WO2024032686A1 - Dispositif d'administration de médicament à fonction anti-piqûre - Google Patents

Dispositif d'administration de médicament à fonction anti-piqûre Download PDF

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Publication number
WO2024032686A1
WO2024032686A1 PCT/CN2023/112122 CN2023112122W WO2024032686A1 WO 2024032686 A1 WO2024032686 A1 WO 2024032686A1 CN 2023112122 W CN2023112122 W CN 2023112122W WO 2024032686 A1 WO2024032686 A1 WO 2024032686A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
push rod
cartridge
medicine
delivery device
Prior art date
Application number
PCT/CN2023/112122
Other languages
English (en)
Chinese (zh)
Inventor
杜天虎
Original Assignee
泰尔茂医疗产品(杭州)有限公司
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 泰尔茂医疗产品(杭州)有限公司 filed Critical 泰尔茂医疗产品(杭州)有限公司
Publication of WO2024032686A1 publication Critical patent/WO2024032686A1/fr

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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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention relates to the technical field of medical devices, and in particular to a medicine delivery device with an anti-needle function.
  • Needle injuries are a serious threat to public health and can lead to the spread of diseases, such as HIV or hepatitis, often requiring people to be quarantined for considerable periods of time.
  • diseases such as HIV or hepatitis
  • it may cause psychological and physical trauma to the person, followed by a high degree of damage and serious economic burden. Therefore, cross-infection caused by needlestick injuries is unacceptable.
  • Needle injuries occur throughout the entire life cycle of medical devices. The emphasis on the risk of needle injuries has made the public want various types of safety systems to minimize the possibility of needle injuries by recycling needles or covering needles after use.
  • the general approach is to first use a hollow needle to establish a channel to accommodate the pharmaceuticals in the abdominal wall of the human body, and then transport the pharmaceuticals into the body. There may be cases where the pharmaceuticals cannot be accurately and completely entered into the target location in the body, or the injection You may be injured by needles during and after the procedure.
  • an existing technical solution is to manually push a metal rod out from the inside of a hollow needle so that the top of the metal rod exposes the needle tip for a certain distance.
  • This combination of mechanisms can only protect against axial punctures. It cannot protect against scratches caused by the exposed needle tip, and the surface of the top of the metal rod will also enter the patient's body during the drug implantation process, which will produce blood-borne contamination and may cause infection.
  • the object of the present invention is to provide a drug delivery device with an anti-needle function, which is used to implant linear solid drugs into the patient's body.
  • the drug delivery device can effectively ensure that the injection is completed.
  • the hollow needle retreats back into the device to prevent accidents such as needle stick injuries caused by accidentally pushing the hollow needle out of the device.
  • a drug delivery device with anti-needle puncture function including: a drug cartridge having a proximal end, a distal end and a cavity between the proximal end and the distal end for containing a solid implanted drug a chamber; a hollow needle, fixed to the proximal end of the cartridge and communicated with the chamber; a push rod assembly, installed to the distal end of the cartridge, used to push the solid implant agent into the hollow needle in the chamber; and a sleeve
  • the sleeve is sleeved on the cartridge.
  • the sleeve includes an upper sleeve and a lower sleeve that are connected to each other.
  • the cartridge can slide in the sleeve, and a spring is provided between the sleeve and the cartridge; wherein, the upper sleeve is provided with a To lock the activating buckle of the cartridge, when the push rod assembly pushes the solid implant medicine into the hollow needle, the push rod assembly pushes the activating buckle to release the cartridge, so that the cartridge drives the hollow needle relative to the spring under the action of the spring.
  • the sleeve moves upward to inject the solid implanted medicine out of the hollow needle; wherein, the lower sleeve is provided with a limiting buckle for limiting the downward movement of the drug cartridge relative to the sleeve to prevent the hollow needle from exposing the sleeve.
  • the push rod assembly includes a push rod seat and a push rod connected to the push rod seat.
  • a limiting clip for limiting the movement of the push rod seat is provided between the push rod seat and the sleeve.
  • the push rod seat is provided with a locking buckle for locking the cartridge to the push rod seat.
  • the locking buckle has a locking buckle surface extending obliquely toward the central axis of the push rod seat.
