Patent Application
20150057608
The present invention generally relates to delivery devices and components thereof. More particularly, embodiments of the present invention relate to medical syringes and components thereof having improved ergonomics, versatility, and/or ease of use.
Delivery devices, such as syringes, are generally used as pumps to take in and/or expel materials. Delivery devices may be used for a wide variety of medical and non-medical purposes. Medical uses for delivery devices, such as syringes, may include, for example, administering a therapeutic injection to a patient or withdrawing blood from a patient. Non-medical uses for delivery devices may include, for example, applying an adhesive compound while constructing an article of manufacture or injecting a flavored liquid into a food product while cooking. While delivery devices, such as syringes, have been around in one form or another for centuries, there still remains a need for new delivery devices that are capable of offering improved ergonomics, versatility, and/or ease of use.
Many medical conditions and disorders require the administration of a medicament via a syringe. Such conditions and disorders include conditions or disorders of coagulation, or blood clotting. Coagulation is a complex process by which blood forms clots. It is an important part of hemostasis, the cessation of blood loss from a damaged vessel, wherein a damaged blood vessel wall is covered by a platelet and fibrin-containing clot to stop bleeding and begin repair of the damaged vessel. Conditions and disorders of coagulation can lead to an increased risk of bleeding (hemorrhage) or obstructive clotting (thrombosis).
Hemophilia is one of the most common inherited coagulation disorders in the world. It results in decreased in vivo and in vitro blood clotting activity, and requires extensive medical monitoring throughout the life of the affected individual. In the absence of intervention, the individual affected by will suffer from spontaneous bleeding in the joints, muscles, throat, neck, kidneys, and other parts of the body, often leading to other serious medical complications. Severe bleeding may also result from routine surgery, dental extractions, and even minor injuries. Even microbleeds—pinpoint drops of blood that leak from blood vessels—may cause severe damage to the body over time.
In hemophilia, coagulation is disturbed by a lack of certain plasma blood clotting factors. For example, hemophilia A is caused by a deficiency in Factor VIII (FVIII), while hemophilia B is caused by a deficiency in Factor IX (FIX). Each of these forms of hemophilia may result from either the decreased synthesis of the relevant blood clotting factor protein (e.g. FVIII or FIX) or a defective blood clotting factor protein with reduced activity.
The treatment of hemophilia occurs by replacing the missing blood clotting factor protein by exogenous factor concentrates highly enriched in the missing clotting factor. However, generating such a concentrate from blood is fraught with technical difficulties. In addition, replacement clotting factors typically have short half-lives and therefore require frequent dosing for affected individuals.
The necessary blood clotting factor proteins are typically administered at least several times a week via intravenous injections to the individual affected by hemophilia using a syringe. While some affected individuals may receive injections from a caregiver, many individuals chose to self-administer injections, often for reasons of cost and convenience.
Because individuals affected by hemophilia are highly susceptible to accidental bleeding in everyday situations, stress points on tools (e.g. syringes), stress points generated by environmental surfaces (e.g. the surface or edge of a table), and stresses resulting from unnatural movements of the body have the potential to cause microbleeds as the individual interacts with tools in their environment. In the case of routine injections using a syringe, particularly for affected individuals who self-administer treatments, even small positive changes in syringe configurations and the movements necessary to administer and receive an injection have the potential to minimize microbleeds or other injuries to the individual.
Reduced mortality, prevention of joint damage, and improved quality of life have been important achievements resulting from the development of suitable replacement blood clotting factors, such as FVIII and FIX. However, currently available syringes for administering these treatments have many structural and functional shortcomings that make them suboptimal—and in some cases even potentially harmful—to individuals affected by hemophilia.
Therefore, there remains a need for new delivery devices, such as syringes, offering improved ergonomics, versatility, and/or ease of use, particularly for use by patients or caregivers administering hemophilia treatments.
It should be noted, however, that while the present discussion focuses primarily on the use of syringes for medical purposes generally, and for the treatment of hemophilia specifically, the embodiments of delivery devices described herein need not be limited to syringes, need not be so limited in application, and may be suitable for a variety of non-medical purposes, or for treating medical conditions beyond hemophilia.
Embodiments of the present invention relate to a delivery device, such as a syringe. The delivery device may include a barrel holding a liquid for delivery. The delivery device may also include a finger flange assembly coupled to the barrel. The finger flange assembly may include a first flange and a second flange each extending laterally from opposite sides of the finger flange assembly, wherein the first flange and the second flange each curve toward the barrel. The delivery device may also include a plunger coupled to the barrel and passing through the finger flange assembly. The plunger may include a disc-shaped head.
