Construction of an MRI-safe tachycardia lead

Information

  • Patent Grant
  • 9682231
  • Patent Number
    9,682,231
  • Date Filed
    Wednesday, August 24, 2016
    8 years ago
  • Date Issued
    Tuesday, June 20, 2017
    7 years ago
Abstract
A medical device lead includes a tubular conductive element disposed over a lead body. The tubular conductive element includes at least one segment having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect at least one electrical property, e.g., electrical impedance, of the segment. The segment may form a shocking conductor of the medical device lead. The tubular conductive element may alternatively include proximal, intermediate and distal segments each having one or more kerfs formed radially therethrough, where the one or more kerfs in each of the proximal and intermediate segments are configured so that these segments each have a higher electrical impedance than the distal segment. A layer of insulative material is disposed over the proximal and intermediate segments, so that the proximal and intermediate segments of the tubular conductive element are operable to filter electromagnetic energy from an external source.
Description
TECHNICAL FIELD

The present invention relates to implantable medical devices and methods of manufacturing. More specifically, the invention relates to MRI compatible medical device lead and methods for manufacturing MRI compatible medical device lead.


BACKGROUND

Various medical devices are commonly used to treat patients suffering from chronic and/or disabling diseases such as chronic pain, Parkinson's disease, cardiac arrhythmias. Few of these medical devices are temporarily or permanently implanted within patient's body. Such medical devices include neurostimulators, cardiac pacemakers, or implantable cardioverter-defibrillators (ICDs) (collectively Implantable Medical Devices (IMDs)).


Generally, an IMD includes an implantable pulse generator and one or more conducting leads with electrodes used to conduct signals between the heart and the implantable pulse generator (IPG). Commonly, the IMD is implanted into the pectoral region of the patient's body. The leads extend from the IPG to stimulate one or more chambers of the heart. The leads are used to deliver therapy to the patient and each include one or more conducting cables, electrodes, and/or coils.


Further, in some scenarios, the patient with an IMD may need to undergo a Magnetic Resonance Imaging (MRI) scan. An MRI is a non-invasive imaging modality that utilizes a magnetic field and radio frequency (RF) pulses to generate images of various anatomical structures within a patient's body. Typically, an MRI scanner uses a magnet to create a strong static magnetic field to align the protons of hydrogen atoms in the patient's body. Then, the patient is exposed to RF pulses of electromagnetic energy causing the protons to spin about their axis. Once the RF pulses are removed, these protons tend to come back to their resting state aligned with the static magnetic field. The MRI scanner detects the signal generated by the spinning protons that is processed to create an image.


During the MRI scan, the RF pulses may be picked up by leads implanted within a patient's body. There is a need for improved lead design to minimize induced currents generated from MRI energy.


SUMMARY

In Example 1, a medical device lead, comprising a lead body, an electrical conductor and a tubular conductive element. The lead body includes a tubular member having a proximal end, a distal end, and a conductor lumen extending therebetween, wherein the tubular member is made of an electrically insulative material. The electrical conductor extends within the conductor lumen from the proximal end of the tubular member toward the distal end of the tubular member. The tubular conductive element is disposed over the tubular member of the lead body between the proximal and distal ends thereof. The tubular conductive element has one or more kerfs formed therethrough so as to affect an electrical property thereof, and wherein the electrical conductor is electrically coupled to the tubular conductive element.


In Example 2, the medical device lead of Example 1, wherein the one or more kerfs are formed in a helical pattern such that electrical current passing through the tubular conductive element travels along a helical path.


In Example 3, the medical device lead of either of Examples 1 or 2, wherein the one or more kerfs have a constant pitch.


In Example 4, the medical device lead of either of Examples 1 or 2, wherein the one or more kerfs have a variable pitch.


In Example 5, the medical device lead of any of Examples 1-4, wherein the first segment defines an electrode of the medical device lead.


In Example 6, the medical device lead of any of Examples 1-5, wherein the tubular conductive element includes a first segment and a second segment extending distally from the first segment, wherein the one or more kerfs are formed in each of the first and second segments so as to affect an electrical property of the first and second segments, wherein the first segment has a higher electrical impedance than the second segment.


In Example 7, the medical device lead of Example 6, further comprising a layer of insulative material disposed over the first segment.


In Example 8. the medical device lead of either of Examples 6 or 7, wherein the first segment is operable to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy.


In Example 9, the medical device lead of any of Examples 1-5, wherein the tubular conductive element includes first, second and third segments, the second segment extending distally from the first segment, and the third segment extending distally from the second segment, wherein the one or more kerfs are formed in each of the first, second and third segments, and wherein the one or more kerfs in each of the first and second segments are configured so that the first and second segments have a higher electrical impedance than the third segment.


In Example 10, the medical device lead of Example 9, further comprising a layer of insulative material disposed over the first and second segments of the tubular conductive element, so that the first and second segments of the tubular conductive element are operable to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy.


In Example 11, the medical device lead of Example 10, wherein an outer surface of the third segment of the tubular conductive element is uninsulated so that the third segment can be operable as a shocking electrode.


In Example 12, the medical device lead of any of Examples 9-11, wherein the electrical conductor is mechanically and electrically coupled to the tubular conductive element at a connection location disposed at a transition between the first and second segments of the tubular conductive element.


In Example 13, the medical device lead of any of Examples 9-11, wherein the first, second and third segments are formed from a single tube of conductive material.


In Example 14, the medical device lead of any of Examples 9-11, wherein one or more of the first, second and third segments are formed from separate tubes of conductive material and subsequently joined together by a weld joint.


In Example 15, the medical device lead of any of Examples 9-14, wherein the kerfs in the third segment include a series of kerfs each extending partially circumferentially about the tubular conductive element and distributed along the length of the third segment, wherein each kerf in the third segment is circumferentially offset from adjacent kerfs so as to cause electrical current to assume a non-linear flow path through the third segment.


In Example 16, a medical device lead, comprising a lead body, an electrical conductor and a tubular conductive element. The lead body includes a tubular member having a proximal end and a distal end and a conductor lumen extending therebetween, wherein the tubular member is made of an electrically insulative material. The electrical conductor extends within the conductor lumen from the proximal end of the tubular member toward the distal end of the tubular member. The tubular conductive element is disposed over the tubular member of the lead body between the proximal and distal ends thereof. The tubular conductive element includes a first segment, a second segment extending distally from the first segment, and a third segment extending distally from the second segment, each of the segments having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect an electrical impedance of the respective segment. The one or more kerfs in each of the first and second segments are configured so that the first and second segments have a higher electrical impedance than the third segment, and the electrical conductor is mechanically and electrically coupled to the tubular conductive element. A layer of insulative material is disposed over the first and second segments of the tubular conductive element. The first and second segments of the tubular conductive element are operable to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy. An outer surface of the third segment of the tubular conductive element is uninsulated so that the third segment can be operable as a shocking electrode.


In Example 17, the medical device lead of Example 16, wherein the electrical conductor is mechanically and electrically coupled to the tubular conductive element at a connection location disposed at a transition between the first and second segments of the tubular conductive element.


In Example 18, the medical device lead of either of Examples 16 or 17, wherein the kerfs in the first and second segments are formed in a helical pattern along a length thereof.


