CN111744109A - Pulse generator with wiring grooves arranged on two sides and implantable nerve stimulation system - Google Patents
Pulse generator with wiring grooves arranged on two sides and implantable nerve stimulation system Download PDFInfo
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- CN111744109A CN111744109A CN202010504854.9A CN202010504854A CN111744109A CN 111744109 A CN111744109 A CN 111744109A CN 202010504854 A CN202010504854 A CN 202010504854A CN 111744109 A CN111744109 A CN 111744109A
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- 230000007383 nerve stimulation Effects 0.000 title abstract description 7
- 210000003625 skull Anatomy 0.000 claims abstract description 23
- 238000009434 installation Methods 0.000 claims description 44
- 230000000638 stimulation Effects 0.000 claims description 11
- 238000003780 insertion Methods 0.000 claims description 8
- 230000037431 insertion Effects 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 6
- 229920002379 silicone rubber Polymers 0.000 claims description 5
- 238000004891 communication Methods 0.000 claims description 4
- 210000005036 nerve Anatomy 0.000 claims description 4
- 239000004020 conductor Substances 0.000 claims description 3
- 210000000988 bone and bone Anatomy 0.000 abstract description 11
- 238000003825 pressing Methods 0.000 description 16
- 238000002513 implantation Methods 0.000 description 7
- 210000004556 brain Anatomy 0.000 description 5
- WABPQHHGFIMREM-UHFFFAOYSA-N lead(0) Chemical compound [Pb] WABPQHHGFIMREM-UHFFFAOYSA-N 0.000 description 5
- 238000005452 bending Methods 0.000 description 4
- 210000003128 head Anatomy 0.000 description 3
- 238000013461 design Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000000149 penetrating effect Effects 0.000 description 2
- 210000004761 scalp Anatomy 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 238000004804 winding Methods 0.000 description 2
- 208000024827 Alzheimer disease Diseases 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 208000028552 Treatment-Resistant Depressive disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000002639 bone cement Substances 0.000 description 1
- 238000005253 cladding Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 206010015037 epilepsy Diseases 0.000 description 1
- 201000006517 essential tremor Diseases 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
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- 230000002441 reversible effect Effects 0.000 description 1
- 239000000565 sealant Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37514—Brain implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36064—Epilepsy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36067—Movement disorders, e.g. tremor or Parkinson disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36082—Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
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- Health & Medical Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Hospice & Palliative Care (AREA)
- Child & Adolescent Psychology (AREA)
- Developmental Disabilities (AREA)
- Psychiatry (AREA)
- Psychology (AREA)
- Electrotherapy Devices (AREA)
Abstract
The invention provides a pulse generator with wiring grooves arranged on both sides and an implanted nerve stimulation system, wherein the pulse generator comprises: the top cover component comprises a top cover body and an electrode connecting device arranged in the top cover body; a body part including a case, a circuit board mounted inside the case, and a feed-through lead electrically connected to the circuit board; the feed-through lead is inserted into the top cover part and electrically connected with the electrode connecting device; at least two electrode connecting devices are arranged in the top cover body and are arranged in parallel towards the direction far away from the main body component; the electrode connecting device comprises a plurality of connectors, and wiring grooves are formed in the connectors; a wiring groove of an electrode connecting device is provided toward one side of the top cover member; the terminal groove of the other electrode connecting means is disposed toward the other side of the top cover member. The pulse generator is lighter and thinner, the depth of the bone groove formed on the skull is shallower, the pain of a patient is less, and the operation safety is higher.
Description
Technical Field
The invention relates to the technical field of implantable medical instruments, in particular to a pulse generator with wiring grooves arranged on both sides and used for head implantation and an implantable nerve stimulation system.
Background
The deep brain electrical stimulation therapy has the function of effectively treating related diseases by performing electric pulse stimulation on different functional nuclei in the deep brain, and is a reversible nerve regulation treatment method. At present, deep brain electrical stimulation therapy can be applied to treatment of diseases such as Parkinson, epilepsy, spasm, essential tremor and the like, and extensive application research is also being developed in the aspects of treatment of Alzheimer syndrome, refractory depression, post-stroke rehabilitation, pain and the like.
The implanted part in the body of the traditional deep brain electrical stimulation system generally comprises a pulse generator, an extension lead, an electrode fixing device and the like. The pulse generator is implanted under the chest skin and connected with the extension lead, the extension lead is connected with the electrode through the neck skin tunnel, and the electrode penetrates through the skull to be in contact with a target point and is fixed on the skull through a fixing device. However, in the process of implantation and use, the neck movement easily causes connection failure, the skin at the connection site is easy to be broken and the like, which brings great trouble to patients.
