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EP-4734864-A2 - NEEDLE CATHETER

EP4734864A2EP 4734864 A2EP4734864 A2EP 4734864A2EP-4734864-A2

Abstract

The catheter includes a needle 2 that is punctured into tissue and an obturator 3 that is extractably inserted with respect to the needle, the needle has a hollow needle body 2a with a pointed distal end portion 2t and a needle hub 2b that supports a proximal end portion 2e, the interior of the needle body includes a single lumen 2p continuous from the proximal end portion to the distal end portion and a closed end 2c that closes the lumen, and the closed end has a contoured shape that is rounded and continuous in the shape of an arc.

Inventors

  • KAWASHIMA, MASAMI
  • BAYS, ROLAND

Assignees

  • Rakuten Medical, Inc.

Dates

Publication Date
20260506
Application Date
20240627

Claims (14)

  1. [Claim 1] A needle catheter comprising: a needle that is to be punctured into tissue; and an obturator that is extractably inserted with respect to the needle, wherein, the needle includes: a hollow and long needle body that is molded of a translucent resin material and provided with a pointed and closed distal end portion; and a needle hub that supports a proximal end portion of the needle body on an opposite side of the distal end portion, the interior of the needle body is configured to Include : one lumen that continuously extends from the proximal end portion to the distal end portion; and a closed end that closes the lumen at the distal end portion so as to become an end of the lumen, and the closed end has a rounded, arcuate, continuous contour shape,
  2. [Claim 2] The needle catheter of claim 1, wherein the obturator includes a long obturator body which is extractably inserted into the lumen of the hollow needle body, the obturator body is configured with rigidity capable of maintaining a preset contour shape and with a contact end capable of surface contacting the closed end of the needle body, and in a state where the obturator body is inserted into the lumen of the needle body, the contact end of the obturator body and the closed end of the needle body are in surface contact, and the rigidity of the obturator body is imparted to the needle body, so that the needle body is maintained in a shape that follows the contour of the obturator body.
  3. [Claim 3] The needle catheter of claim 1 or claim 2, wherein one or both of the needle and the obturator are provided with a groove structure to allow flow of a sterilizing gas, the groove structure is configured to penetrate a part of the joining area where, when the obturator is inserted into the needle, the obturator is joined to the needle without any gap therebetween, and in a state where the needle catheter is exposed to the sterilizing gas atmosphere, the sterilizing gas flows through the joining area where the groove structure is configured, thereby sterilizing entire front and back surfaces of both the needle and the obturator.
  4. [Claim 4] The needle catheter of claim 3, wherein the groove structure is configured by one or a plurality of grooves arranged on one or both of the needle and the obturator in the joining area, and the groove is configured by partially depressing the joining area.
  5. [Claim 5] The needle catheter of claim 3 or claim 4, wherein in a state where the obturator is inserted into the needle and joined together without any gap, the joining area forms a conical shape tapering toward a direction of insertion, the one groove is arranged along the insertion direction, and the plurality of grooves are each arranged along the insertion direction and configured spaced apart along a circumferential direction.
  6. [Claim 6] The needle catheter of any one of claims 1 to 5, wherein the needle catheter comprises a locking collar that mutually secures the obturator and the needle when the obturator is inserted into the needle, and the locking collar has an identification mark added to a part of or all of its outer surface to enable visual identification of a type of needle.
  7. [Claim 7] The needle catheter of claim 6, wherein the Identification mark includes, at least, coloring, uneven marks, symbols, numbers, and letters, and the type of needle includes at least a total length of the needle body.
  8. [Claim 8] The needle catheter of any one of claims 1 to 7, wherein the proximal end portion of the needle body is configured by including a flair structure protruding outward from the needle body, the needle hub is configured by a resin material molded to cover the flair structure, and the needle body is coupled to the needle hub by the flair structure biting into the resin molded needle hub.
  9. [Claim 9] The needle catheter of claim 8, including one of the following forms as a protruding form of the flair structure : a form protruding outward along a first direction orthogonal to the needle body; a form protruding outward toward a direction between the first direction and a second direction from the distal end portion toward the proximal end portion; and a form protruding outward toward a direction between the first direction and a third direction from the proximal end portion toward the distal end portion.
  10. [Claim 10] The needle catheter of claim 8, including one of the following forms as a protruding form of the flair structure : a form protruding continuously along an outer circumference of the needle body; and a form protruding intermittently along the outer circumference of the needle body.
  11. [Claim 11] A system comprising the needle catheter of any one of claims 1 to 10 and a diffuser configured to emit light.
  12. [Claim 12] Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 for phototherapy or photoimmunotherapy .
  13. [Claim 13] Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 for treatment of a tumor or lesion .
  14. [Claim 14] Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 in combination with a light- activatable therapy or light-activatable drug.

