Delivery and retrieval system for medical devices

Abstract

A medical system (120) includes a delivery tool (106) that supports a device receiver (108) configured to hold an implantable medical device (IMD) (102) within a receiver volume. The device receiver is configured to position the IMD within an anatomical volume of a patient, such as a cardiac chamber. The delivery tool includes a malleable portion configured to change from a first configuration defining a first curvature to a second configuration defining a second curvature in response to a bending force. The malleable portion is configured to maintain the second configuration when the bending force ceases to act on the malleable portion. The malleable portion may be configured to define and retain a plurality of bends above a plurality of planes of curvature.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 620,012, filed January 11, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to systems for delivering and / or retrieving implantable medical devices. Background Technology

[0003] Various types of implantable medical devices have been implanted for the treatment or monitoring of one or more conditions in a patient. These implantable medical devices may be adapted to allow the medical device to monitor and / or treat conditions or functions related to the heart, muscles, nerves, brain, stomach, endocrine organs, or other organs and their associated functions. Implantable medical devices may be implanted at target sites selected to detect a patient's physiological condition and / or deliver one or more therapies. For example, an implantable medical device may be delivered to a location in the atrium or ventricle of the heart to sense intrinsic cardiac signals and deliver pacing or anti-tachyarrhythmic shock therapy.

[0004] Some implantable medical devices are sized to be fully implanted within a chamber of the heart and / or another anatomical volume of the patient to detect physiological conditions and / or deliver one or more therapies. Such implantable medical devices may utilize delivery and / or retrieval systems to allow clinicians to navigate (e.g., across the patient's vascular system) the implantable medical device to a target location and / or retrieve it from the patient. In some examples, the implantable medical device may include one or more anchoring components designed to engage with tissue at the target location (e.g., for implantation) and / or disengage from tissue at the target location (e.g., for retrieval). Summary of the Invention

[0005] This disclosure describes a medical system configured to deliver, position, retrieve, and / or otherwise reorient an implantable medical device (“IMD”) within an anatomical volume (e.g., a chamber of the heart) within a patient. The medical system includes a delivery tool that serves as a delivery catheter support device receiver, the receiver being configured to hold the IMD within the receiver volume. The delivery tool includes a malleable portion configured to define and maintain one or more curvatures in response to (e.g., by a clinician) one or more bending forces applied to the malleable portion. Thus, the delivery tool can be configured to allow a clinician to define and maintain one or more curvatures within the patient (e.g., within the patient’s heart) based on a delivery path observed, visualized, and / or otherwise assessed by the clinician prior to delivery of the IMD using the delivery tool.

[0006] In one example, a medical system includes: a device receiver defining a receiver volume configured to receive at least a portion of an implantable medical device; and a delivery tool supporting the device receiver, wherein the delivery tool includes a malleable body configured to change 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 is applied to the malleable body, wherein the malleable body is configured to maintain the second configuration when the first bending force ceases to act on the malleable body, wherein the delivery tool defines a delivery lumen extending through the malleable body and a delivery lumen opening into the receiver volume, and wherein the device receiver and the malleable body are configured to be inserted into one or more anatomical volumes of a patient.

[0007] In one example, a medical system includes: a device receiver defining a receiver volume, a receiver opening, and a receiver axis, the receiver volume being configured to receive at least a portion of an implantable medical device, the receiver opening opening opening into the receiver volume, and the receiver axis extending from a delivery lumen opening to the receiver opening; and a delivery tool supporting the device receiver, wherein the delivery tool defines a delivery lumen and a delivery lumen opening opening into the receiver volume, wherein the delivery tool includes a malleable body including a malleable proximal portion and a malleable distal portion, the delivery lumen extending from the malleable proximal portion to the malleable distal portion, and the malleable distal portion supporting the device receiver. The device receiver and the malleable body are configured to be inserted into one or more anatomical volumes of the patient's heart, wherein the malleable body is configured to change 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 is applied to the malleable body, wherein the malleable body is configured to maintain the second configuration when the first bending force ceases to act on the malleable body, wherein the device receiver defines a receiver volume shape of a receiver boundary that defines a receiver volume, and wherein the device receiver is a substantially rigid device that is configured to maintain the receiver volume shape when the malleable body changes from the first configuration to the second configuration.

[0008] In one example, a method includes: using a delivery tool to support a device receiver defining a receiver volume configured to receive at least a portion of an implantable medical device, wherein the delivery tool defines a delivery lumen and an opening leading to the delivery lumen in the receiver volume; using a bending force acting on a malleable body of the delivery tool to transform the malleable 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 receiver and the malleable body are configured to be inserted into one or more anatomical volumes of a patient; and using the malleable body to hold the malleable body in the second configuration when the bending force ceases to act on the malleable body.

[0009] Details of one or more examples are set forth in the accompanying drawings and the following description. Other features, objectives, and advantages will be apparent from the specification, drawings, and claims. Attached Figure Description

[0010] Figure 1 This is a conceptual diagram illustrating an example medical system and device container within the heart.

[0011] Figure 2 These are concept diagrams illustrating delivery tools and example malleable parts within the heart.

[0012] Figure 3 It is a schematic plan view of the malleable portion that defines the first curvature.

[0013] Figure 4 It is limited to the second curvature Figure 3 A plan view of the malleable part.

[0014] Figure 5 yes Figure 3 and Figure 4 A schematic plan view showing that the malleable part has changed from the third curvature to the fourth curvature.

[0015] Figure 6 yes Figure 5 A schematic end view of the malleable portion, illustrating a first curved portion in a first curvature plane and a second curved portion in a second curvature plane.

[0016] Figure 7 It is a schematic diagram of a delivery tool that is limited to multiple paths traversing three-dimensional space.

[0017] Figure 8 It is a schematic plan view of a delivery tool that defines multiple markers.

[0018] Figure 9 It is a schematic floor plan of a delivery vehicle that defines multiple zones.

[0019] Figure 10This is a schematic cross-sectional view of a device holder for an implantable medical device, with the cutting plane parallel to the page cutout.

[0020] Figure 11 An example technique for using a delivery tool to support a device container is illustrated. Detailed Implementation

[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 the heart) within a patient's body. The delivery tool support is configured to hold a device receptacle of the IMD and a malleable portion configured to define one or more bends. The malleable portion is configured to define one or more bends in response to a bending force applied to it (e.g., by a clinician). In some examples, the malleable portion includes one or more elongated bodies configured to apply a bending force to the malleable portion. For example, the elongated bodies may be configured to apply a bending force to the malleable portion in response to a thrust or pull force applied to them (e.g., by a clinician). The malleable portion is configured to retain one or more bends in the absence of a bending force (e.g., when the clinician stops applying the bending force). Therefore, the delivery tool can be configured to allow clinicians to define and maintain one or more bends within the patient (e.g., within the patient's heart) based on the delivery path 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 bends by the malleable portion can facilitate delivery of the IMD over a delivery path observed, visualized, and / or otherwise assessed by the clinician. For example, during open-heart surgery, when the clinician has direct access to the heart, they can observe, visualize, and / or otherwise assess the delivery path that might be desired when the delivery tool delivers the IMD to the target site within the heart. The clinician can observe, visualize, and / or otherwise assess delivery paths, such as those through the right atrium of the heart, through the tricuspid valve, and into the right ventricle (RV), which may be desired for positioning the device receiver and / or IMD near the target site. The delivery tool is configured to allow the clinician to manipulate the malleable portion to define and retain one or more bends based on the observed, visualized, and / or otherwise assessed delivery path, thereby facilitating the delivery of the IMD across the heart to the target site.

[0023] The malleable body extends from a proximal end (“proximal end of malleable body”) to a distal end (“distal end of malleable body”). A delivery tool defines a delivery lumen that extends at least from the proximal end of the malleable body to the distal end of the malleable body and leads into a receiver volume defined by a device receiver. The medical system may include a delivery system configured to extend through the delivery lumen and engage and / or disengage with the IMD when it is positioned within the receiver volume. The delivery system is configured to move within the delivery lumen and relative to the malleable portion (e.g., proximal translation, distal translation, and / or rotation) to induce movement of the IMD within the receiver volume.

[0024] The malleable portion is configured to allow a clinician to bend and / or flex the malleable portion to define a shape that facilitates or assists in the delivery of the device receiver toward a target site and / or in placing the device receiver 108 near the target site. The malleable portion is configured to define and retain multiple bends (e.g., by clinician manipulation) to allow the delivery tool to define a variety of paths through three-dimensional space. For example, a clinician can define multiple bends extending in planes of different curvatures, such that the malleable portion extends over a first extent in a first spatial dimension, a second extent in a second spatial dimension, and a third extent in a third spatial dimension. Therefore, the delivery tool is configured to allow the clinician to manipulate the malleable portion based on a specific delivery path visualized, observed, and / or otherwise evaluated by the clinician for a given patient. The delivery tool is configured to remain substantially above the specific delivery path visualized for a given patient, maintaining one or more bends caused by clinician manipulation during delivery of the IMD. Therefore, the delivery tool is configured to allow clinicians to place the delivery tool in a patient-specific configuration based on a specific delivery path that is visualized, observed, and / or otherwise assessed for the patient.

[0025] Figure 1This is a conceptual diagram illustrating an example medical system 100 within the right atrium (“RA”) and right ventricle (RV) of a heart 101. The heart 101 is depicted as having a cross-section with a cutting plane parallel to the page. The medical system 100 is configured to deliver and / or retrieve an implantable medical device 102 (“IMD 102”) to and / or from a target site 104 of the heart 101. The medical system 100 includes a delivery tool 106 that supports a device receiver 108. The device receiver 108 is configured to hold the IMD 102 during delivery, deployment, and / or retrieval. The device receiver 108 includes a wall 113 (“receiver wall 113”) defining a receiver volume 112 configured to hold and / or support the IMD 102 during delivery, deployment, and / or retrieval. In each example, IMD 102 includes an attachment member 132 configured to engage tissue within the target site 104. Figure 1 In this context, the container wall 113 is depicted as transparent, although this is not required. In various examples, delivery of the IMD 102 via the medical system 100 may be performed with the IMD 102 "pre-loaded" or present within the device container 108 during the advancement of the delivery catheter 106 into the anatomical volume.

[0026] The device container 108 (e.g., container wall 113) may define a container opening (e.g., container opening 111) leading to the container volume 112. Figure 10 The receiver opening 111 may be, for example, at the distal end 110 of the receiver 108 (“receiver distal end 110”). Although the IMD 102 and the attachment member 132 are in Figure 1 The container is depicted as extending distally to the container opening 111 (e.g., as may occur during implantation of the IMD 102), but the container volume 112 may be configured such that the IMD 102 and / or attachment member 132 are proximal to the container opening 111 (e.g., as may be desired during delivery of the IMD 102 to the target site 104).

