CN115531724B - Electrode lead and spinal cord stimulation system - Google Patents
Electrode lead and spinal cord stimulation system Download PDFInfo
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- CN115531724B CN115531724B CN202211214162.6A CN202211214162A CN115531724B CN 115531724 B CN115531724 B CN 115531724B CN 202211214162 A CN202211214162 A CN 202211214162A CN 115531724 B CN115531724 B CN 115531724B
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- 230000000638 stimulation Effects 0.000 title claims abstract description 55
- 210000000278 spinal cord Anatomy 0.000 title claims abstract description 35
- 210000001032 spinal nerve Anatomy 0.000 claims abstract description 12
- 238000002513 implantation Methods 0.000 description 11
- 238000011269 treatment regimen Methods 0.000 description 8
- 230000009286 beneficial effect Effects 0.000 description 7
- 208000014674 injury Diseases 0.000 description 7
- 230000008733 trauma Effects 0.000 description 7
- 238000004891 communication Methods 0.000 description 6
- 239000011295 pitch Substances 0.000 description 6
- 230000036541 health Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 239000011800 void material Substances 0.000 description 4
- 230000008878 coupling Effects 0.000 description 3
- 238000010168 coupling process Methods 0.000 description 3
- 238000005859 coupling reaction Methods 0.000 description 3
- 230000001627 detrimental effect Effects 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000000295 complement effect Effects 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 239000011810 insulating material Substances 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000004936 stimulating effect Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000005684 electric field Effects 0.000 description 1
- 230000005674 electromagnetic induction Effects 0.000 description 1
- 238000005265 energy consumption Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 230000001537 neural effect Effects 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/36071—Pain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/36125—Details of circuitry or electric components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
- A61N1/3754—Feedthroughs
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Electrotherapy Devices (AREA)
Abstract
The present disclosure relates to an electrode lead and 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 the 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 circumferential direction of the electrode lead. According to the electrode lead provided by the disclosure, in the same electrode contact group, the orientations of different electrode contacts are different, and thus the coverage range of stimulation signals generated by different electrode contacts is also different. Compared with the traditional electrode lead with annular electrode contacts, in the electrode lead provided by the disclosure, the coverage area of the single electrode contact in each electrode contact set is smaller, so that other parts of spinal nerves can not be or are less stimulated while a target is accurately covered, and further 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 electrode lead.
Background
With the continued advancement of medical technology, treatments employing implantable neurostimulation systems are becoming more and more common. As an implantable neural stimulation system, a spinal cord stimulation (Spinal Cord Stimulation, SCS) system is applied as a means of pain relief for patients. Conventional spinal cord stimulation systems typically include a control device (e.g., including a pulse generator and battery, etc.) and electrode leads. In operation, the plurality of electrode contacts of the electrode lead deliver electrical pulses generated by the control device to spinal nerves of the patient to relieve pain of the patient.
Conventional spinal cord stimulation systems typically employ electrode contacts that are annular in shape. The stimulating signals generated by the electrode contacts have omnidirectionality and cover a wider range. Thus, the stimulation signals generated by such electrode contacts, in addition to the target, inevitably cover the undesired stimulated sites of spinal nerves, which can negatively impact the health of the patient, and even induce other diseases. In addition, such electrode contacts are typically more energy consuming due to the larger coverage of the generated stimulation signals. Particularly for certain spinal cord stimulation systems that require the control device to be implanted in the patient, higher energy consumption means that the battery and thus the control device are larger, which can increase patient trauma and increase surgical difficulty during delivery.
Disclosure of Invention
In view of the above, the present disclosure provides an electrode lead capable of more precisely covering a target 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 electrode lead provided by the present disclosure includes 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 cord stimulation system to spinal nerves of the patient. The plurality of electrode contact groups are distributed at intervals along the length direction of the electrode lead. Each electrode contact set includes a plurality of electrode contacts distributed at intervals along the circumferential direction of the electrode lead.
