WO2010059098A1 - Foam cushion for insertion in a knee joint - Google Patents

Foam cushion for insertion in a knee joint Download PDF

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Publication number
WO2010059098A1
WO2010059098A1 PCT/SE2009/000502 SE2009000502W WO2010059098A1 WO 2010059098 A1 WO2010059098 A1 WO 2010059098A1 SE 2009000502 W SE2009000502 W SE 2009000502W WO 2010059098 A1 WO2010059098 A1 WO 2010059098A1
Authority
WO
WIPO (PCT)
Prior art keywords
cushion
tibia
patient
femur
fluid
Prior art date
Application number
PCT/SE2009/000502
Other languages
English (en)
French (fr)
Inventor
Peter Forsell
Original Assignee
Milux Holding S.A.
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 Milux Holding S.A. filed Critical Milux Holding S.A.
Priority to US13/130,888 priority Critical patent/US20110288642A1/en
Priority to DK09827813.8T priority patent/DK2403436T3/da
Priority to EP09827813.8A priority patent/EP2403436B1/en
Priority to PL09827813T priority patent/PL2403436T3/pl
Priority to SI200932135T priority patent/SI2403436T1/sl
Priority to EP21170602.3A priority patent/EP3888599A1/en
Priority to HRP20211174TT priority patent/HRP20211174T1/hr
Priority to LTEP09827813.8T priority patent/LT2403436T/lt
Priority to ES09827813T priority patent/ES2880332T3/es
Publication of WO2010059098A1 publication Critical patent/WO2010059098A1/en
Priority to RU2016121916A priority patent/RU2712082C2/ru
Priority to PCT/SE2010/050826 priority patent/WO2011005207A1/en
Priority to RU2012104566/14A priority patent/RU2590861C9/ru
Priority to PCT/SE2010/050819 priority patent/WO2011005200A1/en
Priority to JP2012519515A priority patent/JP5859959B2/ja
Priority to ES16162583T priority patent/ES2900158T3/es
Priority to EP16162583.5A priority patent/EP3170476B1/en
Priority to ES10797406.5T priority patent/ES2559807T3/es
Priority to US13/383,368 priority patent/US20120203353A1/en
Priority to US13/383,293 priority patent/US9375315B2/en
Priority to EP10797413.1A priority patent/EP2451384B1/en
Priority to EP15194056.6A priority patent/EP3069690A1/en
Priority to CA3066331A priority patent/CA3066331C/en
Priority to PCT/SE2010/050818 priority patent/WO2011005199A1/en
Priority to US13/382,990 priority patent/US9180011B2/en
Priority to PT161625835T priority patent/PT3170476T/pt
Priority to BR112012000647A priority patent/BR112012000647B8/pt
Priority to AU2010269171A priority patent/AU2010269171B2/en
Priority to EP10797414.9A priority patent/EP2451385B1/en
Priority to CA3155273A priority patent/CA3155273A1/en
Priority to SI201032096T priority patent/SI3170476T1/sl
Priority to EP21188810.2A priority patent/EP3998045A1/en
Priority to US13/383,008 priority patent/US9155623B2/en
Priority to PL16162583T priority patent/PL3170476T3/pl
Priority to EP10797406.5A priority patent/EP2451407B1/en
Priority to HRP20211891TT priority patent/HRP20211891T1/hr
Priority to PCT/SE2010/050825 priority patent/WO2011005206A1/en
Priority to CA2805030A priority patent/CA2805030C/en
Priority to LTEP16162583.5T priority patent/LT3170476T/lt
Priority to US14/879,218 priority patent/US10966836B2/en
Priority to US14/935,482 priority patent/US10736745B2/en
Priority to JP2015246369A priority patent/JP6321616B2/ja
Priority to US15/193,184 priority patent/US10098744B2/en
Priority to AU2016250433A priority patent/AU2016250433B2/en
Priority to JP2018073245A priority patent/JP6549752B2/ja
Priority to US16/159,755 priority patent/US11957588B2/en
Priority to AU2018260921A priority patent/AU2018260921B2/en
Priority to JP2019119365A priority patent/JP6817377B2/ja
Priority to RU2020100114A priority patent/RU2808664C2/ru
Priority to US16/988,810 priority patent/US20210022869A1/en
Priority to AU2020223742A priority patent/AU2020223742B2/en
Priority to JP2020214769A priority patent/JP2021045651A/ja
Priority to US17/167,304 priority patent/US11752014B2/en
Priority to US17/215,026 priority patent/US20210282935A1/en
Priority to CY20211100668T priority patent/CY1124579T1/el
Priority to CY20211101077T priority patent/CY1125633T1/el
Priority to AU2022202444A priority patent/AU2022202444B2/en
Priority to US17/943,396 priority patent/US20230255779A1/en
Priority to US18/244,343 priority patent/US20230414378A1/en
Priority to JP2023151491A priority patent/JP2023164606A/ja

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3872Meniscus for implantation between the natural bone surfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30586Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid having two or more inflatable pockets or chambers

Definitions

  • the present application relates to knee joint repairs, and more particularly, to a cushion for insertion in a patient's knee joint that acts as a buffer between the patient's upper and lower knee bones.
