Patent Application
20230248915
Local anesthetics are the safest and most effective drugs in medicine for the prevention and management of pain.
Among the more commonly used local anesthetics is the amide local anesthetic, lidocaine, which is suitable for infiltration, block, and surface anesthesia. In dental medicine, lidocaine, or its hydrochloride salt, is used as a pre-mixed solution with epinephrine. Whether used alone or mixed with epinephrine, lidocaine and its salt solutions are generally acidic.
Buffering or alkalinization of local anesthetics has long been reported in the scientific literature as improving onset time and making the injection of a local anesthetics less painful and more comfortable to the patient. The terms “anesthetics buffering”, “alkalinization” and “pH buffering” are recognized medical terms used for neutralizing the acidity of local anesthetics to physiological pH (7.4) before injection. Bicarbonate solution, such as sodium bicarbonate (NaHCO3) in water, is routinely used to buffer the pH of local anesthetics. However, bicarbonates cannot be premixed with lidocaine due to instability of the combination over time.
Mixing devices for pre-mixing anesthetic and buffer solutions remotely (away from the patient), and immediately prior to administration, are known and in common use. However, these conventional methods and devices for buffering or alkalinizing local anesthetics still have disadvantages:
Technological advances have failed to address these problems and provide efficient means for mixing anesthetic and buffer immediately prior to or concomitantly with administration in a practical and easy-to-use manner in a clinical setting. For example, modifications and improvements have been made to conventional syringes to control the pH of the local anesthetic solution as it is administered.
Mixing syringes for mixing two fluids such as a local anesthetic and a buffering agent within the syringe barrel immediately before administration have been described. These are configured to provide separate, axially aligned chambers “stacked” one on top of the other within the syringe barrel or, alternatively, are configured such that the chambers are configured parallel to one another, or “side-by-side,” within the syringe barrel. The vast majority of these devices relate to open lumen syringe barrels that cannot receive a prefabricated carpule of drug and diluent, i.e., they are not “cartridge” syringes or “carpule” syringes, as these terms are recognized and known in the art. More recently, U.S. Pat. No. 10,420,888 describes a side-by-side dual-barrel cartridge syringe for receiving two single carpules or one dual carpule. However, these prior attempts have been unable to resolve the problems in a cost-efficient manner.
What is needed is a dispensing device and method which can overcome these known disadvantages and deficiencies.
The subject invention concerns a partitioned carpule for use in a system and method for dispensing or administering a mixture of drug solution and diluent buffer solution from a single carpule of conventional size and shape placed within a “cartridge syringe.” A cartridge syringe is sometimes synonymously termed a “carpule syringe.” A cartridge syringe is a specialty syringe well known in the art and comprises a syringe housing, typically metal, having an opening or window capable of receiving a carpule or cartridge containing drug or diluent, or both. More specifically, the subject invention relates to a partitioned carpule for use in an aspirating cartridge syringe. An aspirating syringe comprises a harpoon at a proximal end of its plunger stem to engage with and manipulate a cap slidingly disposed in the distal end of the carpule. A stationary end cap is disposed in a proximal end of the carpule, wherein the distal and proximal end caps retain the contents of the carpule therein.
All references to a “syringe” used herein, refer to an aspiration cartridge syringe for use with a single carpule.
For purposes of the subject invention, the terms “distal” or “superior” and “proximal” and “inferior” are used to describe the relative position of the components of the syringe or system. “Distal” or “superior” refers to the end farthest away from the patient when the syringe is used, i.e., the end from which the user of the syringe actuates the plunger; “proximal” or “inferior” refers to the end closest to the patient when in use, i.e., the end of the syringe engaged with a hypodermic needle.
The terms “axial,” “longitudinal,” or “longitudinal axis,” or “axial length” all refer to a relative position or direction along one or more long axis or length dimension of the generally cylindrical syringe and carpule of the invention.
A standard cartridge syringe used in the medical or dental fields comprises a cylindrical barrel, typically formed of a metal, wherein the barrel has an opening or window in a side wall for receiving and removing a single carpule containing drug or diluent. At its distal end, the barrel of the standard syringe can comprise a flange or flanges forming a fingerhold to facilitate actuation of a plunger for expelling the contents from the barrel or a carpule contained within the barrel.