According to the electrode lead provided by the disclosure, in the same electrode contact group, the orientations of different electrode contacts are different, and thus the coverage range of stimulation signals generated by different electrodes is also different. Compared with the annular electrode contacts in the traditional electrode lead, in the electrode lead provided by the disclosure, the coverage area of the single electrode contact in each electrode contact set is smaller, so that other parts of spinal nerves can not or less be stimulated while a target spot is accurately covered, 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 coverage of the individual electrode contacts is smaller and thus the power consumption is smaller compared to conventional ring electrode contacts, which makes it possible to reduce the size of the battery and thus the control device. It can be seen that, for spinal cord stimulation systems requiring the implantation of a control device into a patient, the use of the electrode lead provided by the present disclosure is beneficial for reducing trauma to the patient and reducing surgical difficulty during the implantation process.
With reference to the first aspect, in one possible implementation manner, the plurality of electrode contacts of each electrode contact set and the plurality of electrode contacts of the adjacent electrode contact set are distributed alternately in the circumferential direction of the electrode lead. That is, the plurality of electrodes of each electrode contact group are respectively opposed to the gaps between the plurality of electrodes of the electrode contact group adjacent thereto. Alternatively, the gaps between the plurality of electrodes of each electrode contact set and the plurality of electrodes of their respective adjacent electrode contact sets 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, the adjacent electrode contact sets do not cause the portions of the electrode leads to which the electrode contact sets are attached to become excessively stiff even with smaller pitches in the length direction of the electrode leads. 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 group is attached is not excessively stiff. The closer the distance between the adjacent electrode contact sets is, the more comprehensive and dense the whole covered area formed by the plurality of electrode contact sets is, which is beneficial to more comprehensively covering more target targets. 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 void in each electrode contact set may be covered by the electrode contact of the adjacent electrode contact set that is opposite to the void. 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 the reduction of the cost of a single contact 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 set define a first pitch t 1 in a circumferential direction of the electrode lead, any two adjacent electrode contact sets define a second pitch t 2 in a length direction of the electrode lead, and each electrode contact defines a width w in the circumferential direction of the electrode lead and a length h in the length direction of the electrode lead.
This staggered distribution between adjacent electrode contact sets allows a relatively small distance between them, i.e. allows a small ratio of the second distance t 2 between them to the length h of the electrode contact, which ratio may for example have a value in the range of 0.4 to 1.2, preferably in the range of 0.4 to 0.8. Furthermore, this staggered distribution complements the coverage between adjacent electrode contact sets, allowing each electrode contact to have a smaller width, i.e. allowing a relatively larger ratio between the first spacing t 1 between adjacent electrode contacts in the same electrode contact set and the width w of each electrode contact, which may for example have a value in the range of 0.6 to 1.4, more preferably 0.8 to 1.2. The electrode lead with the structure has the advantages of comprehensive covered target points, dense covered areas and excellent flexibility.
The present disclosure is not particularly limited as to the number of electrode contacts included in each electrode contact group. In one possible implementation, the number of the plurality of electrode contacts of each electrode contact set is two. In a particular implementation, the number of the plurality of electrode contacts of each electrode contact set is preferably three. If each electrode contact set contains only two electrode contacts, in order to ensure that the whole of the range covered by all the contacts (i.e. the two electrode contacts) in each contact set has proper omnidirectionality, it is necessary that each electrode contact can cover a larger range, which is detrimental to the accuracy of the stimulation signals generated by each electrode contact. If each electrode contact group comprises four or more electrode contacts, the complexity of the electrode leads is greatly increased. In contrast, the number of the electrodes of each electrode contact set is set to be three, so that the accuracy of the stimulation signals generated by each electrode contact can be ensured, and the electrode lead can be ensured to have relatively low complexity.
With reference to the first aspect, in one possible implementation, the electrode lead further includes a body member having an elongated tubular shape and a wire harness extending within the body member, wherein the plurality of electrode contact sets are attached to the body member, the wire harness being configured to transmit 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 wire harness can be arranged in the main body part in a penetrating mode, and the main body part can protect the wire harness.
With reference to the first aspect, in one possible implementation manner, the number of the plurality of electrode contacts of each electrode contact set is n, and the electrode lead further includes a plurality of gating modules respectively corresponding to the plurality of electrode contact sets, and each gating module is configured to selectively communicate 0 to n electrode contacts in its corresponding electrode contact set with the wire harness.
