Systems and methods for administration or injection to multiple sites

Abstract

The fluid delivery system includes a syringe body having a proximal end and a distal end, an interior of the syringe, and a syringe flange provided at the proximal end. Further, the system includes a finger flange coupled to the syringe flange. Further, the system includes a stopper member disposed within the syringe. Further, the system includes a plunger member coupled to the stopper member and having a ratchet portion. Also, the system includes a push member coaxially disposed around at least a portion of the plunger member and operably coupled to the plunger member, the push member having an outer telescoping member disposed at its proximal end. Further, the system includes an inner telescoping member at least partially slidably disposed within the outer telescoping member and operably coupled to the outer telescoping member. Further, the system includes a thumb pad disposed and coupled at the proximal end of the inner telescoping member.

Description

Technical Field

[0001] The present disclosure generally relates to administration and / or infusion systems, devices, and processes for facilitating various levels of control over fluid delivery, and more particularly, to systems and methods related to administration and / or infusion systems for continuously delivering substances that can be administered or infused in multiple doses.

Background Art

[0002] Millions of syringes, such as those shown in Fig. 1A(2), are consumed daily in a medical environment. A typical syringe (2) includes a tubular body (4), a plunger (6), and a hypodermic needle (8). As shown in Fig. 1B, such a syringe (2) can be used not only to inject fluid into a patient, but also to draw fluid from or discharge fluid into containers such as vials, ampoules, bags, or other drug encapsulation systems (10). In fact, in some countries such as the United States, due to concerns about maintaining sterility and regulatory constraints, when a vial (10) is used with a syringe (2) as shown in a particular patient's environment, such a vial can only be used for a single patient and then must be disposed of, thereby resulting in a large amount of medical waste from the vials and the remaining drug waste, and also causing periodic shortages of certain important drugs. Referring to Fig. 2A, three Luer-type syringes (12) are shown, each having a Luer fitting shape (14) disposed on the distal side, and they are adapted to be coupled to other devices having a similar fitting shape, such as the Luer manifold assembly (16) shown in Fig. 2B. The Luer manifold assembly of Fig. 2B can be used to intravenously administer a liquid drug to a patient, regardless of the use of an intravenous infusion bag. The Luer fitting (14) of the syringe in Fig. 2A is sometimes referred to as a "male" Luer fitting, and the Luer fitting (18) of Fig. 2B is sometimes referred to as a "female" Luer fitting. One side of the Luer interface has threads formed thereon (in this case, its configuration is also referred to as a "Luer lock" configuration), and the two are coupled by relative rotation, and it may be combined with a compressive load in some cases. In other words, in one embodiment of the Luer lock, rotation is utilized, optionally together with compression, to engage the threads of the male fitting (14), which are configured to engage a flange on the female fitting (18) to place the device in a fluid-tight coupled state. In another embodiment, a tapered interface shape may be utilized to provide a Luer engagement using compression without using threads or rotation (such a configuration is also referred to as a "slip-on" or "cone" Luer configuration).Such luer connections are recognized as being relatively safe for operators, but there is a risk of the drug spilling, leaking, or the components breaking during the assembly of the luer connection. On the other hand, using a needle injection configuration poses a risk of the sharp needle contacting or piercing a person or an unwanted structure. For these reasons, so-called "safety syringes" have been developed.

[0003] An embodiment of a safety syringe (20) is shown in FIG. 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 the distal / extended configuration, such that the needle shield (22) can no longer return to the proximal / retracted position, thereby preventing accidental needle sticks after injection.

[0004] Another embodiment of a safety syringe (24) is shown in FIGS. 4A and 4B. In this configuration, after the plunger (6) is fully inserted into the syringe body (4), a retractable needle (26) is configured to be retracted (28, 26) to a safe position within the tubular body (4), as shown in FIG. 4B. Such a form configured to retract itself may be associated with problems of blood splashing / aerosolization, safe storage of pre-loaded energy that may malfunction and actuate too early, loss of accuracy in delivering a full dose injection due to residual dead space within the spring compression volume, and / or loss of retraction speed control that may be related to pain and patient discomfort.

