CN115337139A

CN115337139A - Eye puncture device and eye implantation instrument assembly

Info

Publication number: CN115337139A
Application number: CN202110522811.8A
Authority: CN
Inventors: 赵潺; 夏超然; 孙月广; 李川
Original assignee: Beijing Huashi Novi Medical Technology Co ltd; Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Current assignee: Beijing Huashi Novi Medical Technology Co ltd; Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Priority date: 2021-05-13
Filing date: 2021-05-13
Publication date: 2022-11-15

Abstract

The invention discloses an eye puncture device and an eye implanting appliance assembly, the device comprises a needle cylinder, an elastic pushing component, a hollow puncture needle, at least one injection accommodating area and an eye injection, the elastic pushing component comprises a pressing part and a movable sealing part which is positioned in an inner cavity of the needle cylinder and can be punctured in front and back elastic connection with the pressing part, the hollow puncture needle is fixedly connected with the pressing part and is provided with a front end needle hole and a peripheral wall needle hole, the injection accommodating area is formed in an inner cavity area of the needle cylinder which is defined by the front closed end of the needle cylinder, the peripheral wall of the inner cavity of the needle cylinder and the movable sealing part together, and the eye injection is stored in the injection accommodating area in advance; according to the splenium through pressing down, can push the cavity pjncture needle forward to puncturing cylinder front closed end for the eye injection can be followed and held district, perisporium pinhole and the outside outflow of front end pinhole through the injection that has communicate in proper order, and this process is accurate to puncture degree of depth and control, and stability is high, and is favorable to realizing the ration and annotates the liquid.

Description

Eye puncture device and eye implantation instrument assembly

Technical Field

The invention relates to the technical field of medical appliances, in particular to an eye puncturing device and an eye implanting appliance assembly.

Background

In response to ocular diseases (e.g., glaucoma, suprachoroidal or subconjunctival diseases, etc.), some existing treatments involve injection, access, dilation, or implantation of devices into the visible or underlying interstitial spaces, the vasculature, or vessels of the eye using a syringe. However, the conventional injector needs to control the puncture depth manually during puncture, and depends on the experience of medical staff to judge whether the needle head punctures the target region in the eye, and the eye structures of different patients usually have differences, and the proficiency of different medical staff is different, so that the puncture accuracy cannot be effectively ensured. In addition, during the injection process, pressure capable of pushing the push rod of the injector needs to be continuously applied, and the process usually cannot ensure the stable injection speed.

Disclosure of Invention

In view of the above-mentioned drawbacks and deficiencies of the prior art, the present invention provides an eye puncturing device and an eye implanting apparatus assembly, which can realize injection, probing, expansion or instrument implantation of visible or potential tissue gaps, cavities and vessels of an eye, and has accurate control and high stability of puncturing depth and injection amount.

In order to achieve the above object, a first aspect of the present invention provides an eye puncturing device, which includes a needle cylinder, an elastic pushing assembly, a hollow puncturing needle, at least one injection accommodating area, and an eye injection suitable for eye injection, wherein the needle cylinder includes a front closed end and a rear open end, the elastic pushing assembly includes a pressing portion and a pierceable movable sealing portion located in an inner cavity of the needle cylinder and capable of forming front and rear elastic connection with the pressing portion, the hollow puncturing needle is fixedly connected to the pressing portion and formed with a front needle hole and a peripheral wall needle hole, the injection accommodating area is formed in an inner cavity area of the needle cylinder surrounded by the front closed end of the needle cylinder, the peripheral wall of the inner cavity of the needle cylinder, and the movable sealing portion, and the eye injection is stored in the injection accommodating area in advance;

the eye puncture device is arranged to push the hollow puncture needle forwards to puncture the front closed end of the needle cylinder by pressing the pressing part, so that the eye injection can flow out from the injection accommodating area, the peripheral wall needle hole and the front end needle hole which are communicated in sequence.

Optionally, the ocular injection comprises an ocular therapeutic agent for treating an ocular disease; and/or, the ocular injection comprises a settable ocular injection capable of setting after injection and dilation of the apparent or underlying interstitial space, the luminal system, the vasculature of the eye.

Optionally, the hollow puncture needle has a gauge of 30G to 23G.

Optionally, the eye piercing device comprises a first type of eye implant pre-mounted in the needle lumen of the hollow piercing needle and advanceable to release from the leading needle aperture;

and/or the eye puncture device comprises a second type of eye implant which is sleeved outside the hollow puncture needle and can move forwards to be released from the front end of the hollow puncture needle;

and/or, the eye piercing device includes a third type of eye implant releasably attached to the leading end of the hollow piercing needle.

Optionally, the first type of ocular implant, the second type of ocular implant, and the third type of ocular implant each comprise a drainage device suitable for glaucoma drainage therapy.

Optionally, the eye puncturing device comprises a sclera puncturing state after the hollow puncture needle punctures the front closed end of the needle cylinder, in the sclera puncturing state, the length range of the hollow puncture needle extending out of the front closed end of the needle cylinder is a sclera puncturing length range, and in the sclera puncturing length range, the peripheral wall needle hole is at least partially communicated with the injection accommodating area.

Optionally, the eye puncture device comprises a suprachoroidal flow guiding state after the hollow puncture needle punctures the front closed end of the needle cylinder, in the suprachoroidal flow guiding state, a length range of the hollow puncture needle protruding from the front closed end of the needle cylinder is a suprachoroidal flow guiding length range, and in the suprachoroidal flow guiding length range, the peripheral wall needle hole is located in the injection containing area.

Optionally, the eye puncture device includes a conjunctiva inferior cavity diversion state after the hollow puncture needle punctures the front closed end of the syringe, under the conjunctiva inferior cavity diversion state, the length range that the hollow puncture needle stretches out from the front closed end of the syringe is a conjunctiva inferior cavity diversion length range, in the conjunctiva inferior cavity diversion length range, the perisporium pinhole is located in the injection accommodation area.

Optionally, said peripheral wall needle aperture is maintained above said injection agent containment region until said hollow spike protrudes from said forward closed end of said barrel.

Optionally, the eye puncturing device comprises a flow guiding state which enables the injection accommodating area, the peripheral wall needle hole and the front end needle hole to be communicated, and in the flow guiding state, the movable sealing part can move forwards to block the peripheral wall needle hole under the action of resilience force between the movable sealing part and the pressing part.

Optionally, in the diversion state, the movable sealing part plugs the circumferential wall needle hole when moving forward to abut against the front closed end of the needle cylinder.

Optionally, an axial limiting portion which is located in front of the movable sealing portion and used for limiting the movable sealing portion to move forward is arranged in the inner cavity of the needle cylinder, the eye puncturing device comprises a flow guiding state enabling the injection accommodating area, the peripheral wall needle hole and the front end needle hole to be communicated, the peripheral wall needle hole is located in front of the axial limiting portion in the flow guiding state, and the movable sealing portion can move forward under the action of resilience force between the pressing portions.

Optionally, the eye puncturing device comprises a manual control part connected with the movable sealing part and partially extending out of the needle cylinder.

Optionally, the movable sealing part and the manual control part form a front-back elastic connection.

Optionally, the needle cylinder is provided with a needle cylinder peripheral wall sliding groove extending along the axial direction on the peripheral wall part positioned behind the movable sealing part, the manual control part comprises a pressurization control sliding block in sliding fit with the needle cylinder peripheral wall sliding groove, and the movable sealing part and the pressurization control sliding block are elastically connected in a front-back manner.

Optionally, the eye puncturing device comprises at least one penetrable sealing part which is arranged in the area of the inner cavity of the syringe between the movable sealing part and the front closed end of the syringe and can slide along the axial direction, and the injection accommodating area is formed with a plurality of parts which are separated by the penetrable sealing parts along the axial direction.

Optionally, the eye piercing device further comprises an implant guide for introducing an ocular implant into the needle lumen of the hollow piercing needle.

Optionally, the implant guide structure includes an inclined guide groove formed on the movable sealing portion and extending obliquely toward the hollow puncture needle.

Optionally, the inclined guide groove is arranged to extend through the implant guide structure in the front-rear direction, and the implant guide structure further includes a one-way valve assembly which is embedded in the inclined guide groove and can be opened and closed or a guide groove sealing member which is inserted into the inclined guide groove.

Alternatively, the inclined guide groove is formed on an upper surface of the movable seal portion and is a non-penetrating groove.

Alternatively, the peripheral wall pinhole is formed as an inclined hole that opens obliquely rearward.

Optionally, the implant guide structure includes an inclined guide needle hole formed in a peripheral wall of the hollow puncture needle and opened obliquely rearward, and the eye puncturing device includes a flow guiding state in which the injection accommodating section, the peripheral wall needle hole and the front end needle hole are communicated, and in the flow guiding state, the inclined guide needle hole is located rearward of the movable sealing portion.

Optionally, the implant guide structure further comprises a one-way valve assembly which is embedded in the inclined guide needle hole and can be opened and closed or a needle hole sealing member which is inserted in the inclined guide needle hole.

Optionally, the implant guiding structure includes a middle guiding groove formed in the middle of the rear end face of the pressing portion and capable of being punctured, the hollow puncture needle is formed with a rear end needle hole, and the rear end needle hole and the middle guiding groove are arranged in an axially aligned manner.

Optionally, the eye puncturing device comprises a puncturing control module and a fluid storage module which are processed and formed independently;

the puncture control module comprises a first syringe unit, and the elastic pushing assembly and the hollow puncture needle which are arranged in a syringe cavity of the first syringe unit;

the fluid storage module comprises a second syringe unit, the injection-containing zone formed within a barrel chamber of the second syringe unit, and a module enclosure removably enclosed at a rearward end of the second syringe unit;

a detachable connection structure is formed between the first syringe unit and the second syringe unit.

the puncture control module comprises a first needle cylinder unit, and the pressing part and the hollow puncture needle which are arranged in a cylinder cavity of the first needle cylinder unit;

the fluid storage module comprises a second syringe unit, the injection receiving area formed within a barrel cavity of the second syringe unit, and the movable seal encapsulated at a rearward end of the second syringe unit;

Optionally, the eye puncturing device comprises a puncturing control module, a transition connection module and a fluid storage module which are processed and formed independently;

the transition connection module comprises a second syringe unit and the movable sealing part arranged in a syringe cavity of the second syringe unit;

the fluid storage module comprises a third syringe unit, the injection-containing zone formed within the barrel chamber of the third syringe unit, and a module enclosure removably enclosed at a rearward end of the third syringe unit;

the first syringe unit, the second syringe unit and the third syringe unit are detachably connected in sequence.

In a second aspect, the present invention provides an ocular implant device assembly comprising an ocular implant and an ocular penetration device as described above.

When the eye puncture device is used for puncture, pressure is firstly applied to the pressing part to drive the hollow puncture needle to puncture the front closed end of the needle cylinder, and when the hollow puncture needle punctures the obvious or potential tissue gaps, cavity systems and vessels and the circumferential wall needle hole is positioned in the injection accommodating area, the circumferential wall needle hole and the front end needle hole are communicated. Through reasonable design, the pressure of the eye injection in the injection containing area is higher than the pressure in the visible or potential tissue gaps, cavity systems and vessels, and the eye injection can sequentially flow into the visible or potential tissue gaps, cavity systems and vessels through the peripheral wall needle hole and the front end needle hole under the condition of pressure difference.

In the injection process, the movable sealing part and the pressing part are elastically connected front and back, so that the pressing part is only required to be pressed, the pressing force does not need to be further increased, and the injection agent for the eyes can continuously flow into the needle hole in the peripheral wall under the action of the resilience force between the movable sealing part and the pressing part, so that the injection, the probing and the expansion of the obvious or potential tissue gaps, cavity systems and vessels are realized. In addition, the eye insertion device assembly according to the present invention can also be used to insert a medical device such as an eye implant into an eye using an eye puncturing device provided with an implant guide structure.

