WO2024161676A1 - Dispositif d'administration de solution de médicament - Google Patents
Dispositif d'administration de solution de médicament Download PDFInfo
- Publication number
- WO2024161676A1 WO2024161676A1 PCT/JP2023/024881 JP2023024881W WO2024161676A1 WO 2024161676 A1 WO2024161676 A1 WO 2024161676A1 JP 2023024881 W JP2023024881 W JP 2023024881W WO 2024161676 A1 WO2024161676 A1 WO 2024161676A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- needle
- administration device
- adhesive
- solution administration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
Definitions
- the present invention relates to a drug solution administration device.
- Medicine administration devices that administer a desired amount of medicinal liquid to a living body at an appropriate time are known (see, for example, JP2013-500793A).
- the medicine administration device has a needle that is inserted into the living body, and is attached to the body surface of the living body by an adhesive.
- the present invention aims to solve the above-mentioned problems.
- One aspect of the present invention is a drug solution administration device comprising: a catheter having a catheter body to be placed in a living body; an inner needle inserted into the catheter; a needle holding part that holds a base end of the inner needle; a needle member removably attached to the catheter; a holder that holds the base end of the catheter; an adhesive having an attachment surface to be attached to the body surface of a living body and a surface opposite to the attachment surface, a part of the surface being joined to the holder; and a release sheet that is overlaid on the attachment surface so as to cover the adhesive and is peelable from the attachment surface, the release sheet having an extension that extends in a proximal direction beyond the adhesive body, and when the needle holding part and the extension are viewed in a direction from the holder toward the adhesive body, at least a part of the needle holding part overlaps the extension.
- a multi-needle consisting of a catheter and an inner needle
- the holder adheresive
- wrinkles may form on the adhesive when the inner needle is removed, resulting in insufficient application to the body surface.
- the adhesive may peel off from the body surface and the catheter may fall out of the living body.
- the needle holding portion and the extension portion are viewed in the direction from the holder toward the adhesive, at least a part of the needle holding portion overlaps with the extension portion. Therefore, before applying the adhesive to the body surface, the user can easily see the needle holding portion rather than the extension portion of the release sheet. This makes it difficult for the user to apply the adhesive to the body surface before removing the inner needle from the catheter.
- the catheter can be placed stably.
- the patch body includes a first attachment portion having a first attachment surface and a second attachment portion having a second attachment surface, the first attachment portion extends at least above the catheter body, and a portion of the surface of the second attachment portion opposite the second attachment surface is connected to the holder, and the release sheet includes a first sheet covering the first attachment surface and a second sheet covering the second attachment surface, and the second sheet may include the extension portion.
- the tip of the catheter can be maintained inserted inside the body by attaching the first attachment part to the body surface, making it easier to then fix the holder to the body surface with the second attachment part.
- the second sheet may have a covering portion that covers the second application surface and an operating portion that is folded back from the tip of the covering portion toward the base end, and the operating portion may have the extension portion.
- the second sheet is folded back at the tip of the second application surface, so the second sheet can be easily peeled off by pulling the extension toward the base end.
- the second sheet may have a curved slit and be formed in a spiral shape along the slit.
- the second sheet can be easily peeled off from the patch by pulling the extension in the proximal direction.
- the catheter has a catheter hub that holds the base end of the catheter body, and the holder has a base portion formed in a flat plate shape to which the patch is fixed, and a hub holding portion formed in a cylindrical shape, at least a tip of which is connected to the base portion, and into which the tip of the catheter hub is inserted and holds the tip of the catheter hub, and the hub holding portion may hold the catheter hub so that the axis of the catheter hub is inclined relative to the base portion.
- This configuration allows the catheter to be more stably placed in the body because it is inclined relative to the body surface.
- a connecting portion may be formed to releasably connect the needle holding portion and the extension portion.
- the holder cannot be attached to the body surface unless the connection part is released. This makes it easier to avoid attaching the holder to the body surface before removing the inner needle.
- the needle holding portion and the extending portion when the needle holding portion and the extending portion are viewed in the direction from the holder toward the patch, at least a portion of the needle holding portion overlaps with the extending portion. This makes it easier for the user to see the needle holding portion rather than the extending portion of the release sheet before applying the patch to the body surface. This makes it difficult for the user to apply the patch to the body surface before removing the inner needle from the catheter. As a result, by applying the patch to the body surface after removing the inner needle from the catheter, it becomes possible to stably place the catheter.
- FIG. 1 is a plan view of a drug solution administration device according to an embodiment of the present invention.
