JP2017533036A - 様々な疾患のための処置の化学的アブレーションおよび方法 - Google Patents
様々な疾患のための処置の化学的アブレーションおよび方法 Download PDFInfo
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
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- A—HUMAN NECESSITIES
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- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
Abstract
Description
本願は、2014年10月30日出願の米国仮特許出願第62/122,818号、2015年1月5日出願の米国仮特許出願第62/124,868号、米国仮特許出願第号に基づく優先権を主張し、これらの開示は、出典明示により本明細書の一部とする。
本発明の実施態様は、高血圧、肺高血圧、糖尿病、肥満、心不全、末期腎臓疾患、消化器疾患、癌、腫瘍、疼痛、喘息および慢性閉塞性肺疾患(COPD)のための処置の化学品注入デバイス、製剤および方法に関する。デバイスは、バルーンおよび注入カテーテルの組合せ、および他の送達デバイスを含み得る。製剤は、1以上の成分のガス、蒸気、液体、溶液、エマルジョンおよび懸濁液を含み得る。方法は、化学品注入により人体中の標的組織への製剤の送達を含む。
体積/表面積 = (D12 - D22) + (4*D1) ............式1
式中、D1は大直径バルーン部分の直径であり、D2は小直径バルーン部分の直径である。
(1) L(i) = L(ii);バルーンが従来の方法と用いて組立てられる場合。
(2) L(i) > L(ii);バルーンが新しい方法を用いて組立てられる場合。
バルーンコーンの長さに応じて、この新しい注入カテーテルは、少なくとも25%がコーンの内側に、または50もしくは100%がコーン内側に、または部分的もしくは完全にバルーン本体の内側にコーン/ウエスト移行点を有する。
例示の目的で、遠位側および近位側の両方に5 mmのコーン長さを有する8 x 20 mm バルーンに関する例を考える。この場合、L(i) = 本体長さ + 遠位コーン長さ + 近位コーン長さ = 20 + 5 + 5 = 30 mm。状況1:コーン/ウエスト移行点が50%コーンの内側に配置される場合、L(ii) = 20 + 2.5 +2.5 = 25mm;L(i)> L(ii)。状況2:コーン/ウエスト移行点が100%コーンの内側またはコーン/本体の移行線部に配置される場合、L(ii) = 20 + 0 + 0 = 20mm;L(i) > L(ii)。ウエストが内側にさらに配置される場合、それはバルーン本体の内側に位置する。
Claims (38)
- a)体腔へ送達カテーテルを挿入し;
b)体腔中の疾患組織へ製剤を注入し、ここで体腔に送達される製剤の量が、疾患症状を緩和するために疾患組織を傷つけるかまたは損傷するのに有効であり;
c)疾患組織から製剤を取り除いてもよく;そして
d)体腔から送達カテーテルを引き抜くこと
を含む、疾患を処置するための方法。 - 疾患が高血圧、肺高血圧、糖尿病、肥満、心不全、末期腎臓疾患、消化器疾患、良性前立腺過形成、癌、腫瘍、疼痛、喘息および慢性閉塞性肺疾患(COPD)から選択される、請求項1に記載の方法。
- 癌が副腎、膀胱、頚部、結腸、食道、胆嚢、腎臓、肝臓、肺、卵巣、膵臓、前立腺、直腸、胃、十二指腸、空腸および子宮から選択される、請求項2に記載の方法。
