WO2023135906A1 - 組織移植用樹脂製チップ、組織移植用デバイス、網膜組織移植方法及び網膜組織移植用キット - Google Patents

組織移植用樹脂製チップ、組織移植用デバイス、網膜組織移植方法及び網膜組織移植用キット Download PDF

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Publication number
WO2023135906A1
WO2023135906A1 PCT/JP2022/040856 JP2022040856W WO2023135906A1 WO 2023135906 A1 WO2023135906 A1 WO 2023135906A1 JP 2022040856 W JP2022040856 W JP 2022040856W WO 2023135906 A1 WO2023135906 A1 WO 2023135906A1
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WO
WIPO (PCT)
Prior art keywords
tissue
needle tube
tip
resin
less
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
Application number
PCT/JP2022/040856
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
道子 万代
康夫 栗本
篤 桑原
隆 中川
耕一郎 真鍋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Pharma Co Ltd
RIKEN
Original Assignee
Sumitomo Pharmaceuticals Co Ltd
Sumitomo Pharma Co Ltd
RIKEN
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 Sumitomo Pharmaceuticals Co Ltd, Sumitomo Pharma Co Ltd, RIKEN filed Critical Sumitomo Pharmaceuticals Co Ltd
Priority to US18/727,500 priority Critical patent/US20260000538A1/en
Priority to EP22920428.4A priority patent/EP4464290A4/en
Priority to CA3247979A priority patent/CA3247979A1/en
Priority to CN202280088613.8A priority patent/CN118541117A/zh
Priority to JP2023573858A priority patent/JPWO2023135906A1/ja
Publication of WO2023135906A1 publication Critical patent/WO2023135906A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/148—Implantation instruments specially adapted therefor
    • 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
    • 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
    • A61F9/00727—Apparatus for retinal reattachment

Definitions

  • the present invention relates to a resin chip for tissue transplantation used for transplanting tissue under the retina in the eyeball, a device for tissue transplantation provided with the same, a method for transplanting retinal tissue using the same, and a kit for retinal tissue transplantation.
  • the present invention relates to a resin chip for tissue transplantation, a device for tissue transplantation, a method for transplanting retinal tissue, and a kit for retinal tissue transplantation, which facilitates transplantation of tissue aspirated inside.
  • tissue-transplanting resin tip used for transplanting a tissue such as a retinal tissue under the retina in the eyeball
  • resin chips for tissue transplantation are used as follows. That is, after tissue is aspirated into the tissue-implantation resin tip, the tissue-implantation resin tip is inserted into the subretinal space of the patient's eyeball, and the retinal tissue is injected from the tip of the tissue-implantation resin tip into the subretinal space. The tissue is transplanted by ejecting the tissue into the lower space.
  • An object of the present invention is to provide a tissue-transplanting resin chip, a tissue-transplanting device, a retinal tissue-transplanting method, and a retinal tissue-transplanting kit that facilitates the transplantation of tissue aspirated inside.
  • the present inventors repeatedly made prototypes of resin tips for tissue transplantation and conducted intensive studies. , found that a resin chip for tissue transplantation can be obtained, which facilitates the transplantation of tissue sucked into the interior of the eyeball under the retina, and completed the present invention.
  • the present invention provides a resin chip used for implanting tissue under the retina in an eyeball, comprising a needle tube that can be inserted into the eyeball, wherein the needle tube is linear. and a tip portion that bends and extends linearly with respect to the main body portion and discharges the tissue from the tip, the length of the needle tube being 25 mm or more and 50 mm or less, and
  • the tip has an elliptical cross-sectional shape with a major axis of 0.8 mm or more and 1.5 mm or less and a minor axis of 0.5 mm or more and 1.0 mm or less; and a bevel surface with a bevel angle of 50° or more and 85° or less, the hardness of the tip portion is 0.15 N or more and 0.30 N or less, and the hardness of the center of the needle tube is , 0.80 N or more and 1.50 N or less.
  • tissue means a structure of a cell population having a structure in which one or more types of cells with different morphologies and properties are three-dimensionally arranged in a certain pattern.
  • length of the needle tube refers to the longitudinal direction of the main body between the tip of the needle tube (the tip of the tip of the needle tube) and the rear end of the needle tube (the rear end of the main body of the needle tube). It means the dimension in the direction parallel to the (extending direction) (the dimension in the direction parallel to the central axis of the main body of the needle tube).
  • the "front end” means the end on the side where the needle tube is first inserted into the eyeball, and the “rear end” means the end on the opposite side.
  • the “rear end” of the needle tube means the tip of the connecting part or the boundary between the needle tube and the connecting part.
  • the “cross-sectional shape of the distal end portion” means the cross-sectional shape of the distal end portion of the needle tube in a direction orthogonal to the longitudinal direction (extending direction).
