Abstract
A cushion is disclosed 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.
Claims
1.-31. (canceled)
32. A method for implanting a cushion in a patient's knee joint between the patient's femur and tibia bones, the method comprising the steps of: providing the cushion made from a flexible material, with a fluid filling the interior of the cushion, fitting the cushion in the space between the patient's femur and tibia bones.
33. The method according to claim 32, wherein the cushion comprises a pocket made from a flexible material, and a fluid filling an interior of the pocket, the pocket being sized to fit in a space between the patient's femur and tibia bones.
34. The method according to claim 33, wherein the pocket is attached to the tibia and femoral bones so that the pocket is adapted to allow a gliding movement between the tibia and femur by means of the cushion's material flexibility and fluid movement.
35. The method according to claim 32, wherein the cushion has a first fixating section being attached to the cushion to the bottom of the femur at, at least a first point of attachment, and a second fixating section being attached to the cushion to the top of the tibia at, at least a second point of attachment so that, as the femur moves relative to the tibia when a patient bends his or her knee joint, the position of the first and second points of attachment are caused to move relative to one another in a direction substantially more perpendicular than parallel with a length axis of the tibia bone.
36. The method according to claim 32, wherein the cushion is sized and formed with a central portion through-hole or a tapered central portion, so as to allow accommodation of crucible ligaments extending between the femur and tibia, wherein the cushion has a size substantially corresponding to a menisci originally in the patient's knee joint between the patient's femur and tibia bones.
37. The method according to claim 36, wherein the pocket comprising a through going hole adapted to accommodate two interior crucible ligaments extending between the patient's femur and tibia bones.
38. The method according to claim 32, wherein the fluid is at least one of: a substantially incompressible fluid, a foam, and a gel.
39. The method according to claim 32, comprising an opening adapted to accommodate two interior crucible ligaments, wherein said opening is placed substantially in the center of the cushion through which the ligaments pass.
40. The method according to claim 32, wherein the cushion comprises a narrow section adapted to accommodate two interior crucible ligaments in a narrow center section of the cushion, that passes between the ligaments, so that the cushion is shaped substantially like a bow tie.
41. A cushion adapted to be implanted in a patient's knee joint between the patient's femur and tibia bones, the cushion comprising: a pocket made from a flexible material, and a fluid filling the interior of the pocket, the pocket being sized to fit in the space between the patient's femur and tibia bones, characterized in that the cushion further comprises an internal control unit adapted to be implanted and control the pressure in the implanted cushion, non-invasively when implanted, wherein the cushion, when implanted is adapted to allow pressure to be added to or removed from the fluid filling the cushion non-invasively, and wherein the cushion further comprises a pressure sensor connected to the cushion configured to, postoperatively when implanted, determine the level of pressure in the cushion, being connected to the implanted internal control unit.
42. The cushion according to claim 41, wherein the pocket is adapted to accommodate two interior crucible ligaments extending between the patient's femur and tibia bones.
43. The cushion according to any one of claims 41, wherein the cushion substantially has a size corresponding to the menisci originally in the patient's knee joint between the patient's femur and tibia bones.
44. The cushion according to claim 41, wherein the fluid is at least one of; a substantially incompressible fluid, water being a substantially incompressible fluid, a foam, a gel, and adapted to be included in the cushion of flexible material being a polymer type of material.
45. The cushion according to claim 41, wherein the cushion is comprised of a plurality of interior pockets filled with the fluid and isolated from another so that a rupture of one pocket results in the fluid draining from the ruptured pocket and not from the other pockets comprising the plurality of pockets.
46. The cushion according to claim 41, wherein the cushion has 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 so that, as the femur moves relative to the tibia when a patient bends his or her knee joint, the positioning of the first and second points of attachment are caused to shift relative to one another to accommodate a change in orientation between the femur and the tibia caused by the bending of the patient's knee joint.
47. The cushion according to claim 41, further comprising an apparatus adapted to be implanted in a patient that is connected to the valve arrangement for adding fluid to, or removing fluid from, the cushion, wherein the apparatus is comprised of: a fluid reservoir adapted to be implanted in the patient from which fluid is obtained or to which fluid is added for changing the level of fluid in the cushion, and a motor pump unit adapted to be implanted in a patient for transferring fluid from the fluid reservoir to the cushion and from the cushion to the fluid reservoir to thereby change the pressure in the cushion, wherein the apparatus further comprising; an external control unit including an external source of energy, and a wireless remote control transmitting to the internal control unit a control signal generated by the external source of energy.
48. The cushion according to claim 41, further comprising a second cushion positioned between the cushion and either the femur or the tibia bones so that two cushions are positioned between said bones, wherein the cushion has a first fixating section for attaching the cushion to the bottom of the femur at least a first point of attachment and the second cushion has a second fixating section for attaching the second cushion to the top of the tibia at least a second point of attachment.
49. The cushion according to claim 48, further comprising first and second flat metal plates positioned between the cushion and the second cushion, the first and second metal plates being attached to the cushion and the second cushion so that the plates are adapted to at least one of; slide relative to one another as the orientation between the femur and the tibia changes as the patient bends his or her knee, and being fixed relative to one another so that the first and second points of attachment are caused to shift relative to one another to accommodate a change in orientation between the femur and the tibia caused by the bending of the patient's knee joint.
50. The cushion according to claim 48, wherein the pressure sensor supplies to the internal control unit a signal representative of the level of pressure in the cushion, wherein the apparatus adds fluid to, or removes fluid from, the cushion, depending on the level of pressure in the cushion measured by the pressure sensor connected to the cushion.
