Patent Application
20210361875
The present disclosure is related to containers and syringes for use in the medical field and, more particularly, to a rolling diaphragm-type container and/or syringe having a flexible sidewall with a texturized inner surface that rolls upon itself when acted upon by a piston for selectively filling the syringe with a fluid and discharging the fluid from the syringe. The present disclosure is also directed to methods, features, and apparatus for texturizing the inner surface of the flexible sidewall and/or an injection molded preform.
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 solution of contrast media for imaging procedures (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 accurately deliver preset amounts of fluid at a preset pressure and/or flow rate.
Typically, powered injectors have one or more drive members, such as pistons, that connect to a syringe plunger within a 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 along a longitudinal axis of the barrel to draw fluid into the syringe barrel or deliver the fluid from the syringe barrel, respectively.
Many syringes used in the medical field are typically disposable and are discarded after one use or a limited number of uses. Although disposable syringes are typically made by mass production methods such as injection molding, these disposable syringes may be relatively expensive due to the overall number of imaging procedures performed at an imaging facility, the materials, precision, and volume and weigh of raw materials involved in their manufacture, and economic costs associated with packaging, shipping (volume and weight), storage, and disposal costs associated with conventional syringes. Accordingly, it remains desirable to develop improved designs of syringes to facilitate injection procedures with lower associated costs.
The present disclosure generally relates to rolling diaphragm containers, such as rolling diaphragm syringes having a flexible sidewall that rolls upon itself when acted upon by a piston such that an outer surface of the sidewall rolls in a radially inward direction as the piston is advanced from a proximal end to a distal end of the rolling diaphragm syringe and unrolls in a radially outward direction as the piston is retracted from the distal end to the proximal end, wherein at least a portion of an inner surface of the flexible sidewall comprises at least one surface texturization feature. According to various embodiments, the at least one surface texturization feature may result in at least one of a reduction the coefficient of friction, such as for surface to surface kinetic friction, between two portions of an inner surface of flexible sidewall of a rolling diaphragm syringe as the surfaces move relative to each other, a reduction of audible noise as the two portions of the inner surface move relative to each other, and a decrease in the volume of air entrapped between the rolled inner surfaces of the rolling diaphragm syringe. One further benefit is the reduction of particulate generation during the rolling/unrolling processes due to the reduction of the frictional forces between the two portions of the inner surface as they slide over or move relative to one another.
According to a first embodiment, the present disclosure provides a rolling diaphragm syringe for receiving a medical fluid therein. The rolling diaphragm syringe may comprise a closed proximal end wall for releasably engaging a piston of a fluid injector, a distal end having a neck and a fluid outlet, a flexible sidewall extending between the proximal end wall and the distal end, wherein the flexible sidewall rolls upon itself when acted upon by the piston such that the outer surface of the flexible sidewall rolls in a radially inward direction as the piston is advanced from the proximal end to the distal end and unrolls in a radially outward direction as the piston is retracted from the distal end to the proximal end, and at least one surface texturization feature on at least a portion of an inner surface of the flexible sidewall.
The rolling diaphragm syringe may be made from a medical grade polymer, such as, a medical grade polyethylene terephthalate (PET). The at least one surface texturization feature may reduce the coefficient of friction (μ) between contacting portions of the inner surface of the flexible sidewall as it is rolled and/or unrolled and the contacting portions move relative to one another. In certain embodiments, the coefficient of friction (μ) between the contacting portions of the inner surface of the flexible sidewall having the at least one surface texturization feature may range from 0.10 to 2.30 as the flexible sidewall is rolled or unrolled. In various embodiments, the at least one surface texturization feature may maintain a fluid pathway between parallel inner surfaces of the at least partially rolled rolling diaphragm syringe to allow air to escape from between the parallel inner surfaces during a rolling or unrolling process.
The at least one surface texturization feature may be selected from a group of texture pattern consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of dimpled protrusions extending from the inner surface of the flexible sidewall, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof.
According to various aspects, the at least one surface texturization feature may be a plurality of longitudinal ribs. The plurality of longitudinal ribs may be uniformly or non-uniformly arranged around the inner surface of at least the flexible sidewall. In certain embodiments, the plurality of longitudinal ribs may extend to at least a portion of the proximal end wall and/or the distal conical portion of the rolling diaphragm. In other embodiments, the plurality of longitudinal ribs may extend only partially from the proximal end to the distal end or only partially from the distal end to the proximal end. In certain embodiments, at least a portion of the plurality of longitudinal ribs may extend for different lengths and/or at different regions along the longitudinal axis along the inner surface of the flexible sidewall of the rolling diaphragm syringe. In other embodiments, the plurality of longitudinal ribs may have different heights and/or widths along the lengths of the longitudinal axis of the longitudinal rib.
According to other embodiments, the at least one surface texturization feature may be a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface of the flexible sidewall extending along at least a portion of the longitudinal axis. In certain embodiments, the plurality of spiral ribs may extend to at least a portion of the proximal end wall and/or the distal conical portion of the rolling diaphragm. In other embodiments, the plurality of spiral ribs may extend only partially from the proximal end to the distal end or only partially from the distal end to the proximal end. In certain embodiments, at least a portion of the plurality of spiral ribs may extend for different lengths and/or at different regions along the circumference and/or longitudinal axis of the inner surface of the flexible sidewall of the rolling diaphragm syringe. In other embodiments, the plurality of spiral ribs may have different heights and/or widths along the circumference and/or longitudinal axis of the inner surface of the flexible sidewall.
