High impedance active fixation electrode of an electrical medical lead

Electrical medical leads having active fixation electrodes, particularly helix electrodes intended to be screwed into body tissue, e.g., the heart, are disclosed having selectively applied insulation to optimize exposed electrode surface area and dispose the exposed electrode surface area toward tissue that is less traumatized by injury caused by screwing in the fixation helix. In a preferred fabrication method, an outer helical surface is masked by contact with a masking tube while a dielectric coating is applied to the inner helical surface of the coil turns of the helix, and the masking tube is removed when the dielectric coating has set. In one variation, at least one aperture is formed through the masking tube sidewall exposing an area of the outer helical surface thereby interrupting the uninsulated outer helical electrode.

TECHNICAL FIELD

The present invention relates to electrical medical leads having active fixation electrodes, particularly helix electrodes intended to be screwed into body tissue, e.g., the heart, having selectively applied insulation to optimize exposed electrode surface area and dispose the exposed electrode surface area toward tissue that is less traumatized by injury caused by screwing in the fixation helix.

BACKGROUND

Implantable medical electrical stimulation and/or sensing leads (electrical medical leads) are well known in the fields of tissue stimulation and monitoring, including cardiac pacing and cardioversion/defibrillation, and in other fields of electrical stimulation or monitoring of electrical signals or other physiologic parameters. In the field of cardiac stimulation and monitoring, the electrodes of epicardial or endocardial cardiac leads are affixed against the epicardium or endocardium, respectively, or inserted therethrough into the underlying myocardium of the heart wall.

Epicardial or myocardial cardiac leads, or simply epicardial leads, are implanted by exposure of the epicardium of the heart typically through a limited thorocotomy or a more extensive surgical exposure made to perform other corrective procedures. Endocardial cardiac leads, or simply endocardial leads, are implanted through a transvenous route to locate one or more sensing and/or stimulation electrode along or at the distal end of the lead in a desired implantation site in a chamber of the heart or a blood vessel of the heart. It is necessary to accurately position the electrode surface against the endocardium or within the myocardium or coronary vessel at the implantation site.

A passive or active fixation mechanism is typically incorporated into the distal end of permanent cardiac leads and is deployed at the implantation site to maintain the distal end electrode in contact with the endocardium or within the myocardium. Considerable effort has been undertaken to develop passive and active fixation mechanisms that are simple to use and are reliable in maintaining the distal electrodes in position.

Active fixation mechanisms are designed to penetrate the epicardial or endocardial surface and lodge in the myocardium without perforating all the way through the myocardium. The most widely used active fixation mechanism employs a helix, which typically also constitutes a pace/sense electrode. Typically, a mechanism is used to shield the sharpened tip of the helix during the transvenous advancement into the desired heart chamber or coronary vessel or to the epicardial surface. In one approach, a retraction mechanism that retracts the helix into a distal cavity of the lead body as shown in U.S. Pat. Nos. 5,837,006 and 6,298,272, for example, is employed. In another approach, a shroud, e.g., a plug of dissolvable biocompatible material as disclosed in U.S. Pat. No. 5,531,783, for example, is applied over and between the coil turns of the helix. In still another approach, the lead is introduced through the sheath of a guide catheter, as disclosed in U.S. Pat. No. 6,408,214, for example, that is advanced to the implantation site. The helix is advanced from the sheath or out of the lead body or the plug dissolves when the desired implantation site is reached. In one manner or another, the helix is adapted to be rotated by some means from the proximal end of the lead body outside the patient's body in order to screw the turns of the helix into the myocardium and permanently fix the pace/sense electrode.

Over the last 30 years, it has become possible to reduce endocardial lead body diameters from 10 to 12 French (3.3 to 4.0 mm) down to 2 French (0.66 mm) presently through a variety of improvements in conductor and insulator materials and manufacturing techniques. The lead bodies of such small diameter, 2 French, endocardial leads are formed without a lumen that accommodates use of a stiffening stylet to assist in implantation.

Such a small diameter endocardial lead is formed with an active fixation helix that extends distally and axially in alignment with the lead body to a sharpened distal tip and that has a helix diameter substantially equal to the lead body diameter. The fixation helix does not necessarily increase the overall diameter of the endocardial lead, and fixation is relatively robust once the helix is screwed into the myocardium. Typically, but not necessarily, the fixation helix is electrically connected to a lead conductor and functions as a pace/sense electrode. In some cases, the lead body encloses one or more helical coiled or stranded wire conductor and lacks a lumen.

