MEAT INJECTION DEVICE WITH A SELF-ADJUSTING POSITION REFERENCE AND AUTOMATIC REFILL
20210112819 ยท 2021-04-22
Inventors
Cpc classification
A61M5/3158
HUMAN NECESSITIES
A61M2005/3152
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/3287
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61M5/31511
HUMAN NECESSITIES
A23V2002/00
HUMAN NECESSITIES
A61M5/31578
HUMAN NECESSITIES
A61M5/31505
HUMAN NECESSITIES
A61M5/31585
HUMAN NECESSITIES
A61M5/31576
HUMAN NECESSITIES
A61B17/8822
HUMAN NECESSITIES
A61M2005/2073
HUMAN NECESSITIES
International classification
Abstract
An automatic injection control device injects fluid at a rate directly related to the displacement rate of the device body from a held positioning member. The device has a syringe end, a gripping end, a syringe barrel coupled to the body and a refillable reservoir and at least one directional valve at the syringe end of the body. The directional valves permitting refilling of the refillable reservoir without removing the syringe barrel. Also, a transmission system is coupled to the body, as well as the positioning member, a syringe plunging member, and a gearing mechanism linking the positioning member to the syringe plunging member. The device is designed so that when the positioning member is held in a fixed extended position and the body is pulled by the gripping end, the transmission system provides a one-way motion of the syringe plunging member to precisely inject fluid from the device.
Claims
1. An injection control device, comprising: a body having a syringe end and a gripping end; a syringe barrel coupled to the body; a refillable reservoir and at least one directional valve, disposed at the syringe end of the body, one of the at least one directional valves permitting refilling of the refillable reservoir without removing the syringe barrel; and a transmission system coupled to the body, comprising: a positioning member coupled to the transmission system and extendable from the syringe end of the body; a syringe plunging member coupled to the transmission system; and a gearing mechanism linking the positioning member to the syringe plunging member, wherein when the positioning member is held in a fixed position and the body is pulled by the gripping end, the transmission system provides a one-way motion of the syringe plunging member to inject fluid from the device, a rate of the injected fluid being directly related to a rate of displacement of the body from the held positioning member.
2. The injection control device of claim 1, wherein the refillable reservoir is automatically refilled with injectate if the one of the at least one directional valves is connected to an injectate supply as the positioning member is returned to a resting, non-extended state.
3. The injection control device of claim 1, further comprising a cannula coupled to the syringe end.
4. The injection control device of claim 1, wherein the gearing mechanism comprises a plurality of gears, at least one gear contacting the positioning member and at least one other gear contacting the syringe plunging member.
5. The injection control device of claim 1, further comprising, a retraction mechanism coupled to the syringe plunging member or to a piston within the refillable reservoir, configured to provide a returning action to the positioning member upon its release from being held, wherein the returning action engages the transmission system to withdraw the syringe plunging member and automatically refill the refillable reservoir from injectate entering the one of the at least one directional valves.
6. The injection control device of claim 5, wherein the retraction mechanism is a spring.
7. The injection control device of claim 3, where another of the at least one directional valves is configured to prevent injectate from being drawn back into the refillable reservoir from the cannula.
8. The injection control device of claim 7, wherein the another of the at least one directional valves only provides flow from the refillable reservoir to the cannula.
9. The injection control device of claim 1, wherein the one of the at least one directional valves is displaced from the refillable reservoir and connected to a refill tube.
10. The injection control device of claim 1, further comprising a container of injectate connected to a refill tube connected to the at least one directional valve, wherein the container is either pressurized or non-pressurized.
11. The injection control device of claim 1, further comprising a refill vial, coupled directly or indirectly to the one of the at least one directional valves.
12. The injection control device of claim 1, wherein the at least one directional valves and switchable from bi-directional to unidirectional.
13. The injection control device of claim 1, further comprising a movable piston within the refillable reservoir and coupled to the syringe plunging member.
