Vascular puncture device and vascular puncture system

Abstract

The invention relates to a vascular puncture device (10) and a vascular puncture system (12). A blood vessel puncture device (10) of a blood vessel puncture system (12) is provided with a needle body (36), a hub (38), and a light source unit (20). The tip of the needle body has a blade surface (42) and a tip opening (44). A light guide member (22) for guiding light emitted by a light source unit toward a tip opening is disposed in a lumen (40) of a needle body, the light guide member has a light guide tip section (82) protruding in the tip direction from a base end (80) of the tip opening, and the outer surface of the light guide tip section has: a light release section (88) for releasing light (L1) in the direction in which the tip opening faces; and a light-tight part (78) that prevents the release of light.

Description

Technical Field

[0001] The invention relates to a blood vessel puncture device and a blood vessel puncture system. Background Art

[0002] For example, Japanese Patent Publication No. 2018-171231 discloses a blood vessel puncture device comprising: a needle body capable of puncturing a blood vessel in a living body; a needle hub disposed at the base end of the needle body; a light source unit disposed at the needle hub; and a light guide component that guides light emitted by the light source unit toward the front end of the needle body. The needle body is provided with: a first inner cavity through which a guide wire can be inserted, and a second inner cavity in which the light guide component is disposed. The front end of the needle body is provided with: a blade surface forming a front end opening communicating with the first inner cavity; and an exposure hole for communicating with the second inner cavity to expose the front end of the light guide component. The exposure hole is located closer to the base end than the front end opening.

[0003] With this vascular puncture device, since the light guided from the light guide member through the exposure hole is absorbed or attenuated by the blood, the intensity of the light received or visually detected outside the living body part changes before and after the exposure hole formed at the distal end of the needle body is inserted into the blood vessel. Therefore, the insertion of the distal end of the needle body into the blood vessel can be detected based on the light emitted by the light source unit.

[0004] However, in the above-mentioned blood vessel puncturing device, since the exposure hole is located closer to the proximal end than the distal end opening of the needle body, it may not be possible to quickly detect that the distal end opening has been inserted into the blood vessel. Summary of the Invention

[0005] An object of the present invention is to solve the above-mentioned problems.

[0006] (1) A first embodiment of the present invention is a blood vessel puncture device comprising: a tubular needle body capable of puncturing a blood vessel in a living body; a needle seat provided at the base end of the needle body; and a light source unit provided at the needle seat, wherein the front end of the needle body comprises: a blade surface; and a front end opening formed on the blade surface and connected to the inner cavity of the needle body, wherein a light guide component for guiding light emitted by the light source unit toward the front end opening is provided in the inner cavity of the needle body, the light guide component having a light guide front end protruding toward the front end direction from the base end of the front end opening, and an outer surface of the light guide front end comprising: a light release portion for releasing the light in the direction toward which the front end opening is facing; and a light-proof portion for preventing the release of the light.

[0007] According to this structure, the light emitted by the light source unit is released from the light-releasing portion of the light guide front end through the front end opening. Therefore, it is possible to quickly determine that the front end opening of the needle body has been inserted into the blood vessel. In addition, since the outer surface of the light guide front end has an opaque portion, the amount of light released from the light guide front end can be suppressed. As a result, diffuse reflection within the skin tissue is suppressed, and the luminous area of the light guide front end becomes narrower, so that the position of the front end opening of the needle body within the skin tissue can be determined more accurately. Therefore, the needle body can be punctured into the blood vessel with high precision.

[0008] (2) In the blood vessel puncture device described in the above item (1), the light-impermeable portion may be provided on the front end surface of the light guide front end portion.

[0009] This structure can reduce the amount of light emitted toward the tip of the needle, thereby narrowing the light-emitting area of the light-guiding tip within the skin tissue.

[0010] (3) In the blood vessel puncture device described in the above item (2), the light-impermeable portion may be provided on the entire front end surface of the light guide front end portion.

[0011] According to such a configuration, diffuse reflection in the skin tissue can be further suppressed.

[0012] (4) In the blood vessel puncture device according to any one of the above items (1) to (3), the light emitting portion and the light-impermeable portion may be provided on an outer peripheral surface of the light guide tip portion.

[0013] According to such a configuration, since it is possible to suppress the emission of unnecessary light from the outer peripheral surface of the light guide tip portion, it is possible to further suppress diffuse reflection in the skin tissue.

[0014] (5) In the blood vessel puncturing device according to any one of the above items (1) to (4), the light emitting portion may extend along the axial direction of the light guide member.

[0015] (6) In the blood vessel puncturing device according to any one of the above items (1) to (4), a plurality of light emitting portions may be arranged at intervals along the axial direction of the light guide member.

[0016] According to this structure, when the distal end opening of the needle body is inserted into the blood vessel, the light emitting portion gradually becomes invisible from the distal end direction, thereby making it easier for the user to understand how far the distal end opening of the needle body has been inserted into the blood vessel.

[0017] (7) In the blood vessel puncture device according to any one of the above items (1) to (4), the light emitting portion may extend in a ring shape along the circumference of the light guide distal end portion.

[0018] According to such a configuration, it is unnecessary to position the light releasing portion and the front end opening in the circumferential direction of the light guide front end portion.

[0019] (8) The blood vessel puncture device described in the above item (4) may be configured such that the length of the light releasing portion along the circumference of the light guide distal end portion is less than half the circumference of the light guide distal end portion.

[0020] According to such a configuration, diffuse reflection in the skin tissue can be effectively suppressed.

[0021] (9) In the blood vessel puncture device according to any one of the above items (1) to (8), the light source unit may emit near-infrared light.

[0022] According to such a configuration, near-infrared light can more easily penetrate skin tissue and be absorbed by hemoglobin than visible light, and therefore it can be more easily detected that the distal end opening has been inserted into the blood vessel.

[0023] (10) In the blood vessel puncture device according to any one of the above items (1) to (9), the light source unit may be detachable from the needle holder.

