The present invention relates to a new type of dental syringe system, including a novel needle assembly
In the dental syringe art, the conventional syringe is adapted to allow the dentist to retract the syringe plunger after the initial stick, in order to ascertain that he has not hit a blood vessel, by using his thumb in the thumb ring of the syringe, pulling back on the plunger and observing the anesthetic vial to determine if blood has been pulled into the syringe. If it has, this indicates that he must find a new spot for the injection point in order to avoid injecting anesthetic into the bloodstream via a blood vessel. There are two reasons for this:
1. The anesthetic usually contains epinephrine, which can affect heart rate adversely.
2. If the anesthetic is taken away from the site by the blood vessel, it will fail to anaesthetize the site.
Thus, in contrast to the usual medical syringe used by doctors, in which the entire syringe is generally disposable, the dental syringe has a reusable metal framework. Medication is usually in a disposable cartridge. So this type of syringe is also known as a cartridge syringe.
The closest reference we are aware of in the art is the Present Inventor's earlier patent:
The present invention improves on the disclosure of said present inventor's prior patent.
U.S. Pat. No. 6,764,471 B2 is hereby incorporated by reference.
Other References:
Hospira™ (part of Abbott Labs™) has Carpuject™ syringes.
See: http://en.wikipedia.org/wiki/Carpuject
https://www.youtube.com/watch?v=r4a9E4oV6jY
The present invention provides a sheath, which snaps or screws on to threads on the needle-end, or tip, of the syringe to stabilize the needle during injection. This sheath will be made out of either plastic or metal and clipped onto the syringe.
This sheath will allow the insertion of a needle assembly, in the sheath's resting position.
We will define axial directions used in this application as:
After insertion of the needle, this sheath will be rotated to push the needle assembly tip-ward, thereby seating a conical segment of the needle assembly, against a cooperatively shaped conical part of the interior of the syringe body's tip-ward end.
The sheath will thus stabilize the needle, and thereby facilitate changing anesthetic cartridges during multiple injections.
Further rotation of the sheath will cause the flexible sheath to jump the threads on the syringe and thereby relieve the seating pressure and allow the needle to fall from the syringe into a sharps container.
Alternatively, reversing rotation of the sheath will also relieve the seating pressure and allow the needle to fall from the syringe into a sharps container.
The prior art requires a user to:
aspirate the medications from the vials and ampules into the medical grade disposable (plastic) syringes, which typically use a large bore needles (20 or 22 gauge); and then inject the medications into a person,
The present invention can deliver the medications using the smaller bore needles, if the medications are placed into the cartridge form.
The system, when assembled, forms an assembly which is generally designated 3.
A syringe 5 comprises a thumb ring 7, and a finger grip 8, on a syringe body 9.
I will hereinafter describe and claim the thumb ring 7 as an actuator ring 7, to avoid claiming a human body part, the thumb.
Shaft 10 slidably mounts actuator ring 7 to syringe body 9. At the tip-ward end of shaft 10 is a harpoon 11.
A medicine cartridge 12 is mountable in syringe body 9 of syringe 5. This facilitates use of a narrower gage needle such as 27-gage. Medicine cartridge 12 has a slidable seal 13, into which harpoon 11 can be inserted and anchored to form a plunger (13, 11, 10, & 7) with shaft 10, which can then be slid: tip-ward; or ring-ward; by manipulating the actuator ring 7 in those directions. The ring-ward direction will be referred to in the claims as a ring-ward direction. The actuator ring 7 is configured to be controlled by a thumb, controlling the actuator ring 7 ring-ward to expand or tip-ward contract the volume of the cartridge.
Finger grip 8 comprises a recess 17, and a pair of flanges axial to the recess 17:
But before harpoon 11 is inserted into the cartridge, needle assembly 14 is placed with a conical portion 15, of needle assembly 14, seated inside the matching conical end 16 of syringe body 9. A removable sheath 20 is configured to retain the needle assembly 14 in the syringe body 9.
The syringe body 9 has an external spiral mount 40 on the cylindrical portion of syringe body 9. The external spiral mount 40 includes a threaded matching groove or thread on the outside of the cylindrical portion of syringe body 9.
The sheath 20 and its internal thread 50 may be rotated in a loosening direction, which would be counter-clockwise when viewed from the tip-ward end. This clockwise rotation causes the tip-ward end 21 of sheath 20 to push against flange 22 on a cylindrical portion 27 of needle assembly 14, and thereby seat conical portion 15 of needle assembly 14 firmly against matching internal, conical end 16 of syringe body 9.
Sheath 20 will be made of a plastic which has a melting temperature above 137 degrees Celsius so that the sheath 20 may be autoclaved. The sheath plastic should also be somewhat elastic (to allow insertion and removal from the syringe), and relatively cheap and easy to manufacture. The presently preferred plastic is nylon. The sheaths 20 are disposable (after multiple uses). New sheaths can be bought separately.
Needle 31 has a point 34.
We define the longitudinal axis 31A for all parts of this application as the axis along which needle 31 is intended to be located when in place.
Syringe body 9 comprises a spiral groove or grooves 39, in a grooved part 40 of syringe body 9. The groove is preferably on a cylindrical part of an outside surface of the syringe body 9. The groove is spiral.
In
In the photos that were FIGS. 2 & 19 of the Provisional Application 62/118,310, a non-functional piece of paper was placed against the back-wall so the front walls 102L & 102R and gap 64 could be seen in
A protruding thread 50, matches the groove 39 (
As on
is interrupted at gap 43,
continues at segment 52 continuously around the back-wall 42B as segment 53,
continues continuously as segment 54 around inside the front-wall 42L,
is interrupted at gap 43,
continues at segment 55 continuously inside the front-wall 42R, continuously around the back-wall 42B as segment 56,
continues continuously as segment 57 around inside the front-wall 42L, and
segment 57 ends at the gap at 44, the tip-ward end of thread 50.
Sheath 20 should be installed on syringe 5 syringe body 9, first. This can be done by:
Thread segment 51 rides over land 117, to snap into groove 94 while thread segment 52 rides over land 115, to snap into groove 92.
A further push on tip 107 causes:
thread segment 51 to ride over land 114, to snap into groove 91, while thread segment 52 rides over land 115, to snap into groove 92; while thread segment 54 rides over land 117, to snap into groove 94, while thread segment 55 rides over land 115, to snap into groove 92.
Sheath 20 is now positioned as shown in
This sheath 20 will allow the insertion of a needle assembly 14, in the sheath 20's resting position, shown in
In
To remove a needle assembly 14, reversing rotation of the sheath 20 will relieve the seating pressure and allow the needle assembly 14 to fall directly from the syringe into a sharps container by inverting the syringe (over the sharps container).
At this point it's useful to fully describe and show the details of the presently preferred sheath 20.
Smaller stop 152 is seen through the translucent wall of sheath 20, as are thread segments 52, 53, and 56.
Because surface 157 approaches surface 16, the rotation becomes stiffer, until stop 151 (
At
Increasing rotation force will force the sheath 20 to rotate again and accelerate briefly, as stop 152 (
But, there is only about one millimeter of play before stop 151 stops hard against edge 160 (
After insertion of the cone 15, this sheath 20 will be rotated 180 degrees so that the incline of thread 50 and grooves 39 push the needle assembly 14 tip-ward, to the position shown in
Sheath 20 will thus stabilize the needle assembly 14, and thereby facilitate installation of anesthetic medicine cartridges 12, and facilitate changing anesthetic medicine cartridges 12 during multiple injections.
Further tightening rotation of the sheath 20 will cause the flexible sheath's threads to jump the grooves on the syringe, allowing sheath 20 to move one groove ring-ward, and thereby relieve the seating pressure, and thereby allowing the needle assembly 14 to fall from the syringe 5 into a sharps container, not shown.
Alternatively, reversing rotation, to a loosening rotation of sheath 20, will relieve the seating pressure and allow the needle to fall from the syringe into a sharps container.
This sheath 20 can be made out of stainless steel sheet to meet the above criteria. The stainless steel sheet can remove the chrome plating after multiple uses; therefore, there must be no sharp edges to remove chrome plating.
