Patent Description:
The sympathetic nervous system (SNS) is a primarily involuntary bodily control system typically associated with stress responses. Fibers of the SNS extend through tissue in almost every organ system of the human body and can affect characteristics such as pupil diameter, gut motility, and urinary output. Such regulation can have adaptive utility in maintaining homeostasis or in preparing the body for rapid response to environmental factors. Chronic activation of the SNS, however, is a common maladaptive response that can drive the progression of many disease states. Excessive activation of the renal SNS, in particular, has been identified experimentally and in humans as a likely contributor to the complex pathophysiologies of hypertension, states of volume overload (c. , heart failure), and progressive renal disease.

Sympathetic nerves of the kidneys terminate in the renal blood vessels, the juxtaglomerular apparatus, and the renal tubules, among other structures. Stimulation of the renal sympathetic nerves can cause, for example, increased renin release, increased sodium reabsorption, and reduced renal blood flow. These and other neural-regulated components of renal function are considerably stimulated in disease states characterized by heightened sympathetic tone. For example, reduced renal blood flow and glomerular filtration rate as a result of renal sympathetic efferent stimulation is likely a cornerstone of the loss of renal function in cardio-renal syndrome (i. , renal dysfunction as a progressive complication of chronic heart failure). Pharmacologic strategies to thwart the consequences of renal sympathetic stimulation include centrally-acting sympatholytic drugs, beta blockers (e.g., to reduce renin release), angiotensin-converting enzyme inhibitors and receptor blockers (e.g., to block the action of angiotensin II and aldosterone activation consequent to renin release), and diuretics (e.g., to counter renal sympathetic mediated sodium and water retention). These pharmacologic strategies, however, have significant limitations including limited efficacy, compliance issues, side effects, and others. Document <CIT> relates to an ablation catheter.

Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings arc not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. For ease of reference, throughout this disclosure identical reference numbers may be used to identify identical or at least generally similar or analogous components or features.

Further embodiments are defined in dependent claims <NUM>-<NUM>. Specific details of systems, devices, and methods in accordance with several embodiments of the present technology are disclosed herein with reference to <FIG>. Although the systems, devices, and methods may be disclosed herein primarily or entirely with respect to intravascular renal neuromodulation, other applications in addition to those disclosed herein are within the scope of the present technology. For example, systems, devices, and methods in accordance with at least some embodiments of the present technology may be useful for neuromodulation within a body lumen other than a vessel, for extravascular neuromodulation, for non-renal neuromodulation, and/or for use in therapies other than neuromodulation. The methods and systems disclosed herein are not claimed, but are useful for the general understanding of the Invention.

As used herein, the terms "distal" and "proximal" define a position or direction with respect to a clinician or a clinician's control device (e.g., a handle of a catheter). The terms, "distal" and "distally" refer to a position distant from or in a direction away from a clinician or a clinician's control device. The terms "proximal" and "proximally" refer to a position near or in a direction toward a clinician or a clinician's control device. The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.

<FIG> is a partially schematic perspective view illustrating a therapeutic system <NUM> configured in accordance with an embodiment of the present technology. The system <NUM> can include a neuromodulation catheter <NUM>. a console <NUM>. and a cable <NUM> extending between the catheter <NUM> and the console <NUM>. The catheter <NUM> can include an elongate shaft <NUM> having a proximal end portion 108a. a distal end portion 108b. and an intermediate portion 108c therebetween. The catheter <NUM> can further include a handle <NUM> operably connected to the shaft <NUM> via the proximal end portion 108a of the shaft <NUM> and a neuromodulation element <NUM> (shown schematically in <FIG>) operably connected to the shaft <NUM> via the distal end portion 108b of the shaft <NUM>. The shaft <NUM> can be configured to locate the neuromodulation element <NUM> at a treatment location within or otherwise proximate to a body lumen (e.g., a blood vessel, a duct, an airway, or another naturally occurring lumen within the human body). In some embodiments, the shaft <NUM> can be configured to locate the neuromodulation clement <NUM> at an intraluminal (e.g., intravascular) location. The neuromodulation element <NUM> can be configured to provide or support a neuromodulation treatment at the treatment location. The shaft <NUM> and the neuromodulation element <NUM> can be <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> French or other suitable sizes.

