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Systems, methods and devices for ablation, crossing, and cutting of occlusions




Title: Systems, methods and devices for ablation, crossing, and cutting of occlusions.
Abstract: Ablation, crossing, and cutting systems, devices and associated methods, including a crossing device, comprising, in combination: a spring-enhanced handle and body configured to controllably extend and retract a blade within a microcatheter for addressing an occlusion within a vessel of a patient to provide improved access for supplemental treatment and reperfusion. ...


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USPTO Applicaton #: #20130035750
Inventors: Isa Rizk, John Fulkerson


The Patent Description & Claims data below is from USPTO Patent Application 20130035750, Systems, methods and devices for ablation, crossing, and cutting of occlusions.

RELATED APPLICATION

This application claims the full Paris Convention benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/239,321, filed Sep. 2, 2009; and PCT Application Serial No. PCT/US09/55950, filed on Sep. 3, 2009; the contents of which are incorporated by reference herein in their entirety, as if fully set forth herein.

BACKGROUND

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Field

This disclosure relates to systems and apparatus for treating humans via allopathic or surgical intervention, minimally invasive surgical practices, endovascular procedures, percutaneous procedures, and related medical procedures. Specifically, this disclosure relates to systems for addressing vessel lumen-based issues and treatment of occlusions within a body, including those related to peripheral vascular disease states, cardiovascular diseases, cerebrovascular diseases, and others.

SUMMARY

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Improved ablation, crossing, and cutting devices and associated systems and methods are disclosed for treatment of occlusions within a body, owing to the paucity of effective devices available clinically, and the longstanding needs in this field of art.

According to embodiments, a crossing device is disclosed, comprising, in combination: a body coupled to a microcatheter at a proximal end of the microcatheter; a handle coupled to a blade at a proximal end of the blade, the blade disposed within a lumen of the microcatheter; wherein a sharpened tip of the blade is configured to advance from a natural position within the lumen of the microcatheter to an extended position beyond a distal end of the microcatheter as the handle is advanced relative to the body.

The crossing device may further comprise a spring configured to compress as the handle is advanced relative to the body; wherein the spring is configured to expand and retract the blade relative to the microcatheter as the handle is released.

The crossing device may further comprise a luer configured to attach to a proximal end of the handle and provide adaptable use of a supplemental treatment device in combination with the crossing device. The luer may be configured to guide a supplemental treatment device to the lumen of the microcatheter or a lumen of the blade. The supplemental treatment device may be at least one of: a guidewire, a PTA balloon, and a stent device.

The tip of the blade may be disposed at a distal end of the blade and is of a rigid material. The tip of the blade may be a hollow, sharpened, everted tip.

The handle and the body may be configured to limit the expansion of the spring and provide the natural position of the blade and further configured to selectively lock the blade in at least one of the natural position and the extended position. The body may further comprise a nose detachable from the body and secured to the microcatheter, such that the microcatheter is selectively removable from the body.

According to embodiments, an improved surgical method for addressing blockage within a vessel is disclosed, comprising, in combination: delivering an apparatus including at least a microcatheter to a desired treatment situs; positioning the microcatheter having at least a blade proximate to a surface of an occlusion, wherein the microcatheter is attached to a body and comprises a lumen; providing the blade within the lumen of the microcatheter to the surface of the occlusion, wherein the blade is attached to a handle; advancing the blade to an extended position by manipulation of the handle relative to the body; and retracting the blade to a natural position by releasing the handle.

The blade may be retracted by a spring between the handle and the body. The method may result in reconfiguration of at least a portion of the occlusion, whereby a different flow condition may be achieved.

The method may further comprise advancing the microcatheter and the blade through a channel created by advancement of the blade to an extended position. The method may further comprise providing a supplemental treatment device to the occlusion through a lumen of the blade. The supplemental treatment device may be at least one of a guidewire, a PTA balloon, and a stent device.

According to embodiments, a kit is disclosed, comprising: a crossing device further comprising: a body coupled to a microcatheter at a proximal end of the microcatheter; a handle coupled to a blade at a proximal end of the blade, the blade disposed within a lumen of the microcatheter; wherein a sharpened tip of the blade may be configured to advance from a natural position within the lumen of the microcatheter to an extended position beyond a distal end of the microcatheter as the handle is advanced relative to the body; and directions for use.

The kit may further comprise a supplemental treatment device configured to be advanced within the lumen of the microcatheter. The kit may further comprise a luer disposed at a proximal end of the handle and configured to guide the supplemental treatment device into the lumen of the microcatheter. The supplemental treatment device may be at least one of: a guidewire, a PTA balloon, and a stent device.

A system for addressing obstructions within lumens, comprising, in combination: a body coupled to a microcatheter at a proximal end of the microcatheter; a handle coupled to a blade at a proximal end of the blade, the blade disposed within a lumen of the microcatheter; a luer configured to attach to a proximal end of the handle and provide adaptable use of a supplemental treatment device in combination with the crossing device; a spring configured to compress as the handle is advanced relative to the body; wherein a tip of the blade may be configured to advance from a natural position within the lumen of the microcatheter to an extended position beyond a distal end of the microcatheter as the handle is advanced relative to the body; wherein the spring may be configured to expand and retract the blade relative to the microcatheter as the handle is released.

DRAWINGS

The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which:

FIG. 1A is a schematic view of an embodiment of a crossing device in a natural position, according to embodiments of the present disclosure;

FIG. 1B is a schematic view of an embodiment of a crossing device in an extended position, according to embodiments of the present disclosure;

FIG. 2A is a schematic view of an embodiment of a crossing device in a natural position, according to embodiments of the present disclosure;

FIG. 2B is a schematic view of an embodiment of a crossing device in an extended position, according to embodiments of the present disclosure;

FIG. 3 is an exploded view of an embodiment of a crossing device, according to embodiments of the present disclosure;

FIG. 4 is a cross-sectional view of an embodiment of a crossing device, according to embodiments of the present disclosure;

FIG. 5A is a schematic view of an embodiment of a blade of a crossing device, according to embodiments of the present disclosure; and

FIG. 5B is a schematic view of an embodiment of a blade of a crossing device, according to embodiments of the present disclosure.

The present inventors have discovered that treatment of conditions, including chronic total occlusions, remain challenged by the paucity of extent devices. Namely, surgeons require improved apparatus to impact, address, and ameliorate occlusions by thrombi, emboli, and other obstructions in real time during procedures.

In the following detailed description of embodiments of the present disclosure, reference is made to the accompanying drawings in which like references indicate similar elements, and in which is shown by way of illustration specific embodiments in which the present disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present disclosure, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical, functional, and other changes may be made without departing from the scope of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present disclosure is defined only by the appended claims. As used in the present disclosure, the term “or” shall be understood to be defined as a logical disjunction and shall not indicate an exclusive disjunction unless expressly indicated as such or notated as “xor.”




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stats Patent Info
Application #
US 20130035750 A1
Publish Date
02/07/2013
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
0


Addressing Catheter Fusion Occlusion Perfusion Reperfusion

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20130207|20130035750|systems, methods and devices for ablation, crossing, and cutting of occlusions|Ablation, crossing, and cutting systems, devices and associated methods, including a crossing device, comprising, in combination: a spring-enhanced handle and body configured to controllably extend and retract a blade within a microcatheter for addressing an occlusion within a vessel of a patient to provide improved access for supplemental treatment and |Reflow-Medical-Inc
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