KR102120304B1 - Implantable Lubrication Device - Google Patents

Abstract

A lubricating device for lubricating joints of a human or mammalian patient that is entirely implantable in a patient's body, comprising a container for storing lubricating fluid and a fluid connection for introducing lubricating fluid into the joint when the device is implanted into the patient's body. In addition, the fluid connection portion comprises a fluid connection device for connecting the container to the joint, the flow of lubricant from the container into the joint is established. The fluid connection comprises one of an injection needle that is intermittently positioned into the joint to inject lubricant, or a tube permanently positioned into the joint to continuously inject lubricant.

Description

Implantable Lubrication Device

The present invention relates to an implantable lubrication device for smoothing a joint of a human or mammalian patient, a lubrication system, and a method of treating a human or mammalian patient with the implantable lubrication system.

The present invention is particularly suitable for the introduction of lubricating fluid into the joints periodically or for a long period of time, for example, fixedly or over a long period of time over several years.

The synovial fluid (synovial fluid) reduces friction between artificial cartilage and other tissues in the joint, and lubricates and absorbs the tissue components and bones of the joint during udon. In most cases of aging, and/or excessive or abnormal compression in human or mammalian joints (e.g., knee joints, hip joints), the lubricating fluid is negatively affected, or joint artificial cartilage covering the joint bone as a whole is damaged Once done, it can lead to degenerative joint disease (also known as osteoarthritis) characterized by painful inflammation of the joints. When the composition of the lubricating fluid changes and pathologically decreases in the joints composed of joint bones and joint surfaces of joints and adjacent bones that are wrapped and stabilized by the joint capsule, the lubricating fluid no longer has its usual role, namely articular cartilage. With (articular cartilage), it is impossible to perform the lubrication and shock absorption of the joints.

When osteoarthritis or the like, the articular cartilage is also severely damaged, and/or the articular fluid decreases or its composition changes, thereby reducing its ability to reduce friction within the joint, the joint surface increases high friction and increases painful inflammation. Wear. This places significant constraints on behavior, especially on walking or standing posture, which further increases the degenerative process of the joints. Degenerative arthritis is a very common disease in the West, and it has become one of the leading causes of chronic disorders in Europe and the United States.

Osteoarthritis patients require periodic long-term treatment, where lubricating fluid is introduced into the injured joint, which, on the one hand, restores the physical function of the injured joint as much as possible, and on the other hand, physical and psychological to the patient. In all respects, try to get as little external stress as possible.

A known standard therapy is to inject synthetic lubricating fluid periodically into the joint space by means of a syringe to replace the non-existent physiological lubricant. In such conventional treatments, the patient has the inconvenience of delivering lubricant to the inside of the joint through the skin and joint sac by a syringe at regular time intervals. In addition, it can injure the skin and joint sac, which increases the risk of severe infection of sensitive joint tissue. Therefore, the injection cannot be performed more often than once every half year.

However, many patients require more frequent injection of lubricant, for example, continuous artificial injection of a small amount of lubricant.

Accordingly, the present invention is intended to propose an improved technique for lubricating damaged or worn joints of a patient or a mammalian patient, on the one hand, sufficiently lubricating the joint and, on the other hand, a minimal risk of infection. Eggplant is intended to suggest an improved technique.

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

The implanted lubrication system according to the present invention comprises an implanted lubrication device and a lubricant stored in its container, which is introduced into the joint by its fluidic connection.

More essential or optional parts of the implantable lubrication device may also be fully implanted into the patient's body, such as a container, pump or motor, energy source, control unit, and the like. Such parts may belong to an implantable injection device, or may form an integral part of an implantable lubrication system, separate from the actual implantable injection device. Since the implantable device can be implanted entirely into the patient's body, that is, it provides both the ability to store and transport the lubricant in the patient's body, the complete supply path of lubricant to lubricate the joint is the patient Is in the body. Therefore, there is no longer a need for in vitro injection into the joint.

The fluid connection includes a fluid connection device that connects the container of the implantable infusion device to the joint, thus establishing a supply path of lubricant from the container to the joint. The fluid connection device is also completely implantable, and thus preferably consists of a flexible tube or the like suitable for post-surgical transport of the lubricant stored in the container to the joint.

In addition, the fluid connection portion includes an injection member connected to the fluid connection device. The infusion member may be introduced into the patient's body at the location inside the joint or at a location very close to the joint during surgery, and thus, after surgery, the lubricant may be introduced into the joint. It can be configured to periodically or intermittently inject the lubricant into the joint when the level of the lubricant drops below a certain threshold, depending on the sensor data and driven by the drive mechanism. Alternatively, and preferably, the injection member may also be configured to continuously inject the lubricant into the joint, such as a predetermined amount of lubricant per unit time, for example, one drop per hour.

During the operation, intermittent injection may be performed by an injection needle or the like, which is disposed close to the joint, and thus, it may be made in a manner of intermittently progressing in the forward direction into the joint after surgery by a driving mechanism, and then retracting thereafter. Thus, it is possible to enable intermittent lubrication of the joint through the tip of the injection needle. The drive mechanism is configured to advance and retract the tip of the injection needle into and out of the joint. The drive mechanism may be present separately from the injection needle and/or fluid connection device, but it may also be configured as part of the entirety of an implantable lubrication device that is entirely implanted into the patient's body.

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

Preferably, the container of the implantable lubrication device may include a container connected to the fluid connection device for storing the lubricant. Usually, the lubricant is stored in a container. The container may consist of a separate part of the implantable lubrication device, which is independently implanted into the patient's body. In order to establish the proper flow rate of lubricant into the joint, the container can be configured to change its volume to create an appropriate pressure in the fluid connection device and in the injection member for transporting the lubricant into the joint.

Thus, at least a portion of the periphery of the container is used to change the volume of the container by deformation of the container fluid material as the lubricant is filled in or discharged therefrom, and through the fluid connection device to flow fluid from the container to the joint. It may include a flowable outer wall for raising.

Therefore, the container may be of a balloon type. The flowable material may include a polymer membrane. To reduce long-term performance degradation, bellows structures with pre-folded wrinkles are preferred. Directing fluid from the container into the fluid connection device and into the joint will cause a pressure drop in at least a portion of the container, so that it has a negative pressure relative to the pressure in front of the injection tube or injection needle at the connection end of the fluid connection device. Is formed. For example, the canopy may comprise a gas chamber or a fluid chamber, the chambers being separated by a membrane, eg polymux, and thus acting as a spring to change the volume of the container, and thus the The pressure in the gas chamber will decrease as the lubricant enters the fluid connection device from the fluid chamber.

The container can also have a replenishment infusion port for replenishing the lubricating fluid from outside the human body into the implanted container. Thus, the container implanted into the patient's body together with the fluid connection device can be kept in a small size because the container can be easily replenished at appropriate time intervals. Preferably, the infusion port comprises a self-sealing material for penetration caused by artificial injection syringes, which are mainly used to replenish the container through the patient's skin. It is preferred to implant the container of the lubrication device, or at least to implant the container's self-sealing injection port subcutaneously into the patient, so that it can be easily replenished by the syringe means.

To introduce lubricant into the patient's joint through the fluid connection device and injection needle or infusion tube, the container can be manually compressed, while a pump is connected to the fluid connection device and it is connected to the container and the injection member. It is preferred to pump the lubricating fluid from the container into the joint by connecting between them. By means of a pump, the exact dosage of the lubricant can be easily calculated, so that an appropriate amount of lubricant can be supplied into the joint 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 forming a sealable contact between the first and second valve members Thus, they have smooth surfaces that face each other, and also have different fluid channels that can be arranged by deformation of two smooth surfaces relative to each other, while maintaining the sealing contact. Pumps of this type are described in very detail in WO2004/012806 A1. The first and second valve members are preferably made of a ceramic material for long-term good sealing properties and durability to many elements. The pump may be a membrane type pump, which is also well described in WO2004/012806 A1, but is not necessarily limited to this type. The membrane type pump may include a membrane that can be moved by the movement of the piston, and the piston is connected to the valve device so that as the piston moves, the first and second valve members slide relative to each other. Can be.

Preferably, the manual drive of one of the pumps or drive mechanisms simultaneously drives the other, ie the drive mechanism or pumps. For example, the pressure exerted by the pump can cause the drive mechanism to advance the infusion needle when the injection fluid is delivered through the needle tip into the patient's body, and when the pressure is released by the pump, the return spring ) Or other elastic member will retract the injection needle.

The implanted pump can be driven by a mechanical remote controller, or driven by a pressure sensing switch positioned to be manually operable when implanted subcutaneously in the patient's body, or by measuring the level of fluid in the joint to pump ( And a driving 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 falls below a predetermined threshold. Preferably, the drive of one of the pumps or drive mechanism drives the other, ie the drive mechanism or pump simultaneously. For example, the pressure exerted by the pump can cause the drive mechanism to advance the infusion needle when the injection fluid is delivered through the needle tip into the patient's body, and when the pressure is released by the pump, the return spring ) Or other elastic member will retract the injection needle.

At least one motor is provided to operate the pump and, if used, a drive mechanism for advancing and/or retracting the infusion needle into and out of the joint, and for direct or indirect flow of lubricant within the lubrication device into the joint. Can be. The motor may be configured to operate the pump and/or drive mechanism, for example, electrically, magnetically, or electromagnetically, or may operate the pump and/or drive mechanism hydraulically. Preferably, the motor can be configured to drive one of the pumps or drive mechanism, and accordingly drive the other, ie the drive mechanism or pump, at the same time. The motor can 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 manually applied force, and automatically converts such energy into kinetic energy, hydraulic energy, or another form of energy, or converts such energy into a pump, a driving mechanism, and And/or any directly used to activate other parts of the implanted lubrication device. Thus, in the case of an 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 separated from the lubrication device body and implanted in the patient body for separate implantation within the patient body, or contained within the lubrication device body. A connecting member for providing electrical or wireless energy to the motor from the outside of the device may be provided. For example, the motor can be configured to be configured wirelessly by an external electromagnetic field. It is also possible to use a primary or external energy source for use outside the patient's body, in particular an external energy source such as a rechargeable battery, which is placed on the patient's skin to pump and/or drive mechanism and/or lubrication device. It can supply energy to any other energy consuming portion of the. The energy source can be connected to at least a motor, in particular to activate the components. The external energy source for wireless energy transmission can 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 a sound wave signal.

When the energy is wirelessly transmitted to the implanted lubricating device, a conversion device for converting the wirelessly transmitted energy into electrical energy may be provided. Such a conversion device is preferably arranged to lie directly under the patient's skin, so as to minimize the amount and distance of tissue between the conversion device and an energy source member outside the patient's body.

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

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

Such an implantable energy source may preferably include a long-term useable 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 comprises a rechargeable battery and/or capacitor.

In addition, a connecting member for transmitting electrical or wireless energy from the primary energy source to the capacitor from outside of the device is provided to charge the capacitor when the device is implanted in the patient body, outside the patient body Can be.

Although a drive member for manually driving the motor may be provided on the at least one motor, it is preferable that a control unit for adjusting the at least one motor is also provided. The control unit can be used to adjust any other energy consuming portion of the pump, drive mechanism and/or implanted lubrication device, whereas if the device includes an external or internal energy source, that energy source It can also be used to control. The control unit can be controlled according to the needs of each patient, so that an appropriate amount of drug will be administered at appropriate time intervals. Automatic dosing will substantially free the patient.

Preferably, the control unit has a data transfer port for data transfer between an external data processing device outside the patient's body and a control unit implanted in the patient's body, which is included inside the body of the lubrication device. It is irrelevant whether it is present or is implanted in the patient's body separated from the body of the implant. The data transfer port allows the control unit to supervise the injection device to adapt to the changing needs of the patient. Preferably, the data transfer port is a wireless transfer port for data transfer, thus providing easy data conversion between the control unit and the data processing device, for example, while the patient is meeting a doctor. 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 in vitro, such as placed on the patient's skin. The external control unit has the advantage of being easily accessible in case of any failure. It is preferably applied for wireless remote control of at least one motor implanted with an injection device.

A control signal transmission device for wirelessly transmitting control signals from outside the body to the implanted motor may be provided. Similarly, a data delivery interface can be provided for wirelessly transferring data from outside of the patient's body to a control unit implanted within the patient's body. Further, the transmission of the radio control signal and/or data may include one of the above-mentioned wavelength signals, digital or analog, or a combination thereof. More preferably, the control signal may be transmitted in the same way as energy is transmitted to the motor. For example, the control signal can be delivered by modularization of the energy signal, so that the energy signal can act as a carrier wavelength signal for the digital or analog control signal. More preferably, the control signal may be a frequency, phase, and/or amplitude modulated signal.

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

Preferably, the fluid connection device consists of two fluid connections, each of which is connected to a container and has an injection member at its end to be inserted into the joint space. The two fluid connections can be placed in the patient's body, and thus, postoperatively, a circulating flow path through the joint of the lubricant, ie a path from the pump and/or vessel to the joint (via the first fluid connection) And a return path (via the second fluid connection) to the pump and/or vessel. Under pressure formed by the flowable outer wall of the pump or vessel, the lubricant can circulate intermittently or continuously, the circulating flow path, and the second fluid connection removes the lubricant that has been inserted into the joint space by the first fluid connection. To recover.

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

The lubricating device can be implanted at various locations on the patient's body, preferably as close as possible to the damaged joint to be lubricated. For example, the lubrication device, or part thereof, may be implanted in the thigh to lubricate the femur ball or knee joint. If the lubrication device, or its container, is relatively bulky, it is desirable to completely fill and implant the container of the lubrication device, since it will be difficult to refill the container in the abdomen. However, in this case, a filling injection port located subcutaneously, connected via a tube to the vessel, may be suitable. Alternatively, the lubrication device may be implanted subcutaneously. Subcutaneous implantation increases the possibility of wireless energy and/or data transfer to or from the lubrication device, if desired. In addition, when the lubrication device is implanted subcutaneously, it is also substantially easy to refill the container by refilling the infusion port with a replenishment needle penetrating through the patient's skin. Depending on the individual treatment, it may be advantageous to implant the lubricating device into the adipose tissue, intramuscularly or near the joint, so that the lubricant can be injected into a particular joint.

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

In one aspect, the implantable medical device is configured to lubricate at least one artificial contact surface that, when implanted into a human or mammalian body, carries a load within the joint, the artificial contact surface, the mammalian contact surface at least two contact surfaces. At one or more of the joints, at least replacing the surface thereof, the medical device further comprises one or more outlets configured to receive lubricant from the container, wherein the medical device, by means of an artificial operating device It is configured to dispense the lubricant from and transport it to the one or more artificial contact surfaces. The implantable medical device may include the container, and 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 that is selected from subcutaneous, or areas consisting of:

a. Abdominal Area,

b. Groin area,

c. Pelvic area,

d. Thigh area.

Thus, the implantable medical device can be placed on the abdomen.

The filling injection port can be implanted subcutaneously, or can be configured to connect with the bone.

