WO2024070898A1

WO2024070898A1 - Blood vessel piercing device and blood vessel piercing system

Info

Publication number: WO2024070898A1
Application number: PCT/JP2023/034346
Authority: WO
Inventors: 妻木翔太; 横田崇之
Original assignee: テルモ株式会社
Priority date: 2022-09-27
Filing date: 2023-09-21
Publication date: 2024-04-04

Abstract

A blood vessel piercing device (12) of a blood vessel piercing system (10) is provided with: a blood circulation blocking part (20); a light source unit (22); and an optical path (26). Light (L1) emitted from a light source (66) is guided outside from the leading end of a linear part (24). A blood inlet (62) for flashback confirmation to which blood flowing in through a leading end opening (46) of a needle body (38) is introduced is provided to at least one of a needle hub (40) and the blood circulation blocking part (20). The blood circulation blocking part (20) is formed so as to block circulation of blood to a fitting part (64).

Description

Vascular puncture device and vascular puncture system

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

For example, WO 2022/176880 discloses a blood vessel puncture device equipped with a linear portion (needle body and catheter shaft) capable of puncturing a blood vessel in a living body. The blood vessel puncture device includes a needle hub provided at the base end of the needle body, and a light source unit detachably provided at the base end of the needle hub. With the light source unit attached to the base end of the needle hub, the base end of the needle body is connected to the light source unit. An obstruction member that prevents blood from flowing into the light source unit is provided in the inner cavity of the needle body. Light emitted by the light source portion of the light source unit passes through the obstruction member and is guided out from the tip opening of the needle body.

In such a blood vessel puncture device, the light emitted from the tip opening of the needle body is absorbed or attenuated by the blood, so the intensity of the light received or visible outside the body part changes before and after the needle body secures the blood vessel. Therefore, it is possible to easily and quickly know whether the needle body has secured the blood vessel based on the light emitted by the light source unit.

Incidentally, when inserting a linear portion into a thick blood vessel or a blood vessel close to the skin, it may be possible to easily determine whether the blood vessel has been secured in the linear portion without relying on the light emitted by the light source unit. If the light source unit is detachable from the needle hub as in the above-mentioned International Publication No. 2022/176880, it is convenient to be able to select whether or not to use the light source unit depending on the situation. In addition, the light source unit, which is relatively expensive, can be reused, reducing the cost of the device for performing the blood vessel puncture procedure.

On the other hand, in the above-mentioned WO 2022/176880, the inner cavity of the needle body is blocked by a blocking member. In other words, the needle hub does not have a blood inlet portion (blood inlet portion for checking flashback) for confirming that the needle body has secured a blood vessel. When using a needle hub having a blood inlet portion for checking flashback, there is a problem that blood flowing into the blood inlet portion may come into contact with the light source unit, and the light source unit that has come into contact with blood cannot be reused.

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

(1) One aspect of the present invention is a blood vessel puncture device having a linear part capable of puncturing a blood vessel at a living body part, the linear part including a tubular needle body, and a needle hub provided at the base end of the needle body, the blood vessel puncture device comprising a blood flow blocking part provided at the base end of the needle hub, a light source unit having a light source part that emits light and is detachable to an attachment part of the blood flow blocking part, and an optical path that guides the light emitted by the light source part to the tip end of the linear part, the light emitted by the light source part is guided to the outside from the tip end of the linear part, at least one of the needle hub and the blood flow blocking part is provided with a blood inflow part for checking flashback, through which blood flowing in from the tip opening of the needle body is guided, and the blood flow blocking part is formed so as to prevent the blood from flowing to the attachment part.

(2) In the blood vessel puncture device described in item (1), when the light source unit is attached to the attachment portion, the light source portion may emit the light toward the tip of the linear portion.

(3) In the blood vessel puncture device described in item (1) or (2), the light source unit may have a housing that houses the light source section, and the housing may have a connection section that is detachable from the attachment section.

(4) In the blood vessel puncture device described in any one of items (1) to (3), the blood flow blocking portion may be fixed to the base end of the needle hub.

(5) In the blood vessel puncture device described in any one of items (1) to (3), the blood flow blocking portion may be detachable from the base end of the needle hub.

(6) In the blood vessel puncture device described in any one of items (1) to (5), the light emitted by the light source unit may be guided out from the tip opening of the needle body through the inner cavity of the needle body.

(7) In the blood vessel puncture device described in item (6), the inner surface of the needle body may be provided with a reflecting portion that reflects the light emitted by the light source unit.

(8) In the blood vessel puncture device described in item (6), the optical path may include a light-guiding member for guiding the light emitted by the light source unit to the tip of the needle body.

(9) In the blood vessel puncture device described in item (8), the tip of the light-guiding member may be positioned at the tip of the needle body when inserted into the inner cavity of the needle body.

(10) In the blood vessel puncture device described in item (8) or (9), the base end of the light-guiding member may be supported by the blood flow blocking portion.

(11) In the blood vessel puncture device described in item (10), the blood flow blocking section is detachable from the base end of the needle hub, and the inner surface of the needle hub is provided with a guide surface for guiding the light guiding member into the inner cavity of the needle body when the blood flow blocking section is attached to the base end of the needle hub, and the guide surface may taper in diameter toward the needle body.

(12) In the blood vessel puncture device described in any one of items (1) to (11), the blood flow blocking section includes a filter that blocks the flow of blood from the blood inlet section to the attachment section, and a support section that supports the filter, and the attachment section may be provided at the base end of the support section.

(13) In the vascular puncture device described in any one of items (1) to (12), the light source unit may emit light that includes near-infrared light.

(14) A blood vessel puncture device according to any one of items (1) to (13), comprising a tubular catheter shaft having a lumen through which the needle body is inserted, and a catheter hub provided at the base end of the catheter shaft and having a lumen through which the needle body is inserted, and the linear portion may include the needle body and the catheter shaft.

(15) In the blood vessel puncture device described in item (14), the optical path may be provided in the wall of the blood flow blocking portion, the wall of the needle hub, the wall of the catheter hub, and the wall of the catheter shaft, and the light emitted by the light source may be guided to the outside from the tip of the catheter shaft.

(16) In the blood vessel puncture device described in item (15), a light transmission suppression section that suppresses the transmission of the light emitted by the light source section may be provided on the outer peripheral surface of each of the wall section of the blood flow blocking section, the wall section of the needle hub, the wall section of the catheter hub, and the wall section of the catheter shaft.

(17) In the blood vessel puncture device described in item (10), the blood flow blocking portion may be movable along the axial direction of the needle body while being liquid-tightly attached to the base end of the needle hub.

(18) In the blood vessel puncture device described in item (17), the base end of the needle hub may be provided with a female thread portion, and the tip end of the blood flow blocking portion may be provided with a male thread portion that screws into the female thread portion.

(19) In the vascular puncture device described in item (18), the male threaded portion may be in liquid-tight contact with the female threaded portion.

(20) Another aspect of the present invention is a blood vessel puncture system comprising a blood vessel puncture device according to any one of items (1) to (19), a light receiving unit that receives the light emitted from the tip of the linear portion, and an image display unit that displays a received light image created based on the light received by the light receiving unit.

According to the present invention, since the light source unit is detachable from the attachment part of the blood flow blocking part, it is possible to select whether or not to use the light source unit depending on the situation. Furthermore, when the light source unit is used, the light emitted by the light source unit is guided to the tip of the linear part via the optical path. When the linear part is in a state before the blood vessel is secured, the light derived from the tip of the linear part passes through the biological tissue (subcutaneous tissue other than the blood vessel, etc.) and is guided to the outside of the biological part. On the other hand, when the blood vessel is secured by the linear part, the light derived from the tip of the linear part is absorbed by the blood or attenuated when passing through the blood. In other words, the intensity of the light received or visible outside the biological part changes before and after the blood vessel is secured by the linear part, so it is possible to easily and quickly know whether the blood vessel is secured by the linear part based on the light emitted by the light source part.

Furthermore, because blood flows into the blood inlet section when the needle body secures a blood vessel, the user can accurately tell whether the needle body has secured a blood vessel by visually checking the blood flow into the blood inlet section. At this time, the blood flow to the attachment section is blocked by the blood flow blocking section. Therefore, the light source unit attached to the attachment section does not come into contact with blood. Therefore, the light source unit can be reused.

