be appreciated that the opening of the tube sits just below the skin surface, sub- dermal Iy, and therefore it can be used to effect passage of materials in and out of the implant.
  • the tube is adapted for injecting or removing fluids, especially medicaments, powders, dyes or infill.
  • the tube is provided with a multiplicity of lumens, each lumen adapted for mediating specific functions selected from a group consisting of power supply, illumination, inner portion pressure control and adjustment, administration of medicaments, drainage of said implant, external video monitoring, administration of therapies, and withdrawal of biopsy samples.
  • the inner portion of the implant is provided with means for providing therapeutic vibrations. In fact, the implant is thus a vibrating effector.
  • the implant is thus a heating effector.
  • heating means is a peltier device.
  • the implant is thus a cooling effector.
  • cooling means is a peltier device or a saline circulation system.
  • the aforementioned inner inner portion is adapted to be inflated and deflated.
  • the inner inner portion can be inflated with gas or fluid via a lumen in the tube. It is herein acknowledged that pumping in (inflating) or withdrawal (deflating) of fluid or gas into the implant can be done before, during or after the artheroscopic procedure. It is herein acknowledged that the removal of fluids, gases, medicaments , abrasive materials, biologically active materials, and biologically inert materials may be carried out at predetermined times according to physician or health worker protocols during the period of residence of the implant within the synovial joint, according to the needs of the patient and the progress of the synovial regeneration process.
  • envelope portion is provided with a diagnostic window. It is herein acknowledged that such a window facilitates monitoring of the health status of the synovial joint in real time.
  • said implant is of dimensions such that a plurality of said implants can be stacked either vertically or horizontally in synovial space. Such stacking allows the physician to remove or add additional implants as required during the course of treatment.
  • the implant is removable from the knee after the healing period. Specific pressure on knee cartilage is lessened due to uniform distribution over the cartilage surface.
  • the implant embodies a specially coated padding softening mechanical contact between the implant and the knee cartilage. Additionally, the aforesaid implant can be adapted for shaping the cartilage during the healing period.
  • a flexible casing of the implant can be formed for shaping recovered cartilage.
  • Prolotherapy involves the injection of an irritant solution into the area where connective tissue has been weakened or damaged through injury or strain.
  • Many solutions are used, including Dextrose, Lidocaine (a commonly used local anesthetic), Phenol (an alcohol), Glycerine, or Cod Liver Oil extract.
  • the injection is given into joint capsules or where tendon connects to bone. Many points may require injection.
  • the Injected solution causes the body to heal itself through the process of inflammation and repair. In the case of weakened or torn connective tissue, induced inflammation and release of growth factor at the site of injury may result in a 30-40% strengthening of the attachment points.
  • the implants comprise at least one additional layer portion disposed between said envelope portion and said inner portion, wherein the envelope further comprise a series of apertures for sustained release of medicines into the joint space.
  • Intraarticular fractures are those in which the break crosses into the surface of a joint extending to the articular surface of the bone.
  • Surgical treatment of the fracture may be indicated when the potential risks of surgery are felt to be justified by the potential benefits of improving the alignment of the bones as they heal.
  • Hardware may be required to hold the fracture fragments in position. Even with surgery, the fracture is still prone to the problems noted above in addition to risks of surgery, such as infection, hardware related problems, numbness, tender scars, residual deformity, as well as less common problems such as anesthetic or drug related reactions, among others. Fracture position may shift even after reduction, internal fixation and immobilization. Future removal of hardware may be required. This type of injury may result in degenerative arthritis.
  • Embodiments of the invention useful for treating intra articular fractures are provided in general .
  • intra- articular hyaluronan injections may be efficacious in an knee which has developed osteoarthritis following intraarticular fracture.
  • Certain embodiments of the implant allow controlled delivery of intra-articular hyaluronan to a knee which has developed osteoarthritis following intraarticular fracture via the implant, thereby avoiding the use of injections and increasing efficacity.
  • Still other embodiments for treating intra articular fractures of the knee are implants delivering gold salts.
  • Still other embodiments of the invention are implants for treating intra articular fractures of the knee and other joints, adapted to deliver NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), steroid agents such as glucocorticoid and/or hyaluronic agents, for example, synvisc or hyaluronan.
  • NSAIDs Non-Steroidal Anti-Inflammatory Drugs
  • steroid agents such as glucocorticoid and/or hyaluronic agents, for example, synvisc or hyaluronan.
