Patent Application
20230201580
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.
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 States 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.
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. Pat. 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.
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 housings and associated therapy electrodes with reduced form factors as compared to early systems. One such system, described in U.S. Pat. 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. Pat. 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. The percutaneous implant methods and devices described therein represent an improvement over prior approaches, however, opportunities exist for further refinements to fixation of the electrode, in lead body design, electrode design, and delivery tools and techniques.
The present disclosure addresses these concerns.
Some embodiments of the present disclosure relate to minimally invasive implantation of one or more components of a baroreflex activation device or system. Improvements to the lead body, lead fixation, electrode fixation, delivery methods, or combinations are contemplated.
In an embodiment, the lead body may include a passive fixation structure molded onto or otherwise coupled with the lead body. The lead body may have polyurethane barbs molded directly onto the tubing, with the electrode cable. The barbs molded directly into the lead tubing may help prevent the lead from moving once the electrode and lead is placed.
In another embodiment, the lead body may include an active fixation arrangement movable between a delivery state and a deployed state. The lead body may include a plurality of barbs that are retracted in the delivery state, depicting a smooth lead with no interruptions. In the deployed state, the barbs may extend through angled cuts in the lead body. The lead body may be made of a rigid plastic or a bio-resorbable material on one side of the polymer barbed wire. The barbs may extend or bend outwards to create a rigid structure to resist movement of the lead body after implantation.
In another embodiment, the lead body may include multiple rows of active fixation elements arranged around a circumference of the lead body. For example, the lead may include three lumens disposed therein, each lumen containing barbed fixation elements configured to be movable between a delivery state and a deployed state. The barbs may be made of a low durometer polymer (e.g., below 100 A, below 80 A, or as desired) in order to more effectively puncture the wall of the lumen. In yet another embodiment, there may be any number of lumens included in the lead design. The barbs may extend during device assembly during the manufacturing stage, or the barbs may extend as a mechanism during the delivery of the baroreflex device, after implantation. The barbs may be exposed on the lead body as the polymer wires of the lumen design are pulled backwards by a surgeon after implantation.
In another embodiment, the electrode, backer, or electrode structure may be altered to assist in fixation. The electrode may have a coil backer molded into a backer. The coil backer may be made of nitinol, or may vary in material and structure. The coil backer may vary in height, and the number of coil revolutions. The coil backer may be combined with any combination of the barbed structures for lead body designs discussed above.
In another embodiment, the back side of the electrode may have nitinol or rigid polymer hooks. The height and number of hooks may vary, in order to optimize fixation and ease of delivery. The hooks may be arranged in synchronous rows of any number, on an electrode body. The hooks may be on more than one surface, or the hooks may vary in direction. The hooks may resist movement as the lead is removed after implantation, by gripping to tissue after the electrode has been placed.
In another embodiment, the electrode structure may have a wing or hood or domed structure to restrict backward movement of the lead. The wing or hood may be comprised of nitinol frames, or a molded polymer structure. The wing or hood may be combined with any combination of the barbed structures for lead body designs discussed above.
In another embodiment, the electrode body may have a modified tool or device to aid in delivery. The electrode body may have a needle head that is permanently, or removably attached to create a pathway to the targeted delivery site. The needle head may stay with the electrode at the therapy site, or there may be a method of detachment for the needle head to be removed with the lead after implantation. The needle head may protect the space above the targeted therapy site, while creating structure for fixation if it is not detached after delivery and implantation.
The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
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:
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 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.
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.
For information pertaining to the cardiovascular, circulatory and nervous systems, as well as baroreceptor and baroreflex therapy systems that may be used in whole or in part with embodiments of the present disclosure, reference is made to the following commonly assigned published applications and 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. No. 6,522,926 to Kieval et al., U.S. Pat. No. 6,850,801 to Kieval et al., U.S. Pat. No. 6,985,774 to Kieval et al., U.S. Pat. No. 7,480,532 to Kieval et al., U.S. Pat. No. 7,499,747 to Kieval et al., U.S. Pat. No. 7,835,797 to Rossing et al., U.S. Pat. No. 7,840,271 to Kieval et al., U.S. Pat. No. 8,086,314 to Kieval, U.S. Pat. No. 8,326,430 to Georgakopoulos et al., and U.S. Pat. No. 9,345,877 to Pignato et al., the disclosures of which are hereby incorporated by reference in their entireties except for the claims and any expressly contradictory definitions.
