Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/056—Transvascular endocardial electrode systems
  • A61N1/057—Anchoring means; Means for fixing the head inside the heart

Definitions

• the present invention relates generally to surgical devices and methods for retaining medical devices within the body, and more specifically to a method and system for anchoring an intravascular implantable device within a vessel that is located superior to the heart.
• Implantable medical devices such as pacemakers, defibrillators, and implantable cardioverter defibrillators (“ICDs”) have been successfully implanted in patients for years for treatment of heart rhythm conditions.
• Pacemakers are implanted to detect periods of bradycardia and deliver low energy electrical stimuli to increase the heart rate.
• ICDs are implanted in patients to cardiovert or defibrillate the heart by delivering high energy electrical stimuli to slow or reset the heart rate in the event a ventricular tachycardia (VT) or ventricular fibrillation (VF) is detected.
• VT ventricular tachycardia
• VF ventricular fibrillation
• implantable device detects an atrial fibrillation (AF) episode and delivers electrical stimuli to the atria to restore electrical coordination between the upper and lower chambers of the heart.
• AF atrial fibrillation
• Still another type of implantable device stores and delivers drug ad/or gene therapies to treat a variety of conditions, including cardiac arrhythmias.
• the current generation for all of these implantable devices are typically can-shaped devices implanted under the skin that deliver therapy via leads that are implanted in the heart via the patient's vascular system.
• Next generation implantable medical devices may take the form of elongated intravascular devices that are implanted within the patient's vascular system, instead of under the skin. Examples of these intravascular implantable devices are described, for example, in U.S. Patent No. 7,082,336, U.S. Published Patent Application Nos. 2005/0043765A1 , 2005/0208471 Al and 2006/0217779A1. These devices contain electric circuitry and/or electronic components that are hermetically sealed to prevent damage to the electronic components and the release of contaminants into the bloodstream. Due to the length of these implantable devices, which in some cases can be approximately 10-60cm in length, the devices generally are designed to be flexible enough to move through the vasculature while being sufficiently rigid to protect the internal components.
• the anchoring system was arranged proximate the middle of the intravascular implantable device so as to be positioned in the vena cava within the thorax. This arrangement anchored the intravascular implantable device near the middle of the patient's torso at a location generally corresponding to the diaphragm.
• the anchoring system was integrated with the body of the intravascular implantable device.
• the anchoring system was a separate device, such as a stent, that was used to pin the body of the intravascular implantable device in position between the stent and the vessel wall.
• a lead extending from a distal end of the body of the intravascular device would also be anchored in the vasculature, such as in a subclavian vein.
• An alternative integrated anchoring system for an intravascular implantable device is described in some of the embodiments shown in U.S. Published Patent Application No. 2005/0208471 Al .
• This alternative integrated anchoring system utilized a radially expandable member positioned proximate the middle of the body of the device to secure the device.
• the radially expandable member centered the device within the diameter of the vessel.
• two or more radially expandable members were used to secure the middle of the body of the device within a vessel.
• intravascular implantable devices are intended to provide temporary or initial treatment for a condition, and the devices are not intended to remain implanted for the remainder of the patient's life. Therefore, it may become necessary to extract or explant the intravascular implantable device during the life of a patient.
• the device commonly becomes fused to the anchor and/or to the vasculature due to thrombus formation and/or endothelialization,
• intravascular implantable devices represent a significant improvement over conventional implantable devices that are implanted subcutaneously, there are opportunities to improve and refine the designs for such intravascular devices. Accordingly, it would be desirable to provide for an improved design of an anchoring arrangement for an intravascular implantable device.
• the present invention is directed to methods and systems for anchoring an intravascular implantable device within a vessel that is located superior to the heart, i.e. above the heart in a direction toward the head of a patient.
• the present invention utilizes only a single anchoring arrangement positioned proximate a distal portion of the intravascular implantable device.
• the present invention utilizes an anchoring arrangement that interacts with a distal portion of the intravascular implantable device that is generally smaller in cross-sectional area than a cross-sectional area of the body portion of the device.
• the present invention utilizes an anchoring arrangement that interacts with a distal portion of the intravascular device that is generally separable from the body portion of the device and contains no internal spaces for active components of the device.
• embodiments of the present invention anchor the body portion of the intravascular implantable device in a vein that is located superior to the heart and still generally within the torso, such as the right or left cephalic veins, the right or left innominate (brachiocephalic) veins or the right or left subclavian veins.
• the inventors of the present invention discovered that the previous anchoring arrangement generally moved in synchrony with respiration, rubbing the anchor and the intravascular implantable device against the vascular walls of the inferior vena cava and thereby causing unwanted irritation, thrombosis and/or fibrosis.
• Anchoring in the middle of the device also tended to constrain the movement of the device within the inferior vena cava and created more locations along the vessel for unwanted irritation, thrombosis and/or fibrosis.
• the intravascular implantable device is anchored superior to the heart, and in one embodiment is anchored in veins that are superior to the superior vena cava and still within the torso of the body, such as the cephalic vein, the innominate vein and the subclavian vein.
• the intravascular implantable device may be any one or a combination of defibrillator, cardioverter, pacemaker, monitor or drug/gene therapy delivery device and may be either a temporary or permanent device.
• the tether portion of the implantable device extends across the sub- clavicle crush zone and the anchor is located peripheral of the sub-clavicle crush zone.
• the distal portion of the body of the device is proximate, but generally does not extend into, the subclavian crush zone.
• the anchor is located superior to the heart and in a manner so as to minimize interference with the patient's muscular-skeletal anatomy.
