Medical device implantation system

Abstract

One or more examples include a medical device system including: an implantable medical device (IMD) comprising: a distal section comprising a fixation mechanism configured to affix the distal section to wall tissue within a chamber of a heart of the patient; a proximal section configured to be disposed within a blood vessel of the patient; a medial section connecting the distal section to the proximal section; and an interface feature disposed on one or more of the proximal section or the medial section; and an IMD delivery system comprising a tether assembly, wherein the tether assembly comprises a tether head assembly, and wherein the tether head assembly is configured to be coupled to the interface feature on the IMD to navigate the distal section of the IMD to the wall tissue of the heart and to navigate the proximal section of the IMD into the blood vessel of the patient.

Description

Atly Ref. No. A0013329W001MEDICAL DEVICE IMPLANTATION SYSTEM

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 777,306, filed March 25, 2025, the entire content of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates to medical devices, and more particularly to implantable cardiac devices.BACKGROUND

[0003] Various types of implantable medical devices (IMDs) have been implanted for treating or monitoring one or more conditions of a patient. Such IMDs may be adapted to monitor or treat conditions or functions relating to heart, muscle, nerve, brain, stomach, endocrine organs or other organs and their related functions. Such HMDs may be associated with leads that position electrodes at a desired location or may be leadless with electrodes integrated with and / or attached to the device housing. These IMDs may have the ability to wirelessly transmit data either to another device implanted in the patient or to another instrument located externally of the patient, or both.

[0004] A cardiac device may include an HMD configured to deliver therapy signals to the heart to restore a more normal heart rhythm. Such IMDs sense the electrical activity of the heart, and deliver therapy signals based on the sensed electrical activity, via electrodes. Some IMDs are implanted with a distance from the heart and coupled to one or more leads that intravascularly extend into the heart to position electrodes with respect to cardiac tissue.SUMMARY

[0005] In general, this disclosure is directed to implantable medical devices (HMDs) configured to sense and deliver electrical signals to tissue of a patient via a plurality of electrodes. More particularly, this disclosure is directed to medical device systems configured to deliver and implant the HMD within vasculature of the patient.

[0006] In some examples, a single IMD is wholly implanted within vasculature of the patient. The IMD may define an elongated body within a distal section, a proximal section,Atty Ref. No. A0013329W001and a medial section connecting the distal and proximal sections. The distal section of the IMD may be disposed within one chamber of a heart of the patient and is able to sense signals from and / or deliver therapy signals (e.g., defibrillation signals, pacing signals) to wall tissue of the chamber. The proximal section may be disposed within another chamber of the heart and / or within a blood vessel connected to the heart. The proximal section may be able to sense signals from and / or deliver therapy signals to tissue around the proximal section. Each of the distal section or the proximal section may define a corresponding defibrillation electrode (e.g., a shock coil). The IMD may transmit a defibrillation signal between the defibrillation electrodes to defibrillate cardiac tissue of the patient.

[0007] The distal section and the proximal section may each define a rigid body configured to house electronic components (e.g., processing circuitry, signal generation circuitry, power source(s)) of the IMD. The medial section connecting the distal and proximal sections may be flexible, e.g., thereby allowing the distal and proximal sections to be implanted at different locations within the heart and / or the vasculature of the patient. The flexible medial portion may allow for movement of the IMD with the movement of the heart within the patient.

[0008] A medical device delivery system may be used to implant the IMD within the body of the patient. For example, the medical device delivery system may implant the distal section of the IMD within the one chamber of the heart and the proximal section of the IMD within another chamber of the heart and / or within a blood vessel. The medical device delivery system may implant all portions of the IMD within the respective target locations using a single assembly, e.g., without removing and / or inserting additional components into the body of the patient.

[0009] In some examples, the medical device delivery system includes one or more of an outer delivery catheter, an inner delivery catheter, and / or a tether assembly. The clinician may retain the IMD within the outer delivery catheter during navigation of the IMD to the heart of the patient. The clinician may retract the outer delivery catheter from around the IMD to implant the distal portion of the IMD within the chamber of the heart. The clinician may use the inner delivery catheter and / or the tether assembly to insert the proximal section of the IMD into the other chamber and / or the blood vessel. The medical device delivery system described herein may rotate sections of the IMD, e.g., within the vasculature and / or the heart of the patient. Portions of the medical delivery system (e.g.,Atty Ref. No. A0013329W001portions of the tether assembly) may be rotated and / or repositioned relative to the IMD (e.g., may be placed alongside a section of the IMD) to facilitate navigation of different portions of the IMD to different locations within the vasculature.

[0010] In some examples, this disclosure is directed to a medical device system comprising: an implantable medical device (IMD) comprising: a distal section comprising a fixation mechanism configured to affix the distal section to wall tissue within a chamber of a heart of the patient; a proximal section configured to be disposed within a blood vessel of the patient; a medial section connecting the distal section to the proximal section; and an interface feature disposed on one or more of the proximal section or the medial section; and an IMD delivery system comprising a tether assembly, wherein the tether assembly comprises a tether head assembly, and wherein the tether head assembly is configured to be coupled to the interface feature on the IMD to navigate the distal section of the IMD to the wall tissue of the heart and to navigate the proximal section of the IMD into the blood vessel of the patient.

[0011] In some examples, this disclosure is directed to a method comprising: advancing, via a tether assembly of a delivery system, a distal section of an implantable medical device (IMD) into a chamber of a heart of the patient, wherein the IMD comprises the distal section, a proximal section, and a medial section connecting the distal section to the proximal section, and wherein a tether head assembly of the tether assembly is coupled to an interface feature disposed on one or more of the proximal section or the medial section; affixing, via the tether assembly, a fixation mechanism on the distal section of the IMD to wall tissue within the chamber of the heart; advancing, via the tether assembly, the proximal section of the IMD into a blood vessel of the patient; and detaching, via the tether assembly, the tether head assembly from the interface feature to dispose the proximal section of the IMD within the blood vessel.Atty Ref. No. A0013329W001

[0012] In some examples, this disclosure is directed to an implantable medical device (IMD) delivery system comprising a delivery catheter defining an inner lumen, wherein the inner lumen is configured to retain an IMD; and a tether assembly extending through the inner lumen, the tether assembly comprising: a tether body; and a tether head assembly disposed on a distal end of the tether body, wherein the tether head assembly is configured to be removably coupled to a proximal section of the IMD, wherein the tether head assembly is configured to rotate the proximal section of the IMD relative to a distal section of the IMD to orient the proximal section of the IMD to a blood vessel of a patient, and wherein the tether head assembly is configured to advance into the blood vessel alongside the proximal section of the IMD to dispose the proximal section of the IMD in the blood vessel.

[0013] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the methods and systems described in detail within the accompanying drawings and description below.BRIEF DESCRIPTION OF DRAWINGS

[0014] The details of one or more examples of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of this disclosure will be apparent from the description and drawings, and from the claims.

[0015] FIG. l is a conceptual diagram illustrating an example device implanted in the heart of a patient, in accordance with one or more aspects of this disclosure.

[0016] FIG. 2 is a perspective diagram illustrating a side view of the example device of FIG. 1.

[0017] FIG. 3 is a cross-sectional diagram illustrating a partial cross-sectional view of a medical device delivery system.

[0018] FIG. 4 is a perspective diagram illustrating implantation of a distal section of the example device of FIG. 1 via the medical device delivery system of FIG. 3.

[0019] FIG. 5 is a perspective diagram illustrating exposure of a remainder of the example device of FIG. 1 via the medical device delivery system of FIG. 3.Atty Ref. No. A0013329W001

[0020] FIG. 6 is a perspective diagram illustrating repositioning of a proximal section of the example device of FIG. 1 via the medical device delivery system of FIG. 3.

