Thermal balloon angioplasty with thermoplastic stent

• US 5,292,321 A
• Filed: 03/01/1993
• Issued: 03/08/1994
• Est. Priority Date: 06/08/1990
• Status: Expired due to Term

• Current Assignee: Benjamin I. Lee
• Original Assignee: Benjamin I. Lee
• Inventors: Lee, Benjamin I.
• Primary Examiner(s): ASCHENBRENNER, PETER
• Application Number:
  US08/025,415
• Time in Patent Office: 372 Days
• Field of Search: 600/192, 600/194, 600/7, 600/27-31, 600/41, 600/42, 600/198, 600/108, 604/96
• US Class Current: 606/28
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method is provided for remodeling a body lumen, such as a coronary artery, having a stenosis using a thermoplastic stent including the steps of increasing the temperature of the thermoplastic stent, body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the stent, stenosis and body lumen region from a relatively solid state into a softer and more moldable state and thereafter expanding the stenosis and the body lumen region while in the softer and more moldable state to thus reduce the tendency to fracture during expansion while enabling the stent to contact an inner surface of a wall of the body lumen, and reducing the temperature of the thermoplastic stent, stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state thereof so that the thermoplastic tent molds against the surface of the inner surface of the wall of the body lumen to maintain the stenosis and body lumen region in the expanded condition. An improved heat applying balloon catheter is provided including passages for displacing the heated balloon inflating liquid with a cooling liquid to carry out the method.

Claims

1. A method for delivering a stent within a coronary artery having a stenosis comprising the steps of:

positioning a balloon of a catheter within the stenosis of the artery, said balloon having a thermoplastic stent disposed thereon in an unexpanded condition to be expanded by the inflation of said balloon within the stenosis,

increasing the temperature of the thermoplastic stent, stenosis and artery surrounding the balloon prior to the inflation of the balloon to an inflation extent sufficient to cause outward expansion for a clinically appropriate time period and to a temperature level sufficient to cause a change in the thermoplastic stent, stenosis and surrounding artery from a relatively solid state into a softer and more moldable state and thereafter,

increasing the inflation of the balloon so that outward expansion of the thermoplastic stent occurs within the stenosis and artery in said softer and more moldable state to thus reduce the tendency of the stenosis and artery to fracture during expansion,

reducing the temperature of the thermoplastic stent, stenosis and surrounding artery while maintaining the expansion by balloon inflation for a clinically appropriate time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent, stenosis and surrounding artery; and

then deflating the balloon and thereafter withdrawing the catheter.

2. A method as defined in claim 1 wherein the inflation of the balloon is accomplished by introducing a preheated liquid within the balloon at a preheated temperature above room temperature.

3. A method as defined in claim 2 wherein during the increase in temperature of the thermoplastic stent, stenosis and artery, the balloon is expanded so that the thermoplastic stent contacts the stenosis and artery surrounding the balloon by the preheated liquid introduced within the balloon and the increase in temperature of the thermoplastic stent, stenosis and artery is accomplished through conduction from the preheated liquid within the balloon and by electrically heating a resistance element in contact with the preheated liquid within the balloon inflating by completing a circuit through the resistance element and a source of alternating electrical current.

4. A method as defined in claim 3 wherein the completion of the circuit is accomplished after the beginning of the introduction of the preheated liquid within the balloon and before the balloon is expanded into contact with the stenosis and artery.

5. A method as defined in claim 3 wherein the reduction in temperature is accomplished by replacing the preheated liquid used to inflate the balloon with cooling liquid at a temperature below room temperature.

6. A method as defined in claim 5 wherein the temperature of the cooling liquid is within the range of 0°

to 38°

C.

7. A method as defined in claim 6 wherein the increase in the inflation pressure of the balloon is to maximum inflation pressure and is accomplished in conjunction with the replacing of the heating and inflating liquid with a cooling liquid.

8. The method as defined in claim 7 wherein the cooling is provided for a period sufficient to reduce the thermoplastic stent and tissue temperature to room temperature.