Particularly, before the hollow puncture needle is inserted into the obvious or potential tissue gap, the cavity system and the vessel, the external pressure on the front end needle hole is greater than the pressure of the eye injection in the injection accommodating area, so the eye injection cannot flow out of the front end needle hole, and therefore whether the hollow puncture needle is inserted into the obvious or potential tissue gap, the cavity system and the vessel can be judged by observing whether the movable sealing part moves forwards under the action of the resilience force between the movable sealing part and the pressing part, so that the current puncture depth of an operator is reminded, and the accurate control of the puncture depth is ensured. And because the injection is controlled by the pressure change of the injection accommodating area, the applied thrust does not need to be artificially and continuously increased in the injection process, the fluid can be prevented from suddenly and suddenly flowing, and the stable injection is ensured.

Additional features and advantages of the invention will be set forth in the detailed description which follows.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention. In the drawings:

FIGS. 1-5 are schematic views of a medical puncturing device in accordance with an embodiment of the present invention in various states during tissue clearance, cavity system, vessel puncture and fluid injection in an animal;

FIGS. 6-10 are schematic views of another medical puncturing device in accordance with an embodiment of the invention in different states during puncturing of an animal tissue space, a cavity system, a vessel, and an infusion;

FIGS. 11-13 are schematic views showing a portion of a medical puncturing device having a plurality of injection receiving areas according to an embodiment of the present invention in different states;

FIGS. 14-16 are schematic views showing a partial structure of another medical puncturing device having a plurality of injection receiving areas according to an embodiment of the present invention in different states;

FIG. 17 is a partial schematic view of a medical puncturing device having an angled guide slot therethrough and a one-way valve assembly in accordance with an embodiment of the present invention;

FIG. 18 is a partial schematic structural view of a medical instrument assembly incorporating the medical puncturing device of FIG. 17;

FIG. 19 is a partial schematic view of a medical puncturing device having a non-penetrating inclined guide groove according to an embodiment of the present invention;

FIG. 20 is a schematic partial sectional view of a medical puncturing device having an angled guide needle aperture and a one-way valve assembly in accordance with an embodiment of the present invention;

FIG. 21 is a schematic view of a portion of a medical puncturing device having an angled guide needle aperture and needle aperture seal in accordance with an embodiment of the invention;

FIG. 22 is a schematic view of an implant being placed into a tissue space, cavity system, vessel of an animal using a medical instrument assembly having a medial guide channel according to an embodiment of the present invention;

fig. 23-29 illustrate a method for implanting a drainage device in an eye according to an embodiment of the present invention;

FIGS. 30-36 illustrate another method for implanting a drainage device in an eye, in accordance with embodiments of the present invention, to provide a conjunctival incision;

FIGS. 37-42 illustrate another method for implanting a drainage device in an eye without cutting the conjunctiva, according to embodiments of the invention;

FIGS. 43-45 are schematic illustrations of an injection step in a method of implanting a drainage device from an internal pathway into an eye using a medical puncturing device (or medical device assembly) in accordance with an embodiment of the invention;

fig. 46-49 are schematic views of another medical puncturing device in accordance with an embodiment of the invention in different states during tissue clearance, cavity system, vessel puncture and fluid injection in an animal.

Description of reference numerals:

1. pressing part of needle cylinder 2

3. Movable sealing part 4 elastic sheath

5 (5') spring 6 hollow puncture needle

7. Front end sealing member of injection agent containing area 8

9. One-way valve assembly 10 pinhole seal

11. Implant 12 supplemental guide needle

13. Isolating seal part 14 conjunctiva

15. Subconjunctival cavity 16 sclera

17. Choroid 18 suprachoroidal space

19. Anterior chamber of cornea 20

21. Pressure control slide block

1a axial limiting part 2c middle guide groove

3a inclined guide groove 6a front end pinhole

6c inclined guide needle hole of 6b peripheral wall

7a front injection holding area 7b rear injection holding area

6b1 front wall pinhole 6b2 rear wall pinhole

Detailed Description

The following detailed description of embodiments of the invention refers to the accompanying drawings. It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration and explanation only, not limitation.

It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.

In the embodiments of the present invention, the terms "front, back, forward, backward, front, back" and the like are used in accordance with the visual angle of an operator (e.g., surgeon, doctor, nurse, technician, etc.) who uses the medical puncturing device or medical instrument assembly of the present invention, that is, when the operator uses the medical puncturing device or medical instrument assembly, the direction relatively far from the operator is a forward direction, and the direction relatively close to the operator is a backward direction.

The invention will be described in detail below with reference to exemplary embodiments and with reference to the accompanying drawings.

As shown in fig. 1 to 22, a first exemplary embodiment of the present invention provides a medical puncturing device including a cylinder 1, an elastic push unit, a hollow puncturing needle 6, and at least one injection agent accommodating section 7.

Wherein, cylinder 1 includes preceding closed end of cylinder and open end behind the cylinder, when the productization, can design into along the open-ended structure in axial both ends with cylinder 1, through set up front end sealing member 8 in the front end opening part of cylinder 1 in order to realize sealed, this front end sealing member 8 need adopt the material that can be punctured by cavity pjncture needle 6 such as rubber.

Elastic pushing assembly includes pressing portion 2 and movable sealing portion 3, movable sealing portion 3 is arranged in the needle cylinder inner chamber and can move along the axial direction, press portion 2 and stretch out the needle cylinder rear opening end usually at least partially outside in order to supply operating personnel manual pressure, through exerting pressure to pressing portion 2, movable sealing portion 3 with press portion 2 can form front and back elastic connection, if keep pressing the position of portion 2 unchangeably this moment, movable sealing portion 3 with press the rebound force effect between portion 2 and have the trend of moving forward.

Furthermore, the pressing part 2 may further include a portion extending into the inner cavity of the syringe, and the portion may define a sealed area together with the circumferential wall of the inner cavity of the syringe and the movable sealing part 3, that is, a sealed area may be formed behind the movable sealing part 3, and the sealed area may contain a medium, such as a sterilizing gas, which may or may not flow. Or, the part of the pressing part 2 extending into the inner cavity of the syringe can also define a non-sealed area together with the circumferential wall of the inner cavity of the syringe and the movable sealing part 3, that is, the rear part of the movable sealing part 3 can be formed with the non-sealed area for connecting with the external environment.

The hollow puncture needle 6 is fixedly connected to the pressing portion 2, and the hollow puncture needle 6 does not move forward and pierce the front closed end of the cylinder when no pressure is applied to the pressing portion 2, but the state in which the hollow puncture needle 6 pierces the front closed end of the cylinder when the product is shipped is not limited. The hollow puncture needle 6 itself is formed with a tip needle hole 6a and a peripheral needle hole 6b, and the tip needle hole 6a and the peripheral needle hole 6b communicate with each other through the needle chamber of the hollow puncture needle 6.

The injection agent housing section 7 is for storing an injection agent. The injection includes, but is not limited to, liquid, solution, suspension, gel, oil, ointment, emulsion, cream, foam, lotion, paste, etc., which can be stored in the injection-containing region 7 individually or in a mixture. Injectable formulations preferably employ easily manipulated liquids (e.g., solutions, suspensions, etc.) or semi-solid compositions (e.g., gels), and are preferably capable of setting after injection and expansion of tissue spaces, cavities, vessels. For example, injection may be made at or near the target site, and the injection subsequently coagulated and set, possibly with greater strength to maintain a dilated tissue space, cavity system, vessel.

Injections may be flowable, including preparations with low viscosity, high viscosity, or water-like viscosity, such as paste-like materials. The fluidity of the formulation may allow it to conform to irregularities, crevices and/or voids of the tissue site. For example, the formulation can be used to fill one or more voids, enlarge tissue voids (e.g., manifest tissue voids) and/or form potential tissue voids into manifest tissue voids, and optionally enlarge the resulting voids. In addition, some injectable agents may also harden upon contact with aqueous media (e.g., body fluids, water, etc.) to form a drug depot that facilitates controlled release of the drug.

The injection containing area 7 is formed in the inner cavity area of the syringe which is enclosed by the front closed end of the syringe, the circumferential wall of the inner cavity of the syringe and the movable sealing part 3. Since the movable seal portion 3 is movable in the axial direction during injection, the injection agent containing region 7 has a variable volume, so that the injection agent pressure in the injection agent containing region 7 can be varied with the axial movement of the movable seal portion 3.

When puncturing with the medical puncturing device of the present exemplary embodiment, the hollow puncturing needle 6 can be pushed forward by applying pressure to the pressing part 2 to puncture the front closed end of the cylinder, and when the hollow puncturing needle 6 punctures the exposed or potential tissue space, cavity system, vessel and the peripheral wall needle hole 6b is located in the injection agent accommodating area 7, the peripheral wall needle hole 6b and the front end needle hole 6a communicate. Through reasonable design, the pressure of the injection in the injection containing area 7 can be higher than the pressure in the apparent or potential tissue gaps, cavity systems and vessels, and the injection can sequentially flow into the apparent or potential tissue gaps, cavity systems and vessels through the peripheral wall needle hole 6b and the front end needle hole 6a under the condition of pressure difference.

In the injection process, the movable sealing part 3 and the pressing part 2 are elastically connected front and back, so that the injection can continuously flow into the pinhole 6b on the peripheral wall under the action of the resilience force between the movable sealing part 3 and the pressing part 2 without further increasing the pressing force by only keeping the pressing part 2 pressed, and the injection, probing and expansion of visible or potential tissue gaps, cavity systems and vessels are realized.

Before the hollow puncture needle 6 penetrates into the apparent or potential tissue space, cavity system, vessel, the external pressure at the front needle hole 6a is larger than the injection agent pressure in the injection agent containing area 7, so that the injection agent can not flow out from the front needle hole 6 a. For example, in the case of the process of puncturing the suprachoroidal space of the eye, when the hollow puncture needle 6 punctures the sclera but does not puncture the suprachoroidal space, no matter whether the peripheral wall needle hole 6b is communicated with the injection accommodation region 7, the injection does not flow out from the front end needle hole 6a, because the sclera is dense, when the front end needle hole 6a is located in the sclera, it is equivalent to that a large external pressure is formed at the front end needle hole 6a, and the external pressure is greater than the injection pressure in the injection accommodation region 7, so that the injection cannot flow out.

Therefore, whether the movable sealing part 3 moves forwards under the action of resilience force between the movable sealing part and the pressing part 2 or not can be observed, whether the hollow puncture needle 6 is punctured into a visible or potential tissue gap, cavity system or vessel can be judged, the current puncture depth of an operator is reminded, and the accurate control of the puncture depth is ensured. And because the injection is controlled by the pressure change of the injection in the injection containing area 7, the applied thrust does not need to be manually increased in the injection process, the injection can be prevented from being suddenly and suddenly delayed, and the stable injection is ensured.

In some embodiments, the medical puncturing device further comprises at least one pierceable isolation seal 13 disposed in the region of the syringe cavity between the movable seal 3 and the front closed end of the syringe and capable of sliding in the axial direction. In this structure, the injection agent housing section 7 is formed in plural, and the plural injection agent housing sections 7 are arranged in series in an axially spaced manner by the isolation seal portion 13. Wherein, a plurality of injection agent containing areas 7 can store the same injection agent and can also store different injection agents.

For example, referring to fig. 11 to 16, the injection agent housing section 7 includes a front injection agent housing section 7a and a rear injection agent housing section 7b which are separated front and rear.