When the fixation helix is used as a pace/sense electrode, the surface area of the fixation helix must be controlled within a range that historically has been between 6-10 mm2, typically 8 mm2. The fixation helix outer diameter approximates the lead body diameter, and the fixation helix typically has more than one coil turn. More recent, small diameter fixation helices have surface areas in the range of 2.0 mm2to 5.0 mm2typically 4.0 mm2. The number of turns and length of the fixation helix is selected to avoid perforation through the heart wall. The exposed electrode surface must be within the myocardium rather than exposed outside the heart or inside a heart chamber.

Consequently, it is conventional to coat a part or parts of the fixation helix with electrical insulation to control the exposed surface area and to ensure that the exposed portion of the helix remains within the myocardium when the helix is properly screwed in. See, for example, U.S. Pat. Nos. 4,000,745, 4,010,758, 5,143,090, and 6,501,994 and U.S. Patent Application Publication Nos. 2003/0060868 and 2003/0163184. Electrically insulating coatings are also applied to portions of barbed electrodes of epicardial leads as shown, for example in commonly assigned U.S. Pat. No. 4,313,448. Electrical insulation of a fixation helix that is not employed as a pace/sense electrode is shown, for example, in U.S. Pat. No. 4,662,382. Various forms of selective electrical insulation of other shapes of pace/sense electrodes are shown in U.S. Pat. Nos. 4,026,303 and 6,526,321 and in EP Publication No. 0 042 551.

The dielectric, biocompatible, insulating coatings of choice have included silicone rubber and non-thrombogenic compounds such as Parylene C™ parylene, and various polyurethanes, polyacrylates (including polymethacrylates), polyesters, polyamides, polyethers, polysiloxanes, polyepoxide resins and the like. Cross-linked polymers within these classes may be preferred for their resistance to breakdown and their physical durability. Parylene coatings on the surfaces of implantable medical devices have been widely accepted, and the deposition of a parylene coating on a pace/sense electrode can be readily effected using a parylene vacuum deposition system that delivers poly-paraxylylene into a vacuum chamber containing the targeted electrode. The portions of the deposited parylene coating can be etched away as disclosed in the above-referenced '321 patent to expose the pace/sense electrode surface.

The ideal electrode impedance for chronic pacing across the electrode-tissue interface is in the range of 800 to 1,000 ohms. For example, the impedances reported in the above-referenced '994 patent are about 800 ohms measured during chronic implantation. The perforation of the myocardium by the fixation helix causes inflammation and cell death, particularly of myocardial cells between the turns of the helix and within the helix lumen, and impedance rises for a time following implantation to about 1200 ohms, for example, before falling to the chronic impedance level. Cell death and substitution of scar tissue for excitable myocardial cells is responsible for the observed impedance changes. Steroid eluting coatings and devices are commonly incorporated into the distal end of the lead body to counter post-implantation impedance rise as described in the above-referenced '994 patent and in U.S. Pat. No. 5,324,325, for example.

Pace/sense electrodes are typically formed of platinum or platinum iridium alloys that are bio-compatible and bio-stable during chronic implantation and delivery of pacing pulses. Consequently, fixation helices used as pace/sense electrodes are formed of platinum or platinum iridium wire wound into the helical shape to have one or more coil turn terminating in a sharpened tip. It is also common practice to surface treat or etch the electrode surface area of helical screw-in electrodes or to coat the electrode surface area with platinum black or a platinum metal oxide to create a surface texture that enhances the characteristics of the tissue-electrode interface to decrease post pulse delivery polarization and stabilizes impedance changes, as disclosed in U.S. Pat. No. 4,762,136, for example.

It is not convenient to surface treat the fixation helix, coat the surface treated helix with a dielectric insulating layer, and then selectively etch away the insulating layer to expose the pace/sense electrode surface as suggested in the above-referenced '321 patent, since the etching may damage an electrode coating or surface treatment.

Moreover, the selective insulation techniques and resulting electrode surface areas on pace/sense screw-in electrodes disclosed in the prior art fail to address the injury and cell death occurring within the lumen of the fixation helix.

SUMMARY

The methods of fabrication of fixation helices of the present invention address these issues and provides a fixation helix having selectively applied insulation to optimize exposed electrode surface area and dispose the exposed electrode surface area toward tissue that is less traumatized by injury caused by screwing the fixation helix into the tissue. The methods of the present invention may be applied to any of the above-described helices of endocardial and epicardial leads.