• the present invention solves the problems of previously utilized anchor locations by providing a tether portion at a distal portion of the body of the implantable device.
• the tether portion is anchored into the vasculature superior to the heart with a conventional stent.
• the vascular anchor is preferably separate from the implantable device and captures a tether portion that extends from the implantable device between the anchor and the vasculature.
• the anchor may be incorporated as part of the implantable device.
• the vascular anchor and/or the tether portion of the implantable device include mechanisms to optimize interference between the anchor and the tether portion in a manner that does not induce a rupture of the vessel while providing for adequate clinical attachment of the implantable device within the patient.
• the anchoring of the present invention at the distal portion of the body of the intravascular implantable device permits the main body portion and proximal body portions of the device to more effectively float in the bloodstream, thereby reducing the risk of thrombosis for those portions, as well as reducing the risk of impact or trauma on the vessel walls. It is theorized that the reduction in the risk of thrombosis may be at least partly due to the more intermittent and random nature of the interaction of these portions of the body of the device with the vessel walls which reduces the indwelling time required for effective fibrosis of the device against the vessel wall, and also tends to reduce the size of any thrombosis formed on the device.
• the present invention takes advantage of the fact that stenosis of the cephalic vein, the innominate vein or the subclavian vein is less critical than stenosis of many other veins and that closure or loss of those veins is not life threatening.
• the anchoring of the intravascular implantable device superior to the heart in accordance with the present invention provides for easier bailout in the event of a problem with the device requiring explantation or in the event that the device is to be removed and replaced with, for example, a conventional can- based device.
• the present invention is directed to an intravascular implantable medical device that includes a detachable, severable, releasable, or otherwise removable tether arrangement.
• the detachable tether arrangement comprises a tip assembly that includes a break-away joint and a tether portion, and may also include a connector and an extension portion connected to an end of an elongated intravascular implantable medical device.
• the break-away joint is disposed between the extension portion and the tether portion.
• the break-away joint may comprise a snap-fit, threaded joint, or other similar configurations.
• the extension portion may comprise a housing or other arrangement that includes an antenna for transmitting and receiving data.
• the extension portion may also include a lead for defibrillation, pacing, and/or sensing cardiac electrical activity.
• the tether arrangement is designed to be secured within a patient's vasculature with a vascular anchor either in the form of a separate anchor, such as a conventional stent, or by various integrated retention arrangements.
• the vascular anchor is separate from the implantable device and captures a tether portion that extends from the implantable device between the anchor and the vasculature.
• the anchor may be incorporated as part of the implantable device.
• the vascular anchor and/or the implantable device include mechanisms to optimize interference between the anchor and the tether portion in a way that does not induce a rupture of the vessel while providing for adequate clinical attachment of the implantable device within the patient.
• embodiments of the present invention utilize a detachable tether arrangement positioned proximate and end of the elongated body portion of the intravascular implantable device which does not require that the anchoring arrangement be extracted in order to explant the body portion of the intravascular implantable device.
• the detachable tether arrangement is utilized in conjunction with a superior anchoring arrangement that enables primary explantation access via a femoral puncture to retrieve the intravascular implantable device by detaching the tether portion at the break-away joint.
• a secondary, fallback access that can occur by a subclavian vessel puncture in the event that the primary explantation access is unsuccessful in retrieving the intravascular implantable device.
• the secondary access affords a more direct access to the detach/release mechanisms of the tether arrangement and the anchor location, and also permits control of both ends of the intravascular implantable device during the explanation procedure.
• the intravascular implantable device may be extracted by disconnecting, detaching or otherwise releasing the break-away joint and removing the body portion of the intravascular implantable device.
• the tether portion and the anchor may remain secured within the vasculature and need not be explanted.
• the tip assembly includes a break-away joint non-releasably coupled to the tether portion, and adapted to be releasably coupled to an intravascular implantable medical device.
• the intravascular implantable device may be any one or a combination of defibrillator, cardioverter, pacemaker, monitor or drug/gene therapy delivery device and may be either a temporary or permanent device.
• the present invention comprises a method of extracting an implantable intravascular device.
• the method comprises providing an intravascular implantable device having a detachable tip assembly on one end, the tip assembly including a break-away joint releasably coupled to the device, and a tether fixedly secured to the break-away joint, the tether being secured within the vasculature by an anchor. Detaching the device from the joint allows the device to be removed, such as through an incision in a femoral vein, while the tether and joint remain anchored within the vasculature.
• the implantable intravascular device includes an extension portion between the device body and the break-away joint such that when the device is extracted, the extension portion is extracted with the device.
• FIG. 1 is a perspective illustration depicting human cardiac anatomy.
• FIG. 2 is a cross-sectional plan view of an implantable intravascular pacing device according to one embodiment of the present invention.
• FIG. 2A is a schematic representation of FIG. 2.
• FIG. 3 is a cross-sectional plan view of an implantable intravascular pacing device according to another embodiment of the present invention.
• FIG. 3A is a schematic representation of FIG. 3.
• FIG. 4 is a cross-sectional plan view of an implantable intravascular pacing device according to another embodiment of the present invention.
• FIG. 5 is a cross-sectional plan view of an implantable intravascular pacing device according to another embodiment of the present invention.
• FIG. 5 A is a schematic representation of FIG. 5.
• FIG. 6 is a cross-sectional plan view of an implantable intravascular defibrillation device according to one embodiment of the present invention.
• FIG. 6A is a schematic representation of FIG. 6.
• FIG. 7 is a perspective view an implantable intravascular defibrillation device according to one embodiment of the present invention.
