CN1171055A - 粒料输送 - Google Patents
粒料输送 Download PDFInfo
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- CN1171055A CN1171055A CN95197014A CN95197014A CN1171055A CN 1171055 A CN1171055 A CN 1171055A CN 95197014 A CN95197014 A CN 95197014A CN 95197014 A CN95197014 A CN 95197014A CN 1171055 A CN1171055 A CN 1171055A
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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
- 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
- A61M5/178—Syringes
- A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
- A61M5/3015—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow
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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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
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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
- 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
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
Abstract
无针头注射器,它包括:有内腔的体部,内腔的上游端是与同一或是经布置成与同一可突然喷射到此内腔中的气压源通连,内腔的下游端则终止于一双稳态的膜盒之后,此膜盒可在它使上述体部具有在外部的用于包含药剂微粒的凹腔的倒转位置和一外翻的外凸位置之间运动;这样的布置形式在使用中能在气体于压力下射到前述内腔中时,使膜盒从其倒转位置迅速地变换到外翻位置,而将药剂微粒向外弹出。
Description
在申请人先前的WO94/24263号专利中,公开了一种涉及使用无针头注射器的无侵袭性药物输送系统,它把药剂微粒依控制的剂量例如通过未受损的皮肤射到身体组织内,或是将遗传物质输入活细胞内。在上述的先前的专利申请文件中所述的注射器取细长的管状喷嘴形式,在此喷嘴上游端附近有一个破碎的薄膜在初始时封闭着通过此喷嘴的通道,药剂位于此薄膜邻近,同时有激励装置用来给此薄膜的上游侧施加一气体压力,其大小足以破坏薄膜,同时产生出其中夹裹有上述药剂微粒的通过喷嘴的超声气流。
正如该先前的专利说明书中所说明的,所述的药剂微粒可以是例如以遗传物质涂层的载体粒子,或可以是用于各种治疗用途的粉末药物。类似地,所述先前的说明书还说明了下述参数;粒度(最好为10~40μm);密度(最好为0.5~2.0g/cm3);速度(最好为200~2500m/sec),动量密度(最好为4~7kg/sec/m),业已证明,上述参数适合用来突入目标。这些参数固然是不变的,但现在我们已对微粒的输送系统作出了改进。
根据本发明制成的无针头注射器包括:有内腔的体部,内腔的上游端是与同一或是经布置成与同一可突然喷射到此内腔中的气压源通连,内腔的下游端则终止于双稳态的膜盒之后,此膜盒则可在它使上述体部具有在外部的包含药剂微粒的凹腔倒转位置和一外翻的外凸位置之间运动,这样的布置形式在使用中能在气体于压力下射到前述内腔中时,让膜盒从其倒转位置迅速地变换到外翻位置,而将药剂微粒向外弹出。
上述新颖的结构的优点是,即是使像通常情况那样需用气体或超声振荡波来迅速将膜盒从其倒转位置变换到外翻位置,此膜盒也将包含前述内腔中的气体;从而不需用任何装置来耗散或消除从目标反射回的种种振荡波。此外,作为施药目标的身体组织也不会受到此高速气流的任何损害。
正如先前说明书中所公开的,可以这样地来释出加压气体,即在可破碎的薄膜之后蓄积压力,直至此薄膜两侧的压力差足以弄破薄膜而使压力突然射入前述内腔中。或者,也可使这种注射器安装上一个带阀的压缩气体贮槽,此阀可以突然打开将气体注入该内腔中。在以上两种情形下,要是所述气体比空气轻,例如是氦气,则振荡波的速度会加大。如果该内腔原先也充有轻于空气的气体,例如氦气,则可以增强上述效应。
为了避免在输送之前损失药剂微粒,同时为了保持此药剂微粒的无菌性,前述的凹腔最好由例如可回撤屏蔽件或能在喷射时为药粒易于穿透的薄护膜覆盖。
这样的注射器可以构造成用来超越皮肤将药物投入体内,这时的注射器体部内腔可以由通过一管状喷嘴的通道提供,而膜盒则可设在喷嘴下游端的邻近并大致面对喷嘴的轴向。或者可使本发明与导管例如与动脉导管结合使用,这时的膜盒可以设在此导管体部的侧壁上,使得在外翻时,药剂微粒能相对于该体部沿侧向推进。这有可能用于治疗血管增厚疾病,将遗传物质输送到已扩张的变窄了的血管外壁上,用遗传工程方法使贴衬于血管壁上的内皮细胞变形,用以防止血管再变窄/再堵塞。
