tissue penetrator

Abstract

A biopsy assembly includes: a biopsy tube having a lumen; a tissue penetrator having a distal tip shaped to penetrate tissue, wherein the tissue penetrator is located within the lumen and includes: an elongated flexible body shaped and sized movable within the lumen; a retractable distal cut portion connected to the elongated flexible body and extending from the lumen in an expanded state, the retractable distal cut portion being configured to retract to a width less than an internal width of the lumen in the retracted state, wherein the retractable distal cut portion includes a distal sharp cutting edge configured to make a thin incision through the tissue, wherein in the expanded state, a maximum width of the retractable distal cut portion is greater than the internal width or an internal diameter of the lumen.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 046,711, filed July 1, 2020, the entire contents of which are incorporated herein by reference.

[0003] Technical Field and Background Technology

[0004] In some embodiments, the present invention relates to a tissue penetrator, and more specifically, but not exclusively, to a tissue penetrator of a biopsy device. Summary of the Invention

[0005] The following are some examples of embodiments of the present invention. A feature in one example can be combined with a feature in another example:

[0006] Example 1: A biopsy component, comprising:

[0007] A biopsy tube having a lumen;

[0008] A tissue penetrator having a distal tip shaped to penetrate tissue, wherein the tissue penetrator is located within the lumen and comprises:

[0009] A slender, flexible body whose shape and size can move within the cavity;

[0010] A retractable distal cutting portion is connected to the elongated flexible body and extends from the lumen in an expanded state, and the retractable distal cutting portion is configured to retract to a width, which in the retracted state is less than an internal width of the lumen, wherein the retractable distal cutting portion includes a distal sharp cutting edge configured to make a thin incision through the tissue, wherein in the expanded state, a maximum width of the retractable distal cutting portion is greater than the internal width or an internal diameter of the lumen.

[0011] Example 2: A biopsy assembly as described in Example 1, wherein the distal tip extends distally to the retractable distal cutting portion, and the distal tip is integrated with the elongated flexible body.

[0012] Example 3: A biopsy assembly as described in Example 1, wherein the distal tip is integrated with the retractable distal cutting portion.

[0013] Example 4: A biopsy assembly as described in any of the preceding examples, wherein the retractable distal cut is at least partially flexible.

[0014] Example 5: A biopsy assembly as described in any of the preceding examples, wherein the retractable distal cut is thin and the ratio of the thickness of the retractable distal cut to the maximum width or diameter of the retractable distal cut is greater than 1:8.

[0015] Example 6: A biopsy assembly as described in any of the preceding examples, wherein the thickness of the distal sharp cutting edge is less than 0.1 mm.

[0016] Example 7: A biopsy assembly as described in any of the preceding examples, wherein one surface of the tissue penetrator is at least partially angled or at least partially curved, wherein the tissue penetrator includes a distal sharp cutting edge facing the tissue.

[0017] Example 8: A biopsy assembly as described in Example 7, wherein the angle between the surface and the tissue is greater than 20 degrees.

[0018] Example 9: A biopsy assembly as described in any of the preceding examples, wherein the side surface of the tissue penetrator is curved.

[0019] Example 10: A biopsy assembly as described in any of the preceding examples, wherein, in the expanded state, a cross section of a circumference of the retractable distal cut portion is a continuous arc.

[0020] Example 11: A biopsy assembly as described in Example 10, wherein the arc is directed at an angle of at least 30 degrees.

[0021] Example 12: A biopsy assembly as described in Example 10 or 11, wherein the radius of curvature of the arc is in the range of 0.2 to 20 mm.

[0022] Example 13: A biopsy assembly as described in any of Examples 10 to 12, wherein in the expanded state, the length of the arc can reach 30 mm.

[0023] Example 14: A biopsy assembly as described in any of the preceding examples, wherein, in the expanded state, an angle greater than 20 degrees is formed between a surface of the retractable distal cut portion facing the biopsy tube and the biopsy tube.

[0024] Example 15: The biopsy component as described in any of the preceding examples further includes:

[0025] A coupler configured to reversibly couple the elongated, flexible body of the tissue penetrator to the biopsy tube.

[0026] Example 16: A biopsy assembly as described in Example 15, wherein the coupler is configured to axially fix the tissue penetrator in a position relative to the biopsy tube.

[0027] Example 17: A biopsy assembly as described in any of the preceding examples, wherein the retractable distal cut is formed of a single thin and flexible material layer configured to bend around the elongated flexible body to a width smaller than the internal width of the lumen.

[0028] Example 18: A biopsy assembly as described in any of Examples 1 to 17, wherein the retractable distal cut is formed of a thin, flexible material layer configured to be rolled up at least partially around the elongated flexible body to a width smaller than the internal width of the lumen.

[0029] Example 19: A biopsy assembly as described in any of the preceding examples, wherein a projection of the retractable distal cut is a triangle.

[0030] Example 20: A biopsy assembly as described in any of the preceding examples, wherein an outer surface of the retractable distal cut is smooth.

[0031] Example 21: A biopsy assembly as described in any of the preceding examples, wherein the retractable distal cutting portion is rigid in one axial direction and flexible in one lateral direction and / or all lateral direction.

[0032] Example 22: A biopsy assembly as described in any of the preceding examples, wherein a minimum thickness of a wall of the biopsy tube surrounding the lumen is at least 10% of the inner diameter of the biopsy tube.

[0033] Example 23: A biopsy assembly as described in any of the preceding examples, wherein a minimum thickness of one wall of the biopsy tube is 0.05 mm.

[0034] Example 24: A tissue penetration method, comprising:

[0035] A tissue penetrator having a retractable cutting section is advanced through a tissue wall located between a biopsy tube and a target tissue to be sampled.

[0036] A thin incision is formed through the retractable cutting section, passing through the tissue wall;

[0037] The retractable cutting section is retracted into one lumen of the biopsy tube.

[0038] Example 25: A tissue penetration method as described in Example 24, wherein the target tissue is sampled by moving the biopsy tube forward into the target tissue.

[0039] Example 26: A tissue penetration method as described in Example 25, wherein sampling the target tissue includes sampling the target tissue by rotating the biopsy tube while moving the biopsy tube forward into the target tissue.

[0040] Example 27: A tissue penetration method as described in any of Examples 24 to 26, wherein the thin incision is an incision with a thickness-to-length ratio greater than 1:10.

[0041] Example 28: A tissue penetration method as described in any of Examples 24 to 27, wherein forming the thin incision through the tissue wall comprises forming a thin straight incision through the retractable cutting portion within the tissue wall.

[0042] Example 29: The tissue penetration method as described in Example 28, wherein the tissue wall includes an intestinal tissue wall or a duodenal tissue wall.

[0043] Example 30: A tissue penetration method as described in any of Examples 24 to 27, wherein forming the thin incision through the tissue wall includes forming a thin, curved incision within the tissue wall.

[0044] Example 31: The tissue penetration method as described in Example 30, wherein the tissue wall includes a stomach wall.

[0045] Example 32: A tissue penetration method as described in Example 28 or 29, wherein the radius of curvature of the thin incision is in the range of 0.2 to 20 mm.

[0046] Example 33: A tissue penetration method as described in any of Examples 24 to 32, wherein retraction into the lumen of the biopsy tube includes retracting the tissue penetrator through the lumen.

[0047] Example 34: A tissue penetration method as described in any of Examples 24 to 33, wherein shrinking into the lumen of the biopsy tube includes at least partially rolling up the retractable cutting portion.

[0048] Example 35: A tissue penetration method as described in any of Examples 24 to 34, wherein shrinking into the lumen of the biopsy tube includes reversibly shrinking the shrinkable cutting portion.

[0049] Example 36: The tissue penetration method as described in any of Examples 24 to 35 further includes:

[0050] Before sampling the target tissue, the tissue penetrator is at least partially removed from the lumen.

[0051] Example 37: A tissue penetration method as described in any of Examples 24 to 36, wherein shrinking into the lumen of the biopsy tube includes inserting the shrinkable cut portion into the lumen without tissue sampling.

[0052] Example 38: A tissue penetration method as described in any of Examples 24 to 37, wherein the tissue wall includes a tracheal airway wall or a tracheal wall.

[0053] Example 39: A tissue penetration method as described in any of Examples 24 to 38, wherein the tissue wall includes a gastrointestinal wall and an esophageal wall.

[0054] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While similar or equivalent methods and materials described herein may be used to practice or test embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. Furthermore, materials, methods, and embodiments are illustrative only and are not necessarily limiting. Attached Figure Description

[0055] Some embodiments of the invention are described herein by way of example only with reference to the accompanying drawings. Reference will now be made in detail to the drawings, with emphasis placed on the details shown as examples and for the purpose of illustrative discussion of embodiments of the invention. In this regard, the description taken in conjunction with the drawings will enable those skilled in the art to clearly understand how embodiments of the invention can be practiced.

[0056] In the attached diagram:

[0057] Figure 1 This is a flowchart of a general process for penetrating and shrinking a tissue penetrator according to some exemplary embodiments of the present invention;

[0058] Figure 2A This is a state diagram scheme according to some exemplary embodiments of the present invention, which illustrates the change of a tissue penetrator between an expanded state and a contracted state;

[0059] Figure 2B and Figure 2C A schematic diagram of a straight incision (2B) and the penetration of a tube, for example, a biopsy tube passing through a straight incision (2C), according to some exemplary embodiments of the present invention;

[0060] Figure 2D This is a schematic diagram of some exemplary embodiments of the present invention, showing the penetration of a tube, such as a biopsy tube, through a curved incision (e.g., an arcuate incision);

[0061] Figure 3This is a flowchart of a general process according to some exemplary embodiments of the present invention for advancing a tissue penetrator through tissue and retracting and removing the tissue penetrator to allow, for example, tissue sampling.

