JP2014136115A - Indwelling needle - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an indwelling needle that can reduce the amount of X-ray exposure.SOLUTION: An indwelling needle includes a hollow sheath conductor part, and a sheath base part which is fixed to a base end part of the sheath conductor part and is composed of a cylindrical member. At least a part of the sheath conductor part includes a near infrared fluorescent dye that emits near infrared fluorescence upon near infrared irradiation with wavelengths of 500-1400 nm.

Description

  The present invention relates to an indwelling needle. More specifically, the present invention relates to an indwelling needle containing a near-infrared fluorescent dye in at least a part of a sheath conductor portion.

  A medical device such as a stent or an injection needle that is inserted into a living body is required to be able to confirm the position in the body in order to reduce tissue damage such as blood vessels and improve the operability of the operator. For example, when an injection needle such as dialysis is inserted into a specific blood vessel, there is a demand for an injection needle that can confirm during the operation whether or not the injection needle is surely contained in the target blood vessel.

  As such a medical device, Patent Document 1 proposes an indwelling tube guide that is introduced to a target lesion under fluoroscopy and treated.

International Publication No. 2003/092782

  X-ray fluoroscopy is not usually performed with an indwelling needle centered on blood collection. However, when an indwelling needle is inserted in advance during the placement of an arterial sheath and a central vein (CV) catheter, the guide wire is also used for introduction, so X-ray fluoroscopy is performed. For this reason, there has been a problem that the burden on the patient and the operator due to the X-ray exposure is increased, and the operation of the operator is restricted, which impedes rapid surgery. This issue is a problem that cannot be overlooked in view of the growing interest in radiation exposure in recent years. In addition, there is a problem that the inspection machine is large and requires a lot of labor to maintain it.

  Therefore, this invention is made | formed in view of the said situation, and it aims at providing the indwelling needle which can reduce an X-ray exposure amount.

  As a result of intensive studies to solve the above problems, the present inventors have solved the above problems by using a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light of a specific wavelength for the indwelling needle. The present invention has been completed by finding out what can be done.

  That is, the object is an indwelling needle having a hollow sheath conductor portion and a sheath base portion that is fixed to a proximal end portion of the sheath conductor portion and configured by a cylindrical member, At least a part can be achieved by an indwelling needle containing a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a wavelength of 500 to 1400 nm.

  According to the present invention, the indwelling needle can be visually recognized safely.

It is a whole side view which shows the puncture tool which attached the syringe to the indwelling needle which concerns on this embodiment. FIG. 2 is an enlarged side sectional view showing a section of the indwelling needle shown in FIG. FIG. 3A is a schematic cross-sectional view showing the indwelling needle of the first embodiment of the present invention. FIG. 3B is a schematic cross-sectional view showing the indwelling needle of the second embodiment of the present invention. It is a figure explaining one Embodiment of the technique using the indwelling needle of this invention. It is a figure explaining the position confirmation system of the indwelling needle which is one Embodiment of the indwelling needle of this invention. FIG. 6 is an image of the patient's blood vessel and the indwelling needle in the blood vessel confirmed by the system of FIG.

  The present invention is an indwelling needle having a hollow sheath conductor portion and a sheath base portion fixed to a proximal end portion of the sheath conductor portion and configured by a tubular member, and at least one of the sheath conductor portions. The part relates to an indwelling needle containing a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a wavelength of 500 to 1400 nm. The present invention includes a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a specific wavelength. The measurement method using light has the advantage that there is no problem of exposure and the indwelling needle can be visually recognized by irradiating light with a selected wavelength. Moreover, since near-infrared light (near-infrared light) excellent in the permeability | transmittance of the biological body is used as irradiated light, the indwelling needle introduced into the biological body can be confirmed noninvasively and well. Is possible. That is, by irradiating the indwelling needle with near-infrared light having a wavelength of 500 to 1400 nm, the near-infrared fluorescent dye emits near-infrared fluorescence, thereby visualizing the indwelling needle. Furthermore, since the positional relationship between both the indwelling needle and the vein travel can be confirmed, the indwelling needle can be reliably placed in the target blood vessel.

  For example, when a high concentration nutrient is infused into a patient, a sheath (also referred to herein as “outer needle” or “catheter”) and a puncture needle (herein referred to as “inner needle”). The patient is punctured with an indwelling needle containing the puncture needle, the puncture needle is removed, a guide wire is inserted through the sheath, and the blood vessel (vein) close to the heart is reached, and then the sheath is removed. Then, the central venous catheter is indwelled, and the infusion is performed by connecting an infusion line supplied with nutrients, chemicals, and the like. According to the present invention, when such an indwelling needle is punctured, the sheath conductor portion of the indwelling needle includes a near-infrared fluorescent dye that emits near-infrared fluorescence. As a result, the near-infrared fluorescent dye emits near-infrared fluorescence, and the running of the vascular vessel and the indwelling needle can be visually confirmed, and the indwelling position of the indwelling needle is ensured. Furthermore, in the treatment of repeated intravenous indwelling frequently such as cancer chemotherapy, the vascular that can be punctured is localized due to occlusion of the vascular that can administer the drug. It is very useful that the indwelling position of the indwelling needle becomes more reliable by using an indwelling needle containing a near-infrared fluorescent dye that emits near-infrared fluorescence for such a patient.

  Furthermore, when performing arterial puncture with an indwelling needle, a technique for reliably puncturing the target artery is required. Moreover, in order to perform puncture reliably, a very skillful technique is required. For example, if there is a mistake in the puncture site, bleeding may occur in a large amount and it may be difficult to stop the hemostasis. In the present invention, by using an indwelling needle containing a near-infrared fluorescent dye that emits near-infrared fluorescence, even when performing arterial puncture, the target artery can be reliably punctured, and the puncture site can be Can be confirmed. Furthermore, in the case of arterial puncture running deeper, it is very useful that the indwelling position of the indwelling needle becomes more reliable by using an indwelling needle containing a near-infrared fluorescent dye that emits near-infrared fluorescence. .

(Indwelling needle)
An indwelling needle 1 according to an embodiment of the present invention will be described with reference to FIGS. FIG. 1 is an overall side view showing a puncture device 100 in which a syringe 10 is attached to an indwelling needle 1 according to this embodiment. FIG. 2 is an enlarged side sectional view showing a section of the indwelling needle 1 shown in FIG. In addition, this invention is not limited only to the following embodiment. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios.

  In the present specification, “X to Y” indicating a range means “X or more and Y or less”, and “weight” and “mass”, “wt%” and “mass%”, “part by weight” and “ “Part by mass” is treated as a synonym. Unless otherwise specified, measurement of operation and physical properties is performed under conditions of room temperature (20 to 25 ° C.) / Relative humidity 40 to 50%.

  In the following description, the left side in FIGS. 1 and 2 is referred to as the “front end side” and the right side is referred to as the “base end side”, and the same applies to other drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may be different from the actual ratios. Moreover, in FIG. 1 and FIG. 2, the site | part visualized with the near-infrared fluorescent dye is abbreviate | omitted and shown.

  A puncture device 100 shown in FIG. 1 includes an indwelling needle 1 and a syringe 10.

  The indwelling needle 1 of the present invention includes a hollow sheath conductor portion 2 and a sheath base portion 3 that is fixed to a proximal end portion of the sheath conductor portion and is configured by a cylindrical member. In this specification, the sheath conductor portion 2 and the sheath base portion 3 are collectively referred to as a “sheath”. The indwelling needle of the present invention may further include an inner needle 4 that is inserted through the hollow interior of the sheath conductor portion, and an inner needle base portion 5 that is fixed to the proximal end portion of the inner needle. The inner needle preferably has a sharp needle tip at the tip.

