Patent Application
20240123185
The art disclosed herein relates to a resin-coated wire and a drug solution injection device.
As a drug solution injection device for injecting a drug solution into the body of a patient, a drug solution injection device is known which includes an outer tube having a hollow into which an inner tube having a puncture needle at a distal end is inserted to inject a drug solution from the puncture needle into the body of a patient via a hollow of the inner tube (see, e.g., Patent Literature 1).
Another type of drug solution injection device is a drug solution injection device capable of moving wire forward for a predetermined distance inside a drug solution-containing lumen of a catheter containing a drug solution, and thereby discharging a predetermined amount of the drug solution from a distal end of the catheter. Such a type of drug solution injection device enables accurate control of the discharge amount of a drug solution, as well as reduction of loss of a drug solution.
However, a drug solution injection device having this configuration have a problem in that when a bubble is mixed in a drug solution contained in a drug solution-containing lumen of a catheter, the bubble may be administered into an affected area of a patient together with the drug solution.
The art disclosed herein provides a solution for the problem described above.
The art disclosed herein can be achieved e.g., as the following embodiments.
(1) The resin-coated wire disclosed herein is capable of moving forward inside a drug solution-containing lumen of a catheter containing a drug solution, and thereby pushing out the drug solution from a distal end of the catheter. The resin-coated wire includes a wire, and a coating made of resin coating the wire. The coating includes a distal end coating and a proximal end coating. The distal end coating is formed of a first resin material and coats a first part, which is a distal end portion of the wire. The proximal end coating is formed of a second resin material and coats a second part adjacent to a proximal end side of the first part of the wire. The first resin material has a higher affinity for water than the second resin material.
In the resin-coated wire, a resin material for forming a distal end coating has a higher affinity for water than a resin material for forming a proximal end coating. In other words, a bubble in water (in a drug solution) is easily attached so as to extend on a surface of the proximal end coating, while the bubble poorly extends and insufficiently attaches onto a surface of the distal end coating. Hence, even when a bubble is mixed in a drug solution contained in a drug solution-containing lumen of a catheter, the bubble can be prevented from flowing to the distal end by moving the resin-coated wire forward and causing the bubble to relatively transfer from a position of the distal end coating to a position of the proximal end coating and attach to the proximal end coating. Accordingly, the resin-coated wire enables reduction of a risk of administering a bubble together with a drug solution into an affected area, in pushing out the drug solution from a distal end of a catheter using the resin-coated wire.
(2) The resin-coated wire may have a configuration where the wire is a rope wire forming by spirally winding a plurality of fine wires. The resin-coated wire can increase flexibility of the resin-coated wire, easily move the resin-coated wire forward inside a drug solution-containing lumen of a catheter even at a bend of the catheter, and improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(3) The resin-coated wire may have a configuration where each of the plurality of fine wires is stranded wire formed by spirally winding a plurality of strands. The resin-coated wire can effectively increase flexibility of the resin-coated wire, easily move the resin-coated wire forward inside a drug solution-containing lumen of a catheter even at a bend of the catheter, and effectively improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(4) The resin-coated wire may have a configuration where the first resin material permeates a distal end part of the second part of the wire. The resin-coated wire can effectively reduce loss of a drug solution due to e.g., infiltration of a drug solution from a boundary between the proximal end coating and the distal end coating to an inside of the wire. The resin-coated wire can also avoid a sharp change of rigidity of the wire (in turn, rigidity of the resin-coated wire) from the distal end to the proximal end of the wire, and improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(5) The resin-coated wire may have a configuration where a most distal end portion in the resin-coated wire has an approximate hemisphere shape forming a projection toward a distal end. The resin-coated wire can easily move the resin-coated wire forward inside a drug solution-containing lumen of a catheter even at a bend of the catheter, and effectively improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(6) The resin-coated wire may have a configuration where the resin-coated wire includes a most distal end portion, an intermediate portion adjacent to a proximal end side of the most distal end portion and having a taper shape with an outer diameter reduced toward a distal end, and a proximal end portion adjacent to a proximal end side of the intermediate portion and having an approximately constant outer diameter. Owing to having the tapered intermediate portion, the resin-coated wire can easily move the resin-coated wire forward inside a drug solution-containing lumen of a catheter even at a bend of the catheter, and effectively improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(7) The resin-coated wire may have a configuration where a part formed of the first part of the wire has higher rigidity than that of a part formed of the second part of the wire. The resin-coated wire can reduce a risk of deformation or backward movement of a vicinity of the distal end of the resin-coated wire due to a pressure from a drug solution, in moving the resin-coated wire forward inside a drug solution-containing lumen of a catheter, and effectively improve maneuverability of the resin-coated wire and accuracy of drug solution injection by the resin-coated wire.
