Continuous administration device and method

Abstract

The drug administration system includes a syringe body having a proximal and distal end, an interior of the syringe, and a syringe flange provided at the proximal end, and a drug placed inside the syringe. The system also includes a finger flange coupled to the syringe flange and defining the interior and side windows of the finger flange. The system further includes a stopper member located inside the syringe. Furthermore, the system includes a plunger member coupled to the stopper member and at least partially located inside the finger flange. Furthermore, the system includes a thumb pad coupled to the proximal end of the finger flange and operably coupled to the plunger member. The system also includes a cam configured to rotate by a preset angular distance each time the thumb pad is fully pressed into the finger flange, and a ratchet configured to advance the plunger member by a preset longitudinal distance.

Description

Technical Field

[0001] The present disclosure generally relates to drug delivery systems, devices, and processes for facilitating various levels of control over the dispensing, infusion, and / or injection of fluids or gels, and more particularly to systems and methods related to a delivery system for continuously administering multiple doses of a drug.

Background Art

[0002] Millions of syringes, as shown in Figure 1A(2), are consumed daily in the healthcare setting. A typical syringe (2) includes a tubular body (4), a plunger (6), and an injection needle (8). As shown in Figure 1B, such syringes (2) can be used not only to inject fluids into patients but also to draw fluids from or into containers such as vials, bags, or other drug storage systems (10). In fact, in some countries, such as the United States, due to concerns about maintaining sterility and regulatory constraints, if a vial (10) is used with a syringe (2), as shown in certain patient settings, such a vial must be used for only one patient and then disposed of, resulting in a large amount of medical waste from the discarded vials and remaining medication, and also causing periodic shortages of certain essential medications. Referring to Figure 2A, three Luer syringes (12) are shown, each having a Luer connector shape (14) located distally, which are connected to other devices having similar connector shapes, such as the Luer manifold assembly (16) shown in Figure 2B. The Luer manifold assembly in Figure 2B can be used to intravenously administer liquid medication to a patient, with or without the use of an intravenous infusion bag. The Luer connector (14) of the syringe in Figure 2A is sometimes called a “male” Luer connector, and the Luer connector (18) in Figure 2B is sometimes called a “female” Luer connector, and one of the Luer interfaces has a threaded surface (in this case, the configuration is sometimes called a “Luer lock” configuration) so that the two are connected by relative rotation, which may also be combined with a compressive load. In other words, in one embodiment of a Luer lock, rotation, sometimes along with compression, is used to engage the threads of a male fitting (14), which then engage with a flange on a female fitting (18) to form a fluid-sealed coupling of the devices. In another embodiment, a tapered interface shape may be used to provide a Luer engagement using compression without the use of threads or rotation (such configurations may be referred to as “slip-on” or “conical” Luer configurations).While such Luer connectors are considered relatively safe for operators, there is a risk of drug spillage, leakage, or component damage during assembly. On the other hand, using needle injection configurations carries the risk of sharp needles coming into contact with or puncturing people or undesirable structures. For these reasons, so-called "safety syringes" have been developed.

[0003] One embodiment of the safety syringe (20) is shown in Figure 3, in which a tubular shield member (22) is spring-biased to cover the needle (8) when released from the proximal / retracted position relative to the syringe body (4). The tubular needle shield (22) is "locked" in a distal / extended configuration. As a result, the needle shield (22) cannot return to the proximal / retracted position, thereby preventing needle stick injuries after injection.

[0004] Another embodiment of the safety syringe (24) is shown in Figures 4A and 4B. In this configuration, after the plunger (6) is fully inserted into the syringe body (4), the retractable needle (26) is retracted to a safe position within the tubular body (4) (28, 26), as shown in Figure 4B. Such a configuration, which is housed in itself, may be associated with problems of blood splatter / aerosolization, safe storage of preloaded energy that could malfunction and cause premature operation, loss of precision when delivering the full dose due to residual dead space in the spring compression volume, and / or loss of control over the retraction rate, which may be associated with pain or patient anxiety.

[0005] The increasing demand for pre-filled syringe assemblies, as shown in Figures 5A and 5B, is further complicating the syringe market, which generally comprises a syringe body or “drug containment delivery system” (34), a plunger tip, plug or stopper (36), and a distal seal or cap (35) attached to a Luer interface (Figure 5A shows the cap (35) in position, while Figure 5B shows the cap removed to illustrate the Luer interface 14). The liquid drug resides in the volume between the distal seal and the distal end (37) of the plunger tip or stopper (36), or in a drug reservoir (40). The plunger tip or stopper (36) may include standard butyl rubber material and may be coated with a biocompatible lubricating coating (e.g., polytetrafluoroethylene ("PTFE")) to facilitate favorable sealing and relative motion characteristics with respect to the associated syringe body structure and material. The proximal end of the syringe body (34) in Figure 5B includes a conventional integrated syringe flange (38) formed integrally with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and to be the entire circumference or a portion of the circumference around the syringe body (34). A partial flange is known as a "clipped flange". The other flange is known as the “full flange.” The flange is used to grip the syringe with the fingers and provides support for pushing the plunger to perform the injection. The syringe body (34) preferably comprises a translucent material such as glass or polymer. The plunger tip (36) may be positioned within the syringe body (34) to form a sealed volume within the chamber or reservoir (40) and to assist in the discharge of the associated fluid through the needle. The syringe body (34) may be defined as substantially cylindrical (i.e., so that the plunger tip 36, having a circular cross-sectional shape, establishes a seal with the syringe body (34)), or it may be configured to have other cross-sectional shapes such as elliptical.

[0006] Such assemblies are desirable because they can be standardized and precisely mass-produced by a few manufacturers in the world that can afford to meet all of the world's ever-changing regulations regarding filling, packaging, and the selection of materials that come into contact with pharmaceuticals / medicines, as well as the use of components. However, such simple configurations generally cannot meet the new global standards for single use, safety, auto-deactivation, and needle-stick prevention. For this reason, certain suppliers have moved towards more “vertically integrated” solutions, such as those shown in Figure 5C (41), which attempt to meet all or at least some of the standards in a single solution, and as a result of trying to meet those standards in a variety of situations, such products have significant constraints (including the constraints mentioned above with reference to Figures 3-4B), and can have relatively high inventory and usage costs.

[0007] Some medications are administered sequentially to multiple sites inside or on the surface of a patient's body during treatment. There is a need for administration systems that overcome the shortcomings of currently available configurations. In particular, there is a need for administration systems that continuously administer fluids or gels for the treatment of a single patient. Furthermore, such syringe assemblies should ideally be able to leverage the existing, relatively well-managed supply chains of conventionally available pre-filled syringes, cartridges, and other off-the-shelf components, as well as the corresponding assembly equipment and personnel. [Overview of the project]

[0008] The embodiments relate to infusion systems. In particular, the embodiments relate to infusion systems for the continuous administration of multiple doses of an injectable agent.

