WO2008057651A1 - Cardiac lead with a retractable helix - Google Patents

Cardiac lead with a retractable helix Download PDF

Info

Publication number
WO2008057651A1
WO2008057651A1 PCT/US2007/077528 US2007077528W WO2008057651A1 WO 2008057651 A1 WO2008057651 A1 WO 2008057651A1 US 2007077528 W US2007077528 W US 2007077528W WO 2008057651 A1 WO2008057651 A1 WO 2008057651A1
Authority
WO
WIPO (PCT)
Prior art keywords
lead
distal
fixation helix
management system
electrode
Prior art date
Application number
PCT/US2007/077528
Other languages
French (fr)
Inventor
Jeffrey P. Bodner
Walter C. Laroche
Original Assignee
Cardiac Pacemakers, Inc.
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 Cardiac Pacemakers, Inc. filed Critical Cardiac Pacemakers, Inc.
Priority to JP2009535373A priority Critical patent/JP2010508904A/en
Priority to EP07841821A priority patent/EP2079509A1/en
Publication of WO2008057651A1 publication Critical patent/WO2008057651A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • A61N1/0575Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook with drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N2001/0578Anchoring means; Means for fixing the head inside the heart having means for removal or extraction

Definitions

  • the present invention relates to the field of medical leads. More specifically, the present invention is directed to a medical electrical lead having an extendable and retractable helix for securing the distal end of the cardiac lead within a cardiac chamber.
  • Implantable medical devices for treating irregular contractions of the heart with electrical stimuli are well known.
  • Exemplary implantable devices are defibrillators and pacemakers.
  • Various types of electrical leads for defibrillators and pacemakers have been suggested, many of which are placed transvenously. Such leads are introduced into the patient's vasculature at a venous access site and travel through veins to the sites where the leads' electrodes will be implanted or otherwise contact target coronary tissue.
  • Electrodes for transvenously-placed leads can be implanted in the myocardium of the right atrium or ventricle, or alternatively, another location within the coronary venous system.
  • fixation techniques should provide fixation stable enough to withstand natural heart motion and retrograde blood flow which tend to push the lead out of the location into which the electrode is implanted. Additionally, it is desirable to permit and facilitate repositioning or removal of the lead and fixation structures after implantation if necessary or desired.
  • Helixes for fixing leads are known in the art. It is also recognized that the larger the helix is in diameter, the more stable fixation it provides. In a typical lead configuration, a fixation helix is extended and retracted from a position located internally within the lead body or catheter. As such, the size of the fixation helix used to secure lead bodies is limited by the diameter of the lead body or catheter. The size and type of electrode that is placed within the lead is also limited by this configuration.
  • the present invention is a cardiac rhythm management system including a pulse generator adapted to deliver a therapy to a patient's heart, and an electrical lead, including an electrical lead body and proximal and distal portions.
  • the proximal portion is operatively coupled to the pulse generator and the distal portion is disposed in a heart chamber.
  • the cardiac rhythm management assembly also includes at least one electrode located at the distal end of the electrical lead and a fixation helix adapted to extend from a first position disposed over the distal portion of the electrical lead including the electrode to a second position located distally to the distal end of the electrical lead.
  • a cardiac rhythm management system includes a pulse generator adapted to deliver a therapy to a patient's heart; an electrical lead including a proximal portion and a distal portion, the proximal portion operatively coupled to the pulse generator and the distal portion disposed in a chamber of the heart; a fixation helix having a proximal end and a distal end, the fixation helix coupled to the electrical lead; and at least one electrode located at a distal end of the electrical lead.
  • the electrode is disposed within the fixation helix and adapted to move from a distal position to a proximal position located within the fixation helix.
  • a lead for placement at a site located within a chamber of a heart includes an electrical lead body; a proximal portion; a distal portion; at least one electrode; and a fixation means disposed over the electrode for securing the distal end of the lead in the heart chamber.
  • a cardiac rhythm management system includes: a pulse generator adapted to deliver a therapy to a patient's heart; an electrical lead having a lead body and a proximal portion and a distal portion, the distal portion disposed in a chamber of the heart; at least one electrode located at a distal end of the electrical lead; and a fixation helix disposed over the distal portion of the lead including the electrode.
  • the fixation helix is configured so as not to snag tissue during insertion of the lead into a patient's vasculature.
  • FIG. 1 is a perspective view of a pulse generator coupled to a lead deployed in a patient's heart according to one embodiment of the present invention.
  • FIG. 2A is a side plan view and FIG. 2B is a sectional view of a distal portion of the lead shown in FIG. 1. As shown in FIG. 1 , a fixation helix is retracted over the distal end the lead.
  • FIG. 2C is side plan view and FIG. 2D is a sectional view of the distal portion illustrated in FIG. 1. As shown, the fixation helix extends over the distal end of the lead.
  • FIG. 3 is a perspective view of the fixation helix of the present invention.
  • FIG. 4 is a sectional view of a stylet engaging a distal portion of a lead shown in FIGS. 2A-2D according to an embodiment of the present invention.
  • FIG. 5A is a side plan view and FIG. 5B is a sectional view of a distal portion of a lead shown in FIG. 1 according to an embodiment of the present invention.
  • FIG. 5C is a side plan view of the distal portion illustrated in FIG.
  • fixation helix extends over the distal portion of the lead.
  • FIG. 6 is a sectional view of a stylet engaging a distal portion of a lead shown in FIGS. 5A-5C according to an embodiment of the present invention.
  • FIGS. 7A and 7B show a sectional view of a distal portion of a lead shown in FIG. 1 according to an embodiment of the present invention.
  • FIG. 1 shows a cardiac rhythm management system 4 in accordance with the present invention.
  • the cardiac rhythm management system 4 includes a pulse generator 6 coupled to an electrical lead 8 deployed in a patient's heart 10 through a superior vena cava 12.
  • the heart 10 includes a superior vena cava 12, a right atrium 14, a right ventricle 16 having an apex 17, a ventricular septum 18, a ventricular outflow tract 20, which leads to a pulmonary artery 22 having a pulmonary valve 24, a left ventricle 26, and a left atrium 28.
  • the lead 8 is adapted to deliver an electrical pulse, such as a pacing pulse or defibrillation, to the heart 10 via an electrode 36 positioned in the right ventricle 16 near the right ventricular apex 17.
  • the lead 8 includes an elongate, flexible lead body 40 and a proximal portion 42 and a distal portion 44.
  • the lead 8 also includes one or more conductors, such as a coiled conductor, for conducting energy from the pulse generator 6 to the heart 10, and also to receive signals from the heart 10. Additionally, the lead 8 may have a co-radial design.
  • the lead 8 further includes outer insulation 45 to insulate the conductor.
  • the conductor or conductors are coupled to one or more electrodes, such as electrode 36.
  • the lead 8 includes a lumen for receiving a guiding element such as a guide wire or a stylet.
