WO2025149657A1 - Protection d'entrée de pompe d'assistance cardiaque - Google Patents

Protection d'entrée de pompe d'assistance cardiaque

Info

Publication number
WO2025149657A1
WO2025149657A1 PCT/EP2025/050603 EP2025050603W WO2025149657A1 WO 2025149657 A1 WO2025149657 A1 WO 2025149657A1 EP 2025050603 W EP2025050603 W EP 2025050603W WO 2025149657 A1 WO2025149657 A1 WO 2025149657A1
Authority
WO
WIPO (PCT)
Prior art keywords
spacing
organ
pump body
pump
heart
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/EP2025/050603
Other languages
English (en)
Inventor
Lars Bredenbreuker
Aurélien NICOL
Carlo ZARDIN
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.)
Brightflow
Original Assignee
Brightflow
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 Brightflow filed Critical Brightflow
Publication of WO2025149657A1 publication Critical patent/WO2025149657A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Definitions

  • the present invention relates to a percutaneous implantable heart assist device.
  • Heart failure remains a major health problem, with an estimated prevalence of 1-2% in the adult population of developed countries increasing to 10% from the age of 70 years.
  • the spacing organ comprises at least one radial portion extending along a secondary elongation axis, said secondary elongation axis extending radially with regards to the elongation axis, - the spacing organ may be configured to be free to move with regards of any of the anatomical walls of the patient’s heart,
  • the spacing structure may be a radially expandable structure, with regards to the elongation axis,
  • the spacing structure may be an expandable mesh
  • the spacing organ may be at least partially made of a nitinol material.
  • FIG. 1 is a schematic longitudinal section view of a patient’s heart
  • FIG. 2 is the same schematic view as figure 1, in which a cardiac assisting device has been inserted inside the patient’s heart,
  • FIG. 3 is a perspective view of a first embodiment of an assisting device according to the present invention.
  • FIG. 4b is a perspective view of the embodiment of figure 4a
  • FIG. 5 is a perspective view of a further assisting device according to the present invention.
  • FIG. 6 is a perspective view of a preferred embodiment of the present invention.
  • FIG. 7 is an embodiment of the outflow cannula of the embodiment of figure 6.
  • the oxygen-poor blood flow coming from a patient’s body is led to the patient’s heart 100 by the inferior/superior vena cava 101 and enters the patient’s heart 100 through the right atrium 102.
  • the oxygen-poor blood flow then crosses the tricuspid valve and enters the right ventricle 104.
  • the oxygen-poor blood flow then leaves the right ventricle 104 by crossing the pulmonary valve and flows towards the lungs through the pulmonary artery 106.
  • the blood flow is oxygenated in the lungs and is fed once again towards the heart 100 by the pulmonary veins and reinters the heart 100 through the mitral valve inside the left atrium 108 and then into the left ventricle 110.
  • the oxygen-rich blood flow then crosses the aortic valve and leaves the heart 100 through the aorta towards the patient’s body.
  • the vena cava 101 is part of the human heart 100, in a broad interpretation of the human heart 100.
  • the present invention is about a cardiac assisting device 10 configured to be implanted inside a patient’s heart 100.
  • the cardiac assisting device 10 can be implanted in any chamber of the patient’s heart 100.
  • the cardiac assisting device 10 is classically configured to circulate a blood flow from a first chamber Ci of the patient’s heart 100 towards a reception conduct CR by bypassing a second chamber of the patient’s heart 100 through which the blood would naturally flow.
  • bypassing means than, with regards to the natural circuit of the blood flow inside a patient’s heart 100, at least one of the chambers of this natural circuit (right atrium 102, right ventricle 104, left atrium 108, left ventricle 110), is bypassed by the blood flow once the cardiac assisting device 10 is implanted and functioning.
  • Each chamber of the patient’s heart 100 is delimitated by at least one anatomical wall presenting some natural elasticity.
  • said assisting device 10 comprises: a device inlet 12 configured to enable the blood flow to enter the assisting device 10 from the first chamber Ci, a device outlet 14 configured to enable the blood flow to exit the assisting device 10 inside the reception conduct CR, a rotary pump 16 connecting the device inlet 12 to the device outlet 14.
  • the device inlet 12, device outlet 14 and rotary pump 16 can be located, once implanted, either in the same chamber of the patient’s heart 100 or in different chambers of the patient’s hearts 100. Depending on the size of the patient’s heart 100, the device inlet 12 might be located very close to an anatomical wall of the patient’s heart 100.
  • the rotary pump 16 comprises a pump body 18 with a pump inflow 18i and a pump outflow 18o.
  • the pump body 18 extends at least partially along an elongation axis X.
  • the pump body 18 presents an external surface S.
  • the rotary pump 16 is preferably an axial pump (see figure 6).
  • the rotary pump 16 thus extends axially along the elongation axis X.
  • the pump inflow 18i, any impeller 20 (see below) and the pump outflow 18o are thus all aligned along the elongation axis X.
  • the device inlet 12 is thus aligned along the elongation axis X, in order to guide the blood flow inside the device 10 from the device inlet 12 to the pump outflow 18o along the elongation axis X.
  • the assisting device 10 thus extends in a straight line along the extension axis X from the pump inflow 18i to the pump outflow 18o, and preferably from the inlet inflow 12 to the pump outflow 18o.
  • This particular straight-line shape enables the assisting device 10 to maintain a small diameter all over the length of the assisting device 10 and make it thus easily implantable via catheter, without any need of deforming the pump body 18 during (or after) implantation.
