KR20180090402A - Implantable Lubrication Device - Google Patents

Abstract

A lubrication apparatus for lubrication of joints of a human or mammalian patient which is fully implantable in a patient body, comprising a container for storing a lubricant and a fluid connection for introducing the lubricant into the joint when the device is implanted in a patient. In addition, the fluid connection includes a fluid connection device connecting the container to the joint, so that the flow of lubricant from the container into the joint is established. The fluid connection includes either an injection needle that is intermittently placed into the joint for injecting the lubrication fluid, or one of the tubes that is permanently positioned within the joint to continuously inject the lubrication fluid.

Description

[0001] Implantable Lubrication Device [0002]

The present invention relates to an implantable lubricating device, a lubricating system, and a method of treating a human or mammalian patient by the implantable lubricating system for softening joints of a human or mammalian patient.

The present invention is particularly suitable for introducing lubricant into the joints over a long period of time or periodically, for example, at fixed intervals or at long intervals over several years.

Lubrication (synovial fluid) reduces the friction between artificial cartilage and other tissues in the joints, and lubricates and absorbs the tissue components of the joints and bones in the noodles. In most cases of aging, and / or when the lubricant is negatively affected by excessive or abnormal stresses in human or mammalian joints (e.g., knee, hip joints), or joint articular cartilage covering the entire joint bone is damaged , It can lead to degenerative joint disease (also known as osteoarthritis), characterized by painful inflammation of the joints. When the composition of the lubricant is changed and pathologically reduced in joints consisting of adjacent bones and joint surfaces of the joints, which are wrapped and stabilized by the capsule and the capsular fluid, the lubricant is no longer in its normal role, the articular cartilage can not perform the lubrication action and the shock absorbing action of the joint part.

If the articular cartilage is severely impaired by osteoarthritis, and / or the ability of the articular sac to decrease or change its composition to reduce friction in the joints, the joint surface will be subject to high friction and increased Wear. This places considerable constraints on the behavior, especially on the walking or standing postures, which further increases the degenerative process of the joints. Degenerative arthritis is a very common disease in the western world, and it is becoming one of the major chronic disorders in Europe and the United States.

Patients with osteoarthritis require periodic long-term treatment, where the lubricant is introduced into the injured joint, which on the one hand restores the physical function of the damaged joint as much as possible and, on the other hand, On both sides, try to get as little external stress as possible.

A known standard therapy is to periodically inject a synthetic lubricant into the joint space by a syringe in vitro to replace nonexistent physiological lubricant. In such a conventional treatment, the patient has the inconvenience of delivering the lubricant to the inside of the joint through the skin and the joint capsule by the syringe at periodic time intervals. It can also cause scarring in the skin and the capsule, which increases the risk of serious infection of the sensitive joint tissue. Thus, infusion can not be performed more often than once every six months.

However, many patients require artificial infusion of lubricant more frequently, such as, for example, continuous artificial infusion of small amounts of lubricant.

Accordingly, the present invention is directed to proposing an improved technique for lubricating injured or worn joints of a patient or mammalian patient, while at the same time providing sufficient lubrication of the joints and, on the other hand, Is to suggest an improved technique.

The implantable lubrication apparatus includes, at a minimum, a container for storing the lubricant, and second, a fluid connection for introducing the stored lubricant into the damaged joint when the lubricator is implanted in a patient's body do. The lubrication apparatus can be completely implanted into the patient's body so that the damaged joint can be appropriately lubricated postoperatively from within the patient's body. This can significantly reduce the risk of infection for the patient and also allows for the postoperative supply of lubricant to the injured joints continuously, intermittently, periodically, or as needed, i.e., depending on the level of fluid in the joint.

An implanted lubrication system according to the present invention comprises an implanted lubrication apparatus and a lubricant contained in its container, which is introduced into the joint by its fluid connection.

More essential or optional components of the implantable lubrication device, such as a container, pump or motor, energy supply, control unit, etc., may also be completely implanted in the patient's body. Such components may belong to an implantable implantable device, or may form an integral part of an implantable lubrication system separate from the implantable implantable device. Since the implantable device can be implanted in the body of the patient as a whole, i. E., Providing both the function of storing the lubrication fluid in the patient ' s body and the function of transporting the lubrication fluid, In the body of. Thus, there is no need for injection into the joints outside the body.

The fluid connection includes a fluid connection device that connects the container of the implantable implant device to the joint, thus establishing a supply path for the lubricant from the container into the joint. The fluid connection is also completely implantable and therefore preferably consists of a flexible tube suitable for post-operative delivery of the lubricating fluid stored in the container to the joint.

In addition, the fluid connection portion includes an injection member connected to the fluid connection device. The injection member may be introduced into the patient's body at or very close to the joint during surgery, so that the lubrication fluid can be surgically introduced into the joint. It may be configured to inject lubricant into the joints periodically or intermittently, depending on the sensor data, and driven by the drive mechanism, if the level of lubricant falls below a predetermined limit. Alternatively and preferably, the injection member may also be configured to continually inject the lubricant into the joint, such as a predetermined amount of lubricant per unit time, e.g., one drop per hour, or the like.

Intermittent injection may be performed by an injection needle or the like placed close to the joint during surgery, so that it may progress intermittently in the forward direction to the inside of the joint by the driving mechanism, and then retracted Thereby enabling intermittent lubrication of the joints through the ends of the injection needle. The drive mechanism is configured to advance and retract the end of the injection needle into and out of the joint. The drive mechanism may be separate from the injection needle and / or fluid connection device, but it may be configured as part of the entire implantable lubrication device that is implanted entirely into the body of the patient.

Alternatively, the injection member may include an injection tube permanently secured within the joint to continuously introduce the lubricant into the joint. In this case, a separate drive mechanism for advancing and retracting the injection needle is not necessary, because the injection tube is made of a reasonably soft material that does not interfere with, or interfere with, the normal operation of the joint. Thus, the injection tube may be permanently in the joint, so that the lubricant can be continuously inserted into the joint space.

Preferably, the container of the implantable lubricating device may comprise a container connected to said fluid connection device for storing lubricant. Normally, the lubricant is stored in a container. The container may comprise a separate part of the implantable lubrication device, which is implanted independently into the patient ' s body. To establish an appropriate flow rate of lubricant into the joint, the container may be configured to vary its volume to form a suitable pressure in the injection member for transporting the lubricant into and into the fluid connection device.

Accordingly, at least a portion of the periphery of the container is adapted to change the volume of the container by deformation of the container flowable material as the lubricant is filled in or discharged therefrom, and wherein fluid flow from the container to the joint through the fluid connection device And a flowable outer wall for generating the fluid.

Thus, the container may be of the balloon type. The flowable material may comprise a polymer membrane. To reduce long-term performance degradation, a bellows structure with pre-folded corrugations is preferred. Drawing fluid out of the vessel into and out of the fluid connection will cause a pressure drop in at least a portion of the vessel so that it produces a negative pressure at the connection end of the fluid connection, . For example, the elongation may comprise a gas chamber or a fluid chamber, and the chambers may be separated by a membrane, for example polyimide, and thus act as a spring to change the volume of the vessel, The pressure in the gas chamber will decrease as the lubricant enters the fluid connection from the fluid chamber.

The container may also have a supplemental injection port for replenishing the lubricant into a container implanted from the outside of the human body. Thus, a container implanted in a patient body with a fluid connection device can be kept small in size because the container can be easily replenished at appropriate time intervals. Preferably, the infusion port comprises a self-sealing material for infiltration caused by an artificial infusion syringe that is primarily used to replenish the container through the patient ' s skin. It is desirable to implant the container of the lubrication device or at least to implant the self-sealing injection port of the container under the patient's side, and so that it can be easily replenished by the syringe means.

In order to introduce lubrication fluid into the patient's joint through the fluid connection device and the injection needle or injection tube, the container may be manually compressed, while the pump is connected to the fluid connection device, So as to pump the lubricant from the container into the joint. By means of the pump, an accurate dosage of the lubricant can be easily calculated, so that an appropriate amount of the lubricant can be fed into the joints in a continuous or intermittent manner.

The implantable pump preferably includes a valve device having first and second valve members, each of the first and second valve members defining a sealable contact between the first and second valve members , And having different fluid channels that can be arranged by deformation of two smooth surfaces relative to each other, while maintaining said sealing contact. This type of pump is described in great detail in WO 2004/012806 A1. The first and second valve members are preferably made of a ceramic material, for good long term sealability and durability to many elements. The pump may be a membrane type pump, which is also well described in WO 2004/012806 A1, but is not necessarily limited to this type. The membrane type pump may include a membrane that is moveable by movement of the piston, the piston being connected to the valve device such that as the piston moves, the first and second valve members are slidably displaced relative to one another .

Preferably, the manual drive of either the pump or the drive mechanism simultaneously drives the other, i.e., the drive mechanism or the pump. For example, the pressure applied by the pump can cause the drive mechanism to advance the injection needle when the injection fluid is delivered into the patient's body through the needle tip, and when the pressure is released by the pump, the return spring ) Or other resilient member will retract the injection needle.

The implanted pump may be driven by a mechanical remote control, or may be driven by a pressure sensitive switch arranged to be manually operable when subcutaneously implanted in the patient's body, or by measuring the level of fluid in the joint, And a drive mechanism for advancing and / or retracting the injection needle), and may also be driven by a sensor mechanism that drives the pump when the measured fluid level drops below a predetermined limit. Preferably, the driving of either the pump or the driving mechanism simultaneously drives the other, i.e., the driving mechanism or the pump. For example, the pressure applied by the pump can cause the drive mechanism to advance the injection needle when the injection fluid is delivered into the patient's body through the needle tip, and when the pressure is released by the pump, the return spring ) Or other resilient member will retract the injection needle.

At least one motor is provided to actuate a pump and, if used, a drive mechanism for advancing and / or retracting the injection needle into and out of the joint and, directly or indirectly, to flow the lubricant into the joint in the lubrication apparatus . The motor may be configured to operate the pump and / or drive mechanism, for example, electrically, magnetically, or electromagnetically, or may hydraulically operate the pump and / or drive mechanism. Preferably, the motor may be configured to drive one of a pump or a drive mechanism, such that the other one, i.e., the drive mechanism or pump, is driven at the same time. The motor may also be provided for operation of any other energy consuming portion of the injection device.

The term "motor" in the present invention uses energy other than the force applied manually and automatically converts such energy into kinetic energy, hydraulic energy, or another type of energy, or converts such energy into a pump, And / or any other directly used to activate other parts of the implanted lubricating device. Thus, in the case of the electromagnetically activated drive mechanism, the drive mechanism portion can also form part of the motor.

The motor forms part of the lubrication device and is detached from the lubrication device body for implantation in the patient's body and implanted into the patient's body or contained within the body of the lubrication device. A connecting member for providing electrical or radio energy to the motor from outside the apparatus may be provided. For example, the motor may be configured to be configured wirelessly by an external electromagnetic field. It is also possible to use an external energy source, such as a primary energy source or battery, especially a rechargeable battery, for use outside the patient's body, which is placed on the patient ' s skin and driven by a pump and / The energy can be supplied to any other energy consuming portion of the < / RTI > The energy source may be connected to at least the motor, in particular to activate the components. An external energy source for wireless energy transmission may be configured to form an external field, such as an electromagnetic field, a magnetic field, or an electric field, or to form a wavelength signal, such as an electromagnetic wave signal or an acoustic wave signal.

When the energy is transferred to the implanted lubrication apparatus wirelessly, an inverter for converting the energy transferred to the electric energy into the electric energy may be provided. Such a transducer is preferably arranged to lie directly beneath the skin of the patient so as to minimize the amount and distance of tissue between the transducer and the energy source member external to the patient's body.

An energy transfer device for transferring wireless energy from the energy source and / or energy storage member to the conversion device may be configured to form an electromagnetic field. Alternatively, or additionally, an energy delivery device for wireless energy transfer can be configured to form a magnetic field. In addition, an energy transfer device for wireless energy transfer can be configured to form an electric field. The wireless energy may also be transmitted by an energy delivery device with at least one wavelength signal. Such a signal may include an electromagnetic wave signal including at least one of an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma-radiation signal. In addition, the wavelength signal may include a sound wave or an ultrasonic signal. Further, the wireless energy may be delivered as a digital or analog signal or a combination thereof.

Instead of, or in addition to, the external energy source, the implantable lubricating device itself may be provided with an energy source. Such an energy source may be contained within the body of the lubrication apparatus, or it may be part of the body. However, it may be separate from the body of the lubricator so that it can be remotely implanted within the patient's body.

Such an implantable energy source may preferably comprise a long-term usable battery, or, more preferably, an energy source member such as an accumulator. The capacitor has the advantage that it can be recharged. Preferably, the capacitor includes a rechargeable battery and / or a capacitor.

A connecting member for transferring electrical or radio energy from the primary energy source to the capacitor from outside the device is also provided for charging the capacitor outside the patient's body when the device is implanted in the patient's body .

A driving member for manually driving the motor may be provided in the at least one motor, but a control unit for adjusting the at least one motor is also preferably provided. The control unit may be used to regulate any other energy consuming part of the pump, the drive mechanism and / or the implanted lubricating device, whereas if the device comprises an external or internal energy source, It can also be used to control. The control unit may be controlled according to the needs of each patient, and therefore an appropriate amount of medication will be administered at the appropriate time intervals. Automatic administration will substantially free the patient.

Preferably, the control unit has a data transfer port for transferring data between an external data processing unit external to the patient's body and a control unit implanted in the patient's body, the control unit being contained within the body of the lubrication apparatus Whether implanted in the patient's body or separated from the body of the implanted device. The data transfer port allows the control unit to supervise the injection device to apply to the changing needs of the patient. Advantageously, said data delivery port is a wireless delivery port for data delivery and thus provides for easy data conversion between said control unit and said data processing device, for example, while the patient meets a physician. Most preferably, the control unit can be programmed to further increase its application fluidity.

A control unit with or without a data transfer port may also be provided outside the body, such as on a patient's skin. The external control unit has an advantage that it can be easily accessed in the event of a failure. It is preferably applied for wireless remote control of at least one motor implanted with an injection device.

A control signal transmitting device for wirelessly transmitting a control signal in the outside of the body to the implanted motor may be provided. Similarly, a data transfer interface may be provided for wirelessly transferring data from outside the patient's body to a control unit implanted in the patient's body. Also, the transmission of the radio control signal and / or data may comprise one of the above-described wavelength signals, digital or analog, or a combination thereof. More preferably, the control signal can be communicated in the same manner that energy is transferred to the motor. For example, the control signal can be conveyed by modulating the energy signal, so that the energy signal can act as a carrier wavelength signal for a digital or analog control signal. More preferably, the control signal may be a frequency, phase, and / or amplitude modulated signal.

Aside from the control unit, or as part of the control unit, feedback on the parameters for the treatment of the patient can be provided. Such variables may be physical variables of the patient and / or processing parameters of the device. For this purpose, at least one feedback sensor is provided for detecting such a variable. For example, the feedback sensor may detect the level of the lubricant in the joint, or may detect other parameters of the joint and the condition of the lubricant. The feedback sensors may be connected to the control unit and the control unit may comprise an adjustment program for adjusting the delivery of the lubricant to the joints in response to the one or more signals of the feedback sensors. Additionally or alternatively, feedback data may be communicated from the control unit to an external data processing device. Such feedback data may be useful for physician diagnosis.

Preferably, the fluid connection device comprises two fluid connections each having an injection member connected to the container and at its end to be inserted into the joint space. The two fluid connections can be arranged in the patient's body so that they can be operated afterwards through a circulating flow path through the joint of the lubrication fluid, i.e., from the pump and / or the vessel to the joint (via the first fluid connection) And the return path (through the second fluid connection) to the pump and / or the vessel. Under pressure formed by the fluid outer wall of the pump or the container, the lubricant can circulate the circulating flow path intermittently or continuously, and the second fluid connection is capable of circulating the lubricant that has been inserted into the joint space by the first fluid connection Recall.

Because the circulating flow path causes the lubricant to pass through the joint at least partially and then reused, the lubricant is contaminated with impurities and other foreign matter that can reduce the desired effect and quality of the lubricant over time. Thus, the circulating fluid connection device of the implantable lubricating device may also include a filtration device having a filter connected into the circulating flow path to remove impure particles from the contaminated circulating lubricant. Preferably, the filtering device is configured to periodically clean the filter and also to remove particles that are filtered out of the lubricant. These removed particles or foreign matter may accumulate in the sealed storage space, or may be returned to the patient's body, such as surrounding tissues or blood vessels, and the like.

The lubrication device can be implanted in various locations on the patient's body and is preferably implanted as close as possible to the damaged joint to be lubricated. For example, the lubrication device, or a portion thereof, may be implanted in the thigh to lubricate the femur ball or knee. If the lubrication device, or its container, is relatively bulky, it is desirable to implant the container of the lubrication device completely, since it will be difficult to refill the container in the abdomen. However, in this case, a subcutaneous fill injection port connected through a tube to the vessel may be suitable. Alternatively, the lubrication apparatus may be implanted subcutaneously. Subcutaneous implantation increases the likelihood of radio energy and / or data transfer to or from the lubrication apparatus, if desired. In addition, when the lubricating device is implanted subcutaneously, it is also substantially easier to refill the container by recharging the injection port by the replenishing needle penetrating through the patient skin. Depending on the individual treatment, it may be advantageous to implant the lubrication device in or near the adipose tissue and thus the lubrication fluid may be injected into the particular joint.

Apart from the lubrication apparatus with the various components described above, the implanted lubrication system according to the present invention comprises a suitable lubricant liquid that is configured to be introduced into the joint by the fluid connection stored and implanted in the vessel. Preferably, the lubricant can be reabsorbed and, like the physiological lubricant, is bio-compatible to ensure reabsorption by biological and chemical interactions with the synthetic lubricant by the patient ' s body. Preferably, the lubricant is hyaluronic acid or the like.

