CN115531724A - Electrode lead and spinal cord stimulation system - Google Patents
Electrode lead and spinal cord stimulation system Download PDFInfo
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- CN115531724A CN115531724A CN202211214162.6A CN202211214162A CN115531724A CN 115531724 A CN115531724 A CN 115531724A CN 202211214162 A CN202211214162 A CN 202211214162A CN 115531724 A CN115531724 A CN 115531724A
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- 210000000278 spinal cord Anatomy 0.000 title claims abstract description 34
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- A—HUMAN NECESSITIES
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- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36062—Spinal stimulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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- A—HUMAN NECESSITIES
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
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- A—HUMAN NECESSITIES
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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Abstract
The present disclosure relates to an electrode lead and a spinal cord stimulation system. The electrode lead includes a plurality of electrode contact sets configured to deliver electrical pulses generated by a control device of the spinal cord stimulation system to spinal nerves of a patient, wherein the plurality of electrode contact sets are spaced apart along a length of the electrode lead, each electrode contact set including a plurality of electrode contacts spaced apart along a circumference of the electrode lead. According to the electrode lead provided by the present disclosure, in the same electrode contact group, the orientations of different electrode contacts are different, and therefore, the coverage of stimulation signals generated by different electrode contacts is also different. Compared with the traditional electrode lead with the annular electrode contacts, the coverage range of the single electrode contact in each electrode contact group is smaller, so that the target point can be accurately covered, and other parts of the spinal nerves can not be stimulated or can be stimulated less, and accurate directional stimulation can be realized.
Description
Technical Field
The disclosure relates to the technical field of medical instruments, in particular to an electrode lead and a spinal cord stimulation system with the same.
Background
With the continuous advancement of medical technology, therapies employing implantable neurostimulation systems are becoming more and more common. As an implantable neurostimulation system, a Spinal Cord Stimulation (SCS) system is applied as a pain relief means for patients. Conventional spinal cord stimulation systems typically include a control device (e.g., including a pulse generator and a battery, etc.) and an electrode lead. In operation, the plurality of electrode contacts of the electrode lead deliver electrical pulses generated by the control device to the spinal nerves of the patient to relieve pain in the patient.
Conventional spinal cord stimulation systems typically employ electrode contacts in the form of rings. The stimulation signals generated by the electrode contacts have isotropy and a large coverage range. Therefore, the stimulation signals generated by such electrode contacts inevitably cover, in addition to the target, undesired parts of the spinal nerves, which may negatively affect the health of the patient and even induce other diseases. Furthermore, such electrode contacts typically consume a relatively high amount of power due to the relatively large coverage of the generated stimulation signal. In particular for some spinal cord stimulation systems that require the control device to be implanted in the patient, higher power consumption means a larger battery and thus control device volume, which can increase patient trauma during delivery and increase surgical difficulty.
Disclosure of Invention
In view of this, the present disclosure provides an electrode lead capable of generating a stimulation signal to cover a target site more precisely and a spinal cord stimulation system having the electrode lead.
In a first aspect, the present disclosure provides an electrode lead for a spinal cord stimulation system. The present disclosure provides an electrode lead including a plurality of electrode contact sets. The plurality of electrode contact sets are configured to deliver electrical pulses generated by a control device of the spinal stimulation system to spinal nerves of a patient. The plurality of electrode contact groups are distributed at intervals along the length direction of the electrode lead. Each electrode contact group includes a plurality of electrode contacts distributed at intervals along a circumferential direction of the electrode lead.
According to the electrode lead provided by the present disclosure, different electrode contacts in the same electrode contact group are oriented differently, and therefore the coverage of stimulation signals generated by different electrodes is also different. Compared with the ring-shaped electrode contacts in the conventional electrode lead, in the electrode lead provided by the disclosure, the coverage of the single electrode contact in each electrode contact group is smaller, so that the target point can be accurately covered while other parts of the spinal nerves can not be stimulated or less can be stimulated, and further, accurate directional stimulation can be realized. Therefore, the electrode lead provided by the disclosure can reduce side effects caused by redundant stimulation, and is more beneficial to the health of patients. Furthermore, the smaller coverage of the individual electrode contacts and thus the lower power consumption, compared to conventional annular electrode contacts, makes it possible to reduce the size of the battery and thus of the control device. Therefore, for a spinal cord stimulation system needing to implant a control device into a patient, the electrode lead provided by the disclosure is beneficial to reducing the trauma to the patient during the implantation process and reducing the operation difficulty.
