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WO2025085811A1 - Fil-guide - Google Patents

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Publication number
WO2025085811A1
WO2025085811A1 PCT/US2024/052064 US2024052064W WO2025085811A1 WO 2025085811 A1 WO2025085811 A1 WO 2025085811A1 US 2024052064 W US2024052064 W US 2024052064W WO 2025085811 A1 WO2025085811 A1 WO 2025085811A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
segment
filar
mandrel
electrodes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/052064
Other languages
English (en)
Inventor
Robert S. Schwartz
Jonathan G. Schwartz
Ronald Von Wald
Daniel HAPPE
Jeffrey A. PUMPER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Draht Medical Inc
Original Assignee
Draht Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Draht Medical Inc filed Critical Draht Medical Inc
Publication of WO2025085811A1 publication Critical patent/WO2025085811A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/0915—Guide wires having features for changing the stiffness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip

Definitions

  • a transcatheter aortic valve replacement (“TAVR”) is a minimally invasive treatment for aortic valve stenosis, which is a narrowing of the aortic valve caused by the valve leaflets being thickened, calcified, or fused. These diseased leaflets cannot move correctly, resulting in restricted blood flow through the valve and causing a substantial pressure gradient between the left ventricle and the aorta. This condition can damage and weaken the heart muscle or other bodily tissue and functions over time.
  • the TAVR procedure has become the Standard of Care for minimally invasive percutaneous aortic valve replacement, having rapidly displaced the need for open chest surgical aortic valve replacement (SAVR) in a large majority of patients.
  • a guidewire includes a proximal end and a distal end.
  • the distal end includes a spiral segment and a distal tip.
  • a filar element is wound around a central axis that extends from the proximal end to the distal end to form a filar winding.
  • a mandrel is located within a lumen defined by the filar element.
  • Characteristics of one B&A Docket No.4146.002PCT1 or both of the filar winding and the mandrel are varied along an axial length to modify flexibility/rigidity characteristics of the guidewire along an axial length.
  • the techniques described herein relate to a medical system, including a guidewire.
  • the guidewire includes an elongate body having a mandrel and a filar element wound around the mandrel.
  • the elongate body is compliant to conform with surrounding tissue.
  • a distal end includes a plurality of electrodes.
  • the medical system includes a ground spike having a body having an exposed connection pad and a channel extending therethrough.
  • a pulse generator is electrically coupled to the plurality of electrodes.
  • the pulse generator is configured to provide a pacing current to the plurality of electrodes.
  • the guidewire extends through the channel of the ground spike.
  • the techniques described herein relate to a method of pacing cardiac rhythm with a guidewire.
  • the method incldues sensing electrophysiology (EP) signals with a plurality of electrodes disposed on the guidewire.
  • the guidewire includes an elongate body including a mandrel and a filar element wound around the mandrel.
  • the elongate body is compliant to conform with surrounding tissue.
  • a distal end includes the plurality of electrodes. Contact status of the plurality of electrodes is determined based on the sensed EP signals.
  • FIG.1 is a diagrammatic view of a medical system utilizing a sensor-enabled guidewire according to some embodiments.
  • FIG.2 is a diagrammatic view of a sensor-enabled guidewire having a plurality of portions with varying levels of flexibility positioned within the heart according to some embodiments.
  • FIG.3 is a cross-sectional view of the heart with a sensor-enabled guidewire having a distal end positioned against a ventricular wall according to some embodiments.
  • FIG.4 is a side view of the sensor-enabled guidewire having a first insulated conductive element and a second non-insulated conductive element wound at various pitches according to some embodiments.
  • FIG.5 is a side view of a mandrel according to some embodiments.
  • FIG.6 is a side view of a distal end of the sensor-enabled guidewire having a plurality of sensors positioned at various positions along the length of the guidewire according to some embodiments.
  • FIG.7 is a schematic view of a distal end of the sensor-enabled guidewire, according to some embodiments.
  • FIG.8 is a side view of the sensor-enabled guidewire having a distal end with an elliptical geometry according to some embodiments.
  • FIG.9 is an isometric view of a guide wire connector, according to some embodiments.
  • FIG.10 is an isometric view of a ground spike, according to some embodiments.
  • FIG.11 is a flow chart for a method of pacing cardiac rhythm with a guidewire, according to some embodiments.
  • DETAILED DESCRIPTION [0018] The present disclosure describes devices, systems, and/or methods for a guidewire placement within a body.
  • the guidewire is characterized by flexibility characteristics that allow the guidewire to conform to the geometry of the patient while providing sufficient rigidity to support the placement of catheter structures such as valve replacement structures.
  • the guidewire is comprised of a mandrel and a coil structure surrounding the mandrel.
  • the flexibility/rigidity of the guidewire is selectively modified via modifications to one or both of the mandrel and coil structure.
  • the flexibility/rigidity may be modified by modifying the pitch of the coils surrounding the mandrel.
  • the flexibility/rigidity may be modified by modifying the diameter of the mandrel.
  • the guidewire includes a flexible distal shaft to provide anchoring of the guidewire, thereby facilitating optimal electrical contact between the guidewire electrodes and the cardiac tissue.
