Patent Grant
10933190
The present disclosure is related to syringes for use in the medical field and, more particularly, to syringes having a flexible sidewall that rolls upon itself when acted upon by a plunger for selectively filling the syringe with a fluid and discharging the fluid from the syringe.
In many medical diagnostic and therapeutic procedures, a medical practitioner, such as a physician, injects a patient with one or more medical fluids. In recent years, a number of injector-actuated syringes and powered fluid injectors for pressurized injection of medical fluids, such as a contrast solution (often referred to simply as “contrast”), a flushing agent, such as saline, and other medical fluids, have been developed for use in procedures such as angiography, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET), and other imaging procedures. In general, these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure and/or flow rate.
Typically, powered injectors have drive members, such as pistons, that connect to a syringe plunger within the syringe. The syringe generally includes a rigid barrel with the syringe plunger being slidably disposed within the barrel. The drive members drive the plungers in a proximal and/or distal direction relative to a longitudinal axis of the barrel to draw fluid into the syringe barrel or deliver the fluid from the syringe barrel.
It is well known that syringes used in the medical field are typically disposable and are discarded after one use. Although disposable syringes are typically made by mass production methods such as injection molding, such disposable syringes are relatively expensive due to the materials and precision involved in their manufacture and economic costs associated with packaging and shipping. Accordingly, it remains desirable to develop improved designs of syringes to facilitate injection procedures.
The present disclosure generally relates to syringe assemblies and to methods of forming syringe assemblies. The syringe assemblies may be useful in fluid delivery applications.
In some aspects, a rolling diaphragm syringe may include a proximal end having an end wall for engagement with a piston, a distal end having an open-ended discharge neck, a sidewall extending between the proximal end and the distal end along a longitudinal axis, and a piston engagement portion protruding proximally from a central portion of the outer surface of the end wall and configured for reversible engagement with a piston of a fluid injector. The piston engagement portion may have a stem with a first end attached to the end wall, a second end extending proximally from the first end, and at least one engagement member at or near the second end that protrudes radially outward or radially inward relative to an outer surface of the stem. The sidewall may be flexible and roll upon itself when acted upon by the piston such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the piston is advanced from the proximal end to the distal end. The outer surface of the sidewall may unroll as the folding region is unfolded in a radially outward direction as the piston is retracted from the distal end to the proximal end.
In other aspects, at least a portion of the end wall may have non-uniform thickness. The thickness of the end wall may continuously increase in thickness in a radially inward direction. The end wall may have a radiused folding edge such that at least a portion of the end wall continuously increases in thickness in a radially inward direction from the radiused folding edge. The discharge neck may have a connection member for connecting to a cap. The at least one engagement member may have a distal surface configured for engaging one or more engagement pins or surfaces of the piston during movement of the piston in the proximal direction. The at least one engagement member may be monolithically formed with the second end of the stem. Alternatively, the at least one engagement member may be attached to the second end of the stem, for example by adhesive, laser welding, or a mechanical or screw type mechanism. Alternatively, the rolling diaphragm syringe may be initially in a compressed, rolled state which is unrolled during a filling process by engaging the rolling diaphragm syringe with a piston and drawing the end wall in a proximal direction.
In other aspects, a syringe for a fluid delivery system may include a pressure jacket having an open distal end, an open proximal end, and a sidewall with a throughbore extending between the distal end and the proximal end. The syringe may further include a rolling diaphragm configured to be received within the throughbore of the pressure jacket. The rolling diaphragm may have a proximal end having an end wall for engagement with a piston, a distal end having an open-ended discharge neck, and a sidewall extending between the proximal end and the distal end along a longitudinal axis. The sidewall of the rolling diaphragm may define an interior volume for receiving a medical fluid therein. The rolling diaphragm further may have a piston engagement portion protruding proximally from a central portion of the end wall and configured for engagement with a piston of a fluid injector. The piston engagement portion may have a stem with a first end attached to the end wall, a second end extending proximally from the first end, and at least one engagement member at or near the second end that protrudes radially outward or radially inward relative to an outer surface of the stem. The syringe may also have a cap configured for engaging at least one of the distal end of the pressure jacket and the distal end of the rolling diaphragm to connect to the open-ended discharge neck of the rolling diaphragm. The sidewall of the rolling diaphragm may be flexible and roll upon itself when acted upon by the piston such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the piston is advanced from the proximal end to the distal end. The outer surface of the sidewall may unroll as the folding region is unfolded in a radially outward direction as the piston is retracted from the distal end to the proximal end. The at least one engagement member may have a distal surface configured for engaging one or more engagement pins or surfaces of the piston during movement of the piston in the proximal direction. The at least one engagement member may be monolithically formed with the second end of the stem. Alternatively, the at least one engagement member may be attached to the second end of the stem, for example by adhesive, laser welding, or a mechanical or screw type mechanism. An interior of the rolling diaphragm syringe may be pre-filled with the medical fluid. Alternatively, the rolling diaphragm syringe may be initially in a compressed, rolled state which is unrolled during a filling process by engaging the rolling diaphragm syringe with a piston and drawing the end wall in a proximal direction.