  • the proximal portion 42 is operatively coupled to the pulse generator 6. Additionally, the proximal portion 42 is operable to manipulate the distal portion 44 of the lead 8 through the vasculature to position the distal end 46 of the lead 8 including the electrode 36 into a target location within a heart chamber using techniques well known in the art. It is appreciated that the lead 8 can be deployed to alternate locations within the heart such as the left side of the heart as is known in the art (e.g. the left ventricle).
  • the distal portion 44 is guided through the superior vena cava 12 and the right atrium 14 to a target position located near the right ventricular apex 17 of the heart 10.
  • the distal portion 44 of the lead 8 includes at least one electrode 36 at the distal end 46 of the lead body 40.
  • the distal end 46 of the lead 8 is secured to the myocardium using a fixation device.
  • the fixation device is a fixation helix that extends and retracts over a distal portion 44 of the lead body 40 including the electrode 36 located at a distal end 46 of the lead 8.
  • FIGS. 2A-2D show multiple views of the distal portion 44 of the lead 8 in accordance with the present invention.
  • the distal portion 44 of the lead 8 includes a distal end region 60 including a distal assembly 71, a distal sheath 75, an electrode 80, and a fixation helix 82.
  • the electrode 80 is located within the distal sheath 75 and includes an electrode tip 84.
  • the fixation helix 82 is coupled to the distal assembly 71 , and is disposed over the distal sheath 75 and the electrode 80.
  • the fixation helix 82 is rotatably disposed over the sheath 75.
  • the electrode 80 is disposed within the distal sheath 75 and is located at a distal end 46 of the lead body 40.
  • the electrode 80 is in electrical communication with the distal end 46 of the lead 8 through a conductor 86 deposited axially along an inner surface of the distal sheath 75.
  • the conductor 86 communicates with the conductor coil in the lead body 40 through a secondary conductor coil 87 located in the distal portion 44 of the lead 8.
  • the outer surface of the distal sheath 75 is coated with a nonconductive material such as is known in the art (e.g. paralyene). This prevents electrical noise or "chatter" from interfering with the electrical pulse produced by the electrode 80.
  • the electrode 80 can have any configuration as is known in the art. According to one embodiment, the electrode 80 has a generally hemi-spherical configuration. According to another embodiment, the electrode 80 is a slotted tip electrode and includes an electrode tip 84 and a reservoir 88. The reservoir 88 is adapted to hold and deliver a drug to the myocardial tissue at a target location within the heart 10. In one embodiment of the present invention, the drug is a steroid for reducing inflammation at the target location. Alternatively, the drug can be any other drug or therapeutic agent known in the art for delivering therapy to a patient's heart 10. Furthermore, it is appreciated that other medical devices such as sensors and the like can be adapted to be positioned and secured using the features of the present invention.
  • the distal assembly 71 includes a distal shaft 92, a distal assembly housing 93, and a rotatable pin 94.
  • the pin 94 travels in a groove 96 (best viewed in FIGS. 2A and 2C) located in the distal sheath 75.
  • the groove 96 includes stop regions 98 and 99, and controls the advancement and rotation of the fixation helix 82. Actuation of the pin 94 within the distal assembly 71 rotates the fixation helix 82 over the distal sheath 75 and electrode 80 in a proximal or distal direction.
  • the fixation helix 82 includes a proximal end 102, a distal end 104, and a tip 106. According to an embodiment of the present invention, the fixation helix 82 rotatably extends and retracts independently of the electrode 80 disposed within the distal sheath 75. The fixation helix 82 extends and retracts from a retracted position 108 (shown in FIG. 2A) to an extended position 110 (shown in FIG.
  • the groove 96 located in the distal sheath 75 controls the advancement of the fixation helix by providing stop regions 98 and 99 for both the extension and retraction of the helix.
  • the stop region 99 prevents the fixation helix from being extended too far beyond its intended extended position 110.
  • the stop region 98 prevents the fixation helix from being retracted too far over the distal sheath 75.
  • the fixation helix 82 allows the fixation helix 82 to be extended and retracted in a controlled manner.
  • the extended position 110 is located distally to the distal end 46 of the lead 8.
  • the extended position 110 is located distally to the electrode tip 84.
  • the fixation helix 82 is capable of extending a distance from about 1.5 mm to about 2 mm as measured from the electrode tip 84.
  • the distal end 104 of the fixation helix 82 is radially aligned with the electrode tip 84.
  • the fixation helix 82 is in the retracted position 108 when the lead 8 is guided through the vasculature and positioned at the target site.
  • the tip 106 will not snag on the vascular tissue as the lead 8 is guided through the vasculature.
  • the tip 106 is ground such that it deflects inward towards an interior of the helix 82. It is this configuration that allows the tip 106 not to snag on the vascular tissue as the lead 8 is guided through a patient's vasculature system.
  • the tip 106 includes one facet.
  • the tip 106 of the helix 82 may include two or more facets for engaging the myocardial tissue at the target location.
  • the tip 106 shape may be configured to be pyramidal, conical, blunt, rounded, or another shape as known in the art.
  • the outer diameter of the fixation helix 82 ranges from about 0.045 inches to about 0.092 inches. In another embodiment of the present invention, the outer diameter of the fixation helix 82 ranges from about 0.045 to about 0.050 inches. In yet another embodiment, the outer diameter of the fixation helix ranges from about 0.050 to about 0.079 inches.
  • FIG. 3 shows the fixation helix 82 according to an embodiment of the present invention.
  • the helix 82 includes a proximal end 102, a distal end 104, and a helix body 110 extending there between. Located at the distal end 104 is the helix tip 106.
  • the material for forming the helix includes, but is not limited to, the following: Nitinol, NiTi alloy, titanium, spring temper 316 SS, MP35N, platinum or platinum alloy, polyurethane, bio-compatible polymers or another material as is known in the art.
  • the helix is a wire coil including a non-conductive outer coating.
  • the non-conductive coating coats 100% of the wire helix and ranges from about 4 to about 5 microinches thick.
  • the coil itself is nonconductive.
  • the turns 107 of the helix 82 maintain a constant pitch (frequency) over a specified length of the helix body 110. In the present invention the pitch ranges from about 0.030 to about 0.050 inches.
  • a proximal end 102 of the helix 82 includes a minimum of two full turns having a more tightly wound pitch than the specified length of the helix body 110. There is a smooth transition from the tightly wound proximal end 102 of the helix 82 to the helix body 110 having a constant pitch.
  • the helix tip 106 When the helix 82 is in the second position 110, the helix tip 106 is capable of engaging the myocardial tissue at the target location.
  • the helix 82 rotatably engages the myocardial tissue at the target location through the actuation of the distal assembly 71 located within the distal portion 60 of the lead 8, as shown in FIGS. 2A-2D.
  • the helix tip 106 is rotated into the myocardial tissue until it is secured and stabilized in the target location.
  • a stylet 114 is inserted into a lumen 116 provided in the lead 8.
  • the stylet 114 is used to actuate the distal assembly 71 provided at the distal end region 60 of the lead 8.
  • the stylet 114 includes a distal end 118 and is operated at the proximal portion 42 of the lead 8.