A preferred embodiment of a fixation helix of the present invention has at least one turn, wherein an inner spiral or helical surface is electrically insulated and an outer spiral or helical surface is exposed to function as a pace/sense electrode exposed to myocardial cells surrounding the turns of the helix.

In a preferred fabrication method, the outer helical surface is masked when a dielectric coating is applied to the inner helical surface, and the masking is removed when the dielectric coating has set. In one approach, the helix is fitted into the lumen of a resilient masking tube such that the lumen surface bears snugly against the outer helical surface of the helix. The dielectric material is directed into the coaxially aligned helix lumen and tube lumen and forms a dielectric coating on the inner helical surface of the coil turns of the helix. The resilient masking tube is then removed, as by slitting through the tubing sidewall and peeling the tubing from the helix to expose the uncoated outer helical surface.

In one variation, at least one aperture is formed through the masking tube side wall exposing an area of the outer helical surface. The uninsulated outer helical electrode is thereby rendered non-continuous through its length.

Advantageously, the entire surface of the fixation helix may be surface treated in any of the conventional ways or coated with any of the conventional materials for optimizing impedance, reducing polarization, reducing inflammation, and enhancing the electrode-tissue interface before the helix is fitted into the lumen of the masking tube. The surface treatment or coating is not damaged by contact with the masking tube during deposition of the dielectric layer. Alternatively, the uninsulated outer helical electrode surface may be treated or coated following deposition of the insulating material.

Furthermore, the entire surface of the fixation helix or the insulated surface of the fixation helix may be coated with or incorporate a steroid.

The exposed outer helical electrode is directed toward viable, excitable myocardial cells, and battery energy can be conserved due to as pacing energy is directed away from traumatized cells within the helix lumen and between the spiral turns. The exposed electrode surface area can be substantially reduced even for a small diameter fixation helix to achieve an optimal impedance due to the outward orientation of the outer helical electrode surface that avoids delivering stimulation energy to traumatized tissue or myocardial cells within the helix lumen or between the adjacent facing surfaces of the coil turns.

This summary of the invention and the advantages and features thereof have been presented here simply to point out some of the ways that the invention overcomes difficulties presented in the prior art and to distinguish the invention from the prior art and is not intended to operate in any manner as a limitation on the interpretation of claims that are presented initially in the patent application and that are ultimately granted.

The drawing figures are not necessarily to scale.

DETAILED DESCRIPTION

In the following detailed description, references are made to illustrative embodiments for carrying out the invention. It is understood that other embodiments may be utilized without departing from the scope of the invention. The invention and its preferred embodiments may be employed in unipolar, bipolar or multi-polar, endocardial, cardiac pacing leads, cardioversion/defibrillation leads or monitoring leads having at least one pace/sense electrode formed as part of the distal fixation helix that is to be screwed into the myocardium. It will be understood that other sensors for sensing a physiologic parameter may be incorporated into the lead body.

An insulated electrical conductor extending proximally through the lead body to connector element of a lead proximal end connector assembly is coupled to each such pace/sense electrode, sense electrode, cardioversion/defibrillation electrode and sensor. The proximal connector assembly is adapted to be coupled to the connector assembly of an external medical device, including an external pacemaker or monitor, or an implantable medical device, including an implantable pulse generator (IPG) for pacing, cardioversion/defibrillation (or both) or an implantable monitor.

The methods of the present invention are particularly useful in optimizing electrode surface area on the distal fixation helix to provide optimal pacing and sensing impedance and to dispose the exposed electrode surface area toward myocardial tissue that is less traumatized by injury caused by screwing the fixation helix into the myocardium.

The cardiac lead of the preferred embodiment of the invention can be introduced in a variety of ways to the epicardial or endocardial surface of the heart or into a coronary blood vessel so that the distal fixation helix can be screwed into the myocardium. Epicardial implantation sites, particularly left ventricular sites can be accessed in a variety of ways involving surgical creation of a thoracic passage and use of an introducer and guide catheter. Endocardial implantation sites include the apex of the right ventricle, the atrial appendage or at other sited of the right atrium, and into the coronary sinus.

For convenience, exemplary endocardial implantation sites are depicted inFIG. 1, particularly sites within the coronary sinus and vessels branching therefrom.FIG. 1is a schematic diagram of a heart6from an anterior perspective illustrating a coronary venous system about an epicardial surface, including dashed lines depicting a portion of coronary venous system on an opposite, posterior surface of the heart6.FIG. 1also illustrates a pathway, defined by arrow ‘A’, which may be followed in order to place a cardiac lead within CS4, extending from a venous access site (not shown) through the superior vena cava (SVC)1into the right atrium (RA)2of heart6and from the RA2into the CS4through a coronary sinus ostium (CS Os)3.

