WO2023060187A1 - Fil-guide multi-segmenté - Google Patents

Fil-guide multi-segmenté Download PDF

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Publication number
WO2023060187A1
WO2023060187A1 PCT/US2022/077689 US2022077689W WO2023060187A1 WO 2023060187 A1 WO2023060187 A1 WO 2023060187A1 US 2022077689 W US2022077689 W US 2022077689W WO 2023060187 A1 WO2023060187 A1 WO 2023060187A1
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WO
WIPO (PCT)
Prior art keywords
segment
guidewire
mid
distal
segmented
Prior art date
Application number
PCT/US2022/077689
Other languages
English (en)
Inventor
Robert Schwartz
Jonathan Schwartz
Original Assignee
Robert Schwartz
Jonathan Schwartz
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 Robert Schwartz, Jonathan Schwartz filed Critical Robert Schwartz
Publication of WO2023060187A1 publication Critical patent/WO2023060187A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00107Coatings on the energy applicator
    • A61B2018/00142Coatings on the energy applicator lubricating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1417Ball
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1465Deformable electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/0915Guide wires having features for changing the stiffness
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip

Definitions

  • Guidewires are commonly used medical devices that are used to assist in navigating catheters to a desired location in the body percutaneously. They are thin, flexible elements that are used in conjunction with steerable catheters. After a distal end of the guidewire is navigated to the target location, the catheter is retracted and removed, leaving the guidewire in place so that subsequent catheters may be tracked over the guidewire to the target location.
  • One aspect of the invention is to provide a longitudinal structure with a wire-like function that serves to deliver medical devices to various location within the body.
  • These longitudinal structures hereinafter referred to as “guidewires” whether or not they fit into conventional definitions of the term “guidewire,” may be used through various vessels, such as arteries, veins, lymphatics, to provide a few non-limiting examples, as well as via a direct percutaneous approach.
  • the guidewire embodiments may be of variable lengths, depending on the locations of the targeted anatomical structures being targeted.
  • One aspect of the invention provides a multi-segmented guidewire with numerous variable parameters that may be provided in any number of combinations depending on the needs of the procedures.
  • these parameters include: (1) thickness/diameter, (2) curves, (3) compliance/stiffhess, (4) modifiable baseline shapes.
  • the thickness or diameter may be constant or varying along the device length. Thickness and diameter can be important features of device specific application. In at least one embodiment, this parameter is customizable to create specific curvatures and compliance (stiffness) to enhance deliverability.
  • the curve parameter in at least one embodiment, provides specifically-placed device radii, having predetermined sizes and, in some embodiments, 3-dimensional shapes, that optimize, simplify, and/or shorten procedure times.
  • the compliance and thickness parameter in at least one embodiment, may be variable along the length of the guidewire, and may distributed in the form of segments of varying length.
  • the modifiable baseline shapes parameter may provide initial shapes, stiffness, compliance, curves and bends that are based on intended applications, including but not limited to the delivery of valves, stents, plugs, patches, electrodes, sensors, and various types of therapy such as injections and other delivery systems. These parameters may be modified by a user to create new directions, curves, and the like.
  • the device may be intended to fit specific applications that require alterations of one or more of the above embodiments, to optimize, shorten, and improve the safety of the procedures.
  • the guidewire may be preferentially and variably covered or coated with a lubricious material (such as hydrogel, for example) to assist and improve all features and specific performance parameters of device delivery.
  • a lubricious material such as hydrogel, for example
  • the guidewire may have one or more segments, or partial segments, that is/are coated or covered with a material that assists in gripping nearby anatomical or mechanical features or surfaces.
  • One aspect of the invention provides a multi-segmented guidewire that may have one or more electrical features such that the device may be used for pacing, stimulating, recording various characteristics of bodily tissues and structures, ablating and/or restructuring tissue in select areas.
  • the size, shape and location of the electrical features may be dictated by gaps in electrically insulative outer coatings on the guidewire.
  • individual insulated multifilar componentry may be used to transmit electricity and/or electrical signals, through an interior of the guidewire.
  • the electrical features may include one or more electrode along the course of the wire.
  • a guidewire equipped for monopolar pacing or recording may have a single electrode for monopolar pacing or recording.
  • 2 or more electrodes may be provided for bipolar or multipolar pacing, stimulating, ablating, or recording.
  • these electrical features may be integral to the guidewire. Additional components may be provided, such as metallic rings or other conducting nodes, to make positive electrical contact with surrounding tissue.
  • a metal backbone of the device may be used directly for stimulation, pacing, ablation, etc.
  • one or more embodiments of the device may use separate, integral cable connections internal to metallic pacing lead connections to facilitate electrical contact with tissue.
  • Both monofilar and multifilar construction can be considered for use in various segments to provide optimal stiffness and/or flexibility such as to prevent unwanted tissue penetration.
  • One aspect of the invention is a multi -segmented guidewire comprising: a flexible distal segment having an anti-perforation feature at a distal end thereof; a first mid-segment extending proximally from the distal segment, wherein the first mid-segment is stiffer than the distal segment; a second mid-segment, extending proximally from, and stiffer than, the first midsegment; and, a proximal segment that extends proximally from the second mid-segment, and having a connection hub at a proximal end of the proximal segment with a diameter larger than a diameter of the proximal segment.
