JP2007209523A - Intra-skull embedded type cerebrum cooling unit - Google Patents

Intra-skull embedded type cerebrum cooling unit Download PDF

Info

Publication number
JP2007209523A
JP2007209523A JP2006032407A JP2006032407A JP2007209523A JP 2007209523 A JP2007209523 A JP 2007209523A JP 2006032407 A JP2006032407 A JP 2006032407A JP 2006032407 A JP2006032407 A JP 2006032407A JP 2007209523 A JP2007209523 A JP 2007209523A
Authority
JP
Japan
Prior art keywords
cooling
heat
skull
heat pipe
cerebral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2006032407A
Other languages
Japanese (ja)
Inventor
Takashi Saito
俊 斉藤
Joji Uchiyama
城司 内山
Michiyasu Suzuki
倫保 鈴木
Masami Fujii
正美 藤井
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yamaguchi University NUC
Original Assignee
Yamaguchi University NUC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yamaguchi University NUC filed Critical Yamaguchi University NUC
Priority to JP2006032407A priority Critical patent/JP2007209523A/en
Priority to PCT/JP2007/051058 priority patent/WO2007091424A1/en
Publication of JP2007209523A publication Critical patent/JP2007209523A/en
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/007—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating
    • A61F2007/0075—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled
    • A61F2007/0076—Heating or cooling appliances for medical or therapeutic treatment of the human body characterised by electric heating using a Peltier element, e.g. near the spot to be heated or cooled remote from the spot to be heated or cooled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/10—Cooling bags, e.g. ice-bags

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To locally cool the brain by embedding a compact unit inside the skull regarding the device for calming partial abnormality of brain waves (heat generation) caused by abnormal excitement of nerve cells of the cerebrum such as epilepsy. <P>SOLUTION: The intra-skull embedded type cerebrum cooling unit is composed of: a metal plate or a linear cooling part to be inserted to the skull; a heat pipe; and a heat radiation part. One end of the heat pipe is connected to the cooling part so that heat can be transmitted and the other end is connected to the radiating part so that heat can be transmitted. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

本発明は、脳の極部的な脳波異常、異常発熱を鎮静化するための大脳冷却装置に関する。   The present invention relates to a cerebral cooling device for sedating abnormal brain waves and abnormal fever of the brain.

中枢神経系疾患として、てんかんがある。これは、何らかの原因で大脳神経細胞が異常興奮（異常放電）を起こし、通常の機能が遮断され、意識の低下、全身性のけいれん、筋緊張の低下、異常感覚など多彩な発作症状をもたらす慢性脳疾患である。大半のてんかん患者は抗てんかん薬により発作の抑制が可能である。しかし、抗てんかん薬で発作抑制の困難な難治性てんかん患者も存在する。こうした患者に対し、治療手段の１つとして異常興奮を起こす部位を切除する外科治療が行われている。しかし、脳の一部を切除すると、何らかの障害を伴うことが多く、更に、病変部が言語領野や運動領野といった脳の重要な働きをしている部分に存在する場合、切除による治療は困難であるから、切除範囲に制限があり全ての症例が適応とはならない。近年てんかん患者において、大脳神経細胞が異常興奮を起こす部位を約２０〜２５℃以下に冷却するとその異常な興奮が抑えられることが報告されている。この現象を利用し、脳を冷却することで発作の抑制を行うことができれば、脳を切除するという侵襲的な治療に代わり、より侵襲の低い治療を提供できる。外科治療が適応できない難治性てんかん患者に対し、脳冷却を行うことによって、ＱＯＬの向上が期待される。そこで、本発明者らは、熱電素子により直接脳表面を冷却する装置の開発を行い、装置の有効性を検討し、特許出願を行っている（特許文献１）。   Epilepsy is a central nervous system disease. Chronic nerve cells cause abnormal excitement (abnormal discharge) for some reason, and normal functions are blocked, causing various seizures such as decreased consciousness, generalized seizures, decreased muscle tone, and abnormal sensations. It is a brain disease. Most patients with epilepsy can control seizures with antiepileptic drugs. However, there are patients with intractable epilepsy who are difficult to control seizures with antiepileptic drugs. For such patients, surgical treatment for excising a site causing abnormal excitement is performed as one of the treatment means. However, when a part of the brain is removed, it often accompanies some kind of disorder, and if the lesion is located in a part that plays an important role in the brain, such as the language area or the motor area, it is difficult to treat by excision. As a result, the range of resection is limited and not all cases are indicated. In recent years, it has been reported that, in epileptic patients, the abnormal excitement can be suppressed by cooling the site where cerebral nerve cells cause abnormal excitement to about 20-25 ° C. or lower. If seizures can be suppressed by using this phenomenon and cooling the brain, a less invasive treatment can be provided instead of the invasive treatment of excising the brain. Improvement of QOL is expected by cooling the brain for patients with intractable epilepsy who cannot be treated with surgery. Therefore, the present inventors have developed a device that directly cools the brain surface with a thermoelectric element, studied the effectiveness of the device, and filed a patent application (Patent Document 1).

しかし、熱電素子は大きな電力を必要とし、その電力を供給する電源を生体内に埋め込むことは容易ではない。そこで、体外より冷却が行える装置が望ましい。また、異常興奮を起こす部位は患者によって異なるため、さまざまな部位に対応できる冷却装置が必要である。
特開２００４−１２９９６４号公報 However, thermoelectric elements require a large amount of power, and it is not easy to embed a power source for supplying the power in the living body. Therefore, an apparatus capable of cooling from outside the body is desirable. Moreover, since the site | part which raise | generates abnormal excitation changes with patients, the cooling device which can respond to various site | parts is required.
JP 2004-129964 A

本発明は、てんかん等の異常脳波を生じる脳機能的疾患における病変部を冷却することにより、この異常脳波を抑制するための頭蓋内埋め込み型の大脳冷却装置であって、熱電素子を生体内に埋め込む場合に比べて、体内で電気を必要とする部品を必要とせず、しかも一段とコンパクトで、患者の行動を束縛することの少ない装置を提供することを目的とする。   The present invention relates to an intracranial cerebral cooling device for suppressing abnormal brain waves by cooling a lesion in a brain functional disease that causes abnormal brain waves such as epilepsy, and a thermoelectric element is placed in a living body. It is an object of the present invention to provide a device that does not require parts that require electricity in the body and is more compact and less restricts the behavior of the patient as compared with the case of implantation.

