JP6795975B2 - 鼻刺激デバイス及び方法 - Google Patents
鼻刺激デバイス及び方法 Download PDFInfo
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- JP6795975B2 JP6795975B2 JP2016509141A JP2016509141A JP6795975B2 JP 6795975 B2 JP6795975 B2 JP 6795975B2 JP 2016509141 A JP2016509141 A JP 2016509141A JP 2016509141 A JP2016509141 A JP 2016509141A JP 6795975 B2 JP6795975 B2 JP 6795975B2
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- A61H2205/00—Devices for specific parts of the body
- A61H2205/02—Head
- A61H2205/022—Face
- A61H2205/023—Nose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
- A61H2205/00—Devices for specific parts of the body
- A61H2205/02—Head
- A61H2205/022—Face
- A61H2205/024—Eyes
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N7/00—Ultrasound therapy
- A61N2007/0043—Ultrasound therapy intra-cavitary
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Description
本出願は、2013年8月19日に出願され、「NASAL STIMULATION DEVICES AND METHODS」と題する米国仮特許出願第61/814,166号、及び2013年7月31日に出願され、「NASAL STIMULATION DEVICES AND METHODS」と題する米国仮特許出願第61/860,839号に対する優先権を主張するものであり、これらの両方は、参照によりそれらの全体が本明細書に組み込まれる。
本明細書に記載される刺激システムのいくつかの変形形態は、手持ち式刺激装置を含み得る。図1A、1B、1C、1D、1Eは、それぞれ、手持ち式刺激装置100例証的な変形形態の斜視図、正面図、背面図、切欠背面図、及び切欠側面図をそれぞれ示す。図2は、刺激装置100を概略的に表すブロック図を示す。図1A〜1Eに示される通り、刺激装置100は、刺激装置本体102及び刺激装置プローブ104を含み得る。一般に、刺激装置本体102は、対象に送達され得る刺激を発生させるように構成され得る。刺激装置本体102は、正面筐体138、背面筐体140、及び近位筐体142を含むことができ、それらは共に適合して、本体空洞154を画定し得る。本体空洞154は、制御サブシステム136及び電源152を含有することができ、それらは共に、刺激を発生させ、制御し得る。
上記に簡単に記載される通り、刺激装置本体は、筐体、ユーザインターフェース、制御サブシステム、及び電源を備え得る。
図3A及び図3B〜3Cは、それぞれ、刺激装置本体102の斜視図及び分解図を示す。刺激装置本体102は、任意の好適な形状を有し得る。いくつかの変形形態において、刺激装置本体102は、使用者によって容易に把持され得るように、片手で保持され得るように、表面上に直立して定置され得るように、ならびに/または、ポケットもしくは財布の中に容易に及び/もしくは個々に持ち運ばれ得るように形状付けられることが望ましい場合がある。図3Aに示される通り、刺激装置本体102は、先端を切り取った卵形形状を有し得る。しかしながら、刺激装置本体は他の形状を有し得ることが理解されるべきである。