CN216258739U - Implantable medical device and medical lead thereof - Google Patents

Implantable medical device and medical lead thereof Download PDF

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Publication number
CN216258739U
CN216258739U CN202122510621.2U CN202122510621U CN216258739U CN 216258739 U CN216258739 U CN 216258739U CN 202122510621 U CN202122510621 U CN 202122510621U CN 216258739 U CN216258739 U CN 216258739U
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medical lead
strand
medical
wires
strands
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CN202122510621.2U
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Chinese (zh)
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徐周东
吴国良
章海涛
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Jingyu Medical Technology Suzhou Co ltd
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Sceneray Co Ltd
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Priority to PCT/CN2022/124366 priority patent/WO2023066065A1/en
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    • 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
    • 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
    • A61N1/372Arrangements in connection with the implantation of stimulators

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

Abstract

The utility model provides an implantable medical device and a medical lead thereof, which are suitable for the implantable medical device, wherein the medical lead comprises: the medical lead comprises at least two strands which are spirally wound together along the axial direction of the medical lead; wherein, at least two guide wires are twisted to form a strand of stranded wire. On one hand, when the number of the guide wires is increased, the diameter of the medical lead is not obviously changed and can be strictly controlled, so that the damage caused by invasion operation is avoided, and the space utilization rate is high; on the other hand, the pitch between the spiral coils of each strand of stranded wire in the medical lead is reduced, the medical lead has better flexibility and stretchability, and the foreign body sensation of implantation is reduced.