Intraluminal delivery of the catheter <NUM> can include percutaneously inserting a guide wire (not shown) into a body lumen of a patient and moving the shaft <NUM> and the neuromodulation element <NUM> along the guide wire until the neuromodulation element <NUM> reaches a suitable treatment location. Alternatively, the catheter <NUM> can be a steerable or non-steerable device configured for use without a guide wire. As another alternative, the neuromodulation catheter <NUM> can be configured for use with a guide catheter or sheath (not shown). In the illustrated embodiment, the console <NUM> is configured to control, monitor, supply, and/or otherwise support operation of the catheter <NUM>. In other embodiments, the catheter <NUM> can be self-contained or otherwise configured for operation independent of the console <NUM>. When present, the console <NUM> can be configured to generate a selected form and/or magnitude of energy for delivery to tissue at a treatment location via the neuromodulation element <NUM>. For example, the console <NUM> can be configured to generate radio frequency (RF) energy (e.g., monopolar and/or bipolar RF energy) and/or another suitable type of energy for delivery to tissue at a treatment location via electrodes (not shown) of the neuromodulation element <NUM>. Along the cable <NUM> or at another suitable location within the system <NUM>, the system <NUM> can include a control device <NUM> configured to initiate, terminate, and/or adjust operation of one or more components of the catheter <NUM> directly and/or via the console <NUM>. The console <NUM> can be configured to execute an automated control algorithm <NUM> and/or to receive control instructions from an operator. Similarly, the console <NUM> can be configured to provide feedback to an operator before, during, and/or after a treatment procedure via an evaluation/feedback algorithm <NUM>.

<FIG> is an exploded profile view of the catheter <NUM>. <FIG> and <FIG> are enlarged exploded profile views of portions of the catheter <NUM> taken at respective locations designated in <FIG>. With reference to <FIG> and <FIG> together, the handle <NUM> can include mating shell segments <NUM> (individually identified as shell segments <NUM>a, 120b) and a connector <NUM> (e.g., a lucr connector) operably positioned between the mating shell segments <NUM>. The handle <NUM> can further include a distally tapered strain-relief element <NUM> operably connected to distal ends of the shell segments <NUM>. Slidably positioned over the shaft <NUM>, the catheter <NUM> can include a loading tool <NUM> configured to facilitate loading the catheter <NUM> onto a guide wire (not shown). When assembled, the shaft <NUM> can extend through coaxial lumens (also not shown) of the strain-relief element <NUM> and the loading tool <NUM>, respectively, and between the shell segments <NUM> to the connector <NUM>.

The shaft <NUM> can include an assembly of parallel tubular segments. At its proximal end portion 108a and extending distally though a majority of its intermediate portion 108c, the shaft <NUM> can include a proximal hypotube segment <NUM>, a proximal jacket <NUM>, a first electrically insulative tube <NUM>, and a guide-wire tube <NUM>. The first electrically insulative tube <NUM> and the guide-wire tube <NUM> can be disposed side-by-side within the proximal hypotube segment <NUM>. The first electrically insulative tube <NUM> can be configured to carry electrical leads (not shown) and to electrically insulate the electrical leads from the proximal hypotube segment <NUM>. The guide-wire tube <NUM> can be configured to carry a guide wire (not shown). The proximal jacket <NUM> can be disposed around at least a portion of an outer surface of the proximal hypotube segment <NUM>. The proximal hypotube segment <NUM> can include a proximal stem <NUM> at its proximal end and a distal skive <NUM>. at its distal end. The proximal jacket <NUM> and the proximal hypotube segment <NUM> are discussed in greater detail below with reference to <FIG>.

