CN213852762U - Stimulation lead and stimulation system including the same - Google Patents

Stimulation lead and stimulation system including the same Download PDF

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CN213852762U
CN213852762U CN202021532108.2U CN202021532108U CN213852762U CN 213852762 U CN213852762 U CN 213852762U CN 202021532108 U CN202021532108 U CN 202021532108U CN 213852762 U CN213852762 U CN 213852762U
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stimulation
stimulation lead
lead
longitudinal direction
fixing
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王乐今
苗泽群
王天放
王文思
黄旅珍
王登伟
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Chaomu Technology Beijing Co ltd
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Chaomu Technology Beijing Co ltd
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Abstract

A stimulation lead and a stimulation system including the same are provided. The stimulation lead is used to direct electrical stimulation to the site to be stimulated. The stimulation lead includes: an insulative housing extending proximally from the distal end in a longitudinal direction; an electrode contact disposed at a distal end of the insulative housing and at least partially exposed outside of the insulative housing; an inner conductor connecting the electrode contact to the electrical stimulation source and extending at least partially in the longitudinal direction inside the insulating housing. Wherein the inner conductor is configured to be retractable to enable a length of the inner conductor to be varied in the longitudinal direction. The electrode contacts of the stimulation lead can be stably positioned at a specific location.

Description

Stimulation lead and stimulation system including the same
Technical Field
The present invention relates to a stimulation lead and a stimulation system comprising such a stimulation lead, which stimulation lead and stimulation system are particularly suitable for stimulating extraocular muscles.
Background
Nystagmus is an involuntary, rhythmic and reciprocating eye swing or bounce with complex clinical manifestations often accompanied by binocular visual impairment. Nystagmus is classified into types of nystagmus, vestibular nystagmus, central nystagmus, and nystagmus of unknown origin according to its primary disease.
Among them, Nystagmus is closely related to ophthalmology clinic and is mainly Congenital Nystagmus (CN), which often occurs within 4 months after birth or birth, and according to statistics, the prevalence rate in children is 1/1000-1/1500, and there are about millions of patients all over the world. Congenital nystagmus is classified according to etiology: perception-deficient Nystagmus (SDN) and motor-deficient Nystagmus (CIN).
Motion-deficient nystagmus belongs to the defect of a congenital efferent mechanism, has a normal afferent mechanism and is not combined with the abnormality of eyes, and is often expressed as impulsive nystagmus. The major harm of movement-deficient nystagmus is to cause amblyopia, and according to data statistics, the amblyopia cases account for 86.7 percent and the moderate and severe amblyopia accounts for 20.2 percent of the patients; moderate amblyopia accounted for 52.3%. It follows that the effect of movement-deficient nystagmus on vision is widespread.
The specific pathogenesis of the movement-deficient nystagmus is unclear, and an effective means is clinically lacked, so that the movement-deficient nystagmus is always a difficult point and an important disease faced by ophthalmology.
Chinese patent publication CN106861041A describes an implantable extraocular neuromuscular stimulator for treating nystagmus and a parameter setting method thereof, which provides corresponding stimulation to extraocular muscles, balances nerve stimulation, and counteracts contraction by detecting the contraction condition and stimulation signal of the extraocular muscles so as to keep the eyeball in fixation without nystagmus.
The muscle or nerve stimulator includes an electrical stimulation source for generating a stimulation signal and a stimulation lead provided with an electrode contact thereon for delivering the stimulation signal generated from the electrical stimulation source to a specific site to be stimulated. There is a need for a stimulation lead that stably and accurately delivers stimulation signals from an electrical stimulation source to a site to be stimulated, such as the extraocular muscles.
SUMMERY OF THE UTILITY MODEL
At least one embodiment of the present disclosure provides a stimulation lead for directing electrical stimulation to a site to be stimulated. The stimulation lead includes: an insulative housing extending proximally from the distal end in a longitudinal direction; an electrode contact disposed at a distal end of the insulative housing and at least partially exposed outside of the insulative housing; an inner conductor connecting the electrode contact to an electrical stimulation source and extending at least partially within the insulative housing along the longitudinal direction. The inner conductor is configured to be retractable to enable a length of the inner conductor to be changed in the longitudinal direction.