As illustrated inFIG. 1, the coronary venous system of a heart6includes the CS4and vessels branching therefrom including the middle cardiac vein (MCV)13, the posterior cardiac vein (PCV)12, the posterior-lateral cardiac vein (PLV)11, the great cardiac vein (GCV)9, and the lateral cardiac vein (LCV)10all branching away from the CS4. Generally speaking, the distal portion of the CS4and the branching vessels including at least portions of the MCV13, PCV12, the PLV11, the GCV9, and the LCV10overlie the or are embedded within the epicardium that defines outer surface of the heart6and encases heart muscle or myocardium. Portions of the epicardium are spaced from a surrounding pericardial sac or pericardium (not shown), whereby a pericardial space surrounds the spaced epicardium of heart6. Thus, the vessel walls of the distal portion of the CS4and the branching vessels including at least portions of the MCV13, PCV12, the PLV11, the GCV9, and the LCV10are partially exposed to the pericardial space or adhered to the pericardium and are partially embedded against the underlying myocardium. For convenience of terminology, the vessel walls that are disposed toward the pericardium are referred to as disposed “away from the heart”, whereas the vessel walls that are disposed toward the myocardium are referred to as disposed “toward the heart”.

In patients suffering from heart failure, a CS lead of the types described above is advanced through the pathway “A” extending through the SVC1and RA2into the CS4to dispose one or a pair of distal pace/sense electrodes at an LV site(s) within one of the vessels branching from the CS4. An RV lead is advanced through the SVC1, the RA2, the tricuspid valve, and the distal pace/sense electrode(s) is affixed at an RV pace/sense site(s) of the RV8, e.g., in the RV apex or along the septum separating the RV and LV chambers. The RV lead can take any of the functions known in the art preferably having an active or passive fixation mechanism.

The proximal connectors of the CS lead and the RV lead are coupled to a connector header of a pacing IPG or an ICD IPG (not shown) implanted subcutaneously. The IPG is capable of sensing and processing cardiac signals detected at the pace/sense site(s) to provide synchronized RV and LV pacing at the pace/sense sites as needed. The pacing and sensing functions of such an IPG that provides synchronous activation of the RV8and LV7in order to improve the hemodynamic output of the heart6are disclosed in commonly assigned U.S. Pat. No. 5,902,324, for example, and are embodied in the MEDTRONIC® InSync Marquis™ ICD IPG, for example.

Hemodynamic output is enhanced when the CS pace/sense electrode(s) site is selected within a late activated region of LV7. Late activated regions of the LV7are found within the myocardium underlying the PLV11, the LCV10, the GCV9, or the CS4near a junction with the GCV9. Moreover, pacing and sensing functions are optimized when the pace/sense electrode(s) are disposed in intimate contact with excitable myocardial tissue. Thus, the CS pace/sense electrode(s) are to be advanced through the pathway “A” to the site of a selected late activated region and affixed so that the CS pace/sense electrodes are disposed toward the heart6and not disposed away from the heart6. The fixation is accomplished by use of an active fixation helix that is directed toward the heart6and screwed through the vessel wall and into the myocardium.

The lead body of an endocardial lead introduced to a fixation site within the RA2, the RV8, and the CS4, and vessels branching therefrom, typically comprises one or more insulated conductive wire surrounded by an insulating outer sheath. Each conductive wire couples a proximal lead connector element with a distal stimulation and/or sensing electrode. Epicardial and endocardial leads having a single stimulation and/or sensing electrode at the lead distal end, a single conductor, and a single connector element are referred to as unipolar leads. Epicardial and endocardial leads having two or more stimulation and/or sensing electrodes at the lead distal end, two or more respective conductors, and two or more respective connector elements are referred to as bipolar leads or multi-polar leads, respectively.

A typical example of an active fixation cardiac lead20in which the present invention is implemented is schematically illustrated inFIG. 2. The cardiac lead20has an elongated lead body21that extends between a proximal connector22and a distal end24. A helical fixation element or helix25having a sharpened piercing tip251extends distally from lead body distal end24. The cardiac lead20can be configured as a unipolar or a bipolar or multi-polar lead for both endocardial or epicardial implantation. The distal fixation helix25of the cardiac lead can be affixed into the myocardium at any site of the RA2or the RV8, or any site accessed by advancement through pathway “A” into the CS or vessels branching therefrom. In addition, the cardiac lead20can be introduced to an epicardial implantation site in the manner described above, for example.

