JPWO2020205547A5 - - Google Patents
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- JPWO2020205547A5 JPWO2020205547A5 JP2021560405A JP2021560405A JPWO2020205547A5 JP WO2020205547 A5 JPWO2020205547 A5 JP WO2020205547A5 JP 2021560405 A JP2021560405 A JP 2021560405A JP 2021560405 A JP2021560405 A JP 2021560405A JP WO2020205547 A5 JPWO2020205547 A5 JP WO2020205547A5
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- cardioprotective
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第6の例示的態様では、心臓を処置する方法が、心臓を補助するために機械的循環補助デバイスを作動させることを含む。方法は、機械的循環補助デバイスを補助期間の間作動させること、少なくとも1つの心血管を閉鎖すること、および閉鎖された心血管に生物学的療法を施すことをさらに含む。生物学的療法は、筋細胞、線維芽細胞、内皮細胞、またはその他の標的組織を優先的に標的とするようにしてもよい。
[本発明1001]
補助期間の間、機械的循環補助デバイスを作動させる段階、
該補助期間の間に、血管を閉鎖する段階、および
該補助期間の間に、生物学的療法を心臓に施す段階
を含む、心臓を処置する方法。
[本発明1002]
前記機械的循環補助デバイスが、少なくとも2.5 L/分の血流、少なくとも3.5 L/分の血流、または少なくとも5 L/分の血流のうちの1つの速度で作動する、本発明1001の方法。
[本発明1003]
前記生物学的療法が、閉鎖された血管内に施される、本発明1001または本発明1002の方法。
[本発明1004]
血管形成術用バルーンを血管に挿入する段階、および
該血管を一時的に閉鎖するために、該血管形成術用バルーンを膨張させる段階
をさらに含む、本発明1003の方法。
[本発明1005]
前記生物学的療法を心臓に施す段階が、
前記生物学的療法を、患者の血管内の血管形成術用バルーンよりも遠位の場所に施すこと
を含む、本発明1004の方法。
[本発明1006]
前記患者の血管が冠動脈であり、かつ前記生物学的療法が、該冠動脈内の膨張した血管形成術用バルーンの下流で施される、本発明1005の方法。
[本発明1007]
生物学的療法を心臓に施す段階が、
第1の施す期間の間に、生物学的療法の第1の用量を該心臓に施すこと、
第1の休止期間をおくこと、および
第2の施す期間の間に、生物学的療法の第2の用量を該心臓に施すこと
を含む、本発明1004、1005、または1006の方法。
[本発明1008]
前記生物学的療法を施すことが、前記生物学的療法を血管内に注射することを含む、本発明1007の方法。
[本発明1009]
膨張した血管形成術用バルーンが、前記血管を約3分未満閉鎖する、本発明1004の方法。
[本発明1010]
膨張した血管形成術用バルーンが、前記血管を約1分未満閉鎖する、本発明1004の方法。
[本発明1011]
前記補助期間が、10分超、15分超、20分超、または30分超のうちの1つである、前記本発明のいずれかの方法。
[本発明1012]
前記生物学的療法の持続時間が、10秒未満、30秒未満、1分未満、3分未満、または5分未満のうちの1つである、前記本発明のいずれかの方法。
[本発明1013]
第1の休止期間が、第1の施す期間よりも長い、本発明1007の方法。
[本発明1014]
第1の施す期間が、第2の施す期間よりも長い、本発明1007の方法。
[本発明1015]
前記機械的循環補助デバイスが、第1の施す期間、第1の休止期間、および第2の施す期間の間、作動する、本発明1007の方法。
[本発明1016]
前記機械的循環補助デバイスが、血液ポンプを含む、本発明1001の方法。
[本発明1017]
前記血液ポンプが、マイクロアキシャル（microaxial）血液ポンプである、本発明1016の方法。
[本発明1018]
前記生物学的療法を施す段階が、前記生物学的療法を、冠血管、心筋、線維芽細胞、または内皮細胞のうちの1つへと注射することを含む、本発明1001の方法。
[本発明1019]
前記機械的循環補助デバイスが、少なくとも2.5 L/分の血流、少なくとも3.5 L/分の血流、または少なくとも5 L/分の血流のうちの1つの速度で作動する、本発明1001の方法。
[本発明1020]
前記生物学的療法が、遺伝子療法ベクターである、前記本発明のいずれかの方法。
[本発明1021]
前記遺伝子療法ベクターを心臓に施すことが、心組織におけるベクターDNAの発現を増加させるように構成されている、本発明1020の方法。
[本発明1022]
患者内に血液ポンプを経皮的に挿入し、かつ該血液ポンプを、該患者の心臓の大動脈弁にわたって配置する段階、
