Operable implant comprising electrical motor and gear system

Abstract

To provide an operable implant adapted to be implanted in the body of a patient.SOLUTION: An operable implant comprises an operation device 110 and a body engaging portion. The operation device comprises a static part including a plurality of coils 132 and a movable part including a plurality of magnets 133. Sequential energization of the coils magnetically propels the magnets and thus propels the movable part. The operation device further comprises an enclosure 131 adapted to hermetically enclose the coils of the static part, such that a seal is created between the static part and the propelled movable part with the included magnets, such that the coils of the static part are sealed from the bodily fluids, when implanted.SELECTED DRAWING: Figure 20

Description

[Technical Field]

[0001] The present invention relates to the field of steerable implants, and devices, systems and methods for energizing and communicating with steerable implants. [Background technology]

[0002] Providing a reliable manipulation device for an energized and steerable implant has proven difficult. The hostile environment of the body affects all parts of the implant, with moving parts being particularly susceptible to body-derived fluids and fibrous tissue growth. The fibrous tissue eventually surrounds and encapsulates any foreign body placed within the body, which can affect the function of the implant. Therefore, a more reliable and versatile manipulation device for steerable implants would be advantageous. Summary of the Invention [Means for solving the problem]

[0003] A maneuverable implant adapted for implantation in a patient's body is provided. The maneuverable implant comprises a manipulation device and a body-engaging portion. The manipulation device comprises: a receiving unit for receiving wireless energy; and a first unit comprising a first gear system adapted to receive mechanical work having a first force and a second speed and to output mechanical work having a second, different force and a second, different speed. The manipulation device further comprises a second unit comprising an electric motor adapted to convert electrical energy into mechanical work, and a distance element comprising a conductor for transmitting electrical energy from the first unit to the second unit and a mechanical transmission member adapted to transmit mechanical work from the electric motor of the second unit to the gear system of the first unit. The distance element is adapted to separate the first unit and the second unit such that the receiving unit is not substantially affected by the second unit when receiving wireless energy.

[0004] According to one embodiment, the receiving unit comprises at least one coil adapted to convert received wireless energy in the form of a magnetic field into electrical energy, and may comprise a first coil having at least a first number of turns and a second coil having at least a second, different number of turns.

[0005] According to one embodiment, the gear system comprises: an operable element, a hollow cylindrical first gear having a first number of teeth on its outer circumference, and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first and second gears.

[0006] According to one embodiment, the operable element comprises at least one of: a planetary gear; and a structure or wheel that uses at least partial friction to interconnect with the first gear.

[0007] According to one embodiment, the second unit is adapted to receive as input a mechanical work output having a second different force and a second different speed from the first gear system, and to output mechanical work having a third different force and a third different speed. The gear system of the second unit may be connected in series with the gear system of the first unit via a mechanical transmission member of a distance element.

[0008] According to one embodiment, the first unit may comprise a second gear system adapted to receive as input mechanical work having a first force and velocity and to output mechanical work having a different force and velocity, the second gear system being connected in series with the first gear system.

[0009] According to any of the above embodiments, the first unit may be adapted to be placed in at least one of the following locations: subcutaneously; subcutaneously in the abdominal wall; and intra-abdominally.

[0010] The electric motor in any of the above embodiments may comprise a magnetic material, and the first unit may be substantially unaffected by the magnetic material of the second unit during wireless energy transmission.

[0011] The first gear system in any of the above embodiments may include a third gear, the inner side of which may have the same number of teeth as the outer side of the first gear, the teeth of the third gear adapted to interengage with the teeth of the first gear, thereby causing the third gear to rotate relative to the second gear along at least one interengaging position.

[0012] The second unit in any of the above embodiments may include at least one fixation portion for fixing the second unit to at least one of the fibrosis, fascia, and muscle layer toward the inside of the patient's subcutaneous space.

[0013] The distance element in any of the above embodiments may be adapted for placement through the muscle layer of the abdominal wall and / or fixation to the fascia facing the subcutaneous space.

[0014] According to one embodiment, the distance element is flexible, whereby the first and second units are movable relative to each other.

[0015] The mechanical transmission member in any of the above embodiments may be: a hydraulic tube for transmitting hydraulic pressure; a rotating shaft for transmitting rotational force; a flexible member for transmitting rotational force; a wire; a belt; a rod; a worm gear; and a gear for changing the rotational force by approximately 90 degrees. The mechanical transmission member may be selected from:

[0016] The steerable implant may comprise an enclosure adapted to sealingly surround the steerable implant.

[0017] According to one embodiment, the medical device may further comprise a metallic enclosure adapted to enclose at least one of the second unit and the distance element. The metallic enclosure may consist of at least one of: a titanium enclosure and / or an aluminum enclosure and / or a stainless steel enclosure.

[0018] One of the first and second units may comprise a battery adapted to store electrical energy received at the receiving unit.

[0019] The electric motor may include an electric motor selected from: an alternating current (AC) electric motor; a direct current (DC) electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0020] According to one embodiment, the implantable system further comprises: an operating device and a control unit for controlling at least one parameter of at least one of the body engaging portions.

[0021] In one embodiment, the electric motor is an alternating current (AC) motor and the control unit may comprise a frequency converter for changing the frequency of the alternating current to control the alternating current motor.

[0022] The first unit of the maneuverable implant may comprise a hydraulic pump adapted to convert mechanical work into hydraulic power for hydraulically powering the maneuverable body-engaging portion. The hydraulic pump may be connected to a power output of the first gear system or the second gear system. The hydraulic pump may be a hydraulic pump selected from: at least one reservoir acting as a pump by a wall moving by mechanical work; at least one reservoir acting as a pump to move a fluid by a change in volume; at least one valveless pump; at least one valve pump; at least one peristaltic pump; at least one membrane pump; at least one gear pump; and at least one bellows pump.

[0023] According to one embodiment, the first unit comprises a reservoir for supplying fluid to the hydraulically operable body engaging portion.

[0024] The maneuverable implant may comprise a third unit comprising a second reservoir for supplying fluid to the hydraulically maneuverable body engaging portion, said reservoir being maneuverable and comprising at least one movable wall portion.

[0025] In all cases where movement of at least one movable wall portion is possible, the reservoir may comprise at least one of: at least one bellows-shaped portion, a shape adapted to allow movement even when covered by fibrosis; and a plate-like surface.

[0026] The reservoir in any of the above embodiments may be in fluid communication with the hydraulically operable body engaging portion, and the reservoir may be adapted to operate the hydraulically operable body engaging portion by movement of the at least one movable wall portion. The reservoir may be at least one of circular and donut-shaped.

[0027] The steerable implant may further comprise a threaded member arranged to move a wall portion of the reservoir.

[0028] In one embodiment, the operable implant further comprises at least one of a pressure sensor, a flow sensor and a position sensor arranged in connection with at least one of the pump and the reservoir to measure the pressure and / or volume in the reservoir and the pressure or flow rate from the hydraulic pump.

[0029] The first unit of any of the above embodiments of the operable implant may include an inlet for supplying fluid to at least one of the other / above reservoirs and the other / above hydraulically operable body engaging portions.

[0030] According to one embodiment, at least one of the first unit and the distance element may be free of at least one of: metallic and magnetizable parts.

[0031] At least one of the first unit and the distance element may be free of magnetic components.

[0032] The first unit of the steerable implant may comprise a communication unit adapted for wireless communication with an external unit outside the patient's body.

[0033] The manipulable element may be adapted to bias and maintain the first gear biased so that the teeth of the first gear interengage with the teeth of the second gear in at least one of one position, two positions, three positions, four or more positions, the two, three or four positions being angularly spaced apart positions separated by positions where the teeth do not interengage.

[0034] A steerable implant for implantation into a patient's body is provided, the steerable implant comprising a steering device and a body-engaging portion. The steering device comprises an electric motor comprising: a set of coils circularly distributed around a rotation axis of the electric motor; a set of magnets connected to a rotatable structure that at least partially axially overlaps the coils, whereby sequential energization of the coils magnetically propels the magnets and rotates the rotatable structure about the rotation axis. The steering device also comprises a gear system comprising: a steering element; a first gear having a hollow cylindrical shape and including a first number of teeth on its outer circumference; and a second gear having a hollow cylindrical shape and including a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby producing relative rotation between the first and second gears, comprising a gear system. The second gear has a smaller diameter than the rotatable structure and is at least partially disposed in the same axial plane, whereby the rotatable structure at least partially axially overlaps with the second gear, whereby the gear system is at least partially disposed inside the electric motor. Locating the gear system at least partially inside the electric motor results in an extremely compact and efficient design.

[0035] The operable element may be adapted to bias the first gear and maintain the first gear biased so that the teeth of the first gear interengage with the teeth of the second gear in at least one of: one position, two positions, three positions, four or more positions, the two, three and four positions being angularly spaced positions separated by positions where the teeth do not interengage.

[0036] According to one embodiment of the manipulable implant, the manipulable element may be adapted to bias the first gear and maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear at at least two angularly spaced positions separated by positions where the teeth do not interengage.

[0037] The manipulable element may comprise at least one of: a star gear; and a structure or wheel that uses at least partial friction to interconnect with the first gear.

[0038] According to one embodiment, the operating device further comprises a second gear system, the second gear system comprising: an operable element; a hollow cylindrical first gear with a first number of teeth on its outer circumference; and a hollow cylindrical second gear with a greater number of teeth on its inner surface than the first gear, the operable element being adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and operating the operable element comprises: Advancing the position generates relative rotation between the first gear and the second gear, and the first gear of the first gear system is directly or indirectly connected to an operable element of the second gear system, whereby the first gear system is connected in series with the second gear system, whereby the first gear system receives mechanical work having a first force and a first speed and outputs mechanical work having a second, different force and a second, different speed, and the second gear system receives the output mechanical work from the first gear system as an input and outputs mechanical work having a third, different force and a third, different speed.

[0039] The first gear system and the second gear system in any of the above embodiments may be positioned coaxially along the rotational axes of the first gear system and the second gear system.

[0040] The second gear of at least one of the first gear system and the second gear system may have a smaller diameter than the rotatable structure and may be at least partially arranged in the same axial plane, whereby the rotatable structure at least partially axially overlaps with the second gear of at least one of the first gear system and the second gear system, whereby at least one of the first gear system and the second gear system is at least partially arranged inside the electric motor.

[0041] The first gear and the second gear of the second gear system may have a larger diameter than the rotatable structure and may be at least partially arranged in the same axial plane, whereby the first gear and the second gear of the second gear system at least partially axially overlap with the rotatable structure, whereby the electric motor is at least partially arranged inside the second gear system.

[0042] According to one embodiment, the gearbox further comprises a radially extending connecting structure that directly or indirectly connects a first gear of the first gear system to an operable element of the second gear system for transmitting forces from the first gear system to the second gear system.

[0043] The first gear system of the steerable implant can include a third gear, the inner side of which can include the same number of teeth as the outer side of the first gear, the teeth of the third gear adapted to interengage with the teeth of the first gear, thereby causing the third gear to rotate along angularly spaced positions relative to the second gear.

[0044] A first gear of the first gear system may be indirectly connected to an operable element of the second gear system via a third gear.

[0045] The rotatable structure of the manipulable element may be disposed radially inside the circularly distributed coils or may be disposed radially outside the circularly distributed coils.

[0046] According to one embodiment, the steerable implant further comprises a coil enclosure adapted to surround the coil such that the coil remains enclosed during manipulation of the manipulation device.

[0047] According to one embodiment, a first gear of at least one of the first gear system and the second gear system may be directly or indirectly connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force.

[0048] The threaded member of the operable implant may be directly or indirectly connected to a movable wall portion of the first reservoir for varying the volume of the first reservoir.

[0049] The threaded member may be directly or indirectly connected to a movable wall portion of the second reservoir for varying the volume of the second reservoir, such that movement of the movable wall portion of the first reservoir in a first direction by the threaded member causes the first reservoir to expand, increasing the volume of the reservoir, while movement of the movable wall of the second reservoir in the first direction by the threaded member causes the second reservoir to contract, decreasing the volume of the second reservoir.

[0050] The first reservoir in any of the above embodiments may be in fluid communication with a first hydraulically operable body engagement portion and the second reservoir may be in fluid communication with a second hydraulically operable body engagement portion. Operation of the electric motor in a first direction via a gear system and a direct or indirect connection of the gear system with a threaded member causes: fluid to be transported from the first reservoir to the first hydraulically operable body engagement portion and fluid to be transported from the second hydraulically operable body engagement portion to the second reservoir.

[0051] The reservoir in any of the above embodiments may be at least one of: circular and donut-shaped.

[0052] According to one embodiment of the medical device, the operating device may comprise a circular reservoir surrounding the operating device, the circular reservoir may comprise a movable wall portion adapted to compress and expand the circular reservoir, thereby varying the volume of the reservoir, and the movable wall portion may be connected to the operating device, operation of the operating device varying the volume of the circular reservoir.

[0053] According to one embodiment of the maneuverable implant, a portion of the wall of the reservoir comprises at least one of: a bellows structure; a shape adapted to allow movement even when covered by fibrosis; and a plate-like surface, in all cases allowing movement of at least one movable wall portion and allowing compression and / or expansion of the reservoir.

[0054] According to one embodiment, the maneuverable implant further comprises a peristaltic pump, the peristaltic pump comprising a hollow member for transporting fluid, and an maneuverable compression member adapted to engage and compress the hollow member. The first gear of the maneuverable implant may be directly or indirectly connected to the compression member, and operation of the electric motor operates the compression member such that fluid is transported into the hollow member. The maneuverable compression member may be connected to the third gear of any of the above embodiments.

[0055] The hollow member of the peristaltic pump may form a loop or part of a loop adapted to at least partially surround a manipulation device at least partially in the same axial plane, and the manipulation device may be adapted to urge a compression member, whereby the compression member compresses the hollow member towards the outer periphery of the loop or part of the loop.

[0056] According to one embodiment, the operating device comprises an alternating current (AC) motor, the operating device further comprising a frequency converter for changing the frequency of the alternating current to control the alternating current motor.

[0057] According to one embodiment of the steerable implant, the steerable implant further comprises a separate unit comprising a receiving unit adapted to receive wireless energy transmitted from outside the body, which may comprise at least one coil adapted to convert the received wireless energy in the form of a magnetic, electric or electromagnetic field into electrical energy.

[0058] The receiving unit in the above embodiments may comprise a first coil having at least a first number of turns and a second coil having at least a second, different number of turns.

[0059] According to one embodiment, the separate units may be adapted to be placed subcutaneously and / or subcutaneously in the abdominal wall.

[0060] The maneuverable implant according to any one of the above embodiments may further comprise at least one fixation portion for fixing at least a portion of the maneuverable implant to at least one of the fibrosis, fascia and muscle layer, toward the inside of the patient's subcutaneous space.

[0061] The steerable implant according to any one of the above embodiments may comprise a distance element connecting the steering device and the separate unit, the distance element may further comprise a conductor adapted to transmit electrical energy between the separate unit and the steering device. The distance element may be adapted to be positioned through the muscle layer of the abdominal wall and / or to be anchored to the fascia facing the subcutaneous space.

[0062] According to one embodiment, the distance element may be flexible, whereby the first and second units are movable relative to each other.

[0063] The separate unit in any of the above embodiments may comprise a reservoir for supplying fluid to the hydraulic implant.

[0064] The distance element in any of the above embodiments may comprise a fluid conduit for transporting fluid from the manipulation device to the separate unit or vice versa to control the size of the reservoir. The distance element may further comprise a mechanical transmission member adapted to transmit mechanical work from the manipulation device to the separate unit. The mechanical transmission member may comprise a mechanical transmission member selected from: a hydraulic tube for transmitting hydraulic force; a rotating shaft for transmitting rotational force; a flexible member for transmitting rotational force; a wire; a belt; a rod; a worm gear; and a gear for changing the rotational force by approximately 90 degrees.

[0065] The steerable implant may further comprise an enclosure adapted to sealingly surround the steering device and the separate units such that the steering device and the separate units are sealed from body fluids upon implantation.

[0066] At least one of the operating device and the separate unit may comprise a battery adapted to store electrical energy received by the receiving unit. The separate unit may further comprise: a reservoir and / or an inlet for supplying fluid to at least one of the hydraulically operable body engaging portions.

[0067] The separate unit from the energy receiving unit may be free of metallic and / or magnetizable and / or magnetic parts so as not to interfere with wireless energy transmission.

[0068] The separate unit may further comprise: an operating device; and a control unit for controlling at least one parameter relating to at least one of the body engaging portions.

[0069] The separate unit may comprise a communication unit adapted for wireless communication with an external unit outside the patient's body.

[0070] In one embodiment, the maneuverable implant may comprise a hydraulic pump, the hydraulic pump comprising: at least one reservoir having a wall that moves due to mechanical work to act as a pump; at least one reservoir that changes volume to move a fluid that acts as a pump; at least one valveless pump; at least one valve pump; at least one peristaltic pump; at least one membrane pump; at least one gear pump; and at least one bellows pump. is selected from.

[0071] The steerable implant may comprise an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0072] A steerable implant adapted for implantation in a patient's body, said steerable implant comprising a steering device and a body engaging portion, said steering device comprising an axial electric motor comprising: a set of coils circularly distributed around a rotation axis of the electric motor; and a set of magnets connected to a radially extending rotatable structure at least partially radially overlapping said magnets, whereby sequential energization of said coils causes magnetic forces to urge the magnets axially and rotate the rotatable structure about the rotation axis. The manipulable implant further comprises a gear system comprising: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the manipulable element is adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and manipulation of the manipulable element advances said positions, thereby generating relative rotation between the first and second gears. The gear system and axial-type electric motor are coaxially arranged along the rotational axis of the electric motor, creating a compact design with a small number of moving parts.

[0073] The operable element may comprise at least one of: a planetary gear; and a structure or wheel that uses at least partial friction to interconnect with the first gear.

[0074] According to one embodiment, the first set of coils is circularly distributed around the rotational axis of the electric motor and positioned on a magnetizable core structure, the radially extending rotatable structure comprising a rotatable disk, the magnetizable core structure and the rotatable disk being coaxially positioned, and the rotatable disk being connected to a drive shaft that is connected to the manipulable element.

[0075] According to one embodiment, the manipulation device further comprises a second magnetizable core structure comprising a second set of coils, the second magnetizable core structure being coaxially positioned to at least partially overlap the magnets of the rotatable disk, whereby the first set of coils urges the magnets to a first side thereof and the second set of coils urges the magnets to a second side thereof.

[0076] In one embodiment, the circumference of the circular shape of at least one of the first and second coil sets is smaller than the inner diameter of the first gear, and the first and second coil sets are positioned in the same axial plane as the first gear, thereby positioning the axial electric motor at least partially inside the gear system.

[0077] According to one embodiment, the rotating disc is directly connected to the operable element.

[0078] The steerable implant may further comprise a coil enclosure adapted to surround the coil such that the coil remains surrounded and spaced apart from the magnet during operation of the steering device.

[0079] According to one embodiment, the manipulable element is adapted to bias and maintain the first gear biased so that the teeth of the first gear interengage with the teeth of the second gear in one of one, two, three, four or more positions, the two, three and four positions being angularly spaced apart positions separated by positions where the teeth do not interengage.

[0080] The manipulable implant manipulation device may further comprise a second gear system, the second gear system comprising: a manipulable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the manipulable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and manipulation of the manipulable element advances the positions, thereby generating relative rotation between the first gear and the second gear. A first gear of the first gear system is directly or indirectly connected to an operable element of the second gear system, whereby the first gear system is connected in series with the second gear system, whereby the first gear system receives mechanical work having a first force and a first speed and outputs mechanical work having a second, different force and a second, different speed, and the second gear system receives the output mechanical work from the first gear system as an input and outputs mechanical work having a third, different force and a third, different speed.

[0081] The first gear system and the second gear system may be coaxially positioned along the rotational axes of the first gear system and the second gear system.

[0082] The maneuverable implant may further comprise a radially extending connecting structure that directly or indirectly connects a first gear of the first gear system to a maneuverable element of the second gear system for transmitting force from the first gear system to the second gear system.

[0083] The first gear system in any of the above embodiments may include a third gear, the inner side of which may have the same number of teeth as the outer side of the first gear. The teeth of the third gear may be adapted to interengage with the teeth of the first gear, causing the third gear to rotate along angularly spaced positions relative to the second gear.

[0084] According to one embodiment, the first gear of the first gear system is indirectly connected to the operable element of the second gear system via the third gear of any of the above embodiments.

[0085] The first gear of the first gear system may be directly or indirectly connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force.

[0086] According to one embodiment, the threaded member may be directly or indirectly connected to a movable wall of the first or second reservoir to vary the volume of the reservoir.

[0087] In one embodiment, movement of the movable wall of the first reservoir in a first direction by the threaded member causes the first fluid reservoir to expand and the volume of the first fluid reservoir to increase, while movement of the movable wall of the second reservoir in the first direction by the threaded member causes the second reservoir to contract and the volume of the second reservoir to decrease.

[0088] The first reservoir of the operable implant may be in fluid communication with a first hydraulically operable body engaging portion and the second reservoir is in fluid communication with a second hydraulically operable body engaging portion, wherein operating the electric motor in a first direction via a gear system and direct or indirect connection of the gear system with a threaded member: transports fluid from the first reservoir to the first hydraulically operable body engaging portion and transports fluid from the second hydraulically operable body engaging portion to the second reservoir.

[0089] The reservoir in any of the above embodiments may be at least one of circular and donut-shaped. In one embodiment, the manipulation device comprises a circular reservoir surrounding the manipulation device, the circular reservoir comprising a movable wall portion adapted to compress and expand the circular reservoir to vary the volume of the reservoir, the movable wall portion connected to the manipulation device, manipulation of the manipulation device varying the volume of the circular reservoir.

[0090] A portion of the wall of the reservoir may have at least one of: a bellows structure; a shape adapted to allow movement even when covered by fibrosis; and a plate-like surface, in all cases allowing movement of at least one movable wall portion and allowing compression and / or expansion of the reservoir.

[0091] The steerable implant further comprises a peristaltic pump comprising a hollow member for transporting fluid and an operable compression member adapted to engage and compress the hollow member, the first gear being in direct or indirect communication with the compression member whereby operation of the electric machine operates the compression member to transport fluid into the hollow member.

[0092] 23. The operable implant of embodiment 22, wherein the operable compression member connects to the third gear of any of the preceding embodiments.

[0093] The hollow member of the peristaltic pump forms a loop or a portion of a loop adapted to at least partially surround a manipulation device at least partially in the same axial plane, the manipulation device adapted to urge a compression member, whereby the compression member compresses the hollow member towards the outer periphery of the loop or portion of the loop.

[0094] According to one embodiment, the operating device comprises an alternating current (AC) motor, the operating device further comprising a frequency converter for changing the frequency of the alternating current to control the alternating current motor.

[0095] The steerable implant in any of the above embodiments may further comprise a separate unit comprising a receiving unit adapted to receive wireless energy transmitted from outside the body. The separate unit may be adapted to be placed at least one of subcutaneously and subcutaneously in the abdominal wall. The separate unit may comprise a reservoir for supplying fluid to the hydraulic implant.

[0096] According to one embodiment, the receiving unit comprises at least one coil adapted to convert received wireless energy in the form of a magnetic, electromagnetic field into electrical energy, and may comprise a first coil having at least a first number of turns and a second coil having at least a second, different number of turns.

[0097] The maneuverable implant may comprise at least one fixation portion for fixing at least a portion of the maneuverable implant to at least one of the fibrosis, fascia and muscle layer and toward the interior of the patient's subcutaneous space.

[0098] The steerable implant may further comprise a distance element connecting the steering device and the separate unit, and the distance element may comprise a conductor adapted to transmit electrical energy between the separate unit and the steering device.

[0099] The distance element may be adapted to be placed through the muscle layer of the abdominal wall and / or to be secured to the fascia facing the subcutaneous space.

[0100] The distance element may be flexible, allowing the first and second units to move relative to each other.

[0101] The distance element in any of the above embodiments may comprise a fluid conduit for transporting fluid to or from the manipulation device to control the size of the reservoir.

[0102] The distance element may further comprise a mechanical transmission member adapted to transmit mechanical work from the operating device to the separate unit, which may be a mechanical transmission member selected from: a hydraulic tube for transmitting hydraulic force; a rotating shaft for transmitting rotational force; a flexible member for transmitting rotational force; a wire; a belt; a rod; a worm gear; and a gear for changing the rotational force by about 90 degrees.

[0103] The steerable implant may further comprise an enclosure adapted to sealingly surround the steering device and the separate units such that the steering device and the separate units are sealed from body fluids upon implantation.

[0104] At least one of the operating device and the separate unit may comprise a battery adapted to store the electrical energy received at the receiving unit.

[0105] The separate unit in any of the above embodiments may include an inlet for supplying fluid to at least one of the other or the above reservoir and the hydraulically operable body engaging portion.

[0106] In one embodiment, the separate unit separate from the energy-receiving unit may be free of at least one of: metallic parts, magnetizable parts and magnetic parts.

[0107] The separate unit may further comprise: an operating device; and a control unit for controlling at least one parameter relating to at least one of the body engaging portions.

[0108] The separate unit may comprise a communication unit adapted for wireless communication with an external unit outside the patient's body.

[0109] According to one embodiment, the coil enclosure in any of the above embodiments may comprise a material selected from: a carbon material; a boron material; a mixture of materials; a Peek® material; an alloy of materials; a metallic material; titanium; aluminum; a ceramic material; a polymeric material; polyurethane; polyetheretherketone silicone; and Parylene® coated silicone.

[0110] The steering device of the steerable implant in any of the above embodiments may comprise an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0111] The present invention also provides a steerable implant adapted for implantation in a patient's body, the steerable implant comprising a steering device and a body-engaging portion. The steering device may comprise an electric motor comprising a stationary portion comprising a plurality of coils and a movable portion comprising a plurality of magnets, whereby sequential energization of the coils causes magnetic force to propel the magnets, and thereby the movable portion. The steering device may further comprise an enclosure adapted to hermetically surround the coils of the stationary portion, whereby a seal is created between the stationary portion and the propelled movable portion with the included magnets, such that the coils of the stationary portion are sealed from body fluids upon implantation.

[0112] According to one embodiment, the operating device further comprises a control unit for controlling at least one of the operating device and the body engagement portion, and the enclosure is adapted to enclose the coil and the control unit.

