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WO2025231292A1 - Shuntage sans implant - Google Patents

Shuntage sans implant

Info

Publication number
WO2025231292A1
WO2025231292A1 PCT/US2025/027374 US2025027374W WO2025231292A1 WO 2025231292 A1 WO2025231292 A1 WO 2025231292A1 US 2025027374 W US2025027374 W US 2025027374W WO 2025231292 A1 WO2025231292 A1 WO 2025231292A1
Authority
WO
WIPO (PCT)
Prior art keywords
wire
tissue wall
catheter
electrocautery
shunt
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/US2025/027374
Other languages
English (en)
Inventor
Roei MAYO
John Charles LASCHINGER
Noam Miller
Amir Davidesko
Aviv GALON
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.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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 Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025231292A1 publication Critical patent/WO2025231292A1/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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00607—Coagulation and cutting with the same instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/144—Wire

Definitions

  • the present disclosure relates generally to shunts, and, in particular, to devices, systems, and methods for forming implantless shunts.
  • Heart failure also known as congestive heart failure
  • diastolic heart failure also known as heart failure with preserved ejection fraction, or HFpEF
  • HFpEF heart failure with preserved ejection fraction
  • Diastolic heart failure is characterized by a stiff left ventricle with decreased compliance and impaired relaxation, which leads to increased end-diastolic pressure, which in turn causes an elevation in pressure in the left atrium. Symptoms of diastolic heart failure are due, at least in a large part, to this elevation in pressure in the left atrium. Both HFpEF and heart failure with reduced ejection fraction (HFrEF) can exhibit elevated left atrial pressure (LAP). Elevated LAP is also present in several other abnormal heart or other medical conditions in addition to heart failure, including systolic dysfunction of the left ventricle and certain forms of congenital heart and valve disease.
  • a device for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular body and the nosecone, and at least one clcctrocautcry wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current.
  • the device is configured to be inserted through an opening in the tissue wall.
  • the elongate tubular body is retractable away from the nosecone to expose the at least one electrocautery wire.
  • the at least one electrocautery wire is rotatable to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • a system for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes a shunting device including an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular body and the nosecone, and at least one electrocautery wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current.
  • the system may further include at least one independent pressure sensor that may be configured to be positioned proximal to, distal to, and/or adjacent to the shunting device within the cardiovascular system of the patient during a shunt formation procedure for the patient.
  • the shunting device is configured to be inserted through an opening in the tissue wall.
  • the elongate tubular body is retractable away from the nosecone to expose the at least one electrocautery wire.
  • the at least one electrocautery wire is rotatable to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • a system for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes a first catheter configured to be inserted along a first side of the tissue wall and a second catheter configured to be inserted along a second side of the tissue wall opposite the first side of the tissue wall.
  • the first catheter includes a first magnet configured to face the first side of the tissue wall when the first catheter is inserted along the first side of the tissue wall and including a wire passage therethrough, and an extrudable wire.
  • the second catheter includes a second magnet configured to face the second side of the tissue wall when the second catheter is inserted along the second side of the tissue wall and including a wire receiver therein.
  • the first magnet and the second magnet are configured to be aligned across the tissue wall when the first catheter and the second catheter are inserted along respective sides of the tissue wall.
  • the extrudable wire is configured to be advanced through the first catheter and extruded through the wire passage in the first magnet to cut through the tissue wall and be captured in the wire receiver of the second magnet. Cutting through the tissue wall with the extrudable wire forms a patent shunt through the tissue wall.
  • a method of forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes creating an opening in the tissue wall and advancing a shunting device partially through the opening in the tissue wall, the shunting device including an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular body and the nosecone, and at least one electrocautery wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current.
  • the nosecone and the distal portion of the elongate tubular body are advanced through the opening in the tissue wall.
  • the method further includes retracting the elongate tubular body away from the nosecone to expose the at least one electrocautery wire and rotating the at least one electrocautery wire to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • a method of forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes inserting a first catheter along a first side of the tissue wall and inserting a second catheter along a second side of the tissue wall opposite the first side of the tissue wall.
  • the first catheter includes a first magnet configured to face the first side of the tissue wall when the first catheter is inserted along the first side of the tissue wall and including a wire passage therethrough, and an extrudable wire.
  • the second catheter includes a second magnet configured to face the second side of the tissue wall when the second catheter is inserted along the second side of the tissue wall and including a wire receiver therein.
  • the method further includes aligning the first magnet and the second magnet across the tissue wall when the first catheter and the second catheter are inserted along respective sides of the tissue wall, extruding the extrudable wire through the wire passage in the first magnet, cutting through the tissue wall with the extrudable wire to form a patent shunt through the tissue wall, and capturing the extrudable wire in the wire receiver of the second magnet after cutting through the tissue wall.
  • An example of a method of forming a shunt in a tissue wall between a left atrium and a coronary sinus includes advancing a first guide wire into the coronary sinus, advancing a second guide wire into the left atrium, advancing a first catheter into the coronary sinus over the first guide wire, and advancing a second catheter into the left atrium over the second guide wire.
  • the first catheter includes a magnetic attractor at a distal end and the second catheter includes a magnetic capsule at a distal end.
  • the method further includes aligning the magnetic attractor on the first catheter with the magnetic capsule on the second catheter, advancing a puncture catheter through a lumen of the second catheter, and puncturing the tissue wall with a puncture tip of the puncture catheter to form the shunt between the left atrium and the coronary sinus.
  • FIG. 1 is a schematic diagram of a heart and vasculature.
  • FIG. 2 is a schematic cross-sectional view of the heart.
  • FIG. 3A is a schematic cross-sectional side view of a first example of an electrocautery shunting device extending through an opening in a tissue wall.
  • FIG. 3B is a schematic cross-sectional front view of the first example of the electrocautery shunting device extending through the opening in the tissue wall taken at line 3B- 3B of FIG. 3A and showing a distal portion of an elongate tubular body surrounding an electrocautery wire and a guidewire.
  • FIG. 4A is a schematic cross-sectional side view of the first example of the electrocautery shunting device extending through the opening in the tissue wall and showing retraction of the elongate tubular body.
  • FIG. 4B is a schematic cross-sectional front view of the first example of the electrocautery shunting device extending through the opening in the tissue wall taken at line 4B- 4B of FIG. 4A and showing the tissue wall closed against the electrocautery wire and the guide wire.
  • FIG. 5 is a schematic cross-sectional front view of the first example of the electrocautery shunting device extending through the opening in the tissue wall and showing a radial cut.
  • FIG. 6A is a schematic cross-sectional side view of the first example of the clcctrocautcry shunting device extending through the opening in the tissue wall and showing partial rotation of the device.
  • FIG. 6B is a schematic cross-sectional front view of the first example of the electrocautery shunting device extending through the opening in the tissue wall taken at line 6B- 6B of FIG. 6A and showing a partial circumferential cut.
  • FIG. 6C is a schematic top-down view of a shunt with a tissue flap cut via the partial rotation of the device shown in FIG. 6A.
  • FIG. 7A is a schematic cross-sectional side view of the first example of the electrocautery shunting device extending through the opening in the tissue wall and showing full rotation of the device.
  • FIG. 7B is a schematic cross-sectional front view of the first example of the electrocautery shunting device extending through the opening in the tissue wall taken at line 7B- 7B of FIG. 7A and showing a full circumferential cut.
  • FIG. 7C is a schematic cross-sectional side view of the first example of the electrocautery shunting device showing a shunt cut via the full rotation of the device shown in FIG. 7A.
  • FIG. 8 is a schematic front view of a tissue segment cut using an attached electrocautery wire.
  • FIG. 9 is a schematic cross-sectional side view of a second example of the electrocautery shunting device extending through the opening in the tissue wall and including a proximally tapered nosecone and an unattached electrocautery wire.
  • FIG. 10 is a schematic front view of a tissue ring cut using the unattached electrocautery wire of FIG. 9.
  • FIG. 11 is a schematic cross-sectional front view of a third example of the electrocautery shunting device extending through the opening in the tissue wall and showing an integrated sensor.
  • FIG. 12 is a schematic cross-sectional front view of a fourth example of the clcctrocautcry shunting device extending through the opening in the tissue wall and showing an independent sensor.
  • FIG. 13A is a schematic cross-sectional side view of a fifth example of the electrocautery shunting device extending through the opening in the tissue wall and including a multi-lumen shaft.
  • FIG. 13B is a schematic cross-sectional front view of the fifth example of the electrocautery shunting device taken at line 13B-13B of FIG. 13A showing an electrocautery wire in an electrocautery wire lumen and a guidewire in a guidewire lumen of the multi-lumen shaft.
  • FIG. 14A is a schematic cross-sectional side view of a sixth example of the electrocautery shunting device extending through the opening in the tissue wall and including a multi-lumen shaft and multiple electrocautery wires.
  • FIG. 14B is a schematic cross-sectional front view of the sixth example of the electrocautery shunting device taken at line 14B-14B of FIG. 14A showing clcctrocautcry wires in electrocautery wire lumens and a guidewire in a guidewire lumen of the multi-lumen shaft.
  • FIG. 15A is a schematic cross-sectional side view of a seventh example of the electrocautery shunting device extending through the opening in the tissue wall and including a multi-lumen shaft with multiple radial distance lumens for an electrocautery wire.
  • FIG. 15B is a schematic cross-sectional front view of the seventh example of the electrocautery shunting device taken at line 15B-15B of FIG. 15A showing the electrocautery wire in one radial distance lumen of the multiple radial distance lumens.
  • FIG. 16 is a schematic cross-sectional view of the heart showing a magnetic shunting system.
  • FIG. 18A is a schematic front perspective view of a first example of a first magnet and an extrudable wire of the magnetic shunting system.
  • FIG. 18B is a schematic front perspective view of a first example of a second magnet and a wire receiver that is complimentary to the cxtrudablc wire of FIG. 18 A.
  • FIG. 19A is a schematic front perspective view of a second example of a first magnet and an extrudable wire of the magnetic shunting system.
  • FIG. 19B is a schematic front perspective view of a second example of a second magnet and a wire receiver that is complimentary to the extrudable wire of FIG. 19A.
  • FIG. 20A is a schematic front perspective view of a third example of a first magnet and an extrudable wire of the magnetic shunting system.
  • FIG. 20B is a schematic front perspective view of a third example of a second magnet and a wire receiver that is complimentary to the extrudable wire of FIG. 20A.
  • FIG. 21 is a schematic cross-sectional side view of a combination shunting system.
  • FIG. 22 is a schematic cross-sectional side view of a first example of a magnetic attractor device suitable for use in a magnetic shunting system.
  • FIG. 23 is a schematic cross-sectional side view of a second example of a magnetic attractor device suitable for use in a magnetic shunting system.
  • FIG. 24 is a schematic cross-sectional side view of a third example of a magnetic attractor device suitable for use in a magnetic shunting system.
  • FIG. 25 is a schematic cross-sectional side view of an example of a magnetic capsule device suitable for use in a magnetic shunting system.
  • FIG. 26 is a schematic side view of a puncture catheter suitable for use with the magnetic capsule device of FIG. 25.
  • FIG. 27 is a schematic cross-sectional side view of an example of a magnetic capsule assembly including the magnetic capsule device of FIG. 25 and the puncture catheter of FIG. 26.
  • FIG. 28 is a schematic cross-sectional side view of an example of the magnetic shunting assembly of FIG. 27 including a delivery catheter and an implantable device.
  • FIG. 29 is a flow diagram of an example of a method of forming a shunt across a tissue wall using a magnetic shunting system.
  • FIG. 30A is a schematic cross-sectional side view of a heart showing a first guide wire extending into the left atrium and a second guide wire extending into the coronary sinus.
  • FIG. 30B is a schematic cross-sectional view of the heart of FIG. 29A and showing a magnetic attractor device extending into the coronary sinus.
  • FIG. 30C is a schematic cross-sectional view of the heart of FIG. 29B also showing a magnetic capsule device extending into the left atrium.
  • FIG. 30D is a schematic cross-sectional view of the heart of FIG. 29C showing the magnetic attractor device and the magnetic capsule device aligned across a tissue wall.
  • FIG. 30E is a schematic cross-sectional view of the heart of FIG. 29D showing a puncture catheter installed in the magnetic capsule device and the second guide wire removed.
  • FIG. 30F is a schematic cross-sectional view of the heart of FIG. 29E showing a shunt formed through the tissue wall by the puncture catheter and displacement of the magnetic attractor device by the puncture catheter.
  • FIG. 30G is a schematic cross-sectional view of the heart of FIG. 29F showing the magnetic capsule device extending through the shunt in the tissue wall.
  • FIG. 30H is a schematic cross-sectional view of the heart of FIG. 29G showing the puncture catheter removed from the magnetic capsule device and also showing the first guide wire and the magnetic attractor device removed from the coronary sinus.
  • FIG. 301 is a schematic cross-sectional view of the heart of FIG. 29H showing a third guide wire installed through the magnetic capsule device.
  • FIG. 30J is a schematic cross-sectional view of the heart of FIG. 291 showing the magnetic capsule device removed and the third guide wire extending into the coronary sinus from the left atrium via the shunt.
  • FIG. 31 is a schematic cross-sectional view of another example of a magnetic shunting system for forming a shunt in a tissue wall of a heart including an alternative puncture catheter.
  • shunting devices and systems can be used to create implantless shunts.
  • the shunting devices and systems described herein can utilize rotatable wires and/or magnetic alignment features to create implantless shunts.
  • implantless shunts can be created between anatomically adjacent chambers and/or vessels of the cardiovascular system, such as between the left atrium and coronary sinus, to shunt blood from a relatively higher-pressure chamber or vessel into a relatively lower-pressure chamber or vessel.
  • the shunting devices and systems described herein may be used to mitigate elevated LAP, for example, in patients experiencing heart failure or other medical conditions.
  • FIG. 1 is a schematic diagram of heart H and vasculature V.
  • FIG. 2 is a cross- sectional schematic view of heart H.
  • FIGS. 1-2 will be discussed together.
  • FIGS. 1-2 show heart H, vasculature V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, superior vena cava SVC, inferior vena cava IVC, pulmonary veins PVS, and mitral valve MV.
  • FIG. 1 further shows tricuspid valve TV, pulmonary valve PV, pulmonary artery PA, aortic valve AV, and aorta AT.
  • FIG. 2 further shows coronary sinus CS, thebesian valve BV, inter-atrial septum IS, and fossa ovalis FO.
  • Heart H is a human heart that receives blood from and delivers blood to vasculature V.
  • Heart H includes four chambers: right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV.
  • the right side of heart H, including right atrium RA and right ventricle RV, receives deoxygenated blood from vasculature V and pumps the blood to the lungs.
  • right-sided flow vortex in right atrium RA preserves kinetic energy and momentum of the major blood flows entering right atrium RA and allows a substantial portion of blood to naturally pass from right atrium RA to right ventricle RV without any contribution to flow needed from the pumping action of right atrium RA.
  • right atrium RA With contraction, right atrium RA also pumps the residual portion of the entering blood not caught in the direct flow through tricuspid valve TV into right ventricle RV. The blood enters right ventricle RV and then flows through pulmonary valve PV into pulmonary artery PA.
