Source: http://www.google.com/patents/US6477428?dq=5,581,513
Timestamp: 2017-03-30 01:51:54
Document Index: 2482344

Matched Legal Cases: ['art 101', 'art 101', 'art 101', 'art 101', 'art 101', 'art 101']

Patent US6477428 - Endocardial lead with vinylidene fluoride insulation - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA lead has a flexible lead body which extends from a proximal end to a distal end. The lead body has a conductor coupled with an electrode. At least a portion of the flexible lead body includes a polymer of vinylidene fluoride, or a polymer of vinylidene fluoride and silicone rubber. The polymer of vinylidene...http://www.google.com/patents/US6477428?utm_source=gb-gplus-sharePatent US6477428 - Endocardial lead with vinylidene fluoride insulationAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS6477428 B1Publication typeGrantApplication numberUS 09/514,811Publication dateNov 5, 2002Filing dateFeb 28, 2000Priority dateFeb 28, 2000Fee statusLapsedPublication number09514811, 514811, US 6477428 B1, US 6477428B1, US-B1-6477428, US6477428 B1, US6477428B1InventorsDwight Skinner, Stuart R. Chastain, Mohan Krishnan, Chris ZerbyOriginal AssigneeCardiac Pacemakers, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (7), Non-Patent Citations (2), Referenced by (29), Classifications (6), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetEndocardial lead with vinylidene fluoride insulation
US 6477428 B1Abstract
A lead has a flexible lead body which extends from a proximal end to a distal end. The lead body has a conductor coupled with an electrode. At least a portion of the flexible lead body includes a polymer of vinylidene fluoride, or a polymer of vinylidene fluoride and silicone rubber. The polymer of vinylidene fluoride includes, but is not limited to, a homopolymer, a copolymer, or a terpolymer.
What is claimed: 1. A lead assembly comprising:
a flexible lead body extending from a proximal end to a distal end, the lead body including at least one conductor disposed therein, at least a portion of the flexible lead body comprising a polymer of vinylidene fluoride and a layer of silicone rubber, and where the polymer of vinylidene fluoride comprises an outer layer of insulation; and an electrode assembly including at least one electrode electrically coupled with the conductor. 2. The lead assembly as recited in claim 1, wherein the polymer of vinylidene fluoride comprises a homopolymer.
3. The lead assembly as recited in claim 1, wherein the polymer of vinylidene fluoride comprises a copolymer.
4. The lead assembly as recited in claim 1, wherein the polymer of vinylidene fluoride comprises a terpolymer.
5. The lead assembly as recited in claim 1, wherein the polymer of vinylidene fluoride comprises a heat shrunk layer of insulation.
6. The lead assembly as recited in claim 1, wherein the lead body includes a first leg and a second leg at the distal end of the lead body.
7. A lead assembly comprising:
a flexible lead body extending from a proximal end to a distal end, the lead body including at least one conductor disposed therein, at least a portion of the flexible lead body comprising a polymer of vinylidene fluoride that is mounted over an outside surface of another portion of the flexible lead body comprising silicone rubber; and an electrode assembly including at least one electrode electrically coupled with the conductor. 8. The lead assembly as recited in claim 7, wherein the polymer of vinylidene fluoride comprises a homopolymer.
9. The lead assembly as recited in claim 7, wherein the polymer of vinylidene fluoride comprises a copolymer.
10. The lead assembly as recited in claim 7, wherein the polymer of vinylidene fluoride comprises a terpolymer.
11. The lead assembly as recited in claim 7, wherein the polymer of vinylidene fluoride comprises a heat shrunk layer of insulation.
12. The lead assembly as recited in claim 7, wherein the polymer of vinylidene fluoride comprises an outer layer of insulation.
13. The lead assembly as recited in claim 7, further comprising a pulse generator electrically coupled with the electrode assembly.
14. A lead assembly comprising:
a flexible lead body extending from a proximal end to a distal end, the lead body including at least one conductor disposed therein; at least a portion of the flexible lead body comprising a polymer of vinylidene fluoride, and at least a portion of the flexible lead body comprising silicone rubber, wherein the vinylidene fluoride comprises a first layer of insulation, and the silicone rubber comprising a second layer of insulation that is covered by the first layer of insulation; and an electrode assembly including at least one electrode electrically coupled with the conductor. 15. A method comprising:
increasing the abrasion resistance of a lead assembly having a flexible lead body and at least one electrode, including applying a layer of silicone rubber onto the flexible lead body and applying a layer of a polymer of vinylidene fluoride onto the layer of silicone rubber. 16. The method as recited in claim 15, wherein applying the layer of a polymer of vinylidene fluoride includes heat shrinking a tube of vinylidene fluoride onto the layer of silicone rubber.
