Atty Ref. No: A0011315WO01 DELIVERY AND RETRIEVAL SYSTEM FOR A MEDICAL DEVICE [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No.63/620,012, filed January 11, 2024, the entire content of which is incorporated herein by reference. TECHNICAL FIELD [0002] This disclosure is related to systems for delivery and/or retrieval of implantable medical devices. BACKGROUND [0003] Various types of implantable medical devices have been implanted for treating or monitoring one or more conditions of a patient. Such implantable medical devices may be adapted to allow medical devices to monitor and/or treat conditions or functions relating to heart, muscle, nerve, brain, stomach, endocrine organs or other organs and their related functions. The implantable medical devices may be implanted at target locations selected to detect a physiological condition of the patient and/or deliver one or more therapies. For example, implantable medical devices may be delivered to locations within an atrium or ventricle of a heart to sense intrinsic cardiac signals and deliver pacing or antitachyarrhythmia shock therapy. [0004] Some implantable medical devices are sized to be completely implanted within one of the chambers of the heart and/or another anatomical volume of the patient to detect a physiological condition and/or deliver one or more therapies. Such implantable medical devices may utilize delivery and/or retrieval systems to allow a clinician to navigate the implantable medical device (e.g., through vasculature of the patient) to the target location, and/or to retrieve the implantable medical device from the patient. In some examples, the implantable medical device may include one or more anchoring components intended to engage tissues at the target location (e.g., for implantation) and/or disengage from tissue at the target location (e.g., for retrieval). SUMMARY [0005] The disclosure describes a medical system configured to deliver, position,
Atty Ref. No: A0011315WO01 retrieve, and/or otherwise re-orient an implantable medical device (“IMD”) within an anatomical volume (e.g., a chamber of a heart) within a patient. The medical system including a delivery tool supporting a device receptacle configured to hold the IMD within a receptacle volume. The delivery tool includes a shapeable portion configured to define and retain one or more curvatures in response to one or more bending forces imparted (e.g., by a clinician) to the shapeable portion. Hence, the delivery tool may be configured to allow a clinician to cause the delivery tool to define and retain one or more curves based on a transit path within a patient (e.g., within a heart of the patient) observed, visualized, and/or otherwise assessed by the clinician prior to delivery of the IMD using the delivery tool. [0006] In an example, a medical system comprises: a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device; and a delivery tool supporting the device receptacle, wherein the delivery tool includes a shapeable body configured to transition from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature when a first bending force acts on the shapeable body, wherein the shapeable body is configured to retain the second configuration when the first bending force ceases to act on the shapeable body, wherein the delivery tool defines a delivery lumen extending through the shapeable body and a delivery lumen opening which opens into the receptacle volume, and wherein the device receptacle and the shapeable body are configured to insert within one or more anatomical volumes of a patient. [0007] In an example, a medical system comprises: a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device, a receptacle opening which opens into the receptacle volume, and a receptacle axis extending from the delivery lumen opening to the receptacle opening; and a delivery tool supporting the device receptacle, wherein the delivery tool defines a delivery lumen and a delivery lumen opening which opens into the receptacle volume, wherein the delivery tool includes a shapeable body including a shapeable proximal portion and a shapeable distal portion, the delivery lumen extending from the shapeable proximal portion to the shapeable distal portion, the shapeable distal portion supporting the device receptacle, and the device receptacle and the shapeable body configured to insert within one or more anatomical volumes of a heart of a patient, wherein the shapeable body is configured to
Atty Ref. No: A0011315WO01 transition from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature when a first bending force acts on the shapeable body, wherein the shapeable body is configured to retain the second configuration when the first bending force ceases to act on the shapeable body, wherein the device receptacle defines a receptacle volume shape of a receptacle boundary bounding the receptacle volume, and wherein the device receptacle is a substantially rigid device configured to maintain the receptacle volume shape when the shapeable body transitions from the first configuration to the second configuration. [0008] In an example, a method comprises: supporting, using a delivery tool, a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device, wherein the delivery tool defines a delivery lumen and a delivery lumen opening which opens into the receptacle volume; transitioning, using a bending force acting on a shapeable body of the delivery tool, the shapeable body from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature, wherein the device receptacle and the shapeable body are configured to insert within one or more anatomical volumes of a patient; and retaining, using the shapeable body, the shapeable body is in the second configuration when the bending force ceases to act on the shapeable body. [0009] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS [0010] FIG.1 is a conceptual diagram illustrating an example medical system and device receptacle within a heart. [0011] FIG.2 is a conceptual diagram illustrating an example shapeable portion of a delivery tool and a heart. [0012] FIG.3 is a schematic plan view of a shapeable portion defining a first curvature. [0013] FIG.4 is a schematic plan view of the shapeable portion of FIG.3 defining a second curvature. [0014] FIG.5 is a schematic plan view of the shapeable portion of FIG.3 and FIG.4
Atty Ref. No: A0011315WO01 having transitioned from a third curvature to a fourth curvature. [0015] FIG.6 is a schematic end view of the shapeable portion of FIG.5 illustrating a first curve in a first plane-of-curvature and a second curve in a second plane-of -curvature. [0016] FIG.7 is a schematic illustration of a delivery tool defining a plurality of paths through a three-dimensional space. [0017] FIG.8 is a schematic plan view of a delivery tool defining a plurality of markings. [0018] FIG.9 is a schematic plan view of a delivery tool defining a plurality of zones. [0019] FIG.10 is a schematic cross-sectional view of a device receptacle holding an implantable medical device, with the cutting plane taken parallel to the page. [0020] FIG.11 illustrates an example technique for supporting a device receptacle using a delivery tool. DETAILED DESCRIPTION [0021] This disclosure describes a medical system including a delivery tool configured to deliver, position, and/or retrieve an implantable medical device (“IMD”) within an anatomical volume (e.g., a chamber of a heart) within a patient. The delivery tool supports a device receptacle configured to hold the IMD and a shapeable portion configured to define one or more curves. The shapeable portion is configured to define the one or more curves in response to a bending force imparted (e.g., by a clinician) on the shapeable portion. In some examples, the shapeable portion includes one or more elongate bodies configured to impart the bending force to the shapeable portion. For example, an elongate body may be configured to impart the bending force to the shapeable portion in response to a pushing or pulling force exerted on the elongate body (e.g., by a clinician). The shapeable portion is configured to retain the one or more curves in the absence of the bending force (e.g., when the clinician ceases to impart the bending force). Hence, the delivery tool may be configured to allow the clinician to cause the delivery tool to define and retain one or more curves based on a transit path within a patient (e.g., within a heart of the patient) observed, visualized, and/or otherwise assessed by the clinician prior to delivery of the IMD using the delivery tool. [0022] The definition and retention of one or more curves by the shapeable portion may assist in the delivery of the IMD over a transit path observed, visualized, and/or
Atty Ref. No: A0011315WO01 otherwise assessed by the clinician. For example, during an open-heart surgery, when the clinician may be able to directly observe the heart, the clinician may observe, visualize, and/or otherwise assess a transit path that may be desired as the delivery tool delivers the IMD to a target site within the heart. The clinician may observe, visualize, and/or otherwise assess, for example, a transit path through a right atrium of the heart, through a tricuspid valve of the heart, and into a right ventricle (RV) of the heart which may be desired to position the device receptacle and/or IMD in proximity to the target site. The delivery tool is configured to allow the clinician to manipulate the shapeable portion to define and retain one or more curves based on the transit path observed, visualized, and/or otherwise assessed to ease a delivery of the IMD through the heart to the target site. [0023] The shapeable body may extend from a proximal end (“shapeable body proximal end”) to a distal end (“shapeable body distal end”). The delivery tool defines a delivery lumen extending at least from the shapeable body proximal end to the shapeable body distal end and opening into the receptacle volume defined by the device receptacle. The medical system may include a delivery system configured to extend through the delivery lumen and engage with and/or disengage from the IMD when the IMD is positioned within the receptacle volume. The delivery system is configured to move within the delivery lumen and relative to the shapeable portion (e.g., to translate proximally, translate distally, and/or rotate) to cause motion of the IMD within the receptacle volume. [0024] The shapeable portion is configured to allow a clinician to cause bend and/or flex the shapeable portion to define a shape which may ease a transit of the device receptacle toward a target site and/or provide assistance in placing the device receptacle 108 in proximity to the target site. The shapeable portion is configured to define and retain a plurality of curves (e.g., through manipulation by the clinician) to cause the delivery tool to define a wide variety of paths through three-dimensional space. For example, a clinician may cause the shapeable portion to define a plurality of curves extending within different planes-of-curvature, such that the shapeable portion extends over a first range in the first spatial dimension, a second range in the second spatial dimension, and a third range over the third spatial dimension. Hence, the delivery tool is configured such that a clinician may manipulate the shapeable portion based on a specific transit path visualized, observed, and/or otherwise assessed by the clinician for a given patient. The delivery tool is configured to retain the one or more curves caused by the manipulations of the clinician
Atty Ref. No: A0011315WO01 during delivery of the IMD substantially over the specific transit path visualized for the given patient. Thus, the delivery tool is configured to allow a clinician to place the delivery tool in patient-specific configurations, based on the specific transit path visualized, observed, and/or otherwise assessed for the patient. [0025] FIG.1 is a conceptual diagram illustrating an example medical system 100 within a right atrium (“RA”) and right ventricle (RV) of a heart 101. Heart 101 is depicted as a cross-section, with the cutting plane parallel to the page. Medical system 100 is configured to deliver and/or retrieve an implantable medical device 102 (“IMD 102”) to and/or from the vicinity of a target site 104 of heart 101. Medical system 100 includes a delivery tool 106 supporting a device receptacle 108. Device receptacle 108 is configured to hold IMD 102 during delivery, deployment, and/or retrieval of IMD 102. Device receptacle 108 includes a wall 113 (“receptacle wall 113”) defining a receptacle volume 112 configured to hold and/or support IMD 102 during the delivery, deployment, and/or retrieval of IMD 102. In examples, IMD 102 includes an attachment member 132 configured to engage tissues within target site 104. In FIG.1, receptacle wall 113 is depicted as transparent, although this is not required. In examples, delivery of IMD 102 by medical system 100 can be performed with IMD 102 “preloaded” or present within device receptacle 108 during advancement of delivery catheter 106 to the anatomical volume. [0026] Device receptacle 108 (e.g., receptacle wall 113) may define a receptacle opening (e.g., receptacle opening 111 (FIG.10)) which opens into receptacle volume 112. Receptacle opening 111 may be, for example, at a distal end 110 of receptacle 108 (“receptacle distal end 110”). Although IMD 102 and attachment member 132 are depicted as extending distal to receptacle opening 111 in FIG.1 (e.g., as might occur during an implantation of IMD 102), receptacle volume 112 may be configured such that IMD 102 and/or attachment member 132 are proximal to receptacle opening 111 (e.g., as might be desired during delivery of IMD 102 to target site 104). [0027] In FIG.1, IMD 102 is illustrated as partially positioned within receptacle volume 112 and extending through receptacle opening 111. Receptacle opening 111 may be configured to allow at least IMD 102 to pass therethrough. For example, receptacle opening 111 may be configured to allow IMD 102 to pass in a distal direction D from a position within receptacle volume 112 to a position distal to receptacle distal end 110. Receptacle opening 111 may be configured to allow IMD 102 to pass in a proximal
