JP6942687B2 - Medical device and medical device confirmation system - Google Patents

Description

The present invention relates to medical devices and medical devices confirmation system.

Conventionally, an implantable medical device in which a main body is embedded in the body has been used in order to inject a drug solution into the body. This medical device reduces the burden on patients who have to inject frequently to inject the drug solution. The medical device has a soft portion through which an injection needle is inserted in the main body portion. The soft portion is formed of, for example, silicone rubber or the like. Then, in the medical device, the chemical solution is injected into the chemical solution container through the soft portion. The drug solution is transported to the blood vessels through the catheter.

Since the main body of such a medical device is embedded in the body, it is difficult to visually identify the position of the soft part from the outside of the body.

Therefore, by applying the technique proposed in Patent Document 1, a luminescent material that emits near-infrared fluorescence when irradiated with near-infrared excitation light is mixed with a resin material to form a soft portion. Can be considered. With such a medical device, there is a possibility that the position of the soft portion can be visually specified by converting the near-infrared fluorescence into visible light.

Japanese Patent No. 5958922

However, when the light emitting material is mixed with the resin material to form a soft portion, the light emitting material is aggregated, and the amount of near-infrared fluorescence emitted by the light emitting material is reduced by concentration quenching, and as a result, the position of the soft portion is determined. It can be difficult to identify.

Although the medical device having a soft portion has been described here, the implantable medical device having no soft portion also has the same problem.

The present invention is, in view of the above circumstances, and an object thereof is to provide a medical device and medical device confirmation system for a predetermined position of the main body portion that is implanted in the body can be easily confirmed from the outside.

In order to achieve the above object, the medical device according to the present invention is a medical device in which the main body is embedded in the body and is used, and emits light having a wavelength that can be transmitted through the living body to at least a part of the main body. The light emitting material is characterized by containing a molding material contained in silica particles.

Further, the present invention is characterized in that, in the medical device, the molding material has particles in which the light emitting material is contained in a state of being dispersed in the silica particles.

Further, the present invention is characterized in that, in the medical device, the light emitting material is dispersed throughout from the center to the surface of the silica particles.

Further, the present invention is characterized in that, in the medical device, the light emitting material emits light having a wavelength different from the wavelength of the excitation light when irradiated with the excitation light.

Further, the present invention is characterized in that, in the medical device, the light emitting material is a phosphorescent material that stores and emits irradiated excitation light.

Further, the present invention is characterized in that, in the medical device, the periphery of the soft portion of the main body into which the injection needle for injecting a drug solution is inserted contains the molding material.

Further, the present invention is characterized in that, in the medical device, different portions are formed around the soft portion by a plurality of molding materials having different wavelengths of excitation light of the light emitting material.

Further, the medical device confirmation system according to the present invention is a system for confirming the position of the medical device, and is a light irradiation means for irradiating the main body of the medical device with excitation light from outside the body, and the light. It is characterized by including a light introducing means for introducing the light emitted by the light emitting material when the excitation light is irradiated by the irradiating means and making the portion including the molding material visible.

Further, according to the present invention, in the medical device confirmation system, the light introducing means acquires information including light emitted by the light emitting material by imaging from outside the body, converts the light into a visible wavelength, and converts the information into visible wavelengths. It is characterized in that it is displayed on the display unit.

Further, the present invention is characterized in that, in the medical device confirmation system, the light introducing means changes the light emitted by the light emitting material into visible light and emits it.

Further, the present invention is characterized in that, in the medical device confirmation system, the light introducing means is applied to the skin surface, and the light emitted by the light emitting material is changed to visible light and emitted.

Further, the medical device confirmation method according to the present invention is a method for confirming the position of the medical device, which includes a light irradiation step of irradiating the main body of the medical device with excitation light from outside the body and the light. It is characterized by including a light introduction step of introducing the light emitted by the light emitting material by the excitation light irradiated by the irradiation step and making the portion containing the molding material visible.

According to the medical device of the present invention, since the molding material contained in the main body has silica particles, the silica particles are well dispersed in the molding material, and the light emitting material is included in the silica particles. Therefore, the light emitting material does not aggregate in the molding material. Therefore, the light emitting material emits light having a predetermined wavelength with sufficient brightness. By passing through a filter or the like that converts the light into visible light, it is possible to easily confirm a predetermined portion of the main body embedded in the body from outside the body.

Further, according to the medical device confirmation system of the present invention, the light irradiating means irradiates the main body of the medical device with excitation light from outside the body, and the light introducing means irradiates the excitation light with the light irradiating means. Since the light emitted by the light emitting material is introduced to make the portion including the molding material visible, the effect is that a predetermined portion of the main body embedded in the body can be easily confirmed from outside the body.

