WO2024216051A1 - Facial vein access for intravascular devices and methods for baroreflex activation - Google Patents

Abstract

The present disclosure relates in part to devices and methods for facial vein access in a patient for baroreflex activation at a target location. For example, the present disclosure provides a method of implanting a baroreflex activation device within a patient. The method includes the steps of accessing, by an implantation procedure, a target location proximate a facial vein of the patient, introducing, by a delivery device, an electrode structure of the baroreflex activation device to the target location, verifying placement of the electrode at the target location by applying one or more electrical stimulations to the target location, and controlling the implanted baroreflex activation device to stimulate baroreceptor activation in the patient using the electrode structure. Embodiments disclosed herein provide improvements to baroreflex activation therapy by enabling implantation through patient vasculature, for example using contralateral and ipsilateral implant procedures to access a target location for baroreceptor therapy.

Description

Attorney Docket No.40013-245 FACIAL VEIN ACCESS FOR INTRAVASCULAR DEVICES AND METHODS FOR BAROREFLEX ACTIVATION CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 63/458,855 filed on April 12, 2023, the disclosure of which is incorporated by reference herein in its entirety. TECHNICAL FIELD The present disclosure relates generally to surgical implant methods and devices, and more particularly the present disclosure relates to improved minimally invasive methods and devices for implanting one or more components of a baroreflex activation device via intravascular access. BACKGROUND Cardiovascular disease is a major contributor to patient illness and mortality and is also a primary driver of health care expenditure. Heart failure is the final common expression of a variety of cardiovascular disorders, characterized by an inability of the heart to pump enough blood to meet a patient’s needs. Symptoms of heart failure include fatigue, reduced exercise capacity and shortness of breath. Hypertension, or high blood pressure, is a major cardiovascular disorder that is estimated to affect tens of millions of people in the United Sates alone. Hypertension is a leading cause of heart failure and stroke, is the primary cause of death for tens of thousands of patients per year, and is listed as a primary or contributing cause of death for hundreds of thousands of patients per year in the United States alone. Attorney Docket No.40013-245 Accordingly, heart failure and hypertension are serious health problems demanding significant research and development for the treatment thereof. One approach for treating hypertension and/or heart failure is baroreflex activation therapy (or “BAT”), which comprises stimulation of baroreceptors and/or associated nerves or nerve structures of a patient. Baroreceptors are sensory nerve ends that are profusely distributed within the walls of the major arteries, as well in the heart, aortic arch, carotid sinus or arteries, and in the low-pressure side of the vasculature such as the pulmonary artery and vena cava. Baroreceptor signals are used to activate a number of body systems which collectively may be referred to as the baroreflex system. Baroreceptors are connected to the brain via the nervous system. Thus, the brain is able to detect changes in blood pressure, which can be related to, or indicative of, cardiac output. Baroreflex activation therapy works by artificially activating the carotid sinus baroreflex. U.S. Patent No. 6,522,926 to Kieval, et al. discloses baroreflex activation devices, systems and methods for activating baroreceptors to regulate blood pressure for the treatment of hypertension and/or heart failure (to counteract the above-described pressor response). Generally speaking, the baroreflex activation device may be activated, deactivated or otherwise modulated to activate one or more baroreceptors and induce a baroreceptor signal or a change in the baroreceptor signal to thereby affect a change in the baroreflex system. The baroreflex activation device may be activated, deactivated, or otherwise modulated continuously, periodically, or episodically. The baroreflex activation device may utilize electrical, mechanical, thermal, chemical, or biological means, or a combination thereof to activate the baroreceptor. Baroreceptors of the patient may be activated directly, or activated indirectly for example via the adjacent vascular tissue. Attorney Docket No.40013-245 Activating the baroreflex of a patient (by, for example, stimulation of baroreceptors in the aortic arch or carotid sinus or by stimulating the nerve emanating from baroreceptors such as the aortic nerve, carotid sinus nerve or vagus nerve) increases afferent electrical signals. For example, through the carotid sinus nerve (Hering’s nerve, a branch of the glossopharyngeal nerve, cranial nerve IX) or aortic nerve (a branch of the vagus nerve, cranial nerve X) to the medullary brain centers that regulate autonomic tone. Increased afferent signals to these medullary centers cause a reduction in sympathetic tone and an increase in parasympathetic tone. This results in lower heart rate, reduced sodium and water reabsorption by the kidney resulting in a diuresis, relaxation of the smooth muscle in the blood vessels which results in vasodilatation and a reduction in excessive blood pressure, cardiac workload and circulating neurohormone levels. Thus, peripheral activation of the baroreflex results in a physiologic response whereby cardiovascular function is controlled by mechanisms determined by the integrative action of the central nervous system action on all peripheral organs and blood vessels. In hypertension clinical