CA1154833A - Endocardial pacing lead - Google Patents

Endocardial pacing lead

Info

Publication number
CA1154833A
CA1154833A CA000359024A CA359024A CA1154833A CA 1154833 A CA1154833 A CA 1154833A CA 000359024 A CA000359024 A CA 000359024A CA 359024 A CA359024 A CA 359024A CA 1154833 A CA1154833 A CA 1154833A
Authority
CA
Canada
Prior art keywords
lead
electrode
helical coil
coil
helical
Prior art date
Legal status (The legal status 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 status listed.)
Expired
Application number
CA000359024A
Other languages
French (fr)
Inventor
Robert G. Dutcher
Richard D. Sandstrom
James L. Jula
Edward G. O'neill
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic 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 Medtronic Inc filed Critical Medtronic Inc
Application granted granted Critical
Publication of CA1154833A publication Critical patent/CA1154833A/en
Expired legal-status Critical Current

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

Abstract

ABSTRACT OF THE DISCLOSURE
Endocardial pacing lead including a helical coil member extending outwardly through a helical lumen in a guide seal in a distal tip of an electrode for affixing the electrode to heart tissue. A wedge tipped stylet wire rotates a molded tapered sliding member carrying the closed end helical coil within the electrode which penetrates out through a guide seal having a thin closed membrane. A strain relief coil is provided at the junction of the lead and the electrode.

Description

8~ 3 The present invention relates generally to a surgical electrical applicator, and more particularly, pertains to an endocardial pacing lead.
The transvenous endocardial approach is generally accepted as the preferred technique for long term cardiac pacing. This approach is not without complications in that the most significant fa.t is electrode displacement re-sulting in intermittent or complete loss of pacing and/or sensing. Electrode displacement or dislodgement is extremely prevalent ranging from 4.1% to 30%.
The present invention overcomes the difficulties of the prior art by providing a positive fixation endocardial pacing lead.
The general purpose of this invention is to provide a new positive fixation endocardial pacing lead using an extendable retractable helix com-bined with a highly flexible pacing lead including a strain relief member at the junction of the electrode and the conductor of the endocardial pacing lead.
According to one broad aspect of the invention there is provided an endocardial pacing lead comprising a lead, a connector terminal at one end oE
; said lead, and electrode means at the other end of said lead including helical coil fixation means rotatably mounted within said electrode means whereby said helical fixation means rotates thereby securing said electrode means to endo-cardial tissue, said fixation means comprising a closed end helical coil in-cluding a sharp point and a sliding member affixed to said closed end oE said - helical coil and including a rectangular hole in which a stylet wire may be - inserted for rotating said helical coil, said electrode including a guide seal having a helical lumen extending partially therethrough whereby said helical coil rotates through said hole and through the remainder of said guide seal.
According to another broad aspect of the invention there is provided an endocardial pacing lead comprising a lead, a connector at one end of said lead, an electrode assembly at the other end of said lead including an electrode .

:
, 5~8~3 tip, a sleeve located within a rear end of said electrode tip. said lead crimped between said sleeve and said electrode tip, strain relief coil insert-ed over said lead, extending into, between and over said lead and said sleeve, ~; a molded tapered sliding member including a rectangular ftmnelled hole in a rear end and supporting a closed end of a llelical coil at the other end, an open end of said helical coil including a sharp tip, the closed end helical coil and molded tapered sliding member axially mounted within the other end of the electrode tip, a guide seal including a helical coil lumen extending part-ially therethrough and supporting said sharp tipped portion of said helical coil, and a silicone covering extending between said tip electrode to beyond said strain relief coil and over said lead whereby a stylet having a rectangu-lar end is inserted into the molded plastic sliding member and rotated to actually rotate the helical coil out through the closed membrane of the guide ;` seal thereby afEixing said helical coil to myocardial tissue.According to one embodiment of the present invention, there is pro-vided an endocardial pacing lead including an electrode assembly, a conductor affixed to the electrode assembly and ha~ing a connector on the other end, the electrode assembly including an extendable retractable heli~ rotatably mounted within the electrode whereby a stylet wire is inserted down through the connect-or and pacing lead which engages within the helical assembly thereby rotating the helix assembly and anchoring the electrode to heart tissue.
A significant aspect and feature of the present invention is an endo-cardial pacing lead having positive fixation for permanent unipolar ventricular pacing. An active tissue penetrating fixation member in the form of a platinum-iridium helix coil is extended into the myocardium and retracted inside the body- - of the electrode assembly by rotating a wedge tipped stylet wire. A platinum-iridium endocardial ring-shaped electrode surrounds the fixation helix. In a retracted state, the helix is completely contained within the clistal end portion 1 ~ ~
:
. - , . - .