Embodiments of the present invention also relate to a finger flange assembly configured for use with a delivery device, such as a syringe. The finger flange assembly may include a substantially cylindrical trunk having a proximal end and a distal end, wherein the distal end of the trunk is configured to attach to the barrel of the delivery device. The finger flange assembly may also include a first flange and a second flange each extending laterally from opposite sides of the proximal end of the trunk, wherein the first flange and the second flange each curve toward the distal direction and terminate in respective first and second flange tips, wherein the first flange and the second flange each become narrower as they extend toward the respective first and second flange tips.
Embodiments of the present invention further relate to a plunger configured for use with a delivery device, such as a syringe. The plunger may include a circular disc-shaped head at a proximal end of the plunger. The plunger may also include a rod coupled to and extending distally from the head, wherein the proximal surface of the head includes a spherical dimple.
In another aspect, embodiments of the present invention are directed to a kit comprising the delivery device described herein and a package insert. The package insert can include an instruction for using the delivery device, for administering a medicament, or for treating the disorder or condition.
Embodiments of the delivery devices described herein can include a medicament, which may be any therapeutic that can be administered in a liquid formulation. In some embodiments, medicaments may include small molecule biologics, large molecule biologics, and proteins. In one embodiment, the medicament may be a protein capable of treating a blood clotting disorder, such as a clotting factor. The protein may be lyophilized.
In one embodiment, the protein is a FVIII protein. In another embodiment, the protein is a FIX protein. The FVIII protein can be any FVIII known in the art such as, for example, a functional fragment, a variant, an analog, or a derivative thereof that retains the function of full-length wild-type FVIII in the coagulation pathway. The FVIII protein can be the human, porcine, canine, rat, or murine FVIII protein. In other embodiments, the FVIII or FIX protein is a chimeric protein. The chimeric protein can comprise a FVIII or FIX subsequence and a second substance. In one embodiment, the second subsequence is capable of extending the half-life of the FVIII protein. In another embodiment, the second substance comprises an Fc or an albumin. In other embodiment, the FVIII or FIX protein can further comprise an additional subsequence, such as an additional Fc.
Further embodiments, features, and advantages of the present invention, as well as the structure and operation of the various embodiments of the present invention, are described in detail below with reference to the accompanying drawings.
The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present invention by way of example, and not by way of limitation, and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention.
The present invention will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings. References to “one embodiment”, “an embodiment”, “an example embodiment”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
As illustrated in the front view of
The proximal end 104 of the syringe 100 depicted in
As further illustrated by
Turning first to the barrel 400 component of the syringe 100,
The main body 406 of the barrel 400 of the syringe 100 may be primarily responsible for holding one or more materials (e.g. liquids, gases, and/or solids) inside the barrel 400. In one embodiment, the main body 406 may include multiple chambers for holding one or more materials in isolation from one another. The main body 406 may be one of many shapes or sizes, depending on the particular application. For example, the main body 406 may take the shape of a cylinder, a rectangular prism, a sphere, a cube, a cone, a pyramid, or combinations thereof. The main body 406 illustrated in
The main body 406 may be made from a variety of materials. In one embodiment, such as that depicted in
In addition to the main body 406, the barrel 400 of the syringe 100 may also include one or more pistons (e.g. 410 or 414). The piston may be contained within and capable of moving relative to the main body 406. The motion of the piston within the main body 406 in a distal direction may cause materials held by the main body 406 to be expelled by the syringe 100. Conversely, the motion of a piston within the main body 406 in a proximal direction may cause materials held outside of the syringe 100 to be drawn into the main body 406. Pistons may operate by creating pressure differentials or vacuums that cause material to flow from an area of relatively high pressure to an area of relatively low pressure.
In one embodiment of the present invention, the main body 406 of the barrel 400 may include a single piston. In other embodiments, the main body 406 may include multiple pistons.
Pistons may be one of many shapes or sizes, depending on the particular application. The size and shape of a piston may depend on the corresponding size and shape of the main body 406 that the piston is contained within. For example, as shown in
Pistons, such as the proximal piston 410 and the distal piston 414, may be made from a variety of materials. In one embodiment, pistons may be made from one or more plastics, such as those described above. In another embodiment, such as that depicted in
In addition to the main body 406 and one or more pistons, the barrel 400 may further include a hub 420, as illustrated in
The hub 420 may consist of several subcomponents. In one embodiment, as illustrated in
The above-described components of the main body 406 of the barrel 400 of the syringe 100 may work together to retrieve, hold, and/or dispense materials to and from the syringe 100. For example, the main body 406 of the barrel 400 may hold a medicament, such as a pharmaceutical composition, for later dispensation out of the hub 420 of the syringe 100. As previously indicated, one or more pistons of the barrel 400 may enable movement of a medicament or other material through the syringe 100.