[0027] exist Figure 1In this embodiment, IMD 102 is illustrated as being partially positioned within a receiver volume 112 and extending through a receiver opening 111. The receiver opening 111 may be configured to allow at least IMD 102 to pass through it. For example, the receiver opening 111 may be configured to allow IMD 102 to transfer in a distal direction D from its position within the receiver volume 112 to a position distal to the distal end 110 of the receiver. The receiver opening 111 may also be configured to allow IMD 102 to transfer in a proximal direction P from its position distal to the distal end 110 of the receiver to its position within the receiver volume 112. In various examples, the medical system 100 is configured to deploy IMD 102 from a device receiver 108 (e.g., from its position within the receiver volume 112) and through the receiver opening 111 to engage tissue at or near a target site 104. In various examples, the medical system 100 is configured to disengage the IMD 102 from the tissue within the target site 104, for example, to retrieve the IMD 102 from the heart 101 and / or to reposition the IMD 102 within the heart.

[0028] Delivery tool 106 is configured to deliver device receiver 108 and / or IMD 102 to a patient's anatomical volume (e.g., a chamber of heart 101, such as the 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 into the patient's anatomical volume via a surrounding tubular member (not shown) (such as a sheath or guide tool) that may place its distal end in the anatomical volume before delivery tool 106 is advanced through the surrounding tubular member. In various examples, delivery tool 106 is configured to retrieve device receiver 108 and / or IMD 102 from the patient's anatomical volume.

[0029] The delivery tool 106 includes a body 107 (“tool body 107”) that defines a lumen 118 (“delivery lumen 118”) leading into a receiver volume 112. The delivery tool 106 (e.g., tool body 107) may include a distal portion 114 (“delivery tool distal portion 114”) configured to be positioned within the patient and / or intracardiac region of the heart 101. The delivery tool 106 (e.g., tool body 107) may include a proximal portion 116 (“delivery tool proximal portion 116”) configured to be positioned outside the patient and / or extracardiac region of the heart 101 (e.g., outside the chambers of the heart 101) when the delivery tool distal portion 114 is positioned within the patient and / or intracardiac region of the heart 101. In various examples, the delivery tool distal portion 114 supports a device receiver 108 (e.g., is attached to the device receiver and / or substantially integral with the device receiver).

[0030] In various examples, the medical system 100 includes a delivery system 120 configured to engage the IMD 102 when, for example, the IMD 102 is positioned within the receptacle volume 112. The delivery system 120 includes a delivery system body 122, which may include a distal portion 124 (“delivery system body distal portion 124”) and a proximal portion 126 (“delivery system body proximal portion 126”), the distal portion being embodied in a patient and the proximal portion being embodied in a patient. In various examples, the delivery system 120 includes a head portion 128 configured to engage the IMD 102. At least the delivery system body 122 may be configured to slidably translate and / or rotate (e.g., translate and / or rotate relative to the delivery tool 106) within a delivery lumen 118. The delivery system 120 may be configured such that translation and / or rotation of the delivery system body 122 causes the delivery system body 122 and / or head portion 128 to apply translational and / or rotational forces to the IMD 102, such that the IMD 102 translates and / or rotates relative to the container wall 113. For example, the delivery system 120 may be configured to translate within the delivery lumen 118 to (e.g., via the head portion 128) apply a translational force to the IMD 102, thereby causing the IMD 102 to translate relative to the container wall 113 (e.g., within the container volume 112) in a proximal direction P or a distal direction D. The delivery system 120 can be configured to rotate within a delivery lumen 118 to apply a rotational force to the IMD 102 (e.g., via the head portion 128), causing the IMD 102 (e.g., within the receiver volume 112) to rotate about a longitudinal axis L defined by the delivery tool 106 and / or a device axis LD defined by the IMD 102. In some examples, the head portion 128 and the delivery system body 122 can be substantially separate components. In some examples, the head portion 128 can be substantially continuous with the delivery system body 122, such that the head portion 128 and the delivery system body 122 define an integral component. Figure 1 In the image, dashed lines are used to depict the various parts of the delivery system body 122 and / or head portion 128 located within the delivery lumen 118 and / or the container volume 112.

[0031] Delivery system 120 can be used, for example, to advance IMD 102 distally through receptacle opening 111 from device receptacle 108 to deploy IMD 102 into the anatomical volume. Delivery system 120 can also be used, for example, to withdraw IMD 102 from the anatomical volume and / or retract it back into device receptacle 108 through receptacle opening 111. Delivery system 120 and / or its components (such as delivery system body 122) may include any suitable conduit or elongated member, or internal member (e.g., relative to delivery tool 106). Delivery system 120 and / or delivery system body 122 and / or head portion 128 may have sufficient column strength or "pushability" to advance IMD 102 distally from device receptacle 108, for example, during deployment, and / or in some embodiments, to advance IMD 102 or delivery system 120 (without IMD 102 attached thereto) itself along the length of delivery tool 106, which includes its proximal portion 116 and distal portion 114. The delivery system 120, delivery system body 122, and / or head portion 128 may have sufficient tensile strength to extract and / or retract the IMD 102 from the anatomical volume through the receiver opening 111 into the device receiver 108, and / or, in some embodiments, through the length of the delivery tool 106, which includes its proximal delivery system portion 126 and distal delivery system body portion 124. The delivery system 120, delivery system body 122, and / or head portion 128 may have sufficient torque transmission capacity to screw the IMD 102 into and / or out of the target tissue in the anatomical volume. This capability is not required when the IMD 102 is attached to the target tissue without tightening or rotation (e.g., when the IMD 102 is secured via one or more teeth), or when other components perform the screwing-in and / or screwing-out function.

[0032] The container wall 113 may be configured to allow a clinician to determine the location of the IMD 102 when it is within the container volume 112. In various examples, the container wall 113 is configured to provide visual indications of the location of the IMD 102 within the container volume 112. When the device container 108 is observable by a clinician (e.g., prior to a procedure, during a cardiac open-heart procedure, or at another time), the visual indications may assist the clinician during the deployment of the IMD 102 using the delivery tool 106. For example (e.g., during a cardiac open-heart procedure), the container wall 113 may be configured to provide visual indications of the location of the IMD 102 within the container volume 112 to allow the clinician to assess the possible location of the IMD 102 within the heart 101 (e.g., relative to the TV) before deploying the IMD 102 from the device container 108. In various examples, at least a portion of the receiver wall 113 is transparent, such that at least a portion of the IMD 102 is visible when the IMD 102 is positioned within the device receiver 108. In various examples, at least a portion of the receiver wall 113 defines a window (e.g., an opening other than the receiver opening 111) through which at least a portion of the IMD 102 is visible when the IMD 102 is positioned within the device receiver 108. In some examples, the outer surface defined by the receiver wall 113 may include a mark M1 corresponding to the positioning of the IMD 102 within the device receiver 108. For example, when the IMD 102 is loaded into the device receiver 108, the mark M1 may correspond to the intended positioning of a portion of the IMD 102 (e.g., a proximal end or some other portion) within the device receiver 108.

[0033] IMD 102 may include an attachment member 132 configured to engage tissue within target site 104. In some examples, attachment member 132 defines one or more fangs or other structures configured to engage tissue within target site 104 when force is applied to IMD 102 (e.g., force in the distal direction D). Medical system 100 (e.g., delivery system body 122 and / or head portion 128) may be configured to apply force to IMD 102 to engage tissue (e.g., tissue within target site 104) with attachment member 132. In various examples, delivery system body 122 is configured to receive (e.g., from a clinician) force and (e.g., via head portion 128 or another portion of delivery system 120) transfer the force to IMD 102. Attachment member 132 may be configured to disengage from tissue of target site 104 when force in the proximal direction P is applied to IMD 102. In some examples, the attachment member 132 defines a helix or other structure configured to engage tissue within the target site 104 when torque is applied to the IMD 102 (e.g., torque about the longitudinal axis L). The medical system 100 (e.g., the delivery system body 122 and / or head portion 128) may be configured to apply torque to the IMD 102 to engage the attachment member 132 with tissue (e.g., tissue within the target site 104). In various examples, the delivery system body 122 is configured to receive torque (e.g., from a clinician) and transfer torque to the IMD 102 (e.g., via the head portion 128 or another portion of the delivery system 120). In some examples, the attachment member 132 is configured to disengage from the tissue of the target site 104 when a second torque in the opposite direction to the torque causing engagement is applied to the IMD 102.

[0034] Delivery tool 106 is configured (e.g., under the influence of a clinician) to position device receiver 108 and IMD 102 near target site 104. In some examples, such as during open-heart surgery, delivery tool 106 is configured to deliver and / or retrieve device receiver 108 and / or IMD 102 via a pathway 133 formed by the clinician during a surgical procedure (e.g., atrial incision) into the heart 101. For example, the clinician may form pathway 133 substantially through the outer wall of the heart 101 during a surgical procedure (such as an open-heart procedure or another surgical procedure). Delivery tool 106 may be configured to deliver device receiver 108 (e.g., via pathway 133) through the RA of the heart 101, through the tricuspid valve TV of the heart 101, and into the RV of the heart 101 to position device receiver 108 and / or IMD 102 near a target site (such as target site 104). In each example, target site 104 is a site in the lower middle septum (“SW”) of the RV.

[0035] In other examples, delivery tool 106 may be configured to position device receptacles 108 and / or IMDs 102 (e.g., attachment members 132) near and / or in contact with target sites located elsewhere within the heart 101 and / or within other anatomical volumes of the patient. In some examples, delivery tool 106 is configured to use the patient’s vascular system (such as an IVC or other vascular system leading to an anatomical volume) to deliver and / or retrieve device receptacles 108 and / or IMDs 102.

[0036] Delivery tool 106 includes a malleable body 134 configured to be flexible (e.g., bendable by a clinician) to facilitate delivery of the delivery tool 106 through one or more anatomical volumes defined by a patient. A delivery lumen 118 extends through the malleable body 134. In some examples, the malleable body 134 includes a portion of the tool body 107. In some examples, the malleable body 134 includes substantially the entire tool body 107. The malleable body 134 extends from a proximal end 140 (“proximal end 140”) of the malleable body 134 to a distal end 142 (“distal end 142”) of the malleable body 134. In various examples (e.g., when the malleable body 134 includes substantially the entire tool body 107), the proximal end 140 defines a proximal end of the tool body 107 and / or the distal end 142 defines a distal end of the tool body 107. In various examples, the delivery tool 106 is defined in length from about 6 inches to about 14 inches (e.g., from the proximal end 140 of the malleable body to the distal end 110 of the receiver), and in some examples, in length from about 8 inches to about 12 inches. In other examples, the delivery tool 106 may be defined in other lengths (e.g., from the proximal end 140 of the malleable body to the distal end 110 of the receiver).