本発明は、上記目的を達成するため、次の態様よりなる。すなわち、
（１）本発明の第１の態様は、頭蓋内に挿着するための冷却部、ヒートパイプ及び放熱部よりなり、該ヒートパイプの一端は冷却部に、また他端は放熱部にそれぞれ伝熱可能に接続された頭蓋内埋め込み型大脳冷却装置である。 In order to achieve the above object, the present invention comprises the following aspects. That is,
(1) The first aspect of the present invention comprises a cooling part, a heat pipe and a heat radiating part for insertion into the skull, one end of the heat pipe being transmitted to the cooling part and the other end being transmitted to the heat radiating part. It is an intracranial implantable cerebral cooling device connected in a heatable manner.

（２）本発明の第２の態様は、ヒートパイプがウィック型又は自励振動型であることを特徴とする前記第１の態様の項に記載の頭蓋内埋め込み型大脳冷却装置である。   (2) A second aspect of the present invention is the intracranial cerebral cooling device according to the first aspect, wherein the heat pipe is a wick type or a self-excited vibration type.

（３）本発明における第３の態様は、冷却部が金属板又は金属線条であることを特徴とする前記第１の態様の項に記載の頭蓋内埋め込み型大脳冷却装置である。   (3) A third aspect of the present invention is the intracranial cerebral cooling device according to the first aspect, wherein the cooling part is a metal plate or a metal filament.

（４）本発明の第４の態様は、冷却部が、金、銀、白金、ニッケル、ステンレススチール、チタン及びそれらの少なくとも１種を含む合金から選ばれる部材よりなることを特徴とする前記第３の態様の項に記載の頭蓋内埋め込み型大脳冷却装置である。   (4) In the fourth aspect of the present invention, the cooling part is composed of a member selected from gold, silver, platinum, nickel, stainless steel, titanium, and an alloy containing at least one of them. 3. An intracranial implantable cerebral cooling device according to the third aspect.

（５）更に、本発明における第５の態様は、放熱部において、熱電素子による冷却、温度の低い液体による冷却、自然空冷及びファンによる強制空冷よりなる冷却手段のうち、いずれかの手段を用いて冷却されることを特徴とする前記第１の態様の項に記載の頭蓋内埋め込み型大脳冷却装置である。   (5) Further, according to a fifth aspect of the present invention, in the heat radiating portion, any one of cooling means including cooling by a thermoelectric element, cooling by a low temperature liquid, natural air cooling, and forced air cooling by a fan is used. The intracranial implantable cerebral cooling device according to the first aspect, wherein the cerebral cooling device is cooled.

本発明は、てんかん等、大脳神経細胞の異常興奮による部分的な脳波異常、発熱を抑制し、鎮静化させる手段として、該異常部（以下、患部という）を冷却するための装置として、ヒートパイプを用いることにより生体内に存在させる部分に電気による駆動部分を必要とせず、しかもコンパクトで患者の行動を実質的に束縛しない装置である。本発明においては、冷却部の形状を適宜選定することにより、大脳表面から深奥部に至る種々の部位に適用することが可能となる。そのため、てんかん以外、例えばパーキンソン病などの不随意運動疾患、難治性中枢性疼痛など、機能的脳疾患であって、電気刺激による神経機能抑制効果により症状を軽減させる治療法を要する患者に対しても、本装置は治療効果を期待することができるのである。しかも、本装置は電気刺激治療の様に、神経を直接的に刺激しないため、より安全な治療法となり得ると思われる。その他、重症脳損傷に対し、全身の低体温療法が行われているが、合併症の多さが問題となっている。本発明の大脳冷却装置による局所脳冷却は合併症を最小限にし、脳保護可能となる。このように本装置は様々な疾患、外傷に応用できるのである。   The present invention relates to a heat pipe as a device for cooling the abnormal part (hereinafter referred to as an affected part) as means for suppressing and sedating a partial brain wave abnormality due to abnormal excitement of cerebral nerve cells such as epilepsy and fever. This is a device that does not require an electric drive part to be present in the living body and is compact and does not substantially restrain the behavior of the patient. In the present invention, by appropriately selecting the shape of the cooling part, it can be applied to various parts from the cerebral surface to the deep part. Therefore, for patients with functional brain diseases other than epilepsy, such as involuntary movement diseases such as Parkinson's disease, refractory central pain, etc. However, this device can be expected to have a therapeutic effect. Moreover, since this device does not stimulate nerves directly like electrical stimulation treatment, it seems to be a safer treatment method. In addition, systemic hypothermia is being used for severe brain damage, but there are many complications. Local brain cooling by the cerebral cooling device of the present invention minimizes complications and enables brain protection. Thus, this device can be applied to various diseases and trauma.

本発明の頭蓋内埋め込み型大脳冷却装置は、冷却部、ヒートパイプ部及び放熱部よりなる。   The intracranial cerebral cooling device of the present invention includes a cooling unit, a heat pipe unit, and a heat radiating unit.

