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Thrombus management device

a management device and thrombosis technology, applied in the field of thrombosis management devices, can solve the problems of slurred speech, paralysis, loss of memory or brain function, and even death, and achieve the effects of improving the quality of li

Inactive Publication Date: 2012-02-16
TYCO HEALTHCARE GRP LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method for treating acute ischemic stroke by restoring blood flow and addressing the clot that causes the damage. The method involves inserting a guide catheter and advancing a distal access catheter to the occluded vessel. An expandable tip assembly, comprising a scaffold, is then inserted through the microcatheter to impact and compress the clot. This can restore blood flow and facilitate natural lysis or fragmentation of the clot. The method can also involve macerating the clot by resheathing the scaffold and unsheathing it. The patent text also describes the need for progressive treatment based on the nature of the clot, and the use of a kit of devices for this purpose. Overall, the method aims to provide immediate treatment for acute ischemic stroke by restoring blood flow and addressing the clot that causes the damage.

Problems solved by technology

If not addressed quickly, the destruction of neurons and synapses of the brain after a stroke can result in slurred speech, paralysis, loss of memory or brain function, loss of motor skills, and even death.

Method used

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Examples

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example 1

Stress Test Evaluation for Vessel Tolerance of Revascularization System with Multiple Device Use

[0404]A study was performed to demonstrate that embodiments of multiple revascularization system devices (e.g., expandable tip assemblies) can be challenged and delivered to the target vessel, deployed and then withdrawn from the target vessel in serial fashion without inducing vessel trauma or injury. Angiographic assessment of the target vessels was performed after each device deployment and retrieval to assess performance and outcomes.

[0405]Testing was performed on swine animal models. The swine models were selected because the vascular anatomy and pathological response is comparable to that of the human. Specifically, the internal maxillary and renal arteries are of similar diameter to the human middle cerebral and basilar arteries with diameters of 2.5-3.0 mm respectively. Swine models have been used by neurovascular companies in support of U.S. FDA IDE studies and / or for 510 (k) cle...

example 2

Usability, Safety and Effectiveness of Expandable Tip Assemblies

[0418]A study was performed to determine the usability, safety and effectiveness of embodiments of neurothrombectomy devices comprising expandable tip assemblies designed and configured to facilitate clot removal. Testing was performed on swine animal models. The swine models were selected because the vascular anatomy and pathological response is comparable to that of the human. Swine models have been used by neurovascular companies in support of U.S. FDA IDE studies and / or for 510 (k) clearance. A total of two subject animals and six blood vessels were treated. The blood vessels treated were the left and right ascending pharyngeal, lingual and internal maxillary arteries.

[0419]Embodiments of the expandable tip assemblies or devices were introduced into the target vessels, deployed, pulled through the vessels and retracted into the guide catheter in a manner similar to that described above. This process was repeated up ...

example 3

Radial Force and Cell Characteristics Measurements

[0421]Testing was performed to compare radial force and cell characteristics of various vascular therapy devices, including embodiments of the expandable tip assemblies described herein. The vascular therapy devices tested and / or measured included a NeuroForm3™ device provided by Boston Scientific, an IRIIS™ Plus device provided by MindFrame, an IRIIS™ device provided by MindFrame, a Solitaire™ AB device provided by ev3, and an Enterprise™ device provided by Cordis. The IRIIS™ Plus and the IRIIS™ devices are embodiments of the expandable tip assemblies described herein.

[0422]The following tables illustrate the data collected from the testing. Graphical results of the data from Tables 1 and 2 can be found in FIGS. 6 and 7, respectively, of U.S. Patent Application Publication No. 2010 / 0174309, the entire contents of which has been incorporated by reference herein.

[0423]Table 1 below lists the data obtained from testing performed to det...

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Abstract

Systems, methods, and devices for the treatment of acute ischemic stroke that provide immediate blood flow restoration to a vessel occluded by a clot and, after reestablishing blood flow, address the clot itself. Immediate blood flow restoration advantageously can facilitate natural lysis of the clot and also can reduce or obviate the concern for distal embolization due to fragmentation of the clot. Several embodiments of the invention provide for progressive, or modular, treatment based upon the nature of the clot. For example, the progressive treatment can include immediate restoration of blood flow, in-situ clot management, and / or clot removal depending on the particular circumstances of the treatment. The in-situ clot management can include, for example, lysis, maceration, and / or removal.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part application of U.S. patent application Ser. No. 12 / 980,039, filed Dec. 28, 2010, which is a continuation-in part application of U.S. patent application Ser. No. 12 / 651,353 filed Dec. 31, 2009, which is a continuation-in part application of U.S. patent application Ser. No. 12 / 123,390 filed May 19, 2008, which claims priority to the following provisional applications: U.S. Provisional Application No. 60 / 980,736, filed Oct. 17, 2007; U.S. Provisional Application No. 60 / 987,384, filed Nov. 12, 2007; U.S. Provisional Application No. 60 / 989,422, filed Nov. 20, 2007; U.S. Provisional Application No. 61 / 015,154, filed Dec. 19, 2007; U.S. Provisional Application No. 61 / 019,506, filed Jan. 7, 2008; and U.S. Provisional Application No. 61 / 044,392, filed Apr. 11, 2008.[0002]This application is also a continuation-in-part application of U.S. patent application Ser. No. 12 / 123,390 filed May 19, 2008, which cla...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B17/22
CPCA61B17/221A61F2/82A61B2017/00867A61B2017/22001A61B2017/22039A61B2017/22079A61B2017/2212A61B2017/2215A61B2019/5466A61B17/12118A61B17/1214A61B17/320725A61F2/91A61F2/915A61M25/0074A61B2017/22034A61B2017/22094A61B2017/32096A61M2025/0042A61B2017/00309A61B2090/3966
Inventor FERRERA, DAVID A.CRAGG, ANDREW H.FULKERSON, JOHN
Owner TYCO HEALTHCARE GRP LP
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