The barrel 400 of the syringe 100 illustrated in
Certain medicaments, such as pharmaceutical compositions, may retain a longer shelf life when stored in certain states. For example, certain therapeutic proteins may be stored and kept for relatively long periods of time in a solid lyophilized (i.e. freeze-dried) state. However, prior to therapeutic use, such medicaments may need to be reconstituted and reactivated by mixing them with a diluent liquid.
The embodiments described herein are capable of being used with a wide variety of medicaments, including pharmaceutical compositions stored in a lyophilized state. The embodiments described herein are capable of being used with a wide variety of diluents, as necessary. In one embodiment, the syringe 100 barrel 400 may store a therapeutic in a liquid formulation for treating any disease or disorder that may be treated via an injection such as, for example, an intradermal, subcutaneous, intramuscular, or intravenous injection. In another embodiment, the syringe 100 barrel 400 may store one or more lyophilized proteins used in the treatment of bleeding disorders or conditions. Examples of the bleeding conditions or disorders include, but are not limited to, a bleeding coagulation disorder, hemarthrosis, muscle bleeding, oral bleeding, hemorrhage, hemorrhage into muscles, oral hemorrhage, trauma, trauma capitis, gastrointestinal bleeding, intracranial hemorrhage, intra-abdominal hemorrhage, intrathoracic hemorrhage, bone fracture, central nervous system bleeding, bleeding in the retropharyngeal space, bleeding in the retroperitoneal space, or bleeding in the illiopsoas sheath. In some aspects, the proteins in the syringe 100 can be used prophylactically or on-demand. In other aspects, the proteins in the syringe 100 can be used before, during, or after surgery.
In one embodiment, the medicament may be any therapeutic that can be administered in a liquid formulation. In some embodiments, medicaments may include small molecule biologics, large molecule biologics, and proteins. In one embodiment, the medicament may be a protein capable of treating a blood clotting disorder, such as a clotting factor. The protein may be lyophilized. The medicament may be stored in the syringe 100.
In one embodiment, one or more proteins that can be stored in the syringe 100 and may include, but are not limited to, FVIII coagulation factor proteins or FIX coagulation factor proteins. Additional clotting factor proteins that may be stored in the present syringe 100 include, for example, factor I (fibrinogen), factor II (prothrombin), Tissue factor, factor V (proaccelerin, labile factor), factor VII (stable factor, proconvertin), factor X (Stuart-Prower factor), factor XI (plasma thromboplastin antecedent), factor XII (Hageman factor), factor XIII (fibrin-stabilizing factor), VWF, prekallikrein (Fletcher factor), high-molecular-weight kininogen (HMWK) (Fitzgerald factor), fibronectin, antithrombin III, heparin cofactor II, protein C, protein S, protein Z, plasminogen, alpha 2-antiplasmin, tissue plasminogen activator (tPA), urokinase, plasminogen activator inhibitor-1 (PAI1), and plasminogen activator inhibitor-2 (PAI2). The barrel 400 may also store a liquid diluent 416 for reconstituting the lyophilized proteins such as, for example, sterile water for injection, a sodium chloride solution, saline, or a WFI solution.
Returning to
It should be noted that in other embodiments, other suitable dual-chamber syringe structures may be used wherein a liquid diluent and a medicament are held apart from one another by other means other than separation by a plunger within the barrel, including two parallel barrels.
As illustrated in
Were the main body 406 of the barrel 400 of the syringe 100 to maintain a uniform circular cross sectional area along its cylindrical length, the liquid diluent 416 and solid medicament 418 may be held in isolation indefinitely and may not be capable of mixing. However, in one embodiment, as illustrated in
In
In one embodiment of the present invention, the main body 406 of the barrel 400 of the syringe 100 may be optimized and proportioned to allow for drawback during an injection. Draw-back is the act of pulling upward on the plunger 300 of a syringe 100 in the context of otherwise administering an injection. Drawback in useful in intravenous injections, such as, for example, injections to hemophilia patients, so that the user of the syringe 100 may confirm that the injection is in fact properly entering into a vein. Proper injection is confirmed when blood from the vein is drawn back into the syringe 100 temporarily. Were the injection not properly entering the vein, the drawback of blood would not be effective.