Atty Ref. No: A0011315WO01 direction P from a position distal to receptacle distal end 110 to the position within receptacle volume 112. In examples, medical system 100 is configured to deploy IMD 102 from device receptacle 108 (e.g., from a position within receptacle volume 112) and through receptacle opening 111 to cause IMD 102 to engage tissues at or in proximity to a target site 104. In examples, medical system 100 is configured to cause IMD 102 to disengage from tissues within target site 104 to, for example, retrieve IMD 102 from and/or reposition IMD 102 within heart 101. [0028] Delivery tool 106 is configured to deliver device receptacle 108 and/or IMD 102 to an anatomical volume of the patient (e.g., a chamber of heart 101, such as right ventricle (“RV”), right atrium (“RA”), left ventricle (“LV”), left atrium (“LA”), another anatomical volume of heart 101, and/or another anatomical volume of the patient). Optionally, delivery tool 106 may be advanced to the anatomical volume of the patient through a surrounding tubular member (not shown), such as a sheath or guide tool, which may be placed with its distal end in the anatomical volume before delivery tool 106 is advanced through the surrounding tubular member. In examples, delivery tool 106 is configured to retrieve device receptacle 108 and/or IMD 102 from the anatomical volume of the patient. [0029] Delivery tool 106 includes a body 107 (“tool body 107”) defining a lumen 118 (“delivery lumen 118”) which opens into receptacle volume 112. Delivery tool 106 (e.g., tool body 107) may include a distal portion 114 (“delivery tool distal portion 114”) configured to position intracorporeal to the patient and/or intracardiac to heart 101. Delivery tool 106 (e.g., tool body 107) may include a proximal portion 116 (“delivery tool proximal portion 116”) which may be configured to position extracorporeal to the patient and/or extracardiac to heart 101 (e.g., outside of a chamber of heart 101) when delivery tool distal portion 114 is positioned intracorporeal to the patient and/or intracardiac to heart 101. In examples, delivery tool distal portion 114 supports (e.g., is attached to and/or is a substantially unitary component with) device receptacle 108. [0030] In examples, medical system 100 includes a delivery system 120 configured to engage IMD 102 when, for example, IMD 102 is positioned within receptacle volume 112. Delivery system 120 includes a delivery system body 122 that may include a distal portion 124 (“delivery system body distal portion 124”) configured to be intracorporeal to the patient and a proximal portion 126 (“delivery system body proximal portion 126”) which
Atty Ref. No: A0011315WO01 may be extracorporeal to the patient when delivery system body distal portion 124 is intracorporeal. In examples, delivery system 120 includes a head portion 128 configured to engage IMD 102. At least delivery system body 122 may be configured to slidably translate and/or rotate within delivery lumen 118 (e.g., translate and/or rotate relative to delivery tool 106). Delivery system 120 may be configured such that the translation and/or rotation of delivery system body 122 causes delivery system body 122 and/or head portion 128 to impart translational and/or rotational forces on IMD 102, such that IMD 102 translates and/or rotates relative to receptacle wall 113. For example, delivery system 120 may be configured to translate within delivery lumen 118 to impart (e.g., via head portion 128) a translational force on IMD 102 causing IMD 102 to translate (e.g., within receptacle volume 112) in the proximal direction P or the distal direction D relative to receptacle wall 113. Delivery system 120 may be configured to rotate within delivery lumen 118 to impart (e.g., via head portion 128) a rotational force on IMD 102 causing IMD 102 to rotate (e.g., within receptacle volume 112) about a longitudinal axis L defined by delivery tool 106 and/or a device axis LD defined by IMD 102. In some examples, head portion 128 and delivery system body 122 may be substantially separate components. In some examples, head portion 128 may be substantially contiguous with delivery system body 122, such that head portion 128 and delivery system body 122 define a unified component. In FIG.1, portions of delivery system body 122 and/or head portion 128 positioned within delivery lumen 118 and/or receptacle volume 112 are depicted with dashed lines. [0031] Delivery system 120 can be used to, e.g., advance IMD 102 distally from device receptacle 108, through receptacle opening 111, to deploy IMD 102 into an anatomical volume. Delivery system 120 can also be used to, e.g., extract and/or retract IMD 102 from the anatomical volume, through receptacle opening 111, into device receptacle 108. Delivery system 120 and/or component(s) thereof, such as delivery system body 122, can comprise any suitable catheter or elongate member, or inner member (e.g., relative to delivery tool 106). Delivery system 120 and/or delivery system body 122 and/or head portion 128 can possess sufficient column strength or ”pushability” to advance IMD 102 distally from device receptacle 108, e.g., in the process of deployment, and/or, in some embodiments, to advance IMD 102, or delivery system 120 itself without IMD 102 attached thereto, along the length of delivery tool 106 including proximal portion 116 and
Atty Ref. No: A0011315WO01 distal portion 114 thereof. Delivery system 120, delivery system body 122, and/or head portion 128 may possess sufficient tensile strength to extract and/or retract IMD 102 from the anatomical volume, through receptacle opening 111, into device receptacle 108, and/or, in some embodiments, through the length of delivery tool 106 including delivery system proximal portion 126 and delivery system body distal portion 124 thereof. Delivery system 120, delivery system body 122 and/or head portion 128 may possess sufficient torque transmission capability to screw and/or unscrew IMD 102 into target tissue in the anatomical volume. Where IMD 102 is attached to target tissue without need for screwing or rotating (e.g. where IMD 102 is fixated via one or more tines), or where other component(s) perform the screwing/unscrewing function, delivery system 120, delivery system body 122 and/or head portion 128 need not possess this capability. [0032] Receptacle wall 113 may be configured to allow a clinician to determine a position of IMD 102 when IMD 102 is within receptacle volume 112. In examples, receptacle wall 113 is configured to provide a visual indication indicative of a position of IMD 102 within receptacle volume 112. The visual indication may assist a clinician during deployment of IMD 102 using delivery tool 106 when device receptacle 108 is observable by the clinician (e.g., prior to a procedure, during an open-heart procedure, or during another period). For example (e.g., during an open-heart procedure), receptacle wall 113 may be configured to provide a visual indication indicative of a position of IMD 102 within receptacle volume 112 to allow the clinician to assess a likely position of IMD 102 within heart 101 (e.g., relative to the TV) prior to deployment of IMD 102 from device receptacle 108. In examples, at least some portion of receptacle wall 113 is transparent, such that at least some portion of IMD 102 is visible as IMD 102 is positioned within device receptacle 108. In examples, at least some portion of receptacle wall 113 defines a window (e.g., an opening in addition to receptacle opening 111) through which at least some portion of IMD 102 is visible as IMD 102 is positioned within device receptacle 108. In some examples, an outer surface defined by receptacle wall 113 may include a mark M1 which corresponds to position of IMD 102 within device receptacle 108. For example, mark M1 may correspond to an expected position of some portion of IMD 102 (e.g., a proximal end or some other portion) within device receptacle 108 when IMD 102 is loaded into device receptacle 108. [0033] IMD 102 may include attachment member 132 configured to engage tissues
Atty Ref. No: A0011315WO01 within target site 104. In some examples, attachment member 132 defines one or more tines or other structures configured to engage tissue within target site 104 when a force is imparted to IMD 102 (e.g., a force in the distal direction D). Medical system 100 (e.g., delivery system body 122 and/or head portion 128) may be configured to impart the force to IMD 102 to cause attachment member 132 to engage tissues (e.g., tissue within target site 104). In examples, delivery system body 122 is configured to receive the force (e.g., from a clinician) and transfer the force to IMD 102 (e.g., via head portion 128 or another portion of delivery system 120). Attachment member 132 may be configured to disengage from tissues of target site 104 when a force in the proximal direction P is imparted to IMD 102. In some examples, attachment member 132 defines a helix or other structure configured to engage tissue within target site 104 when a torque is imparted to IMD 102 (e.g., a torque about longitudinal axis L). Medical system 100 (e.g., delivery system body 122 and/or head portion 128) may be configured to impart the torque to IMD 102 to cause attachment member 132 to engage tissues (e.g., tissue within target site 104). In examples, delivery system body 122 is configured to receive the torque (e.g., from a clinician) and transfer the torque to IMD 102 (e.g., via head portion 128 or another portion of delivery system 120). In some examples, attachment member 132 is configured to disengage from tissues of target site 104 when a second torque in a direction opposite the torque causing engagement is imparted to IMD 102. [0034] Delivery tool 106 is be configured (e.g., under the influence of a clinician) to position device receptacle 108 and IMD 102 in proximity to target site 104. In some examples, for example during an open-heart surgery, delivery tool 106 is configured to deliver and/or retrieve device receptacle 108 and/or IMD 102 via an access 133 to an interior of heart 101 created by a clinician during a surgical procedure (e.g., an atriotomy). For example, the clinician may create access 133 substantially through an outer wall of heart 101 during a surgical procedure such as an open-heart surgery or another surgical procedure. Delivery tool 106 may be configured to deliver device receptacle 108 (e.g., via access 133) through the RA of heart 101, through a tricuspid valve TV of heart 101, and into the RV of heart 101 to position device receptacle 108 and/or IMD 102 in proximity to a target site such as target site 104. In examples, target site 104 is a site in a low septal wall (“SW”) of the RV. [0035] Delivery tool 106 may be configured to position device receptacle 108 and/or
