Detailed Analysis of the Scope and Claims of United States Patent 10,232,061
Introduction
United States Patent 10,232,061, issued on March 19, 2019, is a significant patent in the field of medical diagnostics, particularly related to ultrasound contrast agents. This patent is held by Bracco Suisse SA and pertains to a freeze-dried formulation for gas-filled microvesicles, which are crucial in enhancing ultrasound imaging.
Background
The patent revolves around the development of a specific formulation for gas-filled microvesicles, which are used as ultrasound contrast agents. These agents, such as sulfur hexafluoride (marketed under the brand name Lumason), are essential for improving the quality of ultrasound images, especially in echocardiography and ultrasonography of the liver[1][2].
Scope of the Patent
Freeze-Dried Formulation
The patent describes a freeze-dried powder composition that includes a phospholipid and a polyethylene glycol. The polyethylene glycol in this composition has a percentage of folded polymeric chains of 40% or higher. This specific formulation is designed to prepare gas-filled microvesicles, which are critical for the enhancement of ultrasound signals[2][5].
Application in Ultrasound Imaging
The gas-filled microvesicles produced from this formulation are used to enhance the visibility of blood vessels and the urinary tract during ultrasound procedures. Specifically, they are indicated for use in echocardiography to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border in adult patients with suboptimal echocardiograms. They are also used in ultrasonography of the liver to characterize focal liver lesions in both adult and pediatric patients[1].
Claims of the Patent
Key Components
The patent claims cover several key components of the formulation:
- Phospholipid and Polyethylene Glycol: The composition includes a phospholipid and a polyethylene glycol with a specific percentage of folded polymeric chains, which is crucial for the stability and efficacy of the microvesicles[2][5].
- Freeze-Dried Powder: The formulation is in the form of a freeze-dried powder, which is reconstituted before use. This form ensures the stability and shelf life of the product[2].
Manufacturing Process
The patent also covers the manufacturing process of the freeze-dried formulation, including the steps involved in preparing the gas-filled microvesicles. This includes the combination of the phospholipid and polyethylene glycol, the freeze-drying process, and the reconstitution of the powder before administration[5].
Use in Medical Procedures
The claims extend to the use of these microvesicles in medical procedures, specifically in ultrasound imaging. This includes their application in echocardiography and liver ultrasonography, highlighting their role in enhancing image quality and diagnostic accuracy[1].
Patent Landscape
Exclusivity and Protection
The patent provides Bracco Suisse SA with exclusive rights to the proprietary chemical formulation and manufacturing process for a period that is estimated to expire on July 6, 2038. This exclusivity is crucial for protecting the intellectual property and ensuring that the company maintains a competitive edge in the market[2].
Related Patents
There are other related patents held by Bracco Suisse SA, such as US Patent 10,335,502 and US Patent 11,723,869, which also pertain to similar formulations and manufacturing processes. These patents collectively strengthen the company's intellectual property portfolio in the field of ultrasound contrast agents[2].
Impact on the Medical Field
Enhanced Diagnostic Capabilities
The formulation described in this patent has significantly enhanced the diagnostic capabilities of ultrasound imaging. By providing clearer images of blood vessels and liver lesions, it aids in more accurate diagnoses and treatment plans[1].
Patient Safety
The specific composition and manufacturing process ensure the safety and efficacy of the product, reducing the risk of adverse reactions and improving patient outcomes.
Conclusion
United States Patent 10,232,061 is a critical patent in the medical diagnostics sector, particularly in the development and use of ultrasound contrast agents. The scope and claims of this patent protect a unique formulation and manufacturing process that enhance the quality of ultrasound images, thereby improving diagnostic accuracy and patient care.
Key Takeaways
- Freeze-Dried Formulation: The patent covers a freeze-dried powder composition including a phospholipid and polyethylene glycol.
- Ultrasound Imaging: The formulation is used to enhance ultrasound images in echocardiography and liver ultrasonography.
- Exclusive Rights: The patent provides Bracco Suisse SA with exclusive rights until July 6, 2038.
- Related Patents: Other patents held by Bracco Suisse SA strengthen their intellectual property portfolio.
- Diagnostic Enhancement: The formulation improves diagnostic accuracy and patient outcomes.
FAQs
What is the main purpose of United States Patent 10,232,061?
The main purpose of this patent is to protect a specific freeze-dried formulation for gas-filled microvesicles used as ultrasound contrast agents.
Who holds this patent?
This patent is held by Bracco Suisse SA.
What is the expiration date of this patent?
The patent is estimated to expire on July 6, 2038.
How does this formulation enhance ultrasound imaging?
The formulation enhances ultrasound imaging by providing gas-filled microvesicles that improve the visibility of blood vessels and liver lesions.
What are the specific components of the formulation?
The formulation includes a phospholipid and a polyethylene glycol with a specific percentage of folded polymeric chains.
Sources
- DrugBank: Sulfur hexafluoride: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Lumason Availability.
- SLWIP: Patent Analytics.
- DrugBank: 1,2-Distearoyllecithin: Uses, Interactions, Mechanism of Action.
- Gale: Patent Issued for Freeze-Dried Formulation For Gas-Filled Microvesicles (USPTO 10,232,061).