FIG. 1 is a schematic diagram of a blood vessel puncture system according to one embodiment of the present invention. 2 is an exploded perspective view of the vascular puncture device of FIG. 1. FIG. FIG. 3 is a longitudinal cross-sectional view of the vascular puncture device of FIG. FIG. 4 is a first explanatory diagram of a procedure for puncturing a blood vessel using the blood vessel puncture device of FIG. FIG. 5 is a second explanatory diagram of the puncture procedure. FIG. 6 is an explanatory diagram showing a received light image in the state shown in FIG. FIG. 7 is a third explanatory diagram of the puncture procedure. FIG. 8 is an explanatory diagram showing a received light image in the state shown in FIG. FIG. 9 is a fourth explanatory diagram of the puncture procedure. FIG. 10 is a fifth explanatory diagram of the puncture procedure. Fig. 11A is a partially omitted longitudinal sectional view of a blood vessel puncture device including a light source unit according to a first configuration example, and Fig. 11B is an explanatory diagram of a state in which the light source unit shown in Fig. 11A is attached to a mounting portion. FIG. 12 is a longitudinal sectional view, with a portion thereof omitted, of a blood vessel puncture device including a light source unit according to the second configuration example. FIG. 13 is a longitudinal sectional view of a blood vessel puncture device according to a first modified example. Figure 14A is a first explanatory view of a procedure for using the vascular puncture device of Figure 13. Figure 14B is a second explanatory view of the procedure for using the device. 15A and 15B are third and fourth explanatory views of the usage procedure. FIG. 16 is a longitudinal sectional view of a blood vessel puncture device according to a second modified example. FIG. 17 is an explanatory diagram showing a received light image of the blood vessel puncture device of FIG. 16 in a state before the blood vessel is secured. FIG. 18 is a cross-sectional view illustrating a blood flow blocking portion according to an example of the configuration. FIG. 19 is a longitudinal sectional view of a blood vessel puncture device according to a third modified example. FIG. 20 is a longitudinal sectional view of a blood vessel puncture device according to a fourth modified example. FIG. 21 is a longitudinal sectional view of a blood vessel puncture device according to a fifth modified example.

As shown in FIG. 1, a vascular puncture system 10 according to one embodiment of the present invention includes a vascular puncture device 12 and a visualization device 14. The vascular puncture device 12 is configured as an indwelling needle (peripheral arterial and venous indwelling needle, dialysis indwelling needle, etc.) for administering an infusion (medicinal solution) into a blood vessel 302 of a living body part 300 (see FIG. 7). However, 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. The vascular puncture device 12 may also be a blood collection needle without a catheter.

As shown in Figures 1 to 3, the vascular puncture device 12 comprises a catheter member 16, a needle member 18, a blood flow blocking portion 20, and a light source unit 22. The catheter member 16, the needle member 18, and the blood flow blocking portion 20 are disposable items that are discarded after a single use. The light source unit 22 is a reusable item that can be used multiple times.

In its initial state, the vascular puncture device 12 has a linear portion 24 capable of puncturing a blood vessel 302 in a biological site 300. In FIG. 3, the linear portion 24 is formed by inserting the tubular needle body 38 of the needle member 18 into the lumen 32 of the tubular catheter shaft 28 of the catheter member 16. In other words, the linear portion 24 has a double tube structure. The vascular puncture device 12 has an optical path 26 that guides light L1 emitted by the light source portion 66 of the light source unit 22 located at the base end of the vascular puncture device 12 to the tip of the linear portion 24.

As shown in Figures 2 and 3, the catheter member 16 has a flexible catheter shaft 28 and a catheter hub 30 provided at the base end of the catheter shaft 28. The catheter shaft 28 is a tubular member that can be continuously inserted into a blood vessel 302 of a biological site 300. The catheter shaft 28 has an inner lumen 32 (medicinal solution supply path) that extends axially over its entire length. A tip opening 34 that communicates with the inner lumen 32 is formed at the tip of the catheter shaft 28.

Examples of materials that can be used to make the catheter shaft 28 include fluororesins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA), olefin resins such as polyethylene and polypropylene, or mixtures of these, polyurethane, polyester, polyamide, polyether nylon resin, and mixtures of olefin resins and ethylene-vinyl acetate copolymers.

The wall of the catheter shaft 28 forms part of the light path 26. The wall of the catheter shaft 28 guides the light L1 emitted by the light source unit 66 from the base end of the catheter shaft 28 to the tip end 35. At least the part of the catheter shaft 28 that forms the light path 26 is transparent so that the light L1 emitted by the light source unit 66 can pass through.

The catheter shaft 28 may be entirely transparent. The material constituting at least the portion of the catheter shaft 28 that forms the optical path 26 may include, for example, methacrylic resin. The portion of the catheter shaft 28 that forms the optical path 26 may be hollow.

In FIG. 3, the catheter hub 30 is formed in a hollow (cylindrical) shape. The base end of the catheter shaft 28 is fixed to the tip of the catheter hub 30. The catheter hub 30 is preferably made of a material harder than the catheter shaft 28. The material of the catheter hub 30 is not particularly limited, but examples of suitable materials that can be used 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) is provided in the inner cavity 36 of the catheter hub 30.

The wall of the catheter hub 30 forms part of the light path 26. The wall of the catheter hub 30 guides the light L1 emitted by the light source unit 66 from the base end to the tip end of the catheter hub 30. At least the portion of the catheter hub 30 that forms the light path 26 is transparent so that the light L1 emitted by the light source unit 66 can pass through. The entire catheter hub 30 may be transparent.

The material constituting at least the portion of the catheter hub 30 that forms the optical path 26 may include, for example, methacrylic resin. The portion of the catheter hub 30 that forms the optical path 26 may be hollow. A light-guiding member (e.g., optical fiber, acrylic member, glass member, light-emitting tube, etc.) that forms the optical path 26 may be embedded in the wall of the catheter hub 30. In this case, the light-guiding member may be provided continuously from the base end to the tip end of the catheter hub 30, or may be provided intermittently.

2 and 3, the needle member 18 comprises a needle body 38 and a needle hub 40 provided at the base end of the needle body 38. The needle body 38 is a tubular member having sufficient rigidity to puncture a biological site 300 (see FIGS. 5 and 7). The needle body 38 is formed in a cylindrical shape. In FIG. 3, the needle body 38 has an inner cavity 42 extending along the axial direction. The needle body 38 is inserted into the inner cavity 32 of the catheter shaft 28 and the inner cavity 36 of the catheter hub 30 in the initial state (assembled state) of the vascular puncture device 12.

The needle body 38 is made of a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy. The needle body 38 may also be made of a resin material such as polypropylene (PP), polycarbonate (PC), polyether ether ketone (PEEK), or liquid crystal polymer (LCP). The needle body 38 is formed to be sufficiently long compared to the catheter shaft 28, and protrudes from the tip opening 34 of the catheter shaft 28 in the initial state of the vascular puncture device 12.

A blade surface 44 is formed at the tip of the needle body 38, which is inclined relative to the axis of the needle body 38. A tip opening 46 that communicates with the inner cavity 42 of the needle body 38 is formed on the blade surface 44.

As shown in FIG. 3, the needle hub 40 is formed to be hollow (cylindrical). The tip of the needle hub 40 is provided with a needle connection hole 48 into which the base end of the needle 38 is inserted. The base end of the needle hub 40 is provided with a first engagement portion 50. The first engagement portion 50 is a recess (hole) that opens into the base end surface of the needle hub 40.

The needle hub 40 has an inner cavity 52 that communicates with the inner cavity 42 of the needle body 38. Blood that has flowed through the inner cavity 42 of the needle body 38 flows into the inner cavity 52 of the needle hub 40. The needle hub 40 can be made of the same materials as those of the catheter hub 30 described above.

The wall of the needle hub 40 forms part of the light path 26. The wall of the needle hub 40 guides the light L1 emitted by the light source unit 66 from the base end to the tip end of the needle hub 40. At least the part of the needle hub 40 that forms the light path 26 is transparent so that the light L1 emitted by the light source unit 66 can pass through. The entire needle hub 40 may be transparent.

The material of at least the portion of the needle hub 40 that forms the light path 26 may include, for example, methacrylic resin. The portion of the needle hub 40 that forms the light path 26 may be hollow. A light-guiding member (e.g., optical fiber, acrylic member, glass member, light-emitting tube, etc.) that forms the light path 26 may be embedded in the wall of the needle hub 40. In this case, the light-guiding member may be provided continuously from the base end to the tip end of the needle hub 40, or may be provided intermittently.

The blood flow blocking section 20 has a support section 54 and a filter 56 supported by the support section 54. The support section 54 is formed hollow. The support section 54 supports the filter 56 arranged inside the support section 54. A second engagement section 58 that engages with the first engagement section 50 is provided at the tip of the support section 54. The second engagement section 58 is a convex section that fits into the first engagement section 50, which is a concave section. However, the first engagement section 50 may be a convex section and the second engagement section 58 may be a concave section. The support section 54 is fixed to the needle hub 40. The support section 54 may be molded integrally with the needle hub 40.