(8) The drug solution injection device disclosed herein includes the resin-coated wire described above and a catheter. The drug solution injection device thus can improve maneuverability, accuracy of drug solution injection, etc. of a drug solution injection device.
The art disclosed herein can be implemented in various modes, such as resin-coated wire, a drug solution injection device including resin-coated wire, a system including a drug solution injection device, and a method of producing such a device or system.
The drug solution injection device 100 is a medical device used for injecting a drug solution into the body of a patient by employing a catheter capable of being inserted into a living body lumen. A living body lumen herein encompasses a variety of lumens such as a blood vessel, a lymphatic vessel, a biliary tract, a urinary tract, a respiratory tract, a gastrointestinal tract, a secretory gland, a genital tract, and the like. The drug solution injection device 100 includes a needle catheter 10, a resin-coated wire 20, and a controller 30.
The needle catheter 10 is a member used for being inserted into a living body lumen of a patient via e.g., a channel of an endoscope, delivering a drug solution to a desired site in the body of the patient, and injecting the drug solution into the site. The needle catheter 10 includes a catheter shaft 12 and a needle portion 14. The catheter shaft 12 is a long member extending along a center axis AX. In more detail, the catheter shaft 12 is an approximately cylindrical member that includes an opening formed at each of a distal end and a proximal end, and an inner cavity 16 formed inside and in fluid communication with the two openings.
The catheter shaft 12 may have an antithrombotic property, flexibility, and biocompatibility, and can be formed of e.g., a resin material or a metal material. Examples of a resin material available for forming the catheter shaft 12 include polyamide resins, polyolefin resins, polyester resins, polyurethane resins, silicone resins, fluororesins, and the like. Examples of a metal material available for forming the catheter shaft 12 include stainless steel such as SUS304, Ni—Ti alloy, cobalt-chromium alloy, and the like. In addition, a coil body, a braided body or the like may be embedded in a thick part of the catheter shaft 12 for improving at least a part of flexibility, torquability, push-in ability, kink resistance, blood vessel conformability, migration in a lesion, and maneuverability. The catheter shaft 12 may also formed of a plurality of layers formed of the same or different materials. The needle portion 14 may have an antithrombotic property and biocompatibility, and can be formed of e.g., stainless steel such as SUS304, Ni—Ti alloy, or a metal material such as cobalt-chromium alloy. The resin-coated wire 20 is a member for being inserted from a proximal end of the needle catheter 10 into the drug solution-containing lumen L, pushing out the drug solution DS contained in the drug solution-containing lumen L toward a distal end by moving forward inside the drug solution-containing lumen L, and thereby discharging the drug solution DS from a distal end of the needle portion 14. The resin-coated wire 20 is a long member extending along the center axis AX.
The controller 30 is a device including, e.g., a gear mechanism, a roller, and a discharge operation part and capable of moving forward, for a predetermined distance, the resin-coated wire 20 inserted into the drug solution-containing lumen L of the needle catheter 10. When the controller 30 delivers the resin-coated wire 20 for a predetermined distance toward the distal end, the drug solution DS contained in the drug solution-containing lumen L of the needle catheter 10 is pushed toward the distal end by the resin-coated wire 20, and an amount of the drug solution DS equivalent to the volume of the resin-coated wire 20 thus forwarded is discharged from the distal end of the needle portion 14. Such an operation is repeated predetermined times, thereby allowing injection of a predetermined amount of the drug solution DS into the body of a patient.
Next description will be made for a detailed configuration of the resin-coated wire 20.