  • FIGURE IA is a front view of a healthy knee joint 10.
  • the knee joint 10 includes an upper bone called the femur or "thigh bone” 12, two lower bones called the tibia or “shin bone” 14 and the fibula 16, and a patella or "knee cap” 18.
  • the upper and lower bones 12 and 14 are separated by two rubbery cushions or discs which are called the “medial meniscus” 20 and the “lateral meniscus” 22, which are best seen in the top view of FIGURE IB.
  • the upper and lower bones are also connected by ligaments, tendons and muscles (not shown) .
  • articular cartilage The surfaces of the upper and lower bones inside the knee joint 10 are covered by a layer of smooth, shiny cartilage called "articular cartilage" 24, which protects these bones, absorbs shock and provides a smooth, gliding surface for near frictionless movement of the bones as the knee joint 10 is flexed, bent or extended.
  • articular cartilage a layer of smooth, shiny cartilage
  • Sudden or acute injuries are the most common cause of knee problems.
  • One kind of acute injury is one or more tears occurring in one or both of the menisci 20 and 22 that serve to cushion the knee joint 10.
  • FIGURE 2 is a front view of a conventional total knee replacement, or "arthroplasty" 11 in which the end surfaces of the upper and lower knee bones 12 and 14 are relined with artificial parts or "prostheses".
  • the femoral (thigh) component 13 is made of metal and is inserted into the end 15 of the femur 12.
  • the tibia (shin bone) component 17 is made of a metal piece 19 that covers the end 21 of the tibia 14 and a polyethylene (medical-grade plastic) piece 23, which together cover the top end 25 of the tibia 14.
  • the metal piece 19 forms the base of the tibia component 17, while the polyethylene piece 23 is attached to the top of the metal piece 19 to serve as a cushion and smooth gliding surface for the metal femoral component 13.
  • the third component, the patella (kneecap) 27 may be all polyethylene or a combination of metal and polyethylene.
  • the present invention is directed to a cushion for insertion in a patient's knee joint to serve as a buffer between a patient's femur and tibia.
  • the cushion is filled with a substantially incompressible fluid, which can be a foam or a gel or a liquid, like water, which is capable of supporting the entire weight of the patient's body.
  • the cushion is preferably made from a flexible material that allows relative movement between the patient's femur and tibia, while resisting rupture as it supports these two bones as they are moving relative to one another as the knee joint is flexed, bent or extended.
  • the cushion is made from a polymer type of material.
  • the cushion has a single interior pocket or compartment which is filled by the substantially incompressible fluid.
  • the cushion can also be formed with a plurality of individual interior pockets or compartments within the overall cushion pocket which are filled by the substantially incompressible fluid.
  • the plurality of pockets or compartments allows the integrity of the cushion to remain largely intact so that the cushion can continue to buffer the upper and lower bones of a patient's knee, even where one of the cushion's compartments ruptures for one reason or another.
  • the plurality of pockets or compartments also provides, if there is extra pressure in one area, the ability to move fluid away from that area.
  • the cushion can also include an opening or hole in its center to accommodate the two interior crucible ligaments extending between the bottom of the femur and the top of the tibia.
  • the cushion can be shaped like a bow tie with a narrow center portion that can fit between the two interior crucible ligaments extending between the femur and tibia. Any other suitable shape may be used, depending on the situation in a patient's knee, such as for example where there are no crucial ligaments existing at all in a patient's knee.
  • a top side of the cushion is attached by suitable means to the bottom of the femur, while the bottom side of the cushion is attached to the top side of the tibia, so that as the femur moves relative to the tibia, when a patient bends his or her knee joint, the positioning of the points of attachment of the cushion to the femur and the tibia are caused to shift relative to one another to accommodate the change in orientation between the femur and the tibia caused by the bending of the patient's knee joint.