冷却部は、現に異常脳波を出し、或いは発熱している大脳の部位、すなわち患部を直接冷却するため、該異常部位に接して、又は近接して設置される。患部が脳の表面近傍にあるときは、脳硬膜下腔に患部を覆うように脳表面に平板状の冷却板を設置すればよい。また患部が脳の深奥部にある場合には、線条の冷却体を脳中に差し込めばよい。   The cooling part is placed in contact with or close to the abnormal part in order to directly cool the part of the cerebrum that emits abnormal brain waves or generates heat, that is, the affected part directly. When the affected part is in the vicinity of the surface of the brain, a flat cooling plate may be installed on the surface of the brain so as to cover the affected part in the subdural space. When the affected part is in the deep part of the brain, the cooling body of the line may be inserted into the brain.

これらに用いられる冷却部材は、熱伝導率が大きく、且つ薄いシート状又は線条に加工可能で、しかも人体内に置いた場合有害とならないものでなければならない。かかる目的に適する部材としては、一般に金属が用いられるが、中でも、金、銀、白金、ニッケル、チタン、ステンレススチール等が好適であり、特に金、銀、チタンが好ましい。一般に板状の場合には０．１〜１ｍｍ程度の厚さで十分である。また線条とする場合には、熱の移動量を考慮し、断面積０．２ｍｍ２〜２０ｍｍ２程度、好ましくは、０．８ｍｍ２〜７ｍｍ２程とするのがよい。勿論、線条は円柱状には限定されない。例えば、幅１０ｍｍ、厚さ０．５ｍｍの如き短冊形の場合もあり得る。 The cooling member used for these must have a high thermal conductivity, can be processed into a thin sheet or filament, and should not be harmful when placed in the human body. As a member suitable for this purpose, a metal is generally used. Among them, gold, silver, platinum, nickel, titanium, stainless steel, etc. are preferable, and gold, silver, and titanium are particularly preferable. In general, in the case of a plate shape, a thickness of about 0.1 to 1 mm is sufficient. In the case where a streak is considering the movement amount of heat, the cross-sectional area 0.2 mm 2 to 20 mm 2, preferably about preferably set to 0.8mm 2 ~7mm 2 degree. Of course, the filament is not limited to a cylindrical shape. For example, there may be a strip shape having a width of 10 mm and a thickness of 0.5 mm.

これらの冷却部は、ヒートパイプの一端（蒸発部）に熱伝導性を損ねないように接続されている。接続手段は、一般に半田や銀蝋等による蝋付、ネジ止め、圧接、嵌合などがあり、一般に蝋付が好ましい。   These cooling units are connected to one end (evaporating unit) of the heat pipe so as not to impair the thermal conductivity. The connecting means generally includes soldering, soldering, pressure welding, fitting, etc. with solder or silver wax, and brazing is generally preferable.

ヒートパイプは、通常のウィック型、特に平板型ヒートパイプを用いるのが好ましく、更には自励振動型のヒートパイプが、熱輸送量が大きく好ましい。   The heat pipe is preferably an ordinary wick type, particularly a flat plate type heat pipe, and a self-excited vibration type heat pipe is preferable because of its large heat transport amount.

ヒートパイプの一端（蒸発部側）は頭蓋内に置く冷却部に接続するが、他端（凝縮部側）は頭蓋骨を貫通させ、頭皮下で放熱部に接続する。放熱部は場合によってはヒートパイプの凝縮側外表面自体でもよいが、後述する放熱部部材に接続させるのが好ましい。かかる接続手段は、冷却部側と同様に熱伝導性を損なわない手段を採用すべきである。   One end (evaporation part side) of the heat pipe is connected to a cooling part placed in the skull, while the other end (condensation part side) penetrates the skull and is connected to the heat radiation part under the scalp. In some cases, the heat radiating section may be the outer surface of the heat pipe on the condensing side itself, but it is preferably connected to a heat radiating section member described later. As such a connecting means, a means that does not impair the thermal conductivity should be adopted as in the cooling section side.

ヒートパイプは頭蓋内及び頭蓋硬膜、頭蓋骨等を貫通して頭皮下に設置される放熱部に接続するものであるため、可及的に小径のものが好ましく、直径３〜５ｍｍ程度又は平板状のものにあっては、厚さ２〜３ｍｍ、幅３〜５ｍｍ程度のものが用いられる。また体内の熱を対象とするものであり、２０〜４０℃の間で作動する液体、例えば、塩化プロピル、クロロホルム、四塩化炭素、ヘキサ、メタノールなどが熱媒体として用いられる。またウィックは一般に極細線ウィックなど細いものが用いられる。ヒートパイプの長さは、頭蓋骨を通して内部の冷却部から外部の放熱部に熱を輸送するにたる長さが必要であり、通常頭頂部で頭骨を貫通し、耳のあたりに放熱部を設ける関係から、５０ｍｍ〜３００ｍｍ、一般に１００ｍｍ〜２００ｍｍ程度である。またヒートパイプの中間部分は、人間の頭の形状に合わせて屈曲させてあるか、又はフレキンビリティのある材料で構成される。   The heat pipe penetrates through the skull and through the skull dura, skull, etc. and is connected to the heat radiation part installed under the scalp. Therefore, the heat pipe is preferably as small as possible and has a diameter of about 3 to 5 mm or a flat plate shape. For example, a material having a thickness of 2 to 3 mm and a width of 3 to 5 mm is used. Moreover, it is intended for heat in the body, and a liquid that operates between 20 to 40 ° C., for example, propyl chloride, chloroform, carbon tetrachloride, hexa, methanol, etc. is used as a heat medium. In general, a thin wick such as an extra fine wire wick is used. The length of the heat pipe needs to be long enough to transport heat from the internal cooling part to the external heat radiation part through the skull, and usually the skull penetrates the skull at the top of the head and the heat radiation part is provided around the ear. From about 50 mm to 300 mm, generally about 100 mm to 200 mm. Further, the intermediate portion of the heat pipe is bent according to the shape of the human head or is made of a flexible material.

