Cryogenic catheter

• US 5,281,215 A
• Filed: 06/15/1992
• Issued: 01/25/1994
• Est. Priority Date: 04/16/1992
• Status: Expired due to Term

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Implemed, Inc.
• Inventors: Milder, Fredric L.
• Primary Examiner(s): ASCHENBRENNER, PETER
• Application Number:
  US07/898,142
• Time in Patent Office: 589 Days
• Field of Search: 606/20-26
• US Class Current: 606/20
• 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 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 18/28 for heating a thermal probe or absorber
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0275 : using porous elements
• CPC Class Codes: A61B 2018/0281 : using a tortuous path, e.g. formed by fins or ribs
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/003 : using a spray or a foam
• CPC Class Codes: A61F 2007/0056 : for cooling
• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

The invention provides a catheter for ice mapping and ablation and a method of ablation using the catheter. The catheter includes at least two lumens for circulating a refrigerating fluid adjacent an ablation device located at the end of a catheter. The refrigerated ablation device is used to chill a localized region of myocardial tissue, thereby permitting the resulting change in electrical activity to be determined. In response to the test results, the ablation device may be used to make a lesion in the myocardial tissue to correct a cardiac arrhythmia. In one embodiment, the ablation device is an electrode which uses radio frequency energy to ablate the myocardial tissue. Alternatively, the ablation device is an electrode adapted for direct current ablation. In another embodiment, the electrode is replaced with an optical fiber in communication with a laser which uses the laser'"'"'s light energy to ablate tissue. Yet another embodiment is a cryogenic catheter, useful for cooling tissue for other applications, for use as combined or separate mapping and ablation devices, or for use with the ice mapping and ablation means of the present invention. The embodiments may include provisions for steering the catheter and for stabilizing the ablation device at the proposed lesion site.

Claims

1. A cryogenic catheter comprising:

a first lumen;

a second lumen;

a valve associated with one of said lumens, said valve regulating flow of a cooling fluid between said first lumen and said second lumen, wherein said valve comprises a ball biased against a ball seat with a biasing means, said ball preventing flow of said cooling fluid through a passage within said ball seat until said cooling fluid exerts sufficient pressure against said ball to overcome bias forces imparted thereon, thereby displacing said ball from said ball seat; and

a chamber for permitting said cooling fluid to boil, cool, and thereby chill a tissue cooling surface located proximate said chamber, said cooling fluid introduced into said chamber through said valve by way of said first lumen and exhausted from said chamber via said second lumen.

2. A cryogenic catheter comprising:

a first lumen, having a proximal end and a distal end, concentric with a second lumen, said first lumen permitting a cooling fluid to flow from said proximal end to said distal end, said second lumen, having a proximal end and a distal end, permitting said cooling fluid to flow from said distal end to said proximal end, said first lumen concentric with said second lumen being sufficiently flexible and sufficiently narrow to be inserted into and travel through a cardiac blood vessel without injuring said cardiac blood vessel;

at least one control valve for regulating flow of said cooling fluid from said distal end of said first lumen into a boiling chamber that connects said distal end of said first lumen and said distal end of said second lumen, said boiling chamber permitting boiling of said cooling fluid into a gaseous state, wherein said control valve has an open and a closed state, for permitting said cooling fluid to pass from said first lumen into said boiling chamber when said at least one control valve is in said open state, said at least one control valve responsive to an electric control signal; and

a plurality of temperature sensors for producing said electric control signal, including a temperature sensor located within said second lumen; and

a cooling surface proximate said boiling chamber, wherein said cooling surface is a thermal conductor.

3. The catheter of claim 2, further comprising a micropore filter positioned within said second lumen to prevent said cooling fluid in a liquid state from exiting said proximal end of said second lumen.

4. The catheter of claim 3, wherein said micropore filter is a plug of glass wool that substantially fills said distal end of said second lumen.

5. The catheter of claim 3, wherein said micropore filter is sponge that substantially fills said distal end of said second lumen.

9. The catheter of claim 2, wherein said at least one control valve comprises a needle valve.

10. The catheter of claim 2, wherein said at least one control valve comprises a solenoid valve.

11. The catheter of claim 2, wherein said plurality of temperature sensors comprises at least one thermocouple.

12. The catheter of claim 2, wherein said plurality of temperature sensors comprises at least one thermistor.

6. A cryogenic catheter comprising:

a first lumen, having a proximal end and a distal end, concentric with a second lumen, said first lumen permitting a cooling fluid to flow from said proximal end to said distal end, said second lumen, having a proximal end and a distal end, permitting said cooling fluid to flow from said distal end to said proximal end;

at least one control valve for regulating flow of said cooling fluid from said distal end of said first lumen into a boiling chamber that connects said distal end of said first lumen and said distal end of said second lumen, said boiling chamber permitting boiling of said cooling fluid into a gaseous state, said at least one control valve comprising;

a ball seat;

a ball, matable with said ball seat for forming a fluid tight seal, said ball seat having a passage therein for permitting said cooling fluid to pass from said first lumen into said boiling chamber when said ball is displaced; and

a biasing means, for biasing said ball toward said ball seat, said biasing means causing said ball to mate with said ball seat until said cooling fluid is pressurized to a predetermined pressure level; and

a cooling surface proximate said boiling chamber, wherein said cooling surface is a thermal conductor.

