In-vivo modification of the mechanical properties of surgical devices

• US 5,853,408 A
• Filed: 06/01/1995
• Issued: 12/29/1998
• Est. Priority Date: 08/20/1992
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Muni, Ketan P.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/457,325
• Time in Patent Office: 1,307 Days
• Field of Search: 606/27, 606/28, 606/192, 606/194, 604/94, 604/280-281
• US Class Current: 606/27
• CPC Class Codes: A61M 2025/0064 which become stiffer or softer when heated
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip

Abstract

The mechanical properties of various angioplastic surgical devices are altered in order to enhance their transportability through the vascular system by changing their operating temperature while situated within the body. Temperature increases are utilized to increase flexibility or cause devices to assume certain configurations while a temperature decrease serves to increase stiffness and rupture strength.

Claims

1. A medical device for insertion into and transport through a patient'"'"'s vascular system, comprising:

an elongate member including a shaft, said shaft having a selected region formed of material having mechanical properties subject to change upon variation of said material'"'"'s operating temperature; and

means for communicating a temperature controlled fluid to the selected region of said shaft for varying the selected region'"'"'s operating temperature without varying the operating temperature of an unselected region of the shaft of the elongate member, whereby the mechanical properties of the selected region of the shaft can be changed without changing the mechanical properties of the unselected region of the shaft of the elongate member.

2. The device of claim 1, wherein said control means includes heating means for increasing the operating temperature of the selected region of said elongate member.

3. The device of claim 1, wherein said elongate member further comprises a dilatation catheter having a balloon portion on a distal end of said shaft, said balloon portion becoming more flexible upon application of a heated fluid to raise the temperature of said balloon portion.

4. The device of claim 1, wherein said elongate member is formed from a polymeric material taken from the group of polymeric materials including linear low density polyethylene, high density polyethylene, polyethylene, polypropylene, polyethylene teraphthalate (PET), polyolefins, polyvinyl chloride, polyester, polyimide, polyamides, nylon, polyurethane, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyamide elastomer, and surlyn ionomer.

5. The device of claim 1, wherein said control means for controllably varying the selected region'"'"'s operating temperature includes controlling temperature in the range of 0°

C. to 70°

C.

6. A dilatation catheter system, comprising:

a shaft having a proximal end and a distal end formed of a material which becomes increasingly flexible as its operating temperature is increased; and

control means for communicating a temperature controlled fluid to the distal end of the shaft for increasing the temperature of said distal end without increasing the temperature of the proximal end of the shaft whereby the distal end can be made increasingly flexible by increasing the temperature of the distal end of the shaft, without increasing the flexibility of the proximal end of the shaft.

7. The dilatation catheter of claim 6, wherein said distal end further comprises a balloon portion having increasing flexibility as its temperature is increased by said heated fluid.

8. The dilatation catheter of claim 7, wherein said balloon portion increases in diameter in the range of 3% to 10%.

9. The dilatation catheter of claim 6, wherein said distal end of said catheter is formed from a polymeric material taken from the group of polymeric materials including linear low density polyethylene, high density polyethylene, polyethylene, polypropylene, polyethylene teraphthalate (PET), polyolefins, polyvinyl chloride, polyester, polyimide, polyamides, nylon, polyurethane, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyamide elastomer, and surlyn ionomer.

10. A balloon catheter system for insertion into and transport through a patient'"'"'s vascular system, comprising:

an elongate tubular member having a proximal portion and a distal portion;

an inflatable member carried by the distal portion of elongate tubular member, said inflatable member being formed of polymeric material which permits said inflatable member to assume an increasingly tightly folded configuration as its temperature is increased and increased rupture strength as its temperature is decreased; and

control means for introducing temperature controlled fluid into the distal portion of said elongate tubular member and said inflatable member for varying the temperature of said distal portion of said elongate tubular member and said inflatable member without varying the temperature of said proximal portion of the elongate tubular member.

11. A method for varying the flexibility of a catheter, said device having an elongate member having a shaft having a selected region formed of a material having mechanical properties subject to change upon variation of said material'"'"'s operating temperature by a control means, the method comprising:

introducing said elongate member into the vasculature of the patient;

transporting said elongate member through the vasculature; and

communicating a temperature controlled fluid to the selected region of the shaft of the elongate member for varying the temperature of said selected region of the shaft of the elongate member without varying the temperature of an unselected region of the shaft of the elongate member to change the flexibility of said selected region without changing the flexibility of the unselected region.

12. The method of claim 11, wherein said control means includes heating means for increasing the operating temperature of said selected region of said elongate member.

13. The method of claim 12, wherein said heating means includes means for heating a fluid to a temperature in the range of 20°

C. to 70°

C.

14. A medical device for insertion into and transport through a patient'"'"'s vascular system, comprising:

an elongate member formed of material having mechanical properties subject to change upon variation of the temperature of the material, said elongate member having a shaft with a proximal portion and a distal portion;

means for communicating a temperature controlled fluid to a selected portion of the shaft of the elongate member for varying the temperature of the selected portion of the shaft of said elongate member without varying the temperature of an unselected portion of the shaft of said elongate member, whereby the mechanical properties of the selected portion of the shaft of said elongate member can be changed without changing the mechanical properties of the unselected portion of the shaft of said elongate member.

15. The mechanical device of claim 14, wherein said shaft has a first lumen extending therethrough, and said means for varying temperature comprises a second lumen extending through said first lumen, said first lumen having a proximal portion and a distal portion separated from said proximal portion by a plug, said second lumen being in fluid communication with a source of temperature controlled fluid, and said second lumen extending through said proximal portion, through said plug to said distal portion for communicating said temperature controlled fluid to said distal portion for varying the temperature of said distal portion without varying the temperature of said proximal portion.

16. The medical device of claim 15, wherein said distal portion carries a balloon, said second lumen being in fluid communication with said balloon for communicating said temperature controlled fluid to said balloon for varying the temperature of said balloon.