Medical instrument

Abstract

Provided is a medical instrument according to which, even when an optical fiber is inserted into a catheter, it is possible to secure enough space inside the catheter .　A medical instrument 1 includes: a catheter 10 to be inserted into a living body; and an optical fiber 20 which is inserted into the catheter 10 and emits light for indicating a tip part of the catheter 10. The optical fiber 20 is made of quartz glass and has an outer diameter dimension D of 200 μm or less.

Description

medical equipment

[0001] The present invention relates to a medical device that, for example, when a catheter is inserted into a living body, makes it possible to visually confirm the position of the tip of the catheter inside the living body from outside the living body.

[0002] A known conventional medical instrument includes a catheter that is inserted into a living body and an optical fiber that is inserted into the catheter and emits light to indicate the tip of the catheter (see, for example, Patent Document 1).

[0003] Japanese Patent Application Laid-Open No. 2022-81579

[0004] In conventional medical instruments, the optical fiber is made of synthetic resin, so the optical fiber occupies a large proportion of the space inside the catheter, making it difficult to inject medicine or insert other instruments into the catheter with the optical fiber inserted.For this reason, in conventional medical instruments, the catheter with the optical fiber inserted is inserted into a living body, the position of the tip of the catheter within the living body is confirmed by light emitted from the optical fiber, and then the optical fiber is removed from the catheter, and a medicine is injected into the catheter or an instrument is inserted into the catheter to treat the affected area of ​​the living body.

[0005] Furthermore, there is a demand for medical devices with smaller outer diameter catheters, but optical fibers made of synthetic resin have low rigidity, making it difficult to insert the optical fiber into the catheter.

[0006] The object of the present invention is to provide a medical device that allows an optical fiber to be easily inserted into a catheter and that ensures the necessary space inside the catheter even when the optical fiber is inserted inside the catheter.

[0007] The medical device according to the present invention comprises a catheter to be inserted into a living body, and an optical fiber that is inserted into the catheter and emits light to indicate the position of the tip of the catheter, wherein the optical fiber has a core made of quartz glass and an outer diameter dimension of 200 μm or less.

[0008] In the medical device according to the present invention, the optical fiber preferably has an outer diameter of 80 μm or more and 200 μm or less.

[0009] In the medical device according to the present invention, the optical fiber preferably has a cladding made of resin.

[0010] In the medical device according to the present invention, it is preferable that the optical fiber is fixed to the catheter by an adhesive.

[0011] In the medical device according to the present invention, the catheter preferably has a first inlet through which the optical fiber is introduced and a second inlet through which another object is introduced.

[0012] Furthermore, the medical instrument according to the present invention preferably includes a laser device that outputs laser light as the light emitted from the tip end of the optical fiber.

[0013] According to the present invention, the space occupied by the optical fiber 20 inside the catheter 10 is reduced, so that the necessary space can be secured even when the optical fiber 20 is placed inside the catheter 10, and treatment of the affected area can be performed without the need to remove the optical fiber 20, thereby improving the efficiency of the treatment procedure.

[0014] Fig. 1 is a schematic view of a medical device according to a first embodiment of the present invention. Fig. 2 is a transverse cross-sectional view of the medical device according to the first embodiment of the present invention. Fig. 3 is a schematic view of the proximal end side of a catheter according to the first embodiment of the present invention. Fig. 4 is a transverse cross-sectional view of a medical device according to a second embodiment of the present invention. Fig. 5 is a schematic view of the proximal end side of a catheter according to the second embodiment of the present invention.

[0015] 1 to 3 show a first embodiment of the present invention. Fig. 1 is a schematic diagram of a medical device, Fig. 2 is a cross-sectional view of the medical device, and Fig. 3 is a schematic diagram of the proximal end side of a catheter.

[0016] The medical device 1 of this embodiment is used to treat an affected area by reaching the distal end thereof to the affected area in a living body.

[0017] As shown in Figure 1, this medical instrument 1 comprises a catheter 10 to be inserted into a living body, an optical fiber 20 inserted into the catheter 10 and emitting light to indicate the position of the tip of the catheter 10, and a laser device 30 for generating laser light to be transmitted by the optical fiber 20.