The support portion 54 has a blood flow path 60 that communicates with the inner cavity 52 of the needle hub 40. Blood in the inner cavity 52 of the needle hub 40 flows through the blood flow path 60. The inner cavity 52 of the needle hub 40 and the blood flow path 60 form a blood inlet portion 62 for checking flashback, into which blood that has flowed in from the tip opening 46 of the needle body 38 is guided. The blood flow path 60 extends along the axial direction of the needle body 38. The blood flow path 60 is located on an extension of the axis of the needle body 38.

A mounting portion 64 for mounting the light source unit 22 is provided on the support portion 54 in the proximal direction from the filter 56. The mounting portion 64 is a recess (hole) that opens into the proximal end surface of the support portion 54. The mounting portion 64 is located on the axis of the needle body 38.

The wall of the support portion 54 forms part of the light path 26. The wall of the support portion 54 guides the light L1 emitted by the light source portion 66 from the base end to the tip end of the support portion 54. At least the portion of the support portion 54 that forms the light path 26 is transparent so that the light L1 emitted by the light source portion 66 can pass through. The entire support portion 54 may be transparent.

The constituent material of at least the portion of the support 54 that forms the light path 26 may include, for example, methacrylic resin. The portion of the support 54 that forms the light path 26 may be hollow. A light-guiding member (e.g., optical fiber, acrylic member, glass member, light-emitting tube, etc.) that forms the light path 26 may be embedded in the wall of the support 54. In this case, the light-guiding member may be provided continuously from the base end to the tip end of the support 54, or may be provided intermittently.

The filter 56 is positioned so as to block the blood flow path 60 from the proximal direction. The filter 56 allows air to flow while blocking blood flow. In other words, the filter 56 blocks blood flowing through the blood flow path 60 from flowing into the attachment part 64. The filter 56 is preferably made of a material that transmits the light L1 emitted by the light source part 66.

One or more air vent holes (not shown) are formed in the support section 54 proximal to the filter 56 to allow blood to flow smoothly into the blood inlet section 62. Note that one or more air vent holes for discharging air from within the blood inlet section 62 to the outside may be provided in the needle hub 40. In this case, a filter 56 is provided in the air vent hole to prevent blood from flowing out.

The light source unit 22 is formed so as to be detachable from the mounting portion 64. When the light source unit 22 is mounted on the mounting portion 64, the outer surface of the light source unit 22 is flush with the outer surface of the blood flow blocking portion 20. In other words, the outer surface of the light source unit 22 does not have a protrusion that protrudes outward beyond the outer surface of the blood flow blocking portion 20 when the light source unit 22 is mounted on the mounting portion 64. In this case, it is possible to prevent the light source unit 22 from hitting the living body when the needle body 38 is inserted into the blood vessel 302. Note that when the light source unit 22 is mounted on the mounting portion 64, the outer surface of the light source unit 22 may be located radially inward (inner) than the outer surface of the blood flow blocking portion 20.

The light source unit 22 has a light source section 66, a power supply section 68, and a housing 70. The light source section 66 is housed in the housing 70. As the light source section 66, for example, an LED, a lamp (e.g., a halogen lamp), a laser irradiation unit (e.g., a laser diode), etc. can be used.

The light source unit 66 emits light L1 in a wavelength range that is easily absorbed by hemoglobin in blood and easily transmits through subcutaneous tissue. Specifically, the light source unit 66 emits at least one of visible light and near-infrared light. The wavelength of visible light is preferably 600 nm or more and less than 700 nm. The wavelength of 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.

The light L1 emitted by the light source unit 66 has a peak wavelength of 600 nm or more and 2500 nm or less. The light source unit 66 may simultaneously emit light L1 of multiple wavelengths. That is, the light source unit 66 may simultaneously emit, for example, visible light of 600 nm and near-infrared light of 850 nm. The light source unit 66 is capable of adjusting the brightness of the light L1. The light source unit 66 may be lit continuously or may flash.

The power supply unit 68 is provided in the housing 70. The power supply unit 68 supplies power to the light source unit 66. The power supply unit 68 includes, for example, a battery. Examples of the battery include a primary battery, a secondary battery, a solar cell, etc. The power supply unit 68 may include a wireless power supply device, or may include a plug that can be connected to a wiring socket connector (outlet). The power supply unit 68 is provided at the base end of the housing 70. The power supply unit 68 may be housed within the housing 70.

The housing 70 is formed, for example, in a tubular (e.g., cylindrical) shape. The housing 70 has a housing main body 74 in which an accommodating space 72 for the light source unit 66 is formed, and a connecting portion 76 that protrudes from the housing main body 74 and is detachable from the mounting portion 64. To prevent the light L1 emitted by the light source unit 66 from leaking to the outside, a portion of the housing main body 74 is formed from a material that is opaque to the light L1. Alternatively, a portion of the housing main body 74 (the outer peripheral surface or the inner peripheral surface) is coated with a material that is opaque to the light L1.

The connection part 76 is a convex part that can be fitted into the mounting part 64, which is a concave part. A light guide hole 78 that communicates with the storage space 72 is formed in the connection part 76. The light guide hole 78 opens at the tip surface of the connection part 76. The connection part 76 may be formed solid. In this case, the connection part 76 has transparency so that the light L1 emitted by the light source part 66 can pass through.

The connection part 76 and the attachment part 64 preferably have smooth surfaces without any irregularities so that they can be easily wiped with alcohol. When the connection part 76 is attached to the attachment part 64, the light source part 66 is located on an extension of the axis of the needle body 38. When the connection part 76 is attached to the attachment part 64, the light source part 66 emits light L1 toward the tip of the needle body 38.

The mounting structure of the blood flow blocking portion 20 and the light source unit 22 may be such that the mounting portion 64 is a convex portion and the connection portion 76 is a concave portion (hole portion). In addition, the mounting structure is not limited to a fitting structure using convex and concave portions, but may be a claw engagement structure, a magnetic attraction structure, a hook-and-loop fastener engagement structure, a screw-threaded structure, etc.

The vascular puncture device 12 has a light transmission suppression section 80 for suppressing leakage of light L1 emitted by the light source section 66 to the outside when the light L1 is guided to the tip section 35 of the catheter shaft 28. The light transmission suppression section 80 is provided on the outer surface of each of the catheter shaft 28, the catheter hub 30, the needle hub 40, and the blood flow blocking section 20.

The light transmission suppression section 80 is provided from a position shifted from the tip of the catheter shaft 28 in the proximal direction by a predetermined length to the tip of the catheter hub 30. In other words, the light transmission suppression section 80 is not provided at the tip 35 of the catheter shaft 28. That is, the light L1 emitted by the light source section 66 is guided to the outside from the tip 35 of the catheter shaft 28. The tip 35 of the catheter shaft 28 may contain a fluorescent material that emits near-infrared light when irradiated with the light L1 emitted by the light source section 66. The tip 35 of the catheter shaft 28 may also contain a phosphorescent material that emits near-infrared light. The tip 35 of the catheter shaft 28 may be a film that can convert near-infrared light into visible light. In this case, only the tip 35 can be made to emit light without the catheter hub 30 and the needle hub 40 emitting visible light, making it easier to visually recognize the tip 35.

The light transmission suppression section 80 is provided, for example, on the outer peripheral surfaces of the catheter hub 30, the needle hub 40, and the support section 54. Note that the needle hub 40 and the support section 54 have portions on their outer surfaces where the light transmission suppression section 80 is not provided, so that the blood inlet section 62 can be seen from the outside.

The light transmission suppression section 80 is formed, for example, by painting a light-opaque material such as carbon black onto the target surface. The light transmission suppression section 80 may also be formed, for example, by evaporating or coating a metal film onto the target surface.

As shown in FIG. 1, the visualization device 14 includes an irradiation unit 82, a light receiving unit 84, and an image display unit 86. The irradiation unit 82 irradiates light L2 to a biological site 300 (object to be visualized) punctured by the vascular puncture device 12. The irradiation unit 82 has an irradiation unit main body 88 that emits light L2. The irradiation unit main body 88 emits near-infrared light as light L2. The wavelength of the near-infrared light emitted by the irradiation unit main body 88 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. The wavelengths of light L1 and light L2 may be the same or different.

The light receiving unit 84 is disposed on the opposite side of the body part 300 from the irradiation unit 82. In other words, the irradiation unit 82 and the light receiving unit 84 are disposed so as to face each other with the body part 300 in between. The light receiving unit 84 is a camera (imaging unit) for receiving the light L1 emitted by the light source unit 66 and the light L2 emitted by the irradiation unit 82. For example, a CCD camera for near-infrared light is used as the light receiving unit 84. The light receiving unit 84 may also be a film capable of converting near-infrared light into visible light.