In the embodiment shown in fig. 11 to 13, the peripheral wall pin holes 6b include front and rear peripheral wall pin holes arranged at a front-rear interval. Under this structure, if the hollow puncture needle 6 is first punctured to make the front wall needle hole communicate with the front injection agent containing area 7a and the rear wall needle hole is surrounded and sealed by the isolation sealing part 13, the injection agent in the front injection agent containing area 7a will flow into the apparent or potential tissue gap, cavity system and vessel through the front wall needle hole and the front end needle hole 6a in sequence, under the effect of the resilience force between the movable sealing part 3 and the pressing part 2, the injection amount in the front injection agent containing area 7a is continuously reduced, and the movable sealing part 3 and the isolation sealing part 13 are continuously moved forward. Through reasonable design, before the front circumferential wall needle hole is blocked by the isolation sealing part 13, the rear circumferential wall needle hole is communicated with the rear injection accommodating area 7b, so that the injection in the rear injection accommodating area 7b sequentially flows into the apparent or potential tissue gaps, cavity systems and vessels through the rear circumferential wall needle hole and the front end needle hole 6 a. Thus, in this embodiment, sequential injection of injectate within the front and back injectate-containing

zones

7a and 7b into the apparent or potential tissue spaces, vasculature can be achieved.

In another embodiment shown in fig. 11 to 13, the hollow puncture needle 6 may be punctured such that the front wall needle hole communicates with the front injection agent containing region 7a and the rear wall needle hole communicates with the rear injection agent containing region 7b, thereby mixing the injection agents in the front injection agent containing region 7a and the rear injection agent containing region 7b and injecting the mixture into the apparent or potential tissue space, cavity system, or vessel.

In the embodiment shown in fig. 14 to 16, only one peripheral needle hole 6b is provided, and by proper design, the hollow puncture needle 6 can be punctured such that the front portion of the peripheral needle hole 6b communicates with the front injection agent housing area 7a and the rear portion of the peripheral needle hole 6b is enclosed and sealed by the isolation seal portion 13. At this time, the injection in the front injection housing area 7a flows into the apparent or potential tissue gap, cavity system, and vessel through the front part of the peripheral wall needle hole 6b and the front end needle hole 6a, and the injection in the front injection housing area 7a is reduced by the resilient force between the movable seal part 3 and the pressing part 2, and the movable seal part 3 and the separation seal part 13 are moved forward. Also, by proper design, the rear part of the peripheral wall needle hole 6b can be communicated with the back injection containing area 7b before the isolation sealing part 13 blocks the front part of the front peripheral wall needle hole, so that the injection in the back injection containing area 7b can flow into the apparent or potential tissue gaps, cavity systems and vessels through the rear part of the peripheral wall needle hole 6b and the front end needle hole 6a in sequence. Thus, in this embodiment, sequential injection of injectate within the front and back injectate-containing

zones

7a and 7b into the apparent or potential tissue spaces, vasculature can also be achieved.

In another embodiment shown in fig. 14 to 16, the hollow puncture needle 6 may be punctured such that the front portion of the peripheral wall needle hole 6b communicates with the front injection agent housing section 7a, the rear portion of the peripheral wall needle hole 6b communicates with the rear injection agent housing section 7b, and the portion between the front portion and the rear portion of the peripheral wall needle hole 6b is sealed by the separation seal section 13, thereby enabling the injection agents in the front injection agent housing section 7a and the rear injection agent housing section 7b to be mixed and then injected into the apparent or potential tissue spaces, cavity systems, vessels.

It should be noted that the explicit or potential interstitial spaces, cavity systems, and vessels described herein may be suprachoroidal space, epidural space, pleural space, peritoneal cavity, joint cavity, artery, vein, etc., and are not particularly limited, so that the medical puncturing device of the present exemplary embodiment also has an advantage of strong versatility.

The specific position of the hollow puncture needle 6 may be slightly different after the medical puncture device of the present exemplary embodiment is shipped and before it is used, that is, the medical puncture device may be set in various shipping forms.

For example, the hollow piercing needle 6 has punctured the movable seal 3 but not the front closed end of the barrel. At this time, the peripheral wall needle hole 6b may be located behind the movable sealing portion 3, enclosed and sealed by the movable sealing portion 3 or communicated with the injection agent containing area 7, and the front end needle hole 6a may be communicated with the injection agent containing area 7 or enclosed and sealed by the front closed end of the syringe.

Alternatively, the hollow piercing needle 6 has pierced the movable seal 3 and the forward closed end of the barrel. At this time, the peripheral wall needle hole 6b may be located behind the movable sealing portion 3, enclosed and sealed by the movable sealing portion 3 or communicated with the injection agent accommodating area 7, and the front end needle hole 6a is located outside the front closed end of the syringe.

Alternatively, the hollow puncture needle 6 does not puncture the movable seal portion 3, i.e., the entire portion is located rearward of the movable seal portion 3. Accordingly, the peripheral wall pin hole 6b and the front end pin hole 6a are both located rearward of the movable seal portion 3.

Therefore, as long as the peripheral wall needle hole 6b is not communicated with the injection accommodating area 7 when the product is delivered from the factory, the possibility that the injection leaks from the front end needle hole 6a before puncturing can be avoided no matter whether the hollow puncturing needle 6 punctures the movable sealing part 3 and the front closed end of the needle cylinder or not and whether the front end needle hole 6a is positioned outside the front closed end of the needle cylinder or not.

In fact, as can be seen from the foregoing, if the external pressure applied to the front needle hole 6a before the communication between the exposed or potential tissue gaps, cavity systems, and vessels is made larger than the pressure of the injection agent in the injection agent containing region 7 by proper design, even if the peripheral needle hole 6b communicates with the injection agent containing region 7 at the time of product shipment, the injection agent does not leak out from the front needle hole 6a in advance.

Further, in the case where the injection agent flows backward as the peripheral wall needle hole 6b is located behind the movable seal portion 3 and the front end needle hole 6a is located in the injection agent accommodation area 7, a corresponding embodiment will be described as a remedy, and will not be described in detail here.

In different product forms, it is preferable that the hollow puncture needle 6 does not puncture the movable seal portion 3 when the product is shipped, that is, the hollow puncture needle 6 is entirely located behind the movable seal portion 3. When the medical puncture device with the factory-leaving shape is used for puncture, the pressing part 2 is pressed to drive the hollow puncture needle 6 to puncture the movable sealing part 3 and the front closed end of the needle cylinder forwards in sequence until the front end needle hole 6a enters the apparent or potential tissue gap, cavity system and vessel and the peripheral wall needle hole 6b is communicated with the injection accommodating area 7.

In order to ensure that the hollow puncture needle 6 can finally puncture the front closed end of the needle cylinder, a puncture guide structure such as a guide groove, a guide blind hole or a guide slit for guiding the hollow puncture needle 6 to puncture can be arranged on the rear end face of the movable sealing part 3.

After the hollow puncture needle 6 punctures the front closed end of the needle cylinder, the medical puncture device at least comprises two different states, namely a surface tissue puncture state and a flow guiding state.

In the surface tissue puncture state, the length range of the hollow puncture needle 6 extending from the front closed end of the needle cylinder is the surface tissue puncture length range, in the range, the front end of the hollow puncture needle 6 penetrates into the surface tissue but does not penetrate into the apparent or potential tissue gaps, cavities and vessels, and because the surface tissue is compact, the external pressure applied to the front end needle hole 6a is greater than the injection pressure in the injection containing area 7, so the injection cannot flow out no matter whether the peripheral wall needle hole 6b is communicated with the injection containing area 7 or not.

In the diversion state, the length range of the hollow puncture needle 6 extending from the front closed end of the needle cylinder is the diversion length range, and in the diversion length range, the hollow puncture needle 6 is already inserted into the obvious or potential tissue gaps, cavity systems and vessels. As previously mentioned, proper design can be used to ensure that the pressure of the injectate within the injectate-containing region 7 is greater than the pressure within the apparent or potential tissue space, cavity system, or vessel. When the peripheral wall needle hole 6b is communicated with the injection containing area 7, under the condition of internal and external pressure difference, the injection in the injection containing area 7 can flow into the apparent or potential tissue gaps, cavity systems and vessels through the peripheral wall needle hole 6b and the front end needle hole 6a in sequence.

Various alternative embodiments for controlling the stopping of the injection operation of the medical puncturing device are described below.

In one embodiment, when the medical puncturing device is in a flow guiding state, the movable sealing part 3 can move forwards to block the peripheral wall needle hole 6b under the action of the resilience force between the movable sealing part and the pressing part 2, and the liquid injection action is stopped immediately after the peripheral wall needle hole 6b is blocked. It follows that the axial position of the peripheral wall needle hole 6b in the injection agent containing section 8 defines the maximum injection amount of the medical puncturing device.

For example, when the injection storage area 7 needs to be emptied, the movable seal 3 may be limited to close off the peripheral needle hole 6b when moving forward to abut against the front closed end of the cylinder, so that the peripheral needle hole 6b is located at the front end of the injection storage area 7. However, in practice, as the injection in the injection storage section 7 gradually flows into the apparent or potential tissue space, cavity system, or vessel, the pressure of the injection in the injection storage section 7 is equal to the pressure in the apparent or potential tissue space, cavity system, or vessel, and the movable seal portion 3 is not moved due to the force balance. To evacuate the injection agent containing region 7, the forward pushing force applied to the movable seal portion 3 is also increased.

For example, referring to the embodiment shown in fig. 6 to 10, a sliding groove (not shown) extending along the axial direction may be provided on the circumferential wall of the syringe 1, and a sliding block (i.e. the portion of the pressing portion 2 extending out of the syringe 1) matching with the sliding groove may be provided on the pressing portion 2, so that the upper limit of the pressing moving stroke of the pressing portion 2 is larger, when the movable sealing portion 3 is no longer moving due to the balance of the forces, a larger pressing force may be applied to the sliding block of the pressing portion 2, the pressing portion 2 is driven to move forward continuously, the resilience between the movable sealing portion 3 and the pressing portion 2 is increased, the balance of the forces of the movable sealing portion 3 is broken, and the movable sealing portion 3 is moved forward continuously, so that the injection agent accommodating area 7 may discharge more fluid, even empty.

Alternatively, the movable seal 3 may be further urged into abutment with the forward closed end of the barrel by other actuation arrangements, an alternative of which will be described in the following examples.

In another embodiment, the medical puncturing device comprises a manual control part which is connected with the movable sealing part 3 and partially extends out of the syringe. For example, the movable sealing portion 3 may be elastically connected with the manual control portion in the front-rear direction, or the manual control portion may be directly fixedly connected with the movable sealing portion 3, but obviously, in the case of forming the elastic connection, it is more beneficial to maintain a stable liquid injection speed.

When the injection dosage injected into the visible or potential tissue gaps, cavity systems and vessels does not reach the preset target and the movable sealing part 3 does not move any more due to the stress balance, the operator can control the part of the manual control part extending out of the needle cylinder to drive the movable sealing part 3 to move forwards continuously until the externally-discharged injection dosage reaches the preset target. With the solution of the present embodiment, the problem that the injection agent accommodating section 7 cannot be emptied in the previous embodiment can be solved. Of course, the present embodiment is not limited to the case where the injection agent accommodating section 7 is to be emptied.