[0024] According to this structure, whether or not to emit light at the light guide tip can be selected according to the position of the blood vessel to be punctured and the puncture technique of the user.

[0025] (11) Based on the blood vessel puncture device described in the above item (10), it can also be constructed as follows: the light guide component is arranged on the light source unit, and the inner surface of the needle seat has a guide surface that is tapered toward the inner cavity of the needle body.

[0026] According to such a configuration, when the light source unit is mounted on the needle hub, the light guide member can be easily inserted into the inner cavity of the needle body via the guide surface.

[0027] (12) Based on the blood vessel puncture device described in any one of the above items (1) to (11), it can also be constructed as follows: a blood introduction path for guiding blood to the needle seat is provided in the needle body or the light guiding component, and a blood inflow portion for confirming the flash back of the blood guided from the blood introduction path is provided on the needle seat.

[0028] According to such a configuration, it is possible to confirm again that the distal end opening has been inserted into the blood vessel by the inflow of blood into the blood inlet portion.

[0029] (13) The blood vessel puncture device described in item (12) may be configured such that a blood flow blocking portion is provided on the needle seat to block the blood flowing into the blood inflow portion from flowing toward the light source unit.

[0030] According to such a structure, the blood circulation blocking portion can prevent the light source unit from coming into contact with blood. Therefore, when the light source unit is detachable from the needle hub, the light source unit can be reused.

[0031] (14) Based on the vascular puncture device described in any one of the above items (1) to (13), it can also be constructed to include: a tubular catheter shaft, which has an inner cavity for the needle body to be inserted; and a catheter seat, which is arranged at the base end of the catheter shaft and has an inner cavity for the needle body to be inserted.

[0032] (15) A second embodiment of the present invention is a vascular puncture system comprising: a vascular puncture device as described in any one of items (1) to (14) above; a light receiving portion that receives the light derived from the light emitting portion; and an image display portion that displays a light-receiving image based on the light received by the light receiving portion.

[0033] According to such a configuration, even when the light emitted from the light guide tip portion is light of a wavelength that is difficult or impossible to visually recognize with the naked eye, the position of the light guide tip portion can be easily recognized.

[0034] According to the present invention, it can be quickly known that the front end opening of the needle body has been inserted into the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a schematic diagram of the structure of a vascular puncture system according to one embodiment of the present invention.

[0036] Figure 2 It is an exploded perspective view of a vascular puncture device.

[0037] Figure 3 It is a longitudinal cross-sectional view of a vascular puncture device.

[0038] Figure 4A This is an enlarged view of the front end of the vascular puncture device. Figure 4B yes Figure 4A Top view of the vascular puncture device.

[0039] Figure 5 This is a first explanatory diagram of a vascular puncture procedure using a vascular puncture device.

[0040] Figure 6 Yes Figure 5 An illustration of the light-receiving image of the state.

[0041] Figure 7 This is a second explanatory diagram of the above-mentioned puncture operation.

[0042] Figure 8 Yes Figure 7 An illustration of the light-receiving image of the state.

[0043] Figure 9 This is a third explanatory diagram of the above-mentioned puncture operation.

[0044] Figure 10A It is a partially omitted top view of a blood vessel puncture device according to a first modified example. Figure 10B It is a partially omitted top view of a blood vessel puncture device according to a second modified example.

[0045] Figure 11 1 is a longitudinal sectional view of a vascular puncture device according to a configuration example. DETAILED DESCRIPTION

[0046] like Figure 1 As shown, a vascular puncture system 12 according to one embodiment of the present invention includes a vascular puncture device 10 and a visualization device 14. The vascular puncture device 10 is configured as an indwelling needle (such as a peripheral arteriovenous indwelling needle or a dialysis indwelling needle) for administering an infusion (medicine solution) into a blood vessel 302 of a living body part 300. Alternatively, the vascular puncture device 10 may be a vascular access product such as a peripherally inserted central venous catheter (PICC), a midline catheter, or a central venous catheter. Furthermore, the vascular puncture device 10 may be a blood collection needle without a catheter.

[0047] like Figures 1 to 3 As shown, the vascular puncture device 10 includes a catheter 16, a needle 18, a light source unit 20, and a light guide 22. The catheter 16, needle 18, and light guide 22 are disposable items that are discarded after a single use. The light source unit 20 is a reusable item that can be used multiple times.

[0048] like Figure 2 and Figure 3 As shown, the catheter component 16 includes a flexible catheter shaft 24 and a catheter hub 28 disposed at the proximal end of the catheter shaft 24. The catheter shaft 24 is a tubular component that can be continuously inserted into a blood vessel 302 of a living body part 300. The catheter shaft 24 has a lumen 30 (drug solution supply path) extending axially throughout its entire length. The distal end of the catheter shaft 24 is open.

[0049] Examples of the constituent material of the catheter shaft 24 include fluororesins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA), olefin resins such as polyethylene and polypropylene, or mixtures thereof, polyurethane, polyester, polyamide, polyether nylon resin, and mixtures of olefin resins and ethylene-vinyl acetate copolymers.

[0050] like Figure 3 As shown, catheter hub 28 is formed into a hollow (cylindrical) shape. The proximal end portion of catheter shaft 24 is fixed to the distal end portion of catheter hub 28. Catheter hub 28 is preferably made of a material harder than catheter shaft 24. The material constituting catheter hub 28 is not particularly limited; for example, thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, and ABS resin can be suitably used. A hemostatic valve (not shown) may also be provided in lumen 32 of catheter hub 28.

[0051] like Figure 2 and Figure 3 As shown, the needle member 18 includes a needle body 36 and a needle hub 38 provided at the base end of the needle body 36. Inside the needle member 18, the light guide member 22 is inserted from the base end direction of the needle hub 38 to the front end of the needle body 36 (see Figure 3 ).

