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CN-119055949-B - Implantable electrode for intracranial tumor treatment and electric field treatment device

CN119055949BCN 119055949 BCN119055949 BCN 119055949BCN-119055949-B

Abstract

The invention provides an implantable electrode for intracranial tumor treatment and an electric field treatment device, wherein the implantable electrode for intracranial tumor treatment comprises a flexible electrode, the flexible electrode comprises a flexible basal layer and at least one electrode unit arranged on the flexible basal layer, at least one end of the flexible basal layer is not covered by the electrode unit, and an extension section is formed at the part of the flexible basal layer which is not covered by the electrode unit. The electric field treatment device comprises a control module and the implanted electrode, wherein the control module is electrically connected with the flexible electrode of the implanted electrode to generate an alternating current electric field. The flexible electrode can be attached to the surface of a tumor cavity by means of surface adhesion, and the extension section is arranged to extend out of the tumor cavity to be attached to the surface of brain tissue, so that the flexible electrode can be firmly fixed in a body, the targeting of tumor electric field treatment can be obviously improved, the stability of an electric field in a relevant area can be improved, the compliance of a patient can be improved, adverse reactions can be reduced, and the treatment effect can be integrally improved.

Inventors

  • LIU LIBIAO
  • YUAN YUYU

Assignees

  • 广州迈普再生医学科技股份有限公司

Dates

Publication Date
20260508
Application Date
20240914

Claims (12)

  1. 1. An implantable electrode for intracranial tumor treatment, comprising: A flexible electrode (20), wherein the flexible electrode (20) comprises a flexible substrate layer (21) and at least one electrode unit (22) arranged on the flexible substrate layer (21), at least one end of the flexible substrate layer (21) is not covered by the electrode unit (22), and an extension section (211) is formed at the part of the flexible substrate layer which is not covered by the electrode unit (22); The electrode unit (22) of the flexible electrode (20) is used for being placed in a tumor cavity (R) formed after tumor resection, and the extension section (211) is used for being attached to the surface of brain tissue (102) outside the tumor cavity (R).
  2. 2. The implantable electrode for intracranial tumor treatment according to claim 1, wherein the flexible electrode (20) comprises at least two electrode units (22) arranged on the flexible basal layer (21) at intervals in the length direction of the flexible basal layer (21), and the two electrode units (22) are positioned at non-end parts of the flexible basal layer (21).
  3. 3. The implantable electrode for intracranial tumor treatment according to claim 2, wherein the flexible electrode (20) is bent in a shape of a Chinese character 'ji', at least two electrode units (22) are arranged in the tumor cavity (R) at intervals and are opposite to each other, an alternating electric field is generated between the two electrode units (22), two ends of the flexible basal layer (21) are provided with extension sections (211), and the two extension sections (211) of the flexible basal layer (21) are used for extending out of the tumor cavity (R) along directions opposite to each other and are attached to the surface of brain tissue (102) outside the tumor cavity (R).
  4. 4. The implantable electrode for intracranial tumor treatment according to claim 1, wherein the electrode unit (22) comprises a flexible substrate layer (221), a conductive layer (222) and a packaging layer (223) coating the flexible substrate layer (221) and the conductive layer (222) which are sequentially laminated on the flexible substrate layer (21).
  5. 5. The implantable electrode for intracranial tumor treatment according to claim 4, wherein the material of the flexible substrate layer (21) comprises at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide or polyethylene, the material of the flexible substrate layer (221) comprises at least one of thermoplastic polyurethane or medical silica gel, the material of the conductive layer (222) comprises at least one of carbon nanotube, graphene, polythiophene, polyaniline, polypyrrole, gold, silver, or platinum iridium alloy, and the material of the encapsulation layer (223) comprises at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, and composite high dielectric constant material containing inorganic nanoparticles as a filler.
  6. 6. The implantable electrode for intracranial tumor treatment according to claim 4, wherein the conductive layer (222) is rectangular in shape, or The conductive layer (222) comprises a strip-shaped trunk (2221) and a plurality of branches (2222) which are arranged at intervals, and the branches (2222) which are arranged at intervals are integrally connected with one side of the same trunk (2221).
  7. 7. The implantable electrode for intracranial tumor treatment according to any one of claims 1 to 6, wherein a plurality of through holes (212) penetrating the flexible basal layer (21) are provided on the extension (211) of the flexible electrode (20).
  8. 8. An electric field therapy apparatus, comprising: Control module, and The implantable electrode for intracranial tumor treatment as recited in any one of claims 1 to 7, electrically connected to the control module, for generating an alternating electric field from the implantable electrode; wherein at least two of said implantable electrodes for intracranial tumor treatment or at least two of said electrode units (22) are comprised.
  9. 9. The electric field therapeutic apparatus as set forth in claim 8, wherein the flexible electrode (20) is a first electrode, the control module is electrically connected to the flexible electrode (20), an electrode unit (22) of the flexible electrode (20) is disposed in a tumor cavity (R) formed after tumor resection, and an extension section (211) of the flexible electrode (20) is disposed to extend out of the tumor cavity (R) and attach to a surface of brain tissue (102) outside the tumor cavity (R); The electric field therapy apparatus further comprises at least one second electrode (30), the second electrode (30) also being electrically connected to the control module and for implantation outside the tumor cavity (R), the control module being configured to enable an alternating electric field to be formed between the flexible electrode (20) and the at least one second electrode (30).
  10. 10. An electric field therapy apparatus as claimed in claim 9, wherein said second electrode (30) is for implantation in a position below the skull (105) and above the dura mater.
  11. 11. The electric field therapy apparatus of claim 9, wherein said electric field therapy apparatus has an electric field therapy mode and an impedance measurement mode.
  12. 12. The electric field therapy apparatus of claim 11, wherein: In the electric field therapy mode, the control module delivers alternating current of a frequency to the flexible electrode (20) or to the flexible electrode (20) and the second electrode (30), applies an electric field effect to tumor cells in a targeted area, and/or, In the impedance measurement mode, the control module delivers alternating current of a frequency range to the flexible electrode (20) or to the flexible electrode (20) and the second electrode (30), measuring the impedance value of the targeted area.

