WO2010078335A1 - Fil de guidage rétrograde - Google Patents

Fil de guidage rétrograde Download PDF

Info

Publication number
WO2010078335A1
WO2010078335A1 PCT/US2009/069698 US2009069698W WO2010078335A1 WO 2010078335 A1 WO2010078335 A1 WO 2010078335A1 US 2009069698 W US2009069698 W US 2009069698W WO 2010078335 A1 WO2010078335 A1 WO 2010078335A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal end
wire guide
wire
core
coil
Prior art date
Application number
PCT/US2009/069698
Other languages
English (en)
Inventor
Robert M. Eells
Original Assignee
Cook Incorporated
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cook Incorporated filed Critical Cook Incorporated
Publication of WO2010078335A1 publication Critical patent/WO2010078335A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A61M25/09025—Guide wires with mandrils with sliding mandrils

Definitions

  • the present invention generally relates to medical devices and specifically to a wire guide for percutaneous placement of a medical device within a body cavity. Or more specifically, the present invention is directed to a wire guide that may be inserted in a first direction and then advanced in a second direction.
  • Wire guides are commonly used in vascular procedures, such as angioplasty procedures, diagnostic and interventional procedures, percutaneous access procedures, or radiological and neuroradiological procedures in general, to introduce a wide variety of medical devices into the vascular system.
  • wire guides are used for advancing intraluminal devices such as stent delivery catheters, balloon dilation catheters, atherectomy catheters, and the like within body lumens.
  • the wire guide is positioned inside the inner lumen of an introducer catheter. The wire guide is advanced out of the distal end of the introducer catheter into the patient until the distal end of the wire guide reaches the location where the interventional procedure is to be performed.
  • a stent delivery catheter is advanced over the previously introduced wire guide and into the patient until the stent delivery catheter is in the desired location. After the stent has been delivered, the stent delivery catheter can then be removed from a patient by retracting the stent delivery catheter back over the wire guide.
  • wire guides are introduced percutaneously by means of an introducer, for example through an introducer catheter, needle or dilatation catheter.
  • the introducer is generally oriented at least partially in the direction in which the wire guide is to be placed. Once positioned, the wire guide is advanced through the introducer and positioned adjacent to the desired location for treatment.
  • Some devices have previously been provided which allow a physician to employ a guide wire in a first direction via an introducer, and subsequently, redirect the guide wire and introducer in the opposite direction.
  • Such prior art retrograde-antegrade wire guides allow the physician to reverse the direction of an introducer catheter from a first direction to a second direction, and then remove the retrograde-antegrade wire guide and replace it with a conventional wire guide for use in subsequent steps in the treatment procedure.
  • these retrograde-antegrade wire guides require the performance of several steps to successfully reorient the introducer before the retrograde-antegrade wire guide can be removed and replaced with another wire guide, which increases the duration and complexity of the treatment procedure.
  • treatment may be required in locations in which access to a viable entry point is only available in a direction facing away from the desired treatment location.
  • a percutaneous entry may be available only in the direction oriented toward the abdomen.
  • Access in the desired direction within a given femoral artery may be further limited in instances in which the patient is overweight or obese.
  • physicians often treated conditions in the lower portions of the legs by inserting a wire guide into the femoral artery of one leg, directing it into the iliac artery, and then directing it down into the femoral artery of the other leg to be treated.
  • such treatment requires a longer wire guide, and also may cause trauma to both femoral arteries as well as the iliac artery. Therefore, a need exists for a method of using a wire guide and a wire guide that may be introduced through an introducer directed in a first direction while allowing the wire guide to be directed in a second, substantially different direction.
  • the present invention is directed to and discloses tools, methods and systems for using a wire guide.
  • the tools, methods and systems include a wire guide that may be inserted in a first direction and then subsequently advanced in a second direction.
  • Figure 1 shows an embodiment of an illustrative core having a pre- curved end for a wire guide according to the invention.
  • Figure 2 shows an embodiment of an illustrative flexible outer coil for a wire guide according to the invention.
  • Figure 3 shows an embodiment of a wire guide having a flexible outer coil disposed about a core having a pre-curved end according to the invention.
  • Figure 4 shows a cross-sectional view of the wire guide of Figure 3 as taken along line A-A.
  • Figure 5 depicts an embodiment of the wire guide shown in Figure 3 having the flexible outer coil advanced along the core.
  • Figure 6 shows an embodiment of a wire guide having a flexible outer coil disposed about a core having a pre-curved end being inserted into a vessel through an introducer according to the invention.
  • Figure 7 shows an embodiment of a wire guide having a flexible outer coil disposed about a core having a pre-curved end, wherein the wire - A -
  • a wire guide includes a flexible outer coil disposed about a core having a pre-curved end such that the outer coil may be advanced over the core into a patient's body cavity.
  • proximal refers to a portion of the wire guide closest to a physician when placing a wire guide in the patient
  • distal refers to a portion of the wire guide closest to the end that is or is to be inserted into the patient.
  • FIG. 1 shows an embodiment of a core 11 for use in a wire guide according to the invention.
  • the core 11 includes a proximal core end 13 that is kept outside the patient's body and a distal core tip 19 capable of being advanced into a patient's vascular system.
  • An elongated shaft 15 extends from the proximal core end 13 towards the distal core tip 19.
  • the elongated shaft 15 may carry a handle near the proximal core end 13 to allow the physician to grasp the core 11.
