Systems and methods for multi-site dispensing or injection

Abstract

A fluid delivery system includes a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end thereof. The system also includes a finger flange coupled to the syringe flange. In addition, the system includes a stop member disposed inside the syringe. Further, the system includes a plunger member coupled to the stop member and having a ratchet portion. The system also includes an urging member disposed coaxially about and operably coupled to at least a portion of the plunger member, the urging member having an outer telescoping member disposed at a proximal end thereof. The system also includes an inner telescoping member slidably and at least partially disposed in the outer telescoping member and operably coupled to the outer telescoping member. Further, the system includes a thumb pad configured to be coupled to the proximal end of the inner telescoping member.

Description

Technical Field

[0001] The present invention generally relates to dispensing and / or injection systems, devices and processes for providing varying degrees of control over fluid delivery, and more particularly to systems and methods for dispensing and / or injection systems for continuously delivering multiple doses of dispensable or injectable substances. Background Art

[0002] Millions of syringes are consumed every day in healthcare settings, e.g. Figure 1A (2) as shown. A typical syringe (2) includes a tubular body (4), a plunger (6) and an injection needle (8). Figure 1B As shown, such a syringe (2) can be used not only to inject fluid into a patient's body, but also to extract or discharge fluid from a container such as a medicine bottle, a medicine vial, a bag, or other drug containing system (10). In fact, due to regulatory restrictions in some countries such as the United States and considerations of aseptic maintenance, when a medicine bottle (10) with a syringe (2) is used in a patient-specific environment, such a medicine bottle can only be used for a single patient and must then be disposed of - resulting in a large amount of medical waste in the disposal of medicine bottles and remaining medicines, and even causing periodic shortages of certain key drugs. Reference Figure 2A , showing three Luer-type syringes (12), each having a distally disposed Luer fitting geometry (14) so ​​that they can be coupled with other devices having similar mating geometry, e.g. Figure 2B The Luer multi-tip catheter assembly (16) shown. With or without an IV bag, Figure 2B The Luer Multi-Tip Catheter Assemblies can be used to administer liquid medications intravenously to patients. Figure 2A The Luer connector (14) of the syringe can be called a "male" Luer connector, while Figure 2B(18) may be referred to as a "female" Luer connector; one of the Luer interfaces may be threaded (in which case the configuration may be referred to as a "Luer lock" configuration) so that the two sides may be connected by relative rotation, which may be combined with a compressive load. In other words, in one Luer lock embodiment, rotation (possibly accompanied by compression) may be used to engage threads within the male connector (14), which threads are configured to engage flanges on the female connector (18) and bring the devices together into a fluid-tight connection. In another embodiment, a tapered interface geometry may be used to provide Luer engagement by compression without threads or rotation (such a configuration may be referred to as a "slip-on" or "conical" Luer configuration). Although such Luer connections are considered relatively safe for the operator, there is a risk of drug spillage / leakage and part breakage during assembly of the Luer connection. On the other hand, the use of a needle injection configuration carries the risk of the sharp needle contacting or stabbing an unwanted person or structure. For this reason, so-called "safety syringes" have been developed.

[0003] Figure 3 An embodiment of a safety syringe (20) is shown in which a tubular shield member (22) is spring biased to cover the needle (8) when released from a proximal / retracted position relative to the syringe body (4). The tubular needle shield (22) is "locked" in the distal / extended configuration so that the needle shield (22) can no longer return to the proximal / retracted position to prevent accidental needle sticks after injection.

[0004] Figure 4A-4B Another embodiment of a safety syringe (24) is shown. With this configuration, after the plunger (6) is fully inserted relative to the syringe body (4), the retractable needle (26) is configured to retract (28, 26) to a safe position within the tubular body (4), such as Figure 4B Such a configuration, which is configured to collapse on itself, may be associated with problems such as blood splatter / aerosolization issues, safe storage of preload energy which may fail and activate before desired, loss of accuracy in administering a full dose injection due to residual dead space within the spring compression volume, and / or loss of control over retraction speed which may be associated with pain and patient anxiety.

[0005] Further complicating the syringe market is the increasing demand for prefilled syringe components, e.g. Figure 5A and Figure 5B As shown, it generally includes a syringe body or a "drug packaging delivery system / drug closure container delivery system" (34), a plunger head, a plug or a stopper (36), and a distal seal or cover cap (35) that can be mounted on a Luer-type interface ( Figure 5A The cap 35 is shown in position; Figure 5BThe cap is removed to show the Luer interface 14). Liquid drug may be present in a volume or drug reservoir (40) between the distal seal and the distal end (37) of the plunger tip (36). The plunger tip (36) may comprise a standard butyl rubber material and may be coated with, for example, a biocompatible lubricious coating (e.g., polytetrafluoroethylene ("PTFE")) to facilitate preferred sealing and relative movement characteristics with respect to the associated syringe body structure and materials. Figure 5B The proximal end of the syringe body (34) in the embodiment includes a conventional one-piece syringe flange (38) which is integrally formed with the material of the syringe body (34). The flange (38) is configured to extend radially from the syringe body (34) and can be configured to surround the entire circumference or a portion of the circumference of the syringe body (34). A portion of the flange is referred to as a "truncated flange" and another portion is referred to as a "full flange". The flange is used to grasp the syringe with the fingers to provide support for pushing the plunger for injection. The syringe body (34) preferably includes a translucent material, such as glass or a polymer. In order to form a closed volume within the chamber or reservoir (40) and to facilitate the discharge of the associated fluid through the needle, a plunger head (36) can be disposed within the syringe body (34). The syringe body (34) can define a substantially cylindrical shape (i.e., such that the plunger head 36 having a circular cross-sectional shape can be sealed relative to the syringe body (34)), or can be configured to have other cross-sectional shapes, such as an elliptical shape.