In one aspect, an implantable medical device is configured to lubricate at least one artificial contact surface that carries a load within the joint when implanted in a human or mammalian body, the artificial contact surface comprising at least two contact surfaces, Wherein the medical device further comprises at least one outlet configured to receive a lubrication fluid from the container, wherein the medical device is configured to be operatively connected to the container And deliver it to the one or more artificial contact surfaces. The implantable medical device may include the container, and the spaced apart joints, and may include a conduit for fluid connection between the container and the joint.

The implantable medical device may be configured to lie within a cavity in an area within the patient's body selected from areas that are subcutaneous,

a. Abdominal region,

b. Groin area,

c. Pelvic area,

d. Thigh area.

Thus, the implantable medical device may be placed in the abdomen.

The fill injection port may be configured to be implanted subcutaneously, or connected to the bone.

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

The knee joint has inner and lateral contact load transfer surfaces and the implantable medical device can be configured to lubricate the artificial contact surface on the inner side of the knee of a human or mammalian patient.

Mammal joints have at least two contact surfaces. The medical device is configured to lubricate at least one of the articulating surfaces of the mammal within the joint, the at least one artificial contact surface replacing at least its surface. The medical device also includes at least one inlet configured to receive the lubricant from the container.

Usually, one or more channels are at least partially incorporated in the artificial contact surface, which is connected to one or more inlets for dispensing lubricant to the surface of the artificial contact surface. The medical device may be configured to be actuated by an actuating device to dispense the lubricant from the container. The possibility of injecting a lubricant fluid intermittently or as needed reduces the friction within the joint and also ensures the presence of an appropriate level of lubricant in the joint.

According to one aspect of the implantable medical device, the device may be configured to dispense lubricant on the surface of the artificial contact surface on at least two portions of the artificial contact surface to lubricate the artificial contact surface. Distribution at more than one point will allow a more even distribution of the lubricant.

According to yet another aspect of the medical device, the container configured to hold the lubricant may be an implantable container that is positioned in connection with the intracutaneous, subcutaneous, or bone of the body.

The implantable medical device further includes an actuating device configured to deliver lubricant from the container to the artificial contact surface for lubricating the artificial contact surface.

According to one aspect, the container can be configured to hold the lubricant, and the actuating device according to any of the aspects described so far can be configured to transport lubricant from the container to the artificial contact surface for lubricating the artificial contact surface . The actuation device may be electrically powered and configured to pump the lubricant from the container to the artificial contact surface for lubricating the artificial contact surface.

According to any of the embodiments described so far, the actuating device may comprise a pre-filled container with a compressed lubricant.

According to yet another aspect, an implantable medical device can be allowed to pre-fill the container with a pressurized lubricant, by injection into the injection port.

According to one aspect, the implantable medical device may further comprise a valve configured to bring the connection between the container and the artificial contact surface into closer proximity. The container may be configured to lie within a unit that is independent of the artificial contact surface and may be configured to be connected to the artificial contact surface by a conduit. The container may include a movable wall portion configured to move and change the volume of the container, and the wall portion may be a motor driven wall portion that may include a motor.

According to another aspect, an implantable medical device may include at least one additional channel and at least one inlet that is at least partially integrated within the artificial contact surface. The medical device may be configured to permit circulation of lubricant from the artificial contact surface through the outlet and into the artificial contact surface through the inlet. The circulation of the lubricant may be performed by an operating device configured to circulate the lubricant. The circulation system may include a container configured to add lubricant to the circulating lubricant, and / or a filter to clean the circulating lubricant.

The actuating device according to any of the above aspects can be configured to intermittently transport lubricant to the artificial contact surface.

An implantable medical device in accordance with an embodiment senses physical parameters within the joint, or volume or pressure of the lubricant, or functional parameters of the actuator for adjusting the actuator to adjust the flow of lubricant to the artificial contact surface And may include sensors that are adapted to do so.

The container according to any of the above aspects may be connected to the artificial contact surfaces through the conduit. The inlet may include a connection for connecting the conduit to any portion of the medical device. The conduit according to any of the above aspects may comprise a plurality of portions, which may be configured to be connected to one another via an internal connection. A first portion of the conduit may be connected to the medical device, and a second portion of the conduit may be coupled to the container. The conduit according to any of the above aspects may be adapted to pass through the bones of the body for long term maintenance of the open passageway through the bone, such that the lubricant reaches the artificial contact surface. According to yet another aspect, the conduit may be adapted to pass through the body's capsule for long term maintenance of a passageway open through the capsule, such that the lubricant reaches the artificial contact surface, and according to another aspect, May be adapted to connect from the opposing acetabulum through the pelvic bone into the high septum.

The implantable medical device may be adapted to lubricate the patient's hip, wherein the artificial contact surface of the medical device may be configured to at least partially replace the contact surface of the acetabulum and / or the caput femur .

An implantable medical device according to an embodiment lubricates a second artificial contact surface. According to one aspect, the first artificial contact surface includes a convex structure toward the hip joint center, and the second artificial contact surface includes a concave structure toward the center of the hip joint. The first artificial contact surface according to this opposite aspect is adapted to be fixed to the pelvic bone of a human patient, and the second artificial contact surface is adapted to be fixed to the femur of a human patient. The artificial contact surface may be adapted to be introduced from the abdominal side of the pelvic bone into the hip joint through a hole in the pelvic bone, and the surgical method can maintain the articular capsule fully.

In another embodiment, the container is configured such that the interior or at least a portion of the patient's bone is located internally, and the bone may be, for example, the patient's femur, pelvic bone, or collum femur.

According to yet another aspect, the container may be adapted to be located in or subcutaneously in the body, and the steel may be a steel in a region selected from a region consisting of abdomen region, crotch region, pelvic region, have.

An implantable medical device in accordance with an aspect includes an injection port for filling a container. The injection port may include a self-sealing film, which may be, for example, a Parylene-coated silicon film. The injection port may be configured to be implanted subcutaneously, connected to the bone, or into the body's body of steel.

The vessel may be configured to maintain the lubricant under pressure. To achieve this pressure, the vessel may be configured to be loaded with a spring and may include a chamber configured to hold the compressed gas or an elastic wall adapted to generate pressure. According to one embodiment, the container comprises a parylene coated silicone elastic wall.

According to another aspect, an implantable medical device is configured to lubricate a patient ' s knee. According to one aspect, the artificial contact surface to be lubricated is configured to at least partially replace the contact surface of the femur, which may be the contact surface of the tibia and / or the femur.

According to one aspect, a medical device is adapted to lubricate in at least one of an inward or lateral portion of a tibial contact surface of a knee joint, according to another aspect, the implantable medical device includes an inward or lateral / RTI > of at least one of the portions. According to another aspect, the medical device is adapted to lubricate both the contact surface of the femur of the knee joint and the contact portion of the shin bone of the knee joint.

According to one aspect, the container according to any of the above aspects is configured to be refilled from the outside of the human body, and the re-introduction can be performed through an implantable injection port.

According to one aspect, the vessel is adapted to maintain pressure, which may increase the pressure through the injection of lubricant through the inlet port.

According to any of the above aspects, the implantable medical device may be configured as part of a system that further comprises at least one switch implantable within the patient for controlling the implantable medical device in a manual and non-surgical manner . The energized system may cause the actuating device to actuate the lubrication performed by the medical device.

The system according to one aspect further comprises a hydraulic device having an implantable hydraulic container, which may be hydraulically connected to the implantable medical device. The implantable medical device may be configured to be non-surgically adjusted by manually pressing the hydraulic container.

According to yet another aspect, the system may further comprise a wireless remote controller for non-surgical adjustment of the implantable medical device. The wireless remote controller may include at least one external signal transmitter and / or container, and may also receive signals transmitted by the external signal transmitter, or may be implanted in a patient to deliver the signals to an external signal receiver. And may further include a possible internal signal receiver and / or transmitter. The wireless remote controller may also be configured to deliver at least one radio control signal for conditioning the implantable medical device. The radio control signal may comprise a frequency, amplitude, or phase modulated signal or a combination thereof. The wireless remote controller may also be configured to transmit an electromagnetic carrier wave signal for conveying the control signal.

According to yet another aspect, the system may include a wireless energy delivery device for non-surgically energizing the implantable energy consuming components of the implantable medical device by wireless energy. The wireless energy may be at least one of an acoustic signal, an ultrasonic signal, an electromagnetic wave signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser light signal, a microwave signal, a lidar wave signal, And may include a wave signal selected from an electrical and magnetic field.

The control signals in the system may include electric fields, magnetic fields, combined electrical and magnetic fields. The signal may comprise an analog signal, a digital signal, or a combination of analog and digital signals. In order to power the energy consuming components of the implantable medical device, the implantable system may include an implantable internal energy source. According to another aspect, the system includes an external energy source for delivering energy in a wireless mode, wherein the internal energy source is charged by energy delivered in a wireless mode.

According to yet another aspect, the system includes a measurement device or sensor that measures or senses a functional parameter associated with transfer of energy for charging the internal energy source, and a feedback device for transferring feedback information from within the patient to the outside of the patient. And the feedback information may be related to functional parameters measured by the measurement device or sensed by the sensor.

According to yet another aspect, the system further comprises a feedback device for transmitting feedback information from within the patient to the outside of the patient, said feedback information comprising at least one of functional parameters associated with the implantable medical device and physical variables of the patient .

According to one aspect, the system comprises a sensor and / or a measuring device, and information relating to at least one of the physical variables of the patient as sensed by the sensor or measured by the measuring device, And an implantable internal control unit for controlling the implanted medical device in response to functional parameters associated with the implantable medical device as measured by the device. According to one embodiment, the physical variable may be pressure or motility movement.

According to one aspect, the system may comprise an implantable internal data communicator in communication with an external data communicator and an external data communicator, the internal communicator supplying data to the external data communicator, associated with the implantable medical device or patient, And / or the external data communicator supplies data to the internal data communicator.

According to one aspect, the system may further comprise a motor or pump for operating the implantable medical device, and a hydraulic actuation device for operating the implantable medical device. The operating device is preferably a servomechanism designed to reduce the force required for the operating device to actuate the implantable medical device, rather than performing the longer method of increasing the time for the predetermined operation, and a servo mechanism.

According to one aspect, the system may further comprise an operating device for operating the implantable medical device. In order to power the operating device directly to generate kinetic energy for the operation of the implantable medical device, the wireless energy may be used in a wireless state because the wireless energy is transmitted by the energy-transfer device. The system may also include an energy-conversion device for converting the radio energy delivered by the energy-transfer device from a first type to a second type of energy.

The energy-conversion device is characterized in that as the energy-conversion device converts the energy of the first type transferred by the energy-transfer device into energy of the second type, the implantable energy- The power can be directly supplied by the energy of the power source. The second type of energy comprises at least one direct current and oscillates the direct current and alternating current regularly. The energy of the first and second forms may be selected from the group consisting of magnetic energy, kinetic energy, sonic energy, chemical energy, radiation energy, electromagnetic energy, light energy, nuclear energy, heat energy, non- non-nuclear energy, non-kinetic energy, non-chemical energy, non-sonic energy, non-nuclear energy, and non- .

To protect portions of the system or system, the system may further include implantable electrical components including a guard of at least one volt level and / or a guard of at least one constant current. The control device may be configured to regulate the transfer of radio energy from the energy-transfer device and the implantable internal energy receiver for receiving the delivered radio energy, the internal energy receiver being capable of implanting the received energy Connected to implantable energy-consuming components of an implantable medical device for direct or indirect delivery to a medical device, the system comprising: means for receiving energy received by the internal energy receiver and implantable energy consumption of the implantable medical device The determination device may further comprise a determination device configured to determine an energy balance between the energy used for the components and the control device is configured to determine the energy balance of the energy of the wireless energy from the external energy- And may be configured to regulate delivery.

The determination device may be configured to detect a change in energy balance and the control device may be configured to adjust the delivery of wireless energy based on the detected energy balance change. The determining device may eventually be configured to detect a difference between the energy used by the implantable energy consuming components of the implantable medical device and the energy received by the internal energy receiver, And can be configured to control the delivery of wireless energy based on energy differences.

The energy-transfer device may comprise a coil located outside the human body, the coil being connected to an implantable energy receiver to be located within the human body and to an external coil having an electrical pulse to deliver radio energy Further comprising an electrical circuit, said electrical pulse having leading leading edges, said electrical circuit having a first time interval between consecutive leading and trailing edges of electrical pulses, The energy receiver is adjusted to vary the power of the transmitted wireless energy by varying a second time interval between going and preceding edges, and the energy receiver receiving the transmitted wireless energy has a changed power. The electrical circuit may be configured to deliver the electrical pulses unchanged, other than changing the first and / or second time intervals.

According to one aspect, the system has an electric circuit having a time constant configured to vary first and second time intervals that are only in a range of a first time constant, and thus the first and / The power transmitted to the coil changes.

An implantable internal energy receiver for receiving radio energy may include an internal first coil and a first electrical circuit coupled to the external coil for transmitting radio energy and an external energy transfer device, 2 coil and a second electrical circuit coupled to the second coil, wherein an external second coil of the energy transferor receives radio energy received by the first coil of the energy receiver, Further comprising a power switch for switching the connection of the inner first coil to the first electric circuit on and off so that the feedback information associated with charging the first coil is such that the power switch is connected to the inner coil When the connection of one coil to the first electric circuit is switched on and off, a change in impedance of the first external coil under the load of the external second coil Lt; / RTI > is received by an external energy transmitter.

The system also includes an internal energy receiver having an internal first coil and a first electrical circuit coupled to the first coil, an external energy transducer for transferring wireless energy, And an external energy transmitter including an external second coil and a second electrical circuit coupled to the second coil, wherein the external second coil of the energy transferor is coupled to a first coil of the energy receiver Wherein the system further comprises a feedback device for communicating an amount of energy received at the first coil as feedback information, wherein the second electrical circuit is operable to transmit the feedback information And the amount of energy delivered by the second coil to the amount of energy received at the first coil In comparison with the feedback information includes a determination unit for obtaining a coupling coefficient between the first coil and the second coil.

In an embodiment wherein the system includes an external second coil, the external second coil may be configured to move relative to the internal first coil to establish an optimal position of the second coil, wherein the coupling coefficient is maximum to be. The external second coil may also be adapted to obtain feedback information in the decision apparatus by correcting the amount of energy transferred before the coupling coefficient is maximized.

According to a second aspect, a method of delivering a medical device according to any of the aspects described above is also provided. The method comprising the steps of: forming an opening in the joint from outside the human body, providing an artificial contact surface to the joint, securing the artificial contact surface to the joint, implanting the container in the human body, The artificial contact surface is lubricated using the lubricant contained in the container.

The step of lubricating the artificial contact surface or the articular contact surface using the lubricant contained in the container may comprise implanting an actuating device configured to transport the lubricant from the container to the artificial contact surface. According to another aspect, lubrication of the artificial contact surface using a lubricant contained in the vessel includes providing an energy source for powering the actuation device.

According to yet another aspect, the method may include powering the actuation device using the energy source with an artificial contact surface or a joint contact surface using a lubricant contained in the container.

According to one aspect, implanting a container in a human body comprises implanting an operating device coupled to the container, by using the operating device to transport the lubricating fluid from the container to the artificial contact surface, Allowing the step of lubricating the artificial contact surface with the lubricant contained in the vessel.

According to any of the aspects described above, implanting the vessel comprises implanting the vessel at least partially into the bone of the patient, wherein the bone comprises the patient's femur, the patient's shin bone, and / Patients may have pelvic bone.

Providing the artificial contact surface may include providing the artificial contact surface from the abdominal side of the pelvic bone.

The step of implanting the container within the human body may include subcutaneously implanting the container. Subcutaneous positioning of the container permits simple access to the container and eliminates the need for a long conduit between the container and the injection port.

The subcutaneous implantation of the container may comprise implanting the container in one or more of the areas of the patient selected from the areas consisting of the abdomen area, the groin area, the pelvis area, the thigh area, and the calf area.

An additional step of implanting an injection port for filling the vessel may be performed. The implantation of the implantation port may include implanting the implantation port in connection with the bone.

According to one aspect, the medical device includes an artificial contact surface configured to transmit a load to a joint of a patient, the artificial contact surface including at least one lubricant transport channel, the method comprising the steps of: Implanting the medical device into a joint of a human patient, implanting a conduit configured to be connected to the medical device, implanting an actuating device for delivering lubricant into the conduit, Implanting a container to hold the lubricant, and transporting the lubricant through the channel in the artificial contact surface from the container to the artificial contact surface and further in the conduit, at least postoperatively by the operating device, Applying to the artificial contact surface.

Generally, lubrication devices can be implanted during conventional surgical or endoscopic or laparoscopic surgery. On the other hand, it is necessary to differentiate between a method of implanting a lubricating apparatus having an injection needle for intermittent introduction of a lubricant and a method of implanting a lubricating apparatus having an injection tube for continuous introduction of a lubricant.

In a method for treating osteoarthritis of a human or a mammal, e.g., a human hip or knee, by providing a lubricant to the joint by implantable lubrication device means, a suitable location including the joint site of the patient's body by surgery Is performed, which may include, inter alia, cutting the skin of the patient to incise the position where the container is suitable for storing the lubricant. Thereafter, the lubrication apparatus is placed in a proper open position so that the fluid connection can introduce a lubricant into the joints after the operation. For this purpose, one hole is created in the joint capsule in the incised open area of the joint, and an injection tube is introduced into the hole to inject the lubricating solution stored in the container into the joint continuously after surgery, So that the open end of the joint is continuously connected to the joint. That is, the injection tube is first kept in a state in which the open end of the injection tube is in a state of permanently communicating with the joint to be lubricated, and second, the injection tube is in contact with the fluid connection device, . After the positioning of the lubrication device is confirmed, the patient's body is closed so that the lubrication device is entirely implanted in the patient's body. This process can preferably be performed in layers by an operating room or staple, or an adhesive. Finally, after the grafting procedure, the lubrication fluid is introduced into the vessel postoperatively so that the joints are adequately lubricated by the operation of the implanted lubrication apparatus.

