Tissue penetrator

Abstract

1. A biopsy assembly comprising: a biopsy tube defining a lumen; and a tissue penetrator having a distal tip shaped to penetrate tissue, the tissue penetrator comprising: a flexible elongate body shaped and sized to be disposed within the lumen and to travel within the biopsy tube lumen; and a foldable distal cutting portion coupled to the body and extending out of said lumen in an expanded state and configured to fold to a width less than an inner width of the lumen in a collapsed state, the foldable distal cutting portion comprising a sharp distal cutting edge configured to perform a thin cut through tissue, wherein in the expanded state, the cutting portion has a maximum width greater than an inner width or diameter of the biopsy tube lumen.

Description

Technical Field

[0001] [Related Applications] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 046,711, filed on July 1, 2020, the contents of which are hereby incorporated by reference in their entirety.

Background Art

[0002] In some embodiments, the present invention relates to a tissue penetrator, and more particularly, but not limited to, a tissue penetrator of a biopsy device.

Summary of the Invention

Means for Solving the Problems

[0003] Some examples of some embodiments of the present invention are listed below. Features from one example can be combined with features from another example.

[0004] Example 1. A biopsy tube defining a lumen, and a tissue penetrator having a distal tip shaped to penetrate tissue, comprising the tissue penetrator is disposed within the lumen, a flexible, elongated body shaped and sized to move within the lumen of the biopsy tube, and a foldable distal cutting portion coupled to the body, extending outwardly from the lumen in an extended state, and configured to be folded to a width smaller than the inner width of the lumen in a folded state, the foldable distal cutting portion having a sharp distal cutting edge configured to perform a thin cut through the tissue, and in the extended state, the maximum width of the cutting portion is greater than the inner width or inner diameter of the lumen of the biopsy tube, a foldable distal cutting portion.

[0005] Example 2. The biopsy assembly according to Example 1, wherein the distal tip extends distally to the foldable distal cutting portion and is integrated with the elongated body.

[0006] Example 3. The biopsy assembly according to Example 1, wherein the distal tip portion is integrated with a foldable distal cutting portion.

[0007] Example 4. The biopsy assembly according to any one of Examples 1 to 3, wherein the foldable distal cutting portion is at least partially flexible.

[0008] Example 5. The biopsy assembly according to any one of Examples 1 to 4, wherein the foldable distal cutting portion is thin and the ratio between the thickness of the cutting portion and the maximum width or diameter thereof is greater than 1:8.

[0009] Example 6. The biopsy assembly according to any one of Examples 1 to 5, wherein the thickness of the cutting edge is less than 0.1 mm.

[0010] Example 7. The surface of the foldable tissue penetrator having a distal cutting edge facing the tissue is at least partially angled or at least partially curved, according to any one of Examples 1 to 6.

[0011] Example 8. The biopsy assembly according to Example 7, wherein the angle between the surface and the tissue is greater than 20 degrees.

[0012] Example 9. The biopsy assembly according to any one of Examples 1 to 8, wherein the side surface of the foldable tissue penetrator is curved.

[0013] Example 10. The biopsy assembly according to any one of Examples 1 to 9, wherein the cross-section of the circumference of the cutting portion facing the tissue is a continuous arc in the expanded state.

[0014] Example 11. The biopsy assembly according to Example 10, wherein the arc forms an angle of at least 30 degrees.

[0015] Example 12. The biopsy assembly according to Example 10 or 11, wherein the radius of curvature of the arc is in the range of 0.2 to 20 mm.

[0016] Example 13. The biopsy assembly according to any one of Examples 10 to 12, wherein the length of the arc in the expanded state is up to 30 mm.

[0017] Example 14. The biopsy assembly according to any one of Examples 1 to 13, wherein the angle between the surface of the cutting portion facing the biopsy tube in the expanded state and the biopsy tube is greater than 20 degrees.

[0018] Example 15. The biopsy assembly according to any one of Examples 1 to 14, comprising a coupler configured to reversibly couple the flexible elongated body of the tissue penetrator to the biopsy tube.

[0019] Example 16. The biopsy assembly according to Example 15, wherein the coupler is configured to axially fix the position of the tissue penetrator relative to the biopsy tube.

[0020] Example 17. The biopsy assembly according to any one of Examples 1 to 16, wherein the foldable cutting portion is formed from a single thin flexible layer of material configured to bend around the flexible elongated body to a width smaller than the inner width of the lumen.

[0021] Example 18. The biopsy assembly according to any one of Examples 1 to 17, wherein the foldable cutting portion is formed from a thin flexible layer of material configured to at least partially wrap around the flexible elongated body to a width smaller than the inner width of the lumen.

[0022] Example 19. The biopsy assembly according to any one of Examples 1 to 18, wherein the protrusion of the foldable cutting portion is shaped as a triangle.

[0023] Example 20. The biopsy assembly according to any one of Examples 1 to 19, wherein the outer surface of the foldable distal cutting portion is smooth.

[0024] Example 21. The biopsy assembly according to any one of Examples 1 to 20, wherein the foldable distal cutting portion is axially rigid and bendable in the transverse and / or tangential directions.