In other aspects, the proximal end of the pressure jacket may have at least one locking lip or lug protruding radially outward from an outer surface of the sidewall of the pressure jacket for releasably locking the pressure jacket with a fluid injector. The cap may have at least one projection or groove that interacts with a corresponding groove or projection on the distal end of the pressure jacket for releasably securing the cap to the pressure jacket when the rolling diaphragm syringe is inserted into the distal end of the pressure jacket. The cap may have a nozzle or other fluid discharge port and an annular sidewall surrounding the nozzle or fluid discharge port configured for releasable attachment to a tube set, for example by a luer fit, for delivering the fluid to the interior of the rolling diaphragm syringe during a filling operation and delivering the fluid from the rolling diaphragm syringe to a patient during an injection procedure. The annular sidewall may have one or more gripping elements protruding radially outward from the outer surface of the annular sidewall for gripping an inner surface of the pressure jacket to secure the cap to the pressure jacket. The cap may be non-removably secured to the discharge neck of the rolling diaphragm syringe. The cap may have at least one engagement element for removably connecting the cap with the distal end of the pressure jacket. The cap may be welded to the discharge neck such that the cap is monolithically formed with the discharge neck. Alternatively, the cap may be adhesively bonded to the discharge neck. The protrusion of the piston engagement portion may have a distal surface configured for engaging one or more engagement pins or surfaces of the piston during movement of the piston in the proximal direction. At least a portion of the end wall may have non-uniform thickness. The thickness of the end wall may continuously increase in a radially inward direction. The cap may have a nozzle in fluid communication with the interior volume of the rolling diaphragm syringe, for example through the discharge neck. The nozzle may have a connector for connecting to a fluid path set. The connector may be a luer connector.
In other aspects, a rolling diaphragm syringe for receiving a medical fluid therein may have a proximal end having an end wall for engagement with a piston, a distal end having an open-ended discharge neck, and a sidewall extending between the proximal end and the distal end along a longitudinal axis. The sidewall of the rolling diaphragm syringe may define an interior volume for receiving the medical fluid therein. The rolling diaphragm syringe further may have a piston engagement portion protruding proximally from a central portion of the end wall and configured for engagement with a piston of a fluid injector. The piston engagement portion may have a stem with a first end attached to the end wall, a second end extending proximally from the first end, and at least one engagement member at the second end that protrudes radially outward or radially inward relative to an outer surface of the stem. The rolling diaphragm syringe further may have a cap secured to the discharge neck of the rolling diaphragm syringe. The cap may have a nozzle in fluid communication with the interior volume of the rolling diaphragm syringe. The sidewall of the rolling diaphragm syringe may be flexible and roll upon itself when acted upon by the piston such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the piston is advanced from the proximal end to the distal end. The outer surface of the sidewall may unroll as the folding region is unfolded in a radially outward direction as the piston is retracted from the proximal end to the distal end.
Various other aspects of the present invention are recited in one or more of the following clauses:
Clause 1: A rolling diaphragm syringe for receiving a medical fluid therein, the rolling diaphragm syringe comprising:
Clause 2: The rolling diaphragm syringe of clause 1, wherein at least a portion of the end wall has non-uniform thickness.
Clause 3: The rolling diaphragm syringe of clause 1 or clause 2, wherein the outer surface of the sidewall is unfolded in a radially outward direction as the piston is retracted from the distal end to the proximal end.
Clause 4: The rolling diaphragm syringe of any of clauses 1-3, wherein the end wall has a radiused folding edge and wherein at least a portion of the end wall continuously increases in thickness in a radially inward direction from the radiused folding edge.
Clause 5: The rolling diaphragm syringe of any of clauses 1-4, wherein the discharge neck has a connection member for connecting to a cap.
Clause 6: The rolling diaphragm syringe of any of clauses 1-5, wherein the protrusion has a distal surface configured for engaging one or more engagement pins of the piston during movement of the piston in the proximal direction.
Clause 7: The rolling diaphragm syringe of any of clauses 1-6, wherein the protrusion is monolithically formed with the second end of the stem.
Clause 8: The rolling diaphragm syringe of any of clauses 1-7, wherein the rolling diaphragm is initially in a compressed, rolled state and is configured to be unrolled during a filling process as the piston retracts the end wall in a proximal direction.
Clause 9: A syringe assembly for a fluid delivery system, the syringe assembly comprising:
Clause 10: The syringe assembly of clause 9, wherein the proximal end of the pressure jacket has at least one locking lip or lug protruding radially outward from an outer surface of the sidewall of the pressure jacket for releasably locking the pressure jacket with a fluid injector.
Clause 11: The syringe assembly of clause 9 or clause 10, wherein the cap has at least one projection or groove that interacts with a corresponding groove or projection on the distal end of the pressure jacket for releasably securing the cap to the pressure jacket.
Clause 12: The syringe assembly of any of clauses 9-11, wherein the cap has a nozzle and an annular sidewall surrounding the nozzle, the sidewall having one or more gripping elements protruding radially outward from the outer surface of the annular sidewall.
Clause 13: The syringe assembly of any of clauses 9-12, wherein the cap is non-removably secured to the discharge neck of the rolling diaphragm syringe and wherein the cap has an engagement element for removably connecting the cap with the distal end of the pressure jacket.
Clause 14: The syringe assembly of any of clauses 9-13, wherein the outer surface of the sidewall is unfolded in a radially outward direction as the piston is retracted from the distal end to the proximal end.
Clause 15: The syringe assembly of any of clauses 9-14, wherein the protrusion of the piston engagement portion has a distal surface configured for engaging one or more engagement pins of the piston during movement of the piston in the proximal direction.
Clause 16: The syringe assembly of any of clauses 9-15, wherein at least a portion of the end wall has non-uniform thickness.
Clause 17: The syringe assembly of clause 16, wherein the thickness of the end wall continuously increases in a radially inward direction.
Clause 18: The syringe assembly of any of clauses 9-17, wherein the cap has a nozzle in fluid communication with the interior volume of the rolling diaphragm syringe, the nozzle having a connector for connecting to a fluid path set.