  • a direction substantially orthogonal to the main body means a direction substantially orthogonal to the central axis of the main body of the needle tube.
  • the "direction substantially perpendicular to the body” is 80° or more (preferably 85° or more, 87° or more, 88° or more, or , 89° or more), 100° or less (preferably 95° or less, 93° or less, 92° or less, or 91° or less).
  • the "bevel angle” means an acute angle formed between the tip (bevel surface) of the tip of the needle tube and the outer surface of the tip of the needle tube adjacent to the tip.
  • “hardness” means the load required to displace the site to be measured for hardness by 5 mm while the rear end of the resin tip for tissue transplantation is fixed.
  • the distal end portion of the needle tube is bent with respect to the main body portion of the needle tube and extends linearly, and the tip of the distal end portion of the needle tube is bent relative to the main body portion of the needle tube. It extends in a substantially orthogonal direction and has a bevel angle of 50° or more and 85° or less (for example, about 60°), preferably 60° or more and 85° or less (for example, about 75° (75° ⁇ 3°, 75°). ⁇ 2°, 75° ⁇ 1°)) beveled surface.
  • the hardness of the distal end portion of the needle tube is 0.15 N or more and 0.30 N or less
  • the hardness of the center (the center in the longitudinal direction) of the needle tube is 0.15 N or more and 0.30 N or less. It is 80N or more and 1.50N or less. Therefore, it is possible to prevent the needle tube from shaking in the eyeball.
  • a person skilled in the art can manufacture a resin tip for tissue transplantation having a center and a distal end of a needle tube with different hardnesses.
  • the thickness and cross-sectional shape of the resin to decrease toward the distal end portion, it is possible to manufacture a tissue-implantation resin tip having different hardness depending on the site, as described above.
  • the resin tip for tissue transplantation according to the present invention has the characteristics of the bevel angle and hardness described above, and the length of the needle tube and the shape of the cross-sectional outline of the distal end of the needle tube are defined within the predetermined ranges described above.
  • the tissue sucked into the needle can be easily and reliably implanted under the desired subretinal region.
  • the hardness of the tip portion is 0.20N or more and 0.30N or less.
  • the tip has a length of 2 mm or more and less than 6 mm.
  • the "length of the distal end portion” is the dimension in the direction parallel to the longitudinal direction (extending direction) of the distal end portion between the distal end of the distal end portion of the needle tube and the rear end of the distal end portion of the needle tube. (dimension in the direction parallel to the central axis of the tip of the needle tube). According to the preferred configuration described above, the tissue sucked into the needle can be more easily and reliably implanted under the desired subretinal region.
  • the tip is bent at an angle of 120° or more and 160° or less with respect to the main body. More preferably, the tip is bent at an angle of 120° or more (more preferably 130° or more) and 150° or less with respect to the main body.
  • the central outer diameter of the needle tube is 1.5 mm or more and 3.5 mm or less.
  • the needle tube has transparency such that the tissue moving inside the needle tube can be visually recognized from the outside.
  • the position of the tissue inside the needle can be visually recognized from the outside, so the tissue can be transplanted more easily.
  • the resin chip for tissue transplantation includes, for example, polyolefin resins (polypropylene, polyethylene, polymethylpentene), cycloolefin resins [cycloolefin polymer (COP), cycloolefin copolymer (COC)], and polyester resins.
  • polyolefin resins polypropylene, polyethylene, polymethylpentene
  • cycloolefin resins [cycloolefin polymer (COP), cycloolefin copolymer (COC)]
  • polyester resins for example, polyolefin resins (polypropylene, polyethylene, polymethylpentene), cycloolefin resins [cycloolefin polymer (COP), cycloolefin copolymer (COC)]
  • polyethylene terephthalate fluororesin [polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), perfluoroethylene propene copolymer (FEP), ethylenetetrafluoroethylene copolymer (ETFE), polyvinylidene fluoride (PVDF) , polychlorotrifluoroethylene (PCTFE), or ethylene chlorotrifluoroethylene copolymer (ECTFE)], polycarbonate and polyimide.
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxyalkane
  • FEP perfluoroethylene propene copolymer
  • ETFE ethylenetetrafluoroethylene copolymer
  • PVDF polyvinylidene fluoride
  • PCTFE polychlorotrifluoroethylene
  • ECTFE ethylene chlorotrifluoroethylene copolymer
  • the resin tip for tissue transplantation includes a stopper in the main body for preventing movement of the tissue toward the rear end side of the needle tube.
  • a stopper can freely design the position of the stopper in the main body (the position where the internal space of the main body is narrowed), the shape of the stopper, and the length of the stopper.
  • a stopper can be provided at a position 10 mm to 30 mm from the tip of the needle tube.
  • a tubular member made of resin or stainless steel which is inserted into the main body of the needle tube or integrally molded with the main body, can be used.
  • the tissue does not move to the rear end side of the position where the stopper is provided, so the tissue is not excessively sucked into the needle tube, and the tissue can be transplanted more reliably.
  • said tissue is retinal tissue.
  • the "retinal tissue” refers to photoreceptor cells, horizontal cells, bipolar cells, amacrine cells, retinal ganglion cells, retinal pigment epithelial cells, their progenitor cells, or retina that constitute each retinal layer in the living retina. It means a tissue in which one type or multiple types of retinal cells such as progenitor cells are layered and three-dimensionally arranged. In one aspect, one or more of the retinal cells described above may form a single layer or multiple layers in a given pattern.
  • the layers that can be included in the retinal tissue are the retinal pigment epithelial layer, the outer limiting membrane, the photoreceptor layer (outer nuclear layer), the outer reticular layer, the inner nuclear layer, the inner reticular layer, the ganglion cell layer, the nerve fiber layer and the inner boundary. Also called membrane.
  • Retinal tissue even retinal tissue excised from a living body (e.g., fetus), was induced to differentiate from autologous or allogeneic pluripotent stem cells (e.g., embryonic stem cells (ES cells), induced pluripotent stem cells (iPS cells)). It may be retinal tissue.
  • the retinal tissue may be retinal tissue, including the neural retina (including photoreceptors). Methods for preparing retinal tissue from living organisms are well known to those skilled in the art. Specifically, retinal tissue can be excised under anesthesia.
  • Methods for inducing differentiation from pluripotent stem cells to retinal tissue include WO2011/055855, WO2013/077425, WO2015/025967, WO2016/063985, WO2016/063986, WO2017/183732, and "PLoS One. 2010 Jan 2 0; 5 (1):e8763.”, "Stem Cells. 2011 Aug;29(8):1206-18.”, "Proc Natl Acad Sci USA.
  • the size of the tissue is not particularly limited as long as it can move inside the needle tube.
  • the tissue having a minor axis of 400 ⁇ m or more and 800 ⁇ m or less and a thickness of 400 ⁇ m or more and 600 ⁇ m or less be movable inside the needle tube.
  • a retinal tissue of the above size can be prepared by cutting out the retinal tissue prepared by the method described above.
  • the resin tip for tissue transplantation according to the present invention can aspirate and eject tissue by connecting it to, for example, a syringe, but it is not limited to this.
  • an injection syringe and a tissue-implantation resin tip according to the present invention are connected, and the injection syringe is pulled to aspirate tissue into the needle tube of the tissue-implantation resin tip.
  • the tissue is discharged from the inside of the needle tube of the resin chip for tissue transplantation.
  • tissue may be ejected using an injection kit to which a cataract/vitreous surgery apparatus is connected. Specifically, the tissue-transplanting resin tip with tissue aspirated inside the needle tube is removed from the injection syringe and connected to the injection kit.
  • the injection kit is operated by the cataract/vitreous surgery apparatus, and the tissue is ejected from the inside of the needle tube into the subretinal space. do.
  • the syringe of the injection kit connected to the cataract/vitreous surgery device and the resin tip for tissue transplantation according to the present invention may be directly connected. Since a cataract/vitreous surgery apparatus usually has an aspiration function, the aspiration function is activated to aspirate the tissue into the needle tube of the resin tip for tissue transplantation. After that, the tissue is discharged from the inside of the needle tube into the subretinal space by the same method as described above.
  • the present invention includes a stopcock, the tissue transplantation resin chip connected to one port of the stopcock, and a syringe connected to the other port of the stopcock. , is also provided as a device for tissue implantation.
  • the resin tip and syringe for tissue transplantation should not be connected directly to each port of the stopcock, but should be connected to a tube (e.g., EAGLE LABS "Ocular Irrigation Tube” REF# 169-30L-6). You may connect to each port via a tube (e.g., EAGLE LABS "Ocular Irrigation Tube" REF# 169-30L-6). You may connect to each port via a tube (e.g., EAGLE LABS "Ocular Irrigation Tube" REF# 169-30L-6). You may connect to each port via
  • a three-way stopcock or a two-way stopcock can be used as the "stopcock".
  • the device for tissue transplantation for example, when a three-way stopcock is provided as the stopcock, it can be used as follows. That is, a tissue-transplanting resin tip is connected to one port of the three-way stopcock, and a syringe is connected to the other port. Then, by turning on (opening) the port connected to the tissue-implantation resin tip and the port to which the syringe is connected, and pulling the syringe, the tissue is aspirated into the needle tube of the tissue-implantation resin tip.
  • an injection kit for example, is connected to the remaining ports of the three-way stopcock, a cataract/vitreous surgery device is connected to the injection kit, and the port to which the resin chip for tissue transplantation is connected and the injection kit are connected. turn on (open) the port
  • the injection kit is operated by the cataract/vitreous surgery apparatus to insert the tissue from the inside of the needle tube into the subretinal space. Dispense. Tissue can be transplanted by the above operation.
  • the tissue grafting resin tip, syringe and injection kit may be directly connected to each port of the three-way stopcock, or may be connected to a tube (for example, EAGLE LAB "Ocular Irrigation Tube”REF# 169- 30L-6).
  • a tube for example, EAGLE LAB "Ocular Irrigation Tube”REF# 169- 30L-6.
  • a tissue-transplanting resin tip is connected to one port of the two-way stopcock, and a syringe is connected to the other port.
  • the tissue is aspirated into the needle tube of the tissue-implantation resin tip by turning on (opening) the port to which the tissue-implantation resin tip is connected and the port to which the syringe is connected, and pulling the syringe.
  • the port to which the syringe is connected is turned off (occluded), and after removing the syringe, for example, an injection kit is connected to this port, a cataract/vitreous surgery device is connected to the injection kit, and this port is on (open).
  • the injection kit is operated by the cataract/vitreous surgery apparatus to insert the tissue from the inside of the needle tube into the subretinal space. Dispense. Tissue can be transplanted by the above operation.
  • the tissue grafting resin tip, syringe and injection kit may be directly connected to each port of the two-way stopcock, or may be connected to a tube (e.g., EAGLE LAB "Ocular Irrigation Tube”REF# 169). -30L-6) may be connected.
  • the present invention provides a method for subretinal transplantation of retinal tissue into the eyeball of a patient suffering from a disease based on injury or damage to retinal tissue, wherein the tissue transplantation device is and pulling the syringe to aspirate the retinal tissue into the needle tube of the resin tip for tissue transplantation;
  • a method for transplanting retinal tissue is also provided, comprising the steps of inserting and ejecting the retinal tissue from the inside of the needle tube into the subretinal space.
  • Diseases based on retinal tissue disorders include, for example, retinal degenerative diseases, macular degeneration, age-related macular degeneration, retinitis pigmentosa, glaucoma, corneal diseases, retinal detachment, central serous chorioretinopathy, cone dystrophy, cone ophthalmic diseases such as rod-and-rod dystrophy.
  • Diseases based on damage to retinal tissue include, for example, degeneration, atrophy, and cell death of photoreceptor cells, retinal pigment epithelial cells, and the like.
  • the present invention also provides a retinal tissue transplantation kit comprising a retinal tissue and the resin chip for tissue transplantation.
  • the kit for retinal tissue transplantation according to the present invention includes at least one or more of a syringe, an injection kit and a tube (for example, EAGLE LAB "Ocular Irrigation Tube”REF# 169-30L-6). You may also prepare.
  • a resin chip used for implanting tissue under the retina in the eyeball comprising a needle tube that can be inserted into the eyeball, the needle tube having a linearly extending body portion and a a distal end portion that extends linearly by bending against the distal end portion and discharges the tissue from the distal end portion, the needle tube has a length of 25 mm or more and 50 mm or less, and the cross-sectional shape of the distal end portion has a major axis of 0.
  • the tip of the tip extends in a direction substantially perpendicular to the main body and has a bevel angle. is a bevel surface of 50° or more and 85° or less, the hardness of the tip portion is 0.15N or more and 0.30N or less, and the hardness of the center of the needle tube is 0.80N or more and 1.50N or less.
  • a resin chip for tissue transplantation [2] The resin tip for tissue transplantation according to [1], wherein the tip has a hardness of 0.20N or more and 0.30N or less.
  • the tissue is retinal tissue, and the retinal tissue having a minor axis of 400 ⁇ m or more and 800 ⁇ m or less and a thickness of 400 ⁇ m or more and 600 ⁇ m or less is movable inside the needle tube, [1] to [8].
  • a method of subretinal transplantation of retinal tissue in the eyeball of a patient suffering from a disease based on injury or damage to retinal tissue wherein the tissue transplantation device of [10] is used, and the syringe is a step of aspirating the retinal tissue into the inside of the needle tube of the resin tip for tissue transplantation by pulling; a step of inserting the needle tube from which the retinal tissue has been aspirated into the subretinal space in the eyeball of the patient; and discharging the retinal tissue from the inside of the needle tube into the subretinal space.
  • a retinal tissue transplantation kit comprising a retinal tissue and the resin chip for tissue transplantation according to any one of [1] to [8].
  • tissue-transplanting resin chip a tissue-transplanting device, a retinal tissue-transplanting method, and a retinal tissue-transplanting kit that facilitates the transplantation of tissue aspirated inside.
  • FIG. 1 is a view showing a schematic configuration of a resin chip for tissue transplantation according to one embodiment of the present invention; It is a figure explaining the method of measuring the hardness of the needle tube shown in FIG.
  • FIG. 2 is a perspective view schematically showing an example of a schematic configuration of tissue to be transplanted by the chip shown in FIG. 1; 2 is a diagram showing a schematic configuration of a modified example of the chip shown in FIG. 1;
  • FIG. 1 is a plan view showing a schematic configuration of a tissue transplantation device according to one embodiment of the present invention;
  • FIG. FIG. 6 shows an example of a tissue transplantation method using the device shown in FIG. 5; It is a figure explaining the content of the evaluation test using each chip
  • 1 is a side view showing a schematic configuration of a chip described in Non-Patent Document 1; FIG.
  • FIG. 1 is a diagram showing a schematic configuration of a resin chip for tissue transplantation (hereinafter abbreviated as “chip” as appropriate) according to one embodiment of the present invention.
  • FIG. 1(a) is a plan view showing the schematic configuration of the tip according to the present embodiment (a view along a plane passing through the main body and the distal end of the needle tube provided in the tip).
  • FIG. 1(b) is a side view (viewed from a direction orthogonal to a plane passing through the main body and the distal end of the needle tube provided in the tip) showing the schematic configuration of the tip according to the present embodiment.
  • FIG. 1(c) is a side view showing an enlarged schematic configuration near the tip of the tip according to the present embodiment.
  • FIG.1(d) is AA arrow directional cross-sectional view shown in FIG.1(c).
  • a chip 10 according to the present embodiment shown in FIG. 1 is a resin chip used for implanting tissue under the retina in the eyeball.
  • the chip 10 according to the present embodiment is preferably used for subretinal transplantation of retinal tissue into the eyeball of a patient suffering from a disease based on injury or damage to the retinal tissue.
  • the tip 10 has a needle tube 1 that can be inserted into the eyeball.
  • the tip 10 according to the present embodiment includes a hollow connecting portion 2 connected to the rear end of the needle tube 1 and communicating with the needle tube 1, and a blade portion 3 provided on the outer surface of the connecting portion 2.
  • the "front end” means the end on the side where the needle tube 1 is first inserted into the eyeball (left side in FIGS. 1(a) to 1(c)), and the "rear end” means the opposite side (FIG. 1(a) to the right side of (c)).
  • the vanes 3 function to ensure the connection of the chip 10 to the port 20a of the stopcock 20, which will be described later.
  • the wing portion 3 can also be used as a mark of the rear end of the needle tube 1 when the needle tube 1 is inserted into the eyeball.
  • the needle tube 1 includes a linearly extending main body portion 11 and a distal end portion 12 that is bent relative to the main body portion 11 and linearly extended to discharge tissue from a distal end portion 121 .
  • the body portion 11 of the needle tube 1 of the present embodiment has a circular cross-sectional shape, and has a tapered shape in which the outer diameter of the cross section decreases toward the distal end portion 12 side. Since the body portion 11 has a tapered outer diameter, the hardness of the rear end of the needle tube 1 is increased, and the shaking of the needle tube 1 in the eyeball can be effectively prevented.
  • the length L1 of the needle tube 1 is 25 mm or more and 50 mm or less.
  • the length L1 of the needle tube 1 is between the tip 121 of the needle tube 1 (the tip 121 of the tip portion 12 of the needle tube 1) and the rear end 111 of the needle tube 1 (the rear end 111 of the main body portion 11 of the needle tube 1).
  • , means the dimension in the direction parallel to the longitudinal direction (extending direction) of the body portion 11 (the dimension in the direction parallel to the central axis CL1 of the body portion 11 of the needle tube 1).
  • the rear end 111 of the needle tube 1 coincides with the tip of the blade portion 3 .
  • the cross-sectional outline of the distal end portion 12 of the needle tube 1 (the cross-sectional outline in the direction orthogonal to the longitudinal direction (extending direction) of the distal end portion 12 of the needle tube 1) is the side surface side of the distal end portion 12 (the body portion 11 and the distal end portion 12 of the needle tube 1). (viewed from the direction orthogonal to the plane passing through the )) is an elliptical shape with a major axis D1 of 0.8 mm or more and 1.5 mm or less, and a minor axis D2 of 0.5 mm or more and 1.0 mm or less. be.
  • a tip 121 of the distal end portion 12 of the needle tube 1 extends in a direction substantially orthogonal to the body portion 11 and is a beveled surface having a bevel angle ⁇ 1 of 50° or more and 85° or less.
  • the direction substantially orthogonal to the body portion 11 means the direction substantially orthogonal to the central axis CL ⁇ b>1 of the body portion 11 of the needle tube 1 .
  • the “bevel angle ⁇ 1” means an acute angle between the tip 121 (bevel surface) of the tip 12 of the needle tube 1 and the outer surface 122 of the tip 12 of the needle tube 1 adjacent to the tip 121 .
  • the distal end portion 12 of the needle tube 1 is bent with respect to the main body portion 11 of the needle tube 1 and extends linearly, and the distal end portion 121 of the distal end portion 12 of the needle tube 1 extends in a direction substantially orthogonal to the main body portion 11 of the needle tube 1. Since the bevel surface extends and the bevel angle ⁇ 1 is 50° or more and 85° or less, the tip part 12 of the needle tube 1 can be easily lifted by inserting the tip part 12 of the needle tube 1 into the subretinal space in the eyeball of the patient, and the tip of the needle tube 1 can be easily lifted. The tissue can be easily discharged from the tip 121 of the portion 12 .
  • the hardness of the distal end portion 12 of the needle tube 1 is 0.15 N or more and 0.30 N or less (preferably 0.20 N or more and 0.30 N or less), the center of the needle tube 1 (the center in the longitudinal direction of the needle tube 1,
  • the hardness of the portion having the outer diameter D3 in FIG. 1(a) located at a distance of 1/2 of the length L1 from the tip 121 of the needle tube 1 is 0.80N or more and 1.50N or less.
  • “hardness” means the load required to displace the part (the tip 12 of the needle tube 1, the center of the needle tube 1) whose hardness is to be measured with the rear end of the tip 10 fixed, by 5 mm.
  • the hardness of the distal end portion 12 of the needle tube 1 and the hardness of the central portion within the above ranges, it is possible to prevent the needle tube 1 from shaking in the eyeball.
  • the hardness of each portion of the needle tube 1 can be adjusted by appropriately setting the forming material, thickness, and the like of the needle tube 1 .
  • FIG. 2 is a diagram explaining a method of measuring the hardness of the needle tube 1.
  • FIG. FIG. 2 illustrates the case of measuring the hardness of the distal end portion 12 of the needle tube 1 .
  • a flat support base 50 when measuring the hardness of the needle tube 1, a flat support base 50, a small vise (mini vise) 60, a syringe (for example, a 0.5 mL syringe manufactured by Bethel) 70, a force gauge (for example , Imada digital force gauge "DVS-5N”) 80 and a V-shaped attachment 81 attached to the force gauge 80 are used.
  • the small vise 60 is fixed to the support base 50 and the syringe 70 is attached to the small vise 60 .
  • the tip 10 is attached to the luer portion (not shown) of the syringe 70 so that the tip portion 12 faces downward.
  • the V-shaped attachment 81 is brought into contact with the tip portion 12 (specifically, the rear end of the tip portion 12) from above, and the force gauge 80 and the V-shaped attachment are brought into contact with each other.
  • the load (peak load) measured by the force gauge 80 in this state is taken as the hardness of the tip 12 of the needle tube 1. .
  • the V-shaped attachment 81 When measuring the hardness of the center of the needle tube 1, the V-shaped attachment 81 is brought into contact with the center of the needle tube 1 from above, and the force gauge 80 and the V-shaped attachment 81 are displaced downward by 5 mm (thus, the needle tube 1 The center of the needle tube 1 is also displaced downward by 5 mm), and the load (peak load) measured by the force gauge 80 in this state is taken as the hardness of the center of the needle tube 1 .
  • the tip 10 has the characteristics of the bevel angle ⁇ 1 and the hardness described above, and in addition, the length L1 of the needle tube 1 and the shape of the cross-sectional outline of the distal end portion 12 of the needle tube 1 are within the above-described predetermined range. By being defined, the tissue sucked into the needle tube 1 can be easily and reliably implanted under the desired subretinal region.
  • the length L2 of the distal end portion 12 of the needle tube 1 is 2 mm or more and less than 6 mm (less than 4 mm as one aspect).
  • the length L2 of the distal end portion 12 of the needle tube 1 is the length of the distal end portion 12 between the distal end 121 of the distal end portion 12 of the needle tube 1 and the rear end of the distal end portion 12 of the needle tube 1 (the distal end of the main body portion 11). means the dimension in the direction parallel to the longitudinal direction (extending direction) of (the dimension in the direction parallel to the central axis CL2 of the distal end portion 12 of the needle tube 1).
  • the distal end portion 12 of the needle tube 1 is bent to form an angle (bend angle) ⁇ 2 of 120° or more and 160° or less with respect to the body portion 11 of the needle tube 1 .
  • the central outer diameter of the needle tube 1 is 1.5 mm or more and 3.5 mm or less.
  • the needle tube 1 has transparency that allows the tissue moving inside the needle tube 1 to be visible from the outside.
  • the transparency of the needle tube 1 can be adjusted by appropriately setting the forming material, thickness, and the like of the needle tube 1 .
  • the tip 10 (needle tube 1, connecting portion 2 and vane portion 3) according to the present embodiment is made of polyolefin resin (polypropylene, polyethylene, polymethylpentene), cycloolefin resin [cycloolefin polymer (COP), cycloolefin copolymer ( COC)], polyester resin (polyethylene terephthalate), fluorine resin [polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), perfluoroethylene propene copolymer (FEP), ethylenetetrafluoroethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), or ethylene chlorotrifluoroethylene copolymer (ECTFE)], polycarbonate and polyimide.
  • the needle tube 1, the connecting portion 2, and the blade portion 3 may be integrally molded using the above-described resin using a mold, or may be individually
  • FIG. 3 is a perspective view schematically showing an example of a schematic configuration of tissue to be transplanted by the chip 10 according to this embodiment.
  • the tissue T shown in FIG. 3 is a retinal tissue, and has a minor axis D4 of 400 ⁇ m or more and 800 ⁇ m or less and a thickness H of 400 ⁇ m or more and 600 ⁇ m or less.
  • the length D5 is approximately 1200 ⁇ m.
  • the tip 10 according to this embodiment has a major axis D5 of the tissue T along the longitudinal direction of the needle tube 1, a minor axis D4 of the tissue T along the major axis D1 direction of the distal end portion 12 of the needle tube 1, and a thickness H of the tissue T along the needle tube.
  • the tissue T is configured to be movable inside the needle tube 1 along the minor axis D2 direction of the distal end portion 12 of 1 (the inner diameter of the needle tube 1 is set to a dimension that does not hinder the movement of the tissue T). ).
  • the tissue T moves through the distal end portion 12 of the needle tube 1, the minor axis D4 and thickness H of the tissue T may be reversibly deformed (contracted).
  • FIG. 4 is a diagram showing a schematic configuration of a modified example of the chip 10 according to this embodiment.
  • FIG. 4(a) is a side view (viewed from a direction orthogonal to a plane passing through the main body portion 11 and the distal end portion 12 of the needle tube 1 included in the tip 10A) showing the schematic configuration of the tip 10A according to the modification.
  • FIG. 4(b) is an enlarged cross-sectional view taken along line BB shown in FIG. 4(a).
  • the stopper 4 functions to prevent the tissue T from moving toward the rear end of the needle tube 1 .
  • a blunt needle For example, a 25G non-bevel needle
  • the tissue T does not move to the rear end side of the position where the stopper 4 is provided (does not move to the right side of the BB line shown in FIG. 4A).
  • the tissue T can be transplanted more reliably without excessive suction of the tissue T inside.
  • FIG. 4 exemplifies a configuration using a blunt needle inserted into the needle tube 1 as the stopper 4, the present invention is not limited to this, and the function of preventing the tissue T from moving toward the rear end side of the needle tube 1 is provided.
  • the needle tube 1 itself may be provided with a diameter-reduced portion, and this diameter-reduced portion may function as the stopper 4 .
  • FIG. 5 is a plan view showing a schematic configuration of a tissue transplantation device according to one embodiment of the present invention.
  • the tissue transplantation device 100 includes a stopcock 20, a chip 10 according to this embodiment connected to one port of the stopcock 20, and connected to another port of the stopcock 20. and a syringe (for example, a 1 ml syringe or a 0.5 ml syringe) 30.
  • a syringe for example, a 1 ml syringe or a 0.5 ml syringe
  • at least the tissue T and the chip 10 constitute a retinal tissue transplantation kit.
  • the retinal tissue transplantation kit may further include at least one or more of a syringe 30, an injection kit and a tube, which will be described later.
  • the tissue transplantation device 100 includes a three-way stopcock having three ports 20a, 20b and 20c as the stopcock 20. As shown in FIG. However, the present invention is not limited to this, and it is also possible to employ a configuration including a two-way stopcock as the stopcock 20 . In the example shown in FIG. 5, tip 10 is connected to port 20a via lock adapter 40, and syringe 30 is connected to port 20b.
  • tissue T tissue T (retinal tissue) using the tissue transplantation device 100
  • a general vitreous stalk microscopic transection is performed using a cataract/vitreous surgery device (eg, Constellation Vision System manufactured by Alcon).
  • a cataract/vitreous surgery device eg, Constellation Vision System manufactured by Alcon.
  • an injection kit e.g., Medwan Injection Kit
  • the injection kit is filled with a balanced salt solution
  • a cannula e.g., Medwan Cannula, certification number 226AFBZI00075000
  • the balanced salt solution filled in the injection kit is injected into the subretinal space through the cannula to produce localized retinal detachment. Then, the site of the detached retina is partially incised with vitreous scissors or the like to form a graft wound.
  • the port 20b to which the syringe 30 is connected is turned off (closed), and the syringe 30 is removed from the port 20b.
  • the port 20b to which the syringe 30 is connected and the remaining port 20c are required. are both turned off (closed) to remove syringe 30 from port 20b.