  • the distal end 118 of the stylet 114 is adapted to rotatably engage a slot 120 located on the distal shaft 92 and adapted to rotatably receive the distal end 118 of the stylet 114.
  • the stylet 114 When the stylet 114 is engaged in the slot 120 located on the distal shaft 92, the stylet 114 is used to rotate the distal assembly 71 thus rotating the fixation helix 82.
  • Pushing and rotating the distal shaft 92 in a distal direction causes the pin 94 to travel through the groove 96 located in the distal sheath 75 extending the helix 82 from a retracted position 108 located over the distal portion 44 of the lead body 40 including the electrode 80 to an extended position 110 located distally the distal end 46 of the lead body 40.
  • the helix 82 can be further rotated to engage the myocardial tissue at the target location.
  • the stylet 114 is operated in the opposite direction to disengage the helix from the myocardial tissue and to retract the helix from the extended position 110 to its retracted position 108.
  • the lead 8 can then be either repositioned or retrieved.
  • the lead 8 includes a distal portion 200 including a distal assembly 210, a distal sheath 215, an electrode 220 including an electrode tip 221 , and a fixation helix 225.
  • the distal portion 200 also includes a spring 227 (shown in FIG. 2B).
  • the fixation helix 225 couples with the distal assembly 210 and is disposed over the distal sheath 215 including the electrode 220.
  • the distal assembly 210 includes a distal shaft 232, a locking pin 234, and a slot 240 provided in the distal sheath 215.
  • the locking pin 234 is slideably engaged in the slot 240.
  • the slot 240 is a J-shaped slot.
  • the slot 240 can have any appropriate shape as is known in the art for slideably engaging and locking a pin 234.
  • the locking pin 234 slides from a proximal position 246 in the J-shaped slot 240 to a distal position 248 located in the end portion of the J-shaped slot 240.
  • the spring 227 places a tension or distal force on the pin 234 as the pin 234 moves from a proximal position 246 to a distal position 248.
  • FIG. 6 is a sectional view of a stylet engaging a distal portion of a lead as shown in FIGS. 5A-5C. According to one embodiment of the present invention, as shown in FIG.
  • the distal shaft 232 includes a slot 235 sized to rotatably receive a flat portion of a stylet for manipulating the locking pin 234 in the J-shaped slot 240.
  • a stylet 250 is inserted into a lumen provided in the lead 8.
  • the stylet 250 includes a distal end 262 adapted to rotatably engage the slot 235 located on the distal shaft 232 of the distal assembly 210.
  • a physician uses the stylet 250 to push on the locking pin 234 causing the locking pin 234 to slide from a proximal position 246 to a distal position 248 in the J- shaped slot 240 provided in a distal sheath 215. As this process occurs, the fixation helix 225 extends from a retracted position to an
  • the fixation helix 225 extends from a retracted position to an extended position located distally to the electrode tip 221.
  • the stylet 250 is then used to lock or secure the fixation helix 225 in place by positioning the locking pin 234 in the curved portion of the J-shaped slot 240.
  • the lead body 40 using techniques well known in the art, is then rotated in a first direction to engage and secure the fixation helix 225 in the myocardial tissue at the target site in a patient's heart. [037] To release the helix, the operations are reversed.
  • the lead body 40 is rotated in a second, opposite direction to disengage the fixation helix 225 from the myocardial tissue at the target location. Then, the physician pushes forward on the stylet 250 to release the locking pin 234 from the curved portion of the J-shaped slot 240. The locking pin 234 is allowed to slide from a distal position 248 back to a proximal position 246. The lead 8 then can be repositioned at the target location or removed.
  • the distal portion 300 of a lead 8 includes a distal assembly 306 including a distal sheath 310, an electrode 315 disposed within the distal sheath 310, and a fixation helix 320. Additionally, the electrode 315 is coupled to a drive shaft 318 located within the distal sheath 310.
  • the drive shaft 318 includes threads 321 on an outer portion 322 of the shaft 318 and is threadably engaged with threads 324 disposed on an inner portion 325 of the distal sheath 310.
  • the fixation helix 320 extends over a distal end 326 of the lead body 40 to a point distal to an electrode tip 328.
  • the fixation helix 320 is stationary with respect to the distal sheath 310.
  • the distal position 330 of the electrode tip 328 within the fixation 320 prevents the fixation helix 320 from snagging on any myocardial tissue during the insertion and deployment of the lead 8.
  • the lead body 40 is rotated using techniques well known in the art to secure and stabilize the fixation helix 320 in the myocardial tissue at the target location in a patient's heart.
  • the electrode 315 is moved within the fixation helix 320 from a distal position 330 located distally to a distal end 46 of the lead 8 to a proximal position 332.
  • the electrode tip 328 in the distal position 330, is in close proximity to the myocardial tissue. In another embodiment of the present invention, the electrode tip 328 contacts the myocardial tissue at the target location.
  • the electrode position can be selected and adjusted as necessary.
  • the lead 8 includes a terminal drive mechanism 350 having an inner coil 352 extending the length of the lead body 40.
  • the inner coil 352 includes a terminal end 354 adapted to rotatably engage a recess 356 provided on the drive shaft 318 located within the distal sheath 310.
  • a fixation tool 358 is provided at the proximal end 42 of the lead body 40.
  • the fixation tool 358 is adapted to rotatably engage a proximal end 360 of the inner coil 352.
  • the fixation tool 358 is used to actuate the terminal drive mechanism 350 by rotating the inner coil 352 to engage and rotate the drive shaft 318 located within the distal sheath 310.
  • Rotation of the drive shaft 318 in a first direction moves the electrode 315 from a distal position 330 to a proximal position 332.
  • the electrode 315 when the electrode 315 is in the distal position 330, the electrode 315 is in close proximity to the myocardial tissue at the target location. In alternate embodiments, the electrode 315 can contact the myocardial tissue at the target location.
  • the lead body 40 is rotated to disengage the fixation helix 320 from the myocardial tissue at the target location. The lead 8 can then either be repositioned or removed.
  • a lead including a distal portion having a fixation helix described according to the various embodiments discussed above can be deployed in a patient's heart using standard techniques known to those of skill in the art. As the helix is designed not to snag on cardiac tissue
  • a guide catheter or protective outer sheath is not required. This allows flexibility in determining lead and fixation helix diameter. For example, a small diameter lead may be selected having a large fixation helix disposed over an outer surface of a distal portion of the lead, optimizing fixation stability of the lead at the target location.
  • the fixation helix allows the lead to be repositioned or removed from its target location within a patient's heart. If a clinician desires to reposition the lead, the fixation helix may be retracted from the extended position to the retracted position allowing the lead to be repositioned. The fixation helix can then be used again to secure the lead at the target location. Alternatively, the fixation helix can be retracted and the lead removed. According to another embodiment of the present invention, the fixation helix is capable of substantially permanent deployment to the target location to prevent the lead from becoming dislodged or repositioned during use.