  • the anchoring (or retention force) between the guidewire and the cardiac tissue can be increased by modifying the geometry of the distal end (e.g., a double spiral having primary and secondary curvature and/or via an oblong curvature to conform to an interventricular surface without introducing perforation risk.
  • the anchoring between the guidewire and the cardiac tissue can be utilized to deliver a secondary medical device (e.g., a stent, valve, balloon, etc.) to a treatment area.
  • the guidewire may also include one or more electrodes utilized for sensing and/or pacing of the heart.
  • one or more electrodes are positioned axially along the portion of the guidewire configured to be positioned within the heart muscle (for example, from the ascending aorta).
  • the electrodes may be positioned around an outer circumference of the coils such that the electrodes are positioned to contact adjacent tissue.
  • portions of insulation surrounding the coils may be ablated/removed to expose the underlying conductor to adjacent tissue, allowing the conductor associated with the coils to be utilized as an electrode.
  • portions of the mandrel i.e., distal tip
  • portions of the mandrel i.e., distal tip
  • a benefit of including one or more electrodes along an axial length of the guidewire is that the sensor information may be utilized to provide feedback regarding a procedure and to deliver therapies.
  • electrocardiogram (EKG) signals may be sensed by the electrodes (in combination with sensing circuitry) and utilized to detect when various portions of the guidewire have entered the heart muscle.
  • the sensed signals can be utilized to detect faults resulting from the guidewire puncturing and B&A Docket No.4146.002PCT1 exiting the heart.
  • sensed signals can be utilized to detect which of the plurality of electrodes are in contact with adjacent tissue within the heart and can be utilized to select electrodes for delivering pacing signals.
  • FIG.1 is a diagrammatic view of a medical system 100 including a guidewire 102 according to some embodiments.
  • the guidewire 102 includes a proximal end 104 and a distal end 106 configured for placement within the body of the patient.
  • the proximal end 104 of the guidewire 102 terminates at a guidewire connector 126 located external of the patient.
  • the guidewire 102 is configured to have various levels of stiffness at various axial positions along the length of the guidewire 102 from the proximal end 104 to the distal end 106.
  • the various levels of stiffness located at various axial positions allows the guidewire to provide flexibility at portions that need to conform to curves along the guide path (e.g., along the aorta arch, within the left ventricle) and provide stiffness at portions that do not require conforming to bends or curves.
  • the guidewire 102 does not include pre-formed or predetermined curved sections to accommodate these curves located along the guide path. Rather, the guidewire 102 is generally straight. In other words, the body of the guidewire 102 between the proximal end 104 and the distal end 106 is straight when in a resting state (i.e., in the absence of external forces such as gravity or contact with tissue).
  • the straightness of the guidewire 102 in-absence of external forces is beneficial, as the body of the guidewire 102 is not pre-formed or pre-shaped to fit a patient’s anatomy, according to some embodiments.
  • pre-forming or pre-shaping the body of a guidewire can introduce excess force or trauma on the vessel walls as the guidewire is navigated through the vasculature to a target site.
  • the substantially straight, and flexible body of the guidewire 102 therefore reduces the risk of excess force or trauma on the vessel walls.
  • the varying levels of flexibility/rigidity provided by the guidewire 102 allow the guidewire 102 – when pushed against tissue within the body – to conform to the geometry of the tissue.
  • this allows the guidewire placed within the left ventricle via the aortic valve to conform to the geometry of the B&A Docket No.4146.002PCT1 aortic arch and to the geometry of the left ventricle to securely anchor the guidewire 102 within the left ventricle as desired for various procedures (e.g., transcatheter aortic valve replacement (TAVR) procedure).
  • TAVR transcatheter aortic valve replacement
  • the flexibility/rigidity of the guidewire 102 may be selectively controlled via the pitch of the wire coils, the diameter of the mandrel, and/or combinations of both.
  • the guidewire 102 includes at least a first electrode located at the distal end 106 of the guidewire 102.
  • the guidewire 102 includes a plurality of electrodes located at various axial positions along the length of the guidewire 102.
  • the one or more electrodes may be utilized for one or both of sensing (e.g., sensing electrophysiology signals, such as EKG signals) and pacing (e.g., generating an electrical signal to cause the contraction of the heart tissue).
  • a sense circuit 120 is connected to receive signals sensed by the one or more electrodes located on the guidewire 102 and utilized to sense electrocardiogram (EKG) signals.
  • a pulse generator 122 is configured to deliver pulses to one or more of the electrodes located on the guidewire 102.
  • a controller 124 is connected to provide control signals to one, or both of, the sense circuit 120 and the pulse generator 122.
  • the one or more electrodes located at various axial positions along the length of the guidewire 102 are located at least partially circumferentially around the one or more wire coils (e.g., one or more filars).
  • the one or more electrodes may be ring electrodes located at various positions along the length of the guidewire 102.
  • One or more conductive traces or wires may be connected to each electrode and may extend proximally within a lumen defined by the wire coils (e.g., one or more filars) and be connected to the sense circuit 120 and/or the pulse generator 122.
  • the proximal end 104 includes a grounding electrode configured to receive (or collect) a return pacing current from the pulse generator 122.
  • portions of the wire coils included as part of the guidewire are themselves utilized as the electrodes.
  • the guidewire 102 includes a B&A Docket No.4146.002PCT1 bifilar coil.