  • some embodiments of the aforesaid implants also has a reshaping function due to the implants surface which is provided with a raised textured external surface, or a surface comprising treads, bumps, indentations, nipples, roughenings or a combination thereof.
  • Fig9 schematically illustrates an embodiment of the implant used for treating intra articular fractures adapted for accommodating an externally powered video camera (940), the implant additionally provided with a communicating tube (910) extending from said implant outward to a subdermal location for communicating with the external power supply of said camera. More specifically it is herein acknowledged that in some embodiments of the invention devices and methods useful for treating Interarticular - fractures in the knee, ankle, elbow, shoulder, foot, wrist or hand. Some of these embodiments are adapted to release narcotics, medicaments, Cell Density Signal-1, CDS-I ,dextrose, glycerin hormones, local anti inflammatory drugs, gold salts and salts other than gold salts.
  • an implant is provided useful for repairing a tendon where there is loss of cartilageor a depression.
  • Silicone is a permanent conduit material that has been used for nerve grafting.
  • long- term tubulization of a nerve produces localized compression with resultant decreased axonal conduction, although total number of nerve fibers and axon size remain constant. Alterations in the blood-nerve barrier occur, followed by demyelination of the nerve fibers (19, 20).
  • Silicone tubes used for neural conduits must be removed to achieve apositive outcome (21). Similar unfavorable outcomes have been seen when using Gore-Tex vein grafts (WL Gore and Associates, Inc, Flagstaff, Ariz) as a nerve graft conduit (22, 23).
  • Gore-Tex polytetrafluorethylene
  • Polyglycolic acid (Dexon, American Cyanamid Co, Wayne, NJ) is a bioabsorbable substance that is currently used as a suturematerial (24) and in mesh form to wrap internal organs injured as a result of trauma (25). It is absorbed in the body by means of hydrolysis within 90 days of implantation (26, 27).
  • a bioabsorbable polyglycolic acid conduit has been developed for nerve grafting (Neurotube, Neurogen LLC, Bel Air, Md) and was approved by the Food and Drug Administration for human use in 1999 (Figure 3). Characteristics of this tube include 1) porosity, which provides an oxygen-rich environment for the regenerating nerve; 2) flexibility, to accommodate movement of joints and associated tendon gliding; 3) corrugation, to resist the occlusive force of surrounding soft tissue; and 4) bioabsorbability, eliminating the need for removal at a subsequent operation.
  • This corrugated tube has an internal diameter of 2.0 mm and a length of 4 cm.
  • group 1 consisted of standard repair with either end-to-end anastomosis or nerve graft
  • group 2 consisted of nerve repair using a polyglycolic acid conduit (28). There were no statistical differences between the 2 groups overall. However, 2-point discrimination was better in the polyglycolic acid conduit group (6.8 D ⁇ 3.8 mm) than in the direct anastomosis or nerve graft group (12.9 D ⁇ 2.4 mm).
  • the polyglycolic acid conduit provided superior results and eliminated donor-site morbidity.
  • Neurotube is a corrugated conduit composed of polyglycolic acid with an internal diameter of 2.0 mm and a length of 4 cm. Reference is herein made to embodiments of the invention such that the implants comprise the aforementioned materials to produce a temporary implant useful for alloplastic nerve grafting and cable nerve repair.
  • the problems associated with permanent tubing i.e., Silastic, Gore-Tex
  • compression and demyelination are eliminated.
  • the superior results achieved with this nerve grafting conduit are related to the elimination of the problems associated with a harvested nerve graft, host-donor differences in diameter, mismatches in number and pattern of fascicles and cross-sectional shape and area, and morbidity of the donor area. If there is a discrepancy in the sizes of host nerve end and tube diameter, the tube can be slit at the end to allow expansion or contraction to correlate to host nerve diameter.
  • the artificial nerve conduit is then filled with a solution containing 1000 U of heparin per 100 mL of isotonic saline to help prevent blood clot formation, which could impede axonal regeneration.
  • Tendon repair refers to the surgical repair of damaged or torn tendons, which are cord-like structures made of strong fibrous connective tissue that connect muscles to bones.
  • the shoulder, elbow, knee, and ankle joints are the most commonly affected by tendon injuries.
  • tendon repair is to restore the normal function of joints or their surrounding tissues following a tendon laceration.
  • Some embodiments of the present invention provide implants and methods of using thereof for tendon repair.
