RU2808664C2 - Implantable lubricant medical device for implantation into the knee joint of a mammal - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: implantable lubricating medical device for implantation into a joint of a mammal contains an artificial contact surface, a reservoir, at least one channel, an operating device and an implantable inlet channel for replenishing the said reservoir. The artificial contact surface is configured to replace at least one contact surface of a joint and to be lubricated into the said joint after implantation. The reservoir contains a movable wall part defining the volume of the reservoir and at least one inlet hole configured to receive lubricating fluid from the reservoir. At least one channel at least partially embedded into the said artificial contact surface is fluidly connected to the said at least one inlet for distributing the said lubricating fluid over the surface of the said artificial contact surface. The operating device is configured to non-invasively transfer the said lubricating fluid from the said reservoir to the said artificial contact surface. The movable part of the wall is configured to move when the reservoir is refilled, increasing the volume of the reservoir.

EFFECT: invention provides an improved method of lubricating a damaged or worn joint of a human or mammalian patient, which on the one hand allows to provide sufficient lubrication of the joint, and on the other hand entails a minimal risk of infection.

16 cl, 83 dwg

Description

State of the art

[001] The present invention relates to an implantable lubrication device for lubricating a joint of a human or mammalian patient, an implantable lubrication system, and methods for treating a human or mammalian animal with the system.

In particular, the present invention is suitable for long-term or permanent introduction of a lubricating fluid into a joint, i.e. for its continuous or occasional administration over long periods of time, for example, over several years.

A lubricating fluid (synovial fluid) reduces friction between articular cartilage and other tissues in the joint and lubricates and cushions the bone and tissue components of the joint during movement. If the lubricating fluid has a negative effect and/or if the articular cartilage that normally covers the articular bone is damaged, as most cases occur in older patients and/or due to prolonged extensive or abnormal loading of human or mammalian joints (e.g., knee, hip), degenerative joint disease (also known as osteoarthritis), characterized by painful inflammation of the joint, may develop. When there is a pathological decrease and change in the composition of the lubricating fluid in the joint space, consisting of the articulating surfaces of the adjacent bones, where the joint is stabilized and surrounded by the joint capsule and synovium, the lubricating fluid can no longer perform its normal function, i.e. lubrication of joint areas and shock absorption, coupled with articular cartilage.

[002] If the articular cartilage is also severely damaged due to osteoarthritis or similar disease and/or if the synovial fluid is reduced or altered in its composition, thereby reducing the ability of the fluid to reduce joint friction, the articular surfaces are subject to significant friction and increased wear, resulting in to painful inflammation of the joint. This can lead to significant restrictions in freedom of movement, especially in standing and walking, which further aggravates the degenerative processes of the joint. Degenerative joint diseases are widespread in the West, and the disease is one of the leading causes of chronic disability in Europe and the United States.

Patients suffering from osteoarthritis require regular long-term treatment in which a lubricating fluid is injected into the affected joint, which on the one hand, as far as possible, restores the physiological functionality of the damaged joint, and on the other hand, causes a minimum of additional stress, such as physical , and psychological for the patient.

[003] A known standard treatment involves intermittent extracorporeal injection of a synthetic lubricating fluid into the joint space via a syringe to replace the missing physiological lubricating fluid. With this standard treatment method, the inconvenience to the patient is the delivery of the lubricating fluid into the joint through the skin and joint capsule at regular intervals via a syringe. In addition, this procedure can cause damage to the skin and joint capsule, which increases the risk of serious infections of the sensitive tissues of the joint. In view of the above, the injection can be carried out no more often than once every six months.

However, many patients require more frequent replenishment of the lubricating fluid, i.e. in the continuous replenishment of small volumes of lubricating fluid.

DISCLOSURE OF INVENTION

[004] It is therefore an object of the present invention to provide an improved method for lubricating a damaged or worn joint of a human or mammalian patient, which on the one hand provides sufficient lubrication of the joint, and on the other hand entails a minimal risk of infection.

The implantable lubricating device comprises firstly at least a reservoir for storing lubricating fluid and secondly, a fluid connection that introduces stored lubricating fluid into the injured joint when the lubricating device is implanted into the patient's body. The lubricating device can be completely implanted into the patient's body such that the damaged joint can be sufficiently lubricated after surgery from within the patient's body. This significantly reduces the risk of infection to the patient and allows the postoperative supply of lubricating fluid to the injured joint continuously, intermittently, periodically or as needed, for example, depending on the level of fluid in the joint.

The implanted lubrication system of the present invention comprises an implanted lubrication device and a lubricating fluid stored in a device reservoir that is inserted into the joint through a device fluid connection.

[005] Additional required or optional components of the implantable lubricant device, such as a reservoir, pump or motor, power source, control unit, may also be located entirely within the patient's body. Such components may be part of the implantable infusion device or may be an internal part of the implantable lubrication system separate from the actual implantable infusion device. Due to the fact that the implantable lubricating device can be completely implanted in the patient's body, i.e. The implanted lubrication system has both a storage function and a transfer function of the lubricating fluid inside the patient's body, the entire flow path of the lubricating fluid to lubricate the joint is located inside the patient's body. Therefore, the need for extracorporeal joint injections is eliminated.

The fluid connection comprises a fluid connection device connecting the reservoir of the implantable infusion device and the joint, thereby establishing a flow path for lubricating fluid from the reservoir to the joint. The fluid coupling device is also fully implantable, and preferably consists of a flexible tube or similar element suitable for postoperative transfer to the joint of lubricating fluid stored in a reservoir.

[006] In addition, the fluid connection includes an infusion element connected to the fluid connection device. The infusion element may be introduced into the patient's body at a site adjacent to or within a joint during surgery such that a lubricating fluid can be introduced into the joint after surgery. The infusion element may be configured to inject a lubricating fluid into the joint intermittently, for example periodically or when the fluid level drops below a predetermined threshold, for example as a result of being driven by a drive mechanism and depending on sensor data. In another preferred embodiment, the infusion element may also be configured to continuously introduce a lubricating fluid into the joint, for example, a predetermined volume of lubricating fluid over a specified period of time, for example, one drop per hour, or the like.

Intermittent or intermittent delivery may be provided, for example, by an infusion needle placed in the vicinity of the joint during surgery, whereby after surgery the needle can be periodically advanced into the joint into the correct position and retracted by a drive mechanism, allowing intermittent lubrication of the joint through the tip. infusion needle. The drive mechanism is configured to advance and retract the tip of the infusion needle into and out of the joint. Although the drive mechanism may be configured separately from the infusion needle and/or fluid connection device, it is nevertheless integral with the implantable lubricant device such that it is completely implanted in the patient's body.

[007] In yet another embodiment, the infusion element may include an infusion tube permanently positioned in the joint to continuously introduce a lubricating fluid into the joint. In this case, there is no need for a separate drive mechanism for advancing/retracting the infusion needle, since the infusion needle can be made of a sufficiently soft material that does not have any or no significant negative impact on the normal functioning of the joint. In this way, the infusion tube can be permanently placed within the joint, whereby lubricating fluid can be continuously introduced into the joint space.

Preferably, the reservoir of the implantable lubricant device includes a reservoir in communication with the fluid connection device for storing the lubricating fluid. The lubricating fluid is typically contained in a reservoir. The reservoir may be designed as a separate part of the implantable lubricant device, which is implanted separately into the patient's body. To establish the proper flow of lubricating fluid into the joint, the reservoir may be configured to vary the volume of the reservoir to create the proper pressure within the fluid coupling device and the infusion member to transfer the lubricating fluid into the joint.

Thus, at least a portion of the periphery of the reservoir may include a flexible outer wall to change the volume of the reservoir by deforming the flexible material as the reservoir is filled with lubricating fluid or as fluid is drawn from the reservoir, and to cause fluid to flow from the reservoir to the joint through fluid connection device.

[008] Therefore, the reservoir may be a balloon type reservoir. The flexible material may comprise a polymer membrane. A corrugated design with pre-curved pleats is preferred to reduce structural deterioration during long-term use. Drawing fluid from the reservoir into the fluid coupling device and into the joint may result in a decrease in pressure in at least a portion of the reservoir, resulting in a negative pressure compared to the pressure in front of the infusion needle or infusion tubing at the articular end of the fluid coupling device. . For example, the reservoir may comprise a gas chamber and a liquid chamber, said chambers being separated by a membrane, such as a polymer membrane, and acting as a spring to change the volume of the reservoir such that the pressure in the gas chamber is reduced as lubricating fluid is drawn from the liquid chamber into the coupling device for fluid medium.

The reservoir may also have a refill inlet for replenishing lubricating fluid from outside the human body into the implanted reservoir. Thus, the reservoir and fluid connection device implanted into the patient's body can be small in size since the reservoir can be easily refilled at suitable intervals. Preferably, the inlet channel includes a self-sealing material that seals the openings made by a refill syringe typically used to refill the reservoir through the patient's skin. Preferably, the lubricant device reservoir, or at least a self-sealing reservoir inlet, is implanted subcutaneously into the patient's body to provide easy access for refilling via a syringe.

[009] Although the reservoir may be manually compressed to introduce the lubricating fluid through the fluid coupling device and the infusion needle or infusion tube into the patient's joint, preferably a pump is attached to the device to provide communication between the reservoir and the infusion element for the purpose of pumping lubricating fluid from the reservoir to the joint. By means of the pump, the exact dose of lubricating fluid can be easily measured, and thereby the proper amount of lubricating fluid can be supplied continuously or intermittently to the joint.

The implantable pump preferably includes a valve device having a first and a second valve, each of which has a smooth surface facing each other to form a sealed contact between the first and second valves, and also having various fluid channels that can be aligned by moving the two smooth surfaces relative to each other while maintaining tight contact. This type of pump is described in detail in WO 2004/012806 A1. The first and second valves are preferably made of a ceramic material due to its excellent sealing properties over long periods of time, as well as its inertness to a variety of substances. The pump may be a diaphragm type pump, also described in WO 2004/012806 A1, but is not limited to this type of pump. A diaphragm type pump may include a membrane movable by a piston as it moves, the piston being coupled to a valve device to allow the first and second valves to slide relative to each other as the piston moves.

[010] Preferably, manual actuation of one of the pump or drive mechanism simultaneously causes activation of the other, i.e. drive mechanism or pump. For example, the pressure applied by the pump may cause the infusion needle to be advanced by the drive mechanism, and when the infusion fluid is delivered through the tip of the needle into the patient's body, the reduction in pump pressure allows a return spring or other resilient means to retract the infusion needle.

The implanted pump may be actuated by a mechanical remote control device, by a pressure regulator configured so that it can be operated manually when implanted subcutaneously in the patient's body, or by a sensing mechanism that senses the level of fluid in the joint and actuates a pump (and a drive mechanism for advancing and/or retracting the infusion needle), and driving the pump if the measured fluid level falls below a predetermined threshold.

Preferably, actuation of one of the pump or drive mechanism simultaneously causes activation of the other, i.e. drive mechanism or pump. For example, the pressure applied by a pump may cause the infusion needle to be advanced by a drive mechanism, and when lubricating fluid is delivered through the tip of the infusion needle into the patient's body, the reduction in pump pressure allows a return spring or other resilient means to retract the infusion needle.

At least one may be configured to operate a pump or, if used, a drive mechanism to advance and/or retract an infusion needle into or out of a joint, and to directly or indirectly generate a flow of lubricating fluid into the joint within the lubricating device. engine. The motor may be configured, for example, to provide electrical, magnetic or electromagnetic driving of the pump and/or driving mechanism, or to provide hydraulic driving of the pump and/or driving mechanism. Preferably, the motor is configured to drive one of the pump or drive mechanism, thereby causing the other to be driven simultaneously, i.e. drive mechanism or pump. The motor may also be configured to drive any other power consuming portion of the infusion device.

[011] The term "motor" in relation to the present invention includes any device that uses energy other than physical force and either automatically converts said energy into kinetic, hydraulic or other energy, or directly uses said energy to drive a pump, drive mechanism and/or other parts of the implanted lubrication device. Thus, the drive mechanism part may also form a motor part, for example in the case of an electromagnetically driven drive mechanism.

The motor forms part of the lubricating device and is implanted into the patient's body either separately from the lubricating device body for remote implantation into the patient's body or contained within the lubricating device body. Communication elements may be provided to conductively or wirelessly transfer energy from outside the device to the motor. For example, the motor may be configured to be driven wirelessly by an external electromagnetic field. It is also possible to provide an external power source for use outside the patient's body, such as a primary power source or battery, in particular a battery mounted on the patient's skin to power the pump and/or drive mechanism and/or other power-consuming part of the lubricant device. In particular, the energy source may be connected to at least one motor for driving said components. The external power source for wireless power transmission may be configured to generate an external field, such as an electromagnetic field, magnetic field, or electric field, or generate a wave signal, such as an electromagnetic or audio wave signal.

[012] If energy is wirelessly transmitted to the implanted lubricating device, a conversion device may be provided to convert the wirelessly transmitted energy into electrical energy. Preferably, said transducer device is configured to be placed directly under the patient's skin to minimize the distance and amount of tissue between the transducer device and the energy delivery means outside the patient's body.

A power transfer device for wirelessly transmitting power from a power source and/or power storage means to a converting device may be configured to generate an electromagnetic field. Alternatively or additionally, a power transmission device for wirelessly transmitting power may be configured to generate a magnetic field. In addition, the power transmission device for wireless power transmission may be configured to generate an electric field. Wireless power may also be transmitted by the power transmission device via at least one wave signal. Such a signal may comprise an electromagnetic wave signal including at least one of an infrared light signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, an RF signal, an x-ray signal, and a gamma signal. radiation. The wave signal may also comprise an audio or ultrasonic wave signal. In addition, wireless energy can be transmitted as a digital or analog signal, or a combination of both.

Instead of, or in addition to, an external power source, the implantable lubricating device itself may be provided with a power source. Said energy source may be part of the lubricating device or may be contained in its housing. However, the energy source can also be configured separately from the body of the lubricating device for remote implantation into the patient's body.

[013] Such an implantable energy source preferably includes energy storage means such as a long life battery or, more preferably, an accumulator. The advantage of a battery is that it can be recharged. Preferably, the battery comprises a battery and/or a capacitor.

In this case, communication elements may also be provided to transmit electrically conductive or wireless energy from a primary power source outside the device to a battery for charging the battery from outside the patient's body when the device is implanted in the patient's body. Likewise, the battery may include communication elements for providing electrically conductive or wireless power to at least one motor of the infusion device.

Although the at least one motor may be provided with driving means for manually operating the motor, it is preferable to also provide a control unit for controlling the at least one motor. The control unit may also be used to control the pump, drive mechanism and/or any other power consuming part of the implanted lubricant device, and in case the device contains an internal or external power source, the control unit may also be used to control said power source. The control unit can be adjusted to suit individual patient requirements, such as administering the proper amount of drug at the proper intervals. Automatic administration essentially provides assistance to the patient.

[014] Preferably, the control unit has a data communication port for transmitting data between an external processing device outside the patient's body and a control unit implanted in the patient's body, regardless of whether the control unit is contained in the body of the lubricating device or is implanted in the patient's body outside lubricator body. This data port allows control of the control unit to adapt the infusion device to the changing needs of the patient. Preferably, the data port is a wireless data port to enable free communication between the control unit and the data processing device, for example during a medical examination. Most preferably, the control unit is programmable to further enhance its adaptability.

The control unit - with or without a data port - can also be made extracorporeal, for example, it can be installed on the patient's skin. The advantage of an external control unit is that it is easier to access in case of problems. The control unit is preferably configured to wirelessly remotely control at least one motor implanted with the infusion device.

The control signal transmission device may be configured to wirelessly transmit an extracorporeal control signal to the implanted motor.

Likewise, a data communication interface may be provided to wirelessly transmit data from outside the patient's body to a control unit implanted inside the patient's body. Again, the wireless control signal and/or data transmission may comprise one of the above waveforms, being digital, analog, or a combination thereof. More preferably, the control signal may be transmitted in the same manner in which power is transmitted to the motor. For example, the control signal may be transmitted by modulating a power signal that serves as a carrier wave signal for a digital or analog control signal. In particular, the control signal may be a frequency, phase and/or amplitude modulated signal.

[015] Feedback means may be provided separately from or as part of the control unit to provide information about parameters relevant to patient treatment. These parameters may be physical parameters of the patient and/or process parameters of the device. For this purpose, at least one feedback sensor is provided to detect the specified parameters. For example, the feedback sensor may detect the level of lubricating fluid in the joint or other parameters related to the condition of the joint and its lubrication. The feedback sensors may be coupled to a control unit, which may include control software for controlling delivery of a lubricating fluid to the joint in response to at least one signal from the feedback sensors. Additionally or in another embodiment, the feedback data may be transmitted from the control unit to an external data processing device. This feedback data can be helpful in helping your doctor make a diagnosis.

Preferably, the fluid connection device consists of two fluid connection parts, each of which is connected to a reservoir and has at its open end an infusion element inserted into the joint space. The two parts of the fluid connection may be provided within the patient's body such that after surgery they form a circulatory path for the flow of lubricating fluid through the joint, i.e. from the pump and/or reservoir to the joint (via the first fluid connection portion) and back to the pump and/or reservoir (via the second fluid connection portion). Under pressure generated by the pump or the flexible outer wall of the reservoir, the lubricating fluid may circulate intermittently or continuously along the circulatory current path, with the second part of the fluid connection withdrawing the lubricating fluid into the joint space after the fluid has been introduced into the joint space by the first part of the fluid connection.

[016] Since, due to the circulatory path of current, the lubricating fluid is at least partially reused after passing through the joint, the fluid becomes contaminated with impurities or other foreign particles over time, which may reduce the quality and desired effect of the lubricating fluid. The circulating fluid connection device of the implantable lubricating device may thus comprise a filter device having a filter connected to the circulating current path for the purpose of removing contaminant particles from the contaminated circulating lubricating fluid. Preferably, the filter device is configured to regularly clean the filter and remove particles filtered from the lubricating fluid. Said removed impurities or foreign particles may then be placed in a sealed deposit space or may be returned to the patient's body, such as surrounding tissue, a blood vessel, or the like.

The lubricating device can be implanted into the patient's body at various locations, preferably as close as possible to the damaged joint that is to be lubricated. For example, it is possible to implant a lubricating device or part thereof into the thigh to lubricate the ball-shaped portion of the hip joint or knee joint. When the lubricant device or, for example, its reservoir has a relatively large volume, it may be preferable to implant the lubricant device with a completely filled reservoir, since refilling the reservoir in the abdominal cavity may be difficult. However, in this case it may be appropriate to use a subcutaneous replenishment inlet connected to the reservoir via a tube. In yet another embodiment, the lubricating device may also be implanted subcutaneously. If necessary, subcutaneous implantation allows for enhanced wireless transmission of energy and/or data to or from the lubricator. In addition, replenishment of the reservoir through a refill inlet via a refill syringe penetrating the patient's skin is greatly facilitated when the lubricant device is implanted subcutaneously.

Depending on the individual treatment, it may be preferable to implant a lubricating device into fatty tissue either intramuscularly or adjacent to a joint so that lubricating fluid can be introduced into a particular joint.

[017] In addition to the above-described lubricating device and its various components, the implanted lubrication system of the present invention includes a suitable lubricating fluid capable of being stored in a reservoir and introduced into the joint via an implanted fluid connection. Preferably, the lubricating fluid is resorbable and biocompatible to provide resorption and biological and chemical interaction with the synthetic lubricating fluid through the human body in the same manner as with a physiological lubricating fluid. Preferably, the lubricating fluid is hyaluronic acid or the like.

In one embodiment, an implantable medical device is configured to lubricate at least one artificial weight-bearing contact surface in a joint when implanted into said human or mammalian body, wherein said artificial contact surface replaces at least one of at least one of the two contact surfaces of a joint of a mammal, wherein said medical device further comprises at least one outlet configured to receive lubricating fluid from said reservoir, and wherein said medical device is operable to be controlled by an artificial operating device to distribute lubricating fluid from said reservoir. said reservoir and transferring it to at least one artificial contact surface.

The implantable medical device may have said reservoir and joint spaced apart, and includes a fluid connection path between the reservoir and the joint.

a. [018] An implantable medical device may have a reservoir configured to be placed subcutaneously or within a body cavity in an area of the patient's body selected from the group of areas consisting of:

b. abdominal region,

c. groin area,

d. pelvic area and

e. thigh area.

Thus, the implantable medical device can be placed in the abdominal cavity.

The replenishment inlet can be configured to be implanted subcutaneously or in connection with bone.

