Hyperpolarized gas containers, solenoids, transport and storage devices and associated transport and storage methods

• US 6,269,648 B1
• Filed: 06/16/1999
• Issued: 08/07/2001
• Est. Priority Date: 06/17/1998
• Status: Expired due to Fees

• Current Assignee: Polarean, Inc. (Polarean Imaging Plc)
• Original Assignee: Medi-Physics Incorporated (General Electric Company)
• Inventors: Hasson, Kenton C., Zollinger, Geri T. K., Zollinger, David L., Wheeler, Bradley A., Bogorad, Paul L.
• Primary Examiner(s): CAPOSSELA, RONALD C
• Application Number:
  US09/333,571
• Time in Patent Office: 783 Days
• Field of Search: 62/31, 62/451, 629/14
• US Class Current: 62/3.1
• CPC Class Codes: A61K 49/1815 compo-inhalant, e.g. breath tests
• CPC Class Codes: F17C 1/00 Pressure vessels, e.g. gas cylinder, gas tank, replaceable cartridge pressurised apparatus for purposes other than storage, see the relevant subclasses such as A62C, B05B; associated with vehicles, see the appropriate subclass of classes B60 - B64; pressure vessels in general F16J12/00 ; autoclaves B01J3/04; tank vehicles B60P3/22; railway tank wagons for carrying fluent materials B61D5/00; accumulators for supplying fluid under pressure F15B1/04; liquefied gas stoves F24C3/00
• CPC Class Codes: F17C 13/002 for vessels under pressure F17C13/008 and F17C13/02 - F17C13/12 take precedence
• CPC Class Codes: F17C 13/005 for medium-size and small storage vessels not under pressure F17C13/008 and F17C13/02 - F17C13/12 take precedence
• CPC Class Codes: F17C 2201/0128 spherical or elliptical
• CPC Class Codes: F17C 2201/0176 variable
• CPC Class Codes: F17C 2201/058 portable (<30 l)
• CPC Class Codes: F17C 2203/0604 Liners
• CPC Class Codes: F17C 2203/0607 Coatings
• CPC Class Codes: F17C 2203/0629 Two walls
• CPC Class Codes: F17C 2203/0636 Metals
• CPC Class Codes: F17C 2203/0646 Aluminium
• CPC Class Codes: F17C 2203/066 Plastics
• CPC Class Codes: F17C 2203/0685 flexible
• CPC Class Codes: F17C 2203/0697 comprising nanoparticles
• CPC Class Codes: F17C 2205/0134 characterised by the presence of fluid connection between vessels
• CPC Class Codes: F17C 2205/0323 Valves
• CPC Class Codes: F17C 2205/035 Flow reducers
• CPC Class Codes: F17C 2205/0352 Pipes
• CPC Class Codes: F17C 2205/0382 Constructional details of valves, regulators
• CPC Class Codes: F17C 2221/07 : Hyperpolarised gases
• CPC Class Codes: F17C 2223/0123 : gaseous, e.g. CNG, GNC
• CPC Class Codes: F17C 2223/035 : High pressure (>10 bar)
• CPC Class Codes: F17C 2225/0123 : gaseous, e.g. CNG, GNC
• CPC Class Codes: F17C 2225/035 : High pressure, i.e. between 10 and 80 bars
• CPC Class Codes: F17C 2227/041 : vessel by vessel
• CPC Class Codes: F17C 2227/044 : by purging
• CPC Class Codes: F17C 2250/032 : using computers
• CPC Class Codes: F17C 2250/0404 : Parameters indicated or measured
• CPC Class Codes: F17C 2250/0491 : Parameters measured at or inside the vessel
• CPC Class Codes: F17C 2260/012 : Reducing weight
• CPC Class Codes: F17C 2260/026 : by calculation
• CPC Class Codes: F17C 2260/03 : Dealing with losses
• CPC Class Codes: F17C 2270/02 : for medical applications
• CPC Class Codes: F17C 2270/0536 : Magnetic resonance imaging
• CPC Class Codes: F17C 3/00 : Vessels not under pressure
• CPC Class Codes: G01R 33/282 : Means specially adapted for hyperpolarisation or for hyperpolarised contrast agents, e.g. for the generation of hyperpolarised gases using optical pumping cells, for storing hyperpolarised contrast agents or for the determination of the polarisation of a hyperpolarised contrast agent
• CPC Class Codes: Y10S 62/914 : Magnetic or electric field

Abstract

A compact portable transport unit for shipping hyperpolarized noble gases and shielding same from electromagnetic interference and/or external magnetic fields includes a means for shifting the resonance frequency of the hyperpolarized gas outside the bandwidth of typical frequencies associated with prevalent time-dependent fields produced by electrical sources. Preferably the transport unit includes a magnetic holding field which is generated from a solenoid in the transport unit. The solenoid includes a plurality of coil segments and is sized and configured to receive the gas chamber of a container. The gas container is configured with a valve, a spherical body, and an extending capillary stem between the valve and the body. The gas container or hyperpolarized product container can also be formed as a resilient bag. The distribution method includes positioning a multi-bolus container within the transport unit to shield it and transporting same to a second site remote from the first site and subsequently dispensing into smaller patient sized formulations which can be transported (shielded) in another transport unit to yet another site.

