1. Field of the Invention
The present invention pertains to an apparatus and method for applying a pharmaceutical to interior tissue of an ear canal. In particular, the present invention pertains to a packaged kit that includes an ear needle having a flexible absorbent applicator on a distal end of the needle, a vial of a single dose of an otologic formulation of mitomycin-C, and a diluent carrier syringe containing sterilized water. The component parts of the apparatus are used together to reconstitute the contents of the vial with the water in the diluent carrier syringe. The ear needle is then attached to and communicated with the syringe. The syringe and needle are then used to inject the reconstituted drug into the absorbent applicator at the end of the needle, and use the absorbent applicator containing the drug to apply the drug to the surface of an external ear canal for the treatment of keratosis obturans at the surface.
2. Description of the Related Art
Mitomycin-C is an anti-metabolic agent that acts by interrupting DNA synthesis. It has been used as a chemotherapy agent, for example, in stomach and pancreatic cancers, for many years. Its anti-metabolic properties have prompted ophthalmologists to consider its use as a means of improving patency in trabeculectomy surgery. This procedure is well suited for the use of mitomycin, and the use of mitomycin in the procedure has ultimately become a standard of physicians.
The successful fistulae formation in glaucoma surgery with the accompanying use of mitomycin-C has resulted in experimentation in a variety of different surgical procedures where the desired end point, a functional, patent fistulae, is the same. Notable among these procedures is the myringotomy procedure, or the surgical creation of a pathway through the tympanic membrane. It has been contemplated that mitomycin-C could similarly sustain patency of a myringotomy such that the functional objective—middle ear ventilation and the resolution of chronic acute infection—is resolved without the implementation of pressure equalization tubes. This is described in the parent patent application Ser. No. 11/556,578, which is incorporated herein by reference.
A relatively rare otologic occurrence is keratosis obturans. Keratosis obturans occurs in one in one thousand new otologic patients and is characterized by a proliferative growth and accumulation of endothelial cells within the external ear canal, i.e. the portion of the ear canal that is external to the tympanic membrane. Over time, this accumulation of cells forms a plug that obstructs the external ear canal in its entirety, thereby suppressing the hearing sense of the affected patient. The only known treatment for keratosis obturans is the routine removal of the accumulated growth of endothelial cells by way of in-office, minor surgery. In this procedure, the physician grasps the plug of endothelial tissue and removes it from the ear canal. However, this treatment is only temporary, as the mechanism that creates this prolific growth of cells is unaffected by the removal of the plug of endothelial tissue. The endothelial cells will continue to grow and accumulate in the external ear canal, resulting in a reformation of the plug suppressing the hearing sense of the affected patient.
It has been contemplated by the inventor that the concomitant use of mitomycin-C at the time of the removal of the prolific endothelial growth will limit its regrowth in the external ear canal and effectively treat the underlying psychological mechanism of keratosis obturans.
The mitomycin-C could be applied to the surface of the external ear canal by a sponge or some other absorbent, conformal delivery device, allowing for the uniform application of the anti-metabolic agent throughout the entirety of the affected pathology. The mitomycin-C could be reconstituted from lyophilized to liquid form at the time of the procedure, thereby minimizing issues of shelf life and substance fragility. It could be delivered to the external ear canal in a completely closed system, thereby minimizing inadvertent contact with a potentially hazardous material such as mitomycin-C. Finally, it could be prepared in a kit inclusive of proper disposal containment, thereby maximizing procedural convenience and further minimizing inadvertent, hazardous contact.
Thus, the present invention provides an apparatus and method for the application of a single dose of an otologic formulation of mitomycin-C to the surface of the external ear canal of a patient, where the mitomycin-C is suspended on the surface. Additionally, the mitomycin-C could be suspended on the surface by a viscous agent and/or an adhesive agent.
Still further, the apparatus and method of the invention employs a packaged kit that includes a vial of the mitomycin-C, a syringe that functions as a diluent carrier, and at least one ear needle having an absorbent, flexible applicator at the needle distal end. The diluent carrier syringe is used to extract the mitomycin-C from the vial into the syringe and mix the mitomycin-C with water in the syringe, forming a single dose of an otologic formulation of the mitomycin-C. The ear needle is then attached to the syringe and is used with the syringe to apply the mitomycin-C to the surface of the external ear canal following the removal of the plug of endothelial cells.
The apparatus of the invention and its method of use discussed above enable a safe and simplified treatment of keratosis obturans.