Chinese patent document CN109364372A discloses a top cover component, a pulse generator and an implanted electrical stimulation system, wherein two electrode connecting devices for inserting and connecting electrode wires are disposed in the top cover component, and the two electrode connecting devices are disposed in the top cover component in a stacked manner. If the pulse generator is implanted into the head, the human body, the electrode connecting device and the scalp are respectively arranged at the same position along the direction from inside to outside, and because the two electrode connecting devices are arranged in a superposition mode and the thickness of the equipment is large, a deeper bone groove needs to be formed in the skull, and the operation risk is high. Therefore, in order to make the pulse generator meet the new requirements of the current deep brain stimulation operation, the miniaturization design and the reasonable layout of internal devices of the pulse generator are urgently needed.
Disclosure of Invention
Therefore, the technical problem to be solved by the present invention is to overcome the technical defects that the pulse generator of the implantable electrical stimulation system in the prior art has a large size, needs to be provided with a deep bone groove when being implanted into the head, and further causes high risk of the operation, so as to provide a pulse generator with a thinner thickness and a shallow bone groove, thereby providing higher operation safety.
The invention also provides a nerve stimulation system with the pulse generator.
To this end, the present invention provides a pulse generator with a wiring slot arranged on both sides, comprising:
the top cover component comprises a top cover body and an electrode connecting device arranged in the top cover body;
a body member including a housing, a circuit board mounted inside the housing, and a feed-through lead electrically connected to the circuit board; the feed-through lead is inserted into the top cover part and electrically connected with the electrode connecting device;
two electrode connecting devices are arranged in the top cover body and are arranged in parallel towards the direction far away from the main body component;
the electrode connecting device comprises a plurality of connectors, an insulating ring is arranged between every two adjacent connectors, and wiring grooves are formed in the connectors;
a wiring groove of one of the electrode connecting means is provided toward one side of the top cover member;
the terminal groove of the other of the electrode connecting means is disposed toward the other side of the top cover member.
Preferably, the feed-through conductors extend from a side of the housing facing the cover part and are inserted into the cover part and are electrically connected to the corresponding terminal grooves.
As a preferable scheme, one side of the top cover part is provided with a plurality of first limiting grooves, the first limiting grooves are opposite to the wiring grooves of one electrode connecting device, and a part of the feed-through lead directly extends into the wiring grooves of one electrode connecting device after passing through the first limiting grooves to be connected with the connector.
As a preferable scheme, a plurality of second limiting grooves are formed in the other side of the top cover part, the second limiting grooves are opposite to the connector of the other electrode connecting device, and the other part of the feed-through lead passes through the second limiting grooves and then enters the wiring groove of the other electrode connecting device to be connected with the connector.
As a preferred scheme, the electrode connecting device is provided with a first positioning installation part and a second positioning installation part, and an installation position for positioning and installing the first positioning installation part and the second positioning installation part is arranged in the top cover body; the connector with the insulating ring sets up first location installation department with between the second location installation department.
As a preferable scheme, the second positioning installation part is provided with a first fixing hole communicated with an insertion hole of the electrode connecting device for inserting and installing an electrode lead;
a second fixing hole is formed in the top cover body opposite to the first fixing hole;
an elastic cap is arranged at the position of the second fixing hole, and a normally closed opening is formed in the elastic cap;
and the fixing bolt penetrates through the second fixing hole and then is in threaded connection with the first fixing hole, and is used for tightly extruding the electrode lead inserted into the jack.
As a preferable scheme, a containing groove for containing and installing a charging coil is arranged on one side surface of the top cover body, which is far away from the electrode connecting device.
Preferably, the charging coil position is coated by silicon rubber.
Preferably, the electrode connecting device further comprises an antenna, which is arranged at one end of the top cover body far away from the main body component and inside a mounting gap formed between the electrode connecting device and the top cover body.
The present invention also provides an implantable neurostimulation system, comprising:
a pulse generator;
an electrode lead having a connection contact at one end for connection with the pulse generator and a stimulation contact at the other end adapted for connection with a nerve;
a fixation means for fixing the electrode lead to the skull;
an extracorporeal control device capable of wireless communication with the pulse generator;
the pulse generator is any one of the pulse generators described above.
