DE102017125600A1 - Controllable interatrial catheter-assisted temporary right-left shunt to relieve the right ventricle - Google Patents

Abstract

The invention relates to a controllable and / or regulatable interatrial catheter-assisted right-left shunt for relieving the right ventricle, comprising: a connection channel (301), at least two sensors (407, 408) and at least one volume-variable balloon / cylinder ( 404), which can be positioned in the connecting channel (301) with respective actuator for volume change, wherein the shunt can be connected to a control and / or evaluation and / or control unit and receives the signals of the respective sensors, processed and in response to a Evaluation of the signals the respective volume of the balloon / cylinder (404) via the respective actuator controls and / or regulated.

Description

The device shown in this description relates to the field of medical technology.

The invention relates to a controllable and / or regulatable interatrial catheter-based right-left shunt for relieving the right ventricle or a controllable interatrial catheter-based temporary right-left shunt for relieving the right ventricle.

The right ventricle is one of the ventricles responsible for the flow of deoxygenated blood through the lungs and is inherently thin-walled and therefore prone to insufficiency more rapidly than the left ventricle, usually as a result of pulmonary arterial hypertension which, for its part, occurs either because of chronic obstructive pulmonary disease or diseases of the left heart.

For this reason, especially in the context of cardiac surgery, the possibility of temporarily relieving the right ventricle in the early postoperative recovery phase by means of a temporary right-left shunt is of great importance. This facilitates and accelerates the exit from the heart-lung machine, reduces the catecholamine requirement for circulatory support, increases the stroke and thereby the cardiac output, lowers the risk of open thorax and allows ECMO therapy (extracorporeal membrane oxygenation) to be avoided.

To date, only two transatrial shunt systems have appeared on the market, and patients have already been implanted in clinical trials, namely V-Wave Shunt, VWave, Or Akiva, Israel and IASD (InterAtrial Shunt Device) and Corvia Medical, Tewkesbury, MA, USA according to the document US 2013/0178783 A1 , where both shunts are left-right atrial and used for the treatment of left ventricular heart failure.

V-Wave Device is a unidirectional, interantial shunt implanted into the atrial septum in catheter technology, which lowers the pressure in the left atrium by the unilateral flow from left to right as the pressure gradient between the two atria exceeds 5 mmHg ( Amat-Santos IJ, Bergeron S, Bernier M, et al. Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. 2015 euro intervention 10 (9): 1 127-31. doi: 10.4244 / EIJY14M05_07 ). This shunt is indicated for patients with both left ventricular pumping function (diastolic heart failure) and restricted pump function (systolic heart failure). This implant prevents pulmonary congestion, reduces the rate of readmissions, improves the symptoms of heart failure and improves the quality of life. The device consists of an hourglass-type nitinol framework with a coating of polytetrafluoroethylene on the left side and three sails made of beef pericardium on the right side to prevent paradoxical embolization and the former occlusion of the shunt ( Amat-Santos IJ, Nombela-Franco L, Garcia B, Tobar J, Rodes-Cabau J, San Roman JA. The V-Wave device for the treatment of heart failure Initial experience in Europe. 2015 Rev Esp Cardiol. 68: 808-10 - Vol. 68 N.9. doi: 10.1016 / j.rec. 2015.04.015 ). First implantations were performed on ten patients in Canada between 2013 and 2015 ( Del Trigo M et al. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. The Lancet, Volume 387, Issue 10025, 1290-1297 ). V-Wave Shunt is currently approved in clinical trials in Europe and is not yet approved in the US.

