Apparatus and method for electrotherapy and / or electrophysiology

Abstract

A kit including a device 1 and a delivery system for electrotherapy and / or electrophysiology, and a method for the device. The device 1 includes a lead 2 and a paddle 5 including at least one electrode 8, the paddle 5 being reconfigurable between an operational configuration and a delivery configuration of a smaller transverse extent. The delivery system includes a flexible, hollow outer sheath 28 and a hollow delivery sheath 100 for receiving at least the paddles 5 of the device 1 in the delivery configuration. The delivery sheath 100 may be inserted into a proximal end of the outer sheath 28 and delivered through the outer sheath 28 to deliver the paddles 5 of the device 1 to a distal end of the outer sheath 28 disposed at or oriented toward an implantation site within a patient's body 11. The delivery sheath 100 protects the paddles 5 during delivery and allows for improved control of the position and orientation of the paddles 5 as they are deployed.

Description

[Technical field]

[0001] The present invention relates to devices for electrotherapy and / or electrophysiology, and systems and methods for delivering such devices into a patient's body, for example adjacent to the spinal cord. In particular, the devices may be used as part of a stimulator for electrotherapy or as part of a monitor for electrophysiology. Applications include neuromodulation therapy, neuromonitoring, neuroprosthetics and brain-machine interfaces. [Background technology]

[0002] Minimally invasive surgical procedures for the delivery of implantable devices into the human body are generally known in the art, for example, using an interventional catheter to access a target anatomy, such as through the portal vein.

[0003] It is also known to deploy implantable devices that can reduce in radial size when in a delivery configuration for fitting into the lumen of an interventional catheter, and finally, can increase in radial size when reaching the implantation site. These known implantable devices are generally controlled by control wires that extend throughout the longitudinal lumen of the catheter to allow an operator, typically a surgeon or other clinician, to control the deployment of the implantable device from a control station located outside the patient's body, e.g., a catheter handle.

[0004] Shape memory materials, e.g., shape memory alloys such as Nitinol and / or shape memory crosslinked polymers, are also commonly used for biomedical implants and have the ability to recover their original shape when subjected to appropriate thermal stress. For example, self-expanding stent-grafts and other radially expandable implantable structures are typically formed from Nitinol because of its property of self-expanding when implanted in biological structures due to an increase in temperature within the patient's body. Shape memory crosslinked polymers typically achieve the shape memory effect by a melting transition from a hard phase to a soft phase, essentially like a glass material. Superelastic materials, commonly referred to as pseudoelastic materials, are also known in the art and exhibit the ability to undergo extremely large elastic reversible deformations without the need for thermal activation to achieve their original shape.

[0005] In the art of electrophysiology, it is known to provide implantable electrodes for detecting electrical activity in biological structures. For example, electrical activity in the brain can be detected by needle electrodes inserted into the patient's scalp. A control unit including a recording device is typically associated with the implantable electrodes for recording and filtering the detected signals, e.g., electrocorticographic signals.

[0006] Implantable electrodes for electrical therapy are also known in the art. For example, artificial cardiac pacing is commonly achieved by implantation of an active device capable of delivering stimulation patterns to the contractile tissue of the heart to control the heart rate.

[0007] In the technical field of neuromodulation, implantable electrodes are used to induce controlled changes in the function of neural tissue by applying specific electrical and / or magnetic stimulation patterns. Neuromodulation treatments also include applications in functional treatments ranging from drug-resistant epilepsy, chronic headache conditions, bladder and bowel or respiratory control to improving sensory disorders such as hearing (cochlear implants and auditory brainstem prostheses) and vision (retinal implants). For example, peripheral nerve stimulation of the occipital nerve aims to relieve the pain of inertial migraines.

[0008] Furthermore, the technical field of brain-computer interfaces uses implantable electrodes, mainly for neuroprosthetics, to provide bidirectional direct communication between the brain and devices to restore impaired movement, vision and / or hearing. Bidirectional communication requires some implantable electrodes to function as stimulating electrodes to deliver electrical stimulation and some other implantable electrodes as recording electrodes to sense the electrical activity of the target anatomy. Therefore, a plurality of such electrodes is usually arranged in an array format.

[0009] Additionally, implantable electrodes are used in the field of cardiac resynchronization therapy, typically including stimulation electrodes for delivering electrical impulses to the heart and recording electrodes for sensing information about the electrical state and activity of the heart.

[0010] In one example, it is known to implant electrodes for spinal cord stimulation (SCS) aimed at relieving chronic pain. These stimulation electrodes are inserted into the epidural space, which is a channel that runs in the sagittal plane of the patient's body behind the spinal cord along the vertebral foramina of the spinal column.

[0011] As the need is felt to introduce implantable electrodes into a target anatomy for purposes of electrical interaction with tissue of the target anatomy, it is desirable for the electrodes to be implanted through narrow access, which necessarily limits the maximum size of the electrode, usually, but not necessarily, through a percutaneous incision.

[0012] It is known in the art to provide a deployable electrode for biological tissue stimulation that can increase its transverse size when unconstrained by a delivery catheter or a part thereof. Such deployable electrodes usually include a spring for biasing the body of the deployable structure to increase its transverse size upon deployment. For example, US Patent Application No. 2008 / 140152 shows a transversely foldable paddle electrode having an embedded structure body formed from a thin film of a flexible circuit. This solution allows the paddle to deploy after reaching the target tissue. However, due to its high flexibility, this solution results in poor maneuverability when the paddle electrode is unconstrained by a delivery catheter or a part thereof.

[0013] The documents WO2011 / 121017 and EP2553135, in the name of the applicant, disclose techniques for the manufacture of electrically functionalized stretchable articles by embedding nanometer-scale neutral particles under the free surface of an elastic flexible substrate and into the core of the substrate. Furthermore, the document WO2017 / 203441, also in the name of the applicant, describes a technique for connecting an intrinsically stretchable functionalized conductive polymer to a rigid conductor.

[0014] The document US6714822 shows a rigid lead tip with multiple flexible paddle electrodes extending transversely from the lead tip. During delivery through a delivery catheter, the flexible paddle electrodes are folded around the rigid tip. This solution allows the paddle electrodes to be deployed by a pivoting motion of the entire lead about its longitudinal axis. However, the proposed deployment scheme creates torque stresses along the lead during deployment. Furthermore, when in a delivery configuration in a delivery catheter, paddle electrodes including metallic conductive lines cannot bend beyond a certain radius of curvature without compromising the structural integrity of the metal, thus necessitating the provision of void volume in the sheath. Thus, the ratio of the delivery sheath diameter to the paddle width is high.