The technical scheme provided by the invention has the following advantages:
1. the pulse generator comprises a top cover part and a main body part, wherein the top cover part comprises a top cover body and an electrode connecting device arranged in the top cover body; the main body part comprises a shell, a circuit board arranged in the shell and a feed-through lead electrically connected with the circuit board; the feed-through lead is inserted into the top cover part and electrically connected with the electrode connecting device; two electrode connecting devices are arranged in the top cover body and are arranged in parallel towards the direction far away from the main body part; according to the pulse generator, the arrangement mode of the electrode connecting device in the top cover part is adjusted, the thickness of the top cover part is reduced, and the thickness of the whole pulse generator is further reduced.
The wiring groove of one electrode connecting device is arranged towards one side of the top cover component, and the wiring groove of the other electrode connecting device is arranged towards the other side of the top cover component, so that a feed-through lead is conveniently extended out of one side of the main body component to the inside of the top cover component, and then directly enters the inside of the wiring groove to be electrically connected with the connector, and the thickness of the top cover component can be reduced. Compared with the prior art, the pulse generator is lighter and thinner, the depth of the bone groove formed on the skull is shallower, the pain of a patient is less, and the operation safety is higher.
2. The feed-through lead of the pulse generator extends out of one side of the shell facing to the top cover part, is inserted into the top cover part and is respectively and electrically connected with the corresponding wiring grooves; the feed-through leads are led out from one side in a concentrated manner and then extend to the top cover part from different positions, so that the main body part can be manufactured in a light and thin manner.
3. The pulse generator is characterized in that the electrode connecting device is arranged closest to the main body part, and the mounting position of the connector enables the wiring groove to be opposite to the first limiting groove arranged on the top cover part, so that the feed-through lead directly enters the wiring groove through the first limiting groove to realize electric connection after extending out of the main body part, and the circuit is short and hardly occupies the internal space of the top cover part.
4. The pulse generator is not connected with the other electrode connecting device closest to the main body part, the other side of the top cover part is also provided with a second limiting groove (namely the first limiting groove and the second limiting groove are respectively positioned at two sides of the top cover part), and the other part of feed-through lead passes through the second limiting groove and then enters the wiring groove of the other electrode connecting device not closest to the main body part.
5. According to the pulse generator, the electrode connecting device is provided with the first positioning installation part and the second positioning installation part, and the top cover body is provided with the installation positions for positioning and installing the first positioning installation part and the second positioning installation part, so that the whole electrode connecting device can be positioned and installed by positioning and installing the first positioning installation part and the second positioning installation part in the top cover body, and the rest space can provide a wiring passage for a feed-through lead.
6. According to the pulse generator, the second positioning installation part is provided with the first fixing hole communicated with the jack, used for inserting the electrode lead, of the electrode connection device, the top cover body opposite to the first fixing hole is provided with the second fixing hole, the second fixing hole is provided with the elastic cap, and the elastic cap is provided with the normally closed opening; the fixing bolt penetrates through the second fixing hole and then is in threaded connection with the first fixing hole. During specific use, a tool penetrates through the normally closed opening of the elastic cap and is matched with the fixing bolt, the fixing bolt is screwed to rotate, and the fixing bolt stretches and retracts relative to the first fixing hole, so that the electrode lead stretching into the jack is fastened or released.
7. According to the pulse generator, the side face, far away from the electrode connecting device, of the top cover body is provided with the accommodating groove for accommodating the charging coil, the charging coil is arranged at the position, and after the pulse generator is implanted into a human body, the position faces outwards, so that the pulse generator is convenient to charge in a manner of being matched with an external charger.
8. According to the pulse generator, the position of the charging coil is coated by the silicon rubber, so that the charging coil can be fixed, and the interference of eddy current and the like can not be generated during charging, thereby being beneficial to improving the charging efficiency.
9. According to the pulse generator, the mounting gap is formed between the end, far away from the main body component, of the top cover body and the electrode connecting device, and the antenna is mounted in the mounting gap.
10. The invention provides an implanted nerve stimulation system, which comprises a pulse generator, an electrode lead, a fixing device and an in-vitro control device, wherein the pulse generator is of the structure.
Drawings
To more clearly illustrate the technical solutions in the prior art or the embodiments of the present invention, the drawings used in the description of the prior art or the embodiments are briefly introduced below.
Fig. 1 is a schematic view of the overall structure of a pulse generator in embodiment 1 of the present invention.
Fig. 2 is a schematic view of the structure of fig. 1 after the top cover member and the body member are separated up and down.
Figure 3 is a rear view of the body member of figure 2.
Fig. 4 is an exploded view of the top cover member of fig. 2.
Fig. 5 is a schematic structural view of the electrode connecting device and the antenna mounted inside the top cover body.
Fig. 6 is a schematic view of the structure of fig. 5 with the electrode connecting means and the antenna removed.
