Temperature controlled crimping

• US 20050119720A1
• Filed: 10/01/2004
• Published: 06/02/2005
• Est. Priority Date: 12/01/2003
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated State of Incorporation California
• Inventors: Gale, David C., Huang, Bin, Pacetti, Stephen D., Abbate, Anthony
• Granted Patent: US 8,052,912 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: B29B 13/024 Hollow bodies, e.g. tubes or profiles
• CPC Class Codes: B29C 2035/0822 using IR radiation
• CPC Class Codes: B29C 2071/022 Annealing
• CPC Class Codes: B29C 65/56 using mechanical means or mechanical connections, e.g. form-fits
• CPC Class Codes: B29C 65/76 Making non-permanent or releasable joints
• CPC Class Codes: B29C 66/71 characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73117 Tg, i.e. glass transition temperature
• CPC Class Codes: B29C 66/9121 by measuring the temperature
• CPC Class Codes: B29C 66/91431 the temperature being kept constant over time
• CPC Class Codes: B29C 66/91641 the heat or the thermal flux being non-constant over time
• CPC Class Codes: B29C 66/919 characterised by specific temperature, heat or thermal flux values or ranges specific electrical resistance values B29C66/81262
• CPC Class Codes: B29C 66/91921 in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
• CPC Class Codes: B29C 66/91941 in explicit relation to Tg, i.e. the glass transition temperature, of the material of one of the parts to be joined
• CPC Class Codes: B29C 66/91945 : lower than said glass transition temperature
• CPC Class Codes: B29K 2001/00 : Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
• CPC Class Codes: B29K 2001/12 : Cellulose acetate
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2023/08 : Copolymers of ethylene B29K2023/16 takes precedence
• CPC Class Codes: B29K 2023/083 : EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2023/086 : EVOH, i.e. ethylene vinyl alcohol copolymer
• CPC Class Codes: B29K 2023/18 : Polymers of hydrocarbons having four or more carbon atoms, e.g. polymers of butylene, e.g. PB, i.e. polybutylene
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2027/08 : PVDC, i.e. polyvinylidene chloride
• CPC Class Codes: B29K 2027/16 : PVDF, i.e. polyvinylidene fluoride
• CPC Class Codes: B29K 2029/00 : Use of polyvinylalcohols, polyvinylethers, polyvinylaldehydes, polyvinylketones or polyvinylketals or derivatives thereof as moulding material
• CPC Class Codes: B29K 2031/00 : Use of polyvinylesters or derivatives thereof as moulding material
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2033/12 : Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
• CPC Class Codes: B29K 2033/20 : PAN, i.e. polyacrylonitrile
• CPC Class Codes: B29K 2055/02 : ABS polymers, i.e. acrylonitrile-butadiene-styrene polymers
• CPC Class Codes: B29K 2059/00 : Use of polyacetals , e.g. POM, i.e. polyoxymethylene or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2063/00 : Use of EP, i.e. epoxy resins or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/00 : Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2067/04 : Polyesters derived from hydroxycarboxylic acids
• CPC Class Codes: B29K 2069/00 : Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2071/00 : Use of polyethers , e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 : Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 : Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2079/08 : PI, i.e. polyimides or derivatives thereof
• CPC Class Codes: B29K 2083/00 : Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 29/49865 : by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 428/24942 : including components having same physical characteristic in differing degree
• CPC Class Codes: Y10T 428/3154 : Of fluorinated addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31544 : Addition polymer is perhalogenated
• CPC Class Codes: Y10T 428/31855 : Of addition polymer from unsaturated monomers

Abstract

This disclosure describes a method for crimping a polymeric stent onto a catheter for percutaneous transluminal coronary angioplasty or other intraluminal interventions. The method comprises crimping the stent onto a catheter when the polymer is at a target temperature other than ambient temperature. The polymer can optionally comprise drug(s).

Claims

1. A method of making a medical device comprising a piece wherein the piece comprises a polymer or polymer combination and optionally drug(s), wherein the method comprises:

adjusting the temperature of the piece to a target temperature followed by a crimping step;

adjusting the temperature of the piece to a target temperature during a crimping step;

adjusting the temperature of the piece to a target temperature and maintaining the temperature of the piece within plus or minus 5°

C. of the target temperature during a crimping step;

adjusting the temperature of the piece to a target temperature followed by crimping such that the temperature of the piece remains within plus or minus 10°

C. of the target temperature during a crimping step;

or

adjusting the temperature of the piece to a temperature other than ambient towards a target temperature and continuing to adjust the temperature of the piece towards the target temperature during a crimping step.

