CN112451207B - Surgical instrument assembly for implanting a retinal implant - Google Patents

Surgical instrument assembly for implanting a retinal implant Download PDF

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Publication number
CN112451207B
CN112451207B CN202011439339.3A CN202011439339A CN112451207B CN 112451207 B CN112451207 B CN 112451207B CN 202011439339 A CN202011439339 A CN 202011439339A CN 112451207 B CN112451207 B CN 112451207B
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flexible electrode
surgical instrument
implanting
instrument assembly
guide head
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CN112451207A (en
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戴聿昌
庞长林
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Intellimicro Medical Co ltd
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Intellimicro Medical Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0543Retinal electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye

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

Abstract

The invention discloses an ophthalmologic surgical instrument for implanting a flexible electrode, which comprises a holding part and a flexible electrode guiding head, wherein: one end of the flexible electrode guide head is connected with the holding part, the flexible electrode guide head comprises a bottom part and two bending parts, and the bottom part is provided with a top surface and a bottom surface; the two bending parts are connected to two sides of the bottom part, are positioned on one side of the top surface and bend towards directions close to each other; and a space for accommodating the flexible electrode is formed between the two bending parts and the bottom. The invention can curl the electrode array of the flexible electrode in the two bending parts and reduce the whole width of the electrode array, thereby ensuring that the surgical incision on the eyeball is smaller and reducing the surgical risk; in addition, the flexible electrode can be protected from external force when passing through an incision on the eyeball. The invention has convenient operation, reduces the operation difficulty and shortens the operation time.

