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US-12623005-B2 - Textile products having selectively applied sealant or coating

US12623005B2US 12623005 B2US12623005 B2US 12623005B2US-12623005-B2

Abstract

An implantable tubular textile graft includes a water-insoluble elastomeric sealant disposed at the textile tubular wall such that the graft is impermeable to water at 120 mm Hg pressure. The inner surface of the textile tubular wall configured to promote growth of biological tissue and/or promote growth of pseudointima.

Inventors

  • David Granville Stevenson
  • Timothy Rawden Ashton

Assignees

  • Hothouse Medical Limited

Dates

Publication Date
20260512
Application Date
20221019
Priority Date
20171031

Claims (17)

  1. 1 . An implantable textile graft comprising: a conduit, comprising a liquid permeable textile tubular wall comprising an inner surface, an intermediate portion, and an outer surface, said textile tubular wall comprising one or more yarns; said conduit comprises a cured layer disposed between about 4 mg/cm 2 and 19 mg/cm 2 of area of the textile tubular wall and comprising a substantially water-insoluble, non-biodegradable elastomeric sealant selected from the group consisting of a silicone-containing polymer, a polyurethane-containing polymer, a polycarbonate-containing polymer, and combinations thereof, disposed on said outer surface and said intermediate portion; wherein (i) said cured layer on said outer surface does not exhibit signs of delamination when said conduit is pressurized with water at 120 mmHg; and (ii) after curing of the substantially water-insoluble elastomeric sealant, said conduit has a water permeability of about 0.16 ml/min/cm 2 at 120 mmHg pressure or less than 0.16 ml/min/cm 2 at 120 mmHg pressure.
  2. 2 . The graft of claim 1 , wherein said cured layer on said outer surface does not exhibit signs of delamination when said conduit is pressurized with water for 1 minute at about 600 mmHg.
  3. 3 . The graft of claim 1 , wherein said cured layer on said outer surface does not exhibit signs of delamination when said conduit is pressurized with water for 1 minute in a pressure range of from 120 mmHg to 600 mmHg.
  4. 4 . The graft of claim 1 , wherein, after curing of the substantially water-insoluble elastomeric sealant, the textile tubular wall is configured to obviate the leaking of blood therefrom at a blood pressure of up to about 200 mmHg.
  5. 5 . The graft of claim 1 , wherein, after curing of the substantially water-insoluble elastomeric sealant, the textile tubular wall is configured to obviate the leaking of blood therefrom at a blood pressure of up to about 300 mmHg.
  6. 6 . The graft of claim 1 , wherein the textile construction is selected from the group consisting of a weave of the one or more multi-filament yarns, a knit of the one or more multifilament yarns, a braid of the one or more multi-filament yarns, a web of the one or more multi-filament yarns, and a felt of the one or more multi-filament yarns.
  7. 7 . The graft of claim 1 , wherein the textile tubular wall is a crimped wall having a plurality of peaks and valleys; and wherein the substantially water-insoluble sealant is disposed at about 8 mg/cm 2 of area of the textile tubular wall or greater than 8 mg/cm 2 of area of the textile tubular wall.
  8. 8 . The graft of claim 1 , wherein the textile tubular wall is a non-crimped wall being substantially free of peaks and valleys; and wherein the substantially water-insoluble elastomeric sealant is disposed at about 4 mg/cm 2 of area of the textile tubular wall or greater than 4 mg/cm 2 of area of the textile tubular wall.
  9. 9 . The graft of claim 1 , wherein the inner surface is at least 70% free of the substantially water-insoluble elastomeric sealant.
  10. 10 . The graft of claim 1 , wherein the inner surface is at least 95% free of the substantially water-insoluble elastomeric sealant.
  11. 11 . The graft of claim 1 , wherein one portion of the tubular wall has a first level of the substantially water-insoluble elastomeric sealant to provide a first soft, flexible zone; wherein another portion of the tubular wall has a second level of the substantially water insoluble elastomeric sealant to provide a second zone having a stiffness greater than the first zone; and wherein the second level of the substantially water-insoluble elastomeric sealant is greater than the first level of the substantially water-insoluble sealant.
  12. 12 . The graft of claim 1 , wherein the tubular wall has a plurality of portions having different levels of the substantially water-insoluble elastomeric sealants to provide a plurality of portions having different levels of stiffnesses.
  13. 13 . The graft of claim 1 , wherein the water-insoluble elastomeric sealant is penetrating no more than about 50% into a fabric thickness of the tubular wall.
  14. 14 . The graft of claim 1 , wherein the water-insoluble elastomeric sealant is penetrating up to at least about 50% into a fabric thickness of the tubular wall.
  15. 15 . The graft of claim 1 , wherein inner surface is configured to promote biological tissue growth thereon.
  16. 16 . An implantable textile graft comprising: a conduit, comprising a liquid permeable textile tubular wall comprising an inner surface, an intermediate portion, and an outer surface, said textile tubular wall comprising one or more yarns; said conduit comprises a cured layer disposed between about 4 mg/cm 2 and 19 mg/cm 2 of area of the textile tubular wall and comprising a substantially water-insoluble, non-biodegradable elastomeric sealant selected from the group consisting of a silicone-containing polymer, a polyurethane-containing polymer, a polycarbonate-containing polymer, and combinations thereof, disposed on said outer surface and said intermediate portion; wherein (i) the water-insoluble elastomeric sealant is penetrating at about 50% or less than 50% into a fabric thickness of the tubular wall; and (ii) after curing of the substantially water-insoluble elastomeric sealant, said conduit has a water permeability of about 0.16 ml/min/cm 2 at 120 mmHg pressure or less than 0.16 ml/min/cm 2 at 120 mmHg pressure.