Atty Ref. No: A0011315WO01 IMD 102 (e.g., attachment member 132) in proximity to and/or contact with target sites located elsewhere within heart 101 and/or located in other anatomical volumes of the patient in other examples. In some examples, delivery tool 106 is configured to deliver and/or retrieve device receptacle 108 and/or IMD 102 using vasculature of a patient, such as an IVC or other vasculature leading to the anatomical volume. [0036] Delivery tool 106 includes a shapeable body 134 configured to be bendable (e.g., by a clinician) to ease a transit of delivery tool 106 through one or more anatomical volumes defined by a patient. Delivery lumen 118 extends through shapeable body 134. In some examples, shapeable body 134 comprises a portion of tool body 107. In some examples, shapeable body 134 comprises substantially all of tool body 107. Shapeable body 134 extends from a proximal end 140 of shapeable body 134 (“shapeable body proximal end 140”) to a distal end 142 of shapeable body 134 (“shapeable body distal end 142”). In examples (e.g., when shapeable body 134 comprises substantially all of tool body 107), shapeable body proximal end 140 defines a proximal end of tool body 107 and/or shapeable body distal end 142 defines a distal end of tool body 107. In examples, delivery tool 106 defines a length (e.g., from shapeable body proximal end 140 to receptacle distal end 110) of from about 6 inches and to about 14 inches, in some examples from 8 inches to about 12 inches. Delivery tool 106 may define other lengths (e.g., from shapeable body proximal end 140 to receptacle distal end 110) in other examples. [0037] Shapeable body 134 is configured to define one or more curves in response to the bending (e.g., by the clinician). Shapeable body 134 is configured to retain the one or more curves caused by the bending as delivery tool 106 transits through the one or more anatomical volumes. For example, shapeable body 134 may be caused (e.g., through application of a bending force by the clinician) to define a first curve CV1 and/or a second curve CV2 to ease the transit of delivery tool 106 (e.g., a transit through the RA, the TV, into the RV, and into proximity of target site 104 of heart 101). Delivery tool 106 (e.g., shapeable body 134) is configured to retain first curve CV1 and/or a second curve CV2 during the transit of delivery tool 106. [0038] The retention of curves by shapeable body 134 allows delivery tool 106 to substantially mimic a particular transit path of delivery tool 106 that may be desired to place device receptacle 108 and/or 102 within proximity to target site 104 within a patient,
Atty Ref. No: A0011315WO01 and/or minimize a potential for interference with other anatomical structures (e.g., the TV) during a delivery. For example, the particular transit path may be a path visualized, observed, and/or otherwise assessed by a clinician in order to place device receptacle 108 and/or 102 within proximity to target site 104. Delivery tool 106 is configured such that the clinician may apply bending forces to shapeable body 134 to generate, for example, curve CV1 and/or curve CV2, such that delivery tool 106 substantially mimics the particular transit path visualized, observed, and/or otherwise assessed. Delivery tool 106 (e.g., shapeable body 134) is configured to retain the curves (e.g., curve CV1 and/or curve CV2) generated by the clinician as the clinician causes delivery tool 106 to transit toward target site 104 (e.g., via access 133). [0039] For example, FIG.2 schematically illustrates delivery tool 106 and heart 101 prior to insertion of delivery tool 106 within heart 101 of a patient (e.g., via access 133). A situation similar to FIG.2 may be present, for example, during an open-heart surgery on heart 101, when a clinician may have a relatively unencumbered view of heart 101. The clinician may visualize, observe, and/or otherwise assess a desired transit path of delivery tool 106 through heart 101 of the patient. The clinician may bend shapeable body 134 (e.g., to define curve CV1 and/or curve CV2) such that delivery tool 106 substantially mimics the transit path visualized, observed, and/or otherwise assessed for the patient. Delivery tool 106 is configured to retain the curves generated by the clinician as delivery tool 106 transits toward target site 104 (e.g., via access 133) to assist in, for example, delivery of IMD 102 to target site 104 within the patient. [0040] Shapeable body 134 is configured such that first curve CV1, second curve CV2, or other curves may be defined (e.g., through bending force imparted by a clinician) at any one of a variety of locations on shapeable body 134. Shapeable body 134 may be configured such first curve CV1, second curve CV2, or the other curve may define any angle of curvature over a range of angles of curvature. Shapeable body 134 may be configured such that curve CV1, curve CV2, and/or other curves may be produced (e.g., in response to one or more bending forces imparted by a clinician) at locations and with curvatures specific to a particular patient, such that delivery tool 106 substantially mimics a transit path visualized, observed, and/or otherwise assessed for the particular patient. Further, shapeable body 134 may be configured such that first curve CV1 extends through a first plane-of-curvature, second curve CV2 extends through a second plane-of curvature
Atty Ref. No: A0011315WO01 different from the first plane-of-curvature, and curves defined by shapeable body 134 extend through a respective planes-of-curvature different from the first plane-of-curvature and the second plane-of curvature. Hence, shapeable body 134 may be configured to define a plurality of curves (e.g., in response to bending forces) to substantially mimic a wide variety of transit paths, depending on a specific transit path visualized, observed, and/or otherwise assessed by a clinician for a given patient. [0041] For example, shapeable body 134 may be configured to define a wide variety of paths through three-dimensional space as shapeable body 134 extends from shapeable body proximal end 140 to shapeable body distal end 142. Shapeable body 134 may be configured to define a path from shapeable body proximal end 140 to shapeable body distal end 142 using first curve CV1, second curve CV2, and/or other curves caused by the impartation of bending forces (e.g., by a clinician) on shapeable body 134. Hence, shapeable body 134 is configured such that a clinician may visualize, observe, and/or otherwise assess a specific transit path for a given patient and impart bending forces to cause shapeable body 134 to define a path from shapeable body proximal end 140 to shapeable body distal end 142 which substantially mimics the specific transit path. [0042] Although FIG.2 depicts a situation providing a relatively unencumbered view of heart 101, this is not required for use of delivery tool 106. Delivery tool 106 may be utilized in minimally invasive heart procedures or other procedures for delivery of a medical device such as IMD 102 to an anatomical volume of a patient. A clinician may bend shapeable body 134 to cause delivery tool 106 to substantially mimic a transit path visualized, observed, and/or otherwise assessed for the minimally invasive heart procedure or other procedure for delivery of the medical device. [0043] In some examples, shapeable body 134 includes one or more rigid portions configured to serve as a location for the impartation of a bending force to, for example, minimize the impartation of bending forces on certain portions of delivery tool 106 (e.g., device receptacle 108). A rigid portion may be configured to retain a shape when a bending force is imparted to the rigid portion, or configured (e.g., resiliently biased) to return to an initial shape present prior to the impartation when the bending force ceases to act on the rigid portion. In examples, a rigid portion of the one or more rigid portions is a portion of shapeable body 134 located substantially between shapeable body proximal end 140 and shapeable body distal end 142. In some examples, the rigid portion defines
Atty Ref. No: A0011315WO01 shapeable body proximal end 140 or shapeable body distal end 142. The rigid portion may be configured to cause another portion of shapeable body 134 to alter its curvature (e.g., to define first curve CV1 or second curve CV2) when a bending force is imparted to the rigid portion (e.g., by a clinician). In some examples, the rigid portion is a first portion of shapeable body 134 which is unitary (e.g., materially contiguous with) another portion of and/or a remainder of shapeable body 134. In some examples, the rigid portion defines a substantially rigid layer of shapeable body 134 (e.g., a layer overlaid some portion of shapeable body outer surface 148 or positioned within shapeable body 134 under shapeable body outer surface 148). [0044] For example, shapeable body 134 may include a coupler 145 (FIG.1) configured to couple shapeable body 134 and device receptacle 108. In examples, coupler 145 is a portion of shapeable distal portion 144. Coupler 145 may be configured to retain a shape when a bending force is imparted to coupler 145, or configured to return to an initial shape of coupler 145 present prior to the impartation when the bending force ceases to act on coupler 145. Coupler 145 may be located on shapeable body 134 to, for example, discourage the application of bending forces to device receptacle 108, which, in some examples, might impact a position of IMD 102 within receptacle volume 112. [0045] In some examples, delivery tool 106 may include a pre-shaped, fixed curve configured to assist in the delivery of IMD 102 and/or device receptacle 108 to target site 104. For example, tool body 107 and/or shapeable body 134 may define a fixed curve FC (e.g., a J-shaped curve) configured to assist in the delivery of IMD 102. Fixed curve FC may be based on an orientation of device receptacle 108 and/or IMD 102 expected to be favorable when medical system 100 delivers device receptacle 108 and/or IMD 102 using a particular transit path. For example, fixed curve FC may be configured to generally orient device receptacle 108 such that receptacle distal end 110 substantially faces toward the septal wall (SW) of heart 101 when the particular transit path defines a path into the RV via the TV. [0046] In examples, delivery tool 106 (e.g., shapeable body 134) includes one or more markings observable by the clinician to substantially indicate a location of device receptacle 108 and/or IMD 102 (e.g., within heart 101) as delivery tool transits toward target site 104. For example, delivery tool 106 may include a mark M2 on an outer surface 136 (“tool outer surface 136”) configured to indicate when device receptacle 108 and/or
Atty Ref. No: A0011315WO01 IMD 102 is in proximity to a first anatomical location and/or structure of the patient (e.g., the TV of heart 101) as deliver tool 106 transits to target site 104 (e.g., via access 133). Delivery tool 106 may include a mark M3 on tool outer surface 136 configured to indicate when device receptacle 108 and/or IMD 102 is in proximity to a second anatomical location and/or structure of the patient (e.g., a target site 104 in lower septal wall of heart 101) as deliver tool 106 transits to target site 104 (e.g., via access 133). In examples, tool outer surface 136 includes at least some portion of an outer surface defined by shapeable body 134. In examples, a mark (e.g., mark M2 or mark M3) is configured to define a distance between the mark and a reference point on medical system 100, such as reference point P1 (FIG.2) on device receptacle 108 (e.g., receptacle distal end 110). The marks may be configured to allow the clinician to insert the shaped delivery tool 106 into an anatomical volume (e.g., the RA of heart 101) and assess a location of device receptacle 108 and/or IMD 102 as delivery tool 106 transits toward target site 104. [0047] In some examples, tool outer surface 136 is configured to retain a mark of, for example, a biocompatible ink delivered by a medical marking device 138. In examples, medical marking device 138 is a marker or other device configured to be controlled (e.g., held) by a clinician, such that the clinician may use medical marking device 138 to produce one or more marks such as mark M2 and/or mark M3. Hence, delivery tool 106 may be configured such that a clinician may visualize, observe, and/or otherwise assess a transit path of delivery tool 106 within a particular patient and generate one or more markings on tool outer surface 136 to assess a location of device receptacle 108 and/or IMD 102 as delivery tool 106 transits toward target site 104 within the particular patient (e.g., as delivery tool 106 substantially mimics the transit path visualized, observed, and/or otherwise assessed for the particular patient.). [0048] In some examples, the one or more marks of tool outer surface 136 may be pre- marked, substantially permanent markings. For example, mark M2, M3 may be pre- marked on shapeable body 134 to indicate a representative distance along tool outer surface 136 indicative of when device receptacle 108 and/or IMD 102 is in proximity to a specific anatomical location and/or structure of a representative patient. Marks M2, M3 may be located to allow the clinician to insert the shaped delivery tool 106 into an anatomical volume of a given patient undergoing a procedure and assess a location of device receptacle 108 and/or IMD 102 within the patient based on the representative
