Enhanced surface implant and method of manufacture
First Claim
1. An improved implantable device for implantation in humans having an outer membrane comprising:
- a) an enhanced, random sculptured, undulating, irregular, substantially smooth outer membrane surface of smoothly transitioned peaks, valleys, slopes and terraces without substantial indentations or interstices for providing device anchoring in the human body with minimal human-implantable device interface encapsulation, capsular contraction, fibrous capsule generation, trauma and infection, wherein said outer membrane surface is comprised of stacked particles being substantially tetrahedral in shape.
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Accused Products
Abstract
An implantable body including an outer membrane forming an enclosure for receiving a filler material. The surface of the outer membrane is characterized by a random distribution of peaks separated by valleys. The peaks and valleys are separated by gradual contoured slopes with a smooth transition between the peaks and valleys which are substantially free from indentation. The enhanced surface provides improved anchoring of the implant, yet reduces host reaction. The enhanced surface is formed by depositing a distribution of cured polymeric particles on an uncured tacky surface. This intermediate surface is then cured, followed by application of a layer of uncured elastomeric material. The entire surface is then cured to form the enhanced surface.
149 Citations
32 Claims
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1. An improved implantable device for implantation in humans having an outer membrane comprising:
a) an enhanced, random sculptured, undulating, irregular, substantially smooth outer membrane surface of smoothly transitioned peaks, valleys, slopes and terraces without substantial indentations or interstices for providing device anchoring in the human body with minimal human-implantable device interface encapsulation, capsular contraction, fibrous capsule generation, trauma and infection, wherein said outer membrane surface is comprised of stacked particles being substantially tetrahedral in shape. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. An improved implantable device for implantation in humans having a outer membrane comprising:
a) an enhanced, random, sculptured, undulating, irregular, substantially smooth outer membrane surface of smoothly transitioned peaks and valleys for providing device anchoring in the human with minimal human-implantable device interface encapsulation, capsular contraction, fibrous capsule generation, trauma and infection, wherein said peaks are comprised of particles being substantially tetrahedral in shape and being spaced about 600 μ
m.- View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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18. An improved implantable body for implantation in humans comprising:
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a) a soft, flexible outer membrane forming an enclosure for receiving a filler material; and b) an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes and terraces without interstices and substantial indentations disposed over at least a portion of said outer membrane, said undulating surface formed by; i) providing an elastomeric material suitable for use as an implant, having a tacky surface; ii) depositing a random distribution of cured polymeric particles which stack on one another on said tacky surface to form an intermediate textured surface, said particles being constructed of silicone and having an average diameter in a range of 300 μ
m to 600 μ
m;iii) curing said intermediate textured surface; iv) applying a layer of uncured elastomeric material over said intermediate textured surface; and v) curing said intermediate textured surface having said applied layer of uncured elastomeric material for forming said undulating textured surface. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. An improved implantable body for implantation in humans comprising:
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a) a soft, flexible outer membrane forming an enclosure for receiving a filler material; and b) an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes and terraces without interstices and substantial indentations disposed over at least a portion of said outer membrane, said undulating surface formed by; i) providing an elastomeric material suitable for use as an implant, having a tacky surface; ii) depositing a random distribution of cured polymeric particles which stack on one another on said tacky surface to form an intermediate textured surface, said particles being constructed of silicone and being substantially tetrahedral in shape; iii) curing said intermediate textured surface; iv) applying a layer of uncured elastomeric material over said intermediate textured surface; and v) curing said intermediate textured surface having said applied layer of uncured elastomeric material for forming said undulating textured surface.
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32. An improved implantable device for implantation in humans having an outer membrane comprising:
a) an enhanced, random sculptured, undulating, irregular, substantially smooth outer membrane surface of smoothly transitioned peaks, valleys, slopes and terraces without substantial indentations or interstices for providing device anchoring in the human body with minimal human-implantable device interface encapsulation, capsular contraction, fibrous capsule generation, trauma and infection, wherein said enhanced surface is comprised of stacked particles having an average diameter in a range of 300 μ
m to 600 μ
m and wherein said particles are substantially tetrahedral in shape.
Specification