此外,开发以导管为基础的输药系统还可以有其它用途,用来局部地投送组合成的化合物(例如用于化疗)到特定的内部器官,以及用于局部的器官基的激素置换。这种导管装置也可用来将药物或DNA(脱氧核糖核酸)投放到可够到的用于治疗目的的表面(例如用于治疗呼吸道、肠胃道或生殖-尿道等等的粘膜表面的肿瘤)。
下面通过附图以举例方式说明本发明。
图1至图3示明用来超越皮肤输送药剂微粒的注射器。例如图1具体所示,这种注射器有一圆筒形的储槽10,初始时在约80bar的压力下含有氦。槽10拧合到包括一易破碎室12的第一管状体部11上并与之隔绝。体部11拧合到含有通道14的第二管状体部13上并与之隔绝。体部13则再拧合到包含通道18的第三管状体部17上并与之隔绝,而此体部17的底上还拧合有管状梢部19。
在上述结构下,贮槽10可以独立地存放并可在紧接使用之前再装配到注射器的其余部分上,体部11与13是相分开的,允许在其间夹设一可破碎的薄膜20。梢部19也可与体部17分开,允许在其间夹设一可倒转的双稳态膜盒21,膜盒21取拱形,由刚性结实但有弹性的材料例如聚酯薄膜在适当的模具中热成形。体部13与17可以分开,以便部件17、19与21可以作为一次性单元件设置。
治疗用药剂微粒最初设置于膜盒21向外的表面上。这些微粒可以由静电力、由它们天然的粘性或是通过蒸发悬浮它们的乙醇使其附着。但是,为了无菌,膜盒21最好加盖并在其边缘处相对于弱的护膜22密封,而形成包含药剂微粒的密封容器,如图3所示。此弱的护膜22可以在其上切划以使其易于破碎而致将薄膜弄碎。
使用时,将注射器组装好,并在近似大气压力下使内腔14、18预先以氦充填,使梢部邻近于或触及待治疗的皮肤,在下柱塞24而将阀25打开,让氦气排入易破碎室12中。阀25最好布置成使柱塞24的前部区域在圆筒形贮槽10出口的下游处大于此柱塞上游的前部区,这样就能形成一种自开(速开)阀。当室12中的压力达到充分大的值例如约23bar时,薄膜20就破裂,释放出的振荡波则通过通道14与18所形成的内腔即喷嘴,促成膜盒21突然外翻成向下和朝外的凸形。这就迫使微粒药物在挡膜22破裂的同时迅速自注射器推出。
如图3所示,可以设置一短管式隔件26来降低药剂微粒在碰撞前的速度同时使药剂微粒能分布得更广,以加大皮肤的目标区。
图4至7说明本发明对用于治疗血管增厚疾病的动脉导管上的应用。
图5表明了此导管的整体,在其上游端设有贮槽10、阀25、易破碎室12和可破碎膜20,这些都与第一例中的类似。此导管可以是三内腔导管,一个内腔用于通常的导引线,第二个用于载运气体使定位的气囊27充气,以使导管前端(示明于图4中)相邻处的体部28推压向动脉29的壁部,第三个内腔30则用来将振荡波传送至导管的梢端。
在导管体部28侧壁中的孔口31处设有双稳态膜盒32。在图4中所示的和在图6中以实线所示的位置处,此膜盒给出一沿侧向面朝外的凹腔,其中有药剂微粒,例如含有或由DNA组成的药剂微粒33。为了避免这种药剂微粒会为动脉中的血流冲出凹腔,此凹腔最初要由挡膜或可回撤套35盖住,如图7所示。
导管的使用与图1至3所示注射器类似。从贮槽10使氦气注入易破碎室12中结果将使薄膜12破碎,使振荡波沿内腔30传播,促使膜盒32突然外翻至图6虚线所示位置,由此使药剂微粒33外推,在套35回撤后或通过挡膜后进入动脉29的壁部。
与图6所示的情形相反,也可根据需要使膜盒32位于导管体部的周边封壳之内,这不仅是为了在其倒转位置时避免插入导管中时受到干扰,还为了在其外翻位置时,避免与动脉壁部碰撞而可能造成损伤。
Claims (13)
1.无针头的注射器,此种注射器包括:带内腔(14、18;30)的体部(13,17,28)此体部内腔的上游端连接或经安排后连接气压源(10),此气压可突然注入上述内腔中;内腔的下游端终止于双稳态的膜盒(21,32)之后,此膜盒可在它于上述体部之外提供一用于盛纳药剂微粒(23,33)的倒转位置和一外翻的外凸位置之间运动;这样的布置形式在使用中能在气体于压力下射到前述内腔中时,使膜盒从其倒转位置迅速地变换到外翻位置而将药剂微粒向外弹出。
2.如权利要求1所述的注射器,特征在于:内腔(14,18;30)的上游端初始时为一可破碎的薄膜(20)所封闭,此薄膜设置成将在充分大的压力的气体作用下破碎,而将气体突然射入所述内腔中。
3.如权利要求1或2所述的注射器,特征在于:内腔(14,18;30)中初始的含有比空气轻的气体。
4.如上述任一项权利要求所述的注射器,特征在于:药剂微粒位于倒转的膜盒的凹腔内。
5.如权利要求4所述的注射器,特征在于:凹腔中的药剂微粒是由可回撤的套(35)盖住。
6.如权利要求4所述的注射器,特征在于:凹腔中的药剂微粒是由在此微粒喷射上时立即穿透的薄护膜(22)所覆盖。
7.如上述任一项权利要求所述的注射器,特征在于:含有内腔的体部是一种管状喷嘴(14,18),膜盒21设在此喷嘴下游端临近并基本上面对喷嘴的轴向。
8.如权利要求7所述的注射器,特征在于:设有一从所述膜盒下游端突伸出的管状隔件(26)。
9.如权利要求1至6中任一项所述的注射器,特征在于:含有内腔的体部是导管(28)。
10.如权利要求9所述的注射器,特征在于:膜盒(32)设于上述导管体部的侧壁中,使得在膜盒外翻时,药剂微粒(33)从此体部沿侧向推进。