Clause 19: The syringe assembly of clause 18, wherein the connector is a luer connector.
Clause 20: A rolling diaphragm syringe for receiving a medical fluid therein, the rolling diaphragm syringe comprising:
Further details and advantages of the various aspects described in detail herein will become clear upon reviewing the following detailed description of the various aspects in conjunction with the accompanying drawing figures.
The illustrations generally show preferred and non-limiting aspects of the systems and methods of the present disclosure. While the description presents various aspects of the devices, it should not be interpreted in any way as limiting the disclosure. Furthermore, modifications, concepts, and applications of the disclosure's aspects are to be interpreted by those skilled in the art as being encompassed, but not limited to, the illustrations and descriptions herein.
The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the disclosure. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present disclosure.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. When used in relation to a syringe, a pressure jacket, and/or a rolling diaphragm syringe, the term “proximal” refers to a portion of a syringe, a pressure jacket, and/or a rolling diaphragm syringe nearest to an injector when a syringe, a pressure jacket, and/or a rolling diaphragm syringe is oriented for connecting to an injector. The term “distal” refers to a portion of a syringe, a pressure jacket, and/or a rolling diaphragm syringe farthest away from an injector when a syringe, a pressure jacket, and/or a rolling diaphragm syringe is oriented for connecting to an injector. The term “radial” refers to a direction in a cross-sectional plane normal to a longitudinal axis of a syringe, a pressure jacket, and/or a rolling diaphragm syringe extending between proximal and distal ends. The term “circumferential” refers to a direction around an inner or outer surface of a sidewall of a syringe, a pressure jacket, and/or a rolling diaphragm syringe. The term “axial” refers to a direction along a longitudinal axis of a syringe, a pressure jacket, and/or a rolling diaphragm syringe extending between the proximal and distal ends. The term “flexible”, when used in connection with a rolling diaphragm syringe, means that at least a portion of a rolling diaphragm syringe, such as a sidewall of a rolling diaphragm syringe, is capable of bending or being bent to change a direction in which it extends. The terms “roll over”, “rolling over”, and “rolls upon itself” refer to an ability of a first portion of a rolling diaphragm syringe, such as a proximal portion of a sidewall of a rolling diaphragm syringe, to bend approximately 180 relative to a second portion of a rolling diaphragm syringe, such as a distal portion of a sidewall of a rolling diaphragm syringe, when urged by a piston of a fluid injector. It is to be understood, however, that the disclosure may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the aspects (i.e., aspects, variants, variations) disclosed herein are not to be considered as limiting.
Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, the present disclosure is generally directed to syringe configured as a rolling diaphragm syringe.
With reference to
The injector 102 may be enclosed within a housing 126 formed from a suitable structural material, such as plastic or metal. The housing 126 may be of various shapes and sizes depending on the desired application. For example, the injector 102 may be a free-standing structure configured to be placed on the floor or may be a smaller design for placement on a suitable table or support frame. The injector 102 includes at least one port for interfacing the at least one rolling diaphragm syringe 112 and pressure jacket 110 to respective pistons.
At least one fluid path set 108 may be fluidly connected with a nozzle 130 of the at least one syringe assembly 104 comprising a rolling diaphragm syringe 112 and pressure jacket 110 for delivering medical fluid from the at least one rolling diaphragm syringe 112 through tubing connected to a catheter, needle, or other fluid delivery connection (not shown) inserted into a patient at a vascular access site. Fluid flow into and from the at least one syringe assembly 104 may be regulated by a fluid control module (not shown). The fluid control module may operate various pistons, valves, and/or flow regulating structures to regulate the delivery of the medical fluid, such as saline solution and contrast, to the patient based on user selected injection parameters, such as injection flow rate, duration, total injection volume, and/or ratio of contrast media and saline. One example of a suitable front-loading fluid injector that may be used or modified for use with the herein-described system including at least one rolling diaphragm syringe 112 and at least one interface for loading and releasable retaining of the at least one rolling diaphragm syringe 112 and the pressure jacket 110 with the fluid injector 102 described herein with reference to
The cylindrical body of pressure jacket 110 may be a unitary, typically cylindrical body having a distal end 116 and a proximal end 118 with a throughbore T extending between the distal end 116 and the proximal end 118. The pressure jacket 110 is typically a reusable component, while the rolling diaphragm syringe 112 is typically a single-use component. In another aspect, the rolling diaphragm syringe 112 may be reusable such that the rolling diaphragm syringe 112 is refillable with fluid. For example, the rolling diaphragm syringe 112 can be pre-filled with fluid, or can be initially empty, and can be filled and/or refilled one or more times. When the rolling diaphragm syringe 112 is initially empty, it may be initially in the compressed state where it may be filled with the fluid by proximal retraction of the proximal end wall; or alternatively, the rolling diaphragm syringe 112 may be in the uncompressed state and may be filled with the fluid, for example through a discharge neck 140 or through a nozzle or outlet port in a distal end cap. In another aspect, both the pressure jacket 110 and the rolling diaphragm syringe 112 may be single-use components that are disposed of after each patient use. In this aspect, both the pressure jacket 110 and the rolling diaphragm syringe 112 are disposed of after use and a new pressure jacket 110 and rolling diaphragm syringe 112 are loaded into the fluid injector 102 for subsequent use. The pressure jacket 110 has a sidewall 120 that defines a throughbore T between the distal and proximal ends 116, 118. An inner surface of the throughbore T may be smooth, textured, or a combination thereof. The proximal end 118 is adapted to interface with the fluid injector 102 and includes one or more mounting structures 122 positioned to engage a locking mechanism at the front end or face plate 124 of the housing 126 of the fluid injector 102 to properly seat the pressure jacket 110 relative to the fluid injector 102. As an example, two opposed bayonet attachment flanges may be provided on the proximal end 118 for interfacing with the fluid injector face plate 124 to secure the pressure jacket 110 to the fluid injector 102. In some aspects, the pressure jacket 110 may have a connection member to releasably secure the pressure jacket to the fluid injector 102 in the form of a connection member described in U.S. Pat. No. 9,173,995, entitled “Self-Orienting Syringe and Syringe Interface”, in U.S. Pat. No. 9,199,033, entitled “Self-Orienting Syringe and Syringe Interface”, International Application No. PCT/US2015/057751, filed Oct. 28, 2015, or International Application No. PCT/US2015/057747, filed Oct. 28, 2015, the disclosures of which are incorporated herein by reference in their entirety. In another aspect, an adapter may be provided for connecting the pressure jacket 110 and rolling diaphragm syringe 112 to the fluid injector 102.
