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Nasolacrimal duct probing, intubating and irrigating deviceNasolacrimal duct probing, intubating and irrigating device description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070276314, Nasolacrimal duct probing, intubating and irrigating device. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001]The present invention relates to devices used for normalizing the flow of fluid in tubular organs of human bodies that have been injured by a disease or an accident. More specifically, the invention relates to probes and stents used in treating canalicular and nasolacrimal duct stenosis, obstruction, lacerations or other trauma. BACKGROUND [0002]The orbital portion of the lacrimal gland is located in the superotemporal orbit and the palpebral portion of the lacrimal gland is located on the posterior surface of the superotemporal upper lid. The lacrimal gland produces the aqueous portion of the tear film. Ductules from the orbital portion of the lacrimal gland pass through the adjacent palpebral lacrimal gland to empty in the superior conjunctival cul-de-sac. Smaller accessory lacrimal glands in the upper and lower lids also contribute to tear production. The tears bathe the surface of the eye and then drain into the puncta and canaliculi in the medial upper and lower lids. The superior and inferior canaliculi join as the short common canaliculus. The tears flow from the superior and inferior canaliculi through the common canaliculus, into the lacrimal sac, and down the nasal lacrimal duct into the nose. [0003]The canaliculi can become obstructed or stenotic on a congenital basis or from trauma such as lacerations, from inflammation, from certain types of chemotherapy, such as taxotere or five-fluorouracil--which may also affect the nasolacrimal duct--or the obstruction can be idiopathic. When the upper and lower canaliculi or the common canaliculus become obstructed, tears can no longer drain from the surface of the eye through the lacrimal system into the nose. The tears well up in the eye as a result, and run down the face. The excess tears blur the vision and the patient has to constantly dab the eye. [0004]The nasolacrimal duct can also become obstructed and, as a result, damaged as a result of a congenital obstruction or an acquired obstruction. Tears stagnating in the lacrimal sac and bacteria multiplying therein lead to an infection of the lacrimal sac in many patients suffering from nasolacrimal duct obstruction. The result is a painful enlargement of the lacrimal sac swollen with pus, and a discharge over the eye. [0005]Canalicular obstruction or stenosis is usually treated by forming a new passage through the obstruction with a probe, also by dilatation with probes or with a balloon catheter. At times, a dacryocystorhinostomy (DCR) is performed. A DCR consists of the surgical creation of a new passageway from the lacrimal sac into the nasal cavity. This can be performed with a balloon catheter using an endoscope or externally through an incision. A silicon tube is most often placed in the lacrimal system whether or not a DCR is performed. [0006]In the case of trauma to the lacrimal drainage system, an intubation is performed to prevent scars from permanently clogging the canaliculi or nasolacrimal duct. In cases of canalicular or nasolacrimal duct obstruction from chemotherapy, intubation is performed as quickly as possible to prevent complete, irreversible closure. [0007]Congenital nasolacrimal duct obstruction is treated with probing or through balloon catheter dilatation. However, intubation is also needed in some resistant cases. [0008]Accordingly, intubation of the lacrimal system preferably with a silicon tube, is often performed after lacrimal surgery or as a primary treatment for nasolacrimal duct obstruction, canalicular stenosis, or canalicular laceration. The easiest device to insert is the Mini-monoka tube that consists of a silicon tube attached to a punctal plug. The tube is inserted through one canaliculus into the lacrimal sac. The plug on the proximal end of the tube is positioned at the punctum. The tube will thus stay in place without having to enter the nasolacrimal duct or the nose. Indeed, the Mini-monoka tube cannot generally be placed in the nasolacrimal duct or nose. If, however, intubation of the nasolacrimal duct is needed, then one of the two ends of the silicon tube is threaded through the canaliculus and down the nasolacrimal duct into the nose. The distal end of the tube, or of any probe attached to it, must be grasped in the nose and pulled into position. It can be very difficult to locate and grasp the tube in the nose of some patients. In some cases, it is impossible to find the tube. That is because the nasolacrimal duct empties into the nasal cavity in the inferior meatus beneath the inferior turbinate. U.S. Pat. No. 6,383,192 discloses a way to push an intubation device by means of a rod. However this method still require pulling the device out of the lacrimal duct from inside the nasal cavity. The nasolacrimal duct is very hard or impossible to visualize even with the help of a flexible endoscope. It is also very difficult to locate the duct simply by tactile sensation with an instrument. U.S. Pat. No. 6,878,165 Makino teaches another verification method involving the insertion of a miniature light at the tip of a probe or stent. The illumination of the nasal cavity offers visual proof that penetration is complete, unless, as is usually the case, the light is blocked by an edema or an accumulation of blood. [0009]Obstruction of the nasolacrimal duct occurs in 2 percent to 6 percent of newborns. Congenital nasolacrimal duct obstruction usually resolves with the use of antibiotic drops and massage of the lacrimal sac. However, a significant number of patients require surgical treatment for congenital nasolacrimal duct obstruction. A probing is usually performed in these children. If silicone intubation needs to be performed, then the location and course of the nasolacrimal duct may need to be confirmed by probing before performing intubation of the lacrimal system. [0010]Probing is performed by inserting a probe horizontally through the punctum and canaliculus into the lacrimal sac. The probe is then oriented vertically and pushed down the nasolacrimal duct into the nasal cavity. The surgeon must then confirm that the probe has penetrated all obstructions in the nasolacrimal duct and reached the nasal cavity. This is commonly done by placing a metal instrument into the nose and touching the probe. The surgeon feels for metal on metal contact indicating that the probe has entered the nasal cavity. [0011]The probe is then removed from the lacrimal system. A syringe filled with fluorescein stained water with an attached short cannula is placed in the canaliculus and the fluid is irrigated through the lacrimal system into the