Package for needle catheters
Patent Information
- Application Number
- PCT/US2024/040603
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-30
- Filing Date
- 2024-08-01
- Publication Date
- 2025-05-08
AI Technical Summary
The existing methods for protecting needle catheters are laborious, prone to damage or contamination, and increase manufacturing costs, while also affecting light-emitting stability and environmental impact due to the need for disposable protectors and manual puncture depth markings.
A package with a folding flat needle tray and holder structure that protects the distal ends of needle catheters without contamination, improves handleability, and includes an indicator for puncture depth without affecting light-emitting stability, all while reducing environmental impact and manufacturing costs.
The solution enables safe, efficient protection of needle catheters, enhances operability, maintains light-emitting stability, and reduces environmental and manufacturing costs by eliminating the need for disposable protectors and manual markings.
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Figure US2024040603_08052025_PF_FP_ABST
Abstract
Description
L DESCRI PTIONl [ Title j PACKAGE FOR NEEDLE CATHETERS [Cross-Reference to Related Applications]
[0001] This application is based upon and claims the benefit of priority from prior Japanese Patent Application No . 2023-107890, filed June 30, 2023, the entire contents of which are incorporated herein by reference . [Technical Field]
[0002] The present invention relates to a package for medical needle catheters .[Background Art ]
[0003] Needle catheter generally comprises , for example, a needle formed of resin and an obturator formed of stainless steel . Such needle catheter is used to introduce a diff user for intersti tial radiation composed of optical fiber into tissue .
[0004] When it is used, the distal end portion of the needle catheter is made to puncture the tissue in a state in which the obturator is inserted in the lumen of the needle . After that, the obturator is extracted and only the needle is left in the tissue . Then, the di ffuser for intersti tial radiation i s Inserted into the lumen of the needle lef t in the tissue . In thi s state, a laser beam emitted from the diffuser is radiated into the tissue through the needle, and light treatment in the tissue is thereby performed.Citation ListPatent LiteratureL 0005I[FTL 1]JF 2009-18182 A[Summary of Invention][Technical Problem]
[0006] Generally, a needle catheter has its distal end portion protected by a dedicated protector . For example , if needle catheters are prepared, a protector ( for example, a protective cap) is attached to each of the distal end portions of the needle catheters .
[0007] However, the process of attaching a protector to each of the needle catheters involves a high risk of the needle catheters (especiall y, the distal end portions ) being damaged, broken, or contaminated. Thus , the process requires close attent ion and extremely laborious work, and as a result, it is troublesome and time-consuming .
[0008] Moreover, when a needle catheter with a protector attached thereto is used, the protector must be detached, so that the operability or handleability of the needle catheter deteriorates . Furthermore, since the protector detached from the needle catheter cannot be reused and thus is disposed of , the impact on the environment may be significant depending on the number of used protectors to be di sposed of .
[0009] In addition, since a protector needs to be prepared for each individual needle catheter, the cost of manufacturing protectors increases, and as a result, the entire manufacturing cost of needle catheters alsoincreases .
[0010] Moreover, a protector attached to a needle catheter has no indicator of a puncture length or puncture depth to which the needle catheter is made to puncture tissue . Thus, at a clinical site, the outside of the needle catheter is marked with the puncture length or puncture depth measured in advance by a ruler or the like , so that a spot appears in light transmitted through the catheter because of the marking and may affect light- emitting stability .
