RU2303967C2 - Drain unit applicable for glaucoma treatment - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device is T-shaped and has process opening and flexible polymer magnets having multipolar magnetic field intensity of 1.0-1.5 mTesla units. Horizontal part of the drain unit ends in flexible polymer magnets on both sides and enables one to introduce it into Schlemm's canal. The flexible polymer magnets available in the vertical drain unit part enables one to introduce it into suprachoroid space.

EFFECT: enhanced effectiveness in supporting stable intraocular fluid discharge; prolonged hypotensive result of surgical glaucoma operation.

1 dwg

Description

The invention relates to medicine, and more specifically to ophthalmology, and is intended for the surgical treatment of glaucoma.

Known drainage for the treatment of T-shaped glaucoma with a technological hole (Dahan E, Ravinet E, Ben-Simon GJ, Mermoud A. Comparison of the efficacy and longevity of nonpenetrating glaucoma surgery with and without a new, nonabsorbable hydrophilic implant // Ophthalmic Surg Lasers Imaging. 2003 Nov-Dec; 34 (6): 457-63). However, with excessive scarring in the area of operation, this drainage is not effective enough, since it does not impede the development of scar tissue in the area of its location. In addition, over time, a dense connective tissue capsule forms around the drainage, replacing the entire space between the drainage and surrounding tissues, which in some cases leads to a sharp decrease in fluid outflow.

The objective of the invention is the creation of drainage for the treatment of glaucoma, which allows for a long time to maintain the hypotensive effect of antiglaucomatous surgery.

The technical result of the invention is a stable outflow of intraocular fluid, prolonged preservation of the controlled hypotensive effect of antiglaucomatous surgery. The technical result is achieved due to the fact that:

1) the location of the drainage parts with polymer elastic magnets with the induction of a constant multipolar magnetic field of 1.0-1.5 mT in the helmet head and suprachoroidal space prevents the scarring of the intraocular fluid outflow paths created as a result of surgical intervention, provides a stable outflow of intraocular fluid, helps balance intraocular pressure (IOP) between the anterior and posterior parts of the eye;

2) a weak permanent multipolar magnetic field of magnets has a local decongestant and anti-inflammatory effect, which accelerates the healing process after implantation of the drainage;

3) there is the possibility of exposure to drainage by an external constant magnetic field, as a result of which it will perform micromotion, which will allow, if necessary, to restore the filtration of intraocular fluid.

The drainage has a T-shape, one technological hole with a diameter of 0.25 mm, located in the lower zone of the vertical part and intended for suture fixation of the drainage. Drainage can be made, for example, from a polymer and / or copolymer of monomers of acrylic and / or vinyl series, as well as polyorganosiloxane. Drainage thickness - 0.2 mm. The horizontal part of the drainage is 5.0-6.0 × 0.25 mm and ends on both sides with polymer elastic magnets filled with a samarium-cobalt or neodymium-iron-boron system with induction of a constant multipolar magnetic field of 1.0-1.5 MT The size of the magnets is 1.5-2.0 × 0.1 mm. The vertical trapezoidal part with a base of 2.0 mm (towards the horizontal part), apex of 1.0 mm and a height of 2.25 mm from the apex ends with a polymer elastic magnet with the same magnetic characteristics. The width of the magnet is 0.3-0.5 mm. All magnets are polymerized in drainage.

Polymer elastic magnets are made of a polymer elastic magnetic material, consisting of a base - a polymer elastic material - and a magnetic filler. As the polymer elastic material, a biostable polymer is used, for example, based on polyacrylate, vinyl polymer or silicone rubber. Powdered particles of the magnetic filler of the samarium-cobalt or neodymium-iron-boron system are uniformly distributed in the polymer elastic material.

Drainage is implanted as follows. Processing of the surgical field and preparatory stages of the operation are carried out in a standard way. In the upper segment of the eyeball, a conjunctival flap is formed by its separation from the limb, then either a rectangular (4 × 4 mm) or trapezoidal (4 × 4 × 2.0 mm) superficial scleral flap is formed by separation to transparent layers of the cornea with a depression of 1 -2 mm, then either rectangular (2.5 × 2.0 mm) or trapezoidal (2.5 × 2.0 × 1.0 mm) deep scleral flap with preservation of the deepest layers of the sclera on the surface of the ciliary body, remove the deep scleral flap. The ciliary body is exposed by complete excision of the sclera at the top of the flap to the surface of the ciliary body, the outer wall of the Schlemm canal and corneoscleral tissue are removed to a depth of the descemet membrane. Drainage is laid on the formed bed, the ends of its horizontal part are introduced into the channel of Schlemm, and the magnet located in the vertical part of the drainage is introduced into the suprachoroidal space through an incision in the sclera. Drainage is fixed to the deep layers of the sclera with a nodal suture. A superficial scleral flap is laid, it is fixed to the sclera with two interrupted sutures, a nodular suture is applied to the conjunctiva. The operation is completed with an injection of dexazone with an antibiotic under the conjunctiva.

The invention is illustrated in the drawing. The drawing shows a drainage with a horizontal part 1, a vertical part 2, polymer elastic magnets 3 for insertion into the helmet channel, a polymer elastic magnet 4 for insertion into the suprachoroidal space, a technological hole 5.

The invention is illustrated by the following examples.

Example 1. Patient B., 73 years old. Received in the Kaluga branch of FGU MNTK "Eye Microsurgery" with a diagnosis of open-angle II-C glaucoma of the right eye. Visual acuity OD at admission 0.63 does not correct. The field of view from the bow is narrowed to 35 ° from the fixation point. Po = 28 mm RT. st .; outflow ease factor = 0.11.