Other embodiments of the present disclosure may be directed to a preform for blow-molding, such as stretch blow-molding, a rolling diaphragm syringe. The preform may be made from an injection molding process and may be made of any suitable medical grade plastic. The preform may comprise a closed proximal end portion having a piston engagement feature configured for allowing releasable engagement between the rolling diaphragm syringe and a piston of a fluid injector, a distal end having a fluid outlet, a sidewall having an inner surface and an outer surface, and at least one preform texturization feature on at least a portion of one of the inner surface and/or the outer surface of the sidewall, wherein the at least one preform texturization feature forms an at least one surface texturization feature on at least a portion of an inner surface of a sidewall of the rolling diaphragm syringe, for example during the blow-molding process. The at least one preform texturization feature may comprise a plurality of preform longitudinal ribs on at least a portion of the inner surface of the preform sidewall, wherein the plurality of preform longitudinal ribs form a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the inner surface of the sidewall of the rolling diaphragm syringe. In certain embodiments, the at least one preform texturization feature may comprise a plurality of preform longitudinal ribs on at least a portion of the outer surface of the sidewall, wherein the plurality of preform longitudinal ribs form a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the outer surface of the sidewall of the rolling diaphragm syringe, and wherein the plurality of longitudinal ribs or the plurality of spiral ribs on at least a portion of the outer surface of the sidewall of the rolling diaphragm syringe are converted to a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the inner surface of the sidewall of the rolling diaphragm syringe during a blow-molding process.
According to various embodiments, the at least one preform texturization feature on at least the portion of one of the inner surface and/or the outer surface of the preform sidewall may be formed during an injection molding process using a mold having corresponding grooves on the core structure of the injection mold or the outer mold cavity of the injection mold. In certain embodiments, the at least one preform texturization feature may comprise a plurality of preform longitudinal ribs on at least a portion of the inner surface of the preform sidewall, wherein the plurality of preform longitudinal ribs are formed by etching or cutting a plurality of longitudinal grooves on the at least a portion of the inner surface of the sidewall during removing of an injection mold core structure having a corresponding plurality of groove etching or cutting members.
Still other embodiments of the present disclosure may be directed to methods for reducing friction, for example by reducing a coefficient of friction (μ), between the contacting portions of a rolled inner surface of the flexible sidewall of a rolling diaphragm syringe during a rolling and/or unrolling process. The methods may include texturizing at least a portion of the inner surface of the flexible sidewall with at least one surface texturization feature selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof. According to certain embodiments, texturizing at least a portion of the inner surface of the preform may comprise texturizing at least a portion of an inner surface of an injection molded preform and blow-molding the injection molded preform to provide a rolling diaphragm, such as a rolling diaphragm syringe configured from injecting a medical fluid for a medical procedure. The rolling diaphragm may be made from a medical grade PET. In certain embodiments, texturizing may include texturizing at least a portion of at least one of the two portions of the inner surface during a blow-molding process.
According to the various embodiments, reducing the friction between the contacting portions of the rolled inner surface of the flexible sidewall of the rolling diaphragm may reduce or eliminate audible noise, such as an undesired audible squeaking noise, during a rolling and/or an unrolling of the rolling diaphragm, for example as the opposing contacting surfaces of the rolled inner surfaces slide over each other when moved relative to each other. According to certain embodiments, the coefficient of friction (μ) between contacting portions of the rolled inner surface of the flexible sidewall having the at least one surface texturization feature as the flexible sidewall is rolled or unrolled may range from 0.10 to 2.30. The value of the reduction of the coefficient of friction (μ) may depend on the type and polymeric structure of the medical grade plastic, for example the type or structure of a medical grade PET.
In certain embodiments, texturizing at least a portion of at least one of the two portions of the inner surface of the blow-molded rolling diaphragm syringe comprises texturizing the at least a portion of at least one of the two portions of the inner surface during a rolling process when a flexible sidewall of the blow-molded rolling diaphragm syringe rolls upon itself when acted upon by a piston such that an outer surface of the sidewall is rolled in a radially inward direction as the piston is advanced from a proximal end to a distal end of the blow-molded rolling diaphragm syringe
Still other embodiments of the present disclosure may be directed to methods for removing entrapped air between contacting portions of a rolled inner surface of a flexible sidewall of a rolling diaphragm. The method comprises texturizing at least a portion of the inner surface with at least one surface texturization feature selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof. The at least one surface texturization feature provides a fluid path for at least a portion of any entrapped air to escape from between the contacting portions of a rolled inner surface of the flexible sidewall of the rolling diaphragm. According to various embodiment, the at least one surface texturization feature may also reduce a coefficient of friction (μ) between contacting portions of the rolled inner surface of the flexible sidewall having the at least one surface texturization feature as the flexible sidewall is rolled or unrolled to a range from 0.10 to 2.30.
Still other embodiments of the present disclosure are directed to methods of forming rolling diaphragm syringes having at least one surface texturization feature, such as by blow-molding preforms having surface texturization features on at least a portion of a sidewall surface thereof. Various embodiments are directed toward molded preforms that are blow-molded to provide the rolling diaphragm syringes having at least one surface texturization feature on at least a portion of a sidewall thereof.
According to various embodiment, the present disclosure provides a rolling diaphragm syringe for receiving a medical fluid therein, the rolling diaphragm syringe comprising: a proximal end comprising a dome-shaped end wall configured to receive and engage a piston of a fluid injector, an annular portion extending proximally from a periphery of the end wall having a substantially cylindrical sidewall, and an outwardly flared portion extending radially and distally from the substantially cylindrical sidewall; an open distal end comprising a discharge neck; a flexible sidewall extending between the outwardly flared portion of the proximal end and the distal end along a longitudinal axis; and a piston engagement portion protruding proximally from a central portion of the end wall configured for engagement with the piston of the fluid injector, wherein the sidewall is flexible and rolls upon itself when acted upon by the piston such that an outer surface of the sidewall is rolled in a radially inward direction as the piston is advanced from the proximal end to the distal end, and wherein at least a portion of an inner surface of the flexible sidewall comprises at least one surface texturization feature.
In certain embodiments, the at least one surface texturization feature is selected from the group consisting of a plurality of uniform or non-uniform axial ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof.