- 体腔が腎動脈、肺動脈、血管内腔、腹腔動脈、総肝動脈、固有肝動脈、十二指腸動脈、右肝動脈、左肝動脈、脾動脈、右胃動脈、左胃動脈、非血管内腔、気道、副鼻腔、食道、呼吸器の内腔、消化器の内腔、胃、十二指腸、空腸、前立腺、尿道、輸尿管および/または泌尿器の内腔から選択される、請求項1に記載の方法。
- 製剤が本質的にエタノールからなる、請求項1に記載の方法。
- 製剤がエタノールからなる、請求項1に記載の方法。
- 製剤が1以上の成分のガス、蒸気、液体、溶液、エマルジョンまたは懸濁液を含む、請求項1に記載の方法。
- 製剤が1以上の成分の蒸気を含む場合、熱が蒸気の液体への凝縮により発生する、請求項7に記載の方法。
- 製剤が液体または溶液を含む場合、熱が製剤から疾患組織へ移される、請求項7に記載の方法。
- 製剤がエマルジョンまたは懸濁液を含む場合、熱が製剤から疾患組織へ移される、請求項1に記載の方法。
- 製剤が40℃〜140℃の範囲の温度である、請求項1に記載の方法。
- 製剤が0℃〜140℃の範囲の温度である、請求項1に記載の方法。
- 製剤が-40℃〜0℃の範囲の温度である、請求項1に記載の方法。
- 製剤が室温に等しい温度である、請求項1に記載の方法。
- 疾患組織の温度が製剤の温度より低い、請求項1に記載の方法。
- 疾患組織の温度が製剤の温度より高い、請求項1に記載の方法。
- 注入中の製剤の圧力が0.1 atm〜14 atmの範囲である、請求項1に記載の方法。
- 疾患組織が-40℃〜100℃の範囲の温度である、請求項1に記載の方法。
- 疾患組織が-40℃〜0℃の範囲の温度である、請求項1に記載の方法。
- 疾患組織が体温に等しい温度である、請求項1に記載の方法。
- 注入中の製剤の圧力が約-40℃〜150℃の範囲の温度において約2 psi〜200 psiの範囲である、請求項1に記載の方法。
- 疾患組織へ注入される製剤の量が0.2マイクロリットル〜200ミリリットルの範囲である、請求項1に記載の方法。
- 方法が送達カテーテルを体腔へ約2秒〜約60分間挿入することを含む、請求項1に記載の方法。
- 方法が疾患組織へ約2 cal/g〜約150 cal/gの範囲の熱またはエネルギーの量を送達する、請求項1に記載の方法。
- 送達カテーテルが針または針-ベース送達カテーテル、シングルバルーン送達カテーテル、ダブルバルーン送達カテーテル、注入カテーテル、バルーン注入カテーテル、バルーンカテーテル、ダンベルバルーン注入カテーテル、およびそれらの組合せから選択される、請求項1に記載の方法。
- 送達カテーテルが0.1 atm〜14 atmの範囲の圧力で膨らむ、請求項25に記載の方法。
- 製剤が、水、生理食塩水、高張生理食塩水、フェノール、メタノール、エタノール、無水アルコール、イソプロパノール、プロパノール、ブタノール、イソブタノール、エチレングリコール、グリセロール、酢酸、乳酸、ヨウ化プロピル、ヨウ化イソプロピル、ヨウ化エチル、酢酸メチル、酢酸エチル、硝酸エチル、酢酸イソプロピル、乳酸エチル、リピオドール、尿素、およびそれらの誘導体ならびにそれらの組合せから選択される1以上の成分を含む、請求項1に記載の方法。
- 製剤が、酸素、窒素、ヘリウム、アルゴン、空気、二酸化炭素、一酸化窒素、水、フェノール、メタノール、エタノール、無水アルコール、イソプロパノール、プロパノール、ブタノール、イソブタノール、エチレングリコール、グリセロール、酢酸、乳酸、ヨウ化プロピル、ヨウ化イソプロピル、ヨウ化エチル、酢酸メチル、酢酸エチル、硝酸エチル、酢酸イソプロピルおよび乳酸エチル、ならびにそれらの混合物から選択されるガスまたは蒸気を含む、請求項1に記載の方法。
- 製剤が除神経のための治療薬を含み、該治療剤がナトリウムチャネルブロッカー、テトロドトキシン、サキシトキシン、脱カルバモイルサキシトキシン、バニロイド、ネオサキシトキシン、リドカイン、コノトキシン、強心配糖体、ジゴキシン、グルタメート、スタウロスポリン、アムロジピン、ベラパミル、シマリン、ジギトキシン、プロスシラリジン、ウアバイン、ベラトリジン、ドウモイ酸、オレアンドリン、カルバマゼピン、アフラトキシン、グアネチジンおよび硫酸グアネチジンから選択される、請求項1に記載の方法。