The patient underwent antiglaucomatous surgery with implantation of the proposed drainage.

At the preparatory stage, after processing the surgical field, epibulbar anesthesia was performed with 1% solution of lidocaine hydrochloride in a dose of 0.5 ml, retrobulbar anesthesia with 2% solution of novocaine hydrochloride in a dose of 1.5 ml. Then, a conjunctival flap was formed and separated in the upper segment of the eyeball, then a rectangular superficial scleral flap 4 × 4 mm in size and 0.3 mm thick was cut and separated with access to the transparent layers of the cornea and 1 mm deep in them. Then a deep scleral flap of a trapezoidal shape 2.5 × 2.0 × 1.0 mm and a thickness of 0.2 mm was cut and removed with the preservation of a deep scleral layer above the surface of the ciliary body. At the top of the deep flap, a through notch was made with the ciliary body exposed. The outer wall of the Schlemm's canal and the corneoscleral tissue to the descemet membrane were removed in the region of 1 mm from the limb. A drainage with polymer elastic magnets filled with a neodymium-iron-boron system with the induction of a constant multipolar magnetic field of 1.5 mT is laid on the formed bed. The ends of its horizontal part are introduced into the Schlemm's canal, and the magnet located in the vertical part of the drainage is inserted into the suprachoroidal space through a notch in the deep layers of the sclera. The drainage has taken a stable position, its suture fixation was not required. The superficial scleral flap is laid in its place and fixed with two interrupted sutures 8-00. A suture on the conjunctiva 8-00. A subconjunctival solution of dexazone - 0.3 ml and a solution of gentamicin - 0.2 ml.

On the first day after surgery, Po was 19 mm RT. Art., the coefficient of ease of outflow of 0.17. The postoperative period was uneventful.

To enhance the filtration of intraocular fluid in the early postoperative period, an external magnetic field was applied using the BIO MPG device with a magnetic field strength of 0.3 T for 5 minutes, 2 times a day for 4 days. At discharge on the seventh day after surgery: Po = 13 mm RT. Art., the coefficient of ease of outflow = 0.2, visual acuity and field of view have not changed.

In a subsequent patient, once every 6 months, an external magnetic field was applied using the BIO MPG device according to the above procedure. During the observation period of 2 years, topographic indicators remained within the normal range.

Example 2. Patient T., 62 years old. He entered the Kaluga branch of the Federal State Institution IRTC “Eye Microsurgery” with a diagnosis of open-angle II-C glaucoma of the left eye. Visual acuity OS at admission 0.5. The field of view of the OS is narrowed from the bow to 28 ° from the fixation point. Po = 31 mm RT. st .; outflow ease factor = 0.1.

The patient underwent antiglaucomatous surgery with implantation of the proposed drainage.

At the preparatory stage, after processing the surgical field, epibulbar anesthesia was performed with 1% solution of lidocaine hydrochloride in a dose of 0.5 ml, retrobulbar anesthesia with 2% solution of novocaine hydrochloride in a dose of 1.5 ml. Then, a conjunctival flap was formed and separated in the upper segment of the eyeball, then a rectangular superficial scleral flap 4 × 4 mm in size and 0.3 mm thick was cut and separated with access to the transparent layers of the cornea and 1 mm deep in them. Then a deep scleral flap of a trapezoidal shape 2.5 × 2.0 × 1.0 mm and a thickness of 0.2 mm was cut and removed with the preservation of a deep scleral layer above the surface of the ciliary body. At the top of the deep flap, a through notch was made with the ciliary body exposed. The outer wall of the Schlemm's canal and the corneoscleral tissue to the descemet membrane were removed in the region of 1 mm from the limb. A drainage with polymer elastic magnets filled with a samarium-cobalt system with induction of a constant multipolar magnetic field of 1.0 mT is laid on the formed bed. The ends of its horizontal part are introduced into the Schlemm's canal, and the magnet located in the vertical part of the drainage is inserted into the suprachoroidal space through a notch in the deep layers of the sclera. The drainage has taken a stable position, its suture fixation was not required. The superficial scleral flap is laid in its place and fixed with two interrupted sutures 8-00. A suture on the conjunctiva 8-00. A subconjunctival solution of dexazone - 0.3 ml and a solution of gentamicin - 0.2 ml.

The postoperative period was uneventful. On the first day after surgery, Po was 21 mm RT. Art., the coefficient of ease of outflow of 0.14.

To enhance the filtration of intraocular fluid in the early postoperative period, an external magnetic field was applied using the BIO MPG device with a magnetic field strength of 0.3 T for 5 minutes, 2 times a day for 4 days. At discharge on the seventh day after surgery: Po = 15 mm RT. Art., the coefficient of ease of outflow = 0.18, visual acuity and field of view have not changed.

In a subsequent patient, once every 6 months, an external magnetic field was applied using the BIO MPG device according to the above procedure. During the observation period of 2 years, topographic indicators remained within the normal range.

Thus, the claimed drainage for the treatment of glaucoma provides a steady outflow of intraocular fluid, long-term preservation of the controlled hypotensive effect of antiglaucomatous surgery.

Claims (1)

Drainage for the treatment of T-shaped glaucoma with a technological hole, characterized in that it has polymer elastic magnets with the induction of a constant multipolar magnetic field of 1.0-1.5 mT, with the horizontal part of the drainage ending on both sides with polymer elastic magnets with the possibility of introducing a channel into the helmets, and a polymer elastic magnet located in the vertical part of the drainage, is made with the possibility of introducing into the suprachoroidal space.