Ultrasoft embolism devices and process for using them

Details Ultrasoft embolism devices and process for using them Ultrasoft embolism devices and process for using them

1995-05-15

1998-02-17

Dawson, Glenn K.

Surgery

Instruments

Internal pressure applicator

128898, A61B 1700

Patent

active

057187118

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/US93/09914, filed on Oct. 15, 1993.


FIELD OF THE INVENTION

This invention is an exceptionally flexible, ultrasoft vaso-occlusive or embolism forming device. It is made of a radiopaque material which may be a braid, coil, or chain which forms a long, thin threadlike device having little rigidity or column strength. The diameter of the device may be less than about 0.010 inches. The filamentary material making up the device used to form the coil, braid, or chain is typically of a diameter less than about 0.002 inches. The device is sufficiently flexible and small that it may be hydraulically delivered to a site within the vasculature of the human body using an injected drug or fluid flush through a catheter. In some configurations, the device may be delivered using pushers to mechanically deliver the device through the catheter lumen. Various mechanical connections may be used to sever the coil but a simple connection of a dissimilar metal to allow electrolytic separation upon application of a small voltage is desirable. The device assumes a random mass of threadlike material after being ejected from the catheter tip at the chosen vascular site. When the device is a coil, the coil may be a single or of multiple helices. The device (whether coil or braid or chain) may be used alone or in conjunction with larger coils or braids to achieve a denser occlusion or with fibrous thrombotic attachments or as a substrate to localize the subsequent infusion of tissue adhesives, particulate embolization devices, or chemotherapeutic agents in abnormal blood vessels and tissues. The device may be used for the temporary occlusion of blood vessels during types of diminished blood flow testing. The invention also includes processes for introducing the devices into the human body.


BACKGROUND OF THE INVENTION

Endovascular therapy has been used in treating a variety of different conditions, including control of internal bleeding, occlusion of blood supply to tumors, and relief of vessel wall pressure in the region of aneurysm. A variety of different embolic agents are known as arguably suitable for such therapy.
One known embolic agent includes injectable fluids or suspensions, such as microfibrillar collagen, various polymeric beads, and polyvinyl alcohol foam. The polymeric agents may be additionally crosslinked, sometimes in vivo, to extend the persistence of the agent at the desired vascular site. These agents are often introduced into the vasculature through a catheter. After such introduction, materials there form a solid space-filling mass. Although they provide good short-term vaso-occlusion, they are ultimately reabsorbed in the process of vessel recanalization.
Polymer resins, typically cyanoacrylates, are also employed as injectable vaso-occlusive materials. The resins are typically mixed with a radio-opaque contrast material or made radiopaque by the addition of tantalum powder. Their use is fraught with problems in that placement of the mixture is quite difficult. Inadvertent embolisms in normal vasculature (due to the inability of controlling the destination of the pre-gelled resins) is not altogether uncommon. The material is also difficult or impossible to retrieve once it has been placed in the vasculature. Such resins have not been FDA approved, and a waiver must be requested in each instance where the materials are applied during human operative procedures.
A number of mechanical vaso-occlusive devices are widely used. One such device is a balloon which may be carried to the vessel site at the end of the catheter and there inflated with a suitable fluid, typically a polymerizable resin, and released from the end of the catheter. The balloon device has the advantage that it effectively fills the cross-section of the occluded vessel. However, when using intravascular balloon embolization of intracranial berry aneurysms, inflation of a balloon into the aneurysm carries some risk of aneurysm rupture due to possible "overfilling" of portions of the sac and due to the traction

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