  • blood entering right ventricle RV also forms a natural flow vortex (a right-ventricular flow vortex) in right ventricle RV, which naturally re-directs blood entering right ventricle RV to pulmonary artery PA by direct flow without requiring right ventricle RV to perform substantial work of pumping blood.
  • Residual blood that is not transported to pulmonary artery PA via pulmonary valve PV by direct flow is pumped by the contraction of right ventricle RV.
  • the blood flows from pulmonary artery PA into smaller arteries that deliver the deoxygenated blood to the lungs via the pulmonary circulatory system. The lungs can then oxygenate the blood.
  • the left side of heart H including left atrium LA and left ventricle LV, receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows into left atrium LA from pulmonary veins PVS.
  • the offset of the right and left pulmonary veins PVS also leads to the formation of a natural flow vortex in left atrium LA (left-sided flow vortex), which helps maintain momentum and minimize work as the blood traverses left atrium LA to mitral valve MV.
  • Direct flow, as described above, and the pumping action of left atrium LA propels the blood through mitral valve MV into left ventricle LV.
  • a natural flow vortex (a left-ventricular flow vortex) forms in left ventricle LV, which redirects flow naturally towards the left ventricular outflow of aortic valve AV so that it can be efficiently pumped by left ventricle LV through aortic valve AV into aorta AT.
  • the blood flows from aorta AT into arteries that deliver the oxygenated blood to the body via the systemic circulatory system.
  • Blood is additionally received in right atrium RA from coronary sinus CS.
  • Coronary sinus CS collects deoxygenated blood from the heart muscle and delivers it to right atrium RA.
  • Thebesian valve BV (a pseudo-valve) is a semicircular fold of tissue at the opening of coronary sinus CS in right atrium RA.
  • Thebesian valve BV is not always present, but some studies show it is present in greater than sixty percent (60%) of hearts.
  • Coronary sinus CS is wrapped around heart H and runs in pail along and beneath the floor of left atrium LA right above mitral valve MV, as shown in FIG. 2.
  • Coronary sinus CS has an increasing diameter as it approaches right atrium RA.
  • Coronary sinus CS also wraps around a portion of right atrium RA posteriorly before in enters right atrium RA via the ostium of coronary sinus CS lateral and posterior to an orifice of tricuspid valve TV and medial to an inferior vena cava IVC entry point. Due to its proximity to inferior vena cava IVC, blood entering right atrium RA from coronary sinus CS is naturally entrained into the larger inflow from inferior vena cava IVC forming the natural flow vortex (right-sided flow vortex) in right atrium RA, which naturally redirects the inflows towards tricuspid valve TV.
  • Inter-atrial septum IS and fossa ovalis FO are also shown in FIG. 2.
  • Inter-atrial septum IS is the wall that separates right atrium RA from left atrium LA.
  • Fossa ovalis FO is a depression in inter-atrial septum IS in right atrium RA.
  • a congenital structure called a foramen ovale is positioned in inter-atrial septum IS.
  • the foramen ovale is an opening in interatrial septum IS that closes shortly after birth to form fossa ovalis FO.
  • the foramen ovale serves as a functional shunt in utero, allowing blood, primarily from inferior vena cava IVC and coronary sinus CS, to move from right atrium RA to left atrium LA to then be circulated through the body. This is necessary in utero, as the lungs are in a sack of fluid and do not oxygenate the blood. Rather, oxygenated blood is received from the mother.
  • the oxygenated blood from the mother flows from the placenta into inferior vena cava IVC through the umbilical vein and enters the inferior vena cava IVC via a natural shunt called the ductus venosus.
  • the oxygenated blood moves through inferior vena cava IVC to right atrium RA.
  • inferior vena cava IVC in right atrium RA is positioned to direct the oxygenated blood through right atrium RA and then through the foramen ovale (a second natural shunt) into left atrium LA along with the entrained deoxygenated blood from coronary sinus CS.
  • Left atrium LA can then pump the mixed oxygenated and deoxygenated blood into left ventricle LV, which pumps it to aorta AT and the systemic circulatory system. This allows the pulmonary circulatory system to be bypassed in utcro.
  • deoxygenated blood primarily from superior vena cava SVC
  • SVC superior vena cava SVC
  • ductus arteriosus a third natural shunt called the ductus arteriosus.
  • respiration expands the lungs, blood begins to circulate through the lungs to be oxygenated, and the three natural shunts close.
  • the closure of the foramen ovale forms fossa ovalis FO.
  • Shunts can be formed or positioned in heart H and/or vasculature V to shunt blood between anatomically adjacent chambers or vessels within the cardiovascular system.
  • shunts can be used to treat patients with heart failure. It has been hypothesized that both subgroups of heart failure (HFpEF and HFrEF) might benefit from a reduction in left atrial pressure (LAP), which in turn reduces the systolic preload on the left ventricle, left ventricular end diastolic pressure (LVEDP). Reducing LAP could also relieve back-pressure on the pulmonary circulation, reducing the risk of pulmonary edema, improving respiration, and improving patient comfort.
  • LAP left atrial pressure
  • LEDP left ventricular end diastolic pressure
  • the present disclosure provides methods and devices that may allow for elevated LAP to be reduced by shunting blood from a first anatomical chamber or vessel (e.g., left atrium LA) to a second anatomical chamber or vessel (e.g., coronary sinus CS).
  • a first anatomical chamber or vessel e.g., left atrium LA
  • a second anatomical chamber or vessel e.g., coronary sinus CS
  • Some examples involve a shunt defining an open pathway in a tissue wall between left atrium LA and coronary sinus CS, such as at a location where the two structures are in close approximation as coronary sinus CS passes through the atrio-ventricular groove that is covered by epicardium.
  • Left atrium to coronary sinus shunts move blood from left atrium LA into coronary sinus CS, which then delivers the blood to right atrium RA via the ostium of coronary sinus CS, the natural orifice of coronary sinus CS, which may have thebesian valve BV.
  • Coronary sinus CS is compliant and can quickly grow in response to increased volume with conditions such as drainage of the left subclavian vein to coronary sinus CS.
  • Shunting to coronary sinus CS offers some distinct advantages, primarily that coronary sinus CS is much less likely to have emboli present for several reasons.
  • the pressure gradient between coronary sinus CS and right atrium RA into which coronary sinus CS drains is very low, meaning that emboli in right atrium RA are likely to remain there.
  • interatrial septum IS can be preserved for later transseptal access for alternate therapies, and there could potentially be other therapeutic benefits to left atrium to coronary sinus shunting.
  • pressures in coronary sinus CS may increase by a small amount. This would cause blood in the coronary vasculature to travel more slowly through heart H, increasing perfusion and oxygen transfer, which would be more efficient, and which also could help a dying heart muscle to recover.
  • the preservation of transseptal access is also advantageous because heart failure patients often have a number of other comorbidities like atrial fibrillation (AF) and mitral regurgitation (MR), and several of the therapies for treating these conditions require a transseptal approach.
  • AF atrial fibrillation
  • MR mitral regurgitation
  • shunts can be formed or positioned in heart H to shunt blood between left atrium LA and right atrium RA.
  • Left atrium LA has a higher pressure and lower compliance compared to right atrium RA
  • right atrium RA has a lower pressure and higher compliance than left atrium LA.
  • Shunts can be used in patients with heart failure or other medical conditions to shunt blood from left atrium LA to right atrium RA to reduce LAP.
  • Septal shunts also called inter-atrial shunts or trans-septal shunts
  • septal shunts involve a shunt defining an open pathway in inter-atrial septum IS to shunt blood directly from left atrium LA to right atrium RA.
  • septal shunts are formed or positioned in fossa ovalis FO, as fossa ovalis FO is a thinner area of tissue in inter-atrial septum IS where the two atria share a common wall.
  • FIGS. 3A-15B Each electrocautery shunting device example shown in FIGS. 3A-15B includes several generally similar components, which share the same name and which are identified by shared reference numbers that are increased incrementally between each of FIGS. 3A-15B (e.g., FIGS. 3A-8 include electrocautery shunting device 100; FIGS. 9-10 include electrocautery shunting device 200; FIG. 11 includes electrocautery shunting device 300; FIG. 12 includes electrocautery shunting device 400; FIGS. 13A-13B include electrocautery shunting device 500; FIGS.
  • DEVICE 100 (FIGS. 3A-8)
  • FIG. 3A is a schematic cross-sectional side view of electrocautery shunting device 100 extending through opening TO in tissue wall TW.
  • FIG. 3B is a schematic cross-sectional front view of electrocautery shunting device 100 extending through opening TO in tissue wall TW taken at line 3B-3B of FIG. 3A and showing distal portion 109 of elongate tubular- body 101 surrounding electrocautery wire 106 and guidewire 108.
  • FIGS. 3A-3B will be discussed together.
  • electrocautery shunting device 100 (also referred to herein as “device 100”) includes elongate tubular body 101 (including exterior surface 102 and lumen 103), nosecone 104 (shown in FIG. 3A), electrocautery wire 106, and guidewire 108. Electrocautery wire 106 is connected to electrical source 105 (shown in FIG. 3A) via electrical connection 107 (shown in FIG. 3A). Elongate tubular body 101 further includes distal portion 109. As illustrated in FIG. 3A, electrocautery wire 106 includes attached end 110, and nosecone 104 includes wire attachment 112. FIGS. 3A-3B further show tissue wall TW and opening TO.
  • Electrocautery shunting device 100 is a catheter-based device for forming an implantless shunt (i.e., a shunt formed without implanting a device to maintain the shunt) through tissue wall TW.
  • Device 100 includes elongate tubular- body 101 and nosecone 104.
  • a proximal portion of device 100 (not shown) can include a handle or other similar component to be grasped by a physician or other user to control movement of device 100, which can further include a number of ports through which guidewires, tubes, fluids, or other components or elements may be passed.
  • Elongate tubular- body 101 is a length of catheter (a flexible shaft, tube, etc.) that can be moved through a patient’s heart and/or vasculature.
  • Elongate tubular body 101 is a main body portion of device 100.
  • Elongate tubular body 101 includes exterior surface 102 and lumen 103 extending therethrough.
  • Lumen 103 is defined by elongate tubular- body 101.
  • a capsule or outer sheath formed of a suitable flexible and durable material forms elongate tubular body 101.
  • Lumen 103 is a longitudinal opening or passage that extends axially through elongate tubular body 101.
  • Lumen 103 contains electrocautery wire 106 and guidewire 108 and may also contain any other wires, tubes, fluids, or other components or elements of device 100.
  • elongate tubular- body 101 may include one or more lumens.
  • Guidewire 108 extends longitudinally through elongate tubular body 101 and nosecone 104. Guidewire 108 extends within lumen 103 in elongate tubular body 101.
  • Electrocautery wire 106 also extends longitudinally through elongate tubular body
  • electrocautery wire 106 is a metal wire. In some examples, electrocautery wire 106 is a coated wire. In some examples, electrocautery wire 106 is visible with fluoroscopy. Electrocautery wire 106 is configured to conduct an electrical current (also referred to herein as energized electrocautery wire 106, compared to an unenergized state where electrocautery wire 106 is not receiving electrical current) and generate heat as the electrical current is passed therethrough such that tissue contacted by the heated wire is immediately sealed. Electrocautery wire 106 is connected to electrical source 105 via electrical connection 107 (indicated with dashed lines in FIG. 3A).
  • Electrical source 105 is any suitable electrical source for supplying the electrical current to electrocautery wire 106.
  • electrical source 105 can be positioned externally to a patient’s body during a shunt formation procedure.
  • Electrical connection 107 can be a wired connection between electrical source 105 and electrocautery wire 106. In one example, a portion of electrical connection 107 can pass into device 100, such as at a handle portion of device 100, to connect between electrical source 105 and electrocautery wire 106.
  • Electrocautery wire 106 is also rotatable. More specifically, electrocautery wire 106 is able to rotate circumferentially about a central longitudinal axis of device 100 that is generally represented in FIG. 3A by guidewire 108. In some examples, electrocautery wire 106 is moveable within lumen 103 to rotate independently of other components of device 100. In other examples, electrocautery wire 106 is rotatable with elongate tubular body 101 or another portion of device 100. In yet other examples, electrocautery wire 106 is rotatable with a whole of device 100. For example, a proximal end (not shown) of electrocautery wire 106, such as at a handle portion, can be rotated manually by a physician.
  • clcctrocautcry wire 106 is connected to nosecone 104 at attached end 110. Accordingly, electrocautery wire 106 can be considered an attached electrocautery wire. Attached end 110 forms a distal end of electrocautery wire 106. Attached end 110 is affixed to nosecone 104 at wire attachment 112. Wire attachment 112 can include any suitable attachment mechanism, such as, e.g., a clip, a loop, a mating connector, an adhesive, etc., for securing attached end 110 of electrocautery wire 106 to nosecone 104.
  • wire attachment 112 is within an interior of nosecone 104, which can help reduce any risk of electrocautery wire 106 becoming disrupted or dislodged during use. Moreover, wire attachment 112 is configured to remain connected to electrocautery wire 106 when electrocautery wire 106 is tensioned, as will be described in greater detail below with reference to FIG. 5. Attached end 110 being affixed to wire attachment 112 can allow electrocautery wire 106 to have sufficient stiffness to rotate through tissue wall TW, as will be described in greater detail below.
  • Device 100 can be introduced to a target site (e.g., along tissue wall TW) within a chamber or vessel of a patient’s cardiovascular system using any suitable catheterization techniques.
  • a target site e.g., along tissue wall TW
  • FIGS. 1-2 Reference will be made to reference characters shown in FIGS. 1-2 in the following discussion.
  • Several access pathways for maneuvering guidewires and catheters in and around heart H can be seen from the anatomy in FIGS. 1-2.
  • access may be from above (superior access) via either the subclavian vein or jugular vein into superior vena cava SVC, through right atrium RA, and from there into coronary sinus CS through its ostium.
  • an access path may stall in the femoral vein (inferior access) and proceed through inferior vena cava IVC into heart H.
  • Other access routes may also be used, and each typically utilizes a percutaneous incision through which a guidewire and catheter are inserted into vasculature V, normally through a sealed introducer. A physician typically controls the distal ends of the devices from outside the body.
  • tissue wall TW is any tissue wall between anatomically adjacent chambers or vessels of the cardiovascular system of a patient.
  • tissue wall TW is between anatomically adjacent chambers or vessels where there is a pressure gradient from a relatively higher-pressure chamber or vessel on one side of tissue wall TW to a relatively lower-pressure chamber or vessel on the opposing side of tissue wall TW.
  • tissue wall TW can be the tissue wall between left atrium LA (relatively higher pressure) and coronary sinus CS (relatively lower pressure).
  • tissue wall TW can be inter-atrial septum IS between left atrium LA (relatively higher pressure) and right atrium RA (relatively lower pressure).
  • Tissue wall TW can include multiple layers of tissue.
  • Opening TO can be formed in tissue wall TW.
  • opening TO may have a generally circular shape.
  • Opening TO can be created using one or more of a guidewire, puncture catheter, introducer sheath, puncture sheath, and/or puncture expander. Opening TO may create an initial blood flow path between two anatomical chambers or vessels (e.g., left atrium LA and coronary sinus CS). Opening TO can be created in any of a variety of ways.
  • a guidewire can be inserted into vasculature V and advanced to the desired location along tissue wall TW using the techniques described above.
