Systems, devices, and methods for rotatable electrical connection with a pacemaker

Abstract

Provided herein are systems, devices, and methods for providing a rotatable connection between a first medical device such as an implantable lead, and a second medical device, such as a diagnostic device configured to assess the location or other implantation characteristic of the implanted lead. An adapter can include a rotatable assembly that provides a rotatable electrical and / or other operable connection between the first and second medical devices.

Description

[0001] SYSTEMS, DEVICES, AND METHODS FOR ROTATABLE

[0002] ELECTRICAL CONNECTION WITH A PACEMAKER

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004]

[0001] This application claims priority to United States Provisional Patent Application Serial Number 63 / 602,315 (Client Docket No. CVT-001-PR1), titled “Electrical Connector For Pacemaker”, filed November 22, 2023 and United States Provisional Patent Application Serial Number 63 / 668,539 (Client Docket No. CVT-001-PR2), titled “Connector And Method For Rotatable Electrical Connection With A Pacemaker”, filed July 8, 2024, the content of each of which is incorporated by reference in its entirety.

[0005] FIELD OF THE INVENTIVE CONCEPTS

[0006]

[0002] The present inventive concepts relate generally to systems, devices, and methods in the field of cardiac electrophysiology.

[0007] BACKGROUND

[0008]

[0003] Conventional connectors for attaching pacemaker leads to testing or monitoring equipment are configured in such a way that positioning of one or more devices to a pacemaker becomes problematic, particularly when a surgeon or other healthcare worker is attempting to perform an implantation or diagnostic procedure with a pacemaker in a real time surgical environment. Positioning the pacemaker lead itself, during implantation, is often limited by patient positioning, which must remain substantially in a prone position. Positioning the pacemaker lead typically involves rotation, so that the lead can be tunneled into the heart tissue via rotation (e.g., with a screw at the tip of the lead). Rotating with conventional leads can lead to cable entanglement such that rotation cannot be beyond 180 degrees. Accordingly, there exists a need to provide an improved device which facilitates easy positioning of medical diagnostic or monitoring equipment relative to a pacemaker being implanted into a patient. SUMMARY

[0009]

[0004] According to one aspect of the present inventive concepts, an adapter (e.g., an electrical connector) for connecting a fist medical device (e.g., a pacemaker lead) to a peripheral medical device is provided. The adapter includes a body having a first end and a second end opposite the first end along a longitudinal axis, the body having a length along the longitudinal axis. The adapter further includes a first connector (e.g., a pacemaker lead port) at the first end, the first connector being configured to receive a mating connector (e.g., a plug) of the first medical device (e.g., a pacemaker lead) therein, the first connector being configured to permit rotation of the first connector relative to a second connector (e.g., a cable socket) at the second end of the adapter.

[0010]

[0005] According to another aspect of the present inventive concepts, there is provided a method of connecting a first medical device (e.g., a pacemaker lead) to a peripheral medical device. The method includes inserting a proximal end of the first medical device (e.g., the proximal end of a pacemaker lead) into a first end of an adapter (e.g., an electrical connector); and connecting a second end of the adapter to the peripheral medical device.

[0011]

[0006] According to another aspect of the present inventive concepts, a method of connecting a medical device lead to a second medical device comprises: inserting a proximal end of a lead comprising a medical device lead (e.g., a pacemaker lead) into a port of a first connector at a first end of an adapter; connecting a second connector at a second end of the adapter to the second medical device; and rotating the lead so that the first connector rotates relative to the second connector while maintaining at least electrical contact between the lead and the second medical device.

[0012]

[0007] In some embodiments, the rotation of the lead includes rotating a plurality of electrically conductive ribbons and / or brushes relative to a plurality of electrically conductive rings. The method can further comprise conducting an electrical current (e.g., cardiac signals, brain signals, and / or other physiologic signals of a patient) from the lead, through the adapter, and into the second medical device.

[0013]

[0008] In some embodiments, the step of connecting includes clipping the second connector of the adapter to a cable of the second medical device.

[0014]

[0009] In some embodiments, the second medical device includes an analyzer for pacemaker lead diagnostic evaluation.

[0010] According to another aspect of the present inventive concepts, an adapter for connecting a first medical device to a second medical device is provided. The adapter comprises: a body having a first end and a second end opposite the first end along a longitudinal axis, the body having a length along the longitudinal axis; a first connector at the first end, the first connector being configured to receive a mating connector of the first medical device therein, the first connector including a rotational assembly configured to permit rotation of the first connector relative to the second medical device; and a second connector at the second end.

[0015] [Oi l] In some embodiments, the body is flexible. The body can encase an electrical wire along its length. The electrical wire can be soldered to the second connector.

[0016]

[0012] In some embodiments, the second connector comprises a clip. The clip can be an alligator clip.

[0017]

[0013] In some embodiments, the rotational assembly comprises a plurality of electrically conductive ribbons and / or brushes. The ribbons and / or brushes can be flexible. The ribbons and / or brushes can project inwardly along a line parallel to the longitudinal axis of the body. The ribbons and / or brushes can project inwardly in an offset manner compared to the longitudinal axis of the body.

[0018]

[0014] In some embodiments, the rotational assembly includes at least four ribbons and / or brushes. In some embodiments, the rotational assembly contains no more than ten ribbons and / or brushes.

[0019]

[0015] In some embodiments, a first portion of the rotational assembly is configured to remain rotationally stationary about the longitudinal axis of the body while the mating connector of the first medical device rotates relative to the second connector.

[0020]

[0016] According to another aspect of the present inventive concepts, a medical system comprises: an adapter configured to operably attach to one or more devices; a first medical device comprising at least an implanted portion; and a second medical device configured to perform an analysis of the implanted portion of the first medical device. The adapter can be configured to rotatably and electrically connect the first medical device to the second medical device.

[0021]

[0017] In some embodiments, the adapter is further configured to provide a fluidic, sonic, optic, mechanical, and / or other non-electrical connection between the first medical device and the second medical device.

[0018] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0022] INCORPORATION BY REFERENCE

[0023]

[0019] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in Australia or in any other country.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0025]

[0020] Fig. 1 is a block diagram of a medical system including an adapter comprising a rotatable connector, consistent with the present inventive concepts.