[0021] FIG. 7 is a perspective diagram illustrating insertion of the proximal section of the example device of FIG. 1 into a blood vessel via the medical device delivery system of FIG. 3.

[0022] FIG. 8 is a perspective diagram illustrating implantation of the proximal section of the example device of FIG. 1 into the blood vessel via the medical device delivery system of FIG. 3.

[0023] FIG. 9 is a perspective diagram illustrating separation of the medical device delivery system of FIGS. 2-3 from the example device of FIG. 1.DETAILED DESCRIPTION

[0024] In general, this disclosure is directed to implantable medical devices (IMDs) and IMD delivery systems. While the IMD described below is primarily described as being wholly implanted within the vasculature of the patient by an IMD delivery system, the IMD may be at least partially disposed within an epicardial region of the patient or may be implanted within another body lumen of the patient by the IMD delivery system.

[0025] FIG. 1 is a conceptual diagram illustrating an example device 104 (alternatively referred to herein as “IMD 104”) implanted in heart 102 of a patient, in accordance with one or more aspects of this disclosure. Device 104 may include a distal section 110 implanted within one chamber of heart 102, a proximal section 116 disposed within a blood vessel 120 of the patient, and a medial section 114 connecting distal section 110 to proximal section 116.

[0026] Distal section 110 may be implanted within heart 102 at target location 106 within heart 102. In the example illustrated in FIG. 1, distal section 110 is disposed within a right ventricle (RV) of heart 102 and target location 106 is located along septum 108 of heart 102. In some examples, distal section 110 may be disposed within another chamber of heart 102 (e.g., right atrium (RA), left atrium (LA), left ventricle (LV)) and target location 106 may be located at another position within heart 102. For example, target location 106 may be located at or around a Triangle of Koch within the RA, a Bundle of His, high septum, left bundle branch, left bundle branch area, or conduction system of the patient.Atty Ref. No. A0013329W001

[0027] Distal section 110 may be a rigid body, e.g., may define a rigid housing. At least some components of device 104 may be disposed within the rigid body of distal section 110. For example, one or more power sources of device 104 may be disposed within distal section 110. Distal section 110 may include one or more electrodes (e.g., defibrillation electrode(s) such as shock coil(s), an electrically active surface of distal section 110) disposed on, distal to, or proximal to distal section 110 (e.g., on medial section 114 but close to distal section 110). Distal section 110 may deliver cardiac pacing signals (e.g., brady pacing, VF induction pacing, post-shock pacing, and ATP, etc.) to heart 102 at or around target location 106 via electrode(s) on distal section 110.

[0028] Distal section 110 may include one or more fixation elements disposed at or around a distal end of a housing of distal section 110. The one or more fixation elements may engage with wall tissue of heart 102 at or around target location 106, e.g., to affix distal section 110 to the wall tissue. The one or more fixation elements may include, but are not limited to, fixation tine(s), fixation barb(s), fixation helix(ces), or the like. In some examples, distal section 110 is affixed to the wall tissue via passive fixation, e.g., via tines embedded in the ventricular trabeculae. In some examples, electrode(s) of distal section 110 are disposed on the one or more fixation elements and may be distal to the distal end of the housing of distal section 110.

[0029] In some examples, the one or more fixation elements may be formed from an absorbable material (e.g., an absorbable polymer, an absorbable metal such as Zinc or Magnesium). Once device 104 is disposed within the vasculature, the absorbable material may absorb body fluids of the patient, e.g., to increase fixation of device 104 within the vasculature.

[0030] Proximal section 116 may be disposed within a chamber of heart 102 or blood vessel 120 connected to heart 102. In some examples, where proximal section 116 is disposed within heart 102, proximal section 116A is placed in a different chamber of heart 102 than distal section 110A. Blood vessel 120 may include, but is not limited to, a superior vena cava (SVC), an inferior vena cava (IVC), pulmonary artery, or a coronary sinus of the patient.

[0031] Proximal section 116 may be a rigid body, e.g., may define a rigid housing. The housing of proximal section 116 may define similar or different dimensions than the housing of distal section 110. In some examples, as illustrated in FIG. 1, proximal sectionAtly Ref. No. A0013329W001116 includes one rigid body. In some examples, proximal section 116 includes two or more rigid bodies, e.g., connected by intermediate flexible portions. The two or more rigid bodies may extend along a curvature, e.g., such that proximal section 116 defines an overall curved configuration. In such examples, the curvature of proximal section 116 and / or medial section 114 may facilitate disposal of device 104 around curvatures in the vasculature.

[0032] At least some components of device 104 may be disposed within the rigid body of proximal section 116. For example, one or more power sources of device 104 may be disposed within proximal section 116. Proximal section 116 may include one or more electrodes and / or defibrillation electrodes (e.g., shock coil(s), an electrically active surface of proximal section 116) disposed on, distal to, or proximal to proximal section 116 (e.g., on medial section 114 but close to proximal section 116, on an extension extending proximally from a proximal end of proximal section 116). Proximal section 116 may be configured to deliver cardiac pacing signals to cardiac tissue of heart 102 and / or to wall tissue of blood vessel 120 at or proximal section 116, e.g., via electrode(s) on proximal section 116.

[0033] Proximal section 116 may include one or more fixation elements disposed on, along, proximal to, and / or distal to a housing of proximal section 116. The one or more fixation elements may engage with wall tissue of heart 102 and / or blood vessel 120 to maintain a position of proximal section 116 within a chamber of heart 102 and / or blood vessel 120. The one or more fixation elements may engage with tissue of the patient with or without penetrating the tissue. The one or more fixation elements may include, but are not limited to, fixation tine(s), fixation barb(s), fixation heli(ces), expandable stent(s), inflatable elements, or the like. In some examples, electrode(s) of proximal section 116 are disposed on the one or more fixation elements.

[0034] In some examples, proximal section 116 is a proximal -most portion of device 104. In some examples, device 104 includes one or more extensions extending proximally from a proximal end of proximal section 116. The one or more extensions may include, but are not limited to, electrode(s), leadlet(s), one or more flexible sections, one or more rigid sections, or the like. The one or more extensions may extend further into the vasculature and away from heart 102.Atty Ref. No. A0013329W001

[0035] In some examples, device 104 includes a first set of one or more power sources in distal section 110 and a second set of one or more power sources in proximal section 116. In such examples, each set of power source(s) may provide power to components of device 104 to perform different functions. For example, the first set of power source(s) in distal section 110 may provide power to components of device 104 within distal section 110, e.g., for sensing and / or delivery of electrical signals at or around target location 106. In some examples, the first and second sets of power source(s) may provide power to the components within the respective distal and proximal sections 110, 116, e.g., to transmit a defibrillation signal between distal and proximal sections 110, 116 and into the tissue of heart 102. One or more sets of power source(s) may include rechargeable power source(s). In some examples, the configuration of device 104 may define a charging loop for the rechargeable power source(s).

[0036] Medial section 114 may connect distal and proximal sections, 110, 116. At least a portion of medial section 114 may be flexible, e.g., to allow for flexure of device 104 in response to movement of heart 102 throughout a cardiac cycle. In some examples, as illustrated in FIG. 1, an entire length of medial section 114 from distal section 110 to proximal section 116 is flexible. In some examples, medial section 114 may include one or more rigid bodies. In such examples, rigid body may be connected at either end to an adjacent rigid body (e.g., another rigid body on medial section 114, to distal section 110, to proximal section 116) via a flexible section.