例えば、図4に示される通り、刺激装置本体402は、平坦な近位端部及び丸みを帯びた遠位端部を有してもよい。別の例として、図5に示される通り、刺激装置本体502は、丸みを帯びた角及び先細の近位端部を有した略長方形形状を有してもよい。他の変形形態において、刺激装置本体は、長方形形状、丸みを帯びた長方形形状、円形形状、円筒形形状、三角形形状、涙滴型などを有してもよく、その各々は、先端が切り取られていてもよく、またはそうでなくてもよい。刺激装置本体102の近位端部(近位筐体142によって形成される)は、下記により詳細に記載される通り、刺激装置プローブ104の底部に相補的な形状を有してもよい。
本明細書に記載される刺激装置がユーザインターフェースを備える例では、ユーザインターフェースは、1つ以上の動作機構を備えることができ、それは使用者が刺激装置の1つ以上の機能を制御することを可能にし得る。例えば、動作機構は、使用者が、本デバイスの電源を入れるもしくは切る、刺激を開始もしくは停止する、刺激の強度を変化させる、刺激の間隔を変化させる、刺激パターンを変化させることなどを可能にし得る。いくつかの変形形態において、動作機構は、異なる機能を活性化もしくは非活性化することができ、及び/または、それらの動作の様式(例えば、ボタンを短く押圧すること、ボタンを長時間押圧すること、ボタンを特定のパターンの押圧動作で押圧すること、ダイヤルを異なる角度または異なる速度で回転させること)に基づいて異なるパラメータを変化させることができる。1つ以上の動作機構の各々は、限定されるものではないが、ボタン、スライダ、レバー、タッチパッド、ノブ、または筐体の変形可能/押し潰し可能な部分などの任意の好適な構造であってよく、また刺激装置は、異なる動作機構の任意の組み合わせを備えてもよい。
一般に、制御サブシステムは、刺激装置プローブを介して対象に送達される刺激を制御するように構成され得る。制御サブシステムは、筐体刺激装置の内部に含有され得る。制御サブシステムは、刺激装置の動作機構(例えば、ボタン)に接続されることができ、それは制御サブシステムが使用者から入力を受信することを可能にし得る。制御サブシステムはまた、使用者にフィードバックを提供するか、ないしは別の方法で情報を伝えるように構成される機構に接続されてもよい。刺激装置100などのいくつかの変形形態において、制御サブシステム136は、プリント回路板128上に配置され得る。制御サブシステム136がプリント回路板128上に配置される場合、プリント回路板128は、任意の好適な様式で刺激装置本体102の本体空洞154内部に固定され得る。いくつかの変形形態において、プリント回路板128は、ピン144によって筐体に対して定位置に保持され得る。図3Bに示される通り、背面筐体140の内側表面は、4つのピン144を備え得る。ピン144は、プリント回路板128内の対応する開口156を通して適合するように構成されてもよく、また正面筐体138内の受け凹部238内に適合するようにさらに構成されてもよい。プリント回路板がピンによって固定される他の変形形態では、筐体は、任意の数のピン144を備えることができ、それは筐体の任意の部分上に配置され得ることが理解されるべきである。
刺激装置は、電源を備え得る。電源は、1つ以上の電池、コンデンサ、または同様のものなどの、刺激装置の1つ以上の機能に電力を供給することができる任意の好適な電力供給源であり得る。図3C〜3Dに示される通り、いくつかの変形形態において、電源は、リチウムコイルセル電池152を備え得る。電池152は、制御サブシステム136を備えるプリント回路板128に取り付けられたクリップ160などの、任意の好適な方法を介して定位置に固定され得る。いくつかの変形形態において、電源は、下記により詳細に記載される通り、充電式であり得る。
刺激装置の刺激装置プローブは、1つ以上の鼻挿入プロングを備えることができ、それは、対象の鼻腔内に少なくとも部分的に延在するように構成され得る。図6A、6B、6C、6D、及び図6E〜6Fは、それぞれ、刺激装置100の刺激装置プローブ104の背面図、側面図、切欠背面図、切欠上面図、及び斜視図を描写する。ここに示される通り、刺激装置プローブ104は、第1の鼻挿入プロング106及び第2の鼻挿入プロング108を備え得る。第1及び第2のプロング106及び108は、ベース部材126を介して接続され得る。ベース部材126は、第1及び第2のプロングの少なくとも一部分を、互いに対して固定された関係に保持するように構成され得る。