Since each electrode contact set includes a plurality of electrode contacts, the electrode leads include a larger total number of electrode contacts. If each electrode contact corresponds to one of the wires 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 leads. Larger electrode lead diameters are detrimental to implantation of the electrode lead and increase patient trauma. According to the electrode leads provided by the present disclosure, each gating module is configured to selectively communicate from 0 to all of its corresponding electrode contact sets with the wiring harness such that each electrode contact set corresponds to one line in the wiring harness instead of each electrode contact. Thus, 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 first aspect above; and a control device configured to generate an electrical pulse and to be coupled to the electrode lead in a manner capable of delivering 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 accurately cover the target spot and simultaneously can not or less stimulate other parts of spinal nerves, 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. Further, the spinal cord stimulation system provided by the present disclosure is less energy consuming due to the electrode lead provided by the above aspects of the present disclosure, which makes it possible to reduce the size of the battery and thus the control device. Particularly, for the situation that the control device is required to be implanted into a patient, the spinal cord stimulation system provided by the disclosure is beneficial to reducing the trauma to the patient and the operation difficulty in the implantation process.
With reference to the second aspect, in one possible implementation, the spinal cord stimulation system further comprises an external programmer, wherein the external programmer is configured to obtain control instructions entered by an operator and send the control instructions to the control device to program and/or interrogate the control device.
The control device can be programmed and/or interrogated by a physician and/or patient via an external programmer. For example, the physician may program the control device after implantation via an external programmer to set the 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 a plurality of electrode contacts are used to output the electrical pulses. In a later follow-up visit, the physician may query 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 based on patient condition changes. As another example, the patient may query the control device through an external programmer to view the status of the control device (e.g., the amount of charge remaining), or the patient may program the control device through an external programmer under the authority of a physician to appropriately adjust the electrical pulses.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings that are required to be used in the embodiments will be briefly described below.
It is to be understood that the following drawings illustrate only certain embodiments of the present disclosure and are therefore not to be considered limiting of its scope, for the person of ordinary skill in the art may admit to other equally relevant drawings without inventive effort.
It should be understood that the same or similar reference numerals are used throughout the drawings to designate the same or similar elements (components or portions thereof).
It should be understood that the figures are merely schematic and that the dimensions and proportions of the elements (components or portions thereof) in the figures are not necessarily accurate.
Fig. 1 is a schematic structural view of a spinal cord stimulation system according to an embodiment of the present disclosure.
Fig. 2 is a schematic view of the structure of the 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 showing a structure in which an electrode contact group of the electrode lead in fig. 2 is unfolded in the 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 is a cross-sectional view taken along line A-A in fig. 5.
Fig. 7 is a schematic view showing the structure of a gating module of the electrode lead in fig. 2.
Fig. 8 is a schematic structural view showing a connector and a microcircuit module of the electrode lead of fig. 2.
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 showing a structure in which an electrode contact group of the electrode lead in fig. 9 is unfolded 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 showing a structure in which an electrode contact group of the electrode lead in fig. 11 is unfolded 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 drawings in the embodiments of the present disclosure. It will be apparent that the described embodiments are only some, but not all, of the embodiments of the present disclosure.
Fig. 1 is a schematic diagram of a spinal cord stimulation system 100 according to an embodiment of the present disclosure. Note that, in fig. 1, reference numeral SC is used to indicate the spinal cord of the patient.
As shown in fig. 1, the spinal cord stimulation device 100 includes a control device 10 and an electrode lead 20. The control device 10 is configured to generate an electrical pulse. In this disclosure, the electric pulse may refer to a current pulse or a voltage pulse. The control device 10 is also configured to be coupled to the electrode lead 20 in a manner that enables delivery of electrical pulses to the electrode lead 20. As one 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 sets 21. The plurality of electrode contact sets 21 are configured to deliver electrical pulses generated by the control device 10 to spinal nerves of a patient.
Fig. 2 is a schematic structural view 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 view showing a structure in which the electrode contact group 21 is spread in the circumferential direction of the electrode lead 20, which most clearly shows the distribution of the plurality of contact groups 21 and the plurality of electrode contacts contained therein. Note that, in fig. 2 and 3, and in other figures of the present disclosure, arrow L may be used to indicate the length direction of the electrode lead 20, and arrow C may be used to indicate the circumferential direction of the electrode lead.
