Stimulation therapy device delivery system

Abstract

A medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors disposed within the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes.

Description

Docket No. A0012964W001STIMULATION THERAPY DEVICE DELIVERY SYSTEMCROSS-RELATED REFERENCES

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 777,976 filed March 26, 2025, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] This disclosure relates to electrical stimulation therapyBACKGROUND

[0003] Medical devices, such as electrical stimulation devices, may be used in different therapeutic applications, such as vagus nerve stimulation (VNS) and / or deep brain stimulation (DBS). A medical device may be used to deliver therapy to a patient to treat a variety of symptoms or patient conditions. In some therapy systems, an external or an implantable electrical stimulator delivers electrical stimulation therapy to a target tissue site within a patient with the aid of one or more electrode assemblies and / or senses one or more patient parameters with the aid of the one or more electrode assemblies.SUMMARY

[0004] This disclosure describes example medical devices and systems configured to endovascularly deliver electrical stimulation therapy to a patient (e.g., to one or more nerves or brain targets) and / or sense one or more patient parameters (e.g., nerve signals, brain signals, and / or other physiological parameters), and related methods. In particular, this disclosure describes systems configured for sensing (e.g., mapping) locations of one or more features (e.g., nerves) within the body of the patient, for determining a target implantation site for an example medical device, and / or for implantation of the example medical device within the body of the patient. An example system described herein may be used for the delivery and / or implantation of an endovascular medical device within the vasculature of the patient, though the example system may be used to deliver other example medical devices within other body lumen of the patient.

[0005] In the examples described herein, the example medical device includes one or more electrode assemblies that are carried by an expandable structure at a distal portion of an elongated body (e.g., a medical lead). The expandable structure is configured to transform between a delivery (e.g., compressed or relatively low-profile) configuration and a deployed (e.g., expanded) configuration. The expandable structure (e.g., a stent, or stent-like structure) includes struts and a plurality of electrode attachment elements. The expandable structure mayDocket No. A0012964W001 be expanded within a body lumen, e.g., to place electrodes in contact with tissue defining an inner surface of the body lumen and / or to secure the expandable structure within the body lumen. The expandable structure may be collapsed and / or retained in the delivery configuration within the body lumen, e.g., to facilitate navigation of the elongated body within the body lumen and / or to allow for re-positioning of the expandable structure within the body lumen.

[0006] In some examples, this disclosure describes a system for an implantable medical device (IMD). The example trialing and / or mapping system may include a multi-lumen structure and may be configured to deploy and / or collapse the expandable structure of the medical device. The example system may allow for improved navigability of the system and / or portions of the medical device within a body lumen and faster and / or simpler re-deployment of the medical device within the body of the patient, which may reduce a duration and / or complexity of a medical procedure and / or reduce a risk of failure by the system and / or by the medical device.

[0007] In some examples, this disclosure describes an implantation system for implantation of the IMD within the patient. The example implantation system may include a multi-lumen structure and may be configured to deploy and / or release the expandable structure of the IMD within the body lumen. The example implantation system may allow for improved navigability of the system and / or portions of the IMD within the body lumen and may allow for a simpler and more rapid deployment of the IMD within the patient.

[0008] In some examples, this disclosure describes a system for both trialing and / or mapping and implantation of an IMD. The example system may deploy and / or collapse the expandable structure of the IMD, e.g., for mapping of a body lumen and / or for determination of a target implantation site for the IMD within the patient. The example system may also be configured to release the expandable structure of the IMD (e.g., in its expanded state) within a body lumen of the patient. The example system may reduce a duration and / or a complexity of the operation by eliminating a need for separate devices and / or systems for trialing and / or mapping and implantation.

[0009] In some examples, this disclosure is directed to a medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes.

[0010] In some examples, this disclosure is directed to a medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen;Docket No. A0012964W001 an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes, wherein the elongated body is configured to be retracted along the longitudinal axis to cause the expandable stent to transition from a collapsed configuration to an expanded configuration, and wherein the expandable stent is configured to, in the expanded configuration, interface with wall tissue of a body lumen of a patient to secure the expandable stent and at least a portion of the elongated lead within the body lumen.

[0011] In some examples, this disclosure is directed to a medical device comprising: an elongated body extending along a longitudinal axis, wherein the elongated body defines a first lumen, and wherein the elongated body defines a first feature at or around a distal end of the elongated body; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent, wherein the expandable stent is coupled to a second feature at or around a proximal end of the elongated body; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes, wherein the first feature is configured to engage with the second feature to secure the expandable stent to the elongated body, and wherein the medical device is configured to release the second feature from the first feature to separate the expandable stent from the elongated body.

[0012] In some examples, this disclosure is directed to a method comprising: advancing a distal portion of a medical device within a body lumen of a patient to a target site within the body lumen, the medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes; causing the expandable stent to transition from a collapsed configuration to an expanded configuration; delivering, via the plurality of electrodes, electrical stimulation signals to tissue of the patient at or around the target site; causing the expandable stent to transitionDocket No. A0012964W001 from the expanded configuration to the collapsed configuration; and retracting the medical device from within the body lumen.

[0013] In some examples, this disclosure is directed to a method comprising: advancing a distal portion of a medical device within a body lumen of a patient to a target site within the body lumen, the medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes; causing the expandable stent to transition from a collapsed configuration to an expanded configuration, wherein when the expandable stent is in the expanded configuration, the expandable stent is configured to contact a surface of the body lumen to secure the expandable stent within the body lumen; retracting the elongated body from within the body lumen; and delivering, via the plurality of electrodes, electrical stimulation signals to tissue of the patient at or around the target site.

[0014] The examples described herein may be combined in any permutation or combination. The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 A is a conceptual diagram illustrating an example trialing system including an example trialing device.

[0016] FIG. IB is a conceptual diagram illustrating an example implantation system including an example implantation device.

[0017] FIG. 2 is a conceptual diagram of an example trialing device of the trialing system of FIG. 1A.

[0018] FIG. 3 is a conceptual diagram of an example implantation device of the implantation system of FIG. IB.

[0019] FIG. 4A is a cross-sectional diagram illustrating an example cross section of the example delivery system of FIG. 3, the cross-section being taken along line A-A of FIG. 3.

[0020] FIG. 4B is a cross-sectional diagram illustrating another example cross section of the example delivery system of FIG. 3, the cross-section being taken along line A-A of FIG. 3.

[0021] FIG. 5 A is a conceptual diagram illustrating an example of an implantable lead.Docket No. A0012964W001

[0022] FIG. 5B is a conceptual diagram illustrating an example of an implantable lead.

[0023] FIG. 6Ais a conceptual diagram illustrating an example expandable structure detachment system.

[0024] FIG. 6B is a conceptual diagram illustrating another example expandable structure detachment system.

[0025] FIG. 6C is a conceptual diagram illustrating another example expandable structure detachment system.

[0026] FIG. 7 is a flowchart illustrating an example trialing technique using an example trialing system.

[0027] FIG. 8 is a flowchart illustrating an example implantation technique using an example trialing system.

[0028] FIG. 9 is a flowchart illustrating an example trialing and implantation technique using an example system.

[0029] Like reference characters denote like elements throughout the description and figures.DETAILED DESCRIPTION

[0030] This disclosure describes devices, systems, and methods relating to delivery of electrical stimulation therapy, such as vagus nerve stimulation (VNS), deep brain stimulation (DBS), and / or sensing one or more patient parameters (e.g., nerve activity from one more nerves, cardiac signals, muscle activation signals, brain signals and / or other physiological parameters, such as impedance, electroencephalogram (EEG), evoked potentials, local field potentials, etc.) The devices, systems, and methods described herein may deliver the electrical stimulation therapy and / or sense patient parameters at an endovascular location or within a body lumen of the patient. Example endovascular locations that can be used for electrical stimulation therapy (e.g., VNS therapy) and / or sensing using the devices described herein include an internal jugular vein (IJV). Example endovascular locations that can be used to access the brain sites for electrical stimulation therapy (e.g., DBS) and / or sensing using the devices described herein include any suitable cranial blood vessel (also referred to herein as a cerebral blood vessel or neurovasculature, which can include a vein or an cranial artery), such as, but not limited to, the thalamostriate vein, the internal cerebral vein, the basal vein of Rosenthal, the inferior sagittal sinus, the superior sagittal sinus, or the anterior choroidal artery.

[0031] VNS has been proposed for use to manage one or more patient conditions, such as to control an inflammatory response in patients. Stimulating the vagus nerve may dampen the inflammatory response and associated cytokine response. In some examples, inflammatoryDocket No. A0012964W001 cytokines are modulated up or down via stimulation. In addition, VNS may limit ischemia reperfusion injury. After a cerebral infarct or stroke, reperfusion therapies (surgery or drugs) are given to restore blood flow. However, due to the restoration of blood, flow induced local damage occurs, including ischemia reperfusion injury. This injury may induce local accumulations of chemical mediators such as reactive oxygen species (ROS) production, inflammatory cytokines, bradykinin, etc., which can further affect inflammation. Such inflammatory compounds may trigger sensory signaling, which can lead to a reduced organ vagus activity and sympathetic overdrive. Vagus nerve stimulation may treat reperfusion damage as the inflammatory state may be lowered by increasing parasympathetic drive. VNS has also been shown to improve stroke rehabilitation via its ability to increase the brain’s production of chemicals such as Norepinephrine and Acetylcholine, both associated with neuroplasticity.

[0032] DBS has been proposed for use to manage one or more patient conditions. For example, DBS can be used to alleviate, and in some cases, eliminate symptoms associated with movement disorders, other neurodegenerative impairment, seizure disorders, psychiatric disorders (e.g., mood disorders), or the like. Movement disorders may be found in patients with Parkinson’s disease, multiple sclerosis, and cerebral palsy, among other conditions, and can be associated with disease or trauma. DBS can be delivered endovascularly to one or more target sites in a brain of a patient to help a patient with muscle control and minimize movement problems, such as rigidity, bradykinesia (i.e., slow physical movement), rhythmic hyperkinesia (e.g., tremor), nonrhythmic hyperkinesia (e.g., tics) or akinesia (i.e., a loss of physical movement).

[0033] In the case of seizure disorders, DBS can be delivered endovascularly to one or more target sites in a brain of a patient to reduce the frequency or severity of seizures, or even help prevent the occurrence of seizures. In the case of psychiatric disorders, DBS can be delivered endovascularly to help minimize or even eliminate symptoms associated with major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, or obsessive-compulsive disorder (OCD). DBS delivered endovascularly can also reduce the symptoms of Parkinson’s disease, dystonia, or cerebellar outflow tremor.

