Medical grade actuator comprising modular structure and medical device comprising same
阅读说明:本技术 含模块化结构的医疗级致动器和包括该致动器的医疗设备 (Medical grade actuator comprising modular structure and medical device comprising same ) 是由 克里斯多夫·奥贝特 费比安·卡奇 于 2017-11-30 设计创作,主要内容包括:用于医疗设备(100)的致动器(1),致动器包括电动机、机械传动装置和磁性耦合装置,磁性耦合装置被布置成当所述电动机由能量源供电时将机械转矩从电动机传输到机械传动装置,其中,所述电动机和磁性耦合装置的运动学地连结到电动机的第一部件被布置并气密密封在第一套管模块中,并且其中,所述机械传动装置和耦合装置的运动学地连结到所述机械传动装置的第二部件被布置在第二套管模块中,所述第一套管模块和所述第二套管模块各自包括互补的紧固装置,使得所述第一套管模块和所述第二套管模块能够以如下方式彼此可拆卸地连接:磁性耦合装置的所述第一部件和所述第二部件在所述第一套管模块与所述第二套管模块连接时磁性地耦合在一起。(Actuator (1) for a medical device (100), the actuator comprising an electric motor, a mechanical transmission and a magnetic coupling arranged to transmit a mechanical torque from the electric motor to the mechanical transmission when said electric motor is powered by an energy source, wherein a first part of said electric motor and magnetic coupling kinematically linked to the electric motor is arranged and hermetically sealed in a first cannula module, and wherein a second part of said mechanical transmission and coupling kinematically linked to said mechanical transmission is arranged in a second cannula module, said first and second cannula modules each comprising complementary fastening means such that said first and second cannula modules are detachably connectable to each other in the following manner: the first and second parts of the magnetic coupling device are magnetically coupled together when the first ferrule module is connected with the second ferrule module.)
1. Actuator (1) for a medical device (100), comprising an electric motor (6), a mechanical transmission (8) and a magnetic coupling (9) arranged to transmit a mechanical torque from the electric motor to the mechanical transmission when the electric motor is powered by an energy source, wherein a first part (9a) of the electric motor (6) and the magnetic coupling kinematically linked to the electric motor is arranged and hermetically sealed in a first cannula module (2), and wherein a second part (9b) of the mechanical transmission (8) and the coupling kinematically linked to the mechanical transmission (8) is arranged in a second cannula module (3), the first and second cannula modules (2, 3) each comprising complementary fastening means (4), 5) such that the first and second casing modules (2, 3) can be detachably connected to each other in the following manner: the first and second parts (9a, 9b) of the magnetic coupling device are magnetically coupled together when the first and second ferrule modules are connected.
2. Actuator according to claim 1, wherein the magnetic coupling means comprise first and second magnets (9a, 9b) arranged as first and second parts of the magnetic coupling means in the first and second bushing modules (2, 3), respectively, the first and second magnets being coupled to the electric motor (6) and the mechanical transmission means (8), respectively, for transmitting a mechanical torque from the electric motor to the mechanical transmission means.
3. Actuator according to claim 1 or 2, wherein a gear head (7) is connected to the electric motor (6), said gear head holding the first part (9a) of the coupling means.
4. Actuator according to any of claims 1 to 3, wherein the mechanical transmission means (8) comprises a lead screw (81) cooperating with a nut (82) mounted on the lead screw, the lead screw (81) or the nut (82) being connected on the one hand to the second part (9b) of the magnetic coupling means and on the second hand to a drive element (121, 82) for transmitting a driving force to the actuated device (10).
5. The actuator of claim 1, further comprising an energy source in the first cannula module to power the motor.
6. The actuator of claim 5, wherein the energy source comprises a power battery.
7. An actuator according to any of claims 1 to 6, further comprising an electronic control unit electrically connected to the energy source and the electric motor, the control unit comprising a microprocessor and a memory, a computer program being stored on the memory for operating the electric motor.