In Example 19, the medical device lead of any of Examples 16-18, wherein the kerfs in the first segment have a constant pitch along the length of the first segment.


In Example 20, the medical device lead of any of Examples 16-19, wherein the kerfs in the second segment have a constant pitch along the length of the second segment.


In Example 21, the medical device lead of any of Examples 16-18, wherein the kerfs in one or both of the first and second segments have a pitch that varies along the length of the respective segment.


In Example 22, the medical device lead of Example 21, wherein the pitch of the kerfs in one or both of the first and second segments decrease with distance from the connection location.


In Example 23, the medical device lead of any of Examples 16-22, wherein the kerfs in the third segment include a series of kerfs each extending partially circumferentially about the tubular conductive element and distributed along the length of the third segment, wherein each kerf in the third segment is circumferentially offset from adjacent kerfs so as to cause electrical current to assume a non-linear flow path through the third segment.


In Example 24, the medical device lead of any of Examples 16-23, wherein the first, second and third segments are formed from a single tube of conductive material.


In Example 25, the medical device lead of any of Examples 16-23, wherein one or more of the first, second and third segments are formed from separate tubes of conductive material and subsequently joined together by a weld joint.


In Example 26, a filtered electrode component for an implantable medical device lead, the filtered electrode component comprising a tubular conductive element including a first segment, a second segment extending distally from the first segment, and a third segment extending distally from the second segment, each of the segments having one or more kerfs formed radially therethrough in a predetermined configuration so as to affect an electrical impedance of the respective segment. The one or more kerfs in each of the first and second segments are configured so that the first and second segments have a higher electrical impedance than the third segment, and the tubular conductive element is configured to be mechanically and electrically coupled to an electrical conductor.


In Example 27, the filtered electrode component of Example 26, wherein the kerfs in the first and second segments are formed in a helical pattern along a length thereof.


In Example 28, the filtered electrode component of either of Examples 26 or 27, wherein the kerfs in one or both of the first and second segments has a constant pitch along the length of the respective segment.


In Example 29, the filtered electrode component of either of Examples 27 or 28, wherein the kerfs in one or both of the first and second segments have a pitch that varies along the length of the respective segment.


In Example 30, the filtered electrode component of Example 29, wherein the pitch of the kerfs in one or both of the first and second segments decreases with distance from the other of the first and second segments.


In Example 31, the filtered electrode component of any of Examples 26-30, wherein the kerfs in the third segment include a series of kerfs each extending partially circumferentially about the tubular conductive element and distributed along the length of the third segment, wherein each kerf in the third segment is circumferentially offset from adjacent kerfs so as to cause electrical current to assume a non-linear flow path through the third segment.


In Example 32, a method of forming an electrical component for a medical device lead, comprising mounting a tubular conductive element to a fixture, and cutting one or more kerfs radially through the tubular conductive element using a laser in one or more predetermined patterns configured so as to affect an electrical property of the tubular conductive element.


In Example 33, the method of Example 32, wherein cutting one or more kerfs includes cutting a first pattern of kerfs in a helical path along a first length of the tubular conductive element, and cutting a second pattern of kerfs in a non-helical pattern along a second length of the tubular conductive element.


In Example 34, the method of either of Examples 32 or 33, wherein cutting one or more kerfs includes cutting first, second and third patterns of kerfs to define first, second and third segments of the tubular conductive element, wherein the first and second patterns are helical patterns each having a variable pitch that decreases with distance from the other of the first and second patterns, and wherein the third pattern is a non-helical pattern, so that the first and second segments have an electrical impedance that is higher than an electrical impedance of the third segment.


In Example 35, the method of any of Examples 32-34, wherein the tubular conductive element is a first tubular conductive element, and wherein the method further comprises cutting one or more kerfs radially through a second tubular conductive element using a laser in one or more predetermined patterns configured so as to affect an electrical impedance of the second tubular conductive element, and mechanically and electrically joining the first and second tubular conductive elements.


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


FIG. 1 is a schematic illustration of a cardiac rhythm management (CRM) system including a defibrillation lead and a pulse generator according to one embodiment.



FIG. 2 is a schematic illustration of the defibrillation lead illustrated in FIG. 1 according to one embodiment.



FIGS. 3-5 are schematic illustrations of shocking electrode and MRI filter arrangements for the defibrillation lead of FIG. 1 according to various embodiments.



FIG. 6 is a schematic illustration showing a technique for manufacturing a shocking electrode and MRI filter arrangement for the defibrillation lead of FIG. 1 according to various embodiments.





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


FIG. 1 is a schematic illustration of a cardiac rhythm management (CRM) system 100 providing therapy to a patient's heart 102, which includes a right ventricle 104, right atrium 106, left ventricle 108, and left atrium 110. The CRM system 100 includes a medical device lead 112 such as a defibrillation lead and a pulse generator 114 coupled to a proximal end 116 of the lead 112 to perform desired set of operations. The pulse generator 114 generates signals for delivering treatment to the heart 102 with pacing and/or defibrillation capabilities. In various embodiments, the pulse generator 114 is an implantable cardioverter-defibrillator (ICD). In some embodiments, the CRM system 100 may include multiple leads for delivering therapy.


In some embodiments, the lead 112 includes a lead body 117, a shocking electrode 118, a pacing/sensing electrode 120, and one or more conductors (not shown in FIG. 1). The shocking electrode 118 is disposed proximate a distal end 122 of the lead 112 and is coupled to at least one conductor and is configured to deliver shock to the patient's heart 102 in scenarios when an anomaly, such as an arrhythmia, is sensed or detected. The electrode 120 is disposed at the distal end 122 of the lead 112 and is also connected to at least one conductor that enables the electrode 120 to sense and pace the patient's heart 102. The conductor enables the electrode 120 to sense and pace by conducting electrical signals generated by the heart 102 to the pulse generator 114 and the electrical pulses generated by the pulse generator 114 for pacing to the heart 102.


In the illustrated embodiment, the lead 112 is deployed in the right ventricle 104. However, in other embodiments, the lead 112 can be implanted in the right atrium 106 or both the right atrium 106 and the right ventricle 104, or a left chamber of the heart 102. In various embodiments, two or more leads 112 may be deployed within the heart 102 at different target regions.


The pulse generator 114 generally includes a power source and electronic circuitry configured to process and generate electrical signals. The power source includes a battery that provides power to the CRM system 100 to perform its operations. The electronic circuitry may include components for memory, processing, or the like. In some embodiments, the pulse generator 114 is implanted by forming a subcutaneous pocket in the pectoral girdle of the patient. Optionally, the pulse generator 114 can also be implanted in the thoracic cavity, abdominal region, neck region, or the like.


The following embodiments are primarily described in context of the CRM system 100. However, the skilled artisan will readily understand that the embodiments may also be used in conjunction with other implantable medical devices such as, but not limited to, deep brain stimulators, spinal cord stimulators, or the like.



FIG. 2 is a schematic illustration of the lead 112 illustrated in FIG. 1, according to one embodiment. The lead 112 includes the lead body 117, an electrical conductor 126, a low voltage conductor 128, a tubular conductive element 130, a layer of insulative material 132, and a tip electrode 134. In some embodiments, the tubular conductive element 130 is disposed over the lead body 117 that encompasses the electrical conductor 126 and the low voltage conductor 128 as shown in Section A-A of FIG. 2.