鼻挿入プロング106及び108は、概して対象の鼻孔に挿入されるように構成され得る。図6A〜6Fに示される通り、各鼻挿入プロング106及び108は、それぞれ、細長い部分162及び164を備え得る。各細長い部分162及び164は、その遠位端部に遠位部分176及び178を有し得る。いくつかの変形形態において、遠位部分176及び178は、遠位部分より近位のプロングの細長い部分162及び164の直径(または最大断面寸法)よりも大きい直径(または最大断面寸法)を有し得る。これは、細長い部分162及び164が対象の組織と接触していないままで、遠位部分176及び/または178の一部分(例えば、下記に記載される電極)が対象の組織と接触することを可能にし得る。例えば、遠位部分176及び178における鼻挿入プロング106及び108の直径は、いくつかの例では、約3mm〜約7mmの間であり得、一方で細長い部分162及び164の直径は、遠位部分より近位で約1mm〜約6mmの間であり得る。より具体的には、いくつかの変形形態では、遠位部分176及び178における鼻挿入プロングの直径は約5mmであり得、細長い部分162及び164の直径は約3mmであり得る。細長い部分162及び164の近位部分は、ベース部材に向かって外側に広がってもよく(すなわち、増加する直径または最大断面寸法を有する)、それは、いくつかの変形形態において、鼻挿入プロング106及び108が使用者の鼻内に前進され得る距離を制限する止め部として機能し得る。
本明細書に記載される刺激装置が電気刺激を送達するように構成される場合、鼻挿入プロングのうちの少なくとも1つは、組織に刺激を送達するように構成される1つ以上の電極を備え得る。刺激装置が2つの鼻挿入プロングを備える変形形態では、2つの鼻挿入プロングの各々は、少なくとも1つの電極を備え得る。複数の電極を有するプロングを有することは、下記により詳細に考察されるであろう通り、刺激装置が双極性刺激(及び/または2つの鼻孔の両側性刺激)を提供することを可能にし得る。
本明細書に記載される刺激装置の鼻挿入プロング(単数)またはプロング(複数)が1つ以上の電極を備える場合、電極は、リード線を備え得る。刺激装置プローブが刺激装置本体に接続されるとき、リード線は、下記により詳細に記載される通り、刺激装置本体の回路と接触して、電極を刺激装置本体回路に電気的に接続させ得る。したがって、リード線は、鼻挿入プロングの各々を通して少なくとも部分的に延在し得る。リード線は、1つ以上の伝導性材料(例えば、ステンレス鋼、チタン、白金もしくは白金−イリジウム、それらの他の合金、または同様のもの)、伝導性セラミック(例えば、窒化チタン)から形成されることができ、各リード線の少なくとも一部分が対応する電極と接触して、リード線と電極との間に伝導路を提供するように位置付けられ得る。
一般に、本明細書に記載される刺激装置プローブが電気刺激を送達するように構成される場合、本明細書に記載される刺激装置プローブのいずれかの外部表面は、電極を除いて絶縁され得る。これは、他の組織の不用意な刺激(例えば、電極の代わりにリード線との直接的な組織接触による)を阻止するのに役立ち得る。したがって、いくつかの変形形態において、プロングは、1つ以上の絶縁材料(例えば、PTFE、シリコーン、それらの組み合わせ、または同様のもの)から形成されるか、またはないしはそれらでコーティングされ得る。例えば、図6A〜6Fに示される刺激装置プローブの変形形態では、第1及び第2のプロングは、可撓性ポリマー(例えば、熱可塑性エラストマー(例えば、熱可塑性エラストマー合金(例えば、Versaflex(商標))、熱可塑性ポリウレタン樹脂、または同様のもの)、シリコーン、または同様のもの)などの絶縁材料から形成されることができ、またリード線は、本明細書に記載される通り、それらが刺激装置プローブの使用中に第1及び第2のプロングの外側表面から電気的に絶縁されるようにプロングの内側に位置付けられ得る。したがって、これらの例では、リード線に提供される電気刺激エネルギーは、電極を介して送達され得る。同様に、刺激装置プローブ900のスリーブ924及び刺激装置プローブ1000のスリーブ1024の材料は、絶縁であり得る。
