Canalicular balloon fixation stent

• US 5,318,513 A
• Filed: 09/24/1992
• Issued: 06/07/1994
• Est. Priority Date: 09/24/1992
• Status: Expired due to Fees

• Current Assignee: Martin L. Leib, Peter Michalos
• Original Assignee: Martin L. Leib, Peter Michalos
• Inventors: Michalos, Peter, Leib, Martin L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Wilkens, Frank
• Application Number:
  US07/950,925
• Time in Patent Office: 621 Days
• Field of Search: 604/8, 604/96, 604/98, 604/99, 604/101, 604/49, 604/54, 606/192-194, 606/196
• US Class Current: 604/8
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts

Abstract

A fixation stent and a method for using the stent to repair canalicular lacerations and to block fluid flow through a canalicular canal are provided The stent includes a flexible tube having a proximal end, a distal end, an inflatable portion in fluid communication with the distal end, and a plug for sealing and anchoring the proximal end within a body canal. In ophthalmic applications, the distal end of the stent is inserted into a punctum of an eyelid and is then urged through the associated canaliculus towards a lacrimal sac at the end of the canaliculus Once inside the lacrimal sac, the balloon is inflated to a diameter greater than the diameter of the canalicular canal, thereby anchoring and sealing the distal end of the stent within the lacrimal sac. A plug is secured within the proximal end of the stent subsequent to the inflation of the balloon, thereby serving to seal the proximal end of the stent The plug includes a portion with a diameter greater than the diameter of the punctum that rests on the margin of the eyelid, thereby anchoring the proximal end of the stent at the margin of the eyelid Although the stent is particularly suited to ophthalmological applications, it can be used in any narrow body canal.

Claims

1. A fixation stent for insertion in a lacrimal canal, the stent comprising:

a flexible tube having a proximal end, a distal end, and a hollow extending from the proximal end to the distal end, for transferring fluid therebetween;

an inflatable portion, in fluid communication with the distal end of the tube, for expandably receiving the fluid, said inflatable portion, when uninflated, being of dimensions small enough to fit through a lacrimal canal and, when inflated, being of dimensions large enough to prevent exit through said lacrimal canal; and

a plug secured to the proximal end of the tube, for anchoring the stent within the lacrimal canal and preventing the fluid from escaping via the proximal end of the tube.

2. The stent of claim 1 wherein the plug comprises:

a stem sized for secure insertion into the proximal end of the tube; and

a top, connected to the stem, having a diameter larger than the diameter of the body canal.

3. The stent of claim 1, wherein the plug is secured within the proximal end of the tube by friction.

4. The stent of claim 1 wherein the plug is secured in the proximal end by adhesive.

5. The stent of claim 1 wherein both the flexible tube and the plug are formed of an inert, non-toxic, medical grade polymer.

6. The stent of claim 5 wherein the medical grade polymer is selected from the group consisting of polysiloxane, silicone, and polymethylmethacrylate.

7. A bicanalicular fixation stent for treatment of medical conditions related to the eye, the stent comprising:

a first monocanalicular fixation stent including a first flexible tube having a first proximal end, a first distal end and a first inflatable portion in fluid communication with the first distal end;

a second monocanalicular fixation stent including a second flexible tube having a second proximal end, a second distal end and a second inflatable portion in fluid communication with the second distal end, wherein said first and second inflatable portions, when uninflated, are of dimensions small enough to fit, independently, through a lacrimal canal and, when inflated, are of dimensions large enough to prevent exit, independently, through said lacrimal canal; and

a connector having first and second opposite ends, the first end being secured to the first proximal end of the first stent, and the second end being secured to the second proximal end of the second stent, so as to seal the first and second proximal ends, and to anchor each of the stents at the margin of the eyelid.