• FIG. 8 is a perspective view of an anchoring arrangement according to a further embodiment of the present invention.
• FIG. 9 is an exploded view of the anchoring arrangement of FIG. 8.
• FIG. 10 is a perspective view of an anchor and cleat according to one embodiment of the present invention.
• FIG. 1OA is a closeup detail view of FIG. 10, depicting the connection between the cleat and the anchor.
• FIG. 1OB is a side plan view of FIG. 10.
• FIG. 1OC is a top plan view of FIG. 10.
• FIG. 1 1 is a cutaway view of one embodiment of an anchor arrangement implanted within a vessel.
• FIG. 12 is a cutaway view of a further embodiment of an anchor arrangement implanted within a vessel.
• FIG. 13 is a perspective view depicting an anchor arrangement according to the present invention.
• FIG. 14 is a close-up perspective view of FIG. 13.
• FIG. 15 is a perspective view of one embodiment of the present invention.
• FIG. 16 is a perspective view depicting a further anchor arrangement according to the present invention.
• FIG. 17 is a plan view of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 18 is a cross-sectional view taken along the line A-A in FIG. 17.
• FIG. 19 is a close-up view of detail area B in FIG. 18.
• FIG. 20 is an exploded view of an example embodiment of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 21 is an exploded view of detachable tip assembly components according to an example embodiment of the present invention.
• FIG. 22 is a plan view of a detachable barb tip portion according to an example embodiment of the present invention.
• FIG. 23 is a plan view of a component of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 23 A is a plan view of a component of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 23B is a plan view of a component of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 24 is a perspective view of a component of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 24A is a side view of the component in FIG. 24, in combination with an anchor.
• FIG. 25 is a cross-sectional view of a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 26 is a side perspective view of an implanted medical device having a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 27 is a close-up perspective view of an implanted medical device having a detachable tip assembly according to an example embodiment of the present invention.
• FIG. 1 the general cardiac anatomy of a human is depicted, including the heart and major vessels.
• One embodiment of the present invention describes intravascular electrophysiological systems that may be used for a variety of functions to treat cardiac arrhythmias with electrical stimulation. These functions include defibrillation, pacing, and/or cardioversion.
• the elements of an intravascular implantable device for electrophysiological therapy include at least one device body and typically, but optionally, at least one lead coupled to the body. While the present invention is directed to anchoring and retention of the device body of an intravascular implantable device, it will be understood that, in some embodiments, the one or more leads may also be anchored or retained in the vasculature or within the heart. Alternatively, the intravascular implantable device may have no leads, such as for an embodiment of an intravascular implantable drug/gene therapy device, or the one or more leads may not be anchored or retained in the vasculature or within the heart.
• intravascular implantable electrophysiology devices such as intravascular defibrillation and/or pacing devices 20 and leads 28 will be given in this description.
• reference numerals such as 20a, 20b, 20c, etc., will be used to describe certain embodiments of the intravascular device 20, whereas elsewhere reference numeral 20 may be used to more generally refer to intravascular devices of the type that may be used with the present invention for providing therapy other than, or in addition to, cardiac electrophysiology.
• reference number 28 may be used generally to refer to leads of a type that may be used with the system.
• Reference number 100 refers generally to vessels and/or vessel walls within the human body.
• device 20 includes components, known in the art to be necessary to carry out the system functions of an implantable electrophysiology device.
• device 20 may include one or more pulse generators, including associated batteries, capacitors, microprocessors, communication circuitry and circuitry for generating electrophysiological pulses for defibrillation, cardioversion and/or pacing.
• Device 20 may also include detection circuitry for detecting arrhythmias or other abnormal activity of the heart. The specific components to be provided in device 20 will depend upon the application for the device, and specifically whether device 20 is intended to perform defibrillation, cardioversion, and/or pacing along with sensing functions.
• Device 20 can be proportioned to be passed into the vasculature and to be anchored within the vasculature of the patient with minimal obstruction to blood flow.
• Suitable sites for introduction of device 20 into the body can include, but are not limited to, the venous system using access through the right or left femoral vein or the right or left subclavian vein.
• the various portions of the device 20 will be referenced to the location of those portions, the proximal portion 22, the distal portion 24 and the middle portion 26 relative to the introduction site in the femoral vein.
• Device 20 generally includes a proximal end and a distal end.
• distal portion 24 may be defined as being part of the device body, encompassing up to the distal-most third of the body of device 20.
• distal portion 24 may be defined as encompassing part of the body of device 20 and part of tether portion 52.
• distal portion 24 is defined as not encompassing the device body at all, rather it encompasses tether portion 52.
• the device 20 can have a streamlined maximum cross sectional diameter which can be in the range of 3-15mm or less, with a maximum cross-sectional diameter of 3-8 mm or less in one embodiment.
• the cross-sectional area of device 20 in the transverse direction can preferably be as small as possible while still accommodating the required components. This area can be in the range of approximately 79 mm2 or less, in the range of approximately 40 mm2 or less, or between 12.5 - 40 mm2, depending upon the embodiment and/or application.
• the cross-section of device 20 may have a circular cross-section, although other cross-sections including crescent, flattened, or elliptical cross-sections may also be used. It can be highly desirable to provide the device with a smooth continuous contour so as to avoid voids or recesses that could encourage thrombus formation on the device. It can also be desirable to provide for a circular cross-section to aid in removal or explantation of the device that more easily permits the device to be torqued or rotated during the removal or explantation to break free of any thrombosis or clotting that may have occurred.
• the cross-section of device 20 is generally isodiametric along the entirety of its longitudinal length other than for tapered portions at the proximal and distal ends of the device 20. In one embodiment, the aspect ratio of the cross-section of the device 20 to a longitudinal length of the body portion of the device 20 is less than 1 : 10 (e.g., 10mm diameter to 10 cm length) and in another embodiment is less than 1 :50.