The image display unit 86 displays an image (received light image 90) created based on the light L1 and L2 received by the light receiving unit 84. The image display unit 86 may be goggles that can be worn or removed by a person, a fixed display, or a projector.

In the visualization device 14, the irradiation unit 82 may be arranged on the side of the biological part 300 where the light receiving unit 84 is located. In this case, the light receiving unit 84 receives the light L2 emitted by the irradiation unit 82 that is reflected by the biological part 300 (reflected light). In addition, in the visualization device 14, the irradiation unit 82 may be arranged on both the opposite side of the biological part 300 to the light receiving unit 84 and the side of the biological part 300 where the light receiving unit 84 is located. In this case, both the light L2 emitted by each irradiation unit 82 that is transmitted through the biological part 300 (transmitted light) and the light reflected by the biological part 300 (reflected light) are received by the light receiving unit 84.

Next, an example of a procedure for puncturing a blood vessel 302 using the blood vessel puncture device 12 will be described.

As shown in FIG. 3, in the initial state of the vascular puncture device 12, the blade surface 44 faces upward and protrudes from the tip opening 34 of the catheter shaft 28 toward the tip. The light source unit 22 is not attached to the blood flow blocking section 20. Here, the case where the light source section 66 emits light L1 including near-infrared light will be described.

First, the user determines whether the light source unit 22 is necessary based on the patient's blood vessel 302 to be punctured. Specifically, if the user determines that the blood vessel 302 to be punctured is easy to grasp from the outside (easy to determine whether the blood vessel is secured) and the light source unit 22 is unnecessary, the user performs the puncture operation of the linear portion 24 (needle body 38 and catheter shaft 28) into the blood vessel 302 without attaching the light source unit 22 to the blood flow blocking portion 20.

On the other hand, if the user determines that the blood vessel 302 to be punctured is difficult to grasp from the outside (difficult to determine whether the blood vessel is secured) and therefore the light source unit 22 is necessary, the user attaches the connection portion 76 of the light source unit 22 to the attachment portion 64 of the blood flow blocking portion 20, as shown in FIG. 4.

Then, the user sets up the visualization device 14. Specifically, as shown in FIG. 5, the irradiation unit 82 is placed below the biological part 300 (e.g., the forearm of a human body) and the light receiving unit 84 is placed above the biological part 300. Then, the irradiation unit 82 irradiates the biological part 300 with light L2 and the tip of the linear part 24 is inserted into the biological part 300 (at a position closer to the blood vessel 302).

The light L2 emitted by the irradiation unit 82 then passes through the biological tissue 304 (e.g., skin tissue and muscle tissue) other than the blood vessels 302 of the biological part 300 while being scattered, and the transmitted light L2 (transmitted light) is received by the light receiving unit 84. At this time, the hemoglobin in the blood flowing through the blood vessels 302 absorbs the light L2. Furthermore, the light L2 does not pass through the needle body 38.

Light L1 emitted by the light source unit 66 is guided out from the tip 35 of the catheter shaft 28 via the optical path 26 (light guide hole 78, support unit 54, needle hub 40, catheter hub 30, and catheter shaft 28). Light L1 guided out from the tip 35 of the catheter shaft 28 passes through the biological tissue 304 (e.g., skin tissue or muscle tissue) of the biological part 300 while being scattered, and the transmitted light L1 (transmitted light) is received by the light receiving unit 84.

As a result, as shown in FIG. 6, a received light image 90 created based on the light L1 and L2 received by the light receiving unit 84 is displayed on the image display unit 86. For example, the biological tissue 304, blood vessels 302, and the tip of the linear portion 24 are displayed on the received light image 90.

Specifically, in the received light image 90, the tip 35 of the catheter shaft 28 (the portion from which the light L1 is emitted) is displayed brightest (white), and the biological tissue 304 is displayed darker than the tip 35 of the catheter shaft 28. Also, in the received light image 90, the blood vessel 302 and the needle body 38 are displayed darker than the biological tissue 304. Note that when the needle body 38 is not inserted into the blood vessel 302, the brightness of the needle body 38 is equal to or greater than the brightness of the blood vessel 302. This allows the user to easily and clearly distinguish between the blood vessel 302 and the tip 35 of the catheter shaft 28 in the received light image 90.

Next, as shown in FIG. 7, when the tip opening 46 of the needle body 38 is inserted into the blood vessel 302, blood in the blood vessel 302 is guided from the tip opening 46 of the needle body 38 through the lumen 42 of the needle body 38 into the blood inlet section 62. At this time, air in the lumen 42 of the needle body 38 and the blood inlet section 62 passes through the filter 56 and is discharged from an air vent hole (not shown) of the blood flow blocking section 20. Therefore, the blood is smoothly guided into the blood inlet section 62 of the needle hub 40. Then, by visually checking the blood guided to the blood inlet section 62, the user can know that the tip opening 46 of the needle body 38 has been inserted into the blood vessel 302 (the blood vessel is secured by the needle body 38).

At this time, the flow of blood in the blood inlet 62 toward the proximal end is blocked by the filter 56. Therefore, the blood in the blood inlet 62 does not come into contact with the light source unit 22.

In addition, when the tip 35 of the catheter shaft 28 is inserted into the blood vessel 302, the light L1 emitted by the light source 66 is absorbed by the hemoglobin in the blood. As a result, the light L1 does not reach the light receiving unit 84, or even if it does reach the light receiving unit 84, its intensity is greatly reduced.

Therefore, as shown in FIG. 8, the appearance of the tip 35 of the catheter shaft 28 changes in the received light image 90 (the tip 35 of the catheter shaft 28 becomes darker). In other words, in the received light image 90, the brightness of the tip 35 of the catheter shaft 28 becomes equal to or lower than the brightness of the blood vessel 302. Also, in the received light image 90, the brightness of the needle body 38 is 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 90 that the tip 35 of the catheter shaft 28 has been inserted into the blood vessel 302 (the catheter shaft 28 has secured the blood vessel).

Then, as shown in FIG. 9, the user removes the needle member 18 from the catheter member 16 while leaving the tip 35 of the catheter shaft 28 in the blood vessel 302, and administers the medicinal liquid into the blood vessel 302 via the lumen 32 of the catheter shaft 28.

Furthermore, as shown in FIG. 10, the light source unit 22 is removed from the blood flow blocking portion 20. The light source unit 22 removed from the blood flow blocking portion 20 is reused. The used needle member 18 and the blood flow blocking portion 20 fixed to the needle hub 40 are discarded together.

In this embodiment, when the light source unit 66 emits only visible light, the user can recognize the light L1 emitted from the tip 35 of the catheter shaft 28 before the catheter shaft 28 secures the blood vessel. On the other hand, when the catheter shaft 28 secures the blood vessel, the light L1 is absorbed by hemoglobin in the blood, and the user cannot recognize the light L1 emitted from the tip 35 of the catheter shaft 28. Therefore, even when the light source unit 66 emits only visible light, the user can easily and quickly know that the linear portion 24 has secured the blood vessel based on the light L1 emitted by the light source unit 66.

This embodiment provides the following advantages:

In this embodiment, the light source unit 22 is detachable from the attachment portion 64 of the blood flow blocking portion 20, so it is possible to select whether or not to use the light source unit 22 depending on the situation. Furthermore, when the light source unit 22 is used, the light L1 emitted by the light source portion 66 is guided to the tip portion 35 of the catheter shaft 28 via the optical path 26.

Before the catheter shaft 28 secures the blood vessel, the light L1 emitted from the tip 35 of the catheter shaft 28 passes through the biological tissue 304 (subcutaneous tissue other than the blood vessel 302, etc.) and is guided to the outside of the biological part 300. On the other hand, when the catheter shaft 28 secures the blood vessel, the light L1 emitted from the tip 35 of the catheter shaft 28 is absorbed by the blood or attenuated as it passes through the blood. In other words, the intensity of the light L1 that can be received or seen outside the biological part 300 changes before and after the catheter shaft 28 secures the blood vessel, so that it is possible to easily and quickly know whether the catheter shaft 28 (linear part 24) has secured the blood vessel based on the light L1 emitted by the light source unit 66.

Furthermore, since blood flows into the blood inlet section 62 as the needle body 38 secures the blood vessel, the user can accurately know whether the needle body 38 has secured the blood vessel by visually checking the blood flow into the blood inlet section 62. At this time, the blood flow to the attachment section 64 is blocked by the blood flow blocking section 20. Therefore, the light source unit 22 attached to the attachment section 64 does not come into contact with blood. Therefore, the light source unit 22 can be reused.