Abstract

A cardiac rhythm management system for securing a cardiac lead within a patient's heart is provided. According to the present invention, the cardiac rhythm management system includes a fixation helix for securing and stabilizing the lead at a target location in a patient's heart. The fixation helix is adapted to extend from a first position disposed over the electrode to a second position located distally to the distal end of the cardiac lead.

Description

CARDIAC LEAD WITH A RETRACTABLE HELIX
CROSS REFERENCE TO RELATED APPLICATION
[001] The present application claims priority to U.S. Patent
Application No. 11/557,815, filed November 8, 2006, entitled "CARDIAC LEAD WITH A RETRACTABLE HELIX" which is incorporated herein by reference in its entirety.
TECHNICAL FIELD
[002] The present invention relates to the field of medical leads. More specifically, the present invention is directed to a medical electrical lead having an extendable and retractable helix for securing the distal end of the cardiac lead within a cardiac chamber.
BACKGROUND
[003] Implantable medical devices for treating irregular contractions of the heart with electrical stimuli are well known. Exemplary implantable devices are defibrillators and pacemakers. Various types of electrical leads for defibrillators and pacemakers have been suggested, many of which are placed transvenously. Such leads are introduced into the patient's vasculature at a venous access site and travel through veins to the sites where the leads' electrodes will be implanted or otherwise contact target coronary tissue. Electrodes for transvenously-placed leads can be implanted in the myocardium of the right atrium or ventricle, or alternatively, another location within the coronary venous system.
[004] Various techniques have been used to facilitate fixation of the foregoing types of leads at the desired implantation sites. For leads implanted within a cardiac chamber, fixation techniques should provide fixation stable enough to withstand natural heart motion and retrograde blood flow which tend to push the lead out of the location into which the electrode is implanted. Additionally, it is desirable to permit and facilitate repositioning or removal of the lead and fixation structures after implantation if necessary or desired.
[005] Helixes for fixing leads are known in the art. It is also recognized that the larger the helix is in diameter, the more stable fixation it provides. In a typical lead configuration, a fixation helix is extended and retracted from a position located internally within the lead body or catheter. As such, the size of the fixation helix used to secure lead bodies is limited by the diameter of the lead body or catheter. The size and type of electrode that is placed within the lead is also limited by this configuration.
[006] Accordingly, there is a continuing need for improved devices and methods for fixation of cardiac leads in the coronary system. In particular, there is a need in the art for a fixation approach that effectively secures and stabilizes the lead electrodes in the target coronary location while still permitting subsequent removal of the lead.
SUMMARY
[007] The present invention, according to one embodiment, is a cardiac rhythm management system including a pulse generator adapted to deliver a therapy to a patient's heart, and an electrical lead, including an electrical lead body and proximal and distal portions. The proximal portion is operatively coupled to the pulse generator and the distal portion is disposed in a heart chamber. The cardiac rhythm management assembly also includes at least one electrode located at the distal end of the electrical lead and a fixation helix adapted to extend from a first position disposed over the distal portion of the electrical lead including the electrode to a second position located distally to the distal end of the electrical lead. In another embodiment of the present invention, the cardiac rhythm management system further includes an actuation mechanism adapted to manipulate the fixation helix from the first position to the second position. [008] According to another embodiment of the present invention, a cardiac rhythm management system includes a pulse generator adapted to deliver a therapy to a patient's heart; an electrical lead including a proximal portion and a distal portion, the proximal portion operatively coupled to the pulse generator and the distal portion disposed in a chamber of the heart; a fixation helix having a proximal end and a distal end, the fixation helix coupled to the electrical lead; and at least one electrode located at a distal end of the electrical lead. The electrode is disposed within the fixation helix and adapted to move from a distal position to a proximal position located within the fixation helix.
[009] According to yet another embodiment of the present invention a lead for placement at a site located within a chamber of a heart includes an electrical lead body; a proximal portion; a distal portion; at least one electrode; and a fixation means disposed over the electrode for securing the distal end of the lead in the heart chamber. [010] According to yet another embodiment of the present invention, a cardiac rhythm management system includes: a pulse generator adapted to deliver a therapy to a patient's heart; an electrical lead having a lead body and a proximal portion and a distal portion, the distal portion disposed in a chamber of the heart; at least one electrode located at a distal end of the electrical lead; and a fixation helix disposed over the distal portion of the lead including the electrode. The fixation helix is configured so as not to snag tissue during insertion of the lead into a patient's vasculature.
[011] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS
[012] FIG. 1 is a perspective view of a pulse generator coupled to a lead deployed in a patient's heart according to one embodiment of the present invention.
[013] FIG. 2A is a side plan view and FIG. 2B is a sectional view of a distal portion of the lead shown in FIG. 1. As shown in FIG. 1 , a fixation helix is retracted over the distal end the lead.
[014] FIG. 2C is side plan view and FIG. 2D is a sectional view of the distal portion illustrated in FIG. 1. As shown, the fixation helix extends over the distal end of the lead.
[015] FIG. 3 is a perspective view of the fixation helix of the present invention.
[016] FIG. 4 is a sectional view of a stylet engaging a distal portion of a lead shown in FIGS. 2A-2D according to an embodiment of the present invention.
[017] FIG. 5A is a side plan view and FIG. 5B is a sectional view of a distal portion of a lead shown in FIG. 1 according to an embodiment of the present invention.
[018] FIG. 5C is a side plan view of the distal portion illustrated in FIG.
1. As shown, the fixation helix extends over the distal portion of the lead.
[019] FIG. 6 is a sectional view of a stylet engaging a distal portion of a lead shown in FIGS. 5A-5C according to an embodiment of the present invention.
[020] FIGS. 7A and 7B show a sectional view of a distal portion of a lead shown in FIG. 1 according to an embodiment of the present invention.
[021] While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION
[022] FIG. 1 shows a cardiac rhythm management system 4 in accordance with the present invention. The cardiac rhythm management system 4 includes a pulse generator 6 coupled to an electrical lead 8 deployed in a patient's heart 10 through a superior vena cava 12. As shown in FIG. 1 , the heart 10 includes a superior vena cava 12, a right atrium 14, a right ventricle 16 having an apex 17, a ventricular septum 18, a ventricular outflow tract 20, which leads to a pulmonary artery 22 having a pulmonary valve 24, a left ventricle 26, and a left atrium 28. In one embodiment, the lead 8 is adapted to deliver an electrical pulse, such as a pacing pulse or defibrillation, to the heart 10 via an electrode 36 positioned in the right ventricle 16 near the right ventricular apex 17.
[023] The lead 8 includes an elongate, flexible lead body 40 and a proximal portion 42 and a distal portion 44. The lead 8 also includes one or more conductors, such as a coiled conductor, for conducting energy from the pulse generator 6 to the heart 10, and also to receive signals from the heart 10. Additionally, the lead 8 may have a co-radial design. The lead 8 further includes outer insulation 45 to insulate the conductor. The conductor or conductors are coupled to one or more electrodes, such as electrode 36. In one embodiment of the present invention, the lead 8 includes a lumen for receiving a guiding element such as a guide wire or a stylet.
[024] The proximal portion 42 is operatively coupled to the pulse generator 6. Additionally, the proximal portion 42 is operable to manipulate the distal portion 44 of the lead 8 through the vasculature to position the distal end 46 of the lead 8 including the electrode 36 into a target location within a heart chamber using techniques well known in the art. It is appreciated that the lead 8 can be deployed to alternate locations within the heart such as the left side of the heart as is known in the art (e.g. the left ventricle).