• the housing of device 20 may be covered by an electrically insulative layer or coating such as ePTFE. It may be desirable to provide a coating that is anti- thrombogenic (e.g., perfluorocarbon coatings applied using supercritical carbon dioxide) so as to prevent thrombus formation on device 20. It may also be beneficial that the coating have antiproliferative properties so as to minimize endothelialization or cellular in growth, since minimizing growth into or onto device 20 will help minimize vascular trauma when the device is explanted. The coating may thus also be one which elutes anti-thrombogenic compositions (e.g., heparin sulfate) and/or compositions that inhibit cellular in growth and/or immunosuppressive agents.
• anti-thrombogenic compositions e.g., heparin sulfate
• one or more leads 28 may extend from device 20 proximate any of the various portions 22, 24 and 26 of the device 20. In the embodiment shown in FIGS. 2, 3, and 6, for example, a single lead 28 is shown, extending from the proximal end 22 of device 20.
• a lead 28 includes one or more electrodes, such as tip electrodes, ring electrodes, or defibrillation electrodes. In embodiments having a tether portion 52, a lead 28 may be included within tether portion 52.
• two leads 28 may extend from opposite ends of device 20, or they may extend from the same end of the device 20, such as depicted in FIGS. 4-5. Either or both of the leads may be equipped to sense electrical activity of the heart. Monitoring of the heart's electrical activity is needed to detect the onset of an arrhythmia. Activity sensed by the sensing electrode(s) is used by device 20 electronics to trigger delivery of a defibrillation shock that in one embodiment may be delivered via lead 28 having a defibrillation electrode or delivery of a pacing impulse that in one embodiment may be delivered via lead 28 via a pacing electrode.
• the lead 28 may be a conventional defibrillation/pacing lead, although alternative lead configurations may be desirable if warranted by the desired placement of the device 20 and lead within the body.
• An optimal lead will preferably give the physician implanting the device flexibility to position the device at an appropriate location in the chosen vessel without concern that the leads extending from the device will not reach their intended location.
• the lead may include a coiled section that is similar to the configuration of a coiled telephone cord. A coiled section can allow elongation of the effective length of the lead when tension is applied to the coil.
• the coiled section or any alternate type of yieldable lead section may be a plastically deformable metal or polymer that will retain its extended configuration after it has been stretched to that configuration. Other configurations that will allow additional lead length to pull out from the device if needed may also be used.
• the lead may include a helical screw-in tip or be of the tined variety for fixation to the cardiac tissue.
• a detachable screw-in lead tip may be provided, which allows the lead tip to be left within the chamber of the heart when lead 28 is extracted.
• Lead 28 may have a steroid-eluding tip to facilitate tissue in-growth for fixation purposes, or may include non-thrombogenic and/or non-proliferative surfaces or coatings similar to those as may be applied to device 20.
• lead 28 may include a coating that is anti- thrombogenic (e.g. perfluorocarbon coatings applied using supercritical carbon dioxide) so as to prevent thrombus formation on the lead. It is also beneficial for the coating to have antiproliferative properties so as to minimize endothelialization or cellular ingrowth, since minimizing growth into or onto the lead will help minimize vascular trauma when the device is explanted.
• the coating may thus also be one which elutes anti-thrombogenic compositions (e.g. heparin sulfate) and/or compositions that inhibit cellular in-growth and/or immunosuppressive agents.
• the term "lead” is used to mean an element that includes conductors and electrodes in an elongated, sealed and insulated protective configuration that is adapted to withstand chronic implantation and is generally floppy in flexibility to permit the electrodes to be positioned somewhat remotely from the circuitry that energizes the electrodes via the conductors.
• the lead 28 may be integrated with the device body, or attachable to the device body in situ or prior to implantation, or the lead 28 may be integral with the device body as an extension of the device itself.
• leads may include elements that are simply extensions or tapers of the device 12a itself (such as the portion of the device 12a at which electrodes 22a are located) as well as more conventional leads.
• More than one lead 28 may be provided, and leads may be included on the proximal/inferior end of the device body, on the distal/superior portion of the device body, generally on the device body, and/or any combination thereof.
• an end of the device body may be modified to include a stepped portion proximate the lead connection, such as on the proximal end of the device. The stepped portion allows a smooth transition between the exterior surface of the lead and the device body.
• FIGS. 2-6A Examples of devices having space efficient arrangements of their contents are shown in FIGS. 2-6A.
• One example is identified by reference numeral 20a in FIG. 2.
• One embodiment of device 20a includes one or more elongate housings or enclosures 32 depicted in cross-section in FIG. 2A to allow the components housed within it to be seen.
• enclosure 32 is a rigid or semi-rigid housing preferably formed of a material that is conductive, biocompatible, capable of sterilization and capable of hermetically sealing the components contained within the enclosure 32.
• a material is titanium, although other materials may also be used.
• components 34a are associated with delivery of a defibrillation pulse via a lead 28 (FIG. 6), whereas components 34b are associated with the sensing function performed using sensing electrodes on the defibrillation lead, on a separate lead 28 (e.g., FIGS. 4 and 5 ), or on the device body itself. Isolating components 34a from components 34b may be desirable if noise generated by the high voltage defibrillation circuitry 34a during charging might interfere with performance of the sensing circuitry 34b, or if practical limitations exist with respect to circuit interconnects 42.
• Device 20a further includes one or more batteries 36 for supplying power to the device, and in some embodiments, and/or one or more exposed body electrodes 40 on an exterior surface of enclosure 32.
• One or more circuit interconnects 42 can provide the electrical coupling between the electronic components 34, one or more leads 28, electrode(s) 40, and batteries 36. Additional circuitry may be provided to facilitate recharging batteries 36.
• FIGS. 3-3A A second example of an arrangement of components for the intravascular implantable pacing device is identified by reference numeral 20b and shown in FIGS. 3-3A. As depicted in FIGS. 3-3A, the components of device 20b may be arranged in series with one another to give device 20b a streamlined profile.
