JPWO2020251999A5

JPWO2020251999A5 -

Info

Publication number: JPWO2020251999A5
Application number: JP2021573542A
Authority: JP
Publication date: 2023-03-29
Anticipated expiration: 2040-06-10

Claims

A transseptal insertion device suitable for facilitating accurate and safe transseptal puncture of the cardiac atrial septum, comprising:
A sheath having a distal end positioned toward the cardiac atrial septum of a patient and a proximal end external to the patient when the transseptal device is in use, said sheath a sheath comprising at least one lumen extending between the proximal end and the distal end of
at least one positioning balloon extending radially outwardly from the sheath adjacent the distal end of the sheath and movable from an inflated position to a deflated position; to prevent accidental puncture of the cardiac atrial septum and stabilize the transseptal insertion device against the fossa ovalis of the cardiac atrial septum. one positioning balloon;
a barb extending longitudinally within the at least one lumen of the sheath , the barb having a distal end;
a piercing balloon extending radially outwardly from the piercing adjacent the distal end of the piercing ;
including
The sheath includes at least one deflation port positioned adjacent the at least one positioning balloon , the at least one deflation port connecting the at least one lumen of the sheath and the at least one positioning balloon. providing fluid communication between the balloons, the at least one deflation port deflating the at least one positioning balloon when the at least one positioning balloon is moved from the inflated position to the deflated position, and the piercing portion The distal end of the barb extends distally from the distal end of the sheath from a retracted position in which the distal end of the barb is located within the at least one lumen of the sheath. movable to an operative position, the piercing portion including a port and a lumen, wherein the lumen of the piercing portion and the port are in fluid communication to provide fluid communication between the lumen of the piercing portion and the piercing balloon; wherein said piercing balloon is movable from a deflated position to an inflated position, wherein in said inflated position said piercing balloon is in said at least one deflation port of said sheath when said piercing is in said retracted position; when positioned adjacent to seal the at least one deflation port of the sheath, the at least one positioning balloon being movable from the deflated position to the inflated position and the piercing portion being in the operative position; The pierce balloon is positioned distally from the at least one deflation port of the sheath to open the at least one deflation port of the sheath, and the at least one positioning balloon moves from the inflated position to the deflated position. A transseptal insertion device, characterized in that it is capable of :

2. The transseptal insertion device of Claim 1, wherein the sheath includes at least one inflation port for inflating the at least one positioning balloon.

wherein the sheath includes at least one hypotube connected to the at least one inflation port of the sheath, and the at least one positioning balloon is provided with flow delivered through the at least one hypotube. 3. The transseptal insertion device of claim 2 , wherein the device is inflated by the body.

3. The transseptal insertion device of claim 2 , wherein the at least one deflation port of the sheath is positioned distally to the at least one inflation port of the sheath.

the piercing includes a lumen extending from the distal end to the proximal end of the piercing and a transseptal wire disposed within the lumen of the piercing; 2. The transseptal insertion device of claim 1, wherein a septal wire has a distal end configured to accurately pierce the cardiac atrial septum .

2. The transseptal of Claim 1, wherein the piercing portion includes a radio frequency (RF) tip at the distal end of the piercing portion, the RF tip configured to transmit radio frequency energy. insertion device.

7. The transseptal insertion device of Claim 6 , wherein said piercing portion includes a radio frequency generator that produces radio frequency energy that is transmitted to said radio frequency tip.

2. The method of claim 1, further comprising at least one ultrasound transceiver on a surface of said at least one positioning balloon for emitting and receiving ultrasound waves and converting said ultrasound waves into electrical signals. transseptal insertion device.

A method suitable for facilitating accurate and safe transseptal puncture of the cardiac atrial septum with a transseptal insertion device, said method comprising:
inflating a puncture balloon positioned over a puncture having a distal end positioned toward the patient's heart-atrial septum;
sealing one or more deflation ports disposed in the sheath with the inflated pierce balloon;
inflating one or more locating balloons connected to the distal end of the sheath, wherein the inflated one or more locating balloons extend out over the distal end of the sheath;
positioning the piercing portion against the fossa ovalis of the cardiac atrial septum while the one or more positioning balloons are inflated;
advancing the piercing portion toward the fossa ovalis such that the distal end of the piercing portion extends beyond the one or more flared positioning balloons; the balloon moves away from the one or more deflation ports;
deflating the one or more positioning balloons while the distal end of the piercing portion is pushing against the fossa ovalis;
A method comprising:

and advancing a transseptal wire beyond the distal end of the puncture to pierce the fossa ovalis, the transseptal wire within a central lumen formed in the puncture. 10. The method of claim 9 , wherein the method is arranged in a .

10. The method of claim 9 , wherein the piercing balloon is inflated by gas or fluid supplied through an inflation port located in the piercing.

10. The method of claim 9 , wherein the one or more positioning balloons are inflated by gas or fluid supplied through one or more inflation ports disposed on the sheath.

13. The method of claim 12 , wherein the one or more deflation ports of the sheath are located closer to the distal end of the sheath than the one or more inflation ports of the sheath.

10. The method of claim 9 , wherein the one or more positioning balloons are deflated through the one or more deflation ports of the sheath.

13. The method of claim 12 , wherein the one or more positioning balloons are deflated through both the one or more deflation ports of the sheath and the one or more inflation ports of the sheath.