[0018] The catheter 10 is a tubular member made of a flexible synthetic resin such as polyvinyl chloride or silicone rubber. As shown in Figures 1 and 2, the catheter 10 has a first conduit 11 through which an optical fiber 20 is inserted, and a second conduit 12 through which a treatment instrument 2 for directly treating an affected area is inserted as another member. As shown in Figure 3, the first conduit 11 and the second conduit 12 are separated at the proximal end of the catheter 10, and the first conduit 11 extends obliquely relative to the direction in which the second conduit 12 extends. The catheter 10 has an outer diameter of, for example, 0.5 mm to 10 mm, and the first conduit 11 and the second conduit 12 each have an inner diameter of 0.3 mm to 10 mm.

[0019] 1 and 3, a first inlet 11a is provided at the base end on the first conduit 11 side, through which the optical fiber 20 is inserted. As shown in FIG. 3, a connector 11b formed integrally with the optical fiber 20 is attached to the first inlet 11a.

[0020] 1 and 3, a second inlet 12a through which the treatment instrument 2 is inserted is provided at the base end on the second conduit 12 side. As shown in Fig. 3, a lid 12b is attached to the second inlet 12a when the treatment instrument 2 is not inserted.

[0021] The optical fiber 20 has a core 21 located at the center and a clad 22 surrounding the outer periphery of the core 21. The core 21 and the clad 22 are each made of silica glass. The optical fiber 20 has an outer diameter D of 200 μm or less.

[0022] Furthermore, it is preferable that the optical fiber 20 has an outer diameter D of 80 μm or more and 200 μm or less. If the outer diameter D of the optical fiber 20 is smaller than 80 μm, breakage such as bending may easily occur, which may make stable production difficult.

[0023] The optical fiber 20 may be coated with a polyimide coating of 10 μm or less. Alternatively, the optical fiber 20 may have a core 21 formed from silica glass and a cladding 22 formed from a resin material such as a fluororesin or silicone resin. If the core of the optical fiber is formed from a material other than silica glass and the cladding is formed from a resin material, and the outer diameter is set to 200 μm or less, the optical fiber loses tension, making it difficult to insert into the first conduit 11 of the catheter 10. Furthermore, if the core of the optical fiber is formed from a material other than silica glass and the cladding is formed from fluoride glass, the optical fiber becomes brittle and easily breaks, making it undesirable for this application.

[0024] The optical fiber 20 is inserted into the first conduit 11 from the first inlet 11a of the catheter 10, and its tip is located at the tip of the catheter 10. As shown in Figure 2, the optical fiber 20 is fixed to the inner wall of the first conduit 11 with an adhesive 40.

[0025] Here, it is sufficient that at least the tip portion of the optical fiber 20 is fixed to the first conduit 11 of the catheter 10 with the adhesive 40. The optical fiber 20 may be fixed over the entire length of the catheter 10, or may be fixed at multiple locations spaced at predetermined intervals along the longitudinal direction of the catheter, or may be fixed at the tip portion, the base end portion, and an intermediate portion along the longitudinal direction.

[0026] The laser device 30 amplifies light in an oscillator tube and outputs laser light.

[0027] When treating an affected area of ​​a living body using the medical device 1 configured as described above, the catheter 10 is inserted into the living body from the tip side, the tip of the catheter 10 is reached to the affected area of ​​the living body, and the treatment device 2 is reached to the affected area via the second duct 12 of the catheter 10.

[0028] When the tip of the catheter 10 is to reach the affected area inside the living body, laser light generated by the laser device 30 is emitted from the tip of the optical fiber 20, and the laser light emitted from the tip of the optical fiber 20 is visually confirmed from outside the living body to determine whether the tip of the catheter 10 is located at the affected area.

[0029] Thus, the medical device of this embodiment is a medical device 1 comprising a catheter 10 to be inserted into a living body, and an optical fiber 20 that is inserted into the catheter 10 and emits light to indicate the tip of the catheter 10, wherein the optical fiber 20 has a core 21 made of quartz glass and an outer diameter dimension D of 200 μm or less.