The implantable medical device can 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 medial and lateral contact load-carrying surfaces, and the implantable medical device can be configured to lubricate the artificial contact surface on the medial surface of a human or mammalian patient's knee joint.

The mammalian joint has at least two contact surfaces. The medical device is configured to lubricate at least one of the mammalian joint contact surfaces within the joint, at least one artificial contact surface that replaces the surface. In addition, the medical device includes at least one inlet configured to receive lubricant from the container.

Usually, at least partially one or more channels are integrated into 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 operated by an actuating device to dispense lubricant from the container. The possibility of injecting the lubricant intermittently or on demand reduces friction in the joint and also ensures the presence of an appropriate level of lubricant in the joint.

According to one aspect of an implantable medical device, the device may be configured to distribute lubricant to the surface of the artificial contact surface over two or more portions of the artificial contact surface to lubricate the artificial contact surface. Dispensing in more than one place may enable more uniform distribution of lubricant.

According to another aspect of the medical device, the container configured to hold the lubricating fluid may be an implantable container positioned in connection with the body's lumen, subcutaneous, or bone.

The implantable medical device further includes an actuating device configured to transport the lubricant from the container to the artificial contact surface to lubricate the artificial contact surface.

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

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

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

According to one aspect, the implantable medical device may further include a valve configured to bring the connection between the container and the artificial contact surface closer. The container may be configured to be placed in a unit independent from the artificial contact surface, and may be configured to be connected to the artificial contact surface by a conduit. The container can include a movable wall portion configured to move and change the volume of the container, and the wall portion can be an electrically driven wall portion that can include a motor.

According to another aspect, the implantable medical device may include at least one additional channel and at least one inlet port at least partially integrated within the artificial contact surface. The medical device may be configured to allow circulation of lubricating fluid out of the artificial contact surface through the outlet, and into the artificial contact surface through the inlet. Circulation of the lubricating fluid may be performed by an operating device configured to circulate the lubricating fluid. The circulation system may include a container configured to add lubricant to the circulating lubricant, and/or a filter for cleaning the circulating lubricant.

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

An implantable medical device according to one aspect senses physical parameters inside the joint, or volume or pressure of the lubricant, or functional parameters of the actuating device to adjust the actuating device, in order to adjust the flow of the lubricant to the artificial contact surface. It may include a sensor applied to.

The container according to any of the above aspects may be connected to artificial contact surfaces through a conduit. The inlet may include a connection for connecting a conduit to any parts of the medical device. The conduit according to any of the above aspects may include a plurality of parts, which may be configured to be connected to each other through internal connections. The first portion of the conduit can be connected to the medical device, and the second portion of the conduit can be connected to the container. The conduit according to any of the above aspects can be applied to pass through the bones of the body for long-term maintenance of the open passage path through the bone, allowing the lubricant to reach the artificial contact surface. According to another aspect, the conduit can be applied to pass through the joint sac of the body, for long-term maintenance of an open passage path through the articular sac, allowing the lubricant to reach the artificial contact surface, and according to another aspect, the conduit Can be applied to connect into the hip joint through the pelvic bone from the opposite acetabulum.

An implantable medical device can be applied to lubricate the patient's hip joint, wherein the artificial contact surface of the medical device can be configured to at least partially replace the contact surface of the Acetabulum and/or Caput femur. .

An implantable medical device according to one aspect lubricates the second artificial contact surface. According to one aspect, the first artificial contact surface includes a convex structure toward the center of the hip joint, 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 applied to be fixed to the pelvis of the human patient, and the second artificial contact surface is applied to be fixed to the femur of the human patient. The artificial contact surface may be applied to be introduced into the hip joint from the ventral side of the pelvis through the hole in the pelvis, and the surgical method may keep the hip capsule intact.

In one aspect the other container is configured such that the interior or at least a portion of the patient's bone is located therein, which may be, for example, the patient's femur, pelvis, or collum femur.

According to another aspect, the container can be applied to be located within or subcutaneously in the body cavity, wherein the steel can be a steel within an area selected from the region consisting of the abdominal region, groin region, pelvic region, and thigh region. have.

An implantable medical device according to one 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 can be configured to be implanted subcutaneously, connected to the bone, or implanted into the body's cavity.

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

According to another aspect, the implantable medical device is configured to lubricate the patient's knee joint. 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 femur.

According to one aspect, the medical device is applied to lubricate at least one of the medial or lateral portions of the knee bone contact surface, and according to another aspect, the implantable medical device is medial or lateral to the contact surface of the femur of the knee joint. It is applied to lubricate at least one of the parts. According to another aspect, the medical device is applied 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, a container according to any of the above aspects is configured to be recharged from the outside of the human body, and re-release can be performed through an implantable injection port.

According to one aspect, the container is applied to maintain pressure, which may increase pressure through injection of lubricant through the injection port.

According to any of the above aspects, the implantable medical device can be configured as part of a system further comprising at least one switch implantable in a patient to manually and non-surgically control the implantable medical device. . The energized system can 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 can be hydraulically connected to the implantable medical device. The implantable medical device can be configured to be non-surgically controlled by manually pressing the hydraulic container.

According to another aspect, the system may further include a wireless remote controller to non-surgically control the implantable medical device. The wireless remote controller can include at least one external signal transmitter and/or container, and is also implanted inside the patient to receive a signal transmitted by the external signal transmitter or to deliver the signal to an external signal receiver. Possible internal signal receivers and/or transmitters may be further included. The wireless remote controller can also be configured to transmit at least one radio control signal for controlling the implantable medical device. The radio control signal may include a frequency, amplitude, or phase modulated signal, or a combination thereof. The wireless remote controller can also be configured to transmit an electromagnetic carrier wave signal for transmitting the control signal.

According to another aspect, the system may include a wireless energy transfer device for non-surgically supplying energy to implantable energy consuming parts of a medical device implantable by wireless energy. The wireless energy is a sound wave signal, ultrasonic signal, electromagnetic wave signal, infrared signal, visible light signal, ultraviolet signal, laser light signal, microwave signal, radio wave signal, X-ray radiation signal, gamma radiation signal, electric field, magnetic field, combination It may include a wave signal selected from the electrical and magnetic field.

Control signals in the system may include an electric field, a magnetic field, a combined electric and magnetic field. The signal may include an analog signal, a digital signal, or a combination of analog and digital signals. To power the energy consuming parts of the implantable medical device, the implantable system can include an implantable internal energy source. According to another aspect, the system includes an external energy source for transferring energy in a wireless mode, wherein the internal energy source is charged by the energy delivered in the wireless mode.

According to another aspect, the system comprises a measuring device or sensor for measuring or sensing a functional variable associated with the transfer of energy to charge the internal energy source, and a feedback device for transmitting feedback information from inside the patient to the outside of the patient Further, the feedback information may be related to functional variables measured by the measurement device or sensed by the sensor.

According to another aspect, the system further comprises a feedback device for transmitting feedback information from the inside of the patient to the outside of the patient, wherein the feedback information includes one or more of functional variables and physical parameters of the patient related to the implantable medical device. Related.

According to one aspect, the system comprises a sensor and/or measuring device and information related to one or more of a patient's physical variables sensed by the sensor or measured by the measuring device and the sensor sensed or measured by the sensor. In response to functional parameters related to the implantable medical device measured by the device, an implantable internal control unit for controlling the implanted medical device is included. According to one aspect, the physical variable may be pressure or kinetic movement.

According to one aspect, the system can include an external data communicator and an implantable internal data communicator in communication with the external data communicator, wherein the internal communicator supplies the implantable medical device or patient-related data to the external data communicator, And/or the external data communicator supplies data to the internal data communicator.

According to one aspect, the system may further include a motor or pump for operating the implantable medical device, a hydraulic actuator for operating the implantable medical device. The actuating device is a servo designed to reduce the force required for the actuating device to actuate the implantable medical device, rather than performing a longer method in which the actuating device increases the time for a given act. (servo) mechanism.

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

The energy-converting device, as the energy-converting device converts the first form of energy delivered by the energy-transfer device into a second form of energy, the second form to the implantable energy consuming component of the implantable medical device. Power can be supplied directly by the energy of. The second form of energy includes at least one direct current, and regularly vibrates direct current and alternating current. The first and second forms of energy are magnetic energy, kinetic energy, sonic energy, chemical energy, radiation energy, electromagnetic energy, light energy, nuclear energy, thermal energy, non-magnetic energy, non-motion ( one or more of non-kinetic energy, non-chemical energy, non-sonic energy, non-nuclear energy, and non-thermal energy Includes.

To protect the system or part of the system, the system may further include implantable electrical components including a guard of at least 1 volt level and/or a guard of at least 1 constant current. The control device can be configured to control the transfer of wireless energy from the energy-transfer device, and an implantable internal energy receiver for receiving the delivered wireless energy, wherein the internal energy receiver is portable Can be connected to implantable energy consuming parts of the implantable medical device for direct or indirect delivery to the medical device, the system comprising: energy received by the internal energy receiver and implantable energy consumption of the implantable medical device The apparatus may further include a determining device configured to determine an energy balance between the energy used in the parts, the control device based on the energy balance determined by the determining device, the wireless energy from the external energy-transfer device. Can be configured to regulate delivery.

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

The energy-transfer device can include a coil located outside the human body, the coil being connected to supply power to an external coil having an electrical pulse to deliver wireless energy and an implantable energy receiver to be located inside the human body. Further comprising an electrical circuit, the electrical pulse having leading and trailing edges, the electrical circuit having a first time interval between successive leading and leading edges of the electrical pulses and a continuous pulling It is adjusted to change the power of the transmitted wireless energy by changing the second time interval between going and leading edges, and the energy receiver receiving the transmitted wireless energy has changed power. The electrical circuit can be configured to deliver the electrical pulses to remain constant, other than to change the first and/or second time intervals.

According to one aspect, the system has an electric spinner having a time constant configured to change the first and second time intervals that are only within the range of the first time constant, and thus the first and/or second time intervals. When their lengths change, the power delivered to the coils changes.

An implantable internal energy receiver for receiving wireless energy may include an internal first coil, and a first electrical circuit coupled to the first coil and an external energy transfer device for transmitting wireless energy, the energy transfer device A second coil, and a second electrical circuit connected to the second coil, wherein the external second coil of the energy transmitter receives wireless energy received by the first coil of the energy receiver, and the system And a power switch for switching the connection of the internal first coil to the first electrical circuit on and off. Accordingly, feedback information related to charging of the first coil may include: When switching the connection of one coil to the first electrical circuit on and off, it is received by an external energy transmitter in the form of an impedance change under the load of the external second coil.

The system is also an implantable internal energy receiver for receiving wireless energy, an internal energy receiver having an internal first coil, and a first electrical circuit coupled to the first coil, and an external energy transmitter to deliver wireless energy As, it may include an external energy transmitter including an external second coil and a second electrical circuit connected to the second coil, wherein the external second coil of the energy transmitter is the first coil of the energy receiver The wireless energy received by the system, the system further includes a feedback device for communicating the amount of energy received in the first coil as feedback information, wherein the second electrical circuit, the feedback information A determination device for receiving and comparing the amount of energy transmitted by the second coil with feedback information about the amount of energy received at the first coil to obtain a coupling coefficient between the first and second coils Includes.

In an aspect wherein the system includes an outer second coil, the outer second coil may be configured to move relative to the inner 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 applied to obtain feedback information in the determination device 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 includes the following steps: forming an opening reaching the joint from outside the human body, providing an artificial contact surface to the joint, fixing the artificial contact surface to the joint, implanting a container into the human body, and The artificial contact surface is lubricated using a lubricant contained in the container.

The step of lubricating an artificial contact surface or articulation contact surface using a lubricant contained in a container may include implanting an actuating device configured to transport the lubricant from the container to the artificial contact surface. According to another aspect, the step of lubricating the artificial contact surface using a lubricating liquid contained in the container includes providing an energy source for supplying power to the operating device.

According to another aspect, using the lubricant contained in the container may include the step of supplying power to the operating device using the energy source to the artificial contact surface or joint contact surface.

According to one aspect, implanting a container into a human body comprises implanting an actuating device coupled to the container, by using the actuating device to transport the lubricant from the container to the artificial contact surface, The step of lubricating the artificial contact surface is allowed by the lubricant contained in the container.

According to any of the aspects described above, implanting the container includes implanting the container at least partially into the patient's bone, the bone being the patient's femur, the patient's shin bone, and/or It may be the patient's pelvis.

Providing an artificial contact surface may include providing the artificial contact surface from the ventral side of the pelvis.

Implanting the container into the human body may include implanting the container subcutaneously. Positioning the container subcutaneously allows simple access to the container and also eliminates the need for long conduits between the container and the injection port.

Transplanting the container subcutaneously may include implanting the container into one or more of the patient's areas selected from the area consisting of the abdominal area, groin area, pelvic area, thigh area, and calf area.

It is also possible to perform an additional step of implanting the injection port for filling of said container. Implantation of the infusion port may include implanting the infusion 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 patient's joint, the artificial contact surface may include at least one channel for transporting lubricant, and the method includes the following steps: Implanting the medical device in the joint of a human patient, implanting a conduit configured to be connected to the medical device, implanting an actuating device for transporting lubricant into the conduit; Implanting a container to hold the lubricant, and at least postoperatively transporting the lubricant from the vessel to the man-made contact surface by the actuating device, through the channel in the man-made contact surface, thereby transferring the lubrication fluid to the Applying to the artificial contact surface.

Generally, the lubrication device 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 device having an injection needle for intermittent introduction of a lubricant, and a method of implanting a lubricating device having an injection tube for continuous introduction of a lubricant.

In a method for treating osteoarthritis of a human or mammalian joint, e.g., a human hip or knee joint, by providing a lubricant to the joint by means of an implantable lubrication device, an appropriate location including a joint portion of the patient's body by surgery The incision is performed, which may include cutting the patient's skin, in particular, to cut the position where the container is suitable for storing the lubricant. Thereafter, the lubricating device is placed in an appropriately incised position so that the fluid connection portion can introduce the lubricating fluid into the joint postoperatively. For this purpose, a hole is created in the articular bag in the incision open area of the joint, and the injection tube is introduced into the hole to continuously inject the lubricant stored in the container into the joint after surgery. The open ends of the joints are connected continuously. That is, the infusion tube is, first, maintained in a state in which the open end of the infusion tube is permanently in communication with the joint to be lubricated, and secondly, the infusion tube is in contact with the fluid connection device, and thus the hole so as to contact the container Is inserted within. After the positioning of the lubricating device, the patient's body is closed, so that the lubricating device is entirely implanted in the patient's body. This process may be carried out layer by layer, preferably with an operating room or staples, adhesives, or the like. Finally, after the implantation process, lubricating fluid is introduced into the container postoperatively, so that the joint is properly lubricated by operation of the implanted lubricating device.

Alternatively, if the fluid connection includes an injection needle that acts intermittently as an injection member, the appropriate position of the incision opening and positioning of the lubricating device in the joint region, the injection needle is placed in the incision region of the joint. It is realized by placing the drive mechanism of the injection needle close to the injection needle to intermittently introduce and retract the injection needle into and out of the joint, so that the lubricant stored in the container can be intermittently injected into the joint. That is, the injection needle is positioned close to the open area of the joint, allowing it to be intermittently introduced into the joint to lubricate the joint, and then retracted by an appropriate drive mechanism connected to the drive mechanism or the like.

