CN117695521A - Implantable nerve stimulator - Google Patents

Abstract

The present invention provides an implantable neurostimulator comprising: a stimulator housing and a stimulation circuit within the stimulator housing; the stimulator housing includes an electrode housing that provides electrical stimulation as an electrode contact and an insulating housing that serves to isolate adjacent electrode housings. The stimulator shell comprises the electrode contact as a generating component of electric stimulation, and an electrode does not need to be arranged outside the stimulator shell, so that the implantation of the electrode is not needed, the operation frequency is reduced, the assembly risk is reduced, and the infection risk caused by the implant is also reduced.

Description

an implantable neurostimulator

Technical field

The present invention relates to the technical field of medical devices, and in particular to an implantable nerve stimulator.

Background technique

With the development of interventional medical surgery and neuroelectronic science and technology, implantable neurostimulation systems are widely used in clinical applications. The existing electrical stimulation system mainly consists of an implanted pulse generator (Implantable PulseGenerator, IPG), stimulation electrode (Lead), internal extension wire (Extension), external programmable equipment (Programmer & Remoter), and related surgical tools (Surgical tool), etc. Partially composed.

In electrical stimulation systems, the pulse generator is implanted in the human body as the signal source of the overall system, such as in the chest. The circuit parts such as the signal generation module of the pulse generator are packaged in a shell of the pulse generator. The circuit part in the shell transmits the electrical signal to the connection cavity of the outer shell package through the feedthrough. The connection cavity transmits the signal to the electrode through the connection with the extension wire in the body, thereby stimulating the target point.

With the iteration of technology, electrical stimulation is not only used to treat diseases such as Parkinson's, but also has unique achievements in fields such as pain and urology. The design of electrodes for use in parts of the human body with complex environments such as the brain has the disadvantage that they are difficult to replace. Therefore, how to design an electrodeless electrical stimulation system is a technical problem that technicians in the field urgently need to solve.

Contents of the invention

The object of the present invention is to provide an implantable nerve stimulator, the stimulator shell of which contains electrode contacts as the generating component of electrical stimulation. There is no need to design electrodes outside the stimulator shell, so there is no need to implant the electrodes. This reduces the number of surgeries and assembly risks.

In order to solve the above technical problems, the present invention provides an implantable nerve stimulator, which includes: a stimulator shell and a stimulation circuit located in the stimulator shell; the stimulator shell includes an electrode shell and an insulating shell, and the electrode shell As electrode contacts provide stimulation, the insulating housing is used to isolate adjacent electrode housings.

Optionally, one end of the stimulator housing is the electrode housing, and the other end is the insulating housing.

Optionally, the implantable nerve stimulator further includes a positioning hole provided at one end of the stimulator housing for fixing the implantable stimulator in the patient's body.

Optionally, the positioning hole is located at one end of the stimulator housing having the insulating housing.

Optionally, the electrode shell is made of metal, and the insulation shell is made of ceramic.

Optionally, the metal includes titanium or titanium alloy; the ceramic includes zirconia.

Optionally, a charging coil and a circuit board connected to the charging coil are provided in the stimulator housing; the charging coil is located inside one end of the stimulator housing having the insulating housing.

Optionally, a battery is also provided in the stimulator housing, and the battery is located between the charging coil and the circuit board.

Optionally, an energy-absorbing jacket is also included. The implantable nerve stimulator is fixed with the energy-absorbing jacket and implanted into the patient's body. The energy-absorbing jacket surrounds at least part of the stimulator shell.

Optionally, the energy-absorbing jacket is made of a polymer material.

Optionally, when a fusion device or an artificial joint needs to be installed at the target location in human tissue, the energy-absorbing jacket is an artificial joint or a fusion device, and the implantable nerve stimulator is fixed to the fusion device or the artificial joint. It is implanted into the patient's body together with the joint.

Optionally, the cross-section of the stimulator housing along the second direction is semicircular or circular; the cross-section of the stimulator housing along the first direction is semi-elliptical or elliptical; wherein the first direction and the The second direction is perpendicular.