Description

[DESCRIPTION] [Title] NEEDLE CATHETER [Cross-Reference to Related Applications] [0001] This application is based upon and claims the benefit of priority from prior Japanese Patent Application No. 2023-107888, filed June 30, 2023, the entire contents of which are incorporated herein by reference. [Technical Field] [0002] The present invention relates to a needle catheter for medical use. [Background Art] [0003] Currently, this type of needle catheter comprises, for example, a resin needle and a stainless steel obturator, and is used for introducing into tissue a diffuser for interstitial irradiation, which is configured by optical fibers. [0004] When using the catheter, first, the needle is punctured into the tissue while the obturator is kept inserted into the lumen of the needle. After that, the obturator is removed and only the needle is retained in the tissue. The diffuser for interstitial irradiation is then inserted into the lumen of the needle that is retained in the tissue. In this state, a laser beam emitted from the diffuser is irradiated through the needle into the tissue, thereby performing light therapy in the tissue. Citation List Patent Literature [0005] [PTL 1] JP 2005-523117 A [Summary of Invention] [Technical Problem] [0006] Needle catheters are used in the medical field for the purpose of maintaining, restoring, and improving human health, for example. in the environment of diagnosis and treatment of diseases. Therefore, needle catheters are required to maintain a certain level of quality in terms of durability, sterilizability, identifiability, non-degradability, and the like. [0007] As a quality related to durability, the lumen contour of a conventional needle tip has an angular contour shape (e.g., a rectangular inner surface shape) with a steeply varying angle. According to such a contour shape, for example, when an external force acts on the needle during diagnosis or treatment, stress is easily concentrated in the angular portion of the tip lumen. Depending on the strength of the stress, the tip of the needle may rupture or break prematurely. Therefore, a certain level of durability is required to prevent this from happening. [0008] As a quality related to sterilizability, needle catheters are configured by two components (needle and obturator) joined in a luer taper relationship. According to such a joint condition, it is difficult to ensure that the sterilizing gas is distributed evenly over the entire front and back surfaces of each component . In that case, there is a risk that insufficiently sterilized portions may remain in, for example, a joining area where no gaps are formed due to the luer taper relationship, or a needle lumen area where the obturator is inserted. Therefore, a certain level of sterilizability is required to prevent this from happening. [0009] As a quality related to identifiability, needle catheters are prepared in advance in multiple types with different lengths. A needle catheter with an optimum length is selected according to the amount of puncture (depth of puncture) into the tissue in diagnosis and treatment. In this case, it is difficult to accurately identify the needle catheter with the optimum length from among the multiple types in a short period of time. In the case where the catheter is incorrectly selected, the diagnosis or treatment may have to be redone. Therefore, a certain level of identifiability is required to prevent this from happening . [0010] As a quality related to non-degradability, among the needle catheter components (needle and obturator), the needle is configured by two parts (needle hub and long needle body) made of polyacetal (POM), which is an engineering plastic, that are coupled to each other. Polyacetal (POM) is a material (synthetic resin) that is extremely difficult to bond to other things by itself . In this case, depending on the coupled state, the parts may come apart from each other, and, for example, the needle body may fall off the needle hub. Therefore, a certain level of non-degradability is required to prevent this from happening. [0011] The purpose of the present invention is to meet the requirements mentioned above and provide a needle catheter capable of maintaining a certain level of quality in terms of durability, sterilizability, identifiability, non-degradability, and the like. [Solution to Problem] [0012] To achieve such a purpose, the present invention comprises a needle that is to be punctured into tissue and an obturator that is extractably inserted with respect to the needle, in which the needle includes a hollow and long needle body that is molded of a translucent resin material and provided with a pointed and closed distal end portion and a needle hub that supports a proximal end portion of the needle body on an opposite side of the distal end portion, the interior of the needle body is configured to include one lumen that continuously extends from the proximal end portion to the distal end po