  • a single filar may be coated with an insulative coating, which has a portion of the wire ablated or removed to expose the conductive filar at select locations along the length of the guidewire 102.
  • Each exposed portion of the conductor associated with the guidewire acts as an electrode that can be utilized for sensing, pacing, or both sensing and pacing.
  • the first electric wire is coated with an insulating polymer, and the second wire uninsulated (bare or insulated with ablated sections of the wire) to allow for electrical conduction to be used for sensing and pacing.
  • the present subject matter can include a coated guidewire having hydrophilic or hydrophobic properties to aid in both electrical conduction and anatomical delivery.
  • the sense signals can be utilized to provide physicians with additional information regarding a procedure.
  • a procedure for example, in a TAVR procedure, the guidewire 102 is guided through the descending aorta, the aortic arch, the ascending aorta, through the aortic valve and into the left ventricle.
  • Signals sensed by the one or more electrodes and processed by the sense circuit 120 may be utilized to detect when various portions of the guidewire 102 enter the heart (i.e., the left ventricle).
  • the sensed signals may be utilized to detect if the electrodes are located internal or external to the heart.
  • the EKG signals sensed from within the heart display a polarity that is opposite to the polarity sensed from outside the heart.
  • FIG.2 is a diagrammatic view of a guidewire 202 having a plurality of segments 210, 212, and 214, each with varying levels of rigidity/flexibility positioned within the patient according to some embodiments.
  • the guidewire 202 is shown positioned within the descending aorta 203, the aortic arch 204, the ascending aorta 205, and located partially within the left ventricle 206.
  • the flexibility/rigidity of the guidewire 202 may vary along the axial length of the guidewire to accommodate the geometry/curves of the patient’s physiology.
  • the segment located within the aortic arch 204 may be more flexible than the guidewire segment 214 located within the ascending aorta 205 to accommodate the curve required to navigate the aortic arch 204.
  • the curve of the guidewire segment 212 within the aortic arch is referred to herein as the first “virtual curve”, as the flexibility of the guidewire segment 212 allows the guidewire to conform to the geometry of the aortic arch 204.
  • a distal segment including the spiral segment 216 may be more flexible to accommodate a second U-shaped curve of the guidewire 202 within the left ventricle.
  • first segment 210 (proximal segment) has a first stiffness
  • second segment 212 has a second stiffness
  • third segment 214 has a third stiffness.
  • the first stiffness is greater than (i.e., stiffer) than the second stiffness and the third stiffness.
  • the third stiffness is greater than the second stiffness. That is, the second segment 212 extending through the aortic arch 204 is the most flexible to allow the guidewire202 to conform to the bend of the aortic arch 204.
  • the benefit of providing a guidewire 202 with varying levels of flexibility/rigidity along the length of the guidewire is that the uninserted guidewire may be approximately straight (i.e., not preformed curves) and the portions of the guidewire required to bend and conform to the physiology of the patient may be made more flexible at those axial locations. That is, the guidewire segment 212 B&A Docket No.4146.002PCT1 located in the aortic arch is not required to have a pre-formed curve to accommodate the geometry of the arch. Rather, the guidewire segment 212 – being more flexible than adjacent segments – is able to conform to the geometry of the aortic arch, which is desirable for ensuring the guidewire 202 is securely anchored.
  • the guidewire 202 further includes a spiral segment 216 located at a distal end of the guidewire 202 (i.e., distal to the third segment 214).
  • the spiral segment 216 of the present subject matter facilitates tracking and placement through the anatomy by allowing conformance to the anatomy and reduces stress due to vessel straightening while in use.
  • the spiral segment 216 allows conformation to the anatomy thereby reducing trauma, enhancing push ability, and reduction of buckling.
  • the spiral segment 216 is disposed proximal to the distal tip of one example of the present subject matter.
  • the configuration disclosed maintains electrical conductivity and enables uninterrupted monitoring by allowing position against the vessel wall to be maintained (for example, against the wall of the left ventricle 206 shown in FIG.2). These aspects also reduce the likelihood or incidence of perforating the ventricular wall during a placement procedure.
  • This spiral segment 216 has utility in several structures of the human anatomy and can be modified to conform to those structures. [0030]
  • the core or mandrel (shown in FIGS.5-6) extends distally beyond the ring coils, wherein an atraumatic tip of the mandrel is exposed.
  • the atraumatic tip (along with the rest of the mandrel) is conductive and can be utilized as an electrode to enable sensing of electrical and physiological signals as well as delivery of pacing therapy to tissue located adjacent to the atraumatic tip.
  • the sensed signals can be associated with potential complications of catheter-based cardiac procedures, such as arrythmias (conduction block, arrhythmogenic maneuvers).
  • the sensed signals can be associated with structural complications (such as left ventricular) or other chamber injury or perforation, or other structural injury (for example) valvular perforation or injury.
  • FIG.3 is a cross-sectional view of a heart with the guidewire 202 illustrating formation of a second “virtual curve” 300 that allows the guidewire 202 to conform to the geometry of the left ventricle 206.
  • the spiral segment 216 and second “virtual curve” 300 facilitates anchoring within the anatomy. Anchoring entails maintaining a selected, stabilized position via vessel apposition and conformance for the operator performing a procedure thereby reducing both procedural time and risks associated with movement against delicate tissues as evidenced with current wires.