  • the cushion of the present invention can also include a valve arrangement that allows pressure to be added to or removed from the fluid filling the cushion to thereby change the level of support of a patient's body weight provided by the cushion.
  • a suitable pump and reservoir of fluid are implanted in the patient's leg to allow the fluid in the cushion to be adjusted and thereby change the pressure of the fluid within the cushion.
  • the cushion could simply be filled using an implanted injection port.
  • two cushions can be inserted between the patient's femur and tibia.
  • the construction of each of the two cushions would be similar to that described above.
  • the upper cushion would be attached on its upper side to the patient's femur, while the other, lower cushion would be attached on its lower side to the patient's tibia.
  • a pair of flat metal plates Positioned between the two cushions are a pair of flat metal plates that, in one embodiment, would slide relative to one another as a patient would flex his or her knee so that the orientation of the femur relative to the tibia would change.
  • the upper cushion would be attached on its lower side to the upper metal plate, while the lower cushion would be attached on its upper side to the lower metal plate.
  • the two metal plates would be fixed relative to one another so that flexing of a patient's joint would result in shifting of the fluid within each of the two cushions so as to accommodate a change in the orientation of the patient's femur relative to the patient's tibia as the patient's knee joint is flexed.
  • the cushion (s) can be inserted in a knee joint, either after the patient's menisci have been removed due to injury, or with the patient's menisci still in place, but diminished in their dimensions due to wear and tear on them.
  • the flexible pocket is adapted to at least partly be attached to the tibia and femoral bones, wherein the flexible fluid filled pocket is adapted to allow a friction free movement between the tibia and femur.
  • the movement is instead based on material flexibility and fluid movement
  • the cushion could also have a first fixating section for attaching the cushion to the bottom of the femur at, at least a first point of attachment and a second fixating section for attaching the cushion to the top of the tibia at at least a second point of attachment.
  • first fixating section for attaching the cushion to the bottom of the femur at, at least a first point of attachment
  • second fixating section for attaching the cushion to the top of the tibia at at least a second point of attachment.
  • the flexible pocket in both the first and second cushion is adapted to at least partly be attached to the tibia and femoral bones.
  • the flexible fluid filled pocket is adapted to allow friction free movement between the tibia and femur.
  • the movement is instead based on material flexibility and fluid movement.
  • the cushion could further comprise a first and second flat plate, positioned between the cushion and the second cushion, the first and second plates being attached to the cushion and the second cushion so that the plates slide relative to one another as the orientation between the femur and the tibia changes as the patient bends his or her knee, wherein said plates is adapted to be placed parallel to each other for allowing a larger weight carrying surface.
  • a method for implanting a cushion in a patient's knee joint comprises the steps of: placing a pocket made from a flexible material, with a fluid filling the interior of the pocket fitting in the space between the patient's femur and tibia bones.
  • FIGURE IA is a front elevational view of a healthy knee joint.
  • FIGURES IB is a top view of the medial meniscus and the lateral meniscus separating and cushioning the upper and lower knee joint bones.
  • FIGURE 2 is a front view of a conventional total knee replacement.
  • FIGURE 3 is a front view of a knee joint in an unflexed position with the cushion of the present invention implanted between a patient's femur and tibia.
  • FIGURES 4A to 4D are top views of several embodiments of the cushion of the present invention.
  • FIGURES 5A and 5B are top views of two of the embodiments of the cushion of the present invention showing their positioning on the top of a patient's tibia depicting how the cushion interacts with the two interior crucible ligaments extending from the top of the tibia to the bottom of the femur.
  • FIGURE 6A is a side view of a knee joint in an unflexed position with the cushion of the present invention implanted between a patient's femur and tibia.
  • FIGURE 6B is a side view of a knee joint in a flexed position with the cushion of the present invention implanted between a patient's femur and tibia.
  • FIGURE 7 is a side view of a knee joint in an unflexed position with two of the cushions of the present invention implanted between a patient's femur and tibia.
  • FIGURE 8 depicts one embodiment of an apparatus for performing the function of adding fluid to or removing fluid from the cushion of the present invention to thereby change the pressure in cushion
  • FIGURE 9 shows one embodiment of an injection port for adding fluid to or removing fluid from the cushion of the present invention.
  • FIGURES 10 and 11 show injection port of FIGURE 9 working as a hand driven pump.