An implantable medical device may be configured to lubricate one artificial contact surface and an opposing contact surface of a hip or knee joint of a human or mammalian patient.

A knee joint having medial and lateral contact bearing surfaces, wherein said implantable medical device may be configured to lubricate said artificial contact surface on the medial aspect of the knee joint of a human or mammalian patient.

A knee joint having medial and lateral contact bearing surfaces, wherein said implantable medical device may be configured to lubricate said artificial lateral side contact surface on a human or mammalian knee joint.

A mammalian joint having at least two contact surfaces. The medical device is configured to lubricate at least one artificial contact surface replacing at least one of the mammalian joint contact surfaces at said joint. In addition, the medical device includes at least one inlet port configured to receive lubricating fluid from the reservoir.

[019] Typically, at least one channel is at least partially embedded in the artificial contact surface in connection with at least one inlet for distributing lubricating fluid across the surface of the artificial contact surface. The medical device may be configured to operate, controlled by the operating device, to distribute lubricating fluid from the reservoir. The ability to inject lubricating fluid intermittently or on demand reduces friction in the joint and allows for optimal levels of lubrication in the joint. According to one embodiment of the implantable medical device, the implantable medical device may be configured to distribute a lubricating fluid over the surface of the artificial contact surface on at least two portions of the artificial contact surface for the purpose of lubricating it. Distribution over more than one portion may provide a more uniform distribution of the lubricating fluid. In another embodiment of the medical device, the reservoir configured to hold the lubricating fluid may be an implantable reservoir located in a body cavity subcutaneously or in connection with bone. The implantable medical device may also include an operating device configured to transfer a lubricating fluid from said reservoir to the artificial contact surface to lubricate it.

[020] According to one embodiment, the reservoir may be configured to hold a lubricating fluid, and the operating device according to any of the embodiments disclosed herein may be configured to transfer the lubricating fluid from the reservoir to an artificial contact surface for its lubricants The working device may be mechanized and may contain a pump configured to pump fluid from the reservoir to the artificial contact surface to lubricate it. The operating device according to any of the embodiments disclosed herein may comprise a reservoir preloaded with a lubricating fluid under pressure. According to yet another embodiment, the implantable medical device may also include an implantable inlet port configured to preload the reservoir with pressurized lubricating fluid by insertion into the inlet port.

The implantable medical device, according to one embodiment, may also include a valve configured to close the connection between the reservoir and the artificial contact surface. The reservoir may be configured to be located in a block separate from the artificial contact surface and may be configured to be connected to the artificial contact surface via a channel.

The reservoir may include a movable wall portion configured to move and change the volume of the reservoir, wherein the wall portion may be a motorized wall portion that may contain a motor.

[021] In yet another embodiment, the implantable medical device may comprise at least one outlet and at least one additional channel at least partially embedded in the artificial contact surface. The medical device may be configured to circulate a lubricating fluid from the artificial contact surface through the outlet opening and into the artificial contact surface through the inlet opening. The circulation of the fluid may be accomplished by means of an operating device configured to circulate the lubricating fluid. The circulating system may include a reservoir configured to add fluid to the circulating lubricating fluid and/or a filter to purify the circulating lubricating fluid.

The operating device according to any of the embodiments may be configured to periodically transfer a lubricating fluid to the artificial contact surface.

An implantable medical device, in one embodiment, may comprise a sensor configured to sense a physical parameter within the joint or the pressure or volume of a lubricating fluid or a functional parameter of the operating device to control it to regulate the flow of lubricating fluid to the artificial contact surface.

[022] The reservoir according to any of the embodiments may be connected to the artificial contact surface through a channel. The inlet may include a connecting portion for connecting the channel to any part of the medical device. The channel according to any of the embodiments may contain several parts, which may be configured to be connected to each other by means of a connecting part. The first channel portion may be connected to the medical device, and the second channel portion may be connected to the reservoir. The channel, according to one embodiment, may be configured to pass through the bone of the patient's body to long-term maintain an open path through the bone, allowing the lubricating fluid to reach the artificial contact surface. According to another embodiment, the channel is configured to pass through the joint capsule of the patient's body to long-term maintain an open path through it, which allows the lubricating fluid to reach the artificial contact surface, and according to yet another embodiment, the channel is configured to pass through the pelvic bone with the back of the acetabulum and into the hip joint. The implantable medical device may be configured to lubricate the patient's hip joint; in this case, the artificial contact surface of the medical device may be configured to at least partially replace the contact surface of the acetabulum and/or femoral head.

The implantable medical device, according to one embodiment, may lubricate the second artificial contact surface. In one embodiment, the first artificial contact surface has a convex shape towards the center of the hip joint and the second artificial contact surface has a concave shape towards the center of the hip joint. The first artificial contact surface of this embodiment is configured to be attached to a human pelvic bone, and the second artificial contact surface is configured to be attached to a human femur. The artificial contact surface can be configured to be inserted into the hip joint through an opening in the pelvic bone, from the ventral side of the pelvic bone, a method of performing the operation that allows the articular capsule of the hip joint to be kept intact.

[023] The reservoir, in one embodiment, may be configured to be located within or at least partially within a bone of the patient, the bone may be, for example, the femur, pelvic bone, or femoral neck of the patient.

According to yet another embodiment, the reservoir may be configured to be placed subcutaneously or placed in a body cavity, which may be a cavity in a region selected from the group of regions consisting of: the abdominal region, the groin region, the pelvic region, and the thigh region.

An implantable medical device, according to one embodiment, may include an inlet port for filling the reservoir. The inlet channel may comprise a self-sealing membrane, which, for example, may be a parylene-coated silicone membrane. The inlet can be configured to be implanted subcutaneously, in connection with bone, or in a body cavity.

The reservoir may be configured to accommodate a lubricating fluid under pressure. To achieve pressure, the reservoir may be spring-loaded, contain a chamber configured to hold compressed gas, or contain an elastic wall configured to generate pressure. According to one embodiment, the reservoir contains a silicone elastic wall coated with parylene.

[024] In yet another embodiment, the implantable medical device is configured to lubricate a patient's knee joint. The lubricated artificial contact surface according to one embodiment may be configured to at least partially replace the femoral contact surface, which may be a tibia and/or femur contact surface.

According to one embodiment, the medical device is configured to lubricate at least one of the medial and lateral portions of the contact surface of the tibia of the knee joint, and according to yet another embodiment, the implantable medical device is configured to lubricate at least one of the medial and lateral part of the contact surface of the femur of the knee joint. In yet another embodiment, the medical device is configured to lubricate the femoral contact surface of the knee joint and the tibia contact surface of the knee joint.

In one embodiment, the reservoir according to any of the embodiments is capable of being replenished from outside the human body, which may be via an implantable inlet.

According to one embodiment, the reservoir is configured to maintain pressure, which can be increased by introducing a lubricating fluid through the inlet port.

[025] The implantable medical device according to any of the embodiments may be configured as part of a system that may also include at least one switch implanted in the patient to manually and non-invasively control the implantable medical device. The energized system allows the operating device to control the lubrication process performed by the medical device.

The system according to one embodiment may also include a hydraulic device having an implantable hydraulic reservoir that can be hydraulically coupled to the implantable medical device. The implantable medical device can be configured to be non-invasively controlled by manually pressing a hydraulic reservoir.

In yet another embodiment, the system may also include a wireless remote control device for non-invasively controlling the implantable medical device. The wireless remote control device may include at least one external signal transmitter and/or receiver, and also includes an internal signal receiver and/or transmitter implanted in the patient for receiving signals transmitted by the external signal transmitter or transmitting signals to an external signal receiver. The wireless remote control device may also be configured to transmit at least one wireless control signal to control the implantable medical device. The wireless control signal may comprise a frequency modulated signal, amplitude modulated signal, phase modulated signal, or a combination thereof. The wireless remote control device may also be configured to transmit an electromagnetic carrier wave signal to carry a control signal.

In yet another embodiment, the system may comprise a wireless power delivery device for non-invasively providing wireless power to implantable power consuming components of an implantable medical device. The wireless energy may comprise a wave signal selected from the following group: an audio wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, an RF signal, a signal in the form of X-ray radiation, gamma radiation signal, electric field, magnetic field, combined electric and magnetic field.

[026] The control signal in the system may comprise an electric field, a magnetic field, or a combined electric and magnetic field. The signal may comprise an analog signal, a digital signal, or a combination of an analog and digital signal. To power the energy-consuming components of an implantable medical device, the implantable system may include an implantable internal power source. According to yet another embodiment, the system includes an external power source for transmitting energy wirelessly, wherein the internal power source is chargeable by the energy transmitted wirelessly.

According to yet another embodiment, the system may also include a sensor or measuring device for determining or measuring a functional parameter associated with the transfer of energy to charge the internal energy source, and a feedback device for sending feedback data from inside the patient's body to the outside, where the feedback data may be associated with a functional parameter defined by a sensor or measured by a measuring device.

According to yet another embodiment, the system may also include a feedback device for sending feedback data from inside the patient's body to the outside, wherein the feedback data is associated with at least one of a physical parameter of the patient and a functional parameter related to the implantable medical device.

[027] The system according to one embodiment may also include a sensor and/or measurement device and an implantable internal control unit for controlling the implantable medical device in response to data associated with at least one of a physical parameter of the patient determined by the sensor or measurement device, and a functional parameter related to the implantable medical device as determined by the sensor or measured by the measuring device. The physical parameter, in one embodiment, may be pressure or motor activity.

A system according to one embodiment may comprise an external data transmitter and an implantable internal data transmitter coupled to the external data transmitter, wherein the internal transmitter supplies data related to the implantable medical device or patient to the external data transmitter and/or the external data transmitter supplies data to the internal data transmitter. data transmitter.

The system according to any of the embodiments disclosed herein may also include a motor or pump for operating the implantable medical device or a hydraulic operating device for operating the implantable medical device. The operative device may comprise a servo drive configured to reduce the force required by the operative device to operate the implantable medical device instead of operating the operative device for a long time, increasing the time of the specified action.

[028] In one embodiment, the system may also include an operating device for controlling an implantable medical device. The wireless energy in the wireless state can be used to directly drive the operating device to generate kinetic energy to operate the implantable medical device, as the wireless energy is transmitted by the energy transfer device. The system may also include a device for converting wireless energy transmitted by the energy transfer device from a first form of energy to a second form of energy.

The energy conversion device may be configured to directly power implantable energy consuming components of the implantable medical device with a second form of energy due to the conversion of a first form of energy transmitted by the energy transmission device into a second form of energy by the energy conversion device. The second form of energy may comprise at least one of direct current, pulsating direct current, and alternating current. The energy of the first or second form may comprise at least one of magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy, thermal energy, non-magnetic energy, non-kinetic energy, non-chemical energy, non-sonic energy , non-nuclear energy and non-thermal energy.

[029] To provide protection to the system or portions of the system, it may also include an implantable electrical component comprising at least one voltage level protector and/or at least one DC protector. A control device for controlling the transmission of wireless energy from the energy transmission device and an implantable internal energy receiver for receiving the transmitted wireless energy may be configured, wherein the internal energy receiver may be coupled to the implantable energy consuming components of the implantable medical device to directly or indirectly supply the received energy thereto; the system may also include a determination device configured to determine the energy balance between the energy received by the internal energy receiver and the energy used for implantable energy consuming components of the implantable medical device, wherein the control device may be configured to control the transmission of wireless energy from the external device for transmission energy based on the energy balance determined by the determination device.

The detecting device may be configured to detect a change in the energy balance, and the control device may be configured to control the transmission of wireless power based on the detected change in the energy balance. In turn, the sensing device may be configured to detect a difference between the energy received by the internal energy receiver and the energy used for implantable energy consuming components of the implantable medical device, and the control device may be configured to control the transmission of wireless energy based on the detected energy difference .

[030] The energy transmitting device may comprise a coil located outside the human body, which in turn may also include an implantable energy receiver for placement within the human body, and electrical circuitry coupled to the external coil to power it through electrical pulses for wireless transmission. energy, wherein the electrical pulses have leading and falling edges, and the electrical circuit is configured to vary the first time intervals between successive rising and falling edges and/or the second time intervals between successive falling and rising edges of the electrical pulses in order to vary the power of the transmitted wireless energy, wherein a power receiver receives transmitted wireless power having varying power. The electrical circuit may be configured to deliver electrical pulses that remain constant except for varying first and/or second time intervals.

The system, according to one embodiment, may have an electrical circuit having a time constant and configured to vary the first and second time periods only within the first time constant such that when the duration of the first and/or second time periods is varied, the power transmitted through the coil varies.

An implantable internal power receiver for receiving wireless energy may include a first internal coil, a first electronic circuit coupled to the first coil, and an external power transmitter for transmitting wireless power, wherein the power transmitter has a second external coil and a second electronic circuit coupled to the second coil, wherein the second outer power transmitter coil transmits wireless power received by the first power receiver coil, and the system further includes a power switch for turning on and off the connection of the first inner coil and the first electronic circuit such that the outer power transmitter receives feedback data related to charging of the first coil , in the form of a load resistance fluctuation of the second outer coil when the power switch turns on or off the connection of the first inner coil and the first electronic circuit.

[031] The system may also include an implantable internal power receiver for receiving wireless energy having a first internal coil, a first electronic circuit coupled to the first coil, and an external power transmitter for transmitting wireless power having a second external coil and second electronic circuitry coupled to the first coil. a second coil, wherein the second outer coil of the power transmitter transmits wireless energy received by the first coil of the power receiver, and the system further comprises a feedback device for reporting the amount of energy received in the first coil as feedback data, wherein the second electronic circuit includes a detector a device for receiving feedback data and for comparing the amount of energy transmitted by the second coil with feedback data relating to the amount of energy received in the first coil to obtain coupling coefficients between the first and second coils.

In embodiments in which the system includes a second outer coil that can be configured to move relative to the first inner coil to establish an optimal placement of the second coil that maximizes coupling ratio. The second external coil may also be configured to calibrate the amount of transmitted energy to obtain feedback data in the determination device until a maximum coupling coefficient is achieved.

[032] According to a second aspect, a method of implanting a medical device according to any of the embodiments disclosed herein is provided. The method includes the following steps: forming an opening extending from outside the human body into the joint, providing an artificial contact surface to the joint, attaching the artificial contact surface to the joint, implanting a reservoir into the human body, and lubricating the artificial contact surface with a lubricating fluid contained in the reservoir.

The step of lubricating the joint contact surface or artificial contact surface with a lubricating fluid contained in the reservoir may include implanting an operating device configured to transfer fluid from the reservoir to the artificial contact surface. According to another embodiment, the step of lubricating the artificial contact surface with a lubricating fluid contained in the reservoir includes providing an energy source to power the operating device.

According to yet another embodiment, the step of lubricating the joint contact surface or artificial contact surface with a lubricating fluid contained in the reservoir may include powering the operating device through a power source.

[033] The step of implanting a reservoir into the human body, according to one embodiment, may include the step of implanting an operating device built into the reservoir, which allows the step of lubricating the artificial contact surface with a lubricating fluid contained in the reservoir by means of the operating device transferring fluid from the reservoir to artificial contact surface.

Implanting the reservoir according to any embodiment may include the step of implanting the reservoir at least partially within the patient's bone, which may be the patient's femur, the patient's tibia, and/or the patient's pelvis.

The step of delivering the artificial contact surface may include the step of delivering the artificial contact surface to the ventral side of the pelvic bone.

The step of implanting the reservoir into the human body may comprise the step of implanting the reservoir subcutaneously. Subcutaneous placement of the reservoir allows for easier access to the reservoir and eliminates the need for a long duct between the inlet and reservoir.

The step of subcutaneously implanting the reservoir may include the step of implanting the reservoir in at least one region of the patient's body selected from the group of regions consisting of: the abdominal region, the groin region, the pelvic region, the thigh region, and the calf region.

[034] The additional step of implanting an inlet port to fill the reservoir may be performed. Implanting the inlet canal may include the step of implanting the inlet in connection with bone.

According to one embodiment, the medical device includes an artificial contact surface configured to bear a load in a patient's joint, and which may include at least one channel for carrying a lubricating fluid, and the method includes the following steps: implanting the medical device into a human joint, implanting channel configured to connect to a medical device, implanting an operating device for transferring lubricating fluid within the channel, implanting a reservoir configured to hold lubricating fluid, and, at least after surgery, transferring lubricating fluid from the reservoir to an artificial contact surface in the channel by means of the operating device, and further along the channel into the artificial contact surface, thereby allowing the lubricating fluid to be applied to the artificial contact surface.

Typically, the lubricating device can be implanted during standard surgery either endoscopically or laparoscopically. Further, it is necessary to distinguish between methods of implanting a lubricating device having an infusion needle for introducing lubricating fluid from time to time, and methods of implanting a lubricating device having an infusion tube for continuously introducing lubricating fluid.

[035] In a method of treating a human or mammalian joint, such as osteoarthritis of the human hip or knee, by providing the joint with a lubricating fluid via an implantable lubricant device, surgically dissecting a suitable location including the joint region is performed, which surgical intervention may particularly include cutting the patient's skin and cutting a suitable area for the lubricating fluid storage reservoir. The lubricating device is then placed at the appropriate site exposed by the incision such that the fluid connection allows lubricating fluid to be introduced into the joint after surgery. For this purpose, an opening is formed in the joint capsule in the dissected area of the joint and an infusion tube is inserted into the opening such that the open end of the infusion tube is positioned in permanent communication with the joint to ensure that the lubricating fluid stored in the reservoir is introduced into the joint on a permanent basis. after operation. That is, the infusion tube is inserted into the opening in such a way that, firstly, the open end of the infusion tube is in constant communication with the lubricated joint and, secondly, the infusion tube is in contact with the fluid connection device and, therefore, with the reservoir . After placing the lubricating device, the patient's body is closed such that the lubricating device is completely implanted in the patient's body. This procedure may preferably be performed in layers and by means of sutures or staples or adhesives and the like. Finally, after completion of the implantation procedure, postoperatively, a lubricating fluid is introduced into the reservoir such that the operation of the implanted lubricating device allows the joint to be sufficiently lubricated.

[036] In another embodiment, if the fluid connection includes an intermittently operating infusion needle as an infusion element, placement of the lubricant device on the dissected suitable joint area is accomplished by placing the infusion needle so close to the dissected joint area that the infusion needle drive mechanism can periodically insert an infusion needle into and out of the joint such that the lubricating fluid stored in the reservoir is periodically injected into the joint. That is, the infusion needle is placed in close proximity to the dissected area of the joint such that the needle can be periodically inserted into the joint to lubricate it and can subsequently be retracted by a suitable drive mechanism coupled to the drive mechanism or the like.

Another method of treating a human or mammal with an implantable lubricant device uses endoscopic or laparoscopic techniques to form an area of the joint through which a lubricating fluid can be introduced into the joint via an infusion element. Said joint area is formed by firstly expanding a cavity located in the immediate vicinity of the joint by inserting a needle-shaped or tubular instrument into the patient's body and introducing gas through the needle-shaped or tubular instrument to fill the tissue with gas and subsequently expand the cavity in the immediate vicinity of the joint . At least two laparoscopic/endoscopic trocars and a camera are then placed in the cavity, and at least one dissecting instrument is inserted into the cavity by means of the laparoscopic trocars. The joint area is then cut through the inserted dissecting instrument. In addition, a suitable area is cut to accommodate the remaining components of the lubricating device, such as a reservoir, pump or motor, etc. The lubricating device is then placed at a suitable site and a fluid connection to the infusion element is formed in the laparoscopically dissected area of the joint such that the lubricating fluid is introduced into the joint. After placement of the lubricating device, the patient's body is closed, resulting in the lubricating device being completely implanted in the patient's body. Then, after surgery, the lubricating fluid can be introduced into the reservoir such that the fluid connection device and the infusion element sufficiently lubricate the said joint.

[037] A laparoscopic approach can also be used to implant a lubricant device having an infusion tube or infusion needle. In the first case, the reservoir is placed at a suitable site, an opening is formed in the joint capsule in the laparoscopically dissected area of the joint and an infusion tube is inserted into the opening such that the open end of the tube is in continuous communication with the joint and the stored lubricating fluid can be continuously introduced into the joint. joint. In the second case, after placing the reservoir at a suitable site, the infusion needle and actuator are placed in close proximity to the laparoscopically dissected area of the joint so that the actuator can periodically insert (and retract) the infusion needle into (and out of) the joint to ensure time from the time of introduction of the stored lubricating fluid into the joint.