  • the push rod base has a pushing part for pushing the starting buckle, the pushing part has an outer inclined surface, and the starting buckle has an inner inclined surface matching the outer inclined surface of the pushing part.
  • the lower sleeve is also provided with a baffle for limiting the upward movement of the cartridge relative to the sleeve.
  • a flange is provided on the outer periphery of the cartridge, and the flange can be locked between the baffle of the lower sleeve and the limiting buckle.
  • the limiting buckle has a limiting buckling surface extending obliquely toward the central axis of the sleeve.
  • the medicine delivery device further includes a sheath placed on the outside of the hollow needle.
  • the drug delivery device according to the present invention is mainly used for infusion of long-acting and sustained-release solid preparations.
  • the upper sleeve is provided with an activation buckle for locking the medicine cartridge.
  • the push rod assembly pushes the solid implanted medicine into the hollow needle
  • the push rod assembly pushes the activation buckle to lock the medicine cartridge.
  • the cartridge is released, so that the cartridge drives the hollow needle to move upward relative to the sleeve under the action of the spring, so as to inject the solid implant medicine out of the hollow needle.
  • Embodiments of the present invention use hollow needles to establish a stable and reliable tunnel for accommodating solid implanted medicaments in the abdominal wall of the human body, and transport the solid implanted medicaments to the interior close to the needle tip of the hollow needle, ensuring that the medicaments can completely enter the target human body. position, then in The empty needle retreats into the device, while the solid implanted agent stays in the tunnel and is subsequently released. There is no risk of needle exposure during the entire process, and accidents such as needle stick injuries are avoided.
  • the lower sleeve is provided with a limiting buckle for limiting the downward movement of the cartridge relative to the sleeve to prevent the hollow needle from being exposed from the sleeve, thus preventing the operator from accidentally pushing the push rod assembly and causing the hollow needle to be exposed from the sleeve. Accidents such as needle stick injuries may occur.
  • the push rod assembly includes a push rod seat and a push rod connected to the push rod seat.
  • a limiting clip for limiting the movement of the push rod seat is provided between the push rod seat and the sleeve. Before use, the movement of the push rod seat is limited by the limiting clip to prevent the solid implant agent from being pushed into the hollow needle due to accidental pushing of the push rod seat.
  • the push rod seat is provided with a locking buckle for locking the cartridge to the push rod seat.
  • the cartridge is locked to the push rod seat through the locking buckle, thereby realizing the interlocking of the cartridge and the push rod seat.
  • the lower sleeve is also provided with a baffle for limiting the upward movement of the cartridge relative to the sleeve.
  • the outer periphery of the cartridge is provided with a flange, and the flange can be locked between the baffle of the lower sleeve and the limiting buckle.
  • the baffle and the limit buckle Through the cooperation of the baffle and the limit buckle, the movement of the cartridge is limited so that the cartridge can neither move upward nor downward, thus avoiding the accidental pushing of the hollow needle out of the device.
  • Figure 1 shows a schematic diagram of a medicament delivery device according to one embodiment of the present invention
  • Figure 2 shows a schematic cross-sectional view of the medicament delivery device of the embodiment shown in Figure 1;
  • FIG 3 shows a schematic diagram of the use process of the medicine delivery device of the embodiment shown in Figure 1, in which the push rod assembly pushes the activation buckle to release the medicine cartridge;
  • Figure 4 shows a schematic diagram of the use process of the medicine delivery device of the embodiment shown in Figure 1, in which the medicine cartridge pushes the locking buckle outward under the action of the spring;
  • Figure 5 shows a schematic diagram of the use process of the medicine delivery device of the embodiment shown in Figure 1, in which the locking buckle rebounds to lock the cartridge to the push rod seat;
  • Figure 6 shows a schematic diagram of the use process of the medicine delivery device of the embodiment shown in Figure 1, in which the limiting buckle limits the downward movement of the medicine cartridge;
  • Figure 7 shows a schematic view of the drug delivery device of the embodiment shown in Figure 1 after use, with the hollow needle withdrawn into the interior of the device.
  • the medicine delivery device 100 includes a medicine cartridge 10 , a hollow needle 20 , a push rod assembly 30 and a sleeve 40 .
