WO2023137602A1 - Injecteur - Google Patents

Injecteur Download PDF

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Publication number
WO2023137602A1
WO2023137602A1 PCT/CN2022/072622 CN2022072622W WO2023137602A1 WO 2023137602 A1 WO2023137602 A1 WO 2023137602A1 CN 2022072622 W CN2022072622 W CN 2022072622W WO 2023137602 A1 WO2023137602 A1 WO 2023137602A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide tube
pushing
housing
tube
glaucoma drainage
Prior art date
Application number
PCT/CN2022/072622
Other languages
English (en)
Chinese (zh)
Inventor
阚敏
汤国兵
王琰
Original Assignee
苏州朗目医疗科技有限公司
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 苏州朗目医疗科技有限公司 filed Critical 苏州朗目医疗科技有限公司
Priority to PCT/CN2022/072622 priority Critical patent/WO2023137602A1/fr
Publication of WO2023137602A1 publication Critical patent/WO2023137602A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a push injector.
  • Glaucoma is a group of diseases characterized by optic disc atrophy and depression, visual field defect and vision loss. Pathological increased intraocular pressure and optic nerve insufficiency are the primary risk factors for its onset. The tolerance of optic nerve to pressure damage is also related to the occurrence and development of glaucoma. Obstacles in any part of the aqueous humor circulation pathway can lead to pathological changes caused by elevated intraocular pressure, but some patients also present with normal intraocular pressure glaucoma. Glaucoma is one of the three major blindness diseases that cause blindness in humans, with an incidence rate of 1% in the general population and 2% after the age of 45. Clinically, glaucoma is divided into three categories: primary, secondary, and congenital according to the etiology, anterior chamber angle, and intraocular pressure tracings.
  • drainage implants are usually implanted inside the eyes of the human body to reconstruct the outflow channel of aqueous humor, thereby reducing intraocular pressure to achieve therapeutic purposes. Drainage implants are usually implanted into the schlemm canal by a doctor by hand. This implantation method has the problems of inaccurate positioning and poor implantation effect.
  • the injectors currently on the market are implanted through the internal route (a part of the injector enters the schlemm tube to implant the drainage implant), which is complicated and depends on the experience of clinicians, and the operation time is relatively long.
  • the invention provides a pusher, which solves the problems of inaccurate positioning and poor implantation effect of glaucoma drainage implants in the prior art.
  • a technical solution adopted by the present invention is to provide a injector for pushing the glaucoma drainage implant into the schlemm tube, including a housing, a guide tube, a pushing mechanism, and a push wire; the guide tube is connected to the housing, and its distal end is used to accommodate the glaucoma drainage implant; Mechanism connection; the pushing mechanism is at least partially exposed to the housing, and is used to provide a pushing force to the pushing wire so that the glaucoma drainage implant is pushed into the schlemm tube along the guide tube, and during the pushing process of the pushing mechanism, the distal end of the guide tube abuts against the outside of the schlemm tube.
  • the pushing mechanism includes a fixed frame and a main gear, an intermediate gear, and a pushing rack mounted on the fixed frame;
  • the main gear is at least partly exposed to the housing to form a knob, the main gear is in transmission connection with the push rack through the intermediate gear, and the front end of the push rack is connected with a fixing block for fixing the push wire.
  • the guide tube includes a curved guide tube at a distal end and a straight guide tube connected to the curved guide tube.
  • the curved guide tube includes a first curved guide tube and a second curved guide tube, and the second curved guide tube is connected to the straight guide tube.
  • an anti-trigger mechanism is provided on the side of the housing, and the anti-trigger mechanism is used to limit the movement of the push rack.
  • the anti-trigger mechanism is a limit pin, and the limit pin passes through the housing and the push rack.
  • the front end of the housing is provided with a guide tube protection sleeve, the guide tube runs through the guide tube protection sleeve, and the tail of the guide tube protection sleeve is installed in the housing.
  • a guide tube fixing sleeve is provided inside the guide tube protective sleeve, the proximal end of the guide tube passes through the guide tube fixing sleeve, and the outer wall of the guide tube is fixedly connected to the guide tube fixing sleeve.
  • the head of the housing is covered with a plurality of anti-slip rubber rings.
  • the housing includes a first housing and a second housing that are detachably connected.
  • the present invention discloses a push injector, which is used to push the glaucoma drainage implant into the schlemm tube, including a housing, a guiding tube, a pushing mechanism, and a pushing wire;
  • the guiding tube is connected to the housing, and its distal end is used to accommodate the glaucoma drainage implant, and the pushing wire is arranged inside the guiding tube;
  • the wire provides a pushing force so that the glaucoma drainage implant is pushed into the schlemm tube along the guide tube, and during the pushing process of the pushing mechanism, the distal end of the guide tube abuts against the outside of the schlemm tube.