[0009] In one embodiment, the drug administration system includes a syringe body having a proximal and distal end, an interior of the syringe, and a syringe flange provided at the proximal end. The system also includes a drug placed inside the syringe. The system further includes a finger flange coupled to the syringe flange. Furthermore, the system includes a stopper member located inside the syringe. Furthermore, the system includes a plunger member coupled to the stopper member and at least partially located inside the finger flange. The system also includes a thumb pad coupled to the proximal end of the finger flange and operably coupled to the plunger member. The finger flange includes a finger flange body defining the interior of the finger flange and an opening side window. The finger flange also includes a ratchet configured to advance the plunger member by a preset longitudinal distance each time the thumb pad is fully pressed into the finger flange. The finger flange further includes a cam configured to rotate by a preset angular distance each time the thumb pad is fully pressed into the finger flange.

[0010] In one or more embodiments, the finger flange further comprises a stator operably coupled to a thumb pad and a cam, the stator configured to rotate the cam as the thumb pad is pushed into the finger flange. The cam may include at least one rotation indicator visible through a window in the finger flange body, which may be configured to indicate the number of times the thumb pad has been fully pushed into the finger flange. The system may also include a spring configured to return the thumb pad proximal after it has been pushed distally into the finger flange.

[0011] In one or more embodiments, the finger flange is configured to emit an audible indicator each time the thumb pad is fully pressed into the finger flange. The finger flange may be configured to prevent the thumb pad from being pressed further into the finger flange after it has been fully pressed into the finger flange a predetermined number of times. The system may also include a semi-rigid distal cap, which may include a shield body and an elastic member disposed within the shield body.

[0012] The above-described embodiments and other embodiments of the present invention are described in the following detailed description. [Brief explanation of the drawing]

[0013] This patent or application file includes at least one drawing made in color. A copy of this patent or patent application publication, including the color drawing, will be provided by the United States Patent and Trademark Office upon request and payment of the required fees. [Figure 1] Figures 1A and 1B show one embodiment of a conventional injection syringe configuration. [Figure 2] Figures 2A and 2B show one embodiment of a conventional injection syringe configuration. [Figure 3] Figure 3 shows one configuration of a conventional injection syringe. [Figure 4] Figures 4A and 4B show one embodiment of a conventional injection syringe configuration. [Figure 5] Figures 5A to 5C show one configuration of a conventional injection syringe. [Figure 6] Figure 6 is a longitudinal cross-sectional view of a multi-site administration system according to several embodiments. [Figure 7] Figure 7 is a detailed longitudinal cross-sectional view of the multi-site administration system shown in Figure 6. [Figure 8] Figure 8 is a detailed longitudinal cross-sectional view of the multi-site administration system shown in Figures 6 and 7, along a plane perpendicular to the cross-section in Figure 7. [Figure 9]Figure 9 is a longitudinal cross-sectional view schematically illustrating a series of operations that occur within the device when the thumb pad is fully pressed according to several embodiments of a multi-site administration system. [Figure 10] Figure 10 is a longitudinal cross-sectional view schematically illustrating a series of operations that occur within the device when the thumb pad is fully pressed according to several embodiments of a multi-site administration system. [Figure 11] Figure 11 is a longitudinal cross-sectional view schematically illustrating a series of operations that occur within the device when the thumb pad is fully pressed according to several embodiments of a multi-site administration system. [Figure 12] Figure 12 is a longitudinal cross-sectional view schematically illustrating a series of operations that occur within the device when the thumb pad is fully pressed according to several embodiments of a multi-site administration system. [Figure 13] Figure 13 is a perspective view of a multi-site administration system according to several embodiments. [Figure 14] Figures 14A and 14B are side views of a multi-site administration system including a removable cap according to several embodiments. [Figure 15] Figures 15A and 15B are side and longitudinal cross-sectional views of a removable cap according to several embodiments. [Figure 16] Figure 16 is a side view of a continuous administration system according to several embodiments. [Figure 17] Figure 17 is an exploded view of various components of the continuous administration system shown in Figure 16 according to several embodiments. [Figure 18] Figure 18 is a longitudinal cross-sectional view of the continuous administration system shown in Figure 16. [Figure 19] Figure 19A is a front perspective view of the continuous dispensing system shown in Figure 16 with the cap removed according to some embodiments. Figure 19B schematically shows the distal end of the continuous dispensing system shown in Figure 16 with the cap removed according to some embodiments dispensing fluid or gel onto the user's finger. [Figure 20]Figure 20 is a detailed longitudinal sectional view of the continuous administration system shown in Figure 16 during administration of one dose of fluid or gel. [Figure 21] Figure 21 is a detailed longitudinal sectional view of the continuous administration system shown in Figure 16 during administration of one dose of fluid or gel. [Figure 22] Figure 22 is a detailed longitudinal sectional view of the continuous administration system shown in Figure 16 during administration of one dose of fluid or gel. [Figure 23] Figure 23 is a side view of the thumb pad shaft of the continuous administration system of Figure 16. [Figure 24] Figures 24A and 24B are proximal and distal perspective views of the cam ring of the continuous administration system of Figure 16. [Figure 25] Figure 25 is a distal perspective view of the finger flange housing of the continuous administration system of Figure 16. [Figure 26] Figure 26 is a proximal perspective view of the finger flange housing of the continuous administration system of Figure 16. [Figure 27] Figure 27 is a proximal perspective view of the finger flange housing of the continuous administration system of Figure 16. [Figure 28] Figures 28A and 28B are distal perspective views of the distal and proximal portions of the ratchet of the continuous administration system of Figure 16. [Figure 29] Figure 29 is a distal perspective view of a ratchet for use in a continuous administration system according to some embodiments. [Figure 30] Figure 30 is an exploded view of the finger flange and components included therein of the continuous administration system of Figure 16 according to some embodiments. [Figure 31] Figure 31 is a side perspective view schematically showing a series of operations of the dose counting mechanism of the continuous administration system of Figure 16. [Figure 32] Figure 32 is a side perspective view schematically showing a series of operations of the dose counting mechanism of the continuous administration system of Figure 16. [Figure 33] Figure 33 is a side perspective view schematically showing a series of operations of the dose counting mechanism of the continuous administration system of Figure 16. [Figure 34] Figure 34 is a schematic side perspective view showing a series of operations of the administration counting mechanism of the continuous administration system shown in Figure 16. [Figure 35] Figure 35 is a schematic side perspective view showing a series of operations of the administration counting mechanism of the continuous administration system shown in Figure 16. [Figure 36] Figure 36 schematically shows a display placed on the dose count cam of a continuous dosing system according to several embodiments, including the continuous dosing system described herein. [Figure 37] Figure 37 schematically shows a display placed on the dose count cam of a continuous dosing system according to several embodiments, including the continuous dosing system described herein. [Figure 38] Figure 38 is a side view showing a continuous administration system equipped with a display showing various administration counts according to several embodiments. [Figure 39] Figure 39 is a side view showing a continuous administration system equipped with a display showing various dose counts according to several embodiments. [Figure 40] Figure 40 is a side view showing a continuous administration system equipped with a display showing various administration counts according to several embodiments. [Figure 41] Figure 41 is a longitudinal cross-sectional view along the orthogonal axis of a continuous administration system according to several embodiments. [Figure 42] Figure 42 is a longitudinal cross-sectional view along the orthogonal axis of a continuous administration system according to several embodiments. [Figure 43] Figure 43 is a detailed longitudinal cross-sectional view showing a single dose using a continuous administration system according to several embodiments. [Figure 44] Figure 44 is a detailed longitudinal cross-sectional view showing a single dose using a continuous administration system according to several embodiments. [Figure 45] Figure 45 is a distal perspective view of a dose count cam used in a continuous administration system according to several embodiments. [Figure 46]Figure 46 is a detailed longitudinal cross-sectional view showing the distal end of a continuous administration system fitted with a removable cap according to several embodiments. [Figure 47] Figure 47 is an exploded view of the removable cap shown in Figure 46. [Figure 48] Figure 48 is a side view of a continuous injection system according to several embodiments.