trials, BAT has been demonstrated to reduce excessive blood pressure. In heart failure clinical trials, BAT has been demonstrated to reduce patient symptoms, improve patient quality of life and functional capacity, improve cardiac function, decrease levels of circulating cardiac stress biomarkers, and reduce patient rehospitalization. Early approaches to BAT systems and associated implant procedures typically required relatively large incisions on one or both sides of a patient’s neck to create sufficient access to the target vasculature in the area of the carotid sinus. The carotid artery was dissected free, one or more electrode pads were wrapped around the artery and sutured in place. Current generation implantable BAT devices and systems offer pulse generator Attorney Docket No.40013-245 housings and associated therapy electrodes with reduced form factors as compared to early systems. One such system, described in U.S. Patent No. 8,437,867 to Murney et al., includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. Current generation implantable BAT devices and systems also offer improvements to the implant procedure. Smaller electrode structures typically allow smaller incisions on the patient. The electrode structure described in the above-mentioned U.S. Patent No. 8,437,867 can be implanted via a minimally invasive approach, as described therein. A recent improvement to the implant procedure for BAT devices and systems involves percutaneous, minimally invasive methods and related devices, as described in published PCT application WO 2020/037145 to Pignato et al. Some prior approaches have contemplated intravascular implantation of baroreflex activation devices, or intravascular delivery of baroreflex activation devices for extravascular implantation, or both. However, opportunities exist for improvements to prior intravascular techniques. The present disclosure addresses these concerns. SUMMARY The present disclosure provides systems and methods for treating a patient by inducing a baroreceptor signal to effect a change in the baroreflex system (e.g., reduced heart rate, reduced blood pressure, etc.). The baroreceptor signal is activated or otherwise modified by selectively activating baroreceptors. To accomplish this, embodiments of the present disclosure uses a baroreflex activation device positioned near a baroreceptor in the carotid sinus, (or, within the aortic arch, heart, common carotid arteries, subclavian arteries, Attorney Docket No.40013-245 brachiocephalic artery and/or other arterial and venous locations). In one example, the baroreflex activation device may be located in the right and/or left carotid sinus (near the bifurcation of the common carotid artery) and/or the aortic arch. By way of example, not limitation, the present disclosure is described with reference to the carotid sinus location. Generally speaking, baroreflex activation devices may be activated, deactivated or otherwise modulated to activate one or more baroreceptors or associated nerve tissues and induce a baroreceptor signal or a change in the baroreceptor signal to thereby effect a change in the baroreflex system. The baroreflex activation device may be activated, deactivated, or otherwise modulated continuously, periodically, or episodically. The baroreflex activation device may comprise a wide variety of devices which utilize electrical response (or in some instances electrically induced thermal or mechanical responses) to activate the baroreceptor. The baroreceptor may be activated directly or indirectly via the adjacent vascular tissue. The baroreflex activation device may be positioned at least partially inside the vascular lumen (i.e., intravascularly). Alternatively, the baroreceptor activation device may be positioned outside of the vascular lumen, after implantation has occurred. The procedure itself may involve entry through the vascular lumen and exiting through the adjacent wall of the vasculature to implant the device in a target area or location. In one example of the present disclosure, systems for inducing a baroreceptor signal to effect a change in the baroreflex system of a patient comprise a baroreflex activation device and a control system. The baroreflex activation device can be positioned in, or in some cases on, a blood vessel, e.g., in a vascular lumen or over an outer surface of the blood vessel proximate a baroreceptor so that activation of the device can induce a baroreceptor signal in the baroreceptor. The control system can be coupled to the baroreflex activation device and includes a processor and a memory. The memory may include software defining a stimulus or Attorney Docket No.40013-245 activation regimen which can generate a control signal as a function of the regimen. In another example of the present disclosure, a method of implanting a baroreflex activation device within a patient may include accessing, by an implantation procedure, a target location proximate a facial vein of the patient. The target location may be proximate to the carotid sinus of the patient. The method may further include introducing, by a delivery device, an electrode structure of the baroreflex activation device to the target location. The introduced electrode structure can be configured for electrical stimulation at the target location. The method may further include verifying placement of the electrode structure at the target location by applying one or more electrical stimulations to the target location, and controlling the implanted baroreflex activation device to stimulate baroreceptor activation in the patient using the electrode structure. The above-described method implanting a baroreflex activation device may be performed using a baroreflex activation system including the device, a control system, a pulse generator, and a delivery device for delivering the device into