Adjustable and rotatable lead connector

Abstract

An adjustable rotary connector is configured to establish electrical communication between an implantable medical lead and a cable of an external test device while allowing rotation of the implantable medical lead relative to the cable. The coupling member includes a conductive pin. An adjustable slot is positioned within the pin and is configured to receive different sized lead connectors. A bearing is configured to facilitate rotation of the pin relative to the cable. An actuatable element surrounds at least a portion of the adjustable slot. The actuatable element is configured to transition between a first position and a second position relative to the adjustable slot to allow the adjustable slot to receive and secure the lead connector of the implantable medical lead in the adjustable slot.

Description

Technical Field

[0001] The present disclosure relates generally to medical devices, and more particularly to testing implantable medical leads during an implantation procedure. Background Art

[0002] Various types of implantable medical leads have been implanted for treating or monitoring one or more conditions in a patient. Such implantable medical leads may be adapted to allow a medical device to monitor or treat conditions or functions associated with the heart, muscles, nerves, brain, stomach, endocrine organs, or other organs and their associated functions. Implantable medical leads include electrodes and / or other elements for physiological sensing and / or therapeutic delivery. Implantable medical leads allow sensing / therapeutic elements to be positioned at one or more target locations to achieve these functions, while a medical device electrically coupled to these elements via the leads is at a different location.

[0003] Implantable medical leads may be implanted at target locations that are selected to detect a patient's physiological condition and / or deliver one or more therapies. For example, an implantable medical lead may be delivered to a location within the atrium or ventricle to sense intrinsic cardiac signals and deliver pacing or anti-tachyarrhythmic shock therapy from a medical device coupled to the lead. In other examples, an implantable medical lead may be tunneled to a location adjacent to the spinal cord or other nerves to deliver pain therapy from a medical device coupled to the lead. An implantable medical lead may include an anchoring component to secure the distal end of the lead at a target location. Summary of the invention

[0004] Guiding the distal electrode of an implantable medical lead to achieve sufficient depth within tissue (e.g., cardiac tissue of the ventricular septum) may be necessary for effective delivery of therapy. For example, in the case of left bundle branch area pacing (LBBAP) or other conduction system pacing (CSP), insufficient depth of the distal electrode may result in inadequate therapy, while excessive depth may result in perforation of the heart wall. In some examples, a clinician may use real-time electrical signals sensed via the distal electrode to determine the current position of the distal electrode within the tissue. Example electrical signals may include pacing impedance, signals indicating pacing capture, electrogram signals, and the like. One or more of these signals may indicate whether the position of the distal electrode is sufficient for a given therapy. For example, a real-time electrogram may provide great support in terms of operational safety and convenience during an implantation procedure for a CSP such as LBBAP.

[0005] In some cases, the entire implantable medical lead or a portion thereof is rotated during the implantation procedure (e.g., to advance a fixation member including a distal electrode into the patient's tissue, thereby securing the lead to the tissue). However, a test device for collecting signals from the distal electrode and its associated cabling may not be configured to rotate with the lead. For example, rotation of the lead may cause the cabling of the test device to become tangled, potentially interfering with the implantation procedure and / or introducing undesirable noise and resistance. In addition, the test device cabling may be incompatible with different types of lead interfaces (e.g., IS-1, DF-4, and IS-4). This may disadvantageously result in the physician being unable to obtain real-time electrogram signals based on the lead used during surgery, or require the physician to obtain and select from different test devices and / or cabling for different lead types.

[0006] An adjustable rotary connector according to the present disclosure may include features that maintain an electrical connection between an electrode of an implantable medical lead and a test device during rotation of the lead. In some examples, the adjustable rotary connector may reduce the presence of noise in a signal sensed by a distal electrode. These features may allow a clinician to continuously observe real-time electrical signals or data derived therefrom during rotation of the lead, which may reduce the time and effort required to identify the appropriate implantation location / depth of the distal electrode. In addition, a rotary connector according to the present disclosure may be configured to be adjustable to accommodate lead interfaces of different sizes associated with different types of leads.

[0007] In some examples, an adjustable swivel connector is configured to establish electrical connectivity between an implantable medical lead and a cable of an external testing device, wherein the adjustable swivel connector includes: a pin that is conductive; an adjustable slot that is conductive and configured to elastically deform to receive a lead connector of the implantable medical lead, wherein a proximal end of the slot is mechanically and electrically coupled to the pin to provide electrical connectivity between the pin and the lead connector, and wherein the adjustable slot is configured to receive lead connectors of different sizes; a bearing configured to facilitate rotation of the pin relative to the cable; an actuatable element that surrounds at least a portion of the slot and, when in a first position relative to the adjustable slot, disengages from the slot to allow the slot to elastically deform to receive the lead connector of the implantable medical lead; and, when in a second position relative to the adjustable slot, engages the adjustable slot to secure the lead connector of the implantable medical lead in the slot.

[0008] In some examples, a system includes: an implantable medical lead, the implantable medical lead including: a distal electrode; and a lead connector; a cable, the cable being electrically connected to an external testing device; an adjustable swivel connector, the adjustable swivel connector being configured to establish electrical communication between the implantable medical lead and the cable, the adjustable swivel connector including: a pin, the pin being conductive; an adjustable slot, the adjustable slot being conductive and configured to elastically deform to receive the lead connector of the implantable medical lead, wherein a proximal end of the slot is mechanically and electrically coupled to the pin to provide the The invention relates to a method of manufacturing a medical lead wire connector for implantable medical lead wires and a method of manufacturing a medical lead wire connector for implantable medical lead wires. The method comprises: providing electrical communication between the pin and the lead connector, and wherein the adjustable slot is configured to receive lead connectors of different sizes; a bearing configured to facilitate rotation of the pin relative to the cable; an actuatable element that surrounds at least a portion of the slot and, when in a first position relative to the adjustable slot, disengages from the slot to allow the slot to elastically deform to receive the lead connector of the implantable medical lead; and, when in a second position relative to the adjustable slot, engages the adjustable slot to secure the lead connector of the implantable medical lead in the slot.