  • the spiral segment 216 is configured to be positioned such that the walls of the heart will not exert compressive forces upon the spiral segment 216.
  • the spiral segment 216 is positioned within a left ventricle 206 (i.e., below the aortic valve)—but does not contact the apex 209 of the left ventricle 206. If, for instance, the spiral segment 216 was positioned in the apex 209, the compressions of the heart (cardiac motion) would compress, and cause friction with, the spiral segment 216, potentially leading to damage of the cardiac tissue.
  • the distal end i.e., the third segment 214, may include a predetermined shape so as to orient the spiral segment 216 away from the apex 209, e.g., as shown in FIG.3.
  • FIG.4 is a side view of a bifilar guidewire 402 having a first filar element 408 and a second filar element 410 wound about a center axis at various pitches according to some embodiments.
  • the first filar element 408 is an insulated conductive element and the second filar element 410 is not insulated (i.e., bare conductive elements).
  • the first and second filar elements 408, 410 provide an electrical connection that can be used for sensing, pacing or both sensing and pacing.
  • the insulation surrounding the first filar element 408 is a polymer such as polytetrafluoroethylene (PTFE) or other insulative coatings.
  • PTFE polytetrafluoroethylene
  • portions of the insulative coating on the first filar element 408 may be ablated/removed to expose the underlying conductive element.
  • the exposed conductive element may be utilized for B&A Docket No.4146.002PCT1 sensing/pacing operations.
  • the second filar element 410 being non-insulated, may also be utilized for sensing/pacing operations.
  • Electrical conductivity can include a physical electrical coupling between one or more of the filars of the coil and the tissue of the body. Electrical conductivity allows for sensing electrical activity detected at the tissue site.
  • an instrument e.g., sense circuit 120 shown in FIG.1 coupled to the coil is configured to process the sensed signal and generate an output including meaningful information regarding tissue and chamber parameters, electrical characteristics, or other characteristics associated with the tissue.
  • the instrument can include a processor or circuitry to analyze the sensed electrical signal and generate an output.
  • a sensed signal such as a PQRS electrocardiographic signal, can be useful for predicting a condition known as heart block.
  • one or more electrodes 412a, 412b, and 412c are affixed to the outer circumference of the first and second filar elements 408, 410.
  • electrodes 412a, 412b, and 412c are ring electrodes that circumscribe the first and second filar elements 408, 410.
  • the outer circumference of the electrodes 412a, 412b, and 412c is greater than that of the outer circumference of the first and second filar elements 408, 410.
  • the electrodes 412a, 412b, and 412c are likely to be in contact with adjacent tissue.
  • one or more wires connected to each of the plurality of electrodes 412a, 412b, and 412c extend proximally through the lumen defined by the first and second filar elements 408, 410. Signals sensed by each of the plurality of electrodes 412a, 412b, and 412c are communicated to the sense circuit 120 via the plurality of wires.
  • the plurality of electrodes 412a, 412b, and 412c may be selected to deliver pulses provided by the pulse generator 122.
  • the flexibility/rigidity of the guidewire 402 is modified by changing the pitch at which the first and second filar elements 408, 410 are wound around the center axis.
  • a first segment 404 of the guidewire 402 has a first B&A Docket No.4146.002PCT1 winding pitch
  • a second segment 405 has a second winding pitch
  • a third segment 406 has a third winding pitch.
  • the first winding pitch is shorter than the second winding pitch, meaning that the coils of the first winding are packed together more tightly and therefore provide greater rigidity than the second winding pitch.
  • a mandrel shown in FIG. 5
  • the flexibility of the guidewire 402 may also be modified by modifying the diameter of the mandrel located within the lumen of the first and second filar elements 408, 410.
  • the first and second filar elements 408, 410 are configured to provide rigidity along an axial direction (i.e., parallel to the winding axis of the first and second filar elements 408, 410), and compliance or flexibility along all other directions. For instance, the adjacent windings of the first and second filar elements 408, 410 engage each other when compressed in an axial direction—thereby providing rigidity and support, however, in any direction non-parallel to the axial direction, the adjacent windings of the first and second filar elements 408, 410 will not engage each other, according to some embodiments.
  • FIG.5 is a side view of a mandrel 500 according to some embodiments.
  • the mandrel may be utilized as a core positioned within the lumen defined by the one or more filar elements.
  • the mandrel 500 is included along the entire length of the guidewire. In other embodiments, the mandrel 500 may be positioned along only a portion of the length of the guidewire.
  • the mandrel is comprised of various segments having varying diameters. Varying the diameter of the mandrel 500 provides varying flexibility/rigidity characteristics among the various segments, with the larger diameter segments (e.g., first and second segments 502, 504) having a greater rigidity than the smaller diameter segments (e.g., third, fourth, and fifth segments 506, 508, 510).
  • proximal segment 502 has the largest diameter, which remains constant along the axial length of the segment.
  • Second segment 504 has a decreasing diameter along the axial length of the segment.
  • a decreasing diameter provides a varying flexibility/rigidity along the axial length of the segment.
  • Third segment 506 has a constant diameter that is less than that of the first segment 502 and most of the second segment 504.
