KR20130131471A - 신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 및 방법 - Google Patents

신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 및 방법 Download PDF

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KR20130131471A
KR20130131471A KR1020137026368A KR20137026368A KR20130131471A KR 20130131471 A KR20130131471 A KR 20130131471A KR 1020137026368 A KR1020137026368 A KR 1020137026368A KR 20137026368 A KR20137026368 A KR 20137026368A KR 20130131471 A KR20130131471 A KR 20130131471A
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balloon
drug delivery
iontophoretic
drug
catheter
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피터 에프. 마이어
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코비디엔 엘피
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0444—Membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0432—Anode and cathode
    • A61N1/044—Shape of the electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0448—Drug reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A61N1/303—Constructional details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/325—Applying electric currents by contact electrodes alternating or intermittent currents for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Abstract

본 발명은 신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 (100) 및 방법에 관한 것이다. 상기 시스템은 약물 코팅된 벌룬 (112)이 구비된 이온영동 카테터 (110)를 포함한다. 상기 이온영동 카테터는 그의 말단 첨단부 또는 단부 부근에서 팽창되면 원주형으로 혈관 벽에 접촉하게 되는 벌룬을 포함한다. 벌룬 표면에는 하나 이상의 전극 (118)이 결합되는데, 벌룬의 외부 표면상에 배치될 수 있다. 상기 전극은 2개의 벌룬 전극들 사이에 및/또는 하나의 벌룬 전극과 환자의 신체 일부에 접촉되어 위치하는 또 다른 전극 사이에 쌍극자 또는 단극자 전기장을 생성하도록 구성되는 에너지 공급원 (122)과 작용가능하게 연결된다. 사용시, 개시되는 약물-전달 카테터는 인접 조직 내에 전위 구배를 생성시키며, 그것은 다시 약물의 이온영동 전달을 촉진한다. 개시되는 카테터는 또한 표적 조직에 전달될 1종 이상 약물의 비축분을 포함할 수 있다.

Description

신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 및 방법{IONTOPHORESIS DRUG DELIVERY SYSTEM AND METHOD FOR DENERVATION OF THE RENAL SYMPATHETIC NERVE AND IONTOPHORETIC DRUG DELIVERY}
본 개시는 신장 신경차단 및 혈관내 약물 전달에 관한 것이다. 더 구체적으로, 본 개시는 신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 카테터 시스템 및 방법에 관한 것이다.
만성적인 혈압 상승 또는 고혈압은 심장 질환 및 사망의 중요 원인이며, 세계적으로 수백만명이 시달리고 있다. 일반적으로, 만성적인 140 mmHg를 초과하는 수축기 혈압 및 90 mmHg를 초과하는 확장기 혈압을 가지는 사람은 고혈압에 걸린 것으로 분류된다. 신장 교감 신경 활성이 혈압의 상승을 개시하여 지속시키는 것으로 여겨지고 있다. 신장 신경은 신장 동맥 주변에 다발을 이루는데, 대퇴 동맥을 통하여 용이하게 접근가능하다. 신장 신경차단이 혈압을 감소시키는 것으로 밝혀져 있다.
고혈압의 치료를 위한 통상적인 신장 신경차단 방법에는 몇 가지 단점이 존재한다. 통상적인 방법은 신장 동맥 중 몇몇 개별 부위에 대한 강력한 열의 적용을 포함하는데, 이는 환자에게 매우 고통스러울 수 있으며, 회복 시간을 증가시킬 수 있다. 또한, 강력한 열의 적용은 흐름을 제한하는 협착을 발생시킬 수 있다. 또 다른 단점은 동맥 벽 내의 신경 다발의 정확한 위치를 알지 못한다는 것과 관련된다. 따라서, 신장 신경 기능이 감쇠될 가능성을 증가시키기 위해서는 다수의 부위가 치료되어야 한다.
또 다른 단점에는 치료시 혈관 벽과의 병치(apposition)을 유지함에 있어서의 어려움이 포함된다. 또한, 통상적인 신장 신경차단 치료 시스템 및 방법은 흐름을 제한하는 협착의 생성을 방지하기 위하여 각 부위의 치료 후 카테터를 길이방향으로 움직임은 물론, 카테터를 회전시킬 필요가 있다. 따라서, 통상적인 신장 신경 신경차단 시스템 및 방법의 단점들을 극복한 신장 신경 신경차단 시스템 및 방법이 향후 환영받게 될 것이다.