Claims

1. A transport unit for transporting hyperpolarized gas products therein, said transport unit comprising:

at least one gas chamber configured to hold a quantity of hyperpolarized gas product therein; and

an electromagnet disposed in said transport unit, said electromagnet configured and sized to define a magnetic holding field having at least one region of homogeneity therein,

wherein a major portion of each of said at least one gas chamber is sized and configured to reside in said magnetic field homogeneous region.

2. A transport unit according to claim 1, further comprising at least one electrical current carrying wire, wherein said at least one electrical wire is configured to generate at least a portion of said magnetic holding field.

3. A transport unit according to claim 1, wherein said electromagnet comprises at least one cylindrical solenoid.

4. A transport unit according to claim 3, wherein said at least one solenoid and gas chamber is a plurality of corresponding solenoids and gas chambers for transporting multiple doses of hyperpolarized gas products therein.

5. A transport unit according to claim 3, wherein said at least one gas chamber is a plurality of separate gas chambers.

6. A transport unit according to claim 3, wherein said solenoid comprises a plurality of coil segments thereon.

7. A transport unit according to claim 6, wherein said operating circuitry is configured to allow an adjustable amount of current to said solenoid thereby providing an adjustable magnetic holding field strength.

8. A transport unit according to claim 6, wherein said plurality of coil segments includes spatially separated first, second, and third coil segments.

9. A transport unit according to claim 3, said transport unit further comprising a metallic enclosure, wherein said solenoid is positioned in said enclosure such that it extends longitudinally therein.

10. A transport unit according to claim 9, wherein said enclosure includes at least one layer of an electrically conducting metal thereon, thereby providing one or more of shielding from external electromagnetic radiation and structural support during transport.

11. A transport unit according to claim 3, wherein said solenoid provides a homogeneous magnetic holding field volume defined relative to the center of said solenoid, and wherein said container has a hyperpolarized product holding chamber configured and sized such that said holding chamber is held in said homogeneous field volume.

12. A transport unit according to claim 9, wherein said enclosure includes at least one layer of magnetically permeable material to provide at least one of additional electromagnetic shielding, DC magnetic shielding, or a flux return.

13. A transport unit according to claim 3, further comprising operating circuitry operably associated with said transport unit, said operating circuitry including a direct current power supply operably associated with said solenoid.

14. A transport unit according to claim 13, wherein said operating circuitry is configured to direct electrical current to said solenoid to define the magnetic holding field having a field strength corresponding to the amount of current directed to said solenoid.

15. A transport unit according to claim 10, wherein said solenoid is disposed in said transport unit such that it longitudinally extends in said enclosure and defines a magnetic holding field which is substantially aligned with the earth'"'"'s magnetic field.

16. A transport unit according to claim 8, wherein said second coil segment is disposed intermediate said first and third coil segments, and wherein said second coil segment has a lower number of electrical windings per unit length then said first and third coil segments.

17. A transport unit according to claim 16, wherein said first and third coil segments extend a first longitudinal distance along said solenoid and said second coil segment extends a second longitudinal distance along said solenoid, and wherein said second distance is greater than said first and third distance.

18. A transport unit according to claim 1, wherein said gas chamber includes a gas holding chamber having a major body portion with a first length and a capillary stem with a second length, said capillary stem is in fluid communication with said gas holding chamber and having a capillary length and a capillary diameter, wherein said capillary length is greater than said major body portion length.

19. A transport unit according to claim 1, wherein said gas chamber is defined by at least one resilient bag defining at least one expandable gas holding chamber.

20. A transport unit according to claim 19, wherein said at least one gas chamber is a plurality of gas chambers defined by a plurality of resilient bags for transporting multiple separate doses of hyperpolarized products therein.

21. A transport unit according to claim 20, further comprising a tray for holding said plurality of bags, said tray configured and sized to reside within said magnetic field generator.

22. A system of extending the polarization lifetime of hyperpolarized gas during transport, comprising the steps of:

introducing a quantity of hyperpolarized gas product into a sealable gas chamber at a production site;

capturing a quantity of hyperpolarized gas product in the gas chamber;

generating a magnetic holding field from a portable transport unit, thereby defining a substantially homogeneous magnetic holding region therein;

positioning a major portion of the gas chamber within the homogeneous holding region;

transporting the captured hyperpolarized gas in the gas chamber; and

shielding the hyperpolarized gas product to minimize the depolarizing effects of external magnetic fields during said transporting step such that the hyperpolarized gas has a clinically useful polarization level at a site remote from the production site.

23. A hyperpolarized gas protection system according to 22, wherein said transport unit comprises a metallic enclosure, and wherein said step of shielding is performed by positioning said gas chamber in the metallic enclosure and electrically activating a solenoid disposed in the metallic enclosure.