[0006] Such components are ideal because they can be standardized and precisely mass-produced by a small number of manufacturers around the world who are able to meet all of the world’s ever-changing regulations regarding fill, packaging and drug / drug interface material selection and component / component use. However, such simple configurations often do not meet new world standards for single-use, safety, automatic deactivation and needle-stick resistance. As a result, some suppliers have turned to more “vertical” solutions, such as Figure 5C (41) in which the solution attempts to meet all or at least some of the criteria with one solution; due to the attempt to meet these criteria in many different situations, these products may have significant limitations (including those referenced above). Figure 3-4B some limitations described in ) and relatively high storage and usage costs.

[0007] The term "fluid" used in this application includes gels, jelly / jelly, creams, oils, ointments, emulsions, suspensions, dispersions, serums, semisolids, semiliquids and / or liquids. These fluids may have low viscosity or high viscosity. Some drugs are continuously delivered to multiple parts of the patient's body or body surface in a single treatment. In addition to the system for injecting drugs, other systems (i.e., distribution systems) continuously distribute drugs to multiple parts of the patient during the treatment process. The treatment process can be a single administration or multiple administrations at intervals of a period of time. A distribution and / or injection system is needed to address the shortcomings of the currently available configurations. In particular, a distribution and / or injection system that continuously distributes and / or injects fluids at multiple parts of a patient is needed. It is also hoped that this syringe assembly can utilize an existing and relatively well-controlled supply chain, which is composed of prefilled cartridges and other readily available components of traditional delivery and corresponding assembly machines and personnel. Summary of the invention

[0008] Various embodiments relate to a dispensing and / or injection system. In particular, these embodiments relate to a dispensing and / or injection system for continuously delivering multiple doses of a dispensable or injectable substance.

[0009] In one embodiment, a fluid delivery system includes a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange located at its proximal end. The system also includes a fluid disposed in the syringe interior. The system also includes a finger flange / finger-shaped flange coupled to the syringe flange. In addition, the system includes a stop member disposed in the syringe interior. In addition, the system includes a plunger member, which is coupled to the stop member and has a ratchet portion. The system also includes a push member coaxially disposed around at least a portion of the plunger member and operably coupled thereto, the push member having an outer telescopic member disposed at its proximal end. The system also includes an inner telescopic member, which is slidably and at least partially disposed in the outer telescopic member and operably coupled to the outer telescopic member. In addition, the system includes a thumb pad coupled to the proximal end of the inner telescopic member.

[0010] In one or more embodiments, the finger flange includes a proximally protruding tubular member, and the distal end of the push member is disposed in the proximally protruding tubular member. The proximally protruding tubular member of the finger flange may define a proximally facing surface. The outer telescopic member of the push member may define a distally facing surface, which is configured to interfere with the proximally facing surface of the proximally protruding tubular member of the finger flange to limit the distal movement of the push member relative to the finger flange. The outer telescopic member of the push member may define a side opening having a proximally facing wall. The inner telescopic member may define a distally tapered member, which is configured to interfere with the proximally facing wall of the side opening of the outer telescopic member of the push member to limit the distal movement of the inner telescopic member relative to the outer telescopic member of the push member.

[0011] In one or more embodiments, the system further comprises a distal spring disposed in the proximally projecting tubular member of the finger flange, between and in contact with the finger flange and the push member. The system of claim 5 may include a proximal spring disposed in the outer telescopic member of the push member, between and in contact with the push member and the inner telescopic member. The distal spring may be weaker / less powerful than the proximal spring, having a smaller preload in a static state, such that applying a distally directed force to the inner telescopic member by the thumb pad initially compresses the distal spring until a distally facing surface of the push member abuts a proximally facing surface of the proximally projecting tubular member of the finger flange before compressing the proximal spring to allow the inner telescopic member to move distally relative to the outer telescopic member. The distal spring may be stronger than the proximal spring, with a greater preload at rest, so that applying a distally directed force to the inner telescopic member through the thumb pad initially compresses the proximal spring until the distally tapered member of the inner telescopic member abuts the proximally facing wall of the outer telescopic member of the push member before compressing the distal spring to allow the push member to move distally relative to the finger flange. The distal spring and the proximal spring may have equal strengths so that the push member and the inner telescopic member move simultaneously. Distal and proximal springs having the same strength allow for a smooth expulsion / pullout force profile with no perceptible difference between the motion of the inner telescopic member and the thumb pad and the push member.

