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WO2021230830A1 - A dynamic flow controller for heart failure - Google Patents

A dynamic flow controller for heart failure Download PDF

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Publication number
WO2021230830A1
WO2021230830A1 PCT/TR2020/050415 TR2020050415W WO2021230830A1 WO 2021230830 A1 WO2021230830 A1 WO 2021230830A1 TR 2020050415 W TR2020050415 W TR 2020050415W WO 2021230830 A1 WO2021230830 A1 WO 2021230830A1
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WO
WIPO (PCT)
Prior art keywords
diameter
pressure
heart
heart failure
balloon
Prior art date
Application number
PCT/TR2020/050415
Other languages
French (fr)
Inventor
Mehmet Hakan Akpinar
Original Assignee
Mehmet Hakan Akpinar
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 Mehmet Hakan Akpinar filed Critical Mehmet Hakan Akpinar
Priority to PCT/TR2020/050415 priority Critical patent/WO2021230830A1/en
Publication of WO2021230830A1 publication Critical patent/WO2021230830A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623Introducing or retrieving devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/0215Measuring pressure in heart or blood vessels by means inserted into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852Catheters
    • A61B5/6853Catheters with a balloon

Definitions

  • the present invention relates to a heart failure dynamic flow controller device that is used to provide palliative care and/or therapy for heart failure patients.
  • Palliative care is specialized care that focuses on improving quality of life (QOL) through relief of stress and symptoms for patients with serious illness.
  • Palliative care is applicable for any patient in the advanced stages of illness, including patients with heart failure (HF).
  • HF patients not only suffer from dyspnea which is caused by increased left atrial pressure (LAP) and fatigue as a result of their disease process, but also have a high burden of somatic complaints, including pain, nausea, anxiety, and depression, leading to significant psychosocial distress for both patients and their caregivers.
  • LAP left atrial pressure
  • LAP monitoring is performed to obtain hemodynamic insight into left-sided cardiac structures.
  • LAP may provide value when there is a concern for LV function (systolic and diastolic), left atrial hypertension, or concern for LV preload (acute right heart failure, pulmonary hypertension).
  • Access to left atrial pressures can be acquired via the transthoracic route or the transseptal route.
  • Left atrial hypertension is a typical concern in patients with diminutive left-sided structures following a two-ventricle repair, mitral valve repair, and acutely following LV assist device placement.
  • Patients at risk for right heart failure or vulnerable to a pulmonary hypertensive crisis may benefit from LAP monitoring because an acute decrease in LAP can signify the loss of LV preload.
  • These patients with dynamic control of the preload of the LV can be treated for longer- term which will increase the survival time compared to the constant shunt diameter and cross-section devices which are proven to be palliative.
  • Balloon aortic valvuloplasty is also a viable option for patients who have advanced HF who are hemodynamically unstable or as a palliative approach when the effect is time-limited.
  • the InterAtrial Shunt Device (IASD®; Corvia Medical, Tewksbury, MA, USA) is the world's first transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity to lower left atrial pressure.
  • IASD® Corvia Medical, Tewksbury, MA, USA
  • HFpEF preserved
  • HFmrEF mid-range ejection fraction
  • the V-Wave device (V-Wave Ltd, Or Akiva, Israel) is based on this concept and on the experience of the creation of interatrial shunts to treat patients with congenital heart disease or ventricular assist devices.
  • the V-Wave device which permanently reduces left atrial pressure, is composed of an hourglass-shaped nitinol frame with a polytetrafluoroethylene polymer coating on its left side and a valve with 3 bovine pericardium leaflets on its right side to prevent paradoxical embolisms and early shunt closure.
  • the AFR device differs from these devices in several aspects. It has no incorporated valve tissue. Interatrial communication is large (8 mm). The AFR device is uncoated, made of nitinol mesh. A procedural difference is the necessity to perform a balloon atrial septostomy before AFR implantation, which was performed safely in all cases. Procedural success rate and patency of the device (confirmed by TEE post-procedure and at three-month follow-up) placement of an ASD closure device with a relatively short device during the procedure is low because it is fully retrievable up to final deployment. No stroke/TIA or thrombus on the device was observed at three months using TEE.
  • Figure 1 A schematic illustration of a preferred embodiment of the invention that is used as a dynamic flow controller in heart failure patients having three types as 1 a, 1 b and 1 c.
  • FIG. 2 A schematic illustration of a preferred embodiment of the invention having component details including shape memory alloy wires formed to create a fenestration with desired diameter, a pressure sensor located high-pressure side of the fenestrated shunt, a connecting hub of the device to the pusher cable, a stimulation device with an internal battery and software (detailed version of Fig. 1 c).
  • FIG. 3 A schematic illustration of a preferred embodiment of the invention with different diameters (D1 , D2, D3).
  • Figure 4 A schematic illustration of a preferred embodiment of the invention showing the change on the formed shape memory alloy with diameter expansion.
  • Figure 5 A schematic illustration of a preferred embodiment of the invention showing the dilatation balloon catheter for fenestration enlargement of the device.
  • Figure 6 A schematic illustration of a preferred embodiment of the invention having details including a glass shaped balloon for diameter decrease and marker bands showing the distance between the balloon inflated parts to calibrate the diameter of the device fenestration.