The cartridge syringe comprises a plunger which includes a piston or stem portion which slidingly engages the barrel at the flanged end of the barrel and, at its distal end, can comprise a thumbpiece—typically a flange or ring—for placement of a user's thumb and actuation of the plunger by a pushing motion which slidingly pushes the distal end cap of the carpule toward the proximal end of the carpule to expel the contents therefrom. In an aspiration syringe, the harpoon engages the distal end cap of the carpule such that a pulling motion on the fingerhold can actuate the plunger in an opposite direction, allowing the distal end cap of the carpule to be drawn or pulled back toward its original distal position.
A standard aspiration cartridge syringe also includes a delivery port at its proximal end and comprises a hub capable of engaging a removable hypodermic transfer needle.
In one embodiment of the invention, a syringe and system according to the subject invention comprises the above features, but can differ in its plunger configuration, by the carpule used, and by inclusion of a mixing chamber. For example, the subject invention can include a syringe having a modified plunger wherein the plunger stem or piston is divided or split along part of its length, or longitudinal axis, and therefore comprises a slot from its proximal end, effectively forming dual stems, each of which engage with corresponding end caps in an axially partitioned carpule. The slot can run the entire length of the stem up to the plunger flange at its distal end or can run a portion of its length, wherein the slotted stem is adjoined at its proximal end and adjoins the plunger flange as a single, unslotted stem. The adjoined section can be from 1-25 mm in length and is determined by the length of the slot, which should be capable of traversing the length of the carpule to completely expel the contents thereof.
An axially partitioned carpule is also part of the subject invention. Preferably, an axially partitioned carpule comprises an asymmetrically disposed partition, i.e., disposed off-center from the longitudinal midline, forming two asymmetric longitudinal reservoirs within the chamber of the carpule—one reservoir having a smaller volume and the other reservoir having a larger volume relative to one another. The smaller reservoir typically contains anesthetic solution, and the larger reservoir typically contains diluent or buffer solution.
To further facilitate mixing of the contents of a partitioned carpule, a syringe of the subject invention can comprise a mixing chamber positioned between the syringe barrel and the delivery port. The mixing chamber can include a wall that separates the mixing chamber from the syringe barrel, but in such configuration will include a piercing needle for traversing the proximal end cap of a partitioned carpule to allow fluid communication between the carpule and the mixing chamber.
In an embodiment of the invention which employs a longitudinally partitioned carpule having two proximal end caps—one end cap for each chamber of the partitioned carpule, the mixing chamber includes two piercing needles, one piercing needle for traversing each proximal end cap of the carpule. In an embodiment comprising two piercing needles, the piercing needles can be formed separately, providing individual conduits to deliver solution from each of the respective reservoirs of the carpule to the mixing chamber, or the two piercing needles can adjoin into a single conduit such that the contents from each dual reservoir are delivered to the mixing chamber via the single conduit.
The mixing chamber preferably comprises a turbulence apparatus disposed therewithin and separate from the mixing chamber itself, which serves to create turbulent flow of the solutions entering the mixing chamber from the partitioned carpule reservoirs, resulting in thorough mixing of the solutions immediately prior to administration of the buffered anesthetic solution through the delivery port and hypodermic transfer needle. In one preferred embodiment, the turbulence apparatus is an inert material separate and distinct from the mixing chamber, and is not formed as an integral part of the mixing chamber, i.e., it is a distinct apparatus that is not etched or formed into the wall of the mixing chamber. A preferred turbulence apparatus can be made of plastic or metal which does not interact chemically or physically with the buffered anesthetic solution and can be provided in a highly twisted or convoluted or highly porous configuration, e.g., steel wool, to facilitate turbulent flow and mixing of the solutions.
The mixing chamber comprising the turbulence apparatus preferably provides a substantially homogeneous mixture of buffer and anesthetic solutions.
In an embodiment of the syringe of the invention used with a longitudinally partitioned carpule, the syringe comprises a slotted plunger stem, wherein a slot is provided along the length of the plunger stem, to split or divide the stem into two asymmetric plunger stem portions along at least a part of, and preferably substantially the entirety of its length. Preferably, the slot is offset from the central axial plane of the plunger stem, thereby forming a single plunger stem which is asymmetrically divided into the two plunger stem portions. Each of the divided plunger stem portions is preferably shaped as a semicircle in cross-section.
