Self-Expandable Medical Instrument for Treating of Defects in a Patient's Heart

• US 20090222076A1
• Filed: 11/02/2006
• Published: 09/03/2009
• Est. Priority Date: 11/04/2005
• Status: Abandoned Application

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JEN.Cardiotec GmbH
• Inventors: Figulla, Hans-Reiner, Ferrari, Markus
• Application Number:
  US12/084,421
• Publication Number:
  US 20090222076A1
• Time in Patent Office: Days
• US Class Current: 623/1.200
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The invention relates to 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) is introducible into the body of a patient in a minimally-invasive procedure using a catheter system (40) and comprises a stent (1) made of a flexible mesh (2) of thin wires or filaments (2′). In order to realize a positioning of medical instrument (100) in the patient'"'"'s heart which is as precise as possible and to securely anchor same there, it is provided for the stent (1) composed of the flexible mesh (2) to exhibit in the expanded state of the medical instrument (100) a distal retention area (10) with a laterally-inverted beaded portion (12) which 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).

Claims

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 during 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) composed 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 connection 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 instrument (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 press 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 instrument (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) exhibits 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 expanded medical instrument (100) than the proximal and distal retention areas (10, 20), and wherein the center area (15) exhibits a length which corresponds approximately 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 configured 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 configured such that the stent (1) with the prosthetic heart valve (30) can be withdrawn back into the catheter system (40) and removable from the body of the patient 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, having 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 configured so as to replace a patient'"'"'s aorta valve, mitral valve, pulmonary valve or tricuspid valve.