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

Implantable nerve stimulator

Technical Field

The invention relates to the technical field of medical appliances, in particular to an implantable neurostimulator.

Background

With the development of interventional medical procedures and neuroscience techniques, implantable neurostimulation systems are widely used in clinic. The existing electrical stimulation system mainly comprises a pulse generator (Implantable Pulse Generator, IPG) implanted in a body, a stimulation electrode (Lead), an in-body Extension wire (Extension), an in-vitro program control device (program & Remoter), a related Surgical tool (Surgical tool) and the like.

In an electro-stimulation system, the pulse generator is implanted in the human body as a signal source of the overall system, such as the chest location. The circuit parts of the pulse generator, such as the signal generating module, are enclosed in a housing of the pulse generator, the circuit parts in the housing delivering electrical signals through feedthroughs into the connection cavities of the housing-external enclosure. The connecting cavity transmits signals to the electrode through connection with the internal extension lead, so that the target point is stimulated.

Along with the iteration of the technology, the electric stimulation is not only applied to the treatment of diseases such as Parkinson and the like, but also has unique tree construction in the fields such as pain, urinary and the like. However, the electrode design is applied to the human body parts with complex environments such as brain, and has the defect of difficult replacement, so how to design the electrode-free electric stimulation system is a technical problem which needs to be solved by the technicians in the field.

Disclosure of Invention

The invention aims to provide an implantable neurostimulator, wherein a stimulator shell comprises electrode contacts as generating components of electrical stimulation, electrodes are not required to be designed outside the stimulator shell, and therefore implantation of the electrodes is not required, so that the operation frequency is reduced, and the assembly risk is reduced.

In order to solve the above technical problems, 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 stimulation as an electrode contact and an insulating housing that serves 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 neurostimulator further includes a positioning hole disposed at one end of the stimulator housing for fixing the implantable neurostimulator in a patient.

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

Optionally, the material of the electrode housing comprises a metal and the material of the insulating housing comprises a ceramic.

Optionally, the metal comprises titanium or a titanium alloy; the ceramic comprises zirconia.

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

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

Optionally, the implantable neural stimulator further comprises an energy-absorbing jacket, wherein the implantable neural stimulator is fixedly implanted in a patient together with the energy-absorbing jacket, and the energy-absorbing jacket at least surrounds part of the stimulator housing.

Optionally, the material of the energy absorbing jacket comprises a polymeric material.

Optionally, when the target point position in the human tissue needs to be provided with a fusion device or an artificial joint, the energy-absorbing outer sleeve is the artificial joint or the fusion device, and the implantable neural stimulator is fixed on the fusion device or the artificial joint and is implanted into the patient together.

Optionally, the section of the stimulator shell along the second direction is semicircular and 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.

Optionally, the electrode housings and the insulating housing are alternately connected in the first direction, and in the second direction, the electrode housings located at both sides of the stimulator housing are isolated by the insulating housing 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 invention, the stimulator housing comprises an electrode housing and an insulating housing, wherein the electrode housing is used as an electrode contact to provide electrical stimulation, and the insulating housing is used for isolating the adjacent electrode housings. The stimulator housing comprises electrode contacts as generating components for electrical stimulation, and electrodes are not required to be arranged outside the stimulator housing, so that implantation of the electrodes is not required, the operation times are reduced, the assembly risk is reduced, and the infection risk caused by the implant can be reduced.

Furthermore, the electrode shells are alternately connected with the insulating shells in the first direction, and the electrode shells positioned at two sides of the stimulator shell are isolated by the insulating shells in the second direction to serve as two electrode contacts, so that the directional stimulation of the implantable neurostimulator is realized.

Furthermore, a charging coil and a circuit board connected with the charging coil are arranged in the stimulator shell, and for patients with non-long-term pain, the battery-free design can be adopted, and the charging coil is directly used for supplying power for electric stimulation, so that the size of the implantable nerve stimulator can be reduced, and the foreign body sensation during activities can be reduced.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention.

Fig. 1 is a schematic diagram illustrating an external structure of an implantable neural stimulator according to an embodiment of the present invention.

Fig. 2 is a schematic diagram illustrating an internal structure of an implantable neural stimulator according to an embodiment of the present invention.

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

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

Fig. 5 is a schematic diagram showing an external structure of an implantable neural stimulator with directional stimulation according to an embodiment of the present invention.

FIG. 6 is a schematic structural view of an energy absorbing outer jacket according to an embodiment of the present invention.

Fig. 7 is a schematic view of an implantable neurostimulator according to an embodiment of the present invention secured to a fusion device.

Reference numerals:

1-an electrode housing; 1 a-a first electrode housing; 1 b-a second electrode housing; 2-an insulating housing; 3-positioning holes; 4-a charging coil; 5-battery; 6-a circuit board; 7-circuit connection lines; 8-energy absorbing coat; 9-an assembly groove; 10-an implantable neurostimulator; 11-fusion device.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "a first", "a second", and "a third" may include one or at least two of the feature, either explicitly or implicitly, unless the context clearly dictates otherwise.