[0037] Medial section 114 may define one or more inner lumens connecting an inner volume of distal section 110 to an inner volume of proximal section 116. The components of device 104 within the inner volumes of distal and proximal sections 110, 116, may be electrically connected via electrical conductor(s) extending through the inner lumen of medial section 114. In some examples medial section 114 includes a support element disposed within and extending through the inner lumen of medial section 114. The support element may control an amount of flexure of medial section 114 and / or inhibit excessive flexure of medial section 114. Electrode(s) and / or sensor(s) may be disposed on or within medial section 114. In some examples, as illustrated in FIG. 1, where an intermediate chamber of heart 102 (e.g., RA of heart 102) separates distal section 110 and proximal section 116, the electrode(s) and / or sensor(s) of medial section 114 may be disposed within the intermediate chamber.Atly Ref. No. A0013329W001

[0038] The electrode(s) and / or sensor(s) on one or more of distal section 110, medial section 114, or proximal section 116 may sense signals from the patient and transmit the signals to processing circuitry of device 104 (e.g., disposed within distal section 110 and / or proximal section 116). The processing circuitry may determine whether to deliver a therapy signal to heart 102 and / or a type of therapy signal to deliver to heart 102 based at last in part on the sensed signals from the electrode(s) and / or sensor(s) on or within distal section 110, medial section 114, and / or proximal section 116.

[0039] In some examples, sensor(s) on medial section 114 may sense electrical activity within a chamber of heart 102 (e.g., atrial electrical activity of heart 102). The processing circuitry of device 104 may determine, based on the sensed electrical activity, an electrogram (EGM) of the chamber of heart 102 (e.g., an atrial EGM). The processing circuitry may perform supraventricular tachycardiac (SVT) discrimination (e.g., dualchamber sensing) based at least in part on the determined EGM. In some examples, sensor(s) 114 sense mechanical or acoustic signals from heart 102. The processing circuitry may supplement the determined EGMs with the sensed mechanical and / or acoustic signals to monitor electrical stability of one or more chambers of heart 102 and / or hemodynamic status of heart 102.

[0040] The processing circuitry of device 104 may cause signal generation circuitry of device 104 to transmit a defibrillation shock signal (e.g., a defibrillation shock pulse) between the defibrillation electrodes on distal and proximal sections 110, 116. The defibrillation shock signal may travel from a first defibrillation electrode at or around distal section 110 to a second defibrillation electrode at or around proximal section 116, or vice versa. The defibrillation shock signal may travel through cardiac tissue of heart 10 between the first and second defibrillation electrodes, thereby shocking the cardiac tissue.

[0041] FIG. 2 is a perspective diagram illustrating a side view of example device 104 of FIG. 1. Device 104 may define an elongated body extending along longitudinal axis 201 from a proximal end 204A to a distal end 210B. The elongated body may include distal section 110, medial section 114, and proximal section 116. Distal section 110 may define distal end 210B and proximal section 116A may define proximal end 204A.

[0042] Distal section 110, medial section 114, and proximal section 116 may define same, similar, or different dimensions. For example, distal section 110 may define a greater or same diameter as proximal section 116. Proximal section 116 may define a sameAtly Ref. No. A0013329W001or greater length along longitudinal axis 201 as distal section 110. Medial section 114 may define a length longer than one or more of distal section 110 or proximal section 116.

[0043] Distal section 110 may define a housing 208, distal electrode 112, tine(s) 214, and reference electrode 212. Housing 208 may extend along longitudinal axis 201 from proximal end 210A to distal end 210B. Distal end 210B of housing 208 may be a same distal end of device 104.

[0044] Housing 208 may define a rigid body. Housing 208 may define a hermetically sealed cavity configured to contain at least some electronic components of device 104. Housing 208 may be formed from a conductive material including titanium or titanium alloy, stainless steel, MP35N (a non-magnetic nickel-cobalt-chromium-molybdenum alloy), platinum alloy or other bio-compatible metal or metal alloy, or other suitable conductive material. In some examples, housing 208 is formed from a non-conductive material including ceramic, glass, sapphire, silicone, polyurethane, epoxy, acetyl copolymer plastics, polyether ether ketone (PEEK), a liquid crystal polymer, other biocompatible polymer, or other suitable non-conductive material.

[0045] Housing 208 may extend distally from one end of medial section 114 (e.g., at proximal end 210A) to distal end 210B. Housing 202 may be cylindrical or substantially cylindrical, but may be other shapes, e.g., prismatic or other geometric shapes. An end of housing 202 at or around distal end 204 may define a flat surface (e.g., orthogonal to longitudinal axis 201), a domed surface, an angled surface, or any other shaped surfaces. Distal electrode 112 and tine(s) 214 may be disposed on housing 208 at or around distal end 210B and may extend distally and / or radially away from distal end 210B.

[0046] Tine(s) 214 may be formed from a shape memory material including, but not limited to, Nitinol. Tine(s) 214 may transition between a constrained configuration and an unconstrained configuration (e.g., as illustrated in FIG. 2). In the unconstrained configuration, tine(s) 214 may extend radially away from longitudinal axis 201 and curve back towards proximal end 210A. Each of tine(s) 214 may terminate in a distal tip configured to penetrate tissue of the patient. When tine(s) 214 are unconstrained, tine(s) 214 may transition from the constrained configuration to the unconstrained configuration. During the transition, tine(s) 214 may penetrate cardiac tissue of heart 102 (e.g., at or around target location 106) and affix distal section 110 to the cardiac tissue. Distal section 110 may include one or more fixation features on housing 202 at or around distal endAty Ref. No. A0013329W001210B in addition to or instead of tine(s) 214, e.g., to affix distal section 110 to the cardiac tissue. The one or more fixation features may include, but is not limited to, prongs, barbs, surface textures, recesses, protrusions, resorbable materials, or the like.

[0047] When distal section 110 is affixed to the cardiac tissue, distal electrode 112 may be placed in contact with a surface of the cardiac tissue. Distal electrode 112 may be a button electrode, a spring electrode, or the like. Distal electrode 112 may define an electrically active region and may be configured to transmit electrical signals (e.g., cardiac pacing signal) to and / or receive electrical signals from the cardiac tissue in contact with distal electrode 112 via the electrically active region. Distal electrode 112 may be formed from an electrically conductive material, such as titanium, platinum, iridium, tantalum, stainless steel, or alloys thereof. For example, distal electrode 112 may be formed from one or more of Platinum Iridium, a Platinum Iridium-clad alloy (e.g., Platinum Iridium-clad Titanium or Nitinol), Nitinol, or Tantalum Tungsten. In some examples, at least a portion of distal electrode 112 may be coated within an electrically insulating coating, e.g., a parylene, polyurethane, silicone, epoxy, or other insulating coating, to limit an electrically conductive active surface area of distal electrode 112 and define the electrically active region.

[0048] All, substantially all, or a portion of housing 208 may function as reference electrode 212. Reference electrode 212 may function as an anode electrode during pacing and / or sensing, e.g., while distal electrode 112 functions as the cathode electrode.Electrode 212 can fully or partially circumscribe housing 208, e.g., at or around proximal end 210A of housing 208. FIG. 2 shows electrode 212 extending as a singular band around the outer perimeter of housing 208. Electrode 212 can also include multiple segments spaced a distance apart along longitudinal axis 201 and / or around a perimeter of housing 208.

[0049] When housing 208 is formed from a conductive material, portions of housing 208 may be electrically insulated by a non-conductive material such as a coating of parylene, polyurethane, silicone, epoxy or other biocompatible polymer, or other suitable material. For the portions of housing 208 insulated by the non-conductive material, one or more discrete areas of housing 208 with conductive material can be exposed to define electrode 212.Atty Ref. No. A0013329W001

[0050] Proximal section 116 may define a housing 202 extending proximally along longitudinal axis 201 from proximal end 204A to distal end 204B. Proximal end 204A of housing 202 may be the proximal end of device 104. Proximal section 116 may include interface feature 206 extending proximally from proximal end 204A.