[0015] In some applications, for example, when paddle electrodes are deployed lateral to the spinal cord, the orientation of the paddles about the longitudinal axis of the lead may be important for the paddle electrodes to stimulate or monitor electrical activity in the correct position. In the system disclosed in U.S. Patent No. 6,714,822, pivoting of the entire lead about its longitudinal axis is used to deploy the electrodes from the delivery configuration, and therefore such pivoting cannot also be used to set the desired orientation of the paddles about the axis.

[0016] The document WO2020 / 201252, in the name of the applicant, discloses a device for electrotherapy and / or electrophysiology comprising at least one lead having an elongated lead body extending along a longitudinal direction, and a paddle including at least one paddle electrode configured for electrical contact with an anatomy in a patient's body. Means are disclosed for electrically connecting the electrodes to the lead, and during delivery of the paddle to the implantation site, the paddle electrode may be configured in an "omega" shape to reduce its transverse size. The paddle may be delivered by sliding the lead through a sheath previously introduced into the patient's anatomy by a percutaneous needle. The sheath must be sufficiently flexible to cause minimal damage when entering and moving through the patient's anatomy, while being sufficiently stiff to overcome high frictional and compressive forces from the patient's tissue when the distal end of the sheath is pushed towards the implantation site. This stiffness limits the maneuverability of the sheath for precise positioning of the paddle electrode. There is also a risk of damaging the electrode when the paddle slides beyond the robust material of the sheath. [Prior art documents] [Patent documents]

[0017] [Patent Document 1] US Patent Application Publication No. 2008 / 140152 [Patent Document 2] WO2011 / 121017 [Patent Document 3] EP2553135 [Patent Document 4] WO2017 / 203441 [Patent Document 5] U.S. Patent No. 6,714,822 [Patent Document 6] WO2020 / 201252 Summary of the Invention [Means for solving the problem]

[0018] The present invention relates to a kit comprising a device for electrotherapy and / or electrophysiology and a delivery system for the device, The device is Lead and a paddle including a paddle electrode having an exposed surface configured to contact an anatomy within a patient's body; the paddle is reconfigurable between a transport configuration and an operating configuration, the transverse extent of the paddle being smaller in the transport configuration than in the operating configuration; The delivery system is a flexible, hollow outer sheath having a proximal end and a distal end; a hollow delivery sheath for receiving at least a paddle of the device in a delivery configuration; The kit provides that the delivery sheath is configured to be inserted into the proximal end of the outer sheath and carried through the outer sheath to deliver the paddles of the device to the distal end of the outer sheath.

[0019] Thus, delivery of the paddles to the implantation site requires sliding the delivery sheath through the outer sheath. The paddles do not need to slide relative to the delivery sheath except during insertion into and ejection from the delivery sheath. Thus, the design and material selection of each component can be optimized for the limited function that each component needs to perform. The outer sheath can be made relatively stiff and strong to withstand the frictional and compressive forces it is exposed to during insertion into the patient's tissue (provided that damage to the tissue is minimized). The delivery sheath can be softer and more flexible to avoid damage to the paddles and paddle electrodes and to accommodate the changing shape of the paddles as they transition between the delivery and working configurations. The soft material also makes the delivery sheath easier to manipulate with minimal damage to the surrounding anatomical structures as it advances from the distal end of the outer sheath toward the implantation site. Additionally, the delivery sheath can have a smaller outer diameter compared to prior art sheaths, making it easier to advance through tighter spaces and overcome obstacles in the anatomy.

[0020] The material of the delivery sheath can also be selected to slide through the outer sheath with minimal friction, although the paddles need not be designed for such sliding contact. Low friction between the delivery sheath and the outer sheath allows the operator to have very clear feedback of the forces experienced and applied within the patient's body while advancing the delivery sheath and paddles within the body, e.g., in the epidural space. This makes the procedure safer compared to prior art where the forces experienced when advancing the sheath towards the implantation site were dominated by compressive forces from adjacent tissue.

[0021] Preferably, the delivery sheath has a proximal end and a distal end. The distal end includes a distal opening through which the paddle can be received and ejected. This contrasts with the prior art, where the paddle is inserted into the proximal end of the sheath and ejected from the distal end of the sheath during implantation and vice versa during removal. Thus, in the prior art, the paddle needs to be designed to be able to fold or unfold when the respective ends of the paddle are compressed by the rim of the sheath. In a preferred embodiment of the present invention, it is always the proximal end of the paddle that is inserted into or ejected from the distal end of the delivery sheath, thus simplifying the design of the paddle.

[0022] The delivery sheath may further include a proximal opening at the proximal end of the delivery sheath through which the device lead may pass. This is a convenient arrangement that allows relative longitudinal movement between the delivery sheath and the lead, so that the paddle is inserted or ejected from the distal end of the delivery sheath. In one application, an operator may receive a packaged device with the lead extending through the proximal opening of the delivery sheath and the paddle not inserted into the distal end of the delivery sheath. Thus, the paddle is not folded into a shipping configuration before use, which may compromise the elasticity or electrical connection of the paddle during storage of the device for extended periods of time. This also allows the operator to visually inspect the paddle before use. The operator then picks up this delivery sheath and holds it while pulling on the proximal end of the lead. This allows the paddle to be folded and inserted into the distal end of the delivery sheath without the operator ever touching the paddle. This has the advantage of avoiding the unpredictable and potentially damaging forces that an operator may exert on the paddle when manually folding it, whilst maintaining sterility as the operator does not touch the paddle itself.

[0023] Preferably, the paddles are configured to automatically adopt the operating configuration when ejected from the delivery sheath. This may be accomplished, for example, by forming the paddles from a resilient material, by embedding springs or other resilient structures in the structure of the paddles, or by the use of shape memory materials. An alternative is to provide an arrangement for changing the configuration of the paddles under the manual control of an operator, for example via mechanical, electrical or hydraulic means. This allows for greater control of the timing of the transition, but also increases the complexity of the device. The ability to use the delivery sheath to precisely position the paddles before they are deployed, according to the present invention, reduces the benefit of such a control arrangement.

[0024] In some embodiments of the invention, the device further comprises a stylet for controlling movement of the lead from outside the body, which allows the operator to push the lead and paddle forward and steer the distal end of the lead towards the implantation site.