Another method of treating a human or mammalian patient with an implantable lubrication device uses endoscopic or laparoscopic surgery to form the joint region, through which the lubricant can be injected into the joint by an injection member. This region of the joint first expands the cavity at a position close to the joint by inserting a needle or tube-like instrument into the patient's body, and introduces gas through the needle/tube-like instrument to fill the gas within the tissue, , Therefore, the steel is expanded near the joint. Thereafter, at least two laparoscopic/endoscopic trocars are placed in the cavity, and a 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, a suitable position for the rest of the parts of the lubrication device, for example a container, a pump or a motor, is cut open. The lubrication device is then placed in a suitable position, so that the fluidic connection with the injection member is placed in the articular region incised by the laparoscopic so that the lubricant is introduced into the joint. After positioning the lubrication device, the patient body is closed with the effect that the lubrication device is implanted into the patient body as a whole. Thereafter, the lubricating fluid is introduced into the container postoperatively, so that the joint is properly lubricated through the fluid connection device and the injection member.

Also by using laparoscopic method, a lubrication device having an injection tube or an injection needle can be implanted. In the former case, the container is placed in an appropriate position, a hole is formed in the articular sac in the region 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 continuous communication with the joint Once determined, the stored lubricant can be continuously injected into the joint. In the latter case, after positioning the container in an appropriate position, the injection needle and drive mechanism are placed close to the joint area incised by the laparoscope, so that the drive mechanism can introduce the injection needle into the joint (and out of the joint). By being able to (retract), the stored lubricant is intermittently injected into the joint.

Covering the patient's body, or particularly the skin, may include, for example, suturing, taping, and other suitable techniques. The lubrication device can be positioned subcutaneously in the patient's body, or within adipose tissue, or within the muscles. If appropriate, the lubrication device may be placed in or close to the patient's digestive-intestinal or urinary tract. If it is placed near the tubes, it may be fixed to the digestive-intestinal tract or urine tube by a holder connected to a lubrication device. As another alternative, the lubrication device can be placed on the patient's chest or the patient's abdomen. For example, the container can be placed in the abdominal cavity or chest cavity. Alternatively, a portion of it, such as a lubrication device or container, can be implanted by an open surgical procedure, wherein the thoracic cavity or the abdominal wall is opened to position the lubrication device at an appropriate location within the patient's chest or abdomen, The other layers of skin and tissue are then closed by a method such as suture, which is preferably overlapped. Recharging of the container preferably includes injecting a certain amount of lubricating fluid around the container, such as through an injection port integrated and/or connected to the container.

Functional hip movement will be understood as the movement of the hip joint that at least partially corresponds to the natural movement of the hip joint. In some cases, the natural movement of the hip joint may be somewhat limited or altered after hip surgery, which will make the functional hip movement of the hip having an artificial surface somewhat different from the functional hip movement of the natural hip joint. .

The functional position of an implantable medical hip instrument or implant is a position that allows the hip joint to perform a functional hip movement. The final position can be understood as a functional position in which the medical instrument no longer requires a position change.

Functional knee movement should be understood as a movement of the knee that at least partially corresponds to the natural movement of the knee. In some cases, the natural movement of the knee joint may be somewhat limited or altered after knee surgery, which will enable functional knee movement of the knee joint, by an artificial surface somewhat different from the functional knee movement of the natural knee joint. .

The functional position of the implantable medical knee device or implant is a position where the knee joint can perform a functional knee movement.

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

The overall functional size should be understood as the size of the medical knee device when the medical knee device is implanted into the knee joint.

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

A 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 a metal alloy such as cobalt-chromium-molybdenum or titanium or stainless steel, or polyethylene such as crosslinked polyethylene or gas sterilized polyethylene are more reliable. The use of ceramic materials in the entire medical device such as the artificial contact surfaces or zirconium or zirconium dioxide ceramic or alumina ceramic is also reliable. The portion of the medical device that contacts the human bone to secure the medical device to the human bone may be a porous micro or nanostructure applied to promote the growth of the human bone within the medical device for immobilization of the medical device. It may include a Poorhouse structure. The porous structure can be achieved by applying a hydroxy-apatite (HA) coating, or a titanium coating of coarse open pores, which can be produced by air plasma spraying, the titanium coating of coarse open pores and the HA surface layer Combinations comprising are also reliable. The contact portion can be made of a waxy polymer such as PTFE, PEa, FEP, PE or UHMWPE, or a self-lubricating material such as a powder metal-like material into which a lubricant can be injected, which is preferably biocompatible, such as hyaluronic acid derivatives. It is a lubricant. It is also preferred that the material of the surface or contact portion of the medical device according to the invention is configured to be lubricated constantly or intermittently. According to some embodiments, the parts or parts of the medical device are a combination of a metallic material and/or carbon fiber and/or boron, a combination of a metal and plastic material, a combination of a metal and carbon based material, a combination of a carbon and plastic based material , A combination of flowable and hard materials, a combination of elastic and low elastic materials, Korean or acrylic polymers.

It is understood that any aspect or portion of an aspect, and any method or portion of a method can be combined in any manner. All of the embodiments described herein are shown as part of a general description, and can therefore be combined in any way in general terms. In addition, the description herein can be viewed as generally describing both instruments and methods.

The various features of the aspects above can be combined in any way unless such combinations clearly conflict with each other. Aspects 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 a combination or exchange clearly conflicts with the overall functioning of the device.

1 shows the body of a patient with an implanted lubrication device for lubrication of the hip and/or knee joint.
1A and 1B show the hip and knee joints of FIG. 1, respectively, and have an injection member of the implanted lubricating device inserted therein.
1C shows a side view of the knee joint when a medical device is provided.
1D shows a cross-sectional view of a medical device according to one aspect.
1E shows the main parts of the implanted lubrication device.
1F shows a motor-driven implanted lubrication device that establishes a circulating flow path.
2A shows an implanted lubrication device with a drive device and an injection needle.
Figure 2B is a diagrammatically showing a slight modification to the lubrication device of Figure 2A.
2C shows a cross-sectional view of a component aspect of an implanted lubrication device.
2D shows a motor-driven pump unit suitable for use in connection with the embodiment shown in FIG. 1F.
3 shows a medical device according to one aspect including an artificial contact surface.
4 shows a cross-section of a medical device according to one aspect including an artificial contact surface.
5 is a front view of a human patient showing the hip joint.
6 shows a lateral cross-sectional view of a human patient when performing a laparoscopic/arthroscope procedure.
Figure 7 shows the hip joint when a small hole is formed in the pelvis.
8A shows a hip joint portion when a small hole is formed in the pelvis.
8B shows a cross section of the hip joint when a medical device is provided through a hole in the pelvis.
9A shows a cross section of the hip joint when a medical device is provided through a hole in the pelvis.
10 shows a cross-section of a hip joint provided with a medical device connected to an implantable lubrication system.
11A-C show surgical instruments for use in a method of providing a medical device according to any of the aspects described above.
12 shows a cross section of the hip joint with the medical device implanted and connected to the implantable container.
13A shows a lateral cross-section of the hip joint when a hole is formed through the femur.
13B shows a cross section of the hip joint when the 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.
13D shows a container configured to connect to a medical device in more detail.
14 shows the injection of lubricant into the implantable injection port.
15 shows the implantable medical device in the opposite aspect.
16 shows the hip joint portion when the implantable medical device is positioned in the opposite aspect.
17 shows the hip joint portion when the implantable medical device is positioned in the opposite aspect.
18 shows the hip joint portion when the implantable medical device is positioned and connected to the container in the opposite aspect.
20 shows a front view of a knee joint of a human patient provided with a medical device.
21 shows an implantable lubrication system.
22A shows a side view of the knee joint when a medical device is provided in the femur.
22B shows a side view of the knee joint when a medical device is provided to the shin bone.
23 shows a medical device comprising an artificial knee surface.
24 shows a medical device comprising an artificial knee surface.
25A shows a medical device comprising multiple medical device components.
25B shows when a medical device comprising multiple medical device components is assembled.
26 shows a medical device when a medical device including multiple medical device parts is fixed to the shin bone.
FIG. 27 shows the shape of an implantable medical device according to one aspect, secured to the shin bone and connected to a container and infusion port.
28 shows a frontal view of a distant patient provided with an implantable infusion system.
29 shows the implantable lubrication system in more detail.
30 shows the implantable circulating lubrication system in more detail.
31 shows the implantable circulating lubrication system in more detail including a filter.
32 shows the implantable lubrication system when lubricating the hip joint surface.
33A shows a first state of an implantable lubrication system comprising a retractable needle.
33B shows a second state of an implantable lubrication system comprising a retractable needle.
34 shows a system for treating a disease, comprising a device of the invention implanted in a patient.
35-49 schematically show various aspects of a system for wirelessly powering the device shown in FIG.
FIG. 50 is a schematic block diagram showing an appropriate amount of energy supply structure used for the operation of the apparatus shown in FIG. 34.
51 schematically shows an aspect of the system, wherein the device is a device operated with energy delivered by a wire.
FIG. 52 is a block diagram showing in greater detail an arrangement for controlling the delivery of wireless energy used for the operation of the device shown in FIG. 34.
53 is a circuit for the configuration shown in FIG. 52, according to an executable embodiment.
54-60c show various methods of hydraulic or pneumatic energy supply of a device performed in a patient.

Hereinafter, preferred embodiments will be described in detail. In the illustrated figures, similar reference numbers indicate identical or corresponding elements in several figures. It will be understood that these drawings are for illustration only and do not limit the scope of the invention in any way. Accordingly, all references to directions such as “above” or “below” are merely indicative of the directions shown in the figures. In addition, any direction shown in the drawings is for illustrative purposes only.

It should be noted that any method or part of an embodiment, as well as any embodiment or part of an embodiment, may be combined in any way. All examples herein are to be regarded only as part of the general description, and therefore are generally combinable in any way.

FIG. 1 shows the body of a patient implanted with a lubrication device, which consists of a body 1401 and a joint to lubricate the lubricating fluid stored in the reservoir, here two fluid connectors 1402 transporting to the hip and knee joints. will be. Accordingly, the main body 1401 includes a storage unit for storing the lubricant, and may also include additional parts such as a pump, a motor, and a control unit. The lubricating device, ie all of its parts, can be implanted entirely into the patient so that the joints can be adequately smoothed after surgery, independent of any extracorporeal parts or implants that significantly reduce the patient's risk of infection. . Depending on the type of joint and the severity of the joint damage, the joint may be lubricated intermittently/periodically, continuously or as needed, for example, depending on the level of lubricant inside the joint. In general, the main body 1401 of the lubricating device can be implanted subcutaneously for easy access, for example, through a wireless control unit or the like, to recharge the reservoir or to easily set the operation mode or function.

In FIGS. 1A and 1B, the two lubricating fluids shown in FIG. 1 are shown in more detail in the joints, hips and knees, respectively. In FIGS. 1A and 1B, the fluid connection tube 1402 includes an injection member at the distal end, which is inserted into the joint space and finally flows lubricant to the joint. 1A shows an injection needle 1403 that penetrates the 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 connection with a driving mechanism (not described), to intermittently process the lubricant. As another example, in FIG. 1B, the injection member is an injection tube 1404, which 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 soft material that does not interfere with the joint or minimizes interference when performing a predetermined operation. No drive mechanism is required in the injection tube 1404 of FIG. 1B.

In general, there are two basic methods of implanting a lubricating device: the traditional method of placing the injection needle 1403 or the injection tube 1404 in a non-incision area without incising the joint area, and the cavity to the laparoscopy at the joint. There is a laparoscopic method of expanding and placing the injection needle 1403 or the injection tube 1404 into the cavity through a laparoscopic trocar. When the fluid connection pipe 1402 ends at the injection needle 1403 as shown in Fig. 1A, the injection needle 1403 is provided so that the drive mechanism of the needle is in and out of the joint space so that the lubricant stored in the reservoir is intermittently injected. Intermittently, the injection needle 1403 is placed in a manner that can be inserted and removed, placed close to the articular capsule or into a hole in the capsule. As another example, as shown in FIG. 1B, when there is an injection tube 1404 at the end of the fluid connection tube 1402, a permanent hole is inserted into the joint capsule where the tube is continuously disposed so that the lubricant can be continuously injected into the joint. Make.

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 may replace the surface of the lateral condyle, the surface of the medial condyle, or both the surface of the lateral condyle and the medial condyle. 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 storage 1108, and in this embodiment, the inlet is on the posterior side of the shin bone 102 and the posterior side of the femur 102. Each is placed. The reservoir 1108 may be filled by means of an injection port 1107 disposed in a manner in fluid contact with the reservoir 1108 in this embodiment. The reservoir 1108 provides lubricant to the inlets 1104; 1123 through conduits 1106 that provide fluid flow between the medical device and the reservoir 1108. The storage unit, in this embodiment, when the storage unit 1108 is charged through the injection port 1107, the storage unit is under pressure, through the injection port 1108, which further includes a chamber for pressurized gas to be compressed. Can be deployed. The inlets 1104; 1123 transport lubricant to the channel 1105, which is at least partially integrated with the artificial contact surfaces 1101, 1102. In the embodiment of Figure 1, channel 1105 is fully integrated into the medical device. The channel 1105 supplies lubricant onto the artificial contact surfaces 1101, 1102, thereby softening the artificial contact surfaces 1101, 1102 and reducing friction, thereby improving its functionality. The implantable medical device may of course be implantable in the knee joints of other mammals, such as horses.

1D shows an implantable medical device according to one embodiment, in which the medical device can replace a portion of the hip joint. The medical device includes a plurality of channels 1105 capable of lubricating 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. The conduit 1106 is disposed in such a manner that the storage device 1108 located on the stem part of the medical device, which can be fixed to the femur of the human patient, is in fluid communication with the plurality of channels 1105. . Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105. In the storage unit 1108 according to the embodiment of FIG. 1D, a spring is installed with a spring 1109 pushing a movable wall portion in the shape of a piston 1110 to pressurize the lubricant. The storage 1108 can be filled through an injection port 1107 disposed on the side of the medical device. The injection of lubricant through the injection port 1107 squeezes the spring 1109, causing pressure on the lubricant, which pushes the lubricant through the conduit 1106 and again to lubricate the hip joint of the human patient. Push it to the channel 1105. The spring installed in the storage unit 1108 is a storage unit of another type capable of applying pressure to the lubricant, such as a storage unit 1108 including a chamber filled with pressurized gas that is additionally pressurized by injecting a lubricant through an injection port. In addition, in addition, when the elastic property of the elastic storage portion pressurizes the lubricating liquid, it is considered that the storage portion 1108 may be an elastic storage portion.