Dimensions are provided in millimeters (mm). Body 9 has a tip-ward surface 225 measuring 5.2 mm across its outer diameter. Threads 227 at the bottom or ring-ward end of syringe body 9 can screw into finger grip 8 (
A 24.8 mm long slot 278 is provided, so that the user can change medicine cartridge 12 by:
The original informal
A collar 228 extends tip-ward from the syringe body 9. The collar 228 has a tip-ward edge 225.
A front collar opening 226 has a width 226A equal to the inner diameter of the collar 228. The front collar opening width 226 extends the axial length 226B of the collar 228.
The opposite end of needle tube 14A is a second needle or cartridge needle 231 in fluid communication through needle tube 14A with needle 31, at the ring-ward end of needle assembly 14, under protective cap 238, when assembled.
Cartridge needle 231 is exposed, when uncapped, so that it may impale a diaphragm 301, atop cap 303 at a tip-ward end of medicine cartridge 12, establishing fluid communication from the medicine cartridge to the hollow needle tube 14A.
Needle tube molded body 14B reinforces needle 31. Self-aspirating cylinder 240 reinforces the needle tube 14A at its cartridge-ward end. Self-aspirating cylinder 240 creates a self-aspirating effect when pressure on the actuator ring is relaxed, by allowing the cartridge diaphragm to relax and expand the cartridge interior volume to reduce atmospheric pressure within the cartridge, and suck back some blood, into the cartridge, if the needle 31 tip 34 is in a blood vessel.
Cone 15 is tip-ward of self-aspirating cylinder 240.
A second cylinder 244 is tip-ward of cone 15. This cylindrical form, second cylinder 244 carries tip-ward to the flange 22. Flange 22 is provided, for sheath 20's pushing against, as in
Domed cylinder 248 reinforces needle 31 tip-ward to domed cylinder 248's tip-ward end, past which, needle 31 is bare.
When ring-ward cap 238 is in its protective position:
From tip-ward, in a plan view, the six fins 251 resemble an asterisk.
To install the needle assembly 14 onto the syringe, sheath 20 is snapped onto syringe body 9, as in
Ring-ward protective cap 238 is removed from lower or ring-ward needle 231 to expose ring-ward cartridge needle 231. The needle assembly 14 is placed with its cone 15 through the aligned front openings of syringe and sheath, with conical portion 15 of the needle assembly 14. Conical portion 15 is then seated inside the matching conical end 16 of syringe body 9, as in
Sheath 20 is then rotated in a clockwise direction, when viewed from the actuator ring 7, to be positioned as in
Thumb ring 7 (
Through the front opening 280 of compartment 270 (
Thumb ring 7 is then pressed by the user, tip-ward towards the needle;
driving shaft 10 and harpoon 11 into slidable seal 13 (
driving the medicine cartridge 12 toward the needle assembly 14; and
impaling the tip-ward diaphragm 301, located in cap 330 of the medicine cartridge 12, by impaling the tip-ward diaphragm 301 on cartridge needle 231 of
creating fluid communication between the medicine in medicine cartridge 12 and the hollow needle 31 and its hollow point 311 at tip 34.
Medicine cartridge 12 may thereafter be changed for this patient. Thumb ring 7 is withdrawn as far as possible which pulls harpoon 11 out of slidable seal 13 and provides clearance of the cartridge, probably disengaging the cartridge from cartridge needle 231.
If the cartridge 12 as not come loose of harpoon 11, the cartridge is grasped between a thumb (through opening 280) and forefinger (through opening 278), and pulled tip-ward from harpoon 11.
Syringe 5 can then be turned front side down. Medicine cartridge 21 will then fall through opening 280 out of compartment 270.
A new medicine cartridge 12 may then be inserted as described above.
When the patient is done being anesthetized, the last cartridge can be removed, sheath 20 can be rotated in either direction, which will either:
Either way, the pressure holding the flange 22 tip-ward, and holding cone 15 in its seat 16, is relieved. Then the syringe can be turned, front-down, allowing the needle assembly 14 to drop out of the syringe 5 into a sharps container.