2. The method of claim 1 wherein the crimping step comprises the steps of closing a crimper, adjusting the temperature of the piece to a second temperature, and opening the crimper wherein the second temperature is greater than or less than target temperature.

3. The method of claim 2 wherein the second temperature is an annealing temperature.

4. The method of claim 1 wherein the device further comprises a catheter and wherein the crimping step attaches the piece to the catheter.

5. The method of claim 1 wherein the polymer or polymer combination comprises a polymer with Tg below ambient temperature or comprises a polymer with Tg above ambient temperature.

6. The method of claim 1 wherein the polymer or polymer combination comprises a polymer that is one of or any combination of poly(ester amides);

ABS resins;

acrylic polymers and acrylic copolymers;

acrylonitrile-styrene copolymers;

alkyd resins;

cellulose ethers;

celluloses;

copoly(ether-esters);

copolymers of polycarboxylic acids and poly-hydroxycarboxylic acids;

copolymers of vinyl monomers with each other and olefins;

cyanoacrylates;

epoxy resins;

ethylene vinyl alcohol copolymer;

ethylene-α

-olefin copolymers;

ethylene-methyl methacrylate copolymers;

ethylene-vinyl acetate copolymers;

poly(amino acids);

poly(anhydrides);

poly(imino carbonates);

poly(iminocarbonate);

poly(orthoesters);

poly(tyrosine arylates);

poly(tyrosine derive carbonates);

polyacrylates;

polyacrylic acid;

polyacrylic acids;

polyacrylonitrile;

polyalkylene oxalates;

polyamides;

polyamino acids;

polyanhydride;

polyanhydrides;

polycarbonates;

polycarboxylic acids;

polycyanoacrylates;

polyesters;

polyethers;

poly-hydroxycarboxylic acids;

polyimides;

polyisobutylene and ethylene-α

-olefin copolymers;

polyketones;

polymethacrylates;

polyolefins;

polyorthoester;

polyorthoesters;

polyoxymethylenes;

polyphosphazenes;

polyphosphoester;

polyphosphoester urethane;

polyphosphoesters;

polyphosphoesters-urethane;

polyurethane;

polyurethanes;

poly(ether-urethanes), poly(ester-urethanes), poly(silicone-urethanes), polyvinyl alcohol;

polyvinyl aromatics;

polyvinyl esters;

polyvinyl ethers;

polyvinyl ketones;

poly(vinylidene fluoride), poly(vinylidene chloride), poly(vinylidene fluoride-co-hexafluoropropene), poly(vinylidene fluoride-co-chlorotrifluoroethylene), poly(vinyl fluoride), poly(vinyl chloride), polyvinylidene halides;

silicones;

starches;

vinyl copolymers vinyl-olefin copolymers;

vinyl halide polymers and copolymers; and

vinyl halide polymers vinyl halide polymers copolymers.

7. The method of claim 1 wherein the polymer or polymer combination comprises a polymer that is one of or any combination of starch, sodium alginate, rayon-triacetate, rayon, polyvinylidene fluoride, polyvinylidene chloride, polyvinyl pyrrolidone, polyvinyl methyl ether, polyvinyl chloride, polyvinyl acetate, polystyrene, polyisocyanate, polyisobutylene, polyethylene glycol, polydioxanone, polycaprolactone, polycaprolactam, polyacrylonitrile, poly(trimethylene carbonate), poly(L-lactic acid), poly(lactide-co-glycolide), poly(hydroxyvalerate), poly(hydroxybutyrate-co-valerate), poly(hydroxybutyrate-co-hydroxyvalerate), poly(hydroxybutyrate), poly(glycolide), poly(glycolic acid), poly(D,L-lactide-co-L-lactide), poly(D,L-lactide-co-glycolide), poly(D,L-lactide), poly(4-hydroxybutyrate), poly(3-hydroxybutyrate), poly(3-hydroxy valerate), Nylon 66, hyaluronic acid, fibrinogen, fibrin, elastin-collagen, collagen, cellulose propionate, cellulose nitrate, cellulose butyrate, cellulose acetate butyrate, cellulose acetate, cellulose, cellophane, carboxymethyl cellulose, or poly(2-hydroxyethyl methacrylate).

8. The method of claim 1 wherein the piece is selected from self-expandable stents, balloon-expandable stents, and stent-grafts.