  • the injector in the present application has good pushing effect, high precision and is convenient for operators to use.
  • Fig. 1 is the use schematic diagram of a kind of injector according to the present invention
  • Fig. 2 is a schematic diagram of the abutment process between the guide tube in the injector and the schlemm tube of the human eye according to the present invention
  • Fig. 3 is the overall schematic diagram of a kind of injector according to the present invention.
  • Fig. 4 is an exploded schematic view of a injector according to the present invention.
  • Fig. 5 is a schematic diagram of a first embodiment of a guide tube in a syringe according to the present invention
  • Fig. 6 is an overall schematic diagram of a second embodiment of a guide tube in a syringe according to the present invention.
  • Fig. 7 is an exploded schematic diagram of a second embodiment of a guide tube in a syringe according to the present invention.
  • Fig. 8 is an overall schematic diagram of a pushing mechanism in a syringe according to the present invention.
  • Fig. 9 is an exploded schematic diagram of a pushing mechanism in a syringe according to the present invention.
  • Fig. 10 is a schematic diagram of a guide tube protective sleeve and a guide tube fixing sleeve in a syringe according to the present invention
  • Fig. 11 is a schematic diagram of a second housing in a syringe according to the present invention.
  • the injector is used to push the glaucoma drainage implant 5 into the schlemm canal, and the glaucoma drainage implant 5 can rebuild the outflow channel of aqueous humor, thereby reducing intraocular pressure to achieve therapeutic purposes.
  • a glaucoma drainage implant 5 Before the injection of the glaucoma drainage implant 5 , an operation incision is first made on the schlemm tube, so that two nozzles will be produced on the schlemm tube. Then, the distal end of the guide tube 2 of the injector is abutted against the outside of the schlemm tube, that is, the distal end of the guide tube 2 is kept coaxially flush with the mouth of the schlemm tube, but does not enter the schlemm tube; thereby facilitating the smooth introduction of the glaucoma drainage implant 5 into the schlemm tube; a glaucoma drainage implant 5 can be implanted on both sides of the surgical incision.
  • This method is not only suitable for the operation of open-angle glaucoma, but also can be used for the operation of angle-closure glaucoma.
  • the injector is implanted externally, and the guide tube 2 of the injector does not enter the schlemm tube of the human eye.
  • the operation process is simple, the operation is convenient, the operation time is short, and the patient's eye pain is reduced.
  • the existing bolus is implanted through the internal route, and the guide tube of the bolus will enter the schlemm canal of the human eye.
  • the operation process is complicated and difficult, and the patient will also cause greater pain in the eye during the operation.
  • distal end refers to the end close to the eyeball
  • proximal end refers to the end close to the operator's hand
  • the injector comprises a housing 1, a guide tube 2, a pushing mechanism 3, and a pushing wire 4.
  • the guide tube 2 is connected with the housing 1, and its distal end is used to accommodate the glaucoma drainage implant 5, and the push wire 4 is arranged inside the guide tube 2, and the distal end of the push wire 4 abuts against the glaucoma drainage implant 5, that is, the distal end of the push wire 4 can push the glaucoma drainage implant 5 to expose the guide tube 2, thereby entering the schlemm tube of the human eye.
  • the proximal end of the push wire 4 exposes the proximal end of the guide tube 2 and is connected to the push mechanism 3 inside the housing 1.
  • the push mechanism 3 provides a thrust to the push wire 4, so that the push wire can push the glaucoma drainage implant 5 to expose the guide tube 2, and can also return to the initial position after the push is completed.
  • the pushing mechanism 3 is at least partly exposed from the housing 1 , and is used to provide pushing force to the pushing wire 4 so that the glaucoma drainage implant 5 is pushed into the schlemm canal along the guide tube.
  • the distal end of the guide tube 2 abuts against the outside of the schlemm tube.
  • the far end of the push wire 4 can only push the glaucoma drainage implant 5 out of the guide tube 2 to complete the one-way push; it cannot drive the glaucoma drainage implant 5 back into the guide tube 2.
  • the push wire 4 returns to the inside of the housing 1, the glaucoma drainage implant 5 is in a static state and does not move.
  • the guide tube 2 includes a curved guide tube 21 at the distal end and a straight guide tube 22 connected to the curved guide tube 21 .
  • the curved guide tube 21 is matched with the glaucoma drainage implant 5 and the schlemm tube of the human eye, thereby facilitating the introduction of the glaucoma drainage implant 5
  • the straight guide tube 22 is connected with the housing 1 .
  • the curved guide tube 21 includes a first curved guide tube 211 and a second curved guide tube 212 , and the second curved guide tube 212 is connected to the straight guide tube 22 .
  • the glaucoma drainage implants 5 which are accommodated in the first curved guide tube 211.
  • the glaucoma drainage implant 5 abuts against the distal end of the push wire 4; the push wire 4 is partly accommodated inside the guide tube 2, and the overall shape of the push wire 4 is consistent with the overall shape of the guide tube 2, which is convenient for pushing.
