CA2266958A1 - Deep nasal anesthetic applicator - Google Patents

Deep nasal anesthetic applicator Download PDF

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Publication number
CA2266958A1
CA2266958A1 CA 2266958 CA2266958A CA2266958A1 CA 2266958 A1 CA2266958 A1 CA 2266958A1 CA 2266958 CA2266958 CA 2266958 CA 2266958 A CA2266958 A CA 2266958A CA 2266958 A1 CA2266958 A1 CA 2266958A1
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Canada
Prior art keywords
applicator
tip
pump
liquid
spg
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA 2266958
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French (fr)
Inventor
John K-S Lee
Bela G. Szabo
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BeLee Inc
Original Assignee
BeLee Inc
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Filing date
Publication date
Application filed by BeLee Inc filed Critical BeLee Inc
Publication of CA2266958A1 publication Critical patent/CA2266958A1/en
Abandoned legal-status Critical Current

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Abstract

A system, method, apparatus, or kit for applying medicinal liquids inside the nasal passages is mainly intended for blocking the sphenopalatine ganglion or SPG with anesthetic to treat of headaches and pain. The applicator has an applicator tube (10) with a cotton plug (18) inside the bore near the inserted tip (19), preferably housed in a bulbous enlargement. The liquid anesthetic oozes slightly while the tip of the applicator is being inserted through the nostrils toward the SPG, providing both lubrication and numbing to prevent discomfort. The device of the invention also includes a pump (20) and bottle (30) which assemble together into a unit with the applicator. The applicator has finger wings (13) to work the pump. A cap 40 is also included.

Description

DEEP NASAL ANESTHETIC APPLICATOR
FIELD OF THE INVENTION
The present invention relates to a medicinal applicator especially for treating the tissues of the nasal passages, more particularly for a sphenopalatine ganglion nerve block.
- - REVIEW OF RELATED ART
The sphenopalatine ganglion, or SPG, is a nerve cluster located only a few millimeters under the mucus membrar_e toward the posterior of the nasal passages in the spheno-maxillary fossa, close to the spheno-palatine foramen.
It is accessible through the naves (nostrils) with a straight implement, though several inches (5.5 cm) from the naves, on either side of the middle turbinate.
Because the SPG is close to the surface, topical anesthetics applied to the mucus membranes can diffuse inward and block nerve transmission through the SPG. Blockage is therapeutically useful for treating headaches and facial pain syndromes such as acute migraine, acute cluster headache, and facial neuralgias. The SPG is connected with many nerves including the facial nerve, maxillary nerve, and pterygopalatine nerves.
Racz et al, in an article entitled "Sphenopalatine Ganglion Block" at page 223 of Interventional Pain Management, edited by Steven Waldman, MD, and Alon Winnie, MD (pub. W.B.