[발명의 개요]
본 개시에 따라, 신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 및 방법이 제공된다. 본 시스템은 환자 내부에 개재하여 위치되도록 구성되는 이온영동 카테터를 포함한다. 일부 실시양태에서, 상기 이온영동 카테터는 신장에 인접한 하행 대동맥 및/또는 하나 이상 신장 동맥 분지 사이의 신장 동맥의 내강에 위치되도록 구성된다. 상기 약물 전달 카테터는 그의 말단 첨단부(tip) 또는 단부 부근에 팽창되면 원주형으로 혈관 벽에 접촉하게 되는 벌룬을 포함한다.
벌룬 표면에는 하나 이상의 전극이 결합되는데, 일부 실시양태에서, 상기 전극은 벌룬의 외부 표면상에 배치된다. 상기 전극은 에너지 공급원과 작용가능하게 연결된다. 상기 에너지 공급원은 2개의 벌룬 전극들 사이에 (예컨대 쌍극자 모드), 및/또는 하나의 벌룬 전극과 환자의 신체 일부, 예컨대 비제한적으로 피부, 혈관 등과 접촉되어 위치하는 또 다른 전극 사이에 (예컨대 단극자 모드) 쌍극자 또는 단극자 전기장을 생성하도록 구성된다. 에너지 공급원은 에너지 전달을 조절하고 모니터링하도록, 및/또는 관련 파라미터 (조직 임피던스, 접촉 온도, 조직 온도 등)를 모니터링하도록 구성되는 제어 시스템을 포함할 수 있다. 일부 실시양태에서, 에너지 공급원은 정전류 직류 (DC) 에너지를 제공한다.
상기 전기장은 연속형 또는 펄스형(pulsed) 직류일 수 있다. 사용시, 개시되는 카테터는 인접 조직 (예컨대 혈관 벽, 신경 및 주위 조직) 내에 전위 구배를 생성시키며, 그것은 다시 약물의 이온영동 전달을 촉진한다.
개시되는 카테터는 또한 표적 조직에 전달될 1종 이상 약물의 비축분(store)을 포함할 수 있다. 본 개시에 따른 실시양태에서, 약물은 벌룬 외부 표면상의 코팅으로 제공될 수 있다. 본 개시에 따른 일부 실시양태에서, 벌룬은 벌룬 내강에 대한 약물의 투여가 전극(들)에 인접한 벌룬 외부 표면으로의 그의 전달을 야기하도록 천공된다 (예컨대 점적식(weeping) 벌룬).
본 개시에 따른 일부 실시양태에서, 약물은 벌룬의 외부 표면과 연결된 웰 내에 제공된다. 상기 웰은 벌룬이 팽창될 때 파열됨으로써 웰 내부의 약물을 전극(들) 근처로 방출하는 덮개 층에 의해 덮여있다. 본 개시의 교시 중에는 벌룬의 외부 표면에 1종 이상의 약물을 제공하기 위한 다른 실시양태들이 구상되어 있다. 따라서, 여기에서 기술되는 방법은 방법의 예로 제공되는 것으로써, 제한하는 것으로 간주되어서는 아니 된다.
본 개시의 측면에 따라, 이온영동 약물 전달 시스템이 제공된다. 상기 시스템은 에너지 공급원; 카테터; 카테터의 말단부에 배치되는 벌룬; 벌룬 표면상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및 벌룬과 작용적으로 연결되는 약물 공급원을 포함한다. 상기 약물 공급원은 약물을 선택적으로 방출하도록 구성된다. 약물 공급원은 1종 이상의 약물을 포함한다. 상기 1종 이상의 약물은 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택된다. 에너지 공급원은 상기 하나 이상의 전극에 직류를 전달하도록 구성된다.
일부 실시양태에서, 벌룬의 외부 표면은 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함한다. 상기 하나 이상의 웰은 파열되도록 구성되는 덮개 층을 포함한다.
일부 실시양태에서, 벌룬은 벌룬의 내부와 유통하는 다수의 구멍을 포함한다.
일부 실시양태에서, 약물 공급원은 벌룬의 외부 표면상에 제공되는 코팅이다.
본 개시의 또 다른 측면에 따라, 이온영동 약물 전달 시스템이 제공된다. 상기 시스템은 에너지 공급원; 카테터; 카테터의 말단부에 배치되는 팽창가능한 부재; 팽창가능한 부재상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및 팽창가능한 부재와 작용적으로 연결되는 약물 공급원을 포함한다. 상기 약물 공급원은 약물을 선택적으로 방출하도록 구성된다. 약물 공급원은 1종 이상의 약물을 포함한다. 상기 1종 이상의 약물은 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택된다. 에너지 공급원은 상기 하나 이상의 전극에 직류를 전달하도록 구성된다.