Further, according to the medical device confirmation method of the present invention, the main body of the medical device is irradiated with excitation light from outside the body in the light irradiation step, and in the light introduction step, the light emitting material is generated by the excitation light irradiated by the light irradiation step. Since the emitted light is introduced to make the part containing the molding material visible, the effect is that the predetermined part of the main body embedded in the body can be easily confirmed from outside the body.

FIG. 1 is a configuration diagram schematically showing a medical device according to an embodiment of the present invention. FIG. 2 is a configuration diagram of the medical device shown in FIG. 1 as viewed from the outside of the body. FIG. 3 is an explanatory view showing the structure of a general silica glass. FIG. 4 is an explanatory diagram for explaining an example of a method of dispersing a light emitting material in silica particles. FIG. 5 is an explanatory diagram showing a state in which the light emitting portion shown in FIGS. 1 and 2 emits light. FIG. 6 is a configuration diagram of a modified example of the medical device shown in FIG. 1 as viewed from the outside of the body. FIG. 7-1 is an explanatory diagram showing a state in which the light emitting component of the light emitting unit shown in FIG. 6 emits light. FIG. 7-2 is an explanatory diagram showing a state in which the light emitting component of the light emitting unit shown in FIG. 6 emits light. FIG. 7-3 is an explanatory diagram showing a state in which the light emitting component of the light emitting unit shown in FIG. 6 emits light. FIG. 7-4 is an explanatory diagram showing a state in which the light emitting component of the light emitting unit shown in FIG. 6 emits light. FIG. 8 is a configuration diagram schematically showing a medical device confirmation system according to an embodiment of the present invention. FIG. 9 is a configuration diagram schematically showing a modified example of the medical device confirmation system according to the embodiment of the present invention. FIG. 10 is a configuration diagram schematically showing another modification of the medical device confirmation system according to the embodiment of the present invention.

With reference to the accompanying drawings, preferred embodiments of the medical device and the medical instrument check system according to the present invention will be described in detail.

<Medical equipment>
FIG. 1 is a configuration diagram schematically showing a medical device according to an embodiment of the present invention, and FIG. 2 is a configuration diagram of the medical device shown in FIG. 1 as viewed from the outside of the body. The medical device 10 illustrated here is, for example, a subcutaneous implantable port (CV port), and the main body 11 is embedded in the body 1.

The main body 11 is a housing made of, for example, an epoxy resin, and includes a chemical container 12, a soft portion 13, a catheter 14, and a light emitting portion 15. The chemical solution container 12 is a chamber for temporarily storing the chemical solution.

The soft portion 13 is a so-called septum, and closes the opening 12a on the outside of the body of the chemical solution container 12. The soft portion 13 is, for example, a soft lid made of silicone rubber, and is provided so as to be exposed from the main body portion 11. The soft portion 13 is a portion through which an injection needle 3 for injecting a drug solution is inserted from outside the body 2 after the main body portion 11 is embedded in the body 1.

One end of the catheter 14 communicates with the drug solution container 12, and the other end is inserted into a blood vessel or the like (not shown). The catheter 14 transports the drug solution temporarily stored in the drug solution container 12.

The light emitting portion 15 is formed in an annular shape on the outer end surface of the chemical solution container 12 and is provided around the soft portion 13. The light emitting unit 15 contains a molding material in which a general-purpose resin is mixed with particles contained in which a light emitting material is dispersed from the center to the surface of silica particles (silica nanoparticles). The light emitting portion 15 is formed by molding in a manner of being integrated with the main body portion 11. The light emitting unit 15 may contain a material other than the molding material described above.

The light emitting material emits light having a wavelength that can be transmitted through the living body when irradiated with light having a specific wavelength (excitation light). This wavelength is, for example, about 650 to 1000 nm. Here, as the light emitting material, "IR-820 (trade name; C ₄₆ H ₅₀ ClN _{2 NaO 6} S ₂ )", "IR-780 (trade name; C ₃₆ H ₄₄ ClIN ₂ )" and the like can be used. , It is dispersed in a state of being chemically bonded to silica particles. Such a light emitting material preferably has a concentration in the particles of, for example, 35 to 75 mmol / L.

Next, the dispersed state of the light emitting material in the silica particles will be described. The general silica glass 100 has a structure as shown in FIG. Reference numeral 101 in FIG. 3 indicates the particle surface of the silica glass 100.