[0062] Figure 4A and Figure 4B This is a block diagram of a tissue penetrator having a retractable cutting portion according to some exemplary embodiments of the present invention;

[0063] Figure 5A and Figure 5B This is a schematic diagram according to some exemplary embodiments of the present invention, which illustrates reversible coupling between a tissue penetrator and a biopsy tube;

[0064] Figures 6A to 6E This is a schematic diagram of some exemplary embodiments of the present invention, illustrating tissue penetration, retraction of the tissue penetrator, and tissue sampling;

[0065] Figures 7A to 7H This is a schematic diagram of different types of tissue penetrators with different retractable tissue penetration portions (e.g., cutting portions) according to some exemplary embodiments of the present invention;

[0066] Figures 8A to 8E This is a schematic diagram of a tissue penetrator according to some exemplary embodiments of the present invention, the tissue penetrator having an axis and a retractable tissue penetrating portion (e.g., a retractable cutting portion), the retractable tissue penetrating portion being connected to the axis in an expanded state;

[0067] Figure 9A and Figure 9B This is a schematic diagram according to some exemplary embodiments of the present invention, which illustrates a contracted state. Figures 8A to 8E The tissue penetrator;

[0068] Figure 10A and Figure 10B According to some exemplary embodiments of the present invention, in an expanded state ( Figure 10A A schematic cross-sectional view of a shrinkable tissue penetration portion in a contracted state, wherein the shrinkable cutting portion is bent into an arc within a sampling cannula;

[0069] Figure 10C and Figure 10D According to some exemplary embodiments of the present invention, in an expanded state ( Figure 10D A schematic cross-sectional view of a shrinkable tissue penetration portion (e.g., a shrinkable cutting portion) in a contracted state, wherein the shrinkable tissue penetration portion is rolled up (e.g., rolled up); and

[0070] Figure 11A and Figure 11BThis is a schematic diagram of some exemplary embodiments of the present invention, showing a tissue penetrator having an integrated shrinkable tissue penetrating portion (e.g., a shrinkable cutting portion). Detailed Implementation

[0071] In some embodiments, the present invention relates to a tissue penetrator, and more specifically, but not exclusively, to a tissue penetrator of a biopsy device.

[0072] One aspect of some embodiments involves retracting at least a portion of a tissue penetrator (e.g., a core needle) prior to a biopsy. In some embodiments, a cut portion of the tissue penetrator is retracted into a sampling tube, such as a sampling needle, prior to a biopsy. As used herein, a sampling tube refers to a biopsy tube, and a sampling needle refers to a biopsy needle. In some embodiments, the cut portion is retracted into an inner lumen of the sampling tube, for example to allow removal of the tissue penetrator from the body.

[0073] According to some embodiments, for example, the cutting portion retracts into the sampling tube when the sampling tube reaches a desired target tissue within the body for sampling. In some embodiments, the cutting portion retracts as the sampling tube approaches, for example at a distance of less than 2 mm, such as less than 1 mm, less than 0.5 mm, or any intermediate, smaller, or larger value from a desired target tissue. Alternatively, the cutting portion retracts partially when the sampling tube contacts a desired target tissue.

[0074] According to some embodiments, in an expanded state, the cut portion is wider than an opening of the sampling tube. In some embodiments, in a contracted state, the width of the cut portion is less than a minimum width of the sampling tube, such as a minimum inner diameter. In some embodiments, in an expanded state, the width of the cut portion is similar to or less than an outer diameter or maximum width of the sampling tube. In some embodiments, in an expanded state, the maximum width of the cut portion, such as a maximum distance between two points on the cut portion, is within a range between half the circumference of the sampling tube and the diameter of the sampling tube.

[0075] According to some embodiments, the cutting portion (e.g., a retractable cutting portion) is rigid in one axial direction, for example, to allow penetration of a tissue wall or membrane without retraction. Additionally, the cutting portion is flexible in one lateral and / or omnidirectional direction, for example, to allow bending into the tube (e.g., a biopsy tube). In some embodiments, the tissue wall includes the stomach wall, duodenal wall, intestinal wall, tracheal wall, bronchial airway wall, blood vessel wall, gastrointestinal tract wall, esophageal wall, epithelium, skin, diaphragm, pleura, heart wall, and / or cardiac diaphragm.

[0076] In some embodiments, in an expanded state, the cut is straight, for example when penetrating a tissue wall with low self-sealing properties (e.g., the intestinal or duodenal wall), thus forming a straight incision to minimize leakage through the formed incision. Alternatively, in an expanded state, the cut is curved, for example when penetrating a tissue wall with high self-sealing properties (e.g., the stomach wall), thus forming a curved incision to minimize penetration of the tissue wall. Optionally, the tissue wall is a thick tissue wall with a thickness greater than 1 mm, for example greater than 2 mm, greater than 3 mm, or any intermediate, smaller, or larger value.

[0077] The potential advantage of creating an opening with a maximum width in the tissue, for example, a maximum distance between two points on the incision, within a range between half the circumference of the sampling tube and the diameter of the sampling tube, allows the sampling tube to more easily penetrate a wall, such as the stomach wall, intestinal wall, and / or duodenal wall, while preventing leakage through the formed incision.

[0078] One aspect of some embodiments involves removing a wide tissue penetrator from target tissue through a narrow opening in a lumen of a biopsy tube. In some embodiments, at least a portion (e.g., a cut portion) of the wide tissue penetrator is reshaped to enter through the opening. In some embodiments, at least a portion of the tissue penetrator is contracted to a width less than a minimum width, such as the inner diameter of the biopsy tube opening. Optionally, at least a portion of the tissue penetrator is reversibly contracted to enter through the biopsy tube lumen opening. In some embodiments, at least a portion of the tissue penetrator is contracted into the biopsy tube lumen without tissue sampling.

[0079] According to some embodiments, at least a portion of the tissue penetrator is folded to pass through the opening into the biopsy tube lumen. In some embodiments, at least a portion of the tissue penetrator is at least partially rolled up or at least partially rolled up to obtain a shape whose cross-section is narrower than the opening of the biopsy tube lumen. In some embodiments, when the cutting portion is rolled up, two or more ends of the cutting portion overlap.

[0080] According to some embodiments, the cut portion of the tissue penetrator is reshaped by applying an external force to the tissue penetrator, for example, by retracting the tissue penetrator, for example, through the lumen of the biopsy tube. Alternatively, the cut portion is reshaped by rotating the tissue penetrator by at least 30°, for example at least 90°, 180°, 360°, or any intermediate, smaller, or larger degree of rotation. In some embodiments, the cut portion is reshaped by a force applied to the cut portion by the biopsy tube body.

[0081] According to some embodiments, the tissue penetrator is used for a biopsy sampling procedure of a tissue, such as a tissue suspected of being malignant.

[0082] According to some embodiments, an endoscope is guided toward a target tissue for which a sample needs to be taken. In some embodiments, upon reaching a tissue wall, such as a tissue wall surrounding the target tissue, a tissue penetrator expands through a distal opening of the endoscope. In some embodiments, the expansion of the tissue penetrator includes the expansion of the cutting portion of the tissue penetrator.

[0083] According to some embodiments, when the endoscope reaches a tissue wall of the desired target or reaches any tissue wall in a manner consistent with reaching a desired target tissue, the tissue penetrator is advanced distally into the endoscope and through the tissue wall. In some embodiments, the cutting portion of the tissue penetrator is advanced from the tissue wall incision by up to 5 cm, up to 3 cm, for example up to 1 cm, for example up to 0.5 cm, or any intermediate, smaller, or larger distance.

[0084] According to some embodiments, the tissue penetrator is part of a biopsy assembly including a biopsy tube. In some embodiments, when the endoscope reaches a tissue wall, the biopsy assembly, having expanded from a distal end of the biopsy tube, is advanced through the tissue wall. In some embodiments, when the biopsy assembly penetrates the tissue wall and optionally at least partially enters a target tissue, the tissue penetrator obstructs a lumen of the biopsy tube, thereby preventing tissue from penetrating into the biopsy tube.

[0085] According to some embodiments, after an incision is formed in the tissue wall, the tissue penetrator retracts into the lumen of the biopsy tube, for example to clear an internal lumen of the biopsy tube used for tissue sampling. In some embodiments, the biopsy tube is then advanced into the target tissue to sample the target tissue. In some embodiments, the biopsy tube is advanced into the target tissue while rotating, as described, for example, in WO2019155472A1. In some embodiments, performing tissue sampling includes advancing the biopsy tube into the target tissue once or more, for example, 2, 3, 4 times or any number of times.

[0086] According to some embodiments, the advancement (e.g., the degree of advancement) of at least one of the tissue penetrator, the biopsy tube, and / or the biopsy assembly is controlled by a handle or a control unit of a biopsy device, such as that described in WO2019155472A1.

[0087] According to some embodiments, the tissue wall comprises a muscle or any type of tissue located between a biopsy tube or any type of tube inserted into the body and a desired target tissue. A potential advantage of the tissue penetrator is that it allows penetration of a tissue wall with little or no sampling of the tissue wall, for example, less than 10%, less than 5%, or less than 1% of the tissue wall volume compared to the volume of the target tissue being sampled.