The distal end 116 of the pressure jacket 110 may include a substantially frusto-conical portion or be configured to connect with a substantially frusto-conical cap portion, each of which may terminate in an outlet port 128. The pressure jacket 110 may be made of any suitable medical grade material, such as but not limited to a medical grade metal, medical grade composite material, or medical grade plastic material, desirably a clear plastic material, such as, but not limited to, polycarbonate, acrylic, or polyester. In some aspects, the pressure jacket 110 may be releasably secured to the fluid injector 102, for example but not limited to, by a retractable pin that extends through an opening of the pressure jacket 110 to prevent rotation of the pressure jacket 110 when it has been loaded onto the fluid injector 102, for example when attaching or detaching a cap portion to the distal end of the pressure jacket. In other aspects, the pressure jacket 110 may have one or more legs that engage the housing of the fluid injector 102 to prevent rotation of the pressure jacket 110 when it had been loaded onto the fluid injector 102. In further aspects, a sliding collar may be provided around an outer circumference of the pressure jacket 110. The sliding collar desirably engages an expandable ring to expand the ring against a corresponding locking feature of the fluid injector 102 to lock the pressure jacket 110 with the fluid injector 102.
With reference to
The rearward or proximal portion of the sidewall 134 connects to the closed end wall 136, and a forward or distal portion of the sidewall 134 defines a discharge neck 140 opposite the closed end wall 136. The closed end wall 136 may have a non-uniform thickness, for example in a radial direction extending from a central longitudinal axis of the rolling diaphragm syringe 112. In certain aspects, at least a portion of the end wall 136 may be thicker near the center and thinner near the connection with the sidewall 134. In other aspects, the discharge neck 140 is adapted to be received in the interior portion of the distal end 116 of the pressure jacket 110 such that the discharge neck 140 is aligned with the outlet port 128 of the pressure jacket 110 or cap 390. The distal end 130 of the rolling diaphragm syringe 112 may be secured permanently within the interior of the pressure jacket 110, adhesively secured therein, or be removably secured therein such as by a friction fit connection or other suitable mechanical connection, such as by securing at the distal end of the pressure jacket 110. The distal end 130 may have a frusto-conical shape that gradually narrows from the sidewall 134 to the discharge neck 140. In certain aspects, the discharge neck 140 may terminate in a discharge port 142 that may have, according to one non-limiting aspect, a fracturable seal (discussed herein) for sterility purposes, such as piercable foil or an elastomeric seal.
The sidewall 134 of the rolling diaphragm syringe 112 defines a soft, pliable or flexible, yet self-supporting body that is configured to roll upon itself, as a “rolling diaphragm”, under the action of the piston 138 and/or plunger 144. In particular, as shown in
The rolling diaphragm syringe 112 may be made of any suitable medical-grade plastic or polymeric material, desirably a clear or substantially translucent plastic material, such as, but not limited to, polyproplylene random copolymer, polyproplylene impact copolymer, polyproplylene homopolymer, polypropylene, polyethylene terephthalate, POM, ABS, HPDE, nylon, cyclic olefin copolymer, multilayer polypropylene, polycarbonate, ethylene vinyl acetate, polyethylene, and the like. The material of the rolling diaphragm syringe 112 is desirably selected to meet the required tensile and planar stress requirements, water vapor transmission, and chemical/biological compatibility. In some aspects, the rolling diaphragm syringe 112 may have at least one electro-active polymer layer that expands or contracts in response to an application of an electrical voltage. The electro-active polymer layer may be activated to expand or contract the sidewall 134 of the rolling diaphragm syringe 112 to disengage or engage the piston 138. In some aspects, the electro-active polymer layer may be made from a NAFION™ or FLEMION™ materials. In various aspects, the clear plastic material may withstand sterilization procedures, such as exposure to ethylene oxide or electromagnetic radiation sterilization procedures.