14. An injection control device, comprising: a body having a syringe end and a gripping end; a syringe barrel coupled to the body; one or more injectate-refillable means disposed proximal to the syringe end of the body; a flow control means coupled to the injectate-refillable means; a transmission means coupled to the body, comprising: a positioning means coupled to the transmission means and extendable from the syringe end of the body; a syringe plunging means coupled to the transmission means; and a linking means linking the positioning means to the syringe plunging means, wherein when the positioning means is held in a fixed position and the body is pulled by the gripping end, the transmission means provides a one-way motion of the syringe plunging means to inject fluid from the device, a rate of the injected fluid being directly related to a rate of displacement of the body from the held positioning means.
15. The injection control device of claim 14, wherein the injectate-refillable is automatically refilled with injectate if the one of the at least flow control means is connected to an injectate supply as the positioning means is returned to a resting, non-extended state.
16. The injection control device of claim 14 wherein the linking means contacts the positioning means and the syringe plunging means.
17. The injection control device of claim 14, further comprising, a retraction means coupled to the syringe plunging means or to the injectate-refillable means, configured to provide a returning action to the positioning means upon its release from being held, wherein the returning action engages the transmission means to withdraw the syringe plunging means and automatically refill the injectate-refillable means from injectate entering the flow control means.
18. The injection control device of claim 14, another flow control means disposed at the syringe end of the body to prevent injectate from being drawn back into the injectate refillable means from a cannula.
19. A method for refilling an injection control device without replacing a syringe barrel, comprising: coupling a refillable reservoir and at least one directional valve, to a syringe of an injection control device body having a syringe end and a gripping end; coupling a transmission system to the body; coupling a positioning member to the transmission system, the positioning member being extendable from the syringe end of the body; coupling a syringe plunging member to the transmission system, the syringe plunging member be movable by the transmission system; linking a gearing mechanism to the positioning member and to the syringe plunging member; and refilling the refillable reservoir by retracting the positioning member, a motion of the positioning member operating on the transmission system to cause the syringe plunging member to retract from the refillable reservoir and create a suction to cause injectate to flow into the refillable reservoir from an external source coupled to the at least one directional valve.
20. The method of 19, further comprising coupling a retraction mechanism to at least one of the syringe plunging member and refillable reservoir, to automatically cause the positioning member to retract back to a non-extended state, wherein the refillable reservoir is filled from an external pressurized or non-pressurized injectate container.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012]
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DETAILED DESCRIPTION OF THE DRAWINGS
[0028] The claimed subject matter is now described with reference to the drawings. Reference to the above incorporated application(s)/patent(s) provide extensive descriptions on the mechanics for achieving semi-automatic, rate-specific delivery/extraction. In particular, the incorporated embodiments are shown where, in most instances, the positioning guide is manually extended/operated to establish a reference position for when the cannula and plunger are simultaneously operated in synchronicity (i.e., coordinated via mechanical means to move in direct proportion to each other). For example, in an injection scenario, the positioning guide is manually held in position against the tissue, by the user while the injection control device (ICD) is being pulled away (toward) during operation. Further, upon completion of the injection the device's syringe barrel must be manually refilled, typically by removing the spent barrel and inserting a fresh barrel with injectate material.
[0029] In various embodiments as now described in this disclosure, the configuration of the injection control device (ICD) is such that the injectate is automatically drawn into the ICD's syringe barrel or proxy to it from a separate larger container of injectate. A flow-controlled valve controls the entry of the injectate into the syringe barrel (or proxy), thus enabling rapid refilling of the syringe barrel, without resorting to the removal and insertion of the syringe barrel from the ICD Thereby, a user can simply inject and re-inject in rapid succession since the syringe barrel or poxy to it is automatically refilled.