本発明に好適に使用されるヒートパイプは、例えば株式会社フジクラなどから市販されている。   The heat pipe suitably used in the present invention is commercially available from, for example, Fujikura Co., Ltd.

次に放熱部は、場合によっては、ヒートパイプの凝縮部を拡大して、有効な放熱面積を持たせることも可能であるが、該凝縮部に放熱部として別途放熱板を伝熱可能に接続して放熱面積を十分に確保する態様も好ましい。この場合の放熱板としては熱伝導度の大きい物質例えば金属であって、人体に悪影響をあたえないものが用いられる。すなわち、冷却部と同様、金、銀、白金、ステンレススチール、チタンなどが好適に用いられる。   Next, in some cases, the heat dissipating part can expand the condensing part of the heat pipe to have an effective heat dissipating area, but a separate heat dissipating plate can be connected to the condensing part as a heat dissipating part. Thus, a mode in which a sufficient heat radiation area is ensured is also preferable. In this case, a material having a high thermal conductivity, for example, a metal that does not adversely affect the human body is used as the heat sink. That is, gold, silver, platinum, stainless steel, titanium and the like are preferably used as in the cooling unit.

更に該冷却部は、頭皮を介して、対向する位置に冷却装置を設置して、冷却部の放熱を助長することが好ましい。   Furthermore, it is preferable that the cooling unit promotes heat radiation of the cooling unit by installing a cooling device at a position facing the cooling unit via the scalp.

冷却装置としては、頭皮を介して対向する位置にある冷却部の熱を吸収又は発散させるものであれば、その形態や冷却方式は特に限定されない。例えば、熱電素子を用いペルチェ効果を利用し、冷却部の熱を吸収除去する方法、水等の冷媒を循環する冷却板による方法、フィンを取り付け放熱面積を大きくした冷却板を用いる方法、或いはファンにより風を吹き付ける空冷方法など冷却部、延いてはヒートパイプの凝縮部から放熱する手段が何ら制限されることなく用いられる。患者の行動を制約しないためには熱電素子を用いるとか、頭皮を介する自然放熱による空冷手段を用いるのが好ましい。   As a cooling device, if the heat of the cooling part in the position which opposes via a scalp is absorbed or dissipated, the form and cooling system will not be specifically limited. For example, a method of absorbing and removing the heat of the cooling part using the Peltier effect using a thermoelectric element, a method of using a cooling plate that circulates a coolant such as water, a method of using a cooling plate with fins attached to increase the heat radiation area, or a fan The cooling means such as an air cooling method that blows air by means of, and thus means for radiating heat from the condensing part of the heat pipe are used without any limitation. In order not to restrict the behavior of the patient, it is preferable to use a thermoelectric element or air cooling means by natural heat radiation through the scalp.

熱電素子としては、例えば株式会社フェローテック社からミニチュアサーモモジュールとして市販されているものなどが好適に採用し得る。   As a thermoelectric element, what is marketed as a miniature thermo module from Ferrotec Co., Ltd. etc. can be employ | adopted suitably, for example.

本発明の大脳冷却装置を頭蓋内に設置する方法は、先ず頭皮及び筋層を剥離し、頭蓋骨を脳波の異常を来たす部位に合わせてドリル等で切除して開頭する。次に頭蓋骨の下の脳硬膜を切開し、脳硬膜下腔に大脳を露出させ、患部を覆うように大脳表面に冷却部を設置し、その上に脳硬膜を被せ、ヒートパイプの中間部分で脳硬膜を貫通させて縫合し、更に頭蓋骨を同様に覆い、金属等で固定した後、頭皮を縫合する。かくして、ヒートパイプの中間部分から凝縮部は頭蓋骨外で頭皮下に位置させる。   In the method of installing the cerebral cooling device of the present invention in the cranium, first, the scalp and the muscle layer are peeled off, and the skull is excised with a drill or the like in accordance with a site causing an abnormality of the electroencephalogram. Next, an incision is made in the cerebral dura under the skull, the cerebrum is exposed in the subdural space, a cooling part is placed on the surface of the cerebrum so as to cover the affected area, and a cerebral dura is placed on the cerebral dura. The cerebral dura is passed through the middle part and sutured. Further, the skull is similarly covered, fixed with metal or the like, and then the scalp is sutured. Thus, the condensing part from the middle part of the heat pipe is located under the skull and under the scalp.

このようにして、設置した大脳冷却装置は、放熱部から頭皮を通して熱を放出することにより、ヒートパイプを介して大脳患部を冷却することができる。特に放熱部に頭皮を介して対向する位置に冷却装置を設けることにより、てんかん等の異常脳波を発したとき、熱電素子に通電したり、ファンを駆動したり、或いは冷水を循環するなどして、患部を急速に冷却することができる。かくして、患部を２０〜３０℃程度に冷却することにより異常脳波が沈静化に向かうのである。   Thus, the installed cerebral cooling device can cool the cerebral affected part via the heat pipe by releasing heat from the heat radiating part through the scalp. In particular, by providing a cooling device at a position facing the heat radiation part through the scalp, when abnormal brain waves such as epilepsy are generated, the thermoelectric element is energized, the fan is driven, or cold water is circulated. The affected area can be cooled rapidly. Thus, by cooling the affected area to about 20 to 30 ° C., the abnormal brain wave tends to calm down.

以下、図面を用いて説明する。   Hereinafter, it demonstrates using drawing.