Various aspects of the system and method for pressure calibration of the fluid injector are disclosed in one or more of the following numbered clauses:
Claus 1: A rolling diaphragm syringe for receiving a medical fluid therein, the rolling diaphragm syringe comprising: a closed proximal end wall for releasably engaging a piston of a fluid injector; a distal end having a neck and a fluid outlet; a flexible sidewall extending between the proximal end wall and the distal end, wherein the flexible sidewall rolls upon itself when acted upon by the piston such that the outer surface of the flexible sidewall rolls in a radially inward direction as the piston is advanced from the proximal end to the distal end and unrolls in a radially outward direction as the piston is retracted from the distal end to the proximal end; and at least one surface texturization feature on at least a portion of an inner surface of the flexible sidewall.
Clause 2: The rolling diaphragm syringe of clause 1, wherein the rolling diaphragm syringe is made from a medical grade polyethylene terephthalate (PET).
Claus 3: The rolling diaphragm syringe of clause 1 or 2, wherein the at least one surface texturization feature reduces the coefficient of friction (μ) between contacting portions of the inner surface of the flexible sidewall as it is rolled or unrolled.
Clause 4: The rolling diaphragm syringe of clause 2 or 3, wherein the coefficient of friction (μ) between contacting portions of the inner surface of the flexible sidewall having the at least one surface texturization feature as the flexible sidewall is rolled or unrolled ranges from 0.10 to 2.30.
Clause 5: The rolling diaphragm syringe of any of clauses 1 to 4, wherein the at least one surface texturization feature is selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof.
Clause 6: The rolling diaphragm syringe of any of clauses 1 to 4, wherein the at least one surface texturization feature is a plurality of longitudinal ribs.
Clause 7: The rolling diaphragm syringe of clause 6, wherein the plurality of longitudinal ribs are uniformly or non-uniformly arranged circumferentially around the inner surface.
Clause 8: The rolling diaphragm syringe of clause 6, wherein the plurality of longitudinal ribs extend only partially from the proximal end to the distal end.
Clause 9: The rolling diaphragm syringe of clause 6, wherein at least a portion of the plurality of longitudinal ribs extend for different lengths and at different regions along the longitudinal axis.
Clause 10: The rolling diaphragm syringe of clause 6, wherein the plurality of longitudinal ribs have different heights along a length of the longitudinal axis of the rib.
Clause 11: The rolling diaphragm syringe of any of clauses 1 to 4, wherein the at least one surface texturization feature is a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface extending along at least a portion of the longitudinal axis.
Clause 12: The rolling diaphragm syringe of any of clauses 1 to 11, wherein the at least one surface texturization feature maintains a fluid pathway between substantially parallel inner surfaces of the at least partially rolled rolling diaphragm syringe to allow air to escape from between the parallel inner surfaces during a rolling or unrolling process.
Clause 13: A preform for blow-molding a rolling diaphragm syringe, the preform comprising: a closed proximal end portion having a piston engagement feature configured for allowing releasable engagement between the rolling diaphragm syringe and a piston of a fluid injector; a distal end having a fluid outlet; a sidewall having an inner surface and an outer surface; and at least one preform texturization feature on at least a portion of one of the inner surface and the outer surface of the sidewall, wherein the at least one preform texturization feature forms an at least one surface texturization feature on at least a portion of an inner surface of a sidewall of the rolling diaphragm syringe.
Clause 14: The preform of clause 13, wherein the at least one preform texturization feature comprises a plurality of preform longitudinal ribs on at least a portion of the inner surface of the sidewall, wherein the plurality of preform longitudinal ribs form a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the inner surface of the sidewall of the rolling diaphragm syringe.
Clause 15: The preform of clause 13, wherein the at least one preform texturization feature comprises a plurality of preform longitudinal ribs on at least a portion of the outer surface of the sidewall, wherein the plurality of preform longitudinal ribs form a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the outer surface of the sidewall of the rolling diaphragm syringe, and wherein the plurality of longitudinal ribs or the plurality of spiral ribs on at least a portion of the outer surface of the sidewall of the rolling diaphragm syringe are converted to a plurality of longitudinal ribs or a plurality of spiral ribs on at least a portion of the inner surface of the sidewall of the rolling diaphragm syringe during a blow-molding process.
Clause 16: The preform of any of clauses 13 to 15, wherein the at least one preform texturization feature on at least the portion of one or both of the inner surface and the outer surface of the sidewall are formed during an injection molding process using a mold having corresponding grooves on the core structure or the outer mold cavity.
Clause 17: The preform of any of clauses 13 to 15, the at least one preform texturization feature comprises a plurality of preform longitudinal ribs on at least a portion of the inner surface of the sidewall, wherein the plurality of preform longitudinal ribs are formed by etching a plurality of longitudinal grooves on the at least a portion of the inner surface of the sidewall during removing of an injection mold core structure having a corresponding plurality of groove etching members.
Clause 18: A method for reducing friction between contacting portions a rolled inner surface of a flexible sidewall of a rolling diaphragm, the method comprising: texturizing at least a portion of the inner surface of the flexible sidewall with at least one surface texturization feature selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof.
Clause 19: The method of clause 18, wherein texturizing at least a portion of the inner surface comprises: texturizing at least a portion of an inner surface of an injection molded preform; and blow-molding the injection molded preform to provide the rolling diaphragm.
Clause 20: The method of clause 18 or 19, wherein the rolling diaphragm is a rolling diaphragm syringe configured for injecting a medical fluid for a medical procedure.
Clause 21: The method of any of clauses 18 to 20, wherein the rolling diaphragm is made from a medical grade PET.
Clause 22: The method of any of clauses 18 to 21, wherein reducing the friction between the contacting portions of the rolled inner surface of the flexible sidewall of the rolling diaphragm reduces or eliminates an audible squeak during a rolling or an unrolling of the rolling diaphragm.
Clause 23: The method of any of clauses 18 to 22, wherein a coefficient of friction (μ) between contacting portions of the rolled inner surface of the flexible sidewall having the at least one surface texturization feature as the flexible sidewall is rolled or unrolled ranges from 0.10 to 2.30.
Clause 24: The method for removing entrapped air between a rolled inner surface of a flexible sidewall of a rolling diaphragm, the method comprising: texturizing at least a portion of the inner surface with at least one surface texturization feature selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof, wherein the at least one surface texturization feature provides a fluid path for the entrapped air to escape between the rolled inner surface of the flexible sidewall of the rolling diaphragm.