InterAtrial ShuntDevice (IASD) is the world's first catheter-assisted heart failure device that is currently being tested in Europe but is not yet officially approved for routine implantation. This is made of Nitinol and has a 19 mm outer diameter. After implantation in the atrial septum it permanently keeps a new 8 mm connection between left and right atrium open after its unfolding ( Søndergaard L, Reddy V, Kaye D et al. Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Interatrial Implant to Lower Left Atrial Pressure. 2014 Eur J Heart Failure 16: 796-801. doi: 10.1002 / ejhf.111 ). The device is indicated for patients with diastolic heart failure. REDUCE LAP-HF 1 is a multi-center, open-label, single-arm study in which over 40% of 68 patients older than 40 years old with LVEF (left ventricular ejection fraction) have demonstrated that IASD implantation is safe and also significantly reduces left atrial pressure under exercise ( Hasenfuß G, Hayward C, Burkhoff D et al. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. 2016 Lancet 387 (10025): 1298-304. doi: 10.1016 / S0140-6736 (16) 00704-2) ,

Other publications on the IASD in the prior art are listed below, namely Kaye D, Hasenfuß G, Neuzil P, et al. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. 2016 Circ Heart Fail. 9 (12). pii: e003662 , Malek F, Neuzil P, Gustafsson F et al. Clinical Outcome of Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Implant. 2015 International Journal of Cardiology 187: 227-28. doi: 10.1016 / j.ijcard. 2015.03.198 such as Hasenfuss G, Gustafsson F, Kaye D et al. Rational and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failures (Reduce LAP-HF) Trial. 2015 J Card Fail 21 (7): 594-600. doi: 10.1016 / j.cardfail.2015.05.008 , Kaye D, Shah S, Borlaug B et al. Effects of an Interatrial Shunt on Rest and Exercise Hemodynamics: Results of a Computer Simulation in Heart Failure. 2014 Journal of Cardiac Failure 20 (3): 212-21. doi: 10.1016 / j.cardfail.2014.01.005 ,

These two systems are being designed to treat systolic / diastolic left ventricular heart failure by lowering the left atrial blood pressure via the shunt, are permanent and therefore non-surgically removable, and are considered an interventional treatment option for patients with depleted reserves of drug therapy. Relief of heart failure symptoms is dependent on shunt size. This means that, on the one hand, too large a shuntostium leads to an increased outflow of oxygen-poor blood to the left and it can cause not only a volume load on the left ventricle and a decompensation of its pumping function, but also a decrease of the saturation values. On the other hand, too little ostium levels the hemodynamic effect of this shunt and its clinical benefits can not fully develop. In this way, the controllability of such systems plays an important role. Controllability is the gradual development of the shunt under precise and continuous echocardiographic control of flow across the shunt and its adjustment as a function of patient demand.

A Temporary Shunt is not intended for the long-term treatment of chronic right ventricular failure, but for temporary relief of the right ventricle after cardiac surgery, and especially if persistent tricuspid valve regurgitation has been resolved, and may be an alternative to ECMO therapy with sustained left ventricular pumping function. Short-term use reduces the risk of septic complications and thromboembolism.

The present invention has for its object to provide a medical device for the reduction of the right atrial and thus the right ventricular pressure in patients with limited right ventricular pumping function.

This problem is solved with a medical shunt arrangement according to the main claim.

• - einen Verbindungskanal,
• - wenigstens zwei Sensoren

und

• - wenigstens einen bezüglich des Volumens veränderbaren Ballon/Zylinder, der im Verbindungskanal positionierbar ist mit jeweiligem Aktor zur Volumenänderung,

wobei der Shunt mit einer Regel- und/oder Auswerte- und/oder Steuereinheit verbindbar ist und diese die Signale der jeweiligen Sensoren empfängt, verarbeitet und in Abhängigkeit von einer Auswertung der Signale das jeweilige Volumen des Ballons/Zylinders über den jeweiligen Aktor ansteuert und/oder regelt.The controllable and / or regulatable interatrial catheter-based right-left shunt according to the invention for relieving the right ventricle has:

• a connection channel,
• - at least two sensors

and

• at least one volume-variable balloon / cylinder, which is positionable in the connecting channel with respective actuator for volume change,

wherein the shunt is connectable to a control and / or evaluation and / or control unit and receives the signals of the respective sensors, processes and, depending on an evaluation of the signals, activates the respective volume of the balloon / cylinder via the respective actuator and / or regulates.