When the light source unit 22 is attached to the attachment portion 64, the light source portion 66 emits light L1 toward the tip of the linear portion 24.

With this configuration, the light L1 emitted by the light source unit 66 can be easily guided to the tip of the linear portion 24 (the tip 35 of the catheter shaft 28).

The light source unit 22 has a housing 70 that houses the light source section 66, and the housing 70 has a connection section 76 that can be attached and detached to the attachment section 64.

With this configuration, the light source unit 66 can be protected by the housing 70.

The blood flow blocking section 20 is fixed to the base end of the needle hub 40.

This configuration can prevent blood from leaking between the needle hub 40 and the blood flow blocking portion 20.

The blood flow blocking section 20 includes a filter 56 that blocks blood flow from the blood inlet section 62 to the attachment section 64, and a support section 54 that supports the filter 56. The attachment section 64 is provided at the base end of the support section 54.

With this configuration, the filter 56 can effectively suppress the flow of blood from the blood inlet portion 62 to the attachment portion 64.

The light source unit 66 emits light L1 that includes near-infrared light.

This configuration effectively changes the appearance of the light L1 emitted by the light source unit 66 and guided out from the tip 35 of the catheter shaft 28 before and after the blood vessel is secured.

The light path 26 is provided in the wall of the blood flow blocking section 20, the wall of the needle hub 40, the wall of the catheter hub 30, and the wall of the catheter shaft 28. The light L1 emitted by the light source 66 is guided to the outside from the tip 35 of the catheter shaft 28.

With this configuration, it is possible to know whether the catheter shaft 28 has secured a blood vessel based on the light L1 emitted by the light source unit 66. In addition, with a simple configuration, the light L1 emitted by the light source unit 66 can be guided to the tip 35 of the catheter shaft 28.

A light transmission suppression section 80 that suppresses the transmission of light L1 emitted by the light source section 66 is provided on the outer peripheral surface of each of the walls of the blood flow blocking section 20, the needle hub 40, the catheter hub 30, and the catheter shaft 28.

With this configuration, the light L1 emitted by the light source unit 66 can be efficiently guided to the tip 35 of the catheter shaft 28.

The vascular puncture system 10 includes a light receiving unit 84 that receives light L1 emitted from the tip of the linear portion 24, and an image display unit 86 that displays a received light image 90 created based on the light L1 received by the light receiving unit 84.

With this configuration, it is possible to know whether the catheter shaft 28 has secured the blood vessel based on the received light image 90 displayed on the image display unit 86.

The vascular puncture device 12 may have a light source unit 22a shown in Figs. 11A and 11B instead of the light source unit 22 described above. As shown in Figs. 11A and 11B, the light source unit 22a includes a cover portion 100 provided on the housing main body 74. The cover portion 100 protrudes in the distal direction beyond the distal end of the housing 70. The cover portion 100 is formed, for example, in a cylindrical shape.

The cover section 100 is formed so as to prevent the light L1 emitted by the light source section 66 from passing through it. Specifically, the cover section 100 is made of an opaque material so as to prevent the light L1 emitted by the light source section 66 from passing through it. However, the cover section 100 may be made of a transparent material and formed by painting the surface with a light-opaque material such as carbon black. The cover section 100 may also be made of a transparent material and formed by evaporating or coating a metal film on the surface. The cover section 100 may be integrally molded with the housing main body 74, or may be formed as a separate member from the housing main body 74.

As shown in FIG. 11B, the cover portion 100 is provided on the housing main body 74 so as to cover from the outside the portion of the support portion 54 that forms the light path 26 when the light source unit 22a is attached to the blood flow blocking portion 20. In this case, the light transmission suppression portion 80 may not be provided on at least the portion of the light path 26 of the support portion 54 that is covered by the cover portion 100. The cover portion 100 may be provided on the housing main body 74 so as to cover from the outside the portion of the needle hub 40 that forms the light path 26 when the light source unit 22a is attached to the blood flow blocking portion 20.

The vascular puncture device 12 may have a light source unit 22b shown in FIG. 12 instead of the light source unit 22 described above. As shown in FIG. 12, the light source unit 22b includes a light source section 66, a power supply section 68, a housing 110, a light transmission section 112, and a connecting section 114. The housing 110 has an accommodation space 116 that accommodates the light source section 66. The power supply section 68 is provided in the housing 110.

The light transmission section 112 transmits the light L1 emitted by the light source section 66. The light transmission section 112 is, for example, an optical fiber. One end of the light transmission section 112 is attached to the housing 110. The other end of the light transmission section 112 is provided with a connecting section 114. The connecting section 114 has a connection section 118 that is detachable from the mounting section 64. The connection section 118 is configured in the same manner as the connection section 76 described above.

With this type of light source unit 22b, for example, the needle member 18 and catheter member 16 can be operated with the housing 110 and power supply unit 68 placed on the floor or the like. This makes it possible to prevent the needle member 18 from becoming difficult to operate even if the light source unit 66 and power supply unit 68 are made larger so that a sufficient amount of light L1 is guided to the tip 35 of the catheter shaft 28 (the tip of the linear portion 24).

(First Modification)
Next, the blood vessel puncturing device 12A according to the first modified example will be described. In the blood vessel puncturing device 12A, the same components as those described above are given the same reference numerals, and detailed description will be omitted. Note that in the blood vessel puncturing device 12A, the same components as those in the blood vessel puncturing device 12 described above have the same effects. The same applies to the blood vessel puncturing devices 12B to 12E according to the second to fifth modified examples described below.

As shown in FIG. 13, the blood vessel puncture device 12A according to the first modified example includes a catheter member 16, a needle member 18a, a blood flow blocking portion 20a, and a light source unit 22. The blood flow blocking portion 20a is detachable from the needle member 18a. In other words, the second engagement portion 58 is detachably fitted to the first engagement portion 50.

The mating force (connection force) between the first engaging portion 50 and the second engaging portion 58 is formed to be greater than the mating force (connection force) between the mounting portion 64 and the connection portion 76. In this case, when the light source unit 22 is pulled in the proximal direction relative to the needle hub 40, the light source unit 22 can be removed from the blood flow blocking portion 20a while keeping the blood flow blocking portion 20a attached to the needle hub 40.

The attachment structure of the needle hub 40 and the blood flow blocking portion 20a may be such that the first engagement portion 50 is a convex portion and the second engagement portion 58 is a concave portion (hole portion). Furthermore, the attachment structure is not limited to a fitting structure using convex and concave portions, but may be a claw engagement structure, a magnetic attraction structure, a hook-and-loop fastener engagement structure, a screw-threaded structure, etc.

The first engaging portion 50, the second engaging portion 58, the mounting portion 64, and the connecting portion 76 are preferably formed so that the direction of the force acting on the blood flow blocking portion 20a when the blood flow blocking portion 20a is separated from the needle hub 40 is different from the direction of the force acting on the light source unit 22 when the light source unit 22 is separated from the blood flow blocking portion 20a. That is, for example, if the first engaging portion 50 and the second engaging portion 58 are of a fitting structure along the axial direction of the needle body 38, the mounting portion 64 and the connecting portion 76 are preferably formed of a screw-type screw structure. In such a case, the light source unit 22 can be easily removed from the blood flow blocking portion 20a while the blood flow blocking portion 20a is attached to the needle hub 40.

The blood vessel puncture device 12A according to this modified example can be used in the following manner. For example, as shown in FIG. 14A, before the blood vessel puncture device 12A is used, a filter cap 400 (blood flow blocking portion) to which the light source unit 22 cannot be attached may be removably connected to the base end of the needle hub 40.

In such a case, the filter cap 400 is removed from the needle hub 40, and the blood flow blocking part 20a with the light source unit 22 attached is attached to the needle hub 40 as shown in Figures 14B and 15A. Then, after securing the blood vessel at the tip of the linear part 24 (needle body 38 and catheter shaft 28), the needle member 18a is removed from the catheter member 16 and the light source unit 22 is removed from the blood flow blocking part 20a (see Figure 15B). The removed light source unit 22 is reused. The needle member 18a and the blood flow blocking part 20a attached to the needle hub 40 are discarded together.

In this modified example, the blood flow blocking section 20a is detachable from the base end of the needle hub 40.

With this configuration, even if a filter cap 400 that cannot be fitted with a light source unit 22 is removably connected to the base end of the needle hub 40, the filter cap 400 can be replaced with a blood flow blocking section 20a to which the light source unit 22 can be attached.

