Method and apparatus for coaptive ultrasound gastrostomy
Inventors
Assignees
University of Maryland Baltimore
Publication Number
US-12161363-B2
Publication Date
2024-12-10
Expiration Date
2037-04-05
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Abstract
Disclosed is a system and method for the placement of elongate medical members within a patients body using coaptive ultrasound. In a particularly preferred embodiment, a flexible tube includes a first balloon at a distal end of the tube, and a second balloon at the distal end of the tube and positioned within the first balloon. The first and second balloons are inflatable to form one or more echogenic windows between them, which echogenic window may be detected from within a patient's body by an ultrasound probe that is external to the patient's body. Detection of such echogenic window is used to identify an acceptable location on the patient's body at which to insert a guidewire configured to receive an elongate medical member without damage to surrounding patient tissues or organs.
Core Innovation
The invention disclosed is a system and method for the placement of elongate medical members, such as catheters or gastrostomy tubes, within a patient's body using coaptive ultrasound. In a preferred embodiment, a flexible tube is equipped at its distal end with two balloons: an inner balloon and an outer balloon, with the inner balloon situated inside the outer balloon. Both balloons can be inflated to create one or more echogenic windows between them. These echogenic windows are detectable by an external ultrasound probe, providing real-time visualization inside the patient's body.
This ultrasound-guided visualization allows precise identification of a safe location for inserting a guidewire and, subsequently, an elongate medical member, without damaging surrounding tissues or organs. The system is intended to work with common and accessible devices such as ultrasounds, feeding tubes, guidewires, and dilators, making the placement process less dependent on specialized equipment like endoscopes or CT scanners. The echogenic window, created between the inflatable members, significantly reduces the risk of inadvertent injury during insertion by clearly marking the cannulation tract.
The method and apparatus are particularly suitable for bedside procedures, enabling acute care physicians and non-specialist healthcare providers to safely and reliably perform operations that previously required specialized training and equipment. The device design allows for variations including the use of spacers, such as rivets or ridges, to maintain the integrity of the echogenic window and incorporates features such as single or double balloon configurations, optional snare releases, and anchoring mechanisms for guidewires.
Claims Coverage
The patent includes two independent claims, each defining inventive features relating to ultrasound-guided placement of medical devices using inflatable members and echogenic visualization.
Ultrasound-guided method using coaxial inflatable members with echogenic fluid
A method comprising: - Introducing a distal end of an elongated member into a patient cavity to position both a first inflatable member and a second inflatable member (the second being inside the first) within the cavity. - Delivering echogenic fluid through a first lumen of the elongated member into the space between the inner surface of the first inflatable member and the outer surface of the second inflatable member, expanding the first inflatable member and creating an echogenic interior volume. - Delivering an inflation fluid through a second, fluidically isolated lumen into the second inflatable member to expand it. - Visualizing the echogenic interior volume using an ultrasound probe placed on the opposite side of a tissue plane from the cavity. Additional dependent features include advancing a guidewire through the tissue plane and inflatable members, contracting the inflatable members for guidewire manipulation, use of spacers between inflatable members (including ridges), and delivering multiple fluids or using multiple cavities for echogenic fluid placement.
Method using inflatable members with spacers for echogenic window formation and ultrasound visualization
A method comprising: - Translating a distal end of an elongated member into a patient cavity such that a first and a second inflatable member, with the second inside the first, are both positioned within the cavity. - Providing multiple spacers, each being a rivet, between the inner surface of the first inflatable member and the outer surface of the second inflatable member. - Expanding both inflatable members to create an echogenic interior volume between them. - Visualizing the echogenic interior volume within the cavity using an ultrasound probe placed on the opposite side of a tissue plane.
In summary, the inventive features center on the use of coaxial inflatable members and echogenic fluid to provide real-time ultrasound visualization for safe and accurate placement of medical members, supported by spacers to maintain the echogenic window.
Stated Advantages
Enables safe and reliable placement of catheters and elongate medical members without the need for expensive, specialized equipment, such as endoscopes, fluoroscopes, and CT scanners.
Allows acute care physicians and other healthcare providers trained in ultrasound, rather than requiring specialist consultants, to perform gastrostomy and similar procedures at the bedside.
Provides real-time visual confirmation with ultrasound to ensure no bowel, organs, or blood vessels obstruct the insertion tract, reducing risks of injury during device placement.
Permits faster, more immediate, and more cost-effective care by eliminating the need for specialist involvement, patient transportation, and hospital admission in many cases.
Reduces overall costs, patient stress, risk of nosocomial infection, and unnecessary hospital admissions related to gastrostomy tube management.
Documented Applications
Placement of gastrostomy tubes for direct nutritional supplementation into the stomach of patients unable to eat orally.
Placement of catheters, conduits, or other elongate medical members in various tissue planes and cavities, such as the thorax, abdomen, blood vessels, and pericardium, for diagnostic, therapeutic, and procedural purposes.
Re-insertion of dislodged gastrostomy tubes at the bedside by emergency medicine physicians or intensivists, enabling immediate patient discharge.
Use in nursing homes and rehabilitation facilities by geriatricians and rehabilitation physicians for placing feeding tubes or similar medical devices with ultrasound guidance.
Positioning suction tubes within the body for removal of unwanted fluid.
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