[0014] To better understand how the above and other advantages and objectives of various embodiments are obtained, a more detailed description of the embodiments is provided with reference to the accompanying drawings. Note that the drawings are not drawn to a fixed scale, and elements of similar structure or function are indicated by the same reference numerals throughout. It should be understood that these drawings merely illustrate specific exemplary embodiments and should not be considered to limit the scope of the embodiments. [Modes for carrying out the invention]

[0015] Exemplary continuous administration system Many medications can be administered to the same patient at multiple sites and / or multiple times by injection or topical application. Some medical procedures require the continuous administration of a fixed amount (e.g., in the range of 0.05 ml and / or microliters) of medication to multiple sites on the patient or as a topical application. Currently, many medications are drawn from vials into drug delivery systems, which increases procedure time and the risk of unintentional puncture due to exposure of the sharp distal end of the needle. Furthermore, some medications are delivered from drug tubes, in which case it is difficult for the patient to determine the exact dosage in microliter units, and thus the patient may visually over- or under-administer the medication. The continuous administration systems described herein address the shortcomings of these current systems.

[0016] Figures 6 to 15B show continuous administration systems 600 according to several embodiments.

[0017] As shown in Figure 6, the continuous administration system 600 includes a system body 34, a finger flange body 605 coupled to the system body 34, a stopper member 36 located inside the system body 34, and a plunger member 44 coupled to the stopper member 36. The system body 34 has a system body flange 33 located at its proximal end. The finger flange body 605 is coupled to the system body flange 33. The system body 34 also has an open distal end 37. The system body 34 can also be composed of a syringe or cartridge body. The system body 34 can be made of glass or plastic material, thereby allowing the drug to be pre-filled inside for storage, transport, and use.

[0018] The system 600 also includes a thumb pad member 601 configured to apply a distal force to the plunger member 44 and the stopper member 36 coupled thereto. The thumb pad member 601 has a thumb pad tubular member 602 at its distal end. Furthermore, the system 600 includes a cam 604 slidably disposed within the finger flange body 605, which is configured to advance and rotate axially relative to the inner surface of the finger flange body 605. Furthermore, the system 600 includes a ring stator 606 fixedly disposed within the finger flange body 605 proximal to the cam 604.

[0019] The finger flange body 605 includes two springs: a proximal spring 603 positioned around the thumb pad tubular member 602 on the proximal side of the ring stator 606, and a distal spring 607 positioned at the distal end inside the finger flange body 605 on the distal side of the cam 604. The proximal spring 603 is configured to act distally on the ring stator 606 and proximal on the thumb pad member 601. The distal spring 607 is configured to act proximal on the distal surface of the cam 604. Under the action of the proximal and distal springs 603 and 607, the thumb pad member 601, the ring stator 606, and the cam 604 are normally pushed proximal within the finger flange body 605 by the distal spring 607 and the proximal spring 603.

[0020] Figure 7 is a detailed longitudinal cross-sectional view of the continuous dispensing system 600 shown in Figure 6. As shown in Figure 7, the ratchet 609 is partially located within the cam 604 and coupled to the cam. The ratchet 609 within the cam member 604 includes a plurality of arms 610 that taper distally. Thus, as the cam 604 moves distally, the plurality of arms 610 of the ratchet 609 push the ribs 45 and the plunger member 44 on which they are provided distally. When the cam 604 returns proximal by the distal spring 607, the plurality of arms 610 of the ratchet 609 can move proximal over the ribs 45 of the plunger member 44 without moving the plunger member. When the plunger member 44 is advanced, a preset or metered amount of fluid or gel, which is located within the system body 34 and configured to be supplied from the system body, can be discharged. The size of the preset or metered amount of fluid or gel can be adjusted by changing the spacing of the ribs 45 of the plunger member 44. When the ratchet 609 and its multiple arms 610 are returned to the adjacent position proximal to the next rib 45 of the plunger member 44, the system 600 is ready to continuously discharge the next dose of fluid or gel.

[0021] Figure 8 is a detailed longitudinal cross-sectional view of the continuous dispensing system 600 shown in Figures 6 and 7, along a plane perpendicular to the cross-section in Figure 7. As shown in Figure 8, the proximal end of the cam 604 and the distal surface of the ring stator 606 are provided with a plurality of corresponding meshing teeth 604-1, 606-1, respectively. The distal spring 607 applies a force to the cam 604 in the proximal direction and maintains pressure at the interface between the cam 604 and the ring stator 606. This pressure maintains the plurality of corresponding meshing teeth 604-1, 606-1 in a meshed state, as shown in Figure 8.

[0022] Figures 9 to 12 illustrate an exemplary method of operating the continuous dispensing system 600 to advance the plunger member 44, discharging a preset dose of fluid or gel from the system body 34, and preparing the system 600 for continuous discharging of the next dose of fluid or gel. Figures 9 to 12 are longitudinal cross-sectional views of the continuous dispensing system 600 shown in Figures 6 to 8, along the same cross-section as in Figure 7. In Figures 9 to 12, the system elements are denoted by the same reference numerals as in Figures 6 to 8. Figures 9 to 12 also include detailed partial enlarged views showing the interaction between a plurality of meshing teeth 604-1, 604-2, 604-3 at the proximal end of the cam 604 and the corresponding plurality of meshing teeth 606-1 at the distal end of the ring stator 606 at various steps of the method.