- FIG. 2 is a cross-sectional view of a needle unit of the drug solution administration device.
- FIG. 3 is a partial side view of the needle unit.
- FIG. 4 is a perspective view of the needle unit as viewed from the release sheet side.
- FIG. 5 is a view of a needle unit according to a modified example, seen from the release sheet side.
- the drug solution administration device 10 is configured to be placed on the body surface, such as the abdomen, of a patient (living body) and to automatically administer a drug solution into the body.
- the drug solution administration device 10 is used, for example, when administering a drug solution to a patient a predetermined time after a medical procedure has been performed on the patient, or when administering a drug solution gradually over time.
- the drug solution administered by the drug solution administration device 10 is, for example, liquid pharmaceuticals such as antibody drugs, anticancer drugs, chemotherapy drugs, anesthetic drugs, antibiotics, insulin, blood products, and nutrients.
- the drug solution administration device 10 comprises a needle unit 12 and a device body 14.
- the needle unit 12 is placed on the body surface and inside the body (subcutaneously) to form a section for introducing the drug solution into the living body.
- the needle unit 12 comprises a catheter 16, a needle member 18 inserted into the catheter 16, a holder 20 that holds the catheter 16, an adhesive 24 connected to the holder 20, and a release sheet 28 superimposed on the adhesive 24.
- the catheter 16 has a catheter body 30 that is placed in the living body, and a catheter hub 32 that holds the base end of the catheter body 30. Note that the patch 24 and the release sheet 28 are not shown in FIG. 2.
- the catheter body 30 is a flexible tubular body made of, for example, a resin material. An internal cavity is formed inside the catheter body 30 to allow the flow of medicinal fluid.
- the catheter hub 32 has a hollow cylindrical hub body 321 and a hollow cylindrical side port 322 that protrudes obliquely from the side of the hub body 321.
- the catheter hub 32 is made of, for example, a resin material and is harder than the catheter body 30.
- the base end of the catheter body 30 is fixed to the tip of the hub body 321.
- a valve body 34 made of an elastic body is arranged on the base end side of the tip opening of the side port 322.
- the side port 322 protrudes obliquely in the base end direction from the middle part between the tip and base ends of the hub body 321.
- the needle member 18 has an inner needle 36 inserted into the catheter 16 and a needle holding portion 38 that holds the base end of the inner needle 36.
- the needle member 18 is removably attached to the catheter 16.
- the tip end including the needle tip 361 of the inner needle 36 protrudes from the tip opening of the catheter body 30, and the catheter body 30 and the inner needle 36 overlap to form a multi-needle 40.
- the base end of the inner needle 36 is fixed to the needle holding portion 38.
- the inner needle 36 penetrates the valve body 34.
- the portion of the multi-needle 40 that protrudes from the catheter hub 32 in the tip direction is covered by a tubular protector 42.
- the needle holding part 38 is releasably connected to the catheter hub 32.
- the needle holding part 38 has a base 381 that holds the base end of the inner needle 36, and a pair of engagement arms 382 provided on the side of the base 381. Claws 383 provided at the tip of each engagement arm 382 engage with protrusions 323 provided at the base end of the hub body 321. When the user presses the base end side of the engagement arm 382 inward, the tip side of the engagement arm 382 is displaced outward, making the needle holding part 38 detachable from the catheter hub 32.
- a gripping member 46 that is gripped by the user is fixed to the base end of the needle holding part 38 (base 381) (see FIG. 1).
- the holder 20 holds the base end (catheter hub 32) of the catheter 16.
- the holder 20 has a base portion 50 and a hub holding portion 52.
- the base portion 50 is formed in a flat plate shape.
- the patch 24 is fixed to the base portion 50.
- the hub holding portion 52 is formed in a cylindrical shape, and at least its tip is connected to the base portion 50. The tip of the catheter hub 32 is inserted into the hub holding portion 52. The hub holding portion 52 holds the tip of the catheter hub 32.
- the hub holding portion 52 has a first holding portion 521 into which the tip of the hub body 321 of the catheter hub 32 is inserted, and a second holding portion 522 into which the side port 322 of the catheter hub 32 is inserted.
- the hub holding portion 52 protrudes from the surface 501 of the base portion 50.
- the hub holding portion 52 holds the catheter hub 32 so that the axis AX of the catheter hub 32 (specifically, the axis AX of the hub body 321) is inclined relative to the base portion 50.
- the axis AX of the catheter hub 32 is inclined so as to approach the patch 24 toward the tip.
- the multiple needle 40 (see FIG. 1) held by the catheter hub 32 is also inclined relative to the base portion 50.
