Method and apparatus for cold loading articles

• US 20090049675A1
• Filed: 08/25/2008
• Published: 02/26/2009
• Est. Priority Date: 08/24/2007
• Status: Active Grant

• Current Assignee: Machine Solutions, Inc.
• Original Assignee: Machine Solutions, Inc.
• Inventors: Reiss, Paul, Sokel, Justin
• Granted Patent: US 8,256,087 B2
• Time in Patent Office: Days
• US Class Current: 29/505
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/49998 Work holding
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule
• CPC Class Codes: Y10T 29/53996 by deforming

Abstract

A method of loading an article, such as a self-expanding stent, into a structures such as a delivery catheter, including the steps of chilling the article to a predetermined temperature, reducing article size a predetermined amount, inserting fluid into the article, whereby the fluid forms a substantially solid plug with respect to the article, and moving the frozen article. Also provided is an apparatus for loading an article into a structure including: an article size reduction element, a chiller connected to the size reduction element, a cold source communicatively connected to the chiller, and a fluid supply communicatively connected to the size reduction element.

Claims

1. A method of processing an article or apparatus comprising the steps of applying a frozen support matrix to at least a portion of the article or apparatus;

processing the supported article or apparatus; and

removing the frozen matrix from the article or apparatus.

2. A method of processing an article or apparatus comprising the steps of:

a. applying a frozen matrix to at least a portion of the article or apparatus;

b. processing the matrix applied article or apparatus, whereby during processing, the article or apparatus is supported by the matrix; and

c. removing the matrix from the article or apparatus after processing.

3. The method of claim 2, wherein the article or apparatus is fragile.

4. The method of claim 2, wherein the article or apparatus has plural shape states.

5. The method of claim 2, wherein the article or apparatus is a self-expanding stent having a predetermined expanded diameter and which is radially compressible to a diameter less than that of the expanded diameter.

6. The method of claim 5, wherein the self-expanding stent has a predetermined length which is greater than 100 mm.

7. The method of claim 2, wherein the step of applying a frozen support matrix to at least a portion of the article or apparatus comprises the steps of providing the article or apparatus, cooling the article or apparatus to a predetermined temperature;

and applying a fluid to the article or apparatus, the fluid freezing at or below the predetermined temperature.

8. The method of claim 7, wherein the article or apparatus has at least first and second shape states, and wherein the article or apparatus is provided at a first shape state, and wherein the article or apparatus changes or seeks to change to the second shape state after removing the frozen matrix from the article or apparatus;

9. The method of claim 8 wherein the article or apparatus is a self-expanding stent having a predetermined expanded-diameter and which is radially compressible to a diameter less than that of the expanded diameter, and wherein the stent is provided compressed, at a diameter less than its expanded diameter;

and wherein the stent seeks to change to its expanded diameter after removing the frozen matrix from the stent.

10. The method of claim 7, further comprising at least of step of pre-processing the article or apparatus before the step of providing the article or apparatus.

11. The method of claim 10, wherein a step of pre-processing is compressing the article or apparatus.

12. The method of claim 11, wherein compressing is crimping.

13. The method of claim 7, wherein the step of cooling comprises contacting the article or apparatus with one or more cooled surfaces for a predetermined time.

14. The method of claim 13, wherein the cooled surfaces are part of a crimper and further comprising the step of crimping the article or apparatus.

15. The method of claim 14, wherein the step of crimping is accomplished before fully cooling the article or apparatus.

16. The method of claim 7, wherein the step of applying a fluid to the article or apparatus, involves applying a gas to the article or apparatus after the article or apparatus is cooled to the predetermined temperature.

17. The method of claim 16, wherein the gas is CO₂ and the predetermined temperature is equal to or less than minus 78.5 C, and wherein the matrix comprises frozen CO₂.

18. The method of claim 16, wherein the article or apparatus is a self-expanding stent and wherein the stent is embedded in the matrix.

19. The method of claim 2, wherein the step of processing the article or apparatus includes the step of inserting the article or mechanism into a confined space.

20. The method of claim 19, wherein the article or apparatus is a self-expanding stent having a predetermined expanded diameter and wherein the step of inserting the stent into a confined space involves pushing the stent into a stent deployment catheter lumen having a diameter less than that of the expanded diameter of the stent.

21. The method of claim 2, wherein the step of removing the matrix from the article or apparatus after processing is accomplished by sublimation.

22. The method of claim 2 for loading a self-expanding stent into a deployment catheter:

i. further comprising the step of compressing the stent to a diameter less than the diameter of the deployment catheter lumen;

ii. wherein the step of applying a frozen support matrix to at least a portion of the article or apparatus comprises the steps of;

cooling the stent to at least minus 78.5 C and applying CO2 gas to the stent, whereby the CO2 gas freezes to form the matrix embedding the stent;

iii. wherein the step of processing the stent includes the step of pushing the supported stent into the stent deployment catheter lumen; and

iv. wherein the step of removing the matrix from the inserted stent is accomplished by sublimation.

23. A method of loading a self-expanding stent into a deployment catheter, comprising the steps of:

a. compressing the stent to a diameter less than the diameter of the lumen of the deployment catheter;

b. applying a support matrix to the stent by cooling the stent to a predetermined cold temperature and applying a fluid to the stent, whereby the fluid freezes to form the matrix embedding the stent;

c. pushing the stent and matrix into the stent deployment catheter lumen; and

d. a removing the matrix from the inserted stent by sublimation.