[0012] In one or more embodiments, the push member includes a distally extending pawl that contacts and operably couples with a ratchet portion of the plunger member. The ratchet portion of the plunger member may include a plurality of teeth. Sufficient depression of the thumb pad relative to the finger flange may cause the plunger member to be advanced distally relative to the syringe body by a distance of one of the plurality of teeth.

[0013] These and other embodiments of the present invention are described in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figures 1A to 5C Various aspects of a conventional syringe configuration are shown.

[0015] Figure 6 is a longitudinal cross-sectional view of a multi-site dispensing and / or injection system according to some embodiments.

[0016] Figure 7 yes Figure 6 A detailed longitudinal cross-sectional view of a multi-site dispensing and / or injection system is shown.

[0017] Figure 8 yes Figure 6 and 7 A detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system shown, the cross-sectional view being taken along the Figure 7 The section is cut in a plane orthogonal to the section.

[0018] Fig. 9 and Fig.14 is along with Figure 8 A more detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system taken through the same section plane, ready to deliver a fourth dose of a dispensable or dispensable or injectable fluid.

[0019] Fig.10 is after a fourth dose of the dispensable or injectable fluid has been delivered, Fig. 9 The multi-site dispensing and / or injection system shown is along with Figure 8 Detailed longitudinal section taken from the same section.

[0020] Fig.11 yes Fig. 9 The multi-site dispensing and / or injection system shown is along with Figure 7 The same section (with Figure 8 A detailed longitudinal sectional view taken orthogonally to the section in FIG. Fig.10 Same configuration as shown.

[0021] Fig.12 yes Fig. 9 The multi-site dispensing and / or injection system shown is at the end of the full stroke. Figure 7 The same section as shown (with Figure 8 The detailed longitudinal sectional view taken orthogonally to the section in FIG. 1 ) shows that the complete stroke includes the stroke portion where the inner telescopic member and the outer telescopic member are retracted together.

[0022] Fig.13 and Fig.15 The multi-site dispensing and / or injection system is moved along the same axis as the inner telescopic member after the spring returns its push member and inner telescopic member to the proximal position and the system is ready to deliver a fifth dose of dispensable or injectable fluid. Figure 8 A more specific longitudinal section view of the same section.

[0023] Fig.16 and Fig.17 are perspective and side views of a multi-site dispensing and / or injection system with an administration tip and a cap, according to some embodiments.

[0024] Fig.18 is a detailed perspective view of a multi-site dispensing and / or injection system with an administration tip and a cap according to some embodiments.

[0025] Fig.19 is an exploded detailed perspective view of a multi-site dispensing and / or injection system with an administration tip and a cap according to some embodiments.

[0026] Fig. 20 is a detailed longitudinal cross-sectional view of a multi-site dispensing and / or injection system with an administration tip and a cap according to some embodiments.

[0027] Fig.21 is an exploded detailed perspective view of a multi-site injection system with a needle hub and a cap according to some embodiments.

[0028] Fig. 22 is a detailed longitudinal cross-sectional view of a multi-site injection system having a needle hub and a cap according to some embodiments.

[0029] In order to better understand how to obtain the above and other advantages and purposes of various embodiments, the embodiments are described in more detail with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements of similar structure or function are represented by similar reference numerals throughout the text. It should be understood that these drawings only depict certain illustrated embodiments and should not be considered to limit the scope of the embodiments. DETAILED DESCRIPTION

[0030] Exemplary Multi-Site Dispensing and / or Injection Systems

[0031] Many dispensable or injectable drugs can be used for multiple dispensing, application and / or injection sites on the same patient. Some medical procedures involve the continuous dispensing, application and / or injection of a fixed volume (e.g., 0.1 ml and / or microliter range volume) of a drug (e.g., botulinum toxin or "Botox") at multiple dispensing, application and / or injection sites on a patient. Currently, many drugs are drawn into the dispensing and / or injection system from a medicine bottle, which increases the medical procedure time and the possibility of accidental needle puncture. In addition, some drugs are delivered in viscous solutions, so a larger diameter (e.g., lower gauge: 25 gauge) needle is required for drawing the viscous drug into the dispensing and / or injection system, while a smaller diameter (e.g., higher gauge: 30 gauge, 32 gauge, 34 gauge, sub-34 gauge) needle is used for injection. This needle replacement leads to an increase in medical procedure time and the risk of accidental puncture. The multi-site dispensing and / or injection system described herein solves these problems of current systems.