In the case of a dual chamber syringe 100 with a proximal piston 410, a distal piston 414, and a bypass 408, such as in the embodiment described above, draw-back may be desirable in the course of an injection. However, if the main body 406 of the barrel 400 of the syringe 100 is not optimally configured and proportioned, draw-back may be impeded by the fluid dynamics of the syringe 100. Specifically, once the distal piston 414 has moved distally past the bypass 408 in the injection cycle, the fluid dynamics of the main body 406 may be such that it is not possible to create a sufficient vacuum by moving the plunger 300 to draw the distal piston 414 back proximally beyond the bypass 408 where it started. If there is not enough space for the distal piston 414 to move proximally backward to allow for sufficient draw-back volume, this hindered ability to draw-back may be undesirable to certain users, such as those administering injections to a hemophilia patient.
In one embodiment of the present invention, the volume and/or length of the main body 406 of the barrel 400 of the syringe 100 is proportioned to be sufficiently voluminous and/or long such that sufficient draw-back is possible. More specifically, in an embodiment, the volume and/or length of the main body 406 of the barrel 400 of the syringe 100 distal to the bypass 408 is sufficiently large and/or lengthened such that sufficient draw-back is possible. For example, in various embodiments, the main body 406 may have a total volume of approximately 5 ml total and approximately 2.5 ml distal to the bypass 408, a total volume of approximately 2.5 ml total and approximately 1.25 ml distal to the bypass 408, or a total volume of approximately 1 ml total and approximately 0.5 ml distal to the bypass 408. In other embodiments, other total volumes and volumes distal to the bypass 408 may be appropriate, depending on the size of the main body used. In another embodiment, the main body 406 may have a length of between 80 mm and 120 mm total or between 42 mm and 64 mm distal to the bypass 408, between 82.5 mm and 87.5 mm total or between 44 mm and 46 mm distal to the bypass 408, or approximately 85 mm total or about 45 mm distal to the bypass 408.
Compared to conventional syringes 100, which may have main bodies 406 with total volumes and/or lengths or volumes and/or lengths distal to a bypass 408 that are different than those specified above, embodiments of the present invention with proportions as specified above may allow a user of the syringe 100 to readily confirm that an injection is in fact properly entering into a vein without struggling to draw back. In this way, a syringe 100 with a bypass 408 proportioned as specified above may provide a hemophilia patient self-administering an injection with an ergonomic structure that is easy to use and that does not require repeated realignments or manipulation struggles, which can lead to the generation of microbleeds.
Regardless of the volume or length of the main body 406, the number of pistons employed, or whether or not a medicament 418 needs to be reconstituted prior to evacuation from the syringe 100, materials may leave and enter the syringe through the hub 420 of the barrel 400 of the syringe 100.
In one embodiment, as illustrated in
As shown in
As shown in
The infusion set connector 506 may including a complementary fastener mechanism for mating with the fastener mechanism of the hub connector 422 of the barrel 400 of the syringe 100, such as, for example, a plastic Luer lock, Luer cone, Luer slip, or other suitable threaded, friction fit, or other fastening means.
The flexible tube 508 may be made from, for example, silicone or polyvinyl chloride tubing. In various embodiments, the flexible tube 508 may be between 5 mm and 50 mm long.
The set of stabilizing wings 510, located just before the distal end 504 of the infusion set 500, may be made of one or more of the above-mentioned plastics in one embodiment. The structure of the wings 510 may make it easier for a patient or caregiver to grasp and insert the needle 512 at a relatively shallow angle into a relatively small vein, such as a vein in the hand, wrist, or other locations where the vein is close to the surface of the skin. The wings 510 may also aid in keeping the needle 512 in place and to prevent damage to the patient's vessels if the patient moves during the syringe 100 procedure.
The needle 512 itself is used to pierce the patient's skin and to deliver materials to or withdraw materials from the patient's body. Suitable needles may include standard needles used for intradermal, subcutaneous, intramuscular, or intravenous injections, depending on the particular application. Finally, the needle 512 may be temporarily enclosed by a needle tip cover 514 for protecting the needle 512 and for preventing accidental needle sticks.