[0009] In some examples, a method includes: surrounding at least a portion of an adjustable slot of an adjustable swivel connector with an actuatable element, wherein the adjustable swivel connector is configured to establish electrical communication between an implantable medical lead and a cable of an external testing device, wherein the adjustable slot is electrically conductive and configured to elastically deform to receive a lead connector of the implantable medical lead, wherein a proximal end of the slot is mechanically and electrically coupled to a pin of the adjustable swivel connector to provide electrical communication between the pin and the lead connector, and wherein the adjustable slot is configured to receive different sizes of A lead connector; when changing from a second position relative to the adjustable slot to a first position relative to the adjustable slot, the actuatable element mechanically disengages the adjustable slot to allow the adjustable slot to elastically deform to receive the lead connector of the implantable medical lead; when changing from the second position relative to the adjustable slot to the first position relative to the adjustable slot, the actuatable element mechanically engages the adjustable slot to fix the lead connector of the implantable medical lead in the slot; and the bearing of the adjustable swivel connector causes the pin to rotate relative to the cable.

[0010] In some examples, an adjustable swivel connector is configured to electrically couple an implantable medical lead and an external test device while allowing axial rotation of the lead relative to the external test device, wherein the adjustable swivel connector includes: a stator configured to be connected to the external test device via a cable, the stator including an inner recess; a rotor received within the inner recess of the stator; and at least one bearing, the at least one bearing being within the inner recess of the stator, the at least one bearing being configured to facilitate relative rotation between the stator and the rotor along a longitudinal axis, wherein the rotor includes: an adjustable slot that is electrically conductive and configured to elastically deform to A lead connector for receiving the implantable medical lead, wherein the slot is electrically coupled to the cable, and wherein the adjustable slot is configured to receive lead connectors of different sizes; and an actuatable element that moves around at least a portion of the slot and along the longitudinal axis to transition between a first position and a second position relative to the slot, wherein: when in the first position relative to the adjustable slot, it disengages from the slot to allow the slot to elastically deform to receive the lead connector of the implantable medical lead; and when in the second position relative to the adjustable slot, it engages with the adjustable slot to position the lead connector of the implantable medical lead in the slot.

[0011] The present disclosure is intended to provide an overview of the subject matter described in the present disclosure. The present disclosure is not intended to provide an exclusive or exhaustive explanation of the systems, devices, and methods described in detail in the following figures and description. Further details of one or more examples of the present disclosure are set forth in the following figures and description. Other features, objectives, and advantages will be apparent from the description and drawings, as well as from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a conceptual diagram illustrating an example medical device system according to the techniques of this disclosure.

[0013] Figure 2 is a conceptual diagram illustrating an example system for testing the depth of a distal electrode of an implanted medical lead in accordance with the techniques of this disclosure.

[0014] Figure 3A is a cross-sectional view illustrating an example adjustable rotary connector in accordance with the techniques of this disclosure.

[0015] Figure 3B According to the technology disclosed in this invention Figure 3A An exploded view of an adjustable rotary connector including a stator and a rotor.

[0016] Figure 3C According to the technology disclosed in this invention Figure 3BExploded view of the stator.

[0017] Figure 3D According to the technology disclosed in this invention Figure 3C Exploded view of the rotor.

[0018] Figure 4A is a cross-sectional view illustrating a portion of an example adjustable rotary connector having an increased inner diameter in accordance with the presently disclosed technology.

[0019] Figure 4B is a cross-sectional view illustrating a portion of an example adjustable rotary connector having a reduced inner diameter in accordance with the presently disclosed technology.

[0020] Figure 5A is a cross-sectional view illustrating a portion of an example adjustable swivel connector and an example lead connector in accordance with the presently disclosed techniques.

[0021] Figure 5B is a cross-sectional view illustrating a portion of an example adjustable swivel connector and an example lead connector in accordance with the presently disclosed techniques.

[0022] Figure 6 is a flow chart illustrating an example technique for coupling leads to an adjustable swivel connector.

[0023] Figure 7 is a flow chart illustrating an example technique for testing an implantable medical lead during an implantation procedure using an adjustable swivel connector. DETAILED DESCRIPTION

[0024] Figure 1 is a conceptual diagram illustrating an example medical device system 100 (“system 100”) for delivering a CSP, such as LBBAP, to a heart 102 of a patient 104. Figure 1 As shown in the example system 100 in , system 100 may include an implantable medical device 108 (“IMD 108”) having cardiac pacing capabilities. IMD 108 is connected to an implantable medical lead 110 (“lead 110”) that includes a lead body 112 that extends from a proximal portion 114 of lead 110 (“lead proximal portion 114”) to a distal portion 116 of lead 110 (“lead distal portion 116”). Lead proximal portion 114 may be operably coupled to IMD 108. Although primarily described herein with respect to LBBAP, the techniques of the present disclosure may be applied to other areas of the heart, including other parts of the conduction system of the heart, such as the His-Purkinje conduction system (HPCS) or the right bundle branch (RBB). In addition, although primarily described herein in the context of cardiac pacing, the techniques of the present disclosure may be applied to non-cardiac contexts, such as neural stimulation.