With reference to the first aspect, in one possible implementation manner, the plurality of electrode contacts of each electrode contact group are distributed in a staggered manner in the circumferential direction of the electrode lead with the plurality of electrode contacts of the adjacent electrode contact group. That is, the plurality of electrodes of each electrode contact group are respectively opposed to the spaces between the plurality of electrodes of its adjacent electrode contact group. Alternatively, the gaps between the plurality of electrodes of each electrode contact set and the plurality of electrodes of its respective adjacent electrode contact set are substantially collinear in the length direction of the electrode lead.
This configuration has a number of advantages. On the one hand, with this configuration, even a smaller pitch of the adjacent electrode contact groups in the length direction of the electrode lead does not cause the portion of the electrode lead to which the electrode contact group is attached to become excessively stiff. If the portion of the electrode lead to which the electrode contact set is attached is excessively stiff, implantation of the electrode lead is not facilitated. That is, with this configuration, it is possible to significantly reduce the distance between adjacent electrode contact groups while ensuring that the portion of the electrode lead to which the electrode contact groups are attached is not excessively stiff. The closer the distance between the adjacent electrode contact groups is, the more comprehensive and dense the whole covered area formed by the plurality of electrode contact groups is, which is beneficial to more comprehensively covering more target points. On the other hand, according to this configuration, the areas covered by the adjacent two electrode contact sets are complementary to each other, i.e., the stimulation area corresponding to each gap in each electrode contact set can be covered by the electrode contact opposite to the gap in the adjacent electrode contact set. This allows the width of each electrode contact (i.e., the dimension in the circumferential direction of the electrode lead) to be smaller, thereby contributing to a reduction in the cost of the individual contacts and further contributing to the maintenance of the bendability of the electrode lead.
With reference to the first aspect, in one possible implementation manner, any two adjacent electrode contacts of each electrode contact group define a first pitch t in the circumferential direction of the electrode lead 1 Any two adjacent electrode contact groups define a second interval t in the length direction of the electrode lead 2 Each electrode contact defines a width w in a circumferential direction of the electrode lead and a length h in a length direction of the electrode lead.
Such a staggered distribution between adjacent sets of electrode contacts allows the distance between them to be relatively small, i.e. allows a second distance t between them 2 The ratio to the length h of the electrode contact is small, for example, the ratio may range from 0.4 to 1.2, preferably from 0.4 to 0.8. Furthermore, the staggered distribution allows adjacent electrodesThe coverage between the contact sets is complementary, thereby allowing each electrode contact to have a smaller width, i.e. allowing a first pitch t between adjacent electrode contacts in the same electrode contact set 1 The ratio to the width w of each electrode contact is relatively large, and may range, for example, from 0.6 to 1.4, and more preferably from 0.8 to 1.2. The electrode lead adopting the structure is proved to cover more comprehensive target spots, more dense coverage areas and more excellent flexibility.
The present disclosure is not particularly limited with respect to the number of electrode contacts included in each electrode contact group. In one possible implementation, the number of the plurality of electrode contacts per electrode contact group is two. In a particular implementation, the number of the plurality of electrode contacts of each electrode contact group is preferably three. If each electrode contact group only comprises two electrode contacts, in order to ensure that the whole coverage range of all the contacts (i.e. two electrode contacts) in each contact group has proper omnidirectionality, each electrode contact needs to cover a larger range, which is not favorable for the accuracy of the stimulation signal generated by each electrode contact. If each electrode contact group includes four or more electrode contacts, the complexity of the electrode lead is greatly increased. In contrast, setting the number of electrodes per electrode contact group to three can ensure both the accuracy of the stimulation signal generated by each electrode contact and the relatively low complexity of the electrode lead.
With reference to the first aspect, in one possible implementation, the electrode lead further comprises a body member in the shape of an elongated tube, wherein the plurality of electrode contact sets are attached to the body member, and a wire harness extending within the body member, the wire harness being configured to deliver electrical pulses to the plurality of electrode contact sets.
The body member may be made of an insulating material. A plurality of electrode contact sets are attached to a body member that positions and supports the electrode contacts. The pencil can wear to locate in the main part spare, and the main part spare can play the guard action to the pencil.