[0052] The needle body 36 is capable of puncturing a biological part 300 (see Figure 5 and Figure 7 ) is a rigid tubular component. The needle body 36 is formed into a circular tubular shape. The needle body 36 has an inner cavity 40 extending along the axial direction (refer to Figure 2 and Figure 4A ).like Figure 3 As shown, in the initial state (assembled state) of vascular puncture device 10, needle body 36 is inserted through lumen 30 of catheter shaft 24 and lumen 32 of catheter hub 28. Light guide member 22 is inserted through lumen 40 of needle body 36. That is, the inner diameter of needle body 36 is larger than the outer diameter of light guide member 22.

[0053] The needle body 36 is made of metal materials such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, etc. Alternatively, the needle body 36 may be made of resin materials such as polypropylene (PP), polycarbonate (PC), polyetheretherketone (PEEK), and liquid crystal polymer (LCP).

[0054] If needle body 36 is transparent, a light leakage prevention portion (not shown) is provided on the outer or inner circumference of needle body 36. The light leakage prevention portion is formed of an opaque material. For example, the light leakage prevention portion can be formed by coating the surface of needle body 36 with carbon black. Alternatively, the light leakage prevention portion can be formed by coating the surface of needle body 36 with a metal mirror, a multilayer film filter, or the like.

[0055] Needle body 36 is formed to be sufficiently longer than catheter shaft 24. In the initial state of blood vessel puncture device 10, needle body 36 protrudes from the front end of catheter shaft 24 toward the front end direction.

[0056] like Figure 4A As shown, a blade surface 42 inclined with respect to the axis of the needle body 36 is formed at the front end of the needle body 36. A front end opening 44 communicating with the inner cavity 40 of the needle body 36 is formed on the blade surface 42.

[0057] like Figure 3 As shown, the needle hub 38 includes a needle connection hole 46, an inner cavity 48, a first connection portion 50, a blood inlet portion 52, and a filter 54. The needle connection hole 46 is formed at the front end of the needle hub 38. The proximal end of the needle body 36 is inserted into the needle connection hole 46. The proximal end of the needle body 36 is fixed to the inner circumferential surface of the needle hub 38 forming the needle connection hole 46. The proximal end of the needle body 36 is located further forward than the proximal end of the needle connection hole 46.

[0058] The inner cavity 48 of the needle hub 38 is connected to the base end of the needle connection hole 46 and is open at the base end surface of the needle hub 38. A guide surface 56 is provided on the inner circumferential surface of the needle hub 38, which forms the inner cavity 48, for guiding the light guide member 22 toward the inner cavity 40 of the needle body 36. The guide surface 56 tapers toward the needle body 36 (toward the distal end). A first connecting portion 50 is provided at the base end of the needle hub 38. The first connecting portion 50 is a recessed portion (hole portion) that opens at the base end surface of the needle hub 38 and is connected to the inner cavity 48 of the needle hub 38.

[0059] The blood inflow portion 52 is a portion for confirming blood return. The blood inflow portion 52 includes: a first opening portion 58, which opens on the inner peripheral surface of the needle hub 38 forming the needle connection hole 46; and a second opening portion 60, which opens on the base end surface of the needle hub 38. The first opening portion 58 is located closer to the base end than the base end of the needle body 36. The second opening portion 60 is covered by a filter 54 fixed to the base end surface of the needle hub 38. The filter 54 allows the circulation of air but blocks the circulation of blood. The filter 54 functions as a blood circulation blocking portion that blocks the blood flowing into the blood inflow portion 52 from circulating toward the light source unit 20.

[0060] The area of the first opening 58 of the blood inlet 52 is larger than the cross-sectional area of the annular flow path formed in the needle connecting hole 46 between the outer peripheral surface of the light guide member 22 and the inner peripheral surface of the needle connecting hole 46 in the proximal direction relative to the first opening 58. Therefore, blood directed from the lumen 40 of the needle body 36 into the needle connecting hole 46 preferentially flows toward the blood inlet 52. In other words, blood flow into the lumen 48 of the needle hub 38 can be effectively suppressed.

[0061] The needle hub 38 is made of the same materials as those used for the needle body 36. The wall of the needle hub 38 includes a visual confirmation portion 62 for visually confirming blood flowing into the blood inflow portion 52 from the outside. The visual confirmation portion 62 is transparent.

[0062] The light source unit 20 is detachably attached to the base end of the needle hub 38. When the needle body 36 is inserted into the blood vessel 302 while the light source unit 20 is attached to the needle hub 38, the surface of the light source unit 20 facing the living body part 300 is flat (without a protrusion). This prevents the light source unit 20 from contacting the living body part 300 when the needle body 36 is inserted into the blood vessel 302.

[0063] The light source unit 20 includes a light source unit 64, a power supply unit 66, and a housing 68. The light source unit 64 is housed in the housing 68. The light source unit 64 emits light L1 toward the front end. Examples of the light source unit 64 include an LED, a lamp (e.g., a halogen lamp), and a laser irradiation unit (e.g., a laser diode). The light source unit 64 preferably emits directional light L1. Alternatively, the light source unit 64 may emit non-directional light L1.

[0064] The light source unit 64 emits light L1 in a wavelength range that is easily absorbed by hemoglobin in blood and easily transmits through the skin tissue 304. Specifically, the light source unit 64 emits at least one of visible light and near-infrared light. The wavelength of visible light is preferably 600 nm or greater and less than 700 nm. The wavelength of near-infrared light is 700 nm or greater and 2500 nm or less, preferably 700 nm or greater and 1400 nm or less, and more preferably 780 nm or greater and 940 nm or less.

[0065] The light L1 emitted by the light source unit 64 has a peak wavelength of not less than 600 nm and not more than 2500 nm. The light source unit 64 may also emit light L1 of multiple wavelengths simultaneously. That is, for example, the light source unit 64 may simultaneously emit visible light of 600 nm and near-infrared light of 850 nm. The light source unit 64 is capable of adjusting the brightness of the light L1. The light source unit 64 may be illuminated continuously or in a flashing manner.