[0025] IMD 108 may sense electrical signals accompanying depolarization and repolarization of heart 102, such as cardiac EGMs, via electrodes on lead 110 and / or a housing of IMD 108. IMD 108 may also deliver therapy to heart 102 in the form of electrical signals (e.g., cardiac pacing) via electrodes located on lead 110. In the illustrated example, lead 110 includes distal electrode 118A at lead distal portion 116 and proximal electrode 118B located proximal to distal electrode 118A (collectively referred to as "electrode 118"). In other examples, lead 110 may include more or fewer electrodes 118, such as an example in which lead 110 includes only electrode 118A.

[0026] Leads 110 may extend into the heart 102 of the patient 104 to sense electrical activity of the heart 102 and / or deliver electrical stimulation to the heart 102. Figure 1 In the example shown, lead 110 extends through one or more veins (not shown), the superior vena cava (not shown), the right atrium, and into cardiac tissue at the interventricular septum. System 100 may include additional leads coupled to IMD 108, such as a left ventricular (LV) lead that extends through one or more veins, the vena cava, the right atrium, and into the coronary sinus to a region adjacent to the free wall of the left ventricle of heart 102 and / or a lead that extends into the right atrium.

[0027] Lead 110 (e.g., distal electrode 118A) can be positioned to provide pacing to the LBB. Providing pacing to the LBB is sometimes referred to as "LBBAP" or "LBBP." In the illustrated example, distal electrode 118A is positioned within the heart tissue of the ventricular septum. In other examples, lead 110 and distal electrode 118A can be implanted at a location that provides pacing to other parts of heart 102, such as the HPCS or RBB.

[0028] In some examples, the distal electrode 118A may be carried by the distal end of the lead 110. In addition to having electroactive properties, the distal electrode 118A may be configured to grasp tissue at or near the target site and substantially fix the distal end of the lead 110 to the target site. In other words, the distal electrode 118A may be configured to substantially maintain the orientation of the lead 110 relative to the target site by penetrating the tissue. That is, in some examples, the distal electrode 118A may be, include, or be included in a fixing member. For example, the distal electrode 118A may be a non-insulated portion of the fixing member. In some examples, the distal electrode 118A may include one or more fixing tines of any shape, including but not limited to fixing tines of a spiral shape. For example, the distal electrode 118A may take the form of a fixing spiral, a tined tip electrode, etc.

[0029] Electrode 118B may take the form of a ring electrode that is electrically insulated from electrode 118A. In some examples, distal electrode 118A may be positioned within cardiac tissue such that pacing stimulation delivered via distal electrode 118A activates LBB. During an implantation procedure for lead 110, an implanting physician may position the distal end of lead 110 at a desired location and secure distal electrode 118A, distal to the distal end of lead 110, to a desired depth within cardiac tissue (e.g., the ventricular septum).

[0030] Lead 110 may include a lead electrical connector 120 (sometimes referred to herein as "connector 120" or "lead connector 120"), such as an IS-1 connector, a DF-4 connector, or an IS-4 connector, configured to establish electrical communication between IMD 108 and electrode 118. Connector 120 may be configured to be in electrical communication with circuitry of IMD 108. Connector 120 includes one or more conductors (not shown) configured to be in electrical communication with electrode 118. In some examples, each of electrodes 118A and 118B is electrically coupled to a corresponding conductor within connector 120, and thereby coupled to circuitry within IMD 108. In examples, connector 120 is configured such that electrical communication with distal electrode 118A and proximal electrode 118B occurs substantially independently, e.g., to facilitate proper placement of electrode 118 and / or to obtain a better electrical signal (lower threshold, lower impedance, etc.).

[0031] As described in more detail below, placement of CSP leads may pose particular challenges to ensuring proper location and depth of electrode 118A (e.g., rotation of the lead including the distal helix) to capture a portion of the CS. Conventional alligator clips used to electrically connect the lead to a test device during implantation to test electrical adequacy of implantation depth may similarly cause challenges and delays in the implantation process involving lead rotation. Furthermore, different commercial leads may have different connectors, which in turn may have different sizes. Therefore, some commercial leads may be incompatible with certain test systems.

[0032] Figure 2 is a conceptual diagram illustrating an example system 222 for testing an implantable medical lead 210 ("lead 210") during an implantation procedure. Lead 210 may be substantially similar to Figure 1 The lead wire 110 is shown. Figure 2As shown in the example of , the system 222 includes a test device 224 connected to the lead 210 via a first cable 226. More specifically, the first cable 226 includes an adjustable swivel connector 228, which is configured to selectively physically and electrically connect the first cable 226 to the lead connector 220. The system 222 also includes an auxiliary electrode 230, which can be externally attached to the patient, for example, via an adhesive patch. The auxiliary electrode 230 can be connected to the test device 224 via a second cable 232.

[0033] The adjustable rotary connector 228 can be configured to allow the lead 210 to rotate relative to the first cable 226 while maintaining an electrical connection between the test device 224 and the distal electrode 218A. For example, the adjustable rotary connector 228 can include a rotary coupling (e.g., a rotor). The adjustable rotary connector 228 can be configured to be electrically connected to the distal electrode 218A and the test device 224. For example, the adjustable rotary connector 228 can be configured to conduct an electrocardiogram signal in which left bundle branch tissue features can be detected during rotation of the lead 210. In another example, the adjustable rotary connector 228 can be configured to conduct an electrocardiogram signal in which His-Purkinje conduction system features can be detected during rotation of the lead 210.