Fig. 7 is a rear view of fig. 6.
Fig. 8 is a perspective view of the elastic cap.
Fig. 9 is a cross-sectional view of fig. 8.
Fig. 10 is a schematic view of the structure of the pulse generator of the present invention fixed to the skull.
Fig. 11 is a cross-sectional view of fig. 10.
Fig. 12 is a schematic view of the overall configuration of the pulse generator in embodiment 2 of the present invention.
Fig. 13 is an exploded view of the structure of fig. 12.
Fig. 14 is an exploded view of the top cover member of fig. 13.
Fig. 15 is a schematic structural view of the electrode connecting device and the antenna mounted inside the top cover body.
Fig. 16 is a rear view of fig. 15.
Fig. 17 is a schematic structural view of the nerve stimulation system fixedly mounted on the skull of a human body.
Fig. 18 is a schematic illustration of an implantation flow for an implantable neurostimulation system.
Reference numerals: 1. a top cover member; 11. a top cover body; 12. a mounting position 13 and a second fixing hole; 14. an elastic cap; 15. a normally closed opening; 16. a containing groove; 17. a mounting gap; 18. recessing; 101. a first limit groove; 102. a second limit groove; 103. a groove; 104. fixing the pressing plate; 105. a pin shaft hole; 2. a main body member; 21. a housing; 22. a feedthrough lead; 3. an electrode connecting means; 31. a first electrode connecting means; 32. a second electrode connecting means; 301. a connector; 302. an insulating ring; 303. a wiring slot; 304. a first positioning and mounting part; 305. a second positioning and mounting part; 306. a jack; 307. a first fixing hole; 4. a charging coil; 40. an open slot; 41. a first lead terminal; 42. a second lead terminal; 5. an antenna; 6. an electrode lead; 7. tabletting; 8. the skull; 81. bone cement; 9. installing a shell; 91. mounting a lug; 92. a screw; 93. bending the pressing plate; 100. a pulse generator; 200. an extracorporeal control device; 300. and (4) a fixing device.
Detailed Description
The technical solution of the present invention is described in detail below with reference to the accompanying drawings.
Example 1
The present embodiment provides a pulse generator disposed on one side of a wiring slot, as shown in fig. 1 to 3, including: a top cover member 1 including a top cover body 11, and two electrode connecting means 3 (in the present embodiment, two electrode connecting means 3 are provided, namely, a first electrode connecting means 31 and a second electrode connecting means 32) installed inside the top cover body 11; a body part 2 including a case 21, a circuit board (not shown in the drawings) mounted inside the case 21, and feed-through leads 22 electrically connected to the circuit board; the feed-through lead 22 is inserted into the top cover part 11 and electrically connected to the electrode connecting device 3; the two electrode connecting devices 3 are arranged inside the top cover body 11 and are arranged in parallel towards the direction away from the main body part 2. The feed-through leads 22 are of two types, one straight and short in fig. 2 for electrical connection to the first electrode connection means 31 and the other bent and long in fig. 2 for electrical connection to the second electrode connection means 32.
The pulse generator of the embodiment adjusts the arrangement mode of the electrode connecting device 3 in the top cover part 1, reduces the thickness of the top cover part 1, and further reduces the thickness of the whole pulse generator. The pulse generator adopting the structure is lighter and thinner, the depth of the bone groove formed on the skull is shallower, the pain of a patient is less, and the operation safety is higher.
As shown in fig. 5, the electrode connecting device 3 includes a plurality of connectors 301 (4 connectors in this embodiment), an insulating ring 302 (4 connectors in this embodiment) is disposed between two adjacent connectors 301, the plurality of connectors 301 are respectively used for contacting and connecting with different connection positions of the insertion end of the electrode lead 6 to send stimulation signals to different contacts of the electrode lead 6, and the connectors 301 are provided with wiring slots 303; the wiring grooves 303 of all the electrode connecting devices 3 are disposed toward the same side of the top cover member 1. All of which are shown in fig. 5 as facing forward of the page.
The above arrangement of the electrode connecting device 3 with the wiring groove facing one side allows the feed-through wires 22 to be conveniently and intensively extended from one side of the main body part 2 to the inside of the top cover part 1, enter the wiring groove 303 and be electrically connected with the connector 301, thereby reducing the connection interference of each component inside the top cover part 1 and facilitating the thickness reduction of the top cover part 1.