- the patch 24 is a sheet-like member having an attachment surface 56 (adhesive surface) to be attached to the body surface of a living organism.
- One side of the patch 24 is the attachment surface 56.
- a part of the surface 24a opposite to the attachment surface 56 is connected to the holder 20 (base portion 50).
- the patch 24 in a plan view of the needle unit 12, the patch 24 is larger than the holder 20. Therefore, the patch 24 protrudes outward from the outer periphery of the holder 20 over its entire circumference.
- the multiple needles 40 and the protector 42 penetrate the opening 58 formed in the patch 24.
- a transparent film-like dressing material 60 is provided on the tip side of the surface 24a of the patch 24. The multiple needles 40 and the protector 42 penetrate the dressing material 60.
- the adhesive body 24 has a first adhesive portion 241 having a first adhesive surface 561, and a second adhesive portion 242 having a second adhesive surface 562.
- the tip side of the adhesive surface 56 of the adhesive body 24 is the first adhesive surface 561.
- the portion of the adhesive surface 56 adjacent to the base end side of the first adhesive surface 561 is the second adhesive surface 562.
- the first adhesive portion 241 extends at least above the catheter body 30.
- a portion of the surface 242a opposite the second adhesive surface 562 is connected to the holder 20.
- the release sheet 28 is placed on the attachment surface 56 so as to cover the patch 24.
- the release sheet 28 can be peeled off from the attachment surface 56.
- the release sheet 28 has a first sheet 281 that covers the first attachment surface 561 and a second sheet 282 that covers the second attachment surface 562.
- protrusions 62 that protrude from the patch 24 are provided. The user can peel off the first sheet 281 from the patch 24 by pinching the protrusions 62.
- the "width direction" of the needle unit 12 (and its components) refers to the direction perpendicular to the axial direction of the catheter 16 and the thickness direction of the patch 24 (W direction in FIG. 4).
- the "width” refers to the dimension along the widthwise direction.
- the second sheet 282 has an extension portion 70 that extends further in the proximal direction than the adhesive body 24.
- the second sheet 282 has a covering portion 64 that covers the second attachment surface 562, and an operating portion 66 that is folded back in the proximal direction from the tip of the covering portion 64.
- the width of the proximal side of the operating portion 66 is smaller than the width of the tip side of the operating portion 66.
- the operating portion 66 has an extension portion 70.
- the extension portion 70 extends in the proximal direction from the widthwise center of the proximal end of the adhesive body 24.
- the needle holding portion 38 and the extending portion 70 are viewed in the direction from the holder 20 toward the adhesive body 24 (direction A in FIG. 3), at least a portion of the needle holding portion 38 overlaps with the extending portion 70. That is, when the base portion 50 of the holder 20 is horizontally oriented so that the holder 20 is on the upper side and the adhesive body 24 is on the lower side, the extending portion 70 is disposed below at least a portion of the needle holding portion 38.
- the width of the extending portion 70 may be larger or smaller than the width of the needle holding portion 38 (the width including the pair of engagement arms 382), or may be the same (in the illustrated example, the width of the extending portion 70 is slightly larger than the width of the needle holding portion 38).
- the width of the extending portion 70 is, for example, 50% to 150% of the width of the needle holding portion 38. Note that the extending portion 70 may have a width more than twice that of the needle holding portion 38, as shown by the extending portion 70 in phantom lines in FIG. 1.
- the needle unit 12 further includes a tube 74 and a connector portion 76.
- the tube 74 is flexible. One end of the tube 74 is connected and fixed to the side port 322 of the catheter hub 32.
- the connector portion 76 is connected and fixed to the other end of the tube 74.
- the adapter member 80 In the initial state of the needle unit 12, the adapter member 80 is releasably connected to the base end of the connector portion 76.
- a priming liquid delivery device e.g., a syringe, etc.
- the adapter member 80 has a pair of connection arms 82. Claw portions 84 provided at the tip of each connection arm 82 engage with the side of the connector portion 76. When the user presses the base end side of the connection arm 82 inward, the tip side of the connection arm 82 is displaced outward, making it possible for the adapter member 80 to be detached from the connector portion 76.
- the connector portion 76 in a state in which the adapter member 80 has been detached can be connected to the device main body 14.
- the device body 14 is a device for supplying medicinal liquid toward the needle unit 12.
- the device body 14 includes a medicinal liquid container that stores the medicinal liquid, a gasket that is slidably disposed within the medicinal liquid container, a moving mechanism that moves the gasket toward the tip to deliver the medicinal liquid from the medicinal liquid container, a control unit that controls the moving mechanism, and a power supply unit that supplies power to the moving mechanism, etc.
