JP4328681B2 - Subcutaneous implanter unit - Google Patents

Description

  The present invention relates to a subcutaneous implanter unit including a state detector for a subcutaneous implanter for detecting an operation setting state of a medical device implanted, for example, subcutaneously.

  Currently, in the treatment of hydrocephalus, for example, a so-called “valve device” is used which discharges cerebrospinal fluid from the brain to the abdominal cavity, venous system, or other demand space in a state where the pressure is adjusted to an appropriate level. A “shunt operation” has been performed, and various types of valve devices have been proposed.

Such a valve device is required to have a function of adjusting the pressure of, for example, cerebrospinal fluid, and includes, for example, a magnet and uses a change in the magnetic field applied to the magnet from the outside. A pressure adjusting mechanism configured to adjust the operating pressure is used.
Specifically, for example, in response to a magnetic field pulse applied from outside the body in which the valve is embedded, the force pressing the valve member against the valve seat is increased or decreased by a finite change, thereby increasing or decreasing the pumping pressure by a finite change. Adjusting a branch valve having a stepped magnetic field adjusting means (see Patent Document 1) and a type of branch valve having one or more members configured to move under the influence of a magnetic field That uses a method of indirectly adjusting the pumping pressure of the branch valve (see Patent Document 2), or a long elastic member that is fixed at the base end and abuts against the valve body. A fulcrum is provided between the body and both ends of the elastic body, which is practically linearly movable along the longitudinal direction of the elastic body, and bends the elastic body in a specific direction between both ends of the elastic body. Having a movable body (Patent Literature) Reference.), And the like.
Japanese Patent Publication No. 06-071475 JP 09-117501 A JP 2001-104470 A

In such a valve device, for example, a rotating body such as an eccentric cam is rotated by a change in a magnetic field, and a force by which the valve by an appropriate pressing member is pressed against the valve seat is adjusted by a displacement generated as the rotating body rotates. In this way, the operating pressure of the valve is adjusted, but in order for the valve device to function under proper operation setting conditions, it is necessary to check the contact state between the rotating body and the pressing member. Is done. Conventionally, for example, a method for confirming the operation setting conditions of the valve device embedded under the skin by imaging with an X-ray imaging device, a method for confirming the operation setting conditions of the valve device by the orientation of a compass, etc. Is being used.
However, for example, when the operation setting condition of the valve device is confirmed using an X-ray imaging apparatus, the X-ray imaging apparatus itself is expensive, and a room capable of sufficiently managing radiation is required. It is.
In addition, when using, for example, an azimuth magnet to check the direction of the magnetic force of a magnet embedded in the valve device, the valve device itself needs to be provided with a magnet. Since the valve device has problems such as malfunction caused by the influence of magnetism by other devices such as an MRI diagnostic device, and may adversely affect the MRI diagnostic image. , You will be restricted in use.

As described above, there is no known method for easily confirming the operation setting state of the valve device configured to be able to change the operation condition from the outside without using magnetism. .
Further, the present invention is not limited to the valve device as described above, and the same applies to medical devices that are implanted under the skin and whose operation conditions are adjustable from the outside.

  The present invention has been made based on the circumstances as described above, and can easily detect the operation setting state of the subcutaneous implanter implanted under the skin, and therefore, the subcutaneous implanter can be reliably and appropriately operated. It is an object to provide a subcutaneous implanter unit that can be maintained in operating conditions.

The subcutaneous implanter unit of the present invention includes a subcutaneous implanter that is implanted subcutaneously, and a state detector for the subcutaneous implanter that detects an operation setting state of the subcutaneous implanter in a state of being implanted subcutaneously. A subcutaneous implanter unit comprising:
The subcutaneous implanter is configured so that the operation setting can be changed from the outside , and the subcutaneous implanter is formed with a reflective surface or an inclined surface that reflects light from the light source,
The state detection device has a light source that emits light from the outside to the subcutaneous implanter ,
By detecting light reflected by the reflecting surface or the inclined surface of the the implanted device, and detects the operation setting status of the implanted device.

In the subcutaneous implanter unit of the present invention, the light source can be a laser light source or a light source that emits light in the near infrared region.
Further, the state detection device has one or a plurality of light sources and a plurality of light receiving elements, and is based on the position of the light receiving element where the reflected light or scattered light from the reflecting surface or inclined surface of the subcutaneous implanter is most strongly detected. Thus, the operation setting state of the subcutaneous implanter can be detected. When the operation setting state of the subcutaneous implanter is detected visually, the positional relationship between the position and orientation of the subcutaneous implanter itself and the emission position of the light reflected by the reflective surface or inclined surface of the subcutaneous implanter is determined. Based on this, the operation setting state of the subcutaneous implanter can be detected.

Further, the subcutaneous implanter unit of the present invention includes a valve body, and a pressing member made of an elastic body provided in a state in which one end portion is brought into contact with the valve body and biased in a direction of pressing the valve body against the valve seat. It can be used to detect the operation setting state of a subcutaneously implantable valve device comprising a pressure adjusting mechanism that adjusts the operating pressure of the valve body.
In such a case, the pressure adjustment mechanism in the subcutaneously implantable valve device includes a rotating body having an inclined surface or a reflecting surface provided so as to contact the pressing member, and a power transmission member that transmits power to the rotating body. The linear motion of the power transmission member is converted into the rotational motion of the rotating body, and the pressing force of the pressing member against the valve body is adjusted by the displacement of the contact position between the rotating body and the pressing member caused by the rotation of the rotating body. This has the function of adjusting the operating pressure of the valve body, and detects the direction of the reflected or scattered light from the reflecting surface or inclined surface provided on the rotating body, thereby contacting the rotating body with the pressing member. By detecting the state, it is possible to detect the operation setting state of the subcutaneous implantable valve device.