[0034] While this disclosure primarily describes examples of VNS and / or sensing via applicable endovascular locations (e.g., the internal jugular vein), it should be understood that the devices, systems, and techniques may be adapted for DBS delivered endovascularly, other kinds of brain stimulation, peripheral nerve stimulation, or electrical stimulation and / or sensing of any nerve tissue that can be done via an endovascular location or within a body lumen of the patient.Docket No. A0012964W001

[0035] FIG. 1 A is a conceptual diagram illustrating an example trialing system 100A including an example trialing device 104A. Trialing device 104A may be configured to be disposed within a body lumen 110 (e.g., a blood vessel) of patient 102. External signal generator 113 may be coupled to a trialing device 104 A.

[0036] Trialing device 104A may extend from distal end 108 A to proximal end 108B. Distal end 108 A of trialing device 104A may include an expandable structure 111 (e.g., an expandable stent) with a plurality of electrodes (not pictured in FIG. 1 A) disposed over expandable structure 111. Proximal end 108B may be coupled to or affixed to external signal generator 113 (e.g., may be inserted within a port of external signal generator 113). One or more elongated leads may extend along the length of trialing device 104 A through one or more elongated tubes within trialing device 104A. The one or more elongated tubes may include, but is not limited to, a multi -lumen elongated tube, e.g., for retention of two or more elongated leads within a same elongated tube. The one or more elongated leads may electrically connect each electrode of the plurality of electrodes on trialing device 104Ato circuitry of external signal generator 113 (e.g., to a corresponding channel of external signal generator 113).

[0037] In the example shown in FIG. 1 A, trialing device 104A is configured to deliver electrical stimulation therapy (e.g., VNS) from external signal generator 113 to a vagus nerve 112 of patient 102 and / or sense bioelectrical signals via electrode(s) on expandable structure 111. In some examples, trialing device 104A is configured to deliver electrical stimulation therapy (e.g., DBS) endovascularly to the brain of patient 102 from external signal generator 113 and / or sense bioelectrical brain signals in the brain endovascularly via electrode(s) on expandable structure 111.

[0038] During a trialing procedure, a clinician may insert a distal portion of trialing device 104 A within the body of patient 102, e.g., to sense one or more parameters of patient 102, to map features within patient 102, to determine a target implantation site for implantable lead, e.g., for implantable lead 104B illustrated in FIG. IB, to deliver temporary stimulation therapy to patient 102, or the like. For example, the clinician may insert trialing device 104A into body lumen 110 of patient 102 and iteratively test different locations within body lumen 110 to determine an optimal target implantation site within body lumen 110 for the most efficacious delivery of stimulation therapy. The clinician may then remove trialing device 104A from within patient 102 and implant a medical device within body lumen 110 at or around the determined target implantation site.

[0039] The clinician may advance trialing device 104A within patient 102 (e.g., within vasculature of patient 102) within a delivery catheter and / or along a guide element extending through trialing device 104A. The clinician may expand and / or collapse expandable structureDocket No. A0012964W001 111 at different locations within body lumen 110, e.g., to re-position trialing device 104 A within body lumen 110 and / or to place electrodes on trialing device 104A within tissue of patient 102. Trialing device 104A may include structures (e.g., a pushable member) to allow for improved pushability of trialing device 104A by the clinician while retaining a flexibility of trialing device 104A at or around distal end 108 A. Trialing device 104A may define a plurality of lumens for retention of elements of trialing system 100 A including, but are not limited to, elongated leads, guide wires, or the like.

[0040] FIG. IB is a conceptual diagram illustrating an example implantation system 100B including an example implantation device 104B. Implantation device 104B may be removably coupled to expandable structure 111 at distal end 109A. Expandable structure 111 may include a plurality of electrodes disposed around an outer surface of expandable structure 111. The plurality of electrodes are configured to be electrically coupled to an implantable medical device (IMD) 114 (e.g., an endovascular IMD) via one or more elongated leads affixed to expandable structure 111. When expandable structure 111 is coupled to implantation device 104B, the one or more elongated leads may be disposed within one or more lumens defined by implantation device 104B.

[0041] The clinician may advance implantation device 104B and expandable structure 111 to body lumen 110 (e.g., within a vasculature of patient 102). Once the clinician determines that expandable structure 111 is at a correct location within body lumen 110 (e.g., at or around a target implantation site), the clinician may cause expandable structure 111 to radially expand outwards (e.g., as illustrated in FIG. IB). Once expanded, expandable structure 111 may place the plurality of electrodes in contact with wall tissue of body lumen 110 and / or may interface with the wall tissue of body lumen 110 to affix expandable structure 111 within body lumen 110. The clinician may then retract implantation device 104B proximally relative to expandable structure 111 and leave expandable structure 111 and the one or more elongated leads within body lumen 110. The clinician may subsequently couple proximal end(s) of the one or more elongated leads to IMD 114 and implant IMD 114 within patient 102. When implanted, IMD 114 may communicate with external computing device 116 to transmit sensed signals to and / or receive instructions (e.g., stimulation therapy parameters) from external computing device 116.

[0042] While FIGS. 1 A and IB illustrate different trialing device 104A and implantation device 104B, respectively, in some examples a single dual-purpose device may perform the function of both trialing device 104 A and implantation device 104B. In such examples, the dualpurpose device may navigate expandable structure 111 and expand and / or contract expandable structure 111 within body lumen 110, e.g., in a same manner as trialing device 104A. Once the clinician determines that expandable structure 111 is at the target implantation site, the clinicianDocket No. A0012964W001 may then actuate the dual-purpose device to separate expandable structure 111 from the dualpurpose device. The clinician may then retract the dual-purpose device and leave expandable structure 111 and accompanying elongated lead(s) within body lumen 110. In such examples, the dual-purpose device may include features of trialing device 104 A and of implantation device 104B in one or more combinations, and may include one or more fixation features to removably secure expandable structure 111 to the dual-purpose device. In some examples, the dual-purpose device may be substantially similar to trialing device 104A or implantation device 104B aside from the addition of the one or more fixation features.

[0043] FIG. 2 is a conceptual diagram of an example trialing device 104A of trialing system 100A of FIG. 1 A. In some examples, trialing device 104A is configured to be retained within a delivery catheter (not pictured in FIG. 2). The delivery catheter may include, but is not limited to, a delivery catheter with an inner diameter of between 2 and lOFrench (Fr.).

[0044] Trialing device 104 A may define an elongated body 202 extending along longitudinal axis 201 from proximal end 108B to distal end 108 A. Elongated body 202 may define an inner volume 204 configured to retain one or more elements of trialing system 100 A. The one or more elements may include, but is not limited to, elongated tube 206 containing elongated lead 210 and guidewire 216 and / or guidewire lumen tube 219. Elongated body 202 may include, but is not limited to, a hypotube (e.g., an elongated hypodermic needle tubing). Elongated body 202 may define an electrically insulated outer surface. Elongated body 202 may define different material properties at different longitudinal locations along the length of elongated body 202. For example, a proximal portion of elongated body 202 at or around proximal end 108B of trialing device 104 A may exhibit increased pushability, increased stiffness, and / or decreased flexibility compared to a distal portion of elongated body 202 at or around distal end 108 A of trialing device 104A. In such examples, the different material properties may increase the navigability of elongated body 202 within patient 102 (e.g., within the vasculature of patient 102) without compromising the flexibility of a distal portion of elongated body 202 (e.g., in maneuvering around turns in the vasculature). Elongated body 202 may include a heat shrink tubing disposed at or around a distal end of elongated body 202. The heat shrink tubing may be formed from a polymer including, but is not limited to, polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET). The heat shrink tubing may reduce friction between elongated body 202 and a delivery catheter and may improve navigability of trialing device 104A within patient 102.

[0045] Trialing system 100 A may include one or more electrical connectors 212A-B (collectively referred to herein as “electrical connectors 212”). Electrical connectors 212 may include corresponding sets 214A-B (collectively referred to herein as “sets 214”) of electricalDocket No. A0012964W001 contacts at or around a proximal end of electrical connector 212. For example, as illustrated in FIG. 2, first electrical connector 212A may include a first set 214A of electrical contacts and second electrical connector 212B may include a second set 214B of electrical contacts. Each of electrical connectors 212 may contain a plurality of electrically conductive wires (e.g., electrical conductors 224).

[0046] Electrical connectors 212 may be disposed on an elongated lead 210, such as at a proximal end of elongated lead 210. Elongated lead 210 may define a lumen (not pictured in FIG. 2) configured to retain one, two, or three or more separate electrical connectors 212 (e.g., both first electrical connector 212A and second electrical connector 212B). The lumen of elongated lead 210 may extend longitudinally from a proximal end of elongated lead 210 to a distal end of elongated lead 210. Elongated lead 210 is preferably surrounded by a protective jacket, e.g. a flexible, elastomeric polymer. Electrical connector(s) 212 may extend longitudinally along the lumen of elongated lead 210 from the proximal end of elongated lead 210 to the distal end of elongated lead 210. Placing multiple electrical connectors 212 within a single elongated lead 210 may reduce a number of components within inner volume 204 of elongated body 202, e.g., thereby reducing a complexity of trialing device 104A and / or a likelihood of entanglement and / or damage of the components within inner volume 204.Elongated lead 210 may be disposed within an inner lumen 208 of elongated tube 206. In some examples, elongated tube 206 is absent and elongated lead 210 is disposed directly within and extends longitudinally within inner volume 204. Elongated tube 206 may be movable or affixed relative to elongated body 202. In some examples, a filler material is disposed between an inner surface of elongated body 202 and elongated tube 206 (e.g., in inner volume 204). Elongated lead 210 may be movable within elongated tube 206 or may be affixed relative to elongated tube 206.

[0047] Expandable structure 111 may include a structure formed from one or more struts. The struts may define a plurality of longitudinally-adjacent layers. The struts may define a plurality of cells. Expandable structure 111 may define an open-cell or a closed-cell configuration. Within the closed-cell configuration, each strut within one layer of expandable structure 111 may be connected to one or more struts within a longitudinally adjacent layer. Within the open-cell configuration, one or more struts within one layer of expandable structure 111 may not be connected to one or more struts within a longitudinally adjacent layer.Expandable structure 111 may transition between a collapsed configuration and a radially expanded configuration. Expandable structure 111 may include a plurality of electrodes 222 disposed on an outer surface of expandable structure 111 (e.g., on struts of expandable structure 111). The plurality of electrodes 222 may define an electrode array. For example, the pluralityDocket No. A0012964W001 of electrodes 222 may define a plurality of rings of electrodes 222 at different longitudinal locations along expandable structure 111, each ring of electrodes 222 including one or more electrodes 222 disposed at different locations around an outer perimeter of expandable structure 111. In some examples, the plurality of electrodes 222 may define an electrode array of 3X5 electrodes 222. Expandable structure 111 may be affixed to elongated body 202, e.g., at or around a distal end of elongated body 202. Expandable structure 111 may be formed from one or more materials including, but is not limited to, a laser-cut metallic material, a metallic mesh, metallic wire(s), a polymer mesh, polymer fiber(s), polymer strand(s), or the like.