This modified example is not limited to the configuration described above. The blood vessel puncture device 12A may be equipped with

light source units

22a and 22b instead of the light source unit 22.

(Second Modification)
As shown in Fig. 16, the blood vessel puncture device 12B according to the second modification includes a catheter member 16, a needle member 18b, a blood flow blocking section 20, and a light source unit 22. The needle member 18b has a needle body 38a and a needle hub 40. The inner peripheral surface of the needle body 38a is coated with a reflecting section 130 (reflective film) for reflecting the light L1 emitted by the light source section 66. The inner peripheral surface (inner surface) of the needle body 38a includes both a portion located in the range from the base end of the needle body 38a to the base end of the tip opening 46 and a portion located in the range from the base end of the tip opening 46 to the tip of the tip opening 46. In other words, the reflecting section 130 is also provided on the inner surface of the needle body 38a that is visible through the tip opening 46 from the outside of the needle body 38a.

In the blood vessel puncture device 12B, the light L1 emitted by the light source unit 66 is guided in the order of the light guide hole 78, the filter 56, the blood flow path 60, the lumen 52 of the needle hub 40, and the lumen 42 of the needle body 38a. The light L1 introduced into the lumen 42 of the needle body 38a is guided toward the tip while reflecting off the reflector 130 provided on the inner surface of the needle body 38a, and is guided out from the tip opening 46 of the needle body 38a. In the blood vessel puncture device 12B, the light guide hole 78, the filter 56, the blood flow path 60, the lumen 52 of the needle hub 40, and the lumen 42 of the needle body 38a form an optical path 134 that guides the light L1 emitted by the light source unit 66 to the tip of the needle body 38a.

In such a vascular puncture device 12B, when the light source unit 66 emits highly directional light L1 (e.g., laser light, etc.), a large amount of light L1 can be guided out from the tip opening 46 of the needle body 38a. As with the above-mentioned vascular puncture device 12, the light L1 emitted by the light source unit 66 is also guided to the tip 35 of the catheter shaft 28. In other words, in this modified example, the light L1 emitted by the light source unit 66 is guided out from the tip opening 46 of the needle body 38a and the tip 35 of the catheter shaft 28. However, the light L1 does not have to be guided out from the tip 35 of the catheter shaft 28.

In the vascular puncture device 12B, in the received light image 90 of the linear portion 24 before the blood vessel is secured, the tip opening 46 of the needle body 38a and the tip 35 of the catheter shaft 28 are displayed most brightly (white) (see Figure 17).

In addition, when the tip opening 46 of the needle body 38a is inserted into the blood vessel 302 but the tip 35 of the catheter shaft 28 is not inserted into the blood vessel 302, the tip opening 46 of the needle body 38a appears dark in the received light image 90 while the tip 35 of the catheter shaft 28 appears bright (white) (see FIG. 6). Then, when the tip opening 46 of the needle body 38a and the tip 35 of the catheter shaft 28 are inserted into the blood vessel 302, the tip 35 of the catheter shaft 28 also appears dark in the received light image 90 (see FIG. 8).

In this modified example, the light L1 emitted by the light source unit 66 is guided through the inner cavity 42 of the needle body 38a and is guided out from the tip opening 46 of the needle body 38a.

With this configuration, it is possible to easily and quickly determine whether the needle body 38a has secured a blood vessel based on the light L1 emitted by the light source unit 66.

The inner surface of the needle body 38a is provided with a reflecting portion 130 that reflects the light L1 emitted by the light source portion 66.

With this configuration, the light L1 emitted by the light source unit 66 can be efficiently guided to the tip opening 46 of the needle body 38a.

The blood vessel puncture device 12B according to this modified example may have a blood flow blocking section 20b shown in FIG. 18 instead of the blood flow blocking section 20. The blood flow blocking section 20b includes a support section 140 and a filter 142. The support section 140 has a plurality of blood flow paths 144. These blood flow paths 144 are located on the outer periphery of the support section 140. In other words, the central section 146 of the support section 140 is closed by a wall section. The central section 146 of the support section 140 is transparent so that the light L1 emitted by the light source section 66 can pass through.

Each blood flow path 144 extends from the distal end surface of the support part 140 (the distal end surface of the second engagement part 58) to the proximal end surface of the support part 140. The multiple blood flow paths 144 are arranged at intervals in the circumferential direction of the support part 140. The filter 142 is fixed to the proximal end surface of the support part 140 so as to cover the proximal end openings of the multiple blood flow paths 144. The filter 142 extends in an annular shape (e.g., annular). The lumen 52 of the needle hub 40 and the multiple blood flow paths 144 form a blood inlet portion 148 for checking flashback.

In this type of blood flow blocking section 20b, the light L1 emitted by the light source section 66 passes through the center section 146 of the support section 140 (without passing through the filter 142) and is guided to the lumen 52 of the needle hub 40. In this case, the filter 142 is not limited to materials that transmit the light L1, making it easy to select the material for the filter 142.

This modified example is not limited to the above-mentioned configuration. The blood vessel puncture device 12B may be equipped with

light source units

22a and 22b instead of the light source unit 22. In the blood vessel puncture device 12B, the blood flow blocking unit 20 may be detachable from the base end of the needle hub 40.

(Third Modification)
19, a blood vessel puncture device 12C according to the third modification includes a catheter member 16, a needle member 18c, a blood flow blocking portion 20c, a light source unit 22, and a light guiding member 150. The needle member 18c includes a needle body 38 and a needle hub 40a.

The needle hub 40a has a needle connection hole 48, a lumen 52, a blood inlet 152 for checking flashback, a first engagement portion 50, and a filter 154. The inner peripheral surface of the needle hub 40a is provided with a guide surface 132 for guiding the light guide member 150 to the lumen 42 of the needle body 38. The guide surface 132 tapers toward the needle body 38 (tip direction). The base end of the needle body 38 is located further distally than the base end of the needle connection hole 48. The lumen 52 of the needle hub 40a is connected to the base end of the needle connection hole 48. The blood inlet 152 includes a first opening 156 that opens into the inner peripheral surface of the needle connection hole 48 and a second opening 158 that opens into the base end surface of the needle hub 40a.

The first opening 156 is located in the proximal direction from the proximal end of the needle body 38. The second opening 158 is covered by a filter 154 that is fixed to the proximal surface of the needle hub 40a. The filter 154 allows air to pass through while preventing blood from passing through.

The blood flow blocking portion 20c includes a support portion 160. The support portion 160 has a second engagement portion 58, an attachment portion 64, and an insertion hole 162. The second engagement portion 58 fits into the first engagement portion 50 in a liquid-tight and air-tight manner. The light guide member 150 is inserted into the insertion hole 162. The insertion hole 162 extends from the tip surface of the support portion 160 (the tip surface of the second engagement portion 58) to the attachment portion 64. The insertion hole 162 is located on an extension of the axis of the needle body 38. The blood flow blocking portion 20c is detachable from the base end portion of the needle hub 40a.

The light-guiding member 150 extends linearly along the axial direction of the needle body 38. The light-guiding member 150 is located on the axis of the needle body 38. The light-guiding member 150 is inserted into the inner cavity 42 of the needle body 38. The tip of the light-guiding member 150 is located near the tip opening 46 of the needle body 38.

The tip surface of the light-guiding member 150 faces the tip opening 46 of the needle body 38. The outer diameter of the light-guiding member 150 is smaller than the inner diameter of the needle body 38. In other words, a flow path 168 for guiding blood in the base end direction is formed between the outer peripheral surface of the light-guiding member 150 and the inner peripheral surface of the needle body 38. The flow path 168 extends from the tip of the light-guiding member 150 to the base end of the needle body 38.

The base end of the light-guiding member 150 is supported by the support portion 160. The base end of the light-guiding member 150 is fixed to the support portion 160 while being inserted into the insertion hole 162. However, the light-guiding member 150 may be removable from the support portion 160.

The base end surface of the light guide member 150 faces the light guide hole 78 when the light source unit 22 is attached to the attachment portion 64. The light guide member 150 is provided continuously from the tip of the needle body 38 to the blood flow blocking portion 20c. The light guide member 150 may be provided discontinuously from the tip of the needle body 38 to the blood flow blocking portion 20c. The light guide member 150 is formed solid. Examples of the light guide member 150 include an optical fiber, an acrylic rod, a glass rod, and a light emitting tube.

The area of the first opening 156 of the blood inlet 152 is larger than the cross-sectional area of the annular flow path formed between the outer peripheral surface of the light-guiding member 150 and the inner peripheral surface of the needle connection hole 48 in the proximal direction from the first opening 156 of the needle connection hole 48. Therefore, blood guided from the inner cavity 42 of the needle body 38 to the needle connection hole 48 flows preferentially into the blood inlet 152. In other words, blood can be effectively prevented from flowing into the inner cavity 52 of the needle hub 40a.