8. The actuator of claim 7, wherein the control unit includes a wireless transmission that allows for wireless setup and diagnostics for the control unit and the motor.
9. The actuator according to any of claims 1 to 8, wherein the complementary fastening means (4, 5) of the first and second ferrule modules (2, 3) are arranged to comprise any of the following means: a sliding device, a magnetic device, a buckle matching device, a screw fixing device and a convex-concave containing device.
10. Medical device (100) comprising an actuator (1) according to any of claims 1 to 9 and an artificial collapsible device (10) comprising a collapsible element (11) and a flexible transmission (12) connectable to the mechanical transmission (8) in the second cannula module (3) of the actuator (1).
11. Medical device (100) according to claim 10, wherein the contractile element (10) is adapted to contract a hollow human organ, the contractile element being in a rest position or in an activated position, the activated position being defined by the contractile element contracting the organ, the rest position being defined by the contractile element not contracting the organ, the actuator (1) being configured to exert a tensile strength on the flexible transmission (12) to drive the contractile element (10) from its rest position to its activated position, and to release the tensile strength, thereby enabling the contractile element to return to its rest position.
Technical Field
The present invention relates to the field of medical devices. More specifically, the invention relates to a medical grade electromechanical actuator having a modular structure, wherein the actuator comprises a first module substantially sealingly enclosing electronic elements of the actuator and a second module substantially enclosing mechanical elements of the actuator, the first and second modules being magnetically connectable to each other.
The invention further relates to a medical device comprising such an actuator, in particular for actuating an artificial contractile structure, such as an artificial sphincter, in particular but not exclusively for the treatment of urinary incontinence.
Background
Various forms of artificial collapsible structures and associated medical devices have been proposed in the prior art for the treatment of urinary incontinence. These existing structures and devices can be broadly divided into two major categories. The first type is a hydraulic/fluid constriction system which relies on the circulation of fluid into a fluid circuit arranged in the artificial sphincter device by a pump as actuation means. Well-known examples of such Systems are the AUS 800 sold by american medical Systems (american medical Systems) corporation; more recently, however, many other examples have also been disclosed, for example in US2016346071 or US 2016135938. The second type is a cable/lead retraction system that relies on a tension element, such as a cable, or the like, which is pulled and released by a mechanical actuator to retract and release pressure against a hollow body organ, such as the urethra of a patient. The applicant has for a long time actively proposed a second type of solution, such as in WO2012000680, WO2013093074 or WO 2015117664. In the case of the second type, it is almost necessary to rely on electromechanical actuators to apply tensile strength to the cable operating the collapsible structure.
Since such actuators are implanted in a patient, it is crucial to ensure an airtight seal of the constituent elements of the actuator, in particular of the electrical and electronic components of the actuator (in particular direct water intake), for obvious safety reasons. It is also important to prevent corrosion of any metal parts of the actuator as much as possible. However, such an airtight condition of the actuator proves difficult, since the entry of body fluids into the actuator is almost inevitable at the mechanical connection interface between the cable-tensioning element of the artificial sphincter and the actuator. Over time, this may lead to a malfunction of the actuator, requiring urgent replacement to prevent any risk of patient infection due to corrosion or leakage of the batteries in the actuator.
It is therefore an object of the present invention to propose an improved actuator for a medical device, in particular for a medical device comprising an artificial contractile structure for preventing urinary incontinence.
Disclosure of Invention
According to a first object, the present invention relates to an actuator for a medical device, in particular for a medical device comprising an artificial contractile structure as defined in
The actuator of the invention comprises an electromechanical actuating device comprising an electric motor, a transmission and a magnetic coupling arranged to transmit a mechanical torque from the electric motor to the transmission when said electric motor is powered by an energy source.
