US-12622684-B1 - Punch biopsy tool with transverse cutter and angular adjustment

US12622684B1US 12622684 B1US12622684 B1US 12622684B1US-12622684-B1

Abstract

A punch biopsy tool includes an upper housing, lower housing, and a circular cutter attached to the lower housing configured to make a circular incision around a target tissue. A transverse cutter performs removal of the target tissue sample. An axially movable upper shaft member within the upper housing pivotally attaches to an intermediate linkage member. A lower linkage member is pivotally connected to an end of the intermediate linkage member. The transverse cutter may be formed by a pair of blades connected to the lower linkage member. Means for adjusting an angular orientation of the upper housing relative to the lower housing may be included such as an accordion shaped material or pivotable joint. Alternatively, the upper housing may be formed at a predetermined angle relative to the lower housing. The punch biopsy tool is suited for obtaining hard to reach tissue samples including, but limited to, oral lesions.

Inventors

Abdullah Mohamed Alsoghier
Nasser Raqe Alqhtani
Ali Saleh Al Rafedah

Assignees

KING SAUD UNIVERSITY

Dates

Publication Date: 20260512
Application Date: 20250218

Claims (19)

1 . A punch biopsy tool comprising: an upper housing; an intermediate housing; a lower housing, wherein the upper housing, the intermediate housing and the lower housing together form an outer housing; a circular cutter attached to the lower housing, wherein the circular cutter is configured to make a circular cut; a transverse cutter pivotally attached within the lower housing and the circular cutter and configured to make a transverse cut spanning a diameter of the circular cutter; mechanical means for actuating the transverse cutter; and means for adjusting an angular orientation of the upper housing relative to the lower housing.
2 . The punch biopsy tool according to claim 1 , wherein the transverse cutter includes a pair of blades pivotally mounted within the lower housing.
3 . The punch biopsy tool according to claim 1 , wherein the means for adjusting angular orientation of the upper housing relative to the lower housing includes a flexible material having an accordion shape forming the intermediate housing, wherein the accordion shape includes peaks, valleys, and annular ribs formed by the peaks and valleys.
4 . The punch biopsy tool according to claim 1 , further comprising an upper shaft member axially movable within the upper housing and an intermediate linkage member having an upper end pivotally connected to a lower end of the upper shaft member, wherein the intermediate linkage member is positioned within the outer housing.
5 . The punch biopsy tool according to claim 4 , further comprising a lower linkage member having an upper end pivotally connected to a lower end of the intermediate linkage member, wherein the lower linkage member is positioned within the outer housing.
6 . The punch biopsy tool according to claim 5 , wherein the transverse cutter is formed by a pair of blades connected to the lower linkage member and pivotally connected to the lower housing.
7 . The punch biopsy tool according to claim 6 , further comprising a spiral-shaped tissue gripping attachment mounted within the lower housing.
8 . The punch biopsy tool according to claim 7 , wherein the means for adjusting an angular orientation of the upper housing relative to the lower housing is a flexible accordion shape material including peaks defining an outermost diameter, valleys defining an inner diameter, and annular ribs formed by the peaks and valleys.
9 . The punch biopsy tool according to claim 3 , wherein the flexible material having an accordion shape is formed from a material selected from the group consisting of a polymer, an elastomer, or an elastomeric material.
10 . The punch biopsy tool according to claim 7 , wherein the means for adjusting an angular orientation of the upper housing relative to the lower housing includes a pivotable joint including spherical joint connectors.
11 . A punch biopsy tool comprising: an upper housing; an intermediate housing; a lower housing, wherein the upper housing, the intermediate housing, and the lower housing form an outer housing; an upper shaft member axially movable within the upper housing; means for moving the upper shaft member axially within the upper housing; an intermediate linkage member having an upper end pivotally connected to a lower end of the upper shaft member; a lower linkage member having an upper end pivotally connected to a lower end of the intermediate linkage member, wherein the intermediate linkage member and the lower linkage member are positioned within the outer housing; a circular cutter attached to the lower housing, wherein the circular cutter is configured to make a circular cut; and a transverse cutter joined to the lower linkage member and pivotally connected to the lower housing within the circular cutter.
12 . The punch biopsy tool according to claim 11 , wherein a longitudinal axis of the upper housing is set at a predetermined slanted angle relative to a longitudinal axis of the lower housing.
13 . The punch biopsy tool of claim 11 , further comprising means for adjusting an angular orientation of the upper housing relative to the lower housing.
14 . The punch biopsy tool of claim 13 , wherein the means for adjusting an angular orientation of the upper housing relative to the lower housing includes a flexible accordion shaped material forming the intermediate housing, wherein the accordion shape includes peaks, valleys, and annular ribs formed by the peaks and valleys.
15 . The punch biopsy tool according to claim 11 , wherein the transverse cutter includes a pair of blades.
16 . The punch biopsy tool according to claim 11 , further comprising ergonomic gripping surfaces formed on the upper housing.
17 . The punch biopsy tool according to claim 11 , wherein the circular cutter includes graduations on an outer surface thereof.
18 . A punch biopsy tool comprising: an upper housing; an upper shaft member axially movable within the upper housing; a lower housing, wherein the upper housing and the lower housing form an outer housing; an intermediate linkage member having an upper end pivotally connected to a lower end of the upper shaft member; a lower linkage member having an upper end pivotally connected to a lower end of the intermediate linkage member, wherein the intermediate linkage member and the lower linkage member are positioned within the outer housing; a circular cutter attached to the lower housing, wherein the circular cutter is configured to make a circular cut; a transverse cutter pivotally attached within the lower housing and circular cutter; mechanical means for actuating the transverse cutter; and wherein the upper housing is positioned in a fixed predetermined slanted orientation relative to the lower housing.
19 . The punch biopsy tool according to claim 18 , wherein the transverse cutter is formed by a pair of blades.