1E shows the implanted lubrication device and its main parts. The lubrication device of FIG. 1E includes a storage portion (R) for storing lubricant, an injection pipe (1404) with a permanently open end located in the joint space, and a fluid connection pipe (1402) connecting the storage portion (R) to it. It includes. Through the fluid connection pipe 1402 and the injection pipe 1404, a gas chamber 1407 capable of generating the pressure required for the volume expansion to form a pressure suitable to pressurize the lubricant from the storage portion R toward the joint , Is disposed inside the storage unit (R). In addition, since the filling injection port 1406 disposed on the outer wall of the storage unit R is accessible through the patient's skin 1405, the storage unit R is supplied by a syringe through which a lubricant is injected through the patient's skin 1405. To replenish it, the reservoir is implanted subcutaneously. The filling injection port 1406 can thus be made of a suitable membrane, such as a polymeric material, that exhibits self-sealing properties against the penetration of the injection syringe.

1F shows another example of a lubrication device according to the invention. The pump P driven by the motor M has two pipe portions 1402a, which form a sufficient circulating flow passage of the lubricating fluid through the storage portion R and a joint lubricated with the storage portion R. 1402b), which is connected to the circulating fluid connector 1402. Each of the two tube portions 1402a and 1402b includes separate injection pipes 1404a and 1404b inserted into the joint space, and the lubricant stored in the storage portion passes through the injection pipe 1404a through the pipe portion 1402a. The lubricating fluid introduced into the joint space and used at the same time is provided with a filter 1428 disposed inside the flow passage partially defined by the tube portion 1402b through the tube portion 1402b through the injection pipe 1402b. It passes through the filter unit 1428 and returns from the joint to the storage unit. Under the pressure generated by the pump P, the lubricant continues to circulate in the circulating flow passage formed by the fluid connection pipe portions 1402a and 1402b so that at least a portion of the lubricant can be reused even after passing through the joint. However, in order to be able to reuse the lubricating fluid flowing from the joint to the injection tube 1404b, there is a possibility of adding soiling and impurities or other foreign particles that may be added to the lubricating fluid during passage through the joint. In order to ensure the quality and desired effect of the lubricant upon reuse, it is removed with a filtration device (1427). The filtration device 1428 has a filter 1428 disposed in the flow passage so that the entire lubricant passes through the filter. The filtration device 1428 can periodically clean the filter 1428 by removing filtered particles through the filter 1428 and accumulating it in a closed deposition space 1433. As another example, the filtered particles may also be returned back into the patient's body, such as blood vessels.

Although the embodiment shown in FIG. 1F can cover a wide variety of storage types, only the specific storage types are described below. The volume of the reservoir R shown in FIG. 1F is divided into two sections by a membrane 1431. One section is filled with gas, and the other section is filled with lubricant. The filling injection port 1430 allows the injection solution to be filled into the storage unit R using a supply needle through the patient's skin 1405. When the reservoir R is stranded, the gas section is at ambient pressure or more over-pressurized. As the lubricant flows out of the reservoir R during each lubrication cycle, the pressure in the gas section will decrease below ambient pressure, i.e. to a relatively negative value. Depending on the specific type of pump (P), a manual ball valve (1431) to prevent any backflow from the pump (P) to the storage (R) and all backflow from the storage (R) to the fluid connection conduit (1402b) It may be beneficial to provide another manual ball valve 1432 to prevent the.

The motor M is wirelessly controlled by a control unit C 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 to provide galvanic contact through the patient's skin. Preferably, if the control unit (C) is preferably programmable wirelessly or by galvanic contact outside the patient's body, in order to properly adjust the configuration of the control unit according to the demand for fluctuations, the control unit (C) is the motor M Is transplanted with. The control unit C determines not only the time period between injection cycles, but also the amount of lubricant injected into the space during each injection cycle. In addition to or instead of the control unit C, a pressure sensing switch for operating the motor M can be subcutaneously placed.

There are various ways to provide 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. In the embodiment shown in FIG. 1F, the extracorporeal primary energy source E is a first through the patient skin 1405 in an energy conversion device T that converts the first type of energy into a second form, such as electrical energy. Deliver tangible energy. The electric energy is used to charge the capacitor A that 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 wave or sound wave signal. For example, the energy conversion device T shown in FIG. 1F may act as a solar cell, but may also be suitable for a specific type of wavelength signal of the primary energy source E. In addition, the energy conversion device T may be configured to convert temperature changes into electrical energy. Instead of an external primary energy source E, an implantable primary energy source E, such as a capacitor A, may also be used, with a typical long-life battery. Further, by using the energy signal, regardless of whether the energy is transmitted wirelessly or by wire, the control signal of the control unit C can be transmitted through appropriate modularization of the energy signal, whereby the energy signal is digital or 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 detailed view of an implanted lubrication device that includes an injection needle 1403 with a tip end 1408. The tip end 1402 is at its distal end and is provided with a discharge port 1409 for lateral lubricant delivery. The needle 1403 is arranged with a longitudinal displacement inside the open-ended connector 1402 when operated by the drive mechanism D.

The fluid connection pipe 1402 is attached to the implanted pump P. The pump P is shown roughly and can be designed in a number of ways. In FIG. 2A, the storage portion R holding the lubricant to be injected into the joint space of the patient is a part of the pump P. As another example, the storage unit R may be connected to the pump P by being spaced apart, for example, as basically shown in FIG. 2B. However, in FIG. 2A, the movable or flexible wall 1410 of the pump P can be realized as a piston or the like, the wall being injected through the fluid connection tube 1402 in the reservoir R (injection needle ( 1403) may be electrically (or manually) displaced to pump the lubricant intermittently. 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 regular time intervals. The reservoir R, pump P and/or other components of the implanted lubrication device, such as the motor described above, the automatic control for the motor, etc., preferably with the injection needle 1403 and the drive mechanism D Transplanted together. Of course, as other embodiments of the present invention can be further considered, other suitable modifications are possible.

In the lubrication device shown in FIG. 2A, the injection needle (leaning against the force of the spring 1411 of the drive mechanism (D) as the pressure in the reservoir (R) is increased by the operation of the movable/flexible wall (1410) 1403). That is, the tip end 1408 of the injection needle 1403 will be penetrated into the joint space to be lubricated. When the return spring 1411 is fully compressed and the pressure exerted on the lubricant by the movable/flexible wall 1410 further increases, the ball valve 1412 returns the second return which is stronger than the first return spring 1411 The spring 1413 will lean forward. In this way, as long as the pressure is applied at a sufficiently high level, the lubricant will be pumped through the fluid connector 1402, the hole injection needle 1403, and the discharge port 1409 of the needle into the patient's joint space. When the pressure is released, the ball valve 1412 will be closed by return springs 1411 and 1413, and the injection needle 1403 will return to its initial position as shown in Figure 2A. This process will be repeated periodically depending on the condition and type of joint to be lubricated so that intermittent lubrication of individual joints is achieved.

It should be noted that the force acting on the injection needle 1403 to move forward can be calculated as the product of the actual pressure and the cross section of the needle 1403. Since the cross section of a typical injection needle is relatively small, a high pressure will have to be created to penetrate the joint space and overcome the reaction forces of the return springs 1411 and 1413. Therefore, it is advantageous to construct the drive mechanism D so that two strictly separated chambers are made in front and behind the drive mechanism. Thus, if 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 entire cross-section of the drive mechanism D, and thus Will be substantially higher.

This is shown in Figure 2B. The driving mechanism D includes a piston 1414 attached to the injection needle 1403 as shown in FIG. 3. The piston 1414 separates the first chamber 1415a in front of the piston 1414 and the second chamber 1415b behind 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 compressive gas may be filled in the chamber 1415b. In such a case, the return spring 1411 can be omitted, since the compressed gas will already form a needle retraction force.

However, the gas chamber is difficult to seal safely. Accordingly, 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 may be of a simple balloon type that can be filled without forming any strong resistance. As another example, the flexible volume 1416 can 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 may be omitted.

Instead of the flexible volume 1416, a conduit 1417 (which functions as a fluid connector 1402) may connect the second chamber 1415b with the storage R. That is, when the injection needle 1403 is advanced, 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 As it becomes, the fluid will flow back from the reservoir R through the conduit 1417 to the second chamber 1415b. The pump P and the storage unit R are transplanted into the patient's body together with the driving mechanism D and the needle 1403 as a single unit or spaced apart as necessary.

FIG. 2C shows a very small lubrication device, implanted subcutaneously, so that the needle 1403 is intermittently advanced into the joint when actuated by the driving mechanism D, in a position very close to the joint to be lubricated. Each component of the device is housed in an integral body 1418 including outer walls 1419a, 1419b. The volume defined by the outer walls 1419a, 1419b is completely filled with the lubricant. The wall portion 1419a is flexible enough to allow for changes in volume that occur during each injection and refill. The wall portion 1419a is made of a polymer material that is self-sealing against the penetration of the injection needle 1403. The lubrication device can thus be refilled with lubricant through the polymer wall portion 1419a while implanted subcutaneously.

The other wall portion 1419b is sturdy, providing some stability to each component within the body 1418. The window region 1420 is formed of a solid wall portion 1419b, and the penetration film 1421 is pressed into the window region 1420 to be sealed. The penetrating film 1421 is made of a self-sealing material for the penetration caused by the injection needle 1403, and the injection needle is disposed to penetrate the window region 1420 and penetrate into the joint space to be lubricated.

The needle 1403 is connected to the piston 1414 separating the first chamber 1415a in front of the piston 1414 and the second chamber 1415b behind the piston 1414, as described above in FIG. 2B. . A ball valve 1412 with a return spring 1411 and a return spring 1413 is also provided. The opening portion 1422 provides a connection between the second chamber 1415b and the storage portion R, so that when the pressure in the first chamber 1415a rises, the piston 1414 can control the opening through the opening portion 1422. Lubricant can be discharged from the two chambers 1415b to the storage portion R, wherein the storage portion R is generally in an ambient pressure state.

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

The injection device shown in Figure 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 flow path 1423, due to the flow compression portion 1425 in the flow path 1423. The back flow to the storage part R is not performed, and the needle 1403 and the piston 1412 are discharged from the second chamber 1415b through the opening part 1422 to the storage part R while the window area ( 1420). When the piston 1412 is in its distal position and the movable/flexible wall 1410 moves further in the direction of the arrow, the pressure in the first chamber 1415a ultimately spring force of the return spring 1413 It will rise to a level high enough to overcome this, so that the ball valve 1412 opens and the lubricating fluid whilst through the tip 1408 hole needle 1403 through the membrane 1418, the body 1418 of the lubrication device. ) Will be supplied to the properly positioned joint. When the movable/flexible wall 1410 is slid 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 retracted simultaneously. It will re-enter the retracted position. The flow path 1423 is necessary to further move the movable/flexible wall 1410 even after the piston 1412 has reached the starting position, so that additional lubricant is added to the first chamber 1415a in the reservoir R , And additional lubricant compensates for the amount of lubricant delivered to the patient during the intermittent infusion cycle. In addition to the intermittent advancing and retracting capabilities of the drive mechanism D, the drive mechanism of the lubrication device shown in FIG. 2C provides means for moving the tip end 1408 of the injection needle 1403 laterally to prevent fibrosis and the like. It may further include.

The lubrication device shown in FIG. 2C provides several advantages, such as not using any gas chamber and requiring no special sealing of the movable/flexible wall 1410 and piston element 1412. It is preferable that the injection needle 1403 and the return springs 1411 and 1413 are made of an inert metal, but it should be noted that all parts of the injection device shown in Fig. 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 a motor-pump unit is well described in WO 2004/012806 A1, and other pump units described in the above documents can also 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 device 1434 are composed of two main elements of the assembly mounted inside the cylindrical housing 1435. The valve device 1434 is fixedly installed on the housing 1435 and in contact with the first valve member in the form of a fixed ceramic disc 1436, facing the ceramic disc 1436 and rotatable relative to the fixed disc 1436, It includes a second valve member in the form of a ceramic disk (1437). Motor 1438 is mounted on housing 1435 surrounding ceramic disks 1436 and 1437. The motor 1438 is centered lower on the rotatable disk 1437 so that the disk 1417 follows the rotation of the motor 1435 but slightly moves the disk 1417 in the axial direction with respect to the motor axis 1439. And a splined motor shaft coupled with a corresponding spline in the hole. On the motor shaft 1439, a stop member 1440 and a spring washer 1441 exerting a slight pressure against the disc 1431 are installed to force the stop disc 1436 to face.

The pump P includes a pump membrane 1451, which can be any type of membrane. Preferably, the film 1451 is a metal film, such as a titanium film, or is a type of coated plastic material to prevent the diffusion of fluid through the film 1451 over time and to prolong its life. In this embodiment, the actuating device incorporated into the valve pump assembly comprises a cap sleeve 1452 having a cut-out groove with two opposing cam surfaces 1452, It includes a cam wheel (1454) that rotates within the cut-out groove and pushes the cam surface (1453), and a pump shaft (1455) connected to the rotating disk (1437). The cam wheel 1454 is installed on the pump shaft 1455 through the cam wheel shaft 1456. Since the pump shaft 1555 is connected to the rotating disc 1417 through the spline shaft 1601, which is coupled with the corresponding spline in the upper center hole 1601 in the rotatable disc 1417, Rotates. The spline coupling described allows the disk 1417 to move axially relative to the pump axis 1555. The pump shaft 1555 is installed in an encapsulated ball-bearing 1458 and is axially fixed relative to the ball-bearing 1458. Several long grooves 1459 on the pump shaft 1555 extend through the ball-bearing 1458, between the first chamber 1442 of the fixed disk 1436 and the pump chamber 1460 below the membrane 1451 It is provided as a fluid flow path.

When the motor 1438 rotates, the film 1451 moves up and down. As the membrane 1451 moves up and down, the rotatable disk 1417 alternately connects the first channel 1442 with the second and third channels 1444, 1445, so that the fluid is the second channel 1444. Alternatively, the third channel 1445 is delivered to the pump channel 1460 or is supplied from the pump chamber 1456 by the second channel 1444 or the third channel 1445. In FIG. 2D, the first channel 1442 is connected to the second channel via an open channel 1450 such that the second channel 1444 receives fluid from the chamber 1460 through the first channel 1442. It appears to be connected.

The individual materials selected for the discs 1436 and 1437 are very important, as these discs must not be sticking to each other over time and must be able to operate with very precise tolerances. There are several commercially available materials suitable for this purpose, such as ceramics or mixtures of ceramics and other materials such as carbon filters.

3 shows a medical device according to one embodiment, in which the medical device can replace the contact surface of the femur head of the human patient's femur. In the medical device according to this embodiment, the artificial contact surface 1103b of the medical device includes a plurality of channels capable of softening the hip joint of a human patient using a lubricant. In addition, the medical device includes a fixing portion 44 for fixing the medical device to the femoral head and/or the femoral neck of the femur.

FIG. 4 is a medical device including a plurality of channels connected in a manner in fluid communication with a storage part (not described) through a conduit 1106 disposed in the center of the fixing part 44, a channel completely integrated in the medical device ( 1105) is a cross-sectional view of the medical device of FIG. 3. Conduit 1106 transports lubricant to inlet 1123 for additional supply to channel 1105. The end of the conduit is a connecting section 1111, which can connect the conduit to a second conduit 1106 or storage, or an additional channel.

