US-12622781-B2 - Tissue based bioprosthetic heart valve

Abstract

Embodiments herein relate to bioprosthetic heart valves. In an embodiment, a heart valve replacement system is included having a delivery catheter can include a heart valve accommodation region; and a heart valve disposed around the delivery catheter at the heart valve accommodation region of the delivery catheter, the heart valve can include a frame; and a plurality of valve leaflets coupled to the frame; wherein the valve leaflets include an animal tissue, the animal tissue can include from 15% to 50% by weight water; and from 20% to 70% by weight glycerol; a package defining an interior volume, wherein the delivery catheter and the heart valve are disposed within the package. Other embodiments are also included herein.

Inventors

• Arnaud Humair

Assignees

• BOSTON SCIENTIFIC LIMITED

Dates

Publication Date

20260512

Application Date

20220920

Claims (20)

1. 1 . A method of making a heart valve replacement device comprising: cutting animal tissue into leaflets; coupling the leaflets to a frame to form a heart valve; contacting the leaflets with a composition comprising glycerol; removing moisture from the leaflets in an environment at above room temperature and/or below atmospheric pressure; and placing the heart valve on a delivery catheter; wherein coupling the leaflets to the frame occurs prior to removing moisture from the leaflets in the environment at above room temperature and/or below atmospheric pressure; wherein the leaflets of the heart valve are glutaraldehyde-free when placed on the delivery catheter.
2. 2 . The method of claim 1 , wherein the composition comprises at least 50% glycerol by weight.
3. 3 . The method of claim 2 , wherein the composition comprises no more than 98% glycerol by weight.
4. 4 . The method of claim 3 , wherein the composition comprises at least 70% glycerol by weight.
5. 5 . The method of claim 4 , wherein the composition comprises at least 90% glycerol by weight.
6. 6 . The method of claim 2 , wherein the composition comprises glycerol and water.
7. 7 . The method of claim 6 , wherein the composition further comprises sodium.
8. 8 . The method of claim 2 , further comprising at least partially crimping the heart valve onto the delivery catheter.
9. 9 . The method of claim 8 , further comprising packaging the heart valve and the delivery catheter into a package.
10. 10 . The method of claim 1 , wherein the leaflets have a water content of about 15 to 50 wt. % and a glycerol content of about 20 to about 70 wt. % after removing moisture.
11. 11 . The method of claim 1 , further comprising coupling an inner skirt to the frame; contacting the inner skirt with a composition comprising glycerol; removing moisture from the inner skirt in an environment at above room temperature and/or below atmospheric pressure.
12. 12 . The method of claim 11 , further comprising coupling an outer skirt to the frame; contacting the outer skirt with a composition comprising glycerol; removing moisture from the outer skirt in an environment at above room temperature and/or below atmospheric pressure.
13. 13 . The method of claim 1 , further comprising disposing a sheath over the heart valve and at least a portion of the delivery catheter.
14. 14 . The method of claim 13 , wherein an outside waist diameter of the sheath is less than 15 mm.
15. 15 . The method of claim 14 , wherein the sheath has an inner diameter of 18 F or smaller.
16. 16 . The method of claim 13 , further comprising packaging the heart valve, sheath, and the delivery catheter into a package.
17. 17 . The method of claim 1 , wherein the delivery catheter comprises a balloon.
18. 18 . The method of claim 17 , wherein the delivery catheter defines an inflation lumen.
19. 19 . The method of claim 17 , wherein the balloon is distal relative to the heart valve.
20. 20 . The method of claim 1 , wherein the heart valve is an aortic heart valve.

Description

This application is a continuation application of U.S. patent application Ser. No. 17/011,366, filed on Sep. 3, 2020, which claims the benefit of U.S. Provisional Application No. 62/899,405, filed Sep. 12, 2019, the content of which is herein incorporated by reference in its entirety. FIELD Embodiments herein relate to bioprosthetic heart valves. More specifically, embodiments herein relate to percutaneously deliverable bioprosthetic heart valves. BACKGROUND Heart function can be significantly impaired when a heart valve is not functioning properly. Potential causes for heart valve malfunction include dilation of an annulus around the valve, ventricular dilation, a prolapsed or misshapen valve leaflet, and stenosis, such as aortic stenosis. When the heart valve is unable to close properly, the blood within a heart chamber can regurgitate, or leak backwards through the valve. When the heart valve is unable to open properly, forward blood flow (e.g. systolic blood flow) can be impaired. Valve malfunction may be treated by replacing or repairing a diseased valve, such as an aortic valve. Surgical valve replacement is one method for treating the diseased valve. Minimally invasive methods of treatment, such as transcatheter aortic valve replacement (TAVR), generally involve the use of delivery catheters that are delivered through arterial passageways or other anatomical routes into the heart to replace the diseased valve with an implantable prosthetic heart valve. Leaflets of such valves have been formed from various materials including synthetic materials and animal tissues. SUMMARY In a first aspect, a heart valve replacement system is included having a delivery catheter and a heart valve. The delivery catheter can include a heart valve accommodation region. A heart valve can be disposed around the delivery catheter at the heart valve accommodation region of the delivery catheter. The heart valve can include a frame and a plurality of valve leaflets coupled to the frame. The valve leaflets can include an animal tissue. The animal tissue can include from 15% to 50% by weight water; and from 20% to 70% by weight glycerol. The heart valve replacement system can further include a package defining an interior volume. The delivery catheter and the heart valve can be disposed within the package. In a second aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the animal tissue further can include at least about 0.15% by weight of a cation of a salt. The cation can be selected from the group consisting of sodium, potassium, calcium and magnesium. In a third aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, further can include a sheath disposed at least partly over the heart valve. The sheath can have an inner diameter of 18 F or smaller. In a fourth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the heart valve is uncrimped onto the delivery catheter and has an outside waist diameter of greater than 20 mm as disposed around the delivery catheter within the package. In a fifth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the heart valve is partially crimped onto the delivery catheter and has an outside waist diameter of from 19 mm to 10 mm as disposed around the delivery catheter within the package. In a sixth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the heart valve is crimped onto the delivery catheter and has an outside waist diameter of less than 7 mm as disposed around the delivery catheter within the package. In a seventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the animal tissue can include from 15 to 60% by weight glycerol. In an eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the heart valve further can include a skirt, the skirt can include an animal tissue, the animal tissue can include from 15% to 50% by weight water; and from 20% to 70% by weight glycerol. In a ninth aspect, a method of making a heart valve replacement device is included. The method can include cutting animal tissue into leaflets; coupling the leaflets to a frame to form a heart valve; contacting the leaflets with a composition can include glycerol; removing moisture from the leaflets in an environment at above room temperature and/or below atmospheric pressure; and placing the heart valve on a delivery catheter. In a tenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the composition includes a glycerol and water mixture. In an eleventh aspect, in addition to one or more of the preceding or following aspects,