More particularly, the lead body 117 includes an insulative tubular member 136 having a proximal end (not shown in FIG. 2), a distal end 138, one or more conductor lumens (shown in Section A-A) extending either partially or entirely between the proximal end and the distal end 138 of the tubular member 136. In the illustrated embodiment, the tubular member 136 defines a first conductor lumen 140 that has a profile slightly smaller than that of a second conductor lumen 142.


The first conductor lumen 140 is configured to receive the electrical conductor 126. In some embodiments, the electrical conductor 126 can be a high voltage cable or wire extending from the proximal end of the tubular member 136 towards the distal end 138. The electrical conductor 126 is configured to carry high voltage electrical signals from the pulse generator 114 to deliver shock to the heart 102 (see FIG. 1). To deliver shocks, the electrical conductor 126 is electrically coupled to the tubular conductive element 130 at a connection location 144.


In some embodiments, the tubular conductive element 130 is a tube like structure including a proximal segment 146, an intermediate segment 148, and a distal segment 150. In various embodiments, the proximal segment 146 and the intermediate segment 148 are operable to filter electromagnetic energy from an external source such as an MRI. The distal segment 150 is operable as a shocking electrode configured to deliver shock to the heart 102. The layer of insulative material 132 is disposed over the proximal segment 146 and the intermediate segment 148 such that these segments will not be able to deliver energy to surrounding tissue.


In various embodiments, the lead 112 may include two or more tubular conductive elements 130 disposed along its length, a distal tubular conductive element, and a proximal tubular conductive element. In an example, the distally located tubular conductive element is positioned within the right ventricle 104 and the proximally located tubular conductive element is positioned within the right atrium 106 or superior vena cava. The two tubular conductive elements may be independently activated based on the requirement of therapy.


The second conductor lumen 142 is configured to receive a conductor such as a low voltage conductor 128. In some embodiments, the low voltage conductor 128 extends to the tip electrode 134 at the distal end 138 of the insulative tubular member 136 of the lead body 117. In one embodiment, the low voltage conductor 128 can be in the form of a single- or multi-filar coil conductor. In various embodiments, the low voltage conductor 128 can be a non-coiled conductor (e.g., a multi-strand cable, or the like). The low voltage conductor 128 is configured to convey electrical signals from the heart 102, such as electrical activity of the heart 102, to the pulse generator 114 to detect abnormal rhythms. The low voltage conductor 128 may also transmit pacing signals from the pulse generator 114 to the heart 102. In various embodiments, the low voltage conductor 128 can be configured as a relatively high inductance coil to inhibit induced currents in the conductor. In some embodiments, the low voltage conductor 128 may define a lumen configured to receive a stylet or guide wire (not shown) for implanting the lead 112 within the patient's body.


The tip electrode 134 connected to the distal end of the low voltage conductor 128 is in contact with the tissue, such as heart tissue, for sensing electrical signals produced by the heart 102 and/or pacing the heart 102 by transmitting the pulses generated by the pulse generator 114. In some embodiments, the tip electrode 134 can be engaged with the tissue by active fixation such as a helix screw that can be inserted into the tissue by rotation of the helix screw. To accomplish rotation of the helix screw, the tip electrode 134 is mechanically coupled to the low voltage conductor 128, which in turn is mechanically coupled to a rotatable element (e.g., a terminal pin) at the proximal end of the lead. In such scenarios, the tip electrode 134 conducts as well as secures, the lead 112 to the cardiac tissue. In other embodiments, the tip electrode 134 can be passively engaged with the tissue just by contacting the tissue, such as a ring electrode, a ball shape electrode, or the like.


In some embodiments, the layer of insulative material 132 and the insulative tubular member 136 can be formed using a suitable electrically insulative biocompatible material such as, but not limited to, silicone, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyvinylchloride (PVC), polyether-ester, polyamide, polyetheretherketone (PEEK), or the like. In some embodiments, the tubular member 136 and the conductor lumens 140, 142 have a circular cross-section. However, other suitable cross-sectional shapes may also be contemplated, such as but not limited to, rectangular, square, triangular, oval, or the like.



FIG. 3 is a schematic illustration of a shocking electrode (such as shocking electrode 118 of FIG. 1) and MRI filter arrangement for the lead 112 of FIG. 1. The shocking electrode and MRI filter arrangement together forms a part of the tubular conductive element 130. As shown, the tubular conductive element 130 includes the proximal segment 146, the intermediate segment 148 extending distally from the proximal segment 146, and the distal segment 150 extending distally from the intermediate segment 148. The proximal, intermediate, and distal segments 146, 148, 150, respectively, each include patterns of kerfs formed radially through the wall defining the tubular conductive element 130. The kerfs are slots created by cutting (e.g., laser cutting) or otherwise removing (e.g., by etching) material of the tubular conductive material 130 in a predetermined pattern. In some embodiments, the proximal segment 146, and the intermediate segment 148 constitutes the MRI filter arrangement and the distal segment 150 is the shocking electrode.


The proximal segment 146 includes a proximal end 152, a distal end 154, and a coiled conductor extending between the proximal end 152 and the distal end 154.


Referring to FIGS. 2 and 3, in some embodiments, the proximal segment 146 is operable as a transmission line filter configured to shield the electrical conductor from RF energy produced during an MRI scan, so as to cancel the effect of MRI interference in the electrical conductor 126. The electrical conductor 126 is connected to the tubular conductive element 130 between the proximal segment 146 and the intermediate segment 148 at the connection location 144. As shown, the distal end 154 of the proximal segment 146 is coupled to the electrical conductor 126.


The intermediate segment 148 is operable as an in-line tuning filter used to tune or choke the RF signals induced due to RF pulsating magnetic field or the MRI environment. The intermediate segment 148 has an inductance that poses high impedance to certain frequencies without affecting the flow of electrical signals generated by the pulse generator (such as pulse generator 114). When an alternating current is induced in the lead 112 due to RF signals, a magnetic field is generated around the intermediate segment 148 and this field opposes any further current changes. This enables the intermediate segment 148 to attenuate the undesired current or voltage signals generated within the lead 112 or the electrical conductor 126 such that the signals generated are not transmitted to other parts of the lead 112, particularly the shocking electrode. In some embodiments, the proximal segment 146 and the intermediate segment 148 may be tuned to different MRI frequencies such as 64 MHz, 128 MHz or other frequencies involved during MRI procedure.


In some embodiments, the proximal segment 146 and the intermediate segment 148 are configured and arranged to have kerfs formed in a helical pattern around the circumference and length of the tubular conductive element 130, such that the remaining conductive material also extends in a helical configuration. In various embodiments, the pitch (i.e., the distance between adjacent turns of the helically-arranged kerfs) can be substantially uniform along the length of the proximal and/or intermediate segments 146, 148. Alternatively, one or both of the proximal and distal segments 146, 150 can be configured such that the pitch(es) of the kerfs varies along all or part of the length of the segment. The variable pitch may alter the electrical properties of the proximal segment 146 and/or the intermediate segment 148. In one embodiment, the proximal segment 146 and the intermediate segment 148 are configured so as to have smaller pitch near the connection location 144.


