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US6060640A Expired / Lapsed US ⏱️ 0.0 years remaining

Multiple-layer, formed-in-place immunoisolation membrane structures for implantation of cells in host tissue

Assignee: Baxter International Inc
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Filing: 1995-05-19
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Granted: 2000-05-09
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Expires: 2015-05-19
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Abstract

Abstract A permeable structure forms a chamber to hold living cells. The structure includes a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport. The structure also includes a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that permits solute transport. A third permeable region is located between the first and second permeable regions. The third region comprises a solution of polymer material formed in place between the first and second permeable regions. The third permeable region bonds the first and second permeable regions together. The third permeable region also has a conformation that, when implanted in host tissue, permits solute transport between the first and second permeable regions. The third, formed-in-place region bonds the first and second permeable regions together, providing a robust, laminated structure that resists delamination during implantation caused by cellular infiltration into discontinuous spaces between the first and second regions. The third, formed-in-place region can also have a conformation providing an immunoisolation effect. Furthermore, the permeability of the third, formed-in-place membrane is sufficient high that it does not adversely effect the permeability value desired for the overall multiple layer membrane structure.

Inventors

  • 👤 Robin G. Pauley
  • 👤 Donna L. McLarty
  • 👤 Atul R. Khare
  • 👤 Shmuel Sternberg
  • 👤 Daniel R. Boggs
  • 👤 Steven Neuenfeldt
  • 👤 Mark Jones
  • 👤 James H. Brauker
  • 👤 Laura A. Martinson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 04:58
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61F; A61F2/00; A61F2/02; A61F2/022; A61L; A61L27/00; A61L27/36; A61L27/38

Claims Analysis

Total Claims: 38
Claim 1
Independent Claim 145 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that permits solute transport between the host and cells, and a third permeable region between the first and second permeable regions comprising polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue, permits solute transport between the first and second permeable regions.
Claim 2
Dependent Claim 145 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that permits solute transport between the host and cells, and a third permeable region between the first and second permeable regions comprising polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue, permits solute transport between the first and second permeable regions.
Claim 3
Dependent Claim 157 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that promotes the growth of vascular structures near the permeable interface while permitting solute transport between the host and cells, and a third permeable region between the first and second permeable regions comprising a polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue permits solute transport between the first and second permeable regions.
Claim 4
Dependent Claim 157 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that promotes the growth of vascular structures near the permeable interface while permitting solute transport between the host and cells, and a third permeable region between the first and second permeable regions comprising a polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue permits solute transport between the first and second permeable regions.
Claim 5
Dependent Claim 185 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that permits solute transport between the host and cells, the first permeable region comprising an array of three dimensional strands having a first dimension larger than a second and third dimensions and, for the majority of strands, neither of the second and third dimensions exceeds about 5 μm, and a third permeable region between the first and second permeable regions comprising a polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue, permits solute transport between the first and second permeable regions.
Claim 6
Dependent Claim 185 words
A permeable structure forming a chamber to hold living cells, the permeable structure comprising a first permeable region surrounding at least a portion of the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of host cells into the chamber while permitting solute transport between the host and cells, a second permeable region overlying the first permeable region having a conformation that, when implanted in host tissue, forms a permeable interface with host tissue that permits solute transport between the host and cells, the first permeable region comprising an array of three dimensional strands having a first dimension larger than a second and third dimensions and, for the majority of strands, neither of the second and third dimensions exceeds about 5 μm, and a third permeable region between the first and second permeable regions comprising a polymer material layer formed in place between the first and second permeable regions, the third permeable region bonding the first and second permeable regions together and having a conformation that, when implanted in host tissue, permits solute transport between the first and second permeable regions.
Claim 7
Dependent Claim 37 words
A permeable structure according to claim 1 or 2 or 3 wherein the conformation of the first permeable region, when implanted in host tissue, substantially blocks penetration of at least host tissue inflammatory cells into the chamber.
Claim 8
Dependent Claim 33 words
A permeable structure according to claim 4 wherein the conformation of the third permeable region, when implanted in host tissue, substantially blocks penetration of at least host tissue inflammatory cells into the chamber.
Claim 9
Dependent Claim 43 words
A permeable structure according to claim 1 or 2 or 3 wherein the third permeable region is in substantially continuous, intimate contact with the first and second permeable regions to substantially block infiltration of host cells between the first and second permeable regions.
Claim 10
Dependent Claim 31 words
A permeable structure according to claim 1 or 2 or 3 wherein the third permeable region penetrates at least partially into at least one of the first and second permeable regions.
Claim 11
Dependent Claim 27 words
A permeable structure according to claim 1 or 2 or 3 wherein the third permeable region has a thickness of between about 0.1 μm and 20 μm.
Claim 12
Dependent Claim 35 words
A permeable structure according to claim 1 or 2 or 3 wherein the polymer material of the third permeable region is selected from a group consisting essentially of poly(ethylene-co-vinyl alcohol), cellulose acetate, and poly(vinylidene difluoride).
Claim 13
Dependent Claim 23 words
A permeable structure according to claim 1 or 2 or 3 wherein the polymer material of the third permeable region comprises poly(ethylene-co-vinyl alcohol).
Claim 14
Dependent Claim 27 words
A permeable structure according to claim 10 wherein the polymer material of the third permeable region comprises about 3% to about 8% by weight of poly(ethylene-co-vinyl alcohol).
Claim 15
Dependent Claim 44 words
A permeable structure according to claim 1 or 2 or 3 wherein the permeable structure has a determinable first permeability value, wherein the third region has a determinable second permeability value, and wherein the second permeability is at least twice the first permeability value.
Claim 16
Dependent Claim 19 words
A permeable structure according to claim 1 or 2 or 3 and further comprising living cells in the chamber.
Claim 17
Dependent Claim 18 words
A permeable structure according to claim 13 wherein the living cells are allogeneic with respect to host tissue.
Claim 18
Dependent Claim 18 words
A permeable structure according to claim 13 wherein the living cells are isogeneic with respect to host tissue.
Claim 19
Dependent Claim 36 words
A permeable structure according to claim 1 or 2 or 3 and further comprising instructions teaching enclosure of living cells within the chamber and implantation of the permeable structure with enclosed living cells in host tissue.
Claim 20
Dependent Claim 118 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable layer surrounding the chamber that, when implanted in host tissue, blocks contact between cells in the chamber and host cells while permitting transport of solutes between the host and cells, the permeable layer comprising a first immunoisolation region having a conformation that, when implanted in host tissue, substantially blocks penetration of host inflammatory cells, and a second immunoisolation region distinct from the first region, the second region having a conformation that, when implanted in host tissue, also substantially blocks penetration of host inflammatory cells, the first and second regions being mutually arranged in the permeable layer to together provide a redundant immunoisolation barrier.
Claim 21
Dependent Claim 118 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable layer surrounding the chamber that, when implanted in host tissue, blocks contact between cells in the chamber and host cells while permitting transport of solutes between the host and cells, the permeable layer comprising a first immunoisolation region having a conformation that, when implanted in host tissue, substantially blocks penetration of host inflammatory cells, and a second immunoisolation region distinct from the first region, the second region having a conformation that, when implanted in host tissue, also substantially blocks penetration of host inflammatory cells, the first and second regions being mutually arranged in the permeable layer to together provide a redundant immunoisolation barrier.
Claim 22
Dependent Claim 20 words
A permeable structure according to claim 17 wherein the first and second immunoisolation regions contact each other in the layer.
Claim 23
Dependent Claim 20 words
A permeable structure according to claim 17 wherein the first and second immunoisolation regions are spaced apart in the layer.
Claim 24
Dependent Claim 23 words
A permeable structure according to claim 17 wherein the first immunoisolation region is formed in place in contact with the second immunoisolation region.
Claim 25
Dependent Claim 32 words
A permeable structure according to claim 17 wherein the first immunoisolation region is cast in contact with the second immunoisolation region and coagulated in place in contact with the second immunoisolation region.
Claim 26
Dependent Claim 116 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable membrane surrounding the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells into the chamber while permitting solute transport between the host and cells, the permeable membrane having a surface, and an auxiliary permeable layer bonded in substantially continuous contact with the permeable membrane surface to substantially block infiltration of host cells between the auxiliary permeable layer and the permeable surface, the auxiliary permeable layer having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells while permitting solute transport through the permeable membrane.
Claim 27
Dependent Claim 116 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable membrane surrounding the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells into the chamber while permitting solute transport between the host and cells, the permeable membrane having a surface, and an auxiliary permeable layer bonded in substantially continuous contact with the permeable membrane surface to substantially block infiltration of host cells between the auxiliary permeable layer and the permeable surface, the auxiliary permeable layer having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells while permitting solute transport through the permeable membrane.
Claim 28
Dependent Claim 113 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable membrane surrounding the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells into the chamber while permitting solute transport between the host and cells, the permeable membrane having a surface, and an auxiliary permeable layer comprising a solution of polymer material brought into contact with the permeable membrane surface and formed in place on the permeable membrane surface, the auxiliary permeable layer having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells while permitting solute transport through the permeable membrane.
Claim 29
Dependent Claim 113 words
A permeable structure forming a chamber to hold living cells, the structure comprising a permeable membrane surrounding the chamber having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells into the chamber while permitting solute transport between the host and cells, the permeable membrane having a surface, and an auxiliary permeable layer comprising a solution of polymer material brought into contact with the permeable membrane surface and formed in place on the permeable membrane surface, the auxiliary permeable layer having a conformation that, when implanted in host tissue, substantially blocks penetration of at least host inflammatory cells while permitting solute transport through the permeable membrane.
Claim 30
Dependent Claim 40 words
A permeable structure according to claim 23 wherein the auxiliary permeable layer is in substantially continuous, intimate contact with the permeable membrane surface to substantially block infiltration of host cells between the auxiliary permeable layer and the permeable membrane surface.
Claim 31
Dependent Claim 23 words
A permeable structure according to claim 22 or 23 wherein the auxiliary permeable layer penetrates at least partially into the permeable membrane surface.
Claim 32
Dependent Claim 33 words
A permeable structure according to claim 22 or 23 wherein the polymer material of the auxiliary permeable layer is selected from a group consisting essentially of poly(ethylene-co-vinyl alcohol), cellulose acetate, and poly(vinylidene difluoride).
Claim 33
Dependent Claim 21 words
A permeable structure according to claim 22 or 23 wherein the polymer material of the auxiliary permeable layer comprises poly(ethylene-co-vinyl alcohol).
Claim 34
Dependent Claim 27 words
A permeable structure according to claim 27 wherein the polymer material of the auxiliary permeable layer comprises about 3% to about 8% by weight of poly(ethylene-co-vinyl alcohol).
Claim 35
Dependent Claim 17 words
A permeable structure according to claim 22 or 23 and further comprising living cells in the chamber.
Claim 36
Dependent Claim 18 words
A permeable structure according to claim 29 wherein the living cells are allogeneic with respect to host tissue.
Claim 37
Dependent Claim 18 words
A permeable structure according to claim 29 wherein the living cells are isogeneic with respect to host tissue.
Claim 38
Dependent Claim 34 words
A permeable structure according to claim 22 or 23 and further comprising instructions teaching enclosure of living cells within the chamber and implantation of the permeable structure with enclosed living cells in host tissue.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-05-09 2003-11-08 2004-05-09 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2007-05-09 2007-11-08 2008-05-09 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2011-05-09 2011-11-08 2012-05-09 $7700.00 Window Closed / Lapsed

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