Since the inner conductor is configured to be stretchable and contractible so as to be able to change the length of the inner conductor in the longitudinal direction, the inner conductor can change its length with the movement of the eyeball, thereby resulting in that the electrode contact connected to the inner conductor thereof can be more stably positioned at a specific position.
For example, in some embodiments, the inner conductor comprises a helical section that extends in a spiral or zigzag manner along the longitudinal direction of the stimulation lead.
For example, in some embodiments, the helical section is located inside the insulating housing.
For example, in some embodiments, the insulating housing has elasticity to enable a change in length of the insulating housing in the longitudinal direction.
Accordingly, the insulating housings may change their respective lengths along with the inner conductors, so that the electrode contacts can be more stably positioned at specific positions.
For example, in some embodiments, the insulating housing is made of silicone.
For example, in some embodiments, the insulative housing includes a stimulation segment at a distal end and a connection segment extending proximally from the stimulation segment in the longitudinal direction, the electrode contacts being secured to the stimulation segment, the stimulation segment being flat in shape.
The flat shaped stimulation segment can be more stably conformed and placed at the site to be stimulated.
For example, in some embodiments, the stimulation segment includes a thickness and a width, a ratio of the thickness and the width being in a range of 1/4 to 1/2.
For example, in some embodiments, the connecting section is cylindrical in shape, and the insulating housing further comprises a transition section disposed between the connecting section and the stimulation section.
For example, in some embodiments, the stimulation lead further comprises at least one fixation portion disposed on the insulative housing for securing the stimulation lead.
The fixation portion is advantageous to ensure that the position of the stimulation lead, in particular the distal part of the stimulation lead, with respect to the site to be stimulated remains unchanged.
For example, in some embodiments, the at least one securing portion is provided with a securing aperture for passing a securing cable therethrough.
For example, in some embodiments, the fixation holes have a diameter in the range of 0.1-0.2 mm.
For example, in some embodiments, the stimulation lead further comprises at least one fixation portion disposed on the insulative housing for securing the stimulation lead. The at least one fixing portion includes a plurality of first fixing portions disposed at the stimulation section of the insulating housing, which are respectively disposed at both sides of the electrode contact along the longitudinal direction.
For example, in some embodiments, the at least one fixation portion further comprises a second fixation portion near a proximal end of the stimulation lead relative to the first fixation portion, a distance in the longitudinal direction between the second fixation portion and the first fixation portion being greater than a distance in the longitudinal direction between the plurality of first fixation sections.
The second fixation section helps isolate the influence of proximal forces on the electrode contacts at the distal end of the stimulation lead.
For example, in some embodiments, the distance between the plurality of first fixation portions is in the range of 1-5mm, and the distance between the second fixation portion and the first fixation portion is in the range of 1-30 mm.
For example, in some embodiments, the stimulation lead further comprises at least one fixation portion disposed on the insulative housing for securing the stimulation lead. The at least one fixation portion includes a plurality of first fixation portions disposed at the stimulation section of the insulative housing and a second fixation portion disposed at the transition section of the insulative housing.
For example, in some embodiments, the inner conductor is soldered to the electrode contact.
For example, in some embodiments, the distal end of the stimulation lead is configured to be placed at an extraocular muscle, and the length of the stimulation lead is in the range of 15-21 cm.
This length is particularly suitable for a stimulation lead used to stimulate the extraocular muscles.
At least one embodiment of the present disclosure provides a stimulation system including an electrical stimulation source and a stimulation lead as described above, a proximal end of the stimulation lead being connected to the electrical stimulation source.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present disclosure, and therefore should not be considered as limiting the scope of protection, and for those skilled in the art, other related drawings may be obtained from the drawings without inventive effort.