Because individuals affected by hemophilia are highly susceptible to accidental bleeding in everyday situations, stress points on tools, such as the infusion set 500, and stresses resulting from unnatural movements of the body required to insert the needle 512 into a vein or to receive the needle in one's vein have the potential to cause microbleeds. The use of an the infusion set 500 with a set of stabilizing wings 510 may help to make the insertion of the needle 512 a more ergonomics process, and to minimize movement of the needle 512 after insertion.
Turning now to the finger flange assembly 200 component of the syringe 100,
The finger flange assembly 200 may be made from a variety of materials. In one embodiment, the finger flange assembly 200 may be made from one or more plastics such as, for example, polyvinylchloride, polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane, polyetherimide, polycarbonate, polyetheretherketone, polysulfone, polypropulene, cyclic olefin polymer, cyclic olefin copolymer, or combinations thereof. The finger flange assembly 200, or portions thereof, may be opaque. In other embodiments, the main body 406, or portions thereof, may be transparent or translucent. In one embodiment, the finger flange assembly 200 may be made by an injection molding manufacturing process.
In some embodiments, the finger flange assembly 200 may be a unitary structure manufactured as a unitary piece of material. In other embodiments, the finger flange assembly 200 may consist of two or more discrete pieces of material that are joined together to form the finger flange assembly 200 of the syringe 100. In one embodiment of the present invention, the finger flange assembly 200 may be integrally formed with the barrel 400 of the syringe 100 such that the finger flange assembly 200 and the barrel 400 are a unitary structure. Regardless of whether the finger flange assembly 200 is made of discrete components or whether it is integrally formed with the barrel 400, the finger flange assembly 200 or portions thereof may be releasably or permanently affixed to other components of the syringe 100 by fastener means such as, for example, an adhesive, threaded means, a friction fit, or other suitable means.
In the exemplary embodiment shown in
The trunk 206 of the finger flange assembly 200 may be centered about the central axis 102 of the syringe 100 and may be the portion of the finger flange assembly 200 that couples to the barrel 400 of the syringe. Such coupling can be seen, for example, in
In some embodiments of the present invention, one or more flanges may branch out from the trunk 206 of the finger flange assembly 200. In the embodiment depicted in
Compared to conventional syringes, which may have asymmetrical finger flange assemblies, embodiments of the present invention with symmetrical finger flange assemblies 200 may allow users to quickly manipulate the syringe 100 without first having to realign the finger flange assembly 200 to an optimal alignment, or orient the syringe 100 in their hand so that their fingers “match” the configuration of the finger flange assembly 200. In this way, a symmetrical finger flange assembly 200 may provide a hemophilia patient self-administering an injection with an ergonomic structure that is easy to use and that does not require repeated realignments, which can lead to the generation of microbleeds.
The finger flange assembly 200 may be considered to have a proximal end 202 and a distal end 204. As indicated in
In an embodiment, as shown in
Compared to conventional syringe finger flange assemblies, which generally have finger flange assemblies that stick straight out with little or no curvature, embodiments of the present invention having a first flange 208 and a second flange 214 that gradually curve and taper outward from the trunk 206 may provide a hemophilia patient self-administering an injection with an ergonomic structure that is easy to use and grip during an injection. If a finger flange assembly includes no curvature, a user's fingers may tend to slip off of the finger flange assembly during the administration of an injection. However, if a finger flange assembly includes too severe of a curvature, a user's fingers may tend to undesirably get caught in the finger flange assembly during the administration of an injection, even at times when it may be desirable for the user to temporarily remove their fingers.
Repeated unnecessary realignments and re-grips or undesirable ensnaring of a user's fingers can lead to overall poor ergonomics and the generation of microbleeds. As described above, this repeated microbleed generation over time has the potential to cause severe damage to the body of a person affected by hemophilia. Given the need for regularly scheduled blood clotting factor protein injections for many hemophilia patients, an optimally designed finger flange assembly offering improved ergonomics, versatility, and/or ease of use is of great value.
The curvatures of the first flange curve 210 region and the second flange curve 216 region may vary according to the application. In one embodiment, the curvature of the first flange curve 210 region and the curvature of the second flange curve 216 region may be equal. In another embodiment, the curvature of the first flange curve 210 region and the curvature of the second flange curve 216 region may not be equal.
As indicated above, a symmetrical finger flange assembly 200 where the curvature of the first flange curve 210 region and the curvature of the second flange curve 216 region are equal may provide a hemophilia patient self-administering an injection with an ergonomic structure that is easy to use and that does not require repeated realignments, which can lead to the generation of microbleeds.