[025] In one embodiment of the present invention, the distal portion 44 is guided through the superior vena cava 12 and the right atrium 14 to a target position located near the right ventricular apex 17 of the heart 10. The distal portion 44 of the lead 8 includes at least one electrode 36 at the distal end 46 of the lead body 40. The distal end 46 of the lead 8 is secured to the myocardium using a fixation device. According to an embodiment of the present invention, the fixation device is a fixation helix that extends and retracts over a distal portion 44 of the lead body 40 including the electrode 36 located at a distal end 46 of the lead 8.
[026] FIGS. 2A-2D show multiple views of the distal portion 44 of the lead 8 in accordance with the present invention. The distal portion 44 of the lead 8 includes a distal end region 60 including a distal assembly 71, a distal sheath 75, an electrode 80, and a fixation helix 82. The electrode 80 is located within the distal sheath 75 and includes an electrode tip 84. The fixation helix 82 is coupled to the distal assembly 71 , and is disposed over the distal sheath 75 and the electrode 80. According to a further embodiment of the present invention the fixation helix 82 is rotatably disposed over the sheath 75. [027] As illustrated in FIGS. 2B and 2D, the electrode 80 is disposed within the distal sheath 75 and is located at a distal end 46 of the lead body 40. The electrode 80 is in electrical communication with the distal end 46 of the lead 8 through a conductor 86 deposited axially along an inner surface of the distal sheath 75. The conductor 86 communicates with the conductor coil in the lead body 40 through a secondary conductor coil 87 located in the distal portion 44 of the lead 8. In one embodiment, the outer surface of the distal sheath 75 is coated with a nonconductive material such as is known in the art (e.g. paralyene). This prevents electrical noise or "chatter" from interfering with the electrical pulse produced by the electrode 80. The electrode 80 can have any configuration as is known in the art. According to one embodiment, the electrode 80 has a generally hemi-spherical configuration. According to another embodiment, the electrode 80 is a slotted tip electrode and includes an electrode tip 84 and a reservoir 88. The reservoir 88 is adapted to hold and deliver a drug to the myocardial tissue at a target location within the heart 10. In one embodiment of the present invention, the drug is a steroid for reducing inflammation at the target location. Alternatively, the drug can be any other drug or therapeutic agent known in the art for delivering therapy to a patient's heart 10. Furthermore, it is appreciated that other medical devices such as sensors and the like can be adapted to be positioned and secured using the features of the present invention. [028] As best viewed in FIGS. 2B and 2D, the distal assembly 71 includes a distal shaft 92, a distal assembly housing 93, and a rotatable pin 94. The pin 94 travels in a groove 96 (best viewed in FIGS. 2A and 2C) located in the distal sheath 75. The groove 96 includes stop regions 98 and 99, and controls the advancement and rotation of the fixation helix 82. Actuation of the pin 94 within the distal assembly 71 rotates the fixation helix 82 over the distal sheath 75 and electrode 80 in a proximal or distal direction. In FIGS 2A-2D a turn pin 100 is used to rotate the inner conductor coil, thus causing the pin 94 located within the distal assembly 71 to rotate the fixation helix 82 over the distal sheath 75 and electrode 80 in a distal direction. [029] The fixation helix 82 includes a proximal end 102, a distal end 104, and a tip 106. According to an embodiment of the present invention, the fixation helix 82 rotatably extends and retracts independently of the electrode 80 disposed within the distal sheath 75. The fixation helix 82 extends and retracts from a retracted position 108 (shown in FIG. 2A) to an extended position 110 (shown in FIG. 2B), and moves relative to the sheath 75. The groove 96 located in the distal sheath 75 controls the advancement of the fixation helix by providing stop regions 98 and 99 for both the extension and retraction of the helix. When a distal rotation force is applied to the distal assembly 71 , the stop region 99 prevents the fixation helix from being extended too far beyond its intended extended position 110. Similarly, when a proximal rotational force is applied, the stop region 98 prevents the fixation helix from being retracted too far over the distal sheath 75. These features allow the fixation helix 82 to be more easily retracted and redeployed during repositioning of the lead 8 at the target location. Additionally, they allow the fixation helix 82 to be extended and retracted in a controlled manner. In one embodiment, the extended position 110 is located distally to the distal end 46 of the lead 8. In another embodiment, the extended position 110 is located distally to the electrode tip 84. In a further embodiment, the fixation helix 82 is capable of extending a distance from about 1.5 mm to about 2 mm as measured from the electrode tip 84. In yet another embodiment, when in the retracted position 108, the distal end 104 of the fixation helix 82 is radially aligned with the electrode tip 84.
[030] According to an embodiment of the present invention, the fixation helix 82 is in the retracted position 108 when the lead 8 is guided through the vasculature and positioned at the target site. In this position, the tip 106, best viewed in FIG. 3 discussed below, will not snag on the vascular tissue as the lead 8 is guided through the vasculature. During manufacture the tip 106 is ground such that it deflects inward towards an interior of the helix 82. It is this configuration that allows the tip 106 not to snag on the vascular tissue as the lead 8 is guided through a patient's vasculature system. In an embodiment of the present invention, the tip 106 includes one facet. In another embodiment of the present invention, the tip 106 of the helix 82 may include two or more facets for engaging the myocardial tissue at the target location. According to alternate embodiments of the present invention, the tip 106 shape may be configured to be pyramidal, conical, blunt, rounded, or another shape as known in the art. Once the helix 82 is in the extended position 110, the tip 106, despite its inward deflection, is capable of engaging the myocardial tissue at the target location. [031] The present invention allows for a larger fixation helix 82 to be used to secure the lead 8 having a predetermined diameter at a target location as the fixation helix 82 is disposed over the distal portion 44 of the lead body 40. An outer catheter or guiding member provided for the purpose of protecting the helix 82 is not required as the helix tip 106 will not snag tissue in its retracted position 108. Larger helixes are more capable of withstanding the contractions of the heart and, thus, are more stable for securing leads. In one embodiment of the present invention, the outer diameter of the fixation helix 82 ranges from about 0.045 inches to about 0.092 inches. In another embodiment of the present invention, the outer diameter of the fixation helix 82 ranges from about 0.045 to about 0.050 inches. In yet another embodiment, the outer diameter of the fixation helix ranges from about 0.050 to about 0.079 inches. In yet a further embodiment, the outer diameter of the fixation helix ranges from about 0.079 to 0.092 inches. [032] FIG. 3 shows the fixation helix 82 according to an embodiment of the present invention. The helix 82 includes a proximal end 102, a distal end 104, and a helix body 110 extending there between. Located at the distal end 104 is the helix tip 106. The material for forming the helix includes, but is not limited to, the following: Nitinol, NiTi alloy, titanium, spring temper 316 SS, MP35N, platinum or platinum alloy, polyurethane, bio-compatible polymers or another material as is known in the art. In one embodiment, the helix is a wire coil including a non-conductive outer coating. The non-conductive coating coats 100% of the wire helix and ranges from about 4 to about 5 microinches thick. In an alternate embodiment, the coil itself is nonconductive. The turns 107 of the helix 82 maintain a constant pitch (frequency) over a specified length of the helix body 110. In the present invention the pitch ranges from about 0.030 to about 0.050 inches. Additionally a proximal end 102 of the helix 82 includes a minimum of two full turns having a more tightly wound pitch than the specified length of the helix body 110. There is a smooth transition from the tightly wound proximal end 102 of the helix 82 to the helix body 110 having a constant pitch.
[033] When the helix 82 is in the second position 110, the helix tip 106 is capable of engaging the myocardial tissue at the target location. According to an embodiment of the present invention, the helix 82 rotatably engages the myocardial tissue at the target location through the actuation of the distal assembly 71 located within the distal portion 60 of the lead 8, as shown in FIGS. 2A-2D. The helix tip 106 is rotated into the myocardial tissue until it is secured and stabilized in the target location.