Fig. 1 is a schematic diagram illustrating an external structure of an implantable neural stimulator according to an embodiment of the present invention. Referring to fig. 1, the implantable neurostimulator 10 includes a stimulator housing and a stimulation circuit disposed in the stimulator housing, the stimulator housing includes an electrode housing 1 and an insulating housing 2, the electrode housing 1 is used as an electrode contact to provide electrical stimulation, and the insulating housing 2 is used to isolate adjacent electrode housings 1.

The electrode shell 1 is used as an electrode contact to provide electric stimulation, the stimulator shell comprises the electrode contact and is used as an electric stimulation generating component, and an electrode does not need to be arranged outside the stimulator shell, so that the electrode does not need to be implanted again, the operation frequency is reduced, the assembly risk is reduced, and the infection risk caused by an implant can also be reduced. Moreover, the implantable neurostimulator 10 without the independent electrodes is more convenient for some target positions with easy operation or low operation risk, has less total foreign matters and better patient experience.

The stimulation housing comprises the electrode housing 1 and the insulating housing 2 alternately connected to form a plurality of electrode contacts. Fig. 1 shows the electrode case 1 in 4 parts and the insulating case 2 in 4 parts, and the number of the electrode case 1 and the insulating case 2 is not limited thereto and may be determined according to actual requirements. The electrode housing 1 and the insulating housing 2 are both biocompatible materials, and the material of the electrode housing 1 illustratively comprises a metal comprising titanium, a titanium alloy, or other materials known to those skilled in the art. The material of the insulating housing 2 comprises a ceramic comprising 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. The stimulator housing may be divided into three parts, one end (e.g., the left end in fig. 1), the other end (e.g., the right end in fig. 1), and a middle part, wherein one end is the electrode housing 1, electrical stimulation may be provided, the other end is the insulating housing 2, which is used as a protection area for wireless charging (which will be described later), to avoid unnecessary damage caused by metal heating, and the middle part is where the insulating housing 2 is alternately connected with the electrode housing 1.

The implantable neurostimulator 10 further comprises a positioning hole 3, wherein the positioning hole 3 is disposed at one end of the stimulator housing, so that the implantable neurostimulator 10 is fixed in a patient, such as a chest, an abdomen or a brain of the patient. In particular, the implantable neurostimulator 10 may be fixed to the tissue in the patient by a suture thread through the positioning hole 3. In this embodiment, the positioning hole 3 is located at the end of the stimulator housing having the insulating housing 2.

Fig. 2 is a schematic diagram illustrating an internal structure of an implantable neural stimulator according to an embodiment of the present invention. Referring to fig. 1 and 2, a charging coil 4, a circuit board 6 connected with the charging coil 4, and a circuit connection wire 7 connecting the circuit board 6 with a feedthrough outside the stimulator housing are disposed in the stimulator housing; the charging coil 4 is located inside the stimulator housing at the end with the insulating housing 2. The insulating housing 2 is located at the periphery of the charging coil 4, so that heating caused by an eddy current effect does not exist in the charging process of the charging coil 4, and unnecessary damage to a patient caused by heating of the charging coil 4 can be avoided.

For patients with non-chronic pain, the design without a battery can be adopted, the charging coil 4 is directly powered for electric stimulation, and the charging coil 4 receives energy in real time in a wireless charging mode, so that the size of the implantable neural stimulator 10 can be reduced, and the foreign body sensation during activity can be reduced.

In patients with long-term pain or patients requiring frequent demands of the implantable neurostimulator 10, a battery 5 is further provided between the charging coil 4 and the circuit board 6 in the implantable neurostimulator 10 to store electric power for powering the circuit board 6, and the charging coil 4 receives energy by wireless charging and stores the energy in the battery 5.

In this embodiment, the stimulator housing may be semicircular, circular, semi-elliptical or oval in cross-section, and may be any shape known to those skilled in the art, which may vary depending on the location of implantation in the patient. Referring to fig. 1, a horizontal direction in the figure is set as a first direction x, and a vertical direction in the figure is set as a second direction y, wherein the first direction x is perpendicular to the second direction y. In fig. 1, the stimulator housing has an elliptical cross-section in a first direction x. Of course, the cross-section of the stimulator housing in the first direction x may be any shape suitable for implantation in a patient, such as a semi-oval, semi-circular, rectangular or square shape.

As shown in fig. 3, the cross-sectional view of the stimulator housing is circular, and fig. 3 is a cross-sectional view of fig. 1 in the second direction y, the cross-section of the stimulator housing in the second direction y is circular. Fig. 3 shows a cross-section at a location where the stimulator housing has an electrode housing 1. As shown in fig. 1 and 3, the cross section of the stimulator housing in the first direction x is elliptical, and the cross section in the second direction y is circular, so that the stimulator housing is in an ellipsoidal shape, or the stimulator housing is in a capsule shape, which is easy to be implanted into a patient and has a small foreign body sensation.