図１は、本発明の頭蓋内埋め込み型大脳冷却装置の概念図である。図中１は冷却部であり、一般に金属板又は線条である。この部分は頭蓋内に埋め込まれる部分である。２はヒートパイプであり、頭蓋内に埋め込まれた冷却板からの熱を外部に輸送するヒートパイプは、冷却板の位置から、頭蓋骨外に導くため適宜屈曲させたヒートパイプよりなる。３は放熱部であり、放熱面積を十分に確保するため、一般に金属の平板である（頭蓋骨に添う形状）。好ましくは、放熱部に対向する位置に３−１に示す如き熱電素子や３−２に示すファン等の冷却装置が採用される。これらの電気駆動装置を用いる場合には、当然電源装置が必要となり、小型のバッテリー等を併設するか図示しない。   FIG. 1 is a conceptual diagram of an intracranial cerebral cooling device according to the present invention. In the figure, reference numeral 1 denotes a cooling unit, which is generally a metal plate or a filament. This part is a part embedded in the skull. Reference numeral 2 denotes a heat pipe. A heat pipe that transports heat from a cooling plate embedded in the cranium to the outside is a heat pipe that is appropriately bent from the position of the cooling plate to guide it outside the skull. Reference numeral 3 denotes a heat radiating portion, which is generally a metal flat plate (a shape conforming to the skull) in order to ensure a sufficient heat radiating area. Preferably, a cooling device such as a thermoelectric element as shown in 3-1 or a fan as shown in 3-2 is employed at a position facing the heat radiating portion. When these electric drive devices are used, a power supply device is naturally required, and a small battery or the like is not provided or not shown.

図２は放熱部に対抗させる冷却装置の例を示す概念図である。Ａは熱電素子。４は通電によりペルチェ効果で４−１側は冷却されるが、４−２側は反対に温度が上昇する。そこで４−３の如き蛇管を付設し、冷却水を流す態様である。Ｂは熱電素子４の高温側４−２をファン４−４で冷却する態様である。Ｃは、同様に熱電素子４の高温側４−２にヒートシンクを介してフィン４−５を付設する態様である。更にＤは放熱部として蛇管を用い液体冷媒（通常水）を流通させ熱を除去する態様を示す図である。   FIG. 2 is a conceptual diagram showing an example of a cooling device that opposes the heat radiating section. A is a thermoelectric element. 4 is cooled by the Peltier effect by energization, while the 4-1 side is cooled, but the temperature on the 4-2 side is increased. Accordingly, a serpentine tube as shown in 4-3 is attached to flow cooling water. B is a mode in which the high temperature side 4-2 of the thermoelectric element 4 is cooled by the fan 4-4. Similarly, C is a mode in which fins 4-5 are attached to the high temperature side 4-2 of the thermoelectric element 4 via a heat sink. Furthermore, D is a figure which shows the aspect which distribute | circulates a liquid refrigerant | coolant (normal water) using a serpentine pipe as a thermal radiation part, and removes heat.

図３は、本発明の頭蓋内埋め込み型大脳冷却装置を頭蓋内に設置したときの概念図である。   FIG. 3 is a conceptual diagram when the intracranial cerebral cooling device of the present invention is installed in the cranium.

患者の頭蓋内に冷却部１を埋め込み、ヒートパイプ２は、５の位置で、硬膜、及び頭蓋骨を貫通して頭蓋骨と頭皮との間を通り、耳の後など適当な部位で放熱部３に接続する。頭蓋内ではＢ−１（冷却板の場合）、Ｂ−２（線条の場合）に示すように冷却部が大脳の患部に接して設けられている。   The cooling part 1 is embedded in the patient's skull, and the heat pipe 2 passes through the dura mater and the skull through the skull and the scalp at the position 5, and the heat radiation part 3 at an appropriate part such as behind the ear. Connect to. In the skull, as shown in B-1 (in the case of a cooling plate) and B-2 (in the case of a filament), a cooling part is provided in contact with the affected part of the cerebrum.

かくして、異常脳波が生じた場合等は、極めて効率よく極部を冷却することができるのである。   Thus, when an abnormal electroencephalogram occurs, the pole can be cooled extremely efficiently.

以下に実施例を示す。   Examples are shown below.

本冷却手法の有効性を検討するために動物実験を行った。   An animal experiment was conducted to examine the effectiveness of this cooling technique.

