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WO2017180465A1 - Élimination de connexions électriques fixées au corps par croissance naturelle des tissus - Google Patents

Élimination de connexions électriques fixées au corps par croissance naturelle des tissus Download PDF

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Publication number
WO2017180465A1
WO2017180465A1 PCT/US2017/026566 US2017026566W WO2017180465A1 WO 2017180465 A1 WO2017180465 A1 WO 2017180465A1 US 2017026566 W US2017026566 W US 2017026566W WO 2017180465 A1 WO2017180465 A1 WO 2017180465A1
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WIPO (PCT)
Prior art keywords
lead
sheath
electrosurgical energy
energy
tip
Prior art date
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Ceased
Application number
PCT/US2017/026566
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English (en)
Inventor
John N. CATANZARO
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University of Florida Research Foundation Inc
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University of Florida Research Foundation Inc
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Publication date
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Publication of WO2017180465A1 publication Critical patent/WO2017180465A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/142—Electrodes having a specific shape at least partly surrounding the target, e.g. concave, curved or in the form of a cave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/0563—Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N2001/0578—Anchoring means; Means for fixing the head inside the heart having means for removal or extraction

Definitions

  • the disclosure relates to a system and method for extracting cardiac electrical leads, and in particular, applying electrical wave energy to loosen natural tissue growth to facilitate removal of leads.
  • a permanent pacemaker is an electronic device that provides an electrical signal to cause the heart to beat regularly when the internal signal of the heart is not functioning properly.
  • the PPM includes a power source, an electronic programmable pacemaking circuit, and one or more pacing leads which make contact with an internal or external surface of the heart.
  • a conductor at a tip of the wire forms the negative pole
  • a coil in the wire casing forms the positive pole
  • an inner coil forms the positive pole or cathode which extends beyond the casing to contact body tissue
  • the negative pole is another coil surrounding the cathode and stopping near the end of the wire, but at a distance, for example 12 mm from the end of the cathode.
  • ICD implantable cardioverter-defibrillator
  • a lead is typically placed at the apex or septum of the right ventricle, and another lead can be also be placed in the right atrium.
  • the atrium lead typically forms a J-shape, so that electrical contact is made near an upper surface of the atrium.
  • a third lead is placed on the outer wall of the left ventricle. Sensors are additionally provided on the leads for sensing electrical signals from the heart, which are used to determine timing or to generate other events.
  • PPM and ICD leads may become non-functional and need to be replaced. Problems can include inefficiency at delivering a required energy to the heart; too weak of a signal coming back from the heart, lead fracture, insulation failure, or infection. A lead must be removed when it becomes infected or is not working well enough.
  • a device for extracting a lead attached to body tissue by tissue growth comprises a sheath insertable into a lumen of the lead, the sheath forming a mesh that is at least one of expandable and contractable to at least one of compress to grip an outer surface of a wire of the lead and expand to contact a peripheral inner surface of the lumen, to engage the lead; and a connector for connecting a source of electrosurgical energy to the sheath.
  • the electrosurgical energy is radiofrequency energy; the electrosurgical energy is radiofrequency energy between 100 kHz and 1 MHz; the
  • electrosurgical energy is radiofrequency energy between 300 kHz and 500 kHz;
  • the sheath is electrically conductivethe device further includes a tip connected to a distal end of the sheath, the tip electrically connected to the connector, the tip operative to produce heat when the electrosurgical energy is applied to the connector;
  • the device further includes a tip connected to a distal end of the sheath, the tip electrically connected to the connector, the tip operative to radiate electrosurgical energy when electrosurgical energy is applied to the connector; and/or the sheath is configured to radiate electrosurgical energy along its length when electrosurgical energy is applied to the connector.
  • a method of extracting a lead attached to body tissue by tissue growth comprises inserting a sheath into a lumen of the lead, the sheath forming a mesh that is at least one of expandable and contractable to at least one of compress to grip an outer surface of a wire of the lead and expand to contact a peripheral inner surface of the lumen, to engage the lead; connecting a source of electrosurgical energy to the sheath; applying electrosurgical energy to the sheath through the connection to weaken the attachment between the tissue growth and the lead; and extracting the lead after weakening the connection.
  • the electrosurgical energy is radiofrequency energy
  • electrosurgical energy is radiofrequency energy between 100 kHz and 1 MHz;
  • electrosurgical energy is radiofrequency energy between 300 kHz and 500 kHz; and/or the attachment is weakened by at least one of heat and ablation.