[0088] Although the examples provided in this application describe the use of a tissue penetrator having a biopsy tube, it should be understood that the tissue penetrator can be used with any tube inserted into the body, such as a drainage tube, feeding tube, guiding tube, insertion tube, drainage tube, dilator, catheter, injection needle, or any type of needle not used for injection, such as an aspiration needle.

[0089] Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not necessarily limited to the details of the construction and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. The present invention can have other embodiments or can be practiced or performed in various ways.

[0090] Exemplary tissue cutting process

[0091] According to some exemplary embodiments, during a biopsy sampling procedure, a biopsy tube (e.g., a biopsy needle) having an external distal cut is used to penetrate a tissue wall (e.g., a septum) toward a desired target tissue to be sampled. In some embodiments, to allow easy penetration of the sampling tube into the target tissue, an incision is formed in a tissue wall by the tissue penetrator, the tissue wall being located between the target tissue to be sampled and the biopsy tube. In some embodiments, the incision has a width at least as wide as the external width of the biopsy needle and less than half the external circumference of the biopsy tube. Referring now... Figure 1 It describes a process for cutting tissue by means of a retractable cutting portion according to some exemplary embodiments of the present invention.

[0092] According to some exemplary embodiments, at block 102, a tissue penetrator having a retractable cutting portion is advanced through a tissue wall. In some embodiments, the tissue penetrator is coupled to a biopsy tube (e.g., a biopsy needle). In some embodiments, at least a portion of the tissue penetrator is located within an inner lumen of the biopsy tube, while the retractable cutting portion of the tissue penetrator extends out of the biopsy tube. Optionally, the retractable cutting portion extends through a distal opening of the biopsy tube, such as an opening facing the tissue.

[0093] According to some exemplary embodiments, the tissue penetrator is secured to the biopsy tube, for example, when advanced through the tissue at frame 102. In some embodiments, the tissue penetrator is secured to the biopsy tube in an axial direction. Alternatively, the biopsy tube (e.g., a rotary biopsy needle) may rotate relative to the tissue penetrator. Alternatively, the tissue penetrator may rotate together with the biopsy tube.

[0094] According to some exemplary embodiments, at frame 104, the tissue penetrator forms a thin incision through the tissue. In some embodiments, the thin incision is formed by the retractable cutting portion of the tissue penetrator, for example, during advancement of the tissue penetrator at frame 102. In some embodiments, the incision formed by the retractable cutting portion has a width similar to or smaller than the maximum width of the biopsy tube. In some embodiments, the incision formed by the retractable cutting portion has a length similar to or smaller than the maximum width of the biopsy tube. In some embodiments, the length of the incision formed by the retractable cutting portion is similar to or smaller than the circumference of the biopsy tube or half of it.

[0095] According to some exemplary embodiments, the thin incision is formed in a tissue wall, such as in the stomach wall, duodenal wall, intestinal wall, and / or bronchial airway wall. In some embodiments, the tissue wall is elastic. In some embodiments, the thin incision formed in the tissue wall allows, for example, penetration of a biopsy tube with minimal force applied to the tissue, while preventing or limiting fluid leakage through the formed thin incision. Optionally, the thin incision allows, for example, improved self-sealing of the tissue wall after the biopsy tube has been removed from the body.

[0096] According to some exemplary embodiments, the retractable cutting portion in the expanded state is straight, for example, planar. In some embodiments, the straight retractable cutting portion is used to form a straight incision, for example when the tissue penetrator penetrates a tissue wall with limited self-sealing properties, such as the duodenal wall, intestinal wall, tracheal wall, bronchial airway wall, blood vessel wall, gastrointestinal wall, esophageal wall, or any wall of an anatomical passage. Alternatively, in an expanded state, the retractable cutting portion is curved. In some embodiments, the curved retractable cutting portion is used to form a curved incision, for example when penetrating a tissue wall with better self-sealing properties, such as the stomach wall or any anatomical septum, membrane, or tissue layer that at least partially surrounds a tissue or organ, such as the epithelium, skin, diaphragm, pleura, heart wall, and / or cardiac septum.

[0097] According to some exemplary embodiments, the thickness of the incision formed by the retractable cutting portion is less than a maximum width or an outer diameter of the biopsy tube.

[0098] According to some exemplary embodiments, the retractable cut portion of the tissue penetrator is reshaped, for example, contracted at frame 106. In some embodiments, at least a portion of the retractable cut portion contracts at frame 106. In some embodiments, the retractable cut portion is contracted to obtain a width smaller than the minimum width of an internal lumen of the biopsy tube. In some embodiments, the cut portion contracts upon reaching a target tissue to be sampled. Alternatively, the cut portion contracts when reaching a distance less than 5 mm from a target tissue to be sampled, such as less than 3 mm, less than 1 mm, less than 0.5 mm, or any intermediate, smaller, or larger distance.

[0099] According to some exemplary embodiments, the retractable cutting portion is contracted by applying a force to the tissue penetrator, for example by rotating and / or retracting the tissue penetrator relative to the sampling tube. Alternatively, the retractable cutting portion is contracted by applying a force to the sampling tube, for example by pushing, retracting, and / or rotating the sampling tube relative to the tissue penetrator.

[0100] According to some exemplary embodiments, at block 108, the tissue penetrator is removed from the tissue. In some embodiments, once the constriction is retracted at block 106, the tissue penetrator is removed from the tissue through the inner lumen of the sampling tube, for example, by retracting the tissue penetrator. In some embodiments, at block 108, the tissue penetrator is removed from the body. In some embodiments, the tissue penetrator is removed from the inner lumen of the sampling tube, for example, to allow a tissue sample to be inserted into the inner lumen of the biopsy tube. In some embodiments, the tissue penetrator is retracted into the biopsy tube lumen by a distance that clears a desired volume of the biopsy tube lumen, for example, a volume of at least 1 cubic millimeter, such as at least 3 cubic millimeters, at least 5 cubic millimeters, at least 1 cubic centimeter, or any intermediate, smaller, or larger volume within the biopsy tube lumen, to allow a tissue sample to enter the cleared volume.

[0101] Exemplary cutting section status

[0102] According to some exemplary embodiments, a cutting portion of a tissue penetrator moves between an expanded state and a contracted state. In some embodiments, the contracted state is irreversible and, for example, prevents reuse of the cutting portion. Alternatively, the contracted state is reversible and allows a return to an expanded state. In some embodiments, in a contracted state, a maximum width of the cutting portion is less than a minimum width of an internal lumen of a biopsy tube, for example, to allow removal of the tissue penetrator from the tissue through the internal lumen of the biopsy tube. Referring now to... Figure 2AIt depicts the transition between an expanded state and a contracted state of the tissue penetrator cutting portion according to some exemplary embodiments of the present invention.

[0103] According to some exemplary embodiments, in an expanded state 202, at least a portion of the cutting portion of a tissue penetrator is expanded. In some embodiments, the cutting portion extends from an opening in the internal lumen of a biopsy tube. In some embodiments, the cutting portion extends and faces tissue located in an advance path of the tissue penetrator. In some embodiments, in an expanded state, a maximum width of the cutting portion is greater than or similar to the maximum outer width of the biopsy tube, such as the maximum outer diameter.

[0104] According to some exemplary embodiments, in a reshaping state, such as in a reshaping state 204, at least a portion of the tissue penetrator (e.g., at least a portion of the cutting portion) is contracted. In some embodiments, at least a portion of the cutting portion is contracted to obtain a maximum width of the cutting portion, the maximum width being less than a minimum width of the internal lumen of the biopsy tube. In some embodiments, in a contracted state, the shape and size of the tissue penetrator are designed to be movable into the internal lumen of the biopsy tube.

[0105] According to some exemplary embodiments, the cutting portion of the tissue penetrator is reversibly movable between an expanded state 202 and a contracted state. Alternatively, the cutting portion is irreversibly moved to a contracted state. In some embodiments, the cutting portion of the tissue penetrator is moved between an expanded state 202 and a contracted state 204 by axially moving one or both of the biopsy tube and the tissue penetrator (or a portion thereof). Alternatively or additionally, the cutting portion of the tissue penetrator is moved between an expanded state 202 and a contracted state 204 by rotating one or both of the biopsy tube and the tissue penetrator (or a portion thereof).

[0106] Exemplary cut

[0107] According to some exemplary embodiments, the tissue penetrator (e.g., a retractable cutting portion of the tissue penetrator) is configured to make all openings through the tissue. In some embodiments, the shape and size of a cutting edge of the retractable cutting portion are designed to make all openings through a tissue wall, such as through a tissue layer surrounding a region of the tissue. In some embodiments, the tissue layer is a resilient tissue layer. For example, a tissue layer located between a tube (e.g., a sampling tube) and a target tissue to be sampled. In some embodiments, the tissue wall includes any wall of the abdominal wall, stomach wall, duodenal wall, intestinal wall, bronchial wall, blood vessel wall, gastrointestinal tract wall, esophageal wall, or anatomical passage.

[0108] Now for reference Figure 2B and Figure 2C It depicts the formation of a straight incision through tissue (e.g., a tissue wall) according to some exemplary embodiments of the present invention.

