KR20150003048U - An Apparatus for Treating Ocular Diseases Induced by Increased Intraocular Pressure - Google Patents

Abstract

The present invention relates to a device for treating ocular diseases induced by elevated intraocular pressure. The ophthalmic device for the treatment of ophthalmic diseases according to the present invention is superior to the conventional Ahmed valve implant and Baerveldt implant in that donor tissues are unnecessary, the risk of tube exposure is reduced, the postoperative intraocular pressure is easy to control and the perforation window is small, The number and types of postoperative procedures are reduced and the number of patients with early postoperative complications is reduced.

Description

[0001] The present invention relates to an apparatus for treating an ocular disease induced by elevated intraocular pressure,

The present invention relates to a device for treating ocular diseases induced by elevated intraocular pressure.

Patients with glaucoma who do not control intraocular pressure even under intraocular pressure lower the intraocular pressure by creating a detour to allow aqueous humor to flow under the conjunctiva outside the eye in the anterior chamber of the eye. Glaucoma filtration, which creates a bypass or fistula for waterproof drainage, may fail to control intraocular pressure due to decreased watertightness due to closure of the bypass after the surgery. In cases of failed primary surgery and reopening of glaucoma filtration, the incidence of posterior closure occlusion increases and the surgical success rate is poor.

According to the type of glaucoma, so-called glaucoma such as secondary glaucoma due to neovascular glaucoma or uveitis also has frequent blockage of the detour after glaucoma filtration, resulting in poor results.

In the case of a patient with a history of failed glaucoma filtering surgery or refractory glaucoma, surgery is performed to prevent glaucoma closure and to improve the success rate of glaucoma. The glaucoma drainage device is made up of a tube that acts as a passageway for waterproofing from the front of the eye and a small disc or membrane artifact that creates a space underneath the conjunctiva outside the eye or underneath the tehnon sac to temporarily gather waterproofing.

Several types of implants have been developed and used since Molteno implants introduced in 1968, followed by Krupin-Denver implants, Baerveldt implants and Ahmed implants. Almost all of them are made of silicone. Each implant uses a silicone tube as a watertight outflow channel, and the tube size is similar to that of an outer diameter of 640 μm and an inner diameter of 300 μm. Of these, Ahmed implants and Baerveldt implants are the most commonly used.

The thickness of the tubes used in these implants is much larger than the amount of water leakage required to control the intraocular pressure, so it is necessary to have a valve device capable of controlling the outflow, or to temporarily insert the wick in the tube or tie the circumference of the tube to prevent excess water leakage Of the Act. In addition, since the tube is thick and the tube installed under the conjunctiva protrudes from the eyeball surface, the tube may be exposed and a dangerous situation may occur over a long period of time. To prevent this, a tube must be covered with a separate tissue at the time of surgery. It covers the donated hard membrane, cardiac membrane, fascia or scleral tissue.

Thus, the present inventors have tried to improve the drawbacks of conventional glaucoma drainage devices.

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to state the level of the art to which this invention pertains and the contents of this invention are more clearly described.

Korean Patent No. 10-0323807

The present inventors have sought to develop a treatment device for ocular disease induced by elevated intraocular pressure due to a decrease in the flow of the anterior fluid. As a result, it was found that a membrane plate for receiving the purified water, a fine tube connected to the membrane plate and having a length of 20-40 mm, an inner diameter of 130-230 μm and an outer diameter of 250-400 μm, As a result of surgery on patients with glaucoma, a device composed of a tube inserted into the tube and a wick positioned to the membrane plate was manufactured. As a result, no tissue for protecting the micro tube was required, the risk of exposure to the conjunctival surface of the micro tube was reduced, It was confirmed that there was little leakage around the anastomotic tube, easy control of water leakage and easy control with proper intraocular pressure, early postoperative complications were reduced, and prognosis of surgery was improved.

Therefore, the object of the present invention is to provide an apparatus for treating ocular diseases induced by elevated intraocular pressure.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, the claims and drawings.

According to one aspect of the present invention, the present invention provides an apparatus for treating ocular diseases induced by elevated intraocular pressure, comprising: (a) an aqueous humor accommodated and non-porous (non-porous) a membrane plate, which can be folded and unfolded, comprising a porous or porous low porosity polymer; (b) a micro-tube having a length of 20-40 mm, an inner diameter of 130-230 [mu] m and an outer diameter of 250-400 [mu] m, which is connected to one end of the membrane plate and the other end is composed of an inner water outlet, a fine tube; And (c) a core which is inserted through the inner water outlet of the micro tube and is located inside the membrane plate, wherein the wick is moved to or removed from the outlet of the micro tube to adjust the flow rate of the water.