FIG. 5 is a front view of the body of a human patient, illustrating a method of laparoscopic/articular hip joint surgery for providing a medical device according to any embodiment of the present invention in the opposite direction of the acetabulum 8; The hip joint consists of the acetabulum (8) and the femoral head (5). Through a small incision 14 in the abdominal wall of a human patient, laparoscopic/arthroscope trocars 33a, b, c can be inserted into the patient's body. Thereafter, one or more cameras 34, a surgical device 35 capable of making a hole in the pelvic bone 35, or a device for introducing, mounting, connecting, attaching, creating or filling an implantable medical device (36), can be inserted into the body through the laparoscopic / arthroscopic trocar (33a, b, c).

6 is a side view of the body of a human patient showing the hip joint shown in the fragmentary view. The hip joint consists of the femoral bone (6), the upper part of the femur (7), and the femoral head (5) at the top. The femoral head (5) is connected to the acetabulum (8), which is the bowl shape of the pelvic bone (9). Laparoscopic/arthroscope trocar (33a, b, c), introduces, mounts, and connects one or more cameras 34, a surgical device 35 capable of making a hole in the pelvic bone 9, or an implantable medical device, Using the device 36 for attachment, creating or filling, the hip joint 39 is reached.

7 shows dissecting the pelvic bone 9 to make a hole 18 in the pelvic bone 9. The hole 18 is formed from the ventral side of the pelvic bone 9 through repetitive or continuous movement of the hole forming device 22 mounted to the human patient from the ventral 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 hole 18 is large, and allows the implantable medical device to pass through the entire functional size through the hole 18.

FIG. 8A shows a second, where the hole 20 is much smaller, made by a laparoscopic/arthroscope method or a surgical method, as shown in FIG. 8A, where the hole forming device 22 can make the hole 20 smaller. Examples and incisions and dissections performed on the human body are also shown.

8B shows a cross-section of a hip joint provided with a medical device between the femoral head 5 and the acetabulum. The medical device according to this embodiment includes a multi-channel 1105 connected to a conduit 1106, which is connected to a connection disposed in a hole in the pelvic bone 9. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105. For insertion through the hole 18 of the pelvic bone 9, which is smaller than the medical device, the medical device may be rolled up or compressed, or in other embodiments, may be absorbed by the human body, melted, or of the medical device. It can be molded to a position in the mold that can serve as a surface. The medical device can be secured using an adhesive or a mechanical fixation element.

9A shows a hip joint fragment in the case of providing a medical device through a hole 18 in the pelvic bone 9 to replace the contact surface of the femoral head 5. The medical device is located in the center of the medical device and includes a fixing part 44 that can fix the medical device to the femoral head 5 and an artificial contact surface 1103b. The medical device includes a plurality of channels 1105 present on an artificial contact surface for softening the hip joint. The channel is in fluid connection with conduit 1106, which is connected to an interconnect 1111b that connects the conduit to a second conduit 1106b or a second portion of conduit 1106b. In fluid communication with the storage 1108 located in the femur 7 of the human patient. The reservoir 1108 is located in the femur 7 and can hold the pressurized lubricant, and in the embodiment shown in FIG. 9A, the pressurized lubricant is a movable wall portion in the form of a piston 1110, which pressurizes the lubricant It is pressurized using the storage unit 1108, which is a spring installed by the spring 1109 combined with the. The reservoir 1108 is also connected to an injection port 1107 located in combination with the femur 7 at a much lower portion in the former (trochanter 1186), but any other suitable placement, combination in the bone, cavity, or subcutaneous Placement is also possible. The medical device is operable using a pressurized reservoir according to the embodiment of FIG. 9A, and in other embodiments, is capable of being moved by a direct propulsion such as induction or self-propelled or by an accumulated energy source such as a battery. , Can be operated by a powered operating device, such as an implantable pump. A channel or conduit (not shown) according to one embodiment includes a valve that closes the flow of lubricant through the conduit 1106 or channel 1105 to close the connection between the reservoir and the artificial contact surface. The valve may be operated and controlled outside the human body using, for example, a remote control.

9B shows a cross section of a hip joint in which a medical device according to another embodiment is provided on the hip joint and replacing the contact surface of the femoral head. The medical device includes an artificial contact surface 1103b that includes a plurality of channels 1105 connected to conduits 1106 and 1106b located on a 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, whereby the reservoir is in fluid with channels of the medical device for lubricating the artificial contact surface 1103b of the medical device. Exchange.

10 shows a hip fragment provided with an implantable medical device that can replace the acetabular contact surface. The medical device includes an artificial acetabular surface 65 that includes a plurality of channels that are connected to the conduit 1106 by an 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. In addition, FIG. 10 shows a unit connected to a conduit, in one embodiment, the unit 1108 and a plurality of channels 1105 for lubricating the implantable medical device through the conduit 1106 and additionally. ), two pressure forming devices 1113a and 1113b capable of forming a pressure for pressurizing the lubricant for pushing the lubricant. Conduit 1106 also transports lubricant to inlet 1123 for distribution to channel 1105. The pressure forming device may be composed of an installed spring or an element filled with pressurized gas, which is further pressurized by injecting a lubricant into the reservoir 1108. The unit further comprises an injection port 1107 comprising a self-sealing membrane 1112, preferably a parylene coated silicone film. In another embodiment, the unit comprises a power-operated device, such as a pump housed in a container 1113a, for pumping lubricant from storage 1108 through conduit 1106 to a plurality of channels 1105. Includes. In one embodiment, the pump is powered through a battery housed in compartment 1113b.

11A shows 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 FIGS. 11A, B and C, the instrument further comprises a rotating element 78 capable of rotating the gripping portion 76 according to the handling portion 77, but this rotating element 78 is provided in the surgical instrument. ) Is also considered equal.

11B shows a surgical instrument capable of inserting a prosthesis, an artificial organ part or parts needed to form or provide a hip joint surface, according to a second embodiment. In this embodiment, the surgical instrument further comprises a parallelly positioned section 79 that facilitates and facilitates the arrival of the instrument from the opposite acetabular cavity through the hole of the pelvic bone.

11C shows a surgical instrument capable of inserting an artificial organ, an artificial organ part or parts necessary to form or provide a hip joint surface as a third embodiment. In this embodiment, the surgical instrument further comprises two angle adjusting members 80a, b. The angle adjustment member can control the angle change of the gripping portion 76 according to the handling portion 77, or from an opposite side of the acetabulum 8 to a suitable angle that can be operated in the hip joint through the hole of the pelvic bone Can be fixed.

12 shows a hip joint cross-section provided with a medical device. The implantable medical device is configured to replace the acetabular surface and be inserted into the hole 18 of the pelvic bone 9, but in other embodiments, the medical device is also configured to be inserted into the hole of the femur 7 or hip capsule. You can consider the same. The medical device includes a plurality of channels 1105 that are interconnected via conduit 1106, and the channels 1105 are arranged in a fluid-flowing manner. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105. Conduit 1106 is also connected to a first portion of interconnect 1111, configured to be connected to a second portion of interconnect 1111b. Since the interconnect 1111 connects the first portion of the conduit 1106 with the second portion of the conduit 1106, the first portion of the conduit 1106 is inserted from the aspherical side of the pelvic bone 9 and the conduit 1106 It is possible to insert the second part of) from the pelvic bone side or the acetabular side opposite to the pelvic bone 9. Connecting the two parts of the conduit 1106 inserts the medical device into the femur 7 or the hole 18 of the hip joint, implants the reservoir 1108 into the abdomen of the human patient, or the pelvic bone 9 It is especially beneficial when transplanted to other parts of the abdomen. Next, the conduit 1106 is connected to the storage unit 1108, and can transport the lubricant from the storage unit 1108 to the hip joint region. The storage 1108 is, in the embodiment shown in FIG. 12, a spring that exerts a force on a movable wall portion in the form of a piston 1110 that applies pressure to the lubricant through the conduit 1106 and also through the channel 1105. By using (1109), pressure can be applied to the lubricant. The reservoir 1108 also includes an injection port 1107 disposed at the top of the reservoir 1108 to fill the reservoir 1108 and at the same time increase the pressure of the lubricant.

13A is a side view of a human patient showing a hip cross section. The femur 7 has a proximal portion composed of the femoral bone 6 and a recent portion composed of the femoral head 5. In FIG. 13A, a hole 82 is made from an incision applied to the femur, and the hole extends to the femur 7 and femoral bone 6, exiting through the femoral head 5 and entering the hip joint. The hole is preferably used to provide a medical device that can be rolled or bent for insertion into the hole 82 in the hip joint.

13B shows a cross-section of the hip, with a medical device provided in the hole 82 of the femur 7 and secured to the acetabular ball 8. The medical device includes a plurality of channels 1105 connecting each other by conduits 1106. In other embodiments, the medical device may be provided in a hip capsule or a hole in the pelvic bone 9. After mounting the medical instrument, using a tool 1180 housing the reservoir 1108 connected to the conduit 1106, the reservoir 1108 is provided in the hole 82 of the femur 7, which is medical Connect to the device's conduit 1106.

13C shows a hip joint cross-section when the storage 1108 disposed in the hole 82 of the femur 7 is connected to a medical device. Conduit 1106 also extends from reservoir 1108 to injection port 1107 to recharge or apply pressure to reservoir 1108.

13D is a detailed view of the storage unit, the storage unit is an interconnect 111 disposed at the distal end of the storage unit, in one embodiment of FIG. 13D, the movable wall portion 1110 in the form of a piston 1110 It includes a pressurized storage unit 1108, which is pressurized by using the spring 1109 pushing the. The storage unit further includes a conduit 1106 connected to the storage and the injection port 1107 to fill and/or pressurize the storage 1108 containing the lubricant. The injection port 1107 includes a self-sealing membrane, which may be a self-sealing parylene coated silicone film to inhibit cell migration on the surface of the injection port. Sections A-A show conduits 1106 disposed in the center of the reservoir 1108 to charge and/or pressurize the reservoir 1108.

14 is a cross-sectional side view of a human patient showing injection into the injection port 1107 for injecting the lubricant by the injection member 92 including a container 1115 capable of containing the lubricant to be injected. The injection port is connected to the implantable medical device disposed in the hip through a conduit 1106 that can provide fluid flow between the injection port and the medical device. Next, the medical device includes a plurality of channels 1105 for lubricating the artificial contact surface, lubricating the hip joint. In the embodiment shown in Fig. 14, the medical device is provided from the ventral side of the pelvic bone 9 through a hole made in the pelvic bone, and then the removed bone plug is reinserted, sealed and fixed with a screwed mechanical fixation part. do. In another embodiment, the medical device is provided through the hip capsule 12 or femur 7 from the hip joint side of the pelvic bone 9, and then through the interconnect 1111, the abdomen of the pelvic bone 9 On the side it is connected to the conduit 1106. As such, the infusion port 1107 can be placed in the abdomen, subcutaneous, intracavity 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 direction of the hip joint. The first artificial contact surface 112 may be fixed to the pelvic bone 9 of the human patient. The artificial convex hip joint surface 112 may be fixed to the pelvic bone 9 and may be inserted through the hole 18 of the pelvic bone 9. The medical device includes a nut 120 that includes a thread for securing the medical device securely to the pelvic bone 9. The medical device also includes an artificial organ part 118 designed to occupy a hole 18 made in the pelvic bone 9 after the medical device is implanted into the patient. The artificial organ part 118 includes a support member 119 designed to contact the pelvic bone 9 and assists in distributing the load on the medical device from the weight of the human patient in normal use. Normal use is defined as being the same as using a human hip joint. In addition, the medical device includes a locking device 116 that includes a surface 117 designed to contact the artificial hip convex surface 112. The locking device 1160 additionally includes a securing member 115 designed to assist in securing the locking device 116 to the femoral head 5 or the femoral neck 6 and again to secure the artificial hip convex surface 112. do. The artificial hip convex surface 112 is secured to an attachment rod 113 that includes a thread 114 corresponding to the thread of the nut 120 associated with the artificial tracheal portion 118. The medical device includes a plurality of channels 1105 designed to lubricate the artificial contact surface 112. The plurality of channels 1105 is designed to transport the lubricating fluid from the reservoir to 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, Through conduits 1106, they are connected to each other.

FIG. 16 is the medical device according to FIG. 15 showing when the medical device is placed inside the hip joint. The first artificial contact surface 112 including a convex shape toward the center of the hip joint is disposed inside the second artificial contact surface 109 including a 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 artificial contact surface 112, and the femoral head 5 and femoral bone 6 of the femur ). The medical device includes a plurality of channels 1105 connected to a conduit 1106 disposed in the center of the medical device to provide a lubricant to the medical device to lubricate the artificial contact surface 112 and thus lubricate the hip joint.

17 shows the mounting of the artificial trachea part 118 in the hole 18 of the pelvic bone 9. The artificial organ portion 118 includes a support member 119 designed to contact the pelvic bone 9 and assists in distributing the load on the medical device from the weight of the human patient during normal use.

FIG. 18 shows, as another embodiment, a portion of a medical device including a convex artificial hip joint surface disposed on the femoral head 5 and the femoral neck 6 is located in the porous tissue of the medical device and the femoral neck 6 It shows a medical device, including a plurality of lubrication channels (1105) connected to the conduit (1106b) to establish a fluid flow between the storage. The storage portion, in the embodiment of FIG. 18, can be filled through an injection port, disposed in connection with the femur 7 and positioned significantly below the former 1188. The storage unit and its functions are described in more detail with reference to FIGS. 9A and 9B. 18 also shows the artificial organ part 118 when fixed to the pelvic bone 9 using a screw 121. The screw can be assisted by an adhesive that can be applied at the surface S between the artificial organ part and the pelvic bone 9 or in connection with the screw, or can be replaced with an adhesive.

19 shows the right leg of a human patient. Femoral bone 102 having a distal portion that includes an area between the lateral articular ridge 105, the medial articular ridge 106, and the outer and medial articular ridges. The cross section of the distal portion of the femur 102 includes the contact surface of the knee joint. In addition, the knee joint, which connects the femur 102 with a joint and covers the knee joint to protect it, includes a triangular bone, a patellar bone 101. The knee joint also includes the meniscus (minisci 107, 108), a cartilage component inside the knee joint that serves as an articulating surface to protect the ends of the bone from rubbing against each other. The meniscus (107, 108) also acts as a shock absorber in the knee joint, absorbing the shock generated by the movement of the human patient. Each knee has two meniscus (107, 108), medial meniscus 107 and lateral meniscus 108. In patients with osteoarthritis, the meniscus (107, 108), which acts as an articulating surface, that is, as a weight carrying surface, is worn out, and in severe cases, the bone may be exposed to the joint. The knee joint is also protected by a knee joint capsule or capsular ligament, also known as the articular capsule of the knee joint. The knee capsule is broad and loose, the front and sides are thin, and the bursae, a small vesicle containing the patella (101), ligaments, meniscus (107, 108), and white fibrous tissue. Includes. The knee capsule consists of a synovial membrane and a fibrous membrane, which is separated by lipid accumulation in the anterior and posterior layers.