[0113] The operating device of the operable implant may further comprise at least one electrical circuit adapted to indirectly receive energy derived from wireless energy supplied from outside the patient's body, and the enclosure adapted to surround the coil and the electrical circuit.

[0114] According to one embodiment, the steerable implant comprises a separate wireless energy receiving unit comprising at least one coil adapted to convert received wireless energy in the form of a magnetic, electric or electromagnetic field into electrical energy.

[0115] According to one embodiment, the operable implant comprises a distance element adapted to create a distance between the receiving unit and the electric motor such that the receiving unit remains substantially unaffected by metallic and / or magnetic parts of the stationary or moving parts of the electric motor.

[0116] The electric motor in any of the above embodiments may be an axial-type electric motor, in which: the coils are circularly distributed around the rotation axis of the implantable electric motor, whereby the central axes of the coil spirals extend in the axial direction of the implantable electric motor, parallel to the rotation axis; the moving part comprises a radially extending rotor, on which magnets are circularly distributed around the rotation axis, facing the coils in the axial direction, whereby the magnets at least partially radially overlap the coils, whereby sequential energization of the coils propels the magnets axially by magnetic force, causing rotation of the rotor around the rotation axis of the electric motor.

[0117] In an alternative embodiment, the electric motor may be a radial electric motor: the coils are circularly distributed around the rotation axis of the implantable electric motor, whereby the central axes of the coil spirals extend radially of the rotation axis of the implantable electric motor and approximately perpendicular to the rotation axis; the moving part may comprise an axially extending rotor, on which magnets are circularly distributed around the rotation axis and face the coils radially, whereby the magnets at least partially axially overlap said coils, whereby sequential energization of said coils propels the magnets by magnetic force, causing rotation of the rotor around the rotation axis of the electric motor.

[0118] In an alternative embodiment, the electric motor is a linear electric motor: the coils are distributed linearly along the direction of movement of the movable part; the movable part comprises magnets distributed linearly along the direction of movement of the movable part, whereby sequential energization of the coils propels the magnets by magnetic force, generating linear movement of the movable part.

[0119] The implantable electric motor may be an alternating current (AC) electric motor, and the control unit may comprise a frequency converter for changing the frequency of the alternating current to control the alternating current electric motor.

[0120] According to one embodiment, the implantable electric motor further comprises a second enclosure adapted to surround the moving part so as to seal the moving part from body-derived fluids when implanted.

[0121] The second enclosure may be sealingly connected to the first enclosure, whereby the enclosure wall between the moving part and the stationary part participates in sealing both the first and second enclosures. The first and / or second enclosures may comprise a material selected from: a carbon material; a boron material; a mixture of materials; a Peek® material; an alloy of materials; a metallic material; titanium; aluminum; a ceramic material; a polymeric material; polyurethane; polyetheretherketone; silicone; and Parylene® coated silicone.

[0122] According to one embodiment, the second enclosure is hermetically connected to the first enclosure, whereby both the movable part and the distance element between the movable part and the stationary part are sealed by the second enclosure.

[0123] The motor may further comprise a gear system adapted to receive as input mechanical work having a first force and velocity from a rotating portion of the electric motor, and to output mechanical work having a different force and velocity.

[0124] The gear system may further comprise: an operable element, a hollow cylindrical first gear having a first number of teeth on its outer circumference, and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first and second gears.

[0125] According to one embodiment, the second gear has a relatively small diameter and is at least partially arranged in the same axial plane as at least one of the movable part and the stationary part, whereby at least one of the movable part and the stationary part at least partially axially overlaps with the second gear, whereby the gear system is at least partially arranged inside the electric motor.

[0126] The manipulable implant may have a manipulable element adapted to bias and maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear in at least one of one position, two positions, three positions, four or more positions, the two, three and four positions being angularly spaced apart positions separated by positions where the teeth do not interengage.

[0127] According to one embodiment, the operable element is adapted to bias the first gear and to maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear at at least two angularly spaced positions separated by positions where the teeth do not interengage.

[0128] The operating device in any of the above embodiments may further include a second gear system including: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the operable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances the position, thereby generating relative rotation between the first gear and the second gear. A first gear of the first gear system is directly or indirectly connected to an operable element of the second gear system, whereby the first gear system is connected in series with the second gear system, whereby the first gear system receives mechanical work having a first force and a first speed and outputs mechanical work having a second, different force and a second, different speed, and the second gear system receives the output mechanical work from the first gear system as an input and outputs mechanical work having a third, different force and a third, different speed.

[0129] The first gear system and the second gear system in any of the above embodiments are positioned coaxially along the rotational axes of the first gear system and the second gear system.

[0130] The second gear of at least one of the first and second gear systems may have a smaller diameter than the rotatable structure of any of the previous embodiments and may be at least partially disposed in the same axial plane, whereby the rotatable structure at least partially axially overlaps with the second gear of at least one of the first and second gear systems, whereby at least one of the first and second gear systems is at least partially disposed inside the electric motor.

[0131] In one embodiment, the first gear and the second gear of the second gear system may have a larger diameter than the rotatable structure and are at least partially disposed in the same axial plane, whereby the first gear and the second gear of the second gear system at least partially axially overlap with the rotatable structure, whereby the electric motor is disposed at least partially inside the second gear system.

[0132] The maneuverable implant may further comprise a radially extending connecting structure that directly or indirectly connects a first gear of the first gear system to a maneuverable element of the second gear system for transmitting force from the first gear system to the second gear system.

[0133] The first gear system may include a third gear, the inner side of which may have the same number of teeth as the outer side of the first gear, and the teeth of the third gear may be adapted to interengage with the teeth of the first gear, such that the third gear rotates along angularly spaced positions relative to the second gear.

[0134] According to one embodiment, the first gear of the first gear system is indirectly connected to the operable element of the second gear system via the third gear of the embodiment.

[0135] The rotatable structure in any of the above embodiments may be positioned radially inside the circularly distributed coils.

[0136] The rotatable structure may be positioned radially outside the circularly distributed coils.

[0137] In any of the above embodiments, the coil may remain enclosed during operation of the operating device.

[0138] At least one first gear of the first gear system and the second gear system may be directly or indirectly connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, and the threaded member may be directly or indirectly connected to a movable wall portion of the reservoir.

[0139] In any of the above embodiments, the maneuverable implant may include at least one fixation portion for fixing at least a portion of the maneuverable implant to at least one of the fibrosis, fascia, and muscle layer toward the interior of the patient's subcutaneous space.

[0140] The steerable implant may further comprise a separate unit comprising a receiving unit adapted to receive wireless energy transmitted from outside the body.

[0141] The manipulable implant may further comprise a first reservoir in fluid communication with the hydraulically manipulable body engaging portion. The manipulating device may be adapted to: cause transport of fluid from the first reservoir to the hydraulically manipulable body engaging portion.

[0142] A portion of the wall of the reservoir may have at least one of: a bellows structure, a shape adapted to allow movement even when covered by fibrosis, and a plate-like surface, in all cases allowing movement of at least one movable wall portion and allowing compression and / or expansion of the reservoir.

[0143] According to one embodiment, the operating device comprises a hydraulic pump for transporting fluid from a first reservoir to the hydraulically operable body engaging portion, which may be a hydraulic pump selected from: at least one reservoir having a wall moved by mechanical work acting as a pump; at least one reservoir whose volume changes to move fluid acting as a pump; at least one valveless pump; at least one valve pump; at least one peristaltic pump; at least one membrane pump; at least one gear pump; and at least one bellows pump.

[0144] The electric motor may be an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0145] The operating device comprises: a first unit comprising a receiving unit for receiving wireless energy and a first gear system adapted to receive mechanical work having a first force and a second different speed and to output mechanical work having a second, different force and a second, different speed; a second unit comprising an electric motor adapted to convert electrical energy into mechanical work; and a distance element comprising a conductor for transmitting electrical energy from the first unit to the second unit and a mechanical transmission member adapted to transmit mechanical work from the electric motor of the second unit to the gear system of the first unit, the distance element being adapted to separate the first unit and the second unit such that the receiving unit is not substantially affected by the second unit when receiving wireless energy.

[0146] According to one embodiment, the second unit is adapted to receive as input a mechanical work output having a second different force and a second different speed from the first gear system and to output mechanical work having a third different force and a third different speed, and the gear system of the second unit is connected in series with the gear system of the first unit via a mechanical transmission member of the distance element.

[0147] The first unit may include a second gear system adapted to receive as input mechanical work having a first force and velocity and to output mechanical work having a different force and velocity, and the second gear system may be connected in series with the first gear system.

[0148] The first unit of the steerable implant may be adapted to be placed in at least one of the following locations: subcutaneously; subcutaneously in the abdominal wall; and intra-abdominally.

[0149] The motor may comprise a magnetic material, and the first unit may be adapted to be substantially unaffected or not significantly affected by the magnetic material of the second unit during wireless energy transmission.

[0150] The first unit may comprise a reservoir for supplying fluid to the hydraulically operable body engaging portion.

[0151] The first unit may comprise a hydraulic pump adapted to convert mechanical work into hydraulic power for powering the hydraulically operable body engaging portion, the hydraulic pump being connected to a force output of the first gear system or the second gear system.

[0152] The manipulable implant may further comprise a gear system comprising: a manipulable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The manipulable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage. Manipulation of the manipulable element advances the positions, thereby generating relative rotation between the first gear and the second gear. The gear system and the axial-type electric motor are coaxially arranged along the rotational axis of the electric motor.

[0153] According to one embodiment, the operable element comprises at least one of a planetary gear and a structure or wheel that uses at least partial friction to interconnect with the first gear.

[0154] The first set of coils, circularly distributed around the rotational axis of the electric motor, may be positioned on a magnetizable core structure, and the radially extending rotatable structure may comprise a rotatable disk, the surface portion of the magnetizable core structure and the rotatable disk being coaxially positioned, and the rotatable disk being connected to a drive shaft that is connected to the manipulable element.

[0155] In one embodiment, the operating device includes: an electric motor having a force output; a gear system connected to the force output of the electric motor, the gear system comprising an operable element, a first gear having a hollow cylindrical shape with a first number of teeth on an outer circumference thereof, and a second gear having a hollow cylindrical shape with a greater number of teeth on an inner surface thereof than the first gear, the operable element adapted to engage the inside of the first gear such that the outside of the first gear is pressed against the inside of the second gear such that the teeth of the first gear interengage with the teeth of the second gear at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances the positions thereby generating relative rotation between the first gear and the second gear; and a force output of the gear system connected to the first gear of the gear system and adapted to directly or indirectly power a body engaging portion, the force output of the gear system comprising a magnetic coupler for magnetically connecting directly or indirectly to the body engaging portion for powering; and An enclosure may be provided for sealingly enclosing the operating device.

[0156] According to one embodiment, the magnetic coupler comprises an inner rotatable structure located inside an enclosure comprising at least one magnet or portion comprising magnetic or magnetizable material, which may be adapted to rotate to transmit power to a corresponding rotatable structure outside the sealed enclosure for directly or indirectly supplying power to the body engaging portion through the sealed enclosure.

[0157] According to one embodiment, the steerable implant may further comprise a corresponding rotatable structure outside the sealed enclosure for directly or indirectly powering the body engaging portion.

[0158] According to one embodiment, the maneuverable implant further comprises a reservoir for holding hydraulic fluid, the reservoir comprising a movable wall portion adapted to vary the volume of the reservoir, the movable wall portion may be directly or indirectly connected to a force output of a gear system whereby operation of the electric motor varies the volume of the reservoir via the gear system.

[0159] According to one embodiment, the device further comprises a corresponding rotatable structure outside the sealed enclosure, the corresponding rotatable structure being directly or indirectly connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force.

[0160] In any of the above embodiments, the threaded member may be directly or indirectly connected to the movable wall of the reservoir of embodiment 4 for varying the volume of the reservoir.

[0161] The steerable implant may further comprise a peristaltic pump, which may comprise a hollow member for transporting fluid and an operable compression member adapted to engage and compress the hollow member, wherein the force output of the gear system connects with the compression member via a magnetic coupler, whereby operation of the electric motor operates the compression member via the gear system such that fluid is transported into the hollow member.

[0162] According to one embodiment, the operating device further comprises a control unit for controlling at least one of the operating device and the body engagement portion, and the enclosure is adapted to surround the operating device comprising the control unit.

[0163] The operating device of the steerable implant further comprises at least one receiving unit adapted to receive wireless energy supplied from outside the patient's body, the receiving unit being located away from the operating device, and the enclosure being adapted to accommodate both the operating device and a distance element connecting the operating device and the receiving unit.

[0164] The distance element of the steerable implant is adapted to provide a distance between the wireless energy receiver and at least one of the electric motor and the magnetic coupler, such that the wireless energy receiver is substantially unaffected or not significantly affected by the metal and / or magnetic components of the electric motor and the magnetic coupler.

[0165] The receiving unit further comprises at least one coil adapted to convert the received wireless energy in the form of a magnetic, electric or electromagnetic field into electrical energy.

[0166] The electric motor of the steerable implant may be an axial-type electric motor comprising: a plurality of coils circularly distributed around the rotation axis of the electric motor, whereby the central axes of the coil spirals extend in the axial direction of the electric motor, parallel to the rotation axis of the electric motor; and magnets circularly distributed on a radially extending rotatable structure, whereby the magnets are circularly distributed around the rotation axis and face the coils in the axial direction, whereby the magnets at least partially radially overlap the coils, whereby sequential energization of the coils propels the magnets axially by magnetic force, causing rotation of the rotatable structure around the rotation axis of the electric motor.

[0167] In one embodiment, the electric motor is a radial electric motor comprising: a plurality of coils circularly distributed around the rotational axis of the implantable electric motor, whereby the central axes of the coil spirals extend radially about the implantable electric motor and generally perpendicular to the rotational axis of the motor; and a plurality of magnets circularly distributed on an axially extending rotatable structure, whereby the magnets are circularly distributed around the rotational axis and face the coils radially, whereby the magnets at least partially axially overlap the coils, whereby sequential energization of the coils propels the magnets by magnetic force, causing rotation of the rotatable structure about the rotational axis of the electric motor.

[0168] The electric motor in any of the above embodiments may be a linear electric motor: the coils are distributed linearly along the direction of motion of a moving part of the linear electric motor; the moving part comprises magnets distributed linearly along the direction of motion of the moving part, whereby sequential energization of the coils propels the magnets by magnetic force, generating linear motion of the moving part.

[0169] The electric motor of the operating device may be an alternating current (AC) electric motor, and the control unit may comprise a frequency converter for changing the frequency of the alternating current to control the alternating current electric motor.

[0170] According to one embodiment, the enclosure may comprise a material selected from: a carbon material; a boron material; a mixture of materials; a Peek® material; an alloy of materials; a metallic material; titanium; aluminum; a ceramic material; a polymeric material; polyurethane; polyetheretherketone; silicone; and Parylene® coated silicone.

[0171] The operating device may comprise a hydraulic pump for transporting hydraulic fluid from a reservoir to the hydraulically operable body engagement portion.

[0172] According to one embodiment, the electric motor comprises an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0173] The electric motor comprises: at least one reservoir having a wall moved by mechanical work acting as a pump; at least one reservoir whose volume changes to move a fluid acting as a pump; at least one valveless pump; at least one valve pump; at least one peristaltic pump; at least one membrane pump; at least one gear pump; and at least one bellows pump. The hydraulic pump may be adapted to drive an included hydraulic pump selected from:

[0174] According to one embodiment, the electric motor comprises: a set of coils circularly distributed around the rotation axis of the electric motor; and a set of magnets connected to a rotatable structure at least partially axially overlapping said coils, whereby sequential energization of said coils magnetically propels the magnets and causes the rotatable structure to rotate around the rotation axis. The second gear has a smaller diameter than the rotatable structure and is at least partially arranged in the same axial plane, whereby the rotatable structure at least partially overlaps with the second gear, whereby the gear system is at least partially arranged inside the electric motor.

[0175] According to one embodiment, the operable element is adapted to bias and maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear in at least one of one position, two positions, three positions, four or more positions, the two, three and four positions being angularly spaced positions separated by positions where the teeth do not interengage.

[0176] The operable element may be adapted to bias the first gear and maintain the first gear biased so that the teeth of the first gear interengage with the teeth of the second gear in at least two angularly spaced positions separated by a position where the teeth do not interengage.

[0177] The operating device may further comprise a second gear system comprising: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the operable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances the positions, thereby generating relative rotation between the first gear and the second gear. A first gear of the first gear system is directly or indirectly connected to an operable element of the second gear system, whereby the first gear system is connected in series with the second gear system, whereby the first gear system receives mechanical work having a first force and a first speed and outputs mechanical work having a second, different force and a second, different speed, and the second gear system receives the output mechanical work from the first gear system as an input and outputs mechanical work having a third, different force and a third, different speed.

[0178] The first gear system and the second gear system may be coaxially positioned along the rotational axes of the first gear system and the second gear system.

[0179] According to one embodiment, the second gear of at least one of the first and second gear systems has a smaller diameter than the rotatable structure and is at least partially arranged in the same axial plane, whereby the rotatable structure at least partially overlaps axially with the second gear of at least one of the first and second gear systems, whereby at least one of the first and second gear systems is at least partially arranged inside the electric motor.

[0180] The first gear and the second gear of the second gear system may have a larger diameter than the rotatable structure incorporated from embodiment 20 and may be at least partially arranged in the same axial plane, whereby the first gear and the second gear of the second gear system at least partially axially overlap with the rotatable structure, whereby the electric motor is at least partially arranged inside the second gear system.

[0181] The operable implant may further comprise a radially extending connecting structure that directly or indirectly connects the first gear of the first gear system to the operable element of the second gear system of embodiment 23 for transmitting force from the first gear system to the second gear system.

[0182] The first gear system may include a third gear, the inner side of which may include the same number of teeth as the outer side of the first gear, and the teeth of the third gear may be adapted to interengage with the teeth of the first gear, such that the third gear rotates along angularly spaced positions relative to the second gear.

[0183] A first gear of the first gear system may be adapted to be indirectly connected to an operable element of the second gear system via a third gear.

[0184] The rotatable structures in any of the above embodiments may be positioned radially inside or outside the circularly distributed coils.

[0185] The coil of the steerable implant may be adapted to remain surrounded during manipulation of the manipulation device.

[0186] According to one embodiment, at least one first gear of the first gear system and the second gear system is directly or indirectly connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, and the threaded member may be directly or indirectly connected to a movable wall portion of the reservoir.

[0187] The maneuverable implant may further comprise at least one fixation portion for fixing at least a portion of the maneuverable implant to at least one of the fibrosis, fascia and muscle layer toward the interior of the patient's subcutaneous space.

[0188] According to one embodiment, the first reservoir is in fluid communication with the hydraulically operable body engagement portion, and the operating device is adapted to: cause transport of fluid from the first reservoir to the hydraulically operable body engagement portion.

[0189] A portion of the wall of the reservoir may have at least one of: a bellows structure; a shape adapted to allow movement even when covered by fibrosis; and a plate-like surface, in all cases allowing movement of at least one movable wall portion and allowing compression and / or expansion of the reservoir.

[0190] Further provided is a maneuverable implant that may comprise an operating device and a body-engaging portion, the operating device comprising: an electric motor having a force output; and a starting resistance delay member positioned between the force output of the electric motor and the body-engaging portion, the starting resistance delay member adapted to enable the electric motor to be operated by at least one of a weak force or a weak frictional force induced by direct or indirect connection with the body-engaging portion for a period of time, thereby allowing the electric motor to be started even with a weak resistance force.

[0191] According to one embodiment, the force output of the electric motor may be directly or indirectly connected to the force input of a gear system. The gear system may comprise: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the operable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first gear and the second gear, and the gear system comprises a force output connected to the first gear.

[0192] In any of the above embodiments, the manipulable implant further comprises a second gear system positioned between the first gear system and the initiation resistance delay. The second gear system may comprise: a force input connected to a manipulable element directly or indirectly connected to a force output of the first gear system; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the manipulable element is adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and wherein operation of the manipulable element advances the positions thereby generating relative rotation between the first gear and the second gear, and the second gear system comprises a force output connected to the first gear of the second gear system.

[0193] The initiation resistance delay member may be positioned between the force output of the electric motor and the force input of the gear system, or between the force output of the gear system and the body engaging portion.

[0194] In an alternative embodiment, the initiation resistance delay member is positioned one of: between the force output of the first gear system and the force input of the second gear system; and between the force output of the second gear system and the body engaging portion.

[0195] According to one embodiment, the initiation resistance delay member comprises a spring, which may be a helical spring or a leaf spring.

[0196] In an alternative embodiment, the initiation resistance delay member includes mechanical play, which may be one of: radial mechanical play and linear mechanical play.

[0197] The start resistance delay member may include radial mechanical play that allows the force output of the electric motor to perform at least one of 1 / 10 rotational speed, 1 / 8 rotational speed, 1 / 6 rotational speed, 1 / 4 rotational speed, 1 / 2 rotational speed, and 1 rotational speed before the force output directly or indirectly engages the drive member.

[0198] According to one embodiment, the initiation resistance delay member is positioned between at least one of: between the force output of the first gear system and the force input of the second gear system; and between the force output of the second gear system and the body engagement portion. The initiation resistance delay member may include radial mechanical play that allows the force output of the gear system to achieve at least one of 1 / 10 RPM, 1 / 8 RPM, 1 / 6 RPM, 1 / 4 RPM, 1 / 2 RPM, and 1 RPM before the force output engages the drive member, thereby allowing the force output of the electric motor to achieve at least one of 1 / 10 RPM* gear system transmission, 1 / 8 RPM* gear system transmission, 1 / 6 RPM* gear system transmission, 1 / 4 RPM* gear system transmission, 1 / 2 RPM* gear system transmission, and 1 RPM* gear system transmission.

[0199] In an alternative embodiment, the starting resistance delay device may comprise a friction clutch.

[0200] In a further alternative embodiment, the initiation resistance delay device may comprise at least one element adapted to be operated by centrifugal force, said at least one element may be connected to an electric motor and adapted to directly or indirectly engage with the body engaging portion when the centrifugal force on the element exceeds the centrifugal delay force.

[0201] According to one embodiment, the operable element of the first and / or second gear system may comprise an element adapted to be operated by centrifugal force, whereby the operable element of the gear system engages with the first gear when the centrifugal force acting on the element exceeds the centrifugal retarding force.

[0202] The electric motor may be an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0203] According to one embodiment, the body engagement portion is a hydraulically operable body engagement portion connected to a hydraulic pump that delivers hydraulic fluid to operate the hydraulically operable body engagement portion. The hydraulic pump may comprise a reservoir having at least one movable wall portion, said at least one movable wall portion may be directly or indirectly connected to an electric motor, whereby the electric motor is arranged to operate the movable wall portion to vary the volume of the reservoir.

[0204] According to one embodiment, the force output of the electric motor is directly or indirectly connected to a threaded member adapted to convert the radial rotational force of the electric motor into an axial reciprocating force, and the threaded member may be directly or indirectly connected to a movable wall portion of the reservoir for varying the volume of the reservoir.

[0205] According to one embodiment of the maneuverable implant, the threaded member is directly or indirectly connected to a movable wall portion of the second reservoir for varying the volume of the second reservoir.

[0206] Movement of the movable wall portion of the first reservoir in a first direction by the threaded member may cause the first fluid reservoir to expand, increasing the volume of the first reservoir, while movement of the movable wall portion of the second reservoir in a first direction by the threaded member causes the second reservoir to contract, decreasing the volume of the second reservoir.

[0207] According to one embodiment, the first reservoir is in fluid communication with a first hydraulically operable body engaging portion and the second reservoir is in fluid communication with a second hydraulically operable body engaging portion. Operation of the electric motor in a first direction via connection with the threaded member causes: fluid to be transported from the first reservoir to the first hydraulically operable implant and fluid to be transported from the second hydraulically operable body engaging portion to the second fluid reservoir.

[0208] The reservoir may be, for example, circular or donut-shaped. According to one embodiment of the manipulable implant, the manipulable implant comprises a circular reservoir surrounding the manipulation device. The circular reservoir comprises a movable wall portion adapted to compress and expand the circular reservoir, thereby varying the volume of the reservoir, the movable wall portion being connected to an electric motor, whereby operation of the electric motor varies the volume of the circular reservoir.

[0209] A portion of the wall of the reservoir may have at least one of: a bellows structure; a shape adapted to allow movement even when covered by fibrosis; and a plate-like surface, in all cases allowing movement of at least one movable wall portion and allowing compression and / or expansion of the reservoir.

[0210] In one embodiment, the operable implant comprises a hydraulic pump, which may comprise a peristaltic pump comprising: a fluid transporting hollow member; and an operable compression member adapted to engage and compress the hollow member, wherein an electric motor is directly or indirectly connected to the compression member, whereby operation of the electric motor operates the compression member such that fluid is transported into the hollow member.

[0211] The present invention also provides a manipulable implant adapted for implantation in a patient's body. The manipulable implant includes a manipulation device and a body-engaging portion. The manipulation device includes a manipulable element and a first gear system including a hollow cylindrical first gear having a first number of teeth on its outer circumference and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The manipulable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage. Manipulation of the manipulable element advances the interengaged position, thereby generating relative rotation between the first gear and the second gear. The operating device further comprises: a manipulable element, a second gear system comprising a hollow cylindrical first gear having a first number of teeth on its outer circumference, and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The manipulable element is adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage. Manipulation of the manipulable element advances the at least one position, thereby generating relative rotation between the first gear and the second gear.

[0212] A first gear of the first gear system is directly or indirectly connected to an operable element of the second gear system such that the first and second gear systems function as a single gear system.

[0213] According to one embodiment, a first gear of the first and second gear systems includes a deflectable wall. The operable element is adapted to deflect and maintain the first gear deflected so that teeth of the first gear interengage with teeth of the second gear at at least one angularly spaced apart position separated by a position where the teeth do not interengage. Operation of the pushing element rotationally advances the angularly spaced apart positions, thereby generating relative rotation between the first gear and the second gear.

[0214] According to one embodiment, the operable element is adapted to bias the first gear and to maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear in at least one of at least two angularly spaced positions and at least three angularly spaced positions separated by positions where the teeth do not interengage.