In the blood vessel puncture device 12C, the above-mentioned filter cap 400 (see FIG. 14A) is removed from the base end of the needle hub 40a, and the blood flow blocking portion 20c to which the light guiding member 150 is attached is attached to the base end of the needle hub 40a. At this time, when the blood flow blocking portion 20c is attached to the needle hub 40a, the light guiding member 150 is inserted into the inner cavity 42 of the needle body 38 while being guided by the guide surface 132. Note that in the blood vessel puncture device 12C, the light guiding member 150 may be inserted alone into the inner cavity 42 of the needle body 38, and then the light guiding member 150 may be bonded (attached) to the blood flow blocking portion 20c.

In the blood vessel puncture device 12C, the light L1 emitted by the light source unit 66 is guided to the tip opening 46 of the needle body 38 via the light guide hole 78 and the light guide member 150. In the blood vessel puncture device 12C, the light guide hole 78 and the light guide member 150 form a light path 170 that guides the light L1 emitted by the light source unit 66 to the tip of the needle body 38.

In such a vascular puncture device 12C, when the light source unit 66 emits highly directional light L1 (e.g., laser light, etc.), a large amount of light L1 can be guided out from the tip opening 46 of the needle body 38. As with the above-mentioned vascular puncture device 12, the light L1 emitted by the light source unit 66 is also guided to the tip 35 of the catheter shaft 28. In other words, in this modified example, the light L1 emitted by the light source unit 66 is guided out from the tip opening 46 of the needle body 38 and the tip 35 of the catheter shaft 28. However, the light L1 does not have to be guided out from the tip 35 of the catheter shaft 28.

In the blood vessel puncture device 12C, the appearance of the received light image 90 is similar to that of the blood vessel puncture device 12B of the second modified example, so a description thereof will be omitted.

The optical path 170 includes a light-guiding member 150 for guiding the light L1 from the light source unit 22 to the tip of the needle body 38.

With this configuration, the light L1 emitted by the light source unit 66 can be guided out from the tip opening 46 of the needle body 38.

The tip of the light-guiding member 150 is positioned at the tip of the needle body 38 when inserted into the inner cavity 42 of the needle body 38.

With this configuration, the light L1 emitted by the light source unit 66 can be efficiently guided to the tip opening 46 of the needle body 38.

The base end of the light-guiding member 150 is supported by the blood flow blocking section 20c.

This configuration prevents the base end of the light-guiding member 150 from shifting relative to the blood flow blocking portion 20c, so that the light L1 emitted by the light source 66 can be efficiently guided to the light-guiding member 150.

The blood flow blocking portion 20c is detachable from the base end of the needle hub 40a. The inner surface of the needle hub 40a is provided with a guide surface 132 for guiding the light guide member 150 into the inner cavity 42 of the needle body 38 when the blood flow blocking portion 20c is attached to the base end of the needle hub 40a. The guide surface 132 tapers toward the needle body 38.

With this configuration, when the blood flow blocking portion 20c is attached to the base end of the needle hub 40a, the guide surface 132 allows the light guide member 150 to be smoothly inserted into the inner cavity 42 of the needle body 38.

This modified example is not limited to the above-mentioned configuration. The blood vessel puncture device 12C may be equipped with

light source units

22a and 22b instead of the light source unit 22. In the blood vessel puncture device 12C, the blood flow blocking portion 20c may be fixed to the base end of the needle hub 40a.

(Fourth Modification)
20, a blood vessel puncture device 12D according to the fourth modification includes a catheter member 16, a needle member 18d, a blood flow blocking unit 20d, a light source unit 22, and a light guiding member 150a. The blood flow blocking unit 20d includes a support member 180 and a filter 56.

Needle member 18d has a needle body 38 and a needle hub 40b. The inner peripheral surface of needle hub 40b is provided with the above-mentioned guide surface 132.

The support part 180 has a second engagement part 58, an attachment part 64, an insertion hole 182, and a blood inlet part 184 for checking flashback. The light guide member 150a is inserted into the insertion hole 182. The insertion hole 182 opens to the distal end surface of the support part 180 (the distal end surface of the second engagement part 58). In other words, the insertion hole 182 is connected to the inner cavity 52 of the needle hub 40b. The blood inlet part 184 is connected to the base end of the insertion hole 182. The filter 56 is supported by the support part 180 so as to prevent blood in the blood inlet part 184 from flowing to the attachment part 64.

The light-guiding member 150a is formed in a tubular shape. The light-guiding member 150a is made of acrylic, glass, a light-emitting tube, or the like. The light-guiding member 150a extends linearly along the axial direction of the needle body 38. The light-guiding member 150a is located on the axis of the needle body 38. The light-guiding member 150a is inserted into the inner cavity 42 of the needle body 38. The tip of the light-guiding member 150a is located near the tip opening 46 of the needle body 38. The tip surface of the light-guiding member 150a faces the tip opening 46 of the needle body 38. The outer peripheral surface of the light-guiding member 150a is in liquid-tight contact with the inner peripheral surface of the needle body 38. However, the outer peripheral surface of the light-guiding member 150a may be spaced from the inner peripheral surface of the needle body 38.

The base end of the light-guiding member 150a is supported by the support portion 180. The base end of the light-guiding member 150a is fixed to the support portion 180 while inserted into the insertion hole 182. However, the light-guiding member 150a may be removable from the support portion 180. The base end surface of the light-guiding member 150a is located on the optical axis of the light source portion 66. The base end of the inner cavity 151 of the light-guiding member 150a is connected to the blood inlet portion 184.

In the blood vessel puncture device 12D, the above-mentioned filter cap 400 (see FIG. 14A) is removed from the base end of the needle hub 40b, and the blood flow blocking section 20d to which the light guiding member 150a is attached is attached to the base end of the needle hub 40b. At this time, the light guiding member 150a is inserted into the lumen 42 of the needle body 38 while being guided by the guide surface 132. Note that in the blood vessel puncture device 12D, the light guiding member 150a may be inserted alone into the lumen 42 of the needle body 38, and then the light guiding member 150a may be adhered (attached) to the blood flow blocking section 20d.

In the blood vessel puncture device 12D, the light L1 emitted by the light source unit 66 is guided to the tip opening 46 of the needle body 38 via the light guide hole 78, the filter 56, the blood inlet section 184, and the light guide member 150a. In the blood vessel puncture device 12D, the light guide hole 78, the filter 56, the blood inlet section 184, and the light guide member 150a form an optical path 186 that guides the light L1 emitted by the light source unit 66 to the tip of the needle body 38.

In such a vascular puncture device 12D, when the light source unit 66 emits highly directional light L1 (e.g., laser light, etc.), a large amount of light L1 can be guided out from the tip opening 46 of the needle body 38. As with the above-mentioned vascular puncture device 12, the light L1 emitted by the light source unit 66 is also guided to the tip 35 of the catheter shaft 28. In other words, in this modified example, the light L1 emitted by the light source unit 66 is guided out from the tip opening 46 of the needle body 38 and the tip 35 of the catheter shaft 28. However, the light L1 does not have to be guided out from the tip 35 of the catheter shaft 28.

In the blood vessel puncture device 12D, the appearance of the received light image 90 is similar to that of the blood vessel puncture device 12B of the second modified example, and therefore a description thereof will be omitted. In the blood vessel puncture device 12D of this modified example, the same configuration as the blood vessel puncture device 12C described above provides the same effects.

This modified example is not limited to the above-mentioned configuration. The blood vessel puncture device 12D may be equipped with

light source units

22a and 22b instead of the light source unit 22. In the blood vessel puncture device 12D, the blood flow blocking portion 20d may be fixed to the base end of the needle hub 40b.

(Fifth Modification)
21 , a blood vessel puncture device 12E according to the fifth modification includes a catheter member 16, a needle member 18e, a blood flow blocking portion 20e, a light source unit 22, and a light guiding member 150. The needle member 18e includes a needle body 38 and a needle hub 40c. The blood flow blocking portion 20e is liquid-tightly attached to the base end of the needle hub 40c and is movable along the axial direction of the needle body 38.

The base end (first engagement portion 50) of the needle hub 40c is provided with a female thread portion 41. The configuration of the needle hub 40c other than the female thread portion 41 is the same as that of the needle hub 40a described above. The tip end (second engagement portion 58) of the blood flow blocking portion 20e is provided with a male thread portion 21 that screws into the female thread portion 41. The configuration of the blood flow blocking portion 20e other than the male thread portion 21 is the same as that of the blood flow blocking portion 20c described above.