[0034] Lead 210 may include a first conductor 236 electrically connected to distal electrode 218A and a second conductor 238 electrically connected to proximal electrode 218B. First conductor 236 may be electrically connected to adjustable swivel connector 228. First cable 226 includes a third conductor 240 that is electrically connected or connectable to both adjustable swivel connector 228 and lead connector 220 and test device 224 via adjustable swivel connector 228. When lead 210, adjustable swivel connector 228, first cable 226, and test device 224 are connected, first conductor 236 and third conductor 240 electrically connect distal electrode 218A to test device 224. Auxiliary electrode 230 is also connected or connectable to test device 224 via conductor 242 of second cable 232. In the illustrated example, adjustable swivel connector 228 is configured to electrically connect one electrode (distal electrode 218A) of lead 210 to test device 224 in a monopolar configuration via first cable 226. In other examples, the adjustable swivel connector 228 and the testing device 224 may be connected to the two electrodes 218 of the lead 210 in a bipolar configuration, and the auxiliary electrode 230 and the second cable 232 may be omitted.

[0035] The test device 224 receives one or more signals sensed using the distal electrode 218A, wherein the auxiliary electrode 230 acts as a reference electrode. In some examples, the test device 224 measures a pacing impedance signal using the distal electrode 218A. In some examples, the test device 224 receives a cardiac EGM signal sensed using the distal electrode 218A, wherein the auxiliary electrode 230 acts as a reference electrode. The implantation physician may use the signal and / or a value derived from the signal to determine whether the current position / depth of the distal electrode 218A is sufficient for sensing and therapy delivery by the IMD 108 via the distal electrode 218A. In the case of LBBAP pacing, for example, the presence of an LBB feature (e.g., a feature indicating electrical activity of the LBB) in the cardiac EGM may indicate an appropriate position / depth of the distal electrode 218A.

[0036] In some cases, the lead 210 (or a portion thereof) is rotated during the implantation procedure (e.g., to secure the lead 210). However, the test device 224, the first cable 226, and the second cable 232 may not be able to rotate with the lead 210 (e.g., not entangled). In addition, the rotation of the lead 210 may introduce artifacts or other noise into the signal used to determine whether its position / depth is appropriate. For example, the relative rotation of a portion of the conductive path may introduce noise, such as due to an on / off event that occurs during the relative rotation. The noise may corrupt the signal, making it impossible to determine the appropriateness of the position / depth of the electrode 218A during the rotation. According to the technology disclosed herein, the adjustable swivel connector 228 may allow relative rotation of the lead 210 and the first cable 226, and reduce the noise associated with such rotation.

[0037] Figure 3A is a cross-sectional view illustrating an example adjustable rotary connector 328. The adjustable rotary connector 328 may be substantially similar to Figure 2 The adjustable rotating connector 228 is shown. According to the technology of the present disclosure, the rotating electrically adjustable rotating connector 328 can not only establish electrical communication between the implantable medical lead 310 ("lead 310") and the test device 324, but also facilitate the rotation between the lead 310 and the test device 324. The lead 310 can be substantially similar to Figure 1 The leads 110 and / or Figure 2 Lead 210 shown in FIG. 1 , and test device 324 can be substantially similar to test device 224. In addition, according to the technology of the present disclosure, adjustable swivel connector 328 can be configured to couple to a variety of lead connector types, including but not limited to IS-1 connectors, DF-4 connectors, and IS-4 connectors. Therefore, adjustable swivel connector 328 can achieve compatibility with pacing leads of different sizes and electrical transmissions while rotating with little resistance.

[0038] like Figure 3AAs shown, the adjustable swivel connector 328 includes a connector body 344. The connector body 344 can be formed of polyetheretherketone (PEEK) or other insulating materials. The connector body 344 can be configured to at least partially accommodate (e.g., mechanically support, receive, etc.) an adjustable lead connector slot 346 ("slot 346"), a pin 348, one or more bearings 350 ("bearings 350") that can be insulating or conductive, an elastically deformable member 352, an actuatable element 354, and an electrical contact structure 356 ("contact structure 356").

[0039] The slot 346 may be configured to receive the proximal end 334 of the lead connector 320, in such a way as to establish electrical communication with one or more electrodes of the lead 310 (e.g., the distal electrode of the lead). The slot 346 may be conductive. The slot 346 may be formed of a conductive material such as copper, silver, gold, etc. The slot 346 may be configured to elastically deform (e.g., in response to contraction). For example, the slot 346 may have a structure that is easily contracted by one or more applied forces. In some examples, and as shown in FIG. 3 , the slot 346 may define one or more notches 358 (e.g., notches, slots, slits, channels, etc.) that allow the slot 346 to elastically deform to receive the lead connector 320. For example, the slot 346 may define one or more slits extending axially along the slot 346 from the distal end of the slot 346, so that the distal portion 360 of the adjustable slot 346 can be elastically deformed radially. The slot 346 may return to a normal shape, such as a non-contracted shape, after elastic deformation according to the technology disclosed herein.

[0040] The actuatable element 354 of the adjustable swivel connector 328 may surround at least a portion of the slot 346. For example, the actuatable element 354 may define a channel in which the slot 346 and the elastically deformable member 352 are at least partially positioned. The actuatable element 354 may be configured to engage and disengage the slot 346. The engagement of the actuatable element 354 with the slot 346 may be mechanical, electrical, etc. The disengagement of the actuatable element 354 from the slot 346 may be mechanical, electrical, etc. In some examples, the actuatable element 354 may be moved, rotated, pulled, pressed, etc. in a mechanical or electrical manner to engage and disengage the slot 346. For example, a clinician may mechanically move, rotate, pull, press, etc. the actuatable element 354 to engage and disengage the slot 346.