  Specifically, the indwelling needle 1 is inserted through the sheath conductor portion 2, a sheath conductor portion (outer needle) 2 that is punctured and placed in a blood vessel, a sheath base portion 3 having the sheath conductor portion 2 on the distal end side, and the sheath conductor portion 2. The inner needle 4 has a distal tip protruding beyond the sheath conductor 2 and the inner needle base 5 having the inner needle 4 on the distal side. Moreover, the syringe 10 is for making the inner needle base space 52 mentioned later into a negative pressure, and the front-end | tip of the syringe 10 is inserted and fitted to the opening location of the base end side of an inner needle base.

  FIG. 2 is a partially omitted enlarged cross-sectional view of the puncture instrument 100 showing the sheath conductor portion 2, the sheath base portion 3, the inner needle 4, the inner needle base portion 5, and the peripheral portion thereof.

  The sheath conductor portion 2 is formed so as to be transparent from a resin material, for example, has an appropriate elasticity, and covers the outer surface side of the inner needle 4. The sheath conductor portion 2 reaches the vicinity of the distal end of the inner needle 4, and when the distal end of the inner needle 4 is inserted into a blood vessel, the sheath conductor portion 2 is also inserted into the same blood vessel.

  It is preferable that the sheath conductor part 2 has flexibility, and all or part of the sheath conductor part 2 is transparent. The reason why all or part of the sheath conductor portion 2 is preferably transparent is that it is possible to visually recognize that blood has flowed into the sheath conductor portion 2.

  The constituent material of the sheath conductor portion 2 is not particularly limited, and a resin that is normally used as a material constituting the sheath conductor portion can be used. For example, polyolefin such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyolefin elastomer, polyvinyl chloride, polyester, polyester elastomer, polyether nylon, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polystyrene, polyacetal, polycarbonate, poly At least selected from the group consisting of methacrylic resins such as methyl methacrylate, polyvinyl alcohol, polysulfone, polyimide, polyetherimide, polyethersulfone, polyetheretherketone, polybutadiene, ethylene-tetrafluoroethylene, and the like, and silicone resin One or more resins may be mentioned. In addition, the said resin may be used individually by 1 type, or may be used in the form of a mixture of 2 or more types.

  The indwelling needle of the present invention is characterized in that at least a part of the sheath conductor portion 2 includes a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a wavelength of 500 to 1400 nm. Here, the arrangement form of the near-infrared fluorescent dye on the sheath conductor portion 2 is not particularly limited. For example, (a) a form that is introduced (included) into or part of the sheath conductor part, and (b) a sheath. Any form such as covering (applying) the surface of at least a part or all of the conductor part may be used. That is, in the indwelling needle of the present invention, as a preferred embodiment in which at least a part of the sheath conductor part contains a near-infrared fluorescent dye, at least a part of the sheath conductor part is formed of a material containing a near-infrared fluorescent dye. Or at least a part of the surface of the sheath conductor portion is coated with a material containing a near-infrared fluorescent dye.

  In the said form (a), a near-infrared fluorescent dye may be included in the sheath conductor part 2 whole of the indwelling needle of this invention, or a near-infrared fluorescent dye may be included in a part of sheath conductor part 2. However, in the latter case, it is preferable to include a near-infrared fluorescent dye at the distal end portion of the sheath conductor portion in consideration of the visual recognition effect of the sheath. Similarly, in the above-described form (b), the surface of the sheath conductor portion 2 of the indwelling needle of the present invention may be coated (coated) with the near-infrared fluorescent dye or the surface of the sheath conductor portion 2 of the indwelling needle. Near infrared fluorescent dye may be coated (applied) to a part of the wire, but in the latter case, in consideration of the effect of visual recognition of the sheath, the near infrared fluorescent dye is applied to the surface of the distal end portion of the sheath conductor portion. It is preferable to coat (apply). The near-infrared fluorescent dye is disposed (applied) on either the surface (outer surface) of the sheath conductor part or the surface of the conductor part of the lumen lumen (also referred to as “inner surface” in the present specification). However, it is preferable to arrange (apply) a near-infrared fluorescent dye on the surface (outer surface) of the sheath conductor part in view of the visibility at the time of near-infrared irradiation, that is, the sheath conductor part It is preferable that at least a part of the surface (outer surface) is coated with a material containing a near-infrared fluorescent dye. In consideration of safety, it is preferable to arrange (apply) a near-infrared fluorescent dye on the lumen lumen, that is, at least a part of the surface of the lumen lumen is coated with a material containing the near-infrared fluorescent dye. It is preferred that

  The sheath conductor part 2 means a sheath body. The conductor portion visualized by the near-infrared fluorescent dye is referred to as a conductor portion 2a. FIG. 3A shows an embodiment in which the indwelling needle 1 of the present invention has a portion of the sheath conductor portion 2 visualized by a near-infrared fluorescent dye. The conductor portion 2a visualized by the near-infrared fluorescent dye may be on either the outer surface or the inner surface of the sheath conductor portion, and the entire distal end side, proximal end side, or central side of the sheath. Or a part may be sufficient and the location visualized may be multiple.

  The sheath base 3 is a resin member formed in a hollow cylindrical shape having both ends opened in the axial direction. The constituent material of the sheath base 3 is not particularly limited, and a resin that is normally used as a material constituting the sheath base can be used. For example, polyolefin such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyolefin elastomer, polyvinyl chloride, polyester, polyester elastomer, polyether nylon, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polystyrene, polyacetal, polycarbonate, poly At least selected from the group consisting of methacrylic resins such as methyl methacrylate, polyvinyl alcohol, polysulfone, polyimide, polyetherimide, polyethersulfone, polyetheretherketone, polybutadiene, ethylene-tetrafluoroethylene, and the like, and silicone resin One or more resins may be mentioned. In addition, the said resin may be used individually by 1 type, or may be used in the form of a mixture of 2 or more types.

  The proximal end portion of the sheath 2 is connected and fixed to the distal end portion of the sheath base portion 3.

  The inner needle 4 is a hollow tube body having a sharp needle tip at the distal end portion, and the proximal end portion is held at the distal end portion of the inner needle base portion 5. The material of the inner needle 4 is preferably a metal such as stainless steel, aluminum, aluminum alloy, titanium, or titanium alloy, but is not limited thereto. The length of the inner needle 4 only needs to be long enough to protrude from the end face on the distal end side of the sheath 2 in the assembled state. The outer diameter of the inner needle 4 is not particularly limited as long as it can be inserted into the sheath, but is usually about 0.2 to 4.5 mm, more preferably about 0.3 to 3.0 mm.

  In the present invention, it is preferable that at least a part of the surface of the tip portion of the inner needle is coated with a material containing a near-infrared fluorescent dye.

  FIG. 3B shows that the indwelling needle 1 of the present invention is such that a part of the conductor portion of the sheath 2 is visualized by the near infrared fluorescent dye, and at least a part of the surface of the tip of the inner needle is made of the near infrared fluorescent dye. One form visualized is represented. The tip portion of the inner needle visualized by the near-infrared fluorescent dye is referred to as a tip portion 4a. The tip 4a of the inner needle 4 visualized by the near-infrared fluorescent dye is either the outer surface or the inner surface of the inner needle 4 as long as it is the tip of the inner needle 4 that is not covered by the sheath. It may be the whole or a part of the tip of the inner needle, and a plurality of locations may be visualized.

  The inner needle base 5 is a resin member formed in a hollow cylindrical shape having both axial ends open. The inner needle base portion 5 includes a protruding portion 51 that protrudes toward the distal end side, and an inner needle base space 52 that is made negative pressure by the syringe 10. Moreover, it is preferable that the material of the inner needle base portion 5 is such that the inner needle base inner space 52 can be visually recognized by a translucent or transparent resin, and examples of the constituent material of the inner needle base portion 5 include the sheath base portion 3 described above. The same constituent material is mentioned. The material of the sheath base 3 and the inner needle base 5 need not be the same.