With reference again to <FIG> and <FIG>, the first electrically insulative tube <NUM> and the guide-wire tube <NUM> can extend distally beyond the distal skive <NUM>. The shaft <NUM> can include an intermediate tube <NUM> beginning proximally at a region of the shaft <NUM> at which the first electrically insulative tube <NUM> and the guide-wire tube <NUM> distally emerge from the proximal hypotube segment <NUM>. The intermediate tube <NUM> can be more flexible than the proximal hypotube segment <NUM>. At the region of the shaft <NUM> at which the first electric ally insulative tube <NUM> and the guide-wire tube <NUM> distally emerge from the proximal hypotube segment <NUM>, the intermediate tube <NUM> can be coaxially aligned with the proximal hypotube segment <NUM> so as to receive the first electrically insulative tube <NUM> and the guide-wire tube <NUM>. From this region, the intermediate tube <NUM> can extend distally to the distal end portion 108b of the shaft <NUM>. The first electrically insulative tube <NUM> can distally terminate within the intermediate tube <NUM>. In contrast, the guide-wire tube <NUM> can extend through the entire length of the intermediate tube <NUM>, At a distal end of the intermediate tube <NUM>, the shaft <NUM> can be operably connected to the neuromodulation clement <NUM>.

<FIG> is a further enlarged cross-sectional view of the intermediate tube <NUM> taken along a line <NUM>-<NUM> designated in <FIG>. Arranged from innermost to outermost, the intermediate tube <NUM> can include an inner polymer layer 140a, a metal braid 140b, a first outer polymer layer 140c, and a second outer polymer layer !40d. In a particular embodiment, the inner polymer layer 140a is made of polyimide (e.g., about <NUM> inch thick); the metal braid 140b is made of stainless steel; the first outer polymer layer 140c is made of coated polyimide (e.g., three coats); and the second outer polymer layer 140d is made of polyether block amide (e.g., PEBAX") (e.g., about <NUM> inch thick). Other suitable compositions and arrangements are also possible. In some embodiments, at least a portion of the intermediate tube <NUM> is film-cast. For example, disposing the first outer polymer layer 140c onto the metal braid 140b as a series of thin films can allow the thickness of the first outer polymer layer 140c to be precisely controlled. Accordingly, the first outer polymer layer 140c can be just thick enough to prevent the ends of the metal braid 140b from becoming exposed or otherwise damaged when thermally bonding the intermediate tube <NUM> to the proximal and distal hypotube segments <NUM>, <NUM>, respectively, but not so thick as to cause the intermediate tube <NUM> to become excessively stiff. This can reduce or eliminate the need to locally reinforce the ends of the intermediate tube <NUM> or to splice coupling components onto the ends of the intermediate tube <NUM> to facilitate bonding the intermediate tube <NUM> to the proximal and distal hypotube segments <NUM>, <NUM>.

The neuromodulation element <NUM> can include a distal hypotube segment <NUM> coupled to the distal end of the intermediate tube <NUM>. The neuromodulation element <NUM> can also include a distal jacket <NUM> disposed around at least a portion of an outer surface of the distal hypotube segment <NUM>. As shown, the neuromodulation element <NUM> can further include band electrodes <NUM> disposed outside the distal jacket <NUM> at spaced-apart positions along a longitudinal axis of the distal jacket <NUM>. At a distal end of the distal hypotube segment <NUM>, the neuromodulation element <NUM> can include a distally tapering atraumatic tip <NUM>. The guide-wire tube <NUM> can extend through the distal hypotube segment <NUM> to a distal opening <NUM> of the tip <NUM>. The electrical leads can respectively extend through the distal hypotube segment <NUM> to the band electrodes <NUM>.

In <FIG> and <FIG>, the neuromodulation element <NUM> is shown in a radially expanded deployed state. The neuromodulation element <NUM> can be movable from a low-profile delivery state to the radially expanded deployed state. When the neuromodulation element <NUM> is in the radially expanded deployed state, the distal hypotube segment <NUM> can have a shape that is more helical (spiral) than its shape when the neuromodulation element <NUM> is in the low-profile delivery state. In at least some cases, the distal hypotube segment <NUM> has the more helical shape when at rest and is configured to be forced into the less helical shape by an external sheath (not shown). The distal hypotube segment <NUM> can be made at least partially of nitinol, stainless steel, or another suitable material well suited for resiliently moving between the more helical and less helical shapes. In at least some cases, the material of the distal hypotube segment <NUM> is electrically conductive. Accordingly, the ncuromodulation element <NUM> can include a second electrically insulative tube <NUM> disposed around an outer surface of the distal hypotube segment <NUM> so as to electrically separate the band electrodes <NUM> from the distal hypotube segment <NUM>. In some embodiments, the firs! and second electrically insulative tubes <NUM>, <NUM> are made at least partially (e.g., predominantly or entirely) of polyimide and polyether block amide, respectively. In other embodiments, the first and second electrically insulative tubes <NUM>, <NUM> can be made of other suitable materials.

