Methods and devices for sonographic imaging
View Patent ↗The present invention comprises methods and devices for providing contrast medium for sonography of structures such as ducts and cavities. The invention provides for creation of detectable acoustic variations between two generated phases of a gas and a liquid to make a contrast medium. Sonography is the primary means of imaging but other conventional detection modalities may also be employed with the present invention.
1. A saline and air contrast medium generating device, comprising:
a) a contrast pattern generating chamber having a first inlet port and a second inlet port and having a diameter similar to the diameter of the structure being observed and operable to maintain distinct interfaces between a gas and a fluid, wherein the gas and saline form a contrast medium having a multiply repeating pattern of discrete, alternating gas and fluid phases;
b) a container assembly
a first pre-filled container, pre-filled with a gas and operable to discharge the gas, the first pre-filled container coupled to a needle in fluidic communication with the contrast pattern generating chamber, wherein the needle extends into and is sealingly disposed in the contrast pattern generating chamber,
a second pre-filled container, pre-filled with saline and operable to discharge the saline, and in fluidic communication through a connection with the contrast pattern generating chamber, wherein the needle extends into the contrast pattern generating chamber a distance distal to the connection, and
first and second plungers, each plunger disposed within the respective first and second pre-filled containers, the first and second plungers capable of being depressed simultaneously to discharge the gas and saline from the respective first and second pre-filled containers to the contrast pattern generating chamber, wherein the gas phase is introduced into the saline phase to form the multiply repeating pattern of discrete, alternating gas and saline phases of the contrast medium; and
c) a catheter having the same diameter as and that forms a junction with the distal end of the contrast pattern generating chamber and is adapted to deliver the contrast medium directly into a structure to be visualized;
wherein the ratio of the diameter of the contrast generating chamber to a diameter of the structure to be visualized is from 0.3 to 1.8.
2. The device of claim 1 , wherein at least one of the first pre-filled container and the second pre-filled container comprises a pre-filled syringe.
3. The device of claim 2 , wherein the first pre-filled container and the second pre-filled container are the same volume.
4. The device of claim 1 , wherein the saline further comprises at least one of a surfactant, an emulsifier or a stabilizing agent.
5. The device of claim 1 , wherein the diameter of at least one of the contrast pattern generating chamber and the catheter are from 0.5 mm to 5.0 mm.
6. The device of claim 1 , wherein a delivery end of the catheter is further adapted to be placed in the cornua of the at least one Fallopian tube.
7. A method of sonographic visualization of a structure, comprising:
a. providing a contrast medium of multiply repeating alternating discrete phases of a gas and saline from a contrast medium generating device comprising:
i. a contrast pattern generating chamber having a diameter similar to the diameter of the structure being observed and operable to maintain distinct interfaces between a gas and saline, wherein the gas and the saline form a contrast medium having a multiply repeating pattern of discrete, alternating gas and saline phases;
ii. a container assembly comprising a first pre-filled container, pre-filled with a gas, and operable to discharge the gas, the first pre-filled container being coupled to a needle in fluidic communication with the contrast pattern generating chamber, wherein the needle extends into and is sealingly disposed in the contrast pattern generating chamber, a second pre-filled container, pre-filled with saline and operable to discharge the saline and in fluidic communication through a connection with the contrast pattern generating chamber, wherein the needle extends into the contrast pattern generating chamber a distance distal to the connection, and
first and second plungers, each plunger disposed within the respective first and second containers, the first and second plungers capable of being depressed simultaneously to discharge the gas and the saline from the respective first and second containers to the contrast pattern generating chamber, wherein the gas phase is introduced into the liquid phase to form the multiply repeating pattern of discrete, alternating gas and liquid phases of the contrast medium; and
iii. a catheter having the same diameter as, and that forms a junction with, the distal end of the contrast pattern generating chamber and is adapted to deliver the contrast medium directly into a structure;
wherein the ratio of the diameter of the contrast generating chamber to a diameter of the structure is from 0.3 to 1.8;
b. positioning the catheter in a uterus or at an opening of at least one Fallopian tube the structure;
c. simultaneously depressing the first and second plungers to form the contrast medium having the multiply repeating pattern of discrete alternating gas and liquid phases;
d. delivering the contrast medium to the uterus or at least one Fallopian tube or both structure; and
e. viewing the contrast medium in the structure using an ultrasonic imaging device.
8. The method of claim 7 , wherein a delivery end of the catheter is further adapted to be placed in the cornua of the at least one Fallopian tube.
9. The method of claim 7 , wherein the contrast medium further comprises a therapeutic agent.
10. The method of claim 7 , wherein at least one of the first pre-filled container and the second pre-filled container comprises a syringe.
11. The method of claim 7 , wherein the gas is air, carbon dioxide, oxygen, nitrogen, halocarbon compound gases, or a known contrast agent gas.