  • FIGURE 3 is a front schematic view of a knee joint 10 in an unflexed position with the cushion 30 of the present invention implanted between a patient's femur 14 and tibia 12.
  • the cushion 30 of the present invention is intended to be inserted in a patient's knee joint 10 to serve as a buffer between the patient's femur 14 and tibia 12, not unlike the menisci originally separating and cushioning the patient's femur 14 and tibia 12.
  • the cushion 30 will be sized to fit into a patient's knee joint like the original menisci 20 and 22 shown in FIGURE IB.
  • the cushion 30 is filled with an substantially incompressible fluid 32, such as a foam or gel or liquid, like water, for example, which is capable of supporting the weight of a patient's body.
  • the cushion 30 is preferably made from a flexible material 34 that allows relative movement between the patient's femur 14 and tibia 12, while supporting the weight of the patient, and while resisting rupture of the cushion 30 as it buffers the femur and tibia while they are moving relative to one another.
  • the cushion 30 is made from a polymer type of material.
  • the cushion 30 is coated for increased fatigue resistance.
  • the cushion can be formed with a single compartment 36 within which is located the substantially incompressible fluid 32.
  • One difficulty with this design is the possibility of a complete failure of the cushion 30 where the flexible material 34 fails for some reason so that the single compartment 36 is completely ruptured, thereby allowing the fluid 32 in the compartment 36 to completely drain out of cushion 30.
  • FIGURE 4B is a top view of another embodiment 3OA of the cushion of the present invention containing a plurality of compartments 38 within which the substantially incompressible fluid 32 is located.
  • the cushion embodiment 3OA shown in FIGURE 4B overcomes the rupturing problem of the cushion 30 of FIGURE 4A, to a degree, in that the plurality of compartments 38 within which the substantially incompressible fluid 32 is stored can prevent a complete failure of cushion 3OA, if the flexible material 34 fails. In this design, if the cushion 3OA is ruptured, it is likely that only a single one of the plurality of compartments 38 will rupture so as to lose the fluid 32 located in that compartment.
  • the remaining un-ruptured compartments 38 comprising the cushion 3OA will then be able to continue supporting the patient's weight and femur 14 as it is moved relative to the tibia 12 as the patient flexes his or her knee. Furthermore the compartments prevents unwanted movements of the fluid.
  • each of the cushions 30 and 3OA includes an opening or hole 40 in its center to accommodate the interior crucible ligaments 42 extending between the center of the bottom of the femur 14 and the top of the tibia 12.
  • An alternative to this arrangement is the embodiment 3OB of the cushion shown in FIGURE 4C.
  • the cushion 3OB is shaped like a bow tie with a narrow center portion 44 that can fit between the two interior crucible ligaments 42 extending between the femur 14 and tibia 12.
  • cushion 3OB shown in FIGURE 4C could be made with plurality of compartments 38 within which the substantially incompressible fluid 32 is stored, as shown in FIGURE 4B, to again prevent a complete failure of cushion 3OB where the flexible material 34 fails so as to cause only one of the plurality of compartments 38 to rupture.
  • the knee joint comprises a prolonged femoral length axis, being the prolongation of the length axis of the femoral bone which passes the knee joint and continues substantially to the tibia length axis, when the leg is in its fully extended state.
  • FIGURE 4E shows an implantable system comprising a first and second cushion according to any of the embodiments herein, the first cushion is adapted to mainly be positioned on the medial side of the femoral length axis, and the second cushion is adapted to mainly be positioned on the lateral side of the femoral length axis, such that the first cushion is adapted to mainly carry a load originating from the weight of the patient distributed through the medial condyle, and the second cushion is adapted to mainly carry a load originating from the weight of the patient distributed through the lateral condyle, when the first and second cushions are implanted.
  • a system could further comprise a third cushion positioned between the first cushion placed at the medial condyle and either at the femur or the tibia bones so that two cushions are positioned between the bones.
  • the first cushion has a first fixating section for attaching the cushion to the bottom of the femur at, at least a first point of attachment
  • the third cushion has a third fixating section for attaching the third cushion to the top of the tibia at, at least a third point of attachment.
  • the system could further comprise a fourth cushion positioned between the second cushion and either the femur or the tibia bones at the lateral condyle, so that two cushions are positioned between the bones.
  • the second cushion has a second fixating section for attaching the cushion to the bottom of the femur at, at least a second point of attachment and the fourth cushion has a fourth fixating section for attaching the fourth cushion to the top of the tibia at, at least a fourth point of attachment.