<FIG> is a profile view of the proximal hypotube segment <NUM> and the proximal jacket <NUM>. <FIG> is a cross-sectional profile view of the proximal hypotube segment <NUM> and the proximal jacket <NUM> taken along a line <NUM>-<NUM> designated in <FIG> is an enlarged profile view of a portion of the proximal hypotube segment <NUM> and the proximal jacket <NUM> taken at a location designated in <FIG>. As shown in <FIG>, the proximal jacket <NUM> can be absent from the outer surface of the proximal hypotube segment <NUM> at the proximal stem <NUM>. This can be useful, for example, to facilitate connecting the proximal hypotube segment <NUM> to the connector <NUM>. In contrast, the proximal jacket <NUM> can be disposed on at least a portion of the outer surface of the proximal hypotube segment <NUM> at the distal skive <NUM>. in some embodiments, the proximal hypotube segment <NUM> is made at least partially (e.g., predominantly or entirely) of nitinol, In these and other embodiments, the proximal jacket <NUM> can be made at least partially (e.g., predominantly or entirely) of a polymer blend including polyether block amide and polysiloxane. For example, the polymer blend can include greater than <NUM>% polysiloxane. In a particular embodiment, the polymer blend includes about <NUM>% by weight polyether block amide and about <NUM>% by weight polyether block amide. This material may allow the proximal jacket <NUM> to have sufficient lubricity for use without an outer coating, among other potential advantages. In still other embodiments, the proximal hypotube segment <NUM> and the proximal jacket <NUM> can be made of other suitable materials.

<FIG> is a perspective view of a distal jacket <NUM> of a neuromodulation element of a neuromodulation catheter configured in accordance with an embodiment of the present technology. The distal jacket <NUM>, for example, can be used in the neuromodulation clement <NUM><NUM> (<FIG>, <FIG> and <FIG>) in place of the distal jacket <NUM> (<FIG> and <FIG>). Accordingly, the distal jacket <NUM> may be described below in conjunction with components of the catheter <NUM> (<FIG> and <FIG>). The distal jacket <NUM> can include reduced-diameter segments <NUM> (individually identified as reduced-diameter segments 202a-202d) extending through its outer surface. <FIG> is a profile view of the distal jacket <NUM> and band electrodes <NUM> (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments <NUM>. <FIG> is a profile view of the distal jacket <NUM> without the band electrodes <NUM>. <FIG> is an enlarged profile view of a portion of the distal jacket <NUM> taken at a location designated in <FIG>. <FIG> is a cross-sectional profile view of the distal jacket <NUM> taken along a line <NUM>-<NUM> designated in <FIG>.

With reference to <FIG> together, the distal jacket <NUM> can be tubular and configured to be disposed around at least a portion of an outer surface (if the distal hypotube segment <NUM> (<FIG> and <FIG>). The reduced-diameter segments <NUM> can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes <NUM>. In the illustrated embodiment, the distal jacket <NUM> includes exactly four reduced-diameter segments <NUM> spaced apart along its longitudinal axis. Alternatively, the distal jacket <NUM> can include exactly one, two, three, five, six or a greater number of reduced-diameter segments <NUM>. The reduced-diameter segments <NUM> may be spaced apart at equal distances or at different distances. The distal jacket <NUM> can include openings <NUM> respectively positioned at the reduced-diameter segments <NUM>. A neuromodulation catheter including the distal jacket <NUM> can include electrical leads (not shown) extending from respective reduced-diameter segments <NUM>, through respective openings <NUM>, through a lumen of the distal hypotube segment <NUM> (<FIG> and <FIG>), through the intermediate tube <NUM>, and through the proximal hypotube segment <NUM> to the handle <NUM>. In this way, the electrical leads can respectfully connect the band electrodes <NUM> to proximal components of a neuromodulation catheter including the distal jacket <NUM>.