実験には体重４８０〜５５０ｇのＳＤ（Ｓｐｒａｇｕｅ‐Ｄａｗｌｅｙ）ラットの雄５匹を用いた。ラットを麻酔下（７０％ Ｏ２，３０％ Ｎ２Ｏ，４％ ｈａｌｏｔｈａｎｅ）に置き、十分に眠らせた後、気管内挿管を行い、人工呼吸管理下に置いた。次にラットをＮＡＲＩＳＩＧＥ社製ラット頭部３点固定器に固定した。保温マット上にラットを置き、体温を３７℃にコントロールした。ラットの全身状態のモニターとして、血圧、動脈血液ガス分析、直腸温を用いた。この結果により、呼吸条件、ｈａｌｏｔｈａｎｅの濃度などを調節し、血圧を８０〜１００ｍｍＨｇにコントロールした。筋弛緩薬（臭化パンクロニウム）を１ｍｌ静脈内投与し、非動化を行った。局所麻酔薬（リドカイン１％）を皮下に適量注射後、頭頂から側頭部の皮膚を２０ｍｍ×２０ｍｍ切開し、側頭筋を十分に剥離した後、歯科用ドリルを用いて１０ｍｍ×９ｍｍの開頭を行った。開頭範囲はＣｏｒｏｎａｌ ｓｕｔｕｒｅから前２ｍｍ、後８ｍｍである。（図４）開頭操作中は硬膜を損傷しないよう十分注意し、また適宜、冷たい生理食塩水を用いて脳の熱損傷を防いだ。ラットの頭蓋骨は非常に薄く、ヒートパイプの埋め込みは困難であるので硬膜上にヒートパイプ及び、熱電対温度センサを設置した。てんかん誘発物質としてカイニン酸（Ｃ１０Ｈ１５ＮＯ４）を用いた。カイニン酸は神経細胞に作用し、強力な神経細胞興奮をもたらす。これを０．０１ｍｏｌ／ｌリン酸緩衝食塩水ＰＢＳ ｐＨ７．２に溶解し、３ｍｇ／ｍｌに調整した。この溶液１μｌをマイクロダイアリシスプローブにて脳表より２ｍｍ深部に注入した。図４に示すようにカイニン酸注入点は、冷却される部分である。注入にはマイクロシリンジポンプを用い、１０分かけて行った。注入液の流出を防ぐため、プローブは除去せず、留置したままとした。カイニン酸の濃度に関しては、あらかじめ色々と濃度を変えて確かめた結果、この濃度が最も安定して異常興奮がもたらされる最小濃度であった。その他の装置はラット外に設置した。   In the experiment, five male SD (Sprague-Dawley) rats weighing 480 to 550 g were used. Rats were placed under anesthesia (70% O2, 30% N2O, 4% halothane) and allowed to sleep well, followed by endotracheal intubation and placed under artificial respiration control. Next, the rat was fixed to a rat head three-point fixator manufactured by NARISIGE. Rats were placed on a warming mat and body temperature was controlled at 37 ° C. Blood pressure, arterial blood gas analysis, and rectal temperature were used as a monitor of the general condition of rats. Based on this result, the respiratory conditions, the concentration of halothane, etc. were adjusted, and the blood pressure was controlled to 80-100 mmHg. Immobilization was performed by intravenously administering 1 ml of a muscle relaxant (pancuronium bromide). After an appropriate amount of a local anesthetic (lidocaine 1%) was injected subcutaneously, a 20 mm × 20 mm incision was made from the top of the head to the temporal skin, and the temporal muscle was sufficiently peeled off, followed by a 10 mm × 9 mm craniotomy using a dental drill. Went. The craniotomy range is 2 mm front and 8 mm rear from the coronal structure. (FIG. 4) During the craniotomy operation, sufficient care was taken not to damage the dura mater, and cold physiological saline was used as appropriate to prevent heat damage to the brain. Since the rat skull is very thin and it is difficult to embed a heat pipe, a heat pipe and a thermocouple temperature sensor were placed on the dura mater. Kainic acid (C10H15NO4) was used as an epilepsy inducing substance. Kainic acid acts on nerve cells, resulting in strong nerve cell excitement. This was dissolved in 0.01 mol / l phosphate buffered saline PBS pH 7.2 and adjusted to 3 mg / ml. 1 μl of this solution was injected 2 mm deep from the brain surface with a microdialysis probe. As shown in FIG. 4, the kainic acid injection point is a portion to be cooled. The injection was performed using a micro syringe pump over 10 minutes. In order to prevent the injection solution from flowing out, the probe was not removed but left in place. As for the concentration of kainic acid, it was confirmed by changing the concentration in advance that it was the minimum concentration at which this concentration was most stable and caused abnormal excitation. Other devices were placed outside the rat.

脳波計はユニークメディカル社製デジタル脳波計を用い、脳波電極は針型のものを用いた。脳波電極は脳表より２ｍｍ深部に、基準電極は頭皮下に留置した。脳波計測はカイニン酸注入３０分前より持続的に行った。カイニン酸注入後の異常波形は低振幅が主体であり、時折高振幅の異常波が出現するタイプである。これが持続的に出現することを事前に確認した。したがって、同様の波形が出現した時点を異常興奮の開始と定義し、出現２０分後より冷却実験を開始した。尚、脳波測定はカットオフ周波数６０Ｈｚのローパスフィルタをかけた。   The electroencephalograph was a digital electroencephalograph manufactured by Unique Medical, and the electroencephalogram electrode was a needle type. The electroencephalogram electrode was placed 2 mm deep from the surface of the brain, and the reference electrode was placed under the scalp. The electroencephalogram was continuously measured from 30 minutes before kainic acid injection. The abnormal waveform after kainic acid injection is mainly of a low amplitude, and an abnormal wave with a high amplitude occasionally appears. It was confirmed in advance that this appears continuously. Therefore, the time when a similar waveform appeared was defined as the start of abnormal excitement, and the cooling experiment was started 20 minutes after the appearance. In addition, the electroencephalogram measurement applied a low-pass filter with a cut-off frequency of 60 Hz.

実験装置の概略図を図５に示す。実験装置は冷却装置（熱電素子、ヒートパイプ）、熱電対温度センサ、ポンプ、恒温槽、安定化電源、データ収録用パソコンより構成される。   A schematic diagram of the experimental apparatus is shown in FIG. The experimental equipment consists of a cooling device (thermoelectric element, heat pipe), thermocouple temperature sensor, pump, thermostat, stabilized power supply, and data recording personal computer.

熱電素子に電流１．０Ａを与え冷却を行い、脳表の温度変化（図６））と脳波（図７）を計測した。   The thermoelectric element was cooled by applying a current of 1.0 A, and the brain surface temperature change (FIG. 6) and the electroencephalogram (FIG. 7) were measured.

図中６０秒より冷却を開始し、５分間冷却を行った。２４０秒以降、脳波の振幅が減少していることが分かる。   In the figure, cooling was started from 60 seconds, and cooling was performed for 5 minutes. It can be seen that the amplitude of the electroencephalogram has decreased after 240 seconds.

また、脳表面は１０℃程度まで冷却出来ており、てんかん放電抑制を行う冷却能力を十分有していることが分かる。   Moreover, it can be seen that the brain surface can be cooled to about 10 ° C. and has sufficient cooling ability to suppress epilepsy discharge.