Embodiments of the present disclosure generally pertain to improved devices and methods for implanting a baroreflex activation therapy system. In an embodiment, the baroreflex activation therapy system can be as described in U.S. Pat. No. 8,437,867 to Murney et al., the disclosure of which is incorporated by reference herein. A description of percutaneous, minimally invasive methods and related devices, is included in published PCT application WO 2020/037145 (“the '145 PCT publication”) to Pignato et al., the disclosure of which is hereby incorporated by reference.
The '145 PCT publication generally describes a lead delivery tool which can be introduced over a guidewire, to deliver an electrode attached to a lead to a target implant location. The electrode and corresponding electrode structure may include passive fixation elements such as a mesh bundle or barbed suture, the passive fixation elements configured to retain the electrode and electrode structure in place at the target implant location. However, use of the lead delivery tool described in the '145 PCT publication dilates or “tunnels” soft tissue below the skin along the path of introduction, which includes the area proximate the target implant location where the electrode structure is implanted. In some instances, the space created by the dilation is large enough that the passive fixation elements included with the electrode structure can be less effective than desired in one or more directions, which can contribute to undesirable migration of the electrode structure, or reduced effectiveness of therapy delivered via the electrode, or both.
Embodiments of the present disclosure may provide more robust fixation of a lead body or electrode structure at a target implant location, less invasive implant procedures, combinations thereof, or other advantages. Where applicable, description of common components among embodiments of the present disclosure may not be repeated in the following, and like numerals may designate like parts throughout that are corresponding or analogous.
Referring now to
In embodiments, baroreflex activation device 70 may comprise an electrode structure 78 which generally includes an electrode 112 mounted on, integrated with, or otherwise coupled to a backer 114 (with electrode 112 arranged on an underside of electrode structure 78 of
In one embodiment, electrode 112 may have a diameter of about 1 mm, and backer 114 may have a diameter of about 6 mm. However, it is contemplated that electrode 112 may have a diameter within a range of about 0.25 mm-3 mm, while backer 114 may have a diameter within a range of about 1 mm-10 mm. In one embodiment the diameter of backer 114 is at least twice the diameter of electrode 112. In an embodiment, the surface area of the backer is at least twice the area of the electrode. In an embodiment, the surface area of the backer is about ten times the area of the electrode.
In embodiments, electrode 112 comprises a cathode, and in one embodiment housing 68 of control system 60 may comprise an anode. In another embodiment, reference electrode 67 may comprise an anode. In another embodiment, an anode may be provided as part of lead 72. In another embodiment, an anode is provided on a second lead which is also coupled to control system 60. In embodiments, the anode may be sufficiently larger than the cathode, for example ten times larger. In another embodiment the anode is fifty times larger than the cathode. Further, the anode and cathode are preferably positioned at a minimum distance away from one another, for example, the distance may be about twenty times the cathode diameter. In another embodiment, the distance between anode and cathode is at least fifty times the cathode diameter.
One or more electrode structures 78 may be provided as part of a baroreflex activation therapy system according to embodiments. For example, a first electrode structure 78 may be positioned at a first anatomical location, while a second electrode structure 78 is positioned at a second anatomical location, such as for example at a left carotid sinus and a right carotid sinus. Or a first electrode structure 78 may be positioned at a first anatomical location while a second electrode structure 78 is positioned at a second anatomical location proximate the first anatomical location, such as for example positioning first and second electrode structures proximate one another on the left carotid sinus and/or carotid arteries.
Lead 72 generally includes a proximal end having a connector for selectively coupling to header 69 of pulse generator housing 68, a body portion 75, and a distal end. In one embodiment, baroreceptor activation device 70 is disposed on the distal end of lead 72, although it will be understood that other arrangements of baroreceptor activation device 70 and lead 72 are within the spirit and scope of the present disclosure. In embodiments, leads described herein may be referred to as lead assemblies. Leads described herein are understood to include a conductor disposed within the lead body, the conductor extending between and electrically coupling the electrode to the connector on the proximal end of the lead.
In embodiments, the conductor may be connected to electrode structure 78 by mechanical or thermal means. In an embodiment, the conductor may be constructed as a multi-filament/stranded cable (e.g., 7×7) rather than the traditional wound coil configuration. In embodiments, cable construction of the conductor could have a diameter in the range of 0.005 inches to 0.250 inches.
The control system 60 generates a control signal (also referred to as a therapy signal), which activates, deactivates or otherwise modulates the baroreflex activation device 70. In an embodiment, the therapy signal is in the range of about 1 to 10 volts, at a rate between 5 Hz and 200 Hz, with an amplitude between 1 and 50 milliamps. Typically, activation of the device 70 via the control signal results in activation of baroreceptors of a patient. Alternatively, deactivation or modulation of the baroreflex activation device 70 may cause or modify activation of the baroreceptors. The baroreflex activation device 70 may include a wide variety of devices which utilize electrical means, such as electrodes, to activate baroreceptors.