9. The method as defined in claim 8 wherein cooling to room temperature is accomplished in approximately 5 seconds.

10. A method for remodeling a body lumen having a stenosis, to expand the stenosis comprising the steps of:

positioning a thermoplastic stent within the stenosis of the lumen,

increasing the temperature of the thermoplastic stent, body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the thermoplastic stent, stenosis and body lumen region from a relatively solid state into a softer and more moldable state and thereafter expanding the thermoplastic stent, stenosis and the body lumen region while in said softer and more moldable state to thus reduce the tendency to fracture during expansion while enabling the thermoplastic stent to contact an inner surface of a wall of the body lumen at the stenosis, and

reducing the temperature of the thermoplastic stent, stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent, stenosis and body lumen region so that the thermoplastic stent molds against the inner surface of the wall of the body lumen to maintain the stenosis and body lumen region in the expanded condition.

11. A method as defined in claim 10 wherein said increased temperature level is within the range of 45°

to 90°

C.

12. A method as defined in claim 11 wherein said temperature level is approximately 60°

to 70°

C.

13. A method as defined in claim 12 wherein the reduced temperature level is approximately 25°

C.

14. An angioplasty apparatus for remodeling a body lumen having a stenosis to expand the stenosis comprising:

a catheter comprising an elongated body of flexible material having a distal end portion,

an expandable balloon having an interior surrounding said catheter at the distal end thereof,

a thermoplastic stent disposed on said balloon in an unexpanded state to be expanded by inflation of the balloon within the stenosis,

said catheter body having an inlet passage extending longitudinally therethrough from an inlet position therein to an outlet position at said distal end portion and an outlet passage extending longitudinally therethrough from an inlet portion at said distal end portions to an outlet position,

said inlet passage having an outlet opening at said outlet position communicating with the interior of said balloon through which liquid under pressure in said inlet passage can enter the interior of said balloon, said outlet passage having an inlet opening at said inlet position communicating with the interior of said balloon through which liquid under pressure within said balloon can pass from the balloon into the outlet passage,

heating means at the distal end portion of said catheter operable when connected with a source of electrical energy to heat liquid within the interior of said balloon,

wire means extending within the flexible material of said catheter for selectively connecting a remote source of electrical energy with said heating means,

and means operatively connected with the catheter at the inlet and outlet positions of said inlet and outlet passages for (1) introducing a balloon inflating and heating liquid within said inlet passage with an initial temperature which in combination with heat generated by said heating means is sufficient to heat the balloon so that the thermoplastic stent changes from a relatively solid state to a softer and more moldable state and with an initial pressure to establish a liquid pressure within said balloon sufficient to and inflate the same so that the moldable thermoplastic stent contacts an area of stenosis within a body lumen region within which the distal end portion of said catheter is engaged while said wire means connects the electrical energy source to said heating means to operate the same to heat the liquid under pressure within the balloon to a predetermined temperature sufficient to maintain the thermoplastic stent in its moldable state and conduct sufficient heat to the body lumen region to change the tissue in the arterial region and stenosis from a relatively solid state into a softer and more moldable state so that while therein an increase in the liquid pressure within the balloon increases the inflation of the balloon and expands the stent and thus the area of stenosis within the body lumen region within a first predetermined time (2) following the expiration of the first predetermined time displacing the balloon inflation and heating liquid within said inlet passage and the interior of said balloon outward through said outlet passage with a cooling liquid while maintaining an inflating pressure within the interior of said balloon for a second predetermined time sufficient to change the thermoplastic stent, tissue in the body lumen region and stenosis into a relatively solid state, and (3) following the expiration of the second predetermined time relieving the pressure of the liquid within the interior of the balloon sufficient to deflate the same for removal from the body lumen region leaving the thermoplastic stent within the body lumen to maintain the stenosis and body lumen in an expanded condition.

15. An angioplasty apparatus as defined in claim 14 wherein a distal portion of said catheter body is formed with a central opening for moving a guide wire therethrough.

16. An apparatus as claimed in claim 15 wherein said balloon includes an annular wall having one end fixed to the distal end of said catheter body and an opposite end fixed to the distal end portion of said catheter body inwardly of the distal end thereof.

17. An apparatus as claimed in claim 16, wherein said wire means includes a pair of wires fixed within the flexible material of the catheter body, said heating means including a braided sleeve of electrical resistance wire on the distal end portion of said catheter body intermediate the ends of the balloon, said sleeve having ends connected with said pair of wires.

18. An apparatus as claimed in claim 17 wherein the source of electrical energy is an alternating current.

19. An apparatus as claimed in claim 18, wherein said alternating current has a cycle within the radio frequency range.

20. An apparatus as claimed in claim 18 wherein said means connected with said inlet and outlet passages includes a syringe pump and a check valve.