The distal segment 150 forms a distal portion of the tubular conductive element 130. The distal segment 150 is operable as the shocking electrode configured to deliver shock or high voltage pulses to the heart. In the illustrated embodiment, the distal segment 150 is designed to have kerfs extending partially along the circumference of the tubular conductive element 130. When the electrical signal is sent to the distal segment 150, the kerfs direct the current to take a non-linear path distributing energy over a larger surface area, and thereby minimizing heating of surrounding tissue.


In various embodiments, the tubular conductive element 130 can be formed using a suitable non-ferromagnetic conducting biocompatible material such as, but not limited to, Nitinol™, gold, silver, stainless steel, copper, platinum, or a combination of these materials.



FIG. 4 is a schematic illustration of a shocking electrode and MRI filter arrangement for a lead 212 similar to lead 112 of FIG. 1 manufactured from a single tube of conductive material. In the illustrated embodiment, a tubular conductive element 230 includes a proximal segment 246, an intermediate segment 248, and a distal segment 250 formed by forming kerfs through the wall of a unitary tube. The electrical conductor 226 is mechanically and electrically coupled to the tubular conductive element 230 at a connection location 244 between the proximal segment 246 and the intermediate segment 248.


In some embodiments, a connector 256 (as shown in the detail view of FIG. 4) is used to couple the electrical conductor 226 to the tubular conductive element 230. In the illustrated embodiments, the connector 256 includes a saddle-shaped portion 258 configured to receive a distal end of the electrical conductor 226. The electrical conductor 226 is placed within the saddle-shaped portion 258 of the connector 256 and coupled to the connector 256. For fixation, techniques such as welding, soldering, heat bonding, crimping, or the like may be used. In some embodiments, the connector 256 includes a flap configured to tightly secure the electrical conductor 226 with the connector 256. Upon fixation, the connector 256, along with the electrical conductor 226, is disposed within the tubular conductive element 230. Then, the connector 256 is coupled to the tubular conductive element 230 by a suitable technique such as, but not limited to, welding, soldering, or the like. In some embodiments, the connector 256 is a metallic ring that electrically couples the electrical conductor 226 to the tubular conductive element 230.


Additionally, as shown, the proximal segment 246 and the intermediate segment 248 have variable pitches. In some embodiments, the pitches of the kerfs in the proximal segment 246 and the intermediate segment 248 decrease in a direction away from the connection location 244 where the electrical conductor 226 is coupled to the tubular conductive element 230 to reduce reflection at the connection location 244.



FIG. 5 is a schematic illustration of a shocking electrode and MRI filter arrangement for a lead 312, similar to the lead 112 of FIG. 1, manufactured from two tubes of conductive material. The shocking electrode and the MRI filter arrangement can be configured substantially similar to the shocking electrode and MRI filter arrangement of FIG. 4 except as described below. In the illustrated embodiment, the tubular conductive element 330 is formed by joining a first tube 360 and a second tube 362 at a weld joint. The first tube 360 includes a proximal segment 346 and the second tube 362 includes an intermediate segment 348 and a distal segment 350. A connector 356 having a saddle-shaped portion 358, similar to the connector 256 of FIG. 4, is coupled to an electrical conductor 326 and the second tube 362. Then, the first tube 360 is slid over the electrical conductor 326 and coupled to the second tube 362 forming the tubular conductive element 330. Coupling of the first tube 360 to the second tube 362 can be achieved by any suitable technique known in the art. Exemplary techniques include welding, soldering, heat bonding, or the like.



FIG. 6 is a schematic illustration showing a technique for manufacturing a shocking electrode and MRI filter arrangement for the lead of FIG. 1 according to various embodiments. In the illustrated embodiment, the shocking electrode and the MRI filter arrangement can be from a single tube of conductive material. The tubular conductive element 430 is mounted on a fixture 464. The fixture 464 is configured to hold and rotate the tubular conductive element 430 in a predefined manner. The fixture 464 may engage with a distal and/or a proximal end of the tubular conductive element 464.


Further, a laser 466 is deployed at a position over the tubular conductive element 430 mounted on the fixture 464. The laser 466 is configured to generate a high intensity light beam 468 and move axially in a transverse plane for cutting one or more kerfs 470 radially through the tubular conductive element 430. The laser 466 emits a high intensity beam of light that is made to fall on the tubular conductive element 430. The energy of the light beam 468 is transferred to the tubular conductive element 430, thereby melting and/or vaporizing the material of the tubular conductive element 430 and forming the kerfs 470. In some embodiments, the motion of the laser 466 can be controlled by an automated system causes the laser 466 output to follow a predetermined pattern.


In various embodiments, a CO2 laser is used to form the kerfs 470. Other suitable examples of the laser 466 that can be used to from the kerfs 470 include, but are not limited to, Nd-YAG laser, YAG laser, or the like. Alternatively, in some embodiments, plasma techniques may be employed to form kerfs 470 through the tubular conductive element 430.


In the various embodiments, the kerfs 470 can be formed so as to affect the electrical properties of the tubular conductive element 430. In some embodiments, a first pattern (not shown) of the kerfs 470 is cut along a first length of the tubular conductive material 430 and a second pattern of the kerfs 470 is cut along a second length of the tubular conductive element 430. The first pattern of the kerfs 470 includes a helical path formed along the first length, including the proximal segment and the intermediate segment. Further, in the illustrated embodiment, the second pattern of the kerfs 470 can include a helical pattern or a non-helical pattern along the second length. As shown, the non-helical pattern includes cuts or slots formed that extend partially along the circumference of the tubular conductive element 430.


In other embodiments, the kerfs 470 include a first pattern, a second pattern, and a third pattern of kerfs defined along different portions of the tubular conductive element 430. The first pattern defines a proximal segment (similar to proximal segment 146), a second pattern defines an intermediate segment (similar to intermediate segment 148), and a third pattern defines a distal segment (similar to distal segment 150) of the tubular conductive element 430. In a preferred embodiment, the first and the second patterns are helical patterns having a variable pitch. The variable pitch decreases with distance from the other of the first and second patterns. The third pattern is a non-helical pattern such that the proximal and intermediate segments have electrical impedances higher than the electrical impedance of the distal segment.