[0215] In one embodiment of the steerable implant, at least one of the first and second gear systems comprises a hollow cylindrical third gear, the inside of which has the same number of teeth as the outside of the first gear, the teeth of the third gear adapted to interengage with the teeth of the first gear, thereby rotating the third gear relative to the second gear along at least one interengaging position.

[0216] In one embodiment of the steerable implant, the first gear system comprises a hollow cylindrical third gear, the inside of which has the same number of teeth as the outside of the first gear of the first gear system, the teeth of the third gear adapted to interengage with the teeth of the first gear, thereby rotating the third gear relative to the second gear along at least one interengaging position, and the steerable element of the second gear system is directly or indirectly connected to the third gear of the first gear system.

[0217] The first gear system may be at least partially positioned radially inside the second gear system, such that the second gear system at least partially overlaps the first gear system axially. In an alternative embodiment, the first and second gear systems may be positioned coaxially along the axes of rotation of the first and second gear systems.

[0218] According to one embodiment, the maneuverable implant further comprises a radially extending connecting structure that directly or indirectly connects a first gear of the first gear system to a maneuverable element of the second gear system for transmitting forces from the first gear system to the second gear system.

[0219] The implant may further comprise an enclosure adapted to sealingly surround the first and second gear systems such that the first and second gear systems are sealed from body fluids when implanted.

[0220] The operable elements of the first and second gear systems of any of the above embodiments may further comprise at least one of: planetary gears, and structures or wheels with friction surface connections.

[0221] In one embodiment, the steerable implant further comprises an electric motor, which may include an electric motor selected from: an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a piezoelectric motor, a three-phase motor, a two or more phase motor, a bimetallic motor, and a shape memory metal motor.

[0222] The steerable implant of any of the above embodiments may further comprise an enclosure adapted to hermetically enclose the first gear system and the electric motor, and the enclosure may further comprise a sealed output for rotational power such that power is transmitted from the hermetically enclosed first gear system to the second gear system.

[0223] The steerable implant in any of the above embodiments may further comprise a system enclosure adapted to sealingly enclose the first gear system, the second gear system and the electric motor.

[0224] The steerable implant may further comprise a sealed output for rotational force such that force is transmitted to the steerable implant from a hermetically enclosed second gear system.

[0225] The operable implant may further comprise an enclosure adapted to hermetically enclose the electric motor, and the enclosure may further comprise a sealed output for rotational power such that power is transmitted from the hermetically enclosed motor to the first gear system.

[0226] The steerable implant may further comprise an enclosure adapted to hermetically surround a stationary portion of the electric motor comprising at least one of: the at least two coils; and the at least one coil.

[0227] According to one embodiment, the enclosure of the stationary portion of the motor may comprise a wall, and the manipulable implant may be adapted to wirelessly generate a rotational force from the hermetically enclosed stationary portion via the sealed wall to generate a rotational force that rotates a rotor portion of the motor comprising at least one of at least one magnet, a magnetizable material and at least one coil, the rotor being adapted to be further connected directly or indirectly to the first gear system.

[0228] According to one embodiment, the operable implant further comprises an enclosure adapted to sealingly surround the rotor portion of the electric motor and at least one of the first gear system and the first and second gear systems.

[0229] The present invention also provides a maneuverable implant adapted to be implanted in a patient's body, the maneuverable implant comprising a maneuvering device and a body-engaging portion. The maneuvering device comprises: at least one of at least one magnet, at least one magnetic material, and at least one magnetizable material adapted to be affected by a movable magnetic field formed by the external unit upon implantation, such that the magnet or magnetic or magnetizable material can move along the movable magnetic field of the external unit. The maneuvering device further comprises: a maneuverable element directly or indirectly connected to the at least one magnet, magnetic material, or magnetizable material so as to be driven by the magnet or magnetic material moving along the movable magnetic field of the external unit; and a gear system comprising: a first gear having a hollow cylindrical shape with a first number of teeth on its outer circumference; and a second gear having a hollow cylindrical shape with a greater number of teeth on its inner surface than the first gear. The manipulable element is adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the manipulable element advances said positions, thereby generating relative rotation between the first and second gears.

[0230] The manipulation device of any of the above embodiments may be adapted to be implanted subcutaneously, which may be in the abdominal region.

[0231] In any of the above embodiments, the operating device may include a first unit and a second unit, with at least one magnet, magnetic material, or magnetizable material being located in the first unit and the gear system being located in the second unit.

[0232] The maneuverable implant may further include a distance element adapted to provide a distance between the first and second units. The distance element is adapted for placement through the muscle layer of the abdominal wall and / or fixation to fascia inside the subcutaneous space. The distance element may be flexible, allowing the first and second units to move relative to each other. The distance element may be adapted for fixation to at least one of the fascia and muscle layer of the abdominal wall, thereby controlling the distance between the first portion of the manipulation device and the patient's skin. The distance element may include a mechanical transmission member adapted to transmit force from the first unit to the second unit, whereby force is transmitted from at least one magnet, magnetic material, or magnetizable material to the maneuverable element of the gear system.

[0233] In one embodiment, the maneuverable implant further comprises an enclosure adapted to sealingly surround at least one of the maneuverable implant, the maneuvering device, the body engaging portion, the first unit, the second unit and the distance element; to seal from the patient's bodily fluids.

[0234] In one embodiment, the enclosure constitutes a reservoir for supplying fluid to a hydraulically operable body engaging portion, whereby at least one magnet, magnetic or magnetizable material and gear system are located inside the reservoir.

[0235] The operable implant further comprises a reservoir having a movable wall portion adapted to vary the volume of the reservoir, the movable wall portion being directly or indirectly connected to a first gear of the gear system, whereby operation of the gear system varies the volume of the reservoir.

[0236] The first gear of the gear system may be directly or indirectly connected to a threaded member adapted to convert a rotational force into a reciprocating force.

[0237] The threaded member may be directly or indirectly connected to a movable wall portion of the reservoir for varying the volume of the reservoir.

[0238] The steerable implant may further comprise a peristaltic pump comprising a hollow member for transporting fluid and an operable compression member adapted to engage and compress the hollow member, wherein a first gear of the gear system is directly or indirectly connected to the compression member, whereby operation of the gear system operates the compression member such that fluid is transported into the hollow member.

[0239] The maneuverable implant in any of the above embodiments may further comprise a second gear system comprising: a maneuverable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The maneuverable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at least one position separated by a position where the teeth do not interengage, and manipulation of the maneuverable element causes relative rotation between the first gear and the second gear by advancing at least one position, and the first gear of the first gear system is directly or indirectly connected to the maneuverable element of the second gear system, whereby the first and second gear systems function as a single gear system.

[0240] The operable element of one of the first and second gear systems may include at least one of a planetary gear and a structure or wheel that uses friction at least in part to enable rotational force to be transported.

[0241] The operable implant in any of the above embodiments may further comprise a wireless communication unit adapted for at least one of: receiving wireless communication signals from an external unit; and transmitting wireless communication signals to an external unit.

[0242] Further provided is an external unit for supplying a force to the implanted manipulation device, the external unit comprising: an external drive unit adapted to generate a moving magnetic field outside the patient's skin adapted to influence at least one magnet or magnetic or magnetizable material of the implanted manipulation device, whereby the magnet or magnetic material moves along the moving magnetic field of the external drive unit.

[0243] The external drive unit may further comprise a set of coils circularly distributed around the axis of rotation of the external unit, whereby sequential energization of the coils creates a rotating magnetic field adapted to influence magnets or magnetic or magnetizable material of the implanted operating device, causing the magnets or magnetic material to move along the moving magnetic field of the external drive unit.

[0244] The external device unit may further comprise a rotating structure comprising at least one magnet or magnetic material, and rotation of the rotatable structure may affect and rotate the magnet or magnetic material or magnetizable material of the embedded operating device, thereby causing the magnet or magnetic material or magnetizable material to rotate along with the rotatable structure of the external unit.

[0245] According to one embodiment, the external unit further comprises a wireless communication unit adapted for at least one of: receiving wireless communication signals from the implantable unit; and transmitting wireless communication signals to the implantable unit.

[0246] There is also provided a medical system, the medical device comprising: an operable implant according to any one of the preceding embodiments; and an external unit according to any one of the preceding embodiments.

[0247] In one of the above embodiments, the operating device comprises a rotatable structure adapted to hold at least one of at least one magnet, at least one magnetic material, and at least one magnetizable material, and further adapted to be influenced by an externally generated movable magnetic field, whereby the rotatable structure rotates.

[0248] The operable implant may further comprise an enclosure adapted to sealingly surround at least one of the rotatable structure according to any of the above embodiments, the reservoir according to any of the above embodiments, and the threaded member according to any of the above embodiments, to seal it from the patient's bodily fluids.

[0249] In any of the above embodiments, the operating device may include a reservoir adapted to contain hydraulic fluid and at least one movable wall portion for changing the volume of the reservoir. The operating device is adapted to operate the movable wall of the reservoir, and the operating device includes a gear system disposed within the reservoir, the gear system including: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, the operable element being adapted to engage with the inside of the first gear such that the outside of the first gear is pressed against the inside of the second gear such that the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances the position, thereby generating relative rotation between the first gear and the second gear.

[0250] There is also provided an operable implant adapted for implantation in a patient's body, the operable implant comprising a hydraulic actuation device for supplying hydraulic force and a body engaging portion adapted to receive hydraulic force, the hydraulic actuation device comprising: a reservoir adapted to contain hydraulic fluid and having at least one movable wall portion to vary a volume of the reservoir, and an actuation device adapted to operate the movable wall and comprising a gear system disposed within the reservoir. The gear system comprises: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, the operable element being adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first gear and the second gear.

[0251] The first gear of the steerable implant connects directly or indirectly to a threaded member adapted to convert a rotational force into a reciprocating force.

[0252] The threaded member may be directly or indirectly connected to a movable wall portion of the reservoir, whereby operation of the operating device varies the volume of the reservoir.

[0253] The operable implant according to any one of the above embodiments further comprises a rotatable structure disposed inside the reservoir and connected to the operable element of the gear system, the rotatable structure comprising at least one magnet, at least one magnetic material, or at least one magnetizable material adapted to be magnetically coupled with a rotating magnetic field outside the reservoir, whereby the rotating magnetic field outside the reservoir propels the rotatable structure inside the reservoir.

[0254] The rotatable structure of the steerable implant may comprise a radially extending disk comprising a plurality of magnets, the plurality of magnets adapted to be axially magnetically coupled to a rotating magnetic field.

[0255] According to one embodiment, the maneuverable implant further comprises a drive unit comprising a plurality of coils circularly distributed and axially positioned around the axis of rotation of a rotatable structure positioned inside the reservoir, whereby the central axes of the coil helices extend axially and are substantially parallel to or substantially centered on the center of the axis of rotation of the rotatable structure, and sequential energization of the coils creates a rotating magnetic field that propels the rotatable structure axially.

[0256] The steerable implant may further comprise a magnetic coupler comprising a drive rotatable structure comprising a plurality of magnets distributed circularly around the axis of rotation of the rotatable structure, which may be adapted to magnetically couple with a rotatable structure positioned inside the reservoir, and which connects to an electric motor adapted to propel the drive rotatable structure, such that the rotatable structure positioned inside the reservoir rotates along with the drive rotatable structure.

[0257] The rotatable structure may comprise an axially extending cylinder with a plurality of magnets positioned on a peripheral surface of the cylinder, the plurality of magnets adapted to be radially magnetically coupled to a rotating magnetic field.

[0258] The maneuverable implant may further comprise a drive unit comprising a plurality of coils positioned radially and distributed circularly around the axis of rotation of a rotatable structure positioned inside the reservoir, whereby the central axes of the coil helices extend radially and are substantially parallel to the axis of rotation of the rotatable structure, and sequential energization of the coils creates a rotating magnetic field that propels the rotatable structure.

[0259] The steerable implant may further comprise a drive unit comprising a drive rotatable structure comprising a plurality of magnets distributed circularly around the axis of rotation of the rotatable structure. The drive rotatable structure may be adapted to radially magnetically couple with a rotatable structure positioned inside the reservoir. The drive rotatable structure may be connected to an electric motor adapted to propel the drive rotatable structure, whereby the rotatable structure positioned inside the reservoir rotates along with the drive rotatable structure adapted to rotate radially outwardly thereof.

[0260] According to one embodiment, the drive unit is an external drive unit positioned external to the patient's skin and adapted to propel a rotatable structure within the hydraulically actuated device.

[0261] According to one embodiment, the hydraulic actuation device comprises an electric motor adapted to propel an actuable element of a gear system, which may be an electric motor selected from: an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a radial motor, a three-phase motor, a two or more phase motor, a piezoelectric motor, a bimetallic motor, and a shape memory metal motor.

[0262] The electric motor may be adapted to be positioned inside the reservoir.

[0263] An operable implant according to any one of the above embodiments may further comprise a power transmission member adapted for at least one of: penetrating the wall of the fluid reservoir, not penetrating the wall of the reservoir, transmitting force from outside the reservoir to inside the reservoir, and transmitting force between a motor and a gear system inside the reservoir.

[0264] The power transmission member may be connected to the implantable electric motor and the operable element of the gear system and may be adapted to transmit rotational power from the electric motor to the operable element.

[0265] The manipulable implant may further comprise a second gear system comprising: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the manipulable element is adapted to engage the inside of the first gear such that the outside of the first gear is pressed against the inside of the second gear such that the teeth of the first gear interengage with the teeth of the second gear at least one position separated by a position where the teeth do not interengage, and manipulation of the manipulable element causes relative rotation between the first and second gears by advancing at least one position. The first gear of the first gear system may be connected to the manipulable element of the second gear system, such that the first and second gear systems function as a single gear system.

[0266] According to one embodiment, the operable element of at least one of the first and second gear systems comprises at least one of: a planetary gear, and a wheel or structure adapted to utilize a direct or indirect frictional connection between the operable element and the first gear.

[0267] The hydraulic operating device further comprises at least one receiving unit adapted to receive wireless energy supplied from outside the patient's body.

[0268] The receiving unit of the steerable implant comprises at least one coil adapted to convert the received wireless energy in the form of a magnetic or electromagnetic field into electrical energy.

[0269] The steerable implant may further comprise a distance element adapted to provide a distance between the receiving unit and at least one of the reservoir and the electric motor, such that the receiving unit remains substantially unaffected by metallic and / or magnetic components of the reservoir and / or the electric motor. The distance element is adapted for either placement through the muscle layer of the abdominal wall and fixation to the fascia of the muscle facing the interior of the subcutaneous space.

[0270] According to one embodiment, the distance element is flexible, allowing the wireless energy reservoir to move relative to the reservoir and / or the electric motor. The distance element may be adapted to be anchored to at least one muscle layer of the abdominal wall, allowing the distance between the first portion of the implantable unit and the patient's skin to be controlled, or minimizing movement, including rotation, of the distance element, or both.

[0271] The steerable implant may further comprise an inlet for supplying fluid directly or indirectly to a reservoir or hydraulically operated steerable implant.

[0272] There is also provided an implantable generator for converting mechanical work into electrical energy, the implantable generator comprising: a movable structure comprising at least one magnet, at least one magnetic material, or at least one magnetizable material, adapted to be magnetically coupled to an external drive unit that generates a movable magnetic field, thereby moving along the movable magnetic field, the implantable generator further comprising a generator unit connected to the movable structure and adapted to convert the motion of the movable structure into electrical energy.

[0273] The generator unit comprises: a movable generating part having at least one magnet and connected to the movable structure, and at least one coil in magnetic communication with the at least one magnet, wherein movement of the movable generating part relative to the coil induces a current in the coil.

[0274] According to one embodiment, the movable structure comprises a rotatable disk, and at least one magnet or magnetic material is positioned on the rotatable disk and adapted to be magnetically coupled with an external unit that forms a rotating magnetic field, and the power generating unit is a rotating power generating unit connected to the rotatable disk, whereby the rotating power generating unit rotates along with or is part of the rotatable disk to induce an electric current.

[0275] The movable structure is adapted to undergo reciprocating motion and is adapted to magnetically couple with an external unit to create a reciprocating magnetic field, thereby undergoing reciprocating motion along the reciprocating magnetic field.

[0276] According to one embodiment, the movable structure is connected to a resilient element or spring, whereby the movable structure can be manipulated in a first direction by a magnetic force supplied by an external unit and in a second direction by the resilient element or spring.

[0277] The resilient element may comprise at least one of: an elastic material, a flexible material, a structure adapted to produce resilient movement, and a spring.

[0278] In one embodiment, the power generating unit may be a linear power generating unit, comprising: a movable power generating portion coupled to a movable structure comprising at least one magnet and adapted to undergo reciprocating motion; and at least one coil magnetically coupled to the at least one magnet, whereby the reciprocating motion of the movable structure is transmitted to the movable power generating portion and which induces a current in the at least one coil.

[0279] According to one embodiment, the implantable generator further comprises a battery connected to the power generation unit, the battery adapted to store the electrical energy generated by the power generation unit.

[0280] The implantable generator may further comprise an enclosure adapted to hermetically surround the implantable generator, thereby sealing the implantable generator from the patient's body fluids.

[0281] The implantable generator may further comprise a wireless communication unit adapted to do at least one of: receive wireless communication signals from an external unit; and transmit wireless communication signals to an external unit.

[0282] The implantable generator may be adapted for subcutaneous implantation, which may be subcutaneously within the abdomen.

[0283] There is also provided an external unit for supplying power to the implantable generator, the external unit comprising an external drive unit adapted to generate a moving magnetic field external to the patient's skin adapted to influence at least one magnet, at least one magnetic material, or at least one magnetizable material of the implantable generator, such that the magnet or magnetic material moves along the moving magnetic field of the external drive unit.

[0284] According to one embodiment, the external drive unit comprises at least one electromagnet adapted to be alternately energized and de-energized, thereby creating an alternating magnetic field to influence the magnet or magnetic material of at least one of the implantable generators.

[0285] The external drive unit may comprise at least one permanent magnet, a positive pole of the permanent magnet adapted to influence the permanent magnet of the implantable generator, and a negative pole of the permanent magnet adapted to influence the permanent magnet of the implantable generator, and the at least one permanent magnet may be adapted to move so that the positive and negative poles alternately influence the permanent magnet of the implantable generator.

[0286] According to one embodiment, the external drive unit comprises a set of circularly distributed coils, whereby sequential energization of the coils creates a rotating magnetic field adapted to influence the magnet, magnetic material or magnetizable material of the implantable generator, causing the magnet, magnetic material or magnetizable material to rotate along the rotating magnetic field of the external drive unit.

[0287] In one embodiment, the external unit comprises a set of linearly distributed coils, whereby sequential energization of the coils creates a linear moving magnetic field adapted to influence the magnet or magnetic or magnetizable material of the implantable generator, causing the magnet, magnetic or magnetizable material to move along the linear magnetic field of the external unit.

[0288] The external unit may comprise a rotatable structure comprising at least one magnet or magnetic material, and rotation of the rotatable structure may affect the magnet or magnetic material of the implantable generator causing it to rotate, thereby causing the magnet or magnetic material to rotate along with the rotatable structure of the external unit.

[0289] The external drive unit may comprise a reciprocating structure comprising at least one of a magnetic material, a permanent magnet, and an electromagnet, the reciprocating structure being adapted to: a) move the magnetic material, permanent magnet, or electromagnet between a first portion proximate to the patient's skin and a second portion remote from the patient's skin, thereby creating a reciprocating magnetic field adapted to influence the magnet or magnetic material of the implantable generator; or b) intermittently receive electrical pulses to the at least one electromagnet while the reciprocating structure is substantially stationary, thereby generating a movement of the magnetic field.

[0290] According to one embodiment, the external unit further comprises a wireless communication unit adapted to perform at least one of: receiving wireless communication signals from the implantable generator; and transmitting wireless communication signals to the implantable generator.

[0291] There is also provided a system for generating an electric current inside a patient's body, the system comprising: an implantable generator according to any one of the previous embodiments, and an external unit according to any one of the previous embodiments.

[0292] There is also provided an operable hydraulic implant comprising a hydraulic actuation device comprising: a reservoir adapted to contain hydraulic fluid for actuating the operable hydraulic implant; and an enclosure adapted to sealingly enclose a gear system adapted to receive mechanical work of a first force and velocity as an input and to output mechanical work having a different force and velocity, wherein the reservoir and gear system are sealed from body fluids upon implantation.

[0293] The reservoir may comprise at least one movable wall portion for varying the volume of the reservoir.

[0294] In one embodiment, a gear system connects to the movable wall for varying the volume of the reservoir.In one embodiment, the operable hydraulic implant further comprises an electric motor connected to the gear system and enclosed in the enclosure.

[0295] In one of the above embodiments, the gear system comprises: an operable element, a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the operable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said position, thereby generating relative rotation between the first gear and the second gear.

[0296] In one embodiment of the manipulable hydraulic implant, the manipulable element of the gear system is adapted to receive mechanical work from the electric motor at a first force and speed, and a first gear of the gear system is directly or indirectly connected to at least one movable wall portion for providing mechanical work having a different second force and speed to the at least one wall portion, whereby operation of the electric motor moves the movable wall portion and changes the volume of the reservoir.

[0297] In one embodiment, a first gear of the gear system connects directly or indirectly to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, and the threaded member connects directly or indirectly to a movable wall portion for varying the volume of the reservoir. In one embodiment, the threaded member may connect directly or indirectly to a movable wall portion of a second fluid reservoir for varying the volume of the second reservoir.

[0298] Movement of the movable wall portion of the first reservoir, by the threaded member in the first direction, causes the first reservoir to expand, increasing the volume of the first reservoir, and movement of the movable wall portion of the second reservoir, by the threaded member in the first direction, causes the second reservoir to contract, decreasing the volume of the second reservoir.

[0299] The first reservoir may be in fluid communication with a first hydraulically operable body engaging portion and the second reservoir may be in fluid communication with a second hydraulically operable body engaging portion, and operation of the electric motor unit in a first direction may be by connection with a threaded member to: transport fluid from the first reservoir to the first hydraulically operable body engaging portion, and transport fluid from the second hydraulically operable body engaging portion to the second reservoir.

[0300] According to one embodiment of the manipulable hydraulic implant, the walls of the enclosure constitute at least a portion of the walls of the reservoir, and at least one movable wall portion may be positioned between the reservoir and the gear system, whereby a portion of the at least one movable wall portion separates the reservoir from a portion of the enclosure surrounding the gear system, thereby sealing the gear system from the reservoir.

[0301] The operable hydraulic implant further comprises a second gear system surrounded by the enclosure, the second gear system adapted to receive mechanical work of a different second force and velocity from the output of the first gear system and to output mechanical work having a different third force and velocity.

[0302] The second gear system comprises: an operable element, a first gear having a hollow cylindrical shape with a first number of teeth on its outer circumference, and a second gear having a hollow cylindrical shape with a greater number of teeth on its inner surface than the first gear, the operable element being adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, operation of the operable element causes relative rotation between the first gear and the second gear by advancing said positions, and the first gear of the first gear system is directly or indirectly connected to the operable element of the second gear system, whereby the first and second gear systems function as a single gear system.

[0303] According to one embodiment, the operable element of at least one of the first and second gear systems may comprise at least one of: a planetary gear, and a wheel or structure utilizing a frictional connection.

[0304] The operable hydraulic implant may further comprise at least one battery enclosed in the enclosure and adapted to power the electric motor.

[0305] According to one embodiment, the steerable hydraulic implant further comprises a receiving unit adapted to receive wireless energy transmitted from outside the patient's body.

[0306] The receiving unit is adapted to be surrounded by an enclosure, which seals the receiving unit from body fluids.

[0307] The operable hydraulic implant may further comprise a distance element adapted to provide a distance between the receiving unit and at least one of the gear system and the electric motor, thereby separating the receiving unit from metal and / or magnetic parts of the gear system and / or the electric motor.

[0308] The receiving unit may be adapted to charge a battery according to any one of the above embodiments.

[0309] In one embodiment, the operable hydraulic implant further comprises a magnetic coupler, the magnetic coupler being connected to the operable element of the gear system and comprising a first portion surrounded by an enclosure, the second portion being: positioned outside the enclosure and connected to an electric motor positioned such that operation of the electric motor operates the second portion of the magnetic coupler, the first portion of the magnetic coupler rotating along the second portion of the magnetic coupler, thereby causing the electric motor to magnetically connect to the first portion of the magnetic coupler so as to propel the gear system through the wall of the enclosure.

[0310] According to one embodiment, the maneuverable hydraulic implant may further comprise an implanted electric motor, and the second portion may be connected to the implantable electric motor. The second portion of the magnetic coupler may be connected to an external drive unit adapted to propel the first unit from outside the patient's body.

[0311] The electric motor may be an electric motor selected from: an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a radial motor, a three-phase motor, a two or more phase motor, a piezoelectric motor, a bimetallic motor, and a shape memory metal motor.

[0312] The enclosure of the implantable hydraulic unit may comprise a material selected from: a carbon material; a boron material; a mixture of materials; a Peek® material; an alloy of materials; a metallic material; titanium; aluminum; a ceramic material; a polymeric material; polyurethane; polyetheretherketone; silicone; and Parylene® coated silicone.

[0313] A steerable implant for implantation in a patient's body is provided, comprising at least one fixation member adapted to directly or indirectly fix the steerable implant to at least one of at least one fascia, at least one osteofascia, at least one cortical bone layer, at least one muscle layer, fibrous tissue, any portion of the abdominal wall, any portion of the subcutaneous space, and surrounding areas within the body, and at least one adjustable distance element connected at one end directly or indirectly to at least a portion of the steerable implant and connected at its other end directly or indirectly to the fixation member, the adjustable distance element adapted to adjust the distance between the fixation member and the portion of the steerable implant connected to the adjustable distance element.

[0314] The steerable implant may comprise at least one part selected from the following list: a manipulation device; a control unit; a receiving unit for receiving wireless energy; a coil for receiving wireless energy; a receiving unit for receiving a magnetic or electromagnetic field; a magnetic force transmission coupler; an electrical circuit; a push button for controlling functions of the maneuverable implant; an energy storage device; a depressible structure for adjusting the adjustable distance element; an integrated manipulation device and receiving unit for receiving wireless energy, a magnetic or electromagnetic field adapted to generate kinetic energy; a case for enclosing at least one of the different parts of the maneuverable implant; two or more cases for enclosing at least one of the different parts of the maneuverable implant within each case. The at least one adjustable distance element may be adapted to adjust the distance between the fixation member and at least one of the above-mentioned parts.

