CA2627555A1 - Self-expandable medical instrument for treating defects in a patient's heart - Google Patents

Self-expandable medical instrument for treating defects in a patient's heart Download PDF

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Publication number
CA2627555A1
CA2627555A1 CA002627555A CA2627555A CA2627555A1 CA 2627555 A1 CA2627555 A1 CA 2627555A1 CA 002627555 A CA002627555 A CA 002627555A CA 2627555 A CA2627555 A CA 2627555A CA 2627555 A1 CA2627555 A1 CA 2627555A1
Authority
CA
Canada
Prior art keywords
medical instrument
stent
heart valve
mesh
self
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.)
Granted
Application number
CA002627555A
Other languages
French (fr)
Other versions
CA2627555C (en
Inventor
Hans-Reiner Figulla
Markus Ferrari
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.)
Jenavalve Technology Inc
Original Assignee
Jenavalve Technology Inc.
Hans-Reiner Figulla
Markus Ferrari
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 Jenavalve Technology Inc., Hans-Reiner Figulla, Markus Ferrari filed Critical Jenavalve Technology Inc.
Publication of CA2627555A1 publication Critical patent/CA2627555A1/en
Application granted granted Critical
Publication of CA2627555C publication Critical patent/CA2627555C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61F2/2412—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
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • 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
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • 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
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal
    • 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
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal

Abstract

The invention relates to a self-expandable medical instrument (100) for treatment of defects on a patient~s heart, in particular for vascular implantation of a heart-valve prosthesis (30), which medical instrument (100) can be introduced into a patient~s body by a minimally invasive approach using a catheter system (40) and comprises a stent (1) made up of a flexible lattice (2) of thin wires or filaments (2~). To ensure that the medical instrument (100) can be positioned as accurately as possible in the patient~s heart and can be safely secured there, provision is made that, in the expanded state of the medical instrument (100), the stent (1) made up of the flexible lattice (2) comprises a distal retention area (10) with a laterally outwardly protruding bead portion (12) that can be brought into engagement with at least one pocket (51) of the defective heart valve (50) of the patient, and also comprises a proximal retention area (20) and, between the distal and proximal retention areas (10, 20), a middle area (15).

Claims (17)

1. A self-expandable medical instrument (100) for treating defects in a patient's heart, in particular for the transvascular implantation of a prosthetic heart valve (30), wherein the medical instrument (100) can be introduced into the body of a patient in a minimally-invasive procedure using a catheter system (40) and comprises a stent (1) made from a flexible mesh (2) of thin wires or filaments (2'), wherein the stent (1) configured from flexible mesh (2) exhibits a first predefinable shape dur-ing the insertion of the medical instrument (100) in the patient's body and a second predefinable shape in the implanted state of the medical instrument (100), wherein said medical instrument (100) is in a collapsed state in the first shape of the stent (1) composed of the flexible mesh (2) and in an expanded state in the second shape of the stent (1) composed of the flexible mesh (2), and wherein the stent (1) com-posed of the flexible mesh (2) in its second predefinable shape and in the expanded state of the medical instrument (100) exhibits the following:

- a distal retention area (10) having a laterally-inverted beaded portion (12), which in the implanted state of the medical instrument (100) is engageable in at least one pocket (51) of the patient's defective heart valve (50);