[0011] In view of the above, an obj ect of the present invention is to provide a package for needle catheters which can safel y protect needle catheters (especially, distal end port ions ) without contamination easily and in a short time, which has good operability or handleabiii ty of the needle catheters , and which does not affect light-emitting stabili ty, at low cost with low impact on the environment . [Solution to Problem j
[0012] In order to achieve the above obj ect, the present invent ion comprises a holder structure which is configured to hold medical needle catheters in a state in which the needle catheters are arranged at intervals in a preset direction and a folding flat needle tray provided wi th the holder structure, dis tal end portions of the needle catheters being simultaneously protected together by folding part of the needle tray to cover the distal end portions of the needle catheters held by the holder structure .[Advantageous Effects of Invention]The present, invention can achieve a package for needle catheters which can safely protect needle catheters (especially, distal end portions) without contaminaticn easily and in a short time, which has good operability or handleability of the needle catheters, and which does not affect light-emitting stabil ity at low cost with low impact on the environment .[Brief Description of Drawings ]
[0014] [FIG. 1 ]FIG . 1 is a perspective view of a package for needle catheters according to an embodiment of the present invention .[FIG . 2 ]FIG . 2 is a perspective view il lustrating constituent parts of a needle catheter .[FIG . 3 ]FIG . 3 is an unfolded view of a folding needle tray . [Mode for Carrying Out the Invention]
[0015] (Contents of Embodiment )FIG . 1 is an overall structural view of a package 1 for needle catheters . The package 1 for needle catheters comprises a folding flat needle tray 2 , a holder structure 3 provided on the needle tray 2 , and a hermetic pack 4 .[0(116]Needle catheters 5 are general ones used at a clinical site, and each comprise an operation portion 5a and a long catheter main body 5b eKtendiug slenderly from the operation portion 5a . The catheter main body 5b has a proximal end port ion 5e supported by the operationportion 5a and a distal end portion St on the opposite side to the proximal end port ion 5e, which is a free end that can puncture tissue .
[0017] The hermetic pack 4 may be, for example, a commercial existing one, and an obj ect can be contained therein in an airtight state by clos ing one end side 4a after the obj ect is contained from the one end side 4a . In addition, when the obj ect contained in the hermetic pack 4 is extracted, the obj ect can be easi ly extracted without resistance from the hermetic pack 4 by opening it from an apex portion 6t of an inverted V-shaped seal 6 which closes in advance the other end side 4b (opposite to the one end side 4a) .
[0018] In FIG . 1 , the needle catheters 5 held by the holder structure 3 are assumed as an example of the object . In this case, the needle catheters 5 , together with the needle tray 2 , are contained and hermetically enclosed in the hermet ic pack 4 , in a state in which the dis tal end portions 5t of the needle catheters 5 held by the holder structure 3 are simultaneously protected together by folding part of the needle tray 2 . rooi 9]As illustrated in FIG . 1 , part of the needle tray 2 can be folded . Therefore, the needle tray 2 comprises a tray main body port ion 2a on which the holder structure 3 Is disposed, a folding port ion 2b which can fold to face the tray main body portion 2a, and a coupling portion 2c which couples the tray main body portion 2a and the folding portion 2b to each other .
[0020] Here , part of the needle tray 2 is folded to cover thedistal end portions St of the needle catheters 5 held by the holder structure 3 . That is , the folding portion 2b is folded around the coupling portion 2c to face the tray main body portion 2a . The distal end portions St of all of the needle catheters 5 are thereby simultaneously protected together between facing parts of the folded needle tray 2 . That is, the distal end portions St of the needle catheters 5 held by the holder structure 3 are protected in a state of being contained in an area surrounded by the tray main body portion 2a, the folding portion 2b, and the coupling portion 2c .
[0021] Moreover, the needle tray 2 comprises an engagement portion 2d extending from the folding portion 2b on the opposite side to the coupling portion 2c . When the folding portion 2b is folded, around the coupl ing portion 2c to face the tray main body portion 2a , the engagement portion 2d is engaged to catch parts of the needle catheters 5 held by the holder structure 3, and thereby keeps the folding portion 2b facing the tray main body portion 2a .[ Q022 ]The engagement portion 2d is provided with engagement grooves g disposed at intervals . The engagement grooves g are formed to catch parts of the needle catheters 5 (in FIG . 1 , the catheter main bodies 5b as an example) , respectively . In this case, when the folding portion 2b is folded to face the tray main body portion 2a, the engagement portion 2d is engaged to cause the catheter main bodies 5b to be caught in the engagement grooves g, respectivel y . As a result, the folding portion 2b is kept facing the tray main bodyportion 2a . rnz a]The holder structure 3 provided on the needle tray 2 as described above can hold the needle catheters 5 in a state in which the needle catheters 5 are arranged at intervals in a preset direction in the tray main body portion 2a . In FIG . 1, as an example, the needle catheters 5 are arranged parallel to each other and at regular intervals in a direction Di transver sely crossing the tray main body portion 2a (hereinafter, referred to as a tray main body portion transversely crossing direction DI ) . In such configuration, the respective operation portions 5a are disposed at positions adj acently arranged and parallel to each other, and the respective catheter main bodies 5b are disposed at positions adj acently arranged and parallel to each other .
