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WO2024235777A1 - Débridement par ultrasons transcathéter de valvule fibrocalcifiée et extension de feuillet mécanique auxiliaire associée à une prothèse de valve temporaire - Google Patents

Débridement par ultrasons transcathéter de valvule fibrocalcifiée et extension de feuillet mécanique auxiliaire associée à une prothèse de valve temporaire Download PDF

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Publication number
WO2024235777A1
WO2024235777A1 PCT/EP2024/062685 EP2024062685W WO2024235777A1 WO 2024235777 A1 WO2024235777 A1 WO 2024235777A1 EP 2024062685 W EP2024062685 W EP 2024062685W WO 2024235777 A1 WO2024235777 A1 WO 2024235777A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
stent valve
ablation unit
aortic
expandable stent
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/EP2024/062685
Other languages
English (en)
Inventor
Enrico FERMI
Enrico Pasquino
Francesco Bonetti
Franco OSTA
Mario DI CECIO
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.)
AorticLab Italy SRL
Original Assignee
AorticLab Italy SRL
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 AorticLab Italy SRL filed Critical AorticLab Italy SRL
Publication of WO2024235777A1 publication Critical patent/WO2024235777A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22098—Decalcification of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor

Definitions

  • This invention relates to systems for the treatment of aortic stenosis due to fibrosis and/or calcification of the valve leaflets, with the aim of improving or restoring an adequate hemodynamic profile of the patient, deferring the implantation of an artificial bioprosthesis, of limited duration, often lower than the patient's life expectancy.
  • aortic valve stenosis The treatment of aortic valve stenosis is frequently based on the implantation of a valve bioprosthesis using the TAVI procedure or surgical aortic valve replacement.
  • TAVI has increased markedly in younger patients, despite the lack of data on long-term valve durability.
  • Balloon aortic valvuloplasty can be associated with poor outcomes, but in specific patients who are haemodynamically unstable it may serve as a bridge to surgery or TAVI, or as a palliative measure where surgery is contraindicated.
  • a transcatheter device for the treatment of aortic valve stenosis due to calcific dystrophy, through the emission of an impulsive ultrasound field at two different frequencies.
  • the device includes a temporary artificial valve capable of replacing the activity of the patient's native valve during the duration of the treatment.
  • the solution described has some limitations, in particular: the availability of a limited number of sizes of devices compared to the great variability of the sizes of the patients' native valves; the risk that the artificial valve does not always adapt correctly to the native valve due to the many physiological variations present in cases of aortic valve stenosis (risk of paravalvular leakage).
  • the present invention concerns a device as defined in the claims.
  • the invention concerns a device for the treatment of aortic stenosis comprising at least one ultrasonic ablation unit and one expandable stent valve.
  • the ablation unit(s) is/are configured to directly act on aortic valve leaflet(s).
  • the expandable stent valve is configured to clamp an aortic valve leaflet between said stent valve and one ablation unit.
  • the device according to the invention performs the function of treating aortic valve stenosis by combining the action of, preferably low-energy, ultrasound waves with the mechanical stretch action of a stent valve that adapts to the patient's native valve.
  • Ultrasounds allow the debridement of calcified deposits or the modification of the characteristics of the fibrotic leaflets, through "spaces" created in the spongiosa by the effect of cavitation bubbles of dissolved gas, inside the spongiosa-layer. The result is the restoration of pliability and the improvement of blood flow and reduction of the transvalvular pressure gradient.
  • the piezoelectric transducers may advantageously generate two low intensity ultrasound shockwaves, for instance around 3 MHz and 100-200 KHz frequencies, without temperature increase. The combination of two frequencies enhances the cavitation effect and so the efficacy of the treatment.
  • the invention is also applicable to the treatment of degenerated bioprosthesis.
  • the invention relates to a novel device that uses, preferably low-energy, shock waves emitted via ultrasonic (e.g. piezoceramic) transducers directly on valve leaflets in combination with the stretch action of an expandable stent, equipped with an artificial temporary valve.
  • ultrasonic e.g. piezoceramic
  • This expandable stent valve combines the pushing action on the aortic valve, with the effect of ultrasounds on the leaflets.
  • FIG. 1 and 2 One example of the device according to the invention is illustrated in figures 1 and 2. It includes: a "deployment” section, i.e. a catheter to reach the heart valve site, through percutaneous access; a multi lumen catheter that allows the passage of electrical connection wires with the ablation unit(s) and pulling wires to allow the movements of those various elements; a bi lumen tube; a temporary artificial valve, preferably made of silicone or tissue, located within an expandable stent (Fig. 3a, 3b, 3c, 3d, 8b); a handle with the movement controls of the various elements (Fig. 7a)
  • a "deployment” section i.e. a catheter to reach the heart valve site, through percutaneous access
  • a multi lumen catheter that allows the passage of electrical connection wires with the ablation unit(s) and pulling wires to allow the movements of those various elements
  • a bi lumen tube a temporary artificial valve, preferably made of silicone or tissue, located within an expandable stent (Fig.