Atty Ref. No: A0011315WO01 distances defined by the pre-marked, substantially permanent markings. [0049] In some examples, tool outer surface 136 defines a first zone exhibiting a first visual aspect and a second zone exhibiting a second visual aspect different from the first visual aspect. For example, the first zone may extend distal to a marker (e.g., mark M2 or mark M3) and the second zone may extend proximal to the marker (e.g., mark M2 or mark M3). The first visual aspect may be, for example, one of a first color of tool outer surface 136, a first pattern on and/or defined by tool outer surface 136, and/or another first visual marking of tool outer surface 136. The second visual aspect may be, for example, at least one of a second color of tool outer surface 136, second pattern on and/or defined by tool outer surface 136, or another visual aspect of tool outer surface 136 which is visually distinct from the first visual aspect. In some examples, a zone (e.g., the first zone or the second zone) may extend between mark M2 and mark M3. The first zone and the second zone may assist a clinician in more efficiently assessing the location of device receptacle 108 and/or IMD 102 as delivery tool 106 transits toward target site 104. [0050] In examples, delivery tool 106 is configured to provide (e.g., to a clinician) an indication of a rotational orientation of shapeable body 134 and/or device receptacle 108 (e.g., a rotational orientation relative to the RA, the RV, the TV, or another portion of heart 101). Delivery tool 106 may be configured to provide (e.g., to the clinician) an indication of a degree of rotation of shapeable body 134 and/or device receptacle 108 (e.g., a degree of rotation about longitudinal axis L). For example, delivery tool 106 may include a mark M4 (e.g., on tool outer surface 136) which indicates a rotational orientation of shapeable body 134 and/or device receptacle 108 relative to the RA, the RV, the TV, or another portion of heart 101. Mark M4 may be configured to rotate around longitudinal axis L when shapeable body 134 and/or device receptacle 108 rotates about longitudinal axis L such that a rotational displacement of mark M4 is indicative or a rotation of shapeable body 134 and/or device receptacle 108. In examples, mark M4 is a substantially permanent mark on shapeable body outer surface 148 and/or tool outer surface 136. Mark M4 may have any length and may extend over any length of delivery tool 106. For example, mark M4 may extend over some portion of or extend substantially over the entirety of a length of shapeable body 134. [0051] In examples, shapeable body 134 includes a distal portion 144 (“shapeable distal portion 144”) and a proximal portion 146 (“shapeable proximal portion 146”). Tool
Atty Ref. No: A0011315WO01 body 107 may define shapeable distal portion 144 and shapeable proximal portion 146. In examples, shapeable distal portion 144 supports (e.g., is mechanically coupled to) device receptacle 108. Delivery tool 106 may be configured such that delivery lumen 118 extends through shapeable proximal portion 146 and shapeable distal portion 144. In examples, shapeable body 134 is configured such that shapeable distal portion 144 may define and retain a first curve (e.g., curve CV1) or a first plurality of curves as shapeable proximal portion 146 defines and retains a second curve (e.g., curve CV2) or a second plurality of curves. In examples, shapeable body 134 comprises at least some portion of delivery tool distal portion 114. In examples, mark M4 extends substantially from shapeable proximal portion 146 to shapeable distal portion 144. [0052] Hence, medical system 100 may be configured to ease a transit of delivery tool 106, device receptacle 108, and/or IMD 102 through one or more anatomical volumes defined by a patient enroute to target site 104. In examples, medical system 100 is configured to substantially mimic a particular transit path within a patient visualized, observed, and/or otherwise assessed by a clinician. Delivery tool 106 includes a shapeable body 134 configured to be bendable (e.g., by a clinician) to define one or more curves to substantially mimic the particular transit path. Shapeable body 134 is configured to retain the one or more curves as delivery tool 106 transits (e.g., is caused to transit by the clinician) through the one or more anatomical volumes. [0053] Although the examples herein discuss delivery, retrieval, and/or positioning of IMD 102 within the RV of heart 101, medical system 100 may be configured to deliver, retrieve, and/or position IMD 102 in any of the other chambers of heart 101 and/or in other anatomical volumes of a patient in a like manner as that described for the RV of heart 101. Further, although the examples herein discuss target site 104 as a target site substantially on or within lower septal wall of heart 101, medical system 100 may be configured to deliver device receptacle 108 and/or IMD 102 in proximity to a target site in any portion of heart 101, and may be configured to retrieve IMD 102 from any portion of heart 101. Further, although the examples herein discuss transit of delivery tool 106 via access 133, delivery tool 106 may transit via other accesses, including accesses naturally defined by a patient and accesses naturally formed by the body of the patient. [0054] FIG.3 is a schematic plan view of medical system 100 including shapeable body 134 in a first configuration. In the first configuration, shapeable body 134 (e.g.,
Atty Ref. No: A0011315WO01 shapeable distal portion 144) defines a first curvature C1 of substantially zero (e.g., shapeable distal portion 144 is substantially straight). FIG.4 is a schematic plan view of medical system 100 with shapeable body 134 in a second configuration. In the second configuration, shapeable body 134 (e.g., shapeable distal portion 144) defines a second curvature C2 different from first curvature C1. FIG.5 is a schematic plan view of medical system 100 with shapeable body 134 (e.g., shapeable proximal portion 146) having transitioned from defining a third curvature C3 of FIG.3 and FIG.4 to defining a fourth curvature C4. In FIG.3 and FIG.4, third curvature C3 is substantially zero (e.g., shapeable proximal portion 146 is substantially straight). [0055] Delivery lumen 118 extends at least from shapeable body proximal end 140 to shapeable body distal end 142 and opens into receptacle volume 112 of device receptacle 108. In examples, delivery tool 106 (e.g., tool body 107) defines longitudinal axis L extending at least from shapeable body proximal end 140 to shapeable body distal end 142. Longitudinal axis L may extend through delivery lumen 118. In some examples, longitudinal axis L extends through receptacle volume 112 and receptacle opening 111. Longitudinal axis L (and/or portions thereof) may be linear, curved, and/or curvilinear depending on a curvature (or substantial lack thereof) of shapeable body 134. As discussed, tool body 107 may extend proximal to shapeable body 134 and shapeable body proximal end 140 in some examples. In other examples, shapeable body 134 may define substantially an entirety of tool body 107. [0056] For example, as depicted in FIG.3, a first portion of longitudinal axis L extending through shapeable distal portion 144 may be substantially linear when shapeable distal portion 144 defines a first curvature C1 of substantially zero (e.g., when shapeable distal portion 144 is substantially straight). The first portion L1 of longitudinal axis L may be curved when, as depicted in FIG.4, shapeable distal portion 144 defines a second curvature C2 different from first curvature C1. Similarly, a second portion L2 of longitudinal axis L extending through shapeable proximal portion 144 may be substantially linear when shapeable proximal portion 146 defines a third curvature C3 of substantially zero (e.g., when shapeable proximal portion 144 is substantially straight), and may be curved when shapeable proximal portion 146 defines fourth curvature C4 different from third curvature C3. [0057] Shapeable body 134 defines an outer surface 148 (“shapeable body outer
Atty Ref. No: A0011315WO01 surface 148”) facing in a direction away from longitudinal axis L (e.g., away from first portion L1 and/or second portion L2). Shapeable body outer surface 148 may extend from shapeable body proximal end 140 to shapeable body distal end 142. In examples, shapeable body outer surface 148 surrounds longitudinal axis L as longitudinal axis L extends from shapeable body proximal end 140 to shapeable body distal end 142. In some examples, shapeable body 134 defines an inner surface 150 (“shapeable body inner surface 150”) opposite shapeable body outer surface 148. Shapeable body inner surface 150 may be configured to define delivery lumen 118 between shapeable body proximal end 140 and shapeable body distal end 142. [0058] Shapeable body 134 configured to bend and/or flex to alter its curvature in response to a bending force F1 (FIG.4) imparted to shapeable body 134. In examples, shapeable body 134 is configured to receive bending force F1 from a clinician in order to cause shapeable body 134 to define a curve such as first curve CV1. Shapeable body 134 is configured to retain first curve CV1 when bending force F1 ceases to act on shapeable body 134 (e.g., when the clinician ceases to impart bending force F1). In some examples, shapeable body 134 is configured to bend and/or flex in response to a hand force delivered by the clinician, such that the clinician may manipulate shapeable body 134 to define a shape anticipated to ease a transit of delivery tool 106 over transit path visualized, observed, and/or otherwise assessed by the clinician. For example, shapeable body 134 may be configured to bend and/or flex to define one or more curves (e.g., first curve CV1) in response to a bending force F1 (e.g., delivered by the clinician) of less than or equal to about 10 pound-force. [0059] Shapeable body 134 may be configured to receive bending force F1 in any manner. For example, shapeable body 134 may be configured to receive bending force F1 via an impartation of bending force F1 on catheter outer surface 136 and/or shapeable outer surface 148. Shapeable body 134 may be configured such that a clinician may impart bending force F1 on catheter outer surface 136 and/or shapeable outer surface 148 using, for example, a tool or a digit of the clinician’s hand. In some examples, shapeable body 134 is configured to receive bending force F1 from a component (e.g., an elongate body) configured to cause bending force F1. The component may be configured to impart bending force F1 when a force is imparted (e.g., by a clinician) on the component. For example, the component may be configured to impart bending force F1 to shapeable
Atty Ref. No: A0011315WO01 portion 134 in response to a pushing or pulling force exerted on the component (e.g., by the clinician). In examples, the component (e.g., an elongate body) is attached to and/or embedded within delivery body 107 and/or shapeable body 134. The component may be configured to transfer the force imparted (e.g., by a clinician) on the component to delivery body 107 and/or shapeable body 134 to cause bending force F1 on delivery body 107 and/or shapeable body 134. [0060] Shapeable body 134 may be configured to bend and/or flex to define a plurality of curves between shapeable body proximal end 140 and shapeable body distal end 142. For example, as depicted in FIG.5, shapeable body 134 may be configured such that shapeable distal portion 144 defines first curve CV1 as shapeable proximal portion 146 defines second curve CV2. Shapeable proximal portion 146 may be configured to bend and/or flex to define second curve CV2 in response to a second bending force F2 imparted to shapeable body 134 (e.g., imparted to shapeable proximal portion 146 by, for example, a clinician). Shapeable body 134 may further bend and/or flex in response to other bending forces imparted (e.g., by the clinician) at other locations to define other curves in addition to first curve CV1 and second curve CV2. Hence, delivery tool 106 may be configured to allow a clinician to manipulate shapeable body 134 (e.g., through impartation of bending forces) to define a plurality of curves over a plurality of locations on shapeable body 134, such that delivery tool 106 defines a desired shape between shapeable body proximal end 140 and shapeable body distal end 142. [0061] In examples, shapeable body 134 is configured to bend and/or flex by transitioning from the first configuration of FIG.3 to the second configuration of FIG.4 when bending force F1 acts on shapeable body 134. Shapeable body 134 defines first curvature C1 in the first configuration and defines second curvature C2 in the second configuration. As discussed, and as depicted in FIG.3, first curvature C1 may define a curvature of substantially zero when first curvature C1 is defined by a substantially straight portion of shapeable body 134. Second curvature C2 is different from first curvature C1. Thus, shapeable body 134 may be configured to bend and/or flex by altering a curvature defined by shapeable body 134 from first curvature C1 to second curvature C2 in response to bending force F1 acting on shapeable body 134, such that shapeable body 134 transitions from the first configuration to the second configuration. [0062] Shapeable body 134 is configured to retain the second configuration (e.g., to