[0037] The malleable body 134 is configured to define one or more bends in response to bending (e.g., by a clinician). The malleable body 134 is configured to retain one or more bends caused by bending as the delivery tool 106 is transported through one or more anatomical volumes. For example, the malleable body 134 may define a first bend CV1 and / or a second bend CV2 (e.g., by a bending force applied by a clinician) to facilitate the transport of the delivery tool 106 (e.g., transport through the RA, TV, into the RV, and into the vicinity of the target site 104 of the heart 101). The delivery tool 106 (e.g., the malleable body 134) is configured to retain the first bend CV1 and / or the second bend CV2 during transport of the delivery tool 106.

[0038] The retention of the curved portion by the malleable body 134 allows the delivery tool 106 to substantially mimic a specific delivery path that is desired for placing the device receiver 108 and / or 102 near the target site 104 within the patient's body, and / or to minimize the possibility of interference with other anatomical structures (e.g., TV) during delivery. For example, the specific delivery path may be a path visualized, observed, and / or otherwise assessed by a clinician for placing the device receiver 108 and / or 102 near the target site 104. The delivery tool 106 is configured such that a clinician can apply a bending force to the malleable body 134 to generate, for example, curved portions CV1 and / or CV2, such that the delivery tool 106 substantially mimics the specific delivery path visualized, observed, and / or otherwise assessed. The delivery tool 106 (e.g., a malleable body 134) is configured to retain a bend (e.g., bend CV1 and / or bend CV2) generated by the clinician when the clinician delivers the delivery tool 106 toward the target site 104 (e.g., via passage 133).

[0039] For example, Figure 2 The illustration schematically depicts the delivery tool 106 and the heart 101 prior to insertion of the delivery tool 106 (e.g., via passage 133) into the patient's heart 101. For example, during open-heart surgery on the heart 101, a situation similar to [the one described above] might exist when the clinician may have a relatively unobstructed view of the heart 101. Figure 2 The clinician can visualize, observe, and / or otherwise assess the desired delivery path of the delivery tool 106 through the patient's heart 101. The clinician can bend and shape the body 134 (e.g., to define bends CV1 and / or CV2) such that the delivery tool 106 substantially mimics the visualized, observed, and / or otherwise assessed delivery path for the patient. The delivery tool 106 is configured to retain the clinician-generated bends as the delivery tool 106 is transferred toward the target site 104 (e.g., via pathway 133) to facilitate, for example, delivery of IMD 102 to the target site 104 within the patient's body.

[0040] The malleable body 134 is configured such that the first bend CV1, the second bend CV2, or other bends can be defined (e.g., by a bending force applied by a clinician) at any of a variety of locations on the malleable body 134. The malleable body 134 can be configured such that the first bend CV1, the second bend CV2, or another bend can define any curvature angle within a range of curvature angles. The malleable body 134 can be configured such that the bend CV1, the bend CV2, and / or other bends can (e.g., in response to one or more bending forces applied by a clinician) be located at a patient-specific position and utilize patient-specific curvature, such that the delivery tool 106 substantially simulates a delivery path visualized, observed, and / or otherwise assessed for a specific patient. Furthermore, the malleable body 134 can be configured such that a first curved portion CV1 extends through a first plane of curvature, a second curved portion CV2 extends through a second plane of curvature different from the first plane of curvature, and curved portions defined by the malleable body 134 extend through corresponding planes of curvature different from the first and second planes of curvature. Thus, the malleable body 134 can be configured (e.g., in response to bending forces) to define a plurality of curved portions to substantially mimic a wide variety of delivery paths, depending on the specific delivery path visualized, observed, and / or otherwise assessed by a clinician for a given patient.

[0041] For example, the malleable body 134 can be configured to define a variety of paths through three-dimensional space as it extends from the proximal end 140 to the distal end 142. The malleable body 134 can be configured to define the path from the proximal end 140 to the distal end 142 using a first bend CV1, a second bend CV2, and / or other bends caused by applying a bending force (e.g., by a clinician) to the malleable body 134. Thus, the malleable body 134 is configured such that a clinician can visualize, observe, and / or otherwise assess a particular delivery path for a given patient, and apply a bending force to define a path from the proximal end 140 to the distal end 142 that substantially mimics a particular delivery path.

[0042] although Figure 2The scenario depicts a relatively unobstructed view of the heart 101, but this is not necessary for the use of the delivery tool 106. The delivery tool 106 can be used in minimally invasive cardiac procedures or other procedures for delivering medical devices (such as IMD 102) to the anatomical volume of a patient. The clinician can bend and shape the body 134 so that the delivery tool 106 substantially mimics the visualized, observed, and / or otherwise evaluated transport path for minimally invasive cardiac procedures or other procedures for delivering medical devices.

[0043] In some examples, the malleable body 134 includes one or more rigid portions configured to act as locations for applying bending forces, such as minimizing bending forces applied to certain portions of the delivery tool 106 (e.g., the device receiver 108). The rigid portions may be configured to maintain their shape when bending forces are applied to them, or configured (e.g., elastically biased) to return to their initial shape prior to application when the bending forces cease acting on them. In various examples, the rigid portion of the malleable body 134 is a portion of the malleable body 134 substantially located between the proximal end 140 and the distal end 142 of the malleable body. In some examples, the rigid portion defines either the proximal end 140 or the distal end 142 of the malleable body. The rigid portion may be configured to cause another portion of the malleable body 134 to change its curvature (e.g., to define a first bend CV1 or a second bend CV2) when bending forces are applied to it (e.g., by a clinician). In some examples, the rigid portion is a first portion of the malleable body 134 that is integral with another portion and / or the remainder of the malleable body 134 (e.g., continuous in material). In some examples, the rigid portion defines a substantially rigid layer of the malleable body 134 (e.g., covering a portion of the outer surface 148 of the malleable body or a layer located within the malleable body 134 below the outer surface 148 of the malleable body).

[0044] For example, the malleable body 134 may include a connector 145 ( Figure 1 The connector is configured to connect the malleable body 134 and the device receiver 108. In various examples, the connector 145 is part of the malleable distal portion 144. The connector 145 may be configured to maintain its shape when a bending force is applied to the connector 145, or to return to its initial shape prior to application when the bending force ceases to act on the connector 145. The connector 145 may be located on the malleable body 134 to, for example, prevent the application of bending forces to the device receiver 108, which in some examples may affect the positioning of the IMD 102 within the receiver volume 112.

[0045] In some examples, delivery tool 106 may include a pre-shaped fixed bend configured to assist in delivery of IMD 102 and / or device receiver 108 to target site 104. For example, tool body 107 and / or malleable body 134 may define a fixed bend FC (e.g., a J-shaped bend) configured to assist in delivery of IMD 102. The fixed bend FC may be based on the orientation of device receiver 108 and / or IMD 102 that is expected to be advantageous when medical system 100 uses a particular delivery path to deliver device receiver 108 and / or IMD 102. For example, the fixed bend FC may be configured to generally orient device receiver 108 such that the distal end 110 of the receiver substantially faces the septum (SW) of heart 101 when the particular delivery path defines a path through the TV to the RV.

[0046] In various examples, the delivery tool 106 (e.g., the malleable body 134) includes one or more markings that are observable by a clinician to substantially indicate the location of the device receiver 108 and / or IMD 102 (e.g., within the heart 101) as the delivery tool is transported toward the target site 104. For example, the delivery tool 106 may include a marking M2 on its outer surface 136 (“tool outer surface 136”) that is configured to indicate when the device receiver 108 and / or IMD 102 are near the patient’s first anatomical location and / or structure (e.g., the TV of the heart 101) as the delivery tool 106 is transported toward the target site 104 (e.g., via passage 133). The delivery tool 106 may include a mark M3 on its outer surface 136, configured to indicate when the device receiver 108 and / or IMD 102 are near the target site 104 (e.g., in the second anatomical location and / or structure of the patient, such as the target site 104 in the inferior septum of the heart 101) as the delivery tool 106 (e.g., via passage 133) is delivered to the target site 104. In various examples, the outer surface 136 includes at least a portion of the outer surface defined by the malleable body 134. In various examples, the mark (e.g., mark M2 or mark M3) is configured to define the mark relative to a reference point on the medical system 100 (such as reference point P1 on the device receiver 108 (e.g., the distal end 110 of the receiver)). Figure 2 The distance between the markers. The markers can be configured to allow clinicians to insert the shaped delivery tool 106 into the anatomical volume (e.g., the RA of the heart 101) and to assess the position of the device receiver 108 and / or IMD 102 as the delivery tool 106 is transported toward the target site 104.

[0047] In some examples, the outer surface 136 of the tool is configured to retain a mark, for example, a biocompatible ink delivered by a medical marking device 138. In various examples, the medical marking device 138 is a marker or other device configured to be controlled (e.g., held) by a clinician, allowing the clinician to use the medical marking device 138 to generate one or more marks (such as mark M2 and / or mark M3). Thus, the delivery tool 106 may be configured to allow a clinician to visualize, observe, and / or otherwise evaluate the delivery path of the delivery tool 106 within a particular patient and to generate one or more marks on the outer surface 136 of the tool to assess the position of the device receiver 108 and / or IMD 102 as the delivery tool 106 is delivered toward a target site 104 within the particular patient (e.g., when the delivery tool 106 substantially mimics a delivery path visualized, observed, and / or otherwise evaluated for the particular patient).

[0048] In some examples, one or more markings on the outer surface 136 of the tool may be pre-marked, substantially permanent markings. For example, markings M2, M3 may be pre-marked on the malleable body 134 to indicate representative distances along the outer surface 136 of the tool, indicating when the device receiver 108 and / or IMD 102 is near a specific anatomical location and / or structure of a representative patient. Markings M2, M3 may be positioned to allow clinicians to insert the malleable delivery tool 106 into the anatomical volume of a given patient undergoing the procedure and to assess the position of the device receiver 108 and / or IMD 102 within the patient based on the representative distance defined by the pre-marked, substantially permanent markings.

[0049] In some examples, the outer surface 136 of the tool defines a first region and a second region, the first region exhibiting a first visual aspect and the second region exhibiting a second visual aspect different from the first visual aspect. For example, the first region may extend distally to a marker (e.g., marker M2 or marker M3), and the second region may extend proximally to a marker (e.g., marker M2 or marker M3). The first visual aspect may be, for example, a first color of the outer surface 136, a first pattern on and / or defined by the outer surface 136, and / or another first visual mark of the outer surface 136. The second visual aspect may be, for example, a second color of the outer surface 136, a second pattern on and / or defined by the outer surface 136, or at least one other visual aspect of the outer surface 136 that is visually different from the first visual aspect. In some examples, the region (e.g., the first region or the second region) may extend between marker M2 and marker M3. When the delivery tool 106 is moved toward the target site 104, the first and second zones can help clinicians more efficiently assess the position of the device container 108 and / or IMD 102.