Alternatively, if the fluid connection includes an infusion needle that operates intermittently as an infusion member, positioning of the lubrication apparatus in the appropriate open position and joint region of the incision may be achieved by positioning the infusion needle in an incised region of the joint So that the driving mechanism of the injection needle can intermittently introduce and retract the injection needle into and out of the joint, thereby positioning the lubrication fluid stored in the container so as to be intermittently injected into the joint. That is, the injection needle is located close to the open area of the joint so that it can be intermittently introduced into the joint to lubricate the joint, and then can be retracted by a suitable drive mechanism connected to a drive mechanism or the like.

Another method of treating a human or mammalian patient with an implantable lubricator utilizes endoscopic or laparoscopic surgery to create an articulating region through which the lubricant can be injected into the joint by the injection member. This region of the joint first expands the steel at a location close to the joint by inserting a needle or tube device into the patient's body and introduces gas through the needle / tube device to fill the tissue with gas , Thus extending the river near the joint. Thereafter, at least two laparoscopic / endoscopic trocar are placed into the river, and the camera and at least one incision instrument are inserted through the laparoscopic trocar. The joint region is then incised using the inserted incision opening. In addition, suitable positions for the remaining parts of the lubrication apparatus, e.g., vessel, pump or motor, are cut open. The lubrication device is then placed in the proper position so that the fluid connection with the injection member is placed in the laparoscopically incised joint region so that the lubrication fluid is introduced into the joint. After positioning the lubrication device, the patient body is closed with the effect that the lubrication device is entirely implanted into the patient's body. Thereafter, the lubricant is introduced into the container postoperatively, and the joint is properly lubricated through the fluid connection device and the injection member.

Also by using the laparoscopic method, a lubrication apparatus having an injection tube or an injection needle can be implanted. In the former case, the container is placed in the proper position, a hole is formed in the capsule in the area incised by the laparoscope of the joint, and the injection tube is inserted into the hole so that the open end of the tube is in communication with the joint And the stored, stored lubricant can be continuously injected into the joint. In the latter case, after locating the container in the proper position, the injection needle and drive mechanism are placed close to the joint region which is cut by the laparoscope, so that the drive mechanism can introduce the injection needle into the joint (and out of the joint) So that the stored lubricant can be injected intermittently into the joint.

Covering the patient's body, or especially the skin, may include, for example, suturing, taping, and other suitable techniques. The lubrication device may be positioned subcutaneously within the patient's body, within the adipose tissue, or within the muscle. If appropriate, the lubrication device may be placed in or near the patient's digestive tract or urinary tract. If it is placed near the tubes, it could be fixed to the digestion-bowel or urine tube by a holder connected to the lubrication device. As a further alternative, the lubrication device may be located in the chest of the patient or in the abdomen of the patient. For example, the container may be positioned within the abdominal cavity or thoracic cavity. Alternatively, a portion thereof, such as a lubrication device or a container, may be implanted by open surgery, wherein the thoracic or abdominal wall is open to position the lubrication device at a suitable location in the patient's chest or abdomen, The posterior skin and other layers of tissue are closed by a method such as suturing, which is preferably sutured together. Recharging of the vessel preferably includes injecting an amount of lubricant around the vessel, for example, through an inlet port integrated and / or connected to the vessel.

A functional hip joint motion will be understood as the movement of the hip joint at least partially corresponding to the natural motion of the hip joint. In some cases, the natural motion of the hip may be somewhat limited or altered after hip surgery, which would make the functional hip motion of the hip with artificial surfaces somewhat different from the functional hip motion of the natural hip .

The functional location of the implantable medical hip arthroplasty or implant is the location where the hip can perform functional hip joint motion. The final position can be understood as a functional position where the medical instrument does not need to change position anymore.

The movement of the functional knee should be understood as the movement of the knee at least partially corresponding to the natural movement of the knee. In some cases, the natural movement of the knee may be somewhat limited or altered after the knee surgery, which will enable the functional knee movement of the knee by a slightly different artificial surface than the functional knee movement of the natural knee .

The functional position of the implantable medical knee instrument or implant is the position at which the knee joint can perform functional knee movements.

A functional knee joint is a knee joint capable of performing functional knee movements, with or without a medical instrument or insert with a knee inserted.

The overall functional size should be understood as the size of the medical knee apparatus when the medical knee apparatus is implanted in the knee.

Arthroscopy should be understood as a key hole operation performed on the knee, which can be performed in the abdominal cavity of the patient, and some of the steps of the arthroscopy can be performed Although performed laparoscopically, for purposes of the present invention, the two terms arthroscopy and laparoscopy are used analogously, and for the purposes of the present invention, the primary purpose of these methods is that they are minimally invasive.

The medical device according to any of the above aspects comprises at least one material selected from the group consisting of: polytetrafluoroethylene (PTEE), perfluoroalkoxy (PEA) and fluorinated ethylene propylene (FEP ). Materials comprising cobalt-chromium-molybdenum or a metal alloy such as titanium or stainless steel, or polyethylene such as cross-linked polyethylene or gas sterilized polyethylene may be more reliable. The use of ceramic materials in the artificial contact surfaces or in the entire medical device such as zirconium or zirconium dioxide ceramics or alumina ceramics is also reliable. A portion of the medical device in contact with the human bone for securing the medical device to the human bone may be a porous micro or nanostructure that is applied to promote the growth of human bone in the medical device for immobilization of the medical device And a poorhouse structure. The porous structure can be achieved by applying a hydroxy-apatite (HA) coating, or a coarse open pore titanium coating, which can be produced by air plasma spraying, and the titanium coating of coarse open pores and the HA surface layer Can also be trusted. The contacting portion may be comprised of a self-lubricating material such as a waxy polymer such as PTFE, PEa, FEP, PE or UHMWPE, or a powdered metal material into which a lubricant may be injected, which is preferably biocompatible, such as a hyaluronic acid derivative It is a lubricant. It is also preferable that the material on the surface or the contact portion of the medical device according to the invention is configured to be lubricated uniformly or intermittently. According to some embodiments, the parts or parts of the medical device may comprise a combination of metal material and / or carbon fiber and / or boron, a combination of metal and plastic materials, a combination of metal and carbon based materials, a combination of carbon and plastic based materials , A combination of flowable and rigid materials, a combination of elastic and low-elastic materials, Corian or acrylic polymers.

It is noted that any aspect or portion of an aspect, and any method or portion of a method, may be combined in any manner. All of the embodiments described herein are shown as a part of the generic description, and thus can be combined in any way in generic terms. It is also to be understood that the description herein generally describes both apparatus and methods.

The various features of the aspects may be combined in any manner so long as such combinations are not explicitly contradictory to each other. Embodiments will now be described in more detail with reference to the accompanying drawings. Also, each feature of the various aspects will be combined or interchanged with each other, unless such combination or exchange is clearly contradictory to the overall functionality of the device.

Figure 1 shows the body of a patient with an implanted lubrication device for lubrication of the hip and / or knee joint.
Figures 1A and 1B show the hip and knee joints of Figure 1, respectively, and have injection members of the implanted lubrication device inserted therein.
1C shows a side view of the knee when a medical device is provided.
1D shows a cross-sectional view of a medical device according to an aspect.
1E shows the major components of the implanted lubrication apparatus.
1F shows a motor-driven implanted lubrication apparatus for establishing a circulating flow path.
Figure 2A shows an implanted lubrication apparatus with a drive device and an injection needle.
Fig. 2B is a diagrammatic representation of the lubrication apparatus of Fig. 2A with some modifications.
Figure 2C shows a cross-sectional view of the component aspect of the implanted lubrication apparatus.
Figure 2D shows a motor-driven pump unit suitable for use in connection with the embodiment shown in Figure 1F.
Figure 3 shows a medical device according to one aspect comprising an artificial contact surface.
Figure 4 shows a cross-section of a medical device according to one aspect comprising an artificial contact surface.
5 is a front view of a human patient showing a hip joint.
6 is a side cross-sectional view of a human patient when performing a laparoscopic / arthroscopic examination procedure.
Fig. 7 shows a hip joint portion when a small hole is formed in the pelvic bone.
8A shows the hip joint portion when a small hole is formed in the pelvic bone.
Figure 8b shows a cross section of the hip joint when the medical device is provided through a hole in the pelvic bone.
Figure 9a shows a cross section of the hip joint when a medical device is provided through a hole in the pelvic bone.
Figure 10 shows a cross section of a hip joint provided with a medical device connected to an implantable lubrication system.
11A-C show a surgical instrument for use in a method of providing a medical device according to any of the aspects described above.
Figure 12 shows a cross section of a hip joint with the medical device being implanted and connected to an implantable container.
13A shows a side cross-sectional view of the hip joint when a hole is formed through the femur.
13B shows a cross section of the hip joint when a medical device is provided through a hole formed in the femur.
13C shows a cross section of the hip joint when a medical device is provided through a hole formed in the femur.
Figure 13d shows the container configured to be connected to the medical device in more detail.
Figure 14 shows the injection of lubricant into the implantable injection port.
15 shows an implantable medical device in an opposite embodiment.
16 shows a portion of the hip joint when the implantable medical device is positioned in the opposite embodiment.
Figure 17 shows the hip joint portion when the implantable medical device is positioned in the opposite embodiment.
Figure 18 shows the hip joint portion when the implantable medical device is positioned and connected to the container in an opposite embodiment.
Figure 20 shows a front view of a knee of a human patient provided with a medical device.
Figure 21 shows an implantable lubrication system.
Figure 22a shows a side view of the knee when a medical device is provided to the femur.
Figure 22B shows a side view of the knee when a medical device is provided to the shin bone.
Figure 23 shows a medical device comprising an artificial knee joint surface.
Figure 24 shows a medical device comprising an artificial knee joint surface.
Figure 25a shows a medical device comprising multiple medical device parts.
Figure 25b shows the assembly of a medical device including multiple medical device parts.
Figure 26 shows a medical device when the medical device comprising multiple medical device parts is secured to the shin bone.
Figure 27 shows the shape of an implantable medical device according to one embodiment when secured to a shin bone and connected to a container and an injection port.
Figure 28 shows a front view of an intermittent patient provided with an implantable infusion system.
29 shows the implantable lubrication system in more detail.
30 shows in more detail an implantable circulating lubrication system.
Figure 31 shows an implantable circulating lubrication system including a filter in more detail.
32 shows an implantable lubrication system for lubrication of a hip joint surface.
Figure 33A shows a first state of an implantable lubrication system including a retractable needle.
Figure 33B shows a second state of the implantable lubrication system including a retractable needle.
34 shows a system for treating a disease, comprising a system of the present invention implanted in a patient.
35-49 schematically illustrate various aspects of a system for wirelessly powering the device shown in Fig.
Figure 50 is a schematic block diagram illustrating the supply structure of an appropriate amount of energy used for operation of the apparatus shown in Figure 34;
Figure 51 schematically illustrates an aspect of the system, wherein the device is an energy-operated device that is carried by a wire.
Figure 52 is a block diagram illustrating in greater detail the arrangement for controlling the transfer of radio energy used for operation of the apparatus shown in Figure 34;
53 is a circuit for the configuration shown in Fig. 52, according to an embodiment capable of being performed.
Figures 54-60c illustrate various methods of providing a hydraulic or pneumatic energy delivery system for a patient.

Hereinafter, preferred embodiments will be described in detail. In the drawings, like reference numerals designate the same or corresponding elements in several views. It is to be understood that these drawings are for the purpose of illustration only and are not intended to limit the scope of the invention in any way. Thus, all references to directions such as "above" or "below " In addition, any direction shown in the figures is for illustrative purposes only.

It should be noted that any method or method as well as some embodiments or portions of the method may be combined in any manner. All examples herein are to be regarded only as a part of the general description, and thus are generally combinable in any way.

1 shows a body of a patient to which a lubrication apparatus is implanted, which is composed of a body 1401 and two fluid connection tubes 1402 for transporting joints to lubricate the lubricant stored in the storage unit, here, the hip joint and the knee joint will be. Thus, the main body 1401 includes a reservoir for storing the lubricant, and may also include additional components such as a pump, a motor, and a control unit. The entire implant can be implanted in the patient so that the joints can be adequately softened, independent of the lubrication device, i.e., all of its components, any external components, or implants that significantly reduce the risk of infection of the patient . Depending on the type of joint and the severity of the joint damage, the joint may be lubricated intermittently / periodically, continuously or as needed, e.g., depending on the level of lubricant within the joint. In general, the main body 1401 of the lubrication apparatus can be implanted subcutaneously so as to be easily accessible, for example, via a radio control unit or the like, so as to easily recharge the storage unit or set the operation mode or function.

In Figs. 1A and 1B, the two lubricating liquids shown in Fig. 1 are treated with the joint, hip and knee respectively in more detail. 1A and 1B, the fluid connection tube 1402 includes an injection member at the distal end, which is inserted into the joint space and eventually causes the lubricant to flow into the joint. 1A shows an injection needle 1403 that is passed through a joint capsule and is injected into the joint space of the hip joint. The injection needle 1403 may enter and exit the joint space in association with a drive mechanism (not shown) for intermittently treating the joint with the lubricant. As another example, in FIG. 1B, the injection member is an injection tube 1404 that is permanently disposed in the joint space so that a continuous flow of lubricant can reach the joint. The material of the injection tube 1404 may be a flexible material that does not interfere with the joints or minimize interference when performing a given operation. A driving mechanism is not required for the injection tube 1404 of Fig. 1B.

In general, there are two traditional methods of implanting a lubrication apparatus, namely, a conventional method of disposing an injection needle 1403 or an injection tube 1404 in a non-incision region without incising the joint region, And a laparoscopic method in which the injection needle 1403 or the injection tube 1404 is placed in the intramuscular cavity through the laparoscopic trocar. When the fluid connection pipe 1402 ends at the injection needle 1403 as shown in FIG. 1A, the injection needle 1403 is moved in the direction of the arrow A in such a manner that the driving mechanism of the needle is moved in and out of the joint space In a manner such that the injection needle 1403 can be inserted and withdrawn intermittently, in the vicinity of the joint capsule or in the hole in the capsule. As another example, if there is an injection tube 1404 at the end of the fluid connection tube 1402, as shown in FIG. 1B, a permanent hole is made in the joint capsule in which the tube is continuously positioned, so that the lubricant can be continuously injected into the joint I make it.

Figure 1C shows a medical device according to one embodiment, wherein the medical device includes a first artificial contact surface 1101 that can replace the distal surface of the femur 102 that is part of the knee joint. The first artificial contact surface 1101 can replace both the surface of the lateral condyle, the surface of the medial condyle, or both the lateral and medial articular bumps. The medical device of FIG. 1C further includes a second artificial contact surface 1102 that can replace the contact surface of the shin bone, which is another contact surface of the knee joint. The implantable medical device includes an inlet 1104 through which a lubricant can be supplied from the reservoir 1108. In this embodiment the inlet is located on the trailing side of the shin bone 102 and on the trailing side of the femur 102 Respectively. The reservoir 1108 can be charged by means of an injection port 1107 arranged in fluid contact with the reservoir 1108 in this embodiment. The reservoir 1108 provides lubrication fluid to the inlet 1104 (1123) through a conduit 1106 that provides fluid flow between the medical device and the reservoir 1108. When the reservoir 1108 is filled through the injection port 1107, the reservoir is connected to the reservoir 1108 through the injection port 1108, which includes a chamber for pressurized gas to be further compressed, under pressure . The inlet 1104 (1123) transports lubricant to the channel 1105, which is at least partially integral with the artificial contact surfaces 1101, 1102. In the embodiment of FIG. 1, channel 1105 is fully integrated into the medical device. The channel 1105 supplies lubricant onto the artificial contact surfaces 1101 and 1102 so that the artificial contact surfaces 1101 and 1102 are softened and the friction is reduced thereby improving its functionality. Implantable medical devices may of course also be implanted in the knee of other mammals such as horses.

FIG. 1D shows an implantable medical device according to an embodiment in which the medical device can replace a portion of the hip joint. The medical device includes a plurality of channels 1105 that can lubricate the artificial contact surface of the hip joint by a lubricant injected into the channel through a conduit 1106 located in the center of the implantable medical device. A conduit 1106 is disposed in fluid communication with a plurality of channels 1105 of a storage portion 1108 located in a stem portion of the medical device that is capable of securing to the femur of a human patient . The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105. In the storage portion 1108 according to the embodiment of FIG. 1D, a spring is installed with a spring 1109 pushing a movable wall portion in the form of a piston 1110 to pressurize the lubricant. The reservoir 1108 may be charged through an injection port 1107 disposed on the side of the medical device. The injection of the lubrication fluid through the injection port 1107 causes the spring 1109 to compress and apply pressure to the lubrication fluid which pushes the lubrication fluid through the conduit 1106 and again lubricates the human patient's hip And pushes it to the channel 1105. The spring provided in the reservoir 1108 may be any other type of reservoir capable of exerting pressure on the lubrication fluid, such as a reservoir 1108 including a chamber filled with a pressurized gas that is further pressurized by injecting a lubrication fluid through the injection port And the storage portion 1108 may be an elastic storage portion when the elastic property of the elastic storage portion pressurizes the lubricant.