Saunders) report dramatic reductions in severe pain due to infection, gunshot wounds, and other causes by blocking the SPG. Racz et al report that anesthetizing the SPG can eliminate pain for up to a week, even though a topical anesthetic wears off quickly. They also report lesioning (destroying) the SPG in cases of severe chronic pain. Racz et al report application of cocaine or viscous lidocaine by a cotton-tipped applicator or swab and also via a 22-gauge needle. One of their patients, a juvenile, experienced ''~0 dramatic pain relief with self-administered lidocaine to the SPG, but refused to practice it because the procedure was so unpleasant.
Where pain is occasional rather than chronic, repeated doses of anesthetic are appropriate, and it is much better if the patient can administer the block without the help of a physician. The needle used by Racz et al of course cannot be used by patients for self-administration of anesthetics to the SPG. As for the cotton swab, this too has problems in view of the discomfort involved.
Jordan Yee in U.S. Patent 4,886,493 asserts that self-administration with a swab is not practical, and states that anaesthetic should only be applied to the SPG on a cotton swab by a specialist physician. Yee notes that pain and inability to control the dose accurately occur with cotton swab application. Yee also notes the disadvantages of special intra-nasal devices developed by other previous workers, including atomizers (which he says are liable to drip anesthetic) and wicks (which Yee says cannot deliver a precise amount of medication). An example of a wick applicator which Yee cites is U.S. Patent 3,369,543 to Ronco which discloses a hollow casing with a "wick" at the end to provide "capillary transmission of the medicine to the area to be treated". The medicinal liquid is forced by squeezing a polyethylene container casing 11, and the rate of flow through the wick is said to be controlled by the squeezing pressure. Ronco's applicator is not intended for intra-nasal use or directed '-1~ toward anesthetics.
One problem mentioned by Yee, but not solved by him, is precise control of the dosage applied inside the nose. If too little is applied, the SPG block will not work; if too much, the lidocaine, cocaine, or other liquid anesthetic will drip down causing throat irritation and systemic hypotension, which may even pose a danger of shock.
Yee discloses his own applicator, for which he claims "an extremely high degree of success" (7;53) in self-administration of anesthetic to the SPG. A bottle and pump are attached to a long tube from the end of which liquid anesthetic is sprayed when the pump is worked. Yee states that the liquid "emerges as a jetstream delivering fine droplets to the area of the pterygopalatine fossa", and that this is important because it disperses the medicine over a wide area, but it is not clear why the tube end should spray instead of squirting, like a hose, in a single stream. It is also unclear how Yee's claimed fine droplet dispersion differs from that of the "atomizers" which Yee criticizes.
Yee includes a foam collar at the end of the tube, but this apparently has no relation to the way the liquid emerges from the tube. Yee states (6;55) that the foam collar is "wetted with water to act as a lubricated plug for creating a sealing effect when it wedges between the nasal septum and the lateral wall of the nose [to] minimize backflow of sprayed fluid ... down the throat." It is not clear how this works, ''10 except perhaps as a blotter, because dammed-up excess liquid would run down as soon as the dam is released. It is unclear whether the foam is absorbent, open-cell foam or closed-cell foam wh_ch can only be "wetted" on the outside surface. Any blotter function, assuming an open-cell foam, would be minimized by pre-wetting of the foam with water, as taught.
The effectiveness of Yee's foam plug is a_uestionable. The anatomy of the nasal passages, where the SPG is located, is similar to a hole in a plate. The plate is the middle turbinate, a vertically-aligned bone plate dividing the nasal passages down the middle; the spheno-palatine ganglion is located, roughly speaking, inside the hole. The foam plug prevents the tip of the tube from approaching the exact location of the SPG, and it appears that the projected mist must for the most part bypass the hole. How the foam plug prevents "backflow" is not evident. Moreover, the exterior foam is somewhat dangerous because it can come off the tube er_d and lodge in the nasal passages.
Although the foam is softer than the tube it surrounds, it will still lead to substantial discomfort during insertion because the mucus membranes are very sensitive and any intrusion into the nose generates discomfort even if there is no pain. Yee's device cannot anesthetize the mucus membranes as it passes over them, and if anesthetic is sprayed from the tip then large areas of the nasal passages will be soaked and there will be danger of an overdose.
The volume specified by Yee to be sprayed into the '-10 nose, namely at least 1/16 cc, is two to three times larger than it needs to be; apparently the mis-direction of the spray is the reason for this great volume.
Yee includes arrow-like attachments 6 for rotatably aligning the inserted tube about its axis when it is inserted into the nose. However, their function is obscure since Yee's asserted "shotgun-like" (7;37) spray must be radially symmetrical about the tube axis, and the angle appears to be immaterial.
Yee also provides markers to show insertion depth.
These are not needed because once the patient has guided an object to the location of the SPG once or twice, accurate guiding the next time can be accomplished by feel.
The prior art does not disclose any device for applying an anesthetic block to the sphenopalatine ganglion which meets the needs of self-administration and avoids the above-noted problems. The ideal device will deliver a precise dose of liquid anesthetic to the mucus membrane over the SPG, and not elsewhere, thus avoiding treating other areas of the nasal passage which do not need it and minimizing the total amount of liquid inserted into the nose. The smaller the volume, the less chance of side-effects, which can be dangerous when drugs such as cocaine are being administered.
SUMMARY OF THE INVENTION
The present invention has an object, among others, to overcome deficiencies of the prior art as noted above.