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
  • 1. A medical device lead comprising: an insulating tubular member having a proximal end, a distal end, and a lumen extending therebetween;an electrical conductor extending within the lumen from the proximal end toward the distal end; anda tubular conductive element disposed over the insulating tubular member and between the proximal end and the distal end, wherein the tubular conductive element is electrically coupled to the electrical conductor and has one or more kerfs formed in it to affect an electrical property of the tubular conductive element, wherein the one or more kerfs include kerfs formed in a helical pattern such that electrical current passing through the tubular conductive element travels along a helical path and the kerfs formed in the helical pattern have a variable pitch.
  • 2. The medical device lead of claim 1, wherein the tubular conductive element is configured to provide a shocking electrode.
  • 3. The medical device lead of claim 1, wherein the tubular conductive element includes a first segment and a second segment extending distally from the first segment, wherein the one or more kerfs are formed in each of the first segment and the second segment to affect electrical properties of the first segment and the second segment, wherein the first segment has a higher electrical impedance than the second segment.
  • 4. The medical device lead of claim 3, comprising a layer of insulative material disposed over the first segment.
  • 5. The medical device lead of claim 3, wherein the first segment is configured to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy.
  • 6. The medical device lead of claim 3, wherein the second segment is configured to provide a shocking electrode.
  • 7. A medical device lead comprising: an insulating tubular member having a proximal end, a distal end, and a lumen extending therebetween;an electrical conductor extending within the lumen from the proximal end toward the distal end; anda tubular conductive element disposed over the insulating tubular member and between the proximal end and the distal end, wherein the tubular conductive element is electrically coupled to the electrical conductor and has a first segment with first kerfs formed in it and a second segment extending distally from the first segment and with second kerfs formed in it, wherein the first kerfs are different than the second kerfs, and wherein the first kerfs and the second kerfs are configured to provide a higher electrical impedance in the first segment as compared to the second segment.
  • 8. The medical device lead of claim 7, wherein the first kerfs are formed in a helical pattern such that electrical current passing through the first segment travels along a helical path.
  • 9. The medical device lead of claim 7, wherein the second kerfs include a series of kerfs each extending partially circumferentially about the tubular conductive element and distributed along the length of the second segment, wherein each of the second kerfs is circumferentially offset from adjacent second kerfs so as to cause electrical current to assume a non-linear flow path through the second segment.
  • 10. The medical device lead of claim 7, comprising a layer of insulative material disposed over the first segment of the tubular conductive element and the first segment is configured to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy.
  • 11. The medical device lead of claim 7, wherein an outer surface of the second segment is uninsulated and the second segment is configured to provide a shocking electrode.
  • 12. An electrode component for an implantable medical device lead, the electrode component comprising: a tubular conductive element including a first segment, a second segment extending distally from the first segment, and a third segment extending distally from the second segment, wherein one or more kerfs are formed in each of the first segment, the second segment, and the third segment such that the first segment and the second segment have a higher electrical impedance than the third segment.
  • 13. The electrode component of claim 12, comprising a layer of insulative material disposed over the first segment and the second segment, wherein the first segment and the second segment are configured to inhibit induced currents in the tubular conductive element in the presence of an external source of electromagnetic energy.
  • 14. The electrode component of claim 12, wherein an outer surface of the third segment is uninsulated and the third segment is configured to provide a shocking electrode.
  • 15. The electrode component of claim 12, wherein the first segment, the second segment, and the third segment are formed from a single tube of conductive material.
  • 16. The electrode component of claim 12, wherein one or more of the first segment, the second segment, and the third segment are formed from separate tubes of conductive material.
CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No. 14/631,010, filed Feb. 25, 2015, now U.S. Pat. No. 9,504,821, which claims priority to Provisional Application No. 61/945,081, filed Feb. 26, 2014, all of which are herein incorporated by reference in their entirety.