[0023] Figure 9 is a detailed longitudinal cross-sectional view of the continuous dispensing system 600 shown in Figures 6-8 in the retracted / proximal / ready state. A partially enlarged view of Figure 9 shows the corresponding multiple meshing teeth 604-1, 604-2, 604-3, and 606-1. When the device is in its retracted / proximal / ready state, no pressure is applied to the thumb pad member 601. Therefore, the cam 604 is rotationally coupled to the ring stator 606 by the corresponding multiple meshing teeth 604-1, 604-2, 604-3, and 606-1. For example, tooth 604-2 of the cam 604 interferes with tooth 606-1 of the ring stator 606, thereby preventing relative rotation of the cam 604 and the ring stator 606 in one direction.

[0024] Figure 10 is a detailed longitudinal cross-sectional view of the continuous administration system 600 in the administration initiation state. The user can move the continuous administration system 600 from the retracted / proximal / ready state shown in Figure 9 to the administration initiation state shown in Figure 10 by applying distal force to the thumb pad member 601. In Figure 10, the thumb pad member 601 is advancing distally, but has not yet reached its most distal position. Therefore, the distal end of the thumb pad tubular member 602 of the thumb pad member 601 has just made contact with the proximal surface of the cam 604, and has just begun to move the cam 604 distally away from the ring stator 606. As shown in the partially enlarged view of Figure 10, the cam 604 is beginning to move distally away from the ring stator 606. As the thumb pad tubular member 602 of the thumb pad member 601 moves further distally, the cam 604 will inevitably move distally together with the thumb pad tubular member 602 while remaining in contact with it. In the initial administration state, the thumb pad member 601 has not fully advanced to its most distal position, and the tubular member of the thumb pad 602 has not advanced to its most reachable distal position. Therefore, the cam 604 has not reached its most distal position and remains in contact with the ring stator 606, preventing relative rotation between the cam 604 and the ring stator 606.

[0025] Figure 11 is a detailed longitudinal cross-sectional view of the continuous administration system 600 in the administration completion state. The user can transition the continuous administration system 600 from the administration start state shown in Figure 10 to the administration completion state shown in Figure 11 by continuously applying distal force to the thumb pad member 601. In the administration completion state, if distal force is continuously applied to the thumb pad member 601, the thumb pad member 601 and the thumb pad tubular member 602 will advance to their respective distal positions. Since the thumb pad tubular member 602 is in contact with the cam 604, when the thumb pad tubular member 602 is advanced to its distal position, the cam 604 also advances to its distal position. As shown in the partially enlarged view of Figure 11, when the cam 604 advances distally, the teeth 604-1, 604-2, and 604-3 of the cam 604 move distally away from the tooth 606-1 of the ring stator 606 and no longer make contact / interference. As shown in the enlarged section of Figure 11, in the completed dosing state, the teeth 604-1, 604-2, and 604-3 of the cam 604 are positioned and configured to mesh with the tooth 602-1 (see Figure 7) at the distal end of the thumb pad tubular member 602 of the thumb pad member 601, which is circumferentially inward of the cam 604 and the ring stator 606. The teeth 604-1, 604-2, and 604-3 of the cam 604 and the tooth 602-1 of the thumb pad tubular member 602 are rotationally offset, and a proximal force from the distal spring 607 causes the cam 604 to move proximal and rotate clockwise when viewed from the distal end of the continuous dosing system 600. The rotation of the cam 604 is caused / controlled by the relative pitch / taper of their teeth 604-1, 604-2, 604-3, and 602-1. The proximal movement and rotation of the cam 604 can generate an audible indicator when the cam 604 interacts with the teeth 602-1 of the thumb pad tubular member 602. The cam 604 and the thumb pad tubular member 602 are configured to generate an audible indicator when the administration system 600 is in an administration complete state, thereby notifying the user of the completion of administration with an audible indicator.

[0026] Figure 12 is a detailed longitudinal cross-sectional view of the continuous dosing system 600 in the thumb pad retracted / proximal / ready state. The user can move the continuous dosing system 600 from the dosing completion state shown in Figure 11 to the thumb pad retracted / proximal / ready state shown in Figure 12 by releasing the distal force applied to the thumb pad member 601. When the distal force from the thumb pad member 601 is released, the distal spring 607 pushes the cam 604 back in the proximal direction, allowing it to re-contact the ring stator 606. The teeth 606-1 of the ring stator 606 and the teeth 604-1, 604-2, and 604-3 of the cam 604 interact with each other, and this proximal movement of the cam 604 causes the teeth 604-1, 604-2, and 604-3 of the cam 604 to mesh with the tooth 602-1 of the ring stator 606, while simultaneously causing the cam 604 to rotate clockwise. The amount of rotation resulting from the meshing of teeth 604-1, 604-2, and 604-3 of cam 604 and tooth 606-1 of ring stator 606 is caused by / controlled by the relative pitch / taper of these teeth 604-1, 604-2, 604-3, and 606-1. When the continuous dispensing system 600 is in the thumb pad retracted / proximal / ready state, the proximal spring 603 resets the thumb pad member 601 to its retracted / proximal / ready position as shown in Figures 9 and 12. The difference between the states of the continuous dispensing system 600 shown in Figures 9 and 12 is that (1) cam 604 is rotated clockwise by one tooth of teeth 604-1, 604-2, and 604-3, and (2) a single dose of fluid or gel is discharged from the open distal end 37 of the system body 34 by the advancing stopper member 36.

[0027] Figure 13 is a perspective view of the proximal end of a continuous dosing system 600 according to several embodiments, such as the continuous dosing system 600 shown in Figures 6 to 12. The continuous dosing system 600 includes a finger flange body 605 that defines an indicator window 612 through which a portion of the cam 604 is visible. As the cam 604 rotates during a series of dosing operations, different portions of the cam 604, which function as visible indicators 614, become visible through the indicator window 612. Therefore, multiple visible indicators 614 can be provided on the cam 604 to indicate the rotational position of the cam 604 and the approximate number of remaining and completed dosings.

[0028] Figures 14A and 14B are side views of a multi-site administration system including a removable cap 620, as exemplified by several embodiments, such as the continuous administration system 600 shown in Figures 6 to 13. As shown in Figure 14A, when the removable cap 620 is coupled to the system body 34, the open distal end 37 (see Figure 14B) is protected from contamination. The removable cap can also protect against accidental administration of fluid or gel.