Closing the patient's body, or particularly the patient's skin, may, for example, include suturing, taping, and other suitable methods. The lubricating device can be placed subcutaneously in the patient's body, in adipose tissue, or intramuscularly. If necessary, the lubricating device may also be placed in or in close proximity to the patient's gastrointestinal or urinary tract. When the device is placed in close proximity to the tract, it can be attached to the gastrointestinal tract or urinary tract by means of a holder connected to a lubricating device. In yet another embodiment, the lubricating device may be located in the chest or abdomen of the patient. For example, a reservoir may be placed in the abdomen or chest. In another embodiment, the lubricating device or part thereof, such as a reservoir, can be implanted through open surgery; in this case, the chest or abdominal wall is opened to place the lubricating device at a suitable location within the patient's chest or abdomen, and then the skin and other layers of tissue are closed, for example by suturing, preferably layered. Refilling the reservoir preferably includes the step of introducing a volume of lubricating fluid through an inlet port connected to and/or integrated into a peripheral portion of the reservoir, such as a reservoir.

[038] Functional hip movements are understood to mean hip movements that at least partially correspond to natural hip movements. In some cases, the natural movement of the hip joint may be limited or altered to some extent after hip surgery, resulting in the functional movement of an artificially surfaced hip being somewhat different from the functional movement of a natural hip joint. The functional position of an implantable medical device or hip prosthesis is the position in which the hip joint can perform functional movements of the hip. The end position is understood to be a functional position in which no further change in the position of the medical device is required. Functional knee movements are defined as knee movements that at least partially correspond to natural knee movements. In some cases, the natural motion of the knee may be limited or altered to some extent after knee surgery, resulting in the functional motion of a knee with artificial surfaces being somewhat different from the functional motion of a natural knee. The functional position of an implantable medical device or knee prosthesis is the position in which the knee joint can perform functional movements of the knee.

A functional knee is a knee joint capable of performing functional movements of the knee with or without an implanted medical device or prosthesis. Full functional size refers to the size of the knee medical device when it is implanted in the knee joint.

[039] Arthroscopy is understood to mean a minimally invasive surgical procedure performed on a joint, and due to the fact that an arthroscopic procedure can be performed in the patient's abdomen, some steps of the procedure are more laparoscopic, but for the purposes of the present invention, the terms "arthroscopy" " and "laparoscopy" are synonymous, and the main reason for using these methods within the framework of the present invention is their minimal invasiveness.

The medical device of any embodiment may comprise at least one material selected from the group consisting of polytetrafluoroethylene (PTFE), perfluoroalkoxy copolymer (PFA), and tetrafluoroethylene-hexafluoropropylene copolymer (FEP). The material may also comprise a metal alloy such as cobalt-chromium-molybdenum alloy, titanium or stainless steel, or polyethylene such as cross-linked polyethylene or gas-sterilized polyethylene. It is also possible to use a ceramic material such as zirconium or zirconia ceramics or alumina ceramics in artificial contact surfaces or throughout the medical device. The portion of the medical device that is in contact with human bone to secure the medical device to the human bone may comprise a porous structure, which may be a porous micro- or nanostructure configured to promote ingrowth of human bone into the medical device to secure the medical device. The porous structure can be made by applying a hydroxyapatite coating or a rough open-cell titanium coating, which can be made by air plasma spraying; It is also possible to use a combination of a rough open-cell titanium coating and a hydroxyapatite topcoat. The contact parts may be made of a self-lubricating material, such as a waxy polymer such as PTFE, PFA, FEP, polyethylene or cross-linked ultra-high molecular weight polyethylene, or a powder metallurgy material, which may also be incorporated with a lubricant, preferably a biocompatible lubricant, such as a hyaluronic acid derivative. It is also possible that the material of the contact parts or surfaces of the present medical device is designed to be continuously or intermittently lubricated. In some embodiments, parts of the medical device may comprise a combination of metallic materials and/or carbon fibers and/or boron, a combination of metallic and plastic materials, a combination of metallic and carbon-based materials, a combination of carbon and plastic-based materials, a combination of flexible and rigid materials, a combination of elastic and less elastic materials, Corian and acrylic polymers.

[040] It should be noted that any embodiment or part of an implementation, as well as any method or part of a method, can be combined in any way. All the examples given must be considered as part of a general description, as a result of which they can generally be combined in any way. It should be noted that the description as a whole should be considered as a description of the device and method.

The various features of the embodiments described above may be combined in any way as long as the combination is not obviously inconsistent. Embodiments of the present invention are described below with reference to the accompanying drawings. Likewise, individual features of different embodiments may be combined or interchanged as long as the combination or substitution does not conflict with the overall function of the device.

Brief description of drawings

[041] In FIG. 1 shows a patient's body with an implanted lubrication device for lubrication of the hip joint and/or knee joint.

In fig. 1A and 1B show the hip joint and knee joint of FIG. 1, respectively, into which the infusion element of the implanted lubricating device is inserted; In fig. 1C shows a side view of the knee joint with the medical device completed.

In fig. 1D shows a cutaway view of a medical device according to one embodiment.

In fig. 1E shows the main components of the implanted lubrication device; In fig. 1F shows a motor-driven implanted lubricator establishing a circulatory current path. In fig. 2A shows an implanted lubricant device with an infusion needle and drive mechanism.

In fig. 2B schematically shows the lubrication device of FIG. 2A with some modifications. In fig. 2C is a cross-sectional view of an assembled embodiment of an implantable infusion device. In fig. 2D shows a motor driven pump unit suitable for use with the embodiment of FIG. 1F. In fig. 3 shows a medical device according to one embodiment comprising an artificial contact surface.

In fig. 4 is a cross-sectional view of a medical device according to one embodiment comprising an artificial contact surface.

In fig. Figure 5 shows a front view of a person with the hip joint visible. In fig. 6 shows a cross-sectional side view of a person undergoing a laparoscopic/arthroscopic procedure.

In fig. Figure 7 shows the hip joint in section when making a hole in the pelvic bone. In fig. Figure 8a shows the hip joint in section when a small hole is made in the pelvic bone. In fig. 8b shows a sectional view of the hip joint when the medical device is inserted through an opening in the pelvic bone. In fig. Figure 9a shows a sectional view of the hip joint as the medical device is inserted through an opening in the pelvic bone. In fig. 9b shows a sectional view of the hip joint when the medical device is inserted through an opening in the pelvic bone. In fig. 10 shows a cross-sectional view of the hip joint in the form of a medical device connected to an implantable lubrication system.

In fig. 11a-c illustrate a surgical instrument used in a method of making a medical device according to any of the embodiments disclosed herein.

In fig. 12b shows a cross-sectional view of the hip joint when the medical device is implanted and connected to the implantable reservoir. In fig. 13a shows a cross-sectional side view of the hip joint when a hole is made through the femur. In fig. 13b shows a cutaway view of the hip joint as the medical device is inserted through an opening in the femur. In fig. 13c shows a sectional view of the hip joint when the medical device is inserted through an opening in the femur.

In fig. 13d shows in more detail a reservoir configured to be connected to a medical device.

In fig. 14 illustrates the process of introducing lubricating fluid into the implantable inlet.

In fig. 15 shows an implantable medical device according to an opposite embodiment.

In fig. 16 shows a cross-section of a hip joint with an implantable medical device in the opposite embodiment.

In fig. 17 shows a cross-section of a hip joint with an implantable medical device in the opposite embodiment.

In fig. 18 is a cross-sectional view of a hip joint formed and connected to a reservoir implantable by a medical device of the opposite embodiment.

In fig. 19 is a front view of a human knee joint.

In fig. 20 is a front view of a human knee joint with a medical device installed.

In fig. 21 shows an implantable lubrication system.

In fig. 22a is a side view of a knee joint with a medical device mounted on the femur.

In fig. 22b shows a side view of the knee joint with a medical device on the tibia.

In fig. 23 shows a medical device comprising an artificial knee joint surface.

In fig. 24 shows a sectional view of a medical device comprising an artificial knee joint surface.

In fig. 25a shows a medical device comprising several medical device parts.

In fig. 25b shows an assembled medical device comprising several medical device parts.

In fig. 26 shows the placement of a medical device comprising multiple medical device parts when attached to the tibia.

In fig. 27 shows an implantable medical device, according to one embodiment, attached to the tibia, with the device connected to a reservoir and inlet port.

In fig. 28 shows a front view of a person with an implantable lubrication system installed.

In fig. Figure 29 shows the implantable lubrication system in more detail.

In fig. 30 shows an implantable circulatory lubrication system in more detail.

In fig. 31 shows in more detail an implantable circulatory lubrication system containing a filter.

In fig. 32 shows an implantable lubrication system for lubrication of an artificial hip joint surface.

In fig. 33a shows an implantable lubrication system including a retracting needle in a first position.

In fig. 33b shows an implantable lubrication system including a retractor needle in a second position.

In fig. 34 shows a system for treating a disease, the system comprising a device of the present invention implanted in a patient.

In fig. 35-49 schematically show various embodiments of the system for wireless power supply of the installation of FIG. 34.

In fig. 50 is a schematic block diagram illustrating an arrangement for supplying the precise amount of power used to operate the apparatus of FIG. 34.

In fig. 51 schematically shows an embodiment of the system in which the installation operates on wired power. In fig. 52 shows a more detailed block diagram of the arrangement for controlling wireless power transmission used to operate the installation of FIG. 34.

In fig. 53 shows an electrical diagram of the arrangement of FIG. 52 according to a possible implementation example. In fig. 54-60 show various layout options for hydraulic or pneumatic power supply to an installation implanted in a patient.

Detailed Description of the Invention

[042] The following is a detailed description of preferred embodiments. Like reference numbers in the drawings denote identical or corresponding elements. It should be understood that these drawings are provided by way of illustration and do not limit the scope of the invention in any way. Thus, any directional designations such as "up" or "down" refer only to the directions shown in the drawings. Furthermore, all dimensions and other similar information are provided for illustrative purposes only.

It should be noted that any embodiment or part of an implementation, as well as any method or part of a method, can be combined in any way. All the examples given must be considered as part of a general description, as a result of which they can generally be combined in any way.

In fig. 1 shows a patient's body with an implanted lubricating device consisting of a main body 1401 and two fluid connection tubes 1402 carrying lubricating fluid stored in a reservoir to the lubricated joints, in this case, the hip joint and the knee joint. For this reason, the main body 1401 contains a reservoir for storing lubricating fluid, and may also contain additional components such as a pump, motor, control unit and the like. Lubrication device, i.e. all its components are completely implantable in the patient's body in such a way that sufficient post-operative lubrication of the joint can be ensured independent of any extracorporeal components or injections, which significantly reduces the risk of infection to the patient. Depending on the type of joint and the extent of its damage, it may be lubricated intermittently/periodically, continuously or as needed, for example depending on the level of lubricating fluid in the joint. In general, the lubricator main body 1401 may be implanted subcutaneously to provide easy access, such as for refilling a reservoir or setting functions or operating modes via a wireless control unit, or the like.

[043] In FIG. 1A and 1B are two lubricated joints of FIG. 1, the hip joint and knee joint respectively are shown in more detail. According to FIG. 1A and 1B, the fluid connection tube 1402 has at its end an infusion element that is inserted into the joint capsule and transfers lubricating fluid into the joint. In fig. 1A shows an infusion needle 1403 inserted through the joint capsule into the hip joint space. The infusion needle 1403, in connection with a drive mechanism (not shown), can be advanced into and out of the joint space to provide periodic lubrication of the joint. In another embodiment, according to FIG. 1B, the infusion element is an infusion tube 1404 permanently positioned in the joint space such that a continuous flow of lubricating fluid reaches the joint. The material of the infusion tube 1404 may be a soft material that does not interfere (or only minimally interferes) with the normal function of the joint. For the infusion tube 1404 of FIG. 1B drive mechanism is not required.

In general, there are two main methods for implanting a lubricant device: a standard method, in which the joint area is dissected and an infusion needle 1403 or infusion tube 1404 is placed in the dissected area; and a laparoscopic method, in which the joint cavity is laparoscopically expanded and an infusion needle 1403 or infusion tube 1404 is positioned in the cavity via laparoscopic trocars. If the fluid connection tube 1402 terminates in an infusion needle 1403, as shown in FIG. 1A, the infusion needle 1403 is positioned adjacent to the joint capsule or in an opening in the joint capsule such that the needle drive mechanism can periodically introduce and retract the infusion needle 1403 into and out of the joint space such that the introduction of a lubricating fluid stored in the reservoir happens periodically. In another embodiment, fluid connection tube 1402 terminates in infusion tube 1404, as shown in FIG. 1B, a permanent opening is made in the joint capsule into which a tube is permanently placed so that lubricating fluid can be continuously introduced into the joint.

[044] In FIG. 1C illustrates a medical device according to an embodiment, wherein the medical device includes a first artificial contact surface 1101 configured to replace a distal surface of a femur 102 that is part of a knee joint. The first artificial contact surface 1101 may be configured to replace the surface of the lateral condyle, the medial condyle, or the lateral and medial condyles. The medical device of FIG. 1C further includes a second artificial contact surface 1102 configured to replace the tibia contact surface as another contact surface of the knee joint. The implantable medical device includes an inlet 1104 configured to receive lubricating fluid from a reservoir 1108, which in this embodiment is located on the back side of the tibia 102 and on the back side of the femur 102, respectively. According to this embodiment, the reservoir 1108 is configured to be refilled through an inlet passage 1107 located in a fluid connection with the reservoir 1108. The reservoir 1108 supplies lubricating fluid to the inlet 1104;1123 through a passage 1106 providing a fluid connection between the medical device and a reservoir 1108. According to this embodiment, the reservoir is configured to be pressurized through said inlet port 1108 containing a chamber for compressed gas further compressed when the reservoir 1108 is filled through the inlet port 1107. Inlet port 1104; 1123 transfers lubricating fluid to a channel 1105 at least partially embedded in said artificial contact surfaces 1101, 1102. According to the embodiment of FIG. 1, channel 1105 is completely integrated into the medical device. The channel 1105 distributes the lubricating fluid to the artificial contact surfaces 1101, 1102, and thereby lubricates the artificial contact surfaces 1101, 1102 and improves their performance due to reduced friction. The implantable medical device may also be configured to be implanted into the knee joint of another mammal, such as a horse.

[045] In FIG. 1D shows an implantable medical device according to an embodiment, wherein the medical device is configured to replace parts of the hip joint. The medical device includes multiple channels 1105 configured to lubricate the artificial hip joint contact surface with a lubricating fluid introduced into the channel through a channel 1106 centrally located in the implantable medical device. The channel 1106 provides a fluid connection of several channels 1105 with a reservoir 1108 located in the stem portion of the specified medical device, configured to be secured in the femur of a person. Channel 1106 carries lubricating fluid to inlet 1123 for further distribution through channels 1105. According to the embodiment of FIG. 1D, the reservoir 1108 is spring-loaded by a spring 1109 that pushes a movable wall portion in the form of a piston 1110 to place said lubricating fluid under pressure. The reservoir 1108 is configured to be refilled through an inlet 1107 located on the side of the medical device. The introduction of lubricating fluid through the inlet passage 1107 compresses the spring 1109, which places the lubricating fluid under pressure, which forces the lubricating fluid through the passage 1106 to the lubrication passages 1105 of the human hip joint. The spring-loaded reservoir 1108 may be replaced by other types of reservoirs configured to place a lubricating fluid under pressure, such as a reservoir 1108 containing a chamber filled with compressed gas further compressed due to the introduction of the lubricating fluid through the inlet port; it is also possible that the reservoir 1108 is an elastic reservoir, in which case the elastic properties of the elastic reservoir exert pressure on the lubricating fluid.

[046] In FIG. 1E shows an implanted medical device and its main components. The lubrication device according to FIG. 1E includes a reservoir R for storing lubricating fluid and a fluid connection tube 1402 connecting the reservoir R to an infusion tube 1404 positioned such that its open end is permanently positioned in the joint space. To generate sufficient pressure to force lubricating fluid from reservoir R through fluid connection tube 1402 and infusion tube 1404 into the joint, a gas chamber 1407 is provided within reservoir R to provide the required pressure as the volume of the chamber expands. In addition, the reservoir is implanted subcutaneously such that a refill inlet 1406 formed on the outer wall of the reservoir R is accessible through the skin of the patient 1405 such that the reservoir R can be replenished with lubricating fluid through a syringe inserted through the skin of the patient 1405. Thus, , the refill inlet 1406 may be made of a suitable membrane, for example, a polymeric material that is self-sealing against penetration of the injection syringe.

In fig. 1F shows another embodiment of a lubricating device according to the present invention. The pump P, driven by the motor M, connects the reservoir R to a fluid circulatory connection tube 1402, consisting of two parts of the tube 1402a, 1402b forming a complete circulatory current path for the lubricating fluid through the reservoir R and the lubricated joint. Each of the two tube portions 1402a, 1402b includes a separate infusion tube 1404a, 1404b introduced into the joint space, where lubricating fluid stored in the reservoir is introduced into the joint space through the tube portion 1402a with the infusion tube 1404a, and the used lubricating fluid is withdrawn from joint back into the reservoir through tubing portion 1402b with infusion tubing 1404b and through filter device 1427 with filter 1428 placed in a flow path partially defined by tubing portion 1402b. Under the pressure generated by the pump P, the lubricating fluid continuously circulates in the circulatory current path formed by the fluid connection tube portions 1402a, 1402b so that the lubricating fluid after passing through the joint can be at least partially reused. However, to ensure reuse of the lubricating fluid flowing from the joint into the infusion tube 1404b, possible contaminants and impurities or other foreign particles introduced into the lubricating fluid as it passes through the joint are removed by the filter device 1427 to ensure the quality and desired effect of the lubricating fluid. fluid when reused. The filter device 1427 has a filter 1428 located in the current path such that all lubricating fluid passes through the filter. The filter device 1427 is configured to regularly clean the filter 1428 by removing filtered particles from the filter 1428 and placing them in a sealed sediment space 1433. Alternatively, the removed particles may also be returned to the patient's body, such as a blood vessel or the like.

[047] Although the embodiment of FIG. 1F may contain a variety of types of reservoir, and a specific type of reservoir is described below. The volume of the reservoir R shown in FIG. 1F is divided into two sections by the membrane 1429. One section is filled with gas, and the other section is filled with lubricating fluid. Refill inlet 1430 replenishes reservoir R with infusion fluid via a refill needle through the patient's skin 1405. When reservoir R is full, the gas compartment is at atmospheric pressure or pressurized. As lubricating fluid is drawn from reservoir R during each lubrication cycle, the pressure in the gas compartment is reduced to below atmospheric pressure, i.e. to a negative relative value. Depending on the type of pump P, it may be preferable to provide an active spherical valve 1431 for the purpose of preventing backflow from the pump P into the reservoir R, and another active spherical valve 1432 for the purpose of preventing backflow from the reservoir R into the fluid connection path 1402b.

The motor M is controlled wirelessly by a control unit C also implanted in the patient's body. However, the control unit C can also be placed outside the patient's body, and wireless communication can be established between the control unit C and the motor M; or galvanic contacts can be made through the patient's skin. Preferably, the control unit C is implanted together with the motor M, wherein the control unit C is preferably programmable from outside the patient's body wirelessly or via galvanic contacts in order to ensure that the control unit is properly configured in accordance with changing requirements. The control unit C determines the time interval between infusion cycles, as well as the amount of lubricating fluid introduced into the joint space during each infusion cycle. In addition to or instead of the control unit C, a subcutaneous pressure regulator can be provided to drive the motor M.

[048] There are many ways to provide energy to the M motor. For example, energy may be supplied from outside the patient's body, for example, to charge a battery A, such as a battery and/or a capacitor. In the embodiment of FIG. 1F, the extracorporeal primary energy source E transmits energy of a first form through the skin of a patient 1405 to an energy conversion device T that converts the energy of the first form into energy of a second form, such as electrical energy. Electrical energy is used to recharge battery A, which provides secondary energy to engine M as needed.

In general, the external energy source E may be configured to generate an external field, such as an electromagnetic field, magnetic field, or electric field, or generate a wave signal, such as an electromagnetic or audio wave signal. For example, the energy conversion device T of FIG. 1F can act as a solar cell, but is adapted to the specific type of wave signal of the primary energy source E. The energy conversion device T may also be configured to convert changes in temperature into electrical energy. Instead of an external primary energy source E, an implantable primary energy source E such as a conventional long-life battery may be used instead of battery A. The energy signal can also be used to transmit a control signal to the control unit C by appropriately modulating the energy signal regardless of whether , energy is transmitted wirelessly or wiredly, whereby the energy signal serves as a carrier wave signal for a digital or analog control signal. In particular, the control signal may be a frequency, phase and/or amplitude modulated signal.