[0025] The device may further comprise at least one fluorescent marker, by means of which the orientation of the device may be determined using fluoroscopy. It is an advantage of the use of a delivery sheath according to the invention that the delivery sheath can be rotated within the outer sheath to adjust the orientation of the paddles while the paddles remain at least partially within the delivery sheath. If at least one fluorescent marker is provided on the paddles, the paddles may first be partially ejected from the delivery sheath so that they start to open and the orientation of the device becomes clear. Preferably, at least one fluorescent marker may be provided on the lead so that the orientation of the device is already clear while the paddles remain in the delivery configuration.

[0026] In some embodiments of the invention, the delivery system further includes a substantially rigid, hollow needle for forming a pathway into the patient's body, a guidewire passable through the needle, and a hollow dilator engageable about and movable along the guidewire, with the hollow outer sheath engageable about the dilator for movement along the guidewire with the dilator. These components provide a convenient means for introducing the outer sheath into the body with its distal end at or oriented toward the desired implantation site.

[0027] The present invention relates to a method of delivering a device for electrotherapy and / or electrophysiology into the body of a patient, comprising: The device is Lead and a paddle including a paddle electrode having an exposed surface configured to contact an anatomy within a patient's body; the paddle is reconfigurable between a transport configuration and an operating configuration, the transverse extent of the paddle being smaller in the transport configuration than in the operating configuration; The method is: inserting a flexible, hollow outer sheath into the patient's body such that a distal end of the outer sheath is at or oriented toward an implantation site within the patient's body; inserting at least a paddle of the device into a hollow delivery sheath with the paddle in a delivery configuration; inserting a delivery sheath into a proximal end of the outer sheath and conveying the delivery sheath through the outer sheath to deliver paddles of the device to the distal end of the outer sheath; and expelling the paddle from the delivery sheath.

[0028] Use of this method of delivering the device provides the advantages discussed above in connection with the kit, including ease of use and reduced risk of harm to the patient resulting from the design of the outer sheath and delivery sheath to perform different functions, high maneuverability of the delivery sheath, and clear feedback to the operator of the forces experienced during implantation of the device.

[0029] Preferably, the delivery sheath includes a proximal end and a distal end, and insertion and ejection of the paddles into and from the delivery sheath occur through a distal opening at the distal end of the delivery sheath. The method may further include passing a lead of the device through a proximal opening at the proximal end of the delivery sheath. The paddles preferably automatically adopt their operative configuration when ejected from the delivery sheath.

[0030] The method also includes using a hollow needle to form a passageway into the patient's body; Inserting a guidewire through the needle and orienting the guidewire so that a distal end of the guidewire is at or directed toward the implantation site; may include a preliminary step of withdrawing the needle; The step of inserting the outer sheath comprises: engaging an outer sheath about a hollow dilator; Engaging a dilator over the guidewire; moving the dilator and outer sheath over the guidewire until a distal end of the dilator is at or directed toward the implantation site; and withdrawing the dilator through the outer sheath.

[0031] In some methods according to the invention, the step of expelling the paddle from the delivery sheath includes determining the position or orientation of the paddle by using fluoroscopy to observe at least one fluorescent marker on the device.

[0032] Additionally, in some methods according to the invention, the step of expelling the paddle from the delivery sheath includes rotating the delivery sheath while the paddle is at least partially within the delivery sheath to adjust the orientation of the paddle, which makes it easier to control the orientation of the paddle because the delivery sheath is free to slide circumferentially and longitudinally within the outer sheath, as compared to prior art techniques where adjusting the orientation of the paddle requires rotating the paddle relative to the wall of the outer sheath or relative to the patient's tissue.

[0033] In summary, the present invention provides a device that can provide finely tuned localization of at least one electrode within the anatomy while at the same time being adaptable to a small diameter for delivery within a patient's body.

[0034] The devices used in the present invention are implantable devices: they may be designed to be implanted long term, perhaps permanently, within the anatomy of a patient's body, or they may be designed to be temporarily implanted, for example to assist with surgery being performed on the patient.

[0035] The devices used in the present invention may be suitable for electrotherapy applications such as pain relief, implanted muscle stimulation, treatment of neuromuscular dysfunction, tissue repair, treatment of urinary and fecal incontinence, treatment of male erectile dysfunction, treatment of edema, lymphatic drainage, peripheral nerve stimulation, etc. Implantable devices according to the present invention are particularly, but not exclusively, suitable for spinal cord stimulation.

[0036] The devices used in the present invention may alternatively be suitable for electrophysiology applications such as peripheral nerve recording, cardiac wall recording, electrocorticography, electroencephalography, electromyography and the like.

[0037] The same device may be used for both electrotherapy and electrophysiology applications.

[0038] As used herein, the term "distal" refers to the end of the device that is relatively further from an operator when the device is in use, or the direction away from the operator, and the term "proximal" refers to the end of the device that is relatively closer to the operator when the device is in use, or the direction toward the operator.

[0039] Further features and advantages of the invention will become apparent from the following description of preferred embodiments, which are given by way of example and are not intended to be limiting. [Brief description of the drawings]

[0040] [Figure 1] FIG. 1 is a perspective view of a prior art device showing a first major surface of a paddle. [Diagram 2] FIG. 1 is a perspective view of a prior art device showing the second major surface of the paddle. [Diagram 3] FIG. 2 is a front view of the lead of the device of FIG. 1. [Figure 4] FIG. 4 is a front view of the proximal portion of the lead of FIG. 3 including a control device. [Diagram 5] 1 is a perspective view of an apparatus according to the invention when in a transport configuration; [Figure 6] 1 is a perspective view of an apparatus according to the present invention when in an operational configuration; [Figure 7] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 8] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 9] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 10] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 11] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 12] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 13] 1A-1D illustrate a series of steps in a method of implanting a device in a patient according to the present invention. [Figure 14] FIG. 2 is a partial longitudinal cross-sectional view of a dilator and an outer sheath. [Figure 15] 13A-13C show a paddle being retracted into a delivery sheath in accordance with the present invention. [Figure 16] FIG. 1 is a partial longitudinal cross-sectional view of an apparatus for use in the present invention, including a lead stylet. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] Figures 1 to 4 are taken from document WO2020 / 201252, to which reference is made for their full description.

[0042] They show a distal portion of a device 1 suitable for applications in electrotherapy or electrophysiology, comprising a lead 2 and a paddle 5. One or more further paddles (not shown) may be arranged along the lead 2. The lead 2 comprises an elongate lead body extending along a longitudinal direction XX and comprising a proximal end 3 and a distal end 4. A transverse direction YY is defined as being orthogonal to said longitudinal direction XX.