The rolling diaphragm syringe 112 according to various aspects herein may be made by a blow-fill-cap (BFC) technique, also referred to in the relevant field of endeavor as a blow-mold-seal (BFS) technique, wherein the rolling diaphragm syringe 112 is blow-molded, optionally filled with the desired medical fluid, such as saline or contrast media, and aseptically sealed by sealing the discharge port 142 with an integrally formed/molded rupture-ready seal, as will be described hereinafter. Alternatively, the rolling diaphragm syringe 112 may be compressed into a compressed state and packaged in a sterilizable packing material for shipping, with optional sealing of the syringe to prevent contamination. The BFC/BFS techniques permit the rolling diaphragm syringe 112 to be formed and optionally filled, and sealed typically in one machine or apparatus. These steps may be accomplished under sterility maintained conditions, limiting the possibility of introducing contaminates in the formed, filled, and sealed rolling diaphragm syringe 112. The entire assembly may be autoclaved or otherwise treated for sterilization, such as by irradiation. The rupture-ready seal is formed as part of the molding process at the conclusion of the filling of the rolling diaphragm syringe 112. A sterility-enhanced preformed and prefilled rolling diaphragm syringe 112 results from the BFC/BFS process. The rupture-ready seal may be designed for external removal or puncture by a user, or may be designed to reliably burst when a preset internal pressure is reached in the rolling diaphragm syringe 112 as the piston 138 moves distally or forward in the rolling diaphragm syringe 112. In another aspect, the rolling diaphragm syringe 112 may be ruptured by a piercing element provided on the pressure jacket 110. In another aspect, the rolling diaphragm syringe 112 may be encased in a protective cover (not shown) to increase its rigidity and prevent contamination. The protective cover may or may not be removed from the rolling diaphragm syringe 112 prior to installation on the injector 102. The rolling diaphragm syringe 112 may be formed to have a variety of shapes. For example, the rolling diaphragm syringe 112 may be cylindrical, conical, spherical, ellipsoidal, egg-shaped, etc. Furthermore, the rolling diaphragm syringe 112 may have different width to length ratios. For example, the rolling diaphragm syringe 112 may be formed to have a diameter that is substantially smaller or larger compared to its longitudinal length. One of ordinary skill in the art will understand that the injector 102 may be desirably programmed to control the movement of the piston 138 in order to deliver a substantially constant and predictable flow rate of fluid from the rolling diaphragm syringe 112. In other aspects, the rolling diaphragm syringe 112 may be formed by a blow-stretch molding process from a preform, such as a process described in International patent application No. PCT/US2014/063477, filed Oct. 31, 2014, the disclosure of which is incorporated herein by this reference.
The outer diameter of the rolling diaphragm syringe 112 may be dimensioned such that the rolling diaphragm syringe 112 fits within the interior space defined by the throughbore and inner surface of the pressure jacket 110. In one aspect, the rolling diaphragm syringe 112 fits snuggly within the pressure jacket 110 such that the outer surface of the rolling diaphragm syringe 112 abuts the inner surface of the walls of the pressure jacket 110. In another aspect, the rolling diaphragm syringe 112 fits loosely within the pressure jacket 110 such that there is a gap between at least a portion of the outer surface of the rolling diaphragm syringe 112 and the inner surface of the pressure jacket 110. The rolling diaphragm syringe 112 may be expanded under pressure during an injection procedure such that the outer surface of the rolling diaphragm syringe 112 abuts the inner surface of the pressure jacket 110.
Referring initially to
With reference to
The end wall 134 may have a central portion 276 having a substantially dome-shaped structure and a piston engagement portion 244 extending proximally from the central portion 276, such as an approximate midpoint of the central portion 276. In some aspects, a distal most end of the central portion 276 may be substantially flat. The piston engagement portion 244 is configured for engagement with the engagement mechanism on the piston of the fluid injector 102, as described herein. The proximal end 132 of the rolling diaphragm syringe 112 may have one or more ribs 278 protruding radially outward from the piston engagement portion 244 along a proximal surface of the ramp 272.
In some aspects, the second proximal portion 360b has a flange 380 protruding radially outward from an outer surface of the second proximal portion 360b. The flange 380 may extend continuously or discontinuously around an outer circumference of the second proximal portion 360b. Desirably, the flange 380 extends continuously around the entire outer circumference of the second proximal portion 360b. The flange 380 is configured for collecting any fluid that may drip from the nozzle 410 of the rolling diaphragm syringe 112 into the connection port of the fluid injector 102.
In some aspects, the second proximal portion 360b has a locking lug or lip 370 protruding radially outward from an outer surface of the second proximal portion 360b. The locking lug or lip 370 may extend continuously or discontinuously around an outer circumference of the second proximal portion 360b. The locking lug or lip 370 is configured for interacting with corresponding features on the fluid injector 102 to releasably lock the pressure jacket 110 with the fluid injector 102. In some aspects, the locking lug or lip 370 may have a connection member to releasably secure the pressure jacket 110 to a corresponding locking mechanism of the fluid injector 102 described in U.S. Pat. Nos. 5,383,858; 5,873,861; 6,652,489, 9,173,995; and 9,199,033. Other connection members between the pressure jacket 110 and the fluid injector 102 are described in International Application No. PCT/US2015/057751, filed Oct. 28, 2015, or International Application No. PCT/US2015/057747, filed Oct. 28, 2015.
With reference to
The cap 390 may have a pocket 450 for collecting any fluid that may drip from the nozzle 410 and/or the connector 420. The pocket 450 is defined by an annular sidewall 460 that extends around the nozzle 410 and the connector 420. The annular sidewall 460 may have one or more gripping elements 470 to facilitate gripping of the cap 390 when the cap 390 is connected to and/or disconnected from the pressure jacket 110. In some aspects, the gripping elements 470 may protrude radially outward from at least a portion of the outer surface of the annular sidewall 460. The cap 390 may have a radial flange 480 that extends radially outward from a proximal portion of the annular sidewall 460. The radial flange 480 may extend continuously or discontinuously around an outer circumference of the cap 390. Desirably, the radial flange 480 extends continuously around the entire outer circumference of the cap 390. The radial flange 480 may have the same outer diameter as the pressure jacket 110 such that an outer radial surface of the radial flange 480 is flush with the diameter of the outer sidewall 119 of the pressure jacket 110.
