The present disclosure relates to a hollow needle.
Patent Document 1 discloses an electrode needle to be punctured into a living body, including a columnar or tubular core, an electrode formed in the core, an insulation part where the electrode is covered with insulative material, and an electrode window part where the electrode or a sensing layer formed on the electrode is exposed. With Patent Document 1, it is possible to measure information of glucose, by puncturing the electrode needle of about 5 mm length into subcutaneous tissue.
When obtaining information inside of a living body as mentioned above, a dedicated tool or device is used. Such a dedicated tool or device obtains only information inside of the living body. For this reason, after performing the procedure for obtaining information inside of the living body, it is necessary to separately perform a procedure such as injection of a drug solution into the living body or extraction of body fluids such as blood from inside the living body, using a tool separate from the dedicated tool or device. The damage to the living body tends to increase as the number of such procedures to the living body increases.
On the other hand, the needle used in puncturing of the living body may have an opening for injecting a drug solution into the living body, and for extracting blood. Upon puncturing this type of hypodermic needle to a living body, it is desirable to configure so as to be able to recognize the position of the opening of the hypodermic needle, or the position of the tip from outside of the living body.
An object of the present disclosure is to provide a hollow needle enabling procedures such as injection of a drug solution into a living body and extraction of body fluids from the living body, and enabling recognition of the position of an opening or the position of the tip within the living body from outside the living body.
A hollow needle according to a first aspect of the present invention includes: a needle body made of an electrically conductive material, forming a cylindrical shape, and including a shaft part, a tip part connected with the shaft part, and an opening for discharging or drawing in a liquid, wherein a cavity communicating between the shaft part and the opening is formed inside; and an annular insulating film made of an electrically insulative material, which exposes the opening and at least part of the tip part, and coats at least part of an outer circumferential surface of the shaft part.
According to a second aspect of the present invention, in the hollow needle as described in the first aspect, at least part of an outer circumferential surface of the tip part is electrically conductive, and is electrically connected to the shaft part.
According to a third aspect of the present invention, in the hollow needle as described in the first or second aspect, a maximum value for a step height h1 from the outer circumferential surface of the shaft part until a surface of the insulating film at an end position on a side of the tip part of the insulating film is 200 μm or less.
According to a fourth aspect of the present invention, the hollow needle as described in any one of the first to third aspects further includes, at an end on a side of the tip part of the insulating film, a gradually decreasing part for which a film thickness of the insulating film gradually decreases toward the tip part.
According to a fifth aspect of the present invention, in the hollow needle as described in any one of the first to fourth aspects, the needle body includes a recessed part with a decreased thickness on at least part of the outer circumferential surface of the shaft part, and the insulating film is accommodated in the recessed part of the shaft part.
According to a sixth aspect of the present invention, in the hollow needle as described in any one of the first to fifth aspects, a surface roughness Ra of a coated surface of the shaft part which is coated with the insulating film is more than 0 μm and 1 μm or less.
According to a seventh aspect of the present invention, in the hollow needle as described in any one of the first to sixth aspects, a surface roughness Ra of an uncoated surface of the shaft part which is not coated with the insulating film is smaller than a surface roughness Ra of the coated surface of the shaft part which is coated with the insulating film.
According to an eighth aspect of the present invention, in the hollow needle as described in any one of the first to seventh aspects, the shaft part slopes or bends toward the tip part, and the opening is formed at the tip part.
According to a ninth aspect of the present invention, in the hollow needle as described in any one of the first to eighth aspects, the insulating film is configured from a resin having an electrical insulating property.
According to a tenth aspect of the present invention, in the hollow needle as described in any one of the first to ninth aspects, the insulating film is configured from a polyimide resin or a fluorocarbon resin.
According to an eleventh aspect of the present invention, in the hollow needle as described in any one of the first to tenth aspects, the needle body is configured from a metal.
According to a twelfth aspect of the present invention, in the hollow needle as described in any one of the first to eleventh aspects, the needle body is configured from a stainless steel, a titanium alloy or a cobalt/molybdenum-containing alloy.
According to the present disclosure, it is possible to provide a hollow needle enabling procedures such as injection of a drug solution into a living body and extraction of body fluids from the living body, and enabling recognition of the position of an opening or the position of the tip within the living body from outside the living body.
Hereinafter, an embodiment will be explained in detail.
As shown in
The hollow needle 1 has the needle body 10 and the insulating film 20. The shaft part 11 constituting the needle body 10 forms a cylindrical shape, and extends along the longitudinal direction of the hollow needle 1. An opening 11b on the base end side (hereinafter simply called opening lib) is provided to the base end 11a of the shaft part 11. The base end 11a of the shaft part 11 corresponds to the base end of the hollow needle 1. The opening 11b of the base end 11a of the shaft part 11 corresponds to the opening of the base end of the hollow needle 1. An opening 11d on the tip side (hereinafter simply called opening 11d) is provided to a tip 11c of the shaft part 11.