Correspondingly, the feed-through lead 22 extends from the housing 21 and the connection groove 303 to the same side recess 18, and then is inserted into the top cover component 1 to be electrically connected with the connection groove 303, the charging coil 4 and the antenna 5. The concentrated outgoing lines from one side of the feed-through wires 22 extend to the top cover member 1 from different positions, thereby avoiding the problem of complicated wiring and wiring caused by outgoing lines from the side of the main body member 2 facing the top cover member 1 and facilitating the thinning and manufacturing of the main body member 2. The feed-through wires 22 are only required to be concentrated from the recess 18 on one side of the body 2, and how closely they are arranged inside the body 2 does not affect the subsequent electrical connection with the top cover 1, thus facilitating the compactness of design and manufacture.
As shown in fig. 5, a plurality of first limiting grooves 101 are formed in the top cover member 1, the first limiting grooves 101 are opposite to the wiring grooves 303 of the electrode connecting device 3 (i.e. the first electrode connecting device 31 shown in the figure) closest to the main body member 2, and a portion of the feed-through lead 22 passes through the first limiting grooves 101 and then directly extends into the wiring grooves 303 of the first electrode connecting device 31 to be connected with the connector 301. Thus, after the feed-through leads 22 extend from the main body 2, the feed-through leads directly enter the inside of the wiring groove 303 through the first limiting groove 101 to realize electric connection, and the circuit is short and hardly occupies the internal space of the top cover part 1.
The top cover member 1 is further provided with a plurality of second limiting grooves 102, the second limiting grooves 102 are not directly opposite to the connectors 301 of the first electrode connecting devices 31, and another part of the feed-through lead 22 passes through the second limiting grooves 102, then enters between two adjacent electrode connecting devices 3 by winding the insulating ring 302, and then enters into the wiring grooves 303 of other electrode connecting devices 3 (such as the second electrode connecting devices 32 shown in the figure) which are not closest to the main body member 2, and is connected with the connectors 301. In this arrangement, another portion of the feedthrough lead 22, after exiting the second limiting recess 102, is substantially directly opposite the insulating ring 302 (or may be located elsewhere in proximity to the connector 301) and avoids electrical communication with the connector 301 of the first electrode connection assembly 31; the partial feed-through lead 22 is tightly pressed between the insulating ring 32 and the inner wall of the top cover main body 11 when the electrode connecting device 3 is fixed by winding the partial feed-through lead through the insulating ring 302 and then entering between two adjacent electrode connecting devices 3 (namely, the first electrode connecting device 31 and the second electrode connecting device 32 shown in the figure), so that the wiring manner makes full use of the gap space inside the top cover part 1, and the wiring is regular and firm.
As shown in fig. 6, the electrode connecting device 3 has a first positioning mounting part 304 and a second positioning mounting part 305, and a mounting position 12 for positioning and mounting the first positioning mounting part 304 and the second positioning mounting part 305 is provided in the top cover body 1; the connector 301 and the insulating ring 302 are disposed between the first and second positioning and mounting portions 304 and 305. The first positioning and mounting portion 304 and the second positioning and mounting portion 305 are positioned and mounted inside the top cover body 11, so that the whole electrode connecting device 3 can be positioned and mounted, and the rest of the space can provide a wiring path for the feed-through lead 22.
As shown in fig. 4, 6, 8 and 9, the second positioning and mounting portion 305 is provided with a first fixing hole 307 communicating with an insertion hole 306 of the electrode connecting device 3 for inserting and mounting the electrode lead 6; a second fixing hole 13 is formed on the top cover body 11 opposite to the first fixing hole 307; an elastic cap 14 is installed at the second fixing hole 13, a normally closed opening 15 is formed in the elastic cap 14, the second fixing hole 13 is located in a groove 106 of the top cover body 11, and the groove 19 is used for filling sealant around the elastic cap 14; and a fixing bolt screwed with the first fixing hole 307 through the second fixing hole 13 for pressing the electrode lead 6 inserted into the insertion hole 306. When the electrode lead wire fixing device is used specifically, a tool is used for penetrating through the normally closed opening 15 of the elastic cap 14, matching with the fixing bolt, screwing the fixing bolt to rotate, and extending and retracting relative to the first fixing hole 307, so that the electrode lead wire 6 extending into the jack 306 is fastened or released.
As shown in fig. 4 and 7, a containing groove 16 for containing and installing the charging coil 4 is provided on one side of the top cover body 11 away from the electrode connecting device 3; an opening groove 40 for allowing the charging coil 4 to penetrate out to be connected with the main body part 2 is formed in one side, facing the main body part 2, of the accommodating groove 16. The charging coil 4 is arranged at the position, and the position faces outwards after the pulse generator is implanted into a human body, so that the pulse generator is convenient to charge in cooperation with an external charger; the open slot 40 provides a line path for the power supply coil 4 to communicate with the body part 2.