With reference to the first aspect, in one possible implementation manner, the number of the plurality of electrode contacts of each electrode contact group is n, the electrode lead further includes a plurality of gating modules respectively corresponding to the plurality of electrode contact groups, and each gating module is configured to selectively communicate 0 to n electrode contacts of its corresponding electrode contact group with the wire harness.
Since each electrode contact group includes a plurality of electrode contacts, the total number of electrode contacts included in the electrode lead is large. If each electrode contact corresponds to a line in the wire harness, the complexity of the wire harness is increased, and the diameter of the wire harness is increased to increase the diameter of the electrode lead. The larger diameter of the electrode lead is detrimental to the implantation of the electrode lead, increasing patient trauma. According to the electrode lead provided by the present disclosure, each gating module is configured to selectively communicate 0 to all of the electrode contacts of its corresponding electrode contact group with the wire harness, such that each electrode contact group corresponds to one line in the wire harness rather than each electrode contact. Therefore, this implementation is advantageous in reducing the complexity of the wire harness, and in reducing the diameter of the wire harness and thus the diameter of the electrode lead.
In a second aspect, the present disclosure also provides a spinal cord stimulation system. The present disclosure provides a spinal cord stimulation system comprising: an electrode lead as provided in the above first aspect; and a control device configured to generate and couple with the electrode lead in a manner that enables delivery of the electrical pulse to the electrode lead.
Due to the adoption of the electrode lead provided by the aspect, the spinal cord stimulation system provided by the disclosure can not or less stimulate other parts of spinal nerves while accurately covering a target point, so that accurate directional stimulation can be realized. Therefore, the spinal cord stimulation system provided by the disclosure can reduce side effects caused by redundant stimulation, and is more beneficial to the health of patients. In addition, the spinal cord stimulation system provided by the present disclosure consumes less power due to the electrode lead provided by the above aspect of the present disclosure, which makes it possible to reduce the size of the battery and thus the size of the control device. Especially for the situation that the control device needs to be implanted into the body of a patient, the spinal cord stimulation system provided by the disclosure is beneficial to reducing the trauma of the implantation process to the patient and reducing the operation difficulty.
With reference to the second aspect, in one possible implementation, the spinal cord stimulation system further includes an external programmer, wherein the external programmer is configured to take control instructions input by an operator and send the control instructions to the control device to program and/or interrogate the control device.
Through an external programmer, a physician and/or patient can program and/or interrogate the control device. For example, a physician may program the control device, via an external programmer, after implantation to set a patient's treatment strategy. The treatment strategy may include the amplitude and/or frequency of the electrical pulses, etc., as set by the physician according to the patient's condition, and may also include which of the plurality of electrode contacts are used to output the electrical pulses. At a follow-up visit, the physician may interrogate the control device via an external programmer to view the patient's current treatment strategy, and may program the control device to adjust the treatment strategy in accordance with changes in the patient's condition. As another example, the patient can query the control device through an external programmer to see the status of the control device (e.g., remaining charge), or the patient can program the control device through an external programmer under the authority of a physician to adjust the electrical pulses appropriately.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings needed to be used in the embodiments will be briefly described below.
It is appreciated that the following drawings depict only certain embodiments of the disclosure and are therefore not to be considered limiting of its scope, for those skilled in the art will be able to derive additional related drawings therefrom without the benefit of the inventive faculty.
It should be understood that the same or similar reference numerals are used throughout the figures to indicate the same or similar elements (components or constituents).
It should be understood that the drawings are merely schematic and that the sizes and proportions of elements (components or parts) in the drawings are not necessarily precise.
Fig. 1 is a schematic structural diagram of a spinal cord stimulation system according to an embodiment of the present disclosure.
Fig. 2 is a schematic diagram of the structure of an electrode lead of the spinal cord stimulation system of fig. 1.
Fig. 3 is an exploded schematic view of a portion of the electrode lead in fig. 2.
Fig. 4 is a schematic view illustrating a structure in which an electrode contact group of the electrode lead in fig. 2 is developed in a circumferential direction of the electrode lead.
Fig. 5 is a longitudinal sectional view of a portion of the electrode lead in fig. 2.
Fig. 6 isbase:Sub>A sectional view taken along linebase:Sub>A-base:Sub>A of fig. 5.