[0005] The syringe market has become further complicated due to the increasing demand for prefilled syringe assemblies as shown in FIGS. 5A and 5B, which generally include 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-type interface (FIG. 5A shows the cap 35 in a fixed position, while FIG. 5B shows the cap removed to illustrate the luer-type interface 14). The liquid drug is within a volume or drug reservoir (40) between the distal seal and the distal end (37) of the plunger tip (36). The plunger tip (36) can include a standard butyl rubber material and is coated with a biocompatible lubricious coating (e.g., polytetrafluoroethylene (“PTFE”)) to facilitate favorable sealing and relative movement characteristics with respect to the associated syringe body structure and materials. The proximal end of the syringe body (34) in FIG. 5B includes a conventional integral 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 a full circumference or a portion of the circumference around the syringe body (34). A partial flange is known as a “clipped flange,” while the other flange is known as a “full flange.” The flange is used for gripping the syringe with the fingers and provides support for pushing the plunger to effect an injection. The syringe body (34) preferably includes a translucent material such as glass or a polymer. The plunger tip (36) can be disposed within the syringe body (34) to form a volume enclosed within the chamber or reservoir (40) and to assist in the discharge of the associated fluid through the needle. The syringe body (34) can be defined as generally cylindrical (i.e., such that a plunger tip 36 having a circular cross-sectional shape establishes a seal with respect to the syringe body (34)), or can be configured to have other cross-sectional shapes such as elliptical.

[0006] Such an assembly is desirable because it can be standardized and accurately mass-produced by a few manufacturers in the world who have the capacity to meet all of the constantly changing regulations regarding filling, packaging, and the selection of pharmaceutical / drug interfacing materials and the use of components. However, with such a simple configuration, generally, it cannot meet the new world standards regarding single-use, safety, automatic deactivation, and needle-stick prevention. For this reason, certain suppliers have moved towards more "vertical" solutions that attempt to meet all or at least some of the standards in one solution, such as those shown in FIG. 5C (41). As a result of attempting to meet those standards in many different scenarios, there are significant constraints on such products (including the constraints as described above with reference to FIGS. 3 - 4B), and the inventory and usage costs can be relatively high.

[0007] In the present application, the term "fluid" includes gels, jellies, creams, oils, ointments, emulsions, suspensions, dispersions, serums, semi-solids, semi-liquids, and / or liquids. These fluids can be either low-viscosity or high-viscosity. Some drugs are delivered continuously to multiple sites within or on the surface of a patient's body during a single treatment. In addition to systems for injecting drugs, other systems (i.e., administration systems) continuously administer drugs to multiple sites of a patient during the treatment process. The treatment process can involve a single administration or multiple administrations over time. There is a need for an administration and / or injection system that addresses the drawbacks of currently available configurations. In particular, there is a need for an administration and / or injection system that continuously administers and / or injects fluid to multiple sites of a single patient. Also, it is desirable that such a syringe assembly can utilize an existing relatively well-managed supply chain, such as pre-filled cartridges and other commercially available components that have been conventionally provided, and the corresponding assembly machinery and personnel. SUMMARY OF THE INVENTION

[0008] Embodiments are directed to an administration and / or infusion system. In particular, embodiments are directed to an administration and / or infusion system for continuously delivering a substance administrable or infusable in multiple doses.

[0009] In one embodiment, a fluid delivery system includes a syringe body having a proximal end and a distal end, an interior of the syringe, and a syringe flange provided at the proximal end. The system also includes a fluid disposed within the syringe interior. Further, the system includes a finger flange coupled to the syringe flange. Further, the system includes a stopper member disposed within the syringe interior. Further, the system includes a plunger member coupled to the stopper member and having a ratchet portion. The system also includes a push member coaxially disposed about at least a portion of the plunger member and operably coupled to the plunger member, the push member having an outer telescoping member disposed at its proximal end. Further, the system includes an inner telescoping member at least partially slidably disposed within the outer telescoping member and operably coupled to the outer telescoping member. Further, the system includes a thumb pad disposed at and coupled to the proximal end of the inner telescoping member.

[0010] In one or more embodiments, the finger flange includes a tubular member that projects in the proximal direction, and the distal end of the push member is disposed within the tubular member that projects in the proximal direction. The tubular member that projects in the proximal direction of the finger flange can define a surface facing the proximal direction. The outer telescoping member of the push member can define a distal-facing surface configured to interfere with the proximal-facing surface of the tubular member that projects in the proximal direction of the finger flange to limit the distal movement of the push member relative to the finger flange. The outer telescoping member of the push member can define a side opening having a proximal-facing wall. The inner telescoping member can define a distal-tapering member configured to interfere with the proximal-facing wall of the side opening of the outer telescoping member of the push member to limit the distal movement of the inner telescoping member relative to the outer telescoping member of the push member.

