WO2025038317A1

WO2025038317A1 - Biostimulator transport system having grip mechanism

Info

Publication number: WO2025038317A1
Application number: PCT/US2024/040961
Authority: WO
Inventors: Jeremiah Blue; Bernhard Arnar; Aaron Jackson
Original assignee: Pacesetter Inc
Current assignee: Pacesetter Inc
Priority date: 2023-08-16
Filing date: 2024-08-05
Publication date: 2025-02-20
Anticipated expiration: 2026-02-16

Abstract

A biostimulator transport system includes a gripper pivotably coupled to an elongated catheter body. A wedge or a pin is movable relative to the elongated catheter body. Distal movement of the wedge causes the gripper to pivot outward from a grip state to a release state. Retraction of the pin causes the gripper to pivot outward from the grip state to the release state. A biostimulator transport system includes a capsule mounted on an elongated catheter body. The capsule includes a port extending in a distal direction through a distal capsule face from a cavity to a surrounding environment. A shuttle is slidable within the cavity, and the shuttle includes a pair of prongs longitudinally aligned with the port. Other embodiments are also described and claimed.

Description

BIOSTIMULATOR TRANSPORT SYSTEM HAVING GRIP MECHANISM

[0001] This application claims the benefit of priority from U.S. Provisional Application No. 63/532,985, titled “BIO STIMULATOR TRANSPORT SYSTEM HAVING GRIP MECHANISM” and filed August 16, 2023, which is incorporated herein by reference in its entirety.

BACKGROUND

FIELD

[0002] The present disclosure relates to biostimulators and related biostimulator transport systems. More specifically, the present disclosure relates to leadless biostimulators and related biostimulator transport systems useful for pacing cardiac tissue.

BACKGROUND INFORMATION

[0003] Cardiac pacing by an artificial pacemaker provides an electrical stimulation of the heart when its own natural pacemaker and/or conduction system fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient for a patient's health. Such antibrady cardial pacing provides relief from symptoms and even life support for hundreds of thousands of patients. Cardiac pacing may also provide electrical overdrive stimulation to suppress or convert tachyarrhythmias, again supplying relief from symptoms and preventing or terminating arrhythmias that could lead to sudden cardiac death.

[0004] Leadless cardiac pacemakers incorporate electronic circuitry at the pacing site and eliminate leads, thereby avoiding shortcomings associated with conventional cardiac pacing systems. Leadless cardiac pacemakers can be anchored at the pacing site, e.g., in a right ventricle and, for dual-chamber pacing, in a right atrium, by an anchor. A delivery system can be used to deliver the leadless cardiac pacemakers to the target anatomy.

[0005] Cardiac pacing of the His-bundle is clinically effective and advantageous by providing a narrow QRS affecting synchronous contraction of the ventricles. Deep septal pacing is an alternative to His-bundle pacing. Deep septal pacing involves pacing past the His-bundle toward the right ventricle apex. More particularly, deep septal pacing targets the left bundle branch below the His site. In any case, a leadless cardiac pacemaker can be delivered to the target tissue, e.g., in an atrium or a ventricle, by a delivery system. The delivery system can transport and affix the leadless cardiac pacemaker to the target tissue.

SUMMARY

[0006] Existing delivery systems connect to a leadless cardiac pacemaker using a set of tethers. The tethers can include features that engage the attachment feature internally. More particularly, the tethers can include protuberances that can insert sequentially, when in a misaligned state, through a hole in the attachment feature. The protuberances can be transitioned to an aligned state in which the tethers become locked within the attachment feature. The protuberances may be formed by grinding a nitinol wire to a smaller dimension proximal to the protuberances, and the smaller dimension may cause the tethers to become weakened. When subjected to repetitive flexure, e.g., within a beating heart, the weakened wires may experience mechanical fatigue, which can increase a likelihood of failure of the tethers. Accordingly, there is a need for delivery systems having engagement features that can secure the attachment feature of a leadless cardiac pacemaker with a reduced likelihood of mechanical failure.

[0007] A biostimulator transport system is described. In an embodiment, the biostimulator transport system includes an elongated catheter body, a gripper, and a wedge. The gripper is pivotably coupled to the elongated catheter body. The wedge is movable relative to the elongated catheter body. The wedge causes the gripper to pivot outward from a grip state, in which the biostimulator transport system can grip an exterior of the biostimulator, to a release state, in which the biostimulator transport system can release the exterior of the biostimulator.

[0008] A biostimulator transport system is described. In an embodiment, the biostimulator transport system include an elongated catheter body, a gripper, and a pin. The gripper is pivotably coupled to the elongated catheter body. The gripper includes a slot extending in a longitudinal direction. The pin is movable within the slot. Retraction of the pin from the slot causes the gripper to pivot outward from a grip state to a release state.

[0009] A biostimulator transport system is described. In an embodiment, the biostimulator transport system includes an elongated catheter body, a capsule, and a shuttle. The capsule is mounted on the elongated catheter body. The capsule includes a port extending in a distal direction through a distal capsule face from a cavity to a surrounding environment. The shuttle is slidable within the cavity. The shuttle includes a pair of prongs longitudinally aligned with the port. The shuttle can slide to transition the biostimulator transport system between a grip state and a release state.

[0010] The above summary does not include an exhaustive list of all aspects of the present invention. It is contemplated that the invention includes all systems and methods that can be practiced from all suitable combinations of the various aspects summarized above, as well as those disclosed in the Detailed Description below and particularly pointed out in the claims filed with the application. Such combinations have particular advantages not specifically recited in the above summary. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0012] FIG. l is a diagrammatic cross section of a patient heart illustrating an example implantation of a biostimulator in a target anatomy, in accordance with an embodiment.

[0013] FIG. 2 is a perspective view of a biostimulator system, in accordance with an embodiment.

[0014] FIG. 3 is a side view of a biostimulator, in accordance with an embodiment.

[0015] FIG. 4 is a perspective exploded view of a distal portion of a biostimulator transport system, in accordance with an embodiment.