  • the guide tube 2 has good biocompatibility, and its material can be stainless steel, such as 2Cr13, 1Cr13, 1Cr18Ni9, SUS304(L), SUS316(L), SUS430, etc.; it can also be titanium alloy, such as TC4, etc.; it can also be pure titanium, tungsten steel, platinum, platinum-iridium alloy, polymer materials, and modified engineering plastics.
  • stainless steel such as 2Cr13, 1Cr13, 1Cr18Ni9, SUS304(L), SUS316(L), SUS430, etc.
  • titanium alloy such as TC4, etc.
  • it can also be pure titanium, tungsten steel, platinum, platinum-iridium alloy, polymer materials, and modified engineering plastics.
  • the measurement result of the diameter of the Schlemm tube of the human eye is 0.39mm-0.63mm, and the average value is (0.50 ⁇ 0.07)mm.
  • the shape, size and size of the glaucoma drainage implant 5 are customized according to the Schlemm canal of the human eye, and the diameter of the guide tube 2 matches the glaucoma drainage implant 5 .
  • the diameter of the glaucoma drainage implant 5 ranges from 0.1mm to 0.5mm
  • the length of the glaucoma drainage implant 5 ranges from 1mm to 5mm
  • the curvature range of the glaucoma drainage implant 5 ranges from R4mm to R10mm.
  • the diameter of the inner wall of the guide tube 2 ranges from 0.1 mm to 0.5 mm, and the diameter of the outer wall of the guide tube 2 ranges from 0.1 mm to 1 mm.
  • the curvature of the curved guide tube 21 matches the curvature of the schlemm canal, which facilitates the operator's hands to introduce the glaucoma drainage implant 5 into the schlemm canal at a more comfortable angle.
  • the curvature range of the curved guide tube 21 R4mm-R10mm; in FIG. 6, the curvature range of the first curved guide tube 211: R4mm-R10mm, and the curvature range of the second curved guide tube 212: R3mm-R8mm.
  • the pushing mechanism 3 includes a fixed frame 31 and a main gear 32 , an intermediate gear 33 , and a pushing rack 34 installed on the fixed frame 31 .
  • a first fixed rod 301 and a second fixed rod 302 are arranged on the fixed frame 31 , the main gear 32 can rotate around the first fixed rod 301 , and the intermediate gear 33 can rotate around the second fixed rod 302 .
  • the pushing rack 34 meshes with the intermediate gear 33 and moves forward and backward along the fixed frame 31 .
  • the main gear 32 is at least partly exposed to the housing 1 to form a knob.
  • the main gear 32 can push the glaucoma drainage implant 5 forward in the guide tube 2, and when the main gear 32 is retreating, the glaucoma drainage implant 5 is in a static state.
  • the knob part of the main gear 32 exposed from the housing 1 may be provided with protrusions or depressions, so that the operator can feel the pushing distance of the glaucoma drainage implant 5 during the pushing process.
  • the protrusions or depressions are regularly distributed, which can effectively feedback the travel tactile sensation of the main gear 32; the knob part can also be wrapped with silica gel.
  • the main gear 32 is in transmission connection with the push rack 34 through the intermediate gear 33, and the front end of the push rack 34 is connected with a fixing block 35 for fixing the push wire 4.
  • the proximal end of the push wire 4 passes through the fixed block 35 and bends downwards, and finally is fixedly connected with the fixed block 35.
  • the fixed block 35 is connected with the front end of the push rack 34 by plugging, and a plug post 351 is arranged on the side of the front end of the push rack 34 near the fixed block 35.
  • the working principle of the push mechanism 3 is: after the main gear 32 is moved, the intermediate gear 33 rotates and then drives the push rack 34 to move back and forth, the fixed block 35 moves back and forth synchronously, and then drives the push wire 4 to move back and forth in the guide tube 2 (the guide tube 2 remains stationary); when the push wire 4 moves outward, the glaucoma drainage implant 5 can be pushed out of the guide tube 2.
  • the transmission ratio of the main gear 32 and the intermediate gear 33 is 0.2-5.
  • the transmission ratio of the main gear 32 and the intermediate gear 33 is greater than 1, that is, the rotation speed of the main gear 32 is faster than that of the intermediate gear 33, so it is decelerated.
  • the purpose is to ensure that the glaucoma drainage implant 5 slowly enters the schlemm tube from the guide tube 2 when the operator performs surgery, and also avoids surgical risks caused by some misoperations.
  • the material of the fixing frame 31 may be ABS, POM, PEEK, PVC, PET, nylon, polymer material, modified engineering plastic, zinc alloy, aluminum alloy, magnesium aluminum alloy, stainless steel, copper, iron, etc.
  • the diameter of the push wire 4 is 0.1mm-0.5mm, and the push wire can be made of SUS300 series/SUS400 series stainless steel.
  • an anti-trigger mechanism is provided on the side of the housing 1, and the anti-trigger mechanism is used to limit the movement of the push rack 34, so as to prevent the injector from being triggered due to no action before official use, causing the injector to fail. After removing the structure, it indicates that the injector has been used and cannot be restored, and a reminder is given to the operator.
  • the anti-trigger mechanism is a limit pin 6 , and the limit pin 6 passes through the housing 1 and the push rack 34 .
  • One end of the limit latch 6 is provided with a pinch plate 61, and the setting of the pinch plate 61 facilitates the extraction of the limit latch 6.
  • the anti-trigger mechanism can also be a round rod, a square rod, a metal wire or a string, etc.