상기 팽창가능한 부재는 벌룬 및 프레임(frame)으로 구성되는 군에서 선택된다. 상기 벌룬의 외부 표면은 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함한다. 상기 하나 이상의 웰은 파열되도록 구성되는 덮개 층을 포함한다. 벌룬은 벌룬의 내부와 유통하는 다수의 구멍을 포함한다. 상기 약물 공급원은 벌룬의 외부 표면상에 제공되는 코팅이다.
본 개시의 또 다른 측면에 따라, 이온영동 약물 전달 카테터가 제공된다. 상기 카테터는 카테터의 말단부에 배치되는 벌룬; 벌룬 표면상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및 벌룬과 작용적으로 연결되는 약물 공급원을 포함한다. 상기 약물 공급원은 약물을 선택적으로 방출하도록 구성된다. 약물 공급원은 1종 이상의 약물을 포함한다. 상기 1종 이상의 약물은 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택된다.
상기 벌룬의 외부 표면은 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함한다. 상기 하나 이상의 웰은 파열되도록 구성되는 덮개 층을 포함한다. 벌룬은 벌룬의 내부와 유통하는 다수의 구멍을 포함한다. 상기 약물 공급원은 벌룬의 외부 표면상에 제공되는 코팅이다.
본 개시의 또 다른 측면에 따라, 신장성 고혈압의 치료 방법이 제공된다. 상기 방법은 신장 동맥의 내강에 약물-전달 카테터를 위치시키는 단계; 카테터와 신장 동맥 벽에 인접한 신경 사이에 전위를 생성시키는 단계; 및 전위를 통하여 신경에 약물을 투여하여 상기 신경의 활성을 감쇠시키는 단계를 포함한다.
본 개시의 또 다른 측면에 따라, 고혈압 환자가 신장 신경차단 절차로부터 이익을 얻을 수 있는지 여부의 확인 방법이 제공된다. 상기 방법은 고혈압 환자의 혈압을 측정하는 단계; 고혈압 환자에게 구아네티딘을 투여하는 단계; 구아네티딘 투여 후 고혈압 환자의 혈압이 변화하는지를 확인하는 단계; 혈압의 변화를 예정된 값과 비교하는 단계; 및 혈압의 변화가 예정된 값을 초과하는 경우, 고혈압 환자에서 신장 신경차단 절차를 수행하는 단계를 포함한다.
본 개시의 다양한 실시양태들에 대한 하기의 상세한 설명으로부터 상기 및 기타 장점들이 더욱 분명해지게 되는데, 도면을 참조하면:
도 1은 하나 이상의 전극을 가지는 약물 코팅된 벌룬이 구비된 본 개시의 실시양태에 따른 이온영동 카테터를 가지는 신장 신경의 신경차단을 위한 이온영동 카테터 시스템의 블록도이고;
도 2는 본 개시의 실시양태에 따른 이온영동 카테터 시스템의 이온영동 카테터 말단부의 확대도이고;
도 3은 도 2에 나타낸 이온영동 카테터 말단부의 단면도이고;
도 4는 본 개시의 또 다른 실시양태에 따른 이온영동 카테터 말단부의 확대도이고;
도 5는 본 개시의 또 다른 실시양태에 따른 이온영동 카테터 말단부의 확대도이다.
이하, 첨부된 기호 및 도면을 사용하여 본 개시의 구체적인 실시양태를 기술하는 바, 개시되는 실시양태는 단순히 개시의 예로써, 다양한 형태로 구현될 수도 있다는 것이 이해되어야 한다. 본원에서 사용되는 용어들은 오로지 구체적인 실시양태를 기술할 목적을 위한 것으로써, 제한하고자 하는 것은 아니다. 불필요하거나 과도한 세부사항으로 본 개시를 불명료하게 하는 것을 피하기 위하여, 잘-알려져 있거나 및/또는 반복되는 기능 및 구성은 상세하게 기술하지 않았다. 따라서, 본원에서 개시되는 구체적인 구조 및 기능적 세부사항들은 제한하는 것으로 해석되어서는 아니 되며, 대신 청구범위의 기초로, 그리고 실제 임의로 적절하게 상세화되는 구조에서 본 개시를 다양하게 사용하기 위하여 당업자에 교시하는 대표적인 기초로만 해석되어야 한다.