21. An apparatus as claimed in claim 14, wherein said thermoplastic stent is bioabsorbable, biocompatible, biodegradable, non-thrombogenic and sterilizable.

22. An apparatus as claimed in claim 14, wherein said thermoplastic stent is formed from a material having a glass transition temperature in the range of 45°

C. to 90°

C.

23. An apparatus as claimed in claim 14, wherein the thermoplastic stent is tubular.

33. An apparatus as claimed in claim 14, wherein said thermoplastic stent is formed from material selected from the group consisting of polylactide, polyglycolide, polylactide co-glycolide, polydioxanone, polyethylene, polyiminocarbonate, polycaprolactone and polyester.

24. Apparatus for remodeling a body lumen having a stenosis to expand the stenosis comprising:

a catheter having a distal end,

a thermoplastic stent disposed on said distal end in an unexpanded condition,

means connected with said catheter for (1) increasing the temperature of the thermoplastic stent, body lumen and stenosis at the region of the stenosis for a time period and to a temperature level sufficient to cause a change in the thermoplastic stent, stenosis and body lumen region from a relatively solid state into a softer and more moldable state and (2) thereafter expanding the thermoplastic stent, stenosis and the body lumen region while in said softer and more moldable state to thus reduce the tendency of the stenosis and body lumen to fracture during expansion, and

means connected with said catheter for reducing the temperature of the thermoplastic stent, stenosis and body lumen region while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent, stenosis and body lumen.

25. A method for delivering a stent to a desired position within a body lumen comprising the steps of:

positioning a balloon of a catheter within the lumen at the desired position, said balloon having a thermoplastic stent disposed thereon in an unexpanded condition to be expanded by the inflation of said balloon within the lumen,

increasing the temperature of the thermoplastic stent prior to the inflation of the balloon to an inflation extent sufficient to cause outward expansion for a clinically appropriate time period and to a temperature level sufficient to cause a change in the thermoplastic stent from a relatively solid state into a softer and more moldable state and thereafter,

increasing the inflation of the balloon so that outward expansion of the thermoplastic stent occurs within the lumen until the stent is in full contact with an interior surface of the lumen, thus achieving a desired stent diameter,

reducing the temperature of the thermoplastic stent while maintaining the expansion by balloon inflation for a clinically appropriate time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent; and

then deflating the balloon and thereafter withdrawing the catheter.

26. Apparatus for delivering a stent to a desired position within a body lumen comprising:

a catheter having a distal end,

a thermoplastic stent disposed on said distal end of said catheter in an unexpanded condition,

means connected with said catheter for (1) increasing the temperature of the thermoplastic stent at the desired position within the body lumen for a time period and to a temperature level sufficient to cause a change in the thermoplastic stent from a relatively solid state into a softer and more moldable state and (2) thereafter expanding the thermoplastic stent, while in said softer and more moldable state, and

means connected with said catheter for reducing the temperature of the thermoplastic stent while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent.

27. An apparatus as claimed in claim 26, wherein said thermoplastic stent is bioabsorbable, biocompatible, biodegradable, non-thrombogenic and sterilizable.

28. An apparatus as claimed in claim 26, wherein said thermoplastic stent is formed from a material having a glass transition temperature in the range of 45°

C. to 90°

C.

29. An apparatus as claimed in claim 26, wherein said thermoplastic stent is a solid tubular member.

30. An apparatus as claimed in claim 26, wherein said thermoplastic stent is impregnated with an anti-coagulation agent.

31. An apparatus as claimed in claim 26, wherein said thermoplastic stent is impregnated with one of an anti-proliferative agent and gene transfecting agent.

34. An apparatus as claimed in claim 26, wherein said thermoplastic stent is formed from material selected from the group consisting of polylactide, polyglycolide, polylactide co-glycolide, polydioxanone, polyethylene, polyiminocarbonate, polycaprolactone and polyester.

32. A method for delivering a stent to a desired position within a body lumen comprising the steps of:

positioning a thermoplastic stent at the desired position within the lumen,

increasing the temperature of the thermoplastic stent for a time period and to a temperature level sufficient to cause a change in the thermoplastic stent from a relatively solid state into a softer and more moldable state and thereafter expanding the thermoplastic stent while in said softer and more moldable state, and

reducing the temperature of the thermoplastic stent while maintaining the expansion for a time period and to a temperature level sufficient to re-establish the relatively solid state of the thermoplastic stent.