51. The cushion according to any one of claims 41, further comprising an implanted injection port for adding fluid to, or removing fluid from, the cushion.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1A is a front elevational view of a healthy knee joint.
[0020] FIGS. 1B is a top view of the medial meniscus and the lateral meniscus separating and cushioning the upper and lower knee joint bones.
[0021] FIG. 2 is a front view of a conventional total knee replacement.
[0022] FIG. 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.
[0023] FIGS. 4A to 4E are top views of several embodiments of the cushion of the present invention.
[0024] FIGS. 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.
[0025] FIG. 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.
[0026] FIG. 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.
[0027] FIG. 7a 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. FIG. 7b is a side view of a knee joint in a flexed position with two of the cushions of the present invention implanted between a patient's femur and tibia
[0028] FIG. 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
[0029] FIG. 9 shows one embodiment of an injection port for adding fluid to or removing fluid from the cushion of the present invention.
[0030] FIGS. 10 and 11 show injection port of FIG. 9 working as a hand driven pump.
DETAILED DESCRIPTION OF THE INVENTION
[0031] FIG. 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. As shown in FIG. 3, 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. As such, preferably, the cushion 30 will be sized to fit into a patient's knee joint like the original menisci 20 and 22 shown in FIG. 1B. Preferably, 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. Preferably, the cushion 30 is made from a polymer type of material. Preferably the cushion 30 is coated for increased fatigue resistance.
[0032] As shown in FIG. 4A, 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.
[0033] FIG. 4B is a top view of another embodiment 30A 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 30A shown in FIG. 4B overcomes the rupturing problem of the cushion 30 of FIG. 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 30A, if the flexible material 34 fails. In this design, if the cushion 30A 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 30A 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.
[0034] As shown in FIGS. 4A and 4B, each of the cushions 30 and 30A 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 30B of the cushion shown in FIG. 4C. In the embodiment of FIG. 4C, the cushion 30B 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. It should be noted that the cushion 30B shown in FIG. 4C could be made with plurality of compartments 38 within which the substantially incompressible fluid 32 is stored, as shown in FIG. 4B, to again prevent a complete failure of cushion 30B where the flexible material 34 fails so as to cause only one of the plurality of compartments 38 to rupture.
[0035] 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.
[0036] FIG. 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.
[0037] According to another embodiment (not shown), 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, and 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.
[0038] As shown in FIGS. 6A, 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 50A and 50B. Similarly, 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. As such, as the femur 14 moves relative to the tibia 12 when the patient bends his or her knee joint 10, as shown in FIG. 6B, the positioning of the connection points 50A/50B and 52A/52B on the femur 14 and the tibia 12, respectively, is changed so that the connection points 50A and 50B shift relative to the connection points 52A and 52B, respectively, to accommodate a change in the orientation between the femur 14 and the tibia 12 caused by the bending of the patient's knee joint 10. This shift in the relative positioning of the attachment points 50A and 50B and 52A and 52B eliminates the sliding, and thus wear and tear, that occurs in conventional knee joint replacements, that that shown in FIG. 2 where an upper metal piece 13 of the upper knee joint slides relative to a lower plastic piece 23 of the joint as the joint is flexed.
[0039] In an alternative embodiment shown in FIG. 7A,7B, two cushions 35A and 35B can be inserted between a patient's femur and tibia. In this arrangement, the construction of each of the two cushions would be similar to that of the cushions described above and shown in FIGS. 4A to 4D. However, 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. 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. In this embodiment, 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. In a further alternative embodiment, 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. FIG. 7B shows the embodiment of FIG. 7A when flexed.
[0040] 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. As shown in FIGS. 4D, the embodiment 30C of the cushion includes a valve arrangement 73 for adding fluid to or removing fluid from the cushion 30C and a pressure sensor 75 for determining the level of pressure in the cushion. Where the cushion includes such a valve arrangement, 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.
[0041] FIG. 8 depicts one embodiment of an apparatus 67 for performing the function of adding fluid to or removing fluid from the cushion 30C to thereby change the pressure in cushion 30C, 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 30C via control line 65. An external control unit 60, shown to the left of skin 62 in FIG. 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 30C 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 FIG. 8. In this case, the cushion 30C 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 30C to increase the pressure of the fluid 32 in the cushion 30C. Conversely, hydraulic fluid is pumped by the motor/pump unit 68 back from the cushion 30C 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 30C. 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.
[0042] 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 A1, the entire contents of which are incorporated by reference in this application.
[0043] It should be noted that other injection port embodiments could be used with the cushion of the present invention.
[0044] Referring to the injection port embodiment disclosed in the referenced application publication, FIG. 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. According to the embodiment shown in FIG. 9, membrane 116 has a semi-spherical shape in its initial, “non-depressed” position, as shown in FIG. 9. In the embodiment shown in FIGS. 9-11, 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. However, in the most general embodiment of the injection port of the present invention, it is sufficient if 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.”
[0045] FIGS. 10 and 11 show injection port 110 of FIG. 9 working as a hand driven pump. By using a core for 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. FIG. 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 FIG. 11, where it is held by a locking device 132 until it is manually pressed again. When membrane 116 is actuated again, by a second push by the finger 126, 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 FIG. 9.
[0046] According to the method of using injection port 110 to add fluid to cushion 130, after injection port 110 is subcutaneously implanted in the patient, 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.
[0047] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