[0011] In one or more embodiments, the system also includes a distal spring disposed within a tubular member that protrudes in the proximal direction of the finger flange, the distal spring being disposed between the finger flange and the push member and contacting the finger flange and the push member. The system according to claim 5 can also include a proximal spring disposed within the outer telescoping member of the push member, the proximal spring being disposed between the push member and the inner telescoping member and contacting the push member and the inner telescoping member. The distal spring is weaker than the proximal spring and has a smaller preload in the stationary state. When a force in the distal direction is applied to the inner telescoping member via the thumb pad, first, the distal spring is compressed until the surface of the push member facing in the distal direction abuts against the surface of the tubular member protruding in the proximal direction of the finger flange, and then the proximal spring is compressed so that the inner telescoping member can move distally relative to the outer telescoping member. Also, the distal spring may be stronger than the proximal spring and have a larger preload in the stationary state. In that case, when a force in the distal direction is applied to the inner telescoping member via the thumb pad, first, the proximal spring is compressed until the tapered member of the inner telescoping member in the distal direction abuts against the wall of the outer telescoping member of the push member facing in the proximal direction, and then the distal spring is compressed so that the push member can move distally relative to the finger flange. Also, the distal spring and the proximal spring may have equal strength, whereby the push member and the inner telescoping member can move simultaneously. By having the distal spring and the proximal spring have the same strength, there is no noticeable difference in the movement of the push member, the inner telescoping member, and the thumb pad, and a smooth release force profile can be achieved.

[0012] In one or more embodiments, the push member includes a distal - extending claw that contacts and is operatively coupled to the ratchet portion of the plunger member. The ratchet portion of the plunger member can include a plurality of teeth. By fully depressing the thumb pad relative to the finger flange, the plunger member can advance distally relative to the syringe body by a distance of one tooth among the plurality of teeth.

[0013] The above - described embodiments and other embodiments of the present invention are described in the following detailed description.

Brief Description of the Drawings

[0014]

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[0015] To better understand the above and other advantages and objects of various embodiments, a more detailed description of the embodiments will be provided with reference to the accompanying drawings. Note that the drawings are not drawn to scale, and it should be noted that elements of similar structure or function are denoted by like reference numerals throughout. It should be understood that those drawings show only specific exemplary embodiments and thus should not be considered as limiting the scope of the embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0016] Exemplary multi-site administration and / or infusion system Many administrable or injectable agents can be administered to multiple administration, application, and / or injection sites on the same patient. Some medical procedures involve continuously administering, applying, and / or injecting a certain amount (e.g., a volume in units of 0.1 ml and / or microliters) of an agent (e.g., botulinum toxin or "Botox") at multiple administration, application, and / or injection sites on a patient. Currently, many agents are drawn from vials into the administration and / or injection system, which increases the treatment time and the chance of being exposed to an unexpected puncture by a needle. Further, since some agents are administered as viscous solutions, a needle with a larger diameter (e.g., a low gauge: 25g) is required to draw the viscous agent into the administration and / or injection system, and a needle with a smaller diameter (e.g., a high gauge: 30g, 32g, 34g, less than 34g) is required for injection. This needle exchange increases the treatment time and the risk of an unintentional puncture. The multi-site administration and / or injection system described herein addresses these problems of current systems.

[0017] Figures 6-15 illustrate a multi-site administration and / or injection system 600 according to some embodiments. As shown in Figure 6, the system 600 can be pre-filled with an administrable or injectable agent. The system 600 includes a syringe body 610, a stopper member 620, a plunger member 630, and a finger flange 640. The syringe body 610 includes a syringe flange 612 to which the finger flange 640 is coupled at its proximal end. Also, the syringe body 610 includes a needle hub coupling member 614 (e.g., a female Luer connector) configured to removably couple a needle hub (not shown), another administration mechanism (not shown), or an applicator tip (see Figures 16-20) that includes a needle (not shown).

[0018] Many of these system components (e.g., syringe body 610 and stopper member 620, and needle hub (not shown)) are commercially available components, and existing relatively well - managed supply chains, as well as corresponding assembly machinery and personnel, can be utilized. The syringe body 610 may be made of glass, metal, or a polymer material, such as COC, COP, polypropylene, polyethylene, or other syringe materials. The stopper member 620 may be made of rubber such as butyl, chlorobutyl, bromobutyl, or a polymer material such as a thermoplastic elastomer. The stopper member 620 may be covered with a protective and / or lubricating coating such as PTFE or other polymers. The off - the - shelf stopper member 620 refers to a commercially available stopper member that does not include protrusions or recesses for coupling to the needle and has an overall smooth distal - facing surface.

[0019] Also, system 600 also includes a push member 650 configured to apply a distal - directed force to the plunger member 630 and the stopper member 620 coupled thereto. In FIG. 6, the stopper member 620 and the plunger member 630 are shown separately for clarity. The distal end of the plunger member 630 includes a distal spike 633 configured to engage within the stopper member 620. The distal spike 633 of the plunger member 630 includes a shaft 634 and a head 635 configured to resist withdrawal of the plunger member 630 from the stopper member 620. In an alternative embodiment, the distal end of the plunger member 630 can include a threaded connection (not shown) with the stopper member 620, or can be flat (not shown) and rest on the stopper member 620. The push member 650 includes an outer telescoping member 660 at its proximal end. Further, system 600 includes an inner telescoping member 670 disposed at least partially slidably within the outer telescoping member 660. Further, system 600 includes a thumb pad 680 coupled to the proximal end of the inner telescoping member 670.