[0048] Each of electrodes 222 may be connected to a corresponding electrical contact on one of sets 214 via a corresponding electrical conductor 224. Electrical conductors 224 may be retained within electrical connectors 212 and within elongated lead 210 along the length of elongated body 202. At a distal end of elongated body 202, electrical conductors 224 may exit elongated lead 210 and be electrically coupled to corresponding electrodes 222. Electrical conductors 224 may be electrically coupled to corresponding electrodes 222 directly or indirectly (e.g., via one or more struts of expandable structure 111).

[0049] Each electrode 222 may be connected to a corresponding electrical contact via a separate electrical conductor 224. Electrical connectors 212 may be inserted into ports on external signal generator 113 to electrically couple electrodes 222 on trialing device 104Ato signal generation circuitry and / or sensing circuitry within external signal generator 113. Each electrical contact on sets 214 may be electrically coupled to a separate channel within external signal generator 113. In such examples, external signal generator 113 may sense signals from and / or deliver signals to tissue of patient 102 via each of electrodes 222 separately and / or via any combination of electrodes 222.

[0050] Trialing system 100A may include a guidewire 216 and / or guidewire lumen tube 219. Guidewire 216 may be configured to be disposed within inner volume 204 of elongated body 202. Guidewire 216 may be disposed within a same or different lumen as elongated tube 206 within inner volume 204. Guidewire 216 may extend from a proximal end 217Ato a distal end 217B. A nose cone 218 may be affixed to guidewire lumen tube 219 at or around distal end 217B. Guidewire 216 may facilitate navigation of trialing device 104A within patient 102 (e.g., within the vasculature of patient 102). Nose cone 218 may define an atraumatic tip to the trialing device 104 A and may aid in navigation of the trialing device 104 A over guidewire 216 within patient 102, e.g., by pushing open valves and preventing a distal end of the trialing device 104A from damaging the lumen wall within the vasculature of patient 102. In some examples, guidewire 216 increases stiffness and pushability of trialing device 104 A, thereby increasing navigability of trialing system 100A within patient 102.Docket No. A0012964W001

[0051] Expandable structure 111 may be affixed to elongated body 202 at or around a distal end of elongated body 202. Expandable structure 111 may be affixed to elongated body 202 via a mechanical element (e.g., a radiopaque marker band), via an adhesive, or the like. The clinician may operate trialing system 100 A to cause expandable structure 111 to transition between the collapsed and expanded configurations, e.g., for placing electrodes 222 in contact with tissue of patient 102 at different locations and / or in different orientations within body lumen 110. The clinician may cause expandable structure 111 to expand or collapse via actuation of a control element. The control element may include, but is not limited to, guidewire 216, guidewire lumen tube 219, elongated tube 206, a delivery catheter (not pictured), or another wire disposed within inner volume 204 of elongated body 202.

[0052] In some examples, expandable structure 111 may be formed from (e.g., struts of expandable structure 111 may be formed from) a shape-memory material such as, but is not limited to, Nitinol. In such examples, trialing device 104Amay be retained within a delivery catheter (not pictured in FIG. 2) and the delivery catheter may retain expandable structure 111 in the collapsed configuration. The clinician may retract the delivery catheter relative to trialing device 104 A to expose expandable structure 111 and cause expandable structure 111 to transition towards the expanded configuration. The clinician may advance the delivery catheter over expandable structure 111 to cause an at least partially expanded expandable structure 111 to transition towards the collapsed configuration.

[0053] In some examples, trialing system 100 A and trialing device 104 A may be configured to perform trialing, sensing, and mapping processes (e.g., as previously described above) and to implant expandable structure 111 within body lumen 110 of patient 102. In such examples, trialing device 104 A may be alternatively referred to as a “dual-purpose device 104 A.” In such examples, the clinician may detach expandable structure 111 from elongated body 202 after determining that electrodes 222 and / or expandable structure 111 are at a target implantation site and affixed within body lumen 110. After separating expandable structure 111 from elongated body 202, the clinician may retract trialing device 104 A from within patient 102, leaving expandable structure 111 and elongated lead 210 within body lumen 110. The clinician may then attach electrical connectors 212 to IMD 104 and implant IMD 104 within patient 102.

[0054] Dual-purpose device 104Amay be otherwise identical or substantially similar to trialing device 104 A, aside from corresponding fixation features on elongated body 202 and expandable structure 111. The fixation features on elongated body 202 and expandable structure 111 may interface to couple expandable structure 111 to elongated body 202. The clinician may separate the fixation features to release expandable structure 111 from elongated body 202 by retraction of a delivery catheter, rotation of elongated body 202 relative to expandable structureDocket No. A0012964W001 Ill, or via actuation of a control element extending within inner volume 204 of elongated body 202.

[0055] FIG. 3 is a conceptual diagram of an example implantation device 104B of the implantation system 100B of FIG. IB. The components of implantation device 104B and of implantation system 100B may be substantially similar to the components of trialing device 104 A and of trialing system 100 A previously described herein, aside from the features described below.

[0056] Implantation device 104B may include elongated body 202 defining inner volume 204. Elongated tube 206 defining inner lumen 208 containing elongated lead 210 may be disposed within inner volume 204. One or more electrical connectors 212, each containing a set 214 of electrical contacts, may be disposed within elongated lead 210.

[0057] Expandable element 111 may be disposed at or around a distal end of elongated lead 210. A proximal end of expandable element 111 may be affixed to elongated tube 206 and / or elongated lead 210 (e.g., to a distal end of elongated tube 206 and / or to a distal end of elongated lead 210). Electrical conductors 224 may extend distally from elongated lead 210 and electrically couple electrodes 222 to sets 214 of electrical contacts on electrical connectors 212.

[0058] Guidewire 216 may be disposed within inner volume 204 of elongated body 202. Guidewire 216 may be inserted radially inwards of expandable element 111. Nose cone 218 may be disposed on distal end 217A of may be affixed to a guidewire lumen tube 219.Guidewire 216 may be configured to freely advanced distally or retracted proximally within expandable element 111. Nose cone 218 may be configured to be withdrawn proximally from expandable element 111.

[0059] Elongated body 202 may define a radiopaque distal cap 302. Distal cap 302 may define one or more openings. The one or more openings may include, but is not limited to, first opening 304 and second opening 306. First opening 304 may be sized to facilitate travel of elongated lead 210 through first opening 304. In some examples, as illustrated in FIG. 3, first opening 304 may be sized to allow for the travel of elongated tube 206 (e.g., containing elongated lead 210) through first opening 304. In some examples, first opening 304 may be integral to or otherwise aligned with elongated tube 206. For example, first opening 304 may be fluidically connected to inner lumen 208 of elongated tube 206. In such examples, elongated tube 206 may be affixed to elongated body 202 and / or to distal cap 302 and elongated lead 210 may move distally or proximally within elongated tube 206. Elongated lead 210 may include a lubricious and / or hydrophilic coating around an outer surface of elongated lead 210, e.g., to reduce friction between elongated lead 210 and elongated tube 206.Docket No. A0012964W001

[0060] Second opening 306 may be sized to permit travel of guidewire 216 and / or guidewire lumen tube 219 through second opening 306. Second opening 306 may be circumferentially and / or radially offset from first opening 304 and / or any other openings through distal cap 302. When guidewire lumen tube 219 is disposed within second opening 306, at least a portion of guidewire lumen tube 219 may form a seal with the edges of second opening 306, e.g., to inhibit travel of fluid into or out of inner volume 204.

[0061] Distal cap 302 may include one or more other openings in addition to first opening 304 and second opening 306. The one or more other openings may be configured to retain one or more other features of implantation system 100B including, but are not limited to, a control element releasably secured to a proximal portion of the expansion element 11 l(e.g., to control expansion and / or contraction of expansion element 111), one or more sensing elements, a guide element, or the like.

[0062] The clinician may cause expansion element 111 to transition from the collapsed configuration into the expanded configuration at or around a target implantation site within body lumen 110, e.g., in accordance with one or more techniques previously described herein. The clinician may withdraw guidewire 216 from within implantation device 104B prior to, during, or after expansion of expansion element 111. Expansion of expansion element 111 may place electrodes 222 in contact with a vessel wall of body lumen 110 and / or secure expansion element 111 within body lumen 110.

[0063] Once expansion element 111 has been expanded within body lumen 110, the clinician may then release the control element from the proximal portion of the expansion element 11 land retract implantation device 104B from within body lumen 110. As the clinician retracts implantation device 104B, including a control element, proximally (e.g., along longitudinal axis 201), expansion element 111 may remain in place within body lumen 110. Elongated lead 210 may be coupled to expansion element 111 and may similarly remain in place within body lumen 110. First opening 304 may allow for the retraction of implantation device 104B around elongated lead 210, e.g., thereby exposing elongated lead 210 within body lumen 110. As implantation device 104B is retracted, dimensions between elongated lead 210 and the outer edges of first opening 304 may inhibit a flow of body fluid into inner volume 204 of elongated body 202.

[0064] Once implantation device 104B is fully retracted, expansion element 111 and elongated lead 210 may remain within body lumen 110. Elongated lead 210 may fluidically and electrically isolate electrical components within elongated lead 210 (e.g., electrical contacts, electrical conductors 224). Once implantation device 104B is retracted, the clinician may insertDocket No. A0012964W001 electrical connectors 212 into corresponding ports in IMD 104 to electrically couple electrodes 222 to circuitry of IMD 104, e.g., for delivery of stimulation signals to tissue of patient 102.

[0065] FIG. 4A is a cross-sectional diagram illustrating an example cross section of implantation system 100B of FIG. 3, the cross-section being taken along line A-A of FIG. 3. FIG. 4B is a cross-sectional diagram illustrating another example cross section of implantation system 100B of FIG. 3, the cross-section being taken along line A-A of FIG. 3.

[0066] In some examples, as illustrated in FIG. 4A, elongated body 202 may include a filler material 402 disposed within inner volume 204. Filler material 402 may increase a stiffness and / or pushability of at least a portion of implantation device 104B (e.g., of at least a portion of elongated body 202). Filler material 402 may include, but is not limited to, a metallic alloy such as platinum, platinum iridium, stainless steel, or the like. Filler material 402 may define one or more lumen extending longitudinally along elongated body 202. The one or more lumens may include, but is not limited to, inner lumen 404, inner lumen 406, and inner lumen 408. Each inner lumen extending through filler material 402 (e.g., each of inner lumens 404-408) may define a cross-sectional shape of, but is not limited to, a circular shape, an oval shape, an elliptical shape, or an obround shape.