With reference to
As further shown in
With reference to
The second end 244c has an engagement member, such as at least one flange or protrusion 244d, that protrudes radially outward relative to the diameter of the stem 244a. In some aspects, the engagement member may be configured as a lip (not shown) that is recessed radially inward into the stem 244a. The at least one protrusion 244d may extend circumferentially around at least a portion of the stem 244a in a continuous or discontinuous manner. In some aspects, the protrusion 244d may be monolithically formed with the stem 244a. In other aspects, the protrusion 244d may be formed separately from the stem 244a and removably or non-removably attached to the stem 244a. In one aspect, the engagement member protrusion 244d may be attached to the proximal end of stem 244a, for example by an adhesive or by a mechanical mechanism. For example, in one aspect the engagement member may be screwed into the proximal end of stem 244a wherein the screw head may form protrusion 244d. In other aspects, the protrusion 244d may be integrally formed with the stem 244a in one or multiple manufacturing steps, such as by molding the protrusion 244d together with the stem 244a, or molding the stem 244a first followed by a separate manufacturing process to form the protrusion 244d. In one aspect, the protrusion 244d may be formed by heating and rolling or compressing the second end 244c of the stem 244a after the stem 244a is molded. The protrusion 244d is configured for interacting with one or more engagement pins or surfaces of the engagement mechanism 500 that move radially inward and outward to engage and disengage, respectively, the stem 244 of the rolling diaphragm syringe 112 with the engagement mechanism 500 of the fluid injector 102. In some aspects, the protrusion 244d has a distally facing surface 244e configured to engage a proximal surface of the one or more engagement pins/surfaces 520, as described herein.
With continued reference to
The abutment section 514 is axially movable relative to the outer piston section 510. Abutment of a distally facing flange or ledge 516 of the abutment section 514 with a proximal surface of the outer piston sleeve 512 causes the piston 138 to move distally relative to the rolling diaphragm syringe 112 to expel fluid from the interior volume of the rolling diaphragm syringe 112. The abutment section 514 is movable or slidable in an axial direction relative to the outer piston section 510 to control the state or position of one or more engagement pins or surfaces 520. The motion of the abutment section 514 relative to the outer piston section 510 is limited to allow engagement or disengagement of the pins/surfaces 520 with engagement member protrusion 244d. For example, such relative motion can be limited using a pin 522 fixed to abutment section 514. The pin 522 passes through and seats within a slot formed in the outer piston sleeve 510. In some aspects, the abutment section 514 may be movable by about 0.100 to 0.150 inches, for example 0.125 inches, before the outer piston section 510 is moved together with the abutment section 514.
The piston 138 also has an inner piston section 518 having a central opening 524. The central opening 524 of the inner piston section 518 is concentric with an opening 504 that extends through a central portion of the outer piston section 510 along a longitudinal axis 506 of the piston 138. The central opening 524 of the inner piston section 518 and the opening 504 of the outer piston section 510 are shaped to receive the piston engagement portion 244 of the rolling diaphragm syringe 112. Desirably, an inner diameter of the openings 504, 524 is slightly larger than an outer diameter of the widest portion of the piston engagement portion 244 to allow free insertion of the piston engagement portion 244 into the openings 504, 524. In certain aspects, diameter of the opening 504 is conical to guide engagement portion 244 into the correct position for engagement or disengagement of the pins/surfaces 520 with engagement member protrusion 244d.
With continued reference to
The radial extension and retraction of the one or more engagement pins/surfaces 520 is controlled by engagement with at least a portion of the clamping ring 528 during proximal movement of the piston 138 and at least a portion of the abutment section 514 during distal movement of the piston 138, respectively. The abutment section 514 has an opening ramp 532 while the clamping ring 528 has a closing ramp 534. The opening and closing ramps 532, 534 are surfaces that are angled relative to the longitudinal axis 506 such that movement of the abutment section 514 relative to the inner piston section 518 urges the one or more pins/surfaces 520 to contact one of the ramps 532, 534 and effect radially inward or outward movement of the one or more pins/surfaces 520. During movement of the piston 138 in the proximal direction, such as shown by arrow A in
Fluid can be delivered from the interior volume 114 of the rolling diaphragm syringe 112 by driving the piston 138 in the distal direction. During movement of the piston 138 in the proximal direction, such as shown by arrow B in
A force that the plunger 144 needs to exert on the proximal end wall 132 of the rolling diaphragm syringe 112 to withdraw the end wall 132 in a controlled manner without longitudinal bending or pleating of the sidewall 134 of the rolling diaphragm syringe 112 is a function of one or more material properties of the rolling diaphragm syringe 112, such as Young's modulus of elasticity, thickness of the sidewall 134 at a folding region, frictional force between the plunger 144 and the inwardly facing outer sidewall of the rolling diaphragm syringe 112, and a diameter of the plunger 144 relative to a diameter of the rolling diaphragm syringe 112. In certain cases, during the rolling or unrolling of the sidewall 134, such as during a fluid filling or delivery procedure, one or more folds 500 may be developed at or near the rolled portion of the sidewall 134, which may result in error or inaccuracy in the volume of fluid drawing into or delivered from the rolling diaphragm syringe 112. With reference to
In some aspects, pleating can be reduced or eliminated by controlling the plunger outer diameter relative to the outer diameter of the rolling diaphragm syringe 112 for a rolling diaphragm syringe 112 of a given material and sidewall thickness. In one test analysis, a first rolling diaphragm syringe 112 made from a PET material and having a sidewall thickness of 0.006″ with a 1.805″ outer diameter was rolled using a plunger 144 having an outer diameter of 1.609″ (
While aspects of a fluid delivery system and a syringe for use therefor were provided in the foregoing description, those skilled in the art may make modifications and alterations to these aspects without departing from the scope and spirit of the disclosure. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The disclosure described hereinabove is defined by the appended claims and all changes to the disclosure that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.
