Steering, piercing, anchoring, distending extravascular guidewire

• US 7,713,215 B2
• Filed: 01/31/2008
• Issued: 05/11/2010
• Est. Priority Date: 01/31/2008
• Status: Expired due to Fees

• Current Assignee: Edgar L. Shriver
• Original Assignee: Edgar L. Shriver
• Inventors: Shriver, Edgar L.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Foreman; Jonathan M.
• Application Number:
  US12/012,086
• Publication Number:
  US 20090198153A1
• Time in Patent Office: 831 Days
• Field of Search: 600/433, 600/434, 600/585, 604/164.13
• US Class Current: 600/585
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/2911 rings
• CPC Class Codes: A61B 2017/2924 Translation movement of handle without rotating movement
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires

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.

Claims

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, nickel titanium alloy 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,

e. at least one hanger for holding said ribbon wire having the same shape and slidably larger than the ribbon wire attached to the proximal end of the flexible tube;

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.

2. The guidewire assembly of claim 1 further including,

a shape of said sharp point of said stylet wire being an oblique section which produces a face to said sharp point,

whereby a force lateral to the direction of movement on said face is exerted by movement through tissue.

3. The guidewire assembly of claim 1 further including,

a shape of said sharp point of said stylet wire being conical,

whereby movement through tissue exerts no force on said sharp point in any lateral direction with respect to the direction of movement of said sharp point.

4. The guidewire assembly of claim 1, further including,

a taper section between said distal end and said proximal end of said stylet wire with said taper section being ground, or otherwise modified during manufacture, to be smaller in cross-sectional size and/or of different in shape in cross-section in the section toward said distal end of said stylet wire than in the section toward said proximal end of said stylet wire,

whereby a different amount of stiffness is imparted to said guidewire assembly. by said stylet wire in said proximal, distal and taper sections.

5. The guidewire assembly of claim 1 further including,

a linear section toward said distal end of said guidewire assembly, such as said ribbon wire, being made of radiodense material,

whereby said linear section of radiodense material can be distinguished as a bright image on a fluro-unit screen, in contrast to a dark radiopaque image from a contrast filled vessel when the images are co-incident on said screen.

6. The guidewire assembly of claim 1 further including,

a spherical exterior shape on said hollow tip,

whereby said hollow tip of said spherical shape may be preferred by physicians who regard a patient in a particular case to benefit from use of this shape which may be safer during intravascular travel.

7. The guidewire assembly of claim 1 further including,

a beveled exterior shape of said hollow tip,

whereby said hollow tip may be preferred by physicians who regard a patient in a particular case to benefit from use of this shape which may be more effective during extravascular travel.

8. The guidewire of claim 1 further including;

a lubricious coating such as PTFE on all or part of said guidewire assembly including said hollow tip, said stylet wire and said ribbon wire,

whereby a given amount of force delivered at the proximal end of said guidewire assembly will move the distal end of said guidewire assembly more easily and movement of elements in slidable contact with each other will move with less force applied.

9. The guidewire assembly of claim 1, further including,

a shape of said stylet wire where generally width is greater than thickness from proximal to distal end but specifically at said distal end of said stylet wire,

whereby resistance is increased to lateral movement outside the plane of said radius of curvature of said guidewire assembly and thus a maximum percentage of the force of pushing said proximal end of said stylet wire is transferred to said distal end of said stylet wire to force said sharp point through tissue, and rotational torque applied to said proximal end of said stylet wire is maximally delivered to said hollow tip and thus to said flexible tube, thereby avoiding the problem of rotational energy being delivered intermittently as in a wire coil.

10. The guidewire assembly of claim 1, further comprising,

a shape at said distal end of said stylet wire of circular cross-sectional and slidably smaller than said exit tunnel of said hollow tip,

whereby rotational torque applied to said stylet wire, delivers essentially none of said rotational torque to said hollow tip and operator can utilize said lateral force on said face of said sharp point in steering said guidewire assembly without rotating said guidewire assembly.

11. The guidewire assembly of claim 1, further including:

a replacement wire for vessel anchoring that replaces said stylet wire in said guidewire assembly and anchors itself in a peripheral artery, comprising,

a. a replacement wire for vessel anchoring impressed with a shape memory larger than the vessel anchoring replacement wire diameter,

b. said vessel anchoring replacement wire replacing said stylet wire in said guidewire assembly,

c. an inner core of said the vessel anchoring replacement wire that extends throughout its length,

d. a vessel anchoring replacement wire of a polymer such as oligodial with a shape memory that shape shifts when heated to just above body temperature or by electrical stimulus,

e. said inner core of said vessel anchoring replacement wire being made of a metal that conducts electricity,

whereby said vessel anchoring wire with shape memory wire replaces said stylet wire in said guidewire assembly an anchors said guidewire assembly in a vessel such as a peripheral artery by being advanced through said lumen of said guidewire assembly which is in said pathway created by said guidewire assembly ending at the distal site on said vessel where said vessel anchoring replacement wire it advanced through the vessel wall and an electrical circuit is completed between said electrical conductor in said inner core and the metal of said ribbon wire and/or said flexible tube thus shape shifting said vessel anchoring replacement wire, thereby anchoring said replacement wire and said guidewire assembly to said distal site on said peripheral artery.

12. The guidewire assembly of claim 1, further including:

a replacement wire for vessel anchoring that replaces said stylet wire in said guidewire assembly and anchors itself in a peripheral artery, comprising,

a. a replacement wire for vessel anchoring impressed with a shape memory larger than the vessel anchoring replacement wire diameter,

b. said vessel anchoring replacement wire replacing said stylet wire in said guidewire assembly,

c. an inner core of said the vessel anchoring replacement wire that extends throughout its length,

d. a vessel anchoring replacement wire of a material that is an electrical insulator

e. said inner core of said vessel anchoring replacement wire being made of a metal such a nickel titanium alloy with a shape memory that shape shifts when heated to above body temperature or by electrical stimulus,

whereby said vessel anchoring wire with shape memory wire as said inner core replaces said stylet wire in said guidewire assembly an anchors said guidewire assembly in a vessel such as a peripheral artery by being advanced through said lumen of said guidewire assembly which is in said pathway created by said guidewire assembly ending at the distal site on said vessel where said vessel anchoring replacement wire it advanced through the vessel wall and an electrical circuit is completed between said electrical conducting metal in said inner core and the metal of said ribbon wire and/or said flexible tube thus shape shifting said vessel anchoring replacement wire, thereby anchoring said replacement wire and said guidewire assembly to said distal site on said peripheral artery.

13. The guidewire assembly of claim 1, further including:

a replacement wire for skin anchoring being of smaller diameter than said stylet wire and capable of being attached to said guidewire assembly after said guidewire assembly has created said pathway and pierced skin to exit said body at a pre selected distal site,

whereby said replacement wire for skin anchoring is drawn by said guidewire assembly through said pathway created by said guidewire assembly from a pre selected distal site on the said skin through the intravascular and extra vascular path of said guidewire assembly to the site of percutaneous entry where both ends of said replacement wire for skin anchoring are anchored by a common clamp, thereby providing a wire for guiding the delivery of a bypass graft on an occluded vessel such as a peripheral artery.