[0024] FIG . 2 is a structural view of a needle catheter 5. The needle catheter 5 comprises , for example, a needle 7 formed of resin and an obturator 8 formed of stainless steel, and is used to introduce a diffuser for interstitial radiation (not illustrated) formed of optical fiber into tissue .
[0025] As illustrated in FIG . 2, when the needle catheter 5 is used, the obturator 8 is inserted into the needle 7 . At this time, a distal end 8t of the obturator 8 and a distal end 7t of the needle 7 contact each other . The rigidity of the obturator 8 is thereby imparted to the needle 7 . As a result, the shape of the catheter main body 5b i s kept in a slender shape extending straight .In this way, the catheter main body 5b of the needlecatheter 5 can stably puncture tissue from its distal end portion 5t .[002&]Following placement in the tissue, the obturator 8 is removed by a locking collar 9 and only the needle 7 is left in the tissue . Then, the diffuser for interstitial radiation is inserted into the needle 7 left in the tissue . In this state, light, such as from a laser beam, is emitted from the diffusor and is radiated into the tissue through the needle 7 , and light treatment in the tissue is thereby performed.
[0027] It is necessary to accurately ascertain in advance the puncture length or puncture depth to which the catheter main body 5b punctures the tissue . Thus, the outside of the needle catheter 5 may be conventionally marked with the puncture length or puncture depth measured in advance, so that a spot appears in light transmitted through the catheter main body 5b because of the marking and may af fect light-emitting s tability .
[0028] In embodiments herein, the package 1 for needle catheters of the present embodiment can be provided with an indicator 10 (see FIG . 3) far ascertaining the puncture length or puncture depth to which the catheter main body 5b punctures tissue, at a position avoiding the needle catheters 5 ,
[0029] FXG . 3 is a disposition structural view of the indicator 10 added to the needle tray 2 . FIG . 3 i llustrates the needle tray 2 unfolded flat . The needle tray 2 is composed of the tray main body portion 2a, the coupl ing port ion 2c, the folding portion 2b,and the engagement portion 2d, which are continuously arranged in order from the right in FIG . 3.Ft) 030]As illustrated in FIG . 3, the tray main body portion 2a is provided with the holder structure 3 for arranging the needle catheters 5 {see FIG . 1 ) parallel to each other and at regular intervals in the above-described tray main body portion transversely crossing direction DI . The holder structure 3 comprises holder s 11 , 12 , 13, 14 , and 15.
[0031] As illustrated in FIG . 3, the holders 11 , 12, 13, 14 , and 15 are formed by cutting out parts of the tray main body portion 2a and leaving the other parts of the tray main body portion 2a . Parts P cut out from the tray main body portion 2a (hereinafter, referred to as cutcut parts P) extend parallel and in a rectangular shape in the tray main body portion transversely crossing direction DI , while parts L lef t on the tray main body portion 2a (hereinaf ter, referred to as left parts L) extend parallel and linearly in the tray main body portion transversely crossing direction DI .[ Q032 ]With this structure, the rectangular holders 11, 12 ,13 , 14 , and 15 can be provided to stand on the tray main body portion 2a by folding back the rectangular cutout parts P to rai se them from the tray main body portion 2a with the l inear remained parts I. acting as fulcra . In such configuration, the holders 11 , 12, 13,14 , and 15 each extend in the tray main body portion transversely crossing direction DI , and are disposed parallel to each other in a direction D2 longitudinally crossing the tray main body portion (hereinafter,lu referred to as a tray main body portion longitudinally crossing direction D2 ) that, is orthogonal to the tray main body portion transversely crossing direction DI .
[0033] The rectangular holders 1'1, 12 , 13, 14 , and 15 may each comprise support portions S . The support portions S are disposed at regular intervals in the tray main body portion transversely crossing direction DI in each of the holders 11 , 12 , 13 , 14 , and 15, and are disposed at posi tions arranged straight in the tray main body portion longitudinally crossing direction D2 between the holders 11 , 12 , 13, 14 , and 15.