  • the cushion 30 is attached by suitable means, such as by fixating sections in the form of a medical surgical adhesive or fasteners, to the femur 14 at the interface 31 of the top side of the cushion 30 and the bottom of the femur 14 at connection points 5OA and 5OB.
  • the cushion 30 is also attached by suitable means to the tibia 12 at the interface 33 of the bottom side of the cushion 30 and the top side 40 of the tibia 12 at second connection points 52A and 52B.
  • two cushions 35A and 35B can be inserted between a patient's femur and tibia.
  • the construction of each of the two cushions would be similar to that of the cushions described above and shown in FIGURES 4A to 4D.
  • the upper cushion 35A would be attached on its upper side to the patient's femur 14, while the other, lower cushion 35B would be attached on its lower side to the patient's tibia 12, again, by fixating sections in the form of a suitable medical surgical adhesive or suitable medical surgical fasteners.
  • a pair of flat metal plates 54 and 56 Positioned between the two cushions are a pair of flat metal plates 54 and 56 that, in one embodiment, would slide relative to one another as a patient would flex his or her knee so that the orientation of the femur relative to the tibia would change.
  • the upper cushion 35A would be attached on its lower side to the upper metal plate 54, while the lower cushion 35B would be attached on its upper side to the lower metal plate 56.
  • the two metal plates 54 and 56 would be fixed relative to one another so that flexing of a patient's joint would result in shifting of the fluid within each of the two cushions 35A and 35 B, so as to accommodate a change in the orientation of the patient's femur relative to the patient's tibia as the patient's knee joint is flexed.
  • FIGURE 7B shows the embodiment of FIGURE 7A when flexed.
  • the cushion of the present invention can also be constructed to allow pressure to be added to or removed from the fluid filling the cushion to thereby change the level of support of a patient's body weight provided by the cushion.
  • the embodiment 3OC of the cushion includes a valve arrangement 73 for adding fluid to or removing fluid from the cushion 3OC and a pressure sensor 75 for determining the level of pressure in the cushion.
  • a suitable pump and reservoir of fluid are implanted in the patient's leg to allow the fluid in the cushion to be adjusted and thereby change the pressure of the fluid within the cushion.
  • FIGURE 8 depicts one embodiment of an apparatus 67 for performing the function of adding fluid to or removing fluid from the cushion 3OC to thereby change the pressure in cushion 3OC, whereby the cushion provides greater or lesser buffering between the knee joint bones 14 and 12.
  • An implanted internal control unit 66 controls the pressure in the cushion 3OC via control line 65.
  • An external control unit 60 shown to the left of skin 62 in FIGURE 8, includes an external source of energy and a wireless remote control transmitting a control signal generated by the external source of energy. The control signal is received by a signal receiver incorporated in the implanted control unit 66, whereby the control unit 66 controls the pressure in the cushion 3OC in response to the control signal.
  • the implanted control unit 66 also uses energy from the control signal that is transmitted from external control unit 60 for operating, via a power supply line 64, the assembly 67 that includes a motor/pump unit 68 and a fluid reservoir 70, shown in FIGURE 8.
  • the cushion 3OC is hydraulically operated, i.e., hydraulic fluid is pumped by the motor/pump unit 68 from the reservoir 70 through a conduit 72 and valve arrangement 73 to the cushion 3OC to increase the pressure of the fluid 32 in the cushion 3OC.
  • hydraulic fluid is pumped by the motor/pump unit 68 back from the cushion 3OC to the reservoir 70, again through a conduit 72 and valve arrangement 73, to reduce the amount of fluid 32 and thus the pressure in the cushion 3OC.
  • the pressure is measured by pressure sensor 75, which is connected to control unit 66.
  • the external control unit 60 releases energy carried by a wireless signal and the implanted control unit 66 transforms the wireless energy into a current, for example, for powering the motor/pump unit 68 via electric power supply line 64.
  • the implanted control unit 66 controls the motor/pump unit 68 and the pressure in the cushion 30 via control lines 65 and 71.
  • the fluid supply could also, in it's easiest embodiment, only comprise an injection port that is preferably implanted subcutaneously .
  • One embodiment of an injection port is disclosed in patent application publication number US 2004/0064110 Al, the entire contents of which are incorporated by reference in this application. It should be noted that other injection port embodiments could be used with the cushion of the present invention.
  • FIGURE 9 shows an injection port 110 where a needle 112 of a syringe 114 has been injected through a membrane 116 attached to a rigid base member 18 of the injection port 110.