[0016] FIG. 5 is a cross-sectional view of a distal portion of a biostimulator transport system in a grip state, in accordance with an embodiment.

[0017] FIG. 6 is a cross-sectional view of a distal portion of a biostimulator transport system in a release state, in accordance with an embodiment.

[0018] FIG. 7 is a perspective exploded view of a distal portion of a biostimulator transport system, in accordance with an embodiment.

[0019] FIG. 8 is a cross-sectional view of a distal portion of a biostimulator transport system in a grip state, in accordance with an embodiment.

[0020] FIG. 9 is a cross-sectional view of a distal portion of a biostimulator transport system in a release state, in accordance with an embodiment.

[0021] FIG. 10 is a perspective exploded view of a distal portion of a biostimulator transport system, in accordance with an embodiment. [0022] FIG. 11 is a side view of a distal portion of a biostimulator system, in accordance with an embodiment.

[0023] FIG. 12 is a cross-sectional end view of an attachment feature aligned with a port of a capsule, in accordance with an embodiment.

[0024] FIG. 13 is a cross-sectional end view of an attachment feature misaligned with a port of a capsule, in accordance with an embodiment.

[0025] FIG. 14 is a cross-sectional view of a shuttle of a biostimulator transport system in a grip state, in accordance with an embodiment.

[0026] FIG. 15 is a cross-sectional view of a shuttle of a biostimulator transport system in a release state, in accordance with an embodiment.

DETAILED DESCRIPTION

[0027] Embodiments describe a biostimulator transport system, such as a delivery system or a retrieval system, to transport a biostimulator. As described below, the biostimulator can be a leadless pacemaker used to perform pacing of a heart. The biostimulator may, however, be used in other applications, such as deep brain stimulation. Thus, reference to the biostimulator transport system as being used for cardiac pacing is not limiting.

[0028] In various embodiments, description is made with reference to the figures.

However, certain embodiments may be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the following description, numerous specific details are set forth, such as specific configurations, dimensions, and processes, in order to provide a thorough understanding of the embodiments. In other instances, well-known processes and manufacturing techniques have not been described in particular detail in order to not unnecessarily obscure the description. Reference throughout this specification to “one embodiment,” “an embodiment,” or the like, means that a particular feature, structure, configuration, or characteristic described is included in at least one embodiment. Thus, the appearance of the phrase “one embodiment,” “an embodiment,” or the like, in various places throughout this specification are not necessarily referring to the same embodiment. Furthermore, the particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0029] The use of relative terms throughout the description may denote a relative position or direction. For example, “distal” may indicate a first direction along a longitudinal axis of a biostimulator transport system. Similarly, “proximal” may indicate a second direction opposite to the first direction. Such terms are provided to establish relative frames of reference, however, and are not intended to limit the use or orientation of a biostimulator transport system to a specific configuration described in the various embodiments below. [0030] In an aspect, a biostimulator transport system includes a grip mechanism capable of securing a biostimulator without tethers. The grip mechanism can reduce mechanical stress on the biostimulator transport system and, thus, reduce a likelihood of mechanical failure. Mechanical stress can be reduced in several ways. First, the grip mechanism may not rely on tension to secure an attachment feature of the biostimulator and, thus, tensile stress on the transport system components can be reduced. Second, the grip mechanism can encapsulate a portion of the biostimulator such that axial alignment between the biostimulator and the transport system is improved. Enhanced axial alignment can reduce stress caused by side loads on the biostimulator. Third, the grip mechanism can connect a catheter to the biostimulator via engagement of the biostimulator externally. Securing the biostimulator transport system to an exterior of the biostimulator, rather than relying on internal engagement, can allow for a more robust gripping mechanism compared to delicate tethers. Accordingly, the biostimulator transport systems described below can reduce a likelihood of mechanical failure during use. [0031] Referring to FIG. 1, a diagrammatic cross section of a patient heart illustrating an example implantation of a biostimulator in a target anatomy is shown in accordance with an embodiment. A leadless biostimulator system, e.g., a cardiac pacing system, includes one or more biostimulators 100. The biostimulator 100 can be implanted in a patient heart 102, and can be leadless (and thus, may be a leadless cardiac pacemaker). Each biostimulator 100 can be placed in a cardiac chamber, such as a right atrium and/or right ventricle of the heart 102, or attached to an inside or outside of the cardiac chamber. For example, the biostimulator 100 can be attached to a septum 104 of the heart 102. More particularly, the biostimulator 100 can be delivered to the septum 104, and one or more elements, such as a fixation element 106 and/or a pacing element 108 can pierce a septal wall 110 of the septum 104 to engage and anchor the biostimulator 100 to the target anatomy, e.g., a bundle branch 112 in the septal wall 110. In a particular embodiment, the biostimulator 100 can use two or more electrodes located on or within a housing of the biostimulator 100 for pacing the cardiac chamber upon receiving a triggering signal from at least one other device within the body. In an embodiment, one or more of the fixation element 106 or the pacing element 108 is an active electrode.

[0032] When the biostimulator 100 is delivered to and screwed into the target tissue, e.g., an atrial or ventricular wall, or a septum 104 of the heart 102, the pacing element 108 and/or the fixation element 106 may be positioned for pacing. For example, in the case of deep septal pacing at respective bundle branches 112 in the septum 104, an active electrode of the pacing element 108 can be positioned at a first target anatomy in the septal wall 110, e.g., a left bundle branch 114. Similarly, the fixation element 106 can be positioned at a second target anatomy in the septal wall, e.g., a right bundle branch 116. Optionally, one of the elements may be at a bundle branch and the other element may not be at a bundle branch. [0033] Referring to FIG. 2, a perspective view of a biostimulator system is shown in accordance with an embodiment. A biostimulator system 200 can include the biostimulator 100, e.g., a leadless pacemaker or other leadless biostimulator. The biostimulator system 200 can include delivery or retrieval systems, which may be catheter-based systems used to carry the biostimulator 100 intravenously to or from a patient anatomy. For example, a biostimulator transport system 202 can be used to deliver the biostimulator 100 to, or retrieve the biostimulator from, a patient. The biostimulator 100 can be attached, connected to, or otherwise mounted on the biostimulator transport system 202. The biostimulator 100 can be mounted on a distal end of a catheter of the biostimulator transport system 202. The biostimulator 100 is thereby advanced intravenously into or out of the heart 102.