  • Fourth segment 508 has a decreasing diameter along the axial length of the segment, which provides a varying flexibility/rigidity along the axial length.
  • Fifth or distal segment 510 has a constant diameter that is smaller than the diameter of the other segments. In the embodiment shown in FIG.5, the diameters of the segments decrease toward the distal end of the mandrel 500. In other embodiments, the diameters of the segments may decrease or increase along the axial length of the mandrel 500 depending on the desired flexibility/rigidity.
  • the mandrel includes an atraumatic tip 512 that may extend beyond the coil wires (i.e., may be exposed, distal of the coil wires). The atraumatic tip 512 is designed to prevent puncturing adjacent tissue.
  • the atraumatic tip 512 may be conductive and may be utilized as an electrode for sensing and/or pacing.
  • mandrel is conductive and may communicate signals from the sense circuit 120 and/or pulse generator 122.
  • the mandrel 500 is insulated to prevent electrical conductivity between the mandrel 500 and one or more filar elements (such as those shown in FIG.4).
  • the mandrel 500 may be fabricated from various conductive materials, such as stainless steel. In some embodiments, the mandrel 500 can include series 304 stainless steel.
  • FIG.6 is a side view of a distal end 604 of the sensor-enabled guidewire 600, according to some embodiments.
  • the sensor-enabled guidewire 600 includes an elongate body 602 disposed between a proximal end (not shown) and the distal end 604.
  • the distal end 604 of the sensor-enabled guidewire 600 includes a distal tip 612 and is spiral- wound.
  • the distal end 604 includes a rotation of at least 536°.
  • the distal end 604 includes a rotation of approximately 540°, or 1.5 rotations (the term “approximately” referring to ⁇ 30° in this case).
  • the distal end 604 is spiral-wound to have a rotation between 324° and 539°.
  • the distal end 604 is spiral-wound to have a rotation between 536° and 1440°.
  • the distal end 604 is spiral-wound to have a first dimension 606 and a second dimension 608, and in some embodiments, the second dimension 608 is greater than the first dimension 606. [0041]
  • the spiral winding of the distal end 604 enables atraumatic anchoring of the sensor-enabled guidewire 600 in the heart (e.g., in the left ventricle).
  • the distal tip 612 of the sensor-enabled guidewire 600 is nestled within, or central to, the spiral winding of the distal end 604—and thereby positioned away from the cardiac wall where it could cause trauma if insertion forces are too high.
  • the distal tip 612 of the sensor-enabled guidewire 600 is the bare or exposed mandrel (e.g., the mandrel 500), as the filar windings end proximal to the distal tip 612.
  • the distal tip 612 (and thereby the distal tip of the mandrel 500) is atraumatic, including rounded edges configured to reduce the probability of perforation.
  • the outer spiral winding of the distal end 604 engages with and/or makes intimate contact with the wall of the heart.
  • the insertion forces of the sensor-enabled guidewire 600 acting on the heart are distributed over a larger surface area (i.e., across the outer spiral winding of the distal end 604).
  • the distal tip of the guidewire may transfer the entire insertion load force and/or anchoring force to the cardiac tissue at a single point (and parallel to the angle of insertion into the heart), thereby increasing the risk of perforation.
  • the spiral winding of the distal end 604 distributes the insertion load force and/or anchoring force B&A Docket No.4146.002PCT1 over a larger area and/or at an angle non-parallel to the insertion angle, thereby reducing the possibility of perforation of the cardiac tissue.
  • the degree of rotation of the spiral-wound distal end 604 and/or the respective sizes of the first dimension 606 and the second dimension 608 can be configured for different anatomical sizes of the heart (e.g., based on patient size).
  • the spiral-wound distal end 604 of the sensor-enabled guidewire 600 conforms to the geometry of the cardiac tissue, and in some embodiments, is compliant as the cardiac tissue expands and contracts during cardiac rhythm.
  • the first dimension 606 is between 25mm and 60mm, according to some embodiments.
  • the second dimension 608 is between 25mm and 80mm, according to some embodiments.
  • the first dimension 606 and the second dimension 608 is a pre-shaped curve, according to some embodiments.
  • the sensor-enabled guidewire 600 includes a plurality of electrodes 610 positioned along the elongate body 602 and the distal end 604. In some embodiments, each of the plurality of electrodes 610 are electrically coupled to a conductor (or wire) running along the sensor-enabled guidewire 600.
  • each of the plurality of electrodes 610 may be configured to sense impedance (e.g., in association with an impedance-based medical positioning system) and/or electrophysiology signals such as cardiac voltage, cardiac activation, cardiac timing, EKG signals, etc.
  • a sensing circuit e.g., the sensing circuit 120
  • the plurality of electrodes 610 are electrically coupled to a pacing generator (e.g., the pulse generator 122), according to some embodiments.
  • the plurality of electrodes 610 are configured to output a pacing current to cardiac tissue.
  • two or more of the plurality of electrodes 610 are coupled to the pacing generator via a single B&A Docket No.4146.002PCT1 (shared) conductive wire.
  • the plurality of electrodes 610 includes a first set of electrodes for pacing and a second set of electrodes for sensing.
  • each of the plurality of electrodes 610 are configured to both sense electrophysiology signals and output pacing signals.