- a proximal retention area (20); and - a center area (15) positioned between the distal and the proximal retention area (10, 20), wherein the center area (15) of the stent (1) of the expanded medical instrument (100) exhibits a smaller diameter than the proximal and/or distal retention area (10, 20), and wherein the center area (15) is configured to form a positive connec-tion with the vascular wall (52) at the height of the defective heart valve (50) in the implanted state of the medical instrument (100).
2. The self-expandable medical instrument (100) according to claim 1, wherein the stent (1) further exhibits a self-expandable prosthetic heart valve (30) disposed in the center area (15) which self-expands upon the medical instrument (100) being released from the catheter system (40).
3. The medical instrument (100) according to claim 1 or 2, wherein the mesh (2) is a mesh tube, and wherein the medical instrument (100) exhibits a form open to the proximal and distal end in its expanded state.
4. The medical instrument (100) according to any one of the preceding claims, wherein the beaded portion (12) at the distal retention area (10) of stent (1) in the expanded medical instrument (100) is formed by the mushroom-shaped outwardly turning back of the distal end of mesh (2).
5. The medical instrument (100) according to claim 4, wherein the beaded portion (12) at the distal retention area (10) of stent (1) in the expanded medical instru-ment (100) in the implanted state is invertible into at least one pocket (51) of the patient's defective heart valve (50) and thus serves as a means for positioning the medical instrument (100) at the height of the patient's defective heart valve (50).
6. The medical instrument (100) according to any one of the preceding claims, wherein based upon the self-expanding properties of the mesh (2), the proximal retention area (20) of the stent (1) in the expanded medical instrument (100) is configured so as to form a force-fit connection with the vascular wall (52) in the direct proximity of the defective heart valve (50) in the implanted state of the medical instrument (100).
7. The medical instrument (100) according to any one of the preceding claims, wherein based upon the self-expanding properties of the mesh (2), the center area (15) of the stent (1) in the expanded medical instrument (100) is configured so as to pi-ess the patient's defective heart valve (50) against the vascular wall (52) distal the defective heart valve (50) in the implanted state of the medical instru-ment (100).
8. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) in the expanded state of the medical instrument (100) exhib-its a shape similar to a barbell.
9. The medical instrument (100) according to any one of the preceding claims, wherein the center area (15) of the stent (1) exhibits a smaller diameter in the ex-panded medical instrument (100) than the proximal and distal retention areas (10, 20), and wherein the center area (15) exhibits a length which corresponds ap-proximately to the length of the defective heart valve (50).
10. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) made of mesh (2) with a self-expandable prosthetic heart valve (30) arranged at its center area (15) tapers to the diameter of the catheter system (40) used in the transvascular surgical procedure.
11. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) exhibits a mounting (4) engageable with an explantation catheter system (40) on its proximal and/or distal end, and wherein the medical instrument (100) is configured such that an external manipulation will effect its commuting from its expanded state into its collapsed state.
12. The medical instrument (100) according to any one of the preceding claims, wherein in the implanted state of the expanded medical instrument (100), the flexible mesh (2), in particular wire mesh, of stent (1) is disposed in multi-layered arrangement around the defective heart valve (50).
13. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) made of flexible mesh (2), in particular wire mesh, having a self-expandable prosthetic heart valve (30) arranged at its center area (15) is con-figured such that the second shape of stent (1) is adaptable in such a manner to the anatomical conditions so as to achieve on the one hand a maximum expansion of prosthetic heart valve (30) and, on the other, an optimum lateral sealing to the vascular wall (52) in the implanted state of the expanded medical instrument (100).
14. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) made from flexible mesh (2), in particular wire mesh, having a self-expandable prosthetic heart valve (30) arranged at its center area (15) is con-figured such that the stent (1) with the prosthetic heart valve (30) can be with-drawn back into the catheter system (40) and removable from the bod), of the pa-tient at any time during the implantation of the medical instrument (100).
15. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) made from flexible mesh (2), in particular wire mesh, hav-ing a self-expandable prosthetic heart valve (30) arranged at its center area (15) is configured such that using a catheter system (40) and guide wires (41), the stent (1) with the prosthetic heart valve (30) is again retractable and explantable following a successful release.
16. The medical instrument (100) according to any one of the preceding claims, wherein the flexible mesh (2) is made from a material having memory effect, in particular nitinol or memory plastics.
17. The medical instrument (100) according to any one of the preceding claims, wherein the stent (1) made from flexible mesh (2), in particular wire mesh, having a self-expandable prosthetic heart valve (30) arranged at its center area (15) is con-figured so as to replace a patient's aorta valve, mitral valve, pulmonary valve or tricuspid valve.
CA2627555A 2005-11-04 2006-11-02 Self-expandable medical instrument for treating defects in a patient's heart Expired - Fee Related CA2627555C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102005052628.4A DE102005052628B4 (en) 2005-11-04 2005-11-04 Self-expanding, flexible wire mesh with integrated valvular prosthesis for the transvascular heart valve replacement and a system with such a device and a delivery catheter
DE102005052628.4 2005-11-04
PCT/EP2006/010519 WO2007051620A1 (en) 2005-11-04 2006-11-02 Self-expandable medical instrument for treatment of defects on a patient’s heart

Publications (2)

Publication Number Publication Date
CA2627555A1 true CA2627555A1 (en) 2007-05-10
CA2627555C CA2627555C (en) 2011-04-05

Family

ID=37714361

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2627555A Expired - Fee Related CA2627555C (en) 2005-11-04 2006-11-02 Self-expandable medical instrument for treating defects in a patient's heart

Country Status (12)

Country Link
US (2) US20090222076A1 (en)
EP (1) EP1942834B1 (en)
JP (1) JP4904362B2 (en)
AU (1) AU2006310681B2 (en)
CA (1) CA2627555C (en)
DE (1) DE102005052628B4 (en)
DK (1) DK1942834T3 (en)
ES (1) ES2401451T3 (en)
PL (1) PL1942834T3 (en)
PT (1) PT1942834E (en)
SI (1) SI1942834T1 (en)
WO (1) WO2007051620A1 (en)

Cited By (18)

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US20090222076A1 (en) 2009-09-03
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