Description

Surgical instrument assembly for implanting a retinal implant
Technical Field
The invention relates to the technical field of medical instruments, in particular to a surgical instrument assembly for implanting a retina implant.
Background
The visual prosthesis is an implanted medical appliance for helping a patient with pathological changes of retina or other visual organs to regain brightness and vision. Normal vision is developed by light-sensitive cells on the retina (e.g., cones and rods) converting light stimuli into electrical signals that, after being encoded by various layers of cells of the retina (e.g., horizontal cells, bipolar cells, ganglion cells, etc.), transmit nerve impulses to the visual cortex.
One currently used visual prosthesis design is to implant a microelectrode implant on the surface of the retina to help patients with outer retinal degenerative diseases such as retinitis pigmentosa and age-related macular degeneration. The visual prosthesis includes two portions, an implant and an outer member. The electronic packaging body in the implant is sewed outside the sclera of the eyeball, the flexible electrode penetrates through the wall of the eyeball, and the electrode array at the end part of the flexible electrode is fixed on the surface of the retina through a fixing nail. The external part comprises a camera for collecting video information, the video information is wirelessly transmitted to an electronic packaging body of the implant after data conversion, the electrode array transmits stimulation to the retina in an electric stimulation mode, electric pulse signals transmitted to the retina stimulate neurons still with functions on the retina, and the stimulation is transmitted to the brain through the optic nerve to enable a patient to generate visual perception.
In the related art, during the implantation process, the flexible electrode of the implant needs to form an incision on the sclera of the eyeball, and then the flexible electrode is held by forceps and extends into the incision. However, since the flexible electrode is generally flexible relative to the slit-shaped incision of the sclera, it is difficult to pass the flexible electrode through the slit and the flexible electrode is easily torn and broken due to the excessive force. In addition, for the high-channel electrode array, the width of the flexible electrode is generally larger, so that the surgical incision is correspondingly enlarged, and the surgical risk is increased.
Disclosure of Invention
The present invention is directed to solving at least one of the problems of the prior art. To this end, it is an object of the present invention to provide a surgical instrument assembly for implanting a retinal implant which reduces the width of a surgical incision, reduces surgical risks, protects flexible electrodes, and enables the entire surgical procedure to be simple, convenient for a surgeon to operate, and less time consuming.
A surgical instrument assembly for implanting a retinal implant according to an embodiment of the present invention, the retinal implant including an electronics package and a flexible electrode, the surgical instrument assembly including an ophthalmic surgical instrument and a surgical tool, the ophthalmic surgical instrument including a grip and a flexible electrode lead, wherein: one end of the flexible electrode guide head is connected with the holding part, the flexible electrode guide head comprises a bottom part and two bending parts, and the bottom part is provided with a top surface and a bottom surface; the two bending parts are connected to two sides of the bottom part, are positioned on one side of the top surface and bend towards directions close to each other; a space for accommodating the flexible electrode is formed between the two bending parts and the bottom; when the retina implant is implanted into an eyeball, the electronic packaging body is sewn on the outer surface of the eyeball, the flexible electrode guide head accommodating the electrode array of the flexible electrode is suitable for passing through an incision of the eyeball, the surgical tool is inserted into another position of the eyeball, and the electrode array is clamped to be moved out of the flexible electrode guide head to be placed in the eyeball.
The surgical instrument assembly for implanting the retina implant according to the embodiment of the invention has a simple structure. Compared with the traditional mode of clamping the flexible electrode by using tweezers, the invention can curl the electrode array of the flexible electrode in the two bending parts, and reduce the whole width of the electrode array, thereby ensuring that the surgical incision on the eyeball is smaller and reducing the surgical risk; in addition, the flexible electrode can be protected from external force when passing through an incision on the eyeball. The invention has convenient operation, reduces the operation difficulty and shortens the operation time.
According to some embodiments of the invention, an end of the flexible electrode guide head distal from the grip portion has a first inclined edge that is inclined upward in a direction toward the grip portion and away from the bottom surface.
According to some embodiments of the invention, the end of the flexible electrode guide head connected to the grip portion has a second inclined edge that is inclined upwardly in a direction away from the grip portion and away from the bottom surface.
According to some embodiments of the invention, an end edge of the bottom portion remote from the grip portion is a forward extending arc-shaped edge.
According to some embodiments of the invention, the top surface has a guide surface at an end of the flexible electrode guide head remote from the grip portion, the guide surface being inclined upwardly in a direction towards the grip portion and away from the bottom surface.
According to some embodiments of the invention, the two bending parts and the bottom part are respectively bent in a J shape.
According to some embodiments of the invention, a width of the flexible electrode lead head is less than a width of the electrode array of the flexible electrode.
According to some embodiments of the invention, a connecting portion is connected between the holding portion and the flexible electrode guide head, and a cross-sectional dimension of the connecting portion is smaller than a cross-sectional dimension of the flexible electrode guide head.