[0030] This reduces the space occupied by the optical fiber 20 inside the catheter 10, making it possible to secure the necessary space even when the optical fiber 20 is placed inside the catheter 10, and it becomes possible to treat the affected area without having to remove the optical fiber 20, thereby improving the efficiency of the treatment procedure.

[0031] Moreover, the optical fiber 20 preferably has a cladding 22 made of resin.

[0032] As a result, the core 21 made of quartz glass is covered with the cladding 22 made of resin, making it possible to prevent damage to the core 21.

[0033] Preferably, the optical fiber 20 is fixed to the catheter 10 by adhesive 40 .

[0034] This prevents the optical fiber 20 from being misaligned relative to the catheter 10, making it possible to reliably notify the position of the tip of the catheter 10.

[0035] The catheter 10 preferably has a first inlet 11a through which the optical fiber 20 is inserted and a second inlet 12a through which the treatment instrument 2 as another object is inserted.

[0036] This makes it possible to insert the treatment instrument 2 through the second inlet 12a, which is configured separately from the first inlet 11a through which the optical fiber 20 is inserted, making it easier to handle the treatment instrument 2 and further improving the efficiency of the treatment procedure.

[0037] It is also preferable to include a laser device 30 that outputs laser light as light emitted from the tip of the optical fiber 20.

[0038] This makes it possible to easily visualize the laser light from outside the living body by using highly directional and convergent laser light, and thus makes it possible to easily identify the position of the tip of the catheter from outside the living body.

[0039] <Second embodiment> Figures 4 and 5 show a second embodiment of the present invention. Figure 4 is a cross-sectional view of the medical device, and Figure 5 is a schematic view of the base end side of the catheter. Note that components similar to those in the previous embodiment are designated by the same reference numerals.

[0040] 4 and 5 , the catheter 50 of the medical device 1 of this embodiment is provided in a portion other than the base end side and has a conduit 51 through which the optical fiber 20 and the treatment device 2 are inserted. Furthermore, as shown in Fig. 5 , the base end side of the catheter 50 is separated into a first base end conduit 51a through which the optical fiber 20 is inserted and a second base end conduit 51b through which the treatment device 2 is inserted, with the first base end conduit 51a extending obliquely with respect to the direction in which the second base end conduit 51b extends. For example, the catheter 50 is formed to have an outer diameter of 0.5 mm or more and 10 mm or less, and the conduit 51 is formed to have an inner diameter of 0.3 mm or more and 10 mm or less.

[0041] The end of the first proximal conduit 51a is provided with a first inlet 51a1 through which the optical fiber 20 is inserted. A connector 51a2 formed integrally with the optical fiber 20 is attached to the first inlet 51a1.

[0042] Further, a second inlet 51b1 is provided at the end of the second proximal conduit 51b, through which the treatment instrument 2 is inserted. A lid 51b2 is attached to the second inlet 51b1 when the treatment instrument 2 is not inserted.

[0043] The optical fiber 20 is inserted from the first inlet 51 a 1 of the catheter 50 through the first proximal conduit 51 a and the conduit 51 , and its tip is located at the tip of the catheter 50 .

[0044] As shown in Fig. 4, the optical fiber 20 is fixed to the inner wall of the conduit 51 by an adhesive 40. As shown in Fig. 4, the optical fiber 20 is fixed to the inner wall of the conduit 51 by the adhesive 40 applied within a range of about one-third of the outer circumferential surface. The optical fiber 20 may be fixed to the inner wall of the conduit 51 by the adhesive 40 applied over about half of the outer circumferential surface or over the entire outer circumferential surface in order to prevent the optical fiber 20 from being detached from the conduit 51 in parts of the conduit 51 that are prone to bending or parts where tensile force is likely to act.

[0045] In the medical device 1 configured as described above, the optical fiber 20 is inserted into the duct 51 through the first inlet 51a1 of the catheter 50, and the treatment device 2 is inserted into the duct 51 through the second inlet 51b1. The treatment device 2 is inserted into the duct 51 with the optical fiber 20 inserted therein.