Clause 25: The method of clause 24, wherein the at least one surface texturization feature reduces a coefficient of friction (μ) between contacting portions of the rolled inner surface of the flexible sidewall having the at least one surface texturization feature as the flexible sidewall is rolled or unrolled to a range from 0.10 to 2.30.
Other embodiments of the present disclosure will become apparent to one of skill in the art reading the disclosure herein including the one or more Figures herewith.
The attached Drawings illustrate various features and non-limiting embodiments the rolling diaphragm syringes and preforms according to certain embodiments of the present disclosure.
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 the injector. The term “distal” refers to a portion of a syringe, a pressure jacket, or a rolling diaphragm syringe farthest away from the injector when the syringe, the pressure jacket, or the 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 the syringe, the pressure jacket, or the 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 the syringe, the pressure jacket, or the rolling diaphragm syringe. The term “flexible”, when used in connection with a rolling diaphragm syringe, means that at least a portion of the rolling diaphragm syringe, such as a sidewall of the 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 portion of the rolling diaphragm syringe, such as a proximal end portion of the rolling diaphragm syringe, to bend approximately 180 relative to a second portion of the 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. As used herein, the term “substantially” means to within plus or minus 5% variation. For example, two surfaces denoted as “substantially parallel” can be up to plus or minus 5 degrees from parallel. As used herein, the term “rib” when references in relation to a surface texturization feature may also include a portion of an inner sidewall located between two adjacent radial grooves in the sidewall. For example, a rib may be formed by material projecting in a radially inward or radially outward direction relative to the sidewall or may be formed by the material of the sidewall that is located between two grooves that radially project into the material of the sidewall. As used herein, the process of blow-molding may include stretch blow-molding where a stretch rod in utilized during the blow-molding process.
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 a syringe configured as a rolling diaphragm syringe 10 configured to be connected to a syringe rolling apparatus or a fluid injector. For example, the syringe 10 may be configured to be received within a pressure jacket mounted to the apparatus or injector for providing radial and axial support for the syringe 10 during rolling or during an injection. Examples of rolling diaphragm syringes suitable for incorporation of at least one texturization feature according to the present disclosure are described in PCT International Publication Nos. WO 2015/164783; WO 2016/172467; and WO 20018/075386, and in U.S. Provisional Application Ser. No. 62/632,026, the disclosures of each of which are incorporated herein in their entireties by this reference.
With reference to
In some examples, the outer diameter OD may be dimensioned such that the rolling diaphragm syringe 10 fits within an interior space defined by the throughbore and an inner surface of a pressure jacket (not shown) of a fluid injector. In one aspect, the rolling diaphragm syringe 10 may fit snuggly within the pressure jacket such that the outer surface 22 of the rolling diaphragm syringe 10 abuts the inner surface of the walls of the pressure jacket. In another aspect, the rolling diaphragm syringe 10 fits loosely within the pressure jacket such that there is a gap between at least a portion of the outer surface 22 of the rolling diaphragm syringe 10 and the inner surface of the pressure jacket. The rolling diaphragm syringe 10 may be expanded under pressure such that the outer surface 22 of the rolling diaphragm syringe 10 abuts or contacts the inner surface of the pressure jacket.
Referring to
The rolling diaphragm syringe 10 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, polypropylene random copolymer, polypropylene impact copolymer, polypropylene homopolymer, polypropylene, polyethylene terephthalate (PET), POM, ABS, HPDE, nylon, cyclic olefin copolymer, multilayer polypropylene, polycarbonate, ethylene vinyl acetate, polyethylene, and the like. The material of the rolling diaphragm syringe 10 is desirably selected to meet the required tensile and planar stress requirements, water vapor transmission, and chemical/biological compatibility.
According to specific embodiments, the syringe may be polyethylene terephthalate (PET) or other medical graph polymer, such as a medical grade polymer selected from EASTAR™ MN021 and EASTAR™ MN052, commercially available from Eastman Chemical Co. One feature of PET and other polymeric materials is that when two smooth surfaces of PET or other polymeric material slide past and over each other, the coefficient of friction (μ) may be significant and can result in an increased force requirement to overcome the static friction between the two surfaces so that they can slide easily relative to one another. An additional feature may be that the two surfaces emit audible noise, such as a squeak or other high pitched noise, as the surfaces slide relative to each other due to kinetic friction between the surfaces. This issue cannot be solved by simply increasing the distance between the two surfaces, since when the distance between the two surfaces becomes too large, the flexible sidewalls may pleat or form creases during rolling and unrolling. For unrolling, this issue may become more prevalent since a partial vacuum if formed in the syringe interior which causes the sidewall to bow inwardly, further increasing the likelihood of pleating. For various embodiments of the rolling diaphragm syringe 10, two portions of the inner surface 24 of the syringe 10 must roll and slide over each other while in abutting contact as the syringe is rolled and unrolled, for example during an injection procedure. For example, as illustrated in
In some examples, the rolling diaphragm syringe 10 may be reusable, meaning that the syringe 10 can be rolled and unrolled multiple times before being disposed of or recycled. For example, the rolling diaphragm syringe 10 can be filled as described above, rolled to deliver fluid contained therein to the patient, and then unrolled and re-filled several times to deliver additional doses of fluid to the patient. Alternatively, when utilized with a single-patient fluid path with appropriate check valves and connectors to prevent cross-contamination between patients, the rolling diaphragm syringe 10 may be used as a multi-patient syringe, with the single-patient portion of the fluid path being disposed of in between injection procedures. Alternatively, the rolling diaphragm syringe 10 may be a single-use component that is disposed of after each patient use.