[0050] In various examples, delivery tool 106 is configured (e.g., to a clinician) to provide indication of the rotational orientation of the malleable body 134 and / or device receiver 108 (e.g., rotational orientation relative to the RA, RV, TV, or another part of the heart 101). Delivery tool 106 may be configured (e.g., to a clinician) to provide indication of the degree of rotation of the malleable body 134 and / or device receiver 108 (e.g., the degree of rotation about the longitudinal axis L). For example, delivery tool 106 may include a mark M4 (e.g., on the outer surface 136 of the tool) indicating the rotational orientation of the malleable body 134 and / or device receiver 108 relative to the RA, RV, TV, or another part of the heart 101. Mark M4 may be configured to rotate about the longitudinal axis L as the malleable body 134 and / or device receiver 108 rotates about the longitudinal axis L, such that the rotational displacement of mark M4 indicates the rotation of the malleable body 134 and / or device receiver 108. In each example, the mark M4 is a substantially permanent mark on the outer surface 148 of the malleable body and / or the outer surface 136 of the tool. The mark M4 may have any length and may extend over any length of the delivery tool 106. For example, the mark M4 may extend over a portion of the length of the malleable body 134 or substantially over the entire length of the malleable body.

[0051] In various examples, the malleable body 134 includes a distal portion 144 (“malleable distal portion 144”) and a proximal portion 146 (“malleable proximal portion 146”). The tool body 107 may define the malleable distal portion 144 and the malleable proximal portion 146. In various examples, the malleable distal portion 144 supports (e.g., mechanically coupled to) a device receiver 108. The delivery tool 106 may be configured such that a delivery lumen 118 extends through the malleable proximal portion 146 and the malleable distal portion 144. In various examples, the malleable body 134 is configured such that when the malleable proximal portion 146 defines and holds a second bend (e.g., bend CV2) or a second plurality of bends, the malleable distal portion 144 may define and hold a first bend (e.g., bend CV1) or a first plurality of bends. In various examples, the malleable body 134 includes at least a portion of the delivery tool distal portion 114. In each example, the marker M4 extends substantially from the proximal malleable portion 146 to the distal malleable portion 144.

[0052] Therefore, the medical system 100 can be configured to facilitate the delivery of the delivery tool 106, device receiver 108, and / or IMD 102 through one or more anatomical volumes defined by the patient en route to the target site 104. In various examples, the medical system 100 is configured to substantially mimic a specific delivery path within the patient's body as visualized, observed, and / or otherwise assessed by a clinician. The delivery tool 106 includes a malleable body 134 configured to be flexible (e.g., by a clinician) to define one or more bends to substantially mimic the specific delivery path. The malleable body 134 is configured to retain one or more bends as the delivery tool 106 is delivered through (e.g., by a clinician) 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 the IMD 102 in a manner similar to that described for the RV of heart 101, in any other chamber of heart 101 and / or in other anatomical volumes of the patient. Furthermore, although the examples herein discuss target site 104 as a target site substantially on or within the inferior septum of heart 101, medical system 100 may be configured to deliver device receiver 108 and / or IMD 102 to the vicinity of the target site in any part of heart 101, and may be configured to retrieve IMD 102 from any part of heart 101. Additionally, although the examples herein discuss delivery of delivery tool 106 via passage 133, delivery tool 106 may be delivered via other passages, including passages naturally defined by the patient and passages naturally formed by the patient's body.

[0054] Figure 3 This is a schematic plan view of a medical system 100 including a malleable body 134 in a first configuration. In the first configuration, the malleable body 134 (e.g., malleable distal portion 144) defines a first curvature C1 that is substantially zero (e.g., the malleable distal portion 144 is substantially straight). Figure 4 This is a schematic plan view of a medical system 100 having a malleable body 134 in a second configuration. In the second configuration, the malleable body 134 (e.g., a malleable distal portion 144) defines a second curvature C2 different from the first curvature C1. Figure 5 This is a schematic plan view of a medical system 100 having a malleable body 134 (e.g., a malleable proximal portion 146), which has been defined from... Figure 3 and Figure 4 The third curvature C3 is transformed into a defined fourth curvature C4. In Figure 3 and Figure 4In the middle, the third curvature C3 is essentially zero (e.g., the malleable proximal portion 146 is essentially straight).

[0055] The delivery lumen 118 extends at least from the proximal end 140 of the malleable body to the distal end 142 of the malleable body and leads into the receiving volume 112 of the device receiver 108. In various examples, the delivery tool 106 (e.g., tool body 107) defines a longitudinal axis L extending at least from the proximal end 140 of the malleable body to the distal end 142 of the malleable body. The longitudinal axis L may extend through the delivery lumen 118. In some examples, the longitudinal axis L extends through the receiving volume 112 and the receiving opening 111. The longitudinal axis L (and / or portions thereof) may be linear, curved, and / or wavy, depending on the curvature of the malleable body 134 (or substantially without curvature). As discussed, in some examples, the tool body 107 may extend proximally to the malleable body 134 and the proximal end 140 of the malleable body. In other examples, the malleable body 134 may substantially define the entire tool body 107.

[0056] For example, such as Figure 3 As depicted, when the malleable distal portion 144 defines a first curvature C1 that is substantially zero (e.g., when the malleable distal portion 144 is substantially straight), the first portion of the longitudinal axis L extending through the malleable distal portion 144 can be substantially linear. Figure 4 As depicted, when the malleable distal portion 144 defines a second curvature C2 different from the first curvature C1, the first portion L1 of the longitudinal axis L can be curved. Similarly, when the malleable proximal portion 144 defines a third curvature C3 that is substantially zero (e.g., when the malleable proximal portion 146 is substantially straight), the second portion L2 extending through the longitudinal axis L of the malleable proximal portion 144 can be substantially linear, and when the malleable proximal portion 146 defines a fourth curvature C4 different from the third curvature C3, this second portion can be curved.

[0057] The malleable body 134 defines an outer surface 148 (“Moldable Body Outer Surface 148”) facing away from the longitudinal axis L (e.g., away from the first portion L1 and / or the second portion L2). The malleable body outer surface 148 may extend from the proximal end 140 of the malleable body to the distal end 142 of the malleable body. In various examples, the malleable body outer surface 148 surrounds the longitudinal axis L as it extends from the proximal end 140 to the distal end 142 of the malleable body. In some examples, the malleable body 134 defines an inner surface 150 (“Moldable Body Inner Surface 150”) opposite the malleable body outer surface 148. The malleable body inner surface 150 may be configured to define a delivery lumen 118 between the proximal end 140 and the distal end 142 of the malleable body.

[0058] The malleable body 134 is configured to respond to a bending force F1 applied to the malleable body 134. Figure 4 The malleable body 134 is bent and / or flexed to change its curvature. In various examples, the malleable body 134 is configured to receive a bending force F1 from the clinician to define a curved portion (such as a first curved portion CV1). The malleable body 134 is configured to retain the first curved portion CV1 when the bending force F1 ceases to act on the malleable body 134 (e.g., when the clinician stops applying the bending force F1). In some examples, the malleable body 134 is configured to bend and / or flex in response to a hand force delivered by the clinician, such that the clinician can manipulate the malleable body 134 to define a desired shape to facilitate delivery of the delivery tool 106 over a delivery path visualized, observed, and / or otherwise assessed by the clinician. For example, the malleable body 134 may be configured to bend and / or flex in response to a bending force F1 of less than or equal to about 10 pounds (e.g., delivered by the clinician) to define one or more curved portions (e.g., a first curved portion CV1).

[0059] The malleable body 134 can be configured to receive a bending force F1 in any manner. For example, the malleable body 134 can be configured to receive a bending force F1 by applying a bending force F1 to the outer surface 136 and / or the malleable outer surface 148 of the catheter. The malleable body 134 can be configured such that a clinician can apply a bending force F1 to the outer surface 136 and / or the malleable outer surface 148 of the catheter using, for example, a tool or the fingers of the clinician's hand. In some examples, the malleable body 134 is configured to receive a bending force F1 from a component (e.g., an elongated body) configured to induce a bending force F1. The component can be configured to apply a bending force F1 when a force is applied to the component (e.g., by a clinician). For example, the component can be configured to apply a bending force F1 to the malleable portion 134 in response to a thrust or pull force applied to the component (e.g., by a clinician). In various examples, the component (e.g., an elongated body) is attached to and / or embedded within the delivery body 107 and / or the malleable body 134. The component may be configured to transfer forces (e.g., by a clinician) applied to the component to the delivery body 107 and / or the malleable body 134 to induce a bending force F1 on the delivery body 107 and / or the malleable body 134.

[0060] The malleable body 134 can be configured to bend and / or flex to define a plurality of bends between the proximal end 140 and the distal end 142 of the malleable body. For example, as Figure 5 As depicted, the malleable body 134 can be configured such that when the malleable proximal portion 146 defines the second bend CV2, the malleable distal portion 144 defines the first bend CV1. The malleable proximal portion 146 can be configured to bend and / or flex in response to a second bending force F2 applied to the malleable body 134 (e.g., applied by a clinician to the malleable proximal portion 146) to define the second bend CV2. The malleable body 134 can further bend and / or flex in response to other bending forces applied at other locations (e.g., by a clinician) to define bends other than the first bend CV1 and the second bend CV2. Thus, the delivery tool 106 can be configured to allow a clinician (e.g., by applying bending forces) to manipulate the malleable body 134 to define multiple bends over multiple locations on the malleable body 134, such that the delivery tool 106 defines a desired shape between the proximal end 140 and the distal end 142 of the malleable body.

[0061] In each example, the malleable body 134 is configured to, when the bending force F1 is applied to the malleable body 134, pass through from... Figure 3 The first configuration change to Figure 4The second configuration allows for bending and / or deflection. The malleable body 134 defines a first curvature C1 in the first configuration and a second curvature C2 in the second configuration. As discussed, and as... Figure 3 As depicted, when the first curvature C1 is defined by a substantially straight portion of the malleable body 134, the first curvature C1 can define a curvature that is substantially zero. The second curvature C2 is different from the first curvature C1. Therefore, the malleable body 134 can be configured to bend and / or flex in response to a bending force F1 acting on the malleable body 134, changing the curvature defined by the malleable body 134 from the first curvature C1 to the second curvature C2, such that the malleable body 134 transforms from a first configuration to a second configuration.

[0062] The malleable body 134 is configured to maintain a second configuration (e.g., continue to define a second curvature C2) when the bending force F1 ceases to act on the malleable body 134. For example, when a clinician applies a bending force F1 to the malleable body 134, the malleable body 134 can change from a first configuration defining a first curvature C1 to a second configuration defining a second curvature C2. When the clinician stops applying the bending force F1 to the malleable body 134, the malleable body 134 can continue to define the second curvature C2.

[0063] The malleable body 134 can be configured to change the curvature of its longitudinal axis L when a bending force F1 is applied to it. In various examples, the first curvature C1 and the second curvature C2 can be the curvature of the longitudinal axis L defined relative to a normal vector V1 that is perpendicular to and passes through the longitudinal axis L. The malleable body 134 can be configured to change the curvature of its longitudinal axis L relative to the normal vector V1 when it transitions from a first configuration defining the first curvature C1 to a second configuration defining the curvature C2.