As mentioned above, although the structure of the indwelling needle which concerns on embodiment of this invention was demonstrated, the structure of the indwelling needle of this invention is not limited above, For example, Unexamined-Japanese-Patent No. 2012-71052, Unexamined-Japanese-Patent No. 2012-29974, Japanese Patent Application Laid-Open Nos. 2012-5647, 2011-120760, 2011-45544, 2011-111000, 2010-11914, 2009-233007, etc. In the present invention, the form of a needle is also included. In the present invention, a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a wavelength of 500 nm to 1400 nm (hereinafter also simply referred to as “near-infrared fluorescent dye”) Although it will not restrict | limit especially if it emits near-infrared fluorescence at the time of near-infrared irradiation, Near-infrared fluorescence at the time of near-infrared irradiation of wavelength 600nm-1400nm It is preferable that it is a near infrared fluorescent pigment | dye which emits. As such a near-infrared fluorescent dye, for example, the following formula (1) described in JP-A No. 2011-162445:

And an azo-boron complex compound represented by the following formula (2):

And indocyanine green, patent blue, indigo carmine and the like.

  In the above formula (1), X represents an unsubstituted or substituted aryl group or an unsubstituted or substituted heteroaryl group.

  Here, “unsubstituted aryl group” means an aromatic hydrocarbon group. The unsubstituted aryl group is not particularly limited, but may be an aryl group having 6 to 30 carbon atoms. More specifically, non-condensed hydrocarbon groups such as phenyl group, biphenyl group, terphenyl group; pentarenyl group, indenyl group, naphthyl group, azulenyl group, heptaenyl group, biphenylenyl group, fluorenyl group, acenaphthylenyl group, preadenenyl group , Condensed polycyclic hydrocarbon groups such as acenaphthenyl group, phenalenyl group, phenanthryl group, anthryl group, fluoranthenyl group, acephenanthrenyl group, aceantrirenyl group, triphenylenyl group, pyrenyl group, chrysenyl group, naphthacenyl group, etc. Can be mentioned. Among these, an aryl group having 6 to 10 carbon atoms is preferable, and a phenyl group is more preferable.

  The “unsubstituted heteroaryl group” means an aromatic heterocyclyl group having a 5-membered ring, 6-membered ring or condensed ring having at least one heteroatom such as a nitrogen atom, an oxygen atom or a sulfur atom. Although it does not restrict | limit especially as an unsubstituted heteroaryl group, A C1-C20 heteroaryl group may be sufficient. More specifically, pyridyl group, pyrimidyl group, pyridinyl group, pyrimidinyl group, pyrazinyl group, triazinyl group, furanyl group, pyrrolyl group, thiophenyl group (thienyl group), quinolyl group, quinolinyl group, quinolidinyl group, furyl group, piperidyl Group, coumarinyl group, chromenyl group, silafluorenyl group, benzofuranyl group, isobenzofuranyl group, benzimidazolyl group, benzoxazolyl group, benzthiazolyl group, dibenzofuranyl group, benzothiophenyl group, dibenzothiophenyl group, indolyl group , Isoindolyl group, carbazolyl group, pyrazolyl group, imidazolyl group, oxazolyl group, isoxazolyl group, thiazolyl group, indazolyl group, benzothiazolyl group, pyridazinyl group, cinnolyl group, quinazolyl group, quinoxalyl group, Razinyl group, phthalazine dionyl group, phthalamidyl group, chromonyl group, naphtholactamyl group, quinolonyl group, naphthalidinyl group, benzimidazolonyl group, benzoxazolonyl group, benzothiazolonyl group, benzothiazothionyl group, Quinazolonyl group, quinoxalonyl group, phthalazonyl group, dioxopyrimidinyl group, pyridonyl group, isoquinolonyl group, isoquinolinyl group, isothiazolyl group, thiadiazole group, benzisoxazolyl group, benzisothiazolyl group, indazironyl group, acridinyl group, acridonyl group Quinazoline dionyl group, quinoxaline dionyl group, benzoxazine dionyl group, benzoxazinonyl group, naphthalimidyl group, dithienocyclopentadienyl group, dithienosilacyclopentadienyl group, dithieno Roriru group, benzodithiolium phenyl group. Of these, a heteroaryl group containing a nitrogen atom is preferred, and a benzothiazolyl group is more preferred.

In addition, the substituent in the case where the aryl group or heteroaryl group has a substituent is not particularly limited, and examples thereof include a nitro group (—NO ₂ ), a cyano group (—CN), and an alkoxy having 2 to 13 carbon atoms. A carbonyl group, an alkyl group having 1 to 12 carbon atoms, a mono (alkyl) amino group of the formula: —NH (R ⁹ ) (wherein R ⁹ represents an alkyl group having 1 to 12 carbon atoms), a formula : -N (R ⁹ ) ₂ (wherein R ⁹ independently represents an alkyl group having 1 to 12 carbon atoms), a di (alkyl) amino group, a carboxyl group (—COOH), a hydroxyl group ( -OH) or an alkoxy group having 1 to 12 carbon atoms.

  Here, as the alkoxycarbonyl group having 2 to 13 carbon atoms, methoxycarbonyl group, ethoxycarbonyl group, propoxycarbonyl group, isopropoxycarbonyl group, n-butoxycarbonyl group, sec-butoxycarbonyl group, tert-butoxycarbonyl group N-pentoxycarbonyl group, isopentoxycarbonyl group, neopentoxycarbonyl group, n-hexyloxycarbonyl group, n-heptyloxycarbonyl group, n-octyloxycarbonyl group, n-nonyloxycarbonyl group, n- Examples include linear or branched alkoxycarbonyl groups such as a decyloxycarbonyl group, an n-undecyloxycarbonyl group, an n-dodecyloxycarbonyl group, and a 2-ethylhexyloxycarbonyl group. Of these, a linear or branched alkoxycarbonyl group having 2 to 13 carbon atoms is preferred.

Moreover, a C1-C12 alkyl group is a linear, branched or cyclic alkyl group. Although there is no restriction | limiting in particular as a C1-C12 alkyl group, For example, a methyl group, an ethyl group, n-propyl group, isopropyl group, n-butyl group, isobutyl group, sec-butyl group, tert-butyl Group, n-pentyl group, isopentyl group, tert-pentyl group, neopentyl group, 1,2-dimethylpropyl group, n-hexyl group, isohexyl group, 1,3-dimethylbutyl group, 1-isopropylpropyl group, 1, 2-dimethylbutyl group, n-heptyl group, 1,4-dimethylpentyl group, 3-ethylpentyl group, 2-methyl-1-isopropylpropyl group, 1-ethyl-3-methylbutyl group, n-octyl group, 2 -Ethylhexyl group, 3-methyl-1-isopropylbutyl group, 2-methyl-1-isopropyl group, 1-t-butyl-2-methyl Lopyl group, n-nonyl group, 3,5,5-trimethylhexyl group, n-decyl group, isodecyl group, n-undecyl group, 1-methyldecyl group, n-dodecyl group, cyclopropyl group, cyclopentyl group, cyclohexyl group , Norbornyl group, adamantyl group and the like. Of these, a linear or branched alkyl group having 1 to 10 carbon atoms is preferable. In particular, R ⁶ and R ⁷ are preferably an alkyl group having 2 to 12 carbon atoms, more preferably an alkyl group having 2 to 10 carbon atoms, and particularly preferably a linear alkyl group having 2 to 8 carbon atoms. In other cases, an alkyl group having 1 to 6 carbon atoms is preferable, an alkyl group having 1 to 4 carbon atoms is more preferable, a methyl group and an ethyl group are still more preferable, and a methyl group is particularly preferable.