As depicted in
The wire 24 is a long member extending along the center axis AX. As depicted in
As depicted in
In the following description, the resin-coated wire 20 is virtually separated into several parts along the center axis AX, and a part including the welded portion 23 of the wire 24 is referred to as a most distal end portion P1, a part including the tapered portion 22 of the wire 24 is referred to as an intermediate portion P2, and a part including the straight portion 21 of the wire 24 is referred to as a proximal end portion P3. The most distal end portion P1 and the intermediate portion P2 are collectively referred to as a distal end portion P4.
The coated portion 27 is a film made of a resin and coating the wire 24. Presence of the coated portion 27 provides the resin-coated wire 20 with high slidability, as well as reduces loss of the drug solution DS due to permeation of the drug solution DS into the wire 24 (a space(s) between the fine wires 240 and/or between the strands 242).
The coated portion 27 has a thickness of e.g., about 0.1 mm to 0.2 mm. The resin-coated wire 20 thus has an outer shape approximately identical to the outer shape of the wire 24. In other words, the outer shape of the most distal end portion P1 of the resin-coated wire 20 is an approximate hemisphere shape projecting toward the distal end, as with the outer shape of the welded portion 23 of the wire 24. Additionally, the outer shape of the intermediate portion P2 adjacent to a proximal end side of the most distal end portion P1 is a taper shape with an outer diameter reduced toward the distal end, as with the outer shape of the tapered portion 22 of the wire 24. Furthermore, the outer shape of the proximal end portion P3 adjacent to a proximal end side of the intermediate portion P2 is a straight shape with an approximately constant outer diameter, as with the outer shape of the straight portion 21 of the wire 24.
The coated portion 27 has a distal end coated portion 25 and a proximal end coated portion 26. The distal end coated portion 25 coats the welded portion 23 and the tapered portion 22 of the wire 24. That is, the distal end coated portion 25 forms the distal end portion P4 of the resin-coated wire 20. The proximal end coated portion 26 coats the straight portion 21 of the wire 24. That is, the proximal end coated portion 26 forms the proximal end portion P3 of the resin-coated wire 20.
The distal end coated portion 25 and the proximal end coated portion 26 are formed of different types of resin materials. More particularly, a resin material for forming the distal end coated portion 25 has a higher affinity for water than a resin material for forming the proximal end coated portion 26. Examples of a combination of two resin materials satisfying such a condition include a combination where a resin material for forming the proximal end coated portion 26 is Ethylene Tetrafluoroethylene (ETFE), Polytetrafluoroethylene (PTFE), or Perfluoroalkoxy alkanes (PFA), and where a resin material for forming the distal end coated portion 25 is acrylic urethane, polyethylene, or polyamide. Note that a drug solution to be employed in the drug solution injection device 100 in the embodiment (hereinafter referred to as “drug solution of interest”) is prepared by dissolving a drug into a physiological saline, and thus contains a large amount of water. Therefore, a resin material for forming the distal end coated portion 25 has a higher affinity for a drug solution of interest than a resin material for forming the proximal end coated portion 26. Compatibility with water in a resin material can be represented by a contact angle, and a smaller contact angle indicates higher compatibility with water. A resin material for forming the distal end coated portion 25 is an exemplary first resin material, and a resin material for forming the proximal end coated portion 26 is an exemplary second resin material. For example, the first resin material may be hydrophilic and the second resin material may be hydrophobic.
Moreover, in the embodiment, as depicted in
In the resin-coated wire 20 in the embodiment, the distal end portion P4 includes the welded portion 23 to which each of the fine wires 240 and/or each of the strand 242 included in the wire 24 are jointed. Additionally, in the distal end portion P4, a resin material forming the distal end coated portion 25 permeates between the fine wires 240 and/or between the strands 242 which form the wire 24, thereby adhering the fine wire 240 to one another and the strands 242 to one another. The distal end portion P4 (a part including the welded portion 23 and the tapered portion 22 of the wire 24) of the resin-coated wire 20 thus has higher rigidity than that of the proximal end portion P3 (a part including the straight portion 21 of the wire 24).
An exemplary production method of the resin-coated wire 20 included in the drug solution injection device 100 in the embodiment is as described below. At first, a rope wire fully coated by the proximal end coated portion 26 (a material for forming the wire 24) is prepared. In the rope wire, a part to be finally the tapered portion 22 of the wire 24 is preliminarily processed into a taper shape.