[0026]

[0021] Fig. 1A is an upper perspective, leading end view of an adapter for operably connecting two medical devices, in accordance with an embodiment of the present disclosure.

[0022] Fig. IB is an upper perspective, trailing end view of the adapter of Fig. 1A.

[0027]

[0023] Fig. 2 is an exploded upper perspective view of the adapter of Fig. 1A.

[0028]

[0024] Fig. 3A is a side elevation view of the adapter of Fig. 1 A.

[0029]

[0025] Fig. 3B is a cross sectional side elevation view of the adapter of Fig. 3A.

[0030]

[0026] Fig. 3C is a partial expanded cross sectional side view of a lead port taken along line

[0031] B of Fig. 3B.

[0032]

[0027] Fig. 3D is a partial expanded cross sectional side view of a connector clip taken along line C of Fig. 3B.

[0033]

[0028] Fig. 3E is a partial cross sectional front view of the leading end of the adapter of Fig.

[0029] Fig. 4 is a side view of a patient shown connected to medical testing equipment with the adapter of Fig. 1.

[0034]

[0030] Fig. 5A is a perspective view of an adapter in accordance with another embodiment of the present inventive concepts, with the leading end of the adapter shown in partial cross section.

[0035]

[0031] Fig. 5B is a cross sectional side elevation view of the leading end of the adapter of Fig. 5A.

[0036]

[0032] Fig. 6A is a side view of the leading end of the adapter of Fig. 5A.

[0037]

[0033] Fig. 6B is a top plan elevation view of the leading end of the adapter of Fig. 6A.

[0038]

[0034] Fig. 6C is a partial cross sectional side elevation view of the leading end of the adapter of Fig. 6B.

[0039]

[0035] Fig. 6D is a perspective view of the leading end of the adapter of Fig. 6A.

[0040]

[0036] Fig. 7 is a partial, side-sectional view of an embodiment of the leading end of an adapter, consistent with the present inventive concepts.

[0041]

[0037] Fig. 8 is a partial, side-sectional view of the leading end of another embodiment of a leading end of an adapter, consistent with the present inventive concepts.

[0042]

[0038] Fig. 9 is a partial, side-sectional view of the leading end of another embodiment of a leading end of an adapter, consistent with the present inventive concepts.

[0043]

[0039] Fig. 10 is a partial, side-sectional view of the leading end of another embodiment of a leading end of an adapter, consistent with the present inventive concepts.

[0044] DETAILED DESCRIPTION OF THE DRAWINGS

[0045]

[0040] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0046]

[0041] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0047]

[0042] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0048]

[0043] It will be further understood that when an element (also referred to as a “component” herein) is described as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0049]

[0044] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0050]

[0045] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0051]

[0046] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g. a blood or other fluid delivery location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0047] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", “under” and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0052]

[0048] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0053]

[0049] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0054]

[0050] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0055]

[0051] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0056]

[0052] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have

[0057] A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A,

[0058] B, and C, the feature can have only one or two of A, B, or C.

[0059]

[0053] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0060]

[0054] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0061]

[0055] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[0062]

[0056] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g. above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g. below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient, user, and / or operator variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0063]

[0057] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0064]

[0058] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[0065]

[0059] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0066]

[0060] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and / or a transducer. In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g. a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g. a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g. a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g. to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g. to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0061] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g. a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g. variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0067]

[0062] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0063] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0068]

[0064] As used herein, the term “user interface” can comprise one or more interfaces, each interface comprising one or more components configured to receive an input from a user, “user input device” herein, and / or one or more components configured to provide output to a user, “user output device” herein.

[0069]

[0065] The terms “data” and “information” are used interchangeably herein.

[0070]

[0066] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0071]

[0067] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0072]

[0068] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0073]

[0069] Provided herein are electrical connectors and other adapters for connecting at least a first medical device to at least a second medical device. These adapters can comprise a rotatable assembly, such as a slip ring assembly, that allows rotations of these medical devices (e.g., cables of these medical devices relative to each other), while avoiding twisting, binding, or other undesired impacts on the associated components.

[0074]

[0070] Referring now to Fig. 1, a block diagram of an embodiment of a medical system including an adapter for electrically and / or otherwise operably attaching a first medical device to a second medical device is illustrated. System 10 can include one or more devices for providing a rotatable, operable connection between two or more devices, adapter 100. Adapter 100 can be constructed and arranged to permanently and / or temporarily attach one or more first medical devices (e.g., a device that is at least partially implanted) to one or more second medical devices (e.g., an analyzer or other piece of medical equipment), and to provide rotation (e.g., rotation between two or more connecting portions of adapter 100) to prevent twisting of any flexible components (e.g., cables) of the two connected medical devices. For example, adapter 100 can rotatably and operably attach one or more patient devices, patient device 500 (also referred to herein as PD 500), to one or more pieces of medical equipment, medical equipment 600 (also referred to herein as ME 600), each shown. Adapter 100 can be configured to provide a rotatable, electrical or otherwise operable connection (“rotatable connection” herein) between two or more attached devices, for example a connection that allows relative rotation between a portion of PD 500 and ME 600, for example without “wind-up” or other undesired state of adapter 100 caused by the rotation.

[0075]

[0071] In some embodiments, PD 500 can comprise one or more leads, such as lead 501. In some embodiments, PD 500 includes one or more functional assemblies, functional assembly 510, such as a functional assembly comprising one or more functional elements, for example one or more electrodes (e.g., one or more electrodes configured to deliver energy to tissue and / or to sense electrical signals). In some embodiments, PD 500 (e.g., PD 500 comprising lead 501) includes an elongate body, lead body 520, that extends from functional assembly 510 to a connector, connector 530, that is located on the opposite end of lead body 520 from functional assembly 510. Lead 501 can include one or more conductors, linkages, and / or other conduits, such as wire 525, that operably (e.g., at least electrically) connects functional assembly 510 to connector 530. In some embodiments, lead 501 is fixedly attached to functional assembly 510 (e.g., lead 501 comprises functional assembly 510). For example, lead 501 can include a pacemaker lead, where functional assembly 510 includes one or more electrodes that are implanted and / or otherwise electrically coupled to cardiac tissue, and where lead body 520 extends through the tissue of the patient to a location remote from the heart of the patient, and connector 530 is configured to operably attach to a controller portion of PD 500, such as controller 550 shown (e.g., a pacemaker “can”).