[0315] According to one embodiment of the steerable implant, the at least one fixation member is integrated with at least one of: a manipulation device; a control unit; a receiving unit for receiving wireless energy; a coil for receiving wireless energy; a receiving unit for receiving a magnetic or electromagnetic field; a magnetic force transmission coupler; an electrical circuit; a push button for controlling functions of the steerable implant; an energy storage device; a depressible structure for adjusting an adjustable distance element; an integrated manipulation device and receiving unit for receiving wireless energy, a magnetic or electromagnetic field adapted to generate kinetic energy; a case for enclosing at least one different portion of the steerable implant; two or more cases for enclosing at least one different portion of the steerable implant within each case; or an integrated unit comprising two or more of the above components. The at least one adjustable distance element is adapted to adjust the distance between a fixation member integrated with one or more components of the steerable implant and the one or more components of the steerable implant.

[0316] According to one embodiment, the at least one adjustable distance element is adjustable from outside the patient's body.

[0317] According to one embodiment, the at least one adjustable distance element is electrically or manually adjustable from outside the patient's body, and may comprise two, three, four, or more adjustable distance elements.

[0318] According to one embodiment, the at least one adjustable distance element comprises a threaded member for converting rotary motion into linear motion to adjust the distance.

[0319] At least one adjustable distance element or maneuverable implant may comprise an X-ray detectable element, whereby the distance adjusted by the at least one adjustable distance element can be measured by X-ray imaging, and / or at least one adjustable distance element or maneuverable implant may comprise an ultrasound detectable element, whereby the distance adjusted by the at least one adjustable distance element can be measured by ultrasound.

[0320] At least one part of the steerable implant may be adapted for subcutaneous placement and / or the manipulation device may be adapted for subcutaneous placement.

[0321] The manipulation device of the steerable implant may be adapted to be secured to at least one of the at least one fascial layer and the at least one muscle layer of the abdominal wall.

[0322] The at least one adjustable distancing element may be adapted to be positioned through at least one of the at least one fascial layer and the at least one muscle layer of the abdominal wall.

[0323] At least one adjustable distance element in any of the above embodiments may be flexible to allow different parts of the steerable implant to flex relative to one another.

[0324] In one embodiment, the receiving unit comprises at least one coil adapted to convert received wireless energy in the form of an electric, magnetic or electromagnetic field into electrical energy, or the receiving unit comprises a first coil having at least a first number of turns and a second coil having at least a second, different number of turns.

[0325] The steerable implant may further comprise at least one enclosure adapted to sealingly enclose at least one part of the steerable implant and / or the adjustable distance element.

[0326] At least one adjustable distance element in any of the above embodiments may comprise a conductor for transmitting electrical current from the receiving unit to the operating device.

[0327] The steerable implant may further comprise a control unit for controlling at least one parameter of the steerable implant, and the control unit may be adapted for wireless communication with the external unit, thereby allowing the control unit to be controlled wirelessly from outside the body.

[0328] According to one embodiment, the described receiving unit and at least one of the at least one adjustable distance element may be free of magnetic components.

[0329] The at least one enclosure in any of the above embodiments may comprise two or more enclosures, and the at least one adjustable distance element may be adapted to adjust the distance between the enclosures.

[0330] Further provided is a surgical kit for a maneuverable implant that allows for an adjustable distance between at least one fixation member of the maneuverable implant and at least one component of the maneuverable implant, the surgical kit comprising: at least one first distance element comprising a first connecting portion adapted to connect, directly or indirectly, to at least a portion of the maneuverable implant and a second connecting portion adapted to connect, directly or indirectly, to at least one fixation member of the maneuverable implant to provide a first distance between at least a portion of the maneuverable implant and at least one fixation member of the maneuverable implant; and at least one second distance element comprising a first connecting portion adapted to connect, directly or indirectly, to at least a portion of the maneuverable implant and a second connecting portion adapted to connect, directly or indirectly, to at least one fixation member of the maneuverable implant to provide a second, longer distance between at least a portion of the maneuverable implant and at least one fixation member of the maneuverable implant.

[0331] According to one embodiment of the surgical kit, at least one of the at least one first distance element and the at least one second distance element comprises an X-ray detectable element, thereby allowing the distance between at least a portion of the operable implant and at least one fixation member of the operable implant to be measured in an X-ray image.

[0332] In one embodiment of the surgical kit, at least one of the at least one first distance element and the at least one second distance element comprises an ultrasonically detectable element, thereby enabling a distance between at least a portion of the operable implant and at least one fixation member of the operable implant to be measured ultrasonically.

[0333] According to one embodiment, at least one of the at least one first distance element and the at least one second distance element may be adapted for subcutaneous placement.

[0334] At least one of the at least one first distance element and the at least one second distance element may be adapted to be secured to at least one of at least one fascia, at least one osteofascia, at least one cortical bone layer, at least one muscle layer, fibrous tissue, any portion of the abdominal wall, any portion of the subcutaneous space, and surrounding areas within the body.

[0335] At least one of the first and second distance elements in any of the above embodiments of the surgical kit may be adapted to provide a distance between the muscle layer of the abdominal wall and the manipulation device of the manipulable implant.

[0336] At least one of the first and second distance elements of the surgical kit may be adapted for placement through at least one of at least one fascial layer and at least one muscle layer of the abdominal wall.

[0337] At least one of the first and second distance elements may be flexible so that different parts of the steerable implant are movable relative to one another.

[0338] In any of the above embodiments, at least one of the first and second distance elements may not include a magnetic component.

[0339] At least one of the first and second distance elements may be adapted to guide a conductor for transmitting electrical current from the wireless energy receiving unit to a manipulation device of the maneuverable implant.

[0340] At least one of the first and second distance elements may be adapted to fix the wireless energy receiving unit in a suitable position within the patient's body and prevent the body from rejecting the wireless energy receiving unit.

[0341] Also provided is a system for adjusting the distance of a steerable implant, comprising a surgical kit according to any one of the preceding embodiments, wherein the steerable implant comprises at least one fixation member and at least one component selected from the list consisting of: a manipulation device, a control unit, a receiving unit for receiving wireless energy, a coil for receiving wireless energy, a receiving unit for receiving a magnetic or electromagnetic field, a magnetic force transmission coupler, an electrical circuit, a push button for controlling a function of the steerable implant, an energy storage device, a depressible structure for adjusting the adjustable distance element, an integrated manipulation device and receiving unit for receiving wireless energy, a magnetic or electromagnetic field adapted to generate kinetic energy, a case for enclosing at least one of the different portions of the steerable implant, and two or more cases for enclosing at least one of the different portions of the steerable implant within each case. At least one of the first and second distance elements may be adapted to provide a distance between the fixation member and at least one of the components.

[0342] At least one fixation member may be integrated with at least one of: a manipulation device, a control unit, a receiving unit for receiving wireless energy, a coil for receiving wireless energy, a receiving unit for receiving a magnetic or electromagnetic field, a magnetic force transmission coupler, an electrical circuit, a push button for controlling a function of the steerable implant, an energy storage device, a depressible structure for adjusting the adjustable distance element, an integrated manipulation device and receiving unit for receiving wireless energy, a magnetic or electromagnetic field adapted to generate kinetic energy, a case for enclosing at least one different portion of the steerable implant, and two or more cases for enclosing at least one different portion of the steerable implant within each case. At least one of the first and second distance elements: may be adapted to provide a distance between a fixation member integrated with one or more of the above components and one or more other components of any of the above embodiments.

[0343] According to one embodiment, at least one of the first and second distance elements comprises a conductor for transmitting an electric current from the wireless energy receiving unit to the operating device.

[0344] At least a portion of the steerable implant may be adapted for subcutaneous placement, and the steerable device may be adapted for subcutaneous placement.

[0345] According to one embodiment, the manipulation device is adapted to be secured to at least one of the at least one fascial layer and the at least one muscle layer of the abdominal wall.

[0346] The receiving unit may further comprise at least one coil adapted to convert received wireless energy in the form of an electric, magnetic or electromagnetic field into electrical energy. The receiving unit may comprise a first coil having at least a first number of turns and a second coil having at least a second, different number of turns.

[0347] The system may further comprise at least one enclosure adapted to hermetically enclose at least any one component according to any of the above embodiments and the adjustable distance element.

[0348] According to one embodiment, the system further comprises at least one enclosure adapted to sealingly enclose at least one of the components of any of the previous embodiments.

[0349] A control unit of the system may be adapted to control at least one parameter of the operable implant, and the control unit may be adapted to wirelessly communicate with the external unit, thereby allowing the control unit to be controlled wirelessly from outside the body.

[0350] According to one embodiment, the at least one enclosure comprises two or more enclosures, and one of the first and second distance elements may be adapted to adjust the distance between the two enclosures.

[0351] A manipulable implant for implantation in a patient is provided, the manipulable implant comprising a body-engaging portion and a manipulation device for supplying force to the body-engaging portion. The manipulation device comprises an implantable gear system adapted to receive mechanical work at a force input with a first force and velocity and supply mechanical work at a force output with a different second force and velocity to manipulate the body-engaging portion. The gear system comprises a manipulable element connected to the force input, and a hollow cylindrical first gear connected to the force output, the first gear having a first number of teeth on its outer circumference, and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first and second gears.

[0352] According to one embodiment, the operable element is adapted to deflect the first gear and maintain the first gear deflected such that the teeth of the first gear interengage with the teeth of the second gear at one or more angularly spaced positions separated by positions where the teeth do not interengage.

[0353] The operable element may be adapted to bias the first gear and maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear at at least two or more angularly spaced positions separated by positions where the teeth do not interengage.

[0354] According to one embodiment, the manipulation device comprises an implantable electric motor for converting electrical energy into mechanical work, the electric motor being connected to a force input.

[0355] The electric motor may be an electric motor selected from: an alternating current (AC) electric motor; a direct current electric motor; a linear electric motor; an axial electric motor; a piezoelectric motor; a three-phase motor; a two or more phase motor; a bimetallic motor; and a shape memory metal motor.

[0356] The maneuverable implant according to any one of the above embodiments may further comprise a magnetic coupler connected to the force input, whereby mechanical work of a first force and rate is supplied by the magnetic coupler to the gear system, and the magnetic coupler may be connected to the force output, whereby mechanical work of a second force and rate is supplied by the magnetic coupler to the body engaging portion.

[0357] According to one embodiment, the magnetic coupler is adapted to transmit at least one of a rotational force and a reciprocating force.

[0358] The magnetic coupler may comprise a rotating element disposed inside a sealed enclosure surrounding at least the gear system of the steerable implant, the rotating element comprising at least one magnet or portion including a magnetic or magnetizable material, the magnet or portion including a magnetic or magnetizable material may be adapted to rotate and transmit a force to a corresponding rotating element outside the sealed enclosure to supply a force directly or indirectly to the body engaging portion via the sealed enclosure.

[0359] The magnetic coupler may comprise a rotating element disposed inside a sealed enclosure comprising at least one magnet or portion containing magnetic or magnetizable material, and adapted to be rotated upon receiving a transmitted force from a corresponding external rotating element disposed outside the sealed enclosure and outside the body to directly supply a force to the rotating element disposed inside the sealed enclosure.

[0360] The steerable implant may further comprise an enclosure adapted to sealingly surround the steerable implant.

[0361] The gear system in any of the above embodiments may further include a hollow cylindrical third gear, the inside of which may include the same number of teeth as the outside of the first gear, and the teeth of the third gear may be adapted to interengage with the teeth of the first gear, thereby causing the third gear to rotate relative to the second gear along at least one interengaging position.

[0362] According to one embodiment, the third gear connects to a second gear system, whereby the first and second gear systems function as a single gear system. The second gear system includes a force input adapted to receive mechanical work from the force output of the first gear system at a second force and a second speed, and a force output adapted to supply mechanical work to the body-engagement part with a third force and a third speed. The second gear system may include a manipulable element connected to the force input of the second gear system, a first gear connected to the force output of the second gear system that is hollow cylindrical and has a first number of teeth on its outer circumference, and a second gear that is hollow cylindrical and has a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element causes relative rotation between the first gear and the second gear by advancing the at least one position.

[0363] According to one embodiment, the operable element of at least one of the first and second gear systems comprises at least one of: a planetary gear, and a structure or wheel that at least partially uses frictional forces to enable the transfer of rotational force.

[0364] In any of the above embodiments, the force outputs of the first and second gear systems may be directly or indirectly connected to threaded members adapted to convert rotational force into linear force.

[0365] According to another embodiment, the manipulatable implant further comprises a reservoir comprising a movable wall portion adapted to vary the volume of the reservoir, The threaded member may be directly or indirectly connected to the movable wall portion, whereby manipulation of the threaded member varies the volume of the reservoir.

[0366] In some embodiments, the manipulable implant comprises a second reservoir comprising a movable wall portion, and the threaded member may be directly or indirectly connected to the movable wall portion of the second reservoir for varying the volume of the second reservoir. Movement of the movable wall portion of the first reservoir may cause the threaded member to expand the first reservoir in a first direction, increasing the volume of the first fluid reservoir, and movement of the movable wall portion of the second reservoir may cause the threaded member to contract the second reservoir in a first direction, decreasing the volume of the second reservoir.

[0367] The first reservoir may be in fluid communication with the first body engaging portion and the second reservoir may be in fluid communication with the second body engaging portion, and operation of the operating device in a first direction may effect, by connection with the threaded member: transport of fluid from the first reservoir to the first body engaging portion, and transport of fluid from the second body engaging portion to the second reservoir.

[0368] The reservoir in any of the above embodiments may be at least one of circular and donut-shaped.

[0369] The steerable implant in any of the above embodiments may further comprise a peristaltic pump comprising a hollow member for transporting fluid and an operable compression member adapted to engage and compress the hollow member. The force output may be directly or indirectly connected to the compression member, whereby operation of the manipulation device operates the compression member such that fluid is transported into the hollow member.

[0370] The steerable implant may further comprise a friction coupling adapted to limit the rotational force that can be provided by the steering device. The friction coupling may be positioned between the steering device and the body engaging portion, thereby reducing the rotational force required to actuate the steering device.

[0371] The manipulatable implant may further comprise a reservoir for holding hydraulic fluid, the reservoir comprising a movable wall portion adapted to vary the volume of the reservoir, the movable wall portion may be directly or indirectly connected to a force output of the gear system, whereby manipulation of the gear system varies the volume of the reservoir.

[0372] The electric motor in any one of the above embodiments may be a one-phase, two-phase, three-phase or more-phase motor comprising at least one of an axial type electric motor, a radial type electric motor, and a linear type electric motor.

[0373] The steerable implant may further comprise a separate receiving unit adapted to receive wireless energy, and the receiving unit may comprise at least one coil adapted to convert the received wireless energy in the form of a magnetic field, an electric field or an electromagnetic field into electrical energy.

[0374] The operable implant may further comprise at least one distance element adapted to provide a distance between the receiving unit and at least one of the metallic, magnetic or magnetizable portions of the patient's skin and any of the operable implant, whereby the receiving unit remains substantially unaffected by the metallic and / or magnetic portions of the operable implant.

[0375] At least one distance element may be adjustable.

[0376] The manipulable implant may further comprise at least one fixation member for fixing at least a portion of the manipulable implant to at least one of fascia, osteofascia, cortical bone, muscle layer, fibrous tissue, and at least one layer facing inwardly of the patient's subcutaneous space.

[0377] There is also provided a medical system for transmitting energy from outside a patient's body to a steerable implant disposed inside the patient's body. The medical system includes: an external drive unit; and the steerable implant. The external drive unit includes an external rotating structure including at least one magnet for forming a rotating magnetic field, adapted to magnetically couple to at least one of a magnet, magnetizable material, or magnetic material of the steerable implant for transmitting force from the external drive unit to the magnet or magnetic material of the implant within the patient's body, and at least one coil of the steerable implant for inducing an electric current within the patient's body. The provided medical system is capable of transmitting dynamic rotational force for directly or indirectly powering the medical implant.

[0378] The magnet or magnetic material of the steerable implant may be fixed to an internal rotating structure adapted to rotate along the rotating magnetic field of an external drive unit for manipulating the steerable implant.

[0379] According to one embodiment, the magnet or magnetic material of the steerable implant may be fixed to an internal reciprocating structure adapted to coincide with the rotating magnetic field of an external drive unit for manipulating the steerable implant.

[0380] The internal reciprocating structure may be adapted to reciprocate by magnetic coupling with a magnetic field of alternating polarity, whereby the magnets of the internal reciprocating structure are alternately attracted and repelled by a rotating magnetic field created by an external drive unit.

[0381] The outer rotating structure may have a larger diameter than the inner rotating structure, and the magnets may be positioned such that a radial force is exerted by the magnets that allows the magnets of the inner rotating structure to rotate along with the magnets of the outer rotating structure, pressing the inner structure against the outer structure, thereby reducing the risk that the magnetic force will damage the patient's skin.

[0382] According to one embodiment, at least one of the internal and external rotating structures may comprise a repelling magnet adapted to reduce the axial force created by the magnetic coupler between the internal and external magnets and / or magnetic materials, thereby reducing the squeezing effect on the patient's skin.

[0383] The force of the repulsive or attractive magnet may be adjustable, thereby adjusting the squeezing effect on the patient's skin.

[0384] The attracting magnet in any of the above embodiments may be an attracting electromagnet, and the force of the counter-generating magnet may be adjusted by varying the current to the electromagnet.

[0385] According to one embodiment, the repulsive magnets are permanent magnets, and the force of the repulsive permanent magnets may be adjusted by varying the distance between or the position of the permanent magnets relative to the patient's skin.

[0386] The inner rotating structure may comprise an inner spherical cap, and the magnet or magnetic material of the inner rotating structure may be positioned outside the inner spherical cap. The outer rotating structure may comprise an outer spherical cap, and the magnet or magnetic material of the outer rotating structure may be positioned inside the outer spherical cap, whereby rotational forces may be transmitted radially by a magnetic coupler between the inner and outer spherical caps.

[0387] According to one embodiment, the inner spherical cap comprises a centrally located magnet and the outer spherical cap comprises a centrally located magnet, the magnets of the inner and outer spherical caps being adapted to exhibit a repulsive force to each other, thereby reducing the axial force created by the magnetic coupling between the inner and outer magnets and / or magnetic materials, thereby reducing the squeeze effect on the patient's skin.

[0388] The medical system may further include a gear system connected to the internal rotating structure, the gear system adapted to receive mechanical work at a first force and velocity and to supply mechanical work having a different force and velocity.

[0389] The gear system may include: an operable element; a first gear having a first number of teeth on its exterior; and a second gear having a greater number of teeth on its interior than the first gear. The operable element may be adapted to press the exterior of the first gear against the interior of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and operation of the operable element advances said positions, thereby generating relative rotation between the first and second gears.

[0390] According to one embodiment, the maneuverable implant comprises a manipulation device and a body engaging portion. The manipulation device may comprise a hydraulic manipulation device. The body engaging portion may be a hydraulically maneuverable body engaging portion, and the maneuverable implant may further comprise a hydraulic pump and a reservoir adapted to hold hydraulic fluid, the reservoir connected to the hydraulic pump. The hydraulic pump may be adapted to transport hydraulic fluid from the reservoir to the body engaging portion.

[0391] The hydraulic pump may comprise a movable wall portion of the reservoir, and the hydraulic pump may be adapted to transport hydraulic fluid from the reservoir to the hydraulically operable body-engaging portion by moving the movable wall portion to vary the volume of the reservoir.

[0392] According to one embodiment, the manipulation device comprises an electric motor comprising a stationary part comprising a plurality of coils and a movable part comprising a plurality of magnets, whereby sequential energization of the coils magnetically propels the magnets and thereby the movable part. The manipulation device may further comprise an enclosure adapted to hermetically surround the coils of the stationary part, whereby a seal is formed between the stationary part and the propelled movable part housing the magnets, whereby the coils of the stationary part are sealed from body fluids when implanted.

[0393] The medical system may further comprise an implantable generator, the implantable generator comprising: at least one generating magnet connected to the magnet or magnetic material of the operable implant, whereby movement of the magnet or magnetic material causes movement of the movable generating portion; a movable generator; and at least one coil magnetically coupled to the at least one generating magnet, whereby movement of the movable generating portion relative to the coil induces a current in the coil.

[0394] According to one embodiment, the movable generating part is adapted to undergo a rotational movement.

[0395] The implantable generator may be an implantable rotary generator, the movable generating portion may be adapted to undergo rotational motion, and the at least one coil may be magnetically coupled to at least one magnet, whereby rotational motion of the movable generating portion induces a current in the at least one coil.

[0396] The movable generating portion may be adapted to undergo reciprocating motion.

[0397] The implantable generator may be an implantable linear generator, the movable generating portion may be adapted to undergo reciprocating motion, and the at least one coil may be magnetically coupled to at least one magnet, whereby the reciprocating motion of the movable generating portion induces a current in the at least one coil.

[0398] According to one embodiment, the steerable implant comprises a plurality of coils arranged in a circular fashion, whereby a magnetic field rotated by an external drive unit sequentially induces electrical currents in the plurality of coils.

[0399] The medical system may further comprise at least one battery or energy storage device connected to the at least one coil, thereby enabling the current induced in the at least one coil to be stored as electrical energy in the battery.

[0400] The medical system may further comprise an enclosure adapted to hermetically surround the steerable implant, whereby the steerable implant is sealed from the patient's bodily fluids. The medical system according to any one of the above embodiments may further comprise a wireless communication unit, the wireless communication unit adapted to at least one of receive wireless communication signals from an external unit and transmit wireless communication signals to the external unit.

[0401] The steerable implant in any of the embodiments may be adapted to be implanted subcutaneously.

[0402] According to one embodiment, the steerable implant comprises a steering device and a body-engaging portion. The steering device comprises: a movable part connected directly or indirectly to the body-engaging portion, the movable part being connected to at least one magnet, magnetizable material, or magnetic material. The movable part may be adapted to be magnetically coupled to a movable magnetic field outside the patient's body, whereby the movable part moves along the movable magnetic field. The steering device further comprises an implantable generator connected to the movable part and adapted to convert motion into electric current, whereby motion of the movable part operates the body-engaging portion and generates electric current.

[0403] At least one magnet, magnetizable material or magnetic material may be connected to the rotating structure and adapted to magnetically couple to the rotating magnetic field outside the patient's skin, causing the rotating structure to rotate along the rotating magnetic field.

[0404] At least one magnet, magnetizable material, or magnetic material may be connected to the structure adapted for reciprocation and adapted to be magnetically coupled to the reciprocating magnetic field outside the patient's skin, whereby the structure for reciprocation moves along the reciprocating magnetic field.

[0405] The implantable generator may further comprise at least one magnet and at least one coil, and movement of the at least one magnet relative to the at least one coil may induce a current in the at least one coil. The at least one magnet of the moving part may be adapted to magnetically couple to a moving magnetic field outside the patient's body and also function as the at least one magnet in the implantable generator.

[0406] According to one embodiment, the device further comprises a battery or energy storage means adapted to be charged by the implantable generator. The battery or energy storage means may be adapted to power the body engaging portion.

[0407] The steerable implant may further comprise a control unit for controlling at least one parameter of the steerable implant.

[0408] The control unit is connected to a battery or energy storage means whereby the battery powers the control unit.

[0409] The operating device may comprise a hydraulic operating device.

[0410] According to one embodiment, the body engaging portion may be a hydraulically operable body engaging portion, and the operable implant may further comprise a hydraulic pump and a reservoir adapted to hold hydraulic fluid, the reservoir connected to the hydraulic pump. The hydraulic pump may be adapted to transport hydraulic fluid from the reservoir to the body engaging portion.

[0411] The hydraulic pump may comprise a movable wall portion of the reservoir, and the hydraulic pump may be adapted to transport hydraulic fluid from the reservoir to the hydraulically operable body-engageable portion by moving the movable wall portion to vary the volume of the reservoir.

[0412] According to one embodiment, the hydraulic pump may be a hydraulic pump selected from: a peristaltic pump, a diaphragm pump, a gear pump, and a bellows pump.

[0413] The manipulation device in any of the above embodiments may include a gear system adapted to receive mechanical work of a first force and velocity as an input and to output mechanical work having a different force and velocity.

[0414] The gear system of the manipulation device may include: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear. The operable element may be adapted to engage the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage. Manipulation of the operable element advances the positions, thereby generating relative rotation between the first gear and the second gear.

[0415] According to one embodiment, the operable element connects to a moving part, whereby movement of the moving part operates a gear system.

[0416] According to one embodiment, the steerable implant further comprises an enclosure adapted to surround the steerable implant.

[0417] In any of the above embodiments, the moving parts of the gear system may be adapted to be placed subcutaneously.

[0418] The manipulation device may be adapted to be secured to at least one of fascia, fibrous tissue, skin, muscle layer, or any tissue subcutaneously within the abdominal wall or abdomen.

[0419] The manipulation device may further comprise a distance element adapted to provide a distance between the manipulation device and the movable part.

[0420] The distance element may be adapted to control the position of the moving part to prevent the body from rejecting the moving part.

[0421] According to one embodiment of the steerable implant, the steerable implant further comprises a wireless communication unit adapted for wireless communication with an external unit.

[0422] According to one embodiment, the system further comprises an external unit comprising an external drive unit for providing a drive force to the steerable implant.

[0423] The external drive unit may comprise a moving magnet adapted to generate a moving magnetic field, or may comprise coils, the sequential energization of which generates the moving magnetic field.

[0424] According to one embodiment, the external drive unit further comprises a wireless communication unit adapted to wirelessly communicate with the steerable implant.

[0425] There is also provided an actuatable hydraulic implant comprising a body engaging portion and a powered actuation device in fluid communication with the body engaging portion. The actuation device comprises: a reservoir for holding hydraulic fluid and comprising a movable wall portion adapted to move to vary a volume of the reservoir, thereby transporting the hydraulic fluid from the reservoir to the body engaging portion; an actuation member connected to the movable wall portion, whereby actuation of the actuation member varies the volume of the reservoir; and a flexible enclosure adapted to surround the movable wall portion and the actuation member, the flexible enclosure having a volume that varies with changes in its outer dimensions and shape. The movable wall portion may be adapted to move inside the enclosure, whereby the volume of the reservoir is alterable by movement of the movable wall portion inside the enclosure, affecting the outer dimensions of the actuatable hydraulic implant.