<FIG> are enlarged cross-sectional profile views of a portion of the distal jacket <NUM> at a location designated in <FIG>. At this location, the distal jacket <NUM> can include the reduced-diameter segment 202a. In <FIG>, the portion of the distal jacket <NUM> is shown without the band electrode 204a corresponding to the reduced-diameter segment 202a. In <FIG>, the portion of the distal jacket <NUM> is shown resiliently deformed inwardly as the band electrode <NUM>,j is moved toward the reduced-diameter segment 202a. In <FIG>, the portion of the distal jacket <NUM> is shown with the band electrode 204a seated in the reduced-diameter segment 202a. With reference to <FIG> together, the band electrodes <NUM> can respectively form closed loops extending circumferentially around the distal jacket <NUM>. in at least some cases, a minimum inner diameter of the band electrodes <NUM> is smaller than a maximum outer diameter of distal jacket <NUM> between the reduced-diameter segments <NUM>. To facilitate assembly, the distal jacket <NUM> between the reduced-diameter segments <NUM> can be resilient in response to 0peristaltic deflection of a magnitude corresponding to a difference between the maximum outer diameter of the distal jacket <NUM> between the reduced-diameter segments <NUM> and the minimum inner diameter of the band electrodes <NUM>. Suitable materials for the distal jacket <NUM> include polymer blends including polyurethane and polysiloxane, among others,.

A maximum outer diameter of the band electrodes <NUM> and the maximum outer diameter of the distal jacket <NUM> between the reduced-diameter segments <NUM> can be at least generally equal (e.g., within <NUM>%, <NUM>%, or <NUM>% of one another). Thus, once the band electrodes <NUM> are respectively seated in the reduced-diameter segments <NUM>, outer surfaces of the band electrodes <NUM> and the distal jacket <NUM> between the reduced-diameter segments <NUM> can be at least generally flush. This can be useful, for example, to reduce or eliminate potentially problematic ridges (e.g., circumferential steps) at distal and proximal ends of the individual band electrodes <NUM>. This, in turn, can reduce or eliminate the need for fillets (c. , adhesive fillets, such as glue fillets) at the distal and proximal ends of the individual band electrodes <NUM>. In at least some embodiments, the distal jacket <NUM> and the band electrodes <NUM> can be bonded to one another without any exposed adhesive. For example, an adhesive (not shown) can be disposed between the band electrodes <NUM> and the distal jacket <NUM> at the reduced-diameter segments <NUM>.

<FIG> is an enlarged cross-sectional profile view of a sidewall of the reduced-diameter segment 202a at a location designated in <FIG>. As shown in <FIG>, the reduced-diameter segment 202a. can include a floor <NUM>, a sidewall <NUM>, and a corner <NUM> therebetween. The distal jacket <NUM> can further include a rim <NUM> bordering the reduced-diameter segment 202a. In the illustrated embodiment, the sidewall <NUM> is vertical and perpendicular to the floor <NUM> and the rim <NUM>. in particular, the sidewall <NUM> meets the floor <NUM> and the rim <NUM> at a <NUM>° angle and a <NUM>° angle, respectively. This configuration of the sidewall <NUM> can facilitate secure seating of a band electrode (not shown in <FIG>) in the reduced-diameter segment 202a without a gap being formed between the band electrode and an upper portion of the sidewall <NUM>. Such a gap can be problematic, for example, because it can present an edge that may interfere with smooth movement of the distal jacket <NUM> through a patient's vasculature. Disadvantageously, tensile loading on the distal jacket <NUM> may tend to concentrate at the corner <NUM>. This can adversely affect the durability of the distal jacket <NUM>.