In one embodiment, the trunk 206 of the finger flange assembly 200 may define a central axis running down the center of the trunk 206 in the proximal-distal direction. This axis may be coextensive with the central axis 102 of the syringe 100 depicted in
In another embodiment, as illustrated in
If the flange tip height 224 is too short, in some embodiments of the present invention, a user's fingers may tend to slip off of the finger flange assembly during the administration of an injection. However, if the flange tip height 224 is too long, a user's fingers may tend to undesirably get caught in the finger flange assembly during the administration of an injection, even at times when it may be desirable for the user to temporarily remove their fingers. As explained above, repeated unnecessary realignments and re-grips or undesirable ensnaring of a user's fingers can lead to overall poor ergonomics and the generation of microbleeds in hemophilia patients.
As further illustrated in
As further illustrated by
If the degree of taper is too great, in some embodiments of the present invention, a user's fingers may tend to slip off of the finger flange assembly during the administration of an injection. However, if the degree of taper is too subtle, a user's fingers may tend to undesirably get caught in the finger flange assembly during the administration of an injection, even at times when it may be desirable for the user to temporarily remove their fingers. As explained above, repeated unnecessary realignments and re-grips or undesirable ensnaring of a user's fingers can lead to overall poor ergonomics and the generation of microbleeds in hemophilia patients.
In addition, if the first flange tip 212 and second flange tip 218 terminate in lateral-most ends that present overly sharp edges, these edges may act as stress points that have the potential to cause microbleeds in an individual affected with hemophilia as the individual interacts with the syringe 100. However, a relatively narrow first flange tip 212 and second flange tip 218 may allow the user to remove their fingers from the finger flange assembly 200 more easily as desired.
In one embodiment, as shown in
If the assembly width 220 is too short, in some embodiments of the present invention, a user's may not be able to comfortably fit all of the desired finger or fingers into the finger flange assembly during the administration of an injection. However, if the assembly width 220 is too long, use of the finger flange assembly may become cumbersome and the flange tips may act as stress points.
With reference to the distances illustrated in both
In some embodiments, these ratios may allow a user to comfortably and effectively grasp the finger flange 200 of the syringe 100 in their hand without repeated unnecessary realignments and re-grips or undesirable ensnaring of a user's fingers, thus avoiding poor ergonomics and the generation of microbleeds in hemophilia patients.
In some embodiments, while the flange tip height 224 and assembly width 220 may be substantially shorter or substantially longer than those described above to suit the needs of individuals having smaller than average hands (e.g. small children) or larger than average hands, respectively, the overall ratio of between 1:2 and 1:8, between 1:4 and 1:6, or approximately 1:5 may be maintained. In other words, the overall configurations of some embodiments of the present invention may be proportionally scalable when compared to some of the embodiments described above as determined by user needs.
Turning now to the plunger 300 component of the syringe 100,
The plunger 300 may be made from a variety of materials. In one embodiment, the plunger 300 may be made from one or more plastics such as, for example, polyvinylchloride, polytetrafluoroethylene, polyethersulfone, polyethylene, polyurethane, polyetherimide, polycarbonate, polyetheretherketone, polysulfone, polypropulene, cyclic olefin polymer, cyclic olefin copolymer, or combinations thereof. The plunger 300, or portions thereof, may be opaque. In other embodiments, the plunger 300, or portions thereof, may be transparent or translucent. In one embodiment, the plunger 300 may be an injection molding manufacturing process.
In some embodiments, the plunger 300 may be a unitary structure manufactured as a unitary piece of material. In other embodiments, the plunger 300 may consist of two or more discrete pieces of material that are joined together to form the plunger 300 of the syringe 100.
In the exemplary embodiment shown in
In embodiments where the head 312 of the plunger 300 is circular, the symmetry of the circular head may prevent a user from having to realign the head for optimal depression and withdrawal of the head during injection and drawback. In addition, if the head diameter 314 is too small, in some embodiments of the present invention, a user's finger or thumb may tend to slip off of the finger flange assembly during the administration of an injection. Repeated unnecessary realignments and re-grips of a plunger 300 can lead to overall poor ergonomics and the generation of microbleeds in hemophilia patients.
The top view of the plunger 300 in
Dimples 318 may take on a variety of shapes and sizes. For example, dimples 318 may have circular, triangular, square, oval, spherical, cylindrical, conical, cubical, or other dimensions. Dimples 318 may also be placed on a variety of locations around the surface of the head 312. In the embodiment of
As further illustrated by
In one embodiment of the present invention, the ratio of the head diameter 314 to the dimple diameter 322 may be between 2:1 and 3:1 or between 1.0:1 and 1.5:1.
