WO2023066065A1 - Implantable medical device and medical wire thereof - Google Patents

Abstract

The present application provides an implantable medical device and a medical wire thereof, being applicable to implantable medical devices. The medical wire comprises: at least two strands of twisted wires; the at least two strands of twisted wires are spirally wound along the axial direction of the medical wire; and the at least two strands of guide wires are twisted to form a strand of twisted wire. Multiple guide wires are twisted to form a twisted wire; multiple strands of twisted wires are spirally wound to form a medical wire; on the one hand, when the number of guide wires is increased, the diameter of the medical wire is not obviously changed and can be strictly controlled, damage caused by invasion operation is avoided, and the space utilization rate is high; and on the other hand, the screw pitch between coils of each twisted wire in the medical wire is reduced, such that the medical wire has better flexibility and stretchability, thereby reducing the foreign body sensation of implantation.

Description

Implantable medical devices and their medical leads

This application claims the priority of the Chinese patent with application number 202122510621.2 filed on October 19, 2021, which is incorporated by reference in its entirety.

technical field

The application belongs to the technical field of implantable medical devices, and in particular relates to implantable medical devices and medical leads thereof.

Background technique

Implantable electrical stimulators can be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremors, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity or gastroparesis . Typically, implantable electrical stimulators deliver neurostimulation therapy in the form of electrical pulses, such as via one or more leads that include targets located in the patient's brain, spinal cord, pelvic nerves, peripheral nerves, or stomach electrodes near the tissue. Therefore, the stimulation output by the implantable electrical stimulator can be used for different therapeutic applications, such as Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), Pelvic Stimulation, Gastric Stimulation or Peripheral Nerve Stimulation Stimulate. In addition, stimulation can also be used for muscle stimulation, such as Functional Electrical Stimulation (FES) to promote muscle movement or prevent atrophy.

Existing implantable electrical stimulators usually include a stimulator (such as a pulse generator), one or more wires and stimulating electrodes connected to the wires, and may also include a connector for connecting the pulse generator and the stimulating electrodes respectively. . The stimulating electrodes are in contact with or close to the neuromuscular or other tissues to be stimulated. The pulse generator produces electrical impulses that are delivered by the electrodes to body tissues. Wherein, the wire generally includes a slender, flexible insulator and one or more thin wires extending in the lumen of the insulator, and one or more thin wires are helically wound to form a coil. Since the wire is implanted into the human body, the wire needs to have better flexibility and stretchability to reduce the feeling of foreign body after implantation. At the same time to avoid damage caused by wire intrusion operations, the diameter of the wire needs to be strictly controlled.

Contents of the invention

The purpose of this application is to provide an implantable medical device and its medical lead, the medical lead has excellent flexibility and stretchability.

The technical solution of the present application provides a medical wire, which is suitable for implantable medical devices, and the medical wire includes: at least two twisted wires, and the at least two twisted wires are aligned along the axial direction of the medical wire Helically wound; wherein at least two guidewires are twisted to form a strand.

As an optional technical solution, the at least two stranded wires include a first stranded wire and a second stranded wire, at least a first number of guide wires are twisted to form the first stranded wire, at least a second number of guide wires Twisted to form a second twisted wire; wherein, the first number and the second number are the same or different.

As an optional technical solution, the at least two twisted wires include four twisted wires, each twisted wire in the four twisted wires includes three guide wires, and the three guide wires are twisted to form a twisted wire.

As an optional technical solution, the number of guide wires in each stranded wire is 2-4.

As an optional technical solution, the total number of guide wires in the medical guide wire is 4-20.

As an optional technical solution, the diameter of each guide wire is 0.05-0.2 mm.

As an optional technical solution, the number of guide wires in each twisted wire is 2-4, and the total number of guide wires in the medical wire is 8-16.

As an optional technical solution, the medical wire also includes an insulating layer, the insulating layer is arranged around the at least two twisted wires, and the insulating layer covers the outside of the at least two twisted wires, as a possible In the selected technical solution, the insulating layer is a polymer insulating layer.

The present application also provides an implantable medical device, which transmits electrical stimulation through the above-mentioned medical wire.

