Steering, piercing, anchoring, distending extravascular guidewire
First Claim
1. A guidewire assembly providing the means of being introduced into the vasculature of the body percutaneously, steered by an operator located outside the body, moving intravascularly without injury to the vascular walls and, moving extravascularly, by piercing vascular walls and tissue surrounding said vasculature, thus creating extravascular pathways, and further enabling retrieval of said guidewire assembly should it break in the body, comprising,a. a flexible tube of metal, carbon fiber or other material in a coil or with cut slots having a proximal end and a distal end with lumen therebetween and with a section near said distal end being biased to assume a curved shape that returns to the original radius of curvature after being deviated and said lumen can carry contrast fluid,b. a stylet wire made of stainless steel, NITINOL or other alloy, disposed in said lumen, and having a distal end with a sharp point, proximal end extending beyond said proximal end of said flexible tube, and with said distal end being extensible into said curved shape and beyond said distal end of said flexible tube to pierce tissue or other substances,c. a ribbon wire disposed in said lumen of said flexible tube with a distal end attached to said distal end of said flexible tube on the side of said flexible tube farthest from the center of curvature of said curved shape, and continuing proximally beyond said proximal end of said flexible tube so as to be accessible to said operator to pull to increase the radius of curvature of said curved shape or relax to allow the said curved shape to return toward the un-deviated radius, and provide for retrieving said guidewire assembly should it break in the body,d. a hollow tip of metal or polymer with a proximal end and distal end and lumen therebetween, said proximal end being attached to said distal end of said flexible tube by such means as welding or brazing, said lumen being a slidably larger exit tunnel for said stylet wire and including a cross sectional shape like that of said stylet wire where it fits through said exit tunnel,whereby said guidewire assembly can be steered by said operator in the direction said distal end of said flexible tube is pointed by means of (a) advancing said stylet wire in said curved shape thus tending to increase said radius of curvature, and withdrawing said stylet wire in the proximal direction thus allowing the distal end section to return to the biased curvature, (b) pulling said ribbon wire thus tending to increase said radius of curvature toward straight, and (c) rotating said stylet wire in said hollow tip, with both of similar cross section, efficiently delivers rotational torque from proximal end of said guidewire assembly to said distal end of said guidewire, thus rotating the plane of curvature of said curved section in the direction said operator wishes to steer said guidewire assembly, and further stiffening said curved section by advancing said stylet wire in said curved section and by keeping said stylet wire from twisting outside the plane of curvature thereby causing more of the force applied on said proximal end to be delivered in the desired forward direction, thus piercing said tissue more easily to create said extravascular pathway where percutaneously introduced grafts may subsequently be placed without surgery, and said ribbon wire providing a means of retrieving said guidewire assembly should said flexible tube break in said body.
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Accused Products
Abstract
A steerable guidewire assembly for intravascular and extravascular movement includes a flexible tube with a distal and proximal end and a lumen therebetween with the distal end being biased to assume a curved shape, a stylet wire disposed in the lumen that can be advanced beyond the distal end of the flexible tube to create an extravascular pathway by piercing tissue, a wire with a shape memory of a knot to replace the stylet wire and anchor the guidewire and/or the wire on the pathway, multiple flexible tubes of increasing diameter that distend the extravascular pathway when advanced over each other, radiopaque and radiodense materials to create distinguishable dark and bright images on fluoro-unit screens, and mechanisms for conveniently controlling movement from outside the body are disclosed.