The present inventors had experimented with spray-tip implements, somewhat like that asserted by Yee, with very fine orifices to achieve the spray effect, down to a thousandth of an inch. It was found that no matter how small the orifice or how fine the spray, dripping of anesthetic away from the SPG site occurred; and as noted above, this is uncomfortable at best and would be seriously dangerous at worst.
To achieve its objects (and others that will be apparent from this disclosure), the present invention employs a small mass of intertwined fibers, either natural or synthetic, preferably either natural or so-called synthetic cotton, hereinafter collectively simply referred to as a cotton plug, inserted inside the tip of an applicator tube, the latter of which is inserted through the nostrils to deliver anesthetic liquid to the SPG (sphenopalatine ganglion). The cotton plug is located just before the proximal orifice (i.e. the tip of the applicator which is inserted and which contacts the SPG area), preferably in an enlarged or bulbous space designed to hold the cotton plug in place. The cotton plug controls the flow of liquid medicine to prevent both spraying and dripping of excess liquid into the nasal passages while, at the same time, permitting the exact required quantity of the liquid to be applied as a liquid globule to the desired spot near the SPG.
Besides the elongated hollow applicator tube to be inserted into the nostrils and to reach the SPG, the ''10 applicator of the invention also has a bottle for holding liquid lidocaine, cocaine, or other anesthetic, and optionally morphine or any other liquid or liquefiable medicine, and a pump for delivering a predetermined dose from the bottle into the elongated applicator tube when the applicator tube is forced toward the bottle. The bottle, pump, and applicator tube are all assembled into one unit, preferably by press-fitting. The proximal end of the applicator tube, which mates with the pump/bottle assembly, preferably includes convenient handle portions which permit the applicator tube to be moved toward the bottle/pump assembly to work the pump. The pump is worked by pressing the handle portions of the applicator tube toward the bottle until pumped liquid medicine fills the applicator tube and begins to ooze from the orifice at the distal tip, which is the part farthest from the bottle and pump when the applicator tube is assembled to them.
As indicated above, natural cotton (or other natural fiber) is preferred for the plug because it seems to best control the formation of the desired liquid globule, although synthetic fibers and/or other natural fibers can be used for the purposes of the invention. The inventors have found that natural cotton works better than other materials, and suppose S that its superiority is due to the irregularity of the shape which creates pores of various sizes. Any porous material is within the scope of the present invention.
The applicator is made of slightly springy (elastic) material, preferably polyolefin, and exerts a slight pressure ''10 on the liquid medicine inside. Once the pump is worked enough so that liquid reaches the orifice at the proximal end, the liquid will continue to ooze slightly from the orifice. The hydraulic resistance of the cotton plug controls the oozing rate. The oozing rate is such that, as the tip is moved into 15 the nose, the anesthetic provides both lubrication and dulling of any pain or discomfort. This is a major improvement over the prior art, in which the discomfort level prevented use of SPG block in some cases. With the method and apparatus of the present invention the tissue tends to be numbed locally, i.e.
20 only at the tip contact point and along the contact line of the applicator, to reduce the discomfort as the proximal tip is guided into contact with the mucus membrane adjacent to the SPG.
The user can tell the location of the applicator 25 inside the nasal passages by the sense of touch, and also can sense resistance forces through his or her hand which holds the applicator or bottle.
Because the cotton plug does not protrude from the end of the applicator, it does not directly contact the tissues to be treated, which greatly reduces the risk of contamination, overdose of medication, irritation of the throat, or trauma to the mucous membranes of the SPG area.
The aforementioned Yee patent gives a bibliography of SPG block literature, discusses the anatomy of the SPG
site, and lists many diseases which can be treated by SPG
blockage; the present invention can be used to treat the same '-1~ diseases which are listed by Yee.
BRIEF DESCRIPTION OF THE DRAWING
The above and other objects and the nature and advantages of the present invention will become more apparent from the following detailed description of an embodiment taken in conjunction with drawings, wherein:
Fig. 1 is an exploded perspective view of a preferred embodiment of an applicator device in accordance with the invention; and Fig. 2 is a cross-sectional view of a proximal tip portion of the applicator showing the cotton plug.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Fig. 1 shows an applicator in accordance with the invention, which is assembled into a unit during use, exploded into its main parts: applicator tube 10, pump 20, bottle 30, and cap 40. The bottle 30 holds a liquid local anesthetic such as for example lidocaine, benzocaine, dibucaine, procaine or cocaine, or indeed any local anesthetic in liquid form, and/or some other medicine. Before assembly of the applicator onto the pump 20, the cap 40 covers the proximal end of the 5 pump 20 (the upper end in Fig. 1) so as to preserve sterility, prevent evaporation, and so on. The cap 40 preferably connects onto the pump 20 by a friction press-fit, although any other easily releaseable connecting means can be used.
The pump 20 preferably screws onto the bottle 30 by '10 bottle threads 32, which mate with similar threads inside the base of the pump 20 (not visible in Fig. 1) in the conventional way;~however, the pump and bottle can be integral in alternative embodiments (not shown), or can be connected by other connecting means. The pump 20 includes a draw tube 23 at its lower end, which is immersed in the medicinal liquid inside the bottle 30, and a protruding coupling tube 21 at its upper end, which mates with the applicator tube 10 as described below. The upper end of the pump 20 includes a cylindrical extension 22.