[0043] In the illustrated device, at least the distal end 4 of the lead 2 comprises a substantially cylindrical body, preferably having a round cross-section centered in said longitudinal direction XX. The distal end 4 of the lead 2 may be tapered to reduce the transverse or radial dimension or extent of the device 1.

[0044] The paddle 5 has a paddle body including two opposing main surfaces 6, 7 defining a paddle thickness therebetween. Preferably, the two opposing main surfaces 6, 7 of the paddle 5 face away from each other. Each of the two opposing main surfaces 6, 7 of the paddle 5 includes a length extending along said longitudinal direction XX and a width extending along a transverse direction YY. Preferably, the paddle thickness is a fraction of the longitudinal size and / or width of each of the main surfaces. For example, the paddle 5 may be in the form of a film or the like.

[0045] The paddle 5 includes at least one paddle electrode 8 having an exposed surface 9 designed to make electrical contact with an anatomical structure 10 within a patient's body 11. For example, the anatomical structure may include biological tissue and / or organs and / or bodily fluids. The exposed surface 9 of the at least one electrode 8 serves as an electrical terminal of the device 1. By providing the at least one electrode 8, the device 1 may provide electrical stimulation to the anatomical structure 10 and / or record electrical activity of the anatomical structure 10.

[0046] In the illustrated device, the at least one paddle electrode 8 includes an exposed surface 9 that functionally emerges from the first major surface 6 of the paddle 5. In other words, the exposed surface 9 of the at least one electrode 8 and the first major surface 6 of the paddle body 5 jointly form the outer surface of the paddle 5. The term "exposed surface that functionally emerges from the first major surface" means that the paddle 5 exhibits the exposed surface 9 of the paddle electrode 8. The exposed surface 9 does not necessarily protrude from the first major surface 6, but in some embodiments of the invention, the exposed surface 9 protrudes from the first major surface 6. The term "exposed surface that functionally emerges from the first major surface" also includes cases where the at least one electrode 8 covers the entire first major surface 6 of the paddle 5 forming the exposed surface 9 and cases where the at least one electrode 8 covers the entire first major surface 6 of a body half of the paddle, e.g., a paddle wing 21. In some embodiments of the invention, the paddle electrode 8 may include an exposed surface 9 that functionally emerges from both the first and second major surfaces 6 , 7 of the paddle 5 .

[0047] The proximal end 3 of the lead 2 includes one or more electrical contacts 35 that are electrically connected to one or more paddle electrodes 8 by electrical conductors (not shown) that extend along the lead 2. The proximal end 3 of the lead 2 may be received in a port 56 in a case 55 of the controller 36 to provide electrical communication between the controller 36 and the electrical contacts 35 of the lead 2 and, in turn, the paddle electrodes 8.

[0048] In some embodiments of the invention, the control unit 36 ​​includes a pulse generator 36. This provides a stimulator assembly for electrotherapy. The pulse generator may be implantable.

[0049] In some embodiments of the invention, the controller 36 includes a memory for storing information about the electrical activity of the patient's anatomy 10, thereby providing a recorder assembly for electrophysiology. The memory may be implantable.

[0050] The lead 2 includes a connection portion 13 near its distal end 4. The connection portion 13 of the lead 2 forms an electrical and mechanical connection with a mating connection portion 15 of the paddle 5 to secure the paddle 5 to the lead 2 and provide electrical communication between the lead 2 and the paddle electrode 8. In the illustrated device, fastening means 37, 38 are provided for mechanically connecting the connection portion 13 of the lead 2 and the mating connection portion 15 of the paddle 5. The fastening means may include an adhesive 37 connecting the connection portion 13 of the lead 2 and the mating connection portion 15 of the paddle 5. Preferably, the adhesive 37 is electrically insulating. The fastening means may further include a plurality of clips 38 for mechanically connecting the connection portion 13 of the lead 2 and the mating connection portion 15 of the paddle 5. Preferably, the plurality of clips 38 apply a compressive force to form an electrical contact between the mutually facing conductive surfaces of the lead 2 and the paddle 5.

[0051] Preferably, the connection portion 13 of the lead 2 radially delimits a longitudinal cavity 18 for hosting a guiding stylet 16, whereby the elongate body of the lead 2, at least in a portion proximal to the distal end 4, is longitudinally hollow. Preferably, the distal end 4 of the lead 2 longitudinally closes said longitudinal cavity 18. The guiding stylet 16 provided in said longitudinal cavity 18 may be used to advance the device 1 into the patient's body 11 and to steer and manipulate the device 1 within the patient's body 11. Preferably, the lead 2 includes a distal free end 58 distinct from the paddle 5 against which the stylet 16 may act, thereby enhancing the maneuverability of the device 1.

[0052] In the illustrated device, the paddle 5 comprises at least one paddle transverse edge 23 delimiting the width of the main faces 6, 7. Between the free edge 23 of the paddle 5 and the mating connection portion 15, a paddle wing 21 is provided which comprises at least a part of the at least one paddle electrode 8. According to a preferred embodiment of the invention, the paddle 5 comprises at least two opposing paddle wings 21, each having a free edge 23.

[0053] Preferably, the at least one paddle wing 21 is capable of varying its orientation relative to the lead 2 to position the exposed surface 9 of the at least one paddle electrode 8 at various distances from the lead 2. Furthermore, the at least one paddle wing 21 is capable of varying its orientation relative to the lead 2 to align the exposed surface 9 of the at least one paddle electrode 8 against a target portion of the anatomy 11. Preferably, the at least one paddle wing 21 is flexible at least in the transverse direction to be able to conform to the shape of a curved portion of the anatomy 11.

[0054] The paddle 5 can assume at least one conveying configuration and at least one operating configuration, and the transverse or radial extent of the paddle 5 in the at least one conveying configuration is smaller than the transverse or radial extent of the same paddle 5 in the at least one operating configuration.

[0055] The term "transverse extent" means the maximum dimension of the paddle in the transverse direction YY, whereas the term "radial extent" means the maximum dimension of the paddle measured in a direction away from the axis XX. Preferably, the transverse extent of the paddle 5 is varied by folding or unfolding the paddle wings 21 along folds which may be generally parallel to the axis XX. The wings 21 of the paddle 5 are exactly two and are opposite each other with respect to said mating connection portion 15 of the paddle 5, and the cross section of the device 1 may take an "omega" shape, in other words a Q-shape, with the wings 21 being flat segments of the omega and the mating connection portion 15 of the paddle 5 being an arched bridge of the omega.

