REDUCTION OF INTRAOCULAR PRESSURE IN THE EYE USING A TUBULAR CLIP

• US 20140052046A1
• Filed: 02/13/2013
• Published: 02/20/2014
• Est. Priority Date: 02/13/2012
• Status: Active Grant

• Current Assignee: O3 Optix LLC
• Original Assignee: Iridex Corporation
• Inventors: Peartree, Kenneth A., Feustel, Aaron, Buckely, Tim
• Granted Patent: US 9,241,831 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Drainage of aqueous from the anterior chamber of the eye can be facilitated by a malleable hollow clip or staple that can be formed to attach to ophthalmic tissue and provide intra-luminal flow of aqueous through the clip. In addition, the clip can be adjusted to modulate the outflow rate of aqueous, both during the initial surgical procedure as well as on a post-procedure basis. Furthermore, an instrument is described in which the forceps of the clip delivery device reside inside the lumen of hollow clip during deployment and manipulation. Features of an instrument are designed to secure the clip to the delivery forceps and prevent tissue blockage of the clip lumens. The clips may be color-matched to the underlying tissue for the purpose of camouflage and may carry pharmaceuticals.

Claims

1. A method for draining excess fluid from a region of a patient body, the region bordered by a tissue, the method comprising:

penetrating the tissue so as to advance an elongate leg of drain clip distally into the tissue;

engaging the tissue with a base of the drain clip;

deforming at least a portion of the leg of the advanced drain clip so that so that the base and the leg affix the drain clip to the tissue; and

passing the excess fluid from the region along a channel of the leg.

2. The method of claim 1, wherein the region comprises a volume of an eye of the patient, wherein the tissue comprises a tissue of the eye, and wherein the passing of the fluid along the channel mitigates excess intra ocular pressure of the eye.

3. The method of claim 1, wherein the leg comprises a tubular body having a proximal opening and a distal opening with a lumen therebetween, the channel comprising the lumen, wherein the leg is advanced distally with a deployment shaft disposed in the lumen so as to inhibit ingress of tissue therein and wherein the shaft is withdrawn proximally from the lumen so as to facilitate passing the fluid along the lumen.

4. The method of claim 1, wherein the shaft is included in a deployment assembly that releasably supports the clip while penetrating the tissue, the deployment assembly including a sharpened distal end extending distally of the draining clip so as to facilitate the penetrating of the tissue.

5. The method of claim 4, wherein the deployment assembly comprises an actuatable shaft extending along the leg, and wherein deforming of the leg is induced from outside the tissue by actuating the actuatable shaft so that the shaft bends a distal foot of the leg laterally to capture the tissue between the foot and the base.

6. The method of claim 5, wherein the actuatable shaft comprises a wire or shaft extending distally within the leg to a deformation body, wherein a proximal movement of the shaft pushes the deformation body laterally against the foot so as to deform the foot.

7. The method of claim 6, wherein the deformation body is included in the deployment assembly, and further comprising pulling the deformation body proximally through the draining clip, the pulling of the deformation body straightening the deformation body so as to leave the draining clip in the tissue when the deployment assembly is withdrawn from the patient.

8. The method of claim 1, wherein a plurality of legs of a draining clip system are advanced into the tissue, and wherein the base spans between first and a second legs.

9. A system for draining excess fluid from a region of a patient body, the region bordered by a tissue, the system comprising:

a draining clip having;

an elongate leg configured for advancing distally into the tissue, the leg having an channel extending therealong;

a base disposed adjacent a proximal end of the leg, the base orientable to engage the tissue; and

at least a portion of the leg of the advanced drain clip being deformable so that the base and the leg affix the drain clip to the tissue, and so as to pass the excess fluid from the region along the channel of the leg.

10. The system of claim 9, the region comprising a volume of an eye of the patient, the tissue comprising a tissue of the eye, wherein the drain clip is configured to pass the fluid along the channel so as to mitigate excess intra ocular pressure of the eye, the channel of the leg having an inner diameter of about 0.002″

-0.008″ and

the leg having an outer diameter of about 0.005″

-0.013″

.

11. The system of claim 9, wherein the leg comprises a tubular body having a proximal opening and a distal opening with a lumen therebetween, the channel comprising the lumen, wherein the leg is configured to be advanced distally with a deployment shaft of a deployment assembly disposed in the lumen so as to inhibit ingress of tissue therein, and wherein the shaft is configured to be withdrawn proximally from the lumen so as to facilitate passing the fluid along the lumen.

12. The system of claim 11, wherein the deployment assembly releasably supports the clip, the deployment assembly including a sharpened distal end extending distally of the draining clip so as to facilitate the penetrating of the tissue.

13. The system of claim 12, wherein the shaft of the deployment assembly comprises an actuatable shaft, and wherein actuating the actuatable shaft from outside the tissue deforms of the leg so that the shaft bends a distal foot of the leg laterally to capture the tissue between the foot and the base.

14. The system of claim 13, wherein the actuatable shaft comprises a wire or shaft extending distally within the lumen of the leg to a deformation body, wherein a proximal movement of the shaft pushes the deformation body laterally against the foot so as to deform the foot.

15. The system of claim 14, wherein the deformation body is included in the deployment assembly, and wherein the deformation body is configured to be pulled proximally through the draining clip so that the pulling of the deformation body straightens the deformation body so as to leave the draining clip in the tissue when the deployment assembly is withdrawn from the patient.

16. The system of claim 9, wherein the leg is included within a plurality of legs of the draining clip system, the legs configured to be advanced into the tissue so as to provide a plurality of parallel drainage paths, and wherein the base spans between first and a second leg of the plurality of legs.

18. The system of claim 9, wherein the leg is configured to accommodate an adjustment to the channel after deployment so as to provide for adjustable flow rate of fluid through the deployed drainage clip.

19. A method for utilizing a hollow and malleable clip, or staple, that can be affixed to a layer of tissue and provide a pathway for drainage through that tissue.

20. The method of claim 19, wherein tubular legs of the drainage clip can be loaded onto ends of deployment or forceps jaws, wherein the forceps jaws extend past the loaded clip such that sharpened forceps tips penetrating the tissue ahead of the clip, and wherein the forceps jaws block the lumens of the hollow clip in order to prevent unwanted ingress of tissue that could block and otherwise impair drainage through the clip.

21. The method of claim 19, further comprising using forceps jaws:

to re-acquire a lumen of the clip to adjust a position of the clip, or

to remove the clip, or

to provide an adjustable flow rate of fluid through the clip by changing the size of either in flow or out flow orifices on the clip, and further comprising communicating to the operator the closure position of the clip (and thus clip lumen orifice size and/or flow rate) by calibrating the deployment handle position to forceps jaw and clip position.

22. The method of claim 19, wherein the clip comprises a biocompatible malleable materials selected from among the group:

tantalum, gold, platinum, titanium, stainless steel, or plastic.

23. The method of claim 19 wherein pigmented clips, either through natural pigmentation of a base material of the clip or through a surface material, provide camouflage of the tip relative to the tissue.

24. The method of claim 19 wherein the clips is used to elute or administer pharmaceuticals.

25. An ophthalmological surgery clip comprising:

a clip body configured to engage a tissue of an eye;

a leg extending from the clip body to a distal end, the distal end configured for insertion into and through the tissue of the eye, the leg having a lumen extending between the clip body and the distal end so as to provide a drainage path for fluid through the tissue, the clip being configured for deformation so as to effect repositioning the distal end of the leg relative to the clip body such that the clip is retained by the tissue.