[034] According to the embodiment of the present invention shown in FIG. 4, a stylet 114 is inserted into a lumen 116 provided in the lead 8. The stylet 114 is used to actuate the distal assembly 71 provided at the distal end region 60 of the lead 8. The stylet 114 includes a distal end 118 and is operated at the proximal portion 42 of the lead 8. According to one embodiment of the present invention, the distal end 118 of the stylet 114 is adapted to rotatably engage a slot 120 located on the distal shaft 92 and adapted to rotatably receive the distal end 118 of the stylet 114. When the stylet 114 is engaged in the slot 120 located on the distal shaft 92, the stylet 114 is used to rotate the distal assembly 71 thus rotating the fixation helix 82. Pushing and rotating the distal shaft 92 in a distal direction causes the pin 94 to travel through the groove 96 located in the distal sheath 75 extending the helix 82 from a retracted position 108 located over the distal portion 44 of the lead body 40 including the electrode 80 to an extended position 110 located distally the distal end 46 of the lead body 40. The helix 82 can be further rotated to engage the myocardial tissue at the target location. The stylet 114 is operated in the opposite direction to disengage the helix from the myocardial tissue and to retract the helix from the extended position 110 to its retracted position 108. The lead 8 can then be either repositioned or retrieved.
[035] In an alternate embodiment illustrated in FIGS. 5A-5C, the lead 8 includes a distal portion 200 including a distal assembly 210, a distal sheath 215, an electrode 220 including an electrode tip 221 , and a fixation helix 225. The distal portion 200 also includes a spring 227 (shown in FIG. 2B). The fixation helix 225 couples with the distal assembly 210 and is disposed over the distal sheath 215 including the electrode 220. In this embodiment, as shown in FIG. 5B, the distal assembly 210 includes a distal shaft 232, a locking pin 234, and a slot 240 provided in the distal sheath 215. The locking pin 234 is slideably engaged in the slot 240. In one embodiment of the present invention, the slot 240 is a J-shaped slot. In alternative embodiments of the present invention the slot 240 can have any appropriate shape as is known in the art for slideably engaging and locking a pin 234. The locking pin 234 slides from a proximal position 246 in the J-shaped slot 240 to a distal position 248 located in the end portion of the J-shaped slot 240. The spring 227 places a tension or distal force on the pin 234 as the pin 234 moves from a proximal position 246 to a distal position 248. Additionally, the spring 234 facilitates securing the pin 234 in the curved portion of the J-shaped slot 240 by placing a distal force on the pin 234 as it is held in the end portion 248 of the J-shaped slot 234. Once the pin 234 is released from the end portion 248 of the J-shaped slot 234, the spring allows the pin 234 to easily retract from a distal position 248 to a proximal position 246 within the slot 240. [036] FIG. 6 is a sectional view of a stylet engaging a distal portion of a lead as shown in FIGS. 5A-5C. According to one embodiment of the present invention, as shown in FIG. 6, the distal shaft 232 includes a slot 235 sized to rotatably receive a flat portion of a stylet for manipulating the locking pin 234 in the J-shaped slot 240. A stylet 250 is inserted into a lumen provided in the lead 8. The stylet 250 includes a distal end 262 adapted to rotatably engage the slot 235 located on the distal shaft 232 of the distal assembly 210. A physician uses the stylet 250 to push on the locking pin 234 causing the locking pin 234 to slide from a proximal position 246 to a distal position 248 in the J- shaped slot 240 provided in a distal sheath 215. As this process occurs, the fixation helix 225 extends from a retracted position to an
- i i - extended position located distally to a distal end 46 of the lead body 40. In another embodiment according to the present invention, the fixation helix 225 extends from a retracted position to an extended position located distally to the electrode tip 221. The stylet 250 is then used to lock or secure the fixation helix 225 in place by positioning the locking pin 234 in the curved portion of the J-shaped slot 240. The lead body 40, using techniques well known in the art, is then rotated in a first direction to engage and secure the fixation helix 225 in the myocardial tissue at the target site in a patient's heart. [037] To release the helix, the operations are reversed. The lead body 40 is rotated in a second, opposite direction to disengage the fixation helix 225 from the myocardial tissue at the target location. Then, the physician pushes forward on the stylet 250 to release the locking pin 234 from the curved portion of the J-shaped slot 240. The locking pin 234 is allowed to slide from a distal position 248 back to a proximal position 246. The lead 8 then can be repositioned at the target location or removed.
[038] According to another embodiment of the present invention shown in FIGS. 7A and 7B, the distal portion 300 of a lead 8 includes a distal assembly 306 including a distal sheath 310, an electrode 315 disposed within the distal sheath 310, and a fixation helix 320. Additionally, the electrode 315 is coupled to a drive shaft 318 located within the distal sheath 310. The drive shaft 318 includes threads 321 on an outer portion 322 of the shaft 318 and is threadably engaged with threads 324 disposed on an inner portion 325 of the distal sheath 310. The fixation helix 320 extends over a distal end 326 of the lead body 40 to a point distal to an electrode tip 328. In this embodiment, the fixation helix 320 is stationary with respect to the distal sheath 310. The distal position 330 of the electrode tip 328 within the fixation 320 prevents the fixation helix 320 from snagging on any myocardial tissue during the insertion and deployment of the lead 8. After deployment of the lead 8 into a cardiac chamber, the lead body 40 is rotated using techniques well known in the art to secure and stabilize the fixation helix 320 in the myocardial tissue at the target location in a patient's heart. Then, the electrode 315 is moved within the fixation helix 320 from a distal position 330 located distally to a distal end 46 of the lead 8 to a proximal position 332. According to one embodiment of the present invention, in the distal position 330, the electrode tip 328 is in close proximity to the myocardial tissue. In another embodiment of the present invention, the electrode tip 328 contacts the myocardial tissue at the target location. The electrode position can be selected and adjusted as necessary.
[039] According to one embodiment of the present invention, as shown in FIG. 7A-7B, the lead 8 includes a terminal drive mechanism 350 having an inner coil 352 extending the length of the lead body 40. The inner coil 352 includes a terminal end 354 adapted to rotatably engage a recess 356 provided on the drive shaft 318 located within the distal sheath 310. A fixation tool 358 is provided at the proximal end 42 of the lead body 40. The fixation tool 358 is adapted to rotatably engage a proximal end 360 of the inner coil 352. The fixation tool 358 is used to actuate the terminal drive mechanism 350 by rotating the inner coil 352 to engage and rotate the drive shaft 318 located within the distal sheath 310. Rotation of the drive shaft 318 in a first direction moves the electrode 315 from a distal position 330 to a proximal position 332. According to one embodiment of the present invention, when the electrode 315 is in the distal position 330, the electrode 315 is in close proximity to the myocardial tissue at the target location. In alternate embodiments, the electrode 315 can contact the myocardial tissue at the target location. To remove or reposition the lead 8, the lead body 40 is rotated to disengage the fixation helix 320 from the myocardial tissue at the target location. The lead 8 can then either be repositioned or removed.
[040] A lead including a distal portion having a fixation helix described according to the various embodiments discussed above can be deployed in a patient's heart using standard techniques known to those of skill in the art. As the helix is designed not to snag on cardiac tissue
- IJ - during insertion and deployment, a guide catheter or protective outer sheath is not required. This allows flexibility in determining lead and fixation helix diameter. For example, a small diameter lead may be selected having a large fixation helix disposed over an outer surface of a distal portion of the lead, optimizing fixation stability of the lead at the target location.
[041] The fixation helix, according to the various embodiments of the present invention, allows the lead to be repositioned or removed from its target location within a patient's heart. If a clinician desires to reposition the lead, the fixation helix may be retracted from the extended position to the retracted position allowing the lead to be repositioned. The fixation helix can then be used again to secure the lead at the target location. Alternatively, the fixation helix can be retracted and the lead removed. According to another embodiment of the present invention, the fixation helix is capable of substantially permanent deployment to the target location to prevent the lead from becoming dislodged or repositioned during use. [042] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