[0020] The finger flange 640 includes a tubular member 642 that protrudes in the proximal direction. The distal end of the push member 650 is slidably disposed within the tubular member 642 that protrudes in the proximal direction. Similarly, the distal end of the inner telescoping member 670 is slidably disposed within the outer telescoping member 660 defined by the push member 650.

[0021] FIG. 7 is a detailed longitudinal cross-sectional view of the multi-site administration and / or injection system 600 shown in FIG. 6. As shown in FIG. 7, the tubular member 642 that protrudes in the proximal direction of the finger flange 640 defines a surface 644 that faces in the proximal direction. The outer telescoping member 660 of the push member 650 defines a distal-facing surface 662 configured to interfere with the proximal-facing surface 644 of the tubular member 642 that protrudes in the proximal direction of the finger flange 640, thereby restricting the distal movement of the push member 650 relative to the finger flange 640. For this reason, the push member 650 can move distally relative to the finger flange 640 by a distance defined by the distance between the proximal-facing surface 644 of the tubular member 642 that protrudes in the proximal direction of the finger flange 640 and the distal-facing surface 662 of the outer telescoping member 660 of the push member 650.

[0022] As also shown in FIG. 7, the outer telescoping member 660 of the push member 650 defines a side opening 664 having a proximal-facing wall 666. The inner telescoping member 670 defines a distally tapering member 672 configured to interfere with the proximal-facing wall 666 of the side opening 664 of the outer telescoping member 660 of the push member 650, thereby restricting the distal movement of the inner telescoping member 670 relative to the outer telescoping member 660 of the push member 650. For this reason, the inner telescoping member 670 can expand and contract distally into the outer telescoping member 660 by a distance defined by the distance between the proximal-facing wall 666 of the side opening 664 of the outer telescoping member 660 of the push member 650 and the distally tapering member 670 of the inner telescoping member 670.

[0023] System 600 also includes a distal spring 690 disposed within a tubular member 642 that protrudes in the proximal direction of the finger flange 640. This distal spring is disposed between and in contact with the finger flange 640 and the push member 650. The distal spring 690 biases the push member 650 in the distal direction to move it away from the finger flange 640. Further, system 600 also includes a proximal spring 695 disposed within an outer telescoping member 660 defined by the push member 650. This proximal spring is disposed between and in contact with the push member 650 and the inner telescoping member 670. The proximal spring 695 biases the inner telescoping member 670 in the proximal direction to move it away from the outer telescoping member 660 and the push member 650. In an embodiment where the distal spring 690 is weaker than the proximal spring 695, when a force directed in the distal direction is applied to the inner telescoping member 670 via the thumb pad 690, that force is transmitted to the push member 650 via the proximal spring 695. This transmitted force moves the push member 650 in the distal direction relative to the finger flange 640, compressing the distal spring 690 until the distal-facing surface 662 of the outer telescoping member 660 of the push member 650 abuts against the proximal-facing surface 644 of the tubular member 642 that protrudes in the proximal direction of the finger flange 640, thereby preventing further distal movement of the push member 650 relative to the finger flange 640. Continuing to apply a force directed in the distal direction compresses the proximal spring 695, enabling the inner telescoping member 670 to telescopically move distally within the outer telescoping member 660.

[0024] FIG. 8 is a detailed longitudinal cross-sectional view of the multi-site administration and / or injection system 600 shown in FIGS. 6 and 7 along a plane orthogonal to the cross-section of FIG. 7. As shown in FIG. 8, the proximal end of the push member 650 defines a pair of distally extending claws 652 that are operably coupled in contact with the ratchet portion 632 of the plunger member 630. The claws 652 can be formed of metal or polymer. The ratchet portion 632 of the plunger member 630 includes a plurality of teeth 634 that taper distally. Thus, when the push member 650 moves distally, the pair of distally extending claws 652 presses the respective teeth 634 and the plunger member 630 attached thereto distally. When the push member 650 returns proximally by the distal spring 690, the pair of distally extending claws 652 can straddle the respective teeth 634 and move one set of teeth 634 proximally. By advancing the plunger member 630, a preset dose of the administrable and / or injectable fluid is discharged from the syringe body 610. Then, the pair of distally extending claws 652 is returned to a proximal position adjacent to the next pair of teeth 634 in the proximal direction, and the system 600 is prepared to continuously discharge the next dose of the administrable and / or injectable fluid.