- 製剤が除神経を画像化するための造影剤を含み、該造影剤がヨウ素、ヨウ化エチル、ヨウ化ナトリウム、リピオドール、ノノキシノールヨード、イオビトリドール、イオヘキソール、イオメプロール、イオパミドール、イオペントール、イオプロミド、イオベルソール、イオキシラン、イオトロラン、イオジキサノール、またはイオキサグレート、およびそれらの誘導体から選択される、請求項1に記載の方法。
- 製剤が共沸混合物を含む、請求項1に記載の方法。
- 共沸混合物がエタノール/水、プロパノール/水、イソプロパノール/水、ブタノール/水、酢酸/水、乳酸/水、乳酸エチル/水、乳酸エチル/エタノール、乳酸/エタノール/水、乳酸エチル/水/エタノール、酢酸エチル/エタノール、硝酸エチル/エタノール、および酢酸イソプロピル/エタノールから選択される、請求項31に記載の方法。
- 製剤がエタノール、エタノール/水、エタノール/水/酸素、エタノール/水/空気、エタノール/水/造影剤、エタノール/水/界面活性剤、エタノール/水/造影剤/界面活性剤、プロパノール/水、イソプロパノール/水、ブタノール/水、および/または酢酸/水の1つを含む、請求項1に記載の方法。
- 患者の体腔中の標的位置への製剤の送達のための膨張するバルーンカテーテルであって、膨張するバルーンカテーテルは近位端、遠位端、ワイヤールーメン、バルーン膨張ルーメン、製剤注入ルーメンおよび/または真空ルーメン、膨張可能バルーンおよび膨張不能シャフトを含み、膨張可能バルーン部および/または膨張不能シャフトは複数の空隙を有する第1部を少なくとも含み、空隙はマイクロホールであり、膨張可能バルーン部および/または膨張不能シャフトは空隙を有しない第2部を少なくとも含む、膨張するバルーンカテーテル。
- 膨張可能部が第1遠位、第1中央部および第1近位部を有し、第1遠位部および第1近位部の直径が第1中央部の直径より大きい、請求項34に記載の膨張するバルーンカテーテル。
- 膨張可能部または膨張不能部が、体腔より高い圧力の体腔壁への製剤の透過を可能にする少なくとも1つの空隙を有し;膨張可能部または膨張不能部が、体腔より高い圧力の体腔をバルーンが膨張することを可能にする空隙を有しない、請求項34に記載の膨張するバルーンカテーテル。
- 体腔が腎動脈、肺動脈、血管内腔、腹腔動脈、総肝動脈、および固有肝動脈、十二指腸動脈、右肝動脈、左肝動脈、脾動脈、右胃動脈、左胃動脈、非血管内腔、気道、副鼻腔、食道、呼吸器の内腔、消化器の内腔、胃、十二指腸、空腸、前立腺、尿道、輸尿管、および泌尿器の内腔から選択される、請求項34に記載の膨張するバルーンカテーテル。
- 製剤が送達中0.1 atm〜14 atmの範囲の圧力であり、膨張されるバルーンカテーテルが0.1 atm〜14 atmの範囲の圧力において膨らむ、請求項34に記載の膨張するバルーンカテーテル。
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CN113040895A (zh) | 2021-06-29 |
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US20200009355A1 (en) | 2020-01-09 |
JP2023027052A (ja) | 2023-03-01 |
WO2016070032A1 (en) | 2016-05-06 |
JP2021046397A (ja) | 2021-03-25 |
CN107106820B (zh) | 2021-03-19 |
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