Claims

CLAIMS We claim:
1. A cardiac rhythm management system comprising: a pulse generator adapted to deliver a therapy to a patient's heart;
an electrical lead comprising a lead body and a proximal portion and a distal portion, the proximal portion operatively coupled to the pulse generator and the distal portion disposed in a chamber of the heart;
at least one electrode located at a distal end of the electrical lead; and
a fixation helix disposed over the distal portion of the lead including the electrode, the fixation helix adapted to extend from a retracted position disposed over the distal portion of the lead to an extended position located distally to the distal end of the electrical lead.
2. The cardiac rhythm management system according to claim 1 , comprising an actuation mechanism adapted to extend the fixation helix from the retracted position disposed over the distal portion of the lead to an extended position located distally to the distal end of the electrical lead, the actuation mechanism comprising a distal assembly including a distal shaft and a rotatable pin, wherein the fixation helix is coupled to the distal assembly.
3. The cardiac rhythm management system according to claim 1 , wherein the fixation helix is adapted to retract from the extended position located distally to the distal end of the lead to the retracted position.
4. The cardiac rhythm management system according to claim 1 , wherein the fixation helix moves independently of the electrode.
5. The cardiac rhythm management system according to claim 1 , wherein the fixation helix is non-conductive.
6. The cardiac rhythm management system according to claim 1, wherein the fixation helix is conductive.
7. The cardiac rhythm management system according to claim 1 , wherein when the fixation helix is in the retracted position it will not snag tissue.
8. The cardiac rhythm management system according to claim 1 , wherein an outer diameter of the fixation helix ranges from about 0.045 to about 0.092 inches.
9. The cardiac rhythm management system according to claim 1 , wherein an outer diameter of the fixation helix ranges from 0.079 to 0.092 inches.
10. The cardiac rhythm management system according to claim 1 , wherein the electrode comprises a reservoir for holding and delivering a therapeutic agent.
11. The cardiac rhythm management system according to claim 1 , wherein the electrode is a slotted tip electrode.
12. A cardiac rhythm management system comprising: a pulse generator adapted to deliver a therapy to a patient's heart;
an electrical lead including a proximal portion and a distal portion, the proximal portion operatively coupled to the pulse generator and the distal portion disposed in a chamber of the heart;
a fixation helix having a proximal end and a distal end, the fixation helix coupled to the electrical lead; and
at least one electrode located at a distal end of the electrical lead, the electrode disposed within the fixation helix and adapted to move from a distal position located within the fixation helix to a proximal position.
13. The cardiac rhythm management system according to claim 12 further comprising an actuation mechanism for moving the electrode from the distal position located within the fixation helix to the proximal position.
14. The cardiac rhythm management system according to claim 13, wherein the actuation mechanism comprises a terminal drive mechanism.
15. The cardiac rhythm management system according to claim 12, wherein the electrode is a slotted tip electrode.
16. The cardiac rhythm management system according to claim 12, wherein the electrode comprises a reservoir for holding and delivering a therapeutic agent.
17. The cardiac rhythm management system according to claim 12, wherein an outer diameter of the fixation helix ranges from about 0.045 to about 0.092 inches.
18. A lead for placement at a site located within a chamber of a heart, the lead comprising: an electrical lead body and a proximal portion and a distal portion;
at least one electrode located at a distal end of the lead body; and
a fixation means disposed over the electrode for securing the distal end of the lead in the heart chamber.
19. The lead according to claim 18, wherein the fixation means moves relative to the distal portion of the electrical lead body.
20. The lead according to claim 18, wherein the electrode moves relative to the fixation means.
21. A cardiac rhythm management system comprising: a pulse generator adapted to deliver a therapy to a patient's heart;
an electrical lead comprising a lead body and a proximal portion and a distal portion, the proximal portion operatively coupled to the pulse generator and the distal portion disposed in a chamber of the heart;
at least one electrode located at a distal end of the electrical lead; and
a fixation helix disposed over the distal portion of the lead including the electrode, wherein the fixation helix is configured so as not to snag tissue during insertion of the lead into a patient's vasculature.
22. The cardiac rhythm management system according to claim 21 , wherein the fixation helix moves relative to the distal portion of the lead and is adapted to extend from a retracted position disposed over the distal portion to an extended position located distally to the electrode located at the distal end of the lead.
23. The cardiac rhythm management system according to claim 21 , wherein the fixation helix is stationary relative to the distal portion of the lead and the electrode moves within the fixation helix from a distal position to a proximal position.
24. The cardiac rhythm management system according to claim 21 , wherein the fixation helix is non-conductive.
25. The cardiac rhythm management system according to claim 21 , wherein the fixation helix is conductive.
26. The cardiac rhythm management system according to claim 21 , wherein an outer diameter of the fixation helix ranges from about 0.045 to about 0.092 inches.
PCT/US2007/077528 2006-11-08 2007-09-04 Cardiac lead with a retractable helix WO2008057651A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2009535373A JP2010508904A (en) 2006-11-08 2007-09-04 Cardiac lead with retractable helix
EP07841821A EP2079509A1 (en) 2006-11-08 2007-09-04 Cardiac lead with a retractable helix

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/557,815 US7657326B2 (en) 2006-11-08 2006-11-08 Cardiac lead with a retractable helix
US11/557,815 2006-11-08

Publications (1)

Publication Number Publication Date
WO2008057651A1 true WO2008057651A1 (en) 2008-05-15

Family

ID=38923135

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/077528 WO2008057651A1 (en) 2006-11-08 2007-09-04 Cardiac lead with a retractable helix

Country Status (4)

Country Link
US (1) US7657326B2 (en)
EP (1) EP2079509A1 (en)
JP (1) JP2010508904A (en)
WO (1) WO2008057651A1 (en)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2003272951A1 (en) * 2002-11-19 2004-06-15 Nihon University Balloon catheter and device for injecting medical treatment method
US8449606B2 (en) 2005-10-26 2013-05-28 Cardiosolutions, Inc. Balloon mitral spacer
US8778017B2 (en) 2005-10-26 2014-07-15 Cardiosolutions, Inc. Safety for mitral valve implant
US7785366B2 (en) 2005-10-26 2010-08-31 Maurer Christopher W Mitral spacer
US8852270B2 (en) 2007-11-15 2014-10-07 Cardiosolutions, Inc. Implant delivery system and method
US9259317B2 (en) 2008-06-13 2016-02-16 Cardiosolutions, Inc. System and method for implanting a heart implant
US8216302B2 (en) 2005-10-26 2012-07-10 Cardiosolutions, Inc. Implant delivery and deployment system and method
US8092525B2 (en) 2005-10-26 2012-01-10 Cardiosolutions, Inc. Heart valve implant
ATE511877T1 (en) * 2005-11-30 2011-06-15 St Jude Medical ENDOCARDIAL CONDUCTIVITY
US8480730B2 (en) * 2007-05-14 2013-07-09 Cardiosolutions, Inc. Solid construct mitral spacer
US8597347B2 (en) 2007-11-15 2013-12-03 Cardiosolutions, Inc. Heart regurgitation method and apparatus
WO2009079037A1 (en) 2007-12-14 2009-06-25 Cardiac Pacemakers, Inc. Fixation helix and multipolar medical electrode
EP2265323B1 (en) * 2008-03-17 2016-09-07 Surgivision, Inc. Low profile medical devices with internal drive shafts that cooperate with releasably engageable drive tools
US8591460B2 (en) 2008-06-13 2013-11-26 Cardiosolutions, Inc. Steerable catheter and dilator and system and method for implanting a heart implant
WO2010114429A1 (en) 2009-03-31 2010-10-07 St. Jude Medical Ab A medical implantable lead and a method for manufacturing of such a lead
US8634933B2 (en) 2010-05-17 2014-01-21 Cardiac Pacemakers, Inc. Active fixation leads and method of assembly
EP2654889B1 (en) * 2010-12-20 2017-03-01 Pacesetter, Inc. Leadless pacemaker with radial fixation mechanism
US8755909B2 (en) 2012-06-01 2014-06-17 Medtronic, Inc. Active fixation medical electrical lead
US9694172B2 (en) 2013-03-12 2017-07-04 Cardiac Pacemakers, Inc. Implantable medical devices with separate fixation mechanism
US9232998B2 (en) 2013-03-15 2016-01-12 Cardiosolutions Inc. Trans-apical implant systems, implants and methods
US9289297B2 (en) 2013-03-15 2016-03-22 Cardiosolutions, Inc. Mitral valve spacer and system and method for implanting the same
JP6731339B2 (en) 2013-06-14 2020-07-29 カーディオソリューションズ インコーポレイテッドCardiosolutions, Inc. Mitral valve spacer and implantation system and method thereof
US10315028B2 (en) 2014-04-23 2019-06-11 Medtronic, Inc. Active fixation medical electrical lead
FR3022790A1 (en) * 2014-06-25 2016-01-01 Sorin Crm Sas IMPLANTABLE FASTENING CAPSULE, IN PARTICULAR AN AUTONOMOUS CARDIAC STIMULATION CAPSULE
EP2959936B1 (en) * 2014-06-25 2021-03-31 Sorin CRM SAS Implantable capsule with attachment by screwing, in particular an autonomous cardiac stimulation capsule
US10737102B2 (en) 2017-01-26 2020-08-11 Cardiac Pacemakers, Inc. Leadless implantable device with detachable fixation
NL2019577B1 (en) 2017-09-19 2019-03-28 Cardiac Pacemakers Inc Stimulation/sensing electrode fixation device and electrical lead
JP7036920B2 (en) 2017-11-06 2022-03-15 ペースセツター、インコーポレイテツド Biostimulator with fixed elements
CN112020374A (en) 2018-04-23 2020-12-01 心脏起搏器股份公司 Multipolar lead for bundle of his pacing
US11577086B2 (en) 2018-08-20 2023-02-14 Pacesetter, Inc. Fixation mechanisms for a leadless cardiac biostimulator
CN112714662A (en) 2018-10-16 2021-04-27 心脏起搏器股份公司 Bundle of his leads with extendable electrodes and repositioning features
USD894396S1 (en) 2019-03-08 2020-08-25 Pacesetter, Inc. Leadless biostimulator attachment feature
US11541243B2 (en) 2019-03-15 2023-01-03 Pacesetter, Inc. Biostimulator having coaxial fixation elements