Depending on the size of the head 312 and the particular application, if the dimple diameter 322 is too small, in some embodiments of the present invention, the benefits of the dimple such as, for example, increased friction, texture, structural differentiation may be lost. Likewise, if the dimple diameter 322 is too large, these same benefits may also be lost. As explained above, repeated unnecessary realignments and re-grips of a plunger 300 can lead to overall poor ergonomics and the generation of microbleeds in hemophilia patients.
In some embodiments, while the head diameter 314 and dimple diameter 322 may be substantially shorter or substantially longer than those described above to suit the needs of individuals having smaller than average hands (e.g. small children) or larger than average hands, respectively, the overall ratio of between 2:1 and 3:1 or between 1.0:1 and 1.5:1 may be maintained. In other words, the overall configurations of some embodiments of the present invention may be proportionally scalable when compared to some of the embodiments described above as determined by user needs.
In some embodiments, the relative smoothness of the incurvate edge 326 as opposed to a more conventional linear edge may provide some level of protection against the generation of microbleeds in hemophilia patients, as well as increased friction, texture, structural differentiation on the bottom side of the head 312 of the syringe.
Additional features of the plunger 300 according to embodiments of the present invention are illustrated by the side, front and sectional views of an exemplary plunger 300 in
In one embodiment, the plunger 300 may include a plunger connector 330 at its distal end 304 for engaging a proximal piston connector 412 of the proximal piston 410 (such as the proximal piston 410 illustrated in
The rod 306 of the plunger 300 running from the head 312 to the plunger connector 330 may be a cylinder having a substantially uniform diameter throughout most of its length, as illustrated in
As illustrated in
In some embodiments, while the head diameter 314 and rod diameter 308 may be substantially shorter or substantially longer than those described above to suit the needs of individuals having smaller than average hands (e.g. small children) or larger than average hands, respectively, the overall ratio of greater than 2.5:1 may be maintained. In other words, the overall configurations of some embodiments of the present invention may be proportionally scalable when compared to some of the embodiments described above as determined by user needs.
As further illustrated in
Depending on the size of the head 312 and the particular application, if the dimple 318 is too small, in some embodiments of the present invention, the benefits of the dimple such as, for example, increased friction, texture, structural differentiation may be lost. Likewise, if the dimple 318 is too large, these same benefits may also be lost. As explained above, repeated unnecessary realignments and re-grips of a plunger 300 can lead to overall poor ergonomics.
In some embodiments, the dimple measurements may be substantially shorter or substantially longer to suit the needs of individuals having smaller than average hands (e.g. small children) or larger than average hands, respectively, and may be proportionally scalable when compared to some of the embodiments described above as determined by user needs.
In some embodiments, the spherical nature of the dimple 318 may add to the structural differentiation of this component, and may be capable of creating a suction or vacuum affect against the surface of a user's thumb, finger or the palm of their hand when depressed on the surface of the dimple, thus increasing the grip on the head 312 of the plunger 300.
As also shown in
In some embodiments, the relative smoothness of the incurvate edge 326 as opposed to a more conventional linear edge may provide some level of protection against the generation of microbleeds in hemophilia patients, as well as increased friction, texture, structural differentiation on the bottom side of the head 312 of the syringe, particularly within certain tolerances.
In some embodiments, the incurvate edge measurements may be substantially shorter or substantially longer to suit the needs of individuals having smaller than average hands (e.g. small children) or larger than average hands, respectively, and may be proportionally scalable when compared to some of the embodiments described above as determined by user needs.
Turning now to
In the illustrated embodiment, the other finger flange (in this case the first flange 208) may be secured in the palm 602 of the user's hand 600. In alternate embodiments, if the user so desires and if the syringe 100 so fits their hand 600, the first flange 208 may curve and wrap over the back side of the user's hand 600. In the embodiment of
Because of the configuration of the depicted embodiment of the syringe 100, the user can comfortably, ergonomically grasp the syringe 100 and may easily adjust their grip as necessary during an injection. In a typical intravenous injection for a hemophilia patient, the user is primarily depressing the plunger 300 to inject the medicament 418, but may also need to frequently draw back on the plunger 300 to look for blood in the flexible tube 508 of the infusion set 500 to ensure that the injection is in fact proceeding into a vein. Because of this, the user may need to occasionally move their fingers or thumb to switch between injection and draw-back positions, or may need to switch their style of grip entirely.