[0032] Figure 6-Figure 15 A multi-site dispensing and / or injection system 600 is shown according to some embodiments. Figure 6 As shown, the system 600 can be pre-filled with a dispensable or injectable drug. The system 600 includes a syringe body 610, a stop member 620, a plunger member 630, and a finger flange 640. The syringe body 610 includes a syringe flange 612 at its proximal end, and the finger flange 640 is coupled to the syringe flange 612. The syringe body 610 also includes a needle hub coupling member 614 (e.g., a female Luer connector) that is configured to removably couple thereto a needle hub (not shown) that includes a needle (not shown), other dispensing mechanism (not shown), or an application tip / tip (see Figures 16 to 20 ).

[0033] Many of these system components (e.g., the syringe body 610 and the stop member 620, as well as the needle hub (not shown)) can be off-the-shelf / off-the-shelf components to take advantage of existing, well-controlled supply chains, as well as corresponding assembly machinery and personnel. The syringe body 610 can be glass, metal, or a polymeric material, such as COC, COP, polypropylene, polyethylene, or other syringe materials. The stop member 620 can be a rubber, such as butyl rubber, chlorobutyl rubber, bromobutyl rubber, or a polymeric material, such as a thermoplastic elastomer. The stop member 620 can be covered with a protective and / or lubricious coating, such as PTFE or other polymers. An off-the-shelf stop member 620 refers to a commercially available stop member having a substantially smooth distal-facing surface that does not include protrusions or recesses for coupling to a needle.

[0034] The system 600 also includes a push member 650 configured to apply a distal force to the plunger member 630 and the stop member 620 coupled thereto. Figure 6 6, for clarity, the stop member 620 and the plunger member 630 are shown as separated. The distal end of the plunger member 630 includes a distal spike 633, which is configured to engage into the stop member 620. The distal spike 633 of the plunger member 630 includes a shaft portion 634 and a head 635, and the head 635 is configured to prevent the plunger member 630 from being pulled out of the stop member 620. In alternative embodiments, the distal end of the plunger member 630 may include a threaded connection (not shown) with the stop member 620, or may be flat (not shown) and placed on the stop member 620. The push member 650 includes an outer telescopic member 660 at its proximal end. The system 600 further includes an inner telescopic member 670, which is slidably disposed and at least partially within the outer telescopic member 660. In addition, the system 600 includes a thumb pad 680 coupled to the proximal end of the inner telescopic member 670.

[0035] The finger flange 640 includes a proximally protruding tubular member 642. The distal end of the push member 650 is slidably disposed in the proximally protruding tubular member 642. Similarly, the distal end of the inner telescopic member 670 is slidably disposed in the outer telescopic member 660 defined by the push member 650.

[0036] Figure 7 yes Figure 6 A detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system 600 is shown. Figure 7 As shown, the proximally protruding tubular member 642 of the finger flange 640 defines a proximally facing surface 644. The outer telescopic member 660 of the pushing member 650 defines a distally facing surface 662, which is configured to interfere with the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640 to limit the distal movement of the pushing member 650 relative to the finger flange 640. Therefore, the pushing member 650 can only move distally relative to the finger flange 640 by a distance defined by the distance between the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the pushing member 650.

[0037] Likewise Figure 7As shown, the outer telescopic member 660 of the pushing member 650 defines a side opening 664 having a proximally facing wall 666. The inner telescopic member 670 defines a distally tapered member 672 configured to interfere with the proximally facing wall 666 of the side opening 664 of the outer telescopic member 660 of the pushing member 650 to limit the distal movement of the inner telescopic member 670 relative to the outer telescopic member 660 of the pushing member 650. Therefore, the inner telescopic member 670 can only telescope / telescope distally into the outer telescopic member 660 a distance defined by the distance between the proximally facing wall 666 of the side opening 664 of the outer telescopic member 660 of the pushing member 650 and the distally tapered member 670 of the inner telescopic member 670.

[0038] The system 600 further includes a distal spring 690 disposed in the proximally protruding tubular member 642 of the finger flange 640, between and in contact with the finger flange 640 and the push member 650. The distal spring 690 biases the push member 650 proximally away from the finger flange 640. The system 600 further includes a proximal spring 695 disposed in the outer telescopic member 660 defined by the push member 650, between and in contact with the push member 650 and the inner telescopic member 670. The proximal spring 695 biases the inner telescopic member 670 proximally away from the outer telescopic member 660 and the push member 650. In an embodiment where the distal spring 690 is weaker / less stiff than the proximal spring 695, a distal force is applied to the inner telescopic member 670 by the thumb pad 690 such that the force is transmitted to the push member 650 via the proximal spring 695. This transmitted force causes the push member 650 to move distally relative to the finger flange 640 and compresses the distal spring 690 until the distally facing surface 662 of the outer telescopic member 660 of the push member 650 abuts the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640, preventing further distal movement of the push member 650 relative to the finger flange 640. Continued application of the distally directed force compresses the proximal spring 695 to allow the inner telescopic member 670 to retract distally and into the outer telescopic member 660.

