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EP4251094A1 - Dispositif de transcathéter pour traiter la régurgitation de la valve tricuspide mitrale - Google Patents

Dispositif de transcathéter pour traiter la régurgitation de la valve tricuspide mitrale

Info

Publication number
EP4251094A1
EP4251094A1 EP21899140.4A EP21899140A EP4251094A1 EP 4251094 A1 EP4251094 A1 EP 4251094A1 EP 21899140 A EP21899140 A EP 21899140A EP 4251094 A1 EP4251094 A1 EP 4251094A1
Authority
EP
European Patent Office
Prior art keywords
spacer body
main shaft
distal
transcatheter device
transcatheter
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
EP21899140.4A
Other languages
German (de)
English (en)
Other versions
EP4251094A4 (fr
Inventor
June-Hong Kim
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.)
TAU Medical Inc Korea
TAU Medical Inc
Original Assignee
TAU Medical Inc Korea
TAU Medical Inc
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 TAU Medical Inc Korea, TAU Medical Inc filed Critical TAU Medical Inc Korea
Priority claimed from PCT/US2021/060872 external-priority patent/WO2022115640A1/fr
Publication of EP4251094A1 publication Critical patent/EP4251094A1/fr
Publication of EP4251094A4 publication Critical patent/EP4251094A4/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • FIG. 2 shows a transcatheter device in isolation and in an extended, stretched-out configuration.
  • FIG. 3 shows the left-side lung with the pulmonary artery tree made visible.
  • FIGS. 4A and 4B show a transcatheter device of as implanted in the patient's heart.
  • FIGS. 37A-D show another embodiment of the transcatheter device.
  • FIGS. 16A and 16B show close-up views of a different design for the proximal segment of the main shaft. Shown here is a spacer body 360 (partial view) and the proximal portion of the transcatheter device.
  • the proximal portion comprises a proximal segment 374 of the main shaft and a spiral coil 372 (partial view).
  • the proximal segment of the main shaft has two bends 366 and 368, but there is no curve.
  • spacer body 340 comprises a wire mesh scaffolding 560 covered with an e-PTFE membrane to provide the outer surface.
  • This wire mesh scaffolding 560 gives the spacer body 340 the ability to collapse or expand during the deployment procedure.
  • the main shaft 559 of the transcatheter device has a lumen 566 for insertion of a guidewire.
  • a sleeve gap 568 from the main shaft 559. Because the distal end of the spacer body 340 is not affixed to the main shaft 559 at this sleeve gap 568, the distal end of the spacer body 340 is slidable on the main shaft 559.
  • the main shaft 559 is made of a nitinol core wire 562 sheathed in polyurethane and reinforced with wire braiding 564.
  • FIG. 17 shows another embodiment of the transcatheter device.
  • the distal tail 382 of the transcatheter device 380 has a bend 384.
  • the proximal segment 386 of the main shaft has a single bend 388.
  • the spiral coil 392 is attached to the proximal segment
  • the spiral coil 392 also has a pigtail 393.
  • the spacer body 390 has a boot shape with a curve 394 at its proximal end. There is also a proximal opening 396 and a distal opening 398 on the spacer body 390.
  • FIGS. 19A - H and 19K show various views of an embodiment of the transcatheter device.
  • FIG. 19A shows a side view
  • FIG. 19B shows a longitudinal cross-section, cutaway view
  • FIG. 19C shows a side view at a different rotation
  • FIG. 19D shows a proximal end-on view.
  • the transcatheter device has a spacer body 480, a spiral coil 486, and a distal tail 484.
  • the spiral coil 486 has a hook 492 for recapturing the transcatheter device if it needs to be pulled out.
  • the spacer body 480 has a generally cylindrical shape with conical ends.
  • the spacer body 480 has a proximal opening 483 and a distal opening 485 to allow blood flow therethrough.
  • the distal tail 484 has a bend 506.
  • FIG. 19B (transverse cross-section) shows that the spacer body 480 comprises a wire mesh scaffolding 496 covered with an e-PTFE membrane to provide the outer surface.