This application is a 371 national phase application of PCT International Application No. PCT/US2016/028824, filed Apr. 22, 2016, and claims priority to U.S. Provisional Patent Application No. 62/152,511, entitled “Syringe With Rolling Diaphragm” and filed on Apr. 24, 2015, and U.S. Provisional Patent Application No. 62/257,053, entitled “Syringe With Rolling Diaphragm” and filed on Nov. 18, 2015, the disclosures of which are incorporated by reference herein in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2016/028824 | 4/22/2016 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2016/172467 | 10/27/2016 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 352715 | Sandmark | Nov 1886 | A |
| 798093 | Edward | Aug 1905 | A |
| 937029 | Blessing et al. | Oct 1909 | A |
| 2514575 | Hein et al. | Jul 1950 | A |
| 2667163 | Smith | Jan 1954 | A |
| 2667164 | Smith | Jan 1954 | A |
| 2667165 | Smith | Jan 1954 | A |
| 2667872 | Smith | Feb 1954 | A |
| 2672866 | Kater | Mar 1954 | A |
| 2673561 | Peterson, Jr. | Mar 1954 | A |
| 2688963 | Smith | Sep 1954 | A |
| 2688964 | Smith | Sep 1954 | A |
| 2690179 | Fox | Sep 1954 | A |
| 2717598 | Krasno | Sep 1955 | A |
| 2805662 | Lawshe et al. | Sep 1957 | A |
| 2911972 | Elinger | Nov 1959 | A |
| 2935067 | Bouet | May 1960 | A |
| 2950717 | Bonet | Aug 1960 | A |
| 3155281 | Stracey | Nov 1964 | A |
| 3161194 | Chapman | Dec 1964 | A |
| 3161195 | Taylor et al. | Dec 1964 | A |
| 3172577 | Hartung | Mar 1965 | A |
| 3190619 | Penney et al. | Jun 1965 | A |
| 3231139 | Bouet | Jan 1966 | A |
| 3301293 | Santelli | Jan 1967 | A |
| 3340869 | Bane | Sep 1967 | A |
| 3390821 | Mullan | Jul 1968 | A |
| 3411503 | Santomieri | Nov 1968 | A |
| 3442424 | Prussin et al. | May 1969 | A |
| 3471058 | Latham et al. | Oct 1969 | A |
| 3473524 | Drewe | Oct 1969 | A |
| 3474844 | Lindstrom et al. | Oct 1969 | A |
| 3506163 | Rauh et al. | Apr 1970 | A |
| 3557788 | Swartz | Jan 1971 | A |
| 3613963 | Berkmuller | Oct 1971 | A |
| 3618846 | Poli | Nov 1971 | A |
| 3826409 | Chilcoate | Jul 1974 | A |
| 3873003 | Seiferth et al. | Mar 1975 | A |
| 3938514 | Boucher | Feb 1976 | A |
| 4035461 | Korth | Jul 1977 | A |
| 4044836 | Martin et al. | Aug 1977 | A |
| 4064879 | Leibinsohn | Dec 1977 | A |
| 4066080 | Sneider | Jan 1978 | A |
| 4131217 | Sandegren | Dec 1978 | A |
| 4136802 | Mascia et al. | Jan 1979 | A |
| 4171698 | Genese | Oct 1979 | A |
| 4349129 | Amneus | Sep 1982 | A |
| 4392491 | Takasugi et al. | Jul 1983 | A |
| 4411656 | Cornett, III | Oct 1983 | A |
| 4526296 | Berger et al. | Jul 1985 | A |
| 4753638 | Peters | Jun 1988 | A |
| 4773458 | Touzani | Sep 1988 | A |
| 4850807 | Frantz | Jul 1989 | A |
| 5000739 | Kulisz et al. | Mar 1991 | A |
| 5201438 | Norwood | Apr 1993 | A |
| 5209372 | Norwood | May 1993 | A |
| 5236204 | Hempel | Aug 1993 | A |
| 5238150 | Williams | Aug 1993 | A |
| 5240130 | Osbakk | Aug 1993 | A |
| 5242422 | Schneberger et al. | Sep 1993 | A |
| 5269428 | Gilbert | Dec 1993 | A |
| 5333761 | Davis et al. | Aug 1994 | A |
| 5353961 | Debush | Oct 1994 | A |
| 5370250 | Gilbert | Dec 1994 | A |
| 5383858 | Reilly et al. | Jan 1995 | A |
| 5397157 | Hempel et al. | Mar 1995 | A |
| 5573129 | Nagata et al. | Nov 1996 | A |
| 5584413 | Jung | Dec 1996 | A |
| 5592948 | Gatten | Jan 1997 | A |
| 5609580 | Kwiatkowski et al. | Mar 1997 | A |
| 5615791 | Vatelot et al. | Apr 1997 | A |
| 5638995 | Mazda | Jun 1997 | A |
| 5683369 | Tsukada | Nov 1997 | A |
| 5758789 | Shin et al. | Jun 1998 | A |
| 5794107 | Russell | Aug 1998 | A |
| 5827233 | Futagawa et al. | Oct 1998 | A |
| 5836922 | Hansen et al. | Nov 1998 | A |
| 5873861 | Hitchins et al. | Feb 1999 | A |
| 5899889 | Futagawa et al. | May 1999 | A |