As an optional technical solution, the implantable medical device includes a stimulating electrode, a medical wire and a stimulator, one end of each guide wire in the wire structure is electrically connected to the stimulating electrode, and each guide wire opposite The other end is electrically connected to the stimulator; or,

The implantable medical device includes stimulating electrodes, medical wires, connectors and stimulators, one end of each guide wire of the medical wires is electrically connected to the stimulating electrodes, and the opposite end of each guide wire is electrically connected to the a connector that connects the stimulator via conductive wires; or,

The implantable medical device includes stimulating electrodes, medical wires, connectors and stimulators, one end of each guide wire of the medical wires is electrically connected to the stimulator, and the opposite end of each guide wire is electrically connected to the connector, so The above-mentioned connector connects the stimulating electrodes through conductive wires.

Compared with the prior art, this application proposes an implantable medical device and its medical wire. Multiple guide wires are twisted to form a stranded wire, and the multi-strand wires are helically wound to form a medical wire. On the one hand, when the number of guide wires increases, , the diameter of the medical wire does not change significantly, the space utilization rate is high, and it can be strictly controlled to avoid damage caused by intrusive operations; on the other hand, the pitch between the coils of each stranded wire in the medical wire decreases, and the medical wire It has better flexibility and stretchability, reducing the foreign body sensation of implantation.

The application will be described in detail below in conjunction with the accompanying drawings and specific embodiments, but it is not intended to limit the application.

Description of drawings

Fig. 1 is a schematic diagram of a medical lead provided in the first embodiment of the present application.

FIG. 2 is a schematic diagram of another viewing angle of the medical guide wire in FIG. 1 .

FIG. 3 is a schematic diagram of each twisted wire of the medical wire in FIG. 1 .

Fig. 4 is a schematic diagram of the medical lead provided in the second embodiment of the present application.

FIG. 5 is a schematic diagram of another viewing angle of the medical lead shown in FIG. 4 .

Detailed ways

Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many 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 denote the same or similar structures in the drawings, and thus their repeated descriptions will be omitted.

The words expressing position and direction described in the present invention are all described by taking the accompanying drawings as an example, but changes can also be made according to needs, and all changes are included in the protection scope of the present invention.

The purpose of this application is to provide an implantable medical device and its medical wire. The medical wire is suitable for the implantable medical device. Helically wound in a direction; wherein at least two guide wires are twisted to form a strand.

In medical leads with the same number of guide wires, at least two guide wires are pre-twisted to form a twisted wire; two or more strands of twisted wires are helically wound together to make a medical lead. On the one hand, As the number of guide wires increases, the diameter of the medical wires made will not change significantly, and the diameter of the medical wires can be strictly controlled, and the space utilization rate is high; The stranded wire is helically wound, so that the pitch between the coils formed by each stranded wire is reduced, and the flexibility and stretchability of the medical wire made are significantly increased. When the flexibility and stretchability are high, especially the medical wire When implanted in the neck of a person, it can significantly reduce the foreign body sensation of medical wire implantation, which is of great significance for improving the experience of patients. Wherein, the pitch refers to the distance between the centers of any two coils among the plurality of coils formed by each twisted wire along the axial direction of the medical wire.

In this embodiment, at least two guide wires are stranded to support a stranded wire, and each stranded wire is preferably a linear stranded wire.

In addition, experimental studies have shown that in medical leads with the same number of guide wires, the more guide wires there are in each strand (for example, the number of guide wires is greater than or equal to 2), the axial The space utilization rate in the direction decreases, the pitch between each twisted wire decreases, the better the flexibility and stretchability of the medical wire; however, the fewer the number of guide wires in each twisted wire (for example, guide wire The minimum number of wires is 1), when the multi-strand wires are helically wound, the space utilization rate in the axial direction increases, but the pitch between each strand increases, and the flexibility and stretchability of the medical wire become worse.

In a preferred embodiment, the number of guide wires in each twisted wire is 2-4, preferably 3, and it has been verified that the above-mentioned twisted wire structure can achieve a balance between space utilization, flexibility and stretchability. strike a better balance.

In a preferred embodiment, the total number of guide wires in the medical guide wire is 4-20, and medical guide wires with different numbers of guide wires can be manufactured according to the needs to meet the electrical connection requirements of most stimulating electrodes.

In a preferred embodiment, the at least two stranded wires comprise a first stranded wire and a second stranded wire, at least a first number of guide wires are twisted to form the first stranded wire, and at least a second number of guide wires are twisted to form the first stranded wire. Twisted to form a second strand; wherein the first number and the second number are the same or different.

It should be noted that the above "first" and "second" are only used to distinguish and describe different twisted wires and do not limit the specific number of twisted wires in the medical lead. That is, in other embodiments of the present application, the at least two twisted wires may also include a third twisted wire, a fourth twisted wire, a fifth wire, and the like.