  • the site selected for shunt formation may be an area where the tissue of the patient is less thick or less dense, e.g., as determined beforehand by non-invasive diagnostic means, such as a CT scan or radiographic techniques, such as fluoroscopy or intravascular ultrasound (IVUS) or intravascular echocardiography.
  • non-invasive diagnostic means such as a CT scan or radiographic techniques, such as fluoroscopy or intravascular ultrasound (IVUS) or intravascular echocardiography.
  • a catheter may be advanced over the guidewire.
  • the catheter may be introduced into the body through a proximal end of an introducer sheath.
  • An introducer sheath may provide access to vasculature V and may have a hemostatic valve therein to prevent blood loss.
  • a physician can manipulate a puncture catheter to the desired shunt formation site.
  • a puncture sheath having a puncture needle with a sharp tip may be advanced along the catheter and punctured through tissue wall TW into, for example, left atrium LA, to form opening TO.
  • a puncture expander may be advanced along the guidewire and through opening TO.
  • the puncture expander may be, for example, an elongated inflatable balloon.
  • the puncture expander may be inflated radially outward to widen opening TO.
  • a separate puncture catheter may be used to puncture tissue wall TW at the desired location to form opening TO before device 100 is moved to opening TO.
  • device 100 may include both puncture preparation and shunt formation functionality.
  • guidewire 108 is passed through opening TO once opening TO has been formed in tissue wall TW.
  • Opening TO can be sized or, in some examples, dilated to a size sufficient for nosecone 104 of device 100 to pass through.
  • Device 100 is then moved distally along guidewire 108 until nosecone 104 is advanced through opening TO.
  • Distal portion 109 of elongate tubular body 101 is also advanced through opening TO such that electrocautery wire 106 crosses tissue wall TW, as illustrated in FIGS. 3A-3B.
  • FIG. 4A is a schematic cross-sectional side view of electrocautery shunting device
  • FIG. 4B is a schematic cross-sectional front view of electrocautery shunting device 100 extending through opening TO in tissue wall TW taken at line 4B-4B of FIG. 4A and showing tissue wall TW closed against electrocautery wire 106 and guidewire 108.
  • FIG. 5 is a schematic cross-sectional front view of electrocautery shunting device 100 extending through opening TO in tissue wall TW and showing radial cut RC. FIGS. 4A-5 will be discussed together.
  • FIG. 4A shows electrocautery shunting device 100, including elongate tubular body
  • Device 100 further includes electrocautery wire 106 (including attached end 110 (shown in FIG. 4A)) and guidewire 108.
  • FIG. 4A further shows exposed portion 114 of electrocautery wire 106, electrocautery wire contact surface 116, guidewire contact surface 118, and retraction direction A.
  • FIGS. 4A-5 further show tissue wall TW and opening TO.
  • FIG. 5 further shows radial cut RC.
  • Elongate tubular body 101 holds opening TO in tissue wall TW open.
  • Elongate tubular body 101 can be retracted in retraction direction A, as indicated by the arrows in FIG. 4A. Retraction of elongate tubular body 101 in retraction direction A withdraws distal portion 109 proximally and exposes electrocautery wire 106 and guidewire 108.
  • Elongate tubular body 101 can also be advanced after retraction to cover electrocautery wire 106 and guidewire 108, and to bring nosecone 104 back into contact with elongate tubular body 101 for withdrawing device 100.
  • Exposed portion 114 of electrocautery wire 106 is the portion of electrocautery wire 106 that is exposed by retraction of elongate tubular body 101. Exposed portion 114 crosses through opening TO. Tissue wall TW will resiliently close (i.e., opening TO will shrink) against exposed portion 114 of electrocautery wire 106 and guidewire 108, as shown in FIGS. 4A-4B.
  • electrocautery wire contact surface 116 is a region along exposed portion 114 of electrocautery wire 106 that contacts tissue wall TW within opening TO after tissue wall TW has closed against clcctrocautcry wire 106.
  • guidewire contact surface 118 is a region of guidewire 108 that contacts tissue wall TW within opening TO after tissue wall TW has closed against guidewire 108.
  • Electrocautery wire 106 is movable between a relaxed state and a tensioned state.
  • FIG. 4B shows electrocautery wire 106 in a relaxed state. In the relaxed state, electrocautery wire 106 and guidewire 108 rest against tissue wall TW within opening TO. Electrocautery wire 106 can also be unenergized in the configuration shown in FIG. 4B.
  • FIG. 5 shows electrocautery wire 106 in a tensioned state. Electrocautery wire 106 can be tensioned by tightening, such as by physician action at a handle portion of device 100 external to the body. Electrocautery wire 106 is also energized as described previously to cut through tissue wall TW.
  • Tensioning and energizing electrocautery wire 106 causes electrocautery wire 106 to create radial cut RC in tissue wall TW, as shown in FIG. 5.
  • Radial cut RC extends radially outward from opening TO and can generally be any desired length. The length of radial cut RC can depend on the radial position of electrocautery wire 106 in its tensioned state. In some examples, the position of electrocautery wire 106 in its tensioned state can be configurable within device 100 to create radial cut RC with a desired length.
  • FIG. 6A is a schematic cross-sectional side view of electrocautery shunting device 100 extending through opening TO in tissue wall TW and showing partial rotation of electrocautery shunting device 100.
  • FIG. 6B is a schematic cross-sectional front view of electrocautery shunting device 100 extending through opening TO in tissue wall TW taken at line 6B-6B of FIG. 6A and showing partial circumferential cut CC1.
  • FIG. 6C is a schematic top-down view of shunt S with tissue flap TF cut via the partial rotation of electrocautery shunting device
  • FIGS. 6A-6C will be discussed together.
  • FIG. 6A shows electrocautery shunting device 100, including elongate tubular body
  • Device 100 further includes electrocautery wire 106 (shown in FIGS. 6A-6B) (including attached end 110 (shown in FIG. 6A) and exposed portion 114 (shown in FIG. 6A)) and guidewire 108 (shown in FIGS. 6A-6B).
  • FIGS. 6A-6C further show tissue wall TW.
  • FIG. 6A further shows partial rotation direction B.
  • FIG. 6B further shows radial cut RC and partial circumferential cut CC1.
  • FIGS. 6B-6C further show tissue flap TF.
  • FIG. 6C shows shunt S.
  • electrocautery wire 106 is rotatable about a central longitudinal axis of device 100 that is generally represented by guidewire 108, either independently within lumen 103 or with other components, portions, or a whole of device 100.
  • electrocautery wire 106 can be maintained in (or resume) its tensioned and energized state and can be rotated to further cut through tissue wall TW.
  • electrocautery wire 106 completes a partial circumferential rotation in partial rotation direction B, as shown in FIG. 6A.
  • FIG. 6A shows the positioning of device 100 and electrocautery wire 106 after a partial circumferential rotation has been completed.
  • partial rotation direction B shown in FIG. 6A is arbitrary, and partial rotation direction B could also be clockwise in other examples.
  • the partial circumferential rotation of electrocautery wire 106 in partial rotation direction B creates partial circumferential cut CC1, as shown in FIG. 6B.
  • partial circumferential cut CC1 is an arc-shaped cut through tissue wall TW. More specifically, partial circumferential cut CC1 is an arc that is less than 360 degrees. In one non-limiting example, partial circumferential cut CC1 can be an arc that is about 180 degrees.
  • electrocautery wire 106 can be rotated a relatively small amount to form an initial partial circumferential cut CC1 and then continue rotating to increase the length of partial circumferential cut CC1, for instance, if real-time monitoring indicates that a greater shunting effect would be beneficial.
  • Partial circumferential cut CC1 forms shunt S.
  • Shunt S is a patent opening through tissue wall TW.
  • shunt S has an edge that is defined by partial circumferential cut CC1.
  • tissue flap TF remains attached to and continuous with the rest of tissue wall TW.
  • tissue flap TF may be generally “C”-shaped, depending on the arc length of partial circumferential cut CC 1 , and the corresponding shunt S may be generally shaped like a half circle.
  • Tissue flap TF can flexibly cover shunt S, as shown top-down in FIG. 6C.
  • tissue flap TF may be pushed open and folded to the side with blood flow through shunt S, such as when a pressure gradient exists between the chambers or vessels on either side of tissue wall TW.
  • Electrocautery wire 106 can also fuse or seal tissue wall TW when it forms shunt S. After formation of shunt S, device 100 can be retracted through shunt S and removed from the body.
  • FIG. 7A is a schematic cross-sectional side view of electrocautery shunting device 100 extending through opening TO in tissue wall TW and showing full rotation of clcctrocautcry shunting device 100.
  • FIG. 7A is a schematic cross-sectional side view of electrocautery shunting device 100 extending through opening TO in tissue wall TW and showing full rotation of clcctrocautcry shunting device 100.
  • FIG. 7B is a schematic cross-sectional front view of electrocautery shunting device 100 extending through opening TO in tissue wall TW taken at line 7B-7B of FIG. 7A and showing full circumferential cut CC2.
  • FIG. 7C is a schematic cross-sectional side view of electrocautery shunting device 100 showing shunt S cut via the full rotation of electrocautery shunting device 100 shown in FIG. 7A.
  • FIG. 8 is a schematic front view of tissue segment TS cut using attached electrocautery wire 106. FIGS. 7A-8 will be discussed together.
  • FIGS. 7 A and 7C show electrocautery shunting device 100, including elongate tubular body 101 (including exterior surface 102 and lumen 103) and nosecone 104 (including wire attachment 112).
  • Device 100 further includes electrocautery wire 106 (shown in FIGS. 7A- 7C) (including attached end 110 (shown in FIGS. 7A and 7C) and exposed portion 114 (shown in FIGS. 7A and 7C)), and guidewire 108 (shown in FIGS. 7A-7C).
  • FIGS. 7A-7C further show tissue wall TW.
  • FIG. 7A further shows full rotation direction C.
  • FIG. 7B further shows full circumferential cut CC2 and diameter D.
  • FIGS. 7B and 8 show radial cut RC and cut tissue segment TS.
  • FIG. 7C further shows shunt S.
  • FIG. 8 further shows separated ends SE.
  • tensioned and energized electrocautery wire 106 can instead complete a full circumferential rotation in full rotation direction C, as shown in FIG. 7A.
  • full rotation direction C As with partial rotation direction B (shown in FIG. 6A), it should be understood that the counterclockwise orientation of full rotation direction C shown in FIG. 7A is arbitrary, and full rotation direction C could also be clockwise in other examples.
  • the full circumferential rotation of electrocautery wire 106 in full rotation direction C creates full circumferential cut CC2, as shown in FIG. 7B.
  • Full circumferential cut CC2 is effectively a continuation of partial circumferential cut CC1 shown in FIG. 6B.
  • partial circumferential cut CC1 (shown in FIG. 6B) may be created initially and then extended to create full circumferential cut CC2, for instance, if real-time monitoring indicates that a greater shunting effect would be beneficial.
  • full circumferential cut CC2 Due to the full rotation of electrocautery wire 106, full circumferential cut CC2 is a generally circular cut through tissue wall TW. That is, full circumferential cut CC2 is a 360-degree cut, whereas partial circumferential cut CC1 (shown in FIG. 6B) is a less than 360-degree arc.
  • full circumferential cut CC2 can also form shunt S, which is a patent opening through tissue wall TW.
  • shunt S has an edge that is defined by full circumferential cut CC2.
  • electrocautery wire 106 completes a full circumferential rotation and creates full circumferential cut CC2 (rather than partial circumferential cut CC1, as shown in FIG. 6B) in this example, cut tissue segment TS is separated from tissue wall TW.
  • cut tissue segment TS is a split ring of excised tissue with a split corresponding to radial cut RC.
  • the corresponding shunt S may be generally circular or round.
  • cut tissue segment TS is fully detached from tissue wall TW.
  • Cut tissue segment TS has separated ends SE on either side of radial cut RC.
  • cut tissue segment TS can be captured on device 100 and removed from the body (e.g., with suction, etc.) or otherwise discarded.
  • elongate tubular body 101 and nosecone 104 are approximated towards each other in a manner that sandwiches and traps cut tissue segment TS therebetween, such that retrieval of device 100 will remove cut tissue segment TS from the patient’s body.
  • Full circumferential cut CC2 has diameter D.
  • Diameter D defines a width of the resulting shunt S.
  • Diameter D is generally controlled by the size (length) of radial cut RC.
  • a longer radial cut RC increases diameter D (and a shorter radial cut RC decreases diameter D).
  • radial cut RC can generally be any length.
  • Radial cut RC can, in some examples, be selected based on a desired diameter D, which, in turn, can be selected based on a desired level of blood flow through the resulting shunt S. Accordingly, the level of shunted blood flow can be modulated based on diameter D.
  • diameter D can be less than ten millimeters ( ⁇ 10 mm). In another non-limiting example, diameter D can be between 4 and 10 millimeters (4-10 mm). In another example, diameter D can be between five and eight millimeters (5-8 mm). Electrocautery wire 106 can also fuse or seal tissue wall TW when it forms shunt S. After formation of shunt S, device 100 can be retracted through shunt S and removed from the body.
  • device 100 creates an implantless shunt between anatomically adjacent chambers or vessels of the cardiovascular system of a patient, such as between left atrium LA and coronary sinus CS (shown in FIG. 2), to shunt blood from a relatively higher-pressure chamber or vessel into a relatively lower-pressure chamber or vessel.
  • device 100 can create an implantless shunt to mitigate elevated LAP, such as in patients experiencing heart failure or other medical conditions.
  • an implantless shunt formation procedure carried out using device 100 can be a relatively short intervention, thereby reducing patient risk posed by more extensive procedures. Additionally, device 100 can improve patient outcomes because an opening through tissue created using electrocautery wire 106 has a higher likelihood of remaining patent (i.e., being permanent) than traditional shunts created with mechanical cutting techniques or by using a stent in a dilated opening, which have some potential to reclose. That is, tissue ingrowth that could cause a shunt to reclose can be minimized or prevented by using energized electrocautery wire 106 to create shunt S with a sealed or cauterized edge. In turn, the higher likelihood of creating a permanent shunt with device 100 can correspond to decreased frequency of further interventions, such as to reopen a closed shunt.
  • Patient outcomes can also be improved because the size of the implantless shunt is controllable with device 100.
  • the length of the cut to form shunt S can be selected or adjusted (either a partial or full circumferential cut) based on patient- specific requirements and/or patient parameters determined during a shunting procedure. This presents an advantage over one-size-fits-all type implantable shunt devices that are either deployed and functioning properly or not, with no adjustments possible.
  • Another advantage of using device 100 is that no stent or similar device is implanted in the body to form or maintain a shunt opening.
  • a shunt formation procedure using device 100 may not leave any implanted devices behind in the body at all. Forming an implantless shunt can reduce the complexity of the shunt formation procedure and further reduce the risk for the patient.
  • tissue wall TW can include multiple layers of tissue.
  • the edges of adjacent tissue layers at shunt S can be welded together on contact with electrocautery wire 106, thereby fusing the adjacent tissue layers and preventing fluid from seeping through the shunt wall and between adjacent tissue layers.
  • FIG. 9 is a schematic cross-sectional side view of electrocautery shunting device 200 extending through opening TO in tissue wall TW and including proximally tapered nosecone 204 and unattached electrocautery wire 206.
  • FIG. 10 is a schematic front view of tissue ring TR cut using unattached clcctrocautcry wire 206 of FIG. 9. FIGS. 9-10 will be discussed together.