[0076]

[0072] In some embodiments, lead body 520 comprises wires 525. Adapter 100 can be configured to operably attach to connector 530 of PD 500 (e.g., prior to connector 530 being connected to controller 550, such as to test or otherwise evaluate a portion of functional assembly 510, such as to evaluate the viability of one or more implantation locations of functional assembly 510). In some embodiments, lead 501 is removably attached to functional assembly 510, for example, when lead 501 comprises a cable or other connecting device configured to operably attach two or more functional assemblies 510 and / or controllers 550 (e.g., lead 501 can be configured to attach a first functional assembly to a second functional assembly, which is attached to a controller, such as in a daisy-chain arrangement).

[0077]

[0073] PD 500 can comprise an implantable and / or non-implantable medical device, such as a device selected from the group consisting of: implantable or non-implantable medical device; pacemaker (e.g., at least a pacemaker lead); defibrillator (e.g., at least a defibrillator lead); stimulator such as a deep brain stimulator or pain-relieving stimulator (e.g., at least a stimulator lead); an implantable or non-implantable infusion pump (e.g., at least a catheter of an infusion pump); intracardiac electrophysiology diagnostic and / or ablation catheter; and combinations thereof. PD 500 can include a multi-part device, such as a device comprising a lead, such as lead 501, and a controller, such as controller 550. Lead 501 can be operably attachable to controller 550 (e.g., during a clinical procedure, such as an implantation procedure). In some embodiments, adapter 100 is temporarily attached to lead 501 and / or another portion of PD 500 during a clinical procedure, for example to operably attach lead 501 to ME 600 for testing (e.g., implantation viability testing) prior to operably attaching lead 501 to controller 550.

[0078]

[0074] In some embodiments, ME 600 includes one or more cables, such as cable 610 comprising connector 615. In some embodiments, ME 600 includes one or more consoles, console 650. Cable 610 can be fixedly and / or removably attached to console 650 and can extend from console 650 such that connector 615 can operably attach to another device or assembly of system 10, such as to connector 530 of patient device 500 and / or to a connector of adapter 100. In some embodiments, adapter 100 comprises an adapter that is configured to operably attach connector 615 to connector 530 of patient device 500. For example, adapter 100 can be configured as an adapter that allows rotation between connector 615 and connector 530.

[0079]

[0075] Adapter 100 can include one or more elongate cables, body 140 shown. Adapter 100 can include a first end portion, distal portion 101, and a second end portion, proximal portion 108, each shown. As used herein, distal shall describe a direction away from a clinician and / or ME 600 and toward the patient (e.g., closer to the medical equipment is more proximal, and closer to the patient is more distal). Adapter 100 can include a first connector assembly, patient device connector assembly 110 (also referred to herein as PDCA 110), that is located at distal portion 101 of adapter 100. Additionally, or alternatively, adapter 100 can include a second connector assembly, medical equipment connector assembly 150 (also referred to herein as MECA 150), that is located on proximal portion 108 of adapter 100. In some embodiments, adapter 100 is void of any cable or other flexible portion between distal portion 101 and proximal portion 108 (e.g., adapter 100 is a single, rigid, tubular component providing a rotatable connection between two cables or any two attached devices).

[0080]

[0076] Body 140 can include a shaft, shaft 141, that extends between PDCA 110 and MECA 150. Adapter 100 can include one or more functional linkages, such as wires 142 shown, that extend from PDCA 110 to MECA 150 through of shaft 141 (e.g., through one or more lumens of shaft 141 and / or otherwise within or along shaft 141). Wires 142 can comprise one, two, or more electrical conductors. Alternatively, or additionally, wires 142 can comprise one or more components selected from the group consisting of: optical fibers; fluid delivery tubes (e.g., hydraulic and / or pneumatic delivery tubes, and / or medication delivery tubes); waveguides; mechanical linkages; and combinations of one, two, or more of these.

[0081]

[0077] PDCA 110 can include a single and / or multi-channel contact assembly, contact 120, that operably attaches to one or more contacts of a mating connector for PDCA 110, such as one or more electrical pins of connector 530 of PD 500 (e.g., one or more contact pins of a pacemaker lead that are inserted into PDCA 110). Contact 120 can be operably attached to one or more wires 142, such as to functionally (e.g., electrically) connect PD 500 to wires 142 when connector 530 is operably attached to PDCA 110.

[0082]

[0078] In some embodiments, PDCA 110 includes a rotational assembly, such as rotation assembly 130 shown. Rotation assembly 130 can be configured to enable one or more electrical and / or other connections (e.g., electrical, optical, fluidic, mechanical, and / or other connections) to be maintained within PDCA 110 while enabling rotation (e.g., rotation about the longitudinal axis of body 140) between body 140 and PDCA 110. In some embodiments, rotation assembly 130 can include one or more housings (e.g., housing 131 described herein) that surrounds one or more functional mechanisms of rotation assembly 130, as described herein. In some embodiments, rotation assembly 130 comprises a “slip-ring” type assembly, for example a rotatable electrical connector assembly comprising one, two, or more conductive “rings” electrically and rotatably connected to a corresponding one, two, or more conductive “brushes”, for example SRA 135 described herein.

[0083]

[0079] In some embodiments, PDCA 110 comprises a rotatable connector that makes one or more rotatable non-electrical connections, such as a rotatable fluid connection (e.g., providing one, two, or more gas or liquid connections), a rotatable mechanical linkage connection, a rotatable optical connection (e.g., one, two, or more light or other optical connections), a rotatable sound connection (e.g., one, two, or more ultrasound and / or other sound connections), and / or other rotatable operable connections (e.g., as an alternative to or in addition to one or more rotatable electrical connections). In some embodiments, PDCA 110 comprises a rotatable connector that makes at least one electrical connection and at least one non-electrical connection.

[0080] In some embodiments, MECA 150 is configured to operably attach to ME 600 (e.g., to attach directly to console 650 via an electrical attachment port). Alternatively, or additionally, MECA 150 can be configured to operably attach to connector 615 of cable 610, as described herein. In some embodiments, MECA 150 is configured to provide a rotatable connection, for example in a similar manner to PDCA 110 described herein.