The shaft part 11 connects with the tip part 12. A base end 12a of the tip part 12 is integrally coupled to the tip 11c of the shaft part 11. An opening 12d on the base end side (hereinafter simply called opening 12b) is provided to the base end 12a of the tip part 12. The opening 11d of the tip 11c of the shaft part 11 communicates with the opening 12d of the base end 12a of the tip part 12. The tip part 12 assuming a cylindrical shape is formed so as to extend along the longitudinal direction of the hollow needle 1. The tip 12c of the tip part 12 corresponds to the tip of the hollow needle 1.
The opening 16 is provided to the needle body 10. The opening 16 discharges or draws in a liquid. Herein, as shown in
Inside of the needle body 10, a cavity S communicating between the shaft part 11 and the opening 16, and extending in the longitudinal direction of the hollow needle 1 is formed. The cavity S provided inside of the needle body 10 communicates from the opening 11b of the base end 11a of the shaft part 11 until the opening 16. A drug solution and body fluid injected or extracted by the hollow needle 1 flows in the cavity S.
The needle body 10 consists of an electrically conductive material. In other words, the shaft part 11 and the tip part 12 constituting the needle body 10 consist of an electrically conductive material. It should be noted that it may be configured so as to plate the needle body 10 with an electrically conductive material.
The needle body 10 is preferably configured from metal, and thereamong, it is more preferably configured from a stainless steel, a titanium alloy or a cobalt/molybdenum-containing alloy. If the needle body 10 is configured from metal, the electrical conductivity and the mechanical strength of the needle body 10 will be favorable, and the production of the needle body 10 will be easy. Furthermore, if the needle body 10 is configured from a stainless steel, a titanium alloy or a cobalt/molybdenum-containing alloy, in addition to the above-mentioned properties, the long-term stability such as rust prevention of the needle body 10 will improve.
The insulating film 20 consisting of an electrical insulative material exposes the opening 16 and at least part of the tip part 12, and annularly coats at least part of the outer circumferential surface 11e of the shaft part 11. As mentioned above, the tip part 12 consists of an electrically conductive material. The opening 16 and at least part of the outer circumferential surface of the tip part 12 are not coated with the insulating film 20. The opening 16 and at least part of the outer circumferential surface of the tip part 12 have electrical conductivity, and are electrically connected to the shaft part 11.
The insulating film 20 is preferably configured from a resin having electrical insulating property, and thereamong, it is more preferably configured from a polyimide resin or a fluorocarbon resin. If the insulating film 20 is configured from a resin having electrical insulating property, the electrical insulating property of the insulating film 20 will be favorable, and the film formation of the insulating film 20 on the needle body 10 is easy. Furthermore, when the insulating film 20 is configured from a polyimide resin or a fluorocarbon resin, in addition to the above-mentioned characteristics, the frictional coefficient of the surface of the insulating film 20 declines, and the mechanical strength of the insulating film 20 improves.
Regarding the average film thickness of the insulating film 20, the lower limit value is preferably 0.1 μm or more, more preferably 1 μm or more, and even more preferably 5 μm or more, and the upper limit value is preferably 100 μm or less, more preferably 30 μm or less, and even more preferably 10 μm or less. If the average film thickness of the insulating film 20 is 0.1 μm or more, the electrical insulating property of the insulating film 20 will be favorable. If the average film thickness of the insulating film 20 is 100 μm or less, the film formation of the insulating film 20 will be easy, and the outside diameter dimension in the radial direction of the hollow needle 1 will be small; therefore, it is possible to insert the hollow needle 1 smoothly into a living body.
For the length dimension in the longitudinal direction of the hollow needle 1, the lower limit value is preferably 15 mm or more, more preferably 20 mm or more, and even more preferably 25 mm or more, and the upper limit value is preferably 100 mm or less, more preferably 55 mm or less, and even more preferably 35 mm or less. If the length dimension of the hollow needle 1 is 15 mm or more, it is possible to easily insert the hollow needle 1 to the desired depth in the living body. If the length dimension of the hollow needle 1 is 100 mm or less, the handling property of the hollow needle 1 will be favorable.
For the outside diameter dimension in the radial direction of the hollow needle 1, the lower limit value is preferably 700 μm or more, more preferably 800 μm or more, and even more preferably 900 μm or more, and the upper limit value is preferably 1300 μm or less, more preferably 1100 μm or less, and even more preferably 1000 μm or less. If the outside diameter dimension of the hollow needle 1 is 700 μm or more, the hollow needle 1 can inject and extract a sufficient amount of drug solution or body fluid, and it is possible to raise the safety during false puncture. If the outside diameter dimension of the hollow needle 1 is 1300 μm or less, the lateral rigidity of the hollow needle 1 improves, and it is possible to linearly insert without bending, and possible to smoothly insert into a living body.
For the hollow needle 1 having such a needle body 10 and an insulating film 20, when voltage is applied between the outer circumferential surface 11e of the shaft part 11 and the outer circumferential surface of the tip part 12 which are not coated with the insulating film 20, electrical current flows between the shaft part 11 and the tip part 12 of the needle body 10, without flowing in a portion of the insulating film 20 coating the shaft part 11.