Pacing lead20is essentially iso-diametric along its length, with an outer diameter of lead body21and fixation helix25between approximately 1 French (0.33 mm) to 3 French (1.00 mm). Since lead body21does not include an inner lumen, the outer diameter of lead body21is reduced in this example. However, it will be understood that the features of the present invention can be employed with lead bodies that include one or more lumen.

In this example depicted inFIG. 2, lead body21is constructed of a stranded conductive or non-conductive filament cable28disposed within an inner sheath lumen of an inner sheath29, which in turn extends through the coil lumen of a coil27. The assembly of the coil27, inner sheath29, and cable28is fitted through an outer sheath lumen of an outer sheath26.

Coil27is formed of any bio-stable and biocompatible material that is sufficiently stiff to provide adequate torque transfer from proximal connector assembly22to fixation element25at distal end24of cardiac lead20. When coil27functions as a lead conductor, coil27is preferably formed of single or multiple wire filars made of MP35-N alloy, well known in the art, or any other bio-stable and biocompatible material that is capable of reliably conducting electrical current after having been subjected to numerous, repeated bending and torsional stresses.

Inner cable28is formed from synthetic filaments or conductive metallic wires, when inner cable functions as a lead conductor. The proximal and distal ends of inner cable28are coupled to connector pin23or within connector assembly22and fixation helix25, respectively, to provide tensile strength to lead body21.

Outer sheath26is formed of either a silicone rubber or polyurethane, well known in the art, or any other flexible, bio-stable and biocompatible, electrically insulating, polymer material. Inner sheath29is similarly formed of a bio-stable and biocompatible flexible polymer coating or tube that protects inner cable28from mechanical stresses or hydrolytic degradation and electrically insulates inner cable28from contact with wire coil27. Inner sheath29can be formed of flexible, bio-stable and biocompatible electrically insulating materials known in the art, including silicone rubber compounds, polyurethanes, and fluoropolymers.

In both unipolar and bipolar cardiac lead embodiments, the proximal connector assembly22includes a connector pin23that is typically electrically connected with the distal fixation helix25when the distal fixation helix25functions as a pace/sense electrode. In a bipolar cardiac lead embodiment, the proximal connector assembly22includes a connector ring32(shown with dashed lines) that is electrically coupled to a ring-shaped pace/sense electrode30(shown with dashed lines) supported by outer sheath26proximal to fixation helix25. The connector assembly22is shaped to be inserted into a bore of a connector block of the connector header of an IPG as described above to make an electrical connection between the distal pace/sense electrode(s) and IPG sensing and/or pacing pulse generating circuitry. The fixation helix25is adapted to be screwed into the myocardium, as described below, by rotation of lead body21from the proximal connector assembly22when piercing tip251is advanced to and oriented toward a fixation site.

In a unipolar embodiment of cardiac lead20, the inner cable28is nonconductive, a proximal end of coil27is coupled to connector pin23, and a distal end of coil27is coupled to the proximal end of fixation helix25. The proximal and distal ends of coil27are welded or crimped to the connector pin23and fixation helix25, respectively, using common welding or crimping techniques known in the art. The proximal and distal ends of inner cable28are crimped to the connector pin23or connector assembly22and fixation helix25, respectively, using common welding or crimping techniques known in the art.

In an alternate unipolar embodiment wherein the inner cable is nonconductive, helix fixation element25simply provides fixation and does not function as a pace/sense electrode. The proximal end of coil27is coupled to connector pin23, and the distal end of coil27is coupled to the ring-shaped pace/sense electrode30incorporated coaxially about a distal portion of lead body21. The spacing31between ring-shaped pace/sense electrode30and fixation helix25is less than approximately 0.02 inches in order to locate ring-shaped pace/sense electrode30close enough to a fixation site for tissue contact when fixation helix25is fixed into the myocardium.

In a further alternate unipolar embodiment of cardiac lead20, inner cable28is electrically conductive, and the proximal and distal cable ends are electrically coupled by crimping or welding or other known techniques to connector pin23and helix fixation element25, respectively. Inner sheath29electrically insulates inner cable28from coil27, which acts only as a structural element to provide torsional stiffness to lead body21. Alternatively, the proximal and distal ends of the conductive inner cable28and the wire coil27can be electrically connected together to provide a redundant unipolar lead conductors. Conductive inner cable28is preferably formed from wire strands or filaments made of MP35-N alloy, well known in the art, or any other bio-stable and biocompatible material that is capable of reliably conducting electrical current after having been subjected to numerous, repeated bending and torsional stresses.