  • the remaining port 20c of the stopcock 20 is connected to an injection kit (for example, Med One Injection Kit), and the injection kit is connected to the injection kit as described above.
  • the cataract/vitreous surgery apparatus is connected, and the port 20a to which the chip 10 is connected and the port 20c to which the injection kit is connected are turned on (opened).
  • the injection kit to the port 20c it is preferable to fill the dead space of the port 20c with an eye irrigating solution for ophthalmic surgery.
  • the needle tube 1 of the tip 10 is inserted into the eyeball E through an incision made in the sclera E1 of the patient's eyeball E, and the tip portion 12 is prepared in the retina R as described above. Reach the use wound R1.
  • the injection kit is operated using the liquid injection function of the cataract/vitreous surgery apparatus, so that the injection kit is operated from the inside of the needle tube 1 to the subretinal space.
  • a tissue T is ejected into the space.
  • the position of the tissue T after ejection may be adjusted using subretinal forceps or the like, if necessary.
  • FIG. 7 is a diagram for explaining the content of the evaluation test.
  • FIG. 7A is a diagram showing conditions and evaluation results of each chip.
  • FIG. 7(b) is a diagram for explaining the meaning of the tip of the tip portion being an "upward bevel surface”.
  • FIG. 8 is a side view (viewed from a direction orthogonal to a plane passing through the main body and the distal end of the needle tube provided in the tip) showing the schematic configuration of the tip described in Non-Patent Document 1.
  • FIG. "Comparative Example” shown in FIG. 7A is the conditions and evaluation results of the chip described in Non-Patent Document 1
  • “Reference Example 1” to “Reference Example 4" are the conditions and evaluation results of the prototype chips.
  • “Example 1” to “Example 5” are conditions and evaluation results of the chip 10 according to the present embodiment.
  • the tip 10B according to the comparative example includes a needle tube 1 (body portion 11 and tip portion 12) and a connection portion 2, like the tip 10 according to the present embodiment.
  • the stopper 4 is provided in the same manner as the chip 10A according to the above-described modified example.
  • the tip 10B according to the comparative example does not have the blade portion 3 .
  • the tip 121 of the tip 12 of the tip 10B according to the comparative example is not a beveled surface but a surface extending in a direction orthogonal to the longitudinal direction (extending direction) of the tip 12 .
  • the bevel angle of the comparative example is described as 90°. means extending in the direction The same applies to Reference Example 1 shown in FIG. 7(a).
  • the tip 121 of the tip portion 12 is a bevel surface extending in a direction substantially orthogonal to the body portion 11 .
  • the numerical values in the hatched columns mean that the conditions required for the resin chip for tissue transplantation according to the present invention are not satisfied.
  • ⁇ described in the "transplantation evaluation” column shown in Fig. 7(a) means that transplantation of the tissue T into the subretinal region was somewhat difficult.
  • O means that the tissue T was generally well transplanted under the retina.
  • A means that the tissue T was successfully transplanted under the retina without any problems.
  • ⁇ means that the transplantation of the tissue T into the subretinal region was the best without any problems.
  • Comparative Example Reference Examples 1 to 4, Example 1, and Example 2, a resin chip for tissue transplantation was used to evaluate the transplantation of tissue T into the subretinal region of monkeys. .
  • Example 3 to 5 a resin chip for tissue transplantation was used to evaluate the transplantation of the tissue T under the retina of an excised porcine eye.
  • the transplantation of the tissue T into the subretinal region was generally good, or was good without any problem.
  • the use of the resin chips for tissue transplantation of Examples 2 to 5 was particularly successful in transplanting the tissue T into the subretinal region of large animals. That is, according to the resin tip for tissue transplantation according to the present invention, it was confirmed that the aspirated tissue T can be easily transplanted.

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  • Health & Medical Sciences (AREA)
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  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)
PCT/JP2022/040856 2022-01-12 2022-11-01 組織移植用樹脂製チップ、組織移植用デバイス、網膜組織移植方法及び網膜組織移植用キット Ceased WO2023135906A1 (ja)

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US18/727,500 US20260000538A1 (en) 2022-01-12 2022-11-01 Tissue transplantation resin tip, tissue transplantation device, retina tissue transplantation method, and retina tissue transplantation kit
EP22920428.4A EP4464290A4 (en) 2022-01-12 2022-11-01 Resin chip for tissue implantation, tissue implantation device, retinal tissue implantation procedure and retinal tissue implantation kit
CA3247979A CA3247979A1 (en) 2022-01-12 2022-11-01 Tissue transplant resin tip, tissue transplant device, retinal tissue transplant procedure, and retinal tissue transplant kit
CN202280088613.8A CN118541117A (zh) 2022-01-12 2022-11-01 组织移植用树脂制移植头、组织移植用器件、视网膜组织移植方法和视网膜组织移植用套件
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EP4464290A4 (en) 2025-12-17
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