Sidewall configurations different than the configuration shown in <FIG> may be advantageous in at least some cases. <FIG> illustrate two examples of such alternative configurations. <FIG>, in particular, is an enlarged cross-sectional profile view of a portion of a distal jacket <NUM> including a reduced-diameter segment <NUM> having a floor <NUM>, a sidewall <NUM>, and a rounded junction <NUM> therebetween. The distal jacket <NUM> can further include a rim <NUM> bordering the reduced-diameter segment <NUM>. In the illustrated embodiment, the sidewall <NUM> is slanted relative to the floor <NUM> and the rim <NUM>. The reduced-diameter segment <NUM> can have a depth (D) between the floor <NUM> and the rim <NUM>. The rounded junction <NUM> can have a radius (R) within a range from <NUM>% to <NUM>% of the depth. In at least some embodiments, the radius is within a range from <NUM> mil to <NUM> mils (e.g., a range from <NUM> mil to <NUM> mils). The shape of the rounded junction <NUM> can promote diffusion of tensile loading on the distal jacket <NUM>, thereby enhancing the durability of the distal jacket <NUM>. Furthermore, the sidewall <NUM> and the rounded junction <NUM> can be entirely on one side of a plane along which a portion of the floor <NUM> directly adjacent to the rounded junction <NUM> lies. Because the sidewall <NUM> and the rounded junction <NUM> do not extend through this plane, the material thickness of the distal jacket <NUM> at the rounded junction <NUM> can be no less than the material thickness of the distal jacket <NUM> elsewhere along the reduced-diameter segment <NUM>. Correspondingly, the tensile strength of the distal jacket <NUM> at the rounded junction <NUM> can be no less than the material thickness of the distal jacket <NUM> elsewhere along the reduced-diameter segment <NUM>.

<FIG> is an enlarged cross-sectional profile view of a portion of a distal jacket <NUM> including a reduced-diameter segment <NUM> having a floor <NUM>, a sidewall <NUM>, and a rounded junction <NUM> therebetween. The distal jacket <NUM> can further include a rim <NUM> bordering the reduced-diameter segment <NUM>. In the illustrated embodiment, the sidewall <NUM> is more vertical relative to the floor <NUM> and the rim <NUM> than the sidewall <NUM> of the reduced-diameter segment <NUM> shown in <FIG>. In at least some embodiments, the sidewall <NUM> from the rounded junction <NUM> to the rim <NUM> has an average angle (A) greater than <NUM>'' (e.g., greater than <NUM>°) relative to the rim <NUM>. As discussed above with reference to <FIG>, vertical or near-vertical orientation of the sidewall <NUM> can facilitate secure seating of a band electrode (not shown in <FIG>) in the reduced-diameter segment <NUM> without a gap or with only a minor gap being formed between the band electrode and an upper portion of the sidewall <NUM>.

<FIG> is a flow chart illustrating a method <NUM> for making a neuromodulation element including the distal jacket <NUM> and the band electrodes <NUM> in accordance with an embodiment, of the present technology. With reference to <FIG> together, the method <NUM> can begin with forming the distal jacket <NUM>. This can include forming a tubular blank (block <NUM>) (e.g., by extrusion) and then using a subtractive process (e.g., by laser ablation) to remove portions of the blank and thereby form the reduced-diameter segments <NUM> (block <NUM>). The same or a different subtractive process can be used to form the openings <NUM> (block <NUM>). Alternatively, the distal jacket <NUM> can be formed by injection molding or another suitable technique that allows the reduced-diameter segments <NUM> and/or the openings <NUM> to be formed without the need for a subtractive process. When a subtractive process is used to form the reduced-diameter segments <NUM>, the subtractive process can be precisely controlled so as to leave an innermost portion of a wall of the distal jacket <NUM> intact at the reduced-diameter segments <NUM>. Laser ablation is one example of a suitable subtractive process for forming the reduced-diameter segments <NUM>. Laser ablation can include loading the blank onto a mandrel and then rotating the blank and the mandrel relative to an ablative laser (or rotating the ablative laser relative to the black and the mandrel) under computerized control. The mandrel can conductivelv cool the innermost portion of the wall of the distal jacket <NUM> so as to prevent this portion of the wall from reaching ablative temperatures at the reduced-diameter segments <NUM>. Furthermore, laser ablation and other subtractive processes can be carefully controlled to avoid forming a notch or other indentation in the distal jacket <NUM> below the floor <NUM> at the comer <NUM>. When present, such an indentation may unduly decrease the tensile strength of the distal jacket <NUM>. Other techniques for forming the reduced-diameter segments <NUM> are also possible,.