[0025] FIGS. 9-15 illustrate an exemplary method of operating the multi-site administration and / or injection system 600 to prepare the system 600 to continuously discharge the next dose of the administrable and / or injectable fluid while advancing the plunger member 630 to discharge a preset dose of the administrable and / or injectable fluid from the syringe body 610. In the administration and / or injection system 600 shown in FIGS. 9-15, the distal spring 690 is weaker than the proximal spring 695. In other embodiments, the springs 690, 69...

[0026] FIG. 9 is a detailed longitudinal sectional view of the multi-site administration and / or injection system 600 shown in FIGS. 6-8, along the same cross-section as FIG. 8, after the system 600 has completed delivery of three preset doses of injectable and / or infusible fluid from the syringe body 610 and is ready to deliver the fourth dose of injectable and / or infusible fluid. To that end, the pair of distally-directed claws 652 are disposed immediately proximal to the pair of third teeth 634-3. FIG. 14 is an even more detailed longitudinal sectional view of the system 600 showing the relative positions of the pair of distally-directed claws 652 and the pair of third teeth 634-3. Here, the push member 650 has been moved distally by the distal spring 690, and since the system 600 is ready to deliver the next dose, the gap between the proximally-facing surface 644 of the tubular member 642 that projects proximally from the finger flange 640 and the distally-facing surface 662 of the outer telescoping member 660 of the push member 650 has increased.

[0027] FIG. 10 is a detailed longitudinal sectional view of the multi-site administration and / or injection system 600 shown in FIGS. 6-9, along the same cross-section as FIG. 8, after a distally-directed force has been applied to the push member 650 (via the thumb pad 680, the inner telescoping member 670, and the proximal spring 695 (see FIG. 7)). The distally-directed force moves the push member 650 and the outer telescoping member 660 that forms part thereof distally. This eliminates the gap between the proximally-facing surface 644 of the tubular member 642 that projects proximally from the finger flange 640 and the distally-facing surface 662 of the outer telescoping member 660 of the push member 650. Further, this causes the pair of distally-directed claws 652 to press the pair of third teeth 634-3 and the plunger member 630 attached thereto distally by a distance equal to the gap between the proximally-facing surface 644 of the tubular member 642 that projects proximally from the finger flange 640 and the distally-facing surface 662 of the outer telescoping member 660 of the push member 650. This gap is slightly larger than the distance between the two teeth 634 on the ratchet portion 632 of the push member 630, providing a tolerance for the machining of those small components.

[0028] Figure 11 is a detailed longitudinal sectional view along the same cross-section as FIGS. 6 and 7 (orthogonal to the cross-sections of FIGS. 8 - 10) of the multi-site administration and / or injection system 600 shown in FIGS. 6 - 10, which has the same configuration as that shown in FIG. 10. There is no gap between the proximally facing surface 644 of the tubular member 642 protruding in the proximal direction of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the push member 650, and further distal movement of the push member 650 relative to the finger flange 640 is prevented. However, there still exists a second gap between the distally tapering member 672 of the inner telescopic member 670 and the wall 666 facing proximally of the side opening 664 of the outer telescopic member 660 of the push member 650. This second gap allows the outer telescopic member 660 of the push member 650 to expand and contract distally therein, thereby compressing the proximal spring 695. The relative spring forces of the distal spring 690 and the proximal spring 695 are adjusted such that a typical user cannot distinguish between compressing the distal spring 690 (and delivering a dose of the administrable and / or injectable fluid) and compressing the proximal spring 695 (and expanding and contracting the inner and outer telescopic members 670, 660 together).

[0029] Figure 12 is a detailed longitudinal sectional view along the same cross-section as FIG. 11 of the multi-site administration and / or injection system 600 shown in FIGS. 6 - 11 after the second gap between the distally tapering member 672 of the inner telescopic member 670 and the wall 666 facing proximally of the side opening 664 of the outer telescopic member 660 of the push member 650 has disappeared due to a force in the further distal direction and the expansion and contraction of the inner and outer telescopic members 670, 660. The expansion and contraction of the inner and outer telescopic members 670, 660 together results in a longer stroke compared to the length of one tooth 634, improving the tactile feedback to the user.

[0030] FIG. 13 is a detailed longitudinal cross-sectional view along the same cross-section as FIG. 8 (orthogonal to the cross-sections of FIGS. 11 and 12) of the multi-site administration and / or injection system 600 shown in FIGS. 6-12 after a force directed distally has been removed from the system 600 and the distal spring 690 and proximal spring 695 have returned the push member 650 and the inner telescoping member 672 to their respective proximal positions, and FIG. 15 is a further detailed longitudinal cross-sectional view thereof. By returning the push member 650 to its proximal position, the pair of claws 652 extending distally move to a proximal position adjacent to the next pair of teeth 634 (i.e., the pair of the fourth teeth 634-4) in the proximal direction. By resetting the push member 650 and the inner telescoping member 672 to their respective proximal positions, the system 600 is ready to continuously discharge the next dose of the administrable and / or injectable fluid.