[0109] According to some exemplary embodiments, a sharp cutting edge of a retractable cutting portion of a tissue penetrator is configured to form a thin, straight incision, such as a straight incision 210, through the tissue. In some embodiments, a length 214 of the straight incision 210 is in the range of 2 to 30 millimeters, for example, 2 to 8 millimeters, 5 to 10 millimeters, 8 to 15 millimeters, 13 to 20 millimeters, or any intermediate, shorter, or longer incision. In some embodiments, a length 214 of the straight incision is equal to or greater than a diameter 216 of a tube 212 (e.g., a biopsy tube) that needs to penetrate the straight incision. In some embodiments, the length of the incision 214 is selected based on the tissue type and / or a diameter of the tube, for example, being long enough on one side to allow penetration of the tube without applying a high level of force to the tube, thus allowing easy use and not causing high pressure on the tissue that could lead to tissue rupture, and / or not too long on the other side, for example, to prevent leakage through the incision once the tube has been removed from the tissue.

[0110] In some embodiments, the thickness of the straight incision 210, such as the distance between two opposite edges of the straight incision, is less than 0.5 mm, for example less than 0.4 mm, less than 0.2 mm, less than 0.1 mm, or any intermediate, smaller, or larger value. In some embodiments, the ratio of a maximum width 214 of the straight incision 210 (e.g., the maximum distance between two points on the incision) to a thickness of the straight incision is greater than 5:1, for example greater than 10:1, greater than 15:1, greater than 20:1, greater than 100:1, or any intermediate, smaller, or larger ratio. In some embodiments, the cutting edge of a retractable cutting portion of a tissue penetrator forms a straight incision in a tissue wall with low elasticity and / or low self-sealing properties, such as the intestinal tissue wall or the duodenal tissue wall.

[0111] Now for reference Figure 2D It depicts the formation of a curved incision through tissue (e.g., tissue wall) according to some exemplary embodiments of the present invention.

[0112] According to some exemplary embodiments, a sharp cutting edge of a retractable cutting portion of a tissue penetrator is configured to form a thin, curved incision through the tissue, such as an arcuate incision, for example, a curved incision 220. In some embodiments, the length of the curved incision 220 is in the range of 0.5 to 30 mm, for example, 1 to 8 mm, 5 to 10 mm, 8 to 15 mm, 13 to 20 mm, or any intermediate, shorter, or longer incision. In some embodiments, a maximum width of the curved incision (e.g., the maximum distance between two locations on the curved incision) is greater than a diameter 228 of a tube 222 (e.g., a biopsy tube) that needs to penetrate the curved incision, for example... Figure 2D As shown.

[0113] According to some exemplary embodiments, the radius of curvature of the curved incision is in the range of 0.2 to 20 mm, for example, 0.2 to 8 mm, 5 to 10 mm, 7 to 15 mm, 10 to 20 mm, or any intermediate, smaller, or larger value. In some embodiments, the diameter of curvature of the curved incision 220 is at least an outer diameter 228 of a tube (e.g., a tube 222 that needs to penetrate the incision 220). In some embodiments, the length and / or radius of curvature of the incision 220 are selected based on the tissue type and / or tissue elasticity and / or the diameter of the tube, for example, to allow the tube to penetrate without applying a high level of force that could cause tissue rupture, and / or to prevent leakage through the incision after the tube is removed from the tissue.

[0114] In some embodiments, the thickness (e.g., the distance between two opposite edges of the curved incision 220) is less than 0.5 mm, such as less than 0.4 mm, less than 0.2 mm, less than 0.1 mm, less than 0.01 mm, or any intermediate, smaller, or larger value. In some embodiments, the ratio between the length or maximum width of the curved incision 220 and the thickness of the curved incision is greater than 5:1, such as greater than 10:1, 15:1, greater than 20:1, greater than 100:1, or any intermediate, smaller, or larger ratio. In some embodiments, the cutting edge of the retractable cutting portion of a tissue penetrator forms a curved incision in a tissue wall (e.g., the gastric tissue wall) that is elastic and / or has high self-sealing properties.

[0115] Exemplary tissue sampling process

[0116] According to some exemplary embodiments, a biopsy tube (e.g., a biopsy needle) is advanced through body tissue to reach a desired target tissue for which direct sampling or sampling through a tissue wall is required. In some embodiments, a tissue penetrator is coupled to the biopsy tube, for example, reversibly coupled, to allow easy penetration of the tissue during advancement of the biopsy tube. In some embodiments, at least a portion of the tissue penetrator (e.g., a cutting portion of the tissue penetrator) is located at the tip of the biopsy tube and faces the tissue.

[0117] According to some exemplary embodiments, the shape and size of the cutting portion of the tissue penetrator are designed to penetrate the tissue while forming an incision wider than a maximum width of the biopsy tube following the tissue penetrator. Additionally, the incision formed by the cutting has a thickness of less than 2 mm, for example less than 1 mm, less than 0.1 mm, or any intermediate, smaller, or larger value.

[0118] According to some exemplary embodiments, once an opening is formed, the tissue penetrator is removed from the tissue, for example, through the lumen of the sampling tube. Reference now. Figure 3 It describes a tissue sampling process using a tissue penetrator according to some exemplary embodiments of the present invention.

[0119] According to some exemplary embodiments, a tissue penetrator is provided at block 302, the tissue penetrator being coupled to a biopsy tube (e.g., a biopsy needle). In some embodiments, an assembly, such as a biopsy assembly or kit, is provided at block 302, which includes a tissue penetrator and a biopsy tube. In some embodiments, the tissue penetrator is disposed within an inner lumen of the biopsy tube. Alternatively, at least a portion of the tissue penetrator (e.g., a cutting portion of the tissue penetrator) extends from the biopsy tube and is located distally to the biopsy tube. In some embodiments, the cutting portion extends through a distal opening of an inner lumen of the biopsy tube facing the tissue.

[0120] According to some exemplary embodiments, at block 304, the biopsy assembly is advanced through body tissue toward a target tissue. In some embodiments, the biopsy assembly is advanced by applying an axial force to one or both of the tissue penetrator and the biopsy tube. In some embodiments, the biopsy assembly is advanced while visualized from outside the body, for example using an imaging system such as ultrasound, X-ray, or any other imaging system.

[0121] According to some exemplary embodiments, at block 306, the biopsy assembly reaches a desired target area. In some embodiments, at block 306, the biopsy device reaches a desired distance from a target area, such as 10 cm, 5 cm, 2 cm, or any intermediate, smaller, or larger distance from the target area.

[0122] According to some exemplary embodiments, at block 308, the tissue penetrator is retracted. In some embodiments, the retraction of the tissue penetrator separates the biopsy tube from the tissue penetrator while optionally retaining the biopsy tube in the same position. In some embodiments, the tissue penetrator is retracted axially relative to the biopsy tube.

[0123] According to some exemplary embodiments, at block 310, at least a portion of the cut portion is reshaped, for example, shrunken, rolled up, and / or rolled up. In some embodiments, at block 310, the reshaped cut portion is inserted into the inner lumen of the biopsy tube. In some embodiments, retraction and / or rotation of the tissue penetrator causes reshaping, for example, collapse of the cut edge of the tissue penetrator. In some embodiments, during reshaping, the cut edge acquires a shape and / or size to allow, for example, the reshaped insertion into the inner lumen of the biopsy tube. In some embodiments, in the reshaped state, a maximum width or diameter of the cut portion is smaller than a minimum width or minimum diameter of an inner lumen of the biopsy tube. In some embodiments, reshaping the cut portion and inserting the cut portion into the biopsy tube lumen are performed simultaneously. Alternatively, reshaping the cut portion and inserting the cut portion into the biopsy tube lumen are performed sequentially, for example, by applying forces in different directions and / or at two separate time points.

[0124] According to some exemplary embodiments, at block 312, the tissue penetrator is removed from the inner lumen of the biopsy tube (e.g., a biopsy needle). In some embodiments, the tissue penetrator is removed from the inner lumen, for example, to allow a tissue sample to enter the inner lumen. In some embodiments, the tissue penetrator is removed by retracting it back into the inner lumen.

[0125] According to some exemplary embodiments, the tissue penetrator is completely removed from the internal lumen of the sampling tube, and optionally removed outside the body. Alternatively, the tissue penetrator is partially removed, for example, to empty a predetermined volume of the biopsy tube lumen. In some embodiments, the predetermined volume is emptied to allow, for example, sampling a predetermined volume of tissue sample.

[0126] According to some exemplary embodiments, body tissue is sampled at block 314. In some embodiments, during body tissue sampling, the biopsy tube (e.g., a biopsy needle) is advanced into the body tissue while a sample of the body tissue is pushed into the inner lumen of the biopsy tube.

[0127] Exemplary tissue penetrator and biopsy component

[0128] Now for reference Figure 4A and Figure 4B It depicts a biopsy assembly according to some exemplary embodiments of the present invention, the biopsy assembly including a biopsy tube and a tissue penetrator.

[0129] According to some exemplary embodiments, a biopsy assembly (e.g., assembly 400) includes a tissue penetrator 402 and a biopsy tube 404. In some embodiments, the tissue penetrator 402 is reversibly coupled to the biopsy tube 404. In some embodiments, such as Figure 4A and Figure 4B As shown, at least a portion of the tissue penetrator is disposed within an internal lumen 406 of the biopsy tube 404.

[0130] According to some exemplary embodiments, a tissue penetrator (e.g., tissue penetrator 402) includes an elongated body 408 and a cutting portion 410 located on the elongated body (e.g., a portion closer to body tissue). Optionally, the cutting portion is located at a distal end of the elongated body, for example, the end of the elongated body closer to body tissue. Optionally, the tissue penetrator includes a tip 412, such as a conical tip. In some embodiments, the tip 412 is at least partially angled. In some embodiments, the shape and size of the tip 412 are designed to allow easy penetration of body tissue, for example, as the tissue penetrator advances through body tissue. In some embodiments, the tip 412 is part of the cutting portion 410. Alternatively, the tip 412 is located distal to the cutting portion 410.

