Exostructure to assist in accurate syringe injection

Abstract

Devices for delivery of individual units of a medicament and methods for their use are provided. Such a delivery device comprises an exostructure permanently attached to a syringe comprising a barrel and a plunger with one or more ratchet surfaces, a cam mechanism to advance the plunger a plurality of set distances in a first direction to deliver a single individual unit of the medicament per each set distance, and a locking pawl to prevent the plunger from being retracted in a second direction opposite the first by interfacing with the ratchet surfaces. The locking pawl also produces tactile feedback, audible feedback, or both when the plunger is depressed to advance the plunger the set distance. Each of the individual units comprise a measured volume of the medicament, and the plunger can repeatedly be depressed and repeatedly engage with the locking pawl to deliver repeated measured volumes of the medicament.

Claims

1. A device for delivery of one or more individual units of a medicament, the device comprising: a) an exostructure configured to be attached to a syringe; b) a locking pawl assembly comprising a locking pawl and a yoke integrally connected to the locking pawl by a living hinge, wherein the yoke is configured to at least partially surround a plunger bar; wherein the locking pawl assembly is operatively coupled to the exostructure and configured to allow the plunger bar to be advanced a plurality of set distances in a first direction to deliver a single individual unit of the one or more individual units of the medicament per each set distance of the plurality of set distances; wherein the locking pawl assembly is configured to prevent the plunger bar from being retracted in a second direction opposite the first direction; wherein the locking pawl assembly produces tactile feedback, audible feedback, or both when the plunger bar is depressed to advance the plunger bar the set distance of the plurality of set distances, wherein the exostructure encases the locking pawl assembly: and wherein an interior of the exostructure comprises a slot for receiving a flange of the syringe.

2. The device of claim 1, wherein the exostructure is permanently attached to the syringe.

3. The device of claim 1, wherein the syringe is disposable.

4. The device of claim 1, wherein the plunger bar further comprises one or more ratchet surfaces.

5. The device of claim 4, wherein the locking pawl engages with the one or more ratchet surfaces of the plunger bar to allow depression of the plunger bar in the first direction, while preventing the plunger bar from being retracted in the second direction.

6. The device of claim 5, wherein engagement of the locking pawl with the one or more ratchet surfaces of the plunger bar produces tactile feedback, audible feedback, or both when the plunger bar is depressed.

7. The device of claim 1, wherein each of the one or more individual units of the medicament comprise a measured volume of the medicament, wherein the medicament is contained within a barrel of the syringe.

8. The device of claim 7, wherein depression of the plunger bar in the first direction delivers the medicament; wherein the medicament comprises a liquid.

9. The device of claim 8, wherein the depression of the plunger bar in the first direction delivers the measured volume of the liquid comprising a volume of between about 0.01 mL to 0.1 mL.

10. The device of claim 9, wherein the depression of the plunger bar in the first direction delivers the measured volume of the liquid comprising a volume of between about 0.025 mL to 0.05 mL.

11. The device of claim 1, wherein the plunger bar can repeatedly be depressed in the first direction and repeatedly engage with the locking pawl to deliver repeated measured volumes of the medicament.

12. The device of claim 1, wherein the plunger bar can repeatedly be depressed to deliver between about 10 individual units of the medicament and about 100 individual units of the medicament.

13. The device of claim 12, wherein the plunger bar can repeatedly be depressed to deliver between about 20 individual units of the medicament and about 60 individual units of the medicament.

14. The device of claim 1, wherein the exostructure encases the locking pawl assembly such that the exostructure prevents external access to the locking pawl assembly.

15. The device of claim 1, wherein the locking pawl assembly is pivotally activated.

16. The device of claim 1, wherein the syringe is disposable while attached to the exostructure.

17. The device of claim 1, wherein the syringe comprises a syringe plunger and a syringe barrel.

18. The device of claim 1, wherein the syringe comprises a syringe barrel, and wherein the exostructure is configured to encompass a full circumference of the syringe barrel over at least an axial length thereof.

19. The device of claim 1, wherein the slot for receiving the flange of the syringe is positioned adjacent to the locking pawl assembly within the exostructure.

20. A method for delivering one or more individual units of a medicament, the method comprising: a) delivering the one or more individual units of the medicament from a syringe when a plunger bar is depressed in a first direction; b) preventing the plunger bar from being retracted in a second direction opposite the first direction with a locking pawl assembly engaging the plunger bar, wherein the locking pawl assembly comprises a locking pawl and a yoke integrally connected to the locking pawl by a living hinge, wherein the yoke is configured to at least partially surround the plunger bar, wherein the locking pawl assembly produces tactile feedback, audible feedback, or both tactile and audible feedback in response to movement of the plunger bar in the first direction, wherein an exostructure encases the locking pawl assembly, and wherein an interior of the exostructure comprises a slot for receiving a flange of the syringe.

21. The method of claim 20, wherein the syringe comprises a syringe plunger and a syringe barrel.

22. A method for delivering one or more individual units of a medicament, the method comprising: a) depressing a plunger bar in a first direction to deliver the one or more individual units of the medicament from a syringe; b) wherein, as the plunger bar is depressed, a locking pawl assembly engages the plunger bar to prevent the plunger bar from being retracted in a second direction opposite the first direction, wherein the locking pawl assembly comprises a locking pawl and a yoke integrally connected to the locking pawl by a living hinge, wherein the yoke is configured to at least partially surround the plunger bar, wherein the locking pawl assembly produces tactile feedback, audible feedback, or both in response to movement of the plunger bar in the first direction, wherein an exostructure encases the locking pawl assembly, and wherein an interior of the exostructure comprises a slot for receiving a flange of the syringe.

23. The method of claim 22, wherein the syringe comprises a syringe plunger and a syringe barrel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the figure number in which that element is first introduced.

(2) FIG. 1 illustrates a first embodiment of a syringe exostructure constructed in accordance with the principles of the present invention shown in an exploded view.

(3) FIG. 2 illustrates a top view of the syringe exostructure of FIG. 1.

(4) FIG. 3 illustrates a lateral view of the syringe exostructure of FIG. 1.

(5) FIG. 4 is a view of a proximal or plunger end of the syringe exostructure of FIG. 1.

(6) FIG. 5 is a perspective view of a second, exemplary embodiment of a syringe exostructure constructed in accordance with the principles of the present invention.

(7) FIG. 6 illustrates an exemplary plunger bar incorporated into the embodiment of FIG. 5.

(8) FIG. 7 illustrates an exemplary drive plunger incorporated into the embodiment of FIG. 5.

(9) FIG. 8 illustrates an exemplary T-handle incorporated into the embodiment of FIG. 5.

(10) FIG. 9 illustrates an exemplary locking pawl assembly incorporated into the embodiment of FIG. 5.

(11) FIG. 10 illustrates an exemplary lower cap or bracket incorporated into the embodiment of FIG. 5.

(12) FIG. 12 is a detailed, exploded view showing details of the drive pawl and the locking pawl as they engage the plunger bar in the embodiment of FIG. 5.

(13) FIG. 11 is a side, sectional view of the syringe exostructure embodiment of FIG. 5.

(14) FIG. 13 is a detailed view of an upper portion of the syringe exostructure of FIG. 5 showing engagement of the plunger button of a syringe by the drive plunger.

(15) FIGS. 14A through 14C illustrate in a step-wise fashion how the drive pawl and locking pawl advance the drive plunger in accordance with the methods of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(16) A syringe exostructure device to assist in the accurate delivery of individual units from a standard, single-use, disposable syringe filled with multiple doses. The syringe exostructure is single-use and disposable, and can be configured to support different syringe sizes and dosing requirements. The syringe exostructure includes formed features that ergonomically replicate the impression of a standard syringe. The syringe exostructure retains a syringe in place while a cam mechanism advances the syringe's plunger a set distance into the barrel to expel a measured volume with each compression of the exoskeleton plunger. Tactile and/or audible feedback(s) are provided when the plunger is compressed. The filled syringe is retained within a main body of the syringe exostructure and secured in place by the formed features and a hinged door that closes permanently and is tamper proof.

(17) The plunger button of the syringe engages a plunger bar that advances a set distance towards the flange and the barrel when the plunger is compressed. The advancement of the plunger bar is driven by a set of driving pawls connected to the plunger that rake the plunger bar forward then disengage to return with the plunger to their starting position and reengage plunger bar closer to the plunger button. The distance traveled by the plunger head to the plunger shroud corresponds to the distance traveled by the locking pawl between each tooth of the set of locking teeth. During each advancement of the plunger bar, a locking pawl disengages the plunger bar and reengages when the plunger returns to the starting position, preventing the plunger bar from reversing direction. When the contents of the syringe have been expelled, the entire exostructure with syringe intact is discarded and cannot be reused.

(18) A syringe exostructure in one aspect includes a main body front with a barrel groove, flange slot, and a plunger shroud; a plunger bar with a plunger button mount; a set of locking teeth; and a set of driving teeth. The plunger used with the syringe exostructure includes a plunger head, a plunger spring, a set of driving pawls, a pawl spring, and a fastener coupling: the pawl spring and the set of driving pawls to the plunger. A main body back portion of the exostructure includes a locking pawl and a spring mount.

(19) The barrel groove is enclosably aligned to a hinged door attached to the main body front, and the plunger button is moveably positioned between the flange slot and the plunger head. The plunger shroud is positioned between the flange slot and the plunger head. The set of driving teeth is detachably coupled to the set of driving pawls by way of the pawl spring, which is elastically engaged to the spring mount opposite the plunger head. The locking pawl is detachably coupled to the set of locking teeth.

(20) Referencing FIG. 1, a syringe exostructure 100 includes a door 102, a hinge pin 106, a main body front 108, a plunger bar 110, a fastener 112, a first driving pawl 114, a pawl spring 116, and a second driving pawl 118. A plunger 120 includes a plunger head 134, and a main body back 122 includes a locking pawl 126 and a spring mount 144. The plunger bar 110 includes a plunger button mount 136. The main body front 108 includes a barrel groove 142, flange slot 138, and a plunger shroud 140.

(21) The syringe exostructure 100 engages a standard disposable syringe 104 that includes a barrel 128, a flange 130, and a plunger button 132. The syringe exostructure 100 delivers a highly controlled volume of fluid from a syringe 104 upon compression of the plunger 120. The main body front 108 includes a formed cavity to receive the syringe 104. The formed cavity includes structures for retaining the flange 130 and barrel 128 of the syringe 104. The flange slot 138 is surrounded by protruding structures resembling an enlarged version of the flange 130. The main body front 108 includes hinges for mounting a door 102 adjacent to the barrel of the syringe 104. The hinges of the door 102 and the main body front 108 are secured through a hinge pin 106. While secured with the hinge pin 106, the door 102 swings to enclose the barrel 128 of the syringe 104 within the formed cavity of the main body front 108.

(22) The plunger bar 110 engages the plunger button 132 of the syringe 104. The plunger bar 110, the plunger 120, and main body back 122 are coincidently aligned along the length of the syringe 104. The plunger bar 110 is operatively coupled to the plunger 120 through a first driving pawl 114 and a second driving pawl 118, as well as to a main body back 122 through a locking pawl 126. The first driving pawl 114 and the second driving pawl 118 are mounted to the plunger 120 through a fastener 112. The first driving pawl 114 and the second driving pawl 118 elastically engage the plunger bar 110 by way of a pawl spring 116. The plunger head 134 of the plunger 120 protrudes from the main body back 122. The plunger 120 is elastically coupled to the main body back 122 through a plunger spring 124. The locking pawl 126 of the main body back 122 traverses a slotted opening through the bottom of the plunger 120 to engage the plunger bar 110 on a side opposite the syringe 104.

(23) During operation of the syringe exostructure 100, the plunger head 134 is pushed in towards the main body back 122 until the plunger head 134 is coincident with the main body back 122. Movement of the plunger head 134 towards the main body back 122 extrudes the fluid from the barrel 128 of the syringe 104. The extrusion occurs when the first driving pawl 114 and the second driving pawl 118 move the plunger bar 110 to drive the plunger button mount 136 towards the flange 130, pushing the plunger button 132 into the barrel 128. The first driving pawl 114 and the second driving pawl 118 drive the movement of the plunger bar 110 towards the flange 130 and reposition the locking pawl 126 closer to the plunger button 132 during compression of the plunger spring 124.

(24) When the plunger head 134 is released, the pawl spring 116 compresses, allowing the first driving pawl 114 and the second driving pawl 118 to move up the length of the plunger bar 110 towards the plunger button 132 as the plunger 120 returns to the starting position. The plunger bar 110 is kept in place relative to the movement of the plunger 120 through the engagement of the locking pawl 126. The travel distance of the plunger head 134 towards the main body back 122 is a set distance consistent with the travel distance of the locking pawl 126 along the plunger bar 110, resulting in a consistent volume extruded for each compression of the plunger head 134. The locking pawl 126 typically engages a toothed or ratcheted surface formed on the bottom of the plunger bar 110 to allow advancement of the plunger bar as the plunger [is] 120 is depressed and prevent retraction of the plunger bar as the plunger returns to its initial position. Usually, the locking pawl 126 will also provide audible and/or tactile feedback as the toothed or ratcheted bottom of the plunger 120 is advanced by the plunger bar 110 over the locking pawl.

(25) FIG. 2 illustrates a front view of an embodiment of a syringe exostructure 100, and shows the door 102, the main body front 108, the flange 130, the plunger button 132, the plunger head 134, the plunger button mount 136, the flange slot 138, and the plunger shroud 140.

(26) FIG. 3 illustrates a lateral view of the syringe exostructure 100, and shows the door 102, the main body front 108, the main body back 122; the plunger head 134, and the flange slot 138.

(27) FIG. 4 illustrates a top elevational view of an embodiment of the syringe exostructure 100, showing the main body front 108, the main body back 122, and the plunger head 134.

(28) A second embodiment of the syringe exostructure of the present invention is illustrated in FIGS. 5 through 14A-14C. Referring in particular to FIGS. 5 through 11, a syringe exostructure 200 comprises a main body having a lower portion 202a and an upper portion 202b. A T-handle 204 is secured to the main body between the upper and lower portions. A drive plunger 206 and a plunger bar 208 are mounted in the upper portion of the main body 202b, typically in a channel 203, as best seen in FIG. 5.

(29) The plunger bar 208 will typically have a plurality of ratchet teeth formed on a front surface thereof comprising a toothed ratchet surface 210. The toothed ratchet surface allows reciprocation of the drive plunger 206 to incrementally advance the plunger bar 208, will be described in greater detail below.

(30) A conventional syringe S comprises a barrel BR with a syringe plunger SP and a plunger button SB. A lower end of the syringe S above needle N is held in place by a lower cap or bracket 212 of the exoskeleton, while flanges F on a middle portion of the syringe are held in a slot 236 in the T-handle 204, and an upper end of the syringe is held by attaching the plunger button SB in a slot 246 in a button mount 244 in of the plunger bar 208 as seen in FIG. 13. The syringe plunger SP passes downwardly through a cut out 248 in the button mount 244.

(31) Referring now to FIG. 7, the drive plunger 206 has a head 224 which is manually depressed by the user, typically using a thumb, and a channel 226 is formed in a front surface of the head for receiving the plunger bar 208, as best observed in FIGS. 12 and 13. A window 228 is formed in a lower end just of the drive plunger 206 above a drive pawl 230, where the structure of the window and drive pawl together form a living hinge 231 as also be seen in FIG. 12.

(32) Details of the T-handle 204 can be seen in FIG. 8. The T-handle includes a base 234 having a pair of lateral phalanges 235 at its upper end. The base 234 has a passage 240 which receives the main body of the syringe, as best seen in FIG. 5. A slot 236 formed in the front face of the T-handle 204 removably receives the phalange on the syringe where the syringe plunger SP passes upwardly through the groove 238.

(33) A locking pawl assembly 216 is illustrated in FIG. 9. The assembly includes a locking pawl 218 formed at its lower end and a yoke 220 formed at its upper end. The locking pawl 218 is attached to the yoke by a living hinge 219 which allows pivoting or flexing of the locking pawl as forces are imparted to the pawl by the toothed ratchet surface 210 of the plunger bar 208, as described in more detail herein below.

(34) Referring now to FIG. 10, the lower cap or bracket 212 comprises a ring 213 which is received round the lower end of the lower portion 202a of the main body. A clasp or bracket 214 is formed on its front surface to removably receive a lower end of the syringe, as best seen in FIG. 5.

(35) Referring now to FIG. 11, the assembly of the syringe S in the syringe exostructure 200 is shown in partial section. In particular, it can be seen that the syringe button SB is received in the button mount 244 of the plunger bar 208 while a lower end of the toothed ratchet surface 210 of the plunger bar is engaged by the locking pawl 218 and the drive pawl 230.

(36) Referring now to FIGS. 11 and 12, the drive pawl 230 initially engages a lower tooth of the toothed ratchet surface 210 when the syringe is unused and the syringe plunger has not been depressed. The locking pawl 218 also engages the toothed ratchet surface 210 through a window 228 formed in the drive plunger 206, and is coupled to a lower end of the drive plunger 206 by a living hinge 231, as shown in FIG. 13. A channel 203 of the upper portion 202b of the main body receives the drive plunger 206, and, in turn, the channel 226 and the drive plunger slidably receives the plunger bar 208. The syringe plunger SP is mounted so that the plunger button SB is in the slot 246.

(37) Referring now to FIGS. 14A through 14C, advancement of the syringe plunger SP by sequentially depressing the drive plunger head 224 will be describe. The drive plunger 206 and plunger bar 208 are shown in their initial configuration in FIG. 14A with the plunger bar fully extended vertically, as shown in FIGS. 5 and 11. By depressing the drive plunger head 224, the drive pawl 230 on drive plunger 206, is driven downwardly while engaging a lower tooth on the toothed ratchet surface 210 of the plunger bar 208. As the plunger bar 208 moves downwardly, the locking pawl 218 displaces rightwardly (relative to the images in FIGS. 14A-14C) and allows the adjacent tooth to pass downwardly past the locking pawl. After the drive plunger 206 has been fully depressed, the plunger bar 208 is in the configuration shown in FIG. 14, with the syringe plunger having been correspondingly depressed to dispense a dose of the medicament. After full depression of the drive plunger 206, spring 252 will cause the drive plunger to move back upwardly, as shown in FIG. 14C. Engagement of the locking pawl 218 against the adjacent tooth on the toothed ratchet surface 210 will immobilize the plunger bar 208 so that the plunger bar stays in place as the drive plunger moves upwardly back to its initial position. The drive pawl 230 will displace rightwardly as the adjacent tooth moves upwardly in a conventional ratcheting motion. As shown in FIG. 14C, the plunger bar 208 is now displaced downwardly by a notch relative to its initial position as shown in FIG. 14A. Depressing the drive plunger 206 can be repeated to sequentially depress the plunger bar 208 in order to deliver multiple doses of the medicament until the plunger bar 208 is fully extended and the medicament fully delivered from the syringe.

(38) The foregoing examples are not intended to limit the scope of the invention. All modifications, equivalents and alternatives are within the scope of the invention.