• each segment may be separately enclosed by its own titanium (or similar) enclosure in the form of containers or compartments 32.
• the components within the containers 32 may be electrically connected by flexible circuit connects 42, for example.
• the containers 32 are connected using a flexible material such as silicone rubber filler to form hinge zones.
• flexible device 20 includes one or more rigid enclosures or containers 32 used to contain electronic components 34 to be implanted inside the vasculature of a patient and having the hinge zones formed of a bellows arrangement 48.
• Containers 32 can be of any appropriate shape, cross-section, and length, but in this example are shown to have a cylindrical shape with a diameter of approximately 3-15mm and a length of approximately 20mm to 75mm.
• Containers 32 can be used to house electromechanical parts or assemblies to form sophisticated implantable devices such as defibrillators, pacemakers, and drug delivery systems. Any appropriate number of these containers 32 can be combined using interconnecting bellows 48.
• Interconnecting mechanical bellows 48 can be used, to connect a number of rigid containers 32 in order to form a flexible device 20. For many devices, this will include a string of at least three containers 32.
• the aspect ratio of the cross-sectional diameter to the longitudinal length of each container is less than at least 1.5:2 (e.g., 15 mm diameter to 20 mm length) and in another embodiment the aspect ratio is at least 1 :4.
• the bellows 48 can be of any appropriate shape, but can preferably have a shape similar in cross-section to the cross-section of the container, in order to prevent the occurrence of edges or ridges that can give rise to problems such as the formation of blood clots in the vasculature.
• the bellows can be made of a biocompatible material similar to the containers. Any coatings used for electrically insulating the containers and/or making the containers more hemo-dynamically compatible also can be used with the bellows. In addition to the ability of the bellows 48 to bend away from the central or long axis of device 20, the bellows 48 also allow for flexibility along the central axis of the device.
• shock absorption in the long axis as well as 3- dimensional flexing. Shock absorption can help to protect device 20 and internal components during the implant process by minimizing the motion of the implanted device. Further, shock absorption can provide a 1 : 1 torque ratio for steering during the implant process. The shock absorption also can help during the life of device 20, as the natural movement of the body of a patient can induce some stress on the device 20.
• Device 20c is similar to the embodiment depicted in FIGS. 3-3A, however device 20c includes multiple leads 28 on the proximal portion 22 of device 20c.
• FIGS. 6-6A another embodiment of the device identified by reference numeral 2Od is depicted.
• Device 2Od is an intravascular implantable defibrillation device, having a lead 28 adapted to inserted into the right ventricle of a patient.
• Device 2Od further includes one or more sensing electrodes, which may be located on the exterior of enclosure 32, similar to body electrodes 40.
• Device 2Od also includes one or more defibrillation electrodes on the exterior of enclosure 32.
• the device is preferably able to communicate via wireless telemetry to an instrument outside of the patient's body.
• This is commonly referred to as device interrogation and/or programming and allows the physician to monitor the state and performance of the device. It also allows the physician to reconfigure the device in the case of programmable settings.
• the circuitry used for device interrogation and/or programming can be included in all of device 20 embodiments, with the device telemetry antenna either encapsulated within the device enclosure or as part of the tether potion 52 discussed in more detail below.
• the circuitry may include a circuit that will respond in the presence of a magnetic field, electric field, a near-field or a far-field, all which are features also known in the implantable device industry.
• the communication techniques are intended to allow device 20 to communicate the device's status to the physician.
• the status information may include the state of the battery system, and whether or not a therapeutic energy delivery had occurred or not.
• the communication might also identify the parameters device 20 used, including stored electrograms, to allow reconstruction of the delivery episode by the instrument.
• the telemetry feature may also be used to program certain features governing function of device 20, such as the threshold heart rate in beats per minute which, when detected by the device, will cause the device to provide appropriate energy therapy.
• distal portion 24 of device 20 includes a tether portion 52.
• device 20 is routed through the inferior vena cava 103b, through superior vena cava 103a, and then on to one of a number of locations superior to the superior vena cava 103a as will be described.
• Device 20 is then anchored within the vasculature using an anchor 50.
• Anchor 50 is configured to retain device 20 within a patient's vasculature, and in one embodiment anchor 50 comprises a conventional intravascular stent.
• the anchor 50 may include features that give some structural stability to cause the anchor to radially support device 20 against a vessel wall 100.
• a mesh or other framework formed of shape memory (e.g., nickel titanium alloy, nitinol or shape memory polymer) elements or stainless steel wires may be used to form anchor 50.
• the anchor 50 is provided with a smooth polymeric barrier that is both antiproliferative and anti-thrombogenic and that thereby prevents endothelial growth and thrombus formation on the anchor.
• polymeric barrier examples include, but are not limited to ePTFE, or other fiuoropolymers, silicone, non-woven nylon, or biomimetic materials.
• the polymeric barrier is preferably formed by layers of barrier material on the interior and exterior surfaces of the framework, although it will be appreciated that the framework and barrier may be combined in a variety of ways to prevent thrombus formation and endothelialization on the anchor walls.
• the anchor material could include surfaces for eluting non-coagulative, anti-platelet (e.g. IIBIIIA glycoprotein receptor blockers), anti-proliferative, and/or anti-inflammatory substances.
• the anchor relies solely on a non-biological fixation to secure the anchor within the vessel, such as mechanical fixation by the radial expansion force of an anchor 50 or hooking, latching, catching or cleating the anchor 50 with respect to the vessel.
• the mechanical fixation may be augmented with by a glue or other non- biological adhesive interfaced between the anchor and the vessel which for purposes of the present invention would be considered part of a non-biological, as opposed to biological, fixation of the anchor.
• the fixation of the anchor may be accomplished solely by a glue or other non-biological adhesive interfaced between the anchor and vessel.
• the anchor may eventually rely on biological fixation such as from endothelialization or thrombus formation to assist in retaining the anchor within the vessel in addition to the initial non-biological fixation at the time of implantation.