[049] In FIG. 2A shows in detail an implanted lubricant device comprising an infusion needle 1403 having a tip 1408. The tip 1402 is closed at the distal end, and has a side outlet 1409 for delivery of lubricant fluid. The needle 1403 is configured to move longitudinally within the open-ended fluid connection tube 1402 when actuated by a drive mechanism D.

The fluid connection tube 1402 is attached to the implanted pump P. The pump P is shown schematically and can be configured in a variety of ways. In fig. 2A, a reservoir R holding lubricating fluid introduced into the patient's joint space is part of the pump P. Alternatively, the reservoir R may be separate from and connected to the pump P, for example, as substantially shown in FIG. 2B. However, in FIG. 2A, a movable or flexible pump wall 1410 P, which may be in the form of a piston or the like, is electrically (or manually) movable to periodically pump lubricating fluid from reservoir R through fluid connection tube 1402 in the direction to the infusion needle 1403. Pump P may be, for example, motor driven, and the motor may be controlled automatically to inject a specified volume of lubricating fluid into the joint space at specified intervals from time to time through the infusion needle 1403. Reservoir R, pump P and/or other components of the implanted lubricant device, such as the aforementioned motor, automatic motor control device, etc., are preferably implanted along with the infusion needle 1403 and the drive mechanism D. Naturally, other suitable modifications are possible, as will be evident upon detailed consideration of other embodiments of the present invention. .

[050] In the lubricating device shown in FIG. 2A, the increase in pressure in the reservoir R due to the actuation of the movable/flexible wall 1410 causes the infusion needle 3 to move in a direction opposite to the force of the spring 1411 of the drive mechanism D. Thus, the tip 1408 of the infusion needle 1403 extends into the lubricated joint space. When the return spring 1411 is fully compressed and the pressure exerted on the lubricating fluid by the movable/flexible wall 1410 is further increased, the spherical valve 1412 moves in the opposite direction of the second return spring 1413 having a greater force than the first return spring 1411. In this case, by maintaining a sufficiently high pressure level, lubricating fluid will be pumped from the reservoir R through the fluid connection tube 1402, the hollow infusion needle 1403, and the needle outlet 1409 into the joint space of the patient. After the pressure is released, the spherical valve 1412 closes due to the action of the return springs 1411 and 1413, after which the infusion needle 1403 is retracted to its original position, as shown in FIG. 2A. This process is repeated periodically depending on the condition and type of joint being lubricated, which allows for periodic lubrication of a specific joint.

It should be noted that the force exerted on the infusion needle 1403 to advance can be calculated as the product of the actual pressure and the cross-sectional area of the needle 1403. Since the cross-sectional area of a conventional infusion needle is relatively small, it is necessary to penetrate into the joint space and overcome the opposing forces of return springs 1411 and 1413 require high pressure. Thus, it is preferable to design the drive mechanism D in such a way that there are two strictly separated chambers in front of the drive mechanism and behind it. Thus, when the chamber behind the actuator D is held under a low pressure such as atmospheric pressure, the force exerted on the infusion needle 1403 corresponds to the product of the actual pressure and the total cross-sectional area of the actuator D, and therefore the force is significantly higher.

[051] This principle is shown in FIG. 2B. The drive mechanism D includes a piston 1414 to which an infusion needle 1403 is attached, as shown in FIG. 3. The piston 1414 separates a first chamber 1415a in front of the piston 1414 and a second chamber 1415b behind the piston 1414. While the pressure in the first chamber 1415a matches the pressure generated by pump P, the pressure in the second chamber 1415b can be maintained at a lower pressure. For example, chamber 1415b may be filled with a compressible gas. In this case, you do not need to use the return spring 1411, since the compressed air independently creates the force to retract the needle.

However, tightly sealing the gas chamber presents a certain difficulty. For this reason, the second chamber 1415b is instead filled with a fluid, such as a lubricating fluid, and the liquid can be forced into the flexible volume 1416. The flexible volume 1416 can be configured as a simple balloon, which allows it to be filled without causing significant opposing forces. . In another embodiment, the flexible volume 1416 may contain a gas chamber separated from the fluid of the second chamber 1415b by a flexible membrane. In this case, it is also possible to omit the return spring 1411.

[052] Instead of flexible volume 1416, conduit 1417 (acting as fluid connection tube 1402) may connect second chamber 1415b to reservoir R. Thus, as the infusion needle 1403 is advanced, fluid is forced from second chamber 1415b through conduit 1417 into reservoir R and when the infusion needle 1403 is retracted by the return spring 1411, fluid is drawn from the reservoir R through the channel 1417 back into the second chamber 1415b. The pump P and reservoir R are implanted into the patient's body along with the drive mechanism D and the needle 1403 separately or, if necessary, as a single unit.

In fig. 2C shows a highly compact lubricating device implanted subcutaneously in close proximity and in an appropriate position relative to the joint being lubricated so that the needle 1403 can be periodically advanced into the joint when actuated by a drive mechanism D. The individual components of the device are contained within a common housing 1418 containing an outer wall 1419a, 1419b. The volume defined by the outer wall 1419a, 1419b is completely filled with lubricating fluid. The wall portion 1419a is flexible to accommodate volume changes that occur with each insertion and refill. The wall portion 1419a is made of a resin material that is self-sealing upon penetration of the infusion needle 1403. Thus, the lubricating device can be replenished with lubricating fluid through the resin wall portion 1419a during subcutaneous implantation.

[053] Another wall portion 1419b is rigid to provide some stability to the individual components contained within the housing 1418. A window region 1420 is formed on the rigid wall portion 1419b, and a permeable membrane 1421 is sealed into the window region 1420. The permeable membrane 1421 is made of a material that is self-sealing against penetrations caused by the infusion needle 1403, said needle being configured to penetrate the window area 1420 and thereby penetrate the lubricated joint space. The needle 1403 is connected to a piston 1414 separating a first chamber 1415a in front of the piston 1414 from a second chamber 1415b behind the piston 1414 as described above and FIG. 2B. Also provided is a return spring 1411 and a spherical valve 1412 with a return spring 1413. Openings 1422 are provided to connect the second chamber 1415b to the reservoir R such that when the pressure in the first chamber 1415a increases, the piston 1414 can push lubricating fluid out of the second chamber 1415b through the openings. 1422 into tank R, which is under pressure close to atmospheric.

[054] The pressure in the first chamber 1415a is increased by a pump P comprising a movable/flexible wall 1410 moved back and forth by a suitable drive mechanism, motor or the like. Housing 1424, in which piston 1410 is movably configured, defines a flow path 1423. The flow path has a current limit 1425 and an outlet 1426 within housing 1424. The infusion device of FIG. 2C works as follows. When the movable/flexible wall 1410 is activated (i.e., moved in the direction indicated by the arrow), the lubricating fluid contained in the first chamber 1415a will not flow back into the reservoir R through the current path 1423 due to the current limiting 1425 in the current path 1423; instead, the piston 1412 with the needle 1403 is forced to move toward the window area 1420, pushing the lubricating fluid from the second chamber 1415b through the holes 1422 into the reservoir R. When the piston 1412 is in its final position, the movable/flexible wall 1410 moves further into in the direction indicated by the arrow, the pressure in the first chamber 1415a gradually rises to a level sufficient to overcome the spring force of the return spring 1413, which opens the spherical valve 1412 and allows the release of lubricating fluid through the hollow needle 1403, the tip 1408 of which simultaneously penetrates the membrane 1418 and a joint in which the lubricating device body 1418 is suitably located. After the pressure in the first chamber 1415a is reduced due to the posterior sliding of the movable/flexible wall 1410, the spherical valve 1412 is immediately closed 1412, and the piston 1412 with the infusion needle 1403 is simultaneously pulled back to the retracted position. The flow path 1423 is necessary to allow the movable/flexible wall 1410 to further move rearwardly after the piston 1412 has reached its initial position, thereby allowing additional lubricating fluid to be drawn from the reservoir R into the first chamber 1415a, said additional lubricating fluid compensating for the amount of lubricating fluid fluid delivered to the patient during periodic cycles of administration. In addition to allowing the driving mechanism D to be inserted and withdrawn from time to time, the lubricating device drive mechanism of FIG. 2C may also include means for laterally moving the tip 1408 of the infusion needle 1403 to prevent fibrosis or the like.

[055] The lubrication device of FIG. 2C provides a number of advantages, such as the absence of any gas chambers and the absence of the need to seal the movable/flexible wall 1410 and piston element 1412. It should be noted that all components of the infusion device of FIG. 2B may be made of a polymeric material, but preferably at least the infusion needle 1403 and the return springs 1411, 1413 are made of an inert metal. In fig. 2D is a cross-sectional view of a pump-motor assembly that may be used in the arrangement shown in FIG. 1F. This pump-motor unit is described in detail in WO 2004/012806 A1, and other pump units disclosed in the present description can also be used in accordance with the present invention. The pump-motor assembly includes a valve pump assembly, wherein a diaphragm pump P and a valve pump assembly 1434 are the two main elements of the assembly mounted in a cylindrical housing 1435. The valve assembly 1434 includes a first valve in the form of a ceramic disk 1436, fixedly mounted on the housing 1435 and attached thereto, and a second valve in the form of a ceramic disk 1437 facing towards, in contact with, and rotatable relative to the fixed disk 1436. The motor 1438 is mounted on a housing 1435, enclosing the ceramic discs 1436 and 1437. The motor 1438 includes a grooved shaft motor, associated with corresponding grooves in the lower central hole in the rotary disk 1437, which allows the disk 1437 to move in a substantially axial direction relative to the motor shaft 1439 despite the fact that the disk 1437 rotates with the motor 1435. A locking element 1440 is installed on the motor shaft 1439 and a spring washer 1441 exerting slight pressure on the disk 1437, pressing it against the stationary disk 1436.

[056] Pump P includes a pump membrane 1451, which can be any kind of membrane. Preferably, the membrane 1451 is a metal membrane, such as a titanium membrane, or a membrane made of a coated plastic material to provide long service life and prevent liquid diffusion through the membrane 1451 over time. The operating device, in this embodiment built into the valve pump assembly, includes a cam clutch 1452 that has a groove with two opposing cam surfaces 1453, a cam gear 1454 that rotates in the groove to press against the cam surfaces 1453, and a pump shaft 1455 connected to a rotary disk. 1437. The cam gear 1454 is mounted on the pump shaft 1455 by means of a cam gear shaft 1456. Rotation of the pump shaft 1455 occurs due to its connection to the rotary disk 1437 by means of a grooved shaft 1461 associated with corresponding grooves in the upper central hole 1461 in the rotary disk 1437. The above-described grooved connection allows movement of the disk 1437 in a substantially axial direction relative to the pump shaft 1455. The pump shaft 1455 is mounted in a sealed ball bearing 1458 and is axially stationary relative to the ball bearing 1458. A plurality of elongated grooves 1459 on the pump shaft 1455 extend beyond the ball bearing 1458 and serve as fluid flow paths between the first channel 1442 of the stationary disk 1436 and the pump chamber 1460 below the diaphragm. 1451.

[057] As the motor 1438 turns, the diaphragm 1451 moves up and down. As the membrane 1451 moves up and down, a rotary disk 1437 connects the first channel 1442 alternately with the second and third channels 1444 and 1445 such that liquid moves from the second channel 1444 or the third channel 1445 into the pump chamber 1460 or moves from the pump chamber 1456 into a second channel 1444 or a third channel 1445. In FIG. 2D, the first channel 1442 is shown connected to the second channel through an open channel 1450 such that the second channel 1444 receives fluid from the chamber 1460 through the first channel 1442. The choice of material for making the disks 1436 and 1437 is important since it must be able to function at very precise stability values so that the disks do not stick to each other over time. There are a number of materials available that are suitable for this purpose, such as ceramic or ceramic mixed with other materials such as carbon fibre.

In fig. 3 shows a medical device according to an embodiment, wherein the medical device is configured to replace the contact surface of a human femoral head. In the medical device according to this embodiment, the artificial contact surface 1103b of the medical device includes multiple channels configured to lubricate the human hip joint with a lubricating fluid. The medical device also includes an attachment portion 44 for attaching the medical device to the femoral head and/or femoral neck.

[058] In FIG. 4 shows the medical device of FIG. 3 is a cross-sectional view comprising a plurality of passages positioned in fluid connection to a reservoir (not shown) via a passage 1106 centrally located on the mounting portion 44, the passages 1105 being fully integrated into the medical device. Channel 1106 carries lubricating fluid to inlet 1123 for further distribution through channels 1105. The channel ends in a connecting portion 1111 configured to connect the channel to a second channel 1106, a reservoir, or additional channels.

In fig. 5 is a front view of the human body and illustrates a laparoscopic/arthroscopic method of hip surgery for performing a medical device according to any of the embodiments disclosed herein from the reverse side of the acetabulum 8. The hip joint includes an acetabulum 8 and a femoral head 5. Small incisions 14 in the human abdominal wall allow laparoscopic/arthroscopic trocars 33 a,b,c to be inserted into the body of patients. Then, through said laparoscopic/arthroscopic trocars 33 a,b,c, at least one of the following elements can be introduced into the patient's body: a chamber 34, a surgical instrument configured to make an opening in the pelvic bone 35, or instruments 36 for insertion, placement , connecting, attaching, forming or filling an implantable medical device.

[059] In FIG. 6 shows a side view of the human body, with the hip joint shown in section. The hip joint contains a femoral head 5 located on the uppermost part of the femoral neck 6, which is the upper part of the femur 7. The femoral head 5 is connected to the acetabulum 8, which is the cup-shaped part of the pelvic bone 9. Laparoscopic/arthroscopic trocars 33 a,b,c are used to reach the hip joint 39 with at least one of the following components: a camera 34, a surgical instrument 35 configured to make an opening in the pelvic bone 9, or instruments 36 for insertion, placement, connection, attachment, formation, or filling of an implantable medical device.

In fig. 7 shows the process of making a hole 18 in the pelvic bone 9 after cutting the pelvic bone 9. The hole 18 is made on the abdominal side of the pelvic bone 9 by repeated or sequential movement of the hole-forming device 22, located in the human body on the abdominal side of the pelvic bone 9. The opening 18 extends into the hip joint 19 through the pelvic bone 9 on the reverse side of the acetabulum 8. According to the first embodiment, the opening 18 is large, allowing the implantable medical device to pass through the opening 18 at its full functional size.

[060] In FIG. 8a shows a second embodiment in which the surgical or laparoscopic/arthroscopic opening 20 is significantly smaller, as shown in FIG. 8a, whereby a hole-forming device 22 can be used to make a smaller opening 20, which also reduces the cutting and dissection performed on the human body.

In fig. 8b shows a sectional view of the hip joint when the medical device is placed between the femoral head 5 and the acetabulum. The medical device according to this embodiment includes channels 1105 connected to the channel 1106, which in turn is connected to a connecting part located in the hole in the pelvic bone 9. The channel 1106 carries the lubricating fluid to the inlet 1123 for further distribution through the channels 1105. For introduction through the hole 18 in the pelvic bone 9 and smaller in size than a medical device, the latter can be rolled or compressed or, according to another embodiment, molded in an area or in a form capable of being absorbed by the human body, melting, or serving as the surface of a medical device. The medical device may be configured to be secured by means of an adhesive or a mechanical fastener.

[061] In FIG. 9a shows a sectional view of the hip joint when the medical device is placed through the opening 18 in the pelvic bone 9 to replace the contact surface of the femoral head 5. The medical device includes an artificial contact surface 1103b and an attachment portion 44 centrally located in the medical device and configured to attach the medical device to the femoral head 5. The medical device includes multiple channels 1105 located on the artificial contact surface to lubricate the hip joint. The channels are in fluid connection to channel 1106, which in turn is connected to a connecting portion 1111b configured to connect the channel to a second channel 1106b or a second channel portion 1106b, which in turn is in fluid connection to a reservoir 1108. placed in the femur 7 of a person. A reservoir 1108 is located in the femur 7 and is configured to hold a lubricating fluid under pressure, according to the embodiment of FIG. 9a exerted by said reservoir 1108 spring-loaded by a spring 1109 connected to a movable wall portion in the form of a piston 1110 compressing the lubricating fluid. The reservoir 1108 is also connected to an inlet 1107 located in connection with the femur 7 below the greater trochanter 1186, but other suitable placements in connection with the bone, in a cavity or subcutaneously are possible. The medical device according to the embodiment of FIG. 9a is configured to operate using a pressure reservoir, however, in other embodiments, the medical device is configured to operate using a powered operating device, such as an implantable pump, which may be driven by direct thrust, such as inductive or magnetic propulsion, or through a rechargeable energy source such as a battery. The channels, according to one embodiment (not shown), may include a valve to close the flow of lubricating fluid through channel 1106 or channel 1105, thereby closing the connection between the reservoir and the artificial contact surface. The valve can be equipped with a drive and the ability to control it from outside the human body through, for example, remote control.

[062] In FIG. 9b is a cross-sectional view of a hip joint where a medical device according to yet another embodiment is formed into the hip joint, replacing the contact surface of the femoral head. The medical device includes an artificial contact surface 1103b containing a plurality of channels 1105 connected to a channel 1106, 1106b located in the fastening portion of the medical device. The channel is in turn in fluid connection with a reservoir 1108 located within the femur, preferably in the cancellous portions of the femur, and the reservoir is in fluid connection with the medical device channels for lubricating the artificial contact surface 1103b of the medical device.

In fig. 10 shows a cross-section of the hip joint when the implantable medical device is configured to replace the contact surface of the acetabulum. The medical device includes an artificial acetabular surface 65 containing multiple channels connected to the channel 1106 via a connecting portion 1111. The medical device according to the embodiment of FIG. 10 is configured to fit into an opening 18 in the pelvic bone to replace the acetabulum contact surface 65. In fig. 10 also shows a block to which a passage 1106 is connected; in one embodiment, the block includes a reservoir 1108 and two pumping devices 1113a, 1113b configured to generate pressure to compress a lubricating fluid to force said lubricating fluid through the passage 1106 and beyond. through multiple passages 1105 to lubricate the implantable medical device. The channel 1106 carries the lubricating fluid to the inlet 1123 for further distribution through the channels 1105. The pumping devices may be spring-loaded or may consist of an element filled with compressed gas, which is further compressed due to the introduction of the lubricating fluid into the reservoir 1108. The block also includes an inlet channel. 1107 comprising a self-sealing membrane 1112, which is preferably a parylene-coated silicone membrane. According to another embodiment, the unit includes a driven operating device, such as a pump, located in a container 1113a and pumping lubricating fluid from the reservoir 1108 through a channel 1106 into a plurality of channels 1105. In one embodiment, the pump is driven by a battery located in department 1113b.

[063] In FIG. 11a shows a surgical instrument configured to receive a medical device according to any of the embodiments disclosed herein, or a mold for forming a medical device according to a first embodiment. The surgical instrument includes a gripping portion 76 and a working portion 77. According to the embodiments shown in FIGS. 11 a,b,c, the tool additionally includes a rotating element 78, which allows the gripping part 76 to rotate relative to the working part 77, but it is possible to make a surgical instrument that is not equipped with the specified rotating element 78.

In fig. 11b shows a surgical instrument configured to insert a prosthesis, prosthetic parts, or parts necessary to form or form a hip joint surface according to a second embodiment. According to this embodiment, the surgical instrument additionally contains a parallel sliding part 79, which allows to increase the reach of the instrument and facilitate the process of reaching the hip joint through the hole in the pelvic bone on the opposite side of the acetabulum 8.

[064] In FIG. 11c shows a surgical instrument configured to insert a prosthesis, prosthetic parts, or parts necessary to form or form a hip joint surface according to a third embodiment. According to this embodiment, the surgical instrument further includes two angle adjustment members 80a,b. The angle adjustment elements may be adjusted to change the angle of said gripping portion 76 relative to the working portion 77, or secured at an angle suitable for operating in the hip joint through an opening in the pelvic bone on the opposite side of the acetabulum 8.

In fig. Figure 12 shows a cross-section of the hip joint with a medical device placed. The implantable medical device is configured to replace the surface of the acetabulum and is inserted through an opening 18 in the pelvic bone 9, but in other embodiments the medical device may be configured to be inserted through an opening in the femur 7 or hip capsule. The medical device includes multiple channels 1105 connected to each other through a channel 1106 providing fluid connection of the channels 1105 to each other. The channel 1106 carries the lubricating fluid to the inlet 1123 for further distribution through the channels 1105. The channel 1106 is also connected to the first part of the connecting part 1111, configured to connect with the second part of the connecting part 1111b. The connecting part 1111 connects the first part of the channel 1106 with the second part of the channel 1106, which allows the first part of the channel 1106 to be inserted from the acetabulum side of the pelvic bone 9, and the second part of the channel 1106 to be inserted from the pelvic side or from the side opposite the acetabulum of the pelvic bone 9. The connection of the two portions of the channel 1106 is particularly advantageous when the medical device is inserted through the opening 18 in the femur 7 or hip joint capsule and the reservoir 1108 is implanted in the abdomen of a person or other area on the ventral side of the pelvic bone 9. The channel 1106 is then also connected to the reservoir 1108 and configured to transfer lubricating fluid from the reservoir 1108 to the hip joint region. The reservoir 1108 according to the embodiment of FIG. 12 is configured to place lubricating fluid under pressure by means of a spring 1109 exerting a force on the movable wall portion in the form of a piston 1110 forcing the lubricating fluid through channel 1106 and then through channels 1105. Reservoir 1108 further includes an inlet channel 1107 located at the top. reservoir 1108 to replenish reservoir 1108 and concomitantly increase the pressure of the lubricating fluid.

[065] In FIG. 13a is a side view of a person with the hip joint shown in section. The femur 7 has a proximal portion comprising a femoral neck 6 and, at the most proximal portion, a femoral head 5. In fig. 13a, an opening 82 is made through an incision made in the femur, the opening extending into the femur 7, along the femoral neck 6 and exiting through the femoral head 5 into the hip joint. The opening is used to accommodate a medical device in the hip joint, which can preferably be rolled or bent for insertion through said opening 82.

In fig. 13b is a cross-sectional view of a hip joint with a medical device placed through an opening 82 in the pelvic bone 7 and secured in the acetabulum 8. The medical device includes multiple channels 1105 connected to each other through a channel 1106. In other embodiments, the medical device may be placed through the capsule of the hip joint or through an opening in the 9th pelvic bone. Once the medical device has been positioned, a tool 1180 housing a reservoir 1108 coupled to a channel 1106' is used to position the reservoir 1108 in the opening 82 in the femur 7 and to connect the reservoir to the channel 1106 of the medical device.

[066] In FIG. 13c is a cross-sectional view of a hip joint with a reservoir 1108 located in an opening 82 in the femur 7 and connected to a medical device. A passage 1106' is also provided extending from the reservoir 1108 to the inlet passage 1107 to replenish and/or compress the reservoir 1108.

In fig. 13d the reservoir block is shown in more detail; the reservoir block includes a connecting portion 1111 disposed on an end portion of the reservoir block, a compressed reservoir 1108, according to the embodiment of FIG. 13d, compressed by a spring 1109 pushing the movable wall portion 1110 in the form of a piston 1110. The reservoir unit further includes a channel 1106' connected to the reservoir and with an inlet passage 1107 for filling and/or compressing a reservoir 1108 containing a lubricating fluid. The inlet 1107 includes a self-sealing membrane, which may be a parylene-coated self-sealing silicone membrane, to limit cell migration on the surface of the inlet. The cross-section along line A-A shows a centrally located channel 1106 in the center of the reservoir 1108 for filling and/or compressing the reservoir 1108.

[067] In FIG. 14 is a cross-sectional side view of a person introducing lubricating fluid into the inlet passage 1107 through an introduction member 92 including a container 1115 configured to contain the introduced lubricating fluid. The inlet channel is connected to the implantable medical device located in the hip joint through a channel 1106 configured to provide a fluid connection between the inlet channel and the medical device. The medical device in turn contains several channels 1105 for lubricating the artificial contact surfaces, and accordingly, lubricating the hip joint. According to the embodiment shown in FIG. 14, the medical device is supplied from the ventral side of the pelvic bone 9 through an opening made in the pelvic bone, and subsequently filled with a removed bone filling, sealed and secured by a mechanical fastening part attached by screws. According to other embodiments, the medical device is placed on the hip joint side of the pelvic bone 9 through the hip joint capsule 12 or femur bone 7, and then connected to the channel 1106 on the ventral side of the pelvic bone 9 via a connecting portion 1111. This allows the inlet channel 1107 to be placed in the abdominal cavity, subcutaneously, in a cavity and/or supported by muscle or fascial tissue.

[068] In FIG. 15 shows an opposite embodiment of a medical device comprising a first artificial contact surface 112 having a convex shape towards the center of the hip joint. The first artificial contact surface 112 is configured to be attached to the human pelvic bone 9. The convex artificial surface 112 of the hip joint is configured to be attached to the pelvic bone 9 and inserted through an opening 18 into the pelvic bone 9. The medical device includes a nut 120 threaded for tightly attaching the medical device to the pelvic bone 9. The medical device further includes a prosthetic part 118 configured to be placed in an opening 18 provided in the pelvic bone 9 after the medical device is implanted into the patient. The prosthetic portion 118 includes load-bearing members 119 configured to contact the pelvic bone 9 and assist in bearing the load imposed on the medical device by the weight of a person during normal use. Normal use refers to use identical to human use of a natural hip joint. In addition, the medical device includes a locking element 116 including a surface 117 configured to contact a convex artificial surface 112 of the hip joint. The locking element 116 further includes locking elements 115 configured to facilitate attachment of the locking element 116 to the head 5 or neck 6 of the femur, which in turn secures the convex artificial surface 112 of the hip joint. The convex artificial hip joint surface 112 is attached to a mounting rod 113 provided with threads 114 corresponding to the threads of a nut 120 coupled to the prosthetic portion 118. The medical device includes multiple channels 1105 configured to lubricate the artificial contact surface 112. The multiple channels 1105 are connected to each other. through a channel 1106 configured to transfer lubricating fluid from a reservoir 1108 to a plurality of channels 1105 fully integrated into the artificial contact surface 112 of the medical device to lubricate the artificial contact surface 112, and accordingly, lubricate the hip joint.

[069] In FIG. 16 shows the medical device of FIG. 15, placed inside the hip joint. A first artificial contact surface having a convex shape towards the center of the hip joint is housed in a second artificial contact surface 109 having a concave shape towards the center of the hip joint. A second artificial contact surface 109 is located and secured in the femoral head 5 and neck 6, and is secured by a locking member 116 comprising a surface 117 facing the first convex artificial contact surface 112. The medical device includes a plurality of channels 1105 connected to a channel 1106 located in the medical device centrally, to provide the medical device with a lubricating fluid and to lubricate the artificial contact surface 112, and thus the hip joint.

In fig. 17 shows the process of placing the prosthetic part 118 in the hole 18 in the pelvic bone 9. The prosthetic portion 118 includes load-bearing members 119 configured to contact the pelvic bone 9 and help bear the load imposed on the medical device by the weight of a patient during normal use.

[070] In FIG. 18 shows an embodiment of a medical device according to the opposite embodiment, in which a portion of the medical device comprising a concave artificial hip surface located in the head 5 and neck 6 of the femur includes a plurality of lubricant passages 1105 connected to the passage 1106b, establishing a fluid connection between the medical device and the reservoir located in the cancellous bone of the femoral neck 6. The reservoir is configured to be refilled through an inlet port 1107, which according to the embodiment of FIG. 18 is positioned in conjunction with the femur 7 and located below the greater trochanter 1186. The reservoir assembly and its operation are described in more detail with reference to FIG. 9a and 9b. In fig. 18 also shows the prosthetic portion 118 attached to the pelvic bone 9 by screws 121. Instead of or in addition to the screws, an adhesive may be used in conjunction with the screws or on the surface S between the prosthetic portion and the pelvic bone 9.

In fig. Figure 19 shows the right leg of a person. A femur having a distal portion comprising a lateral condyle 105, a medial condyle 106, and a region between said lateral and medial condyles. The portions of the distal femur 102 comprise the knee joint contact surfaces. The knee joint also includes a patella 101, which is a triangular bone articulated with the femur 102 and covering and protecting the knee joint. The knee joint also contains menisci 107, 108, which are cartilaginous elements within the knee joint that serve as articulating surfaces to protect the ends of the bones from rubbing against each other. Menisci 107, 108 also act as shock absorbers of the knee joint to absorb shocks that occur when a person moves. In each knee there are two menisci 107,108 - the medial meniscus 107 and the lateral meniscus 108. In patients suffering from osteoarthritis, the menisci 107, 108 act as articulating surfaces, i.e. load-bearing surfaces wear out and, in severe cases, bone in the joint may be exposed. The knee joint is protected by the knee capsule, also known as the knee capsule or patellar ligament. The knee joint capsule is wide and weak; thin at the front and sides and contains the patella 101, ligaments, menisci 107,108 and bursae, which are small fluid-filled bags of white fibrous tissue. The knee joint capsule consists of synovium and a fibrous membrane separated by fatty deposits anteriorly and posteriorly.

[071] In FIG. 20 shows a knee joint with artificial knee joint surfaces 130, 116a placed on the distal portion of the femur 102 and the proximal portion of the tibia 104. The lateral and medial channels 125a,b supply the contact surfaces, and accordingly, the knee joint with lubricating fluid for the purpose of reducing friction of the knee joint.

In fig. 21 is a front view of a human body where the reservoir unit 127 is implanted subcutaneously into the human abdomen. The reservoir assembly of this embodiment includes an operating device in the form of a pump 130 driven by a battery 128 to pump fluid from the reservoir 129 through a channel into a channel 125 supplying the artificial knee joint surfaces with lubricating fluid. The reservoir block is attached to the muscle tissue or fascia 1181 of the abdominal wall by sandwiching the muscle tissue or fascia 1181 between the reservoir block and an inlet channel 1107 formed on the outside of the muscle tissue or fascia 1181.

In fig. 22a shows an embodiment in which the medical device includes an artificial knee joint surface 115 that clamps the medial, lateral, or medial and lateral condyles 106 of the knee joint representing the distal portion of the femur 7. The medical device according to this embodiment includes multiple channels 1105 for lubricating the artificial contact surfaces, said channels are in fluid communication with each other via a channel 1106, which in turn is in fluid connection with a reservoir 1108 containing an inlet channel 1107 for replenishing the reservoir or compressing the lubricating fluid contained in the specified reservoir 1108. Channel 1106 carries lubricating fluid to inlet 1123 for further distribution through channels 1105.

[072] In FIG. 22b shows a side view of a knee joint with a medical device comprising an artificial contact surface 1102 placed on the proximal portion of the tibia 104, together with the fibula 103 forming the lower leg. The artificial knee surface includes a plurality of channels 1105 in fluid communication with a channel 1106 configured to transfer lubricating fluid from a reservoir 1108. The reservoir 1108 according to the embodiment of FIG. 22b is located on the back side of the tibia 104 and attached to the tibia 104, and includes an inlet channel 1107 for introducing lubricating fluid into the reservoir 1108 and/or for compressing the lubricating fluid contained in the reservoir 1108. The channel 1106 carries the lubricating fluid to the inlet 1123 for further distribution through channels 1105.

In fig. Figure 23 shows a medical device for implantation in the knee joint in more detail. The medical device includes multiple channels 1105 located along the artificial contact surface of the medical device for lubricating the contact surface of the medical device. Channels 1105 are connected to channel 1106 for transporting lubricating fluid along the artificial contact surface 1101 of the medical device. Channel 1106 carries lubricating fluid to inlet ports 1123 for further distribution through channels 1105.

[073] In FIG. 24 is a cross-sectional side view of a medical device in which channels 1105, fully embedded in the artificial contact surface and connected to each other, channel 1106 supplies lubricating fluid to the channels 1105 to lubricate the artificial contact surface of the medical device. Channel 1106 carries lubricating fluid to inlet 1123 for further distribution through channels 1105.

In fig. 25a shows a medical device for implantation in a human knee joint, comprising multiple medical device parts 119 configured to be coupled to each other and to a portion of a medical device base 118 through mechanical locking elements 120 to conform the shape of the multiple medical device parts 119 to the base portion 118 The medical device base portion 118 also includes an attachment portion 117 configured to provide mechanical attachment of the medical device to a human bone, such as the proximal portion of the tibia. The medical device body portion 118 further includes a passage for supplying a lubricating fluid to the artificial knee joint contact surface.

In fig. 25b shows a medical device according to FIG. 25a assembled.

In fig. 26 shows a medical device according to FIG. 25a and 25b, attached to the tibia 104.

[074] In FIG. 27 shows a proximal portion of the tibia 104, with a medical device including an artificial contact surface 116 attached to the tibia 104. An artificial contact surface channel 1105 is connected to a channel 1106 providing a fluid connection between the medical device channel 1105 and the first and second reservoirs 1108 located inside the tibia 1104 on the medial and lateral side. The channel also connects the first and second reservoirs to an inlet channel 1107 located on the medial side of the pelvic bone to replenish and/or compress the reservoirs 1108. The reservoirs 1108 according to the embodiment shown in FIG. 27 are configured to place the lubricating fluid under pressure, causing the lubricating fluid to be pushed out of the channels 1105 onto the artificial lubricating surface to lubricate the knee joint. To this end, the reservoir 1108 includes a spring 1109 coupled to a movable wall portion in the form of a piston 1110 for compressing the lubricating fluid.

In fig. 28 is a front view of a person with an implanted lubrication system 120. The implanted lubrication system 120 is configured to continuously, intermittently, or inject a lubricating fluid into the hip joint as needed. According to the embodiment shown in FIG. 61, the implantable lubrication system contains two interconnected blocks 121, 122. The two connected blocks are located in the abdominal cavity of a person and are connected to the hip joint through a channel 1106.

[075] In FIG. 29 illustrates in more detail an implantable lubrication system 120 that may be used in combination with any of the medical devices disclosed herein. According to the illustrated embodiments, the implantable lubrication system includes a first block 121 comprising a pump element 123 configured to pump a lubricating fluid from a reservoir 1108 to a hip region. The first block 121 also includes an inlet passage 1107 for filling the reservoir 1108 from outside the human body without the need for a surgical procedure. The inlet channel 1107 contains a self-sealing membrane permeable by a needle attached to the syringe. The first block 121 further includes a wireless power receiver 124, preferably including a coil. This wireless power receiver is used to charge the battery 126. According to this embodiment, the implantable lubrication system 120 further includes a second unit 122, which in turn contains a battery 126 and a fluid reservoir 1108. The lubricating fluid 128 is pumped from the reservoir 1108 through the first block 121 by means of a pumping device, through the channel 1106 and into the hip joint region, where it helps to lubricate the hip joint surfaces or artificial contact surfaces of the implantable medical device. The lubricating fluid is preferably a biocompatible lubricating fluid such as hyaluronic acid.

In fig. 30 illustrates an implantable lubrication system configured for use with any medical device disclosed herein, according to an embodiment wherein the implantable lubrication system is a circulatory lubrication system comprising one inlet 130 at a lubricated joint and one outlet 131. Preferably, the system is a continuous lubrication system in which the pump element 123 continuously circulates the lubricating fluid 128 within the hip joint.

[076] In FIG. 31 illustrates an implantable lubrication system for circulatory lubrication configured for use with any medical device disclosed herein, the lubrication system further comprising a filter element 132 for filtering the lubricating fluid. The filter is self-cleaning and the filtered material is discharged through an outlet channel 133 into the human abdomen or into a container attached to the outlet channel 133. By filtering the lubricating fluid 128, the circulatory lubrication system can operate for extended periods of time without the need for any surgical procedures. procedures.

In fig. 32 shows the lubricating fluid of FIG. 29 when lubricating an implantable medical device comprising an artificial contact surface 45 with a lubricating fluid 128.

In fig. 33 illustrates a lubrication system that may be configured for use in combination with any medical device disclosed herein, according to yet another embodiment, wherein the lubrication system includes a block 1310 containing a diverter needle 1311 attached to an operating system for operating said diverter needle 1311. The needle is configured to penetrate a self-sealing membrane 1314 located in the pelvic bone 9 to introduce a lubricating fluid into the hip joint. The channel 1106 is configured to supply a lubricating fluid from the inlet channel and/or from an additional reservoir, which can be implanted subcutaneously or in a body cavity, into the block 1310.

[077] In FIG. 33b shows the lubrication system in a position in which the diverter needle 1311 is advanced by the operating device for operating the diverter needle 1311. The needle then penetrates the self-sealing membrane 1314 and is in a position in which lubricating fluid can be introduced. In fig. 34 shows a system for treating a disease comprising a device 10 of the present invention located in the abdominal cavity of a patient. The implanted energy conversion device 1002 is configured to supply energy to energy-consuming components of the installation via a power supply line 1003. The external power transmission device 1004 for non-invasively providing energy to the installation 10 transmits energy through at least one wireless energy signal. The implanted power conversion device 1002 converts power from the wireless power signal into electrical power supplied via the power line 1003 .

The implanted energy conversion device 1002 may also include other components such as: a coil for receiving and/or transmitting signals and energy, an antenna for receiving and/or transmitting signals, a microcontroller, a charge control unit optionally containing an energy storage device such as a capacitor , at least one sensor such as a temperature sensor, a pressure sensor, a position sensor, a motion sensor, etc., a transceiver, a motor, optionally comprising a motor controller, a pump and other parts for controlling the operation of the medical implant.

[078] The wireless energy signal may comprise a wave signal selected from the following group: an audio wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal , RF signal, X-ray signal, and gamma ray signal. In another embodiment, the wireless energy signal may comprise an electric or magnetic field or a combined electric and magnetic field.

The wireless power transmission device 1004 may transmit a carrier signal for carrying a wireless power signal. Such a carrier signal may comprise digital, analog, or a combination of digital or analog signals. Here, the wireless energy signal comprises an analog or digital signal or a combination of an analog and digital signal.

In general, the power conversion device 1002 is configured to convert a first form of wireless energy transmitted by the power transmission device 1004 into a second form of energy, which is typically different from the first form of energy. The implanted unit 10 can operate under the influence of the second form of energy. The power conversion device 1002 may directly provide power to the installation in the form of a second form of energy as the first form of energy transmitted by the power transfer device 1004 is converted into a second form of energy by the power conversion device 1002. The system may also include an implantable battery, wherein a second form of energy is used to at least partially charge the battery.

[079] In another embodiment, the wireless power transmitted by the power transmission device 1004 may be used to directly power the installation as the wireless power is transmitted by the power transmission device 1004. In case the system includes an operating device for operating an installation, as described below, the wireless energy transmitted by the power transmission device 1004 can be used to directly power the operating device to generate kinetic energy for operating the installation.

The first form of wireless energy may comprise sound waves, and the energy conversion device 1002 may include a piezoelectric element for converting sound waves into electrical energy. The second form of energy may comprise electrical energy in the form of direct current or pulsating direct current, or a combination of direct current and pulsating direct current, or alternating current, or a combination of direct and alternating current. Typically the installation contains electrical components powered by electrical energy. Other implantable electrical components of the system may be at least one voltage level protective device and/or at least one DC protective device coupled to the electrical components of the installation.

[080] Optionally, one of the energy of the first form and the second form may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy or thermal energy. Preferably, one of the energy of the first form and the second form is non-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy transfer device can be controlled from outside the patient's body to release electromagnetic wireless energy that is used to operate the device. In another embodiment, the energy transfer device is controlled from outside the patient's body to produce non-magnetic wireless energy that is used to operate the device.

The external power transmission device 1004 also includes a wireless remote control having an external signal transmitter for transmitting a wireless control signal for non-invasive control of the installation. An implanted signal receiver, which may be integrated into or separate from the implanted energy conversion device 1002, receives the control signal.

[081] The wireless control signal may comprise a frequency modulated signal, amplitude modulated signal, phase modulated signal, or a combination thereof. In another embodiment, the wireless control signal comprises an analog or digital signal or a combination of an analog and digital signal. In another embodiment, the wireless control signal comprises an electric or magnetic field or a combined electric and magnetic field.

The wireless remote control can transmit a carrier signal to carry a wireless control signal. Such a carrier signal may comprise digital, analog, or a combination of digital or analog signals. If the control signal contains an analog or digital signal or a combination of an analog and digital signal, the wireless remote control preferably transmits an electromagnetic carrier wave signal to carry the digital or analog control signal.

In fig. 35 shows the system of FIG. 34 is a more general block diagram showing the apparatus 10, an apparatus 1002 for powering the apparatus 10 via a power supply line 1003, and an external apparatus 1004 for transmitting power. The patient's skin 1005, shown generally as a vertical line, separates internal components within the patient to the right of the line from external components to the left of the line.