Description

Implantable medical device and medical lead thereof
Technical Field
The utility model belongs to the technical field of implantable medical devices, and particularly relates to an implantable medical device and a medical lead thereof.
Background
The implantable electrical stimulator may be used to deliver electrical stimulation therapy to a patient to treat various symptoms or conditions, such as chronic pain, tremor, parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. Typically, implantable electrical stimulators deliver neural stimulation therapy in the form of electrical pulses, such as via one or more leads that include electrodes positioned near target tissue of the patient's brain, spinal cord, pelvic nerve, peripheral nerve, or stomach. Thus, stimulation output by the implantable electrical stimulator may be used for different therapeutic applications, such as Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve stimulation. Additionally, stimulation may also be used for muscle stimulation, such as Functional Electrical Stimulation (FES) to promote muscle movement or to prevent atrophy.
Existing implantable electrical stimulators typically include a stimulator (e.g., a pulse generator), one or more leads, and a stimulation electrode connected to the leads. The stimulation electrodes are in contact with or in proximity to the neuromuscular or other tissue in need of stimulation. A pulse generator in the stimulator generates electrical pulses that are delivered by the electrodes to the body tissue. The lead, among other things, generally includes an elongated, flexible insulator and one or more filaments extending within a lumen within the insulator, the one or more filaments being helically wound to form a coil. Because the lead is implanted into a human body, the lead needs to have better flexibility and stretchability, so that the foreign body sensation during implantation is reduced. While avoiding damage from invasive procedures, the diameter of the wire needs to be tightly controlled.
Disclosure of Invention
The utility model aims to provide an implantable medical device and a medical lead thereof, wherein the medical lead has excellent flexibility and stretchability.
The technical scheme of the utility model provides a medical lead which is suitable for an implanted medical apparatus, and comprises: the medical lead comprises at least two strands which are spirally wound together along the axial direction of the medical lead; wherein, at least two guide wires are twisted to form a strand of stranded wire.
As an optional technical scheme, the at least two strands of stranded wires include a first strand of stranded wires and a second strand of stranded wires, wherein at least a first number of guide wires are stranded to form a first strand of stranded wires, and at least a second number of guide wires are stranded to form a second strand of stranded wires; wherein the first number and the second number are the same or different.
As an optional technical scheme, the at least two strands of stranded wires include four strands of stranded wires, each strand of stranded wires in the four strands of stranded wires includes three guide wires, and the three guide wires are stranded to form one stranded wire.
As an optional technical scheme, the number of the guide wires in each strand of stranded wire is 2-4.
As an optional technical solution, the total number of the guide wires in the medical lead is 4-20.
As an optional technical solution, the diameter of each guide wire is 0.05-0.2 mm.
As an optional technical scheme, the number of the guide wires in each strand of stranded wire is 2-4, and the total number of the guide wires in the medical guide wire is 8-16.
As an optional technical solution, the medical lead further includes an insulating layer, the insulating layer surrounds the at least two strands, and the insulating layer covers the outer portions of the at least two strands, and as an optional technical solution, the insulating layer is a polymer insulating layer.
The utility model also provides an implantable medical device which transmits electrical stimulation through the medical lead.
As an optional technical solution, the implantable medical device includes a stimulation electrode, a medical lead, and a stimulator, wherein one end of each guide wire in the lead structure is electrically connected to the stimulation electrode, and the other end of each guide wire opposite to the other end is electrically connected to the stimulator.
Compared with the prior art, the utility model provides an implantable medical device and a medical lead thereof, wherein a plurality of guide wires are stranded to form a stranded wire, and a plurality of stranded wires are spirally wound to form the medical lead; on the other hand, the pitch between the spiral coils of each strand of stranded wire in the medical lead is reduced, the medical lead has better flexibility and stretchability, and the foreign body sensation of implantation is reduced.
The utility model is described in detail below with reference to the drawings and specific examples, but the utility model is not limited thereto.
Drawings
Fig. 1 is a schematic view of a medical lead provided in a first embodiment of the present invention.
Fig. 2 is a schematic view of the medical lead of fig. 1 from another perspective.
Fig. 3 is a schematic view of each strand of the wire for chinese medical use of fig. 1.
Fig. 4 is a schematic view of a medical lead provided in a second embodiment of the present invention.
Fig. 5 is a schematic view of the medical lead of fig. 4 from another perspective.
Detailed Description
Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and thus their repetitive description will be omitted.
The words expressing the position and direction described in the present invention are illustrated in the accompanying drawings, but may be changed as required and still be within the scope of the present invention.
The utility model aims to provide an implantable medical device and a medical lead thereof, wherein the medical lead is suitable for the implantable medical device and comprises: at least two strands spirally wound along the axial direction of the medical lead; wherein, at least two guide wires are twisted to form a strand of stranded wire.
In the medical leads with the same number of leads, at least two leads are twisted in advance to form a strand of stranded wire; two or more strands are spirally wound together to form the medical lead, on one hand, the number of the leads is increased, the diameter of the prepared medical lead is not obviously changed, the diameter of the medical lead can be strictly controlled, and the space utilization rate is high; on the other hand, a plurality of guide wires are twisted in advance to form stranded wires, and then the stranded wires are spirally wound by the stranded wires, so that the thread pitch between the spiral rings formed by each stranded wire is reduced, the flexibility and the stretchability of the prepared medical lead are obviously improved, and when the flexibility and the stretchability are high, particularly when the medical lead is implanted into the neck of a person, the foreign body implantation feeling of the medical lead can be obviously reduced, and the medical lead is of great significance for improving the experience of a patient. The thread pitch is the distance between the centers of any two of the plurality of coils formed by each strand of stranded wire along the axial direction of the medical lead.
In this embodiment, at least two guide wires are stranded to support one strand of stranded wire, and each strand of stranded wire is preferably a linear stranded wire.
In addition, experimental studies show that, in medical leads with the same number of guide wires, the larger the number of guide wires in each strand of stranded wire (for example, the number of guide wires is greater than or equal to 2), when a plurality of strands of stranded wires are spirally wound, the space utilization rate in the axial direction is reduced, the pitch between each strand of stranded wires is reduced, and the flexibility and the stretchability of the medical leads are better; however, the smaller the number of the guide wires in each strand (for example, the minimum number of the guide wires is 1), the more the plurality of strands are spirally wound, the higher the space utilization rate in the axial direction is, but the pitch between each strand is increased, and the poorer the flexibility and stretchability of the medical wire is.
In a preferred embodiment, the number of wires in each strand is 2-4, preferably 3, and the strand structure is verified to achieve a good balance between space efficiency, flexibility and stretchability.
