# US 2023/0054622 A1 · Delivery aids for glaucoma shunts

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- Number: US 2023/0054622 A1
- Document ID: US20230054622A1
- Status: Published application
- Kind: A1
- Application number: 17/979,959
- Filed: 2022-11-03
- Published: 2023-02-23
- Earliest claimed: 2017-03-17
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Peter J. Roeber; Jeffrey C. Towler
- Web page: https://patentgrep.com/patent/US20230054622A1

## CPC

- A61F 9/00781: {Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment (drainage implants in general A61M27/002)}
- A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)}
- A61L 31/146: {Porous materials, e.g. foams or sponges}
- 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})
- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/0023: differing in porosity
- A61F 2250/0051: differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
- A61F 2250/0059: temporary
- A61L 2430/16: for reconstruction of eye parts, e.g. intraocular lens, cornea
- 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)}
- A61M 2205/04: implanted
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3341: stabilising pressure or flow to avoid excessive variation
- A61M 2210/0612: Eyes
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Glaucoma treatment systems are disclosed. In various example, the glaucoma treatment systems include a body and a fluid conduit configured to facilitate an evacuation of fluid, such as aqueous humor, from a fluid-filled body cavity, such as an anterior chamber of an eye. In some examples, the fluid conduit is soft and compliant, and the glaucoma treatment system includes one or more stiffening members coupled with the fluid conduit to temporarily stiffen the fluid conduit and help aid in the delivery of the glaucoma treatment device. In some examples, the stiffening members are removable from the fluid conduit after the glaucoma treatment system has been implanted.

## Claims

### Claim 1

A glaucoma drainage system comprising:
a body;
a fluid conduit in fluid communication with the body and including a first conduit end, a second conduit end, and a lumen, the first conduit end being positionable within a fluid-filled body cavity of a biological tissue, and the second conduit end being positionable outside of the fluid-filled body cavity such that a fluid from the fluid-filled body cavity is transferrable through the lumen of the fluid conduit to the body; and
a stiffening member removably coupled with an inner surface of the lumen of the fluid conduit, the stiffening member being positioned within the lumen and extending a first axial length of the fluid conduit,
wherein a portion of the stiffening member extending within the lumen of the fluid conduit forms a helical coil that unravels upon an application of tension to an end portion of the helical coil or
wherein the stiffening member increases to a second axial length upon an application of tension to an end portion of the stiffening member, the second axial length being larger than the first axial length.

### Claim 2 (depends on 1)

The system of claim 1, wherein the stiffening member and the fluid conduit, in combination, form an assembly, and wherein at least one of a column strength, a lateral stiffness, and a hoop strength of the assembly exceeds a column strength, a lateral stiffness, and a hoop strength of the fluid conduit, respectively.

### Claim 3 (depends on 2)

The system of claim 2, wherein the stiffening member includes one or more fibers.

### Claim 4 (depends on 2)

The system of claim 2, wherein the stiffening member includes one or more wires.

### Claim 5 (depends on 2)

The system of claim 2, wherein the helical coil includes a plurality of adjacent loops, the plurality of adjacent loops configured to increase hoop strength of the fluid conduit.

### Claim 6 (depends on 1)

The system of claim 1, wherein the end portion of the stiffening member juts from one of the first and second conduit ends to be accessible during an implantation procedure.

### Claim 7 (depends on 1)

The system of claim 1, wherein the stiffening member is a first stiffening member, the system further comprising a second stiffening member removably coupled with the fluid conduit, wherein the second stiffening member extends through a sidewall of the fluid conduit such that a first portion of the second stiffening member extends within the lumen of the fluid conduit and such that a second portion of the second stiffening member extends exterior to the fluid conduit along the sidewall of the fluid conduit, the second portion of the second stiffening member being accessible during an implantation procedure.

### Claim 8 (depends on 7)

The system of claim 7, wherein a second end of the second stiffening member extends from one of the first and second conduit ends such that the second end of the stiffening member is accessible during an implantation procedure.

### Claim 9 (depends on 1)

The system of claim 1, wherein the fluid conduit comprises expanded polytetrafluoroethylene.

### Claim 10 (depends on 1)

The system of claim 1, wherein the fluid-filled body cavity is an anterior chamber of an eye and the fluid is aqueous humor, and wherein the glaucoma drainage system is configured to regulate an intraocular pressure of a patient's eye when implanted.

### Claim 11 (depends on 1)

The glaucoma drainage system of claim 1, wherein the helical coil includes a plurality of adjacent windings, the plurality of adjacent windings configured to unravel progressively in response to an application of tension to the stiffening member.

### Claim 12

A method comprising:
arranging a stiffening member within an inner surface of a lumen of a tube, the lumen extending a length of the tube, the tube in fluid communication with a body, the stiffening member being removable from the lumen of the tube, the stiffening member and the tube forming an assembly, wherein a column strength of the assembly exceeds a column strength of the tube, wherein at least a portion of the stiffening member within the lumen of the tube forms a helical coil; and
removing the stiffening member by either unraveling a portion of the helical coil by applying a tension to an end portion of the helical coil or applying tension to an end portion of the stiffening member to increase an axial length of a stiffening member.

### Claim 13 (depends on 12)

The method of claim 12, wherein unraveling a portion of the helical coil by applying a tension to an end portion of the helical coil facilitates removal of the stiffening member from the lumen of the tube.

### Claim 14 (depends on 12)

The method of claim 12, wherein a lateral stiffness of the assembly exceeds a lateral stiffness of the tube, and a hoop strength of the assembly exceeds a hoop strength of the tube.

### Claim 15 (depends on 12)

The method of claim 12, wherein the stiffening member is a first stiffening member, the method further comprising arranging a second stiffening member within the lumen of the tube such that the second stiffening member extends through a sidewall of the tube, such that a first portion of the second stiffening member extends within the lumen of the tube and such that a second portion of the second stiffening member extends exterior to the tube along the sidewall of the tube, the second portion of the second stiffening member being accessible during an implantation procedure.

### Claim 16 (depends on 15)

The method of claim 15, wherein the first and second stiffening members are independently removable from the lumen of the tube.

### Claim 17

A method of constructing a glaucoma drainage device, the method comprising:
arranging a stiffening member within an inner surface of a lumen of a tube, the lumen extending a length of the tube, the tube in fluid communication with a body, the stiffening member being removable from the lumen of the tube, the stiffening member and the tube forming an assembly, wherein a column strength of the assembly exceeds a column strength of the tube, wherein at least a portion of the stiffening member within the lumen of the tube forms a helical coil;
winding an elongate element about a mandrel to form a coil about the mandrel, thereby forming a coiled elongate element;
forming the tube about the coiled elongate element such that the coiled elongate element is disposed within the lumen of the tube and such that the coiled elongate element is removable from the lumen of the tube; and
removing the mandrel such that the elongate element remains coiled within the lumen of the tube.

### Claim 18 (depends on 17)

The method of claim 17, wherein forming the tube about the coiled elongate element includes wrapping a film about the coiled elongate element.

### Claim 19 (depends on 18)

The method of claim 18, wherein the film is a tape.

### Claim 20 (depends on 17)

The method of claim 17, wherein the coiled elongate element is a fluoropolymer fiber or expanded polytetrafluoroethylene.