Furthermore, in a particular embodiment variant, at least one sensor can be positioned in the region of a first distal end of the connection channel and at least one further sensor can be positioned in the region of a second distal end, wherein a respective pressure or pressure difference and / or a respective flow (velocity) or velocity Flow (speed) difference is detectable.

Furthermore, the connecting channel can have positioning means and / or fixing means at its distal ends.

In particular, this shunt is intended for temporary use or application.

This device is designed to reduce right atrial and thus right ventricular pressure in patients with impaired right ventricular pumping function in the first few days after cardiac surgery. It is particularly important for patients undergoing reconstruction of the tricuspid valve, because it deprives the right ventricle of the opportunity to relieve itself through the return current at its original leakage into the right atrium.

The reduction of the right atrial pressure is done by placing the shunt after the atrial septum puncture either under fluoroscopic control before surgery and thoracotomy or after starting the heart-lung machine and the opening of the right atrium now under visual control.

First, the catheter is inserted through the puncture of one of the central venous cervical vessels (internal jugular vein or subclavian vein) with a puncture needle. Through this needle is in Seldinger technique placed a guidewire in the right atrium. Furthermore, the puncture needle is removed and via this wire a venous loop is applied and fixed to the skin. Subsequently, a pigtail catheter is demonstrated over the same wire in the right atrium and performed angiogram with representation of the right atrium. Then, the pigtail catheter is swapped with a Brosebrough transseptal catheter with a needle for atrial septal puncture in the area of the fossa ovalis. The pressure in the right and left atrium is continuously measured and observed. After passing through the septum, the Brockenbrough septum puncture needle is removed and a guidewire advanced through this catheter into the left atrium. Next, using the X-ray positive markers, the placement of the shunt catheter occurs exactly in the middle of the atrial septum. Thereafter, the external balloon of the shunt is inflated with contrast agent solution until it fully unfolds and is firmly fixed by the dumbbell-shaped shape on both sides of the atrial septum. This balloon contains a cavity along its entire length that forms a connecting channel (shunt) between the right and left atrium. Then, under echocardiographic control, one port will also fill the internal balloon in the shunt channel with contrast medium solution. This adjusts the flow across the shunt as a function of arterial saturation, pumping function and volume load of the left ventricle, and relief of the right ventricle until the therapeutic effect of the shunt is reached. At the shunt, detectors are mounted to measure the right atrial and left atrial pressures and flow across the shunt.

• - schnelle Implantation sowohl interventionell als auch im Rahmen eines offenen herzchirurgischen Eingriffs;
• - Shuntvolumen kann nach Patientenbedarf adjustiert werden;
• - das System ist kosteneffektiv;
• - das System kann prinzipiell auch als links-rechts Shunt angewendet werden;
• - das System ist vollständig einwandfrei, genauso wie alle zentralvenösen Katheter, durchs Entleeren der beiden Ballons und Zug entfernbar.

Advantages of this device or method are:

• - rapid implantation both interventionally and in the context of an open cardiac surgery;
• - Shunt volume can be adjusted according to patient needs;
• - the system is cost effective;
• - The system can be used in principle as a left-right shunt;
• - The system is completely flawless, as are all central venous catheters, by draining the two balloons and pulling removable.

The risks of this method could be:

Cardiac arrhythmia, bleeding, injury to the heart cavities, thrombosis, embolism, stroke, pulmonary embolism, worsening heart failure, catheter infection, endocarditis / sepsis, dislocation of the shunt, persistent shunt after device removal, balloon rupture with loss of its parts in the circulation, cardiac arrest, pulmonary congestion, pneumonia, renal insufficiency , Rethoracotomy, Pneumothorax and Death.

Hereinafter, embodiments of the invention will be described in detail with reference to the accompanying drawings in the description of the figures, which are intended to illustrate the invention and are not to be considered as limiting:

• die abgeschlossene Punktion des Vorhofseptums mit einem Brockenbrough-Katheter und einer Brockenbrough-Nadel;
• ein durch die venöse Schleuse anhand eines Führungsdrahtes im Vorhofseptum positionierter shunttragender Katheter;
• eine schematische Darstellung eines Ausführungsbeispiels des Shunts;
• eine schematische Darstellung eines Ausführungsbeispiels des Shunts im Längsschnitt;
• eine schematische Darstellung eines Ausführungsbeispiels des Shunts im Querschnitt;
• eine schematische Darstellung eines weiteren Ausführungsbeispiels des Shunts im Querschnitt und
• eine schematische Darstellung eines dritten Ausführungsbeispiels des Shunts im Querschnitt.

