JP-7857027-B2 - Biopsy/cytology devices for sampling mammalian cells or tissues

Inventors

• ニクラス ロックスヘッド
• フィリペ マルケス
• ウーター メッツォラ ファン デル ワインガルト
• フランシスコ バルダック シウヴァ
• アーバン アルネロ

Assignees

• ラッキー ループ メディカル アーべー

Dates

Publication Date

20260512

Application Date

20211221

Priority Date

20201225

Claims (12)

1. A device for performing fine-needle aspiration, FNA, or fine-needle biopsy, FNB , Hollow needle and A slender member is movably disposed inside the lumen of the needle , The slender member comprises at least one flexible member disposed at the distal end of the slender member, The flexible member has a first restraining configuration within the lumen of the needle, and following the advance of the elongated member in the needle, the flexible member has a second expanding configuration outside the lumen, and when the flexible member is in the second expanding configuration, it is arranged to form at least one loop . The device further comprises a tubular sheath disposed on the outside of the elongated member, the tubular sheath configured to contact, on the outside of the lumen, a loop that moves along the elongated member and expands inside the lumen of the needle. device.
2. The device according to claim 1, wherein the flexible member is a superelastic wire made of a shape memory alloy.
3. The device according to claim 1 or 2 , wherein the loop is substantially circular in the second extended configuration .
4. The device according to any one of claims 1 to 3, wherein at least a portion of the flexible member has a substantially helical shape, and the axis of the helix is substantially parallel to the overall extending direction of the flexible member.
5. The device according to any one of claims 1 to 4, wherein at least a portion of the flexible member has a sawtooth structure.
6. The device according to claim 5, wherein the sawtooth structure is a microstructure on the surface of the flexible member.
7. The device according to any one of claims 1 to 6, wherein the elongated member and the flexible member are integrally formed as a monolithic structure, and the diameter of the flexible member is smaller than the diameter of the elongated member.
8. The device according to any one of claims 1 to 6, wherein the elongated member comprises a mounting interface provided at its distal end, and the at least one flexible member is attached to the elongated member via the mounting interface.
9. The device according to claim 8, wherein the mounting interface includes at least one hole for fastening the at least one flexible member to the elongated member, a mechanical interlocking mechanism between the elongated member and the at least one flexible member, a weld line, an adhesive line, or a combination thereof.
10. The device according to claim 8 or 9, wherein the mounting interface is covered with heat-shrink tubing.
11. The device according to any one of claims 1 to 10 , wherein the tubular sheath is made from a polymer such as polyether, polyamide, polyimide, or polytetrafluoroethylene, PTFE, or a metal such as nickel-titanium or stainless steel.
12. The device according to any one of claims 1 to 11 , wherein the elongated member and/or the flexible member are surface-treated or coated to reduce the coefficient of friction.

Description

This disclosure generally relates to a device for separating cells within a subject's cavity, and to liquid biopsy/cytology for sampling cells or tissue from the subject's cavity. The biopsy/cytology method includes introducing and manipulating the device through a hollow catheter or needle to enable obtaining a cell sample. Pancreatic cancer is currently the fourth leading cause of cancer-related death in the West, and its prevalence is estimated to become the second highest among all cancers by 2030. The prognosis remains very poor, and because the disease is often advanced by the time of diagnosis, the five-year survival rate is only 2% to 9%, the lowest among all cancers. Pancreatic cystic lesions are precursors to most pancreatic cancers, and their prevalence in the general population is as high as 40%. Therefore, it is crucial to properly diagnose whether pancreatic cysts are potentially benign or malignant. Ultrasonic endoscopy (EUS)-guided fine-needle aspiration (FNA) and subsequent fluid cell analysis are used as diagnostic tools to differentiate between benign, potentially malignant, and malignant pancreatic cysts in cystic lesions. While EUS-FNA yields promising results for solid lesions, it is poor for cystic lesions due to the sparse cellular content in the cystic fluid. The reason for the lack of cells in the cystic fluid is that EUS-FNA removes the cystic fluid content, not the cystic lining or wall, which are normally covered by cells. As a result, the sensitivity of this method ranges from 65% to 95%, and the specificity from 50% to 100%. The average precision is 85%, meaning that in 20% of cases, inconclusive or ambiguous situations arise. This lack of information can prevent cytopathologists from making a diagnosis. To address this issue, a surgical "through-the-needle" cytology brush (EchoBrush, Cook Endoscopy, Winston-Salem, North Carolina) using a 19G needle was developed, yielding diagnostic data in 85.1% of cases. However, due to an increased risk of bleeding, production of these devices was discontinued. International Publication No. 2018/053402 discloses a pancreatic cyst device deployable within a cyst via a 22-gauge endoscopic ultrasound (EUS) needle. This device features a flexible shaft with a "spiral Q" shaped distal end designed to maximize contact area along the cyst's contour and a proximal end connectable to a handle, allowing the operator to rotate the device within the pancreatic cyst to remove cells from the cyst lining. However, the aforementioned devices still carry the risk of damaging the cyst lining, and the spiral-shaped distal end can break during operation and retract into the outer shaft. Furthermore, the flexible shaft is made from nitinol along its entire length, making it costly to manufacture. Therefore, it is necessary to improve known devices and methods to address the aforementioned shortcomings. Next, the present invention will be described for illustrative purposes with reference to the accompanying drawings. This figure shows an endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) pathway toward a cyst in the pancreas, different steps for operating the device, and the device in conjunction with EUS-FNA outside the human body, as used by a device according to one embodiment of the present disclosure. The figure shows a photograph of a device according to one embodiment of the present disclosure with a 22G needle, and scanning electron microscope (SEM) images of the mounting interface in the form of a knot before and after the placement of the heat shrink tubing. The diagram shows a cross-sectional view of the operation of the device according to one embodiment of the present disclosure in the cavity of a cyst phantom, a side view photograph of the cyst phantom with the device inserted, axial views of the anterior and posterior portions of the cyst phantom before and after brushing with the device, and the differences between them. This figure shows a schematic diagram of an ex vivo test of a device according to one embodiment of the present disclosure in a porcine small intestine model. Figure 4 shows the absolute cell concentration and brush efficiency from the tests conducted. Figure 4 shows the absolute cell concentration and brush efficiency from the tests conducted. This figure shows a schematic diagram of an ex-vivo test of the device according to one embodiment of the present disclosure in bovine follicular cysts, as well as cell counter images with and without brushing. This figure shows four embodiments of a flexible member disposed at the distal end of an elongated member according to the present disclosure. This figure shows an enlarged view of a flexible member according to a different embodiment of the present disclosure. This figure shows different steps for operating a device according to another embodiment of the present disclosure. The following provides a detailed description of the device described herein. In the drawings, s