Further, the subcutaneous implanter unit of the present invention can be used to detect the operation setting state of the subcutaneous implantable valve device including the flow rate adjusting mechanism.
In such a case, the flow rate adjustment mechanism in the subcutaneous implantable valve device has a power transmission mechanism that converts linear motion due to pressure or displacement applied from the outside through the skin into rotational motion of the rotating body, and the rotation The function of adjusting the flow rate of the fluid by adjusting the size of the cross-sectional area of the flow path of the fluid introduced into the apparatus by the displacement caused by the rotation of the body, and the reflection surface provided on the rotating body or By detecting the direction of the reflected light or scattered light from the inclined surface, it is possible to detect the restricted state of the fluid flow in the flow path, and thereby to detect the operation setting state of the subcutaneous implantable valve device.

  According to the subcutaneous implanter unit of the present invention, the operation setting state of the subcutaneous implanter can be easily confirmed based on the direction of the reflected energy to be detected. By making more changes, the subcutaneous implanter can be reliably maintained at appropriate operating conditions.

  Hereinafter, for example, for the purpose of treating hydrocephalus, brain tumor, subarachnoid cyst and the like, the pressure of the relevant fluid in the body can be adjusted non-invasively, for example, ventricle-abdominal shunt, lumbar spine- An embodiment applied when detecting an operation setting state of a subcutaneously implanted valve device that is surgically implanted in a body as a shunt valve for an abdominal cavity shunt, a ventricle-ventricular shunt, or the like will be described in detail.

<Subcutaneous implantable valve device>
FIG. 1 is a plan view schematically showing a configuration of an example of a subcutaneous implantable valve device constituting the subcutaneous implanter unit of the present invention, and FIG. 2 is a configuration example of a pressure adjusting mechanism in the subcutaneous implantable valve shown in FIG. Is a front view showing a state in which a part of the rotor is broken, and FIG. 3 is a cross-sectional view taken along line AA shown in FIG.
This subcutaneously-embedded valve device (hereinafter also simply referred to as “valve device”) 10 has a flat plate-like base 11 provided on one side with a channel forming mass 12 having a bypass channel 13 formed therein. And a ball valve 15 which is a valve body supported by a valve seat made of a spherical support portion 13A formed at the outlet side opening edge portion of the bypass flow path 13 and one end portion of the ball valve 15 abuts against the ball valve 15. In addition, the other end is brought into contact with the outer peripheral surface of the rotor 25 in the pressure adjusting mechanism 20 described later, and the pressing member 16 is provided in a state of urging the ball valve 15 in the direction of pressing the valve seat. A pressure adjusting mechanism 20 that adjusts the operating pressure of the ball valve 15 by adjusting the pressing force to the ball valve 15 is provided.
Here, the material constituting the base 11 and the flow path forming block 12 is not particularly limited as long as it has biocompatibility and does not exhibit magnetism or weak magnetism. 11 can be exemplified by metal materials such as titanium, titanium-nickel alloy (Ti-Ni alloy), cobalt-chromium alloy (Co-Cr alloy), and stainless steel. Examples of the material constituting the lump 12 include resin materials such as polypropylene (PP), ABS resin, and polyacetal (POM).
Moreover, as a material which comprises the ball valve 15, a ruby, a sapphire, a diamond, ceramics etc. can be illustrated, for example.

The pressing member 16 is made of a long plate-like elastic body such as a flat U-shaped leaf spring, for example, and the arc-shaped connecting portion 16A of the leaf spring is in contact with the outer peripheral surface of the rotor 25 and has one tongue. One end portion of the piece portion 16B is in contact with the ball valve 15, and one end portion of the other tongue piece portion 16C is fixed to the support member 18.
One tongue piece portion 16B is curved in an arc shape so that the entire central portion thereof is pressed toward the ball valve 15 side by being pressed from the opposite side where the ball valve 15 is positioned by the columnar member 17 forming a fulcrum. ing.
The material constituting the pressing member 16 is not particularly limited as long as it has biocompatibility and does not exhibit magnetism or weak magnetism. For example, stainless steel, titanium, titanium-nickel alloy ( Ti-Ni alloy), cobalt-chromium alloy (Co-Cr alloy) and the like can be exemplified.

  The pressure adjustment mechanism 20 converts, for example, a linear motion of the power transmission member due to pressure applied through the patient's skin S into a rotational motion of the rotating body, and a pressing member according to a displacement amount set according to the rotational amount of the rotating body. The operating pressure of the ball valve 15 is adjusted by adjusting the pressing force of the sixteen ball valves 15, thereby adjusting the fluid pressure to an appropriate magnitude.

In this pressure adjustment mechanism 20, a cylindrical stator 21 that functions as an operation restricting member is inserted into a first coil spring 40 having a lower end portion disposed on one surface of the base 11, and the cylindrical shaft 21 </ b> A is a base. 11 is fixed to the base 11 so as to extend in a direction perpendicular to the direction 11 (upward in FIG. 2).
At the upper end portion of the outer peripheral surface of the stator 21, a plurality of, for example, eight columnar guide pieces 22 extending downward in the axial direction from the upper end edge are formed in a state of being spaced apart from each other at equal intervals (center angle 45 °). The lower end portion of each guide piece 22 has a tapered shape having an inclined surface 22A facing the direction along the circumferential surface.
The inclined surfaces 22A of the respective guide pieces 22 have the same angle of inclination and have the same level position in the axial direction.
In the stator 21, a plurality of, for example, four guide grooves 23 extending axially downward from the upper end edge, and the circumferential surface between the guide pieces 22 with the two guide pieces 22 positioned between the adjacent guide grooves 23. Are formed at regular intervals (center angle 90 °).