Atty Ref. No: A0011315WO01 continue to define second curvature C2) when bending force F1 ceases to act on shapeable body 134. For example, shapeable body 134 may transition from the first configuration defining first curvature C1 to the second configuration defining second curvature C2 when a clinician imparts bending force F1 on shapeable body 134. Shapeable body 134 may continue to define second curvature C2 when the clinician ceases to impart bending force F1 on shapeable body 134. [0063] Shapeable body 134 may be configured to alter a curvature of longitudinal axis L when bending force F1 acts on shapeable body 134. In examples, first curvature C1 and second curvature C2 may be curvatures of longitudinal axis L determined with respect to a normal vector V1 perpendicular to and passing through longitudinal axis L. Shapeable body 134 may be configured to alter the curvature of longitudinal axis L with respect to normal vector V1 when shapeable body 134 transitions from the first configuration defining first curvature C1 to the second configuration defining curvature C2. [0064] For example, in some examples, second curvature C2 may define a curvature of longitudinal axis L with respect to normal vector V1 that is more positive or more negative than a curvature of longitudinal axis L with respect to normal vector V1 defined by first curvature C1. Similarly, first curvature C1 may define a curvature of longitudinal axis L with respect to normal vector V1 that is more positive or more negative than the curvature of longitudinal axis L with respect to normal vector V1 defined by second curvature C2. Hence, shapeable body 134 may be configured to alter the curvature of longitudinal axis L (e.g., to a more positive or a more negative curvature) when shapeable body 134 transitions from the first configuration defining first curvature C1 to the second configuration defining curvature C2. As an example, shapeable body 134 may alter the curvature of longitudinal axis L from first curvature C1 to second curvature C2 to cause shapeable proximal portion 146 to define first curve CV1. In some examples, shapeable body 134 is configured such that first curvature C1 may define an angle of curvature of greater than about 170 degrees and second curvature C2 may define an angle of curvature of less than about 120 degrees. [0065] In some examples, instead of or in addition to altering the curvature of longitudinal axis L, shapeable body 134 is configured to alter a curvature of shapeable body outer surface 148 when bending force F1 acts on shapeable body 134. For example, normal vector V1 may be perpendicular to and pass through shapeable body outer surface
Atty Ref. No: A0011315WO01 148. Shapeable body 134 may be configured to alter the curvature of shapeable body outer surface 148 with respect to normal vector V1 when shapeable body 134 transitions from the first configuration to the second configuration. For example, in some examples, second curvature C2 may define a curvature of shapeable body outer surface 148 with respect to normal vector V1 that is more positive or more negative than the curvature of shapeable body outer surface 148 with respect to normal vector V1 defined by first curvature C1. Similarly, first curvature C1 may define a curvature of shapeable body outer surface 148 with respect to normal vector V1 that is more positive or more negative than the curvature of shapeable body outer surface 148 with respect to normal vector V1 defined by second curvature C2. Hence, shapeable body 134 may be configured to alter the curvature of shapeable body outer surface 148 (e.g., to a more positive or a more negative configuration) when shapeable body 134 transitions from the first configuration defining first curvature C1 to the second configuration defining second curvature C2. Shapeable body 134 may alter the curvature of shapeable body outer surface 148 from first curvature C1 to second curvature C2 to cause shapeable proximal portion 146 to define first curve CV1. [0066] Shapeable body 134 may be configured to alter a curvature of longitudinal axis L and/or shapeable body outer surface 148 with respect to a normal vector V2 extending longitudinal axis L and/or shapeable body outer surface 148 to define second curve CV2 in a similar or same manner as that described when shapeable body 134 alters a curvature of longitudinal axis L and/or shapeable body outer surface 148 with respect to a normal vector V1. For example, shapeable body 134 may be configured to alter the curvature of longitudinal axis L from third curvature C3 (FIG.4) to fourth curvature C4 (FIG.5) to cause shapeable proximal portion 146 to define one or more curves such as second curve CV2 when shapeable distal portion 144 defines one or more curves such as first curve CV1. [0067] Shapeable body 134 may be configured to define a plurality of curves between shapeable body proximal end 140 and shapeable body distal end 142 such that the plurality of curves defines a plurality of planes-of-curvature. Hence, shapeable body 134 may be configured to define the plurality of curves to cause longitudinal axis L to define a path extending through a three-dimensional space. For example, FIG.6 is a schematic end view of the shapeable body 134 and device receptacle 108 of FIG.5, viewed in the
Atty Ref. No: A0011315WO01 proximal direction P. Shapeable body 134 may be configured to define first curve CV1 in a first plane-of-curvature PC1 (e.g., such that at least a segment of first portion L1 lies within first plane-of-curvature PC1). Shapeable body 134 may be configured to define second curve CV2 in a second plane-of-curvature PC2 (e.g., such that at least a segment of second portion L2 lies within second plane-of-curvature PC2). Second plane-of-curvature PC2 is different from first plane-of-curvature PC1. For example, in some examples (e.g., as depicted in FIG.6), second plane-of-curvature PC2 may intersect first plane-of- curvature PC1. In some examples, second plane-of-curvature PC2 may be parallel to first plane-of-curvature PC1. [0068] Shapeable body 134 may be configured to define other curves extending through a planes-of-curvature different from first plane-of-curvature PC1 and second plane-of curvature PC2. Hence, shapeable body 134 may be configured to define a plurality of curves (e.g., in response to bending forces) which cause longitudinal axis L to define a path extending through a three-dimensional space to, for example, substantially mimic a transit path visualized, observed, and/or otherwise assessed by a clinician for a given patient. [0069] For example, FIG.7 depicts delivery tool 106 defining a plurality of paths from shapeable body proximal end 140 to receptacle distal end 110 in a three-dimensional space defined by an x-axis, a y-axis perpendicular to the x-axis, and a z-axis perpendicular to the x-axis and the y axis. Shapeable body proximal end 140 is positioned at an origin G of the three-dimensional space defined by the x-axis, the y-axis, and the z-axis. In one example, shapeable body 134 defines a first plurality of curves 152 to cause delivery tool 106 to define a first path PT1 from shapeable body proximal end 140 to receptacle distal end 110. Shapeable body 134 may pass through a first set of points (C1, C2, C3,…,CN) defined by the x-axis, the y-axis, and the z-axis as delivery tool 106 defines first path PT1. In another example, shapeable body 134 defines a second plurality of curves 154 to cause delivery tool 106 to define a second path PT2 from shapeable body proximal end 140 to receptacle distal end 110. Shapeable body 134 may pass through a second set of points (D1, D2, D3,…,DN) defined by the x-axis, the y-axis, and the z-axis as delivery tool 106 defines second path PT2. In a further example, shapeable body 134 defines a third plurality of curves 156 to cause delivery tool 106 to define a third path PT3 from shapeable body proximal end 140 to receptacle distal end 110. Shapeable body 134 may pass through a
Atty Ref. No: A0011315WO01 third set of points (E1, E2, E3,…,EN) defined by the x-axis, the y-axis, and the z-axis as delivery tool 106 defines third path PT3. [0070] Shapeable body 134 is configured such that first path PT1, second path PT2, and third path PT3 may define different pathways through the three-dimensional space. For example, the first set of points (C1, C2, C3,…,CN) may include one or more points (e.g., one or more set elements) which are not present in the second set of points (D1, D2, D3,…,DN) and/or the third set of points (E1, E2, E3,…,EN). The second set of points (D1, D2, D3,…,DN) may include one or more points (e.g., one or more set elements) which are not present in the third set of points (E1, E2, E3,…,EN). In some examples, each of first path PT1, second path PT2, third path PT3, and/or other paths defined by shapeable body 134 define a set of points which define a range over the x-axis, a range over the y axis, and a range over the z-axis, such that shapeable body 134 defines a pathway through the three- dimensional space. [0071] Shapeable body 134 is configured to cause delivery tool 106 to define first path PT1, second path PT2, or third path PT3 in response to bending forces imparted to shapeable body 134 (e.g., by a clinician). Shapeable body 134 is configured to cause delivery tool 106 to retain (e.g., to continue defining) first path PT1, second path PT2, or third path PT3 when the bending forces cease to act on shapeable body 134 (e.g., when the clinician ceases to impart the bending forces). Hence, shapeable body 134 is configured such that a clinician may cause delivery tool 106 to define a wide variety of paths based on a specific path observed, visualized, and/or otherwise assessed by the clinician. [0072] In examples, shapeable body 134 includes at least one shapeable material 158 configured to define the one or more curves in response to bending force F1, F2 acting on shapeable material 158. Shapeable material 158 may be configured to retain the one or more curves when bending force F1, F2 ceases to act on shapeable material 158. In examples, shapeable material 158 is an inelastic deforming material configured to undergo an inelastic deformation when bending force F1, F2 acts on shapeable material 158. For example, shapeable material 158 may be configured to inelastically deform from an initial shape (e.g., one in which shapeable body 134 defines one of PT1, PT2, or PT3) to a subsequent shape (e.g., one in which shapeable body 134 defines another of PT1, PT2, or PT3) in response to bending force F1, F2 acting on the shapeable material 158. Shapeable material 158 may be configured to retain the subsequent shape when bending force F1, F2
Atty Ref. No: A0011315WO01 ceases to act on shapeable material 158. [0073] In some examples, shapeable body 134 is be configured to define a plurality of curves to cause longitudinal axis L to define a path extending through (e.g., being confined to) a two-dimensional space rather than extending through a three-dimensional space. For example, shapeable body 134 may be configured to define first curve CV1 substantially in a single plane-of-curvature, define second curve CV2 substantially in the single plane of curvature, and/or define other curves within the single plane of curvature. Further, when shapeable body 134 is configured to define a plurality of curves to cause longitudinal axis L to define a path extending through a three-dimensional space, shapeable body 134 may nonetheless define first curve CV1 substantially in the single plane-of-curvature, define second curve CV2 substantially in the single plane of curvature, and/or define other curves within the single plane of curvature. [0074] In examples, shapeable body 134 includes shapeable material 158 and one or more additional materials. Shapeable material 158 may be configured to cause at least some portion of the additional materials to define one or more curves (e.g., one of the first plurality of curves 152, the second plurality of curves 154, or the third plurality of curves 156) when shapeable material 158 defines the one or more curves (e.g., the one of the first plurality of curves 152, the second plurality of curves 154, or the third plurality of curves 156). In examples, the additional materials are bendable, flexible materials, such as a flexible tubing. For example, the additional materials may be configured to flex and/ bend from first curvature C1 to second curvature C2 in response to a bending force less than bending force F1 (e.g., its own weight), such that the additional materials flex and/or bend in response to bending forces less than shapeable material 158. Shapeable material 158 may be configured to cause the additional materials to retain second curvature C2 despite other forces (e.g., weight forces, other contact forces) acting on the additional materials. [0075] Shapeable material 158 may comprise any portion of shapeable body 134. For example, shapeable material 158 may extend from shapeable body proximal end 140 to shapeable body proximal end 142. In some examples, shapeable material 158 defines at least some portion of shapeable body outer surface 148 and/or shapeable body inner surface 150. In some examples, shapeable material 158 defines one of shapeable body outer surface 148 or shapeable body inner surface 150 and the additional material comprises the other of shapeable body outer surface 148 or shapeable body inner surface