  • the motion controls managed through the handle is achieved as follows: steering of the distal section of the outer catheter of the device; retraction of the external sheath of the device to allow the opening of the artificial valve and the release of the ablation units; flexion and extension of the ablation units; rotation of the ablation units with 1:1 torque transmission cable mounted on steel tube: this solution can guarantee +/- 180° torquability when the device is deployed at the extrados of the aortic arch, fine positioning of the artificial valve inside the native valve controlled expansion of the expandable stent.
  • the impulsive electrical signal may be supplied by a voltage generator capable of supplying signals, preferably at two alternating frequencies of approximately 3MHz and 100-200KHz.
  • the ablation units are similar to those described in patent application WO2020/151995A1 and may therefore be based on lead zirconate titanate PZT piezoceramic transducers, mounted on support structures which provide the backing function (ultrasound focusing without back scattering).
  • Other methods besides PZT can be employed to generate shockwave ultrasounds, such as arc discharge in water, according to scientific literature.
  • the catheter advances in the vessels of the lower limbs, from the femoral access, along the iliac artery, the abdominal and thoracic aorta, to reach, through the aortic arch, the stenotic aortic valve (Fig. 4a, 4b).
  • the hypotube of the device (Fig. 8), allows the use of a guidewire for the correct navigation of the device and the correct positioning of the artificial valve in the native one of the patient.
  • the ablation units Once the ablation units have been released, they can be controlled, flexed or extended, advanced or retracted, rotated of 360°, in order to position them in the native valve area to be treated (Fig. 4f, 4g, 4h).
  • the patient's valve leaflets are clamped between the ablation units and the valved stent (Fig. 4h).
  • the operator can then expand the valved stent, (Fig. 4i), to obtain both an improvement in the adhesion to the native valve, reducing or eliminating the risk of paravalvular leakage, and a stretching action on the leaflets to improve the efficacy of the treatment (combination of active physical energy and mechanical pushing force: the expandable valve stent can stretch the leaflets under the remodelling effect of ultrasound field).
  • the present invention includes several original features, such as : the parallelization of the wide set of controls, described previously, to develop a small-sized device; the expansion of a valved stent, to perform a sort of delicate valvuloplasty under the action of the ultrasound field, which acts on fibrosis and calcified deposits, reducing both; the artificial valve, inside the expandable stent, that allows the ultrasound treatment to be carried out for a relatively long period, such as tens of minutes, until the desired haemodynamic improvement is obtained; the system can be repositioned several times during the treatment session, allowing the control of hemodynamic parameters, and being able to treat different leaflets or different portions of the stenotic native valve; the expandable stent allows it to adhere properly to the walls of the native valve during treatment.
  • Fig. 1 shows the set of functional modules of the device, represented graphically in Fig. 2 (top view) and Fig. 5 (side view).
  • Fig. 6a, 6b, 6c show different views of the support module for placing the device on the operating table.
  • the spherical joint of the handle can be clamped in the spherical joint clamp holder of the support module.
  • the spherical joint has three rotational degrees of freedom between the two attached components. The device is so free to rotate relative to the support module along all three axes. This solution allows you to orientate the device on the operating bed.
  • the lead screw in fig. 6b allows you to move the device along the support module by acting on the knobs at the ends: by turning them, the device moves forward or can be retracted.
  • the movements of the different "modules" are performed by means of tie wires or moving directly the outer catheter, the multi-lumen or the tubes constituting the sub-units (Fig. 8, 9, 10, 11,13).
  • the cardan joint transmits motion to the lead screw via two gears (Fig. 9, Fig. 10).
  • the steering function of the outer catheter takes place via tie wires that run in the bi-lumen tube (Fig. 13).
  • the knob by rotating, pulls cables, made of kevlar or other high-strength material (i.e., high grade polyester) which bend the distal section.
  • the expandable valve stent has the "catheter coupling ends" constrained to two different tubes which can slide into each other (Fig. 8b).
  • the substructure of Fig. 8 shows the knob control to draw one tube and keep the other fixed, resulting in the expansion of the stent for compression (Fig. 3).
  • valve assembly is provided with an external skirt.
  • the external skirt enhances adherence to the patient's native valve, minimizing or eliminating paravalvular leakage, even with irregularities at the valve site (annulus, leaflets).
  • the stent's upper opening ensures ample blood flow, preventing obstruction of the coronary ostia.
  • the valve's concave belly is designed to deform flexibly, maintaining ease of opening during the systolic phase.
  • the apex of the coaptation zone is elevated above the rest of the leaflet's free margin. This elevation optimizes valve function by maintaining leaflet coaptation during stent expansion.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif destiné au traitement d'une sténose aortique comprenant au moins une unité d'ablation par ultrasons et une valve d'endoprothèse extensible.
PCT/EP2024/062685 2023-05-15 2024-05-08 Débridement par ultrasons transcathéter de valvule fibrocalcifiée et extension de feuillet mécanique auxiliaire associée à une prothèse de valve temporaire Pending WO2024235777A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2023062890 2023-05-15
EPPCT/EP2023/062890 2023-05-15