In other words, each of the at least two twisted wires may include the same number of guide wires, the same number of guide wires are twisted to form the same twisted wire, and the same twisted wires are helically wound together to form a medical wire; or, at least When the two twisted wires are two twisted wires, each twisted wire can include different numbers of guide wires, and the different numbers of guide wires are twisted separately to form different twisted wires, and the different twisted wires are helically wound together to form Medical wire; or, when at least two strands are three strands or more, the two strands or each strand may also include different numbers of guide wires, and the different numbers of guide wires are twisted separately to form Different stranded wires are helically wound together to form medical wires.

That is, in the actual operation process, the number of guide wires in each stranded wire can be selected according to actual needs, and whether the number of guide wires in any two stranded wires is the same can also be selected according to actual needs.

In a preferred embodiment, the diameter of each guide wire is 0.05-0.2mm, and the diameter of the medical wire formed by the guide wire of this diameter is small, especially the number of guide wires in each twisted wire is 2- When there are 4 wires and the total number of guide wires is 8-16, the medical guide wires made of the above-mentioned diameter guide wires have better space utilization, flexibility and stretchability.

In a preferred embodiment, the medical wire includes an insulating layer, and the insulating layer is arranged around at least two twisted wires and covers the outside of the at least two twisted wires. Preferably, the insulating layer is, for example, a polymer insulating layer, and the insulating layer is more preferably a material with good biocompatibility.

As shown in Figures 1 and 2, in the first embodiment of the present application, the medical guide wire 100 includes 4 twisted wires, and the 4 twisted wires are helically wound, wherein each twisted wire is formed by twisting three guide wires respectively .

Specifically, the first strand of the 4 twisted wires includes 3 first guide wires 11, 12, 13, and the 3 first guide wires 11, 12, 13 are pre-twisted; The two stranded wires include 3 second guide wires 21, 22, 23, and the 3 second guide wires 21, 22, 23 are pre-twisted; the third stranded wire in the 4 stranded wires includes 3 third guide wires 31, 32, 33, 3 third guide wires 31, 32, 33 are pre-twisted; the fourth strand of 4 twisted wires includes 3 fourth guide wires 41, 42, 43, 3 fourth guide wires The wires 41, 42, 43 are pre-twisted.

Then the first stranded wire, the second stranded wire, the third stranded wire and the fourth stranded wire are spirally wound together to obtain the medical lead wire 100 .

In this embodiment, three guide wires are twisted to form a stranded wire, and then 4 stranded wires are helically wound to form the medical lead 100 , which has better flexibility and stretchability, and has a high space utilization rate. Among them, in addition, under the premise that the total number of guide wires in the medical guide wire is the same, the diameter of the medical guide wire 100 obtained by twisting 3 guide wires in advance and then spirally winding is the same as that of the medical guide wire 100 obtained by directly spirally winding 12 guide wires. 300 (as shown in Figure 4), there is no significant difference between the two. That is, multiple guide wires are twisted to form a stranded wire, and the diameter of the medical wire after helical winding will not increase, which helps to strictly control the diameter of the medical wire, and at the same time increases the flexibility and stretchability of the medical wire.

As shown in FIG. 4 and FIG. 5 , a medical lead 300 is provided in the second embodiment of the present application.

The medical guide wire 300 is made by spirally winding 12 guide wires 301 , 302 , 303 , 304 , 305 , 306 , 307 , 308 , 309 , 310 , 311 , 312 .

Since 12 guide wires are helically wound to form a single-layer coil, in the axial direction of the medical guide wire 300, the space utilization rate of the guide wire increases, but the pitch between the coils formed by each guide wire increases, resulting in the medical guide wire 300 There is a decrease in flexibility.

In addition, 12 guide wires are helically wound to form a single-layer coil, so the diameter of the medical guide wire 300 is approximately the same as that of the medical guide wire 100 .

In addition, compared with the medical leads shown in FIG. 4 and FIG. 5 , when the medical lead 100 formed by at least two twisted wires is connected to the connection device, the guide wire in the medical lead 100 is more convenient to connect with the medical lead 100 in the connection device. The channel connector realizes the connection, and the connection device is used for stimulating electrode connection. Specifically, with reference to Fig. 5, it can be seen at the end face of the medical lead wire 300 in Fig. 5 that the positions of the ends of the 12 guide wires are relatively scattered, so when connecting with the channel connectors in the connecting device, the wiring is more convenient. complex. On the other hand, at one end of the medical guide wire 100 shown in FIG. 2 , the positions of the ends of the 12 guide wires are more concentrated, which is more convenient for wiring when connecting with the channel connector in the connecting device. The channel connection part in the connection device is, for example, the channel connection part on the connector, and the channel connection part is, for example, a canted coil spring. The connection device is connected to a pulse generator or a stimulating electrode through a medical wire.