As shown in fig. 2 and 3, a 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 distributed at intervals along the circumferential direction of the electrode lead 20.
It should be noted that, although in the embodiment shown in fig. 1 to 4, only four electrode contact sets 21 are shown, 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 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, in the same electrode contact set 21, the orientations of the different electrode contacts 211,212,213 are different, and thus the coverage of the stimulation signals generated by the different electrode contacts 211,212,213 are also different. Compared with the traditional electrode lead with the annular electrode contacts, in the electrode lead 20 provided by the disclosure, the coverage range of the single electrode contact is smaller and has more accurate orientation, so that other parts of spinal nerves can not or less stimulate while the target point is accurately covered, and further accurate directional stimulation can be realized. Therefore, the electrode lead 20 provided by the present disclosure can reduce the side effects caused by excessive stimulation, and is more beneficial to the health of patients. Further, 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 the use of the electrode lead 20 provided by the present disclosure is advantageous in reducing trauma to the patient and reducing surgical difficulty during implantation for situations where it is desirable to implant the control device 10 into the patient.
In addition, due to the adoption of the electrode lead 20, the spinal cord stimulation system 100 provided by the disclosure can accurately cover the target spot without or less stimulating other parts of spinal nerves, and further can realize accurate directional stimulation. Thus, the spinal cord stimulation system 100 provided by the present disclosure can reduce the side effects of excessive stimulation, which is more beneficial to the health of the patient. Further, the spinal cord stimulation system 100 provided by the present disclosure is less energy consuming due to the use of the electrode lead 20, which makes it possible to reduce the size of the battery and thus the control device 10. Particularly in situations where it is desirable to implant the control device 10 into a patient, the spinal cord stimulation system 100 provided by the present disclosure advantageously reduces trauma to the patient and reduces surgical difficulty during the implantation procedure.
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 wire harness 23 may extend in the body member 22. A plurality of electrode contact sets 21 are attached to the body member 22. The wire harness 23 is configured to transmit the electric pulse 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 between the various electrode contacts. In the electrode lead 20 provided in the present disclosure, a plurality of electrode contact sets 21 are attached to a body member 22, and the body member 22 can position and support these electrode contact sets 21. In addition, the wire harness 23 may be threaded into the body member 22, and the body member 22 may protect the wire harness 23.
Fig. 6 is a cross-sectional view taken along line A-A in fig. 5. Referring to fig. 5 and 6, the electrode lead 20 further includes a plurality of gating modules 24, and the plurality of gating modules 24 correspond to the plurality of electrode contact groups 21, respectively. Each gating module 24 is electrically connected to both the wire harness 23 and the plurality of electrode contacts of its corresponding electrode contact set 21. Each gating module 24 is configured to selectively communicate between 0 and all of its corresponding electrode contacts in the 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 coordinated to disconnect all of the n electrode contacts from the wire harness 24 or to connect 1 to n electrode contacts to the wire harness 23.
Since each electrode contact group 21 includes a plurality of electrode contacts, the electrode leads 20 include a larger total number of electrode contacts. If each electrode contact corresponds to one of the wires in the wire harness, the complexity of the wire harness is increased and the diameter of the wire harness 23 and thus the diameter of the electrode lead 20 is increased. Larger diameter electrode leads 20 may not facilitate implantation of the electrode leads 20, increasing trauma to the patient. According to the electrode leads 20 provided by the present disclosure, each gating module 24 is configured to selectively communicate from 0 to all of the electrode contacts of its corresponding electrode contact set 21 with the wire harness 23, such that each electrode contact set 21 corresponds to one line in the wire harness 23 instead of each electrode contact. Thus, 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 diameter of 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 is electrically connected to the wire harness 24 through a wire harness pad P4. The specific implementation of the gate circuit 241 is not specifically limited at this time, as long as it is possible to 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 the trailing end of the electrode lead 20, and the plurality of electrode contact sets 21 may be located at the 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, the microcircuit module 26 includes a communication module 261, a distribution module 262, a connector pad P5, and a harness pad P6. The communication module 261 is electrically connected with the connector 25 through the connector pad P5. The distribution module 262 is electrically connected to the wire harness 23 through the harness pad 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 a portion of the plurality of electrode contact sets 21.