[0056] The paddle 5 or at least one or more paddle wings 21 may be formed from a resilient material that naturally tends to expand towards the operating configuration when the paddle 5 is unconstrained in the delivery configuration. Additionally or alternatively, the device 1 may include at least one biasing structure 24 biasing the paddle 5 towards the operating configuration. The biasing action is preferably a resilient biasing action. The biasing structure 24 may include at least one elongated element 43 forming a closed path, the elongated element 43 being arranged near a transverse edge of the paddle 5. Preferably, the elongated element 43 extends along the free edge 23 of the paddle wing 21. The biasing structure 24 may include one or more reinforcing elements 45 connected to the at least one elongated element 43. Preferably, the one or more reinforcing elements 45 are transversely extending beams. The at least one biasing structure 24 may include at least one wire spring, leaf spring or coil spring. In some embodiments of the invention, the at least one biasing structure 24 may include at least one shape memory element formed from a shape memory material.

[0057] By using such a device 1, it is possible to provide localized and directional stimulation to the biological structure 10 while simultaneously delivering the device 1 to an implantation site inside the patient's body 11 via minimally invasive surgery.

[0058] By using such a device 1, it is possible to provide localized and directional recording of electrical activity of the biological structure 10 while simultaneously delivering the device 1 to an implantation site inside the patient's body 11 by minimally invasive surgery.

[0059] Such a device 1 may be used in combination with a delivery system for implanting the device within the patient's body 11, for removal of the device 1 from the patient's body 11. According to the present invention, the delivery system comprises an outer sheath 28 and a delivery sheath 100. Advantageously, the delivery sheath 100 houses said device 1 when in a delivery configuration during delivery of the paddles 5 of the device 1 to a desired implantation site in the body 11.

[0060] FIG. 5 shows in simplified form a device similar to that in FIGS. 1-4 including a paddle 5 electrically and mechanically coupled near the distal end 4 of the lead 2. The distal free end 58 of the lead 2 extends beyond the paddle 5 to enhance maneuverability of the device 1 by a stylet 16 extending through the lead 2. The lead 2 is surrounded by a delivery sheath 100, which is itself surrounded by an outer sheath 28. The lead 2 can slide parallel to a longitudinal axis XX through the hollow delivery sheath 100, and the delivery sheath 100 can slide parallel to a longitudinal axis XX through the hollow outer sheath 28. It should be understood that all such movements are relative. For example, the lead 2 may slide within the stationary delivery sheath 100; the delivery sheath 100 may slide along the outside of the stationary lead 2; or both the lead 2 and the delivery sheath 100 may move simultaneously.

[0061] The outer sheath 28 is an open tubular structure at both the proximal and distal ends, and is sufficiently rigid so as not to collapse under compressive forces experienced by the outer sheath 28, while being sufficiently flexible to change direction as it is inserted into the patient's body 11. The proximal end may be provided with a grip for an operator to control the outer sheath 28, particularly for inserting the outer sheath 28 into the body 11 and then withdrawing the outer sheath 28. The outer diameter of the outer sheath 28 may taper towards the distal end.

[0062] The delivery sheath 100 is also a tubular structure that can slide within the hollow outer sheath 28. At the distal end, the delivery sheath 100 includes a distal opening 102 that can receive the paddle 5 in a delivery configuration. At the proximal end, the delivery sheath 100 includes a proximal opening 104 through which the lead 2 can pass. The proximal opening 104 can be smaller than the distal opening 102. The proximal opening 104 can include a hub (not shown) to facilitate passage of the lead 2 through the proximal opening 104. The proximal end of the delivery sheath 100 can be provided with additional stiffness, such as a braid or coil, to better transmit torque from the lead 2.

[0063] 5, the distal end of the delivery sheath 100 protrudes beyond the distal end 64 of the outer sheath 28. The longitudinal position of the lead 2 is such that the paddles 5 are partially surrounded by the delivery sheath 100, which constrains the paddles 5 to remain in the delivery configuration. Thus, the paddle wings 21 are folded transversely around the lead 2, and the paddles occupy a small transverse extent 12.

[0064] 6 , the lead 2 has been advanced distally and / or the delivery sheath 100 has been pulled proximally such that the entire length of the paddle 5 now extends beyond the distal opening 102 of the delivery sheath 100. This releases the paddle 5 to adopt an operating configuration with the paddle wings 21 spread to their maximum transverse extent 12.

[0065] Preferably, the paddle 5 is configured to automatically adopt the working configuration upon ejection from the delivery sheath 100, for example, by at least the paddle wings 21 formed from a resilient material or including at least one biasing structure 24, as previously described. Conversely, when the paddle 5 is retracted into the delivery sheath 100, contact between the proximal ends 66 of the paddle wings 21 and the rim of the distal opening 102 of the delivery sheath 100 overcomes the bias of the paddle 5 toward the working configuration and forces the paddle wings 21 to fold inwardly into the delivery configuration so that the paddle wings 21 can extend into the delivery sheath 100. The proximal ends 66 of the paddle wings 21 may be tapered or otherwise shaped in the distal direction to mediate contact between the paddle wings 21 and the distal end of the delivery sheath 100 and provide a smooth transition between the delivery configuration and the working configuration in each direction. The bias of the paddles 5 towards the operating configuration, combined with an appropriate shape of the proximal ends 66 of the paddle wings, may act to aid in the final stages of ejection of the paddles 5 from the delivery sheath 100. Conversely, this may resist the initial stages of retracting the paddles 5 into the delivery sheath 100. As will be explained below, since the paddles 5 are preferably ejected from and inserted into the delivery sheath 100 only through the distal openings 102 of the delivery sheath 100, only the shape of the proximal ends 66 of the paddle wings 21 need be designed with these factors in mind. The distal ends 68 of the paddle wings may be designed with only other considerations in mind, such as the preferred layout of the paddle electrodes 8 and minimization of damage to the patient's biological tissue during movement of the paddles 5.

