Electrospun medical devices and methods of making electrospun medical devices

Patent metadata

Field	Value
Publication number	US-12201516-B2
Application number	US-201916519738-A
Country	US
Kind code	B2
Filing date	Jul 23, 2019
Priority date	Jul 23, 2018
Publication date	Jan 21, 2025
Grant date	Jan 21, 2025

Abstract

A method of forming an electrospun prosthetic valve includes utilizing a rotatable and angularly adjustable prosthetic valve mold. The prosthetic valve mold is set to a first angle. The prosthetic valve mold is rotated at a first rotational velocity and a first layer of electrospun fibers is deposited on the prosthetic valve mold. The prosthetic valve mold is stopped and a frame is positioned over the first layer. The prosthetic valve mold is set to a second angle. The prosthetic valve mold is rotated at a second velocity and a second layer of electrospun fibers is deposited on an outer surface of the first layer and an outer surface of the frame.

First claim

What is claimed is:

1. A method of forming an electrospun prosthetic valve, the method comprising the steps of:
angularly adjusting a prosthetic valve mold to a first angle, the valve mold coupled to a first portion of a bracket, and a base coupled to a second portion of the bracket such that angularly adjusting the prosthetic valve mold comprises angularly adjusting the first portion of the bracket relative to the second portion of the bracket, the bracket comprising a locking mechanism operable between an unlocked configuration and a locked configuration, wherein in the unlocked conguration, the first portion of the bracket is angularly adjustable relative to the second portion of the bracket about a pivot joint to change the first angle between the valve mold and the base within a range between 0 degrees to 180 degrees, and in the locked configuration, the first portion of the bracket is non-movable relative to the second portion of the bracket,
rotating the prosthetic valve mold at a first rotational velocity;
depositing a first layer of a first plurality of electrospun fibers onto the prosthetic valve mold;
stopping the rotation of the prosthetic valve mold from the first rotational velocity;
positioning a frame radially outward of the first layer;
rotating the prosthetic valve mold including the first layer and the frame at a second rotational velocity;
depositing a second layer of a second plurality of electrospun fibers onto an outer surface of the frame and an outer surface of the first layer;
stopping the rotation of the prosthetic valve mold, and
processing the precursor electrospun prosthetic valve to form the electrospun prosthetic valve.

2. The method of forming the electrospun prosthetic valve of claim 1 , further including the step of angularly adjusting the prosthetic valve mold to a second angle after the step of stopping the rotation of the prosthetic valve mold from the first rotational velocity, and before rotating the prosthetic valve mold at a second rotational velocity.

3. The method of forming the electrospun prosthetic valve of claim 1 , further including the step of coupling the second layer to the first layer with one of an induction heater or a bonding solvent.

4. The method of forming the electrospun prosthetic valve of claim 3 , wherein a bonding solvent is applied to the outer surface of the first layer after the step of positioning the frame over the first layer of the prosthetic valve and before the step of depositing the second layer of the second plurality of electrospun fibers onto the frame and the first layer.

5. The method of forming the electrospun prosthetic valve of claim 1 , wherein the step of depositing the second layer includes depositing electrospun fibers having an area of increased thickness with respect to other regions of the second layer, the area of increased thickness extending around a circumference of the frame such that the second layer comprises a non-uniform diameter along a length of the prosthetic valve with the area of increased thickness comprising a larger diameter than the other regions of the second layer.

6. The method of forming the electrospun prosthetic valve of claim 1 , comprising vapor depositing parylene on the frame.

7. The method of forming the electrospun prosthetic valve of claim 1 , wherein the prosthetic valve mold is rotatable in the range of 0-1,000 revolutions per minute.

8. The method of forming the electrospun prosthetic valve of claim 1 , wherein the prosthetic valve mold extends along a first longitudinal axis, and a second longitudinal axis extends through the pivot point and parallel to a collection base, the first angle defined between the first longitudinal axis and the second longitudinal axis and adjustable within the range between 0 degrees to 180 degrees.