[0131] According to some exemplary embodiments, the cutting portion 410 (e.g., a retractable cutting portion) includes a cutting edge 411. In some embodiments, the cutting edge 411 is located on a distal surface of the cutting portion 410, the distal surface facing a tissue. Optionally, the cutting edge 411 is a leading edge of the cutting portion 410.

[0132] According to some exemplary embodiments, the cut edge 411 is sharp. Additionally or alternatively, in some embodiments, the cut is thin, for example, having a thickness of less than 0.5 mm, such as less than 0.3 mm, less than 0.1 mm, or any intermediate, smaller, or larger value. In some embodiments, the length of the cut edge 411 is in a range of 2 to 50 mm, such as 5 to 10 mm, 8 to 15 mm, 12 to 20 mm, 15 to 30 mm, or any intermediate, smaller, or larger value. In some embodiments, the ratio of the length or maximum width of the cut edge (e.g., the maximum distance between two points on the cut edge) to a thickness is at least 10:1, such as at least 20:1, at least 30:1, or any intermediate, smaller, or larger ratio value. In some embodiments, the ratio of the length of the cut edge 411 to a maximum width / diameter of the cut edge is at least 2:1, such as at least 5:1, at least 20:1, or any intermediate, smaller, or larger ratio.

[0133] According to some exemplary embodiments, the cutting edge 411 is planar, for example, straight. In some embodiments, the planar cutting edge is used to make a straight cut, for example... Figure 2B and Figure 2C As described in [the text].

[0134] According to some exemplary embodiments, the cut edge 411 is curved. In some embodiments, the curved cut edge has a radius of curvature in a range of 0.2 to 20 mm, such as 0.2 to 5 mm, 5 to 10 mm, 7 to 15 mm, 10 to 20 mm, or any intermediate, smaller, or larger value.

[0135] According to some exemplary embodiments, a specific tissue penetrator with a specific type of cutting edge is selected based on the type of tissue to be cut. For example, when an incision needs to be made in a tissue wall with low elasticity (e.g., the wall of the intestine or duodenum), a tissue penetrator with a flat cutting edge is selected. Alternatively, when an incision needs to be made in an elastic tissue (e.g., the stomach wall), a tissue penetrator with a curved cutting edge is selected. Alternatively or additionally, a specific type of penetrator with a specific cutting edge is selected based on the outer diameter of a tube that needs to penetrate the formed incision.

[0136] According to some exemplary embodiments, the elongated body 408 includes an axis. In some embodiments, the elongated body 408 is flexible and bendable, for example, to allow bending while at least one of the component 400, the biopsy tube 404, and / or the tissue penetrator 402 is guided toward a desired target area in the body. In some embodiments, the elongated body can be bent at least 40 degrees, for example at least 45 degrees, at least 60 degrees, at least 70 degrees, or any intermediate, smaller, or larger angle. In some embodiments, the elongated body is formed of stainless steel, steel, alloy steel (e.g., cobalt-chromium), a superelastic alloy (e.g., nickel-titanium), or a shape memory alloy.

[0137] According to some exemplary embodiments, a width 409 of the elongated body 408 is up to 95% of the width 418 of the inner lumen 406, such as up to 90%, up to 80%, or any intermediate, smaller, or larger percentage value, to, for example, allow the tissue penetrator 402 to support the biopsy tube 404 during navigation to a desired target area. In some embodiments, a thickness of a wall 413 surrounding the inner lumen 406 is at least 5% of the inner width or inner diameter of the inner lumen 406 of the biopsy tube, such as at least 10%, at least 20%, at least 30%, or any intermediate, smaller, or larger percentage value.

[0138] According to some exemplary embodiments, the maximum width or maximum diameter of the elongated body 408 of the tissue penetrator is in the range of 0.30 to 7 mm, for example, 0.3 to 1 mm, 0.8 to 2 mm, 1.5 to 3 mm, 2 to 4 mm, 3.5 to 5 mm, 4.5 to 7 mm, or any intermediate, smaller, or larger value. In some embodiments, the maximum width or maximum diameter of the internal lumen 406 is at least 0.02 mm larger than the maximum diameter of the elongated body of the tissue penetrator, for example, at least 0.5 mm, at least 1 mm, at least 3 mm, or any intermediate, smaller, or larger value.

[0139] According to some exemplary embodiments, the cutting portion 410 is a reformable cutting portion and is configured to move from an expanded state to a contracted state, such as... Figure 2A As described herein. In some embodiments, in an expanded state, for example... Figure 4A As shown, the cutting portion is located on the outside and distal side of the biopsy tube 404. In some embodiments, the cutting portion 410 is mechanically connected to a portion of the body 408 extending from the lumen 406 of the biopsy tube, for example through a distal opening 416. Alternatively, the cutting portion 410 is an integrated part of the elongated body 408.

[0140] According to some exemplary embodiments, in an expanded state, such as Figure 4A As shown, a maximum width 414 of the cutting portion 410 is greater than a maximum width 418 or a maximum diameter of the internal lumen 406. In some embodiments, in an expanded state, a maximum width 414 of the cutting portion 410 is greater than a maximum width or a maximum diameter of the distal opening 416 of the internal lumen. In some embodiments, the maximum width 414 of the cutting portion 410 is in the range of 0.40 to 8 mm.

[0141] According to some exemplary embodiments, in an expanded state, the cut portion includes a single, continuous distal cutting edge facing the tissue. Alternatively, the cut portion includes two or more distally extending portions, each portion having a distal cutting edge facing the tissue. Alternatively, the cut portion includes two or more distally extending portions of a single, continuous cutting edge. In some embodiments, the cut portion extends distally to form the tip 412.

[0142] According to some exemplary embodiments, the cutting portion is reshaped to enter the internal lumen 406 of the biopsy tube, such as... Figure 4B As shown. In some embodiments, the cutting portion is reshaped by retracting and / or rotating the tissue penetrator 402 (e.g., the tissue penetrator body 408). In some embodiments, the tissue penetrator body is retracted and / or rotated from outside the body. In some embodiments, in a reshaped state (e.g., a retracted state), a maximum width or diameter of the cutting portion is smaller than an internal width or diameter of the internal lumen 406, for example to allow the tissue penetrator 402 to be removed from the body through the internal lumen of the biopsy tube, for example. Figure 3 As described in box 312.

[0143] According to some exemplary embodiments, retraction and / or rotation of the tissue penetrator body 408 causes at least a portion of the cutting portion 410 to curl or roll up, for example, to obtain a desired shape having a smaller dimension, such as width or diameter, relative to the size of the internal lumen 406. Alternatively or additionally, retraction and / or rotation of the tissue penetrator body 408 causes at least a portion of the cutting portion to contract, for example, to obtain the desired shape. In some embodiments, retraction and / or rotation of the tissue penetrator body 408 causes two or more ends of the cutting portion to bend until they overlap.

[0144] Now for reference Figure 5A and Figure 5B It depicts the connection between a tissue penetrator and a biopsy tube according to some exemplary embodiments of the present invention.

[0145] According to some exemplary embodiments, the tissue penetrator is coupled to the biopsy tube, for example, during the navigation of the biopsy assembly to a target region in the body. In some embodiments, the tissue penetrator is reversibly coupled to the biopsy tube, for example, to allow the tissue penetrator to be removed before or during tissue sampling.

[0146] According to some exemplary embodiments, the coupling of the tissue penetrator to the biopsy tube allows the biopsy tube to support the distally extending cut against external pressure applied to the cut portion, such as during navigation. In some embodiments, such as Figure 4A As shown, during navigation, the cutting portion 410 is pressed against a distal end of the biopsy tube body 415, for example, around the edge of the opening 416. In some embodiments, the shape and configuration of the cutting portion are pressed against the biopsy tube body 415 without retracting.

[0147] According to some exemplary embodiments, a minimum thickness of one wall of the biopsy tube body is at least 5% of the inner diameter of the biopsy tube, such as at least 10%, at least 15%, at least 20%, or any intermediate, smaller, or larger percentage value. In some embodiments, a minimum thickness of the wall of the biopsy tube body is at least 0.03 mm, such as at least 0.05 mm, at least 0.07 mm, at least 0.1 mm, or any intermediate, smaller, or larger value.

[0148] According to some exemplary embodiments, for example Figure 5A As shown, the coupling between the tissue penetrator 402 and the biopsy tube 404 is generated by a coupler 504 located at a proximal segment 502 of the biopsy tube 404. In some embodiments, the coupler 504 mechanically couples the biopsy tube 404 and the tissue penetrator 402 during navigation toward a target region. In some embodiments, the coupler fixes a position of the tissue penetrator 402 in an axial direction relative to the biopsy tube 404, while optionally allowing the biopsy tube and / or the tissue penetrator to rotate relative to each other. In some embodiments, the coupler 504 includes a reversible lock, such as a reversible interlocking mechanism. In some embodiments, a force applied to the cutting portion presses the tissue penetrator against the interlocking mechanism. In some embodiments, the interlocking mechanism transmits at least a portion of the applied force to the biopsy tube.