According to some embodiments of the invention, an angle between the flexible electrode guide head and the grip portion is greater than 90 °.
According to some embodiments of the invention, the material of the flexible electrode lead is titanium alloy, pure titanium, platinum iridium alloy, stainless steel, or a noble metal.
Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.
Drawings
The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:
FIG. 1 is a perspective view of a surgical instrument assembly for implanting a retinal implant according to an embodiment of the present invention;
FIG. 2 is a front view of the ophthalmic surgical instrument illustrated in FIG. 1;
FIG. 3 is a perspective view of a flexible electrode lead of the ophthalmic surgical instrument shown in FIG. 1;
FIG. 4 is a front view of the flexible electrode lead shown in FIG. 3;
FIG. 5 is a perspective view of a retinal implant according to an embodiment of the present invention;
fig. 6 is a schematic view of a retinal implant according to an embodiment of the present invention when implanted in an eyeball.
Reference numerals:
100: an ophthalmic surgical instrument;
1: a grip portion; 2: a flexible electrode lead;
21: a bottom; 211: a top surface; 2111: a guide surface; 212: a bottom surface; 213: an arcuate edge;
22: a bending part; 23: a space; 24: a first inclined edge; 25: a second inclined edge;
3: a connecting portion;
200: a retinal implant; 201: an array of electrodes; 202: a suture section;
300: an eyeball; 301: a retina; 302: cutting; 400: and (5) fixing the nail.
Detailed Description
Embodiments of the present invention will be described in detail below, the embodiments described with reference to the drawings being illustrative, and the embodiments of the present invention will be described in detail below.
A surgical instrument assembly 100 for implanting a retinal implant according to an embodiment of the present invention is described below with reference to fig. 1-6.
As shown in fig. 1 to 4, a surgical instrument assembly 100 for implanting a retinal implant according to an embodiment of the present invention includes a grip 1 and a flexible electrode lead 2.
Wherein one end (for example, the back end marked in fig. 1) of the flexible electrode guide head 2 is connected with the holding part 1, the flexible electrode guide head 2 comprises a bottom part 21 and two bending parts 22, and the bottom part 21 has a top surface 211 and a bottom surface 212. Referring to fig. 4, the top surface 211 and the bottom surface 212 are respectively located on both sides in the thickness direction of the bottom portion 21 (e.g., the up-down direction marked in fig. 1 and 3), and the top surface 211 is located above the bottom surface 212.
Two bent portions 22 are connected to both sides (for example, left and right sides marked in fig. 1 and 3) of the bottom portion 21, and the two bent portions 22 are located on the side where the top surface 211 of the bottom portion 21 is located and bent toward directions close to each other. For example, as shown in fig. 2 and 4, the two bent portions 22 may extend from the end connected to the bottom portion 21 to be bent upward and gradually approach each other. A space 23 for accommodating the flexible electrode is formed between the two bent portions 22 and the bottom portion 21.
For example, in the process of implanting the flexible electrode, before the flexible electrode enters the incision 302 on the sclera of the eyeball 300, the electrode array 201 of the flexible electrode can be placed in the above space 23 formed by the two bending parts 22 and the bottom part 21 of the flexible electrode guide head 2, then the holding part 1 is held, the flexible electrode guide head 2 can smoothly pass through the incision 302, another surgical tool can be inserted into another position of the eyeball 300, the electrode array 201 is clamped and removed from the flexible electrode guide head 2, so that the purpose of delivering the electrode array 201 into the interior of the eye is achieved, and then the ophthalmic surgical instrument 100 is removed from the incision 302. The whole operation process is simple, the operation of the doctor is convenient, and the time consumption is short.
The surgical instrument assembly 100 for implanting a retinal implant according to an embodiment of the present invention has a simple structure. Compared with the traditional mode of clamping the flexible electrode by forceps, the embodiment of the invention can enable the electrode array 201 of the flexible electrode to curl in the two bending parts 22, so that the whole width of the electrode array is reduced, the operation incision 302 on the eyeball 300 can be ensured to be smaller, and the operation risk is reduced; furthermore, the flexible electrodes may be protected from external forces while passing through the incision 302 in the eyeball 300. The invention has convenient operation, reduces the operation difficulty and shortens the operation time.
According to some embodiments of the present invention, referring to fig. 1 in combination with fig. 3, an end of the flexible electrode lead 2 distal from the grip 1 (e.g., the front end labeled in fig. 1 and 3) has a first inclined edge 24, the first inclined edge 24 being inclined upward in a direction toward the grip 1 and away from the bottom surface 212. For example, in the example of fig. 1 and 3, the height of the flexible electrode guide head 2 gradually increases in a direction toward the grip portion 1. The first inclined edge 24 is provided to facilitate the flexible electrode guide head 2 to enter the eyeball 300 through the incision 302, so that the eyeball 300 is not easily injured.
Further, as shown in fig. 1 and 3, one end (e.g., the rear end marked in fig. 1 and 3) of the flexible electrode lead 2 connected to the grip 1 has a second inclined edge 25, and the second inclined edge 25 is inclined upward in a direction away from the grip 1 and away from the bottom surface 212. For example, referring to fig. 1 and 3, the height of the flexible electrode lead 2 gradually increases in a direction away from the grip 1. Therefore, by providing the second inclined edge 25, the flexible electrode guide head 2 can be moved out of the eyeball 300 more conveniently, and the trauma to the eyes can be reduced.