Show it:

• the completed atrial septal puncture with a Brockenbrough catheter and a Brockenbrough needle;
• a shunt-carrying catheter positioned through the venous sheath based on a guidewire in the atrial septum;
• a schematic representation of an embodiment of the shunt;
• a schematic representation of an embodiment of the shunt in longitudinal section;
• a schematic representation of an embodiment of the shunt in cross section;
• a schematic representation of another embodiment of the shunt in cross section and
• a schematic representation of a third embodiment of the shunt in cross section.

On becomes the completed puncture of the atrial septum with a Brockenbrough catheter 102 and a Brockenbrough needle 103 shown. The catheter is through a venous lock 101-1 / 101-2 under fluoroscopy and positioned in the area of the fossa ovalis of the atrial septum.

On gets through the venous lock 101-1 / 101-2 using a guidewire 201 Shunt-carrying catheter positioned in the atrial septum 205 shown. At the proximal part of this catheter 202 / 203 / 204 / 209 There are a total of five ports: Port 209 is intended for the introduction of the wire, port 204 is intended for connection of the pressure measurement in the right and left atrium, port 210 is intended for connecting the flow measurement via the shunt, port 203 is intended for application of the contrast agent solution in the outer balloon of the shunt, port 202 is intended for application of the contrast agent solution in the inner balloon of the shunt. At the distal part of the catheter 206 / 207 / 208 is the shunt device with three markers, which are intended for the correct placement of the shunt in the atrial septum: mark 208 corresponds to the right atrial part of the shunt, mark 206 corresponds to the left atrial part of the shunt, mark 207 corresponds to the middle (septal) part of the shunt.

shows the shunt. This shunt consists of an outer balloon 302 / 303 / 304 and an inner balloon (not shown on this illustration, p. . . . ). The outer balloon gets through the port 203 of the shunt catheter 205 filled with contrast medium solution until it is fully unfolded, it takes the form of a dumbbell whose external parts are in the right 303 and left 302 atria, which excludes the shunt dislocation and thus this balloon is attached in the atrial septum. The outer balloon has a middle part 304 in which a cave has a connecting channel 301 (Shunt) forms between right and left atrium. The middle part 304 spreads the puncture channel in the atrial septum after its full deployment and thus creates the pressure for even better attachment of the whole system. After the final placement of the shunt, the guidewire can 201 be removed.

On the shunt is shown in longitudinal section. Under 409 detectors are recorded for continuous flow measurement over the stunt. Under 407 and 408 Pressure detectors are recorded in the right or left atrium. The outer balloon is filled with a solution over the canal 401 filled to completion. Under 402 is the confluence of the canal 401 recorded in the outer balloon. The inner balloon 404 It serves to adjust the shunt lumen and thereby regulates the flow across the shunt, from a complete occlusion of the shunt to its full opening according to patient needs. Radiography and echocardiography are used to control the shunt position. In addition, the effectiveness of the therapy is adjusted and assessed by means of the pressure and flow measurement. The inner balloon 404 comes with the solution over the channel 403 refilled. Under 405 is the confluence of the canal 403 recorded.

On the shunt is shown in cross section. The inner balloon can be constructed in three modifications. The first modification is a cylinder 404 , which is implanted within the outer balloon and after application of the solution unfolds and thereby changes the diameter of the shunt lumen 301 , The advantage of this construction is the physiological blood flow through the shunt. Under 501 and 502 the cables are recorded to the pressure or flow detectors.