1E shows an implanted lubrication apparatus and its major components. The lubrication apparatus of FIG. 1E includes a reservoir R for storing a lubricant, an infusion tube 1404 in which an open end is permanently positioned in the joint space, a fluid connection tube 1402 for connecting the reservoir R, . A gas chamber 1407 capable of generating a pressure necessary for volume expansion is formed through the fluid connection tube 1402 and the injection tube 1404 so as to form a suitable pressure to press the lubricant in the joint from the reservoir R , And is disposed inside the storage unit R. Since the fill injection port 1406 disposed on the outer wall of the reservoir R is accessible through the skin 1405 of the patient, the lubricant is stored in the reservoir R by the syringe being scanned through the patient skin 1405, The storage unit is subcutaneously implanted. The fill injection port 1406 can thus be made of a suitable film, e.g. a polymeric material, which is self-sealing against penetration of the injection syringe.

1F shows another example of the lubrication apparatus according to the present invention. The pump P driven by the motor M has a structure in which the reservoir R is divided into two tube portions 1402a and 1402b, which form a sufficient circulating flow passage of the lubricant through joints lubricated with the reservoir portion R. [ 1402b of the circulating fluid connection pipe 1402. [ Each of the two tube portions 1402a and 1402b includes individual injection tubes 1404a and 1404b that are inserted into the joint space and the lubricant stored in the storage portion is passed through the tube portion 1402a through the injection tube 1404a The lubricant that is introduced into the joint space and used at the same time is provided with a filter 1428 disposed within the flow passage partially defined by the tube portion 1402b via the tube portion 1402b through the injection tube 1402b Passed through the filter device 1427, and returns from the joint to the storage part. The lubricant is continuously circulated in the circulating flow passage formed by the fluid connection pipe portions 1402a and 1402b so that at least a part of the lubricant can be reused even after the lubricant has passed through the joint under the pressure generated by the pump P. However, in order to be able to reuse the lubricant discharged from the joint to the injection tube 1404b, soiling and impurities or other external particles that may be added to the lubricant during the passage through the joint are introduced into the lubricant It is removed by the filtration device 1427 to ensure the quality and the desired effect of the lubricant upon reuse. The filtration device 1427 has a filter 1428 disposed in the flow passage so that the entire lubrication fluid passes through the filter. Filter device 1427 can periodically clean filter 1428 by removing particles filtered through filter 1428 and accumulating it in a closed accumulation space 1433. As another example, the filtered particles may also be returned back into the patient's body, e.g., into blood vessels, and the like.

The embodiment shown in FIG. 1F can cover a wide variety of storage types, but only specific storage types are described below. The volume of the reservoir R shown in Fig. 1F is divided into two sections by the membrane 1429. Fig. One section is filled with gas and the other section is filled with lubricant. The filling inlet port 1430 allows the filling solution to be filled into the reservoir R using the supply needle through the skin 1405 of the patient. In the state in which the storage section R is stuck, the gas section is in an ambient pressure state or in a state of over-pressurization. As the lubricant flows out of the reservoir R during each lubrication cycle, the pressure in the gas section will be reduced below ambient pressure, i.e., with a negative relative value. Depending on the specific type of pump P, a manual ball valve 1431 for preventing all back flow from the pump P to the reservoir R, and all counter-currents from the reservoir R to the fluid connection conduit 1402b It may be beneficial to provide another passive ball valve 1432 for preventing overheating.

The motor M is controlled wirelessly by a control unit C which is implanted in the patient's body. However, it is also possible to mount the control unit C outside the patient's body, establish wireless communication between the control unit C and the motor M, or provide a galvanic contact through the skin of the patient. Preferably, in a case where the control unit C is programmable, preferably wirelessly or galvanically, from outside the patient's body, in order to suitably adjust the configuration of the control unit according to the change request, the control unit C controls the motor M Lt; / RTI > The control unit C determines not only the time period between the injection cycles but also the amount of lubricating liquid injected into the space in each injection cycle. In place of or instead of the control unit C, a pressure-sensitive switch for actuating the motor M can be disposed subcutaneously.

There are various ways of providing energy to the motor M. For example, energy may be provided to charge the accumulator A outside the patient ' s body, such as a rechargeable battery and / or capacitor. 1F, the in vitro primary energy source E is connected to an energy conversion device T that converts energy of a first type into a second form, such as electrical energy, Type energy. The electric energy is used to charge the capacitor (A), which provides the second energy to the motor (M) if necessary.

In general, the external energy source E may be configured to form an external field, such as an electromagnetic field, a magnetic field, or a residual field, or to generate a wavelength signal, such as an electromagnetic or sonic signal. For example, the energy conversion device T shown in FIG. 1F may function as a solar cell, but may also be suitable for a particular type of wavelength signal of the primary energy source E. Further, the energy conversion device T may be configured to convert the temperature change into electrical energy. Instead of an external primary energy source (E), an implantable primary energy source (E), such as a capacitor (A), may be replaced by a battery of a longer lifetime. The energy signal can also be used to convey the control signal of the control unit C through appropriate modularization of the energy signal, regardless of whether the energy is delivered wirelessly or wireline, It can act as a carrier wavelength signal for the analog control signal. More specifically, the control signal may be a frequency, phase, and / or amplitude modulated signal.

2A shows a detail view of an implanted lubrication apparatus that includes an injection needle 1403 having a tip end 1408. Fig. The tip end 1402 is at the distal end thereof and has a discharge port 1409 for transferring the side lubrication fluid. The needle 1403 is disposed in a longitudinal displacement within the open-ended connecting tube 1402 when operated by the driving mechanism D. [

The fluid connection pipe 1402 is attached to the implanted pump (P). The pump P is schematically shown and can be designed in a number of ways. In Fig. 2A, the reservoir R in which the lubricant to be injected into the joint space of the patient is retained is a part of the pump P. Fig. As another example, the reservoir R may be spaced apart from and connected to the pump P, as shown for example in FIG. 2B. 2A, however, the movable or flexible wall 1410 of the pump P may be realized as a piston or the like, and the wall is connected to the injection needle (not shown) through the fluid connection pipe 1402 in the reservoir R (Or manually) to pump the lubricating fluid intermittently toward the first and second ends 1401, 1402, 1403. The pump P may be, for example, a motor-driven type, and the motor may be automatically controlled to intermittently inject a predetermined amount of lubricant into the joint space through the injection needle 1403 at predetermined time intervals. The storage part R, the pump P and / or other parts of the implanted lubricating device, such as the motor, the automatic control part for the motor, and the like, preferably include the injection needle 1403 and the drive mechanism D They are transplanted together. Of course, other suitable modifications are possible, as will become apparent upon further consideration of other embodiments of the invention.

2A, as the pressure in the reservoir R is increased by the action of the movable / flexible wall 1410, the force of the spring 1411 of the drive mechanism D is restrained by the force of the injection needle 1403). That is, the tip end 1408 of the injection needle 1403 will be infiltrated into the joint space to be lubricated. If the return spring 1411 is fully compressed and the pressure exerted by the movable / flexible wall 1410 on the lubrication fluid further increases, the ball valve 1412 will return to the second return stroke 1411 more than the first return spring 1411, Spring 1413 and will be moved. In this manner, as long as the pressure is applied to a sufficiently high level, the lubrication fluid will be pumped through the fluid connection tube 1402, the hole injection needle 1403 and the needle outlet port 1409 to the patient ' s joint space. When the pressure is released, the ball valve 1412 will be closed by the return springs 1411 and 1413, and the injection needle 1403 will then return to its initial position as shown in FIG. 2A. This process will be repeated periodically depending on the condition and type of joint to lubricate to achieve intermittent lubrication of the individual joints.

It should be noted that the force acting to move the injection needle 1403 forward can be calculated as the product of the actual pressure and the cross section of the needle 1403. [ Because the cross-section of a typical injection needle is relatively small, a high pressure would have to be created to penetrate the joint space and overcome the reaction forces of the return springs 1411 and 1413. It is therefore advantageous to construct the drive mechanism D such that two severely separated chambers are made in front of and behind the drive mechanism. Therefore, when the chamber behind the drive mechanism D is maintained at a low pressure such as ambient pressure, the force acting on the injection needle 1403 will correspond to the product of the actual pressure and the overall cross-section of the drive mechanism D, It will be substantially higher.

This is shown in FIG. 2B. The drive mechanism D includes a piston 1414 attached to the injection needle 1403 as shown in Fig. The piston 1414 separates the first chamber 1415a in front of the piston 1414 and the second chamber 1415b in the rear of the piston 1414. The pressure in the first chamber 1415a is the pressure generated by the pump P, but the pressure in the second chamber 1415b can be maintained at a lower value. For example, the chamber 1415b can be filled with a compressible gas. In such a case, the return spring 1411 may be omitted since the compressed gas will form a needle retraction force.

However, the gas chamber is difficult to securely seal. Thus, the second chamber 1415b is instead filled with a fluid such as a lubricant, and the fluid can be driven into a flexible volume 1416. [ The flexible volume 1416 can be of a simple balloon type that can fill up without forming any strong resistance. As another example, the flexible volume 1416 may include a gas chamber spaced from the fluid in the second chamber 1415b by a flexible membrane. That is, in this case, the return spring 1411 can be omitted.

Instead of the flexible volume 1416, a conduit 1417 (functioning as a fluid connection tube 1402) may couple the second chamber 1415b with the reservoir R. [ That is, when the injection needle 1403 is advanced, the fluid will be discharged from the second chamber 1415b through the conduit 1417 to the reservoir R, and the injection needle 1403 is retracted by the return spring 1411 The fluid will flow back from the reservoir R through the conduit 1417 to the second chamber 1415b. The pump P and the storage section R are implanted into the patient's body together with the driving mechanism D and the needle 1403 as a single unit or spaced apart as necessary.

Figure 2C shows a very small lubrication device that is implanted subcutaneously so that the needle 1403 can be intermittently advanced into the joint during operation by the drive mechanism D, in a position very close to the lubrication joint and at a relatively appropriate location. Each component of the device is housed in an integral body 1418 that includes outer walls 1419a and 1419b. The volume determined by the outer walls 1419a and 1419b is completely filled with the lubricant. The wall portion 1419a is flexible enough to allow variation in volume that occurs upon each injection and refill. The wall portion 1419a is made of a polymeric material that is self-sealing against the penetration of the injection needle 1403. The lubrication apparatus can thus be refilled with lubricant through the polymer wall portion 1419a in the subcutaneously implanted condition.

The other wall portion 1419b is rigid to provide some degree of stability to each of the components within the body 1418. [ The window region 1420 is formed as a hard wall portion 1419b and the penetration film 1421 is press-fitted in the window region 1420 so as to be sealed. The penetration membrane 1421 is made of a self-sealing material for penetration generated by the injection needle 1403, and the injection needle is arranged to penetrate into the joint space to penetrate and lubricate the window region 1420.

The needle 1403 is connected to a piston 1414 which separates the first chamber 1415a in front of the piston 1414 and the rear second chamber 1415b of the piston 1414 as described above in Figure 2B . A ball valve 1412 with return spring 1411 and return spring 1413 is also provided. The opening 1422 provides a connection between the second chamber 1415b and the reservoir R such that when the pressure in the first chamber 1415a rises the piston 1414 is forced through the opening 1422 2 chamber 1415b to the reservoir R, at which time the reservoir R is generally at ambient pressure.

The pressure in the first chamber 1415a is increased by a pump having a movable / flexible wall 1410 that is moved back and forth by a suitable drive mechanism, motor, and the like. A flow passage 1423 is formed in the housing 1424 in which the piston 1410 is arranged in a slidable manner. The flow path has a flow constriction 1425 and a discharge opening 1426 inside the housing 1424.

The injection apparatus shown in Fig. 2C operates as follows. When the movable / flexible wall 1410 moves (i.e., moves in the direction of the arrow), the lubricant in the first chamber 1415a flows through the oil passage 1423 due to the flow compression portion 1425 in the oil passage 1423 The needle 1403 and the piston 1412 are moved in the window region (not shown) while the lubricant is discharged from the second chamber 1415b through the opening portion 1422 to the storage portion R, 1420). The pressure in the first chamber 1415a ultimately reaches the spring force of the return spring 1413 when the piston 1412 is at its distal end and the movable / flexible wall 1410 moves further in the direction of the arrow, So that the ball valve 1412 is opened and the lubricant is in turn being supplied to the main body 1418 of the lubrication apparatus through the tip end 1408 of the hole 1403 passing through the membrane 1418 Is supplied to the appropriately positioned joint. When the movable / flexible wall 1410 slides in the opposite direction and the pressure in the first chamber 1415a is released, the ball valve 1412 is immediately closed and the piston 1412 and the injection needle 1403 are simultaneously retracted It will re-enter the retracted position. The flow path 1423 is required to move the movable / flexible wall 1410 further backward even after the piston 1412 reaches the starting position so that additional lubrication fluid flows from the reservoir R to the first chamber 1415a, And the additional lubricant replenishes the amount of lubricant delivered to the patient during the intermittent injection cycle. In addition to the intermittent advancement and retraction capability of the drive mechanism D, the drive mechanism of the lubrication apparatus shown in Fig. 2C includes means for moving the tip end 1408 of the injection needle 1403 to the side in order to prevent fibrosis and the like May be further included.

The lubrication apparatus shown in FIG. 2C provides several advantages, such as not using any gas chambers and requiring no special sealing of the movable / flexible wall 1410 and the piston element 1412. It should be noted that although the injection needle 1403 and the return springs 1411 and 1413 are preferably made of inert metal, all parts of the injection apparatus shown in Figure 2B can be made of a polymer material.

2D is a cross-sectional view of a motor-pump unit that can be used in combination with the arrangement shown in FIG. 1F. Such motor-pump units are well described in WO 2004/012806 A1, and other pump units described in this document can be used in combination with the present invention. The motor pump unit includes a valve pump assembly wherein the membrane pump P and the valve pump apparatus 1434 are comprised of two major components of the assembly mounted within the cylindrical housing 1435. The valve device 1434 includes a first valve member that is fixedly mounted on the housing 1435 and is in the form of a fixed ceramic disk 1436 and a second valve member that is rotatable relative to the fixed disk 1436 in facing relationship with the ceramic disk 1436, And a second valve member in the form of a ceramic disc 1437. The motor 1438 is mounted on a housing 1435 surrounding the ceramic disks 1436 and 1437. The motor 1438 rotates the disk 1437 such that the disk 1437 follows the rotation of the motor 1435 but slightly moves the disk 1437 in the axial direction relative to the motor shaft 1439, And a splined motor shaft coupled with the corresponding spline in the hole. On the motor shaft 1439 is provided a stop member 1440 and a spring washer 1441 which exerts a slight pressure against the disk 1437 to force against the stop disk 1436.

The pump P includes a pump membrane 1451, which can be any type of membrane. Preferably, film 1451 is a metal film, for example a titanium film, or a type of coated plastic material for preventing diffusion of fluid through film 1451 and prolonging its lifetime over time. In this embodiment, the actuating device incorporated in the valve pump assembly includes a cap sleeve 1452 having a cut-out groove with two opposed cam surfaces 1453, A cam wheel 1454 that rotates within the cut-out groove and pushes the cam surface 1453, and a pump shaft 1455 that is connected to the rotating disk 1437. Cam wheel 1454 is mounted on pump shaft 1455 through cam wheel shaft 1456. Pump shaft 1455 is coupled to a disk 1437 that rotates through a splined shaft 1461 that is coupled with a corresponding spline in the upper center hole 1461 in the rotatable disk 1437, Rotate. The described spline coupling allows the disk 1437 to move in some axial direction relative to the pump shaft 1455. The pump shaft 1455 is mounted in an encapsulated ball-bearing 1458 and is axially fixed relative to the ball-bearing 1458. Several long grooves 1459 on the pump shaft 1455 extend through the ball-bearing 1458 and extend between the first chamber 1442 of the fixed disk 1436 and the pump chamber 1460 below the membrane 1451 And is provided as a fluid channel.

When the motor 1438 rotates, the film 1451 moves up and down. As the membrane 1451 moves up and down the rotatable disk 1437 connects the first channel 1442 alternately with the second and third channels 1444 and 1445 so that the fluid flows through the second channel 1444, Or from the third channel 1445 to the pump channel 1460 or from the pump chamber 1456 by the second channel 1444 or the third channel 1445. In Figure 2D the first channel 1442 is connected to the second channel 1440 via the open channel 1450 such that the second channel 1444 receives fluid from the chamber 1460 through the first channel 1442, It is shown to be connected.

The individual materials selected as disks 1436 and 1437 are very important because these disks must be able to operate with very precise tolerances without sticking to each other over time. There are several commercially available materials suitable for this purpose, such as ceramic or ceramic and mixtures of other materials such as carbon filters.

Figure 3 illustrates a medical device according to an embodiment in which the medical device may replace the contact surface of the femur's femur of a human patient. In the medical device according to this embodiment, the artificial contact surface 1103b of the medical device includes a plurality of channels that can lubricate the human patient's hip using lubricant. In addition, the medical device includes a fixating portion 44 for securing the medical device to the femoral head and / or the collum femur of the femur.

4 shows a medical device including a plurality of channels connected in a fluid-flow manner with a reservoir (non-reservoir) via a conduit 1106 disposed in the center of the fixation portion 44, 1105 of the medical device of Fig. The conduit 1106 transports the lubricant to the inlet 1123 for additional supply to the channel 1105. The end of the conduit is a connecting section 1111, which can connect the conduit to the second conduit 1106 or reservoir, or to an additional channel.

Figure 5 is a front view of a human patient's body illustrating a laparoscopic / arthroscopic hip arthroplasty procedure to provide a medical device according to any of the embodiments of the present invention in a direction opposite the acetabulum 8. The hip joint consists of acetabulum (8) and femoral head (5). Through the small incision 14 in the abdominal wall of a human patient, the laparoscopic / arthroscopic trocar can be inserted into the patient's body. Thereafter, a device 34 for introducing, attaching, connecting, attaching to, creating, or filling the implantable medical device, or a surgical device 35 that can make a hole in the pelvic bone 35, (36) can be inserted into the body through the laparoscopic / arthroscopic trocar cap (33a, b, c).