a patient. The above-described method may also be performed using a kit that includes one or more components of the baroreflex activation system and optionally additional components as needed for the implant procedure. Embodiments of the disclosure may be entirely intravascular, entirely extravascular, or partially intravascular and partially extravascular. Furthermore, baroreflex activation devices may reside wholly in or on arterial vasculature, wholly in or on venous vasculature, or in or on some combination of both. In some embodiments, for example, implantable devices may be positioned within an artery or vein, while in other embodiments devices may be placed extravascularly, on the outside of an artery or vein. In introducing and placing devices of the present invention, any suitable technique and access route may be employed. Attorney Docket No.40013-245 For example, in some embodiments an open surgical procedure may be used to place an implantable device. Alternatively, an implantable baroreflex activation device may be placed within an artery or vein via a transvascular, intravenous approach. In still other embodiments, an implantable device may be introduced into vasculature via minimally invasive means, advanced to a treatment position through the vasculature, and then advanced outside the vasculature for placement on the outside of an artery or vein. For example, an implantable device may be introduced into and advanced through the venous vasculature, made to exit the wall of a vein, and placed at an extravascular site on an artery. BRIEF DESCRIPTION OF THE DRAWINGS Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which: FIG.1 is a schematic of portions of human vasculature. FIG. 2 is a schematic of portions of human vasculature, in conjunction with a contralateral implant method, according to an embodiment. FIG. 3 is a schematic of portions of human vasculature, in conjunction with an ipsilateral implant method, according to an embodiment. FIG.4 is a flowchart illustrating a method of implanting a baroreflex activation device within a patient, according to an embodiment. FIG.5 is a block diagram of an implantable baroreflex activation system, according to an embodiment. Attorney Docket No.40013-245 While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims. DETAILED DESCRIPTION OF THE DRAWINGS The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. Embodiments of the present disclosure relate to baroreflex activation devices, systems, and associated implant methods. For information pertaining to the cardiovascular, circulatory and nervous systems, as well as baroreceptor and baroreflex therapy devices, systems and techniques that may be used in whole or in part with embodiments of the present disclosure, reference is made to the following commonly assigned published patent applications and granted patents: U.S. Published Patent Application Nos. 2006/0004417 to Rossing et al., 2006/0074453 to Kieval et al. and 2008/0082137 to Kieval et al., and U.S. Pat. Nos. 6,522,926 to Kieval et al., 6,850,801 to Kieval et al., 6,985,774 to Kieval et al., 7,480,532 to Kieval et al., 7,499,747 to Kieval et al., 7,835,797 to Rossing et al., 7,840,271 to Kieval et al., 8,086,314 to Kieval, 8,326,430 to Georgakopoulos et al., and 9,345,877 to Pignato et al., the disclosures of which are hereby incorporated by reference in their entireties. Prior intravascular implant approaches are described at least in U.S. Pat. Nos. Attorney Docket No.40013-245 7,616,997 to Kieval et al., 8,224,437 to Kieval et al., and 8,583,236 to Kieval et al., the disclosures of which are hereby incorporated by reference in their entireties. In embodiments, a baroreflex activation device may be delivered through venous (low-pressure) vasculature, positioned at a target location proximate tissue to be stimulated such as baroreceptors (or associated nerves or nerve structures), and fixed in place within a venous vessel. Electrical stimulation of proximate baroreceptors is accomplished through the venous wall, e.g., transvascularly. In other embodiments, a baroreflex activation device may be delivered through venous (low-pressure) vasculature, positioned at a target location proximate tissue to be stimulated such as baroreceptors (or associated nerves or nerve structures), then advanced through the vessel wall for placement on the outside of an artery or vein or other location, e.g., an intra-to-extravascular approach. For example, an implantable device may be introduced into and advanced through the venous vasculature, made to exit the wall of a vein, and placed at an extravascular site on an artery. While some prior intravascular implant approaches were performed using a target location in the jugular vein, some drawbacks to such techniques have been identified by the inventors of the present disclosure. For example, it has been discovered that the location or orientation of the jugular vein, especially with respect to the carotid sinus, can vary greatly among patients leading to difficulties with the implant procedure, reduced efficacy of an implanted device, or both. The jugular vein can be subject to move in conjunction with movements of a patient’s head or neck. Additionally, in some procedures the vein can become occluded from the implanted device, or can be intentionally severed and closed off as part of the procedure, which can be less desirable for the jugular vein. Selecting a target location in the jugular vein may remain a suitable option for some patients, however additional techniques are described herein. Attorney Docket No.40013-245 In embodiments, the common facial vein may be utilized as the target location for implantation of a baroreflex activation device. In embodiments, the common facial vein may be utilized as the target location for delivery of a baroreflex activation device