また、冷却前脳波（５〜１０秒）と冷却中脳波（３５０〜３５５）の時間軸を拡大したものを図８に示す。冷却後にはてんかん性の異常放電が抑制されている。よって本装置にて、てんかん異常放電の抑制が可能である。   Moreover, what expanded the time axis | shaft of the brain wave before cooling (5-10 second) and the brain wave during cooling (350-355) is shown in FIG. After cooling, epileptic abnormal discharge is suppressed. Therefore, this apparatus can suppress abnormal discharge of epilepsy.

本発明の大脳冷却装置は、てんかんの発作を抑制するため以外にパーキンソン病などの不随意運動疾患、難治性中枢性疼痛などの機能的脳疾患による症状を軽減させるための治療などに用いられる。   The cerebral cooling device of the present invention is used for treatment for reducing symptoms caused by functional brain diseases such as involuntary movement diseases such as Parkinson's disease and refractory central pain, in addition to suppressing epileptic seizures.

は、本発明の頭蓋内埋め込み型大脳冷却装置の概念図である。These are the conceptual diagrams of the intracranial cerebral cooling device of this invention. は、放熱部を構成する装置の例を示す概念図である。These are the conceptual diagrams which show the example of the apparatus which comprises a thermal radiation part. は、本発明の頭蓋内埋め込み型大脳冷却装置を頭蓋内に設置したときの概念図である。These are the conceptual diagrams when the intracranial implantable cerebral cooling device of the present invention is installed in the cranium. は、ラットを開頭し、冷却装置、脳波電極の設置場所及びカイニン酸注入場所の関係を示す図である。FIG. 3 is a diagram showing a relationship between a cooling device, an electroencephalogram electrode installation location, and a kainic acid injection location when a rat is opened. は、本発明の実施例における装置の概念図である。These are the conceptual diagrams of the apparatus in the Example of this invention. は、本発明を作動させたときの能の冷却状況と時間の関係を示す図である。These are the figures which show the relationship between the cooling state of time and the time when the present invention is operated. は、実験時の脳波の変化と、時間との関係を示す図である。These are the figures which show the relationship between the change of the electroencephalogram at the time of experiment, and time. は、冷却前・後の脳波の状態を表す図である。These are the figures showing the state of the electroencephalogram before and after cooling.

Claims (5)

頭蓋内に挿着するための冷却部、ヒートパイプ及び放熱部よりなり、該ヒートパイプの一端は冷却部に、また他端は放熱部にそれぞれ伝熱可能に接続された頭蓋内埋め込み型大脳冷却装置。   Intracranial embedded cerebral cooling comprising a cooling part, a heat pipe and a heat radiating part for insertion into the skull, one end of the heat pipe being connected to the cooling part and the other end being connected to the heat radiating part. apparatus. ヒートパイプがウイック型又は自励振動型であることを特徴とする請求項１記載の頭蓋内埋め込み型大脳冷却装置。   The intracranial implantable cerebral cooling device according to claim 1, wherein the heat pipe is of a wick type or a self-excited vibration type. 冷却部が金属板又は金属線条であることを特徴とする請求項１記載の頭蓋内埋め込み型大脳冷却装置。   2. The intracranial implantable cerebral cooling device according to claim 1, wherein the cooling unit is a metal plate or a metal filament. 冷却部が、金、銀、白金、ニッケル、ステンレススチール、チタン及びそれらの少なくとも１種を含む合金から選ばれる部材よりなることを特徴とする請求項１記載の頭蓋内埋め込み型大脳冷却装置。   The intracranial implantable cerebral cooling device according to claim 1, wherein the cooling unit is made of a member selected from gold, silver, platinum, nickel, stainless steel, titanium, and an alloy containing at least one of them. 放熱部において、熱電素子による冷却、温度の低い液体による冷却、自然空冷及びファンによる強制空冷よりなる冷却手段のうち、いずれかの手段を用いて冷却されることを特徴とする請求項１記載の頭蓋内埋め込み型大脳冷却装置。   2. The cooling unit according to claim 1, wherein the heat radiating unit is cooled by using any one of cooling means including cooling by a thermoelectric element, cooling by a low temperature liquid, natural air cooling, and forced air cooling by a fan. Intracranial cerebral cooling device.
JP2006032407A 2006-02-09 2006-02-09 Intra-skull embedded type cerebrum cooling unit Pending JP2007209523A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2006032407A JP2007209523A (en) 2006-02-09 2006-02-09 Intra-skull embedded type cerebrum cooling unit
PCT/JP2007/051058 WO2007091424A1 (en) 2006-02-09 2007-01-24 Brain-cooling apparatus to be buried in skull

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2006032407A JP2007209523A (en) 2006-02-09 2006-02-09 Intra-skull embedded type cerebrum cooling unit

Publications (1)

Publication Number Publication Date
JP2007209523A true JP2007209523A (en) 2007-08-23

Family

ID=38345030

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2006032407A Pending JP2007209523A (en) 2006-02-09 2006-02-09 Intra-skull embedded type cerebrum cooling unit

Country Status (2)