.. ,. , ~-4 ~

of the electrode assembly of the pacing lead. In a fully extended state, the open end helix coil extends two turns outward beyond the electrode. The helix is used exclusively for lead fixation and is electrically iso]ated from the ring-shaped electrode.
Another significant aspect and feature of the present invention is that the open end helix coil threads into a helical lumen within a silicone rubber guide seal plug located within the distal tip of the electrode assembly of the lead and is covered by a thin silicone rubber membrane which helps prevent blood and tissue from entering the body of the lead while the helix is either retracted or extended.

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5~ 3 A urther signiicant aspect and feature of the present invention is that a standard stainless skeel blunt tip stylet wire is utilized or , initial positioning of the lead in the right ventricle and a special stain-less steel stylet wire with a plastic knob at its proximal end and a wedge - tip at its distal end serve~ as a long 1exible screwdriver which engages a rectangular slot o a plastiG sliding member permanently attached to the helix for rotation of the stylet wire which extends or retracts the helix.
.:
Other objects and many of the attendant advantages of this in-vention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in con-nection with the acco~panying d~awings, ln which like reference numerals designate like parts throughout the FIGURES thereof and wherein:
Figure 1 is a plan view of an endocardial pacing lead;
Figure 2 is a cross-sectional view taken along lines 2-2 of Pigure 1 with a hellcal coil fully retracted, and;
Figure 3 is a cross-sectional exploded view of tlhe electrode assembly with the helical coil extending out through a guide seal.
Figure l, which illustrates a plan view of an en,locardial pacing lead 10, the present invention, shows an electrode assembly 12 on a distal end portion of a lead 1~, a connector 16 on a proximal end portion of the lead 14 and having a connector terminal 18 affixed therein, and a s~ylet 20 inserted through the endocardial pacing lead 10.
Figure 2~ which illustrates a cross-sectional view taken along line 2-2 of Figure 1, shows the electrode assembly 12 as now described in detail. The electrode assembly 12 includes a round cylindrical electrode tip member 22 including a taper 22a to a diameter 22b, and a configured front end 22c including a clrcumferential groove 22d and a rounded swaged tip 22e. The internal diameter 22 accepts a ring 36a of a silicone guide ~- :

' ''' ~ ~: ' . "'.; - ' ' seal 36 as later described in detail, a second internal diameter 22g accommodates a molded tapered sllding member 32 as later described in detail, a third internal diameter 22h accepts a stylet wire 20a of the stylet 20, a fourth internal diameter 22i accepts the space wound trifilar conductor coil 26 and a fifth internal diameter 22j accepts a single filar strain relief coil 30 as later described in detail. A sleeve 24 having an outwardly extendlng flange 24a engages within the internal diameter 22i of the electrode 22. The 1ange 24a abuts the forward end of the intern-al diameter 22i. The inner diameter 24b of the sleeve accepts the stylet wire 20a and the outer diameter 24c is o sufficient diameter providing for clearance for one end of the trifilar space wound coil 26 bet~een an outer diameter 24c and the inner diameter 22i. The coil 26 is retained within the electrode tip 22 along with the sleeve 24 by mechanical crimping at locations 28a and 28b as illustrated in the figure and opposing per-pendicular crimps as not illustrated in the figur0 for purposes of clarity in the illustration. A single filar coil 30 acting as a strain relief coil 30 slides and engages o~er the coil 26 along the inner diameter 22j as illustrated in the Figure. The strain relief coil 30 extends from within the rearward portion of the electrode at 22j beyond and outwardly past the rear of the rearward end of the electrode 22. A molded tapered sliding member 32 including a helical coil 34 axially rotates and mounts within the electrode tip 22. The molded tapered sliding member 32 includes a rearward tapered portion 32a, a rounded cone-shaped funnel portion 32b, and an interior rectangular hole 32c accepting a wedge shaped tip 20b of the stylet wire 20. The closed end helical coil 34 includes a closed end 34a engaged in a base 32d at the closed end of the molded tapered helix - and a sharp pointed edge 34b at the open end o the helical coil 34. The open end of the helical coil 34 fits into a helical lumen 36b of ~he guide :

