Shunt valve and therapeutic delivery system for treatment of glaucoma and methods and apparatus for its installation
First Claim
1. The combination comprising hole forming means for forming a hole in an elastic membrane separating a high pressure chamber and a low pressure chamber in the body of a patient, hollow shunt means removably carried by the hole forming means for being transported therewith and for being inserted into said hole and elastically engaged with said elastic membrane to establish communication between said high pressure chamber and said low pressure chamber, and fluid control means carried by said shunt means for controlling flow of fluid through the shunt means from the high pressure chamber to the low pressure chamber after the shunt means has been inserted into said hole and the hole forming means has been removed from the shunt means.
1 Assignment
0 Petitions
Accused Products
Abstract
A shunt valve for treatment of glaucoma in the form of a hollow tubular body insertable into a hole formed in the sclera and provided with retaining shoulders that hold the tubular body in place against fore and aft movement. The valve is carried on and transported by a tool at the front end of which projects a cutting member. The cutting member is driven from an energy source under the control of an operator to form a hole in the sclera after which the valve is displaced axially from the tool along a straight line into the hole coaxially thereof. A porous inflatable balloon can be carried by the valve or installed therein subsequent to the implantation of the valve in the sclera to control drainage through the valve. Medicaments and the like can be supplied with the inflatable balloon. The cutting member can be a rototrephine or a laser cutter.
399 Citations
54 Claims
- 1. The combination comprising hole forming means for forming a hole in an elastic membrane separating a high pressure chamber and a low pressure chamber in the body of a patient, hollow shunt means removably carried by the hole forming means for being transported therewith and for being inserted into said hole and elastically engaged with said elastic membrane to establish communication between said high pressure chamber and said low pressure chamber, and fluid control means carried by said shunt means for controlling flow of fluid through the shunt means from the high pressure chamber to the low pressure chamber after the shunt means has been inserted into said hole and the hole forming means has been removed from the shunt means.
- 8. The combination comprising hole forming means for forming a hole in an elastic membrane separating a high pressure chamber and a low pressure chamber in the body of a patient, said hole forming means including an instrument body, an energy source, cutting means on said body operated by said energy source for forming the hole in the membrane, and operator controlled switch means operatively associated with said instrument body for being operated by an operator for selectively connecting and disconnecting said cutting means and said energy source, and hollow shunt means removably carried with the cutting means for being inserted into said hole and elastically engaged with said elastic membrane to establish communication between said high pressure chamber and said low pressure chamber.
- 19. A shunt for use in the body of a patient for establishing communication between a high pressure chamber and a low pressure chamber separated by an elastic membrane, said shunt comprising a hollow tubular body insertable into a hole formed in an elastic membrane separating a high pressure chamber and a low pressure chamber, said tubular body having an outer surface and including means defining first and second spaced shoulders at said outer surface for forming a space between said shoulders of a size for engaging said elastic membrane at opposite surfaces of said membrane around said hole for maintaining said tubular body in said hole, said tubular body having a bore which establishes communication between said chambers when the tubular body is in said hole and means, including a therapeutic agent, in said bore in said tubular body for being distributed into the low pressure chamber when said tubular body is installed in the hole in said elastic membrane.
- 21. A shunt for use in the body of a patient for establishing communication between a high pressure chamber and a low pressure chamber separated by an elastic membrane, said shunt comprising a hollow tubular body insertable into a hole formed in an elastic membrane separating a high pressure chamber and a low pressure chamber, said tubular body having an outer surface and including means defining first and second spaced shoulders at said outer surface for forming a space between said shoulders of a size for engaging said elastic membrane at opposite surfaces of said membrane around said hole for maintaining said tubular body in said hole, said tubular body having a bore which establishes communication between said chambers when the tubular body is in said hole, wherein said hollow tubular body has a front end insertable into the hole in the elastic body for penetration into one of said chambers for communication therewith and a rear end which opens into the other of said chambers for communication therewith, and a tapered portion on said hollow tubular body which increases in diametrical extent from front to rear of said tubular body, said tapered portion having a rearmost surface constituting one of said shoulders.
- 26. A shunt for use in the body of a patient for establishing communication between a high pressure chamber and a low pressure chamber separated by an elastic membrane, said shunt comprising a hollow tubular body insertable into a hole formed in an elastic membrane separating a high pressure chamber and a low pressure chamber, said tubular body having an outer surface and including means defining first and second spaced shoulders at said outer surface for forming a space between said shoulders of a size for engaging said elastic membrane at opposite surfaces of said membrane around said hole for maintaining said tubular body in said hole, said tubular body having a bore which establishes communication between said chambers when the tubular body is in said hole and means coupled to said tubular body for projection from said front end into said one chamber to control fluid flow from the high pressure chamber to the low pressure chamber.