[0034] Here, as illustrated in FIG . 1 and FIG . 3, each of the needle catheters 5 is placed along the support portions S arranged straight In the tray main body portion longitudinally cressing direction D2 . The needle catheters 5 thereby can be aligned with the tray main body portion longitudinally crossing direction D2 , and at the same t ime, can be disposed parallel to each other and at regular intervals in the tray main body portion transversely crossing direction DI .
[0035] In FIG . 1 and FIG . 3, as an example, the holders 11 , 12 , 13, 14 , and 15 are disposed at intervals in the tray main body portion longitudinally crossing direction D2 . That i s, a pai r of holders that supports the dis tal end portions 5t and the proximal end portions 5e of the catheter main bodies 5b of the needle catheters 5 ( the first holder 11 and the second holder 12 ) , two holders provided between the pair of holders 11 and 12 (the third holder 13 and the fourth holder 14 ) , the fif th holder 15 provided outside thefirst holder 11 (that is, on the apposite side to the second to fourth holders 12 to 14 ) are provided .[QQ3G]The support portions S of the first to fourth holders 11 to 14 are set to a site which can hold and support the long catheter main bodies 5b extending slenderly. The catheter main bodies 5b placed on the first to fourth holders 11 to 14 are thereby supported to be caught by the support portions 5, respectively .
[0037] The support portions S of the fifth holder 15 are set to a size which can hold and support the operation portions 5a of the needle catheters 5 relatively large in diameter . The catheter main bodies 5b placed on the fifth holder 15 are thereby supported to be caught by the support portions S, respectively .
[0038] The operation portions 5a of the needle catheters 5 are held between the firs t holder 11 and the fif th holder 15. That is, the first holder 11 is brought into contact with end faces of the operation portions 5a which support the proximal end portions 5e of the catheter main bodies 5b (end faces 5s on the catheter main body 5b side ( see FIG . 2 ) ) .[ 01)39]In this way, as illustrated in FIG. 1 and FIG . 3, the needle catheters 5 are held by the above-described first to fi fth holders 11 to 15 in a state of being arranged at regular intervals in a preset direction (that is, the tray main body portion transversely crossing direction DI ) in the tray main body portion 2a without being displaced in the tray main body portion longitudinally crossing direction D2 or dropping fromthe tray main body portion 2a .[OCM O]In the needle tray 2 as described herein, the indicator 10 is added to the tray main body portion 2a . The indicator 10 is configured to allow the puncture length or puncture depth of the needle catheters 5 held by the holder structure 3 (that is , the puncture length or puncture depth to which the catheter main bodies 5b punctures tissue) to be visually ascertained .
[0041] The indicator 10 is composed of graduations marked at regular intervals on the needle tray 2 , and allows the puncture length or puncture depth of the needle catheters 5 (catheter main bodies 5b) to be visually ascertained on the basi s of the graduations . In FIG . 3 , as an example, the indicator 10 composed of the same graduations as those of a ruler is added to ( for example, printed on) the tray main body portion 2a in the tray main body portion longitudinally crossing direction D2 .(0042 )The indicator 10 composed of the same graduations as those of a ruler is provided from the linear remained part L of the first holder 11 beyond the linear remained part L cf the second holder 12 on the tray main body portion 2a . In FIG . 3, as an example, the indicator 10 with graduations to 10 cm marked at intervals of 1 cm from the linear remained part L of the first holder 11 , which is set to 0 cm (centimeters) , is provided.
[0043] In this case, the graduations of 0 cm to 10 cm ( indicator 10 ) are provided at positions avoiding theneedle catheters 5 supported by the holder structure 3 in the tray main body portion 2a , In FIG . 3, as an example , the graduations of 0 cm to 10 cm (indicator 10) are provided parallel to each other along both sides of the above-described first to fifth holders 11 to IS, and numerical values of 1 to 10 are added to both of them at regular intervals .