[0067] Inner lumen 404 may be configured to retain one or more of elongated tube 206 or elongated lead 210. In some examples, as illustrated in FIG. 4 A, elongated tube 206 may be separate from filler material 402 and may move distally and / or proximally within inner lumen 404. In such examples, a lubricious coating and / or material may be disposed over an inner or outer surface of elongated tube 206 and / or an inner surface of filler material 402 defining inner lumen 404, e.g., to facilitate movement of elongated lead 210 within inner lumen 404. In some examples, elongated tube 206 is absent or is integral to filler material 402 (e.g., elongated tube 206 defines inner lumen 404). In such examples, elongated lead 210 may be separate from elongated tube 206 and may freely move distally and / or proximally within inner lumen 208 of elongated tube 206. In such examples, a lubricious coating and / or material may be disposed over an outer surface of elongated lead 210 and / or over an inner surface of elongated tube 206 defining inner lumen 208. Inner lumen 404 may define a diameter of about 0.3 millimeters (mm) (e.g., about 0.012 inches (in)) to about 15.5 mm (e.g., about 0.61 in). A radiopaque marker may be disposed on or within one or more of elongated lead 210, elongated tube 206, or within inner lumen 404.

[0068] Inner lumen 406 may be configured to retain guidewire 216 and / or guidewire lumen tube 219. Guidewire lumen tube 219 may be separate from filler material 402 and may be configured to move distally and / or proximally within inner lumen 406. Inner lumen 406 may be circumferentially and radially offset from inner lumens 402 and 408, and vice versa. InnerDocket No. A0012964W001 lumen 406 may extend along an entire longitudinal length of elongated body 202. Inner lumen 406 may define a diameter of about 0.25 mm (e.g., about 0.01 in) to about 1.3 mm (e.g., about 0.05 in).

[0069] Inner lumen 408 may be configured to retain control member 410. Control member 410 may be configured to perform one or more functions within implantation system 100B including, but is not limited to, expanding and / or contracting expandable member 111 (e.g., by holding expandable member 111 in place while a delivery catheter is withdrawn and / or advanced over expandable member 111), providing additional structural support for elongated body 202, detaching expandable member 111 from elongated body 202 (e.g., in examples where implantation device 104B is a dual-purpose device, as previously described herein), providing visualization support for the clinician when implantation system 100B is within the body of patient 102, or the like. Control member 410 may be separate from filler material 402 and may freely move distally and / or proximally within inner lumen 408. Inner lumen 408 may define a diameter of about 0. 25 mm (e.g., about 0.01 in) to about 1.0 mm (e.g., about 0.04 in). In some examples, implantation system 100B does not include control member 410 and filler material 402 does not define inner lumen 408.

[0070] In some examples, as illustrated in FIG. 4B, filler material 402 defines inner lumen 412, e.g., instead of inner lumen 404. Inner lumen 412 may define an oblong shaped crosssection. Inner lumen 412 may be configured to retain elongated lead 414. Inner lumen 412 may include a lubricious coating and / or material disposed along an inner surface of filler material 402 defining inner lumen 412. One or more radiopaque markers may be disposed along an inner surface of inner lumen 412. Inner lumen 412 may define a height (e.g., along a minor axis of the cross-section of inner lumen 412) of about 1.5 mm (e.g., about 0.06 in). Inner lumen 412 may define a width (e.g., along a major axis of the cross-section of inner lumen 412) of about 2.8 mm (e.g., about 0.11 in).

[0071] Elongated lead 414 may be retained within inner lumen 412. Elongated lead 414 may be substantially similar to elongated lead 210, aside from the features described below.Elongated lead 414 may be retained within elongated tube 206 and disposed within inner lumen 412. Elongated lead 414 may be surrounded by a protective jacket, e.g. a flexible, elastomeric polymer. In some examples, as illustrated in FIG. 4B, elongated lead 414 is disposed within inner lumen 412 without elongated tube 206. A lubricious coating and / or material may be disposed over an outer surface of elongated lead 414, e.g., to facilitate movement of elongated lead 414 within inner lumen 412. In some examples, one or more radiopaque markers are disposed on or within elongated lead 414.Docket No. A0012964W001

[0072] Elongated lead 414 may define two or more inner lumens 416A-B (collectively referred to herein as “inner lumens 416”). Each of inner lumens 416 may be configured to retain a corresponding electrical connector 212. For example, first electrical conductor 212Amay be disposed within inner lumen 416A and second electrical conductor 212B may be disposed within inner lumen 416B. A cross-sectional shape of elongated lead 414 may be based on a number of electrical connectors 212 disposed within elongated lead 414. For example, as illustrated in FIG. 4B, elongated lead 414 may retain first and second electrical connectors 212A, 212B in first and second inner lumens 416A, 416B, respectively. In such examples, elongated lead 414 may define an obround cross-sectional shape. Each of electrical connectors 212 is electrically isolated from other electrical connectors 212, e.g., via a body of elongated lead 414.

[0073] FIG. 5Ais a conceptual diagram illustrating an example of electrical connector 212A of any of FIGS. 2-4B. While FIG. 5 A illustrates one electrical connector 212A, example trialing systems 104A and implantation systems 104B may include two or more substantially similar electrical connectors 212 within the same system. While electrical connector 212Ais illustrated and described herein being coupled to eight electrodes 222, other example electrical connectors may be coupled to more or fewer electrodes 222.

[0074] As illustrated in FIG. 5A, electrical connector 212Amay include a respective set 214Aof electrical contacts 502A-502N (collectively referred to as “electrical contacts 502”) on one end of electrical connector 212A (e.g., on a proximal end of electrical connector 212A). Electrical connector 212A may be coupled to a plurality of electrodes 222 at an opposite end (e.g., at a distal end) by a plurality of electrical conductors 224. Each electrical conductor 224 may electrically couple one or more electrodes 222 to a corresponding electrical contact 502. For example, as illustrated in FIG. 5A, electrode “0” is electrically coupled to electrical contact 502N, electrode “7” is electrically coupled to electrical contact 502A, etc. Each of electrical conductors 224 may extend separately along a longitudinal length of electrical connector 212A.

[0075] A number of electrical contacts 502 within set 214A may be based on a number of electrodes 222. For example, as illustrated in FIG. 5A, electrical connector 212Amay include eight electrodes 222 and eight electrical contacts 502 within set 214A. Each electrical contact 502 may be electrically coupled to a corresponding electrode 222. Electrodes 222 may define an electrode array 504. Electrode array 504 may include an entirety or a portion of the plurality of electrodes 222 disposed on expandable structure 111. In some examples, wherein trialing system 104A and / or implantation system 104B includes two electrical connectors 212, each electrode array 504 may include half of electrodes 222 on expandable structure 111.Docket No. A0012964W001

[0076] Electrodes 222 within electrode array 504 may define two or more sub-arrays 506A, 506B (collectively referred to herein as “sub-arrays 506). Each sub-array 506 may be arranged around a different portion (e.g., a different circumferential portion) of expandable structure 111. Each sub-array 506 may include one, two, or three or more of electrodes 222. For example, as illustrated in FIG. 5A, one sub-array 506 includes electrode “0,” electrode “1,” electrode “2,” and electrode “3” of electrodes 222. Electrodes 222 within each sub-array 506 may be arranged into pairs of electrodes 222, e.g., for placement over expandable structure 111. IMD 114 may sense signals from patient 102 and / or deliver stimulation signals to patient 102 via any combination of electrodes 222, including electrodes 222 from different electrode pairs and / or different sub-arrays 506.

[0077] System 100 Electrodes 222 within different sub-arrays 506 may be arranged at different longitudinal positions along expandable structure 111. For example, electrodes “2” and “3” may be disposed at a more distal position than electrodes “0” and “1” along expandable structure 111. Electrodes 222 within a same electrode pair may be arranged at a substantially similar longitudinal position and at different circumferential positions around expandable structure 111. For example, electrodes “0” and “1” may be disposed at a same or similar longitudinal position along expandable structure 111 and arranged at two separate positions around an outer perimeter of expandable structure 111.

[0078] FIG. 5B is a conceptual diagram illustrating an example electrical connector 508. Electrical connector 508 may be substantially similar to any of electrical connectors 212, aside from the features described below. In some examples, as illustrated in FIG. 5B, all of electrodes 222 on expandable structure 111 are electrically coupled to a single electrical connector 508. Each of electrodes 222 may be electrically coupled to a corresponding electrical contact 502 within set 511 of electrical contacts 502 via a corresponding electrical conductor 224. Electrodes 222 may define an electrode array 510. Electrode array 510 may include all electrodes 222 on expandable structure 111. Electrodes 222 of electrode array 510 may define two or more subarrays 512A-B (collectively referred to herein as “sub-arrays 512”).

[0079] FIG. 6Ais a conceptual diagram illustrating an example expandable structure detachment system 600. Expandable structure detachment system 600 may be incorporated as a part of any of trialing system 100 A or implantation system 100B previously described herein. Expandable structure detachment system 600 may removably couple expandable structure 111 to elongated body 202 (e.g., of trialing device 104A, of implantation device 104B). When expandable structure 111 is coupled to elongated body 202, the clinician may expand, collapse, and / or re-position expandable structure 111 within body lumen 110. For example, expandable structure 111 may remain attached to elongated body 202 when expandable structure 111 isDocket No. A0012964W001 coupled to elongated body 202. Expandable structure 111 may be coupled to elongated body 202, e.g., during trialing of expandable structure 111 within patient 102, during placement of expandable structure 111 at a target implantation site within patient 102. Expandable structure detachment system 600 may be included in a dual-purpose device (e.g., dual-purpose device 104 A) configured to perform both trialing functions and implantation functions.

[0080] Expandable structure detachment system 600 may include a first feature 604 and a second feature 606. First feature 604 may interface with second feature 606 (e.g., may enter into second feature 606 or receive second feature 606) to couple expandable structure 111 to elongated body 202. In some examples, as illustrated in FIG. 6A, first feature 604 includes one or more recesses disposed at or around a distal end of elongated body 202 and second feature 606 includes one or more protrusions coupled to a proximal end of expandable structure 111. In such examples, the one or more protrusions of second feature 606 may enter the one or more recesses of first feature 604 to couple expandable structure 111 to elongated body 202. In some examples, first feature 604 includes one or more protrusions disposed at or around a distal end of elongated body 202 and second feature 606 includes one or more recesses within a proximal portion of expandable structure 111 (e.g., within a collar disposed at or around a proximal end of expandable structure 111). In such examples, the one or more protrusions of first feature 604 may enter the one or more recesses of second feature 606 to couple expandable structure 111 to elongated body 202.