[0041] The actuable element 354 can be configured to disengage from the slot 346 when in a first position relative to the slot 346 to allow the slot 346 to receive the lead connector 320. For example, the clinician can move the actuable element 354 to the first position by compressing the elastically deformable member 352 in the proximal direction (indicated by the "P" arrow). When in the first position, the actuable element 354 can disengage from the distal portion 360 of the slot 346, thereby allowing the inner diameter of at least the distal portion 360 of the slot 346 to increase. When the actuable element 352 is in the first position, the slot 346 can be configured to receive lead connectors of IS-1 connector, DF-4 connector and IS-4 lead connector size configurations. In this way, the slot 346 can be configured to receive lead connectors of different sizes, such as lead connectors with an inner diameter between about 0.5 millimeters (mm) and about 3 mm and a length between about 3 mm and 8 mm.

[0042] Slot 346 may be configured to secure lead connector 320. For example, once lead connector 320 is positioned within slot 346, actuatable element 354 may be configured to be engaged to slot 346 when in a second position relative to slot 346 to elastically deform slot 346 to secure lead connector 320 in slot 346. In some examples, elastically deformable member 352 may be configured to provide a biasing force to move actuatable element 354 to the second position. For example, a clinician may release actuatable element 354. Thus, elastically deformable member 352 may extend in a distal direction (indicated by "D" arrow) such that actuatable element 352 engages (e.g., contacts) distal portion 360 of slot 346. Contact between actuatable element 352 and slot 346 may cause slot 346 to be radially compressed onto lead connector 320. As such, the socket 346 may be clamped down onto at least a portion of the lead connector 320, thereby securing the lead connector 320 within the socket 346 and ensuring electrical contact therebetween.

[0043] Pin 348 can be configured to be coupled to slot 346. For example, the proximal end of slot 346 can be mechanically and electrically coupled to pin 348 to provide electrical communication between pin 348 and lead connector 320. In some examples, pin 348 can include a pin base 362 ("base 362") and a pin tip 364 ("tip 364"). Base 362 can define a recess. At least one segment of slot 346 can be positioned or otherwise disposed within the recess of pin 348. Tip 364 can contact contact structure 356. Pin 348 can be conductive. For example, both base 362 and tip 364 can be conductive. Base 362 and tip 364 can be formed of a conductive material.

[0044] The bearing 350 can be configured to facilitate rotation of the pin 348 (and thus the socket 346 and the lead 310) relative to the first cable 326. For example, an inner rotating component of the bearing 350 can be fixed to the pin 348, while an outer rotating component of the bearing 350 can be fixed to the connector body 344. The bearing 350 can be configured so that the inner rotating component of the bearing 350 can rotate freely (e.g., with little resistance) relative to the outer rotating component.

[0045] The contact structure 356 can be configured to establish electrical communication between the pin 348 and the first cable 326. The contact structure 356 can be formed of a conductive material. As shown in FIG. 3, the first cable 326 is in electrical contact with the contact structure 356. As further shown in FIG. 3, the tip 364 of the pin 348 is in electrical contact with the contact structure 356. The pin 348 can rotate relative to the contact structure 356 along the longitudinal axis 365.

[0046] In some examples, pin 348 may include a pin bearing (e.g., an elastically deformable member such as a spring). The pin bearing may be configured to achieve stable signal transmission from lead connector 320 to first cable 326 (e.g., by reducing the extent of axial movement of tip 364 of pin 348 during rotation of lead 310). In this way, adjustable rotation connector 328 may mitigate noise that may otherwise be introduced into the signal received by test device 324.

[0047] Figure 3B yes Figure 3A An exploded view of the adjustable swivel connector 328 is shown. Figure 3B As shown, adjustable rotary connector 328 includes stator 366 and rotor 368. Stator 366 can be configured to be rotationally fixed relative to test device 324. For example, when lead 310 rotates, stator 366 may not rotate with lead 310, but remain substantially stationary. Rotor 368 can be configured to be rotationally fixed relative to lead 310 and rotate relative to stator 366. For example, when lead 310 rotates, rotor 368 can rotate with lead 310 (so that rotor 368 rotates relative to stator 366 and then rotates relative to test device 324).

[0048] Figure 3C is an exploded view of the stator 366. Figure 3CAs shown, the stator 366 includes various components. For example, the stator 366 may include the first cable 326, the contact structure 356, the proximal connector body component 345A, the distal connector body component 345B (collectively referred to as "connector body component 345"), the first insulating bearing 350A and the second insulating bearing 350B (collectively referred to as "bearing 350"). The connector body 344 including the connector body component 345 can be configured to accommodate the various components of the stator 366. The stator 366 can be configured to be rotationally fixed relative to the test device 324. For example, when the lead 310 rotates, the stator 366 may not rotate with the lead 310, but remain substantially stationary.

[0049] Figure 3D is an exploded view of rotor 368. Figure 3D As shown, rotor 368 includes a variety of components. For example, stator 368 may include tip 364, insulating support 370, pin biasing member 372 ("biasing member 372"), base 362, slot 346, elastically deformable member 352, actuatable element assembly 374, and actuatable element 354. Insulating support 370 may be configured to accommodate at least a portion of tip 364, biasing member 372, and base 362. Actuatable element assembly 374 may be configured to accommodate at least a portion of actuatable element 354.