Description

Implantable electrode for intracranial tumor treatment and electric field treatment device Technical Field The invention relates to the field of medical equipment, in particular to an implantable electrode for intracranial tumor treatment and an electric field treatment device. Background Gliomas are the most common malignant neoplasms in the cranium, a collective term for neoplasms derived from glial cells and neuronal cells of the nervous system, accounting for 40% to 50% of the total number of lesions in intracranial neoplasms. The median survival time of glioblastoma patients is between 14.6 months and 17 months, and is a malignant disease which seriously affects human health and quality of life. At present, the treatment for glioma is mainly surgical excision, but as the tumor shows diffuse growth, no clear limit exists between the tumor and normal tissues, and in order to protect normal physiological functions, complete excision is difficult in practice. Clinically, the tumor has high postoperative recurrence probability and poor prognosis. Most importantly, there is a barrier to the blood brain barrier in the cranium, and most drugs have difficulty exerting an effect against tumors across the blood brain barrier. Tumor electric field treatment is to act on microtubulin of proliferation cancer cells by using a low-intensity and medium-frequency alternating electric field to interfere with tumor cell mitosis, so that tumor growth is inhibited and the affected cancer cells are subjected to apoptosis. Thus, tumor electric field therapy is gaining widespread attention and acceptance by physicians as a new therapeutic modality. An international phase III multicenter clinical study on newly diagnosed glioblastoma patients showed that tumor electric field therapy in combination with Temozolomide (TMZ) significantly improved Progression Free Survival (PFS) and total survival (OS) in patients compared to Temozolomide (TMZ) chemotherapy alone. The study demonstrated that tumor electric field therapy was used in combination with temozolomide to treat neoglioblastoma, the five-year Overall Survival (OS) of the patient was increased from 5% to 13% and the median overall survival of the patient was prolonged from 16 months to 20.9 months. The effect exhibited by tumor electric field therapy is closely related to compliance, and the survival time in patients with high compliance is significantly prolonged. The key core component electrode in the tumor electric field treatment equipment which is currently applied on the market is external. The main structure of the external device is shown in fig. 1, and when a tumor 103 exists in the brain of a patient, a common treatment method in the prior art is to attach an attached electrode 101 to the scalp 104 of the patient. From clinical results, researches and comprehensive analysis of doctors and patients, the external electrode scheme has the defects that firstly, the heat generation is serious, the phenomena of scalp 104 inflammation, allergy and the like are caused, secondly, the effect is unstable, the electrodes are required to be frequently replaced and reattached in the treatment process, the attachment positions of the electrodes are not strictly consistent each time, the electric field effect applied to a tumor area is different, thirdly, the patient compliance is poor, the hair is required to be shaved, the scalp 104 inflammation, allergy and the like in the wearing process are caused, the time for the patient to wear the device is reduced, and the treatment effect and the wearing time are directly positively correlated, so that the wearing time is reduced, and the treatment effect is influenced. In this regard, the prior art is directed to the study of implanting electrodes into intracranial tumor sites to solve the above-mentioned problems, but the existing implantable electrodes often rely on lead extraction after implantation into a tumor resection cavity, and the lead is fixed to brain tissue or skull by screws, adhesives or sutures outside the tumor cavity. However, this lead fixation method is prone to unstable positions of the electrodes in the tumor resection cavity, thereby affecting the therapeutic effect of the electric field. The fixation with adhesive has biocompatibility, and may cause inflammation, allergy and other chronic adverse reactions, and the fixation with screw, suture and other methods may further cause intracranial damage. Disclosure of Invention The present invention has been made in view of the above-mentioned drawbacks and deficiencies of the prior art. The invention aims to provide an implantable electrode for intracranial tumor treatment, which comprises a flexible electrode, wherein the flexible electrode comprises a flexible basal layer and at least one electrode unit arranged on the flexible basal layer, at least one end of the flexible basal layer is not covered by the electrode unit, and an extension section is formed at the