Further features of the invention are set forth in the following detailed description of the preferred embodiment of the invention and in the application drawing figures.
a and 3b are views of a cone-shaped absorbent applicator pad fixed on the distal end of one of the ear needles.
a-d are views of a planar, kidney-shaped absorbent applicator pad fixed on the distal end of one of the ear needles.
The component parts of the apparatus of the invention are shown in
The component parts include a vial 12 of the pharmaceutical, a diluent carrier 16 that also functions as a syringe, a plurality of ear needles 18, 22, 24, a resilient packaging block 26, a semi-rigid packaging box 28, and a sheet of packaging material 32. As stated earlier, each of these component parts is constructed of materials typically used in manufacturing similar parts.
The pharmaceutical vial 12 has a construction that is known in the art. In the preferred embodiment, the pharmaceutical contained by the vial 12 is a single dose of an otologic formulation of mitomycin-C. The mitomycin-C has a specific color. Like conventional pharmaceutical vials, the vial 12 has a top 34 that can be pierced by a syringe needle which seals closed after the needle is removed from the top 34.
The diluent carrier 16 in the preferred embodiment of the invention is comprised of a syringe 44 containing a sterile liquid such as water, and a one-way valve 46, for example a Qosina-brand valve. However, other types of diluent carriers that perform the same function as the diluent carrier 16 to be described could be used in the apparatus kit. In the preferred embodiment, the diluent carrier 16 contains sterilized water. The amount of water provided in the carrier 16 is determined to mix with the pharmaceutical contained in the vial 12 to reconstitute the pharmaceutical in the carrier 16 to a desired therapeutic concentration. The carrier 16 has a proximal end 46 that is adapted to receive the vial top 34. A needle (not shown) is positioned in the carrier proximal end 46 to pierce the vial top 34 and communicate the pharmaceutical contained by the vial 12 with the water contained in the carrier 16. The carrier proximal end 46 also functions as the plunger of the carrier syringe 44. Moving the plunger proximal end 46 away from the syringe 44 creates a vacuum inside the syringe 44 that draws the pharmaceutical from the vial 12, through the one-way valve into the syringe 44. The one-way valve prevents the reconstituted pharmaceutical inside the syringe from returning to the vial when the plunger proximal end 46 is pushed back toward the syringe 44. The carrier distal end 48 is adapted to communicate with a selected one of the ear needles 18, 22, 24. As stated earlier, diluent carriers of this type are known in the art.
Each of the ear needles 18, 22, 24 have the same basic construction, the exception being the shape of the absorbent pad fixed to the needle. Each needle 18, 22, 24 is formed from a length of 20 gauge hypodermic tubing 52 with opposite proximal 54 and distal 56 ends. An intermediate portion 58 of the tubing is formed with pairs of right angles to adapt the tubing 52 for insertion into the ear canal. A standard syringe male luer 62 is secured to each needle proximal end 54. The male luer 62 is adapted to attach to the diluent carrier syringe 44 at the syringe distal end 46 to communicate the needle tubing 52 with the syringe body 44.
The three ear needles 18, 22, 24 differ from each other in that they have different shaped applicators 68, 72, 74 at the distal ends of the needles. In the preferred embodiment, each of the applicators 68, 72, 74 is an absorbent, flexible pad fixed to the distal ends of each of the needles 18, 22, 24. In the preferred embodiment, the pads 68, 72, 74 are constructed of an absorbent material that is known in the art and is used for the transient application of a pharmaceutical such as mitomycin-C. Each of the absorbent pads 68, 72, 74 is preferably constructed of polyvinyl acetate (PVA) sponge material. This material rapidly absorbs liquid such as the mitomycin-C. The dimensions of each pad 68, 72, 74 hold a specific volume of the mitomycin-C that enables a therapeutic, single dose of the otologic formulation of mitomycin-C to be applied to the tissue of an ear. Other types of applicators could also be used on the needle distal ends.
One of the absorbent pads 68 has a cone shape that projects from the needle distal end 56 to a tip of the cone. The cone shape of the pad 68 has a center axis 76 that is coaxial with a center axis 76 of the needle distal end 56. In the preferred embodiment, the cone-shaped pad 68 has a base diameter dimension of 0.04″, and an axial length dimension of 0.12″.
Another of the absorbent pads 72 has a planar configuration that extends transverse to the center axis 76 of the needle distal end 56. This pad 72 is formed in a general kidney shape. The pad 72 has a length dimension of 0.08″, and a width dimension of 0.04″. The pad 72 has a thickness of 0.02″.