| RE36377 | Gilbert | Nov 1999 | E |
| 5979326 | Ohinata | Nov 1999 | A |
| 6054194 | Kane | Apr 2000 | A |
| 6062437 | Mascitelli | May 2000 | A |
| 6077252 | Siegel | Jun 2000 | A |
| 6105815 | Mazda | Aug 2000 | A |
| 6142976 | Kubo | Nov 2000 | A |
| 6216915 | Harman et al. | Apr 2001 | B1 |
| 6224577 | Dedola et al. | May 2001 | B1 |
| 6250505 | Petit | Jun 2001 | B1 |
| 6315761 | Shcherbina et al. | Nov 2001 | B1 |
| 6319235 | Yoshino | Nov 2001 | B1 |
| 6322535 | Hitchins et al. | Nov 2001 | B1 |
| 6332876 | Poynter et al. | Dec 2001 | B1 |
| 6485471 | Zivitz et al. | Nov 2002 | B1 |
| 6558358 | Rosoff et al. | May 2003 | B2 |
| 6578738 | Keller | Jun 2003 | B1 |
| 6620134 | Trombley, III et al. | Sep 2003 | B1 |
| 6634524 | Helmenstein | Oct 2003 | B1 |
| 6652489 | Trocki et al. | Nov 2003 | B2 |
| 6702143 | Wang | Mar 2004 | B2 |
| 6773417 | Fitzgibbons et al. | Aug 2004 | B2 |
| 6840164 | Eastman | Jan 2005 | B2 |
| 6866039 | Wright et al. | Mar 2005 | B1 |
| 6869419 | Dragan et al. | Mar 2005 | B2 |
| RE38770 | Gilbert | Aug 2005 | E |
| 7004213 | Hansen | Feb 2006 | B2 |
| 7011650 | Rosoff et al. | Mar 2006 | B2 |
| 7192549 | Hansen | Mar 2007 | B2 |
| 7250039 | Fitzgerald | Jul 2007 | B2 |
| 7309463 | Hansen | Dec 2007 | B2 |
| 7513378 | Mori et al. | Apr 2009 | B2 |
| 7553294 | Lazzaro et al. | Jun 2009 | B2 |
| 7604623 | Brunner et al. | Oct 2009 | B2 |
| 7666169 | Cowan et al. | Feb 2010 | B2 |
| 7802691 | Musalek et al. | Sep 2010 | B2 |
| 9173995 | Tucker et al. | Nov 2015 | B1 |
| 9180252 | Gelblum et al. | Nov 2015 | B2 |
| 9199033 | Cowan et al. | Dec 2015 | B1 |
| 9474857 | Riley et al. | Oct 2016 | B2 |
| 10105491 | Gelblum et al. | Dec 2018 | B2 |
| 10583256 | Berry | Mar 2020 | B2 |
| 20040249344 | Nemoto et al. | Dec 2004 | A1 |
| 20090112087 | Fago | Apr 2009 | A1 |
| 20100091361 | Yuuki | Apr 2010 | A1 |
| 20120020911 | Seliktar et al. | Jan 2012 | A1 |
| 20120209111 | Cowan et al. | Aug 2012 | A1 |
| 20120253291 | Ivosevic et al. | Oct 2012 | A1 |
| 20130023048 | Kim et al. | Jan 2013 | A1 |
| 20130030291 | Lewis | Jan 2013 | A1 |
| 20130211248 | Cowan et al. | Aug 2013 | A1 |
| 20130281940 | Gelblum | Oct 2013 | A1 |
| 20170035974 | Berry et al. | Feb 2017 | A1 |
| Number | Date | Country |
|---|---|---|
| 1086661 | Mar 2001 | EP |
| 2098258 | Sep 2009 | EP |
| 3057648 | Aug 2016 | EP |
| 1288915 | Mar 1962 | FR |
| 2214819 | Sep 1989 | GB |
| 2374143 | Oct 2002 | GB |
| 9221391 | Dec 1992 | WO |
| 9707841 | Mar 1997 | WO |
| 0204049 | Jan 2002 | WO |
| 2010004206 | Jan 2010 | WO |
| 2010014654 | Feb 2010 | WO |
| 2012061140 | May 2012 | WO |
| 2012155035 | Nov 2012 | WO |
| 2014027009 | Feb 2014 | WO |
| 2015058088 | Apr 2015 | WO |
| 2015066506 | May 2015 | WO |
| 2015164783 | Oct 2015 | WO |
| 2016058946 | Apr 2016 | WO |
| 2016069711 | May 2016 | WO |
| 2016069714 | May 2016 | WO |
| 2016172467 | Oct 2016 | WO |
| Entry |
|---|
| “International Search Report and Written Opinion from PCT/US2016/028824”, dated Jul. 27, 2016. |
| “International Preliminary Report on Patentability with Written Opinion from PCT/US2015/027582”, dated Nov. 3, 2016. |
| “International Search Report from PCT/US2015/027582”, dated Jul. 28, 2015. |
| “International Search Report and Written Opinion from PCT Application No. PCT/US2019/016621”, dated Apr. 18, 2019. |
| “Extended European Search Report from EP Application No. 15783517”, dated Nov. 8, 2017. |
| “International Preliminary Report on Patentability, International Search Report and Written Opinion from PCT Application No. PCT/US2016/028824”, dated Nov. 2, 2017. |
| Number | Date | Country | |
|---|---|---|---|
| 20180161496 A1 | Jun 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62257053 | Nov 2015 | US | |
| 62152511 | Apr 2015 | US |
