Materials and methods for treating and managing plaque disease

A vascular access and blood flow technology, applied in the field of enhancing vascular access and compositions, can solve problems such as prolonging functional dialysis access leaks, and achieve the effects of enhancing maturity and maintaining functional lifespan

Inactive Publication Date: 2008-03-12
SHIRE REGENERATIVE MEDICINE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Indeed, at present, no effective surgical, therapeutic, or pharmacological approach to prolonging the survival of functional dialysis access leaks is available to clinicians, regardless of the enormity of the problem

Method used

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  • Materials and methods for treating and managing plaque disease
  • Materials and methods for treating and managing plaque disease
  • Materials and methods for treating and managing plaque disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0179] Example 1: Human AV Fistula Study

[0180] This example provides a protocol for testing and using preferred embodiments of implantable materials including vascular endothelial cells to enhance fistula maturation and / or prevent fistula maturation failure. Using standard surgical procedures, create an arteriovenous fistula at the desired anatomical location. The implantable material in flexible planar form is then deposited in the perivascular space adjacent to the surgically created fistula; details of one exemplary procedure are set forth below. As previously mentioned, the placement and configuration of the implantable material can be varied to suit the clinical situation. In this study, preferred exemplary flexible planar forms are shown at least in Figure 1 or 2A.

[0181] The following experiments and protocols provide sufficient guidance:

[0182] 1. Assess the failure of the arteriovenous fistula to mature at 3 months.

[0183] For this study, mature failure...

Embodiment 2

[0200] Example 2: AV Graft Animal Studies

[0201] This example provides a protocol for testing and using preferred embodiments of the invention to promote the formation of functional AV grafts in animal test subjects. Using standard surgical procedures, create an AV graft between the carotid artery and the jugular vein. The implantable material was then placed in the perivascular space adjacent to the anastomosis of each surgically created AV graft; details of an exemplary procedure are set forth below. As previously mentioned, the placement and configuration of the implantable material can vary. In this study, the implantable material in the form of a flexible planar surface is shown in Figures 4A, 4B and 4C.

[0202] Specifically, this study included 26 pig subjects who underwent AV transplantation. Conventional AV transplantation is performed according to standard operating techniques. Following completion of the graft procedure and establishment of blood flow throug...

Embodiment 3

[0226] Example 3: Clinical Study of Human AV Grafts

[0227] This example provides a protocol for testing and using the invention in human clinical subjects to promote the formation of functional AV grafts. Using standard surgical procedures, the AV graft anastomosis was fabricated at the desired anatomical location and an ePTFE prosthetic bridge was placed between the arterial and venous anastomosis. The implantable material was then deposited in the perivascular space adjacent to the anastomosis of each surgically created AV graft; details of an exemplary procedure are set forth below. As previously mentioned, the placement and configuration of implantable materials can be varied in a routine manner by the skilled practitioner.

[0228] Specifically, the study included human subjects who underwent AV transplantation. Traditional AV transplantation procedures are performed according to standard operating techniques. Following completion of the graft procedure and establi...

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Abstract

Disclosed herein are materials and methods suitable for treating and managing plaque disease, including vulnerable plaque. An implantable material comprising cells, such as but not limited to endothelial cells, and a biocompatible matrix can reduce progression or deterioration of a plaque-associated lesion situated on the interior lumen of said blood vessel. The implantable material is implanted directly on an exterior surface of a blood vessel at or adjacent or in the vicinity of the site of a lesion on an interior lumen. Alternatively, the implantable material is deposited on an exterior surface at or adjacent or in the vicinity of the site of a lesion on an interior lumen by an intraluminal delivery device which traverses or penetrates the vessel wall or by a percutaneous delivery device which enters the perivascular space. Both modes of administration can be preceded by or coincident with an imaging step. The present invention can treat hemorrhage, erosion, fissure, plaque-associated thrombosis and occlusion, rupture, displacement and / or dislodgement of a plaque lesion.

Description

[0001] Related application materials [0002] This non-provisional patent application filed December 6, 2005 as required by 35 U.S.C. Section 119(e) Provisional patent application U.S.S.N. 60 / 634,155 filed December 8, 2004, March 21, 2005 Provisional Patent Application U.S.S.N. 60 / 663,859 filed on May 19, 2005, U.S.S.N. 60 / _____,_____, filed on May 19, 2005, and U.S.S.N. 60 / _____,_____, filed on _____________; 35 Sections 120, 363 and / or 365 require co-pending International Patent Application PCT / US___ (also known as Attorney Docket No. ELV-008PC) filed on the same date as this application, and co-pending Priority of International Patent Application PCT / US_______ (also referred to as Attorney Docket No. ELV-009PC); the entire contents of each of the above patent applications are incorporated herein by reference. Background of the invention [0003] Vascular access failure is a major complication in providing hemodialysis care to patients with end-stage renal disease (ESRD). ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/38A61F2/06A61L29/16
Inventor 海伦·玛丽·纽金特埃拉扎尔·埃德尔曼阿努帕姆·达拉尔史蒂夫·博林杰斯科特·埃珀利
Owner SHIRE REGENERATIVE MEDICINE INC
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