[0149] According to some exemplary embodiments, for example Figure 5BAs shown, the release of the interlocking mechanism allows, for example, the reshaping of the cutting portion and / or the retraction of the tissue penetrator 402 through the lumen of the biopsy tube 502. In some embodiments, the separation of the tissue penetrator 402 from the biopsy tube 404 is irreversible. Optionally, the coupler 504 is part of a mechanism for the rotation and / or retraction of the tissue penetrator to allow the reshaping of the cutting portion.

[0150] Exemplary organization penetration

[0151] According to some exemplary embodiments, a biopsy assembly includes a biopsy tube and a tissue penetrator, the biopsy assembly being advanced through body tissue toward a desired target region. In some embodiments, at least a portion (e.g., a cutting portion) of the tissue penetrator is located distal to the biopsy tube, and its shape and size are designed to penetrate and make an incision as the assembly is advanced toward the target region. In some embodiments, the incision formed by the cutting portion allows, for example, the biopsy tube located proximal to the cutting portion to easily penetrate the tissue. Referring now to... Figures 6A to 6E The invention describes tissue penetration according to some exemplary embodiments.

[0152] According to some exemplary embodiments, a biopsy assembly 602 includes a tissue penetrator 604 and a biopsy tube 606. In some embodiments, prior to penetrating tissue, the tissue penetrator body 608 is located within an inner lumen 609 of the biopsy tube, and a cutting portion 610 of the tissue penetrator 604, connected to the tissue penetrator body 608, extends distally from the biopsy tube 606. In some embodiments, when the cutting portion extends from the biopsy tube, the cutting portion is in an expanded state, wherein a maximum width of the cutting portion is greater than or has a width similar to the outer width of the biopsy tube (e.g., an outer diameter).

[0153] According to some exemplary embodiments, the tissue penetrator includes a distal tip (e.g., a sharp distal tip 612) located distal to the cutting portion. In some embodiments, the distal tip is an integrated portion of the cutting portion 610. Alternatively, the distal tip is an integrated portion of the tissue penetrator body 608, for example, in embodiments where the tissue penetrator body extends from the biopsy tube and is connected to the cutting portion.

[0154] According to some exemplary embodiments, for example Figure 6BAs shown, when the biopsy assembly 602 is advanced and passes through tissue 614, the tip 612 penetrates the tissue 614, while the expanded cutting portion 610 forms a thin incision 616. The thin incision 616 has a width wider than that located proximally to the biopsy tube 606, or a width similar to that of the biopsy tube 606 located proximally to the biopsy tube 606. In some embodiments, as the tissue penetrator advances through the tissue, the tissue exerts a force on the cutting portion. In some embodiments, the force applied to the cutting portion pushes the cutting portion against the biopsy tube, structurally supporting the cutting portion without causing reshaping, such as shrinkage of the cutting portion. Alternatively, a coupler (e.g.) Figure 5A and Figure 5B The coupler 504 shown structurally supports the tissue penetrator body against the force applied to the cutting portion 610.

[0155] According to some exemplary embodiments, such as Figure 6B As shown, once the biopsy assembly 602 has reached a desired target area in the tissue, the tissue penetrator 604 is removed from the tissue 614. In some embodiments, the biopsy tube 606 remains in the same position when the tissue penetrator 604 is removed. In some embodiments, the cutting portion 610 is reshaped (e.g., shrunk), for example, to obtain a shape and / or size that can be fitted into the internal lumen 609 of the biopsy tube 606.

[0156] According to some exemplary embodiments, such as Figure 6C As shown, the cutting portion 610 is reshaped, for example, by retraction and / or rotation of the body 608. In some embodiments, retraction of the tissue penetrator body 608 causes the cutting portion to retract, for example, during and / or before entering the biopsy tube lumen 609.

[0157] According to some exemplary embodiments, such as Figure 6D As shown, the tissue penetrator is removed from the body. In some embodiments, the biopsy tube is advanced into the tissue and at least partially passes through the incision 616, for example... Figure 6E As shown. In some embodiments, the incision 616 allows easy access to the biopsy tube, for example, through the tissue wall 611. Alternatively or additionally, the shape and / or size of the incision allows for tissue self-sealing, for example, to prevent leakage through the incision in the tissue wall when the biopsy tube is retracted.

[0158] Exemplary cut section reshaping

[0159] According to some exemplary embodiments, a tissue penetrator includes a longitudinal axis, a distal segment, and a proximal segment, the distal segment being adapted to contact a tissue. In some embodiments, a retractable cutting portion is located in the distal segment, the retractable cutting portion being configured to reshape and obtain a narrow shape, such as a narrow shape adapted to enter an internal lumen of a biopsy tube. In some embodiments, the cutting portion includes a cutting edge located on an outer surface of the cutting portion facing a tissue. In some embodiments, an elongated body connected to the cutting portion is located in the proximal segment. Optionally, the cutting portion and the elongated body are integrated as a single unit.

[0160] According to some exemplary embodiments, the cut portion is reshaped by a force applied to it by a biopsy tube, the tissue penetrator body being disposed within the biopsy tube. In some embodiments, the cut portion is flexible, for example to allow the cut portion to contract. Alternatively, the cut portion is elastic, for example to allow the cut portion to contract and return to its previously expanded shape. Referring now... Figures 7A to 7F The image depicts the reshaping of the cut portion according to some exemplary embodiments of the present invention.

[0161] According to some exemplary embodiments, a tissue penetrator (e.g., a tissue penetrator 702) includes a proximal elongated body 704, a distal cutting portion 706, and a longitudinal axis 716, the distal cutting portion 706 being connected to the proximal elongated body. In some embodiments, the tissue penetrator 702 is at least partially disposed within an internal lumen 708 of a biopsy tube 710. In some embodiments, for example... Figure 7A As shown, the cutting portion extends distally at least partially from the internal cavity 708.

[0162] According to some exemplary embodiments, the cross-section or projection of the cutting portion (e.g., cutting portion 706) is rhomboid, triangular, or a triangle or rhomboid with a bend or oblique angle. In some embodiments, the cutting portion is a retractable cutting portion and is configured to retract inward toward the longitudinal axis 716 of the tissue penetrator. In some embodiments, the cutting portion is configured to retract inward at one or more contact points, such as contact points 712 and 714 between the cutting portion 706 and the biopsy tube 710, in response to an inward force applied, for example, to opposite sides of the cutting portion 706 by the biopsy tube 710.

[0163] According to some exemplary embodiments, for example Figure 7B As shown, the inward contraction reshapes the cut portion 706 to have a maximum width that is smaller than a minimum width of the internal lumen 708 of the biopsy tube.

[0164] According to some exemplary embodiments, during the advancement of the tissue penetrator 702 and the biopsy tube 710 through the tissue, at one or more contact points, the biopsy tube 710 supports the cut portion 706 against forces exerted by the tissue on the cut portion 706. In some embodiments, the force exerted by the tissue is lower than the force value required to cause reshaping. In some embodiments, the cut portion is shaped to resist force values ​​up to 0.5 to 5 Newtons (N) without reshaping (e.g., by abutting against the biopsy tube 710), such as 0.5 to 2 Newtons, 1 to 3 Newtons, 2 to 5 Newtons, or any intermediate, smaller, or larger range of values. In some embodiments, the retraction of the tissue penetrator exceeds the force value, resulting in the reshaping of the cut portion.

[0165] According to some exemplary embodiments, for example Figure 7C As shown, the cutting portion 718 has a triangular cross-section, wherein one base of the triangle 719 abuts against the biopsy tube body 710, for example, during the passage through body tissue.

[0166] According to some exemplary embodiments, one wall 720 of the tissue penetrator is positioned between the tissue penetrator wall and the tissue penetrator body 721 at an angle of less than 20 degrees, such as less than 15 degrees, less than 10 degrees, or any intermediate, smaller, or larger angle. In some embodiments, the wall 720 rests against the biopsy tube 710, for example, to support the cutting portion 718 against forces exerted on the cutting portion by tissue without causing the cutting portion to reshape.

[0167] According to some exemplary embodiments, the tissue penetrator body 721 is retracted by applying force to the cutting portion 718 via the biopsy tube 710, causing the cutting portion 718 to retract inward, for example, toward the longitudinal axis 716. In some embodiments, for example Figure 7D As shown, in a contracted state, the maximum width of the cutting portion is less than the minimum width of the internal lumen 708 of the biopsy tube.

[0168] According to some exemplary embodiments, such as Figure 7E As shown, a tissue penetrator includes a distal cutting portion 732 connected to or integrated with a proximal body 734. In some embodiments, the tissue penetrator 730 includes a stop 736 located proximal to the cutting portion 732 when the cutting portion is in an expanded state, for example, between the cutting portion 732 and a biopsy tube body 738. In some embodiments, during the advancement of the tissue penetrator 730 through tissue, the force exerted by the tissue on the cutting portion 732 pushes the stop 736 against the biopsy tube body 738.

[0169] According to some exemplary embodiments, the stop 736 is configured to resist pressure exerted on the tissue penetrator by the biopsy tube body 738 during advancement through tissue without causing the cut portion 732 to reshape, for example, shrink. In some embodiments, the stop is configured to prevent direct contact between the biopsy tube body 738 and the cut portion 732. In some embodiments, such as during advancement through tissue, the stop is reversibly mechanically coupled to the biopsy tube body 738. In some embodiments, the stop is coupled to the proximal body 734.