[0031] In the embodiments shown in FIGS. 9-15, the distal spring 690 is weaker than the proximal spring 695, but in other embodiments, the distal spring 690 is stronger than the proximal spring 695. In such embodiments, when a force directed distally is applied to the inner telescoping member 670 via the thumb pad 690, first, the proximal spring 695 is compressed, whereby the inner telescoping member 670 contracts within the outer telescoping member 660. The distal spring 690 is compressed until the tapered member 672 of the inner telescoping member 670 in the distal direction abuts and interferes with the wall 666 facing proximally of the side opening 664 of the outer telescoping member 660 of the push member 650, and only then is the force directed distally transmitted through the inner telescoping member 670 and the push member 650 moves distally. By continuously applying a force directed distally, the push member 650 moves distally relative to the finger flange 640 and a dose of the administrable and / or injectable fluid is delivered. Thereby, the distal spring 690 is compressed until the distal-facing surface 662 of the outer telescoping member 660 of the push member 650 abuts the proximal-facing surface 644 of the tubular member 642 protruding proximally of the finger flange 640, preventing further distal movement of the push member 650 relative to the finger flange 640 and reaching the end of the stroke.

[0032] In other embodiments, the distal and proximal springs 690, 695 have the same strength, there is no significant difference in the movement of the push member 650, the inner telescoping member 670, and the thumb pad 680, and a smooth release force profile can be achieved. In some embodiments, it is described that one spring (e.g., the weaker spring) is compressed before the other spring (e.g., the stronger spring) is compressed. However, in other embodiments, both the distal spring 690 and the proximal spring 695 are compressed / expanded simultaneously. The distal spring 690 and the proximal spring 695 can be compressed / expanded at different speeds depending on their respective strengths. In some embodiments, after the gap between the surface 662 facing the distal direction of the outer telescoping member 660 of the push member 650 and the surface 644 facing the proximal direction of the tubular member 642 protruding in the proximal direction of the finger flange 640 is closed, the inner telescoping member 670 continues to move a relatively large distance, thereby improving user feedback. The relative strength of each spring 690, 695 can be adjusted to provide the desired force profile. Springs 690, 695 are shown as coil springs that are loaded in the compressed state, but in various embodiments, alternative springs such as extension springs and / or leaf springs can also be used.

[0033] Applicator tip and cap Figures 16 and 17 are perspective and side views of a multi-site administration system 700 comprising an applicator tip (see Figures 19 and 20) and a cap 800 according to some embodiments. The multi-site administration system 700 shown in Figures 16 - 20 is substantially the same as the multi-site administration and / or injection system 600 shown in Figures 6 - 15. For example, the multi-site administration system 700 includes a syringe body 710, a stopper member 720, a plunger member 730, and a finger flange 740. The syringe body 710 includes a syringe flange 712 at its proximal end, on which the finger flange 740 is coupled. The syringe body 710 also includes a needle hub coupling member 714. The only difference between the two systems 600, 700 is that the system 700 includes an applicator tip (see Figures 19 and 20) and a cap 800. Aspects of the multi-site administration system 700 that are similar to aspects of the multi-site administration and / or injection system 600 have corresponding reference numerals that differ only in the first digit and have functions similar to those of the aspects of the system 600 described above.

[0034] The multi-site administration system 700 includes a syringe body 710 and a finger flange 740 coupled thereto. The syringe body 710 includes a syringe flange 712 at its proximal end, on which the finger flange 740 is coupled. The syringe body 710 also further includes a coupling member 714 (e.g., a female Luer connector) and an applicator tip (see Figures 19 and 20) coupled thereto. The cap 800 is removably coupled to the applicator tip.

[0035] The finger flange 740 includes a tubular member 742 that protrudes in the proximal direction. The system 700 also includes an outer telescoping member 760 formed at the proximal end of a push member (not shown). Further, the system 700 also includes an inner telescoping member 770 that is at least partially slidably disposed within the outer telescoping member 760. The thumb pad 780 is coupled to the proximal end of the inner telescoping member 770. As shown in FIGS. 19 and 20, the applicator tip / nozzle 900 is coupled to a coupling member 714 (female luer connector) formed at the distal end of the syringe body 710, for example, by a male luer connector. On the other hand, the cap 800 is removably attached to the applicator tip 900. In embodiments that include a connector (e.g., a luer), the user can attach the applicator tip 900 to the syringe body 710 immediately prior to administration. In other embodiments, the applicator tip 900 is welded to the syringe body 710 during manufacture. The applicator tip 900 is configured to administer a substance (e.g., a liquid or a gel) from the syringe body 710 multiple times.