9. The method of claim 1 wherein the piece comprises drug(s) selected from antiproliferative, antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, antioxidants, or their combinations.

10. The method of claim 1 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

11. The method of claim 10 wherein the target temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

12. The method of claim 10 wherein Tg range of the polymer or polymer combination excludes ambient temperature, excludes ambient temperature plus or minus 1°

C., or excludes ambient temperature plus or minus 5°

C.

13. The method of claim 10 wherein target temperature is chosen to yield a change in shore hardness wherein:

the change is plus 50% or plus 20%;

or

the change is minus 50% or minus 20%.

14. The method of claim 10 wherein the target temperature is

for polymers which have a shore hardness of 60D to 95D;

predominately exhibit delamination-based failure during crimping;

have a Tg above room temperature;

or have a Tg above ambient temperature;

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

15. The method of claim 10 wherein adjusting the temperature comprises disposing the piece in thermal contact with a heat source.

16. The method of claim 15 wherein adjusting the temperature comprises:

thermally contacting the coating or coated piece with a heat source;

directing a heated gas at the coating or coated piece;

placing the coating or coated piece near a heated surface for emitting thermal or infrared radiation to the coating or coated piece;

placing the coating or coated piece near a heated surface to enable convection to or from the coating or coated piece to the surface;

heating the jaws of the crimper; and

thermally contacting the coating or coated piece with the crimper jaws;

for crimper jaws that allow the passage of infrared radiation, bathing the stent on catheter with infrared radiation;

or

heating the stent on catheter in an incubator or oven to pre-equilibrate the stent on catheter to the desired temperature before crimping.

22. The method of claim 6 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

23. The method of claim 22 wherein the target temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

24. The method of claim 22 wherein Tg range of the polymer or polymer combination excludes ambient temperature, excludes ambient temperature plus or minus 1°

C., or excludes ambient temperature plus or minus 5°

C.

25. The method of claim 22 wherein target temperature is chosen to yield a change in shore hardness wherein:

the change is plus 50% or plus 20%;

or

the change is minus 50% or minus 20%.

26. The method of claim 22 wherein the target temperature is

for polymers which have a shore hardness of 60D to 95D;

predominately exhibit delamination-based failure during crimping;

have a Tg above room temperature;

or have a Tg above ambient temperature;

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

27. The method of claim 22 wherein adjusting the temperature comprises disposing the piece in thermal contact with a heat source.

28. The method of claim 27 wherein adjusting the temperature comprises:

thermally contacting the piece with a heat source;

directing a heated gas at the polymeric material or piece;

placing the polymeric material or piece near a heated surface for emitting thermal or infrared radiation to the polymeric material or piece;

placing the polymeric material or piece near a heated surface to enable convection to polymeric material or piece to the surface;

heating the jaws of the crimper; and

thermally contacting the polymeric material or piece with the crimper jaws;

for crimper jaws that allow the passage of infrared radiation, bathing the stent on catheter with infrared radiation;

or

heating the stent on catheter in an incubator or oven to pre-equilibrate the stent on catheter to the desired temperature before crimping.

33. The method of claim 9 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

34. The method of claim 33 wherein the target temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

35. The method of claim 33 wherein Tg range of the polymer or polymer combination excludes ambient temperature, excludes ambient temperature plus or minus 1°

C., or excludes ambient temperature plus or minus 5°

C.

36. The method of claim 33 wherein target temperature is chosen to yield a change in shore hardness wherein:

the change is plus 50% or plus 20%;

or

the change is minus 50% or minus 20%.

37. The method of claim 33 wherein the target temperature is

for polymers which have a shore hardness of 60D to 95D;

predominately exhibit delamination-based failure during crimping;

have a Tg above room temperature;

or have a Tg above ambient temperature;

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

38. The method of claim 33 wherein adjusting the temperature comprises disposing the piece in thermal contact with a heat source.

39. The method of claim 38 wherein adjusting the temperature comprises:

thermally contacting the polymeric material or piece with a heat source;

directing a heated gas at the polymeric material or piece;

placing the polymeric material or piece near a heated surface for emitting thermal or infrared radiation to the polymeric material or piece;

placing the polymeric material or piece near a heated surface to enable convection to or from the polymeric material or piece to the surface;

heating the jaws of the crimper; and

thermally contacting the polymeric material or piece with the crimper jaws;

for crimper jaws that allow the passage of infrared radiation, bathing the stent on catheter with infrared radiation;

or

heating the stent on catheter in an incubator or oven to pre-equilibrate the stent on catheter to the desired temperature before crimping.