  • electrocautery wire 206 is unattached to nosecone 204 and is instead provided with free end 220. Accordingly, electrocautery wire 206 can be considered an unattached electrocautery wire. Free end 220 forms a distal end of electrocautery wire 206. Free end 220 is not affixed to nosecone 204, so electrocautery wire 206 can be moved longitudinally within device 200 and separately from nosecone 204. Nosecone 204 includes wire receiver 222.
  • Wire receiver 222 can be a slot or tunnel or other appropriately sized space on nosecone 204 that is configured to receive and secure free end 220 of electrocautery wire 206.
  • wire receiver 222 can be sized such that free end 220 is able to be slidably received in wire receiver 222 but radial movement of free end 220 is minimized or prevented.
  • wire receiver 222 is within an interior of nosecone 204, which can help reduce any risk of electrocautery wire 206 becoming disrupted or dislodged during use.
  • Nosecone 204 also includes proximal tapered portion 224.
  • Proximal tapered portion 224 encompasses a rear or proximal end of nosecone 204.
  • Proximal tapered portion 224 is shaped such that the proximal end of nosecone 204 is frustoconical and tapered proximally (or with the narrowest portion facing toward elongate tubular body 201).
  • Proximal tapered portion 224 facilitates proximal retraction of nosecone 204, such as during removal of device 200 from the body. Compared to a sharper edge, proximal tapered portion 224 can more easily pass back through a smaller opening without disrupting the tissue, as nosecone 204 is retracted.
  • electrocautery wire 206 can be visualized with fluoroscopy so that a physician can monitor the progress of electrocautery wire 206 in real time as it is advanced to tissue wall TW.
  • a physician may also be able to manually appreciate resistance when electrocautery wire 206 contacts tissue wall TW.
  • electrocautery wire 206 Upon reaching tissue wall TW, electrocautery wire 206 can be pushed to pierce or puncture through tissue wall TW from first side TW 1 to second side TW2. Electrocautery wire 206 has sufficient axial strength such that when pushed distally, it can penetrate tissue wall TW. In some examples, electrocautery wire 206 can be energized (i.e., electrical current can be supplied to electrocautery wire 206) to facilitate crossing of tissue wall TW. Pushing through tissue wall TW can position electrocautery wire 206 at a radial distance within tissue wall TW similar to the position of electrocautery wire 106 after forming radial cut RC, as shown in FIG. 5, without requiring formation of a radial cut.
  • electrocautery wire 206 After crossing tissue wall TW, free end 220 of electrocautery wire 206 can be secured in wire receiver 222. Securing free end 220 in wire receiver 222 can allow electrocautery wire 206 to have sufficient stiffness to rotate through tissue wall TW. [0139] Once electrocautery wire 206 is pushed through tissue wall TW and secured in wire receiver 222, clcctrocautcry wire 206 can be rotated as previously described, cither to form a partial circumferential cut (as described with reference to FIGS. 6A-6C) or a full circumferential cut (as described with reference to FIGS. 7A-8). In examples where electrocautery wire 206 forms a full circumferential cut, cut tissue ring TR is separated from tissue wall TW.
  • cut tissue ring TR is a closed circle or ring of excised tissue. Because cut tissue ring TR does not have separated ends, cut tissue ring TR can be captured around guidewire 208, which extends therethrough. In some examples, elongate tubular' body 201 and nosecone 204 are approximated towards each other in a manner that sandwiches and traps cut tissue ring TR therebetween, such that retrieval of device 200 will remove cut tissue ring TR from the patient’s body. Accordingly, tissue ring TR can be more easily retrieved, with reduced risk of embolization.
  • FIG. 11 is a schematic cross-sectional front view of electrocautery shunting device 300 extending through opening TO in tissue wall TW and showing integrated sensor 326.
  • electrocautery shunting device 300 (also referred to herein as “device 300”) includes elongate tubular body 301 (including exterior surface 302 and lumen 303), nosecone 304, electrocautery wire 306, and guidewire 308.
  • Device 300 further includes integrated sensors 326A- 326B (referred to collectively and individually herein as sensor(s) 326).
  • FIG. 11 further shows tissue wall TW, including first side TW 1 and second side TW2.
  • Device 300 has a generally similar structure and design to device 100 described above in reference to FIGS. 3A-8, except device 300 includes integrated sensors 326. Details of similar features or components will not be repeated in this section, except to the extent there are any differences. Integrated sensors 326 are described here with respect to device 300 but can also be included in any of the examples of an electrocautery shunting device described herewith, including devices 100, 200, 400, 500, 600, and 700, or in combination shunting system 900.
  • Integrated sensors 326 are connected to device 300.
  • one or more integrated sensors 326 are integrated with an exterior surface of device 300.
  • one or more integrated sensors 326 are contained within device 300.
  • device 300 includes two integrated sensors 326.
  • device 300 can include any number of integrated sensors 326, such as more or fewer than two integrated sensors 326.
  • integrated sensor 326A is configured to be positioned within a first chamber or vessel on first side TW1 of tissue wall TW. Accordingly, integrated sensor 326A can be connected to or contained within elongate tubular body 301.
  • Integrated sensor 326B is configured to be positioned within a second chamber or vessel on second side TW2 of tissue wall TW.
  • integrated sensor 326B can be connected to or contained within nosecone 304. Although a single integrated sensor 326A and a single integrated sensor 326B are illustrated in FIG. 11 for simplicity, it should be appreciated that any number of integrated sensors 326 can be connected to or contained within elongate tubular body 101 and/or nosecone 304. Moreover, some examples may include either integrated sensor 326 A or integrated sensor 326B.
  • Integrated sensors 326 allow for real-time monitoring of patient parameters, such as pressure, during a shunt formation procedure. Based on signals from integrated sensors 326, a physician can determine whether a desired shunting effect, such as a desired reduction in pressure, has been achieved. For example, a physician can monitor changes in pressure as tissue is being cut to determine appropriate shunt dimensions (e.g., a length of a partial circumferential cut, selecting a partial or full circumferential cut, etc.). This allows the shunt formation procedure using device 300 to be tailored to patient- specific requirements.
  • FIG. 12 is a schematic cross-sectional front view of electrocautery shunting device 400 extending through opening TO in tissue wall TW and showing independent sensor 428.
  • electrocautery shunting device 400 also referred to herein as “device 400” includes elongate tubular body 401 (including exterior surface 402 and lumen 403), nosecone 404, electrocautery wire 406, and guidewire 408.
  • FIG. 12 further shows independent sensors 428A- 428B and corresponding sensor anchors 429A-429B (referred to collectively and individually herein as sensor(s) 428 and sensor anchor(s) 429, respectively).
  • FIG. 12 further shows tissue wall TW, including first side TW 1 and second side TW2.
  • Device 400 has a generally similar structure and design to device 100 described above in reference to FIGS. 3A-8, except device 400 is used with independent sensors 428. Details of similar features or components will not be repeated in this section, except to the extent there are any differences. Independent sensors 428 and related components are described here with respect to device 400 but can also be included with any of the examples of an electrocautery shunting device described herewith, including devices 100, 200, 300, 500, 600, and 700, or in combination shunting system 900.
  • Device 400 can be used with one or more independent sensors 428.
  • independent sensors 428 can be pressure sensors to sense (or measure) a pressure in a chamber or vessel of the cardiovascular system.
  • independent sensors 428 can be any sensor or sensors to measure a parameter in a chamber or vessel of the cardiovascular system.
  • each independent sensor 428 can include a transducer, control circuitry, and an antenna.
  • the transducer for example a pressure transducer, is configured to sense a signal from the chamber or vessel of the cardiovascular system.
  • the transducer can communicate the signal to the control circuitry.
  • the control circuitry can process the signal from the transducer or communicate the signal from the transducer to a remote device outside of the body using the antenna.
  • Each independent sensor 428 can include alternate or additional components in other examples. Further, the components of independent sensors 428 can be held in a sensor housing that is hermetically sealed. In some examples, an electrocautery shunting device according to techniques of this disclosure could utilize a combination of integrated sensors (e.g., integrated sensors 326, as shown in FIG. 11) and independent sensors (e.g., independent sensors 428, as shown in FIG. 12).
  • integrated sensors e.g., integrated sensors 326, as shown in FIG. 11
  • independent sensors e.g., independent sensors 428, as shown in FIG. 12
  • independent sensors 428 are not directly connected to device 400. Instead, each of independent sensors 428 may include a corresponding sensor anchor 429. That is, independent sensor 428A may include sensor anchor 429A, and independent sensor 428B may include sensor anchor 429B .
  • Sensor anchors 429 can be any suitable mechanism for anchoring or supporting independent sensors 428, e.g., within a chamber or vessel or to tissue wall TW.
  • the anchor mechanism can be a coil of wire. The coiled wire can suspend the corresponding independent sensor 428A within a chamber or vessel, such as in a position close to device 400.
  • the anchor mechanism can be a hook, clip, suture, or the like for attaching the corresponding independent sensor 428B to tissue wall TW.
  • Independent sensor 428B can be connected to tissue wall TW by sensor anchor 429B in a position close to device 400 on either side of tissue wall TW.
  • independent sensors 428 can be positioned proximal to, distal to, and/or adjacent to device 400 within the cardiovascular system of the patient during a shunt formation procedure for the patient.
  • Independent sensor(s) 428 may be positioned on the second side TW2 of tissue wall TW, which is opposite the first side TW1.
  • Sensor 428 may be on the side TW2 that is opposite with respect to the tissue wall TW from the position of the elongate tubular body 402, as depicted in Fig. 12.
  • the example shown in FIG. 12 includes two independent sensors 428. In other examples, any number of independent sensors 428 can be used, such as more or fewer than two independent sensors 428.
  • independent sensor 428 A is configured to be positioned within a first chamber or vessel on first side TW 1 of tissue wall TW.
  • independent sensor 428A is connected to first side TW1 of tissue wall TW by sensor anchor 429A.
  • independent sensor 428 A is suspended in the first chamber or vessel on first side TW 1 by sensor anchor 429A.
  • Independent sensor 428B is configured to be positioned within a second chamber or vessel on second side TW2 of tissue wall TW.
  • independent sensor 428B is connected to second side TW2 of tissue wall TW by sensor anchor 429B. In other examples, independent sensor 428B is suspended in the second chamber or vessel on second side TW2 by sensor anchor 429B. Although a single independent sensor 428 A and a single independent sensor 428B are illustrated in FIG. 12 for simplicity, it should be appreciated that any number of independent sensors 428 can be associated with device 400. Moreover, some examples may include either independent sensor 428 A or independent sensor 428B.
  • independent sensors 428 allow for real-time monitoring of patient parameters, such as pressure, during a shunt formation procedure. Based on signals from independent sensors 428, a physician can determine whether a desired shunting effect, such as a desired reduction in pressure, has been achieved. For example, a physician can monitor changes in pressure as tissue is being cut to determine appropriate shunt dimensions (e.g., a length of a partial circumferenti l cut, selecting a partial or full circumferential cut, etc.). This allows the shunt formation procedure using device 400 to be tailored to patient- specific requirements. Independent sensors 428 can also be configured to remain in a respective chamber or vessel after device 400 is removed from the body, thereby permitting post-procedure monitoring of the implantless shunt.
  • a desired shunting effect such as a desired reduction in pressure
  • DEVICE 500 (FIGS. 13A-13B)
  • FIG. 13A is a schematic cross-sectional side view of electrocautery shunting device 500 extending through opening TO in tissue wall TW and including multi-lumen shaft 530.
  • FIG. 13B is a schematic cross-sectional front view of electrocautery shunting device 500 taken at line 13B-13B of FIG. 13A showing electrocautery wire 506 in electrocautery wire lumen 532 and guidewire 508 in guidewire lumen 534 of multi-lumen shaft 530.
  • FIGS. 13A-13B will be discussed together.
  • electrocautery shunting device 500 (also referred to herein as “device 500”) includes elongate tubular body 501 and nosecone 504. Device 500 further includes electrocautery wire 506 and guidewire 508. Elongate tubular body 501 includes multilumen shaft 530.
  • FIG. 13B shows electrocautery wire lumen 532 and guidewire lumen 534 of multi-lumen shaft 530.
  • FIG. 13A further shows tissue wall TW.
  • Device 500 has a generally similar structure and design to device 100 described above in reference to FIGS. 3A-8, except device 500 includes multi-lumen shaft 530 (including electrocautery wire lumen 532 and guidewire lumen 534). Details of similar features or components will not be repeated in this section, except to the extent there are any differences. Multi-lumen shaft 530, including electrocautery wire lumen 532 and guidewire lumen 534, is described here with respect to device 500 but can also be included in any of the examples of an electrocautery shunting device described herewith, including devices 100, 200, 300, 400, 600, and 700, or in combination shunting system 900.
  • Multi-lumen shaft 530 is an elongated shaft including multiple lumens. Multilumen shaft 530 can be relatively flexible for navigating chambers and vessels of the cardiovascular system. In some examples, multi-lumen shaft 530 is surrounded by a capsule or outer sheath, as illustrated in FIG. 13 A. However, a capsule or outer sheath is optional, and, in other examples, multi-lumen shaft 530 makes up an entirety of elongate tubular body 501. Multi- lumen shaft 530 can be retracted to expose electrocautery wire 506 and guidewire 508 in the manner described previously with respect to elongate tubular body 101 in FIG. 4A.
  • Multi-lumen shaft 530 includes electrocautery wire lumen 532 and guidewire lumen 534. Electrocautery wire lumen 532 and guidewire lumen 534 are longitudinal lumens that extend through multi-lumen shaft 530. Electrocautery wire 506 extends longitudinally through electrocautery wire lumen 532, and guidewire 508 extends longitudinally through guidewire lumen 534. As illustrated in FIG. 13B, guidewire lumen 534 may be located approximately centrally within multi-lumen shaft 530. Electrocautery wire lumen 532, on the other hand, may be located at a radial distance away from guidewire lumen 534 within multi-lumen shaft 530.
  • multi-lumen shaft 530 prevent unwanted interactions between electrocautery wire 506 and guidewire 508 within elongate tubular body 501.
  • multi-lumen shaft 530 can provide additional support to electrocautery wire 506 via electrocautery wire lumen 532.
  • multi-lumen shaft 530 can allow for easier torquing of electrocautery wire 506 to create a circumferential cut.
  • the separate and radially-offset lumens of multi-lumen shaft 530 i.e., electrocautery wire lumen 532 and guidewire lumen 534), enable rotation of electrocautery wire 506 and, via the link of electrocautery wire 506 to nosecone 504, rotation of nosecone 504 that is responsive to rotation of multi-lumen shaft 530.
  • DEVICE 600 (FIGS. 14A-14B)
  • FIG. 14A is a schematic cross-sectional side view of electrocautery shunting device
  • FIG. 14B is a schematic cross-sectional front view of electrocautery shunting device 600 taken at line 14B-14B of FIG. 14A showing electrocautery wires 606 in electrocautery wire lumens 632 and guidewire 608 in guidewire lumen 634 of multilumen shaft 630.
  • FIGS. 14A-I4B will be discussed together.
