EP-4739221-A1 - MEDICAL BRUSHES WITH MULTIPLE DEGREES OF FREEDOM

Abstract

A cytology brush includes a shaft including a fluid lumen configured for passage of a fluid; a brush body including: a fixed element; and a moveable element with a radial outward surface and a plurality of bristles, wherein the bristles protrude externally from the radial outward surface. The moveable element is configured to receive the fluid through the fluid lumen to expand from an unexpanded configuration to an expanded configuration and in the unexpanded configuration of the moveable element, the bristles are in a retracted configuration and in the expanded configuration the bristles are in a deployed configuration.

Inventors

• SHARMA, DEEPAK KUMAR
• G, Sharath Kumar
• SMITH, PAUL
• BRECHBIEL, Scott

Assignees

• Boston Scientific Medical Device Limited
• Boston Scientific Scimed, Inc.

Dates

Publication Date

20260513

Application Date

20240729

Claims (1)

1. Attorney Docket No.: 06530-1320-00304 Client Ref. No.23-0264WO01 We claim: 1. A cytology brush comprising: a shaft including a fluid lumen configured for passage of a fluid; a brush body comprising: a fixed element; and a moveable element with a radial outward surface and a plurality of bristles, wherein the bristles protrude externally from the radial outward surface; wherein the moveable element is configured to receive the fluid through the fluid lumen to expand from an unexpanded configuration to an expanded configuration and in the unexpanded configuration of the moveable element, the bristles are in a retracted configuration and in the expanded configuration the bristles are in a deployed configuration. 2. The cytology brush of claim 1, wherein the moveable element is a balloon that is divided into a plurality of balloon sections, each balloon section including one or more bristles on an external surface of the balloon section. 3. The cytology brush of any of claims 1-2, wherein the moveable element includes three balloon sections: a distal balloon section, a middle balloon section, and a proximal balloon section and the bristles on the middle balloon section have a lowest stiffness. 4. The cytology brush of any of claims 1-3, wherein the bristles in the middle balloon section extend the greatest distance from a central axis of the cytology brush. 5. The cytology brush of any of claims 1-2, wherein the balloon is divided into three sections: a proximal balloon section, a middle balloon section, and a distal balloon section, each section comprising a distal sidewall and a proximal sidewall. Attorney Docket No.: 06530-1320-00304 Client Ref. No.23-0264WO01 6. The cytology brush of any of claims 1-5, wherein an outer wall of one or more of the balloon sections has a different hardness than an outer wall of other balloon sections. 7. The cytology brush of any of claims 1-6, wherein the one or more balloon sections with a lowest hardness rating expands furthest from a central axis of the shaft. 8. The cytology brush of any of claims 1-7, wherein each of the balloon sections includes a distal sidewall and a proximal sidewall and, when the balloon section is in the unexpanded configuration, a subset of bristles extend proximally from the distal sidewall and another subset of bristles extend distally from the proximal sidewall. 9. The cytology brush of any of claims 1-8, wherein the fluid is air, and wherein the air is delivered by a syringe operatively connected to the fluid lumen. 10. The cytology brush of any of claims 1-9, including four fluid lumen equally spaced about a circumference of the shaft to deliver fluid to respective portions of the brush. 11. The cytology brush of any of claims 1-10, wherein, when the bristles are in the deployed configuration, a central axis of each of the bristles is perpendicular to a central axis of the shaft. 12. The cytology brush of any of claims 1-2, wherein the balloon is biased toward a collapsed configuration. 13. The cytology brush of claim 2, the fixed element further comprising: a distal end wall; a proximal end wall, the distal end wall and the proximal end wall spaced apart longitudinally and connected by a plurality of longitudinal sidewalls extending between the distal end wall and the proximal end wall, wherein the balloon forms an air tight seal between each of the distal sidewalls, the proximal sidewall, and the longitudinal sidewalls forming one or more chambers for receiving fluid to expand and collapse the balloon between the expanded Attorney Docket No.: 06530-1320-00304 Client Ref. No.23-0264WO01 configuration and the unexpanded configuration such that the bristles move between the deployed configuration and a retracted configuration. 14. The cytology brush of claim 13, wherein the bristles form four columns of pairs of bristles in a longitudinal direction of the brush and overlap in the undeployed configuration. 15. The cytology brush of claim 13, wherein the balloon is caused to move between the expanded configuration and the unexpanded configuration by fluid pressure.