[0034] The biostimulator transport system 202 can include a handle 204 to control movement and operations of the transport system from outside of a patient anatomy. One or more elongated members extend distally from the handle 204. For example, an elongated catheter body 206 can extend distally from the handle 204. The elongated catheter body 206 can extend to a distal end of the biostimulator transport system 202. In an embodiment, the biostimulator 100 is mounted on a distal end of the elongated catheter body 206.

[0035] The biostimulator transport system 202 can include a protective sleeve 208 to cover the biostimulator 100 during delivery and implantation. The protective sleeve 208 can extend over, and be longitudinally movable relative to, the elongated catheter body 206. The biostimulator transport system 202 may also include an introducer sheath 210 that can extend over, and be longitudinally movable relative to, the protective sleeve 208. The introducer sheath 210 can cover a distal end of the protective sleeve 208, the elongated catheter body 206, and the biostimulator 100 as those components are passed through an access device into the patient anatomy. [0036] Several components of the biostimulator transport system 202 are described above by way of example. It will be appreciated, however, that the biostimulator transport system 202 may be configured to include additional or alternate components. More particularly, the biostimulator transport system 202 may be configured to deliver and/or retrieve the biostimulator 100 to or from the target anatomy. Delivery and/or retrieval of the biostimulator 100 can include retaining the biostimulator 100 during transport to the target anatomy and rotation of the biostimulator 100 during implantation of the biostimulator at the target anatomy. Accordingly, the biostimulator transport system 202 can incorporate features to retain and rotate the biostimulator 100.

[0037] Referring to FIG. 3, a side view of a biostimulator having a movable pacing element is shown in accordance with an embodiment. The biostimulator 100 can be a leadless cardiac pacemaker that can perform cardiac pacing and that has many of the advantages of conventional cardiac pacemakers while extending performance, functionality, and operating characteristics. The biostimulator 100 can have two or more electrodes, e.g., a portion of the pacing element 108 that acts as an active electrode and/or a portion of the fixation element 106 that acts as an active electrode. The electrodes can deliver pacing pulses to target tissue, and optionally, can sense electrical activity from the tissue. The electrodes may also communicate bidirectionally with at least one other device within or outside the body.

[0038] In an embodiment, the biostimulator 100 includes a housing 302 having a longitudinal axis 304. The housing 302 can contain a primary battery to provide power for pacing, sensing, and communication, which may include, for example, bidirectional communication. The housing 302 can optionally contain an electronics compartment 306 (shown by hidden lines) to hold pacing circuitry adapted for different functionality. For example, pacing circuitry in the electronics compartment 306 can include circuits for sensing cardiac activity from the electrodes, circuits for receiving information from at least one other device via the electrodes, circuits for generating pacing pulses for delivery to tissue via the electrodes, or other circuitry. The electronics compartment 306 may contain circuits for transmitting information to at least one other device via the electrodes and can optionally contain circuits for monitoring device health. The circuit of the biostimulator 100 can control these operations in a predetermined manner. In some implementations of a cardiac pacing system, cardiac pacing is provided without a pulse generator located in the pectoral region or abdomen, without an electrode-lead separate from the pulse generator, without a communication coil or antenna, and without an additional requirement of battery power for transmitted communication.

[0039] Leadless pacemakers or other leadless biostimulators 100 can be fixed to an intracardial implant site, e.g., at the septal wall 110, by one or more actively engaging mechanisms or fixation mechanisms. The fixation element 106 can include a structure to engage and affix to tissue. For example, the fixation element 106 may include a helical or non-helical fixation mechanism. Helical fixation mechanisms are shown in the figures and may include a spiral-wound wire to thread into tissue. Non-helical fixation mechanisms may, for example, include one or more tines to extend longitudinally into and laterally outward within tissue. Other fixation mechanisms include barbs, hooks, etc. In an embodiment, the biostimulator 100 includes the fixation element 106 coupled to the housing 302. More particularly, the biostimulator 100 can include a header assembly having a flange 308 coupled to a distal housing end 309 of the housing 302. The fixation element 106 can extend helically from the flange 308 about the longitudinal axis 304 to a helix tip 312. Accordingly, when the biostimulator 100 is delivered to the target tissue, the helix tip 312 can pierce the tissue and the housing 302 can be rotated to screw the fixation element 106 into the target tissue. [0040] In an embodiment, the biostimulator 100 includes an attachment feature 310. The attachment feature 310 can be mounted on a proximal housing end 313 of the housing 302. More particularly, the attachment feature 310 can be mounted on an opposite end of the housing 302 from the fixation element 106 and the pacing element 108, which can instead be coupled to the distal housing end 309 of the housing 302. The attachment feature 310 can facilitate precise delivery or retrieval of the biostimulator 100. For example, the attachment feature 310 can be formed from a rigid material to allow the biostimulator transport system 202 to engage the attachment feature 310. The biostimulator transport system 202 can therefore deliver the biostimulator to the target tissue and transmit torque to the attachment feature 310 to screw one or more of the fixation element 106 or the pacing element 108 into the target tissue.

[0041] The biostimulator 100 can be carried at a distal end of the biostimulator transport system 202. For example, the biostimulator transport system 202 can include a grip mechanism to connect to the attachment feature 310 of the biostimulator 100. The grip mechanism may, in addition to or instead of engaging the attachment feature 310 internally, engage an external surface of the attachment feature 310. For example, the grip mechanism may encapsulate at least a portion of the attachment feature 310 and/or a proximal portion of the housing 302. Several embodiments of such grip mechanism are described below.