Further, the charging coil 4 position uses the silicon rubber cladding, not only can fix charging coil 4, can not produce interference such as vortex moreover when charging, is favorable to promoting charge efficiency.
As shown in fig. 4-6, the electrode connecting device further includes an antenna 5 disposed in a mounting gap 17 formed between an end of the top cover body 11 away from the main body 2 and the electrode connecting device 3. This kind of mounting means make full use of the installation space of top cap body 1, and be favorable to antenna 5 and external signal interaction.
As shown in fig. 4, a recess 103 is formed in an outer wall of an end of the top cover body 11 away from the main body 2, and a fixed pressing plate 104 is disposed inside the recess 103. As shown in fig. 10, after the pulse generator is mounted on the skull of a human body, one end of the pressing sheet 7 is fixed by using a screw at the position of the skull opposite to the groove 103, and the other end of the pressing sheet 7 is pressed at the position of the fixed pressing plate 104, so that the pulse generator is fixed.
In this embodiment, the top cover member 1 and the main body member 2 are fixedly connected by sleeving and clamping, as shown in fig. 2, one end of the main body member 2 facing the top cover member 1 is provided with three pin shafts 23, the bottom of the top cover member 1 is provided with a cavity for inserting the end of the main body member 2, the inner wall of the corresponding position of the cavity is provided with a pin shaft hole 105, when the top cover member 1 and the main body member 2 are assembled, the end of the main body member 2 extends into a part of the bottom cavity of the top cover member 1, and then the three pin shafts 23 penetrate out from the positions of the three corresponding pin shaft holes 105 respectively, so that the fixed clamping can be completed.
In this embodiment, the pulse generator is installed inside the bone groove of the skull 8 through the installation device, specifically as shown in fig. 10, the installation housing 9 is first placed inside the bone groove, the installation lug 91 on the installation housing 9 is provided with an installation hole, and the installation housing 9 is screwed into the skull 8 from the installation hole position by using the screw 92, so as to complete the fixed installation of the installation housing 9; then the pulse generator is placed inside the installation shell 9, one end of the installation shell 9 is provided with a bending pressing plate 93, an installation space is formed between the bending pressing plate 93 and the installation shell 9, one end of the pulse generator extends into the installation space and is fixed by the installation shell 9 and the bending pressing plate 93 in a pressing mode, the other end of the pulse generator is provided with the groove 103 and one end of the fixing pressing plate 104, one end of the pressing plate 7 is fixed on the skull bone through screws, the other end of the pressing plate 7 is pressed at the position of the fixing pressing plate 104, and therefore the other end of the pulse generator is fixed, and people can install the pulse generator inside the skull bone. In the pulse generator of this embodiment, after the installation is completed, the first electrode connecting device 31 and the second electrode connecting device 32 are arranged in the bone groove in a non-overlapping and flat manner, and the depth of the bone groove is shallow.
Example 2
The present embodiment provides a pulse generator with a wiring slot disposed on both sides, including: the top cover component 1 comprises a top cover body 11 and an electrode connecting device 3 arranged inside the top cover body 11; a body member 2 including a case 21, a circuit board mounted inside the case 21, and a feed-through lead 22 electrically connected to the circuit board; the feed-through lead 22 is inserted into the top cover part 11 and electrically connected to the electrode connecting device 3; two electrode connecting devices 3 are arranged inside the top cover body 11 and are arranged in parallel towards the direction far away from the main body component 2; the electrode connecting device 3 comprises a plurality of connectors 301, an insulating ring 302 is arranged between every two adjacent connectors 301, and each connector 301 is provided with a wiring groove 303; a wiring groove 303 of one of the electrode connecting means 3 is provided toward one side of the top cover member 1; the wiring groove 303 of the other of the electrode connecting means 3 is provided toward the other side of the top cover member 1.
The pulse generator of the embodiment adjusts the arrangement mode of the electrode connecting device 3 in the top cover part 1, reduces the thickness of the top cover part 1, and further reduces the thickness of the whole pulse generator. The wiring groove 303 of one electrode connecting device 3 is provided toward one side of the top cover member 1, and the wiring groove 303 of the other electrode connecting device 3 is provided toward the other side of the top cover member 1, so that the feed-through lead 22 is conveniently extended from one side of the body member 2 to the inside of the top cover member 1, and then directly enters the wiring groove 303 to be electrically connected with the connector 301, thereby being capable of reducing the thickness of the top cover member 1. The pulse generator of the embodiment is lighter and thinner, the depth of the bone groove formed in the skull is shallower, the pain of a patient is less, and the operation safety is higher.