through the wall of the vein to be implanted at an extravascular location. Referring now to FIG. 1, portions of the vasculature of a neck are depicted. The carotid bifurcation (or sinus) contains many baroreceptors within the walls of the artery. The internal jugular vein generally is oriented parallel to the common carotid artery in this region. Extending off the jugular vein is the common facial vein. The common facial vein is arranged closely to the carotid bifurcation. The orientation of the vascular structures in FIG. 1 are for illustrative purposes rather than exact anatomical representations. It should be understood that different patients may have different vasculature configurations requiring certain implantation techniques to be used over others. Referring now to FIG. 2, in one embodiment a contralateral implant procedure is depicted. Beginning by accessing the right subclavian vein, such as by Seldinger technique or other methods, a steerable catheter can be introduced and routed into the brachiocephalic veins, then turned into the left internal jugular vein, before finally entering the facial vein and reaching the target location. As depicted, access begins on the right side of the patient, although starting on the left side is also contemplated. Accessing from the right side may be advantageous when the desired implant location for the implantable pulse generator is the right side of the patient, as the electrical lead may be placed in the venous vasculature along the implant pathway and connected to the pulse generator in upper right area of the patient’s torso. In the contralateral approach depicted in FIG. 2, there are several turns required along the pathway, however the angles of such turns are relatively gradual. Referring now to FIG. 3, in one embodiment an ipsilateral implant procedure is Attorney Docket No.40013-245 depicted. Beginning by accessing the subclavian vein, such as by Seldinger technique or other methods, a steerable catheter can be introduced and then turned into the right internal jugular vein, before finally entering the facial vein and reaching the target location. The approach in FIG. 3 features fewer turns than the approach in FIG. 2, however the angle between the right subclavian vein and the right internal jugular vein is quite acute and may increase the complexity of the catheter design and method of use. While the approach in FIG. 3 could be performed starting from the left side of the patient, simplifying the turns along the implant pathway, typically implantable cardiac pacemaker and implantable cardioverter- defibrillator pulse generators are implanted in the left torso of a patient, therefore for increased compatibility of baroreflex activation systems with other devices, the right side of the patient may be more desirable for an implant location. In alternate embodiments, the techniques depicted in FIGS. 2 and 3 may be performed beginning with accessing the internal jugular vein directly. In alternate embodiments, the techniques depicted in FIGS.2 and 3 may be performed beginning with accessing the femoral vein. Irrespective of approach, once a target location in the facial vein is reached with the steerable catheter (or other suitable tools), an electrode structure may be introduced, for example over a guidewire or via a lumen of the catheter, or other techniques. In an embodiment, the electrode structure may be implanted intravascularly, such as in the facial vein. One or more test stimulations may be conducted to verify placement or alignment of the electrode structure with respect to the baroreceptors in the nearby carotid sinus, or to limit extraneous stimulation, or both. In embodiments, the electrode structure may include radiopaque markers to assist with visualization under fluoroscopy. In another embodiment, the electrode structure may be implanted extravascularly, for Attorney Docket No.40013-245 example on the carotid sinus. One or more tools may be advanced to the target location, the vein occluded, and an incision made in the venous wall. An electrode structure may then be advanced to the target location, passed through the incision in the vein, and advanced out of the vein toward the carotid sinus. In embodiments, electrode structure arrangements according to the present disclosure may be configured for intravascular or extravascular implantation. Electrode structures may be unipolar (monopolar), bipolar, multi-electrode arrays, patch-type, stent-like, or other, as described in the patents and patent applications previously incorporated by reference herein. In an embodiment, an implantable pulse generator may be provided having a form factor suitable for chronic implantation within the vasculature. Such form factor may be selected to minimize vessel blockage and preserve normal blood flow. In an embodiment, an anchor may be provided to retain the pulse generator within the vessel, for example an expandable stent-like structure. In an embodiment, the pulse generator may be implanted within the jugular vein, with a pigtail type lead extending into the facial vein. In an embodiment, the associated electrode structure may be implanted within the facial vein. In another embodiment, the electrode structure may be passed through the wall of the facial vein for implant on the nearby carotid sinus. In an embodiment, the electrode structure and pulse generator are coupled via wireless connection, allowing the electrode structure to be implanted in a variety of locations. In embodiments, the pulse generator may include a primary cell power source, or a rechargeable power source, or be externally powered. Referring now to FIG. 4, a method 10 of implanting a baroreflex activation device within a patient is illustrated according to an embodiment of the disclosure. The method may include the steps of accessing, by an implantation