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5447533A (en) * 1992-09-03 1995-09-05 Pacesetter, Inc. Implantable stimulation lead having an advanceable therapeutic drug delivery system
US5575814A (en) 1995-01-27 1996-11-19 Medtronic, Inc. Active fixation medical electrical lead having mapping capability
US20040059404A1 (en) * 2002-09-24 2004-03-25 Bjorklund Vicki L. Deployable medical lead fixation system and method
US20040068299A1 (en) * 2002-10-02 2004-04-08 Laske Timothy G. Active fluid delivery catheter
WO2004028348A2 (en) * 2002-09-26 2004-04-08 Savacor, Inc. Cardiovascular anchoring device and method of deploying same

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2732547A1 (en) * 1977-07-19 1979-02-01 Bisping Hans Juergen IMPLANTABLE ELECTRODE
US4282885A (en) * 1978-08-21 1981-08-11 Bisping Hans Juergen Electrode for implantation in the heart
DE3708133A1 (en) 1987-03-13 1988-09-22 Bisping Hans Juergen IMPLANTABLE ELECTRODE PROBE WITH EXTENDABLE SCREW ELECTRODE
US5003992A (en) 1989-08-23 1991-04-02 Holleman Timothy W Atraumatic screw-in lead
US5076285A (en) * 1990-03-30 1991-12-31 Medtronic, Inc. Screw-in lead
US5129404A (en) 1990-12-21 1992-07-14 Intermedics, Inc. Implantable endocardial lead with retractable fixation apparatus
US5259395A (en) * 1992-01-15 1993-11-09 Siemens Pacesetter, Inc. Pacemaker lead with extendable retractable lockable fixing helix
FR2724566A1 (en) * 1994-09-16 1996-03-22 Dev Sed Soc Et Motorised cardiac probe with electrode and retractable helix
US6086582A (en) * 1997-03-13 2000-07-11 Altman; Peter A. Cardiac drug delivery system
US5876431A (en) * 1997-07-30 1999-03-02 Sulzer Intermedics Inc. Small cable endocardial lead with exposed guide tube
US6152954A (en) 1998-07-22 2000-11-28 Cardiac Pacemakers, Inc. Single pass lead having retractable, actively attached electrode for pacing and sensing
US6212434B1 (en) 1998-07-22 2001-04-03 Cardiac Pacemakers, Inc. Single pass lead system
US5964795A (en) * 1998-03-13 1999-10-12 Medtronic, Inc. Medical electrical lead
US6296630B1 (en) * 1998-04-08 2001-10-02 Biocardia, Inc. Device and method to slow or stop the heart temporarily
US6256541B1 (en) * 1998-04-17 2001-07-03 Cardiac Pacemakers, Inc. Endocardial lead having defibrillation and sensing electrodes with septal anchoring
US6463334B1 (en) 1998-11-02 2002-10-08 Cardiac Pacemakers, Inc. Extendable and retractable lead
US6269272B1 (en) * 1999-08-03 2001-07-31 Intermedics, Inc. Cardiac pacemaker lead with dual pitch fixation apparatus
US6687550B1 (en) 2001-06-01 2004-02-03 Pacesetter, Inc. Active fixation electrode lead having an electrical coupling mechanism
US6819959B1 (en) 2001-11-21 2004-11-16 Pacesetter, Inc. Extendable/retractable screw-in tip design with an improved thread/screw mechanism
US7158838B2 (en) 2003-01-31 2007-01-02 Medtronic, Inc. Arrangement for implanting a miniaturized cardiac lead having a fixation helix
US20050070984A1 (en) 2003-09-29 2005-03-31 Sundberg Gregory L. Extendable and retractable lead with an active fixation assembly
US20050165452A1 (en) * 2004-01-28 2005-07-28 Medtronic, Inc. Antithrombogenic medical device
US7657325B2 (en) 2005-12-30 2010-02-02 Medtronic, Inc. Implantable medical lead including a helical fixation member

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5447533A (en) * 1992-09-03 1995-09-05 Pacesetter, Inc. Implantable stimulation lead having an advanceable therapeutic drug delivery system
US5575814A (en) 1995-01-27 1996-11-19 Medtronic, Inc. Active fixation medical electrical lead having mapping capability
US20040059404A1 (en) * 2002-09-24 2004-03-25 Bjorklund Vicki L. Deployable medical lead fixation system and method
WO2004028348A2 (en) * 2002-09-26 2004-04-08 Savacor, Inc. Cardiovascular anchoring device and method of deploying same
US20040068299A1 (en) * 2002-10-02 2004-04-08 Laske Timothy G. Active fluid delivery catheter

Also Published As

Publication number Publication date
US7657326B2 (en) 2010-02-02
US20080109042A1 (en) 2008-05-08
EP2079509A1 (en) 2009-07-22
JP2010508904A (en) 2010-03-25

Similar Documents

Publication Publication Date Title
US7657326B2 (en) Cardiac lead with a retractable helix
US20230023767A1 (en) Tube-cut helical fixation anchor for electrotherapy device
EP1545688B1 (en) Medical device delivery system
CN108472485B (en) Compact implantable medical device and delivery device
US8219213B2 (en) Active fixation cardiac vein medical lead
EP2526997B1 (en) Bundle of His stimulation system
US6129750A (en) Fixation mechanism for a coronary venous pacing lead
JP2520373B2 (en) Subcutaneous implantable lead system
EP2051771B1 (en) Medical electrical lead with deployable fixation features
EP3134167B1 (en) Active fixation medical electrical lead
EP0393265A1 (en) Active fixation mechanism for a cardiac stimulating electrode
US20090259283A1 (en) Sheathed lead for pacing or defibrillation
US20060241736A1 (en) Cardiac lead having self-expanding fixation features
US20070293923A1 (en) Lead with orientation feature
US20220313310A1 (en) Interventional medical systems and associated assemblies
CA2050620A1 (en) Multiple electrode deployable lead
US20090198251A1 (en) Lead delivery, fixation and extraction devices and methods for use with intravascular implantable medical devices
US7662132B2 (en) Expandable member for venous lead fixation
US20110071609A1 (en) Biasing and fixation features on leads
US8532792B2 (en) Helix retraction assist mechanism
US8126571B2 (en) Expandable assembly for cardiac lead fixation
US20090192579A1 (en) Implantation methods, systems and tools for intravascular implantable devices
CA2313174A1 (en) Lead system

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 07841821

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2009535373

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2007841821

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE