Cryo Activated Drug Delivery and Cutting Balloons

• US 20110160645A1
• Filed: 11/04/2010
• Published: 06/30/2011
• Est. Priority Date: 12/31/2009
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Sutermeister, Derek, Anderson, James
• Application Number:
  US12/939,864
• Publication Number:
  US 20110160645A1
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Physical property changes in materials between body temperature and a cryotreatment temperature are used to benefit auxiliary functional structures on a cryotherapy device. The auxiliary functional structures may be drug delivery coatings, cutting balloon blades, balloon stiffeners or force concentrators.

Claims

1. A medical device comprising

a balloon and

a cryogen introduction system for introducing a cryogen into the balloon,

wherein the balloon comprises an auxiliary functional structure formed of a material composition that is in a soft and flexible state at body temperature and that is in a relatively harder, more frangible, and/or less adherent state when cooled at a cooling rate obtainable with said cryogen introduction system to a cryotreatment temperature at which the balloon remains functionally operable.

2. A medical device as in claim 1 wherein said cryotreatment temperature is in the range of from about −

30°

C. to about 10°

C.

3. A medical device as in claim 1 wherein

the balloon is expandable at a site within the body of a subject to be treated,

said auxiliary functional structure comprises a coating on an outer surface thereof comprising a drug, and

the coating is adapted to be adherent to the balloon surface at body temperature but to at least partially release therefrom when the balloon is cooled and expanded.

4. A medical device as in claim 3 wherein said drug comprises at least one member from the group consisting of anti-restenosis agents, antiproliferative agents, antibiotic agents, antimitotic agents, antiplatelet agents, alkylating agents, platinum coordination complexes, hormones, anticoagulants, fibrinolytic agents, antimigratory agents, antisecretory agents, anti-inflammatory agents, indole acetic acids, indene acetic acids, immunosuppressive agents, angiogenic agents, angiotensen receptor blockers, nitric oxide donors, anti-sense oligonucleotides, cell cycle inhibitors, mTOR inhibitors, growth factor receptor signal inhibitors, transduction kinase inhibitors, retenoids, cyclin/CDK inhibitors, HMG co-enzyme reductase inhibitors, protease inhibitors, viral gene vectors, macrophages, monoclonal antibodies, x-ray contrast agents, MRI contrast agents, ultrasound contrast agents, chromogenic dyes, fluorescent dyes, and luminescent dyes.

5. A medical device as in claim 3 wherein said drug comprises at least one member of the group consisting of paclitaxel, rapamycin, everolimus, zotarolimus, biolimus A9, dexamethasone and tranilast.

6. A medical device as in claim 5 wherein said drug comprises paclitaxel dihydrate in particulate form.

7. A medical device as in claim 6 wherein at least a portion of the paclitaxel dihydrate in particulate form has a particle size of less than 1 μ

m.

8. A medical device as in claim 3 where said drug coating further comprises a polymer.

9. A medical device as in claim 8 wherein said polymer is biodegradable.

10. A medical device as in claim 8 wherein said polymer is a member of the group consisting of polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amido groups, poly(anhydrides), polyphosphazenes, poly-α

-hydroxy acids, trimethylene carbonate, poly-β

-hydroxy acids, polyorganophosphazines, polyesteramides, polyethylene oxide, polyester-ethers, polyphosphoester, polyphosphoester urethane, cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyvinylpyrolidone, polyvinyl alcohol, poly-N-(2-hydroxypropyl)-methacrylamide, polyglycols, aliphatic polyesters, poly(ester-amides), polyanhydrides, polysaccharides, proteins and mixtures thereof.

11. A medical device as in claim 8 further comprising a biodegradable plasticizer.

12. A medical device as in claim 11 wherein said plasticizer is selected from the group consisting of tributyl citrate, triethyl citrate, acetyltributyl citrate, and acetyltriethyl citrate;

polyols, starches;

vegetable oils;

glucose or sucrose ethers and esters;

polyethylene glycol ethers and esters;

low toxicity phthalates;

alkyl phosphate esters;

dialkylether diesters;

tricarboxylic esters;

epoxidized oils;

epoxidized esters;

polyesters;

polyglycol diesters;

aliphatic diesters;

alkylether monoesters;

dicarboxylic esters;

lecithin; and

/or combinations thereof.

13. A medical device as in claim 1 wherein said balloon includes at least and inner balloon member and an outer balloon member.

14. A medical device as in claim 1 wherein said auxiliary functional structure comprises a cutting blade, force concentrator or a balloon stiffener mounted on the balloon.

15. A medical device as in claim 14 wherein said cutting blade, a force concentrator, or a balloon stiffener is formed of a polymer composition that is in a soft rubbery state at room temperature and that stiffens sufficiently to function effectively when cooled to said cryotreatment temperature.

16. A medical device as in claim 1 wherein the auxiliary functional structure is formed of a material composition that undergoes a glass transition between body temperature and said cryotreatment temperature.

17. A medical device as in claim 1 wherein the auxiliary functional structure is formed of a material composition that undergoes an increase in flexural modulus of about 15% or more between body temperature and the cryotreatment temperature.

20. A method of treating a subject body comprising

manipulating a device as in claim 1 to a treatment site within the subject body while the device is at body temperature,

cooling the device to a said cryotreatment temperature,

operating said auxiliary functional structure at the cryotreatment temperature,

returning the device to body temperature, and

removing the device from the subject body.

18. A medical device comprising

a balloon and

a cryogen introduction system for introducing a cryogen into the balloon,

wherein the balloon comprises an auxiliary functional structure selected from the group consisting of a cutting blade, a force concentrator, or a stiffening member, said auxiliary functional structure being formed of a two-way shape memory material having a phase transition between two memory states that occurs at a temperature between body temperature and a cryotreatment temperature.

19. A medical device as in claim 18 wherein said two memory states comprises

a functional configuration when said balloon is at said cryotreatment temperature of said cutting blade, force concentrator, or stiffening member, respectively, for cutting a lesion, concentrating applied balloon force or stiffening the balloon, and

a body temperature configuration in which when the balloon is deflated said cutting blade, force concentrator, or stiffening member wraps around the deflated balloon.