[0029] Figures 15A and 15B are side and longitudinal cross-sectional views of a removable cap 620 according to several embodiments. The removable cap 620 includes a rigid outer shell 622 and a curved elastic liner 624 (see Figure 15B) located within the rigid outer shell 622, thereby allowing the removable cap 620 to be secured on the open distal end 37 of the system body 34 (see Figure 14B).

[0030] Figures 16 to 37 show a continuous administration system 1600 having a single helical spring 1607 according to several embodiments. The continuous administration system 1600 shown in Figures 16 to 37 is similar to the continuous administration system 600 shown in Figures 6 to 15, and similar components are denoted by the same or similar reference numerals.

[0031] Figure 16 is a side view showing a continuous administration system 1600 according to several embodiments. The continuous administration system 1600 includes a system body 34, a finger flange body 1605 coupled to the system body 34, and a removable cap 1620 coupled to the distal end of the system body 34. The system body 34 has a system body flange 33 located at its proximal end. The system body 34 also has an open distal end 37, as shown in Figure 18. The system body 34 can be composed of a syringe or a cartridge body. The system body 34 can be formed from glass or plastic material, thereby allowing the inside to be pre-filled with medication for storage, transport, and use.

[0032] The finger flange body 1605 is coupled to the system body flange 33. The finger flange 1605 defines an indicator window 1612 that allows a portion of the cam 1604, which functions as a visible indicator 1614, to be viewed. The system 1600 also includes a thumb pad member 1601 configured to apply distal force to the continuous dispensing system 1600.

[0033] Figure 17 is an exploded view of various components of the continuous dispensing system 1600 shown in Figure 16 according to several embodiments. In addition to the components of the continuous dispensing system 1600 described above, Figure 17 also shows a stopper member 36 located within the system body 34. A plunger member 44 with multiple ribs 45 is also shown. Furthermore, a finger flange 1605 is shown together with a thumb pad member 1601 located within it.

[0034] Figure 18 is a longitudinal cross-sectional view of the continuous dispensing system 1600 shown in Figure 16. In addition to the components of the continuous dispensing system 1600 described above, Figure 18 shows a helical spring 1607 and part of the plunger member 44 positioned around the distal end of the thumb pad member 1601. Figure 18 also shows a ratchet 1609 positioned within the finger flange 1605 and configured to move distally by the thumb pad member 1601. The ratchet 1609 has a plurality of arms 1610 that taper distally. Thus, as the thumb pad member 1601 moves distally, the plurality of arms 1610 of the ratchet 1609 push the rib 45 and the plunger member 44 on which it is provided distally, thereby discharging a preset / metered amount of fluid or gel from the system body 34.

[0035] Figure 19A is a front perspective view of the continuous dispensing system 1600 shown in Figure 16 with the cap 1620 (see Figure 16) removed, according to one of several embodiments. Figure 19B schematically shows the distal end of the continuous dispensing system 1600 shown in Figure 16 with the cap 1620 (see Figure 16) removed, dispensing a fluid or gel onto the user's finger (for example, for topical application), according to one of several embodiments.

[0036] Figures 20–22 are detailed longitudinal cross-sectional views of the continuous dispensing system shown in Figure 16 during the administration of a single dose of fluid or gel. Figure 20 shows in more detail the thumb pad member 1601, which includes a thumb pad rotating ramp 1630, a stop surface 1634, a ratchet contact patch 1636, and a pair of hooks 1637 (see also Figure 23), in addition to the components of the continuous dispensing system 1600 described above. As shown in Figure 23, the thumb pad member 1601 also defines a pair of stator notches 1626 (only one is shown).

[0037] Figure 20 also shows a more detailed view of the cam 1604, which includes multiple cam rotation ramps 1632 and visible indicators 1614 (see also Figures 24A and 24B). Figures 24A and 24B further show the cam lockout rib 1629 and multiple stator bypass grooves 1638.

[0038] Figure 20 shows the continuous dispensing system 1600 in a retracted / proximal / ready state, ready for dispensing fluid or gel. In the retracted / proximal / ready state, the helical spring 1607 extends, pushing the cam 1604 in the proximal direction, so that the cam rotation ramp 1632 is in contact with the thumb pad rotation ramp 1630, and the cam bypass groove 1638 (see Figures 24A and 24B) is in contact with the stator rib 1644 (see Figure 26). The ratchet contact patch 1636 is not in contact with the ratchet 1609. The helical spring 1607 pushes the cam 1604 and the thumb pad member 1601 in the proximal direction, thereby pulling the interconnected ratchet 1609 in the proximal direction via the hook 1637 until the retaining tab 1613 of the ratchet 1609 (see Figure 29B) contacts the proximal surface of the retaining slot 1648 defined by the finger flange 1605 (see Figure 27A).

[0039] Figure 21 shows the continuous administration system 1600 in the administration initiation state. The user can move the continuous administration system 1600 from the retracted / proximal / ready state shown in Figure 20 to the administration initiation state shown in Figure 21 by applying distal force to the thumb pad member 1601. In Figure 21, the thumb pad member 1601 is advancing distally, but has not yet reached its most distal position. Therefore, the ratchet contact patch 1636 of the thumb pad member 1601 has just made contact with the proximal surface of the ratchet 1609, and has just begun to move the ratchet 1609 distally. In the administration initiation state, the thumb pad member 1601 has not fully advanced to its most distal position. Therefore, the cam 1604 and ratchet 1609 have not yet moved to their most distal positions. If the thumb pad member 1601 is further advanced distally, the cam 1604 and ratchet 1609 will inevitably move distally as well.

[0040] Figure 22 shows the continuous administration system 1600 in the administration completion state. The user can transition the continuous administration system 1600 from the administration start state shown in Figure 21 to the administration completion state shown in Figure 22 by continuously applying distal force to the thumb pad member 1601. In the administration completion state, by continuing to apply distal force to the thumb pad member 1601, the thumb pad member 1601, the cam 1604, and the ratchet 1609 each advance to their most distal positions. The distal movement of the ratchet 1609 stops when the ratchet stop tab 1615 (see Figure 28B) reaches the bottom surface 1646 of the stop channel defined by the finger flange 1605 (see Figure 27A). When a distal force is continuously applied to the thumb pad member 1601, the leaf spring 1636 of the thumb pad member 1601 (see Figures 23, 43, and 44) ​​is compressed, allowing the cam 1604 to move further distally until the cam bypass groove 1638 separates from the stator rib 1644, thereby allowing the cam 1604 to rotate clockwise when viewed from the distal end of the continuous dosing system 1600. The further movement of the cam 1604 facilitated by the compression of the leaf spring 1636 provides tolerances to the various system elements connecting the cam 1604 and the ratchet 1609. Further movement of the cam 1604 requires additional force from the user (e.g., force via the user's thumb), thereby creating a pseudo-motion sensation during the dosing cycle.