• device 20 may generally be anchored by active or passive means.
• tether portion 52 may be secured by being “sandwiched" between a vessel wall 100 and anchor 50, as depicted in FIG. 1 1.
• tether portion 52 may be secured by a mechanical coupling with anchor 50, such as depicted in FIGS. 8 and 12.
• Anchor 50 may be separate from tether portion 52, although in one embodiment anchor 50 may also be integrated with tether portion 52. In an alternate embodiment, anchor 50, either integrated or separable, may be used to secure the body of the device 20 at the distal portion 24, where the body does not include a unique tether portion 52. In one embodiment, the tether portion 52 is selectively detachable from the body of the device 20 to facilitate extraction and/or explantation of the device 20. Device 20 is preferably able to communicate via wireless telemetry to an instrument outside of the patient's body and in one embodiment, tether portion 52 may include an internal antenna to facilitate device interrogation and/or programming. In another embodiment, the internal antenna is not within detachable portion 52.
• tether portion 52 is preferably of a smaller diameter than device 20. Minimizing the diameter of tether portion 52 is desirable so as to reduce bulging and/or irritation of the vessel 100.
• tether portion 52 is sufficiently flexible to allow bending during implantation, yet is more rigid than the floppy flexibility of leads 28.
• tether portion 52 includes a retention tip 60, which is configured to prevent tether portion 52 from being pulled out from anchor 50. Tip 60 functions as a stop, interfering with the distal end of anchor 50 and preventing tether 52 from being pulled out from between anchor 50 and vessel wall 100.
• tether portion 52 may include an electrode for defibrillation, pacing, or sensing of cardiac electrical activity. The use of an electrode positioned in tether portion 52 may be especially useful for defibrillation to generate a shock vector across the heart.
• FIGS. 8-lOC and 12 one embodiment of a tether portion 52 is depicted.
• Tether 52 is coupleable to a device 20, and may include a passage suitable for insertion of a guidewire to assist in implantation.
• tether 52 may also include an antenna for communication purposes.
• a cleat 90 is depicted, being configured to couple to tether 52 and an anchor 50.
• Cleat 90 includes one or more features for coupling to anchor 50, such as clips 92 which are configured to interact with the mesh features of anchor 50.
• One or more fins 93 are disposed on the cleat body.
• a platform area 94 may be provided on cleat 90, the platform providing a suitable surface for deploying a self-expanding anchor therefrom during implantation.
• Cleat 96 also may include a connection point for coupling to tether 52, and includes one or more attachment features 96.
• Cleat 90 may be configured to be removably coupled to tether 52, or integrated therewith, or may be molded to tether 52, or other connection arrangements as will be appreciated by one skilled in the art.
• cleat 90 is configured to correctly orient the cleat during implantation such that engagement of anchor 50 is easy to achieve.
• the placement of clips 92 and fins 93 act together, such that when cleat 90 is in a target vessel, any rotational orientation of the cleat will result in one of clips 92 being able to be engaged with anchor 50.
• cleat 90 may be adapted to couple to a strut 51 of stent 50.
• device 20 is implanted by making an incision in the patient's femoral vein, and inserting an introducer sheath through the incision into the vein.
• the introducer sheath keeps the incision open during the procedure, and includes a seal adapted to prevent blood from exiting the body while allowing the insertion of various tools and devices into the body.
• Device 20 may be introduced in a number of ways.
• the device 20 may be introduced by an over-the-wire technique.
• the distal end or distal portion of device 20 is provided with a passageway configured to receive a guidewire, and the device is slid onto the guide wire, then the distal end of device 20 is introduced through the seal.
• Device 20 is guided through the vasculature of the patient, into the inferior vena cava, then the superior vena cava, and into the subclavian vein or other vessel superior to the heart.
• a device delivery catheter may be used to facilitate introducing the device.
• Anchor 50 is introduced.
• Anchor 50 may be inserted through the seal in the femoral incision used to implant device 20.
• anchor 50 is inserted from another incision such as through an incision closer to the location of tether portion 52.
• anchor 50 may be introduced after device 20 has been positioned at the desired location within the vessel. In another embodiment, anchor 50 may be introduced prior to device 20 being introduced.
• anchor 50 may be delivered over the guide wire, such as with an anchor delivery catheter.
• Anchor 50 compressed to a streamlined position, is passed through the vasculature and approaches the distal portion of the device where the anchor will interfere with where the wire enters the tip of the device.
• the guide wire must be removed from the device and guided around the tip of the device to provide a path for the anchor.
• the anchor is then guided around the device and past the distal-most portion of the device tip.
• Anchor 50 may be self-expanding and/or it may be expanded using an inflation tool such as a balloon passed into the anchor's central lumen and subsequently inflated.
• anchor 50 When anchor 50 is expanded, its radial forces engage tether portion 52 and secure tether portion 52 against vessel wall 100, as depicted in FIG. 1 1. Depending on the characteristics of anchor 50, the expansion force of the anchor against tether portion 52 may cause the vessel wall 100 to bulge outwardly. Alternatively, the anchor 50 may deform around the shape of tether portion 52, leaving vessel 100 at its normal shape. In another embodiment, both anchor 50 and vessel 100 deform to accommodate tether portion 52. It is desirable to minimize the diameter of tether portion 52, to minimize deformation of anchor 50 and/or vessel 100.
• anchor 50 in its compressed state is guided proximate platform 94 of cleat 90.
• a sheath holding the anchor compressed is released, allowing the anchor to radially expand into the vessel.
• Cleat 90, coupled to device 20 via tether 52, is sandwiched between deployed anchor 50 and vessel wall 100.
• device 20 is manipulated, such as by its proximal end, so that cleat 90 is pulled into anchor 50.
• Clip 92 is then secured onto the mesh of anchor 50, such as depicted in FIGS. 8, 10 and 1OA.
• Device 20 is then secured in the vasculature.
• a cutaway view of cleat 90 secured to anchor 50 in a vessel 100 is depicted in FIG. 12.
• suitable locations for anchoring device 20 are referred to as superior (i.e., generally above the heart in a direction toward the head) for purposes of describing the various embodiments of the present invention in that these locations are superior of the heart and in some embodiments superior of the superior vena cava 103a.
• a suitable superior anchoring location proximate a distal portion of the device 20 effectively permits the remainder of device 20 to float, rather than lay, within the vasculature.