6 is a body side view of a human patient showing the hip joint shown in the fragmentary view. The hip joint consists of the femoral head (6), which is the upper part (7) of the femur, and the femoral head (5), which is the uppermost part of the femur. The femoral head 5 is connected to the acetabular portion 8, which is the bowl-shaped portion of the pelvic bone 9. The laparoscopic / arthroscopic trocar cap 33a, b, c may include one or more cameras 34, a surgical device 35 that can puncture the pelvic bone 9, or an implantable medical device, The hip 36 is reached using the device 36 for attaching, creating or filling.

FIG. 7 shows dissection of the pelvic bone 9 to create a hole 18 in the pelvic bone 9. The hole 18 is formed from the abdomen side of the pelvic bone 9 through repetitive or continuous movement of the piercing device 22 mounted on the human patient from the abdominal side of the pelvic bone 9. [ The hole 18 extends from the opposite side of the acetabulum 8 through the pelvic bone 9 to the hip joint 19. In the first embodiment, the aperture 18 is large and allows the implantable medical device to pass through the entire functional size through the aperture 18.

8A shows a second, much smaller aperture 20 made by a laparoscopic / arthroscopic or surgical method, as shown in FIG. 8A, where the aperture forming device 22 can make the aperture 20 smaller. And also shows the dissection and dissection performed on the human body.

8B shows a section of the hip joint in which a medical device is provided between the femoral head 5 and the acetabulum. The medical device according to the present embodiment includes multiple channels 1105 connected to a conduit 1106, which is connected to a connection disposed in the hole of the pelvic bone 9. The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105. May be pressed or compressed by a medical device for insertion through the hole 18 in the pelvic bone 9, which is smaller than the medical device, or in other embodiments, may be absorbed by the human body, Can be molded into a location in the mold that can be provided as a surface. The medical device may be secured using an adhesive or a mechanical fastening element.

9A shows a hip joint piece when a medical device is provided through a hole 18 in the pelvic bone 9 to replace the contact surface of the femoral head 5. [ The medical device includes a fixation portion 44 positioned at the center of the medical device and capable of fixing the medical device to the femoral head 5, and an artificial contact surface 1103b. The medical device includes a plurality of channels 1105 present in the artificial contact surface for softening the hip joint. The channel is in fluid connection with the conduit 1106 which is connected to an interconnect 1111b that connects the conduit to the second conduit 1106b or a second portion of the conduit 1106b, And fluidly intercepts the reservoir 1108 located within the femur 7 of the human patient. 9A, the pressurized lubrication fluid is introduced into the movable wall portion 1110 in the form of a piston 1110, which pressurizes the lubrication fluid, Which is a spring provided by a spring 1109 combined with the spring 1109. [ The reservoir 1108 is also connected to the injection port 1107 which is located in the lower part of the trochanter 1186 in combination with the femur 7 but can be combined with any other suitable arrangement, Placement is also possible. The medical device is operable using a pressurized reservoir in accordance with the embodiment of FIG. 9a, and in another embodiment, a direct propulsion, such as induction or self-propelling, , A powered operating device such as an implantable pump, or the like. A channel or conduit (not shown) according to one embodiment includes a valve that closes the flow of lubricant through conduit 1106 or channel 1105, closing the connection between the reservoir and the artificial contact surface. The valve may be configured to operate and control outside the body using, for example, remote control.

9B shows a hip joint section in which a medical device according to another embodiment is provided in the hip joint and replaces the contact surface of the femoral head. The medical device includes an artificial contact surface 1103b that includes a plurality of channels 1105 coupled with conduits 1106 and 1106b located at the fixed portion of the medical device. The conduit is then in fluid communication with a reservoir 1108 located within the femur, preferably within the porous portion of the femur, such that the reservoir is in fluid communication with the channels of the medical device to lubricate the artificial contact surface 1103b of the medical device, Exchange.

Figure 10 shows a hip joint provided with an implantable medical device capable of replacing the acetabular interface. The medical device includes an artificial acetabular surface 65 that includes a plurality of channels that are connected to the conduit 1106 by interconnect 1111. The medical device can be placed in the hole 18 of the pelvic bone 9 to replace the acetabular contact surface 65 in the embodiment shown in Fig. 10 also shows a unit connected to a conduit, which in one embodiment comprises a reservoir 1108, a conduit 1106 and, in addition, a plurality of channels 1105 for lubrication of the implantable medical device And two pressure forming devices 1113a and 1113b capable of forming a pressure for pressurizing the lubricant for pushing the lubricant through the two pressure forming devices 1113a and 1113b. The conduit 1106 also transports the lubricant to the inlet 1123 for distribution to the channel 1105. The pressure forming device can be composed of an installed spring or a pressurized gas filled element that is further pressurized by injecting lubricant into the reservoir 1108. The unit further comprises an injection port 1107 comprising a self-sealing membrane 1112, preferably a parylene-coated silicon membrane. In another embodiment, the unit includes a powered actuator, such as a pump housed in a receptacle 1113a, for pumping lubricant from the reservoir 1108 to the plurality of channels 1105 via conduit 1106 . In one embodiment, the pump is powered through a battery housed within compartment 1113b.

11A illustrates a surgical instrument capable of inserting a medical device according to any of the embodiments provided herein, or a mold for making a medical device according to the first embodiment. The surgical instrument includes a gripping portion 76 and a handling portion 77. In the embodiment shown in Figures 11a, b and c the instrument further comprises a rotating element 78 which is capable of rotating the gripping portion 76 according to the handling portion 77, ) Are considered equally.

Fig. 11B shows a surgical instrument capable of inserting a prosthesis, artificial organ part or parts necessary for forming or providing a hip surface according to the second embodiment. Fig. In this embodiment, the surgical instrument further comprises a parallelly disposed section 79 that enhances and facilitates the access of the device from the acetabulum to the hip joint through the hole of the pelvic bone.

Fig. 11C shows a surgical instrument capable of inserting artificial organs or parts or parts necessary to form or provide a hip surface as a third embodiment. Fig. In this embodiment, the surgical instrument further comprises two angle adjusting members 80a, b. The angle regulating member may control the angle change of the gripping portion 76 along the handling portion 77 or may be arranged at an appropriate angle that allows operation from the hip joint through the hole of the pelvic bone from the opposite side of the acetabulum 8 Can be fixed.

Figure 12 shows a hip joint section provided with a medical device. Although the implantable medical device is adapted to replace the acetabular surface and to be inserted into the hole 18 of the pelvic bone 9, in other embodiments, the medical device may be configured to be inserted into the hole of the femur 7 or the hip joint capsule The same can be considered. The medical device includes a plurality of channels 1105 interconnected through a conduit 1106, and the channels 1105 are disposed in such a manner as to mutually fluidize. The conduit 1106 transports the lubricant to the inlet 1123 for further distribution to the channel 1105. The conduit 1106 is also connected to a first portion of the interconnect 1111, which is configured to couple to a second portion of the interconnect 1111b. The interconnecting portion 1111 connects the first portion of the conduit 1106 with the second portion of the conduit 1106 so that the first portion of the conduit 1106 is inserted from the non-bulb side of the pelvic bone 9, Can be inserted from the nipple opposite to the pelvic bone side or the pelvic bone 9. Connecting the two portions of the conduit 1106 may be accomplished by inserting the medical device into the femur 7 or the hole 18 in the hip joint and implanting the reservoir 1108 into the abdomen of a human patient, If transplanted to other parts of the abdomen side, it is particularly beneficial. Next, the conduit 1106 is connected to the reservoir 1108 to transport the lubricant from the reservoir 1108 to the hip joint region. The storage 1108 includes a spring 1108 that exerts a force on the movable wall portion in the form of a piston 1110 that applies pressure to the lubricant through the conduit 1106 and through the channel 1105, (1109), the pressure can be applied to the lubricant. The reservoir 1108 further includes an injection port 1107 disposed at the top of the reservoir 1108 to fill the reservoir 1108 and simultaneously increase the pressure of the lube fluid.

13A is a side view of a human patient showing a hip joint section. The femur (7) has a recent upper part consisting of a proximal femoral neck (6) and a femoral head (5). In Fig. 13A, the hole 82 is made from the incision on the femur, and the hole extends to the femur 7, the femoral neck 6, through the femoral head 5 and into the hip joint. The hole is used to provide a medical device that can be bent or bent for insertion into the hole 82 preferably in the hip joint.

Fig. 13 (b) shows a hip joint section in which the medical device is provided in the bore 82 of the femur 7 and is fixed to the acetabulum 8. Fig. The medical device includes a plurality of channels 1105 that connect to each other by a conduit 1106. In another embodiment, the medical device may be provided in the bore of the hip capsule or pelvic bone 9. [ A tool 1180 for housing a storage portion 1108 connected to the conduit 1106 is used to provide the storage portion 1108 in the hole 82 of the femur 7, Lt; RTI ID = 0.0 > 1106 < / RTI >

13C shows a hip joint section when the reservoir 1108 disposed in the bore 82 of the femur 7 is connected to the medical device. The conduit 1106 also extends from the reservoir 1108 to the injection port 1107 to refill or pressurize the reservoir 1108.

13D is a detailed view of the storage unit. The storage unit includes an interconnecting portion 111 disposed at the distal end of the storage unit, a movable wall portion 1110 in the form of a piston 1110, And a pressurized reservoir 1108 that is pressurized by using a spring 1109 that pushes the fluid. The storage unit further includes a conduit 1106 connected to the reservoir and the injection port 1107 to fill and / or pressurize the reservoir 1108 containing the lubricant. The injection port 1107 includes a self-sealing film that can be a self-sealing parylene coating silicon film to inhibit cell migration on the surface of the injection port. Section A - A shows the conduit 1106 disposed in the center of the reservoir 1108 for filling and / or pressurizing the reservoir 1108.

14 is a cross-sectional side view of a human patient showing injection into an injection port 1107 for injecting a lubrication fluid by an injection member 92 including a container 1115 capable of containing a lubricant to be injected. The infusion port is connected to the implantable medical device disposed in the hip joint via a conduit 1106 that can provide fluid flow between the infusion port and the medical device. Next, the medical device includes a plurality of channels 1105 for lubrication of the artificial contact surface, thereby lubricating the hip joint. In the embodiment shown in Fig. 14, the medical device is provided from the abdomen side of the pelvic bone 9 through a hole made in the pelvic bone, then reinsert the removed bone plug, seal with a screwed mechanical anchorage, do. In another embodiment, the medical device is provided through the hip capsule 12 or the femur 7 from the hip joint side of the pelvic bone 9 and then through the interconnect 1111 to the abdomen of the pelvic bone 9, Lt; RTI ID = 0.0 > 1106 < / RTI > In this way, the injection port 1107 can be placed in the abdomen, subcutaneous, intramuscular, and / or supported by muscle or fascia tissue.

15 shows a medical device as another embodiment, wherein the medical device includes a first artificial contact surface 112 that includes a convex shape in the center of the hip joint. The first artificial contact surface 112 may be secured to the pelvic bone 9 of a human patient. An artificial convex hip joint surface 112 may be secured to the pelvic bone 9 and may be inserted through the hole 18 in the pelvic bone 9. The medical device includes a nut (120) including a thread for securely securing the medical device to the pelvic bone (9). The medical device also includes an artificial portion 118 designed to occupy the hole 18 made in the pelvic bone 9 after the medical device has been implanted in the patient. The prosthetic portion 118 includes a support member 119 designed to contact the pelvic bone 9 and assist in dispersing the load exerted on the medical device during normal use from the weight of the human patient. Normal use is defined as the same as a person using a natural hip joint. In addition, the medical device includes a locking device 116 that includes a surface 117 designed to contact the articulating hip convex surface 112. The locking device 1160 further includes a locking member 115 that is configured to secure the locking device 116 to the femoral head 5 or the femoral neck 6 and assist in securing the articulating hip convex surface 112 again do. The articulating hip convex surface 112 is secured to an attachment rod 113 that includes a thread 114 that corresponds to the thread of the nut 120 associated with the prosthetic portion 118. The medical device includes a plurality of channels 1105 designed to lubricate the artificial contact surface 112. The plurality of channels 1105 are designed to transport lubricant from the reservoir into the plurality of channels 1105 fully integrated into the artificial contact surface 112 of the medical device to lubricate the artificial contact surface 112 to lubricate the hip joint. And are connected to each other through a conduit 1106.

Fig. 16 is a medical device according to Fig. 15 showing when the medical device is placed inside the hip joint. Fig. The first artificial contact surface 112 including the convex shape toward the center of the hip joint is disposed inside the second artificial contact surface 109 including the concave shape toward the center of the hip joint. The second artificial contact surface 109 is tied by a locking device 116 including a surface 117 facing the first convex articulating surface 112 to allow the femoral head 5 and the femoral neck 6 As shown in Fig. The medical device includes a plurality of channels 1105 coupled with a conduit 1106 disposed in the center of the medical device to lubricate the artificial contact surface 112 and thereby lubricate the hip joint by providing a lubricant to the medical device.

Figure 17 shows the attachment of the prosthetic portion 118 to the hole 18 of the pelvic bone 9. The prosthetic portion 118 includes a support member 119 designed to contact the pelvic bone 9 and assists in balancing the load exerted on the medical device during normal use from the weight of the human patient.

18 shows another embodiment in which a portion of the medical device comprising a convex artificial hip surface disposed on the femoral head 5 and the femoral neck 6 is positioned in the porous tissue of the medical device and the femoral neck 6. [ And a plurality of lubrication channels (1105) connected to a conduit (1106b) establishing fluid flow between the reservoirs. The reservoir can be filled through the injection port, which is disposed in conjunction with the femur 7 and disposed substantially below the electron 1186, in the embodiment of FIG. The storage unit and its function are described in more detail with reference to Figures 9a and 9b. 18 shows the artificial engine part 118 when it is fixed to the pelvic bone 9 by using the screw 121. FIG. The screw can be assisted or replaced by a glue on the surface (S) between the prosthetic and pelvic bones (9) or by an adhesive which can be applied in conjunction with a screw.

Figure 19 shows the right leg of a human patient. A femur (102) having a distal portion comprising an outer joint bump (105), an inner joint bump (106) and a region between the outer and the inner joint bumps. The distal section of the femur 102 includes the contact surface of the knee. In addition, the knee joint includes a triangular pinion 101, which protects the femur 102 from the knee joint by connecting the joint with the femur 102. The knee joint also includes the meniscus 107, 108, which is a cartilage component inside the knee joint, which is provided as an articulating surface to protect the ends of the bone from rubbing against each other. Meniscus cartilage 107, 108 also acts as a shock absorber in the knee joint, absorbing the impact of movement of a human patient. Each knee has two meniscal cartridges 107, 108, an inner meniscus 107, and an outer meniscus 108. In osteoarthritis patients, the meniscus 107, 108 acting as an articulating surface, i.e. acting as a weight carrying surface, is worn out, and in severe cases the bones may be exposed to the joints. The knee joint is also protected by a knee joint capsule, also referred to as the articular capsule of the knee, or a capsular ligament of the knee. The knee capsules are wide and loose, with anterior and lateral sides thin, and bursae, a small cyst that contains small body fluids composed of patella (101), ligament, meniscus (107,108), and white fibrous tissue . Knee capsule is composed of synovial membrane and fibrous membrane, separated by anterior and posterior lipid accumulation.

Figure 20 shows the knee joint in which the artificial knee surfaces 130 and 116a are provided at the distal portion of the femur 102 and at the proximal portion of the tibia 104. [ The outer and inner channels 125a, b provide a contact surface, thus supplying lubricant to the knee to reduce friction of the knee.

Fig. 21 shows a front view of the human patient's body where the storage unit 127 is subcutaneously implanted in the abdomen of a human patient. The storage unit according to the present embodiment includes a pump 130 that is powered by a battery for pumping fluid from the reservoir 129 to the channel 125 through a conduit to supply lubricant to the artificial contact surface of the knee, Lt; / RTI > The storage unit is configured to penetrate through the muscle or fascia tissue 1181 clamping between the storage unit and the injection port 1107 disposed outside of the muscle or fascia tissue 1181 to allow the muscle or fascia tissue 1181, respectively.

22A shows an embodiment of the case where the medical device includes an artificial knee joint 115 surface that clamps the medial, lateral or medial and lateral articular ridges 106 of the knee, distal of the femur 7 Show. The medical device according to the present embodiment includes a plurality of channels 1105 for lubricating the artificial contact surface, the plurality of rings fluidly interchanging with each other through the conduit 1106, and also the lubricant contained in the reservoir 1108 Including an inlet port 1107 for applying pressure or refilling the reservoir. The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105.

22B shows a side view of the knee joint in which the medical device including the artificial contact surface 1102 is provided in the proximal portion of the tibia 104 constituting the lower portion of the leg together with the fibula 103. Fig. The artificial knee joint surface includes a plurality of channels 1105 in fluid communication with a conduit 1106 capable of transporting lubricant from the reservoir 1108. The storage unit 1108 is disposed on the rear side of the tibia 104 according to the embodiment of FIG. 22B and is fixed to the tibia 104. The storage unit 1108 injects the lubricant into the storage unit 1108 and / or enters the storage unit 1108 And an injection port 1107 for applying pressure to the lubrication fluid. The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105.

23 is a detailed view of a medical device for a knee joint implantation. The medical device includes a plurality of channels (1105) disposed along the artificial contact surface of the medical device to lubricate the contact surface of the medical device. The channel 1105 is connected to a conduit 1106 for transporting lubricant along the artificial contact surface 1101 of the medical device. The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105.