[0042] Referring to FIG. 4, a perspective exploded view of a distal portion of a biostimulator transport system is shown in accordance with an embodiment. The biostimulator transport system 202 can include a gripper 402 pivotably coupled to the elongated catheter body 206. In an embodiment, the gripper 402 includes one or more gripper jaws. For example, the gripper 402 can include a first gripper jaw 404 coupled to the elongated catheter body 206 at a first hinge point 408, and a second gripper jaw 406 coupled to the elongated catheter body 206 at a second hinge point 410. The hinge points and/or the gripper jaws can be on opposite sides of the longitudinal axis 304. More particularly, the longitudinal axis 304 can be aligned with a central axis of the elongated catheter body 206, and the gripper jaws may be on opposite sides of the longitudinal axis 304.

[0043] The gripper jaws may be indirectly connected to the elongated catheter body 206. For example, the biostimulator transport system 202 may include a gripper housing 412 mounted on the elongated catheter body 206, and the gripper 402 may be pivotably coupled to the gripper housing 412. The first gripper jaw 404 can be pivotably coupled to the gripper housing 412 by a first hinge pin 420. Similarly, the second gripper jaw 406 can be pivotably coupled to the gripper housing 412 by a second hinge pin 422. The hinge pins allow, as shown in FIGS. 5-6, the gripper jaws to move outward relative to each other. The gripper 402 can therefore pinch or encapsulate a portion of the attachment feature 310 in a grip state (FIG. 5) and splay outward to expose or disengage the portion of the attachment feature 310 in a release state (FIG. 6).

[0044] The gripper 402, e.g., one or more of the gripper jaws, can include a recess to receive the attachment feature 310 of the biostimulator 100 when the gripper 402 is in the grip state. In an embodiment, the first gripper jaw 404 has a first recess 424. The first recess 424 can be a divot or cavity formed in a sidewall of the gripper jaw. The sidewall can face the longitudinal axis 304 in the grip state (and spread outward away from the longitudinal axis 304 in the release state). Accordingly, a portion of the attachment feature 310 can extend laterally outward from the longitudinal axis 304 into the first recess 424 to be secured and retained by the gripper 402 in the grip state.

[0045] The biostimulator transport system 202 can include a mechanism to actuate the gripper 402 between the grip state and the release state. In an embodiment, the actuation mechanism includes a wedge 430 movable relative to the elongated catheter body 206. More particularly, the wedge 430 can move distally or proximally, e.g., along the longitudinal axis 304. Distal movement of the wedge 430 can cause the gripper 402 to pivot outward from the grip state to the release state. By contrast, proximal movement of the wedge 430 can cause the gripper 402 to pivot inward from the release state to the grip state. Accordingly, the wedge 430 can be actuated to control opening and closing of the gripper 402 and, thus, to control the retention or release of the biostimulator 100.

[0046] Actuation of the wedge 430 may be controlled by a control member. The control member can be a longitudinal element extending from the wedge 430 to the handle 204. Movement of the control member can transmit a load to move the wedge 430 and, thus, transition the gripper 402 between the grip state and the release state. In an embodiment, the control member includes an inner shaft 432. The inner shaft 432 can extend through the elongated catheter body 206. The wedge 430 may be coupled to the inner shaft 432 such that longitudinal movement of the inner shaft 432 within the elongated catheter body 206 causes corresponding movement of the wedge 430. More particularly, the inner shaft 432 may be slidable within the elongated catheter body 206 to move the wedge 430 relative to the elongated catheter body 206.

[0047] Referring to FIG. 5, a cross-sectional view of a distal portion of a biostimulator transport system in a grip state is shown in accordance with an embodiment. The second gripper jaw 406 can, similar to the first gripper jaw 404, have a second recess 502. More particularly, outer surfaces of the gripper jaws can define the recesses. In an embodiment, the first recess 424 faces the second recess 502 when the gripper 402 is in the grip state. Apices of the recess cavities, e.g., the deepest locations in the cavities, can be laterally separated.

For example, the apices can be diametrically offset on opposite sides of the longitudinal axis 304.

[0048] In the grip state, the attachment feature 310 of the biostimulator 100 can fit within the recesses of the gripper 402. Each recess of the gripper 402 can be defined between longitudinally separated portions of the gripper jaws, which may be referred to as gripper teeth 504. The gripper teeth 504 can engage longitudinally facing surfaces of the attachment feature 310. Accordingly, the teeth can secure the attachment feature 310 and constrain longitudinal movement of the biostimulator 100.

[0049] The gripper jaws may be freely pivotable relative to the elongated catheter body 206 when not constrained by an external component. Accordingly, the wedge 430 can be used to engage and constrain the gripper jaws in the grip state. For example, the wedge 430 may include a wedge hook 506 to engage a corresponding gripper hook 508 of the gripper 402. The wedge hook 506 and the gripper hook 508 can be directed in opposite directions such that longitudinal movement toward each other results in the hooks engaging and locking together.

[0050] The wedge hook 506 can engage the gripper hook 508 when the gripper 402 is in the grip state. The inner shaft 432 can be pulled to place the shaft and the wedge 430 in tension. More particularly, the wedge hook 506 can be forced into compression against the gripper hook 508. The compression of the wedge hook 506 against the gripper hook 508 allows the wedge 430 to constrain the gripper 402 and prevent movement of the gripper hook 508 in a distal direction. Accordingly, tension in the inner shaft 432 can keep the gripper jaws closed, and the gripper jaws can retain the biostimulator 100.