[0081] First feature 604 may interface with second feature 606 to couple expandable structure 111 to elongated body 202. At least a portion of elongated body 202 and expandable structure 111 may be disposed within delivery catheter 602 when expandable structure 111 is coupled to elongated body 202. For example, a distal end of elongated body 202 and a proximal end of expandable structure 111 may be disposed within delivery catheter 602, e.g., to keep expandable structure 111 coupled to elongated body 202. Delivery catheter 602 may constrain first and second features 604, 606 and inhibit movement of second feature 606 out of first feature 604, e.g., thereby causing expandable structure 111 to remain coupled to elongated body 202. For example, as illustrated in FIG. 6A, when delivery catheter 602 is disposed over first and second features 604, 606, delivery catheter 602 may inhibit movement of the one or more protrusions of first feature 604 out of the one or more recesses of second feature 606. Delivery catheter 602 may keep the one or more protrusions of second feature 606 within the one or more recesses of first feature 604, e.g., thereby keeping expandable element 111 coupled to elongated body 202.

[0082] The clinician may retract delivery catheter 602 along elongated body 202 to expose first feature 604 and second feature 606. When first feature 604 and second feature 606 areDocket No. A0012964W001 exposed outside of delivery catheter 602, first feature 604 may separate from second feature 606, thereby separating expandable structure 111 from elongated body 202. For example, as illustrated in FIG. 6A, when first and second features 604, 606 are exposed (e.g., due to retraction of delivery catheter 602), the one or more protrusions of second feature 606 may exit the one or more recesses of first feature 604, e.g., causing expandable structure 111 to separate from elongated body 202.

[0083] FIG. 6B is a conceptual diagram illustrating another example of expandable structure detachment system 600. In some examples, as illustrated in FIG. 6B, expandable structure detachment system 600 may include a first feature 608 extending distally from elongated body 202 and a second feature 610 defined by a proximal end of expandable structure 111.

[0084] First feature 608 may include a protrusion extending distally from a distal end of elongated body 202. The protrusion may extend in-line with elongated body 202. The protrusion may extend along longitudinal axis 201 of elongated body 202. In some examples, the protrusion extends along a reference axis circumferentially offset from and parallel to longitudinal axis 201. First feature 608 may include a looped feature and / or an extension at or around a distal end of the protrusion. In some examples, first feature 608 is a distalmost portion of a control member (e.g., control member 410) disposed within elongated body 202.

[0085] Second feature 610 may include one or more structures (e.g., one or more closed loops, one or more open loops) at or around a proximal end of expandable structure 111. Second feature 610 may be formed from one or more struts of expandable structure 111. Second feature 610 may be formed from a same or different material as expandable structure 111. Second feature 610 may interface (e.g., wrap around, envelop) first feature 608 (e.g., protrusion, looped feature, and / or extension of first feature 608) to couple expandable structure 111 to elongated body 202.

[0086] The clinician may operate one or more of delivery catheter 602 around elongated body 202 and expandable structure 111 and / or a control member within elongated body 202 to separate expandable structure 111 from elongated body 202. In some examples, delivery catheter 602 constrains second feature 610 from unfurling around first feature 608 and expanding radially outwards when delivery catheter 602 is positioned over first and second features 608, 610. The clinician may retract delivery catheter 602 proximally to expose first and second feature 608, 610 and allow second feature 610 to expand away from first feature 608, thereby causing expandable structure 111 and elongated body 202 to separate. In some examples, the clinician may advance the control member disposed within elongated body 202 distally out of one or more of inner volume 204 of elongated body 202 (e.g., out of inner lumen 408 and / or delivery catheter 602 to expose first and second features 608, 610. In such examplesDocket No. A0012964W001 first and second features 608, 610 may become unconstrained and separate, e.g., thereby causing expandable structure 111 and elongated body 202 to separate.

[0087] FIG. 6C is a conceptual diagram illustrating another example expandable structure detachment system 600. In some examples, as illustrated in FIG. 6C, expandable structure detachment system 600 may include a first feature 612 on elongated body 202 and a second feature 614 coupled to expandable structure 111.

[0088] First feature 612 may include a first set of threaded features disposed at or around a distal end of elongated body 202, or a distal end of control element 410. In some examples, as illustrated in FIG. 6C, the first set of threaded features include a first set of male threaded features around a protrusion extending distally at or around a distal end of elongated body 202, or the distal end of control element 410. In some examples, the first set of threaded features include a first set of male threaded features, e.g., at or around an outer surface of elongated body 202, or on the distal end of control element 410. Second feature 614 may include a second set of threaded features configured to interface with the first set of threaded features. The second set of threaded features may include a second set of female threaded features around an inner surface of recess 616 within a protrusion coupled to a proximal end of expandable structure 111, e.g., as illustrated in FIG. 6C. In some examples, the first set of threaded features is female and the second set of threaded features include a second set of male threaded features. The first set of threaded features of first feature 612 may interface with the second set of threaded features of second feature 614 to couple expandable structure 111 to elongated body 202.

[0089] The clinician may couple first feature 612 to second feature 614 to keep expandable structure 111 secured to elongated body 202 within the body of patient 102. At a target implantation site, the clinician may rotate elongated body 202 relative to expandable structure 111 to cause first feature 612 to rotate relative to second feature 614 and disengage from second feature 614, e.g., thereby separating expandable structure 111 from elongated body 202. The clinician may rotate elongated body 202 relative to expandable structure 111 by up to one-quarter, one-half, or one full revolution to separate expandable structure 111 from elongated body 202. In some examples, a control wire (e.g., control element 410) is coupled to and / or define first feature 612. In such examples, the clinician may rotate the control wire relative to expandable structure 111 (e.g., by one or more revolutions) to disengage first feature 612 from second feature 614, e.g., to separate expandable structure 111 from elongated body 202. An amount of force required to rotate elongated body 202 relative to expandable structure 111 may be less than a reactive force exerted by wall tissue of body lumen 110 on an at least partially expanded expandable structure 111, e.g., to inhibit unintended movement of expandableDocket No. A0012964W001 structure 111 within body lumen 110 during detachment of expandable structure 111 from elongated body 202.

[0090] In some examples, after expandable structure 111 is separated from elongated body 202, the clinician may re-couple expandable structure 111 to elongated body 202 via expandable structure detachment system 600. The clinician may rotate first feature 612 into second feature 614 (e.g., via elongated body 202 and / or control element 410) to screw first feature 612 into second feature 614 (or vice versa) and attach expandable structure 111 to elongated body 202.

[0091] Aside from the examples illustrated and described above with respect to FIGS. 6A-6C, expandable structure detachment system 600 may separate expandable structure 111 from elongated body 202 via one or more other techniques. The one or more other techniques may include, but are not limited to, electrolytic detachment or use of a soluble material to attach expandable structure 111 to elongated body 202.

[0092] FIG. 7 is a flowchart illustrating an example trialing technique using an example trialing system 100 A as previously described herein and illustrated in any of FIGS. 1 A-6C. While the technique illustrated in FIG. 7 is primarily described with reference to trialing system 100 A, the technique may be performed using any trialing device 104A and / or via any dualpurpose device described herein. “Trialing” may include, but is not limited to, sensing signals from tissue of patient 102 via trialing system 100A, delivering temporary stimulation to tissue of patient 102 via trialing system 100 A, mapping portions of the body of patient 102 via trialing system 100A, and / or determine a target implantation site for expansion structure 111 within body lumen 110 of patient 102.

[0093] The clinician may navigate a distal portion of trialing system lOOAinto body lumen 110 of patient 102 (702). The distal portion of trialing system lOOAmay include, but is not limited to, elongated body 202 of trialing device 104A, elongated lead 210 disposed within elongated body 202, expandable structure 111 coupled to a distal end of elongated body 202, or the like. Elongated lead 210 may be disposed within an inner lumen in inner volume 204 of elongated body 202 or may be disposed within inner lumen 208 of elongated tube 206 disposed within inner volume 204. In some examples, elongated lead 210 is affixed to elongated body 202 and / or elongated tube 206. In some examples, such as where trialing device 104Ais dualpurpose device 104A, elongated lead 210 may be movable relative to elongated body 202 and / or elongated tube 206.

[0094] Elongated lead 210 may contain one or more electrical connectors 212, each electrical connector 212 containing a plurality of electrical conductors 224. Each electrical conductor 224 may be coupled to one or more electrodes 222 of a plurality of electrodes 222 disposed on expandable structure 111. The plurality of electrodes 222 may define an electrodeDocket No. A0012964W001 array around expandable structure 111 (e.g., one or more electrode arrays 504, electrode array 510). The electrode array may extend around an entire circumference of expandable structure 111 or may extend only partially around the circumference of expandable structure 111. The electrode array may extend along an entire length of expandable structure 111 or may extend along partial lengths of expandable structure 111.

[0095] A proximal portion of elongated lead 210 may extend outside of patient 102 and expose one or more electrical connectors 212 at or around a proximal end of elongated lead 210. The one or more electrical connectors 212 may be inserted into ports on external signal generator 113 to electrically couple electrodes 222 on expandable structure 111 to circuitry (e.g., signal generation circuitry, sensing circuitry, processing circuitry) of external signal generator 113. The electrical connection between circuitry of external signal generator 113 and electrodes 222 may allow for the delivery of electrical signals to and / or the sensing of signals from tissue at or around a target site (e.g., a target nerve such as vagus nerve 112) within patient 102.

[0096] The clinician may insert distal end 108 A of trialing device 104A into a lumen of patient 102 (e.g. through an incision or puncture site accessing a lumen of the patient or through a natural orifice of patient 102). In some examples, such as when trialing system lOOAis configured for endovascular use, the clinician may insert distal end 108A of trialing device 104Ainto vasculature of patient 102, e.g. through a vascular access sheath. In such examples, body lumen 110 may include a blood vessel of patient 102. In other examples (e.g., outside of endovascular use), body lumen 110 may include any other body lumen of patient 102. Distal end 108 A of trialing device 104Amay include expandable structure 111.

[0097] The clinician may advance distal end 108 A of trialing device 104A into body lumen 110 along guidewire 216. Guidewire 216 extend through trialing device 104 A (e.g., through an inner lumen such as inner lumen 406 within trialing device 104 A or through guidewire lumen tube 219). Guidewire lumen tube 219 may include nose cone 218 disposed at or around distal end 217A. Filler material 402 may include nose cone 218 disposed at or around distal end 217A. As the clinician advances trialing device 104 A over guidewire 216 within patient 102 (e.g., within vasculature of patient 102), nose cone 218 may inhibit unintentional penetration of tissue of patient 102. As the clinician advances guidewire 216 within patient 102, nose cone 218 may push open valves, e.g., within veins of patient 102.