17. The method as recited in claim 15, wherein applying a layer of silicone rubber onto the flexible lead body includes applying the layer of silicone rubber onto an electrical conductor in the lead assembly.
18. The method as recited in claim 15, further comprising chronically stimulating heart tissue with the lead assembly.
The present invention relates generally to leads implanted in the heart and for conducting electrical signals to and from the heart. More particularly, it pertains to insulation for an endocardial lead.
Cardiac pacing may be performed by the transvenous method or by leads implanted directly onto the ventricular epicardium. Permanent transvenous pacing is performed using a lead positioned within one or more chambers of the heart. A lead may be positioned in the ventricle or in the atrium through a subclavian vein, and the lead terminal pins are attached to a pacemaker which is implanted subcutaneously.
Leads provide the electrical connection between the pulse generator and the heart tissue which is to be excited. Since the lead is disposed in body fluid and is disposed within the patient for long periods of time, electrical insulation of the lead is important. One approach to providing electrical insulation is to provide a lead body of silicone. However, the silicone provides limited abrasion resistance. During placement of the lead, the tip of the lead and lead body travels intravenously through veins and the heart. While traveling through the veins, the lead body may experience resistance from the lead body rubbing against the wall of the vein or the helix at the tip of the lead may snag or attach to the side wall of the vein. This is undesirable as it may cause damage or other complications to a patient during implantation of the lead. In addition, for leads having multiple legs or when multiple leads are implanted, it is important that the lead bodies do not adhere to one another after placement of the lead within the patient.
Accordingly, there is a need for a lead which allows for positioning through a passage, such as a vein or artery, without substantial resistance from the wall of the vein or artery. What is also needed is a lead with improved abrasion resistance, which also provides electrical insulation for the lead.
A lead has a flexible lead body which extends from a proximal end to a distal end. The distal end of the lead body includes one or more legs. Optionally, the lead is coupled with a pulse generator. The lead body has a conductor coupled with an electrode. At least a portion of the flexible lead body includes polymers of vinylidene fluoride, or polymers of vinylidene fluoride and silicone rubber in multiple layers. Optionally, the polymers of vinylidene fluoride comprises a homopolymer, a copolymer, or a terpolymer. The poly (vinylidene fluoride), in one embodiment, comprises a heat shrunk layer of insulation.
A method includes increasing the abrasion resistance of a lead assembly having a flexible lead body and at least one electrode. The method includes applying a layer of poly vinylidene fluoride on the flexible lead body. Optionally, applying the layer of poly vinylidene fluoride includes heat shrinking a tube of poly vinylidene fluoride on the flexible lead body. In another embodiment, the method further includes applying a second layer of insulation, wherein the second layer of insulation is silicone rubber.
The lead and method provides abrasion resistance, lubricity, and resistance to body fluids. In addition poly vinylidene fluoride has a heat shrink temperature which does not damage the lead and does not degrade a layer of silicone on the lead.
The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.
FIG. 2 illustrates a system for monitoring and stimulating the heart constructed in accordance with one embodiment.
FIG. 3 is a cross-section of a lead assembly constructed in accordance with one embodiment.
FIG. 1 illustrates a single-pass lead 100 for delivering electrical pulses to stimulate a heart 101 and/or for receiving electrical pulses to monitor the heart 101. The lead 100 extends from a distal end 102 to a proximal end 104, and has an intermediate portion 105 therebetween. The distal end 102 is adapted for implantation within the heart of a patient, the proximal end 104 has a terminal connector which electrically connects the various electrodes and conductors within the lead body to a pulse generator and signal sensor 109. The pulse generator and signal senor 109 contains electronics to sense various electrical signals of the heart and also produce current pulses for delivery to the heart 101. As shown in FIG. 2, the lead 100 optionally includes a first leg 160 and a second leg 162 at the distal end 102 of the lead 100.