According to various embodiments of the present disclosure, the rolling diaphragm syringe 10 described herein may comprise at least one surface texturization feature on at least a portion of an inner surface 24 of the flexible sidewall 20 of the rolling diaphragm syringe 10. The at least one surface texturization feature is selected from the group consisting of a plurality of uniform or non-uniform longitudinal ribs, a plurality of uniform or non-uniform ribs having a spiral configuration around a circumference of the inner surface, a plurality of ribs having a non-uniform pattern on the inner surface, a plurality of flat surfaces, a uniform or non-uniform roughened surface, a plurality of particulates or beads embedded in the sidewall, or any combinations thereof. As used herein the term “uniform” means that each surface texturization feature has substantially the same shape over the entirety of the surface texturization feature, for example, a uniform longitudinal rib will have substantially the same height, length, and/or width. As used herein the term “non-uniform” means that at least one feature of a surface texturization feature has a different shape or size at at least a portion of the texturization feature, for example, a non-uniform longitudinal rib may differ in height, width, and/or length at at least a portion of the rib. Non-limiting examples of non-uniform longitudinal ribs include, for example, ribs extending along only a portion of the syringe sidewall, ribs that have different heights (e.g., extend a different radial distance into the interior volume of the syringe) along the length of the rib, ribs that have different widths (e.g., are wider at one portion than at another) along the length of the rib, ribs that may have gaps along the length of the rib, etc. Non-uniformity of the surface texturization feature may provide a benefit, such as allowing the preform or syringe to be more readily removed from the injection or blow mold, respectively by providing a suitable draft angle for mold removal and/or preventing/limiting undercuts in the molding process.
In some examples, the rolling diagraph syringe 10 is formed from a preform 800 (see e.g.,
According to certain embodiments, described in detail herein, the inner surface of the preform 800 may be texturized prior to the blow-molding process. For example, at least one preform texturization feature may be included onto at least a portion of an inner surface 824 and/or an outer surface 822 of the preform 800 during an injection molding process (see
According to certain embodiments, following a stretch blow-molding process, the syringe 10 can be structurally modified by the initial rolling action in which, as described herein, an unfilled syringe (e.g., a syringe 10 that does not contain a medical solution) is contacted by a piston and rolled to mold or reform certain structural features. A syringe 10, after initial rolling in a contracted or rolled state, is shown in
Following the initial rolling, the syringe 10 having the at least one texturization feature may be stored and/or shipped to customers in the compressed or rolled state. Providing the rolling diaphragm syringe 10 in the compressed or rolled configuration provides economic benefits by reducing space required for storing, transporting, and disposal of manufactured syringes. Costs are reduced since the rolling diaphragm syringes 10 disclosed herein use less raw materials for manufacture and weigh less than similarly sized conventional disposable syringes known in the art and used with fluid injectors. When ready for use in a fluid injector, the syringe 10 is inserted into a pressure jacket and engaged with a piston of a fluid injector. The syringe 10 is at least unrolled by proximal retraction of a piston of the injector to draw a desired volume of fluid into the syringe interior. The fluid-filled unrolled syringe 10, shown in
With continued reference to
In some examples, the proximal and distal ends 16, 12 of the syringe 10 may be thicker than the flexible sidewall 20 of the syringe 10 to accommodate forces associated with loading and delivering a fluid under pressure. According to these embodiments, transition zones 26 between the thicker distal or proximal ends and the thinner sidewall 20 may be short in length relative to the sidewall 20, which may be accomplished during the stretch blow-molding process. For example, as shown in
In some examples, the closed end wall 18 may have a concave, dome-shaped structure to facilitate initiation of the inversion or rolling of the sidewall 20 and/or to provide a receiving space or pocket to receive a distal end of a piston. Further, the end wall 18 may have a non-uniform thickness, for example in a radial direction extending from a central longitudinal axis of the rolling diaphragm syringe 10. For example, at least a portion of the end wall 18 may be thicker near central portion 28 and thinner near the connection with the sidewall 20. The closed end wall 18 may be shaped to interface directly with a piston of a fluid injector. In particular aspects, the piston may be shaped to substantially match the shape of the closed end wall 18 or, alternatively and as described in detail herein, pressure from the piston as it is moved distally may conform the end wall 18 and/or other portions of the proximal end 16 of the syringe 10 to substantially match a shape of the piston, for example during the initiation of the rolling process.
In various embodiments, the end wall 18 may have a central portion 28 including a piston engagement portion 30 extending proximally therefrom, such as at an approximate midpoint of the central portion 28. In some aspects, a distal most end of the central portion 28 may be substantially flat over a partial radius of the closed end wall 18.
The piston engagement portion 30 may be configured for engagement with an engagement mechanism on a piston of the fluid injector (see, e.g., the disclosure of PCT Published Application Nos. WO 2015/164783; WO 2016/172467; and WO 20018/075386). In some aspects, the piston engagement portion 30 may include a stem 34 having a first end 36 connected at the central portion 28 and a second end 38 extending proximally from the first end 36. In certain embodiments, the stem 34 may include a protrusion configured for interacting with one or more engagement pins or surfaces of an engagement mechanism of a fluid injector that moves radially inward and outward to engage and disengage the stem 34 of the rolling diaphragm syringe 10.
With continued reference to
A fluid injection or fluid delivery system includes a fluid injector, such as an automated or powered fluid injector, adapted to interface with one or more rolling diaphragm syringes 10 and pressure jackets with each syringe 10. Each of the syringes 10 may be independently filled with a medical fluid, such as an imaging contrast media, saline solution, or any desired medical fluid. The injector may be used during a medical procedure to inject the medical fluid (e.g., contrast media or saline solution) into the body of a patient by driving a piston into the at least one rolling diaphragm syringe 10 to cause the syringe 10 to roll in a distal direction to expel fluid therefrom. The piston can be sized to engage the end wall 18 of the syringe 10. The injector may be a multi-syringe injector, wherein two or more rolling diaphragm syringes 10 with corresponding pressure jackets are oriented in a side-by-side or other relationship and include corresponding pistons actuated by a linear actuator of the injector. In aspects with two rolling diaphragm syringes 10 and pressure jackets arranged in a side-by-side relationship and filled with two different medical fluids, the injector may be configured to deliver fluid from one or both of the rolling diaphragm syringes 10. In certain embodiments, the fluid injector may be configured to interface with either rolling diaphragm syringes, conventional plunger-containing syringes, or a combination of one or more rolling diaphragm syringes and one or more conventional plunger-containing syringes.
