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
  • A61M25/0905—Guide wires extendable, e.g. mechanisms for extension
• • 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
  • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

• This invention relates generally to a wire guide for use in intracorporeal procedures, and more particularly relates to the construction of a wire guide to be coupled to a previously introduced wire guide for assistance during interventional procedures in vessels with proximal tortuosity, or as a more substantial wire guide for angioplasty procedures, stenting procedures, and other device placement procedures and their related devices.
• Wire guides are therefore typically used to navigate the vasculature of a patient during percutaneous interventional procedures. Once the wire guide has been introduced, it may then be used to introduce one or more medical catheter devices. Thus, most wire guides are typically 0.014 inches in diameter and have a lubricious coating to enhance wire guide introduction movement. Conventional 0.014 inch floppy wire guides must have sufficient flexibility and torque control for navigation through tortuous vessels. At the same time, the wire guide must have a certain amount of rigidity to pass through lesions, straighten extremely tortuous vessels, and support medical catheter devices that are introduced over the wire guide.
• wire guides are subjected to potentially conflicting requirements.
• Conventional 0.014 inch floppy wire guides are usually sufficient for navigation of moderately tortuous vessels.
• the wire guide tip may prolapse away from the site to which it is guiding the device.
• balloon angioplasty in vessels with proximal tortuosity has been associated with a higher incidence of acute complications and procedural failure due to the inability to cross lesions with a conventional floppy wire guide, and due to the inability of the wire guide to provide adequate support to the balloon catheter.
• Heavy-duty wire guides are generally not well suited as primary wire guides because of their stiffness and potential for causing injury to the vessel during introduction.
• a supplemental wire guide will straighten out the vessel curves and ease further wire guide movement. Additionally, the supplemental wire guide provides greater support and enhances the tracking of balloons, stents, stent delivery devices, atherectomy devices, and other medical catheter devices as compared to a conventional floppy wire guide.
• This technique is commonly referred to as the "Buddy Wire” technique, details of which are disclosed in U.S. Patent Application Serial No. 1 1 /081 , 146,(US 2005-0209533) filed March 16, 2005.
• the navigation of the supplemental wire guide parallel to the first wire guide is an exacting and time consuming process in which additional difficulties are encountered.
• the second wire guide can cork screw or coil around the first wire guide, which may result in immobilization or unintended movement of the first wire guide, which in turn may require the retraction and re-feeding of the supplemental wire guide and/or the primary wire guide.
• either of the wire guides may become contaminated and the entire process may need to be restarted with sterile components.
• the time consumed by this process can be critical to the success of the procedure.
• the larger open space of the heart makes identical placement of the supplemental wire guide somewhat difficult.
• the present invention provides a supporting wire guide for intracorporeal procedures that may be easily and reliably traversed through a body lumen to a position proximate a previously introduced wire guide.
• the supporting wire guide is a coupling wire guide that is structured to be slidably coupled to the previously introduced wire guide.
• the coupling wire guide generally includes a main body and a tip portion connected to the distal end of the main body.
• the tip portion includes a coupling head defining a coupling passageway.
• the coupling head is operable between at least two positions including a first position generally aligned with the main body and a second position non-aligned with the main body.
• the tip portion is preferably constructed of a resilient material, and most preferably a plastic overmolded onto the distal end of the main body.
• the tip portion includes a neck connected to the coupling head which flexes to permit the coupling head to transition between the first and second positions.
• the neck has an outer diameter that is less than the outer diameter of the coupling head, and preferably includes one or more radially facing depressions to create a predetermined path along which the coupling head flexes between the first and second positions.
• An outer diameter of the coupling head is about equal to or less than the largest diameter of the remainder of the tip portion, thereby improving placement and translation of the coupling wire guide when not coupled to a previously introduced wire guide.
• the coupling head is biased towards the first position.
• the coupling passageway is generally parallel to the distal end of the main body in the second position to promote smooth translation along the previously introduced wire guide.
• the coupling passageway defines a passageway axis while the main body includes a central axis. In the first position, the passageway axis is angled relative to the central axis, and in the second position, the passageway axis is generally parallel with the central axis. Preferably, the passageway axis is angled less than 45 degrees relative to the central axis when in the first position.
• FlG. 1 is a perspective view of a coupling wire guide constructed in accordance with the teachings of the present invention. - A -
• FIG. 2 is a cross-sectional view of the coupling wire guide shown in FIG. 1 ;
• FIG. 3 is another cross-sectional view of the coupling wire guide shown in FIG.