該患者の心臓の左心室の負荷を軽減するために、該血液ポンプを作動させる段階、
該患者の心臓の血管を閉鎖する段階、および
該血液ポンプを作動させかつ該血管を閉鎖するのと同時に、生物学的療法を該患者の冠血管内に注射する段階
を含む、患者の心臓を補助する方法。
[本発明1023]
前記血管が、
患者の冠動脈内にバルーンを設置すること、および
該バルーンを、第1の期間の間、膨張させて、第1の期間の間、該冠動脈内の血流をブロックすること
により閉鎖される、本発明1022の方法。
[本発明1024]
前記生物学的療法が、遺伝子療法ベクターである、本発明1022または1023の方法。
[本発明1025]
患者の冠動脈内にバルーンを設置する段階、
該バルーンを、第1の期間の間、膨張させて、第1の期間の間、該冠動脈内の血流を一時的にブロックする段階、
該患者の心臓内に血液ポンプを設置し、かつ該血液ポンプを、該心臓の大動脈弁にわたって配置する段階、
第2の期間の間、該患者の心臓内で該血液ポンプを作動させる段階、および
第1の期間の間に、該冠動脈内の膨張したバルーンよりも遠位の場所に遺伝子療法ベクターを注射する段階、および
第1の期間の後にバルーンをしぼませて該冠動脈内の血流を復活させる段階
を含む、患者の心筋における遺伝子発現を上方制御する方法であって、
第1の期間が第2の期間内に存在し、かつ第1の期間は、該患者の心筋の細胞に永続的虚血をもたらさない持続時間を有する、
方法。
[本発明1026]
第2の期間の間に、前記冠動脈内の膨張したバルーンよりも遠位の場所に前記遺伝子療法ベクターを注射する段階をさらに含む、本発明1025の方法。
[本発明1027]
第3の期間の間に、前記冠動脈内の膨張したバルーンよりも遠位の場所に前記遺伝子療法ベクターを注射する段階をさらに含み、
第3の期間は、第2の期間よりも短い、または第2の期間と等しい、
本発明1026の方法。
[本発明1028]
第1の期間の持続時間が3分未満である、本発明1025の方法。
[本発明1029]
第1の期間の持続時間が1分未満である、本発明1028の方法。
[本発明1030]
第1の期間の持続時間が30秒未満である、本発明1029の方法。
[本発明1031]
機械的循環補助デバイス；
近位端および遠位端を有する膨張可能なバルーンと、膨張カテーテルとを有する、バルーンカテーテルであって、該膨張カテーテルは、該バルーンカテーテルのバルーンの近位端と流体連通しており、該バルーンは、該機械的循環補助デバイスとの同時使用のために患者の冠動脈に挿入されるように構成されている、バルーンカテーテル；
生物学的療法をインビボで送達するための送達カテーテルであって、該生物学的療法を含有する溶液を受けるように構成されている入口開口部を有する近位端、出口開口部を有する遠位端、および該送達カテーテルの近位端と遠位端との間に延びるチューブを有する、送達カテーテル
を含む、心保護システムであって
該バルーンは、膨張した場合に、該冠動脈を通る血流を少なくとも部分的に閉鎖するように構成されている、
心保護システム。
[本発明1032]
前記機械的循環補助デバイスが、カテーテルベースの血管内血液ポンプである、本発明1031の心保護システム。
[本発明1033]
送達カテーテルの遠位端の出口開口部が、膨張可能なバルーンカテーテルのバルーンが膨張した場合に、該バルーンカテーテルの遠位端よりも遠位に位置するように構成されている、本発明1031の心保護システム。
[本発明1034]
送達カテーテルの近位端と遠位端との間に延びるチューブが、前記バルーンよりも長い長手方向長さを有する、本発明1031の心保護システム。
[本発明1035]
バルーンカテーテルが、バルーン膨張の際に該バルーンで送達カテーテルの出口開口部を塞がないように構成されている、本発明1031の心保護システム。
[本発明1036]
前記生物学的療法が、遺伝子療法ベクターである、本発明1031～1035のいずれかの心保護システム。
[本発明1037]
前記遺伝子療法ベクターが、インビボで発現すると心保護機能を有するペプチドをコードする非天然核酸物質を含み、前記遺伝子療法ベクターは、心筋細胞に吸収されるように構成されている、本発明1036の心保護システム。
[本発明1038]
血管を閉鎖する一方で機械的循環補助デバイスを作動させることと、
閉鎖の間に、患者の心臓内に遺伝子療法ベクターを投与し、かつ、以下の段階：
（i）該患者の心臓からの前記遺伝子療法ベクターのクリアランス速度を低下させる段階、
（ii）該患者の心臓内での前記遺伝子療法ベクターの発現をもたらす段階、および
（iii）前記遺伝子療法ベクターによる該患者の心臓への形質導入をもたらす段階
の少なくとも1つを行うことと
を含む、患者の心臓を補助する方法。
[本発明1039]
前記血管を閉鎖するのにバルーンカテーテルが用いられる、本発明1038の方法。