  • FIG. 7 A schematic illustration of a preferred embodiment of the delivery system of the invention having details including a pusher cable handle for rotating to screw on and off, a pusher cable main body, a loader for the device, a delivery sheath, a device connected to the pusher cable, and a connection part of the pusher cable to the device body.
  • pusher cable 108 loader 109: delivery sheath 110: pusher cable 111 : connection part of the pusher cable
  • Figure 1 a,1 b,1 c shows a device that is used to control and adjust the pressure and the amount of the blood volume between the adjacent sides of the device where it is implanted.
  • Figure 1 a shows a device that has a mechanical structure to change these properties with a balloon inflation catheter (105) and
  • Figure 1 b shows a device with a pressure sensor (102) and external energy transfer to change the dimensions of the device
  • Figure 1 c shows a device with a stimulation device (104) with an internal battery -externally chargeable- and software to sense the pressure, flow changes and adjust accordingly to stabilize the hemodynamic of the patient.
  • the embodiment consists of one or more wires (101 ) to form a certain diameter (D1 )in the central part of the device with a shape- memory alloy that is specially calculated and designed elastic and plastic deformation properties at the bending location and the diameter is expanded to a certain diameter by the balloon inflation catheter (105) or external energy transfer or a stimulation device (104) with internal battery and software which sense the pressure changes and transfer energy to change the diameter accordingly.
  • the invention has 3 versions: 1 a is a mechanical device that consists of only shape-memory alloy and it has special design angulation between the loops of the wires with enough force applied by the balloon inflation catheter (105) to cause plastic deformation at the bending area of the wires to change the fenestration from D1 to D2 and the distances between the discs from L1 to L2 and D2 to D3 and the distance from L2 to L3, respectively but the different nominal diameter of the balloon catheter for the desired diameter achievement.
  • the same principle is used to apply enough pressure from both sides of the device discs with a specially designed time-glass shaped balloon (112) which applies hydraulic pressure to both sides of the discs when inflated to a high pressure to decrease the length and enough force to create a plastic deformation on the bending from wires of the shape-memory alloy to decrease the D3 to D2, L3 to L2, D2 to D1 , L2 to L1 , respectively.
  • the 1 b device has a pressure sensor (102) sense the pressure changes and an external energy surge delivers energy need to deform the angulation at the bending points of the shape-memory alloy to expand the D1 to D2, D2 to D3, respectively and decrease of the diameter is done with time-glass shaped balloon (112) catheter mechanically.
  • the 1 c device has a pressure sensor (102) on the device and is connected to the stimulation device (104) with an internal battery which can be charged wireless from an external resource and a software stimulation the diameter changes according to the pressure changes obtained from the sensor element. This fully automated device can change the diameter to any diameter required while the first and second design can do it to the predetermined diameter steps.
  • the invention device has two discs on both sides of the chambers adjacent to the device and a connection waist which is specially formed wires that the length between the discs adjusting the diameter of fenestration with enough force applied to create a plastic deformation.
  • the device can be formed with or without a connecting hub (103) to the delivery cable, with or without a pressure sensor(102).
  • the invention device can be made with or without an external coating for preventing thrombus formation or sudden closure of the permanent shunt.
  • an introducer is placed according to the calibration of the delivery sheath (109) and a guidewire is advanced and a puncture is created at the desired location where the fenestration needed.
  • a balloon dilatation catheter (105) is applied to achieve blood flow between two chambers of the heart and the device without collapsing.
  • the device is loaded to the loader (108), connected to the pusher cable (110) with the connection part of the pusher cable (111 ) to the device body and pushed inside through a pusher cable handle (106) for rotating to screw on and off until it reaches to the implantation location and then the first disc of the device is formed on one side of the heart chamber while the waist in located inside the punctured tissue and the second disc is formed on the other side.
  • the device is released from the pusher cable (107) and a control angiogram is performed to observe the shunt with TEE or TTE.
  • the post dilatation can be done to achieve the exact diameter of the fenestration part.
  • the device can be post-dilated to a desired diameter with the same intervention case or later when needed from D1 to D2, D2 to D3 and can be decreased with a time-glass shaped balloon (112) to the desired diameter from D3 to D2, D2 to D1 , respectively.
  • the second version, 1b has a pressure sensor (102) to sense the pressure changes and the device fenestration will be adjusted accordingly either by a dilatation balloon catheter (105) for fenestration enlargement or time-glass shaped balloon (112) to decrease the diameter.
  • the third version of the device, 1c has a pressure sensor (102) to sense the pressure changes and adjust the fenestration diameter with a stimulation device (104) with an internal battery and software by delivering energy to the bending location of the shape-memory alloy to change the angulation to increase and decrease the central diameter of the fenestration.
  • the marker bands (113) shows the distance between the balloon inflated parts to calibrate the diameter of the device fenestration.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