  • electrocautery shunting device 600 (also referred to herein as “device 600”) includes elongate tubular- body 601 and nosecone 604. Device 600 further includes electrocautery wires 606 and guidewire 608. Elongate tubular body 601 includes multilumen shaft 630. FIG. 14B shows electrocautery wire lumens 632 and guidewire lumen 634 of multi-lumen shaft 630. FIG. 14A further shows tissue wall TW. [0163] Device 600 has a generally similar structure and design to device 500 described above in reference to FIGS. 13A-13B, except device 600 includes multiple clcctrocautcry wires 606 and multiple electrocautery wire lumens 632.
  • Electrocautery wires 606 and electrocautery wire lumens 632 are described here with respect to device 600 but can also be included in any of the examples of an electrocautery shunting device described herewith, including devices 100, 200, 300, 400, 500, and 700, or in combination shunting system 900.
  • device 600 includes multiple (i.e., at least two) electrocautery wires 606. Although the example shown in FIGS. 14A-14B includes two electrocautery wires 606, other examples can include more than two electrocautery wires 606, such as three, four, six, eight, or other totals.
  • Multi-lumen shaft 630 likewise includes multiple electrocautery wire lumens 632. Electrocautery wire lumens 632 are longitudinal lumens that extend through multi-lumen shaft 630.
  • Each individual one of electrocautery wires 606 extends through a corresponding one of clcctrocautcry wire lumens 632, such that the number of electrocautery wire lumens 632 equals the number of electrocautery wires 606.
  • Any one or more (or all) of electrocautery wires 606 can have the characteristics of attached electrocautery wire 106 (shown in FIG. 3A) or unattached electrocautery wire 206 (shown in FIG. 9), as described previously. Additionally, some examples can include a combination of attached and unattached electrocautery wires.
  • Electrocautery wires 606 (and corresponding electrocautery wire lumens 632) are spaced circumferentially about multi-lumen shaft 630. In some examples, electrocautery wires 606 are evenly spaced. In some examples, two electrocautery wires 606 are circumferentially spaced about 180 degrees apart. In other examples, more than two electrocautery wires 606 are circumferentially spaced less than 180 degrees apart. As illustrated in FIG. 14B, electrocautery wires 606 (and corresponding electrocautery wire lumens 632) are generally positioned at the same radial distance from a center of multi-lumen shaft 630.
  • clcctrocautcry wires 606 can be rotated together. Each individual one of electrocautery wires 606 creates a corresponding portion of a circumferential cut when the wires are rotated. For example, each portion can be an arc that is less than 360 degrees. In one example, where two electrocautery wires 606 are spaced 180 degrees apart, each of the two electrocautery wires 606 can create half (i.e., a 180-degree arc) of a full circumferential cut through tissue wall TW.
  • each of the more than two clcctrocautcry wires 606 can create less than half (c.g., a third, a quarter, a sixth, etc.) of a full circumferential cut through tissue wall TW. Because electrocautery wires 606 are positioned at the same radial distance within multi-lumen shaft 630, rotation of the wires causes each respective cut portion from an individual wire to extend into the cut portion from the immediately adjacent wire (in the direction of rotation), to create one continuous cut through tissue wall TW.
  • Creating multiple cut portions in parallel can improve the safety and efficiency of device 600 because creating multiple cut portions in parallel reduces the overall time needed for the shunting procedure and specifically reduces the amount of time when electrocautery wires 606 are rotating. Moreover, movement is also reduced or minimized because rotation of 180 degrees (or less) for each individual electrocautery wire can cut along 360 degrees of tissue.
  • DEVICE 700 (FIGS. 15A-15B)
  • FIG. 15A is a schematic cross-sectional side view of electrocautery shunting device 700 extending through opening TO in tissue wall TW and including multi-lumen shaft 730 with multiple radial distance lumens 732 for electrocautery wire 706.
  • FIG. 15B is a schematic cross- sectional front view of electrocautery shunting device 700 taken at line 15B-15B of FIG. 15 A showing electrocautery wire 706 in radial distance lumen 732A of multiple radial distance lumens 732.
  • FIGS. 15A-15B will be discussed together.
  • electrocautery shunting device 700 (also referred to herein as “device 700”) includes elongate tubular body 701 and nosecone 704. Device 700 further includes electrocautery wire 706, and guidewire 708. Elongate tubular body 701 includes multilumen shaft 730.
  • FIG. 15B shows radial distance lumens 732A-732C (referred to collectively and individually herein as radial distance lumen(s) 732) with corresponding radii R1-R3 and guidewire lumen 734 of multi-lumen shaft 730.
  • FIG. 15A further shows tissue wall TW.
  • Device 700 has a generally similar structure and design to device 500 described above in reference to FIGS. 13A-13B, except device 700 includes radial distance lumens 732. Details of similar features or components will not be repeated in this section, except to the extent there are any differences. Radial distance lumens 732 are described here with respect to device 700 but can also be included in any of the examples of an electrocautery shunting device described herewith, including devices 100, 200, 300, 400, 500, and 600, or in combination shunting system 900.
  • Multi-lumen shaft 730 includes a plurality of lumens positioned at different radial distances. More specifically, multi-lumen shaft 730 includes multiple radial distance lumens 732 with corresponding radii R1-R3, as measured from a central longitudinal axis of multi-lumen shaft 730 that is generally represented in FIGS. 15A-15B by guidewire 708. As shown in FIG. 15B, radial distance lumen 732A corresponds to radius Rl, radial distance lumen 732B corresponds to radius R2, and radial distance lumen 732C corresponds to radius R3. Although the example shown in FIGS.
  • 15A-15B includes three radial distance lumens 732, other examples can include more or fewer than three radial distance lumens 732.
  • Each radial distance lumen 732 permits creating a different diameter circumferential cut in tissue wall TW. That is, the size of the resulting shunt can correspond to one of radii R1-R3, depending on which one of radial distance lumens 732 is used.
  • the radial spacing of radial distance lumens 732 can be very small to permit high resolution sizing of resulting shunts.
  • Electrocautery wire 706 can be received in any one of radial distance lumens 732.
  • one of radial distance lumens 732 can be selected to receive electrocautery wire 706 according to patient- specific requirements.
  • An appropriate one of radial distance lumens 732 can be selected either prior to insertion of device 700 into the body or after insertion.
  • electrocautery wire 706 can be an unattached electrocautery wire with the characteristics described previously with reference to FIG. 9, such that electrocautery wire 706 can be inserted into the desired one of radial distance lumens 732 and advanced distally to cut tissue wall TW.
  • Multi-lumen shaft 730 including radial distance lumens 732 allows shunt size to be tailored to each patient. That is, in addition to controlling shunt size by controlling the length of a circumferential cut (e.g., as described previously with reference to FIG. 6B), radial distance lumens 732 allow for controlling the diameter of the circumferential cut.
  • a shunt could be conservatively sized initially, and then adjusted to a larger size during a shunt formation procedure. For instance, patient parameters, such as pressure values received from a pressure sensor (e.g., integrated sensors 326 shown in FIG. 11 or independent sensors 428 shown in FIG.
  • FIG. 16 is a schematic cross-sectional view of heart H showing magnetic shunting system 800.
  • magnetic shunting system 800 (also referred to herein as “system 800”) includes first catheter 810 and second catheter 812, which are connected to electrical source 805 via electrical connection 807.
  • First catheter 810 includes first magnet 814
  • second catheter 812 includes second magnet 816.
  • FIG. 16 further shows heart H, vasculature V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, superior vena cava SVC, inferior vena cava IVC, pulmonary veins PVS, mitral valve MV, coronary sinus CS, thebesian valve BV, inter-atrial septum IS, and fossa ovalis FO.
  • Magnetic shunting system 800 is a catheter-based shunting system for forming an implantless shunt.
  • system 800 can be used to form an implantless shunt through a tissue wall between left atrium LA and coronary sinus CS.
  • system 800 can be used to form an implantless shunt between other anatomically adjacent chambers or vessels of the cardiovascular’ system of a patient, such as along a pressure gradient between a relatively higher-pressure chamber or vessel and a relatively lower-pressure chamber or vessel.
  • System 800 can include multiple catheters. Specifically, system 800 includes first catheter 810 and second catheter 812. Each of first catheter 810 and second catheter 812 can include a handle or other similar component to be grasped by a physician or other user to control movement of the catheter, which can further include a number of ports through which guidewires, tubes, fluids, or other components or elements may be passed. Each of first catheter 810 and second catheter 812 includes a flexible shaft or tube that can be moved through a patient’s heart and/or vasculature.
  • First catheter 810 is inserted into a first anatomical chamber or vessel.
  • first catheter 810 is inserted into coronary sinus CS.
  • first catheter 810 can be inserted from superior vena cava SVC, through right atrium RA, and into coronary sinus CS via the ostium of the coronary sinus.
  • the distal portion of first catheter 810 is shown in dashed lines within coronary sinus CS in FIG. 16.
  • Second catheter 812 is inserted into a second anatomical chamber or vessel. In the example shown in FIG. 16, second catheter 812 is inserted into left atrium LA.
  • second catheter 812 can be inserted from inferior vena cava IVC, through right atrium RA, and across inter-atrial septum IS into left atrium LA.
  • the overall size of second catheter 812 can be minimized. This can allow an opening in inter-atrial septum IS to be likewise minimized, such that the opening may close spontaneously.
  • the main operating components of system 800 can be contained in first catheter 810 to reduce the number of components contained in second catheter 812 and minimize the size of second catheter 812.
  • second catheter 812 can be inserted through a pre-existing opening in inter-atrial septum IS. In the example shown in FIG.
  • first catheter 810 and second catheter 812 are aligned across the tissue wall between left atrium LA and coronary sinus CS, with first catheter 810 in coronary sinus CS and second catheter 812 in left atrium LA.
  • first catheter 810 can be in left atrium LA and second catheter 812 can be in coronary sinus CS.
  • first catheter 810 and second catheter 812 can be aligned across a tissue wall between other anatomically adjacent chambers or vessels.
  • First catheter 810 and second catheter 812 are connected to electrical source 805 via electrical connection 807, as indicated with dashed lines in FIG. 16.
  • Electrical source 805 is any suitable electrical source for supplying electrical current to first catheter 810 and second catheter 812.
  • electrical source 805 can be positioned externally to a patient’s body during a shunt formation procedure.
  • Electrical connection 807 can be a wired connection between electrical source 805 and first catheter 810 and/or second catheter 812.
  • First catheter 810 includes first magnet 814, and second catheter 812 includes second magnet 816. At least one of first magnet 814 and second magnet 816 is an electromagnet that is selectively magnetized. For example, one of first magnet 814 and second magnet 816 can be selectively magnetized to align with the other magnet once first catheter 810 and second catheter 812 are moved to a desired location along the tissue wall. First magnet 814 and second magnet 816 function together to maintain the alignment of first catheter 810 and second catheter 812 in a desired position for forming an implantless shunt.
  • FIG. 17 is a schematic cross-sectional side view of magnetic shunting system 800 showing extrudable wire 818.
  • FIG. 17 shows additional details of magnetic shunting system 800.
  • FIG. 17 shows magnetic shunting system 800, including first catheter 810, second catheter 812, first magnet 814, second magnet 816, and extrudable wire 818.
  • First magnet 814 further includes wire passage 820.
  • Second magnet 816 further includes wire receiver 822.
  • Wire passage 820 includes first insulation layer 824, and wire receiver 822 includes second insulation layer 826.
  • FIG. 17 further shows wire extrusion direction EX and tissue wall TW, including first side TW1 and second side TW2.
  • First catheter 810 includes extrudable wire 818.
  • Extrudable wire 818 is configured as a cutting implement for creating an opening through tissue wall TW, which, for example, can be the tissue wall between left atrium LA and coronary sinus CS.
  • extrudable wire 818 can utilize electrocautery, radio frequency (RF), ultrasound, or other ablation technologies.
  • extrudable wire 818 can be connected via electrical connection 807 (shown in FIG. 16) to electrical source 805 (shown in FIG. 16) to receive electrical current.
  • Extrudable wire 818 can be contained within an internal lumen of first catheter 810 and advanced through first catheter 810 to wire passage 820.
  • a size and shape of extrudable wire 818 approximately corresponds to the size and shape of a shunt formed using system 800. Specifically, a cross-sectional area of extrudable wire 818 can correspond to an area of the resulting shunt. In one example, extrudable wire 818 can be sized and shaped such that the area of the resulting shunt is equivalent to an area of a five- to ten- millimeter (5-10 mm) diameter circle.
  • First magnet 814 includes wire passage 820.
  • Wire passage 820 is an opening through first magnet 814 to an exterior of first catheter 810.
  • Wire passage 820 is configured to allow extrudable wire 818 to pass through first magnet 814. Accordingly, wire passage 820 can be continuous with an internal lumen of first catheter 810 in which extrudable wire 818 is contained.
  • Second magnet 816 includes wire receiver 822.
  • Wire receiver 822 is a cavity or hollow space within second magnet 816 that is configured to receive extrudable wire 818. As will be described in greater detail below with reference to FIGS. 18A-20B, wire receiver 822 can be sized and shaped to correspond to a size and shape of extrudable wire 818.
  • Wire passage 820 includes first insulation layer 824, and wire receiver cavity 822 includes second insulation layer 826.
  • First insultation layer 824 and second insulation layer 826 can be formed of any suitable electrically insulating material.
  • First insulation layer 824 covers an exposed surface of wire passage 820 to prevent extrudable wire 818 from contacting first magnet 814 within wire passage 820.
  • second insulation layer 826 covers an exposed surface of wire receiver 822 to prevent extrudable wire 818 from contacting second magnet 816 within wire receiver 822.
  • first catheter 810 is inserted along first side TW1 of tissue wall TW
  • second catheter 812 is inserted along second side TW2 of tissue wall TW.
  • Tissue wall TW can include multiple layers of tissue.
  • First catheter 810 and second catheter 812 are aligned.
  • first catheter 810 and second catheter 812 can be aligned using fluoroscopic visualization.
  • first magnet 814 is configured to face first side TW1 when first catheter 810 is inserted along first side TW1.
  • second magnet 816 is configured to face second side TW2 when second catheter 812 is inserted along second side TW2.
  • first side TW 1 is on a coronary sinus side of tissue wall TW and second side TW2 is on a left atrial side of tissue wall TW.
  • first catheter 810 and second catheter 812 aligns wire passage 820 of first magnet 814 and wire receiver 822 of second magnet 816.
  • One of first magnet 814 and second magnet 816 is magnetized to maintain alignment of first catheter 810 and second catheter 812 across tissue wall TW.
  • First magnet 814 and second magnet 816 are attracted together with tissue wall TW sandwiched therebetween.
  • Extrudable wire 818 is extruded through wire passage 820 in wire extrusion direction EX, as indicated by the arrow in FIG. 17. As it is extruded, extrudable wire 818 pushes against and cuts through, or ablates, tissue wall TW from first side TW1 to second side TW2 in the region bounded by first magnet 814 and second magnet 816.
  • extrudable wire 818 can be energized using electrocautery, RF, or ultrasound technology to cut through tissue wall TW.
  • tissue wall TW can also be fused by extrudable wire 818.
  • the alignment of first magnet 814 and second magnet 816, and the inclusion of respective first insulation layer 824 and second insulation layer 826, ensures that only the desired portion of tissue wall TW is ablated, which minimizes or prevents damage to other parts of the tissue.
