Blood vessel puncture device and blood vessel puncture system

Abstract

In a blood vessel puncture device (12), the distal end part (54) of a light guide member (22) is positioned closer to the proximal end side than a needle opening (44). An inner light transmission part (90) that faces a light emission part (88) of the distal end part (54) of the light guide member (22) is provided on a side, of a needle body (36), that is closer to the proximal end than a blade surface (42). The distal end part (25) of a catheter shaft (24) is provided with an outer light transmission part (94) that faces the inner light transmission part (90). A liquid-tight structure (86) is provided between the outer peripheral surface of the distal end part (54) of the light guide member (22) and the inner peripheral surface (37) of the needle body (36).

Description

Vascular puncture device and vascular puncture system

[0001] The present invention relates to a vascular puncture device and a vascular puncture system.

[0002] Japanese Patent No. 6734392 and Japanese Patent No. 7036735 disclose a blood vessel puncture device including a tubular needle body, a needle hub, and a light guiding member. The tip of the needle body is capable of puncturing a blood vessel in a living body. The needle hub is provided at the base end of the needle body. The light guiding member is inserted into the lumen of the needle body. Light emitted from the tip of the light guiding member is emitted to the outside of the needle body through a needle opening formed at the tip of the needle body.

[0003] When the needle is inserted into a living body part, if the tip of the needle has not yet reached a blood vessel, the light emitted from the light-guiding member passes through the skin, etc., and the light can be seen from outside the living body part. On the other hand, if the tip of the needle is inserted into a blood vessel, the light emitted from the light-guiding member is absorbed by the blood, and the light cannot be seen from outside the living body part. By capturing this change in the appearance of the light, it is possible to confirm whether the tip of the needle has entered a blood vessel.

[0004] Patent No. 6734392 Patent No. 7036735

[0005] The blood vessel puncture device further includes a tubular catheter shaft. The needle body is inserted through the catheter shaft. In the blood vessel puncture device, after the needle body has punctured the blood vessel, the tip of the catheter shaft is inserted into the blood vessel. By removing the needle body and needle hub from the catheter shaft while the tip of the catheter shaft remains indwelling in the blood vessel, it becomes possible to administer a medicinal solution into the blood vessel via the lumen of the catheter shaft.

[0006] However, in the blood vessel puncture devices of Japanese Patent Nos. 6734392 and 7036735, only the needle opening emits light, so it is not possible to confirm whether the tip of the catheter shaft has been inserted into the blood vessel. It is desirable to be able to confirm whether the tip of the catheter shaft has been inserted into the blood vessel.

[0007] The present invention aims to solve the above-mentioned problems.

[0008] (1) A first aspect of the present invention is a blood vessel puncture device comprising: a tubular catheter shaft; a catheter hub provided at a proximal end of the catheter shaft; a tubular needle body inserted through the catheter shaft and the catheter hub and capable of puncturing a blood vessel at a living body site; the needle hub provided at the proximal end of the needle body; a light guide member inserted into an inner cavity of the needle body; and a light source unit that supplies light to the light guide member, wherein the distal end of the catheter shaft has a catheter opening communicating with the inner cavity of the catheter shaft, and the distal end of the needle body has a blade surface and a needle opening formed on the blade surface and communicating with the inner cavity of the needle body, and protrudes from the catheter opening in a distal direction; a light-guiding member that guides the light emitted by the light source unit; a tip of the light-guiding member is located proximal to the needle opening; an outer surface of the tip of the light-guiding member has a light-emitting portion that emits the light radially outward from the light-guiding member; an inner light-transmitting portion that faces the light-emitting portion and is capable of transmitting the light is provided on the wall of the needle body proximal to the blade surface; an outer light-transmitting portion that faces the inner light-transmitting portion and is capable of transmitting the light is provided on the wall of the tip of the catheter shaft; and a liquid-tight structure is provided between the outer surface of the tip of the light-guiding member and the inner surface of the needle body to prevent blood from flowing between the light-emitting portion and the inner light-transmitting portion.

[0009] With this configuration, the distal end of the light-guiding member is located closer to the proximal end than the needle opening (in the lumen of the catheter shaft), and the light emitting portion of the light-guiding member, the inner light-transmitting portion of the needle, and the outer light-transmitting portion of the catheter shaft are all radially opposed to each other. As a result, when light emitted by the light source unit is guided by the light-guiding member, the light emitted from the light emitting portion passes through the inner light-transmitting portion and the outer light-transmitting portion and is emitted to the outside of the catheter shaft.

[0010] As a result, when the distal end of the catheter shaft is not inserted into a blood vessel at a living body part, the light emitted from the light emitting unit to the outside of the catheter shaft can be easily confirmed, whereas when the distal end of the catheter shaft is inserted into a blood vessel, the light emitted from the light emitting unit to the outside of the catheter shaft becomes difficult to confirm because it is absorbed by the blood.

[0011] Therefore, in the present invention, it is possible to easily check whether the distal end of the catheter shaft is inserted into a blood vessel.

[0012] Furthermore, with this configuration, the liquid-tight structure prevents blood from flowing between the light emitting portion and the inner light transmitting portion, so that the light emitted from the light emitting portion is not absorbed by the blood when it passes through the inner light transmitting portion, thereby preventing a decrease in the amount of light emitted outside the catheter shaft due to absorption of the light by the blood.

[0013] Furthermore, with this configuration, the light guide member does not protrude from the blade surface toward the tip, so when the needle body is inserted into a blood vessel at a living body part, the light guide member does not get in the way of the insertion.

[0014] (2) In the vascular puncture device described in (1) above, the liquid-tight structure may be formed by liquid-tight contact between the outer surface of the tip of the light-guiding member and the inner surface of the needle body.

[0015] With this configuration, the outer surface of the tip of the light-guiding member and the inner circumferential surface of the needle are in liquid-tight contact, which effectively prevents blood from penetrating between the light emitting portion and the inner light-transmitting portion, thereby effectively preventing the light emitted from the light emitting portion from being absorbed by blood as it passes through the inner light-transmitting portion and the outer light-transmitting portion, thereby effectively preventing a decrease in the amount of light emitted outside the catheter shaft.

[0016] (3) In the blood vessel puncture device described in (1) or (2) above, the inner light-transmitting portion may have a light-transmitting hole that penetrates the wall portion of the needle body.

[0017] According to this configuration, the inner light transmitting portion can be easily configured by forming a light transmitting hole in the wall of the needle body, and the light emitted from the light emitting portion can be easily emitted to the outside of the catheter shaft.

[0018] (4) In the vascular puncture device described in (3) above, the inner light-transmitting portion may have a plurality of the light-transmitting holes, and the plurality of light-transmitting holes may be spaced apart in the axial direction of the needle body in the wall portion of the needle body.

[0019] With this configuration, when the distal end of the catheter shaft is inserted into a blood vessel, light that passes through the light-transmitting holes that are inserted into the blood vessel is absorbed by the blood. Furthermore, light that passes through the light-transmitting holes that are not inserted into the blood vessel is emitted outside the living body part without being absorbed by the blood. Therefore, by determining the number of light-transmitting holes that can be seen from outside the living body part (the number of light-transmitting holes that are emitting light), it is possible to easily determine how far the catheter shaft has been inserted into the blood vessel.

[0020] (5) In the vascular puncture device described in any one of (1) to (4) above, a light quantity suppression section may be provided between the tip surface of the light-guiding member and the needle opening to suppress the amount of light emitted from the tip surface of the light-guiding member to the needle opening.

[0021] According to this configuration, by suppressing the amount of light emitted from the tip surface of the light-guiding member to the outside of the needle body, it is possible to relatively increase the amount of light emitted from the light emitting section to the outside of the catheter shaft.