In the blood vessel puncture device 12E, the tip position of the light-guiding member 150 relative to the tip opening 46 of the needle body 38 can be displaced in the axial direction of the needle body 38 by rotating the blood flow blocking portion 20e relative to the needle hub 40c. That is, the male thread portion 21 and the female thread portion 41 function as a position adjustment mechanism for adjusting the tip position of the light-guiding member 150 relative to the tip opening 46 in the axial direction of the needle body 38. The male thread portion 21 is in liquid-tight contact with the female thread portion 41. That is, the male thread portion 21 and the female thread portion 41 also have the function of preventing blood from leaking between the needle hub 40c and the blood flow blocking portion 20e.

In the vascular puncture device 12E, the light-guiding member 150 protrudes from the tip opening 46. In particular, the tip of the light-guiding member 150 is located between the tip of the needle body 38 and the base end of the tip opening 46. This allows the tip of the needle body 38 to emit light efficiently while suppressing the puncture resistance of the needle body 38.

The tip position of the light-guiding member 150 may deviate from the appropriate position (position in FIG. 21) due to manufacturing tolerances of the blood vessel puncture device 12E (assembly tolerances, variation in the length of the light-guiding member 150, etc.). If the tip of the light-guiding member 150 is located more distally than the tip of the needle body 38, the puncture resistance increases. Also, if the tip of the light-guiding member 150 is located more proximally than the proximally of the tip opening 46, the amount of light guided from the tip opening 46 decreases. The deviation from the appropriate position of the tip of the light-guiding member 150 due to manufacturing tolerances is 1 mm or less. In other words, in this modified example, if the adjustment margin for the tip position of the light-guiding member 150 is about 1 mm, the tip of the light-guiding member 150 can be adjusted to the appropriate position. In this case, even if the blood flow blocking portion 20e is rotated relative to the needle hub 40c to adjust the tip position of the light-guiding member 150, the male thread portion 21 and the female thread portion 41 maintain a liquid-tight contact state. In other words, blood leakage between the male thread portion 21 and the female thread portion 41 can be prevented.

The blood vessel puncture device 12E may be provided with a locking mechanism that prevents the blood flow blocking portion 20e from rotating relative to the needle hub 40c after the tip position of the light guiding member 150 has been adjusted. In this case, it is possible to prevent the tip of the light guiding member 150 from shifting from the appropriate position when the blood vessel puncture device 12E is in use, etc. A sealing member (not shown) that prevents blood from leaking between the blood flow blocking portion 20e and the needle hub 40c may be provided on the base end side of the male thread portion 21 in the second engagement portion 58. An example of such a sealing member is an annular rubber seal.

In the blood vessel puncture device 12E, the blood flow blocking portion 20e is liquid-tightly attached to the base end of the needle hub 40c and can move along the axial direction of the needle body 38. With this configuration, even if the tip position of the light-guiding member 150 deviates from the appropriate position due to manufacturing tolerances in the blood vessel puncture device 12E, the tip of the light-guiding member 150 can be easily adjusted to the appropriate position by moving the blood flow blocking portion 20e in the axial direction of the needle body 38 relative to the needle hub 40c.

Furthermore, a female thread portion 41 is provided at the base end of the needle hub 40c, and a male thread portion 21 that screws into the female thread portion 41 is provided at the tip end of the blood flow blocking portion 20e. With this configuration, the tip position of the light guide member 150 can be easily adjusted by rotating the blood flow blocking portion 20e relative to the needle hub 40c.

Furthermore, the male thread portion 21 is in liquid-tight contact with the female thread portion 41. With this configuration, it is not necessary to provide a seal member or the like to prevent blood from leaking between the needle hub 40c and the blood flow blocking portion 20e, simplifying the configuration of the blood vessel puncture device 12E. In addition, the seal member does not increase the rotational resistance of the blood flow blocking portion 20e relative to the needle hub 40c, making it easy to adjust the tip position of the light-guiding member 150.

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

Claims

A blood vessel puncture device comprising a linear portion capable of puncturing a blood vessel at a living body site, the linear portion including a tubular needle body, and a needle hub provided at a base end of the needle body,
a blood flow blocking portion provided at a proximal end of the needle hub;
a light source unit having a light source section that emits light and that is detachable from the attachment section of the blood flow blocking section;
an optical path for guiding the light emitted by the light source unit to a tip end of the linear portion,
The light emitted by the light source unit is guided to the outside from the tip end of the linear portion,
At least one of the needle hub and the blood flow blocking portion is provided with a blood inlet portion for checking flashback, into which blood flowing in from the tip opening of the needle body is guided;
A blood vessel puncture device, wherein the blood flow blocking portion is formed to block the flow of blood to the attachment portion.
The vascular puncture device according to claim 1,
A blood vessel puncture device, wherein when the light source unit is attached to the attachment portion, the light source portion emits the light toward the tip direction of the linear portion.
The vascular puncture device according to claim 1,
The light source unit has a housing that accommodates the light source portion,
A vascular puncture device, wherein the housing has a connection portion that is detachable from the mounting portion.
The vascular puncture device according to claim 1,
A blood vessel puncture device, wherein the blood flow blocking portion is fixed to the base end of the needle hub.
The vascular puncture device according to claim 1,
A blood vessel puncture device, wherein the blood flow blocking portion is detachable from the base end portion of the needle hub.
The vascular puncture device according to claim 1,
A blood vessel puncture device, wherein the light emitted by the light source unit is guided through an inner cavity of the needle body and out of the tip opening of the needle body.
The vascular puncture device according to claim 6,
A blood vessel puncture device, wherein an inner surface of the needle body is provided with a reflecting portion that reflects the light emitted by the light source portion.
The vascular puncture device according to claim 6,
A blood vessel puncture device, wherein the optical path includes a light guiding member for guiding the light emitted by the light source unit to the tip of the needle body.
9. The vascular puncture device according to claim 8,
A blood vessel puncture device, wherein the tip of the light guiding member is positioned at the tip of the needle body when inserted into the inner cavity of the needle body.
9. The vascular puncture device according to claim 8,
A blood vessel puncture device, wherein a proximal end of the light guiding member is supported by the blood flow blocking portion.
11. The vascular puncture device of claim 10,
the blood flow blocking portion is detachable from the base end portion of the needle hub,
a guide surface is provided on an inner surface of the needle hub for guiding the light guiding member into the inner cavity of the needle body when the blood flow blocking unit is attached to the base end of the needle hub;
A blood vessel puncture device, wherein the guide surface tapers toward the needle body.
The vascular puncture device according to claim 1,
The blood flow blocking portion is
a filter that blocks the flow of blood from the blood inlet portion to the attachment portion;
A support portion that supports the filter,
A vascular puncture device, wherein the mounting portion is provided at a base end of the support portion.
The vascular puncture device according to claim 1,
A vascular puncture device, wherein the light source unit emits light including near-infrared light.
The vascular puncture device according to claim 1,
a tubular catheter shaft having a lumen through which the needle body is inserted;
a catheter hub provided at a base end of the catheter shaft and having an inner cavity through which the needle body is inserted;
A vascular puncture device, wherein the linear portion includes the needle body and the catheter shaft.
15. The vascular puncture device of claim 14,
the optical path is provided on a wall of the blood flow blocking portion, a wall of the needle hub, a wall of the catheter hub, and a wall of the catheter shaft;
A vascular puncture device, wherein the light emitted by the light source unit is guided to the outside from the tip of the catheter shaft.
16. The vascular puncture device of claim 15,
A vascular puncture device, wherein the outer peripheral surfaces of each of the wall portions of the blood flow blocking portion, the wall portion of the needle hub, the wall portion of the catheter hub, and the wall portion of the catheter shaft are provided with a light transmission suppression portion that suppresses the transmission of the light emitted by the light source portion.
11. The vascular puncture device of claim 10,
A blood vessel puncture device, wherein the blood flow blocking portion is liquid-tightly attached to the base end of the needle hub and is movable along the axial direction of the needle body.
18. The vascular puncture device of claim 17,
The proximal end of the needle hub is provided with an internal thread portion,
A blood vessel puncture device, wherein a tip portion of the blood flow blocking portion is provided with a male thread portion that screws into the female thread portion.
20. The vascular puncture device of claim 18,
A vascular puncture device, wherein the male threaded portion is in liquid-tight contact with the female threaded portion.
A vascular puncture device according to any one of claims 1 to 19,
a light receiving portion that receives the light guided from the tip portion of the linear portion;
and an image display unit that displays a received light image created based on the light received by the light receiving unit.