- the device body 14 further includes a connection unit 141 that can be connected to the connector unit 76 of the needle unit 12.
- the drug solution administration device 10 is used as follows.
- the user connects a priming fluid delivery device (not shown) to the adapter member 80 and delivers priming fluid, filling the inside of the tube 74 and the catheter hub 32 with priming fluid (first priming).
- a priming fluid delivery device (not shown) to the adapter member 80 and delivers priming fluid, filling the inside of the tube 74 and the catheter hub 32 with priming fluid (first priming).
- the user removes the inner needle 36 from the catheter 16. Specifically, the user operates the pair of engagement arms 382 of the needle holding portion 38 to release the engagement between the engagement arms 382 and the catheter hub 32, and pulls the needle member 18 (the inner needle 36 and the needle holding portion 38) in the proximal direction relative to the catheter 16 to remove the inner needle 36 from the catheter 16.
- the user grasps the extension 70 of the second sheet 282, peels the second sheet 282 off the second attachment portion 242 of the adhesive body 24, and attaches the second attachment surface 562 to the body surface.
- the user pulls the extension 70 in the base end direction to peel the second sheet 282 off the second attachment portion 242.
- the covering portion 64 see FIG. 4
- the covering portion 64 of the second sheet 282 is peeled off from the tip side and is turned over sequentially in the base end direction, until the entire covering portion 64 of the second sheet 282 is peeled off from the second attachment portion 242.
- the user can attach the second attachment surface 562 to the body surface while peeling off the second sheet 282.
- the user performs a second priming by discharging priming liquid using a priming liquid discharging device (not shown).
- the catheter body 30 is filled with priming liquid.
- the user connects the needle unit 12 to the device body 14 by connecting the connector portion 76 to the device body 14. Specifically, the user operates the pair of connection arms 82 of the adapter member 80 to disengage the connection arms 82 from the connector portion 76, and then removes the adapter member 80 from the connector portion 76. Next, the user connects the connector portion 76, with the adapter member 80 removed, to the connection portion 141 of the device body 14.
- the holder 20 adheresive body 24
- the holder 20 adheresive body 24
- wrinkles may form on the adhesive body 24 during the removal operation of the inner needle 36, resulting in insufficient attachment to the body surface.
- the adhesive body 24 is not attached to the body surface sufficiently, the adhesive body 24 may peel off from the body surface and the catheter 16 may come out of the living body.
- the needle holding portion 38 and the extension portion 70 are viewed in the direction from the holder 20 toward the adhesive body 24, at least a part of the needle holding portion 38 overlaps with the extension portion 70.
- the user can more easily see the needle holding portion 38 than the extension portion 70 of the release sheet 28 before attaching the adhesive body 24 to the body surface. This makes it difficult for the user to apply the patch 24 to the body surface before removing the inner needle 36 from the catheter 16. As a result, by applying the patch 24 to the body surface after removing the inner needle 36 from the catheter 16, it becomes possible to stably place the catheter 16.
- the adhesive body 24 comprises a first adhesive portion 241 having a first adhesive surface 561 and a second adhesive portion 242 having a second adhesive surface 562.
- the release sheet 28 comprises a first sheet 281 covering the first adhesive surface 561 and a second sheet 282 covering the second adhesive surface 562, and the second sheet 282 has an extension portion 70.
- the second sheet 282 has a covering portion 64 that covers the second attachment surface 562, and an operating portion 66 that is folded back from the tip of the covering portion 64 in the base end direction, and the operating portion 66 has an extension portion 70.
- the second sheet 282 since the second sheet 282 is folded back at the tip position of the second attachment surface 562, the second sheet 282 can be easily peeled off by pulling the extension portion 70 in the base end direction.
- the holder 20 has a base 50 to which the patch 24 is fixed, and a hub holding portion 52 into which the tip of the catheter hub 32 is inserted and which holds the tip of the catheter hub 32.
- the hub holding portion 52 holds the catheter hub 32 so that the axis AX of the catheter hub 32 is inclined relative to the base 50.
- a connecting portion 78 may be formed to releasably connect the needle holding portion 38 and the extension portion 70.
- the connecting portion 78 may be bonded by adhesion, fusion, or the like.
- the holder 20 cannot be attached to the body surface unless the connecting portion 78 is released. Therefore, by providing the connecting portion 78, it is possible to more easily avoid attaching the holder 20 to the body surface before removing the inner needle 36.
- the second sheet 282A has a curved slit 285.