• suitable superior locations for anchoring the distal portion of device 20 include the right or left innominate (brachiocephalic) veins 105a or 105b, the right or left subclavian veins 102a or 102b, the right or left cephalic veins 109a or 109b.
• brachiocephalic veins 105a or 105b are veins within the torso where alternative venous drain routes will exist in the event of fibrosis and/or stenosis proximate the anchoring location.
• Suitable superior anchoring locations further tend to provide for easier bailout in the event of a problem with device 20 requiring explantation by virtue of easier surgical accessibility.
• all of these locations create an effective anchoring location that is generally oriented transverse to the general direction (in a standing human patient) of gravitational force or drop force on the portion of the device 20 that may reside within the vena cava.
• the generally transverse orientation to the direction of gravitational or drop force afforded by these locations aids in dissipating these forces without dislodging the anchor 50.
• the distal portion of device 20 potentially could be anchored in the left internal jugular vein 106b or the right internal jugular vein 106a
• these veins are less medically desirable locations because the veins are located generally outside the torso and in the neck and therefore will have more potential complications in the event of fibrosis and/or stenosis proximate the anchoring location.
• the right internal jugular vein 106a is also a less desirable anchoring location due to the challenges associated with drop tests. Similar to the problems associated with anchoring the device lower in the torso, anchoring the present invention in the right internal jugular vein 106a may not adequately secure the implantable device during drop tests that simulate the effect of a patient falling or jumping.
• a first suitable superior anchor location is proximate the subclavian crush zone 1 1 1 , which is defined as the region of the right subclavian vein 102a or left subclavian vein 102b that can be compressed between a patient's clavicle and first rib due to upward movement of the patient's arm.
• the object can become damaged, potentially leading to failure of the object or damage to the vessel. This problem is compounded if multiple leads or other intravascular devices are located within the crush zone, as there is a tendency for the leads and/or devices to abrade one another, resulting in an increased potential for failures of the leads and/or devices.
• device 20 is positioned proximate subclavian crush zone 1 1 1, while tether portion 52 extends across and through the crush zone, and is secured with an anchor 50 located beyond and peripheral of subclavian crush zone 1 1 1 , as depicted in FIGS. 13-15.
• a second suitable superior anchor location is within the right 105a or left 105b cephalic veins, as depicted in FIG. 16.
• device 20 is generally positioned proximate subclavian crush zone 11 1, while tether portion 52 extends across and through the crush zone, and into the cephalic vein. Tether portion 52 is secured with an anchor 50 in the cephalic vein.
• Detachable tip assembly 30 comprises a tether 52, a breakaway joint 54, and an optional extension portion 56.
• Detachable tip assembly 30 is coupled to device 20 with connector 58.
• detachable may comprise severable, releasable, or otherwise removable.
• Tether 52 includes a tip portion 60, an optional locator ring 62, a connector portion 64, a lumen 66, and a housing 68.
• Tip portion 60 is configured to prevent tether 52 from being pulled out from an anchor 50 (discussed in further detail below). Tip portion 60 functions as a stop, interfering with the distal end of anchor 50 and preventing tether 52 from being pulled out from between anchor 50 and vessel wall 100.
• a locator ring 62 is optionally included on tip portion 60, and is configured to assist the implantation of device 20 by providing increased visibility of tether 52 in fluoroscopy visualization.
• Connector portion 64 is adapted to couple tether 52 to break-away joint 54 such that tether 52 does not separate from joint 54.
• Housing 68 is constructed of a suitable material such as ChronoFlex polyurethane, or ElastEon.
• Lumen 66 may be configured to receive a wire 72 for steering, or for structure and shape.
• Wire 72 may be composed of surgical-grade stainless steel, a molded polymer, or other materials apparent to one skilled in the art.
• break-away joint 54 is configured to be removably coupled to extension 56, and to be non-removably coupled to tether 52. In another embodiment, breakaway joint 54 is configured to be removably coupled directly to device 20. Joint 54 may comprise a snap-fit, a threaded joint, or other similar configurations. One type of materials for joint 54 include surgical-grade stainless steel.
• Extension portion 56 is optionally included in detachable tip assembly 30.
• Extension 56 comprises a housing 78, constructed of a suitable material such as ChronoFlex polyurethane, or ElastEon.
• Housing 78 is adapted to hold various components such as an antenna 74, or a lead 28 (not shown) for defibrillation, pacing, or sensing of cardiac electrical activity.
• the use of a lead in extension 56 may be especially useful in defibrillation to generate a shock vector across the heart.
• device 20 is preferably able to communicate via wireless telemetry to an instrument outside of the patient's body.
• an antenna 74 may be provided within housing 78 to facilitate device interrogation and/or programming.
• An antenna isolation sleeve 80 may surround antenna wire 74.
• Antenna wire 74 may engage break-away joint 54, as depicted in FIG. 19.
• Extension housing 78 is adapted to non-removably couple joint 54, and may be coupled to joint 54 by adhesive, welding, soldering, or other suitable methods. Housing 78 may also be molded directly onto joint 54.
• Extension portion 56 is particularly useful when it is desired to anchor device 20 within a patient's subclavian region, such as in the subclavian vein or cephalic vein.
• device 20 is routed through the vena cava and up to the subclavian crush zone 1 1 1, which is defined as the region of the left (or right) subclavian vein that can be compressed between a patient's clavicle and first rib, due to upward movement of the patient's arm.
• the object can become damaged, potentially leading to failure of the object or damage to the vessel. This problem is compounded if multiple leads or other intravascular devices are located within the crush zone, as there is a tendency for the leads and/or devices to abrade one another, resulting in an increased potential for failures of the leads and/or devices.
• device 20 is positioned proximate subclavian crush zone 1 1 1 while extension portion 56 extends across and through the crush zone.
• Tether 52 is secured with an anchor 50 located beyond and peripheral of subclavian crush zone 1 1 1 , for example as depicted in FIGS. 26 and 27.
• anchor 50 may secure tether 52 within the patient's cephalic vein.
• FIGS. 24 and 24A an embodiment of a detachable tip assembly 30b and its components is depicted, including a tether 52 having a tip portion 60, a plurality of barbs 70 disposed on the outer surface of a housing 68, a connector 64 and a lumen 66.