[0041] The rotation of cam 1604 is caused by the interaction between the thumb pad rotation ramp 1630 and the cam rotation ramp 1632, which is currently in contact with it. As cam 1604 rotates, a visible indicator 1614, visible through an indicator window (not shown, see Figure 16), changes. As cam 1604 rotates, an audible indicator is also generated as the cam rotation ramp 1632 slides and collides with the stop surface 1634 of the thumb pad rotation ramp 1630. Cam 1604 and thumb pad rotation ramp 1630 are configured to generate an audible indicator when the administration system 1600 is in an administration complete state, which can inform the user of the completion of administration.

[0042] As the thumb pad member 1601 advances to its most distal position, the distal force transmitted through the ratchet contact point 1636 of the thumb pad member 1601 causes the ratchet 1609 and its multiple arms 1610 to also advance to their respective most distal positions. The multiple arms 1610 advancing distally push the rib 45 and the plunger member 44 on which it is provided, thereby discharging a preset / metered amount of fluid or gel from the system body 34, completing a single dose of the preset / metered amount of fluid or gel. The plunger member 44 and the connected stopper 36 move distally to define the amount dispensed.

[0043] The distal movement of the plunger member 44 is determined by the pitch of the ribs 45 of the plunger member 44. The arm 1610 of the ratchet 1609 contacts the ribs 45 and moves within a range of 1 to 2 times the pitch between the ribs 45 (i.e., greater than one rib space but less than two rib spaces). After administration, the plunger member 44 and the interconnected ratchet 1609 move proximal, and when the user releases the thumb pad member 1601, the difference between the movement of the plunger member 44 and the movement of the ratchet 1609 ensures that the ratchet engages with the next proximal rib 45. The movement of the ratchet is the difference between the dimension from the ratchet stop tab 1615 to the ratchet retaining tab 1613 (i.e., dimension A shown in Figure 28B) and the dimension from the bottom surface of the stop channel 1646 to the proximal surface of the retaining slot 1648 (i.e., dimension B shown in Figure 27B). The difference between dimension A and dimension B (i.e., AB) is the amount of travel of the ratchet 1609 in one dosing cycle. In some embodiments, the pitch of the ribs 45 of the plunger member 44 is approximately 1 / 1,000 of an inch.

[0044] When the distal force applied to the thumb pad member 1601 is released (see also Figures 18 and 34-35), the helical spring 1607 returns the thumb pad member 1601 proximal, pulling the ratchet 1609 proximal via the hook 1637, thereby causing the arm 1610 of the ratchet 1609 to jump to the next proximal rib 45 of the plunger member 44, and the continuous dosing system 1600 is reset for the next dosing event.

[0045] Figures 25-27 are distal (Figure 25) and proximal (Figures 26 and 27) perspective views of the finger flange 1605. In addition to the components of the continuous dosing system 1600 described above, Figure 25 shows a stator rotation ramp 1640 extending from the distal end of the stator rib 1644 (see Figures 26 and 27) and configured to complete the rotation of the cam 1604 at the end of the dosing cycle (as described later). Figure 26 shows a lockout receiver 1642 configured to prevent further movement of the thumb pad member 1601 and rotation of the cam 1604 after a preset number of dosing cycles have been completed (as described later). Figures 26 and 27 also show a pair of stator ribs 1644 (see Figure 23) configured to interfere with a corresponding pair of stator notches 1628 (in some situations described later) to prevent rotation of the thumb pad member 1601 and the cam 1604 relative to the finger flange 1605.

[0046] Figures 28A and 28B show a two-part ratchet 1609 used in a continuous dispensing system 1600 according to several embodiments. The two-part ratchet 1609 includes a proximal portion 1609-1 which can be formed from a polymer and a distal portion 1609-2 which can be formed from a metal / alloy such as stainless steel. The proximal portion 1609-1 of the two-part ratchet 1609 also defines a pair of longitudinal slots 1611 (only one shown) for receiving a corresponding pair of hooks 1637 at the distal end of a thumb pad member 1601. The distal portion 1609-2 of the two-part ratchet 1609 also defines the plurality of arms 1610 described above. The arms 1610 are configured to elastically deform around the outer diameter of the plunger member 44 and engage with the ribs 45 of the plunger member 45 when dispensing a fluid or gel. When administration is performed, the ratchet 1609 is configured to move proximal by a helical spring 1607, and the arm 1610 snaps onto the next most proximal rib 45 after the plunger member 44 and engages with the rib 45, preparing the system 1600 for the next administration. The ratchet 1609 includes a plurality of ratchet stop tabs 1615 and ratchet retaining tabs 1613.

[0047] Figure 29 shows an integrated ratchet 1609' used in a continuous dispensing system 1600 according to several embodiments. The ratchet 1609' can be formed from a polymer. The ratchet 1609' also includes a pair of longitudinal slots 1611 (only one shown) for receiving a corresponding pair of hooks 1637 at the distal end of a thumb pad member 1601. Furthermore, the ratchet 1609' is provided with the aforementioned multiple arms 1610'. The arms 1610' are formed from a polymer and integrated with the ratchet 1609'. The arms 1610' are configured to elastically deform to fit around the outer diameter of the plunger member 44 and to engage with the ribs 45 of the plunger member 45 during fluid or gel dispensing. The ratchet 1609' further comprises a plurality of ratchet stop tabs 1615 and ratchet retaining tabs 1613.

[0048] Figure 30 is an exploded view of the finger flange 1605 of the continuous administration system 1600 and the components contained therein. The components contained in the finger flange 1605 include (from proximal to distal) a thumb pad member 1601, a cam 1604, a helical spring 1607, and a ratchet 1609.

[0049] Figures 31 to 35 are schematic side perspective views illustrating a series of operations of the dosing count mechanism of the continuous dosing system 1600 of Figure 16. The dosing count mechanism includes a cam 1604, which is configured to rotate by a preset angle each time the thumb pad member 1601 advances distally to administer a dose. The dosing count mechanism also includes a stator rotation ramp 1640 (see Figure 25) located on the inner surface of the finger flange 1605 and a thumb pad rotation ramp 1630 (see Figure 23) located on the outer surface of the thumb pad member 1601.

[0050] Figure 31 shows a stationary counting mechanism in which the cam 1604 is sandwiched between the thumb pad rotation ramp 1630, the stator rotation ramp 1640, and the stator rib 1644, preventing the rotation of the cam 1604.

