CN115531723B - Spinal cord stimulation system - Google Patents

Abstract

The present disclosure relates to a spinal cord stimulation system. The spinal cord stimulation system includes: an electrode lead, which is suitable for being implanted in a patient's body and includes a plurality of electrode contacts; and a control device, which is suitable for being placed outside the patient's body and is configured to generate electric pulses and transmit the electric pulses to the electrode lead wirelessly, so that the plurality of electrode contacts of the electrode lead deliver the electric pulses to the patient's spinal nerves. According to the spinal cord stimulation system provided by the present disclosure, the control device is placed outside the patient's body and transmits the electric pulses to the electrode lead implanted in the patient's body wirelessly. If the spinal cord stimulation system provided by the present disclosure is adopted, it is only necessary to implant the electrode lead with a smaller volume into the patient's body without implanting the control device with a larger volume into the patient's body. Therefore, the use of the spinal cord stimulation system provided by the present disclosure can reduce the trauma to the patient during the implantation process.

Description

Spinal cord stimulation system

Technical Field

The present disclosure relates to the technical field of medical devices, and in particular to a spinal cord stimulation system.

Background Art

With the continuous advancement of medical technology, the use of implantable neurostimulation systems for treatment has become more and more common. As an implantable neurostimulation system, the spinal cord stimulation (SCS) system is used as a means of relieving pain for patients.

A conventional spinal cord stimulation system includes a control device (e.g., including a pulse generator and a battery, etc.) and an electrode lead implanted in the patient's body. During operation, multiple electrode contacts of the electrode lead deliver electrical pulses generated by the control device to the patient's spinal cord tissue to relieve the patient's pain.

However, since the control device has a large volume, a large incision must be made on the patient's body to implant the control device into the patient's body. As can be seen, the use of a traditional spinal cord stimulation system can cause great trauma to the patient.

Summary of the invention

In view of this, the present disclosure provides a spinal cord stimulation system. One object of the present disclosure is to reduce the trauma caused by the implantation process to the patient.

The present disclosure provides a spinal cord stimulation system including an electrode lead and a control device. The electrode lead is suitable for implantation in a patient's body and includes a plurality of electrode contacts. The control device is suitable for being placed outside the patient's body and is configured to generate electrical pulses and transmit the electrical pulses to the electrode lead wirelessly, so that the plurality of electrode contacts of the electrode lead deliver the electrical pulses to the patient's spinal nerves.

According to the spinal cord stimulation system provided by the present disclosure, the control device is placed outside the patient's body and transmits electrical pulses to the electrode leads implanted in the patient's body in a wireless manner. If the spinal cord stimulation system provided by the present disclosure is used, only the smaller electrode leads need to be implanted into the patient's body without implanting the larger control device into the patient's body. Therefore, the use of the spinal cord stimulation system provided by the present disclosure can reduce the trauma to the patient during the implantation process.

In one possible implementation, the spinal cord stimulation system provided by the present disclosure may further include a feedback sensor. The feedback sensor is configured to sense the evoked potential generated by the spinal nerve under the stimulation of the electrical pulse. The control device is electrically coupled to the feedback sensor and is configured to adjust the electrical pulse according to the evoked potential.

Some reasons, such as changes in the patient's body position, can cause the electrode contacts to shift relative to the corresponding spinal nerve target, which can lead to overstimulation or understimulation. Understimulation can lead to poor treatment results, meaning that the patient's pain cannot be effectively relieved. Overstimulation can have a negative impact on the patient's health and lead to spinal nerve damage.

According to the spinal cord stimulation system provided by the present disclosure, the control device can adaptively adjust the output electric pulse according to the evoked potential generated by the spinal nerve under the stimulation of the electric pulse sensed by the feedback sensor, so that the spinal cord stimulation system can always apply appropriate stimulation to the spinal nerve. Therefore, this implementation method can effectively avoid the over-stimulation or under-stimulation of the spinal nerve of the patient by the spinal cord stimulation system, thereby having a better treatment effect and having less negative impact on the health of the patient.

In a possible implementation, the control device is configured to adjust the electric pulse in response to the amplitude of the evoked potential sensed by the feedback sensor being lower than a first threshold value, so as to increase the amplitude of the evoked potential. By comparing whether the amplitude of the sensed evoked potential is lower than the first threshold value, it is possible to accurately determine whether there is under-stimulation, so that the electric pulse can be adjusted accordingly to increase the stimulation of the target point, increase the amplitude of the evoked potential, and improve the treatment effect.

In a possible implementation, the control device is configured to increase the amplitude of the electric pulse in response to the amplitude of the evoked potential being lower than the first threshold value, so as to increase the amplitude of the evoked potential. It has been proven that increasing the amplitude of the electric pulse can effectively increase the amplitude of the evoked potential, thereby improving the problem of under-stimulation and improving the treatment effect.

In a possible implementation, the control device is configured to adjust the electric pulse in response to the amplitude of the evoked potential being higher than the second threshold value to reduce the amplitude of the evoked potential. By comparing whether the amplitude of the sensed evoked potential is higher than the second threshold value, it is possible to accurately determine whether there is overstimulation, so that the electric pulse can be adjusted accordingly to reduce the stimulation to the target point, reduce the amplitude of the evoked potential, and improve the treatment effect.