Optionally, the electrode housings and the insulating housing are alternately connected in the first direction, and in the second direction, the electrode housings located on both sides of the stimulator housing are connected to each other through the insulating housing. Isolated to serve as two electrode contacts.

Optionally, in the second direction, the electrode housing is located on the same side of the stimulator housing.

In the implantable neurostimulator provided by the present invention, the stimulator housing includes an electrode housing and an insulating housing. The electrode housing serves as an electrode contact to provide electrical stimulation, and the insulating housing is used to isolate adjacent electrode housings. The stimulator shell contains electrode contacts as electrical stimulation generating components, and there is no need to set electrodes outside the stimulator shell. Therefore, there is no need to implant electrodes, thereby reducing the number of surgeries and assembly risks, and also The risk of infection from implants can be reduced.

Further, the electrode housings and the insulating housings are alternately connected in the first direction, and in the second direction, the electrode housings located on both sides of the stimulator housing are isolated by the insulating housings to serve as two electrode contacts. , thereby achieving directional stimulation of the implanted neurostimulator.

Furthermore, the stimulator housing is provided with a charging coil and a circuit board connected to the charging coil. For patients with non-long-term pain, a battery-less design can be adopted, and the charging coil is directly used for power supply for electrical stimulation, so that the patient can Reduce the size of the implanted neurostimulator to reduce the foreign body sensation during activity.

Description of the drawings

It should be understood by those of ordinary skill in the art that the drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

Figure 1 is a schematic diagram of the external structure of an implantable nerve stimulator provided by an embodiment of the present invention.

Figure 2 is a schematic diagram of the internal structure of an implantable neurostimulator provided by an embodiment of the present invention.

Figure 3 is a cross-sectional view of a stimulator housing provided by an embodiment of the present invention.

Figure 4 is a cross-sectional view of a stimulator housing provided by another embodiment of the present invention.

Figure 5 is a schematic diagram of the external structure of an implantable nerve stimulator with directional stimulation provided by an embodiment of the present invention.

Figure 6 is a schematic structural diagram of an energy-absorbing jacket provided by an embodiment of the present invention.

Figure 7 is a schematic diagram of fixing an implantable neurostimulator to a cage according to an embodiment of the present invention.

Reference signs:

1-electrode shell; 1a-first electrode shell; 1b-second electrode shell; 2-insulating shell; 3-positioning hole; 4-charging coil; 5-battery; 6-circuit board; 7-circuit connecting wire; 8 -Energy-absorbing jacket; 9-assembly slot; 10-implantable neurostimulator; 11-fusion device.

Detailed ways

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions.

As used in this invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in its sense including "and/or", and the term "several" The term "at least two" is usually used in a meaning including "at least one", and the term "at least two" is usually used in a meaning including "two or more". In addition, the terms "first" and "th "Second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying the relative importance or implicitly indicating the quantity of the technical features indicated. Thus, features defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of these features, unless the content clearly indicates otherwise.

Figure 1 is a schematic diagram of the external structure of an implantable nerve stimulator provided by an embodiment of the present invention. Please refer to Figure 1. The implantable neurostimulator 10 includes a stimulator shell and a stimulation circuit located in the stimulator shell. The stimulator shell includes an electrode shell 1 and an insulating shell 2. The electrode shell 1 serves as an electrode contact to provide electrical stimulation, and the insulating shell 2 is used to isolate the adjacent electrode shell 1.

The electrode housing 1 serves as an electrode contact to provide electrical stimulation. The stimulator housing contains the electrode contact as a generating component for electrical stimulation. There is no need to set electrodes outside the stimulator housing, so there is no need to perform The re-implantation of electrodes reduces the number of surgeries, reduces the risk of assembly, and also reduces the risk of infection caused by the implant. Moreover, the use of the implantable neurostimulator 10 without independent electrodes makes it more convenient for some target locations that are easy to operate or have low surgical risks, with less foreign matter overall, and a better patient experience.