Fig. 7 is a schematic structural view of a gating module illustrating electrode leads in fig. 2.
Fig. 8 is a schematic structural view showing a connector of the electrode lead in fig. 2 and a microcircuit module.
Fig. 9 is a schematic structural view of a portion of an electrode lead according to another embodiment of the present disclosure.
Fig. 10 is a schematic view illustrating a structure in which an electrode contact group of the electrode lead in fig. 9 is expanded in the circumferential direction of the electrode lead.
Fig. 11 is a schematic structural view of a portion of an electrode lead according to another embodiment of the present disclosure.
Fig. 12 is a schematic view illustrating a structure in which an electrode contact group of the electrode lead in fig. 11 is expanded in the circumferential direction of the electrode lead.
Detailed Description
The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present disclosure. It is to be understood that the described embodiments are merely illustrative of some, but not all embodiments of the disclosure.
Fig. 1 is a schematic structural diagram of a spinal cord stimulation system 100 according to an embodiment of the present disclosure. Note that, in fig. 1, reference symbol SC is used to indicate the spinal cord of the patient.
As shown in fig. 1, the spinal cord stimulation apparatus 100 includes a control device 10 and an electrode lead 20. The control device 10 is configured to generate electrical pulses. In the present disclosure, the electric pulse may be a current pulse or a voltage pulse. The control device 10 is also configured to couple with the electrode lead 20 in a manner that enables delivery of electrical pulses to the electrode lead 20. As an example, the control device 10 may be directly electrically connected to the electrode lead 20. The electrode lead 20 includes a plurality of electrode contact groups 21. The plurality of electrode contact sets 21 are configured to deliver electrical pulses generated by the control device 10 to the spinal nerves of the patient.
Fig. 2 is a schematic view of the structure of the electrode lead 20. Fig. 3 is an exploded schematic view of a portion of the electrode lead 20. Fig. 4 is a schematic diagram showing the structure of the electrode contact group 21 spreading along the circumferential direction of the electrode lead 20, which most clearly shows the plurality of contact groups 21 and the distribution of the plurality of electrode contacts contained therein. It should be noted that, in fig. 2 and 3, and in other drawings of the present disclosure, the arrow L may be used to indicate the length direction of the electrode lead 20, and the arrow C may be used to indicate the circumferential direction of the electrode lead.
As shown in fig. 2 and 3, the plurality of electrode contact groups 21 are distributed at intervals along the length direction of the electrode lead 20. Each electrode contact set 21 includes a plurality of electrode contacts 211,212,213 spaced apart along the circumference of the electrode lead 20.
It should be noted that, although only four electrode contact sets 21 are shown in the embodiments shown in fig. 1 to 4, in other embodiments of the present disclosure, the electrode lead 20 may include other numbers of electrode contact sets 21, for example, 2, 6 or other numbers. Of course, in some embodiments, the number of electrode contact sets 21 may also be an odd number.
Furthermore, it should be noted that although in the embodiment shown in FIG. 3, each electrode contact set 21 includes three electrode contacts 211,212,213, in other embodiments of the present disclosure, each electrode contact set 21 may include other numbers of electrode contacts, for example, 2, 4, or more.
According to the electrode lead 20 provided by the present disclosure, the orientations of the different electrode contacts 211,212,213 are different in the same electrode contact group 21, and therefore the coverage of the stimulation signals generated by the different electrode contacts 211,212,213 is also different. Compared with the conventional electrode lead with the annular electrode contact, in the electrode lead 20 provided by the present disclosure, the coverage of a single electrode contact is smaller and has a more accurate orientation, so that other parts of the spinal nerves can not or less be stimulated while the target point is accurately covered, and thus accurate directional stimulation can be realized. Therefore, the electrode lead 20 provided by the present disclosure can reduce the side effects caused by the redundant stimulation, and is more beneficial to the health of the patient. Furthermore, in the electrode lead 20 provided in the present disclosure, the coverage of the individual electrode contacts is smaller and thus the power consumption is smaller, compared to the conventional ring-shaped electrode contacts, which makes it possible to reduce the size of the battery and thus the control device 10. It can be seen that for situations where it is desirable to implant the control device 10 into a patient, the use of an electrode lead 20 with the present disclosure facilitates reducing trauma to the patient and reduces surgical difficulty during the implantation procedure.