Fig. 1 shows a schematic top view of a stimulation lead according to an embodiment of the present disclosure;
FIG. 2 shows an enlarged view of the portion of FIG. 1 where the electrode contacts are located;
fig. 3 is a schematic side view of the stimulation lead of fig. 1;
fig. 4 shows a schematic top view of a stimulation lead and an electrical stimulation source according to another embodiment of the present disclosure;
FIG. 5 shows an enlarged view of the circled portion in FIG. 4;
fig. 6 shows a schematic diagram of a stimulation system including a stimulation lead according to another embodiment of the present disclosure.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.
Unless otherwise defined, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The use of "first," "second," and similar terms in this disclosure is not intended to indicate any order, quantity, or importance, but rather is used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. "upper", "lower", "left", "right", etc. are used merely to indicate relative positioning, and when the absolute positioning of the object being described is changed, the relative positioning may also be changed accordingly.
Fig. 1 shows a schematic top view of a stimulation lead according to an embodiment of the present disclosure, fig. 2 shows an enlarged view of the portion of fig. 1 where the electrode contacts are located, and fig. 3 shows a schematic side view of the stimulation lead of fig. 1. The stimulation lead is included in a stimulation system, and the stimulation system also includes an electrical stimulation source 150, such as a pulse generator. The stimulation lead may be used to direct the stimulation signal generated by electrical stimulation source 150 to a stimulation site, such as an extraocular muscle. However, stimulation leads according to the present disclosure are not limited to such ophthalmic applications. Stimulation leads according to the present disclosure may also be applied to other stimulation systems, such as stimulation leads included in spinal cord stimulation systems and having distal ends configured for placement near the spinal cord, stimulation leads included in cochlear implants and having distal ends configured for placement in the ear, and the like.
As shown in fig. 1-3, the stimulation lead is in the form of a strip that extends in a longitudinal direction and has a proximal end for connection to an electrical stimulation source 150 and a distal end for placement at a site to be stimulated, such as the extraocular muscle. The stimulation lead includes an electrode contact 110, an inner conductor 120, and an insulating housing 130.
The electrode contacts 110 are one or more, which are positioned at the distal end of the stimulation lead. Preferably, the electrode contact 110 is plural. Thus, in the event that one or some of the electrode contacts 110 fails, the other electrode contacts 110 may be used for stimulation operations. In addition, since each specific portion of the extraocular muscle has different impedance and different nerve distribution, each electrode contact 110 has different effects of applying electrical stimulation at its location, and the plurality of electrode contacts 110 allows more suitable electrode contacts 110 to be selected according to the stimulation effects to achieve better treatment effects.
In the present example, the number of the electrode contacts 110 is 4, which are arranged in pairs in series in the longitudinal direction in a 2 × 2 array. The four electrode contacts 110 are stimulation electrodes. Further, a feedback electrode may also be provided at the electrical stimulation source 150 or near the proximal end of the stimulation lead, but the position of the feedback electrode is not limited thereto. The feedback electrode is mainly used for feeding back the electrical stimulation signal, if the stimulation signal is sent by the front-end stimulation electrode, the feedback electrode receives the electrical signal sent by the front-end stimulation electrode to form a loop, and whether the sent electrical stimulation signal is the electrical stimulation signal sent by the stimulator is determined.
The electrode contacts 110 may comprise, for example, a metal such as platinum, iridium, gold, and preferably made of a platinum-iridium alloy.
The inner conductor 120 extends in the longitudinal direction of the stimulation lead, is electrically connected at a proximal end to an electrical stimulation source 150 to receive the stimulation signal, and is electrically connected at a distal end to the electrode contact 110 to deliver the received stimulation signal to the electrode contact 110. The inner conductor 120 may be electrically connected to the electrode contact 110 by soldering. Fig. 2 shows a solder joint 121 branching off of the inner conductor 120 to one of the electrode contacts 110.
Only one inner conductor 120 is shown in fig. 1, which is simultaneously connected to multiple electrode contacts 110 at the distal end of the stimulation lead. But the present disclosure is not limited thereto. The stimulation lead may also include a plurality of inner conductors 120 that are each connected to a different electrode contact 110 to independently deliver stimulation signals to the different electrode contacts 110.
For example, fig. 4 shows a schematic top view of a stimulation lead and electrical stimulation source 150 according to another embodiment of the present disclosure, and fig. 5 shows an enlarged view of the circled portion in fig. 4. As shown in fig. 4 and 5, the stimulation lead includes four inner conductors 120 connected to four different electrode contacts 110 by respective solder joints 121.