7. The catheter of claim 6, wherein said biasing means is a spring.

8. The catheter of claim 6, wherein said biasing means is a compressible pad.

13. A cryogenic catheter comprising:

a first lumen, having a proximal end and a distal end, concentric with a second lumen, said first lumen permitting a cooling fluid to flow from said proximal end to said distal end, said second lumen, having a proximal end and a distal end, permitting said cooling fluid to flow from said distal end to said proximal end;

a fluid control valve comprising an electrically controlled valve, said fluid control valve having an open and a closed state for permitting said cooling fluid to pass from said first lumen into a boiling chamber when said fluid control valve is in said open state, said boiling chamber connecting said distal end of said first lumen and said distal end of said second lumen, said boiling chamber permitting boiling of said cooling fluid into a gaseous state;

a cooling surface proximate said expansion chamber, wherein said cooling surface is thermal conductor;

a micropore filter positioned within said second lumen to prevent said cooling fluid in a liquid state from exiting said proximal end of said second lumen; and

at least one temperature sensor for producing an electric control signal to command said fluid control valve into said open and said closed states.

14. A cryogenic catheter comprising:

a first lumen, having a proximal end and a distal end, concentric with a second lumen, said first lumen permitting a cooling fluid to flow from said proximal end to said distal end, said second lumen, having a proximal end and a distal end, permitting said cooling fluid to flow from said distal end to said proximal end;

a fluid control valve comprising;

a ball seat;

a ball matable with said ball seat for forming a fluid tight seal, said ball seat having a passage therein for permitting said cooling fluid to pass from said first lumen into a boiling chamber when said ball is displaced, said boiling chamber connecting said distal end of said first lumen and said distal end of said second lumen, said boiling chamber permitting boiling of said cooling fluid into a gaseous state; and

a biasing means, for biasing said ball toward said ball seat, said biasing means causing said ball to mate with said ball seat until said cooling fluid is pressurized to a predetermined pressure level;

a cooling surface proximate said boiling chamber and responsive to thermal activity therein;

a micropore filter positioned within said second lumen to prevent said cooling fluid in a liquid state from exiting said proximal end of said second lumen; and

at least one temperature sensor for producing an electric control signal to command said fluid control valve into open and closed states.

15. A method of cryoablation comprising the steps of:

introducing a cryogenic catheter into a cardiac blood vessel, said cryogenic catheter having a proximal end and a distal end, said cryogenic catheter comprising;

a first lumen for permitting a cooling fluid to flow from said proximal end to said distal end;

a second lumen permitting return of said cooling fluid from said distal end to said proximal end;

a valve associated with one of said lumens, said valve regulating flow of said cooling fluid between said first lumen and said second lumen, said valve responsive to at least one electric control signal;

a temperature sensor located within said second lumen for providing one of said at least one electric control signal;

positioning said distal end of said cryogenic catheter at a proposed lesion site;

introducing a cooling fluid into said first lumen to cool said distal end and thereby cool said proposed lesion site to suppress localized cardiac electrical activity;

monitoring the temperature within said second lumen with said temperature sensor;

testing said proposed lesion site for cardiac activity using electrocardiographic mapping means;

evaluating results of said test to confirm effectiveness of said proposed lesion site; and

generating a lesion by cryoablation.

16. A method of cryoablation comprising the steps of:

introducing a cryogenic catheter into a cardiac blood vessel, said cryogenic catheter having a proximal end and a distal end, said cryogenic catheter comprising;

a first lumen for permitting a cooling fluid to flow from said proximal end to said distal end;

a second lumen permitting return of said cooling fluid from said distal end to said proximal end;

a valve associated with one of said lumens, said valve regulating flow of said cooling fluid between said first lumen and said second lumen, said valve responsive to at least one electric control signal;

a first temperature sensor located within said second lumen for monitoring the temperature within said second lumen, said first temperature sensor providing one of said at least one electric control signal;

a second temperature sensor positioned to monitor thermal activity proximate said distal end, said second temperature sensor providing one of said at least one electric control signal;

positioning said distal end of said cryogenic catheter at a proposed lesion site;

introducing a cooling fluid into said first lumen to cool said distal end and thereby cool said proposed lesion site to suppress localized cardiac electrical activity;

monitoring the temperature within said second lumen with said temperature sensor;

testing said proposed lesion site for cardiac activity using electrocardiographic mapping means;

evaluating results of said test to confirm effectiveness of said proposed lesion site; and

generating a lesion by cryoablation.