  • the device outlet 14 is coaxially arranged at a downstream portion of the device 10 and comprises at least one outlet opening O enabling blood to flow out the device 10 inside the reception conduct CR.
  • the device outlet 14 is configured to change an orientation of the outlet opening O with regards to the elongation axis X.
  • the device outlet 14 extends at least partially along an outflow axis Y, different from the extension axis X. More precisely, the outflow axis Y and the elongation axis X intersect each other at an angle ranging from 1 to 189°. Preferably the outflow axis Y and the elongation axis X intersect each other at an angle ranging from 1 to 90°.
  • the outlet opening O is not aligned with the pump outflow 18o. This variable unalignment of the outlet opening O with the pump outflow 18o, enables the device 10 to adapt to a higher variety of heart sizes and shapes without causing any damages.
  • the device outlet 14 is, contrary to the rotary pump 16, deformable.
  • the device outlet 14 is preferably a bendable cylinder.
  • the device outlet 14 is configured to adapt to the patient’s heart 100 morphology.
  • the device outlet 14 is preferably made of flexible tube materials, and can for example be a coated meshed or braided or spiraled stent made of, for example, Nitinol, and/or stainless steel.
  • the device outlet 14 folds and unfolds, thus enabling an easy introduction and it can further, once implanted, adapt the patient’s heart shape depending on the position of the rotary pump 16 inside the patient’s heart 100.
  • This flexibility precisely offers the possibility to vary the angle between the pump outflow 18o and the device outlet O thus improving the adaptation of the device 10 to the natural shape of the patient’s heart 100 without affecting the shape of the rotary pump 16.
  • the device outlet 14 comprises a deformable cannula 140.
  • the deformable cannula 140 presents the general shape of a tube with a tapered end at a distal extremity.
  • the deformable cannula 140 thus comprises a central part formed by a coil (made of, for example, Nitinol, and/or stainless steel), a proximal extremity configured to secure the deformable cannula 140 to the pump outflow 18o and a distal extremity formed by a mesh and presenting a tapered shape with a small diameter at an upstream extremity and a large diameter at a downstream extremity.
  • the tapered end can be crimped during implantation and expands after implantation.
  • the deformable cannula 140 is further coated with, for example PU, PTFE, ePTFE.
  • the diameter of the coil ranges from 6 to 10mm, preferably 8mm and the larger diameter of the tapered extremity ranges from 18 to 21mm, preferably 20mm.
  • the wall thickness of the coil and the tapered end ranges from 0,2 to 0,4mm.
  • the coil is formed one single wounded wired (spiral), thus forming a structure of parallel filaments. This specific structure enables the deformable cannula 140 to be folded with a small bending radius while presenting high radial forces (with regards to the state of the art) and avoiding the cannula to be kinked as a kink would block the blood flow circulation.
  • the rotary pump 16 comprises a motor and an impeller 20. More particularly, the pump body 18 surrounds the impeller 20 which extends between the pump inflow 18i and the pump outflow 18o.
  • the impeller 20 is preferably magnetically coupled to the motor.
  • the impeller 20 generates depression in order to drive the blood flow inside the assisting device 10.
  • This negative pressure is thus exerted in the chamber of the patient’s heart 100 in which the assisting device 10 is implanted (more particularly in which the device inlet 12 is located). Said negative pressure is therefore also exerted on the anatomical wall of the chamber of the patient’s heart 100. If the device inlet 12 is located closely to the anatomical wall of the chamber, said anatomical wall could be deformed and drawn towards the device inlet 12. This deformation could lead to injuries and/or an obstruction of the device inlet 12.
  • the pump body 18 comprises a spacing organ 22, as can be seen on figures 3, 4a and 4b.
  • the spacing organ 22 extends at least partially radially from the external surface S. More precisely, the spacing organ 22 extends at least partially away from the elongation axis X. This way, the spacing organ 22 is configured to maintain a predefined space E between any anatomical walls of the patient’s heart 100 and the device inlet 12.
  • the space E ranges from 15 mm to 30 mm.
  • the spacing organ 22 extends at least partially along the elongation axis X. It thus presents a longitudinally length ranging from 10 mm to 40 mm along the elongation axis X.
  • the spacing organ 22 presents a distal extremity and a proximal extremity with regards to the elongation axis X, each extremity being secured to the pump body 18.
  • the spacing organ 22 surrounds at least partially the device inlet 12. More particularly, the spacing organ 22 surrounds the at least one inlet opening 12o.
  • the spacing organ 22 presents a distal extremity and a proximal extremity with regards to the elongation axis X, the distal extremity being a free extremity.
  • the spacing organ 22 could comprise at least one spike at least partially extending along the elongation axis X.
  • the spacing organ 22 could comprise several distinct spacing elements 220 distributed around the external surface 6 of the pump body 18 and more particularly over the device inlet 12, like a sort of crown.
  • the spacing organ 22 comprises at least one radial portion extending along a secondary elongation axis X2.
  • This secondary elongation axis X2 extends radially with regards to the elongation axis X. This ensures that at least a part of the spacing organ is remote from the pump body 18 and particularly from the inlet opening 12o.
  • the spacing organ 22 comprises a part at least partially surrounding the pump body 18.
  • the spacing organ 22 comprises a part at least partially surrounding the device inlet 12. More particularly, the spacing organ 22 surrounds the at least one inlet opening 12o.
  • the spacing organ 22 comprises at least one remote portion facing the inlet opening 12o at a distance.
  • the spacing organ 22 is radially elastically deformable.
