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
  • A61M2025/018—Catheters having a lateral opening for guiding elongated means lateral to the catheter
• • 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
  • A61M2025/0183—Rapid exchange or monorail catheters
• • 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
  • A61M2025/09058—Basic structures of guide wires
  • A61M2025/09066—Basic structures of guide wires having a coil without a core possibly combined with a sheath
• • 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
  • A61M2025/09058—Basic structures of guide wires
  • A61M2025/09083—Basic structures of guide wires having a coil around a core
• • 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 provide support to medical catheter devices that are introduced over the wire guide.
• wire guides are subjected to potentially conflicting requirements.
• Conventional 0.01 4 inch floppy wire guides are usually sufficient for navigation of moderately tortuous vessels.
• the wire guide tip may prolapse away from the catheter device which it is supporting.
• 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.
• the feeding 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 sterite 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 wire guide for intracorporeal procedures that may be easily and reliably traversed through the vasculature to a position proximate a previously introduced wire guide.
• the 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.
• the tip portion includes an insert member and a distal tip.
• the insert member is connected to the main body, and the distal tip is connected to the insert member.
• the insert member defines an insert passageway having a laterally opening proximal port.
• the distal tip defines a tip passageway having a distal port, the tip passageway being in communication with the insert passageway.
• the proximal port, insert passageway, tip passageway and distal port are sized to receive the previously introduced wire guide.
• the insert member preferably has an outer diameter less than or about equal to an outer diameter of the main body.
• the coupling wire guide is provided with a profile similar to standard (non- coupling ⁇ wire guides, while still providing a coupling function to achieve secure and reliable translation of the coupling wire guide along the previously introduced wire guide.
• the distal tip has an outer diameter about equal to the outer diameter of the insert member.
• the main body, insert member and distal tip are co-axial. It will also be recognized that the main body and distal tip may also comprise a solid or tubular mandrel, multiple wound designs or any other wire guide construction.
• a method for forming the coupling wire guide.
• the method includes the steps of providing a wire guide having a wound outer wire, stretching a distal tip portion of the wire guide to create an intermediate space, and positioning an insert member within the intermediate space.
• the main body and distal tip of the coupling wire guide are formed by a coiled outer wire.
• the stretching step generally includes increasing the pitch in the area of the intermediate space.
• the positioning step includes injection molding the insert member in the intermediate space and over the outer wire of the wire guide.
• the method may also include the step of forming an insert passageway in the insert member.
• the method may further comprise the step of forming a distal port in the distal end cap of the wire guide.
• FIG. 1 is a cross-sectional view of a coupling wire guide constructed in accordance with the teachings of the present invention
• FIG. 2 is a cross-sectional view of another coupling wire guide constructed in accordance with the teachings of the present invention.
• FIG. 3 is a cross-sectional view of yet another coupling wire guide constructed in accordance with the teachings of the present invention. Detailed Description
• FIG. 1 depicts a cross-sectional view of a coupling wire guide 20 constructed in accordance with the teachings of the present invention. While wire guides are often 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 having a proximal end 24 and a distal end 26.
• the main body 22 is constructed by an outer wire 28 which is disposed over an inner mandrel 30, preferably by winding or coiling the outer wire 28 over mandrel 30, as is well known in the art.
• the main body 22 may take many forms as many types of wire guides are known in the art, including solid wire, tubular wire, weaved or interlaced wires, coiled wires and combinations thereof, such as is shown in U.S. Patent No. 5,243,996, the disclosure of which is hereby incorporated by reference in its entirety.
• the outer wire 28 is constructed of a metal such as stainless steel or nitinol (Ni-Ti alloy), although any biocompatible material may be used.
• the coupling wire guide 20 also includes a tip portion 32 at the distal end 26 of the main body 22.
• the tip portion generally includes an insert member 34 linked to a distal tip 36.
• the insert member 34 is preferably formed of a biocompatible plastic, and most preferably a thermoplastic which may be injection molded such as polytetrafluorethylene (PTFE), polyethylene ether ketone (PEEK), polyamide, polyimide, polyurethane, polyethylene and nylon, including multi-layer or single layer constructions with or without reinforcement wires, coils or filaments.
• the distal tip 36 is constructed of a coiled wire, and preferably the same outer wire 28 of the main body 22, as will be discussed in more detail below.
• the insert member 34 generally includes a proximal end 38 connected to the distal end 26 of the main body 22, and a distal end 40 connected to the distal tip 36. It can be seen in FIG. 1 that the proximal end 38 is connected to both the outer wire 28 and the tapered end of mandrel 30. Similarly, the distal end 40 is connected to the outer wire 28 as well as a safety wire 50 forming a portion of the distal tip 36.
• the distal tip 36 generally includes a distal end cap 52 connected to the outer wire 28, as well as connected to the safety wire 50.
• the main body 22, insert member 34, and distal tip 36 are co-axially aligned. By way of this construction, torqueability of the wire guide 20 and its distal tip 36 is maintained.
• the insert member 34 includes an insert passageway 42 which defines a proximal port 44.
• the proximal portion of the insert passageway 42 is angled relative to an axis of the main body 22.
• the laterally facing proximal port 44 and angled portion of the insert passageway 42 ease the transition of a previously introduced wire guide 10 away from the coupling wire guide 20.
• the distal tip 36 defines a tip passageway 54 having a distal port 56.