In a sixth exemplary embodiment, a method of treating a heart includes operating a mechanical circulatory assist device to assist the heart. The method further includes activating the mechanical circulatory support device for a period of support, occluding at least one cardiovascular vessel, and administering biological therapy to the occluded cardiovascular vessel. Biological therapy may preferentially target muscle cells, fibroblasts, endothelial cells, or other target tissues.
[Invention 1001]
activating the mechanical circulatory assist device for the assist period;
closing the blood vessel during the assistance period; and
administering biologic therapy to the heart during the assistance period
A method of treating a heart, comprising:
[Invention 1002]
1002. The method of Invention 1001, wherein said mechanical circulatory support device operates at a rate of one of at least 2.5 L/min blood flow, at least 3.5 L/min blood flow, or at least 5 L/min blood flow. .
[Invention 1003]
The method of invention 1001 or invention 1002, wherein said biological therapy is administered intravascularly.
[Invention 1004]
inserting an angioplasty balloon into a blood vessel; and
inflating the angioplasty balloon to temporarily occlude the vessel;
The method of the invention 1003, further comprising:
[Invention 1005]
administering the biologic therapy to the heart comprises:
administering the biological therapy at a location distal to the angioplasty balloon within the patient's vessel
The method of the invention 1004, comprising:
[Invention 1006]
1006. The method of invention 1005, wherein said patient's vessel is a coronary artery and said biological therapy is administered downstream of an inflated angioplasty balloon within said coronary artery.
[Invention 1007]
administering the biologic therapy to the heart comprises:
administering a first dose of biological therapy to the heart during the first administration period;
allowing a first rest period, and
administering a second dose of biological therapy to the heart during the second administration period
The method of the invention 1004, 1005, or 1006, comprising:
[Invention 1008]
1007. The method of the present invention 1007, wherein administering said biological therapy comprises injecting said biological therapy intravascularly.
[Invention 1009]
1005. The method of invention 1004, wherein the inflated angioplasty balloon occludes said vessel for less than about 3 minutes.