[0051] When the wedge 430 is locked against the gripper 402, compressive forces between the wedge 430 and the gripper jaws at several locations can resist opening of the gripper 402. For example, as described above, the gripper hook 508 and wedge hook 506 can press together and the wedge 430 can prevent movement of the gripper hook 508 in the distal direction. Similarly, laterally facing surfaces of the hooks may contact along a longitudinal surface interface. The conforming hooks can therefore resist lateral movement of each other. More particularly, the laterally facing and contacting surfaces of the gripper hook 508 and the wedge hook 506 can press against each other to resist outward movement of the gripper hook 508. Accordingly, the gripper hooks 508 can be locked in place to resist outward movement of the gripper jaws about the hinge pins, and to prevent the gripper 402 from opening. Also, the inside corners and/or faces of the wedge 430 and the gripper jaws can contact each other to constrain the jaws. For example, the surfaces of the wedge 430 and the gripper 402 that are radially between the hinge pins 420 may be in contact. The inside comers, e.g., a portion of the interface proximal to the hinge pins 420 (and still radially between the hinge pins 420) can press against each other to resist inward pivoting of the inside corners of the gripper 402 about the hinge pins 420. Accordingly, the wedge 430 can resist pivoting of the gripper jaws. The gripper 402 can, by extension, securely lock onto the attachment feature 310 to resist sideloading and retain the biostimulator 100 securely during delivery to a target site.

[0052] Referring to FIG. 6, a cross-sectional view of a distal portion of a biostimulator transport system in a release state is shown in accordance with an embodiment. When the biostimulator 100 is delivered to the target site, the fixation element 106 can be driven into the target tissue. After the biostimulator 100 is affixed to the target tissue, a user can control the gripper 402 to release the biostimulator 100. Actuation of the gripper 402 can be affected via the handle 204. For example, and actuation knob or lever (not shown) can be manipulated to ease tension on or push forward the inner shaft 432. Distal movement of the inner shaft 432 may be transmitted to the wedge 430. The wedge 430 can advance forward within the space located laterally between the gripper jaws. More particularly, the wedge 430 can push forward to disengage the wedge hook 506 from the gripper hook 508.

[0053] When the apices of the hook teeth have passed longitudinally beyond each other, the wedge hook 506 and the gripper hook 508 can disengage. The apex of the wedge hook

506 teeth can be a proximalmost location on the wedge hook 506. Similarly, the apex of the gripper teeth 504 may be a distalmost location on the gripper hook 508. When the hooks are disengaged, the wedge 430 can reside within the space formed laterally between the gripper jaws and longitudinally between the gripper teeth 504 and the gripper hook 508.

[0054] In an embodiment, the wedge 430 can press forward against a sloped surface 602 of the gripper teeth 504. The slope surface can be angled or slanted such that, as the wedge 430 rides over the slope surface, the gripper jaw is forced to pivot outward about the hinge pins. The attachment feature 310 can move out of the recesses of the gripper jaws. Forward movement of the wedge 430 can therefore push the gripper 402 outward to release the biostimulator 100.

[0055] Referring to FIG. 7, a perspective exploded view of a distal portion of a biostimulator transport system is shown in accordance with an embodiment. The biostimulator transport system 202 can include alternative mechanisms to control the gripper 402. In an embodiment, biostimulator transport system 202 incorporates a pin 702 that can move longitudinally to constrain or release the gripper jaws. For example, as described below, the pin 702 may sit inside a center hole of the grippers 402 to constrain the grippers 402 in the grip state. The gripper 402 can therefore retain biostimulator 100 in the grip state. After the biostimulator 100 is affixed to the target tissue, the pin 702 may be moved proximally out of the center hole to release the gripper 402. The gripper jaws can therefore open to release the biostimulator 100 at the target site. Several components of the biostimulator transport system 202 illustrated in FIG. 7 are similar to those described above with respect to the embodiment of the biostimulator transport system 202 illustrated in FIG.

4. Thus, it will be appreciated that the description provided above may apply to components of the biostimulator transport system 202 shown in FIG. 7.

[0056] Biostimulator transport system 202 can include the gripper 402 pivotably coupled to the elongated catheter body 206. Gripper housing 412 may be mounted on the elongated catheter body 206, and the pair of gripper jaws may be pivotably coupled to the gripper housing 412. The pair of gripper jaws can be pivotably coupled to the gripper housing 412 by respective hinge pins. For example, the first gripper jaw 404 can be connected to the gripper housing 412 by the first hinge pin 422, and the second gripper jaw 406 can be connected to the gripper housing 412 by the second hinge pin 420. The gripper 402 can include the recesses in the gripper jaws to receive the attachment feature 310 of the biostimulator 100 when the gripper 402 is in the grip state.

[0057] Rather than securing the gripper 402 by the wedge 430, in an embodiment, the pin 702 can insert into one or more slots of the gripper 402. For example, the gripper 402 can include a slot 704 extending in a longitudinal direction along the longitudinal axis 304. The slot 704 can be a longitudinal channel or groove extending along an inward surface 706 of the first gripper jaw 404. The slot 704 can have a shape that conforms to the pin 702. For example, the pin 702 may have a cylindrical outer surface, and the slot 704 may have a negative space that is semi -cylindrical. The pin 702 may therefore fit within the slot 704, and appose at least a portion of the gripper jaw, e.g., jaw material above and below the slot 704, to resist movement of the gripper jaw.

[0058] The second gripper jaw 406 may, like the first gripper jaw 404, have a corresponding or respective slot. More particularly, the second gripper jaw 406 can have a second slot (hidden) formed in a second inward surface (hidden) facing the inward surface 706 of the first gripper jaw 404. The second slot may be shaped to conform to an opposite side of the pin 702 than the portion of the pin 702 that fits within the slot 704 of the first gripper jaw 404. The slot 704 and the second slot can form a longitudinal hole when the gripper 402 is in the grip state. Whereas both slots may have semi-cylindrical profiles, when the slots are aligned with each other they can form a cylindrical central hole within which the pin 702 may be inserted. More particularly, the slot 704 and the second slot can form the longitudinal hole when the gripper 402 is in the grip state. [0059] The pin 702 can be movable within the central hole, e.g., longitudinally within the slot 704 and/or the second slot. The pin 702 may be advanced distally into the slots to lock the gripper 402 in the grip state (FIG. 8). The pin 702 may, however, be retracted from the slot 704 to allow the gripper 402 to splay outward. For example, the pin 702 may be retracted from the slot 704 to allow the gripper 402 to pivot outward to the release state (FIG. 9). Accordingly, the pin 702-actuated gripper 402 can secure the biostimulator during delivery, and release the biostimulator at the target site after affixation of the biostimulator 100 to the target tissue is achieved.