[0098] The clinician may advance distal end of guidewire 216 to extend distally of an intended location within body lumen 110. The clinician may then push trialing device 104Ato the intended location along / over guidewire 216. Elongated body 202 may exhibit increased rigidity at or around a proximal end and increased flexibility at or around a distal end. In such examples, the different material properties of elongated body 202 along a longitudinal length ofDocket No. A0012964W001 elongated body 202 may increase pushability of trialing device 104A within patient 102 (e.g., within vasculature of patient 102) and increase flexibility of distal end 108A of trialing device 104A (e.g., for navigation around curves in the vasculature). Trialing device 104A may include filler material 402 within inner volume 204 of elongated body 202, e.g., to improve pushability of trialing device 104 A. In some examples, the control member 410 (e.g., within inner lumen 408) is advanced with elongated body 202. Control member 410 may increase rigidity of at least a portion of trialing device 104 A, e.g., thereby improving pushability of trialing device 104 A.

[0099] The clinician may advance trialing device 104A within delivery catheter 602.Expandable structure 111 may be maintained in a collapsed configuration as the clinician advances trialing system lOOAinto body lumen 110. In some examples, expandable structure 111 is configured to self-expand. In such examples, delivery catheter 602 may maintain expandable structure 111 in the collapsed configuration.

[0100] The clinician may cause expandable structure 111 of trialing system 100 A to expand within body lumen 110 (704) by withdrawing delivery catheter 602 from around expandable structure 111 while stabilizing it by holding control member 410 and / or elongated body 202 stationary. The clinician may cause expandable structure 111 of trialing system lOOAto return to its collapsed configuration within body lumen 110 by advancing delivery catheter 602 over and around expandable structure 111 while stabilizing it by holding control member 410 and / or elongated body 202 stationary. The clinician may rotate and / or move expandable structure 111 within body lumen 110, preferably in a collapsed or partially collapsed condition, until electrodes 222 are at a desired position and / or orientation within body lumen 110 (e.g., until electrodes 222 are aligned with a specific location in body lumen 110). The clinician may determine an orientation of electrodes 222 within body lumen 110 via one or more markers on trialing device 104 A or within trialing system 100 A. The one or more markers may include, but are not limited to, radiopaque markers (e.g., on expandable structure 111, elongated body 202, elongated tube 206, elongated lead 210 etc.) or features (e.g., markers, tabs, wings, etc.) on a handle of trialing device 104 A.

[0101] Once the clinician determines that expandable structure 111 is in a proper position and / or orientation within body lumen 100, the clinician may fully expand expandable structure 111. Once expanded, expandable structure 111 may contact vessel wall of body lumen 110 to secure expandable structure 111 within body lumen 110. Once expandable structure 111 is expanded within body lumen 110, at least one of electrodes 222 on expandable structure 111 may be placed in contact with vessel wall of body lumen 110. In some embodiments, at least one pair of stimulation electrodes and one pair of sensing electrodes are placed in contact with vessel wall of body lumen 110.Docket No. A0012964W001

[0102] In some examples, the clinician retracts delivery catheter 602 to expose expandable structure 111 within body lumen 110. Once exposed, expandable structure 111 may self-expand until expandable structure 111 is in contact with a vessel wall of body lumen 110. In some examples, the clinician actuates control member 410 (e.g., pushes on control member 410 relative to delivery catheter 602 to expand expandable structure 111, or pulls on control member 410 relative to delivery catheter 602 to collapse expandable structure 111).

[0103] The clinician may deliver stimulation signals and / or sense signals via electrodes 222 disposed on expandable structure 111 (706). The clinician may operate external signal generator 113 to deliver electrical stimulation signals to and / or sense signals from tissue of patient 102 (e.g., a target nerve of patient 102) via any combination of one or more electrodes 222 on expandable structure 111 (e.g. stimulation and sensing may be accomplished by at least one pair of stimulation electrodes and one pair of sensing electrodes placed in contact with vessel wall of body lumen 110. The sense signals may include, but are not limited to, signals indicative of one or more physiological parameters of patient 102, or may indicate activation of target nerves or neural pathways by the stimulation electrodes. The clinician may sense signals from patient 102 via electrodes 222 to monitor physiological parameter(s) of patient 102, to map tissue of patient 102 (e.g., to map nerves and / or vasculature of patient 102), and / or to determine a target implantation site within body lumen 110 (e.g., for implantation of expandable structure 111 via implantation device 104A or a dual-purpose device).

[0104] Based on response by patient 102 to delivered signals and / or based on sensed signals from patient tissue, the clinician may re-position expandable structure 111 within body lumen 110. The clinician may further advance expandable structure 111 within body lumen 110, at least partially retract expandable structure 111 within body lumen 110, rotate expandable structure 111 within body lumen 110, and / or position expandable structure 111 within another body lumen. The clinician may at least partially collapse or fully collapse expandable structure 111 (e.g., by holding the control member 410 stationary while advancing delivery catheter 602 over expandable structure 111) to re-position expandable structure 111. Once expandable structure 111 is re-positioned, the clinician may re-expand expandable structure 111 to cause expandable structure 111 and / or electrodes 222 to contact tissue of patient 102.

[0105] Once the clinician has completed the trialing process, the clinician may cause expandable structure 111 to transition into the collapsed configuration (708). The clinician may complete the trialing process by completing sensing of signals from patient 102, completing the mapping of a portion of the body of patient 102, completing the temporary delivery of stimulation signals to target tissue of patient 102, determining a target implantation site for expandable structure 111, or the like. The clinician may cause expandable structure 111 toDocket No. A0012964W001 transition into the collapsed configuration by holding the control member 410 stationary while advancing delivery catheter 602 over expandable structure 111. Once expandable structure 111 is in the collapsed configuration, the clinician may retract trialing system lOOAfrom within body lumen 110 (710).

[0106] FIG. 8 is a flowchart illustrating an example implantation technique using an example implantation system 100B of any of FIGS. 1B-6C. While the technique illustrated in FIG. 8 is primarily described with reference to implantation system 100B, the technique may be performed using any other implantation device 104B and / or via any dual-purpose device described herein. “Implantation” may include, but is not limited to, securing expandable element 111 and elongated lead 210 within the body of patient 102 (e.g., within body lumen 110 of patient 102).

[0107] The clinician may advance a distal portion of implantation system 100B to a target implantation site within body lumen 110 (802). The clinician may advance the distal portion of implantation system 100B to body lumen 110 in a same or similar manner as previously described with respect to trialing system 100A, e.g., in step 702 of FIG. 7. The target implantation site may include, but is not limited to, a location along an inner surface of body lumen 110 for delivery of efficacious stimulation signals to target tissue of patient 102 (e.g., to a target nerve such as vague nerve 112).

[0108] The clinician may cause expandable structure 111 to expand within body lumen 110 (804). The clinician may cause expandable structure 111 to radially expand outward to contact tissue around body lumen 110 at or around the target implantation site. In the expanded configuration, expandable structure 111 may place electrodes 222 in contact with patient tissue, e.g., at or around the target implantation site. In the expanded configuration, expandable structure 111 may interface with an inner surface of body lumen 110, e.g., to affix expandable structure 111 within body lumen 110. The clinician may cause expandable structure 111 to expand, e.g., in accordance with one or more techniques previously described herein with respect to trialing system 100A, e.g., in step 704 of FIG. 7.

[0109] The clinician may retract implantation device 104B from body lumen 110 and leave expandable structure 111 within body lumen 110 (806). Once expandable structure 111 is expanded within body lumen 110, the clinician may retract implantation device 104B proximally and leave expandable structure 111 and elongated lead 210 coupled to expandable structure 111 within body lumen 110. Implantation device 104B may include distal radiopaque cap 302 disposed at or around a distal end of elongated body 202 of implantation device 104B, e.g., to facilitate visibility under fluoroscopy.Docket No. A0012964W001

[0110] Distal cap 302 may include first and second openings 304, 306. Guidewire 216 and / or guidewire lumen tube 219 may be sized to travel through second opening 306. The clinician may retract guidewire 216 into implantation device 104B and / or out of patient 102 through second opening 306. The clinician may retract guidewire 216 prior to expansion of expandable structure 111, after expansion of expandable structure 111, or prior to retraction of implantation device 104B.

[0111] Elongated lead 210 may be sized to travel through first opening 304. First opening 304 may define a same cross-sectional shape as elongated lead 210. For example, elongated lead 210 and first opening 304 may both define circular, elliptical, oval, or obround cross-sectional shapes. As the clinician retracts implantation device 104B, elongated lead 210 may be separated from implantation device 104B via first opening 304 and may remain stationary within body lumen 110 as implantation device 104B is retracted.

[0112] The clinician may electrically couple electrodes 222 on expandable structure 111 to IMD 114 (808). Once implantation device 104B is retracted, the clinician may electrically couple electrical connector(s) (e.g., electrical connectors 212, electrical connector 508) to IMD 114. For example, the clinician may insert each electrical connector into a corresponding port on IMD 114. Each electrical connector may include a set (e.g., one of sets 214, set 511) of electrical contacts 502. When each electrical connector is inserted into the corresponding port on IMD 114, each electrical contact 502 may make contact with a corresponding channel of IMD 114. Each electrical contact 502 may be electrically coupled to a corresponding electrode 222 via electrical conductor 224 extend along a longitudinal length of the electrical connector and / or elongated body 210. Thus, each electrode 222 may be electrically coupled to circuitry of IMD 114 (e.g., sensing circuitry, signal generation circuitry, processing circuitry, etc.) via a corresponding set of electrical conductors 224 and electrical contact 502. When electrodes 222 are coupled to IMD 114, IMD 114 may cause different combinations of electrodes 222 within an electrode array (e.g., electrode array 504, electrode array 510) and / or one or more electrode subarrays (e.g., one or more sub-arrays 506, one or more sub-arrays 512) to sense signals from and / or deliver stimulation signals to target tissue of patient 102 at or around the target implantation site (e.g., to vague nerve 112).

[0113] The clinician may implant IMD 114 within the body of patient 102 (810). The clinician may implant IMD 114 within an endovascular space within patient 102, in a subcutaneous pocket, within the torso of patient 102, or in any other location within patient 102. Elongated lead 210 may travel through one or more body lumen of patient 102 (e.g., through vasculature of patient 102), its proximal portion exiting the body lumen and being implanted inDocket No. A0012964W001 extraluminal tissue, and electrically and mechanically connect expandable structure 111 to IMD 114.