The stimulation housing includes the electrode housing 1 and the insulating housing 2 that are alternately connected to form multiple electrode contacts. Figure 1 shows four parts of the electrode housing 1 and four parts of the insulation housing 2. The number of the electrode housing 1 and the insulation housing 2 is not limited to this and can be determined according to actual needs. Both the electrode housing 1 and the insulating housing 2 are made of biocompatible materials. For example, the material of the electrode housing 1 includes metal, and the metal includes titanium, titanium alloy, or those skilled in the art. other known materials. The material of the insulating shell 2 includes ceramic, and the ceramic includes zirconia, or other materials known to those skilled in the art. The metal and the ceramic may be connected by welding.

In this embodiment, one end of the stimulator housing is the electrode housing 1, and the other end is the insulating housing 2. That is, the stimulator shell can be divided into three parts, one end (such as the left end in Figure 1), the other end (such as the right end in Figure 1) and the middle part. One end is the electrode shell 1, which can provide electrical stimulation, and the other end The insulating shell 2 serves as a protective area for wireless charging (will be described later) to avoid unnecessary damage caused by metal heating, and the middle part is where the insulating shell 2 and the electrode shell 1 are alternately connected.

The implantable nerve stimulator 10 also includes a positioning hole 3, which is provided at one end of the stimulator housing, so that the implantable nerve stimulator 10 can be fixed in the patient's body, such as the patient's chest, abdomen or brain. Specifically, the implantable nerve stimulator 10 can be fixed to the tissue in the patient's body through sutures through the positioning hole 3 . In this embodiment, the positioning hole 3 is located at one end of the stimulator housing with the insulating housing 2 .

Figure 2 is a schematic diagram of the internal structure of an implantable neurostimulator provided by an embodiment of the present invention. Please refer to Figures 1 and 2. A charging coil 4 is provided in the stimulator housing, a circuit board 6 connected to the charging coil 4, and a circuit board 6 connected to the circuit board 6 outside the stimulator housing. Feedthrough connected circuit connection wire 7; the charging coil 4 is located inside the end of the stimulator housing having the insulating housing 2. The insulating shell 2 is located on the periphery of the charging coil 4. During the charging process of the charging coil 4, there is no heat generated due to the eddy current effect, which can avoid unnecessary harm to the patient caused by the heating of the charging coil 4.

For patients with non-long-term pain, a battery-less design can be adopted, and the charging coil 4 is directly used for power supply for electrical stimulation, and the charging coil 4 receives energy in real time through wireless charging, thereby reducing the size of the implantable neurostimulator 10 volume to reduce the foreign body sensation during activities.

For patients with long-term pain, or patients with frequent needs for the implantable neurostimulator 10, in the implantable neurostimulator 10, between the charging coil 4 and the circuit board 6 A battery 5 is also required to store power to power the circuit board 6. The charging coil 4 receives energy through wireless charging and stores the energy in the battery 5.

In this embodiment, the cross-section of the stimulator shell can be semicircular, circular, semi-elliptical or elliptical, or can be any shape known to those skilled in the art, and its shape can be based on the shape of the stimulator implanted in the patient's body. changes depending on the location. Please refer to Figure 1. The horizontal direction in the figure is set as the first direction x, and the vertical direction in the figure is set as the second direction y. The first direction x is perpendicular to the second direction y. . In Figure 1, the cross section of the stimulator housing in the first direction x is oval. Of course, the cross section of the stimulator housing in the first direction x can also be a semi-elliptical, semi-circular, circular, rectangular or square shape, or any other shape suitable for implantation in the patient's body.

As shown in Figure 3, the cross-sectional view of the stimulator housing is circular. Figure 3 is a cross-sectional view of Figure 1 in the second direction y. The cross-section of the stimulator housing in the second direction y Round shape. Figure 3 shows a cross-sectional view of the stimulator housing at the point where the electrode housing 1 is present. As shown in FIG. 1 and FIG. 3 , the cross section of the stimulator housing in the first direction x is an ellipse, and the cross section in the second direction y is circular, so that the shape of the stimulator housing is It is in the form of an ellipsoid, or the shape of the stimulator shell is a capsule shape, which is easy to implant into the patient's body and has a relatively small foreign body sensation.

