Device for biological cell collection and method of use
Inventors
Chak, Amitabh • Markowitz, Sanford • Siedlak, Dennis • Willis, Joseph • Aklog, Lishan • BOUTILLETTE, Michael • Yazbeck, Richard
Assignees
Case Western Reserve University • Lucid Diagnostics Inc
Publication Number
US-12262879-B2
Publication Date
2025-04-01
Expiration Date
2040-06-16
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Abstract
A device for collecting a biological sample in a subject, the device including an inflatable portion attached to a tubular member, and designed to expand from within the tubular member when inflated and to retract within the tubular member, a surface on the inflatable portion provided with varied thickness to facilitate movement of the inflatable portion between an expanded state and a retracted state, and a plurality of projections on the surface to allow collection of the biological sample when the inflatable portion is in the expanded state.
Core Innovation
The invention provides a device for collecting biological samples from a subject by using a specialized collection mechanism. This device incorporates an inflatable portion attached to a tubular member. When inflated, the inflatable portion expands from within the tubular member, and when deflated, it retracts back inside. The surface of the inflatable portion features varied thickness, which aids in smooth transition between expanded and retracted states, and contains a plurality of projections to collect biological samples such as tissue, cells, protein, RNA, or DNA, particularly from locations like the esophagus.
The problem addressed is the limitation of known tissue collection devices, which utilize expandable devices with longitudinal folds to trap tissue during deflation. The existing methods may present challenges in reliable retraction, avoidance of sample contamination, and versatility for different sample types. The present invention seeks to improve the reliability, efficiency, and ease of cell and tissue collection through new structural designs.
The device introduces features such as variable wall thickness using different durometer levels, collapsible folds, circumferential ridges, and structured projections (including V-shaped bristles) to facilitate inflation, sample collection, deflation, and retraction. These projections enhance the collection efficiency when the device is expanded and help retain the sample when it is retracted. Removability, mechanical and friction fits, and adjustable configurations further enhance usability and facilitate cleaning and reuse of the device.
Claims Coverage
The patent claims coverage centers on a single independent claim with several main inventive features related to the configuration, structural variations, and functionality of the biological sample collection device.
Collection mechanism with inflatable distal portion and varied durometer levels
The device contains a tubular member for fluid direction and a collection mechanism attached at its distal end, with a proximal portion and a distal inflatable portion. The wall of the distal inflatable portion is provided with different durometer levels along its length, having a lower durometer than the proximal portion, to facilitate controlled extension, expansion, and retraction.
Varied thickness via circumferential geometric features
The collection mechanism's wall exhibits varied thickness due to a plurality of circumferential geometric features (such as folds or ridges) radially extending from the surface. These features aid in inflation, expansion, deflation, and retraction of the inflatable portion, enabling effective sample collection and structural transition.
Plurality of projections for sample collection
A plurality of projections is located on the surface of the inflatable portion's wall. These projections are configured to allow the collection of the biological sample when the inflatable portion is expanded.
Weight connected to proximal portion to aid swallowing
A weight is attached to the proximal portion of the collection mechanism, facilitating the swallowing of the device and advancement to the sample collection site within the body.
The main inventive features pertain to a device structure that combines a variable-durometer inflatable portion, circumferential geometric features for varied thickness, a pattern of sample-collecting projections, and a swallowing-assist weight, all integrated to optimize biological sample collection in a subject.
Stated Advantages
The device improves reliability and consistency of inflation, expansion, deflation, and retraction for biological sample collection in a subject.
Varied wall thickness and different durometer levels facilitate easier movement between expanded and retracted states and reduce the risk of sample contamination.
Plurality of projections and potential ridge designs increase the efficiency and quantity of biological sample collection.
Removable and replaceable collection mechanisms enable reuse of key device components and facilitate cleaning.
A weight facilitates ease of swallowing the device for simple deployment to the collection site.
Documented Applications
Collecting biological samples such as tissue, cells, protein, RNA, and/or DNA from a subject's esophagus.
Use in sampling from a human patient or animal subject for analysis relevant to diagnoses, such as identification of abnormal columnar epithelial cells indicative of Barrett's Esophagus.
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