  • the cartridge 10 has a proximal end 11 , a distal end 12 and a chamber 13 located between the proximal end 11 and the distal end 12 for accommodating the solid implanted medicament 50 .
  • the distal end 12 is provided with a cartridge plug 14 that closes the chamber 13 .
  • the hollow needle 20 is fixed to the proximal end 11 of the cartridge 10 and communicates with the chamber 13 .
  • the hollow needle 20 has a needle tube 21 and a needle tip 22.
  • the needle tube 21 is connected with the chamber 13.
  • the needle tip 22 is used to penetrate, for example, the abdominal wall of a human body to establish a tunnel to accommodate the solid implanted medicine 50.
  • the push rod assembly 30 is mounted to the distal end 12 of the cartridge 10 for pushing the solid implanted medicament 50 into the hollow needle 20 within the chamber 13 .
  • the push rod assembly 30 includes a push rod base 31 and a push rod 32 connected to the push rod base 31.
  • a limiting clip 33 is provided between the push rod base 31 and the sleeve 40 for limiting the movement of the push rod base 31.
  • the movement of the push rod base 31 is limited by the limiting clip 33 to prevent the solid implantation of medicine due to accidental pushing of the push rod base 31. 50 push into the hollow needle 20.
  • One end of the push rod 32 is fixed to the center of the push rod seat 31 in a known manner, and the other end extends through the cartridge plug 14 into the chamber 13 of the cartridge 10 to facilitate pushing the solid implanted medicine 50 in the chamber 13 Move down inside.
  • moving upward refers to the movement of the cartridge 10 in the sleeve 40 toward the push rod assembly 30
  • moving downward refers to the movement of the cartridge 10 in the sleeve 40 toward the hollow needle 20 , that is, move away from the push rod assembly 30 .
  • the sleeve 40 is sleeved on the outside of the cartridge 10.
  • the sleeve 40 includes an upper sleeve 41 and a lower sleeve 42.
  • the inner diameter of the upper sleeve 41 is larger than the inner diameter of the lower sleeve 42.
  • the upper sleeve 41 is used to accommodate the push rod assembly.
  • the push rod seat 31 of 30 and the lower sleeve 42 are used to accommodate the cartridge 10.
  • the upper sleeve 41 and the lower sleeve 42 can be two separate parts connected to each other in a known manner, or they can be integrally formed by, for example, injection molding.
  • two symmetrical grooves are provided on the outer circumference of the upper sleeve 41, and two symmetrical protrusions are provided on the outer circumference of the lower sleeve 42.
  • the cartridge 10 can slide upward and downward relative to the sleeve 40 in the sleeve 40.
  • a spring 60 is provided between the upper sleeve 41 of the sleeve 40 and the cartridge 10. When the cartridge 10 is installed into the sleeve 40 , spring 60 is in a compressed state.
  • the upper sleeve 41 is provided with an activating buckle 411 for locking the cartridge 10.
  • the upper sleeve 41 is provided with two symmetrically arranged activating buckles 411.
  • the activating buckles 411 can be, for example, elastic formed on the upper sleeve 41. In the form of arms or elastic sheets.
  • the push rod base 31 of the push rod assembly 30 pushes the activating buckle 411, and expands the activating buckle 411 outward to release the cartridge 10, so that
  • the medicine cartridge 10 drives the hollow needle 20 to move upward relative to the sleeve 40 under the action of the spring 60 , so that the push rod 32 of the push rod assembly 30 pushes the solid implanted medicine 50 out of the hollow needle 20 .
  • the lower sleeve 42 is provided with a limiting buckle 421 for limiting the downward movement of the cartridge 10 relative to the sleeve 40 to prevent the hollow needle 20 from exposing the sleeve 40 .
  • the push rod base 31 is provided with a locking catch 311 for locking the cartridge 10 to the push rod base 31 .
  • the locking buckle 311 has a central axis facing the push rod seat 31 The locking catch surface 3111 extends obliquely.
  • the push rod base 31 is provided with two symmetrically arranged locking buckles 311 , and the locking buckles 311 may be in the form of elastic arms or elastic sheets formed on the push rod base 31 .