In the silica glass 100, the light emitting material (fluorescent dye) is located at a position where metal ions such as aluminum (Al), boron (B), and sodium (Na) are contained, and is located in the SiO ₂ network (-O-Si-O-). It is dispersed on the way or by chemically bonding to the end of _{this SiO 2 network.}

As another example, in the silica glass 100, the light emitting material is −O— of the pentagonal ring shown by (a), the hexagonal ring shown by (b), and the hexagonal ring shown by (c) in FIG. It is dispersed by being confined in the ring of Si—O−.

Examples of the method of dispersing the light emitting material in the silica particles include the following (1) to (4).
(1) A light emitting material is added at the time of synthesizing silica particles. As a result, the _{light emitting material is incorporated into the SiO 2} network, and the light emitting material is uniformly dispersed from the center to the surface of the silica particles.
(2) After synthesizing silica particles, a light emitting material is added. As a result, the surface of the silica particles can be coated with a light emitting material and localized on the surface.
(3) After adding a light emitting material at the time of synthesizing silica particles as in (1), a silica layer is formed on the surface thereof. The light emitting material will be localized inside and on the surface of the silica particles.
(4) As shown in FIG. 4, a hollow shell 102 is formed of silica, and a light emitting material 103 is enclosed therein together with a solvent 104.

In such a medical device 10, since the molding material contained in the light emitting portion 15 contains silica particles, the silica particles are well dispersed in the molding material, and the light emitting material is from the center of the silica particles. Since it is contained in a state of being appropriately dispersed up to the surface, the light emitting material does not agglomerate in the molding material due to the presence of silica. Therefore, when the main body 11 is irradiated with excitation light having a specific wavelength from outside the body 2, light (fluorescence) having a wavelength different from the excitation light irradiated by the light emitting material is emitted. For example, the position of the annular light emitting portion 15 can be visually recognized from the outside of the body 2 as shown in FIG. 5 by passing through a filter or the like that converts the light into visible light.

Therefore, according to the medical device 10 according to the embodiment of the present invention, the position of the soft portion 13 in the portion surrounded by the light emitting portion 15 can be easily confirmed from the outside of the body 2.

According to the medical device 10, since the light emitting material has particles contained in a state of being dispersed throughout from the center to the surface of the silica particles, the light emitting portion 15 is directly dispersed in the main body portion 11 such as an epoxy resin. It is possible to prevent deterioration due to long-term use as compared with the case where the particles are used.

<Modification example of medical equipment>
Next, a modified example of the medical device 10 will be described. The light emitting unit 15 described above includes one molding material having particles in which the light emitting material is contained in a state of being dispersed throughout from the center to the surface of the silica particles, but the light emitting unit in the present invention is permeable to the living body. A light emitting material that emits light of a different wavelength may contain a molding material contained in silica particles, or may have the following configuration.

As shown in FIG. 6, the annular light emitting portion 15'is formed by connecting four light emitting constituents 15a, 15b, 15c, and 15d divided into four in the circumferential direction. Each light emitting component 15a, 15b, 15c, 15d contains a molding material having particles contained in a state in which the light emitting material is dispersed throughout from the center to the surface of the silica particles, and further, each light emitting component 15a , 15b, 15c, 15d may be different from each other so as to emit light having different wavelengths. For example, the light emitting unit 15'is composed of each light emitting component 15a, 15b, 15c, 15d including a molding material having different wavelengths of the excitation light to react and emitting light having different wavelengths.

In such a medical device 10', when the main body 11 is irradiated with excitation light having a specific wavelength from outside the body 2, any one of the four light emitting components 15a, 15b, 15c, and 15d, the light emitting component 15a, The light emitting materials of 15b, 15c, and 15d emit light having a wavelength different from the excitation light irradiated. For example, as shown in FIG. 7-1, only the light emitting component 15a can be visually recognized by passing through a filter or the like that converts the light into visible light. By irradiating with the wavelength of the excitation light changed in this way, as shown in FIGS. 7-2 to 7-4, the excitation light irradiated with the light emitting material of any of the light emitting components 15b, 15c, 15d. By emitting light having a wavelength different from that of the above, the light emitting components 15a, 15b, 15c, and 15d can be visually recognized through a filter or the like that converts the light into visible light.

Therefore, according to such a medical device 10', the position of the soft portion 13 in the vicinity of the light emitting portion 15'can be easily confirmed from the outside of the body 2.