For example, in the example of fig. 1 and 3, the front end of the flexible electrode lead 2 has a first inclined edge 24, and the rear end has a second inclined edge 25, and when the length of each bent portion 22 in the front-rear direction is gradually reduced from bottom to top, the first inclined edge 24 and the second inclined edge 25 may be symmetrical front to back, which can further ensure the guiding effect.
Alternatively, referring to fig. 3, an edge of an end (e.g., the front end marked in fig. 1 and 3) of the bottom portion 21 away from the grip portion 1 is an arc-shaped edge 213 extending forward. The whole arc-shaped edge 213 is in smooth transition, the incision 302 can be gradually opened by the flexible electrode guiding head 2 in the left and right directions, and the trauma to the eyes is effectively reduced.
According to a further embodiment of the invention, in connection with fig. 3, the top surface 211 has a guide surface 2111, the guide surface 2111 being located at an end of the flexible electrode guide head 2 remote from the grip 1, the guide surface 2111 being inclined upwards in a direction towards the grip 1 and away from the bottom surface 212. At this time, the thickness of the front end edge of the bottom 21 is thinner, and the flexible electrode lead 2 can gradually open the incision 302 in the up-down direction, so as to reduce the trauma to the eyes. Alternatively, the guide surface 2111 may be formed as an inclined plane extending obliquely in a direction toward the grip portion 1, which is simple to machine and low in cost, but is not limited thereto.
Alternatively, the two bending portions 22 and the bottom portion 21 are respectively bent in a J shape, as shown in fig. 4. Therefore, smooth transition is performed between each bending part 22 and the bottom part 21, so that the flexible electrode is conveniently accommodated, and the flexible electrode is prevented from being damaged.
According to some alternative embodiments of the invention, the width of the flexible electrode lead 2 is smaller than the width of the electrode array 201 of flexible electrodes. Because the electrode array 201 is wound, the width of the flexible electrode guide head 2 can be small, and then the incision 302 can be narrowed to smoothly complete the implantation operation, thereby reducing the eye trauma.
Specifically, for example, the width of the electrode array 201 is generally 4-6mm in the prior art, and the width of the incision 302 is generally 0.5-2mm wider than the electrode array 201, so that it can smoothly extend into the eyeball 300. After the ophthalmologic surgical instrument 100 according to the embodiment of the present invention is used, the width of the flexible electrode guide head 2 can be designed to be smaller than the width of the electrode array 201, so that the width of the incision 302 can be smaller than the conventional incision width, thereby reducing the surgical risk, reducing the eye trauma, and facilitating the postoperative rehabilitation.
According to a further embodiment of the present invention, as shown in fig. 1-4, a connecting portion 3 is connected between the grip portion 1 and the flexible electrode lead 2, and the cross-sectional size of the connecting portion 3 is smaller than that of the flexible electrode lead 2. For example, in the example of fig. 1 to 4, the connection part 3 may be cylindrical, the width of the connection part 3 may be smaller than the width of the flexible electrode lead 2, the height of the connection part 3 may be smaller than the height of the flexible electrode lead 2, and the connection part 3 may be located in the same horizontal plane as the bottom 21 of the flexible electrode lead 2 so as to smoothly feed the flexible electrode lead 2 into the eye. The connecting part 3 can extend the flexible electrode guide head 2 forwards by a proper length, so that the operation is convenient; in addition, the connecting part 3 has a small section, so that the doctor can conveniently observe the flexible electrode guide head 2.
Optionally, referring to fig. 1, an included angle between the flexible electrode guiding head 2 and the holding portion 1 is greater than 90 °, and a doctor can directly observe the state of the flexible electrode guiding head 2 and the flexible electrode thereon, so as to facilitate surgical operation.
Optionally, the material of the flexible electrode lead 2 is titanium alloy, pure titanium, platinum iridium alloy, stainless steel, noble metal, or the like. Therefore, the flexible electrode guide head 2 is made of a harder material and has better biocompatibility, so that the electrode array 201 can be more conveniently guided into the eye.
Referring to fig. 1-4 in conjunction with fig. 5-6, the retinal implant 200 is implanted as follows: the electronic package of the retinal implant 100 is first sutured to the superior temporal quadrant of the sclera and the distance between the suture 202 and the limbus is secured, then a vitrectomy procedure is performed with the sclera incised at the superior temporal quadrant to form an incision 302, the electrode array 201 is introduced into the eyeball 300 from the incision 302, and the electrode array 201 is fixed to the macular area on the surface of the retina 301 by means of the fixation pins 400.
In the present invention, the electrode array 201 is guided by the special ophthalmic surgical instrument 100, and the electrode array 201 can be conveniently transferred to the space 23 inside the eye. Thereafter, another clamping tool can be inserted into another position outside the incision 302 to remove the electrode array 201 from the flexible electrode lead 2 of the present application, and then the flexible electrode lead 2 is removed from the incision 302, and then the surgical steps of implanting the fixing nail 400 and the like are performed. The whole operation process is simple, the operation of the doctor is convenient, and the time consumption is short.
In order to avoid damage to the electrode array 201 by the flexible electrode lead 2, a protective layer (not shown) may be wrapped around the edge of the electrode array 201, and the material of the protective layer is preferably silicone, and may also be Polyimide (Polyimide), Polypropylene (Polypropylene), Polyethylene Terephthalate (PET, PETE, Polyethylene Terephthalate), or parylene, and the like, and is formed on the electrode array 201 by injection molding or spin coating.
While embodiments of the invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims (10)