[0084]

[0081] In some embodiments, system 10 includes one or more medical tools, tool 80 shown, such as surgical tools, implant assist devices, or other implements that can be utilized by a clinician in a medical procedure, such as a medical procedure where a patient device (e.g., lead 501) is implanted into the patient. In some embodiments, tool 80 comprises a stylet, stylet 81 shown. In some embodiments, lead body 520 comprises one or more lumens extending at least partially therethrough, lumen 521. In some embodiments, lumen 521 is configured to slidingly receive stylet 81, for example, when stylet 81 is used during implantation of lead 501 (e.g., to provide stiffness, pushability, and / or to rotate a portion of lead 501). In some embodiments, stylet 81 is configured to be slidingly received within lumen 521, and to operably engage functional assembly 510, for example a functional assembly 510 comprising an array of one or more electrodes that are positioned on or proximate the distal end of lead body 520, where functional assembly 510 is configured to rotatably engage tissue (e.g., to “screw” into tissue). Lead body 520 (e.g., with or without an inserted stylet 81 and / or other tool 80) can be rotated (e.g., by the clinician) to engage a portion of functional assembly 510 with tissue (e.g., with cardiac tissue). As described herein, at least a portion of PDCA 110 can be configured to freely rotate in unison with lead body 520 (e.g., while connected to connector 530, at least a portion of PDCA 110 is rotationally fixed to at least a portion of lead 501) relative to body 140 of adapter 100.

[0085]

[0082] In some embodiments, system 10 (e.g., adapter 100, patient device 500, and / or medical equipment 600) includes one or more functional elements, functional element 99 shown. Functional element 99 can comprise one, two, or more sensors, and / or one, two, or more transducers. Functional element 99 can comprise a functional assembly, such as is described herein. In some embodiments, functional element 99 comprises a lubricant (e.g., an electrically conductive lubricant), and / or a functional assembly configured to deliver a lubricant to one or more rotating components of adapter 100. In some embodiments, functional element 99 comprises a radiation tracking element, such as a radiation tracking element configured to monitor the exposure of adapter 100 to X-rays or other radiation (e.g., where such radiation exposure can eventually compromise the functionality of adapter 100). In some embodiments functional element 99 comprises a securing assembly, such as an assembly comprising a clip or other securing element that can maintain the position of adapter 100 to a particular location (e.g., a bed, table, piece of patient clothing, and the like).

[0086]

[0083] Referring now to Figs. 1A through 3D, various perspective, exploded, sectional, and detail magnified views of embodiments of an adapter are illustrated, respectively, consistent with the present inventive concepts. Adapter 100 and / or other components of Figs. 1 A through 3D can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Figs. 1A and IB show opposite perspective views of adapter 100 including body 140. Adapter 100 includes distal portion 101 and proximal portion 108 opposite distal portion 101 along a longitudinal axis of body 140. Adapter 100 can include PDCA 110 (positioned on distal portion 101) that can be configured to receive a connector portion (e.g., a pin) of an implanted patient device, such as the proximal end of a pacemaker lead (e.g., a lead that is at least partially implanted in the patient). Adapter 100 can include MECA 150 (positioned on proximal portion 108) that can be configured to securely attach to ME 600 (not shown but described herein), such as to a cable 610 that is operably attached to console 650, such as a console 650 comprising a pacemaker lead analyzer or monitor. Various embodiments of adapter 100 including various elements of adapter 100 and their interrelationship are described herein.

[0087]

[0084] PDCA 110 can include a casing surrounding one or more components of the connector, housing 115. Housing 115 can include one or more internal recesses and / or openings into housing 115, such as one or more recesses or openings comprising a shape configured to operably engage with another component of system 10, as described herein. For example, housing 115 can comprise a cone shaped portion, nozzle 116, that tapers from a wider, flared portion, base 117. Housing 115 can include a first opening for receiving a portion of patient device 500, such as port 1161 shown. Additionally, or alternatively, housing 115 can include a second opening, such as port 1171, for example port 1171 into base 117, that is positioned opposite port 1161 (for example as shown in Figs. 3B and 3C and otherwise herein).

[0088]

[0085] Housing 115 can include a longitudinal passage, passage 1155, extending from port 1161 to port 1171. Passage 1155 can comprise a stepped profile (e.g., following the flared and tapered profile portions of nozzle 116 and base 117), that defines one or more internal chambers of different diameters, such as one or more chambers that surround components of PDCA 110 (e.g., components integrated with housing 115 in a manufacturing process) and / or one or more chambers configured to slidingly or otherwise receive a portion of a device during use, such as to slidingly receive a mating portion of connector 530 of patient device 500, as described herein. For example, housing 115 can include a first chamber, distal chamber 1151, a second chamber, middle chamber 1152, and / or a third chamber, proximal chamber 1153. In some embodiments, distal chamber 1151 and middle chamber 1152 can be located primarily within nozzle 116 of housing 115, and proximal chamber 1153 can be located primarily within base 117 of housing 115, for example as shown in Fig. 3C.

[0086] In some embodiments, housing 131 of rotation assembly 130 is located within proximal chamber 1153 of housing 115. In some embodiments, the shape of base 117 and proximal chamber 1153 are configured to receive housing 131 of rotation assembly 130. The proximal end of chamber 1153 can comprise a tapered or other inward surface configured to limit the insertion depth of housing 131 into housing 115 (e.g. due to the tapered profile of nozzle 116 and flared profile of base 117, as described herein).

[0089]

[0087] Contact 120 can include a receiving portion, port 121, that slidingly or otherwise receives a portion of connector 530, and an attachment portion, base 122, that operably attaches to one or more wires 142. Port 121 can include one or more electrical contacting portions, pickups 1211, and base 122 can include one or more electrical contacts, pads 1221. In some embodiments, for example when contact 120 comprises a multi-channel contact, each pickup 1211 can be electrically connected to a pad 1221, and electrically isolated from other pickups 1211 (e.g., when contact 120 comprises a dielectric body with one or more traces or wires connecting pairs of pickups 1211 and pads 1221). In some embodiments, PDCA 110 includes one or more electrical and / or other functional conduits, wires 123. In some embodiments, wires 123 operably connect contact 120 to rotational assembly 130, as described herein.