  • the spacing organ could be at least partially made of Nitinol material.
  • the spacing organ 22 is configured to be free to move with regards of any of the anatomical walls of the patient’s heart 100. This way, regardless of the movements of the implanted assisting device 10, the spacing organ 22 does not pull or tear the anatomic walls and is not pulled or tom by an anatomical wall to which it would be attached, and remains thus entirely functional and able to generate the necessitated space E between any anatomical walls of the patient’s heart 100 and the device inlet 12.
  • the spacing structure is a radially expandable structure, with regards to the elongation axis X.
  • the spacing organ 22 is thus inserted inside the patient’s heart 100 in a folded configuration and, once the assisting device 10 is rightfully in place inside the patient’s heart 100, the spacing organ 22 expands inside the chamber of the patient’s heart, thus protecting the device inlet 12 once everything is in place.
  • the spacing organ 22 displays an extended diameter ranging from 15 to 30mm.
  • the spacing organ 22 is configured to maintain the predefined space E between the anatomical wall of the patient’s heart 100 and the device inlet 12.
  • the assisting device 10 further comprises a support device configure to secure and stabilize the device 10 inside the patient’s heart 100.
  • Said support device comprises at least one outlet support element 25 and, in some embodiments, a pump support element 26.
  • the device 10 comprises a deformable cannula 140 as described here-above, the tapered end of the deformable cannula 140 forms an outlet support device 25.
  • the at least one outlet support device 25 is integral with the device outlet 14 thus forming the deformable cannula 140.
  • the at least one outlet support element 25 is configured to tightly cooperate with a membrane in order to immobilize the pump 16 and the device outlet 14 inside the patient’s heart 100 (or vena cava 101) and enable the patient’s blood flow to be driven from the device inlet 12 to the device outlet 14 through the at least one membrane of the patient’s heart 100, more particularly through the conduct membrane Mi of the reception conduct CR.
  • the outlet support element 24 crosses the conduct membrane Mi and leads the blood of the patient through the conduct membrane Mi.
  • the at least one outlet support element 25 crosses the conduct membrane Mi by means of an artificial anastomosis created percutaneously by a surgeon or an interventional cardiologist.
  • Said anastomosis presents an aperture with a diameter ranging from 5 to 15mm opening inside the reception conduct CR.
  • the aperture is also circumscribed by an edge presenting the regular elasticity and width of the membrane M of the patient’s heart 100.
  • the at least one outlet support element 25 thus presents a central hole presenting a diameter ranging from 5 to 15mm, corresponding to the diameter of the aperture of the anastomosis of the conduct membrane Mi.
  • the device 10 is at least partly deployable from a retracted configuration to an expanded configuration in order to ease its implantation.
  • the at least one outlet support element 25 is deployable from a retracted configuration to an expanded configuration:
  • the retracted configuration enables the at least one outlet support element 25 to be introduced through the conduct membrane Mi of the reception conduct CR, and
  • the at least one outlet support element 25 When expanded, the at least one outlet support element 25 presents an outer diameter ranging from 10mm to 30mm.
  • the outlet support element 25 is configured to extend, once the device 10 is installed inside the patient’s heart 100, from an internal side and from the external side of the conduct membrane Mi.
  • the outlet support element 24 is thus configured to cooperate radially with the edge of the aperture of the conduct membrane Mi. This radial cooperation ensures a tight and strong cooperation between the conduct membrane Mi and the outlet support element 25 (and therefore with the device outlet 14). This radial cooperation thus ensures that the blood flow driven by the assisting device 10 (around 30 to 70% of the complete patient’s blood flow) flows through the conduct membrane Mi, from the inside of the assisting device 10 inside the reception conduct CR of the patient’s heart 100.
  • the at least one outlet support element 25 is configured to be secured to the conduct membrane Mi separating the right atrium 102 or the vena cava 101 from the pulmonary artery 106 as the reception conduct CR of the patient’s heart 100.
  • the outlet support element 25 is configured to be secured to a wall of the superior vena cava 101 or right atrium 102 as the conduct membrane Mi.
  • the support element 25 comprises a first and a second expandable flanges, the expanded configuration of each support element 25 enabling a pinching of the conduct or chamber membrane Mi between the first and second expandable flanges.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Dispositif d'assistance cardiaque (10) conçu pour être implanté dans le cœur d'un patient et comprenant une entrée de dispositif (12) conçue pour s'ouvrir dans la première chambre (Cl), une sortie de dispositif (14) conçue pour s'ouvrir dans le conduit de réception (CR), une pompe rotative (16) reliant l'entrée de dispositif (12) à la sortie de dispositif, la pompe rotative comprenant une roue à aubes (20) placée dans le corps de pompe (18) entre le flux d'entrée de pompe et le flux de sortie de pompe. L'entrée de dispositif est disposée de manière coaxiale au niveau d'une partie amont du corps de pompe. Le corps de pompe comprend en outre un organe d'espacement (22) s'étendant au moins partiellement radialement à partir de la surface externe (S) du corps de pompe, l'organe d'espacement étant conçu pour maintenir un espace prédéfini (E) entre toute paroi anatomique du cœur du patient (100) et l'entrée de dispositif.
PCT/EP2025/050603 2024-01-12 2025-01-10 Protection d'entrée de pompe d'assistance cardiaque Pending WO2025149657A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP24305083.8 2024-01-12
EP24305083 2024-01-12

