Ventilation imaging using a fine particle aerosol generator

• US 5,792,057 A
• Filed: 11/26/1997
• Issued: 08/11/1998
• Est. Priority Date: 05/21/1993
• Status: Expired due to Fees

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Farr, Stephen J., Rubsamen, Reid M.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US08/979,394
• Time in Patent Office: 258 Days
• Field of Search: 128/200.14, 128/203.12, 128/203.14-203.16, 128/203.24, 128/203.26, 128/203.27, 128/204.17, 128/205.29, 424/1.13, 600/431, 600/436
• US Class Current: 600/431
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61K 51/1206 Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling

Abstract

A method of diagnosing a patient is carried out by delivering an aerosolized dose of a radioactive formulation to a patient and making a ventilation image of radioactive material deposited in the lung. This image is compared with a separately generated image (perfusion image) taken after injecting radiolabled particles into the pulmonary arterial circulation. A diagnosis of a pulmonary embolism can be made when areas of the lung which are shown in the ventilation image are not shown within the perfusion image, indicating that air flow to that area exists, whereas a blood flow to that area has been blocked. Devices, packaging and methodology for creating aerosols are provided which allow for efficient and repeatable delivery of radioaerosols to the lungs of a patient. Devices may be plug-in units or hand-held, self-contained units which are automatically actuated at the same release point in a patient'"'"'s inspiratory flow cycle. The release point is automatically determined either mechanically or, more preferably calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a container of a radioactive formulation such as ^99m Tc-labelled diethylene-triamine pentaacetic acid (DTPA). Actuation of the device forces the radioactive formulation through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 6.0 microns. The container includes radioactive shielding in the form of a lead coating and/or a lead surrounding packet.

Claims

1. A method of creating an image, comprising:

moving a formulation of radioactive material from a container with a radiation seal through a porous membrane having pores with a diameter in a range of 0.5 to 6.0 microns in order to create aerosolized particles of radioactive material;

inhaling the particles into the lungs of a patient;

exposing a medium which is sensitive to radiation emitted by the radioactive material to the patient; and

processing the exposed medium to create an image.

2. The method of claim 1, further comprising:

heating air drawn toward the patient'"'"'s lungs along with the aerosolized particles wherein sufficient heat is added so as to evaporate the particles such that the particles are reduced in size by 25% or more before reaching the patient'"'"'s mouth.

3. The method of claim 1, wherein the moving is carried out through membrane pores having a diameter in the range of 1 to 3 microns.

4. The method of claim 1, wherein the moving is of formulation of radioactive material which is ^99m Tc-labelled diethylene triamine pentaacetic acid and the exposing is of a medium which is an electronic array sensitive to radiation emitted by the radioactive material.

5. The method of claim 1, further comprising:

measuring the inspiratory flow rate and inspiratory volume of the patient and moving the formulation through the porous membrane when the flow rate is in the range of about 0.1 to about 2.0 liters per second and the volume is in the range of about 0.15 to 2.0 liters.

6. The method of claim 5, wherein the moving is carried out when the flow rate is in the range of about 0.2 to about 1.8 liters per second, and the inspiratory volume is in the range of about 0.15 to about 0.8 liters.

7. The method of claim 6, wherein the moving is carried out when the inspiratory volume is in the range of about 0.15 to 0.4 liters.

8. The method of claim 5, wherein the measuring is carried out mechanically.

9. The method of claim 5, wherein the measuring is carried out electronically.

10. The method of claim 1, wherein the moving and inhaling steps are repeated using a new porous membrane with each moving step.

11. The method of claim 1, wherein the moving is through a porous flexible membrane which protrudes outward beyond a boundary layer of air flow created in a channel and the air is drawn over the protruded membrane to a channel end, via a substantially linear flow path.

12. The method of claim 1, further comprising:

adding energy to the aerosolized particles by actively heating air brought into contact with the particles.

13. The method of claim 12, wherein energy is added in an amount such that 50% or more of carrier in the particles when formed is evaporated prior to the particles being inhaled by the patient and wherein the energy is added by actively heating air by moving air through a heated material which material is heated prior to the inhaling.

14. The method of claim 12, wherein energy is added in an amount such that carrier is evaporated to the extent that the aerosolized particles of radioactive materials are substantially dry prior to inhaling the particles wherein the carrier is selected from the group consisting of water, ethanol and mixtures thereof, and further wherein the porous membrane includes from 10 to 10,000 pores over an area of from about 0.1 mm² to about 1 cm².

15. The method of claim 1, wherein the exposing is of a medium which is an electronic sensor array.

16. The method of claim 15, wherein the exposing is of an electronic sensor array within a gamma camera.

17. The method of claim 1, wherein the formulation of radioactive material is moved through the porous membrane using ultrasonic vibrations.

18. A method of creating an image, comprising:

measuring a patient'"'"'s inspiratory flow rate and inspiratory volume;

releasing aerosolized particles of radioactive formulation from a container with a radiation seal to the patient when the patient'"'"'s inspiratory flow rate is in the range of about 0.1 to about 2.0 liters per second and the patient'"'"'s inspiratory volume is in the range of about 0.15 to about 2 liters;

inhaling the aerosolized radioactive particles into the lungs of the patient;

exposing a medium which is sensitive to radiation emitted by radioactive particles in the lung to the lungs of the patient;

processing the exposed medium to create an image.

19. The method of claim 18, wherein the releasing is of aerosolized particles having a diameter in the range of 0.5 micron to about 12 microns and the recording medium is an electronic array sensitive to radiation emitted by the radioactive material.

20. The method of claim 18, wherein the releasing is of radioactive material which is ^99m Tc-labelled diethylene triamine pentaacetic acid.