[0030] Aspects of the operation of a simple ICD's controlled injection scheme (e.g., consistent rate/volume of injectate per cannula movement rate) is described in the following
[0031]
[0032] The body 18 is illustrated as containing a latch 19 which operates to secure the upper and lower portions of the body 18, during assembly. The body 18 accommodates an exposed ring 22 which is connected to a positioning rack 24 (partially obscured) which is housed or protected by the body 18. The positioning rack 24 is shown in
[0033] While
[0034]
[0035] Further, it should be appreciated that the exemplary embodiment shown in
[0036] Additionally, while the exemplary injection control device is shown in
[0037]
[0038] In an exemplary embodiment of the injection control device, the gearing arrangement of
[0039] It should be appreciated that while
[0040] In one mode of operation, the ring 22 is held stationary with respect to the subject's surface being injected. The body 18 of the injection control device is moved as the cannula 12 is withdrawn. In another mode of operation, it may be desirable to advance the entire injection control device as a unit as the cannula 12 is advanced into the tissue. Then the ring 22 is held stationary with respect to the tissue as the body 18 of the injection control device with the syringe 14 and cannula 12 is withdrawn expelling the injectate in the syringe 14. The ring 22 is then pushed back into the body 18 of the injection control device. The entire injection control device is then again advanced as a unit.
[0041] In another mode of operation, the reverse effect can be accomplished, wherein by advancing the cannula 12 into the tissue, material can be sucked into the injection control device. Therefore, as will be apparent from the description provided herein, multiple modes of operations may be contemplated, accordingly, the injection control device may also operate as a suction (extraction) control device.
[0042] In view of various movements of the body 18 with respect to the ring/positioning guide 22, the positioning rack's teeth 24a will engage with the teeth 54a of the outer gear 54 of the positioning rack gear assembly 55 and cause rotation. The positioning rack gear assembly 55 may be configured with teeth ratios to act as a reduction gear in order to translate the linear displacement of the positioning rack 24 to a reduced linear displacement of the syringe rack 34. As the teeth 56a of the inner gear 56 of the positioning rack gear assembly 55 engage with the teeth 58a of the outer gear 58 of the syringe rack gear 57, the teeth 62a (not shown) of the inner gear 62 (not shown) will engage the teeth 34b of the syringe rack 34, causing a linear displacement of the syringe rack 34.
[0043] It is should be apparent from the above description concerning the operation of the ICD that the ring 22, when held against a surface, etc., operates to fix the position of the end of the ICD and also, via its fixed connection to the positioning rack 24, forms a stationary reference point for the ICD's internal mechanics to react against. That is, the now fixed position of the positioning rack 24, being acted against by the ICD internal mechanics, facilities the conversion of the translation forces of the body 18 to motion of the syringe rack 34. It should also be apparent that since the syringe 14 is fixed to the body 18, as the body 18 is being translated the syringe's cannula 12 will also translate with the body 18. Consequently, as the cannula 12 is being translated in or out of the subject, the exemplary ICD injects or extracts in synchronicity with the cannula's 12 movement. Thus, injection or extraction occurs while the cannula 12 is moving.
[0044] Regarding terminology, since the ring 22 can extend to, or in some embodiments, beyond the tip of the cannula 12, it can function as a positionable member to assist in aligning the cannula 12 to the patient or subject. Also, since the positioning rack 24 is fixed to the ring 22, the combination of the ring 22 and the positioning rack 24 operates as a reference member for the internal transmission (e.g., gearing assembly, etc.) to react against as the body 18 is translated when the ring 22/positioning rack 24 is stationary or fixed. Accordingly, it is understood the term positioning guide as used herein does not describe a member that solely operates for positioning an injection device, but a member that is extendable to a fixed location (positionable) on the subject tissue, and being fixed provides a reference point or fixture for the body and associated transmission to react. Therefore, while the term positioning guide is used throughout this disclosure, it is expressly understood that it describes a positionable transmission reference member.
[0045] In an exemplary embodiment of the injection control device, a ratio of approximately 5.2093:1 was used to effect the desired movement of the positioning rack 24 with respect to the syringe rack 34. That is, for every 5.2093 inches the injection control device is displaced or withdrawn from the tissue with the ring 22 held in place, the syringe rack 34 advances approximately 1 inch. Given a commercially available 1 cc syringe, the exemplary injection control device will inject approximately 0.00436 cubic inches of filler material for every one inch the cannula 12 is withdrawn from the tissue.