Description

Attorney Docket No.: 06530-1320-00304 MEDICAL BRUSHES WITH MULTIPLE DEGREES OF FREEDOM AND RELATED METHODS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No.63/517,001, filed on August 1, 2023, which is incorporated by reference herein in its entirety. TECHNICAL FIELD [0002] Aspects of this disclosure generally relate to medical brushes with multiple degrees of freedom and related methods. In particular, aspects of this disclosure relate to cytology brushes having brushes with multiple degrees of freedom and methods related to using such cytology brushes. BACKGROUND [0003] Analyzing cell samples can be a helpful tool in the diagnosis and treatment of disease. Undiagnosed pain, unusual symptoms, unusual or abnormal samples, or other factors can require further investigation, and such investigation often necessitates using advanced medical devices. Medical devices, such as cytology brushes or other suitable devices, may be employed for a variety of diagnostic and surgical procedures. Many of these procedures involve delivering the cytology brush to an internal stricture (e.g., a biliary stricture) using a wire guided catheter. Diagnosis procedures often involve the removal of a portion of suspected cancerous tissue by collecting a sample of a mucosal tissue layer off the surface of a lumen within the biliary track. Diagnosing biliary strictures, done typically with cytology brushes, can be difficult because of a low cancer sensitivity rate, which can produce a false-negative diagnosis during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. Low sensitivity is frequently linked to inadequate tissue sampling, which can be a limiting factor in the detection of potential malignancy. [0004] Diagnosis procedures can involve removal of suspected cancer by collection of a sampling of a mucosal tissue layer off the surface of a lumen within the biliary track. Although current brushes may have a degree of freedom of movement (i.e., distally in and proximally out of a patient’s body, as guided along a guidewire), the brush may not be capable of entering or crossing a stricture. For example, a tip or distal end of a brush includes radially or outwardly extending ^ Attorney Docket No.: 06530-1320-00304 Client Ref. No.23-0264WO01 bristles, and the bristles may redirect or otherwise impede the delivery or movement of brush (e.g., when entering a stricture). In some cases, for example, brush movement may terminate in a dilated region or pocket in front of a stricture. Brushes with additional degrees of freedom of movement, for example, with an ability to expand/collapse, may provide additional functionality with respect to passing a stricture or otherwise collecting a sample. [0005] The devices and methods of this disclosure may rectify one or more of the deficiencies described above or address other aspects of the art. It is to be noted, however, that the scope of subject matter of this application is defined by the features listed in the claims, and not an ability to rectify any particular deficiency. SUMMARY [0006] Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects. [0007] Aspects of the disclosure relate to, among other things, systems, devices, and methods for recovering a sample from a subject. Aspects of this relate to, among other things, medical brushes with multiple degrees of freedom and related methods. [0008] In some aspects, a cytology brush may include a shaft including a fluid lumen configured for passage of a fluid, and a brush body. The brush body may include a fixed element, and a moveable element with a radial outward surface and a plurality of bristles. The bristles may protrude externally from the radial outward surface. The moveable element can be configured to receive the fluid through the fluid lumen to expand from an unexpanded configuration to an expanded configuration. In the unexpanded configuration of the moveable element, the bristles may be in a retracted configuration, and, in the expanded configuration, the bristles may be in a deployed configuration. [0009] The cytology brush may include one or more of the following aspects. The moveable element may be a balloon that is divided into a plurality of balloon sections. Each balloon section may include one or more bristles on an external surface of the balloon section. The moveable element may include three balloon sections: a distal balloon section, a middle balloon section, and a proximal balloon section. The bristles on the middle balloon section may have a lowest stiffness. The bristles in the middle balloon section may extend the greatest distance from a central axis of the cytology brush. The balloon may be divided into three sections: a Attorney Docket No.: 06530-1320-00304 Client Ref. No.23-0264WO01 proximal balloon section, a middle balloon section