[0051] Housing 202 may define a rigid body. Housing 202 may define a hermetically sealed cavity configured to contain at least some electronic components of device 104. Together, housings 202, 208 and medial section 114 may contain all of the electronic components of device 104. Housing 202 may be formed from a conductive material including titanium or titanium alloy, stainless steel, MP35N (a non-magnetic nickel -cobalt-chromium-molybdenum alloy), platinum alloy or other bio-compatible metal or metal alloy, or other suitable conductive material. In some examples, housing 202 is formed from a non-conductive material including ceramic, glass, sapphire, silicone, polyurethane, epoxy, acetyl co-polymer plastics, polyether ether ketone (PEEK), a liquid crystal polymer, other biocompatible polymer, or other suitable non-conductive material. Housing 202 may extend proximally along longitudinal axis 201 from a proximal end of medial section 114 (e.g., at or around distal end 204B) to proximal end 204A. Housing 202 may be cylindrical or substantially cylindrical, but may be other shapes, e.g., prismatic or other geometric shapes. Housing 202 may define same, similar, or different dimensions than housing 208 of distal section 110.

[0052] Tine(s) 220 may be disposed on housing 202 and may be configured to transition from a constrained configuration and an unconstrained configuration. In the constrained configuration (e.g., when tine(s) 220 are constrained by an outer delivery catheter of an IMD delivery system), tine(s) 220 may be collapsed against the outer surface of housing 202, e.g., to reduce an overall profile of proximal section 116. When unconstrained, tine(s) 220 may expand radially away from housing 202 to the unconstrained configuration and secure proximal section 116 within blood vessel 120. Tine(s) 220 may be configured to penetrate a vessel wall of blood vessel 120 to secure proximal section 116 within blood vessel 120. In some examples, tine(s) 220 act against the vessel wall of blood vessel 120 without penetrating the vessel wall to secure proximal section 116 within blood vessel 120. Tine(s) 220 may be formed from a shape memory material including, but is not limited to, Nitinol. In some examples, tine(s) 220 are formed from silicone, polyurethane, or another biocompatible material.Atty Ref. No. A0013329W001

[0053] Tine(s) 220 may define electrically active surfaces and may transmit and / or sense electrical signals from the wall tissue of blood vessel 120. In some examples, as illustrated in FIG. 2, tine(s) 220 may be coupled to one or more bands 222A, 222B (collectively referred to herein as “bands 222”). Each of bands 222 may extend at least partially or entirely around an outer perimeter of housing 202. As illustrated in FIG. 2, one of bands 222 (e.g., first band 222A) may be positioned at or around distal end 204B of housing 202 and another of bands 222 (e.g., second band 222B) may be positioned at or around proximal end 204A of housing 202. One or more tines 220 may extend radially outwards from each of bands 222. Tine(s) 220 may be integral to bands 222 (e.g., may be formed from a same piece of material as bands 222). Each band 222 may be permanently or removably affixed to housing 202. For example, each band 222 may be disposed within a corresponding groove extending around the outer perimeter of housing 202.

[0054] Tine(s) 220 may be oriented to extend radially outwards from housing 202 and distally (e.g., towards distal end 210B of device 104). When proximal section 116 is disposed within blood vessel 120, the direction of tine(s) 220 may cause tine(s) 220 to act against a flow of blood within blood vessel 120 (e.g., flowing distally along longitudinal axis 201), e.g., thereby securing proximal section 116 within blood vessel 120. In some examples, one or more tine(s) 220 may extend distally and one or more other tine(s) 220 may extend proximally (e.g., towards proximal end 204A of device 104). In such examples, tine(s) 220 may inhibit unintended movement of proximal section 116 in either the proximal or the distal direction along longitudinal axis 201.

[0055] In some examples, instead of or in addition to tine(s) 220, proximal section 116 may include one or more additional fixation features including, but are not limited to, fixation barbs, expandable fixation elements, fixation helices (e.g., a side helix extending around an outer surface of housing 210), resorbable materials or the like.

[0056] All, substantially all, or a portion of housing 202 may function as reference electrode 224. Reference electrode 224 may function as an anode electrode during pacing and / or sensing, e.g., while distal electrode 112 and / or a portion of housing 202 functions as the cathode electrode. Electrode 224 can fully or partially circumscribe housing 202, e.g., at or around proximal end 204A of housing 202. FIG. 2 shows electrode 224 extending as a singular band around the outer perimeter of housing 202. Electrode 224 canAtty Ref. No. A0013329W001also include multiple segments spaced a distance apart along longitudinal axis 201 and / or around a perimeter of housing 202.

[0057] When housing 202 is formed from a conductive material, portions of housing 202 may be electrically insulated by a non-conductive material such as a coating of parylene, polyurethane, silicone, epoxy or other biocompatible polymer, or other suitable material. For the portions of housing 202 insulated by the non-conductive material, one or more discrete areas of housing 202 with conductive material can be exposed to define an electrode (e.g., electrode 224).

[0058] Interface feature 206 may engage with a tether assembly of an IMD delivery system operated by the clinician. Interface feature 206 may be disposed on proximal section 116 (e.g., at or around proximal end 204A, at or around distal end 204B) and / or on medial section 114. In some examples, as illustrated in FIG. 2, interface feature 206 extends proximally from proximal end 204A. Interface feature 206 may define a loop, a protrusion, or other interfaceable feature. Interface feature 206 may be formed from an electrically active or electrically insulated material. In some examples, interface feature 206 is formed from an electrically active material and is at least partially coated with an insulating material. In some examples, interface feature 206 may be at least partially covered by a resorbable material and may facilitate fixation of device 104 within patient 102 (e.g., in addition to tine(s) 214 and / or tine(s) 220).

[0059] Interface feature 206 may be flexible and may elastically flex away from longitudinal axis 201. The clinician may navigate device 104 within the vasculature of the patient by applying forces (e.g., pushing, pulling, rotary forces) on interface feature 206 via the tether assembly. The clinician may push on device 104 via the tether assembly to advance distal section 110 to target location 106 within heart 102. Once distal section 110 is affixed at target location 106 (e.g., via tine(s) 214), the clinician may pull proximal section 116 of device 104 into blood vessel 120 via interface feature 206. For example, the clinician may position a tether head assembly of tether assembly alongside proximal section 116 and pull proximal section 116 into blood vessel 120 by pulling on interface feature 206 using the tether head assembly. The flexibility of interface feature 206 may allow for repositioning of the tether head assembly relative to proximal portion 116 and / or repositioning of proximal portion 116 within heart 102 and / or the vasculature withoutAtly Ref. No. A0013329W001separating device 104 from the tether assembly, e.g., thereby simplifying the implantation process.

[0060] Medial section 114 may connect distal section 110 to proximal section 116. Medial section 114 may be flexible and may be configured to flex away from longitudinal axis 201. An inner lumen of medial section 114 may connect an inner volume of housing 202 to an inner volume of housing 208. Medial section 114 may include one or more rigid bodies (not pictured in FIG. 2) disposed along the length of medial section 114. In some examples, medial section 114 includes one or more electrodes disposed around an outer surface of medial section 114. The electrode(s) may sense electrical signals, e.g., within a chamber (e.g., atrium) of heart 102 between target location 106 and blood vessel 120.

[0061] Medial section 114 may include one or more conductors disposed within the inner lumen and electrically connecting the components disposed within housing 202 and housing 208. The one or more conductors may be configured to flex with medial section 114 and assume a plurality of different shapes. The one or more conductors may include, but are not limited to, a metallic alloy (e.g., a Tantalum alloy) capacitor, a polymer capacitor, or a diamond capacitor (a chemical vapor deposition (CVD) diamond).