procedure, a target location proximate a facial vein of the patient (12). In an embodiment, the target location can be proximate the Attorney Docket No.40013-245 carotid sinus of the patient. In another embodiment, the target location can be directly on the carotid sinus rather than proximate to the sinus. The implantation procedure may use a steerable catheter or a similar implantation device to access the target location. In embodiments, the implantation procedure may be a contralateral implant procedure as discussed with respect to FIG. 2, or an ipsilateral implant procedure as discussed with respect to FIG.3. If the contralateral implant procedure is used, the method of implanting a baroreflex activation device may further include the steps of first accessing a right subclavian vein of the patient, followed by accessing brachiocephalic veins of the patient, and followed by accessing the left internal jugular vein of the patient, before finally accessing the target location proximate the facial vein of the patient. If the ipsilateral implant procedure is used, the method of implanting a baroreflex activation may further include the steps of first accessing the right subclavian vein of the patient, followed by accessing the right internal jugular vein of the patient, before finally accessing the target location proximate the facial vein of the patient. Irrespective of which implant procedure is used, these steps can be performed using a steerable catheter or a similar implantation delivery device directed through the patient veins to the target location as discussed. In an embodiment, accessing the target location may include the step of puncturing an opening through the facial vein to gain access to the target location which can be proximate to the carotid sinus. The method illustrated in FIG. 4 may further include the step of introducing, by a delivery device which may be a catheter, an electrode structure of the baroreflex activation device to the target location (14). The electrode structure can be configured for electrical stimulation of the target location to stimulate baroreceptor activation in the patient. The electrode structure may comprise any of the designs or configurations described herein or Attorney Docket No.40013-245 those described in any of the commonly assigned published patent applications and issued patents incorporated by reference herein. In an embodiment, the baroreflex activation device and/or the electrode structure may be communicatively couplable to an internal pulse generator separately implanted within the patient, or to an external pulse generator located outside the patient but in close proximity to the device. In an embodiment, the baroreflex activation device and/or the electrode structure may be communicatively couplable to a control system configured to provide instructions related to stimulation of the baroreflex for baroreceptor activation. The method illustrated in FIG. 4 may further include the step of verifying placement of the electrode structure at the target location (16). In an embodiment, placement verification may be achieved by applying one or more test electrical stimulations to the target location and measuring the response of baroreceptor activation in the patient. Alignment of the electrode structure with respect to baroreceptors in the nearby carotid sinus may also be verified at the same time as placement verification. Alignment verification refers to the electrode structure covering enough baroreceptors to provide effective baroreflex activation therapy to the patient. In an embodiment, placement and alignment of the electrode structure may be verified using a visualization technique such as fluoroscopy. The electrode structure may have one or more visual identifiers, such as radiopaque markers, to assist with visualization. In other embodiments, placement and alignment may be verified using other techniques such as electrical signal response, physical inspection of the patient, and biochemical response of the patient after receiving the implanted device, for example. After verifying adequate implantation at the target location, the method illustrated in FIG.4 may further include the step of controlling the implanted device to enable baroreceptor activation in the patient via electrical stimulation by the electrode structure (18). The Attorney Docket No.40013-245 electrical stimulation properties of the implanted device may be controlled in various ways based on the condition to be treated and the stage of the condition (e.g., stage A, B, C, or D heart failure). For example, different electrical stimulation properties may be used to treat stage C heart failure, characterized as having current or previous symptoms of heart failure, compared to treating stage D heart failure which is characterized as heart failure symptoms that interfere with daily life functions and/or lead to repeated hospitalizations. In an embodiment, control of the implanted device may be achieved using an external control system electrically coupled to the device. Example control systems compatible with the present disclosure include those described in commonly assigned U.S. Patent Nos. 8,880,190 and 8,755,907 to Kieval et al., the disclosures of which are hereby incorporated by reference in their entireties. Access to the target location using the method of FIG. 4 may be alternatively achieved by entering the internal jugular vein or the femoral vein directly, rather than first entering a subclavian vein as described previously. This can prove difficult given the variability in location of the jugular vein for different patients, but may prove more suitable with the femoral vein for certain patients. In other embodiments, the target location for implantation of the baroreflex activation location may be located proximate the internal jugular vein. The