The present inventors have sought to develop a treatment device for ocular disease induced by elevated intraocular pressure due to a decrease in the flow of the anterior fluid. As a result, it was found that a membrane plate for receiving the purified water, a fine tube connected to the membrane plate and having a length of 20-40 mm, an inner diameter of 130-230 μm and an outer diameter of 250-400 μm, As a result of surgery on patients with glaucoma, a device composed of a tube inserted into the tube and a wick positioned to the membrane plate was manufactured. As a result, no tissue for protecting the micro tube was required, the risk of exposure to the conjunctival surface of the micro tube was reduced, It was found that there was no leakage around the aneurysm and the control of the water leakage was easy and the initial postoperative complication was decreased and the prognosis of the operation was improved.

According to a preferred embodiment of the present invention, the ocular disease induced by elevated intraocular pressure is glaucoma.

In the eye, a water-proof liquid is generated and discharged at a constant rate out of the eye to maintain the intraocular pressure. When there is an abnormality in the generation and discharge of the waterproofing, the intraocular pressure rises. When the intraocular pressure rises, the optic nerve head is pressed and the optic nerve is damaged Results. Glaucoma occurs in the visual field due to the extent of damage to the optic nerve and gradually progresses to blindness as the disease progresses.

According to a more preferred embodiment of the present invention, the glaucoma is selected from the group consisting of congenital glaucoma, traumatic glaucoma, glaucoma, ocular hypertension, primary open right glaucoma, normal tension glaucoma, Glaucoma secondary to trauma to the eye, glaucoma secondary to the inflammation of the eye, glaucoma secondary to the drug, glaucoma secondary to thrombocytopenic purpura, hypotonic glaucoma, pigmentary glaucoma, primary closed right-angle glaucoma, acute closed right-angle glaucoma, Secondary glaucoma secondary to neovascular glaucoma or uveitis.

Hereinafter, an apparatus for treating ocular diseases induced by elevated intraocular pressure of the present invention will be described in detail as follows:

The device for treating eye diseases of the present invention mainly comprises (i) a membrane plate; (Ii) a fine tube; And (iii) wicks.

(I) a membrane plate

The device for treating eye diseases of the present invention includes a foldable and thin membrane plate that is made of non-porous or low porosity polymer that accepts aqueous humor. The membrane plate is a reservoir in which the waterproofing is temporarily collected under the conjunctiva outside the eye or the tenon's capsule in an apparatus for treating eye diseases.

One of the most important features of the present invention is that the membrane plate included in the present invention can be folded and unfolded, and it is thinner than conventional implants, which makes it possible to reduce the size of the surgical incision.

The membrane plate is comprised of a non-porous or low porosity polymer, and preferably the non-porous or low porosity polymer is a fluoropolymer, Silicon or SIBS [poly (styrene-block-isobutylene-block-styrene)]. More preferably, the fluoropolymer is polytetrafluorethylene, expanded polytetrafluorethylene (e-PTFE) , Polyhexafluoropropylene (PHFP), and perfluoroalkoxy polymer (PFA), and more preferably is e-PTFE (expanded polytetrafluorethylene).

According to another preferred embodiment of the present invention, the membrane plate is 12-26 mm wide and 10-14 mm long.

(Ii) a fine tube

The apparatus for treating ocular disease of the present invention is connected to one end of the membrane plate and the other end is made of an outflow water outlet, and has a length of 20-40 mm, an inner diameter of 130-230 μm and an outer diameter And a fine tube having a diameter of 250-400 [mu] m.

One of the greatest features of the present invention is that the diameter of the tube for waterproofing is smaller than the conventional Ahmed valve implant and Baerveldt implant as shown in Fig. The Ahmed valve implant and the Baerveldt implant have a diameter of 640 μm and an inner diameter of 300 μm, while the tubes used in the present invention are fine tubes having an inner diameter of 130-230 μm and an outer diameter of 250-400 μm.

As a result of using these different microtubes, it is clear that donor tissues are unnecessary, the risk of tube exposure is reduced, the postoperative intraocular pressure is easy to control, and the perforation window is small, The number and types of post-operative treatments are reduced, and the number of patients having initial post-operative complications is reduced.