The present invention relates to a heart failure dynamic flow controller device that is used to provide palliative care and/or therapy for heart failure patients.

Description

DESCRIPTION
A DYNAMIC FLOW CONTROLLER FOR HEART FAILURE
Technical Field Of The Invention
The present invention relates to a heart failure dynamic flow controller device that is used to provide palliative care and/or therapy for heart failure patients.
Background Of The Invention
Palliative care is specialized care that focuses on improving quality of life (QOL) through relief of stress and symptoms for patients with serious illness. Palliative care is applicable for any patient in the advanced stages of illness, including patients with heart failure (HF). HF patients not only suffer from dyspnea which is caused by increased left atrial pressure (LAP) and fatigue as a result of their disease process, but also have a high burden of somatic complaints, including pain, nausea, anxiety, and depression, leading to significant psychosocial distress for both patients and their caregivers.
Left atrial pressure (LAP) monitoring is performed to obtain hemodynamic insight into left-sided cardiac structures. LAP may provide value when there is a concern for LV function (systolic and diastolic), left atrial hypertension, or concern for LV preload (acute right heart failure, pulmonary hypertension). Access to left atrial pressures can be acquired via the transthoracic route or the transseptal route.
Left atrial hypertension is a typical concern in patients with diminutive left-sided structures following a two-ventricle repair, mitral valve repair, and acutely following LV assist device placement. Patients at risk for right heart failure or vulnerable to a pulmonary hypertensive crisis may benefit from LAP monitoring because an acute decrease in LAP can signify the loss of LV preload. These patients with dynamic control of the preload of the LV can be treated for longer- term which will increase the survival time compared to the constant shunt diameter and cross-section devices which are proven to be palliative. State Of The Art
Most treatment options for heart failure aim to relieve symptoms as a palliative care strategy. The medicines that are effective for treating some types of heart failure but they often do not work for the patients having heart failure with preserved ejection fraction.
Balloon aortic valvuloplasty (BAV) is also a viable option for patients who have advanced HF who are hemodynamically unstable or as a palliative approach when the effect is time-limited.
Reducing LAP and LA volume overload using an atrial septum shunt device has emerged as a novel treatment option to improve HF symptoms. Paitazoglou et al. (Paitazoglou C, Ozdemir R, Pfister R, Bergmann MW, Bartunek J, Kilic T, Lauten A, Schmeisser A, Zoghi M, Anker S, Sieved H, Mahfoud F., The AFR- PRELIEVE trial: a prospective, non-randomized, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction., Eurointervention, 2019 Aug 29;15(5):403-410. doi: 10.4244/EIJ-D-19-00342.) investigate the safety and efficiency of atrial flow regulator devices and review previous devices in their study. The published data indicate that interatrial shunting is a new alternative for treating HF patients and two different devices have been clinically investigated. Currently, there are two devices under clinical investigation, namely the InterAtrial Shunt Device (IASD®; Corvia Medical, Tewksbury, MA, USA), and the V-Wave device).
The InterAtrial Shunt Device (IASD®; Corvia Medical, Tewksbury, MA, USA) is the world's first transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity to lower left atrial pressure.
The V-Wave device (V-Wave Ltd, Or Akiva, Israel) is based on this concept and on the experience of the creation of interatrial shunts to treat patients with congenital heart disease or ventricular assist devices. The V-Wave device, which permanently reduces left atrial pressure, is composed of an hourglass-shaped nitinol frame with a polytetrafluoroethylene polymer coating on its left side and a valve with 3 bovine pericardium leaflets on its right side to prevent paradoxical embolisms and early shunt closure.
The AFR device differs from these devices in several aspects. It has no incorporated valve tissue. Interatrial communication is large (8 mm). The AFR device is uncoated, made of nitinol mesh. A procedural difference is the necessity to perform a balloon atrial septostomy before AFR implantation, which was performed safely in all cases. Procedural success rate and patency of the device (confirmed by TEE post-procedure and at three-month follow-up) placement of an ASD closure device with a relatively short device during the procedure is low because it is fully retrievable up to final deployment. No stroke/TIA or thrombus on the device was observed at three months using TEE.
