Method for applying drug coating to a medical device in surgeon room
View Patent ↗Medical devices, and in particular implantable medical devices such as stents and stent delivery systems including catheters, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism or to treat a particular condition. A dip coating process is utilized to minimize waste and to customize coating thickness and drug loading directly at the clinical site just prior to therapeutic use on a patient. An aqueous latex polymeric emulsion is utilized to coat any medical device to a desired thickness by allowing for successive dipping and drying cycles at the clinical site. In addition, aqueous latex polymeric emulsions pose less of a chance of the bridging phenomenon associated with organic solvent based polymers.
1. A method for coating a medical device at a clinical site just prior to use of the medical device on the patient, the method comprising the steps of
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) dipping a medical device in the aqueous latex polymeric emulsion at the clinical site;
(c) drying the aqueous latex polymeric emulsion on the medical device to form a coating thereon;
(d) repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness; and
(e) using the coated medical device in a therapeutic procedure on a patient at the clinical site immediately after performing step (d).
2. The method for coating a medical device according to claim 1 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
3. The method for coating a medical device according to claim 2 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
4. The method for coating a medical device according to claim 1 , wherein the step of drying the aqueous latex polymeric emulsion on the medical device to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the medical devices.
5. The method for coating a medical device according to claim 1 , wherein the step of repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
6. A method for coating a medical device at a clinical site just prior to use of the medical device on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) adding at least one drug, agent and/or compound, in therapeutic dosages, to the aqueous latex polymeric emulsion for the treatment of a predetermined condition;
(c) dipping the medical device in the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound at the clinical site;
(d) drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the medical device to form a coating thereon;
(e) repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound coating reaches a predetermined thickness; and
(f) using the coated medical device in a therapeutic procedure on a patient at the clinical site immediately after performing step (e).
7. The method for coating a medical device according to claim 6 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
8. The method for coating a medical device according to claim 7 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
9. The method for coating a medical device according to claim 6 , wherein the step of adding at least one drug, agent and/or compound comprises adding an antiproliferative.
10. The method for coating a medical device according to claim 9 , wherein the step of adding at least one drug, agent and/or compound comprises adding rapamycin.
11. The method for coating a medical device according to claim 6 , wherein the step of drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the medical device to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the medical devices.
12. The method for coating a medical device according to claim 6 , wherein the step of repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
13. A method for coating a stent at a clinical site just prior to use of the stent on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) dipping the stent in the aqueous latex polymeric emulsion at the clinical site;
(c) drying the aqueous latex polymeric emulsion on the stent to form a coating thereon;
(d) repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness; and
(e) using the coated stent in a therapeutic procedure on a patient at the clinical site immediately after performing step (d).
14. The method for coating a stent according to claim 13 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
15. The method for coating a stent according to claim 14 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
16. The method for coating a stent according to claim 13 , wherein the step of drying the aqueous latex polymeric emulsion on the stent to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the stent.
17. The method for coating a stent according to claim 13 , wherein the step of repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
18. A method for coating a stent at a clinical site just prior to use of the stent on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) adding at least one drug, agent and/or compound, in therapeutic dosages, to the aqueous latex polymeric emulsion for the treatment of a predetermined condition;
(c) dipping the stent in the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound at the clinical site;
(d) drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the stent to form a coating thereon;
(e) repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound coating reaches a predetermined thickness; and
(f) using the coated stent in a therapeutic procedure on a patient at the clinical site immediately after performing step (e).
19. The method for coating a stent according to claim 18 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
20. The method for coating a stent according to claim 19 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
21. The method for coating a stent according to claim 18 , wherein the step of adding at least one drug, agent and/or compound comprises adding an antiproliferative.
22. The method for coating a stent according to claim 21 , wherein the step of adding at least one drug, agent and/or compound comprises adding rapamycin.
23. The method for coating a stent according to claim 18 , wherein the step of drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the stent to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the stent.
24. The method for coating a stent according to claim 18 , wherein the step of repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
25. A method for coating a stent delivery system at a clinical site just prior to use of the stent delivery system on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) dipping the stent delivery system in the aqueous latex polymeric emulsion at the clinical site;
(c) drying the aqueous latex polymeric emulsion on the stent delivery system to form a coating thereon;
(d) repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness; and
(e) using the coated stent delivery system in a therapeutic procedure on a patient at the clinical site immediately after performing step (d).
