Source: http://www.google.com/patents/US6371928?dq=7,346,545
Timestamp: 2014-08-29 05:45:12
Document Index: 701428058

Matched Legal Cases: ['application No. 60', 'application No. 60', 'application No. 60', 'application No. 60', 'application no. 60', 'application No. 60', 'application No. 60']

Patent US6371928 - Guidewire for positioning a catheter against a lumen wall - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe present invention relates to a guidewire having a shaped three dimensional guide section. In the preferred embodiment the guide section is helical, and exerts an outward radial force on a lumen the guidewire is constrained in. The outward radial force can be measured or calculated according to methods...http://www.google.com/patents/US6371928?utm_source=gb-gplus-sharePatent US6371928 - Guidewire for positioning a catheter against a lumen wallAdvanced Patent SearchPublication numberUS6371928 B1Publication typeGrantApplication numberUS 09/417,228Publication dateApr 16, 2002Filing dateOct 13, 1999Priority dateNov 7, 1997Fee statusLapsedAlso published asUS20020103446, WO2001026725A1Publication number09417228, 417228, US 6371928 B1, US 6371928B1, US-B1-6371928, US6371928 B1, US6371928B1InventorsTimothy B. McFann, Kathy M. Mah, James D. Passafaro, Roger W. Perkins, Joan Huynh, Greg R. Patterson, Ronald G. Williams, David J. KupieckiOriginal AssigneeProlifix Medical, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (75), Referenced by (26), Classifications (23), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetGuidewire for positioning a catheter against a lumen wallUS 6371928 B1Abstract The present invention relates to a guidewire having a shaped three dimensional guide section. In the preferred embodiment the guide section is helical, and exerts an outward radial force on a lumen the guidewire is constrained in. The outward radial force can be measured or calculated according to methods of the present invention. Also described is a system comprising a guidewire and catheter where the force the catheter exerts on a body lumen can also be calculated. Apparatus and methods of making the guidewire are also disclosed, as well as alternative embodiments of the guidewire.
CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. application Ser. No. 09/289,850, filed Apr. 12, 1999, which claimed the benefit of U.S. provisional application No. 60/081,631 filed Apr. 13, 1998; U.S. provisional application No. 60/081,614 filed Apr. 13, 1998; and U.S. provisional application No. 60/103,447 filed Oct. 7, 1998; which is a continuation-in-part of U.S. application Ser. No. 08/966,001 filed Nov. 7, 1997, now U.S. Pat. No. 6,156,046; which is a continuation-in-part of U.S. application Ser. No. 09/290,510 filed Apr. 12, 1999 now U.S. Pat. No. 6,139,557, which claimed the benefit of U.S. provisional application No. 60/081,631 filed Apr. 13, 1998; U.S. provisional application no. 60/081,614 filed Apr. 13, 1998; and U.S. provisional application No. 60/103,447 filed Oct. 7, 1998; now U.S. Pat. No. 6,139,557; and which is a continuation-in-part of U.S. application Ser. No. 09/389,772 filed Sep. 3, 1999, of which claimed the benefit of U.S. provisional application No. 60/099,079 filed Sep. 4, 1998. The full disclosures of each of these prior regular and provisional applications are incorporated herein by reference.
SUMMARY OF THE INVENTION The present invention relates to medical wires, specifically guidewires and perfusion wires. In general the wires share a generally straight proximal section and a distal section having a curved three dimensional profile. The three dimensional profile usually defines a helical section having a relaxed diameter and a constrained diameter. The use of various materials and manufacturing techniques produces the variety of wires disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A shows a plan view of a unconstrained guide section.
While common guidewire terminology is used herein, clarification of certain terms are necessary. Terms used in the field of guidewire manufacturing and guidewire usage often vary among physicians and practitioners. The present invention is designed to take a straight core wire and reshape it into a form suitable for use in interventional procedures. The �core wire� is the back bone of a guidewire. Frequently made from a bio-compatible alloys such as stainless steel or nickel-titanium, these wires are usually larger at the proximal side and tapered to a thinner diameter at the distal end. The taper of the guidewire can be constant along the length, or broken up into transition lengths. Along the distal tip of the guidewire, a small coil is often slid over and secured to the core wire. The small wire which is used to make the coil is referred to herein as the �filament wire.� The diameter of a regular guidewire used in cardiology procedures at the present time is generally about 0.014.″ For purposes of discussion the core wires used in the present invention follow the same geometries of the core wires used in other guidewires.
A tapered core wire is used as the starting material for making a guidewire having a three dimensional profile. By �three dimensional profile� we refer to the shape the wire assumes after it has gone through the procedure detailed below. Once the shape setting step is complete, the core wire can be modified as any other guidewire may be by techniques well understood in the art. While most guidewires are used to guide a catheter from a point of entry from outside a patients body to a desired location, the guidewire of the present invention is preferably utilized to direct a catheter to precise locations in a body lumen after the catheter has already been guided to the general site of interest using a standard guidewire. The present invention may be used for both introducing the catheter and for localized guidance if the guidewire is composed of a two way shape memory material.