[0090]

[0088] In some embodiments, rotational assembly 130 can include one or more housings, housing 131, surrounding functional mechanisms of the assembly. In some embodiments, rotational assembly 130 can comprise a slip ring assembly, SRA 135. At least a portion of SRA 135 can be positioned within housing 131. SRA 135 can include a fixed portion (e.g., a portion of the assembly rotationally fixed to housing 131), stator 136, and a rotatable portion, core 137. Core 137 can be configured to rotate within housing 131 (e.g., relative to stator 136), while one or more electrical connections are maintained between core 137 and stator 136. Stator 136 can include one or more conductive ribbons and / or brushes, brushes 1361. Core 137 can include one or more circumferential conductive surfaces, rings 1371. Each brush 1361 can include one or more conductive surfaces, pads 1362 that are configured to electrically engage rings 1371 (e.g., by contacting or brushing against the conductive surface of an associated ring 1371). In some embodiments, rotational assembly 130 includes one or more rotational bearings, bushing 139. Bushing 139 can be configured to reduce friction between two or more rotating portions of rotational assembly 130 and / or PDCA 110.

[0089] In some embodiments, shaft 141 includes one or more lumens therethrough, such as lumen 1411 shown. Wires 142 can extend from PDCA 110 to MECA 150 through lumen 1411.

[0090] Fig. 2 shows an exploded view of an embodiment of adapter 100. Shaft 141 of body 140 can be formed as an elongated, tubular structure including lumen 1411 extending therethrough. One or more conduits or linkages, such as wires 142 can extend through lumen 1141, as described herein. Shaft 141 can be constructed from a durable, medical-grade material, such as polyolefin, polyether block amide (pebax), and / or other polymer materials. In some embodiments, shaft 141 can be flexible ( e.g. , comprise one, two, or more flexible portions), such as to enable easier multi-directional positioning. In some embodiments, lumen 1411 comprises multiple lumens, for example multiple lumens each configured to receive one or more wires 142, for example, such that wires 142 within separate lumens 1411 remain electrically or otherwise isolated (e.g., isolated by dielectric material of shaft 141). In some embodiments, lumen 1411 is configured to receive a fiberoptic linkage, such as when wire 142 comprises one or more fiberoptic cables.

[0091]

[0091] Figs. 3A through 3E show a side view of adapter 100, a side sectional view of adapter 100, a magnified detail view of distal portion 101, a magnified detail view of proximal portion 108, and an end view of adapter 100, respectively. Adapter 100 can include PDCA 110 located at distal portion 101. PDCA 110 can be configured to connect with an electrical connector, such as connector 530 of patient device 500 (e.g., a lead pin of a pacemaker lead or other implantable medical device lead), not shown but described herein.. As shown in Figs. 2 and 3C, housing 115 of PDCA 110 can include nozzle 116 with port 1161, and base 117 with port 1171 opposite port 1161 along a central longitudinal axis of housing 115. As described herein, housing 115 can include passage 1155 from port 1161 to port 1171. Passage 1155 can comprise a multi-stepped profile creating three chambers of different diameters, distal chamber 1151, middle chamber 1152, and proximal chamber 1153, each shown. Distal chamber 1151 can be configured to receive connector 530 (e.g., the pin of the implanted lead). Middle chamber 1152 can be sized and configured to receive contact 120. In some embodiments, one or more wires, such as wires 123, can be soldered to pads 1221 of contact 120 (e.g., four wires 123). Wires 123 can operably connect one or more pads 1221 of contact 120 to brushes 1361 of SRA 135. Proximal chamber 1153 can be sized and configured to receive housing 131 of rotation assembly 130. Proximal chamber 1153 can comprise the largest diameter of the three internal chambers within housing 115. The stepped profile of passage 1155 can function as a depth stop for housing 131 when inserted into housing 115 (e.g., in a manufacturing process).

[0092]

[0092] Fig. 3B shows MECA 150 attached to the clinician end (e.g., the proximal end) of body 140. In some embodiments, MECA 150 comprises an “alligator clip” type connector, such as clip 151 shown. For example, clip 151 can include an upper moveable jaw, jaw 1511. Clip 151 can further include a finger engagement surface, surface 1512, and a lower jaw, jaw 1513. Jaws 1511 and 1513 can each include a cable engagement surface, surface 1514 and surface 1515, respectively, which may be formed to include a plurality of retention teeth. Jaws 1511 and 1513 of clip 151 can be biased to close toward one another with a biasing means, such as a coil or spring, spring 1516. The exterior surface of jaw 1511 can be angled so that the leading ends of jaws 1511 and 1513 converge to a smaller cross sectional area, such as to facilitate improved directional engagement. MECA 150 can comprise an alligator clip and / or other universal connecting component that can be configured to attach (e.g., simultaneously or sequentially) to multiple different types of medical equipment 600.

[0093]

[0093] Figs. 2 and 3B show body 140 extending from PDCA 110. Body 140 (and wires 142 therein) can be fixedly attached to a portion of rotation assembly 130 that is configured to rotate relative to housing 131, such that body 140 can rotate relative to PDCA 110 (e.g., rotate at least 90°, or at least 180°, without applying a force of more than ImNm to patient device 500). Rotation assembly 130 can be configured to support an infinite number of rotations, and to prevent any sufficient torque being applied to lead 501 and / or another portion of patient device 500. Housing 131 can be insertable (e.g., in a manufacturing process) into proximal chamber 1153 of housing 115, as described herein. In some embodiments, the outer diameter of housing 131 is configured to approximate the inner diameter of proximal chamber 1153. Rotational assembly 130 can be constructed and arranged to provide a rotatable electrical connection between contact 120 (e.g., when contact 120 is rotationally fixed to housing 115) and body 140 (e.g., wires 142 that are rotationally fixed within shaft 141 of body 140), such that contact 120 and / or housing 115 can rotate relative to body 140 while maintaining an operable connection with an attached PD 500 (e.g., an attached lead 501). In some embodiments, wires 142 are operably attached to MECA 150, for example when wires 142 are soldered or otherwise electrically coupled to a portion of MECA 150 (e.g., to jaw 1513).