In a preferred embodiment, the total number of the guide wires in the medical lead is 4-20, and the medical leads with different guide wires can be manufactured according to the requirement, so that the electrical connection requirement of most stimulation electrodes is met.
In a preferred embodiment, the at least two strands comprise a first strand and a second strand, such that at least a first number of the guide wires are twisted to form a first strand and at least a second number of the guide wires are twisted to form a second valley strand; wherein the first number and the second number are the same or different.
It should be noted that the above-mentioned "first" and "second" are only used for distinguishing and describing different strands and are not limited to the specific number of strands in the medical lead. That is, in other embodiments of the present invention, the at least two strands may further include a third strand, a fourth strand, a fifth strand, and the like.
In other words, each strand of the at least two strands may include the same number of guide wires, the same number of guide wires are twisted to form the same strand, and the same strand is spirally wound together to form the medical lead; or when the at least two strands are two strands, each strand may include different numbers of guide wires, and the different numbers of guide wires are twisted to form different strands, and the different strands are spirally wound together to form the medical lead; or when the at least two strands of stranded wires are three or more strands of stranded wires, the two strands of stranded wires or each strand of stranded wires can also respectively comprise guide wires with different numbers, the guide wires with different numbers are respectively stranded to form different stranded wires, and the different stranded wires are spirally wound together to form the medical lead.
That is, in the actual operation process, the number of the guide wires in each strand of the stranded wire can be selected according to the actual requirement, and whether the number of the guide wires in any two strands of the stranded wire is the same or not can also be selected according to the actual requirement.
In a preferred embodiment, the diameter of each guide wire is 0.05-0.2mm, and the diameter of the medical guide wire formed by the guide wires with the diameter is small, and particularly when the number of the guide wires in each strand of stranded wire is 2-4 and the total number of the guide wires is 8-16, the medical guide wire made of the guide wires with the diameter simultaneously has better space utilization rate, flexibility and stretchability.
In a preferred embodiment, the medical lead comprises an insulating layer disposed around and covering at least two strands. Preferably, the insulating layer is a polymer insulating layer, and the insulating layer is preferably made of a material with good biocompatibility.
As shown in fig. 1 and 2, in the first embodiment of the present invention, the medical lead 100 includes 4 strands, and 4 strands are helically wound, wherein each strand is formed by twisting 3 guide wires.
Specifically, the first strand of the 4 strands includes 3 first wires 11, 12, 13, and the 3 first wires 11, 12, 13 are previously twisted; the second strand of the 4 strands comprises 3 second guide wires 21, 22 and 23, and the 3 second guide wires 21, 22 and 23 are pre-twisted; the third strand of the 4 strands comprises 3 third guide wires 31, 32 and 33, and the 3 third guide wires 31, 32 and 33 are pre-twisted; the fourth strand of the 4 strands includes 3 fourth wires 41, 42, 43, and the 3 fourth wires 41, 42, 43 are previously twisted.
And then the first strand of stranded wire, the second strand of stranded wire, the third strand of stranded wire and the fourth strand of stranded wire are spirally wound together to obtain the medical lead 100.
In this embodiment, 3 guide wires are twisted to form a stranded wire, and then 4 stranded wires are spirally wound to form the medical lead 100, so that the medical lead has better flexibility and stretchability and high space utilization rate. In addition, on the premise that the total number of the guide wires in the medical lead is the same, the diameter of the medical lead 100 obtained by pre-twisting 3 guide wires and then spirally winding the twisted guide wires is not obviously different from the diameter of the medical lead 300 (shown in fig. 4) obtained by directly spirally winding 12 guide wires. Namely, a plurality of guide wires are stranded to form a stranded wire, and the diameter of the medical lead after being spirally wound cannot be increased, so that the diameter of the medical lead can be strictly controlled, and meanwhile, the flexibility and the stretchability of the medical lead are increased.
As shown in fig. 4 and 5, a medical lead 300 is provided in a second embodiment of the present invention.
The medical lead 300 is formed by spirally winding 12 guide wires 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312 together.
Since the 12 guide wires are spirally wound to form a single-layer coil, the space utilization of the guide wires increases in the axial direction of the medical wire 300, but the pitch between the coils formed by each guide wire increases, resulting in a decrease in the flexibility of the medical wire 300.
Since the 12 guide wires are spirally wound to form a single-layer coil, the diameter of the medical wire 300 is substantially the same as the diameter of the outer-layer coil of the medical wire 200, and the diameter of the medical wire 100 is substantially the same.
In addition, compared to the medical lead shown in fig. 4 and 5, when the medical lead 100 formed by at least two strands is connected to the connection device, the guide wire in the medical lead 100 is more convenient to be connected to the channel connector in the connection device of the medical lead 100, and the connection device is used for connecting the stimulation electrodes. Specifically, referring to fig. 5, it can be seen at the end surface of the medical lead 300 in fig. 5 that the positions of the ends of the 12 guide wires are relatively dispersed, and thus, the wiring is more complicated when connecting with the channel connector in the connecting device. At one end of the medical lead 100 shown in fig. 2, the end portions of the 12 guide wires are more concentrated, and the wiring is more convenient when the medical lead is connected with a channel connector in the connecting device.
The utility model also provides an implantable medical device which delivers electrical stimulation through at least one of the medical leads 100, 200, 300.
In a preferred embodiment, one end of each wire of the medical lead is electrically connected to the stimulation electrode, and the opposite end of each wire is electrically connected to the stimulator. The stimulator outputs an electrical stimulation signal, the electrical stimulation signal is transmitted to the stimulation electrode through the guide wire, and the stimulation electrode outputs electrical stimulation to act on the target position. In one embodiment, the implantable medical device includes a stimulation electrode, a medical lead, and a stimulator, wherein one end of each of the leads is electrically connected to the stimulation electrode and an opposite end of each of the leads is electrically connected to the stimulator.
In summary, the utility model provides an implantable medical device and a medical lead thereof, wherein a plurality of guide wires are twisted to form a stranded wire, and a plurality of stranded wires are spirally wound to form the medical lead, so that on one hand, when the number of the guide wires is increased, the diameter of the medical lead is not obviously changed, the diameter can be strictly controlled, the damage caused by invasion operation is avoided, and the space utilization rate is high; on the other hand, the pitch between the spiral coils of each strand of stranded wire in the medical lead is reduced, the medical lead has better flexibility and stretchability, and the foreign body sensation of implantation is reduced.
Although embodiments of the present invention have been shown and described, it will be understood that the above embodiments are exemplary and not to be construed as limiting the present invention, and that those skilled in the art may make changes, modifications, substitutions and alterations to the above embodiments without departing from the spirit and scope of the present invention, all such changes being within the scope of the appended claims.