In this embodiment, the electrode lead 20 is connected to the control device 10 through a connector 25 to allow the electric pulse 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 electrical pulses to the electrode lead 20 wirelessly. In this implementation, the electrode lead 20 may have no connector 25 and microcircuit module 26, but rather have a coupling portion capable of wireless coupling with the control device 10.
Referring back to fig. 1, the spinal cord stimulation system 100 also includes one or more external programmers 30. One or more external programmers 30 are communicatively coupled to the control device 10 by wired or wireless means (e.g., bluetooth). The one or more external programmers 30 are configured for an operator (doctor or patient) to input control instructions and send control instructions to the control device 10 to program and/or interrogate the control device 10. In some examples, the spinal cord stimulation system 100 may include an external programmer 30a and an external programmer 30b. External programmer 30a may be used by a physician, and has a high control authority, which may be referred to as a physician programmer. External programmer 30b may be used by a patient with lower control authority, which may be referred to as a patient programmer.
The physician and/or patient can program and/or interrogate the control device 10 via one or more external programmers 30. For example, the physician may program the control device 10 via the physician programmer 30a after implantation of the electrode leads to set the 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 21 are used to output the electrical pulses. At a later follow-up visit, the 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 based on patient condition changes. As another example, the patient may query the control device 10 through the patient programmer 30b to view the status (e.g., amount of charge remaining) of the control device 10, or the patient may program the control device 10 through the patient programmer 30b under the authority of a physician to appropriately adjust the electrical impulses.
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 control of the processor 11. The communication module 13 may be configured to communicate with one or more external programmers 30 and the electrode leads 20 under the control of the processor 11.
With continued reference to fig. 1, the electrode lead 20 is at least partially implanted (at least the portion provided with the plurality of electrode contact sets 21) into the epidural space of the spinal cord of the patient to apply electrical stimulation to spinal nerves of the patient. In one example, both the control device 10 and the electrode lead 20 are implanted within the patient. In another example, only the electrode lead 20 is implanted in the patient and the control device 10 is placed outside the patient, the control device 10 delivering electrical pulses to the electrode lead 20 in a wireless manner, e.g., 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 showing a structure in which the electrode contact group 21 of the electrode lead 20 in fig. 9 is unfolded in the circumferential direction of the electrode lead 20. This embodiment provides an electrode lead 20 that is substantially identical to 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 related descriptions are 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 gaps between the plurality of electrode contacts 211,212,213 of the electrode contact group 21 adjacent thereto, respectively. Alternatively, the plurality of electrodes 211,212,213 of each electrode contact set 21 are substantially collinear with the gaps between the plurality of electrodes 211,212,213 of their adjacent electrode contact sets 21, respectively, in the longitudinal direction 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 other words, the electrode contact 211a is substantially collinear with the gap between the pair of electrode contacts 211b,212b along the length of the electrode lead 20. Similarly, electrode contact 213b is opposite the gap between the pair of electrode contacts 212a,213a, or, in other words, electrode contact 213b is substantially collinear with the gap between the pair of electrode contacts 212a,213a in the length direction of electrode lead 20.