In one possible implementation, the control device is configured to reduce the amplitude of the electric pulse in response to the amplitude of the evoked potential being higher than the second threshold value, so as to reduce the amplitude of the evoked potential. It has been proven that reducing the amplitude of the electric pulse can effectively reduce the amplitude of the evoked potential, thereby improving the problem of overstimulation and improving the treatment effect.

In a possible implementation, the spinal cord stimulation system provided by the present disclosure may further include a patch, which is suitable for adhering to the patient's skin, and the feedback sensor and the control device are attached to the patch. When in use, the patch can be adhered to the skin so that the control device and the feedback sensor can be reliably positioned in the appropriate position; when use is finished, the patch can be removed from the skin. This implementation has the advantages of easy operation and reliable positioning.

In one possible implementation, the patch includes an adhesive layer, in which conductive particles defining at least one conductive path are disposed. The patch is adapted to be adhered to the patient's skin through the adhesive layer. The feedback sensor is embedded in the adhesive layer to be electrically coupled to the control device through the at least one conductive path.

According to the spinal cord stimulation system provided by the present disclosure, the adhesive layer is used to position the patch (and the control device and the feedback sensor) on the patient's body, and to realize the electrical connection between the feedback sensor and the control device, so that there is no need to use additional lines to connect the feedback sensor and the control device. Therefore, this implementation method is conducive to simplifying the structure of the spinal cord stimulation system and reducing the complexity of the spinal cord stimulation system.

In a possible implementation, the control device includes a first electrical connector, and the patch also includes a second electrical connector adapted to the first electrical connector, and the second electrical connector is electrically coupled to the feedback sensor through at least one conductive path.

On the one hand, according to the above implementation, since the control device and the patch are connected by the first electrical connector and the second electrical connector, when no treatment is performed, only the control device can be removed and the patch can be retained on the patient's body. In this way, the number of times the patch is repeatedly pasted can be reduced. As the number of pastings increases, the adhesion ability of the patch inevitably decreases. After the patch can no longer be reliably fixed on the patient's body surface, the patch needs to be replaced. Therefore, this implementation can extend the service life of the patch and reduce the patient's treatment cost.

On the other hand, according to the above implementation, since the control device and the patch are two independent entities connected by a pair of electrical connectors, when the adhesion ability of the patch decreases, only the patch can be replaced without replacing the control device. Considering that the cost of the control device is higher than that of the patch, this implementation can further reduce the treatment cost of the patient.

In a possible implementation, the patch further includes a covering layer superimposed on the adhesive layer, and the second electrical connector is attached to the covering layer. When in use, the covering layer is located on the side of the adhesive layer away from the patient's skin. The covering layer can prevent the adhesive layer from adhering to the patient's clothing and protect the adhesive layer. In addition, since the second electrical connector is attached to the covering layer, after the adhesive ability of the adhesive layer decreases, only the adhesive layer can be replaced without replacing the covering layer and the second electrical connector. It can be seen that this implementation can further reduce the patient's treatment cost.

In a possible implementation, the first electrical connector and the second electrical connector respectively include a first magnetic attraction portion and a second magnetic attraction portion that match each other, and the first magnetic attraction portion and the second magnetic attraction portion cooperate to provide a magnetic attraction force to maintain the connection between the first electrical connector and the second electrical connector.

According to the spinal cord stimulation system provided by the present disclosure, the control device can be firmly attached to the patch through the first magnetic attraction portion and the second magnetic attraction portion, and the first electrical connector and the second electrical connector can remain reliably connected. Therefore, this implementation method has better reliability. In addition, compared with other methods (for example, fixing the control device to the patch with a fastener), this magnetic attraction method is easy to operate, especially considering that the patch is usually located on the patient's back.

In a possible implementation, the first electrical connector and the second electrical connector respectively include a first foolproof portion and a second foolproof portion that match each other. The first foolproof portion and the second foolproof portion can effectively prevent the first electrical connector and the second electrical connector from being incorrectly connected. Therefore, this implementation can improve the safety of the spinal cord stimulation system.

In one possible implementation, the control device transmits electric pulses to the electrode lead by electric field coupling. Electric field coupling, also known as capacitive coupling, is a coupling method caused by the existence of distributed capacitance. Electric field coupling wireless power transmission is a technology that realizes wireless energy transmission through coupling capacitance between metal plates.

Compared with the electromagnetic coupling method, if the electric field coupling method is used to transmit electric pulses, the receiving module of the electrode lead for receiving electric pulses can be made relatively small, which is conducive to reducing the size of the electrode lead, thereby reducing the trauma to the patient during the implantation process. In addition, the use of electric field coupling to transmit electric pulses has the advantage of low alignment requirements. Considering that it is difficult for patients to accurately judge the position of the receiving module of the electrode lead implanted in the body, if a method with higher alignment requirements is adopted, it will be more difficult for the patient to align and the user experience will be poor. In addition, the electric field coupling method also has the advantage of not being easy to generate eddy currents, which makes the receiving module of the electrode lead less likely to heat up, and thus has less negative impact on the patient.