26. The method for coating a stent delivery system according to claim 25 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
27. The method for coating a stent delivery system according to claim 26 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
28. The method for coating a stent delivery system according to claim 25 , wherein the step of drying the aqueous latex polymeric emulsion on the stent delivery system to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the stent delivery system.
29. The method for coating a stent delivery system according to claim 25 , wherein the step of repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
30. A method for coating a stent delivery system at a clinical site just prior to use of the stent delivery system on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) adding at least one drug, agent and/or compound, in therapeutic dosages, to the aqueous latex polymeric emulsion for the treatment of a predetermined condition;
(c) dipping the stent delivery system in the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound at the clinical site;
(d) drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the stent delivery system to form a coating thereon;
(e) repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound coating reaches a predetermined thickness; and
(f) using the coated stent delivery system in a therapeutic procedure on a patient at the clinical site immediately after performing step (e).
31. The method for coating a stent delivery system according to claim 30 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
32. The method for coating a stent delivery system according to claim 31 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
33. The method for coating a stent delivery system according to claim 30 , wherein the step of adding at least one drug, agent and/or compound comprises adding an antiproliferative.
34. The method for coating a stent delivery system according to claim 33 , wherein the step of adding at least one drug, agent and/or compound comprises adding rapamycin.
35. The method for coating a stent delivery system according to claim 30 , wherein the step of drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the stent delivery system to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the stent delivery system.
36. The method for coating a stent delivery system according to claim 30 , wherein the step of repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
37. A method for coating a catheter at a clinical site just prior to use of the catheter on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) dipping the catheter in the aqueous latex polymeric emulsion at the clinical site;
(c) drying the aqueous latex polymeric emulsion on the catheter to form a coating thereon;
(d) repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness; and
(e) using the coated catheter in a therapeutic procedure on a patient at the clinical site immediately after performing step (d).
38. The method for coating a catheter according to claim 37 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
39. The method for coating a catheter according to claim 38 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
40. The method for coating a catheter according to claim 37 , wherein the step of drying the aqueous latex polymeric emulsion on the catheter to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the catheter.
41. The method for coating a catheter according to claim 37 , wherein the step of repeating steps (b) and (c) until the aqueous latex polymeric emulsion coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.
42. A method for coating a catheter at a clinical site just prior to use of the catheter on a patient, the method comprising the steps of:
(a) preparing an aqueous latex polymeric emulsion at the clinical site;
(b) adding at least one drug, agent and/or compound, in therapeutic dosages, to the aqueous latex polymeric emulsion for the treatment of a predetermined condition;
(c) dipping the catheter in the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound at the clinical site;
(d) drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the catheter to form a coating thereon;
(e) repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound coating reaches a predetermined thickness; and
(f) using the coated catheter in a therapeutic procedure on a patient at the clinical site immediately after performing step (e).
43. The method for coating a catheter according to claim 42 , wherein the step of preparing an aqueous latex polymeric emulsion comprises mixing vinylidenefluoride and hexafluoropropylene in water.
44. The method for coating a catheter according to claim 43 , wherein the step of mixing vinylidenefluoride and hexafluoropropylene in water comprises adding vinylidenefluoride and hexafluoropropylene to the water in an approximately twenty-five to seventy-five ratio by weight.
45. The method for coating a catheter according to claim 42 , wherein the step of adding at least one drug, agent and/or compound comprises adding an antiproliferative.
46. The method for coating a catheter according to claim 45 , wherein the step of adding at least one drug, agent and/or compound comprises adding rapamycin.
47. The method for coating a catheter according to claim 42 , wherein the step of drying the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, on the catheter to form a coating thereon comprises allowing the water to evaporate from the aqueous latex polymeric emulsion thereby depositing a film on the surface of the catheter.
48. The method for coating a catheter according to claim 42 , wherein the step of repeating steps (c) and (d) until the aqueous latex polymeric emulsion, including the at least one drug, agent and/or compound, coating reaches a predetermined thickness comprises creating a coating in the range from about four to about fifteen microns.