The method <NUM> can further include jacketing the distal hypotube segment <NUM> (block <NUM>), such as by positioning the distal jacket <NUM> and the distal hypotube segment <NUM> relative to one another so that the distal jacket <NUM> is disposed around at least a portion of an outer surface of the distal hypotube segment <NUM>. In at least some embodiments, the form and/or other aspects of the distal jacket <NUM> may allow the distal jacket <NUM> to be disposed around at least a portion of the outer surface of the distal hypotube segment <NUM> without swaging the distal jacket <NUM>. When the distal hypotube segment <NUM> is positioned within the distal jacket <NUM>, the method <NUM> can include respectively stringing electrical leads (block <NUM>) from the reduced-diameter segments <NUM> through a lumen of the distal hypotube segment <NUM>. Next, the method <NUM> can include dispensing an adhesive (block <NUM>) onto the distal jacket <NUM> at the reduced-diameter segment 202d. Then, the method <NUM> can include positioning the band electrode 204d (block <NUM>) at the reduced-diameter segment 202d. As discussed above with reference to <FIG>, positioning the band electrode 204d can include resiliently deforming the distal jacket <NUM> inwardly while passing (e.g., advancing or threading) the distal jacket <NUM> through a channel of the band electrode 204d so as to move the band electrode 204d toward a longitudinal position at which the band electrode 204d is aligned with the reduced-diameter segment 202d. The same process can be used to install the band electrodes 204c, the band electrode 204b, and finally the band electrode 204a.

Catheters configured in accordance with at least some embodiments of the present technology can be well suited (e.g., with respect to sizing, flexibility, operational characteristics, and/or other attributes) for performing renal neuromodulation in human patients. Renal neuromodulation is the partial or complete incapacitation or other effective disruption of nerves of the kidneys (e.g., nerves terminating in the kidneys or in structures closely associated with the kidneys). In particular, renal neuromodulation can include inhibiting, reducing, and/or blocking neural communication along neural fibers (e.g., efferent and/or afferent neural fibers) of the kidneys. Such incapacitation can be long-term (e.g., permanent or for periods of months, years, of decades) or short-term (e.g., for periods of minutes, hours, days, or weeks). Renal neuromodulation is expected to contribute to the systemic reduction of sympathetic tone or drive and/or to benefit at least some specific organs and/or other bodily structures innervated by sympathetic nerves. Accordingly, renal neuromodulation is expected to be useful in treating clinical conditions associated with systemic sympathetic overactivity or hyperactivity, particularly conditions associated with central sympathetic overstimulation. For example, renal neuromodulation is expected to efficaciously treat hypertension, heart failure, acute myocardial infarction, metabolic syndrome, insulin resistance, diabetes, left ventricular hypertrophy, chronic and end stage renal disease, inappropriate fluid retention in heart failure, cardio-renal syndrome, polycystic kidney disease, polycystic ovary syndrome, osteoporosis, erectile dysfunction, and sudden death, among other conditions.

Renal neuromodulation can be electrically-induced, thermally-induced, or induced in another suitable manner or combination of manners at one or more suitable treatment locations during a treatment procedure. The treatment location can be within or otherwise proximate to a renal lumen (e.g., a renal artery, a ureter, a renal pelvis, a major renal calyx, a minor renal calyx, or another suitable structure), and the treated tissue can include tissue at least proximate to a wall of the renal lumen. For example, with regard to a renal artery, a treatment procedure can include modulating nerves in the renal plexus, which lay intimately within or adjacent to the adventitia of the renal artery. Various suitable modifications can be made to the catheters described above to accommodate different treatment modalities. For example, the band electrodes <NUM> (<FIG>) can be replaced with transducers to facilitate transducer-based treatment modalities.