In one possible implementation, the control device transmits electric pulses to the electrode leads by ultrasonic coupling. The transmitting module of the control device can convert the electric pulses into ultrasonic waves for output, and the receiving module of the electrode leads can restore the received ultrasonic waves into electric pulses, thereby realizing the transmission of electric pulses by ultrasonic coupling. On the one hand, since ultrasonic waves have better penetrating ability, the transmission of electric pulses by ultrasonic coupling has better transmission stability. On the other hand, compared with magnetic fields or electric fields, ultrasonic waves have less negative impact on the health of patients. On the other hand, ultrasonic waves will not or less affect the evoked potentials and/or the sensing of evoked potentials, so it is beneficial for the feedback sensor to more accurately sense the evoked potentials of the spinal nerves, thereby facilitating more precise regulation of the electric pulses.

In one possible implementation, the spinal cord stimulation system further includes an external programmer, which is configured to allow an operator to input control instructions and send the control instructions to the control device to program and/or query the control device.

Through the external programmer, the doctor and/or the patient can program and/or inquire about the control device. For example, after implantation, the doctor can program the control device through the external programmer to set the patient's treatment strategy. The treatment strategy may include the amplitude and/or frequency of the electric pulse set by the doctor according to the patient's condition, and may also include which electrode contacts among the multiple electrode contacts are used to output the electric pulse. In future follow-up, the doctor can inquire about the control device through the external programmer to view the patient's current treatment strategy, and can program the control device to adjust the treatment strategy according to changes in the patient's condition. For example, the patient can inquire about the control device through the external programmer to view the status of the control device (for example, the remaining power), or the patient can program the control device through the external programmer under the doctor's authority control to appropriately adjust the electric pulse.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for use in the embodiments are briefly introduced below.

It should be understood that the following drawings only depict certain embodiments of the present disclosure and therefore should not be considered limiting in scope.

It should be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements (members or components).

It should be understood that the drawings are merely schematic and that the sizes and proportions of elements (components or components) in the drawings are not necessarily accurate.

FIG. 1 is a schematic diagram showing a spinal cord stimulation system according to an embodiment of the present disclosure.

FIG. 2 is a schematic diagram showing the structure of a patch of the spinal cord stimulation system in FIG. 1 .

FIG. 3 is a schematic diagram showing the structure of the patch in FIG. 2 observed from another viewing angle.

FIG. 4 is a schematic partial cross-sectional view of the patch in FIG. 2 .

FIG. 5 is a schematic diagram of the structure of a control device of the spinal cord stimulation system in FIG. 1 .

FIG. 6 is a schematic structural diagram of the control device in FIG. 5 observed from another viewing angle.

FIG. 7 is a schematic diagram showing the structure of at least some modules of the control device in FIG. 5 .

FIG. 8 is a schematic diagram showing the structure of at least part of the modules of the coupling portion of the electrode leads of the spinal cord stimulation system in FIG. 1 .

9 is a schematic partial cross-sectional view of an electrode lead of the spinal cord stimulation system of FIG. 1 .

FIG. 10 is a schematic partial cross-sectional view of an electrode lead according to another embodiment of the present disclosure.

DETAILED DESCRIPTION

The following will be combined with the drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the described embodiments are only part of the embodiments of the present disclosure, not all of the embodiments.

Fig. 1 is a schematic diagram showing a spinal cord stimulation system 100 according to an embodiment of the present disclosure. It should be noted that, in Fig. 1 , reference numeral SC is used to indicate the spinal cord of a patient, and reference numeral SK is used to indicate the skin of a patient.

1 , a spinal cord stimulation system 100 includes a control device 10 and an electrode lead 20. The control device 10 is configured to be placed outside the patient's body. The electrode lead 20 is configured to be implanted into the patient's body. In particular, at least a portion of the electrode lead 20 can be implanted into the patient's spinal epidural space.

The electrode lead 20 includes a plurality of electrode contacts 21. Exemplarily, the number of the electrode contacts 21 may be 2, 4, 6, or 8. Of course, in other examples, the number of the electrode contacts 21 may also be other numbers, and the present disclosure does not specifically limit the number of the electrode contacts 21. For example, in some embodiments, the number of the electrode contacts 21 may also be an odd number.

The control device 10 is configured to generate an electrical pulse. It should be noted that in the present disclosure, an electrical pulse may refer to a current pulse or a voltage pulse. The control device 10 is also configured to transmit the electrical pulse to the electrode lead 20 in a wireless manner, so that the plurality of electrode contacts 21 of the electrode lead 20 deliver the electrical pulse to the patient's spinal nerves.

According to the spinal cord stimulation system 100 provided by the present disclosure, the control device 10 is placed outside the patient's body and transmits electrical pulses to the electrode lead 20 implanted in the patient's body in a wireless manner. If the spinal cord stimulation system 100 provided by the present disclosure is used, only the electrode lead 20 with a smaller volume needs to be implanted into the patient's body without implanting the control device 10 with a larger volume into the patient's body. Therefore, the use of the spinal cord stimulation system 100 provided by the present disclosure can reduce the trauma to the patient during the implantation process.

1, the spinal cord stimulation system 100 may further include a feedback sensor 30. The feedback sensor 30 is configured to sense the evoked potential generated by the spinal nerve under the stimulation of the electrical pulses delivered by the plurality of electrode contacts 21. The control device 10 is electrically coupled to the feedback sensor 30 to acquire the sensed evoked potential, and the control device 10 is configured to adjust the electrical pulse according to the sensed evoked potential.