Moreover, the injection needle 3 can be guided to be inserted into the soft portion 13 in the vicinity of the light emitting component portions 15a, 15b, 15c, and 15d that become visible, and the injection needle can be uniformly inserted over the entire area of the soft portion 13. 3 can be inserted. For example, at the time of the first insertion of the injection needle 3, only the light emitting component 15a is made to emit light, so that the injection needle 3 is inserted into the soft portion 13 in the vicinity of the light emitting component 15a. At the time of the second insertion of the injection needle 3, only the light emitting component 15b is made to emit light, so that the injection needle 3 is inserted into the soft portion 13 in the vicinity of the light emitting component 15b. At the time of the third insertion of the injection needle 3, only the light emitting component 15c is made to emit light, so that the injection needle 3 is inserted into the soft portion 13 in the vicinity of the light emitting component 15c. At the time of the fourth insertion of the injection needle 3, only the light emitting component 15d is made to emit light, so that the injection needle 3 is inserted into the soft portion 13 in the vicinity of the light emitting component 15d. As a result, it is possible to prevent the injection needle 3 from being continuously inserted into, for example, the central portion of the soft portion 13 many times in succession, and it is possible to prevent the soft portion 13 from being damaged at an early stage. Therefore, the service life of the soft portion 13 can be extended.

In the examples of FIGS. 6 to 7-4, the light emitting materials emit light having different wavelengths, but in the present invention, the amount of light emitted by the light emitting materials of each light emitting component is different from each other. May be good.

The light emitting portion 15 described above was formed in an annular shape around the end surface of the chemical solution container 12 on the outside of the body, that is, around the soft portion 13, but the light emitting portion of the present invention is formed on the outside of the body of the main body. Alternatively, the particles contained in a state in which the light emitting material is dispersed from the center to the surface of the silica particles are mixed with the epoxy resin constituting the main body to be formed at a predetermined position on the main body. May be good.

The light emitting material constituting the light emitting unit 15 described above emits light (fluorescence) having a wavelength (for example, 650 to 1000 nm) that can be transmitted through the living body when irradiated with excitation light having a specific wavelength. In the present invention, the light emitting material may store the irradiated light and emit light having a wavelength (for example, 650 to 1000 nm) that can be transmitted through the living body.

According to this, even if the excitation light is not continuously irradiated, the light emitting material emits phosphorescence, so that a predetermined portion (for example, a soft portion) of the main body portion can be easily confirmed from outside the body.

The light emitting portion 15 and the light emitting portion 15'described above were formed in an annular shape on the end face on the outer side of the body of the chemical solution container 12, but in the present invention, the light emitting portion may form a soft portion. That is, the soft portion may contain a molding material constituting the light emitting portion. Even with such a configuration, the position of the soft portion can be easily confirmed from outside the body by emitting fluorescence or the like from the light emitting material constituting the soft portion.

<Medical device confirmation system and medical device confirmation method>
FIG. 8 is a configuration diagram schematically showing a medical device confirmation system according to an embodiment of the present invention. The medical device confirmation system 20 illustrated here is for confirming the position of the soft portion 13 of the medical device 10 shown in FIG. 1 embedded in the body 1 (particularly, the position where the injection needle 3 is inserted). In addition to the medical device 10, a light source (light irradiation means) 30 and a light introduction unit (light introduction means) 40 are provided. Since the configuration of the medical device 10 has been described above, the description thereof will be omitted below.

The light source 30 is composed of, for example, an incandescent light bulb or the like, and is arranged outside the body 2 to irradiate excitation light having a specific wavelength. The light introduction unit 40 includes an imaging unit 40a, a display unit 40b, and a control unit 40c.

The image pickup unit 40a is composed of, for example, a camera or the like. The imaging unit 40a images the body surface portion irradiated with the light source 30 and generates image information of the body surface portion, that is, image information including fluorescence emitted from the main body portion 11 of the medical device 10. The image pickup unit 40a transmits the generated image information to the control unit 40c.

The display unit 40b displays various types of information, and particularly displays information based on a command transmitted from the control unit 40c. The control unit 40c is electrically connected to the above-mentioned imaging unit 40a and display unit 40b, and controls the operation of each of these units according to the programs and data stored in the similarly electrically connected storage unit (not shown). It is to control the purpose. The control unit 40c may be realized by, for example, a processing device such as a CPU (Central Processing Unit) executing a program, that is, by software, or by hardware such as an IC (Integrated Circuit). Alternatively, it may be realized by using software and hardware together.

The control unit 40c acquires image information read and generated through the image pickup unit 40a, and displays the image information obtained by converting the light contained in the image information into light having a visible wavelength on the display unit 40b. Is.

In the medical device confirmation system 20, the light source 30 irradiates excitation light of a specific wavelength from outside the body 2 (light irradiation step). Then, the light emitting material is emitted by displaying the image information read and generated by the imaging unit 40a on the display unit 40b as image information obtained by converting the light contained in the image information into light having a visible wavelength. Light (fluorescence) is introduced to make the light emitting portion 15 (the portion including the molding material) visible (light introduction step).