Publications (1)

Publication Number Publication Date
WO2025149657A1 true WO2025149657A1 (fr) 2025-07-17

Family

ID=89766980

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/050603 Pending WO2025149657A1 (fr) 2024-01-12 2025-01-10 Protection d'entrée de pompe d'assistance cardiaque

Country Status (1)

Country Link
WO (1) WO2025149657A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030100816A1 (en) * 2000-04-01 2003-05-29 Thorsten Siess Paracardial blood pump
WO2015140179A2 (fr) * 2014-03-17 2015-09-24 Nuheart As Système, dispositifs et procédés percutanés
US20180311421A1 (en) * 2017-04-28 2018-11-01 Nuheart As Ventricular assist device and method
WO2024003355A1 (fr) * 2022-07-01 2024-01-04 Htc-Assistance Dispositif d'assistance cardiaque droit traversant la membrane

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030100816A1 (en) * 2000-04-01 2003-05-29 Thorsten Siess Paracardial blood pump
WO2015140179A2 (fr) * 2014-03-17 2015-09-24 Nuheart As Système, dispositifs et procédés percutanés
US20180311421A1 (en) * 2017-04-28 2018-11-01 Nuheart As Ventricular assist device and method
WO2024003355A1 (fr) * 2022-07-01 2024-01-04 Htc-Assistance Dispositif d'assistance cardiaque droit traversant la membrane

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