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

21 shows a front view of the body of a human patient with the storage unit 127 implanted subcutaneously in the abdomen of the human patient. The storage unit according to the present embodiment, the pump 130, which is powered by a battery for pumping fluid from the storage unit 129 through the conduit to the channel 125 to supply lubricant to the artificial contact surface of the knee joint, Type of operating device. The storage unit penetrates the muscle or fascia tissue 1181, which is clamping between the storage unit and the injection port 1107 disposed outside the muscle or fascia tissue 1181, so that the muscle or fascia tissue of the abdominal wall ( 1181).

22A illustrates one embodiment for a case where the medical device includes an artificial knee 115 surface, which clamps the medial, lateral or medial and lateral joint ridge 106 of the knee, which is the distal portion of the femur 7. Show. The medical device according to the present embodiment includes a plurality of channels 1105 for lubricating an artificial contact surface, and the plural channels are in fluid communication with each other through a conduit 1106, and the lubricant included in the storage 1108 It is in fluid communication with the reservoir 1108, which includes an injection port 1107 for applying pressure to or recharging the reservoir. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105.

22B shows a side view of the knee joint, provided with a proximal portion of the tibia 104 that constitutes the lower portion of the leg with the fibula 103, with a medical device comprising an artificial contact surface 1102. 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 at the rear of the tibia 104 and fixed to the tibia 104 according to the embodiment of FIG. 22B, and injects lubricant into the storage unit 1108 and/or enters the storage unit 1108 It includes an injection port (1107) for applying pressure to the lubricant. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105.

23 is a detailed view of a medical device for knee joint transplantation. 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 with a conduit 1106 for transporting lubricant along the artificial contact surface 1101 of the medical device. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105.

24 is a side cross-sectional view of a medical device showing that the channels 1105 are fully integrated and connected to the artificial contact surface, the conduit 1106 lubricates the channels 1105 to lubricate the artificial contact surfaces of the medical device. To supply. Conduit 1106 transports lubricant to inlet 1123 for further distribution to channel 1105.

FIG. 25 shows a medical device for implanting a knee joint in a human patient, wherein the medical device is a mechanical fixation element 120 that provides for the formation of a fitting between a plurality of medical device parts 119 and one base part 118. Thereby, it includes several medical device parts 119, which can be connected to the medical device base part 118, and the parts can also be connected to each other. The medical device base part 118 also includes a fixture 117 that can mechanically secure 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 joint.

25B shows a case in which the medical device of FIG. 25A is assembled.

26 shows the case where the medical device according to FIGS. 25A and 25B is secured to the tibia 104.

27 shows the proximal portion of the tibia, with a medical device comprising an artificial contact surface 1160 secured to the tibia 104. The channel 1105 of the artificial contact surface provides fluid flow between the channel 1105 of the medical device and the first and second reservoirs 1108 disposed inside the tibia 1104 from the inside and outside, The conduit 1106 also connects the first and second reservoirs with an injection port 1107 disposed inside the pelvis to recharge and/or pressurize the reservoir 1108. In the embodiment shown in FIG. 27, the reservoir 1108 is designed to press the lubricant, and thus push 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 the lubricant.

28 shows a front view of a human patient with implantable lubrication system 120 implanted. The implantable lubrication system 120 may continuously or intermittently inject the lubricant into the hip joint as needed. In the embodiment shown in FIG. 61, the implantable lubrication system includes two interconnected units 121 and 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 detailed 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 capable of pumping lubricant from the reservoir 1108 to the hip joint region. The first unit 121 also includes an injection port 1107 for filling the storage unit 1108 outside the human body without performing a surgical procedure. Injection port 1107 includes a self-sealing membrane capable of penetrating a needle attached to a syringe. The first unit 121 further includes a wireless energy receiver 124, preferably comprising 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, and then a battery 126 and a fluid reservoir 1108. The lubricating fluid 128, in the storage unit 1108, passes through the first unit 121 using the pumping device, passes through the conduit 1106, is pumped to the region of the hip joint, or the artificial contact surface of the implantable medical device, or Helps lubricate the hip joint surface. The lubricant is preferably a biocompatible lubricant such as hyaluronic acid.

30 uses any medical device described herein, according to an embodiment wherein the implantable lubrication system is a circulating lubrication system that includes one inlet 130 and one outlet 131 into the joint to be lubricated. Shows a possible, implantable lubrication system. Preferably, the system is a continuous lubrication system in which the pumping member 123 continuously circulates the lubricant 128 inside the hip joint.

31 shows an implantable lubrication system for circulatory lubrication, which may utilize any medical device described herein, the lubrication system further comprising a filter member 132 for filtering the lubricant. The filter can be self-cleaning, and out filtered matter is assigned through a disposal channel 133 into the abdomen of a human patient or a container attached to the removal channel 133. Through filtration of the lubricant 128, the circulating lubrication system can operate for a long period of time without any surgical procedures.

FIG. 32 shows that the lubricant of FIG. 29 is lubricated by providing lubricant 128 to an implantable medical device that includes an artificial contact surface 45.

33A is any described herein, according to another embodiment, wherein the lubrication system includes a unit 1310 that includes a retractable needle 1311 secured to an operating system for operating the retractable needle 1311. Shows a lubrication system that can be used in combination with medical devices. The needle may pass through a self-sealing membrane 1314 disposed in the pelvic bone 9 to inject lubricant into the joint. The conduit 1106 can supply the unit 1310 from an infusion port and/or additional storage that can be lubricated subcutaneously or implanted into the body's cavity.

33B shows the lubrication system, with the retractable needle 1311 placed in a position advanced by an operating device with an operated retractable needle 1311. The needle passes through the self-sealing film 1314 and is positioned at a position where lubricating fluid can be injected.

34 exemplarily shows a system for treating a disease including a device 10 of the present invention (hereinafter referred to as an implant device 10) disposed on a patient's abdomen. The implanted energy conversion device 1002 may supply energy to the energy consuming parts of the device through the power supply line 1003. An external energy transfer device 1004 for non-invasively supplying energy to the implantation device 10 transfers energy by one or more wireless energy signals. The implanted energy conversion device 1002 converts energy from a wireless energy signal into electrical energy supplied through the power supply line 1003.

The implanted energy conversion device 1002 may also include other components, such as coils for receiving and/or transmitting signals and energy, antennas for receiving and/or transmitting signals, microcontrollers, and charge control units. Optionally, to control the operation of motors, pumps, and medical implants, including one or more sensors, transceivers, and optionally motor controllers, such as capacitors, energy sensors, temperature sensors, eye sensors, position sensors, motion sensors, etc. Other parts may be included.

The wireless energy signal may include a wavelength signal selected from the following: sound wave signal, ultrasonic signal, electromagnetic wave signal, infrared signal, visible light signal, ultraviolet signal, laser beam signal, microwave signal, radio wave signal, x-ray emission Signal and gamma radiation signal. As another example, the wireless energy signal may include an electric field, a magnetic field, or a combination of an electric field and a magnetic field.

The wireless energy transfer device 1004 may transmit a carrier signal for sending a wireless energy signal. Such a carrier signal 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, an energy conversion device 1002 is provided to convert the first type of wireless energy delivered by the energy transfer device 1004 to 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 first type of energy delivered by the energy transmission device 1004 to the second type of energy, the energy conversion device 1002 directly provides the device with a second type of energy. can do. The system may additionally include an implantable capacitor, wherein the second type of energy is used at least partially for charging the capacitor.

As another example, since the wireless energy delivered by the energy transmission device 1004 is transmitted by the energy transmission device 1004, it can be used for directly providing power to the device. When the system includes an actuating device for actuating the device as described below, kinetic energy for actuating the device is provided by directly powering the actuating device using wireless energy delivered by the energy conversion device 1004 Can cause

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

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 It is preferred that the other of them is non-magnetic, non-motility, non-chemical, non-acoustic, non-nuclear or non-thermal.

The energy transfer device may be controlled from outside of the patient's body to emit electromagnetic wireless energy, and the implanted device may be operated using the emitted electromagnetic wireless energy. Alternatively, the energy transfer device may be controlled outside the patient's body to emit non-magnetic radio energy, and the device may be operated using the emitted non-magnetic radio energy.

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

The radio control signal can be a frequency, amplitude or phase modulated signal, or a combination thereof. Alternatively, the radio control signal can be an analog signal, a digital signal, or a combination thereof. The radio control signal may include 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. The carrier signal may include a digital signal, an analog signal, or a combination thereof. When the control signal includes an analog signal, a digital signal, or a combination thereof, the wireless remote control unit may transmit an electromagnetic carrier signal for carrying the digital control signal or the analog control signal.

35 is an energy conversion device 1002 for supplying power to the implantation device 10 of the present invention through the implantation device 10 of the present invention, a power line 1003, and energy installed externally. 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 drawing, with the right side being inside the patient's body and the left side outside the patient's body based on the vertical line.

FIG. 36 is an embodiment similar to FIG. 35, in the embodiment of FIG. 36, a device for reversing in the form of an electrical switch 1006 that can be operated with polarized energy to reverse the implantation device 10 of the present invention ( The difference is that the reversing device is implanted in the patient's body. When the electric switch is operated by polarization energy, the wireless remote control unit of the external energy transfer device 1004 transmits the polarization energy on a wireless signal, and the implanted energy conversion device 1002 converts the wireless polarization energy into polarization current. Switch to operate the electrical switch 1006. When the polarity of the current is changed by the implanted energy conversion device 1002, the electrical switch 1006 reverses the function performed by the implantation device 10 of the present invention.

FIG. 37 is an embodiment similar to FIG. 35, in the embodiment of FIG. 37, an operation device 1007 for implanting a patient's body to operate the implant device 10 of the present invention includes an energy conversion device 1002 There is a difference in that it is installed between the implant devices 10 of the present invention. This operating device can be a motor 1007 such as an electric servomotor. The motor 1007 receives energy from the energy conversion device 1002 as the remote control unit of the energy transmission device 1004 transmits a wireless signal to the reception unit of the energy conversion device 1002.

38 is an embodiment similar to FIG. 35, in the embodiment of FIG. 38, an operating device in the form of an assembly 1008 including a motor/pump unit 1009 and a fluid reservoir 1010 is implanted in a patient There is a difference in that there is. In this case, the implantation device 10 of the present invention operates hydraulically. That is, the hydraulic fluid is pumped by the motor/pump unit 1009 from the fluid storage unit 1010 through the conduit 1011 to the implantation device 10 of the present invention to operate the device of the present invention. The hydraulic fluid is pumped by the motor/pump unit 1009 from the implantation device 10 of the present invention to the fluid reservoir 1010 to restore the device of the present invention to the starting position. The energy conversion device 1002 converts wireless energy into a current such as a polarization current, and supplies power to the motor/pump unit 1009 through the power line 1012.

It is contemplated that, instead of the hydraulically actuated implantation device 10, the actuating device is also possible. In this case, the hydraulic fluid can be compressed air used for regulation, replacing the fluid reservoir with an air chamber.

In these embodiments, the energy conversion device 1002 may include a rechargeable capacitor, such as a capacitor or battery, that is charged by wireless energy and supplies energy to any energy-using parts of the system.

Alternatively, the wireless remote control described above can be replaced by a manual control of any implanted portion, such as a push button located beneath the patient's skin, which allows the patient to make most of the indirect contact with the hand.

39 shows an embodiment of the present invention comprising an external energy transfer device 1004 with a wireless remote control, in this example a hydraulically operated implantation device 10, and an implanted energy conversion device 1002. An embodiment of the present invention further comprises a device for reversing 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 into the patient's body It is. Since the hydraulic operation can be easily performed by simply changing the pumping direction, there is no need to have a hydraulic valve. The remote control unit may be a device separated from an external energy transfer device or a device included in the energy transfer device. The motor of the motor/pump unit 1009 is an electric motor. The implanted energy conversion device 1002 supplies the energy transmitted by the control signal to the motor/pump unit 1009 in response to a control signal provided from the wireless remote control unit of the external energy transfer device 1004, The motor/pump unit 1009 distributes hydraulic fluid to the hydraulic fluid reservoir 1013 and the implantation device 10. The remote control unit of the external energy transfer device 1004 controls the hydraulic valve switching device 1014 so that the fluid is pumped from the hydraulic fluid storage unit 1013 to the implantation device 10 by the motor/pump unit 1009. The direction of hydraulic fluid flow between the direction and the direction in which the fluid is pumped from the implantation device 10 to the hydraulic fluid storage portion 1013 by the motor/pump unit 1009 to return the implantation device 10 to the starting position. Try to switch.

40 is an implanted internal control controlled by an external energy transfer device 1004 having a wireless remote control unit, a transplantation device 10, an implanted energy conversion device 1002, and a wireless remote control unit of the external energy transfer device 1004. An embodiment of the invention is shown that includes a unit 1015, an implanted capacitor 1016, and an implanted capacitor 1017. The internal control unit 1015 stores electrical energy received from the implanted energy conversion device 1002 in the capacitor 1016, and supplies the energy to the implantation device 10. The internal control unit 1015 causes electric energy to be released from the capacitor 1016 in response to a control signal provided from the wireless remote control unit of the external energy transfer device 1004, and supplies the released energy to the power line 1018, 1019), or by transferring the electrical energy directly from the implanted energy conversion device 1002 through a power line 1020, a capacitor 1017, a power line 1021, and a power line 1019, the implantation device ( 10) is activated. Capacitor 1017 stabilizes the current.

Preferably, the internal control unit can be programmed 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 input from any sensor sensing a patient's physical parameter 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 without the capacitor 1016 of the present embodiment is also possible.

FIG. 41 is an embodiment similar to FIG. 35, in which the embodiment of FIG. 41 includes a battery 1022 that supplies energy to operate the implantation device 10 and an electrical switch 1023 that switches the operation of the implantation device 10. The difference is that it is implanted in the patient's body. The electric switch 1023 may be controlled by a remote control unit, and an off mode in which the battery 1022 is not used by the energy supplied by the implanted energy conversion device 1002 and operation of the device may be performed. To that end, the battery 1022 may be configured to switch between on modes to supply energy.

42 is an embodiment similar to FIG. 41, the embodiment of FIG. 42 differs in that the internal control unit 1015 controllable by the wireless remote control of the external energy transfer device 1004 is implanted in the patient's body. . In this example, the electrical switch 1023 prevents the wireless remote control unit from controlling the internal control unit 1015, the off mode in which the battery is not used, and the wireless remote control unit controls the internal control unit 1015 to implant the device. It is operated by the energy supplied by the implanted energy conversion device 1002, to enable switching between standby modes that allow energy to operate 10 to be released from the battery 1022.

FIG. 43 is an embodiment similar to FIG. 42, in which the embodiment of FIG. 43 replaces the battery 1022 with a capacitor 1016 and the implanted elements are connected differently. In this example, capacitor 1016 stores energy provided from implanted energy conversion device 1002. The internal control unit 1015 has an off mode in which the capacitor 1016 is not used and a capacitor 1016 is implanted in response to a control signal provided from a wireless remote control unit of the external energy transfer device 1004. The electrical switch 1023 is controlled to switch between on-modes that supply energy for operation. The capacitor may be combined with a capacitor or replaced with a capacitor.