  • This wire mesh scaffolding 496 gives the spacer body 480 the ability to collapse or expand during the deployment procedure.
  • FIG. 19E shows an end-on view of the wire mesh scaffolding 496.
  • the main shaft 490 has a lumen 488 for insertion of a guidewire.
  • At the distal end of the spacer body 480 there is a sleeve gap 508 from the main shaft 490.
  • the main shaft 490 is made of a nitinol core wire 497 reinforced with polyurethane braiding 495.
  • FIG. 19F shows the heart in systole with the tricuspid valve leaflets 503 closed around the spacer body 480.
  • FIG. 19G shows the heart in diastole with the tricuspid valve leaflets 503 in open position.
  • the tricuspid valve leaflets 503 are spread apart from the spacer body 480, thereby allowing blood flow around the spacer body 480. See that the L-shaped bend 506 in the distal tail 484 helps the distal portion of the spacer body 480 to be closer to the supraventricular crest 505. This bend 506 also directs the distal tail 484 into the right pulmonary artery (instead of the left pulmonary artery).
  • the main shaft 519 is made of a nitinol core wire 517 reinforced with polyurethane braiding 525.
  • the bend 536 in the distal tail 534 helps the distal portion of the spacer body 530 to be closer to the supraventricular crest 505. This bend 536 also directs the distal tail 534 into the right pulmonary artery (instead of the left pulmonary artery).
  • FIG. 21H is a close-up view showing the distal portion of spacer body 530 abutting against the supraventricular crest 505. Also see that the bend 531 at the boot-shaped spacer body 530 boot abuts against the carvotricuspid isthmus.
  • FIGS. 22A and 22B illustrate how the spacer body on the transcatheter device could be "self-centering" within the tricuspid valve.
  • FIG. 22A shows the transcatheter device comprising a spacer body 570, proximal segment 572 of the main shaft, and distal tail 576. The location of the supraventricular crest is shown in the dashed circle. The distal tail 576 has a bend 574 that facilitates positioning of the spacer body against the supraventricular crest.
  • the anterior, septal, and posterior leaflets are labelled. An edge-on view of the tricuspid annulus is also shown. As seen in FIG. 22A, there is flexibility in the lateral movement relative to the posterior leaflet.
  • FIG. 22A there is flexibility in the lateral movement relative to the posterior leaflet.
  • FIGS. 25A - 25C show different embodiments of the distal tail.
  • FIG. 25A shows a distal tail 580 having a bend 582.
  • Distal tail 580 extends from the distal end 584 of the spacer body.
  • A2 is the inner angle in the bend 599b at the curve in the boot-shaped spacer body 590. Angles A1 and A2 could be in the range of 80 - 120°.
  • A3 is the inner angle of the bend 599c in the main shaft 592 as it converts to the proximal segment 594.
  • FIG. 36B shows a transection view along line B of FIG. 36B.
  • Seen here is the main shaft 760 having a main lumen for the guidewire.
  • the air or saline flows through hole 768 in the main shaft 760 to inflate/deflate the balloon-type spacer body 732.
  • FIG. 36C shows a cross-section view along line A of FIG. 35B.
  • Seen here is the main shaft 760 having a main lumen 758 and the accessory channel 762.
  • the thickness of the wing 804 is less than the thickness of the spacer body 802.
  • the thickness of the wing 804 (as measured along the transverse axis T that is orthogonal to the wing and the longitudinal axis of the spacer body) is 0.5 - 10 mm; and in some cases, 0.5 - 6 mm.
  • FIG. 43 shows another example of a transcatheter device with wings on the spacer body.
  • Transcatheter device 850 has a distal tail 856 and a proximal portion 858. In between the distal tail 856 and the proximal portion 858 is a spacer body 842.
  • the spacer body 842 has an hourglass shape with a thinner waist 844 near the middle. At this waist 844, there are two wings 846.
  • the proximal portion 858 of the transcatheter device 850 comprises a proximal segment 852 of the main shaft and a spiral coil 854. Also shown is a proximal opening 848 on the spacer body 842.