Brief Description Of The Drawings:
Figure 1. A schematic illustration of a preferred embodiment of the invention that is used as a dynamic flow controller in heart failure patients having three types as 1 a, 1 b and 1 c.
Figure 2. A schematic illustration of a preferred embodiment of the invention having component details including shape memory alloy wires formed to create a fenestration with desired diameter, a pressure sensor located high-pressure side of the fenestrated shunt, a connecting hub of the device to the pusher cable, a stimulation device with an internal battery and software (detailed version of Fig. 1 c).
Figure 3. A schematic illustration of a preferred embodiment of the invention with different diameters (D1 , D2, D3).
Figure 4. A schematic illustration of a preferred embodiment of the invention showing the change on the formed shape memory alloy with diameter expansion.
Figure 5. A schematic illustration of a preferred embodiment of the invention showing the dilatation balloon catheter for fenestration enlargement of the device. Figure 6. A schematic illustration of a preferred embodiment of the invention having details including a glass shaped balloon for diameter decrease and marker bands showing the distance between the balloon inflated parts to calibrate the diameter of the device fenestration.
Figure 7. A schematic illustration of a preferred embodiment of the delivery system of the invention having details including a pusher cable handle for rotating to screw on and off, a pusher cable main body, a loader for the device, a delivery sheath, a device connected to the pusher cable, and a connection part of the pusher cable to the device body.
Description of References in Figures 101 : wires
102: pressure sensor 103: connecting hub 104: stimulation device 105: balloon inflation catheter 106: pusher cable handle
107: pusher cable 108: loader 109: delivery sheath 110: pusher cable 111 : connection part of the pusher cable
112: time-glass shaped balloon
113: marker bands Detailed Description Of The Invention:
A disclosure for a specific embodiment will be described with the related drawings and references. This disclosure may be embodied in different designs and shapes and should not be limited to the archetype. These forms are described to complete this disclosure and the scope of the disclosure to those skilled in the art. Although the wording used to describe the disclosure and the related drawings in detailed explanations are not a limitation for the similar descriptions. The drawings are the bases to make the description with references and the detailed explanations aim to describe a device that regulates the blood volume and pressure between the chambers of the heart by changing the cross-section of the fenestration mechanically and semi or fully automatically to regulate the hemodynamic of the patient. This disclosure does not describe a device design only but brings a new strategy to the physicians to treat their patients according to the clinical outcomes of the patient through the therapy. Figure 1 a,1 b,1 c shows a device that is used to control and adjust the pressure and the amount of the blood volume between the adjacent sides of the device where it is implanted. Figure 1 a shows a device that has a mechanical structure to change these properties with a balloon inflation catheter (105) and Figure 1 b shows a device with a pressure sensor (102) and external energy transfer to change the dimensions of the device, finally Figure 1 c shows a device with a stimulation device (104) with an internal battery -externally chargeable- and software to sense the pressure, flow changes and adjust accordingly to stabilize the hemodynamic of the patient. The embodiment consists of one or more wires (101 ) to form a certain diameter (D1 )in the central part of the device with a shape- memory alloy that is specially calculated and designed elastic and plastic deformation properties at the bending location and the diameter is expanded to a certain diameter by the balloon inflation catheter (105) or external energy transfer or a stimulation device (104) with internal battery and software which sense the pressure changes and transfer energy to change