Renal neuromodulation can include an electrode-based or treatment modality alone or in combination with another treatment modality. Electrode-based or transducer-based treatment can include delivering electricity and/or another form of energy to tissue at or near a treatment location to stimulate and/or heat the tissue in a manner that modulates neural function. For example, sufficiently stimulating and/or heating at least a portion of a sympathetic renal nerve can slow or potentially block conduction of neural signals to produce a prolonged or permanent reduction in renal sympathetic activity. A variety of suitable types of energy can be used to stimulate and/or heat tissue at or near a treatment location. For example, neuromodulation in accordance with embodiments of the present technology can include delivering RF energy, pulsed electrical energy, microwave energy, optical energy, focused ultrasound energy (e.g., high-intensity focused ultrasound energy), and/or another suitable type of energy. An electrode or transducer used to deliver this energy can be used alone or with other electrodes or transducers in a multi-electrode or multi-transducer array.

Neuromodulation using focused ultrasound energy (e.g., high-intensity focused ultrasound energy) can be beneficial relative to neuromodulation using other treatment modalities. Focused ultrasound is an example of a transducer-based treatment modality that can be delivered from outside the body. Focused ultrasound treatment can be performed in close association with imaging (e.g., magnetic resonance, computed tomography, fluoroscopy, ultrasound (e.g., intravascular or intraluminal), optical coherence tomography, or another suitable imaging modality). For example, imaging can be used to identify an anatomical position of a treatment location (e.g., as a set of coordinates relative to a reference point). The coordinates can then entered into a focused ultrasound device configured to change the power, angle, phase, or other suitable parameters to generate an ultrasound focal zone at the location corresponding to the coordinates. The focal zone can be small enough to localize therapeutically-effective heating at the treatment location while partially or fully avoiding potentially harmful disruption of nearby structures. To generate the focal zone, the ultrasound device can be configured to pass ultrasound energy through a lens, and/or the ultrasound energy can be generated by a curved transducer or by multiple transducers in a phased array, which can be curved or straight.

Heating effects of electrode-based of transducer-based treatment can include ablation and/or non-ablative alteration or damage (e.g., via sustained heating and/or resistive heating). For example, a treatment procedure can include raising the temperature of target neural fibers to a target temperature above a first threshold to achieve non-ablative alteration, or above a second, higher threshold to achieve ablation. The target temperature can be higher than about body temperature (e.g., about <NUM>) but less than about <NUM> for non-ablative alteration, and the target temperature can be higher than about <NUM> for ablation. Heating tissue to a temperature between about body temperature and about <NUM> can induce non-ablative alteration, for example, via moderate heating of target neural fibers or of luminal structures that perfuse the target neural fibers. In cases where luminal structures are affected, the target neural fibers can be denied perfusion resulting in necrosis of the neural tissue. Heating tissue to a target temperature higher than about <NUM> (e.g., higher than about <NUM>) can induce ablation, for example, via substantial heating of target neural fibers or of luminal structures that perfuse the target fibers. In some patients, it can be desirable to heat tissue to temperatures that are sufficient to ablate the target neural fibers or the luminal structures, but that are less than about <NUM> (e.g., less than about <NUM>, less than about <NUM>, or less than about <NUM>).

Claim 1:
A neuromodulation catheter comprising:
a handle (<NUM>);
an elongated shaft (<NUM>) comprising:
a proximal hypotube segment (<NUM>) comprising a proximal stem (<NUM>) and a distal skive (<NUM>) at its distal end;
a proximal jacket (<NUM>) disposed around at least a portion of an outer surface of the proximal hypotube segment;
an intermediate tube (<NUM>) coaxially aligned with the proximal hypotube segment (<NUM>), wherein the intermediate tube is bonded to the proximal hypotube segment; and
a guidewire tube (<NUM>) disposed within the proximal hypotube segment and extending through an entire length of the intermediate tube (<NUM>); and
a neuromodulation element (<NUM>) connected to the shaft at a distal end of the intermediate tube (<NUM>).