  • extrudable wire 818 is captured in wire receiver 822. Cutting through tissue wall TW with extrudable wire 818 forms a patent shunt through tissue wall TW. As described previously, the shunt created by extrudable wire 818 corresponds to a size and shape of extrudable wire 818. In some examples, such as examples where extrudable wire 818 is an electrocautery wire, the edges of the resulting shunt are immediately sealed upon contact with extrudable wire 818.
  • tissue wall comprises multiple tissue layers, such as a tissue wall between the left atrium and the coronary sinus
  • the edges of adjacent tissue layers of the resulting shunt are welded together upon contact with the extrudable wire 818, fusing the adjacent tissue layers together around the resulting shunt and thereby preventing fluid from seeping through the shunt wall and between adjacent tissue layers.
  • extrudable wire 818 can be retracted through the opening in tissue wall TW into first catheter 810, and both first catheter 810 and second catheter 812 can be removed from the body.
  • FIG. 18A is a schematic front perspective view of first magnet 814A and extrudable wire 818A.
  • FIG. 18B is a schematic front perspective view of second magnet 816A and wire receiver 822A that is complimentary (e.g., in size and shape) to extrudable wire 818A.
  • FIG. 19A is a schematic front perspective view of first magnet 814B and extrudable wire 818B.
  • FIG. 19B is a schematic front perspective view of second magnet 816B and wire receiver 822B that is complimentary (e.g., in size and shape) to extrudable wire 818B.
  • FIG. 20A is a schematic front perspective view of first magnet 814C and extrudable wire 818C.
  • FIG. 20B is a schematic front perspective view of second magnet 816C and wire receiver 822C that is complimentary (e.g., in size and shape) to extrudable wire 818C.
  • FIGS. 18A-20B will be discussed together.
  • first magnets 814A, 814B, and 814C is an example of first magnet 814, as shown in FIGS. 16-17; each of extrudable wires 818A, 818B, and 818C is an example of extrudable wire 818, as shown in FIGS. 16-17; each of second magnets 816A, 816B, and 816C is an example of second magnet 816, as shown in FIGS. 16-17; and each of wire receivers 822A, 822B,, and 822C is an example of wire receiver 822, as shown in FIGS. 16-17.
  • wire receiver 822A is complementary to extrudable wire 818A.
  • Wire receiver 822A is sized and shaped such that extrudable wire 818A fits closely therein.
  • the cross-sectional area of extrudable wire 818A and the cross-sectional area of wire receiver 822 A have complementary wavy (or jagged) edges.
  • wire receiver 822B is complementary to extrudable wire 818B.
  • Wire receiver 822B is sized and shaped such that extrudable wire 818B fits closely therein.
  • the cross-sectional area of extrudable wire 818B and the cross-sectional area of wire receiver 822B have complementary round edges.
  • wire receiver 822C is complementary to extrudable wire 818C.
  • Wire receiver 822C is sized and shaped such that extrudable wire 818C fits closely therein.
  • the cross-sectional area of extrudable wire 818C and the cross- sectional area of wire receiver 822C have complementary rectangular edges.
  • extrudable wires and wire receivers shown in FIGS. 18A-20B represent design flexibility in the components of system 800 for forming implantless shunts. For instance, certain shapes of extrudable wires may help the wire pass effectively through the tissue wall. Certain shapes may also help seal tissue edges so that the resulting shunt remains patent.
  • system 800 creates an implantless shunt between anatomically adjacent chambers or vessels of the cardiovascular system of a patient, such as between left atrium LA and coronary sinus CS (shown in FIG. 16), to shunt blood from a relatively higher-pressure chamber or vessel into a relatively lower-pressure chamber or vessel.
  • system 800 can create an implantless shunt to mitigate elevated LAP, such as in patients experiencing heart failure or other medical conditions.
  • an implantless shunt formation procedure carried out using system 800 can be a relatively short intervention, thereby reducing patient risk posed by more extensive procedures.
  • Another advantage of using system 800 is that no stent or similar device is implanted in the body to form or maintain a shunt opening.
  • a shunt formation procedure using system 800 may not leave any implanted devices behind in the body at all. Forming an implantless shunt can reduce the complexity of the shunt formation procedure and further reduce the risk for the patient.
  • magnetic alignment of first catheter 810 and second catheter 812 in system 800 can facilitate effective shunt formation by allowing for more precise cutting of tissue wall TW to form an implantless shunt therethrough.
  • FIG. 21 is a schematic cross-sectional side view of combination shunting system 900.
  • combination shunting system 900 (also referred to herein as “system 900”) includes first catheter 910, second catheter 912, first magnet 914, second magnet 916, and extrudable and rotatable wire 918, which are connected to electrical source 905 via electrical connection 907.
  • First magnet 914 further includes wire passage 920.
  • Second magnet 916 further includes wire receiver 922.
  • Wire passage 920 includes first insulation layer 924, and wire receiver 922 includes second insulation layer 926.
  • FIG. 21 further shows wire extrusion direction EX and tissue wall TW, including first side TW 1 and second side TW2.
  • System 900 has a generally similar components and design to system 800 described above in reference to FIGS. 16-20B, except system 800 includes extrudable and rotatable wire 918 instead of extrudable wire 818. Details of similar features or components will not be repeated in this section, except to the extent there are any differences.
  • first catheter 910 can generally include any components or features of the electrocautery shunting devices described previously with reference to FIGS. 3A-15B, such as a multi-lumen shaft, etc.
  • Extrudable and rotatable wire 918 can have the characteristics of unattached electrocautery wire 206 described previously with reference to FIG. 9 in combination with the characteristics of extrudable wire 818 described previously with reference to FIGS. 16-20B.
  • extrudable and rotatable wire 918 is configured to be extruded from first catheter 910 and then rotated to form an implantless shunt.
  • Extrudable and rotatable wire 918 is extruded through wire passage 920 in wire extrusion direction EX, as indicated by the arrow in FIG. 21.
  • Extrudable and rotatable wire 918 cuts through tissue wall TW from first side TW1 to second side TW2.
  • extrudable and rotatable wire 918 can be energized using electrocautery, RF, or ultrasound technology to create an opening through tissue wall TW. After cutting through tissue wall TW, extrudable and rotatable wire 918 is received in wire receiver 922 of second magnet 916.
  • Extrudable and rotatable wire 918 can then be rotated, as described previously with reference to FIGS. 6A-7B, to create a circumferential cut in tissue wall TW.
  • One of first magnet 914 and second magnet 916 can be magnetized to hold first catheter 810 and second catheter 812 in alignment as extrudable and rotatable wire 918 is extruded and rotated. Accordingly, system 900 combines advantages of the rotatable electrocautery wire techniques described with reference to FIGS. 3A-15B and the magnetic alignment techniques described with reference to FIGS. 16-20B to form an implantless shunt.
  • Existing left-to-right atrial shunt therapies decrease pressure in the left atrium of the heart by shunting blood into the right atrium. Generally, the higher pressure in the left atrium prevents backflow from the right atrium across the shunt. However, transient pressure inversions can enable backflow of debris-containing blood from the right atrium into the left atrium. Accordingly, left-to-right atrial shunt therapies performed according to existing techniques can be associated with an increased risk of ischemic events.
  • Method 1500 places a shunt across a tissue wall connecting the coronary sinus to the left atrium.
  • the shunt formed according to method 1500 shunts blood from the left atrium to the right atrium via the coronary sinus, thereby reducing pressure in the left atrium.
  • providing a shunt that connects the left atrium to the coronary sinus increases the total flow length between the right atrium and the shunt to the left atrium, decreasing the likelihood that debris-containing blood can flow into the left atrium during transient pressure inversions between the left atrium and right atrium. Accordingly, method 1500 reduces the risk of ischemic events as compared to existing left-to-right atrial shunt therapies.
  • FIGS. 22-31 relate to various systems, methods, and devices for forming shunts (i.e., tissue openings) across tissue walls.
  • FIG. 29, discussed in more detail subsequently, provides a flow diagram of method 1500, which is a method of forming a shunt across a tissue wall between the left atrium and the coronary sinus.
  • FIGS. 22-27 provide various devices that can be used to perform method 1500.
  • FIGS. 22-24 provide various examples of magnetic attractor devices suitable for use in method 1500 (FIG. 29).
  • FIG. 25 provides an example of a magnetic capsule device and
  • FIG. 26 provides an example of a puncture catheter.
  • FIGS. 27-28 provide examples of magnetic shunting assemblies including the magnetic capsule device of FIG. 25 and the puncture catheter of FIG. 26.
  • FIGS. 30A-30I provide illustrations of the state of a patient’s heart after each step of method 1500.
  • FIG. 31 provides an alternative puncture catheter that is usable with method 1500.
  • any of the devices of FIGS. 22-25 can be referred to as a “magnetic shunting device” herein and any of the assemblies of FIGS. 27-28 can be referred as a “magnetic shunting assembly.”
  • a combination of a magnetic attractor device (e.g., a magnetic attractor device of FIGS. 22-24) and a magnetic capsule device (e.g., the magnetic capsule device of FIG. 23) or magnetic capsule assembly (e.g., a magnetic capsule assembly of FIGS. 27-28) can be referred to as a “magnetic shunting assembly.”
  • DEVICE 1000 DEVICE 1000
  • FIG. 22 is a schematic cross-sectional side view of magnetic attractor device 1000, which is one example of a magnetic attractor device suitable for use as part of a magnetic shunting system and also for use in method 1500 (FIG. 29).
  • Magnetic attractor device 1000 includes elongate tubular body 1002, magnetic head 1004, and distal end 1006.
  • Elongate tubular’ body 1002 includes surface 1008 and lumen 1010.
  • Magnetic head 1004 includes surface 1012 and lumen 1014.
  • Magnetic attractor device 1000 is a catheter-based device for aligning a magnetic capsule device (e.g., magnetic capsule device 1300 of FIG. 25 and FIGS. 26-27) with a tissue wall. Magnetic attractor device 1000 is capable of aligning a magnetic capsule device via magnetic attraction of magnetic head 1004 with the magnetic capsule of the magnetic capsule device. Magnetic attractor device 1000 includes elongate tubular body 1002 and magnetic head 1004.
  • a proximal portion (i.e., opposite distal end 1010; not shown) of magnetic attractor device 1000 can include a handle or other similar component to be grasped by a physician or other user to control movement of magnetic attractor device 1000, which can further include a number of ports through which guidewires, tubes, fluids, or other components or elements may be passed.
  • Elongate tubular body 1002 is a length of catheter (a flexible shaft, tube, etc.) that can be moved through a patient’s heart and/or vasculature.
  • Elongate tubular’ body 1002 includes exterior surface 1008 and lumen 1010 extending therethrough.
  • Lumen 1010 is defined by elongate tubular body 1002.
  • a capsule or outer sheath formed of a suitable flexible and durable material forms elongate tubular’ body 1002.
  • Lumen 1010 is a longitudinal opening or passage that extends axially through elongate tubular body 1002.
  • elongate tubular body 1002 may include two or more lumens.
  • Magnetic head 1004 extends axially out war’d from a distal portion of elongate tubular body 1002 and defines distal end 1006 of magnetic attractor device 1000.
  • Magnetic head 1004 is a magnet suitable for use with a magnetic capsule device (e.g., magnetic capsule device 1300) and, in particular, for aligning the magnetic capsule device with magnetic head 1004 across a tissue wall.
  • Magnetic head 1004 includes surface 1012 and lumen 1014.
  • Surface 1012 defines an outer radial extent of magnetic head 1004.
  • Lumen 1014 is defined by the interior surface of magnetic head 1004 and is a longitudinal opening or passage that extends axially through magnetic head 1004.
  • Magnetic head 1004 is generally shaped as a hollow cylinder in the example depicted in FIG.
  • lumen 1014 is generally cylindrical in shape.
  • magnetic head 1004 can have any suitable shape and define lumen 1014 to be any suitable shape.
  • Lumen 1014 is fluidly connected to lumen 1010 such that guide wires, etc. can be passed through lumen 1010 and into lumen 101 and, further, such that magnetic attractor device 1000 can be passed over a guide wire via lumens 1010 and 1014.
  • Magnetic head 1004 can be a permanent magnet or can be selectively magnetizable (e.g., an electromagnetic). In other examples, magnetic head 1004 can be a ferro metal or another magnetizable material.
  • FIG. 23 is a schematic cross-sectional side view of magnetic attractor device 1100, which is another example of a magnetic attractor device suitable for use as part of a magnetic shunting system and also for use in method 1500 (FIG. 29).
  • Magnetic attractor device 1100 includes elongate tubular body 1102, magnetic head 1104, and distal end 1106.
  • Elongate tubular body 1102 includes surface 1108 and lumen 1110.
  • Magnetic head 1104 includes surface 1112, lumen 1114, and recess 1116.
  • Magnetic attractor device 1100 is generally similar to magnetic device 1000 described previously and particularly in the discussion of FIG. 22.
  • Elongate tubular body 1102, magnetic head 1104, distal end 1106, surface 1108, lumen 1110, surface 1112, and lumen 1114 of magnetic attractor device 1100 are substantially similar to elongate tubular body 1002, magnetic head 1004, distal end 1006, surface 1008, lumen 1010, surface 1012, and lumen 1014, respectively, of magnetic attractor device 1000 (FIG. 22).
  • the descriptions of the aforementioned components of magnetic attractor device 1000 (FIG. 22) are applicable to corresponding components of magnetic attractor device 1100.
  • Magnetic attractor device 1100 also includes recess 1116 formed in magnetic head 1104.
  • Recess 1116 is a recessed portion of surface 1112 such that the diameter of magnetic head 1104 is reduced at recess 1116 relative to axial regions of magnetic head 1104 outside of recess 1116 (e.g., distal end 1106).
  • Recess 1116 improves alignment of a magnetic capsule device (e.g., magnetic capsule device 1300, discussed subsequently) to magnetic head 1104 of magnetic attractor device 1100.
  • recess 1116 can also reduce the likelihood that a magnetic capsule device is displaced from magnetic head 1104 of magnetic attractor device 1100.
  • recess 1116 is formed in one side of magnetic head 1104, such that recess 1116 is formed in less than the entire circumferential extent of magnetic head 1104. Further, in the depicted example, recess 1116 is formed in less than an entire axial extent of magnetic head 1104 (i.e., in the direction in which lumen 1114 extends) such that recess 1116 does not extend over distal end 1106 or the portion of magnetic head 1104 adjoining elongate tubular body 1102. In other examples, recess 1 116 can be formed over the entire or substantially the entire circumferential extent and/or the entire or substantially the entire axial extent of magnetic head 1104.
  • FIG. 24 is a schematic cross-sectional side view of magnetic attractor device 1200, which is another example of a magnetic attractor device suitable for use as part of a magnetic shunting system and also for use in method 1500 (FIG. 29).
  • Magnetic attractor device 1200 includes elongate tubular- body 1202, magnetic head 1204, and distal end 1206.
  • Elongate tubular body 1202 includes surface 1208 and lumen 1210.
  • Magnetic head 1204 includes magnet 1212.
  • Magnetic attractor device 1200 is generally similar to magnetic attractor device 1000 described previously and particularly in the discussion of FIG. 22.
  • Elongate tubular body 1202, magnetic head 1204, distal end 1206, surface 1208, and lumen 1210 of magnetic attractor device 1200 are substantially similar to elongate tubular- body 1002, magnetic head 1004, distal end 1006, surface 1008, and lumen 1010, respectively, of magnetic attractor device 1000 (FIG. 22).