Reference numeral 25 denotes a rotor made of, for example, an eccentric cam, which is a rotating body, and has a circular opening 26 centered on the rotation center axis C as shown in FIG. On the inner peripheral surface of the opening 26, a plurality of columnar keys 27 extending in the axial direction each having an upper end projecting radially inward are substantially hemispherical at regular intervals (center angle 45). °) Formed at spaced positions.
In the rotor 25, the stator 21 is inserted into the opening portion 26, and the opening edge portion on the lower surface is supported by the first coil spring 40 in a state where each key 27 is engaged with each of the guide pieces 22 of the stator 21. The rotation center axis C is provided coaxially with the cylindrical shaft 21A of the stator 21. In this state, the upper end portion of the stator 21, for example, the upper end portion of the guide piece 22 protrudes upward from the upper surface of the rotor 25, and the guide groove 23 of the stator 21 protrudes downward from the lower surface of the rotor 25.
In the rotor 25, an inclined surface 28 is formed on a part of the upper surface located on the patient's skin S side so that the level level in the axial direction with respect to the base 11 becomes lower toward the outer side in the radial direction. Specifically, as will be described later, the rotor 25 is gradually stepped at a predetermined rotation angle (eight steps in the illustrated example) by the key 27 moving sequentially in the groove portion 24 formed between the guide pieces 22 of the stator 21. In this example, it is adjacent to the downstream side in the rotational direction from the circumferential position (a) at which the separation distance between the contact point and the rotational center position at the contact position P between the pressing member 16 and the rotor 25 is maximum. It is formed at a circumferential position (b).

Reference numeral 30 denotes a power transmission member that linearly moves by pressure applied through the skin S of the patient, for example, and is a bottomed cylindrical plunger having an open bottom surface. Each of the plurality of, for example, four of the columnar ribs 33 each having a tapered shape having an inclined surface 32 whose bottom end faces the direction along the circumferential surface is formed at a position corresponding to the guide groove 23 of the stator 21. Has been. The inclined surfaces 32 of the respective ribs 33 have the same level position in the axial direction, and have the same inclination angle and face the same direction as the inclined surface 22A of the guide piece 22 in the stator 21.
In the plunger 30, the tubular portion 31 is inserted into the stator 21 with each rib 33 accommodated along the guide groove 23 of the stator 21, and the inner end surface of the tubular portion 31 is the interior of the stator 21. The plunger 30 is initially supported by the elastic force (restoring force) of the second coil spring 41 that is compressed by being pressed from above. It is linearly moved (reciprocated) so as to return to the axial level position in the state.
In the above, the material constituting the stator 21, the rotor 25, and the plunger 30 constituting the pressure adjusting mechanism 20 is particularly limited as long as it has biocompatibility and does not exhibit magnetism or is weak in magnetism. For example, resin materials such as polypropylene (PP), ABS resin, polyacetal (POM), ceramics, titanium, titanium-nickel alloy (Ti-Ni alloy), cobalt-chromium alloy (Co-Cr alloy), stainless steel Etc. can be illustrated.

  Here, a numerical example of the configuration of the valve device 10 will be described. The maximum value (maximum diameter) of the distance between the contact position P of the rotor 25 with the pressing member 16 and the rotation center position is 4.0 mm. The minimum value (minimum diameter) is 2.6 mm, the amount of displacement generated when the rotor 25 is rotated by a single linear movement of the plunger 30 is 0.2 mm, and the number of steps of the rotor 25 is eight (the circumferential position of the rotor) In each of (a) to (h), the pressing member 16 can be contacted.

Hereinafter, the operation of the valve device will be described.
As described above, the valve device 10 is usually covered with an exterior made of, for example, silicone rubber. As described above, for example, for the treatment of hydrocephalus, brain tumor, subarachnoid cyst, etc. Can be adjusted non-invasively, for example, as a shunt valve for ventricular-abdominal shunt, lumbar-abdominal shunt, ventricular-ventricular shunt, etc. Is a state in which the ball valve 15 is pressed against the valve seat by the pressing force adjusted to an appropriate size by the pressing member 16, and the pressure of the fluid introduced into the bypass passage 13 (pumping) When the pressure is higher than the operating pressure of the ball valve 15, the ball valve 15 is separated from the valve seat and the fluid is discharged (outflow), thereby connecting to the upstream side (inlet side) of the bypass flow path 13. The pressure of the fluid for example in the tube is, the downstream side of the bypass passage 13 to adjust the fluid pressure in the tube connected to the (outlet side) is performed. Here, the valve device 10 is implanted in a posture in which the base 11 is substantially horizontal to the skin S, for example, at a depth of about 1 cm, for example, under the skin of the patient.

  Thus, it becomes necessary to adjust the operating pressure of the ball valve 15 (the operating condition of the valve device 10), and the operating pressure of the ball valve 15 is adjusted by adjusting the pressing force of the ball valve 15 by the pressing member 16. At this time, first, as shown in FIG. 5, the plunger 30 in the pressure adjustment mechanism 20 is pressed with an appropriate pressure through the skin or the exterior, so that the plunger 30 has the rib 33 and the guide groove of the stator 21. 23, the key 27 of the rotor 25 is pressed downward while the second coil spring 41 is compressed. As a result, as shown in FIG. 6, while the first coil spring 40 is compressed, the entire rotor 25 is moved downward in the axial direction, and the engagement between the key 27 of the rotor 25 and the guide piece 22 of the stator 21 is released. At the same time, the key 27 is moved from the position a to the position b along the inclined surface 32 of the rib 33 of the plunger 30. As a result, the rotor 25 has a predetermined rotation angle θ1 (22.5 ° in the illustrated example). Thus, each key 27 is moved to a position opposite to each of the guide pieces 22 of the stator 21. Here, the displacement amount (movement amount) of the plunger 30 with respect to the axial direction is not particularly limited as long as the engagement between the key 27 of the rotor 25 and the guide piece 22 of the stator 21 can be released. In practice, the thickness is set to 0.5 to 6.0 mm.