As shown in Figure 4, the cross-sectional view of the stimulator housing is semicircular. Figure 4 is also a cross-sectional view of the stimulator housing in the second direction y. The stimulator housing is in the first direction x. Not shown in the cross-sectional view above, the cross-section of the stimulator housing in the second direction y is semicircular. Figure 4 also shows a cross-section at the point where the stimulator housing has the electrode housing 1 . The cross-section of the stimulator housing in the first direction x may be a semi-ellipse, and the cross-section in the second direction y may be a semi-circle, so that the shape of the stimulator housing is a semi-ellipsoid. The shape is also easy to implant into the patient's body, and the foreign body sensation is relatively small. The above embodiment only lists two shapes of the stimulator housing, and the shape of the stimulator housing is not limited thereto.

Figure 5 is a schematic diagram of the external structure of an implantable nerve stimulator with directional stimulation provided by an embodiment of the present invention. Please refer to Figure 5. The electrode housing 1 and the insulating housing 2 are alternately connected in the first direction x. In the second direction y, the electrode housings 1 located on both sides of the stimulator housing are Isolated by the insulating shell 2, a first electrode shell 1a and a second electrode shell 1b are formed to serve as two electrode contacts, thereby achieving directional stimulation. In this embodiment, only the electrode housing 1 located in the middle part of the stimulator housing is isolated by the insulating housing 2, while the electrode housing 1 located at one end of the stimulator housing (the left end in Figure 5) There is no need to be quarantined, but it is not limited to this.

In the second direction y, the electrode housing 1 can be located on the same side of the stimulator housing, that is, the electrode housing 1 can also be arranged on one side, so that electrical signals can be released in a targeted manner.

The implantable nerve stimulator 10 can be fixed and implanted into the patient's body together with the energy-absorbing jacket. Figure 6 is a schematic structural diagram of the energy-absorbing jacket provided by one embodiment of the present invention. As shown in Figure 6, the energy-absorbing jacket 8 has an arc-shaped cross section, and an assembly groove 9 is formed in it. Part of the stimulator shell is assembled in the assembly groove 9, that is, the energy-absorbing jacket 8 surrounds part of the stimulator shell, which is used for long-term stress. Protect. That is, when the stimulator shell is squeezed externally, the energy-absorbing jacket 8 can buffer part of the pressure; when the stimulator shell moves slightly, the energy-absorbing jacket 8 can also buffer part of the collision force to avoid collisions. human tissue. The energy-absorbing jacket 8 is usually made of polymer materials with good elasticity and good fatigue resistance, such as PEEK (Poly ether ether Ketone), but is not limited thereto. The energy-absorbing jacket 8 can also be replaced with a customized artificial joint or intercone fusion device for better fixation.

It should be noted that the arc-shaped cross-section of the energy-absorbing jacket 8 shown in Figure 6 matches the shape of the implantable nerve stimulator 10 shown in Figure 1. When the implanted nerve stimulator 10 When the shape changes, the shape of the energy-absorbing jacket 8 will change accordingly, that is, the energy-absorbing jacket 8 matches the shape of the implantable nerve stimulator 10 .

For example, usually CSC (spinal cord electrical stimulation) patients are those who have failed joint removal surgery. There may be a need for a cage or artificial joint at the target location. In this case, the energy-absorbing jacket 8 can be what the patient needs. The implantable nerve stimulator 10 is fixed on the fusion device or artificial joint and implanted together into the patient's body. Figure 7 is a schematic diagram of fixing an implantable neurostimulator to a cage according to an embodiment of the present invention. As shown in FIG. 7 , the implantable nerve stimulator 10 is fixed on the cage 11 , and then the cage 11 and the implantable nerve stimulator 10 are implanted into the patient's body. Since the target point in the patient's body needs to be implanted with the fusion device 11, fixing the implantable neurostimulator 10 and the fusion device 11 and implanting them together can reduce the number of surgeries and reduce the cost of the implant. risk of infection.

