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10/26/06 - USPTO Class 606 |  179 views | #20060241580 | Prev - Next | About this Page  606 rss/xml feed  monitor keywords

Device and methods useable for treatment of glaucoma and other surgical procedures

USPTO Application #: 20060241580
Title: Device and methods useable for treatment of glaucoma and other surgical procedures
Abstract: A device and method for cutting or ablating tissue in a human or veterinary patient includes an elongate probe having a distal end, a tissue cutting or ablating apparatus located adjacent within the distal end, and a tissue protector extending from the distal end. The protector generally has a first side and a second side and the tissue cutting or ablating apparatus is located adjacent to the first side thereof. The distal end is structured to be advanceable into tissue or otherwise placed and positioned within the patient's body such that tissue adjacent to the first side of the protector is cut away or ablated by the tissue cutting or ablation apparatus while tissue that is adjacent to the second side of the protector is not substantially damaged by the tissue cutting or ablating apparatus. (end of abstract)



Agent: Robert D Buyan Stout, Uxa, Buyan & Mullins - Irvine, CA, US
Inventors: Michael Mittelstein, John T. Sorensen, Soheila Mirhashemi, James B. Georg
USPTO Applicaton #: 20060241580 - Class: 606041000 (USPTO)

Related Patent Categories: Surgery, Instruments, Electrical Application, Applicators

Device and methods useable for treatment of glaucoma and other surgical procedures description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060241580, Device and methods useable for treatment of glaucoma and other surgical procedures.

Brief Patent Description - Full Patent Description - Patent Application Claims
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RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 60/477,258 filed on Jun. 10, 2003, the entirety of which is expressly incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] A. Symptoms and Etiology of Glaucoma

[0003] The term "glaucoma" refers generally to a group of diseases which cause progressive damage to the optic nerve and resultant optical field defects, vision loss and, in some cases, blindness. Glaucoma is frequently, but not always, accompanied by abnormally high intraocular pressure. Aqueous humor is continually produced by cells of the ciliary body and such aqueous humor fills the anterior chamber of the eye. Excess aqueous humor normally drains from the anterior chamber of the eye, through a structure known as the trabecular meshwork and then out of the eye through a series of drainage tubules. However, in many glaucoma patients, drainage of the aqueous humor through the trabecular meshwork is impaired, thereby causing the pressure of aqueous humor within the anterior chamber to increase.

[0004] In general, there are four types of glaucoma--primary, secondary, congenital and pigmentary. Primary glaucoma, which is the most common form, can be classified as either open angle or closed angle. Secondary glaucoma (e.g., neovascular glaucoma) occurs as a complication of a variety of other conditions, such as injury, inflammation, vascular disease and diabetes. Congenital glaucoma is elevated eye pressure present at birth due to a developmental defect in the eye's drainage mechanism. Pigmentary glaucoma is a rare form of the disease wherein pigment from the iris clogs the trabecular meshwork, preventing the drainage of aqueous humor from the anterior chamber.

[0005] Glaucoma is a leading cause of blindness in the United States. The loss of vision in glaucoma patients is typically progressive and may be due, at least in part, to compression of the vasculature of the retina and optic nerve as a result of increased intraocular pressure. It Is generally accepted that reducing intraocular pressure, through the use of drugs and/or surgery, can significantly reduce glaucomatous progression in patients who suffer from normal-tension glaucoma and can virtually halt glaucomatous progression in patients who suffer from primary open-angle glaucoma with elevated intraocular pressures. Furthermore, it is generally acknowledged that lowering intraocular pressure in glaucoma patients can prevent or lessen the irreversible glaucoma-associated destruction of optic nerve fibers and the resultant irreversible vision loss.

[0006] B. Surgical Treatment of Glaucoma

[0007] The surgical treatment of glaucoma Is generally aimed at either a) decreasing the amount of aqueous humor produced by the ciliary, body or b) improving drainage of aqueous humor from the anterior chamber of the eye.

[0008] The procedures aimed at decreasing the production of aqueous humor include cyclocryotherapy, wherein a cryosurgical probe is used to freeze a portion of the ciliary body, thereby destroying cells that produce aqueous humor, and laser cyclophotocoagulation, wherein a laser is used to destroy part of the ciliary body resulting in decreased production of aqueous humor.

[0009] The procedures intended to improve drainage of aqueous humor from the anterior chamber include trabeculoplasty, trabeculectomy, goniectomy and shunt implantation.

[0010] In trabeculoplasty, the surgeon uses a laser to create small holes through the trabecular meshwork to increase aqueous humor drainage through the normal drainage channels.

[0011] In trabeculectomy, the surgeon removes a tiny piece of the wall of the eye, which may include a portion of the trabecular meshwork, thereby creating a new drainage channel which bypasses the trabecular meshwork and the normal drainage channels. Aqueous humor then drains with relative ease through the new drainage channel into a reservoir known as a "bleb" that has been created underneath the conjunctiva. Aqueous humor that drains into the bleb is then absorbed by the body. Trabeculectomy is often used in patients who have been unsuccessfully treated with trabeculoplasty or who suffer from advanced glaucoma where optic nerve damage is progressing and intraocular pressure is significantly elevated.