[0170] According to some exemplary embodiments, for example Figure 7F As shown, the retraction of the tissue penetrator 730 applies a force to the stop 736 that is greater than the force the stop 736 can resist. In some embodiments, during the retraction of the tissue penetrator 730 relative to the biopsy tube 738, the force applied to the stop 736 deforms the stop 736. In some embodiments, the deformation of the stop results in direct contact between the biopsy tube 738 and the cutting portion 730, such as a retractable cutting portion, thereby causing the cutting portion 730 to retract, for example... Figure 7B In some embodiments, the stop is configured to resist pressures up to 0.5 to 5 N, such as 0.5 to 2 N, 1 to 3 N, 2.5 to 4 N, 3.5 to 5 N, or any intermediate, smaller, or larger range of values.

[0171] Now for reference Figure 7G It depicts a penetration angle between a cutting portion of a tissue penetrator and a tissue wall, and an angle between the cutting portion and the biopsy tube, according to some exemplary embodiments of the present invention.

[0172] According to some exemplary embodiments, a tissue penetrator (e.g., a tissue penetrator 750) includes a cutting portion 752, such as a retractable portion. In some embodiments, at least one outer surface of the cutting portion 752 is a non-planar surface, such as a curved or angled outer surface. In some embodiments, at least one outer surface of the cutting portion 752 facing a tissue, such as a tissue wall 754, is non-planar, such as surface 756.

[0173] According to some exemplary embodiments, an outer surface (e.g., surface 756) of the cut portion 752 facing a tissue is positioned at an angle 758 between the surface 756 and the tissue wall, the angle being greater than 45 degrees, for example, any intermediate, smaller, or larger angle greater than 50 degrees, greater than 60 degrees, greater than 70 degrees, or greater than 87 degrees. In some embodiments, an angle greater than 45 degrees between the outer surface of the cut portion facing the tissue and the tissue allows, for example, penetration into the tissue while applying a low axial force through the cut portion 752 on the tissue 754.

[0174] According to some exemplary embodiments, an outer surface of the cutting portion 752 (e.g., a surface 760 facing a biopsy tube 762, in which a tissue penetrator is disposed) is positioned at an angle relative to the biopsy tube 762. In some embodiments, an angle 764 between the biopsy tube 762 and the surface 760 is greater than 45 degrees, for example, an angle greater than 50 degrees, greater than 60 degrees, greater than 70 degrees, greater than 87 degrees, or any intermediate, smaller, or larger angle. In some embodiments, an angle greater than 45 degrees between the outer surface of the cutting portion facing the biopsy tube and the tissue biopsy tube and the tissue allows the cutting portion to be retracted, for example, by applying a relatively low axial force to the penetrator body 734 via the biopsy tube 762, for example, by retracting the penetrator body into an inner lumen of the biopsy tube.

[0175] Now for reference Figure 7H It depicts a tissue penetrator with curved sidewalls according to some exemplary embodiments of the present invention.

[0176] According to some exemplary embodiments, a tissue penetrator (e.g., a tissue penetrator 770) includes a cutting portion 772 (e.g., a retractable cutting portion) connected to an elongated body 776. In some embodiments, the cutting portion 772 includes a distal tip, connected, for example, to a distal tip 771 of the elongated body 776 via side surfaces 774 and 775 (e.g., side surfaces). In some embodiments, for example... Figure 7H As shown, side surfaces 774 and 775 are curved, for example, not angled. In some embodiments, the side surfaces are curved when the cutting portion is in an expanded state, such as when the cutting portion extends from the internal lumen of the biopsy tube body 738. Optionally, the distal tip of the cutting portion is curved. Optionally, an outer edge of the cutting portion is entirely arcuate. Alternatively, at least a portion of the outer edge is curved.

[0177] Exemplary tissue penetrator with curved cutting section

[0178] Now for reference Figures 8A to 8E It depicts a tissue penetrator having a curved cutting portion according to some exemplary embodiments.

[0179] According to some exemplary embodiments, a tissue penetrator 800 includes an elongated body 806 having a proximal segment 802 and a distal segment 804. In some embodiments, the elongated body 806 includes an elongated shaft. In some embodiments, the elongated shaft is flexible, for example, to allow the tissue penetrator to bend as it is advanced through a sleeve (e.g., an endoscope). In some embodiments, the elongated shaft includes a distal tip 808. In some embodiments, the distal tip 808 is closed, for example, to prevent tissue from penetrating into the elongated shaft. Optionally, the distal tip 808 is angled. Optionally or additionally, the distal tip 808 is at least partially pointed, for example, to allow easy penetration of tissue.

[0180] According to some exemplary embodiments, a cutter (e.g., a cutting portion 810) is mechanically connected to a distal segment 804 of the elongated body 806, for example, to a distal segment of the elongated shaft. In some embodiments, the distal tip 808 is located distal to the cutting portion 810. In some embodiments, the cutting portion 810 is at least partially bent.

[0181] According to some exemplary embodiments, the cutting portion 810 has a curved surface that bends about a longitudinal axis of the tissue penetrator, for example, about a longitudinal axis of the elongated body 806. In some embodiments, a maximum length of the curved surface perpendicular to the elongated body is greater than a width of the elongated body. In some embodiments, an arc length of the curved surface is fixed. Alternatively, the arc length varies along a longitudinal axis of the elongated body 806. In some embodiments, a range of the maximum arc length of the curved surface is 0.8 to 20 mm, for example 0.8 to 3 mm, 1 to 5 mm, 3 to 7 mm, 6 to 10 mm, 8 to 15 mm, 13 to 20 mm, or any intermediate, smaller, or larger value range. In some embodiments, the ratio between the total width of the curved surface 810 of the cutting portion and the width or diameter of the elongated body 806 is in a range between 1:1 and 15:1. In some embodiments, the maximum length of the cut portion 810 along the longitudinal axis of the elongated body 806 is in the range of 1 to 60 mm, for example 1 to 10 mm, 8 to 20 mm, 15 to 30 mm, 20 to 40 mm, 30 to 50 mm, 40 to 60 mm or any intermediate, smaller or larger value range.

[0182] According to some exemplary embodiments, an outer edge of the cutting portion 810 extending on both sides of the elongated body 806 is at least partially tapered, for example, to allow cutting of tissue as the tissue penetrator is axially advanced into the tissue. In some embodiments, a maximum thickness 822 of the cutting portion 810 (e.g.) Figure 9B (as shown) less than 0.1 mm, for example less than 0.8 mm, less than 0.6 mm, less than 0.5 mm, or any intermediate, smaller, or larger value. In some embodiments, the thickness 822 is calculated by subtracting the width of the elongated body 806 from a width of the internal lumen 819 and dividing the result by at least 2, for example at least 3, at least 4, or any intermediate, smaller, or larger value.

[0183] According to some exemplary embodiments, for example Figure 8D and Figure 8E As shown, the cut portion 810 is coupled to the elongated body 806 at one or more contact points along the elongated body 806. In some embodiments, the cut portion 810 is coupled to the elongated body by welding at one or more solder points (e.g., solder points 814 and 815). Alternatively, the cut portion is coupled to the elongated body by welding, gluing, crimping, and any other bonding option of metal parts.

[0184] According to some exemplary embodiments, for example Figures 8B to 8E As shown, the tissue penetrator is shaped and sized to be at least partially positioned within a biopsy tube 812, optionally a biopsy needle. In some embodiments, the tissue penetrator, such as the cutting portion 810 and the elongated body 806, extends distally from the tube 812, for example through a distal opening 813 of the tube 812. In some embodiments, for example... Figure 8C As shown, for example, when the cutting portion expands, a maximum width of the cutting portion 810 is less than or equal to an outer width 811 of the biopsy tube 812. In some embodiments, when the cutting portion expands, the maximum width of the cutting portion is greater than the width of the inner lumen of the biopsy tube.

[0185] Now for reference Figure 9A and Figure 9B It depicts a cut portion in a contracted state (e.g., a folded state) according to some exemplary embodiments of the present invention.

[0186] According to some exemplary embodiments, in a contracted state, the tissue penetrator is inserted into the inner lumen 819 of the biopsy tube 812. In some embodiments, the cutting portion 810 is folded, for example, at least partially around the elongated body 806. In some embodiments, the cutting portion 810 is flexible, for example, to allow folding in a contracted state. In some embodiments, the cutting portion 810 is irreversibly contractible, for example, the cutting portion 810 cannot return to its previous shape once it has contracted inward. Optionally, the cutting portion is also elastic, for example, to allow a return to a previous expanded state.

[0187] According to some exemplary embodiments, in a contracted state, for example Figure 9B As shown, the cutting portion contacts the inner surface of the biopsy tube lumen 819. Optionally, in a retracted state, the sharp edge of the cutting portion is located at a distance from the inner surface of the lumen 819, for example to prevent damage to the surface when the tissue penetrator moves within the lumen 819.

[0188] Now for reference Figures 10A to 10D It depicts the contraction of a curved cut portion according to some exemplary embodiments of the present invention.

[0189] According to some exemplary embodiments, for example Figure 10A As shown, a curved cutting portion 1004 is coupled to a tissue penetrator body, such as a shaft 1006. In some embodiments, in Figure 10A In the expanded state shown, the maximum width 1012 of the cutting portion 1004 is greater than a width 1014 of the internal lumen 1008 of the biopsy tube 1010, and the tissue penetrator is at least partially located within the internal lumen. In some embodiments, in an expanded state, the cutting portion extends at least partially from the internal lumen 1008.