the diameter accordingly. The invention has 3 versions: 1 a is a mechanical device that consists of only shape-memory alloy and it has special design angulation between the loops of the wires with enough force applied by the balloon inflation catheter (105) to cause plastic deformation at the bending area of the wires to change the fenestration from D1 to D2 and the distances between the discs from L1 to L2 and D2 to D3 and the distance from L2 to L3, respectively but the different nominal diameter of the balloon catheter for the desired diameter achievement. To decrease the diameter from D3 to D2, length L3 to L2 and D2 to D1 , L2 to L1 , the same principle is used to apply enough pressure from both sides of the device discs with a specially designed time-glass shaped balloon (112) which applies hydraulic pressure to both sides of the discs when inflated to a high pressure to decrease the length and enough force to create a plastic deformation on the bending from wires of the shape-memory alloy to decrease the D3 to D2, L3 to L2, D2 to D1 , L2 to L1 , respectively. The 1 b device has a pressure sensor (102) sense the pressure changes and an external energy surge delivers energy need to deform the angulation at the bending points of the shape-memory alloy to expand the D1 to D2, D2 to D3, respectively and decrease of the diameter is done with time-glass shaped balloon (112) catheter mechanically. Finally, the 1 c device has a pressure sensor (102) on the device and is connected to the stimulation device (104) with an internal battery which can be charged wireless from an external resource and a software stimulation the diameter changes according to the pressure changes obtained from the sensor element. This fully automated device can change the diameter to any diameter required while the first and second design can do it to the predetermined diameter steps. The invention device has two discs on both sides of the chambers adjacent to the device and a connection waist which is specially formed wires that the length between the discs adjusting the diameter of fenestration with enough force applied to create a plastic deformation. The device can be formed with or without a connecting hub (103) to the delivery cable, with or without a pressure sensor(102). The invention device can be made with or without an external coating for preventing thrombus formation or sudden closure of the permanent shunt. As all structural heart interventional procedures, an introducer is placed according to the calibration of the delivery sheath (109) and a guidewire is advanced and a puncture is created at the desired location where the fenestration needed. After the shunt creation, a balloon dilatation catheter (105) is applied to achieve blood flow between two chambers of the heart and the device without collapsing. The device is loaded to the loader (108), connected to the pusher cable (110) with the connection part of the pusher cable (111 ) to the device body and pushed inside through a pusher cable handle (106) for rotating to screw on and off until it reaches to the implantation location and then the first disc of the device is formed on one side of the heart chamber while the waist in located inside the punctured tissue and the second disc is formed on the other side. The device is released from the pusher cable (107) and a control angiogram is performed to observe the shunt with TEE or TTE. Furthermore, the post dilatation can be done to achieve the exact diameter of the fenestration part. The device can be post-dilated to a desired diameter with the same intervention case or later when needed from D1 to D2, D2 to D3 and can be decreased with a time-glass shaped balloon (112) to the desired diameter from D3 to D2, D2 to D1 , respectively.The second version, 1b, has a pressure sensor (102) to sense the pressure changes and the device fenestration will be adjusted accordingly either by a dilatation balloon catheter (105) for fenestration enlargement or time-glass shaped balloon (112) to decrease the diameter. The third version of the device, 1c, has a pressure sensor (102) to sense the pressure changes and adjust the fenestration diameter with a stimulation device (104) with an internal battery and software by delivering energy to the bending location of the shape-memory alloy to change the angulation to increase and decrease the central diameter of the fenestration. The marker bands (113) shows the distance between the balloon inflated parts to calibrate the diameter of the device fenestration.