Thereafter, as shown in FIG. 7, the plunger 30 is moved upward by the elastic force (restoring force) of the second coil spring 41 while the rib 33 is guided along the guide groove 23 of the stator 21. While returning to the axial level position in the initial state, the rotor 25 is biased upward in the axial direction by the elastic force (restoring force) of the first coil spring 40, so that the key 27 of the rotor 25 is moved to the stator 21. While moving from the position b to the position c along the inclined surface 22A of the guide piece 22, the entire rotor 25 is moved upward, and the magnitude of the predetermined rotation angle θ2 in the circumferential direction (22.5 ° in the illustrated example). As a result, each key 27 of the rotor 25 is moved to the adjacent groove 24 on the downstream side in the rotational direction from the groove 24 between the guide pieces 22 in the initial state. The guide pieces 22 are engaged with each other.
Accordingly, in this valve device 10, the rotor 25 is rotated by a rotation angle (θ1 + θ2) (45 ° in the illustrated example) by a single linear motion of the plunger 30, thereby causing the outer circumferential surface of the rotor 25 to be rotated. Due to the cam action, at the contact point P between the pressing member 16 and the rotor 25, the separation distance (diameter size) between the contact point and the rotation center position is reduced, and is 0.2 mm on the radially inner side of the rotor 25. A displacement occurs, and the pressing force of the rotor 25 against the pressing member 16 is adjusted. In accordance with this, the pressing force of the pressing member 16 against the ball valve 15 is adjusted. The pressure of the introduced fluid is adjusted. Here, the operating pressure of the ball valve 15 can be adjusted to be, for example, 10 Pa or more. In the above configuration, for example, the pressure is adjusted within the range of 147.1 to 1961.3 Pa (15 to 200 mmAq). It is possible.

  As described above, in this valve device 10, the meshing position of the key 27 of the rotor 25 and the guide piece 22 of the stator 21 (the position of the groove 24 between the guide pieces 22) is rotated by a single linear movement of the plunger 30. By moving sequentially with respect to the direction, the displacement amount of the contact position P with the pressing member 16 accompanying the rotation of the rotor 25 is indicated stepwise, for example, in the circumferential positions (a) to (h) in FIG. It is adjusted in 8 steps. Therefore, the operation pressure of the ball valve 15 can be adjusted to an appropriate magnitude by repeatedly performing the pressing operation (pressure adjusting operation) of the plunger 30 as necessary.

  Thus, according to the valve device 10 having the above-described configuration, a mechanical power transmission mechanism in which the rotor 25 is rotated when the pressure adjusting mechanism 20 is given pressure from the outside through the skin S of the patient, for example. Since the operation pressure of the ball valve 15 is adjusted by the above, the operation setting conditions such as the operation pressure of the ball valve 15 set in advance are changed by the influence of magnetism of other devices, etc. Can be operated in a state in which the pressure of the body fluid (fluid) is adjusted to an appropriate magnitude. In addition, the valve device 10 itself can reduce adverse effects on the diagnosis of the MRI apparatus and the like.

  Furthermore, since the operation pressure of the ball valve 15 is configured to be adjustable in steps, the operation pressure of the ball valve 15 can be reliably set to an appropriate magnitude according to the purpose.

Further, the pressure adjustment mechanism 20 uses the elastic force generated by the inclined surface 32 of the rib 33 of the plunger 30, the inclined surface 22 </ b> A of the guide piece 22 of the stator 21, and the first coil spring 40 and the second coil spring 41. 30 has a function of converting the linear motion of the rotor 30 into the rotational motion of the rotor 25, the rotor 25 can be operated smoothly, and the contact portion between the rib 33 of the plunger 30 and the key 27 of the rotor 25 and the rotor The degree of wear of the contact portion between the 25 key 27 and the guide piece 22 of the stator 21 can be suppressed to a small level, and the required pressure adjustment can be performed reliably.
Further, after the operation pressure of the ball valve 15 is set, the rotation of the rotor 25 is prohibited by engaging the guide piece 22 of the stator 21 and the key 27 of the rotor 25. Thus, it is possible to reliably prevent malfunction. Since the inclined surface 32 of the rib 33 of the plunger 30 and the inclined surface 22A of the guide piece 22 of the stator 21 are formed so as to face each other, the rotational direction of the rotor 25 is restricted to one direction. The amount of rotation of the rotor 25 corresponding to the number of pressing operations of the plunger 30, that is, the adjustment amount of the pressing force of the rotor 25 with respect to the pressing member 16 can be easily grasped, and the operating pressure of the ball valve 15 is reliably increased to an appropriate level. Can be adjusted.
Further, since the upper end portion of the key 27 of the rotor 25 is hemispherical, a state of substantially point contact with the inclined surface 32 of the rib 33 of the plunger 30 or the inclined surface 22A of the guide piece 22 of the stator 21 is obtained. Therefore, the frictional resistance is reduced and the operation can be performed smoothly.

  The pressure adjusting mechanism 20 includes all the constituent members constituting the pressure adjusting mechanism 20, specifically, the stator 21, the rotor 25, the plunger 30, the first coil spring 40, and the second coil spring 41. Therefore, the entire valve device 10 can be prevented from increasing in size.

<Subcutaneous implant device status detection device>
The state detection device constituting the subcutaneous implanter unit of the present invention irradiates the above-described valve device 10 with ultrasonic energy or light energy from the outside, and detects the reflected energy from the valve device 10, thereby The operation setting state of the apparatus 10 is detected.

FIG. 8 is a cross-sectional view showing an outline of a configuration of an example of a state detecting device for a subcutaneous implanter constituting the subcutaneous implanter unit of the present invention in an enlarged manner.
This subcutaneous implanter state detection device (hereinafter simply referred to as “state detection device”) 50 is formed with a light irradiation port 51A having an opening edge in close contact with the patient's skin S, and is entirely dome-shaped. The casing 51 is provided with a laser light source 52 for irradiating the valve device 10 with laser light transmitted through the skin S of the patient and a light receiving element 53 for receiving reflected light from the valve device 10. It is configured.

  The laser light source 52 is configured by a laser diode that irradiates laser light having a wavelength range of 500 to 1000 nm, for example, and is displaced outwardly in the radial direction of the rotor 25 from the rotation center axis C of the rotor 25 according to the valve device 10. In this position, the laser beam is radiated from the direction perpendicular to the upper surface of the rotor 25.

  The light receiving element 53 is configured by, for example, a photodiode, and is a position set according to the inclination angle of the inclined surface 28 formed on the rotor 25 of the valve device 10, that is, a laser from the laser light source 52. When the light I1 passes through the skin S and is irradiated onto the inclined surface 28 of the rotor 25 of the valve device 10, the light receiving surface faces the reflection angle α direction of the reflected light I2 reflected by the inclined surface 28. Is provided.