  • the handle may be releasably secured to the elongated shaft 15.
  • the elongated shaft 15 has a pre-curved end 17 near the distal core tip 19. In the embodiment shown in Fig.
  • the pre-curved end 17 is bent or curved through an angle of approximately 180 degrees relative to the longitudinal axis of the elongated shaft 15.
  • the pre-curved end 17 may be bent at other angles depending upon the intended use of the wire guide, including angles in the range from approximately zero degrees to approximately 180 degrees.
  • the pre-curved end 17 may be bent at an angle approximating the pre-determined takeoff angle of a particular vessel in the vascular system.
  • the core 11 may include one or more tapered sections near the distal core tip 19.
  • the core may be tapered inward along a portion of its length corresponding to the pre-curved end 17 to impart an increasing degree of flexibility to core 11 near the distal core tip 19.
  • the tapered sections may have cross-sectional areas that diminish gradually or stepwise as the distal core tip 19 is approached. The rate of taper and the starting point for the tapering may be modified, and in some instances configured to help enable smaller diameter curved ends.
  • the core 11 is formed from a suitable metal material such as medical grade stainless steel or a superelastic alloy such as Nitinol.
  • the core 11 can be formed as a wire of constant diameter.
  • the wire can be centerless ground to provide the core 11 with a decreasing cross- sectional area as the distal core tip 19 is approached.
  • the wire for the core 11 can be drawn in stages to provide a cross-sectional area that diminishes stepwise at various distances as the distal core tip 19 is approached.
  • the bend or arc in the pre-curved end 17 can be formed by an annealing method, e.g., maintaining the core 11 in the desired final shape while subjecting it to extreme heat for a prescribed period of time, or a cold working method, e.g., mechanically stressing and plastically deforming the core while in its austenitic state to create at least a partial localized zone of martensite.
  • the nitinol core can be made relatively thin while still retaining the preformed bend and the requisite stiffness.
  • Other possible materials for the core include elastic biocompatible metals such as stainless steel, titanium, or tantalum. Regardless, the core disclosed herein is not limited to these materials or manufacturing techniques and may, in some embodiments, be made of other materials including plastics or other metals and by other manufacturing techniques.
  • Figure 2 depicts an embodiment of a flexible outer coil 21 for use in a wire guide according to the invention.
  • the outer coil 21 includes a proximal coil end 23, a middle portion 25, a relaxed distal end portion 27 and a distal coil tip 29.
  • the outer coil 21 comprises a plurality of coiled loops made of round wire or other wires having suitable shapes.
  • the outer coil 21 may be formed from linear elastic materials, such as stainless steel, titanium, tantalum or superelastic alloys, such as Nitinol.
  • the pitch angle of the outer coil 21 i.e., the included angle between the longitudinal axis of the outer coil 21 and the coiled loops, preferably is less than 90 degrees.
  • the coiled loops preferably are oriented relative to the longitudinal axis of the outer coil 21 such that one half of each coiled loop is disposed closer to the distal coil tip 29 than the other half. More preferably, as shown in Figure 2, the pitch angle of the outer coil 21 at the relaxed distal end portion 27 is selected such that the distance parallel to the longitudinal axis of the outer coil 21 between the top and bottom of each coiled loop is approximately equal to the diameter of the wire forming the coiled loops.
  • the coiled loops of the relaxed distal end portion 27 may also be axially spaced apart from one another, which may desirably reduce stresses in the outer coil 21 when it is assembled around a core and stored prior to use.
  • the relaxed distal end portion 27 can have other dimensions and is not limited to the materials disclosed herein, and that other materials may be used.
  • the distal coil tip 29 ends distally at a distal end member 31 , which comprises a member having an atraumatic front end termination, such as a rounded front or a front of very flexible material or very flexible configuration.
  • the distal end member 31 is attached to the distal coil tip 29 of the outer coil 21 in a suitable manner as is known in the art, for example, by welding or soldering.
  • the distal end member may be a soldier ball.
  • the distal end member 31 may be a sphere made from a flexible material that is laser welded onto the distal coil tip 29 or a soft coil of radiopaque materials such as gold or platinum.
  • a safety wire 33 is placed within a central lumen 35 of the outer coil 21.
  • the safety wire 33 has a distal wire end 37 and a proximal wire end 39.
  • the distal wire end 37 of the safety wire 33 attaches to the distal end member 31
  • the proximal wire end 39 of the safety wire 33 attaches to the outer coil 21 , preferably at some point away from the distal coil end 29.
  • the safety wire 33 helps prevent the distal end member 31 from becoming dislodged from the outer coil 21 during use and being lost into the vasculature of the patient.
  • the safety wire 33 may help prevent the outer coil 21 from becoming elongated during use.
  • the safety wire is made from a ribbon wire, as shown in the cross-section of an embodiment of the guide wire shown in Figure 4.
  • the safety wire is not limited to ribbon wire, and could, for example, be made of round wire or other wires having other shapes.
  • the safety wire 33 may be made from any number of materials, including stainless steel and superelastic materials such as Nitinol. However, the safety wire is not limited to these materials and may, for example, be made from other metal or plastic materials.
  • FIGs 3 and 4 depict an embodiment of a wire guide 41 having the outer coil 21 disposed about the core 11.
  • the core 11 is first inserted into the lumen 35 of the outer coil 21 such that the relaxed distal end portion 27 of the outer coil 21 is disposed about the curved portion 17 of the core 11.
  • the safety wire also is disposed in the lumen 35.
  • the outer coil 21 has not yet been advanced relative to the core 11 and therefore the distal coil end 29 is adjacent to the distal core tip 19 of the core 11.
  • the proximal core end 13 extends out beyond the proximal coil end 23.