The present application also provides an implantable medical device, which transmits electrical stimulation through at least one of the above-mentioned medical leads 100 and 300 .

In a preferred embodiment, one end of each guiding wire of the medical wire is electrically connected to a stimulating electrode, and the opposite end of each guiding wire is electrically connected to a stimulator. The stimulator outputs electrical stimulation signals, the electrical stimulation signals are transmitted to the stimulating electrodes through the guide wire, and the stimulating electrodes output electrical stimulation to act on the target position. In a specific embodiment, the implantable medical device includes a stimulating electrode, a medical wire and a stimulator, one end of each guide wire in the wire structure is electrically connected to the stimulating electrode, and the opposite end of each guide wire is Electrically connect the stimulator. In another embodiment, one end of each guiding wire of the medical wire is electrically connected to the stimulating electrode, and the opposite end of each guiding wire is electrically connected to the connector, and the connector is connected to the stimulator through a conductive wire; or, each medical wire One end of a guide wire is electrically connected to the stimulator, and the opposite end of each guide wire is electrically connected to a connector, and the connector is connected to the stimulation electrode through a conductive wire. Wherein, the conductive wire may also be the medical wire in the above embodiment.

To sum up, this application proposes an implantable medical device and its medical wire. Multiple guide wires are twisted to form a stranded wire, and the multi-strand wires are helically wound to form a medical wire. On the one hand, when the number of guide wires increases, the The diameter does not change significantly, and can be strictly controlled to avoid damage caused by intrusive operations, and the space utilization rate is high; on the other hand, the pitch between the coils of each twisted wire in the medical wire is reduced, and the medical wire has better performance. Flexibility and stretchability reduce the foreign body sensation of implants.

Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be construed as limitations to the present invention. Under the circumstances, the above-mentioned embodiments can be changed, modified, replaced and modified within the scope of the invention, and all these changes should fall within the protection scope of the claims of the present invention.

Claims (10)

1. A medical lead suitable for implantable medical devices, wherein the medical lead includes:

   At least two twisted wires, the at least two twisted wires are helically wound together along the axial direction of the medical lead;

   Wherein, at least two guide wires are twisted to form a twisted wire.
2. The medical lead according to claim 1, wherein the at least two strands comprise a first strand and a second strand, at least a first number of guide wires are twisted to form the first strand, at least the second Two numbers of guide wires are twisted to form a second twisted wire; wherein, the first number and the second number are the same or different.
3. The medical lead according to claim 1, wherein the at least two twisted wires include four twisted wires, each twisted wire in the four twisted wires includes three guide wires, and the three guide wires are twisted to form a twisted wire .
4. The medical lead wire according to claim 1, wherein the number of said guide wires in each twisted wire is 2-4.
5. The medical guide wire according to claim 4, wherein the total number of the guide wires in the medical guide wire is 4-20.
6. The medical guide wire according to claim 1, wherein the diameter of each guide wire is 0.05-0.2mm.
7. The medical guide wire according to claim 6, wherein the number of the guide wires in each twisted wire is 2-4, and the total number of the guide wires in the medical guide wire is 8-16.
8. The medical lead according to claim 1, wherein the medical lead further comprises an insulating layer, the insulating layer is arranged around the at least two twisted wires, and the insulating layer covers the at least two twisted wires of the exterior.
9. An implantable medical device, wherein the implantable medical device transmits electrical stimulation through the medical wire according to any one of claims 1-8.
10. The implantable medical device according to claim 9, wherein the implantable medical device comprises a stimulating electrode, a medical wire and a stimulator, and one end of each guide wire in the wire structure is electrically connected to the stimulating electrode, so The opposite end of each guidewire described above is electrically connected to the stimulator; or,

    The implantable medical device includes stimulating electrodes, medical wires, connectors and stimulators, one end of each guide wire of the medical wires is electrically connected to the stimulating electrodes, and the opposite end of each guide wire is electrically connected to the a connector that connects the stimulator via conductive wires; or,

    The implantable medical device includes stimulating electrodes, medical wires, connectors and stimulators, one end of each guide wire of the medical wires is electrically connected to the stimulator, and the opposite end of each guide wire is electrically connected to the connector, so The above-mentioned connector connects the stimulating electrodes through conductive wires.

Images