  • membrane 116 has a semi-spherical shape in its initial, "non- depressed" position, as shown in FIGURE 9.
  • membrane 116 is comprised of three layers attached to each other: a first hard layer 120 having preferably a hardness of more than 120 Shore; a second soft central layer 122 having a hardness of less than 20 Shore; and a third hard layer 124, having a hardness suitably more than 20 Shore, but preferably about 60 Shore or more.
  • Membrane 116 and base member 118 define a chamber 125 for fluid.
  • membrane 116 comprises two layers, i.e., one first hard layer and one second soft layer between chamber 125 and first layer 120.
  • First layer 120 has better strength properties than second layer 122, and second layer 122 has better sealing properties than first layer 120.
  • Membrane 116 's layers are suitably made of plastic or silicone, and preferably of silicone. Suitable silicon materials are manufactured by "Applied Silicone, Inc.”
  • FIGURES 10 and 11 show injection port 110 of FIGURE 9 working as a hand driven pump.
  • membrane 116 that is very soft, i.e., elastic silicone material of less than 20 shore, it is possible to create a thinner and more elastic membrane that could be pumped by hand and still not cause leakage when a needle 112 of a syringe 114 penetrates the membrane.
  • FIGURE 10 illustrates a finger 126 pushing (actuated by one push) membrane 116 in a direction 128 from above. Membrane 116 will then be substantially flattened, such that the surface that is faced against the finger 126 will assume a somewhat concave bowl-shape 130.
  • Membrane 116 is then moved to a lowest position, as shown in FIGURE 11, where it is held by a locking device 132 until it is manually pressed again.
  • the locking device 132 (which functions similar to the locking mechanism for a ballpoint pen) releases membrane 116, whereby membrane 116 is able to return to its regular convex-shaped condition as shown in FIGURE 9.
  • displaceable injection membrane 116 is used to pump fluid in fluid chamber 125 to cushion 130, which is hydraulically connected to injection port 110.
  • the amount of fluid in fluid chamber 125 capable of being pumped to restriction device 141 using injection port 110 is calibrated by penetrating the patient's skin and membrane 116 of injection port 110 with injection needle 112 of syringe 114 to add or withdraw fluid from chamber 125.
  • Membrane 116 is manually displaced from time to time to pump the fluid from chamber 125 of injection port 110 to implant 141 to operate the implant.

Landscapes

  • 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)
  • Orthopedics, Nursing, And Contraception (AREA)
PCT/SE2009/000502 2008-11-24 2009-11-24 Foam cushion for insertion in a knee joint WO2010059098A1 (en)

Priority Applications (59)

Application Number Priority Date Filing Date Title
US13/130,888 US20110288642A1 (en) 2008-11-24 2009-11-24 Foam cushion for insertion in a knee joint
DK09827813.8T DK2403436T3 (da) 2008-11-24 2009-11-24 Skumpolstring til indføring i knæleddet
EP09827813.8A EP2403436B1 (en) 2008-11-24 2009-11-24 Foam cushion for insertion in a knee joint
PL09827813T PL2403436T3 (pl) 2008-11-24 2009-11-24 Poduszka piankowa do umieszczenia w stawie kolanowym
SI200932135T SI2403436T1 (sl) 2008-11-24 2009-11-24 Penasta blazinica za vstavitev v kolenski sklep
EP21170602.3A EP3888599A1 (en) 2008-11-24 2009-11-24 Knee joint foam cushion
HRP20211174TT HRP20211174T1 (hr) 2008-11-24 2009-11-24 Pjenast jastuk namijenjen usadnji u zglob koljena
LTEP09827813.8T LT2403436T (lt) 2008-11-24 2009-11-24 Į kelio sąnarį įterpiama putplasčio pagalvėlė
ES09827813T ES2880332T3 (es) 2008-11-24 2009-11-24 Almohadilla de espuma para su inserción en una articulación de rodilla