• Barbs 70 comprise structural features for anchor 50 to grip against, increasing the holding strength of tether 52 by anchor 50.
• Connecter 64 is configured to releasably couple tether 52 to device 20, such that the force required to separate device 20 from tether 52 is less than the force required to tear tether 52 from anchor 50.
• the distance between barbs 70 may be adjusted according to the design on anchor 50.
• Detachable tip assembly 30c includes a tether portion 52 having a tip portion 60, and a sleeve 82.
• Tether portion 52 is non-removably coupled to device 20, and tether 52 is of a smaller diameter than device 20, as with the other embodiments discussed above.
• Sleeve 82 may be integrated with an anchor 50, or may be separable from the anchor. Sleeve 82 is preferably sandwiched between an anchor 50 and a vessel wall 100.
• Sleeve 82 may be constructed of a molded polymer, for example, or other biocompatible materials apparent to one skilled in the art.
• Sleeve 84 includes at least one structural retention feature 84. As depicted in FIG. 25, an anchor 50 is configured to engage sleeve 82 between the two structural retention features 84, insuring sleeve 82 is held firmly in place.
• Sleeve 82 is configured to releasably receive tether 52 therein. Tether 52 is detachable from sleeve 82, although sleeve 82 features an inner profile configured to secure tether 52 during normal use by a patient.
• a detachable tip assembly 30d may also be comprised of the arrangement in FIGS. 8-9, including a tether 52 and a cleat 90.
• tether 52 is detachable from the device body.
• cleat 90 may be detachable from tether 52.
• Cleat 90 includes one or more clips adapted for mechanically securing cleat 90 to an anchor 50.
• anchor 50 it is configured to releasably retain device 20 within a patient's vasculature such as in a subclavian vein, cephalic vein, jugular vein, or in the superior vena cava.
• anchor 50 comprises a conventional intravascular stent.
• Tether 52 may be secured by being “sandwiched" between a vessel wall 100 and anchor 50.
• anchor 50 is separable from tether portion 52, although anchor 50 may also be integrated with tether portion 52.
• Detachable tip assembly 30 is preferably of a smaller diameter than device 20.
• extension portion 56 is a smaller diameter than device 20, and tapers down to a still further diameter to match the diameters of joint 54 and tether 52, as best depicted in FIGS. 17-
• tether 52 may be desirable so as to reduce bulging and/or irritation of the vessel wall 100.
• tether 52 is likely shorter in length than the defibrillator.
• tether 52 may be shorter than, longer than, or similar in length to, the pacemaker.
• Tip assembly 30 may be somewhat flexible to allow bending during implantation, yet is also somewhat rigid.
• tether 52 includes a wire 72 that provides rigidity.
• Retention tip 60 on tether 52 is configured to prevent tether 52 from being pulled out from anchor 50.
• Tip 60 functions as a stop, interfering with the distal end of anchor 50 and preventing tether 52 from being pulled out from between anchor 50 and vessel wall 100.
• suitable locations for anchoring device 20 can include, but are not limited to, inferior vena cava 103b, superior vena cava 103a, either subclavian vein, either innominate/brachiocephalic vein, either jugular vein, and either cephalic vein.
• Detachable tip assembly 30 may be located on distal portion 24 of device 20, or on proximal portion 22.
• Tip assembly 30 includes an extension portion 56 between device body 20 and detachable tether portion 52.
• An anchor 50 is secured within left subclavian vein 102b. It will be appreciated that although not pictured, tether portion 52 could be made longer so as to anchor tether 52 within the patient's cephalic vein, while maintaining the location of device 20 proximate subclavian crush zone 1 11.
• Exposed body electrode regions 40 may include defibrillation electrodes and/or sensing electrodes, for example.
• the activation of body electrodes 40 may be adjusted and controlled by the various circuitry within device 20 as needed.
• the device may be cut away from the tip assembly during an intravascular procedure.
• a catheter containing a cutting mechanism is advanced through the vasculature to the desired location, and some part of the tip assembly is cut, releasing the device.
• the connection between the device and the tip assembly is designed such that if a sufficient pull force is exerted on the device, the device will separate from the tip assembly.
• a suitable force required to separate the device and tip assembly should be large enough to not allow the device to accidentally separate from the tip assembly, yet low enough to disengage the connection rather than damage the anchor's fixation in the vessel.
• connection between the device and the tip assembly may be threaded, with one component serving as a screw and the other component the threaded bore. Rotation of the device, such as by a grasper on the distal end, may separate the device and tip assembly, allowing removal of the device.
• one or more magnets are provided in the device and/or tip assembly to connect the device and tip assembly. The one or more magnets may be rotatable, such that causing the magnet to rotate changes a magnetic attractive force between two adjacent components to a magnetically repulsive force, thereby detaching the tip assembly from the device.
• a magnet may be provided in conjunction with a mechanical fastener, such as a screw, so that by rotating the magnet causes the screw to rotate, separating the device and tip assembly.
• a motor or other motive force actuator is provided, such as in the tip assembly.
• the motor or motive force actuator may be coupled to a screw, and powering the motor results in the separation of the device and tip assembly.
• Other arrangements of detach mechanisms will be appreciated by one skilled in the art, such as quarter- or half-turn connections between the device and tip assembly, or solenoid actuators, or piezoelectric actuators.
• pronged or spring-loaded clips may be engaged or disengaged to effect a release of the detachable tip.
• Such implants might include, for example, implantable neurostimulators, artificial pancreas implants, diagnostic implants with sensors that gather data such as properties of the patient's blood (e.g. blood glucose level) and/or devices that deliver drugs or other therapies into the blood from within a blood vessel.
• implantable neurostimulators e.g., artificial pancreas implants
• diagnostic implants with sensors that gather data such as properties of the patient's blood (e.g. blood glucose level) and/or devices that deliver drugs or other therapies into the blood from within a blood vessel.

Landscapes

• Health & Medical Sciences (AREA)
• Cardiology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Electrotherapy Devices (AREA)
• Prostheses (AREA)

Applications Claiming Priority (4)

Publications (2)

Family

ID=39492858

Family Applications (1)

Country Status (2)

Families Citing this family (11)

Citations (3)

Family Cites Families (6)

• 2007
  • 2007-12-04 EP EP07862549A patent/EP2097042A4/de not_active Withdrawn
  • 2007-12-04 WO PCT/US2007/024912 patent/WO2008070120A2/en active Application Filing

Patent Citations (3)

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events