In addition, due to the adoption of the electrode leads 20, the spinal cord stimulation system 100 provided by the present disclosure can not or less stimulate other parts of the spinal nerves while accurately covering the target spot, thereby realizing accurate directional stimulation. Therefore, the spinal cord stimulation system 100 provided by the present disclosure can reduce the side effects caused by the redundant stimulation, and is more beneficial to the health of the patient. Furthermore, the spinal cord stimulation system 100 provided by the present disclosure consumes less power due to the use of the electrode leads 20, which makes it possible to reduce the size of the battery and thus the control device 10. Particularly in situations where the control device 10 needs to be implanted in a patient, the spinal cord stimulation system 100 provided by the present disclosure is advantageous in reducing trauma to the patient during the implantation process and reducing the difficulty of the surgery.
Fig. 5 is a longitudinal sectional view of a portion of the electrode lead 20. Referring to fig. 5, the electrode lead 20 further includes a body member 22 and a wire harness 23. The body member 22 may be elongate and tubular. The wiring harness 23 may extend in the main body member 22. A plurality of electrode contact sets 21 are attached to the body piece 22. The wiring harness 23 is configured to transmit electrical pulses generated by the control device 10 to the plurality of electrode contact sets 21. In some examples, the body member 22 may be made of an insulating material to facilitate insulation of the various electrode contacts from one another. In the electrode lead 20 provided by the present disclosure, a plurality of electrode contact groups 21 are attached to a main body member 22, and the main body member 22 can position and support these electrode contact groups 21. The wire harness 23 may be inserted into the main body member 22, and the main body member 22 may protect the wire harness 23.
Fig. 6 isbase:Sub>A sectional view taken along linebase:Sub>A-base:Sub>A in fig. 5. Referring to fig. 5 and 6, the electrode lead 20 further includes a plurality of gating modules 24, the plurality of gating modules 24 corresponding to the plurality of electrode contact groups 21, respectively. Each gating module 24 is electrically connected to the wire harness 23 and to the plurality of electrode contacts of its corresponding electrode contact set 21. Each gating module 24 is configured to selectively communicate 0 to all of the electrode contacts in its corresponding electrode contact set 21 with the wiring harness 23. Assuming that the number of electrode contacts included in each electrode contact group 21 is n, the gating module 24 is configured to disconnect all of the n electrode contacts from the wire harness 24 or to communicate 1 to n electrode contacts with the wire harness 23.
Since each electrode contact group 21 includes a plurality of electrode contacts, the total number of electrode contacts included in the electrode lead 20 is large. If each electrode contact corresponds to one of the wires in the wire harness, the wire harness is complicated, and the diameter of the wire harness 23, and thus the diameter of the electrode lead 20, is increased. A larger electrode lead diameter 20 is detrimental to the implantation of the electrode lead 20, increasing patient trauma. According to the electrode lead 20 provided by the present disclosure, each gating module 24 is configured to selectively communicate 0 to all of the electrode contacts of its corresponding electrode contact group 21 with the wire harness 23, such that each electrode contact group 21 corresponds to one line in the wire harness 23 instead of each electrode contact. Therefore, this implementation is advantageous in reducing the complexity of the wire harness 23, and in reducing the diameter of the wire harness 23 and thus the electrode lead 20.
Fig. 7 is a schematic diagram showing the structure of the gating module 24. Referring to fig. 7, in one example, the gating module 24 includes a gating circuit 241, a plurality of electrode pads P1, P2, P3, and a harness pad P4. The gate circuit 241 is electrically connected to the plurality of electrode contacts 211,212,213 of the corresponding electrode contact set 21 through a plurality of electrode pads P1, P2, P3, respectively, and to the harness 24 through a harness pad P4. The specific implementation of the gating circuit 241 is not particularly limited as long as it can selectively communicate 0 to all of the plurality of electrode contacts of the corresponding electrode contact group 21 with the wire harness 24. As one example, the gating circuit 241 may include a plurality of switches.