Next, in the rope wire, a piece of the proximal end coated portion 26 on a part to be finally the tapered portion 22 and the welded portion 23 of the wire 24 is peeled off. This causes the proximal end coated portion 26 to coat only a part to be the straight portion 21 of the wire 24 and to expose a part to be the tapered portion 22 and the welded portion 23 of the wire 24.
Subsequently, the most distal end portion of the rope wire is subject to welding from an axis direction by, e.g., YAG laser welding, thereby forming the welded portion 23. This causes formation of the wire 24, which has the straight portion 21, the tapered portion 22, and the welded portion 23.
Then, a material for forming the distal end coated portion 25 (adhesive) is applied to the part where the proximal end coated portion 26 is peeled off in the rope wire. This causes formation of the distal end coated portion 25 coating the tapered portion 22 and the welded portion 23 of the wire 24. Additionally, in the straight portion 21 of the wire 24, a material for forming the distal end coated portion 25 permeates the distal straight portion 28, and adheres the fine wires 240 to one another and/or the strand 242 to one another, all of which are included in the wire 24. This process allows production of the resin-coated wire 20 in the embodiment.
As has been described so far, the drug solution injection device 100 in the embodiment includes the resin-coated wire 20, which is capable of moving forward inside the drug solution-containing lumen L of the needle catheter 10 containing the drug solution DS, and thereby pushing out the drug solution DS from the distal end of the needle catheter 10. The resin-coated wire 20 includes the wire 24, and the coated portion 27 made of resin coating the wire. The coated portion 27 has the distal end coated portion 25 and the proximal end coated portion 26. The distal end coated portion 25 coats the distal end portion of the wire 24 (the welded portion 23 and the tapered portion 22). The proximal end coated portion 26 coats a part (the straight portion 21) adjacent to a proximal end side of the distal end portion (the welded portion 23 and the tapered portion 22) in the wire 24. A resin material for forming the distal end coated portion 25 has a higher affinity for water than a resin material for forming the proximal end coated portion 26.
Accordingly, in the resin-coated wire 20 in the embodiment, a resin material for forming the distal end coated portion 25 has a higher affinity for water than a resin material for forming the proximal end coated portion 26. In other words, a bubble in water (in the drug solution DS) is easily attached onto a surface of the proximal end coated portion 26, while the bubble poorly extends and insufficiently attaches onto a surface of the distal end coated portion 25. Hence, even when a bubble is mixed in the drug solution DS contained in the drug solution-containing lumen L of the needle catheter 10, the bubble can be prevented from flowing to the distal end by moving the resin-coated wire 20 forward and causing the bubble to relatively transfer from a position of the distal end coated portion 25 to a position of the proximal end coated portion 26 and attach to the proximal end coated portion 26. Accordingly, the resin-coated wire 20 in the embodiment enables reduction of a risk of administering a bubble together with the drug solution DS into an affected area, in pushing out the drug solution DS from a distal end of the needle catheter 10 using the resin-coated wire 20.
In the resin-coated wire 20 in the embodiment, the wire 24 is a rope wire formed by spirally winding a plurality of the fine wires 240. The resin-coated wire 20 in the embodiment thus can increase flexibility of the resin-coated wire 20, easily move the resin-coated wire 20 forward inside the drug solution-containing lumen L of the needle catheter 10 even at a bend of the needle catheter 10, and improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
In the resin-coated wire 20 in the embodiment, each of the plurality of the fine wires 240 forming the wire 24 is a stranded wire formed by spirally winding a plurality of the strands 242. The resin-coated wire 20 in the embodiment can thus effectively increase flexibility of the resin-coated wire 20, easily move the resin-coated wire 20 forward inside the drug solution-containing lumen L of the needle catheter 10 even at a bend of the needle catheter 10, and effectively improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
In the resin-coated wire 20 in the embodiment, a resin material for forming the distal end coated portion 25 permeates the distal straight portion 28, which is a distal end part of the straight portion 21 of the wire 24. The resin-coated wire 20 in the embodiment can thus effectively reduce loss of the drug solution DS due to e.g., infiltration of the drug solution DS from a boundary between the proximal end coated portion 26 and the distal end coated portion 25 to an inside of the wire 24. The resin-coated wire 20 can also avoid a sharp change of rigidity of the wire 24 (in turn, rigidity of the resin-coated wire 20) from the distal end to the proximal end of the wire 24, and improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