57. The method of claim 2 wherein the second temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

58. The method of claim 57 wherein the second temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

60. The method of claim 57 wherein Tg range of the polymer or polymer combination excludes ambient temperature, excludes ambient temperature plus or minus 1°

C., or excludes ambient temperature plus or minus 5°

C.

61. The method of claim 2 wherein the annealing temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

62. The method of claim 61 wherein the annealing temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

63. The method of claim 61 wherein Tg range of the polymer or polymer combination excludes ambient temperature, excludes ambient temperature plus or minus 1°

C., or excludes ambient temperature plus or minus 5°

C.

17. A method of crimping a stent onto a delivery catheter or a balloon of the delivery catheter comprising:

positioning the stent on the catheter or the balloon; and

crimping the stent on the catheter or a balloon wherein crimping is done at a target temperature,

wherein the target temperature is other than ambient temperature.

18. The method of claim 17 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg;

between −

40°

C. and upper Tg;

between −

40°

C. and lower Tg;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

19. The method of claim 17 wherein for polymers that have a Tg above room temperature the target temperature is:

20. The method of claim 17 wherein the target temperature is:

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

21. The method of claim 17 wherein Tg range of the polymer or polymer combination excludes ambient temperature plus or minus 5°

C.

29. A method of crimping a stent onto a delivery catheter or a balloon of the delivery catheter comprising:

positioning the stent on the catheter or the balloon; and

crimping the stent on the catheter or a balloon wherein crimping is done at a target temperature,

wherein the target temperature is other than ambient temperature.

30. The method of claim 29 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg;

between −

40°

C. and upper Tg;

between −

40°

C. and lower Tg;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

31. The method of claim 29 wherein the target temperature is:

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg

between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

32. The method of claim 29 wherein Tg range of the polymer or polymer combination excludes ambient temperature plus or minus 5°

C.

40. A method of crimping a stent onto a delivery catheter or a balloon of the delivery catheter comprising:

positioning the stent on the catheter or the balloon; and

crimping the stent on the catheter or a balloon wherein crimping is done at a target temperature,

wherein the target temperature is other than ambient temperature.

41. The method of claim 40 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg;

between −

40°

C. and upper Tg;

between −

40°

C. and lower Tg;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

42. The method of claim 40 wherein for polymers that have a Tg above room temperature the target temperature is:

43. The method of claim 40 wherein the target temperature is:

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

at or above 60°

C.;

between ambient temperature and upper Tg;

between ambient temperature and lower Tg between 60°

C. and upper Tg;

between 60°

C. and lower Tg;

or

between 60°

C. and ambient temperature.

44. The method of claim 40 wherein Tg range of the polymer or polymer combination excludes ambient temperature plus or minus 5°

C.

45. A method of making a medical device, having an implantable portion, comprising:

forming the implantable portion from a polymeric material; and

adjusting the temperature of the implantable portion to a target temperature followed by a step of attaching the implantable portion to a delivery device;

adjusting the temperature of the implantable portion to a target temperature during a step of attaching the implantable portion to a delivery device;

adjusting the temperature of the implantable portion to a target temperature and maintaining the temperature of the implantable portion within plus or minus 5°

C. of the target temperature during a step of attaching the implantable portion to a delivery device;

adjusting the temperature of the implantable portion to a target temperature followed by attaching such that the temperature of the implantable portion remains within plus or minus 10°

C. of the target temperature during a step of attaching the implantable portion to a delivery device;

or

adjusting the temperature of the implantable portion to a temperature other than ambient towards a target temperature and continuing to adjust the temperature of the implantable portion towards the target temperature during a step of attaching the implantable portion to a delivery device.

46. The method of claim 45 wherein the delivery device is a catheter.

47. The method of claim 45 wherein the polymer or polymer combination comprises a polymer with Tg above ambient temperature.