[0066] The power supply unit 66 is provided at the base end portion of the housing 68. The power supply unit 66 supplies power to the light source unit 64. The power supply unit 66 includes, for example, a battery. As the battery, primary batteries, secondary batteries, solar cells, etc. can be listed. The power supply unit 66 can include a wireless power supply device, and can also include a plug-in plug that can be connected to a plug-in connector (socket) for wiring. The power supply unit 66 can be fixed to the base end portion of the housing 68 in a detachable manner, and can also be fixed to the base end portion of the housing 68 in an irremovable manner. In the case where the power supply unit 66 can be attached and detached relative to the housing 68, the mounting structure of the power supply unit 66 and the housing 68 can be a concave-convex interlocking structure, a claw engaging structure, an adsorption structure using a magnet, an engaging structure using a surface fastener, a screwing structure using a screw, etc. The power supply unit 66 can also be accommodated in the housing 68.

[0067] The housing 68 is formed in a tubular shape (e.g., a cylindrical shape) and includes a housing body 72 defining a housing space 70 for the light source 64 and a second connecting portion 74 that protrudes from the front end of the housing body 72 and is attachable to and detachable from the first connecting portion 50 of the needle hub 38.

[0068] The second connection portion 74 is a convex portion that can be engaged with the first connection portion 50 which is a concave portion. That is, the connection structure between the first connection portion 50 and the second connection portion 74 is a concave-convex interlocking structure. In addition, the connection structure between the first connection portion 50 and the second connection portion 74 can also be a claw engaging structure, an adsorption structure using a magnet, an engaging structure using a surface fastener, a screw-on structure, etc. At least one of the first connection portion 50 and the second connection portion 74 can also have a light release portion 88 (see Figure 4A ) is a positioning structure (not shown) directed toward the front end opening 44 of the needle body 36. The positioning structure may be, for example, a concave-convex structure.

[0069] The second connection portion 74 also serves as a support portion for the base end portion of the light guide member 22. The light guide member 22 is supported by the second connection portion 74 so that the axis of the light guide member 22 is coaxial with the optical axis of the light source unit 64. The light guide member 22 is also removable from the light source unit 20.

[0070] The base end surface of the light guide member 22 faces the light source unit 64. A space is provided between the base end surface of the light guide member 22 and the light source unit 64. A condenser lens (not shown) for condensing the light L1 emitted by the light source unit 64 onto the light guide member 22 may be disposed in the space between the base end surface of the light guide member 22 and the light source unit 64. Examples of the material constituting the condenser lens include glass and resin materials (e.g., acrylic resin).

[0071] Examples of materials for housing 68 include the materials used to construct needle body 36. Housing 68 is made of, for example, a material that does not transmit light L1 emitted by light source 64. Housing 68 can also be made of a transparent material. In this case, a light leakage prevention portion is provided on the outer or inner circumference of housing 68. The light leakage prevention portion of housing 68 is formed similarly to the light leakage prevention portion of needle body 36.

[0072] The outer peripheral surface of the housing 68 is preferably smooth and free of concavities and convexities so as to be easily cleaned with alcohol.

[0073] Light guide member 22 extends linearly along the axis of needle body 36. When light source unit 20 is mounted on needle hub 38, light guide member 22 is inserted into inner cavity 48 of needle hub 38, needle connection hole 46, and inner cavity 40 of needle body 36 from a position closer to the base of needle hub 38. The axis of light guide member 22 is located on the axis of needle body 36. Furthermore, the position of the axis of light guide member 22 may be offset relative to the position of the axis of needle body 36.

[0074] like Figure 4A As shown, the outer diameter of the light guide member 22 is smaller than the inner diameter of the needle body 36. That is, a blood introduction path 76 for guiding blood toward the proximal end is formed between the outer peripheral surface of the light guide member 22 and the inner peripheral surface of the needle body 36.

[0075] The light guide member 22 is formed solid. The light guide member 22 guides the light L1 emitted by the light source portion 64 to the front end opening 44 of the needle body 36. Examples of the light guide member 22 include optical fibers, acrylic rods, glass rods, and light emitting tubes. Figure 4A and Figure 4B As shown, a light-proof portion 78 is provided on at least a portion of the outer surface of the light guide member 22 to prevent the release of the light L1 emitted by the light source 64. The base end surface of the light guide member 22 is not covered by the light-proof portion 78 but is exposed.

[0076] The light-impermeable portion 78 is formed, for example, by coating the surface of the light guide member 22 with carbon black. Alternatively, the light-impermeable portion 78 may be formed by coating the surface of the light guide member 22 with a metal mirror, a multilayer film filter, or the like.

[0077] The light guide member 22 includes a light guide tip portion 82 that protrudes in the tip direction from the base end 80 of the tip opening 44 of the needle body 36. The tip of the light guide tip portion 82 is located closer to the base direction than the tip 84 of the tip opening 44 of the needle body 36. Specifically, the tip of the light guide tip portion 82 is located closer to the base direction than the center 86 of the tip opening 44 of the needle body 36 in the axial direction of the needle body 36 (see FIG. Figure 4B). The light guide tip 82 does not protrude outward from the front end opening 44 of the needle body 36. Thus, the blade 42 can smoothly puncture the biological part 300. In addition, at least a portion of the light guide tip 82 may protrude outward from the front end opening 44.

[0078] A light-releasing portion 88, not covered by the light-impermeable portion 78, is provided on the outer circumference of the light guide distal end portion 82. The light-releasing portion 88 releases light L1 in the direction toward the distal end opening 44 of the needle body 36. The light-impermeable portion 78 is provided on the entire outer circumference of the light guide member 22, excluding the light-releasing portion 88. The light-releasing portion 88 extends along the axial direction of the light guide member 22. The light-releasing portion 88 is formed, for example, in an elliptical shape.