Referring back to fig. 2, the electrode lead 20 may further include a connector 25 and a microcircuit module 26, both of which may be located at a trailing end of the electrode lead 20, and the plurality of electrode contact sets 21 may be located at a leading end of the electrode lead 20 opposite the trailing end. Fig. 8 is a schematic diagram showing the structure of the connector 25 and the microcircuit module 26. As shown in fig. 8, microcircuit module 26 includes a communications module 261, a distribution module 262, a connector pad P5, and a harness pad P6. The communication module 261 is electrically connected to the connector 25 through a connector pad P5. The dispensing module 262 is electrically connected to the wire harness 23 via a wire harness solder point P6. The communication module 261 is configured to communicate with the control device 10. The distribution module 262 is configured to distribute electrical pulses to at least some of the plurality of electrode contact sets 21.
In this embodiment, the electrode lead 20 is connected to the control device 10 by a connector 25 to allow electrical pulses generated by the control device 10 to be transmitted to the electrode lead 20. Of course, in other embodiments of the present disclosure, the control device 10 and the electrode lead 20 may not be connected to each other, and the control device 10 may deliver the electric pulse to the electrode lead 20 in a wireless manner. In this implementation, the electrode lead 20 may not have the connector 25 and the microcircuit module 26 but have a coupling portion capable of wireless coupling with the control device 10.
Referring back to fig. 1, spinal cord stimulation system 100 also includes one or more external programmers 30. One or more external programmers 30 are communicatively coupled to control device 10 via wired or wireless means (e.g., bluetooth). The one or more external programmers 30 are configured for an operator (physician or patient) to enter and send control instructions to the control device 10 to program and/or interrogate the control device 10. In some examples, spinal cord stimulation system 100 may include an external programmer 30a and an external programmer 30b. External programmer 30a may be available to the physician with higher control authority, which may be referred to as a physician programmer. The external programmer 30b may be for use by the patient, has lower control authority, and may be referred to as a patient programmer.
Through one or more external programmers 30, a physician and/or patient can program and/or interrogate the control device 10. For example, a physician may program the control device 10 via the physician programmer 30a after implantation of an electrode lead to set a treatment strategy for the patient. The treatment strategy may include the amplitude and/or frequency of the electrical pulses set by the physician according to the patient's condition, etc., and may also include which electrode contacts 21 of the plurality of electrode contacts 21 are used to output the electrical pulses. At a follow-up visit, a physician may query the control device 10 via the physician programmer 30a to view the patient's current treatment strategy, and may program the control device 10 to adjust the treatment strategy in accordance with changes in the patient's condition. As another example, the patient may query the control device 10 through the patient programmer 30b to view the status (e.g., remaining charge) of the control device 10, or the patient may program the control device 10 through the patient programmer 30b under the authority of the physician to adjust the electrical pulses appropriately.
With continued reference to fig. 1, the control device 10 may include a processor 11, a pulse generator 12 (e.g., a pulse generating circuit), and a communication module 13 (e.g., a communication circuit). The pulse generator 12 may be configured to generate electrical pulses under the control of the processor 11. The communication module 13 may be configured to communicate with one or more external programmers 30 and electrode leads 20 under the control of the processor 11.
With continued reference to fig. 1, an electrode lead 20 is at least partially (at least the portion provided with the plurality of electrode contact sets 21) implanted in the spinal epidural space of the patient to apply electrical stimulation to the spinal nerves of the patient. In one example, both the control device 10 and the electrode lead 20 are implanted within the body of the patient. In another example, only the electrode lead 20 is implanted in the patient's body, while the control device 10 is placed outside the patient's body, and the control device 10 wirelessly transmits electrical pulses to the electrode lead 20, for example, by means of electric field coupling or by means of electromagnetic induction.
Fig. 9 is a schematic structural view of a portion of an electrode lead 20 according to another embodiment of the present disclosure. Fig. 10 is a schematic view illustrating a structure in which the electrode contact group 21 of the electrode lead 20 in fig. 9 is expanded in the circumferential direction of the electrode lead 20. The electrode lead 20 provided in this embodiment is substantially the same as the electrode lead 20 provided in the previous embodiment. For the sake of brevity, the same or similar elements are given the same reference numerals, and the related description is omitted.
Referring to fig. 9 and 10, in this embodiment, the plurality of electrode contacts 211,212,213 of each electrode contact group 21 are alternately distributed with the plurality of electrode contacts 211,212,213 of the adjacent electrode contact group 21 in the circumferential direction of the electrode lead 20. That is, the plurality of electrode contacts 211,212,213 of each electrode contact group 21 are opposed to the spaces between the plurality of electrode contacts 211,212,213 of its adjacent electrode contact group 21, respectively. Alternatively, the gaps between the plurality of electrodes 211,212,213 of each electrode contact set 21 and the plurality of electrodes 211,212,213 of its adjacent electrode contact set 21, respectively, are substantially collinear along the length of the electrode lead 20.