- : :: , 5 ~ 8 ~

seal 36 made of silicone rubber or other like material by way o example and for purposes of Lllu~tration only. An initial portion of the open end of the helical coil extends throughout the substantial majority o the longitudinal length of the guide seal 36 to a point where a closed me~brane 36c of like material extends across the ront o the guide seal 36. Outward extending rectangular circumferential ring 36a o the guide seal 36 engages into the inner diameter 22 o the electrode tip 22 firmly engaging the guide seal 36 within the interior of the electrode tip 22. The orward end of the electrode 22k is swaged -over the electrode guide seal 36 after the electrode guide seal 36 Ccontaining closed end helical coil 34) and molded tapered sliding member 32 are inserted within the electrode tip 22 orming the rounded swaged tip 22e. ~ outer urethane covering 38 covers ~he elec-trode tip 22J and extends from the coil 26 at the rearward end 221 of the electrode tip 22 to the circumferential groove 22d of the electrode tip 22.
Preferred Mode of Ope~ation ; Figure 3, which illustrates one preerred mode of operation of the endocardial pacing lead 10, shows the wedge tip stylet wire 20b extending ectc.,~.J(c.,~
into and engaged within the wodgc ~hape~hole 32c of the molded tapsred sliding member 32. As the stylet knob 20c ~Pigure 1) is tu~ned, subsequent ; 20 clockwise rotatlon results in the rotation o the molded tapered sliding mem-; ber 32~ the closed end helical coil 34 within the guide seal 36 resulting in the sharp tip 34b penetrating through the ormerly closed top membrane 36c of Figure 2 of silicone rubber guide seal 36 and subsequently afixing to heart tissue in a corkscrew-like operation. The edges 36d o the membrane 36c curl up and over the edge o the helical coil 32 providing a seal between the electrode assembly 12 and the heart tissue. Once two turns of the stylet 20a have been reached affixing the sharp pointed edge 34b of the open end of the helical coil 34 into the heart tissue which can be confirmed through , - "
~ 3 , fluoroscopy or other like operat~on, the stylet 2Q is withdrawni ~ With the fixation closed end hellcal coil 34 ully ret~acted using a standard blunt tip stylet wire ths electrode tip 22 can be positioned . in the right ventricular apex with the aid of fluoroscopy. The blunt tip Stylet wire is then removed and a plastic stylet manipulatiorl tool connects ~; to the proximal end of the lead 10 following which the wedge-shaped . stylet 20 is introduced. Once satisfactory electrode position has been .~ confirmed by electrical instrUmentatiOn~ slight forward pressure is main-tained by either holding the lead 10 in this position or by irmly securing the lead 10 at the venotomy site using a llgature tourniquet.
To achieve positive fixation by extending the helical coil 34 beyond the electrode tip 22, the wedge tipped stylet knob 20 is rotated clockwise within the stylet manipulatio~ tool under fluoroscopic monitoring until two turns of the helical coil ~4 àrè clearly visible beyond the distal tip of the electrode tip 22. The knob is rotated in complete 360 in-crements with no more than six revolutions of the stylet knob being required.
Electrode 22 fixatlon is then verlfied by turning the stylet wire 20 another - one to one and one-half revolutlons fèeling for increased resistance to rotation, then gently pulling back on the leaLd under f.luoroscopic monitoring and feeling or a slight resistance to the pulling, and repeating the electrical measurements after removing the stylet wire for adequate perform-. ance.
The strain relie coil 30 provides for bendi.ng of the pacing lead 14 at the junction of the electrode assembly 12. The coil 30 distributes the strain between the electrode and pacing lead over t:he entirP length of the strain relie coil 30 providing for the integrity of the electrode . assembly 12 in the pacing lead.
; Various modiications can be made to the endocardial pacing :. -7-., , , , 5 ~ 8~

:, lead without d~parting rom the appar0nt scope of the present in-VentioD.