[0062] In some examples, one or more of distal section 110, medial section 114, or proximal section 116 may include one or more power-generation elements. The one or more power-generation elements may include self-powering elements, energy harvesting systems, or the like. In some examples, the one or more power-generation elements include a fl exoelectric material and may generate electrical power for device 104 based on flexure of the flexoelectric material, e.g., as a result of movement of heart 102 during a cardiac cycle. The electrical power generated by the one or more power-generation elements may at least supply electrical power to device 104, e.g., for the sensing of signals from heart 102, for delivery of therapy signals (e.g., pacing signals, defibrillation shock signals to heart 102. The electrical power generated by the one or more power-generation elements may increase an overall lifespan of device 104. In some examples, when device 104 is deployed within the vasculature of the patient, device 104 may define a charging loop to recharge the one or more power-generation elements. In such examples, device 104 may recharge the one or more power-generation coils via a charging coil placed on or within the body of the patient and oriented to device 104.Atly Ref. No. A0013329W001

[0063] FIG. 3 is a cross-sectional diagram illustrating a partial cross-sectional view of medical device delivery system 300 (alternatively referred to herein as “IMD delivery system 300” or “system 300”). System 300 may include outer delivery catheter 302, inner delivery catheter 306, and tether assembly 310. Tether assembly 310 may include a tether handle assembly (not pictured in FIG. 3), tether body 311, and tether head assembly 312. The partial cross-section illustrated in FIG. 3 is of outer delivery catheter 302 and inner delivery catheter 308 and is taken along a reference plane extending along longitudinal axis 301 of system 300.

[0064] Outer delivery catheter 302 may extend along longitudinal axis 302 and may define an inner lumen 304. Outer delivery catheter 302 may define distal opening 305 to inner lumen 304 at or around a distal end of outer delivery catheter 302. Outer delivery catheter 302 may be formed from biocompatible polymers including, but is not limited to, Polyether block amide (e.g., Pebax®), Polyethylene, Ethylene Tetrafluoroethylene (ETFE), Polyethylene Terephthalate (PET), or Thermoplastic polyester elastomer(s) (TPC(s)). In some examples, metallic strand(s) and / or metallic wire braid(s) may be incorporated into the body of outer delivery catheter 302 (e.g., to improve pushability and / or flexibility of outer delivery catheter 302). In some examples, outer delivery catheter 302 is cut (e.g., is laser cut) from a metallic or polymer tubing. In such examples, outer delivery catheter 302 may be cut by a manufacturing assembly to control torque response, pushability, flexibility, and / or steerability of outer delivery catheter 302 along one or more sections of outer delivery catheter 302. In such examples, the tubing may be lined with a biocompatible polymer including, but is not limited to, Polytetrafluoroethylene (PTFE), Poly ether block amide, ETFE, TPC(s), or the like. Outer delivery catheter 302 may include one or more additives (e.g., Siloxane) to increase lubricity of outer delivery catheter 302.

[0065] Inner lumen 304 may be sized to retain device 104. For example, an inner diameter of inner lumen 304 may be greater than or equal to a maximum width of device 104 in a constrained configuration (e.g., with tine(s) 214, 220 in the respective constrained configurations). In some examples, inner lumen 304 defines a consistent inner diameter along an entire length of outer delivery catheter 302. In some examples, inner lumen 304 defines a tapered, stepped, or otherwise reduced diameter along a longitudinal length of outer delivery catheter 302 (e.g., to inhibit overtravel of device 104 proximally throughAtty Ref. No. A0013329W001inner lumen 304. In such examples, at least a distalmost portion of inner lumen 304 is sized to retain device 104. In such examples, a longitudinal length of the distalmost portion of inner lumen 304 is greater than or equal to a maximum length of device 104 in the collapsed configuration.

[0066] When device 104 is disposed within inner lumen 304 of outer delivery catheter 302, outer delivery catheter 302 may retain components of device 104 (e.g., tine(s) 214, 220) in the collapsed configurations. Tether head assembly 312 of tether assembly 310 may be removably coupled to fixation element 206 on device 104. The clinician may retain device 104 within inner lumen 304 by apply a proximal force on device 104 via tether assembly 310, e.g., to pull device 104 into inner lumen 304. In some examples, the clinician may individually actuate outer delivery catheter 302 (e.g., advance and / or retract outer delivery catheter 302 along longitudinal axis 301, bend outer delivery catheter 302 away from longitudinal axis 301) independent of inner delivery catheter 306 and / or tether assembly 310.

[0067] Inner delivery catheter 306 may extend along longitudinal axis 302 and may define an inner lumen 308. Inner delivery catheter 304 may define distal opening 309 to inner lumen 308 at or around a distal end of inner delivery catheter 304. Inner delivery catheter 306 may be disposed within inner lumen 304 of outer delivery catheter 302.

[0068] Inner lumen 308 may be sized to retain at least a portion of tether assembly 310. In some examples, as illustrated in FIG. 3, inner lumen 308 may be sized to retain both tether body 311 and tether head assembly 312. In some examples, only tether body 311 is retained in inner lumen 308. In some examples, only tether body 311 and a portion of tether head assembly 312 is disposed within inner lumen 308. Inner delivery catheter 304 may increase pushability of tether assembly 310. In such examples, a distal end of inner delivery catheter 304 may act on tether assembly 310 (e.g., on proximal portion 314 of tether head assembly 312) and facilitate insertion of proximal section 116 of device 104 into blood vessel 120. Inner delivery catheter 304 may be actuatable independent of outer delivery catheter 302 and / or tether assembly 310.

[0069] Tether assembly 310 may include the tether handle assembly (not pictured), tether head assembly 312, and tether body 311 connecting the tether handle assembly to tether head assembly 312. Tether body 311 may be pushable along longitudinal axis 301 and may at least partially flex away from longitudinal axis 301, e.g., in response toAtty Ref. No. A0013329W001actuation of one or more push and / or pull wires within tether body 311 by the clinician. Tether body 311 may be disposed within inner lumen 308 of inner delivery catheter 306. Tether body 311 may advanced distally out of inner lumen 308 of inner delivery catheter 306 and / or retracted proximally into inner lumen 308 of inner delivery catheter 306.

[0070] Tether head assembly 312 may be affixed to a distal end of tether body 311. In some examples tether head assembly 312 may be identical to or substantially similar to the device disclosed in commonly-assigned U.S. Patent No. 11,331,475. Tether head assembly 312 may include a proximal portion 314 and a distal portion 316. Proximal portion 314 may define a greater outer diameter than distal portion 312. Proximal portion 314 may be configured to interface with the distal end of inner delivery catheter 306, e.g., for transference of pushing forces from inner delivery catheter 306 into tether head assembly 312.

[0071] Distal portion 316 may define receptacle 318 at or around a distal end of distal portion 316. Receptacle 318 may be sized to retain at least a portion of interface feature 206 of device 104. When interface feature 206 enters receptacle 318, an inner element within distal portion 316 (not pictured in FIG. 3) may be advanced (e.g., by the clinician via a push and / or pull wire in tether body 311) to at least partially obstruct a distal opening of receptacle 318. Once the distal opening of receptacle 318 is obstructed, interface feature 206 may not exit receptacle 318 and may be retained by distal portion 316. The clinician may retract the inner element to re-open the distal opening and allow interface feature 206 to exit receptacle 318.