The apparatus for treating eye disease according to the present invention including the microtubes can be used primarily for patients without previous surgery, and can be applied to patients with failed glaucoma surgery or patients with refractory glaucoma.

According to another preferred embodiment of the present invention, the microtube is a silicon material.

(Iii) Wick

Finally, the present invention includes a wick that is inserted through the inner water outlet of the micro tube and positioned to the inside of the membrane plate, and moves or removes to the front and rear of the outlet of the micro tube to control the flow rate of the water.

As can be seen from the following examples, the device for treating eye diseases according to the present invention has significantly fewer anterior chamber formation treatments compared to conventional implants. This is because the wick inserted into the inner diameter of the fine tube Because it is rarely to fall into postoperative hypotony.

The wick is preferably a surgical nonabsorbable surgical suture, more preferably the wick is a surgical nonabsorbable surgical suture made of nylon or prolene material.

The features and advantages of the present invention are summarized as follows:

(a) The present invention provides an apparatus for treating ocular diseases induced by elevated intraocular pressure.

(b) The device for treating eye diseases according to the present invention does not need to cover the tube by using a fine tube rather than the implant used in the prior art glaucomatous surgery, and donor tissue for covering the tube is not required.

(c) The microtube used in the present invention is thin and does not protrude into the conjunctival surface or protrudes, so that the risk of tube exposure is reduced.

(d) This device can be easily removed after holding the wedge inserted for reaching the appropriate intraocular pressure for a certain period of time, thereby reducing the patient's discomfort. In addition, surgery is simpler as it does not require additional steps such as bundling the tubes or inserting the wicks again during surgery, as is done in the existing implant surgery.

(e) In the case of postoperative high postoperative IOP, adjustments can be made to increase the watertightness by lowering the wedge inserted into the tube by the desired length, thereby lowering it to the appropriate intraocular pressure.

(f) On the other hand, when inserting the tube into the front side, the conventional tube is thicker, so that the perforation window for insertion is larger, and the water leakage around the tube is likely to occur. However, when the micro tube used in the present invention is used, the amount of the perforated window is negligible even if the percolation window is small and the water drainage occurs.

(e) The device for treating eye diseases of the present invention reduces the number and types of post-operative treatments and reduces the number of patients with post-operative complications compared to conventional Ahmed valve implants and Baerveldt implants.

1 shows an apparatus for treating eye diseases according to an embodiment of the present invention.
FIG. 2 shows the difference in diameter between a fine tube used in an apparatus for treating eye diseases according to an embodiment of the present invention and a tube used in a conventional Ahmed valve implant and a Baerveldt implant.
FIG. 3 is a graph comparing the 1-year prognosis (intraocular pressure) of the Ahmed valve implant and the Baerveldt implant after surgery according to an embodiment of the present invention and a comparative example.

Hereinafter, the present invention will be described in more detail by way of examples. It will be apparent to those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .

Example

Example 1: Preparation and operation of a device for treating glaucoma

First, an expanded poly (tetrafluoroethylene) (e-PTFE) membrane was cut to 18 mm in width and 13 mm in length, and then trimmed to an oval shape so that the surface area was 180 mm ² . Then, a silicone tube having an inner diameter of 200 μm and an outer diameter of 300 μm was inserted between the double layers of the above-mentioned elliptical e-PTFE (expanded poly (tetrafluoroethylene)) membrane, and the silicone tube was fixed using a silicone adhesive. A part of the edge corresponding to the opposite side of the tube was sealed without using a silicone adhesive so that the outflow of the outflow was allowed. Then, a 5-0 prolene wick was inserted into the lumen of the fixed silicon tube and then pushed into the inner space of the membrane. This is to prevent the inside of the tube to prevent hypotony at the initial stage after surgery.

We performed glaucoma surgery in 30 patients with glaucoma in Samsung Medical Center ophthalmology department using the glaucoma treatment device.

Test Example 1: Device for treating glaucoma 1 year after surgery

Ahmed valve implant and Baerveldt study by ABC (Ahmed Baerveldt Comparison) Compare a one-year prognosis of an implant (Donald L. et al, Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up Ophthalmology 2011; 118..: 443-452) were used to compare the clinical outcomes of patients who underwent a 1-year follow-up after a microtube (glaucoma treatment) operation. The results are summarized in Table 1 below:

- Comparative Example 1
(Ahmed valve group) Comparative Example 2
(Baerveldt implant group) Example 1
(Fine tube group) Baseline - - - IOP (intraocular pressure) (mmHg) 31.2 ± 11.2 31.8 ± 12.5 35.7 ± 12.7 Glaucoma medication
(glaucoma medication) 3.4 ± 1.1 3.5 ± 1.1 2.6 ± 0.8 No. (% of baseline) 143 133 30 1 day - - - IOP (mmHg) 10.0 + 7.9 18.6 ± 13.7 12.0 + - 9.6 No. (% of baseline) 142 (99%) 130 (98%) 30 (100%) 1 week - - - IOP (mmHg) 10.6 ± 5.6 17.2 ± 12.0 16.1 + - 11.3 Glaucoma medication 0.2 ± 0.7 0.9 ± 1.4 0 No. (% of baseline) 140 (98%) 118 (89%) 30 (100%) 1 month - - - IOP (mmHg) 20.7 ± 9.7 18.0 + - 10.0 13.2 ± 6.6 Glaucoma medication 0.5 ± 1.0 1.3 ± 1.5 0.0 ± 0.2 No. (% of baseline) 139 (97%) 130 (98%) 30 (100%) 3 month - - - IOP (mmHg) 18.8 + - 8.3 16.7 ± 8.2 18.0 + - 7.3 Glaucoma medication 1.4 ± 1.3 1.2 ± 1.3 0.4 ± 0.6 No. (% of baseline) 133 (93%) 125 (94%) 30 (100%) 6 month - - - IOP (mmHg) 15.7 ± 5.3 14.8 ± 6.8 16.6 ± 3.2 Glaucoma medication 1.7 ± 1.4 1.3 ± 1.3 1.2 ± 0.8 No. (% of baseline) 131 (92%) 125 (94%) 30 (100%) 1 year - - - IOP (mmHg) 15.4 ± 5.5 13.2 ± 6.8 15.6 ± 3.2 Glaucoma medication 1.8 ± 1.3 1.5 ± 1.4 1.2 ± 0.8 No. (% of baseline) 132 (92%) 117 (88%) 28 (93%)

As can be seen from the above Table 1, Example 1 showed a similar pattern in terms of the degree of control of the glaucoma and the number of eye drops compared with Comparative Examples 1 and 2 as a whole.

Test Example 2: Comparison of Reasons for Treatment Failure

The causes of failure of surgery in Example 1 and Comparative Examples 1 and 2 are summarized in Table 2 below:

- Comparative Example 1
(Ahmed valve group) Comparative Example 2
(Baerveldt implant group) Example 1
(Fine tube group) Improper IOP adjustment without additional glaucoma surgery 9 (6%) 6 (5%) 0 Glaucoma reoperation 11 (8%) 1 (1%) 2 (7%) Transplantation for complications
(explantation for complication) 1 (1%) 3 (2%) 0 (0%) Persistent hypotony 0 (0%) 2 (2%) 0 (0%) Wide-angle disappearance 2 (1%) 6 (5%) 0 (0%) Sum 23 (16%) 18 (14%) 2 (7%)

Based on the above Table 2, in the conventional ABC study (Comparative Examples 1 and 2), intraocular pressure was not adjusted to 21 mmHg or more, explantation due to complications, reoperation within one year after the operation, In the case of fine tube, 2 patients (7 patients) underwent surgery for position adjustment because of poor intraocular pressure or poor tube position. %), The intraocular pressure was adjusted with or without intraocular pressure one year later.

Test Example 3: Comparison of the type and number of interventions administered to the patient after the operation

Table 3 below summarizes the procedures performed for patients after surgery. Frequent post-operative treatment is a burden to both the patient and the medical staff and is a factor for increasing postoperative complications.

- Comparative Example 1
(Ahmed valve group) Comparative Example 2
(Baerveldt implant group) Example 1
(Fine tube group) Front reshaping
(anterior chamber reformation) 9 (6%) 15 (11%) 0 (0%) Avastin injection
(NVG stratum) 0 (0%) 2 (1%) 0 (0%) Laser correction of blebs in slit lamps 2 (1%) 0 (0%) 0 (0%) Laser irisplasty (iridoplasty)
(Cause: tube iris contact) No record No record 2 (7%) Needling in the slit lamp 0 (0%) 1 (1%) 0 (0%) Total number of patients treated 10 (7%) 18 (14%) 2 (7%)

As shown in Table 3, an important difference between Example 1 (fine tube) and conventional implants (Comparative Examples 1 and 2) is that the posterior anterior chamber formation treatment is significantly less in Example 1 . This is because it is rare to fall into hypotony after surgery because of the small inner diameter of the fine tube of Example 1 and the role of the wick placed in it. Postoperative hypotony can lead to complications such as macular edema due to hypotony, and it can cause irreversible visual impairment if it lasts for a long time.