[0050] Pin 348 may include a base 362 and a tip 364. Pin 348 may be configured to rotate relative to contact structure 356. For example, pin 348 may be positioned within bearing 350 and operatively coupled to the bearing. In this manner, pin 348 may rotate with the implantable medical lead while contact structure 356 remains stationary. Additionally, tip 364 of pin 348 may be in electrical contact with contact structure 356.

[0051] In some examples, pin 348 can include a biasing member 372 (e.g., an elastically deformable member such as a spring). Biasing member 372 can be configured to force tip 364 against contact structure 356. By reducing axial movement of tip 364 in this manner, biasing member 372 can help achieve stable signal transmission during rotation of lead 310. Thus, adjustable rotary connector 328 can mitigate noise that might otherwise be introduced into a signal received by a test device.

[0052] FIG. 4A to FIG. 4B is a cross-sectional view illustrating a portion of an example adjustable rotary connector 428. The adjustable rotary connector 428 may be substantially similar to Figure 2 The adjustable swivel connector 228 shown in FIG. 3 and / or the adjustable swivel connector 328 shown in FIG. FIG. 4A to FIG. 4BAs shown, the adjustable swivel connector 428 includes a slot 446 , an elastically deformable member 452 , and an actuatable element 454 . Figure 4A Actuatable element 454 is shown in a first position relative to slot 446. When actuatable element 454 is in the first position, adjustable swivel connector 428 can be configured to receive a lead connector (eg, lead connector 320). Figure 4B Actuatable element 454 is shown in a second position relative to slot 446. When actuatable element 454 is in the second position, adjustable swivel connector 428 can be configured to secure the lead connector.

[0053] As noted above, adjustable swivel connector 428 may be compatible with a variety of lead connector sizes. For example, slot 446 may be elastically deformable such that an inner diameter (indicated by "ID") of slot 446 may be adjustable, thereby allowing insertion and engagement of a lead connector (e.g., lead connector 320) within slot 446. In some examples, actuatable element 454 may be configured to interact with slot 446 and elastically deformable member 452 to facilitate changes in the inner diameter of slot 446.

[0054] Slot 446 and resiliently deformable member 452 may be at least partially positioned within channel 464 of actuatable element 454. In some examples, portion 466 of channel 464 is sized such that when actuatable element 454 is in a second position relative to slot 446, a wall defining portion 466 engages (e.g., contacts) slot 446 to radially compress slot 446 onto a lead connector (e.g., lead connector 320). FIG. 4A to FIG. 4B As shown, the wall can be tapered so that distal movement of the compression member 454 relative to the slot 446 causes radial contraction of the slot 446.

[0055] In some examples, at least one section of portion 466 may have an inner diameter that is smaller than an inner diameter of the channel 464 immediately distal to such section of portion 466, such that when actuatable element 454 is in a first position relative to slot 446, the wall is disengaged from slot 446. In response to the clinician moving actuatable element 454 in a proximal direction (indicated by the "P" arrow), actuatable element 454 may transition from a second position relative to slot 446 to a first position relative to slot 446. Figure 4A As shown, when actuatable element 454 is in the first position, actuatable element 454 no longer radially contracts socket 446, thereby allowing the inner diameter of socket 446 to increase. When in this increased inner diameter configuration, socket 446 can have an inner diameter sized to receive a variety of lead connector sizes.

[0056] When actuatable element 454 is in the first position, elastically deformable member 452 may be compressed and provide a biasing force to move actuatable element 454 to the second position. For example, the clinician may release actuatable element 454 (e.g., after inserting lead connector 320 into slot 446), and elastically deformable member 452 may then expand in the distal direction (indicated by the "D" arrow) so that the wall defining portion 466 is engaged to slot 446 to radially compress slot 446 onto the lead connector, thereby securing the lead connector within slot 446.

[0057] Figure 5A is a cross-sectional view illustrating a portion of an example adjustable swivel connector 528A and lead connector 520A. Figure 5B is a cross-sectional view illustrating a portion of an example adjustable rotary connector 528B and a lead connector 520B. Adjustable rotary connectors 528A-528B (collectively referred to as "adjustable rotary connectors 528") are substantially similar to Figure 2 3, and / or the adjustable swivel connector 428 shown in FIG. 4. Lead connector 520A and lead connector 520B (collectively referred to as "lead connectors 520") are substantially similar to Figure 2 The lead connector 220 shown and / or the lead connector 320 shown in FIG. 3 .

[0058] Generally speaking, an adjustable swivel connector (e.g., adjustable swivel connector 528) according to the disclosed technology can be configured to be compatible with a variety of lead connectors (e.g., lead connector 520). That is, in some examples, the slot can be customized to improve engagement with the lead connector. For example, Figure 5A The slot 546A of the distal portion 560A is illustrated as having a uniform inner diameter. The uniform inner diameter of the distal portion 560A can allow for greater grip of the lead connector 520A, which is Figure 5A In another example, Figure 5B A slot 546B is illustrated having a distal end portion 560B having one or more features extending from an inner surface of the distal end portion 560B. These features can be configured to contact the lead connector 520B when the lead connector 520B is secured by the slot 546B.

[0059] Figure 6 is a flow chart illustrating an example technique for coupling a lead to an adjustable rotary connector. Figure 6 However, Figure 6 The techniques may be applied to any device or combination of devices described herein.

[0060] The actuatable element 354 can be moved to a first position (600) relative to the slot 346. For example, the clinician can move the actuatable element 354 to the first position by compressing the elastically deformable member 352 in the proximal direction (indicated by the "P" arrow). When in the first position, the actuatable element 354 can be disengaged from the distal portion 360 of the slot 346, thereby allowing the inner diameter of at least the distal portion 360 of the slot 346 to increase.