[0051] Figure 32 shows the counting mechanism after sufficient distal force has been applied to the thumb pad member 1601, causing the thumb pad member 1601 and the cam 1604 to disengage from contact with the stator rotation ramp 1640 and the stator rib 1644. At this point, the counting mechanism is in a rotating state. In this rotating state, the interaction between the thumb pad rotation ramp 1630 and the cam rotation ramp 1632 causes the cam to begin rotating clockwise when viewed from the distal end of the continuous injection device 1600. As the ratchet contact patch 1636 is in contact with the ratchet 1609 via the leaf spring 1639, dosing begins at this stage as the thumb pad member 1601 moves distally, causing the plunger member 44 and stopper member 36, which are interconnected with the ratchet 1609, to move distally, and the fluid or gel is discharged from the system body 34.

[0052] Figure 33 shows the counting mechanism after a distal force is applied to the thumb pad member 1601, causing the cam 1604 to rotate until the next cam rotation ramp 1632 contacts the stop surface 1634 of the thumb pad rotation ramp 1630. At this point, the cam 1604 has rotated approximately half the preset amount of rotation for one administration cycle. At this point, the administration operation is complete.

[0053] Figure 34 shows the counting mechanism after the distal force applied by the thumb pad member 1601 has been removed and the helical spring 1607 (see Figures 20 and 30) has begun to return the cam 1604 and the thumb pad member 1601 distally. As the cam 1604 returns distally, the cam rotation ramp 1632 interacts with the stator rotation ramp 1640, completing the rotation of the cam 1604, which had rotated half a turn in this dosing cycle.

[0054] Figure 35 shows how the counting mechanism returns to a stationary state due to the extension of the previously compressed helical spring 1607 (see Figures 20 and 30). The stationary state shown in Figure 35 is similar to the stationary state shown in Figure 31, in that the cam 1604 is sandwiched between the thumb pad rotation ramp 1630, the stator rotation ramp 1640, and the stator rib 1644, preventing the rotation of the cam 1604. However, the cam 1604 has rotated clockwise by a preset amount. At this point, the dosing cycle is complete, and the cam 1604 has rotated so that the visible display indicator 1614-1 is visible through the indicator window 1612 of the finger flange 1605. The amount of cam rotation per dosing cycle can be controlled by adjusting the relative size and shape of the thumb pad rotation ramp 1630, the cam rotation ramp 1632, and the stator rotation ramp 1640. When in this state, the ratchet 1609 is pulled proximal by a dropper spring 1607 connected to the cam 1604 and thumb pad member 1601 via a hook 1637, thereby engaging the ratchet arm 1610 with the next most proximal rib 45 of the plunger member 44.

[0055] Figures 36 and 37 show various visible indicators 1614-A, 1614-B, 1614-C, 1614-D, 1614-E, 1614-F, 1614-G, 1614-H, and 3614, which can be attached to the cam of a continuous infusion system to provide various visible indicators of the status of the continuous infusion system. In a particular dosing system, when the last preset dosing cycle is completed, a visible indicator (e.g., "0") can be seen through the display window. This visible indicator may include a color to indicate that the last preset dosing cycle has been completed.

[0056] In a particular administration system, once the last preset administration cycle is complete, the cam lockout rib 1629 of cam 1604 (see Figures 24A and 24B) interferes with the lockout receiver 1642 (see Figure 26) located inside the finger flange 1605, preventing proximal movement of cam 1604 relative to the finger flange 1605. By preventing proximal movement of cam 1604, the cam bypass groove 1638 is prevented from advancing distally beyond the stator rib 1644, thereby preventing rotation of the cam. Once rotation of the cam is prevented, further administration cycles are "locked out" after a preset number of administration cycles by the administration system 1600. The preset number of administration cycles can be controlled by adjusting the cam lock and lockout receiver 1642 of cam 1604 and rib 1629.

[0057] Figures 38 to 47 show a continuous administration system 3800 having a single helical spring 1607 according to several embodiments. The continuous administration system 3800 shown in Figures 38 to 47 is very similar to the continuous administration system 1600 shown in Figures 16 to 37, and similar components are denoted by the same or similar reference numerals. Three differences between the continuous administration system 3800 shown in Figures 38 to 47 and the continuous administration system 1600 shown in Figures 16 to 37 are (1) the use of an integrated ratchet 1609' shown in Figure 29, (2) the presence of a distal connector 39 on the system body, and (3) a cap 3820 of a different design.

[0058] Figures 41 to 44 show how the plunger member 44 is advanced by the interaction between the arm 1610' of the integrated ratchet 1609' and the rib 45 of the plunger member of the continuous dosing system 3800, using the integrated ratchet 1609'.

[0059] Figures 38 to 42 and 46 to 47 show the distal connector 39 of the system body 34 of the continuous administration system 3800. In some embodiments, the distal connector 39 of the system body may be a male threaded connector.

[0060] Figures 46 and 47 show a cap 3820 used in the continuous dosing system 3800. The cap 3820 may have a rigid outer shell 3822 and an elastic insert 3824. The cap 3820 may also have a female thread at its proximal end, which is configured to cooperate with the male thread system body connector 39 to connect the cap 3822 to the male thread system body connector 39 and the system body 34.

[0061] As shown in Figure 45, the continuous dosing system 3800 includes a visible indicator 3814 located on its cam 1604. Figure 38 shows the continuous dosing system 3800 in storage / transportation state, in which the visible indicator 3814-1 is visible through the display window 1612. In storage / transportation state, the continuous dosing system 3800 must undergo one or more dosing cycles to expel air / dead space from the open distal end 37 of the system body 34.

[0062] Figure 39 shows the continuous administration system 3800 in a ready-to-use state, in which the visible display 3814-2 is visible through the display window 1612. In the ready-to-use state shown in Figure 39, the continuous administration system 3800 has a number of doses (e.g., 18 doses) corresponding to the visible display 3814-2.

[0063] Figure 40 shows the continuous dosing system 3800 in a fully administered state, in which the visible indicator 3814-3 is visible through the display window 1612. In the fully administered state shown in Figure 40, the number of doses (e.g., 0 doses) corresponding to the visible indicator 3814-3 remains in the continuous dosing system 3800. In this embodiment, the number of remaining doses is shown, but in another embodiment of the device, the number of doses already administered may be shown. In addition to, or instead of, numerical displays of the remaining or administered doses, pictograms and / or bar or line graphs may be used. These displays may also indicate the administration of de-airing the distal end of the system body in preparation for administration for injection of the device, and / or attaching the needle for injection. In this state, the cam lockout rib 1629 on the cam 1604 (see Figures 24A and 24B) interferes with the lockout receiver 1642 (see Figure 26) located inside the finger flange 1605, thereby preventing the cam 1604 from moving proximal to the finger flange 1605 and "locking out" the administration system 3800.