1. A surgical instrument assembly for implanting a retinal implant, the retinal implant comprising an electronics package and a flexible electrode, the surgical instrument assembly comprising an ophthalmic surgical instrument and a surgical tool, the ophthalmic surgical instrument comprising a grip and a flexible electrode guide head, wherein:
one end of the flexible electrode guide head is connected with the holding part, the flexible electrode guide head comprises a bottom part and two bending parts, and the bottom part is provided with a top surface and a bottom surface;
the two bending parts are connected to two sides of the bottom part, are positioned on one side of the top surface and bend towards directions close to each other;
a space for accommodating the flexible electrode is formed between the two bending parts and the bottom;
when the retina implant is implanted into an eyeball, the electronic packaging body is arranged on the outer surface of the eyeball, the flexible electrode guide head accommodating the electrode array of the flexible electrode is suitable for passing through an incision of the eyeball, the surgical tool is inserted into another position of the eyeball, and the electrode array is clamped to be moved out of the flexible electrode guide head so as to be placed in the eyeball.
2. The surgical instrument assembly for implanting a retinal implant of claim 1, wherein an end of the flexible electrode guide head distal from the grip portion has a first angled edge that is angled upward in a direction toward the grip portion and away from the bottom surface.
3. The surgical instrument assembly for implanting a retinal implant of claim 1, wherein an end of the flexible electrode guide head connected to the grip portion has a second angled edge that is angled upward in a direction away from the grip portion and away from the bottom surface.
4. The surgical instrument assembly for implanting a retinal implant of claim 1, wherein an end edge of the base portion distal from the grip portion is a forward extending arcuate edge.
5. The surgical instrument assembly for implanting a retinal implant of claim 1, wherein the top surface has a guide surface at an end of the flexible electrode guide head distal from the grip portion, the guide surface sloping upward in a direction toward the grip portion and away from the bottom surface.
6. The surgical instrument assembly for implanting a retinal implant of claim 1, wherein each of the two bends is J-shaped with respect to the base.
7. A surgical instrument assembly for implanting a retinal implant according to claim 1, wherein the width of the flexible electrode lead is less than the width of the electrode array of the flexible electrode.
8. The surgical instrument assembly for implanting a retinal implant of any one of claims 1-7, wherein a connecting portion is connected between the gripping portion and the flexible electrode lead, the connecting portion having a cross-sectional dimension that is smaller than a cross-sectional dimension of the flexible electrode lead.
9. The surgical instrument assembly for implanting a retinal implant of any of claims 1-7, wherein an angle between the flexible electrode guide head and the grip portion is greater than 90 °.
10. The surgical instrument assembly for implanting a retinal implant of any of claims 1-7, wherein the material of the flexible electrode lead is a titanium alloy, pure titanium, platinum iridium, stainless steel, or a noble metal.
CN202011439339.3A 2020-12-10 2020-12-10 Surgical instrument assembly for implanting a retinal implant Active CN112451207B (en)

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CN114469509B (en) * 2022-02-24 2023-03-31 微智医疗器械有限公司 Ophthalmologic operation forceps

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CN103124540A (en) * 2010-07-05 2013-05-29 Ucl商业股份有限公司 Device for deploying a flexible implant
CN108983959A (en) * 2018-05-24 2018-12-11 珠海市大悦科技有限公司 A kind of system and method for artificial vision
CN108903916A (en) * 2018-07-31 2018-11-30 浙江大学 The implant needle and method for implantation of flexible implanted biosensor and photoelectric device
CN209500048U (en) * 2019-01-03 2019-10-18 何建中 A kind of artificial retina implantation assistor

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