本明細書の刺激装置との使用のために刺激装置プローブは、任意の好適な設計を有し得る。例えば、図11A〜11Bh、刺激装置プローブ1100の別の変形形態を示す。ここに示される変形形態では、第1の鼻刺激プロング1101及び第2の鼻刺激プロング1103は、シリコーンなどの絶縁材料から形成されることができ、またリード線1118は、それらが刺激装置プローブ1100の使用中に第1の鼻刺激プロング1101及び第2の鼻刺激プロング1103の外側表面から電気的に絶縁されるように鼻刺激プロングの内側に位置付けられ得る。したがって、これらの例では、リード線1118に提供される刺激エネルギーは、電極1108を介して送達され得る。
物理的接続
本明細書に記載される刺激装置プローブ(及びそれらの任意のプロング)は、任意の好適な様式で刺激装置本体に接続され得る。いくつかの変形形態において、刺激装置プローブは、刺激装置本体に直接的に接続するように構成され得る。これらの変形形態では、刺激装置プローブの少なくとも一部分は、2つが接続されるときに、刺激装置本体に対して固定された場所及び配向を有し得る。これらの変形形態のうちのいくつかにおいて、刺激装置プローブは、刺激装置本体に永久的に接続され得る。例えば、刺激装置プローブ及び刺激装置本体は、それらが永久的に接続されるように一緒に形成され得る。他の変形形態では、刺激装置プローブは、刺激装置本体にクリップ留め、ラッチ、スナップ留め、ないしは別の方法で機械的に接続し得る。これらの変形形態のうちのいくつかにおいて、刺激装置プローブは、刺激装置プローブが接続された後に刺激装置本体から切断され得るように、刺激装置本体に解放可能に接続され得る。
一般に、本明細書に記載される刺激装置が電気刺激を送達するように構成される場合、刺激装置の電極は、刺激装置が刺激を発生させて、それを電極のうちの1つ以上を介して組織に送達し得るように、刺激装置回路に電気的に接続され得る。したがって、本明細書に記載される刺激装置は、リード線を介して電極を刺激装置本体の一部分(例えば、刺激装置本体内に格納された刺激サブシステム)に電気的に接続するように構成される1つ以上の電気的接続を備え得る。刺激装置プローブ及び刺激装置本体が間接的に接続される変形形態では、間接的な接続(例えば、ケーブル、コード、または同様のもの)は、刺激装置回路と電極との間の電気的接続として機能し得る。刺激装置プローブ及び刺激装置本体が直接的に接続される変形形態では、刺激装置本体及び刺激装置プローブは、本体及びプローブが接続されたときに刺激装置プローブの電極を刺激装置回路に電気的に接続するように構成される伝導性要素を備え得る。
いくつかの変形形態において、刺激装置のうちのいくつかまたは全部は、使い捨てであり得る。刺激装置本体が刺激装置プローブに永久的に取り付けられる変形形態では、刺激装置全体が使い捨てであり得る。他の変形形態では、刺激装置の1つ以上の部分は、再使用可能であり得る。例えば、刺激装置プローブが刺激装置本体に解放可能に接続される変形形態では、刺激装置本体は、再使用可能であり得、刺激装置プローブは、使い捨てであり得る。したがって、刺激装置プローブは、下記により詳細に記載されるであろう通り、定期的に交換され得る。また他の変形形態では、刺激装置プローブの一部分は、使い捨てであり得(例えば、刺激装置プローブは、使い捨てであるスリーブまたは使い捨てであるプロングを備え得る)、定期的に交換され得る。いくつかの変形形態において、本明細書に記載される刺激装置は、主要な適切な衛生状態のために、特定の期間後または定期的に刺激装置または刺激装置構成要素を交換するように使用者に推奨または要求する特徴を備え得る。