According to the invention, the first part of the electric motor and the coupling means which is kinematically linked to the electric motor is arranged and hermetically sealed in a first bushing module, while the second part of the transmission means and the coupling means which is kinematically connected to the transmission means is arranged in a second bushing module, the first and second bushing modules each comprising complementary fastening means, such that the first and second bushing modules can be detachably connected to each other in the following manner: the first and second parts of the magnetic coupling device are magnetically coupled together when the first ferrule module is connected with the second ferrule module.
The actuator of the invention thus comprises a modular structure, whereby moisture sensitive components of the actuator, such as electrical and electronic components, are safely sealed in a first airtight bushing module, whereas non-moisture sensitive components, such as purely mechanical elements, are arranged in a second bushing module, which can be connected with the first bushing module, so that the second bushing module and the first bushing module are mechanically coupled by complementary parts of the magnetic coupling means, which are located in the first bushing module and the second bushing module, respectively.
This provides the following advantages: the first or second cannula module is made a "disposable" part of the actuator that can be removed and replaced as necessary in the event of dysfunction or otherwise. For example, the mechanical transmission in the second bushing module may have a much longer service life than the electronics and batteries housed in the first bushing component. The replacement of only the first cannula module and contents may be performed by simply replacing the subcutaneously implanted first cannula module of the actuator. This can even be done in an "outpatient" environment.
Also, if desired, the second cannula module and/or any devices connected to the second cannula module can be easily replaced, such as by laparoscopic surgery, while the first cannula module can remain implanted for a longer period of time due to its air tight nature.
Preferably, the magnetic coupling means comprises a first magnet and a second magnet, the first magnet and the second magnet being arranged as a first part and a second part of the magnetic coupling means in a first cannula module and a second cannula module, respectively, the first magnet and the second magnet being coupled to the electric motor and the transmission, respectively, for transmitting the mechanical torque from the electric motor to the transmission.
Preferably, a gear head is connected to said electric motor, said gear head holding said first part of the coupling device.
Preferably, the transmission means comprises a lead screw which cooperates with a nut mounted on said lead screw, said lead screw or said nut being connected on the one hand to said second part of the magnetic coupling means and on the second hand to a drive element for transmitting a driving force to the actuated device via the connector.
Preferably, the actuator comprises an energy source located in the first cannula module to power the motor. Still preferably, the energy source comprises an electric battery.
Preferably, the actuator comprises an electronic control unit electrically connected to said energy source and said electric motor, said control unit comprising a microprocessor and a memory, a computer program being stored on the memory for operating the electric motor.
Preferably, the control unit comprises a wireless transmission allowing wireless settings and diagnostics for the control unit and the electric motor.
Preferably, the complementary fastening means of the first and second casing modules comprise any one of the following: a sliding device, a magnetic device, a buckle matching device, a screw fixing device and a convex-concave containing device. Preferably, the magnetic coupling means may be sufficient to ensure a proper connection between the first and second ferrule modules.
According to a second object, the invention also relates to a medical device comprising an actuator as described above and an artificial contractile device comprising a contractile element and a flexible cable transmission connected to a driving element of the transmission in the second cannula module.
Preferably, the retractable element is adapted to retract a hollow body organ, the retractable element being in a rest position or in an activated position, the activated position being defined by the retractable element retracting the organ, and the rest position being defined by the retractable element not retracting the organ, the actuator being configured to exert a tensile strength on the flexible transmission to drive the retractable element from its rest position to its activated position, and to release the tensile strength to return the retractable element to its rest position.
Drawings
Further features of the invention will be described below in conjunction with the appended drawings, which show:
FIG. 1: a schematic perspective view of a medical device according to the invention comprising an actuator according to the invention, the actuator comprising a first main cannula module and a second cannula module remote from the first module and connected to an artificial collapsible structure, such as for the treatment of urinary incontinence;
-figure 2: a view similar to fig. 1, except for a partial cross-section of the first cannula module taken along the longitudinal plane P shown in fig. 1;
-figure 3: a schematic close-up perspective view of the actuator of fig. 2;
-figure 4: schematic cross-sectional views of screw-type actuators known from the prior art, wherein the hatched lines represent the first and second bushing modules of the actuator of the invention;
-figure 5: an alternative embodiment of a medical device according to the invention is shown, comprising a connector for connecting the second cannula module of the actuator of the invention and the manually retractable structure;
-figure 6: a schematic cross-sectional view of a connector for the manually collapsible structure of fig. 1-2, which connector is connected to a second sleeve module of the actuator of the invention to link the flexible transmission of the manually collapsible structure to the screw of the mechanical transmission arranged in said second sleeve module.