For example, referring to fig. 10, in a pair of adjacent electrode contact sets 21a,21b, the electrode contact 211a is opposed to the gap between the pair of electrode contacts 211b,212b, or, in the length direction of the electrode lead 20, the electrode contact 211a is substantially collinear with the gap between the pair of electrode contacts 211b, 212b. Similarly, the electrode contact 213b is opposite the gap between the pair of electrode contacts 212a,213a, or, in the direction of the length of the electrode lead 20, the electrode contact 213b is substantially collinear with the gap between the pair of electrode contacts 212a, 213a.
This configuration has a number of advantages. On the one hand, with this configuration, the adjacent electrode contact groups 21 do not cause the portion of the electrode lead 20 to which the electrode contact group 21 is attached to become excessively stiff in the length direction of the electrode lead 20 even with a smaller pitch. If the portion of the electrode lead 20 to which the electrode contact group 21 is attached is excessively stiff, implantation of the electrode lead 20 is not facilitated. That is, with this configuration, the distance between the adjacent electrode contact groups 21 can be significantly reduced while ensuring that the portions of the electrode leads 20 to which the electrode contact groups 21 are attached are not excessively stiff. The closer the distance between the adjacent electrode contact sets 21 is, the more comprehensive and dense the covered area of the whole body formed by the plurality of electrode contact sets 21 is, which is beneficial to more comprehensively covering more target points. On the other hand, according to such a configuration, the areas covered by the adjacent two electrode contact sets 21 are complementary to each other, i.e., the stimulation area corresponding to each gap in each electrode contact set 1 can be covered by the electrode contact opposite to the gap in the adjacent electrode contact set 21. This allows the width of each electrode contact (i.e., the dimension in the circumferential direction of the electrode lead 20) to be smaller, thereby contributing to a reduction in the cost of a single electrode contact and further contributing to the maintenance of the bendability of the electrode lead 20.
With continued reference to fig. 10, any two adjacent electrode contacts of each electrode contact 21 define a first pitch t in the circumferential direction of the electrode lead 20 1 Any two adjacent electrode contact groups 21 define a second distance t in the length direction of the electrode lead 20 2 Each electrode contact defines a width w in the circumferential direction of the electrode lead 20 and a length h in the length direction of the electrode lead 20.
This staggered distribution between adjacent sets of electrode contacts 21 allows the distance between them to be relatively small, i.e., allows the second distance t between them 2 The ratio to the length h of the electrode contact is small, for example, it may range between 0.4 and 1.2, preferably between 0.4 and 0.8. Furthermore, this staggered distribution allows for a complementary coverage between adjacent electrode contact sets 21, allowing each electrode contact to have a smaller width, i.e. allowing for a first pitch t between adjacent electrode contacts in the same electrode contact set 21 1 The ratio to the width w of each electrode contact is relatively large, and may range, for example, from 0.6 to 1.4, and more preferably from 0.8 to 1.2. It is proved that the electrode lead 20 having such a structure covers a relatively entire target area, has a relatively dense coverage area, and is excellent in flexibility.
The present disclosure is not particularly limited with respect to the number of electrode contacts included in each electrode contact group 21. In one possible implementation, the number of the plurality of electrode contacts of each electrode contact group 21 is two. In one particular implementation, the number of the plurality of electrode contacts of each electrode contact set 21 is preferably three. If each electrode contact group 21 only includes two electrode contacts, in order to ensure that the whole coverage range of all the contacts (i.e. two electrode contacts) in each electrode contact group 21 has proper omnidirectionality, each electrode contact needs to cover a larger range, which is not favorable for the accuracy of the stimulation signal generated by each electrode contact. If each electrode contact group 21 includes four or more electrode contacts, the complexity of the electrode lead 20 is greatly increased. In contrast, setting the number of electrodes per electrode contact group 21 to three ensures both the accuracy of the stimulation signal generated by each electrode contact and the relatively low complexity of the electrode lead 20.