As shown in fig. 4, the cross-section of the stimulator housing is semicircular, and fig. 4 is also a cross-section of the stimulator housing in the second direction y, which is not shown, and the cross-section of the stimulator housing in the first direction x is semicircular. Fig. 4 shows a cross-section also at the location where the stimulator housing has an electrode housing 1. The cross section of the stimulator housing in the first direction x may be semi-elliptical, and the cross section in the second direction y may be semi-circular, so that the stimulator housing has a semi-ellipsoidal shape, which is also easy to be implanted into a patient, and has a small foreign body sensation. The above embodiments exemplify only two shapes of the stimulator housing, and the shape of the stimulator housing is not limited thereto.

Fig. 5 is a schematic diagram showing an external structure of an implantable neural stimulator with directional stimulation according to an embodiment of the present invention. Referring to fig. 5, the electrode housings 1 and the insulating housing 2 are alternately connected in the first direction x, and the electrode housings 1 on both sides of the stimulator housing are separated by the insulating housing 2 in the second direction y to form a first electrode housing 1a and a second electrode housing 1b as two electrode contacts, thereby realizing directional stimulation. In the present embodiment, only the electrode housing 1 located at the middle portion of the stimulator housing is isolated by the insulating housing 2, and the electrode housing 1 located at one end (left end in fig. 5) of the stimulator housing is not necessarily isolated, but is not limited thereto.

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

The implantable neurostimulator 10 may be fixed to an energy-absorbing jacket for implantation in a patient, and fig. 6 is a schematic structural diagram of an energy-absorbing jacket according to an embodiment of the present invention, and as shown in fig. 6, a cross section of the energy-absorbing jacket 8 is arc-shaped, in which an assembly groove 9 is formed, and a portion of the stimulator housing is assembled in the assembly groove 9, that is, the energy-absorbing jacket 8 surrounds a portion of the stimulator housing for long-term stress protection. That is, the energy absorbing shell 8 is able to cushion part of the pressure when the stimulator housing is pressed externally; the energy absorbing shell 8 is also able to cushion part of the impact forces when the stinger housing is slightly moved, so as to avoid impacting human tissue. The energy absorbing jacket 8 is typically made of a polymer material with good elasticity and fatigue, such as PEEK (Poly ether ether Ketone ), but is not limited thereto. The energy absorbing shell 8 may also be replaced with a custom made artificial joint or an intersyramid fusion cage to provide better fixation.

It should be noted that, the cross section of the energy-absorbing outer sleeve 8 shown in fig. 6 is arc-shaped and matches the shape of the implantable neural stimulator 10 shown in fig. 1, and when the shape of the implantable neural stimulator 10 changes, the shape of the energy-absorbing outer sleeve 8 will correspondingly change, that is, the shape of the energy-absorbing outer sleeve 8 matches the shape of the implantable neural stimulator 10.

For example, in general, patients with CSC (spinal cord electro-stimulation) are patients with failed joint removal surgery, where there may be a need for a fusion cage or artificial joint at the target site, and where the energy-absorbing shell 8 may be a fusion cage or artificial joint as needed by the patient, the implantable neurostimulator 10 is fixed on the fusion cage or artificial joint, and implanted together in the patient. Fig. 7 is a schematic view of an implantable neurostimulator according to an embodiment of the present invention secured to a fusion device. As shown in fig. 7, the implantable neurostimulator 10 is fixed to the fusion device 11, and the fusion device 11 is implanted into the patient together with the implantable neurostimulator 10. Since the fusion device 11 is required to be implanted at the target site in the patient, the implantable neurostimulator 10 and the fusion device 11 are fixed and implanted together, so that the operation frequency can be reduced, and the infection risk caused by the implant can be reduced.

In summary, in the implantable neurostimulator provided by the invention, the stimulator housing includes an electrode housing and an insulating housing, the electrode housing is used as an electrode contact to provide electrical stimulation, and the insulating housing is used for isolating adjacent electrode housings. The stimulator housing comprises a plurality of electrode contacts as generating components of electric stimulation, and electrodes are not required to be arranged outside the stimulator housing, so that implantation of the electrodes is not required, the operation times are reduced, the assembly risk is reduced, and the infection risk caused by an implant can be reduced.

Furthermore, the electrode shells are alternately connected with the insulating shells in the first direction, and the electrode shells positioned at two sides of the stimulator shell are isolated by the insulating shells in the second direction to serve as two electrode contacts, so that the directional stimulation of the implantable neurostimulator is realized.

Furthermore, a charging coil and a circuit board connected with the charging coil are arranged in the stimulator shell, and for patients with non-long-term pain, the battery-free design can be adopted, and the charging coil is directly used for supplying power for electric stimulation, so that the size of the implantable nerve stimulator can be reduced, and the foreign body sensation during activities can be reduced.

The foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the claims, and any person skilled in the art may make any possible variations and modifications to the technical solution of the present invention using the method and technical content disclosed above without departing from the spirit and scope of the invention, so any simple modification, equivalent variation and modification made to the above embodiments according to the technical matter of the present invention fall within the scope of the technical solution of the present invention.

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.