  • Still other embodiments provide implants delivering in situ Cell Density Signal- 1, or CDS-I or similar products to damaged tendons.Such products act as part of a chemical switch for turning on procollagen production.
  • inventions provide implants delivering dextrose or natural glycerin at the exact site of the injury to stimulate the immune system to repair the area.
  • Some embodiments of the implant release the aforementioned substances in order to causes an inflammatory reaction at the exact site of injuries to such structures as ligaments, tendons, menisci, muscles, growth plates, joint capsules, and cartilage to stimulate these structures to heal. This causes fibroblasts to multiply rapidly. Fibroblasts are the cells that actually make up ligaments and tendons. The rapid production of new fibroblasts means that strong, fresh collagen tissue is formed, which is what is needed to repair injuries to ligaments or tendons.

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Abstract

L'invention concerne un implant destiné à être utilisé dans le traitement d'un cartilage endommagé à l'intérieur d'une articulation, l'implant étant apte à être introduit dans une cavité de l'articulation et à réduire la contrainte sur le cartilage endommagé, engendrée, par exemple, par une activité de patient. L'implant peut former un coussin interne qui protège le cartilage contre des forces d'usure. L'effet d'amortissement facilite la régénération du cartilage.
PCT/IL2008/000456 2007-04-02 2008-04-02 Implant intra articulaire pour traiter des irrégularités dans des surfaces de cartilage WO2008120215A2 (fr)

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WO2013044174A2 (fr) 2011-09-23 2013-03-28 Orthosensor Composant de prothèse permettant de surveiller l'état d'une articulation
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EP2654625A1 (fr) * 2010-12-21 2013-10-30 Prosthexis Pty Ltd. Ménisques prosthétiques et procédé d'implantation dans l'articulation du genou humaine
US8661893B2 (en) 2010-06-29 2014-03-04 Orthosensor Inc. Prosthetic component having a compliant surface
US8679186B2 (en) 2010-06-29 2014-03-25 Ortho Sensor Inc. Hermetically sealed prosthetic component and method therefor
US8690888B2 (en) 2011-09-23 2014-04-08 Orthosensor Inc. Modular active spine tool for measuring vertebral load and position of load
US8696756B2 (en) 2010-06-29 2014-04-15 Orthosensor Inc. Muscular-skeletal force, pressure, and load measurement system and method
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US9271675B2 (en) 2012-02-27 2016-03-01 Orthosensor Inc. Muscular-skeletal joint stability detection and method therefor
US9332943B2 (en) 2011-09-23 2016-05-10 Orthosensor Inc Flexible surface parameter measurement system for the muscular-skeletal system
US9402583B2 (en) 2009-06-30 2016-08-02 Orthosensor Inc. Orthopedic screw for measuring a parameter of the muscular-skeletal system
US9414940B2 (en) 2011-09-23 2016-08-16 Orthosensor Inc. Sensored head for a measurement tool for the muscular-skeletal system
US9462964B2 (en) 2011-09-23 2016-10-11 Orthosensor Inc Small form factor muscular-skeletal parameter measurement system
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US9622701B2 (en) 2012-02-27 2017-04-18 Orthosensor Inc Muscular-skeletal joint stability detection and method therefor
US9700425B1 (en) 2011-03-20 2017-07-11 Nuvasive, Inc. Vertebral body replacement and insertion methods
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US9839523B1 (en) 2016-06-10 2017-12-12 Jared Ruben Hillel FORAN Antibiotic dispensing spacer apparatus and method for infected total knee arthroplasty
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CN108815573A (zh) * 2018-07-16 2018-11-16 江苏千汇轻量化技术研究院有限公司 一种应用热塑性碳纤维树脂基复合材料制成的人造骨关节
EP3498229A1 (fr) * 2017-12-18 2019-06-19 Tornier Implant pour la réparation et la régénération de tissus mous
US10582891B2 (en) 2015-03-23 2020-03-10 Consensus Orthopedics, Inc. System and methods for monitoring physical therapy and rehabilitation of joints
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FR3118576A1 (fr) 2021-01-07 2022-07-08 Didier POURQUIER Implant articulaire accueillant des cellules ostéochondrogéniques pour la reconstruction du cartilage articulaire
US11577000B2 (en) 2017-12-18 2023-02-14 Tornier In vitro method for creating a viable connective tissue and/or osseous tissue
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