The pump 20 has inside it a conventional pump mechanism (not shown in Fig. 1) preferably of the type often found in liquid soap dispensers and the like. Such a pump comprises a piston working in a cylinder to exert pressure on the liauid and one or more stop valves arranged to prevent backflow. The stop valves are preferably of the type made of a ball sealing against a valve seat molded into the pump body, which is preferably of plastic, and/or a coil spring pressing the ball against the seat. However, any pumping mechanism can be used.
The coupling tube 21 is connected to the pump mechanism, e.g. the piston, so that it is movable relative to the main body of the pump 20. When the tube 21 is forced downwardly toward the pump 20, liquid inside the cylinder of the pump 20 is forced out of the upper end of the coupling tube 21. When the coupling tube 21 is released, the internal spring pushes it back up and the pump draws liquid from the '~1~ bottle 30 into the cylinder by way of the draw tube 23.
The base of the applicator tube 10 has an annulus 12 which resembles a short length of pipe protruding downward.
The annulus 12 is surrounded by the extension 22 of the pump 20 and slides over it when the pump is worked by moving the applicator tube 10 downwardly. This provides lateral support for the applicator tube 10. Two finger wings 13 are provided on the base above the annulus 12 for pressing the applicator 10 towards the bottle 30 to work the pump 20.
The base of applicator tube 10 has a cylindrical bore 11 (hidden in Fig. 1) which fits firmly over the outside of the coupling tube 21 and forms a liquid-tight seal against the coupling tube 21, preferably by a press-fit friction interference. The bore 11 communicates internally with the tip 19 of the applicator tube 10 (also seen in Fig. 2) by way of the elongated main length 15 of the applicator tube.
Fig. 2 shows an optional but preferred bulbous portion 16 in cross section at the tip 19 of the applicator tube 10 just upstream from the orifice 17. A cotton plug 18 is visible inside the hollow interior space of the tip 19.
The plug provides series hydraulic resistance to the flow of liquid medicine through the bore of the main length 15, the plug 18 and out the orifice 17. The bulbous portion 16 also helps to retain the cotton plug 18 in position. However, the applicator of the present invention works well even ir_ the absence of the bulbous portion 16.
The present invention contemplates other shapes for '-lfl the tip of the applicator tube than that shown, and other means of holding the cotton plug in place, e.g. adhesive, rough, corrugated, or fibrous inner surfaces of the applicator tip, and so on. Also contemplated are various positions for the plug of fibrous or porous material, besides the above-i5 disclosed position just inside the orifice 17. Any hydraulic resistance element is within the scope of the present invention, especially a fibrous or porous element, but including a small orifice, capillary tubes, etc.
The preferred method of using the applicator of the 20 present invention is as follows:
After any protective wrappings are removed ==om the bottle and the applicator 10, pump 20, and/or bottle 30, the cap 40 is removed from the pump 20 and the applicator i0 is put in the position of the cap 40 and pressed firmly into 25 place. The pump 20~is operated by the finger wings 13 until a drop of liquid medicine begins to ooze from the orifice 17.
Using a sterile implement or gloved finger, the liquid is smeared over the exterior of the tip 19 and/or a portion of the stem or main length 15 of the applicator tube, especially an adjacent portion.
The applicator 10 is inserted at the correct vertical angle to hit the SPG from the nostril, and also angled slightly to the left or right; if inserted into the right nostril the applicator 10 should be angled outwardly to the right, and conversely if inserted into the left nostril it should be angled slightly to the left. This lateral or left-'-10 right aiming can use as a target the respective eyeball, i.e.
when in the right nostril the applicator is aimed toward the right eyeball and conversely for the left.
The applicator 10 is inserted with the coating of liquid medicine acting as lubricant. If resistance is encountered the pump 20 may be operated again to ooze additional liquid from the tip 19.
At the full-insertion distance of two and a half to three inches (6-8 cm), with the tip 19 at the SPG, slow pumping, preferably with fractional displacement of the full stroke of the pump 20, is used to medicate the SPG. After a an interval the pumping is stopped. The patient will experience a change in his or her condition within 10 to 40 seconds if the SPG is medicated. If more medicine is needed additional pumping can be done.
It has been found that the best results are obtained when the patient lies face-up on a table with the head tilted back at 30 to 40 degrees below the horizontal.
The patient may self-administer the liquid medicine in the correct dosage by the method described above after training by a physician or health worker.
The present invention includes applicators with a stem or main length 15 and tip 19 of smaller dimensions than are shown in the drawing, for use by persons having narrow nasal passages, and/or use in the ear or other orifices. The invention is shown in the drawing approximately full size.
The industrial applicability of the present '-1~ invention is in treating pain. The problem solved by the invention is poor control of dosage blocking the SPG with topical anesthetics.
The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without undue experimentation and without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. The means and materials for carrying out various disclosed functions may take a variety of alternative forms without departing from the invention.
r Thus the expressions "means to..." and "means for..." as may be found in the specification above and/or in the claims below, followed by a functional statement, are intended to define and cover whatever structural, physical, S chemical or electrical element or structure may now or in the future exist carries out the recited function, whether or not precisely equivalent to the embodiment or embodiments disclosed in the specification above; and it is intended that such expressions be given their broadest interpretation.