[0072] When interface feature 206 is retained within receptacle 318, interface feature 206 may rotate about one or more reference axes within receptacle 318. For example, interface feature 206 may rotate about a reference axis extending along longitudinal axis 301. Allowing interface feature 206 to rotate may allow tether head assembly 312 to be placed at a plurality of different positions relative to device 104. For example, tether head assembly 312 may be positioned in-line with device 104 (e.g., tether head assembly 312 being longitudinally aligned with proximal section 116 along longitudinal axis 201), e.g., within inner lumen 304 of outer delivery catheter 302. Tether head assembly 312 may be moved from the in-line position to be positioned alongside proximal section 116 of device 104 (e.g., tether head assembly 312 being positioned next to proximal section 116, withAtty Ref. No. A0013329W001distal portion 316 extending in a same direction as proximal end 204A of device 104), e.g., when the clinician advances proximal section 116 into blood vessel 120.

[0073] FIG. 4 is a perspective diagram illustrating implantation of distal section 110 of device 104 of FIG. 1 via system 300 of FIG. 3. The clinician may insert device 104 into inner lumen 304 of outer delivery catheter 302. Tether assembly 310 may be coupled to interface feature 206 on device 104 and may control the longitudinal movement of device 104 within outer delivery catheter 302. The clinician may insert proximal section 116 of device 104 into inner lumen 304 first and distal section 110 of device 104 into inner lumen 304 last, e.g., such that distal section 110 is closer to distal opening 305 of outer delivery catheter 302 than proximal section 116. When device 104 is disposed within inner lumen 304, outer delivery catheter 302 may maintain tine(s) (e.g., tine(s) 214, 220) and / or other fixation mechanisms on distal section 110, medial section 114, and / or proximal section 116 of device 104 in the constrained configuration. When device 104 is retained within inner lumen 304, tether head assembly 312 of tether assembly 310 may be in-line with proximal section 116 of device 104 (e.g., may be radially and circumferentially overlapping with proximal section 116 and longitudinally proximal to proximal section 116).

[0074] The clinician may insert outer delivery catheter 302 containing device 104 into heart 102 (e.g., into a chamber of heart 102). During navigation of outer delivery catheter 302 into heart 102, the entirety of device 104 may be retained within inner lumen 304, e.g., to inhibit unintended penetration of a blood vessel of the patient by tine(s) 214 on distal section 110 of device 104. During navigation, the clinician may apply a proximal force on device 104 via tether assembly 310 to retain device 104 within inner lumen 304. Outer delivery catheter 302 may flex and / or bend within the vasculature of the patient to navigate around bends in the vasculature. Medial portion 114 of device 104 may flex and / or bend accordingly with outer delivery catheter 302 to navigate around the bends.

[0075] The clinician may position distal opening 305 of outer delivery catheter 302 at or around target location 106 in heart 102. Once the clinician determines that distal opening 305 is at or around target location 106 (e.g., via one or more imaging techniques such as, but is not limited to, fluoroscopy), the clinician may advance at least a portion of distal section 110 out of outer delivery catheter 302 via distal opening 305. In some examples, the clinician pushes on device 104 via tether assembly 310 to advance distalAtty Ref. No. A0013329W001section 110 out of distal opening 305. In some examples, the clinician retracts outer delivery catheter 302 proximally while distally advancing distal section 110 or maintaining distal section 110 in a stationary position to expose distal section 110.

[0076] Once distal section 110 is at least partially exposed, tine(s) 214 and / or other fixation mechanisms may engage (e.g., puncture) cardiac tissue at or around target location 106 to affix distal section 110 to target location 106. In some examples, tine(s) 214, when unconstrained by outer delivery catheter 302, self-expand towards an expanded or unconstrained configuration and penetrate cardiac tissue at or around target location 106. When distal section 110 is affixed to target location 106, distal electrode 112 may be placed in contact within cardiac tissue at or around target location 106 and may sense signals from and / or deliver stimulation signals (e.g., pacing signals, shock signals) to the cardiac tissue.

[0077] FIG. 5 is a perspective diagram illustrating exposure of a remainder of device 104 of FIG. 1 via system 300 of FIG. 3. Once the clinician determines that distal section 110 is affixed to cardiac tissue of heart 102 at or around target location 106, the clinician may expose a remainder of device 104 within heart 102. The clinician may retract outer delivery catheter 302 proximally while maintaining a position of device 104 (e.g., via inner delivery catheter 306 and / or tether assembly 310) to expose device 104. Tether head assembly 312 of tether assembly 310 may be affixed to interface element 206 on one or more of medial section 114 or proximal section 116. In some examples, when device 104 is exposed, tether assembly 310 (e.g., tether body 311 and / or tether head assembly 312) may retain fixation feature(s) on medial section 114 and / or proximal section 116 (e.g., tine(s) 220) in the constrained configuration. In some examples, when device 104 is exposed, the fixation feature(s) at least partially transition from the constrained configuration towards an expanded or unconstrained configuration.

[0078] FIG. 6 is a perspective diagram illustrating repositioning of proximal section 116 of device 104 of FIG. 1 via system 300 of FIGS. 2-3. The clinician may reposition proximal section 116 of device 104 (e.g., within a chamber of heart 102) to orient proximal end 204A of proximal section 116 towards blood vessel 120. The clinician may apply a pushing and / or a rotary force via inner delivery catheter 306 and / or tether assembly 310 on proximal section 116 to rotate proximal section 116 within heart 102. In some examples, as illustrated in FIG. 6, the clinician may further advance at least a portionAtty Ref. No. A0013329W001of tether assembly 310 out of distal opening 309 of inner delivery catheter 306 to further apply forces on proximal section 116.

[0079] Medial section 114 may be flexible and may facilitate the rotation of proximal section 116 without altering the position of distal section 110 within heart 102. Interface feature 206 on device 104 may be flexible and may facilitate the re-positioning and / or reorienting of tether assembly 310 relative to proximal section 116 as the clinician rotates proximal section 116. The clinician may monitor the position of proximal section 116 within heart 102 via one or more imaging techniques and may continue to re-position proximal section 116 until proximal end 204A is oriented towards and / or is within an opening of blood vessel 120. Blood vessel 120 may include, but is not limited to, a superior vena cava (SVC) of the patient, an inferior vena cava (IVC) of the patient, a pulmonary artery of the patient, or a coronary sinus of the patient.

[0080] FIG. 7 is a perspective diagram illustrating insertion of proximal section 116 of device 104 of FIG. 1 into blood vessel 120 via system 300 of FIG. 3. FIG. 8 is a perspective diagram illustrating implantation of proximal section 116 of the example device of FIG. 1 into the blood vessel via the medical device delivery system of FIGS. 2-3.

[0081] The clinician may position tether head assembly 312 to be next to proximal portion 116 (e.g., longitudinally overlapping with proximal portion 116 and extending in a same or parallel direction as proximal end 204A of proximal portion 116). The clinician may then advance tether head assembly 312 into blood vessel 120. Fixation feature 206 may be retained within receptacle 118 of tether head assembly 312. As tether head assembly 312 is advanced into blood vessel 120, tether head assembly 312 may pull proximal portion 116 into blood vessel 120.