In the mono (alkyl) amino group of the formula: —NH (R ⁹ ) and the di (alkyl) amino group of the formula: —N (R ⁹ ) ₂ , R ⁹ represents an alkyl group having 1 to 12 carbon atoms. Here, since the alkyl group having 1 to 12 carbon atoms has the same definition as the above alkyl group, the description is omitted here. In the di (alkyl) amino group of the formula: —N (R ⁹ ) ₂ , two R ^{9 s} may be the same or different from each other. More specifically, mono (alkyl) amino groups include methylamino group, ethylamino group, propylamino group, isopropylamino group, n-butylamino group, sec-butylamino group, tert-butylamino group, pentyl. An amino group, a hexylamino group, etc. are mentioned. Among these, preferably R ⁹ is mono- (alkyl) amino group represents an alkyl group having 1 to 6 carbon atoms, R ⁹ is more preferably mono (alkyl) amino group represents an alkyl group having 1 to 4 carbon atoms A methylamino group and an ethylamino group are particularly preferred. Di (alkyl) amino groups include dimethylamino group, diethylamino group, dipropylamino group, diisopropylamino group, dibutylamino group, diisobutylamino group, di-sec-butylamino group, di-tert-butylamino group, dipentyl Examples include amino group, dihexylamino group, ethylmethylamino group, methylpropylamino group, butylmethylamino group, ethylpropylamino group, butylethylamino group and the like. Among these, preferably R ⁹ is di (alkyl) amino group represents an alkyl group having 1 to 6 carbon atoms, R ⁹ is more preferably di (alkyl) amino group represents an alkyl group having 1 to 4 carbon atoms And particularly preferred is a di (alkyl) amino group in which R ⁹ represents a methyl group or an ethyl group.

  A C1-C12 alkoxy group is a linear or branched alkoxy group. The alkoxy group having 1 to 12 carbon atoms is not particularly limited. For example, methoxy group, ethoxy group, propoxy group, isopropoxy group, butoxy group, pentyloxy group, hexyloxy group, 2-ethylhexyloxy group, Examples include octyloxy group, nonyloxy group, decyloxy group, undecyloxy group, dodecyloxy group and the like. Among these, an alkoxy group having 1 to 6 carbon atoms is preferable, an alkoxy group having 1 to 4 carbon atoms is more preferable, a methoxy group and an ethoxy group are still more preferable, and a methoxy group is particularly preferable.

In the above formula (1), R ¹ represents an alkyl group having 1 to 12 carbon atoms, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group, or a halogen atom. Represent. Here, the two R ^{1 s} may be the same or different. Alternatively, in the above formula (1), one R ¹ represents —O—C (═O) — and is bonded to X to form a six-membered ring, and the other R ¹ represents carbon It may represent an alkyl group having 1 to 12 atoms, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group, or a halogen atom. Here, the alkyl group having 1 to 12 carbon atoms, the aryl group, and the alkoxy group having 1 to 12 carbon atoms are the same as defined in the substituent “X”, and thus the description thereof is omitted here. In the above formula (1), when two R ¹ are alkoxy groups, the hydrocarbon groups may be bonded together to form a cyclic structure together with the boron atom.

  The arylethenyl group has the following formula:

A group represented by the following formula:

It is preferable that it is group shown by these. Here, the arylethenyl group may be a trans type or a cis type, but a trans type is preferable from the viewpoint of stability. In the above formula, Ar represents an aryl group, which is the same as the definition in the substituent “X”, and thus the description thereof is omitted here. The arylethynyl group has the following formula:

Here, Ar represents an aryl group, and is the same as the definition in the substituent “X”, and thus the description thereof is omitted here. The aryloxy group is not particularly limited, but may be an aryloxy group having 6 to 30 carbon atoms. More specifically, a phenoxy group, 2-naphthyloxy group, anthracenoxy group, o, m, p-cyclohexyl-phenoxy group and the like can be mentioned. Moreover, as a halogen atom, a fluorine atom, a chlorine atom, a bromine atom, and an iodine atom are mentioned. Among these, a fluorine atom, a chlorine atom, and a bromine atom are preferable, and a fluorine atom is more preferable.

In the above formula (1), R ² and R ³ are connected to each other to —O—, —S—, or —N (R ⁸ ) — (where R ⁸ is a hydrogen atom or a carbon atom number of 1 to R ⁴ and R ⁵ represent a hydrogen atom, or R ⁴ and R ⁵ are connected to each other to represent —O—, —S— or —N (R ⁸ )-(Wherein R ⁸ represents a hydrogen atom or an alkyl group having 1 to 12 carbon atoms), and R ² and R ³ represent a hydrogen atom. Here, since the alkyl group having 1 to 12 carbon atoms is the same as the definition in the substituent “X”, the description is omitted here.

In the above formula (1), R ⁶ and R ⁷ are a hydrogen atom, an alkyl group having 1 to 12 carbon atoms, an unsubstituted or substituted aryl group, or an unsubstituted or substituted heteroaryl group. Represents. Here, R ⁶ and R ⁷ may be the same or different. In addition, the alkyl group having 1 to 12 carbon atoms, the unsubstituted or substituted aryl group, and the unsubstituted or substituted heteroaryl group are the same as defined in the substituent “X”. The description is omitted here.

Of the azo-boron complex compounds of the above formula (1), one R ¹ represents —O—C (═O) — and is bonded to X to form a 6-membered ring, and the other R ¹ represents an alkyl group having 1 to 12 carbon atoms, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group, or a halogen atom represented by the following formula (3). Azo-boron complex compounds and azo-boron complex compounds of the following formulas (4) and (5) are preferred. That is, the near-infrared fluorescent dye preferably contains an azo-boron complex compound represented by any of the following formulas (3) to (5).

However, in said formula, X and R < ¹ > -R < ⁷ > are the definitions similar to the said Formula (1),
Specific examples of such an azo-boron complex compound of the formula (1) include the following. In the following, the azo-boron complex compound of formula (1) is defined by the following symbols.

In the above formula (2), X and R ^{2 to} R ⁷ have the same definition as in the above formula (1), and thus the description thereof is omitted here.

  Specific examples of such a hydrazone compound of formula (2) include the following. In the following, the hydrazone compound of the formula (2) is defined by the following symbols.

  The hydrazone compound of the above formula (2) is a tautomer of an azo compound as described below, and the azo compound is equivalent to the hydrazone compound of the formula (2) and is included in the scope of the present invention. It is.

  Among these, considering the emission intensity (easiness of visual recognition), stability, and low deterioration property of near-infrared fluorescence, the azo-boron complex compound of the above formula (1) and the hydrazone compound of the above formula (2) Is preferred. That is, the near-infrared fluorescent dye preferably contains an azo-boron complex compound of the above formula (1) or a hydrazone compound of the above formula (2). In consideration of the emission intensity of near-infrared fluorescence (ease of visual recognition), durability of light emission (possibility of visual recognition over a long period of time), stability, low degradation, etc., the near-infrared fluorescent dye is expressed by the above formula ( It is preferably an azo-boron complex compound of 1), a hydrazone compound of the above formula (2), or a mixture thereof, and particularly preferably an azo-boron complex compound of the above formula (1). The azo-boron complex compound of the above formula (1) has very strong light absorption characteristics in the visible light region, and also exhibits good light emission properties in the near infrared region. Moreover, since the azo-boron complex compound of the above formula (1) can be easily dispersed in a polymer resin, it can be easily kneaded with the material constituting the sheath. In addition, the azo-boron complex compound of the above formula (1) has advantages such as excellent light resistance and heat resistance. For this reason, the azo-boron complex compound of the said Formula (1) is used as a near-infrared fluorescent dye excellent in the indwelling needle of this invention. Moreover, the azo-boron complex compound of the said Formula (1) can be manufactured by a simple method so that it may explain in full detail below.

  The near infrared fluorescent dye may be composed of only one kind of near infrared fluorescent dye or may be in the form of a mixture of two or more kinds. For example, when the near-infrared fluorescent dye is an azo-boron complex compound of the above formula (1), the near-infrared fluorescent dye is composed of only one kind of the azo-boron complex compound of the above formula (1). It may be configured, or may be in the form of a mixture of two or more azo-boron complex compounds of the above formula (1).

