Patent Application
20080086101
There are many different pathologies and conditions that require the use of ophthalmic medications in the form of eye drops. Some of the most common conditions include infections, glaucoma, and “dry eye syndrome.” There are, correspondingly, many different types of medications for these conditions that require frequent administration. Often, however, patient compliance is problematic, so much so that it can render medication ineffective. Also, for various technical reasons, many patients, especially the elderly, have difficulty administering eye drops.
Also shown in
More specifically, there is provided a stent or tube 310 (hereafter referred to as a “stent”) with an expandable pouch 312 at its distal end and a collarette 200 at its proximal end. The expandable pouch is used to store ophthalmic medication in liquid or other form (not shown) that can be secreted or pumped onto the surface of the eye.
Stent 310 is preferably made of silicone or other inorganic, flexible material. As shown, stent 312 is inserted through the lacrimal punctum 102 and canaliculus 106 such that the expandable pouch is disposed in the nasal lacrimal sac 120. Collarette 200 includes a flange portion 204 that rests against an exterior portion of punctum 102. Just posterior to collarette 200 are (optionally) small anchoring pegs 312a, 312b that flex against the interior wall of the canaliculus after insertion to further anchor the stent 310 in place within the canaliculus. Collarette 200 further includes an opening 202 that may be covered by a suitable membrane 208 and through which medication is slowly released onto the ocular surface.
As a result of the structure of device 300, there is provided an open channel or passageway that extends from the opening 202 of collarette 200, through the entire length of the stent 310 and into the expandable pouch 312 at the distal end thereof. Ocular medication is stored within pouch 312. In one possible implementation, expandable pouch 312 may also include a micro pump (or other nanotechnology apparatus) to enhance control over the delivery of the stored medication. Because the patient's normal tears (e.g., element 125) must drain properly, expandable pouch 312 is preferably not expanded to entirely fill the volume of the nasal lacrimal sac 120, but is nonetheless sufficiently filled with medication to provide sustained release of medication.
The use of expandable pouch 312, which rests in the nasal lacrimal sac 120, is a critical and necessary improvement to the ophthalmic device disclosed in U.S. Pat. No. 6,196,993 to Cohan et al. The device disclosed herein is a much improved implantable medical device that allows a much greater volume of medication to be stored for sustained release thereof. As a result, filling of the implant is less frequent, thereby resulting in fewer doctor visits and lower cost. The implantable device 300 may also remain in place for a sustained period of time as medication can be easily refilled, as discussed further below.
The device 300 can be placed into any punctum and canaliculus in a non-operative procedure without anesthesia. The procedure may be performed, for example, in a physician's office thereby avoiding the need for costly hospital and operating rooms.
In a preferred embodiment, there is provided an inserter tool 400 as shown in
In the embodiment shown in
The rate of depletion of the stored medication will depend on several factors specific to the case being treated, but eventually the medication will likely be fully depleted. However, the device 300 can be refilled without removing it from punctum 102, canaliculus 106 or nasal lacrimal sac 120. This is accomplished by again using syringe 500 with flexible tip 502 that will fit into the opening 202. Of course, again, if there is a non-removable membrane covering opening 202, then collarette 200 is preferably pulled out of the punctum 102 sufficient to expose one-way valve 410 such that re-filling can proceed in the manner described above.
In summary, this refillable, sustained drug-release ophthalmic implant is a substantial improvement over known implants for several reasons:
The expandable pouch provides for increased storage of ophthalmic medication within the lacrimal sac. This advancement reduces the number of visits to the doctor's office otherwise required to refill the device.
By allowing the bulk of a normal course of medication to be stored within the nasal lacrimal sac, less pressure is placed onto the canaliculus making the device more comfortable for the patient.
In addition, the medical device of the present invention remains securely implanted in a patient due to the fact that it runs the length of the canaliculus and is secured on one end in punctum 102 by collarette 200 and on the other end in the nasal lacrimal sac by the expandable pouch 312. The secure nature of this implantable device is far superior to conventional punctal plugs that may easily or inadvertently fall out.
The insert tool allows for a simple procedure to be conducted within a physician's office without the need for anesthesia. This relatively simple procedure is comfortable for the patient and avoids the need for any surgical procedures, thereby reducing costs.
The specifically configured syringe allows for simple refilling with any ophthalmic medication without the need to remove the entirety of the implantable device.
Finally, the implant can be easily removed if needed, again in the physician's office without anesthesia and without damaging the nasal lacrimal sac, canaliculus or punctum.
The foregoing disclosure of the preferred embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure. The scope of the invention is to be defined only by the claims appended hereto, and by their equivalents.
Further, in describing representative embodiments of the present invention, the specification may have presented the method and/or process of the present invention as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.
This Application claims the benefit of U.S. Provisional application No. 60/840,039, filed Aug. 25, 2006, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60840039 | Aug 2006 | US |