[0426] The reservoir comprises a manual portion adapted to be manually depressed from outside the patient's body, thereby transporting fluid from the reservoir to a body-engaging portion of the manually operable hydraulic implant to temporarily increase hydraulic pressure in the body-engaging portion. The manual portion may allow for manual override and / or additional pressure on the reservoir and / or emergency operation.

[0427] The reservoir in any of the above embodiments may be substantially circular or oval.

[0428] According to one embodiment, the average thickness of the movable wall portion is less than the average thickness of the manual portion of the reservoir.

[0429] According to one embodiment of the steerable hydraulic implant, the reservoir comprises Parylene® coated silicone.

[0430] In one embodiment, the manipulation device may be connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, the threaded member being connected to the manipulation member.

[0431] The operable hydraulic implant may further comprise an electrical circuit and a control unit for controlling the operable hydraulic implant.

[0432] The operable hydraulic implant may further comprise an inlet for injecting hydraulic fluid into the reservoir from outside the patient's body.

[0433] At least a portion of the steerable hydraulic implant may be adapted to be implanted subcutaneously.

[0434] The maneuverable hydraulic implant may further comprise at least one fixation member adapted to directly or indirectly fix at least a portion of the maneuverable hydraulic implant to at least one of at least one fascia, at least one osteofascia, at least one cortical bone layer, at least one muscle layer, fibrous tissue, any portion of the abdominal wall, any portion of the subcutaneous space, and surrounding areas within the body.

[0435] The manipulable hydraulic implant may further comprise a second body engaging portion and a second reservoir in fluid communication with the second body engaging portion. The second reservoir may comprise a movable wall portion adapted to move to vary a volume of the second reservoir, thereby transporting hydraulic fluid from the second reservoir to the second body engaging portion.

[0436] The movable walls of the first and second reservoirs may be connected to the same operating member adapted to increase or decrease the size of the reservoirs, and the volume of the first reservoir may be adapted to change in the opposite direction to that of the second reservoir.

[0437] According to one embodiment, the operating device comprises an electric motor connected to the operating member, which may be an electric motor selected from: an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a piezoelectric motor, a two or more phase motor, a three phase motor, a bimetallic motor, and a shape memory metal motor.

[0438] According to one embodiment, operation of the electric motor affects the movable walls of both the first and second reservoirs.

[0439] The manipulation device may comprise a gear system adapted to receive mechanical work of a first force and velocity and to supply mechanical work having a different second force and velocity, the gear system may comprise a force input connected to the electric motor and a force output connected directly or indirectly to the manipulation member.

[0440] The gear system comprises: an operable element; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the operable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear at at least one position separated by a position where the teeth do not interengage, and wherein operation of the operable element advances said positions, thereby generating relative rotation between the first gear and the second gear.

[0441] The gear system may be connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, the threaded member being connected to an operating member.

[0442] According to one embodiment, the manipulation device comprises a magnetic coupler adapted to magnetically couple with an outer portion of the magnetic coupler adapted to be positioned outside the patient's body, whereby an inner portion of the magnetic coupler moves along the outer portion of the magnetic coupler to manipulate the movable wall portion.

[0443] The steerable hydraulic implant may further comprise a wireless communication unit for wirelessly communicating with an external unit positioned outside the patient's body.

[0444] The operable hydraulic implant may further comprise at least one battery adapted to store electrical energy in the patient's body.

[0445] There is also provided a medical system comprising a steerable implant adapted for placement inside a patient's body, the steerable implant comprising a movable structure adapted for reciprocating movement, the movable structure comprising at least one magnet or magnetic material, the movable structure may be adapted to magnetically couple with an external unit that generates a reciprocating magnetic or electromagnetic field, whereby the movable structure reciprocates along the reciprocating magnetic or electromagnetic field.

[0446] According to one embodiment, the steerable implant further comprises a generator connected to the movable structure and adapted to convert the reciprocating movement of the movable structure into electrical energy.

[0447] The generator may comprise: a movable generating part comprising at least one magnet and connected to the movable structure, and at least one coil in magnetic communication with the at least one magnet, wherein movement of the movable generating part relative to the coil induces a current in the coil.

[0448] According to one embodiment, at least one magnet of the movable generating part is a magnet of the movable structure.

[0449] The steerable implant may further comprise a power conversion member adapted to convert the reciprocating force into a rotational force. The generator may be a rotary generator connected to the power conversion member.

[0450] The generator may be a linear generator comprising: a reciprocating power generating portion having at least one magnet and connected to a movable structure adapted to undergo reciprocating motion, and at least one coil magnetically coupled to the at least one magnet, whereby a current is induced by the reciprocating motion of the reciprocating power generating portion.

[0451] According to one embodiment, the movable structure is a spring loaded in one direction, which causes a reciprocating motion due to the magnetic force from a magnetic coupler connected to an external unit in one direction and the movable part being spring loaded in the opposite direction.

[0452] The operable implant may further comprise a battery or energy storage device connected to the generator unit, the battery being adapted to store electrical energy generated in the generator unit.

[0453] According to one embodiment, the steerable implant may further comprise a body engaging portion connected to the movable structure, whereby movement of the movable structure manipulates the body engaging portion.

[0454] The medical system in any of the above embodiments may further comprise an enclosure adapted to hermetically surround the steerable implant, thereby sealing the implantable generator from the patient's bodily fluids.

[0455] The medical system according to any one of the above embodiments may further comprise a wireless communication unit adapted to perform at least one of: receiving a wireless communication signal from an external unit; and transmitting a wireless communication signal to the external unit.

[0456] The steerable implant in any of the above embodiments may be adapted to be implanted subcutaneously, which may be subcutaneously in the abdominal region.

[0457] According to one embodiment, the maneuverable implant further comprises an external unit comprising an external drive unit adapted to generate a reciprocating magnetic field outside the patient's skin adapted to influence at least one magnet or magnetic material of the maneuverable implant, whereby the magnet or magnetic material reciprocates along the reciprocating magnetic field of the external unit.

[0458] The external drive unit may further comprise a reciprocating structure comprising at least one magnet, electromagnet, or magnetic material, and the reciprocating movement of the reciprocating structure may affect the magnet or magnetic material of the movable structure of the implantable generator, causing it to reciprocate.

[0459] According to one embodiment, the external drive unit may comprise a rotatable structure comprising at least one magnet, electromagnet or magnetic material, the rotation of which influences the magnet or magnetic material of the movable structure of the implantable generator to cause it to move in a reciprocating manner.

[0460] The rotatable structure of the external drive unit may comprise: a first magnet or electromagnet that generates a positive magnetic field, and a second magnet or electromagnet that generates a negative magnetic field, whereby rotation of the rotatable structure causes the first and second magnets or electromagnets to alternately influence the magnet or magnetic material of the operable implant, causing it to move back and forth.

[0461] In one embodiment, the external drive unit comprises an electromagnet for generating alternating magnetic fields having positive and negative polarities to reciprocate the magnet or magnetic material of the implantable generator.

[0462] According to one embodiment, the manipulable implant further comprises a gear system adapted to receive as input mechanical work of a first force and speed and to output mechanical work having a different force and speed, the gear system comprising: a manipulable element, a first gear of hollow cylindrical shape with a first number of teeth on its outer circumference, and a second gear of hollow cylindrical shape with a greater number of teeth on its inner surface than the first gear, the manipulable element being adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and manipulation of the manipulable element causes relative rotation between the first gear and the second gear by advancing said positions.

[0463] According to one embodiment, a steerable implant comprises a steering device and a body-engaging portion, the steering device comprising an electric motor comprising a stationary portion comprising a plurality of coils and a movable portion comprising a plurality of magnets, whereby sequential energization of the coils magnetically propels the magnets and thereby the movable portion, the steering device further comprising an enclosure adapted to hermetically surround the coils of the stationary portion, whereby a seal is formed between the stationary portion and the propelled movable portion housing the magnets, whereby the coils of the stationary portion are sealed from body fluids upon implantation.

[0464] According to one embodiment, the external unit is configured to: receive wireless communication signals from the operative implant; and - further comprising a wireless communication unit adapted to perform at least one of: transmitting a wireless communication signal to the operable implant.

[0465] A medical system for forming a magnetic coupling between an external unit and a maneuverable implant is provided. The medical system includes: a maneuverable implant comprising at least one of a magnet, a magnetic material, and a magnetizable material; and an external unit comprising at least one of an external permanent magnet and an external electromagnet adapted to magnetically couple with the magnet, the magnetic material, and the magnetizable material of the maneuverable implant. The magnetic force of the external magnet is modifiable or adjustable, thereby modulating or adjusting the squeezing force exerted on the patient's skin. In this way, the medical system reduces the risk of damaging the patient's skin.

[0466] According to one embodiment, the external magnet comprises at least one permanent magnet, and the external unit further comprises: a skin contact portion and an adjustment device for adjusting the distance of the permanent magnet from the skin contact portion or its position relative to the skin contact portion.

[0467] According to one embodiment, the maneuverable implant comprises: a first magnet, at least one of a first section of magnetic material and a first section of magnetizable material; and at least one of a second magnet, a section of second magnetic material and a second section of magnetizable material. The external unit may comprise: at least one first magnet or first electromagnet and at least a second magnet or second electromagnet, wherein at least one of the first magnet, magnetic material and portion of magnetizable material of the maneuverable implant is adapted to be attracted to the first magnet or first electromagnet of the external unit, and at least one of the second magnet, magnetic material and portion of magnetizable material of the maneuverable implant is adapted to be repelled by the second magnet or second electromagnet of the external unit to balance the squeezing force exerted on the patient's skin.

[0468] According to one embodiment, the external unit is adapted to generate first and second magnetic fields with different polarities at different locations or at different times at the same location. The steerable implant may be adapted to generate first and second magnetic fields with different polarities at different locations, the first magnetic field being adapted to reduce the attractive force between the steerable implant and the external unit generated by the second magnetic field, thereby reducing the squeezing effect on the patient's skin.

[0469] According to one embodiment, the external unit comprises at least one electromagnet, the external unit comprising a control unit for controlling the magnetic force of the electromagnet.

[0470] According to one embodiment, the medical system is adapted to transmit a motive force from an external unit to the operable implant by magnetic coupling, the external unit comprising an external drive unit adapted to form a moving magnetic field adapted to magnetically couple to the operable implant to transmit a force from the external drive unit to at least one of a magnet, a magnetic material and a magnetizable material of the operable implant.

[0471] According to one embodiment, the medical system is adapted to transmit a rotational force through the patient's skin, and the external drive unit comprises an external rotating structure comprising at least one of at least one permanent magnet and at least one electromagnet to form a rotating magnetic field adapted to magnetically couple to the internal rotating structure, whereby the internal rotating structure rotates along with the external rotating structure. The squeeze force on the patient's skin induced by the magnets of the internal and external rotating structures can be adjusted so that the rotational force can be transmitted without applying excessive force to the patient's skin.

[0472] According to one embodiment, the outer rotating structure has a larger diameter than the inner rotating structure, and the magnets are positioned so that the radial force that allows the magnets of the inner rotating structure to rotate along with the magnets of the outer rotating structure is stronger than the axial force that presses the inner structure against the outer structure.

[0473] According to one embodiment, the external unit is adapted to generate a rotating magnetic field having both the first and second magnetic fields according to any of the above embodiments, wherein the rotating magnetic field is in the form of at least one of the following options:

[0474] 1. A first magnetic field is formed when rotating the external rotating structure described in at least embodiment 7, and has at least one of an angularly intermittent first magnetic field, a central first magnetic field, and a substantially continuous first magnetic field around it, and additionally forms at least a portion of a magnetic coupling force that enables rotation of the internal rotating structure, and is involved in at least one of the rotational movement of the external rotating structure and the rotational movement of the magnetic field formed by the rotating structure, and the force of squeezing the patient's skin is reduced by the first magnetic field.

[0475] 2. The first magnetic field is formed by one or more negative-pole permanent magnets arranged on both the internal and external rotating structures, and has at least one of an angularly intermittent first magnetic field, a central first magnetic field, and a substantially continuous peripheral first magnetic field, and additionally forms at least a portion of the magnetic coupling force that enables rotation of the internal rotating structure described in embodiment 7, and is involved in at least one of the rotational movement of the external rotating structure and the rotational movement of the magnetic field formed by the stationary rotating structure, and the force of squeezing the patient's skin is reduced by the first magnetic field.

[0476] 3. The first magnetic field is formed by one or more negative-pole permanent magnets disposed on both the internal and external rotating structures to form a repulsive magnetic force between the internal and external rotating structures, the permanent magnets adapted to form at least one of an angularly intermittent first magnetic field, a central first magnetic field, and a peripheral substantially continuous first magnetic field.

[0477] 4. The first magnetic field is formed by one or more negative-pole permanent magnets arranged on an internal rotating structure, the permanent magnets adapted to form at least one of an angularly intermittent second magnetic field, a central second magnetic field, and a peripheral substantially continuous second magnetic field, and the magnetic field formed by the internal rotating structure is adapted to form a magnetic coupling force toward the external unit.

[0478] 5. The second magnetic field is adapted to be formed by an external structure comprising at least one of two or more coils and two or more positive-pole permanent magnets; when two or more permanent magnets are provided and the external rotating structure rotates to rotate the internal rotating structure via the rotating magnetic field described in embodiment 7, thereby forming a magnetic coupling force; and when two or more coils are provided and the external rotating structure is stationary, while sequential energy supply to the coils rotates the magnetic field of the external rotating structure, thereby rotating the internal rotating structure via the rotating magnetic field, thereby forming at least a portion of the magnetic coupling force that enables rotation of the internal rotating structure. The second magnetic field forms at least one of an angularly intermittent second magnetic field, a central second magnetic field, and a peripheral substantially continuous second magnetic field.

[0479] 6. The second and first magnetic fields are adapted to be formed at least in part in the outer structure, and include one or more coils, one or more positive permanent magnets, and one or more negative permanent magnets adapted to form at least one of the angularly intermittent second and first magnetic fields, the central second or first magnetic field, and the substantially continuous peripheral second or first magnetic field, and both the second and first magnetic fields are formed by one or more negative permanent magnets disposed in the inner rotating structure, the permanent magnets adapted to form at least one of the angularly intermittent second magnetic field, the central second magnetic field, and the substantially continuous peripheral second magnetic field, and the magnetic field formed by the inner rotating structure is selected from the following options: two or more positive permanent magnets magnetically coupled with two or more negative permanent magnets of the inner structure, and the outer rotating structure rotates. and wherein the external unit is adapted to form a magnetic coupling force toward the external unit in at least one of the following situations: when the external unit is configured to rotate the internal rotating structure by a rotating magnetic field to form at least a part of the magnetic coupling force; when the external unit is configured to rotate two or more negative-pole permanent magnets in magnetic coupling with two or more negative-pole permanent magnets of the internal unit, and the external unit is configured to rotate the internal rotating structure by a rotating magnetic field as described in embodiment 7 to form at least a part of the magnetic coupling force; and when the external unit is configured to rotate two or more negative-pole permanent magnets in magnetic coupling with two or more negative-pole permanent magnets of the internal unit, and the external unit is configured to rotate the internal rotating structure by a rotating magnetic field as described in embodiment 7, and the external unit is configured to rotate two or more coils in magnetic coupling with two or more negative-pole permanent magnets of the internal unit, and the external unit is configured to rotate the magnetic field of the external unit by sequentially supplying energy to the coils to rotate the internal rotating structure by a rotating magnetic field as described in embodiment 7 to form at least a part of the magnetic coupling force that allows the internal rotating structure to rotate.

[0480] 7. The second and first magnetic fields are adapted to be rotated at least in part by an internal structure, and the second and first magnetic fields comprise one or more coils, one or more positive polarity permanent magnets, and one or more negative polarity permanent magnets adapted to form at least one of angularly intermittent second and first magnetic fields, a central second or first magnetic field, and a peripheral substantially continuous second or first magnetic field.

[0481] According to one embodiment, the inner rotating structure comprises an inner spherical cap, and the magnet or magnetic material of the inner rotating structure is disposed outside the inner spherical cap, and the outer rotating structure comprises an outer spherical cap, and the magnet of the outer rotating structure is disposed inside the outer spherical cap, so that rotational force can be transmitted radially by magnetic coupling between the inner and outer spherical caps.

[0482] According to one embodiment, the medical system further comprises an implantable generator, the implantable generator comprising: at least one power-generating magnet adapted to be magnetically coupled to at least one of the magnet, magnetic material and magnetizable material of the operable implant, whereby movement of at least one of the magnet, magnetic material and magnetizable material causes movement of or becomes the movable power-generating part; and at least one coil magnetically coupled to the at least one power-generating magnet, whereby movement of the movable power-generating part relative to the coil induces a current in the coil.

[0483] According to one embodiment, the movable generating part is adapted to undergo a rotational movement.

[0484] According to one embodiment, the implantable generator is an implantable rotary generator, wherein the movable generating portion is disposed on an internal rotating structure and adapted to undergo rotational movement, and the at least one coil is magnetically coupled to at least one magnet, whereby rotational movement of the movable generating portion induces a current in the at least one coil.

[0485] According to one embodiment, the movable generating part is adapted to undergo a reciprocating motion.

[0486] According to one embodiment, the implantable generator is an implantable linear generator, the movable generating portion is adapted to undergo reciprocating motion, and the at least one coil is adapted to be magnetically coupled to the at least one magnet, whereby the reciprocating motion of the movable generating portion induces a current in the at least one coil.

[0487] According to one embodiment, the external unit is adapted to generate a rotating magnetic field, and the steerable implant comprises a plurality of coils adapted to be magnetically coupled with the rotating magnetic field and arranged in a circular pattern, whereby the rotating magnetic field sequentially induces currents in the plurality of coils.

[0488] In one embodiment, the external unit comprises a wireless energy transmitter and the steerable implant further comprises a wireless energy receiver, whereby wireless energy can be transmitted from the external unit to the internal unit. The wireless energy transmitter may comprise a wireless energy transmitting coil and the wireless energy receiver may comprise a wireless energy receiving coil.

[0489] The medical system may further comprise at least one battery adapted to store electrical energy.

[0490] According to one embodiment, the external unit comprises a wireless communication unit and the medical system comprises a wireless communication unit, whereby the external unit and the operable implant can communicate wirelessly.

[0491] The medical system may further comprise an enclosure adapted to sealingly surround the steerable implant, thereby sealing the steerable implant from the patient's bodily fluids.

[0492] According to one embodiment, the steerable implant may be adapted for subcutaneous implantation.

[0493] Also provided is a steerable implant comprising: an electric motor adapted to convert electrical energy into mechanical work and adapted to output mechanical work at a first force and velocity; and a gear system adapted to receive as input the mechanical work at the first force and velocity from the electric motor and to output mechanical work having a second, different force and velocity. The medical system further comprises: a first force output adapted to output mechanical work from the electric motor with the first force and velocity, and a second force output adapted to output mechanical work from the gear system with the second force and velocity.

[0494] According to one embodiment, the steerable implant further comprises an implantable generator, the first force output being connected to the implantable generator for generating an electrical current inside the patient's body.

[0495] According to one embodiment, the maneuverable implant further comprises a maneuverable body engaging portion connected to and manipulated by a second force output of the manipulation device.

[0496] The actuatable body engaging portion may be a hydraulically actuatable body engaging portion, and the operating device may further comprise a hydraulic pump for transmitting hydraulic fluid to the hydraulically actuatable body engaging portion.

[0497] The hydraulic pump of the operable implant may comprise a reservoir adapted to contain hydraulic fluid, the reservoir may comprise a movable wall portion for varying the volume of the reservoir, and the movable wall portion may be connected to an operating device, whereby the operating device operates the movable wall portion.

[0498] The hydraulic pump may be a hydraulic pump selected from: at least one valveless pump; at least one valve pump; at least one peristaltic pump; at least one membrane pump; at least one gear pump; and at least one bellows pump.

[0499] According to one embodiment, at least one of the first and second force outputs is connected to a threaded member adapted to convert a radial rotational force into an axial reciprocating force, the threaded member may be directly or indirectly connected to a movable wall portion of the reservoir to vary the volume of the reservoir.

[0500] The threaded member may be directly or indirectly mechanically connected to the body engaging portion, whereby the body engaging portion is manipulated via the threaded member.

[0501] According to one embodiment, the gear system of the manipulable implant comprises: a manipulable element connected to a first force output; a hollow cylindrical first gear having a first number of teeth on its outer circumference; and a hollow cylindrical second gear having a greater number of teeth on its inner surface than the first gear, wherein the manipulable element is adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, and manipulation of the manipulable element causes relative rotation between the first gear and the second gear by advancing said positions, and the first gear is connected to a second force output for outputting mechanical work having a second force and speed.

[0502] According to one embodiment, the manipulation device further comprises a second gear system adapted to receive mechanical work of a second force and velocity from the first gear system as an input and to output mechanical work having a third, different force and velocity.

[0503] According to one embodiment, the manipulation device further comprises a third force output adapted to output mechanical work from the second gear system with a third force and speed.

[0504] The second gear system may comprise: an operable element connected to the second output, a first gear having a hollow cylindrical shape with a first number of teeth on its outer circumference, and a second gear having a hollow cylindrical shape with a greater number of teeth on its inner surface than the first gear, the operable element adapted to engage with the inside of the first gear, whereby the outside of the first gear is pressed against the inside of the second gear, whereby the teeth of the first gear interengage with the teeth of the second gear in at least one position separated by a position where the teeth do not interengage, operation of the operable element causes relative rotation between the first gear and the second gear by advancing said positions, and the first gear connected to a third force output for outputting mechanical work having a third force and speed.

[0505] According to one embodiment, the steerable implant further comprises an enclosure adapted to surround the steering device.

[0506] The enclosure may comprise a first and a second penetration, the first penetration may be adapted to a first force output and the second penetration may be adapted to a second force output.

[0507] In one embodiment, the enclosure comprises first, second and third feedthrough outputs.

[0508] According to one embodiment, the enclosure comprises first, second and third penetrations. The first penetration is adapted to a first force output, the second penetration is adapted to a second force output, and the third penetration is adapted to a third force output. The first force output may be connected to a first hydraulic pump for operating the first body engagement portion, and the second force output may be connected to a second hydraulic pump for operating the second body engagement portion.

[0509] According to one embodiment, the first force output comprises a first rotatable shaft and the second force output comprises a second rotatable shaft.

[0510] The enclosure may further comprise at least one of: a first sealing member adapted to seal between the enclosure and the first rotatable shaft, and a second sealing member adapted to seal between the enclosure and the second rotatable shaft, and the first and second sealing members may rotate the rotatable shafts.

[0511] The first rotatable shaft may be adapted to be positioned inside the second rotatable shaft, or the second rotatable shaft may be adapted to be positioned inside the first rotatable shaft.

[0512] According to one embodiment, the first force output comprises a first rotatable shaft, the second force output comprises a second rotatable shaft, and the third force output comprises a third rotatable shaft.

[0513] According to one embodiment, the enclosure comprises at least one of: a first sealing member adapted to seal between the enclosure and the first rotatable shaft, a second sealing member adapted to seal between the enclosure and the second rotatable shaft, and a third sealing member adapted to seal between the enclosure and the third rotatable shaft. The first and second sealing members rotate the rotatable shafts.

[0514] The first and second rotatable shafts may be adapted to be positioned inside the third rotatable shaft, or the second and third rotatable shafts may be adapted to be positioned inside the first rotatable shaft, or the first and third rotatable shafts may be adapted to be positioned inside the second rotatable shaft.

[0515] The steerable implant may include at least one implantable battery adapted to power the electric motor.

[0516] The steerable implant may further comprise a receiving unit adapted to receive wireless energy transmitted from outside the patient's body. The receiving unit may be adapted to charge the battery.

[0517] According to one embodiment, the electric motor is an electric motor selected from: an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a radial motor, a three-phase motor, a two or more phase motor, a piezoelectric motor, a bimetallic motor, and a shape memory metal motor.

[0518] The enclosure may comprise a material selected from: a carbon material, a boron material, a mixture of materials, a Peek® material, an alloy of materials, a metallic material, titanium, aluminum, a ceramic material, a polymeric material, polyurethane, and Parylene® coated silicone.

[0519] Any part of different aspects or an aspect, or any part of different embodiments or an embodiment, may all be combined in any possible manner. Any method or any step of a method may be considered as an apparatus description and any apparatus embodiment, and any aspect or part of an embodiment may be considered as a method description, all of which may be combined in any practicable manner, even down to the smallest details. Any detailed description should be interpreted in the broadest sense as a general summary description, and any embodiment or part of an embodiment and any method or part of a method may be combined in any manner.