69 Citations
20 Claims
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1. A guidewire assembly providing the means of being introduced into the vasculature of the body percutaneously, steered by an operator located outside the body, moving intravascularly without injury to the vascular walls and, moving extravascularly, by piercing vascular walls and tissue surrounding said vasculature, thus creating extravascular pathways, and further enabling retrieval of said guidewire assembly should it break in the body, comprising,
a. a flexible tube of metal, carbon fiber or other material in a coil or with cut slots having a proximal end and a distal end with lumen therebetween and with a section near said distal end being biased to assume a curved shape that returns to the original radius of curvature after being deviated and said lumen can carry contrast fluid, b. a stylet wire made of stainless steel, NITINOL or other alloy, disposed in said lumen, and having a distal end with a sharp point, proximal end extending beyond said proximal end of said flexible tube, and with said distal end being extensible into said curved shape and beyond said distal end of said flexible tube to pierce tissue or other substances, c. a ribbon wire disposed in said lumen of said flexible tube with a distal end attached to said distal end of said flexible tube on the side of said flexible tube farthest from the center of curvature of said curved shape, and continuing proximally beyond said proximal end of said flexible tube so as to be accessible to said operator to pull to increase the radius of curvature of said curved shape or relax to allow the said curved shape to return toward the un-deviated radius, and provide for retrieving said guidewire assembly should it break in the body, d. a hollow tip of metal or polymer with a proximal end and distal end and lumen therebetween, said proximal end being attached to said distal end of said flexible tube by such means as welding or brazing, said lumen being a slidably larger exit tunnel for said stylet wire and including a cross sectional shape like that of said stylet wire where it fits through said exit tunnel, whereby said guidewire assembly can be steered by said operator in the direction said distal end of said flexible tube is pointed by means of (a) advancing said stylet wire in said curved shape thus tending to increase said radius of curvature, and withdrawing said stylet wire in the proximal direction thus allowing the distal end section to return to the biased curvature, (b) pulling said ribbon wire thus tending to increase said radius of curvature toward straight, and (c) rotating said stylet wire in said hollow tip, with both of similar cross section, efficiently delivers rotational torque from proximal end of said guidewire assembly to said distal end of said guidewire, thus rotating the plane of curvature of said curved section in the direction said operator wishes to steer said guidewire assembly, and further stiffening said curved section by advancing said stylet wire in said curved section and by keeping said stylet wire from twisting outside the plane of curvature thereby causing more of the force applied on said proximal end to be delivered in the desired forward direction, thus piercing said tissue more easily to create said extravascular pathway where percutaneously introduced grafts may subsequently be placed without surgery, and said ribbon wire providing a means of retrieving said guidewire assembly should said flexible tube break in said body.
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17. A control mechanism in the shape of a large syringe providing the means for the operator to manipulate the components of the guidewire assembly with one hand, comprising,
a. a control tube with distal end and proximal end and a lumen therebetween, b. a middle finger loop connected to said control tube c. a funnel on said distal end of said control tube reducing to be slidably larger than the circumference of said a flexible tube, d. a funnel tightening screw, e. a short tube of slidably greater circumference than a ribbon wire, f. an index finger loop attached to said short tube an slidably engaged in a slot on the side of said control tube opposite said middle finger loop, g. a short tube tightening screw, h. a semi-circular tube with end plates attached being attached to the interior wall of said control tube at all points around the periphery of said slot so as to isolate said slot from the interior of said control tube i. an opening in said end plate on the distal end of said semi-circular tube of a size to allow said short tube slidable entry and egress, j. a fluid-tight seal being between said opening in said end plate and said short tube, k. a plunger tube having a distal end and a proximal end and a lumen therebetween an being of a diameter slidably larger than that of a stylet wire, l. a plunger tube tightening screw, m. a thumb loop attached to said proximal end of said plunger tube, n. a support fixture mounted on the proximal end of said control tube with an opening slidably larger and fluid-tight with respect to said plunger tube, o. a port connection in said control tube for the introduction of contrast fluid from a reservoir, p. a flexible bulb connected to said port by a flexible tube and connected to said reservoir by a flexible tube, whereby the hollow elements of said control tube can be connected to the control elements of a guidewire assembly by tightening the screws and thus said guidewire assembly can be controlled by three digits of one hand while the other fingers can squeeze said flexible bulb to inject contrast fluid in said guidewire assembly and thus in the vessel in which said guidewire assembly is traveling intravascularly,
Specification