Publications (1)

Publication Number Publication Date
WO2024235777A1 true WO2024235777A1 (fr) 2024-11-21

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/062685 Pending WO2024235777A1 (fr) 2023-05-15 2024-05-08 Débridement par ultrasons transcathéter de valvule fibrocalcifiée et extension de feuillet mécanique auxiliaire associée à une prothèse de valve temporaire

Country Status (1)

Country Link
WO (1) WO2024235777A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12446905B2 (en) 2023-04-20 2025-10-21 Histosonics, Inc. Histotripsy systems and associated methods including user interfaces and workflows for treatment planning and therapy

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160135828A1 (en) * 2014-11-14 2016-05-19 Shockwave Medical, Inc. Shock wave valvuloplasty device and methods
WO2020151995A1 (fr) 2019-01-24 2020-07-30 AorticLab srl Dispositif pour le traitement de calcification de tissu

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160135828A1 (en) * 2014-11-14 2016-05-19 Shockwave Medical, Inc. Shock wave valvuloplasty device and methods
WO2020151995A1 (fr) 2019-01-24 2020-07-30 AorticLab srl Dispositif pour le traitement de calcification de tissu
US20220061869A1 (en) * 2019-01-24 2022-03-03 AorticLab srl Device for the Treatment of Tissue Calcification

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12446905B2 (en) 2023-04-20 2025-10-21 Histosonics, Inc. Histotripsy systems and associated methods including user interfaces and workflows for treatment planning and therapy

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