  • a method for extracting a lead attached to body tissue by tissue growth comprises inserting a sheath into a lumen of the lead, the sheath forming a mesh that is at least one of expandable and contractable to at least one of compress to grip an outer surface of a wire of the lead and expand to contact a peripheral inner surface of the lumen, to engage the lead; connecting a source of electrosurgical energy to a wire within the lead; applying electrosurgical energy to the wire through the connection to weaken the attachment between the tissue growth and the lead; and extracting the lead after weakening the connection by applying traction to the sheath engaged with the lead.
  • the electrosurgical energy is radiofrequency energy; the electrosurgical energy is radiofrequency energy between 100 kHz and 1 MHz; the
  • electrosurgical energy is radiofrequency energy between 300 kHz and 500 kHz; the attachment is weakened by at least one of heat and ablation; the sheath is electrically conductive; and/or a tip is attached to a distal end of the sheath, the tip electrically connected to source of electrosurgical energy, the tip operative to produce heat when the electrosurgical energy is applied to the connector.
  • FIG. 1 depicts a PPM or ICD lead within the heart, and a method for attaching a source of electrosurgical energy to a wire of the lead while the lead is inside the heart, in accordance with the disclosure;
  • FIG. 2 depicts a lead locking stylet connected to a source of electrosurgical energy
  • FIG. 3 depicts a heat generating region of a sheath of the stylet of FIG. 2;
  • FIG. 4A depicts a stylet of the disclosure inserted within a blood vessel, surrounding a central wire, the stylet not fully engaged with the lead;
  • FIG. 4B depicts the stylet of FIG. 4 A, expanded to be engaged with the lead and a coil of the lead, and with electrosurgical energy applied to the sheath of the stylus to generate heat in the coil;
  • FIG. 5 depicts a unipolar stylet sheath and tip of the disclosure
  • FIG. 6 depicts a bipolar stylet sheath and tip of the disclosure
  • FIG. 7 depicts a cross-section of a stylet of the disclosure inserted into a lead lumen, and a source of electrosurgical energy applied to a wire of the lead to cause electrosurgical energy to produce heat in a tip of the lead in accordance with the disclosure;
  • FIG. 8 depicts electrosurgical energy applied to an inner coil and exposed distal helix in a cross-section of a lead, and a stylet lumen inserted within a lumen of the lead, in accordance with the disclosure;
  • FIG. 9 depicts leads attached by tissue growth to the body within the heart and vasculature;
  • FIG. 10A depicts two leads attached by tissue growth to myocardium of the right ventricle
  • FIG. 10B depicts separation of the two leads by application of electrosurgical energy in accordance with the disclosure
  • FIGS. 11 A-l ID depict PRIOR ART leads
  • FIGS. 12A-12C depict expansion and contraction of a sheath of the disclosure. DETAILED DESCRIPTION OF THE DISCLOSURE
  • Lead extraction can be performed using either the subclavian vein, or if access is difficult through that route, then a femoral vein can be used.
  • a femoral vein can be used.
  • an incision is made where the pacemaker or ICD device has been implanted. The device can be removed, or
  • the battery can be removed if the device is to remain. Leads are then
  • a hollow tube or sheath typically of plastic, is inserted over the lead, passed into the vein, and is guided along the lead to the lead tip which is attached to the myocardium by scar tissue or fibrous growth.
  • a laser or cutting sheath can be used to separate the lead from attachment to the vasculature or heart other than at the tip, along these techniques bring additional risk to the patient.
  • the sheath can contact body tissue at the tip, to hold the heart muscle in place while traction is applied to the lead.
  • the amount of traction is reduced due to the application of EE to the lead tip, to ablate or weaken with heat the tissue attaching the lead tip to the body.
  • radio frequency energy is directed to locations contacted by the lead, in order to disintegrate tissue or otherwise loosen the attachment between the lead and body tissue or vegetations, scar tissue, or fibrous material which is adhered to the lead.
  • the disclosure is applicable to PPM or ICD leads, and leads for any other electrical device used anywhere within the body, where the leads are in contact with body tissue for a period of time sufficient to form natural growths which attach the leads to the body.
  • a device and method are provided for lead extraction from the heart 300 and vasculature 308, particularly where lead explant would appear to require excess or potentially injurious force.
  • the lead 120 is prepared to have electrosurgical energy (EE) applied to it, in order to heat body tissue in contact with it.
  • EE electrosurgical energy
  • a mating connector end (not shown) is connected to the lead end, and a generator 200 of EE, for example radio frequency (RE) energy, is connected to the mating connector.
  • EE electrosurgical energy
  • a generator 200 of EE for example radio frequency (RE) energy
  • RE radio frequency
  • An example generator is the COVIDIEN FORCE FX, although numerous other types can be used, which are generally designed for cutting or coagulating body tissue using electrical energy, as is well understood within the art.
  • RF energy in the range of 100 kHz and 1 MHz, and advantageously between 350-500 kHz can be effectively used, but any frequency range which can cause ablation or sufficient heating of body tissue, and particularly scar tissue or fibrous material, can be used.