The inner conductor 120 may comprise, for example, a metal such as platinum, iridium, gold, and preferably made of a platinum-iridium alloy.
Referring back to fig. 1-3, the insulative housing 130 extends in the longitudinal direction of the stimulation lead, which encases at least a portion of the length of the inner conductor 120 and secures the electrode contact 110. The insulating housing 130 at least partially exposes the electrode contact 110 to allow the electrode contact 110 to contact a site to be stimulated to apply a stimulation signal. Preferably, the electrode contacts 110 are all exposed to one side of the insulating housing 130 to ensure that the stimulation signal is applied to the extraocular muscles, but not to other nerve or muscle sites.
When a stimulation lead is placed over a site to be stimulated, such as the extraocular muscles, it tends to shift (e.g., when the eye rotates), which can result in the failure to apply the appropriate stimulation signal at the appropriate site. Stimulation leads according to embodiments of the present disclosure more readily stably maintain their position for application of a stable stimulation signal.
In some embodiments, the insulated housing 130 of the stimulation lead can include a stimulation segment 132 at the distal end, a connecting segment 131 extending proximally from the stimulation segment 132, and a transition segment 133 between the connecting segment 131 and the stimulation segment 132, the electrode contact 110 being secured to the stimulation segment 132. The stimulation section 132 may be designed in a flat shape, rather than a cylindrical shape, so that the stimulation section 132 may be more stably fitted and placed at a site to be stimulated, such as the extraocular muscle. The stimulation segment 132 may include a height and a width. For example, the ratio of the thickness to the width is in the range of 1/4 to 1/2. For example, in the case of a flat shape for the retention stimulation segment 132, the thickness may be in the range of 0.1-2mm, while the width may be in the range of 1-12 mm. In addition, the connection segment 131 may be designed in a cylindrical shape to facilitate processing and placement of the inner conductor 120.
For example, when the eyeball rotates, the electrode contact 110 on the stimulation section 132 may not follow the movement of the extraocular muscle due to the pulling or pushing force of the connection section 131, so as not to maintain its specific position relative to the extraocular muscle. In some embodiments, the inner conductor 120 of the stimulation lead comprises a helical section extending in a helical or zigzag manner along the longitudinal direction of the stimulation lead to enable the length of the inner conductor 120 to be varied in the longitudinal direction. Changing the length of the inner conductor 120 in the longitudinal direction as a function of pulling or pushing forces may prevent eyeball rotation from causing the position of the distal portion of the stimulation lead (and particularly the electrode contact 110) to be changed relative to the extraocular muscles and, for example, the proximal portion of the stimulation lead and the electrical stimulation source 150 connected to the proximal portion to be changed relative to the implanted site. Therefore, the stimulation lead has good tensile resistance and compression resistance. In some examples, the inner conductor 120 may extend in a spiral or zigzag manner substantially over its entire length.
In the present embodiment, the spiral section is located inside the insulating housing 130. The insulating housing 130 of the stimulation lead is designed to be flexible and also resilient. Since the insulating housing 130 has elasticity, it can change its length in the longitudinal direction together with the inner conductor 120, thereby ensuring stable positions of the distal and proximal portions of the stimulation lead. For example, the insulating housing 130 may be made of silicone rubber, and the silicone rubber is implant-grade silicone rubber, which has long-term biosafety. For example, the insulating housing 130 is formed around the inner conductor 120 by overmolding.
In some embodiments, the stimulation lead may further comprise at least one fixation portion provided with a fixation hole for passing a fixation cable for fixing the stimulation lead to the site to be stimulated. The size of the fixation hole may be determined according to the size of the surgical suture. In some examples, the fixation holes have a diameter in the range of 0.1-0.2 mm. The fixation portion is advantageous to ensure that the position of the stimulation lead, in particular the distal part of the stimulation lead, remains unchanged.