Description

BACKGROUND Field The disclosure of the present patent application relates to a biopsy device, and particularly to a punch biopsy tool having a circular cutter and transverse cutter as well as embodiments for angular adjustment thereof. Description of Related Art Oral cancer is often preceded by precursor lesions (e.g. oral leukoplakia and erythroplakia) and oral conditions (e.g. oral lichen planus). Such disorders may be diagnosed clinically but would also need a histopathological examination conducted through reviewing the tissue obtained from the oral cavity lining under a microscope to: 1) confirm or exclude the diagnosis; and, 2) to exclude the presence of dysplastic features of the oral epithelium. The presence of dysplastic features reflects architectural and cellular changes of the epithelial layers and can be classified as mild, moderate and severe dysplasia with an average of 12% increased risk of cancer. Several non-invasive methods may be used to diagnose oral cancer and dysplastic changes, including using toluidine blue dye, oral brush biopsy, and saliva-based and light-based oral cancer detection technologies. However, surgical biopsy remains the gold standard for diagnosing various oral benign and malignant lesions. The biopsy procedure can include surgical removal of the whole lesion (excisional) or certain areas (incisional) that show altered clinical morphology compared to the non-affected areas. The procedure may be done by use of a surgical blade or punch biopsy instrument, which is presently limited by the lack of a horizontal cutting edge specifically for oral mucosa tissue. A two-step procedure is typically required for using surgical blades and punch biopsy instruments involving first cutting with a circular punch blade and second capturing the tissue. To capture the tissue, the sample is lifted with a forceps and cut free from the underlying tissue using surgical scissors or a scalpel. Such instruments as described lack the angulation desired for the oral cavity, with most such biopsy instruments designed for use in other areas of the body. An accurate histopathology assessment of biopsied lesions requires proper tissue sampling by choosing two adequate samples having the right size and depth, especially for varied clinical appearance. Acquiring samples of insufficient depth may not include the underlying stroma and, therefore, result in inappropriate histopathological assessment and clinical management, often requiring another procedure. The advantages of using an oral punch biopsy include a precise tissue collection and reduced chance of sampling errors through the inclusion of a foreign body, which can be inadequately interpreted as cellular atypia. Nevertheless, limitations for using a punch biopsy tool include a crushing/tearing force caused by sharp instruments used to release the punched tissue sample, such as tissue forceps and surgical blades, as well as lack of angulation among prior punch biopsy instruments. Thus, a punch biopsy tool with transverse cutting and angular adjustment solving the aforementioned problems is desired. SUMMARY In a non-limiting embodiment, a punch biopsy tool is provided including an upper housing, an intermediate housing, and a lower housing. A circular cutter is attached to the lower housing and configured to make a circular cut in tissue to be biopsied. A spiral shaped tissue grasper may be mounted within the circular cutter and lower housing for attaching to a target tissue area to be biopsied. Further provided is a transverse cutter for removal of the target tissue sample. The transverse cutter is attached to the lower housing and configured to make a transverse cut spanning a diameter of the circular cutter. A mechanical means such as for example, a button, are provided for actuating the transverse cutter. Means for adjusting an angular orientation of the upper housing relative to the lower housing are provided such as, for example, a flexible accordion shaped material, a flexible joint, or a pivoting joint forming the intermediate housing. In a further non-limiting embodiment, the transverse cutter may include a pair of blades pivotally mounted to the lower housing. An axially movable upper shaft member may be provided within the upper housing as well as an intermediate linkage member pivotally connected to an end of the upper shaft member. A lower linkage member may be provided pivotally connected to an end of the intermediate linkage member. The pair of blades forming the transverse cutter may be connected to the lower linkage member and pivotally connected to the lower housing. The punch biopsy tool may include ergonomic gripping surfaces formed in the upper housing, and the circular cutter may include graduations on an outer surface thereof. In another embodiment, a punch biopsy tool is provided including an upper housing and a lower housing. An upper shaft member is provided which is axially movable within the upper housing. Mechanical