On becomes the shunt in cross-section with the second modification of the inner balloon 404 shown. In this modification, the inner balloon is located on the lower wall of the outer balloon and shaped as a sphere which, when deployed, forms the lumen of the shunt 301 reduced (recorded with dotted lines). However, this construction has less physiological flow than that on the is recorded.

shows the shunt in cross-section with the third modification of the inner balloon 404 shown. This balloon consists of two hemispheric parts that unfold simultaneously when inflated and thus the diameter of the shunt lumen 301 to reduce.

LIST OF REFERENCE NUMBERS

101-1

venous lock

101-2

venous lock

102

Brockenbrough catheter

103

Brockenbrough needle

201

guidewire

202

port

203

port

204

port

205

catheter

206

mark

207

mark

208

mark

209

port

210

port

301

connecting channel

302

left atrium

303

right atrial

304

middle part

401

channel

402

Einmündungsostium

403

channel

404

inner balloon / cylinder

405

Einmündungsostium

407

pressure detector

408

pressure detector

409

detectors

501

electric wire

502

electric wire

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 2013/0178783 A1 [0005]

Cited non-patent literature

• Amat-Santos IJ, Bergeron S, Bernier M, et al. Left atrial decompression through unidirectional left-to-right interatrial shunt for the treatment of left heart failure: first-in-man experience with the V-Wave device. 2015 euro intervention 10 (9): 1 127-31. doi: 10.4244 / EIJY14M05_07 [0006]
• Amat-Santos IJ, Nombela-Franco L, Garcia B, Tobar J, Rodes-Cabau J, San Roman JA. The V-Wave device for the treatment of heart failure Initial experience in Europe. 2015 Rev Esp Cardiol. 68: 808-10 - Vol. 68 N.9. doi: 10.1016 / j.rec. 2015.04.015 [0006]
• Del Trigo M et al. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. The Lancet, Volume 387, Issue 10025, 1290-1297 [0006]
• Søndergaard L, Reddy V, Kaye D et al. Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Interatrial Implant to Lower Left Atrial Pressure. 2014 Eur J Heart Failure 16: 796-801. doi: 10.1002 / ejhf.111 [0007]
• Hasenfuß G, Hayward C, Burkhoff D et al. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. 2016 Lancet 387 (10025): 1298-304. doi: 10.1016 / S0140-6736 (16) 00704-2) [0007]
• Kaye D, Hasenfuß G, Neuzil P, et al. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. 2016 Circ Heart Fail. 9 (12). pii: e003662 [0008]
• Malek F, Neuzil P, Gustafsson F et al. Clinical Outcome of Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Implant. 2015 International Journal of Cardiology 187: 227-28. doi: 10.1016 / j.ijcard. 2015.03.198 [0008]
• Hasenfuss G, Gustafsson F, Kaye D et al. Rational and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failures (Reduce LAP-HF) Trial. 2015 J Card Fail 21 (7): 594-600. doi: 10.1016 / j.cardfail.2015.05.008 [0008]
• Kaye D, Shah S, Borlaug B et al. Effects of an Interatrial Shunt on Rest and Exercise Hemodynamics: Results of a Computer Simulation in Heart Failure. 2014 Journal of Cardiac Failure 20 (3): 212-21. doi: 10.1016 / j.cardfail.2014.01.005 [0008]

Claims (3)

Controllable and / or adjustable interatrial catheter-based right-left shunt for relief of the right ventricle with: a connection channel (301), - At least two sensors (407, 408) and - At least one with respect to the volume variable balloon / cylinder (404), which is positionable in the connecting channel (301) with respective actuator for volume change, the shunt with a control and / or evaluation and / or control unit is connected and these signals receives the respective sensors, processes and depending on an evaluation of the signals the respective volume of the balloon / cylinder (404) via the respective actuator controls and / or regulates. Shunt after Claim 1 , characterized in that at least one sensor (407, 409) in the region of a first distal end of the connecting channel (301) is positionable and at least one further sensor (408, 409) can be positioned in the region of a second distal end, wherein a respective pressure or Pressure difference and / or a respective flow (speed) or flow (speed) difference can be detected. Shunt after one of the Claims 1 or 2 , characterized in that the connecting channel (301) has at its distal ends positioning means and / or fixing means.

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