US Referenced Citations (390)
Number Name Date Kind
3614692 Rozelle et al. Oct 1971 A
4131759 Felkel Dec 1978 A
4135518 Dutcher Jan 1979 A
4146036 Dutcher et al. Mar 1979 A
4209019 Dutcher et al. Jun 1980 A
4253462 Dutcher et al. Mar 1981 A
4350169 Dutcher et al. Sep 1982 A
4381013 Dutcher Apr 1983 A
4404125 Abolins et al. Sep 1983 A
4437474 Peers-Trevarton Mar 1984 A
4484586 McMickle et al. Nov 1984 A
4493329 Crawford et al. Jan 1985 A
4574800 Peers-Trevarton Mar 1986 A
4643202 Roche Feb 1987 A
4643203 Labbe Feb 1987 A
4649938 McArthur Mar 1987 A
4869970 Gulla et al. Sep 1989 A
5002067 Berthelsen et al. Mar 1991 A
5003975 Hafelfinger et al. Apr 1991 A
5020545 Soukup Jun 1991 A
5056516 Spehr Oct 1991 A
5074313 Dahl et al. Dec 1991 A
5144960 Mehra et al. Sep 1992 A
5201865 Kuehn Apr 1993 A
5217010 Tsitlik et al. Jun 1993 A
5222506 Patrick et al. Jun 1993 A
5231996 Bardy et al. Aug 1993 A
5241957 Camps et al. Sep 1993 A
5243911 Dow et al. Sep 1993 A
5246014 Williams et al. Sep 1993 A
5259395 Li Nov 1993 A
5300108 Rebell et al. Apr 1994 A
5324322 Grill, Jr. et al. Jun 1994 A
5330522 Kreyenhagen Jul 1994 A
5354327 Smits Oct 1994 A
5370666 Lindberg et al. Dec 1994 A
5378234 Hammerslag et al. Jan 1995 A
5387199 Siman et al. Feb 1995 A
5417208 Winkler May 1995 A
5425755 Doan Jun 1995 A
5456707 Giele Oct 1995 A
5476485 Weinberg et al. Dec 1995 A
5483022 Mar Jan 1996 A
5522872 Hoff Jun 1996 A
5522875 Gates et al. Jun 1996 A
5534018 Wahlstrand et al. Jul 1996 A
5542173 Mar et al. Aug 1996 A
5542174 Chiu Aug 1996 A
5545205 Schulte et al. Aug 1996 A
5549646 Katz et al. Aug 1996 A
5554139 Okajima Sep 1996 A
5574249 Lindsay Nov 1996 A
5584873 Shoberg et al. Dec 1996 A
5599576 Opolski Feb 1997 A
5609622 Soukup et al. Mar 1997 A
5618208 Crouse et al. Apr 1997 A
5649974 Nelson et al. Jul 1997 A
5658709 Layman et al. Aug 1997 A
5676694 Boser et al. Oct 1997 A
5693523 Watanabe et al. Dec 1997 A
5727552 Ryan Mar 1998 A
5727553 Saad Mar 1998 A
5728149 Laske et al. Mar 1998 A
5755742 Schuelke et al. May 1998 A
5760341 Laske et al. Jun 1998 A
5766227 Nappholz et al. Jun 1998 A
5800496 Swoyer et al. Sep 1998 A
5810887 Accorti, Jr. et al. Sep 1998 A
5817136 Nappholz et al. Oct 1998 A
5824026 Diaz Oct 1998 A
5833715 Vachon et al. Nov 1998 A
5849031 Martinez et al. Dec 1998 A
5891114 Chien et al. Apr 1999 A
5891179 Er et al. Apr 1999 A
5935159 Cross, Jr. et al. Aug 1999 A
5957966 Schroeppel et al. Sep 1999 A
5957970 Shoberg et al. Sep 1999 A
5968087 Hess et al. Oct 1999 A
6016447 Juran et al. Jan 2000 A
6057031 Breme et al. May 2000 A
6078840 Stokes Jun 2000 A
6083216 Fischer, Sr. Jul 2000 A
6101417 Vogel et al. Aug 2000 A
6106522 Fleischman et al. Aug 2000 A
6141593 Patag Oct 2000 A
6143013 Samson et al. Nov 2000 A
6178355 Williams et al. Jan 2001 B1
6192280 Sommer et al. Feb 2001 B1
6208881 Champeau Mar 2001 B1
6249708 Nelson et al. Jun 2001 B1
6256541 Heil et al. Jul 2001 B1
6259954 Conger et al. Jul 2001 B1
6289250 Tsuboi et al. Sep 2001 B1
6295476 Schaenzer Sep 2001 B1
6304784 Allee et al. Oct 2001 B1
6317633 Jorgenson et al. Nov 2001 B1
6356790 Maguire Mar 2002 B1
6360129 Ley et al. Mar 2002 B1
6400992 Borgersen et al. Jun 2002 B1
6428537 Swanson et al. Aug 2002 B1
6434430 Borgersen et al. Aug 2002 B2
6456888 Skinner et al. Sep 2002 B1
6493591 Stokes Dec 2002 B1
6501991 Honeck et al. Dec 2002 B1
6501994 Janke et al. Dec 2002 B1
6510345 Van Bentem Jan 2003 B1
6516230 Williams et al. Feb 2003 B2
6526321 Spehr Feb 2003 B1
6564107 Bodner et al. May 2003 B1
6671554 Gibson et al. Dec 2003 B2
6701191 Schell Mar 2004 B2
6721600 Jorgenson et al. Apr 2004 B2
6721604 Robinson et al. Apr 2004 B1
6813251 Garney et al. Nov 2004 B1
6813521 Bischoff et al. Nov 2004 B2
6850803 Jimenez et al. Feb 2005 B1
6854994 Stein et al. Feb 2005 B2
6866044 Bardy et al. Mar 2005 B2
6906256 Wang Jun 2005 B1
6909256 Itabashi Jun 2005 B2
6920361 Williams Jul 2005 B2
6925334 Salys Aug 2005 B1
6944489 Zeijlemaker et al. Sep 2005 B2
6949929 Gray et al. Sep 2005 B2
6978185 Osypka Dec 2005 B2
6985755 Cadieux et al. Jan 2006 B2
6985775 Rinke et al. Jan 2006 B2
6993373 Vrijheid et al. Jan 2006 B2
6999818 Stevenson et al. Feb 2006 B2
6999821 Jenney et al. Feb 2006 B2
7013180 Dublin et al. Mar 2006 B2
7013182 Krishnan Mar 2006 B1
7047075 Stubbs May 2006 B2
7047083 Gunderson et al. May 2006 B2
7050855 Zeijlemaker et al. May 2006 B2
7113827 Silvestri et al. Sep 2006 B2
7123013 Gray Oct 2006 B2
7127294 Wang et al. Oct 2006 B1
7135978 Gisselberg et al. Nov 2006 B2
7138582 Lessar et al. Nov 2006 B2
7158837 Osypka et al. Jan 2007 B2
7174219 Wahlstrand et al. Feb 2007 B2
7174220 Chitre et al. Feb 2007 B1
7205768 Schulz et al. Apr 2007 B2
7239916 Thompson et al. Jul 2007 B2
7242987 Holleman et al. Jul 2007 B2
7257449 Bodner Aug 2007 B2
7289851 Gunderson et al. Oct 2007 B2
7363090 Halperin et al. Apr 2008 B2
7369898 Kroll et al. May 2008 B1
7378931 Odahara et al. May 2008 B2
7388378 Gray et al. Jun 2008 B2
7389148 Morgan Jun 2008 B1
7453344 Maeda et al. Nov 2008 B2
7535363 Gisselberg et al. May 2009 B2
7571010 Zarembo et al. Aug 2009 B2
7584005 Jain Sep 2009 B1
7610101 Wedan et al. Oct 2009 B2
7630761 Salo et al. Dec 2009 B2
7689291 Polkinghorne et al. Mar 2010 B2
7765005 Stevenson Jul 2010 B2
7853332 Olsen et al. Dec 2010 B2
7877150 Hoegh et al. Jan 2011 B2
7912552 Przybyszewski Mar 2011 B2
7917213 Bulkes et al. Mar 2011 B2
7933662 Marshall et al. Apr 2011 B2
7953499 Knapp et al. May 2011 B2
7986999 Wedan et al. Jul 2011 B2
7991484 Sengupta et al. Aug 2011 B1
8000801 Stevenson et al. Aug 2011 B2
8027736 Wahlstrand et al. Sep 2011 B2
8032230 Cox et al. Oct 2011 B1
8046084 Bodner Oct 2011 B2
8099177 Dahlberg Jan 2012 B2
8103360 Foster Jan 2012 B2
8108054 Helland Jan 2012 B2
8145324 Stevenson et al. Mar 2012 B1
8170688 Wedan et al. May 2012 B2
8200342 Stevenson et al. Jun 2012 B2
8214055 Erickson Jul 2012 B2
8244346 Foster et al. Aug 2012 B2
8255055 Ameri Aug 2012 B2
8306630 Stubbs et al. Nov 2012 B2
8315715 Erickson Nov 2012 B2
8332050 Perrey et al. Dec 2012 B2
8335572 Ameri Dec 2012 B2
8369964 Ameri Feb 2013 B2
8391994 Foster et al. Mar 2013 B2
8401671 Wedan et al. Mar 2013 B2
8406895 Erbstoeszer et al. Mar 2013 B2