The injector may be enclosed within a housing formed from a suitable structural material, such as plastic or metal. The housing may be of various shapes and sizes depending on the desired application. For example, the injector 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. At least one fluid path set may be fluidly connected with a discharge neck 14 of the syringe(s) 10 for delivering medical fluid from the at least one rolling diaphragm syringe 10 through tubing to a catheter, needle, or other fluid delivery connection (not shown) inserted into a patient at a vascular access site. The tubing may be connected to the discharge neck by a unitary or removable cap, such as a cap described in PCT International Application No. PCT/US2018/050640, the disclosure of which is incorporated herein by this reference. Fluid flow into and from the syringe(s) 10 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 rolling diaphragm syringes 10 is disclosed in U.S. Pat. No. 5,383,858 which is incorporated by reference in its entirety. Other examples of relevant multi-fluid delivery systems that may be used or modified for use with the present system are found in U.S. Pat. Nos. 7,553,294 and 7,666,169; International Patent Application Publication Nos. WO 2012/155035 and 2015/164783; and United States Patent Application Publication No. 2014/0027009, the disclosures of which are incorporated herein by reference.
In use, syringe(s) 10 may be provided to a medical facility in the compressed or rolled state as shown in
According to certain aspects, one focus of the present disclosure is to reduce or remove an undesired audible noise (e.g., a squeak) associated with rolling/unrolling of the rolling diaphragm syringe 10 upon itself. One solution according to various embodiments herein is to add at least one surface texturization feature to at least a portion of an inner surface 24 of the rolling diaphragm syringe 10. It has been observed that when unrolling the syringe 10 a slight vacuum is created within the syringe when fluid or air is drawn in causing the distal sides of the flexible sidewall 20, including the unrolled portion of the inner surface 24b to draw inwardly, thereby contacting and interfering with the rolled portion of the inner surface 24b as it is retracting. This results in surface area contact between the two portions of the inner surfaces 24a,24b that increases the frictional contact between the two portions of the inner surface 24a,24b as they slide over each other, requiring additional force to continue the unrolling/rolling process and has the additional undesired effect of causing audible noise in the form of a squeak as the plastic material, such as PET, rolls and the smooth PET inner surfaces 24a,24b slide relative to each other. This can also happen when there is a slight misalignment in the piston or the pressure jacket and even during the initial rolling process. The syringe may also squeak from the technician handling the syringe, for example as they are installing the syringe into the injector and causing the inner surfaces 24a,24b to contact. While this has no actual impact on the operation of the syringe, the technician may become concerned by the noise. One solution according to various embodiments herein is to impart some type of surface texture to the inner surface 24 of the syringe 10 to break up the surface area of contact between the smooth inner surfaces, resulting from the blow-molding process, which must roll across one another during the rolling or unrolling process. By adding at least one surface texturization feature to at least a portion of the inner surface 24, the contact surface area is reduced which reduces the coefficient of friction (μ) between the two surfaces 24a,24b and the energy to create the squeak. According to other embodiments, the friction force between the inner surfaces 24a,24b of the rolling diaphragm syringe 10 may be reduced, for example, by addition of a lubricant like a medical grade silicone to the inner surface 24, addition of a non-silicone lubricous coating such as for example TRIBOGLIDE to the inner surface 24, addition of a gas or liquid to physically or chemically etch or modify the inner surface of the syringe, or ensure the walls never touch through accurate alignment of the rolled surfaces, the pressure jacket and the injector piston.
According to various embodiments of the present disclosure, adding at least one texturization feature to at least a portion of the inside surface finish may be accomplished in multiple ways (including combinations of different ways). According to certain embodiments, texture may be added to a core portion of the injection mold during the molding (injection molding) of the preform 800 and the resulting texture may be transferred to the inner surface 824 of the preform 800 (see,
Various plastic materials, for example medical-grade plastics such as PET, may have a high coefficient of friction (μ) when two surfaces of the material slide across each other, for example during a rolling or unrolling process of a rolling diaphragm syringe made therefrom. For example, EASTAR™ MN021 medical grade PET may have a coefficient of friction of μ=2.07 and EASTAR™ MN052 medical grade PET may have a coefficient of friction of μ=0.81. According to various embodiments, the coefficient of friction (μ) for the inner surfaces 24 having at least one texturization feature, for example inner PET surfaces, may be reduced by 40% to 90%, or in other embodiments from 50% to 80%. The amount of reduction of the coefficient of friction may be dependent on the grade or structure of the polymeric material (e.g., PET), for example, the coefficient of friction of MN021 may be reduced by from 50% to 90% and the coefficient of friction for MN052 may be reduced by from 20% to 60%. According to various embodiments, addition of at least one texturization feature to at least a portion of an inner surface 24 of the flexible sidewall 20 of the rolling diaphragm syringe 10 may result in a coefficient of friction (μ) that ranges from 0.10 to 2.30 and in certain embodiments from 0.10 to 1.20 or even from 0.30 to 1.20. According to embodiments herein, this can be accomplished by adding at least one texturization feature to at least a portion of an inner surface 24 of the flexible sidewall 20 of the rolling diaphragm syringe 10 during at least one of a preform injection molding process to form the preform 800, a stretch blow-molding process of the preform 800 to form the syringe 10, a rolling process of the blow-molded rolling diaphragm syringe 10 or during two or more of these processes. The two inner surfaces 24a, 24b of the flexible sidewall 20 slide against each other when rolling and unrolling of the syringe 10, creating an undesired audible noise as they frictionally contact each other. In certain embodiments, when the coefficient of friction between the two inner surfaces 24a, 24b of the flexible sidewall 20 is reduced to less than or equal to 1.00, no audible squeak is heard by the user. While both rolling and unrolling the syringe creates noise (squeaks), more noise may be experienced during the unrolling process because there is usually a partial vacuum created as the end wall 30 is retracted, which causes the distal portion of the flexible sidewall to drawn in and create even more interference/contact between the two inner walls 24a, 24b.
