Sterile aspiration/reinjection systems
First Claim
1. A sterile container assembly for delivering repeated precisely controlled volumes of a liquid therefrom in a sterile condition;
- said sterile container assembly comprising in liquid-tight arrangement;
a liquid-tight housing with an opening of reduced size relative to the housing;
wherein the interior of the housing is maintained in a sterile condition and has a maximum internal volume in the range of about 3 ml to about 70 ml;
a self-sealing puncturable sterile barrier covering the opening for receiving a hollow needle cannula, and a pressure actuator in liquid-tight connection with the interior of the housing, wherein the pressure actuator repeatedly exerts a positive pressure on liquid in the interior of the housing so as to repeatedly expel a precisely controlled volume of the liquid therefrom via the opening without septic contamination of the liquid and without uncontrolled loss of liquid therefrom.
7 Assignments
0 Petitions
Accused Products
Abstract
The invention provides systems containing a sterile container for aspiration, filtering, treating and reinjection into a subject of a bodily fluid in a sterile environment. The systems are particularly designed to facilitate transfection of cells within the sterile container by gene therapy molecules and reinjection of the transfected cells into the donor at controlled depth in precisely controlled volumes such as is useful for revascularization of ischemic cardiac tissue. For injection, a pressure actuator, preferably hand-held, applies force to liquids held within the sterile container in precisely controlled increments, thereby expressing liquids through a hollow needle or injection catheter in precisely controlled microvolumes. The invention systems include a hand-held injection device with audible cues that correspond to an operator-selected injection volume and/or audible cues that correspond to needle penetration depth selected by the operator.
119 Citations
90 Claims
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1. A sterile container assembly for delivering repeated precisely controlled volumes of a liquid therefrom in a sterile condition;
- said sterile container assembly comprising in liquid-tight arrangement;
a liquid-tight housing with an opening of reduced size relative to the housing;
wherein the interior of the housing is maintained in a sterile condition and has a maximum internal volume in the range of about 3 ml to about 70 ml;
a self-sealing puncturable sterile barrier covering the opening for receiving a hollow needle cannula, and a pressure actuator in liquid-tight connection with the interior of the housing, wherein the pressure actuator repeatedly exerts a positive pressure on liquid in the interior of the housing so as to repeatedly expel a precisely controlled volume of the liquid therefrom via the opening without septic contamination of the liquid and without uncontrolled loss of liquid therefrom. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 16)
- said sterile container assembly comprising in liquid-tight arrangement;
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9. A filter assembly for aspiration and filtering of a bodily liquid containing undesired components, said filter assembly comprising in co-axial liquid-tight arrangement:
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one or more filters with pores sized to filter out the undesired components from the liquid and;
a filter receptacle having at least a distal part and a proximal part which parts engage to cooperatively form a liquid-tight enclosure for the one or more filters, wherein the distal part of the filter receptacle attaches to the hub of the aspiration needle;
a hollow needle cannula attached to the exterior of the proximal part of the filter receptacle; and
a liquid-tight liquid connector attached to the exterior of the distal side of the filter receptacle. - View Dependent Claims (10, 11, 12, 13, 14, 15)
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17. A sterile container for treating bodily liquid containing cells, said container comprising in co-axial arrangement:
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a housing having a cylindrical portion and a distal portion of reduced diameter;
a distal opening;
a puncturable, self-sealing sterile barrier covering the distal opening;
one or more piston ring-like stops fixedly mounted circumferentially around an interior wall of the cylindrical portion of the housing;
a piston-like plunger having a domed head portion shaped to conform to the interior of the distal end of the housing;
wherein the plunger is liquid-tightly and moveably mounted within the cylindrical portion of the housing so that the stroke of the plunger is defined by abutment of the head portion against the distal opening and against a stop; and
a proximally extending plunger handle for moving the plunger within the cylindrical portion of the housing;
wherein the sterile barrier, the cylindrical portion of the housing, and the exterior of the domed head portion of the plunger form an expandable and compressible sterile chamber. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A sterile system for injection of one or more precisely controlled volumes of a liquid, said system comprising:
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a) a sterile container, said container comprising in co-axial arrangement;
a housing having a cylindrical portion and a distal portion of reduced diameter;
a distal opening;
a puncturable, self-sealing sterile barrier covering the distal opening;
one or more piston ring-like stops fixedly mounted circumferentially around an interior wall of the cylindrical portion of the housing;
a piston-like plunger having a domed head portion shaped to conform to the interior of the distal end of the housing;
wherein the plunger is liquid-tightly and moveably mounted within the cylindrical portion of the housing so that the stroke of the plunger is defined by abutment of the head portion against the distal opening and against a stop; and
a plunger handle for moving the plunger within the cylindrical portion of the housing;
wherein the sterile barrier, the cylindrical portion of the housing, and the exterior of the domed head portion of the plunger form an expandable and compressible sterile chamber;
b) a hollow needle in fluid communication with the sterile chamber via the sterile barrier of the sterile container; and
(c) a pressure actuator operationally coupled to the plunger handle of the sterile container wherein the pressure actuator exerts a positive pressure on liquid in the sterile chamber so as to expel liquids therefrom in a controlled volume by distal movement of the container plunger one or more precisely controlled longitudinal distances. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A hand-operated injection system for injection of a precisely controlled volume of a therapeutic fluid in a sterile condition, said system comprising in sterile, fluid-tight communication:
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a) a sterile container, said sterile container comprising;
an elongated liquid-tight housing with an opening of reduced size relative to the housing;
wherein the interior surface the housing defines a sterile fluid chambera self-sealing puncturable sterile barrier covering the opening for receiving a hollow needle cannula, and a hand-operated plunger constructed and arranged within said chamber for reciprocal motion within the chamber;
b) an injection syringe, said injection syringe comprising;
an elongated barrel having an inner surface defining a fluid chamber and a distal fluid port, a plunger constructed and arranged within said fluid chamber for reciprocal motion within the fluid chamber;
c) an adjustable plunger arrester positioned with respect to the syringe plunger so as to precisely and adjustably control proximal travel of the plunger;
d) a needle connector comprising a hollow needle cannula and connector for attachment of a hollow injection needle; and
e) one way liquid flow valves for directing discrete liquid flow from the opening of the sterile container via the puncturable, sterile barrier into the distal fluid port of the syringe and from the fluid port of the syringe into the needle connector;
wherein the controlled distance of proximal travel of the plunger allowed by the plunger arrester precisely controls the volume of the sterile fluid expelled from the system upon depression of the syringe plunger. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62)
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63. A hand-operated injection system for injection of a precisely controlled volume of a therapeutic fluid in a sterile condition, said system comprising in sterile, fluid-tight communication:
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a) a fluid-tight sterile container, said sterile container comprising;
an elongated liquid-tight housing with a distal opening of reduced size relative to the housing;
wherein the interior surface the housing defines a sterile fluid chamber having a maximum internal volume in the range from about 10 ml to about 30 ml;
a self-sealing puncturable sterile barrier covering the opening for receiving a hollow needle cannula, a plunger constructed and arranged within said chamber for reciprocal motion within the chamber, said plunger comprising a distal head and proximal plunger handle extending from the proximal end of the housing;
a fluid-tight seal moveably mounted on the extending portion of the plunger handle so as to maintain a seal of the fluid chamber upon reciprocal motion of the plunger, and b) an elongated holder for grasping by the operator, said holder comprising an elongated side portion, an opening at the distal end, and an end piece closing the proximal end wherein the holder is shaped for rotatable plunger-first reception of the sterile container and wherein each rotation or partial rotation of the holder about the sterile container causes the plunger to expel a precisely controlled volume of a fluid contained in the sterile chamber, and c) a signaling mechanism formed by cooperative interaction of the holder and the plunger handle during the rotation generates a sensible signal;
wherein the signal advises the operator how many of the precisely controlled volumes of the fluid have been expelled as a result of the operator causing the rotation of the holder about the sterile container. - View Dependent Claims (64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90)
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Specification