Some reasons, such as changes in the patient's body position, may cause the electrode contact 21 to be relatively displaced from the corresponding target point of the spinal nerve, which may lead to overstimulation or understimulation. Understimulation may lead to poor treatment effect, that is, the patient's pain cannot be effectively relieved. Overstimulation may have a negative impact on the patient's health and cause spinal nerve damage.

According to the spinal cord stimulation system 100 provided by the present disclosure, the control device 10 can adaptively adjust the output electric pulse according to the evoked potential generated by the spinal nerve under the stimulation of the electric pulse sensed by the feedback sensor 30, so that the spinal cord stimulation system 100 can always apply appropriate stimulation to the spinal nerve. Therefore, this implementation method can effectively avoid the over-stimulation or under-stimulation of the spinal nerve of the patient by the spinal cord stimulation system 100, thereby having a better treatment effect and having less negative impact on the health of the patient.

There are many ways for the control device 10 to adjust the electric pulses, and this disclosure does not specifically limit this.

In one example, the control device 10 is configured to adjust the electric pulse in response to the amplitude of the evoked potential sensed by the feedback sensor 30 being lower than the first threshold value to increase the amplitude of the evoked potential. By comparing whether the amplitude of the sensed evoked potential is lower than the first threshold value, it is possible to accurately determine whether there is under-stimulation, so that the electric pulse can be adjusted accordingly to increase the stimulation of the target point, increase the amplitude of the evoked potential, and improve the treatment effect.

In a particular example, the control device 10 is configured to increase the amplitude of the electric pulse in response to the amplitude of the evoked potential being lower than the first threshold value, so as to increase the amplitude of the evoked potential. It has been proven that increasing the amplitude of the electric pulse can effectively increase the amplitude of the evoked potential, thereby improving the problem of under-stimulation and improving the treatment effect.

In one example, the control device 10 is configured to adjust the electric pulse in response to the amplitude of the evoked potential being higher than the second threshold value to reduce the amplitude of the evoked potential. By comparing whether the amplitude of the sensed evoked potential is higher than the second threshold value, it is possible to accurately determine whether there is overstimulation, so that the electric pulse can be adjusted accordingly to reduce the stimulation to the target point, reduce the amplitude of the evoked potential, and improve the treatment effect.

In a particular example, the control device 10 is configured to reduce the amplitude of the electric pulse in response to the amplitude of the evoked potential being higher than the second threshold value, so as to reduce the amplitude of the evoked potential. It has been proven that reducing the amplitude of the electric pulse can effectively reduce the amplitude of the evoked potential, thereby improving the problem of overstimulation and improving the treatment effect.

Returning to FIG. 1 , the spinal cord stimulation system 100 may further include a patch 40. The patch 40 is suitable for adhering to the patient's skin SK. The control device 10 and the feedback sensor 30 are attached to the patch 40. When in use, the patch 40 may be adhered to the skin SK so that the control device 10 and the feedback sensor 30 can be reliably positioned at the appropriate position; when use is finished, the patch 30 may be removed from the skin SK. This implementation has the advantages of convenient operation and reliable positioning.

There are many ways to implement the patch 40, which is not specifically limited in the present disclosure. A possible implementation is given below in conjunction with Figures 2 to 4. Figures 2 and 3 are schematic diagrams showing the structure of the patch 40 observed from different viewing angles. Figure 4 is a schematic partial cross-sectional view of the patch 40. In addition, Figures 3 and 4 also show a feedback sensor 30 attached to the patch 40.

3 and 4 , the patch 40 includes an adhesive layer 41, and conductive particles defining at least one conductive path are disposed in the adhesive layer 41. The patch 40 is suitable for adhering to the patient's skin SK through the adhesive layer 41. The feedback sensor 30 can be embedded in the adhesive layer 41 to be electrically coupled with the control device 10 (directly or indirectly) through at least one conductive path. It should be noted that a portion (e.g., a surface) of the feedback sensor 30 can be exposed outside the adhesive layer 41 to directly contact the patient's skin SK.

According to the spinal cord stimulation system 100 provided by the present disclosure, the adhesive layer 41 is used to position the patch 40 (as well as the control device 10 and the feedback sensor 30) on the patient's body, and to realize the electrical connection between the feedback sensor 30 and the control device 10, thereby eliminating the need to use additional lines to connect the feedback sensor 30 and the control device 10. Therefore, this implementation method is conducive to simplifying the structure of the spinal cord stimulation system 100 and reducing the complexity of the spinal cord stimulation system 100.

5 and 6 are schematic diagrams showing the structure of the control device 10 viewed from different perspectives. Referring to FIG2 and FIG6 , the control device 10 includes a first electrical connector 11, and the patch 40 also includes a second electrical connector 42 adapted to the first electrical connector 11. The second electrical connector 42 is electrically coupled to the feedback sensor 30 through at least one conductive path.

On the one hand, according to this implementation, since the control device 10 and the patch 40 are connected by the first electrical connector 11 and the second electrical connector 42, when no treatment is performed, only the control device 10 can be removed and the patch 40 can be retained on the patient's body. In this way, the number of times the patch 40 is repeatedly pasted can be reduced. As the number of pastings increases, the adhesion ability of the patch 40 inevitably decreases. After the patch 40 can no longer be reliably fixed on the patient's body surface, the patch 40 needs to be replaced. Therefore, this implementation can extend the service life of the patch 40 and reduce the patient's treatment cost.