본원에서 사용되는 바와 같이, 통상적으로 사용되는 "근접(proximal)"이라는 용어는 사용자에 더 가까운 기기의 단부를 지칭하게 되는 반면, "말단(distal)"이라는 용어는 사용자로부터 더 먼 단부를 지칭하게 된다. 본원에서 사용되는 바와 같이, 방향을 지칭하는 용어, 예컨대 "상부", "저부", "상향", "하향", "좌측", "우측", "~시 방향(o'clock)" 등은 도면 및 상응하는 축 및 거기에서 나타내는 특징들과 관련하여 설명 목적으로 사용된다. 본 개시에 따른 실시양태들은 제한 없이 어떠한 방향으로도 실시될 수 있다는 것이 이해되어야 한다. 본원에서 사용되는 바와 같이, "이온영동"이라는 용어는 혈관 벽과 같은 온전한(intact) 조직을 통과하도록 약물-운반 이온을 자극하는 데에 전류가 사용되는 약물 전달 방법을 지칭한다. 동일한 참조번호의 부재는 동일하거나 유사하거나 등가인 기능을 수행할 수 있는 요소를 나타낼 수 있다.
본 개시에 따른 실시양태에서는, 이온영동 약물 전달 시스템 및 방법들이 제공된다. 각 약물 전달 시스템은 신체 내강에 도입되어 이온영동을 통하여 약물, 약제 또는 기타 치료 물질을 표적 조직에 전달하는 이온영동 카테터를 포함한다. 비제한적인 일 예에서, 개시되는 카테터는 대퇴 동맥으로 도입되어, 신장 동맥으로 전진한 후, 신장 신경 다발에 인접하여 위치될 수 있다. 유리하게도, 본 개시에 따른 이온영동 카테터는 신장 신경 다발에 대한 구아네티딘의 표적화된 전달에 의한 고혈압의 치료를 위한 신장 교감 신경 기능의 감쇠를 가능하게 할 수 있다. 다른 적용분야 및 기타 약물들도 구상된다.
도 1, 2 및 3을 참조하면, 본 개시에 따른 약물 코팅된 벌룬이 구비된 이온영동 카테터를 가지는 신장 신경의 신경차단을 위한 이온영동 약물 전달 시스템의 예시적인 실시양태를 나타낸다. 이온영동 약물 전달 시스템은 전체적으로 참조번호 100으로 표시되어 있다. 시스템 (100)은 신장에 인접한 하행 대동맥 및/또는 하나 이상 신장 동맥 분지 사이의 신장 동맥의 내강에 위치되도록 구성되는 이온영동 카테터 (110)를 포함한다.
도 1에 나타낸 실시양태에서, 카테터 (110)는 그의 말단부 (114) 또는 그 부근에, 팽창될 경우 신장 신경 (119)에 근접한 신장 동맥 (117)의 벽과 같은 혈관 벽 (116)에 원주형으로 접촉하게 되는 팽창가능한 부재 또는 벌룬 (112)을 포함한다. 벌룬 (112)의 표면에는 하나 이상의 전극 (118)이 결합된다. 본 실시양태에서, 전극 (118)은 벌룬 (112)의 외부 표면 (120)상에 배치된다. 전극 (118)은 하나 이상의 와이어 (123)를 통하여 에너지 공급원 (122)에 작용가능하게 연결된다. 에너지 공급원 (122)은 2개의 벌룬 전극들 (118) 사이에 (예컨대 쌍극자 모드), 및/또는 하나의 벌룬 전극 (118)과 환자의 신체 일부, 예컨대 비제한적으로 피부, 혈관 등과 접촉되어 위치하는 또 다른 벌룬 전극 (118) 사이에 (예컨대 단극자 모드) 쌍극자 또는 단극자 전기장을 생성하도록 구성된다.
에너지 공급원 (122)은 에너지 전달을 조절하고 모니터링하도록, 및/또는 관련 파라미터 (조직 임피던스, 접촉 온도, 조직 온도 등)를 모니터링하도록 구성되는 제어 시스템을 포함할 수 있다. 일부 실시양태에서, 에너지 공급원 (122)은 정전류 DC 에너지를 제공한다. 도 1에 나타낸 바와 같이, 복귀 전극(return electrode) (124)을 포함할 수도 있다.
