Minimally-invasive delivery systems

• US 10,426,614 B2
• Filed: 02/20/2018
• Issued: 10/01/2019
• Est. Priority Date: 08/01/2016
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Harari, Boaz, Karalnik, Maxim, Albitov, Michael, Iamberger, Meni
• Primary Examiner(s): David, Shaun L
• Application Number:
  US15/899,858
• Publication Number:
  US 20180185148A1
• Time in Patent Office: 588 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A tool is configured for transluminal delivery of an implant. The tool has a proximal part and a distal part, and comprises a shaft, a nosepiece, a sheath, and a balloon. The nosepiece is fixed to the shaft, and is arranged with respect to the implant such that the implant extends proximally away from the nosepiece and over the shaft. The sheath houses the implant. The balloon is disposed at the distal part of the tool, and is in fluid communication with the proximal part of the tool. When maximally inflated, the balloon has (i) a widest part that has an inflated diameter that is less than the diameter of the sheath or at most 10 percent greater than the diameter of the sheath, and (ii) a tapered portion that tapers longitudinally away from the widest part and from the nosepiece.

Claims

1. Apparatus, comprising:

an implant;

comprising (i) a frame that defines a central longitudinal lumen, and (ii) prosthetic valve leaflets disposed within the lumen,

constrainable, by a constraining force, in a compressed state in which the lumen has a compressed internal diameter,

having an expanded state into which the implant automatically transitions upon removal of the constraining force, and in which the lumen has an expanded internal diameter; and

a tool, configured for transluminal delivery of the implant, the tool comprising;

a shaft that extends longitudinally from a proximal part of the tool;

a nosepiece fixed to the shaft, and arranged with respect to the implant such that the implant extends proximally away from the nosepiece and over the shaft; and

a balloon, in fluid communication with the proximal part of the tool,

wherein;

the balloon has;

a maximally-inflated state in which the balloon (i) has a widest part that has an inflated external diameter that is smaller than the expanded internal diameter, (ii) has a tapered portion that tapers longitudinally away from the widest part and from the nosepiece, and (iii) is dimensioned such that, while the implant is in its expanded state, the balloon is withdrawable by sliding of the balloon through the lumen, between the leaflets, and out of the lumen, and

a deflated state in which the widest part has a deflated external diameter that is smaller than the inflated external diameter, and

the apparatus has a delivery state in which;

the implant is in the compressed state,

the balloon is in the deflated state, and

a portion of the balloon is disposed within the lumen.

2. The apparatus according to claim 1, wherein the nosepiece is fixed to the distal end of the shaft.

3. The apparatus according to claim 1, wherein the tapered portion tapers proximally away from the widest part and from the nosepiece.

4. The apparatus according to claim 1, wherein:

the nosepiece is arranged with respect to the implant such that the implant extends proximally over the shaft with the shaft within the lumen of the implant,

the implant assumes the expanded state upon implantation of the implant, and

the nosepiece is dimensioned to be withdrawable proximally through the lumen while the implant is in its expanded state.

5. The apparatus according to claim 4, wherein the nosepiece is not dimensioned to be withdrawable proximally through the lumen while the implant is in its compressed state.

6. The apparatus according to claim 1, wherein:

the tool further comprises a sheath that has a diameter that is dimensioned for transluminal delivery, and

in the delivery state, the sheath houses the implant.

7. Apparatus, comprising:

an implant;

comprising (i) a frame that defines a central longitudinal lumen, and (ii) prosthetic valve leaflets disposed within the lumen,

constrainable, by a constraining force, in a compressed state in which the lumen has a compressed internal diameter,

having an expanded state into which the implant automatically transitions upon removal of the constraining force, and in which the lumen has an expanded internal diameter; and

a tool, configured for transluminal delivery of the implant, the tool comprising;

a shaft that extends longitudinally from a proximal part of the tool;

a nosepiece fixed to the shaft, and arranged with respect to the implant such that the implant extends proximally away from the nosepiece and over the shaft; and

a balloon, in fluid communication with the proximal part of the tool,

wherein;

the balloon has;

a maximally-inflated state in which the balloon (i) has a widest part that has an inflated external diameter that is less than 90 percent of the expanded internal diameter, and (ii) has a tapered portion that tapers longitudinally away from the widest part and from the nosepiece, and

a deflated state in which the widest part has a deflated external diameter that is smaller than the inflated external diameter, and

the apparatus has a delivery state in which;

the implant is in the compressed state,

the balloon is in the deflated state, and

a portion of the balloon is disposed within the lumen.

8. The apparatus according to claim 7, wherein the nosepiece is fixed to the distal end of the shaft.

9. The apparatus according to claim 7, wherein the tapered portion tapers proximally away from the widest part and from the nosepiece.

10. The apparatus according to claim 7, wherein:

the nosepiece is arranged with respect to the implant such that the implant extends proximally over the shaft with the shaft within the lumen of the implant,

the implant assumes the expanded state upon implantation of the implant, and

the nosepiece is dimensioned to be withdrawable proximally through the lumen while the implant is in its expanded state.

11. The apparatus according to claim 10, wherein the nosepiece is not dimensioned to be withdrawable proximally through the lumen while the implant is in its compressed state.

12. The apparatus according to claim 7, wherein:

the tool further comprises a sheath that has a diameter that is dimensioned for transluminal delivery, and

in the delivery state, the sheath houses the implant.

13. Apparatus, comprising:

an implant;

comprising (i) a frame that defines a central longitudinal lumen, and (ii) a valve member disposed within the lumen,

constrainable, by a constraining force, in a compressed state in which the lumen has a compressed internal diameter,

having an expanded state into which the implant automatically transitions upon removal of the constraining force, and in which the lumen has an expanded internal diameter; and

a tool, configured for transluminal delivery of the implant, the tool comprising;

a shaft that extends longitudinally from a proximal part of the tool;

a nosepiece fixed to the shaft, and arranged with respect to the implant such that the implant extends proximally away from the nosepiece and over the shaft; and

a balloon, in fluid communication with the proximal part of the tool,

wherein;

the balloon has;

a maximally-inflated state in which the balloon (i) has a widest part that has an inflated external diameter that is smaller than the expanded internal diameter and can fit through the valve member, (ii) has a tapered portion that tapers longitudinally away from the widest part and from the nosepiece, and

a deflated state in which the widest part has a deflated external diameter that is smaller than the inflated external diameter, and

the apparatus has a delivery state in which;

the implant is in the compressed state,

the balloon is in the deflated state, and

a portion of the balloon is disposed within the lumen.

14. The apparatus according to claim 13, wherein the nosepiece is fixed to the distal end of the shaft.

15. The apparatus according to claim 13, wherein the tapered portion tapers proximally away from the widest part and from the nosepiece.

16. The apparatus according to claim 13, wherein:

the nosepiece is arranged with respect to the implant such that the implant extends proximally over the shaft with the shaft within the lumen of the implant,

the implant assumes the expanded state upon implantation of the implant, and

the nosepiece is dimensioned to be withdrawable proximally through the lumen while the implant is in its expanded state.

17. The apparatus according to claim 16, wherein the nosepiece is not dimensioned to be withdrawable proximally through the lumen while the implant is in its compressed state.

18. The apparatus according to claim 13, wherein:

the tool further comprises a sheath that has a diameter that is dimensioned for transluminal delivery, and

in the delivery state, the sheath houses the implant.