In the state detection device 50, the operation setting state of the valve device 10, specifically, the contact state between the rotor 25 and the pressing member 16 in the pressure adjustment mechanism 20 of the valve device 10 is detected as follows. . That is, the state detection device 50 is positioned with respect to the embedded position of the valve device 10 in a state where the orientation of the valve device 10 itself embedded under the skin is visually confirmed based on, for example, the outer shape of the valve device 10. In the combined state, it is placed in close contact with the surface of the patient's skin S. In this state, the laser light is irradiated by the laser light source 52, so that the laser light passes through the skin S and the upper surface of the rotor 25. Is irradiated.
At this time, when the reflected light I2 from the rotor 25 passes through the skin S and is emitted to the outside and received by the light receiving element 53, the laser light I1 emitted from the light source 52 is applied to the inclined surface 28 of the rotor 25. As a result, the position of the inclined surface of the rotor 25 relative to the direction of the valve device 10 itself (the direction of the rotor 25) is confirmed. On the other hand, when the light reflected by the rotor 25 is not detected by the light receiving element 53, it is confirmed that the laser light I1 emitted from the light source 52 is in a state of being irradiated to a position other than the inclined surface 28 of the rotor 25. By rotating the state detection device 50 around the rotation center axis C of the rotor 25 to reset the arrangement position and repeating the above operation as necessary, the reflected light from the inclined surface 28 of the rotor 25 is received by the light receiving element. The position detected by 53 is searched, and thereby the position of the inclined surface 28 of the rotor 25 with respect to the direction of the entire valve device 10 is confirmed.
Therefore, the position of the inclined surface 28 of the rotor 25 with respect to the direction of the entire valve device 10 is detected based on the direction of the reflected light, whereby the circumference on the outer peripheral surface of the rotor pressing the pressing member 16 is detected. The direction position is specified, and the operation setting state of the valve device 10 is detected.

As described above, according to the subcutaneous implanter unit including the state detection device 50 configured as described above, the orientation of the valve device 10 embedded in the skin (direction of the contact position between the rotor and the pressing member with respect to the rotation center axis) In the state in which the pressure is confirmed, by detecting the position of the inclined surface 28 of the rotor 25 with respect to the direction of the entire valve device 10 (direction of the rotor 25), the circumferential position on the outer peripheral surface of the rotor 25 pressing the pressing member 16 Thus, the magnitude of the pressing force applied to the pressing member 16 by the rotor 25 can be confirmed, whereby the operation setting state of the valve device 10 can be confirmed.
Therefore, for example, even when it becomes necessary to change the operating conditions of the valve device 10, the valve device 10 can be operated without performing an action such as surgically removing the valve device 10 and resetting the operating conditions. By repeating the pressure adjustment operation by the pressure adjustment mechanism 20 at 10 as necessary, the valve device 10 can be reliably maintained at an appropriate operating condition.

As mentioned above, although embodiment of this invention was described, this invention is not limited to said embodiment, A various change can be added.
For example, in the above-described embodiment, a configuration has been described in which an inclined surface is formed at a required position on the upper surface of the rotor, and the reflected light is detected by the light receiving element using the reflection characteristics of the rotor itself. For example, a reflection surface may be formed on the upper surface by, for example, forming a reflection film, and the light reflected by the reflection surface may be detected by the light receiving element.
Further, the light energy given to the subcutaneous implanter such as a bulb device is not limited to that by a laser light source, for example, even if it is a light source that emits near-infrared rays having a wavelength range of 700 to 1300 nm. In addition, a sufficient effect can be obtained. In such a case, for example, on the rotation center axis of the valve device, one near infrared light source is arranged so that the near infrared light transmitted through the skin is irradiated to the entire upper surface of the rotor, and a plurality of light receiving elements are arranged. The position of the inclined surface of the rotor with respect to the orientation of the valve device itself by detecting the position of the light receiving element that is disposed in a state of being separated in the rotational direction about the rotation axis and detecting the reflected light from the inclined surface of the rotor (Orientation of the rotor) can be confirmed, whereby the position of the contact position between the rotor and the pressing member determined by the valve device itself and the position of the circumferential position where the inclined surface of the rotor is formed Based on the relationship, the magnitude of the pressing force applied to the pressing member by the rotor can be confirmed, and the operation setting state of the valve device can be known.

Furthermore, in the above-described embodiment, for example, as a method for detecting reflected light of laser light emitted from a laser light source, that is, as a method for detecting the operation setting state of a subcutaneous implanter, for example, as shown in FIG. The light sources 52 are disposed so that the laser light irradiation spots are formed at positions (indicated by dots in FIG. 4) that are arranged at equal intervals in the circumferential direction on the upper surface of the rotor 25. Correspondingly, a plurality of light receiving elements 53 are arranged, and the operation setting state of the valve device 10 is detected based on the position of the light receiving element 53 where the reflected light I2 from the inclined surface 28 of the rotor 25 is detected. it can.
In the subcutaneous implanter state detection device 60 having such a configuration, the orientation of the entire valve device 10 is visually confirmed, and the position of the light receiving element where the reflected light I2 from the inclined surface 28 of the rotor 25 is detected is determined. By detecting, the position of the inclined surface 28 of the rotor 25 with respect to the orientation of the valve device 10 itself can be confirmed, whereby the contact between the rotor 25 and the pressing member 16 determined by the orientation of the valve device 10 itself. Based on the positional relationship between the direction of the position and the direction of the circumferential position where the inclined surface 28 of the rotor 25 is formed, the magnitude of the pressing force applied to the pressing member 16 by the rotor 25 can be confirmed. You can know the operation setting status. In FIG. 9, the same components as those shown in FIG. 8 are denoted by the same reference numerals for the sake of convenience.
Further, depending on the surface condition on the upper surface of the rotor 25, the light reflected by the inclined surface 28 or by the influence of light, such as the skin, the exterior, or cerebrospinal fluid, becomes scattered light. In this case, for example, a plurality of light receiving elements can be arranged as described above, and the state of the rotor 25 can be detected based on the position (direction) of the light receiving element where the intensity of the scattered light detected is maximum.