Each proximal end of the slotted plunger stem portions can comprise a harpoon which can engage, and hold corresponding distal caps on a partitioned carpule, enabling the user to draw or pull back on the plunger to aspirate the syringe, as is understood in the art to determine proper location of the needle in the injection site.
The syringe of the subject invention comprising the slotted plunger stem is configured for use with a longitudinally partitioned carpule. The partitioned carpule of the invention comprises a partition disposed along the entire length of the carpule forming a single carpule comprising dual reservoirs therewithin. Each reservoir of the partitioned carpule comprises a sliding cap at its distal end. The partitioned carpule comprises at least one stationary cap or stopper at its proximal end. The partition within the carpule forming the reservoirs is preferably positioned asymmetrically, offset from the axial center, to form two reservoirs, side-by-side, each respectively containing desired volumes of the anesthetic solution and bicarbonate solution to provide the solutions at a pre-determined and desired ratio when mixed and administered to a patient.
Therefore, in one preferred embodiment of the invention, novel features of the syringe and system of the invention include but are not limited to:
It is therefore one object of the present invention to provide a system comprising an aspirating cartridge syringe which is inexpensive to manufacture, reusable, capable of being sterilized, and efficient in operation.
Another object of the present invention is to provide a mixing syringe that can deliver freshly mixed anesthetic and buffer solution, without remote pre-mixing or repeated mixing steps for subsequent administrations of anesthetic and buffer.
A further object of the present invention is to provide a mixing syringe which provides adequately mixed solutions that are accurately measured and accurately proportioned in predetermined amounts and ratios, for administration from a single, partitioned carpule.
Yet another object of the present invention is to provide a mixing syringe which can reduce waste of buffered drug solution and increase efficiency by reducing the time and effort expended by a health care professional to remotely pre-mix anesthetic and buffer solutions prior to administration of the mixture to a patient.
Still another object of the invention is to provide a mixing syringe which can provide freshly mixed solutions and preventing decrease of pH of the solution over time when multiple, staggered injections are required during a lengthy medical procedure.
It is another object of the invention to provide a mixing syringe in which a single, partitioned carpule having substantially standard size and shape can be readily and easily inserted into the cartridge syringe barrel, whereby the anesthetic solution and buffer solution can be mixed together immediately before administration by actuation of a single plunger, and the mixture of anesthetic and buffer solutions administered to a patient without pre-mixing or remote mixing of the solutions.
Another object of the present invention is to provide a method of mixing buffered local anesthetic solution which can obviate the need for on-site, remote (away from the patient) mixing devices and methods for pre-mixing a buffered anesthetic solution prior to loading into a syringe for administration.
One object of the present invention is to provide a disposable dual-reservoir, partitioned carpule which may be readily and easily inserted into a cartridge syringe barrel configured for receiving and use of a conventional carpule, and which can be readily and easily removed therefrom after use, thereby requiring no additional pre-mixing steps as compared to the use of a conventional syringe.
Another object of the present invention is to provide a syringe device that can administer local anesthetics at, or near, physiological pH by controlling the pH of the solution exiting the mixing chamber from the syringe device.
These objects or advantages of the subject device and method, as well as other embodiments, objects or advantages not expressly provided, would be apparent and readily understood by the description and drawings provided herein.
The drawings presented in this application are not to scale.
The subject invention concerns a partitioned carpule and a system for mixing and delivering buffered anesthetic to a patient without requiring remote mixing of the anesthetic and buffer prior to administration. The invention includes use of the carpule in a conventional cartridge syringe, preferably a conventional aspiration cartridge syringe, or can employ a modified cartridge syringe.
The delivery system according to the subject invention comprises a carpule partitioned to provide dual, asymmetric reservoirs within the carpule, each reservoir respectively containing a drug solution and a buffering solution. The partitioned carpule can include a longitudinally divided chamber.
The invention can employ a conventional cartridge syringe or can employ a syringe modified to comprise a mixing chamber for receiving and mixing the drug solution and buffering agent expelled from the partitioned carpule and containing therewithin the mixing chamber, a turbulence apparatus. In an embodiment comprising a longitudinally partitioned carpule, a syringe of the invention can include a longitudinally slotted plunger stem forming two asymmetric plunger stem portions which separately, but simultaneously engage a sliding cap on a distal end of each carpule reservoir for plunging each reservoir of the partitioned carpule simultaneously and expelling the contents therefrom into the optional mixing chamber.