Country Link
JP (1) JP2007209523A (en)
WO (1) WO2007091424A1 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011083316A (en) * 2009-10-13 2011-04-28 Yamaguchi Univ Local cooling system
EP2345366A1 (en) 2010-01-19 2011-07-20 Arkray, Inc. Monitoring device and monitoring method
WO2011118802A1 (en) 2010-03-26 2011-09-29 国立大学法人山口大学 Localized cerebrum cooling probe and brain-function mapping device
WO2013122351A1 (en) * 2012-02-15 2013-08-22 경북대학교 산학협력단 Brain cooling device for open-skull surgery patient
WO2013122349A1 (en) * 2012-02-15 2013-08-22 경북대학교 산학협력단 Brain cooling device also having fluid discharge function
KR101310272B1 (en) 2012-02-15 2013-09-23 경북대학교 산학협력단 Brain cooling device used after craniotomy
KR101310273B1 (en) 2012-02-15 2013-09-23 경북대학교 산학협력단 Portable cooling device for brain
US8591562B2 (en) 2008-12-02 2013-11-26 University Of Washington Methods and devices for brain cooling for treatment and prevention of acquired epilepsy
US9522081B2 (en) 2008-12-02 2016-12-20 University Of Washington Methods and devices for brain cooling for treatment and/or prevention of epileptic seizures

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010162189A (en) * 2009-01-16 2010-07-29 Tohoku Univ Implanted cooler for internal organs
FR3075034B1 (en) * 2017-12-18 2020-01-10 Commissariat A L'energie Atomique Et Aux Energies Alternatives IMPLANTABLE PROBE FOR LOCALIZED COOLING DEVICE AND DEVICE INCLUDING SAID PROBE

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02140160A (en) * 1988-11-18 1990-05-29 Sadanori Fujino Heating and cooling treating device
US6338727B1 (en) * 1998-08-13 2002-01-15 Alsius Corporation Indwelling heat exchange catheter and method of using same
JP3843054B2 (en) * 2002-10-11 2006-11-08 株式会社アルモウルド EEG control system using an intracranial implantable cerebral cooling device
JP2004197961A (en) * 2002-12-16 2004-07-15 Terumo Corp Thin heat pipe for regulating living body temperature, and living body temperature regulating device

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10517755B2 (en) 2008-12-02 2019-12-31 University Of Washington Methods and devices for brain cooling for treatment and/or prevention of epileptic seizures
US9522081B2 (en) 2008-12-02 2016-12-20 University Of Washington Methods and devices for brain cooling for treatment and/or prevention of epileptic seizures
US8591562B2 (en) 2008-12-02 2013-11-26 University Of Washington Methods and devices for brain cooling for treatment and prevention of acquired epilepsy
JP2011083316A (en) * 2009-10-13 2011-04-28 Yamaguchi Univ Local cooling system
US8923946B2 (en) 2010-01-19 2014-12-30 Arkray, Inc. Monitoring device and monitoring method
EP2345366A1 (en) 2010-01-19 2011-07-20 Arkray, Inc. Monitoring device and monitoring method
US9357960B2 (en) 2010-01-19 2016-06-07 Arkray, Inc. Monitoring device and monitoring method
WO2011118802A1 (en) 2010-03-26 2011-09-29 国立大学法人山口大学 Localized cerebrum cooling probe and brain-function mapping device
KR101310273B1 (en) 2012-02-15 2013-09-23 경북대학교 산학협력단 Portable cooling device for brain
KR101361344B1 (en) 2012-02-15 2014-02-12 경북대학교 산학협력단 Brain cooling device for craniotomy patient
KR101349666B1 (en) 2012-02-15 2014-01-10 경북대학교 산학협력단 Drainage and brain cooling device for craniotomy patient
KR101310272B1 (en) 2012-02-15 2013-09-23 경북대학교 산학협력단 Brain cooling device used after craniotomy
WO2013122349A1 (en) * 2012-02-15 2013-08-22 경북대학교 산학협력단 Brain cooling device also having fluid discharge function
WO2013122351A1 (en) * 2012-02-15 2013-08-22 경북대학교 산학협력단 Brain cooling device for open-skull surgery patient

Also Published As

Publication number Publication date
WO2007091424A1 (en) 2007-08-16

Similar Documents

Publication Publication Date Title
JP2007209523A (en) Intra-skull embedded type cerebrum cooling unit
US10213334B2 (en) Apparatus and method for modulating sleep
US10874543B2 (en) Devices for vestibular or cranial nerve stimulation
US10517755B2 (en) Methods and devices for brain cooling for treatment and/or prevention of epileptic seizures
JP6366939B2 (en) Device for bilateral caloric vestibular stimulation
JP5072955B2 (en) Method and apparatus for treating neurological diseases by non-invasive, localized brain thermal stimulation
US6090132A (en) Method and apparatus for inducing hypothermia
US6156057A (en) Method for inducing hypothermia
WO2003072186A2 (en) Neurostimulation for affecting sleep disorders
Rothman The therapeutic potential of focal cooling for neocortical epilepsy
CA2918317C (en) Apparatus and method for modulating sleep
Fujii et al. Application of focal cerebral cooling for the treatment of intractable epilepsy
Stuck et al. Lesion formation in radiofrequency surgery of the tongue base
JP2011083315A (en) Local cooling system
JP2011083316A (en) Local cooling system
Lee Long term effect of thalamic deep brain stimulation for pain due to brachial plexus injury
US20230201029A1 (en) Method and apparatuses for manipulating an endocrine body-temperature set-point in humans and warm-blooded animals
Tokiwa et al. The palm-sized cryoprobe system based on refrigerant expansion and boiling and its application to an animal model of epilepsy
Kobayashi et al. Transcranial magnetic stimulation of the oculomotor and abducens nerves: Determining the site of excitation in the cat
WO2002089685A2 (en) System and method for cooling the cortex to treat neocordical seizures
Wrona et al. A proactive risk assessment by utilizing Healthcare Failure Mode and Effect Analysis (HFMEA) for safe implementation for peripheral nerve catheters in pediatric patients
Yeomans et al. Selective control of pain networks in the human brain: effects of deep, shaped magnetic fields in acute and chronic pain
Sharma et al. Subcutaneous and peripheral nerve stimulation for the treatment of Horton's Neuralgia (cluster headaches), and chronic paroxysmal hemicranias