いくつかの変形形態において、本明細書に記載される刺激装置は、刺激装置プローブを保護するためのキャップを備え得る。例えば、図19A及び19Bは、それぞれ、取り付けられたキャップ1900を有する刺激装置100の斜視及び正面図を示す。ここに示される通り、キャップ1900は、刺激装置プローブ104の上に適合することができ、それはプローブを汚染から保護し得る。より具体的には、キャップは、鼻挿入プロングを、また特に電極を汚染から保護することが望ましい場合がある。キャップ1900は、任意の好適な形状を有し得る。いくつかの変形形態において、キャップ1900は、刺激装置に取り付けられたときに動作機構を被覆し得る。これは、動作機構が不用意または偶然に操作されるのを阻止し得る。図19A〜19Bに示される通り、キャップ1900は、刺激装置本体102の側面を曝露させたまま、刺激装置本体102のボタン114及び116を被覆し得る。これは、使用者が、キャップ1900を取り外すために刺激装置本体102をより容易に把持することを可能にし得る。いくつかの変形形態において、キャップは、キャップ1900上に示されるリッジ1904などの、取り外しに役立つ凹凸を有する表面または他の把持特徴を備え得る。キャップまたは他の囲いは、プラスチックまたは合成樹脂などの任意の好適な材料(単数)または材料(複数)を含み得る。いくつかの変形形態において、キャップまたは他の囲いは、半透明または透明であり得るが、他の変形形態では、不透明であってもよい。
いくつかの変形形態において、本明細書に記載される刺激システムは、刺激装置の一部分に接続するように構成されるベースステーションを備えることができ、刺激装置は、刺激装置本体及び刺激装置プローブを有する。ベースステーションは、刺激装置の1つ以上の部分に解放可能に接続するように構成されることができ、刺激装置に接続されたときに、1つ以上の機能を実施するように構成されることができる。図21A〜21Dは、本明細書に記載されるベースステーション2100を備える刺激装置システムの一部分を描写する。図21Aは、ベースステーション2100内に結合された刺激装置本体2102の正面図を示し、図21B、21C、及び21Dは、それぞれ、ベースステーション2100の側面図、背面図、及び上面図を描写する。刺激装置本体2102及び刺激装置プローブ(図示無し)は、本明細書に記載される刺激装置の要素のいずれかを含み得る。刺激装置本体2102が充電式の動力源(充電式電池、コンデンサ、または同様のものなど)を備える変形形態では、ベースステーション2100は、充電式の動力源を充電するように構成され得る。例えば、ベースステーション2100は、1つ以上の電気的接触2104を備えることができ、それは刺激装置本体2102上の対応する電気的接触に電気的に接続するように構成され得る。いくつかの変形形態において、これらの電気的接触は、刺激装置プローブ及び刺激装置本体を接続する同一の電気的接触であり得る(例えば、刺激装置100のコネクタ122及び124に類似の電気的接触)。この電気的接続は、ベースステーション2100が刺激装置本体2102の電源を充電することを可能にし得る。
いくつかの変形形態において、本明細書に記載される刺激装置は、携帯デバイス(例えば、携帯電話、タブレット、ウェアラブルコンピュータ(例えば、Google Glass(商標)などの光学頭部装着型ディスプレイ)、または同様のもの)、コンピュータ、または同様のものなどの外部デバイスに接続するように構成され得る。刺激装置は、任意の好適な接続方法を通して外部デバイスに接続するように構成され得る。いくつかの変形形態において、接続方法は、無線であり得(例えば、WiFi、Bluetooth(登録商標)、または同様のものを介して)、刺激装置は、アンテナまたは同様のものを備え得る。加えてまたは代替として、接続方法は、有線伝送線を介してもよい。これらの変形形態では、刺激装置は、刺激装置を外部デバイスに物理的に接続するように構成される1つ以上のポート(例えば、USBポート)、コネクタ、及び/またはケーブルを備え得る。いくつかの変形形態において、刺激装置は、無線または有線接続を使用してインターネットに接続することができ、それを介して外部デバイスに接続され得る。これらの変形形態では、デバイスは、離れた場所(例えば、製造者、診察室、または同様のもの)にあってもよい。