As shown in
In the case of the coated surface 13a of the shaft part 11 being roughened within the above-mentioned range of surface roughness Ra, from the viewpoint of an adhesion improvement of the insulating film 20, at least part of the coated surface 13a is preferably roughened, and the entirety of the coated surface 13a is more preferably roughened as shown in
As shown in
In the insulating film 20, the surface roughness Ra of an area abutting the coated surface 13a of the shaft part 11 coated with the insulating film 20 is preferably more than 0 μm and 1 μm or less. If the surface roughness Ra of this area of the insulating film 20 is within the above-mentioned range, the adhesion property of the insulating film 20 improves.
Next, a use example of the hollow needle 1 of the embodiment will be explained.
To the hollow needle 1 inserted into a living body 30, an electric signal is input via the connection wire 41 from a signal input unit provided to the detection device for the hollow needle. The electric signal inputted to the hollow needle 1 flows toward the tip part 12 from the shaft part 11 of the needle body 10. The electric signal does not flow to the insulating film 20. The electric signal flowing to the tip part 12 is received by a receiver provided to the detection device 40 for the hollow needle, as a position information of the tip part 12. For this reason, the detection precision of the tip part 12 of the hollow needle 1 is favorable. Then, the injection of a drug solution can be performed by the hollow needle 1 reaching the objective location.
To the hollow needle 1 inserted in the living body 30, an electric signal is input via the connection wire 51 from the signal input unit provided to the detection device 50 for the implant device. The electric signal inputted to the hollow needle 1 flows from the needle body 10 toward the implant device 52. The electric signal flowed to the implant device 52 is received as a signal that the hollow needle 1 was contact with the implant device 52, by a receiver provided to the detection device 50 for implant device, via a transmitter provided to the implant device 52. For this reason, for the detection device 50 for implant device, the detection accuracy of contact between the hollow needle 1 and the implant device 52 becomes favorable. Then, the injection of a drug solution can be performed by the hollow needle 1 reaching the implant device 52. In addition, the hollow needle 1 is connected with a syringe via a predetermined connector (for example, connector of an international standard (ISO (IEC) 80369 series)).
The Huber-pointed needle 2 has a shaft part 2a in which a base end 11a is inserted in a tube 60 through which a drug solution or the like flows, and which extends within a boundary part 62 of a pair of vane parts 61; and a tip part 2b bending and extending. Herein, a sequence when puncturing the Huber-pointed needle 2 to the skin will be explained. A practitioner pinches the vane parts 61 of the Huber-pointed needle 2 to bring together the top surfaces 61b to close. Next, the practitioner punctures the Huber-pointed needle 2 to the skin while maintaining this closed state. Then, the practitioner, after puncturing the Huber-pointed needle 2 to the skin, opens so that the bottom surfaces 61a of the vane parts 61 contact the skin in order to secure the fixing to the skin, and fixes the top surfaces 61b of the vane parts 61 to the skin with adhesive tape or the like. As the material constituting the vane part 61, silicone or the like can be exemplified considering the proper balance of strength and flexibility. In the pair of vane parts 61, the through holes 63 are provided at corresponding positions of each. Protrusions 64 inserting into the through hole 63 of each other upon closing the vane parts 61 are provided on the top surfaces 61b of the pair of vane parts 61. When respectively fitting each protrusion 64 to the through hole 63 of the other, it is possible to maintain the state in which the vane parts 61 are closed. When using such a hollow needle 1a together with the detection device 40 of
According to the above explained embodiment, in the hollow needle 1, the electric signal flows only to the needle body 10, without flowing to a portion of the insulating film 20 coating the shaft part 11. In addition, the hollow needle 1 charges the drug solution from the opening 11b of the base end 11a of the shaft part 11, and can inject the drug solution from the opening 16. In addition, the hollow needle 1 extracts the body fluid such as blood inside of the living body from the opening 16, and can extract the body fluid from the opening 11b of the base end 11a of the shaft part 11. For this reason, the hollow needle 1 having the needle body 10 and the insulating film 20 is able to deal with injection of a drug solution into a living body or extraction of a body fluid from inside a living body, and enables recognition of the position of the opening of the needle in the living body or the position of the tip from outside the living body.
It should be noted that the above-mentioned embodiment shows an example in which the tip 11c of the shaft part 11 and the base end 12a of the tip part 12 are integrally coupled, as shown in
In addition, as shown in
In addition, as shown in
In addition, the recessed part 14 may not necessarily be annular. For example, as shown in
In addition, as shown in
In addition,
Although an embodiment has been explained above, the present invention is not to be limited to the above-mentioned embodiment, and includes any mode encompassed by the gist and claims of the present disclosure, and can be modified in various ways within the scope of the present disclosure.
Number | Date | Country | Kind |
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2020-041995 | Mar 2020 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2021/001306 | 1/15/2021 | WO |