48. The method of claim 45 wherein the polymer or polymer combination comprises a polymer that is one of or any combination of poly(ester amides);

ABS resins;

acrylic polymers and acrylic copolymers;

acrylonitrile-styrene copolymers;

alkyd resins;

cellulose ethers;

celluloses;

copoly(ether-esters);

copolymers of polycarboxylic acids and poly-hydroxycarboxylic acids;

copolymers of vinyl monomers with each other and olefins;

cyanoacrylates;

epoxy resins;

ethylene vinyl alcohol copolymer;

ethylene-α

-olefin copolymers;

ethylene-methyl methacrylate copolymers;

ethylene-vinyl acetate copolymers;

poly(amino acids);

poly(anhydrides);

poly(imino carbonates);

poly(iminocarbonate);

poly(orthoesters);

poly(tyrosine arylates);

poly(tyrosine derive carbonates);

polyacrylates;

polyacrylic acid;

polyacrylic acids;

polyacrylonitrile;

polyalkylene oxalates;

polyamides;

polyamino acids;

polyanhydride;

polyanhydrides;

polycarbonates;

polycarboxylic acids;

polycyanoacrylates;

polyesters;

polyethers;

poly-hydroxycarboxylic acids;

polyimides;

polyisobutylene and ethylene-α

-olefin copolymers;

polyketones;

polymethacrylates;

polyolefins;

polyorthoester;

polyorthoesters;

polyoxymethylenes;

polyphosphazenes;

polyphosphoester;

polyphosphoester urethane;

polyphosphoesters;

polyphosphoesters-urethane;

polyurethane;

polyurethanes;

poly(ether-urethanes), poly(ester-urethanes), poly(silicone-urethanes), polyvinyl alcohol;

polyvinyl aromatics;

polyvinyl esters;

polyvinyl ethers;

polyvinyl ketones;

poly(vinylidene fluoride), poly(vinylidene chloride), poly(vinylidene fluoride-co-hexafluoropropene), poly(vinylidene fluoride-co-chlorotrifluoroethylene), poly(vinyl fluoride), poly(vinyl chloride), polyvinylidene halides;

silicones;

starches;

vinyl copolymers vinyl-olefin copolymers;

vinyl halide polymers and copolymers; and

vinyl halide polymers vinyl halide polymers copolymers.

49. The method of claim 45 wherein the polymer or polymer combination comprises a polymer that is one of or any combination of starch, sodium alginate, rayon-triacetate, rayon, polyvinylidene fluoride, polyvinylidene chloride, polyvinyl pyrrolidone, polyvinyl methyl ether, polyvinyl chloride, polyvinyl acetate, polystyrene, polyisocyanate, polyisobutylene, polyethylene glycol, polydioxanone, polycaprolactone, polycaprolactam, polyacrylonitrile, poly(trimethylene carbonate), poly(L-lactic acid), poly(lactide-co-glycolide), poly(hydroxyvalerate), poly(hydroxybutyrate-co-valerate), poly(hydroxybutyrate-co-hydroxyvalerate), poly(hydroxybutyrate), poly(glycolide), poly(glycolic acid), poly(D,L-lactide-co-L-lactide), poly(D,L-lactide-co-glycolide), poly(D,L-lactide), poly(4-hydroxybutyrate), poly(3-hydroxybutyrate), poly(3-hydroxy valerate), Nylon 66, hyaluronic acid, fibrinogen, fibrin, elastin-collagen, collagen, cellulose propionate, cellulose nitrate, cellulose butyrate, cellulose acetate butyrate, cellulose acetate, cellulose, cellophane, carboxymethyl cellulose, or poly(2-hydroxyethyl methacrylate).

50. The method of claim 45 wherein the piece is selected from self-expandable stents, balloon-expandable stents, and stent-grafts

51. The method of claim 45 wherein the piece comprises drug(s) selected from antiproliferative, antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, antioxidants, or their combinations.

52. The method of claim 45 wherein the target temperature is

within or above the range defined by definition 1, definition 2, definition 3, definition 4, definition 5, definition 6, or definition 7 of the Tg range of the polymer or polymer combination;

above ambient temperature;

above room temperature;

between ambient temperature and upper Tg of the Tg range;

between ambient temperature and lower Tg of the Tg range;

between −

40°

C. and upper Tg of the Tg range;

between −

40°

C. and lower Tg of the Tg range;

between −

40°

C. and ambient temperature;

at or above 60°

C.;

between 60°

C. and upper Tg of the Tg range;

between 60°

C. and lower Tg of the Tg range;

or

between 60°

C. and ambient temperature.

53. The method of claim 45 wherein the target temperature is limited to a temperature below the temperature at which therapeutic agents substantially decompose.

54. The method of claim 45 wherein the polymer portion of the implantable stents have a lower areal density of cracks.

55. The method of claim 45 wherein the polymer portion of the implantable stents is e-beam sterilized.

56. The method of claim 56 wherein the polymer portion of the implantable stents have a lower areal density of cracks.