本明細書に記載される刺激システムのいくつかの変形形態において、刺激システムは、対象内に永久的にかまたは一時的にかのいずれかで埋め込まれるように構成される刺激装置を備え得る。埋め込み式刺激装置は、必ずしも外科的に埋め込まれる必要はないことが理解されるべきである。これらの例のうちのいくつかでは、埋め込み式刺激装置は、刺激装置が使用者によって挿入及び/または取り外されることができるように構成され得る。これらの例のうちの他のものでは、埋め込み式刺激装置は、医療専門家によって挿入及び/または取り外されることができるように構成され得る。他の例では、刺激装置は、鼻腔または副鼻腔内の組織内に埋め込まれるか、ないしは別の方法で取り付けられるように構成され得る。
一般に、本明細書に記載される刺激装置及び刺激システムは、鼻組織または副鼻腔組織を刺激するように構成され得る。いくつかの変形形態において、刺激は、使用者による涙液産生を引き起こすために使用され得る。一般に、刺激装置(上記に記載されるものなど)は、鼻涙腺反射を介して流涙応答を活性化し得る1つ以上の鼻求心性神経または副鼻腔求心性神経を刺激するように構成され得る。いくつかの例では、これは、三叉神経または求心性三叉神経(trigeminal nerve afferent)の1つ以上の枝を刺激することを含み得る。これらの例のうちのいくつかでは、これは、三叉神経の眼枝を刺激することを含み得る。この刺激は、慢性ドライアイ、一過性ドライアイ、季節性ドライアイ、涙液減少型ドライアイ、または蒸発型ドライアイを含む(がこれらに限定されない)、種々の形態のドライアイを治療するために使用され得る。
埋め込み式刺激装置を使用して刺激が提供されるとき、埋め込み式刺激装置は、1つの鼻腔または副鼻腔(または複数の鼻腔または副鼻腔)内に位置付けられ得る。手持ち式刺激装置を使用して刺激が提供されるとき、刺激装置の1つ以上のプロングは、少なくとも部分的に使用者の鼻内に挿入されることができ、刺激信号(上記に記載されるものなど)が粘膜組織に送達され得る。
いくつかの変形形態において、刺激は、片側に(例えば、単一の鼻孔内に)送達され得る。例えば、刺激装置が単一のプロングを備える変形形態では、プロングは、第1の鼻孔内に定置されることができ、刺激は、プロングを介して第1の鼻孔に送達され得る。刺激が電気的であるこれらの変形形態のうちのいくつかにおいて、パッド電極または他の戻り電極は、鼻の外側部分に一時的に張り付けられるか、ないしは別の方法で鼻の外側部分と接触して定置されて、戻り電極として機能し得ることが理解されるべきである。刺激装置が2つ以上のプロングを備えるいくつかの変形形態において、プロングの各々は、第1の鼻孔内に定置されることができ、プロングのうちの一部または全部を使用して、粘膜組織に刺激を送達することができる。刺激装置が2つ以上のプロングを備える他の変形形態では、少なくとも1つのプロングは、第1の鼻孔内に位置付けられることができ、また少なくとも1つのプロングは、第2の鼻孔内に位置付けられ得る。刺激が電気的である変形形態において、第1の鼻孔内のプロングの一部もしくは全部は、第1の鼻孔に片側性電気刺激を送達するために使用されることができ(例えば、第2の鼻孔内のプロングは不活性のままであってよい)、または第2の鼻孔内のプロングの一部もしくは全部は、第2の鼻孔に片側性電気刺激を送達するために使用されることができる。
刺激が電気的であるとき、本明細書に記載される刺激装置によって送達される電気刺激は、特定の治療計画及び/または特定の対象のために特注され得る波形(単数)または波形(複数)を含み得る。波形は、パルス性または連続的であり得る。本明細書に記載される波形は、双極性構成または単極性構成を介して送達され得ることが理解されるべきである。刺激装置が連続波形を送達するように構成されるとき、波形は、正弦波、準正弦波、方形波、のこぎり波/ランプ波、または三角波、それらの先端が切り取られた型(例えば、特定の振幅が到達されたときに波形が停滞する)、または同様のものであり得る。一般に、波形の周波数及びピーク間振幅は一定であり得るが、いくつかの変形形態では、刺激装置は、波形の周波数及び/または振幅を変動させるように構成され得る。