To sum up, in the implantable nerve stimulator provided by the present invention, the stimulator housing includes an electrode housing and an insulating housing. The electrode housing serves as an electrode contact to provide electrical stimulation. The insulating housing is used to isolate all adjacent nerve stimulators. The electrode shell. The stimulator housing contains multiple electrode contacts, which serve as the generating components for electrical stimulation. There is no need to set electrodes outside the stimulator housing. Therefore, there is no need to implant electrodes, thereby reducing the number of surgeries and assembly risks. , can also reduce the risk of infection from implants.

Further, the electrode housings and the insulating housings are alternately connected in the first direction, and in the second direction, the electrode housings located on both sides of the stimulator housing are isolated by the insulating housings to serve as two electrode contacts. , thereby achieving directional stimulation of the implanted neurostimulator.

Furthermore, the stimulator housing is provided with a charging coil and a circuit board connected to the charging coil. For patients with non-long-term pain, a battery-less design can be adopted, and the charging coil is directly used for power supply for electrical stimulation, so that the patient can Reduce the size of the implanted neurostimulator to reduce the foreign body sensation during activity.

The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of rights of the present invention. Any person skilled in the art can use the methods and technical contents disclosed above to improve the present invention without departing from the spirit and scope of the present invention. Possible changes and modifications are made to the technical solution. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention, all belong to the technical solution of the present invention. protected range.

Claims (14)

1. An implantable neurostimulator, comprising: a stimulator housing and a stimulation circuit within the stimulator housing; the stimulator housing includes an electrode housing that provides electrical stimulation as an electrode contact and an insulating housing that is used to isolate adjacent electrode housings.

2. The implantable neurostimulator of claim 1, wherein one end of the stimulator housing is the electrode housing and the other end is the insulating housing.

3. The implantable neurostimulator of claim 2, further comprising a positioning hole disposed at one end of the stimulator housing for securing the implantable stimulator within a patient.

4. The implantable neurostimulator of claim 3 wherein the locating hole is located at an end of the stimulator housing having the insulating housing.

5. The implantable neurostimulator of claim 1, wherein the material of the electrode housing comprises metal and the material of the insulating housing comprises ceramic.

6. The implantable neurostimulator of claim 5, wherein said metal comprises titanium or a titanium alloy; the ceramic comprises zirconia.

7. The implantable neurostimulator of claim 2, wherein a charging coil and a circuit board connected to the charging coil are disposed within the stimulator housing; the charging coil is located inside the stimulator housing having one end of the insulating housing.

8. The implantable neurostimulator of claim 7, wherein a battery is also disposed within the stimulator housing, the battery being located between the charging coil and the circuit board.

9. The implantable neurostimulator of claim 1 further comprising an energy absorbing sheath, wherein in use the implantable neurostimulator is implanted in a patient with the energy absorbing sheath secured thereto, the energy absorbing sheath surrounding at least a portion of the stimulator housing.

10. The implantable neurostimulator of claim 9 wherein the energy absorbing sheath material comprises a polymeric material.

11. The implantable neurostimulator of claim 9, wherein the energy absorbing outer sleeve is an artificial joint or a fusion device when the target site in the human tissue requires placement of the fusion device or the artificial joint, and the implantable neurostimulator is fixed to the fusion device or the artificial joint and implanted together in the patient.

12. The implantable neurostimulator of claim 1, wherein the cross-section of the stimulator housing along the second direction is semicircular, circular; the section of the stimulator shell along the first direction is semi-elliptic or elliptic; wherein the first direction is perpendicular to the second direction.

13. The implantable neurostimulator of claim 12 wherein the electrode housings are alternately connected to the insulating housing in the first direction and the electrode housings on either side of the stimulator housing are separated by the insulating housing in the second direction as two electrode contacts.

14. The implantable neurostimulator of claim 13, wherein in the second direction, the electrode housing is on the same side of the stimulator housing.