[0079] like Figure 4B As shown, the length of the light releasing portion 88 along the circumference of the light guide tip 82 is less than half the circumference of the light guide tip 82. Specifically, the length of the light releasing portion 88 along the circumference of the light guide tip 82 is less than 1 / 8 of the length of the circumference of the light guide tip 82. In this case, the light L1 released from the light releasing portion 88 can be suppressed from spreading in the circumferential direction of the light guide tip 82. The base end of the light releasing portion 88 is located closer to the tip than the base end 80 of the front end opening 44 of the needle body 36. The size, shape, and number of the light releasing portions 88 can be appropriately set.

[0080] The light-impermeable portion 78 is provided over the entire front end surface 821 of the light guide front end portion 82. This prevents the light L1 from being emitted toward the front end of the light guide member 22. Specifically, this prevents the light L1 emitted toward the front end of the light guide member 22 from being diffusely reflected within the skin tissue 304, thereby preventing the light guide member 22 from excessively expanding its light-emitting area.

[0081] The light guide member 22 is not limited to the above-described structure. The light guide member 22 may also be hollow (tubular), with the inner lumen of the light guide member 22 functioning as a blood inlet passage 76 for guiding blood toward the blood inflow portion 52. In this case, the opaque portion 78 is also provided on the inner circumferential surface of the light guide member 22. This prevents the light L1 from being released toward the distal end of the light guide member 22 through the inner lumen of the light guide member 22.

[0082] The light-impermeable portion 78 need not be provided on the outer circumference of the portion of the light guide member 22 that is closer to the proximal end than the light guide distal end portion 82 (the light guide base portion 90). If the light-impermeable portion 78 is not provided on the outer circumference of the light guide base portion 90 and the needle hub 38 is made of a transparent material, a light leakage prevention portion is preferably provided on the outer or inner circumference of the needle hub 38. Furthermore, no light leakage prevention portion is provided on the visual confirmation portion 62 of the needle hub 38. The light leakage prevention portion of the needle hub 38 is formed similarly to the light leakage prevention portion of the needle body 36.

[0083] like Figure 1 As shown, the visualization device 14 includes an irradiation unit 92, a light receiving unit 94, and an image display unit 96. The irradiation unit 92 irradiates light L2 onto the biological part 300 (visualization object) punctured by the blood vessel puncture device 10. The irradiation unit 92 includes an irradiation unit main body 98 that emits light L2. The irradiation unit main body 98 emits near-infrared light as light L2. The wavelength of the near-infrared light emitted by the irradiation unit main body 98 is greater than or equal to 700 nm and less than or equal to 2500 nm, preferably greater than or equal to 700 nm and less than or equal to 1400 nm, and more preferably greater than or equal to 780 nm and less than or equal to 940 nm. In addition, the wavelength of light L1 and the wavelength of light L2 are preferably different from each other. The wavelength of light L1 and the wavelength of light L2 may also be the same as each other.

[0084] The light receiving unit 94 is arranged on the side opposite to the irradiation unit 92 across the biological part 300. In other words, the irradiation unit 92 and the light receiving unit 94 are arranged to face each other across the biological part 300. The light receiving unit 94 is a camera (photographing unit) for receiving the light L1 emitted by the light source unit 64 and the light L2 emitted by the irradiation unit 92. For example, a CCD camera for near-infrared light is used for the light receiving unit 94. Alternatively, the light receiving unit 94 may be a thin film capable of converting near-infrared light into visible light.

[0085] The image display unit 96 displays an image (received image 100) based on the light L2 received by the light receiving unit 94. The image display unit 96 may be wearable and removable goggles, a stationary display, or a projector.

[0086] In the visualization device 14, the irradiation unit 92 may be positioned on the side of the living body part 300 where the light receiving unit 94 is positioned. In this case, the light receiving unit 94 receives the light L2 (reflected light) reflected from the living body part 300, of the light L2 emitted by the irradiation unit 92. Alternatively, in the visualization device 14, the irradiation unit 92 may be positioned both on the side opposite the living body part 300 from the light receiving unit 94 and on the side of the living body part 300 where the light receiving unit 94 is positioned. In this case, the light L2 emitted by each irradiation unit 92, including both the light L2 that has passed through the living body part 300 (transmitted light) and the light L2 that has been reflected from the living body part 300 (reflected light), is received by the light receiving unit 94.

[0087] Next, an example of a puncture procedure on blood vessel 302 using blood vessel puncture device 10 will be described.

[0088] In the initial state of the blood vessel puncture device 10, the blade surface 42 projects from the front end opening 34 of the catheter shaft 24 in the state of facing upward (see Figure 3 ) In addition, the light source unit 20 is not attached to the needle holder 38. In addition, here, the case where the light source section 64 emits the light L1 including the near-infrared light will be described.

[0089] First, the user determines the necessity of light source unit 20 based on the patient's puncture target blood vessel 302. Specifically, if the user determines that light source unit 20 is unnecessary because puncture target blood vessel 302 is easily visible from the outside, the user performs the puncture operation of needle body 36 into blood vessel 302 without attaching light source unit 20 to needle hub 38.

[0090] On the other hand, if the user determines that light source unit 20 is necessary because it is difficult to externally grasp blood vessel 302 to be punctured, the user attaches second connection portion 74 of light source unit 20 to first connection portion 50 of needle hub 38 .

[0091] Next, the user sets the visualization device 14. Specifically, Figure 5 As shown, an irradiation unit 92 is disposed below a living body part 300 (e.g., a human forearm), and a light receiving unit 94 is disposed above the living body part 300. Then, the living body part 300 is irradiated with light L2 from the irradiation unit 92, and the distal end of the needle body 36 is inserted into the living body part 300 (at a position closer to the epidermis than the blood vessel 302).

[0092] Then, light L2 emitted by irradiation unit 92 passes through skin tissue 304 of living body part 300 while being scattered, and the transmitted light L2 (transmitted light) is received by light receiving unit 94. At this time, hemoglobin in the blood flowing in blood vessel 302 absorbs light L2. Light L2 does not pass through needle body 36.