[0039] Figure 8 yes Figure 6 and Figure 7 A detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system 600 is shown, the cross-sectional view being taken along the plane corresponding to Figure 7 The plane is cut orthogonal to the section in. Figure 8As shown, the proximal end of the push member 650 defines a pair of distally extending pawls 652, which contact and are operably connected with the ratchet portion 632 of the plunger member 630. The pawl 652 can be made of metal or polymer. The ratchet portion 632 of the plunger member 630 includes a plurality of teeth 634, and the teeth 634 gradually taper toward the distal side. In this way, when the push member 650 moves distally, the pair of distally extending pawls 652 push the corresponding teeth 634 and the plunger member 630 attached thereto toward the distal side. When the push member 650 is returned to the proximal side by means of the distal spring 690, the pair of distally extending pawls 652 can pass over the corresponding teeth 634 and move a group of teeth 634 toward the proximal side. The advancement of the plunger member 630 causes a predetermined dose of dispensable and / or injectable fluid to be discharged from the syringe body 610. Returning the pair of distally extending pawls 652 proximally to a proximal position adjacent the next pair of teeth 634 prepares the system 600 to inject the next dose of the dispensable and / or injectable fluid in a sequential manner.

[0040] Figures 9 to 15 An exemplary method of operating a multi-site dispensing and / or injection system 600 is shown for advancing a plunger member 630 to inject a predetermined dose of a dispensable and / or injectable fluid from a syringe body 610 while preparing the system 600 to inject the next dose of a dispensable and / or injectable fluid in a continuous manner. Figures 9 to 15 In the illustrated dispensing and / or injection system 600, the distal spring 690 is weaker than the proximal spring 695. In other embodiments, the springs 690, 695 can have equal strengths, or the distal spring 690 can be stronger than the proximal spring 695. In this case, the sequence of motions will be different, but the overall operation and function of the device will remain the same. The springs 690, 695 can be adjusted to achieve a variety of force distributions.

[0041] Fig. 9 yes Figures 6 to 8 A detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system 600 is shown, the system 600 having delivered three predetermined doses of a dispensable and / or injectable fluid from the syringe body 610, and the system 600 is ready to deliver a fourth dose of a dispensable and / or injectable fluid. Thus, the pair of distally directed pawls 652 are disposed proximal to the third pair of teeth 634-3. Fig.14 6 is a more longitudinal cross-sectional view of the system 600, showing the relative positions of the pair of distally facing pawls 652 and the third pair of teeth 634-3. In addition, the gap between the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the push member 650 is enlarged because the push member 650 has been moved distally by the distal spring 690 to prepare the system 600 for delivery of the next dose.

[0042] Fig.10 yes Figures 6 to 9 The multi-site dispensing and / or injection system 600 shown is moved toward the push member (via thumb 680, internal telescoping member 670 and proximal spring 695, see Figure 7 ) after applying a force toward the distal side, along Figure 8 Detailed longitudinal cross-sectional view taken from the same section. The distally directed force causes the push member 650 and the outer telescopic member 660 forming a part thereof to move distally. This eliminates the gap between the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the push member 650. This also causes the pair of distally directed pawls 652 to push the third pair of 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 proximally protruding tubular member 642 of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the push member 650. The gap is slightly larger than the distance between the two teeth 634 on the ratchet portion 632 of the plunger member 630 to provide tolerance for the machining of these small parts.

[0043] Fig.11 is along with Figure 6 and Figure 7 The same section (the section is Figures 8 to 10 The section is orthogonal to the Figures 6 to 10 Detailed longitudinal cross-sectional view of a multi-site dispensing and / or injection system 600 shown in FIG. Fig.10 The same configuration as shown. The gap between the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640 and the distally facing surface 662 of the outer telescopic member 660 of the push member 650 is eliminated, preventing the push member 650 from further distally moving relative to the finger flange 640. However, a second gap still exists between the distally tapered member 672 of the inner telescopic member 670 and the proximally facing wall 666 of the side opening 664 of the outer telescopic member 660 of the push member 650. The second gap allows the outer telescopic member 660 of the push member 650 to telescope distally, thereby compressing the proximal spring 695. The relative spring forces of the distal spring 690 and the proximal spring 695 are adjusted so that a typical user cannot distinguish between compressing the distal spring 690 (and delivering a dose of the dispensable and / or injectable fluid) and compressing the proximal spring 695 (and telescoping the inner and outer telescopic members 670, 660 together).

[0044] Fig.12 yes Figures 6 to 11A detailed longitudinal cross-sectional view of a multi-site dispensing and / or injection system 600 is shown, the system being arranged along a plane extending along the axis of the Fig.11 In the same cross-sectional view, after further applying a distal force and retracting the inner and outer telescopic members 670 and 660, a second gap between the distally tapered member 672 of the inner telescopic member 670 and the proximally facing wall 666 of the side opening 664 of the outer telescopic member 660 of the pushing member 650 is eliminated. The retraction of the inner and outer telescopic members 670 and 660 provides a longer stroke relative to the length of one tooth 634 to provide improved tactile feedback to the user.

[0045] Fig.13 and Fig.15 yes Figures 6 to 12 A detailed and even more detailed longitudinal cross-sectional view of the multi-site dispensing and / or injection system 600 is shown, Fig.13 and Fig.15 For along with Figure 8 The same section (the section is Fig.11 and Fig.12 A longitudinal section view taken orthogonally to the section in Figures 6 to 12 The distal force of the illustrated multi-site dispensing and / or injection system 600 has been removed from the system 600, and the distal spring 690 and the proximal spring 695 have returned the push member 650 and the inner telescopic member 672 to their respective proximal positions. Returning the push member 650 to its proximal position moves the pair of distally extending pawls 652 to a proximal position adjacent the next pair of teeth 634 (i.e., the fourth pair of teeth 634-4) in the proximal direction. Resetting the push member 650 and the inner telescopic member 672 to their respective proximal positions prepares the system 600 for injecting the next dose of the dispensable and / or injectable fluid in a continuous manner.

[0046] Although Figures 9 to 15The illustrated embodiment includes a distal spring 690 that 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, applying a distal force to the inner telescoping member 670 through the thumb pad 690 first compresses the proximal spring 695, thereby retracting the inner telescoping member 670 into the outer telescoping member 660. Only after the distally tapered member 672 of the inner telescoping member 670 abuts and interferes with the proximally facing wall 666 of the side opening 664 of the outer telescoping member 660 of the push member 650 is the distally directed force transmitted through the inner telescoping member 670 to move the push member 650 distally. Continued application of the distal force causes the push member 650 to move distally relative to the finger flange 640, thereby delivering a dose of a dispensable and / or injectable fluid. This causes the distal spring 690 to compress until the distally facing surface 662 of the outer telescopic member 660 of the push member 650 abuts the proximally facing surface 644 of the proximally protruding tubular member 642 of the finger flange 640, preventing the push member 650 from moving further distally relative to the finger flange 640, reaching the end of the stroke.

[0047] In other embodiments, the distal spring 690 and the proximal spring 695 may also have the same strength, thereby achieving a smooth spring / spray force distribution, and there is no obvious difference between the movements of the pushing member 650, the inner telescopic member 670 and the thumb pad 680. Although some embodiments are described as compressing another spring (e.g., a stronger spring) before compressing one spring (e.g., a weaker spring), in other embodiments, the distal spring 690 and the proximal spring 695 are compressed / contracted at the same time. The distal and proximal springs 690, 695 can be compressed / contracted at different rates according to their strength. In some embodiments, after the gap between the distally facing surface 662 of the outer telescopic member 660 of the pushing member 650 and the proximally protruding tubular member 642 of the finger flange 640 is closed, the inner telescopic member 670 continues to move a relatively large stroke to improve user feedback. The relative strength of each spring 690, 695 can be adjusted to provide any desired force distribution. Although springs 690, 695 are shown as coil springs loaded in compression, alternative springs such as extension springs and / or leaf springs may be used in various embodiments.

[0048] Applicator Tips and Caps

[0049] Fig.16 and Fig.17 are perspective and side views of a multi-site dispensing system 700 having an application tip (see Fig.19 and Fig. 20 ) and a cap 800. Figures 16 to 20The multi-site dispensing system 700 shown is almost identical to Figures 6 to 15 The multi-site dispensing and / or injection system 600 shown is the same. For example, the multi-site dispensing system 700 includes a syringe body 710, a stop member 720, a plunger member 730, and a finger flange 740. The syringe body 710 includes a syringe flange 712 at its proximal end to 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 a dispensing tip (see Fig.19 and Fig. 20 ) and cap 800. Aspects of multi-site dispensing system 700 similar to aspects of multi-site dispensing and / or injection system 600 have corresponding reference numerals that differ only by the first digit and have similar functionality as aspects of system 600 described above.

[0050] The multi-site dispensing 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, to which the finger flange 740 is coupled. The syringe body 710 also includes a coupling member 714 (e.g., a female Luer connector) and a dispensing tip (see Fig.19 and Fig. 20 ). The cap 800 is removably coupled to the dispensing tip.

[0051] Finger flange 740 includes a proximally protruding tubular member 742. System 700 also includes an outer telescopic member 760 formed at a proximal end of a push member (not shown). System 700 further includes an inner telescopic member 770 that is slidably and at least partially disposed within outer telescopic member 760. Thumb pad 780 is coupled to the proximal end of inner telescopic member 770. Fig.19 and Fig. 20 As shown, the dispensing tip / nozzle 900 is coupled to a coupling member 714 (female Luer connector) molded into the distal end of the syringe body 710, for example, via a male Luer connector. In turn, the cap 800 is removably attached to the dispensing tip 900. In embodiments that include a connector (e.g., a Luer connector), the dispensing tip 900 can be attached to the syringe body 710 by the user just prior to dispensing. In other embodiments, the dispensing tip 900 is welded to the syringe body 710 during manufacturing. The dispensing tip 900 is configured to dispense a substance (e.g., a liquid or gel) multiple times from the syringe body 710.

[0052] The cap 800 may include a rigid polymer outer shell 810 and a resilient inner member 820 that may form a seal around the interior surface of the cap 800. When the user is ready to dispense, they may pull down the cap 800 and depress the thumb pad 780. When dispensing is complete, the user may replace the cap 800 to prevent contamination and / or accidental dispensing.

[0053] Fig.18 is a detailed perspective view of a multi-site dispensing system with an applicator tip and a cap, according to some embodiments. Fig.19 is an exploded detailed perspective view of a multi-site dispensing system having an applicator tip and a cap according to some embodiments. Fig. 20 is a detailed longitudinal cross-sectional view of a multi-site dispensing system having an applicator tip and a cap according to some embodiments.

[0054] like Fig. 20 As shown, there is an elastomeric seal 910 between the dispensing tip 900 and the Luer cone 716 of the coupling member 714 of the syringe body 710, which is slightly compressed during the assembly process. The seal 910 prevents fluid from leaking into the threaded area of ​​the coupling member 714 of the syringe body 710, without relying on the press fit between the coupling member 714 of the syringe body 710 and the concentric cones of the cap 800. The dispensing tip 900 defines a recessed ring 920, which facilitates the removable connection of the cap 800 when the resilient inner member 820 expands into the recessed ring 920. The dispensing tip 900 helps control the cylinder diameter of the thicker fluid (drug) being extruded to increase the extrusion length. The dispensing tip 900 also includes a connector 930 (eg, a male Luer connector) that is disposed in the gap between the Luer cone 716 and the threaded collar 718 of the syringe body 710, thereby minimizing loss of the processed fluid / drug in the gap.

[0055] Multi-site injection system

[0056] Fig.21 is an exploded detailed perspective view of a multi-site injection system 1000 having 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 having a needle hub 1100 and a cap 800 according to some embodiments.

[0057] Figure 21 to Figure 22 The multi-site injection system 1000 shown is Figures 6 to 15 The multi-site dispensing and / or injection system 600 and Figures 16 to 20The illustrated multi-site dispensing system 700 is nearly identical. The only difference between these systems 600, 700, 1000 is that system 1000 includes a needle hub 1100. Aspects of the multi-site injection system 1000 that are similar to aspects of the multi-site dispensing and / or injection systems 600, 700 have corresponding reference numerals that differ only in the first digit and have similar functions as the aspects of the above-described system 600. Needle hub 1100 includes a needle 1110 that is configured to inject a substance (e.g., a liquid or gel) from a syringe body 710 multiple times into a patient's body.

[0058] Although the dispensing and / or injection systems depicted and described herein include syringes with Luer connections, the multi-site dispensing and / or injection systems described herein can be used with staked needles, cartridges, autoinjectors, etc. The multi-site dispensing and / or injection systems described herein can also be used with a safety dispensing and / or injection system.

[0059] Various exemplary embodiments of the present invention are described herein. Reference is made to these examples in a non-restrictive sense. They are provided to illustrate the more widely applicable aspects of the present invention. Various changes may be made to the described invention and equivalents may be substituted without departing from the true spirit and scope of the present invention. In addition, many modifications may be made to adapt specific circumstances, materials, compositions of matter, methods / processes, process operations or steps to the purpose, spirit or scope of the present invention. In addition, it will be appreciated by those skilled in the art that each individual variation described and illustrated herein has discrete components and features that may be easily separated or combined from the features of any other several embodiments without departing from the scope or spirit of the present invention. All of these modifications are within the scope of the claims associated with the present disclosure.

[0060] Any of the devices described for performing the subject diagnostic or interventional procedures may be provided in a packaged combination for use in performing such interventions. These supply "kits" may further include instructions for use and be packaged in sterile trays or containers commonly used for this purpose.

[0061] The present invention includes methods that can be implemented using the subject apparatus. The method can include an act of providing such suitable apparatus. Such provision can be performed by an end user. In other words, the act of "providing" simply requires the end user to obtain, access, approach, locate, set up, activate, energize / power on, or otherwise provide the necessary apparatus in the subject method. The methods described herein can be performed in any order of the recorded events that is logically possible, as well as the described order of events.

[0062] Exemplary aspects of the invention and details about material selection and manufacturing have been set forth above. As for other details of the invention, these can be understood in conjunction with the patents and publications cited above and what is generally known or understood by those skilled in the art. For example, it will be understood by those skilled in the art that, for example, if desired, one or more lubricious coatings (e.g., hydrophilic polymers, such as compositions based on polyvinyl pyrrolidone, fluoropolymers, such as tetrafluoroethylene, PTFE, ETFE, hydrophilic gels or silicones) can be used in conjunction with various parts of the device (e.g., relatively large interface surfaces of removable coupling components) to facilitate low-friction manipulation or propulsion of these objects relative to other parts of the device or nearby tissue structures. This is also true for the method-based aspects of the invention in terms of additional actions that are typically or logically employed.

[0063] Furthermore, although the invention has been described with reference to several examples optionally incorporating various features, the invention is not limited to what is described or indicated for the various variations of the invention. Various changes may be made to the described invention, and equivalents (whether referenced herein or not included for brevity) may be substituted without departing from the true spirit and scope of the invention. Furthermore, where a numerical range is provided, it is to be understood that each intermediate value between the upper / lower limit of the range and any other stated value or intermediate value within the stated range is included within the invention.

[0064] In addition, it is contemplated that any optional features of the invention variations may be independently elaborated and claimed, or combined with any one or more features described herein. References to singular items include the possibility of multiple identical items. More specifically, as used herein and in the related claims, the singular forms "one", "an", "said" and "the" include plural objects unless otherwise specifically stated. In other words, the use of articles indicates that the items involved in "at least one" in the preceding description and claims related to the present disclosure may be referred to. It should also be noted that such claims may be written to exclude any optional elements. Therefore, this statement is intended to be used as a premise basis for the use of such exclusive terms such as "solely", "only" and the like related to the definition of claim elements or the use of "negative" type restrictions.

[0065] In the absence of such exclusive terms, the term "comprising" in the claims related to the present disclosure shall allow for the inclusion of any additional elements, regardless of whether a given number of elements are recited in such claims or the additional features may be considered to transform the nature of the elements recited in such claims. Unless otherwise specifically defined herein, all technical and scientific terms used herein are given the broadest commonly understood meaning possible while maintaining claim validity.

[0066] The scope of the present invention is not limited to the examples provided and / or the description referred to, but is limited only by the scope of the claims language associated with this disclosure.

Claims

1. A system for fluid delivery, the system comprising: a syringe body having a proximal end and a distal end, a syringe interior, and a syringe flange at the proximal end of the syringe body; The fluid placed inside the syringe; a finger flange coupled to a syringe flange; a stop member disposed inside the syringe; a plunger member coupled to the stop member and having a ratchet portion; a push member coaxially disposed about at least a portion of the plunger member and operably coupled thereto, the push member having an outer telescoping member disposed at a proximal end thereof; an inner telescopic member slidably and at least partially disposed within the outer telescopic member and operably coupled to the outer telescopic member; and A thumb pad is configured to be coupled to the proximal end of the inner telescopic member.

2. The system according to claim 1, wherein: The finger flange includes a proximally projecting tubular member, and Wherein, the distal end of the pushing member is arranged in a tubular member protruding toward the proximal side.

3. The system according to claim 2, wherein: The proximally projecting tubular member of the finger flange defines a proximally facing surface, and wherein the outer telescopic member of the push member defines a distally facing surface configured to interfere with a proximally facing surface of the proximally protruding tubular member of the finger flange to limit distal movement of the push member relative to the finger flange.

4. The system according to claim 3, wherein: The outer telescoping member of the push member defines a side opening having a proximally facing wall, and The inner telescopic member defines a distally tapered member configured to interfere with a proximally facing wall of a side opening of the outer telescopic member of the push member to limit distal movement of the inner telescopic member relative to the outer telescopic member of the push member.

5. The system of claim 4, further comprising a distal spring disposed in the proximally protruding tubular member of the finger flange, located between and in contact with the finger flange and the push member.

6. The system of claim 5, further comprising a proximal spring disposed in the outer telescopic member of the pushing member, between the pushing member and the inner telescopic member and in contact with them.

7. The system according to claim 6, wherein: The distal spring is of lower strength than the proximal spring and has a relatively small preload in a static state, such that application of a distally directed force to the inner telescopic member by the thumb pad initially compresses the distal spring until a distally facing surface of the push member abuts a proximally facing surface of the proximally projecting tubular member of the finger flange before compressing the proximal spring to allow the inner telescopic member to move distally relative to the outer telescopic member.

8. The system according to claim 6, wherein: The distal spring is stronger and has a greater preload at rest than the proximal spring, so that applying a distally directed force to the inner telescopic member via the thumb pad initially compresses the proximal spring until a distally tapered member of the inner telescopic member abuts a proximally facing wall of the outer telescopic member of the push member before compressing the distal spring to allow the push member to move distally relative to the finger flange.

9. The system according to claim 6, wherein: The distal spring and the proximal spring have equal strengths so that the pushing member and the inner telescopic member move simultaneously.

10. The system according to claim 1, wherein: The push member includes a distally extending pawl that contacts and is operably coupled to a ratchet portion of the plunger member.

11. The system according to claim 10, wherein: The ratchet portion of the plunger member includes a plurality of teeth.

12. The system according to claim 11, wherein: Sufficient depression of the thumb pad relative to the finger flange advances the plunger member distally relative to the syringe body by a distance of one of the plurality of teeth.

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