8543209 Tyers et al. Sep 2013 B2
8543218 Erickson Sep 2013 B2
8666508 Foster et al. Mar 2014 B2
8666512 Walker et al. Mar 2014 B2
8670828 Hall et al. Mar 2014 B2
8670840 Wedan et al. Mar 2014 B2
8676344 Desai et al. Mar 2014 B2
8676351 Foster et al. Mar 2014 B2
8682451 Wengreen et al. Mar 2014 B2
8688236 Foster Apr 2014 B2
8731685 Ameri May 2014 B2
8744600 Perrey et al. Jun 2014 B2
8798767 Foster et al. Aug 2014 B2
8825179 Walker et al. Sep 2014 B2
8825181 Foster et al. Sep 2014 B2
8954168 Foster Feb 2015 B2
8983623 Foster et al. Mar 2015 B2
9050457 Foster et al. Jun 2015 B2
9199077 Foster et al. Dec 2015 B2
9203648 Shraim et al. Dec 2015 B2
9254380 Ameri et al. Feb 2016 B2
9504822 Foster Nov 2016 B2
20020065544 Smits May 2002 A1
20020072769 Silvian et al. Jun 2002 A1
20020111664 Bartig et al. Aug 2002 A1
20020128689 Connelly et al. Sep 2002 A1
20020144720 Zahorik et al. Oct 2002 A1
20030028231 Partridge et al. Feb 2003 A1
20030050680 Gibson et al. Mar 2003 A1
20030063946 Williams et al. Apr 2003 A1
20030083723 Wilkinson et al. May 2003 A1
20030083726 Zeijlemaker et al. May 2003 A1
20030092303 Osypka May 2003 A1
20030093136 Osypka et al. May 2003 A1
20030093138 Osypka et al. May 2003 A1
20030139794 Jenney et al. Jul 2003 A1
20030140931 Zeijlemaker et al. Jul 2003 A1
20030144705 Funke Jul 2003 A1
20030144716 Reinke et al. Jul 2003 A1
20030144718 Zeijlemaker Jul 2003 A1
20030144719 Zeijlemaker Jul 2003 A1
20030144720 Villaseca et al. Jul 2003 A1
20030144721 Villaseca et al. Jul 2003 A1
20030204217 Greatbatch Oct 2003 A1
20040014355 Osypka et al. Jan 2004 A1
20040064161 Gunderson et al. Apr 2004 A1
20040064173 Hine et al. Apr 2004 A1
20040064174 Belden Apr 2004 A1
20040088033 Smits et al. May 2004 A1
20040097965 Gardeski et al. May 2004 A1
20040122490 Reinke et al. Jun 2004 A1
20040153049 Hewitt et al. Aug 2004 A1
20040162600 Williams Aug 2004 A1
20040167442 Shireman et al. Aug 2004 A1
20040172117 Hill et al. Sep 2004 A1
20040193140 Griffin et al. Sep 2004 A1
20040243210 Morgan et al. Dec 2004 A1
20040267107 Lessar et al. Dec 2004 A1
20050030322 Gardos Feb 2005 A1
20050070972 Wahlstrand et al. Mar 2005 A1
20050090886 MacDonald et al. Apr 2005 A1
20050113873 Weiner et al. May 2005 A1
20050113876 Weiner et al. May 2005 A1
20050136385 Mann et al. Jun 2005 A1
20050149169 Wang et al. Jul 2005 A1
20050177135 Hildebrand et al. Aug 2005 A1
20050182471 Wang Aug 2005 A1
20050197677 Stevenson Sep 2005 A1
20050222642 Przybyszewski et al. Oct 2005 A1
20050222656 Wahlstrand et al. Oct 2005 A1
20050222657 Wahlstrand et al. Oct 2005 A1
20050222658 Hoegh et al. Oct 2005 A1
20050222659 Olsen et al. Oct 2005 A1
20050227398 Anderson et al. Oct 2005 A1
20050246007 Sommer et al. Nov 2005 A1
20050267556 Shuros et al. Dec 2005 A1
20050272280 Osypka Dec 2005 A1
20050283167 Gray Dec 2005 A1
20060009819 Przybyszewski Jan 2006 A1
20060030774 Gray et al. Feb 2006 A1
20060037461 Yasumura Feb 2006 A1
20060041293 Mehdizadeh et al. Feb 2006 A1
20060041294 Gray Feb 2006 A1
20060041296 Bauer et al. Feb 2006 A1
20060089691 Kaplan et al. Apr 2006 A1
20060089695 Bolea et al. Apr 2006 A1
20060089696 Olsen et al. Apr 2006 A1
20060093685 Mower et al. May 2006 A1
20060105066 Teague et al. May 2006 A1
20060106442 Richardson et al. May 2006 A1
20060118758 Wang et al. Jun 2006 A1
20060129043 Ben-Jacob et al. Jun 2006 A1
20060167536 Nygren et al. Jul 2006 A1
20060200218 Wahlstrand Sep 2006 A1
20060229693 Bauer et al. Oct 2006 A1
20060247747 Olsen et al. Nov 2006 A1
20060247748 Wahlstrand et al. Nov 2006 A1
20060252314 Atalar et al. Nov 2006 A1
20060253180 Zarembo et al. Nov 2006 A1
20060271138 MacDonald Nov 2006 A1
20060293737 Krishnan Dec 2006 A1
20070010702 Wang et al. Jan 2007 A1
20070027532 Wang et al. Feb 2007 A1
20070055317 Stahmann et al. Mar 2007 A1
20070106332 Denker et al. May 2007 A1
20070112398 Stevenson et al. May 2007 A1
20070156205 Larson et al. Jul 2007 A1
20070179577 Marshall et al. Aug 2007 A1
20070179582 Marshall et al. Aug 2007 A1
20070191914 Stessman Aug 2007 A1
20070208383 Williams Sep 2007 A1
20070255317 Fanton et al. Nov 2007 A1
20070255378 Polkinghorne et al. Nov 2007 A1
20080009905 Zeijlemaker Jan 2008 A1
20080033497 Bulkes et al. Feb 2008 A1
20080039709 Karmarkar Feb 2008 A1
20080049376 Stevenson et al. Feb 2008 A1
20080051854 Bulkes et al. Feb 2008 A1
20080057784 Zarembo et al. Mar 2008 A1
20080058902 Gray et al. Mar 2008 A1
20080119917 Geistert May 2008 A1
20080125754 Beer et al. May 2008 A1
20080129435 Gray Jun 2008 A1
20080132985 Wedan et al. Jun 2008 A1
20080132986 Gray et al. Jun 2008 A1
20080140152 Imran et al. Jun 2008 A1
20080154348 Atalar et al. Jun 2008 A1
20080208290 Phillips et al. Aug 2008 A1
20080243218 Bottomley et al. Oct 2008 A1
20080262584 Bottomley et al. Oct 2008 A1
20080269831 Erickson Oct 2008 A1
20090005825 MacDonald Jan 2009 A1
20090024180 Kisker et al. Jan 2009 A1
20090024197 Jensen Jan 2009 A1
20090099440 Viohl Apr 2009 A1
20090099555 Viohl et al. Apr 2009 A1
20090118610 Karmarkar et al. May 2009 A1
20090149920 Li et al. Jun 2009 A1
20090149933 Ameri Jun 2009 A1
20090149934 Ameri et al. Jun 2009 A1
20090198314 Foster et al. Aug 2009 A1
20090204171 Ameri Aug 2009 A1
20090210022 Powers Aug 2009 A1
20090270948 Nghiem et al. Oct 2009 A1
20090270956 Vase et al. Oct 2009 A1
20090281608 Foster Nov 2009 A1
20100010602 Wedan et al. Jan 2010 A1
20100016935 Strandberg et al. Jan 2010 A1
20100049290 Min et al. Feb 2010 A1
20100103215 Iriguchi Apr 2010 A1
20100106215 Stubbs et al. Apr 2010 A1
20100114277 Zhao et al. May 2010 A1
20100125320 Polkinghorne et al. May 2010 A1
20100137928 Duncan et al. Jun 2010 A1
20100174348 Bulkes et al. Jul 2010 A1
20100174349 Stevenson et al. Jul 2010 A1
20100234929 Scheuermann Sep 2010 A1
20100249892 Bulkes et al. Sep 2010 A1
20100292744 Hill et al. Nov 2010 A1
20100331936 Perrey et al. Dec 2010 A1
20110060394 Poore Mar 2011 A1
20110079423 Zhao et al. Apr 2011 A1
20110087299 Ameri Apr 2011 A1
20110087302 Ameri Apr 2011 A1
20110093054 Ameri Apr 2011 A1
20110160805 Erbstoeszer et al. Jun 2011 A1
20110160816 Stubbs et al. Jun 2011 A1
20110160817 Foster et al. Jun 2011 A1
20110160818 Struve Jun 2011 A1
