Contrast agent injection system for sonographic imaging

• US 9,554,826 B2
• Filed: 08/27/2011
• Issued: 01/31/2017
• Est. Priority Date: 10/03/2008
• Status: Active Grant

• Current Assignee: Femasys, Inc.
• Original Assignee: Femasys, Inc.
• Inventors: Lee-Sepsick, Kathy, Azevedo, Max S.
• Primary Examiner(s): Akar, Serkan
• Application Number:
  US13/219,667
• Publication Number:
  US 20120035471A1
• Time in Patent Office: 1,984 Days
• Field of Search: 600/432
• US Class Current: 1/1
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

The present invention comprises methods and devices for generating and providing contrast medium for sonography of structures such as ducts and cavities. The invention provides for creation of a contrast medium comprising detectable acoustic variations between two phases, for example, a gas and a liquid. Sonography is the primary imaging technique but other conventional detection techniques may also be employed with the present invention.

Claims

1. A method of sonographic visualization of a body structure, comprising,

a) providing a contrast medium generating and delivery device comprising a container assembly comprising a first and second syringe, the first syringe for containing saline and the second syringe, in fluid connection with an air port, for containing air or gas, first and second syringe plungers, respectively disposed within the first and second syringes for moving saline or air or gas into the syringe and for moving the contained saline or air or gas from the respective syringe, and connections for fluid connection of the first and second syringes to a contrast medium generating chamber comprising a static mixer, a pressure relief valve distal to and operably associated with the contrast medium generating chamber, and an exit port distal to the pressure relief valve;

b) simultaneously filling the first syringe with saline and the second syringe with air by placing the exit port in a container of saline and moving both syringe plungers in a proximal direction to draw saline into the first syringe and air or gas into the second syringe through the air port, wherein at least one one way check valve in fluid connection with the second syringe allows for only air or gas to enter the second syringe;

c) moving the saline and air or gas from the respective syringe to the contrast medium generating container to generate a contrast medium composition comprising saline and air or gas;

d) providing the contrast medium composition to a body structure via a catheter comprising a catheter delivery end positioned in the same or a different body structure; and

e) viewing the contrast medium composition in one or more body structures by ultrasound.

2. The method of claim 1, wherein step c) comprises providing saline and air to the contrast medium generating chamber wherein the saline and air are mixed to form the contrast medium composition comprising air segments and saline segments in a pattern of regular frequency.

3. The method of claim 1, wherein the contrast medium composition is provided to more than one body structure is viewed using ultrasound.

4. A method of diagnosing the patency of a fallopian tube, comprising,

a) providing a contrast medium generating and delivery device comprising a container assembly comprising a first and second syringe, the first syringe for containing saline and the second syringe for containing air or gas that is in fluid connection with an air port first and second syringe plungers, respectively disposed within the first or second syringe for moving or air into the syringe and for moving the contained saline or air from the respective syringe, and connections for fluid connection of the first and second syringes to a contrast medium generating chamber comprising a static mixer, a pressure relief valve distal to and operably associated with the contrast medium generating chamber, and an exit port distal to the pressure relief valve;

b) simultaneously filling the first syringe with saline and the second syringe with air by placing the exit port in a container of saline and moving both syringe plungers in a proximal direction to draw saline into the first syringe and air or gas into the second syringe through the air port, wherein at least one one way check valve in fluid connection with the second syringe allows for only air or gas to enter the second syringe;

c) moving the saline and air or gas from the respective syringe to the contrast medium generating container to generate a contrast medium composition comprising saline and air or gas;

d) providing the contrast medium composition to a uterus or at least one cornua of a fallopian tube via a catheter comprising a catheter delivery end positioned in the uterus or at least one cornua of a fallopian tube; and

e) viewing the contrast medium composition in the uterus or at least one fallopian tube by ultrasound.

5. The method of claim 4, wherein step c) comprises providing saline and air to the contrast medium generating chamber wherein the saline and air are mixed to form the contrast medium composition comprising air segments and saline segments in a pattern of regular frequency.

6. The method of claim 4, wherein the contrast medium composition is provided to the uterus and the at least one fallopian tubes and is viewed using ultrasound.