Atty Ref. No: A0011315WO01 150. In some examples, shapeable material 158 defines an inner layer or inner body of shapeable body 134. For example, shapeable body 134 may be configured such that the additional materials define shapeable body outer surface 148 and shapeable body inner surface 150 and shapeable material 158 defines an inner layer between shapeable body outer surface 148 and shapeable body inner surface 150. In some examples, shapeable material 158 is substantially an elongate body (e.g., a wire or thin rod). In some examples, shapeable material 158 is a substantially tubular element configured to surround longitudinal axis L (e.g., a bendable bellows, a bendable coil, or another substantially tubular element). [0076] In examples, delivery system body 122 and/or shapeable body 134 includes a polymer material such as polyvinyl Chloride (PVC) and/or Pebax (available from Arkema S.A.) In some examples, shapeable material 158 is a wire configured to deform from an initial shape to a subsequent shape and retain the subsequent shape. The wire may be, for example, a stainless steel wire. In examples, the wire is a round Ben134 d-and-Stay Multipurpose 304 Stainless Steel Wire (available from McMaster-Carr). [0077] FIG.8 depicts a schematic plan view of a delivery tool 106 including one or more markings configured to indicate a location of device receptacle 108 and/or IMD 102 with respect to the one or more markings. FIG.9 depicts a schematic plan view of a delivery tool 106 including one or more zones configured to indicate a location of device receptacle 108 and/or IMD 102 with respect to the one or more zones. The one or more markings and/or one or more zones may be configured to provide a visual indication observable by a clinician to assist the clinician in assessing a location and/or orientation of device receptacle 108 and/or IMD 102 within heart 101. [0078] A mark and/or zone may be configured to define a distance over shapeable body outer surface 148 from the mark and/or the zone to a reference point on delivery tool 106. For example, as depicted in FIG.8, mark M3 may define a distance S1 over shapeable body outer surface 148 from mark M1 to reference point P1 on device receptacle 108 (e.g., receptacle distal end 110). Mark M2 may define a distance S2 over shapeable body outer surface 148 and/or tool outer surface 136 from mark M2 to reference point P1 on device receptacle 108 (e.g., receptacle distal end 110). Similarly, as depicted in FIG.9, a first zone Z1 may define a distance S3 over shapeable body outer surface 148 to reference point P1 on device receptacle 108 and/or a second zone Z2 may define a
Atty Ref. No: A0011315WO01 distance S4 over shapeable body outer surface 148 and/or tool outer surface 136 to reference point P1 on device receptacle 108 (e.g., receptacle distal end 110). Mark M1, mark M2, first zone Z1, and/or second zone Z2 may be configured to provide a visual indication observable by a clinician to assist the clinician in assessing a location of device receptacle 108 and/or IMD 102 within heart 101 when device receptacle 108 and/or IMD 102 may have limited visibility to the clinician. [0079] For example, when delivery tool 106 is deployed through access 133 of heart 101, portions of delivery tool 106 (e.g., some portion of distal shapeable portion 144 and/or device receptacle 108) may have limited visibility to a clinician as delivery tool 106 is deployed (e.g., by the clinician) toward target site 104. Delivery tool 106 may be configured such that the clinician may observe a position of mark M1, mark M2, first zone Z1, and/or second zone Z2 relative to, for example, some portion of access 133 to assess a proximity of device receptacle 108 and/or IMD 102 to target site 104 as delivery tool 106 is deployed. Delivery tool 106 may be configured such that the clinician may observe a change in the position of mark M1, mark M2, first zone Z1, and/or second zone Z2 (e.g., a displacement thereof) as delivery tool 106 is deployed to, for example, assess the resulting displacement of device receptacle 108 and/or IMD 102. For example, a specific mark or zone (e.g., mark M2 and/or zone Z2) may allow a clinician to assess a proximity of receptacle distal end 111 to the TV based on a position of the specific mark or zone relative to access 133 (FIG.1). A specific mark or zone (e.g., mark M3 and/or zone Z1) may allow a clinician to assess a proximity of receptacle distal end 111 to an apex of heart 101 based on a position of the specific mark or zone relative to access 133 (FIG.1). [0080] FIG.10 is a schematic plan view of device receptacle 108 holding IMD 102 within receptacle volume 112, with device receptacle 108, shapeable body 134, and coupler 145 depicted as cross-sections with a cutting plane taken parallel to the page (e.g., parallel to longitudinal axis L). [0081] Receptacle wall 113 defines receptacle volume 112. In examples, receptacle wall 113 includes a body 160 (“wall body 160”) defining a wall inner surface 162. Wall inner surface 162 may define at least a portion of a boundary defining receptacle volume 112. In examples, wall inner surface 162 at least partially and/or substantially completely surrounds longitudinal axis L. In examples, wall body 160 defines receptacle opening 111. Wall body 160 may define receptacle opening 111 substantially at receptacle distal end
Atty Ref. No: A0011315WO01 110. Receptacle opening 111 may be configured such that IMD 102 may egress from within receptacle volume 112 (e.g., in the distal direction D) through receptacle opening 111 and/or ingress (e.g., in the proximal direction P) into receptacle volume 112 through receptacle opening 111. In examples, device axis LD defined by IMD 102 extends through at least some portion of receptacle volume 112 and extends through receptacle opening 111 when IMD 102 is positioned within receptacle volume 112. In examples, receptacle volume 112 is bounded at least partially by receptacle opening 111. [0082] Wall body 160 may define wall outer surface 164. In examples, at least some portion of wall body 160 is between wall outer surface 164 and wall inner surface 162. In examples, wall outer surface 164 at least partially and/or substantially completely surrounds longitudinal axis L and/or wall inner surface 162. Wall outer surface 164 may be configured such that wall outer surface 164 substantially faces in a direction away from longitudinal axis L, wall inner surface 162, and/or receptacle volume 112. [0083] In examples, delivery tool 106 (e.g., shapeable distal portion 144) defines a lumen opening 166 of delivery lumen 118 (“delivery lumen opening 166”) which opens into receptacle volume 112. Delivery lumen opening 166 is configured to allow at least some portion of delivery system body 122 to position within receptacle volume 112 when another portion of delivery system body 122 is positioned within delivery lumen 118. In examples, longitudinal axis L extends through delivery lumen opening 166. Receptacle volume 112 may be bounded at least partially by delivery lumen opening 166. In examples, receptacle volume 112 is bounded at least in part by delivery lumen opening 166, receptacle opening 111, and at least some portion of wall inner surface 162. In some examples, receptacle volume 112 defines a cross-sectional area perpendicular to longitudinal axis L, with the cross-sectional area defined by a curved, curvilinear, or polygonal boundary. In some examples, the cross-sectional area is defined by a substantially circular boundary. [0084] In examples, device receptacle 108 is a substantially rigid member and/or a substantially elastically deforming member configured to retain its shape when shapeable body 134 defines one or more curves (e.g., first curve CV1 and/or second curve CV2). Device receptacle 108 may be configured to retain its shape when shapeable body 134 transitions from the first configuration defining first curvature C1 to the second configuration defining curvature C2. In examples, device receptacle 108 is configured to
Atty Ref. No: A0011315WO01 maintain a receptacle volume shape of receptacle volume 112 when shapeable body 134 transitions from the first configuration to the second configuration. For example, device receptacle 108 may be configured to substantially maintain its cross-sectional area defined perpendicular to longitudinal axis L when shapeable body 134 transitions from the first configuration defining first curvature C1 to the second configuration defining curvature C2. [0085] Delivery system body 122 may extend through delivery lumen 118 of delivery tool 106. In examples, delivery system body 122 mechanically supports head portion 128. Head portion 128 is configured to engage IMD 102 within receptacle volume 112. In examples, head portion 128 is configured to engage a retrieval structure 168 of IMD proximal portion 172. Delivery system body 122 and/or head portion 128 are configured to translate within delivery lumen 118 in the distal direction D and/or proximal direction P relative to delivery tool 106 and device receptacle 108. In examples, delivery system body 122 and/or head portion 128 are configured to cause translation of IMD 102 in the proximal direction P and/or distal direction D relative to device receptacle 108 when delivery system 120 (e.g., head portion 128) engages IMD proximal portion 172 and delivery system body 122 and/or head portion 128 translates in the proximal direction P and/or distal direction D relative to delivery tool 106 and device receptacle 108. Delivery system 120 may be configured such that a force (e.g., in the proximal direction P and/or the distal direction D) exerted on delivery system body 122 (e.g., by a clinician) causes head portion 128 to transfer the force to IMD 102 when delivery system 120 (e.g., head portion 128) engages IMD 102. [0086] Delivery system body 122 and head portion 128 may be configured to rotate (e.g., within delivery lumen 118) about longitudinal axis L (e.g., relative to delivery tool 106 and device receptacle 108). Delivery system body 122 and/or head portion 128 may be configured to cause rotation of IMD 102 about device axis LD relative to device receptacle 108 when delivery system 120 (e.g., head portion 128) engages IMD proximal portion 172 and delivery system body 122 and/or head portion 128 rotate about delivery system axis LB relative to delivery tool 106 and device receptacle 108. Delivery system 120 may be configured such that a torque imparted on delivery system body 122 (e.g., by a clinician) causes delivery system 120 to transfer the torque to IMD 102 when delivery system 120 (e.g., head portion 128) engages IMD 102. In some examples, medical device
Atty Ref. No: A0011315WO01 (e.g., device receptacle 108) is configured to cause IMD 102 to translate (e.g., in the distal direction D or the proximal direction P) when delivery system 120 imparts the torque to IMD 102. For example, device receptacle 108 may define a set of threads (e.g., internal threads on a boundary of receptacle volume 112) configured to substantially mate with a portion of IMD 102 and/or a portion of head portion 128. The set of threads may be configured to cause IMD 102 and/or head portion 128 to translate relative to device receptacle 108 (e.g., receptacle wall 113) when delivery system 120 imparts the torque to IMD 102. [0087] In examples, delivery tool 106 is configured such that delivery system body distal portion 124 may slidably translate through delivery lumen opening 166 via delivery lumen 118, such that portions of delivery system body distal portion 124 may be positioned (e.g., by a clinician) within both delivery lumen 118 and receptacle volume 112. Delivery tool 106 and/or device receptacle 108 may be configured such that head portion 128 positions and/or translates (e.g., in the distal direction D and/or proximal direction P) within receptacle volume 112 and/or delivery lumen 118 when delivery system body distal portion 124 positions and/or translates within delivery lumen 118 and/or receptacle volume 112. In examples, delivery lumen 118 is configured to allow removal of delivery system 120 (e.g., by withdrawing proximally) from delivery tool 106 to, for example, insert another device within delivery lumen 118. [0088] Head portion 128 may comprise any suitable mating interface or abutment coupled to, or formed on or in, delivery system 120 and/or delivery system body 122 and configured to mate with, receive and/or abut IMD 102 (e.g., IMD proximal portion 172). Head portion 128 may be configured to provide a releasable attachment of IMD 102 to delivery system 120. In some examples, head portion 128 may be implemented via one or more releasable, removable, retractable or severable string(s), filament(s), thread(s), etc., or one or more snare(s) to provide a releasable attachment of IMD 102 to delivery system 120. Such string(s), filament(s), thread(s), snare(s), etc. can grip, loop through, anchor within, or otherwise interact with IMD 102 (e.g., IMD proximal portion 102) to facilitate such releasable attachment. [0089] In examples, IMD 102 includes processing circuitry 175 (“IMD processing circuitry 175”). Medical system 100 may be configured to use IMD processing circuitry 175 to sense an intrinsic electrical signal generated by heart 101 to, for example, assess