In addition, the direction of the entire valve device is not confirmed by optically detecting reflected light or scattered light by a light receiving element, but by visually confirming the direction of reflected light reflected by the reflecting surface or inclined surface of the valve device. Thus, the position of the inclined surface of the rotor with respect to can be detected, and thereby a method of detecting the operation setting state of the valve device can be used.
Specifically, the positional relationship between the orientation of the valve device (direction of the contact position between the rotor and the pressing member) and the emission position of the reflected light from the inclined surface or reflecting surface of the rotor in the valve device is visually confirmed. By confirming the position of the inclined surface of the rotor with respect to the direction of the valve device itself, the direction of the contact position between the rotor and the pressing member determined by the direction of the valve device itself and the inclined surface of the rotor are determined. Based on the positional relationship with the formed circumferential position, the magnitude of the pressing force applied to the pressing member by the rotor can be confirmed, and the operation setting state of the valve device can be known. Here, when the laser beam is irradiated to the inclined surface of the rotor, the emission position of the reflected light is formed at a position different from the incident position, and on the other hand, at a position other than the inclined surface of the rotor. When the laser beam is irradiated, the emission position is formed at substantially the same position as the incident position. Therefore, the incident position and the emission position of the laser beam on the surface of the patient's skin in the valve device are mutually different. When the difference is confirmed, the position of the inclined surface in the rotor can be confirmed.

Further, in the state detection device constituting the subcutaneous implanter unit of the present invention, even when the ultrasonic energy is used instead of the light energy, the operation setting state of the subcutaneous implanter is detected. It can be carried out.
FIG. 10 is a plan view schematically showing the configuration of an example of a subcutaneous implantable valve device that is a detection target of a state detection device including an ultrasonic energy source that constitutes the subcutaneous implanter unit of the present invention.
In this subcutaneously implantable valve device 10, the rotor 65 in the pressure adjusting mechanism 20 has a detection part 67 having a part made of a material different from that of the other parts. For example, it is made of plastic such as polyacetal, and the detection portion 67 is made of metal such as stainless steel. The basic configuration of the valve device 10 is the same as that shown in FIG. 1, and the same reference numerals are given to the same components for convenience.
When detecting the operation setting state of the subcutaneous implantable valve device 10 as described above, ultrasonic waves are radiated to the subcutaneous implantable valve device 10 from the outside, the reflected waves from the rotor 65 are received, and the reflection characteristics due to the difference in material are obtained. By detecting the difference as visual information, the orientation of the rotor 65 relative to the orientation of the subcutaneous implantable valve device 10 itself is detected, whereby the rotor 65 and the pressing member determined by the orientation of the subcutaneous implantable valve device 10 itself. The magnitude of the pressing force of the rotor 65 against the pressing member 16 can be confirmed based on the positional relationship between the direction of the contact position with the rotor 16 and the direction of the circumferential position where the detection portion 67 of the rotor is formed. Therefore, the operation setting state of the valve device 10 can be detected.

Further, the valve device is not limited to the above-described configuration, and for example, as shown in FIGS. 11 and 12, the rotor that is a rotating body in the pressure adjustment mechanism may be configured by a spiral stepped cam. .
More specifically, the pressure adjusting mechanism 80 in the valve device 70 is provided with a cylindrical shaft member 81 fixed to the base 11, and an internal coil spring (not shown) is provided inside the shaft member 81. The coil shaft is disposed in a state where it is coaxial with the cylindrical shaft of the shaft member 81.
Reference numeral 75 denotes a pressing member that urges the ball valve 15 in a direction in which the ball valve 15 is pressed against the valve seat. For example, two plate-like support pieces 71 that extend in parallel at positions aligned in the plane direction are connected via an arc-shaped connecting portion 72. The plate-shaped pressing force urging portion 73 is formed continuously from the arcuate connection portion 72 and extends along the longitudinal direction of the support piece 71, and is configured by one end of the pressing force urging portion 73. The other portion (the arc-shaped connecting portion 72) is in contact with the upper surface of the rotating body (rotor 85) in the pressure adjusting mechanism 80.

Reference numeral 85 denotes a rotor formed of a spiral staircase cam having a circular opening 86 centered on the rotation center axis C, and the shaft member 81 is a cylindrical shaft of the shaft member 81 in the opening 86. And the rotation center axis C of the rotor 85 is inserted and provided coaxially. In the inner peripheral surface of the opening 86 of the rotor 85, a plurality of, for example, eight of the columnar keys 87 protruding radially inward are spaced apart from each other at equal intervals (center angle 45 °). A spiral staircase in which the outer peripheral edge portion 88 of the upper surface of the leaf spring against which the arc-shaped connecting portion 72 abuts changes the level position in the axial direction with respect to the base 11 stepwise according to the amount of rotation of the rotor 85. It is made into a shape.
A reflection surface or an inclined surface (not shown) that reflects light from the light source in the state detection device is formed at one end of the spiral staircase portion of the rotor 85.

Reference numeral 90 denotes a plunger that is a power transmission member that linearly moves, for example, by pressure applied through the skin. A plurality of, for example, two columnar upper ribs 91 are provided in the axial direction on the upper end portion of the outer peripheral surface of the plunger 90. In an extended state, they are formed apart from each other in the circumferential direction, and a plurality of, for example, four columnar lower ribs 92 are formed at the lower end portion at positions spaced apart from each other in the circumferential direction. Specifically, the upper rib 91 is positioned above a key at a symmetrical position across the key of the rotor 85 and the rotation center axis C in a state where one of the upper ribs 91 is aligned with an arbitrary key of the rotor 85. The lower ribs 92 are formed at two positions in the peripheral surface area between the upper ribs 91 and are spaced apart from each other at equal intervals, that is, in the peripheral surface area between the upper ribs 91. The groove 85 is formed at a position corresponding to each of the grooves 89 formed between the keys 87 of the rotor 85.
Each of the upper ribs 91 has a tapered shape having an inclined surface 91A having a lower end facing a direction along the circumferential surface of the cylindrical portion, and the inclined surfaces 91A of the upper ribs 91 have the same size. And the level position in the axial direction is the same.
Each of the lower ribs 92 has a tapered shape with an upper end having an inclined surface facing the same direction as the inclined surface 91A of the upper rib 91, and the inclined surfaces of the lower ribs 92 have the same size. And the level position in the axial direction is the same.
The plunger 90 is aligned with the key 87 of the rotor 85 corresponding to each of the upper ribs 91, whereby each of the lower ribs 92 is accommodated in a groove 89 formed between the keys 87 of the rotor 85. Is inserted into an annular groove formed by the outer peripheral surface of the shaft member 81 and the inner peripheral surface of the rotor 85, and an inner coil spring in which the inner end surface of the cylindrical portion is disposed inside the shaft member 81. It is supported by and provided.