• FIG. 4 is a cross-sectional view of another coupling wire guide constructed in accordance with the teachings of the present invention.
• FIG. 5 is a different cross-sectional view of the coupling wire guide shown in FIG. 4.
• FIG. 6 is a cross-sectional view of another coupling wire guide constructed in accordance with the teachings of the present invention.
• FIG. 7 is a different cross-sectional view of the coupling wire guide shown in FIG. 6.
• FIGS. 1 to 3 depict a coupling wire guide 20 constructed in accordance with the teachings of the present invention.
• the coupling wire guide 20 is easily and reliably coupled to and traversed along a previously introduced wire guide 10, and also is easily used alone by maintaining a relatively low profile when decoupled. While wire guides are generally used in percutaneous interventional procedures, it will be recognized by those skilled in the art that the wire guide of the present invention may also be employed non-percutaneously, such as in endoscopic or other intracorporeal procedures.
• the coupling wire guide 20 generally includes a main body 22 and a tip portion 24.
• the tip portion includes an attachment section 26, a neck 28 and a coupling head 30.
• the coupling head 30 defines a coupling passageway 32 having a distal port 34 and a proximal port 36 through which the previously introduced wire guide 10 passes, as shown in FIG. 3.
• the main body 22 generally comprises a coiled wire 38 disposed over a mandrel 40, a structure well known in the art.
• the previously introduced wire guide 10, as well as the main body 22 of the coupling wire guide 20 may take numerous forms as many types of wire guides are known in the art, including solid wire, tubular wires, coiled wires and combinations thereof.
• U.S. Pat. No. 5,243,996 discloses an exemplary solid wire mandrel having a coil tip section.
• a distal end 42 of the main body 22 is connected to the attachment section 26 of the tip portion 24.
• the methods and materials used to inter-connect attachment section 26 and distal end 42 will vary depending upon the configuration and type of material utilized for the main body 22 and the tip portion 24.
• the tip portion 24 and its attachment section 26 have been depicted as a plastic material, and preferably a biocompatible thermoplastic which may be injection molded.
• Preferable materials include polytetrafluorethylene (PTFE), expanded polytetrafluorethylene (EPTFE), polyethylene ether ketone (PEEK), polyvinylchloride (PVC), polyamide including Nylon ® , polyimide, polyurethane, polyethylene (high, medium or low density), and elastomers such as Santoprene ® , including multi-layer or single layer constructions with or without reinforcement wires, coils or filaments.
• the attachment section 26 may be overmolded directly onto the distal end 42 of the main body 22. It will be recognized that in the overmolding process, the plastic material forming the attachment section 26 will be allowed to flow in between and around the coils of wire 38 to provide a secure inter-connection of the main body 22 and tip portion 24. . .
• attachment section 26 may be soldered or welded to the distal end 42, or may inter-connected through other mechanical means such as clamping, latching, fasteners, material deformation techniques and the like.
• the tip portion 24 includes a neck 28 linking the attachment section 26 to the coupling head 30.
• the neck 28 preferably includes a first radially facing depression 44 and a second radially facing depression 46.
• the neck thus has an outer diameter less than an outer diameter of the coupling head 30.
• the neck 28 is constructed of a resilient but flexible material such that the coupling head 30 may take a decoupled or first position depicted in FIG. 2, but yet may be rotated, pivoted, or otherwise transitioned to a second position depicted in FIG. 3.
• the shape of the neck 28 and particularly the depressions 44, 46 assist in providing this flexibility and determining the path of transition between the first and second positions depicted in FIGS. 2 and 3, respectively. Specifically, these depressions 44, 46 may take various sizes and shapes to determine the path followed by the head 30 between the first and second positions.
• the coupling head 30 is aligned with the main body 22 in the first position (FIG. 2), and is generally non-aligned (and offset from) the main body 22 in the second position (FIG. 3). That is, the coupling head 30 is generally in-line with a central axis 23 of the main body 22 in the first position, but is positioned radially away from the central axis 23 in the second position.
• the first depression 44 faces away from the second position (FIG. 3) of the coupling head 30, while the second depression 46 faces towards the second position of the coupling head 30. Due to the resilient nature of the neck 28 and coupling head 30, the coupling head 30 is generally biased towards the first position when decoupled from a previously introduced wire guide 10.
• the outer diameter of the coupling head 30 is about equal to or less than the largest diameter of the remainder of the tip portion 24, namely the attachment section 26.
• the coupling wire guide 20 is easily used as a single wire guide having a coupling tip portion 24 that is generally aligned with the main body 22 while maintaining a consistent profile or outer diameter.
• the coupling passageway 32 takes a position which eases transition of the coupling wire guide 20 along the previously introduced wire guide 10. It can be seen that the coupling passageway 32 is positioned radially outside the distal end 42 of the main body 22 in the second position.
• the coupling passageway 32 defines a passageway axis 33 which is angled relative to the central axis 23 of the main body 22. Preferably, this angle is less than 45 degrees and most preferably about 15 to 30 degrees such that the coupling head 30 only needs to rotate about 45 degrees or less to the second position.