[0046] Thus, according to the medical device of this embodiment, as in the first embodiment, the space occupied by the optical fiber 20 inside the catheter 50 is reduced, so that even when the optical fiber 20 is placed inside the catheter 50, the necessary space can be secured, and it becomes possible to treat the affected area without having to remove the optical fiber 20, thereby improving the efficiency of the treatment procedure.

[0047] In the above embodiment, the treatment instrument 2 for directly treating the affected area is inserted into the second conduit 12, but the present invention is not limited to this. The second conduit 12 may be configured to pass a liquid such as a medicine to be supplied to the affected area.

[0048] Furthermore, in the above-described embodiment, the optical fiber 20 is fixed to the catheter 10, 50 by the adhesive 40, but this is not limiting. If the optical fiber can be fixed to the catheter, the optical fiber may be fixed to the catheter by engaging the optical fiber with the inner wall of the catheter, for example, by forming a female thread on the inner wall of the catheter and forming a male thread on the outer periphery of the optical fiber, and screwing the optical fiber onto the inner wall of the catheter, without using an adhesive.

[0049] The present invention will be specifically explained below with reference to examples, but the present invention is not limited to these examples.

[0050] An optical fiber insertion test was conducted in which several types of optical fibers 20 with different materials and outer diameters were inserted into the first conduit 11 of the catheter 10 of Figure 2, and the results are shown in Examples 1 to 5 and Comparative Examples 1 and 2 in Table 1.

[0051] Furthermore, an optical fiber insertion test was conducted on the catheter 50 of FIG. 4, in which each of several types of optical fibers 20 having different materials and outer diameters was inserted into the conduit 51, and a drug solution flow test was conducted in which a drug solution was flowed through the conduit 51. The results are shown in Table 1 for Examples 6 to 9 and Comparative Examples 3 to 5.

[0052] The optical fiber insertion test was performed using a catheter 10, 50 with a total length of 1 m and whose duct had been cleaned, a cleaned optical fiber 20, and a quartz dummy fiber with an outer diameter of 0.2 mm. In the optical fiber insertion test, the quartz dummy fiber was inserted into the catheter 10, 50, the optical fiber 20 was connected to the quartz dummy fiber inserted into the catheter 10, 50, the quartz dummy fiber was wound at a speed of 20 mm / s, and the optical fiber 20 was inserted into the catheter 10, 50. In the optical fiber insertion test, if the optical fiber 20 could be inserted over the entire length of the catheter 10, 50, the optical fiber insertability was determined to be good ("◯" in Table 1), and if the optical fiber 20 could not be inserted over the entire length of the catheter 10, 50, the optical fiber insertability was determined to be poor ("X" in Table 1).

[0053] The drug solution flow test was conducted using a catheter 50 with a total length of 1 m, the inside of which had been cleaned, and an infusion bag containing the drug solution. In the drug solution flow test, the catheter 50, with an infusion bag connected to its upper end, was held in a hanging position, and the drug solution was allowed to flow from the infusion bag into the catheter's infusion line 51 at a rate of approximately 2 mL / kg / hour. In the drug solution flow test, if the drug solution could be circulated through the catheter 50 at a rate of approximately 2 mL / kg / hour, the drug solution fluidity was judged to be good ("◯" in Table 1), and if the drug solution could not be circulated at a rate of approximately 2 mL / kg / hour, the drug solution fluidity was judged to be poor ("X" in Table 1).

[0054] In Examples 1 to 5 and Comparative Examples 1 and 2, when the optical fiber insertion property was judged to be good, the overall judgment was judged to be good. In addition, in Examples 6 to 9 and Comparative Examples 3 to 6, when both the optical fiber insertion property and the liquid medicine fluidity were judged to be good, the overall judgment was judged to be good.

[0055] Example 1 Example 1 uses the catheter 10 shown in FIG. 2, which has an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and the optical fiber 20, which is made of quartz and has an outer diameter of 0.25 mm.

[0056] Example 2 Example 2 uses the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.20 mm.

[0057] Example 3 Example 3 uses the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.12 mm.

[0058] Example 4 Example 4 uses the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.10 mm.

[0059] Example 5 Example 5 uses the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.08 mm.

[0060] Comparative Example 1 Comparative Example 1 is the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and an optical fiber made of resin having an outer diameter of 0.25 mm.

