Embolic basket

Abstract

An intravascular basket device for use in capturing either naturally occurring or foreign debris found in blood vessels or other regions of the body. The basket device is fabricated from a tube and includes a mid-section having at least one ring configured in an alternating V-pattern. The basket device specifically embodies structure that provides enhanced radial opening and angular resistance to collapse.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of application Ser. No. 09 / 469,431, filed Dec. 23, 1999. The content of that application is hereby incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to intravascular devices and systems and more particularly, basket devices which can be used to capture embolic material or thrombi found in blood vessels. [0003] The intravascular basket device and system of the present invention is particularly useful when performing balloon angioplasty, stenting procedures, laser angioplasty or atherectomy in critical vessels where the release of embolic debris into the bloodstream can occlude the flow of oxygenated blood to the brain or other vital organs, which can cause devastating consequences to the patient. The basket device is also suited for the removal of clots adhering to vessel walls. The device is also suitable for removal of misplaced coils ...

AI Technical Summary

Benefits of technology

[0018] Briefly and in general terms, the present invention is directed towards a basket for removing undesired material or objects and restoring patency of blood vessels. The basket is a linked or monolithic framework of thin struts that is radially expansible. The basket of the present invention embodies a structure that provides a consistent radial opening as well as improved radial and angular resistance to collapse. That is, as the device is pulled such as through a vessel, the entrance thereto will not fall back or tip over. Moreover, the basket device maintains clearance in its interior space along its length allowing the material or objects to enter and be captured.

[0019] In one aspect of the invention, the basket includes struts with very small widths and thicknesses and rings with very small widths and thicknesses but large expansion ratios. It is particularly beneficial to manufacture the basket from a piece of tube stock, as opposed to prior art wire baskets, because the resulting basket is more ordered upon compression, returns to its expanded state more reliably and is quicker to manufacture. The body of the basket device is defined by a plurality of openings bounded by generally longitudinally and generally circumferentially extending members. A proximally extending member is attached to an elongate wire and the assembly is contemplated to be used in conjunction with a generally tubular delivery catheter. In this aspect the body provides enhanced stability at the proximal transition between the wire and the proximally extending members because the design may allow for varying lengths and widths of the proximally extending members. The basket may be manufactured from a single tubular element or from a sheet to form a desired configuration.

[0020] Overall, the intent of the invention is to provide a structure that has the capacity to engage, encompass and retain naturally occurring or foreign bodies while having a minimal profile that can traverse easily and repeatedly through a standard microcatheter across tortuous anatomy. The device embodies superior flexibility to be deployed and retrieved consistently across difficult anatomy while being able to retain captured material. The inner diameter of the device is heat-set to a pre-determined size. It is envisioned that there be a family of devices that have varying strut lengths, thicknesses, flexibility, and diameters as deemed appropriate for the specific type of vascular or non-vascular setting for which the device is to be used.

[0023] Moreover, the present invention embodies a tip for an endovascular device including an atraumatic soft coil for preventing damage to tissue and facilitates advanceability. The tip further includes multiple layers of coiled material to enhance these objectives as well as to provide stiffness variations.

Problems solved by technology

However, there is one common problem which can become associated with all of these types of procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient.

Additionally, while complete vaporization of plaque is the intended goal during a laser angioplasty procedure, quite often particles are not fully vaporized and thus enter the bloodstream.

When any of the above-described procedures are performed in the carotid arteries, cerebral vasculature, or neurovasculature, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient.

Naturally occurring debris can also be highly dangerous to a patient.

Debris that is carried by the bloodstream to distal vessels of the brain can cause these cerebral vessels to occlude, resulting in a stroke, and in some cases, death.

Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been limited due to the justifiable fear of causing an embolic stroke should embolic debris enter the bloodstream and block vital downstream blood passages.

However, it is often difficult to control the size of the fragments which are formed, and the potential risk of vessel occlusion still exists, making such a procedure in the carotid arteries a high-risk proposition.

In addition, the retrieval of fragmented clot may be incomplete, also resulting in emboli and distal occlusions, and further, access through tortuous lumens may prove difficult.

Local disruption may open up a proximal occlusion but also may cause significant distal emboli.

However, as mentioned above, there have been complications with such systems since the vacuum catheter may not always remove all of the embolic material from the bloodstream, and a powerful suction could otherwise cause problems to the patient's vasculature.

Other techniques which have had some limited success include the placement of a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream.

However, there have been problems associated with conventional filtering systems as well.

In particular, certain previously developed filtering devices do not optimize the area for embolic collection.

That is, conventional filtering devices may not present a collection device that spans the entirety of the vessel or it may include supporting structure that itself impedes emboli collection.

Certain other devices do not embody sufficient angular resistance to collapse.

However, in addition to suffering from the same disadvantages as certain conventional filter devices, such devices have been found to have structures which are either highly complex such as with multiple components or highly convoluted geometry or lacking in sufficient or effective expansion and retraction capabilities.

Disadvantages associated with the devices having highly complex structure such as with multiple components or highly convoluted geometry include difficulty in manufacturability as well as use in conjunction with microcatheters.

Other devices with less coverage can pull through clots due in part to the lack of experience in using the same or otherwise lack an expanded profile that is adequate to capture clots or foreign bodies.

Thrombo-embolic materials can be friable, amorphous, and / or lubricious in nature contributing to this difficulty.

These devices may have limited effectiveness, due in part to the lack of encapsulation.

Objects are difficult to grasp within these devices, and friable objects, e.g. blood-based blockages, tend to fragment when grasped or pulled, introducing multiple emboli.

These typically have the disadvantages of lengthy treatment / infusion times to remove the obstruction (>3 hrs.

Also, these drugs are not typically effective in removing obstructions that are not blood-based.

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