  • the outer spiral winding of the distal end 604 engages with and/or makes intimate contact with the wall of the heart (e.g., with the walls of the left ventricle), and thereby enables intimate contact between the plurality of electrodes 610 and the cardiac tissue. Intimate and sustained contact between the plurality of electrodes 610 with the cardiac tissue is beneficial, as it improves accuracy for sensing electrophysiology signals and/or improves delivery of pacing signals to the cardiac tissue.
  • the distal tip 612 includes a distal electrode (not shown).
  • the distal tip 612 of the sensor-enabled guidewire 600 is nestled within, or central to, the spiral winding of the distal end 604—and thereby positioned away from the cardiac wall.
  • FIG.7 is a schematic view of a distal end 700 of a sensor-enabled guidewire 702, according to some embodiments.
  • the distal end 700 is configured to be inserted into the left ventricle through the aortic valve, according to some embodiments.
  • the distal end 700 of the sensor-enabled guidewire 702 is compliant and forms to the structure of the surrounding tissue. For instance, as illustrated in FIG.9, the distal end 700 includes a first portion 704 having a radius of curvature (ROC) 710.
  • ROC radius of curvature
  • the first portion 704 is deflected via the walls of the left ventricle, with the first portion 704 extending toward an apex of the left ventricle and a second portion 706 extending toward the aortic valve.
  • the ROC 710 of the first portion 704 is between 25mm and 85mm, and in some embodiments the ROC 710 of the first portion 704 is between 40mm and 60mm.
  • the second portion 706 includes a length 712. In some embodiments, the length 712 is less than a length of the left ventricle.
  • the distal end 700 of the sensor-enabled guidewire 702 includes a spiral 708 and a distal tip 714.
  • the compliancy and/or flexibility of the distal end 700 of the sensor- B&A Docket No.4146.002PCT1 enabled guidewire 702 is configured to aid proper positioning of the spiral 708 and the distal tip 714. For instance, positioning the spiral 708 and/or the distal tip 714 at the apex of the left ventricle may damage or perforate the cardiac tissue as it compresses against the sensor-enabled guidewire 702 (see e.g., FIG.3). Further, positioning the distal tip 714 outside of the spiral 708 may result in the distal tip 714 contacting the mitral valve and/or other valve structures, leading to damage or perforation.
  • FIG.8 is a side view of a sensor-enabled guidewire 800 having a distal end 804 with an elliptical geometry, according to some embodiments.
  • the sensor-enabled guidewire 800 includes a body 802 disposed between a proximal end (not shown) and the distal end 804.
  • the distal end 804 of the sensor-enabled guidewire 800 includes a distal tip and is spiral-wound with an elliptical geometry.
  • the distal end 804 includes a first dimension 806 and a second dimension 808. In some embodiments, the first dimension 806 is greater than the second dimension 808 by a factor of between 1.1 and 2.5. In some embodiments the first dimension 806 is greater than the second dimension 808 by a factor of between 1.25 and 1.75.
  • the elliptical geometry, or the oblong shape, of the distal end 804 provides an improved anchor retention, according to some embodiments. For instance, the elliptical geometry of the distal end 804 is configured to conform to the elliptical geometry of the apex of the left ventricle, according to some embodiments.
  • the distal end 804 may include any and/or all features of the distal ends 604, 700 described above.
  • FIG.9 is an isometric view of a guide wire connector 900, according to some embodiments.
  • the guide wire connector 900 includes a guidewire entry port 902, a connection indicator 908, a first wing 904, and a second wing 906, according to some embodiments.
  • the guide wire connector 900 is configured to connect a pacing generator and/or a sensing unit to the guidewire.
  • the guidewire (e.g., including any and/or all features of guidewires 102, 202, 600, 702, 800) is received within the B&A Docket No.4146.002PCT1 guidewire entry port 902, and the conductive element of the guidewire is connected to a pacing unit and/or a sensing unit positioned on an opposite end of the guidewire entry port 902.
  • the connection indicator 908 is configured to provide an indication of an electrical connection between the conductive element of a guidewire and the pacing unit and/or sensing unit.
  • the connection indicator 908 includes a light emitting diode (LED) to indicated whether the conductive element of a guidewire is coupled with a pacing unit and/or sensing unit.
  • LED light emitting diode
  • FIG.10 is an isometric view of a ground spike 1000, according to some embodiments.
  • the ground spike 1000 includes a conductor exit port 1002, a flange 1006 positioned at a proximal end, a body 1012 extending to a distal end 1010, a channel 1004 extending through the body 1012, and an exposed connection pad 1008 including a first electrical trace 1014 and a second electrical trace 1016.
  • the body 1012 of the ground spike 1000 is inserted into the entry site tissue (e.g., at the incision site), and in some embodiments, the distal end 1010 and the body 1012 of the ground spike 1000 extend into a vein or artery (e.g., the femoral artery). In some embodiments, the body 1012 is taped, with the distal end 1010 defining a smaller area than the area adjacent to the flange 1006.
  • the flange 1006 provides a stop surface to prevent full insertion of the ground spike 1000 into the patient, i.e., the flange 1006 remains outside of the incision site.
  • a guidewire including any and/or all features of the guidewires 102, 202, 600, 702, 800 is inserted through the channel 1004 and out the distal end 1010 of the ground spike 1000, according to some embodiments.