previously described steps of introducing an electrode structure to the target location, verifying placement of the electrode structure at the target location, and controlling the implanted device, can be performed in the same manner using this alternative access approach. In other embodiments, the electrode structure may comprise an anode positioned at or near the carotid sinus, and a cathode positioned at or near the jugular vein. The electrical field created by this arrangement can be used for baroreflex activation therapy as described herein. Attorney Docket No.40013-245 Further reference to this arrangement is provided in commonly assigned U.S. Patent No. 7,616,997 to Kieval et al, previously incorporated by reference in its entirety. Alternatively, the cathode of the electrode structure can be positioned at other locations proximate to the anode, such as at or near the facial vein. The facial vein is proximally closer to the target location positioned at or near the carotid sinus and thus would create a stronger electrical field given the reduced distance between the anode and cathode. Referring now to FIG. 5, an implantable baroreflex activation system 20 may include a control system 22, a pulse generator 24, a baroreflex activation device 26 having an electrode structure 28 configured to provided electrical stimulation, and a delivery device 30 for delivering the baroreflex activation device 26 into a patient. An example baroreflex activation system 20 is provided in commonly assigned U.S. Patent No. 8,437,867 to Murney et al., previously incorporated by reference in its entirety. System 20 may comprise other non-depicted components such as a housing for one or more of the components, a sensor positioned in the patient, an electrical lead, and an anode and a cathode as the electrode structure, for example. The baroreflex activation device 26 can be positioned in, or in some cases on, a blood vessel, e.g., in a vascular lumen or over an outer surface of the blood vessel proximate a baroreceptor so that activation of the device can induce a baroreceptor signal in the baroreceptor. In embodiments, baroreflex activation device 26 can be positioned on or near a target location as discussed with respect to method 10 illustrated by FIG. 4. The control system 22 can be couplable to the baroreflex activation device 26 and can include a processor 32 and a memory 34. The processor 32 is generally configured to provide instructions and processing power to the control system 22 to perform its controlling function. The memory 34 may include software defining a stimulus or activation regimen which can generate a Attorney Docket No.40013-245 control signal as a function of the regimen for use by the baroreflex activation device 26. In operation, implantable baroreflex activation system 20 may be delivered into a patient and used for electrical stimulation of patient baroreceptors using the steps of method 10. In an embodiment, baroreflex activation system 20 can be provided to a patient or a doctor in a kit (not depicted). The kit may include the components of system 20, namely the control system 22, the pulse generator 24, the baroreflex activation device 26 with electrode structure 28, and the delivery device 30. One or more of the kit components may be contained in hermetically sealed and sterilized packages for safe storage and transport of the kit in a medical setting. The kit may be transported from an assembly facility to a medical setting such as a hospital for use with a patient as described herein. The kit may include instructions for operating baroreflex activation system 20, such as the steps of method 10 and other useful design and operating information. The instructions may include additional information about system 20 such as information about implanting the electrode structure 28 at a target location, information about programming or operating the control system 22 and the pulse generator 24, and other information relevant to a patient and a doctor performing the implantation. In an embodiment, the kit may include each component of system 20 except for the delivery device 30 which may already be supplied to the medical setting where kit is delivered to (i.e., in an embodiment, delivery device 30 may be reusable so it need not be included in every kit for system 20). Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed disclosure. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, Attorney Docket No.40013-245 configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed disclosure. Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. For purposes of interpreting the claims, it is expressly intended that the provisions of Attorney Docket No.40013-245 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.

Claims

Attorney Docket No.40013-245 CLAIMS 1. A method of implanting a baroreflex activation device within a patient, comprising: accessing, by an implantation procedure, a target location proximate a facial vein of the patient, wherein the target location is proximate the carotid sinus of the patient; introducing, by a delivery device, an electrode structure of the baroreflex activation device to the target location, wherein the electrode structure is configured for electrical stimulation; verifying placement of the electrode structure at the target location by applying one or more electrical stimulations to the target location; and controlling the implanted baroreflex activation device to stimulate baroreceptor activation in the patient using the electrode structure. 2. A method of implanting a baroreflex activation device via a contralateral technique, as shown and described herein. 3. A method of implanting a baroreflex activation device via an ipsilateral technique, as shown and described herein. 4. Devices, systems and methods as shown and described herein.