In a bipolar embodiment of cardiac lead20, both coil27and inner cable28are lead conductors as described above, that are electrically insulated from one another by inner sheath29. The ring-shaped pace/sense electrode30is preferably formed of a platinum alloy but other materials may also be used, including but not limited to such materials as palladium, titanium, tantalum, rhodium, iridium, carbon, vitreous carbon and alloys, oxides and nitrides of such metals or other conductive or even semi-conductive materials. Of course, some materials are incompatible with others and may not be effectively used together. The limitations of specific materials for use with others are well known in the art. The proximal and distal ends of coil27are electrically and mechanically coupled by crimping or welding to the connector ring32and the ring-shaped pace/sense electrode30, respectively. The proximal and distal ends of the inner cable28are electrically and mechanically coupled by crimping or welding to connector pin23and distal fixation helix25, respectively.

The spacing31between ring-shaped pace/sense electrode30and fixation helix25is between approximately 0.2 inches and 0.4 inches, a range well known in the pacing art for inter-electrode bipolar pace/sense electrode spacing.

The exemplary active fixation cardiac lead20can also be formed having an elongated cardioversion/defibrillation (C/D) electrode extending proximally a predetermined distance along the outer sheath21from a C/D electrode distal end located proximal to distal lead end24. The proximal and distal ends of the wire coil27would be electrically and mechanically coupled to the connector ring32and the elongated C/D electrode, respectively. The proximal and distal ends of the inner cable28would be electrically and mechanically coupled by crimping or welding to connector pin23and distal fixation helix25, respectively.

A means for steroid elution may be incorporated into any of the aforementioned embodiments of the exemplary active fixation cardiac lead20near distal end24to counter post-implantation impedance rise. Such steroid elution means may take the form of a monolithic controlled release device (MCRD), preferably constructed from silicone rubber and loaded with a derivative of dexamethasone, such as the water-soluble steroid dexamethasone sodium phosphate. MCRD construction and methods of fabrication are found in commonly assigned U.S. Pat. Nos. 4,506,680, 4,577,642, 4,606,118, 4,711,251, and 5,282,844. Alternatively a steroid coating containing a no more than sparingly water-soluble steroid such as beclomethasone diproprionate or dexamethasone acetate may be applied to surfaces of ring-shaped pace/sense electrode30and/or fixation helix25. A steroid coating composition and method of application is found in commonly assigned U.S. Pat. No. 5,987,746. The steroid coating may be applied directly to surfaces or portions of surfaces preserving structural integrity of ring-shaped pace/sense electrode30and/or fixation helix25and taking up less space than an MCRD.

Such an exemplary active fixation cardiac lead20can be employed advantageously as a CS lead through the use of a guide catheter advanced through the pathway “A” ofFIG. 1to locate the fixation helix25at a fixation site in the coronary vasculature and to aim the helix tip251toward the heart before the connector assembly22is rotated to screw the fixation helix25through the vessel wall and into the myocardium.

In one approach shown, for example, in commonly assigned U.S. Pat. Nos. 5,246,014 and 6,408,214, the lead body is enclosed within the lumen of a further sheath or introducer, and the lead and introducer are disposed within the lumen of the guide catheter. The fixation helix is located within the catheter lumen during advancement of the lead distal end fixation helix through the transvenous pathway and heart chamber or coronary vessel to dispose the fixation helix near the implantation site.

Similar approaches have been undertaken to advance a fixation helix through minimally invasive surgical exposure of the pericardial sac to the epicardium of the heart and to screw the fixation helix into the myocardium. Early examples of such epicardial screw-in leads are shown, for example, in U.S. Pat. Nos. 3,472,234, 3,416,534, 3,737,579, 4,000,745, and 4,010,758, for example.

As shown inFIG. 2, the fixation helix25extends from a helix attachment end to a distal end terminating in a helix tip35shaped to penetrate body tissue when the helix25is screwed into body tissue to secure fixation to the implantation site. In accordance with the present invention, the fixation helix25is fabricated following the exemplary method depicted inFIGS. 3-8or the variation method depicted inFIGS. 9-12having a layer or coating42or142of insulating material covering at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen. After the coating42or142is applied, at least a portion of an uncoated outer helical surface of each coil turn comprises an uninsulated outer helical electrode40or140. The outer helical electrode40or140is disposed toward body tissue away from the helix lumen to function as a stimulation and sensing electrode upon implantation.