20110160828 Foster et al. Jun 2011 A1
20110160829 Foster et al. Jun 2011 A1
20110208280 Li et al. Aug 2011 A1
20110218422 Atalar et al. Sep 2011 A1
20110238146 Wedan et al. Sep 2011 A1
20110288403 Kondabatni et al. Nov 2011 A1
20120016451 Struve et al. Jan 2012 A1
20120022356 Olsen et al. Jan 2012 A1
20120035698 Johnson et al. Feb 2012 A1
20120053662 Foster et al. Mar 2012 A1
20120101558 Kampa et al. Apr 2012 A1
20120109270 Foster May 2012 A1
20120143273 Stubbs et al. Jun 2012 A1
20120161901 Stevenson et al. Jun 2012 A1
20120179233 Wedan et al. Jul 2012 A1
20120232609 Tyers et al. Sep 2012 A1
20120253340 Stevenson et al. Oct 2012 A1
20120271394 Foster et al. Oct 2012 A1
20130116764 Walker et al. May 2013 A1
20130123884 Ameri May 2013 A1
20130158641 Foster et al. Jun 2013 A1
20130190849 Perrey et al. Jul 2013 A1
20130190850 Wedan et al. Jul 2013 A1
20130282093 Walker et al. Oct 2013 A1
20130325093 Foster Dec 2013 A1
20140067030 Walker et al. Mar 2014 A1
20140114383 Foster et al. Apr 2014 A1
20140155972 Foster et al. Jun 2014 A1
20140324139 Foster et al. Oct 2014 A1
20150105846 Foster Apr 2015 A1
20150182744 Foster et al. Jul 2015 A1
Foreign Referenced Citations (47)
Number Date Country
1154833 Oct 1983 CA
1762510 Apr 2006 CN
1905789 Jan 2007 CN
101039619 Sep 2007 CN
101553165 Oct 2009 CN
102186534 Sep 2011 CN
102209575 Oct 2011 CN
104736196 Jun 2015 CN
0897997 Feb 2003 EP
1594564 Nov 2005 EP
1852810 Nov 2007 EP
2445577 May 2012 EP
2227289 Jul 2015 EP
2890446 Jul 2015 EP
2908903 Aug 2015 EP
H0747139 Feb 1995 JP
2001522631 Nov 2001 JP
2004511293 Apr 2004 JP
2004141679 May 2004 JP
2005501673 Jan 2005 JP
2005515852 Jun 2005 JP
2005515854 Jun 2005 JP
2005522301 Jul 2005 JP
2007520254 Jul 2007 JP
2011504405 Feb 2011 JP
2011509813 Mar 2011 JP
2015520007 Jul 2015 JP
WO9606655 Mar 1996 WO
WO9923958 May 1999 WO
WO0232325 Apr 2002 WO
WO03063946 Aug 2003 WO
WO03063953 Aug 2003 WO
WO03089045 Oct 2003 WO
WO2004073791 Sep 2004 WO
WO2005030322 Apr 2005 WO
WO2006105066 Mar 2006 WO
WO2006093685 Sep 2006 WO
WO2007047966 Apr 2007 WO
WO2007089986 Aug 2007 WO
WO2007118194 Oct 2007 WO
WO2008051122 May 2008 WO
WO2009100003 Aug 2009 WO
WO20090137186 Nov 2009 WO
WO2010078552 Jul 2010 WO
2011081713 Jul 2011 WO
2012038378 Mar 2012 WO
2014066010 May 2014 WO
Non-Patent Literature Citations (32)
Entry
International Preliminary Report on Patentability issued in PCT/US2015/017473, mailed Sep. 9, 2016, 8 pages.
International Search Report and Written Opinion issued in PCT/US2013/065517, mailed Dec. 20, 2013, 11 pgs.
“High Voltage Engineering and Testing, 2nd Edition”, edited by Hugh M. Ryan, Institution of Engineering and Technology, 2001, 15 pages.
Avalanche Breakdown, Wikipedia Article, captured Apr. 6, 2010, [http://en.wikipedia.org/wiki/Avalanche—breakdown].
Basso, Christophe, “SPICE Model Simulates Spark-Gap Arrestor”, Electronics Design, Strategy, and News (EDN), Jul. 3, 1997, 4 pages.
Citel Inc., Data Sheet, BH Series 2 Electrode Miniature Gas Discharge Tube Surge Arrester—8mm, May 14, 2009, 2 pages.
File History for U.S. Appl. No. 11/015,807, filed Dec. 17, 2004 to Cooke, Daniel J. et al.
Gray, Robert W. et al., “Simple design changes to wires to substantially reduce MRI-induced heating at 1.5 T: implications for implanted leads”, Magnetic Resonance Imaging 23 (2005) 887-891.
Hayes, David L., Chapter 4, “Generator and Lead Selection” from book entitled “Cardiac Pacing and Defibrillation a Clinical Approach”, John Wiley & Sons, (c) 2000 Mayo Foundation, p. 129-157.
International Preliminary Examination Report issued in PCT/US2013/065517, completed Apr. 21, 2015, 8 pages.
International Search Report and Written Opinion issued in PCT/US2008/085518 on Oct. 29, 2009, 15 pages.
International Search Report and Written Opinion issued in PCT/US2009/032838, mailed May 4, 2009, 14 pages.
International Search Report and Written Opinion issued in PCT/US2009/038629, mailed Jun. 29, 2009, 11 pages.
International Search Report and Written Opinion issued in PCT/US2009/056843, mailed Dec. 29, 2009, 13 pages.
International Search Report and Written Opinion issued in PCT/US2010/024062, mailed Sep. 27, 2010.
International Search Report and Written Opinion issued in PCT/US2010/033686 on Aug. 10, 2010, 12 pages.
International Search Report and Written Opinion issued in PCT/US2010/048620, mailed Apr. 5, 2011, 10 pages.
International Search Report and Written Opinion issued in PCT/US2010/053223, mailed Dec. 27, 2010, 11 pages.
International Search Report and Written Opinion issued in PCT/US2010/055130, mailed Mar. 10, 2011, 11 pages.
International Search Report and Written Opinion issued in PCT/US2010/055653, mailed Feb. 1, 2011, 14 pages.
International Search Report and Written Opinion issued in PCT/US2011/052541, dated Mar. 9, 2012, 22 pages.
International Search Report and Written Opinion issued in PCT/US2012/055673, mailed Dec. 13, 2012, 10 pages.
International Search Report and Written Opinion issued in PCT/US2013/037432, mailed Nov. 19, 2013, 17 pages.
International Search Report and Written Opinion issued in PCT/US2013/057732, mailed Dec. 13, 2013, 11 pages.
International Search Report and Written Opinion issued in PCT/US2015/017473, mailed May 20, 2015, 10 pages.
Invitation to Pay Additional Fees and Partial Search Report, dated Aug. 17, 2009, issued in PCT/US2008/085533, 6 pages.
Invitation to Pay Additional Fees and Partial Search Report, issued in PCT/US2010/024062, mailed May 7, 2010.
Partial International Search Report issued in PCT/US2011/052541, mailed Dec. 6, 2011, 4 pages.
Partial International Search Report issued in PCT/US2013/013432, mailed Jul. 17, 2013, 6 pages.
Partial International Search Report issued in PCT/US2013/037432, mailed Jul. 17, 2013, 6 pages.
Static Spark Gap Analysis, captured Dec. 24, 2002, [http://www.richieburnett.co.uk/static.html].
Third Party Submission Under 37 CFR 1.290 filed in U.S. Appl. No. 14/056,746 on May 20, 2014, 13 pages.
Related Publications (1)
Number Date Country
20160361538 A1 Dec 2016 US
Provisional Applications (1)
Number Date Country
61945081 Feb 2014 US
Continuations (1)
Number Date Country
Parent 14631010 Feb 2015 US
Child 15245600 US