The lead 100 includes a lead body 115, an elongate conductor 116 (FIGS. 3 and 4) contained within the lead body 11 5, and at least one electrode 120 coupled with the lead 100. The at least one electrode 120 is electrically coupled with the elongate conductor 116 (FIGS. 3 and 4). The lead body 115 is covered with a biocompatible insulating material 222 (FIGS. 3 and 4), discussed further below. The elongate conductor 116 defines a lumen therein and thereby is adapted to receive a stiffening stylet that extends through the length of the lead 100. The stylet is used to stiffen the lead 100, and is manipulated to facilitate the insertion of the lead 100 into and through a vein and through an intracardiac valve to advance the distal end 102 of the lead 100 into, for example, the ventricle of the heart 101. A stylet knob is coupled with the stylet for rotating the stylet, advancing the conductor into tissue of the heart, and for manipulating the lead 100.
In one embodiment, the at least one electrode 120 is disposed proximate to the distal end 102 of the lead 100. The distal end 102 of the lead 100, in one embodiment, is disposed within a ventricle of a heart, and the at least one electrode 120 delivers ventricular therapy. The at least one electrode 120 comprises, in one embodiment, a pacing and/or sensing electrode. In yet another embodiment, the at least one electrode 120 is disposed at the intermediate portion 105 between the distal end 102 and the proximal end 104 of the lead 100. In another embodiment, a plurality of electrodes 132 are disposed on the lead 100.
FIG. 2 illustrates a cross-section of the leads shown in FIGS. 1 and 2, including the lead 100, and/or the lead and the pulse generator and signal sensor 109. The lead 100 is used to chronically stimulate the heart 101, such that the lead 100 is implanted on or about the heart 101 for long periods of time. As mentioned above, the lead body 115 includes a covering of insulation 220. The insulation 220, in one embodiment, comprises a polymer of vinylidene fluoride. Optionally, the vinylidene fluoride comprises a homopolymer. Alternatively, the vinylidene fluoride comprises a copolymer. In yet another alternative, the vinylidene fluoride comprises a terpolymer.
The insulation 220 includes a first layer of insulation 222, as shown in FIG. 3. Optionally, the insulation 220 comprises vinylidene fluoride which is heat shrunk on to the flexible lead body 115. In another alternative, a second layer of insulation 224, as shown in FIG. 4, is disposed over the first layer of insulation 222. The second layer of insulation 224, optionally comprises a polymer of vinylidene fluoride, and the first layer of insulation 222 optionally comprises a different layer of material, for instance, silicone rubber. It should be noted that the vinylidene fluoride comprises the variety of vinylidene fluoride as discussed above.
Advantageously, the above described lead provides abrasion resistance, lubricity, and resistance to body fluids. In addition vinylidene fluoride has a heat shrink temperature which does not damage the lead and does not degrade a layer of silicone on the lead.
It is to be understood that the above description is intended to be illustrative, and not restrictive. It should be noted that features of the various above-described embodiments may be interchanged to form additional combinations. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS5324321 *Dec 22, 1992Jun 28, 1994Medtronic, Inc.Medical electrical lead having sigmoidal conductors and non-circular lumensUS5539052 *Feb 3, 1995Jul 23, 1996Surprenant Cable Corp.Crosslinked thermoplastic elastomersUS5628774Apr 27, 1995May 13, 1997Incontrol, Inc.Cardiac lead with composite insulating structureUS5796044 *Feb 10, 1997Aug 18, 1998Medtronic, Inc.Coiled wire conductor insulation for biomedical leadUS5947964 *Jul 3, 1997Sep 7, 1999Neothermia CorporationMethods and apparatus for therapeutic cauterization of predetermined volumes of biological tissueUS5968087 *Dec 15, 1997Oct 19, 1999Medtronic, Inc.Multi-component lead body for medical electrical leadsUS6141594 *Jul 22, 1998Oct 31, 2000Cardiac Pacemakers, Inc.Single pass lead and system with active and passive fixation elements* Cited by examinerNon-Patent CitationsReference1"High Performance Custom Coating and Surface Modification Services", Materials and Techniques information published by Vitek Research Corporation at http://www.ncia,net/vitek/material.htm., pp. 1-9 (1996).2Kleinhanz, P., et al., "Comparing Insulating Materials for Electrosurgical Instruments", Medical Device & Diagnostic Industry, vol. 18, No. 2, pp. 82, 84-86 and 88 (Feb. 1996).