RU2016121916A RU2712082C2 (ru) 2009-07-10 2010-07-12 Имплантируемое смазочное устройство
PCT/SE2010/050826 WO2011005207A1 (en) 2009-07-10 2010-07-12 Implantable medical device and method of implanting the medical device
RU2012104566/14A RU2590861C9 (ru) 2009-07-10 2010-07-12 Имплантируемое смазочное устройство
PCT/SE2010/050819 WO2011005200A1 (en) 2009-07-10 2010-07-12 Joint device and method
JP2012519515A JP5859959B2 (ja) 2009-07-10 2010-07-12 装置によって人体のまたは哺乳類患者を治療する植込み型注油装置および方法
ES16162583T ES2900158T3 (es) 2009-07-10 2010-07-12 Dispositivo de lubricación implantable
EP16162583.5A EP3170476B1 (en) 2009-07-10 2010-07-12 Implantable lubrication device
ES10797406.5T ES2559807T3 (es) 2009-07-10 2010-07-12 Aparato para tratamiento de artrosis u osteoartritis en una articulación de un mamífero o paciente humano
US13/383,368 US20120203353A1 (en) 2009-07-10 2010-07-12 Apparatus and methods for treatment of arthrosis or osteoarthritis in a joint of a mammal or human patient
US13/383,293 US9375315B2 (en) 2009-07-10 2010-07-12 Joint device and method
EP10797413.1A EP2451384B1 (en) 2009-07-10 2010-07-12 Implantable lubrication device
EP15194056.6A EP3069690A1 (en) 2009-07-10 2010-07-12 Implantable lubrication device
CA3066331A CA3066331C (en) 2009-07-10 2010-07-12 Implantable lubrication device and method of treating a human or mammal patient by means of the device
PCT/SE2010/050818 WO2011005199A1 (en) 2009-07-10 2010-07-12 Apparatus and methods for treatment of arthrosis or osteoarthritis in a joint of a mammal or human patient
US13/382,990 US9180011B2 (en) 2009-07-10 2010-07-12 Implantable circulating lubrication system for joints
PT161625835T PT3170476T (pt) 2009-07-10 2010-07-12 Dispositivo de lubrificação implatável
BR112012000647A BR112012000647B8 (pt) 2009-07-10 2010-07-12 dispositivo de lubrificação implantável
AU2010269171A AU2010269171B2 (en) 2009-07-10 2010-07-12 Implantable lubrication device and method of treating a human or mammal patient by means of the device
EP10797414.9A EP2451385B1 (en) 2009-07-10 2010-07-12 Implantable medical device
CA3155273A CA3155273A1 (en) 2009-07-10 2010-07-12 IMPLANTABLE LUBRICATION DEVICE AND METHOD OF TREATING A HUMAN OR MAMMALIAN PATIENT USING THE DEVICE
SI201032096T SI3170476T1 (sl) 2009-07-10 2010-07-12 Implantabilna mazalna naprava
EP21188810.2A EP3998045A1 (en) 2009-07-10 2010-07-12 Implantable lubrication device
US13/383,008 US9155623B2 (en) 2009-07-10 2010-07-12 Implantable medical device and method of implanting the medical device
PL16162583T PL3170476T3 (pl) 2009-07-10 2010-07-12 Wszczepialne urządzenie smarujące
EP10797406.5A EP2451407B1 (en) 2009-07-10 2010-07-12 Apparatus for treatment of arthrosis or osteoarthritis in a joint of a mammal or human patient
HRP20211891TT HRP20211891T1 (hr) 2009-07-10 2010-07-12 Implantabilni uređaj za podmazivanje
PCT/SE2010/050825 WO2011005206A1 (en) 2009-07-10 2010-07-12 Implantable lubrication device and method of treating a human or mammal patient by means of the device
CA2805030A CA2805030C (en) 2009-07-10 2010-07-12 Implantable lubrication device and method of treating a human or mammal patient by means of the device
LTEP16162583.5T LT3170476T (lt) 2009-07-10 2010-07-12 Implantuojamas tepimo įtaisas
US14/879,218 US10966836B2 (en) 2009-07-10 2015-10-09 Implantable medical device and method of implanting the medical device
US14/935,482 US10736745B2 (en) 2009-07-10 2015-11-09 Implantable lubrication device and method of treating a human or mammal patient by means of the device
JP2015246369A JP6321616B2 (ja) 2009-07-10 2015-12-17 装置によって人体のまたは哺乳類患者を治療する植込み型注油装置および方法
US15/193,184 US10098744B2 (en) 2009-07-10 2016-06-27 Joint device and method
AU2016250433A AU2016250433B2 (en) 2009-07-10 2016-10-27 Implantable lubrication device
JP2018073245A JP6549752B2 (ja) 2009-07-10 2018-04-05 装置によって人体のまたは哺乳類患者を治療する植込み型注油装置および方法