[0022] (6) In the vascular puncture device described in any one of (1) to (5) above, the needle body or the light-guiding member may be provided with a blood introduction path for guiding the blood to the needle hub, and the needle hub may be provided with a blood inlet section for checking flashback, into which the blood introduced from the blood introduction path flows.

[0023] With this configuration, blood flows into the blood inlet portion, making it possible to confirm that the needle opening has been inserted into the blood vessel.

[0024] (7) In the vascular puncture device described in any one of (1) to (6) above, an attachment portion may be provided at the base end of the needle hub, and the light source unit may be detachably attached to the attachment portion of the needle hub.

[0025] According to this configuration, since the light source unit is detachable from the needle hub, the light source unit can be made into a reusable item that can be used (reused) multiple times.

[0026] (8) In the blood vessel puncture device according to any one of (1) to (7) above, the needle hub and the light source unit may be integrally configured.

[0027] According to this configuration, the needle hub and the light source unit can be made into disposable items that are discarded after a single use.

[0028] (9) In the blood vessel puncture device described in any one of (1) to (8) above, the needle body or the light-guiding member may be provided with a blood introduction path for guiding the blood to the needle hub, the blood vessel puncture device may further include a blood circulation blocking section provided at the base end of the needle hub and having an attachment section, the light source unit may be detachable from the attachment section of the blood circulation blocking section, and the blood circulation blocking section may prevent the blood that has flowed into the needle hub from circulating to the light source unit.

[0029] This configuration prevents the light source unit from coming into contact with blood. In addition, because the light source unit is detachable from the blood flow blocking portion, the light source unit can be reused multiple times.

[0030] (10) In the blood vessel puncture device according to any one of (1) to (9) above, the light-guiding member may be hollow.

[0031] According to this configuration, the inside of the light guide member can be used as a blood introduction channel.

[0032] (11) In the blood vessel puncture device according to any one of (1) to (10) above, the light-guiding member may be an optical fiber.

[0033] With this configuration, the light emitted by the light source unit can be effectively guided.

[0034] (12) A second aspect of the present invention is a blood vessel puncture system comprising a blood vessel puncture device according to any one of (1) to (11) above, a light receiving unit that receives the light emitted from the light emitting unit, and an image display unit that displays a received light image created based on the light received by the light receiving unit.

[0035] With this configuration, even if the light emitted from the light emitting unit has a wavelength that is difficult or impossible to see with the naked eye, it is possible to easily confirm whether the tip of the catheter shaft has been inserted into a blood vessel.

[0036] According to the present invention, the distal end of the light-guiding member is located closer to the proximal end than the needle opening (in the lumen of the catheter shaft), and the light emitting portion provided on the light-guiding member, the inner light-transmitting portion provided on the needle body, and the outer light-transmitting portion provided on the catheter shaft are radially opposed to each other. As a result, when light emitted by the light source unit is guided by the light-guiding member, the light emitted from the light emitting portion passes through the inner light-transmitting portion and the outer light-transmitting portion and is emitted to the outside of the catheter shaft.

[0037] As a result, when the distal end of the catheter shaft is not inserted into a blood vessel at a living body part, the light emitted from the light emitting unit to the outside of the catheter shaft can be easily confirmed, whereas when the distal end of the catheter shaft is inserted into a blood vessel, the light emitted from the light emitting unit to the outside of the catheter shaft becomes difficult to confirm because it is absorbed by the blood.

[0038] Therefore, in the present invention, it is possible to easily check whether the distal end of the catheter shaft is inserted into a blood vessel.

[0039] Furthermore, according to the present invention, the liquid-tight structure prevents blood from flowing between the light emitting portion and the inner light transmitting portion, so that when light emitted from the light emitting portion passes through the inner light transmitting portion, the light is not absorbed by the blood, thereby preventing a decrease in the amount of light emitted outside the catheter shaft due to absorption of the light by the blood.

[0040] Furthermore, according to the present invention, since the light guide member does not protrude from the blade surface toward the tip, the light guide member does not interfere with the needle body when it is inserted into a blood vessel at a living body site.

[0041] Furthermore, according to the present invention, even if the light emitted from the light emitting unit has a wavelength that is difficult or impossible to see with the naked eye, it is possible to easily confirm whether the tip of the catheter shaft has been inserted into a blood vessel.

[0042] FIG. 1 is a schematic diagram of a blood vessel puncture system and a blood vessel puncture device according to a first embodiment. FIG. 2 is an exploded perspective view of the blood vessel puncture device of FIG. 1. FIG. 3 is a longitudinal sectional view of the blood vessel puncture device of FIG. 1. FIG. 4 is a sectional view taken along line IV-IV of FIG. 3. FIG. 5 is a partial sectional view showing another configuration of the inner light-transmitting section. FIG. 6 is a partial sectional view showing another configuration of the outer light-transmitting section. FIG. 7 is a first explanatory diagram of a blood vessel puncture procedure using the blood vessel puncture device of FIG. 1. FIG. 8 is an explanatory diagram showing a received light image in the state of FIG. 7. FIG. 9 is a second explanatory diagram of the puncture procedure. FIG. 10 is an explanatory diagram showing a received light image in the state of FIG. 9. FIG. 11 is a third explanatory diagram of the puncture procedure. FIG. 12 is an explanatory diagram showing a received light image in the state of FIG. 11. FIG. 13 is a fourth explanatory diagram of the puncture procedure. FIG. 14 is a longitudinal sectional view of a blood vessel puncture device according to a second embodiment.

[0043] As shown in FIG. 1, a vascular puncture system 10 according to a first embodiment of the present invention includes a vascular puncture device 12 and a visualization device 14.

[0044] The vascular puncture device 12 is configured as an indwelling needle (such as a peripheral arterial or venous indwelling needle or a dialysis indwelling needle) for administering an infusion (e.g., a medicinal solution) into a blood vessel 302 of a living body site 300. The vascular puncture device 12 may also be a vascular access product such as a peripherally inserted central venous catheter (PICC), a midline catheter, or a central venous catheter.

[0045] 1 and 2, the vascular puncture device 12 includes a catheter member 16, a needle member 18, a light source unit 20, and a light guiding member 22. The catheter member 16, the needle member 18, and the light guiding member 22 are disposable items that are discarded after a single use, while the light source unit 20 is a reusable item that can be used multiple times.

[0046] As shown in FIG. 2, the catheter member 16 includes a catheter shaft 24 and a catheter hub 26 .

[0047] The catheter shaft 24 is flexible. As shown in FIG. 3 , the catheter shaft 24 is a tubular member. The catheter shaft 24 can be continuously inserted into a blood vessel 302 (see FIG. 13 ) at a living body site 300. The catheter shaft 24 has an inner lumen 28. The inner lumen 28 of the catheter shaft 24 extends along the axial direction of the catheter shaft 24. A catheter opening 32 is formed at the tip of the catheter shaft 24. The catheter opening 32 is a tip opening of the catheter shaft 24. The catheter opening 32 communicates the inner lumen 28 of the catheter shaft 24 with the outside of the catheter shaft 24.

[0048] Examples of materials that can be used for 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 copolymer. At least the distal end 25 of the catheter shaft 24 is made of a material that is transmissive to light L1 (light L2). The portion of the catheter shaft 24 that is proximal to the distal end 25 may be transmissive to light L1 (light L2), or may be opaque to light L1 (light L2). Therefore, the entire catheter shaft 24 may be made of a material that is transmissive to light L1 (light L2). Furthermore, if the portion of the catheter shaft 24 that is proximal to the distal end 25 is opaque to light L1 (light L2), the proximal portion may be coated or blended with a material that is opaque to light L1 so as not to reflect light L1.