Therefore, according to the medical device confirmation system 20 according to the embodiment of the present invention, the position of the soft portion 13 in the portion surrounded by the light emitting portion 15 can be easily confirmed from the outside of the body 2.

<Modified example of medical device confirmation system>
Next, a modified example of the medical device confirmation system 20 will be described. The optical introduction unit 40 of the medical device confirmation system 20 described above may be composed of a mobile terminal device such as a smartphone or a tablet terminal. In such a mobile terminal device, the patient himself / herself in which the medical device 10 is embedded in the body 1 by setting the so-called self-shooting mode in which the display unit 40b and the imaging unit 40a (in-camera) are on the same surface. Therefore, the position of the soft portion 13 can be easily confirmed, and the patient can insert the injection needle 3 into the soft portion 13 by himself / herself.

The above-mentioned light introduction unit 40 has been described as an example of the light introduction means, but the light introduction means in the present invention introduces the light emitted by the light emitting material when the light irradiation means is irradiated, and the soft portion containing the molding material. Various forms can be adopted as long as the surroundings can be made visible.

Therefore, in the present invention, as shown in FIG. 9, the filter 41 can be used instead of the light introduction unit 40. The filter 41 introduces the light emitted by the light emitting material, changes it to visible light, and emits it. Even in the medical device confirmation system 21 using such a filter 41, the position of the soft portion 13 in the portion surrounded by the light emitting portion 15 can be easily confirmed from the outside of the body 2, and the soft portion 13 is injected. The needle 3 can be inserted.

In particular, if the filter 41 is used for a lens such as eyeglasses, a user such as a medical worker does not need to hold the filter 41 by hand, and can confirm the position of the soft portion 13 simply by wearing the eyeglasses, and the soft portion 13 can be confirmed. The injection needle 3 can be inserted into the lens to easily inject the drug solution.

The above-mentioned light introduction unit 40 includes an imaging unit 40a and a display unit 40b, but in the present invention, as shown in FIG. 10, a sheet 42 can be used instead of the light introduction unit 40. The sheet 42 is formed by being applied to the skin surface 1a, and is formed by introducing the light emitted by the light emitting material, changing the light into visible light, and emitting the light. Even in the medical device confirmation system 22 using such a sheet 42, the position of the soft portion 13 in the portion surrounded by the light emitting portion 15 can be easily confirmed from the outside of the body 2, and the soft portion 13 is injected. The needle 3 can be inserted.

10 Medical device 11 Main body 12 Chemical container 13 Soft part 14 Catheter 15 Light emitting part 20 Medical device confirmation system 30 Light source (light irradiation means)
40 Light introduction unit (light introduction means)
40a Imaging unit 40b Display unit 40c Control unit

Claims (9)

It is a medical device whose main body is embedded in the body and used.
The main body portion has a light emitting portion including a molding material in which a light emitting material emitting light having a wavelength that can be transmitted through a living body is included in silica particles around a soft portion through which an injection needle for injecting a chemical solution is inserted.
The light emitting portion is formed by connecting a plurality of light emitting components in the circumferential direction.
A medical device, wherein the plurality of light emitting components include molding materials having different wavelengths of excitation light of the light emitting material each of the light emitting components so as to emit light having different wavelengths. The medical device according to claim 1, wherein the molding material has particles in which the light emitting material is contained in a state of being dispersed in the silica particles. The medical device according to claim 2, wherein the light emitting material is dispersed throughout from the center to the surface of the silica particles. The medical device according to any one of claims 1 to 3, wherein the light emitting material emits light having a wavelength different from the wavelength of the excitation light when irradiated with the excitation light. The medical device according to claim 1 or 2, wherein the light emitting material is a phosphorescent material that stores and emits irradiated excitation light. A system for confirming the position of the medical device according to any one of claims 1 to 5.
A light irradiation means for irradiating the main body of the medical device with excitation light from outside the body,
A medical device confirmation system including a light introducing means that introduces light emitted by the light emitting material when excitation light is irradiated by the light irradiating means and makes a portion including the molding material visible. .. The claim is characterized in that the light introducing means acquires information including light emitted by the light emitting material by taking an image from outside the body, converts the light into a visible wavelength, and displays the information on a display unit. The medical device confirmation system according to 6. The medical device confirmation system according to claim 6, wherein the light introducing means changes the light emitted by the light emitting material into visible light and emits it. The medical device confirmation system according to claim 6, wherein the light introducing means is applied to a skin surface, and the light emitted by the light emitting material is changed to visible light and emitted.

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