A third pad 74 has a cylindrical configuration. The center axis of the pad cylinder 74 is coaxial with the center axis 76 of the needle distal end 56. In this embodiment of the pad 74, the pad has a diameter dimension of 0.2″ and an axial length dimension of 0.4″. This pad is intended to be used in the circumferential application of mitomycin-C to the walls of the external ear canal.
Each of the above-described component parts of the apparatus is contained in the packaging of the apparatus that includes the box 28, the resilient block 26, and the sheet of packaging material 32. Each of these packaging component parts is constructed of materials used in the safe storage, transport, and disposal of pharmaceuticals and instruments used with pharmaceuticals such as mitomycin-C.
The block 28 is constructed of a resilient material such as foam rubber or polystyrene. The block 28 has a top surface 78 that is formed with a plurality of cavities or compartments 82, 84, 86. Each of the compartments 82, 84, 86 is dimensioned to receive and securely hold the vial 12, the diluent carrier 16, and the plurality of ear needles 18, 22, 24. The compartments 82, 84, 86 securely hold the component parts of the apparatus and provide cushioning of the component parts to protect the parts during their storage and transportation.
The box 28 is dimensioned with an interior 88 that receives the resilient block 26 and securely holds the block 26 in the box interior. The box has top edges 92 that border the top opening to the box interior 88. The box 28 is dimensioned so that the top edges 92 will be positioned in the same plane as the top surface 78 of the resilient block 26 when the block is positioned in the box interior 88.
The sheet of packaging material 32 can be any type of material currently used to provide a sealed enclosure of the box 28. The packaging material 32 can be shrink-wrap applied around the box 28, or can be a resealable sheet of packaging material that can be peeled back from the box top edges 92 and then resealed to the top edges after the component parts of the apparatus have been removed from the packaging and used.
In use of the apparatus of the invention according to the method of the invention, the packaging is first opened by removing the sheet material 32 from the top edges 92 of the box. This exposes the block compartments 82, 84, 86 in the block top surfaces 78. The vial 12, the diluent carrier 16, and the ear needles 18, 22, 24 may be removed from their respective compartments in the resilient block 26.
The vial 12 of pharmaceutical, preferably mitomycin-C having a specific color, is then connected to the diluent carrier proximal end 46. This communicates the pharmaceutical in the vial 12 with the interior of the carrier 16. The pharmaceutical is drawn into the syringe 44 of the carrier 16 as explained earlier, and mixes with the water in the carrier 16, reconstituting the mitomycin-C. In addition, a viscous agent and/or an adhesive agent may be mixed with the mitomycin-C in the carrier 16.
A selected one of the ear needles 18, 22, 24 is next connected to the carrier syringe 44 distal end 48. The choice of the ear needle 18, 22, 24 is made by the physician determining which configuration of absorbent pad 68, 72, 74 is desirable for applying the mitomycin-C to the tympanic membrane of the patient. In the treatment of keratosis obturans, the ear needle 24 with the cylindrical applicator 74 is preferred. With the desired ear needle 18, 22, 24 secured to the syringe distal end 42, the syringe is prepared for application of the pharmaceutical to the surface of the external ear canal.
Application of the mitomycin-C to the tympanic membrane is illustrated in
Each of the absorbent pads 68, 72, 74 enables an application of a single dose of an otologic formulation of mitomycin-C to the ear tissue. Suspending a viscous agent or an adhesive agent in the mitomycin-C enables the mitomycin-C to remain in situ on the ear tissue and cause anti-metabolic activity on the tissue that is localized and defined by the specific color of the mitomycin-C.
A laser 102 that emits a laser beam 104 that is specifically tuned to the color of the mitomycin-C applied to the tympanic membrane 96 may then be used to ablate the tympanic membrane tissue at a location defined by the specific color of the mitomycin-C applied to the tissue. The application of the specifically tuned laser beam 104 to the tympanic membrane 96 is illustrated in
Thus, the apparatus of the invention and its method of use discussed above enable a safe and simplified photodynamic laser myringotomy procedure that is not invasive and accommodates the non-compliant child patient population.
The apparatus of the invention and its method of use have been described above by reference to specific embodiments of the invention. It should be understood that modifications and variations could be made to the invention described without departing from the intended scope of the following claims.
This patent application is a continuation-in-part of patent application Ser. No. 11/556,578, which was filed on Nov. 3, 2006, and is currently pending.
Number | Date | Country | |
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Parent | 11556578 | Nov 2006 | US |
Child | 12371716 | US |