[0094] Referring additionally to Fig. 4, a system view including a representation of a patient is illustrated, consistent with the present inventive concepts. Adapter 100 and / or other components of system 10 described in Fig. 4 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In the embodiment shown, patient device 500 comprises lead 501, as described herein. Adapter 100 can operably connect (e.g., at least electrically connect) to lead 501 via connector 530. Adapter 100 can operably connect to ME 600 via connector 615 of cable 610 (e.g., which is operably connected to console 650). Alternatively, adapter 100 can attach directly to console 650, such as to an attachment port (e.g., an electrical attachment port) of console 650. In some embodiments, adapter 100 is configured to attach directly to a non-lead portion of PD 500, such as directly to an attachment port (e.g., an electrical attachment port) of a functional assembly 510 and / or a controller 550 of PD 500. In some embodiments, adapter 100 is configured to connect to two components of PD 500, such as to provide a temporary connection between the two portions. For example, adapter 100 can operably connect to connector 530 of lead 501 (e.g., following implantation of functional assembly 510 of lead 501), and to controller 550 via an electrical attachment port (e.g., prior to implantation of controller 550 and / or direct connection of lead 501 to controller 550).

[0094]

[0095] An example usage of adapter 100 can comprise operably attaching a pacemaker or other medical device lead (e.g., lead 501, such as when at least a portion of lead 501 is implanted in the patient) to diagnostic and / or monitoring equipment (e.g., ME 600). For example, prior to implantation of lead 501 into the patient, a user (e.g., a healthcare professional) can insert a pinlike connector (e.g., connector 530) positioned at the proximal end of lead 501 (e.g., opposite functional assembly 510) into port 1161 of nozzle 116 of PDCA 110. The user can also attach MECA 150 to the medical diagnostic or monitoring equipment, for example MECA 150 comprising clip 151. The user can press surface 1512 of j aw 1511 towards j aw 1513 to open clip 151. Clip 151 can then be positioned over connector 615 of cable 610 that is operably attached to console 650 of ME 600, then jaws 1151 and 1153 can be released to securely “clip” MECA 150 to cable 610. Functional assembly 510 of lead 501 can then be implanted into the patient. In some embodiments, a connecting portion of patient device 500 (e.g., lead 501) is rotated into position in the patient, for example, a rotation of 15 to 20 full revolutions. Adapter 100 can be configured to accommodate rapid rotation of the connecting portion of patient device 500 (e.g., rapid rotation of lead 501), such as rotations of at least 5, 10, and / or 20 revolutions per second. PDCA 110 can remain in a relatively stationary position (e.g., be held in position by the user and / or remain unmoved due to lack of external forces) while lead 501 is rotated during the implant procedure. In some embodiments, low-friction rotation of housing 115 relative to body 140 (e.g., rotation enabled by rotation assembly 130), prevents rotation and / or binding of body 140, and prevents unwanted motion of PDCA 110. Lead 501 can then be electrically connected to console 650 of ME 600 by connecting cable 610 to console 650 with a minimal amount of positioning or other manipulation of lead 501 (e.g., adapter 100 and / or cable 610 can be routed by the user to connect lead 501 to console 650 without applying unnecessary force or unnecessarily moving any portion of lead 501). It will be appreciated that the steps described above may be performed in a different order, varied, or some steps omitted entirely without departing from the scope of the present disclosure. For example, clip 151 may be engaged with connector 615 of cable 610 prior to engagement of PDCA 110 with connector 530 of lead 501.

[0096] Referring now to Figs. 5 through 6D, various images of an embodiment of an adapter including a patient device connector assembly including an axial passage, and detailed images of the connector assembly are illustrated, respectively, consistent with the present inventive concepts. Adapter 100 and / or other components of system 10 described in Figs. 5 through 6D can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Adapter 100 can comprise an embodiment of a patient device connector assembly, PDCA 110’. PDCA 110’ can include an axial passage, passage 118 shown. Passage 118 can extend along a longitudinal axis (e.g., a central longitudinal axis) of PDCA 110’. Passage 118 can be configured to slidingly receive at least a portion of patient device 500 and / or tool 80 (e.g., stylet 81). PDCA 110’ can include an embodiment of a rotational assembly, rotational assembly 130’. Rotational assembly 130’ can include a passage, passage 138, that axially aligns with passage 118 of PDCA 110’. Referring to Figs. 5A and 5B, adapter 100 can include PDCA 110’ at distal portion 101 of body 140, and MECA 150 at proximal portion 108 (e.g., opposite distal portion 101). PDCA 110’ can include passage 118 extending through housing 115, including base 117 and nozzle 116. In some embodiments, base 117 of PDCA 110’ is larger than base 117 of PDCA 110, for example to accommodate a larger rotation assembly 130’ (e.g., larger than rotation assembly 130 without passage 138). Passage 118 can be configured to slidingly receive one or more elongate devices, such as a portion of lead body 520 of lead 501, and / or a medical tool or instrument, such as stylet 81, as shown in Fig. 5A. Rotational assembly 130’ can be located within base 117 of housing 115 of PDCA 110’. Rotational assembly 130’ can comprise slip ring assembly 135. As described herein, slip ring assembly 135 can include a plurality of brushes 1361. Each brush 1361 can include pad 1362 that is configured to electrically engage a portion of core 137 by contacting or brushing against an exterior surface of an associated ring 1371. Core 137 can include a plurality of rings 1371. Each ring 1371 can be separated by a material that electrically isolates one ring 1371 from another, and from other portions of core 137 and / or other portions of SRA 135. In some embodiments, passage 138 extends longitudinally through core 137, for example such that core 137 can rotate about a device that is slidingly received within passage 138.

[0095]

[0097] As shown in Fig. 5 A, core 137 can include passage 138 that can be configured to permit passage of (e.g., to slidingly receive) at least a portion of patient device 500 (e.g., at least a portion of lead body 520), and / or at least a portion of stylet 81. Figs. 6A through 6C illustrate exemplary dimensions of PDCA 110’. Dimensions shown in Figs. 6A through 6C should not be considered limiting to the scope of the present inventive concepts.