The Slope of the Grooves.
The limitation of the activation position will be when the sheath 20 pushes the needle assembly 14 against the end of the syringe 5. But the slope of the grooves has to be such that, for a 120-degree rotation, the forward, or tip-ward, traveling length (from the resting to the activated position) is about 1.8-2.0 mm.
Sharps De-Tipping System
New matter in the United States Bypass Continuation-in part application follows. The new matter comprises a system of removing the needle 31 from the syringe 3.
Atop to the sharps container bottom portion 404 is removably attached a sharps container in top 410. This conventionally includes a sharp container lid 412.
Sharps socket 414 is a novel part of this sharps container 400.
Sharps socket 414 has a front opening 418.
A left notch 420 and a right notch 422 in the opening 418 of socket 414 are configured to engage exterior ribs 141 & 142, said ribs for facilitating finger grip on the outside of sheath 20, shown in
As shown in
In
The front 42 of sheath 20 is closed at gaps at 43, 44 (
In
Had syringe body 5 been rotated counterclockwise, the counterclockwise rotation would unscrew the internal threads 52-58 of the sheath 20 from the grooves 91-95 of the syringe body 9 (see
In
Therefore, in
Socket 414 is preferably made of polypropylene, as is the sharps container 400. Snap-in fasteners 438 may protrude from the container-side of the socket 414. The snap-in fasteners 438 will snap into cooperatively sized fastener holes 439 in the sharps container top 410.
Socket 414 comprises a socket bottom opening 441 (
In
The sheath (20) is mounted rotatably to the syringe body (9). The sheath has a sheath gap (33) extending the length of the sheath, said sheath (20) having a sheath exterior surface 446, and a pair of ribs 142L and 142R protruding from the sheath exterior surface 446. Said ribs 142L and 142R are aligned in a direction parallel to the longitudinal axis 31A of the sheath 20, which axis coincides with the needle 31.
The socket (414) has a socket interior surface 442 which is selectively shaped to fit snugly and removably to the sheath exterior surface 446. The socket interior surface 442 has:
The socket (414) comprises a socket bottom opening (441).
Said socket having a socket front opening (418).
Said front opening (418) is open to the socket interior surface (426).
The socket interior surface 442 comprises a longitudinal notch extended through the socket front opening (418) of the socket (414);
A pair of these longitudinal notches 420 & 422 are on the ring-ward socket cylindrical segment 445, of the socket interior surface 442. The longitudinal notches 420 & 422 are: aligned in a direction parallel to the longitudinal axis 31A of the socket 414, and placed so that the ribs 142L and 142R align with these longitudinal notches 420 & 422, and slide into said notches 420 & 422, when the needle assembly 14 is inserted through the socket front opening 418 of the socket 414, to fit snugly into the socket 414 interior surface 442. Said notches 420 & 422 hold the ribs 142L and 142R thereby keeping the sheath and socket aligned with socket bottom opening 441 aligned with the sheath opening 43 as syringe 5 is rotated.
When the syringe body 5 is rotated to the alignment depicted in
Alternate Needle Assembly Embodiment
Sheath 20 has: a tip-ward cylindrical section 477, section a central conical section 478, and a ringward conical section 479.
In
Shown in
In
The ring-ward circumferential edge 510 of molded body 14B is at ring-ward plane 500.
The ring-ward circumferential edge 510 is annular in shape, and has at its widest part 631 an outer diameter 631 of 7.1 mm and an inner diameter of 6.1 mm, giving a wall thickness of 0.5 mm.
A standard dental medicine cartridge 12 has an endcap 303 (
To install the needle assembly 14 into the syringe, conical part 15 of needle assembly 14 has been firmly located against the cone inside 140 of syringe cone 16, by the pressure of tip-ward surface 107 (
Then the larger 7.9 mm diameter 630 abuts and covers the smaller 7.1 mm outer diameter of 631 of ringward edge 510. This abutment thus supports the cartridge 12, under tip-ward pressure of actuator ring 7 through the plunger (7, 10, 11, 13).