  When detecting the operation setting state of the valve device having such a configuration, for example, as shown in FIG. 8 or FIG. By detecting the position of the light receiving element (the direction of the reflected light) where the reflected light reflected by the surface is detected, the operation setting state of the valve device can be detected.

  Furthermore, the state detection device constituting the subcutaneous implanter unit of the present invention has a power transmission mechanism that converts linear motion due to pressure or displacement applied from the outside through the skin into rotational motion of the rotating body, and the rotating body A subcutaneously embedded valve device comprising a flow rate adjusting mechanism having a function of adjusting the flow rate of the fluid by adjusting the size of the cross-sectional area of the flow path of the fluid introduced into the device by the displacement caused by the rotation of the fluid It can be applied when detecting the operation setting state.

As shown in FIG. 13, this subcutaneously-embedded valve device is discharged through a substantially linearly extending flow path 96 formed inside a flow path forming portion 96A provided on one surface of the base 11. For example, a flow rate adjusting mechanism 95 that adjusts the flow rate of body fluid such as cerebrospinal fluid is provided.
The flow path forming portion 96A has a recess 96B formed in a part of the inner peripheral surface of the flow path 96. The recess 96B has a pressing member insertion through-hole 96C that opens to the outer surface. Yes.
The recess 96B in the flow path 96 is provided with an elastic film 97A made of, for example, silicone rubber so as to close the pressing member insertion through-hole 96C from the inner surface side, thereby constituting a flow rate adjusting mechanism 95 described later. By being pressed by the pressing member 99A, a deformable flow path portion 96D configured so that the size of the cross-sectional area of the flow path 96 can be adjusted is formed. Reference numeral 97B denotes a pressure adjusting function film that alleviates the differential pressure between the inlet-side channel and the outlet-side channel that is generated when the deformable channel portion 96D is pressed by the pressing member 99A.
The flow rate adjusting mechanism 95 includes a pressing mechanism 98 that adjusts the size of the cross-sectional area of the deformable flow path portion 96D by pressing the variable shape flow path portion 96D with a pressing force adjusted to an appropriate size. The linear motion due to the pressure or displacement applied through the skin is converted into the rotational motion of the rotating body, and the pressing force applied to the deformable flow path portion 96D of the pressing mechanism 98 by the amount of displacement set according to the amount of rotation of the rotating body. And the flow of body fluid in the flow path 96 is restricted by adjusting the size of the cross-sectional area of the deformable flow path portion 96D by the displacement caused by the rotation of the rotating body. Thus, it has a function of adjusting the flow rate or flow rate of the body fluid to an appropriate size.
The pressing mechanism 98 is biased in a direction away from the elastic film 97A (upward in FIG. 13) by an elastic member 99B made of a coil spring.
The power transmission mechanism 110 converts the linear motion into the rotational motion of the rotating body, similarly to the pressure adjusting mechanism 20 in the valve device shown in FIG. 1, and applies the pressing force to the pressing member 99A due to the displacement caused by the rotation of the rotating body. The rotor 25, which is a rotating body, has the same configuration as the rotor 20 shown in FIG. 1, and the plunger 90, which is a power transmission member, has the same configuration as that shown in FIGS. It is what has. For convenience, the same components are denoted by the same reference numerals. A detection surface 28 </ b> A such as an inclined surface or a reflection surface is formed on a part of the upper surface of the rotor 25.

  When detecting the operation setting state of the subcutaneously embedded valve device having such a configuration, the direction of the valve device itself is visually confirmed, and thereafter, for example, as shown in FIG. 8 or FIG. For example, light energy is irradiated by one or a plurality of light sources, and the position of the light receiving element (the direction of the reflected light) where the reflected light reflected by the detection surface 28A in the rotor 25 is detected is detected. The position of the detection surface 28A of the rotor 25 with respect to the orientation of the rotor 25 can be confirmed, whereby the direction of the contact position between the rotor 25 and the pressing member 99A determined by the orientation of the valve device itself, and the detection surface 28A of the rotor 25 can be confirmed. The magnitude of the pressing force applied to the pressing member 99A by the rotor 25 can be confirmed based on the positional relationship with the direction of the circumferential position where is formed. Come, it is possible to know the operation setting state of the valve device 10.

  The subcutaneous implanter according to the subcutaneous implanter unit of the present invention is not limited to the subcutaneous implantable valve device, but a medical device that is used by being embedded in the subcutaneous structure in which the setting conditions can be adjusted from the outside, such as a cochlear implant, It can be applied to cardiac resynchronization devices, implantable cardioverter defibrillators (ICDs), spinal cord electrical stimulation devices, and the like.

