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 • Loma Linda University
Publication Number
US-10932816-B2
Publication Date
2021-03-02
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 relates to a needle access assembly and corresponding method for obtaining percutaneous needle access with little or no use of fluoroscopy. The method involves selecting a target site, directing a laser guide at a desired needle-insertion angle in line with the selected target, aligning the needle access assembly with the laser, and inserting the needle into the intended anatomical target. This enables procedures that traditionally require real-time imaging guidance, particularly fluoroscopy, to be performed with minimal or no exposure to ionizing radiation.
A key problem addressed by the invention is the significant radiation exposure to both patients and medical staff resulting from prolonged fluoroscopy during percutaneous access procedures. Conventional techniques require continuous fluoroscopic monitoring to guide the insertion of a needle into deep anatomical structures, such as the renal calices, making precise needle placement difficult and contributing to cumulative occupational and patient radiation risk. The difficulty is compounded by the need for high positional accuracy and the movement of internal organs.
The core innovation provides a device and method that use a laser or other light-guided system, optionally combined with visual indicators on the needle assembly, to facilitate accurate needle placement. The needle access device features a hub with an opaque cap and a non-opaque body portion; the design ensures the body only illuminates when aligned correctly with the light source. This visual confirmation improves targeting accuracy and enables a reduction or elimination of fluoroscopic exposure during percutaneous access.
Claims Coverage
There are two primary independent inventive features covered by the claims.
Needle access device with opaque cap, non-opaque body, and channel for selective light transmission
The device comprises: - A needle connected to a hub portion that has an opaque cap portion featuring a non-opaque patterned portion (such as at least two concentric circles) to facilitate light positioning through a channel. - A non-opaque body portion positioned between the opaque cap and the needle. - The channel extends through the opaque cap, and is positioned such that the non-opaque body only illuminates when the light source is correctly aligned with the channel. This structure provides visual feedback for proper alignment during needle insertion.
Needle access device with non-opaque crosshatch patterned portion
The device includes: - A needle connected to a hub portion with an opaque cap portion having a non-opaque crosshatch patterned portion to facilitate positioning of light through a channel. - A non-opaque body portion positioned between the opaque cap and the needle. - The channel extends through the cap such that the non-opaque body only illuminates when the light source is aligned with the channel. This inventive feature provides visual indication when the device is properly aligned with the insertion trajectory.
The inventive features focus on a needle access device that provides direct visual alignment feedback through selective illumination of the hub, using patterned, opaque, and non-opaque portions, significantly aiding precision in percutaneous access with reduced reliance on fluoroscopy.
Stated Advantages
Significantly reduces radiation exposure to both patients and surgical staff compared to conventional fluoroscopy-guided techniques.
Enables accurate and precise placement of the needle during percutaneous access procedures with little or no use of fluoroscopy.
Provides visual confirmation of alignment for the user, improving procedural reliability and ease of use.
Allows incremental reduction in radiation exposure by 5-10% or up to between 5% and 99%, depending on procedural choices.
Documented Applications
Placement of a needle into the kidney for access to the renal calices, as in procedures for stone surgery.
Placing probes into the kidney to treat renal cancer.
Accessing infected fluid collections for abscess drainage.
Placing tubes into various body spaces to serve as drains, including pleural space, peritoneal drain, cholecystectomy drain, bladder drain, lymphocele drain, and pericardial space.
Used in training models designed to simulate percutaneous access procedures for educational purposes.
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