The feed-through conductors 22 project from the side of the housing 21 facing the cover part 1 and are inserted into the cover part 1 and are electrically connected to the corresponding terminal grooves 303.
One side of top cap part 1 is equipped with a plurality of first spacing grooves 101, first spacing groove 101 with one the wiring groove 303 of electrode connecting device 3 is just right, partly the lead wire feed-through 22 passes directly stretch into one behind the first spacing groove 101 electrode connecting device 3 the wiring groove 303 inside with connector 301 is connected.
The other side of the top cover component 1 is provided with a plurality of second limiting grooves 102, the second limiting grooves 102 are opposite to the connector 301 of the other electrode connecting device 3, and the other part of the feed-through lead 22 passes through the second limiting grooves 102 and then enters the wiring groove 303 of the other electrode connecting device 3 to be connected with the connector 301.
The electrode connecting device 3 is provided with a first positioning installation part 304 and a second positioning installation part 305, and an installation position 12 for positioning and installing the first positioning installation part 304 and the second positioning installation part 305 is arranged in the top cover body 1; the connector 301 and the insulating ring 302 are disposed between the first and second positioning and mounting portions 304 and 305.
The second positioning and mounting part 305 is provided with a first fixing hole 307 communicated with an insertion hole 306 of the electrode connecting device 3 for inserting and mounting the electrode lead 6; a second fixing hole 13 is formed on the top cover body 11 opposite to the first fixing hole 307; an elastic cap 14 is arranged at the position of the second fixing hole 13, and a normally closed opening 15 is formed in the elastic cap 14; and a fixing bolt passing through the second fixing hole 13 and then screwed with the first fixing hole 307, for tightly pressing the electrode lead 6 inserted into the insertion hole 306.
When the electrode lead wire fixing device is used specifically, a tool is used for penetrating through the normally closed opening 15 of the elastic cap 14, matching with the fixing bolt, screwing the fixing bolt to rotate, and extending and retracting relative to the first fixing hole 307, so that the electrode lead wire 6 extending into the jack 306 is fastened or released.
And a containing groove 16 for containing and installing the charging coil 4 is arranged on one side surface of the top cover body 11 far away from the electrode connecting device 3. The charging coil 4 is arranged at the position, and the position faces outwards after the pulse generator is implanted into the human body, so that the pulse generator is convenient to charge in cooperation with an external charger.
The 4 positions of the charging coils are coated with silicon rubber, so that the charging coils 4 can be fixed, and the charging efficiency can be improved without generating interference such as vortex when charging.
The electrode connecting device further comprises an antenna 5 which is arranged at one end, far away from the main body part 2, of the top cover body 11 and is arranged in a mounting gap 17 formed between the antenna and the electrode connecting device 3, the mounting space of the top cover body is fully utilized by the assembling mode, and signal interaction between the antenna and the outside is facilitated.
Example 3
The present embodiment provides an implantable neurostimulation system, as shown in fig. 17, which includes: a pulse generator 100; an electrode lead 6 having a connection contact for connection with the pulse generator at one end and a stimulation contact adapted for connection with a nerve at the other end; a fixture 300 for fixing the electrode lead 6 to the skull; an extracorporeal control apparatus 200 capable of wireless communication with the pulse generator; the pulse generator is the pulse generator described in embodiment 1 or embodiment 2.
The implantable neurostimulation system of the embodiment adopts the pulse generator in the embodiment 1 or the embodiment 2, so that the implantable neurostimulation system has all the advantages brought by the adoption of the pulse generator, such as good lightness and thinness, high charging efficiency and the like.
Fig. 18 is a schematic view of an implantation procedure of the implantable neurostimulation system of the present invention. Firstly, step s00 is carried out, the skull is holed according to the traditional method, the stimulating electrode is implanted and the electrode is fixed, and step s01 is carried out after the electrode is tested to be normal; cutting the scalp at the position where the pulse generator 100 is installed to expose the skull, and preparing a skull bone groove according to the shape of the pulse generator 100; then step s02 is performed, placing the pulse generator mounting housing 9 and fixing to the skull bone; then, step s03 is performed to create a subcutaneous tunnel between the pulse generator incision and the electrode incision, and the connection end of the electrode lead 6 is passed through the subcutaneous tunnel to the implantation site of the pulse generator 100, and the excess electrode lead 6 may be wound several turns around the electrode holding fixture 300. Then step s04 is executed, the electrode and the pulse generator 100 are connected and locked; then, step s05 is executed to fix the pulse generator 100 to the mounting case 9. Finally, step s06 is executed, the implantation system is tested by the in vitro program controller, and the incision is sutured after the test is normal, thereby completing the implantation.