Claims (4)

1. An applicator for applying anesthetic liquid through the nose to the sphenopalatine ganglion, comprising:
a reservoir bottle for holding the anesthetic liquid;
an elongated applicator tube for insertion through the nares to a region adjacent the sphenopalatine ganglion and for delivery of a globule of anesthetic liquid originating from the reservoir bottle to the sphenopalatine ganglion, said elongated applicator tube having a tip with an orifice at said tip;
a pump mechanism for delivering a controlled amount of anesthetic liquid from said reservoir bottle to said tip;
and an hydraulic resistance element upstream of said tip to produce a liquid globule of the anesthetic liquid at said tip responsive to effecting operation of said pump mechanism.
2. An applicator according to claim 1 wherein said hydraulic resistance element is a cotton plug located within said elongated applicator tube adjacent said orifice.
3. An applicator according to claim 2 wherein said elongated applicator tube comprises a bulbous portion within which said cotton plug resides.
4. A method for applying a globule of anesthetic liquid to the sphenopalatine ganglion, comprising:

providing an applicator in accordance with claim 1, said applicator containing an anesthetic liquid;
and engaging said pump to produce a globule of anesthetic liquid at said tip, and inserting said elongated applicator tube through the nares to a region adjacent the sphenopalatine ganglion so as to deposit anesthetic liquid to said region.
CA 2266958 1998-04-17 1999-03-25 Deep nasal anesthetic applicator Abandoned CA2266958A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6133298A 1998-04-17 1998-04-17
US09/061,332 1998-04-17