[0114] FIG. 9 is a flowchart illustrating an example trialing and implantation technique using an example system of any of FIGS. 1 A-9. The technique illustrated in FIG. 9 is primarily described with reference to a dual-purpose system, which may include any combination of features from trialing systems lOOAand implantation systems 100B. The dual-purpose system may include any trialing system 100 A or implantation system 100B described herein and may include expandable structure detachment system 600. For example, the dual-purpose system may include a dual-purpose system substantially similar to trialing device 104A and / or to implantation device 104B, with the addition of expandable structure detachment system 600. The dual-purpose system may perform any of the techniques performed by trialing systems 100 A and implantation systems 100B as described herein.

[0115] The clinician may advance a distal portion of a dual-purpose system to a target implantation site within body lumen 110 of patient 102 (902). The clinician may advance the distal portion of the dual-purpose system to the target implantation site in accordance with one or more techniques previously described herein, e.g., with respect to trialing system 100A and / or implantation system 100B.

[0116] The clinician may cause expandable structure 111 to expand within body lumen 110 (904). The clinician may advance the distal portion of the dual-purpose system to the target implantation site in accordance with one or more techniques previously described herein, e.g., with respect to trialing system 100A and / or implantation system 100B.

[0117] The clinician may deliver test stimulation signals and / or sense signals via electrode(s) 222 disposed on expandable structure 111 (906). Electrode(s) 222 may be coupled to an external device (e.g., to external signal generator 113, to external computing device 116) and may transmit test stimulation signals to target tissue at or around the target implantation site and / or transmit sensed signals from the target tissue to the external device.

[0118] The clinician may determine whether electrode(s) 222 are at an intended position within body lumen 110 (908). The intended location may correspond to a location within body lumen 110 where delivery of stimulation signals to tissue at or around the intended location may elicit an efficacious response in patient 102. The clinician may determine whether electrode(s) 222 are at an intended location within body lumen 110 by determining whether sensed signals from tissue at or around electrode(s) 222 and / or patient response to test signals delivered to tissue at or around electrode(s) 222 satisfy one or more threshold conditions. The one or more threshold conditions may include, but are not limited to, sensed impedance values,Docket No. A0012964W001 amplitude(s) of sensed electrical signals, or evoked compound actional potential (ECAP) signals.

[0119] Based on a determination that electrode(s) 222 are not at the intended location (“NO” branch of 908), the clinician may cause expandable structure 111 to transition to a collapsed configuration (910). The clinician may then re-position expandable structure 111 within body lumen 110 (912). The clinician may determine that electrode(s) 222 are not at the intended location based on a determination that the sensed signals and / or the patient response do not satisfy any threshold conditions. The clinician may cause expandable structure 111 to transition to the collapsed configuration and / or re-position and re-expand expandable structure 111 within body lumen 110 in accordance with one or more techniques previously described herein, e.g., with respect to FIG. 7. The clinician may iteratively perform steps 904-912 until the clinician determines that electrode(s) 222 are at the intended location within body lumen 110 (“YES” branch of 908).

[0120] Based on a determination that electrode(s) 222 are at the intended location within body lumen 110 (“YES” branch of 908), the clinician may separate expandable structure 111 from the dual-purpose system (914). The clinician may determine that electrode(s) 222 are at the intended location based on a determination that the sensed signals and / or the patient response do satisfy at least one threshold condition.

[0121] The clinician may engage expandable structure detachment system 600 to separate expandable structure 111 from the dual-purpose system (e.g., from elongated body 202 of the dual-purpose device of the dual-purpose system). Expandable structure detachment system 600 may include a first feature (e.g., first feature 604, first feature 608, first feature 612) on elongated body 202 and a second feature (e.g., second feature 606, second feature 610, second feature 614) on expandable structure 111. The first feature may interface with the second feature to secure expandable structure 111 to elongated body 202.

[0122] In some examples, the dual-purpose device and expandable structure 111 may be disposed within delivery catheter 602, e.g., during delivery of expandable structure 111 to body lumen 110. In such examples, delivery catheter 602 may constrain the first and second features and cause the first feature to remain coupled to the second feature. For example, delivery catheter 602 may keep one or more protrusions of second feature 606 within one or more recesses of first feature 604. In another example, delivery catheter 602 may keep second feature(s) 610 wrapped around and / or enveloping a protrusion, a looped feature, and / or an extension of first feature 608. The clinician may retract delivery catheter 602 around the dualpurpose device to expose the first and second features of expandable structure detachmentDocket No. A0012964W001 system 600 within body lumen 110 and cause the first and second features to separate, e.g., thereby detaching expandable structure 111 from elongated body 202.

[0123] In some examples, the clinician engages a control member (e.g., control member 410) to detach the first feature from the second feature. In some examples, such as when first and second features included threaded features in engagement with each other (e.g., first and second features 612, 614), the clinician may rotate elongated body 202 relative to expandable structure 111 to separate the first and second features, e.g., causing elongated body 202 and expandable structure 111 to separate. In a preferred embodiment, the clinician may rotate control member 410 relative to expandable structure 111 to separate the first and second features, e.g., causing elongated body 202 and expandable structure 111 to separate.

[0124] The clinician may retract dual-purpose system from within body lumen 110 (916). The clinician may retract the dual-purpose system (e.g., the dual-purpose device of the dualpurpose system) from within body lumen 110 in accordance with one or more techniques previously described herein, e.g., with respect step 806 of FIG. 8.

[0125] This disclosure includes the following non-limiting examples.

[0126] Example 1 : a medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes.

[0127] Example 2: the medical device of example 1, wherein the elongated body comprises a hypotube.

[0128] Example 3: the medical device of example 2, wherein the hypotube defines a distal portion and a proximal portion, and wherein the distal portion is more flexible than the proximal portion.

[0129] Example 4: the medical device of any of examples 1-3, wherein a proximal end of the expandable stent is coupled to a distal end of the elongated body.

[0130] Example 5: the medical device of any of examples 1-4, wherein the elongated lead is affixed to an inner surface of first lumen.

[0131] Example 6: the medical device of any of examples 1-5, wherein each electrical connector of the one or more electrical connectors defines one or more electrical contacts at or around a proximal end of the electrical connector, wherein each electrical contact of the one or more electrical contacts is electrically coupled to a different electrode of the plurality ofDocket No. A0012964W001 electrodes, and wherein each electrical contact of the one or more electrical contacts is configured to electrically couple the different electrode to a corresponding channel within an external signal generator.

[0132] Example 7: the medical device of any of examples 1-6, wherein the plurality of electrodes are arranged into one or more levels along a longitudinal length of the expandable stent, and wherein each level of the one or more levels includes at least one electrode of the plurality of electrodes.

[0133] Example 8: the medical device of any of examples 1-7, wherein the expandable stent is self-expandable.

[0134] Example 9: the medical device of any of examples 1-8, further comprising a guidewire disposed within the first lumen, wherein the guidewire defines a nose cone at or around a distal end of the guidewire.

[0135] Example 10: the medical device of any of examples 1-9, wherein the medical device is configured to be inserted within a body lumen of a patient to deliver electrical stimulation signals to tissue of the patient, and wherein the medical device is configured to be removed from within the body lumen after delivery of the electrical stimulation signals.

[0136] Example 11 : the medical device of any of examples 1-10, wherein the medical device is configured to be inserted within a body lumen of a patient to sense electrical signals from tissue of the patient, and wherein the medical device is configured to be removed from within the body lumen after sensing of the electrical signals.

[0137] Example 12: the medical device of any of examples 1-11, wherein the expandable stent comprises an open-celled expandable stent.

[0138] Example 13: the medical device of any of examples 1-11, wherein the expandable stent comprises a close-celled expandable stent.

[0139] Example 14: the medical device of any of examples 1-13, wherein the expandable stent is formed from one or more of: a laser-cut metallic material; a metallic mesh; metallic wires; a polymer mesh; or polymer fibers.

[0140] Example 15: a medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes, wherein the elongated body is configured to be retracted along the longitudinal axis to cause the expandable stent to transition from a collapsed configuration to anDocket No. A0012964W001 expanded configuration, and wherein the expandable stent is configured to, in the expanded configuration, interface with wall tissue of a body lumen of a patient to secure the expandable stent and at least a portion of the elongated lead within the body lumen.

[0141] Example 16: the medical device of example 15, further comprising further comprising a guidewire disposed within the first lumen, wherein the guidewire defines a nose cone at or around a distal end of the guidewire.

[0142] Example 17: the medical device of example 16, wherein the guidewire is configured to be retracted along the longitudinal axis with the elongated body to cause the expandable stent to transition from the collapsed configuration to the expanded configuration.

[0143] Example 18: the medical device of any of examples 15-17, wherein the elongated body is configured to be disposed within a delivery catheter, wherein the expandable stent is distal to a distal end of the elongated body and configured to be disposed within the delivery catheter, and wherein the elongated body comprises a cap at or around the distal end of the sheath, the cap defining an opening sized to retain the elongated lead, and wherein the cap is configured to inhibit flow of body fluids into the first lumen of the elongated body.

[0144] Example 19: the medical device of example 18, wherein the opening comprises a first opening, and wherein the cap defines a second opening sized to retain a guidewire.

[0145] Example 20: the medical device of any of examples 15-19, wherein the elongated body comprises a polytetrafluoroethylene (PTFE) liner along an inner surface of the first lumen.

[0146] Example 21 : the medical device of any of examples 15-20, wherein the first lumen defines a cross-sectional shape of one or more of: a circular shape; an oval shape; an elliptical shape; or an obround shape.

[0147] Example 22: the medical device of any of examples 15-21, further comprising a stylet coupled to the elongated lead, wherein the stylet is configured to support the elongated lead within the elongated body.

[0148] Example 23: the medical device of any of examples 15-22, wherein the expandable stent is coupled to the elongated lead.

[0149] Example 24: the medical device of any of examples 15-23, wherein each electrical connector of the one or more electrical connectors defines one or more electrical contacts at or around a proximal end of the electrical connector, and wherein each electrical contact of the one or more electrical contacts is electrically coupled to a different electrode of the plurality of electrodes.

[0150] Example 25: the medical device of any of examples 15-24, wherein the plurality of electrodes are arranged into one or more levels along a longitudinal length of the expandableDocket No. A0012964W001 stent, and wherein each level of the one or more levels includes at least one electrode of the plurality of electrodes.

[0151] Example 26: the medical device of any of examples 15-25, wherein the expandable stent is self-expandable.

[0152] Example 27: the medical device of any of examples 15-26, wherein the expandable stent comprises an open-celled expandable stent.