Atty Ref. No: A0011315WO01 electrical activity in proximity of IMD 102 (e.g., in proximity to attachment member 132), conduct pace mapping to determine a suitable placement of IMD 102, evaluate a suitability of pacing delivered by IMD 102 at a particular location, evaluate a position of IMD 102 during an implantation, evaluate a placement of a device electrode relative to a vessel wall, and/or for other reasons. In examples, IMD processing circuitry 175 is mechanically supported by a housing 170 of IMD 102 (“IMD housing 170”). IMD housing 170 may enclose processing circuitry 175 and/or other circuitry of IMD 102. IMD housing 170 may be configured to fluidly isolate processing circuitry 175 and/or other circuitry from an environment in contact with an exterior surface of IMD housing 170. In examples, IMD housing 170 is configured to hermetically seal an enclosure defined by IMD 102 and holding processing circuitry 175 and/or other circuitry. IMD housing 170 may be configured to define shapes that are easily accepted by the patient's body while minimizing patient discomfort. For example, IMD housing 170 may define a substantially cylindrical shape with cylindrical sidewalls. In other examples, IMD housing 170 may define substantially rectangular or other non-cylindrical shapes. IMD housing 170 may define shapes in which corners and edges are designed with relatively large radii, in order to present a housing having smoothly contoured exterior surfaces. In examples, attachment member 14 is coupled to IMD housing 170. [0090] In some examples, IMD 102 may mechanically support one or more device electrodes 176, such as but not limited to an IMD electrode 180 (e.g., supported by IMD distal portion 174, an IMD return electrode 182 supported by IMD housing 170, and/or other electrodes supported by IMD 102. Device electrodes 176 may be configured to communicate with processing circuitry 175 (e.g., IMD processing circuitry 175). Processing circuitry 175 may be configured to process and/or condition a signal sensed by device electrodes 176 and/or other electrodes within medical system 100. IMD 102, may comprise a pacemaker such as a leadless and/or wholly intracardiac pacemaker. One or more of device electrodes 176 may be electrically connected to processing circuitry 175. Processing circuitry 175 may be operable connected to operating circuitry configured to deliver therapy to a patient and/or sense physiological signals of the patient using device electrodes 176. [0091] Processing circuitry 175 may include fixed function circuitry and/or programmable operating circuitry. In examples, processing circuitry 175 includes
Atty Ref. No: A0011315WO01 circuitry configured to perform one or more functions of operating circuitry, such as therapy delivery circuitry, sensing circuitry, processing circuitry, switching circuitry, communication circuitry, and/or other circuitries. Processing circuitry 175, as well as other processors, operating circuitry, controllers, control circuitry, and the like, described herein, may include any combination of integrated circuitry, discrete logic circuity, analog circuitry, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), or field-programmable gate arrays (FPGAs). In some examples, processing circuitry 175 includes multiple components, such as any combination of one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry, and/or analog circuitry. [0092] Functions attributed to processing circuitry 175 may be embodied as software, firmware, hardware or any combination thereof. Processing circuitry 175 may include, for instance, a variety of capacitors, transformers, switches, and the like configured to perform the functions of processing circuitry 175. In examples, processing circuitry 175 may be configured to communicate with another device, such as a patient input/output device, a clinician input/output device, and/or others. Processing circuitry 175 may include any suitable hardware, firmware, software or any combination thereof for communicating with another device. In addition, processing circuitry 175 may communicate with a networked computing device and a computer network. In examples, processing circuitry 175 and/or other circuitry of medical system 100 is configured to deliver stimulation signals to and/or receive sensing signals from device electrodes 176 and/or other electrodes and/or sensors within medical system 100 or external to medical system 100. Processing circuitry 175 may be configured to provide electrical signals, e.g., pacing therapy, to device electrodes 176 and/or other electrodes within medical system 100. Processing circuitry 175 may be configured to receive electrical signals, e.g., sensed cardiac electrical signals, from device electrodes 176 and/or other electrodes within medical system 100. [0093] Medical system 100 (e.g., processing circuitry 175) can also include memory configured to store program instructions, such as software, which may include one or more program modules, which are executable by processing circuitry 175. The program instructions may be embodied in software and/or firmware. The memory can include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access
Atty Ref. No: A0011315WO01 memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically- erasable programmable ROM (EEPROM), ferroelectric RAM (FRAM), flash memory, or any other digital media. In some examples, the memory includes computer-readable instructions that, when executed by processing circuitry 175 cause processing circuitry 175 to perform various functions described herein and/or other functions of processing circuitry 175. [0094] As used here, when a first portion of a system (e.g., medical system 100) supports a second portion of the system, this means that when the second portion causes a first force to be exerted on the first portion, the first portion causes a second force to be exerted on the second portion in response to the first force. The first force and/or second force may be a contact force and/or an action-at-a-distance force. For example, first force and/or second force may be mechanical force, a magnetic force, a gravitational force, or some other type of force. The first portion of the system may be a portion of the system or a portion of a component of the system. The second portion of the system may be another portion of the system or another portion of the same component or a different component. In some examples, when the first portion of the system supports the second portion of the system, this may mean the second portion is mechanically supported by and/or mechanically connected to the first portion. [0095] A technique for supporting a device receptacle is illustrated in FIG.11. Although the technique is described mainly with reference to medical system 100 of FIGS. 1–10, the technique may be applied to other medical systems in other examples. [0096] The technique includes supporting, using a delivery tool 106, a device receptacle 108 (1102). Device receptacle 108 may define receptacle volume 112 holding an IMD 102. In examples, a shapeable body 134 of delivery tool 106 supports device receptacle 108. In examples, a shapeable distal portion 144 of shapeable body 134 supports device receptacle 108 and a shapeable proximal portion 146 of shapeable body 134 supports shapeable distal portion 144. In examples, a delivery system 120 extends through a delivery lumen 118 of delivery tool 106 and engage IMD 102 (e.g., IMD retrieval structure 168). Device receptacle 108 and shapeable body 134 are configured to insert within one or more anatomical volumes of a patient. [0097] The technique includes transitioning, using a bending force F1, F2, shapeable body 134 from a first configuration defining a first curvature C1 to a second configuration
Atty Ref. No: A0011315WO01 defining a second curvature C2 different from first curvature C1 (1104). In examples, the technique includes transitioning, using bending force F1, shapeable distal portion 144 from the first configuration to the second configuration. The technique may include transitioning, using bending force F2, shapeable proximal portion 146 from a third configuration defining a third curvature C3 to a fourth configuration defining a fourth curvature C4 different from third curvature C3. In examples, transitioning shapeable distal portion 144 includes defining second curvature C2 in a first plane of curvature. Transitioning shapeable proximal portion 146 may include defining fourth curvature C4 in a second plane of curvature different from the first plane of curvature. In examples, device receptacle 108 substantially maintains a shape of receptacle volume 112 when shapeable body 134 transitions from the first configuration to the second configuration. [0098] The technique includes retaining, using shapeable body 134, shapeable body 134 in the second configuration when bending force F1, F2 ceases to act on shapeable body 134 (1106). The technique may include inserting, using delivery tool 106, at least receptacle deice 108 and shapeable body 134 within the patient when shapeable body 134 defines second curvature C2 and/or fourth curvature C4. In examples, the technique includes displacing, using delivery tool 106, at least receptacle deice 108 and shapeable body 134 over a path from a right atrium of a heart 101, through a tricuspid annulus of heart 101, and into a right ventricle of heart 101 when shapeable body 134 defines second curvature C2 and/or fourth curvature C4. [0099] The technique may include marking, using a medical marking device 138, a shapeable body outer surface 148 of shapeable body 134. In examples, medical marking device 138 marks shapeable body outer surface 148 by dispensing a biocompatible ink. In examples, marking shapeable body outer surface 148 includes retaining, by shapeable body outer surface 148, the mark of biocompatible ink from medical marking device 138. [0100] In examples, the technique includes defining, using shapeable body outer surface 148, mark M2, M3 defining a distance along shapeable body outer surface 148 outer surface from mark M2, M3 to a reference point P1 on device receptacle 108. The technique may include defining, using outer surface 148, a first zone Z1 exhibiting a first visual aspect and a second zone Z2 exhibiting a second visual aspect different from the first visual aspect. In examples, first zone Z1 extends distal to mark M2, M3 and second zone Z2 extends proximal to mark M2, M3. In examples, the technique includes
Atty Ref. No: A0011315WO01 representing, using mark M2, M3 or a mark from medical marking device 138, a distance defined between a first anatomical structure of the patient and a second anatomical structure of the patient. The technique may include assessing, using mark M2, M3, a displacement of device receptacle 108 and/or shapeable body 134 (e.g., a displacement within the patient) based on a displacement of mark M2, M3 relative to the patient. [0101] The technique may include defining, using shapeable body outer surface 148, mark M1 indicative of a position of a portion of IMD 102 when IMD 102 is positioned within receptacle volume 112. The technique may include defining, using shapeable body outer surface 148, a mark M4 indicative of a rotational orientation of delivery tool 106. The technique may include assessing, using mark M4, a rotational displacement of device receptacle 108 and/or shapeable body 134 (e.g., a rotational displacement within the patient) based on a rotational displacement of mark M4 relative to the patient. [0102] Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims. [0103] Example 1. A medical system comprising: a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device; and a delivery tool supporting the device receptacle, wherein the delivery tool includes a shapeable body configured to transition from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature when a first bending force acts on the shapeable body, wherein the shapeable body is configured to retain the second configuration when the first bending force ceases to act on the shapeable body, wherein the delivery tool defines a delivery lumen extending through the shapeable body and a delivery lumen opening which opens into the receptacle volume, and wherein the device receptacle and the shapeable body are configured to insert within one or more anatomical volumes of a patient. [0104] Example 2. The medical system of Example 1, wherein the delivery lumen extends from a shapeable proximal portion of the shapeable body to a shapeable distal portion of the shapeable portion, wherein the shapeable distal portion is distal to the shapeable proximal portion. [0105] Example 3. The medical system of Example 2, wherein the shapeable distal portion supports the device receptacle.