When fixation helix25functions as a pace/sense electrode of a pacing lead, as in any of the alternate endocardial and epicardial, unipolar and bipolar or multi-polar embodiments described above, fixation helix25is preferably formed of a platinum iridium alloy wire36shown inFIG. 3. It is understood that other biocompatible and bio-stable materials may also be used to form wire36, including but not limited to such materials as palladium, titanium, tantalum, rhodium, carbon, vitreous carbon and alloys, oxides and nitrides of such metals or other conductive or even semi-conductive materials well known in the art.

As shown inFIG. 3, the conductive wire36is preferably formed into a coil37comprising at least one coil turn (in this example, about three turns) wound to define a helix lumen within the inner diameter ID of the coil turns. The coil37extends from a support used during helix fabrication or a crimp tube50that will be used to attach the fixation helix25to the distal end of a conductor within the lead body. The coil37is wound about the crimp tube50, in this example, so that fixation helix attachment end is formed. The free end of the coil37is shaped to form the helix tip35that penetrates body tissue when the helix25is screwed into body tissue to secure fixation to the implantation site. Thus, a plurality of coil turns are depicted inFIG. 3that are space wound through a coil length CL in a constant pitch P and coil outer diameter OD defining the helix outer diameter and a coil inner diameter ID defining the helix lumen diameter. The space winding ensures that a space exists between facing surfaces of adjacent coil turns.

In one preferred embodiment, the wire36has a diameter of 0.25 mm, the pitch P is 1.0 mm, the coil OD is 1.6 mm, the coil ID is 1.1 mm and the coil length CL is 1.8 mm providing a helix surface area of 4.2 mm2. These dimensions can be varied to provide helix surface areas in the range of 2.0 mm2to 10.0 mm2. The present invention can be employed to selectively reduce the electrode surface area of a relatively large diameter fixation helix that provides robust fixation while advantageously orienting the electrode surface area toward viable, excitable body tissue at an implantation site. For example, the electrode surface area of a fixation helix having a total surface area of about 4.2 mm2can be selected to be between about 0.8 mm2to 2.1 mm2. About 10% to about 50% of the surface area helix surface area can be coated in accordance with the present invention.

The surface of the coil turns of the wire36is preferably surface treated or coated with a coating selected from the group consisting of titanium nitride, iridium oxide, platinum black, and carbon nanotubes to create a surface texture that enhances the characteristics of the tissue-electrode interface to decrease post pulse delivery polarization and stabilizes impedance changes. Advantageously, the coating or surface treatment can be done prior to application of the coating42of insulating material on the inner helical surface as described further below. Alternatively, the coating or surface treatment on the uninsulated outer helical electrode40can be done following application of the coating42of insulating material on the inner helical surface.

In the coating methods of the present invention, a layer of insulation is applied over at least a portion of an inner helical surface of each coil turn disposed toward the helix lumen, whereby at least a portion of an outer helical surface of each coil turn is uninsulated. The methods of applying the insulating material can be undertaken when the coil37is a separate piece part, that is, prior to attachment of the coil37to the lead body. This approach may be necessary when the fixation helix is adapted to be advanced from a cavity or chamber in the distal end of the lead body as described above. Alternatively, the methods of applying the insulating material can be undertaken after the coil37is affixed to the lead body to extend distally in the manner depicted in the fixed helix pacing lead depicted inFIG. 2. For convenience, it will be assumed that the methods of applying the insulating material are practiced to complete the fabrication of the fixation helix25as a piece part to be attached to the lead body and the distal end of an electrical conductor in the lead body.

Turning toFIGS. 5 and 6, a masking tube60having a tube wall62, a tube lumen64, a tube length at least as long as the coil37, and a masking tube lumen diameter correlated with the helix outer diameter OD is provided. An interference fit between the outer helical surface of the wire coil37and the masking tube lumen diameter is preferred. The masking tube60is preferably formed of a flexible polymer material, e.g., silicone rubber, that stretches to be receive the coil37. In this way, the coil37fits into the masking tube lumen64providing a masked outer helical surface44of each coil turn in intimate contact with the tube wall62and an inner helical surface46exposed to coating with the insulating material. Preferably, at least a portion of the adjacent coil turns that face one another are exposed within the masking tube lumen64.

Then, a polymer from among the group consisting of silicone rubber, parylene, polyurethane, polyacrylate, polymethacrylate, polyester, polyamide, polyether, polysiloxane, and polyepoxide is deposited upon the inner helical surface of each coil turn within the masking tube lumen64. For example, the assembly of the masking tube60, the coil37, and the crimp tube50are placed in a vacuum chamber of a parylene vacuum deposition system that delivers poly-paraxylylene into the vacuum chamber. A parylene coating is deposited upon the exposed inner helical surface46to form the inner helical insulating coating42.