Referring to fig. 46 to 49, a cylinder peripheral wall sliding groove extending along the axial direction may be provided on the peripheral wall portion of the cylinder 1 behind the movable sealing portion 3, in this case, the manual control portion includes a pressure control slider 21 slidably engaged with the cylinder peripheral wall sliding groove, the pressure control slider 21 extends out of the cylinder 1 through the cylinder peripheral wall sliding groove portion for user's operation, and the movable sealing portion 3 and the pressure control slider 21 form a front-rear elastic connection, for example, a spring 5' is provided between the movable sealing portion 3 and the pressure control slider 21 as shown in the figure. Under the structure, the pressure is further applied on the pressure control slide block 21 to enable the pressure control slide block to slide forwards along the axial direction of the chute on the peripheral wall of the needle cylinder, so that the movable sealing part 3 and the pressure control slide block 21 can be elastically compressed, and when the position of the pressure control slide block is kept, the movable sealing part 3 can break the stress balance state and continuously move forwards under the action of resilience force until the discharged injection dose reaches the original target.

In another embodiment, the medical puncturing device is adapted to effect a metered dose injection of an injection agent. Specifically, referring to fig. 1 to 10, an axial direction limiting portion 1a for limiting the forward movement of the movable sealing portion 3 is disposed in front of the movable sealing portion 3 in the inner cavity of the syringe, and when the medical puncturing device is in the fluid conducting state, the peripheral wall needle hole 6b is disposed in front of the axial direction limiting portion 1a, and the movable sealing portion 3 can move forward under the effect of the resilient force between the movable sealing portion and the pressing portion 2.

To realize that the movable seal part 3 moves to be limited by the axial limiting part 1a, two conditions are adopted:

in the first case, until the movable sealing portion 3 moves to be limited by the axial limiting portion 1a, the pressure of the injection in the injection containing region 7 is still not less than the pressure in the apparent or potential tissue gap, cavity system, or vessel, in other words, at this time, the movable sealing portion 3 can be pushed forward to be limited by the axial limiting portion 1a only by the resilience between the movable sealing portion 3 and the pressing portion 2 without using other driving structures.

The second case is that before the movable sealing part 3 is pushed to abut against the axial limiting part 1a under the effect of the resilience force between the movable sealing part 3 and the pressing part 2, the pressure of the injection in the injection containing area 7 is the same as the pressure in the apparent or potential tissue gap, cavity system and vessel (i.e. the movable sealing part 3 is not moved any more due to the force balance), at this time, the movable sealing part 3 cannot be pushed to be limited by the axial limiting part 1a only by virtue of the resilience force between the movable sealing part 3 and the pressing part 2, so that the movable sealing part 3 needs to be further pushed forward by an additionally arranged driving structure, for example, the driving structure can be the aforementioned manual control part. In either case, the axial stopper 1a provided in the present embodiment is the basis for achieving the injection of a fixed amount of the injection agent.

The following describes a plurality of different puncture and injection timings of the medical puncture device.

In one embodiment, the peripheral wall needle hole 6b is always kept above the injection agent containing area 7 before the hollow puncture needle 6 extends out of the front closed end of the needle cylinder, so that the phenomenon of early leakage at the front end needle hole 6a can be avoided, and the reliability of the medical puncture device can be improved.

In another embodiment, the peripheral needle hole 6b is at least partially in communication with the injection agent containing region 7 when the medical puncturing device is in a superficial tissue puncturing state, i.e., when the hollow puncturing needle 6 extends from the front closed end of the barrel to a length within a superficial tissue puncturing length (or when the front end of the hollow puncturing needle 6 penetrates into superficial tissue but not into the superficial or potential tissue spaces, cavities, or vessels). In other words, before the front end of the hollow puncture needle 6 is inserted into the apparent or potential tissue space, cavity system or vessel, the injection agent containing region 7, the peripheral wall needle hole 6b and the front end needle hole 6a are communicated in advance, so that the injection agent is injected into the needle cavity of the hollow puncture needle 6 in advance, at least a part of air is discharged, and the air quantity entering the apparent or potential tissue space, cavity system or vessel is reduced.

More preferably, when the front end of the hollow puncture needle 6 starts to penetrate into the superficial tissues, the needle hole 6b of the peripheral wall starts to communicate with the injection agent containing area 7, so that when the front end of the hollow puncture needle 6 penetrates into the visible or potential tissue gaps, cavity systems and vessels, the needle cavity of the hollow puncture needle 6 is filled with the injection agent, and the possibility of air entering the visible or potential tissue gaps, cavity systems and vessels is completely eliminated.

In another embodiment, when the medical puncturing device is in a diversion state, that is, when the length of the hollow puncturing needle 6 extending from the front closed end of the syringe is within the diversion length range (or when the front end of the hollow puncturing needle 6 is punctured into a visible or potential tissue space, cavity system or vessel), the peripheral needle hole 6b is already completely positioned in the injection accommodating area 7, so that the flow rate of the peripheral needle hole 6b is maximized, and the injection speed is increased.

The above three embodiments may be implemented individually or in combination.

An embodiment capable of preventing the reverse flow of the fluid to be discharged from the peripheral wall needle hole 6b in the reverse direction will be described.

When the front end needle hole 6a is communicated with the injection accommodating area 7 and the peripheral wall needle hole 6b is still positioned behind the movable sealing part 3, or when the front end needle hole 6a is positioned in a visible or potential tissue gap, cavity system or vessel and the peripheral wall needle hole 6b is still positioned behind the movable sealing part 3, the risk that the injection flows backwards and reversely overflows from the peripheral wall needle hole 6b exists. Therefore, an elastic sheath 4 sleeved outside the hollow puncture needle 6 can be arranged in the elastic pushing component, when the peripheral wall needle hole 6b is positioned at the rear part of the movable sealing part 3 (namely when the peripheral wall needle hole 6b is not communicated with the injection accommodating area 7), the elastic sheath 4 can keep blocking the peripheral wall needle hole 6b, thereby effectively avoiding the backflow and overflow of the injection, preventing the rear area of the movable sealing part 3 from being polluted, reducing the fluid loss and improving the product reliability.

In fact, the elastic sheath 4 can be used only as an elastic connection member between the movable seal portion 3 and the pressing portion 2, even if it is not used for closing the circumferential wall pin hole 6b. Specifically, by pressing the pressing portion 2 forward, the elastic sheath 4 between the movable seal portion 3 and the pressing portion 2 is pressed, so that a resilient force is formed between the movable seal portion 3 and the pressing portion 2, driving the movable seal portion 3 to move forward. The elastic connection member between the movable seal portion 3 and the pressing portion 2 may be a spring 5 having both axial ends connected to the movable seal portion 3 and the pressing portion 2, respectively. The spring 5 and the elastic sheath 4 may be provided separately or in combination.

The elastic connection between the movable seal portion 3 and the pressing portion 2 may be achieved by means other than the provision of the elastic connection member. For example, the movable seal portion 3 and the pressing portion 2 may be provided as an integrally molded elastic member.

Various embodiments of the ability to implant medical devices into apparent or potential tissue spaces, systems, vessels by means of a medical puncturing device are described below, respectively, and for ease of understanding, the implanted medical devices are illustrated as being wire-like or tubular implants 11, although implants 11 may also be needle-like implants, electrodes, sensors, etc.

Specifically, an implant guide structure for introducing the implant 11 into the needle chamber of the hollow puncture needle 6 is provided in the medical puncture device.

In one embodiment, referring to fig. 17 to 19, the implant guide structure includes an inclined guide groove 3a formed on the movable sealing portion 3 and extending obliquely toward the hollow puncture needle 6. When the injection accommodating area 7, the peripheral wall needle hole 6b and the front end needle hole 6a are communicated, firstly, the injection is ready to be exposed or potential tissue gaps, cavity systems and vessels are expanded, and then the implant 11 is implanted into the expanded exposed or potential tissue gaps, cavity systems and vessels through the inclined guide groove 3a, the peripheral wall needle hole 6b, the needle cavity of the hollow puncture needle 6 and the front end needle hole 6 a.

The inclined guide groove 3a may be a through groove that penetrates in the front-rear direction, or may be a non-through groove formed in the upper surface of the movable seal portion 3.

When the inclined guide groove 3a is a through groove, the implant guide structure may further include a one-way valve assembly 9 which is embedded in the inclined guide groove 3a and can be opened and closed, the one-way valve assembly 9 is in a normally closed state when no external force is applied, so as to prevent the injection in the injection containing area 7 from leaking from the one-way valve assembly, but when an opening force is applied, a plurality of valves of the one-way valve assembly can be opened, so that the implant 11 can penetrate into the circumferential wall needle hole 6b from the opening port. Alternatively, the implant guiding structure may include a guiding groove sealing member inserted into the inclined guiding groove 3a, and when the implant 11 is to be implanted, the guiding groove sealing member is firstly pulled out.

When the inclined guide groove 3a is a non-through groove, it may be directly pierced by the implant 11, or after piercing with another piercing member, the implant 11 may be passed through the piercing opening to penetrate the peripheral needle hole 6b.

In this embodiment, in order to match the guide of the inclined guide groove 3a, the peripheral wall needle hole 6b may be provided as an inclined hole opened toward the obliquely rear direction, so that the peripheral wall needle hole 6b can be aligned with the inclined guide groove 3a to accurately introduce the implant 11.

In another embodiment, referring to fig. 20 and 21, the implant guiding structure includes an inclined guiding needle hole 6c formed in the peripheral wall of the hollow puncture needle 6 and opened obliquely backward, the inclined guiding needle hole 6c is always kept backward of the movable sealing portion 3 in the fluid guiding state of the medical puncture device, and the implant 11 can be inserted into the needle cavity of the hollow puncture needle 6 through the inclined guiding needle hole 6c and implanted into the expanded exposed or potential tissue space, cavity system, or vessel through the front end needle hole 6 a.

Similar to the previous embodiment, the implant guiding structure may further comprise a retractable one-way valve assembly 9 inserted into the inclined guiding needle hole 6c or a needle hole sealing member 10 inserted into the inclined guiding needle hole 6c, and the implant 11 can be implanted by first expanding the one-way valve assembly 9 or pulling out the needle hole sealing member 10.

In another embodiment, referring to fig. 22, the implant guide structure includes a center guide groove 2c formed at a center position of the rear end surface of the pressing part 2 and pierced, and the hollow puncture needle 6 is formed with a rear end needle hole which is axially aligned with the center guide groove 2 c. When the implant 11 needs to be implanted, the middle guide groove 2c can be punctured, then the implant 11 is inserted into the needle cavity of the hollow puncture needle 6 through the puncture hole of the middle guide groove 2c and the rear end needle hole of the hollow puncture needle 6, and then the implant can be further implanted into the expanded apparent or potential tissue gaps, cavity systems and vessels through the front end needle hole 6 a.

Several embodiments of medical puncturing devices formed in a split-mount configuration are described below.

In one embodiment, a medical puncturing device includes a puncturing control module and a fluid storage module that are formed separately from each other. The puncture control module comprises a first syringe unit, an elastic pushing assembly and a hollow puncture needle 6, wherein the elastic pushing assembly and the hollow puncture needle are arranged in a barrel cavity of the first syringe unit, and the puncture control module can further comprise an elastic sheath 4, a spring 5 and other components in combination with the different embodiments. And the fluid storage module comprises a second syringe unit, an injection agent receiving area 7 formed in the chamber of the second syringe unit, and a module package removably packaged at the rear end of the second syringe unit. A detachable connection structure is formed between the first syringe unit and the second syringe unit, and the first syringe unit and the second syringe unit are spliced with each other to form the syringe 1. As will be appreciated in connection with the various embodiments described above, the fluid storage module may also include components such as a front seal 8.

Therefore, the puncture control module and the fluid storage module can be respectively produced and then assembled into the medical puncture device. The module package is used to seal the rear end of the injectant receiving area 7 and can be removed when the penetration control module and fluid storage module are assembled.