  • the front end of the casing 1 is provided with a guide tube protective sleeve 7
  • the guide tube 2 runs through the guide tube protective sleeve 7
  • the tail portion 72 of the guide tube protective sleeve 7 is installed in the housing 1 .
  • the head 71 of the guide tube protective cover 7 is tapered gradually, and colloid can be used between the tip of the head 71 of the guide tube protective cover 7 and the guide tube 2 to prevent the guide tube 2 from shaking.
  • the tail portion 72 of the guide tube protection sleeve 7 is cylindrical, and a limiting block 73 is arranged on the tail portion 72 of the guide tube protection sleeve 7 .
  • the housing 1 includes a first housing 101 and a second housing 102 that are detachably connected, and the detachable connection includes buckling, clamping, threaded connection and the like.
  • the front end of the second housing 102 is provided with a mounting platform 105
  • the mounting platform 105 is provided with a mounting groove 106 for placing the tail portion 72 of the guide tube protective sleeve 7 .
  • the groove wall of the mounting groove 106 is also provided with a corresponding limiting groove 107 that is compatible with the limiting block 73 ;
  • the inside of the guide tube protective sleeve 7 is provided with a guide tube fixing sleeve 8, the proximal end of the guide tube 2 runs through the guide tube fixing sleeve 8, and the outer wall of the guide tube 2 is fixedly connected to the guide fixing sleeve 8, and the fixed connection can be fixed by colloid.
  • the head 81 of the guide tube fixing sleeve 8 is inserted into the tail portion 72 of the guide tube protective sleeve 7, and the head 81 of the guide tube fixing sleeve 8 and the tail portion 72 of the guide tube protective sleeve 7 are fixed by colloid;
  • a plurality of anti-slip rubber rings 104 are sheathed on the head of the housing 1 , and rubber ring grooves 103 for accommodating the anti-slip rubber rings 104 are also provided on the first housing 101 and the second housing 102 .
  • the anti-slip rubber ring 104 is convenient for the operator to grasp, stimulates the operator's senses, and also plays a role in increasing the appearance.
  • the second housing 102 has a flat bottom surface 104 inside, and the flat bottom surface 104 is used to fix the fixing bracket 31 of the pushing mechanism 3 , and the fixing bracket 31 can be glued or ultrasonically welded on the flat bottom surface 104 .
  • a plurality of reinforcing ribs 108 are provided inside the second housing 102, and the reinforcing ribs 108 are used to increase the strength of the housing and prevent easy damage.
  • the position of the first housing 101 close to the main gear 32 is provided with an indicator mark 9, which indicates the pushing direction.
  • the indication mark 9 can be a protrusion, a depression, a silk screen or a sticker.
  • the shape of the housing 1 is large in the middle and small at the two ends, or large at both ends and small at the middle, or a straight rod type, which is suitable for one-handed operation.
  • the diameter of the housing 1 ranges from 5 mm to 20 mm, and the length ranges from 5 cm to 20 cm.
  • the material of the housing 1 can be ABS, POM, PEEK, PVC, PET, nylon, polymer materials, modified engineering plastics, zinc alloy, aluminum alloy, magnesium aluminum alloy, stainless steel, copper, iron, etc.
  • the sterilization methods of the injector may include: gas sterilization (ethylene oxide, formaldehyde, ozone), radiation sterilization (microwave, ultraviolet (UV), X-ray and ⁇ -ray, etc.).
  • the present invention discloses a push injector, which is used to push the glaucoma drainage implant into the schlemm tube, including a housing, a guide tube, a pushing mechanism, and a pusher wire; the guide tube is connected to the housing, and its distal end is used to accommodate the glaucoma drainage implant, and the pusher wire is arranged inside the guide tube; The glaucoma drainage implant is pushed into the schlemm tube along the guide tube, and the distal end of the guide tube abuts against the outside of the schlemm tube during the pushing process of the pushing mechanism.
  • the injector in the present application has good pushing effect, high precision and is convenient for operators to use.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un injecteur, utilisé pour pousser un implant de drainage de glaucome (5) dans un canal de schlemm, comprenant un boîtier (1), un canal de guidage (2), un mécanisme de poussée (3) et un fil de poussée (4). Le canal de guidage (2) est relié au boîtier (1), une extrémité distale du canal de guidage est utilisée pour recevoir l'implant de drainage de glaucome (5) ; le fil de poussée (4) est disposé dans le canal de guidage (2) ; une extrémité distale du fil de poussée (4) vient en butée contre l'implant de drainage de glaucome (5) ; une extrémité proximale du fil de poussée (4) expose une extrémité proximale du canal de guidage (2), et est reliée au mécanisme de poussée (3) dans le boîtier (1) ; au moins une partie du mécanisme de poussée (3) est exposée au boîtier (1), et est utilisée pour fournir une force de poussée pour le fil de poussée (4), de telle sorte que l'implant de drainage de glaucome (5) est poussé dans le canal de schlemm le long du canal de guidage (2) ; et dans le processus de poussée du mécanisme de poussée (3), l'extrémité distale du canal de guidage (2) vient en butée contre l'extérieur du canal de schlemm.
PCT/CN2022/072622 2022-01-18 2022-01-18 Injecteur WO2023137602A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2022/072622 WO2023137602A1 (fr) 2022-01-18 2022-01-18 Injecteur