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS6606522May 30, 2001Aug 12, 2003Cardiac Pacemakers, Inc.Torque mechanism and method for endocardial leadsUS6701191 *May 30, 2001Mar 2, 2004Cardiac Pacemakers, Inc.Lead having composite tubingUS7257449May 30, 2001Aug 14, 2007Cardiac Pacemakers, Inc.Extendable/retractable lead having downsized lead bodyUS7337009Nov 20, 2003Feb 26, 2008Cardiac Pacemakers, Inc.Lead having composite tubingUS7366573 *Jun 10, 2005Apr 29, 2008Cardiac Pacemakers, Inc.Polymer lead covering with varied material propertiesUS7835802Mar 11, 2008Nov 16, 2010Cardiac Pacemakers, Inc.Polymer lead covering with varied material propertiesUS8046084Jul 19, 2007Oct 25, 2011Cardiac Pacemakers, Inc.Extendable/retractable lead having downsized lead bodyUS8055352Oct 13, 2010Nov 8, 2011Cardiac Pacemakers, Inc.Polymer lead covering with varied material propertiesUS8492512Aug 30, 2011Jul 23, 2013Surmodics Pharmaceuticals, Inc.Process for reducing moisture in a biodegradable implant deviceUS8920921Aug 30, 2011Dec 30, 2014Surmodics Pharmaceuticals, Inc.Terpolymer blends and their use as pressure-sensitive adhesivesUS8951546Dec 21, 2009Feb 10, 2015Surmodics Pharmaceuticals, Inc.Flexible implantable composites and implants comprising sameUS8974808Dec 21, 2009Mar 10, 2015Surmodics, Inc.Elastic implantable composites and implants comprising sameUS9090737Nov 12, 2008Jul 28, 2015Surmodics, Inc.Viscous terpolymers as drug delivery platformUS9415197Dec 21, 2009Aug 16, 2016Surmodics, Inc.Implantable suction cup composites and implants comprising sameUS9416221Aug 30, 2011Aug 16, 2016Surmodics, Inc.Biodegradable terpolymers and terpolymer blends as pressure-sensitive adhesivesUS20020183822 *May 30, 2001Dec 5, 2002Bodner Jeffrey P.Extendable/retractable lead having downsized lead bodyUS20040230277 *Nov 20, 2003Nov 18, 2004Cardiac Pacemakers, Inc.Lead having composite tubingUS20060282144 *Jun 10, 2005Dec 14, 2006Cardiac Pacemakers, Inc.Polymer lead covering with varied material propertiesUS20080011504 *Jul 19, 2007Jan 17, 2008Cardiac Pacemakers, Inc.Extendable/retractable lead having downsized lead bodyUS20080132984 *Feb 5, 2008Jun 5, 2008Cardiac Pacemakers, Inc.Lead having composite insulative coatingUS20080161871 *Mar 11, 2008Jul 3, 2008Cardiac Pacemakers, Inc.Polymer lead covering with varied material propertiesUS20090124535 *Nov 12, 2008May 14, 2009Peter MarklandViscous terpolymers as drug delivery platformUS20100158978 *Dec 21, 2009Jun 24, 2010Peter MarklandBioactive spray coating compositions and methods of making and uses thereofUS20100160891 *Dec 21, 2009Jun 24, 2010Tipton Arthur JElastic implantable composites and implants comprising sameUS20100168807 *Dec 22, 2009Jul 1, 2010Burton Kevin WBioactive terpolymer compositions and methods of making and using sameUS20110004285 *Dec 29, 2009Jan 6, 2011Medtronic, Inc.System and method for cardiac leadUS20110004286 *Dec 29, 2009Jan 6, 2011Medtronic, Inc.System and method for cardiac leadUS20110030872 *Oct 13, 2010Feb 10, 2011Knapp Christopher PPolymer lead covering with varied material propertiesUS20110129422 *Feb 8, 2011Jun 2, 2011Brookwood PharmaceuticalsViscous Terpolymers as Drug Delivery Platform* Cited by examinerClassifications U.S. Classification607/122, 607/116, 600/374International ClassificationA61N1/05Cooperative ClassificationA61N1/056European ClassificationA61N1/05NLegal EventsDateCodeEventDescriptionFeb 28, 2000ASAssignmentOwner name: CARDIAC PACEMAKERS, INC., MINNESOTAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SKINNER, DWIGHT;CHASTAIN, STUART R.;KRISHNAN, MOHAN;AND OTHERS;REEL/FRAME:010617/0530Effective date: 20000222May 5, 2006FPAYFee paymentYear of fee payment: 4Apr 29, 2010FPAYFee paymentYear of fee payment: 8Jun 13, 2014REMIMaintenance fee reminder mailedNov 5, 2014LAPSLapse for failure to pay maintenance feesDec 23, 2014FPExpired due to failure to pay maintenance feeEffective date: 20141105RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services