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By �outward radial force� the description means a force exerted by a compressed helical guide section as it seeks to recover the strain it has experienced while being compressed. There are two predominate sources for compression of the helical guide section. First the helical guide section may be deployed within a lumen having a smaller diameter than the unconstrained diameter of the helical guide section. Under this condition the entire helical guide section may experience a uniform compression or constraining force preventing the helical guide section from releasing the strain energy it possesses. The outward radial force can be uniform along the entire length of the helical guide section, or can vary based on the amount of compression the guide section is experiencing. The second manner a guide section experiences compression, causing an outward radial force, is when a catheter tracking over the guide section causes further compression of the guide section. As the catheter advances, local deformations immediately proximal and distal to the catheter appear on the length of the guide section. These deformations are the result of the strain the catheter exerts on the guidewire as it is advanced. The guide section seeks to resist deformation and recover the strain to return to its natural, relaxed shape. Any force the guide section exerts as it seeks to recover its natural state is an �outward radial force� with respect to the intended operation and usage of the present invention. The outward radial force of the guide section less the beam stiffness of the catheter and the adjustments for the local deformations of the guidewire as the catheter is tracking over it constitute the value (Peff).
Peff=(((EgIg)Faδa)/(2StotRkRoR2))� (Leff)+EgIg[((1/Ro)−(1/Ro)− (1/R))((1/RoR2))]�+((96Fa 2R2N)/(d4G))−((3(EcIc)δc)/(Lc 3)). Wherein the variables are defined above.
The axial force (Fa) can be expressed as Fa=kδa, where k is the axial spring constant for the helical guide section 202. As such, Fa can be written in terms of R. Alternately, δa and Fa can be determined empirically as a function of R: The axial force is measured by placing the guide section 202 in a force-displacement measuring instrument (such as an Instron� model 5543, using a 10-pound load cell). The guide section 202 is subject to a standard axial force displacement test, with the ends of the guide section 202 fixed in rotation. The load cell of the Instron� is slowly moved apart so that the guide section 202 of the guide section 202 is slowly stretched. The Instron� can be programmed to measure on an incremental basis the force required to stretch the guide section 202. For example, if the guide section 202 is stretched at a rate of 1 cm per minute, force measurements can be taken every millimeter or every six seconds. Once the guide section 202 is extended to a point such that the guide section 202 is substantially straight, the test should be stopped.
Following completion of the axial force and displacement testing, the guide section 202 is removed from the Instron� and the radius of the guide section 202 measured using an optical measurement device. The guide section 202 is displaced axially with the ends of the guide wire fixed in rotation. The radius R is recorded at axial displacements δa corresponding to those at which the axial displacement δa and axial force Fa measurements were taken.
Peff=(((EgIg)Faδa)/(2StotRkRoR2))�(Leff)+EgIg[((1/Ro)−(1/R))((1/RoR2)− (1/RcR2))]�+((96Fa 2R2N)/(d4G))−((3(EcIc)δc)/(Lc 3)) The equation for Peff is comprised of four terms: the first three terms are expressions of the outward radial force the helical guide section 202 exerts on the distal end of the catheter 406, the fourth term is the resistive force of the catheter due to its beam stiffness. Subtracting the resistive force of the catheter from the total force exerted outwardly by the helical guide section 202 on the catheter 400 results in the net force of the distal end of the catheter 406 against the lumen wall 302. If Peff is positive the catheter 400 is exerting an outward force on the wall of the lumen 302. If Peff is zero the resistive force of the catheter distal tip 402 is balanced with the outward radial force the helical guide section 202 is exerting on the catheter distal tip 402 and the catheter distal tip 402 is resting on the wall of the lumen 302 but not exerting any force on the wall of the lumen 302. If Peff is negative the resistive force of the catheter exceeds the outward force of the helical guide section 202 on the catheter distal tip 402 and the catheter distal tip 402 is no longer in contact with the wall of the lumen 302.
To measure the force of the catheter, mount the catheter 400 in an instrument capable of measuring force and deflection (e.g., an Instron�), with the catheter 400 having an effective beam length L discussed above. The catheter 400 must be prepared such that its stiffness will be that seen during its use. Thus if the guide section 202 passes through a lumen in the catheter during use, the guide section 202 must be inserted into the catheter 400 prior to testing in such a way that the guide section 202 contributes to the stiffness of the catheter 400 but does not externally restrict the deflection of the catheter 400. Measure and record the force required to deflect the catheter orthogonal to its major axis from zero deflection (its natural, free state) to a deflection at a minimum equal to the greatest free state radius of the largest guide section 202 intended for use with this catheter 400.
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