On the other hand, according to this implementation, since the control device 10 and the patch 40 are two independent entities connected by a pair of electrical connectors 11, 42, when the adhesion ability of the patch 40 decreases, only the patch 40 can be replaced without replacing the control device 10. Considering that the cost of the control device 10 is higher than that of the patch 40, this implementation can further reduce the treatment cost of the patient.

Referring again to FIGS. 2 to 4 , the patch 40 further includes a covering layer 43, which is stacked with the adhesive layer 41. As an implementation, the covering layer 43 may be made of a flexible, non-adhesive material, for example, the covering layer 43 may be, but is not limited to, a plain cloth, an elastic cloth, or a non-woven fabric. The second electrical connector 42 may be attached to the covering layer 43 so that the patient can peel the second connector 42 and the covering layer 43 off the adhesive layer 41 together.

When in use, the covering layer 43 is located on the side of the adhesive layer 41 away from the patient's skin. The covering layer 43 can prevent the adhesive layer 41 from adhering to the patient's clothes and protect the adhesive layer 41. In addition, since the second electrical connector 42 is attached to the covering layer 43, after the adhesive ability of the adhesive layer 41 decreases, only the adhesive layer 41 can be replaced without replacing the covering layer 43 and the second electrical connector 42. It can be seen that this implementation method can further reduce the treatment cost of the patient.

In a particular example, the feedback sensor 30 can be attached to the cover layer 43, and the feedback sensor 30 can be electrically coupled to the second electrical connector 42 through a line attached to the cover layer 43. In this way, when the adhesive force of the glue layer 41 decreases, the glue layer 41 can be peeled off from the cover layer 43 while retaining the second electrical connector 42 and the feedback sensor 30. In this way, only the glue layer 30 needs to be replaced, and the second electrical connector 42 and the feedback sensor 30 do not need to be replaced. Therefore, this implementation can further reduce the use cost of the patient.

Referring to FIG. 2 and FIG. 6 , the first electrical connector 11 includes a plurality of first electrical connection parts 111, and the second electrical connector 42 includes a plurality of second electrical connection parts 421 respectively adapted to the plurality of first electrical connection parts 111. The plurality of first electrical connection parts 111 are pluggably connected to the plurality of second electrical connection parts 421 to operably realize the electrical coupling and separation of the first electrical connector 11 and the second electrical connector 42. As an example, the plurality of first electrical connection parts 111 may be a plurality of male pins, and the plurality of second electrical connection parts 421 may be a plurality of female pins, or vice versa. Of course, in other examples, the plurality of first electrical connection parts 111 and the plurality of second electrical connection parts 421 may also be implemented in other ways.

In a preferred example, the second electrical connector 42 may include more than two second electrical connection parts 421. In particular, the number of the plurality of second electrical connection parts 421 may be the same as the number of the electrode contacts 21 of the electrode lead 20, for example, 8. The number of the first electrical connection parts 111 is the same as the number of the second electrical connection parts 421.

Conventional electrical connectors usually have only two electrical connections, one of which can be used as a positive pole and the other as a negative pole. If one of the connections and the corresponding circuit fails, the entire product will fail. In the above-mentioned implementation of the present disclosure, the number of first electrical connections 111 and second electrical connections is redundant, so that even if one or more of the first electrical connections 111 or the second electrical connections fail, the normal operation of the entire spinal cord stimulation system 100 can be ensured.

Continuing to refer to Figures 2 and 6, the first electrical connector 11 may further include a first magnetic attraction portion 112, and the second connector 42 may further include a second magnetic attraction portion 422. The first magnetic attraction portion 112 and the second magnetic attraction portion 422 are adapted to provide a magnetic attraction force to maintain the connection between the first electrical connector 11 and the second electrical connector 42. In some embodiments, the first electrical connector 11 may include a plurality of first magnetic attraction portions 112, and the second connector 42 may include a plurality of second magnetic attraction portions 422, and the plurality of first magnetic attraction portions 112 may be adapted to the plurality of second magnetic attraction portions 422, respectively. For example, four first magnetic attraction portions 112 may be distributed at the four corners of the first electrical connector 11; correspondingly, four second magnetic attraction portions 422 are distributed at the four corners of the second electrical connector 42.

There are many ways to implement the first magnetic attraction portion 112 and the second magnetic attraction portion 422, which are not specifically limited in the present disclosure. For example, in some embodiments, both the first magnetic attraction portion 112 and the second magnetic attraction portion 422 can be magnets. For another example, in some embodiments, one of the first magnetic attraction portion 112 and the second magnetic attraction portion 422 is a magnet and the other is a ferromagnetic object.

According to the spinal cord stimulation system 100 provided by the present disclosure, the control device 10 can be firmly attached to the patch 40 through the first magnetic attraction portion 112 and the second magnetic attraction portion 422, and the first electrical connector 11 and the second electrical connector 42 can remain reliably connected. Therefore, this implementation has better reliability. In addition, compared with other methods (for example, the implementation method of fixing the control device 10 to the patch 40 by fasteners), this magnetic attraction method is easy to operate, especially considering that the patch 40 is usually located on the patient's back.