[0064] For example, in some examples, the second curvature C2 may define the curvature of the longitudinal axis L relative to the normal vector V1, which is more positive or more negative than the curvature of the longitudinal axis L relative to the normal vector V1 defined by the first curvature C1. Similarly, the first curvature C1 may define the curvature of the longitudinal axis L relative to the normal vector V1, which is more positive or more negative than the curvature of the longitudinal axis L relative to the normal vector V1 defined by the second curvature C2. Therefore, the malleable body 134 may be configured to change the curvature of the longitudinal axis L (e.g., change it to a more positive or more negative curvature) when the malleable body 134 changes from a first configuration defining the first curvature C1 to a second configuration defining the curvature C2. As an example, the malleable body 134 may change the curvature of the longitudinal axis L from the first curvature C1 to the second curvature C2 so that the malleable proximal portion 146 defines the first curved portion CV1. In some examples, the malleable body 134 is configured such that a first curvature C1 can define a curvature angle greater than about 170 degrees, and a second curvature C2 can define a curvature angle less than about 120 degrees.

[0065] In some examples, as an alternative or supplement to changing the curvature of the longitudinal axis L, the malleable body 134 is configured to change the curvature of the outer surface 148 of the malleable body when a bending force F1 is applied to the malleable body 134. For example, the normal vector V1 may be perpendicular to and pass through the outer surface 148 of the malleable body. The malleable body 134 may be configured to change the curvature of the outer surface 148 of the malleable body relative to the normal vector V1 when the malleable body 134 changes from a first configuration to a second configuration. For example, in some examples, a second curvature C2 may define the curvature of the outer surface 148 of the malleable body relative to the normal vector V1 that is more positive or more negative than the curvature of the outer surface 148 of the malleable body relative to the normal vector V1 defined by the first curvature C1. Similarly, a first curvature C1 can define the curvature of the outer surface 148 of the malleable body relative to the normal vector V1, which is more positive or more negative than the curvature of the outer surface 148 of the malleable body relative to the normal vector V1 defined by a second curvature C2. Therefore, the malleable body 134 can be configured to change the curvature of the outer surface 148 of the malleable body (e.g., change to a more positive or more negative configuration) when the malleable body 134 changes from a first configuration defining the first curvature C1 to a second configuration defining the second curvature C2. The malleable body 134 can change the curvature of the outer surface 148 of the malleable body from the first curvature C1 to the second curvature C2, such that the malleable proximal portion 146 defines the first curved portion CV1.

[0066] The malleable body 134 can be configured to change the curvature of the longitudinal axis L and / or the outer surface 148 of the malleable body relative to the normal vector V2 of the extended longitudinal axis L and / or the outer surface 148 of the malleable body, to define the second bend CV2 in a manner similar to or the same as that described when the malleable body 134 changes the curvature of the longitudinal axis L and / or the outer surface 148 of the malleable body relative to the normal vector V1. For example, the malleable body 134 can be configured to change the curvature of the longitudinal axis L from a third curvature C3 ( Figure 4 ) changed to the fourth curvature C4 ( Figure 5 The malleable proximal portion 146 defines one or more bends (such as a second bend CV2) when the malleable distal portion 144 defines one or more bends (such as a first bend CV1).

[0067] The malleable body 134 can be configured to define a plurality of bends between the proximal end 140 and the distal end 142 of the malleable body, such that the plurality of bends define a plurality of planes of curvature. Therefore, the malleable body 134 can be configured to define a plurality of bends such that the longitudinal axis L defines a path extending through three-dimensional space. For example, Figure 6 It is viewed in the proximal direction (P). Figure 5 A schematic end view of the malleable body 134 and the device receiver 108. The malleable body 134 may be configured to define a first bend CV1 in a first curvature plane PC1 (e.g., such that at least one segment of the first portion L1 lies within the first curvature plane PC1). The malleable body 134 may be configured to define a second bend CV2 in a second curvature plane PC2 (e.g., such that at least one segment of the second portion L2 lies within the second curvature plane PC2). The second curvature plane PC2 is different from the first curvature plane PC1. For example, in some examples (e.g., as...), Figure 6 (As depicted), the second curvature plane PC2 may intersect with the first curvature plane PC1. In some examples, the second curvature plane PC2 may be parallel to the first curvature plane PC1.

[0068] The malleable body 134 can be configured to define additional bends extending through planes of curvature different from the first plane of curvature PC1 and the second plane of curvature PC2. Thus, the malleable body 134 can be configured to define a plurality of bends (e.g., in response to bending forces) that allow the longitudinal axis L to define a path extending through three-dimensional space, to substantially simulate, for example, a transport path visualized, observed, and / or otherwise assessed by a clinician for a given patient.

[0069] For example, Figure 7A delivery tool 106 is depicted defining multiple paths from the proximal end 140 of a malleable body to the distal end 110 of a receiver in a three-dimensional space defined by the x-axis, the y-axis perpendicular to the x-axis, and the z-axis perpendicular to both the x-axis and the y-axis. The proximal end 140 of the malleable body is positioned at the origin G of the three-dimensional space defined by the x-axis, y-axis, and z-axis. In one example, the malleable body 134 defines a first plurality of bends 152 such that the delivery tool 106 defines a first path PT1 from the proximal end 140 of the malleable body to the distal end 110 of the receiver. When the delivery tool 106 defines the first path PT1, the malleable body 134 can pass through a first set of points (C1, C2, C3, ..., CN) defined by the x-axis, y-axis, and z-axis. In another example, the malleable body 134 defines a second plurality of bends 154 such that the delivery tool 106 defines a second path PT2 from the proximal end 140 of the malleable body to the distal end 110 of the receiver. When the delivery tool 106 defines the second path PT2, the malleable body 134 can pass through a second set of points (D1, D2, D3, ..., DN) defined by the x-axis, y-axis, and z-axis. In another example, the malleable body 134 defines a third plurality of bends 156 such that the delivery tool 106 defines a third path PT3 from the proximal end 140 of the malleable body to the distal end 110 of the receiver. When the delivery tool 106 defines the third path PT3, the malleable body 134 can pass through a third set of points (E1, E2, E3, ..., EN) defined by the x-axis, y-axis, and z-axis.

[0070] The malleable body 134 is configured such that the first path PT1, the second path PT2, and the third path PT3 can define different paths traversing 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) that 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) that are not present in the third set of points (E1, E2, E3, ..., EN). In some examples, each of the first path PT1, the second path PT2, the third path PT3, and / or other paths defined by the malleable body 134 defines a set of points that defines a range above the x-axis, a range above the y-axis, and a range above the z-axis, such that the malleable body 134 defines a path traversing three-dimensional space.

[0071] The malleable body 134 is configured to define a first path PT1, a second path PT2, or a third path PT3 in response to a bending force applied to the malleable body 134 (e.g., by a clinician). The malleable body 134 is configured to maintain (e.g., continue to define) the first path PT1, the second path PT2, or the third path PT3 when the bending force ceases to act on the malleable body 134 (e.g., when the clinician stops applying the bending force). Therefore, the malleable body 134 is configured such that the clinician can define a wide variety of paths for the delivery tool 106 based on specific paths observed, visualized, and / or otherwise assessed by the clinician.

[0072] In various examples, the malleable body 134 includes at least one malleable material 158 configured to define one or more bends in response to bending forces F1, F2 acting on the malleable material 158. The malleable material 158 may be configured to retain one or more bends when the bending forces F1, F2 cease acting on the malleable material 158. In various examples, the malleable material 158 is an inelastically deformable material configured to undergo inelastic deformation when the bending forces F1, F2 act on the malleable material 158. For example, the malleable material 158 may be configured to inelasticly deform from an initial shape (e.g., the shape of one of PT1, PT2, or PT3 defined by the malleable body 134) to a subsequent shape (e.g., the shape of another of PT1, PT2, or PT3 defined by the malleable body 134) in response to the bending forces F1, F2 acting on the malleable material 158. The malleable material 158 can be configured to maintain its subsequent shape when the bending forces F1 and F2 cease to act on the malleable material 158.

[0073] In some examples, the malleable body 134 is configured to define a plurality of bends such that the longitudinal axis L defines a path extending through (e.g., confined to) two-dimensional space rather than through three-dimensional space. For example, the malleable body 134 may be configured to define a first bend CV1 substantially in a single plane of curvature, a second bend CV2 substantially in a single plane of curvature, and / or other bends within a single plane of curvature. Furthermore, when the malleable body 134 is configured to define a plurality of bends such that the longitudinal axis L defines a path extending through three-dimensional space, the malleable body 134 may still define the first bend CV1 substantially in a single plane of curvature, the second bend CV2 substantially in a single plane of curvature, and / or other bends within a single plane of curvature.

[0074] In various examples, the malleable body 134 includes a malleable material 158 and one or more additional materials. The malleable material 158 may be configured to, when the malleable material 158 defines one or more bends (e.g., one of a first plurality of bends 152, a second plurality of bends 154, or a third plurality of bends 156), cause at least a portion of the additional material to define one or more bends (e.g., one of a first plurality of bends 152, a second plurality of bends 154, or a third plurality of bends 156). In various examples, the additional material is a bendable, flexible material, such as a flexible tube. For example, the additional material may be configured to flex and / or bend from a first curvature C1 to a second curvature C2 in response to a bending force less than a bending force F1 (e.g., its own weight), such that the additional material flexes and / or bends in response to a bending force less than that of the malleable material 158. The malleable material 158 can be configured such that the additional material maintains the second curvature C2, regardless of other forces acting on the additional material (e.g., gravity, other contact forces).

[0075] The malleable material 158 may include any portion of the malleable body 134. For example, the malleable material 158 may extend from a proximal end 140 of the malleable body to a distal end 142 of the malleable body. In some examples, the malleable material 158 defines at least a portion of the outer surface 148 and / or the inner surface 150 of the malleable body. In some examples, the malleable material 158 defines one of the outer surface 148 or the inner surface 150 of the malleable body, and additional material includes the other of the outer surface 148 or the inner surface 150 of the malleable body. In some examples, the malleable material 158 defines an inner layer or inner body of the malleable body 134. For example, the malleable body 134 may be configured such that additional material defines the outer surface 148 and the inner surface 150 of the malleable body, and the malleable material 158 defines an inner layer between the outer surface 148 and the inner surface 150 of the malleable body. In some examples, the malleable material 158 is essentially an elongated body (e.g., a wire or a thin rod). In some examples, the malleable material 158 is a substantially tubular element configured to surround a longitudinal axis L (e.g., a flexible bellows, a flexible coil, or another substantially tubular element).