[082] In FIG. 36 shows an embodiment of the invention identical to the embodiment shown in FIG. 35 except that a reversing device in the form of an electrical switch 1006 operating, for example, on polarized energy is further implanted in the patient to reverse the setting 10. When the switch is operated on polarized energy, the wireless remote control of the external energy transfer device 1004 transmits a wireless signal , carrying polarized energy, and the implanted power conversion device 1002 converts the wireless polarized energy into a polarized current to operate the electrical switch 1006. When the polarity of the current is shifted by the implanted power conversion device 1002, the electrical switch 1006 reverses the function performed by the installation 10.

In fig. 37 shows an embodiment of the invention identical to the embodiment shown in FIG. 35 except that the operating device 1007 implanted in the patient to operate the unit 10 is placed between the implanted energy conversion device 1002 and the unit 10. The operating device may be a motor 1007 such as an electric servo motor. The motor 1007 is powered by energy received from the implanted power conversion device 1002 as the remote control transmits the wireless signal energy from the external device 1004 to the receiver of the implanted power conversion device 1002.

[083] In FIG. 38 shows an embodiment of the invention identical to the embodiment shown in FIG. 35 except that it also includes an operating device implanted into the patient in the form of an assembly 1008 containing a motor/pump assembly 1009 and a fluid reservoir 1010. In this case, installation 10 operates hydraulically, i.e. hydraulic fluid is pumped through the motor/pump unit 1009 from the fluid reservoir 1010 through the passage 1011 to the unit 10 to operate the unit 10, and to return the unit to its original position, the hydraulic fluid is pumped back through the motor/pump unit 1009 from the unit 10 to reservoir 1010 for fluid. The implanted power conversion device 1002 converts wireless energy into current, such as polarized current, to power the motor/pump unit 1009 via power supply line 1012. Instead of a hydraulically driven installation 10, it is also provided that the operating device comprises a pneumatic operating device. In this case, the hydraulic fluid may be compressed air used for adjustment, and an air chamber is provided instead of a reservoir for the fluid.

In all of the above embodiments, the power conversion device 1002 may include a rechargeable accumulator, such as a battery or capacitor, that is charged wirelessly and supplies power to any power consuming part of the system.

In yet another embodiment, the wireless remote control described above may be replaced by manual control of any implanted part to contact the patient's arm, most likely indirectly, for example, through a push button located under the skin.

[084] In FIG. 39 shows an embodiment of the invention comprising an external wireless remote controlled power transfer device 1004, a hydraulically operated unit 10, and an implanted power conversion device 1002, and also comprising a hydraulic fluid reservoir 1013, a motor/pump assembly 1009 and a reversing device in the form of a hydraulic valve shifting device 1014, all of which are implanted in the patient. Naturally, hydraulic work can be easily accomplished by simply changing the direction of pumping, and thus the hydraulic valve need not be used. The remote control may be a device separate from or incorporated into the external power transmission device. The motor of the motor/pump unit 1009 is an electric motor. Under the influence of a control signal from the wireless remote control of the external power transfer device 1004, the implanted power conversion device 1002 supplies the motor/pump unit 1009 with energy obtained from the energy transferred by the control signal, whereby the motor/pump unit 1009 distributes hydraulic fluid between the reservoir 1013 hydraulic fluid and the installation 10. The remote control of the external power transmission device 1004 controls the hydraulic valve shifting device 1014 to shift the direction of hydraulic fluid flow between one direction in which the fluid is pumped by the motor/pump unit 1009 from the hydraulic fluid reservoir 1013 hydraulic fluid to the unit 10 to operate it, and in the opposite direction in which the fluid is pumped back from the unit 10 by the motor/pump unit 1009 to the hydraulic fluid reservoir 1013 to return the unit to its original position.

[085] In FIG. 40 shows an embodiment of the invention comprising an external power transmission device 1004 with wireless remote control, an installation 10, an implanted power conversion device 1002, an implanted internal control unit 1015 controlled by a wireless remote control of the external power transmission device 1004, an implanted battery 1016, and implanted capacitor 1017. The internal control unit 1015 stores electrical energy received from the implanted power conversion device 1002 in a battery 1016, supplying power to the installation 10. Under the influence of a control signal from the wireless remote control of the external power transmission device 1004, the internal control unit 1015 extracts electrical energy from the battery 1016 and transmits it through transmission lines 1018 and 1019, or directly transmits electrical energy from the implanted energy conversion device 1002 through transmission line 1020, electric current stabilizing capacitor 1017, transmission lines 1021 and 1019 to operate the unit 10 .

The internal control unit is preferably programmable from outside the human body. In a preferred embodiment, the internal control unit is programmed to adjust the setting 10 in accordance with a programmed mode of operation or input from any sensor detecting any possible physical parameter of the patient or any functional parameter of the system.

[086] According to an alternative embodiment, capacitor 1017 in the embodiment of FIG. 40, 10 can be omitted. According to another alternative, the battery 1016 may be omitted in this embodiment.

In fig. 41 shows an embodiment of the invention identical to the embodiment shown in FIG. 35 except that a battery 1022 for supplying power for operating the apparatus 10 and an electrical switch 1023 for switching the operation of the apparatus 10 is also implanted in the patient. The electrical switch 1023 may be controlled by remote control and its operation may be provided by energy supplied by the implanted device 1002 for converting energy to switch from an off mode in which the battery 1022 is not used to an on mode in which the battery 1022 supplies energy for operation. installations 10.

In fig. 42 shows an embodiment of the invention identical to the embodiment shown in FIG. 41 except that the internal control unit 1015, controlled by wireless remote control of the external power transmission device 1004, is also implanted in the patient. Here, the electrical switch 1023 operates from the energy supplied by the implanted device 1002 to convert energy to switch from an off mode, in which the wireless remote control cannot control the indoor control unit 1015 and the battery is not used, to a standby mode, in which the remote control can control the internal control unit 1015 to extract electrical energy from the battery 1022 to operate the unit 10.

[087] In FIG. 43 shows an embodiment of the invention identical to the embodiment shown in FIG. 42 except that battery 1016 is replaced by battery 1022 and the implanted components are otherwise connected. Here, the battery 1016 stores energy from the implanted device 1002 for energy conversion. Under the influence of a control signal from the wireless remote control of the external power transmission device 1004, the internal control unit 1015 controls the electrical switch 1023 to switch from an off mode in which the battery 1016 is not used to an on mode in which the battery 1016 supplies power to operate the unit 10 The battery can be replaced by a capacitor or made in combination with it.

In fig. 44 shows an embodiment of the invention identical to the embodiment shown in FIG. 43, except that the battery 1022 is also implanted in the patient and the implanted components are otherwise connected. Under the influence of a control signal from the wireless remote control of the external power delivery device 1004, the internal control unit 1015 controls the power delivery battery 1016 to operate the electrical switch 1023 to switch from an off mode in which the battery 1022 is not used to an on mode in in which battery 1022 supplies electrical energy to operate unit 10.

In another embodiment, operation of the electrical switch 1023 may be accomplished by power supplied by the battery 1016 to switch from an off mode, in which the wireless remote control cannot control the battery 1022 to supply electrical energy, and is not used, to a standby mode, in which the wireless remote control the control may operate the battery 1022 to supply electrical energy to operate the installation 10.

[088] It should be understood that switch 1023 and all other switches in this application are to be interpreted in the broadest possible sense. This means a transistor, microprocessor control unit, main control unit, application specific integrated circuit, field programmable gate array, digital to analog converter, or any other electronic component or circuit capable of turning power on and off. Preferably, the switch is controlled from outside the body, or alternatively, by an implanted internal control unit.

In fig. 45 shows an embodiment of the invention identical to the embodiment shown in FIG. 41 except that the motor 1007, a mechanical reverser in the form of a gearbox 1024, and an internal control unit 1015 for controlling the gearbox 1024 are also implanted in the patient. The internal control unit 1015 controls the gearbox 1024 to reverse the function performed by the unit 10 (performed mechanically). An even simpler option is to electronically switch the direction of the engine. The gearbox, understood in the broadest sense, may be a servo-driven design that allows the force to operate the device to be saved in favor of a longer operating step.

[089] In FIG. 46 shows an embodiment of the invention identical to the embodiment of FIG. 52, except that the implanted components are connected in a different manner. Thus, in this case, the internal control unit 1015 is powered by the battery 1022, while the battery 1016, preferably a capacitor, operates the electrical switch 1023 to switch to the on mode. When the electrical switch 1023 is in the on mode, the internal control unit 1015 may control the battery 1022 to supply (or not supply) power to operate the unit 10.

In fig. 47 schematically shows possible combinations of implanted device components to achieve different communication capabilities. Essentially, an installation 10, an internal control unit 1015, a motor or pump unit 1009, and an external power transmission device 1004 including an external wireless remote control are provided. As described above, the wireless remote control transmits a control signal received by the indoor control unit 1015, which in turn controls various implanted components of the installation.

A feedback device, preferably comprising a sensor or measurement device 1025, may be implanted in a patient to determine a physical parameter of the patient. The physical parameter may be at least one parameter selected from the group consisting of pressure, volume, diameter, stretch, elongation, extension, translation, flexion, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heartbeat and breathing. The sensor can detect any of the above physical parameters. For example, the sensor may be a pressure or motor activity sensor. In another embodiment, sensor 1025 may be configured to determine a functional parameter. The functional parameter may be related to the transfer of energy to charge the implanted energy source and may comprise at least one parameter selected from the group consisting of; electricity, any electrical parameter, pressure, volume, diameter, stretching, elongation, extension, movement, bending, elasticity, temperature and current.

[090] The feedback data may be sent to the internal control unit or to an external control unit, preferably via the internal control unit. Feedback data can be sent from the body through an energy transmission system or a separate communication system with a receiver and transmitters. An internal control unit 1015 or, alternatively, an external wireless remote control of an external power transmission device 1004 may control the installation 10 under the influence of signals from a sensor 1025. A transceiver may be combined with a sensor 1025 to send information about a detected physical parameter to the external wireless remote control . The wireless remote control may include a signal transmitter or transceiver, and the indoor control unit 1015 may include a signal receiver or transceiver. In another embodiment, the wireless remote control may include a signal receiver or transceiver, and the indoor control unit 1015 may include a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send information or data associated with the unit 10 from inside the patient's body to outside the patient's body.

In the case where the motor/pump unit 1009 and the battery 1022 are implanted to power the motor/pump unit 1099, information related to charging the battery 1022 may be transmitted as feedback data. More precisely, when the battery or accumulator is charged with energy, feedback data related to the specified charging process is sent, and the energy supply is changed accordingly.

[091] In FIG. 48 shows an alternative implementation in which adjustment of the unit 10 is carried out from outside the patient's body. The system 1000 includes a battery 1022 coupled to the unit 10 via a subcutaneous electrical switch 1026. Thus, adjustment of the unit 10 is performed non-invasively by manually pressing the subcutaneous switch, thereby turning the unit 10 on and off. It should be understood that the embodiment shown is simplified and additional components may be added to the system, such as an internal control unit or any other part disclosed herein. Two subcutaneously placed switches can also be used. In the preferred embodiment, one implanted switch sends information to the internal control unit to perform some specified action, and when the patient presses the switch again, the reverse action is performed.

In fig. 49 shows an alternative implementation in which the system 1000 includes a hydraulic fluid reservoir 1013 hydraulically coupled to the installation. Non-invasive adjustment is carried out by manually pressing a hydraulic reservoir connected to the unit. In another embodiment, the hydraulic fluid reservoir 1013 is configured to operate with an inlet port for introducing hydraulic fluid, preferably for the purpose of calibrating it.

[092] The system may include an external data transmitter and an implantable internal data transmitter coupled to the external data transmitter. The internal transmitter supplies device- or patient-related data, the external data transmitter and/or the external data transmitter supplies the internal data transmitter with data.

In fig. 50 schematically illustrates a system arrangement configured to send data from inside a patient's body to outside the patient's body for the purpose of transmitting feedback data associated with at least one functional parameter of the installation or system or associated with a physical parameter of the patient to ensure delivery of an accurate amount of energy to the implanted an internal energy receiver 1002 coupled to implanted energy consuming components of the installation 10. Such energy receiver 1002 may include an energy source and/or energy conversion device. Briefly, wireless power is transmitted from an external power source 1004a located outside the patient and received by an internal power receiver 1002 located inside the patient. The internal power receiver is configured to directly or indirectly supply the energy consuming components of the installation 10 with the received energy through the switch 1026. The energy balance between the energy received by the internal power receiver 1002 and the energy used by the installation 10 is determined, and the wireless energy transmission is further controlled based on the determined energy balance. Thus, the energy balance provides an accurate indication of the required amount of energy, sufficient for proper operation of the installation 10, but not causing an undesirable increase in temperature.

[093] In FIG. 50, the patient's skin is marked by a vertical line 1005. In this embodiment, the energy receiver includes an energy conversion device 1002 located within the patient, preferably just below the patient's skin 1005. In general, the implanted energy conversion device 1002 may be placed in the abdomen, chest, muscular fascia (eg, abdominal wall), subcutaneously, or any other suitable location. The implanted power conversion device 1002 is configured to receive wireless energy E transmitted from an external power source 1004a housed in an external power transfer device 1004 located outside the patient's skin 1005 in the vicinity of the implanted power conversion device 1002.

It is well known in the art that wireless energy E can generally be transmitted by any suitable device for transdermal energy transfer, such as a device comprising a primary coil embodied in the external power source 1004a and a secondary coil located proximate thereto in the implanted device. 1002 for energy conversion. When electrical current is passed through the primary coil, energy in the form of voltage is induced in the secondary coil, which can be used to power implanted energy-consuming components of the installation, for example, after storing the incoming energy in an implanted energy source such as a battery or capacitor. However, the present invention is not generally limited to any particular energy transmission method, transdermal energy transmission devices, or energy sources, and any kind of wireless energy can be used.

[094] The amount of energy received by the implanted energy receiver can be compared to the energy used by the implanted components of the installation. The term "used energy" in this case also includes the energy stored in the implanted components of the installation. The control device includes an external control unit 1004b that controls the external power source 1004a based on a determined energy balance to regulate the amount of energy transmitted. To ensure the transfer of the proper amount of energy, the energy balance and the required amount of energy are determined by a determination device containing an implanted internal control unit 1015 connected between the switch 1026 and the installation 10. The internal control unit 1015 can thus be configured to obtain various measurements carried out by appropriate sensors and other similar devices (not shown), measuring certain characteristics of the installation 10, in some way reflecting the required amount of energy required for proper operation of the installation 10. In addition, also through suitable measuring devices or sensors, the current condition of the patient can be detected in order to provide parameters , reflecting the patient's condition. Therefore, such characteristics and/or parameters may be related to the current state of the unit 10, such as power consumption, operating mode and temperature, as well as the patient's condition, as indicated by parameters such as; body temperature, blood pressure, heart rate and breathing. Other types of patient physical parameters and device functional parameters are described elsewhere.

[095] In addition, an energy source in the form of a battery 1016 may optionally be coupled to the implanted energy conversion device 1002 via a control unit 1015 to store the resulting energy for later use by the unit 10. Additionally or alternatively, characteristics may also be measured of the specified battery, also reflecting the required amount of energy. The battery can be replaced by a rechargeable battery, and the measured characteristics can be related to the current state of the battery and any electrical parameter such as power consumption, voltage, temperature, etc. It must be understood that in order to provide sufficient voltage and current for the installation 10, as well as to avoid overheating, the battery must be optimally charged by receiving the appropriate amount of energy, i.e. not too much and not too little from the implanted energy conversion device 1002. The battery may also be a capacitor with appropriate characteristics.

For example, battery characteristics may be regularly measured to determine the current state of the battery, which information may then be stored as status information in appropriate storage means in the indoor control unit 1015. In this way, when new measurements are taken, the accumulated battery status information can be properly updated. In doing so, the battery's condition can be "calibrated" by transferring the proper amount of energy to keep the battery in optimal condition.

[096] Thus, the internal control unit 1015 of the determining device is configured to determine the energy balance and/or the current required amount of energy (energy per unit of time or accumulated energy) based on measurements made by the above sensors or measuring devices of the installation 10, or the patient , or an implanted energy source, if used, or any combination of the above. The internal control unit 1015 is also connected to an internal signal transmitter 1027 configured to transmit a control signal reflecting a certain required amount of energy to an external signal receiver 1004c coupled to the external control unit 1004b. Then, the amount of power transmitted from the external power source 1004a can be adjusted under the influence of the received control signal.

In another embodiment, the determination device may include an external control unit 1004b. In this embodiment, the sensor measurements can be transmitted directly to the external control unit 1004b, wherein the energy balance and/or the current required amount of energy can be determined by the external control unit 1004b, thereby embedding the above-described function of the internal control unit 1015 into the external control unit 1004b. In this case, the internal control unit 1015 can be omitted and the sensor measurements are provided directly to the internal signal transmitter 1027, which sends the measurements to the external signal receiver 1004c and the external control unit 1004b. Then, the energy balance and the current required amount of energy can be determined by the external control unit 1004b based on the specified sensor measurements.

[097] Thus, in the present solution according to the arrangement of FIG. 50 use feedback including data indicating energy required, which is a more efficient solution than previous solutions because it is based on actual energy use compared to energy received, for example regarding amount of energy, energy difference, or rate of energy production compared to the rate of energy use of the implanted energy-consuming components of the installation. The installation may use the received energy for consumption or for storing energy in an implanted energy source, etc. The various parameters described above are used as appropriate and necessary and then used as a tool to determine the actual energy balance. However, the specified parameters may also be necessary to perform any actions carried out in the patient's body to specifically control the operation of the installation.

The internal signal transmitter 1027 and the external signal receiver 1004c may be implemented as separate units using suitable signal transmission means such as radio signals, infrared or ultrasonic signals. In another embodiment, an internal signal transmitter 1027 and an external signal receiver 1004c may be built into the implanted power conversion device 1002 and the external power source 1004a, respectively, to transmit control signals in the reverse direction of the power transmission using a substantially identical transmission method. Control signals can be modulated in frequency, phase or amplitude.

[098] Thus, the feedback data may be transmitted through a separate communication system containing receivers and transmitters, or may be integrated into the power system. According to the present invention, such embedded feedback data and power system includes an implantable internal power receiver for receiving wireless power, wherein the power receiver has a first internal coil, a first electronic circuit coupled to the first coil, and an external power transmitter for transmitting wireless power, wherein the transmitter energy has a second external coil and a second electronic circuit connected to the second coil. The second outer power transmitter coil transmits wireless power received by the first power receiver coil. The system further includes a power switch for turning on and off the connection of the first internal coil and the first electronic circuit such that the external power transmitter receives feedback data related to the charging of the first coil in the form of a load resistance fluctuation of the second external coil when the power switch turns on or turns off the connection of the first internal coil and the first electronic circuit. When the above system is implemented in the arrangement of FIG. 50, the switch 1026 is separate from and controlled by the indoor control unit 1015 or integrated into the indoor control unit 1015. It should be understood that switch 1026 should be interpreted in its broadest sense. This means a transistor, microprocessor control unit, main control unit, application specific integrated circuit, field programmable gate array, digital to analog converter, or any other electronic component or circuit capable of turning power on and off.

[099] Finally, the power supply layout of FIG. 50 may operate essentially as follows. First, the energy balance is determined by the internal control unit 1015 of the determining device. A control signal reflecting the required amount of energy is also generated by the internal control unit 1015, and the control signal is transmitted from the internal signal transmitter 1027 to the external signal receiver 1004c. In another embodiment, the energy balance may be determined by the external control unit 1004b, depending on the execution method as described above. In this case, the control signal may contain measurement results from various sensors. The amount of power supplied from the external power source 1004a can then be adjusted by the external control unit 1004b based on a determined power balance, for example, under the influence of a received control signal. This process may be repeated periodically at regular intervals during the ongoing energy transfer, or may be carried out on a substantially continuous basis during the energy transfer.

The amount of energy transmitted can generally be adjusted by adjusting various transmission parameters in the internal energy source 1004a, such as voltage, current, amplitude, wave frequency, and pulse characteristics.

[100] This system can also be used to obtain information about coupling coefficients between coils in a transcutaneous power transfer system, even for the purpose of calibrating the system to determine the optimal location of the outer coil relative to the inner coil and to optimize power transfer. In this case, they simply compare the amount of energy transferred with the amount of energy received. For example, as the external coil moves, the coupling coefficient may change, and the accurately mapped movements can allow the optimal location of the external coil to be found for power transfer. Preferably, the external coil is configured to calibrate the amount of transmitted energy to obtain feedback data in the determination device until a maximum coupling coefficient is achieved.