,

Claims (8)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An endocardial pacing lead comprising a lead, a connector terminal at one end of said lead, and electrode means at the other end of said lead in-cluding helical coil fixation means rotatably mounted within said electrode means whereby said helical fixation means rotates thereby securing said elec-trode means to endocardial tissue, said fixation means comprising a closed end helical coil including a sharp point and a sliding member affixed to said clos-ed end of said helical coil and including a rectangular hole in which a stylet wire may be inserted for rotating said helical coil, said electrode including a guide seal having a helical lumen extending partially therethrough whereby said helical coil rotates through said hole and through the remainder of said guide seal.
2. The endocardial pacing lead of Claim 1 wherein said guide seal in-cludes a thin closed membrane through which the remainder of said guide seal rotates.
3. The endocardial pacing lead of Claim 2 wherein said guide seal is silicone rubber.
4. The endocardial pacing lead of Claim 1 wherein said lead is a trifilar space wound coil.
5. The endocardial pacing lead of Claim 1 including a single filar strain relief coil between said lead and said electrode means.
6. The endocardial pacing lead of Claim 1 wherein said closed end helical coil is platinum-iridium.
7. An endocardial pacing lead comprising a lead, a connector at one end of said lead, an electrode assembly at the other end of said lead including an electrode tip, a sleeve located within a rear end of said electrode tip, said lead crimped between said sleeve and said electrode tip, strain relief coil inserted over said lead, extending into, between and over said lead and said sleeve, a molded tapered sliding member including a rectangular funnelled hole in a rear end and supporting a closed end of a helical coil at the other end, an open end of said helical coil including a sharp tip, the closed end helical coil and molded tapered sliding member axially mounted within the other end of the electrode tip, a guide seal including a helical coil lumen extending parti-ally therethrough and supporting said sharp tipped portion of said helical coil, and a silicone covering extending between said tip electrode to beyond said strain relief coil and over said lead whereby a stylet having a rectangular end is inserted into the molded plastic sliding member and rotated to actually rotate the helical coil out through the closed membrane of the guide seal there-by affixing said helical coil to myocardial tissue.
8. A body implantable lead according to Claim 1 or Claim 5 wherein said sliding member further comprises a proximal end having a funnel shaped aper-ture, the rectangular hole of said sliding member located at the small end of said funnel shaped aperture.
CA000359024A 1979-08-27 1980-08-26 Endocardial pacing lead Expired CA1154833A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6994879A 1979-08-27 1979-08-27
US69,948 1979-08-27

Publications (1)

Publication Number Publication Date
CA1154833A true CA1154833A (en) 1983-10-04

Family

ID=22092187

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000359024A Expired CA1154833A (en) 1979-08-27 1980-08-26 Endocardial pacing lead

Country Status (6)

Country Link
JP (1) JPS6025260Y2 (en)
AU (1) AU535664B2 (en)
CA (1) CA1154833A (en)
DE (1) DE3032317A1 (en)
FR (1) FR2464079A1 (en)
NL (1) NL8004629A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9682231B2 (en) 2014-02-26 2017-06-20 Cardiac Pacemakers, Inc. Construction of an MRI-safe tachycardia lead
US9750944B2 (en) 2009-12-30 2017-09-05 Cardiac Pacemakers, Inc. MRI-conditionally safe medical device lead

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4258725A (en) * 1979-09-21 1981-03-31 Medtronic, Inc. Pacing lead with stylet and tapered terminal pin
US4972848A (en) * 1989-08-23 1990-11-27 Medtronic, Inc. Medical electrical lead with polymeric monolithic controlled release device and method of manufacture
FR2696348B1 (en) * 1992-10-01 1994-12-09 Dev Et Electrode for a retractable biological screw cardiac stimulation device.
WO2007064251A1 (en) * 2005-11-29 2007-06-07 St. Jude Medical Ab An implantable lead
WO2011081697A1 (en) * 2009-12-30 2011-07-07 Cardiac Pacemakers, Inc. Apparatus to selectively increase medical device lead inner conductor inductance

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2309749B2 (en) * 1973-02-27 1978-05-24 Siegfried Dr.Med. Dipl.-Ing. Dipl.-Wirtsch.-Ing. Lehr Electrode for medical purposes
DE2533766C2 (en) * 1975-07-29 1986-01-23 Hans-Jürgen Dipl.-Ing. 5100 Aachen Bisping Implantable transvenous pacemaker lead

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9750944B2 (en) 2009-12-30 2017-09-05 Cardiac Pacemakers, Inc. MRI-conditionally safe medical device lead
US9682231B2 (en) 2014-02-26 2017-06-20 Cardiac Pacemakers, Inc. Construction of an MRI-safe tachycardia lead

Also Published As

Publication number Publication date
AU6174080A (en) 1981-03-05
NL8004629A (en) 1981-03-03
AU535664B2 (en) 1984-03-29
DE3032317C2 (en) 1989-05-11
JPS6025260Y2 (en) 1985-07-29
DE3032317A1 (en) 1981-03-26
JPS5633944U (en) 1981-04-02
FR2464079A1 (en) 1981-03-06
FR2464079B3 (en) 1982-07-02

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