[0046] The gearing ratio described above may be adjusted according to methods and systems known in the art of gearing. Therefore, the gearing ratio may be adjusted by simply replacing the appropriate gears and racks to achieve a desired injection rate. In such embodiments, a dialing in of a different gear ratio may be contemplated, according to gearing systems known in the art. Alternatively, to achieve a different or variable injection rate, varying syringes with different bore diameters may be used, to increase or decrease the rate of material injected. If the outside diameter of the syringe is held constant while the internal diameter is varied, this will allow the effective gear ratio or injection rate to be easily varied according to the application. This can prove to be a very economical way of changing gears without changing the actual gearing of the injection control device or switching to a similar injection control device with a different gear ratio.
[0047] As is made apparent from the above description, one mode operation of the exemplary injection control device may entail the user positioning the injection control device with the ring 22 (operating as a positioning guide) against the tissue or a pre-determined distance from the tissue. With the ring 22 (positioning guide) held in a stationary position, the body 18 of the injection control device can be advanced into the tissue and then withdrawn, with the ring 22 (positioning guide) held in place. Consequently, the advancing motion of the cannula 12 will create a tract in the tissue, while the withdrawing motion of the cannula 12 (the body 18 of the injection control device) will deposit the filler injectate in the void created in the tract as the cannula 12 is withdrawn.
[0048] In order for the ring 22 to be fixed at a desired position in proximity to the surface of the tissue, the ring 22 should be allowed to be manipulated in a forward or skin-side direction without causing the syringe rack 34 to move. This freedom is achieved by a clutching mechanism that is discussed in further detail below.
[0049] It should be appreciated that, in some embodiments, it may be desirable to have the ring 22 (positioning guide) flush to the surface of the tissue, thus providing the stable reference of the body surface for the user to exert a push against while he is pulling the injection control device. Of course, it should be apparent that depending on the preferences and skills of the user, the ring 22 may not placed against the tissue or surface but at a preferred distance. For example, a user may place his thumb into the ring 22 and use the span of his hand with his fingers or palm against the surface of the tissue, resulting in the ring 22 being positioned a pre-determined distance from the surface of the tissue. Thus, it should be apparent that variations of the placement of the ring 22 as well as its shape may be practiced without departing from the spirit and scope of this disclosure.
[0050]
[0051]
[0052] As shown in
[0053] In particular, the use of a clutch 55c or one-direction-engagement mechanism enables the user to adjust the position or extension of the positioning rack 24 from the body 18, with the ring 22 at a desired distance from the tissue, without causing the syringe rack 34 to move in a reverse orientation. The clutch 55c can be engaged in such a manner to cause the gear train to rotate and advance the syringe rack 34 (or plunger) into the syringe, as the body 18 of the injection control device is moved away from the ring 22. The clutch 55c allows the body 18 of the injection control device to move towards the ring 22 without the syringe rack 34 moving with respect to the syringe. Also, the clutch 55c can be configured to prevent the gear train from moving the syringe rack 34 with respect to the syringe as the body 18 is advanced with respect to the ring 22.
[0054] In some embodiments, the clutch 55c may be supplanted with an arrangement wherein the teeth 54a of the outer gear 54 are displaced from the teeth 24a of the positioning rack 24, by some switch or motion (not shown) that is coupled to the positioning rack gear assembly 55. Thus, by removing contact of the teeth 54a of the outer gear 54 from the teeth 24a of the positioning rack 24, the positioning rack 24 may be moved without causing the syringe rack 34 to move.
[0055] It should be appreciated that one of ordinary skill in the art of gearing may devise an alternative scheme for providing free movement of the positioning rack 24 in a preferred direction, or even in both directions. The above clutching mechanism 55c is provided as one simple scheme for achieving the desired results wherein more complicated or different schemes may be contemplated. Therefore, other schemes or systems for providing controlled motion or contactless motion may be used, whether using gears, clutches, slips, discs, springs, etc., without departing from the spirit and scope of this disclosure.