The production method of the azo-boron complex compound of the above formula (1) and the hydrazone compound of the above formula (2) is not particularly limited, and can be applied in the same manner or appropriately modified with known methods. For example, a method described in JP2011-162445A is preferably used. That is, the hydrazone compound of the above formula (2) can be produced by the reaction of an orthoquinone derivative represented by the following formula (6) and a hydrazine hydrochloride represented by the following formula (7) as shown in the following reaction formula. . In the following formulas (6) and (7), X and R ^{2 to} R ⁷ have the same definitions as in the above formula (1), and thus the description thereof is omitted here. In the following reaction formula, a hydrazine compound of the formula: X—NH—NH ₂ may be used instead of the hydrazine hydrochloride represented by the following formula (7).

Further, the azo-boron complex compound of the above (1) is obtained by combining the hydrazone compound of the formula (2) thus obtained and the boron compound of the following formula (8) as shown in the following reaction formula. It can be produced by reaction. In the following formula (8), R ⁹ represents an alkyl group having 1 to 12 carbon atoms, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group, or a halogen atom. represent the atoms are eliminated easily group than that or R ¹ the same as R ^1. Here, “alkyl group”, “aryl group”, “aryl ethenyl group”, “aryl ethynyl group”, “alkoxy group having 1 to 12 carbon atoms”, “aryloxy group” and “halogen atom” Is the same definition as in the above formula (1), and the description is omitted here. Further, ^{R 1} X and ^R 1 to R ⁷ and the following formula (8) in the following formulas (2) are the same as defined in the above formula (1), a description thereof will be omitted.

  In the indwelling needle of the present invention, at least a part of the sheath conductor portion 2 includes a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared rays having a wavelength of 500 nm to 1400 nm, including the above-described near-infrared fluorescent dye. . Here, the arrangement form of the near-infrared fluorescent dye on the sheath conductor portion 2 is not particularly limited. For example, (a) a form that is introduced (included) into or part of the sheath conductor part, and (b) a sheath. Any form such as covering (applying) the surface of at least a part or all of the conductor part may be used. In the following, (a) a configuration in which the sheath conductor portion is introduced (included) in a part or all of the sheath conductor portion, and (b) a configuration in which at least a part or all of the surface of the sheath conductor portion is coated (coated) will be described in detail. In addition, the following demonstrates preferable embodiment of each form, and this invention is not limited to the following form.

[(A) Form Introduced (Included) in Part or All of Sheath Conductor]
A raw material polymer solid or melt is kneaded with a near-infrared fluorescent dye to prepare a polymer composition, and a sheath conductor portion is produced using this polymer composition.

  The polymer to be used is not particularly limited, and a polymer usually used as a material constituting the sheath conductor portion can be used. Specifically, the resin material described in the column of the sheath conductor portion 2 can be suitably used. Of these, polyvinyl chloride, ethylene-tetrafluoroethylene (fluororesin), polyethylene, polypropylene, and silicone resin are preferable from the viewpoints of biocompatibility, durability, and the like. More preferably, polyvinyl chloride, ethylene-tetrafluoroethylene (fluororesin), polyethylene, or polypropylene is used.

  Here, the mixing ratio of the near-infrared fluorescent dye and the polymer is not particularly limited as long as it is a ratio that emits near-infrared fluorescence to a sufficiently visible level when irradiated with near-infrared light having a wavelength of 500 nm to 1400 nm. Specifically, it is preferable that 0.001 to 10.0 parts by weight of the near infrared fluorescent dye is added to 100 parts by weight of the polymer, and 0.01 to 100 parts by weight of the polymer. It is more preferable to add 1 part by weight. If it is such a ratio, when near-infrared rays having a wavelength of 500 nm to 1400 nm are irradiated, near-infrared fluorescence is emitted to such a degree that it can be sufficiently visually recognized, and the strength, flexibility, and moldability of the sheath conductor portion itself. Can be secured.

  Moreover, you may add an additive to the said raw material polymer further. Here, the additive is not particularly limited as long as it does not harm the living body, and an additive usually used for the sheath conductor can be used. Specifically, pigment, dye, reinforcing agent (glass fiber, carbon fiber, talc, mica, viscosity favorite, potassium titanate fiber, etc.), filler (carbon black, silica, alumina, titanium oxide, metal powder, wood powder) , Rice husks, etc.), heat stabilizers, oxidation degradation inhibitors, ultraviolet absorbers, lubricants, mold release agents, crystal nucleating agents, plasticizers, flame retardants, antistatic agents, foaming agents and the like. In addition, the said additive may be used individually by 1 type, or may be used in the form of a mixture of 2 or more types.

  Here, the addition amount of the additive is not particularly limited as long as the desired effect can be achieved, and the same amount as the normal addition amount can be applied. Specifically, the ratio of the additive is preferably 1 to 30 parts by weight with respect to 100 parts by weight of the polymer, and the ratio of 1 to 20 parts by weight with respect to 100 parts by weight of the polymer. Is more preferable.

  Also, the manufacturing method of the sheath conductor part is not particularly limited, and a known method can be applied in the same manner or appropriately modified. Specifically, (A) materials constituting the sheath conductor (polymer), near-infrared fluorescent dye, and, if necessary, raw materials such as additives are put into a kneader such as an extruder and melt-kneaded. Thereafter, a method of molding, (a) a method of premixing the above raw materials, and then charging, melt-kneading and molding in the same manner as above, and (c) supplying the raw materials into a molding machine and molding while melting and mixing The method etc. are mentioned. Here, the apparatus for kneading the raw materials is not particularly limited as long as each component can be kneaded. For example, batch kneaders such as rollers, kneaders, roll mills, super mixers, Henschel mixers, Shugi mixers, vertical granulators, high speed mixers, fur matrices, ball mills, steel mills, sand mills, vibration mills, attritors, Banbury mixers And an extruder, a rotor type twin-screw kneader, and the like. Among these, an extruder is preferably used. Examples of the extruder include a screw extruder such as a single-screw extruder and a twin-screw extruder, an elastic extruder, a hydrodynamic extruder, a ram-type continuous extruder, a roll-type extruder, a gear-type extruder, and the like. Can be mentioned. Among these, a screw extruder, particularly a twin screw extruder is preferable, and a twin screw extruder having one or more vents (deaeration ports) with good deaeration efficiency is more preferable. In the above (a), the mixer that can be used for the preliminary mixing is not particularly limited, and known mixers such as a Henschel mixer, a tumbler, and a disper can be used.

  Moreover, the temperature at the time of melting (melting temperature) is not particularly limited, but is preferably equal to or higher than the glass transition temperature of the material (polymer) constituting the sheath conductor portion. Specifically, the melting temperature is more preferably 10 to 300 ° C. Further, the temperature (kneading temperature) at which the raw materials are kneaded is not particularly limited, but is preferably equal to or higher than the glass transition temperature of the material (polymer) constituting the sheath conductor portion, and the material constituting the sheath conductor portion ( More preferably, it is not less than the glass transition temperature of the polymer) and less than the melting temperature. Specifically, the kneading temperature is more preferably 100 to 250 ° C. When the kneading temperature is in such a range, it is preferable because the material (polymer) constituting the sheath conductor portion is softened and the load on the kneading apparatus can be reduced. Here, the “melting temperature” refers to the end point temperature of the crystal melting endothermic peak that appears during temperature rise measurement by a differential scanning calorimeter (DSC). The “glass transition temperature” refers to a transition temperature obtained from the thermograph in measurement with a differential scanning calorimeter in accordance with JIS-K7121-1987.

  Thereby, a composition in the form of pellets, powders, granules or beads can be obtained.

  Next, the composition obtained above is formed into a sheath conductor portion. Here, the forming method is not particularly limited, and a known method for manufacturing the sheath conductor portion can be applied in the same manner or appropriately modified. Specific examples include extrusion molding, hollow extrusion molding, injection molding, inflation molding, blow molding, extrusion blow molding, injection blow molding, compression molding, press molding, vacuum molding, calendar molding, and foam molding. The molding conditions are not particularly limited, and may be the same as the molding conditions for a general sheath.