In manufacturing the needle 14A to molded body 14B, a glue, such as epoxy, is applied to the outside of a tip-ward part (31) hereinafter tip-ward needle (31) of needle 14A, where the tip-ward needle 31 is to be placed inside the tip ward end within domed cylinder 248 of molded body 14B, within needle shaft 514 of molded body 14B. Thus, when the needle 31 is inserted into needle shaft 514, and it has reached its intended axial location, then the needle is held in position until the glue sets, and the glue holds the needle affixed to the shaft within domed cylinder 248. The tip-ward needle 31 becomes affixed inside molded body 14 at domed cylinder 248.
But at the other (ring-ward) end of needle 14B, the ringward cartridge needle 531 fits loosely in inside needle shaft 514. The shaft 514 passes through the center of rib core 504 at the ringward end of cone 15 (
Unlike
The inventor prefers to use a 27-gage needle 31, because his experience has shown the patients experience less pain than with a larger gage needle such as a 25 gage. The use of medicine cartridges allows use of a smaller gage needle, than would be optimum if medication needed to be drawn into the syringe via the needle 31.
Harpoon 11 (
by manipulating the actuator ring 7 in those directions.
The actuator ring 7 is thus configured to be controlled by the dentist's or a user's 430 thumb, controlling the actuator ring 7 to expand or contract the volume of the cartridge.
The dentist retracts the syringe plunger after the initial stick, in order to ascertain that the point at tip 34 or 311 is not within a blood vessel, by:
If red blood has been pulled into the cartridge 12, the red visible within the cartridge cylinder 12 indicates that the dentist must find a new spot for the injection point, in order to avoid injecting anesthetic into the bloodstream via a blood vessel.
The needle assembly includes ringward plane 500 of the needle assembly 14.
Unlike in
Therefore, there is no self-aspirating effect when pressure on the actuator ring is merely relaxed.
Therefore, the harpoon 11 (
The needle assembly 14, without the self-aspirating cylinder 240 (
The needle assembly 14 is sterilized and assembled with the sterile protective caps 38 & 238. Protective cap 38 protects needle 31, to prevent needle 31 from stabbing a user accidentally.
Cartridge protective cap 238 protects cartridge needle 231, to prevent cartridge needle 231 from stabbing a user accidentally.
The protective cap 38 has a ring-ward edge 39. Ring-ward edge 39 abuts needle flange 22.
The protective cap 38 has a ring-ward cylindrical cap segment 700. The ring-ward cylindrical cap 38 segment 700 has an inside surface 705, sized to friction-fit the outer radius of fins 251.
The protective cap 38 has a center cylindrical cap segment 710 larger than the ring-ward cylindrical cap segment 700. The center cylindrical cap segment 710 forms an annular shoulder 714, against which a cartridge needle cap tip-ward edge 239, of the cartridge needle protective cap 238 abuts.
Cartridge needle protective cap 238 has a tip-ward cylindrical segment 726.
Tip-ward cylindrical segment 726 has an inner surface 727 which is friction-fit to an outer surface 730 of tip-ward cylindrical segment 726, to hold cartridge needle protective cap 238 in place.
Ring-ward cartridge needle protective cap segment 738 is narrower than tip-ward cylindrical segment 726, so that the inner surfaces form a cartridge needle protective cap shoulder 740. Cartridge needle protective cap shoulder 740 abuts needle assembly flange 22 to stabilize the cartridge needle protective cap 238.
Cartridge needle protective cap 238's tip-ward cylindrical segment 726 has an inner surface 738.
Cartridge needle protective cap's 238 ring-ward cylindrical segment 738's inner surface 739 is a friction fit with ring-ward end segment widest part 631 of needle assembly 14.
The strip of paper 747 is distinctively printed 777 to facilitate authentication, and to provide a further visual indicator of past use, because the torn-in-two printed halves of the paper strip are unlikely to match up if the caps are replaced simply to protect against needle sticks from within the trash bags.