Compared to conventional syringe finger flange assemblies, which have more traditional finger flange and plunger configurations, embodiments of the present invention described above with respect to one or more of
For example, with respect to the joystick grip depicted in
In addition, the head 312 of the plunger 300 including the dimple 318 are configured so that a user's thumb in the joystick grip may be able to easily locate and securely grip the head 312 of the plunger 300, and easily actuate the head 312 in both injection and draw-back phases. Again, in such an embodiment, the configuration of the head 312 of the plunger 300 is such that it minimizes potential stress points while maximizing ergonomics and flexibility.
Repeated unnecessary realignments and re-grips or undesirable ensnaring of a user's fingers or thumb can lead to overall poor ergonomics and the generation of microbleeds. As described above, this repeated microbleed generation over time has the potential to cause severe damage to the body of a person affected by hemophilia. Given the need for regularly scheduled blood clotting factor protein injections for many hemophilia patients, an optimally designed syringe offering improved ergonomics, versatility, and/or ease of use is of great value.
As explained in further detail above, drawback in useful in intravenous injections, such as, for example, injections to hemophilia patients, so that the user of the syringe 100 may confirm that the injection is in fact properly entering into a vein. Proper injection is confirmed when blood from the vein is drawn back into the syringe 100 temporarily. Compared to conventional syringes 100, which may have heads 312 of plungers 300 that are proportioned differently than those specified above, embodiments of the present invention with sufficiently large circular plunger 300 heads 312 may allow a user of the syringe 100 to more easily execute a draw back movement with their thumb in a way that does not require repeated realignments or manipulation struggles, which could lead to the generation of microbleeds.
In alternate embodiments, if the user so desires and if the syringe 100 so fits their hand 600, the user may insert other fingers besides the middle 608 and index 606 fingers into the first flange 208 and the second flange 214. In the embodiment of
The configuration of this exemplary syringe 100 offers some of the same benefits to a user employing that two-finger grip that it does to a user employing the joystick grip. For example, with respect to the two-finger grip depicted in
In alternate embodiments, if the user so desires and if the syringe 100 so fits their hand 600, the user may insert other fingers besides the ring 610 and middle 608 fingers into the first flange 208 and the second flange 214. In the embodiment of
Compared to conventional syringe plunger heads, which typically have smaller plunger head surface areas and no dimples, embodiments of the present invention described above with respect to one or more of
In one embodiment of the present invention, parts of the syringe 100 may include portions with increased texture or a different material to aid in the ability of a user to grip the syringe 100. For example, the first flange 208 and the second flange 214 may include first and second rubber portions, respectively, on their proximal and/or distal surfaces. In another embodiment, the head 312 of the plunger 300 may include a rubber portion on its proximal and/or distal surface. In other embodiments, increased texture maybe provided by using materials other than rubber or by scoring, stippling, dimples, ridges, or other textural surface elements.
In a further embodiment of the present invention, different syringes 100 may be designed for different doses of medicament 418. For example, syringes 100 may be pre-filled with medicaments 418 having different concentrations, volumes, and/or strengths. In an embodiment, a portion of each syringe 100 may be colored with a specific color, wherein the syringe 100 is color coded to indicate the dose of the medicament 418 that it contains. For example, the texturized or rubberized portions of the syringe 100 described above may be color coded.
In another embodiment of the present invention, parts of the syringe 100 may include portions having product labeling. Labeling may be included by the addition of label stickers or by having the labeling printed, caved, molded, or otherwise formed on or in parts of the syringe 100. In some embodiments the syringe 100 is labeled to indicate the dose of the medicament 418 that it contains.
In another aspect, the invention is directed to a kit comprising the syringe 100 described herein and a package insert. The package insert may include an instruction for using the syringe 100, for administering the medicament 418, or for treating a disorder or condition. The kit may comprise a medicament 418, which may be contained in the syringe 100 or may be contained separately from the syringe 100. The medicament 418 may be in unit dosage form in one of the doses described herein.
It should be noted, that while the above discussion focuses primarily on the use of syringes for medical purposes generally, and for the treatment of hemophilia specifically, the embodiments of delivery devices described herein need not be limited to syringes, need not be so limited in application, and may be suitable for a variety of non-medical purposes, or for treating medical conditions beyond hemophilia.
The present invention has been described above by way of exemplary embodiments. Accordingly, the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalences.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US13/34396 | 3/28/2013 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61617340 | Mar 2012 | US |