The at least one fixing portion may include a first fixing portion 141 and a second fixing portion 142. The first fixing portion 141 is disposed at the stimulating section 132. Also, the first fixing portion 141 may be plural and disposed at both sides of the electrode contact 110 and at the edge of the stimulation section 132, respectively, in the longitudinal direction. The second fixing portion 142 may be disposed such that its distance from the first fixing portion 141 is greater than the distance between the plurality of first fixing portions 141 to further stabilize the position of the stimulating section 132 and isolate the influence of force at the connecting section 131, such as due to eyeball rotation, on the stimulating section 132. For example, the second fixing portion 142 may be provided in the transition section 133. For example, the second fixing portions 142 may be two, which are tabs respectively protruding from both sides of the insulating housing 130. The second fixing portion 142 is designed as a tab protruding from both sides of the insulation case 130 to facilitate the surgeon's manipulation. Due to the arrangement of the first and second fixing portions 141 and 142, the stimulation lead is more stably placed.
For example, the first fixing portions 141 may be spaced apart from each other by a distance in the range of 1-5mm, and the distance between the first and second fixing portions 141 and 142 may be in the range of 1-30 mm.
In this embodiment, the stimulation lead is applied to an extraocular neuromuscular stimulator. The extraocular neuromuscular stimulator includes, in addition to stimulation leads, an electrical stimulation source 150, e.g., a pulse generator, for generating extraocular stimulation signals. The proximal end of the stimulation lead is connected directly to the electrical stimulation source 150, while the distal end is placed over the extraocular muscle. The electrical stimulus 150 may be placed in a bony groove located in the mastoid region behind the ear. To suit such applications, the total length of the stimulation lead is designed to be in the range of 15-21cm, reserving a redundant length of about 5cm from the site where the electrical stimulation source 150 is implanted to the site to be stimulated. When the electrical stimulation source 150 is placed in the bone groove, the feedback electrode can be placed in the bone groove at the same time to protect the feedback electrode and ensure the reliability of the feedback electrode.
The surgical procedure for implanting electrical stimulation source 150 and stimulation leads into the body is described in detail below.
The surgical procedure comprises:
s1, general anesthesia of the patient, sterilization and drape of the operation area and eyelid opening;
s2, making subtopic Parks conjunctiva incision;
s3, hooking the external rectus muscle by the strabismus hook, separating fascia and ligament control, and fully exposing the external rectus muscle;
s4, making a 1cm long outer canthus incision, exposing the orbit at the outer canthus, grinding a 0.5 x 0.5cm notch by using a bone drill, and making a puncture from the outer canthus to the parss incision at the fornix part;
s5, making a posterior auricular incision to expose cortex lycii radicis of a mastoid region, and making a bone bed for placing an electric stimulation source on the surface of a skull above the back of the mastoid by using an electric drill;
s6, making a subcutaneous tunnel from the bone bed to the outer canthus by using the poker, and passing out from the outer canthus incision;
s3, placing the electrical stimulation source in a bone bed for fixation, sending the far end of the stimulation lead to the outer canthus incision along the poker, and withdrawing the poker;
s7, the distal end of the stimulation lead is sent to subconjunctival space at the Parks incision through an outer canthus notch and a puncture;
s8, hooking the external rectus muscle by an oblique hook, and fixing the fixed part of the stimulation lead to the two sides of the muscle abdomen by using a suture;
s9, after disinfection, suturing the operation incision; and (6) resetting the conjunctival flap.
The distal end of the stimulation lead is implanted inside the extraocular muscle, passes through the conjunctival incision and the outer canthal breach and is guided to the subcutaneous tunnel so that the proximal end of the stimulation lead is guided through the subcutaneous tunnel to and connected to an electrical stimulus source 150 placed at the bony bed of the retroauricular mastoid region.
Those skilled in the art will appreciate that the stimulation leads may also be placed in other ways. For example, the stimulation leads are directed directly outside the human body and connected to an electrical stimulation source 150 disposed outside the human body. For example, electrical stimulation source 150 may be placed within the body, such as at the bone bed of the mastoid region behind the ear. For example, fig. 6 shows a schematic diagram of a stimulation system including a stimulation lead according to another embodiment of the present disclosure. As shown in fig. 6, an electrical stimulation source 150 is placed outside the human body and is connected to at least a portion of a stimulation lead placed inside the human body.