[0076] In various examples, the delivery system body 122 and / or the malleable body 134 comprises a polymeric material, such as polyvinyl chloride (PVC) and / or Pebax (available from Arkema SA). In some examples, the malleable material 158 is a wire configured to deform from an initial shape to a subsequent shape and maintain that subsequent shape. The wire may be, for example, stainless steel wire. In various examples, the wire is round-bent shaped multipurpose 304 stainless steel wire (available from McMaster-Carr).

[0077] Figure 8 A schematic plan view of a delivery tool 106 including one or more markings is depicted, the one or more markings being configured to indicate the position of the device receiver 108 and / or IMD 102 relative to the one or more markings. Figure 9 A schematic plan view of a delivery tool 106 is depicted, comprising one or more zones configured to indicate the position of the device receiver 108 and / or IMD 102 relative to the one or more zones. One or more markings and / or one or more zones may be configured to provide visual indications that can be observed by a clinician to assist in assessing the position and / or orientation of the device receiver 108 and / or IMD 102 within the heart 101.

[0078] The markings and / or areas can be configured to define the distance from the markings and / or areas to a reference point on the delivery tool 106 above the outer surface 148 of the malleable body. For example, as Figure 8 As depicted, marker M3 may define a distance S1 above the outer surface 148 of the malleable body, from marker M1 to a reference point P1 on the device receiver 108 (e.g., the distal end 110 of the receiver). Marker M2 may define a distance S2 above the outer surface 148 of the malleable body and / or the outer surface 136 of the tool, from marker M2 to the reference point P1 on the device receiver 108 (e.g., the distal end 110 of the receiver). Similarly, as Figure 9 As depicted, the first region Z1 may define a distance S3 from above the outer surface 148 of the malleable body to a reference point P1 on the device receiver 108, and / or the second region Z2 may define a distance S4 from above the outer surface 148 of the malleable body and / or the outer surface 136 of the tool to a reference point P1 on the device receiver 108 (e.g., the distal end 110 of the receiver). Markers M1, M2, the first region Z1, and / or the second region Z2 may be configured to provide visual indications observable by a clinician to assist in assessing the location of the device receiver 108 and / or the IMD 102 within the heart 101 when the device receiver 108 and / or IMD 102 may have limited visibility to the clinician.

[0079] For example, when the delivery tool 106 is deployed through the pathway 133 of the heart 101, portions of the delivery tool 106 (e.g., the distal malleable portion 144 and / or a portion of the device receiver 108) may have limited visibility to the clinician as the delivery tool 106 is deployed toward the target site 104 (e.g., by a clinician). The delivery tool 106 may be configured such that the clinician can observe the positioning of markers M1, M2, first zone Z1, and / or second zone Z2 relative to, for example, a portion of the pathway 133, to assess the proximity of the device receiver 108 and / or IMD 102 to the target site 104 as the delivery tool 106 is deployed. The delivery tool 106 may be configured such that the clinician can observe changes in the positioning (e.g., displacement) of markers M1, M2, first zone Z1, and / or second zone Z2 as the delivery tool 106 is deployed, to assess, for example, the resulting displacement of the device receiver 108 and / or IMD 102. For example, specific markers or regions (e.g., marker M2 and / or region Z2) may allow clinicians to base their decisions on specific markers or regions relative to pathway 133. Figure 1 The location of the distal end 111 of the receiver is used to assess the proximity of the receiver to the TV. Specific markers or areas (e.g., marker M3 and / or area Z1) allow clinicians to assess the proximity of the distal end 111 of the receiver to the TV based on the location of specific markers or areas relative to the pathway 133. Figure 1 The location of the container is used to assess the proximity of the distal end 111 of the container to the apex of the heart 101.

[0080] Figure 10 This is a schematic plan view of a device holder 108 that holds the IMD 102 within a holder volume 112, wherein the device holder 108, the malleable body 134, and the connector 145 are depicted as having a cross-section with a cut plane taken parallel to the page (e.g., parallel to the longitudinal axis L).

[0081] Container wall 113 defines container volume 112. In various examples, container wall 113 includes a body 160 (“wall body 160”) defining an inner wall surface 162. The inner wall surface 162 may define at least a portion of a boundary that defines container volume 112. In various examples, the inner wall surface 162 at least partially and / or substantially completely surrounds the longitudinal axis L. In various examples, wall body 160 defines container opening 111. Wall body 160 may define container opening 111 substantially at the distal end 110 of the container. Container opening 111 may be configured such that IMD 102 can exit from within container volume 112 through container opening 111 (e.g., in the distal direction D) and / or enter container volume 112 through container opening 111 (e.g., in the proximal direction P). In each example, when the IMD 102 is positioned within the container volume 112, the device axis LD defined by the IMD 102 extends through at least a portion of the container volume 112 and through the container opening 111. In each example, the container volume 112 is at least partially defined by the container opening 111.

[0082] The wall body 160 may define an outer wall surface 164. In various examples, at least a portion of the wall body 160 is located between the outer wall surface 164 and the inner wall surface 162. In various examples, the outer wall surface 164 at least partially and / or substantially completely surrounds the longitudinal axis L and / or the inner wall surface 162. The outer wall surface 164 may be configured such that the outer wall surface 164 is substantially oriented away from the longitudinal axis L, the inner wall surface 162, and / or the container volume 112.

[0083] In various examples, delivery tool 106 (e.g., malleable distal portion 144) defines a lumen opening 166 (“delivery lumen opening 166”) of delivery lumen 118 that opens into receiver volume 112. Delivery lumen opening 166 is configured to allow at least some portion of delivery system body 122 to be positioned within receiver volume 112 when another portion of delivery system body 122 is positioned within delivery lumen 118. In various examples, a longitudinal axis L extends through delivery lumen opening 166. Receiver volume 112 may be at least partially defined by delivery lumen opening 166. In various examples, receiver volume 112 is at least partially defined by delivery lumen opening 166, receiver opening 111, and at least some portion of inner wall surface 162. In some examples, receiver volume 112 defines a cross-sectional region perpendicular to longitudinal axis L, wherein the cross-sectional region is defined by a curved, curved, or polygonal boundary. In some examples, the cross-sectional region is defined by a substantially circular boundary.

[0084] In various examples, the device receiver 108 is a substantially rigid and / or substantially elastically deformable member, configured to maintain its shape when the malleable body 134 defines one or more bends (e.g., a first bend CV1 and / or a second bend CV2). The device receiver 108 may be configured to maintain its shape when the malleable body 134 transitions from a first configuration defining a first curvature C1 to a second configuration defining a curvature C2. In various examples, the device receiver 108 is configured to maintain the receiver volume shape of the receiver volume 112 when the malleable body 134 transitions from the first configuration to the second configuration. For example, the device receiver 108 may be configured to substantially maintain the cross-sectional area of ​​the device receiver perpendicular to the longitudinal axis L when the malleable body 134 transitions from the first configuration defining a first curvature C1 to the second configuration defining a curvature C2.

[0085] The delivery system body 122 may extend through the delivery lumen 118 of the delivery tool 106. In various examples, the delivery system body 122 mechanically supports the head portion 128. The head portion 128 is configured to engage the IMD 102 within the receiver volume 112. In various examples, the head portion 128 is configured to engage the retrieval structure 168 of the proximal portion 172 of the IMD. The delivery system body 122 and / or the head portion 128 are configured to translate relative to the delivery tool 106 and the device receiver 108 in the distal direction D and / or the proximal direction P within the delivery lumen 118. In various examples, the delivery system body 122 and / or head portion 128 are configured such that when the delivery system 120 (e.g., head portion 128) engages the proximal portion 172 of the IMD and the delivery system body 122 and / or head portion 128 translates relative to the delivery tool 106 and the device receiver 108 in the proximal direction P and / or distal direction D, the IMD 102 translates relative to the device receiver 108 in the proximal direction P and / or distal direction D. The delivery system 120 may be configured such that when the delivery system 120 (e.g., head portion 128) engages the IMD 102, forces applied to the delivery system body 122 (e.g., in the proximal direction P and / or distal direction D) by a clinician cause the head portion 128 to transfer forces to the IMD 102.

[0086] The delivery system body 122 and head portion 128 may be configured to rotate about a longitudinal axis L (e.g., relative to the delivery tool 106 and device receiver 108) (e.g., within the delivery lumen 118). The delivery system body 122 and / or head portion 128 may be configured to cause the IMD 102 to rotate about the device axis LD relative to the device receiver 108 when the delivery system 120 (e.g., head portion 128) engages the proximal portion 172 of the IMD and the delivery system body 122 and / or head portion 128 rotates about the delivery system axis LB relative to the delivery tool 106 and device receiver 108. The delivery system 120 may be configured such that when the delivery system 120 (e.g., head portion 128) engages the IMD 102, a torque applied to the delivery system body 122 (e.g., by a clinician) causes the delivery system 120 to transfer torque to the IMD 102. In some examples, the medical device (e.g., device receiver 108) is configured to translate the IMD 102 (e.g., in the distal direction D or the proximal direction P) when the delivery system 120 applies torque to the IMD 102. For example, the device receiver 108 may define a set of threads (e.g., internal threads on the boundary of the receiver volume 112) configured to substantially mate with a portion of the IMD 102 and / or a portion of the head portion 128. This set of threads may be configured to translate the IMD 102 and / or the head portion 128 relative to the device receiver 108 (e.g., receiver wall 113) when the delivery system 120 applies torque to the IMD 102.

[0087] In various examples, the delivery tool 106 is configured such that the distal portion 124 of the delivery system body can be slidably translated through the delivery lumen opening 166 via the delivery lumen 118, such that portions of the distal portion 124 of the delivery system body can be (e.g., by a clinician) positioned within both the delivery lumen 118 and the receptacle volume 112. The delivery tool 106 and / or the device receptacle 108 can be configured such that when the distal portion 124 of the delivery system body is positioned and / or translated within the delivery lumen 118 and / or the receptacle volume 112, the head portion 128 is positioned and / or translated within the receptacle volume 112 and / or the delivery lumen 118 (e.g., in the distal direction D and / or the proximal direction P). In various examples, the delivery lumen 118 is configured to allow (e.g., by proximal retraction) removal of the delivery system 120 from the delivery tool 106 to, for example, insert another device into the delivery lumen 118.

[0088] The head portion 128 may include any suitable mating interface or abutment that is coupled to or formed on or in the delivery system 120 and / or delivery system body 122, and configured to mate with, receive, and / or abut the IMD 102 (e.g., the proximal portion 172 of the IMD). The head portion 128 may be configured to provide a releasable attachment of the IMD 102 to the delivery system 120. In some examples, the head portion 128 may be implemented via one or more releasable, removable, retractable, or cutable ropes, filaments, threads, etc., or one or more snares to provide a releasable attachment of the IMD 102 to the delivery system 120. Such ropes, filaments, threads, snares, etc., may grip, loop through, anchor within, or otherwise interact with the IMD to facilitate such releasable attachment.