[0056]
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[0058] The syringe rack 34 is also shown in
[0059] It should be noted that in
[0060]
[0061] By use of the exemplary injection control device several advantages can be obtained: [0062] The injection of the injectate is substantially proportional to the length of the injection tract and uniform along the course of the injection tract; [0063] An automatic controlled injection system can be used for injection; [0064] A fixed amount of injectate can be injected per unit distance traveled by the tip of the cannula; [0065] The injection ratio (amount of material injected over a given distance of cannula withdrawal) can be varied by simply using varying bore diameter syringes; [0066] The use of syringes (disposable); and [0067] The use of syringes incorporating a rack in the plunger.
[0068] It should be appreciated that based on an understanding of the exemplary injection control device disclosed herein, several modifications may be contemplated without departing from the spirit and scope of this disclosure. As some cannulas may be of different diameters and openings, a volume approach may be achieved by adjusting the gearing, for example.
[0069] As another modification, the clutch 55c may be configured to operate in a reverse manner than described. That is, rather than having the exemplary injection control device inject filler material, the exemplary injection control device may be configured to suck material. Thus, in some applications, harvesting material may be accomplished by altering the clutching or gearing of the exemplary injection control device.
[0070] Along the lines of the above modification, it is possible to design a gearing system that injects material as the cannula is advanced, rather than withdrawn. Additionally, the exemplary injection control device may be configured with opposing gear trains that would enable the injection of filler material as the cannula is advanced as well as when the cannula is withdrawn. Similarly, the exemplary injection control device may operate in a manner to enable the withdrawal or sucking of material as the cannula is advanced as well as when the cannula is withdrawn.
[0071] Several other variations of the exemplary injection control device described above are detailed below.
[0072]
[0073] Thus, with the clutch is engaged, worm gear 85 rotates with spooling mechanism 84 as the removed body is translated with respect to rackless positioning guide 82. Spooling mechanism 84 will unwind, turning worm gear 85 which turns main gear 89, which engages teeth 87a of plunger rack 87 to drive or retract the stopper (not shown) in the syringe 14. Plunger rack 87 may be supported by a single bearing 88. When the clutch is not engaged, spooling mechanism 84 may rotate without causing rotation of worm gear 85. It is noted it is possible that the resistance of the stopper in syringe 14 will operate to obviate the need for a second clutch to prevent movement of the plunger rack 87 during preliminary setup of the ICD.
[0074] Spooling mechanism 84 may be a drum with a coil or a constant force spring, for example. Coil portion (end of) the constant force spring can be attached to the forward or aft section of rackless positioning guide 82, depending on the mode of operation. The constant force spring provides tension on the coil to allow it to wind properly. Further, if enough tension is provided, the winding force may be sufficient to assist in driving (or withdrawingdepending on mode of operation) the plunger rack 87 back to its starting position. For injection/extraction materials that are particularly viscous or thick, the implementation of an assistive device (such as the constant force spring) can be beneficial. It is envisioned, in some embodiments the positioning guide 82 may start in the extended position and via insertion of the cannula 12 into the tissue, the insertion force operates to push the positioning guide 82 into the retracted position and loads the constant force spring, which in turn provides the motive force to drive the gear train, as the positioning guide 82 is allowed to push the body of the ICD away from the tissue being injected. Accordingly, a constant force spring or spring motor could be loaded by a winding mechanism to store energy that could be used to assist in the injection.
[0075]
[0076] It is worthy to note in passing that similar to
[0077]
[0078] The adjustable stops 112, 114 can be a pin that is inserted in multiple accommodating holes (not shown) along the body/positioning guide or a sliding lock as seen in disposable box cutters. Of course, other forms or mechanisms for locking or restricting the range of motion may be used and are understood to be within the purview of one of ordinary skill.
[0079] Also evident in this FIG. is that, for this example, the front 93a of positioning guide 92 has been designed with a substantially flat surface, thus conceivably acting as a depth gaugepreventing insertion of the cannula 12 past a certain point on the cannula 12. In regard to gauges, this or other exemplary ICDs may have a gauge (not shown) external or visible on the body 118, to allow the user to view the amount of material in the syringe 14. In some embodiments, the body 118 may have an opening (not shown) that allows viewing of the syringe 14. To this end, body 118 does not completely encase syringe 14, as in the first embodiment. Rather the bulk of the syringe 14 is exposed, which allows for the user the ability to visually inspect the syringe's contents, before and after administration. As in previous embodiments body 118 is configured with optional finger rests 119.