Claims (10)

1. A medical lead adapted for use with an implantable medical device, the medical lead comprising:
the medical lead comprises at least two strands which are spirally wound together along the axial direction of the medical lead;
wherein, at least two guide wires are twisted to form a strand of stranded wire.
2. The medical lead of claim 1, wherein the at least two strands comprise a first strand and a second strand, at least a first number of the wires stranded to form the first strand and at least a second number of the wires stranded to form the second strand; wherein the first number and the second number are the same or different.
3. The medical lead of claim 1, wherein the at least two strands comprise four strands, each of the four strands comprising three wires, the three wires being twisted to form one strand.
4. The medical lead of claim 1, wherein the number of guide wires in each strand is 2-4.
5. The medical lead of claim 4, wherein the total number of guidewires in the medical lead is 4-20.
6. The medical lead of claim 1, wherein each wire has a diameter of 0.05-0.2 mm.
7. The medical lead of claim 6, wherein the number of the guide wires in each strand is 2-4 and the total number of the guide wires in the medical lead is 8-16.
8. The medical lead of claim 1, further comprising an insulating layer disposed around the at least two strands, the insulating layer covering an exterior of the at least two strands.
9. An implantable medical device, wherein the implantable medical device delivers electrical stimulation through the medical lead of any one of claims 1-8.
10. The implantable medical device according to claim 9, wherein said implantable medical device comprises a stimulation electrode, a medical lead and a stimulator, one end of each of said leads being electrically connected to said stimulation electrode and the opposite end of each of said leads being electrically connected to said stimulator.
CN202122510621.2U 2021-10-19 2021-10-19 Implantable medical device and medical lead thereof Active CN216258739U (en)

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CN202122510621.2U CN216258739U (en) 2021-10-19 2021-10-19 Implantable medical device and medical lead thereof
PCT/CN2022/124366 WO2023066065A1 (en) 2021-10-19 2022-10-10 Implantable medical device and medical wire thereof

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CN202122510621.2U CN216258739U (en) 2021-10-19 2021-10-19 Implantable medical device and medical lead thereof

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114847955A (en) * 2022-07-05 2022-08-05 诺尔医疗(深圳)有限公司 Method for manufacturing electroencephalogram and electroencephalogram
WO2023056762A1 (en) * 2021-10-09 2023-04-13 上海神奕医疗科技有限公司 Electrical lead, processing method, extension line, electrode and electrical stimulation system
WO2023066065A1 (en) * 2021-10-19 2023-04-27 苏州景昱医疗器械有限公司 Implantable medical device and medical wire thereof

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JP2005185386A (en) * 2003-12-25 2005-07-14 Asahi Intecc Co Ltd Medical guide wire
US8560084B2 (en) * 2011-08-30 2013-10-15 Greatbatch Ltd. Lead body with inner and outer co-axial coils
CN104998351A (en) * 2015-08-18 2015-10-28 苏州培海精密机电科技有限公司 Wire arrangement guide pipe and multi-strand guide wire winding system applying same
CN205568943U (en) * 2016-03-28 2016-09-14 西安富德医疗电子有限公司 Medical five disposable stranded conductor pin electrodes
CN216258739U (en) * 2021-10-19 2022-04-12 苏州景昱医疗器械有限公司 Implantable medical device and medical lead thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023056762A1 (en) * 2021-10-09 2023-04-13 上海神奕医疗科技有限公司 Electrical lead, processing method, extension line, electrode and electrical stimulation system
WO2023066065A1 (en) * 2021-10-19 2023-04-27 苏州景昱医疗器械有限公司 Implantable medical device and medical wire thereof
CN114847955A (en) * 2022-07-05 2022-08-05 诺尔医疗(深圳)有限公司 Method for manufacturing electroencephalogram and electroencephalogram

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Address after: 215000 building C16, bio nano Park, 218 Xinghu street, Suzhou Industrial Park, Jiangsu Province

Patentee after: Jingyu Medical Technology (Suzhou) Co.,Ltd.

Address before: 215000 building C16, bio nano Park, 218 Xinghu street, Suzhou Industrial Park, Jiangsu Province

Patentee before: SCENERAY Co.,Ltd.

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