FIG. 44 is an embodiment similar to FIG. 43. The embodiment of FIG. 44 differs in that the battery 1022 is implanted in the patient's body and the implanted parts are connected differently. The internal control unit 1015 responds to a control signal provided from the wireless remote control unit of the external energy transfer device 1004, in which the off-mode battery 1022 is not used and the battery 1022 connects the implant device 10. To switch between on modes that supply electrical energy for operation, the capacitor 1016 is controlled to deliver energy for operating the electrical switch 1023.

Alternatively, the electrical switch 1023 is operated by the energy supplied by the capacitor 1016, so that the wireless remote control unit can control the battery 1022 so that it does not supply electrical energy, and the wireless remote control unit is implanted. It is possible to switch between standby modes that control the battery 1022 to supply electrical energy for the operation of the device 10.

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

FIG. 45 is similar to FIG. 41, but the motor 1007, a mechanical reversing device in the form of a gear box 1024, and an internal control unit 1015 controlling the gear box 1024 are implanted in the patient's body. The dots represent different examples. The internal control unit 1015 controls the gear box 1024 to reverse the function (mechanically operated) performed by the implantation device 10. The gear box of this example may represent a servo device that saves force so that the actuating device operates in a long stroke.

Figure 46 is similar to Figure 52, but shows an embodiment in which the implanted elements are connected differently. Thus, in this example, the internal control unit 1015 is powered by the battery 1022 in case the capacitor 1016, preferably a capacitor, causes the electrical switch 1023 to switch to the on mode. When the electrical switch 1023 is in the on mode, the internal control unit 1015 controls the battery 1022 to supply or not supply energy to operate the implantation device 10.

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

To sense the patient's physical parameters, a feedback device comprising a sensor or measurement device 1025 can be implanted into the patient's body. Physical parameters may be selected from the group including pressure, volume, diameter, extension, elongation, expansion, movement, flexion, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heart rate, breathing, and the like. The sensor can detect any of these physical parameters. For example, the sensor can be a pressure sensor or a motion sensor. Alternatively, the sensor 1025 can be configured to detect functional parameters. Functional parameters may be related to energy transfer to alter the implanted energy source, including electrical, any electrical parameters, pressure, volume, diameter, extension, elongation, expansion, movement, warpage, elasticity, temperature and flow. It can be selected from the group.

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

The wireless remote control unit of the internal control unit 1015 or the external energy transfer device 1004 may control the implantation device 10 according to a signal from the sensor 1025. The transmitter/receiver may be combined with the sensor 1025 to send information on the detected physical parameter to an external wireless remote controller. 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 reception unit or a signal transmission/reception unit, and the internal control unit 1015 may include a signal transmission unit or a signal transmission/reception unit. Such a transmitting/receiving unit, a transmitting unit and a receiving unit may be used to transmit information or data related to the implant device 10 outside the patient's body.

When the battery 1022 that supplies power to the motor/pump unit 1009 and the motor/pump unit 1009 is implanted, information related to charging of the battery 1022 may be fed back. More precisely, when the battery or capacitor is charged according to energy feedback information related to 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 implantation device 10 via a subcutaneous electrical switch 1026. Thus, control of the implantation device 10 is achieved non-invasively by manually pressing the subcutaneous switch. The operation of the implantation device 10 is on and off. The illustrated embodiment is simply shown, and it is possible to add additional elements to the system, such as an internal control unit or any other component disclosed herein. Two subcutaneous switches may be used. In a preferred embodiment, one implanted switch transmits information to the internal control unit to perform a predetermined predetermined operation, and when the patient presses the switch once more, the operation may be reversed.

49 is another embodiment, the system 1000 of this embodiment includes a hydraulic fluid reservoir 1013 hydraulically connected to the device. 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 association with an injection port for injection of hydraulic fluid, preferably calibration of hydraulic fluid.

The system can include an external data communicator and an implantable internal data communicator. The implantable internal data communicator can communicate with an 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 provides data to the internal data communicator.

FIG. 50 relates to one or more functional parameters of a device or system, or to physical parameters of a patient, to provide an accurate amount of energy to the implanted internal energy receiver 1002 connected to the implanted energy use element of the implantation device 10. It schematically shows the configuration of a system capable of transmitting information from inside the patient's body to the outside of the patient's body to feedback related information. The energy receiving unit 1002 may include an energy source and/or an energy conversion device. In short, wireless energy is transmitted 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 receiving unit is configured to directly or indirectly supply the received energy to the energy use element of the implantation device 10 through the switch 1026. The energy balance between the received energy and the energy used for the implantation device 10 is determined by the internal energy receiving unit 1002, and transmission of wireless energy is controlled based on the determined energy balance. The energy balance provides an accurate indication of the correct amount of energy that is sufficient to properly operate the implantation device 10 but does not result in excessive temperature rise.

In FIG. 50, the patient's skin is represented by a vertical line 1005. In FIG. 50, the energy receiving unit comprises an energy conversion device 1002 located in the patient's body, preferably directly under the patient's skin 1005. Schematically, the implanted energy conversion device 1002 can be located subcutaneously in the patient's abdomen, chest, fascia (eg, abdominal wall) or any other suitable location. The implanted energy converting device 1002 converts the wireless energy E transmitted from an external energy source 1004a installed in the external energy transmitting device 1004 located outside the patient's skin 1005 into the implanted energy converting device 1002. It is supposed to be received in the vicinity.

As is well known in the art, wireless energy E is a device comprising a primary coil disposed within an external energy source 1004a and a secondary coil disposed within a neighboring implanted energy conversion device 1002. It is generally delivered by any suitable Transcutaneous Energy Transfer (TET) device. When current is supplied through the primary coil, voltage energy is induced to the secondary coil to supply power to the device's implanted energy use elements, for example, entering a transplanted 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 technology, TFT device or energy source, and any kind of wireless energy can be used.

The amount of energy received by the implanted energy receiver can be compared to the energy used by the implanted element of the device. The expression "energy used (used)" is understood to include the energy stored by the implanted element of the device. The control device 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 delivered. To deliver the correct amount of energy, the energy balance and the amount of energy required are determined by a determination device that includes an implanted internal control unit 1015 coupled between the switch 1026 and the implantation device 10. The internal control unit 1015 measures several characteristics of the implantation device 10 and measures various measurements obtained by any suitable sensor (not shown) indicating the amount of energy required for proper operation of the implantation device 10. It can be configured to receive. Further, the patient's current state may be detected by an appropriate measuring device or sensor, and a parameter indicating the patient's state may be provided. These features and/or parameters are indicated by the current state of the implant device 10, for example, the current state of the implant device 10 such as power consumption, operating mode, temperature, and parameters such as body temperature, blood pressure, heart rate, and breathing. It may be related to the patient's condition. Other types of patient physical parameters and device functional parameters are also disclosed herein.

In addition, an energy source such as a capacitor 1016 is connected to the implanted energy conversion device 1002 through the control unit 1015, and the received energy can be accumulated for later use in the implantation device 10. Alternatively or in addition, it is also possible that the characteristics of such capacitors indicating the required amount of energy can be measured. The capacitor may be replaced with a rechargeable battery, and the measured characteristics may be related to the current state of the battery, any electrical parameters such as energy use voltage, temperature, and the like. In order to provide sufficient voltage and current to the implantation device 10 and to avoid excessive overheating, the battery receives the correct amount of energy from the implanted energy conversion device 1002, that is, neither too much nor too little You will see that it should be optimally filled. The capacitor may be a capacitor with corresponding characteristics.

For example, the battery characteristics can be measured regularly to determine the current state of the battery, and stored as status information in appropriate storage means in the internal control unit 1015. Therefore, whenever the new measurement is made, the stored battery state information can be updated. According to this, it is possible to "calibrate" the state of the battery by delivering the correct amount of energy, thereby maintaining the battery in an optimal state.

Thus, the internal control unit 1015 of the judging device is a measurement made by a sensor or measuring device or patient of the implantation device 10, or by an implanted energy source (if using this energy source), or a combination thereof. Based on this, the energy balance and/or the currently required amount of energy (energy per unit of time or accumulated energy) is determined. The internal control unit 1015 is connected to an internal signal transmission unit 1027 that transmits a control signal indicating a required amount of energy determined by determination to an external signal receiving unit 1004c connected to the external control unit 1004b. The amount of energy transmitted from the external energy source 1004a may be adjusted according to the received control signal.

Alternatively, the determination device may include an external control unit 1004b. In this example, sensor measurement values can be sent directly to the external control unit 1004b, and the function of the internal control unit 1015 is determined by determining the energy balance and/or the currently required amount of energy by the external control unit 1004b Can be integrated into 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 transmitter 1027. The internal signal transmitter transmits the measured value to the external signal receiver 1004c and the external control unit 1004b. The energy balance and the amount of energy currently required can be determined by the external control unit 1004b based on these sensor measurements.

The solution according to the device of FIG. 50 is more efficient than the previous solution by using feedback of information indicative of the required energy, the actual energy use compared to the received energy, eg the implanted energy use element of the device. This is because it is based on the amount of energy compared to the energy ratio used by, the energy difference, or the energy reception ratio. The implantation device 10 may use the received energy for energy consumption or energy storage, such as an implanted energy source. The various parameters described above can be used where relevant and necessary, and eventually will be used as a tool to determine the actual energy balance. These parameters may be required for any action taken internally to operate the device specifically.

The internal signal transmitter 1027 and the external signal receiver 1004c may be implemented as separate units using appropriate signal transmission means such as radio wave signals, infrared (IR) signals, or ultrasonic signals. Alternatively, the internal signal transmitting unit 1027 and the external signal receiving unit 1004c basically use the same transmission technology, so as to transfer the control signal in the opposite direction to the energy transfer, the implanted energy conversion device 1002 and the external Each may be integrated into the energy source 1004a. The control signal can be modulated with respect to frequency, phase or amplitude.

Thus, the feedback information can be conveyed by separate communication systems, including the receiver and transmitter, or integrated into the energy system. According to the present invention, this integrated information feedback and energy system includes an implantable internal energy receiver for receiving wireless energy, the internal energy receiver comprising an internal first coil and a first electronic circuit connected to the first coil. Included, the energy transmission unit has a second electronic circuit connected to the external second coil and the second coil. The second coil outside the energy transmitting unit transmits radio energy received by the first coil of the energy receiving unit. The system further includes a power switch for switching on and off the connection of the first coil inside the first electronic circuit, thereby providing feedback information related to charging of the first coil and the power switch having the first coil inside. When switching the connection to the first electronic circuit on and off, it is received by an external energy transmitter in the form of a change in impedance of the load of the external second coil. In implementing the present system in the apparatus of FIG. 50, the switch 1026 is separated and 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, the power can be turned on/off using a transistor, MCU, MCPU, ASIC, FPGA, 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 device. The internal control unit 1015 generates a control signal indicating the required amount of energy, 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 be configured to determine the energy balance. In this case, the control signal can convey the measured values 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 based on the determined energy balance, for example, according to the received control signal. The process may be repeated intermittently at regular intervals during the energy transfer, or may be performed more continuously or less continuously during the energy transfer.

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

This system can also be used to obtain information about the coupling coefficient between coils in a TET system, to obtain an optimal position of the outer coil relative to the inner coil and calibrate the system to optimize energy transfer. In this case, the amount of energy transferred is compared with the amount of energy received. For example, in the case of moving the outer coil, the coupling coefficient can be changed, and by the precisely indicated movement, the outer coil can obtain an optimal position for energy transfer. Preferably, the external coil can be configured to correct the amount of energy transmitted, so that the determination device can obtain feedback information before the coupling coefficient is maximized.

This coupling factor can also be used as feedback for the energy transfer process. In this case, the energy system of the present invention includes an implantable internal energy receiver for receiving wireless energy and an external energy transmitter for transmitting wireless energy. The energy receiving unit includes an internal first coil and a first electronic circuit connected to the first coil. The external energy transmitter includes an external second coil and a second electronic circuit connected to the second coil. The second coil outside the energy transmitting unit transmits wireless energy received by the first coil of the energy receiving unit. The system further includes a feedback device for transmitting the amount of energy received in the first coil to the outside as feedback information. The second electronic circuit receives the feedback information and compares the amount of energy delivered by the second coil with feedback information related to the amount of energy received by the first coil to determine the coupling coefficient between the first coil and the second coil. And a determination device to obtain. The energy transmitting unit may adjust the transmitted energy according to the obtained coupling coefficient.

Referring to FIG. 51, although it has been described that non-invasive operation is possible by transmission of wireless energy for operation of the implantation device 10, the implantation device 10 may also be operated by wired energy. 51 shows an example. 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 that operates the implantation device 10. The external control unit 1004b controls the operation of the external switch 1026 so that the implantation device 10 operates properly.

52 shows an embodiment of a method of supplying received energy to the implantation device 10 and a method used by the implantation device 10. Similar to FIG. 50, the internal energy receiving unit 1002 receives wireless energy E from an external energy source 1004a controlled by the transmission control unit 1004b. The internal energy receiving unit 1002 may include a constant voltage circuit that supplies a constant voltage of energy to the implantation device 10, and is referred to as “constant voltage V” in the drawings. The internal energy receiving unit 1002 may include a constant current circuit that supplies energy of a constant current to the implantation device 10, and is indicated as “constant current C” in the drawings.

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

The energy supplied from the internal energy receiving unit 1002 is accumulated and/or is stored in a separate energy stabilization unit 1028 located outside the implantation device 10 before being used and/or stored by the implantation device 10. It can be stabilized by. Alternatively, the energy stabilization unit 1028 may be integrated into the internal energy receiving unit 1002. In either case, the energy stabilization unit 1028 may include a constant voltage circuit and/or a constant current circuit.

It should be noted that FIGS. 50 and 52 illustrate some possible but non-limiting implementations of how the various functional components shown are arranged and how they are connected to each other. Those skilled in the art will readily appreciate that many variations and modifications are possible within the scope of the present invention.

53 schematically shows an energy balance measurement circuit, ie an energy balance control system, of one of the proposed designs of a system for controlling the transmission of wireless energy. The energy balance measurement circuit is adjusted to 2.5V and has an associated output signal proportional to the energy imbalance. The derivative of this output signal shows how the value rises and falls and how quickly this change occurs. 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. Therefore, the digital information is transmitted to the external energy transfer device, so that the level of the transferred energy can be adjusted. Another possibility is that you can have a complete analog system using a comparator. The comparator compares the energy balance level with a predetermined maximum and minimum threshold, and sends information to the energy delivery device when the energy balance is outside the maximum and minimum thresholds.

53 shows a circuit implementation example of a system for transferring energy from outside of a patient's body to an implanted energy use element of the device of the present invention using inductive energy transfer. It is common to use an inductive energy transmission system using an external transmission coil and an internal reception coil. The receiving coil L1 is schematically illustrated in Fig. 53, but the transmitting coil is not.