  • FIG. 1 is a perspective view of an embodiment of a guidewire of the invention
  • FIG. 2 is a perspective view of an embodiment of a distal segment of the invention
  • FIG. 3 is a perspective view of an embodiment of a distal segment of the invention.
  • FIG. 4 is a perspective view of an embodiment of a distal segment of the invention.
  • FIG. 5 is a perspective view of an embodiment of a distal segment of the invention.
  • FIG. 6 is a perspective view of an embodiment of a distal segment of the invention.
  • FIG. 7 is a perspective view of an embodiment of a first mid-segment of the invention.
  • FIG. 8 is a perspective view of an embodiment of a second mid-segment of the invention.
  • FIG. 9 is a perspective view of an embodiment of a proximal segment of the invention.
  • Fig. 10 is a perspective view of an embodiment of a ring-shaped metallic section of the invention.
  • FIG. 11 is a perspective view of an embodiment of a connector of the invention.
  • Fig. 12 is a perspective view of an embodiment of a connector of the invention.
  • the multi-segmented guidewire 10 generally has a plurality of distinct segments.
  • the non-limiting example shown in Fig. 1 has four distinct segments: a distal segment 100, a first mid-segment 200, a second mid-segment 300, and a proximal segment 400.
  • a distal segment 100 a first mid-segment 200
  • a second mid-segment 300 a second mid-segment 300
  • a proximal segment 400 One skilled in the art will realize that a device could be constructed with fewer or more segments as needs dictate.
  • the lengths of each segment are also dictated by purpose and may vary based on target location for implant, patient size, etc.
  • Figs. 2-6 show various features that may be incorporated on distal segment 100. It is to be understood that the various features of the embodiments of the distal segment 100 may be shown separately in each figure for clarity but that these features may be present in varying combinations.
  • Fig. 2 shows a distal segment 100 having an anti -perforation feature 102.
  • the antiperforation feature 102 that includes an atraumatic ball 104 at the very distal tip 106 of the distal segment 100.
  • the atraumatic ball 104 may be formed by attaching a ball to the end of the distal segment 100, or by melting a small portion of the distal tip, such as with a laser or other heat source, to allow the surface tension of the liquified metal to form a sphere at the end.
  • Fig. 3 shows a distal segment 100 that includes a distal curl 108.
  • the distal curl 108 has a relatively tight radius so as not to interfere with navigation of the multi-segmented guidewire 10.
  • the distal curl 108 may optionally include the atraumatic ball 104, as shown.
  • Fig. 4 shows a distal segment 100 that includes a distal curl 108 in addition to two electrodes, a distal electrode 110 and a second electrode 112. Due to the distal curl 108, the distal electrode 110 may be connected to a more proximal location 114 on the distal segment 100 to form a loop 116. The second electrode 112, in combination with the distal electrode 110, creates a landing zone usable for pacing.
  • Fig. 5 shows a distal segment 100 in which the guidewire is formed into a distal spiral 120, as an example of an atraumatic shape.
  • Fig. 6 shows a distal segment 100 in which the guidewire is formed into a distal sphere 122, as an example of an atraumatic three-dimensional shape.
  • the guidewires having distal shapes such as those shown in Figs. 4-6 may be packaged and/or used in conjunction with an introducer sheath that keeps the distal segment 100 in a straight configuration until released in order to assist in loading the guidewire into a guidewire lumen of a delivery device (not shown).
  • the use of a memory metal such as nitinol ensures that the desired, heat set configuration will be assumed as soon as the distal segment is unsheathed.
  • Fig. 7 shows an embodiment of a first mid-segment 200, which extends proximally from the distal segment 100.
  • the first mid-segment may have stiffness characteristics that permit an arc 210 with a desired, relatively large, radius 212. If desired, the physician may alter the first mid-segment 200 manually to change the radius 212 to make the radius larger or smaller depending on need.
  • the first mid-segment 200 allows the very distal tip 106 with the anti-perforation feature 102 to bend and flex in three dimensions.
  • the first mid-segment 200 is a gently formed gradient of stiffness that increases from a proximal end 130 of the distal segment 100 toward, and in at least one embodiment, until a distal end of the second mid-segment 300. This gradient of stiffness, combined with the arc 210, assists in ensuring that the distal segment 100 conforms to a tissue wall such as a heart wall with minimal risk of perforation.
  • a larger radius 212 prevents the penetration of a chamber wall, or other tissue.
  • the arc 210 of the first mid-segment 200 conforms to the chamber wall, it uniquely provides firm support with little or no potential for injury to the wall. This reduced or eliminated chance of injury is due to the first midsegment 200 forces placed on the wall being distributed over a greater length of the first midsegment 200, if not the entire length of the first mid-segment 200. Distributing the forces that the first mid-segment 200 places on the wall over the length of the first mid-segment 200 diffuses the shearing wire force placed on the tissue as the wire is pushed over the tissue.
  • one or more pacing electrodes 230 are present. These pacing electrodes 230 may be provided independently or in addition to the electrodes 110 and 112 that may be present on the distal segment 100.
  • Fig. 8 shows an embodiment of a second mid-segment 300.
  • Second mid-segment 300 extends proximally from the first mid-segment 200 and serves to provide support and control when advancing a device toward a target location.
  • the second mid-segment 300 also functions to promote advancement in regions where resistance would otherwise inhibit smooth advancement of the device while conforming to a vascular or structural wall, such as across the aortic arch, like the first mid-segment 200.
  • the second mid-segment 300 is significantly stiffer than first mid-segment 200 and has a smaller radius 316.
  • second mid-segment 300 is capable of being manually reshaped by the operator as the operator sees fit. Custom shaping widens the scope of applications for the device.