  • Power levels are selected to be just sufficient to cause weakening of the fibrous connection to the lead, to avoid damage to adjacent tissues.
  • Sensors can be used to monitor heat at the localized region of application of EE energy in accordance with the disclosure, whereby power levels can be reduced if heating becomes excessive. While lower frequency AC or pulses of DC can be used as EE, these have been found to have the disadvantage of stimulating nerves which can cause pain, while RF frequencies have been found to largely avoid this problem.
  • RF can be controlled to have a local effect, penetrating body tissue to a limited depth, thereby reducing damage to nearby tissue.
  • the lead may be more expedient to simply strip the cut lead end, particularly as a mating connector end may not be readily available. Accordingly, the lead is disconnected from the PPM or ICD (not shown), and any connectors are removed. The lead end is then stripped of insulation, exposing a sufficient amount of the central wire 122, typically a cathode, to enable an electrical connection to be made to wire 122. In the embodiment shown, an alligator clip 220 is used, although any other suitable form of electrical connection can be made.
  • EE can be applied to the coil in addition to, or alternatively to, central wire 122. More particularly, adhesions can be connected to the coil, and while an Excimer laser may be able to remove such adhesions, not all facilities are equipped with such a device. Moreover, if the device of the disclosure is to be used, it can address vascular adhesions and other adhesions along the wire as well as adhesions on the distal tip of lead 120 at the myocardium, thereby requiring less equipment in the operating theatre, and reducing costs.
  • a grounding electrode is placed on the patient, and is connected to generator 200.
  • EE is applied to wire 122, heating occurs at the wire tip, for example at an embedded wire helix, where a conductive path has been formed to the grounding electrode through the adhesion. This weakens the connection of the adhesion to the wire, enabling a reduced force to be applied to the wire in order to extract the lead. Additional details can be found in
  • a locking stylet 170 is inserted into a lumen 124 of the wire, for example interior to conduction coil 130, or within an outer sheath 126 of lead 120. More particularly, an expandable braided stylet sheath 172 is inserted within lead 120 to extend as close as possible to a distal end of lead 120.
  • Sheath 172 is formed of electrically conductive metal, for example NITINOL or other shape memory metal, stainless steel, or other conductive metal or material, and accordingly, EE can be applied to sheath 172 to cause the release of EE near to the distal end of lead 120, where it may act upon the fibrosis to weaken the connection between lead 120 and body tissue.
  • electrically conductive metal for example NITINOL or other shape memory metal, stainless steel, or other conductive metal or material
  • sheath 172 is passed within an outer sheath 126 or other lumen 124 of lead 120, over wire 122, as shown in FIG. 12 A.
  • Sheath 172 can be contracted, for example by being stretched, to thereby compress and grip wire 122 within the lumen. In this manner, sheath 126 provides stability to wire 122 to prevent the wire 122 from breaking during extraction, particularly during extraction using tension.
  • sheath 172 can be expanded to grip an inner wall of sheath 126, whereby sheath 172 can be pulled to remove lead 120 while simultaneously providing stability to lead 120.
  • sheath 126 can include a tensioning rod 184 which passes from a distal end of the sheath to the proximal end. Pulling on sheath 172 (arrow “A" of FIG. 12B) causes contraction of sheath 172, while pushing on sheath 126 (arrow “B” of FIG. 12C) relative to the tensioning wire produces expansion of sheath 172. Alternatively, pushing or maintaining an orientation of the tensioning rod 184 while.
  • tensioning rod 184 can avoid stressing parts of the lead 120 during expansion or contraction, thereby avoiding break lead 120, which could lead to complications. It should be understood that tensioning rod 184 can have the form of a sleeve or coil, for example, or other elongate structure which has a limited deformability in the axial direction relative to sheath 172.
  • sheath 172 may not extend outside the body when style 170 is deployed, and accordingly, one or two wires can be routed through stylet 170 to electrically connect to sheath 172.
  • FIG. 2 illustrates, by a dashed line, an electrical connection to a grounding electrode 174, which is used for a unipolar configuration of the disclosure. In this event, a single wire is routed through stylet 170 to connect to sheath 172.
  • a bipolar configuration of the disclosure is described in greater detail elsewhere herein.
  • stylets 170 There are a variety of types of stylets 170, and the illustrations are representative.
  • the illustrations generally correspond to a COOK MEDICAL LIBERATOR, or a SPECTRANETICS LLD (Lead Locking Device) type stylet, which expand within a lumen 124 of lead 120, passing over or alongside an innermost wire.
  • SPECTRANETICS LLD Lead Locking Device
  • a COOK MEDICAL BULLDOG type device can be used, in which a loop and mesh is passed over the outside of lead 120, and which compresses against the outside of lead 120, for instances in which lead 120 is damaged or does not include an inner lumen of sufficient width.
  • the Bulldog device would tend to produce heat along its length as it makes contact with body tissue; however, portions can be insulated from contact with the body, thereby releasing EE at the uninsulated regions.