[0061] When the actuatable element 352 is in the first position, the slot 346 can receive the lead connector 320 (602). The lead connector 320 can be, for example, a DF-4 connector or an IS-4 lead connector.

[0062] Socket 346 may be moved to a second position relative to socket 346 (604). For example, elastically deformable member 352 may provide a biasing force to move actuatable element 354 to the second position such that actuatable element 352 engages (e.g., contacts) distal portion 360 of socket 346. Contact between actuatable element 352 and socket 346 may cause socket 346 to be radially compressed onto lead connector 320. In this manner, socket 346 may be clamped down onto at least a portion of lead connector 320, thereby securing lead connector 320 within socket 346 and ensuring electrical contact therebetween.

[0063] Figure 7 is a flow chart illustrating an example technique for testing a lead during an implantation procedure using an adjustable swivel connector. Figure 7 However, Figure 7 The techniques may be applied to any device or combination of devices described herein.

[0064] The test device 224 may be electrically connected to the rotationally electrically adjustable rotary connector 328 (700). In some examples, the test device 224 includes the adjustable rotary connector 228 or another connector configured to engage a portion of the rotationally electrically adjustable rotary connector 228 (such as the first conductive component 60A). In this manner, the distal electrode 218A of the lead 210 is electrically connected to the test device 224 via the rotationally electrically adjustable rotary connector 228 as described herein.

[0065] The distal electrode 218A of the lead 210 can be positioned adjacent to the cardiac tissue (e.g., the ventricular septum) at a desired location for sensing and therapy delivery (e.g., for LBBAP). With the distal electrode 218A electrically connected to the test device 224 and positioned as desired relative to the cardiac tissue, the test device 224 can begin measuring impedance and sensing cardiac EGMs via the distal electrode 218A (702). Once initiated, the measurements and sensing performed by the test device 224 may be substantially continuous, for example, at a certain sampling rate and at multiple locations / depths of the distal electrode 218A during a time period including multiple cardiac cycles. While the test device 224 measures or senses one or more signals, the lead 210 or a portion thereof can be rotated to advance the distal electrode 218A within the cardiac tissue (704). In some cases, the distal electrode 218A can be additionally repositioned to different entry points of the cardiac tissue and trajectories through the cardiac tissue.

[0066] Based on the output of the test device 224 (which is based on one or more signals obtained via the distal electrode 218A), the implanting physician can determine whether the current position / depth of the distal electrode 218A is sufficient for sensing and therapy delivery (706). If the current position / depth is not appropriate (No of 706), the physician can continue to rotate the lead 210 relative to the heart tissue while the test device 224 continues to acquire one or more signals via the distal electrode 218A. If the current position / depth is appropriate (Yes of 706), the physician can end the implantation procedure and that portion of the lead 210 (708).

[0067] The techniques described in the present disclosure may be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques may be implemented in one or more processors or processing circuits, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuits, and any combination of such components. The term "processor" or "processing circuit" may generally refer to any of the aforementioned logic circuits, either alone or in combination with other logic circuits, or any other equivalent circuit. A control unit including hardware may also perform one or more of the techniques of the present disclosure.

[0068] Such hardware, software, and firmware may be implemented in the same device or in separate devices to support the various operations and functions described in this disclosure. In addition, any described units, circuits, or components may be implemented together, or independently as discrete but interoperable logic devices. Describing different features as circuits or units is intended to highlight different functional aspects, and does not necessarily imply that such circuits or units must be implemented by separate hardware components or software components. On the contrary, the functions associated with one or more circuits or units may be performed by separate hardware components or software components, or integrated in common or separate hardware components or software components.

[0069] The techniques described in the present disclosure may also be embodied or encoded in a computer-readable medium (such as a computer-readable storage medium) containing instructions, which may be described as a non-transitory medium. The instructions embedded or encoded in the computer-readable storage medium may cause a programmable processor or other processor to perform the method, for example, when executing these instructions. The computer-readable storage medium may include a random access memory (RAM), a read-only memory (ROM), a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, a magnetic medium, an optical medium, or other computer-readable medium.

[0070] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. An adjustable swivel connector configured to establish electrical communication between an implantable medical lead and a cable of an external testing device, wherein the adjustable swivel connector comprises: A pin, wherein the pin is conductive; an adjustable socket that is electrically conductive and configured to elastically deform to receive a lead connector of the implantable medical lead, wherein a proximal end of the adjustable socket is mechanically and electrically coupled to the pin to provide electrical communication between the pin and the lead connector, and wherein the adjustable socket is configured to receive lead connectors of different sizes; a bearing configured to facilitate rotation of the pin relative to the cable; an actuatable element surrounding at least a portion of the adjustable slot, wherein the actuatable element is configured to: the lead connector disengaging from the adjustable slot to allow the adjustable slot to elastically deform to receive the implantable medical lead when in a first position relative to the adjustable slot; as well as The lead connector engages the adjustable slot to secure the implantable medical lead in the adjustable slot when in a second position relative to the adjustable slot.

2. The adjustable swivel connector of claim 1 , further comprising an electrical contact structure configured to establish electrical communication between the pin and the cable, wherein the pin is rotatable relative to a contact surface along a longitudinal axis, and wherein the pin comprises: a pin base defining a recessed portion; Pin tip; and A pin biasing member is configured to urge the pin tip against the contact surface.

3. The adjustable swivel connector of any one of claims 1 to 2, wherein the adjustable slot is configured to receive a lead connector of an IS-1 connector, a DF-4 connector, and an IS-4 lead connector size configuration.