Figure 24 is a side cross-sectional view of a medical device, showing that channel 1105 is fully integrated and interconnected with the artificial contact surface, wherein conduit 1106 lubricates channel 1105 to lubricate the artificial contact surface of the medical device. Supply. The conduit 1106 transports the lubricant to the inlet 1123 for additional distribution to the channel 1105.

25 shows a medical device for a knee joint implant in a human patient comprising a mechanical fastening element 120 providing a fitting between a plurality of medical device parts 119 and a base part 118, Some medical device parts 119 that can be connected to the medical device base part 118 and can also be connected to one another. The medical device base part 118 also includes a fixation portion 117 that is capable of mechanically securing the medical device to the human bone, such as the proximal portion of the tibia. In addition, the medical device base part 118 includes a channel for providing lubricant to the artificial contact surface of the knee.

Fig. 25B shows a case where the medical device of Fig. 25A is assembled.

Fig. 26 shows a case where the medical device according to Figs. 25A and 25B is fixed to the tibia 104. Fig.

FIG. 27 shows the proximal portion of the tibia, where a medical device including an artificial contact surface 1160 is secured to the tibia 104. FIG. The channel 1105 of the artificial contact surface is configured to provide fluid flow between the channel 1105 of the medical device and the first and second reservoirs 1108 disposed inside and outside of the tibia 1104, The conduit 1106 and also the conduit connects the first and second reservoirs to the injection port 1107 disposed inside the pelvic bone for recharging and / or pressurizing the reservoir 1108. In the embodiment shown in Fig. 27, the reservoir 1108 is designed to pressurize the lubricant, thereby pushing the lubricant out of the channel 1105 onto the artificial contact surface, for lubrication of the knee joint. To this end, the reservoir 1108 is associated with a movable wall portion in the form of a piston 1110 for pushing out the lubricant.

28 shows a front view of a human patient implanted with the implantable lubrication system 120. Fig. The implantable lubrication system 120 may inject the lubricant continuously, intermittently or as needed to the hip joint. In the embodiment shown in Figure 61, the implantable lubrication system includes two interconnected units 121,122. These two interconnected units are located in the abdominal region of the human patient and are connected to the hip joint via conduit 1106.

29 shows a detail view of an implantable lubrication system 120 that can be used in combination with any of the medical devices described herein. In this embodiment, the implantable lubrication system includes a first unit 121 that includes a pumping member 123 that is capable of pumping lube fluid from the reservoir 1108 to the hip joint region. The first unit 121 also includes an injection port 1107 for filling the reservoir 1108 from outside the human body without performing surgical procedures. The injection port 1107 includes a self-sealing membrane that can penetrate the needle attached to the syringe. The first unit 121 further includes a wireless energy receiver 124, preferably including a coil. The wireless energy receiver is used to charge the battery 126. In this embodiment, the implantable lubrication system 120 additionally includes a second unit 122, followed by a battery 126 and a fluid reservoir 1108. The lubrication fluid 128 is delivered to the artificial contact surface of the implantable medical device through the first unit 121 using the pumping device, via the conduit 1106, into the region of the hip joint, Helps lubrication of the hip surface. The lubricant is preferably a biocompatible lubricant such as hyaluronic acid.

Figure 30 illustrates the use of any of the medical devices described herein, in accordance with an embodiment, in which the implantable lubrication system is a cyclic lubrication system that includes one inlet 130 and one outlet 131 to the joint to lubricate. Which shows a portable, lubrication system. Preferably, the system is a continuous lubrication system in which the pumping member 123 continuously circulates the lubrication fluid 128 within the hip joint.

31 shows an implantable lubrication system for circulating lubrication, which can utilize any of the medical devices described herein, which further includes a filter element 132 for filtering the lubrication fluid. The filter can self-clean and out filtered matter is assigned through a disposal channel 133 into a vessel attached to abdominal or ablation channel 133 of a human patient. Through filtration of the lubricant 128, the circulating lubrication system can operate for a long period of time without any surgical procedure.

Fig. 32 shows that the lubrication fluid of Fig. 29 lubricates the implantable medical device, including the artificial contact surface 45, by providing lubricant 128. Fig.

Figure 33A illustrates an alternative embodiment of the presently described embodiments of the present invention in which the lubrication system includes a unit 1310 that includes a retractable needle 1311 fixed to an operating system for operating the retractable needle 1311. [ Lt; RTI ID = 0.0 > medical devices. ≪ / RTI > The needle can pass through the self-sealing membrane 1314 disposed in the pelvic bone 9 to inject lubricant into the joint. The conduit 1106 may be supplied to the unit 1310 from an injection port and / or additional reservoir capable of submerging the lubricant liquid or implanting it into the body of the body.

Figure 33B shows a lubrication system in which a retractable needle 1311 is placed in a position advanced by an actuating device with an operatively operated retractable needle 1311. [ The needle passes through the self-sealing film 1314 and is disposed at a position where injection of the lubricant is possible.

Figure 34 illustrates an example of a system for treating a disease comprising an apparatus 10 of the present invention (hereinafter referred to as a graft device 10) disposed in the abdomen of a patient. The implanted energy conversion device 1002 can supply energy to the energy consuming component of the device via the power supply line 1003. An external energy delivery device 1004 for non-invasively supplying energy to the implant 10 delivers energy by means of one or more radio energy signals. The implanted energy conversion device 1002 converts the energy from the radio energy signal to electric energy supplied through the power supply line 1003.

The implanted energy conversion device 1002 may also include other components, such as a signal and energy receiving and / or transferring coil, a signal receiving and / or transferring antenna, a micro-controller, a charge control unit And optionally controls the operation of motors, pumps, and medical implants, including one or more sensors, such as capacitors, energy storage, temperature sensors, finger sensors, position sensors, motion sensors, etc., transceivers, Other parts may be included.

The wireless energy signal may include a wavelength signal selected from the following: a sonic signal, an ultrasonic signal, an electromagnetic wave signal, an infrared signal, a visible light signal, an ultraviolet signal, a laser beam signal, a microwave signal, Signal and gamma radiation signal. In another example, the wireless energy signal may comprise an electric field, a magnetic field, or a combination of an electric field and a magnetic field.

The wireless energy delivery apparatus 1004 may deliver a carrier signal for sending a wireless energy signal. These carrier signals may include digital, analog, or a combination of digital and analog signals. In this case, the wireless energy signal includes an analog signal, a digital signal, or a combination of analog and digital signals.

Generally speaking, the energy conversion device 1002 is provided for converting a first type of radio energy transmitted by the energy delivery device 1004 into a second type of energy, typically different from the first type of energy . The implanted device 10 is operable in response to a second type of energy. Since the energy conversion device 1002 converts the energy of the first type transferred by the energy transfer device 1004 into energy of the second type, the energy conversion device 1002 directly supplies a second type of energy to the device can do. The system may additionally include an implantable capacitor, wherein the second type of energy is at least partially used to charge the capacitor.

As another example, the wireless energy delivered by the energy delivery device 1004 can be used to provide power directly to the device, since the wireless energy is transmitted by the energy delivery device 1004. When the system includes an operating device for operating the device as described below, by using the wireless energy transmitted by the energy conversion device 1004, by directly powering the operating device, the kinetic energy Can be generated.

The first type of radio energy may include a sound wave, and the energy conversion device 1002 may include a piezo-electric element that converts the sound waves into electric energy. The second type of energy may include electrical energy in the form of a pulsed direct current or a combination of direct current and pulsed direct current, alternating current, or a combination of direct current and alternating current. Typically, the apparatus includes electrical components that are powered by electrical energy. Other implantable electrical components of the system may be one or more voltage level guards or one or more constant current guards connected to the electrical components of the apparatus.

One of the first and second types of energy can be magnetic energy, kinetic energy, acoustic energy, chemical energy, radioactive energy, electromagnetic energy, light energy, nuclear energy or thermal energy, and the first and second types of energy The other of which is preferably non-magnetic, non-motile, non-chemical, non-acoustic, non-nuclear or non-thermal.

The energy delivery device can be controlled outside the patient's body to emit electromagnetic radio energy and the implanted electromagnetic radio energy can be used to operate the implant. Alternatively, the energy delivery device may be controlled outside the patient ' s body to emit non-magnetic radio energy and operate the device using the emitted non-magnetic radio energy.

The energy delivery device 1004 outside the patient's body further includes a wireless remote control having an external signal transmitter for transmitting a wireless control signal for controlling without inserting the device of the present invention. The control signal is received by an implanted signal receiver that may be included in or separate from the implanted energy conversion device 1002.

The radio control signal may be a frequency, amplitude or phase modulated signal, or a combination thereof. Alternatively, the radio control signal may be an analog signal, a digital signal, or a combination thereof. The radio control signal may comprise an electric field, a magnetic field, or a combination of an electric field and a magnetic field.

The wireless remote control unit may transmit a carrier signal for carrying a radio control signal. Such a carrier signal may comprise a digital signal, an analog signal, or a combination thereof. When the control signal comprises an analog signal, a digital signal, or a combination thereof, the wireless remote control may transmit an electromagnetic carrier signal for carrying a digital control signal or an analog control signal.

Fig. 35 shows the system of Fig. 34, which includes the implanting apparatus 10 of the present invention, an energy conversion apparatus 1002 for supplying power to the implantation apparatus 10 of the present invention through the power supply line 1003, The delivery device 1004 is shown in the form of a more generalized block diagram. The patient's skin 1005 is represented by a vertical line in the figure, with the right side being the patient's body and the left side being outside the patient's body with respect to the vertical line.

36 is an embodiment similar to that of Fig. 35, in the embodiment of Fig. 36, for inverting the implanted device 10 of the present invention, a reversal device (not shown) in the form of an electric switch 1006, reversing device is implanted in the patient's body. When the electric switch is operated by the polarization energy, the radio remote control of the external energy transfer device 1004 transfers the polarization energy to the radio signal, and the implanted energy conversion device 1002 converts the radio polarization energy into the polarization current To operate the electric switch 1006. [ If the polarity of the current is changed by the implanted energy conversion device 1002, the electrical switch 1006 reverses the function performed by the implant device 10 of the present invention.

37 is an embodiment similar to that of Fig. 35. In the embodiment of Fig. 37, an actuating device 1007 for operating the implanting device 10 of the present invention implanted in the patient's body is connected to the energy conversion device 1002 (10) of the present invention. This operating device may be a motor 1007 such as an electric servomotor. The motor 1007 receives energy from the energy conversion device 1002 as the remote control of the energy transmission device 1004 transmits a radio signal to the reception part of the energy conversion device 1002.

38 is an embodiment similar to that of Fig. 35 in which, in the embodiment of Fig. 38, an actuating device in the form of an assembly 1008 comprising a motor / pump unit 1009 and a fluid reservoir 1010 is implanted in a patient There is a difference. In this case, the implant device 10 of the present invention operates hydraulically. That is, the hydraulic fluid is pumped from the fluid reservoir 1010 through the conduit 1011 to the implantation device 10 of the present invention by the motor / pump unit 1009 to operate the device of the present invention. The hydraulic fluid is pumped from the implant device 10 of the present invention to the fluid reservoir 1010 by the motor / pump unit 1009 to restore the device of the present invention to the start position. The energy conversion apparatus 1002 converts radio energy into a current such as a polarized current and supplies power to the motor / pump unit 1009 through the power line 1012. [

It is contemplated that the actuation device may be a pneumatically actuated device, instead of the hydraulically actuated implanted device 10. In this case, the hydraulic fluid can be compressed air used for conditioning, replacing the fluid reservoir with an air chamber.

In these embodiments, the energy conversion apparatus 1002 may comprise a rechargeable capacitor, such as a capacitor or a battery, that is charged by radio energy and supplies energy to any energy-consuming component of the system.

Alternatively, the wireless remote control described above may be replaced by a manual control of any implanted portion, such as a push button located below the skin of the patient, for example, which is largely indirectly accessible to the patient by hand.

Fig. 39 shows an embodiment of the present invention that includes an external energy delivery device 1004 having a wireless remote control, in this example a hydraulically operated implantation device 10, and an implanted energy conversion device 1002. Fig. Embodiments of the present invention further include a transfusion device in the form of a hydraulic fluid reservoir 1013, a motor / pump unit 1009 and a hydraulic valve switching device 1014, all of which are implanted . Since the hydraulic operation can be easily performed only by switching the pumping direction, it is not necessary to provide the hydraulic valve. The remote control unit may be a device separated from an external energy transfer device or an apparatus included in an energy transfer device. The motor of the motor / pump unit 1009 is an electric motor. The implanted energy conversion apparatus 1002 supplies the energy transferred by the control signal to the motor / pump unit 1009 in response to a control signal provided from a wireless remote control unit of the external energy transfer apparatus 1004, The motor / pump unit 1009 distributes the hydraulic fluid to the hydraulic fluid reservoir 1013 and the implant device 10. The remote control of the external energy transfer device 1004 controls the hydraulic valve switching device 1014 so that fluid is pumped from the hydraulic fluid reservoir 1013 to the implant device 10 by the motor / Direction and a direction in which the fluid is pumped by the motor / pump unit 1009 from the implant device 10 to the hydraulic fluid reservoir 1013 to return the implant device 10 to the start position. To switch.

Fig. 40 shows an embodiment of an implanted internal control (e. G., An external energy transfer device) 1004 controlled by a wireless remote control of an external energy delivery device 1004 having a wireless remote control, an implantation device 10, an implanted energy conversion device 1002, Unit 1015, an implanted capacitor 1016, and an implanted capacitor 1017. FIG. The internal control unit 1015 stores the electric energy received from the implanted energy conversion apparatus 1002 in the capacitor 1016 and supplies this energy to the implantation apparatus 10. [ The internal control unit 1015 causes electric energy to be discharged from the capacitor 1016 and supplies the emitted energy to the power lines 1018 and 1016 in response to a control signal provided from a wireless remote control unit of the external energy transfer apparatus 1004. [ 1019 or by directly transmitting the electric energy from the implanted energy conversion device 1002 through the power line 1020, the capacitor 1017, the power line 1021 and the power line 1019, 10). The capacitor 1017 stabilizes the current.

Preferably, the internal control unit is programmable outside the patient ' s body. In one example, the internal control unit can be programmed to control the implantation device 10 according to a pre-programmed time schedule or according to an input from any sensor that senses a patient's physical parameters or any functional parameter of the system.

For example, the capacitor 1017 of the embodiment shown in Fig. 40 may be omitted. As another example, a configuration in which the capacitor 1016 of the present embodiment is not provided is also possible.

41 is an embodiment similar to that of Fig. 35, in which the embodiment of Fig. 41 includes a battery 1022 supplying energy for operating the implanting device 10 and an electric switch 1023 for switching the operation of the implanting device 10 It differs in that it is implanted in the patient's body. The electric switch 1023 may be controlled by a remote control, and the energy supplied by the implanted energy conversion device 1002 may be used to control the off mode in which the battery 1022 is not used and the operation of the device May be configured to switch between an on mode in which the battery 1022 supplies energy.

42 differs from the embodiment shown in Fig. 41 in that the embodiment of Fig. 42 differs in that an internal control unit 1015 controllable by a wireless remote control of an external energy transfer device 1004 is implanted in the body of the patient . In this example, the electric switch 1023 controls the wireless remote control to disable the internal control unit 1015 and to set the off mode in which the battery is not used and the wireless remote control to control the internal control unit 1015, Is activated by the energy supplied by the implanted energy conversion device (1002) so as to enable switching between standby modes that cause energy for operating the battery (10) to be released from the battery (1022).

43 is an embodiment similar to that of Fig. 42, in which the embodiment of Fig. 43 is different in that battery 1022 is replaced by capacitor 1016 and the implanted elements are connected differently. In this example, the capacitor 1016 stores the energy supplied from the implanted energy conversion device 1002. [ The internal control unit 1015 is responsive to the control signal provided from the wireless remote control of the external energy transfer device 1004 so that the off mode in which the capacitor 1016 is not used and the capacitor 1016 are connected to the implantation device 10, Lt; RTI ID = 0.0 > 1023 < / RTI > The capacitor may be combined with a capacitor or replaced by a capacitor.

Fig. 44 is an embodiment similar to Fig. 43, in which the embodiment of Fig. 44 differs in that the battery 1022 is implanted in the patient's body and the implanted portions are connected differently. The internal control unit 1015 responds to the control signal provided from the wireless remote control of the external energy transfer apparatus 1004 so that the off mode in which the battery 1022 is not used and the off mode in which the battery 1022 is connected to the implantation apparatus 10 And controls the capacitor 1016 to transfer energy for operating the electric switch 1023 so as to switch between on modes for supplying electric energy for operation.

Alternatively, the electrical switch 1023 may be operated in an off mode that is activated by the energy supplied by the capacitor 1016 to prevent the wireless remote control from controlling the battery 1022 to supply electrical energy, And a standby mode for controlling the battery 1022 to supply electric energy for operation of the apparatus 10. [

It will be appreciated that switch 1023 and all other switches in this embodiment should not be construed as limited to these. That is, power can be turned on / off using a transistor, an MCU, an MCPU, an ASIC, an FPGA, a DA converter, or any other electronic device or circuit. It is preferred that the switch be controllable outside the patient's body or be controllable by an implanted internal control unit.

45 is similar to FIG. 41, but shows a structure in which a motor 1007, a mechanical reversing device in the form of a gear box 1024, and an internal control unit 1015 for controlling the gear box 1024 are implanted in the body of the patient The embodiments are shown in different points. The internal control unit 1015 controls the gear box 1024 to invert the function (mechanically activated) performed by the implantation device 10. The gearbox of the present example may represent a servo device that saves power so that the actuator operates in the long stroke.