시스템 (100)에 의해 생성되며 도 1에 파선으로 도시되어 있는 전기장은 연속형 또는 펄스형 직류일 수 있다. 전극 (118)은 특정 전기장 구성을 제공하도록 임의의 패턴으로도 벌룬 (112)의 외부 표면 (120)상에 위치될 수 있다. 전극 (118)은 도 2 및 3에 나타낸 바와 같이 동일하게 이격된 패턴으로 위치될 수 있거나, 및/또는 전극 (118)은 벌룬 (112)의 외부 표면 (120)상의 무작위 위치에 위치될 수 있다.
신장 신경 (119)의 최적의 신경차단을 위하여, 전극 (118)은 생성되는 전기장의 대부분이 신장 신경 (119)에 침투하도록 하는 방식으로 배열될 수 있다. 전극 (118)은 또한 생성되는 전기장의 첨단부가 신장 신경 (119)에 침투하도록 도 1에 나타낸 바와 같이 배열될 수도 있다. 따라서, 본 개시에 따라, 전극 (118)은 신장 신경 (119)에 침투되기를 원하는 전기장의 양에 따라 벌룬 (112)의 외부 표면 (120)상에 위치될 수 있다.
카테터 (110)의 벌룬 (112) 또는 말단부 (114)는 카테터 샤프트 (126)를 밀고 당기는 것에 의해 신장 동맥 (117)과 같은 혈관의 내부를 따라 이동될 수도 있다. 벌룬 (112)은 전극 (118)의 활성화 전에, 또는 전극 (118)의 활성화 동안 혈관의 내부를 따라 이동될 수 있다. 벌룬 (112)은 또한 그것이 완전히 팽창되어 있는 동안, 부분적으로 팽창되어 있는 동안, 또는 수축되어 있는 동안, 혈관의 내부를 따라 이동될 수 있다.
신장 신경의 신경차단 및/또는 이온영동 약물 전달 동안 신장 관류를 유지하기 위하여, 벌룬 (112) 및/또는 카테터, 예컨대 카테터 샤프트 (126)는 벌룬 (112)의 일 측으로부터 다른 측으로 혈액이 흐르는 것을 가능하게 하는 하나 이상의 내강을 포함할 수 있다. 도 3에 나타낸 내강 (128)과 같은 하나 이상의 내강은 신경차단 절차 또는 임의의 다른 원하는 절차를 완료하는 데에 필요한 만큼 오랫동안 벌룬 (112)이 팽창되어 유지되도록 하여 준다. 또한, 이온영동 약물 전달에서의 약물 침투의 깊이는 적용되는 전류의 지속기간에 따라 일부 달라진다.
사용시, 개시되는 카테터 (110)는 인접 조직 (예컨대 혈관 벽, 신경 및 주위 조직) 내에 전위 구배를 생성시키며, 그것은 다시 약물의 이온영동 전달을 촉진한다.
개시되는 이온영동 약물 전달 시스템은 또한 표적 조직에 전달될 1종 이상 약물의 비축분을 포함한다. 바람직하게는, 1종 이상의 약물은 이온 형태로 존재한다. 비제한적으로 예를 들면, 구아네티딘이 노르에피네프린 (노르아드레날린으로도 알려져 있음)의 방출을 억제함으로써 교감 신경의 기능을 감쇠시키는 것으로 알려져 있는 약물이다. 구아네티딘은 +2의 전하를 가지는 이온 형태로 제제화될 수 있다. 추가적으로 또는 다르게는, 다른 약물이 이용될 수도 있다. 비제한적으로 예를 들면, 약물 흡수 속도를 향상시키기 위하여 (예컨대 디메틸 술폭시드 (DMSO)와 같은 침투 또는 투과 강화제), 또는 국소적인 약물 효과를 연장하기 위하여 (예컨대 에피네프린과 같은 맥관벽혈관 수축제(vasovasorum constrictor)), 약물은 1종 이상의 제2 약물과 조합될 수 있다.
일부 실시양태에서, 카테터 (110)는 (예컨대 약물 전달 전에) 약물의 공급원을 포함하며, 신체 내강 및/또는 주위 조직으로의 이온영동 전달을 위한 약물의 방출을 촉진하도록 구성될 수 있다. 일부 실시양태에서, 다른 실시양태에 추가로 또는 그의 대안으로서, 일부 실시양태에서는, 벌룬 (112)의 외부 표면 (120)을 둘러싸는 코팅 (130) (도 1)에 약물이 도입될 수도 있다.
