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Methods and apparatus for sub-retinal catheterization

A retinal and catheter-based technology, applied in the macular area, can solve the problems of the delicate structure of the retina, the limited availability of interventional procedures, etc.

Inactive Publication Date: 2012-05-16
ISCI INTERVENTIONAL CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Interventional procedures targeting tissue beneath the sensory retina are difficult due to limited availability and the delicate structure of the retina, which is easily damaged during surgical procedures

Method used

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  • Methods and apparatus for sub-retinal catheterization
  • Methods and apparatus for sub-retinal catheterization
  • Methods and apparatus for sub-retinal catheterization

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 : Two enucleated rabbit eyes and human cadaver eyes were prepared for testing. The ciliary pars plana region of the sclera was dissected with an approximately 4 mm incision to expose the choroid. A series of round steel probes were used to apply pressure to the choroid and retina to determine if a specific size range of the atraumatic catheter tip would help prevent inadvertent penetration into the posterior chamber.

[0052] Round steel probes with tip diameters indicated in Table 1 were tested during dissection of the choroid to the subretinal space. Table 1 also shows the resulting effects observed.

[0053] Table 1. Probe Tip Diameters and Dissection Results

[0054] Probe Tip Diameter

[0055] Results from enucleated rabbit eyes and human cadaver eyes indicated that rounded tips less than 220 microns in diameter easily penetrated into the posterior chamber and provided no protection against penetration through the retina.

Embodiment 2

[0056] Example 2: Use of enucleated human cadaver eyes to determine the mechanical properties of stem atraumatic delivery in the subretinal space. Eyes were prepared in an "open sky" approach by dissecting the anterior segment of the globe at the level of the ciliary body and removing the lens. In the living eye, retinal tissue is connected to the RPE by interdigitation of cells and the RPE's fluid pump mechanism. Post-mortem, the retina is no longer strongly connected to the RPE, so a method was used to maintain retinal orientation during the experiment. A heavy fluid with a density of 1.707 Kg / L, perfluoromethylcyclopentane (Flutec PClC, F2 Chemicals LTD), was injected into the vitreous cavity to replace the vitreous humor and hold the retina in place, similar to that seen in retinal detachment repair use heavy fluids. A notch was cut in the eyeball down to the level of the anterior insertion of the retina to gain direct access to the retina via an internal route.

[00...

Embodiment 4

[0071] Example 4 : Internal and external access to the subretinal space was tested in a live animal study using a rabbit model. The study was performed under a protocol approved by the Institutional Animal Care and Use Committee (IACUC). Rabbits were anesthetized, draped and prepared for ophthalmic surgery per protocol.

[0072] To test the transintrinsic approach in rabbit eyes, two small pars plana incisions were made with an MVR knife for infusion and vitrectomy access, and a 23 gauge sclerostomy opening was placed in the ciliary In the pars plana, for the placement of tubular introducers and catheters. After performing a vitrectomy, a thin-walled introducer with a curved tip is placed through a 23-gauge opening. The introducer was constructed as in Example 2. The introducer is advanced across the eyeball and the distal tip is inserted into the peripheral retina to allow passage of the catheter into the subretinal space. The catheter tip is placed through the introduc...

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Abstract

Devices and methods are provided for access to the sub-retinal space that lies between the retina and the choroid in order to introduce therapies to the retina and more specifically to the sensory retina and RPE, particularly in the region of the macula. The devices comprise a catheter that incorporates advantageous size, flexibility and tip features to properly, accurately and atraumatically access the sub-retinal space. Ancillary devices to assist in placing catheters into the sub-retinal space are also provided. The catheter devices incorporate a lumen for delivery of therapeutic substances or devices into the eye.

Description

[0001] This application claims priority under 35 U.S.C. §119(e) and §§363-365 to U.S. Provisional Application No. 61 / 178,882, filed May 15, 2009, the disclosure of which is incorporated by reference for all purposes Incorporated into this article as a whole. Background technique [0002] There are many diseases and conditions that affect the retina and cause progressive reduction in visual acuity and eventually blindness. Detrimental consequences from disease processes or physiological defects can affect specific tissues of the retina, such as photoreceptors, ganglion cells, and retinal pigment epithelium (RPE). Diseases such as age-related macular degeneration, diabetic retinopathy, retinitis pigmentosa, Steiger's disease, and conditions such as macular hole, retinal detachment, epiretinal membrane, retinal, or choroidal vein occlusion can cause moderate to complete Vision loss. Many of these conditions are treated by systemic or intravitreal injection of agents, or via sur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M5/00
CPCA61F9/00727A61M5/00A61M25/01A61F9/008
Inventor S·R·康斯顿R·亚马莫托
Owner ISCI INTERVENTIONAL CORP
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