Figure 46 shows an embodiment similar to Figure 52, but with the implanted elements connected differently. Therefore, in this example, the internal control unit 1015 is powered by the battery 1022 when it is necessary to switch the capacitor 1016, preferably the capacitor, to the mode in which the electric switch 1023 is turned on. When the electric switch 1023 is in the ON mode, the internal control unit 1015 controls the battery 1022 to supply or not supply energy for operating the implantation apparatus 10. [

Figure 47 schematically shows a combination of implanted elements of an apparatus for achieving various communication functions. Basically includes an implanted device 10, an internal control unit 1015, a motor / pump unit 1009, and an external energy delivery device 1004 having an external wireless remote control. As described above, the wireless remote control transmits control signals received by the internal control unit 1015 to control various elements of the device to be transplanted.

To sense the patient's physical parameters, a feedback device, including a sensor or measurement device 1025, may be implanted in the patient's body. Physical parameters may be selected from the group including pressure, volume, diameter, extension, extension, extension, migration, flexion, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heart rate, The sensor can sense any of these physical parameters. For example, the sensor may be a pressure sensor or a motion sensor. Alternatively, the sensor 1025 may be configured to sense a functional parameter. The functional parameter may be related to energy transfer for modifying the implanted energy source and may include electrical, any electrical parameters, pressure, volume, diameter, extension, elongation, expansion, migration, bending, Group. ≪ / RTI >

Feedback can be sent to the internal control unit or to the external control unit via the internal control unit. Feedback may be sent out of the body via a separate communication system with an energy delivery system or a transceiver.

An internal control unit 1015 or a wireless remote control of an external energy delivery device 1004 may control the implantation device 10 in response to a signal from the sensor 1025. The transceiver may be combined with the sensor 1025 to send information about the sensed physical parameters to an external wireless remote control. The wireless remote control unit may include a signal transmission unit or a signal transmission / reception unit, and the internal control unit 1015 may include a signal reception unit or a signal transmission / reception unit. Alternatively, the wireless remote control unit may include a signal receiving unit or a signal transmitting and receiving unit, and the internal control unit 1015 may include a signal transmitting unit or a signal transmitting and receiving unit. The transceiver, transmitter and receiver can be used to transmit information or data related to the implant 10 out of the body of the patient.

Information relating to charging of the battery 1022 may be fed back when the battery 1022 supplying power to the motor / pump unit 1009 and the motor / pump unit 1009 is implanted. More precisely, when the battery or the capacitor is charged according to the energy feedback information associated with the charging process, the energy supply is changed accordingly.

48 shows an embodiment in which the implantation device 10 is controlled outside the patient's body. The system 1000 in this embodiment includes a battery 1022 connected to the implanted device 10 via a subcutaneous electrical switch 1026. Thus, control of the implant device 10 is achieved noninvasively by manually pressing the subcutaneous switch. The operation of the implant device 10 is on and off. The depicted embodiment is simplified, and it is possible to add to the system additional elements such as an internal control unit or any other components described herein. Two subcutaneous switches may be used. In a preferred embodiment, one implanted switch may transmit information to the internal control unit to perform a predetermined predetermined operation, and the patient may switch the operation once again by pressing the switch once more.

Figure 49 is an alternate embodiment, in which the system 1000 of the present embodiment includes a hydraulic fluid reservoir 1013 hydraulically connected to the apparatus. Non-invasive control is achieved by manually pressing the hydraulic fluid reservoir connected to the device. Alternatively, the hydraulic fluid reservoir 1013 is configured to operate in conjunction with an injection port for the injection of hydraulic fluid, preferably for calibration of the hydraulic fluid.

The system may include an external data communicator and an internal portable data communicator. The portable internal data communicator is capable of communicating with the external data communicator. The internal data communicator may provide data related to the device and the patient to the external data communicator and / or the external data communicator may provide data to the internal data communicator.

Figure 50 is a graphical representation of one or more of the functional parameters of a device or system to provide an accurate amount of energy to the implanted internal energy receiver 1002 connected to the implanted energy usage element of the implant device 10, And schematically shows a configuration of a system capable of transmitting information from inside the patient's body to the outside of the patient's body so as to feed back relevant information. The energy receiving unit 1002 may include an energy source and / or an energy conversion device. In short, wireless energy is delivered from an external energy source 1004a located outside the patient ' s body and received by an internal energy receiver 1002 located within the patient ' s body. The internal energy receiver is adapted to supply the received energy directly or indirectly via the switch 1026 to the energy consuming element of the implant device 10. [ The internal energy receiving unit 1002 balances energy between the received energy and the energy used for the implantation apparatus 10, and based on the energy balance thus determined, the transfer of radio energy is controlled. The energy balance provides an accurate indication of the correct amount of energy that is sufficient to properly operate the implant 10 but does not cause excessive temperature rise.

In Figure 50, the skin of the patient is indicated by the vertical line 1005. In Figure 50, the energy receiver comprises an energy conversion device 1002 located in the body of the patient, preferably directly below the skin 1005 of the patient. Generally speaking, the implanted energy conversion device 1002 can be placed under the abdomen, thorax, fascia (e.g., abdominal wall) of the patient, or any other suitable location. The implanted energy conversion device 1002 is a device that converts radio energy E transmitted from an external energy source 1004a installed in an external energy transfer device 1004 located outside the skin 1005 of a patient to an energy conversion device 1002 As shown in FIG.

As is well known in the art, wireless energy E is transmitted to a device (not shown) that includes a primary coil disposed in an external energy source 1004a and a secondary coil disposed in an implanted energy conversion device 1002 adjacent thereto Or by any suitable transcutaneous energy transfer (TET) device, such as a < RTI ID = 0.0 > When current is supplied through the primary coil, the voltage energy is induced in the secondary to power the implanted energy-utilizing element of the device, for example, into an implanted energy source such as a rechargeable battery or capacitor After storing the energy, the power is supplied. However, the present invention is not limited to any particular energy transfer technique, TFT device or energy source, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may be compared to the energy used by the implanted elements of the device. The expression "used (used) energy" is understood to include energy stored by the implanted elements of the apparatus. The control apparatus includes an external control unit 1004b that controls the external energy source 1004a based on a predetermined energy balance to adjust the amount of energy to be delivered. The energy balance and the amount of energy required are determined by a determination device comprising an implanted internal control unit 1015 connected between the switch 1026 and the implant device 10 to deliver the correct amount of energy. The internal control unit 1015 may measure various characteristics of the implant 10 by measuring any of the measurements taken by any suitable sensor (not shown), which measures the desired characteristics of the implant 10 and indicates the amount of energy required for proper operation of the implant 10 Lt; / RTI > Further, the current state of the patient may be detected by an appropriate measuring device or sensor so as to provide a parameter indicative of the state of the patient. These features and / or parameters may be determined by the current state of the implant 10, such as the current state of the implant 10, such as power consumption, mode of operation, temperature, etc. and parameters such as body temperature, blood pressure, heart rate, It may be related to the condition of the patient. Physical parameters of other types of patients and functional parameters of the device are also disclosed herein.

An energy source such as the capacitor 1016 may also be connected to the implanted energy conversion device 1002 via the control unit 1015 to accumulate the received energy for later use in the implantation device 10. Alternatively, or additionally, the characteristics of such a capacitor indicating the amount of energy required may also be measured. The capacitor may be replaced by a rechargeable battery and the measured characteristic may be related to the current state of the battery, any electrical parameters such as energy usage voltage, temperature, and the like. In order to provide sufficient voltage and current to the implanted device 10 and to avoid excessive overheating, the battery may be supplied by receiving the correct amount of energy from the implanted energy conversion device 1002, i.e., not too much, not too little You will see that it should be optimally absorbed. The capacitor may be a capacitor with a corresponding feature.

For example, the battery characteristic may be regularly measured to determine the current state of the battery and stored as state information in appropriate storage means within the internal control unit 1015. [ Therefore, whenever the new measurement is made, the stored battery state information can be updated. This allows the battery to be " calibrated "by conveying an accurate amount of energy, thereby maintaining the battery in an optimal condition.

Thus, the internal control unit 1015 of the judging device can be used to measure a measurement made by the sensor or measuring device or patient of the implanting device 10, or by an implanted energy source (if this energy source is used) (Energy or accumulated energy per unit of time) based on the energy balance and / or the presently required amount of energy. The internal control unit 1015 is connected to an internal signal transmitting unit 1027 which transmits a control signal indicating the necessary amount of energy determined by the judgment to the external signal receiving unit 1004c connected to the external control unit 1004b. The amount of energy transferred from the external energy source 1004a may be adjusted in accordance with the received control signal.

Alternatively, the determination device may include an external control unit 1004b. In this example, the sensor measurement value can be directly transmitted to the external control unit 1004b, and by determining the energy balance and / or the presently necessary energy amount by the external control unit 1004b, the function of the internal control unit 1015 To the external control unit 1004b. In this case, the internal control unit 1015 need not be provided, and the sensor measurement value is directly provided to the internal signal transmitting unit 1027. [ The internal signal transmitting unit transmits the measured value to the external signal receiving unit 1004c and the external control unit 1004b. The energy balance and the presently required amount of energy can be determined by the external control unit 1004b based on these sensor measurements.

The solution according to the apparatus of FIG. 50 is more efficient than the previous solution by using feedback of information indicating the required energy, which is the actual energy usage compared to the received energy, for example, The energy difference, or the energy reception ratio, which is compared with the energy ratio used by the < / RTI > The implantation device 10 may use the received energy for energy consumption or energy storage of the implanted energy source or the like. The various parameters described above can be used when relevant and necessary, and will eventually be used as a tool to determine the actual energy balance. These parameters may be needed for any action taken internally to operate the device specifically.

The internal signal transmitting unit 1027 and the external signal receiving unit 1004c may be implemented as separate units using appropriate signal transmitting means such as a radio wave signal, an infrared (IR) signal, or an ultrasonic signal. Alternatively, the internal signal transmitting unit 1027 and the external signal receiving unit 1004c may use the same transmission technique to transmit the control signal in the opposite direction to the energy transfer, Respectively, in the energy source 1004a. The control signal can be modulated with respect to frequency, phase or amplitude.

Thus, the feedback information may be conveyed by a separate communication system comprising a receiver and a transmitter, or may be integrated into an energy system. According to the present invention, this integrated information feedback and energy system comprises an implantable internal energy receiver for receiving radio energy, the internal energy receiver comprising a first electronic circuit connected to the first coil and the first coil, And the energy transmission unit includes a second electronic circuit connected to an external second coil and a second coil. The second coil outside the energy transmission unit transmits the wireless energy received by the first coil of the energy reception unit. The system further includes a power switch for turning on and off the connection of the first internal coil to the first electronic circuit so that feedback information relating to charging of the first coil is transmitted to the first coil Is switched on and off by the external energy transmission unit in the form of a change in the impedance of the load of the external second coil. In implementing the present system in the apparatus of FIG. 50, the switch 1026 is separately controlled by the internal control unit 1015, or integrated into the internal control unit 1015. The switch 1026 should be interpreted as having a broad meaning. That is, power can be turned on / off using a transistor, an MCU, an MCPU, an ASIC, an FPGA, a DA converter, or any other electronic device or circuit.

Consequently, the energy supply device shown in Fig. 50 can basically operate in the following manner. First, the energy balance is determined by the internal control unit 1015 of the determination apparatus. The internal control unit 1015 generates a control signal indicating the required energy amount, and the control signal is transmitted from the internal signal transmitting unit 1027 to the external signal receiving unit 1004c. Alternatively, the external control unit 1004b may determine the energy balance. In this case, the control signal can convey the measured value sensed by the various sensors. The amount of energy emitted from the external energy source 1004a can be adjusted by the external control unit 1004b, for example, in accordance with the received control signal, based on the determined energy balance. This process may be repeated intermittently at regular intervals during energy transfer, or may be performed more continuously or less continuously during energy transfer.

It is common that the amount of energy delivered can be controlled by adjusting various transmission parameters within the external energy source 1004a, such as voltage, current, amplitude, propagation frequency and pulse characteristics.

The system may also be used to obtain information about the coupling coefficient between the coils in the TET system to determine the optimal position of the outer coil associated with the inner coil and to calibrate the system to optimize energy transfer. In this case, the amount of energy transferred is compared with the amount of received energy. For example, in the case of moving the outer coil, the coupling coefficient can be changed, and by the precisely marked movement, the outer coil can obtain the optimum position for energy transfer. Preferably, the amount of energy transferred by the outer coil is corrected so that feedback information can be obtained in the determination device before the coupling coefficient becomes maximum.

This coupling coefficient may be used as feedback of the energy transfer process. In this case, the energy system of the present invention includes an implantable internal energy receiver for receiving radio energy and an external energy transmitter for transmitting radio energy. The energy receiving unit includes a first electronic circuit connected to an inner first coil and a first coil. The external energy transmitting portion includes a second electronic circuit connected to an external second coil and a second coil. The second coil outside the energy transmission unit transmits radio energy received by the first coil of the energy reception unit. The system further includes a feedback device for externally transmitting the amount of energy received by the first coil as feedback information. The second electronic circuit receives the feedback information and compares the amount of energy delivered by the second coil with the feedback information related to the amount of energy received at the first coil to determine the coupling coefficient between the first coil and the second coil And a judgment device for obtaining the judgment result. The energy transmission unit can adjust the transmitted energy according to the acquired coupling coefficient.

Referring to FIG. 51, although implantation device 10 is described as being capable of non-invasive operation by the transfer of radio energy for operation of implant 10, it may also be operated by wired energy. An example thereof is shown in Fig. 51, an external switch 1026 is connected between an external energy source 1004a and an operating device, such as an electric motor 1007, which operates the implanting device 10. [ The external control unit 1004b controls the operation of the external switch 1026 to allow the implant device 10 to operate properly.

52 shows an embodiment of a method of supplying the received energy to the implantation apparatus 10 and a method used by the implantation apparatus 10. Fig. 50, the internal energy receiving unit 1002 receives radio energy E from an external energy source 1004a controlled by the transfer control unit 1004b. The internal energy receiving unit 1002 may include a constant voltage circuit that supplies a constant voltage to the implant device 10 and is represented by "constant voltage V" in the drawing. The internal energy receiving unit 1002 may include a constant current circuit for supplying a constant current energy to the implantation apparatus 10, which is denoted as "constant current C" in the drawing.

The implanted device 10 includes an energy use component 10a that can be a motor, a pump, a restrictor, or any other medical device that requires energy for electrical operation. The implantation apparatus 10 may further include an energy storage device 10b for storing energy supplied from the internal energy receiving unit 1002. [ Therefore, the supplied energy can be directly used by the energy using component 10a or can be stored in the energy storage device 10b. Some of the supplied energy can be used and some can be stored. The implantation apparatus 10 may further include an energy stabilization unit 10c for stabilizing the energy supplied from the internal energy receiving unit 1002. [ Thus, the energy may be supplied in a variable manner so that it may be needed to stabilize the energy before it is used or stored.

The energy supplied from the internal energy receiver 1002 may be stored and / or stored in a separate energy stabilization unit 1028 located outside the implant 10 before being used and / or stored by the implant 10, Lt; / RTI > Alternatively, the energy stabilization unit 1028 may be integrated within the internal energy receiver 1002. [ In either case, the energy stabilization unit 1028 may comprise a constant voltage circuit and / or a constant current circuit.

It should be noted that Figures 50 and 52 illustrate some possible but non-limiting implementations of how the various functional components depicted are arranged and how they are interconnected. It will be readily apparent to those skilled in the art that many modifications and variations are possible within the scope of the invention.

Figure 53 schematically shows one energy balance measurement circuit, i.e., an energy balance control system, in a proposed design of a system for controlling the transmission of radio energy. The energy balance measurement circuit is tuned to 2.5V and has an associated output signal proportional to the energy imbalance. The derivative of this output signal shows how the values rise and fall and how quickly these changes occur. If the amount of energy received is less than the amount of energy used by the implanted component of the device, more energy is delivered and more energy is charged to the energy source. The output signal from this circuit is typically supplied to an A / D converter and converted to digital form. Thus, the digital information can be transmitted to an external energy delivery device to control the level of transmitted energy. Another possibility is that you can have a complete analog system using a comparator. The comparator compares the energy balance levels with predetermined maximum and minimum thresholds and transmits information to the energy delivery device when the energy balance is outside the maximum and minimum thresholds.

Figure 53 shows a circuit implementation of a system for transferring energy from the outside of a patient's body to an implanted energy utilizing element of the device of the present invention using inductive energy transfer. The inductive energy transfer system generally uses an external transfer coil and an internal receiving coil. Although the receiving coil L1 is schematically shown in Fig. 53, the transmitting coil is not shown.

The general concept of energy balance and the implementation of the method of conveying information to the external energy transmitter can be implemented by many different methods. The above-described method of evaluating and delivering the information and the information is only an example for implementing the control system.

Detailed description of the circuit

In Fig. 53, reference symbols Y1, Y2, Y3, etc. denote test points in the circuit. The elements and their values in the figures are values that work in a particular implementation that is only one of many possible design options.

Energy to operate on the circuit is received by the energy receiving coil L1. The energy for the implanted element, in this case, is transmitted at a frequency of 25 kHz. The energy balance output signal is at test point Y1.

Those skilled in the art will appreciate that the various embodiments of the system may be combined in many different ways. For example, the electrical switch 1006 of FIG. 36 may be included in any of the embodiments of FIGS. 39 to 45, and the hydraulic valve switching device 1014 of FIG. 39 may be included in the embodiment of FIG. 38 And the gear box 1024 may be included in the embodiment of Fig. The switch may be any electronic circuit or component.

The embodiments described with respect to Figures 50, 52, and 53 provide a method and system for controlling the transfer of wireless energy to an implanted energy-utilizing element of an electrically-operable device. Such a method and system can be defined as a general expression as follows.