[0012] In goniectomy, a tissue cutting or ablating device is inserted into the anterior chamber of the eye and used to remove a full thickness strip of the tissue from the trabecular meshwork overlying Schlemm's canal. In many cases, a strip of about 2 mm to about 10 mm in length and about 50 .mu.m to about 200 .mu.m in width is removed. This creates a permanent opening in the trabecular meshwork through which aqueous humor may drain. The goniectomy procedure and certain prior art instruments useable to perform such procedure are described in U.S. patent application Ser. No. 10/052,473 published as No. 2002/0111608A1 (Baerveldt), the entirety of which is expressly incorporated herein by reference.

[0013] In shunt implantation procedures, a small drainage tube or shunt is implanted in the eye such that aqueous humor may drain from the anterior chamber, through the shunt and into a surgically created sub-conjunctival pocket or "bleb." Aqueous humor that drains into the bleb is then absorbed by the patient's body.

[0014] Trabeculoplasty, trabeculectomy and shunt implantation procedures are sometimes unsuccessful due to scarring of closure of the surgically created channels or holes and/or clogging of the drainage tube. Because it involves removal of a full thickness strip from the trabecular meshwork, the goniectomy procedure is less likely to fail due to scarring or natural closure of the surgically created channel. Although the previously described devices can be used to successfully perform goniectomy procedures, there remains a need in the art for the development of new tissue cutting and ablation instruments that may be used to perform the goniectomy procedure as well as other procedures where it is desired to remove a strip of tissue from the body of a human or veterinary patient.

SUMMARY OF THE INVENTION

[0015] The present invention provides a device for cutting or ablating tissue in a human or veterinary patient. This device generally comprises, consists essentially of, or consists of: a) an elongate probe having a distal end, b) a tissue cutting or ablating apparatus and c) a protector that extends from the probe. The protector generally has a first side and a second side and the tissue cutting or ablating apparatus is located adjacent to the first side of the protector. The distal end of the probe having protector extending therefrom, is structured to be advanceable into tissue or otherwise placed and positioned within the patient's body such that tissue adjacent to the first side of the protector is cut away or ablated by the tissue cutting or ablation apparatus while tissue that is adjacent to the second side of the protector is not substantially damaged by the tissue cutting or ablating apparatus.

[0016] Additionally, the protector may be formed entirely or partially of an insulating material. For example, the protector may be formed of a core made of an electrically and/or thermally conductive material, for example a conductive metallic material, and may include a non-conductive coating or covering, for example a polymer coating that is electrically and thermally insulating. In some embodiments of the invention, the electrically and thermally insulating material, hereinafter sometimes simply referred to as "coating" may comprise a flexible, pliable material in comparison with the more rigid core.

[0017] In some embodiments of the invention, the protector is configured not only to provide protection to tissue located adjacent to the second side of the protector, but also may be configured to facilitate positioning and/or advancement of the device within the surgical site. In this particular regard, above-incorporated United States Patent Application No. 2002/0111608A1 (Baerveldt) describes goniectomy devices that have a foot plate sized and configured to be inserted through the trabecular meshwork and into Schlemm's Canal and to, thereafter, advance through Schlemm's Canal as the device is used to remove a portion of the trabecular meshwork. In embodiments of the present invention that are used to remove portions of the trabecular meshwork (i.e., to perform a goniectomy procedure) the protector may be configured, for example shaped and sized, for insertion and advancement through Schlemm's Canal in substantially the same manner as that described in the above-incorporated United States Patent Application No. 2002/0111608A1 (Baerveldt).

[0018] It is to be appreciated that in embodiments of the device of the present invention that are designed and /or intended for use in tissue cutting or ablating applications other than goniectomy procedures, the protector may be of any other suitable configuration required to perform the desired protection and/or positioning/guidance functions.

[0019] The tissue cutting or ablating apparatus may comprise any suitable type of apparatus that is operative to cut or ablate tissue, for example a strip of tissue. For example, the cutting and ablating apparatus may comprise a electrosurgical or radiofrequency tissue cutting or ablation apparatus (e.g., monopolar or bipolar configured electrodes), apparatus (e.g., a light guide and/or lens) that emits light energy to cause thermal cutting or ablation of tissue (e.g., pulsed or non-pulsed optical incoherent high intensity light, pulsed or non-pulsed laser light, light that is infrared, visible and/or ultraviolet, etc.), mechanical tissue cutting or ablation apparatus (e.g., knife blade(s), scissor(s), rotating cutter(s), etc.), ultrasonic cutting or ablation apparatus (e.g., an ultrasound transmission member that extends through the device to a location adjacent the first side of the protector and undergoes axial or radial ultrasonic vibration), or any other suitable mechanism.

[0020] Optionally, the device may further include one or more lumen(s) for providing fluid infusion and/or aspiration to and/or from the surgical site, for example from a remote infusion and/or aspiration source.

[0021] In some embodiments of the invention, the device is in the form of an elongate probe that is attachable to a surgical handpiece for facilitating manual manipulation of the probe. In some embodiments of the invention, the entire device is structured and intended for one time use, and in other embodiments of the invention, one or more components of the device are autoclavable and reusable. For example, in some embodiments of the invention, the device comprises a disposable catheter probe having a molded distal end including the protector and/or the cutting or ablating apparatus integrally molded or formed in the distal end of the catheter. In other embodiments of the invention, the device includes a elongate probe, made of one or more segments of stainless steel hypotubing, and including a proximal portion that is configured to be received within a conventional surgical handpiece, which may include various functionable switches, conduit ports, electrical connections and the like for enabling manual operation of the various functions of the device to be described elsewhere herein.

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