  • the second mid-segment 300 is shown in Fig. 8 as optionally including one or more pacing electrodes in the form of electrically exposed surfaces 302.
  • These electrically exposed surfaces 302 may be created by strategically placed interruptions in an electrically insulative covering 304 over the second mid-segment 300.
  • a non-limiting example of strategic placement of the electrically exposed surfaces 302 may be placing the electrically exposed surfaces 302 on an outside surface 310 of a curve 312 to ensure contact between the electrically exposed surfaces 302 and a tissue wall.
  • the second mid-segment 300 may have a lubricious coating to facilitate easier, and less traumatic, pushing capabilities.
  • the exposed surfaces 302 may also be covered with a lubricious coating 314.
  • the lubricious coating 314 may be applied to the electrically insulative covering 304, or the electrically insulative covering 304 materials may be selected to have both insulative and lubricious properties. Additionally, the electrically exposed surfaces 302 may be coated with a lubricious coating 314.
  • the substance used for the lubricious coating 314 should be selected to be electrically conductive, or at least non-insulative, to avoid interfering with the electrical functions of the electrically exposed surfaces 302. If the electrically insulative covering 304 material has both insulative and lubricious properties, the electrically exposed surfaces 302 should be coated with a separate, lubricious and non-electrically interfering material, if it is deemed necessary to lubricate the electrically exposed surfaces 302.
  • Fig. 9 shows the proximal segment 400, which extends proximally from the second mid-segment 300.
  • the proximal segment 400 has a proximal end 402 and a distal end 404.
  • the proximal end 402 includes a connection hub 410 that is specifically shaped to allow secure grasping the wire using an elastic clamp. Examples of shapes included ridged, sphere, or other shapes having a larger diameter than the rest of the proximal segment 400.
  • the proximal segment 400 has a moderate stiffness that, in at least one embodiment, is more flexible than the second mid-segment 300 to provide an overall flexibility to the guidewire that facilitates easy navigation.
  • Figs. 10-11 show additional components that may also be featured in association with one or more segments of the multi-segmented guidewire 10.
  • Fig. 10 there are shown full or partial ring-shaped metallic sections 500 that serve as electrodes located within one or more of the segments of the multi-segmented guidewire 10.
  • These full or partial ring-shaped metallic sections 500 are used for pacing capabilities and may be configured for monopolar, bipolar, or multipolar pacing. Multifilar wires are usually insulated so the insulation would be removed to form these full or partial ring-shaped metallic sections 500.
  • these full or partial ringshaped metallic sections 500 may be used for transmitting biologic signals originating in the tissue wall out of the body.
  • the full or partial ring-shaped metallic sections 500 may also serve as an electrical connection hub for pacing, stimulation, recording, diagnostic data gathering, and ablation.
  • Fig. 11 shows an embodiment of a connector 600.
  • This connector 600 is usable for expeditiously connecting a pacemaker power supply to one or more of the full or partial ringshaped metallic sections 500, or one or more of the other electrodes (110, 112, 230, 302).
  • the connector 600 may include an indicator 602, such as an LED, that is used to signal that pacemaker integrity has been established.
  • the indicator 602 may flash when energized or it may be used to illuminate the multi-segmented guidewire 10 itself.
  • the connector 600 may serve to connect an external pacemaker to the wire electrodes.
  • This embodiment of connector 600 attaches to the multisegmented guidewire 10 at the proximal end 402 of the proximal segment 400, simply by pushing the connector 600 onto the end of the wire.
  • One side of the connector 600 may have a trumpeted shape 604 to assist pushing the multi-segmented guidewire 10 into the connector 600.
  • the trumpeted shape 604 tapers into a lumen 606 that continues to taper to a size slightly small than the wire diameter of the proximal end 402 of the proximal segment 400. This ensures a positive physical and electrical connection between the connector 600 and the proximal segment 400.
  • the connection hub 410 at the proximal end 402 of the proximal segment 400 may be shaped for use in conjunction with a connector 600 that has an expansion feature 610, as shown in Fig. 12. This connector embodiment provides tactile, and potentially audible, feedback with the connector 600 expands over the rim 420 and snaps back to a smaller diameter after passing over the rim 420.
  • This connector 600 may be removed by forcibly pulling the connector 600 back over the rim 420.
  • the expandable nature allows this removal to occur without damaging any components, and may connected, removed, and reconnected onto and off of the multi-segmented guidewire 10 numerous times during a procedure.
  • this connector 600 embodiment may be slid down the length of the multisegmented guidewire 10 such that the connector 600 is positioned mid-wire, such as over the pacing components of the full or partial ring-shaped metallic sections 500, in addition to being able to be placed at the proximal end 402. Due to the increased size of the connector 600, the connector 600 may also be used as a wire torquer, if needed, to push, pull or twist the multisegmented guidewire 10.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
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  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
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  • Molecular Biology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un fil-guide destiné à être utilisé dans l'administration de divers dispositifs et ayant une pluralité de segments distincts, chacun des segments ayant des buts et des caractéristiques différents tels que la rigidité, le diamètre, la courbure et des formes thermodurcies. Un ou plusieurs des segments peuvent également avoir une variété d'électrodes pour diverses utilisations telles que la stimulation, l'ablation et la collecte de données, pour en nommer quelques-unes.
PCT/US2022/077689 2021-10-06 2022-10-06 Fil-guide multi-segmenté WO2023060187A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163262175P 2021-10-06 2021-10-06
US63/262,175 2021-10-06

