Ocular implant and methods for making and using same

• US 20050119737A1
• Filed: 06/01/2004
• Published: 06/02/2005
• Est. Priority Date: 01/12/2000
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Taylor, Jon B., Wandel, Thaddeus L., Mir, Leon, Morrill, Tim J., Mulhern, Margaret B., Bene, Eric A.
• Application Number:
  US10/857,452
• Publication Number:
  US 20050119737A1
• Time in Patent Office: Days
• US Class Current: 623/4.100
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0087 colour-coded
• 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

Abstract

An ocular implant device that is insertable into either the anterior or posterior chamber of the eye to drain aqueous humor and/or to introduce medications. The implant can include a substantially cylindrical body with a channel member that regulates the flow rate of aqueous humor from the anterior chamber or introduces medications into the posterior chamber, and simultaneously minimizes the ingress of microorganisms into the eye.

Claims

1-79. -79. (canceled)

80. An ocular implant for fluid communication with an anterior or posterior chamber of an eye, comprising:

a body having a proximal end and a distal end, said body extending from at least one of an anterior and posterior chamber to an outer surface of an eye;

a head positioned at said proximal end of said body for engagement against said outer surface of the eye;

a foot positioned at said distal end of said body for engagement within at least one of an anterior and posterior chamber; and

said body, said head and said foot being shaped and dimensioned to substantially prevent extrusion, intrusion and leakage.

81. An ocular implant as claimed in claim 80, wherein at least one of said body, said head and said foot is constructed of an ocular hydrogel having a dehydrated state and a hydrated state, silicone, polymethylmethacrylate, poly 2-hydroxyethylmethacrylate, hylauronic acid, a silicone/hydrogel combination, a silicone acrylic combination, fluorosilicone acrylate, ceramic, coral and stainless steel.

82. An ocular implant as claimed in claim 81, wherein:

said hydrated state provides at least one of a body, head and foot dimension that is approximately 10 to approximately 50 percent larger than said dehydrated state.

83. An ocular implant as claimed in claim 80, wherein:

said foot comprises a circular cross section and said body comprises a circular cross section; and

a ratio between a diameter of said foot circular cross section and a diameter of said body circular cross section is defined as,

foot circular cross section diameter/body circular cross section diameter, and comprises a value of between approximately 1.3 and approximately 3.00.

84. An ocular implant as claimed in claim 81, wherein:

said foot comprises a circular cross section to be inserted into an incision, said incision having a length; and

a ratio between said length of said incision and a diameter of said foot circular cross section is defined as,

incision length/foot circular cross section diameter, and comprises a value of between approximately 1.0 and approximately 1.3 in said dehydrated state.

85. An ocular implant as claimed in claim 81, wherein:

said foot comprises a circular cross section to be inserted into an incision, said incision having a length; and

a ratio between said length of said incision and a diameter of said foot circular cross section is defined as,

incision length/foot circular cross section diameter,

and comprises a value of between approximately 0.75 and approximately 1.0 in said hydrated state.

86. An ocular implant as claimed in claim 81, wherein:

said body comprises a circular cross section to be inserted into an incision, said incision having a length; and

a ratio between said length of said incision and a diameter of said body circular cross section is defined as,

incision length/body circular cross section diameter,

and comprises a value of between approximately 1.25 and approximately 2.0 in said hydrated state.

87. An ocular implant as claimed in claim 80, wherein said ocular implant comprises:

a foot diameter of between approximately 0.057 inches and approximately 0.065 inches; and

a body diameter of between approximately 0.029 inches and approximately 0.034 inches.

88. An ocular implant as claimed in claim 81, wherein said ocular implant comprises a body length of approximately 0.030 inches in said dehydrated state and a body length of approximately 0.035 inches in said hydrated state.

89. An ocular implant as claimed in claim 81, wherein said ocular implant comprises a body length of approximately 0.036 inches in said dehydrated state and a body length of approximately 0.042 inches in said hydrated state.

90. An ocular implant as claimed in claim 80, wherein said ocular implant comprises a body length of between approximately 0.0196 inches and approximately 0.0393 inches.

91. An ocular implant as claimed in claim 81, wherein:

said ocular implant is inserted in said dehydrated state, said dehydrated state providing said implant in a substantially rigid form; and

said ocular implant is hydrated after insertion, said hydrated state providing said implant in a substantially soft and pliable form.

92. An ocular implant as claimed in claim 80, wherein:

said head comprises a circular cross section and said body comprises a circular cross section; and

a ratio between a diameter of said head circular cross section and a diameter of said body circular cross section is defined as,

head circular cross section diameter/body circular cross section diameter, and comprises a value of approximately 1.62.

93. An ocular implant as claimed in claim 81, wherein:

said ocular implant includes a head diameter of approximately 0.047 inches in said dehydrated state and a foot diameter of approximately 0.057 inches in said dehydrated state; and

said ocular implant includes a head diameter of approximately 0.055 inches in said hydrated state and a foot diameter of approximately 0.065 inches in said hydrated state.