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31. A shunt valve for installation into a hole in the sclera to treat glaucoma, said shunt valve comprising a tubular body having posterior and anterior ends and including radial projections extending longitudinally along said body and defining an annular gap therebetween of a dimension to engage the sclera around a hole therein into which the tubular body is inserted, said tubular body being insertable into said hole posterior end first, one of said radial projections being tapered to increase in radial extent in a direction from the posterior end of the tubular body towards the anterior end of the tubular body.
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32. A method of providing controlled communication in the body of a patient between a high pressure fluid chamber and a low pressure fluid chamber separated by an elastic membrane, said method comprising forming a hole in an elastic membrane separating a high pressure fluid chamber and a low pressure fluid chamber in the body of a patient,
inserting a hollow shunt into said hole, engaging said shunt with the elastic membrane when said shunt is inserted into said hole so that said shunt is retained by said elastic member, and providing communication between the high and low pressure chambers through said shunt for fluid flow from the high pressure chamber to the low pressure chamber, and controlling the flow of fluid through said shunt from said high pressure chamber to said low pressure chamber to regulate rate of fluid flow between said chambers.
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44. A method of relieving intraocular pressure in the anterior chamber of the eye comprising:
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inserting, from outside the eye, a cutting tool into the anterior chamber of the eye, removably supporting a hollow shunt on the tool so that the shunt is carried with the tool into the anterior chamber, forming a hole with said cutting tool in the sclera in a region thereof separating said anterior chamber and the subconjunctival space of the eye, the subconjunctival space being at a lower pressure than that in the anterior chamber, axially displacing the shunt from the tool into the hole coaxially with the latter, retaining said shunt in the hole by the sclera, and providing communication between the anterior chamber and the subconjunctival space through said shunt whereby to relieve pressure in the anterior chamber wherein said displacing of said shunt is effected in a straight line.
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45. A method of relieving intraocular pressure in the anterior chamber of the eye comprising:
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inserting, from outside the eye, a cutting tool into the anterior chamber of the eye, removably supporting a hollow shunt on the tool so that the shunt is carried with the tool into the anterior chamber, forming a hole with said cutting tool in the sclera in a region thereof separating said anterior chamber and the subconjunctival space of the eye, the subconjunctival space being at a lower pressure than that in the anterior chamber, axially displacing the shunt from the tool into the hole coaxially with the latter, retaining said shunt in the hole by the sclera, and providing communication between the anterior chamber and the subconjunctival space through said shunt whereby to relieve pressure in the anterior chamber and controlling communication between the anterior chamber and the subconjunctival space by disposing a porous body in a flow path of fluid from the anterior chamber to the subconjunctival space via said shunt. - View Dependent Claims (46, 47, 48, 49, 50)
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- 51. The combination comprising hole forming means for forming a hole in an elastic membrane separating a high pressure chamber and a low pressure chamber in the body of a patient, hollow shunt means removably carried by the hole forming means for being transported therewith and for being inserted into said hole and elastically engaged with said elastic membrane to establish communication between said high pressure chamber and said low pressure chamber, and means carried by said shunt means for releasing a therapeutic substance into said low pressure chamber.
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54. A shunt for use in the body of a patient for establishing communication between a high pressure chamber and a low pressure chamber separated by an elastic membrane, said shunt comprising a hollow tubular body insertable into a hole formed in an elastic membrance separating a high pressure chamber and a low pressure chamber, said tubular body having an outer surface and including means defining first and second spaced shoulders at said outer surface for forming a space between said shoulders of a size for engaging said elastic membrane at opposite surfaces of said membrane around said hole for maintaining said tubular body in said hole, said tubular body having a bore which establishes communication between said chambers when the tubular body is in said hole, said shunt relieving intraocular pressure in the eye of the patient, said high pressure chamber being the anterior chamber of the eye, said low pressure chamber being the subconjunctival space of the eye, and said elastic membrane being the sclera of the eye, said anterior chamber and subconjunctival space containing aqueous humor, said space defined by said shoulders at the outer surface of the tubular body being dimensioned to engage the sclera around said hole for retention of the tubular body by the sclera without suturing, wherein said tubular body is dissolvable over time in aqueous humor.
Specification