JP7288699B2 - 治療薬の送達のための方法および装置 - Google Patents
治療薬の送達のための方法および装置 Download PDFInfo
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- JP7288699B2 JP7288699B2 JP2021106878A JP2021106878A JP7288699B2 JP 7288699 B2 JP7288699 B2 JP 7288699B2 JP 2021106878 A JP2021106878 A JP 2021106878A JP 2021106878 A JP2021106878 A JP 2021106878A JP 7288699 B2 JP7288699 B2 JP 7288699B2
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Description
本出願は、全体において参照により本明細書に組み込まれる、2016年3月28日出願の米国仮特許出願第62/314,286号の利益を主張する。
本明細書に記載されるシステム、方法および装置のいくつかの実施形態では、治療薬投与は従来の針-シリンジを使用して行なわれる。EMTADを用いて特定の薬剤を送達する必要は、TAAの問題にさらなるレベルの複雑さをもたらす。図1に図解されるように、従来の針-シリンジ注入では、針(5)が組織に挿入されると、組織(3)の表面に対する挿入の深さ(1)および角度(2)を制御するのは困難であり得る。付加的に、組織表面(3)における針の貫通点(4)は、標的組織内のオリフィス(6)の位置、および薬剤投与領域(7)を表すものではないかもしれない。例示的な例のように、経皮的な筋肉内注射は、2つの組織がしばしば互いに対して動き得るために、皮膚上の挿入部位に対応しないかもしれない。
従来の針-シリンジ注入によるTAAの場合には、注入速度は手術者間で異なり、それによって組織内での一貫しない薬剤分配を引き起こし得る。多数のデバイス配置がEMTADプロセスを完了するために求められる場合、追加の時間的な変動性がもたらされる。例えば、EMTADの1つの適用は、治療用タンパク質をコードするプラスミドDNAの投与、続いて電気穿孔を誘導する電界の生成を必要とする。EMTADの従来の方法を使用して、プラスミドは針-シリンジを用いて注入され、続いて電気穿孔デバイスが配置および活性化される。2つの別個のデバイス配置(最初の針-シリンジ、続くESAデバイス)が求められることで、この手順は、手術者による各デバイスの一貫しない時間的な適用から生じる被験体間の変動性をこうむりやすい。付加的に、2つの別個のデバイス配置の使用は、臨床医による各デバイスの配置と活性化との間に、避けることのできない時間間隔をもたらす。標的組織内の特定の領域への薬剤の適切な送達を達成するために、多数の適用部位が必要とされる場合、これはいっそうひどくなる。
用語「治療薬」は、生きている組織に望ましいまたは有益な効果を提供することができる薬剤を含む、その最も広い意味で、本明細書において使用される。したがって、該用語は、予防薬と治療薬の両方、およびそのような望ましい効果を有する他のカテゴリーの薬剤をも含む。明らかに、本開示の範囲は、分類されてはいるが、薬剤の制御された送達を含むだけ十分に広い。治療薬は、限定されないが、医薬薬剤およびワクチン、および核酸配列(超らせん構造を有する弛緩型の直鎖プラスミドDNA、RNA、アンチセンス構成物、人工染色体、または他の核酸塩基治療薬)、およびそれらの製剤を含む。そのような薬剤の処方は、限定されないが、カチオン性脂質、陽イオンおよび/または非イオンポリマー、リポソーム、食塩水、ヌクレアーゼ阻害剤、麻酔剤、ポロキサマー、保存剤、リン酸ナトリウム溶液、または治療薬の投与、安定性、および/または効果を改善することができる他の化合物を含む。さらなる処方は、投与された薬剤の粘度および電気的なインピーダンスを制御する性能を付与する薬剤と添加物を含む。
本明細書に記載される方法、装置およびシステムの使用によるEMTADによく適した標的組織は、例えば表皮、真皮、下皮、結合組織、および筋組織に位置する、健康な細胞と罹病細胞の両方を含む。当該技術はさらに、最小限の侵襲的な方法または他の外科的方法によってアクセスされなければならない、健康な器官または罹病器官での適用のために利用することができる。そのような標的組織は、肝臓、肺、心臓、血管、リンパ、脳、腎臓、膵臓、胃、腸、結腸、膀胱、および生殖器を含む。いくつかの実施形態では、所望の治療効果は、通常は標的組織内に位置する細胞型への、および前記組織内に例外的に見つかった他の細胞型への、ある量の薬剤の送達のために(例えば腫瘍の化学療法処置)、本明細書に記載の方法または装置を使用することによって導き出され得る。