- the second sheet 282A is formed in a spiral shape along the curved slit 285.
- One end of the spiral shape of the second sheet 282A on the outer periphery side protrudes in the proximal direction from the patch 24 to form the extension 70A.
- the needle holding portion 38 and the extension 70A when the needle holding portion 38 and the extension 70A are viewed in the direction from the holder 20 toward the patch 24, at least a part of the needle holding portion 38 overlaps with the extension 70A. Even when the second sheet 282A is formed in a spiral shape in this way, the second sheet 282A can be easily peeled off from the patch 24 by pulling the extension 70A in the proximal direction.
- the present invention is not limited to the above disclosure, and various configurations may be adopted without departing from the gist of the present invention.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Ce dispositif d'administration de solution de médicament (10) comprend un cathéter (16), un élément d'aiguille (18) ayant une aiguille interne (36) et une unité de maintien d'aiguille (38), un support (20) pour supporter la section d'extrémité de base du cathéter (16), un corps de fixation (24), et une feuille de libération (28) chevauchée par une surface de fixation (56). La feuille de libération (28) a une partie d'extension (70) s'étendant davantage dans la direction d'extrémité de base que le corps de fixation (24). Lorsque l'unité de maintien d'aiguille (38) et la partie d'extension (70) sont vues dans la direction allant du support (20) vers le corps de fixation (24), au moins une partie de l'unité de maintien d'aiguille (38) chevauche la partie d'extension (70).
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2024574251A JPWO2024161676A1 (fr) | 2023-01-31 | 2023-07-05 | |
| CN202380090163.0A CN120456950A (zh) | 2023-01-31 | 2023-07-05 | 给药液装置 |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023012385 | 2023-01-31 | ||
| JP2023-012385 | 2023-01-31 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024161676A1 true WO2024161676A1 (fr) | 2024-08-08 |
Family
ID=92146040
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/JP2023/024881 Ceased WO2024161676A1 (fr) | 2023-01-31 | 2023-07-05 | Dispositif d'administration de solution de médicament |
Country Status (3)
| Country | Link |
|---|---|
| JP (1) | JPWO2024161676A1 (fr) |
| CN (1) | CN120456950A (fr) |
| WO (1) | WO2024161676A1 (fr) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001046506A (ja) * | 1999-08-10 | 2001-02-20 | Terumo Corp | 血管内留置カテーテル |
| JP2001523484A (ja) * | 1997-11-14 | 2001-11-27 | ベネテック インターナショナル インコーポレイテッド | 医療用ライン固定器具 |
| JP2004520859A (ja) * | 2000-08-03 | 2004-07-15 | ベネテック インターナショナル インコーポレイテッド | 透析用カテーテルアンカリングシステム |
| JP2007111537A (ja) * | 2005-10-19 | 2007-05-10 | Animas Corp | 安全注入セット |
| JP2009533085A (ja) * | 2006-04-07 | 2009-09-17 | ヴェネテック インターナショナル,インコーポレイテッド | サイドロード式固定デバイス |
| WO2022107244A1 (fr) * | 2020-11-18 | 2022-05-27 | テルモ株式会社 | Aiguille à demeure |
-
2023
- 2023-07-05 CN CN202380090163.0A patent/CN120456950A/zh active Pending
- 2023-07-05 WO PCT/JP2023/024881 patent/WO2024161676A1/fr not_active Ceased
- 2023-07-05 JP JP2024574251A patent/JPWO2024161676A1/ja active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001523484A (ja) * | 1997-11-14 | 2001-11-27 | ベネテック インターナショナル インコーポレイテッド | 医療用ライン固定器具 |
| JP2001046506A (ja) * | 1999-08-10 | 2001-02-20 | Terumo Corp | 血管内留置カテーテル |
| JP2004520859A (ja) * | 2000-08-03 | 2004-07-15 | ベネテック インターナショナル インコーポレイテッド | 透析用カテーテルアンカリングシステム |
| JP2007111537A (ja) * | 2005-10-19 | 2007-05-10 | Animas Corp | 安全注入セット |
| JP2009533085A (ja) * | 2006-04-07 | 2009-09-17 | ヴェネテック インターナショナル,インコーポレイテッド | サイドロード式固定デバイス |
| WO2022107244A1 (fr) * | 2020-11-18 | 2022-05-27 | テルモ株式会社 | Aiguille à demeure |
Also Published As
| Publication number | Publication date |
|---|---|
| JPWO2024161676A1 (fr) | 2024-08-08 |
| CN120456950A (zh) | 2025-08-08 |
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