[0060] Referring to FIG. 8, a cross-sectional view of a distal portion of a biostimulator transport system in a grip state is shown in accordance with an embodiment. In the grip state, the pin 702 extends longitudinally through the slot 704. The slot 704 can extend between the gripper jaws distal to the gripper housing 412. For example, the slot 704 may include a space between the first recess 424 of the first gripper jaw 404 and the second recess 502 of the second gripper jaw 406. Accordingly, the pin 702 may extend between the first recess 424 and the second recess 502, and fill the slot 704, when the gripper 402 is in the grip state. In an embodiment, the pin 702 extends into the attachment feature 310, e.g., such as through a central hole formed in a proximal end of the attachment feature 310. The pin 702 may therefore stabilize the biostimulator 100 by placing pressure on the attachment feature 310. The pressure can reduce shifting between the attachment feature 310 and the gripper 402, and can reduce a likelihood of the attachment feature 310 disengaging from the gripper 402 during delivery.

[0061] The biostimulator transport system 202 can include the inner shaft 432 connected to the pin 702. For example, the inner shaft 432 can be longitudinally slidable within the elongated catheter body 206 to advance or retract the pin 702 from the slot 704. The inner member may be a shaft, a cable, or another elongated member capable of transmitting loads from an actuation mechanism at the handle 204 to the pin 702 at the distal end of the biostimulator transport system 202.

[0062] The pin 702, when inside the center hole of the gripper 402, can retain the biostimulator 100. Unlike the wedge 430, the pin 702 may not require compression to be applied to the gripper 402 in order to keep the gripper jaws closed. Rather, the pin 702 may interfere with opposing surfaces of the gripper jaws. For example, an outer surface of the pin 702 can engage and resist transverse movement of the jaw surfaces surrounding the slot 704. Outward movement of the first gripper jaw 404 may be resisted by a first side of the pin 702, and outward movement of the second gripper 402 job may be resisted by a second side of the pin 702. Passive interference between the pin 702 and the gripper jaws can therefore lock the gripper jaws in place, as opposed to active compression of the gripper applied by the wedge 430.

[0063] Referring to FIG. 9, a cross-sectional view of a distal portion of a biostimulator transport system in a release state is shown in accordance with an embodiment. Whereas placement of the pin 702 within the center hole can prevent the gripper jaws from opening, retraction of the pin 702 from the slot 704 can allow the gripper jaws to splay outward. The inner shaft 432 may be pulled to retract the pin 702 from the slot 704 of the first gripper jaw 404 and the second slot of the second gripper jaw 406. When the pin 702 is retracted, e.g., into a central lumen of the elongated catheter body 206, the pin no longer interferes with the surfaces of the gripper jaws. The gripper jaws can therefore pivot outward about the respective hinges. The inward surfaces 706 of the gripper jaws can slide across each other, and a distance between the recesses in the gripper jaws can increase. As the distance increases, the space between the gripper jaws also widens, and the attachment feature 310 the biostimulator 100 may be released. The biostimulator transport system 202 can subsequently be retracted from the target anatomy while allowing the biostimulator 100 to remain affixed to the target tissue to achieve implantation.

[0064] Referring to FIG. 10, a perspective exploded view of a distal portion of a biostimulator is shown in accordance with an embodiment. The biostimulator transport system 202 can include a capsule 1002 to receive and support the biostimulator 100. The capsule 1002 can be mounted on the elongated catheter body 206 and may have several portions. For example, the capsule 1002 can include a distal capsule portion 1004 connected to a proximal capsule portion 1006. The capsule portions may be attached to each other, however, in the exploded view of FIG. 10, the capsule portions are separated to provide a view of the internal working components.

[0065] The capsule 1002 can include a port 1008 extending in a distal direction through a distal capsule face 1010. The distal capsule face 1010 can be a transverse wall of the capsule 1002 separating an internal working volume, e.g., a cavity 1012, from a surrounding environment. Biostimulator 100 is depicted in the surrounding environment distal to the distal capsule face 1010. More particularly, the biostimulator 100 is depicted in a released location, distal to the distal capsule portion 1004.

[0066] The internal working components of the capsule 1002 are configured to engage the attachment feature 310 of the biostimulator 100 in the grip state, and to disengage from the attachment feature 310 in the release state. The components can include a shuttle 1014 located within the cavity 1012. The shuttle 1014 may be slidable within the cavity 1012. As described below, the shuttle 1014 can include several, e.g., a pair, of prongs 1015. The prongs 1015 can align longitudinally with the port 1008. More particularly, the prongs 1015 can, in an end view, be aligned with the hole forming the port 1008 through the distal capsule face 1010. The prongs 1015 can contact a proximal end of the attachment feature 310 when the biostimulator 100 is inserted into the port 1008, and upon rotation of the biostimulator 100 by 90°, the attachment feature 310 can shift into a gap between the prongs 1015, to be cradled by the prongs 1015.

[0067] In an embodiment, the shuttle 1014 is spring-loaded. For example, the biostimulator transport system 202 can include a spring 1016 in the cavity 1012, which imparts an axial load to the shuttle 1014. More particularly, the spring 1016 can bias the shuttle 1014 in the distal direction. The spring-loaded shuttle 1014 can therefore retract within the cavity 1012 when the prongs 1015 contact the proximal end of the attachment feature 310, however, when the attachment feature 310 is cradled between the prongs 1015, the shuttle 1014 can shift forward within the cavity 1012.