[0082] In some examples, the clinician advances both inner delivery catheter 306 and tether head assembly 312 into blood vessel 120. In some examples, blood vessel 120 may not be sized to retain both inner delivery catheter 306 and proximal section 116. In such examples, the clinician may advance tether assembly 310 further out of inner delivery catheter 306 (e.g., via distal opening 309) and into blood vessel 120, e.g., as illustrated in FIG. 8. In such examples, only a portion of tether assembly 310 (e.g., tether head assembly 312 and a distal portion of tether body 311) and proximal section 116 may enter blood vessel 120.Atly Ref. No. A0013329W001

[0083] In some examples, fixation feature(s) on proximal section 116 (e.g., tine(s) 220) may be at least partially expanded or deployed when proximal section 116 is unconstrained by outer delivery catheter 302. Tine(s) 220 may be oriented to extend distally towards distal end 204B of proximal section 116. When the clinician advances proximal section 116 into blood vessel 120 via tether assembly 310, tine(s) 220 may not engage with the vessel wall of blood vessel 120 to impede progress of proximal section 116 into blood vessel 120, e.g., due to tine(s) 220 extending away from a direction of advance of proximal section 116. When proximal section 116 is within blood vessel 120, tine(s) 220 may engage with the vessel wall (e.g., due to the direction of blood flow in blood vessel 120) to affix proximal section 116 within blood vessel 120. In some examples, fixation feature(s) are constrained, e.g., by inner delivery catheter 304 and / or tether assembly 310. In such examples, the clinician may cause fixation features(s) to expand and / or deploy and engage with the vessel wall of blood vessel 120 when proximal section 116 is disposed within blood vessel 120 and / or when proximal section 116 is separated from tether assembly 310.

[0084] FIG. 9 is a perspective diagram illustrating separation of system 300 of FIG. 3 from device 104 of FIG. 1. The clinician may advance proximal section 116 into blood vessel 120 via tether assembly 310 until the clinician determines (e.g., via one or more imaging techniques) that proximal section 116 is at a target location within blood vessel 120. The clinician may then release tether assembly 310 from proximal section 116 and retract system 300 from within the patient, leaving device 104 within the vasculature of the patient.

[0085] The clinician may actuate one or more push or pull wires extending along the length of tether body 311 to cause tether head assembly 312 to release fixation feature 206. The clinician may actuate the push or pull wire(s) via the tether handle assembly coupled to tether body 311. When actuated, the push or pull wire(s) may open up a distal opening of receptacle 318, allowing fixation feature 206 to exit receptacle 318. Once fixation feature 206 exits receptacle 318, the clinician may retract tether assembly 310 from within blood vessel 120, leaving proximal section 116 implanted within blood vessel 120. Tine(s) 220 and / or other fixation features on proximal section 116 may engage with the vessel wall of blood vessel 120 to retain proximal section 116 within blood vessel 120.Atly Ref. No. A0013329W001

[0086] It be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0087] In addition, it should be noted that system described herein may not be limited to treatment of a human patient. In alternative examples, the system may be implemented in non-human patients, e.g., primates, canines, equines, pigs, and felines. These other animals may undergo clinical or research therapies that may benefit from the subject matter of this disclosure.

[0088] This disclosure describes each of the following examples.

[0089] Example 1: a medical device system comprising: an implantable medical device (IMD) comprising: a distal section comprising a fixation mechanism configured to affix the distal section to wall tissue within a chamber of a heart of the patient; a proximal section configured to be disposed within a blood vessel of the patient; a medial section connecting the distal section to the proximal section; and an interface feature disposed on one or more of the proximal section or the medial section; and an IMD delivery system comprising a tether assembly, wherein the tether assembly comprises a tether head assembly, and wherein the tether head assembly is configured to be coupled to the interface feature on the IMD to navigate the distal section of the IMD to the wall tissue of the heart and to navigate the proximal section of the IMD into the blood vessel of the patient.

[0090] Example 2: the medical device system of example 1, wherein the interface feature comprises a loop disposed on: a proximal end of the proximal section of the IMD; a distal end of the proximal section of the IMD; or the medical section of the IMD.

[0091] Example 3: the medical device system of any of examples 1-2, wherein the tether head assembly defines a receptacle configured to removably retain the interface feature of the IMD.

[0092] Example 4: the medical device system of any of examples 1-3, wherein the tether head assembly is configured to be oriented in-line with the proximal section of theAtly Ref. No. A0013329W001IMD during delivery of the distal section of the IMD into the chamber of the heart, and wherein the tether head assembly is configured to be positioned alongside the proximal section of the IMD during delivery of the proximal section of the IMD into the blood vessel.

[0093] Example 5: the medical device system of example 4, wherein when the tether head assembly is oriented in-line with the proximal section of the IMD, the tether head assembly extends distally along a reference axis parallel to a longitudinal axis of the IMD, and wherein when the tether head assembly is positioned alongside the proximal section of the IMD, the tether head assembly extends proximally along the reference axis.

[0094] Example 6: the medical device system of any of examples 1-5, wherein the interface feature comprises a flexible member configured to interface with the tether head assembly.

[0095] Example 7: the medical device system of any of examples 1-6, wherein when the tether head assembly interfaces with the interface feature, the tether head assembly is configured to allow free rotation of the interface feature relative to the tether head assembly about at least one reference plane.

[0096] Example 8: the medical device system of any of examples 1-7, wherein the IMD further comprises one or more fixation elements disposed on the proximal section, wherein the one or more fixation elements are configured to interface with a blood vessel wall of the blood vessel to secure the proximal section within the blood vessel.

[0097] Example 9: the medical device system of example 8, wherein the one or more fixation elements comprises: one or more fixation tines; one or more fixation barbs; or a resorbable material.

[0098] Example 10: the medical device system of any of examples 1-9, wherein when the tether head assembly interfaces with the interface feature of the IMD, the tether head assembly is configured to cause the proximal section of the IMD to rotate within vasculature of the patient in response to forces applied along the tether assembly.

[0099] Example 11 : the medical device system of any of examples 1-10, wherein the delivery system further comprises: an outer delivery catheter, the outer delivery catheter defining a first lumen configured to retain the IMD; and an inner delivery catheter configured to be disposed within the first lumen, the inner delivery catheter defining a second lumen configured to retain at least a portion of the tether assembly.Atly Ref. No. A0013329W001

[0100] Example 12: the medical device system of example 11, wherein the tether head assembly is configured to extend distally out of a distal end of inner delivery catheter.

[0101] Example 13: the medical device system of any of examples 11 and 12, wherein each of the inner delivery catheter and the outer delivery catheter is individually steerable.

[0102] Example 14: the medical device system of any of examples 1-13, wherein the chamber of the heart comprises a ventricle of the heart, and wherein the blood vessel comprises a Superior Vena Cava (SVC) or a pulmonary artery of the patient.

[0103] Example 15: a method comprising: advancing, via a tether assembly of a delivery system, a distal section of an implantable medical device (IMD) into a chamber of a heart of the patient, wherein the IMD comprises the distal section, a proximal section, and a medial section connecting the distal section to the proximal section, and wherein a tether head assembly of the tether assembly is coupled to an interface feature disposed on one or more of the proximal section or the medial section; affixing, via the tether assembly, a fixation mechanism on the distal section of the IMD to wall tissue within the chamber of the heart; advancing, via the tether assembly, the proximal section of the IMD into a blood vessel of the patient; and detaching, via the tether assembly, the tether head assembly from the interface feature to dispose the proximal section of the IMD within the blood vessel.

[0104] Example 16: the method of example 15, wherein the delivery system further comprises: an outer delivery catheter, the outer delivery catheter defining a first lumen configured to retain the IMD; and an inner delivery catheter configured to be disposed within the first lumen, the inner delivery catheter defining a second lumen configured to retain at least a portion of the tether assembly.

[0105] Example 17: the method of example 16, wherein advancing the distal section of the IMD into the chamber of the heart comprises advancing the outer delivery catheter containing the IMD into the chamber of the heart, and wherein affixing the fixation mechanism on the distal section to the wall tissue within the chamber of the heart comprises advancing, via the tether assembly, the fixation mechanism out of a distal end of the outer delivery catheter.