  • the safety wire 33 may be sufficiently long so that its proximal end is roughly coincident with the proximal coil end 23.
  • this relationship between the safety wire 33 and outer coil 21 is not necessary.
  • Figure 5 shows the wire guide 41 wherein the outer coil 21 has been advanced relative to the core 11 a distance 45 in a direction 47 roughly opposite to the initial direction of advancement 49 of the coil.
  • different bend or arc angles may be used for the core 11 , and therefore in other embodiments of the wire guide the direction of advancement may not be substantially opposite to the initial direction of advancement 49.
  • the physician may grasp the proximal core end 13 while pushing the proximal coil end 23 in the initial direction 49. As the physician advances the proximal coil end 23 away from the proximal core end 13, the distal coil end 29 is advanced past the distal core tip19 into the vasculature of the patient. In this manner, during use, the distal core tip 19 remains generally in the same location in the patient while the distal coil end 29 is advanced to the treatment location.
  • a handle or connector may be attached to the outer coil and or core. While the use of a handle may improve the gripability of the guide wire components, it may decrease the tactile feedback to the physician, and therefore use of a handle is a matter of preference left to physicians.
  • the outer coil and/or core may be desirable to coat the outer coil and/or core with coatings to reduce friction. These coatings generally will comprise polymeric materials, including, in some instances, fluoropolymers, however other materials may be used. Additionally, it may be desirable to include radiopaque materials in the outer coil of the guide wire to assist with placement. As noted above, the safety tip may be made from a radiopaque material, however other portions of the guide wire, and particularly the outer coil, may include radiopaque materials.
  • Figure 6 illustrates an embodiment of a method of use of a guide wire according to the invention.
  • an introducer 51 is inserted into a body cavity 55 of a patient through a percutaneous entry 53.
  • An embodiment of the wire guide 41 is then inserted through the introducer 51 into the body cavity 55 of the patient.
  • the wire guide may be preloaded into the introducer.
  • the introducer 51 may, for example, consist of an introducer catheter, a needle or a dilatation catheter.
  • other devices may be used to introduce the wire guide 41 into the patient's body cavity.
  • the wire guide may be introduced through the working channel of an endoscope that has been introduced into the patient via a natural passageway of the patient, such as the esophagus or colon.
  • the wire guide 41 may be introduced into the patient subsequent to the placement of a standard wire guide if it becomes necessary to change the advancement orientation of the wire guide.
  • the body cavity 55 is depicted as a blood vessel.
  • the term "vessel" is used herein to refer to a part of the vascular system such as an artery or vein.
  • the physician positions the curved end of the wire guide through the introducer 51 such that the pre-curved end 17 and distal core tip 19 of the core are located inside the body cavity 55 and directed in a different direction of advancement 57.
  • the direction of advancement 57 is substantially opposite to the direction of blood flow (indicated by arrow 59).
  • the physician grasps in one hand the shaft 15 of the core 11 near the proximal core end 13, and then grasps the outer coil 21 near its proximal coil end 23 and pushes the proximal coil end 23 in the direction of advancement 57. The physician continues to advance the outer coil 21 over the core 11 until the distal coil tip 29 is placed proximal to or just past the location to be treated.
  • the wire guide 41 is inserted through the introducer 51 at a percutaneous entry 53 into the femoral artery of a patient in order to treat a lesion located in the patient's lower leg (that is, nearer the patient's foot than the percutaneous entry 53).
  • the outer coil 21 is advanced over the core 11.
  • the physician advances the outer coil 21 until the distal coil tip 29 is positioned proximal to or beyond the lesion so that a treatment device may be run over the outer coil 21 proximal to the lesion in order to apply a treatment.
  • a catheter may be run over the outer coil 21 to place a stent in a stenosis in the patient's lower leg.
  • an introducer 51 is inserted into a body cavity 55 through a percutaneous entry 53.
  • a wire guide 41 is then inserted into the body cavity 55 through the introducer 51.
  • the wire guide 41 is then advanced as a unit (that is, both the core 11 and outer coil 21 are moved in unison) to a point within the body cavity 55.
  • the wire guide 41 would be moved in unison until the pre-curved end 17 and distal core tip 19 of the core 11 and the distal coil tip 29 are adjacent a branching 61 within the body cavity 55. Once positioned at the branching 61 , the outer coil 21 is advanced over the core 11 in a direction of advancement 63.
  • this direction of advancement 63 is substantially opposite to a positioning direction 65.
  • the advancement direction may be oriented at any angle with respect to the positioning direction.
  • the positioning of the wire guide may be verified by taking images, such as x-rays, showing that the radiopaque material or safety tip in such a position that the physician can be certain that the wire guide extends far enough for the desired treatment device to be positioned at the site to be treated.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention porte sur des fils de guidage et sur des procédés d'utilisation des fils de guidage. Les procédés consistent à introduire un introducteur dans le système vasculaire dans une première direction générale, introduire dans le système vasculaire un fil de guidage comprenant une bobine souple extérieure disposée autour d'un noyau ayant une extrémité distale pré-incurvée à l'aide de l'introducteur de telle sorte que l'extrémité distale pré-incurvée du noyau soit positionnée dans un vaisseau du corps, et la faire avancer la bobine souple extérieure sur le noyau de telle sorte que la bobine souple extérieure soit amenée à progresser derrière l'extrémité distale pré-incurvée dans une seconde direction différente de la première direction.
PCT/US2009/069698 2008-12-31 2009-12-29 Fil de guidage rétrograde WO2010078335A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14191008P 2008-12-31 2008-12-31
US61/141,910 2008-12-31