  • FIG. 3 illustrates an enlarged view of a stylet mesh sheath 172, illustrating a zone of heating occurring most proximate contact with body tissue at a distal end 176.
  • FIGS. 3 and 4 illustrate the functioning of the stylet sheath 172 which has been passed over the inner wire in FIG. 4 A, and which has been expanded against an inner coil 130 in FIG. 4B. If inner coil 130 is not insulated and contacts an inner wall 306 of the vasculature 308, as illustrated in FIGS. 4A-B, heating will occur along the length of the inner coil 130, as illustrated, including the area of fibrotic adhesion 310.
  • FIGS. 5-8 illustrate various possible forms of lead extractors 170 of the disclosure which can be used to apply EE to loosen or release a wire 120 which has been attached to the body by overgrowth.
  • a single insulated EE conducting lead 178 is passed through the interior of sheath 172, to an insulating connector 180.
  • Lead 178 can pass through connector 182, or can be connected to a conductor passing through insulating connector 182.
  • a heater tip 182 which is heated by forming a connection between the EE signal delivered by lead 178 and a ground applied to an exterior of the body.
  • a ground is applied within the body, for example by piercing the body to place a conductive electrode tip close to or at an area of adhesion.
  • a bipolar configuration of stylet 170 includes two wires 178 and 186, wherein each pass a signal through insulating connector 180, and is connected to tip 182 to cause local heating or release of EE energy, only near the tip of lead 120.
  • Tip 182 can be configured as a heater or a transmitter of EE.
  • a stylet 170 of the disclosure is inserted within a lumen 124 of wire 120, and EE is applied to wire 122, which is connected to tip 182'.
  • a ground path can be formed through an electrode placed on the patient.
  • coil 130 is connected to tip 182' during manufacturing to form a lead of the disclosure, and is insulated from wire 122, whereby a ground signal can be applied to coil 130 to cause heating or transmission of EE at tip 182' by forming a path within tip 182' to wire 122.
  • a separate electrical pathway is manufactured together with the lead of any configuration, to conduct EE as described herein, thereby forming a lead of the disclosure that is readily adapted for the application of EE to aid in releasing adhered leads.
  • stylet sheath 172 surrounds an inner coil 128, and secures against in inner wall of lumen 124. Traction can be applied to sheath 172 as EE energy is transmitted through inner coil 128, which forms a helix at a distal end that is implanted into body tissue. A ground signal applied to the body causes application of EE at the region of implantation to loosen an attachment between body tissue and helix 132.
  • FIG. 9 illustrates a typical application of a stylet or lead of the disclosure, wherein the superior vena cava 314 includes fibrous material 312 attaching two leads 120 to an inner wall of the venous lumen. Fibrous material 316 adheres an end of a J-shape 320 formed in wire 120 A, which forms a contact near an A-V node of the right atrium 318. In the right ventricle 330, a fibrosis attaches a distal end of lead 120 near Purkinje fibers. While not illustrated, there can be additional leads, particularly for an ICD, and there can be leads within the left side of the heart, as well.
  • FIGS. 10 and 10A illustrate a fibrosis that has formed in the ventricle at two locations 324, 326. In FIG. 10A, EE has been applied to separate the wire from the fibrous material, whereby the lead may be extracted.
  • FIGS. 11 A-l ID depict various prior art forms of ICD or PPM leads each having one or more lumens 114 into which a stylet sheath 172 can be inserted.
  • sheath 172 can be passed into an interior space formed by a tip electrode coil 132.
  • either inner pacing coil/helix 132 or inserted sheath 172 can conduct EE.
  • outer coil 130 which may be a shocking coil, can conduct EE and can form an EE radiator, to cause heating along the length of lead 110.
  • FIG. 11C illustrates a lead design having sensing and pacing conductors 140, 110, and a non- concentrically disposed high voltage defibrillation coil 142, which forms a lumen 114 into which sheath 172 can be inserted. Either or both of coil 142 or sheath 172 can apply EE as described herein.
  • FIG. 11C illustrates a lead design having sensing and pacing conductors 140, 110, and a non- concentrically disposed high voltage defibrillation coil 142, which forms a lumen 114 into which sheath 172 can be inserted. Either or both of coil 142 or sheath 172 can apply EE as described herein.
  • FIG. 11C illustrates a lead design having sensing and pacing conductors 140, 110, and a non- concentrically disposed high voltage defibrillation coil 142, which forms a lumen 114 into which sheath 172 can be inserted. Either or both of coil
  • 1 ID depicts a lead 110 design in which several lumens 114 are available for sheath 172 insertion, and several conducts are available for introduction of EE.
  • a conductor can be selected based upon the conductor having an electrically exposed are which is proximate a fibrous connection, to thereby direct EE to adhesions or connections to body tissue which prevent extraction of lead 110.
  • a fluid having a predetermined conductivity can be directed to a location where EE is applied to control impedance to either increase or decrease conductivity at the site, or to cool adjacent tissue which it is desired to protect.
  • One or more sensors can be used to monitor heat at the location where EE is directed, to determine if the total heat generated is within a predetermined range of efficacy regarding releasing lead 120, and safety for surrounding tissue.