The masking tube60is removed after the coating has solidified, and resulting fixation helix25shown inFIGS. 7 and 8now has an exposed, uninsulated outer helical electrode40in the area of the masked outer helical surface44and an insulating coating42over the exposed inner helical surface46. The fixation helix25is then assembled to the lead body in accordance with the methods employed to fabricate any particular electrical medical lead, e.g., the pacing lead20ofFIG. 2. As noted above, the process illustrated inFIGS. 3-8can be applied to a coil37that is already affixed to the distal end of a lead body, particularly if the coil37is not retractable into and extendable from a distal cavity of the lead body.

An alternative fabrication method is depicted inFIGS. 9 and 10that results in the fixation helix125depicted inFIGS. 11 and 12, having an interrupted outer helical electrode140. In this method, the masking tube160is formed having a tube wall162, a tube lumen164, a tube length at least as long as the coil37, and a masking tube lumen diameter correlated with the helix outer diameter OD is provided. An elongated aperture170is provided through the tube wall162that exposes one or more area or portion of the outer surface44. In the depicted example, the aperture170comprises a slit through the tube wall162extending substantially the length of the masking tube160. The masking tube160is dimensioned to provide an interference fit between the outer helical surface44of the wire coil37and the masking tube wall162. Again, the masking tube160is preferably formed of a flexible polymer material, e.g., silicone rubber, that stretches to be receive the coil37. In this way, the coil37fits into the masking tube lumen164providing a masked outer helical surface144of each coil turn in intimate contact with the tube wall162and an exposed inner helical surface146exposed to coating with the insulating material. In addition, a portion of each coil turn is exposed through the aperture170.

In this method, the parylene (or other polymer) coating is applied as described above into the masking tube lumen164and is also applied through the aperture170as shown inFIGS. 9 and 10. Again, the masking tube160is removed, and the resulting coating material extends around the circumference of the wire36of the coil turn crossing the aperture170in bands172,174,176.

As shown inFIGS. 11 and 12, the resulting fixation helix125has an outer helical electrode140that is interrupted by the insulating layer bands172,174,176. The number and surface area of bands172,174,176can be selectively controlled by selection of the length and width of the aperture170and by inclusion of further apertures around the circumference of the masking tube160. In this way, the resulting surface area of the outer helical electrode140can be tailored as found suitable for any intended implantation site.

Thus, following fixation in the myocardium, the exposed outer helical electrodes40and140are directed toward viable, excitable myocardial cells, and battery energy can be conserved due to as pacing energy is directed away from traumatized cells within the helix lumen and between the spiral coil turns. The exposed electrode surface area can be substantially reduced even for a small diameter fixation helix to achieve an optimal impedance due to the outward orientation of the outer helical electrode surface that avoids delivering stimulation energy to traumatized tissue or myocardial cells within the helix lumen or between the adjacent facing surfaces of the coil turns.

In preferred embodiments, the helix is formed of platinum metal or a platinum alloy and the uninsulated helical outer surface is coated with a coating selected the a coating selected from the group consisting of titanium nitride, iridium oxide, platinum black and carbon nanotubes.

Preferred embodiments of the present invention also include applying a steroid coating on fixation helices25and125that is applied during or following their formation as described above. In this regard, one preferable way of applying the steroid coating would be to molecularly bond the steroid with the insulating material, e.g., a silicone rubber or a polyurethane compound, that is deposited to form the coating. Alternatively, the steroid may be deposited onto the coating of insulating material before removing the masking tube60or160. Suitable steroids include derivatives of dexamethasone, such as the water-soluble steroid dexamethasone sodium phosphate, beclomethasone diproprionate, and dexamethasone acetate.

CONCLUSION

All patents and publications identified herein are incorporated herein by reference in their entireties.

While particular embodiments of the invention have been disclosed herein in detail, this has been done for the purposes of illustration only, and is not intended to limit the scope of the invention as defined in the claims that follow. It is to be understood that various substitutions, alterations, or modifications can be made to the disclosed embodiments without departing from the spirit and scope of the claims. The above described implementations are simply those presently preferred or contemplated by the inventors, and are not to be taken as limiting the present invention to the disclosed embodiments. It is therefore to be understood, that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described without actually departing from the spirit and scope of the present invention.