[0049] The catheter hub 26 is hollow (cylindrical). The proximal end of the catheter shaft 24 is fixed to the distal end of the catheter hub 26. The catheter hub 26 is preferably made of a material harder than the catheter shaft 24. The material of the catheter hub 26 is not particularly limited, but suitable materials include thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, and ABS resin. A hemostatic valve (not shown) may be provided in the lumen 34 of the catheter hub 26.

[0050] As shown in FIGS. 2 and 3, the needle member 18 includes a needle body 36 and a needle hub 38 .

[0051] The needle body 36 is a cylindrical member. As shown in Figure 3, the needle body 36 has a lumen 40. The lumen 40 extends along the axial direction of the needle body 36. The needle body 36 has sufficient rigidity to puncture a biological site 300 (see Figure 7). The needle body 36 is inserted through the lumen 28 of the catheter shaft 24 and the lumen 34 of the catheter hub 26 in the initial state (assembled state) of the vascular puncture device 12 shown in Figure 3.

[0052] The needle body 36 is made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, a titanium alloy, etc. Alternatively, the needle body 36 may be made of a resin material such as polypropylene (PP), polycarbonate (PC), polyether ether ketone (PEEK), or liquid crystal polymer (LCP).

[0053] The needle 36 is preferably made of a material that is opaque to the light L1 emitted by the light source unit 20. If the needle 36 is transparent, a light leakage prevention portion (not shown) is provided on the inner circumferential surface 37 or outer circumferential surface of the needle 36. The light leakage prevention portion is made of an opaque material. The light leakage prevention portion is formed, for example, by painting the inner circumferential surface 37 or outer circumferential surface of the needle 36 with carbon black. The light leakage prevention portion may also be formed by coating the inner circumferential surface 37 or outer circumferential surface of the needle 36 with a metal mirror, a multilayer filter, or the like.

[0054] The needle 36 is formed to be sufficiently long compared to the catheter shaft 24. In the initial state of the blood vessel puncture device 12 shown in Figures 1 and 3, the needle 36 protrudes distally from the catheter opening 32. That is, the tip 39 of the needle 36 protrudes distally from the catheter opening 32.

[0055] As shown in Figure 3, a blade surface 42 inclined with respect to the axis of the needle body 36 is formed at the tip 39 of the needle body 36. A needle opening 44 is formed at the blade surface 42. The needle opening 44 is an opening at the tip of the needle body 36. The needle opening 44 connects the lumen 40 of the needle body 36 with the outside of the needle body 36.

[0056] The light-guiding member 22 is a tubular member. The lumen 46 of the light-guiding member 22 extends along the axial direction of the light-guiding member 22. The light-guiding member 22 is inserted into the lumen 40 of the needle 36. When the needle 36 is inserted into a blood vessel 302 (see FIGS. 9 and 11 ), blood flows back from the blood vessel 302 into the needle 36. The lumen 46 of the light-guiding member 22 and a portion of the lumen 40 of the needle 36 between the blade surface 42 and the distal end surface 48 of the light-guiding member 22 form a blood introduction path 50 for guiding the backflowing blood from the needle opening 44 of the needle 36 to the needle hub 38. A communication hole 52 communicating with the lumen 46 of the light-guiding member 22 is formed on the proximal end side of the wall of the light-guiding member 22. The light-guiding member 22 is made of a material that is transmissive to light L1 emitted by the light source unit 20. The light guide member 22 guides the light L1 to a tip portion 54 of the light guide member 22. Examples of such a light guide member 22 include an optical fiber, an acrylic rod, a glass rod, and a light emitting tube.

[0057] Because the light source unit 20 is a reusable product, the light-guiding member 22 may have a structure that prevents blood flowing backward through the lumen 46 of the light-guiding member 22 from leaking into the light source unit 20. Specifically, a blood exposure prevention portion (not shown) is provided in a portion of the light-guiding member 22 that is closer to the base end than the communicating hole 52. The blood exposure prevention portion is, for example, a stopper or filter that is arranged in the lumen 46 closer to the base end than the communicating hole 52. Alternatively, the portion of the light-guiding member 22 that is closer to the base end than the communicating hole 52 may be made solid, and the solid structure may function as a blood flow prevention portion. In either case, the blood flow prevention portion can prevent blood flowing backward through the lumen 46 of the light-guiding member 22 from leaking into the light source unit 20.

[0058] The light-guiding member 22 may be a solid linear member that is transmissive to light L1. Because the light-guiding member 22 is inserted into the lumen 40 of the needle body 36, it is not possible to check for backflow of blood (flashback). In this case, it is possible to check for the occurrence of flashback by checking for the presence or absence of light emission from the light-emitting unit 88, which will be described later. However, in consideration of the standards for the blood vessel puncture device 12, it is desirable that the light-guiding member 22 be a hollow linear member (tubular member). The following description will be given assuming that the light-guiding member 22 is a tubular member.

[0059] The needle hub 38 is hollow (cylindrical). The base end of the needle 36 is fixed to the distal end of the needle hub 38. The needle hub 38 has a needle connection hole 56, a lumen 58, an attachment portion 60, a blood inlet portion 62, and a filter 64.

[0060] The lumen 58 of the needle hub 38 extends along the axial direction of the needle hub 38. The needle connection hole 56 is formed at the distal end of the needle hub 38. The needle connection hole 56 connects the lumen 58 of the needle hub 38 to the outside of the needle hub 38. The proximal end of the needle body 36 is inserted into the needle connection hole 56. The proximal end of the needle body 36 is fixed to the inner circumferential surface of the needle hub 38 that forms the needle connection hole 56. The proximal end of the needle body 36 is located closer to the distal end than the proximal end of the needle connection hole 56.

[0061] The lumen 58 of the needle hub 38 opens to the proximal end face of the needle hub 38. A guide surface 66 is provided on the inner peripheral surface of the needle hub 38 that forms the lumen 58 of the needle hub 38. The guide surface 66 tapers in diameter toward the needle body 36 (toward the distal end). The guide surface 66 guides the light guiding member 22 into the lumen 40 of the needle body 36.

[0062] The proximal end side of the light guiding member 22 extends in the proximal direction from the proximal end of the needle body 36. The proximal end side of the light guiding member 22 passes through the needle connecting hole 56 and the inner cavity 58 inside the needle hub 38. The communication hole 52 of the light guiding member 22 is located inside the needle hub 38, closer to the proximal end than the needle body 36. In FIG. 3 , the communication hole 52 is located in the needle connecting hole 56. The communication hole 52 may also be located in the inner cavity 58.

[0063] The mounting portion 60 is provided at the proximal end of the needle hub 38. The mounting portion 60 is a recess (hole) that opens to the proximal end surface of the needle hub 38 and communicates with the inner cavity 58 of the needle hub 38.

[0064] The blood inlet 62 is a portion for checking for backflow (flashback) of blood. The blood inlet 62 includes a first opening 68 and a second opening 70. The first opening 68 opens on the inner circumferential surface of the needle hub 38 that forms the needle connection hole 56. The first opening 68 is located closer to the proximal end than the proximal end of the needle body 36. The second opening 70 opens on the proximal surface of the needle hub 38. The second opening 70 may also open on the side of the needle hub 38. The filter 64 is fixed to the proximal surface of the needle hub 38. The filter 64 covers the second opening 70. The filter 64 allows air to pass through. The filter 64 also functions as a blood flow blocking portion that prevents blood that has flowed into the blood inlet 62 from flowing to the light source unit 20.