11.治疗用的制品,此制品包括依照以前任一项权利要求所述注射器的或用于此注射器的单元件,此单元件包括一拱形的膜盒,在此膜盒的凹侧封入药剂微粒,此膜盒经设置成在有气体式振荡波作用于它的拱形部分上时可突然外翻,由此使药剂微粒从膜盒向外弹出。
12.如权利要求1所述的制品,特征在于:前述药剂微粒是密封在膜盒的凹侧和与此膜盒隔绝的覆盖用挡膜之间。
13.将药剂微粒注入身体组织内进行治疗的方法,此方法包括:在拱形膜盒的凹侧中设置药剂微粒,将气体式振荡波施加到上述拱形膜盒的凸形侧,由此使此拱形膜盒突然外翻并将药剂微粒从膜盒朝外弹出。
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Application Number | Priority Date | Filing Date | Title |
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GB9426379.5 | 1994-12-23 | ||
GBGB9426379.5A GB9426379D0 (en) | 1994-12-23 | 1994-12-23 | Particle delivery |
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CN1171055A true CN1171055A (zh) | 1998-01-21 |
CN1112944C CN1112944C (zh) | 2003-07-02 |
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CN95197014A Expired - Fee Related CN1112944C (zh) | 1994-12-23 | 1995-12-21 | 无针头的注射器 |
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US (3) | US6685669B2 (zh) |
EP (1) | EP0799064B1 (zh) |
JP (1) | JP3114811B2 (zh) |
KR (1) | KR100404247B1 (zh) |
CN (1) | CN1112944C (zh) |
AT (1) | ATE183657T1 (zh) |
AU (1) | AU699463B2 (zh) |
BG (1) | BG63000B1 (zh) |
BR (1) | BR9510464A (zh) |
CA (1) | CA2208590C (zh) |
CZ (1) | CZ290350B6 (zh) |
DE (1) | DE69511723T2 (zh) |
DK (1) | DK0799064T3 (zh) |
ES (1) | ES2138248T3 (zh) |
FI (1) | FI972554A (zh) |
GB (1) | GB9426379D0 (zh) |
GE (1) | GEP19991862B (zh) |
GR (1) | GR3031582T3 (zh) |
HK (1) | HK1000633A1 (zh) |
HU (1) | HU219325B (zh) |
MX (1) | MX9704653A (zh) |
NO (1) | NO313740B1 (zh) |
NZ (1) | NZ297542A (zh) |
OA (1) | OA10494A (zh) |
PL (1) | PL179387B1 (zh) |
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RU (1) | RU2135219C1 (zh) |
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1995
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- 1995-12-21 PL PL95320919A patent/PL179387B1/pl not_active IP Right Cessation
- 1995-12-21 BR BR9510464A patent/BR9510464A/pt not_active IP Right Cessation
- 1995-12-21 AT AT95941237T patent/ATE183657T1/de not_active IP Right Cessation
- 1995-12-21 HU HU9702203A patent/HU219325B/hu not_active IP Right Cessation
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- 1995-12-21 WO PCT/GB1995/003016 patent/WO1996020022A1/en not_active Application Discontinuation
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CN100484582C (zh) * | 2001-10-12 | 2009-05-06 | 费尔顿国际公司 | 带有手持件的射流式注射器 |
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