Claims

1. A dynamic flow controller for heart failure characterized in that it is a frame keeping a shunt between the chambers of the heart with a certain diameter (D1) which can be changed, increased or decreased to adjust the cross-section of the fenestration in the center of the device to control the pressure gradient between the chambers of the heart and the regulate the volume of the blood transferred from one side to another side with mechanical properties of the design using either a dilatation balloon for the enlargement of the central diameter (D1 ) to (D2, D3) respectively or with a time-glass shaped specially designed balloon to decrease the central diameter of the device from (D3) to (D2, D1 ), respectively.
2. A dynamic flow controller for heart failure according to Claim 1 , wherein it is a frame keeping a shunt between the chambers of the heart with a certain diameter with a pressure sensor that senses the pressure changes between the chamber of the heart and detects the need of a cross-section (diameter) change to enlarge enough to decrease the pressure gradient of the high-pressure side to the desired level.
3. A dynamic flow controller for heart failure according to Claim 1 ; wherein it is a frame keeping a shunt between the chambers of the heart with a certain diameter with a pressure sensor that senses the pressure changes between the chamber of the heart and detects the need of a cross-section (diameter) change to enlarge enough to decrease the pressure gradient of the high-pressure side to the desired level by the help of an implantable unit with a power source (battery) and software connected to the device with a connecting cable to transfer energy and regulates the pressure gradient and amount of the blood transferred from one side to the other side changing the fenestration diameter of the device accordingly with the help of the software validated to regulate the pressure to keep it within the desired limits to perform the therapy.
4. A dynamic flow controller for heart failure according to Claim 1 ; wherein the time-glass shaped balloon catheter is a specially designed balloon form that the diameter of the balloon increases by increasing the hydraulic pressure inside the large balloon parts and decreases the length between two parts of the high diameter spherical part of the balloons to apply force to both surfaces of the dynamic flow controller for heart failure device to decrease the diameter of the fenestrated central part (D3) to (D2, D1) with calibrated hydraulic pressure change inside the balloon catheter, respectively. The distance between the two discs are forced to decrease by the hydraulic pressure of the balloon catheter which forces the device to decrease the diameter of the fenestration at the center of the device and with plastic deformation of bent shape memory alloy wires, the diameter is decreased to the desired length to adjust the pressure and the amount of the blood transferred to the other side of the heart chamber.
5. A dynamic flow controller for heart failure device (1 a,1 b,1 c) according to Claim 1 , wherein it is formed from shape memory alloys to have a precalculated plastic deformation force to change the internal diameter by applying sufficient force to change the diameter with plastic deformation. The device has superelastic characteristics and the diameter of the device will decrease with a certain proportion after the enlargement of the fenestration diameter by definition which needs to be added to the desired diameter and when the dilatation balloon is inflated to an oversize calculated and tested according to the metallurgical characteristics of the shape memory alloy after elastic recoil of the diameter the fenestration reaches to the desired diameter.
PCT/TR2020/050415 2020-05-13 2020-05-13 A dynamic flow controller for heart failure WO2021230830A1 (en)

Priority Applications (1)

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PCT/TR2020/050415 WO2021230830A1 (en) 2020-05-13 2020-05-13 A dynamic flow controller for heart failure

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GB2621355A (en) * 2022-08-09 2024-02-14 Imperial College Innovations Ltd Fail safe interatrial shunt device

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US20050055082A1 (en) * 2001-10-04 2005-03-10 Shmuel Ben Muvhar Flow reducing implant
WO2017031068A1 (en) * 2015-08-17 2017-02-23 Tufts Medical Center, Inc. System for treating acute and chronic heart failure
TR201620031A2 (en) * 2016-12-29 2020-04-21

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Publication number Priority date Publication date Assignee Title
US20050055082A1 (en) * 2001-10-04 2005-03-10 Shmuel Ben Muvhar Flow reducing implant
WO2017031068A1 (en) * 2015-08-17 2017-02-23 Tufts Medical Center, Inc. System for treating acute and chronic heart failure
TR201620031A2 (en) * 2016-12-29 2020-04-21

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2621355A (en) * 2022-08-09 2024-02-14 Imperial College Innovations Ltd Fail safe interatrial shunt device

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