In one embodiment, the partitioned carpule of the invention comprises a partition disposed along the entire length of the carpule forming dual, asymmetric reservoirs within the single carpule, each reservoir comprising a sliding cap at its distal end and a stopper at its proximal end. Advantageously, the partition within the carpule forming the reservoirs does not divide the carpule into equal-volume reservoirs; rather, the partition is offset from the longitudinal midline, forming asymmetrical reservoirs proportionately dividing the carpule reservoirs according to the desired and predetermined amounts and ratios of anesthetic solution and buffering solution when mixed and administered.
The subject syringe device and system includes a plunger stem comprising a slot formed along its length. Although the slotted plunger stem can be divided along its entire length, effectively forming two half stems wherein each adjoin to a thumbpiece at their respective distal ends, the plunger stem preferably comprises a slot along a portion of its length, i.e., the slot does not extend the entire length of the plunger stem, and forms an intact distal segment that is adjoined and is not slotted.
In a preferred embodiment, the slot along the length of the plunger stem forms two plunger stem portions which are separate from one another at their proximal ends and adjoin at their distal ends and form a single plunger stem for that adjoined segment. Thus, in the preferred embodiment, the plunger comprises a slotted stem segment along most, between 50-99%, of its length, and has an adjoined, single-stem segment for the remaining portion of its length. Although not limited except for practical purposes, this distal unslotted segment typically can measure about 0.5 mm to about 10 mm from the distal end, where the unslotted segment adjoins or is formed integral with the thumbpiece.
More specifically, the length of the slot in the plunger stem is formed at least the distance required to fully expel the contents of the reservoirs of the partitioned carpule, with the remainder of the plunger stem being adjoined. Typically, a conventional carpule is about 5-8 cm in length. Accordingly, the length of the slot is at least about 5 cm along the length of the plunger stem and up to about 10 mm in length but less than the entire length of the plunger stem. Therefore, the length of the slot is dependent on the travel distance required to traverse the length of the carpule partition.
The slotted plunger stem portions are preferably semicircular in cross-section, corresponding to the partitioned carpule reservoirs which are also semicircular in cross-section. Thus, the slotted plunger stem portions matingly slide into the carpule reservoirs to efficiently push the reservoir caps distally, toward the distal reservoir stopper or stoppers to expel the contents of the reservoirs into the mixing chamber and then to the delivery port and transfer needle for injection and administration to the patient.
When the plunger is actuated, the slot of the plunger stem traverses the length of the partition to engage and push the sliding cap at the distal end of each carpule reservoir the entire length of the carpule until it meets the stopper disposed at the proximal end of the carpule to permit expelling a portion and up to the entire contents of the carpule chambers through a conduit comprising two piercing needles positioned proximal to the carpule and distal to the mixing chamber. The piercing needles provide for fluid communication between the carpule reservoirs and the mixing chamber.
In addition, each proximal end of the slotted plunger stem portions can include a grasping implement or harpoon protruding from their proximal ends which can engage the sliding distal end caps of the partitioned carpule to allow for pulling or drawing back of the tip in the opposite direction for aspiration (testing whether the needle has entered a blood vessel.) These harpoons are conventional in the art.
In an embodiment of a mixing syringe of the subject invention, the proximal end of each plunger stem portion comprises a harpoon whereby, depression or actuation of the plunger thumbpiece pushes the slotted plunger stem to engage the distal carpule reservoir caps. The stabs are not permanently, rather removably engaged with the partitioned carpule caps, and can be removed for disengaging the partitioned carpule from the mixing syringe barrel.
One embodiment of the invention provides a mixing syringe which comprises a mixing chamber positioned between, and in fluid communication with, the syringe barrel and the delivery port. The mixing chamber is capable of receiving the anesthetic solution and buffering solution from a single, partitioned carpule for mixing of the solutions. A wall separates the mixing chamber from the syringe barrel, but includes two piercing needles, each piercing needle traversing a stopper in the proximal end of a carpule having dual reservoirs so that, when engaged, the contents in the dual reservoirs of the carpule are in fluid communication with the mixing chamber. The piercing needles can be separate, where each piercing needle delivers solution to the mixing chamber from each of the respective reservoirs of the carpule, or can adjoin into a single conduit such that the contents from each dual reservoir are delivered to the mixing chamber via the single conduit.