This configuration has a number of advantages. On the one hand, with this configuration, the adjacent electrode contact sets 21 do not cause the portion of the electrode lead 20 to which the electrode contact sets 21 are attached to become excessively stiff even with a smaller pitch in the length direction of the electrode lead 20. If the portion of the electrode lead 20 to which the electrode contact set 21 is attached is excessively stiff, implantation of the electrode lead 20 is not facilitated. That is, with this configuration, it is possible to significantly reduce the distance between adjacent electrode contact groups 21, while ensuring that the portion of the electrode lead 20 to which the electrode contact group 21 is attached is not excessively stiff. The closer the distance between adjacent electrode contact sets 21, the more comprehensive and dense the overall covered area of the plurality of electrode contact sets 21, which is advantageous for more comprehensive coverage of more target targets. On the other hand, according to this 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 void in each electrode contact set 1 may be covered by the electrode contact of the adjacent electrode contact set 21 opposite to the void. 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 the reduction of 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 adjacent two electrode contacts of each electrode contact 21 define a first pitch t 1 in the circumferential direction of the electrode lead 20, any adjacent two electrode contact sets 21 define a second pitch t 2 in the length direction of the electrode lead 20, 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 electrode contact sets 21 allows a relatively small distance between them, i.e. allows a small ratio of the second distance t 2 between them to the length h of the electrode contact, which ratio can for example have a value in the range of 0.4 to 1.2, preferably in the range of 0.4 to 0.8. Furthermore, this staggered distribution complements the coverage between adjacent electrode contact sets 21, allowing each electrode contact to have a smaller width, i.e. allowing a relatively larger ratio between the first spacing t 1 between adjacent electrode contacts in the same electrode contact set 21 and the width w of each electrode contact, which may for example have a value in the range of 0.6 to 1.4, more preferably 0.8 to 1.2. The electrode lead 20 constructed in this manner was found to cover a relatively comprehensive target site, a relatively dense coverage area, and excellent flexibility.
The present disclosure is not particularly limited as 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 set 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 set 21 contains only two electrode contacts, in order to ensure that the whole of the range covered by all the contacts (i.e. the two electrode contacts) in each contact set 21 has a proper omnidirectionality, it is necessary that each electrode contact can cover a larger range, which is detrimental to 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, the number of electrodes of each electrode contact group 21 is set to three, so that not only the accuracy of the stimulation signal generated by each electrode contact can be ensured, but also the electrode lead 20 can be ensured to have a relatively low complexity.
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 showing a structure in which the electrode contact group 21 of the electrode lead 20 in fig. 11 is unfolded in the circumferential direction of the electrode lead 20. This embodiment provides an electrode lead 20 that is substantially identical to 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 related descriptions are omitted. Referring to fig. 11 and 12, in some embodiments, each electrode contact set 21 may include only two electrode contacts 211,212.
It should be understood that the term "include" and variations thereof as used in this disclosure are intended to be 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 other embodiment.
The specific features (elements) described in the foregoing embodiments may be combined in any suitable manner, and in order to avoid unnecessary repetition, the disclosure does not further 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 separated into separate multiple components and/or parts. The disclosure of "a" or "an" to describe a component or section is not intended to exclude other components or sections.
The foregoing is merely a specific embodiment of the disclosure, but the protection scope of the disclosure is not limited thereto, and any person skilled in the art will recognize that changes and substitutions are within the technical scope of the disclosure. Therefore, the protection scope of the present disclosure shall be subject to the protection scope of the claims.
Claims (5)
1. An electrode lead for a spinal cord stimulation system, wherein 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 spaced apart along a length of the electrode lead, each electrode contact set comprising a plurality of electrode contacts spaced apart along a circumferential direction of the electrode lead,
The plurality of electrode contacts of each electrode contact set are alternately distributed with the plurality of electrode contacts of the adjacent electrode contact set in the circumferential direction of the electrode lead,
Any adjacent two electrode contacts of each electrode contact set define a first interval t 1 in the circumferential direction of the electrode lead, any adjacent two electrode contact sets define a second interval t 2 in the length direction of the electrode lead, each electrode contact defines a width w in the circumferential direction of the electrode lead and defines a length h in the length direction of the electrode lead, wherein the ratio of the first interval t 1 to the width w ranges from 0.6 to 1.4, and the ratio of the second interval t 2 to the length h ranges from 0.4 to 1.2.
2. The electrode lead of claim 1, wherein the ratio of the first pitch t 1 to the width w ranges from 0.8 to 1.2, and the ratio of the second pitch t 2 to the length h ranges from 0.4 to 0.8.
3. The electrode lead of any of claims 1-2, wherein the number of the plurality of electrode contacts of each electrode contact set is two.
4. The electrode lead of any of claims 1-2, wherein the number of the plurality of electrode contacts of each electrode contact set is three.
5. The electrode lead of any of claims 1-2, further comprising a body member having an elongated tubular shape and a wire harness extending within the body member, wherein the plurality of electrode contact sets are attached to the body member, the wire harness configured to transmit the electrical pulse to the plurality of electrode contact sets.
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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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