[0093] Light L1 emitted by the light source unit 64 is guided toward the distal end by the light guide member 22 and released from the light release portion 88 in the direction (upward) toward the distal end opening 44 of the needle body 36. Light L1 released from the light release portion 88 diffuses while passing through the skin tissue 304 of the living body part 300. The transmitted light L1 (transmitted light) is received by the light receiving portion 94. At this time, light L1 is not released toward the distal end of the light guide member 22. Therefore, diffuse reflection of light L1 toward the distal end of the light guide member 22 is suppressed.

[0094] Therefore, if Figure 6 As shown, a light receiving image 100 based on the light L2 received by the light receiving unit 94 is displayed on the image display unit 96. In the light receiving image 100, for example, skin tissue 304, blood vessels 302, and the distal end of the needle body 36 are displayed.

[0095] Specifically, in the light-receiving image 100, the light-emitting portion 88 of the light-guiding member 22 appears brightest (white), while the skin tissue 304 appears darker than the light-receiving portion 88. Furthermore, in the light-receiving image 100, the blood vessels 302 and the needle body 36 appear darker than the skin tissue 304. This allows the user to easily and clearly distinguish between the blood vessels 302 and the needle body 36 in the light-receiving image 100.

[0096] Then, if Figure 7 As shown, when the distal end opening 44 of the needle body 36 is inserted into the blood vessel 302, the light L1 emitted by the light source 64 is absorbed by the hemoglobin in the blood. Therefore, the light L1 does not reach the light receiving portion 94, or even if it reaches the light receiving portion 94, the intensity is greatly reduced.

[0097] Therefore, if Figure 8 As shown, in the light-receiving image 100, the appearance of the light-guiding distal end portion 82 changes (the light-releasing portion 88 becomes darker). In other words, the brightness of the light-releasing portion 88 becomes lower than the brightness of the blood vessel 302. Furthermore, the brightness of the needle body 36 becomes lower than the brightness of the blood vessel 302. Therefore, the user can easily and quickly understand from the light-receiving image 100 that the distal end opening 44 of the needle body 36 has been inserted into the blood vessel 302 (the needle body 36 is securing the blood vessel).

[0098] Furthermore, the blood in the blood vessel 302 is introduced from the front end opening 44 of the needle body 36 through the blood introduction path 76 of the needle body 36 into the blood inlet portion 52. At this time, the air in the inner cavity 40 of the needle body 36 and the blood inlet portion 52 is discharged to the outside through the filter 54. Therefore, the blood is smoothly introduced into the blood inlet portion 52 of the needle hub 38. Then, by visually confirming the blood introduced into the blood inlet portion 52, the user can know that the front end opening 44 of the needle body 36 has been inserted into the blood vessel 302 (the needle body 36 secures the blood vessel).

[0099] At this time, the flow of blood in the blood inflow portion 52 toward the proximal end is blocked by the filter 54. Therefore, the blood in the blood inflow portion 52 does not come into contact with the light source unit 20.

[0100] Then, if Figure 9 As shown, the user removes the needle member 18 from the catheter member 16 while the catheter shaft 24 is indwelling in the blood vessel 302 , and administers a medical solution into the blood vessel 302 through the lumen 30 of the catheter shaft 24 .

[0101] The light source unit 20 is removed from the needle holder 38, and the light guide member 22 is removed from the light source unit 20. The light source unit 20 is reused. The used needle member 18 and light guide member 22 are discarded.

[0102] However, in this embodiment, when the light source unit 64 emits only visible light, the user can recognize the light L1 emitted from the light emitting unit 88 before the needle body 36 is secured in a blood vessel. On the other hand, when the needle body 36 is secured in a blood vessel, this light L1 is absorbed by hemoglobin in the blood, making it impossible for the user to recognize the light L1 emitted from the light emitting unit 88. Therefore, even when the light source unit 64 emits only visible light, the user can easily and quickly recognize that the needle body 36 is secured in a blood vessel based on the light L1 emitted by the light source unit 64.

[0103] This embodiment has the following effects.

[0104] According to this embodiment, the light L1 emitted by the light source unit 20 is released from the light release portion 88 of the light guide tip 82 through the tip opening 44 of the needle body 36. Therefore, it is possible to quickly determine that the tip opening 44 of the needle body 36 has been inserted into the blood vessel 302. Furthermore, since the outer surface of the light guide tip 82 includes the opaque portion 78, the amount of light L1 released from the light guide tip 82 can be suppressed. This suppresses diffuse reflection within the skin tissue 304, narrowing the light-emitting area of the light guide tip 82. Therefore, the position of the tip opening 44 of the needle body 36 within the skin tissue 304 can be determined more accurately. Consequently, the needle body 36 can be inserted into the blood vessel 302 with high precision.

[0105] The light-impermeable portion 78 is provided on the front end surface 821 of the light guide front end portion 82 .

[0106] This structure can reduce the amount of light emitted toward the distal end of the needle body 36, thereby narrowing the light-emitting region of the light-guiding distal end 82 within the skin tissue 304. Therefore, the needle body 36 can be inserted into the blood vessel 302 with greater precision.

[0107] The light-impermeable portion 78 is provided on the entire front end surface 821 of the light guide front end portion 82 .

[0108] According to such a structure, diffuse reflection in the skin tissue 304 can be further suppressed.

[0109] The light-impermeable portion 78 is provided on the outer peripheral surface of the light guide tip portion 82 .

[0110] According to such a configuration, since it is possible to suppress the emission of unnecessary light L1 from the outer peripheral surface of the light guide tip portion 82 , it is possible to further suppress diffuse reflection in the skin tissue 304 .

[0111] The length of the light releasing portion 88 along the circumferential direction of the light guide tip portion 82 is equal to or less than half the circumference of the light guide tip portion 82 .

[0112] According to such a configuration, diffuse reflection in the skin tissue 304 can be effectively suppressed.