[0153] Example 28: the medical device of any of examples 15-26, wherein the expandable stent comprises a close-celled expandable stent.

[0154] Example 29: the medical device of any of examples 15-28, wherein the expandable stent is formed from one or more of: a laser-cut metallic material; a metallic mesh; metallic wires; a polymer mesh; or polymer fibers.

[0155] Example 30: a medical device comprising: an elongated body extending along a longitudinal axis, wherein the elongated body defines a first lumen, and wherein the elongated body defines a first feature at or around a distal end of the elongated body; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent, wherein the expandable stent is coupled to a second feature at or around a proximal end of the elongated body; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes, wherein the first feature is configured to engage with the second feature to secure the expandable stent to the elongated body, and wherein the medical device is configured to release the second feature from the first feature to separate the expandable stent from the elongated body.

[0156] Example 31 : the medical device of example 30, further comprising an elongated wire, wherein the elongated wire is configured to engage with one or more of the first feature or the second feature to separate the first feature from the second feature.

[0157] Example 32: the medical device of example 31, wherein the elongated body defines a third lumen, wherein the third lumen is different from the first lumen, and wherein the elongated wire is configured to be disposed within the third lumen.

[0158] Example 33: the medical device of any of examples 30-32, wherein the first feature comprises a slot on an outer surface of the elongated body, wherein the second feature comprises an extension on the expandable stent, and wherein the extension is configured to enter and engage with the slot to secure the expandable stent to the elongated body.

[0159] Example 34: the medical device of example 33, wherein the medical device is configured to be disposed within a delivery catheter, and wherein when medical device isDocket No. A0012964W001 disposed within the delivery catheter, the delivery catheter is configured to retain the extension within the slot.

[0160] Example 35: the medical device of example 34, wherein when the medical device is advanced out of the delivery catheter, the extension is configured to exit the slot to separate the expandable stent from the elongated body.

[0161] Example 36: the medical device of any of examples 30-35, wherein the first feature comprises a protrusion extending distally from the distal end of the elongated body, wherein the second feature comprises the proximal end of the elongated body, and wherein the proximal end of the elongated body is configured to fold around the protrusion to secure the expandable stent to the elongated body.

[0162] Example 37: the medical device of example 36, wherein the medical device is configured to be disposed within a delivery catheter, and wherein when medical device is disposed within the delivery catheter, the delivery catheter is configured retain the proximal end of the elongated body around the protrusion.

[0163] Example 38: the medical device of any of examples 30-37, wherein the first feature comprises a first threaded feature, wherein the second feature comprises a second threaded feature, and wherein the first threaded feature interfaces with the second threaded feature to secure the expandable stent to the elongated body.

[0164] Example 39: the medical device of example 38, wherein the first threaded feature is configured to be rotated relative to the second threaded feature to release the expandable stent from the elongated body.

[0165] Example 40: the medical device of any of examples 30-39, wherein the first feature comprises a wire, wherein the second feature comprises the proximal end of the expandable stent, and wherein the wire is configured to be separated from the proximal end of the expandable stent via electrolytic detachment.

[0166] Example 41 : the medical device of any of examples 30-70, wherein the elongated body comprises a hypotube.

[0167] Example 42: the medical device of example 41, wherein the hypotube defines a distal portion and a proximal portion, and wherein the distal portion is more flexible than the proximal portion.

[0168] Example 43: the medical device of any of examples 30-42, wherein each electrical connector of the one or more electrical connectors defines one or more electrical contacts at or around a proximal end of the electrical connector, and wherein each electrical contact of the one or more electrical contacts is electrically coupled to a different electrode of the plurality of electrodes.Docket No. A0012964W001

[0169] Example 44: the medical device of any of examples 30-43, wherein the plurality of electrodes are arranged into one or more levels along a longitudinal length of the expandable stent, and wherein each level of the one or more levels includes at least one electrode of the plurality of electrodes.

[0170] Example 45: the medical device of any of examples 30-44, wherein the expandable stent is self-expandable.

[0171] Example 46: the medical device of any of examples 30-45, further comprising a guidewire disposed within the first lumen, wherein the guidewire defines a nose cone at or around a distal end of the guidewire.

[0172] Example 47: the medical device of any of examples 30-46, wherein the expandable stent comprises an open-celled expandable stent.

[0173] Example 48: the medical device of any of examples 30-46, wherein the expandable stent comprises a close-celled expandable stent.

[0174] Example 49: the medical device of any of examples 30-48, wherein the expandable stent is formed from one or more of: a laser-cut metallic material; a metallic mesh; metallic wires; a polymer mesh; or polymer fibers.

[0175] Example 50: a method comprising: advancing a distal portion of a medical device within a body lumen of a patient to a target site within the body lumen, the medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes; causing the expandable stent to transition from a collapsed configuration to an expanded configuration; delivering, via the plurality of electrodes, electrical stimulation signals to tissue of the patient at or around the target site; causing the expandable stent to transition from the expanded configuration to the collapsed configuration; and retracting the medical device from within the body lumen.

[0176] Example 51: the method of example 50, wherein the medical device further comprises elements of any of examples 2-14.

[0177] Example 52: a method comprising: advancing a distal portion of a medical device within a body lumen of a patient to a target site within the body lumen, the medical device comprising: an elongated body extending along a longitudinal axis, the elongated body defining a first lumen; an elongated lead disposed within the first lumen of the elongated body, whereinDocket No. A0012964W001 the elongated lead defines a second lumen; an expandable stent; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes; causing the expandable stent to transition from a collapsed configuration to an expanded configuration, wherein when the expandable stent is in the expanded configuration, the expandable stent is configured to contact a surface of the body lumen to secure the expandable stent within the body lumen; retracting the elongated body from within the body lumen; and delivering, via the plurality of electrodes, electrical stimulation signals to tissue of the patient at or around the target site.

[0178] Example 53: the method of example 52, wherein the medical device further comprises elements of any of examples 16-29.

[0179] Example 54: a method comprising: advancing a distal portion of a medical device within a body lumen of a patient to a target site within the body lumen, the medical device comprising: an elongated body extending along a longitudinal axis, wherein the elongated body defines a first lumen, and wherein the elongated body defines a first feature at or around a distal end of the elongated body; an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen; an expandable stent, wherein the expandable stent is coupled to a second feature at or around a proximal end of the elongated body; a plurality of electrodes disposed on the expandable stent; and one or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes, and wherein the first feature is configured to engage with the second feature to secure the expandable stent to the elongated body; causing the expandable stent to transition from a collapsed configuration to an expanded configuration; delivering, via the plurality of electrodes, test electrical signals to tissue of the patient at or around the target site; selecting, based at least in part on patient response to the test electrical signals, the target site as an implantation for the expandable stent; causing the first feature to separate from the second feature to separate the elongated body from the expandable stent; and retracting the elongated body from within the body lumen of the patient.

[0180] Example 55: the method of example 54, wherein the medical device further comprises elements of any of examples 30-49.

[0181] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

Docket No. A0012964W001WHAT IS CLAIMED IS:

1. A medical device comprising:an elongated body extending along a longitudinal axis, wherein the elongated body defines a first lumen, and wherein the elongated body defines a first feature at or around a distal end of the elongated body;an elongated lead disposed within the first lumen of the elongated body, wherein the elongated lead defines a second lumen;an expandable stent, wherein the expandable stent is coupled to a second feature at or around a proximal end of the elongated body;a plurality of electrodes disposed on the expandable stent; andone or more electrical connectors extending through the second lumen, wherein each electrical connector of the one or more electrical connectors is electrically coupled to one or more electrodes of the plurality of electrodes,wherein the first feature is configured to engage with the second feature to secure the expandable stent to the elongated body, andwherein the medical device is configured to release the second feature from the first feature to separate the expandable stent from the elongated body.

2. The medical device of claim 1, further comprising an elongated wire, wherein the elongated wire is configured to engage with one or more of the first feature or the second feature to separate the first feature from the second feature.

3. The medical device of claim 2, wherein the elongated body defines a third lumen, wherein the third lumen is different from the first lumen, and wherein the elongated wire is configured to be disposed within the third lumen.

4. The medical device of any of claims 1-3, wherein the first feature comprises a slot on an outer surface of the elongated body, wherein the second feature comprises an extension on the expandable stent, and wherein the extension is configured to enter and engage with the slot to secure the expandable stent to the elongated body.Docket No. A0012964W001 5. The medical device of claim 4, wherein the medical device is configured to be disposed within a delivery catheter, and wherein when medical device is disposed within the delivery catheter, the delivery catheter is configured to retain the extension within the slot.

6. The medical device of claim 5, wherein when the medical device is advanced out of the delivery catheter, the extension is configured to exit the slot to separate the expandable stent from the elongated body.

7. The medical device of any of claims 1-6, wherein the first feature comprises a protrusion extending distally from the distal end of the elongated body, wherein the second feature comprises the proximal end of the elongated body, and wherein the proximal end of the elongated body is configured to fold around the protrusion to secure the expandable stent to the elongated body.

8. The medical device of claim 7, wherein the medical device is configured to be disposed within a delivery catheter, and wherein when medical device is disposed within the delivery catheter, the delivery catheter is configured retain the proximal end of the elongated body around the protrusion.

9. The medical device of any of claims 1-8, wherein the first feature comprises a first threaded feature, wherein the second feature comprises a second threaded feature, and wherein the first threaded feature interfaces with the second threaded feature to secure the expandable stent to the elongated body.

10. The medical device of claim 9, wherein the first threaded feature is configured to be rotated relative to the second threaded feature to release the expandable stent from the elongated body.

11. The medical device of any of claims 1-10, wherein the first feature comprises a wire, wherein the second feature comprises the proximal end of the expandable stent, and wherein the wire is configured to be separated from the proximal end of the expandable stent via electrolytic detachment.

12. The medical device of any of claims 1-11, wherein each electrical connector of the one or more electrical connectors defines one or more electrical contacts at or around aDocket No. A0012964W001 proximal end of the electrical connector, and wherein each electrical contact of the one or more electrical contacts is electrically coupled to a different electrode of the plurality of electrodes.

13. The medical device of any of claims 1-12, wherein the plurality of electrodes are arranged into one or more levels along a longitudinal length of the expandable stent, and wherein each level of the one or more levels includes at least one electrode of the plurality of electrodes.

14. The medical device of any of claims 1-13, further comprising a guidewire disposed within the first lumen, wherein the guidewire defines a nose cone at or around a distal end of the guidewire.

15. The medical device of any of claims 1-14, wherein the expandable stent is formed from one or more of:a laser-cut metallic material;a metallic mesh;metallic wires;a polymer mesh; orpolymer fibers.

Images