It is a top view which shows the outline of a structure in an example of the subcutaneous implantation type | mold valve apparatus which comprises the subcutaneous implantation device unit of this invention. FIG. 2 is a front view showing a configuration example of a pressure adjusting mechanism in the subcutaneously embedded valve shown in FIG. 1 in a state where a part of a rotor is broken. It is AA sectional drawing shown in FIG. It is a top view which shows the example of 1 structure of a rotor. It is explanatory drawing which shows the positional relationship of each structural member in case a pressure adjustment mechanism exists in an initial state. It is explanatory drawing which shows the state by which the plunger was pressed. It is explanatory drawing which shows the state which the plunger returned to the level position of the axial direction in an initial state. It is sectional drawing which expands the principal part and shows the outline of the structure in an example of the state detection apparatus of the subcutaneous implanter which comprises the subcutaneous implanter unit of this invention. It is sectional drawing which expands the principal part and shows the outline of the structure in the other example of the state detection apparatus of the subcutaneous implanter which comprises the subcutaneous implanter unit of this invention. It is a top view which shows the outline of a structure in an example of the subcutaneous implantation type | mold valve | bulb which is the detection target of the state detection apparatus provided with the ultrasonic energy source which comprises the subcutaneous implantation equipment unit of this invention. It is a top view which shows the outline of a structure in the other example of the subcutaneous implantation type | mold valve | bulb which concerns on the subcutaneous implantation unit of this invention. It is a side view of the subcutaneous implantation type | mold valve apparatus shown in FIG. It is a top view which shows the outline of the structure in the further another example of the subcutaneous implantation type | mold valve | bulb which concerns on the subcutaneous implantation device unit of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Subcutaneous implantation type valve apparatus 11 Base 12 Mass for flow path formation 13 Bypass flow path 13A Support part 15 Ball valve 16 Press member 16A Arc-like connection part 16B One tongue piece part 16C The other tongue piece part 17 Columnar member 18 Support member DESCRIPTION OF SYMBOLS 20 Pressure adjustment mechanism 21 Stator 21A Cylindrical shaft 22 Guide piece 22A Inclined surface 23 Guide groove 24 Groove part 25 Rotor 26 Opening part 27 Key 28 Inclined surface 28A Detection surface 30 Plunger 31 Cylindrical part 32 Inclined surface 33 Rib 40 First coil spring 41 Second coil spring C Rotation center shaft 50 Subcutaneous implanter state detection device 51 Casing 51A Light irradiation port 52 Laser light source 53 Light receiving element I1 Irradiation laser beam I2 Reflected light S Patient skin 60 Subcutaneous implanter state detection device 65 Rotor 66 Base part 67 Detection part 70 Valve device Reference Signs List 71 Supporting piece 72 Arc-shaped connecting portion 73 Pressing force urging portion 75 Pressing member 80 Pressure adjusting mechanism 81 Shaft member 85 Rotor 86 Opening 87 Key 88 Outer peripheral edge portion 89 Groove portion 90 Plunger 91 Upper rib 91A Inclined surface 92 Lower rib 95 Flow rate Adjustment mechanism 96 Flow path 96A Flow path forming portion 96B Recess 96C Press member insertion through hole 96D Deformable flow path portion 97A Elastic film 97B Pressure adjustment function film 98 Press mechanism 99A Press member 99B Elastic member 100 Power transmission mechanism

Claims (10)

And the implanted device to be implanted subcutaneously, a hypodermic embedded unit comprising a state detection device of the implanted device for detecting the operation setting state of the hypodermic embedded device in a state of being implanted subcutaneously,
The subcutaneous implanter is configured so that the operation setting can be changed from the outside , and the subcutaneous implanter is formed with a reflective surface or an inclined surface that reflects light from the light source,
The state detection device has a light source that emits light from the outside to the subcutaneous implanter ,
By detecting light reflected by the reflecting surface or the inclined surface of the the implanted device, the implanted unit, characterized by detecting the operation setting status of the implanted device. The subcutaneous implanter unit according to claim 1, wherein the light source is a laser light source . The subcutaneous implanter unit according to claim 1, wherein the light source is a light source that emits light in a near infrared region . The state detection device has one or a plurality of light sources and a plurality of light receiving elements,
Based on the position of the light receiving element the reflected light or scattered light from the reflecting surface or the inclined surface of the implanted device is most strongly detected claims 1 and detects the operation setting status of the implanted device 4. The subcutaneous implanter unit according to any one of 3 above. Any of claims 1 to 3, characterized in that detecting the operation setting status of the implanted device by checking the direction of the reflected light reflected by the reflecting surface or the inclined surface of the implanted device visually The subcutaneous implanter unit described in 1.   The operation setting state of the subcutaneous implanter is detected based on the positional relationship between the position and orientation of the subcutaneous implanter itself and the emission position of light reflected by the reflective surface or inclined surface of the subcutaneous implanter. The subcutaneous implanter unit according to claim 5.   The subcutaneous implanter includes a valve body, a pressing member made of an elastic body provided in a state in which one end portion is in contact with the valve body and presses the valve body against the valve seat, and an operating pressure of the valve body The subcutaneous implanter unit according to any one of claims 1 to 6, wherein the subcutaneous implanter unit includes a pressure adjusting mechanism for adjusting the pressure. The pressure adjusting mechanism in the subcutaneously embedded valve device includes a rotating body having an inclined surface or a reflecting surface provided so as to abut against the pressing member, and a power transmission member that transmits power to the rotating body. The linear motion is converted into the rotational motion of the rotating body, and the operation of the valve body is adjusted by adjusting the pressing force of the pressing member against the valve body by the displacement of the contact position between the rotating body and the pressing member caused by the rotation of the rotating body. Has the function of adjusting the pressure,
By detecting the direction of reflected light or scattered light from the reflecting surface or inclined surface provided on the rotating body, the contact state between the rotating body and the pressing member is detected, thereby setting the operation of the subcutaneous implantable valve device The subcutaneous implanter unit according to claim 7, wherein the condition is detected.   The subcutaneous implanter unit according to any one of claims 1 to 6, wherein the subcutaneous implanter is a subcutaneous implantable valve device including a flow rate adjusting mechanism. The flow rate adjusting mechanism in the subcutaneous implantable valve device has a power transmission mechanism that converts a linear motion due to pressure or displacement applied from the outside through the skin into a rotational motion of the rotating body, and the displacement generated by the rotation of the rotating body , Having the function of adjusting the flow rate of the fluid by adjusting the size of the cross-sectional area of the flow path of the fluid introduced into the device,
By detecting the direction of the reflected or scattered light from the reflecting surface or inclined surface provided on the rotating body, the restricted state of the fluid flow in the flow path is detected, so that the operation setting state of the subcutaneous implantable valve device is determined. The subcutaneous implanter unit according to claim 9, wherein the subcutaneous implanter unit is detected.