다른 실시양태에 추가로 또는 그의 대안으로서, 도 4에 나타낸 바와 같이, 예컨대 카테터 샤프트 (126)를 통한 약물 공급원으로부터 벌룬 내강 (142)으로의 약물의 투여가 다수의 구멍 (149)을 통해 벌룬 (140)의 내부 공간으로부터 전극(들) (146)에 있거나 그에 인접하여 있는 외부 표면 (144)으로의 약물의 전달을 야기하도록, 이온영동 약물 전달 시스템 (100)의 벌룬 (140)은 천공 (예컨대 점적식 벌룬)될 수 있다. 상기 약물 공급원은 외장되거나 환자의 외부에 있을 수 있다.
도 4에 나타낸 실시양태에서, 카테터 샤프트 (126)는 벌룬 (140)의 내부 표면과 대략 동일한 직경을 가지도록 크기가 설정될 수 있다. 벌룬 (140)의 내부 표면은 샤프트 (126)의 내부 내강 (141)과 유통하는 하나 이상의 개구부(opening)를 포함한다. 상기 하나 이상의 개구부 (명시적으로 나타내지는 않음)를 통하여, 약물은 압력하에 샤프트 (126)를 통해 벌룬 (140)으로 전달된다. 다음에, 약물은 다수의 구멍 (149)으로부터 벌룬 (140)의 외부 표면으로 밀려 나오게 된다. 약물은 카테터 샤프트 (126)가 아닌 다른 내강을 통하여 벌룬 (140)으로 전달될 수도 있다.
다른 실시양태에 추가로 또는 그의 대안으로서, 도 5를 참조하면, 일부 실시양태에서는 벌룬 (150)의 표면상에 배치되며 각각 덮개 층 (152)에 의해 덮여 있는 하나 이상의 웰 (148)에 약물이 저장된다. 상기 덮개 층 (152)이 파열되면, 웰 (148) 내부의 약물은 전극(들) (154) 근처로 방출된다. 상기 덮개 층 (152)은 기계적 작용 (예컨대 혈관 벽에 대하여 가압하는 벌룬에 의해 적용되는 압력), 또는 열의 적용 (예를 들면 전극(들) (154)으로부터의 전기 에너지의 적용을 통한 저항 가열에 의해 금속제 덮개가 용융됨)에 의해 파열될 수 있다.
도 5에서, 저부 2개 웰의 경우, 파열되지 않은 상태로 덮개 층 (152)을 나타낸 반면, 예시 목적으로, 상부 2개 웰의 경우에는, 덮개 층 (152)이 파열되어 있다. 작용시, 모든 덮개 층 (152)은 약물 전달 시스템의 작용 동안 동시에 또는 대략 동시에 파열될 가능성이 있다.
전달될 약물이 전극 (118, 146, 154)에 인접하여 위치하게 되면, 2개 이상의 전극들 사이에 전기장이 적용된다. 약물의 이온 전하는 약물 분자가 전기장을 따름으로써, 예컨대 단순 확산에 의해 이루어지게 되는 것에 비해 더 빠른 속도로 조직에 진입하도록 한다. 조직으로의 약물의 빠른 흡수는 조직의 개방된 일시적 세공에 1회 이상의 고-전압 펄스가 적용되도록 하며 그것은 다시 가속화된 약물 흡수를 촉진하게 되는, 전기천공에 의해 향상될 수 있다. 추가로 또는 다르게는, 이온영동에 사용되는 직류는 펄스형일 수 있는데, 조직 임피던스가 적용된 전류의 주파수에 따라 감소하기 때문이다. 이온 이동의 방향이 적용되는 전기장의 극성에 따라 달라지기 때문에, 전류의 전달은 주로 직류이다. 일부 실시양태에서, 본 개시에 따른 이온영동 카테터는 유리하게도 표적 조직으로부터 원치 않는 화합물, 약물, 및 독소를 제거하는 데에 사용될 수 있다.
상기언급된 실시양태는 벌룬 카테터에 대해 기술하고 있다. 추가로 또는 대안적인 대략 원주형인 혈관 벽 병치의 생성 방법 역시 본 개시의 범주 내에서 구상된다. 비제한적으로 예를 들면, 일부 실시양태에서 전극 (118, 146, 154)은 우산 프레임과 유사한 팽창가능한 와이어 프레임상에 탑재될 수 있다. 일부 실시양태에서, 전극 (118, 146, 154)은 스텐트형(stent-like) 팽창가능한 부재 또는 프레임상에 탑재될 수 있다.
