Methods and apparatuses for fluoro-less or near fluoro-less percutaneous surgery access
Inventors
Baldwin, Dalton Duane • Yeo, Alexander • Martin, Jacob
Assignees
FACULTY PHYSICIANS AND SURGEONS OF LOMA LINDA UNIVERSITY SCHOOL OF MEDICINE • Faculty Physicians And Surgeons Of Loma Linda University • Loma Linda University
Publication Number
US-10085767-B2
Publication Date
2018-10-02
Expiration Date
2034-06-03
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Abstract
A needle access assembly and method for obtaining percutaneous needle access with little or no fluoroscopy. The method can include selecting a target for percutaneous access, directing a laser guide at a desired needle-insertion angle and in line with the selected target, aligning the needle access assembly with the laser, and inserting the needle into the target.
Core Innovation
The invention provides a needle access assembly and method for obtaining percutaneous needle access with little or no fluoroscopy. The device includes a needle connected to a hub portion, where the hub has an opaque cap portion, a non-opaque body portion positioned between the opaque cap portion and the needle, and a channel through the cap. The non-opaque portion only illuminates when a light source, such as a laser, is precisely aligned with the channel, providing visual confirmation of alignment to the user. This system allows the user to align the needle accurately with a chosen target by using the visual indicator created by the hub illumination.
The background describes percutaneous access as a common but difficult step in various medical procedures, often requiring real-time imaging such as ultrasound, CT, or fluoroscopy for accurate needle placement. Conventional fluoroscopy-guided procedures expose patients and staff to significant radiation risks, including cancer and tissue damage. Therefore, there is a need for a device and method that enable precise and accurate percutaneous needle placement while reducing or eliminating dependence on fluoroscopy or other ionizing imaging methods.
The proposed method involves selecting a target for percutaneous access, directing a laser guide or other light source at the desired insertion angle, and aligning the needle device with the light. The needle is then inserted into the selected target, with confirmation of proper trajectory provided by hub illumination. Additional instruments such as balloon or basket catheters identifiable under ultrasound can be used to further facilitate access. The process allows for reduced or minimal use of fluoroscopy, and may be adapted to various imaging modalities.
Claims Coverage
The patent claims coverage centers around a single independent claim, focusing on features that enable reduced fluoroscopy during percutaneous needle access.
Needle access device with illumination-only-on-precise-alignment
A needle access device is described, comprising: - A needle connected to a hub portion. - The hub includes an opaque cap portion. - A non-opaque body portion positioned between the opaque cap and the needle. - A channel extending through the opaque cap, arranged so that the non-opaque body only illuminates when a light source (such as a laser) is aligned precisely with the channel. - A reflective surface (specifically, a dome reflector) positioned in the non-opaque body portion, enhancing the illumination effect upon correct alignment. This configuration ensures visual feedback for correct trajectory by making the hub illuminate only when both angle and alignment with the light source are correct.
These inventive features provide a visually guided percutaneous needle access device that enables precision alignment and insertion with reduced or minimal reliance on fluoroscopy.
Stated Advantages
Reduces radiation exposure to the patient, surgeon, and operating room staff by minimizing or eliminating the use of fluoroscopy during percutaneous access.
Enables accurate and precise needle placement into selected targets with visual confirmation of alignment, thereby reducing the difficulty and risk associated with conventional imaging-guided access.
Simplifies percutaneous access procedures by providing easily interpreted visual feedback to users, supporting precision without continuous imaging.
Allows incremental reduction of radiation exposure, with potential reductions ranging from 5% to 99% per procedure.
Documented Applications
Obtaining percutaneous access to the kidney for procedures such as stone surgery, including placement of a needle into the calyx for access to the collecting system.
Placement of probes into the kidney to treat renal cancer, accessing infected fluid collections for abscess drainage, and inserting tubes for drainage in spaces such as the pleural space, peritoneal cavity, cholecystectomy site, bladder, lymphocele, or pericardial space.
Training users in percutaneous access procedures using a simulation model replicating human tissue layers and collecting systems, as described in the training model.
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