Referring again to FIG. 2 and FIG. 6 , the first electrical connector 11 may further include a first foolproofing portion 113, and the second electrical connector 42 may further include a second foolproofing portion 423. The first foolproofing portion 113 and the second foolproofing portion 423 have matching shapes. As an example, one of the first foolproofing portion 113 and the second foolproofing portion 423 may be a protrusion, and the other may be a groove. Of course, in other examples, the first foolproofing portion 113 and the second foolproofing portion 423 may also have other matching structures.

According to the spinal cord stimulation system 100 provided by the present disclosure, the first foolproofing portion 113 and the second foolproofing portion 423 can effectively prevent the first electrical connector 11 and the second electrical connector 42 from being incorrectly connected. Therefore, this implementation can improve the safety of the spinal cord stimulation system 100.

5 , the control device 10 may further include a button 12, which may be used to operably turn on or off the control device 10. For example, the button 12 may be located on a side of the control device 10 that is away from the patch 40.

There are many ways for the control device 10 to wirelessly transmit electric pulses to the electrode lead 20, which are not specifically limited in the present disclosure. Several possible implementations are given below.

In one example, the control device 10 can transmit electric pulses to the electrode lead 20 by electric field coupling. Electric field coupling, also known as capacitive coupling, is a coupling method caused by the existence of distributed capacitance. Electric field coupling wireless power transmission is a technology that realizes wireless energy transmission through coupling capacitance between metal plates.

Compared with the electromagnetic coupling method, if the electric field coupling method is used to transmit electric pulses, the receiving module of the electrode lead 20 for receiving electric pulses can be made relatively small, which is beneficial to reduce the size of the electrode lead 20, thereby reducing the trauma to the patient during the implantation process. In addition, the use of electric field coupling to transmit electric pulses has the advantage of low alignment requirements. Considering that it is difficult for patients to accurately judge the position of the receiving module of the electrode lead 20 implanted in the body, if a method with higher alignment requirements is adopted, it will be more difficult for the patient to align and the user experience will be poor. In addition, the electric field coupling method also has the advantage of not being easy to generate eddy currents, which makes the receiving module of the electrode lead 20 not easy to heat up, and thus has less negative impact on the patient.

In another example, the control device 10 transmits electric pulses to the electrode lead 20 by ultrasonic coupling. The transmitting module of the control device 10 can convert the electric pulses into ultrasonic waves for output, and the receiving module of the electrode lead 20 can restore the received ultrasonic waves into electric pulses, thereby realizing the transmission of electric pulses by ultrasonic coupling. On the one hand, since ultrasonic waves have better penetrating ability, the transmission of electric pulses by ultrasonic coupling has better transmission stability. On the other hand, compared with magnetic fields or electric fields, ultrasonic waves have less negative impact on the health of patients. On the other hand, ultrasonic waves will not or less affect the evoked potential and/or the sensing of evoked potentials, so it is beneficial for the feedback sensor 30 to more accurately sense the evoked potentials of the spinal nerves, thereby facilitating more precise regulation of electric pulses.

It can be understood that, in addition to the above two exemplary implementations, the control device 10 can also wirelessly transmit electric pulses to the electrode lead 20 in other ways. For example, in some embodiments, the control device 10 can also transmit electric pulses to the electrode lead 20 by electromagnetic induction. For another example, in some embodiments, the control device 10 can also transmit electric pulses to the electrode lead 20 by magnetic field resonance.

Referring again to FIG. 1 , the spinal cord stimulation system 100 further includes one or more external programmers 50. The one or more external programmers 50 are communicatively coupled to the control device 10 via a wired or wireless manner (e.g., Bluetooth). The one or more external programmers 50 are configured for an operator (doctor or patient) to input control instructions and send the control instructions to the control device 10 to program and/or query the control device 10. In some examples, the spinal cord stimulation system 100 may include an external programmer 50a and an external programmer 50b. The external programmer 50a may be used by a doctor, which has a higher control authority, and may be referred to as a doctor programmer. The external programmer 50b may be used by a patient, which has a lower control authority, and may be referred to as a patient programmer.

Through one or more external programmers 50, doctors and/or patients can program and/or query the control device 10. For example, after the electrode lead is implanted, the doctor can program the control device 10 through the doctor programmer 50a to set the patient's treatment strategy. The treatment strategy may include the amplitude and/or frequency of the electric pulse set by the doctor according to the patient's condition, and may also include which electrode contacts 21 of the multiple electrode contacts 21 are used to output the electric pulse. In future follow-up, the doctor can query the control device 10 through the doctor programmer 50a to view the patient's current treatment strategy, and can program the control device 10 to adjust the treatment strategy according to changes in the patient's condition. For another example, the patient can query the control device 10 through the patient programmer 50b to view the status of the control device 10 (for example, the remaining power), or the patient can program the control device 10 through the patient programmer 50b under the doctor's authority control to appropriately adjust the electric pulse.