[0065] The opening area of ​​the first opening 68 of the blood inlet 62 is larger than the flow path area of ​​the needle connection hole 56 on the proximal side of the first opening 68. This allows blood introduced into the needle connection hole 56 via the communication hole 52 of the light-guiding member 22 to flow preferentially into the blood inlet 62. As described above, a blood exposure prevention portion (not shown) is provided in the lumen 46 of the light-guiding member 22 on the proximal side of the communication hole 52. This effectively prevents blood from flowing into the light source unit 20. The flow path area of ​​the needle connection hole 56 on the proximal side of the first opening 68 is the flow path area between the inner circumferential surface of the needle connection hole 56 and the outer circumferential surface 23 of the light-guiding member 22.

[0066] The needle hub 38 may be made of the same material as the needle body 36. The wall of the needle hub 38 has a viewing portion 72 for visually observing from the outside the blood that has flowed into the blood inlet portion 62. The viewing portion 72 is transparent or semi-transparent.

[0067] The light source unit 20 is detachably attached to the proximal end of the needle hub 38. When the needle body 36 is inserted into the blood vessel 302 with the light source unit 20 attached to the needle hub 38, the surface of the light source unit 20 facing the biological site 300 is formed flat (having no convex portion). Therefore, when the needle body 36 is inserted into the blood vessel 302, the light source unit 20 is prevented from hitting the biological site 300.

[0068] The light source unit 20 has a light source section 74, a power supply section 76, and a housing 78. The light source section 74 is housed in the housing 78. The light source section 74 emits light L1 in the distal direction. The light source section 74 may be, for example, an LED, a lamp (e.g., a halogen lamp), or a laser irradiation unit (e.g., a laser diode). The light source section 74 preferably emits directional light L1. However, the light source section 74 may also emit non-directional light L1.

[0069] The light source unit 74 emits light L1 in a wavelength range that is easily absorbed by blood and easily transmitted through skin tissue 304 (see FIG. 7 ). Specifically, the light source unit 74 emits at least one of visible light and near-infrared light. The wavelength of the visible light is preferably 600 nm or more and less than 700 nm. The wavelength of the near-infrared light is 700 nm or more and 2500 nm or less, preferably 700 nm or more and 1400 nm or less, and more preferably 780 nm or more and 940 nm or less.

[0070] The light L1 emitted by the light source unit 74 has a peak wavelength of 600 nm or more and 2500 nm or less. The light source unit 74 may simultaneously emit light L1 of multiple wavelengths. That is, the light source unit 74 may simultaneously emit, for example, visible light of 600 nm and near-infrared light of 850 nm. The light source unit 74 is capable of adjusting the brightness of the light L1. The light source unit 74 may be lit continuously or may flash.

[0071] The power supply unit 76 is provided at the base end of the housing 78. The power supply unit 76 supplies power to the light source unit 74. The power supply unit 76 includes, for example, a battery. Examples of the battery include a primary battery, a secondary battery, a solar cell, etc. The power supply unit 76 may include a wireless power supply device or a plug connectable to a wired power connector (outlet). The power supply unit 76 may be detachable from the base end of the housing 78, or may be permanently fixed thereto. When the power supply unit 76 is detachable from the housing 78, the attachment structure between the power supply unit 76 and the housing 78 may be, for example, a recess-and-projection fitting structure, a claw engagement structure, a magnetic attraction structure, a hook-and-loop fastener engagement structure, a screw-threaded engagement structure, etc. The power supply unit 76 may be housed within the housing 78.

[0072] The housing 78 is formed in a tubular (e.g., cylindrical) shape. The housing 78 has a housing main body 80 and a connecting portion 82. An accommodation space 84 for accommodating the light source unit 74 is formed inside the housing main body 80. The connecting portion 82 protrudes distally from the distal end of the housing main body 80. The connecting portion 82 is detachable from the attachment portion 60 of the needle hub 38.

[0073] Specifically, the connecting portion 82 is a convex portion that can fit into the recessed portion of the mounting portion 60. In other words, the connection structure between the mounting portion 60 and the connecting portion 82 is a convex-concave fitting structure. Note that the connection structure between the mounting portion 60 and the connecting portion 82 may be a claw engagement structure, a magnetic attraction structure, a hook-and-loop fastener engagement structure, a screw engagement structure, or the like.

[0074] The light source unit 20 and the needle hub 38 may be integrally configured. In this case, the catheter member 16, the needle member 18, and the light guide member 22 are used as disposable items that are discarded after a single use.

[0075] An insertion hole 85 is formed inside the connecting portion 82. The insertion hole 85 connects the storage space 84 to the outside of the housing main body 80. The insertion hole 85 is formed coaxially with the optical axis of the light source unit 74. The inner diameter of the insertion hole 85 is larger than the outer diameter of the light guide member 22. The base end of the light guide member 22 is inserted into the insertion hole 85. Therefore, the axis of the light guide member 22 is coaxial with the optical axis of the light source unit 74. Therefore, the light source unit 20 is detachable from the attachment portion 60 while the light guide member 22 is inserted into the lumen 40 of the needle body 36. Note that the inner diameter of the insertion hole 85 may be slightly larger than the outer diameter of the light guide member 22 so that the connecting portion 82 supports the base end of the light guide member 22. In this case, the light source unit 20 is fixed to the attachment portion 60. That is, the light source unit 20 and the needle hub 38 are integrally configured and cannot be detached.

[0076] The base end surface of the light-guiding member 22 faces the light source unit 74. An accommodation space 84 is formed between the base end surface of the light-guiding member 22 and the light source unit 74. A condenser lens (not shown) that condenses the light L1 emitted by the light source unit 74 onto the light-guiding member 22 may be disposed in the accommodation space 84. Examples of materials that can be used for the condenser lens include glass and resin materials (e.g., acrylic resin).

[0077] Examples of materials that can be used for the housing 78 include the materials that can be used for the needles 36. The housing 78 is made of, for example, a material that does not transmit the light L1 emitted by the light source unit 74. The housing 78 may also be made of a transparent material. In this case, a light leakage prevention portion is provided on the outer or inner surface of the housing 78. The light leakage prevention portion of the housing 78 is formed in the same manner as the light leakage prevention portion of the needles 36.

[0078] The outer peripheral surface of the housing 78 is preferably a smooth surface without any irregularities so that it can be easily wiped with alcohol. When the connection part 82 is attached to the attachment part 60, the light guide member 22 and the light source part 74 are positioned on the axis of the needle body 36.

[0079] The light guiding member 22 extends along the axial direction of the needle body 36. The light guiding member 22 is inserted from the proximal direction into the inner cavity 58 of the needle hub 38, the needle connection hole 56, and the inner cavity 40 of the needle body 36. The axis of the light guiding member 22 is located on the axis of the needle body 36. Note that the position of the axis of the light guiding member 22 may be offset from the position of the axis of the needle body 36.

[0080] The tip portion 54 of the light-guiding member 22 is located closer to the proximal end than the needle opening 44 of the needle body 36. Specifically, the tip portion 54 of the light-guiding member 22 is located closer to the proximal end than the catheter opening 32 of the catheter shaft 24. Therefore, the tip portion 54 of the light-guiding member 22 is located in the lumen 28 of the catheter shaft 24.

[0081] As described above, the light-guiding member 22 is made of a material that is transmissive to light L1. Therefore, as shown in FIGS. 3 and 4 , at least a portion of the outer circumferential surface (the tip portion of the outer circumferential surface 23) of the tip portion 54 of the light-guiding member 22 is configured as a light emitting portion 88. The light emitting portion 88 emits a portion of the light L1 guided to the tip portion 54 of the light-guiding member 22 radially outward as light L2. In FIG. 2 , a circular light emitting portion 88 is formed on the outer circumferential surface (the tip portion of the outer circumferential surface 23) of the tip portion 54 of the light-guiding member 22. In this case, the portion of the outer circumferential surface 23 of the light-guiding member 22 other than the light emitting portion 88 may be transmissive to light L1 (light L2), or may be formed with a light-opaque portion that is opaque to light L1 (L2).

[0082] As shown in FIGS. 3 and 4 , an inner light-transmitting portion 90 is provided on the wall of the needle body 36 proximal to the blade surface 42. The inner light-transmitting portion 90 is provided in the lumen 28 of the catheter shaft 24 so as to face the light emitting portion 88. In this case, the most distal end of the inner light-transmitting portion 90 is located proximal to the most distal end (distal surface 48) of the light-guiding member 22. The inner light-transmitting portion 90 is capable of transmitting light L2 emitted from the light emitting portion 88. More specifically, the inner light-transmitting portion 90 has one light-transmitting hole 92. The light-transmitting hole 92 penetrates the wall of the needle body 36. The light-transmitting hole 92 may be a circular or elliptical through-hole. As described above, the needle body 36 is made of a material that is opaque to light L1 (light L2). Therefore, light L2 emitted from the light emitting portion 88 only passes through the inner light-transmitting portion 90 and does not pass through the wall of the needle body 36. The light transmitting hole 92 may be filled with a light transmitting member such as glass.

[0083] 5, the inner light-transmitting portion 90 may have a plurality of light-transmitting holes 92 penetrating the wall of the needle 36. In this case, the plurality of light-transmitting holes 92 are provided in the wall of the needle 36 at intervals in the axial direction of the needle 36. As a result, each of the plurality of light-transmitting holes 92 transmits light L2 emitted from the light emitting portion 88.

[0084] 3 and 4 , the outer diameter of the light-guiding member 22 is approximately the same as the inner diameter of the needle body 36. A liquid-tight structure 86 for preventing blood from flowing between the light emitting portion 88 and the inner light-transmitting portion 90 is provided between the outer peripheral surface of the tip portion 54 of the light-guiding member 22 and the inner peripheral surface 37 of the needle body 36. The liquid-tight structure 86 is formed by liquid-tight contact (surface contact or line contact) between the outer peripheral surface of the tip portion 54 of the light-guiding member 22 and the inner peripheral surface 37 of the needle body 36. As described above, the most distal end of the inner light-transmitting portion 90 is located closer to the base end than the most distal end (tip surface 48) of the light-guiding member 22, and the light emitting portion 88 and the inner light-transmitting portion 90 face each other in the radial direction. Therefore, for example, the liquid-tight structure 86 may be configured by a portion of the outer peripheral surface of the tip portion 54 of the light-guiding member 22 surrounding the light emitting portion 88 and a portion of the inner peripheral surface 37 of the needle body 36 surrounding the inner light-transmitting portion 90 being in liquid-tight contact with each other without any gaps. Alternatively, the liquid-tight structure 86 may be configured by a portion of the outer peripheral surface of the tip portion 54 of the light-guiding member 22 being in liquid-tight contact with the inner peripheral surface 37 of the needle body 36 on the distal side of the inner light-transmitting portion 90, over the entire circumference around the axis of the needle body 36. By configuring the liquid-tight structure 86 in this manner, when the tip portion 39 of the needle body 36 punctures a blood vessel 302 (see FIGS. 9 and 11 ), blood flowing back from the blood vessel 302 flows into the needle hub 38 through the lumen 46 of the light-guiding member 22, which constitutes the blood introduction channel 50.

[0085] An outer light-transmitting portion 94 is provided on the wall of the tip portion 25 of the catheter shaft 24. The outer light-transmitting portion 94 faces the inner light-transmitting portion 90. The outer light-transmitting portion 94 is capable of transmitting light L2 that has passed through the inner light-transmitting portion 90. In other words, the outer light-transmitting portion 94 diffusely reflects the light L2 that has passed through the inner light-transmitting portion 90 to the outside of the catheter shaft 24.

[0086] When the entire catheter shaft 24 is made of a material that is transmissive to light L2, the distal end 25 of the catheter shaft 24 serves as the outer light-transmitting portion 94. Alternatively, only the distal end 25 (outer light-transmitting portion 94) of the catheter shaft 24 may be transmissive to light L2, with the portion of the catheter shaft 24 proximal to the distal end 25 being opaque to light L2. Therefore, it is sufficient for at least the outer light-transmitting portion 94 of the catheter shaft 24 to be transmissive to light L2. Therefore, the entire catheter shaft 24 may be made of a transparent or translucent material. Alternatively, only the outer light-transmitting portion 94 of the catheter shaft 24 may be made of a transparent or translucent material, with the portion of the catheter shaft 24 other than the outer light-transmitting portion 94 being made of a material that is opaque to light L2.

[0087] As shown in Figure 6, the outer light-transmitting portion 94 may be made of a material containing a fluorescent dye or the like. In this case, the outer light-transmitting portion 94 emits the fluorescence of the light L2 that has passed through the inner light-transmitting portion 90 to the outside of the catheter shaft 24. In this case, the portion of the catheter shaft 24 proximal to the distal end 25 may be transmissive to the light L2 or may be opaque to the light L2. The outer light-transmitting portion 94 may be formed by subjecting the distal end 25 of the catheter shaft 24 to a texturing process, a multifaceted process, or the like, or by incorporating a reflective material. In either case, the light L2 can be diffusely reflected to increase the amount of light.

[0088] As shown in FIG. 3 , a light amount suppressing section 96 is provided between the distal end surface 48 of the light-guiding member 22 and the needle opening 44. A portion of the light L1 guided to the distal end 54 of the light-guiding member 22 is emitted from the distal end surface 48 in the distal direction as light L3. The light L3 emitted from the distal end surface 48 is emitted from the needle opening 44 to the outside of the needle body 36. The light amount suppressing section 96 suppresses the amount of light emitted from the distal end surface 48. Specifically, the light amount suppressing section 96 is provided in an annular shape on the distal end surface 48 of the light-guiding member 22. Therefore, the light amount suppressing section 96 is provided closer to the base end than the needle opening 44.

[0089] The light amount suppressing unit 96 is formed by coloring the distal end surface 48 of the light-guiding member 22 with a dye that is opaque to the light L3. Alternatively, the light amount suppressing unit 96 may be an optical filter that does not transmit the light L3. Furthermore, the light amount suppressing unit 96 may be an annular filter disposed on the distal end surface 48 of the light-guiding member 22. In this case, the filter is an optical filter that suppresses the amount of light while allowing blood and medicinal solutions to pass through.

[0090] As shown in FIG. 1 , the visualization device 14 includes an irradiation unit 100, a light receiving unit 102, and an image display unit 104. The irradiation unit 100 irradiates light L4 onto a biological site 300 (visualization target) punctured by the vascular puncture device 12. The irradiation unit 100 includes an irradiation unit main body 106 that emits light L4. The irradiation unit main body 106 emits near-infrared light as light L4. The wavelength of the near-infrared light emitted by the irradiation unit main body 106 is 700 nm or more and 2500 nm or less, preferably 700 nm or more and 1400 nm or less, and more preferably 780 nm or more and 940 nm or less. Note that the wavelengths of light L1 (L2, L3) and light L4 are preferably different from each other. The wavelengths of light L1 (L2, L3) and light L4 may be the same.

[0091] The light receiving unit 102 is disposed on the opposite side of the biological part 300 from the irradiation unit 100. In other words, the irradiation unit 100 and the light receiving unit 102 are disposed facing each other with the biological part 300 in between. The light receiving unit 102 is a camera (image capturing unit) for receiving light L2 emitted by the light emitting unit 88, light L3 emitted from the distal end surface 48 of the light-guiding member 22, and light L4 emitted by the irradiation unit 100. For example, a CCD camera for near-infrared light is used as the light receiving unit 102. Alternatively, the light receiving unit 102 may be a film capable of converting near-infrared light into visible light.

[0092] The image display unit 104 displays an image (a received light image 108) created based on the light L2, L3, and L4 received by the light receiving unit 102. The image display unit 104 may be a pair of goggles that can be worn by a person, a fixed display, or a projector.

[0093] In the visualization device 14, the irradiation unit 100 may be arranged on the side of the biological part 300 where the light receiving unit 102 is located. In this case, the light receiving unit 102 receives light L4 emitted by the irradiation unit 100 that is reflected by the biological part 300 (reflected light). Furthermore, in the visualization device 14, the irradiation unit 100 may be arranged on both the opposite side of the biological part 300 from the light receiving unit 102 and the side of the biological part 300 where the light receiving unit 102 is located. In this case, of the light L4 emitted by each irradiation unit 100, both light L4 that is transmitted through the biological part 300 (transmitted light) and light L4 that is reflected by the biological part 300 (reflected light) are received by the light receiving unit 102.

[0094] Next, an example of a procedure for puncturing the blood vessel 302 with the blood vessel puncture device 12 will be described with reference to FIGS.

[0095] The user prepares the blood vessel puncture device 12. In the initial state of the blood vessel puncture device 12 (see FIGS. 1 and 3), the blade surface 42 faces upward and protrudes distally from the catheter opening 32 of the catheter shaft 24. Also, in the initial state, the light source unit 20 is pre-attached to the attachment portion 60 of the needle hub 38. Alternatively, the user may attach the light source unit 20 to the attachment portion 60 of the needle hub 38 when they determine that the blood vessel 302 to be punctured is difficult to grasp from the outside and that the light source unit 20 is necessary.

[0096] Next, the user sets up the visualization device 14. Specifically, as shown in FIG. 7 , the user places the irradiation unit 100 below the biological part 300 (e.g., a human forearm) and the light receiving unit 102 above the biological part 300. In this case, the user places the light receiving unit 102 parallel to the blood vessel puncturing device 12 that will be inserted into the biological part 300, and places the irradiation unit 100, for example, on the opposite side of the light receiving unit 102 with the biological part 300 in between. The user also places the light receiving unit 102 so that the light receiving unit 102 and the outer light transmitting unit 94 face each other. Next, the user irradiates the biological part 300 with light L4 from the irradiation unit 100 and inserts the tip 39 of the needle body 36 into the biological part 300 (at a position closer to the epidermis than the blood vessel 302).

[0097] As a result, light L4 emitted by the irradiation unit 100 passes through the skin tissue 304 of the living body part 300 while being scattered. At this time, the blood flowing through the blood vessels 302 absorbs the light L4. The light L4 that has passed through the living body part 300 (transmitted light) is received by the light receiving unit 102. Note that the light L4 does not pass through the needle body 36.

[0098] Furthermore, the visible light or near-infrared light L1 emitted by the light source unit 74 is supplied to the light guide member 22. The light guide member 22 guides the supplied light L1 to the tip portion 54 of the light guide member 22.

[0099] A portion of the light L1 guided to the distal end 54 of the light-guiding member 22 is emitted as light L2 from the light emitting unit 88 in the radial direction of the light-guiding member 22. The light L2 emitted from the light emitting unit 88 passes through the inner light-transmitting unit 90 and the outer light-transmitting unit 94 and is emitted radially to the outside of the catheter shaft 24. At this time, the light L2 emitted from the light emitting unit 88 is diffusely reflected by the inner light-transmitting unit 90 and the outer light-transmitting unit 94 and is emitted radially to the outside of the catheter shaft 24. The light L2 passes through the skin tissue 304 of the biological site 300 while being scattered. The light L2 that has passed through the biological site 300 is received by the light-receiving unit 102. As described above, the vascular puncture device 12 and the light-receiving unit 102 face each other, so the light-receiving unit 102 can easily receive the light L2. This increases the amount of light received by the light-receiving unit 102.

[0100] Furthermore, a portion of the light L1 guided to the distal end 54 of the light-guiding member 22 is emitted as light L3 from the distal end surface 48 of the light-guiding member 22 in the distal direction. The light L3 emitted from the distal end surface 48 of the light-guiding member 22 is emitted in the distal direction from the needle opening 44 via the light amount suppression unit 96. The light L3 passes through the skin tissue 304 of the biological part 300 while being scattered. The light L3 that has passed through the biological part 300 is received by the light-receiving unit 102.

[0101] In this case, the amount of light L3 emitted from the distal end surface 48 of the light-guiding member 22 is suppressed by the light-amount suppression unit 96. As a result, the amount of light emitted from the distal end surface 48 of the light-guiding member 22 to the outside of the needle body 36 is less than the amount of light emitted from the light emitting unit 88 to the outside of the catheter shaft 24. In other words, the amount of light emitted from the light emitting unit 88 to the outside of the catheter shaft 24 is relatively greater. Therefore, the light-receiving unit 102 can receive light L2, which has a relatively large amount of light, and light L3, which has a relatively small amount of light.

[0102] 8, the image display unit 104 displays a received-light image 108 created based on the light L2, L3, and L4 received by the light receiving unit 102. The received-light image 108 displays, for example, skin tissue 304, blood vessels 302, the tip 39 of the needle body 36, the tip 25 of the catheter shaft 24, and the like.

[0103] As described above, because the amount of light emitted from the light emitting portion 88 is relatively large, the outer light transmitting portion 94 at the tip portion 25 of the catheter shaft 24 appears brightest (white) in the received light image 108. Furthermore, because the amount of light emitted from the tip surface 48 of the light-guiding member 22 is relatively small, the needle opening 44 of the needle body 36 appears darker than the outer light transmitting portion 94 in the received light image 108. Furthermore, in the received light image 108, the skin tissue 304 appears darker than the outer light transmitting portion 94 and the needle opening 44 of the needle body 36. Furthermore, in the received light image 108, the blood vessel 302 and the needle body 36 appear darker than the skin tissue 304. This allows the user to easily and clearly distinguish between the tip portion 25 of the catheter shaft 24 (outer light transmitting portion 94), the needle body 36 (needle opening 44 of the needle body 36), and the blood vessel 302 in the received light image 108.

[0104] 9, when the needle opening 44 of the needle body 36 is inserted into the blood vessel 302, the light L3 emitted from the distal end surface 48 of the light-guiding member 22 is absorbed by the blood. As a result, the light L3 does not reach the light-receiving unit 102, or even if it does reach the light-receiving unit 102, its intensity is greatly reduced.

[0105] 1 and 10 , the appearance of the needle opening 44 changes in the received-light image 108 (the needle opening 44 becomes darker). In other words, the brightness of the needle opening 44 becomes equal to or lower than the brightness of the blood vessel 302. Therefore, the user can easily and quickly know from the received-light image 108 that the needle opening 44 of the needle body 36 has been inserted into the blood vessel 302 (the needle body 36 has secured the blood vessel).

[0106] Furthermore, blood in the blood vessel 302 is guided from the needle opening 44 of the needle body 36 through the blood introduction channel 50 and into the blood inlet section 62. At this time, air in the blood introduction channel 50 and the blood inlet section 62 passes through the filter 64 and is discharged to the outside. Therefore, the blood is smoothly guided into the blood inlet section 62 of the needle hub 38. By visually checking the blood guided into the blood inlet section 62, the user can know that the needle opening 44 of the needle body 36 has been inserted into the blood vessel 302 (the blood vessel has been secured by the needle body 36). Note that, because the flow of blood in the blood inlet section 62 toward the proximal end is blocked by the filter 64, the blood in the blood inlet section 62 does not come into contact with the light source unit 20.

[0107] 11 , when the distal end 25 of the catheter shaft 24 is inserted into a blood vessel 302, the light L2 emitted from the light emitting portion 88 through the inner light transmitting portion 90 and the outer light transmitting portion 94 (the distal end 25 of the catheter shaft 24) is absorbed by the blood. As a result, the light L2 does not reach the light receiving portion 102, or even if it does reach the light receiving portion 102, its intensity is greatly reduced.

[0108] 12, the appearance of the outer light-transmitting portion 94 changes in the received-light image 108 (the outer light-transmitting portion 94 becomes darker). In other words, the brightness of the outer light-transmitting portion 94 becomes equal to or lower than the brightness of the blood vessel 302. Therefore, the user can easily and quickly know from the received-light image 108 that the distal end 25 of the catheter shaft 24 has been inserted into the blood vessel 302 (the catheter shaft 24 has secured the blood vessel).

[0109] After confirming that the catheter shaft 24 has secured the blood vessel, the user removes the needle member 18 (see FIG. 1) from the catheter member 16 while leaving the catheter shaft 24 in the blood vessel 302, as shown in FIG. 13. After removing the needle member 18, the user administers a medicinal solution into the blood vessel 302 via the lumen 28 of the catheter shaft 24.

[0110] The user also removes the light source unit 20 from the needle hub 38. The light source unit 20 is reused. The used needle member 18 and light guide member 22 are discarded.

[0111] In the first embodiment, light L2, light L3, and light L4 may be received by separate light receiving units (first to third light receiving units). In this case, the first light receiving unit that receives light L2 is disposed to face the outer light transmitting unit 94. The second light receiving unit that receives light L3 is disposed to face the needle opening 44. The third light receiving unit that receives light L4 is disposed to face the biological site 300. A received light image 108 can be created by combining an image created based on light L2 received by the first light receiving unit, an image created based on light L3 received by the second light receiving unit, and an image created based on light L4 received by the third light receiving unit.

[0112] The first embodiment has the following advantages.

[0113] As shown in Figure 3, the tip portion 54 of the light-guiding member 22 is located closer to the base end than the needle opening 44 (in the lumen 28 of the catheter shaft 24), and the light emitting portion 88 provided on the light-guiding member 22, the inner light-transmitting portion 90 provided on the needle body 36, and the outer light-transmitting portion 94 provided on the catheter shaft 24 are all radially opposed to each other (see Figure 4). As a result, when light L1 emitted by the light source unit 20 is guided by the light-guiding member 22, light L2 emitted from the light emitting portion 88 passes through the inner light-transmitting portion 90 and the outer light-transmitting portion 94 and is emitted to the outside of the catheter shaft 24.

[0114] As a result, when the tip 25 of the catheter shaft 24 is not inserted into the blood vessel 302 of the biological site 300 (see FIGS. 7 and 9), the light L2 emitted from the light emitting unit 88 to the outside of the catheter shaft 24 can be easily confirmed (see FIGS. 1, 8 and 10). On the other hand, when the tip 25 of the catheter shaft 24 is inserted into the blood vessel 302 (see FIG. 11), the light L2 emitted from the light emitting unit 88 to the outside of the catheter shaft 24 is absorbed by the blood and becomes difficult to confirm (see FIG. 12).

[0115] Therefore, in the first embodiment, it is possible to easily check whether the distal end portion 25 of the catheter shaft 24 is inserted into the blood vessel 302 or not.

[0116] Furthermore, the liquid-tight structure 86 prevents blood from flowing between the light emitting portion 88 and the inner light transmitting portion 90, so that the light L2 emitted from the light emitting portion 88 is not absorbed by the blood when it passes through the inner light transmitting portion 90. As a result, it is possible to prevent the light L2 from being absorbed by the blood and the amount of light emitted to the outside of the catheter shaft 24 from decreasing.

[0117] Furthermore, since the light guide member 22 does not protrude from the blade surface 42 in the distal direction, when the needle body 36 is inserted into the blood vessel 302 of the living body part 300, the light guide member 22 does not get in the way of the insertion.

[0118] The outer peripheral surface (outer surface) of the tip portion 54 of the light-guiding member 22 and the inner peripheral surface 37 of the needle body 36 are in liquid-tight contact, which effectively prevents blood from entering between the light emitting portion 88 and the inner light-transmitting portion 90. This effectively prevents the light L2 emitted from the light emitting portion 88 from being absorbed by the blood when it passes through the inner light-transmitting portion 90 and the outer light-transmitting portion 94, thereby effectively preventing a decrease in the amount of light emitted outside the catheter shaft 24.

[0119] 4, the inner light-transmitting portion 90 can be easily formed by forming a light-transmitting hole 92 in the wall of the needle body 36. Furthermore, the light L2 emitted from the light emitting portion 88 can be easily emitted to the outside of the catheter shaft 24.

[0120] 5 , the inner light-transmitting portion 90 has a plurality of light-transmitting holes 92, which are provided in the wall of the needle 36 at intervals in the axial direction of the needle 36. Therefore, when the tip 25 of the catheter shaft 24 is inserted into a blood vessel 302, light L2 that passes through the light-transmitting holes 92 that are inserted into the blood vessel 302 is absorbed by the blood. Furthermore, light L2 that passes through the light-transmitting holes 92 that are not inserted into the blood vessel 302 is emitted outside the biological site 300 without being absorbed by the blood. Thus, by knowing the number of light-transmitting holes 92 that can be seen from outside the biological site 300 (the number of light-transmitting holes 92 that are emitting light), it is possible to easily determine how far the catheter shaft 24 has been inserted into the blood vessel 302.

[0121] As shown in Figure 3, by using the light amount suppression section 96 to suppress the amount of light emitted from the tip surface 48 of the light-guiding member 22 to the outside of the needle body 36, the amount of light emitted from the light emitting section 88 to the outside of the catheter shaft 24 can be relatively increased.

[0122] The flow of blood into the blood inlet portion 62 confirms that the needle opening 44 has been inserted into the blood vessel 302 .

[0123] Since the light source unit 20 is detachable from the needle hub 38, the light source unit 20 can be made into a reusable item that can be used (reused) multiple times.

[0124] By configuring the needle hub 38 and the light source unit 20 as an integrated unit, the needle hub 38 and the light source unit 20 can be made into disposable items that are discarded after a single use.

[0125] Since the light guide member 22 is formed hollow, the inside of the light guide member 22 can be used as the blood introduction channel 50 .

[0126] Because the light-guiding member 22 is an optical fiber, it can effectively guide the light L1 emitted by the light source unit 20. In this case, for example, by using an optical fiber for ambient lighting used in vehicles as the light-guiding member 22, it is possible to more effectively guide the light L1. Alternatively, by employing a general optical fiber as the light-guiding member 22 and forming a light emitting portion 88 by providing a hole in the side surface of the optical fiber, it is possible to more effectively guide the light L1.

[0127] Since the vascular puncture system 10 is equipped with a vascular puncture device 12, a light receiving unit 102, and an image display unit 104, it is possible to easily confirm whether or not the tip 25 of the catheter shaft 24 has been inserted into the blood vessel 302, even if the light L2 emitted from the light emitting unit 88 is of a wavelength that is difficult or impossible to see with the naked eye.

[0128] Next, a second embodiment will be described with reference to Fig. 14. In the second embodiment, the same components as those in the first embodiment (see Figs. 1 to 13) are denoted by the same reference numerals, and detailed description thereof will be omitted.