この変形形態は、所定の計画に従って生じてもよく、または所与のパラメータ内で無作為に生じるように構成されてもよい。例えば、いくつかの変形形態において、連続波形は、波形のピーク間振幅が(例えば、ビート周波数を有する正弦状関数に従って)経時的に変動するように構成され得る。いくつかの例では、刺激波形の振幅及び/もしくは周波数を経時的に変動させること、または刺激をオンとオフとにパルス状にすること(例えば、1秒オン/1秒オフ、5秒オン/5秒オフ)は、対象の馴化(刺激に対する対象の応答が刺激中に減少する)を低減するのを助け得る。加えてまたは代替として、刺激の開始時に刺激波形の振幅を傾斜付けることは、快適性を増加し得る。
いくつかの変形形態において、1つ以上の化学薬剤は、1つ以上の病態を治療するために鼻組織または副鼻腔組織に送達され得る。例えば、いくつかの変形形態において、1つ以上の化学薬剤は、ドライアイを治療するためか、ないしは別の方法で涙液産生応答を促進するために使用され得る。これらの変形形態のうちのいくつかにおいて、化学薬剤は、三叉神経活性化を促進するように構成され得る。化学薬剤は、任意の好適な様式で送達され得る。いくつかの変形形態において、化学薬剤は、本明細書に記載される刺激装置を介して送達され得る。他の変形形態では、化学薬剤は、吸入器、噴霧器、または同様のものを介して送達され得る。他の変形形態では、化学薬剤は、1つ以上の鼻用スプレーまたは点眼薬(これは鼻涙管を介して鼻腔または副鼻腔内へ流出し得る)を介して送達され得る。化学薬剤は、上記に記載される薬剤のうちの1つ以上を含み得る。
上述の通り、いくつかの変形形態において、本明細書に記載される刺激システムは、機械的、熱的、光ベース、及び/または磁気的刺激を提供するために使用され得る。いくつかの変形形態において、刺激装置は、振動エネルギーを鼻組織または副鼻腔組織に送達するために使用され得る。刺激装置が少なくとも部分的に鼻腔内に挿入されるように構成される1つ以上のプロングを備える変形形態(本明細書に記載される電気刺激装置など)では、プロングは、少なくとも部分的に鼻腔内に挿入され、振動され得る。刺激装置が鼻腔または副鼻腔内に埋め込まれる変形形態では、刺激装置の1つ以上の部分は、埋め込まれている間に振動し得る。これらの変形形態のうちのいくつかにおいて、振動は、体の外部に位置付けられる1つ以上の磁石を使用して発生され得る。
本明細書に記載される刺激方法は、病態を治療するための1つ以上の治療計画に従って送達され得る。例えば、ドライアイを治療するために、刺激は、必要に応じて、及び/または所定の計画に従って対象に送達され得る。いくつかの例では、使用者は、本明細書に記載される刺激デバイスのうちの1つを使用して、使用者がドライアイの症状を経験するときに一連の刺激を提供し得る。一連の刺激は、任意の好適な間隔を有し得る(例えば、1秒〜10秒の間)。
いくつかの変形形態において、本明細書に記載される治療計画は、ドライアイを治療するために使用され得る。現在のドライアイのための治療の選択肢は限られており、またそれらは一般に、限定された眼の健康の症状の緩和及び改善を提供する。現在の治療の選択肢とは対照的に、本明細書に記載される刺激装置を使用した治療計画は、涙液産生、患者の症状、ならびに角膜及び結膜染色を含む多数の指標によって測定されるときに、眼の健康の迅速かつ顕著な緩和及び改善を提供し得る。達成され得る目の健康の緩和及び改善の速度及び規模はどちらも、既存の治療によってドライアイを治療するはるかに低く、より限定された能力を考慮すると、驚くべきものである。いくつかの変形形態において、本明細書に記載される刺激を提供する治療計画は、鼻涙腺反射の定期的または規則的な活性化を引き起こすことができ、それは次に、ドライアイを治療する、及び/または眼の健康を改善することができる。鼻涙腺反射の定期的または規則的な活性化は、いくつかの作用の機構によって眼の健康を改善し得る。例えば、鼻涙腺反射の活性化は、涙液分泌を引き起こすことができ、それは次に、涙液中に含有される成長因子を眼表面に送達し得る。