  • the push rod base 31 has a pushing part 312 for pushing the activating buckle 411
  • the pushing part 312 has an outer inclined surface 3121
  • the activating buckle 411 has a pushing part
  • the outer inclined surface 3121 of 312 matches the inner inclined surface 4111, so that the pushing part 312 pushes the activation buckle 411.
  • the push rod base 31 moves downward, the outer inclined surface 3121 of the pushing part 312 slides along the inner inclined surface 4111 of the activating buckle 411, gradually opening the activating buckle 411 outward, thereby releasing the cartridge 10.
  • the lower sleeve 42 is also provided with a baffle 422 for limiting the upward movement of the cartridge 10 relative to the sleeve 40 .
  • a flange 15 is provided on the outer periphery of the cartridge 10 , and the flange 15 can be locked between the baffle 422 of the lower sleeve 42 and the limiting buckle 421 of the lower sleeve 42 .
  • the limiting buckle 421 has a limiting buckling surface 4211 extending obliquely toward the axis of the sleeve 40 .
  • the flange 15 of the cartridge 10 moves upward along the limiting buckle surface 4211, thereby pushing the limiting buckle 421 outward.
  • the limiting buckle 421 rebounds to lock the cartridge 10 between the baffle 422 of the lower sleeve 42 and the limiting buckle 421 of the lower sleeve 42 .
  • the drug delivery device 100 further includes a sheath 70 sheathed on the outside of the hollow needle 20 .
  • the sheath 70 is placed on the outside of the hollow needle 20 to prevent the hollow needle from stabbing the patient or medical staff. The sheath 70 is removed during use.
  • spring 60 when spring 60 is fully released, hollow needle 20 is fully retracted into sleeve 40.
  • the center The distance between the end of the empty needle 20 and the end of the lower sleeve 42 of the sleeve 40 is 2 mm to 10 mm.
  • the cartridge 10 slides axially upward along the push rod 32.
  • the cartridge 10 pushes against the locking buckle 311 of the push rod seat 31 and continues to slide.
  • the locking buckle 311 resumes its deformation, thereby achieving Interlocking of cartridge 10 and push rod seat 31.
  • the solid implanted medicine 50 is restricted by the push rod 32 and does not retreat, and the hollow needle 20 retreats into the sleeve 40 along with the cartridge 10.
  • the solid implanted medicine 50 is exposed from the needle tube 21 of the hollow needle 20 and enters the patient. subcutaneous.
  • the limit buckle 421 rebounds to block the downward movement of the cartridge 10, and at the same time the baffle 422 blocks the upward movement of the cartridge 10, so that the cartridge 10 can neither move upward nor downward, thereby avoiding the accidental movement of the hollow needle. Push out the device. At this time, the needle tip 22 of the hollow needle 20 is completely retracted into the lower sleeve 42 of the sleeve 40 .
  • the upper sleeve is provided with an activation buckle for locking the medicine cartridge.
  • the push rod assembly pushes the solid implanted medicine into the hollow needle
  • the push rod assembly pushes the activation buckle to lock the medicine cartridge.
  • the hollow needle moves upward relative to the sleeve to inject the solid implant agent out of the hollow needle.
  • Embodiments of the present invention use hollow needles to establish a stable and reliable tunnel for accommodating solid implanted medicaments in the abdominal wall of the human body, and transport the solid implanted medicaments to the interior close to the needle tip of the hollow needle, ensuring that the medicaments can completely enter the target human body. position, and then the hollow needle retreats into the interior of the device, while the solid implant agent stays in the tunnel. There is no risk of needle exposure during the entire process, and accidents such as needle stick injuries are avoided.