[0064] This specification has described various administration systems 600, 1600, and 3800 as systems for discharging fluid or gel from the open distal end 37 of the system body 34. However, various components of the administration systems 600, 1600, and 3800 described herein can also be used in infusion systems such as the infusion system 4800 shown in Figure 48. The continuous administration system 4800 shown in Figure 48 is very similar to the continuous administration systems 1600 and 3800 shown in Figures 16-37 and 38-47, and similar components are denoted by the same or similar reference numerals. The difference between the continuous administration system 4800 shown in Figure 48 and the continuous administration systems 1600 and 3800 shown in Figures 16-37 and 38-47 is that a needle 4626 is connected to the system body connector 39 instead of a cap 3820, thereby converting the administration system 3800 into an infusion system 4800.

[0065] The injection systems disclosed and described herein include syringes with Luer connectors, but the multi-site injection systems described herein can also be used in combination with stake needles, cartridges, pen-type injectors or automatic injectors, etc. Furthermore, the multi-site injection systems described herein can also be used in combination with safety injection systems.

[0066] This specification describes various exemplary embodiments of the present invention. These examples are used in a non-limiting sense. They are provided to illustrate broader applicable aspects of the present invention. Various modifications can be made to the described invention and replaced with equivalents without departing from the true spirit and scope of the invention. Furthermore, many modifications can be made to adapt specific situations, materials, substance compositions, processes, process operations, or steps to the object, spirit, or scope of the invention. Moreover, as will be understood by those skilled in the art, each of the individual variations described and illustrated herein has separate components and features that can be readily separated from or combined with any of the features of several other embodiments without departing from the scope or spirit of the invention. All such modifications are intended to fall within the scope of the claims relating to this disclosure.

[0067] Any of the devices described for performing the diagnostic or intervention procedure in question may be provided in a packaged combination for use when performing such intervention. These supply “kits” may further include instructions for use and may be packaged in sterile trays or containers as commonly employed for such purposes.

[0068] The present invention includes methods that can be performed using the device of interest. These methods may include the act of providing such a suitable device. Such provision may be performed by an end user. That is, the act of “providing” simply requires the end user to take, access, approach, position, set up, start, power on, or perform other actions in order to provide the required device in the method of interest. The methods described herein may perform the described events in any logically possible order, or in the order of the described events.

[0069] Exemplary embodiments of the present invention, along with details relating to the selection and manufacture of materials, are described above. Further details of the present invention are generally known or understandable to those skilled in the art, as well as being understandable in connection with the previously cited patents and publications. For example, those skilled in the art will understand that one or more lubricating coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone compositions, fluoropolymers such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels, or silicones) can be used in relation to various parts of a device, such as relatively large interfaces of movably bonded parts, thereby facilitating, for example, low-friction operation or advancement of such objects against other parts of the instrument or nearby tissue structures. The same would apply to embodiments based on the methods of the present invention with respect to additional actions that are generally or logically employed.

[0070] Furthermore, while the present invention has been described with reference to several examples that arbitrarily incorporate various features, the present invention is not limited to those described or disclosed as intended with respect to each variation of the present invention. Various modifications can be made to the described invention without departing from the true spirit and scope of the invention, and equivalents can be substituted (whether described herein or not included for brevity). Furthermore, where a range of values ​​is provided, it should be understood that all intermediate values ​​between the upper and lower limits of that range, and other described or intermediate values ​​within the described range, are included within the scope of the present invention.

[0071] Furthermore, any feature of the variations of the present invention described herein is intended to be described and asserted independently or in combination with any one or more features of those described herein. References to singular items include the possibility of multiple instances of the same item. More specifically, in this specification and the accompanying claims, the singular forms “a,” “an,” “said,” and “the” include multiple references unless otherwise specified. In other words, the use of articles, as in the claims accompanying this disclosure, allows for “at least one” of the subject items in the above description. It should be noted that such claims may be drafted to exclude optional elements. For this reason, this statement is intended to serve as a prior reference to use exclusive terms such as “single,” “only,” or “negative” limitations in relation to the enumeration of elements of a claim.

[0072] Without using such exclusive terminology, the term “including” in the claims accompanying this disclosure shall enable the inclusion of any additional elements, regardless of whether a given number of elements are enumerated in such claims or whether the addition of features is deemed to alter the nature of the elements described in such claims. Unless otherwise specifically provided herein, all technical and scientific terms used herein shall be given meanings that are as broadly and generally understood as possible, while maintaining the validity of the claims.

[0073] The scope of the present invention is not limited to the examples and / or subject matter specifications provided, but rather is limited only by the language of the claims accompanying this disclosure.

Claims

1. A drug administration system, A syringe body having a proximal end, a distal end, the inside of the syringe, and a syringe flange provided at the proximal end, The drug placed inside the syringe, A finger flange coupled to the syringe flange, which defines the windows inside and on the sides of the finger flange, The stopper member is placed inside the syringe, A plunger member coupled to the stopper member and at least partially positioned within the finger flange, A thumb pad is slidably positioned at the proximal end of the finger flange and operably coupled to the plunger member, Each time the thumb pad is fully pushed into the finger flange, a cam is configured to rotate by a predetermined angular distance, A drug administration system comprising a ratchet configured to advance the plunger member by a predetermined longitudinal distance each time the thumb pad is fully pushed into the finger flange.

2. In the system described in claim 1, The system is characterized in that the finger flange further comprises a stator operably connected to the thumb pad and the cam, the stator being configured to rotate the cam by pushing the thumb pad into the finger flange.

3. In the system described in claim 1, The system is characterized in that the cam has at least one rotation indicator visible through a window in the finger flange body, and is configured to indicate the number of times the thumb pad has been fully pushed into the finger flange.

4. In the system described in claim 1, The system is further characterized by comprising a spring configured to return the thumb pad to its proximal position after the thumb pad has been pushed distally into the finger flange.

5. In the system described in claim 1, A system characterized in that the finger flange is configured to emit an audible indicator each time the thumb pad is fully pressed into the finger flange.

6. In the system described in claim 1, The system is characterized in that the finger flange is configured to prevent the thumb pad from being pushed further into the finger flange after the thumb pad has been fully pushed into the finger flange a predetermined number of times.

7. In the system described in claim 1, It further comprises a semi-rigid distal cap, and the distal cap is The shield body and A system characterized by comprising a curved elastic member disposed within the shield body.

8. In the system described in claim 1, The system is further characterized by comprising a needle attached to the distal end of the syringe body.

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