In the resin-coated wire 20 in the embodiment, the most distal end portion P1 in the resin-coated wire 20 has an approximate hemisphere shape forming a projection toward the distal end. The resin-coated wire 20 in the embodiment can thus easily move the resin-coated wire 20 forward inside the drug solution-containing lumen L of the needle catheter 10 even at a bend of the needle catheter 10, and effectively improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
The resin-coated wire 20 in the embodiment includes the most distal end portion P1, the intermediate portion P2 adjacent to a proximal end side of the most distal end portion P1 and having a taper shape with an outer diameter reduced toward the distal end, and the proximal end portion P3 adjacent to a proximal end side of the intermediate portion P2 and having an approximately constant outer diameter. Owing to having the tapered intermediate portion P2, the resin-coated wire 20 in the embodiment can thus easily move the resin-coated wire 20 forward inside the drug solution-containing lumen L of the needle catheter 10 even at a bend of the needle catheter 10, and effectively improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
In the resin-coated wire 20 in the embodiment, a distal end portion P4 (a part formed of the welded portion 23 and the tapered portion 22 of the wire 24) has higher rigidity than that of the proximal end portion P3 (a part formed of the straight portion 21 of the wire 24). The resin-coated wire 20 in the embodiment can reduce a risk of deformation or backward movement of a vicinity of the distal end of the resin-coated wire 20 due to a pressure from the drug solution DS, in moving the resin-coated wire 20 forward inside the drug solution-containing lumen L of the needle catheter 10, and effectively improve maneuverability of the resin-coated wire 20, accuracy of drug solution injection by the resin-coated wire 20, etc.
The drug solution injection device 100 in the embodiment includes the resin-coated wire 20 and the needle catheter 10 in the aforementioned configuration. The drug solution injection device 100 in the embodiment thus can improve maneuverability, accuracy of drug solution injection, etc. of the drug solution injection device 100.
The art disclosed herein is not limited to the aforementioned embodiment, and can be modified into various forms within a range not departing from the spirit. For example, the following modification is also available.
The configuration of the drug solution injection device 100 in the aforementioned embodiment is solely an example, and can be variously modified. For example, in the aforementioned embodiment, the wire 24 includes the welded portion 23, the tapered portion 22, and the straight portion 21, but the straight portion 21 has another portion close to the proximal end. The wire 24 may not have the welded portion 23 and/or the tapered portion 22.
In the aforementioned embodiment, each of a plurality of the fine wires 240 forming the wire 24 is a stranded wire formed by spirally winding a plurality of the strands 242, but each of the plurality of the fine wires 240 forming the wire 24 may be formed of a single strand. Additionally, in the aforementioned embodiment, the wire 24 is a rope wire formed by spirally winding a plurality of the fine wires 240, but the wire 24 may be formed of a single strand.
In the aforementioned embodiment, the distal end coated portion 25 in the coated portion 27 coats the welded portion 23 and the tapered portion 22 of the wire 24, and the proximal end coated portion 26 coats the straight portion 21 of the wire 24, but the configuration of the coated portion 27 is not limited thereto. For example, the distal end coated portion 25 may coat the welded portion 23 and a part close to the distal end in the tapered portion 22, and the proximal end coated portion 26 may coat a part close to the proximal end in the tapered portion 22 and the straight portion 21. Alternatively, the distal end coated portion 25 may coat the welded portion 23, the tapered portion 22, and a part close to the distal end in the straight portion 21, and the proximal end coated portion 26 may coat a part close to the proximal end in the straight portion 21.
A material for forming each member included in the drug solution injection device 100 in the embodiment is solely an example, and can be variously modified. A method of producing the resin-coated wire 20, which is included in the drug solution injection device 100 in the embodiment, is also solely an example, and can be variously modified.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2021-099904 | Jun 2021 | JP | national |
This application is a continuation application of International Application No. PCT/JP2022/018177, filed Apr. 19, 2022, which claims priority to Japanese Patent Application No. 2021-099904, filed Jun. 16, 2021. The contents of these applications are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2022/018177 | Apr 2022 | US |
| Child | 18539290 | US |