[0096]

[0098] In some embodiments, PDCA 110’ is used to operably attach PD 500 to ME 600, for example as shown and described in reference to Fig. 4. A portion of lead 501 can be implanted into the patient, for example lead 501 comprising a pacemaker lead. Before, during, and / or after at least a portion (e.g., at least functional assembly 510, not shown) of lead 501 is implanted, PDCA 110’ of adapter 100 can be attached to lead 501, such as via connector 530. MECA 150 of adapter 100 can be operably attached to connector 615 of cable 610 (e.g., that is attached to console 650 of ME 600). As shown in Fig. 5A, PDCA 110’ can slidingly receive stylet 81 through passage 118. In some embodiments, lead 501 comprises lumen 521 extending through lead body 520 (e.g., as shown in Fig. 1). Lumen 521 can be configured to slidingly receive at least a portion or stylet 81, for example such that PDCA 110’ can operably attach to connector 530 of lead 501 with stylet 81 slidingly received within passage 118. Adapter 100 can be attached to ME 600 via MECA 150. In some embodiments, adapter 100 can be manipulated and / or otherwise maneuvered into a desired position by a medical practitioner (e.g., while attached to lead 501 and / or ME 600), such as a maneuvering of adapter 100 that includes rotational movement. In some embodiments, rotational maneuvering of adapter 100 includes rotation of at least a portion of PDCA 110 relative to body 140 (e.g., when at least a portion of lead 501 is rotated while attached to a rotating portion of PDCA 110). One or more operable connections (e.g., electrical connections) can be maintained during rotational movement of PDCA 110, for example via engagement of bushes 1361 against rings 1371 of core 137. In some embodiments, core 137 is fixedly attached to body 140 of adaptive connector 100, for example when one or more portions of PDCA 100 are configured to rotate relative to core 137, such that body 140 does not twist or rotationally bind.

[0097]

[0099] Figs. 6A through 6D show engineering drawings of an example embodiment of PDCA 110’. Dimensions shown are approximate and should not be considered limiting to the scope of the present inventive concepts.

[0098]

[0100] Referring now to Fig. 7, a partial side-sectional view of an embodiment of a patient device connector assembly is illustrated, consistent with the present inventive concepts. Patient device connector assembly 110 and / or other components of Fig. 7 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 7 shows a side-sectional view of an embodiment of PDCA 110 with a portion of rotational assembly 130 shown in perspective relative to the cross section. Rotational assembly 130 can be located within housing 115, as shown and described herein. Housing 131 can be fixedly positioned within base 117 of housing 115. Rotation assembly 130 can comprise SRA 135, including stator 136 that is rotationally fixed to housing 131 and housing 115, and core 137 that is configured to rotate within stator 136. In some embodiments, rotational assembly 130 includes one or more bushings 139. Core 137 can include one or more surfaces configured to slidingly or otherwise engage bushings 139, such as bearing surface 1372 shown.

[0099]

[0101] Body 140 of adapter 100 can be fixedly attached to core 137, for example such that body 140 and core 137 are rotationally fixed relative to each other, and housing 115 of PDCA

[0100] 110 can rotate relative to body 140. Core 137 can include one or more rings 1371, such as one or more conductive rings that are each attached to one or more wires 142, as shown. SRA 135 can include one or more brushes 1361 including pads 1362 configured to provide a rotatable electrical connection between wires 142 attached to rings 1371 and wires 123 attached to brushes 1361.

[0101]

[0102] Wires 123 can be operably attached to pads 1221 of contact 120. Contact 120, including base 122 and port 121, can be positioned within nozzle 116 of housing 115, as shown. Port 121 can include one or more pickups 1211 that are configured to operably connect to corresponding electrical contacts of a connector 530 (not shown) that is configured to be inserted through port 1161 to operably attach to contact 120. In some embodiments, port 1161 comprises diameter D 1. Diameter D 1 can comprise a diameter selected to provide a frictional engagement with connector 530, such that rotation of housing 115 causes rotation of lead 501. Diameter D 1 can comprise a diameter of at least 1.5mm, 2.0mm, and / or 2.66mm and / or a diameter of no more than 5mm, 4mm, and / or 3.2mm.

[0102]

[0103] In some embodiments, the configuration and relative orientation of rings 1371 and brushes 1361 is reversed from the embodiment shown in Fig. 7, for example where stator 136 comprises rings 1371, and core 137 comprises brushes 1361 (e.g., such that pads 1362 rotate within and contact an inner surface of rings 1371). In this configuration, rings 1371 can be operably attached to pickups 1211 (e.g., via wires 123 and pads 1221). Brushes 1361 can be operably attached to wires 142.

[0103]

[0104] Referring additionally to Fig. 8, a partial side-sectional view of another embodiment of a patient device connector assembly is illustrated, consistent with the present inventive concepts. Patient device connector assembly 110’ and / or other components of Fig. 8 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 8 shows PDCA 110’, including rotational assembly 130’ with passage 138 therethrough. PDCA 110’ can include passage 118, that axially aligns with passage 138 such that an elongate device (e.g., stylet 81) can be slidingly received through PDCA 110’, as described herein. Body 140 can fixedly attach to core 137 in an off-center location, as shown, such as to allow passage 138 to extend through the center of core 137.

[0104]

[0105] In some embodiments, the configuration and relative orientation of rings 1371 and brushes 1361 is reversed from the embodiment shown in Fig. 8, for example where stator 136 comprises rings 1371, and core 137 comprises brushes 1361 (e.g., such that pads 1362 rotate within and contact an inner surface of rings 1371). In this configuration, rings 1371 can be operably attached to pickups 1211 (e.g., via wires 123 and pads 1221). Brushes 1361 can be operably attached to wires 142.

[0105]

[0106] Referring additionally to Fig. 9, a partial side-sectional view of another embodiment of a patient device connector assembly is illustrated, consistent with the present inventive concepts. Patient device connector assembly 110 and / or other components of Fig. 9 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Rotational assembly 130 can include an assembly for monitoring the rotational position of core 137 relative to stator 136 and / or counting relative rotations, such as rotational encoder assembly 133. In some embodiments, rotational encoder assembly 133 can include one or more sensors and / or one or more positional elements, such as sensor 1332 and magnet 1331, respectively. In some embodiments, sensor 1332 comprises a Hall effect sensor, such as a sensor configured to produce a signal when core 137 rotates such that sensor 1332 passes magnet 1331.