  • the lower sleeve is provided with a limiting buckle for limiting the downward movement of the cartridge relative to the sleeve to prevent the hollow needle from being exposed from the sleeve, thus preventing the operator from accidentally pushing the push rod assembly and causing the hollow needle to be exposed from the sleeve. Accidents such as needle stick injuries may occur.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif d'administration de médicament ayant une fonction anti-piqûre, comprenant : un cylindre de médicament, pourvu d'une extrémité proximale, d'une extrémité distale, et d'une chambre située entre l'extrémité proximale et l'extrémité distale et conçue pour recevoir un médicament d'implantation solide ; une aiguille creuse, fixée à l'extrémité proximale du cylindre de médicament et en communication avec la chambre ; un ensemble tige de poussée, installé à l'extrémité distale du cylindre de médicament et conçu pour pousser le médicament d'implantation solide dans la chambre pour entrer dans l'aiguille creuse ; et un manchon, manchonnant le cylindre de médicament, le manchon comprenant un manchon supérieur et un manchon inférieur qui sont reliés l'un à l'autre. Le cylindre de médicament peut coulisser dans le manchon, et un ressort est agencé entre le manchon et le cylindre de médicament. Le manchon supérieur est pourvu d'une boucle de départ conçue pour verrouiller le cylindre de médicament. Le manchon inférieur est pourvu d'une boucle de limitation conçue pour limiter le mouvement vers le bas du cylindre de médicament par rapport au manchon de façon à empêcher l'aiguille creuse d'être exposée hors du manchon. Selon le dispositif d'administration de médicament de la présente invention, lorsque le médicament d'implantation solide est implanté dans le corps humain d'un patient, il peut être garanti que l'aiguille creuse revienne à l'intérieur du dispositif, et l'aiguille creuse est empêchée d'être poussée accidentellement hors du dispositif, ce qui permet d'éviter efficacement des accidents tels qu'une lésion par piqûre.
PCT/CN2023/112122 2022-08-10 2023-08-10 Dispositif d'administration de médicament à fonction anti-piqûre WO2024032686A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202222095575.9 2022-08-10
CN202222095575.9U CN219050059U (zh) 2022-08-10 2022-08-10 带有防针刺功能的药剂输送装置

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117771475A (zh) * 2024-02-27 2024-03-29 山东永聚医药科技股份有限公司 固体制剂用植入式预灌封注射器及其制备方法

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN219050059U (zh) * 2022-08-10 2023-05-23 泰尔茂医疗产品(杭州)有限公司 带有防针刺功能的药剂输送装置
CN219167472U (zh) * 2022-08-10 2023-06-13 泰尔茂医疗产品(杭州)有限公司 带有自动防护装置的药剂输送装置

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4105030A (en) * 1977-01-03 1978-08-08 Syntex (U.S.A.) Inc. Implant apparatus
DE202007006483U1 (de) * 2007-05-07 2007-07-12 Rexam Pharma Gmbh Spritzenvorrichtung mit einem länglichen Kolbenraum
US20090182267A1 (en) * 2007-12-21 2009-07-16 Gaetan Painchaud Device for injecting an implant
CN106806963A (zh) * 2015-11-30 2017-06-09 江苏天士力帝益药业有限公司 一种固体药物注射器
CN109982733A (zh) * 2016-08-05 2019-07-05 印度商巴拉特赛罗姆斯暨菲凯因斯股份有限公司 一种基于保护壳体的植入物/药剂注射系统
CN219050059U (zh) * 2022-08-10 2023-05-23 泰尔茂医疗产品(杭州)有限公司 带有防针刺功能的药剂输送装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4105030A (en) * 1977-01-03 1978-08-08 Syntex (U.S.A.) Inc. Implant apparatus
DE202007006483U1 (de) * 2007-05-07 2007-07-12 Rexam Pharma Gmbh Spritzenvorrichtung mit einem länglichen Kolbenraum
US20090182267A1 (en) * 2007-12-21 2009-07-16 Gaetan Painchaud Device for injecting an implant
CN106806963A (zh) * 2015-11-30 2017-06-09 江苏天士力帝益药业有限公司 一种固体药物注射器
CN109982733A (zh) * 2016-08-05 2019-07-05 印度商巴拉特赛罗姆斯暨菲凯因斯股份有限公司 一种基于保护壳体的植入物/药剂注射系统
CN219050059U (zh) * 2022-08-10 2023-05-23 泰尔茂医疗产品(杭州)有限公司 带有防针刺功能的药剂输送装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117771475A (zh) * 2024-02-27 2024-03-29 山东永聚医药科技股份有限公司 固体制剂用植入式预灌封注射器及其制备方法
CN117771475B (zh) * 2024-02-27 2024-05-10 山东永聚医药科技股份有限公司 固体制剂用植入式预灌封注射器及其制备方法

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