[0068] Movement of the shuttle 1014 within the cavity 1012 can be actuated by external loading. For example, manual insertion of the biostimulator 100 into the port 1008 can cause the attachment feature 310 to press against the prongs 1015 and push the shuttle 1014 backward. Similarly, the biostimulator transport system 202 may include a release wire 1018 to actuate the shuttle 1014. The release wire 1018 can be coupled to and extend proximally from the shuttle 1014 through the elongated catheter body 206. More particularly, the release wire 1018 can extend through a central lumen of the elongated catheter body 206 between the shuttle 1014 and the handle 204. The release wire 1018 may be actuated by a knob or lever of the handle 204, for example, and retraction of the release wire 1018 can pull on the shuttle 1014 to displace the shuttle 1014 proximally within the cavity 1012. The spring 1016 can act against the shuttle 1014 such that removal of the proximal load by the release wire 1018 can allow the shuttle 1014 to return to the neutral, forward position.

[0069] In addition to the cavity 1012 to hold the attachment feature 310 within the capsule 1002 when the biostimulator 100 is held in the grip state, the capsule 1002 may include a receiving socket 1020 to receive a portion of the biostimulator housing 302. The receiving socket 1020 can be a space located distal to the distal capsule face 1010. More particularly, receiving socket 1020 may be a space on an opposite side of the transverse wall having the port 1008 from the cavity 1012. The receiving socket 1020 may be defined by an interior surface 1022 of the capsule 1002. The interior surface 1022 may be a cylindrical surface extending circumferentially around the longitudinal axis 304. More particularly, the interior surface 1022 can have a distal cylindrical profile. The distal cylindrical profile may conform to an outer cylindrical surface of the biostimulator 100. Accordingly, the interior surface 1022 surrounding the receiving socket 1020 can conform to and support the outer surface of the biostimulator 100 when the attachment feature 310 is received within the cavity 1012.

[0070] Referring to FIG. 11, a side view of a distal portion of a biostimulator is shown in accordance with an embodiment. The capsule portions can be connected to form a unitary capsule 1002. When the biostimulator 100 is inserted into the capsule 1002, the proximal portion, such as the attachment feature 310, can insert through the distal capsule face 1010 into the cavity 1012. A portion of the biostimulator housing 302 can reside within the receiving socket 1020. The interior surface 1022 of the capsule 1002 can surround and support the biostimulator housing 302. Such support is described further with respect to FIGS. 14-15, below. Accordingly, the capsule 1002 can securely attached to the biostimulator 100 and limit relative transverse movement between the biostimulator 100 and biostimulator transport system 202.

[0071] Referring to FIG. 12, a cross-sectional end view of an attachment feature aligned with a port of a capsule is shown in accordance with an embodiment. The port 1008 of the capsule 1002 can be keyed such that the attachment feature 310 may only be inserted into the cavity 1012 in one orientation. In an embodiment, the port 1008 has a non-circular profile. For example, the non-circular profile may be an elliptical or polygonal profile. The noncircular profile can match a shape of the attachment feature 310. Cross-sectional profiles of the attachment feature 310 and the port 1008 can conform to each other. For example, both the port 1008 and the attachment feature 310 may be elliptically shaped such that the attachment feature 310 can only insert through the port 1008 in one rotational orientation. In the aligned orientation shown in FIG. 12, the capsule 1002 is in the release state such that the attachment feature 310 can freely move through the port 1008 and slip out of the distal capsule portion 1004.

[0072] Referring to FIG. 13, a cross-sectional end view of an attachment feature misaligned with a port of a capsule is shown in accordance with an embodiment. When the attachment feature 310 is misaligned with the port 1008, the biostimulator 100 cannot slip through the distal capsule portion 1004. After inserting the attachment feature 310 through the port 1008, a user can rotate the biostimulator 100 to misalign the attachment feature 310 with the port 1008. For example, the user can rotate the biostimulator 100 by 90°, in a manner similar to twisting a key in a lock.

[0073] Whereas the attachment feature 310 can press the prongs 1015 of the shuttle 1014 backward in FIG. 12, the prongs 1015 can recover to the neutral position when the attachment feature 310 is rotated into the space between the prongs 1015. More particularly, the prongs 1015 can slide forward to cradle the attachment feature 310 and longitudinally align with the port 1008 on either side of the attachment feature 310. The transverse wall 1302 of the capsule 1002 can resist longitudinal movement of the attachment feature 310, and the prongs 1015 can maintain the attachment feature 310 in the misaligned orientation, such that the capsule 1002 locks onto and secures the biostimulator 100.

[0074] Referring to FIG. 14, a cross-sectional view of a shuttle of a biostimulator transport system in a grip state is shown in accordance with an embodiment. In the grip state, the attachment feature 310 is cradled between the prongs 1015 of the shuttle 1014. More particularly, the prongs 1015 extend forward from a shuttle 1014 body, and a lateral space between the prongs 1015 receives the attachment feature 310. The shuttle 1014 can keep the button in place. More particularly, the spring 1016 can press the shuttle 1014 forward to maintain the prongs 1015 on either side of the attachment feature 310.

[0075] The lateral support provided to the biostimulator 100 by the capsule 1002 is evident in the cross-sectional view. The receiving socket 1020 can have a distal cylindrical profile 1402 can conform to and surround the cylindrical biostimulator housing 302. In an embodiment, the receiving socket 1020 includes a taper profile 1404 between the distal cylindrical profile 1402 and the distal capsule face 1010 (FIG. 10). Taper profile 1404 can conform to and abut a proximal taper of the biostimulator housing 302. The proximal taper can extend from the outer cylindrical profile of the biostimulator 100 to a neck of the attachment feature 310. Accordingly, the interior of the capsule 1002 can surround, conform to, and support the proximal portion of the biostimulator 100 during delivery to the target site.