nose. The fluid is recovered in the nose with a suction catheter. This confirms that the lacrimal system is patent after the probing. If the fluid does not irrigate into the nose, then the probing is repeated. [0012]Probing presents several problems. The probe enters the nasal cavity through the opening of the nasolacrimal duct in the lateral nasal wall beneath the inferior turbinate. This area is difficult to access, making it often impossible for the surgeon to touch the probe in the nose with another instrument. In this event, the surgeon cannot confirm if the probe has entered the nasal cavity. Another problem is that irrigation of the lacrimal system is required to determine if the nasolacrimal duct obstructions have been opened. If irrigation through the lacrimal system down to the nasal cavity is not verified, the probing must be repeated. As a result, multiple procedures are performed that can cause repeated trauma to the lacrimal drainage system with each placement of a probe or cannula. [0013]Bleeding in the lacrimal system or nose often occurs during the probing, intubation or associated procedures. The applicant is not aware of any expedient and practical device for clearing blood from the lacrimal system. Furthermore, the only known method for removing blood from the nasal cavity is by introducing into the nose a suction catheter through the naris. It is often difficult if not impossible to position the catheter in the inferior meatus in order to remove blood around the nose end entry into the nasolacrimal duct. [0014]The probes of the prior art are solid metal rods made of steel, bronze, silver or other metal. A flattened area in the center of the probe facilitates its manipulation. [0015]The instant invention results from attempts to achieve intubation without having to retrieve the end of the tube inside the nose, to perform probing and irrigation in a single step, to expediously clear blood and other fluids from the nasal cavity and the nasolacrimal duct. SUMMARY [0016]The instant embodiments provide a simple and practical method for verifying that a nasolacrimal system probe or intubation sleeve has been inserted through all obstructions down to the nasal cavity. In some embodiments the new probe comprises a tube shaped and dimensioned to penetrate a patient's canaliculus and nasolacrimal duct. In some embodiments the tube has an axial lumen through which a tracing fluid can be injected. In some embodiments recovery of the fluid in the nasal cavity indicates that the probe has passed through any obstructions in any part of the system. [0017]Some embodiments offer a novel method of intubation of the nasolacrimal system using a sleeve that fits over the aforesaid probe and can be threaded all the way down the nasal cavity through a patient's punctum, canaliculus, lacrimal sac and nasolacrimal duct. The tip of the sleeve can be inflated to stabilize its position before the probe is withdrawn. The probe can be used to irrigate the nasolacrimal system with a tracing fluid which once recovered through a suction apparatus in the nasal cavity provides a positive indication that the sleeve is in place. [0018]A version of the probe can be adapted to suction blood, and other fluids from the nasolacrimal duct and tracing fluids from the nasal cavity. [0019]In some embodiments there is provided a device for the treatment of a patient's canaliculus and nasolacrimal duct stenosis which comprises: a tube shaped and dimensioned to penetrate said canaliculus and duct, said tube being made of a substantially hard material, and having a proximal end, a blunted distal end, an axial lumen, a total length between approximately 4 and 50 centimeters and an outer diameter between 0.125 and 4.00 millimeters; a connector at said proximal end; said lumen having at least one orifice at said distal end. [0020]In some embodiments said orifice comprises at least one radial outlet about 0.5 to 30 millimeters from said distal end, and said outlet has a diameter between about 0.025 and 2.5 millimeters. In some embodiments said material substantially is taken from a group consisting essentially of stainless steel, bronze, silver, aluminum, titanium, brass, and alloy thereof, Kevlar, Nitinol, polymide, Dacron, nylon, EPTFE and PVC; and said tube further comprises a slanted radial flange proximate to said connector. In some embodiments the device further comprises a flexible catheter having a distal end shaped and dimensioned to interlock with said connector, and a proximal end shaped and dimensioned to interlock with a syringe. In some embodiments said connector is shaped and dimensioned to interlock with a syringe. In some embodiments the device further comprises a stiffening rod diametrically sized to engage said lumen, and having a length at least equal said total length. In some embodiments said rod has an enlarged manipulable end section. In some embodiments the device further comprises a flexible sleeve having a proximal end, a distal end, an axial interior channel closed at said distal end and being dimensioned to allow said channel to be engaged by said tube, and a length shorter than said total length of said tube. In some embodiments said flexible sleeve has a radial hole proximate said distal end. In some embodiments said tube comprises a radial flange proximate to said connector, and wherein said sleeve comprises a first radial flange around said proximal end; said first radial flange being oriented at the same axial angle as the radial flange of said tube. In some embodiments said sleeve comprises a second radial flange distally proximate to said first radial flange. In some embodiments said sleeve further comprises a first sealing implement across said channel, proximate said proximal end. In some embodiments said sleeve further comprises an inflatable segment between said radial hole and said distal end. In some embodiments said sleeve further comprises a second sealing implement across said channel at a short proximal distance from said segment. In some embodiments said inflatable segment comprises said sleeve having a reduced wall thickness along said segment. [0021]Some embodiments provide a method for probing the integrity of a patient's canaliculus and nasolacrimal duct which comprises the steps of: inserting the device of some embodiments through the patient's punctum and canaliculus down the lacrimal sac; tilting the device about 90 degrees into alignment with the nasolacrimal duct; pushing the device through the nasolacrimal duct down to the nasal cavity; injecting a tracing fluid through said connector; and recovering part of said fluid from the nasal cavity; whereby recovery of a trace of said fluid confirms that the device has penetrated all obstructions and entered the nasal cavity. Continue reading about Nasolacrimal duct probing, intubating and irrigating device... 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