One approach according to various embodiments includes adding at least one texturization feature to at least a portion of the inner surface 24 of the sidewall 20 of a blow-molded syringe 10. According to the process (refer to
According to certain embodiments, a plurality of longitudinal ribs may be added to the inner wall of the preform (e.g., 900, 1000, or 1100 of
In another embodiment, the plurality of uniform or non-uniform ribs may have a clockwise or counterclockwise spiral or helical pattern along the longitudinal axis of the preform 1200 (see
Various non-limiting embodiments of the rolling diaphragm syringes 10, the injection molded preforms 800, the structure of the core member for the injection molding process to form the preform 800, and processes to form embodiments of the at least one surface texturization feature will be described with reference to one or more of the accompanying drawings. The features of the syringes, preforms, and mold structures are not intended to be limited thereby.
With reference to
With reference to
According to certain embodiments, the plurality of ribbed surface texture features may extend to the proximal end wall 30 of the syringe 10. Adding ribbed texture lines to the base area of the syringe may increase the base inversion force (i.e., the force necessary to invert the contact end wall 30, for example during a retraction of the piston and end wall 30). Typically inversion of the concave end wall 30 is undesired as it results in error in volume and damage to the syringe which can potentially lead to creasing of the sidewall 20. The thickness and/or height of the textured rib features may vary directly with observed base inversion forces. According to other embodiments, a plurality of ribbed features may add additional beam strengthening to the flexible sidewall 20 to prevent volumetric shrinkage over time. For example, a plurality of longitudinal ribs may add longitudinal stiffness to the flexible sidewall 20. According to another example one or more spiral ribs around the circumference of the sidewall 20 may add stiffness to the wall to prevent volumetric shrinkage from bowing out or bowing in over time.
With reference to
With reference to
According to the various approaches described herein, the rolling diaphragm syringes having the at least one surface texturization feature thereon are typically formed via a stretch blow-molding process from an injection molded preform. In certain embodiments, at least one preform surface texturization feature may be initially molded one or imparted to the preform and then converted to the desired at least one surface texturization feature on an inner surface of the rolling diaphragm syringe. As the polymeric material expands and thins during the stretch blow-molding process, the size, depth, width, shape, relative position, and location of the at least one preform texturization feature must be selected to give the desired size, depth, width, shape, relative position, and location of the at least one texturization feature on the rolling diaphragm. The physical properties of the at least one surface texturization feature on the resulting syringe are chosen to provide the appropriate balance between having sufficient distance and low contact surface area between the distal and proximal regions of the inner surfaces of the sidewalls in the rolled configuration (resulting in undesired audible noise, entrapment of air between the inner surfaces, and strain on the injector motor) and not having too much distance where the sidewall and/or end wall portions of the syringe (increasing the chance that the syringe wall will buckle or crease during the rolling or unrolling process as the sidewalls move towards each other and overcome the hoop strength of the flexible sidewall). According to certain embodiments, the radial extension of the at least one surface texturization feature is selected so the distance between the inner surfaces of the sidewall of the syringe in the rolled configuration ranges from about 0.01 inches to about 0.06 inches. In other embodiments, the distance between the inner surfaces of the sidewall of the syringe in the rolled configuration ranges from about 0.02 inches to about 0.004 inches.
Various embodiments of the injection molded preform will now be described. With reference to
With reference to
According to various embodiments, injection mold core members may also be used to apply the at least one surface texturization feature to an inner surface 824 of a sidewall 820 of a preform 800 during the injection molding process. Core surface texturization features may be directly transferred to the inner surface 824 of the preform sidewall 820 during the injection molding. With reference to
With reference to
With reference to
With reference to
With reference to
According to still other embodiments, the core member may include at least one core member surface texturization feature such as a non-uniform surface that may be imparted to the preform 800 during an injection molding process. Considerations regarding the amount of draft necessary to remove the core member may be necessary. In certain embodiments, the core member may include a plurality of core member surface texturization features that may extend from an outer surface of the core during the injection molding but may be retractable to allow for removal of the core member from the interior of the formed preform.
According to still other embodiments, the plurality of surface texturization feature may be applied during the stretch blow-molding process, for example using the stretch rod to impart the at least one surface texturization feature. Referring to
Referring to
Referring to
In other embodiments, the plurality of surface texturization features on the inner surface of the rolling diaphragm may be imparted using a textured plunger in an initial rolling process. As described herein after blow-molding of the syringe, the end wall 30 of the syringe 10 (see, e.g.,
According to other embodiments, the preform may be molded with a plurality of fibers or particles formed from a material that has a higher glass transition temperature Tg than the preform polymer. As illustrated in
As described herein, the distance between the distal and proximal portions of the inner sidewall of the syringe may determine, at least in part, the coefficient of friction (μ) between the two sidewall surfaces. For example, with reference to
Referring now to
With reference to
With reference to
The following variables were examined and exhibited positive impact on the coefficient of friction (μ), audible squeak, and entrapped air reduction results. The rolling/unrolling process was broken into three phases: Phase 1 includes initial retraction of the plunger from 0 mL to about 60 mL; Phase 2 includes movement of the piston distally from 60 mL to about 10 mL to purge air from the syringe; and Phase 3 includes proximal retraction of the plunger from 10 mL to 150 mL to provide a fully filled syringe. Variables that exhibited no significant positive effect are not discussed.
Silicone—Silicone exhibited a significant improvement across all three categories including friction, squeak, and air entrapment results. Using silicone, the friction results were negligible, the squeak was non-existent, and the air rating showed significant improvement at approximately half of the baseline level. However, introduction of silicone into the interior of the syringe may require additional testing and regulatory approval processes.