9. The method of forming the electrospun prosthetic valve of claim 1 , wherein the angular adjustment of the prosthetic valve mold is configured to enable an even distribution of the first or the second pluralities of electrospun fibers during deposition thereon, further wherein the prosthetic valve mold is coupled to a motor that rotates the prosthetic valve mold at the first rotational velocity and the second rotational velocity, the motor coupled to the first portion of the bracket such that the motor and the valve mold are angularly adjusted relative to the base.

10. The method of forming the electrospun prosthetic valve of claim 1 , further including the steps of heating a first portion of the prosthetic valve mold to melt a corresponding selected portion of the first and second layers of the electrospun prosthetic valve, and then cooling the electrospun prosthetic valve to crystalize and strengthen the selected portion of the precursor electrospun prosthetic valve prior to the step of processing the precursor electrospun prosthetic valve.

11. The method of forming the electrospun prosthetic valve of claim 10 , wherein the first portion of the prosthetic valve mold is a plurality of first portions.

12. The method of claim 1 , wherein the prosthetic valve mold comprises a plurality of segments removably attached to a mold base, the plurality of segments comprising stems that each project outwardly from leaflet portions of the plurality of segments, and wherein the stems are configured to be received within stem openings of the mold base, and wherein the plurality of segments are shaped to form a corresponding leaflet of the first layer of the first plurality of electrospun fibers.

13. A method of forming an electrospun prosthetic valve, the method comprising the steps of:
angularly adjusting a prosthetic valve mold to a first angle, the prosthetic valve mold extending between a first end and a second end, the second end coupled to a motor;
rotating the prosthetic valve mold at a first rotational velocity;
depositing a first layer of a first plurality of electrospun fibers onto the prosthetic valve mold such that the first layer covers the first end of the prosthetic valve mold, the prosthetic valve mold comprising a plurality of separate segments extending between a first end and a second end, with the second end of each of the plurality of separate segments comprising stems that project outwardly and are removably attached to a mold base and the first end comprising one or more channels, and wherein each segment of the plurality of segments is shaped to form a corresponding leaflet of the first layer of the first plurality of electrospun fibers and the one or more channels forms a corresponding channel of the first layer of the first plurality of electrospun fibers,
stopping the rotation of the prosthetic valve mold from the first rotational velocity;
positioning a frame radially outward of the first layer such that all of the first layer is received within a lumen of the frame that extends between an inflow end and an outflow end of the frame, the inflow end adjacent to the second end of the prosthetic valve mold;
rotating the prosthetic valve mold including the first layer and the frame at a second rotational velocity;
depositing a second layer of a second plurality of electrospun fibers onto an outer surface of the frame and an outer surface of the first layer;
stopping the rotation of the prosthetic valve mold, and
processing the precursor electrospun prosthetic valve to form the electrospun prosthetic valve.

Assignees

• Medtronic Inc

Inventors

• Karciauskas Evaldas
• Avelar Salvador
• Grodrian Todd
• Krivoruchko Mike
• Chen Mingfei
• Storment Christopher
• Shumaker David A
• Wegner Mark M
• Traina Joseph A

Classifications

• D01D5/0076

  characterised by the collecting device, e.g. drum, wheel, endless belt, plate or grid (D01D5/0046 takes precedence) · CPC title

• B29C37/0053

  Moulding articles characterised by the shape of the surface, e.g. ribs, high polish (mould construction therefor B29C33/42; surface shaping of articles B29C59/00; by incorporating filler in or near the surface B29C70/64) · CPC title

• B29C35/16

  Cooling {(cooling extruded material B29C48/911; cooling preforms for blow moulding B29C49/6427; cooling blown articles B29C49/66; cooling tyres during post cure inflation B29D30/0643)} · CPC title

• B29C35/02

  Heating or curing, e.g. crosslinking or vulcanizing {during moulding, e.g. in a mould}(cold vulcanisation B29C35/18 {; vulcanising tyres, presses therefor B29D30/0601}) · CPC title

• B29C33/42

  characterised by the shape of the moulding surface, e.g. ribs or grooves · CPC title