[0066] The use of the delivery system for implanting the device 1 in the patient's body 11 will now be described with reference to Figures 7 to 13, using the example of implanting a device for Spinal Cord Stimulation (SCS). In SCS, the paddles 5 are implanted in the epidural space 53 adjacent to the spinal cord 54, with the paddle electrodes 8 oriented in electrical communication with the spinal cord. In summary, the main procedural steps are: Insertion of guidewires into the patient Insertion of the outer sheath into the patient Outer sheath advancement -Paddle loading into delivery sheath Delivery sheath advancement -Paddle Orientation Control -Deployment of paddles at target site -Paddle position management Removal of the delivery sheath -Removal of outer sheath It consists of:

[0067] The purpose of the guidewire 70 into the patient is to be a small diameter element that can be inserted first to determine a path and then guide the entry and advancement of the larger diameter dilator 74 and outer sheath 58 to the target location of the outer sheath 28 within the body. The guidewire 70 can be inserted into the patient through an opening in tissue or a device such as, but not limited to, a substantially rigid needle. FIG. 7 shows the insertion of a hollow needle 50, such as a Tuohy needle, through an opening between the vertebrae of the spinal column 52, preferably at a shallow angle (less than 45°). A blade (not shown) may be used to make an initial incision in the patient's skin through which the needle 50 is inserted. The needle 50 is inserted until the opening at the tip of the needle 50 is positioned in the epidural space, facing towards the desired implantation site for the paddle 5.

[0068] 8 shows the insertion of a guidewire 70 through needle 50. Guidewire 70 is pushed so that its distal end extends beyond the tip of needle 50 and travels along epidural space 53 toward the implantation site for paddle 5. Guidewire 70 is sufficiently flexible to change direction as it travels from needle 50 into epidural space 53.

[0069] It may be preferred that the distal tip of the guidewire 70 is bent or curved upon entry into the patient's body 11 to effectively reduce the contact angle between the tip and the tissue compared to a straight tip. This may reduce the force applied directly to the tissue, thereby reducing the tendency to cause localized damage and also reducing the insertion force experienced by the user. Alternatively, the guidewire 70 may be configured with a coil to provide flexibility, combined with an open central lumen at the proximal end of the guidewire. A guidewire stylet (not shown) can be inserted through the lumen to modify the distal shape and overall stiffness of the guidewire. The stylet can have a straight, bent or curved stylet tip and is inserted at the proximal end of the guidewire until the stylet tip reaches the guidewire tip. In this configuration, the guidewire tip takes the shape of the stylet tip. The stylet can then be rotated relative to the guidewire so that the orientation of the curved guidewire tip can be changed relative to the guidewire body to aid in manipulation. When it is desired to push the guidewire 70 along a straight path, the curved stylet may optionally be replaced with a straight stylet.

[0070] When the guidewire 70 is in the desired position, the needle 50 may be withdrawn. The outer sheath 28 is then introduced over the guidewire 70, following the guidewire 70 into the patient's body 11. During introduction into the body 11, the outer sheath 28 is supported by a dilator 74, as shown in FIG.

[0071] The dilator 74 is a long flexible member that fits slidably within the outer sheath 28. The proximal portion of the dilator is designed to be manipulated by the operator. The distal portion 76 of the dilator 74 is preferably shaped such that its cross-sectional area tapers distally. The outer sheath may similarly taper toward the distal end 64. The dilator 74 has a central lumen 78 that extends from the proximal end to the distal end. The distal portion 76 of the dilator 74 is preferably flexible enough to bend, at least through the change in angle at which the guidewire 70 enters the epidural space, but is sufficiently elastic to be forced through an opening in tissue and dilate the opening. The outer sheath 28 fits snugly around the dilator 74. The outer sheath 28 and the dilator 74 can be preassembled or assembled by the operator.

[0072] 9, the guidewire 70 is inserted into the central lumen 78 of the dilator, and the outer sheath 28 and dilator 74 slide along the path defined by the guidewire 70. Once the tip of the dilator 74 passes the point along the path where it first reaches the patient's tissue, the distal portion 76 of the dilator 74 begins to penetrate the surrounding tissue, progressively dilating the surrounding tissue to form a passageway that can accommodate the subsequent insertion of the paddle 5.

[0073] This step of the procedure aims to position the tip 64 of the outer sheath 28 somewhere along the guidewire 70 within the patient. The preferred location of the outer sheath tip 64 may be at the implantation site, adjacent to the implantation site, or oriented toward the implantation site, as described below. The distal end of the outer sheath 28 may include features and materials such that its location can be determined using fluoroscopy. Once the outer sheath 28 reaches the desired location, the dilator 72 and guidewire 70 may be removed, either sequentially or simultaneously, to leave the outer sheath 28 defining a pathway into the patient's body 11, as shown in FIG.

[0074] The next step in the method is to insert the delivery sheath 100 together with the device 1 including the lead 2 and the paddles 5 into the outer sheath 28. The paddles 5 must first be loaded into the delivery sheath 100, which may be done just before the insertion step or at any time earlier. The device 1 may be delivered to the operator with the paddles 5 already housed in the delivery sheath 100. However, to avoid possible damage or loss of elasticity in the paddles 5, it is preferred that the paddles 5 are not stored folded in a shipping configuration for extended periods of time.

[0075] The operator or manufacturer threads the proximal end of the lead 2 through the delivery sheath 100 by first passing it through the opening 102 at the distal end of the delivery sheath 100 and then through the opening 104 at the proximal end of the delivery sheath 100. The lead 2 may then be pulled while remaining in the operational configuration until the paddle 5 is near the distal end of the delivery sheath 100. The combination of the device 1 and the delivery sheath 100 may be conveniently stored in this arrangement for an extended period of time if necessary. Thereafter, while holding the delivery sheath 100, the lead 2 is pulled further until the proximal end 66 of the paddle 5 engages the distal opening 102 of the delivery sheath 100, as shown in FIG. 15. Continued pulling on the lead 2 causes the paddle 5 to gradually collapse into the shipping configuration until it is fully housed within the delivery sheath 100. Preferably, the distal tube 58 of the device 1 remains outside the delivery sheath 100.

[0076] The distal opening 102 of the delivery sheath 100 may have a simple circular rim. Alternatively, the distal opening 102 may include features (not shown) to specifically aid in the folding of the paddle wings 21 when the paddles 5 are received in the delivery sheath 100. Such features may include the shape of the opening 102 and / or materials, such as a flexible, hollow core, within the opening 102 to mediate engagement with the paddle wings 21. These features may be provided on the delivery sheath 100 itself or on a separate paddle loader (not shown) that may be temporarily attached to the distal opening 102 while the paddles 5 are inserted into the delivery sheath 100 and then removed before the delivery sheath 100 is inserted into the outer sheath 28.