Publications (1)

Publication Number Publication Date
WO2010078335A1 true WO2010078335A1 (fr) 2010-07-08

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Family Applications (1)

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PCT/US2009/069698 WO2010078335A1 (fr) 2008-12-31 2009-12-29 Fil de guidage rétrograde

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WO (1) WO2010078335A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2656870A1 (fr) 2012-04-26 2013-10-30 Asahi Intecc Co., Ltd. Fil de guidage
US9089675B2 (en) 2009-04-24 2015-07-28 Imds R&D Bv Guidewire support system and guidewire

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0778043A1 (fr) * 1995-12-04 1997-06-11 Pacesetter AB Fil de guidage comprenant un fil interne en alliage à memoire de forme
EP0860177A2 (fr) * 1997-02-21 1998-08-26 Cordis Corporation Bout de fil de guidage avec la capacité de changer sa forme dans un vaisseau
EP1195174A1 (fr) * 2000-10-03 2002-04-10 William Cook Europe ApS Fil de guidage et procédé pour l'introduction d'un fil de guidage

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0778043A1 (fr) * 1995-12-04 1997-06-11 Pacesetter AB Fil de guidage comprenant un fil interne en alliage à memoire de forme
EP0860177A2 (fr) * 1997-02-21 1998-08-26 Cordis Corporation Bout de fil de guidage avec la capacité de changer sa forme dans un vaisseau
EP1195174A1 (fr) * 2000-10-03 2002-04-10 William Cook Europe ApS Fil de guidage et procédé pour l'introduction d'un fil de guidage

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9089675B2 (en) 2009-04-24 2015-07-28 Imds R&D Bv Guidewire support system and guidewire
EP2656870A1 (fr) 2012-04-26 2013-10-30 Asahi Intecc Co., Ltd. Fil de guidage
US9492641B2 (en) 2012-04-26 2016-11-15 Asahi Intecc Co., Ltd. Guidewire

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