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Abstract

La présente invention concerne des connexions thérapeutiques cardiaques pouvant se fixer au tissu corporel par croissance des tissus, les rendant difficiles à retirer sans blesser le patient ni briser la connexion, qui peut résulter en portions de la connexion restant à l'intérieur du patient. Une gaine maillée est insérée dans une lumière de la connexion. La maille est contractible ou expansible pour soit comprimer afin de saisir une surface externe d'un fil de la connexion, soit s'expanser pour entrer en contact avec une surface interne périphérique de la lumière. De cette manière, la gaine vient en prise avec la connexion et fournit une stabilité afin de maintenir la connexion intacte durant l'élimination. Une source d'énergie électrique peut être appliquée à la gaine pour desserrer la fixation de tissu, facilitant ainsi l'élimination de la connexion sans dommage.
PCT/US2017/026566 2016-04-15 2017-04-07 Élimination de connexions électriques fixées au corps par croissance naturelle des tissus Ceased WO2017180465A1 (fr)

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US6033402A (en) * 1998-09-28 2000-03-07 Irvine Biomedical, Inc. Ablation device for lead extraction and methods thereof
US6183469B1 (en) * 1997-08-27 2001-02-06 Arthrocare Corporation Electrosurgical systems and methods for the removal of pacemaker leads
US20130178841A1 (en) * 2012-01-05 2013-07-11 Vivant Medical, Inc. Ablation Systems, Probes, and Methods for Reducing Radiation from an Ablation Probe into the Environment
US8668687B2 (en) * 2010-07-29 2014-03-11 Covidien Lp System and method for removing medical implants
US8808281B2 (en) * 2008-10-21 2014-08-19 Microcube, Llc Microwave treatment devices and methods
US9301773B2 (en) * 2009-01-13 2016-04-05 Leadex Cardiac Ltd. Lead extraction methods and apparatus

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5207683A (en) * 1988-11-09 1993-05-04 Cook Pacemaker Corporation Apparatus for removing an elongated structure implanted in biological tissue
US6183469B1 (en) * 1997-08-27 2001-02-06 Arthrocare Corporation Electrosurgical systems and methods for the removal of pacemaker leads
US6033402A (en) * 1998-09-28 2000-03-07 Irvine Biomedical, Inc. Ablation device for lead extraction and methods thereof
US8808281B2 (en) * 2008-10-21 2014-08-19 Microcube, Llc Microwave treatment devices and methods
US9301773B2 (en) * 2009-01-13 2016-04-05 Leadex Cardiac Ltd. Lead extraction methods and apparatus
US8668687B2 (en) * 2010-07-29 2014-03-11 Covidien Lp System and method for removing medical implants
US20130178841A1 (en) * 2012-01-05 2013-07-11 Vivant Medical, Inc. Ablation Systems, Probes, and Methods for Reducing Radiation from an Ablation Probe into the Environment

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