[0089] In various examples, IMD 102 includes delivery circuitry 175 (“IMD processing circuitry 175”). Medical system 100 may be configured to use IMD processing circuitry 175 to sense inherent electrical signals generated by heart 101, for example, to assess electrical activity in the vicinity of IMD 102 (e.g., in the vicinity of attachment member 132), to perform pacing mapping to determine the appropriate placement of IMD 102, to evaluate the suitability of pacing delivered by IMD 102 at a specific location, to evaluate the positioning of IMD 102 during implantation, to evaluate the placement of device electrodes relative to the vessel wall, and / or for other reasons. In various examples, IMD processing circuitry 175 is mechanically supported by a housing 170 of IMD 102 (“IMD housing 170”). IMD housing 170 may encapsulate processing circuitry 175 and / or other circuitry of IMD 102. IMD housing 170 may be configured to isolate processing circuitry 175 and / or other circuitry from environmental fluids in contact with the external surface of IMD housing 170. In various examples, the IMD housing 170 is configured to hermetically seal the package defined by the IMD 102 and holding the processing circuitry 175 and / or other circuitry. The IMD housing 170 may be configured to define a shape that is easily accepted by the patient's body while minimizing patient discomfort. For example, the IMD housing 170 may define a substantially cylindrical shape with cylindrical sidewalls. In other examples, the IMD housing 170 may define a substantially rectangular or other non-cylindrical shape. The IMD housing 170 may define a shape in which the corners and edges are designed to have relatively large radii to present a housing with an external surface having a smooth profile. In various examples, the attachment member 14 is attached to the IMD housing 170.

[0090] In some examples, the IMD 102 may mechanically support one or more device electrodes 176, such as, but not limited to, IMD electrodes 180 (e.g., supported by the distal portion 174 of the IMD), IMD return electrodes 182 supported by the IMD housing 170, and / or other electrodes supported by the 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 modulate signals sensed by device electrodes 176 and / or other electrodes within the medical system 100. The IMD 102 may include a pacemaker, such as a leadless and / or fully intracardiac pacemaker. One or more device electrodes of the device electrodes 176 may be electrically connected to processing circuitry 175. Processing circuitry 175 may be operatively connected to operating circuitry configured to use device electrodes 176 to deliver therapy to a patient and / or sense physiological signals of the patient.

[0091] Processing circuitry 175 may include fixed-function circuitry and / or programmable operating circuitry. In various examples, processing circuitry 175 includes 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 circuitry. Processing circuitry 175 described herein, along with other processors, processing circuitry, controllers, and control circuitry, may include any combination of integrated circuits, discrete logic circuitry, 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 one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, and any combination of other discrete or integrated logic circuitry and / or analog circuitry.

[0092] The functions attributable to processing circuitry 175 may be embodied in software, firmware, hardware, or any combination thereof. Processing circuitry 175 may include, for example, various electrical reservoirs, transformers, and switches configured to perform the functions of processing circuitry 175. In various 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 other device. Processing circuitry 175 may include any suitable hardware, firmware, software, or any combination thereof for communicating with another device. Furthermore, processing circuitry 175 may communicate with networked computing devices and / or computer networks. In various examples, processing circuitry 175 and / or other circuitry of medical system 100 are configured to deliver stimulation signals to and / or receive sensing signals from device electrodes 176 and / or other electrodes and / or sensors within or outside 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. The processing circuit 175 may be configured to receive electrical signals (e.g., sensed cardiac electrical signals) from the device electrode 176 and / or other electrodes within the medical system 100.

[0093] The medical system 100 (e.g., processing circuitry 175) may also include memory configured to store program instructions, such as software, which may include one or more program modules executable by the processing circuitry 175. The program instructions may be embodied in software and / or firmware. The memory may include any volatile, non-volatile, magnetic, optical, or electrical medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), ferroelectric RAM (FRAM), flash memory, or any other digital medium. In some examples, the memory includes computer-readable instructions that, when executed by the processing circuitry 175, cause the processing circuitry 175 to perform the various functions described herein and / or other functions of the processing circuitry 175.

[0094] As used herein, when a first part of a system (e.g., medical system 100) supports a second part of the system, this means that when the second part causes a first force to be applied to the first part, the first part responds to the first force by causing a second force to be applied to the second part. The first and / or second forces can be contact forces and / or long-range forces. For example, the first and / or second forces can be mechanical forces, magnetic forces, gravity, or some other type of force. The first part of the system can be a portion of the system or a component of the system. The second part of the system can be another part of the system or another part of the same or different components. In some examples, when the first part of the system supports the second part of the system, this can mean that the second part is mechanically supported and / or mechanically connected to the first part.

[0095] Figure 11 The technology used for supporting device housings is illustrated. Although the main reference is... Figures 1 to 10 The technology is described in medical system 100, but in other examples, the technology can be applied to other medical systems.

[0096] The technique includes using a delivery tool 106 to support a device receiver 108 (1102). The device receiver 108 may define a receiver volume 112 for holding the IMD 102. In various examples, a malleable body 134 of the delivery tool 106 supports the device receiver 108. In various examples, a malleable distal portion 144 of the malleable body 134 supports the device receiver 108, and a malleable proximal portion 146 of the malleable body 134 supports the malleable distal portion 144. In various examples, a delivery system 120 extends through a delivery lumen 118 of the delivery tool 106 and engages the IMD 102 (e.g., an IMD retrieval structure 168). The device receiver 108 and the malleable body 134 are configured to be inserted into one or more anatomical volumes of a patient.

[0097] The technique includes using bending forces F1 and F2 to transform the malleable body 134 from a first configuration defining a first curvature C1 to a second configuration defining a second curvature C2 different from the first curvature C1 (1104). In various examples, the technique includes using bending force F1 to transform the malleable distal portion 144 from the first configuration to the second configuration. The technique may include using bending force F2 to transform the malleable proximal portion 146 from a third configuration defining a third curvature C3 to a fourth configuration defining a fourth curvature C4 different from the third curvature C3. In various examples, transforming the malleable distal portion 144 includes defining the second curvature C2 in a first curvature plane. Transforming the malleable proximal portion 146 may include defining the fourth curvature C4 in a second curvature plane different from the first curvature plane. In various examples, when the malleable body 134 transforms from the first configuration to the second configuration, the device receiver 108 substantially maintains the shape of the receiver volume 112.

[0098] The technique includes using the malleable body 134 to hold the malleable body 134 in a second configuration (1106) when the bending forces F1 and F2 cease to act on the malleable body 134. The technique may include using a delivery tool 106 to insert at least the receiver device 108 and the malleable body 134 into the patient's body when the malleable body 134 defines a second curvature C2 and / or a fourth curvature C4. In various examples, the technique includes using the delivery tool 106 to displace at least the receiver device 108 and the malleable body 134 above a path from the right atrium of the heart 101 through the tricuspid annulus of the heart 101 and into the right ventricle of the heart 101 when the malleable body 134 defines the second curvature C2 and / or the fourth curvature C4.

[0099] This technology may include using a medical labeling device 138 to label the malleable body outer surface 148 of a malleable body 134. In various examples, the medical labeling device 138 labels the malleable body outer surface 148 by dispensing biocompatible ink. In various examples, labeling the malleable body outer surface 148 includes retaining the label from the medical labeling device 138 on the malleable body outer surface 148.

[0100] In various examples, the technique includes using the outer surface 148 of the malleable body to define markers M2, M3, which define distances along the outer surface 148 from markers M2, M3 to a reference point P1 on the device receiver 108. The technique may include using the outer surface 148 to define a first region Z1 and a second region Z2, the first region exhibiting a first visual aspect and the second region exhibiting a second visual aspect different from the first visual aspect. In various examples, the first region Z1 extends distally to markers M2, M3, and the second region Z2 extends proximally to markers M2, M3. In various examples, the technique includes using markers M2, M3, or markers from a medical marking device 138, to represent distances defined between a first anatomical structure and a second anatomical structure of the patient. The technique may include using markers M2, M3 to assess displacement (e.g., displacement within the patient) of the device receiver 108 and / or the malleable body 134 based on the displacement of markers M2, M3 relative to the patient.

[0101] The technique may include using the outer surface 148 of the malleable body to define a mark M1 indicating the positioning of a portion of the IMD 102 when it is positioned within the receptacle volume 112. The technique may include using the outer surface 148 of the malleable body to define a mark M4 indicating the rotational orientation of the delivery tool 106. The technique may include using the mark M4 to assess the rotational displacement (e.g., rotational displacement within the patient) of the device receptacle 108 and / or the malleable body 134 based on the rotational displacement of the mark M4 relative to the patient.

[0102] Various embodiments of this disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other embodiments are within the scope of the appended claims.

[0103] Example 1. A medical system comprising: a device receiver defining a receiver volume configured to receive at least a portion of an implantable medical device; and a delivery tool supporting the device receiver, wherein the delivery tool includes a malleable body configured to change 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 is applied to the malleable body, wherein the malleable body is configured to maintain the second configuration when the first bending force ceases to act on the malleable body, wherein the delivery tool defines a delivery lumen extending through the malleable body and a delivery lumen opening into the receiver volume, and wherein the device receiver and the malleable body are configured to be inserted into one or more anatomical volumes of a patient.

[0104] Example 2. The medical system according to Example 1, wherein the delivery lumen extends from a malleable proximal portion of the malleable body to a malleable distal portion of the malleable portion, wherein the malleable distal portion is distal to the malleable proximal portion.

[0105] Example 3. The medical system according to Example 2, wherein the malleable distal portion supports the device receiver.

[0106] Example 4. A medical system according to Example 2 or Example 3, wherein the malleable distal portion is configured to define a first configuration and a second configuration, wherein the malleable proximal portion is configured to change from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature when the malleable distal portion defines one of the first configuration or the second configuration and a second bending force is applied to the malleable proximal portion, and wherein the malleable body is configured to maintain the fourth configuration when the second bending force stops acting on the malleable body.

[0107] Example 5. The medical system according to Example 4, wherein the malleable distal portion is configured to define the second curvature in a first curvature plane, and wherein the malleable proximal portion is configured to define the fourth curvature in a second curvature plane different from the first curvature plane.

[0108] Example 6. A medical system according to any one of Examples 1 to 5, wherein the device receiver defines a receiver opening that opens into the receiver volume, and wherein the receiver opening is configured to allow the implantable medical device to pass through the receiver opening.

[0109] Example 7. A medical system according to any one of Examples 1 to 6, wherein the malleable body is configured to change from the first configuration to the second configuration when the bending force is less than 10 pounds.

[0110] Example 8. A medical system according to any one of Examples 1 to 7, wherein the device receiver defines a receiver volume shape of a receiver boundary, the receiver boundary defining the receiver volume, and wherein the device receiver is a substantially rigid device configured to maintain the receiver volume shape when the malleable body changes from the first configuration to the second configuration.

[0111] Example 9. A medical system according to any one of Examples 1 to 8, wherein the first curvature is defined as a curvature angle greater than about 170 degrees, and the second curvature is defined as a curvature angle less than about 120 degrees.