[Invention 1010]
1005. The method of invention 1004, wherein the inflated angioplasty balloon occludes said blood vessel for less than about 1 minute.
[Invention 1011]
The method of any of the preceding inventions, wherein the duration of assistance is one of greater than 10 minutes, greater than 15 minutes, greater than 20 minutes, or greater than 30 minutes.
[Invention 1012]
The method of any of the preceding inventions, wherein the duration of the biological therapy is one of less than 10 seconds, less than 30 seconds, less than 1 minute, less than 3 minutes, or less than 5 minutes.
[Invention 1013]
The method of the invention 1007, wherein the first resting period is longer than the first applying period.
[Invention 1014]
The method of invention 1007, wherein the first period of application is longer than the second period of application.
[Invention 1015]
1008. The method of the present invention 1007, wherein said mechanical circulatory assist device operates during a first administering period, a first resting period, and a second administering period.
[Invention 1016]
1002. The method of invention 1001, wherein said mechanical circulatory assist device comprises a blood pump.
[Invention 1017]
1016. The method of the invention 1016, wherein said blood pump is a microaxial blood pump.
[Invention 1018]
1002. The method of Invention 1001, wherein administering said biological therapy comprises injecting said biological therapy into one of coronary vessels, myocardium, fibroblasts, or endothelial cells.
[Invention 1019]
1002. The method of Invention 1001, wherein said mechanical circulatory support device operates at a rate of one of at least 2.5 L/min blood flow, at least 3.5 L/min blood flow, or at least 5 L/min blood flow. .
[Invention 1020]
The method of any of the preceding inventions, wherein said biological therapy is a gene therapy vector.
[Invention 1021]
1021. The method of invention 1020, wherein administering said gene therapy vector to the heart is configured to increase expression of vector DNA in cardiac tissue.
[Invention 1022]
percutaneously inserting a blood pump into a patient and placing the blood pump across the aortic valve of the patient's heart;
activating the blood pump to unload the left ventricle of the patient's heart;
closing blood vessels of the patient's heart; and
injecting a biologic therapy into the patient's coronary vessels at the same time as activating the blood pump and occluding the vessel;
A method of assisting a patient's heart, comprising:
[Invention 1023]
the blood vessel
placing the balloon in the patient's coronary artery; and
inflating the balloon for a first period of time to block blood flow in the coronary artery for a first period of time
The method of the present invention 1022 closed by.
[Invention 1024]
The method of invention 1022 or 1023, wherein said biological therapy is a gene therapy vector.
[Invention 1025]
placing the balloon in the patient's coronary artery;
inflating the balloon for a first period of time to temporarily block blood flow in the coronary artery for a first period of time;
placing a blood pump in the patient's heart and placing the blood pump across the aortic valve of the heart;
operating the blood pump within the patient's heart for a second period of time; and
injecting a gene therapy vector at a location distal to the inflated balloon within the coronary artery during the first period; and
Deflating the balloon after the first period to restore blood flow in the coronary artery.
A method of upregulating gene expression in a patient's myocardium comprising
the first period of time is within the second period of time, and the first period of time has a duration that does not result in permanent ischemia in cells of the patient's myocardium;
Method.
[Invention 1026]
1026. The method of invention 1025, further comprising injecting said gene therapy vector at a location distal to said inflated balloon within said coronary artery during a second period of time.
[Invention 1027]
further comprising injecting the gene therapy vector at a location distal to the inflated balloon within the coronary artery during a third period of time;
the third period is less than or equal to the second period,
The method of the invention 1026.
[Invention 1028]
The method of invention 1025, wherein the duration of the first time period is less than 3 minutes.
[Invention 1029]
The method of invention 1028, wherein the duration of the first time period is less than 1 minute.
[Invention 1030]
The method of invention 1029, wherein the duration of the first time period is less than 30 seconds.