[0106] Example 18: the method of example 17, wherein the fixation mechanism is configured to self-expand to engage with the wall tissue when the fixation mechanism is advanced out of the outer delivery catheter.Atly Ref. No. A0013329W001

[0107] Example 19: the method of any of examples 16-18, wherein advancing the proximal section of the IMD into the blood vessel of the patient comprises: retracting the outer delivery catheter from around the IMD; rotating, via the tether assembly, the proximal section of the IMD within the heart to orient the tether head assembly and a proximal end of the proximal section of the IMD towards the blood vessel; and advancing, via the tether assembly, the tether head assembly and the proximal section of the IMD into the blood vessel.

[0108] Example 20: the method of example 19, wherein advancing the tether head assembly and the proximal section of the IMD into the blood vessel comprises: advancing the inner delivery catheter to a first position within the blood vessel; and advancing, via the tether assembly, the tether head assembly distally from a distal end of the inner delivery catheter to advance the tether head assembly and the proximal section of the blood vessel to a second position within the blood vessel, the second position being further away from the heart than the first position.

[0109] Example 21 : the method of any of examples 16-20, wherein detaching tether head assembly from the interface feature to dispose the proximal section of the IMD within the blood vessel comprises causing, by a tether handle assembly of the tether assembly, the tether head assembly to release the interface feature from within a receptacle in the tether head assembly.

[0110] Example 22: the method of any of examples 15-21, wherein the interface feature comprises a loop disposed on: a proximal end of the proximal section of the IMD; a distal end of the proximal section of the IMD; or the medical section of the IMD.

[0111] Example 23: the method of any of examples 15-22, wherein the interface feature comprises a flexible member configured to interface with the tether head assembly.

[0112] Example 24: the method of any of examples 15-23, wherein when the tether head assembly interfaces with the interface feature, the tether head assembly is configured to allow free rotation of the interface feature relative to the tether head assembly about at least one reference plane.

[0113] Example 25: the method of any of examples 15-24, wherein the IMD further comprises one or more fixation elements disposed on the proximal section, and wherein advancing the proximal section of the IMD into the blood vessel of the patient furtherAtly Ref. No. A0013329W001comprises: placing the one or more fixation elements in contact with a blood vessel wall of the blood vessel to secure the proximal section within the blood vessel.

[0114] Example 26: the method of examples 25, wherein the one or more fixation elements comprises: one or more fixation tines; one or more fixation barbs; or a resorbable material.

[0115] Example 27: the method of any of examples 15-26, wherein the chamber of the heart comprises a ventricle of the heart, and wherein the blood vessel comprises a Superior Vena Cava (SVC) or a pulmonary artery of the patient.

[0116] Example 28: an implantable medical device (IMD) delivery system comprising a delivery catheter defining an inner lumen, wherein the inner lumen is configured to retain an IMD; and a tether assembly extending through the inner lumen, the tether assembly comprising: a tether body; and a tether head assembly disposed on a distal end of the tether body, wherein the tether head assembly is configured to be removably coupled to a proximal section of the IMD, wherein the tether head assembly is configured to rotate the proximal section of the IMD relative to a distal section of the IMD to orient the proximal section of the IMD to a blood vessel of a patient, and wherein the tether head assembly is configured to advance into the blood vessel alongside the proximal section of the IMD to dispose the proximal section of the IMD in the blood vessel.

[0117] Example 29: the IMD delivery system of example 28, wherein the tether head assembly defines a receptacle configured to retain an interface feature on the proximal section of the IMD.

[0118] Example 30: the IMD delivery system of example 29, wherein the tether assembly is configured to allow for rotation of the interface feature about a reference axis within the receptacle.

[0119] Example 31 : the IMD delivery system of any of examples 28-30, wherein the tether head assembly is configured to be retracted into the inner lumen of the delivery catheter and advanced distally out of the inner lumen of the delivery catheter.

[0120] Example 32: the IMD delivery system of any of examples 28-31, wherein the tether head assembly is electrically active.

[0121] Example 33: the IMD delivery system of any of examples 28-32, wherein delivery catheter comprises an outer delivery catheter, wherein the inner lumen comprises a first lumen, and wherein the IMD delivery system further comprises: an inner deliveryAtly Ref. No. A0013329W001catheter disposed within the first lumen of the outer delivery catheter, wherein the inner deliver catheter defines a second lumen, and wherein the tether body of the tether assembly is configured to be at least partially disposed within the second lumen.

[0122] Example 34: the IMD delivery system of example 33, wherein each of the outer delivery catheter and the inner delivery catheter is individually steerable.

[0123] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Atly Ref. No. A0013329W001WHAT IS CLAIMED IS:

1. A medical device system comprising:an implantable medical device (IMD) comprising:a distal section comprising a fixation mechanism configured to affix the distal section to wall tissue within a chamber of a heart of the patient;a proximal section configured to be disposed within a blood vessel of the patient;a medial section connecting the distal section to the proximal section; andan interface feature disposed on one or more of the proximal section or the medial section; andan IMD delivery system comprising a tether assembly, wherein the tether assembly comprises a tether head assembly, and wherein the tether head assembly is configured to be coupled to the interface feature on the IMD to navigate the distal section of the IMD to the wall tissue of the heart and to navigate the proximal section of the IMD into the blood vessel of the patient.

2. The medical device system of claim 1, wherein the interface feature comprises a loop disposed on:a proximal end of the proximal section of the IMD;a distal end of the proximal section of the IMD; orthe medical section of the IMD.

3. The medical device system of any of claims 1-2, wherein the tether head assembly defines a receptacle configured to removably retain the interface feature of the IMD.

4. The medical device system of any of claims 1-3, wherein the tether head assembly is configured to be oriented in-line with the proximal section of the IMD during delivery of the distal section of the IMD into the chamber of the heart, and wherein the tether head assembly is configured to be positioned alongside the proximal section of the IMD during delivery of the proximal section of the IMD into the blood vessel.Atly Ref. No. A0013329W0015. The medical device system of claim 4, wherein when the tether head assembly is oriented in-line with the proximal section of the IMD, the tether head assembly extends distally along a reference axis parallel to a longitudinal axis of the IMD, and wherein when the tether head assembly is positioned alongside the proximal section of the IMD, the tether head assembly extends proximally along the reference axis.

6. The medical device system of any of claims 1-5, wherein the interface feature comprises a flexible member configured to interface with the tether head assembly.

7. The medical device system of any of claims 1-6, wherein when the tether head assembly interfaces with the interface feature, the tether head assembly is configured to allow free rotation of the interface feature relative to the tether head assembly about at least one reference plane.

8. The medical device system of any of claims 1-7, wherein the IMD further comprises one or more fixation elements disposed on the proximal section, wherein the one or more fixation elements are configured to interface with a blood vessel wall of the blood vessel to secure the proximal section within the blood vessel.

9. The medical device system of claim 8, wherein the one or more fixation elements comprises:one or more fixation tines;one or more fixation barbs; ora resorbable material.

10. The medical device system of any of claims 1-9, wherein when the tether head assembly interfaces with the interface feature of the IMD, the tether head assembly is configured to cause the proximal section of the IMD to rotate within vasculature of the patient in response to forces applied along the tether assembly.Atly Ref. No. A0013329W00111. The medical device system of any of claims 1-10, wherein the delivery system further comprises:an outer delivery catheter, the outer delivery catheter defining a first lumen configured to retain the IMD; andan inner delivery catheter configured to be disposed within the first lumen, the inner delivery catheter defining a second lumen configured to retain at least a portion of the tether assembly.

12. The medical device system of claim 11, wherein the tether head assembly is configured to extend distally out of a distal end of inner delivery catheter.

13. The medical device system of any of claims 11 and 12, wherein each of the inner delivery catheter and the outer delivery catheter is individually steerable.

14. The medical device system of any of claims 1-13, wherein the chamber of the heart comprises a ventricle of the heart, and wherein the blood vessel comprises a Superior Vena Cava (SVC) or a pulmonary artery of the patient.

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