[0190] According to some exemplary embodiments, for example Figure 10B As shown, the cutting portion 1004 is configured to contract (e.g., fold) to obtain a width 1016 smaller than the width of the inner lumen 1008. In some embodiments, the cutting portion has sufficient elasticity to bend inward, for example, to obtain a width smaller than the width of the inner lumen 1008.

[0191] Alternatively, for example Figure 10C and Figure 10DAs shown, a curved cut portion 1014 coupled to the tissue penetrator body 1016 is configured to at least partially roll up, for example, within the lumen 1008. In some embodiments, when the cut portion 1014 is at least partially rolled up, two opposing ends (e.g., opposing ends 1017 and 1015) overlap and optionally contact each other. Alternatively, the two opposing ends of the cut portion are at least partially rolled up without overlapping, for example... Figure 9B As shown.

[0192] An exemplary tissue penetrator with an integrated cutting section

[0193] Now for reference Figure 11A and Figure 11B It depicts a tissue penetrator having an integrated cutting portion according to some exemplary embodiments of the present invention.

[0194] According to some exemplary embodiments, a tissue penetrator 1102 includes a proximal segment 1104 and a distal segment 1106. In some embodiments, the tissue penetrator includes an elongated body 1107 in the proximal segment and a cutting portion 1108 in the distal segment 1106. In some embodiments, the cutting portion 1108 is integrated with the elongated body, for example, formed from the same sheet or layer of material.

[0195] According to some exemplary embodiments, the elongated body 1107 and the cutting portion 1108 are formed from a single layer of material, such as steel plate, stainless steel, alloy steel (e.g., cobalt-chromium), or superelastic alloy, shape memory alloy (e.g., nitinol). In some embodiments, the elongated body 1107 is formed by bending the layer to form a tubular shape, such as a closed tube, the shape and size of which are designed to be placed inside a biopsy tube. In some embodiments, the cutting portion is formed by cutting a tube, for example using laser cutting. In some embodiments, a portion of the elongated body is shaped and sized to be positioned inside the biopsy tube, the portion of the elongated body having a fixed width or diameter smaller than the width or diameter of the biopsy tube. Alternatively, the outer surface of the elongated body 1107 may be smooth, for example to prevent damage to the inner surface of the biopsy tube.

[0196] According to some exemplary embodiments, the cut portion is formed by bending a layer of material to create a concave shape, and optionally has a distally extending tip 1109. In some embodiments, the maximum width of the cut portion 1108 is greater than the maximum width of the elongated body 1107.

[0197] According to some exemplary embodiments, the elongated body 1107 includes a window or opening, such as opening 1111, for example to allow for reduced retraction force.

[0198] It is anticipated that many related biopsy tubes will be developed during the patent expiration period of this application; the scope of the term biopsy tube is intended to include all such prior art technologies.

[0199] As used in this article, the term “about” in relation to quantity or value means “within ±20%”.

[0200] The terms “include,” “contain,” “including,” “have,” “have,” and their variations mean “including but not limited to.”

[0201] The term "composed of" means "including and limited to".

[0202] The term "consistently made up of" means that a composition, method, or structure may include additional ingredients, steps, and / or portions, provided that the additional ingredients, steps, and / or portions do not materially alter the essential and novel features of the claimed composition, method, or structure.

[0203] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. For example, the terms “a unit” or “at least one unit” can include multiple units, including combinations thereof.

[0204] Throughout this application, various embodiments of the invention may be presented in a scope format. It should be understood that the scope format is merely for convenience and brevity and should not be construed as an inflexible limitation of the scope of the invention. Therefore, the scope description should be considered as having specifically disclosed all possible sub-scopes and the individual numerical values ​​within those scopes. For example, a description of a scope such as 1 to 6 should be considered as having specifically disclosed sub-scopes, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers within that scope, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the scope.

[0205] Whenever a range of numbers is indicated herein (e.g., “10-15”, “10 to 15”, or any pair of numbers linked by such another range indication), it is intended to include any number (fraction or integer) within the specified range limit, including the range limit, unless the context explicitly states otherwise. The phrase “range / range / range between” where the first indicates a number and the second indicates a number, and “range / range / range from” where the first indicates a number “to,” “until,” “until,” or “through” (or another such range indication term) and the second indicates a number, are used interchangeably herein and mean to include the first and second indicated numbers as well as all decimals and integers between them.

[0206] Unless otherwise stated, the numbers used herein and any ranges of numbers based thereon are approximations within a reasonable range of measurement precision and rounding error as understood by those skilled in the art.

[0207] It should be understood that, for clarity, certain features of the invention described in the context of a single embodiment may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination or in embodiments suitable for any other description of the invention. Certain features described in the context of various embodiments should not be considered as essential features of those embodiments unless the embodiments are invalid without these elements.

[0208] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0209] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated herein by reference. Furthermore, any reference or designation of any reference in this application should not be construed as an admission that such reference is prior art to the invention. The use of section headings should not be construed as necessarily limiting. Additionally, any priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. A biopsy assembly, comprising: A biopsy tube having a lumen; A tissue penetrator having a distal tip shaped to penetrate tissue, wherein the tissue penetrator is located within the lumen and comprises: A slender, flexible body whose shape and size can move within the cavity; A retractable distal cutting portion, connected to the elongated flexible body and located at the front end of the biopsy tube, extends from the lumen in an expanded state, and is configured to retract to a width less than an internal width of the lumen in a retracted state, wherein the retractable distal cutting portion includes a distal sharp cutting edge configured to make a thin incision through the tissue, wherein in the expanded state, a maximum width of the retractable distal cutting portion is greater than the internal width or an internal diameter of the lumen; The retractable distal cut portion is coupled to a distal end of the elongated flexible body; and The distal tip is an integrated part of the retractable distal cut portion.

2. The biopsy assembly as described in claim 1, characterized in that: The retractable distal cut portion is formed of a thin and flexible material layer coupled to the slender flexible body.

3. The biopsy assembly as described in claim 2, characterized in that: The distal sharp cutting edge is located on one side of the retractable distal cutting portion facing the tissue surface, wherein when the retractable distal cutting portion extends out of the lumen and is in the expanded state, it is configured to perform the thin incision through the tissue as the tissue penetrator advances into the tissue.

4. The biopsy assembly as described in claim 2, characterized in that: In the contracted state, the tissue penetrator is configured to retract into the lumen of the biopsy tube.

5. The biopsy assembly as described in claim 1, characterized in that: The retractable distal cutting section is integrated with the slender flexible body.

6. The biopsy assembly as claimed in claim 1, characterized in that: The retractable distal cutting portion is at least partially flexible.

7. The biopsy assembly as described in claim 2, characterized in that: The retractable distal cut is thin, and the ratio of the thickness of the retractable distal cut to the maximum width or diameter of the retractable distal cut is greater than 1:

8.

8. The biopsy assembly as claimed in claim 1, characterized in that: The thickness of the distal sharp cut edge is less than 0.1 mm.

9. The biopsy assembly as described in claim 3, characterized in that: The tissue-facing surface of the retractable distal cut is at least partially angled or at least partially curved, wherein the retractable distal cut includes the distal sharp cut edge.

10. The biopsy assembly as claimed in claim 9, characterized in that: The angle between the surface and the tissue is greater than 20 degrees.

11. The biopsy assembly as claimed in claim 2, characterized in that: The side surface of the retractable distal cut is curved.

12. The biopsy assembly as claimed in claim 2, characterized in that: In the expanded state, a cross section of a circumference of the retractable distal cut portion is a continuous arc.

13. The biopsy assembly as claimed in claim 12, characterized in that: The arc is directed at an angle of at least 30 degrees.

14. The biopsy assembly as claimed in claim 12, characterized in that: The radius of curvature of the arc is in the range of 0.2 to 20 millimeters.

15. The biopsy assembly as claimed in claim 12, characterized in that: In the expanded state, one length of the arc reaches 30 millimeters.

16. The biopsy assembly as claimed in claim 1, characterized in that: In the expanded state, an angle greater than 20 degrees is formed between a surface of the retractable distal cut portion facing the biopsy tube and the biopsy tube.

17. The biopsy assembly of claim 1, further comprising: A coupler configured to reversibly couple the elongated, flexible body of the tissue penetrator to the biopsy tube.

18. The biopsy assembly as claimed in claim 17, characterized in that: The coupler is configured to fix the tissue penetrator in a position relative to the biopsy tube in an axial direction.

19. The biopsy assembly as claimed in claim 1, characterized in that: The retractable distal cut portion is formed of a single thin and flexible material layer configured to bend around the elongated flexible body to a width smaller than the internal width of the lumen.

20. The biopsy assembly as claimed in claim 1, characterized in that: The retractable distal cut portion is formed of a thin and flexible material layer configured to be rolled up at least partially around the elongated flexible body to a width smaller than the internal width of the lumen.

21. The biopsy assembly as claimed in claim 1, characterized in that: The projection of the retractable distal cutting portion is a triangle.

22. The biopsy assembly as claimed in claim 1, characterized in that: One outer surface of the retractable distal cutting portion is smooth.

23. The biopsy assembly as claimed in claim 2, characterized in that: The retractable distal cutting section is rigid in one axial direction and flexible in one lateral direction and / or all lateral directions.

24. The biopsy assembly as claimed in claim 2, characterized in that: A minimum thickness of one wall of the biopsy tube surrounding the lumen is at least 10% of the inner diameter of the biopsy tube.

25. The biopsy assembly as claimed in claim 2, characterized in that: The minimum thickness of one wall of the biopsy tube is 0.05 mm.

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