[0061] Comparative Example 2 Comparative Example 2 is the catheter 10 of FIG. 2 having an outer diameter of 0.5 mm and an inner diameter of the first conduit 11 of 0.3 mm, and an optical fiber made of resin having an outer diameter of 0.20 mm.

[0062] Comparative Example 3 Comparative Example 3 is the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and an optical fiber made of quartz having an outer diameter of 0.25 mm.

[0063] Example 6 Example 6 uses the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.20 mm.

[0064] Example 7 Example 7 uses the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.12 mm.

[0065] Example 8 Example 8 uses the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.10 mm.

[0066] Example 9 Example 9 uses the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and the optical fiber 20 made of quartz and having an outer diameter of 0.08 mm.

[0067] Comparative Example 4 Comparative Example 4 is the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and an optical fiber made of resin having an outer diameter of 0.25 mm.

[0068] Comparative Example 5 Comparative Example 5 is the catheter 10 of FIG. 4 having an outer diameter of 0.5 mm and an inner diameter of the conduit 51 of 0.3 mm, and an optical fiber made of resin having an outer diameter of 0.20 mm.

[0069]

[0070] As shown in Table 1, it was confirmed that the insertion ability of the optical fiber was poor in the catheter 10 of Fig. 2 in Comparative Examples 1 and 2. In Comparative Examples 1 and 2, the optical fiber was made of resin, which is thought to be due to its low rigidity.

[0071] On the other hand, in Examples 1 to 5, it was confirmed that the catheter 10 shown in Fig. 2 had good optical fiber insertion properties. In Examples 1 to 5, the optical fiber was made of quartz, which has higher rigidity than resin, which is thought to be the reason for the high optical fiber insertion properties.

[0072] In Comparative Example 3, it was confirmed that the catheter 50 shown in Fig. 4 had good optical fiber insertion properties but poor medicinal fluidity. In Comparative Example 3, the optical fiber was made of quartz, which has high rigidity, but the outer diameter was large, which is thought to be the reason for the poor medicinal fluidity.

[0073] In Comparative Example 4, it was confirmed that the catheter 50 shown in Fig. 4 had poor optical fiber insertion properties and poor drug solution fluidity. In Comparative Example 4, the optical fiber was made of resin, which reduced rigidity, and the large outer diameter was thought to result in poor drug solution fluidity.

[0074] In Comparative Example 5, it was confirmed that the fluidity of the drug solution was good but the insertion ability of the optical fiber was poor in the catheter 50 of Fig. 4. In Comparative Example 5, the fluidity of the drug solution was high because the outer diameter was small, but the rigidity was low because the optical fiber was made of resin.

[0075] On the other hand, in Examples 6 to 9, it was confirmed that the catheter 50 shown in Figure 4 had good optical fiber insertion properties and good medicinal fluidity. In Examples 6 to 9, the optical fiber was made of quartz, which has high rigidity, and the optical fiber insertion properties were good, and the outer diameter was small, which is thought to be why the medicinal fluidity was high.

[0076] REFERENCE SIGNS LIST 1 Medical device 2 Treatment device 10, 50 Catheter 11a, 51a1 First inlet 12a, 51b1 Second inlet 20 Optical fiber 21 Core 22 Cladding 30 Laser device 40 Adhesive D Outer diameter dimension

Claims

1. A medical device comprising a catheter to be inserted into a living body, and an optical fiber that is inserted into the catheter and emits light to indicate the position of the tip of the catheter, wherein the optical fiber has a core made of silica glass and an outer diameter of 200 μm or less.

2. The medical device according to claim 1, wherein the optical fiber has an outer diameter of 80 μm or more and 200 μm or less.

3. The medical device according to claim 1, wherein the optical fiber has a cladding made of resin.

4. The medical device according to any one of claims 1 to 3, wherein the optical fiber is fixed to the catheter by an adhesive.

5. The medical device according to claim 1, wherein the catheter has a first inlet through which the optical fiber is introduced and a second inlet through which other objects are introduced.

6. The medical device according to claim 1, further comprising a laser device that outputs laser light as the light emitted from the tip of the optical fiber.

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