The specified coupling coefficient data can also be used as feedback data for power transmission. In such a case, the power system according to the present invention includes an implantable internal power receiver for receiving wireless power having a first internal coil, a first electronic circuit coupled to the first coil, and an external power transmitter for transmitting wireless power having a second external coil and a second electronic circuit. , connected to the second coil. The second outer power transmitter coil transmits the wireless power received by the first power receiver coil. The system further comprises a feedback device for reporting the amount of energy received in the first coil as feedback data, wherein the second electronic circuit includes a determination device for receiving the feedback data and for comparing the amount of energy transmitted by the second coil with the feedback data relating to to the amount of energy received in the first coil in order to obtain the coupling coefficient between the first and second coils. The energy transmitter can adjust the transmitted energy under the influence of the resulting coupling coefficient.

[101] Referring to FIG. 51, although wireless power transmission for operation of the apparatus is disclosed in the above description for the purpose of providing non-invasive control, it should be understood that the apparatus may also be operated using wired power. A similar example is shown in FIG. 51, wherein an external switch 1026 is coupled between an external power source 1004a and an operating device such as an electric motor 1007 for operating the apparatus 10. The external control unit 1004b controls the operation of the external switch 1026 to effect proper operation of the apparatus 10.

In fig. 52 shows various options for implementing methods for supplying and using the received energy by installation 10. Similar to the example of claim 50, the internal power receiver 1002 receives wireless power E from the external power source 1004a controlled by the transmission control unit 1004b. The internal power receiver 1002 may include a constant voltage circuit, indicated as a dotted block "constant V" in the drawing, for supplying power to the installation 10 at a constant voltage. The internal power receiver 1002 may also include a constant current circuit, indicated as a dotted block "constant C" in the drawing, for supplying power to the installation 10 at a constant current.

[102] The apparatus 10 includes a power consuming portion 10a, which may be a motor, a pump, a limiting device, or any other medical device that requires energy to operate electrically. The installation 10 may also include a power storage device 10b for storing power supplied from the internal power receiver 1002. Thus, the supplied power may be directly consumed by the power consuming portion 10a, or may be stored in the power storage device 10b, or may be partially consumed and partially stored. The installation 10 may also include a power stabilizing unit 10c for stabilizing the power supplied from the internal power receiver 1002. Thus, energy may be supplied in an irregular manner such that it may be necessary to stabilize the energy before consumption or storage. The energy supplied from the internal energy receiver 1002 may also be stored and/or stabilized by a separate energy stabilization unit 1028 located outside the unit 10 before being consumed and/or stored by the unit 10. In another embodiment, the energy stabilization unit 1028 may be built into internal energy receiver 1002. In any case, power conditioning unit 1028 may include a constant voltage circuit and/or a constant current circuit.

[103] It should be noted that in FIG. 50 and fig. 52 shows some possible but non-limiting embodiments with respect to the arrangement and interconnection of the various functional components and elements shown. However, it will be apparent to one skilled in the art that many variations and modifications can be made within the scope of the present invention.

In fig. 53 is a schematic diagram of an energy balance measurement circuit for one of the proposed configurations of a wireless power transmission control system, or energy balance management system. The system has an output signal centered at 2.5 V, directly proportional to the energy imbalance. The derivative of a given signal shows whether the value is increasing or decreasing, and how quickly the specified change occurs. If the amount of energy received is lower than the amount of energy used by the implanted components of the installation, more energy is transferred, thereby charging into the energy source. The output signal from the circuit is usually sent to an analog-to-digital converter and converted into a digital format. The digital data can then be sent to an external energy transfer device, allowing the device to adjust the level of energy transferred. Another option could be an all-analog system that uses comparators that compare the energy balance level to certain maximum and minimum thresholds and send data to an external device to transfer energy if the balance falls outside the minimum/maximum window.

[104] The circuit shown schematically in FIG. 53 depicts a circuit implementation for a system that transfers energy to the implanted energy components of the apparatus of the present invention from outside the patient's body through inductive energy transfer. An inductive power transfer system typically uses an external transmitting coil and an internal receiving coil. The receiving coil L1 is shown in the diagram in Fig. 36; The transmitting parts of the system are not shown.

The implementation of the general concept of energy balance and the method of transmitting information to an external energy transmitter can be accomplished in many different ways. Scheme according to Fig. 53 and the above-described method of evaluating and transmitting data should be considered only as examples of the implementation of the control system.

DETAILED DESCRIPTION OF THE SCHEME

[105] In FIG. 53 characters Y1, Y2, Y3, etc. control points are indicated on the diagram. The components in the diagram and their corresponding values represent values suitable for this particular embodiment, which is only one of an infinite number of possible configurations.

The energy receiving coil L1 receives energy to power the circuit. In this particular case, energy is transmitted to the implanted components at a frequency of 25 kHz. The energy balance output signal is at control point Y1.

It will be apparent to one skilled in the art that the above system implementations can be combined in a variety of different ways. For example, electrical switch 1006 of FIG. 36 may be used in any of the embodiments of FIG. 39-45, the hydraulic valve shifter 1014 of FIG. 39 may be used in the embodiment of FIG. 38, and the gearbox 1024 may be used in the embodiment of FIG. 37. It should be noted that a switch can be literally any electronic circuit or component.

In the embodiments described in FIGS. 50, 52 and 53 disclose a method and system for controlling the transmission of wireless energy to implantable energy-consuming components of an electrical installation. The method and system are defined below in general terms.

[106] Thus, a method is provided for controlling the transmission of wireless power supplied to implantable power consuming components of the above-described installation. Wireless energy E is transmitted from an external energy source located outside the patient and received through an internal energy receiver located inside the patient and connected to the implanted energy consuming components of the installation to directly or indirectly supply the received energy to them. Determine the energy balance between the energy received by the internal energy receiver and the energy used for the installation. The transmission of wireless energy E from an external energy source is then controlled based on a determined energy balance.

Wireless energy can be transferred inductively from a primary coil in an external power source to a second coil in an internal power receiver. A change in energy balance may be detected for the purpose of controlling wireless power transmission based on the detected change in energy balance. A difference between the energy received by the internal power receiver and the energy used for the medical device may also be detected to control wireless power transmission based on the detected energy difference.

[107] When controlling power transmission, the amount of transmitted wireless power may be reduced if a detected change in the energy balance indicates an increase, or vice versa. The decrease/increase in energy transfer may also correspond to the detected rate of change.

The amount of wireless energy transmitted may also be reduced if the detected energy difference indicates that the energy received is greater than the energy used, or vice versa. The decrease/increase in energy transfer in such a case may correspond to the magnitude of the detected energy difference.

As described above, the energy used for the medical device may be consumed to operate the medical device and/or stored in at least one energy storage device of the medical device.

Once the electrical and/or physical parameters of the medical device and/or the physical parameters of the patient are determined, energy can be transferred for consumption and storage in accordance with the transmission rate per unit of time determined based on the specified parameters. The total amount of energy transferred can also be determined based on the specified parameters.

[108] If a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is related to the time integral of at least one measured electrical parameter associated with said energy balance, there may be an integral is defined for the monitored voltage and/or current associated with the energy balance.

If the time derivative of a measured electrical parameter associated with the amount of energy consumed and/or stored is determined, a derivative of the monitored voltage and/or current associated with the energy balance can be determined.

Transmission of wireless power from an external power source may be controlled by applying to the external power source electrical pulses from a first electrical circuit for transmitting wireless power, wherein the electrical pulses have rising and falling edges with varying the duration of the first time periods between successive rising and falling edges of the electrical pulses and/or durations of second time periods between successive falling and rising edges of the electrical pulses and wireless energy transmission, wherein the transmitted wireless energy generated from the electrical pulses has varying power depending on the duration of the first and/or second time periods.

[109] In this case, the frequency of the electrical pulses may be substantially constant while varying the first and/or second time periods. When electrical pulses are applied, they may remain unchanged except for varying first and/or second time intervals. The amplitude of the electrical pulses may be substantially constant while varying the first and/or second time periods. In addition, the electrical pulses can be varied by varying only the duration of the first time intervals between successive rising and falling edges of the electrical pulses.

A train of at least two electrical pulses may be applied in succession, and when a pulse train is applied, a pulse train having a first electrical pulse at the beginning of the pulse train and having a second electrical pulse at the end of the pulse train, at least two pulse trains may be applied in succession , and the duration of the second time intervals between successive falling edges of the second electrical pulse in the first pulse train and the leading edge of the first electrical pulse of the second pulse train varies.

[110] When electrical pulses are applied, they may have a substantially constant current and a substantially constant voltage. The electrical pulses may also have a substantially constant current and a substantially constant voltage. In addition, the electrical pulses may also have a substantially constant frequency. The electrical pulses in the pulse train may also have a substantially constant frequency.

The circuit formed by the first electrical circuit and the external power source may have a first characteristic time period or first time constant, and by effectively varying the transferred energy, said frequency time period may be within the first characteristic time period or time constant, or may be shorter.

Also proposed is a system comprising the above-described apparatus for controlling the transmission of wireless energy supplied to the implantable power consuming components of the apparatus. In the broadest sense, the system includes a control device for controlling the transmission of wireless energy from the energy transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, coupled to the implantable energy consuming components of the installation for directly or indirectly supplying the received energy thereto.

[111] The system also includes a determination device configured to determine the energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the installation, wherein the control device controls the transmission of wireless energy from the external energy transmission device based on the energy balance , determined by the determining device.

In one embodiment, the at least one battery may be configured as part of or replaces the power conversion device 1002 to supply power to the power line installation 10. In one embodiment, the battery is not rechargeable. In another embodiment, the battery is rechargeable.

Naturally, the battery power may be located remotely or may be built into the device.

[112] In addition, the system may contain any of the following elements:

- A primary coil in an external power source configured to inductively transfer energy to a second coil in an internal power receiver.

- The detecting device is configured to detect changes in the energy balance, and the control device controls the transmission of wireless energy based on the detected changes in the energy balance.

- The detecting device is configured to detect the difference between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the installation, and the control device controls the transmission of wireless energy based on the detected energy difference.

- The control device controls the external device for transmitting energy to reduce the amount of transmitted wireless energy if the detected change in the energy balance indicates an increase in the energy balance, or vice versa, and the decrease/increase in the transmitted energy corresponds to the detected rate of change.

- The control device controls the external power transmission device to reduce the amount of transmitted wireless energy if the detected energy difference indicates that the received energy is greater than the used energy, or vice versa, with the decrease/increase in energy transmission corresponding to the amount of the detected energy difference.

- The energy used for the installation is consumed to ensure the operation of the installation and/or is stored in at least one energy storage device of the installation.

- Once the electrical and/or physical parameters of the installation and/or the physical parameters of the patient are determined, the energy transfer device transmits energy for consumption and storage in accordance with the transmission rate per unit of time determined by the determination device based on the specified parameters.

[113] The determination device also determines the total amount of transmitted energy based on the specified parameters.

- If a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is associated with the time integral of at least one measured electrical parameter associated with the specified energy balance, the determining device determines the integral for monitored voltage and/or current associated with energy balance.

- If the time derivative of a measured electrical parameter associated with the amount of energy consumed and/or stored is determined, the determination device determines the derivative for the monitored voltage and/or current associated with the energy balance.

- The power transmission device includes a coil located outside the human body, and an electrical circuit is provided to power the external coil with electrical pulses to transmit wireless power. The electrical pulses have rising and falling edges, and the electrical circuitry is configured to vary the first time intervals between successive rising and falling edges and/or the second time intervals between successive falling and rising edges of the electrical pulses to vary the power of transmitted wireless energy.

[114] As a result, the power receiver receiving the transmitted wireless power has varying power.

- The electrical circuit is configured to deliver electrical pulses that remain unchanged except for varying first and/or second time intervals.

- The electrical circuit has a time constant and is designed to vary the first and second time periods only within the first time constant, as a result of which, when the duration of the first and/or second time periods is varied, the power transmitted through the coil varies.

- The electrical circuit is configured to deliver electrical pulses that vary only by varying the duration of the first time intervals between successive rising and falling edges of the electrical pulses.

- The electrical circuit is configured to supply a chain of at least two electrical pulses in a row, said chain having a first electrical pulse at the beginning of the pulse train and a second electrical pulse at the end of the pulse train, and - the duration of the second time intervals between successive falling edges of the second electrical pulse in the first pulse train and the leading edge of the first electrical pulse of the second pulse train is varied by the first electrical circuit.

- The electrical circuit is configured to provide electrical pulses in the form of pulses having a substantially constant height and/or amplitude and/or intensity and/or voltage and/or current and/or frequency.

- The electrical circuit has a time constant and is configured to vary the first and second time periods only within the first time constant, as a result of which, when the duration of the first and/or second time periods is varied, the power transmitted through the first coil varies.

- The electrical circuit is configured to provide electrical pulses with varying durations of the first and/or second time periods only within limits including the first time constant, or having values relatively close to the first time constant, compared to the value of the first time constant.

[115] In FIG. 54-57 show in more detail block diagrams of four different methods for hydraulically or pneumatically powering an implanted device in accordance with the present invention.

In fig. 54 shows the above described system. The system includes an implanted unit 10 and also a separate control reservoir 1013, a one-way pump 1009 and a variable valve 1014.

In fig. 55 shows installation 10 and fluid reservoir 1013. By moving the wall of the control reservoir or otherwise changing its dimensions, adjustment of the installation can be made without the use of any valve, allowing free passage of fluid at any time by moving the wall of the reservoir.

In fig. 56 shows installation 10, two-way pump 1009, and control reservoir 1013.

[116] In FIG. 57 is a block diagram of a reversible servomotor system with a first closed system controlling a second closed system. The servomotor system includes a control reservoir 1013 and a servomotor reservoir 1050. The servomotor reservoir 1050 mechanically controls the implanted unit 10 through a mechanical connection 1054. The apparatus has an expandable/contractable cavity.

The cavity preferably expands or contracts due to the supply of hydraulic fluid from a larger adjustable reservoir 1052 in fluid connection with the installation 10. In another embodiment, the cavity contains a compressible gas that can be compressed or expanded under the control of the servo-motor reservoir 1050.

The servo motor reservoir 1050 may also be formed as part of the installation itself.

[117] In one embodiment, the control reservoir is placed under the patient's skin and is operated by pressing the outer surface of the reservoir with a finger. This system is shown in Fig. 58a-c. In fig. 58a, the flexible subcutaneous control reservoir 1013 is shown connected to the convex servo reservoir 1050 via a channel 1011. The corrugated servo reservoir 1050 is housed in the flexible assembly 10. In the position of FIG. 58a, the servo reservoir 1050 contains a minimal amount of fluid, and most of the fluid is housed in the control reservoir 1013. Due to the mechanical connection between the servo reservoir 1050 and the installation 10, the outer shape of the installation 10 is compressed, i.e. it occupies a volume less than its maximum volume. The specified maximum volume is shown in the drawing with a dotted line.

In fig. 58b shows a position in which a user, such as an implant patient, presses on the control reservoir 1013 such that the fluid contained therein is forced to flow through the channel 1011 into the servo-motor reservoir 1050, which expands in the longitudinal direction due to its corrugated shape . This expansion in turn causes the installation 10 to expand so that it occupies its maximum volume, thereby stretching the wall of the stomach (not shown) with which it is in contact.

[118] The control reservoir 1013 is preferably provided with means 1013a for maintaining its shape after compression. Said means, as schematically shown in the drawing, thus hold the installation 10 in an extended state when the user releases the control reservoir. Thus, the control reservoir essentially acts as a switch that turns the system on and off.

An alternative embodiment of hydraulic or pneumatic operation is described below with reference to FIG. 59 and 60a-c. Block diagram of Fig. 59 includes a first closed system that controls a second closed system. The first system includes a control reservoir 1013 and a servo motor reservoir 1050. The servo motor reservoir 1050 mechanically controls the larger adjustable reservoir 1052 through a mechanical connection 1054. The implanted unit 10 having an expandable/contractible cavity is in turn controlled by the larger adjustable reservoir 1052 through the supply of hydraulic fluid. from a larger adjustable reservoir 1052 in fluid communication with unit 10.

[119] An example of this embodiment is described below with reference to FIG. 60a-c. As in the previous embodiment, the regulatory reservoir is placed under the patient's skin, and its operation is carried out by pressing the outer surface of the reservoir with a finger. The control reservoir 1013 is in fluid communication with the corrugated servo reservoir 1050 via a channel 1011. In the first closed system 1013, 1011, 1050 of FIG. 60a, the servo reservoir 1050 contains a minimal amount of fluid, and the majority of the fluid is located in the control reservoir 1013.

Servo reservoir 1050 is mechanically coupled to a larger adjustable reservoir 1052, in this example also corrugated but having a larger diameter than servo reservoir 1050. The larger adjustable reservoir 1052 is in fluid connection with assembly 10. This means that when the user presses the control reservoir 1013, thereby pushing fluid from the control reservoir 1013 into the servo reservoir 1050, the expansion of the servo reservoir 1050 allows a larger volume of fluid to be pushed from the larger adjustable reservoir 1052 into the installation 10. In other words, in this reversing servo mechanism, a small the volume in the control reservoir is compressed with greater force, resulting in a larger total area moving with less force per unit area.

[120] As in the previous embodiment described above with reference to FIG. 58a-c, the control reservoir 1013 is preferably provided with means 1013a for maintaining its shape after compression. Said means, as schematically shown in the drawing, thus hold the installation 10 in an extended state when the user releases the control reservoir. Thus, the control reservoir essentially acts as a switch that turns the system on and off.

Although the various parts described above are located in specific locations in the drawings, it should be understood that said locations may vary depending on the application.

The lubricating fluid used in any of the embodiments disclosed herein is preferably a biocompatible lubricating fluid that mimics the synovial fluid of the natural hip joint. In one embodiment, the lubricating fluid is hyaluronic acid.

[121] In all of the above-described embodiments, it is assumed that the implementation of the channel is eliminated, and the channel or channels are in direct connection with the reservoir or inlet channel. It should be noted that any embodiment or part of an implementation, as well as any method or part of a method, can be combined in any way. All the examples given must be considered as part of a general description, as a result of which they can generally be combined in any way. It should be noted that the description as a whole should be considered as a description of the installation and method.

The various features of the invention described above can be combined in any way as long as the combination is not obviously inconsistent. The present invention will be described in detail below with respect to preferred embodiments and with reference to the accompanying drawings. Likewise, individual features of different embodiments may be combined or interchanged as long as the combination or substitution does not conflict with the overall function of the device.

1. An implantable lubricating device according to claim 10, wherein said reservoir is configured to change its volume to establish a flow of lubricating fluid into the joint.

2. The implantable lubrication device of claim 11, wherein the reservoir includes a flexible outer wall for varying the volume of the reservoir to establish a flow of lubricating fluid into the joint.

3. Implantable lubricating device according to any one of paragraphs. 11-12, wherein the reservoir includes a gas chamber configured to function as a spring to change the volume of the reservoir to establish a flow of lubricating fluid into the joint.

4. Implantable lubricating device according to any one of paragraphs. 3-13, wherein said replenishment inlet comprises a self-sealing permeable membrane.

5. Implantable lubricating device according to any one of paragraphs. 3-14, wherein the fluid connection device is configured to establish a circulatory current of lubricating fluid within the lubricating device through the joint.

6. The implantable lubricating device of claim 15, wherein the fluid connection device is configured to establish a continuous or intermittent circulatory current of lubricating fluid within the lubricating device.

17. Implantable lubricating device according to any one of paragraphs. 15 and 16, wherein the fluid connection device comprises a filter device comprising a filter configured to remove impurities from a circulating current of the lubricating fluid.

18. The implantable lubricating device of claim 17, wherein the filter device comprises a cleaning device configured to clean said filter.

19. Implantable lubricating device according to any one of paragraphs. 17 and 18, wherein the filter device includes a sealed deposit space, the filter device being configured to accommodate removed contaminants within said sealed deposit space.

20. Implantable lubricating device according to any one of paragraphs. 17 and 18, wherein the filter device is configured to return said removed impurities back into the patient's body.

21. An implantable lubrication system comprising an implantable lubrication device according to any one of claims. 1-20 and a lubricating fluid, wherein said lubricating fluid is capable of being stored in a reservoir and introduced into the joint via a fluid connection.

