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US4298002A Expired / Lapsed US ⏱️ 0.0 years remaining

Porous hydrophilic materials, chambers therefrom, and devices comprising such chambers and biologically active tissue and methods of preparation

Assignee: National Patent Development Corp
•
Filing: 1979-09-10
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Granted: 1981-11-03
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Expires: 1999-09-10
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Abstract

Abstract Hydrophilic polymeric chambers for encapsulating biologically active tissue and methods for their preparation. The tissue refers to those essential cellular components of a particular organ that is capable of receiving, modifying or secreting hormones. A device comprising such chamber and such tissue is fabricated and implanted in a living body so that said tissue is permitted normal function without being rejected by the host's immunological system. The viability of the tissue in the device is maintained by a correlation of factors including pore size and membrane thickness of the hydrophilic chamber. To maintain the viability of the tissue, the implanted device allows the inflow of essential nutrients and gases, and outflow of metabolites and products while simultaneously excluding the ingress of cellular components of the host's immunological system.

Inventors

  • 👤 Samuel H. Ronel
  • 👤 Mark J. D'Andrea
  • 👤 William H. Dobelle
  • 👤 Gregory F. Klomp
  • 👤 Hiroshi Hashiguchi

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 22:55
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0092; A61K9/0012; A61K9/0019; A61K9/0024; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1635; A61K9/20; A61K9/2004; A61K9/2022; A61K9/2027; A61L; A61L27/00; A61L27/50; A61L27/54; A61L2300/00; A61L2300/20; A61L2300/30; A61L2300/40; A61L2300/43; Y; Y10; Y10T; Y10T428/00; Y10T428/13

Claims Analysis

Total Claims: 44
Claim 1
Independent Claim 248 words
A synthetic, hydrophilic, polymeric material of a polymer of at least one monomer from the group consisting of a monoalkylene glycol monoester of methacrylic acid, a polyalkylene glycol monester of methacrylic acid, a monoalkylene glycol monoester of crylic acid, a polyalkylene glycol monoester, a N-alkyl substituted acrylamide, a N,N-dialkyl substituted acrylamide, a N-alkyl substituted methacrylamide, a N,N-dialkyl substituted methacrylamide, N-vinylpyrrolidone, an alkyl substituted N-vinylpyrrolidone, and vicinal epoxy alkyl 2-alkenoate, characterized by: water-insolubility; water-swellability; biological inertness; non-toxicity to and compatibility with living tissue; retention of structural integrity over long periods of time in contact with body fluids; a water-uptake capability when in osmotic equilibrium with water of from 5 to 4000 weight percent based on the weight of said hydrophilic material to form a hydrogel; an ultimate strength of about 3 g/mm 2 to 200 g/mm 2 , an initial tear strength of 0.1 g/mm 2 to 20 g/mm 2 , and a progagation tear strength of 0.5 g/mm to 10 g/mm; and 3-dimensional, reticulum-like porosity in which at least about 75 percent of the remaining pores, as determined under a scanning electron microscope, are characterized by an average diameter, not exceeding about 10 microns and in which below about 25 percent of the pores are characterized by an average diameter generally sufficiently small so as to prevent an immune rejection when said hydrophilic material containing biologically active tissue therein is in contact with living tissue environment, the geometry of such permitting the ingress or egress of a steroid.
Claim 2
Dependent Claim 248 words
A synthetic, hydrophilic, polymeric material of a polymer of at least one monomer from the group consisting of a monoalkylene glycol monoester of methacrylic acid, a polyalkylene glycol monester of methacrylic acid, a monoalkylene glycol monoester of crylic acid, a polyalkylene glycol monoester, a N-alkyl substituted acrylamide, a N,N-dialkyl substituted acrylamide, a N-alkyl substituted methacrylamide, a N,N-dialkyl substituted methacrylamide, N-vinylpyrrolidone, an alkyl substituted N-vinylpyrrolidone, and vicinal epoxy alkyl 2-alkenoate, characterized by: water-insolubility; water-swellability; biological inertness; non-toxicity to and compatibility with living tissue; retention of structural integrity over long periods of time in contact with body fluids; a water-uptake capability when in osmotic equilibrium with water of from 5 to 4000 weight percent based on the weight of said hydrophilic material to form a hydrogel; an ultimate strength of about 3 g/mm 2 to 200 g/mm 2 , an initial tear strength of 0.1 g/mm 2 to 20 g/mm 2 , and a progagation tear strength of 0.5 g/mm to 10 g/mm; and 3-dimensional, reticulum-like porosity in which at least about 75 percent of the remaining pores, as determined under a scanning electron microscope, are characterized by an average diameter, not exceeding about 10 microns and in which below about 25 percent of the pores are characterized by an average diameter generally sufficiently small so as to prevent an immune rejection when said hydrophilic material containing biologically active tissue therein is in contact with living tissue environment, the geometry of such permitting the ingress or egress of a steroid.
Claim 3
Dependent Claim 26 words
The hydrophilic material as claimed in claim 1 wherein below about 25 percent of the average diameter of said remaining pores does not exceed about 20μ.
Claim 4
Dependent Claim 23 words
The hydrophilic material as claimed in claim 2 in which its thickness is in the range of from about 100μ to about 1000μ.
Claim 5
Dependent Claim 22 words
The hydrophilic material as claimed in claim 1 characterized by a water uptake capability of about 20 to about 2000 weight percent.
Claim 6
Dependent Claim 23 words
The hydrophilic material as claimed in claim 1 in which its thickness is in the range of from about 30μ to about 1000μ.
Claim 7
Dependent Claim 31 words
The hydrophilic material as claimed in claim 5 in equilibrium with living tissue environment and characterized by the non-ingress of viable cellular entities therein and the egress of viable hormones therefrom.
Claim 8
Dependent Claim 28 words
The hydrophilic material as claimed in claim 5 which is a polymer comprised of recurring units of an alkylene glycol monoester of methacrylic acid in its polymeric chain.
Claim 9
Dependent Claim 19 words
The hydropholic material as claimed in claim 7 wherein said alkylene glycol monoester of methacrylic acid is 2-hydroxyethyl methacrylate.
Claim 10
Dependent Claim 27 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a monoakylene glycol monoester of methacrylic acid.
Claim 11
Dependent Claim 27 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a polyalkylene glycol monoester of methacrylic acid.
Claim 12
Dependent Claim 27 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a monoakylene glycol monoester of acrylic acid.
Claim 13
Dependent Claim 27 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a polyalkylene glycol monoester of acrylic acid.
Claim 14
Dependent Claim 24 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a N,N-dialkyl substituted methacrylamide.
Claim 15
Dependent Claim 24 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a N-alkyl substituted methacrylamide.
Claim 16
Dependent Claim 24 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a N,N-dialkyl substituted acrylamide.
Claim 17
Dependent Claim 24 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a N-alkyl substituted acrylamide.
Claim 18
Dependent Claim 21 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is N-vinylpyrrolidone.
Claim 19
Dependent Claim 24 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is an alkyl substituted N-vinylpyrrolidone.
Claim 20
Dependent Claim 25 words
The hydrophilic material as claimed in claim 1 wherein said polymer is comprised of at least the monomer which is a vicinal epoxy alkyl 2-alkenoate.
Claim 21
Dependent Claim 13 words
The material as claimed in claim 1 in the form of a chamber.
Claim 22
Dependent Claim 18 words
The chamber as claimed in claim 20 in the form of a pouch, sheet, laminate, capsule or membrane.
Claim 23
Dependent Claim 13 words
The chamber as claimed in claim 20 in the form of a pouch.
Claim 24
Dependent Claim 13 words
The chamber as claimed in claim 20 in the form of a sheet.
Claim 25
Dependent Claim 13 words
The chamber as claimed in claim 20 in the form of a laminate.
Claim 26
Dependent Claim 13 words
The chamber as claimed in claim 20 in the form of a capsule.
Claim 27
Dependent Claim 13 words
The chamber as claimed in claim 20 in the form of a membrane.
Claim 28
Dependent Claim 18 words
The device comprised of the chamber as claimed in claim 20 and particulate biologically active tissue contained therein.
Claim 29
Dependent Claim 16 words
The device as claimed in claim 27 wherein said biologically active tissue is viable pancreatic tissue.
Claim 30
Dependent Claim 51 words
The device as claimed in claim 27 in contact with body tissue and in osmotic equilibrium with body fluid thus permitting body nutrients from the body fluid to ingress into the device with the concomitant egress of biological active secretants produced from the biologically active tissue and nutrients to egress therefrom.
Claim 31
Dependent Claim 15 words
The device as claimed in claim 29 wherein said biologically active tissue is pancreatic tissue.
Claim 32
Dependent Claim 13 words
The material as claimed in claim 5 in the form of a chamber.
Claim 33
Dependent Claim 18 words
The chamber as claimed in claim 31 in the form of a pouch, membrane, laminate, sheet or capsule.
Claim 34
Dependent Claim 18 words
The device comprised of the chamber as claimed in claim 21 and particulate biologically active tissue contained therein.
Claim 35
Dependent Claim 51 words
The device as claimed in claim 33 in contact with body tissue and in osmotic equilibrium with body fluid thus permitting body nutrients from the body fluid to ingress into the device with the concomitant egress of biological active secretants produced from the biologically active tissue and nutrients to egress therefrom.
Claim 36
Dependent Claim 15 words
The device as claimed in claim 34 wherein said biologically active tissue is pancreatic tissue.
Claim 37
Dependent Claim 13 words
The material as claimed in claim 7 in the form of a chamber.
Claim 38
Dependent Claim 18 words
The device comprised of the chamber as claimed in claim 36 and particulate biologically active tissue contained therein.
Claim 39
Dependent Claim 13 words
The material as claimed in claim 8 in the form of a chamber.
Claim 40
Dependent Claim 17 words
The chamber as claimed in claim 30 in the form of a pouch, membrane, laminate, or capsule.
Claim 41
Dependent Claim 19 words
The device comprised of a membranous chamber as claimed in claim 31 and particulate biologically active tissue contained therein.
Claim 42
Dependent Claim 16 words
The device as claimed in claim 40 wherein said biologically active tissue is viable pancreatic tissue.
Claim 43
Dependent Claim 51 words
The device as claimed in claim 40 in contact with body tissue and in osmotic equilibrium with body fluid thus permitting body nutrients from the body fluid to ingress into the device with the concomitant egress of biological active secretants produced from the biologically active tissue and nutrients to egress therefrom.
Claim 44
Dependent Claim 15 words
The device as claimed in claim 42 wherein said biologically active tissue is pancreatic tissue.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1984-11-02 1985-05-04 1985-11-03 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1988-11-02 1989-05-04 1989-11-03 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1992-11-02 1993-05-04 1993-11-03 $7700.00 Window Closed / Lapsed

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