[0113] The light source unit 20 emits near-infrared light.

[0114] According to this structure, near-infrared light can more easily pass through the skin tissue 304 and be more easily absorbed by hemoglobin than visible light, so that it can be more easily known that the distal end opening 44 of the needle body 36 has been inserted into the blood vessel 302 .

[0115] The light source unit 20 is attachable to and detachable from the needle holder 38 .

[0116] With such a configuration, whether or not to emit light from the light guide tip 82 can be selected according to the position of the blood vessel 302 or the user's skill.

[0117] The light guide member 22 is provided on the light source unit 20 . The inner surface of the needle hub 38 has a guide surface 56 that tapers toward the inner cavity 40 of the needle body 36 .

[0118] With such a configuration, when the light source unit 20 is mounted on the needle hub 38 , the light guide base portion 90 can be easily inserted into the inner cavity 40 of the needle body 36 via the guide surface 56 .

[0119] A blood introduction path 76 for guiding blood toward the needle hub 38 is provided in the needle body 36 or the light guide member 22. The needle hub 38 is provided with a blood inflow portion 52 for checking flashback into which the blood guided from the blood introduction path 76 flows.

[0120] According to such a configuration, it is possible to confirm again that the distal end opening 44 of the needle body 36 has been inserted into the blood vessel 302 by the inflow of blood into the blood inflow portion 52 .

[0121] The needle hub 38 is provided with a filter 54 (blood circulation blocking portion) that blocks the blood flowing into the blood inflow portion 52 from flowing toward the light source unit 20 .

[0122] According to such a configuration, the light source unit 20 can be prevented from coming into contact with blood by the filter 54. Therefore, when the light source unit 20 is detachable from the needle hub 38, the light source unit 20 can be reused.

[0123] Vascular puncture system 12 includes: vascular puncture device 10 ; light receiving unit 94 for receiving light L1 emitted from light emitting unit 88 ; and image display unit 96 for displaying a light-receiving image 100 based on light L1 received by light receiving unit 94 .

[0124] According to such a configuration, even when the light L1 emitted from the light emitting portion 88 is difficult to visually confirm or cannot be visually confirmed with the naked eye, the position of the distal end opening 44 of the needle body 36 can be easily confirmed.

[0125] (First Modification)

[0126] Next, the light guide member 22a of the first modified example will be described. Figure 10A As shown in FIG. 1 , a plurality of light releasing portions 88a are provided on the light guide member 22a. The light releasing portion 88a is formed into a perfect circular shape. The plurality of light releasing portions 88a are arranged at intervals along the axial direction of the light guide member 22a. Figure 10A In the example of FIG. 5 , the plurality of light releasing portions 88 a are arranged at equal intervals along the axial direction of the light guide member 22 a .

[0127] In this modification, a plurality of light releasing portions 88a are arranged at intervals from each other along the axial direction of the light guide member 22a.

[0128] According to this structure, when the front end opening 44 of the needle body 36 is inserted into the blood vessel 302, the light emitting portion 88a gradually becomes invisible from the front end direction, so the user can easily understand the extent to which the front end opening 44 of the needle body 36 is inserted into the blood vessel 302.

[0129] (Second Modification)

[0130] Next, the light guide member 22b of the second modified example will be described. Figure 10B As shown, the light guide member 22b is provided with a light releasing portion 88b extending in an annular shape along the circumference of the light guide tip 82. The length of the light releasing portion 88b along the axial direction of the light guide member 22b can be appropriately set.

[0131] In this modification, the light releasing portion 88 b extends in a ring shape along the circumferential direction of the light guide tip portion 82 .

[0132] According to such a configuration, it is unnecessary to position the light releasing portion 88 b and the distal end opening 44 of the needle body 36 in the circumferential direction of the light guide distal end portion 82 .

[0133] (Configuration Example)

[0134] Next, a configuration example of a vascular puncture device 10a will be described. In this configuration example, the same reference numerals are used for the same structures as those of the above-mentioned vascular puncture device 10, and detailed descriptions thereof will be omitted. Figure 11 As shown, blood vessel puncture device 10a includes catheter member 16, needle member 18a, light source unit 20a, and hollow (tubular) light guide member 22.

[0135] The needle component 18a includes a needle body 36 and a needle hub 38a. The needle hub 38a includes a first component 110 and a second component 112. The first component 110 has a needle connection hole 46, an inner cavity 113, and a first engaging portion 114. The base end of the needle body 36 is located at the base end of the needle connection hole 46. Alternatively, the base end of the needle body 36 may be located further forward than the base end of the needle connection hole 46. The first engaging portion 114 is a recessed portion (hole portion) that opens on the base end surface of the first component 110 and communicates with the inner cavity 113 of the first component 110.

[0136] The second component 112 includes a support portion 116 and a filter 54. The support portion 116 is formed to be hollow. The support portion 116 supports the filter 54 arranged in the support portion 116. A second engaging portion 118 engaging with the first engaging portion 114 is provided at the front end portion of the support portion 116. The second engaging portion 118 is a convex portion that fits into the first engaging portion 114, which is a concave portion. However, the first engaging portion 114 may be a convex portion and the second engaging portion 118 may be a concave portion. The support portion 116 is fixed relative to the first component 110. The support portion 116 may also be integrally formed with the first component 110.

[0137] The second engaging portion 118 supports the base end portion of the light guide member 22. In other words, the base end portion of the light guide member 22 is fixed to the second engaging portion 118. The supporting portion 116 has a blood flow path 120 in the base end direction of the second engaging portion 118. The blood flow path 120 is connected to the inner cavity of the light guide member 22. The inner cavity 113 of the first component 110 and the blood flow path 120 form a blood inflow portion 122 for confirming blood flashback, which guides the blood flowing in from the front end opening 44 of the needle body 36. In addition, the filter 54 is configured to block the blood flow path 120 from the base end direction.

[0138] A mounting portion 124 for mounting the light source unit 20a is provided in the support portion 116 at a position closer to the base end than the filter 54. The mounting portion 124 is a recess (hole) opened in the base end surface of the support portion 116. The mounting portion 124 is located on the axis of the needle body 36.

[0139] The light source unit 20a is detachably attached to the mounting portion 124. The light source unit 20a includes a light source portion 64, a power supply portion 66, and a housing 126. The housing 126 includes a housing body 72 and a connecting portion 128. The connecting portion 128 is a convex portion that fits into the concave portion of the mounting portion 124. A light extraction hole 130 communicating with the storage space 70 is formed in the connecting portion 128. The light extraction hole 130 opens at the front end of the connecting portion 128.

[0140] In this configuration, light guide member 22 does not need to be removed when light source unit 20a is removed from needle hub 38a. In other words, after use of vascular puncture device 10a, light guide member 22 can be discarded along with needle hub 38a as a disposable item. Furthermore, since light source unit 20a can be attached and detached from second member 112, exposure of light source unit 20a to blood can be effectively reduced.

[0141] In this configuration example, blood vessel puncture device 10 a may include light guide member 22 a or light guide member 22 b described above instead of light guide member 22 .

[0142] The vascular puncture device 10 is not limited to the above structure. At least a portion of the light guide component 22 may be fixed to the needle component 18. The light guide component 22 may be separated into a first portion fixed to the needle component 18 and a second portion fixed to the light source unit 20. In this case, when the light source unit 20 is mounted on the needle seat 38, the first portion and the second portion are optically connected to form a continuous light path. In addition, the entire light guide component 22 may be fixed to the needle component 18. In this case, the light source unit 20 can be easily loaded and unloaded relative to the needle seat 38. The light guide component 22 may be intermittent in the axial direction of the light guide component 22. The light source unit 20 may also be fixed to the needle seat 38 in an unremovable manner.

[0143] Blood vessel puncture device 10 is not limited to the above-described structure. Light release portion 88 may be provided on front end surface 821 of light guide front end portion 82.

[0144] In addition, the present invention is not limited to the above disclosure, and various structures can be adopted without departing from the gist of the present invention.

[0145] Description of Reference Numerals

[0146] 10, 10a…vascular puncture device; 12…vascular puncture system; 20…light source unit; 22, 22a, 22b…light guiding component; 24…catheter shaft; 28…catheter seat; 36…needle body; 38, 38a…needle seat; 40…inner cavity of needle body; 42…blade surface; 44…front end opening of needle body; 52…blood inflow portion; 54…filter (blood flow blocking portion); 56…guide surface; 76…blood inlet path; 78…light-proof portion; 80…base end with front end opening; 82…light guiding front end portion; 88, 88a, 88b…light releasing portion; 94…light receiving portion; 96…image display portion; 100…light-received image; 300…biological part; 302…blood vessel; L1, L2…light.

Claims

1. A blood vessel puncture device, characterized in that: have: A tubular needle body capable of puncturing a blood vessel in a living body; a needle hub disposed at the base end of the needle body; and a light source unit, which is arranged on the needle seat, The front end portion of the needle body has: blade surface; and A front opening is formed on the blade surface and communicates with the inner cavity of the needle body. A light guide member for guiding the light emitted by the light source unit toward the front end opening is arranged in the inner cavity of the needle body. The light guide member has a light guide front end portion protruding toward the front end direction from the base end of the front end opening. The outer surface of the light guide front end portion has: a light releasing portion that releases the light in a direction toward which the front end opening faces; and A light-proof portion prevents the release of the light.

2. The blood vessel puncture device according to claim 1, characterized in that: The light-proof portion is arranged on the front end surface of the light guide front end portion.

3. The blood vessel puncture device according to claim 2, characterized in that: The light-proof portion is provided on the entire front end surface of the light guide front end portion.

4. The blood vessel puncture device according to claim 1, characterized in that: The light releasing portion and the light-impermeable portion are provided on an outer peripheral surface of the light guide front end portion.

5. The blood vessel puncture device according to claim 4, characterized in that: The light releasing portion extends along the axial direction of the light guide member.

6. The blood vessel puncture device according to claim 4, characterized in that: A plurality of the light releasing portions are arranged at intervals from each other along the axial direction of the light guide member.

7. The blood vessel puncture device according to claim 4, characterized in that: The light releasing portion extends in a ring shape along a circumferential direction of the light guide front end portion.

8. The blood vessel puncture device according to claim 4, characterized in that: The length of the light releasing portion along the circumference of the light guide front end portion is less than or equal to half the circumference of the light guide front end portion.

9. The blood vessel puncture device according to claim 1, characterized in that: The light source unit emits near-infrared light.

10. The blood vessel puncture device according to claim 1, characterized in that: The light source unit is attachable to and detachable from the needle holder.

11. The blood vessel puncture device according to claim 10, characterized in that: The light guide component is provided on the light source unit, The inner surface of the needle seat has a guiding surface that is tapered toward the inner cavity of the needle body.

12. The blood vessel puncture device according to claim 1, characterized in that: The needle body or the light guide member is provided with a blood introduction path for guiding blood toward the needle seat. The needle hub is provided with a blood inflow portion for checking flashback into which the blood guided from the blood introduction path flows.

13. The blood vessel puncture device according to claim 12, characterized in that: The needle hub is provided with a blood flow blocking portion that blocks the blood flowing into the blood inflow portion from flowing toward the light source unit.

14. The blood vessel puncture device according to claim 1, characterized in that: have: a tubular catheter shaft having an inner lumen for the needle to pass through; and The catheter seat is provided at the base end portion of the catheter shaft and has an inner cavity for the needle body to pass through.

15. A vascular puncture system, characterized in that: have: The blood vessel puncture device according to any one of claims 1 to 14; a light receiving portion that receives the light guided out from the light releasing portion; and An image display unit displays a light-receiving image based on the light received by the light-receiving unit.

Images