• the outer wire 28 defines the tip passageway, while an aperture in the end cap 52 defines the distal port 56.
• the tip passageway 54 is in communication with the insert passageway 42 for allowing the previously introduced wire guide to pass therethrough. That is, the distal portion of insert passageway 42 opens axially to the tip passageway 54.
• the proximal port 44, insert passageway 42, tip passageway 54, and distal port 56 are sized to receive the previously introduced wire guide 10, which typically has a diameter of about .014 or .018 inches. Therefore, it can also be seen that the wire guide 20 generally has an outer diameter of about .035 to about .038 in order to provide appropriately sized passageways 42, 54 and ports 44, 56. It will be recognized by those skilled in the art that the insert member 34 has an outer diameter less than or about equal to an outer diameter of the main body 22. Likewise, the distal tip 36 has an outer diameter about equal to the outer diameter of the insert member 34. By the term “about equal”, it is generally meant that the diameters are within 1 0% of each other.
• the wire guide 20 is provided with a coupling tip portion 32 which does not have an increased diameter, thereby providing a normal profile consistent with non-coupling wire guides.
• coupling function is provided in a manner for secure and reliable interconnection of the coupling wire guide 20 to a previously introduced wire guide (not shown).
• a flexible distal tip 36 is provided to assist in the navigation of the wire guide 20, whether coupled or de-coupled from a previously introduced wire guide 1 0.
• the wire guide 120 includes a main body 1 22 having proximal and distal ends 1 24, 1 26, and defined by an outer wire 1 28 disposed over an inner mandrel 1 30.
• the insert member 1 34 includes a proximal end 138 connected to the main body 1 22, a distal end 1 40 connected to a distal tip 1 36, and defining an internal passageway 1 42 having a proximal port 144.
• the distal tip 1 36 includes an outer wire 1 28, a safety wire 1 50 and an end cap 1 52 defining the distal port 1 56.
• the safety wire 1 50 extends through a majority of the insert member 1 34 and is connected to the narrowed tip of the mandrel 1 30.
• the safety wire 1 50 and mandrel 1 30 are connected by soldering, although welding, adhesives or other well known bonding techniques may be employed. In this manner, improved torque control over the distal tip 1 36 is provided while securely connecting the main body 1 22, insert member 1 34 and distal tip 1 36.
• FIG. 3 depicts yet another embodiment of a coupling wire guide 220 constructed in accordance with the teachings of the present invention.
• the wire guide 220 includes a main body 222 having proximal and distal ends 224, 226, and defined by an outer wire 228 disposed over an inner mandrel 230.
• the insert member 234 includes a proximal end 238 connected to the main body 222, a distal end 240 connected to a distal tip 236, and defining an internal passageway 242 having a proximal port 244.
• the distal tip 236 includes an outer wire 228, a safety wire 250 and an end cap 252 defining the distal port 256.
• the mandrel 230 narrows as it approaches the insert member 234, and then itself forms the safety wire 250. That is, the mandrel 230 and safety wire 250 are unitarily formed as a single piece.
• the safety wire 250 may be formed by centerless grinding the end of the mandrel 230. As in the prior embodiment, this inter-connection of the mandrel 230 and safety wire 250 provides a secure link between the main body 222, insert member 234 and tip portion 236, while also improving torque control over the tip portion 236 for improved navigation of the coupling wire guide 220.
• the present invention also provides a method for forming a coupling wire guide in accordance with the teachings of the present invention.
• the method includes the first step of providing a wire guide having a wound outer wire. Then, a distal tip portion of the wire guide is stretched to create an intermediate space. Stated another way, a distal tip portion of the wire guide is manipulated to increase the pitch between adjacent coils in the intermediate space.
• This intermediate space is generally the space filled by the insert member 34 depicted in FIG. 1.
• the method includes positioning an insert member, such as member 34, within the intermediate space.
• the insert member is injection molded, and preferably over molded over the outer wire 28 of the wire guide. As shown in the figures, the outer wire 28 continues to traverse through the insert member 34.
• the insert member can be shaped to define an insert passageway 42 having an appropriate size for passage of a previously introduced wire guide.
• the insert passageway 42 could also be formed after the formation of the insert member 34 through any well known technique for removing material.
• the method also includes the formation of the distal port 56 in the end cap 52 using similar techniques.
• this method of the present invention permits the adaptation of existing wire guides to coupling wire guides, as well as providing a secure inter-connection between the main body 22, insert member 34 and distal tip 36.
• the coupling wire guide can be formed in many other ways, including through use of separate main body 22 and distal tip 36 pieces, which as previously discussed may take many forms.
• the coupling wire guide of the present invention is quickly and easily coupled to a previously introduced wire guide and reliably traversed through the vasculature.
• the coupling wire guide is provided with a generally constant profile that is consistent with non- coupling wire guides, thereby improving their use when not coupled to another wire guide.
• the distal tip of the wire guide is securely connected to the main body, maintaining suitable torque control for the navigation of tortuous pathways.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Biophysics (AREA)
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• Engineering & Computer Science (AREA)
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• 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)

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• 2007
  • 2007-02-26 EP EP07751579A patent/EP2117632A1/de not_active Withdrawn
  • 2007-02-26 WO PCT/US2007/004827 patent/WO2008105756A1/en active Application Filing

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