一態様では、本明細書に記載される本開示は、治療薬の制御された投与と続くESAのための方法で使用されるシステムおよび装置を提供する。別の態様では、本明細書に記載される本開示は、ESA後の治療薬の制御された投与のための方法で使用されるシステムおよび装置を提供する。さらなる態様では、本明細書に記載される本開示は、ESAを伴う治療薬の制御された投与のための方法で使用されるシステムおよび装置を提供する。これらの方法は、範囲または連続的関係の点で限定されないが、処置パラメータの判定、被験体の準備手順、CTAA、ESA、および追加措置を含む。
いくつかの実施形態では、処置パラメータは、治療薬の望ましい量および/または投与の持続期間に基づく。治療薬投与は、例えば、特定の徴候または処置適用(標的組織の種類および位置など)、および様々な被験体パラメータ(年齢と体重など)に依存し得る。治療薬の投与は、治療薬の投与とESAに関するパラメータによって制御され得る。CTAAに関する典型的な制御可能パラメータは、限定されないが、薬剤の量、薬剤の粘度、および注入量を含む。ESAに関する典型的な制御可能パラメータは、限定されないが、電気信号の特性、電気信号に曝される組織量、および電極列フォーマットを含む。CTAAとESAの相対的なタイミングおよび位置は、治療薬投与に対するさらなる制御を提供するパラメータである。
本明細書に記載の実施形態では、本明細書に記載される方法は、患者/被験体の準備工程を含んでもよい。被験体の準備工程は、限定されないが、消毒清浄、および局部または局所的、神経ブロック、脊髄ブロック、硬膜外ブロックまたは全身麻酔を含む麻酔投与を含んでもよい。筋肉内(IM)ESAの典型的な事例では、筋肉の電気刺激の効果を最小化するプロトコルが本明細書に記載の方法に含まれてもよく、例えば、熱制御(例えば筋肉を冷やす)、麻酔剤の投与、および/または不快感の緩和に十分な代替的な刺激パターンを含む。容認可能な代替手段が存在する場合、選ばれた被験体の準備技術は、治療の有効性に不利に影響しないことが理解されるよう。例えば、場合によっては、アミド系麻酔剤の筋内投与は、推定ではこれらの薬剤の軽い筋毒性、すなわち投与されたDNA塩基配列によってコードされるタンパク質を発現する筋細胞の性能を阻害することができる筋毒性ゆえに、筋肉内送達プラスミドDNA系治療に望ましくない効果を有し得ることが示されてきた。
本明細書に記載されるいくつかの実施形態では、CTAAとESAが併用される方法は、一貫したおよび再現可能な治療薬送達を可能にする。場合によっては、CTAAに適した装置が提供され、例えば、自動注射器具およびジェットインジェクターの少なくとも1つを含む装置が含まれる。
上肢又は下肢の骨格筋における核酸配列の細胞内輸送は、典型的なデバイス、例えば、本明細書で提供されるようなTriGrid Delivery System(TDS-IM)model IIの使用により増強され得る。幾つかの実施形態において、TDS-IMデバイスは、TDS-IMデバイスでの研究目的の使用のために承認された薬剤と共に使用される。典型的な実施形態において、承認された薬剤は、核酸、即ちDNA又はRNAである。幾つかの実施形態において、TDS-IMデバイスの使用は、必要とする被験体に制限される。
Claims (29)
- 被験体内の予め決められた組織部位への治療薬の制御された送達のための装置であって、該装置は、
針ハブと、治療薬を含む容器を受け入れるように構成された容器レシーバーとを含むカートリッジアセンブリ、
カートリッジアセンブリレシーバーと容器挿入検出器とを含むアプリケーターであって、前記容器挿入検出器は、前記容器レシーバー内への容器の装着を感知するように構成される、アプリケーター、
注射針の少なくとも1つの注入オリフィスであって、そこを通って治療薬が投与される、注入オリフィス、
ある標的組織深度まで前記被検体中に挿入されるように構成された、複数の貫通電極、
複数のアパーチャを含む電極支持体であって、前記複数のアパーチャは前記貫通電極の所定の空間的関係に対応し、および前記貫通電極は前記複数のアパーチャを通って伸長し、前記電極支持体は、摺動可能に複数の前記貫通電極に係合され、前記貫通電極が標的組織深度まで挿入されるときに互いの前記貫通電極との空間的関係又は前記注射針と前記貫通電極との空間的関係を維持するために少なくとも一つの位置、サイズおよび形態の変化を受けるように構成されており、
前記貫通電極に動作可能に接続され、電気信号を生成するように構成された電界発生装置、および
容器から前記注入オリフィスを通って被験体内の予め決められた部位へと、所定の速度で治療薬の所定量を運ぶのに十分な制御されたエネルギー源、
を含む、装置。 - 前記装置はさらに針を含むことを特徴とする、請求項1に記載の装置。
- 前記装置が、電極挿入バネまたは針挿入バネをさらに備える、請求項1に記載の装置。