  • the descriptions of the aforementioned components of magnetic attractor device 1000 (FIG. 22) are applicable to corresponding components of magnetic attractor device 1200.
  • Magnetic head 1204 is formed by magnet 1212, which is disposed on surface 1208 of elongate tubular- body 1202. Unlike magnetic head 1004 and magnetic head 1104 of magnetic attractor device 1000 (FIG. 22) and magnetic attractor device 1100 (FIG. 23), respectively, magnetic head 1204 is not disposed axially adjacent to and extending from elongate tubular body 1202. Rather, an axial end of elongate tubular- body 1202 forms distal end 1206. Magnet 1212 is disposed on surface 1208 and an axially distal end of magnet 1212 is aligned with distal end 1206.
  • magnet 1212 is located on one side of elongate tubular body 1202, such that magnet 1212 does not extend over the entire circumferential extent of elongate tubular- body 1202.
  • magnet 1212 can wrap around the entire circumferential extent or substantially the entire circumferential extent of elongate tubular body 1202.
  • Magnet head 1204 does not include or define a separate lumen, and lumen 1210 extends to distal end 1206.
  • FIG. 24 is a schematic cross-sectional side view of magnetic capsule device 1300, which is a component of magnetic capsule assembly 1350 and of magnetic capsule assembly 1360, discussed subsequently and particularly with respect to the descriptions of FIG. 27 and FIG.
  • Magnetic capsule device 1300 includes elongate tubular body 1302, magnetic head 1304, and distal end 1306.
  • Elongate tubular body 1302 includes surface 1308 and lumen 1310.
  • Magnetic head 1304 includes surface 1312 and lumen 1314.
  • Magnetic capsule device 1300 is one example of a magnetic capsule device suitable for use with method 1500 and, further, for use in combination with a magnetic attractor device (e.g., magnetic attractor device 1000, 1100, 1200; FIGS. 22-24) in a magnetic shunting system.
  • a magnetic attractor device e.g., magnetic attractor device 1000, 1100, 1200; FIGS. 22-24
  • Elongate tubular body 1302, surface 1308, and lumen 1310 are substantially similar to elongate tubular body 1002, surface 1008, and lumen 1110 of magnetic attractor device 1000 (FIG. 10), respectively, and the descriptions here of elongate tubular body 1002, surface 1008, and lumen 1110 are respectively applicable to elongate tubular body 1302, surface 1308, and lumen 1310.
  • Magnetic head 1304 extends from an axially-distal end of elongate tubular body 1302 and forms distal end 1306 of magnetic capsule device 1300.
  • Magnetic head 1304 includes surface 1312, which defines an outer radial extent of magnetic head 1304, as well as lumen 1314, which is defined by the inner radial extent of magnetic head 1304.
  • Lumen 1314 is a longitudinal opening or passage that extends axially through magnetic head 1304.
  • Magnetic head 1304 can be a permanent magnet or can be selectively magnetizable (e.g., an electromagnetic). In other examples, magnetic head 1304 can be a ferrometal or another magnetizable material.
  • Lumen 1314 is generally sized to permit a puncturing catheter (e.g., puncturing catheter 1320, discussed subsequently in the description of FIG. 26) to advance through lumen 1314 and form a shunt in a tissue wall.
  • a puncturing catheter e.g., puncturing catheter 1320, discussed subsequently in the description of FIG. 26
  • an inner diameter of lumen 1314 i.e., a distance from opposed points on the inner surface of magnetic head 1304
  • an inner diameter of lumen 1314 is larger (i.e., has a larger radius) than an inner diameter of lumen 1014 of magnetic attractor device 1000 (FIG. 10) and/or of lumen 1114 of magnetic attractor device 1100 (FIG. 11).
  • FIG. 24 is a schematic side view of puncture catheter 1320 , which is a component of magnetic shunting assembly 1350 and magnetic shunting assembly 1360, discussed subsequently and particularly with respect to the descriptions of FIG. 27 and FIG. 28, respectively.
  • Puncture catheter 1320 includes elongate body 1322, surface 1324, puncture tip 1326, and distal end 1328.
  • Puncture catheter 1320 is one example of a puncturing catheter disclosed herein and is capable of puncturing a tissue wall to form a shunt.
  • the use of a puncturing catheter as a component of a magnetic shunting device e.g., magnetic shunting assembly 1350; FIG. 27
  • method 1500 FIG. 30
  • Elongate body 1322 is a length of catheter (a flexible shaft, tube, etc.) that can be moved through a patient’ s heart and/or vasculature, as well as through larger catheter devices, such as magnetic capsule device 1300 (FIG. 25).
  • a proximal portion (i.e., opposite distal end 1328; not shown) of puncture catheter 1320 can include a handle or other similar component to be grasped by a physician or other user to control movement of puncturing catheter 1320, which can further include a number of ports through which guidewires, tubes, fluids, or other components or elements may be passed.
  • a capsule or outer sheath formed of a suitable flexible and durable material forms elongate body 1322.
  • Surface 1324 defines an outer radial extent of elongate body 1322.
  • Puncture tip 1326 extends from an axially-distal end of elongate body 1322 to distal end 1328.
  • puncture tip 1326 is a needle, but in other examples, puncture tip 1326 can be any suitable device, component, extension, etc. for forming a shunt through a tissue wall.
  • puncture tip 1326 can also be or include one or more of a drill head including a helical cutting edge, an RF-conducting conducting wire, a tissue punch (e.g., a rigid and hollow cylindrical punch), etc.
  • FIG. 27 is a schematic cross-sectional side view of magnetic capsule assembly 1350, which is an example of a magnetic shunting assembly suitable for forming a tissue opening or shunt when used in combination with a magnetic attractor device (e.g., one of magnetic attractor devices 1000, 1100, 1200).
  • Magnetic capsule assembly 1350 includes magnetic capsule device 1300 and puncturing catheter 1320.
  • puncture catheter 1320 extends through lumen 1310 and lumen 1314 of magnetic capsule device 1300. Puncture catheter 1320 and magnetic capsule device 1300 can be moved relative to each other, such that puncture catheter 1320 can be advanced through and withdrawn from lumen 1310 and lumen 1314.
  • magnetic capsule device 1300 can be advanced over and withdrawn over surface 1324 and puncture tip 1326 of puncture catheter 1320.
  • puncture catheter 1320 can be advanced to move distal end 1328 past distal end 1306 of magnetic capsule device 1300 and into a tissue wall, thereby forming a shunt or hole in the tissue wall.
  • FIG. 28 is a schematic cross-sectional side view of magnetic capsule assembly 1360, which is a further example of a magnetic shunting assembly suitable for use with a magnetic attractor device (e.g., one of magnetic attractor devices 1000, 1100, 1200) in a magnetic shunting system.
  • Magnetic capsule assembly 1360 includes magnetic capsule device 1300, puncturing catheter 1320, delivery catheter 1362, and implantable device 1364.
  • Delivery catheter 1362 is a length of catheter (a flexible shaft, tube, etc.) sized to be able to be advanced over puncture catheter 1320 and within magnetic capsule device 1300.
  • Delivery catheter 1362 carries implantable device 1364, which can be implanted in a shunt created by puncture catheter 1320 to prevent the shunt from narrowing or closing.
  • delivery catheter 1362 can be advanced along the length of puncture catheter 1320 to the position of the tissue shunt created by puncture catheter 1320.
  • Implantable device 1364 can then be deployed in the shunt using any suitable mechanism.
  • Implantable device 1364 can be, for example, a stent.
  • FIG. 29 is a flow diagram of method 1500, which is a method of forming a shunt across a tissue wall using a magnetic shunting system.
  • Method 1500 includes steps 1502-1518 of: advancing a first guidewire into the coronary sinus and advancing a second guidewire into the left atrium (step 1502); advancing a first catheter including a magnetic attractor over the first guidewire and advancing a second catheter including a magnetic capsule over the second guidewire (step 1504); activating the magnetic attractor to attract the magnetic capsule to the magnetic attractor across a tissue wall between the coronary sinus and the left atrium (step 1506); advancing a puncture catheter including a puncture tip through the second catheter (step 1508); puncturing the tissue wall between the coronary sinus and the left atrium with the puncture tip to form an opening in the tissue wall (step 1510); advancing the second catheter through the opening in the tissue wall (step 1512); removing the puncture catheter and the first catheter (step 1514); advancing a third guidewire through the
  • FIGS. 3OA-3OJ are cross-sectional side views of a heart showing the operation of a magnetic shunting system to create a shunt according to method 1500.
  • FIG. 30A illustrates step 1502;
  • FIGS. 30B-C illustrate step 1504;
  • FIG. 30D illustrates step 1506;
  • FIG. 30E illustrates step 1508;
  • FIG. 30F illustrates step 1510;
  • FIG. 30G illustrates step 1512;
  • FIG. 30H illustrates step 1514;
  • FIG. 301 illustrates step 1516; and
  • FIG. 30J illustrates step 1518.
  • Each step of method 1500 is discussed herein with reference to the corresponding one(s) of FIGS. 30A-J.
  • FIGS. 30A-J depicts the left atrium LA, the coronary sinus CS, and the right atrium RA of a heart.
  • FIGS. 30A-J also collectively depict tissue wall TW, shunt TO, guide wire 1602, guide wire 1604, catheter 1610, magnetic attractor 1612, catheter 1620, magnetic capsule 1622, puncture catheter 1630, puncture tip 1632, and guide wire 1642.
  • Tissue wall TW is a tissue wall formed between coronary sinus CS and left atrium LA.
  • Tissue wall TW can include multiple layers of tissue.
  • Shunt TO is a tissue opening in tissue wall TW.
  • Guide wire 1602, guide wire 1604, and guide wire 1642 are flexible wires that can be inserted into tissue and used to navigate vessels, chambers, etc. of a heart. When inserted into a patient’s heart and/or vasculature, guide wire 1602, guide wire 1604, and guide wire 1642 can be used to guide catheters and other devices to particular locations, regions, etc. of the patient’s heart and/or vasculature by advancing the catheter over guide wires 1602, 1604, and 1642.
  • Catheter 1610 is a magnetic attractor device and can be substantially similar to any of magnetic attractor devices 1000, 1100, 1200 (FIGS. 22-24).
  • Catheter 1610 includes magnetic attractor 1612, which is a magnet for attracting magnetic capsule 1622 and can be the same as or similar to any of magnetic heads 1004, 1104, 1204 (FIGS. 22-24).
  • Catheter 1620 is a magnetic capsule device and can be the same as or similar to magnetic capsule device 1300.
  • Magnetic capsule 1622 is a magnetic component of catheter 1620 for guiding the distal end of catheter 1620 to magnetic attractor 1612. Magnetic capsule 1622 can be the same as or similar to magnetic head 1304.
  • Puncture catheter 1630 includes puncture tip 1632 and is used to form shunt TO in tissue wall TW. Puncture catheter 1630 and puncture tip 1632 can be the same as or similar to puncture catheter 1320 and puncture tip 1326, respectively.
  • a guide wire 1602 is advanced into the coronary sinus and a second guide wire 1604 is advanced into the left atrium.
  • FIG. 30A provides a cross-sectional view of the human heart after guidewire 1602 and guidewire 1604 are advanced according to step 1502. As depicted in FIG. 30A, guide wire 1602 can be advanced into the coronary sinus CS via right atrium RA.
  • step 1504 catheter 1610 is advanced over guide wire 1602 and catheter 1620 is advanced over guide wire 1604.
  • the status of the heart after catheter 1610 is advanced over guide wire 1602 is depicted in FIG. 30B and the status of the heart after catheter 1620 is subsequently advanced over guide wire 1604 as depicted in FIG. 30C.
  • advancing catheter 1610 over guide wire 1602 places magnetic attractor 1612 near tissue wall TW in coronary sinus CS.
  • FIG. 30C advancing catheter 1620 over guide wire 1604 places magnetic capsule 1622 near’ tissue wall TW in left atrium LA.
  • step 1506 magnetic attractor 1612 is activated to attract magnetic capsule 1622 to magnetic attractor 1612 across tissue wall TW extending between coronary sinus CS and left atrium LA.
  • FIG. 30D shows the position of catheter 1610 and catheter 1620, and particularly of magnetic attractor 1612 and magnetic capsule 1622, following step 1506.
  • the distal end of magnetic capsule 1622 i.e., with respect to the orientation of the elongate tubular’ body of catheter 1620
  • the distal end of magnetic capsule 1622 is attracted to a circumferential face of magnetic attractor 1612 (i.e., with respect to the orientation of the elongate tubular body of catheter 1610) across tissue wall TW.
  • Magnetic attractor 1612 can be activated to attract magnetic capsule 1622 using any suitable method.
  • magnetic capsule 1622 can be a permanent magnet or ferromagnet and magnetic attractor 1612 can be an electromagnet.
  • the poles of the magnets of magnetic capsule 1622 and magnetic attractor 1612 can be oriented such that, when magnetic attractor 1612 is activated, magnetic capsule 1622 and magnetic attractor 1612 are attracted across a tissue wall (e.g., tissue wall TW) in the manner depicted in FIG. 30D.
  • step 1508 puncture catheter 1630 is advanced through catheter 1620.
  • FIG. 30E shows the position of catheter 1610, catheter 1620, and puncture catheter 1630 following step 1508. Puncture catheter 1630 is advanced through catheter 1620 to bring puncture tip 1632 near or adjacent to tissue wall TW.
  • Guide wire 1604 can optionally be fully or at least partially withdrawn prior to advancing puncture catheter 1630 through catheter 1620.
  • puncture tip 1632 punctures tissue wall TW to form shunt TO.
  • FIG. 30F depicts the position of catheter 1610, catheter 1620, puncture catheter 1630, and shunt TO following step 1510.
  • Puncture tip 1632 can puncture tissue wall TW by advancing puncture catheter 1630 through the lumen of catheter 1620 and, further, through the opening at the distal end of magnetic capsule 1622.
  • puncture catheter 1630 can be advanced further to displace magnetic attractor 1612 away from tissue wall TS. In some examples, this can provide additional space for magnetic capsule 1622 to be advanced into shunt TO in subsequent step 1512.
  • FIG. 30F shows an embodiment in which magnetic attractor 1612 has been displaced by puncture tip 1632 of puncture catheter 1630 and contacts the wall of coronary sinus CS opposite shunt TO and tissue wall TW.
  • catheter 1620 is advanced through shunt TO in tissue wall TW.
  • magnetic capsule 1622 extends through shunt TO such that the lumen of catheter 1620 is fluidly connected to the interior space of coronary sinus CS.
  • FIG. 30G depicts the position of magnetic capsule 1622 of catheter 1620 following step 1512, as well as the positions of puncture catheter 1630 and catheter 1610.
  • step 1514 puncture catheter 1630 and catheter 1610 are removed from the heart. As depicted in FIG. 30H, following step 1514, catheter 1620 remains in the heart and magnetic capsule 1622 still extends through shunt TO of tissue wall TW. In some examples, magnetic attractor 1612 can be deactivated prior to step 1514.
  • guide wire 1642 is advanced through catheter 1620.
  • guide wire 1642 is advanced through the lumen of catheter 1620 and into coronary sinus 1642 through the opening at the distal end of magnetic capsule 1622.