94. An ocular implant as claimed in claim 80, wherein said head comprises:

at least one of a contoured, an inclined and a flat surface to engage said outer surface of said eye.

95. An ocular implant as claimed in claim 80, further comprising:

said head disposed at a first angle relative to said body, wherein said first angle is configured for ocular implant insertion at a specific site including at least one of a clear cornea insertion site and a transscleral insertion site; and

said foot disposed substantially parallel to said head.

96. An ocular implant as claimed in claim 80, further comprising:

said body having a proximal and distal section, wherein said proximal section is disposed at a second angle relative to said distal section;

said head disposed at a third angle relative to said proximal section of said body; and

said foot disposed at a fourth angle relative to said distal section of said body, wherein said second, third and fourth angles are configured for ocular implant insertion at a specific site, including at least one of a clear cornea insertion site and a transscleral insertion site.

97. An ocular implant as claimed in claim 80, wherein at least one of said body, said head and said foot is coated with an antimicrobial agent, wherein said antimicrobial agent comprises at least one of an ionic metal compound, antibacterial polymer, organic compound and an inorganic compound.

98. An ocular implant as claimed in claim 80, wherein at least one of said body, said head and said foot is coated with at least one of a surgical adhesive, a fibrin-based glue, a marine adhesive protein and a synthetic polymeric adhesive.

99. An ocular implant as claimed in claim 80, wherein said body has a substantially noncircular cross-section.

100. An ocular implant as claimed in claim 80, wherein said foot is pliable to deflect and provide a reduced outside diameter during insertion within an incision, and to return to a nondeflected position after insertion to secure said foot within said incision.

101. An ocular implant as claimed in claim 80, wherein said foot is substantially rectangular and rotatable between a first position substantially parallel with an incision, and a second position substantially perpendicular with said incision, said rotation securing said rectangular foot within said incision.

102. An ocular implant as claimed in claim 80, wherein said head is provided with an access port for at least one of an injection and infusion of a desired substance into at least one of said anterior and posterior chamber.

103. An ocular implant as claimed in claim 102, wherein said access port comprises at least one of a substantially round opening and a slit opening.

104. An ocular implant as claimed in claim 102, wherein said desired substance comprises at least one of a immune response modifier, neuroprotectant, corticosteroid, angiostatic steroid, anti-glaucoma agent, anti-angiogentic compound, anti-biotic, anti-bacterial agent, anti-viral agent, anti-cancer agent, and an anti-inflammatory agent.

105. An ocular implant as claimed in claim 80, wherein at least one of said body, said head and said foot comprises at least one of a protrusion, a mechanical thread, a rough surface, a porous surface or material containing said desired substance for infusion into at least one of said anterior and posterior chamber, and a porous material to provide communication between said at least one of an anterior and posterior chamber and an outer surface of an eye.

106. An ocular implant as claimed in claim 80, wherein said body includes at least one channel to provide communication between said at least one of an anterior and posterior chamber and an outer surface of an eye.

107. An ocular implant as claimed in claim 106, wherein said head is provided with a membrane substantially covering said channel, wherein said membrane is constructed of a porous hydrogel material.

108. An ocular implant as claimed in claim 107, wherein said head is constructed to allow an epithelium membrane to grow and substantially cover said channel.

109. An ocular implant as claimed in claim 106, further comprising a flow restrictor disposed within said channel, wherein said flow restrictor comprises at least one of an antimicrobial element, a micro-device element and a filter element.

110. An ocular implant as claimed in claim 109, wherein said antimicrobial element comprises at least one of an ionic metal compound, antibacterial polymer, bacteria intolerant metal, bacteria intolerant spheres, silver fiber members, silver plate members, an antimicrobial filter, diatomic powder, a cast porous matrix, an antimicrobial organic compound including alkyl trypsin, biguanide, triclosan and chlorhexidine, and an antimicrobial inorganic compound including quaternary ammonium salt and metal oxide, wherein said bacteria intolerant spheres comprise silver ion time release impregnated glass soluble spheres.

111. An ocular implant as claimed in claim 109, wherein said micro-device element comprises a micro-mechanical pump.

112. An ocular implant as claimed in claim 109, wherein said filter element comprises at least one of a hollow fiber filter, capillary filter, a hydrogel filter and a porous filter.

113. An ocular implant as claimed in claim 112, wherein said filter element is provided to allow an infusion of a desired substance into at least one of said anterior and posterior chamber.

114. An ocular implant as claimed in claim 112, wherein said filter element comprises a plurality of said filters arranged in a predetermined order.

115. An ocular implant as claimed in claim 109, wherein said filter element comprises at least one of a silicone, polymethylmethacrylate, poly 2-hydroxyethylmethacrylate, hylauronic acid, a silicone/hydrogel combination, a silicone acrylic combination, fluorosilicone acrylate, ceramic, coral, titanium and stainless steel.