[0077] With the paddles 5 loaded into the delivery sheath 100, the delivery sheath 100 is then advanced into the proximal end of the outer sheath 28 and slid through the outer sheath 28 until the delivery sheath 100 emerges from the distal end 64 of the outer sheath 28 within the patient, as shown in Figure 11. This carries the paddles 5 to the distal end 64 of the outer sheath 28, which may be at, adjacent to, or directed toward the target implantation site of the paddles 5.

[0078] At this stage, a lead stylet 90 including a curved tip may be inserted through the lead 2 and into the hollow. Alternatively, it may be possible to insert the lead stylet 90 into the lead 2 before or immediately after the paddles 5 are loaded into the delivery sheath 100. Once seated, the tip of the stylet 90 engages a resilient surface within the lead 2, preferably at the distal free end 58 of the lead. The proximal end of the lead stylet 90 has a finger grip 92 that the operator can use to apply an axial force to the stylet 90, such that the tip of the lead stylet 90 applies force to a contact surface within the lead 2 to advance the lead 2 distally. The lead stylet 90 preferably has a curved tip 94, as shown in FIG. 16, which creates a curve in the paddle distal tube 58. The orientation of the curved paddle distal tube 58 about the longitudinal axis XX of the lead 2 can be controlled by rotating the finger grips 92 of the lead stylet 90.

[0079] With the curved paddle distal tube 58 outside of the delivery sheath 100, the delivery sheath 100 is advanced out of the distal end of the outer sheath 28 toward the desired location at or near the paddle implantation site. Manipulation of the delivery sheath 100 is accomplished by changing the orientation of the curved paddle distal tube 58. In this scenario, the outer sheath 28 remains stationary. It may even be possible to remove the outer sheath 28 from the patient prior to final positioning of the delivery sheath 100.

[0080] Once the delivery sheath 100 reaches a target location just proximal to the desired implantation site of the paddles 5, the lead stylet 90 may be pressed while the delivery sheath 100 is held stationary, causing the paddles 5 to be ejected from the delivery sheath 100, occupy the desired implantation site, and self-expand into the operative configuration as previously described. This is the position shown in FIG. 12. Alternatively, the delivery sheath 100 may be advanced until it reaches a target location at the desired implantation site itself. The delivery sheath 100 may then be withdrawn while the paddles 5 are held stationary, causing the delivery sheath 100 to separate from the paddles 5, leaving the paddles 5 occupying the desired implantation site in the operative configuration.

[0081] Once the paddles 5 are deployed, the position of the paddles 5 can be adjusted as needed to position the paddles 5 at the intended implantation site. The position of the paddles 5 can be adjusted proximally by the operator pulling on the lead 2, and moved distally by the operator pressing on the paddle stylet 90. Any lateral adjustments can be made by repeatedly advancing and retracting the lead 2 while alternating the orientation of the curved distal paddle tube 58.

[0082] The orientation of the paddles 5 may be important for certain medical applications that require the paddle electrodes 8 to be oriented towards a particular location within the patient, for example towards the spinal cord 54 for SCS. Orientation control can be achieved in a number of ways, by one or a combination of the following methods:

[0083] The orientation of the paddles 5 may be controlled while the paddles 5 are folded into the delivery sheath 100. Using X-ray fluoroscopy, the orientation of the radiopaque fluorescent markers 85 on the paddles 5 and / or the lead 2 indicates the orientation of the paddles 5 relative to the patient's anatomy 11. Even when the paddles 5 remain housed in the delivery sheath 100, the markers 85 can still provide information about how the paddles 5 are oriented relative to the patient. If the markers indicate that the paddles 5 are not deployed in the desired orientation, the operator twists the delivery sheath 100 within the outer sheath 28 until the desired marker orientation is reached. The present invention makes this operation particularly easy to perform, since the delivery sheath 100 is specifically designed to slide relative to the outer sheath 28.

[0084] Additionally or alternatively, the orientation of the paddle 5 may be controlled as it is ejected from the delivery sheath 100. As the paddle 5 is slowly pushed out of the delivery sheath 100 (or as the delivery sheath 100 is slowly withdrawn relative to a stationary paddle 5), the paddle 5 begins to open, revealing a fluorescent marker 85 near the distal end of the paddle 5. Since the location of the fluorescent marker 85 is known relative to another radiopaque reference, such as, but not limited to, a ring electrode on the paddle 5, the operator can verify that the paddle 5 is beginning to emerge from the delivery sheath 100 in the desired orientation. To modify the paddle 5, if necessary, the operator can rotate the delivery sheath 100 by twisting the proximal end, which itself rotates the paddle 5, which remains partially within the delivery sheath.

[0085] Finally, the orientation of the paddle 5 may still be controlled after the paddle 5 exits the delivery sheath 100. In this case, the user identifies an incorrect paddle orientation after full deployment from the outer sheath. The user then pulls the paddle 5 back into the delivery sheath 100 sufficiently to achieve sufficient engagement between the paddle 5 and the delivery sheath 100. Friction between the paddle 5 and the delivery sheath 100 then rotates the paddle 5 together with the delivery sheath 100 relative to the outer sheath 28. By assessing the shape and position of the fluoroscopy markers 85 on the paddle 5, the operator can rotate the paddle 5 until the desired fluoroscopy marker configuration is achieved. During this procedure, the operator may wish to repeatedly redeploy and retract the paddle 5 to allow maximum visibility of the fluoroscopy markers 85.

[0086] It will be appreciated that it is not essential (but remains possible) for the distal end 64 of the outer sheath 28 to extend completely to the implantation site of the paddles 5, since the position of the delivery sheath 100 can be controlled after it has exited the distal end 64 of the outer sheath 28, and the position of the paddles 5 can be controlled after it has been deployed from the delivery sheath 100. In particular, it may be desirable that the outer sheath 28 should extend as far into the patient as necessary to form a pathway through resisting tissue, for example, by using a dilator 72 to insert the outer sheath 28. It is preferred if the delivery sheath 100, which is typically narrower and more flexible, can be advanced the remaining distance to the implantation site. For example, in the illustrated example of implanting the device 1 for SCS treatment, it may be sufficient for the outer sheath 28 to be pushed only through the ligamentum flavum until the distal end 64 enters the epidural space 53 and is directed towards the desired implantation site, and then the delivery sheath 100 carrying the paddles 5 can be advanced the remaining distance through the epidural space 53.