• the passageway axis 33 is generally parallel with the central axis 23 of the main body 22.
• the coupling wire guide 20 may be translated in a generally parallel fashion along the previously introduced wire guide 10 while minimizing any deformation or bending of the previously introduced wire guide 10.
• FIGS. 4 and 5 Another embodiment of a coupling wire guide 120 is depicted in FIGS. 4 and 5. Similar to the prior embodiment, the coupling wire guide 1 20 includes a main body 1 22 and a tip portion 124.
• the tip portion 124 includes an attachment section 126, a neck 128 and a coupling head 130 which transitions between a first position depicted in FIG. 4 and a second coupling position depicted in FIG. 5.
• the coupling head 1 30 defines a coupling passageway 132 having an axis 133 which is angled relative to the central axis of the main body 122 in the first position, but generally parallel to the central axis in the second position.
• the main body 122 again includes an outer wire 138 disposed over a inner mandrel 140, and having a distal end 142 which is connected to the attachment section 126 of the tip portion 124.
• the neck 128 includes first and second depression 144, 146 much like the prior embodiment, however the first depression 144 generally faces the second position of the coupling head 130. That is, the coupling passageway 132 opens towards the larger first depression 144, thereby providing greater access to the proximal port 136. At the same time, the neck 1 28 must provide greater flexibility and the coupling head 130 must bend a bit more than the prior embodiment, although the angled rotation of the passageway 132 is somewhat less than the prior embodiment. It will be recognized by those skilled in the art that numerous embodiments of the present invention are possible, both through the use of materials different than those described here, as well as through numerous shapes and orientations of the coupling tip and its pivoting head.
• the coupling wire guide 220 generally includes a main body 222 and a tip portion 224.
• the tip portion 224 includes an attachment section 226, a neck 228 and a coupling head 230.
• the coupling head 230 defines a coupling passageway 232 having a distal port 234 and a proximal port 236 through which the previously introduced wire guide 210 passes, as shown in FIG. 7.
• the main body 222 of the coupling wire guide 220 generally comprises a coiled wire 238 disposed over a mandrel 240.
• a distal end 242 of the main body 222 is connected to the attachment section 226 of the tip portion 224.
• the neck 228 of the tip portion 224 links the attachment section 226 to the coupling head 230.
• the neck 228 again includes a first radially facing depression 244 and a second radially facing depression 246.
• the neck 228 is reinforced with a securing member 241.
• the securing member 241 is an extension of the mandrel 240. That is, the distal end of the mandrel 240 has been formed with a reduced diameter portion that protrudes beyond the outer coiled wire 238, and over which the tip portion 224 is formed. As shown, the securing member 241 extends through the neck 228, along side the coupling passageway 232, and partially into the coupling head 230.
• the securing member 241 is structured (such as through sizing or material selection) to retain the flexible nature of the neck 228 and permit transition between the first decoupled position (FIG. 6) and the second coupled position (FIG. 7), while at the same time providing additional strength to the neck 228 and passageway 232.
• the securing member 241 may take many forms.
• the outer wire 238 could be extended into the neck 228 and/or coupling head 230 instead of the mandrel 240.
• the securing member 241 may be separately formed and attached to either the mandrel 240 and/or the outer wire 238, or not attached at all.
• the securing member 241 can be made of various metals, alloys, plastics or combinations thereof (e.g., a plastic could be selected that is stiffer or stronger than that used for the coupling tip).
• the main body 222 can take many forms, and likewise the securing member 241 may also take many forms and shapes.
• the coupling wire guide of the present invention provides secure coupling to a previously introduced wire guide with easy and reliable translation along the previously introduced wire guide.
• the wire guide has an uncoupled position where the coupling tip maintains an aligned and generally low profile to improve maneuverability of the coupling wire guide when decoupled.
• the tip portion itself bends to permit the coupling wire guide and previously introduced wire guide to be aligned generally and parallel for smooth translation of the two guides relative to one another. In this manner, the previously introduced wire guide does not need to bend or deform in order to couple and translate the two wire guides relative to one another.

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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)
• Surgical Instruments (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

Family

ID=38051819

Family Applications (1)

Country Status (7)

Cited By (11)

Families Citing this family (7)

Citations (5)

Family Cites Families (109)

• 2007
  • 2007-01-11 US US11/652,430 patent/US7811238B2/en active Active
  • 2007-01-16 JP JP2008550459A patent/JP5044570B2/ja not_active Expired - Fee Related
  • 2007-01-16 AU AU2007207632A patent/AU2007207632B2/en active Active
  • 2007-01-16 EP EP07716651A patent/EP1976587B1/en active Active
  • 2007-01-16 DE DE602007002982T patent/DE602007002982D1/de active Active
  • 2007-01-16 WO PCT/US2007/001066 patent/WO2007084474A1/en not_active Ceased
  • 2007-01-16 AT AT07716651T patent/ATE446782T1/de not_active IP Right Cessation

Patent Citations (5)

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