  • FIG. 301 depicts the position of guide wire 1642 following step 1516.
  • step 1518 catheter 1620 is removed such that only guide wire 1642 remains in the heart.
  • FIG. 30J depicts the heart of FIG. 301 following removal of catheter 1620.
  • guide wire 1620 extends into left atrium LA and from left atrium LA through shunt TO into coronary sinus CS.
  • guide wire 1642 can then be used to form a patent shunt at shunt TO.
  • Guide wire 1642 can be used to guide a delivery catheter (e.g., delivery catheter 1362) to shunt TO.
  • the delivery catheter can be used to deliver an implantable device (e.g., implantable device 1364) to shunt TO that can be deployed to form a patent shunt.
  • a patent shunt can be formed by cauterization of shunt TO.
  • Guide wire 1642 can be used to guide a cauterization device to shunt TO.
  • Cauterization of shunt TO can be performed using any suitable method, such as electrocauterization, burning, etc.
  • magnetic capsule 1622 can become displaced from shunt TO after step 1514 and before guide wire 1642 is advanced in step 1516.
  • method 1500 can be modified so that only puncture catheter 1630 is withdrawn in step 1514. Method 1500 can then proceed to step 1516 to advance guide wire 1642 and both catheter 1610 and catheter 1620 can be withdrawn in step 1518.
  • FIG. 31 is a cross-sectional diagram of a heart at step 1508 of method 1500 showing the use of a magnetic shunting system including puncture catheter 1640 instead of puncture catheter 1630.
  • FIG. 31 shows guide wire 1602, catheter 1610, magnetic attractor 1612, catheter 1620, magnetic capsule 1622, puncture catheter 1640, puncture tip 1642, delivery catheter 1650, and implantable device 1652.
  • Puncture catheter 1640 is substantially similar to puncture catheter 1630, but is sized to accommodate delivery catheter 1650 and implantable device 1652.
  • Delivery catheter 1652 is a length of catheter (a flexible shaft, tube, etc.) that can be used to advance implantable device 1652 to the location of a tissue shunt created by puncture catheter 1640 and to deploy implantable device 1652 in the shunt.
  • Implantable device 1652 can be any suitable implantable device and can be deployed in any suitable manner, as described previously with respect to implantable device 1364 (FIG. 28).
  • Puncture tip 1642 is a hollow, cylindrical needle having an inner surface that defines a lumen and an opening in a distal end of puncture tip 1642. Puncture tip 1642 is sized to allow implantable device 1652 to be advanced through puncture tip 1642 and into a shunt created using puncture tip 1642 through the opening in the distal end of puncture tip 1642. Puncture tip 1642 can, in some examples, be referred to as a “punch” or “tissue punch.” Delivery catheter 1650 can be used to advance implantable device 1652 through the inner lumen of puncture catheter 1640 and through puncture tip 1642 to deploy implantable device 1652 at a shunt formed by puncture tip 1642.
  • method 1500 can omit steps 1512-1518 and implantable device 1652 can be immediately implanted in the shunt formed by puncture tip 1642.
  • puncture tip 1642 is depicted in FIG. 31 as a hollow needle, in other examples, puncture tip 1642 can be any other suitable type of hollow cutting tool.
  • puncture tip 1642 can be a hollow tube with a distal RF-conducting edge.
  • any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (c.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).
  • the treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.
  • the devices, systems, and methods disclosed herein have been discussed generally with reference to formation of tissue openings through a single tissue wall, in other examples, the devices, systems, and methods disclosed herein can be adapted to form tissue openings and, accordingly, install shunt devices, form patent shunts, etc. through multiple tissue walls.
  • a boundary between two lumens within a heart or another portion of a patient cardiovascular system may be formed by two or more adjacent tissue walls.
  • the devices, systems, and methods can be adapted to form tissue openings through all relevant adjacent tissue walls. Shunt devices can then be installed and/or patent shunts formed through the tissue walls containing the tissue openings, thereby fluidly connecting the tissue lumens.
  • a device for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient including an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular body and the nosecone, and at least one electrocautery wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current, wherein the device is configured to be inserted through an opening in the tissue wall, wherein the elongate tubular body is retractable away from the nosecone to expose the at least one electrocautery wire, and wherein the at least one clcctrocautcry wire is rotatable to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • the device of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations and/or additional components or steps:
  • the at least one electrocautery wire includes a plurality of electrocautery wires; wherein the multi-lumen shaft includes a plurality of electrocautery wire lumens and a guidewire lumen; and wherein each individual wire of the plurality of electrocautery wires extends through a respective lumen of the plurality of electrocautery wire lumens and the guidewire extends through the guidewire lumen.
  • each individual wire of the plurality of electrocautery wires is spaced circumferentially about the multi-lumen shaft such that each individual wire of the plurality of electrocautery wires is configured to create a corresponding portion of the circumferential cut when the plurality of electrocautery wires is rotated.
  • a device as set forth above, wherein the plurality of electrocautery wires includes at least two electrocautery wires, and the at least two electrocautery wires are circumferentially spaced 180 degrees or less apart.
  • the multi-lumen shaft includes a plurality of clcctrocautcry wire lumens and a guidewire lumen, and wherein the at least one clcctrocautcry wire is configured to extend through any one of the plurality of electrocautery wire lumens and the guide wire extends through the guide wire lumen.
  • each of the plurality of electrocautery wire lumens is located at a different radial distance within the multi-lumen shaft from a central longitudinal axis of the multi-lumen shaft.
  • the elongate tubular body further includes a capsule that surrounds the multi-lumen shaft and forms an exterior surface of the elongate tubular body.
  • the elongate tubular body further includes a capsule that forms an exterior surface of the elongate tubular body.
  • the at least one electrocautery wire includes a plurality of electrocautery wires; and wherein each individual wire of the plurality of electrocautery wires is spaced circumferentially about the elongate tubular body such that each individual wire of the plurality of electrocautery wires is configured to create a corresponding portion of the circumferential cut when the plurality of electrocautery wires is rotated.
  • circumferential cut is a partial circumferential cut that is configured to form a foldable tissue flap that remains connected to the tissue wall adjacent the patent shunt.
  • the at least one integrated pressure sensor includes a plurality of integrated pressure sensors, wherein a first integrated pressure sensor of the plurality of integrated pressure sensors is connected to the nosecone, and wherein a second integrated pressure sensor of the plurality of integrated pressure sensors is connected to the elongate tubular body.
  • patent shunt is configured to shunt fluid between anatomically adjacent chambers or vessels of the cardiovascular system of the patient along a pressure gradient from a relatively higher-pressure chamber or vessel to a relatively lower- pressure chamber or vessel.
  • a system for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes a shunting device and at least one independent pressure sensor that is configured to be positioned proximal to, distal to, and/or adjacent to the shunting device within the cardiovascular system of the patient during a shunt formation procedure for the patient.
  • the shunting device includes an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular' body and the nosecone, and at least one electrocautery wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current, wherein the shunting device is configured to be inserted through an opening in the tissue wall, wherein the elongate tubular body is retractable away from the nosecone to expose the at least one electrocautery wire, and wherein the at least one electrocautery wire is rotatable to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • the system of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations and/or additional components or steps:
  • the multi-lumen shaft includes a plurality of electrocautery wire lumens and a guidewire lumen; and wherein the at least one electrocautery wire is configured to extend through any one of the plurality of electrocautery wire lumens and the guide wire extends through the guide wire lumen.
  • each of the plurality of electrocautery wire lumens is located at a different radial distance within the multi-lumen shaft.
  • the at least one independent pressure sensor is configured to be anchored to the tissue wall proximal to, distal to, and/or adjacent to the opening in the tissue wall on a first side or a second side of the tissue wall.
  • the at least one independent pressure sensor includes a plurality of independent pressure sensors; wherein a first independent pressure sensor of the plurality of independent pressure sensors is configured to be positioned on a first side of the tissue wall; and wherein a second independent pressure sensor of the plurality of independent pressure sensors is configured to be positioned on a second side of the tissue wall.
  • a system for forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes a first catheter configured to be inserted along a first side of the tissue wall, the first catheter including a first magnet configured to face the first side of the tissue wall when the first catheter is inserted along the first side of the tissue wall and including a wire passage therethrough and an extrudable wire, and a second catheter configured to be inserted along a second side of the tissue wall opposite the first side of the tissue wall, the second catheter including a second magnet configured to face the second side of the tissue wall when the second catheter is inserted along the second side of the tissue wall and including a wire receiver therein, wherein the first magnet and the second magnet are configured to be aligned across the tissue wall when the first catheter and the second catheter are inserted along respective sides of the tissue wall, wherein the extrudable wire is configured to be advanced through the first catheter and extruded through the wire passage in the first magnet to cut through the tissue wall and be captured in the wire receiver of the second magnet,
  • each of the wire passage through the first magnet and the wire receiver in the second magnet include an insulation layer.
  • the extrudable wire is rotatable to create a circumferential cut in the tissue wall, the circumferential cut forming the patent shunt through the tissue wall.
  • patent shunt is configured to shunt fluid between anatomically adjacent chambers or vessels of the cardiovascular system of the patient along a pressure gradient from a relatively higher-pressure chamber or vessel to a relatively lower- pressure chamber or vessel.
  • a method of forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes creating an opening in the tissue wall, advancing a shunting device partially through the opening in the tissue wall, the shunting device including an elongate tubular body, a nosecone adjacent a distal portion of the elongate tubular body, a guidewire extending longitudinally through the elongate tubular body and the nosecone, and at least one electrocautery wire extending longitudinally through the elongate tubular body and configured to conduct an electrical current, wherein the nosecone and the distal portion of the elongate tubular body are advanced through the opening in the tissue wall, retracting the elongate tubular body away from the nosecone to expose the at least one electrocautery wire, and rotating the at least one electrocautery wire to create a circumferential cut in the tissue wall, the circumferential cut forming a patent shunt through the tissue wall.
  • a method of forming an implantless shunt through a tissue wall of a cardiovascular system of a patient includes inserting a first catheter along a first side of the tissue wall, the first catheter including a first magnet configured to face the first side of the tissue wall when the first catheter is inserted along the first side of the tissue wall and including a wire passage therethrough and an extrudable wire, inserting a second catheter along a second side of the tissue wall opposite the first side of the tissue wall, the second catheter including a second magnet configured to face the second side of the tissue wall when the second catheter is inserted along the second side of the tissue wall and including a wire receiver therein, aligning the first magnet and the second magnet across the tissue wall when the first catheter and the second catheter are inserted along respective sides of the tissue wall, extruding the extrudable wire through the wire passage in the first magnet, cutting through the tissue wall with the extrudable wire to form a patent shunt through the tissue wall, and capturing the extrudable wire in the wire receiver of the second magnet after
  • a method of forming a shunt in a tissue wall between a left atrium and a coronary sinus includes advancing a first guide wire into the coronary sinus, advancing a second guide wire into the left atrium, advancing a first catheter into the coronary sinus over the first guide wire, wherein the first catheter includes a magnetic attractor at a distal end, advancing a second catheter into the left atrium over the second guide wire, wherein the second catheter includes a magnetic capsule at a distal end, aligning the magnetic attractor on the first catheter with the magnetic capsule on the second catheter via magnetic attraction therebetween, advancing a puncture catheter through a lumen of the second catheter, and puncturing the tissue wall with a puncture tip of the puncture catheter to form the shunt between the left atrium and the coronary sinus.
  • a method as set forth above, wherein pushing the magnetic attractor away from the tissue wall with the puncture tip comprises applying a force to a surface of the magnetic attractor using the puncture tip.
  • a method as set forth above, wherein pushing the magnetic attractor away from the tissue wall comprises pressing the magnetic attractor into a wall of the coronary sinus opposite the shunt.
  • a method as set forth above, wherein cauterizing the shunt comprises clcctrocautcrization of the shunt.
  • a system for forming an opening in a tissue wall includes an elongate tubular body and an electrocautery wire supported by the elongate tubular body.
  • the electrocautery wire is maneuverable for forming an opening in the tissue wall.
  • the tubular body may be actuated for maneuvering the electrocautery wire in a path that forms an opening.
  • electrocautery wire is offset with respect to a longitudinal axis of the elongate tubular body. Due to the offset position of the wire, rotation of the tubular body may cause the wire to move in a substantially circular path, which facilitates the formation of an opening.
  • the electrocautery wire preferably extends through a lumen in the elongate tubular body; however, it may also be positioned along an exterior.
  • a system as set forth above further comprising a nosecone positioned along a distal portion of the elongate tubular body, wherein a distal end of the electrocautery wire is secured to the nosecone.
  • rotation or other movement of the nosecone may be used to maneuver the wire for cutting through tissue.
  • the system may also be provided with a pull wire to actuate bending, which facilitates advancement through tortuous vasculature and/or precise positioning of the wire for cutting.
  • the tubular body may have a central lumen for receiving the guidewire.
  • the tubular body may also include a second offset lumen for receiving the clcctrocautcry wire.
  • tubular body is retractable for exposing at least a portion of the electrocautery wire at the treatment site.

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Abstract

Un dispositif permettant de former une ouverture à travers une paroi tissulaire du système cardiovasculaire d'un patient comprend un corps tubulaire allongé, une coiffe adjacente à une partie distale du corps tubulaire allongé, un fil-guide s'étendant longitudinalement à travers le corps tubulaire allongé et la coiffe, et au moins un fil d'électrocautérisation s'étendant longitudinalement à travers le corps tubulaire allongé et conçu pour conduire un courant électrique. Le dispositif est conçu pour être inséré à travers une ouverture dans la paroi tissulaire. Le corps tubulaire allongé est rétractable par rapport à la coiffe pour exposer le fil d'électrocautérisation. Le fil d'électrocautérisation peut entrer en rotation pour créer une découpe circonférentielle dans la paroi de tissu, la découpe circonférentielle formant un shunt à travers la paroi de tissu, lequel fait l'objet de la divulgation.
PCT/US2025/027374 2024-05-03 2025-05-01 Shuntage sans implant Pending WO2025231292A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463642159P 2024-05-03 2024-05-03
US63/642,159 2024-05-03

Publications (1)

Publication Number Publication Date
WO2025231292A1 true WO2025231292A1 (fr) 2025-11-06

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/027374 Pending WO2025231292A1 (fr) 2024-05-03 2025-05-01 Shuntage sans implant

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WO (1) WO2025231292A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190374254A1 (en) * 2017-02-10 2019-12-12 Texas Medical Center Transcatheter device for interatrial anastomosis
US20210077186A1 (en) * 2019-09-13 2021-03-18 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US20230099410A1 (en) * 2021-09-29 2023-03-30 Medtronic Vascular, Inc. Left-atrium-to-coronary-sinus shunt
US20240122645A1 (en) * 2021-07-09 2024-04-18 Terumo Kabushiki Kaisha Medical device and method for forming shunt

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190374254A1 (en) * 2017-02-10 2019-12-12 Texas Medical Center Transcatheter device for interatrial anastomosis
US20210077186A1 (en) * 2019-09-13 2021-03-18 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US20240122645A1 (en) * 2021-07-09 2024-04-18 Terumo Kabushiki Kaisha Medical device and method for forming shunt
US20230099410A1 (en) * 2021-09-29 2023-03-30 Medtronic Vascular, Inc. Left-atrium-to-coronary-sinus shunt

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