In another embodiment, a medical puncturing device includes a puncturing control module and a fluid storage module that are formed separately from each other. The puncture control module comprises a first syringe unit, a pressing part 2 and a hollow puncture needle 6, wherein the pressing part and the hollow puncture needle are arranged in a barrel cavity of the first syringe unit, and the puncture control module can further comprise an elastic sheath 4, a spring 5 and other components in combination with the different embodiments. And the fluid storage module includes a second syringe unit, an injection agent housing area 7 formed in a chamber of the second syringe unit, and a movable seal 3 sealed at a rear end of the second syringe unit, where the movable seal 3 is for sealing a rear end of the injection agent housing area 7. A detachable connection structure is formed between the first needle cylinder unit and the second needle cylinder unit, the first needle cylinder unit and the second needle cylinder unit are spliced with each other to form a needle cylinder 1, and the movable sealing part 3 and the pressing part 2 are elastically connected in a front-back mode. As will be appreciated in connection with the various embodiments described above, the fluid storage module may also include components such as a front seal 8.

In another embodiment, a medical puncturing device includes a puncturing control module, a transition connection module, and a fluid storage module that are formed separately from one another. The puncture control module comprises a first syringe unit, and a pressing part 2 and a hollow puncture needle 6 which are arranged in a barrel cavity of the first syringe unit, and can also comprise an elastic sheath 4, a spring 5 and other components in combination with the different embodiments. The transitional coupling module comprises a second syringe unit and a movable seal 3 arranged in the chamber of the second syringe unit. The fluid storage module includes a third syringe unit, an injection receiving area 7 formed in a barrel chamber of the third syringe unit, and a module package removably packaged at a rear end of the third syringe unit. The first needle cylinder unit, the second needle cylinder unit and the third needle cylinder unit are sequentially detachably connected, the first needle cylinder unit, the second needle cylinder unit and the third needle cylinder unit are sequentially spliced to form the needle cylinder 1, and the movable sealing part 3 and the pressing part 2 are elastically connected in front and back. As will be appreciated in connection with the various embodiments described above, the fluid storage module may also include components such as a front seal 8.

A second exemplary embodiment of the present invention provides a medical device assembly, referring to fig. 18 and 22, comprising an implant 11 and a medical puncturing device provided with an implant guiding structure as described above, thereby enabling implantation of the implant 11 by the medical puncturing device into the animal's apparent or potential tissue space, cavity system, vasculature (including but not limited to the suprachoroidal space, epidural space, pleural space, peritoneal cavity, joint space, artery, vein). In addition, the medical instrument assembly in the exemplary embodiment obviously has all the technical effects brought by the medical puncturing device, and therefore, the detailed description thereof is omitted.

In one embodiment, the medical instrument assembly further comprises a hollow auxiliary guide needle 12 adapted for use with the implant guide structure, the needle bore of the auxiliary guide needle 12 being of a size sufficient for the implant 11 to penetrate. When the implantation operation of the implant 11 is performed, the auxiliary guide needle 12 is firstly connected with the implant guide structure, the implant 11 can sequentially pass through the needle cavity of the auxiliary guide needle 12 and the implant guide structure to be guided into the needle cavity of the hollow puncture needle 6, and then the obvious or potential tissue gaps, cavity systems and vessels are implanted through the front end needle hole 6 a.

For example, referring to fig. 18, the implant guide structure includes a through inclined guide groove 3a and a one-way flap assembly 9 fitted into the inclined guide groove 3a and openable and closable, and a peripheral wall needle hole 6b is provided as an inclined hole opening obliquely rearward. When the implant 11 is implanted, the one-way valve assembly 9 is firstly opened by the auxiliary guide needle 12 to penetrate through the inclined guide groove 3a, the front end of the auxiliary guide needle 12 penetrates through the peripheral wall needle hole 6b, and then the implant 11 is implanted into the visible or potential tissue gaps, cavity systems and vessels sequentially through the needle cavity of the auxiliary guide needle 12, the needle cavity of the hollow puncture needle 6 and the front end needle hole 6 a.

In another embodiment, the implant guiding structure comprises an inclined guiding groove 3a penetrating in the front-back direction and a guiding groove sealing member inserted into the inclined guiding groove 3a, and the auxiliary guiding needle 12 can puncture the guiding groove sealing member forward and the front end penetrates into the peripheral wall needle hole 6b, thereby communicating with the needle cavity of the hollow puncture needle 6.

In another embodiment, the inclined guide groove 3a is formed on the upper surface of the movable seal portion 3 and is a non-through groove, and the auxiliary guide needle 12 can penetrate the inclined guide groove 3a forward and the leading end penetrates the peripheral wall needle hole 6b, thereby communicating the needle chamber of the hollow puncture needle 6.

The peripheral wall needle hole 6b in the above embodiment may be formed as an inclined hole opened toward the obliquely rear direction so that the leading end of the auxiliary guide needle 12 can be aligned with the inclined hole when the auxiliary guide needle 12 passes through the inclined guide groove 3a.

In another embodiment, the implant guiding structure comprises an inclined guiding needle hole 6c formed in the peripheral wall of the hollow puncture needle 6 and opening towards the inclined rear, in the flow guiding state of the medical puncture device, the inclined guiding needle hole 6c is positioned at the rear of the movable sealing part 3, and the auxiliary guiding needle 12 can extend into the inner cavity of the syringe from the rear opening end of the syringe and penetrate into the inclined guiding needle hole 6c, so as to communicate with the needle cavity of the hollow puncture needle 6.

Further, the implant guide structure may further comprise a one-way valve assembly 9 embedded and openable in the inclined guide needle hole 6c or a needle hole sealing member 10 inserted in the inclined guide needle hole 6c, so that the auxiliary guide needle 12 can forwardly open the one-way valve assembly 9 or forwardly pierce the needle hole sealing member 10 to communicate with the needle chamber of the hollow puncture needle 6.

Alternatively, referring to fig. 22, the implant guide structure includes a central guide groove 2c, and the hollow puncture needle 6 is formed with a rear end needle hole which is axially aligned with the central guide groove 2 c. When the implant 11 is implanted, the auxiliary guide needle 12 is firstly utilized to puncture the middle guide groove 2c, so that the auxiliary guide needle 12 is axially aligned with the rear end needle hole of the hollow puncture needle 6, then the implant 11 passes through the needle cavity of the auxiliary guide needle 12 and the rear end needle hole of the hollow puncture needle 6 in sequence to penetrate into the needle cavity of the hollow puncture needle 6, and then the obvious or potential tissue gaps, cavity systems and vessels are implanted through the front end needle hole 6 a.

The medical puncturing device and medical instrument assembly of the present invention may be used for the insertion, distraction, injection of the cavity system, such as the suprachoroidal space of the eye, and the implantation of drugs, catheters, or other medical devices. The most common form of intraocular injection is intravitreal injection, but some drugs or gene therapy vectors are less effective at penetrating the posterior limiting membrane of the vitreous and the inner retinal structures to the outer retinal layer or retinal pigment epithelium layer. In addition, since the vitreous cavity is a semi-open cavity, the drug injected in the vitreous cavity easily flows out of the eyeball along with the circulation of aqueous humor, affects the local concentration and pharmacokinetics of the drug, and may also cause side effects such as increased intraocular pressure and cataract. In some cases, in order to achieve effective concentration of the drug or gene therapy vector in the outer retina, retinal pigment epithelium and/or choroid, the hollow puncture needle may be inserted into the retina to the subretinal space or the retina and retinal pigment epithelium to the retinal pigment epithelium space at the vitreous chamber side, and then the drug or gene therapy vector may be injected, which may result in difficulty in injection and failure of injection.

Suprachoroidal injection allows for higher drug concentration routes of administration in the choroid, retinal pigment epithelium, and/or outer retina, with lower vitreous drug concentrations.

In some cases, such as choroidal melanoma, precise targeted injection of a therapeutic agent into the suprachoroidal space may improve efficacy and reduce side effects. However, the eye has a small structure, and it is difficult to insert a medical device such as a catheter into the suprachoroidal space, particularly at a specific location, by using an existing device or method.

Some suprachoroidal space puncture methods are characterized in that the length of the exposed puncture needle is equivalent to the thickness of sclera, and the puncture needle is completely inserted into the sclera and then injected with fluid to realize suprachoroidal space injection. The technical drawback of this type of puncture is that the exposed length of the puncture needle and the thickness of the sclera may not be completely uniform. In practice, the difference in scleral thickness between different persons, between eyes, and between different parts of the same eye further amplifies the above technical disadvantages. A needle that is too short may not penetrate the sclera and a needle that is too long may pass over the suprachoroidal space and damage the retina. Therefore, a device or a method capable of easily determining the penetration depth of the needle end is also needed.

Because intraocular injections have sensitivity (e.g., tissue sensitivity, potential effects on intraocular pressure, etc.), many known devices and methods involve manual injection. More specifically, many known devices and methods require a user to manually apply force (e.g., by pushing a plunger with his thumb or finger) to expel a fluid (e.g., a drug) into an eye. Due to the small size of the needle and/or the nature of the injected medicament, such devices and methods do not allow the operator to operate and apply force with relative comfort, and in some cases, the operator may not even be able to properly deliver the medicament using known devices and methods.

In addition, injection into different target layers of the eye may cause the amount of force required to inject the inserted needle and/or the drug to vary. Different layers of the eye may have different densities. For example, the sclera is typically denser than the conjunctiva and the suprachoroidal space. The difference in density of the target area or target layer may create different external pressures at the needle port. Thus, injection into relatively dense ocular tissue such as the sclera requires more power to expel the drug from the needle port than injection of the drug into the suprachoroidal space. In addition, the injection force required to expel the drug also depends on the density and viscosity of the drug and the length and diameter of the needle. Some medications injected through a needle (e.g., 27G, 30G or even smaller needles) into the eye may require the application of forces that are difficult to estimate and/or control in order to achieve proper injection without damaging the eye tissue.

Likewise, placement of instruments into the intraocular region (e.g., a catheter or wire placed into the desired region using minimally invasive methods) can be quite challenging given the relatively small size of the ocular structures.

In view of the foregoing, it is apparent that the medical puncturing device and the medical instrument assembly according to the present invention can easily perform operations of injection, penetration, expansion, or instrument implantation to an intraocular region such as the suprachoroidal space, and particularly can realize accurate control of the puncturing depth, stable injection, and quantitative injection.

In order to allow easy penetration with minimal collateral damage, such as penetration of the sclera to the suprachoroidal space, the penetration may be performed using a hollow needle 6 with a beveled front needle face. The hollow puncture needle 6 may also be provided with a narrow needle lumen (e.g., a gauge size of 30G, 32G, 34G, or 36G, etc.) to ensure delivery of the injectant while minimizing the diameter of the needle tract formed by the needle insertion. In addition, the aspect ratio of the needle lumen and the tip bevel of the hollow puncture needle 6 are the same as or different from the standard 27G and 30G needles generally used for intraocular injection.