The printed strip 747 is seen in the photo that comprised informal
This application is a Continuation-in-Part Application taking priority and benefit of all common subject matter of: U.S. Continuation-in-Part Ser. No. 15/688,621 filed 29 Aug. 2017;U.S. Bypass Continuation-in-Part application Ser. No. 15/552,493, filed 21 Aug. 2017; PCT/US16/18587 filed 19 Feb. 2016; andU.S. Provisional Patent Application 62/118,310 filed 19 Feb. 2015; all of which applications are incorporated in this application by reference; and the Inventor's U.S. Pat. No. 6,764,471 B2 Granted: Jul. 20, 2004, on application number: U.S. Ser. No. 10/008,373 is hereby incorporated by reference
Number | Name | Date | Kind |
---|---|---|---|
1012700 | Payne | Dec 1910 | A |
1532744 | Hein | Apr 1924 | A |
2147616 | Chaput | Feb 1939 | A |
2169371 | Payne | Aug 1939 | A |
2956563 | Sarnoff | Oct 1960 | A |
3848593 | Baldwin | Nov 1974 | A |
4892525 | Hermann, Jr. | Jan 1990 | A |
4931040 | Haber | Jun 1990 | A |
5069225 | Okamura | Dec 1991 | A |
5205827 | Novacek | Apr 1993 | A |
5501670 | Sak | Mar 1996 | A |
6764471 | Lee | Jul 2004 | B2 |
8128605 | Masi et al. | Mar 2012 | B2 |
20020004647 | Leong | Jan 2002 | A1 |
20110068034 | Hwang et al. | Mar 2011 | A1 |
Number | Date | Country |
---|---|---|
0 441 628 | Aug 1991 | EP |
2 496 858 | May 2013 | GB |
Entry |
---|
International Search Report in PCT/US16/18587, dated Apr. 29, 2016. |
European Office Action in EP 16753107.8-1122, dated Feb. 12, 2019. |
By Wilburia Q. Lindh, Marilyn Pooler, Carol D. Iamparo, Barbara M. Dahl; Combination Disposable/Nondisposable Cartridge Injection Systems; 5th ed., 2014, p. 792, Fig. 24-10, “The Carpuject is a type of cartridge-injection system with a click-lock mechanism for safety.” book: Delmar's Clinical Medical Assisting, isbn=1133603408, Publisher: Delmar, Steven Helba, Clifton Park, NY, US, 2013. |
YAGME12, Carpuject, https://www.youtube.com/watch?v=ICJYr-0VIrA YouTube video, & Screen-grabs from said video, publisher: yagme12, Published on Apr 1, 2014, city and/or country where published: unknown. |
Photo of three Carpuject metal syringes, assembled to screw-on needles. Standardized medicine vials are to be inserted into the syringe bodies. The syringes or similar designs may date to the 1950s. |
Carpuject, From Wikipedia, https://en.wikipedia.org/wiki/Carpuject, The Carpuject is a syringe for the administration of injectable fluid. It was patented by the Sterling Drug Company, which became the Sterling Winthrop, after World War II. The Carpuject competed with the Tubex injection system developed by Wyeth. Redesigned several times. In 1988 Kodak purchased Winthrop Labs. 1994 sold to Sanofi, a French pharmaceutical company, now Sanofi Aventis. In 1997 Sanofi sold to Abbott Laboratories. 2004 Abbott separated its hospital supply line: Hospira, May 30, 2017. |
Tubex, The Tubex Syringe cartridge developed c. 1943 during World War II by the WYETH company. It is a drug pre-filled glass cartridge syringe with attached sterile needle, which is inserted in a reusable stainless steel holder (now plastic). https://en.wikipedia.org/wiki/Tubex_(syringe_cartridge). |
Number | Date | Country | |
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20180099096 A1 | Apr 2018 | US |
Number | Date | Country | |
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62118310 | Feb 2015 | US |
Number | Date | Country | |
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Parent | 15688621 | Aug 2017 | US |
Child | 15785442 | US | |
Parent | 15552493 | Aug 2017 | US |
Child | 15688621 | US | |
Parent | PCT/US2016/018587 | Feb 2016 | US |
Child | 15552493 | US |