The scope of the present disclosure is not defined by the above-described embodiments but is defined by the appended claims and equivalents thereof.

Claims (18)

1. A stimulation lead for directing electrical stimulation to a site to be stimulated, the stimulation lead comprising:
an insulative housing extending proximally from the distal end in a longitudinal direction;
an electrode contact disposed at a distal end of the insulative housing and at least partially exposed outside of the insulative housing;
an inner conductor connecting the electrode contact to an electrical stimulation source and extending at least partially inside the insulating housing along the longitudinal direction,
wherein the inner conductor is configured to be retractable to enable a length of the inner conductor to be varied in the longitudinal direction.
2. The stimulation lead of claim 1,
the inner conductor includes a helical section that extends in a spiral or zigzag manner along the longitudinal direction of the stimulation lead.
3. The stimulation lead of claim 2,
the helical section is located inside the insulating housing.
4. The stimulation lead of claim 2,
the insulating housing has elasticity to enable a length of the insulating housing to be changed in the longitudinal direction.
5. The stimulation lead of claim 4,
the insulating shell is made of silica gel.
6. The stimulation lead of claim 1,
the insulative housing includes a stimulation segment at a distal end and a connection segment extending proximally from the stimulation segment in the longitudinal direction, the electrode contact being secured to the stimulation segment, the stimulation segment being flat in shape.
7. The stimulation lead of claim 6,
the stimulation segment includes a thickness and a width, a ratio of the thickness and the width being in a range of 1/4 to 1/2.
8. The stimulation lead of claim 6,
the connecting section is cylindrical, and the insulating shell further comprises a transition section arranged between the connecting section and the stimulation section.
9. The stimulation lead of claim 1, further comprising:
at least one fixing portion disposed on the insulating housing for fixing the stimulation lead.
10. The stimulation lead of claim 9,
the at least one fixing portion is provided with a fixing hole for passing a fixing cable.
11. The stimulation lead of claim 10,
the diameter of the fixing hole is in the range of 0.1-0.2 mm.
12. The stimulation lead of claim 6, further comprising:
at least one fixing portion provided on the insulating housing for fixing the stimulation lead,
the at least one fixing portion includes a plurality of first fixing portions disposed at the stimulation section of the insulating housing, which are respectively disposed at both sides of the electrode contact along the longitudinal direction.
13. The stimulation lead of claim 12,
the at least one fixation portion further includes a second fixation portion proximate a proximal end of the stimulation lead relative to the first fixation portion, a distance between the second fixation portion and the first fixation portion along the longitudinal direction being greater than a distance between the plurality of first fixation segments along the longitudinal direction.
14. The stimulation lead of claim 13,
the distance between the plurality of first fixing portions is in the range of 1-5mm, and the distance between the second fixing portion and the first fixing portion is in the range of 1-30 mm.
15. The stimulation lead of claim 8, further comprising:
at least one fixing portion provided on the insulating housing for fixing the stimulation lead,
the at least one fixation portion includes a plurality of first fixation portions disposed at the stimulation section of the insulative housing and a second fixation portion disposed at the transition section of the insulative housing.
16. The stimulation lead of claim 1,
the inner conductor is soldered to the electrode contact.
17. The stimulation lead of claim 1,
the distal end of the stimulation lead is configured to be placed at an extraocular muscle, the length of the stimulation lead being in the range of 15-21 cm.
18. A stimulation system, comprising:
an electrical stimulation source; and
the stimulation lead of any of claims 1-17, the proximal end of the stimulation lead being connected to the electrical stimulation source.
CN202021532108.2U 2020-07-29 2020-07-29 Stimulation lead and stimulation system including the same Active CN213852762U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117839077A (en) * 2024-03-07 2024-04-09 超目科技(北京)有限公司 Nystagmus electrical stimulation device and method of operation thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117839077A (en) * 2024-03-07 2024-04-09 超目科技(北京)有限公司 Nystagmus electrical stimulation device and method of operation thereof

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