Catheter system for introducing an expandable heart valve stent into the body of a patient, insertion system with a catheter system and medical device for treatment of a heart valve defect

Patent metadata

Field	Value
Publication number	US-11278406-B2
Application number	US-201615222641-A
Country	US
Kind code	B2
Filing date	Jul 28, 2016
Priority date	May 20, 2010
Publication date	Mar 22, 2022
Grant date	Mar 22, 2022

Abstract

The invention relates to catheter system for introducing an expandable heart valve stent (150) into the body of a patient, the catheter system comprising: a catheter tip (10) having a seat portion for accommodating the stent (150) in its collapsed state and a stent holder (15) for releasably fixing the stent (150), wherein the seat portion is constituted by a first sleeve-shaped member (11) and a second sleeve-shaped member (21), said sleeve-shaped members (11, 21) being moveable relative to each other and relative to the stent holder (15), and a catheter shaft (30) for connecting the catheter tip (10) to a handle (70). The catheter shaft (30) comprising: first force transmitting means (31) connected to the first sleeve-shaped member (11), second force transmitting means (41) connected to the second sleeve-shaped member (21) and a distal end section connectable to second operating means (81) of the handle (70), and guiding means (51) having a passageway extending there between, wherein the first and second force transmitting means (31, 41) are at least partly received within the passageway such as to be moveable relative to the guiding means (51), and wherein the proximal end of the guiding means (51) terminates distal to the catheter tip (10).

First claim

The invention claimed is:

1. A catheter system for introducing an expandable heart valve stent into a body of a patient, the system comprising:
a catheter tube comprising a proximal portion having a first outer diameter and a distal portion having a second outer diameter greater than the first outer diameter, the catheter tube having a flared section located between the proximal portion and the distal portion;
a catheter tip at a distal end of the catheter tube, the catheter tip comprising a stent holder configured to hold the expandable heart valve stent in a collapsed state within the catheter tip and within the catheter tube, the catheter tube being movable relative to the stent holder; and
a guiding tube having a distal end with a third outer diameter greater than the first outer diameter, the guiding tube extending coaxially with at least a portion of the proximal portion of the catheter tube and being moveable relative to the catheter tube to a position at which the distal end of the guiding tube abuts the flared section of the catheter tube, wherein the third outer diameter is substantially equal to the second outer diameter such that a substantially smooth transition is provided between the catheter tube and the guiding tube when the guiding tube is in the position at which the distal end of the guiding tube abuts the flared section of the catheter tube.

2. The system of claim 1 , wherein at least a part of the distal portion of the catheter tube at least partially covers a space configured to contain the expandable heart valve stent in the collapsed state when the expandable heart valve stent is held by the stent holder.

3. The system of claim 1 , wherein the distal portion of the catheter tube forms a first sleeve member, and further comprising a second sleeve member, wherein the first and second sleeve members are moveable relative to each other and relative to the stent holder.

4. The system of claim 3 , wherein the second sleeve member is configured to overlap and move telescopically relative to the first sleeve member.

5. The system of claim 3 , wherein the proximal portion of the catheter tube is connected to the first sleeve member.

6. The system of claim 5 , further comprising a tubular member disposed concentrically within the proximal portion of the catheter tube, wherein the tubular member is connected to the second sleeve member.

7. The system of claim 6 , wherein the tubular member is concentric with and passes through the stent holder.

8. The system of claim 1 , wherein the guiding tube tapers toward the distal end of the guiding tube.

9. The system of claim 1 , wherein a length of the flared section is greater than a length of the expandable heart valve stent in the collapsed state when held by the stent holder.

10. A system for inserting an expandable heart valve stent, the system comprising:
a catheter tip comprising a stent holder and a sleeve member disposed around and movable relative to the stent holder, the stent holder configured to releasably hold an expandable heart valve stent in a collapsed position within the catheter tip and within the sleeve member, wherein the sleeve member has a tapered section tapering in a proximal direction such that a proximal portion of the sleeve member has a smaller outer diameter than a distal portion of the sleeve member; and
a guiding tube concentrically disposed around at least a portion of the proximal portion of the sleeve member and moveable relative to the proximal portion of the sleeve member to a position at which a distal end of the guiding tube abuts the tapered section of the sleeve member,
wherein, when the guiding tube is in the position at which the distal end of the guiding tube abuts the tapered section, a smooth transition is provided between the sleeve member and the guiding tube.

11. The system of claim 10 , wherein the sleeve member at least partially covers a space configured to contain the expandable heart valve stent in the collapsed position, when the expandable heart valve stent is held by the stent holder.

12. The system of claim 10 , wherein the sleeve member is a first sleeve member, and the system further comprises a second sleeve member, wherein the first and second sleeve members are moveable relative to each other and relative to the stent holder.

13. The system of claim 12 , wherein the second sleeve member is telescopically movable relative to the first sleeve member.

14. The system of claim 12 , further comprising a catheter handle comprising a first operating mechanism, the first operating mechanism being connected to a proximal end of the proximal portion of the first sleeve member.

15. The system of claim 14 , wherein the guiding tube is releasably connected to the catheter handle.

16. The system of claim 14 , wherein the catheter handle further comprises a second operating mechanism.

17. The system of claim 16 , further comprising a tubular member disposed concentrically within the proximal portion of the first sleeve member, wherein a distal end of the tubular member is connected to the second sleeve member and a proximal end of the tubular member is connected to the second operating mechanism.

18. The system of claim 17 , wherein a length of the proximal portion of the first sleeve member is substantially the same as a length of the tubular member.

19. The system of claim 18 , wherein a length of the guiding tube is less than the length of the first sleeve member and is less than the length of the tubular member.

20. The system of claim 10 , wherein an outer diameter of the guiding tube is substantially the same as an outer diameter of a distal portion of the sleeve member.

21. The system of claim 10 , wherein the distal end of the guiding tube is tapered such that it abuts the tapered section of the sleeve member.

22. The system of claim 10 , wherein a length of the tapered section is greater than a length of the expandable heart valve stent in the collapsed position when held by the stent holder.

23. A system for inserting an expandable heart valve stent into a patient's body, the system comprising:
a catheter tip comprising a stent holder and a sleeve member disposed around the stent holder, the stent holder configured to releasably hold the expandable heart valve stent in a collapsed position within the catheter tip and the sleeve member, wherein the sleeve member is movable relative to the stent holder, and wherein a distal portion of the sleeve member transitions to a proximal portion of the sleeve member via a tapered section of the sleeve member;
a catheter handle comprising a first operating mechanism, the first operating mechanism being operatively connected to a proximal end of the sleeve member; and
a guiding tube concentrically disposed around at least a portion of the proximal portion of the sleeve member and being moveable relative to the proximal portion of the sleeve member and the catheter handle to a position at which a distal end of the guiding tube abuts the tapered section of the sleeve member,
wherein, when the guiding tube is in the position at which the distal end of the guiding tube abuts the tapered section, a smooth transition is provided between the sleeve member and the guiding tube.

24. The system of claim 23 , wherein the guiding tube is releasably connected to the catheter handle.

25. The system of claim 23 , wherein an outer diameter of the guiding tube is substantially the same a

Assignees

• Jenavalve Tech Inc

Inventors

• Straubinger Helmut
• Mayer Arnulf
• Jung Johannes

Classifications

• A61F2002/9505

  having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title