116. An ocular implant as claimed in claim 112, wherein said hollow fiber filter comprises:

a base having at least one fluid communication opening; and

at least one fiber extending from said fluid communication opening.

117. An ocular implant as claimed in claim 116, wherein said fiber comprises:

a fiber body having a substantially hollow center closed at one end of said fiber body and open at an opposite end of said body; and

said fiber body comprising a substantially porous material for providing fluid communication between an outer surface of said fiber body and said hollow center, wherein said porous material comprises a gradient of pore sizes between an outer surface of said fiber body and said hollow center.

118. An ocular implant as claimed in claim 112, wherein said capillary filter comprises a plurality of capillary tubes extending between distal and proximal ends of said capillary filter.

119. An ocular implant as claimed in claim 109, wherein said flow restrictor is integral with at least one of said head, said body and said foot.

120. An ocular implant as claimed in claim 109, wherein said flow restrictor is replaceable.

121. An ocular implant as claimed in claim 106, further comprising a valve disposed within said channel, wherein said valve comprises at least one of a flap member, a poppit valve, a Vernay valve, a duck-bill valve, an umbrella valve, a pressure cracking valve and a dome-over valve.

122. A method for placing an ocular implant into fluid communication with an anterior or posterior chamber of an eye, comprising:

creating an incision at an insertion site;

inserting an ocular hydrogel implant at said insertion site in a dehydrated state, said implant comprising;

a body with first and second ends, said body having hydrated and dehydrated states;

a head positioned at said first end of said body for engagement against said outer surface of said eye, said head having hydrated and dehydrated states;

a foot positioned at said second end of said body for engagement within at least one of an anterior and posterior chamber of said eye, said foot having hydrated and dehydrated states,

said body, said head and said foot being shaped and dimensioned to substantially prevent extrusion, intrusion and leakage in said hydrated state; and

hydrating at least one of said body, said head and said foot, to substantially prevent extrusion of said implant from said insertion site, intrusion of said implant into said insertion site and leakage from said insertion site.

123. A method for placing an ocular implant as claimed in claim 122, wherein:

said hydrated state provides at least one of a body, head and foot dimension that is approximately 10 to approximately 50 percent larger than said dehydrated state.

124. A method for placing an ocular implant as claimed in claim 122, further comprising:

providing a ratio between a diameter of said foot circular cross section and a diameter of said body circular cross section that is defined as,

foot circular cross section diameter/body circular cross section diameter, and comprises a value of between approximately 1.3 and approximately 3.00 in said hydrated state.

125. A method for placing an ocular implant as claimed in claim 122, further comprising:

providing a ratio between a length of said incision and a diameter of said foot circular cross section that is defined as,

incision length/foot circular cross section diameter, and comprises a value of between approximately 0.75 and approximately 1.0 in said hydrated state.

126. A method for placing an ocular implant as claimed in claim 122, wherein:

providing a ratio between a length of said incision and a diameter of said body circular cross section that is defined as,

incision length/body circular cross section diameter,

and comprises a value of between approximately 1.25 and approximately 2.0 in said hydrated state.

127. A method for manufacturing a corneal implant, comprising:

machining a shunt from at least one of an ocular hydrogel in a dehydrated state to provide a body having a proximal end and a distal end, a head positioned at said proximal end of said body, and a foot positioned at said distal end of said body; and

said body, said head and said foot being shaped and dimensioned to substantially prevent extrusion, intrusion and leakage when transitioned from said dehydrated state to a hydrated state.

128. A method for manufacturing a corneal implant as claimed in claim 127, further comprising:

machining said shunt to include a body having at least one channel to provide communication between at least one of an anterior and posterior chamber and an outer surface of an eye; and

disposing at least one of an antimicrobial element, a micro-device element and a filter element within said channel.

129. A method for manufacturing a corneal implant hydrogel housing, comprising:

casting a monomer mixture comprising at least one of a HEMA, methacrylic acid and dimethacrylate crosslinker material into a mold, wherein said mold comprises a silicone mold;

curing said monomer mixture to create a hydrogel rod, wherein said curing comprises at least one heat-curing operation;

de-molding and conditioning said rod under an elevated temperature; and

machining said rod into a shunt casing to provide a body having a proximal end and a distal end, a head positioned at said proximal end of said body, and a foot positioned at said distal end of said body, wherein said body, said head and said foot have a shape and dimension to substantially prevent extrusion, intrusion and leakage.

130. A method for manufacturing a corneal implant as claimed in claim 129, wherein said machining step further comprises:

machining said shunt to include at least one channel within said body to provide communication between at least one of an anterior and posterior chamber and an outer surface of an eye; and

disposing at least one of an antimicrobial element, a micro-device element and a filter element within said channel.