The general concept of energy balance and the implementation of a method of transferring information to an external energy transmitter can be implemented by many different methods. 53 and the previously described method of evaluating and delivering information is only an example for implementing a control system.

Detailed circuit description

In Fig. 53, reference numerals Y1, Y2, Y3, and the like denote test points in the circuit. The elements in the figures and their values are values acting on specific implementations that are only one of many possible design options.

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

Those skilled in the art will appreciate that the various embodiments of the system can 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. 39-45, and the hydraulic valve switching device 1014 of FIG. 39 may be included in the embodiment of FIG. 38. The gear box 1024 may be included in the embodiment of FIG. 37. The switch can be any electronic circuit or component.

The embodiments described in connection with FIGS. 50, 52 and 53 provide a method and system for controlling the transmission of wireless energy to an implanted energy use element of an electrically operable device. These methods and systems can be defined in general terms as follows.

As described above, a method is provided for controlling the delivery of wireless energy supplied to an implanted energy use element of an implantation device. Wireless energy (E) is transmitted from an external energy source located outside 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 use element of the device, supplying the received energy directly or indirectly to this energy use element. The energy balance is established between the energy received by the internal energy receiver and the energy used in the device. The transmission of wireless energy E from the external energy source is controlled by this determined energy balance.

Wireless energy may be inductively transferred 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 wireless energy based on the determined energy balance change, a change in energy balance can be detected. The energy difference between the energy received by the internal energy receiving unit and the energy used in the medical equipment may be detected, and transmission of wireless energy may be controlled based on the detected energy difference.

When controlling the energy transmission, when indicating that the energy balance is increasing by detecting the change in energy balance, the amount of wireless energy transmitted can be reduced, and conversely, the energy balance by detecting the change in the detected energy balance If it indicates that this is decreasing, the amount of radio energy transmitted can be increased. The reduction/increase of the transmitted energy may correspond to the detected rate of change.

If the energy received by the detected energy difference indicates that it is greater than the energy used, the amount of wireless energy transmitted can be increased, and conversely, indicating that the energy received by the detected energy difference is less than the energy used. In the case, it is possible to reduce the amount of wireless energy transmitted.

As previously described, energy used in a medical device may be used to operate the medical device and/or may be used 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 physical parameters of the patient have been determined, energy may be transferred for use and storage according to a transmission rate per unit of time determined based on these parameters. The total amount of energy transmitted may be determined based on these parameters.

Detects the difference between the total amount of energy received by the internal energy receiver and the total amount of used and/or stored energy, and the detected difference is integrated over time of one or more measured electrical parameters related to energy balance (integral over time), this integral can be determined for the monitored voltage and/or current related to the energy balance.

Once a derivative over time of measured electrical parameters related to the amount of energy used and/or stored is determined, the derivative can be determined for the monitored voltage and/or current related to the energy balance.

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

In this case, the frequency of the electric pulse can be made substantially constant even when the first and/or second time intervals change. When the electric pulse is applied, the electric pulse can be kept constant, except for changing the first and/or second time intervals. The amplitude of the electric pulse can be made substantially constant, except for varying the first and/or second time intervals. Also, the electrical pulse can be changed by changing only the length of the first time interval between the successive leading edge and trailing edge of the electrical pulse.

Two or more series of electrical pulses may be supplied continuously, and when applying a series of pulses, the pulse train includes 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 supplied continuously, in this case of a second time interval between the trailing edge of the second electrical pulse in the first pulse train and the leading edge of the first electrical pulse in the second pulse train. Length may vary.

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

The circuit formed by the first electrical circuit and the external energy source may have a first characteristic time period or a first time constant, and in the case of effectively fluctuating the transmitted energy, this frequency time period may be a first characteristic time period or It may be within the range of the time constant or within a shorter range.

A system comprising a device as described above is provided to control the delivery of wireless energy supplied to a device's implanted energy use element. Broadly, the system includes a control device for controlling the transfer of radio energy from the energy transfer device, and an implantable internal energy receiver for receiving the transferred radio energy. The internal energy receiver is connected to the implantable energy use element of the device to supply the received energy directly or indirectly to the implantable energy use element. The system may further include a determining device configured to determine an energy balance between the energy received by the internal energy receiver and the energy used in the device's implantable energy use element. The control device controls the transfer of wireless 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 a portion of the energy conversion device 1002 to supply energy to the implantation device 10 through a power line. As another example, the battery may be made rechargeable. The power supply of the battery may be arranged at a location away from the device or may be included in the device.

In addition, the system can include any of the elements described below.

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

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

The judging device is configured to detect a difference between the energy received by the internal energy receiver and the energy used in the device's implantable energy use element. The control device controls the transmission of radio energy based on this detected energy difference.

-When the change in the detected energy balance indicates that the energy balance is increased, the control device controls the external energy transfer device to reduce the amount of wireless energy transmitted, and the change in the detected energy balance is the energy balance If this decrease is indicated, the amount of wireless energy transmitted is controlled by controlling the external energy transfer device. The increase/decrease in the amount of energy transferred corresponds to the amount of change detected.

-The control device controls the external energy transfer device to reduce the amount of wireless energy transmitted when the detected energy difference indicates that the received energy is more than the energy used; When the detected energy difference indicates that the received energy is less than the used energy, the external energy transfer device is controlled to increase the amount of wireless energy transmitted. The increase/decrease in the amount of energy transferred corresponds to the magnitude of the detected energy difference.

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

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

-A difference between the total amount of energy received by the internal energy receiver and the total amount of energy used and/or stored is detected, and the detected difference is integrated over time in one or more measured electrical parameters related to energy balance. If relevant, the determination device determines that it is an integral to the monitored voltage and/or current related to the energy balance.

-Once a derivative over time of the measured electrical parameters related to the amount of energy used and/or stored is determined, the judging device determines that this derivative is for the monitored voltage and/or current related to the energy balance. .

-The energy transfer device includes an external coil located outside the human body and an electric circuit that supplies power with electric pulses that transmit wireless energy to the external coil. The electrical pulse has a leading edge and a trailing edge, and the electrical circuit has a first time interval between a successive leading edge and a trailing edge and/or a second time between a successive trailing edge and a leading edge of the electrical pulse. It is configured to change the spacing, thereby changing the power of the wireless energy delivered. Therefore, the energy receiving unit receiving the transmitted wireless energy has changed power.

-The electrical circuit delivers electrical pulses to remain constant, except for the first and/or second time intervals.

-The electrical circuit has a time constant and is transmitted through the coil when the lengths of the first and/or second time intervals change by changing the first and second time intervals only within the range of the first time constant Let the power change.

The electrical circuit delivers a varying electrical pulse by changing only the length of the first time interval between the successive leading and trailing edges of the electrical pulse.

-The electric circuit is configured to continuously supply a row 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 electrical pulse in the first pulse train and the leading edge of the first electrical pulse in the second pulse train is changed by the first electrical circuit.

-The electrical circuit provides electrical pulses as pulses of substantially constant height, amplitude, intensity, voltage, current and/or frequency.

-The electric circuit has a time constant, and by changing the first and second time intervals only in the range of the first time constant, the lengths of the first and/or second time intervals are changed, and the power transmitted through the first coil Let change.

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

54-57 show in detail block diagrams of four different methods of powering hydraulically or pneumatically to an implantation device according to an embodiment of the present invention.

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

55 shows the implantation device 10 and fluid reservoir 1013. By moving the wall of the fluid reservoir or changing the size of the fluid reservoir in any other various ways, it is possible to freely flow the fluid at any time, without a valve, by adjustment of the implantation device 10.

56 shows an implantation device 10, a bidirectional pump 1009, and a fluid reservoir 1013.

57 shows a block diagram of an inverted sub-system with a first closed system controlling a second closed system. This servo system includes a fluid storage unit 1013 and a servo storage unit 1050. The servo storage 1050 mechanically controls the implantation device 10 by a mechanical connection 1054. The implantation device 10 has an expandable/contractable cavity. This cavity is preferably expanded or contracted by supplying hydraulic fluid by fluid connection with the implantation device 10 from a larger adjustable reservoir 1052. Alternatively, the cavity contains compressible and expandable gas under the control of the servo storage 1050.

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

In one embodiment, the fluid reservoir is located subcutaneously on the patient's skin and works by pressing the outer surface with a finger. The system is shown in Figures 58A-58C. In FIG. 58A, the flexible subcutaneous fluid reservoir 1013 is shown connected to a convex shaped sub-storage 1050 by a conduit 1011. This bellow shaped substorage 1050 is included within the flexible implant 10. In the state shown in Fig. 58A, the servo reservoir 1050 contains a minimum amount of fluid, and most of the fluid is in the fluid reservoir 1013. Since the servo storage 1013 and the implantation device 10 are mechanically connected, the external shape of the implantation device 10 may be contracted. That is, in this case, the implantation device 10 becomes smaller than its maximum volume. The maximum volume is indicated by a dotted line in the drawing.

FIG. 58B shows that the fluid stored in the fluid reservoir is conduit (FIG. 1011) indicates a state flowing to the servo storage unit 1050. This expansion causes the implantation device 10 to expand, thereby allowing the implantation device 10 to reach its maximum volume, thereby lengthening the gastric wall (not shown) in contact with the device.

The fluid reservoir 1013 preferably includes means 1013a for maintaining its shape even after compression. This is to ensure that the implantation device 10 remains in an extended position even when the user releases the fluid reservoir from being depressed, as schematically shown in the figure. According to this, the fluid reservoir acts as an on/off switch used in the system.

An embodiment relating to hydraulic or pneumatic operation will be described with reference to FIGS. 59 and 60A-60C. The block diagram of FIG. 59 includes a first closing system that controls the second closing 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 a mechanical connection unit 1054. The implantation device 10 with an expandable/contractable cavity is provided by a larger adjustable storage 1052 by supplying hydraulic fluid by fluid connection with the implantation device 10 from the adjustable storage 1052. Controlled.

This embodiment will be described with reference to Figs. 60A-60C. As in the previous embodiment, the fluid reservoir is located under the patient's skin and works by pressing the outer surface with a finger. The fluid storage unit 1013 is connected to the corrugated servo storage unit 1050 through a fluid by a conduit 1011. In the first closed systems 1013, 1011, 1050 shown in FIG. 60A, the servo reservoir 1050 contains a minimal amount of fluid, and most of the fluid is in the fluid reservoir 1013.

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

Similar to the embodiment described with reference to FIGS. 58A-58C, the fluid reservoir 1013 preferably includes means 1013a for maintaining its shape after compression. This is to ensure that the implantation device 10 remains in an 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 acts as an on/off switch used in the system.

Although the various elements described above are shown as having a specific arrangement in the drawings, it will be understood that their location may vary depending on their use.

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

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

The various features described above of the present invention can be combined in various ways unless clearly contradicted. The present invention has been described as a preferred embodiment and with reference to the accompanying drawings. Each feature of the various embodiments can be combined or modified, and such combination or modification is possible as long as it does not contradict the overall function of the device.

Claims (15)

An implantable medical device for implantation into a mammalian knee joint,
An artificial contact surface that replaces at least one contact surface of the knee joint and is configured to be lubricated when implanted in the knee joint;
A container comprising a movable wall portion defining a volume of the container;
At least one inlet configured to receive a lubricant from the container;
At least one channel at least partially integrated with the artificial contact surface, the channel in fluid communication with at least one inlet port for dispensing the lubricant to the surface of the artificial contact surface;
An actuating device configured to non-invasively transport the lubricant from the container to the artificial contact surface; And
Implantable injection port for refilling the container
Including,
The movable wall portion allows the container to move when it is refilled to increase the volume of the container. According to claim 1,
Wherein the artificial contact surface is an artificial tibial contact surface configured to replace at least one of the inner and lateral portions of the tibia contact surface of the knee joint. The method according to claim 1 or 2,
Wherein the artificial contact surface is an artificial femur contact surface configured to replace at least one of the inner and lateral portions of the femoral bone contact surface. The method according to claim 1 or 2,
The container is configured to be pre-filled with compressed lubricant, an implantable medical device. The method according to claim 1 or 2,
The operating device,
a. Energized operating device,
b. An electric actuator, and
c. A pump configured to pump lubricant from the container to the artificial contact surface to lubricate the artificial contact surface
Implantable medical device. The method according to claim 1 or 2,
And a valve configured to close the connection between the container and the artificial contact surface. The method according to claim 1 or 2,
The container is located in a unit separate from the artificial contact surface, and is configured to be connected to the artificial contact surface through a conduit, an implantable medical device. The method according to claim 1 or 2,
The movable wall portion is electrically driven and configured to move to change the volume of the container, wherein the implantable medical device. The method according to claim 1 or 2,
The implantable medical device
At least one outlet, and at least one additional channel at least partially integrated with the artificial contact surface,
An implantable medical device configured to enable circulation of lubricant through the outlet and out of the artificial contact surface and through the inlet to the artificial contact surface. The method according to claim 1 or 2,
a. An operating device configured to circulate the lubricant,
b. A container configured to add additional lubricant to the circulating lubricant, and
c. Filter configured to clean circulating lubricant
An implantable medical device further comprising at least one of the following. The method according to claim 1 or 2,
And the container is configured to provide pressure to the lubricant. The method according to claim 1 or 2,
The container,
a. Loaded with spring
b. Comprising a chamber configured to hold compressed gas,
c. Comprising an elastic wall configured to create pressure, and
d. Comprising parylene coated silicone elastic wall
Implantable medical device. The method according to claim 1 or 2,
Of the implantable hydraulic containers configured to control the implantable medical device passively and non-invasively, and are configured to be controlled by manually pressing a hydraulic container by a hydraulic switch connected to the patient, wireless remote control, and hydraulically connected to the implantable medical device System comprising at least one
Implantable medical device comprising a. The method according to claim 1 or 2,
System,
The system is
An internal energy source for powering implantable energy consuming parts of the implantable medical device; And
An internal energy source configured to supply energy non-invasively and wirelessly by an energy transfer device from outside the patient's body,
An implantable internal energy source included in the system that is rechargeable by energy transmitted from the energy transfer device,
At least one implantable energy consuming component of a system that supplies energy with wireless energy
An internal energy source, configured to transmit wireless energy to at least one of the
Implantable medical device comprising at least one of. The method according to claim 1 or 2,
A system further comprising at least one of a sensor and a measuring device,
The system is
At least one physical parameter of the patient; And
Functional parameters, including at least one of functional parameters related to energy transfer for charging an internal energy source and functional parameters related to the implantable medical device, as at least one functional parameter related to the implantable medical device.
Detect or measure at least one of the
The implantable medical device is from within the patient's body.
-Implantable internal control unit,
-An external control unit external to the patient's body,
-An external control unit through the internal control unit, external to the patient's body,
-Through the internal control unit according to the programming of the internal control unit performed by the external control unit, an external control unit external to the patient's body
At least one of the, further comprising a feedback device for transmitting the feedback information,
And the feedback information is related to at least one of at least one functional parameter related to the implantable medical device and at least one physical parameter of a patient.

Images