In some embodiments, a therapeutic agent (e.g., a drug) may be added to the injectate within the injectate-containing zone 7. Non-limiting examples of specific drugs and classes of drugs include beta-adrenoceptor antagonists (e.g., carteolol, cetomar, betaxolol, levobunolol, naproxol, ti Mo Luoer), mimetics (e.g., pilocarpine, carbachol, physostigmine), sympathomimetics (e.g., epinephrine, infiltrant), carbonic anhydrase inhibitors (e.g., acetazolamide, dorzolamide), topoisomerase inhibitors (e.g., topotecan, irinotecan, camptothecin, lamellarin D, etoposide, teniposide, doxorubicin, mitoxantrone, amacrine), prostaglandins, antimicrobial compounds, antifungal agents (e.g., chloramphenicol, chlortetracycline, ciprofloxacin, aspergillin, fusidic acid, gentamicin, neomycin, norfloxacin, ofloxacin, polymyxin, tetracycline, tobramycin, quinoline), antiviral compounds (e.g., acyclovir, ciprofloxacin Wei Duo), aldose reductase inhibitors, anti-inflammatory and/or anti-allergic compounds (e.g., steroids, such as betamethasone, clobetasone, dexamethasone, lometolone, hydrocortisone, prednisolone, and non-steroids (e.g., oxazoline, bromfenac, diclofenac, indomethacin, lodoxamide, sha Pufen, cromolyn sodium), artificial tear/dry eye therapeutic agents, local anesthetics (e.g., methoxycarbonyl, lidocaine, oxybuprocaine, ciprofloxacin), diclofenac, uracil ketones, and growth factors (e.g., epidermal growth factor, mydriatic and cycloplegic drugs, mitomycin C and collagenase inhibitors) and age-related macular degeneration therapeutic agents (e.g., sodium alginate, tobrambutazine, and mucor, and clobetasol, and its derivatives, and their salts, ranibizumab, af Bai Xibu, bevacizumab).

In some embodiments, the therapeutic agent can be an integrin antagonist, a selectin antagonist, an adhesion molecule antagonist (e.g., intercellular adhesion molecule (ICAM) -1, ICAM-2, ICAM-3, platelet endothelial adhesion molecule (PCAM), vascular Cell Adhesion Molecule (VCAM), a cytokine or growth factor antagonist that induces leukocyte adhesion (e.g., tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1 beta), monocyte chemoattractant protein-1 (MCP-1), vascular Endothelial Growth Factor (VEGF)).

In some embodiments, both drugs may be delivered by the methods described previously. The two drugs can be administered in the form of a composition preparation or sequentially in the form of two separate preparations. For example, VEGF inhibitors and VEGF are provided. The VEGF inhibitor may be an antibody, such as a humanized monoclonal antibody, bevacizumab, ranibizumab, or aflibercept or pegaptanib.

In some embodiments, the medical puncturing devices of the invention may be used to deliver one or more VEGF antagonists including AL8326, 2C3 antibodies, AT001 antibodies, hyBEV, bevacizumab (Avastin), ANG3070, APX003 antibodies, APX004 antibodies, ponatinib (AP 2457), BDM-E, VGX antibodies (VGX 100 CIRCADIAN), VGX200 (C-fos induced growth factor monoclonal antibodies), VGX300, cosix, DLX903/1008 antibodies, ENMD2076, sutent (sunitinib malate), INDUS815C, R antibody, KD019, NM3, allogeneic mesenchymal precursor cells with anti-VEGF agents or antibodies, MGCD265, MG516, VEGF-receptor kinase inhibitors, 026mp 0, NT503, anti-DLL 4/VEGF specific antibodies, PAN90806, palloxft 42615, paxl 080 615, watft 4246, watzn 4264, AAV 4251, zantinib (AAV) and AAV 4251, AAV 4264, KRN-951), strivacaib (regorafenib), walasetinib (BI 6727), CEP11981, KH903, lenvatinib (E7080), terameprocol (EM 1421), raney mAb (Lucentis), votrient (Pazopanib hydrochloride), PF00337210, PRS050, SP01 (curcumin), carboxyamidotriazole orotate, hydroxychloroquine, rinefanib (ABT 869, RG 3635), I Lu Wen (fluocinone), ALG1001, AGN150998, DARPin MP0112, AVAAP (101), AMGAP (101), TKAAP (351)), BMS690514, 902 KH, golvatinib (E7050), afinitor (everolimus), davintinib (AVI 258, CHIR 258), ORA101, ORA102, axitinib (Inlyta, AG 013736), pridin (Aplidin), lenvatinib mesylate, PTC299, aflebbeccept), pegaptanib sodium (Macugen, LI 900015), visudyne (verteporfin), bucillamine (Rimatil, lamin, brimani, lamit, boomiq), R3 antibody, AT001/R84 antibody, troponin (BLS 0597), EG3306, watalanib (PTK 787), bmab100, GSK2136773, anti-VEGFR substituase, avela, CEP7055, CLT009, ESBA903, huMax-VEGF antibody, GW654652, HMPL010, GEM220, HYB676, JNJ17029259, TAK593, xtendVEGF antibody, nova21012, nova21013, CP564959, intelligent anti-VEGF antibody, AG028262, AG13958, CVX241, SU14813, PRS055, PG501, PG545, PT1101, TG100948, I CS283, XL647, enzastatin hydrochloride (LY 3264 zxft 64), BC194, quinoline, COT601M06.1, COT604M06.2, mabionVEGF, SIR Spheres coupled to anti-VEGF or VEGF-R antibody, apatinib 32968D 3818 and AL3818.

In addition, a VEGF inhibitor or VEGF antagonist may be combined with one or more of the agents listed herein or with other agents known in the art.

The medical puncturing device and medical instrument assembly of the present invention may also be used for the treatment of glaucoma.

Glaucoma is an eye disease affecting millions of people and its etiology is associated with elevated intraocular pressure due to the inability of the ocular drainage system to adequately drain aqueous humor from the anterior chamber or excessive production of aqueous humor by the ciliary body. The accumulation of aqueous humor and the resulting increase in intraocular pressure can lead to irreversible damage to the optic nerve and retina, and in severe cases, even blindness.

Specifically, glaucoma is of two main types, open angle and closed angle. Open angle glaucoma refers to the type of glaucoma in which the intraocular pressure is elevated but the anterior chamber angle (drainage angle) remains open, with a common cause being trabecular meshwork obstruction. Closed angle glaucoma, on the other hand, refers to the type of glaucoma in which the pressure in the eye is elevated due to partial or complete closure of the angle of the anterior chamber, in which the iris swells, sticks to, or moves forward to close the angle of the anterior chamber and prevent fluid from entering the trabecular meshwork, thereby impeding the flow of aqueous humor out of the eye.

Currently, glaucoma can be treated surgically, and the treatment involves placing a drainage device in the eye to create an aqueous drainage (e.g., subconjunctival drainage, schlemm's canal drainage, and suprachoroidal drainage) pathway between the various structures of the anterior chamber and the eye. The surgical operation for implanting the drainage device can be to insert the delivery device for placing the drainage device into a specific part of the eye and then implant the drainage device.

In some prior treatments, a delivery device for placement of a drainage device may be passed through the cornea into the eye (endoleak), passed in the anterior chamber and extended into the contralateral angle until the anterior portion of the delivery device is proximal to the outflow site of aqueous humor, and the drainage device is placed to form an aqueous humor drainage pathway between the anterior chamber and the outflow site of aqueous humor. While in other prior art methods of treatment, delivery devices for holding drainage devices have used an external puncture method into the eye that involves the step of insertion through the sclera.

However, the current surgical method of the suprachoroidal aqueous humor drainage device implanted from the external route requires full-layer sclera incision, the wound is large, the surgical time is long, and the surgical method of the suprachoroidal aqueous humor drainage device implanted from the internal route cannot accurately control the puncture depth, and is easy to puncture excessively to damage other eye tissues or cannot implant normally due to insufficient puncture depth. In addition, the surgical methods for external and internal implantation of the subconjunctival space also have the problem that the penetration depth cannot be accurately controlled. It follows that there is still considerable room for improvement in current surgical methods of treating the choroidal and subconjunctival aqueous humor drainage devices of glaucoma.

To address at least one of the deficiencies or shortcomings of current devices and surgical methods for treating glaucoma, the present invention may employ a medical puncturing device or medical instrument assembly as described above for glaucoma treatment. Specifically, drainage of aqueous humor from the anterior chamber is facilitated by targeting the suprachoroidal and/or subconjunctival space for aqueous outflow, or by performing an access, dilation, or instrument implantation (e.g., implantation of a drainage device) between the targeted outflow and inflow regions (e.g., the anterior chamber).

There is first provided a method for implanting a drainage device in an eye, the method comprising: (a) Inserting a needle into the eye to form a delivery channel in the eye, wherein the delivery channel terminates at a target aqueous humor outflow region in the eye; (b) Delivering fluid through the needle to form an enlarged space at the target outflow region; (c) Positioning an inflow end of a drainage device in the anterior chamber and an outflow end of the drainage device in the enlarged space, wherein the drainage device is releasably connected to the needle; and (d) releasing the needle from the drainage device, thereby implanting the drainage device in the eye to establish fluid communication between the anterior chamber and the target outflow region.

In some embodiments, the needle is caused to pierce the sclera. Optionally, the method comprises performing a conjunctival incision prior to the needle piercing the sclera. Optionally, the needle is pierced through the conjunctiva and sclera, and the above method does not include making an incision in the conjunctiva. Optionally, the target outflow region is between the sclera and the choroid, and the enlarged space is the suprachoroidal space. Optionally, the positioning step includes positioning the forward end of the needle in the suprachoroidal space and toward the anterior chamber angle.

In some embodiments, the drainage device is disposed within the needle. Alternatively, the drainage device is arranged in the needle lumen of the needle, or the drainage device is formed as a cannula which is sleeved over the needle.

In some embodiments, the positioning step comprises advancing the drainage device from within the needle lumen to the forward end of the needle or advancing a drainage device over the needle to the forward end of the needle. Optionally, advancing comprises pushing the drainage device into the needle lumen or over the needle using a guidewire. Optionally, the positioning step comprises piercing the anterior chamber angle with a needle and/or a leading end of a drainage device. Optionally, the releasing step comprises removing the needle and/or guidewire from the eye, leaving the inflow end of the drainage device in the anterior chamber and the outflow end of the drainage device in the suprachoroidal space.

In some embodiments, the drainage device is connected to the needle before or after the inserting step. Optionally, the drainage device is connected to the needle before or after delivery of the fluid. Optionally, the drainage device is releasably connected to the forward end of the needle.

In some embodiments, the positioning step comprises positioning the drainage device toward the anterior chamber angle. Optionally, the positioning step includes advancing a needle to pierce the anterior chamber angle with the leading end of the drainage device. Optionally, the releasing step comprises removing the needle, leaving the inflow end of the drainage device in the anterior chamber and the outflow end of the drainage device in the suprachoroidal space.

In some embodiments, the positioning step includes positioning the forward end of the needle in the suprachoroidal space and away from the anterior chamber angle. Alternatively, the drainage device is arranged in the needle, wherein the drainage device is arranged in the needle cavity of the needle, or the drainage device is formed as a sleeve which is arranged over the needle. Optionally, the positioning step comprises advancing the drainage device from within the needle lumen to the forward end of the needle or advancing a drainage device sheathed over the needle to the forward end of the needle. Optionally, advancing comprises pushing the drainage device into the needle lumen or over the needle using a guidewire. Optionally, the positioning step comprises positioning the outflow end of the drainage device in the suprachoroidal space and away from the anterior chamber angle. Optionally, the positioning step comprises removing the needle from the eye, leaving the outflow end of the drainage device in the suprachoroidal space.

In some embodiments, the method further comprises piercing the anterior chamber angle to form the implant channel. Optionally, an inflow end of the drainage device is positioned through an implant channel in the anterior chamber. Alternatively, the implant channels may be formed using the same needle or different piercing elements. Alternatively, the same needle or different piercing elements may be used to pierce the conjunctiva, sclera, suprachoroidal space, and anterior chamber angle. Alternatively, the needle may be inserted into the eye at a first access point, and the same needle or a different piercing element may be inserted into the eye at a second access point different from the first access point to form the implant channel.