Mold Textured ‘Line’ Syringe—According to this variable, longitudinal ‘line’ texturization features were molded onto an inner surface of the syringe, such as in the embodiments described in
‘Fine’ Roll Plunger Textured—Syringes rolled with the textured plunger saw a significant reduction in coefficient of friction (μ) and squeak effects. Minimal effect on the air rating (air entrapment) was observed.
Multiple Roll—The squeak exhibited an improvement with the multiple rolls during the first two phases but was significantly worse in Phase 3.
The purpose of this study was to isolate and analyze the variables that are considered potential contributing factors to squeak and air issues experienced during the rolling diaphragm syringe fill and delivery process. Variables or combinations of variables exhibiting the largest contribution of improvement will be implemented as applicable into the future Tool design. For each parameter, both PET material grade MN021 (93/280° F.) and MN052 (93/270° F.) syringes were evaluated for friction as well as fill and delivery performance. A standard baseline scenario was used to compare against each of the variations listed below.
Baseline: The baseline used for comparison includes a single roll with a standard smooth roll plunger with diameter of 1.835″ and a typical aging process of 60° C. for 16 hours which emulates changes due to shipping and storage conditions.
Silicone: A thin layer of silicone was applied to the inside of each syringe before rolling and aging per the standard baseline format.
Temperature Comparison: Syringes were rolled per the baseline format but were exposed to 40° C. for 24 instead of 60° C. for 16 hours.
Multiple Roll: Syringes were rolled multiple times, 2× and 5×, in comparison to the baseline single roll before aging per the baseline format.
Sterilization: Syringes were rolled per the baseline format and then sterilized with nominal and high E-Beam levels and aged per the baseline format.
Syringe Texture: Syringes with a fine ‘draw’ texture (i.e., smooth inner surface with no texturization features) and a ‘line’ texture that were imparted via the molding process and then rolled and aged per the baseline format.
Plunger Texture: A textured plunger seen in
I. Friction Test
Friction was evaluated for each variable listed above using a digital force gauge to calculate the peak tensile force as a result of sliding apart the two contacting surfaces. Two pieces of materials were laid on top of each other mimicking the contact they would have during fill. The top piece was attached to the force gauge while ensuring that the connection piece was maintained level and the bottom material attached to the base in order to remain in place. A weight of specified amount was placed on top of the layered materials in order to ensure contact. See
1.69(1)
1.13(1)
0.40(1)
Syringes of each variable listed above were tested per the Fill Performance. In each of the phases noted in this procedure, the effect of squeak considered both the duration of the squeaking as well as the intensity and developed as follows:
0.0
0.0
0.0
0.0
0.0
0.0
1.2
0.0
1.2
1.4
0.8
0.4
0.2
0.0
0.0
0.0
0.0
0.0
Syringes of each variable listed above were tested per the Fill Performance. In each of the phases noted in this procedure, air effects were evaluated considering the location of the air bubbles and the amount of combined surface area. An air rating was developed as follows:
2.4
2.4
1.6
2.0
2.2
2.0
2.6
2.6
2.4
2.2
2.2
1.8
Air ratings for syringes with silicone applied compared to the baseline. The air was consistently less with the silicone.
The multiple rolled syringes showed a slight improvement of the air rating across all phases and both material types; however, the MN052 syringes showed a similar or worse impact on the 5× roll syringes compared to the 2× roll across each phase.
The ‘Line’ textured syringe showed substantial improvement while the ‘draw’ textured syringe showed very minimal improvement in air presence.
The 40° C. syringes had an improved effect on presence of air in each phase and material type.
Silicone: Silicone showed a significant improvement across all three categories including squeak, friction and air results. The squeak was non-existent, the friction results were negligible and the air rating showed significant improvement at approximately half of the baseline level.
Sterilization: Sterilization showed no impact to the friction results. There was a minimal improvement on the air effects. The squeak showed no improvement between the baseline and nominal sterilization level in MN021 syringes and was slightly worse in the MN052 syringes. However, the High E-Beam level did show a slight improvement across both material types and each of the three phases.
Multiple Roll: The multiple rolled MN021 syringes showed a decrease in friction; however the MN052 syringes that have a lower baseline showed minimal change. There was not a significant improvement between to 2× and 5× rolled syringes. There was also an improvement in the air rating seen in the multiple rolled syringes versus the baseline although there was not a noticeable trend between the 2× and 5× syringes. The squeak showed an improvement with the multiple rolls during the first two phases but was significantly worse in Phase 3.
Textured Plunger: Syringes rolled with the textured plunger saw a significant reduction in coefficient of friction and squeak effects. There was no effect on the air rating.
Textured Syringes: The ‘line’ texture syringe nearly eliminated squeak with only one sample showing very minor squeak. These syringes also showed an improvement in air presence; however this was still not eliminated. The ‘draw’ texture syringes showed minimal improvement in both squeak and air.
40° C.: The syringes exposed to 40° C. rather than the 60° C. baseline resulted in no difference in friction. There was a significant reduction in squeak showing a very low rating in all phases and materials with exception of the MN021 syringes in Phase 1 which still saw an improvement. There was also an improvement in air presence. Although not as significant as with squeak, the air rating was consistently lower across each phase and material type.
It can be seen that certain variables had an impact, and although air effects were not eliminated by any sole parameter, squeak was eliminated with the use of both silicone and the ‘line’ textured syringes. Since silicone is not a preferred solution at this time, these ‘line’ textured syringes will serve to address the squeak issue moving forward.
It should be noted that the various aspects and embodiments of the present disclosure, while focused on the application to a rolling diaphragm syringe, may have application to any field that utilizes rolling diaphragm apparatuses for retaining and delivering a fluid.
While aspects of a rolling diaphragm syringe having a texturized inner surface and method of texturizing an inner surface of a rolling diaphragm syringe are 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.
The present application is a § U.S. national phase application under 35 U.S.C. § 371 of PCT International Application No. PCT/US2019/016621, filed 5 Feb. 2019 and claims priority to U.S. Provisional Application No. 62/626,400, filed 5 Feb. 2018, the disclosures of which are incorporated herein in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2019/016621 | 2/5/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62626400 | Feb 2018 | US |