[Invention 1031]
mechanical circulatory support devices;
A balloon catheter having an inflatable balloon having proximal and distal ends and a dilatation catheter, the dilatation catheter being in fluid communication with a proximal end of the balloon of the balloon catheter, the balloon is a balloon catheter configured to be inserted into a patient's coronary artery for simultaneous use with said mechanical circulatory support device;
A delivery catheter for delivering a biological therapy in vivo, the proximal end having an inlet opening configured to receive a solution containing the biological therapy, the distal end having an outlet opening. A delivery catheter having an end and a tube extending between proximal and distal ends of the delivery catheter.
A cardioprotective system comprising
the balloon is configured to at least partially occlude blood flow through the coronary artery when inflated;
cardioprotective system.
[Invention 1032]
The cardioprotective system of Invention 1031, wherein said mechanical circulatory support device is a catheter-based intravascular blood pump.
[Invention 1033]
1031 of Invention 1031, wherein the exit opening in the distal end of the delivery catheter is configured to be distal to the distal end of the inflatable balloon catheter when the balloon of the inflatable balloon catheter is inflated. cardioprotective system.
[Invention 1034]
1031. The cardioprotective system of Invention 1031, wherein a tube extending between the proximal and distal ends of the delivery catheter has a longitudinal length greater than the balloon.
[Invention 1035]
1031. The cardioprotection system of Invention 1031, wherein the balloon catheter is configured such that the balloon does not occlude the exit opening of the delivery catheter upon balloon inflation.
[Invention 1036]
The cardioprotective system of any of inventions 1031-1035, wherein said biological therapy is a gene therapy vector.
[Invention 1037]
1036. The heart of Invention 1036, wherein said gene therapy vector comprises a non-naturally occurring nucleic acid agent encoding a peptide having cardioprotective function when expressed in vivo, said gene therapy vector configured to be taken up by myocardial cells. protection system.
[Invention 1038]
activating a mechanical circulatory assist device while occluding a blood vessel;
Administering a gene therapy vector into the patient's heart during closure and following steps:
(i) reducing the rate of clearance of said gene therapy vector from said patient's heart;
(ii) effecting expression of said gene therapy vector in said patient's heart; and
(iii) effecting transduction of the patient's heart with said gene therapy vector;
doing at least one of
A method of assisting a patient's heart, comprising:
[Invention 1039]
1038. The method of invention 1038, wherein a balloon catheter is used to occlude said blood vessel.
Claims (7)
近位端および遠位端を有する膨張可能なバルーンと、膨張カテーテルとを有する、バルーンカテーテルであって、該膨張カテーテルは、該バルーンカテーテルのバルーンの近位端と流体連通しており、該バルーンは、該機械的循環補助デバイスとの同時使用のために患者の冠動脈に挿入されるように構成されている、バルーンカテーテル；
生物学的療法をインビボで送達するための送達カテーテルであって、該生物学的療法を含有する溶液を受けるように構成されている入口開口部を有する近位端、出口開口部を有する遠位端、および該送達カテーテルの近位端と遠位端との間に延びるチューブを有する、送達カテーテル
を含む、心保護システムであって
該バルーンは、膨張した場合に、該冠動脈を通る血流を少なくとも部分的に閉鎖するように構成されている、
心保護システム。 mechanical circulatory support devices;
A balloon catheter having an inflatable balloon having proximal and distal ends and a dilatation catheter, the dilatation catheter being in fluid communication with a proximal end of the balloon of the balloon catheter, the balloon is a balloon catheter configured to be inserted into a patient's coronary artery for simultaneous use with said mechanical circulatory support device;