[0080]
[0081]
[0082] It should be noted, that as a design choice valve 135 is considered a one-way valve or unidirectional valve, for ease of operation. However, it may be possible to have switchable bi-directional valve. That is, in a less elegant design, the injection operation of the ICD would have a switchable bi-directional valves in an injection-mode configuration (e.g., valve 135 closed to prevent injectate from flowing out of valve 135), via a switch or lever or button on the valve. And when in refill-mode operation, valve 135 would be flipped over to the opposite flow (e.g., valve 135 opened to allow injectate flow into the pistoned chamber 139).
[0083] In another design choice, cannula-side end 134 may be replaced or added to with an output valve that provides one-way or unidirectional flow of the injectate into the subject tissue (i.e., meat) whilst preventing return flow of air via the cannula (not shown) when the pistoned chamber 139 is being refilled via intake valve 125. This option is for situations where the cannula is of a large diameter and air would easily be sucked into the pistoned chamber 139, negating the drawing of the refill injectate. As in the previous discussion, the output valve may also be a switchable bi-directional valve.
[0084] The ICD transmission movement mechanics of this design are similar to one or more of the previous designs, however, the barrel of the syringe contains the large pistoned chamber 139 and principal flow and refilling is controlled intake valve 135. The pistoned chamber 139 can be considered a reservoir for the injectate that is supplied from an external larger source.
[0085]
[0086]
[0102] It should be appreciated that some of the elements described in
[0103]
[0115] As stated above, some of the elements described in
[0116] It should be appreciated that based on an understanding of various embodiments of the injection control device disclosed herein, several modifications may be contemplated without departing from the spirit and scope of this disclosure. As some cannulas may be of different diameters and openings, a volume approach may be achieved by adjusting the gearing, for example.
[0117] As one possible example, the valves described above may be of a disposable, limited use form, being able to be switched out without much effort, if so needed. Also, the intake valve may be positioned away from the body of the syringe such that there is feed line between the valve and the intake to the syringe. The valve would have an intake feed line from the reservoir of the injectate. So, the intake feed line may be connected to an intake that does not have an incorporated unidirectional valve. The valve may be positioned more upstream in a break in the feed line. Upstream can mean closer to the reservoir containing the injectate. The purpose of this modification would be to accommodate a larger unidirectional valve that is less prone to clogging when injecting fluids that are more viscous or contain significant amounts of particulate matter. As a larger unidirectional valve positioned close to the syringe intake may make the device awkward to maneuver close to the meat. Also, it is conceivable of using a pressurized reservoir to assist pushing the injectate through the tubing to the syringe. This approach also suggests a separate pumping system may be added to provide the pressure, as needed. In other possible embodiments, the pistoned chamber may not utilize a piston, so to speak, but another form of liquid-providing pressure. Non-limiting examples may be a rotating screw in the chamber pushing the injectate forward, a moving ball, etc. and etc. Thus, other forms of moving the injectate can be utilized, according to design preference.
[0118] In various applications, it is envisioned that using a cylindrical cannula will result in cylindrical tracks of material left in the channel created by the cannula's intrusion. Using computer/automated devices, an increased degree of control can be obtained in the amount and shape of the deposited material or extracted material as well as variation of the injection/extraction profile. For example, conical, elongated spheres, or series of spheres could be produced. A similar result can also be obtained by using a camming system in the transmission system to periodically delay/increase the rate of injection/extraction. Following this, a robotic system which precisely controls the position and rate of motion of the cannula and/or rate of injection/extraction could be implemented in the ICD. Moreover, while the applications are in the context of a cannula inside a subject, the ICD can be easily adapted to regulate the rate of extrusion of a fluid for a topical application.
[0119] It will be understood that many additional changes in the details, materials, steps and arrangement of parts, which have been herein described and illustrated to explain the nature of the disclosure, may be made by those skilled in the art within the principle and scope of the disclosure as expressed in the appended claims.