[0036] The cap 800 can include a rigid polymer shell 810 and an elastic inner member 820 that forms a seal around the inner surface of the cap 800. When the user is ready for administration, the cap 800 can be pulled out to depress the thumb pad 780. When administration is complete, the user can reattach the cap 800, thereby preventing contamination and / or accidental administration.

[0037] FIG. 18 is a detailed perspective view of a multi-site administration system with an applicator tip and a cap according to some embodiments. FIG. 19 is a detailed exploded perspective view of a multi-site administration system with an applicator tip and a cap according to some embodiments. FIG. 20 is a detailed longitudinal cross-sectional view of a multi-site administration system with an applicator tip and a cap according to some embodiments.

[0038] As shown in FIG. 20, between the applicator tip 900 and the luer cone 716 of the coupling member 714 of the syringe body 710, there is an elastic seal 910 that is lightly compressed during assembly. The seal 910 prevents fluid from leaking within the threaded region of the coupling member 714 of the syringe body 710, without relying on a compression fit between the concentric cone of the coupling member 714 of the syringe body 710 and the cap 800. The applicator tip 900 defines a concave ring 920, which facilitates the removable coupling of the cap 800 when the elastic inner member 820 expands within the concave ring 920. The applicator tip 900 can facilitate the control of the diameter of the cylinder of the thick fluid (drug) to be extruded and increase the extrusion length. The applicator tip 900 also includes a connector 930 (e.g., male luer cone) disposed in the gap between the luer cone 716 and the threaded collar 718 of the syringe body 710, thereby minimizing the loss of the fluid / drug disposed therein through this gap.

[0039] Multi-site infusion system FIG. 21 is a detailed exploded perspective view of a multi-site injection system 1000 including a needle hub 1100 and a cap 800 according to some embodiments. FIG. 22 is a detailed longitudinal cross-sectional view of a multi-site injection system 1000 including a needle hub 1100 and a cap 800 according to some embodiments.

[0040] The multi-site injection system 1000 shown in FIGS. 21 and 22 is substantially the same as the multi-site administration and / or injection system 600 shown in FIGS. 6 - 15 and the multi-site administration system 700 shown in FIGS. 16 - 20. The only difference among those systems 600, 700, 1000 is that the system 1000 includes a needle hub 1100. The aspects of the multi-site injection system 1000 that are similar to the aspects of the multi-site administration and / or injection systems 600, 700 have corresponding reference numerals that differ only in the first digit and have functions similar to those of the aspects of the system 600 described above. The needle hub 1100 includes a needle 1110 configured to inject a substance (e.g., a liquid or a gel) from a syringe body 710 into a patient multiple times.

[0041] The administration and / or injection systems described and illustrated herein include syringes having luer connectors, but the multi-site administration and / or injection systems described herein can also be used with fixed needles, cartridges, auto-injectors, etc. The multi-site administration and / or injection systems described herein can also be used with safety administration and / or injection systems.

[0042] Various exemplary embodiments of the present invention are described herein. These examples are referred to in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the present invention. Various changes can be made to the described invention and equivalents can be substituted without departing from the true spirit and scope of the present invention. Further, many changes can be made to adapt a particular situation, material, composition of matter, process, process operation or step to the objectives, spirit or scope of the present invention. Further, as will be understood by those skilled in the art, each of the individual variations described and illustrated herein can be readily separated from or combined with the features of any of several other embodiments without departing from the scope or spirit of the present invention. All such changes are intended to be within the scope of the claims related to this disclosure.

[0043] Any of the devices described for performing the diagnostic or intervention procedure of interest may be provided in a packaged combination for use in performing such an intervention. Those supply "kits" may further include instructions for use and may be packaged in a sterile tray or container such as is commonly employed for such purposes.

[0044] The present invention includes a method of performing using a device of interest. The method can include the act of providing such a suitable device. Such providing may be performed by an end user. That is, the act of "providing" simply requires the end user to perform an act of obtaining, accessing, approaching, positioning, setting up, activating, powering on or other act to provide the necessary device in the method of interest. The methods described herein can perform the described events in any logically possible order or in the order of the described events.

[0045] Exemplary aspects of the present invention have been described above, along with details regarding material selection and manufacture. Regarding other details of the present invention, they can be understood not only in relation to the previously cited patents and publications, but are also generally known or understandable to those of ordinary skill in the art. For example, one of ordinary skill in the art would understand that one or more lubricious coatings (such as hydrophilic polymers like polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels or silicones) can be used in connection with various parts of the device, such as relatively large interfacial surfaces of movably coupled parts, as needed, thereby facilitating, for example, low-friction operation or advancement of such objects relative to other parts of the instrument or nearby tissue structures. The same would apply to aspects based on the methods of the present invention regarding additional acts generally or logically employed.