[0520] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0521] [Figure 1a] FIG. 1a is a schematic diagram of an embodiment of a steerable implant and external unit. [Figure 1b] FIG. 1b is a schematic diagram of an embodiment of a steerable implant and external unit. [Figure 2a] FIG. 2a is a schematic top view of an embodiment of a gear system. [Figure 2b] FIG. 2b is a schematic side view of an embodiment of a gear system. [Figure 2c] FIG. 2c is a schematic top view of an embodiment of a gear system. [Figure 3a] FIG. 3a is a top cross-sectional view of an embodiment of a gear system. [Figure 3b] FIG. 3b is a side cross-sectional view of an embodiment of a gear system. [Figure 3c] FIG. 3c is a schematic top view of an embodiment of a gear system. [Figure 3d] FIG. 3d is a schematic top view of an embodiment of a gear system. [Figure 4] FIG. 4 is a side cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 5] FIG. 5 is an elevated perspective view in section of an embodiment of an implantable hydraulic actuation device. [Figure 6] FIG. 6 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 7] FIG. 7 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 8] FIG. 8 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 9] FIG. 9 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 10a] FIG. 10a shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 10b] FIG. 10b is an exploded, elevated perspective view of one embodiment of an implantable electric motor. [Figure 11a] FIG. 11a shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 11b]FIG. 11b is an exploded elevated perspective view of one embodiment of an implantable electric motor. [Figure 12] FIG. 12 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable manipulation device. [Figure 13a] FIG. 13a is a schematic diagram of an embodiment in which the gear system is made up of multiple gear systems. [Figure 13b] FIG. 13b is a schematic diagram of an embodiment in which the gear system is made up of multiple gear systems. [Figure 14a] FIG. 14a is a schematic diagram of an embodiment in which the gear system is made up of multiple gear systems. [Figure 14b] FIG. 14b is a schematic diagram of an embodiment in which the gear system is made up of multiple gear systems. [Figure 15] FIG. 15 is a side cross-sectional view of an embodiment of a hydraulic operating device with two gear systems. [Figure 16] FIG. 16 is a side cross-sectional view of the left portion of an embodiment of a gear system consisting of two gear systems. [Figure 17] FIG. 17 is an elevated perspective view of a section of an embodiment of a hydraulic operating device comprising two gear systems. [Figure 18a] FIG. 18a shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable hydraulic actuation device. [Figure 18b] FIG. 18b is an exploded side perspective view in cross section of an embodiment of an implantable manipulation device. [Figure 19] FIG. 19 is an elevated perspective view of an embodiment of an implantable manipulation device and an elevated perspective view of a cross section of the implantable manipulation device. [Figure 20] FIG. 20 shows a side cross-sectional view and a top cross-sectional view of an embodiment of an implantable manipulation device. [Figure 21] FIG. 21 is a side cross-sectional view of an embodiment of an implantable hydraulic actuation device with a magnetic coupler. [Figure 22] FIG. 22 is a side cross-sectional view of an embodiment of an implantable manipulation device including a magnetic coupler. [Figure 23]FIG. 23 is a top cross-sectional view of a peristaltic pump. [Figure 24a] FIG. 24a is an elevated perspective view of an implantable manipulation device including a peristaltic pump. [Figure 24b] FIG. 24b is a side cross-sectional view of an implantable manipulation device including a peristaltic pump. [Figure 25a] FIG. 25a is a side cross-sectional view of an implantable manipulation device including a peristaltic pump. [Figure 25b] FIG. 25b is a top cross-sectional view of an implantable manipulation device including a peristaltic pump. [Figure 26] FIG. 26 is an elevated perspective view in section of an embodiment of an implantable hydraulic actuation device. [Figure 27a] FIG. 27a is a side cross-sectional view of an implantable hydraulic operating device in a first state. [Figure 27b] FIG. 27b is a side cross-sectional view of the implantable hydraulic operating device in a second state. [Figure 28a] FIG. 28a is a side cross-sectional view of an implantable hydraulically actuated device. [Figure 28b] FIG. 28b is a top cross-sectional view of an implantable hydraulically actuated device. [Figure 28c] FIG. 28c is a diagram illustrating the reservoir of the implantable hydraulically actuated device. [Figure 29] FIG. 29 is an elevated perspective view of a section of an implantable manipulation device. [Figure 30a] FIG. 30a is an elevated perspective view of the implantable manipulation device in a first condition. [Figure 30b] FIG. 30b is an elevated perspective view of the implantable manipulation device of FIG. 30a in a first condition. [Figure 31a] FIG. 31a is an exploded perspective view of an implantable manipulation device including an initiation resistance delay. [Figure 31b] FIG. 31b is an exploded perspective view of an implantable control device including an initiation resistance delay. [Figure 31c]FIG. 31c is an exploded perspective view of an implantable manipulation device including an initiation resistance delay. [Figure 31d] FIG. 31d is an exploded perspective view of an implantable manipulation device including an initiation resistance delay. [Figure 31e] FIG. 31e is an exploded perspective view of an implantable manipulation device with a coupler. [Figure 32] FIG. 32 is a side cross-sectional view of an implantable operating device positioned under a patient's skin and an external unit for powering the implantable operating device. [Figure 33] FIG. 33 is a side view of a wireless energy transmitter and an implantable wireless energy receiver. [Figure 34] FIG. 34 is a side view of a steerable implant and wireless energy transmitter. [Figure 35a] FIG. 35a shows a side cross-sectional view of a wireless energy transmitter and a side cross-sectional view of a wireless energy transmitter placed under the skin of a patient. [Figure 35b] FIG. 35b is a side cross-sectional view of a wireless energy transmitter and a side cross-sectional view of a wireless energy transmitter placed under the skin of a patient. [Figure 35c] Figure 35c shows an alternative concept of wireless energy transmission. [Figure 36] FIG. 36 is a side view of a steerable implant and wireless energy transmitter. [Figure 37] FIG. 37 is a side view of a steerable implant and wireless energy transmitter. [Figure 38a] FIG. 38a is a schematic side view illustrating the principle for wireless energy transmission through the patient's skin. [Figure 38b] FIG. 38b is a schematic side view illustrating the principle for wireless energy transmission through the patient's skin. [Figure 38c] FIG. 38c is a schematic side view illustrating the principle for wireless energy transmission through the patient's skin. [Figure 39] FIG. 39 is a side view of a steerable implant and wireless energy transmitter. [Figure 40] FIG. 40 is a side view of a steerable implant and wireless energy transmitter. [Figure 41] FIG. 41 is a schematic side view of a steerable implant. [Figure 42] FIG. 42 is a schematic side view of a steerable implant. [Figure 43a] FIG. 43a is a side view of a steerable implant including fixation and distance-creating elements. [Figure 43b] FIG. 43b is a side view of a steerable implant including fixation and distance-creating elements. [Figure 43c] FIG. 43c shows a distance element that constitutes a kit of distance elements. [Figure 43d] FIG. 43d shows another distance element that forms part of a kit of distance elements. [Figure 43e] FIG. 43e shows another distance element that forms part of a kit of distance elements. [Figure 44] FIG. 44 illustrates an embodiment of a steerable implant in which the body engaging portion is an injection device. [Figure 45a] FIG. 45a shows an embodiment of a steerable implant in which the body engaging portion is a compression device. [Figure 45b] FIG. 45b shows an embodiment of a steerable implant in which the body engaging portions are two compression devices. [Figure 45c] FIG. 45c shows an embodiment of a maneuverable implant in which the body engaging portion is a mechanical body engaging portion.

[0522] [Detailed description of the drawings] Hereinafter, a detailed description of embodiments of the present invention will be given with reference to the accompanying drawings. It should be understood that the drawings are for illustrative purposes only and do not limit the scope of the present invention in any way. Therefore, any reference to directions such as "up" or "down" merely refers to the direction shown. It should be noted that features having the same reference numbers have the same functions, and therefore, unless otherwise clear, a feature in one embodiment can be exchanged for a feature from another embodiment having the same reference number. Therefore, it should be understood that the descriptions of features having the same reference numbers are complementary to each other in explaining the basic concept of the feature and show these features in multiple aspects.

[0523] A steerable implant should be understood to be any implant that may be manipulated to perform a function with respect to a patient's body, including changing the size and / or shape of a portion of the implant, delivering active or inactive substances to a patient's body, applying electrical stimulation to a portion of a patient's body, sensing physical or functional parameters of the steerable implant and / or physiological or physical parameters of the patient, communicating with an external unit outside the patient's skin and receiving or transmitting energy from the external unit to the steerable implant. The steerable implant may be, for example, a pacemaker unit, an external cardiac compression device, a left ventricular assist device (LVAD) device, a device to assist the pumping function of the heart such as a steerable prosthetic heart valve, an implantable drug delivery device such as an implantable device for delivering insulin or a chemotherapy agent, for example: contracting the intestine to treat anal incontinence, contracting the intestine to manage a stoma, contracting the urethra to treat urinary incontinence, contracting the bile duct to treat gallbladder insufficiency, contracting the fallopian tubes for fertility control, contracting the vas deferens for sexual performance control, constricting blood vessels to increase blood volume in erectile tissue, or a hydraulic, mechanical, and / or electroconstrictive implant for compressing or suppressing an aneurysm. The steerable implant may also be a steerable implant for treating obesity, such as a steerable volume filling device for reducing stomach volume, a steerable gastric band for restricting the passage of food, or a steerable implant for stretching the stomach wall to create a feeling of fullness. The steerable implant may be a steerable device for treating gastroesophageal reflux disease (GERD), a steerable breast implant, or a steerable cosmetic implant such as an implant for adjusting or replacing any bony part of the body. Additionally, the implant may replace an organ or part of an organ, or the function of an organ may be adjusted or replaced.Other examples of implants are implants that treat impotence by implanted drug delivery, implants that affect blood flow, vascular treatments that may include thrombus removal, implants that affect fertility and / or infertility, or implants that are adapted to move fluids inside the body. The above-listed examples of steerable implants should be seen as examples that in no way limit the possible application areas of steerable implants.

[0524] A body engaging portion should be understood as any element or portion of the implant that is directly or indirectly connected to the patient's body and that is operable to perform a function with respect to the patient's body. The function may be, for example, to push and / or pull a part of the patient's body, to deliver a substance to the patient's body, to collect a sample from the patient's body, to electrically stimulate a part of the patient's body, and / or to fill or empty an implantable volume filling device with a hydraulic fluid.

[0525] The physical or functional parameter of the steerable implant may be, for example, an electrical parameter such as voltage, current, or impedance, or a parameter related to a fluid such as pressure, flow rate, temperature, volume, weight, or viscosity. The parameter could relate to energy received at the steerable implant, energy delivered to the patient's body, fluid received at the steerable implant, fluid delivered to the patient's body, force applied to the patient's body, or time elapsed since a procedure was performed relative to the patient's body.

[0526] The physiological or physical parameter of the patient may be, for example, a parameter related to the patient's body pressure, blood flow, blood saturation, a parameter related to an ischemic marker, the patient's body temperature, a parameter related to muscle activity, or a parameter related to the activity of the digestive system.

[0527] In most instances, the enclosures referred to herein are adapted to separate components of the operable implant from bodily fluids during implantation. However, enclosures may also be used to contain fluids or to separate fluids used by the operable implant from other components of the operable implant. The enclosure may be made from one or a combination of carbon-based materials (such as graphite, silicon carbide, or carbon fiber materials), boron materials, polymeric materials (such as silicone, Peek®, polyurethane, UHWPE, or PTFE), metallic materials (such as titanium, stainless steel, tantalum, platinum, niobium, or aluminum), ceramic materials (such as zirconium dioxide, aluminum oxide, or tungsten carbide), or glass. In all cases, the enclosure should be made from a material with low permeability so that fluid migration through the enclosure walls is prevented.

[0528] The steering device of the steerable implant may include an electric motor for converting electrical energy into mechanical work. The electric motor may be, for example, an alternating current (AC) electric motor, such as a three-phase electric motor (which may be controlled using a variable frequency drive), a direct current (DC) electric motor, a linear electric motor, an AC or DC axial electric motor, a piezoelectric motor, a bimetallic motor, or a shape memory metal motor.

[0529] Generally, described herein are steerable implants including an implantable body-engaging portion and an implantable manipulation device, as well as medical systems including components of the steerable implant. The implantable manipulation device may be adapted to manipulate the body-engaging portion electrically, mechanically, or hydraulically and may be powered by means of wireless energy transmission from outside the patient's body or by an implantable battery adapted to store electrical energy within the patient's body. The manipulation device may include an electric motor for converting electrical energy into mechanical work (force * distance), which may be connected to one or more gear trains for varying the speed and / or force / torque and / or direction of the applied force. The steerable implant may further include a communication unit for communicating with portions of the steerable implant, other steerable implants, and / or an external unit. Communication with an external unit may include control signals from the external unit for controlling the steerable implant or feedback signals from the steerable implant, which may be sensor parameters, such as physiological or physical sensor parameters related to the status of the patient's body, or physical or functional parameters related to the status of the steerable implant.

[0530] 1a and 1b show schematic diagrams of a medical system including a steerable implant 100 adapted to be implanted in a patient's body and an external unit 200 for energizing and / or communicating with the steerable implant 100. The schematic diagrams of FIGS. 1a and 1b show examples of components that may be included in the steerable implant 100 and the external unit 200, respectively, and the embodiments should not be viewed as complete, just as the components shown in the figures are not considered essential for the invention to function.

[0531] FIG. 1a shows a steerable implant 100 implanted subcutaneously beneath a patient's skin S. The steerable implant 100 includes a manipulation device 110 including a receiving unit 120 adapted to receive wireless energy or information from an external unit 200. The wireless energy may be in the form of an electromagnetic field transmitted between a coil of the external unit 200 and a coil of the steerable implant 100, with the coil of the external unit 200 acting as electrical conductors inductively coupled to each other, forming a transformer-like circuit for transmitting alternating current electrical energy signals. In alternative embodiments, the wireless energy may take the form of a moving magnetic field magnetically coupled to a movable structure of the implantable manipulation device 100 that includes a magnet or magnetic material, causing the movable structure of the steerable implant to move along the moving magnetic field generated by the external unit (e.g., as further described with respect to FIGS. 32-39 ). The receiving unit 120 may further be a coupling unit adapted to receive wireless energy both in the form of a moving magnetic field that affects the movable structure of the operating device and as wireless energy that generates an electric current in the implantable operating device 110 for operating components that consume electrical energy or for charging batteries (e.g., 190a, 190b) for indirectly powering components of the operable implant 100 that consume electrical energy.

[0532] In the embodiment shown in FIG. 1a, the external unit 200 includes an external drive unit 210 for generating the above-mentioned rotating magnetic field using an external electric motor 230 that rotates an external portion of the electromagnetic coupling 220 that includes a rotatable structure including a magnet or electromagnet, whereby rotation of the rotatable structure by operation of the external electric motor 230 generates a moving magnetic field (e.g., as further disclosed with respect to FIGS. 35-36).

[0533] The manipulation device 110 of the maneuverable implant 100 further includes a distance element 110c adapted to create a distance between a first unit 110a of the manipulation device 110, which includes the main part of the components of the manipulation device 110, and a second unit 110b of the manipulation device 110, which includes the receiving unit 120. The distance can be such that the receiving unit 120 is not substantially affected by components of the first unit 110a, which may be components including magnetic or magnetizable materials that may disrupt the magnetic and / or electromagnetic fields that transmit wireless energy between the transmitting unit 220 and the receiving unit 120.

[0534] The distance element 110c connecting the first and second units 110a, 110b may include electrical leads for transmitting energy and / or information from the second unit 110b to the first unit 110a, and / or a mechanical power transmission member adapted to transmit mechanical power from the second unit 110b to the first unit 110a. The mechanical power transmission member may be, for example, at least one of a rotating shaft for transmitting rotational power, a flexible member for transmitting rotational power, a Bowden cable, a wire, a belt, a rod, a worm gear, or a gear adapted to change the direction of a rotational power received at the receiving unit by approximately 90 degrees, such as a Bevel gear. The operating device of FIG. 1 further optionally includes an electric motor 130 adapted to convert electrical energy into mechanical work. The electric motor 130 may receive electrical energy directly from the external unit 200 or may receive electrical energy stored in an implantable battery 190. The electric motor 130 may be omitted in embodiments in which a movement force transmitted directly from the external drive unit 210, such as a rotational movement force, is received at the receiving unit 120. The electric motor 130 may be, for example, an electric motor 130 selected from: an alternating current (AC) electric motor, a direct current (DC) electric motor, a linear electric motor, an axial electric motor, a piezoelectric motor, a polyphase motor such as a three-phase motor, a bimetallic motor, and a shape memory metal motor.

[0535] According to the schematic shown in Fig. 1a, a force output of electric motor 130 is connected to a force input of gear system 140. Gear system 140 is adapted to receive mechanical work having a first force and a first speed and to output mechanical work having a different second force and a different second speed, whereby high-speed motion provided by electric motor 130 and / or a direct connection with receiving unit 120 is transferred to low-speed motion as the force increases.

[0536] Gear system 140 may include a gear system having a configuration such as any of the gear systems herein, such as the gear systems disclosed with respect to FIGS. 2-16 . In alternative embodiments, it is contemplated that gear system 140 may include a transmission system of some other configuration, such as a conventional gear system, a worm gear system, or a belt transmission system. In the embodiment shown in FIG. 1 a, gear system 140 is connected to a connecting member 182 that connects gear system 140 of manipulation device 110 to a body engagement portion 180 for manipulating the body engagement portion. In the embodiment shown in FIG. 1 a, the connection between gear system 140 and body engagement portion 180 includes a mechanical connecting member 181, such as a rotating shaft, rod, or flexible member for transmitting rotational force, such as a Browden cable.

[0537] The manipulation device may further include a generator 170 for generating an electrical circuit (further described with respect to FIGS. 36-4). The configuration of the maneuverable implant 100 is such that the generator 170 is disposed between the receiving unit 120 and the gear unit 140, such that the generator 170 receives forces at high speed. In alternative embodiments where there is no direct mechanical connection between the receiving unit 120 and the body engaging portion 180, the gear system 140 may be omitted entirely.

[0538] The steerable implant may include at least one implantable battery 190a, 190b that could be used to operate or control the steerable implant. The battery 190a, 190b could be used in combination with direct drive from the external drive unit 210. As an example, a patient may use direct drive to operate the steerable implant at home and use battery power when away from home or in an emergency situation. The battery 190a, 190b could be adapted to power the operation of the steerable implant 100 and / or to power the control unit and / or communication unit. The battery 190a, 190b could be adapted to be charged either by a receiving unit receiving wireless energy or by the implantable generator 170. The battery could be replaced by any form of energy storage device, such as a capacitor.

[0539] 1a, the steerable implant 100 further includes at least one implantable battery 190a, 190b, which may be located in a separate unit, e.g., battery 190a, or which may be located in the steering device 110, e.g., battery 190b. The steerable implant 100 may include leads 122 connecting the batteries 190a, 190b to the receiving unit 120 so that wireless energy received by the receiving unit 120 can be stored in the batteries 190a, 190b, or leads 172 connecting the batteries 190a, 190b to the electric generator 70 so that current generated by the generator 170 can be stored in the batteries 190a, 190b. The at least one battery 190a, 190b may be adapted to provide power to at least one of the steerable implant 100 and a control system 195 for controlling the electric motor 130. A first lead 192 connects the batteries 190a, 190b to a control system 195, and a second lead 132 connects the electric motor 130 to the batteries 190a, 190b.

[0540] The control unit 195 may include elements for controlling the steerable implant 100, which may include controlling the electric motor 130, for example, by adjusting the frequency of the alternating current supplied to the electric motor or by adjusting the voltage supplied to the electric motor 130. The control unit 195 may be adapted to receive sensor inputs from one or more sensors of the steerable implant 100, which may be sensors adapted to monitor physical parameters of the steerable implant 100 or physiological parameters of the patient. In some embodiments, the control unit 195 may be adapted to control a hydraulic operating device, for example, by controlling the actuation of a valve or a movable wall portion of a reservoir. The control unit 195 may include a communication unit for communicating with the external unit 2000, in which case the receiving unit 120 may further include a unit for transmitting information, whereby physical parameters of the steerable implant and / or physiological parameters related to the patient's body may be communicated between the steerable implant 100 and the external unit 200. If necessary, the control unit may include a rectifier circuit to convert the alternating current received by the receiving unit to a direct current suitable for powering elements of the steerable implant 100 or for charging at least one battery 190 a, 190 b of the steerable implant 100. To process communications, information, and / or data, the control unit 195 may further include a demodulator and a microprocessor. The demodulator may demodulate signals transmitted from the external unit 200, and the microprocessor may decode and / or interpret received signals. The receiving unit 120 of the steerable implant and the transmitting unit 220 of the external unit 200 may be adapted to communicate using, for example, radio, IR (infrared), ultrasound, magnetic, inductive, or capacitive signals.

[0541] The steerable implant 100 or parts of the steerable implant may be surrounded by an enclosure during implantation to separate components of the steerable implant 100 from bodily fluids. However, an enclosure may also be used to contain fluids, for example, in a reservoir, or to separate fluids used by the steerable implant 100, such as lubricating fluids for a gear system, from other components of the steerable implant 100. The enclosure may be made from a non-metallic, non-magnetic material so as not to affect electromagnetic energy transmission between the external unit 200 and the steerable implant 100. The enclosure may be made from one or a combination of: a carbon-based material (such as, for example, graphite, silicon carbide, or carbon fiber material), a boron material, a polymeric material (such as, for example, silicone, Peek®, polyurethane, UHWPE, or PTFE), a metallic material (such as, for example, titanium, stainless steel, tantalum, platinum, niobium, or aluminum), a ceramic material (such as, for example, zirconium dioxide, aluminum oxide, and tungsten carbide), or glass. In any example, the enclosure should be made from a material with low permeability so that migration of fluids through the enclosure wall is prevented.

[0542] Referring now to the external unit 200, the external unit 200 is adapted to control and / or communicate with the steerable implant 100. The external unit 200 may include an external drive unit 210 that may be adapted to generate a moving magnetic field adapted to magnetically couple with the magnet or magnetic material of the receiving unit 120 of the steerable implant 100, such that generation of the moving magnetic field outside the patient's body manipulates the steerable implant 100 via magnetic coupling between the external drive unit 210 and the movable structure of the steerable implant 100. The moving magnetic field may be generated by an electric motor 230 connected to a movable structure including at least one magnet, which may be an electromagnet or a permanent magnet. In an alternative embodiment, the moving magnetic field is generated by modifying the magnetic field, such as by modifying the current to the electromagnet, such that the force provided by the electromagnet flows in an alternating current, thus causing reciprocating motion of the magnetic or magnetizable material. Generation of the moving magnetic field is further described with respect to FIGS. 32-39.

[0543] The external unit 200 may include at least one rechargeable or disposable battery 290, which may be directly powered by connection to a power outlet of a power grid or may be connected using a conduit 292 to the drive unit 210 for powering the electric motor 230 and / or electromagnet. The external unit 200 may also include an external control / communication unit for communicating with the control / communication unit 195 of the steerable implant 100. The external control / communication unit may be adapted to receive control signals from the steerable implant and to adjust control of the external unit 200 in response to the received control signals.

[0544] Figure 1b shows an embodiment of a steerable implant 100 that should be seen as an alternative to the embodiment illustrated in Figure 1a, with the difference being that the embodiment of Figure 1b is a specific hydraulic embodiment adapted to operate a hydraulically operable body engaging portion 180' that is adapted to be connected to an operating device 110 by means of a connecting portion 182 that includes at least one conduit for transmitting hydraulic fluid from the operating device 110 to the hydraulically operable body engaging portion 180'.

[0545] The operating device 110 of the embodiment shown in FIG. 1b includes a hydraulic pump 150 connected to a reservoir 160 for holding hydraulic fluid. The reservoir 160 may include at least one movable wall portion 163, which may constitute the hydraulic pump 150 (e.g., by an operable movable wall as disclosed with reference to FIG. 4 or FIG. 5). In alternative embodiments, the hydraulic pump 150 may be, for example: a valveless pump, a pump including at least one valve, a peristaltic pump, a membrane pump, a gear pump, or a bellows pump. The hydraulic pump 150 is operated by connection to either an implantable electric motor 130 or a movable structure adapted to be operated from outside the patient's body. The connection between the hydraulic pump 150 and the electric motor 130 or the movable structure operates via a gear system 140 adapted to convert high-speed, low-force motion into low-speed, high-force motion.

[0546] The hydraulic body engaging portion 180' may include, for example, a hydraulic contraction or restraint device, or a volume filling device.

[0547] 2a shows one embodiment of an implantable gear system 140 for operation in the operating device 110. The gear system 140 is adapted to receive a mechanical action having a first force and a first speed and to output a mechanical action having a second, different force and a second, different speed. The gear system 140 includes an input 142 connected to an operable element 143′ adapted to engage a first gear 144 having the shape of a hollow cylinder with a first number of teeth 144t, e.g., 160, on its outer circumference, and a second gear 145 having the shape of a hollow cylinder with a greater number of teeth 145t, e.g., 162, on its inner surface. The manipulable element 143' is adapted to engage the inner side 144a of the first gear 144, such that the outer side 144b of the first gear 144 is pressed against the inner side 145a of the second gear 145 such that the teeth 144t of the first gear 144 are interengaged with the teeth 145t of the second gear 145 at a position P1 separated from each other by a position where the teeth do not interengage (e.g., position P2). Operation of the manipulable element 143' advances position P1, thereby generating relative rotation between the first gear 144 and the second gear 145. In the embodiment shown in FIG. 2a, the second gear 145 includes two more teeth 145t than the first gear 144, causing the first gear 144 to rotate 2 / 160 or 1 / 80 of a revolution for each revolution performed by the manipulable element 143′, resulting in an 80-fold transmission, i.e., the output (149 in FIG. 2b) provides a force that is 80 times slower and 80 times stronger, thus increasing the force that can be exerted by, for example, an electric motor, by 80 times. In the embodiment shown in FIG. 2a, the manipulable element slides radially against the inner surface of the first gear 144. It is further contemplated that a lubricating fluid may be present in the gear system to reduce friction, and that the surfaces on which the manipulable element 143′ or manipulable implant 143′ slide may comprise a self-lubricating material, such as Graphalloy, Nyliol, or PTFE.

[0548] 2b shows gear system 140 in cross-sectional side view, and in this embodiment, gear system 140 includes a third gear 146 having an inner side 146a that includes the same amount of teeth 146t as the outer side 144b of first gear 144. The teeth 146t of third gear 146 are adapted to interengage with the teeth of first gear 144 such that third gear 146 rotates relative to second gear 145 with the interengaged position (P1 in FIG. 2a). Third gear 146 is connected to an output 149 of gear system 140 by a radially extending connecting structure 147 for transmitting power from third gear 146 to output 149.

[0549] FIG. 2c shows an alternative embodiment of the medical device, in which a manipulable element 143″ is adapted to engage the inner side 144a of a first gear 144 in two diametrically opposed positions. The manipulable element 143″ deflects the first gear 144, giving it an elliptical shape in axial cross section. The manipulable element 143″ is adapted to maintain the deflected first gear 144′, so that the teeth of the first gear 144 interengage with the teeth of the second gear 145 in two angularly spaced, diametrically opposed positions P1′ and P1″. The two positions P1′ and P1″ are separated from each other by positions where the teeth do not interengage, for example, two positions P2′ and P2″. 2c, the difference in the number of teeth between the first gear 144 and the second gear 145 needs to be divisible by 2 so that when the teeth of the first and second gears 144, 145 interengage at two positions, the first gear 144 will deflect equally, resulting in an oval shape, so that the different number of teeth can be evenly distributed in the two areas between the first and second gears 144, 145 with positions where the teeth of the first and second gears 144, 145 do not interengage. Mathematically, this can be expressed as if the first gear has x teeth, then the second gear needs to have x+n*2 teeth, and the transmission provided by the gear system 140 is then calculated as transmission=x / (x+n*2). To provide uniform deflection of the first gear 144, the operable element may be an operable element adapted to deflect the first gear 144 such that the first and second gears 144, 145 are interengaged in three, four, or more positions. In alternative embodiments (not shown), the difference in the number of teeth between the first gear 144 and the second gear 145 should correspond to the number of contact areas. In a more general mathematical formula, the relationship can be expressed as the second gear should have x+n*m number of teeth, where n is a constant selected based on the desired transmission and m is the number of positions where the teeth of the first and second gears interengage.