これらの成長因子としては、上皮成長因子(EGF)が挙げられる。EGFは、角膜、結膜、及び胚細胞を含む種々の組織の成長を刺激するポリペプチドである。ドライアイを持つ患者において、角膜は、乾燥及び炎症のため損傷される可能性があり、EGFはしたがって、角膜のための治療プロセスの刺激においてある役割を果たし得る。鼻涙腺反射の定期的または規則的な活性化はまた、眼表面の慢性的水和を促進し得る休止している涙液産生を増加させることによって、及び活性化中に涙液産生の定期的または規則的な著しい増加を引き起こすことによって、眼の健康を改善し得る。鼻涙腺反射の活性化はまた、血管拡張を引き起こすことによって眼の健康を改善することもでき、それは次に、眼の健康を促進し得る。
Claims (15)
- 対象の鼻組織を刺激するためのデバイスであって、
刺激装置本体と、
前記刺激装置本体に接続された刺激装置プローブであって、各々が電極を有する一対の鼻挿入プロングを備える、刺激装置プローブと、を備え、
前記刺激装置本体が、前記刺激装置プローブの鼻挿入プロングの電極を介して前記対象に送達される刺激を制御する制御サブシステムを備え、
前記電極は中心角が110度ないし270度の間の円弧状表面を有し、
前記各電極が、鼻の前部に向き互いに向き合うように、前記電極の中心が、前記一対の鼻挿入プロングの各々の中心軸を結ぶ線に対して、15度から75度の角度をなすように配置され、
ことを特徴とするデバイス。 - 前記少なくとも2つの鼻挿入プロングが、可撓性であり、前記対象の鼻孔に挿入されると自己整列する、
請求項1に記載の前記デバイス。 - 前記電極がヒドロゲルを含む、
請求項1に記載の前記デバイス。 - 前記電極が、白金、白金−イリジウム、金、またはステンレス鋼のうちの1つ以上を含む、
請求項1に記載の前記デバイス。 - 前記刺激装置プローブが、前記刺激装置本体に解放可能に接続される、
請求項1に記載の前記デバイス。 - 前記デバイスが、前記刺激装置プローブが前記刺激装置本体から切断された後に前記刺激装置本体に再接続されるとき、前記対象への刺激送達を阻止する、無効化機構を備える、請求項5に記載の前記デバイス。
- 前記デバイスが、前記刺激装置プローブが前記刺激装置本体から切断された後に前記刺激装置本体に再接続されることを阻止する、ロックアウト機構を備える、
請求項5に記載の前記デバイス。 - 前記刺激装置本体が再使用可能であり、前記刺激装置プローブが使い捨てである、
請求項5に記載の前記デバイス。 - 取り外し可能な保護キャップをさらに備える、
請求項1に記載の前記デバイス。 - ユーザインターフェースをさらに備える、
請求項1に記載の前記デバイス。 - 前記ユーザインターフェースが、前記刺激の1つ以上のパラメータを調整する1つ以上の動作機構を備える、
請求項10に記載の前記デバイス。 - 前記ユーザインターフェースが、1つ以上のフィードバック要素を備える、
請求項10に記載の前記デバイス。 - 対象の鼻組織を刺激するためのシステムであって、
刺激装置であって、
電極を有する鼻挿入プロングを備える刺激装置プローブ、ならびに
充電式の動力源、及び前記鼻挿入プロングを介して前記対象に送達される刺激を制御する制御サブシステムを備える、刺激装置本体を備える、刺激装置と、
前記充電式の動力源を充電するベースステーションと、を備え、
前記電極は中心角が110度ないし270度の間の円弧状表面を有し、
前記各電極が、鼻の前部に向き互いに向き合うように、前記電極の中心が、前記一対の鼻挿入プロングの各々の中心軸を結ぶ線に対して、15度から75度の角度をなすように配置され、
ことを特徴とするシステム。 - 前記刺激装置が、データを記憶するメモリを備え、前記ベースステーションが、前記刺激装置からデータを取り出すように構成される、
請求項13に記載の前記システム。 - 前記刺激装置プローブが、前記刺激装置本体に取り外し可能に接続でき、前記刺激装置プローブが、前記刺激装置本体に接続されているときに前記充電式の動力源へのアクセスを遮断する、
請求項13に記載の前記システム。
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