The control system memory may contain data related to the therapy signal, a sensor signal, and/or values and commands provided by an input device, such as an external programmer operated by a patient or a clinician. The memory may also include software containing one or more algorithms defining one or more functions or relationships between the therapy signal and the sensor signal. The algorithm may dictate activation or deactivation therapy signals depending on the sensor signal or a mathematical derivative thereof. The algorithm may dictate an activation or deactivation therapy signal when the sensor signal falls below a lower predetermined threshold value, rises above an upper predetermined threshold value or when the sensor signal indicates a specific physiologic event. The memory may also include software containing one or more algorithms for determining patient physiological parameters based on a measured parameter.
In embodiments, aspects of the disclosure pertain to improvements to the lead, the lead body, the electrode structure, or combinations thereof.
Referring now to
Prior approaches to electrode structure designs, for not only baroreflex activation devices specifically but for implantable stimulation devices generally, favored highly flexible, compliant constructions. One common approach utilized silicone, with an optional reinforced nylon layer for resistance to tearing if the electrode structure was intended to be sutured at a target implant location. The use of a flexible, compliant electrode structure has been favored for, among other reasons, ability to readily conform to curved or irregular anatomical structures such as the outside (outer surface) of a blood vessel.
In contrast, the inventors of the present disclosure have found the ability for an electrode structure to conform to a curved anatomical structure less critical than previously thought. A generally rigid electrode structure, such as electrode structure 178 depicted in
In other embodiments, aspects of the present disclosure pertain to improvements for fixation of the lead. Fixation may be of the passive type, active type, or combinations thereof.
Referring now to
Referring now to
Referring now to
In other embodiments, aspects of the present disclosure pertain to improvements for fixation of the electrode structure in one or more directions or axes. Fixation may be of the passive type, active type, or combinations thereof. The lead body fixation mechanisms restrict movement of the lead in the axial direction, whereas the electrode fixation mechanisms fix the actual electrode in place (typically in all directions, x, y and z as depicted in
Referring now to
In use, electrode structure 578 may be arranged in a delivery position wherein coil 586 is substantially collapsed with respect to backer 514. An introducer or delivery tool may be utilized to selectively retain electrode structure 578 in the delivery position. A surgeon or medical practitioner may tunnel or otherwise dilate tissue within a patient along a desired path of introduction to a target implant location. Electrode structure 578 may be delivered concurrently with a tunneling procedure, or subsequently. Upon delivery of electrode structure 578 to the target implant location, coil 586 may be released into the deployed position depicted in
Referring now to
In embodiments wherein hooks 698 are collapsible, in use, electrode structure 678 may be arranged in a delivery position wherein hooks 698 are substantially collapsed with respect to backer 614. An introducer or delivery tool may be utilized to selectively retain electrode structure 678 in the delivery position. A surgeon or medical practitioner may tunnel or otherwise dilate tissue within a patient along a desired path of introduction to a target implant location. Electrode structure 678 may be delivered concurrently with a tunneling procedure, or subsequently. Upon delivery of electrode structure 678 to the target implant location, hooks 698 may be released into the deployed position depicted in
Referring now to
In use, electrode structure 778 may be implanted using an introducer or delivery tool. A surgeon or medical practitioner may tunnel or otherwise dilate tissue within a patient along a desired path of introduction to a target implant location. Electrode structure 778 may be delivered concurrently with a tunneling procedure, or subsequently. Upon delivery of electrode structure 778, dome 796 is configured to substantially fill any tissue space created by the tunneling and thus helps to retain backer 714 against the target location. Additionally, leading profile 797 constrains movement of electrode structure 778 from any further movement or migration in the direction of tunneling, while hook portion 798 constrains movement of electrode structure 778 from retraction or backward movement or migration in the direction of tunneling. Thus electrode structure 778 with dome 796 is constrained in a lateral anatomical direction, as well as in the superior/inferior and anterior/posterior anatomical directions.
In other embodiments, aspects of the present disclosure pertain to improvements for delivery tools used during the implant procedure of baroreflex activation devices.
Referring now to
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 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, 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 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 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.
The present application claims the benefit of U.S. Provisional Patent Application No. 63/294,649, filed Dec. 29, 2022, the disclosure of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63294649 | Dec 2021 | US |