As described above, there is provided a method for controlling the transfer of wireless energy to an implanted energy-utilizing element of an implantable device. The wireless energy (E) is transmitted from an external energy source external to the patient and is received by an internal energy receiver located within the patient ' s body. The internal energy receiver is connected to the implanted energy consuming element of the device and supplies the received energy directly or indirectly to this energy consuming element. The energy balance is established between the energy received by the internal energy receiver and the energy used in the device. With this determined energy balance, the transmission of the radio energy E from the external energy source is controlled.

Wireless energy can be delivered inductively from the primary coil in the external energy source to the secondary coil in the internal energy receiver. In order to control the transmission of radio energy based on a predetermined energy balance change, a change in the energy balance can be detected. It is possible to detect an energy difference between the energy received by the internal energy receiving unit and the energy used in the medical equipment and to control the transmission of the wireless energy based on the detected energy difference.

When controlling energy transfer, it is possible to reduce the amount of radio energy transmitted when the energy balance is increasing by detection of a change in the energy balance, and conversely, by detecting a change in the detected energy balance, The amount of wireless energy to be transmitted can be increased. The decrease / increase of the transmitted energy may correspond to the detected change rate.

If the energy received by the detected energy difference indicates that the energy received is greater than the energy used, the amount of radio energy transmitted may be increased and conversely the energy received by the detected energy difference is less than the energy used The amount of wireless energy to be transmitted can be reduced.

As described above, the energy used in the medical device may also be used to operate the medical device and / or to store it in one or more energy storage devices of the medical device.

Once the electrical and / or physical parameters of the medical device and / or the patient's physical parameters have been determined, energy may be transferred for use and storage according to the rate per time unit determined based on these parameters. The total amount of energy transferred may be determined based on these parameters.

Detecting a difference between the total amount of energy received by the internal energy receiver and the total amount of used and / or stored energy, and determining whether the detected difference is an integral over time of the measured electrical parameter time, this integral may be that determined for the monitored voltage and / or current associated with the energy balance.

If a derivative over time of the measured electrical parameter associated with the amount of energy used and / or stored is determined, then this differential may be that determined for the monitored voltage and / or current associated with the energy balance.

The transmission of radio energy from an external energy source is achieved by applying an electrical pulse having a leading edge and a trailing edge from a first electrical circuit to an external energy source and applying a first The length of the time interval and / or the length of the second time interval between successive trailing and leading edges of the electric pulse, and transmitting the wireless energy. The energy generated and transmitted from the electric pulse can be changed in power, and the power change depends on the length of the first and / or second time interval.

In this case, the frequency of the electric pulses may be substantially constant even when the first and / or second time interval is varied. In the case of applying an electric pulse, the electric pulse can be kept constant except in the case of varying the first and / or second time interval. The amplitude of the electric pulses may be substantially constant, except when varying the first and / or second time interval. The electric pulses may also be varied by changing only the length of the first time interval between successive leading edges of the electric pulses and the trailing edge.

Two or more series of electrical pulses may be supplied continuously and in the case of applying a series of pulses the pulse train comprises a first electrical pulse at the beginning and a second electrical pulse at the end of the pulse train, Two or more pulse trains may be fed in succession, wherein a second time interval between the trailing edge of the second electric pulse in the first pulse train and the leading edge of the first electric pulse of the second pulse train The length can vary.

In the case of applying an electric pulse, the electric pulse may have a substantially constant current and a substantially constant voltage. The electric pulses may have a substantially constant current and a substantially constant voltage. Further, the electric pulses may have a substantially constant frequency. Electric pulses in the pulse train may likewise have a substantially constant frequency.

The circuit formed by the first electrical circuit and the external energy source may have a first feature time period or a first time constant and, in the case of effectively varying the energy delivered, such a frequency time period may be a first feature time period or Within a range of time constants or within a shorter range.

A system including the apparatus described above is provided for controlling the transfer of wireless energy supplied to an implanted energy-using element of the apparatus. Broadly, the system includes a control device for controlling the transfer of radio energy from the energy delivery device and an implantable internal energy receiver for receiving the transmitted radio energy. The internal energy receiver is connected to an implantable energy utilization component of the device and directly or indirectly supplies the received energy to the implantable energy utilization component. The system may further comprise a determination device configured to determine an energy balance between the energy received by the internal energy receiver and the energy used in the implantable energy usage element of the device. The control device controls the transfer of radio energy from the external energy transfer device based on the energy balance determined by the determination device.

In one example, one or more batteries may replace or replace part of the energy conversion device 1002 to supply energy to the implantation device 10 through a power supply line. As another example, the battery may be rechargeable. The power supply of the battery may be disposed at a position away from the apparatus or may be included in the apparatus.

The system may also include any of the elements described below.

A primary coil in an external energy source configured to inductively deliver radio energy to a secondary coil in an internal energy receiver.

The determination device is configured to detect a change in the energy balance. The control device controls the transfer of radio energy based on the change in the detected energy balance.

The determination device is configured to detect a difference between the energy received by the internal energy receiver and the energy used in the implantable energy usage element of the device. The control device controls the transfer of radio energy based on the detected energy difference.

The control device controls the external energy transfer device to reduce the amount of radio energy delivered when the change in the detected energy balance indicates that the energy balance is increased and that the change in the detected energy balance results in an energy balance The external energy transfer device is controlled to increase the amount of radio energy transmitted. The increase / decrease of the amount of energy delivered corresponds to the amount of change detected.

The control device controls the external energy transfer device to reduce the amount of wireless energy transmitted if the detected energy difference indicates that the received energy is greater than the used energy; If the detected energy difference indicates that the received energy is less than the energy used, the external energy transfer device is controlled to increase the amount of radio energy transmitted. The increase / decrease of the delivered energy amount corresponds to the magnitude of the detected energy difference.

- The energy used in the device is used to operate the device, and / or to be stored in one or more energy storage devices of the device.

When the electrical and / or physical parameters of the device and / or the physical parameters of the patient are determined, the energy delivery device transmits energy for use and storage according to the delivery rate per unit of time determined by the determination device based on these parameters do. The determination device determines the total amount of energy transferred based on these parameters.

A difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy used and / or stored, and this detected difference is related to the time integral of the measured electrical parameter If so, the determination device determines that it is an integral to the monitored voltage and / or current associated with the energy balance.

If the time-dependent derivative of the measured electrical parameter related to the amount of used and / or stored energy is determined, the determining device determines that this differentiation is for the monitored voltage and / or current associated with the energy balance .

The energy delivery device includes an outer coil located outside the human body and an electrical circuit supplying power to the outer coil with electrical pulses delivering radio energy. The electrical pulse has a leading edge and a trailing edge, and the electrical circuit has a first time interval between successive leading edges and a trailing edge, and / or a second trailing edge between successive trailing edges of the electrical pulse and a leading edge And is configured to change the power of the transmitted wireless energy by changing the interval. Therefore, the energy receiving unit that receives the transmitted wireless energy has a changed power.

The electric circuit delivers an electric pulse so as to remain constant, except for the first and / or second time interval.

- the electrical circuit has a time constant and, by varying the first and second time intervals only within a first time constant, when the length of the first and / or second time interval changes, Allow the power to change.

The electrical circuit carries electrical pulses that change by changing only the length of the first time interval between successive leading edges of the electrical pulses and the trailing edge.

The electric circuit is configured to continuously supply heat of two or more electric pulses. The pulse train has a first electrical pulse at the beginning and a second electrical pulse at the end.

The length of the second time interval between the trailing edge of the second electric pulse in the first pulse train and the leading edge of the first electric pulse in the second pulse train is changed by the first electric circuit.

The electric circuit provides the electric pulse as a pulse having a substantially constant height, amplitude, intensity, voltage, current and / or frequency.

The electrical circuit has a time constant and the length of the first and / or second time interval is varied by varying the first and second time intervals only in the range of the first time constant, so that the power delivered through the first coil .

The electrical circuit comprises a first time constant or provides an electrical pulse that changes the length of the first and / or second time interval only within a range relatively close to the first time constant relative to the magnitude of the first time constant do.

Figures 54-57 show in block diagram form four different methods of supplying hydraulic or pneumatic power to an implant according to an embodiment of the present invention.

54 shows a system as described above. The system includes the implant device 10 and further includes a separate fluid reservoir 1013, a one-way pump 1009, and a switching valve 1014.

55 shows the implant device 10 and the fluid reservoir 1013. Fig. By adjusting the implant device 10, the fluid can flow freely at any time, without a valve, by moving the wall of the fluid reservoir or by changing the size of the fluid reservoir in any other manner.

56 shows the implant device 10, bidirectional pump 1009 and fluid reservoir 1013. Fig.

57 shows a block diagram of an inverted subsystem having a first closed system for controlling a second closed system; The servo system includes a fluid storage unit 1013 and a servo storage unit 1050. The servo storage unit 1050 mechanically controls the implantation apparatus 10 by a mechanical connection unit 1054. [ The implant device 10 has an expandable / contractible cavity. This cavity is preferably inflated or deflated by supplying a hydraulic fluid from the larger adjustable reservoir 1052 by fluid connection with the implant 10. Alternatively, the cavity contains a compressible gas that is compressible and expandable under the control of the servo storage 1050.

The servo storage unit 1050 may be a part of the implantation apparatus.

In one embodiment, the fluid reservoir is located under the patient ' s skin and operates by pressing its outer surface with a finger. This system is shown in Figs. 58A to 58C. 58A, the flexible subcutaneous fluid reservoir 1013 is shown connected to the sub-reservoir 1050 in a convex shape by the conduit 1011. In Fig. This bellow shaped sub-storage 1050 is contained within the flexible implant 10. In the state shown in Fig. 58A, the servo storage section 1050 contains a minimum amount of fluid, and most of the fluid is in the fluid storage section 1013. [ The servo storage unit 1013 and the implantation apparatus 10 are mechanically connected, so that the external shape of the implantation apparatus 10 can be contracted. That is, in this case, the implant apparatus 10 becomes smaller than its maximum volume. The maximum volume is indicated by a dotted line in the figure.

58B shows a state in which the fluid stored in the fluid reservoir is introduced into the conduit (not shown) by the user such as the patient to which the implant device 10 is implanted by pressing the fluid reservoir 1013 and the fluid reservoir expands in the longitudinal direction by the pleated form. 1011) to the servo storage unit (1050). This swelling inflates the implant 10 so that the implant 10 is at its maximum volume, thereby extending the stomach wall (not shown) in contact with the device.

The fluid reservoir 1013 preferably includes means 1013a for maintaining its shape after compression. This is to allow the implant device 10 to maintain its extended position even when the user is relieved of pressing the fluid reservoir, as schematically shown in the figure. According to this, the fluid reservoir operates as an on / off switch used in the system.

An embodiment relating to a hydraulic or pneumatic operation will be described with reference to Fig. 59 and Figs. 60A to 60C. The block diagram of Figure 59 includes a first closed system for controlling a second closed system. The first closed system includes a fluid reservoir 1013 and a servo reservoir 1050. The servo storage unit 1050 mechanically controls the larger adjustable storage unit 1052 by the mechanical connection unit 1054. The implanting device 10 having an inflatable / retractable cavity is configured by a larger adjustable reservoir 1052 by supplying hydraulic fluid from the adjustable reservoir 1052 by fluid connection with the implant device 10 Respectively.

This embodiment will be described with reference to Figs. 60A to 60C. As in the previous embodiment, the fluid reservoir is located below the patient ' s skin and operates by pressing the outer surface with a finger. The fluid storage portion 1013 is fluidly connected to the servo storage portion 1050 having a corrugated shape by the conduit 1011. In the first closed system 1013, 1011, 1050 shown in FIG. 60A, the servo storage unit 1050 contains a minimum amount of fluid, and most of the fluid is in the fluid reservoir 1013.

The servo storage unit 1050 is mechanically connected to the larger adjustable storage unit 1052. In this example, the storage unit 1052 has a wrinkled shape and is larger in diameter than the servo storage unit 1050. The adjustable reservoir 1052 is fluidly connected to the implant 10. That is, when the user presses the fluid storage part 1013, the fluid moves from the fluid storage part 1013 to the servo storage part 1050 and the servo storage part 1050 expands, whereby the adjustable storage part 1052 A greater amount of fluid is transferred to the implant device 10. [ In other words, in this reversal situation, a small amount of fluid in the fluid reservoir is compressed with greater force, resulting in a larger area of movement with less force.

Similar to the embodiment described with reference to Figures 58a-58c, the fluid reservoir 1013 preferably includes means 1013a for maintaining its shape after compression. This is to allow the implant device 10 to maintain its extended position even when the user is released from pressing the fluid reservoir, as schematically shown in the figure. According to this, the fluid reservoir operates as an on / off switch used in the system.

* While the various elements described above are shown as having particular arrangements in the figures, it will be understood that their location may vary depending upon the application.

It is preferable that the lubricant used in the embodiment of the present invention is a lubricant suitable for a living body mimicking a natural mucus of the hip joint.

It will be appreciated that, in various embodiments, one or more channels may be connected directly to the reservoir or injection port without having a conduit. Various embodiments, or portions thereof, as well as any method, or portions thereof, may be combined in various ways. It is to be understood that all examples are part of the general description and may be combined in any manner in the usual manner. The specification is intended to describe an apparatus and method.

The various features of the invention described above may be combined in any number of ways, as long as they are not specifically contradictory. The invention has been described as a preferred embodiment and with reference to the accompanying drawings. Each feature of the various embodiments is capable of being combined or altered and such combinations or changes are possible without departing from the overall functionality of the apparatus.

Claims (15)

An implantable medical device for implantation in a patient's hip,
A concave artificial acetabular interface 65 that replaces the surface of the acetabular interface and is adapted to be lubricated when implanted in the hip joint;
A container 1108 for holding the lubricant;
At least one inlet (1123) configured to receive a lubricant from the container;
At least one channel (1105) at least partially integral with the concave artificial acetabular interface, the channel being in fluid communication with at least one inlet for dispensing the lubricant to a surface of the concave artificial acetabular interface;
An actuating device (1007) configured to non-invasively transport said lubricant from said container to said artificial acetabular interface to lubricate said artificial acetabular interface; And
An implantable injection port 1107 for refilling the container,
And an implantable medical device. The method according to claim 1,
Wherein the container is configured to be pre-filled with a compressed lubricant. 3. The method according to claim 1 or 2,
The operating device includes:
a. Energized operating devices,
b. An electric operating device, and
c. (P) 1009 configured to pump the lubricant from the container to the artificial acetabular interface to lubricate the artificial acetabular interface,
Of the implantable medical device. 3. The method according to claim 1 or 2,
Further comprising a valve configured to close a connection between the container and the artificial acetabular interface. 3. The method according to claim 1 or 2,
Wherein the container is located in a unit separate from the artificial acetabular interface and is configured to be connected to the artificial acetabular interface via a conduit. 3. The method according to claim 1 or 2,
Wherein the container comprises a movable wall portion (110) for varying the volume of the container. 3. The method according to claim 1 or 2,
The implantable medical device
At least one outlet (131), and at least one additional channel at least partially integrated with the artificial acetabular interface,
To allow circulation of lubricant through the outlet through the artificial acetabular interface and into the artificial acetabular interface through the inlet (130). 3. The method according to claim 1 or 2,
a. An operating device 1107 configured to circulate the lubricant,
b. A container configured to add liquid to the circulating lubricant, and
c. A filter 132 configured to clean the circulating lubricant,
≪ / RTI > 3. The method according to claim 1 or 2,
The container
a. At least partially positioned within the bone of the patient,
b. Positioned at least partially within the pelvic bone of the patient,
c. Subcutaneously, or in a cavity in the body,
d. Subcutaneous, or intra-abdominal region, ii) a groin region, iii) a pelvic region, and iv) a thigh region,
e. Located in the abdomen,
f. Implanted subcutaneously, and
g. Implanted in connection with bones
The implantable medical device being configured to be at least one of: 3. The method according to claim 1 or 2,
Wherein the container is configured to provide pressure to the lubricant. 11. The method of claim 10,
The container may include:
a. Loaded by spring 1109
b. Including a chamber (GAS) configured to hold a compressed gas,
c. Including an elastic wall configured to generate pressure,
d. Containing parylene-coated silicone elastic walls
Of the implantable medical device. 3. The method according to claim 1 or 2,
At least one switch (1006) operable to passively and non-invasively control the implantable medical device and implantable in a patient, a wireless remote control, and a controller operatively connected to the implantable medical device RTI ID = 0.0 > 1013 < / RTI >
Wherein the implantable medical device comprises: 3. The method according to claim 1 or 2,
System,
The system
An internal energy source for applying electrical power to the implantable energy consuming components of the implantable medical device (10); And
An internal energy source (1002) configured to non-invasively and wirelessly supply energy from an outside of a patient's body by means of an energy delivery device (1004)
An implantable internal energy source included in the system that is chargeable by energy transferred from the energy delivery device, and
At least one implantable energy-consuming component of a system for energizing wireless energy
To transmit wireless energy to at least one of the inner energy source
≪ / RTI > 14. The method of claim 13,
A system further comprising a sensor and / or a measuring device,
The measuring device
At least one physical parameter of the patient; And
At least one functional parameter associated with the implantable medical device, the functional parameter comprising at least one of a functional parameter associated with energy transfer for filling an internal energy source and a functional parameter associated with the implantable medical device,
Or < / RTI >
The implantable medical device may be placed within the body of a patient
- an implantable internal control unit,
- an external control unit external to the patient's body,
- an external control unit which is external to the patient's body, via an internal control unit,
- via an internal control unit in accordance with the programming of the internal control unit performed by the external control unit,
Further comprising a feedback device for transmitting feedback information,
Wherein the feedback information is associated with at least one of a functional parameter associated with the implantable medical device and at least one physical parameter of the patient. 3. The method according to claim 1 or 2,
Wherein the actuating device is a pre-pressurized container configured to move lubricant from the container to the artificial acetabular interface to lubricate the artificial acetabular interface.

Images