[(B) Form in which at least part or all of the surface of the sheath conductor is coated (applied)]
A near-infrared fluorescent dye is dissolved in a suitable solvent to prepare a dye solution, and this dye solution is coated (applied) on a surface of the sheath conductor or a predetermined portion of the lumen lumen.

  The solvent used is not particularly limited as long as it can dissolve the near-infrared fluorescent dye, and is appropriately selected depending on the type of the near-infrared fluorescent dye used. Specifically, halogen-based organic solvents such as chloroform and dichloromethane; aliphatic hydrocarbons such as butane, pentane and hexane; aromatic hydrocarbons such as benzene, toluene and xylene; esters such as ethyl acetate and butyl acetate; Water-insoluble ketones such as isobutyl ketone; ethers such as tetrahydrofuran (THF), butyl ether and dioxane; aliphatic alcohols such as methanol, ethanol and isopropanol; acetonitrile, dimethylformamide (DMF), dimethyl sulfoxide (DMSO), two Examples thereof include carbon sulfide. These solvents may be used alone or as a mixed solvent in which two or more of these solvents are combined.

  The concentration of the near-infrared fluorescent dye in the dye solution is not particularly limited. In consideration of emission intensity of near-infrared fluorescence (ease of visual recognition), stability, low deterioration, etc., preferably 0.001 to 10.0% by weight, more preferably 0.01 to 1.0% by weight. It is. The amount of coating (application) of the near-infrared fluorescent dye on the surface of the sheath conductor or the lumen lumen is not particularly limited, and varies depending on the type of the near-infrared fluorescent dye used. Specifically, considering the emission intensity (ease of visual recognition) of near-infrared fluorescence, the coating (coating) amount is such that the film thickness is 1 to 5000 μm, more preferably 1 to 1000 μm. preferable. If it is the said range, when irradiating near infrared rays with a wavelength of 500 nm-1400 nm, near infrared fluorescence can be emitted to such an extent that it can fully be visually recognized. In addition, it is preferable in terms of workability (e.g., ease of application) and production efficiency that a desired amount of near-infrared fluorescent dye can be applied in one application, but if necessary, a desired amount of The coating process may be repeated a plurality of times until the near-infrared fluorescent dye can be coated. However, even if it is out of the above range, it can be sufficiently utilized as long as it does not affect the operational effects of the present invention.

  The coating method is not particularly limited, and a known coating method can be used. Specifically, dipping method (dipping method), coating / printing method, spraying method (spray method), spin coating method, mixed solution impregnation sponge coating method, spray device, bar coater, die coater, reverse coater, comma coater And a method of coating (coating) using a coating apparatus such as a gravure coater, spray coater, doctor knife or the like.

  After the application, the near-infrared fluorescent dye can be coated (applied) on the surface of the sheath conductor or the lumen lumen by drying the application layer. Here, the drying method is not particularly limited, and for example, it can be dried by heating. The drying temperature is not particularly limited as long as the solvent is sufficiently evaporated and the near-infrared fluorescent dye is applied to the surface of the sheath conductor portion. For example, the drying temperature is preferably 10 to 250 ° C, more preferably 10 to 100 ° C. Also, the drying time is not particularly limited as long as the solvent is sufficiently evaporated and the near-infrared fluorescent dye is applied to the surface of the sheath conductor portion. For example, 5 minutes to 24 hours is more preferable. Although it does not restrict | limit especially as a heating means (apparatus), For example, oven, a dryer, etc. can be utilized. The drying step may be performed under reduced pressure, normal pressure, or increased pressure, but is preferably performed under normal pressure in consideration of the ease of operation.

  In this way, a coating layer may be further provided after coating (applying) the near-infrared fluorescent dye on a part or all of the surface of the sheath conductor portion. By providing the coating layer in this way, the near-infrared fluorescent dye coating (coating layer) is peeled off even when the coating film (coating layer) of the near-infrared fluorescent dye is in contact with the biological lumen wall. (Detachment) hardly occurs or does not occur. Here, the coating layer is not particularly limited, but may be formed using a material constituting the sheath conductor portion.

  In the indwelling needle of the present invention, the inner needle can be manufactured by a known method. In addition, as a method of covering at least a part of the surface of the tip of the inner needle with a material containing a near infrared fluorescent dye, a method of forming a layer containing a near infrared fluorescent dye on the sheath conductor is the same. Can be applied.

  In the indwelling needle of the present invention, the sheath base and the inner needle base can be manufactured by a known method. Specifically, JP 2012-71052 A, JP 2012-29974 A, JP 2012-5647 A, JP 2011-120760 A, JP 2011-45544 A, JP 2011-11000 A. Reference is made to Japanese Patent Publication No. JP-A-2010-11914, JP-A 2009-233007, and the like.

  The indwelling needle of the present invention as described above can visually recognize the indwelling needle by irradiating near infrared rays with a selected wavelength, and there is no problem of exposure due to X-rays or the like. For this reason, the burden on the patient and the operator due to the X-ray exposure can be significantly reduced. Moreover, since near infrared rays excellent in the permeability of the living body are used for visualizing the indwelling needle, the indwelling needle introduced into the living body can be confirmed noninvasively and satisfactorily. In addition, by irradiating near-infrared rays, it is also possible to check the running of the vasculature, so the position of the indwelling needle in the blood vessel can be visually confirmed, and the indwelling position of the indwelling needle can be reliably confirmed. can do. Furthermore, in treatments such as cancer chemotherapy, which are frequently repeated in venous vessels, the vasculatable vessel is localized due to occlusion of the vessel to which the drug can be administered. By using an indwelling needle containing a near-infrared fluorescent dye that emits external fluorescence, the indwelling position of the indwelling needle can be made more reliable.

  Therefore, the present invention also provides an indwelling needle of the present invention, a light source for irradiating near infrared light having a wavelength of 500 nm to 1400 nm, a camera for receiving near infrared fluorescence emitted by a near infrared fluorescent dye upon the irradiation, and the above The present invention relates to an indwelling needle position confirmation system having a monitor for confirming an image captured by a camera.

  Hereinafter, a procedure for indwelling in a patient's blood vessel using the indwelling needle of the present invention will be described with reference to FIGS. 4 and 5. In addition, the following procedure demonstrates preferable embodiment, and this invention is not limited to the following usage method. The indwelling needle of the present invention can be used in the same manner as indwelling a normal indwelling needle in a blood vessel. In the following description, the puncture instrument 100 including the indwelling needle 1 of the present invention shown in FIG. 1 is used in FIGS. 4 and 5. Needless to say, other forms of the puncture tool 100 are used instead of the indwelling needle shown in FIG. An indwelling needle may be used.

  4A shows a state in which the needle tip of the indwelling needle 1 of the puncture device 100 is inserted into the skin 6, FIG. 4B shows a state in which the needle tip portion 41 of the inner needle 4 has reached the blood vessel 7, and FIG. FIG. 4C is a diagram showing a state in which the tip of the needle tip of the sheath conductor portion 2 has reached the blood vessel 7, and FIG. 4D is a diagram showing a state in which the inner needle 4 is removed from the sheath conductor portion 2 and the sheath conductor portion 2 is indwelled. is there.

  FIG. 5 is a schematic diagram showing a system for confirming that an indwelling needle is placed in a target blood vessel using the indwelling needle of the present invention.

  First, as shown in FIG. 4, a medical staff such as a doctor grasps the puncture device 100 including the indwelling needle 1 and punctures it toward the blood vessel (vein) of the patient, and gradually moves the indwelling needle 1 toward a desired site. The distal end portion advances while cutting through the body tissue 42.

  On the other hand, at the same time that the indwelling needle 1 is punctured into the patient, the light source 61 is arranged to irradiate the vicinity of the puncture site of the patient with the near infrared ray 60 having a specific wavelength.