24. A hyperpolarized gas protection system according to 22, wherein said shielding step comprises shifting the normal resonant frequency of the hyperpolarized gas outside a predetermined frequency range.

25. A hyperpolarized gas protection system according to 22, wherein the transport unit is configured to hold a plurality of separate gas chambers therein.

26. A method according to 22, wherein the transporting step is performed by transporting the gas chamber to a second site remote from the production site.

27. A method according to claim 26, wherein the gas chamber is configured as a multi-dose container, and further comprising the step of distributing the transported hyperpolarized gas in the multi-dose container at the second site into a plurality of single-dose containers to provide a suitable amount of hyperpolarized gas product therein.

28. A method according to claim 27, further comprising the steps of transporting said plurality of said single dose containers to a third site remote from the second site;

administering the hyperpolarized product held in at least one of said single dose containers to a patient; and

obtaining an MR imaging or spectroscopy signal associated with same.

29. A method for distributing hyperpolarized noble gas, comprising the steps of:

polarizing noble gas at a polarization site;

capturing a quantity of polarized gas in a multi-dose container, the quantity of hyperpolarized gas being sufficient to provide a plurality of doses of a hyperpolarized product;

positioning the first multi-dose container within a portable transport unit, the transport unit configured to provide a homogeneous magnetic field proximate to a major portion of the multi-dose container held therein;

transporting the transport unit with the multi-dose container to a second site remote from the polarization site; and

distributing the hyperpolarized gas held in the multi-dose container into multiple separate second containers at the second site.

30. A method according to claim 29, wherein said transporting step comprises shielding said hyperpolarized gas by activating an electromagnet in said portable transport unit.

31. A method according to claim 29, further comprising the steps of sub-dividing the hyperpolarized gas in the first multi-dose container at the second site;

and processing the sub-divided gas into at least one desired formulation to form a hyperpolarized pharmaceutical product suitable for in vivo administration, the processing step being performed prior to said distributing step.

32. A method according to claim 31, further comprising the steps of:

positioning at least one of the multiple separate second containers with the hyperpolarized gas product therein into a second transport unit, the second transport unit being configured to provide a region of homogeneity therefor; and

transporting the second transport unit with the at least one multiple separate second container to a third site.

33. A method according to claim 32, wherein at least one of the multiple separate second containers comprises a patient dose sized resilient bag.

34. A method according to claim 33, further comprising the steps of:

administering said hyperpolarized pharmaceutical product in said second container to a patient; and

obtaining clinically useful data associated with the administered hyperpolarized product via one or more of an Magnetic Resonance Imaging or Spectroscopy procedures.

35. A method according to claim 31, further comprising the steps of:

positioning a plurality of patient-sized bags filled with the hyperpolarized pharmaceutical product in said second transport unit; and

transporting the plurality of patient sized bags to a third site remote from the second site.

36. A method according to claim 29, wherein the hyperpolarized gas comprises ³He, and wherein the multi-bolus container is used to polarize a quantity of noble gas therein during said polarizing step at the polarization site.

37. A portable transporter for transporting or storing a quantity of hyperpolarized gas product, comprising:

an enclosure having at least one wall with a skin depth of a conductive shielding material configured to provide a shield for a quantity of hyperpolarized gas from externally generated electromagnetic interference during transport from a polarization site to a use site, said enclosure defining a holding volume therebetween;

at least one hyperpdlarized gas container positioned in said enclosure, said gas container having a major gas holding volume portion, and

a magnetic field source positioned in said enclosure, said magnetic field source configured to provide a region of homogeneity proximate to said hyperpolarized gas container;

wherein the holding volume is sized and configured to hold said hyperpolarized gas container such that the major volume of said hyperpolarized gas container is spatially separated a predetermined distance from adjacent portions of said at least one wall, and wherein said predetermined distance is sufficient to increase the shielding effectiveness of said enclosure.

38. A portable transporter according to claim 37, wherein said at least one wall comprises a pair of opposing longitudinally extending walls.

39. A portable transport unit according to claim 37, wherein said magnetic field source is a solenoid.

40. A portable transport unit according to claim 39, wherein said solenoid comprises a conductive material inner surface configured to provide shielding.

41. A portable transport unit according to claim 37, wherein said predetermined separation distance is at least about 2.0 inches.

42. A portable transport unit according to claim 37, wherein said at least one gas container is a plurality of gas containers.

43. A portable transport unit according to claim 37, wherein said at least one gas container comprises a container which is also configured as an optical pumping cell for the hyperpolarized gas held therein at a polarization site.

44. A portable transport unit according to claim 37, wherein said predetermined separation distance provides a separation ratio of less than about 0.60, the separation ratio being mathematically expressed by the ratio of (a) the linear lateral half-width of the major volume portion of said gas container to (b) the linear minimum separation distance of said at least one wall.

45. A portable transport unit according to claim 37, wherein said magnetic field source is a plurality of electromagnetic field sources, at least one each for each of said at least one containers held in said enclosure.

46. A portable transport unit according to claim 37, wherein said at least one container comprises a capillary stem.