Cryosurgical probe with bellows shaft

• US 6,767,346 B2
• Filed: 01/23/2002
• Issued: 07/27/2004
• Est. Priority Date: 09/20/2001
• Status: Expired due to Term

• Current Assignee: Endocare Inc. (Siemens AG)
• Original Assignee: Endocare Inc. (Siemens AG)
• Inventors: Bui, Dennis M., Yu, Xiaoyu, Damasco, Sanford D.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US10/057,033
• Publication Number:
  US 20030055416A1
• Time in Patent Office: 916 Days
• Field of Search: 606/20-26, 607/96, 607/105, 607/113
• US Class Current: 606/21
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid

Abstract

The malleable cryosurgical probe includes a cryostat assembly and a cryoprobe assembly. The cryostat assembly includes an elongated shaft assembly having a bellows portion thereof and a closed distal end. The shaft assembly includes at least one freezing portion comprising the bellows portion, at least one thermally insulated portion and a thermally insulating element positioned about the thermally insulated portion. A cryostat is operably associated with the elongated shaft assembly. It includes a cryostat inlet for receiving gas entering the cryostat, a cryostat outlet and a heat exchanger positioned between the cryostat outlet and the cryostat inlet. The heat exchanger receives gas from the cryostat inlet and provides heat transfer between gas flowing within the cryostat and fluid exterior thereto. At least one Joule-Thomson nozzle is in fluid communication with the cryostat outlet. The at least one Joule-Thomson nozzle expands gas expelled therefrom. The expanded cold fluid communicates with the freezing portion to provide cooling thereof. The cryoprobe assembly includes a handle assembly for supporting the cryostat assembly and a fluid supply line assembly connectable to a fluid source at one end and to the cryostat inlet at a second end. The heat exchanger is positioned at a location longitudinally spaced from the freezing portion(s).

Claims

1. A malleable cryosurgical probe, comprising:

a cryoassembly for providing a flow of cryogenic fluid, said cryoassembly comprising a plurality of longitudinally spaced Joule-Thomson nozzles; and

,

a malleable shaft secured to and in heat transfer relationship with said cryoassembly, said shaft having a hydroformed bellows portion located thereon formed of a thermally conductive metal, said bellows portion having a plurality of convolutions, said convolutions having outer diameters in a range of 0.140-0.180 inches and inner diameters in a range of 0.065-0.100 inches, said bellows portion having a minimum bend radius of about 0.195 inches, said convolutions each comprise peak sections and valley sections, said peak sections each having peaks, said convolutions being spaced in a range of 0.020-0.100 inches, peak-to-peak, wherein each convolution has a wall thickness in a range of 0.0015 to 0.0122 inches and wherein said bellows portion is bendable and will hold form as desired by the operator.

2. The malleable cryosurgical probe of claim 1, wherein said convolutions each comprise alternating peak sections and valley sections, said peak sections each having peaks, said convolutions being spaced by a distance of approximately 0.030 inches, peak-to-peak.

3. The malleable cryosurgical probe of claim 1, wherein said convolutions each comprise alternating peak sections and valley sections, each valley section defining a valley radius and each peak section defining a peak radius, the summation of said valley radius and said peak radius being one-half the peak-to-peak distance between convolutions.

4. The malleable cryosurgical probe of claim 1, wherein said shaft comprises a tip portion at a distal end thereof wherein the distance between a tip of said tip portion and said bellows portion is no more than 1½

times the outer diameters of said convolutions.

5. The malleable cryosurgical probe of claim 1, wherein said cryoassembly comprises a sliding assembly including a sliding element attached to a thermal insulating element for selectively effecting the location of the freezing zone.

6. The malleable cryosurgical probe of claim 1 wherein said bellows portion has a length in a range of 1.4 inches to about 4.0 inches.

7. The malleable cryosurgical probe of claim 1 wherein said cryogenic fluid is introduced to said Joule-Thomson nozzles at a rate of between about 2000 psi to about 4500 psi.

8. A malleable cryosurgical probe, comprising:

a) a cryostat assembly, comprising;

i) an elongated shaft assembly having at least one malleable hydroformed bellows portion thereof and a closed distal end, said shaft assembly, including;

at least one freezing portion comprising said at least one bellows portion;

at least one thermally insulated portion; and

,

a thermally insulating element positioned about said thermally insulated portion;

ii) a cryostat operably associated with said elongated shaft assembly, comprising;

a cryostat inlet for receiving gas entering said cryostat;

a cryostat outlet; and

,

a heat exchanger positioned between said cryostat outlet and said cryostat inlet, said heat exchanger for receiving gas from said cryostat inlet and providing heat transfer between gas flowing within said cryostat and fluid exterior thereto; and

,

iii) a plurality of longitudinally spaced Joule-Thomson nozzles in fluid communication with said cryostat outlet, said plurality of Joule-Thomson nozzles for expanding gas expelled therefrom, the expanded cold fluid communicating with said at least one freezing portion to provide cooling thereof; and

,

b) a cryoprobe assembly, comprising;

a handle assembly for supporting said cryostat assembly; and

,

a fluid supply line assembly connectable to a fluid source at one end and to said cryostat inlet at a second end,

wherein said heat exchanger is positioned at a location longitudinally spaced from said at least one freezing portion

wherein said bellows portion is formed of a thermally conductive metal, said bellows portion having a plurality of convolutions, said convolutions having outer diameters in a range of 0.140-0.180 inches and inner diameters in a range of 0.065-0.100 inches, said bellows portion having a minimum bend radius of about 0.195 inches, said convolutions each comprise peak sections and valley sections, said peak sections each having peaks, said convolutions being spaced in a range of 0.020-0.100 inches, peak-to-peak, wherein each convolution has a wall thickness in a range of 0.0015 to 0.0122 inches and wherein said bellows portion is bendable and will hold form as desired by the operator.

9. The malleable cryosurgical probe of claim 8, wherein said convolutions each comprise alternating peak sections and valley sections, said peak sections each having peaks, said convolutions being spaced by a distance of approximately 0.030 inches, peak-to-peak.

10. The malleable cryosurgical probe of claim 8, wherein said convolutions each comprise alternating peak sections and valley sections, each valley section defining a valley radius and each peak section defining a peak radius, the summation of said valley radius and said peak radius being one-half the peak-to-peak distance between convolutions.

11. The malleable cryosurgical probe of claim 8, wherein said cryostat assembly comprises a sliding assembly including a sliding element attached to said thermally insulating element for selectively effecting the location of the freezing zone.

12. The malleable cryosurgical probe of claim 8, wherein said handle assembly defines a volume formed therein, said heat exchanger being positioned within said volume.

13. The malleable cryosurgical probe of claim 8, wherein said thermally insulating element is adjustably positionable to control the location, size and shape of said freezing portion.