[0550] FIG. 3 a illustrates an embodiment in which the operable element includes planetary gears, where the input 142 includes a central gear connected to first and second planetary gears 143′″a, 143′″b, such that the teeth of the first gear 144 interengage the teeth of the second gear 145 at first and second positions P1′, P1″. The first and second planetary gears 143′″a, 143′″b also deflect the first gear 144. Similar to what was described above with reference to FIG. 2 c, to ensure that the first gear 144 deflects equally and forms an oval shape as a result, the difference in the number of teeth between the first gear 144 and the second gear 145 needs to be divisible by two, so that different numbers of teeth can be evenly distributed in two areas between the first and second gears 144, 145 with positions where the teeth of the first and second gears 144, 145 do not interengage.

[0551] The planetary gear set of FIG. 3 a further increases the transmission of the gear system by the transmission resulting from the difference in the number of teeth between the central gear 142 and the planetary gear sets 143′′′a, 143′′′b, i.e., the total transmission of the gear system 140 is equal to the transmission provided by the planetary gear set plus the transmission provided by the difference in the number of teeth between the first gear 144 and the second gear 145.

[0552] Figure 3b shows gear system 140 in a cross-sectional side view. In the embodiment shown in Figure 3b, gear system 140 also includes a third gear 146 similar to the third gear described with reference to Figure 2b, such that third gear 146 rotates with the first gear and the interengaged positions P1", P1". Third gear 146 is connected to an output 149 of gear system 140 by a radially extending connecting structure 147 for transmitting power from third gear 146 to output 149.

[0553] Figure 3c shows an alternative embodiment of the planetary gearing in which the planetary gearing only includes one planetary gear 143'''a connected to the central gear 142. The embodiment functions similarly to the embodiment described with reference to Figure 2a, with the difference being that an additional transmission is provided by the planetary gearing.

[0554] FIG. 3d shows an embodiment in which the planetary gear mechanism includes three planetary gears 143'''a, 143'''b, 143'''c, each of which deflects a first gear 144' such that the first gear 144 is pressed against a second gear 145 at three angularly spaced contact locations P1', P1'', P1''', substantially 120 degrees apart from each other. Similar to the other described embodiments, the difference in the number of teeth between the first gear 144 and the second gear 145 must correspond to the number of contact points; i.e., in the embodiment shown in FIG. 3d, the difference must be divisible by three so that the first gear 144 is evenly deflected.

[0555] In an alternative embodiment, the gears of the planetary gear set in any of the embodiments described with reference to Figures 2a-3d are toothless gears and therefore only use friction to interengage with each other, so that the central gear is connected to and drives the planetary gear set by a friction-based connection.

[0556] The gear system 140 in any of the embodiments of FIGS. 2a-3d can be made of, for example, a metal material, a plastic material, or a ceramic material. In one embodiment, the gear system is made of a non-metallic and / or non-magnetic material, so that the gear system does not affect energy transmission to the implantable energy receiver. The gear system may be lubricated with a biocompatible lubricant, such as hyaluronic acid, and may therefore be disposed inside a reservoir adapted to hold hydraulic fluid, which may also act as a lubricant. The gear system may be enclosed by an enclosure to prevent bodily fluids from affecting the gear system and / or human tissue ingrowth in the gear system and / or leakage of hydraulic fluid and / or lubricating fluid. The enclosure may be non-metallic and / or non-magnetic, so that the material of the enclosure does not affect the ability to transmit wireless energy to the wireless energy receiver of the steerable implant. The gear system may be enclosed separately or together with the electric motor of the manipulation device or additional components of the manipulation device.

[0557] FIG. 4 shows an embodiment of an implantable manipulation device 110 of a maneuverable implant 100 that includes a gear system 140, as further described with respect to FIG. 3a. The gear system 140 includes a force input 142 that could be connected to, for example, an electric motor adapted to convert electrical energy into mechanical work (such as any of the electric motors described herein). The force input 142 is connected to planetary gears 143'''a, 143'''b, which in turn manipulate a first gear 144 of the gear system 140 (as further described with respect to FIG. 4). A force output 149 is connected to the gear system 140 via a third gear 146 of the gear system 140 and a radially extending connecting structure 147. 4, the force output 149 is a hollow shaft with internal threads (not shown) adapted to engage the external threads of the threaded member 441, such that the interaction between the hollow shaft 149 and the threaded member 441 converts the radial rotational force generated by operation of the gear system 140 into a linear axial reciprocating force. The threaded member 441 is connected to a radially extending engagement member 444 that, in the embodiment shown in FIG. 4, is adapted to engage a reservoir 160 adapted to contain hydraulic fluid. In the embodiment shown in FIG. 4, the reservoir 160 is a donus-shaped reservoir 160 adapted to be compressed, thereby reducing the volume within the reservoir and forcing hydraulic fluid from the reservoir 160 into the fluid conduit 162 and further into the hydraulically-operable body engaging portion 180 of the operable implant 100.

[0558] The operating device 110 further includes a seat portion 445 that functions as an anvil in connection with the compression of the reservoir 160 and simultaneously functions as an enclosure that at least partially surrounds the gear system 140. The seat portion 445 connects to a portion of the enclosure 442 that is adapted to surround the force output 149 and the threaded member 441, thereby sealing the threaded member 441 and the force output 149 from bodily fluids. The connection of the seat portion 445 to the portion of the enclosure 442 that encloses the output 149 and the threaded member 441 eliminates the need for a seal between the seat portion 445 and the output 149, facilitating operation of the gear system 140 and providing a hermetic enclosure of the gear system 140. The portion of the enclosure 442 that surrounds the force output 149 and the threaded member 441 includes a pleated section 443 that functions as a bellows. The pleated section 443 is adapted to allow for fibrous tissue ingrowth without affecting the mobility of the pleated section 443. The reservoir 160 is preferably made from a resilient and / or elastic material, such as silicone, and may be covered with a Parylene® coating to better resist stress and wear induced by compression of the reservoir 160. The force input 142 may be sealed to the bottom of the enclosure, or alternatively, an operating device, such as an electric motor, may be located in the same sealed environment, thereby eliminating the need for a seal between the force input 142 and the enclosure.

[0559] FIG. 5 illustrates an embodiment of the operating device 110 in which the gear system is disposed inside a reservoir 160′, such that the reservoir 160′ at least partially surrounds the gear system 140. The embodiment illustrated in FIG. 5 further includes an electric motor 130 connected to a force input of the gear system 140. Power transmission between the electric motor 130 and the gear system 140 may involve a shaft exiting a first enclosure surrounding the electric motor 130 and entering a second enclosure surrounding the gear system 140 inside the reservoir 160′, in which case both enclosures must be rotatably penetrated by the shaft, creating friction at the seals. In an alternative embodiment, the enclosure surrounding the electric motor 130 and the enclosure surrounding the gear system 140 are connected, resulting in a single enclosed space surrounding both the gear system 140 and the electric motor 130, in which case the force-transmitting shaft does not need to be sealed. Enclosure 445' is thus sealingly connected to the enclosure surrounding electric motor 130. Force output 149 connecting threaded member 441 functions in a similar manner to that described with respect to Figure 4, except that threaded member 441 is directly connected to the movable wall portion of reservoir 160' such that the volume of reservoir 160' is changed by threaded member 441, moving the movable wall portion. Reservoir 160' is connected to fluid conduit 162' such that fluid in reservoir 160' is transported from reservoir 160' through fluid conduit 162' to the hydraulically operable body-engaging portion of the operable implant, whereby compression of reservoir 160' indirectly exerts a force on a portion of the patient's body.

[0560] In the embodiment shown in Figure 5, the manipulable elements 143'''a, 143'''b are connected by the force input and the first gear using friction, i.e., the manipulable elements 143'''a, 143'''b do not include teeth.

[0561] In some embodiments, placing the gear system inside the reservoir allows the gear system 140 to be lubricated with hydraulic fluid contained in the reservoir 160. The fluid may be a biocompatible lubricating fluid such as hyaluronic acid, an isotonic fluid, or a glycerol-based fluid.

[0562] The basic principles of gear system 140 described above may be implemented in combination with any of the operable implants herein. Advantages of gear system 140 include: low friction, high transmission in a compact format, good precision, low noise, and gear system 140 may function without lubrication.

[0563] FIG. 6 shows an embodiment of an implantable manipulation device 100 for manipulating a steerable implant. The manipulation device 110 includes an implantable electric motor including a coil 132 and a magnet 133. Energizing the coil 132 generates a magnetic field by current flow in the coil winding 132′ and the coil core 132″, magnetically coupling the magnet 133. The magnet 133 is affixed to a rotatable structure 135, such that sequential energizing of the coil 132 propels the magnet 133 and rotates the rotatable structure 135. The magnetic coupling between the coil 132 and the magnet 133 is arranged around the periphery of the manipulation device 110 so that the torque generated should be as large as possible. The rotatable structure 135 includes a radially extending portion 147 that transmits the force generated by the coil 132 and the magnet 133 around the periphery of the manipulation device 110 to a force input 142 of a gear system that connects the manipulable elements 143′″a, 143′″b. The operable element engages and biases the first gear 144 of the gear system 140 such that the outside of the first gear 144 is pressed against the inside of the second gear 145, causing the teeth of the first gear 144 to interengage with the teeth of the second gear 145 at two positions separated by a position where the teeth are not interengaged. Because the second gear 145 has a greater number of gears on its inner surface than the first gear 144, operation of the operable elements 143'''a, 143'''b causes relative rotation between the first gear 144 and the second gear 145 by advancing the interengaged position.

[0564] The gear system further includes a third gear 146 having the shape of a hollow cylinder. The inside of the third gear 146 includes the same amount of teeth as the outside of the first gear 144, and the teeth of the third gear 146 are adapted to interengage the teeth of the first gear 144 so that the third gear 146 rotates relative to the second gear 145 with at least one interengaged position. The third gear 146 is connected to a radially extending portion 147 that connects the third gear 146 to a centrally located output 149 of the gear system.

[0565] First gear 144, second gear 145, and third gear 146 all have a smaller diameter than the portion of rotatable structure 135 to which magnet 133 is fixed and the portion of enclosure 111c to which coil 133 is fixed. The gear system is therefore located inside the electric motor, such that coil 132 and magnet 133 partially cover the gear system in the axial direction. The electric motor and gear system being located in the same axial plane allows manipulation device 110 to be enclosed within a thin enclosure 111, making manipulation device 110 suitable for, for example, subcutaneous implantation.

[0566] The embodiment of the operating device described with reference to FIG. 6 includes a threaded member in the form of a worm shaft 441′ having a first helical groove in a first direction and a second helical groove in a second direction. The worm shaft 441′ is engaged by an operable portion 446, which in turn is connected to a radially extending engagement member 444 adapted to compress the reservoir 160. Rotation of the worm shaft 441′ causes the operable portion 446 to reciprocate in the helical grooves by switching from engaging the first helical groove to engaging the second helical groove at the end portion of the worm shaft 441′. The worm shaft 441′ allows the reservoir 160 to be compressed and expanded by an electric motor that always rotates in the same direction, facilitating control and allowing optimization of the motor, seals, and bearings for a particular direction of rotation.

[0567] 6, the coil 132 is disposed in the sealed space and further comprises an energy supply unit in the form of a battery 190 adapted to power the electric motor, and a control system 195 adapted to control the electric motor and / or additional operable elements of the operable implant. The battery 190 and / or control system 195 are connected with leads 192 connecting the battery 190 and / or control system 195 to a wireless energy receiver and / or a wireless communication unit and / or an additional battery 190 for supplying additional energy to the operating device. In an alternative embodiment in which the electric motor is powered directly from the wireless energy receiver, the battery 190 is only adapted to power the control system 195.

[0568] Figure 7 shows a control unit 20 and an operating device 110 similar to the control unit 20 and operating device 110 shown with reference to Figure 6, with the difference that in the operating device of Figure 7 the magnet 133 is fixed to a rotatable structure 135 which includes a radially extending portion 147 adapted to transmit force from the periphery of the rotatable structure 135 to the centre of the rotatable structure 135 below the electric motor and gear system. The radially extending portion 147 transmits force to an input 142 of the gear system which in turn engages operable elements 143'''a, 143'''b.

[0569] In the embodiment of FIG. 7, the coil 132 is disposed and sealed within a separate coil enclosure 131, thereby further isolating the coil 132 from the patient's body fluids and / or from lubricating fluid used in the gear system and / or from hydraulic fluid adapted to transmit force from the reservoir 160 through the fluid conduit 162 to the hydraulically operable body-engaging portion.

[0570] Figure 8 further illustrates an alternative embodiment of the control unit 20 and the manipulation device 110, similar to the control unit 20 and the manipulation device 110 illustrated with reference to Figures 6 and 7. In the embodiment illustrated with reference to Figure 8, a rotatable structure 135 including a magnet 133 is adapted to be propelled by a coil 132 attached to a portion 111c of an enclosure 111 having a circumferential diameter larger than the diameter of the rotatable structure 135 to which the magnet 133 is attached. The coil 132 is thus positioned radially outward of the magnet 133 and is sealed by the coil enclosure 131 from the rest of the manipulation device 110 and from the patient's body fluids. The rotatable structure 135 is connected to an input 142 at the center of the rotatable structure, which input 142 is also adapted to engage manipulable elements 143'''a, 143'''b of a gear system (as described in more detail in other embodiments herein). The embodiment shown in FIG. 8 places all rotating parts of the operating device 110 in the center of the operating device 110 which further isolates the rotating parts of the operating device 110, so that noise caused by the moving parts is less likely to propagate through the enclosure 111 of the operating device 110 and the patient's body.

[0571] FIG. 9 further illustrates an alternative embodiment of the control unit 20 and the manipulation device 110, similar to the control unit 20 and the manipulation device 110 illustrated with reference to FIGS. 6, 7, and 8. In FIG. 9, the magnet 133 is integrated into the maneuverable elements 143'''a, 143'''b of the manipulation device 110. The maneuverable elements 143'''a, 143'''b are rotatably connected to a connecting structure 143c, which engages and deflects the first gear 144 of the gear system as the magnetic attractive force generated by the coil sequentially attracts the magnet 133, which propels the maneuverable elements 143'''a, 143'''b. The portion of the maneuverable elements 143'''a, 143'''b to which the magnet 133 is connected has a larger diameter than the portion of the maneuverable elements 143'''a, 143'''b that engages the first gear 144 of the gear system, such that the magnet 133 can be positioned in close proximity to the coil 132. The distance between the coil 132 and the magnet 133 may be, for example, one of 50 μm, 100 μm, 200 μm, 400 μm, 600 μm, 800 μm, 1 mm, 2 mm, 3 mm, or 5 mm, depending on the overall dimensions of the operating device 110 and the magnetic force exerted by the coil 132.

[0572] 10a and 10b show an embodiment of a manipulation device similar to the embodiment shown with respect to FIGS. 6-9. The difference between the embodiments of FIGS. 6 and 10a is that the embodiment of FIG. 10a includes an axial-type electric motor 130′ adapted to propel a gear-system force input 142. The axial-type electric motor 130′ includes a set of coils 132 distributed circularly around the axis of rotation of the electric motor 130′ and a set of magnets 133 connected to a radially extending rotatable structure 135 axially overlapping the magnets 133, such that sequential energization of the coils 132 magnetically propels the magnets 133 axially, rotating the rotatable structure 135 connected to a gear-system force input 142 that is connected to manipulable elements 143′″a, 143′″b, which in the embodiment shown in FIG. 10a are planetary gears 143′″a, 143′″b. The gear system and the axial-type electric motor 130' are coaxially positioned along the axis of rotation of the electric motor 130'.

[0573] The operable elements 143'''a, 143'''b engage a first gear 144 of the gear system and bias the first gear 144, which presses the outside of the first gear 144 against the inside of the second gear 145, causing the teeth of the first gear 144 to interengage with the teeth of the second gear 145 at two positions separated by a position where the teeth are not interengaged. Because the second gear 145 has a greater number of gears on its inner surface than the first gear 144, operation of the operable elements 143'''a, 143'''b causes relative rotation between the first gear 144 and the second gear 145 by advancing the interengaged position.

[0574] 4 and 5. The embodiment of FIG. 10a further includes an enclosed space below the axial electric motor 130′ that houses a battery 190 adapted to power the axial electric motor 130′ and a control unit 195 adapted to control the axial electric motor 130′ and / or additional operable elements of the operable implant. The battery 190 and / or control unit 195 are in communication with leads 192 that connect the battery 190 and / or control unit 195 to the coil 132 to, in turn, energize the coil 132 and thereby operate the axial electric motor 130′.

[0575] FIG. 10b shows a rotatable structure 133 to which the magnets 133 and the force input 142 of the gear system are fixed, the rotatable structure 135 being a non-metallic disk, so that the individual magnets 133 are not affected by their being fixed to the rotatable structure 135. FIG. 10b also shows coils 132 including coil windings 132' and coil cores 132'' connected to a core structure 132s adapted to position the magnets 133 and serve as magnetic interconnections between the cores 132'' of each of the coils 132. The coils 132 are circularly distributed around the rotation axis of the manipulation device 110 and connected to the core structure 132s, so that the helices of the cores 132'' and windings 132' of the individual cores 132 extend axially parallel to the rotation axis of the electric motor and gear system.

[0576] FIG. 11a shows an embodiment similar to that shown in FIG. 10a, except that an axial-type electric motor 130′ includes two sets of circularly arranged coils 132, each positioned relative to a magnetizable core structure 132s that magnetically couples to a core 132″. A rotatable structure 135, including a magnet 133 and two sets of coils 132a, 132b, is coaxially positioned such that both the first and second sets of coils 132a, 132b overlap the magnets of the rotatable structure 135, such that the first set of coils 132a propels the magnet 133 on its first side and the second set of coils 132b propels the magnet 133 on its second side. In an alternative embodiment, the rotatable structure / disk 135 between the sets of coils 132a, 132b could include two sets of magnets, one on each side, with the first and second sets of magnets being radially offset, thereby providing less lag in the electric motor. The battery 190 and / or control unit 195 are connected with leads 192 that connect the battery 190 and control unit 195 to the first and second sets of coils to sequentially energize the coils and thereby operate the axial-type electric motor 130'.

[0577] 12 shows an embodiment of the operating device 110 in which the coils 132 are positioned inside an enclosure 111 made of a cast material, which surrounds a sealed space containing the coils 132 as well as a battery 190 and a control unit 195. The coils 132 are connected to the battery 190 and the control unit 195 by leads 192, which in turn allow the coils 132 to be energized to propel the magnets 133. The magnets 133 are integrated into an operable element 143'''' which is fixed to a guide shaft 450 adapted to be guided by a guide recess 451. The coils 132 are distributed circularly around the rotation axis of the operating device 110, such that the cores 132'' of the individual coils 132 and the helices of the windings 132' extend axially parallel to the rotation axis of the operating device 110.

[0578] The manipulable element 143'''' is adapted to be propelled by a magnetic coupling between the coil 132 and the magnet 133 within the enclosure 111. The manipulable element 143'''' engages a hollow cylindrical first gear 144 including a first number of teeth 144t, e.g., 160, on its outer circumference, and a hollow cylindrical second gear 145 including a greater number of teeth 145t, e.g., 162, on its inner surface than the first gear 144. The outside of the first gear 144 presses against the inside of the second gear 145, causing the teeth 144t of the first gear 144 to interengage with the teeth 145t of the second gear 145 at position P1 separated by a position (e.g., position P2) where the teeth 144t, 144t, are not interengaged. Manipulation of the manipulable element 143′ advances the position P1, thereby generating relative rotation between the first gear 144 and the second gear 145. The gear system of the manipulation device of FIG. 12 further includes a third gear 146 having an inside with the same number of teeth as the outside of the first gear 144. Teeth 146t of the third gear 146 are adapted to interengage with teeth 144t of the first gear 144 such that the third gear 146 rotates relative to the second gear 145 along the interengagement position P1. The third gear 146 is connected to a force output 149 of the gear system 140 using a radially extending connecting structure 147 for transmitting force from the third gear 146 to the force output 149.

[0579] The implantable manipulation device 110 described with reference to FIG. 12 allows all electrical components, particularly the coil 132, battery 190, and control unit 195, to be completely sealed from the surrounding environment, i.e., both from body fluids during implantation and from additional components of the manipulation device. Furthermore, the implantable manipulation device 110 has few moving parts, and the magnet 133 can be completely surrounded by the manipulable element 143'''', which protects the magnet 133 from corrosion and wear. The surface of the enclosure 111 that engages the manipulable element 143'''' is preferably made from a wear-resistant material, such as a ceramic material, with the manipulable element 143'''' surrounding the magnet 133 preferably being made from a wear-resistant material, such as a ceramic material. The material of the enclosure disposed between the coil 132 and the magnet 133 is preferably made from a non-metallic and / or non-magnetic material, thereby minimizing the effect of magnetic coupling between the coil 132 and the magnet 133.

[0580] FIG. 13a shows a schematic diagram of how two gear systems 140a, 140b are positioned in series to function as a single gear system with a transmission equal to the transmission of the first gear system 140a multiplied by the transmission of the second gear system 140b. The gear systems 140a, 140b may be of the same type, such as the types of gear systems disclosed with respect to FIGS. 2a-5. Alternatively, one of the gear systems 140a, 140b may be of the type described with respect to FIGS. 2a-5, while the other gear system 140a, 140b may be of a different type, such as a planetary gear system or a standard gear system. The first and second gear systems 140a, 140b may have the same transmission or different transmissions.

[0581] In the embodiment of Figure 13a, the first and second gear systems are coaxially positioned (e.g., as further described with respect to Figure 8) such that the first gear system 140a can transmit forces axially to the second gear system 140b. The forces transmitted between the first and second gear systems are preferably rotational forces that can be transmitted centrally in both gear systems, circumferentially in both gear systems, or from the center of the first gear system 140a to the circumferentially of the second gear system 140b.

[0582] Figure 13b schematically illustrates an alternative embodiment of a gear system in which first and second gear systems 140a, 140b are connected in series. In the alternative embodiment shown in Figure 13b, the first gear system 140a is positioned "inside" the second gear system 140b (as further described, e.g., with respect to Figure 16). In the illustrated alternative, both the first and second gear systems 140a, 140b are gear systems of the type described with respect to Figures 2a-5, and a first gear of the first gear system is connected to an operable element of the second gear system, such that movement of the first gear of the first gear system relative to the second gear of the first gear system propels an operable element of the second gear system 140b. The first gear system may have an operable element as described in any one of the embodiments herein, and in embodiments in which the operable element includes planetary gears, the total transmission may be the transmission of the planetary gears times the transmission of the first gear system 140a times the transmission of the second gear system 140b.

[0583] Figure 14a shows yet another alternative in which three gear sets are coaxially stacked and connected in series to further enhance the transmission. The total transmission is the transmission of the first gear set times the transmission of the second gear set times the transmission of the third gear set. Similarly, Figure 14b shows a system in which first gear set 140a, second gear set 140b, and third gear set 140c are positioned radially inside one another and coupled in series in the same manner as the first and second gear sets are connected, for example, in Figures 13b and 16.

[0584] FIG. 15 shows an embodiment of a steerable implant manipulation device 110 similar to the embodiment described with respect to FIG. 4, except that the embodiment shown in FIG. 15 includes first and second gear systems 140a, 140b that are coaxially positioned along the rotational axis of the first and second gear systems 140a, 140b and connected in series. Both the first and second gear systems 140a, 140b include force inputs 142a, 142b that propel manipulable elements 143''a, 143''b, which are part of a planetary gear system. The manipulable elements 143'''a, 143'''b engage a first gear 144 that is also hollow and cylindrical and includes a first number of teeth on its outer circumference. The first gear 144 has a deflectable wall adapted to be engaged and deflected by two operable elements 143'''a, 143'''b, whereby the outside of the first gear 144 is pressed against the inside of the second gear 145, whereby the teeth of the first gear 144 interengage with the teeth of the second gear 145 in two positions separated by a position where the teeth are not interengaged. Because the second gear 145 has a greater number of gears on its inner surface than the first gear 144, operation of the operable elements 143'''a, 143'''b causes relative rotation between the first gear 144 and the second gear 145 by advancing the interengaged position.

[0585] The first and second gear systems 140a, 140b further include a hollow cylindrical third gear 146. The inner side 146a of the third gear 146 includes the same number of teeth as the outer side of the first gear 144, and the teeth of the third gear 146 are adapted to interengage with the teeth of the first gear 144, thereby causing the third gear 146 to rotate along at least one interengaged position relative to the second gear 145. The third gear 146 of the first gear system 140a is connected to a radially extending structure connecting the circumferentially arranged third gear 146 and a centrally arranged force output 149a of the first gear system / force input 142b of the second gear system 140b. The first and second gear sets 140a, 140b are thus connected in series by the third gear 146 of the first gear set 140a being connected to the force input 142b of the second gear set 140b.

[0586] In the embodiment shown in FIG. 15, the force output 149b of the second gear system 140b includes a hollow shaft connected to a threaded member 441 that also operates the reservoir 16. Details of the operation of the threaded member 441 are further described with respect to FIG. 4. Although the first and second gear systems 140a, 140b are described with respect to a hydraulic embodiment having a donus-shaped reservoir 160 that changes volume to push hydraulic fluid to a hydraulically operable body-engaging portion, the first and second gear systems 140a, 140b connected in series may be used in any of the other embodiments described herein. An example of an alternative embodiment includes: the threaded member 441 directly connecting to a body-engaging portion that could be directly connected to a patient's body, and the first and second gear systems 140a, 140b connected to a pump for pumping hydraulic fluid. The pump could be, for example, a peristaltic pump or a diaphragm pump.