  17. 17 . An implantable textile graft comprising: a conduit, comprising a liquid permeable textile tubular wall comprising an inner surface, an intermediate portion, and an outer surface, said textile tubular wall comprising one or more yarns; said conduit comprises a cured layer disposed between about 4 mg/cm 2 and 19 mg/cm 2 of area of the textile tubular wall and consisting essentially of a substantially water-insoluble, non-biodegradable elastomeric silicone sealant disposed on said outer surface and said intermediate portion; wherein (i) said cured layer on said outer surface does not exhibit signs of delamination when said conduit is pressurized with water at 120 mmHg; and (ii) after curing of the substantially water-insoluble elastomeric silicone sealant, said conduit has a water permeability of about 0.16 ml/min/cm 2 at 120 mmHg pressure or less than 0.16 ml/min/cm 2 at 120 mmHg pressure.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a Continuation of U.S. patent application Ser. No. 17/308,383, filed May 5, 2021, which is a Continuation of U.S. patent application Ser. No. 16/407,041, filed May 8, 2019, now U.S. Pat. No. 11,027,046, issued Jun. 8, 2021, which is a Continuation-In-Part of U.S. patent application Ser. No. 16/273,320, filed Feb. 12, 2019, now U.S. Pat. No. 10,926,003, issued Feb. 23, 2021, which is a Continuation of International Application No. PCT/GB2018/053161, filed Oct. 31, 2018, which designated the United States of America, and which embodiments claim the benefit of Great Britain Application No. GB 1717885.6, filed Oct. 31, 2017, the contents of all of which are incorporated by reference herein. FIELD OF THE INVENTION This invention relates to textile products, such as a vascular or endovascular prostheses having a selectively applied sealing layer or coating and particularly but not exclusively, a method of manufacturing the textile products, such as prostheses, a kit of parts for manufacturing the textile products, such as prostheses, a vascular system including the prosthesis, a method of implanting the prosthesis and a method of implanting the vascular system. BACKGROUND TO THE INVENTION Vascular prostheses, or grafts, are used extensively in surgical procedures, such as in treating abdominal and thoracic vascular disease. Vascular grafts are typically required to be sealed prior to implantation, in order to prevent blood from leaking from the vascular graft after implant. Known techniques for sealing vascular grafts include the use of biodegradable (or bioresorbable or bioabsorbable) animal-derived materials such as bovine gelatine, bovine albumin or bovine collagen to seal the graft. Other techniques for sealing vascular grafts use synthetic materials, some of which are not able to biodegrade when implanted in a human or animal body. It is desirable for the sealed graft, once implanted in a human or an animal body, to allow the ingrowth of tissue on the inner surface of the vascular graft and to ensure that the ingrowing tissue adheres to the inner surface of the vascular graft. However, conventional techniques for sealing vascular grafts often suffer from the ingress of the sealant into the inner surface of the vascular graft. The presence of sealing material has an adverse effect on the growth of tissue on the inner surface of the graft. Furthermore, the presence of sealing material on the inner surface of the graft also contributes to poor adhesion between the ingrowing tissue and the vascular graft, which can lead to reduced vascular performance of the vascular graft. It is therefore desirable to provide a vascular graft which does not hinder the ingrowth of tissue and which allows the ingrowing tissue layer to adhere to the inner surface. In an attempt to better enable growth and adhesion of tissue on the inner surface of the graft, biodegradable animal-derived materials such as those noted above can be used to seal the graft. When such a graft is implanted, it is desirable for the sealant material to degrade once the ingrowing tissue layer is sufficiently mature. However, conventional methods of sealing vascular grafts do not exhibit consistent and predictable degradation times. This has considerable implications on the performance of some vascular grafts. For example, if the sealant material degrades before the ingrowing tissue layer has developed into a pseudointima (an example of a tissue layer on the inner surface of a vascular graft), blood will leak from the vascular graft. If the sealant material degrades too slowly, the ingrowing tissue will suffer from poor adhesion to the inner surface of the graft (because the inner surface of the graft is still coated in sealing material), and is likely to delaminate from the vascular graft. Haemorrhagic dissection could then occur in the pseudointima. There is therefore a need to provide a method of sealing vascular grafts that enables predictable growth and adhesion of tissue to the inner surface of the vascular graft. A further issue with existing vascular grafts is that some animal-derived sealants of the type typically used are thought to increase the risk of bovine spongiform encephalopathy (BSE) transmission. This risk is usually mitigated by extensive supply chain regulation requirements, which are onerous and burdensome. It is desirable to provide a vascular graft which has less burdensome regulatory requirements, such that new materials and designs can be brought to use in a shorter time and in a more cost-effective way. Furthermore, animal-derived sealants are incompatible with an array of processing techniques, which limits the options available to vascular graft designers. Vascular grafts sealed using animal-derived sealants are also typically required to be transported, or packaged, with control over the temperature and humidity to obviate deterioration of the sealant material. Therefor