In some embodiments, the outflow end of the drainage device includes a portion between the first and second entry points located outside the sclera. Optionally, the outflow end of the drainage device comprises a portion located between the first and second entry points on the outer side of the sclera and conjunctiva. Optionally, the portion outside the sclera is under the conjunctiva. Optionally, the method includes incising the conjunctiva to expose the sclera, and suturing the conjunctiva to cover a portion of the drainage device outside the sclera after positioning the inflow end of the drainage device through the implant channel in the anterior chamber. Optionally, the portion of the drainage device outside the sclera comprises a drainage device diversion port, wherein the drainage device diversion port may be located subconjunctivally.

In some embodiments, the above methods comprise placing an antimetabolite under the opened conjunctiva.

In some embodiments, the needle is inserted into the eye from an external or internal route.

In some embodiments, the target outflow region is between the conjunctiva and the sclera, and the enlarged space is the subconjunctival space. Optionally, the drainage device is disposed within the needle lumen. Alternatively, the drainage device is formed as a cannula which is placed over the needle, or the drainage device is releasably attached to the forward end of the needle.

In some embodiments, there is provided another method for implanting a drainage device in an eye, the method comprising: (a) Inserting a needle into the eye to form a delivery channel within the eye, wherein the delivery channel terminates between the sclera and the choroid; (b) delivering fluid through the needle to form the suprachoroidal space; (c) Penetrating the anterior chamber angle with the leading end of the needle and/or a drainage device releasably attached to the needle; (d) Placing a drainage device through the angle of the anterior chamber, so that the inflow end of the drainage device is positioned in the anterior chamber and the outflow end of the drainage device is positioned in the suprachoroidal space; and (e) removing the needle from the eye, thereby implanting the drainage device in the eye to allow communication between the anterior chamber and the suprachoroidal space.

In some embodiments, there is provided another method for implanting a drainage device in an eye, the method comprising: (a) Inserting a needle into the eye to form a delivery channel within the eye, wherein the delivery channel terminates between the sclera and the choroid; (b) delivering fluid through the needle to form the suprachoroidal space; (c) Placing the outflow end of the drainage device with a needle within the suprachoroidal space and away from the anterior chamber angle; (d) penetrating the anterior chamber angle to form an implant channel; (e) The inflow end of the drainage device is positioned in the anterior chamber through the implant channel, placing the drainage device in the eye to allow communication between the anterior chamber and the suprachoroidal space.

In some embodiments, a portion of the drainage device is located outside the sclera. Optionally, the portion of episcleral drainage is located subconjunctivally. Alternatively, a portion of the drainage device may be located outside of the sclera and conjunctiva. Optionally, the drainage device comprises a drainage device diversion port located in the sclera and outside the conjunctiva and/or a drainage device diversion port located outside the conjunctiva. Optionally, the drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space. Optionally, the drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the extraconjunctival space.

In some embodiments, a method for implanting a drainage device from an internal pathway into an eye is provided, the method comprising: (a) Passing the needle and/or a drainage device releasably attached to the needle sequentially through the cornea and anterior chamber to the suprachoroidal or subconjunctival space; (b) Delivering fluid to the suprachoroidal or subconjunctival space through a needle and/or drainage device; (c) Placing the inflow end of the drainage device into the anterior chamber, and placing the outflow end of the drainage device into the suprachoroidal space or the subconjunctival space; and (d) removing the needle from the eye, thereby implanting the drainage device in the eye to provide fluid communication between the anterior chamber and the suprachoroidal or subconjunctival space.

In some embodiments, the drainage device contains a drug or biological agent.

In some embodiments, the drainage device is configured to be advanced forward or along the needle and exposed at the leading end of the needle when the needle reaches the target outflow region.

In some embodiments, the drainage device is an intraocular drainage device disposed within the needle.

Referring to fig. 23-29, a method for implanting a drainage device in an eye will now be described in detail. A needle is first inserted into the eye through the conjunctiva and sclera to form a delivery channel within the eye, wherein the delivery channel terminates between the sclera and the choroid. A fluid, such as one having viscoelastic properties, is delivered through the needle to form the suprachoroidal space between the sclera and the choroid. The needle is then rotated to position the forward end of the needle toward the angle of the anterior chamber, as the suprachoroidal space has been enlarged by the viscoelastic fluid, thus allowing more room for adjustment of the orientation of the forward end of the needle without causing damage to the choroid or other surrounding ocular tissue. Next, the needle is moved so that the forward end of the needle pierces the angle of the anterior chamber, thereby exposing the forward end opening of the needle to the anterior chamber. The drainage device may then be inserted into the needle (or it may be pre-inserted into the needle before inserting the needle and injecting the fluid) and moved to protrude from the front end opening of the needle. Thus, the drainage device can be positioned through the angle of the anterior chamber such that the inflow end of the drainage device is placed into the anterior chamber and the outflow end of the drainage device is placed into the suprachoroidal space. After placement of the drainage device, the needle is removed from the eye, leaving the drainage device in the eye to provide fluid communication between the anterior chamber and the suprachoroidal space.

It can be seen that the method of the illustrated embodiment described above is a minimally invasive method that does not require the sclera to be surgically dissected entirely, or the sclera and choroid to be surgically separated, or the dissected sclera or conjunctiva to be sutured post-operatively. Therefore, the minimally invasive method can reduce the damage of eye tissues, reduce the requirements on surgical techniques and save the operation time.

Referring to fig. 30-36, or 37-42, another method for implanting a drainage device in an eye will now be described in detail. A needle is first inserted into the eye through the conjunctiva and sclera to form a delivery channel within the eye, wherein the delivery channel terminates between the sclera and the choroid. A fluid, such as one having viscoelastic properties, is delivered through the needle to form the suprachoroidal space between the sclera and the choroid. The needle is then rotated such that the forward end of the needle is positioned away from the anterior chamber angle. Since the suprachoroidal space has been enlarged by the fluid, there is more room to adjust the orientation of the forward end of the needle without causing damage to the choroid or other surrounding ocular tissues. Next, the drainage device is inserted into the needle (or it may be pre-inserted into the needle before inserting the needle and injecting the fluid) and placed at the front end of the needle, and the needle is then removed so that the outflow end of the drainage device is located away from the anterior chamber angle and the other end is located outside the sclera. Further, the same or a different needle (not necessarily hollow) is used to pierce the sclera and pass through the suprachoroidal space and the anterior chamber angle to form the implant channel. The other end of the drainage device is then inserted into the implant passage to place the inflow end of the drainage device in the anterior chamber, thereby implanting the drainage device in the eye to provide fluid communication between the anterior chamber and the suprachoroidal space.

In the methods of the illustrated embodiments, a portion of the drainage device is placed outside the sclera, such as under the conjunctiva or outside the conjunctiva. Further, the portion of the drainage device that is placed outside the sclera can be formed with a drainage device shunt port such that the drainage device can provide fluid communication between both the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space, or can provide fluid communication between both the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space, achieving a dual drainage effect.

It should be noted that the inflow end, outflow end, and/or shunt port of the drainage device may include one or more valves, such as one-way valves, for example, to control the flow of fluid only in one direction from the anterior chamber. For example, the fluid flow can be controlled such that fluid can only flow from the anterior chamber to the drainage device outflow end (i.e., to the suprachoroidal space or subconjunctival space, for example) and/or the drainage device shunt port (i.e., to the subconjunctival space or subconjunctival space, for example), without flowing back into the anterior chamber from the drainage device outflow end or the drainage device shunt port, thereby ensuring that the drainage device achieves an intraocular pressure-reducing effect.

Referring to fig. 43 to 45, a method of using the medical puncturing device (or medical instrument assembly) of the present invention to implant a drainage device from an internal path into an eye will now be described in detail. A hollow piercing needle of a medical puncturing device is first inserted through the cornea and the anterior chamber into the subconjunctival space (or the suprachoroidal space). Fluid, such as fluid having viscoelastic properties, enters the subconjunctival space through the hollow piercing needle, thereby dilating the subconjunctival space. The drainage device is then implanted through the hollow puncture needle to place the outflow end of the drainage device in the subconjunctival space, and after withdrawal of the hollow puncture needle, the inflow end of the drainage device is placed in the anterior chamber to provide fluid communication between the anterior chamber and the subconjunctival space.

Compared with the existing internal implantation surgery method, the method of the illustrated embodiment can accurately control the injection and expansion of the subconjunctival cavity, thereby effectively reducing or avoiding the risk of puncture of the conjunctiva by the hollow puncture needle.

To adapt the medical puncturing device and medical instrument assembly of the present invention for use in the injection, access, expansion or implantation of superficial or potential interstitial spaces, systems, vessels of the eye, particularly for use in the treatment of the suprachoroidal space and glaucoma, in conjunction with the foregoing embodiments, the medical puncturing device may be further formed as an eye puncturing device and the medical instrument assembly may be further formed as an eye implant instrument assembly.

The following will supplementally describe some features of the ocular piercing device which are different from the medical piercing device having versatility of the present invention, and supplementally describe some features of the ocular implant assembly which are different from the medical instrument assembly having versatility of the present invention. And in the present invention, all of the foregoing embodiments of the medical puncturing device and medical instrument assembly having versatility can be applied to the eye puncturing device and the eye implantation instrument assembly.

For the eye puncturing device, the injection containing region 7 of which is pre-stored with an eye injection suitable for eye injection, reference is made to the aforementioned listed injection types, including an eye therapeutic agent for treating eye diseases (e.g., glaucoma, suprachoroidal or subconjunctival diseases), or a settable eye injection capable of being set after injection and enlargement of the prominent or underlying interstitial spaces, luminal systems, vessels (e.g., suprachoroidal and subconjunctival spaces) of the eye.

For the eye puncture, the hollow puncture needle 6 can adopt the specification of 30G to 23G

The implant 11 suitable for ocular implantation is an ocular implant, and as known from the aforementioned ocular surgical methods, the ocular implant can be roughly classified into three types according to the difference in the installation and implantation methods of the ocular implant. Wherein the first type of ocular implant is pre-installed in the needle lumen of the hollow puncture needle 6 and can be advanced to be released from the front needle hole 6 a. The second type of ocular implant is sleeved outside the hollow puncture needle 6 and can be advanced to be released from the front end of the hollow puncture needle 6. A third type of ocular implant is releasably attached to the forward end of the hollow piercing needle 6.

Further, the first, second, and third types of ocular implants may each include a drainage device as described above as being suitable for glaucoma drainage therapy.

When applied to suprachoroidal puncture, the eye piercing means comprises a sclera puncture condition after the hollow puncture needle 6 has punctured the forward closed end of the barrel, in which sclera puncture condition the hollow puncture needle 6 extends from the forward closed end of the barrel over a length in the range of the sclera puncture length over which the peripheral wall needle aperture 6b is preferably at least partially in communication with the injection containment zone 7.

When applied to suprachoroidal puncture, the eye puncture apparatus further comprises a suprachoroidal flow guiding state after the hollow puncture needle 6 punctures the front closed end of the cylinder, in the suprachoroidal flow guiding state, the length range of the hollow puncture needle 6 protruding from the front closed end of the cylinder is the suprachoroidal flow guiding length range, and in the suprachoroidal flow guiding length range, preferably, the peripheral wall needle hole 6b is located in the injection holding region 7.

When applied to subconjunctival puncture, the eye puncture device comprises a subconjunctival diversion state after the hollow puncture needle 6 punctures the front closed end of the needle cylinder, in the subconjunctival diversion state, the length range of the hollow puncture needle 6 extending out of the front closed end of the needle cylinder is the subconjunctival diversion length range, and in the subconjunctival diversion length range, the peripheral wall needle hole 6b is preferably positioned in the injection accommodating area 7.

For ocular implant instrument assemblies, the ocular penetration device, auxiliary guide needle 12 and ocular implant included therein may be provided pre-assembled or non-pre-assembled. When in use, the eye puncture device injects eye injection into the tissue gaps, cavity systems and vessels of the eye to enlarge the tissue gaps, cavity systems and vessels, then the eye implant is led into the needle cavity of the hollow puncture needle 6 through the needle cavity of the auxiliary guide needle 12 and the implant guide structure of the eye puncture device, and finally the eye implant extends out of the front needle hole 6a to be implanted into the tissue gaps, cavity systems and vessels which are enlarged.

Typically, ocular implants are in the form of filaments or tubes. For example, the aforementioned drainage device suitable for glaucoma drainage therapy may be provided in a tubular shape.

As is known from the foregoing glaucoma treatment methods, by employing an ocular implant device assembly, the outflow end of the drainage device can be placed in the suprachoroidal space and the inflow end of the drainage device can be placed in the anterior chamber, thereby providing fluid communication between the suprachoroidal space and the anterior chamber. Alternatively, the outflow end of the drainage device can be placed in the subconjunctival space and the inflow end of the drainage device can be placed in the anterior chamber, thereby providing fluid communication between the subconjunctival space and the anterior chamber. Still alternatively, the drainage device is provided with a drainage device shunt port located between the inflow end and the outflow end of the drainage device, the inflow end of the drainage device can be placed in the anterior chamber and the outflow end of the drainage device can be placed in the suprachoroidal space and the drainage device shunt port can be placed outside the sclera (e.g., subconjunctival space or subconjunctival space) by employing the ocular implant device assembly to achieve a dual drainage effect.

In order to adjust the orientation of the outflow end of the drainage device, a flexible drainage catheter capable of being flexibly bent is preferably used as the drainage device, and the flexible drainage catheter is particularly suitable for a double-drainage treatment method in combination with the method.

Although the embodiments of the present invention have been described in detail with reference to the accompanying drawings, the embodiments of the present invention are not limited to the details of the above embodiments, and various simple modifications can be made to the technical solutions of the embodiments of the present invention within the technical idea of the embodiments of the present invention, and the simple modifications all belong to the protection scope of the embodiments of the present invention.

It should be noted that, in the foregoing embodiments, various features described in the foregoing embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, various possible combinations are not described in further detail in the embodiments of the present invention.

In addition, any combination of various different implementation manners of the embodiments of the present invention is also possible, and the embodiments of the present invention should be considered as disclosed in the embodiments of the present invention as long as the combination does not depart from the spirit of the embodiments of the present invention.

Claims

1. The eye puncture device is characterized by comprising a needle cylinder (1), an elastic pushing assembly, a hollow puncture needle (6), at least one injection accommodating area (7) and an eye injection suitable for eye injection, wherein the needle cylinder (1) comprises a front closed end and a rear open end of the needle cylinder, the elastic pushing assembly comprises a pressing part (2) and a pierceable movable sealing part (3) which is positioned in an inner cavity of the needle cylinder and can be elastically connected with the pressing part (2) in a front-back manner, the hollow puncture needle (6) is fixedly connected to the pressing part (2) and is provided with a front end needle hole (6 a) and a peripheral wall needle hole (6 b), the injection accommodating area (7) is formed in an inner cavity area of the needle cylinder which is surrounded by the front closed end of the needle cylinder, the peripheral wall of the inner cavity of the needle cylinder and the movable sealing part (3), and the eye injection is stored in the injection accommodating area (7) in advance; the eye puncture device is arranged to push the hollow puncture needle (6) forwards to puncture the front closed end of the needle cylinder by pressing the pressing part (2), so that the eye injection can flow out from the injection accommodating area (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) which are communicated in sequence.

2. The eye puncturing device of claim 1, wherein the eye injection comprises an eye treatment for treating an eye disease; and/or, the ocular injection comprises a settable ocular injection capable of setting after injection and expansion of the apparent or underlying interstitial space, cavity system, vasculature of the eye.

3. The eye puncturing device according to claim 1, wherein the hollow puncturing needle (6) has a gauge of 30G to 23G.

4. The eye puncturing device according to claim 1, comprising a first type of eye implant pre-mounted in the needle lumen of the hollow puncturing needle (6) and advanceable to release from the front needle aperture (6 a);

and/or the eye puncture device comprises a second type of eye implant which is sleeved outside the hollow puncture needle (6) and can advance to be released from the front end of the hollow puncture needle (6);

and/or the eye piercing device comprises a third type of eye implant releasably connected to the front end of the hollow piercing needle (6).

5. The ocular penetration device of claim 4, wherein the first, second and third types of ocular implants each comprise a drainage device suitable for glaucoma drainage therapy.

6. The eye puncture device according to claim 1, wherein the eye puncture device comprises a sclera puncture state after the hollow puncture needle (6) punctures the front closed end of the needle cylinder, in the sclera puncture state, the hollow puncture needle (6) extends out of the front closed end of the needle cylinder in a sclera puncture length range, and in the sclera puncture length range, the peripheral wall needle hole (6 b) is at least partially communicated with the injection accommodation area (7).

7. The eye puncture device according to claim 1, wherein the eye puncture device comprises a suprachoroidal flow guiding state after the hollow puncture needle (6) punctures the front closed end of the cylinder, in which the hollow puncture needle (6) protrudes from the front closed end of the cylinder in a length range of a suprachoroidal flow guiding length, in which the peripheral wall needle hole (6 b) is located in the injection accommodation region (7).

8. The eye puncture device according to claim 1, wherein the eye puncture device comprises a subconjunctival diversion state after the hollow puncture needle (6) punctures the front closed end of the cylinder, in the subconjunctival diversion state, a length range of the hollow puncture needle (6) protruding from the front closed end of the cylinder is a subconjunctival diversion length range, and in the subconjunctival diversion length range, the peripheral wall needle hole (6 b) is located in the injection-containing region (7).

9. The eye puncturing device according to claim 1, wherein the peripheral wall needle hole (6 b) is maintained above the injection agent accommodating area (7) before the hollow puncturing needle (6) protrudes from the front closed end of the cylinder.

10. The eye puncturing device according to claim 1, characterized by comprising a flow guiding state in which the injection accommodating section (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) are communicated, wherein the movable sealing part (3) can move forward to block the peripheral wall needle hole (6 b) by a resilient force between the movable sealing part and the pressing part (2).

11. The eye puncturing device according to claim 10, wherein in the flow guiding state, the movable sealing part (3) blocks the peripheral wall needle hole (6 b) when moving forward to abut against the front closed end of the needle cylinder.

12. The eye puncturing device according to claim 1, wherein an axial stopper (1 a) is provided in the needle cylinder chamber in front of the movable seal (3) for stopping the movable seal (3) from moving forward, and the eye puncturing device comprises a flow guiding state in which the injection storage region (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) are communicated, and in the flow guiding state, the peripheral wall needle hole (6 b) is in front of the axial stopper (1 a), and the movable seal (3) can move forward by a resilient force between the movable seal and the pressing portion (2).

13. The eye puncturing device according to claim 1, wherein the eye puncturing device comprises a manual control part connected to the movable sealing part (3) and partly protruding out of the syringe.

14. The eye puncturing device according to claim 13, wherein the movable sealing portion (3) and the manual control portion form a front and rear elastic connection.

15. The eye puncture device according to claim 14, wherein the needle cylinder (1) is formed with a needle cylinder peripheral wall sliding groove extending in the axial direction at a peripheral wall portion located behind the movable seal portion (3), the manual control portion includes a pressure control slider slidably engaged with the needle cylinder peripheral wall sliding groove, and the movable seal portion (3) and the pressure control slider are elastically connected in the front-rear direction.

16. The eye puncturing device according to claim 1, wherein the eye puncturing device comprises at least one axially slidable pierceable isolating seal (13) disposed in a syringe cavity region between the movable seal (3) and the front closed end of the syringe, and the injection agent accommodating region (7) is formed with a plurality of axially isolatable seals (13).

17. The eye puncturing device according to claim 1, further comprising an implant guide for introducing an eye implant into the needle lumen of the hollow puncturing needle (6).

18. The eye puncturing device according to claim 17, wherein the implant guide structure comprises an inclined guide groove (3 a) formed on the movable sealing portion (3) and extending obliquely toward the hollow puncturing needle (6).

19. The ocular piercing device of claim 18, wherein the inclined guide groove (3 a) is formed through in the front-rear direction, and the implant guide structure further comprises a one-way flap assembly (9) which is inserted into the inclined guide groove (3 a) and is openable and closable or a guide groove seal member which is inserted into the inclined guide groove (3 a).

20. The eye puncturing device according to claim 18, wherein the inclined guide groove (3 a) is formed in an upper surface of the movable sealing portion (3) and is a non-through groove.

21. The eye puncturing device according to claim 18, wherein the peripheral wall needle hole (6 b) is formed as an inclined hole opening obliquely rearward.

22. The eye puncturing device according to claim 17, wherein the implant guide structure comprises an inclined guide needle hole (6 c) formed in a peripheral wall of the hollow puncturing needle (6) and opened obliquely rearward, the eye puncturing device comprising a flow guiding state in which the injection agent housing section (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) are communicated, the inclined guide needle hole (6 c) being located rearward of the movable sealing portion (3) in the flow guiding state.

23. The ocular piercing device of claim 22, wherein the implant guide structure further comprises an openable and closable one-way valve assembly (9) inserted into the inclined guide needle aperture (6 c) or a needle aperture seal (10) inserted into the inclined guide needle aperture (6 c).

24. The eye puncturing device according to claim 17, wherein the implant guide structure comprises a center guide groove (2 c) formed at a center position of a rear end surface of the pressing portion (2) and adapted to be pierced, and the hollow puncturing needle (6) is formed with a rear end needle hole axially aligned with the center guide groove (2 c).

25. The eye puncturing device of any one of claims 1 through 24, wherein the eye puncturing device comprises a puncturing control module and a fluid storage module that are formed separately from each other;

wherein the puncture control module comprises a first syringe unit, and the elastic pushing component and the hollow puncture needle (6) which are arranged in a syringe cavity of the first syringe unit;

the fluid storage module comprising a second syringe unit, the injection receiving area (7) formed within a barrel cavity of the second syringe unit, and a module enclosure removably enclosed at a rear end of the second syringe unit;

26. The eye puncturing device of any one of claims 1 through 24, wherein the eye puncturing device comprises a puncturing control module and a fluid storage module that are formed separately from each other;

wherein the puncture control module comprises a first syringe unit, and the pressing part (2) and the hollow puncture needle (6) which are arranged in the syringe cavity of the first syringe unit;

the fluid storage module comprising a second syringe unit, the injection receiving area (7) formed within a barrel cavity of the second syringe unit, and the movable seal (3) encapsulated at a rear end of the second syringe unit;

27. The eye puncturing device of any one of claims 1 through 24, wherein the eye puncturing device comprises a puncturing control module, a transition connection module, and a fluid storage module that are formed separately from one another;

the transition connection module comprises a second syringe unit and the movable sealing part (3) arranged in a barrel cavity of the second syringe unit;

the fluid storage module comprises a third syringe unit, the injection receiving area (7) formed within a barrel cavity of the third syringe unit, and a module enclosure removably enclosed at a rear end of the third syringe unit;

28. An ocular implant device assembly, comprising an ocular implant and an ocular penetration device according to any of claims 17 to 24.