또한 개시되는 것은 신장성 고혈압의 치료 방법이다. 상기 방법은 신장 동맥 (117)의 내강에 도 2에 나타낸 카테터 (110)와 같은 약물-전달 카테터를 위치시키는 단계를 포함한다. 상기 방법은 또한 카테터와 신장 동맥 벽에 인접한 신경 사이에 전위를 생성시키는 단계를 포함한다. 상기 방법은 또한 전위를 통하여 신경에 상기 언급된 약물들과 같은 약물을 투여함으로써 신경의 활성을 감쇠시키는 단계를 포함한다.
또한 개시되는 것은 고혈압 환자가 신장 신경차단 절차로부터 이익을 얻을 가능성이 있는지 여부의 확인 방법이다. 그것은 교감 신경 기능을 억제할 수 있는 알려져 있는 구아네티딘의 특성을 바탕으로 한다. 상기 방법은 (1) 환자의 혈압을 측정하는 단계; (2) 환자에게 예를 들면, 경구 정제, 주사 또는 정맥내 전달에 의해 구아네티딘을 투여하는 단계; (3) 구아네티딘 투여 후 환자 혈압의 변화를 측정하는 단계; (4) 혈압의 변화를 예정된 값과 비교하는 단계; 및 (5) 혈압의 변화가 예정된 값을 초과하는 경우, 신장 신경차단 절차를 수행하는 단계를 포함한다.
본 개시에 따른 약물 전달 시스템 및 카테터는 적어도 하기의 장점들을 가진다: (1) 열이 생성되지 않으며, 그에 따라 환자가 고통을 경험하지 않음; (2) 흐름을 제한하는 협착을 발생시키지 않음; (3) 치료가 원주형이며, 그에 따라 신장 신경의 치료를 보장하는 데에 1회의 적용만이 필요함; 및 (4) 시스템과 카테터가 치료 동안 혈관 벽과 병치를 유지함.
본 개시의 기술된 실시양태들은 제한이 아니라 예시를 위한 것으로써, 본 개시의 모든 실시양태를 나타내고자 한 것은 아니다. 법적으로 글자 그대로 및 등가로 인식되는 것 모두인 본원 및/또는 하기 청구범위에 제시되어 있는 바와 같은 본 개시의 사상 또는 범주에서 벗어나지 않고도, 상기-개시된 실시양태들의 추가적인 변형, 및 다른 특징 및 기능들, 또는 그의 대안이 이루어질 수 있거나, 또는 많은 다른 상이한 시스템 또는 적용분야로 바람직하게 조합될 수 있다.

Claims (30)

  1. 에너지 공급원;
    카테터;
    카테터의 말단부에 배치되는 벌룬;
    벌룬 표면상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및
    벌룬과 작용적으로 연결되는 약물 공급원
    을 포함하는, 이온영동 약물 전달 시스템.
  2. 제1항에 있어서, 약물 공급원이 약물을 선택적으로 방출하도록 구성되는, 이온영동 약물 전달 시스템.
  3. 제1항에 있어서, 약물 공급원이 1종 이상의 약물을 포함하는, 이온영동 약물 전달 시스템.
  4. 제3항에 있어서, 1종 이상의 약물이 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택되는, 이온영동 약물 전달 시스템.
  5. 제1항에 있어서, 에너지 공급원이 하나 이상의 전극에 직류를 전달하도록 구성되는, 이온영동 약물 전달 시스템.
  6. 제1항에 있어서, 벌룬의 외부 표면이 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함하는, 이온영동 약물 전달 시스템.
  7. 제6항에 있어서, 하나 이상의 웰이, 파열되도록 구성되는 덮개 층을 포함하는, 이온영동 약물 전달 시스템.
  8. 제1항에 있어서, 벌룬이 벌룬의 내부와 유통하는 다수의 구멍을 포함하는, 이온영동 약물 전달 시스템.
  9. 제1항에 있어서, 약물 공급원이 벌룬의 외부 표면상에 제공되는 코팅인, 이온영동 약물 전달 시스템.
  10. 에너지 공급원;
    카테터;
    카테터의 말단부에 배치되는 팽창가능한 부재;
    팽창가능한 부재상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및
    팽창가능한 부재와 작용적으로 연결되는 약물 공급원
    을 포함하는, 이온영동 약물 전달 시스템.