[0044] (Features and Advantages of the Embodiments ) In the present embodiments, the distal end portions 5t of the needle catheters 5 can be simultaneously protected together easily and in a short time simply by folding part of the needle tray 2 (that is, the folding portion 2b) - This removes the necessity for a conventional laborious process such as preparing a large number of protectors and attaching and detaching the protectors . As a result, it is possible to eliminate the risk of the needle catheters 5 (especially, the distal end portions 5t) being damaged or broken or being contaminated. Furthermore, it is possible to improve the operability or handleability of the needle catheters 5, and reduce the impact on the environment while achieving a reduction in cost . (0045] In embodiments herein, the needle tray 2 comprises the engagement portion 2d extending from the folding portion 2b on the oppos ite side to the coupling portion 2c. In thi s case, the engagement portion 2d is engaged to catch parts of the needle catheters 5 (that is , the catheter main bodies 5b) held by the holder structure 3 , when the folding portion 2b is folded around the coupling portion 2c to face the tray main body portion 2a . The folding port ion 2b thereby can be kept facingthe tray main body portion 2a, and as a result, the dis tal end portions 5t of the needle catheters S held by the holder structure 3 can be protected in a s tate of being contained in an area surrounded by the tray main body portion 2a, the folding portion 2b, the coupling portion 2c, and the engagement portion 2d,
[0046] In embodiments herein , the indicator 10 , which allows the puncture length or puncture depth of the needle catheters 5 held by the holder structure 3 (that is , the puncture length or puncture depth to which the catheter main bodies 5b puncture tissue) to be visually ascertained, is added to the needle tray 2 . This removes the necessity for a process performed at a conventional cl inical site such as marking the outside of the needle catheters 5 with the puncture length or puncture depth measured in advance with a ruler or the l ike . As a result, the light-emitting stability of light transmi tted through the catheter main bodies 5b is not affected, and stable l ight treatment can be performed .
[0047] (Additional embodiments and modifications to embodiments described herein) Modification of embodiments herein include modifications where the indicator 10 may be marked with the graduat ions of 0 cm to 10 cm at intervals of 1 cm . For example, the indicator 10 marked with the graduations of 0 am to 10 cm at intervals of 5 mm instead is also included in the technical scope of the present invention . In this case, the graduations may be graduations to 10 cm or greater, or may be graduations to 10 cm or less .Embodiments herein include ones with graduations (indicator 10) provided parallel to each other along both sides of the first to fifth holders 11 to IS on the tray main body portion 2a . For example, the indicator 10 with graduations continuing from both sides of the first to fifth holders 11 to 15 in the tray main body portion transversely crossing direction DI instead is also included in the technical scope of the present invention .
[0049] Additional advantages and modifications will readily occur to these skil led in the art . Therefore, the invention in its broader aspects is not limited to the specific detail s and representative embodiments shown and described herein . Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents .
Claims
[CLAIMS 1[Claim 11A package for needle catheters, comprising : a holder structure which is allowed to hold medical needle catheters in a state in which the needle catheters are arranged at intervals in a preset direction; and a folding flat needle tray provided with the holder structure, distal end portions of the needle catheters being simultaneously protected together by folding part of the needle tray to cover the distal end portions of the needle catheters held by the holder structure .’flie pacrage .r.or needre catiieters or claim, i , wriere in the needle tray comprises : a tray main body portion on which the holder structure is disposed; a folding portion which is foldable to face the tray main body portion; and a coupling portion which couples the tray main body portion and the folding portion to each other, and the dis tal end portions of the needle catheters held by the holder structure are protected in a s tate of being contained in an area surrounded by the tray main body portion, the folding portion, and the coupling portion, by folding the folding port ion around the coupl ing portion to cause the folding port ion to face the tray main body portion .[Claim 31The package for needle catheters of claim 2 , wherein the needle tray comprises an engagement portion extending from the folding portion on an opposite sideto the coupling portion, and the engagement portion keeps the folding portion facing the tray main body portion by engaging to catch parts of the needle catheters held by the holder structure, when the folding portion is folded around the coupling portion to face the tray main body portion .[Claim 4 1The package for needle catheters of claim 1 , wherein an indicator is added to the needle tray, the indicator allowing a puncture length of the needle catheters held by the holder structure to be visually ascertained. [Claim 51The package for needle catheters of claim 4 , wherein the indicator is composed of graduations marked at regular intervals on the needle tray, and allows the puncture length of the needle catheters to be visually ascertained, based on the graduations .A package for needle catheters, comprising ; the holder structure and the needle tray of any one of claims 1 to 5 ; and a hermetical pack in which the needle catheters, together wi th the needle tray, are allowed to be contained and hermetically enclosed in a state in which the distal end portions of the needle catheters held by the holder structure are simultaneously protected together by folding part of the needle tray .
Citation Information
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