Atty Ref. No: A0011315WO01 [0106] Example 4. The medical system of Example 2 or Example 3, wherein the shapeable distal portion is configured to define the first configuration and define the second configuration, wherein the shapeable proximal portion is configured to transition from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature when the shapeable distal portion defines one of the first configuration or the second configuration and a second bending force acts on the shapeable proximal portion, and wherein the shapeable body is configured to retain the fourth configuration when the second bending force ceases to act on the shapeable body. [0107] Example 5. The medical system of Example 4, wherein the shapeable distal portion is configured to define the second curvature in a first plane of curvature, and wherein the shapeable proximal portion is configured to define the fourth curvature in a second plane of curvature different from the first plane of curvature. [0108] Example 6. The medical system of any of Examples 1–5, wherein the device receptacle defines a receptacle opening which opens into the receptacle volume, and wherein the receptacle opening is configured to allow the implantable medical device to pass therethrough. [0109] Example 7. The medical system of any of Examples 1–6, wherein the shapeable body is configured to transition from the first configuration to the second configuration when the bending force is less than 10 pound-force. [0110] Example 8. The medical system of any of Examples 1–7, wherein the device receptacle defines a receptacle volume shape of a receptacle boundary bounding the receptacle volume, and wherein the device receptacle is a substantially rigid device configured to maintain the receptacle volume shape when the shapeable body transitions from the first configuration to the second configuration. [0111] Example 9. The medical system of any of Examples 1–8, wherein the first curvature defines an angle of curvature of greater than about 170 degrees and the second curvature defines an angle of curvature of less than about 120 degrees. [0112] Example 10. The medical system of any of Examples 1–9, wherein the shapeable body includes a surface surrounding and facing away from the delivery lumen, wherein the surface is configured to retain a mark of biocompatible ink from a medical marking device.
Atty Ref. No: A0011315WO01 [0113] Example 11. The medical system of any of Examples 1–10, wherein the shapeable body defines an outer surface surrounding and facing away from the delivery lumen, wherein the shapeable body includes one or more markings on the outer surface, and wherein each marking defines a distance along the outer surface from the each marking to a reference point on the device receptacle. [0114] Example 12. The medical system of Example 11, wherein the outer surface includes a first zone exhibiting a first visual aspect and a second zone exhibiting a second visual aspect different from the first visual aspect, wherein the first zone extends distal to a marking of the one or more markings, and where the second zone extends proximal to the marking of the one or more markings. [0115] Example 13. The medical system of Example 12, wherein the first visual aspect is at least one of a first color or a first pattern, and wherein the second visual aspect is at least one of a second color or a second pattern. [0116] Example 14. The medical system of any of Examples 11–13, wherein the distance defined by at least one of the one or more markers corresponds to a representative distance defined between a first anatomical structure of a representative patient and a second anatomical structure of the representative patient. [0117] Example 15. The medical system of any of Examples 1–14, wherein the shapeable body is configured to displace the device receptacle over a path from a right atrium of a representative heart, through a tricuspid annulus of the representative heart, and into a right ventricle of the representative heart. [0118] Example 16. The medical system of any of Examples 1–15, further comprising a delivery system configured to engage the implantable medical device, wherein the delivery system is configured to at least one of translate relative to the delivery tool or rotate relative to the delivery tool when the delivery system extends through the delivery lumen and into the receptacle volume. [0119] Example 17. The medical system of any of Examples 1–16, wherein the delivery tool is configured to displace the device receptacle over a path from a right atrium of a heart of the patient, through a tricuspid annulus of the heart, and into a right ventricle of the heart. [0120] Example 18. The medical system of any of Examples 1–17, wherein the implantable medical device comprises a leadless pacemaker.
Atty Ref. No: A0011315WO01 [0121] Example 19. A medical system comprising: a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device, a receptacle opening which opens into the receptacle volume, and a receptacle axis extending from the delivery lumen opening to the receptacle opening; and a delivery tool supporting the device receptacle, wherein the delivery tool defines a delivery lumen and a delivery lumen opening which opens into the receptacle volume, wherein the delivery tool includes a shapeable body including a shapeable proximal portion and a shapeable distal portion, the delivery lumen extending from the shapeable proximal portion to the shapeable distal portion, the shapeable distal portion supporting the device receptacle, and the device receptacle and the shapeable body configured to insert within one or more anatomical volumes of a heart of a patient, wherein the shapeable body is configured to transition from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature when a first bending force acts on the shapeable body, wherein the shapeable body is configured to retain the second configuration when the first bending force ceases to act on the shapeable body, wherein the device receptacle defines a receptacle volume shape of a receptacle boundary bounding the receptacle volume, and wherein the device receptacle is a substantially rigid device configured to maintain the receptacle volume shape when the shapeable body transitions from the first configuration to the second configuration. [0122] Example 20. The medical system of Example 19, wherein the shapeable distal portion is configured to define the first configuration and define the second configuration, wherein the shapeable proximal portion is configured to transition from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature when the shapeable distal portion defines one of the first configuration or the second configuration and a second bending force acts on the shapeable body, and wherein the shapeable body is configured to retain the fourth configuration when the second bending force ceases to act on the shapeable body. [0123] Example 21. The medical system of Example 20, wherein the shapeable distal portion is configured to define the first curvature in a first plane of curvature, and wherein the shapeable proximal portion is configured to define the fourth curvature in a second plane of curvature different from the first plane of curvature. [0124] Example 22. The medical system of any of Examples 19–21, wherein the
Atty Ref. No: A0011315WO01 shapeable body defines an outer surface surrounding and facing away from the delivery lumen, and wherein the outer surface includes one or more markings on the outer surface, and wherein each marking of the one or more markings defines a distance along the outer surface from the each marking to a reference point on the device receptacle. [0125] Example 23. The medical system of any of Examples 19–22, wherein the shapeable body includes a surface surrounding and facing away from the delivery lumen, wherein the outer surface is configured to retain a mark of biocompatible ink from a medical marker. [0126] Example 24. The medical system of any of Examples 19–23, wherein the delivery tool is configured to displace the device receptacle over a path from a right atrium of the heart, through a tricuspid annulus of the heart, and into a right ventricle of the heart. [0127] Example 25. The medical system of any of Examples 19–24, wherein the implantable medical device comprises a leadless pacemaker. [0128] Example 26. A method, comprising: supporting, using a delivery tool, a device receptacle defining a receptacle volume configured to receive at least a portion of an implantable medical device, wherein the delivery tool defines a delivery lumen and a delivery lumen opening which opens into the receptacle volume; transitioning, using a bending force acting on a shapeable body of the delivery tool, the shapeable body from a first configuration defining a first curvature to a second configuration defining a second curvature different from the first curvature, wherein the device receptacle and the shapeable body are configured to insert within one or more anatomical volumes of a patient; and retaining, using the shapeable body, the shapeable body is in the second configuration when the bending force ceases to act on the shapeable body. [0129] Example 27. The method of Example 26, further comprising: supporting the device receptacle using a shapeable distal portion of the shapeable body; and supporting the shapeable distal portion using a shapeable proximal portion of the shapeable body. [0130] Example 28. The method of claim 27, wherein transitioning the shapeable portion from the first configuration to the second configuration comprises transitioning, using the bending force, a first portion of the shapeable body from the first configuration to the second configuration, wherein the first portion of the shapeable body is one of the shapeable distal portion or the shapeable proximal portion, and further comprising:
Atty Ref. No: A0011315WO01 transitioning, using a second bending force, a second portion of the shapeable body from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature, wherein the second portion of the shapeable body is the other of the shapeable distal portion or the shapeable proximal portion. [0131] Example 29. The method of Example 28, further comprising: defining, using the shapeable distal portion, the second curvature in a first plane of curvature; and defining, using the shapeable proximal portion, the fourth curvature in a second plane of curvature different from the first plane of curvature. [0132] Example 30. The method of any of Examples 26–29, further comprising: defining, using the device receptacle, a receptacle volume shape of a receptacle boundary bounding the receptacle volume; and maintaining, using the device receptacle, the receptacle volume shape when the shapeable body transitions from the first configuration to the second configuration. [0133] Example 31. The method of any of Examples 26–30, further comprising retaining, using a surface of the shapeable body which surrounds and faces away from the delivery lumen, a mark of biocompatible ink from a medical marking device. [0134] Example 32. The method of any of Examples 26–31, further comprising defining, using an outer surface of the shapeable body which surrounds and faces away from the delivery lumen, one or more markings on the outer surface, wherein each marking defines a distance along the outer surface from the each marking to a reference point on the device receptacle. [0135] Example 33. The method of Example 32, further comprising defining, using the outer surface, a first zone exhibiting a first visual aspect and a second zone exhibiting a second visual aspect different from the first visual aspect, wherein the first zone extends distal to a marker of the one or more markers, and where the second zone extends proximal to the marker of the one or more marker. [0136] Example 34. The method of any of Examples 31–33, further comprising representing, using at least one of the mark of biocompatible ink or the one or more markers, a distance defined between a first anatomical structure of a patient and a second anatomical structure of the patient. [0137] Example 35. The method of any of Examples 26–34, further comprising displacing, using the shapeable body, the device receptacle over a path from a right atrium
Atty Ref. No: A0011315WO01 of a heart, through a tricuspid annulus of the heart, and into a right ventricle of the heart. [0138] Example 36. The method of any of Examples 26–35, further comprising delivering, using the delivery tool, the implantable medical device to at least one of a right ventricle of a heart of the patient, a right atrium of the heart of the patient, a left ventricle of the heart of the patient, a left atrium of the heart of the patient, another anatomical volume of the heart of the patient, or another anatomical volume of the patient. [0139] Example 37. The method of any of Examples 26–36, wherein the implantable medical device comprises a leadless pacemaker.