[0106]

[0107] Referring additionally to Figs. 10 through 11B, a partial side-sectional view of another embodiment of a patient device connector assembly, and four sectional views of torque measurement assemblies are illustrated, consistent with the present inventive concepts. Patient device connector assembly 110 and / or other components of Figs. 10 through 1 IB can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. PDCA 110 can include an assembly for measuring torque applied to body 140 by PDCA 110, such as torque measurement assembly 132. Figs. 10A and 10B show sectional views of an embodiment of torque measurement assembly 132 including two portions configured to rotate relative to each other, outer rotational element 1321 and inner rotational element 1322. Torque measurement assembly 132 can include one or more biasing elements, such as biasing elements 1326 shown. Biasing elements 1326 can be configured to resist rotation of inner rotational element 1322 relative to outer rotational element 1321. Torque measurement assembly 132 can include one or more sensors and / or one or more positional elements, such as sensor 1324 and magnet 1325, respectively. In some embodiments, sensor 1324 comprises a Hall effect sensor, such as a sensor configured to produce a signal related to the position of magnet 1325 relative to sensor 1324. In some embodiments, torque applied to torque measurement assembly 132 (e.g., torque between outer rotational element 1321 and inner rotational element 1322) can be measured based on the position of magnet 1325 relative to sensor 1324 and the spring force of biasing element 1326. Fig. 10B shows inner rotational element 1322 rotating relative to outer rotational element 1321.

[0107]

[0108] Figs. 11A and 1 IB show sectional views of an embodiment of a torque measurement assembly 132 including strain gauges, strain gauges 1327 shown. In some embodiments, strain gauges 1327 are fixedly attached between outer rotational element 1321 and inner rotational element 1322. Relative rotation between outer rotational element 1321 and inner rotational element 1322 can cause flexion of stain gauges 1327, as shown in Fig. 11B. Flexion of strain gauges 1327 can produce a signal related to the torque between outer rotational element 1321 and inner rotational element 1322.

[0108]

[0109] In some embodiments, inner rotational element 1322 can be fixedly attached to core 137 and outer rotational element 1321 can be fixedly attached to body 140 (or vice versa) such that torque measurement assembly 132 can measure torque between core 137 and body 140, as described herein.

[0109]

[0110] The foregoing description is by way of example only, and may be varied considerably without departing from the scope of the present disclosure. For example only, other cable engagement means aside from a clip (e.g., clip 151) may be utilized, such as a friction fit pin engagement similar to PDCA 110. Alternatively, the cable engagement could be via an insertion with a radially locking engagement to secure the connector end to the cable, or a pin insertion with a springlock engagement. Other connection forms may be utilized as appropriate for a given use or situation.

[0110]

[0111] The present disclosure in some embodiments provides the advantages of enabling continuous rotation of a medical device lead (e.g., pacemaker leads) during deployment into a location within a patient (e.g., into the myocardium) while maintaining electrical communication with a second medical device (e.g., a PSA / Analyzer device). In some embodiments, the connector overcomes limitations of existing configurations for solid core and stylet-driven pacemaker leads. The connector described herein also significantly enhances accuracy and assessment of lead position, such as during cardiac conduction pacing implant procedures, stimulator lead implant procedures, and deep brain lead implant procedures, which can be important for helping ensure a successful surgical outcome.

[0111]

[0112] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which are defined in the accompanying claims.

Claims

WHAT IS CLAIMED IS:

1. A method of connecting a medical device lead to a second medical device, comprising: inserting a proximal end of a lead comprising a pacemaker lead and / or other medical device lead into a port of a first connector at a first end of an adapter; connecting a second connector at a second end of the adapter to the second medical device; and rotating the lead so that the first connector rotates relative to the second connector while maintaining at least electrical contact between the lead and the second medical device.

2. The method of claim 1 , wherein the rotation of the lead includes rotating a plurality of electrically conductive ribbons and / or brushes relative to a plurality of electrically conductive rings.

3. The method of either claim 1 or 2, further comprising conducting an electrical current from the lead, through the adapter, and into the second medical device.

4. The method of any one of the above claims, wherein the step of connecting includes clipping the second connector of the adapter to a cable of the second medical device.

5. The method of any one of the above claims, wherein the second medical device includes an analyzer for pacemaker lead diagnostic evaluation.

6. An adapter for connecting a first medical device to a second medical device, comprising: a body having a first end and a second end opposite the first end along a longitudinal axis, the body having a length along the longitudinal axis; a first connector at the first end, the first connector being configured to receive a mating connector of the first medical device therein, the first connectorincluding a rotational assembly configured to permit rotation of the first connector relative to the second medical device; and a second connector at the second end.

7. The adapter of claim 6, wherein the body is flexible8. The adapter of either claim 6 or 7, wherein the body encases an electrical wire along its length.

9. The adapter of claim 8, wherein the electrical wire is soldered to the second connector.

10. The adapter of any one of claims 6 to 9, wherein the second connector comprises a clip.

11. The adapter of claim 10, wherein the clip is an alligator clip.

12. The adapter of any one of claims 6 to 11, wherein the rotational assembly comprises a plurality of electrically conductive ribbons and / or brushes.

13. The adapter of claim 12, wherein the ribbons and / or brushes are flexible.

14. The adapter of either claim 12 or 13, wherein the ribbons and / or brushes project inwardly along a line parallel to the longitudinal axis of the body.

15. The adapter of either claim 12 or 13, wherein the ribbons and / or brushes project inwardly in an offset manner compared to the longitudinal axis of the body.

16. The adapter of any one of claims 12 to 15, wherein the rotational assembly includes at least four ribbons and / or brushes.

17. The adapter of any one of claims 12 to 16, wherein the rotational assembly contains no more than ten ribbons and / or brushes.

18. The adapter of any one of claims 6 to 17, wherein a first portion of the rotational assembly is configured to remain rotationally stationary about the longitudinal axis of the body while the mating connector of the first medical device rotates relative to the second connector.

19. A medical system comprising:an adapter configured to operably attach to one or more devices; a first medical device comprising at least an implanted portion; and a second medical device configured to perform an analysis of the implanted portion of the first medical device; wherein the adapter is configured to rotatably and electrically connect the first medical device to the second medical device.

20. The system according to claim 19, wherein the adapter is further configured to provide a fluidic, sonic, optic, mechanical, and / or other non-electrical connection between the first medical device and the second medical device.

21. The system according to claim 19 or 20, wherein the adapter comprises an adapter of any one or more of claims 6 through 18.

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