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CA2266958A1 true CA2266958A1 (en) 1999-10-17

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100030188A1 (en) * 2008-08-01 2010-02-04 Tian Xia Methods for Ameliorating Pain and Devices for Delivering a Medicament
US8690839B2 (en) 2008-08-01 2014-04-08 Tian Xia Devices for delivering a medicament and connector for same
US9248266B2 (en) 2013-12-17 2016-02-02 Biovision Technologies, Llc Method of performing a sphenopalatine ganglion block procedure
USD772406S1 (en) 2014-12-16 2016-11-22 Biovision Technologies, Llc Surgical device
US9516995B2 (en) 2013-12-17 2016-12-13 Biovision Technologies, Llc Surgical device for performing a sphenopalatine ganglion block procedure
US9597486B2 (en) 2010-11-15 2017-03-21 Tian Xia Methods for ameliorating pain and devices for delivering a medicament
US9694163B2 (en) 2013-12-17 2017-07-04 Biovision Technologies, Llc Surgical device for performing a sphenopalatine ganglion block procedure
US10016580B2 (en) 2013-12-17 2018-07-10 Biovision Technologies, Llc Methods for treating sinus diseases
US10525240B1 (en) 2018-06-28 2020-01-07 Sandler Scientific LLC Sino-nasal rinse delivery device with agitation, flow-control and integrated medication management system

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011529725A (en) * 2008-08-01 2011-12-15 ティアン シャ, Method for alleviating pain and device for delivering medication
US8231588B2 (en) * 2008-08-01 2012-07-31 Tian Xia Methods for ameliorating pain and devices for delivering a medicament
US8690839B2 (en) 2008-08-01 2014-04-08 Tian Xia Devices for delivering a medicament and connector for same
US20100030188A1 (en) * 2008-08-01 2010-02-04 Tian Xia Methods for Ameliorating Pain and Devices for Delivering a Medicament
US9597486B2 (en) 2010-11-15 2017-03-21 Tian Xia Methods for ameliorating pain and devices for delivering a medicament
US9248266B2 (en) 2013-12-17 2016-02-02 Biovision Technologies, Llc Method of performing a sphenopalatine ganglion block procedure
US9510743B2 (en) 2013-12-17 2016-12-06 Biovision Technologies, Llc Stabilized surgical device for performing a sphenopalatine ganglion block procedure
US9516995B2 (en) 2013-12-17 2016-12-13 Biovision Technologies, Llc Surgical device for performing a sphenopalatine ganglion block procedure
US9694163B2 (en) 2013-12-17 2017-07-04 Biovision Technologies, Llc Surgical device for performing a sphenopalatine ganglion block procedure
US9839347B2 (en) 2013-12-17 2017-12-12 Biovision Technologies Llc Method of performing a sphenopalatine ganglion block procedure
US10016580B2 (en) 2013-12-17 2018-07-10 Biovision Technologies, Llc Methods for treating sinus diseases
US10046143B2 (en) 2013-12-17 2018-08-14 Biovision Technologies Llc Surgical device for performing a sphenopalatine ganglion block procedure
US10420459B2 (en) 2013-12-17 2019-09-24 Biovision Technologies, Llc Method of performing a sphenopalatine ganglion block procedure
US10589072B2 (en) 2013-12-17 2020-03-17 Biovision Technologies, Llc Methods for treating sinus diseases
US11058855B2 (en) 2013-12-17 2021-07-13 Biovision Technologies, Llc Surgical device for performing a sphenopalatine ganglion block procedure
USD772406S1 (en) 2014-12-16 2016-11-22 Biovision Technologies, Llc Surgical device
US10525240B1 (en) 2018-06-28 2020-01-07 Sandler Scientific LLC Sino-nasal rinse delivery device with agitation, flow-control and integrated medication management system

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