Fig. 11 is a schematic structural view of a portion of an electrode lead 20 according to another embodiment of the present disclosure. Fig. 12 is a schematic view illustrating a structure in which the electrode contact group 21 of the electrode lead 20 in fig. 11 is developed in the circumferential direction of the electrode lead 20. The electrode lead 20 provided in this embodiment is substantially the same as the electrode lead 20 provided in the previous embodiment. For the sake of brevity, the same or similar elements are denoted by the same reference numerals, and the related description is omitted. Referring to fig. 11 and 12, in some embodiments, each electrode contact set 21 may include only two electrode contacts 211,212.
It is understood that, as used in this disclosure, the term "include" and variations thereof are open-ended, i.e., "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, in the above embodiments, the various features (elements) described in the above embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, the disclosure does not separately describe various possible combinations.
It should be understood that multiple components and/or portions can be provided by a single integrated component or portion. Alternatively, a single integrated component or part may be divided into separate multiple components and/or parts. The disclosure "a" or "an" to describe an element or portion is not intended to exclude other elements or portions.
The above description is only for the specific embodiments of the present disclosure, but the scope of the present disclosure is not limited thereto, and any person skilled in the art can conceive of changes or substitutions within the technical scope of the present disclosure, and shall be covered by the scope of the present disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.
Claims (10)
1. An electrode lead of a spinal cord stimulation system, characterized in that the electrode lead comprises a plurality of electrode contact sets configured to deliver electrical pulses generated by a control device of the spinal cord stimulation system to spinal nerves of a patient, wherein the plurality of electrode contact sets are distributed at intervals along a length direction of the electrode lead, each electrode contact set comprising a plurality of electrode contacts distributed at intervals along a circumference of the electrode lead.
2. The electrode lead according to claim 1, wherein the plurality of electrode contacts of each electrode contact group are distributed to be staggered from the plurality of electrode contacts of an adjacent electrode contact group in a circumferential direction of the electrode lead.
3. The electrode lead according to claim 2, wherein any two adjacent electrode contacts of each electrode contact group define a first pitch t in a circumferential direction of the electrode lead 1 Any two adjacent electrode contact groups define a second interval t in the length direction of the electrode lead 2 Each electrode contact defining a width w in a circumferential direction of the electrode lead and being in a length direction of the electrode leadA length h, wherein the first distance t 1 The ratio of the width w to the first pitch t is in the range of 0.6 to 1.4 2 The ratio to the length h ranges from 0.4 to 1.2.
4. The electrode lead of claim 3, wherein the first pitch t 1 The ratio of the width w to the first pitch t is in the range of 0.8 to 1.2 2 The ratio to the length h ranges from 0.4 to 0.8.
5. The electrode lead according to any one of claims 1 to 4, wherein the number of the plurality of electrode contacts of each electrode contact group is two.
6. The electrode lead according to any one of claims 1 to 4, wherein the number of the plurality of electrode contacts of each electrode contact group is three.
7. The electrode lead according to any one of claims 1 to 4, further comprising a main body member in the shape of an elongated tube to which the plurality of electrode contact sets are attached and a wire harness extending within the main body member, the wire harness being configured to deliver the electrical pulse to the plurality of electrode contact sets.
8. The electrode lead of claim 7, wherein the plurality of electrode contacts of each electrode contact group is n in number, the electrode lead further comprising a plurality of gating modules corresponding to the plurality of electrode contact groups, respectively, each gating module configured to selectively connect 0 to n electrode contacts of its corresponding electrode contact group with the wire harness.
9. A spinal cord stimulation system, comprising:
the electrode lead of any one of claims 1 to 8; and
a control device configured to generate and couple with the electrode lead in a manner capable of delivering the electrical pulse to the electrode lead.
10. The spinal cord stimulation system according to claim 9, further comprising an external programmer, wherein said external programmer is configured to take operator input control instructions and send said control instructions to said control device to program and/or interrogate said control device.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| CN202210794037 | 2022-07-05 | ||
| CN2022107940370 | 2022-07-05 |
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| CN115531724A true CN115531724A (en) | 2022-12-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202211214162.6A Pending CN115531724A (en) | 2022-07-05 | 2022-09-30 | Electrode lead and spinal cord stimulation system |
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Cited By (1)
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| CN116212237A (en) * | 2023-03-15 | 2023-06-06 | 北京新云医疗科技有限公司 | Electrode lead, electro-stimulation system having the same, and method of manufacturing the electrode lead |
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