FIG7 is a schematic diagram showing the structure of at least some modules of the control device 10. As shown in FIG7, the control device 10 includes a processor 13, a pulse generator 14 (e.g., a pulse generating circuit), a transmitting module 15, and a communication module 16. The control device 10 also includes a battery module for providing electrical energy, which is not shown in FIG7. The pulse generator 14 is coupled to the processor 13 to generate electrical pulses under the control of the processor 13. In particular, the processor 13 is capable of acquiring the evoked potential sensed by the feedback sensor 30, and controlling the pulse generator 14 to adjust the electrical pulses according to the sensed evoked potential. The transmitting module 15 is coupled to the pulse sounder 14 to transmit the electrical pulses generated by the pulse generator 14 to the electrode lead 20. The communication module 16 is configured to enable communication between the control device 10 and the electrode lead 20 and the external programmer 50.

Referring again to FIG. 1 , the electrode lead 20 further includes a coupling portion 22 configured to be coupled to the controller 10. In particular, the coupling portion 22 may be located at the tail end of the electrode lead 20, and correspondingly, the plurality of electrode contacts 21 may be located at the head end of the electrode lead 20 opposite to the tail end. More particularly, the tail end of the electrode lead 20 may have a configuration bent toward the control device 10 so that the coupling portion 22 is closer to the control device 10.

FIG8 is a schematic diagram showing the structure of at least some modules of the coupling part 22. As shown in FIG8, the coupling part 22 includes a receiving module 221, a communication module 222 and a distribution module 223. The receiving module 221 is used to couple with the sending module 15 of the control device 10 (for example, electric field coupling, ultrasonic coupling or electromagnetic coupling, etc.) to achieve wireless transmission of electric pulses. The communication module 222 is used to couple with the communication module 16 of the control device 10 to achieve communication between the control device 10 and the electrode lead 20. The distribution module 223 is used to distribute the electric pulses to at least some of the multiple electrode contacts 21.

FIG9 is a schematic partial cross-sectional view of the electrode lead 20. Referring to FIG1 and FIG9, the electrode lead 20 further includes a main body 23, which may be in the shape of an elongated tube and may be made of an insulating material. A plurality of electrode contacts 21 may be attached to the main body 23 at intervals from each other, and the coupling portion 22 and the plurality of electrode contacts 21 may be disposed at opposite ends of the main body 23. The electrode lead 20 may further include a wiring harness 24. The wiring harness 24 is disposed in the main body 22 and is used to transmit electrical pulses from the coupling portion 22 to the plurality of electrode contacts 21.

Fig. 10 is a schematic partial cross-sectional view of an electrode lead according to another embodiment of the present disclosure. The electrode lead provided in this embodiment has many identical or similar elements (components or components) as the electrode lead 20 in the aforementioned embodiment. For the purpose of brevity, identical or similar elements (components or components) are labeled with the same reference numerals, and the corresponding descriptions are omitted.

Referring to FIG10 , the plurality of electrode contacts 21 can be divided into a plurality of electrode contact pairs, each electrode contact pair including a pair of electrode contacts 21a, 21b, namely a first electrode contact 21a and a second electrode contact 21b. The two electrode contacts 21a, 21b in each electrode contact pair define a spacing _t1 , and two adjacent electrode contact pairs define a spacing _t2 . The spacing _t1 is much smaller than the spacing _t2 , for example, the ratio of the spacing _t1 to the spacing _t2 can range from 0.1 to 0.3.

The control device 10 may be configured to perform the following steps a to c.

In step a, in response to the evoked potential departing from a preset interval, the electric pulse is adjusted.

For example, when the evoked potential is sensed to be lower than the first threshold or higher than the second threshold, the control device 10 may first adjust the electric pulse to bring the evoked potential back to the preset interval (ie, between the first threshold and the second threshold).

In step b, in response to sensing that the evoked potential is still out of the preset interval after the first time period after the last adjustment of the electric pulse, the working electrode contact is switched from one of the first electrode contact 21a and the second electrode contact 21b to the other. Here, the working electrode contact is the electrode contact that currently delivers the electric pulse.

Assuming that the current working electrode contact is the first electrode contact 21a, if the evoked potential is still out of the preset interval after the first time period after the last adjustment of the electric pulse, the working electrode contact is switched from the first contact 21a to the second electrode contact 21b. In other words, if the stimulation effect cannot be improved by adjusting the electric pulse, the stimulation effect is improved by adjusting the electrode contact that outputs the electric pulse.

In step c, in response to sensing that the evoked potential is still out of the preset interval after the second time period after the working electrode contact is last adjusted, step a is performed again.

That is, if the stimulation effect cannot be improved by adjusting the working electrode contact, the stimulation effect is improved by adjusting the electric pulse again.

In this implementation, each electrode contact pair corresponds to a target target point instead of each electrode contact. Compared with a single electrode contact, the electrode contact pair covers a wider range. In this way, when the target target point is displaced relative to the working electrode due to a change in the patient's body position, not only can the stimulation effect be improved by adjusting the electric pulse, but also when the adjustment of the electric pulse is ineffective, the displacement of the working electrode contact and the target target point caused by the change in the patient's body position can be compensated by switching the working electrode contact in the electrode contact pair corresponding to the target target point. Therefore, this implementation can more effectively avoid overstimulation or understimulation caused by changes in the patient's body position, thereby having a better therapeutic effect and having less negative impact on the patient's health.

It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, ie, “including but not limited to.” The term “one embodiment” means “at least one embodiment,” and the term “another embodiment” means “at least one additional embodiment.”