  11. 제10항에 있어서, 약물 공급원이 약물을 선택적으로 방출하도록 구성되는, 이온영동 약물 전달 시스템.
  12. 제10항에 있어서, 약물 공급원이 1종 이상의 약물을 포함하는, 이온영동 약물 전달 시스템.
  13. 제12항에 있어서, 1종 이상의 약물이 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택되는, 이온영동 약물 전달 시스템.
  14. 제10항에 있어서, 에너지 공급원이 하나 이상의 전극에 직류를 전달하도록 구성되는, 이온영동 약물 전달 시스템.
  15. 제10항에 있어서, 팽창가능한 부재가 벌룬 및 프레임으로 구성되는 군에서 선택되는, 이온영동 약물 전달 시스템.
  16. 제15항에 있어서, 벌룬의 외부 표면이 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함하는, 이온영동 약물 전달 시스템.
  17. 제16항에 있어서, 하나 이상의 웰이, 파열되도록 구성되는 덮개 층을 포함하는, 이온영동 약물 전달 시스템.
  18. 제15항에 있어서, 벌룬이 벌룬의 내부와 유통하는 다수의 구멍을 포함하는, 이온영동 약물 전달 시스템.
  19. 제15항에 있어서, 약물 공급원이 벌룬의 외부 표면상에 제공되는 코팅인, 이온영동 약물 전달 시스템.
  20. 카테터의 말단부에 배치되는 벌룬;
    벌룬 표면상에 배치되며 에너지 공급원에 작용가능하게 연결되는 하나 이상의 전극; 및
    벌룬과 작용적으로 연결되는 약물 공급원
    을 포함하는, 이온영동 약물 전달 카테터.
  21. 제20항에 있어서, 약물 공급원이 약물을 선택적으로 방출하도록 구성되는, 이온영동 약물 전달 카테터.
  22. 제20항에 있어서, 약물 공급원이 1종 이상의 약물을 포함하는, 이온영동 약물 전달 카테터.
  23. 제22항에 있어서, 1종 이상의 약물이 구아네티딘, 에피네프린, 디메틸 술폭시드 (DMSO) 및 이들의 조합으로 구성되는 군에서 선택되는, 이온영동 약물 전달 카테터.
  24. 제20항에 있어서, 벌룬의 외부 표면이 약물 공급원을 저장하기 위한 하나 이상의 웰을 포함하는, 이온영동 약물 전달 카테터.
  25. 제24항에 있어서, 하나 이상의 웰이, 파열되도록 구성되는 덮개 층을 포함하는, 이온영동 약물 전달 카테터.
  26. 제20항에 있어서, 벌룬이 벌룬의 내부와 유통하는 다수의 구멍을 포함하는, 이온영동 약물 전달 카테터.
  27. 제20항에 있어서, 약물 공급원이 벌룬의 외부 표면상에 제공되는 코팅인, 이온영동 약물 전달 카테터.
  28. 신장 동맥의 내강에 약물-전달 카테터를 위치시키는 단계;
    카테터와 신장 동맥 벽에 인접한 신경 사이에 전위를 생성시키는 단계; 및
    상기 전위를 통하여 상기 신경에 약물을 투여하여 상기 신경의 활성을 감쇠시키는 단계
    를 포함하는, 신장성 고혈압의 치료 방법.
  29. 고혈압 환자의 혈압을 측정하는 단계;
    고혈압 환자에게 구아네티딘을 투여하는 단계;
    구아네티딘 투여 후 고혈압 환자의 혈압이 변화하는지를 확인하는 단계;
    혈압의 변화를 예정된 값과 비교하는 단계; 및
    혈압의 변화가 예정된 값을 초과하는 경우, 고혈압 환자에서 신장 신경차단 절차를 수행하는 단계
    를 포함하는, 고혈압 환자가 신장 신경차단 절차로부터 이익을 얻을 수 있는지 여부의 확인 방법.
  30. 신장 동맥의 내강에 약물 전달 카테터를 위치시키는 단계;
    카테터와 신장 동맥 벽에 인접한 신경 사이에 전위를 생성시키는 단계; 및
    전위를 통하여 신경에 약물을 투여하여 신경의 활성을 감쇠시키는 단계
    를 포함하는, 고혈압의 치료 방법.
KR1020137026368A 2011-04-08 2012-04-09 신장 교감 신경의 신경차단 및 이온영동 약물 전달을 위한 이온영동 약물 전달 시스템 및 방법 KR20130131471A (ko)

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US20150231386A1 (en) 2015-08-20
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