[0087] Once the paddles 5 are in place at the implantation site, the delivery sheath 100 may be withdrawn from the patient through the outer sheath 28. The outer sheath 28 may then also be withdrawn from the patient, leaving the device 1 implanted, as shown in FIG. 13. To keep the position of the paddles 5 intact during withdrawal of the delivery sheath 100 and outer sheath 28, the operator may hold the finger grip 92 of the paddle stylet 90 while withdrawing the delivery sheath 100 and outer sheath 28 from the patient. The lead 2 is preferably designed to be long enough that the operator can still hold the finger grip 92 after complete withdrawal of the two sheaths 28, 100 from the patient. Finally, the stylet 90 may be withdrawn from the lead 2 if desired, which releases the delivery sheath 100 and outer sheath 28 to be removed.

[0088] When treatment is completed or when replacement of the device 1 is required, the device 1 must be removed (extracted) from the patient. In one method of extraction, the operator gradually slides the outer sheath 28 distally along the lead 2 until it reaches the desired position. The operator can then gradually slide a removal sheath (not shown) through the outer sheath 28 until it reaches a position near the paddles 5. The removal sheath may be generally similar to the delivery sheath 100. The paddles 5 may then be retracted into the removal sheath by pulling on the proximal end of the lead 2. This causes the paddles 5 to partially or completely collapse into a delivery configuration within the removal sheath. The removal sheath, with the paddles 5 held therein, may then be withdrawn through the outer sheath 28. Finally, the outer sheath is withdrawn from the patient.

[0089] Alternatively, in some circumstances, the paddles 5 may be able to be removed without the use of a sheath by simply pulling on the proximal end of the lead 2. This technique may be particularly relevant after a failed placement or implantation attempt, since the proximal end of the lead 2 still exits the patient's skin.

[0090] Those skilled in the art may make numerous modifications and adaptations to the above-described embodiments or may replace elements with other elements that are functionally equivalent in order to meet unforeseen needs without departing from the scope of the appended claims.

Claims

1. A kit comprising a device (1) for electrotherapy and / or electrophysiology and a delivery system for said device, The device (1) comprises: Lead (2), a paddle (5) comprising a paddle electrode (8) having an exposed surface configured to contact an anatomy (10) within a patient's body (11); the paddle (5) being reconfigurable between a transport configuration and an operating configuration, the transverse extent of the paddle (5) being smaller in the transport configuration than in the operating configuration; The delivery system comprises: a flexible, hollow outer sheath (28) having a proximal end and a distal end; a hollow delivery sheath (100) for receiving at least the paddles (5) of the device (1) in the delivery configuration; The delivery sheath (100) is configured to be inserted into the proximal end of the outer sheath (28) and transported through the outer sheath (28) to deliver the paddles (5) of the device (1) to the distal end of the outer sheath (28).

2. 2. The kit of claim 1, wherein the delivery sheath (100) has a proximal end and a distal end, the distal end having a distal opening (102) through which the paddle (5) can be received and expelled.

3. 3. The kit of claim 2, wherein the delivery sheath (100) further comprises a proximal opening (104) at the proximal end of the delivery sheath (100), through which the lead (2) of the device (1) can pass.

4. 4. The kit of claim 1, wherein the paddles (5) are configured to automatically adopt their operative configuration when ejected from the delivery sheath (100).

5. The kit according to any one of claims 1 to 4, wherein the device (1) further comprises a stylet for controlling movement of the lead (2) from outside the body (11).

6. 6. The kit according to claim 1, wherein the device (1) further comprises at least one fluorescent marker (85) by means of which the orientation of the paddle (5) can be determined using fluoroscopy.

7. The delivery system comprises: a substantially rigid, hollow needle (50) for forming a passageway into the body (11) of the patient; a guidewire (70) capable of passing through said needle (50); a hollow dilator (72) capable of engaging around and moving along the guidewire (70); 7. The kit of claim 1, wherein the hollow outer sheath (28) is capable of engaging around the dilator (72) to move together with the dilator (72) along the guidewire (70).

8. A method for delivering a device (1) for electrotherapy and / or electrophysiology into a patient's body (11), comprising: The device (1) comprises: Lead (2), a paddle (5) comprising a paddle electrode (8) having an exposed surface configured to contact an anatomy (10) within a patient's body (11); the paddle (5) being reconfigurable between a transport configuration and an operating configuration, the transverse extent of the paddle (5) being smaller in the transport configuration than in the operating configuration; The method comprises: inserting a flexible, hollow outer sheath (28) into the patient's body (11) such that a distal end of the outer sheath (28) is at or oriented toward an implantation site within the patient's body; inserting at least said paddles (5) of said device (1) into a hollow delivery sheath (100) with said paddles (5) in said delivery configuration; inserting the delivery sheath (100) into the proximal end of the outer sheath (28) and conveying the delivery sheath (100) through the outer sheath (28) to deliver the paddles (5) of the device (1) to the distal end of the outer sheath (28); and expelling the paddle (5) from the delivery sheath (100).

9. 9. The method of claim 8, wherein the delivery sheath (100) has a proximal end and a distal end, and the paddle (5) is inserted into the delivery sheath (100) and ejected from the delivery sheath (100) through a distal opening (102) at the distal end of the delivery sheath (100).

10. 10. The method of claim 9, further comprising passing the lead (2) of the device (1) through a proximal opening (104) at the proximal end of the delivery sheath (100).

11. 11. The method of any one of claims 8 to 10, wherein the paddles (5) automatically adopt their operative configuration when ejected from the delivery sheath (100).

12. using a hollow needle (50) to form a passageway into the body (11) of the patient; inserting a guidewire (70) through the needle (50) and orienting the guidewire (70) so that a distal end of the guidewire (70) is at or directed toward the implantation site; a preliminary step of withdrawing said needle (50); The step of inserting the outer sheath (28) comprises: engaging the outer sheath (28) around a hollow dilator; Engaging the dilator (72) around the guidewire (70); moving the dilator (72) and the outer sheath (28) along the guidewire (70) until a distal end of the dilator (72) is at or directed toward the implantation site; and withdrawing the dilator (72) through the outer sheath (28).

13. 13. The method according to any one of claims 8 to 12, wherein the step of expelling the paddle from the delivery sheath (100) comprises determining a position or orientation of the paddle (5) by using fluoroscopy to observe at least one fluorescent marker (85) on the device (1).

14. 14. The method according to any one of claims 8 to 13, wherein the step of expelling the paddle (5) from the delivery sheath (100) comprises rotating the delivery sheath (100) while the paddle (5) is at least partially within the delivery sheath (100) to adjust an orientation of the paddle (5).

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