[0129] In the second embodiment, the blood vessel puncturing device 200 includes a catheter member 16, a light guiding member 22, a needle member 202, a light source unit 204, and a blood flow blocking unit 206. In the blood vessel puncturing device 200, the catheter member 16, the light guiding member 22, the needle member 202, and the blood flow blocking unit 206 are disposable items that are discarded after a single use. The light source unit 204 is a reusable item that can be used multiple times.

[0130] The needle member 202 includes a needle body 36 and a needle hub 208 .

[0131] The needle hub 208 has the needle connection hole 56, the lumen 58, and the mounting portion 210. The mounting portion 210, like the mounting portion 60 (see FIG. 3 ), is a recess (hole) that opens on the proximal end surface of the needle hub 208 and communicates with the lumen 58 of the needle hub 208.

[0132] The blood flow blocking unit 206 includes a support portion 212 and a filter 64. The support portion 212 is hollow. The support portion 212 supports the filter 64 disposed therein. An engaging portion 214 that engages with the mounting portion 210 is provided at the tip of the support portion 212. The engaging portion 214 is a convex portion that fits into the mounting portion 210, which is a concave portion. However, the mounting portion 210 may be a convex portion, and the engaging portion 214 may be a concave portion. The support portion 212 is fixed to the needle hub 208. The support portion 212 may be molded integrally with the needle hub 208. At least one of the support portion 212 and the filter 64 is made of a material that is transmissive to light L1.

[0133] A blood flow path 216 is formed inside the support portion 212. The distal end of the blood flow path 216 opens to the distal end surface of the engagement portion 214. When the engagement portion 214 is attached to the attachment portion 210, the blood flow path 216 communicates with the lumen 58 of the needle hub 208. The proximal end of the light-guiding member 22 is inserted into the blood flow path 216. The blood flow path 216 communicates with the lumen 46 (see FIG. 3 ) of the light-guiding member 22. The lumen 58 of the needle hub 208 and the blood flow path 216 form a blood inlet portion 218 for checking flashback, into which blood flowing in from the needle opening 44 of the needle body 36 is guided. Note that, because blood is guided from the proximal end opening of the lumen 46 to the blood inlet portion 218, in the second embodiment, the light-guiding member 22 does not need to include a communication hole 52 (see FIGS. 2 and 3 ). The filter 64 is disposed so as to block the blood flow path 216 from the proximal end direction.

[0134] A mounting portion 220 for mounting the light source unit 204 is provided on the support portion 212 closer to the base end than the filter 64. The mounting portion 220 is a recess (hole) that opens on the base end surface of the support portion 212. The mounting portion 220 is located on the axis of the needle body 36.

[0135] The light source unit 204 is formed to be detachable from the mounting portion 220. The light source unit 204 has a light source portion 74, a power supply portion 76, and a housing 222. The housing 222 has a housing main body 80 and a connecting portion 224. The connecting portion 224 is a convex portion that can fit into the mounting portion 220, which is a concave portion. A light guide hole 226 that communicates with the accommodation space 84 is formed in the connecting portion 224. The light guide hole 226 opens at the tip surface of the connecting portion 224. Light L1 emitted from the light source portion 74 is transmitted through the filter 64 and supplied to the light-guiding member 22. Alternatively, light L1 emitted from the light source portion 74 is transmitted through the support portion 212 and supplied to the light-guiding member 22.

[0136] In the second embodiment, after use of the blood vessel puncture device 200, the catheter member 16, the needle member 202, the blood flow preventing portion 206, and the light guiding member 22 can be disposed of together as disposable items when the light source unit 204 is detached from the needle hub 208. Furthermore, because the light source unit 204 is detachable from the blood flow preventing portion 206, exposure of the light source unit 204 to blood can be efficiently reduced.

[0137] The second embodiment has the following advantages.

[0138] A blood flow blocking portion 206 having an attachment portion 220 is provided at the proximal end of the needle hub 208. The light source unit 204 is detachable from the attachment portion 220 of the blood flow blocking portion 206. The blood flow blocking portion 206 blocks blood that has flowed into the needle hub 208 from flowing to the light source unit 204. This prevents the light source unit 204 from coming into contact with blood. Furthermore, because the light source unit 204 is detachable from the blood flow blocking portion 206, the light source unit 204 can be made into a reusable product that can be used (reused) multiple times.

[0139] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. A blood vessel puncture device comprising: a tubular catheter shaft; a catheter hub provided at a base end of the catheter shaft; a tubular needle body inserted into the catheter shaft and the catheter hub and capable of puncturing a blood vessel at a living body site; a needle hub provided at a base end of the needle body; a light guiding member inserted into an inner cavity of the needle body; and a light source unit that supplies light to the light guiding member, wherein a tip end of the catheter shaft has a catheter opening that communicates with the inner cavity of the catheter shaft, a tip end of the needle body has a blade surface and a needle opening formed on the blade surface that communicates with the inner cavity of the needle body and protrudes in a distal direction from the catheter opening, the light guiding member guides the light emitted by the light source unit, the tip end of the light guiding member is located on the base end side of the needle opening, and an outer surface of the tip end of the light guiding member has a light emitting portion that emits the light radially outward from the light guiding member, a wall of the needle body closer to the base end than the blade surface, the wall of the needle body having an inner light-transmitting portion facing the light emitting portion and capable of transmitting the light; a wall of the tip of the catheter shaft having an outer light-transmitting portion facing the inner light-transmitting portion and capable of transmitting the light; and a liquid-tight structure is provided between the outer surface of the tip of the light-guiding member and an inner surface of the needle body to prevent blood from flowing between the light emitting portion and the inner light-transmitting portion.

2. A blood vessel puncture device as claimed in claim 1, wherein the liquid-tight structure is formed by liquid-tight contact between the outer surface of the tip of the light-guiding member and the inner surface of the needle body.

3. A blood vessel puncture device according to claim 1 or 2, wherein the inner light-transmitting portion has a light-transmitting hole penetrating the wall portion of the needle body.

4. A blood vessel puncture device as described in claim 3, wherein the inner light-transmitting portion has a plurality of the light-transmitting holes, and the plurality of light-transmitting holes are spaced apart in the axial direction of the needle body in the wall portion of the needle body.

5. A blood vessel puncture device according to claim 1 or 2, wherein a light quantity suppression section is provided between the tip surface of the light guiding member and the needle opening for suppressing the quantity of light emitted from the tip surface of the light guiding member to the needle opening.

6. A blood vessel puncture device as claimed in claim 1 or 2, wherein the needle body or the light guiding member is provided with a blood introduction passage for guiding the blood to the needle hub, and the needle hub is provided with a blood inlet section for confirming flashback, into which the blood introduced from the blood introduction passage flows.

7. A blood vessel puncture device according to claim 1 or 2, wherein the needle hub has a mounting portion at its proximal end, and the light source unit is detachably attached to the mounting portion of the needle hub.

8. A blood vessel puncture device according to claim 1 or 2, wherein the needle hub and the light source unit are integrally constructed.

9. A vascular puncture device as claimed in claim 1 or 2, wherein the needle body or the light guiding member is provided with a blood introduction passage for guiding the blood to the needle hub, the vascular puncture device further comprises a blood flow blocking section provided at the base end of the needle hub and having an attachment section, the light source unit is detachable from the attachment section of the blood flow blocking section, and the blood flow blocking section prevents the blood that has flowed into the needle hub from flowing to the light source unit.

10. A blood vessel puncture device according to claim 1 or 2, wherein the light-guiding member is hollow.

11. A blood vessel puncture device according to claim 1 or 2, wherein the light-guiding member is an optical fiber.

12. A blood vessel puncture system comprising: a blood vessel puncture device as claimed in claim 1 or 2; a light receiving unit that receives the light emitted from the light emitting unit; and an image display unit that displays a received light image created based on the light received by the light receiving unit.

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