4. An adjustable swivel connector according to any one of claims 1 to 3, wherein the actuatable element defines a channel, the adjustable slot and the elastically deformable member are at least partially positioned in the channel, wherein the elastically deformable member is configured to provide a biasing force to move the actuatable element to the second position, and wherein a portion of the channel is sized so that when the actuatable element is in the second position relative to the adjustable slot, a wall defining the portion of the channel is engaged with the adjustable slot to radially compress the adjustable slot onto the lead connector.

5. The adjustable swivel connector according to claim 4, wherein the elastically deformable member is a spring.

6. An adjustable swivel connector according to claim 4 or 5, wherein at least one section of the portion of the channel has an inner diameter that is smaller than the inner diameter of the channel immediately distal to the section, so that the wall disengages from the adjustable slot when the actuatable element is in the first position relative to the adjustable slot.

7. The adjustable swivel connector according to any one of claims 1 to 6, wherein the inner diameter of the distal portion of the adjustable slot is uniform.

8. An adjustable swivel connector according to any one of claims 1 to 6, wherein the adjustable slot further comprises one or more features extending from an inner surface of the adjustable slot, wherein the one or more features are configured to contact the lead connector when the lead connector is secured by the adjustable slot.

9. The adjustable swivel connector according to any one of claims 1 to 8, wherein the adjustable slot defines one or more notches, the one or more notches allowing the adjustable slot to elastically deform to receive the lead connector.

10. The adjustable swivel connector according to claim 9, wherein the one or more notches comprise one or more slits extending axially along the adjustable slot from the distal end of the adjustable slot so that the distal portion of the adjustable slot can be elastically deformed radially.

11. A system, comprising: An implantable medical lead, comprising: a distal electrode; and Lead connector; a cable in electrical communication with an external testing device; An adjustable swivel connector configured to establish electrical communication between the implantable medical lead and the cable, the adjustable swivel connector comprising: A pin, wherein the pin is conductive; an adjustable slot that is electrically conductive and configured to elastically deform to receive the lead connector of the implantable medical lead, wherein a proximal end of the slot is mechanically and electrically coupled to the pin to provide electrical communication between the pin and the lead connector, and wherein the adjustable slot is configured to receive lead connectors of different sizes; a bearing configured to facilitate rotation of the pin relative to the cable; an actuatable element surrounding at least a portion of the adjustable slot, wherein the actuatable element is configured to: the lead connector disengaging from the slot to allow the slot to elastically deform to receive the implantable medical lead when in a first position relative to the adjustable slot; and The lead connector engages the adjustable slot to secure the implantable medical lead in the slot when in a second position relative to the adjustable slot.

12. The system of claim 11, wherein the adjustable swivel connector is configured to conduct an electrocardiogram signal in which left bundle branch tissue features can be detected during rotation of the implantable medical lead.

13. The system of claim 11 or 12, wherein the adjustable swivel connector is configured to conduct an electrocardiogram signal, and left bundle branch tissue characteristics can be detected in the electrocardiogram signal during rotation of the implantable medical lead.

14. The system of any one of claims 11 to 13, wherein the adjustable swivel connector is configured to conduct an electrocardiogram signal in which a His-Purkinje conduction system characteristic can be detected during rotation of the implantable medical lead.

15. The system of any one of claims 11 to 14, further comprising an electrical contact structure configured to establish electrical communication between the pin and the cable, wherein the pin is rotatable relative to a contact surface along a longitudinal axis, and wherein the pin comprises: a pin base defining a recessed portion; Pin tip; and A pin biasing member is configured to urge the pin tip against the contact surface.

16. The system of any one of claims 11 to 15, wherein the adjustable slot is configured to receive a lead connector of an IS-1 connector, a DF-4 connector, and an IS-4 lead connector size configuration.

17. A system according to any one of claims 11 to 16, wherein the actuatable element defines a channel, the adjustable slot and the elastically deformable member are at least partially positioned in the channel, wherein the elastically deformable member is configured to provide a biasing force to move the actuatable element to the second position, and wherein a portion of the channel is sized such that when the actuatable element is in the second position relative to the adjustable slot, a wall defining the portion is engaged to the adjustable slot to radially compress the adjustable slot onto the lead connector.

18. A system according to any one of claims 11 to 17, wherein at least one segment of the portion has an inner diameter that is smaller than the inner diameter of the channel immediately distal to the segment, so that the wall disengages from the adjustable slot when the actuatable element is in the first position relative to the adjustable slot.

19. The adjustable swivel connector of any one of claims 11 to 18, wherein the adjustable slot defines one or more notches that allow the slot to elastically deform to receive the lead connector.

20. A method comprising: at least a portion of an adjustable slot of an adjustable swivel connector surrounded by an actuatable element, wherein the adjustable swivel connector is configured to establish electrical communication between an implantable medical lead and a cable of an external testing device, wherein the adjustable slot is electrically conductive and configured to elastically deform to receive a lead connector of the implantable medical lead, wherein a proximal end of the slot is mechanically and electrically coupled to a pin of the adjustable swivel connector to provide electrical communication between the pin and the lead connector, and wherein the adjustable slot is configured to receive lead connectors of different sizes; mechanically disengaging the adjustable slot by the actuatable element to allow the adjustable slot to elastically deform to receive the lead connector of the implantable medical lead when transitioning from the second position relative to the adjustable slot to the first position relative to the adjustable slot; mechanically engaging the adjustable slot by the actuatable element to secure the lead connector of the implantable medical lead in the slot when transitioning from the second position relative to the adjustable slot to the first position relative to the adjustable slot; and The pin is rotated relative to the cable by a bearing of the adjustable swivel connector.

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