- 前記貫通電極の近位部は、電極肩部または電極屈曲部によって前記貫通電極の遠位部から分離されることを特徴とする、請求項1に記載の装置。
- 前記電極支持体は注射針の通過を可能にするように位置づけられた針穴を含むことを特徴とする、請求項1に記載の装置。
- 前記電極支持体は前記貫通電極の伸縮配向に対して垂直に位置づけられた平面構造を含むことを特徴とする、請求項1に記載の装置。
- 前記複数のアパーチャのうちの少なくとも1つのアパーチャが、平面構造に垂直に配置された少なくとも1つの管状構造を含む、請求項6に記載の装置。
- 前記平面構造は前記貫通電極の長手方向軸に垂直に配向される、請求項6に記載の装置。
- 前記電極支持体が、前記貫通電極の展開中に前記貫通電極の相対位置に厳密に一致する、適応性のある電極支持体である、請求項1に記載の装置。
- 適応性のある前記電極支持体が圧縮バネである、請求項9に記載の装置。
- 前記圧縮バネは金属、ポリマーまたはエラストマー材料から作られる、請求項10に記載の装置。
- 前記電極支持体が、少なくとも1つの入れ子式チューブを含む、請求項1に記載の装置。
- 前記電極支持体が、金属、ポリマー、セラミック、複合材料、または圧縮性マトリックス材料を含む、請求項1に記載の装置。
- 前記圧縮可能なマトリックス材料は、セルロース、発泡プラスチック、ゴムポリマー、マイクロセルラープラスチック、発泡シリコン、発泡ポリクロロプレン、炭素発泡体マトリックスから成る群から選択される、請求項13に記載の装置。
- 前記電極支持体は非導電性材料で作られる、請求項1に記載の装置。
- 前記電極支持体は熱可塑性材料で作られる、請求項1に記載の装置。
- 熱可塑性材料は、ポリカーボネート、ポリスチレン、ポリプロピレン、アクリル樹脂、またはポリエチレンから成る群から選択される、請求項16に記載の装置。
- 前記電極支持体が前記貫通電極の経皮的配置を支持し、および、最大60mmの前記標的組織深度を維持する、請求項1に記載の装置。
- 制御装置と力接触回路をさらに含む装置であって、ここで前記予め決められた組織部位への複数の前記貫通電極の挿入に際して、適用された力における変化を検知することで、電極が前記予め決められた組織部位で配置され続けているかどうかのチェックが開始されるように促されるように、フィードバックループが前記制御装置と前記力接触回路との間に存在する、請求項1に記載の装置。
- 前記カートリッジアセンブリは、各貫通電極の近位部分に動作可能に接続された1つまたは複数の電極接触部をさらに含み、各前記電極接触部は、アプリケーター上の電極接触部との電力通信のために構成された外側カートリッジ接触部を含み、前記アプリケーター上の電極接触部および各前記外側カートリッジ接触部は、それらの間に静的インターフェースを有する、請求項1に記載の装置。
- 前記アプリケーターは、注射駆動モーターおよび注射駆動プランジャーを含み、ここで、制御されたエネルギー源は注射駆動モーターであり、前記注射駆動モーターは、治療薬の移動を可能にするように前記注射駆動プランジャーを動かすように構成される、請求項1に記載の装置。
- 前記カートリッジアセンブリは、スティックシールドおよびスティックシールド支持体をさらに含み、前記スティックシールドは前記貫通電極または/および前記注射針を覆うことができ、前記スティックシールド支持体は、前記スティックシールドに当接し、前記スティックシールドがラチェット式に近位方向に移動するのを防止する、請求項1に記載の装置。
- 前記電極支持体が、前記スティックシールドに対応するバネをさらに備える、請求項22に記載の装置。
- 前記スティックシールド支持体は、少なくとも5Nの力が前記スティックシールドに加えられたときに、前記スティックシールドが近位方向に移動するのを防止する、請求項22に記載の装置。
- 前記スティックシールドは、第1の選択された深さで前記装置が放電された場合に前記スティックシールドの近位方向の動きを防ぐことができる第1の擁壁と、被検体内の第2の選択された深さで前記装置が放電された後に前記スティックシールドの近位方向の動きを防ぐことができる第2の擁壁を備えた、請求項22に記載の装置。
- 前記カートリッジアセンブリは、被験体の皮膚と係合し、組織部位への治療薬の投与のために、前記注射針の配置の方向に垂直に引っ張り装置を配置するリブおよびエッジを含むスプレイシールドをさらに含む、請求項1に記載の装置。
- 被験体に対して加えられた力を感知し、不十分な力が加えられたときに被検体への治療薬の投与を防止する力インターロックをさらに備える、請求項1に記載の装置。
- 前記力インターロックが、前記アプリケーター内に電気ロックをさらに形成する、請求項27に記載の装置。
- 力が、少なくとも1つのカートリッジ力センサーとの接触点をさらに含む、請求項27に記載の装置。
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