22. The lubrication system of claim 21, wherein said lubricating fluid is resorbable.

23. Lubrication system according to any one of paragraphs. 21 and 22, in which the lubricating fluid is hyaluronic acid.

24. The implantable medical device of claim 14, wherein the reservoir is configured to be pre-filled with a pressurized lubricating fluid by injection into said inlet port.

25. The implantable medical device of claim 24, wherein the implantable inlet port is configured to preload the reservoir with pressurized lubricating fluid by introducing the fluid into the inlet port.

26. The implantable medical device of claim 25, further comprising a valve configured to close the connection between the reservoir and the joint.

27. The implantable medical device of claim 1, configured to lubricate at least one artificial contact surface implanted into a joint of a human or mammalian body to replace at least the surface of at least one of the at least two natural contact surfaces of the mammalian joint, and bearing the load in the joint, containing:

a. at least one outlet configured to receive lubricating fluid from said reservoir, and wherein

b. said medical device is configured to operate, controlled by an artificial operating device, to distribute a lubricating fluid from a reservoir to said outlet for lubricating the at least one artificial contact surface.

28. Implantable medical device according to any one of paragraphs. 1 and 27, wherein said reservoir and the joint are spaced apart in a space containing a fluid connection path between the reservoir and the joint.

29. Implantable medical device according to any one of paragraphs. 1 and 27, which includes at least one channel configured to distribute a lubricating fluid over the surface of the artificial contact surface on at least two parts of the artificial contact surface to lubricate it.

30. Implantable medical device according to any one of paragraphs. 1 and 27, further comprising an operating device configured to transfer a lubricating fluid from a reservoir to an artificial contact surface to lubricate it.

31. The implantable medical device of claim 30, wherein the operating device may be a powered operating device.

32. Implantable medical device according to any one of paragraphs. 1 and 27, which is configured to lubricate the patient's hip joint.

33. Implantable medical device according to any one of paragraphs. 1 and 27, which is configured to lubricate the patient's knee joint.

34. Implantable medical device according to any one of paragraphs. 1 and 27, comprising a channel configured to pass through the bone of the patient's body to long-term maintain an open path through said bone, allowing the lubricating fluid to reach the artificial contact surface.

35. Implantable medical device according to any one of paragraphs. 1 and 27, comprising a channel configured to pass through the joint capsule of the patient's body to long-term maintain an open path through said joint capsule, allowing the lubricating fluid to reach the artificial contact surface.

36. Implantable medical device according to any one of paragraphs. 1 and 27, which is configured to supply lubricant to the hip joint through an opening in the pelvic bone on the ventral side of the pelvic bone.

37. Implantable medical device according to any one of paragraphs. 1 and 27, wherein the reservoir is configured to be at least partially located within the patient's bone.

38. The implantable medical device of claim 37, wherein the reservoir is configured to be at least partially located within the patient's femur.

39. The implantable medical device of claim 37, wherein the reservoir is configured to be at least partially located within the patient's pelvic bone.

40. The implantable medical device of claim 37, wherein the reservoir is configured to be at least partially located within the patient's femoral neck.

41. Implantable medical device according to any one of paragraphs. 1 and 27, wherein the reservoir is configured to be placed subcutaneously or placed in a cavity in the body.

i. 42. Implantable medical device according to any one of paragraphs. 1 and 27, wherein the reservoir is configured to be placed subcutaneously or in a body cavity in an area of the patient selected from the group of areas consisting of:

ii. abdominal region,

iii. groin area,

iv. pelvic area and

v. thigh area.

43. The implantable medical device according to claim 42, in which the reservoir is configured to be placed in the abdominal cavity.

44. The implantable medical device according to claim 14, wherein the replenishing inlet channel is configured to be implanted subcutaneously.

45. The implantable medical device of claim 14, wherein the replenishment inlet channel is configured to be implanted in connection with bone.

46. The implantable medical device of claim 27, which is configured to lubricate one artificial contact surface and an opposing contact surface of the hip joint of a human or mammalian patient.

47. The implantable medical device of claim 27, which is configured to lubricate the at least one artificial contact surface and the at least one opposing contact surface of a knee joint of a human or mammalian patient.

48. The implantable medical device of claim 27, wherein the knee joint has two medial and two lateral contact bearing surfaces, wherein said implantable medical device is configured to lubricate at least one artificial contact surface on the medial side of the knee joint of a human patient or mammals.

49. The implantable medical device of claim 27, wherein the knee joint has two medial and two lateral contact bearing surfaces, wherein said implantable medical device is configured to lubricate at least one artificial contact surface on the lateral side of the knee joint of a human patient or mammals.

50. A method of treating a human or mammalian patient with an implantable lubricating device according to any one of claims. 1-20 and 22-49, including the following steps:

- opening by dissection a suitable area for the lubricating device in the patient's body, including the joint area;

- placing the lubricating device at a specified suitable location in the patient's body such that a fluid connection is formed for introducing the lubricating fluid into the joint in the area of the joint;

- covering the patient's body after placing the lubricating device so that the lubricating device is completely implanted in the patient's body; And

- post-operative introduction of a lubricating fluid into the reservoir of the lubricating device to ensure sufficient lubrication of the joint.

51. A method of treating a human or mammalian patient using an implantable lubricating device according to any one of claims. 1-20 and 22-49, including the following steps:

- opening by dissection a suitable area for the lubricating device in the patient's body;

- expansion of the cavity located in the immediate vicinity of the joint by introducing gas through a needle-shaped or tubular instrument inserted into the patient’s body;

- placement in said cavity of at least two laparoscopic trocars and insertion of a camera, as well as insertion into the cavity by means of laparoscopic trocars of at least one dissecting instrument;

- opening by dissection of the joint area by means of the specified inserted dissecting instrument;

- placing a lubricating device at said suitable location such that a fluid connection is formed through said laparoscopic trocars for introducing the lubricating fluid into the joint in the region of the joint;

- covering the patient's body after placing the lubricating device so that the lubricating device is completely implanted in the patient's body; And

- post-operative introduction of a lubricating fluid into the reservoir of the lubricating device to ensure sufficient lubrication of the joint.

52. The method according to any one of claims 50 and 51, wherein the fluid connection infusion member comprises a tube and the step of placing a lubricating device at said suitable area includes the following steps:

- placement of the lubricating device reservoir in a suitable area;

- making a hole in the articular capsule in the joint area; And

- inserting said tube into said opening such that the open end of the tube is in continuous communication with the joint and the lubricating fluid stored in the reservoir is continuously introduced into the joint.

53. The method according to any one of claims 51 and 52, wherein the infusion element of the fluid connection includes an infusion needle, and the step of placing the lubricant device at a suitable site includes the following steps:

- placement of the lubricating device reservoir in a suitable area; And

- placing the infusion needle in close proximity to the joint area such that the drive mechanism of the infusion needle periodically inserts it into the joint so that the lubricating fluid stored in the reservoir is periodically introduced into the joint.

54. Method according to any one of paragraphs. 50-53, wherein the flow of lubricating fluid into the joint is established within the implanted fluid lubricating device by means of a pump or motor connected to the fluid connecting device, or by changing the volume of a reservoir located in the reservoir, by means of a flexible outer wall or gas chamber reservoir.

55. Method according to any one of paragraphs. 50-54, wherein the lubricating device is positioned at a suitable location such that a continuous or intermittent circulatory flow of lubricating fluid is established within the lubricating device through the joint.

56. The method of claim 55, wherein the filter device of the fluid coupling device removes impurities from a circulating current of the lubricating fluid.

57. Method according to any one of paragraphs. 50-56, in which the lubricating fluid is introduced into the reservoir after the operation through the replenishing inlet of the reservoir.

58. Method according to any one of paragraphs. 50-57, wherein the lubricating device is positioned at a suitable location such that the infusion element is positioned in communication with the hip or knee joint capsule.

59. A system containing an implantable medical device according to any one of paragraphs. 1-49.

60. The system of claim 59, further comprising at least one switch implantable in the patient to manually and non-invasively control the implantable medical device.

61. The system of claim 59, further comprising a hydraulic device having an implantable hydraulic reservoir hydraulically coupled to the implantable medical device, wherein the implantable medical device is non-invasively adjustable by manually pressing the hydraulic reservoir.

62. The system of claim 59, further comprising a wireless remote control device for non-invasively controlling the implantable medical device.

63. The system of claim 62, wherein the wireless remote control device comprises at least one external signal transmitter and/or signal receiver, and also comprises an internal signal receiver and/or signal transmitter implanted in the patient to receive signals transmitted by the external transmitter signal or transmitting signals to an external signal receiver.

64. The system of claim 62, wherein the wireless remote control device transmits at least one wireless control signal to control the implantable medical device.

65. The system of claim 64, wherein the wireless control signal comprises a signal modulated in frequency, amplitude, phase, or a combination thereof.

66. The system of claim 64, wherein the wireless remote control device transmits an electromagnetic carrier wave signal to carry the control signal.

67. The system of claim 59, further comprising a wireless power transmission device for non-invasively providing wireless power to the implantable energy consuming components of the implantable medical device.

68. The system of claim 67, wherein the wireless energy comprises a wave signal selected from the following group: an audio wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal signal, microwave signal, RF signal, X-ray signal and gamma ray signal.

69. The system of claim 67, wherein the wireless energy comprises one of an electric field, a magnetic field, or a combined electric and magnetic field.

70. The system of claim 64, wherein the control signal comprises one of an electric field, a magnetic field, or a combined electric and magnetic field.

71. The system according to any one of paragraphs. 64 and 68, wherein the signal comprises an analog signal, a digital signal, or a combination of an analog and digital signal.

72. The system of claim 59, further comprising an implantable internal power source for powering implantable energy-consuming components of the implantable medical device.

73. The system of claim 72, further comprising an external power source for transmitting energy wirelessly, wherein the internal power source is configured to be charged by energy transmitted wirelessly.

74. The system of claim 73, further comprising a sensor or measuring device that detects or measures a functional parameter associated with energy transfer to charge the internal energy source, and a feedback device for sending feedback data from inside the patient's body to the outside, wherein the feedback data is coupled with a functional parameter determined by a sensor or measured by a measuring device.

75. The system of claim 59, further comprising a feedback device for sending feedback data from inside the patient's body to the outside, wherein the feedback data is associated with at least one of a physical parameter of the patient and a functional parameter related to the implantable medical device.

76. The system of claim 59, further comprising a sensor and/or measuring device and an implantable internal control unit for controlling the implantable medical device under the influence of data associated with at least one of a physical parameter of the patient determined by the sensor or measured measuring device, and a functional a parameter related to an implantable medical device and determined by a sensor or measured by a measuring device.

77. The system of claim 76, wherein the physical parameter is pressure or motor activity.

78. The system of claim 59, further comprising an external data transmitter and an implantable internal data transmitter coupled to the external data transmitter, wherein the internal transmitter supplies data related to the implantable medical device or patient to the external data transmitter, and/or the external data transmitter supplies data to the internal data transmitter.

79. The system of claim 59, further comprising a motor or pump for operating the implantable medical device.

80. The system of claim 59, further comprising a hydraulic operating device for operating the implantable medical device.

81. The system of claim 59, further comprising an operating device for providing operation of the implantable medical device, wherein the operating device comprises a servo drive configured to reduce the force required by the operating device to ensure operation of the implantable medical device instead of prolonged operation of the operating device, increasing the specified time actions.

82. The system of claim 67, further comprising an operating device for operating the implantable medical device, wherein the wireless energy in the wireless state is used to directly provide energy to the operating device to generate kinetic energy for operating the implantable medical device when the wireless energy is transmitted by the energy transfer device.

83. The system of claim 67, further comprising a power conversion device for converting wireless power transmitted by the power transfer device from a first energy form to a second energy form.

84. The system of claim 83, wherein the energy conversion device directly supplies implantable energy consuming components of the implantable medical device with a second form of energy due to the conversion of the first form of energy transmitted by the energy transfer device into a second form of energy by the energy conversion device.

85. The system of claim 83, wherein the second form of energy comprises at least one of direct current, pulsating direct current, and alternating current.

86. The system of claim 83, further comprising an implantable battery, wherein the second form of energy is used to at least partially charge the battery.

87. The system of claim 83, wherein the first or second form of energy comprises at least one of magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy, thermal energy, non-magnetic energy , non-kinetic energy, non-chemical energy, non-sonic energy, non-nuclear energy and non-thermal energy.

88. The system of claim 59, further comprising implantable electrical components comprising at least one voltage level protective device and/or at least one DC protective device.

89. The system of claim 67, further comprising a control device for controlling the transmission of wireless energy from the energy transmission device and an implantable internal energy receiver for receiving the transmitted wireless energy, wherein the internal energy receiver is connected to implantable energy consuming components of the implantable medical device for direct or indirect delivery the energy received on them; the system further comprises a determination device configured to determine an energy balance between energy received by the internal energy receiver and energy used for implantable energy consuming components of the implantable medical device, wherein the control device controls wireless energy transmission from the external energy transmission device based on the energy balance, determined by the identifying device.

90. The system of claim 89, wherein the detecting device is configured to detect a change in the energy balance, and the control device controls the transmission of wireless power based on the detected change in the energy balance.

91. The system of claim 89, wherein the sensing device is configured to detect a difference between energy received by the internal power receiver and energy used for implantable power consuming components of the implantable medical device, and the control device controls wireless power transmission based on the detected energy difference.

92. The system of claim 67, wherein the energy transmitting device comprises a coil located outside the human body and further comprising an implantable energy receiver located inside the human body, and electrical circuitry coupled to the external coil to power it through electrical pulses for wireless transmission. energy, wherein the electrical pulses have leading and falling edges, and the electrical circuit is configured to vary the first time intervals between successive rising and falling edges and/or the second time intervals between successive falling and rising edges of the electrical pulses to vary the power of the transmitted wireless energy, wherein the receiver energy receives transmitted wireless energy having varying power.

93. The system of claim 92, wherein the electrical circuitry is configured to deliver electrical pulses that remain constant except for varying first and/or second time intervals.

94. The system according to claim 92, in which the electrical circuit has a time constant and is configured to vary the first and second time periods only within the first time constant in such a way that when the duration of the first and/or second time periods is varied, the power transmitted through the coil varies .

95. The system of claim 75, further comprising an implantable internal power receiver for receiving wireless power, having a first internal coil, first electronic circuitry coupled to the first coil, and an external power transmitter for transmitting wireless power, wherein the power transmitter has a second external coil and a second electronic circuit coupled to the second coil, wherein the second outer power transmitter coil transmits wireless power received by the first power receiver coil, and the system further includes a power switch for turning on and off the connection of the first inner coil and the first electronic circuit such that the outer power transmitter receives feedback data related to the charging of the first coil in the form of a load resistance fluctuation of the second outer coil when the power switch turns on or off the connection of the first inner coil and the first electronic circuit.

96. The system of claim 75, further comprising an implantable internal power receiver for receiving wireless energy having a first internal coil, a first electronic circuit coupled to the first coil, and an external power transmitter for transmitting wireless energy having a second external coil and a second electronic circuit. coupled to a second coil, wherein the second outer power transmitter coil transmits wireless power received by the first power receiver coil, and the system further comprises a feedback device for reporting the amount of power received in the first coil as feedback data, wherein the second electronic the circuit includes a detector for receiving feedback data and for comparing the amount of energy transmitted by the second coil with feedback data relating to the amount of energy received in the first coil to obtain coupling coefficients between the first and second coils.

97. The system of claim 96, wherein the energy transmitter adjusts the transmitted energy under the influence of the obtained coupling coefficient.

98. The system of claim 96, wherein the second outer coil is movable relative to the first inner coil to establish an optimal placement of the second coil that maximizes coupling ratio.

99. The system of claim 98, wherein the second external coil is configured to calibrate the amount of transmitted energy to obtain feedback data in the determination device until a maximum coupling factor is achieved.

Claims (47)

1. An implantable lubricating medical device for implantation into a joint of a mammal, comprising: an artificial contact surface configured to replace at least one joint contact surface and to be lubricated after implantation into said joint; a tank containing a movable wall part forming a volume of the tank; at least one inlet port configured to receive lubricating fluid from the reservoir; at least one channel at least partially embedded in said artificial contact surface, the channel being fluidly coupled to said at least one inlet for distributing said lubricating fluid over a surface of said artificial contact surface; an operating device configured to non-invasively transfer said lubricating fluid from said reservoir to said artificial contact surface; And an implantable inlet port for refilling said reservoir, wherein the movable wall portion is movable when the reservoir is refilled to increase the volume of the reservoir. 2. The implantable lubricating medical device according to claim 1, wherein the artificial contact surface is an artificial tibia contact surface configured to replace at least one of a medial portion and a lateral portion of the tibia contact surface of the knee joint. 3. The implantable lubricating medical device according to claim 1, wherein the artificial contact surface is an artificial femoral contact surface configured to replace at least one of a medial portion and a lateral portion of the femoral contact surface of the knee joint. 4. The implantable lubricating medical device according to claim 1, wherein the artificial contact surface is one of an artificial femoral head or an artificial acetabulum configured to replace the anatomical contact surface of the femoral head or the anatomical contact surface of the acetabulum, respectively. 5. An implantable lubricating medical device according to any one of the preceding claims, wherein the reservoir is configured to be pre-filled with a lubricating fluid under pressure. 6. An implantable lubricating medical device according to any of the preceding claims, wherein said operating device is at least one of the group consisting of: a. working device under electrical voltage; b. mechanized working device; c. a pump configured to pump a lubricating fluid from a reservoir to an artificial contact surface to lubricate it. 7. The implantable lubricating medical device of any one of the preceding claims, further comprising a valve configured to close the connection between the reservoir and the artificial contact surface. 8. The implantable lubricating medical device according to any one of the preceding claims, wherein the reservoir is housed in a block separate from the artificial contact surface and is configured to be connected to the artificial contact surface via a channel. 9. An implantable lubricating medical device according to any of the previous paragraphs, in which the movable part of the wall is mechanized and is configured to move and change the volume of the reservoir. 10. An implantable lubricating medical device according to any one of the preceding claims, further comprising at least one outlet and at least one additional channel at least partially embedded in the artificial contact surface, wherein the medical device is configured to circulate a lubricating fluid from artificial contact surface through the outlet hole and to the artificial contact surface through the inlet hole. 11. The implantable lubricating medical device according to claim 10, also containing at least one of the group consisting of: a. a working device configured to circulate a lubricating fluid; b. a reservoir configured to add fluid to the circulating lubricating fluid; And c. a filter configured to purify the circulating lubricating fluid. 12. The implantable lubricating medical device according to any one of the preceding claims, wherein the reservoir is configured to apply pressure to the lubricating fluid. 13. The implantable lubricating medical device according to claim 12, wherein the reservoir has at least one of the following properties: a. is spring-loaded; b. contains a chamber configured to hold compressed gas; c. contains an elastic wall configured to create pressure; And d. contains a silicone elastic wall coated with parylene. 14. An implantable lubricating medical device according to any one of the preceding claims, comprising a system for manually and non-invasively controlling the implantable medical device, comprising at least one of the group consisting of: a switch implanted into the patient; wireless remote control device; And an implantable hydraulic reservoir hydraulically coupled to the implantable medical device and configured to be controlled by manually pressing the hydraulic reservoir. 15. An implantable lubricating medical device according to any of the preceding claims, comprising a system containing at least one of the group consisting of: an internal energy source for powering implantable energy-consuming components of the implantable medical device; internal energy receiver; configured to be powered in a non-invasive and wireless manner by a device for transmitting energy from outside the patient's body, wherein the energy transfer device is configured to send wireless energy to at least one of the group consisting of: an implantable internal energy source contained in said system, configured to be charged with energy transmitted from the energy transfer device, and at least one implantable energy-consuming component of said system, configured to be powered by wireless energy. 16. The implantable lubricating medical device of claim 15, comprising a system also comprising a sensor and/or measuring device for detecting or measuring at least one of the group consisting of: at least one physical parameter of the patient and at least one functional parameter related to the implantable medical device and including at least one of the group consisting of: a functional parameter related to energy transfer for charging the internal energy source, and a functional parameter related to the implantable medical device; wherein the implantable medical device also includes a feedback device for sending feedback data from within the patient's body to at least one of the group consisting of: implantable internal control unit; external control unit outside the patient's body; And an external control unit outside the patient's body, via an internal control unit; an external control unit from outside the patient's body, through the internal control unit in accordance with the programming of the internal control unit, which is performed by the external control unit; wherein the feedback data relates to at least one of said at least one physical parameter of the patient and said at least one functional parameter related to the implantable medical device.

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