  • a guidewire including one or more electrodes for pacing of the heart i.e., electrodes coupled to a pacing generator, are inserted through the channel 1004 and navigated to a treatment site.
  • the exposed connection pad 1008 is in contact with a blood pool of the vein or artery, and in some embodiments, the exposed connection pad 1008 is in contact with tissue or other bodily fluids.
  • the exposed connection pad 1008 including the first electrical trace 1014 and the second electrical trace 1016, is configured to receive return B&A Docket No.4146.002PCT1 current from the pacing electrodes, and thereby provide a grounding for the pacing generator.
  • a guidewire including one or more electrodes and a conductive element 1022 coupled to a pacing unit 1020 for pacing of the heart is inserted through the channel 1004, and provides pacing current to the cardiac tissue.
  • the return pacing current travels through the blood stream and/or other tissue to be collected by the exposed connection pad 1008.
  • the exposed connection pad 1008 is formed of conductive material, whereas the body 1012 of the ground spike 1000 is formed of an insulative material (e.g., PTFE).
  • the conductor exit port 1002 is coupled to a return conductor 1024, which is electrically coupled to the exposed connection pad 1008.
  • the return pacing current is collected by the first electrical trace 1014, the second electrical trace 1016 and/or the exposed connection pad 1008 and exits the ground spike 1000 through the conductor exit port 1002.
  • the return conductor 1024 is coupled to a pacing return 1018, which provides a ground for the return pacing current.
  • the ground spike 1000 is beneficial, as it provides a stable and sterile entry point for a pace-enabled guidewire (e.g., such as the guidewires 102, 202, 600, 702, 800 described above) via the channel 1004, an in-body return current collection via the exposed connection pad 1008, and a return current exit port via the conductor exit port 1002.
  • a pace-enabled guidewire e.g., such as the guidewires 102, 202, 600, 702, 800 described above
  • the pacing signal travels through the ground spike 1000 (via the conductive element 1022), the return current is collected by the ground spike 1000 (via the exposed connection pad 1008), and the return current exits the ground spike 1000 (via the conductor exit port 1002 and/or the return conductor 1024).
  • FIG.11 is a flow chart for a method of pacing cardiac rhythm with a guidewire, according to some embodiments.
  • the method 1100 includes sensing electrophysiology (EP) signals with a plurality of electrodes disposed on a distal end of a guidewire.
  • the guidewire includes any and/or all features of the B&A Docket No.4146.002PCT1 guidewire 102, 202, 600, 702, 800 described above.
  • the method 1100 includes determining contract status of the plurality of electrodes based on the sensed electrophysiology signals. In some embodiments, the controller 124 and/or the sensing circuit 120 determines contact status of each electrode. At step 1130, the method 1100 includes selectively outputting a pacing signal based on the determined contact status of each of the plurality of electrodes. In some embodiments, the pacing signal is provided solely to electrodes that are in-contact with the target tissue. The pacing signal is generated by the pulse generator 122, according to some embodiments.
  • the techniques described herein relate to a guidewire, including: a proximal end; a distal end that includes a spiral segment that includes an electrode and a distal tip; a filar element wound around a central axis that extends from the proximal end to the distal end to form a filar winding; and a mandrel located within a lumen defined by the filar element, wherein characteristics of one or both of the filar winding and the mandrel are varied along an axial length to modify flexibility/rigidity characteristics of the guidewire along an axial length.
  • the techniques described herein relate to a guidewire, wherein the spiral segment has a rotation of at least 536°.
  • the techniques described herein relate to a guidewire, wherein the mandrel extends in an axial direction distal to the filar winding, wherein a portion of the mandrel that extends axially beyond the filar winding is the distal tip of the guidewire. [0061] In some aspects, the techniques described herein relate to a guidewire, wherein the portion of the mandrel that extends axially beyond the filar winding is utilized as the electrode. [0062] In some aspects, the techniques described herein relate to a guidewire, wherein the electrode is configured to sense one or more electrophysiology signals, and wherein the electrode is configured to output a pacing signal.
  • the techniques described herein relate to a guidewire, wherein the spiral segment of the distal tip includes an elliptical geometry having a first dimension and a second dimension, wherein the first dimension is greater than the second dimension by a factor of between 1.1 and 2.5.
  • the techniques described herein relate to a guidewire, wherein a rotation of the spiral segment is between 536° and 1440°, wherein a first dimension of the spiral segment is between 25mm and 60mm and second dimension of the spiral segment is between 25mm and 80mm.
  • the techniques described herein relate to a guidewire, wherein the guidewire disposed between the proximal end and the distal end proximal to the spiral segment does not include predetermined curves.
  • the techniques described herein relate to a guidewire, wherein the guidewire includes a first segment for traversing a descending thoracic aorta, a second segment for traversing an aortic arch, and a third segment for traversing an ascending aorta, wherein the first segment is more rigid than the second segment and the third segment.
  • the techniques described herein relate to a guidewire, wherein the guidewire includes a first segment and a second segment, wherein a first width of the B&A Docket No.4146.002PCT1 mandrel at the first segment is greater than a second width of the mandrel at the second segment.
  • the techniques described herein relate to a guidewire, wherein a first pitch of the filar winding at the first segment is greater than a second pitch of the filar winding at the second segment.