The mixing chamber preferably comprises a turbulence apparatus disposed therewithin which serves to create turbulent flow of the solutions entering the mixing chamber from the partitioned carpule reservoirs, resulting in thorough mixing of the solutions immediately prior to administration of the buffered anesthetic solution through the delivery port and hypodermic transfer needle.
In one preferred embodiment, the turbulence apparatus is an inert material separate and distinct from the mixing chamber, and is not formed as an integral part of the mixing chamber, i.e., it is a distinct apparatus that is not etched or formed into the wall of the mixing chamber. A preferred turbulence apparatus can be made of plastic or metal which does not interact chemically or physically with the buffered anesthetic solution and can be provided in a twisted or convoluted or highly porous configuration, e.g., steel wool, to facilitate turbulent flow and mixing of the solutions. Alternatively, the turbulence apparatus can be a finned disc or turbine which can facilitate mixing of the solutions by a rotational motion activated by fluid passing by the apparatus. The mixing chamber comprising the turbulence apparatus preferably provides a substantially homogeneous mixture of buffer and anesthetic solutions.
The subject invention further comprises a method of administering a mixture of anesthetic solution and buffering solution, forming a mixed, buffered anesthetic solution by employing a novel syringe as described and shown herein.
Advantages of the present invention include convenience of use and greater efficiency in a clinical setting for injectable drugs, such as anesthetics, which are commonly remotely mixed with another solution immediately prior to administration. This advantage is achieved by providing a dispensing device in accordance with the subject invention comprising a syringe barrel adapted to receive a single, asymmetrically partitioned carpule having dual reservoirs for containing anesthetic solution in a first reservoir and a buffering solution in a second reservoir.
A mixing cartridge syringe and partitioned carpule of the subject invention can be a self-contained anesthetic/buffer solution mixing and delivery system which does not require pre-mixing of the anesthetic and buffer prior to loading the syringe with anesthetic or buffer solution, nor does it require mixing to be conducted remotely or outside the syringe or system of the invention.
Turning to the drawings provided herewith,
The mixing syringe barrel 103 comprises an opening 106 or aperture in its side wall to provide for insertion and removal of a carpule containing injectable solutions. In accordance with the subject invention, a mixing syringe system includes a partitioned carpule 107, shown in cross-section in
Proximal to the mixing syringe barrel is mixing chamber 110, having a turbulence apparatus 111 disposed therein. For fluid communication between the carpule reservoirs and the mixing chamber, piercing needles 112 and 113 are provided as conduits to deliver the anesthetic and buffer solutions from the partitioned carpule into the mixing chamber. Each penetrating needle 112 and 113 can be independent from one another to deliver the solutions to the mixing chamber, or they can adjoin, proximal to the carpule reservoirs to form a single conduit for delivery of both solutions into the mixing chamber.
The mixing chamber connects proximally to a delivery port 114, which is adapted to receive and removably engage a standard hypodermic transfer needle 115, which is typically provided with a safety cap 116.
An embodiment of the unique slotted plunger stem 200 of the invention is further illustrated in
The first and second reservoirs are provided to respectively and discretely contain an anesthetic solution and a buffer solution, each reservoir independently containing a single content of either an anesthetic solution or a buffer solution.
The present invention provides advantages over prior devices in, at least the following ways:
In use, a syringe of the subject invention is manipulated and utilized in a manner similar to a conventional carpule-holding syringe, except that the carpule is partitioned to have dual reservoirs, each loaded within the syringe barrel prior to administration of a medicament.
Specifically, the method comprises the steps of:
The method can further include removing the expended carpules from the syringe barrel and repeating the above steps a) through c) as needed.
It is contemplated that the invention provides a significant role in ease-of-use and efficiency in administering local anesthetic buffered solution in a pH control fashion. The present invention provides optimal dosing control of freshly buffered local anesthetic solution at the fingertips of medical practitioners.
It is to be understood that certain descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. While the present invention has been presented in accordance with several preferred and practical embodiments thereof, it is recognized that departures from and variants of the instant disclosure are contemplated as being fully within the spirit and scope of the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/037228 | 6/14/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63038765 | Jun 2020 | US |