Test Example 4: Comparison of initial complications after surgery

Table 4 below compares the initial complications after surgery:

Complication Comparative Example 1
(Ahmed valve group) Comparative Example 2
(Baerveldt implant group) Example 1
(Fine tube group) Tube occlusion 3 (2%) 12 (9%) 2 (7%) Choroidal effusion
(choroidal effusion) 21 (15%) 13 (10%) 0 (0%) Choroidal hemorrhage
(suprachoroidal hemorrhage) 0 (0%) 2 (2%) 0 (0%) Stomatitis
(endophthalmitis) 0 (0%) 1 (1%) 1 (3.5%) Cystic macular edema
(cystoid macula edema) 8 (6%) 2 (2%) 0 (0%) Shallow front
(shallow anterior chamber) 27 (19%) 26 (20%) 0 (0%) Hypotony maculopathy
(hypotony maculopathy) 5 (3%) 3 (2%) 0 (0%) Diplopia 9 (6%) 7 (5%) 0 (0%) Corneal edema
(cornea edema) 17 (12%) 29 (22%) 3 (10%) Tube - Corneal Contact 7 (5%) 8 (6%) 0 (0%) Tube erosion
(tube erosion) 1 (1%) 1 (1%) 0 (0%) Front bleeding
(hyphema) 13 (9%) 22 (17%) 2 (7%) Vitreous hemorrhage
(vitreous hemorrhage) 2 (1%) 3 (2%) 0 (0%) Number of patients with early complications 61 (43%) 77 (58%) 8 (27%)

Choroidal effusion, shallow anterior chamber, and hypotony maculopathy are all complications associated with hypotony. As shown in Table 4 above, the operation of Example 1 (fine tube) I could hardly see the city. The complications that should be noted with this are diplopia and tube erosion, both due to the large volume of tubes and explants. If the conjunctiva is not enough, the conjunctiva should be covered with other parts of the conjunctiva or other person's sclera. do. In the case of the fine tube of Example 1 in which the volume of the tube and the explant is remarkably small, this complication can be reduced, which is a very important advantage.

Having described specific portions of the invention in detail, those skilled in the art will appreciate that these specific embodiments are merely preferred embodiments and that the scope of the present invention is not limited thereto. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

Claims (9)

Apparatus for treating ocular diseases induced by elevated intraocular pressure comprising:
(a) a foldable, thin membrane plate that is made of non-porous or low porosity polymer that accepts aqueous humor;
(b) a micro-tube having a length of 20-40 mm, an inner diameter of 130-230 [mu] m and an outer diameter of 250-400 [mu] m, which is connected to one end of the membrane plate and the other end is composed of an inner water outlet, a fine tube; And
(c) a core which is inserted through an inner water outlet of the micro-tube and is located to the inside of the membrane plate, and moves or removes the micro-tube before and after the outlet of the micro-tube to control the flow rate of the water.
The apparatus according to claim 1, wherein the eye disease is glaucoma.
The method of claim 2, wherein the glaucoma is selected from the group consisting of congenital glaucoma, traumatic glaucoma, glaucoma, hypertension, primary open right glaucoma, normal tension glaucoma, Glaucoma secondary to trauma to the eye, glaucoma secondary to the inflammation of the eye, glaucoma secondary to the drug, neovascular glaucoma or neovascular glaucoma Wherein the device is a secondary glaucoma caused by uveitis.
The non-porous or low porosity polymer of claim 1, wherein the non-porous or low porosity polymer is a fluoropolymer, silicone or SIBS [styrene-block-isobutylene-block-styrene] For treating eye diseases.
The method of claim 4, wherein the fluoropolymer is selected from the group consisting of polytetrafluoroethylene, expanded polytetrafluorethylene (e-PTFE), polyhexafluoropropylene (PHFP), and perfluoroalkoxy polymer Apparatus for treating eye diseases.
The apparatus of claim 1, wherein the membrane plate is 12-26 mm wide and 10-14 mm long.
The apparatus for treating an eye disease according to claim 1, wherein the micro-tube is made of a silicone material.
The apparatus for treating eye diseases according to claim 1, wherein the wick is a surgical non-absorbable surgical suture.
[Claim 9] The apparatus according to claim 8, wherein the surgical nonabsorbable surgical suture is made of nylon or prolene.

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