[0587] The first gear system and the second gear system 140a, 140b may be enclosed in the same sealed space, thereby allowing force transmission between the first gear system and the second gear system 140a, 140b without the need to transmit force through a seal. In the embodiment shown in Figure 8, the force input 142a of the first gear system 140a penetrates the enclosure, but in alternative embodiments, an operating device such as an electric motor may be rigidly mounted in the gear system enclosure or enclosed along the first and / or second gear systems 140a, 140b, thereby eliminating the need for a through seal between the first and second gear systems 140a, 140b.

[0588] FIG. 16 shows a manipulation device 110 including an alternative embodiment of a gear system 140 similar to the embodiment shown in FIG. 15 . FIG. 16 shows the left half of the manipulation device 110 in cross section. The manipulation device includes a housing 111, which is a rigid part made, for example, from a hard polymer material, a ceramic material, or a metal. A portion of the housing 111 forms a coil enclosure 131, which surrounds the coil 132 and seals the coil 132 from body fluids and scar tissue when implanted. The coil 132 is one element of an electric motor and further includes a magnet 133 attached to a rotatable structure 135 having a radially extending portion 147 adapted to transmit force from the periphery of the manipulation device to the center of the manipulation device. The rotatable structure 135 is rotatably attached to the housing 110 using a first bearing Ba so that the rotatable structure can rotate relative to the housing 110. The central portion of the rotatable structure 135 constitutes a force input to the first gear system 140a, which is adapted to urge the manipulable element 143''' such that the manipulable element 143''' engages the first gear 114a of the first gear system 140a and causes the teeth of the first gear 144a to interengage with the teeth of the second and third gears 145a, 146a of the first gear system 140a. The second gear 145a of the first gear system 140a has more teeth than the first gear 144a of the first gear system 140a, causing the interface between the first gear 144a and the second gear 145a to rotate (as described further above). The third gear 146a has the same number of teeth as the first gear 144a and therefore rotates along the interface. The third gear 146a is connected to a radially extending portion 147 adapted to transmit force from the periphery to a central portion of the manipulation device and to a force input 140a for the second gear system 140b. The structure including the third gear, the radially extending structure 147, and the force input 142b of the second gear system 140b is rotatably connected to the force input 142a of the first gear system 140a using bearing Bb and to the force output 149c from the second gear system 140b using bearing Bc.The second gear system 140b operates in a similar manner to the first gear system 140a, and the structure including the third gear 146b of the second gear system 140b, the radially extending portion 147, and the force output portion of the second gear system 149c is rotatably connected to the housing 110 of the operating device 110 using a bearing Bd.

[0589] In the manipulation device shown in FIG. 16, sequential energization of the coils 132 propels the magnet 133 connected to the rotatable structure 135, which in turn propels the first gear system 140a. The first gear system 140a is connected in series with the second gear system 140b, which also provides a force output 149c that may be used to power the body-engaging portion of a manipulable implant with which the manipulation device 110 is used. With the first and second gear systems 140a, 140b connected in series, the total transmission of the manipulation device 110 is equal to the transmission of the first gear system 140a times the transmission of the second gear system 140b. Thus, the force output 149c outputs a force at the speed of the rotatable structure containing the magnet 133 times the transmission of the first gear system 140a times the transmission of the second gear system 140b.

[0590] Figure 17 shows an embodiment of a manipulation device 110 similar to the manipulation device described with respect to Figure 16, with the difference being that the manipulation device of Figure 17 has first and second force outputs 149a, 149b extending from within the enclosure 111 of the manipulation device 110, thereby enabling the manipulation device 110 to supply a first type and a second type of mechanical work, i.e., a first form of mechanical work having a first force and a first velocity, and a second form of mechanical work having a second force and a second velocity.

[0591] More specifically, the coil 132 enclosed by the coil enclosure 131 is, in turn, energized, which propels a magnet 133 affixed to a rotatable structure 135 connected to a force input 142a of the first gear system. The rotatable structure 135 is also connected to a force output 149a of the manipulation device 110 so that a high-speed force output is provided from the manipulation device 110. The high-speed force output 149a may be coupled, for example, to a generator for generating electrical current inside the patient's body. Because the first gear system is serially coupled to the second gear system, the first gear system propels the second gear system, which ultimately provides a force output using a third gear 146a of the second gear system, and thus a low-speed force output 149c using a connection via the radially extending rotatable structure 147. The low-speed force output 149c may be connected, for example, to a portion of the maneuverable implant that engages the patient's body and requires low-speed, high-force mechanical work.

[0592] FIG. 18 a shows an embodiment of a manipulation device in which a first gear system 140 a is positioned radially inward of a second gear system 140 b, such that the second gear system 140 b axially overlaps the first gear system 140 a (axially relative to the axis of rotation of the manipulation device 110). As in the manipulation devices described with respect to FIGS. 16 and 17 , the manipulation device includes an electric motor including a coil 132 including a coil winding 132 ′ and a coil core 132 ″, e.g., an iron core. The coil is adapted to be energized to produce a magnetic field adapted to influence and propel a magnet 133 affixed to a rotatable structure 135. In alternative embodiments, the magnet 133 could be replaced by any magnetic material that could be attracted by the magnetic field generated by the coil 132. The rotatable structure 135 similarly propels a force input 142 a of the first gear system 140 a, similarly engaging the inside of a first gear 144 a of the first gear system. The first gear 144a engages the manipulable elements 143'''a, 143'''b, which deflects the first gear 144a and operates the third gear 146a, similar to the gear system functionality described above. The third gear 146a of the first gear system 140a is connected to a radially extending structure 147 that constitutes the manipulable element 143:2 of the second gear system 140b. The manipulable element 143:2 of the second gear system 140b has teeth that interengage with the teeth of the third gear 146b of the second gear system 140b. The second gear 140a, 140b is connected to a radially engaging structure 147 that transmits force from the periphery of the manipulation device to the center of the manipulation device 110, propelling a force output 149c of the second gear system 140b. Having the electric motor and the first and second gear systems 140a, 140b in the same plane allows for a very thin design suitable for subcutaneous implantation.

[0593] The force output 149c of the second gear system 140b is connected to a threaded member 441 that converts the rotational force into a linear reciprocating force that operates the toroidal reservoir 160, as further described with respect to FIG.

[0594] The housing of the manipulation device 111 encloses the manipulable device so that bodily fluids do not affect the manipulation device 110. The housing / enclosure 111 may be made from a biocompatible metallic material, such as titanium or tantalum, to prevent migration of bodily fluids into the manipulation device 110. In alternative embodiments, the enclosure 111 may be made from a ceramic material, such as silicon carbide or zirconium carbide, or a polymeric material, such as UHWPE or PTFE, or glass. In any example, the enclosure should be made from a low-permeability material so that bodily fluids are prevented from passing through the walls of the enclosure 111.

[0595] In the embodiment shown in FIG. 18a, the coil 132 is further enclosed within a coil enclosure 131, which further seals the coil 132 from other components of the manipulation device 110 and / or bodily fluids.

[0596] The manipulation device of Fig. 18a further includes an enclosed space containing a battery 190 adapted to power the electric motor and a control unit 195 adapted to control the electric motor and additional maneuverable elements of the maneuverable implant. The battery 190 and / or control unit 195 are connected with leads 192 that connect the battery 190 and / or control unit 195 to a wireless energy receiver and / or a wireless communication unit and / or additional batteries for providing additional energy to the manipulation device. In embodiments in which the electric motor is powered directly from the wireless energy receiver, the battery 190 may be adapted to power only the control unit 195. The wireless energy receiver may, in other embodiments, be integrated into and enclosed in the same enclosure 111 that encloses the manipulation device 110.

[0597] 18b shows in an exploded view the first and second gear systems and the electric motor of the manipulation device 110 of FIG. 11a. The bottom section is a stationary portion of the manipulation device 110 including the second gear 145a of the first gear system and the second gear 145b of the second gear system 145b. The bottom section further includes the coil 132 of the electric motor, including a coil core 132″ and a coil winding 132″, and a coil enclosure 131 adapted to hermetically enclose the coil 132, such that the coil 132 is sealed from bodily fluids and / or from a lubricant adapted to lubricate the first and / or second gear systems and / or from hydraulic fluid for transmitting force from the manipulation device 110 to a hydraulically-operable body-engaging portion of the manipulable implant (further described in connection with other embodiments described herein). Above the stationary parts 132, 145a, 145b is depicted a rotatable structure 135. The rotatable structure 135 includes a magnet 133 adapted to be in magnetic communication with the coil 132, so that sequential energization of the coil 132 propels the magnet 133 and thus the rotatable structure 135 to which the magnet 133 is fixed. The rotatable structure 145 also includes an input 142a to a first gear system 140a, the input of which is adapted to propel, by interengaging teeth or by friction, a planetary gear mechanism 143''', which is the operable element 143:1 of the first gear system 140a. The manipulable element 143''' engages and deflects the first gear 144a of the first gear system 140a such that the outer teeth 144t of the first gear 144a interengage the inner teeth 145t of the second gear 145a of the first gear system, which is part of the stationary portion. Because the first gear 144a of the first gear system includes fewer teeth 144t than the second gear 145b of the second gear system, the interengagement position between the first and second gears 144a, 145a is advanced, and because the third gear 146a of the first gear system includes the same amount of teeth 146t as the first gear 144a, the third gear 146a moves with it to the advanced position.The third gear 146a of the first gear system is an integral part of the operable element 143:2 of the second gear system and therefore also includes an output 149b of the second gear system and a radially extending structure 147 connecting the third gear 146a of the first gear system with the rotating operable element 143:2' of the operable element 143:2.

[0598] The rotating operable element 143:2' of the operable element 143:2 of the second gear system engages and deflects the first gear 144b of the second gear system, so that the second gear system, similar to the first gear system, drives the third gear 146b of the second gear system. The third gear 146b of the second gear system is integrated within a structure (the depicted top structure) that further includes a radially extending element 147 connecting the third gear 146b to an output 149b of the second gear system (and of the operating device), so that the mechanical work generated by the electric motors 132, 133 can be output as rotational force via the output 149b.

[0599] In the embodiment shown in Figure 18b, the first and second gear systems have the same transmission. However, it is conceivable that the second gear system has a larger transmission than the first gear system, i.e., the difference in the number of teeth between the first and second gears 144a, 144b, 145a, 145b of the first and second gear systems is the same, but the gears of the second gear system have more teeth than the gears of the first gear system. For example, a first gear 144a of the first gear system with 98 teeth, a second gear 145 of the first gear system with 100 teeth, a first gear 144b of the second gear system with 198 teeth, and a second gear 144b of the second gear system with 200 teeth would result in a first gear system with a 1:50 transmission (plus the planetary gear system transmission provided by the operable element) and a second gear system with a 1:100 transmission. In some applications, the gears in the second gear system are required to transmit large forces at low speeds, so it is advantageous for the gears in the second gear system to have the same number of teeth (and therefore larger) as the gears in the first gear system.

[0600] FIG. 19 illustrates an alternative embodiment of the manipulation device similar to that described with reference to FIG. 18 , with the difference being that the first gear system 140a is a peripherally disposed gear system and the second gear system 140b is a centrally disposed gear system. In the embodiment shown in FIG. 19 , the coil 132 is disposed inside a rotatable structure 135 that includes a magnet 133. In the embodiment shown in FIG. 19 , the rotatable structure 135 is integral with the manipulable element 143:1 of the first gear system 140a. In the embodiment shown in FIG. 19 , the manipulable element 143:1 comprises a rotationally manipulable element 143:1′ adapted to engage the inside of the first gear 144a to deflect the first gear 144a. The interengagement of the first gear 144a and the third gear 146a of the first gear system 140a propels the third gear 146a of the first gear system 140a, which is connected to a power input 142b adapted to propel the manipulable element 143''', and the manipulable element 143''' deflects the first gear 144b of the second gear system 140b to propel the third gear 146b of the second gear system 140b, which serves as a power output of the manipulation device 110. The structure 131, 145b surrounding the coil 132 constitutes the stationary part of the manipulation device 110 and is directly or indirectly connected to the second gear 145a of the first gear system 140a, such that the second gear 145a of the first gear system 140a is fixed together with the second gear 145b of the second gear system 140b and the coil enclosure 131.

[0601] Figure 20 is a cross-sectional view of the manipulation device of Figure 19. The structure 131, 145b surrounding the coil 132 constitutes the stationary part of the manipulation device 110 and is connected to the second gear 145a of the first gear system 140a, so that the second gear 145a of the first gear system 140a is fixed together with the second gear 145b of the second gear system 140b and the coil enclosure 131. In the embodiment of Figures 12 and 13, the entire lower part 111' of the enclosure 111 rotates to transmit forces from the periphery of the manipulation device 110 to the center of the manipulation device 110, and thus from the first gear system 140a to the second gear system 140b. The operating device 110 is further surrounded by an additional enclosure (preferably connected to the stationary parts 131, 145b, 145a of the operating device), thereby eliminating the need for a direct connection of the rotatable lower part of the enclosure 111' to the patient's body.

[0602] In the embodiment shown in FIG. 20, the power input portion 142b of the second gear system 140b (contained in the same structure as the power output portion 149b of the first gear system) is rotatably fixed by a recess r in a structure that includes the power output portion 149b of the second gear system 140b, the third gear 146b of the second gear system 140b, and a radially extending rotatable structure 147 that connects the third gear 146b of the second gear system 140b to the power output portion 149c of the second gear system 140b.

[0603] 21 illustrates an embodiment of an implantable manipulation device 110 including a magnetic coupler 460 connected to the power input 142 of the manipulation device 110. The magnetic coupler 460 includes a first set of magnets 461 a, 461 b connected to an outer rotatable structure 463, which includes a radially extending portion 147 connecting the rotating structure to a power output 149 a of an electric motor (not shown). Operation of the electric motor rotates the power output 149 a, which propels the rotatable structure 463 including the magnets 461 a, 461 b. The outer magnets 461 a, 461 b are magnetically coupled to inner magnets 462 a, 462 b connected to an inner rotatable structure 464, which is connected to the power input 142 of the gear system 140. The outer rotatable structure 463 is positioned radially outward of the inner rotatable structure 464. Gear system 140 is the gear system described with respect to FIG. 3b or FIG. 4. In the embodiment shown in FIG. 21, power output 149b of gear system 140 actuates operable reservoir 160 to move hydraulic fluid from reservoir 160 to the hydraulically operable body-engaging portion connected to reservoir 160 by fluid conduit 162. Operation of operable reservoir 160 is described in more detail with respect to FIG. 4. In the alternative, power output 149b may be connected to a hydraulic pump (e.g., a valveless pump, a valve pump, a peristaltic pump, a diaphragm pump, a gear pump, or a bellows pump) for transport of hydraulic fluid to the hydraulically operable body-engaging portion. Furthermore, power output 149b of gear system 140 may be connected to some other means, e.g., a mechanical means, for operating the body-engaging portion.

[0604] The inner rotatable structure 464 is surrounded by an enclosure 111m such that the gear system 140 and the inner rotatable structure 464 are hermetically enclosed and therefore sealed from body fluids during implantation. The enclosure 111m is preferably made of a non-metallic, non-magnetic material such as a polymeric material (e.g., UHMWPE, PEEK, or PUR). However, the enclosure 111m may also be made of any of a carbon material, a boron material, a mixture of materials, an alloy of materials, a metallic material, titanium, aluminum, a ceramic material, a polymeric material, silicone, and Parylene® coated silicone.

[0605] The inner and / or outer magnets 461a, 461b, 462a, 462b may be, for example, neodymium magnets, although one of the inner set of magnets 461a, 461b and the outer set of magnets 462a, 462b may be a magnet, and only one of the inner set of magnets 461a, 461b and the outer set of magnets 462a, 462b may be made of a material suitable for being attracted by magnetic force (e.g., iron).

[0606] The electric motor (not shown) connected to the outer rotatable structure 463 can be, for example, an alternating current (AC) electric motor, a direct current electric motor, a linear electric motor, an axial electric motor, a piezoelectric motor, a three-phase motor, a two or more phase motor, a bimetallic motor, and a shape memory metal motor.

[0607] FIG. 22 illustrates an embodiment of an implantable manipulation device 110 including a magnetic coupler 470 connected to the power output 149b of the manipulation device 110, or more specifically, to the power output 149b of the second gear system 140b of the manipulation device 110. The manipulation device 110 providing the force to the power output 149b is the manipulation device 110 including the electric motor 130 and the first and second gear systems 140a, 140b, and is described in detail with respect to FIG. 18a. However, the magnetic coupler 470 may be added to any of the manipulation devices disclosed herein, such as the manipulation devices described with respect to FIGS. 6, 7, 8, 9, 10, 11, 12, 16, 17, and 19. Operation of the manipulation device 110 rotates the power output 149b, which propels the rotatable structure 464 including the magnets 471a, 471b. The inner magnets 471 a, 471 b are magnetically coupled to outer magnets 472 a, 472 b connected to an outer rotatable structure 463 that is connected to the power output unit 149 c. The outer rotatable structure 463 is disposed radially outward of the inner rotatable structure 464.

[0608] The power output 149c is directly or indirectly connected to the operable body-engaging portion such that the operating device 110 can operate the operable body-engaging portion via a magnetic coupler 470. The inner rotatable structure 464 is surrounded by an enclosure 111m such that the operating device 110, i.e., the electric motor 130 and the first and second gear systems 140a, 140b, are hermetically enclosed and sealed from bodily fluids during implantation. The enclosure 111m is preferably made of a non-metallic, non-magnetic material such as a polymeric material (e.g., UHMWPE, PEEK, or PUR). However, the enclosure 111m may also be made of any of a carbon material, a boron material, a mixture of materials, an alloy of materials, a metallic material, titanium, aluminum, a ceramic material, a polymeric material, silicone, and Parylene®-coated silicone.

[0609] In the operating device 110 of Figure 22, a sealed space is further provided within the operating device enclosure 111, which comprises a battery 190 adapted to power the electric motor 130 and a control unit 195 adapted to control the electric motor 130 and / or additional operable elements of the operable implant.

[0610] The battery 190 and / or control unit 195 are connected to leads 192 which connect the battery 190 and / or control unit 195 to an additional battery 190 for supplying additional energy to the wireless energy receptor and / or the wireless communication unit and / or the operating device. The electric motor 130 is an alternating current (AC) electric motor 130 and the control unit 195 comprises a frequency converter for changing the frequency of the alternating current to control the AC electric motor. In the alternative where the electric motor 130 is powered directly from the wireless energy receptor, the battery 190 is adapted simply to power the control unit 195.

[0611] FIG. 23 illustrates an embodiment of an implantable peristaltic pump 150′ adapted to pump and deliver hydraulic fluid to a manipulable, body-engaging portion of a manipulable implant using hydraulic pressure. The peristaltic pump 150′ is adapted to be connected to a power output of a manipulation device (e.g., any of the manipulation devices (110) disclosed herein). The implantable peristaltic pump 150′ includes a deflectable, tubular, fluid-transporting hollow member 152 made of a resilient material (e.g., an elastomeric polymer material such as silicone, Parylene®-coated silicone, NBR, Hypalon, Viton, PVC, EPDM, polyurethane, or natural rubber). The deflectable hollow member 152 is adapted to deliver hydraulic fluid by being deflected by manipulable compression members 153a-c or wipers adapted to engage and compress the hollow member 152. The compression members 153a-c are driven by the manipulation device. Hollow member 152 is positioned within peristaltic pump housing 151 such that hollow member 152 is compressed between actuatable compression members 153a-c. Peristaltic pump 150' completely separates hydraulic fluid from body-derived fluids, resulting in leak-free hydraulic fluid transport from a fluid reservoir (e.g., fluid reservoir 160 shown in other embodiments herein) to the hydraulically actuatable body-engaging portion.

[0612] 24a and 24b illustrate an implantable manipulation device 110 including a peristaltic hydraulic pump 150' similar to the peristaltic pump 150' described with respect to FIG. 23, except that the manipulable compression members include rollers 153a'-153c' rotatably connected to a rotatable structure 155 that is propelled by a power output 149 of a gear system 140. The gear system 140 is connected to an electric motor 130 adapted to propel the gear system 140. The electric motor 130 is, in the embodiment shown in FIG. 24, powered by a battery 190 enclosed within an enclosure 111 that surrounds the manipulation device 110.

[0613] Rollers 153a'-153b' sequentially compress hollow member 152 to transport the fluid within hollow member 152. FIG. 24b shows a cross section of an operating device including peristaltic pump 150', showing hollow member 152 in an uncompressed state 152 and a compressed state 152' when roller 153c' compresses hollow member 152' against housing 151 of peristaltic pump 150'. Electric motor 130 and gear system 140 may be, for example, electric motor (130) and gear system (140) shown in any of the embodiments herein. When rollers 153a'-153c' rotate in contact with hollow member 152, they do not wear or rupture hollow member 152 as wiping or sliding operable compression members would, thereby extending the life of hollow member 152.

[0614] 25a and 25b illustrate an embodiment of an actuation device 110 including a peristaltic hydraulic pump, such as the peristaltic pump described in more detail with respect to FIG. 23. The peristaltic pump includes a hollow member 152 for fluid transport and operable compression members 153a, 153b, and 153c adapted to engage and compress the hollow member 152. In the actuation device shown in FIGS. 25a and 25b, the compression members 153a-153c are connected to a power output 149 of a gear system connected to an electric motor, both of which are disposed within the peristaltic pump. The electric motor and gear system are similar to those described with respect to FIG. 7, except that the power output 149 of the gear system in FIGS. 25a and 25b is connected to the operable compression member 153a, which propels the operable compression member 153a, thereby actuating the peristaltic pump via the gear system.

[0615] More specifically, the coil 132 of the electric motor is connected by electrical leads (not shown) to a control unit 195, which is connected to a battery 190. The control unit generates, via a converter, an alternating current (AC) that is used to energize the coil. The resulting alternating current in turn energizes the coil 132, creating a propagating magnetic field within the coil 132 that propels a magnet 133 fixed to the rotatable structure 135. The rotatable structure 135 is connected to a power input 142 of a gear system, which in turn deflects a first gear 144 of the gear system, causing relative rotation between a third gear 146 and a second gear 145, thereby propelling operable elements 143'''a, 143'''b, which propels a power output 149 of the gear system that is directly connected to operable compression members 153a, 153b, 153c.

[0616] Thus, hollow member 152 forms three-quarters of a loop surrounding the electric motor and gear system, and compression members 153a-153c compress hollow member 152 toward the outer periphery of the loop, pressing against housing 151, which is part of the enclosure 111 of the operable device.

[0617] The hollow member 152 is sealed to the manipulation device enclosure 111 using a sealing member 157 (e.g., adhesive), thereby sealingly enclosing the entire manipulation device and sealing it from bodily fluids, while simultaneously sealingly enclosing the hydraulic system within the hollow member so that hydraulic fluid cannot leak into the patient's body and / or the manipulation device. Furthermore, in the embodiment of Figures 25a and 25b, the peristaltic pump is located in the same plane as the electric motor and gear system, allowing the entire manipulation device to be very thin and suitable for subcutaneous implantation.

[0618] FIG. 26 illustrates an embodiment of an actuation device comprising a hydraulic pump with a toroidal reservoir 160 adapted to contain hydraulic fluid. The toroidal reservoir 160 is adapted to be compressed by a radially extending engagement member 444, which is actuated by a portion of the actuation device 110′ comprising an electric motor and gear system (e.g., any of the electric motor and gear system combinations described herein). The embodiment of the actuation device illustrated in FIG. 26 is very similar to the embodiment described with respect to, for example, FIG. 4 . The primary difference is that the embodiment illustrated in FIG. 26 further comprises an additional enclosure 161 surrounding the toroidal reservoir 160 and the radially extending engagement member 444. The additional enclosure 161 comprises a sealing member 167 adapted to seal between the additional enclosure and a fluid conduit adapted to transport hydraulic fluid from the toroidal reservoir 160 to the hydraulically operable body engagement portion for operating the hydraulically operable body engagement portion. The additional enclosure further seals the manipulation device 110 from body-derived fluids, reducing the risk of fibrous tissue ingrowth affecting the manipulation of the manipulation device 110 .

[0619] Figure 27a shows an embodiment of an operating device 110 comprising an operable reservoir 160 adapted to contain hydraulic fluid. The electric motor and double gear system parts of the operating device are similar to those of the operating device described with reference to Figures 18b and 19. However, the operating device of Figures 27a and 27b further comprises a circular reservoir 160 surrounding the operating device. The circular reservoir 160 comprises a movable wall portion adapted to compress and expand the circular reservoir 160, thereby varying the volume of the reservoir 160. The third gear 146b of the second gear system, which rotates together with the interengaging portions of the first gear 144b and the second gear 145b (described in more detail with respect to Figures 27a and 27b), is connected to an operating spiral adapted to engage with a corresponding radially fixed operating spiral 473, whereby operation of the operating spiral 472 relative to the radially fixed operating spiral 473 causes the radially fixed operating spiral to move axially, resulting in compression of the reservoir 160.

[0620] FIG. 27a shows the operating device 110 with the operating spiral 473 aligned with a corresponding radially fixed operating spiral, with the two spirals mating to form the thinnest possible structure, thereby minimizing compression of the reservoir 160, i.e., with the thinnest portion 472b of the operating spiral engaged with the thickest portion ...

Claims

[Claim 1] 1. A steerable implant adapted to be implanted in a patient's body, comprising: the steerable implant comprises a steering device and a body engaging portion; the operating device comprises an electric motor having a stationary part comprising a plurality of coils and a movable part comprising a plurality of magnets, whereby sequential energization of the coils causes the magnets to be propelled by magnetic force, thereby propelling the movable part; the steerable implant further comprises a gear system adapted to receive mechanical work having a first force and velocity as an input from the moving part of the electric motor and to output mechanical work having a different force and velocity; The gear system comprises: - an operable element connected to said moving part and configured to be propelled by said moving part; a first gear having a hollow cylindrical shape and including a first number of teeth on its outer circumference; and a second gear having a hollow cylindrical shape and having more teeth on its inner surface than said first gear; Equipped with the manipulable element is adapted to bias the first gear and maintain the first gear biased such that the teeth of the first gear interengage with the teeth of the second gear at at least two angularly spaced positions separated by a position where the teeth do not interengage; A manipulable implant, wherein manipulation of the manipulable element advances the at least two angularly spaced locations, thereby generating relative rotation between the first gear and the second gear.

Images