[0046] Furthermore, although the present invention has been described with reference to some examples incorporating various features arbitrarily, the present invention is not limited to what has been described or disclosed as contemplated for each variation of the present invention. Various changes can be made to the described invention without departing from the true spirit and scope of the present invention, and can be replaced with equivalents (whether described herein or not included for brevity). Further, when a range of values is provided, it is to be understood that all intervening values between the upper and lower limits of that range, as well as other described or intervening values within the described range, are included within the scope of the present invention.

[0047] Also, any feature of the described variations of the present invention is contemplated to be described and claimed independently or in combination with any one or more of the features described herein. References to singular items include the possibility that there are multiple occurrences of the same item. More specifically, as used in this specification and the appended claims, the singular forms "a", "an", "said", and "the" include plural referents unless otherwise specified. In other words, the use of the article enables "at least one" of the subject items in the above description, as in the appended claims accompanying this disclosure. Note that such claims may be drafted to exclude optional elements. For this reason, this description is intended to function as a prior description using exclusive terms such as "alone", "only", etc. in relation to the listing of claim elements, or as a prior description for using "negative" limitations.

[0048] Without using such exclusive terms, the term "comprising" in the claims accompanying the present disclosure shall be taken to allow any additional elements, whether or not a given number of elements are recited in such claims or whether or not the addition of a feature is regarded as changing the nature of the elements recited in such claims. Unless specifically defined herein, all technical and scientific terms used herein shall be given the broadest and generally understood meaning possible while maintaining the validity of the claims.

[0049] The scope of the present invention is not limited to the provided examples and / or the specification of the subject matter, but rather is limited only by the scope of the language of the claims accompanying the present disclosure.

Claims

1. A fluid delivery 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 fluid placed inside the syringe, The finger flange to which the syringe flange is coupled, The stopper member is placed inside the syringe, A plunger member having a ratchet portion is coupled to the stopper member, A push member is coaxially arranged around at least a portion of the plunger member and operably coupled with the plunger member, wherein the push member has an outer telescopic member positioned at its proximal end, An inner telescope member is disposed at least partially slidably within the outer telescope member and is operably coupled with the outer telescope member, The inner telescope member comprises a thumb pad positioned and coupled to the proximal end of the inner telescope member, The finger flange includes a tubular member that protrudes in the proximal direction, The distal end of the push member is positioned within the tubular member that protrudes in the proximal direction. The tubular member protruding proximally from the finger flange defines a surface facing the proximal direction, The system is characterized in that the outer telescopic member of the push member defines a distal surface configured to interfere with the proximal surface of a tubular member protruding proximal to the finger flange, in order to restrict the distal movement of the push member relative to the finger flange.

2. In the system described in claim 1, The outer telescopic member of the push member defines a side opening having a wall facing the proximal direction, The system is characterized in that the inner telescope member includes a distally tapering member configured to interfere with the proximal-facing wall of the side opening of the outer telescope member of the push member, in order to restrict the distal movement of the inner telescope member relative to the outer telescope member of the push member.

3. In the system described in claim 2, A distal spring disposed within a tubular member protruding proximal to the finger flange, further comprising a distal spring disposed between the finger flange and the push member, and in contact with the finger flange and the push member.

4. In the system described in claim 3, A system characterized by further comprising a proximal spring disposed within the outer telescopic member of the push member, the proximal spring being disposed between the push member and the inner telescopic member and in contact with the push member and the inner telescopic member.

5. In the system described in claim 4, The distal spring is weaker than the proximal spring, and has a smaller preload in a stationary state. When a distal force is applied to the inner telescope member via the thumb pad, the distal spring is first compressed until the distal surface of the push member contacts the proximal surface of the tubular member protruding proximal to the finger flange. Subsequently, the proximal spring is compressed, allowing the inner telescope member to move distally relative to the outer telescope member.

6. In the system described in claim 4, The distal spring is stronger than the proximal spring, and has a greater preload in a stationary state. When a distal force is applied to the inner telescope member via the thumb pad, the proximal spring is first compressed until the distally tapering portion of the inner telescope member contacts the proximal wall of the outer telescope member of the push member. Subsequently, the distal spring is compressed, allowing the push member to move distally relative to the finger flange.

7. In the system described in claim 4, A system characterized in that the strength of the distal spring and the proximal spring are equal, thereby causing the push member and the inner telescope member to move simultaneously.

8. In the system described in claim 1, The system is characterized in that the push member has a distally extending claw that contacts the ratchet portion of the plunger member and is operably coupled with the ratchet portion.

9. In the system described in claim 8, The system is characterized in that the ratchet portion of the plunger member has multiple teeth.

10. In the system described in claim 9, The system is characterized in that by completely pressing the thumb pad down relative to the finger flange, the plunger member advances distally relative to the syringe body by the distance of one of the multiple teeth.

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