[0112] Example 10. A medical system according to any one of Examples 1 to 9, wherein the malleable 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.

[0113] Example 11. A medical system according to any one of Examples 1 to 10, wherein the malleable body defines an outer surface surrounding and opposite to the delivery lumen, wherein the malleable body includes one or more markings on the outer surface, and wherein each marking defines a distance along the outer surface from each marking to a reference point on the device receptacle.

[0114] Example 12. The medical system according to Example 11, wherein the outer surface includes a first region and a second region, the first region exhibiting a first visual aspect, the second region exhibiting a second visual aspect different from the first visual aspect, wherein the first region extends distally to the marks in one or more marks, and wherein the second region extends proximally to the marks in one or more marks.

[0115] Example 13. The medical system according to 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. A medical system according to any one of Examples 11 to 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. A medical system according to any one of Examples 1 to 14, wherein the malleable body is configured to displace the device receiver above a path from the right atrium of a representative heart through the tricuspid annulus of the representative heart and into the right ventricle of the representative heart.

[0118] Example 16. A medical system according to any one of Examples 1 to 15, the medical system further comprising a delivery system configured to engage the implantable medical device, wherein the delivery system is configured to perform at least one of translation or rotation relative to the delivery tool as the delivery system extends through the delivery lumen and into the receptacle volume.

[0119] Example 17. A medical system according to any one of Examples 1 to 16, wherein the delivery tool is configured to displace the device receiver above a path from the right atrium of the patient's heart through the tricuspid valve annulus of the heart and into the right ventricle of the heart.

[0120] Example 18. A medical system according to any one of Examples 1 to 17, wherein the implantable medical device includes a leadless pacemaker.

[0121] Example 19. A medical system comprising: a device receiver defining a receiver volume, a receiver opening, and a receiver axis, the receiver volume being configured to receive at least a portion of an implantable medical device, the receiver opening opening opening into the receiver volume, and the receiver axis extending from a delivery lumen opening into the receiver opening; and a delivery tool supporting the device receiver, wherein the delivery tool defines a delivery lumen and a delivery lumen opening opening into the receiver volume, wherein the delivery tool includes a malleable body including a malleable proximal portion and a malleable distal portion, the delivery lumen extending from the malleable proximal portion to the malleable distal portion, and the malleable distal portion supporting the device receiver. The device is configured to be inserted into one or more anatomical volumes of a patient's heart, wherein the malleable body is configured to change 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 is applied to the malleable body, wherein the malleable body is configured to maintain the second configuration when the first bending force ceases to act on the malleable body, wherein the device is configured to define a container volume shape of a container boundary, the container boundary defining the container volume, and wherein the device is a substantially rigid device, the substantially rigid device being configured to maintain the container volume shape when the malleable body changes from the first configuration to the second configuration.

[0122] Example 20. The medical system according to Example 19, wherein the malleable distal portion is configured to define a first configuration and a second configuration, wherein the malleable proximal portion is configured to change from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature when the malleable distal portion defines one of the first configuration or the second configuration and a second bending force acts on the malleable body, and wherein the malleable body is configured to maintain the fourth configuration when the second bending force stops acting on the malleable body.

[0123] Example 21. The medical system according to Example 20, wherein the malleable distal portion is configured to define the first curvature in a first curvature plane, and wherein the malleable proximal portion is configured to define the fourth curvature in a second curvature plane different from the first curvature plane.

[0124] Example 22. A medical system according to any one of Examples 19 to 21, wherein the malleable body defines an outer surface surrounding and opposite to the delivery lumen, and wherein the outer surface includes one or more markings on the outer surface, and wherein each of the one or more markings defines a distance along the outer surface from each marking to a reference point on the device receptacle.

[0125] Example 23. A medical system according to any one of Examples 19 to 22, wherein the malleable body includes a surface surrounding and facing away from the delivery lumen, wherein the outer surface is configured to retain a mark from a biocompatible ink of a medical marker.

[0126] Example 24. A medical system according to any one of Examples 19 to 23, wherein the delivery tool is configured to displace the device receiver above a path from the right atrium of the heart through the tricuspid valve annulus of the heart and into the right ventricle of the heart.

[0127] Example 25. A medical system according to any one of Examples 19 to 24, wherein the implantable medical device includes a leadless pacemaker.

[0128] Example 26. A method comprising: using a delivery tool to support a device receiver defining a receiver volume configured to receive at least a portion of an implantable medical device, wherein the delivery tool defines a delivery lumen and an opening into the delivery lumen in the receiver volume; using a bending force acting on a malleable body of the delivery tool to transform the malleable 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 receiver and the malleable body are configured to be inserted into one or more anatomical volumes of a patient; and using the malleable body to hold the malleable body in the second configuration when the bending force ceases to act on the malleable body.

[0129] Example 27. The method according to Example 26, the method further comprising: using the malleable distal portion of the malleable body to support the device receiver; and using the malleable proximal portion of the malleable body to support the malleable distal portion.

[0130] Example 28. The method of claim 27, wherein transforming the malleable portion from the first configuration to the second configuration comprises: using the bending force to transform a first portion of the malleable body from the first configuration to the second configuration, wherein the first portion of the malleable body is one of the malleable distal portion or the malleable proximal portion, and the method further comprises: using a second bending force to transform a second portion of the malleable 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 malleable body is the other of the malleable distal portion or the malleable proximal portion.

[0131] Example 29. The method according to Example 28, the method further comprising: using the malleable distal portion to define the second curvature in a first curvature plane; and using the malleable proximal portion to define the fourth curvature in a second curvature plane different from the first curvature plane.

[0132] Example 30. The method according to any one of Examples 26 to 29, the method further comprising: using the device container to define a container volume shape of a container boundary, the container boundary defining the container volume; and using the device container to maintain the container volume shape when the malleable body changes from the first configuration to the second configuration.

[0133] Example 31. The method according to any one of Examples 26 to 30, the method further comprising: using the surface of the malleable body surrounding and facing away from the delivery lumen to retain the biocompatible ink from the medical marking device.

[0134] Example 32. The method according to any one of Examples 26 to 31, the method further comprising: defining one or more marks on the outer surface of the malleable body surrounding and opposite to the delivery lumen, wherein each mark defines a distance along the outer surface from each mark to a reference point on the device receiver.

[0135] Example 33. The method according to Example 32, the method further comprising: using the outer surface to define a first region and a second region, the first region exhibiting a first visual aspect, the second region exhibiting a second visual aspect different from the first visual aspect, wherein the first region extends distally to the markers in the one or more markers, and wherein the second region extends proximally to the markers in the one or more markers.

[0136] Example 34. The method according to any one of Examples 31 to 33, the method further comprising: using the marker of biocompatible ink or at least one of the one or more markers to represent the distance defined between the patient's first anatomical structure and the patient's second anatomical structure.

[0137] Example 35. The method according to any one of Examples 26 to 34, the method further comprising: using the malleable body to displace the device receiver above a path from the right atrium of the heart through the tricuspid valve annulus of the heart and into the right ventricle of the heart.

[0138] Example 36. The method according to any one of Examples 26 to 35, the method further comprising: using the delivery tool to deliver the implantable medical device to at least one of the right ventricle of the patient's heart, the right atrium of the patient's heart, the left ventricle of the patient's heart, the left atrium of the patient's heart, another anatomical volume of the patient's heart, or another anatomical volume of the patient.

[0139] Example 37. The method according to any one of Examples 26 to 36, wherein the implantable medical device includes a leadless pacemaker.

Claims

1. A medical system, the medical system comprising: A device receiver defining a receiver volume configured to receive at least a portion of an implantable medical device; and Delivery tool, the delivery tool supporting the device receiver, The delivery tool includes a malleable body configured to change 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 is applied to the malleable body. The malleable body is configured to maintain the second configuration when the first bending force ceases to act on the malleable body. The delivery tool defines a delivery lumen extending through the malleable body and a delivery lumen opening into the container volume, and The device receiver and the malleable body are configured to be inserted into one or more anatomical volumes of the patient.

2. The medical system of claim 1, wherein the delivery lumen extends from a malleable proximal portion of the malleable body to a malleable distal portion of the malleable portion, wherein the malleable distal portion is distal to the malleable proximal portion.

3. The medical system of claim 2, wherein the malleable distal portion supports the device receiver.

4. The medical system according to claim 2 or claim 3, The malleable distal portion is configured to define both the first and second configurations. The malleable proximal portion is configured to change from a third configuration defining a third curvature to a fourth configuration defining a fourth curvature different from the third curvature when the malleable distal portion defines one of the first or second configurations and a second bending force acts on the malleable proximal portion. The malleable body is configured to maintain the fourth configuration when the second bending force ceases to act on the malleable body.

5. The medical system according to any one of claims 1 to 4, wherein the device receiver defines a receiver opening that opens into the receiver volume, and wherein the receiver opening is configured to allow the implantable medical device to pass through the receiver opening.

6. The medical system according to any one of claims 1 to 5, The device container defines the container volume shape of the container boundary, and the container boundary defines the container volume. The device housing is a substantially rigid device configured to maintain the volumetric shape of the housing as the malleable body transitions from the first configuration to the second configuration.

7. The medical system according to any one of claims 1 to 6, wherein the first curvature defines a curvature angle greater than about 170 degrees, and the second curvature defines a curvature angle less than about 120 degrees.

8. The medical system according to any one of claims 1 to 7, wherein the malleable 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.

9. The medical system according to any one of claims 1 to 8, wherein the malleable body defines an outer surface surrounding and opposite to the delivery lumen, wherein the malleable body includes one or more markings on the outer surface, and wherein each marking defines a distance along the outer surface from each marking to a reference point on the device receptacle.

10. The medical system of claim 9, wherein the outer surface includes a first region and a second region, the first region exhibiting a first visual aspect, the second region exhibiting a second visual aspect different from the first visual aspect, wherein the first region extends distally to the markers in the one or more markers, and wherein the second region extends proximally to the markers in the one or more markers.

11. The medical system of claim 9 or claim 10, 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.

12. The medical system according to any one of claims 1 to 11, wherein the malleable body is configured to displace the device receiver over a path from the right atrium of the representative heart through the tricuspid annulus of the representative heart and into the right ventricle of the representative heart.

13. The medical system according to any one of claims 1 to 12, further comprising a delivery system configured to engage the implantable medical device, wherein the delivery system is configured to perform at least one of translation or rotation relative to the delivery tool as the delivery system extends through the delivery lumen and into the receptacle volume.

14. The medical system according to any one of claims 1 to 13, wherein the delivery tool is configured to displace the device receiver above a path from the right atrium of the patient's heart through the tricuspid valve annulus of the heart and into the right ventricle of the heart.

15. The medical system according to any one of claims 1 to 14, wherein the implantable medical device includes a leadless pacemaker.

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