It should be noted that the various specific technical features (elements) described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

Those of ordinary skill in the art will appreciate that the units or modules of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this application.

In the several embodiments provided in the present application, it should be understood that the disclosed systems and devices can be implemented in other ways. For example, the device embodiments described above are only schematic. For example, the division of the units or modules is only a logical function division. There may be other division methods in actual implementation, such as multiple units or modules can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, and the indirect coupling or communication connection of units or modules can be electrical or other forms.

In addition, each functional unit or module in each embodiment of the present application may be integrated into one processing unit or module, or each unit or module may exist physically separately, or two or more units or modules may be integrated into one unit or module.

The above is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any changes or substitutions that can be thought of by any technician familiar with the technical field within the technical scope disclosed in the present disclosure should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims (13)

1. A spinal cord stimulation system, characterized in that the spinal cord stimulation system comprises: An electrode lead, adapted to be implanted in a patient's body, comprising a plurality of electrode contacts; a control device, adapted to be placed outside the patient's body, configured to generate electrical pulses and transmit the electrical pulses to the electrode leads in a wireless manner, so that the plurality of electrode contacts of the electrode leads deliver the electrical pulses to the patient's spinal nerves; and a feedback sensor configured to sense the evoked potential generated by the spinal nerve under the stimulation of the electrical pulse, wherein The plurality of electrode contacts are divided into a plurality of electrode contact pairs, each electrode contact pair is configured to correspond to a target point, each electrode contact pair includes a first electrode contact and a second electrode contact that are adjacent to each other, the first electrode contact and the second electrode contact have a spacing t ₁ , two adjacent electrode contact pairs have a spacing t ₂ , and a ratio t ₁ /t ₂ of the spacing t ₁ to the spacing t ₂ ranges from 0.1 to 0.3, The control device is configured to perform the following steps, In step a, in response to the evoked potential departing from the preset interval, adjusting the electric pulse of the working electrode contact in the electrode contact pair; In step b, in response to sensing that the evoked potential is still out of the preset interval after the first time period after the last adjustment of the electric pulse, the working electrode contact currently delivering the electric pulse is switched from one of the first electrode contact and the second electrode contact to the other, so that when the stimulation effect cannot be improved by adjusting the electric pulse, the stimulation effect is improved by adjusting the electrode contact outputting the electric pulse; In step c, in response to sensing that the evoked potential is still out of the preset interval after a second time period after the last adjustment of the working electrode contact, step a is performed again. 2. The spinal cord stimulation system according to claim 1, characterized in that in step a, the control device is configured to adjust the electric pulse in response to the amplitude of the evoked potential being lower than a first threshold value so as to increase the amplitude of the evoked potential. 3. The spinal cord stimulation system according to claim 2, characterized in that in step a, the control device is configured to increase the amplitude of the electric pulse in response to the amplitude of the evoked potential being lower than the first threshold value so as to increase the amplitude of the evoked potential. 4. The spinal cord stimulation system according to claim 1, characterized in that in step a, the control device is configured to adjust the electric pulse in response to the amplitude of the evoked potential being higher than a second threshold value so as to reduce the amplitude of the evoked potential. 5. The spinal cord stimulation system according to claim 4, characterized in that in step a, the control device is configured to reduce the amplitude of the electric pulse in response to the amplitude of the evoked potential being higher than the second threshold value so as to reduce the amplitude of the evoked potential. 6. The spinal cord stimulation system according to any one of claims 1 to 5, characterized in that the spinal cord stimulation system also includes a patch, which is suitable for adhering to the patient's skin, and the feedback sensor and the control device are attached to the patch. 7. The spinal cord stimulation system according to claim 6 is characterized in that the patch includes an adhesive layer, in which conductive particles defining at least one conductive path are provided, the patch is suitable for being adhered to the patient's skin through the adhesive layer, and the feedback sensor is embedded in the adhesive layer to be electrically coupled with the control device through the at least one conductive path. 8. The spinal cord stimulation system according to claim 7 is characterized in that the control device includes a first electrical connector, and the patch also includes a second electrical connector adapted to the first electrical connector, and the second electrical connector is electrically coupled to the feedback sensor through the at least one conductive path. 9. The spinal cord stimulation system according to claim 8, characterized in that the patch also includes a covering layer overlapping the adhesive layer, and the second electrical connector is attached to the covering layer. 10. The spinal cord stimulation system according to claim 9 is characterized in that the first electrical connector and the second electrical connector respectively include a first magnetic attraction portion and a second magnetic attraction portion that match each other, and the first magnetic attraction portion and the second magnetic attraction portion cooperate to provide a magnetic attraction force to maintain the connection between the first electrical connector and the second electrical connector. 11. The spinal cord stimulation system according to claim 10, characterized in that the first electrical connector and the second electrical connector respectively include a first fool-proof portion and a second fool-proof portion that are adapted to each other. 12. The spinal cord stimulation system according to any one of claims 1 to 5, characterized in that the control device transmits the electric pulse to the electrode lead by electric field coupling or ultrasonic coupling. 13. A spinal cord stimulation system according to any one of claims 1 to 5, characterized in that the spinal cord stimulation system also includes an external programmer, which is configured to allow an operator to input control instructions and send the control instructions to the control device to program and/or query the control device.