A delivery catheter for delivering a biological therapy in vivo, the proximal end having an inlet opening configured to receive a solution containing the biological therapy, the distal end having an outlet opening. A cardioprotection system comprising a delivery catheter having an end and a tube extending between a proximal end and a distal end of the delivery catheter, the balloon, when inflated, restricts blood flow through the coronary arteries. configured to at least partially close,
cardioprotective system.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962826444P | 2019-03-29 | 2019-03-29 | |
| US62/826,444 | 2019-03-29 | ||
| US202062959333P | 2020-01-10 | 2020-01-10 | |
| US62/959,333 | 2020-01-10 | ||
| PCT/US2020/025307 WO2020205547A1 (en) | 2019-03-29 | 2020-03-27 | Systems and methods for left ventricular unloading in biologic therapy or vectored gene therapy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022528197A JP2022528197A (en) | 2022-06-08 |
| JPWO2020205547A5 true JPWO2020205547A5 (en) | 2023-03-31 |
Family
ID=70465277
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021560405A Pending JP2022528197A (en) | 2019-03-29 | 2020-03-27 | Systems and methods for reducing left ventricular load in biological or vector gene therapy |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20200305888A1 (en) |
| EP (1) | EP3946505A1 (en) |
| JP (1) | JP2022528197A (en) |
| KR (1) | KR20220007043A (en) |
| CN (1) | CN113710282A (en) |
| AU (1) | AU2020256102A1 (en) |
| CA (1) | CA3131428A1 (en) |
| IL (1) | IL286675A (en) |
| SG (1) | SG11202110360TA (en) |
| WO (1) | WO2020205547A1 (en) |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6152141A (en) * | 1994-07-28 | 2000-11-28 | Heartport, Inc. | Method for delivery of therapeutic agents to the heart |
| US5797870A (en) * | 1995-06-07 | 1998-08-25 | Indiana University Foundation | Pericardial delivery of therapeutic and diagnostic agents |
| US6673039B1 (en) * | 1997-12-19 | 2004-01-06 | Trustees Of The University Of Pennsylvania | Compositions, kits, methods, and apparatus for transvascular delivery of a composition to an extravascular tissue of a mammal |
| US6800068B1 (en) * | 2001-10-26 | 2004-10-05 | Radiant Medical, Inc. | Intra-aortic balloon counterpulsation with concurrent hypothermia |
| DE602004003266D1 (en) * | 2003-02-07 | 2007-01-04 | Pierpont Family Ltd Partnershi | Catheter system for angioplasty |
| WO2005027995A2 (en) * | 2003-09-19 | 2005-03-31 | The Trustees Of The University Of Pennsylvania | Global myocardial perfusion catheter |
| US8162880B2 (en) * | 2008-01-18 | 2012-04-24 | Swaminathan Jayaraman | Delivery of therapeutic and marking substance through intra lumen expansion of a delivery device |
| US8721517B2 (en) * | 2012-05-14 | 2014-05-13 | Thoratec Corporation | Impeller for catheter pump |
| WO2017083750A1 (en) * | 2015-11-11 | 2017-05-18 | Intrexon Corporation | Compositions and methods for expression of multiple biologically active polypeptides from a single vector for treatment of cardiac conditions and other pathologies |
| KR20200108328A (en) * | 2018-01-10 | 2020-09-17 | 터프츠 메디컬 센터, 인크 | Left ventricle unloading system and method for myocardial infarction treatment |
-
2020
- 2020-03-27 CN CN202080025027.XA patent/CN113710282A/en active Pending
- 2020-03-27 WO PCT/US2020/025307 patent/WO2020205547A1/en unknown
- 2020-03-27 KR KR1020217034524A patent/KR20220007043A/en unknown
- 2020-03-27 SG SG11202110360TA patent/SG11202110360TA/en unknown
- 2020-03-27 CA CA3131428A patent/CA3131428A1/en active Pending
- 2020-03-27 EP EP20721902.3A patent/EP3946505A1/en active Pending
- 2020-03-27 AU AU2020256102A patent/AU2020256102A1/en active Pending
- 2020-03-27 US US16/832,924 patent/US20200305888A1/en active Pending
- 2020-03-27 JP JP2021560405A patent/JP2022528197A/en active Pending
-
2021
- 2021-09-26 IL IL286675A patent/IL286675A/en unknown
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