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2022/072622 WO2023137602A1 (fr) 2022-01-18 2022-01-18 Injecteur

Publications (1)

Publication Number Publication Date
WO2023137602A1 true WO2023137602A1 (fr) 2023-07-27

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PCT/CN2022/072622 WO2023137602A1 (fr) 2022-01-18 2022-01-18 Injecteur

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1249693A (zh) * 1997-02-28 2000-04-05 斯塔尔外科公司 青光眼排水器植入装置及方法
US20050125003A1 (en) * 2003-12-05 2005-06-09 Leonard Pinchuk Glaucoma implant device
US20110112546A1 (en) * 2009-07-29 2011-05-12 Juan Jr Eugene De Ocular implant applier and methods of use
CN111557782A (zh) * 2020-04-27 2020-08-21 中国科学院自动化研究所 一种用于青光眼粘小管成形术的柔性微导管递送机构
CN212214004U (zh) * 2020-05-14 2020-12-25 江苏百视通医疗器械有限公司 一种植入体的多次植入装置
CN213283754U (zh) * 2020-05-29 2021-05-28 孙启锋 经前房逆行巩膜固定青光眼全穿透引流钉
CN113397809A (zh) * 2021-06-11 2021-09-17 北京奥京生物科技有限公司 青光眼微创手术推注器

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1249693A (zh) * 1997-02-28 2000-04-05 斯塔尔外科公司 青光眼排水器植入装置及方法
US20050125003A1 (en) * 2003-12-05 2005-06-09 Leonard Pinchuk Glaucoma implant device
US20110112546A1 (en) * 2009-07-29 2011-05-12 Juan Jr Eugene De Ocular implant applier and methods of use
CN111557782A (zh) * 2020-04-27 2020-08-21 中国科学院自动化研究所 一种用于青光眼粘小管成形术的柔性微导管递送机构
CN212214004U (zh) * 2020-05-14 2020-12-25 江苏百视通医疗器械有限公司 一种植入体的多次植入装置
CN213283754U (zh) * 2020-05-29 2021-05-28 孙启锋 经前房逆行巩膜固定青光眼全穿透引流钉
CN113397809A (zh) * 2021-06-11 2021-09-17 北京奥京生物科技有限公司 青光眼微创手术推注器

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