Detailed Description
Fig. 1 and 2 show a
The artificial
Fig. 1 and 2 show the shrinkable element 11 (otherwise referred to as a cuff) in its open position, i.e. its position before being applied around a hollow body organ. The
A plurality of transverse
At the distal end of the flexible strip 111 a closure 113 is provided. Thus, the closure 113 is arranged to enable the
When in place around a hollow body organ in the closed position of the collapsible element, the maximum circumference of the
As shown in fig. 1 to 4, a
The
The
According to the invention, the
The control unit preferably comprises a microprocessor and a memory, on which a computer program is stored for operating the electric motor. Preferably, the control unit comprises a wireless transmission allowing wireless settings and diagnostics for the control unit and the electric motor. Thus, following percutaneous implantation, preferably by a medical physician, adjustments to the operating parameters of the control unit may be implemented to optimize control of volume reduction (such as incontinence leakage). The adjustment may be performed at any time during the lifetime of the device using a wireless remote control, preferably as known in the art.
Advantageously, the energy source is a battery and the volume of the energy source is less than 20cm3Preferably less than 15cm3More preferably less than 12cm3. Such implantable batteries are, for example, lithium iodine or lithium manganese dioxide primary batteries as used in pacemakers, or lithium ion or lithium polymer rechargeable batteries commercially available from GreatBatch, Litronik and other companies. The energy transfer system required to charge the battery is preferably via a wireless connection. Such a system may include a charging unit as a belt, the charging unit including an external battery. The patient should wear the charging unit for several hours in order to charge the implanted battery. The energy should be transmitted wirelessly via a suitable antenna into the implanted battery.
The
The
The
The mechanical transmission means 8 for example comprise a
Thus, the
In a preferred embodiment, the nut is rotatably mounted into the
Said
It should be noted that the magnetic coupling between the
Alternatively, instead of male-female type means (such as the tubular receptacle 4 and the tubular sleeve 5 just described) further fastening means may be considered. Such fastening means may for example comprise a corrugated slide or a helical thread allowing a simple adjustment of the
Fig. 5 and 6 show an alternative embodiment for connecting the flexible transmission means 12 of the
As shown in fig. 6, the
The tubular seat 3g is configured as a female connection component for the connector 13 to guide the connector into engagement with the connection end 81c of the
The connector 13 comprises a plunger 131, which shows a substantially cylindrical body 131a extending longitudinally within a chamber of a protective casing 132, preferably made of the same biocompatible flexible material as the sheath 122 of the
Advantageously, the connecting rod 132 may translate within the plunger 131, but this displacement is limited by the toothed configuration of the toothed portion which engages with an internal hook member which extends radially inwardly from the body 131a of the plunger. The hook-shaped members may be released from the toothed portion by applying pressure as indicated by arrow F in fig. 5.
The head 131b of the plunger 131 is cylindrical and is a sliding fit inside the tubular seat 3 g.
To minimize fluid ingress between the coupler 13 and the seat tube 3g, one or more (two in this example) sealing rings 76 are provided in corresponding grooves in the inner wall of the seat tube 3g, which are in contact with the outer portion of the plunger head 131 b.
Upon insertion of plunger head 131b into seat 3g, connection head 132b is attached to distal tip 81c of
The
In this configuration, it is particularly easy to connect the artificial
More importantly, now with the
Although the present invention has been described in terms of particular embodiments, variations may be made thereto without departing from the scope of the invention as defined by the appended claims.