US16/159,755 US11957588B2 (en) 2009-07-10 2018-10-15 Joint device and method
AU2018260921A AU2018260921B2 (en) 2009-07-10 2018-11-08 Implantable Lubrication Device
JP2019119365A JP6817377B2 (ja) 2009-07-10 2019-06-27 人患者を治療する植込み型医療装置
RU2020100114A RU2808664C2 (ru) 2009-07-10 2020-01-09 Имплантируемое смазочное медицинское устройство для имплантации в сустав млекопитающего
US16/988,810 US20210022869A1 (en) 2009-07-10 2020-08-10 Implantable lubrication device and method of treating a human or mammal patient by means of the device
AU2020223742A AU2020223742B2 (en) 2009-07-10 2020-08-27 Implantable Lubrication Device and Method of Treating a Human or Mammal Patient by Means of the Device
JP2020214769A JP2021045651A (ja) 2009-07-10 2020-12-24 人または哺乳類である患者を治療する植込み型注油装置
US17/167,304 US11752014B2 (en) 2009-07-10 2021-02-04 Apparatus and methods for treatment of arthrosis or osteoarthritis in a joint of a mammal or human patient
US17/215,026 US20210282935A1 (en) 2009-07-10 2021-03-29 Hip Joint Method
CY20211100668T CY1124579T1 (el) 2008-11-24 2021-07-26 Μαξιλαρι αφρου για εισαγωγη σε αρθρωση γονατος
CY20211101077T CY1125633T1 (el) 2009-07-10 2021-12-08 Εμφυτευσιμη συσκευη λιπανσης
AU2022202444A AU2022202444B2 (en) 2009-07-10 2022-04-13 Implantable Lubrication Device and Method of Treating a Human or Mammal Patient by Means of the Device
US17/943,396 US20230255779A1 (en) 2008-11-24 2022-09-13 Foam cushion and method
US18/244,343 US20230414378A1 (en) 2009-07-10 2023-09-11 Apparatus and methods for treatment of arthrosis or osteoarthritis in a joint of a mammal or human patient
JP2023151491A JP2023164606A (ja) 2009-07-10 2023-09-19 装置によって人体のまたは哺乳類患者を治療する植込み型注油装置および方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US19339608P 2008-11-24 2008-11-24
US61/193,396 2008-11-24

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US13/130,888 A-371-Of-International US20110288642A1 (en) 2008-11-24 2009-11-24 Foam cushion for insertion in a knee joint
US17/943,396 Continuation US20230255779A1 (en) 2008-11-24 2022-09-13 Foam cushion and method

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EP (2) EP2403436B1 (da)
CY (1) CY1124579T1 (da)
DK (1) DK2403436T3 (da)
ES (1) ES2880332T3 (da)
HR (1) HRP20211174T1 (da)
HU (1) HUE055033T2 (da)
LT (1) LT2403436T (da)
PL (1) PL2403436T3 (da)
PT (1) PT2403436T (da)
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US10092405B2 (en) 2008-07-24 2018-10-09 Iorthopedics, Inc. Method of treating a patient's joint using a resilient arthroplasty device
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US10307257B2 (en) 2010-01-22 2019-06-04 Iorthopedics, Inc. Resilient knee implant and methods
US9662218B2 (en) 2010-01-22 2017-05-30 R. Thomas Grotz Resilient knee implant and methods
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US10307258B2 (en) 2010-01-22 2019-06-04 Iorthopedics, Inc. Resilient interpositional arthroplasty device
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US9757241B2 (en) 2011-09-01 2017-09-12 R. Thomas Grotz Resilient interpositional arthroplasty device
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EP2750629A2 (en) * 2011-09-01 2014-07-09 R. Thomas Grotz Resilient interpositional arthroplasty device

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Publication number Publication date
PT2403436T (pt) 2021-07-22
US20110288642A1 (en) 2011-11-24
EP3888599A1 (en) 2021-10-06
CY1124579T1 (el) 2022-07-22
EP2403436A4 (en) 2013-02-20
SI2403436T1 (sl) 2021-09-30
HRP20211174T1 (hr) 2022-01-07
US20230255779A1 (en) 2023-08-17
LT2403436T (lt) 2021-09-27
PL2403436T3 (pl) 2021-11-02
HUE055033T2 (hu) 2021-10-28
EP2403436A1 (en) 2012-01-11
ES2880332T3 (es) 2021-11-24
EP2403436B1 (en) 2021-04-28
DK2403436T3 (da) 2021-07-19

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