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.
Claims (10)
1. A wire slot double-sided disposed pulse generator comprising:
the top cover component (1) comprises a top cover body (11) and an electrode connecting device (3) arranged inside the top cover body (11);
a body part (2) comprising a housing (21), a circuit board mounted inside the housing (21), and feed-through leads (22) electrically connected to the circuit board; the feed-through lead (22) is inserted into the top cover component (11) and electrically connected with the electrode connecting device (3);
the method is characterized in that: the two electrode connecting devices (3) are arranged inside the top cover body (11) and are arranged in parallel towards the direction far away from the main body component (2);
the electrode connecting device (3) comprises a plurality of connectors (301), an insulating ring (302) is arranged between every two adjacent connectors (301), and wiring grooves (303) are formed in the connectors (301);
a wiring groove (303) of one of the electrode connecting devices (3) is arranged towards one side of the top cover part (1);
the connection groove (303) of the other electrode connection device (3) is arranged toward the other side of the top cover component (1).
2. A pulse generator as defined in claim 1, wherein: the feed-through conductors (22) project from the housing (21) on the side facing the cover part (1) and are inserted into the cover part (1) and are each electrically connected to a respective terminal groove (303).
3. A pulse generator as defined in claim 2, wherein: one side of top cap part (1) is equipped with a plurality of first spacing grooves (101), first spacing groove (101) and one wiring groove (303) of electrode connecting device (3) are just right, partly feedthrough wire (22) pass directly stretch into one behind first spacing groove (101) electrode connecting device (3) inside with connector (301) are connected.
4. A pulse generator as defined in claim 2, wherein: the other side of the top cover component (1) is provided with a plurality of second limiting grooves (102), the second limiting grooves (102) are opposite to the connector (301) of the other electrode connecting device (3), and the other part of the feed-through lead (22) passes through the second limiting grooves (102) and then enters the other wiring groove (303) of the electrode connecting device (3) to be connected with the connector (301).
5. A pulse generator as defined in any of claims 2-4, wherein: the electrode connecting device (3) is provided with a first positioning installation part (304) and a second positioning installation part (305), and an installation position (12) for positioning and installing the first positioning installation part (304) and the second positioning installation part (305) is arranged in the top cover body (1); the connector (301) and the insulating ring (302) are disposed between the first positioning mount (304) and the second positioning mount (305).
6. A pulse generator as defined in claim 5, wherein: the second positioning installation part (305) is provided with a first fixing hole (307) communicated with an insertion hole (306) of the electrode connecting device (3) for inserting and installing an electrode lead (6);
a second fixing hole (13) is formed in the top cover body (11) opposite to the first fixing hole (307);
an elastic cap (14) is arranged at the position of the second fixing hole (13), and a normally closed opening (15) is formed in the elastic cap (14);
and the fixing bolt penetrates through the second fixing hole (13) and then is in threaded connection with the first fixing hole (307) and is used for tightly extruding the electrode lead (6) inserted into the insertion hole (306).
7. A pulse generator as defined in any of claims 2-4, wherein: and a containing groove (16) for containing and installing the charging coil (4) is formed in one side surface, far away from the electrode connecting device (3), of the top cover body (11).
8. The pulser of claim 7, wherein: the position of the charging coil (4) is coated by silicon rubber.
9. A pulse generator as defined in any of claims 2-4, wherein: the electrode connecting device further comprises an antenna (5) which is arranged at one end of the top cover body (11) far away from the main body component (2) and inside a mounting gap (17) formed between the antenna and the electrode connecting device (3).
10. An implantable neurostimulation system comprising:
a pulse generator;
an electrode lead (6) having a connection contact (61) at one end for connection with the pulse generator and a stimulation contact (62) at the other end adapted for connection with a nerve;
a fixation means for fixing the electrode lead (6) to the skull;
an extracorporeal control device capable of wireless communication with the pulse generator;
the method is characterized in that:
the pulse generator is according to any one of claims 1-9.
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CN202010504854.9A CN111744109B (en) | 2020-06-05 | Pulse generator and implanted nerve stimulation system with wiring grooves arranged on two sides |
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CN202010504854.9A CN111744109B (en) | 2020-06-05 | Pulse generator and implanted nerve stimulation system with wiring grooves arranged on two sides |
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CN111744109A true CN111744109A (en) | 2020-10-09 |
CN111744109B CN111744109B (en) | 2024-10-29 |
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