  Then, the near infrared fluorescence emitted from the portion including the near infrared fluorescent dye of the sheath conductor portion 2 is received by the camera (light receiving element) 63, so that the portion including the near infrared fluorescent dye of the indwelling needle 1 is displayed on the display 62. Is displayed as an image 64. Specifically, the display 62 displays a portion of the indwelling needle 1 that includes a near-infrared fluorescent dye and a vein. Accordingly, it can be confirmed from the display 62 whether or not the indwelling needle 1 has reached the blood vessel (vein) of the patient.

  As a result, the vicinity of the tip of the inner needle 4 is clearly displayed as an image on the display 62, and the position of the inner needle 4 constituting the indwelling needle 1 is confirmed with high accuracy.

  Then, the doctor or the like moves the indwelling needle 1 while confirming the display 62 and guides the inner needle 4 to a desired blood vessel of the patient. At this time, the indwelling needle 1 is advanced while appropriately pulling the plunger 11 of the syringe 10.

  When the indwelling needle 1 is correctly punctured into the blood vessel, blood is introduced into the syringe body 10 through the connection port of the syringe 10 and flashback occurs.

  When it can be confirmed that the sheath conductor portion 2 has reached the blood vessel 7, the inner needle 4 is moved together with the inner needle base portion 5 and the syringe 10 with the sheath conductor portion 2 placed in the target blood vessel 7. To be removed.

  When the target blood vessel 7 is a peripheral vein, the infusion set is connected to the sheath base opening 32 of the sheath base 3 to start the infusion. On the other hand, when the target blood vessel 7 is a deep blood vessel 7 such as a subclavian vein and a central venous catheter is placed, a guide wire called an advancer is accommodated in the sheath base opening 32 of the sheath base 3. Connect the guide wire supply and introduce the guide wire to the central vein. Then, leaving the guide wire in the blood vessel 7, the sheath 2 is removed from the blood vessel 7 together with the sheath base 3 and the guide wire supply tool, and then a central venous catheter is inserted into the blood vessel 7 along the guide wire.

  At this time, in the indwelling needle 1 of the present invention, whether or not the indwelling needle 1 is correctly punctured into the blood vessel can be confirmed using the system shown in FIG.

  The indwelling needle 1 of the present invention is indwelled when a near-infrared light (near-infrared light) 60 is irradiated from a light source 61 toward a site of a blood vessel 7 of a patient inserted at a depth of 5 mm to 20 mm below a tissue surface. The needle 1 emits near infrared fluorescence.

  The camera 63 can pick up an image of the portion of the indwelling needle 1 containing the near-infrared fluorescent dye by receiving near-infrared fluorescence emitted by the near-infrared fluorescent dye of the indwelling needle 1 with a light receiving element. That is, the near-infrared fluorescence emitted from the near-infrared fluorescent dye of the indwelling needle 1 passes through the tissue of the patient's human body, and this is received by the camera 63 to photograph the indwelling needle 1. In addition, the contours of the patient's body are photographed at the same time.

  The image picked up by the camera 63 may be monochrome or color. Further, the camera 63 may be one in which a light source 61 is annularly provided around the lens. Thereby, it becomes possible to image the indwelling needle 1 more appropriately.

  The display 62 projects the image 64 of the indwelling needle 1 photographed by the camera 63 in monochrome or color on the projection surface. A medical worker such as an operator can confirm the position, posture, orientation, and the like of the indwelling needle 1 in the blood vessel 7 of the patient by looking at the image 64 of the indwelling needle 1 displayed on the display 62.

  In the present invention, the near infrared ray 60 irradiated from the outside of the patient's body is an infrared ray having a wavelength of 500 to 1400 nm, which absorbs moisture and the like relatively little. The near infrared wavelength range is preferably 530 to 1390 nm, more preferably 540 to 1380 nm, still more preferably 550 to 1350 nm, and particularly preferably 600 to 1300 nm. If it is near infrared of the said wavelength range, the structure | tissue deep part to a maximum of 2 cm is possible. Furthermore, hemoglobin is contained in the blood flowing through the blood vessels. This hemoglobin can read the vascular pattern with the intensity of reflected light by absorbing near infrared rays.

  During the medical practice with this injection needle, near infrared rays 60 are emitted from the light source 61 toward the affected area from above the skin 6, whereby the fluorescence emitted from the injection needle under the patient's skin is received by the camera 63, and as a result. The whole image of the blood vessel 7 that is the injection needle and the vein is displayed on the display 62 in real time. In this case, reduced hemoglobin in venous blood absorbs a wavelength component of 600 nm to 800 nm in the near infrared, so that the vein is projected in black on the display 62 and the surface of the injection needle that is the indwelling needle 1 is emitted. Since the near-infrared fluorescent color is transmitted to the outside of the skin, the near-infrared fluorescent color is projected on the display 62.

  Specifically, as shown in FIG. 6, the fluorescent material-containing portion 70 of the indwelling needle and the blood vessel 71 are displayed on an image 64 on the display 62.

  Thus, the surgeon and the like do not use X-rays or ultrasonic waves, and the surgeon or the like does not use X-rays while checking the positional relationship between the blood vessel 7 and the injection needle from above the patient's skin 6. The needle can be inserted into the vein simply and accurately.

  According to the test by the present inventors, it was possible to visually recognize the injection needle and the blood vessel even at a depth of about 2 cm subcutaneously.

  In addition, although the inner needle 4 according to the embodiment is a hollow needle, it may be a solid needle that does not secure the blood vessel 7.

  In the embodiment, the blood inflow portion is constituted by the groove portion 42 provided on the outer surface of the inner needle 4, but the sheath 2 and the inner needle are formed by a hole portion that communicates the outer surface and the inner surface of the sheath 2. 4, that is, a blood inflow portion into which blood flows into the gap portion 21 may be configured, or a blood inflow portion may be configured by both the groove portion 42 and the hole portion.

  As described above, according to the present invention, it is possible to provide an indwelling needle that can surely visually recognize the position of the indwelling needle in the blood vessel with a simple structure. However, as described above, the present invention relates to the embodiment. It is not limited to the indwelling needle 1.

  Moreover, in the said method, the light source 61 which irradiates the near infrared ray 60 of a specific wavelength, the camera 63 which light-receives the near-infrared fluorescence which a near-infrared fluorescent dye emits by the said infrared irradiation, and the image of the indwelling needle | hook image | photographed with the said camera 63 Although the device (system) for visually recognizing the indwelling needle having the display 62 for confirming 64 is used, the device (system) for visually recognizing the indwelling needle is not particularly limited to the above, and is a known device (system). Can be used. For example, an imaging apparatus that captures and images near-infrared fluorescence emitted by an excited near-infrared fluorescent dye is included in the constituent elements. The imaging device is capable of capturing near-infrared fluorescence, and is provided with an objective lens that forms an image of the captured near-infrared fluorescence and a lens that expands the image formed by the objective lens. The apparatus may include an infrared transmission filter that does not transmit the elastically scattered light of the laser. The infrared transmission filter is not particularly limited as long as it does not transmit the elastic scattered light of the laser used. As long as the above conditions are satisfied, the material of the infrared transmission filter is not limited, and examples of the material include glass, acrylic, plastic, and hard vinyl chloride. The device may include an infrared scope. The infrared scope is not particularly limited as long as it can detect infrared imaging and can project infrared imaging. An example is an infrared scope developed for medical devices. The infrared scope may include a photographing device for photographing an image projected on the infrared scope. The photographing apparatus is not particularly limited, and examples thereof include a CCD camera developed for research equipment such as a microscope, a commercially available still camera, and a digital camera. An adapter or a hood may be installed between the infrared scope and the camera so that focusing can be performed more easily. When using a still camera, an infrared film is used. The video to be taken may be a still image or a video. A display device that can display an image captured by the imaging device can be connected to the imaging device. The display device is not particularly limited, and examples thereof include general cathode ray tube monitors and liquid crystal monitors. When a personal computer monitor is used as the display device, it is possible to connect to the monitor after passing through the personal computer body. A video recording device capable of recording video can be connected to at least one of the photographing device and the display device. When the video recording device is connected to the photographing device, the still image or the moving image photographed by the photographing device is recorded, and when the video recording device is connected to the display device, the display device displays it. Record still images or movies. The recording method is not particularly limited, and examples thereof include a method using a medium capable of recording image information magnetically, optically, electrically, and magneto-optically, and a device for recording on the medium. Specific examples of media include hard disk, magnetic tape, compact flash (registered trademark) memory, MO disk (magnet optical disk), CDR (writable CD (compact disk)), CDRW (rewritable CD). ), DVDR (writable DVD (digital video disc)), DVDRW (rewritable DVD), BDR, BDRW, and the like. As a device for recording on a medium, a device suitable for the medium is used.