Publications (1)

Publication Number Publication Date
WO2023060187A1 true WO2023060187A1 (fr) 2023-04-13

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ID=85804758

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Application Number Title Priority Date Filing Date
PCT/US2022/077689 WO2023060187A1 (fr) 2021-10-06 2022-10-06 Fil-guide multi-segmenté

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4281660A (en) * 1978-10-18 1981-08-04 Tugumasa Fujiwara Method for fixing pervenous electrode in atrial pacing and device therefor
US5728148A (en) * 1995-11-08 1998-03-17 Pacesetter Ab Stylet unit for implanting a medical electrode cable
US20030083643A1 (en) * 2000-12-21 2003-05-01 Wilson W. Stan Guidewire with an intermediate variable stiffness section
US20060079787A1 (en) * 2004-09-30 2006-04-13 Whiting James S Transmembrane access systems and methods
US7998090B2 (en) * 2004-08-31 2011-08-16 Abbott Cardiovascular Systems Inc. Guide wire with core having welded wire segments
US20120130368A1 (en) * 2010-11-22 2012-05-24 Jenson Mark L Renal denervation catheter with cooled rf electrode
US20150314109A1 (en) * 2004-06-22 2015-11-05 Lake Regional Manufacturing, Inc. Variable stiffness guidewire

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4281660A (en) * 1978-10-18 1981-08-04 Tugumasa Fujiwara Method for fixing pervenous electrode in atrial pacing and device therefor
US5728148A (en) * 1995-11-08 1998-03-17 Pacesetter Ab Stylet unit for implanting a medical electrode cable
US20030083643A1 (en) * 2000-12-21 2003-05-01 Wilson W. Stan Guidewire with an intermediate variable stiffness section
US20150314109A1 (en) * 2004-06-22 2015-11-05 Lake Regional Manufacturing, Inc. Variable stiffness guidewire
US7998090B2 (en) * 2004-08-31 2011-08-16 Abbott Cardiovascular Systems Inc. Guide wire with core having welded wire segments
US20060079787A1 (en) * 2004-09-30 2006-04-13 Whiting James S Transmembrane access systems and methods
US20120130368A1 (en) * 2010-11-22 2012-05-24 Jenson Mark L Renal denervation catheter with cooled rf electrode

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