  • the techniques described herein relate to a guidewire further including a second filar element wound with the filar element around the mandrel.
  • the techniques described herein relate to a guidewire, wherein the filar winding is insulated, wherein portions of the insulation located are removed to expose a conductive element of the filar winding to act as the electrode. [0071] In some aspects, the techniques described herein relate to a guidewire, wherein the guidewire includes a plurality of electrodes at different axial locations along a selected length of the guidewire. [0072] In some aspects, the techniques described herein relate to a guidewire, wherein the plurality of electrodes are located on an outer surface of the filar winding and at a circumferential location greater than that of the filar winding.
  • the techniques described herein relate to a medical system, including: a guidewire including: a proximal end, a distal end that includes a spiral segment that includes an electrode, a filar element wound around a central axis that extends from the proximal end to the distal end to form a filar winding, and a mandrel located within a lumen defined by the filar element; and a ground spike including a body having an exposed connection pad and a channel extending therethrough, wherein the guidewire extends through the channel and delivers electrical pulses provided by a pulse generator to the electrode, wherein the exposed connection pad provides a return path to the pulse generator.
  • the techniques described herein relate to a medical system, wherein the exposed connection pad includes one or more electrical traces configured to provide the return path to the pulse generator. B&A Docket No.4146.002PCT1 [0075] In some aspects, the techniques described herein relate to a medical system, wherein the ground spike includes a conductor exit port electrically coupled to the exposed connection pad and configured to receive a terminal connected to provide the return path to the pulse generator. [0076] In some aspects, the techniques described herein relate to a medical system, further including a sensing unit electrically coupled to the electrode, the sensing unit configured to receive a sensed signal from the electrode.
  • the techniques described herein relate to a medical system, wherein the distal end includes a spiral winding and a distal tip, wherein the distal tip is positioned radially inward from the spiral winding of the distal end.
  • the techniques described herein relate to a method of pacing cardiac rhythm with a guidewire, the method including: sensing electrophysiology (EP) signals with one or more electrodes disposed on the guidewire, the guidewire including: a mandrel; a filar element wound around the mandrel; and one or more electrodes located at various axial locations along a length of the guidewire determining contact status of the one or more electrodes based on the sensed EP signals; and selectively outputting a pacing signal to selected electrodes based on the determined contact status of the one or more electrodes.
  • EP electrophysiology
  • the techniques described herein relate to a method, wherein the contact status of the one or more electrodes is determined by a sensing unit and wherein the pacing signal is generated by a pacing unit.
  • the techniques described herein relate to a method, wherein the EP signals include one or more of an impedance, an electrocardiogram (EKG) and/or voltage.
  • the techniques described herein relate to a method, wherein the pacing signal is output to at least one of the plurality of electrodes in-contact with tissue.

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Abstract

L'invention concerne un fil-guide, comprenant une extrémité proximale et une extrémité distale. L'extrémité distale comprend un segment en spirale et une pointe distale. Un élément filaire est enroulé autour d'un axe central qui s'étend de l'extrémité proximale à l'extrémité distale pour former un enroulement filaire. Un mandrin est situé à l'intérieur d'une lumière définie par l'élément filaire. Les caractéristiques de l'enroulement filaire et/ou du mandrin varient le long d'une longueur axiale pour modifier les caractéristiques de flexibilité/rigidité du fil-guide le long d'une longueur axiale. Une électrode est située le long d'une longueur du fil-guide.
PCT/US2024/052064 2023-10-19 2024-10-18 Fil-guide Pending WO2025085811A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363544901P 2023-10-19 2023-10-19
US63/544,901 2023-10-19

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WO2025085811A1 true WO2025085811A1 (fr) 2025-04-24

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5846210A (en) * 1996-09-20 1998-12-08 Kaneka Medix Corporation Medical wire having implanted device and method for using the same
WO2000062851A1 (fr) * 1999-04-20 2000-10-26 C.R. Bard, Inc. Fil-guide d'electrophysiologie et procede de fabrication correspondant
US20030139689A1 (en) * 2001-11-19 2003-07-24 Leonid Shturman High torque, low profile intravascular guidewire system
US20110071608A1 (en) * 2009-09-23 2011-03-24 Lake Region Manufacturing, Inc. d/b/a Lake Region Medical Guidewire-style pacing lead
US20220118232A1 (en) * 2016-07-19 2022-04-21 Asahi Intecc Co.,Ltd. Guidewire assembly and method of making

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5846210A (en) * 1996-09-20 1998-12-08 Kaneka Medix Corporation Medical wire having implanted device and method for using the same
WO2000062851A1 (fr) * 1999-04-20 2000-10-26 C.R. Bard, Inc. Fil-guide d'electrophysiologie et procede de fabrication correspondant
US20030139689A1 (en) * 2001-11-19 2003-07-24 Leonid Shturman High torque, low profile intravascular guidewire system
US20110071608A1 (en) * 2009-09-23 2011-03-24 Lake Region Manufacturing, Inc. d/b/a Lake Region Medical Guidewire-style pacing lead
US20220118232A1 (en) * 2016-07-19 2022-04-21 Asahi Intecc Co.,Ltd. Guidewire assembly and method of making

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