  Alternatively, the device for visually recognizing the indwelling needle includes a light source unit that emits near-infrared light, and an imaging unit that receives reflected light and / or scattered light from the near-infrared fluorescent dye-containing unit of the indwelling needle emitted from the light source unit. It may have. In this apparatus, near infrared rays emitted from the light source unit are reflected and / or scattered by the sheath conductor portion containing the near infrared fluorescent dye, and the reflected light and / or scattered light is received by the imaging unit. For this reason, the light source unit and / or the imaging unit may include an exposure unit that transmits near infrared rays having a wavelength in the range of 500 nm to 1400 nm. Thereby, in a light source part and an imaging part, since the near infrared ray of the said limited wavelength range is radiated | emitted or light-received, an indwelling needle can be visually recognized more favorably. In addition to or instead of the exposure filtering unit, the light source unit and / or the imaging unit may include a polarizing unit that transmits near infrared rays having a polarization plane in a desired direction. Thereby, since the light source part or the imaging part emits or receives only near-infrared light having a polarization plane in a desired direction transmitted by the polarizing part, the indwelling needle can be visually recognized better. In addition to or instead of the above, the apparatus may include an output unit that displays or outputs a signal of data relating to reflected light and / or scattered light received by the imaging unit as an image. As a result, the output unit can display or signal output data relating to the reflected light and / or scattered light received by the imaging unit as an image. In this case, the apparatus stores an optical information storage unit that stores data relating to reflected light and / or scattered light received by the imaging unit in a readable manner, and data relating to reflected light and / or scattered light from the optical information storage unit. And an analysis unit that reads out and analyzes the frequency spectrum and / or luminance distribution of the reflected light and / or scattered light, and the output unit displays data on the frequency spectrum and / or luminance distribution obtained by the analysis unit as an image. Display or signal output. The optical information storage unit stores the data related to the reflected light and / or scattered light received by the imaging unit in a readable manner, and the analysis unit reads the data related to the reflected light and / or scattered light from the optical information storage unit and reflects the data. The frequency spectrum and / or luminance distribution of the light and / or scattered light can be analyzed, and the output unit can display or signal output data regarding the frequency spectrum and / or luminance distribution obtained by the analyzing unit as an image.

  The near-infrared light irradiating means and the light receiving means are not particularly limited. For example, a light emitting diode may be used as the irradiating means, and a light receiving means may be configured as a photodiode. Since the light-emitting diode and the photodiode are small and available at low cost, the technique can be performed with small size and low cost. Moreover, the optical axis of the light irradiated by the light irradiation unit and the optical axis of the light received by the light receiving unit may be arranged on the same axis. Since the shortest path length of the light until the irradiated light reaches the light receiving means is shortened, it becomes easy to reach the light receiving means even if the intensity of the irradiated light is weak, and the detection sensitivity for weakly irradiated light is increased. As a result, the information on the shallower portion becomes accurate and the obtained biological density measurement value becomes accurate, so that a highly accurate density measuring device can be realized.

DESCRIPTION OF SYMBOLS 1 Indwelling needle 2 Sheath conductor part 2a Sheath conductor part visualized by near-infrared fluorescent dye 3 Sheath base part 4 Inner needle 4a End part of inner needle visualized by near-infrared fluorescent dye 5 Inner needle base part 6 Skin 7 Blood vessel 10 Syringe 11 Plunger 21 Gap portion 31 Through hole portion 32 Sheath base portion opening portion 33 Sheath base portion space 41 Needle tip portion 42 Groove portion 51 Protruding portion 52 Inner needle base portion space 53 Protruding portion opening portion 54 Communication hole 60 Near infrared ray 61 Light source 62 Display 63 Camera 64 Image 70 Near-infrared fluorescent dye-containing portion of indwelling needle 71 Blood vessel 100 Puncture device.

Claims (5)

A hollow sheath conductor,
A sheath base portion fixed to the base end portion of the sheath conductor portion and configured by a cylindrical member;
An indwelling needle having
An indwelling needle in which at least a part of the sheath conductor includes a near-infrared fluorescent dye that emits near-infrared fluorescence when irradiated with near-infrared light having a wavelength of 500 to 1400 nm. The near-infrared fluorescent dye has the following formula (1):
X represents an unsubstituted or substituted aryl group or an unsubstituted or substituted heteroaryl group;
Each R ¹ independently represents an alkyl group having 1 to 12 carbon atoms, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group, or a halogen atom; Alternatively, one R ¹ represents —O—C (═O) — and is bonded to X to form a 6-membered ring, and the other R ¹ represents an alkyl having 1 to 12 carbon atoms. A group, an aryl group, an arylethenyl group, an arylethynyl group, an alkoxy group having 1 to 12 carbon atoms, an aryloxy group or a halogen atom;
R ² and R ³ are connected to each other to —O—, —S—, or —N (R ⁸ ) — (wherein R ⁸ represents a hydrogen atom or an alkyl group having 1 to 12 carbon atoms). And R ⁴ and R ⁵ represent a hydrogen atom, or R ⁴ and R ⁵ are linked together to —O—, —S—, or —N (R ⁸ ) — (where R 4 ⁸ represents a hydrogen atom or an alkyl group having 1 to 12 carbon atoms), and R ² and R ³ represent a hydrogen atom;
R ⁶ and R ⁷ each independently represent a hydrogen atom, an alkyl group having 1 to 12 carbon atoms, an unsubstituted or substituted aryl group, or an unsubstituted or substituted heteroaryl group. ;
The substituent of the aryl group or heteroaryl group includes a nitro group, a cyano group, an alkoxycarbonyl group having 2 to 13 carbon atoms, an alkyl group having 1 to 12 carbon atoms, a formula: —NH (R ⁹ ) (wherein , R ⁹ represents an alkyl group having 1 to 12 carbon atoms), a mono (alkyl) amino group, a formula: —N (R ⁹ ) ₂ (wherein R ⁹ independently represents the number of carbon atoms A di (alkyl) amino group, a carboxyl group, a hydroxyl group or an alkoxy group having 1 to 12 carbon atoms.
Or an azo-boron complex compound represented by the following formula (2):
However, X and R < ² > -R < ⁷ > are the definitions similar to the said Formula (1),
The indwelling needle of Claim 1 containing the hydrazone compound shown by these.   At least a part of the sheath conductor is formed of a material containing the near-infrared fluorescent dye, or at least a surface of the sheath conductor is covered with a material containing the near-infrared fluorescent dye. Item 3. The indwelling needle according to item 1 or 2. The near-infrared fluorescent dye has the following formulas (3) to (5):
However, X and R < ¹ > -R < ⁷ > are the definitions similar to the said Formula (1),
The indwelling needle of any one of Claims 1-3 containing the azo-boron complex compound shown by either. Further comprising an inner needle inserted through the hollow interior of the sheath conductor portion,
The indwelling needle according to any one of claims 1 to 4, wherein at least a part of the surface of the tip of the inner needle is coated with a material containing the near-infrared fluorescent dye.