[0076] Referring to FIG. 15, a cross-sectional view of a shuttle of a biostimulator transport system in a release state is shown in accordance with an embodiment. The shuttle 1014 can keep the attachment feature 310 in place within the capsule 1002. When the shuttle 1014 is pulled proximally, however, the attachment feature 310 can be rotated and released from the capsule 1002. In an embodiment, when the fixation element 106 is driven into the target tissue, the release wire 1018 can be pulled to retract the shuttle 1014 within the cavity 1012. The capsule 1002 can include an interior cavity surface 1502 surrounding the cavity 1012. The interior cavity surface 1502 may have a groove 1504 extending longitudinally within the cavity 1012. For example, the groove 1504 can be a channel formed in the interior cavity surface 1502. The groove 1504 may receive a portion of the shuttle 1014. For example, the shuttle 1014 can include a protrusion 1506 seated in the groove 1504. The protrusion 1506 may therefore act like a key in the groove 1504 to constrain rotational movement of the shuttle 1014 as it slides within the cavity 1012. More particularly, the groove 1504 can guide the shuttle 1014 to maintain the shuttle 1014 in a same rotational orientation. The prongs 1015 may therefore remain longitudinally align with the port 1008.

[0077] When the shuttle 1014 is retracted within the cavity 1012, the spring 1016 can be compressed and a space can be created distal to the shuttle 1014, between the transverse wall 1302 of the capsule 1002 and the prongs 1015 of the shuttle 1014, to allow the attachment feature 310 to rotate relative to the capsule 1002. More particularly, the handle 204 may be rotated to move the capsule 1002 relative to the biostimulator 100. Rotation of the capsule 1002 can cause the shuttle 1014 to rotate relative to the attachment feature 310. The prongs 1015 of the shuttle 1014 can therefore align with the proximal end of the attachment feature 310. When the prongs 1015 are aligned with the attachment feature 310, the attachment feature 310 may also be aligned with the port 1008. The handle 204 and the elongated catheter body 206 can therefore be retracted to pull the capsule 1002 away from the biostimulator 100. Implantation of the biostimulator 100 can be achieved, and the biostimulator transport system 202 may be removed from the target anatomy.

[0078] In the foregoing specification, the invention has been described with reference to specific exemplary embodiments thereof. It will be evident that various modifications may be made thereto without departing from the broader spirit and scope of the invention as set forth in the following claims. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.

Claims

CLAIMS What is claimed is:

1. A biostimulator transport system, comprising: an elongated catheter body; a gripper pivotably coupled to the elongated catheter body; and a wedge movable relative to the elongated catheter body, wherein distal movement of the wedge causes the gripper to pivot outward from a grip state to a release state.

2. The biostimulator transport system of claim 1 further comprising an inner shaft extending through the elongated catheter body, wherein the wedge is coupled to the inner shaft, and wherein the inner shaft is slidable within the elongated catheter body to move the wedge relative to the elongated catheter body.

3. The biostimulator transport system of claim 1 further comprising a gripper housing mounted on the elongated catheter body, wherein the gripper is pivotably coupled to the gripper housing.

4. The biostimulator transport system of claim 3, wherein the gripper includes a pair of gripper jaws pivotably coupled to the gripper housing by respective hinge pins.

5. The biostimulator transport system of claim 4, wherein the pair of gripper jaws includes a first gripper jaw having a first recess to receive an attachment feature of a biostimulator when the gripper is in the grip state.

6. The biostimulator transport system of claim 5, wherein the pair of gripper jaws includes a second gripper jaw having a second recess, and wherein the first recess faces the second recess when the gripper is in the grip state.

7. The biostimulator transport system of claim 1, wherein the wedge includes a wedge hook, wherein the gripper includes a gripper hook, and wherein the wedge hook engages the gripper hook when the gripper is in the grip state.

8. A biostimulator transport system, comprising: an elongated catheter body; a gripper pivotably coupled to the elongated catheter body, wherein the gripper includes a slot extending in a longitudinal direction; and a pin movable within the slot, wherein retraction of the pin from the slot causes the gripper to pivot outward from a grip state to a release state.

9. The biostimulator transport system of claim 8 further comprising a gripper housing mounted on the elongated catheter body, wherein the gripper includes a pair of gripper jaws pivotably coupled to the gripper housing.

10. The biostimulator transport system of claim 9, wherein the pair of gripper jaws are pivotably coupled to the gripper housing by respective hinge pins.

11. The biostimulator transport system of claim 9, wherein the pair of gripper jaws includes a second gripper jaw having a second slot, and wherein the slot and the second slot form a longitudinal hole when the gripper is in the grip state.

12. The biostimulator transport system of claim 9, wherein the gripper includes a recess to receive an attachment feature of a biostimulator when the gripper is in the grip state.

13. The biostimulator transport system of claim 12, wherein the pair of gripper jaws includes a second gripper jaw having a second recess, and wherein the recess faces the second recess when the gripper is in the grip state.

14. The biostimulator transport system of claim 13, wherein the pin extends longitudinally through the slot and between the recess and the second recess when the gripper is in the grip state.

15. A biostimulator transport system, comprising: an elongated catheter body; a capsule mounted on the elongated catheter body, wherein the capsule includes a port extending in a distal direction through a distal capsule face from a cavity to a surrounding environment; and a shuttle slidable within the cavity, wherein the shuttle includes a pair of prongs longitudinally aligned with the port.

16. The biostimulator transport system of claim 15, wherein the capsule includes a receiving socket distal to the distal capsule face, wherein an interior surface of the capsule defines the receiving socket and has a distal cylindrical profile and a taper profile between the distal cylindrical profile and the distal capsule face.

17. The biostimulator transport system of claim 15, wherein the port has a non-circular profile.

18. The biostimulator transport system of claim 15 further comprising a spring in the cavity, and wherein the spring biases the shuttle in the distal direction.

19. The biostimulator transport system of claim 18 further comprising a release wire coupled to and extending proximally from the shuttle through the elongated catheter body.

20. The biostimulator transport system of claim 15, wherein the capsule includes an interior cavity surface surrounding the cavity, wherein the interior cavity surface has a groove, and wherein the shuttle includes a protrusion seated in the groove.