  • FIGS. 44A-C show another example of a transcatheter device with multiple smaller winglets on the spacer body.
  • Transcatheter device 860 has a distal tail 866 and a main shaft with a proximal segment 870 thereof. In between the distal tail 866 and the proximal segment 870 is a spacer body 862.
  • the spacer body 862 has three small winglets 864 on each side, for a total of six winglets 864.
  • the transcatheter device 860 comprises a spiral coil 872 and a distal hole 868 on spacer body 862.
  • spacer body 862 also has a proximal hole 874.
  • FIG. 44C is a side view of the transcatheter device 860 showing two bends in the main shaft.
  • FIGS. 47A and B are illustrations of the tricuspid valve shown as a schematic model from a side view. Shown here is the spacer body 882 of transcatheter device 880 in operation when installed in the tricuspid valve.
  • FIG. 47A shows the tricuspid valve in closed configuration during ventricular systole, with ventricular pressure in the direction of arrow FI. This fluid pressure causes the canopy 890 to swell open and abut against the valve leaflets 822 to provide coaption of the spacer body 882 to the tricuspid valve.
  • the shape of canopy 890 is held by the strings 892 that are attached to the tether 894, which is attached to the main shaft 896 of the transcatheter device 880.
  • the total length of the distal tail 622 is about 20 cm.
  • the length of distal segment 624 is about 5 cm.
  • the length of middle segment 626 is about 5 cm.
  • the length of proximal segment 628 is about 10 cm.
  • the length of the proximal segment 656 of the main shaft is about 5 cm. Also note that proximal segment 656 of the main shaft has a rounded gooseneck curve 657 as it connects with spacer body 650.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif transcathéter pour le traitement de la régurgitation de la valvule tricuspide. Le dispositif transcathéter comprend une tige principale, une partie proximale, une queue distale et un corps d'espacement monté sur la tige principale et situé entre la partie proximale et la queue distale. Ce dispositif transcathéter pourrait être utilisé pour traiter une régurgitation de valvule tricuspide dans le coeur d'un patient. Tout ou partie du dispositif transcathéter est supporté par la tige principale. Le corps d'espacement est monté sur la tige, qui se déplace à travers le corps d'espacement. L'invention concerne également un ensemble de coaptation qui comprend le dispositif transcathéter, et une méthode de traitement de la régurgitation de la valve tricuspide à l'aide du dispositif transcathéter.
EP21899140.4A 2020-11-25 2021-11-24 Dispositif de transcathéter pour traiter la régurgitation de la valve tricuspide mitrale Pending EP4251094A4 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US202063118631P 2020-11-25 2020-11-25
US202163137589P 2021-01-14 2021-01-14
US202163146552P 2021-02-05 2021-02-05
US202163163772P 2021-03-19 2021-03-19
US202163180656P 2021-04-28 2021-04-28
US202163224337P 2021-07-21 2021-07-21
US202163227871P 2021-07-30 2021-07-30
PCT/US2021/060872 WO2022115640A1 (fr) 2020-11-25 2021-11-24 Dispositif de transcathéter pour traiter la régurgitation de la valve tricuspide mitrale

Publications (2)

Publication Number Publication Date
EP4251094A1 true EP4251094A1 (fr) 2023-10-04
EP4251094A4 EP4251094A4 (fr) 2024-10-30

Family

ID=87805648

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21899140.4A Pending EP4251094A4 (fr) 2020-11-25 2021-11-24 Dispositif de transcathéter pour traiter la régurgitation de la valve tricuspide mitrale

Country Status (1)

Country Link
EP (1) EP4251094A4 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7901454B2 (en) * 2005-12-15 2011-03-08 The Cleveland Clinic Foundation Apparatus and method for treating a regurgitant valve
WO2013016618A2 (fr) * 2011-07-27 2013-01-31 The Cleveland Clinic Foundation Appareil, système et méthode de traitement d'une régurgitation de valvule cardiaque
KR102156647B1 (ko) * 2019-01-21 2020-09-16 (주) 타우피엔유메디칼 조립형 삼첨판막 역류증 시술용 기구

Also Published As

Publication number Publication date
EP4251094A4 (fr) 2024-10-30

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