[0025] Example 22. The biopsy assembly according to any one of Examples 1 to 21, wherein the minimum thickness of the wall of the biopsy tube surrounding the lumen is at least 10% of the inner diameter of the biopsy tube.

[0026] Example 23. The biopsy assembly according to any one of Examples 1 to 22, wherein the minimum thickness of the wall of the biopsy tube is 0.05 mm.

[0027] Example 24. Advancing a tissue penetrator having a foldable cutting portion through a tissue wall disposed between the biopsy tube and a target tissue to be sampled, forming a thin cut through the tissue wall with the foldable cutting portion, and folding the foldable cutting portion into the lumen of the biopsy tube, the tissue penetration method comprising:

[0028] Example 25. The tissue penetration method according to Example 24, comprising sampling the target tissue by advancing the biopsy tube into the target tissue.

[0029] Example 26. The tissue penetration method according to Example 25, wherein sampling comprises sampling the tissue by the target while rotating the biopsy tube while advancing it into the target tissue.

[0030] Example 27. The tissue penetration method according to any one of Examples 24 to 26, wherein the thin cut is a cut having a ratio of thickness to length greater than 1:10.

[0031] Example 28. The tissue penetration method according to any one of Examples 24 to 27, wherein forming comprises forming a thin straight cut with the foldable cutting portion within the tissue wall.

[0032] Example 29. The tissue penetration method according to Example 28, wherein the tissue wall comprises an intestinal tissue wall or a duodenal tissue wall.

[0033] Example 30. The tissue penetration method according to any one of Examples 24 to 27, wherein forming includes forming a thin, curved cut in the tissue wall.

[0034] Example 31. The tissue penetration method according to Example 30, wherein the tissue wall includes the wall of the stomach.

[0035] Example 32. The tissue penetration method according to Example 28 or 29, wherein the radius of curvature of the thin cut is in the range of 0.2 to 20 mm.

[0036] Example 33. The tissue penetration method according to any one of claims 24 to 32, wherein folding includes retracting the tissue penetrator through the lumen of the biopsy tube.

[0037] Example 34. The tissue penetration method according to any one of Examples 24 to 33, wherein folding includes at least partially wrapping a foldable cutting portion.

[0038] Example 35. The tissue penetration method according to any one of Examples 24 to 34, wherein folding includes reversibly folding a foldable cutting portion.

[0039] Example 36. The tissue penetration method according to any one of Examples 24 to 35, wherein the tissue penetrator is at least partially removed from the lumen of the biopsy tube before sampling.

[0040] Example 37. The tissue penetration method according to any one of Examples 24 to 36, wherein folding includes folding a foldable cutting portion into the lumen of the biopsy tube without tissue sampling.

[0041] Example 38. The tissue penetration method according to any one of Examples 24 to 37, wherein the tissue wall includes the bronchial airway wall or the tracheal wall.

[0042] Example 39. The tissue penetration method according to any one of Examples 24 to 38, wherein the tissue wall includes the wall of the digestive tract and the esophageal wall.

[0043] 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 belongs. In the practice or testing of embodiments of the present invention, methods and materials similar or equivalent to those described herein can be used, but exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting necessarily.

Brief Description of the Drawings

[0044] Some embodiments of the present invention are described by way of illustration only with reference to the accompanying drawings. Referring now to the drawings in detail, it is emphasized that the specific matters shown are illustrative and for the purpose of describing embodiments of the present invention. In this regard, the description using the drawings will clarify to those skilled in the art how embodiments of the present invention can be implemented.

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[0045] In some embodiments of the present invention, it relates to a tissue penetrator, and more particularly, but not limited to, a tissue penetrator of a biopsy device.

[0046] One aspect of some embodiments relates to folding at least a portion of a tissue penetrator, such as a stylet, before a biopsy is performed. In some embodiments, the cutting portion of the tissue penetrator is folded onto a sampling tube, such as a sampling needle, before the biopsy is performed. As used herein, a sampling tube refers to a biopsy tube and a sampling needle refers to a biopsy needle. In some embodiments, the cutting portion is folded into the inner lumen of the sampling tube, for example, to enable removal of the tissue penetrator from the body.

[0047] According to some embodiments, the cutting portion is folded into the sampling tube, for example, when the sampling tube reaches the desired target tissue in the body that needs to be sampled. In some embodiments, the cutting portion is folded when the sampling tube is in proximity, for example, at a distance less than 2 mm, such as less than 1 mm, less than 0.5 mm, or any intermediate, smaller, or larger value from the desired target tissue. Alternatively, the cutting portion is folded when the sampling tube is in contact with the desired target tissue.

[0048] According to some embodiments, in the expanded state, the cut portion is wider than the opening of the sampling tube. In some embodiments, the width of the cut portion in the folded state is smaller than the minimum width of the sampling tube, such as the minimum inner diameter. In some embodiments, in the expanded state, the width of the cut portion is the same as or smaller than the outer diameter or the maximum width of the sampling tube. In some embodiments, in the expanded state, the maximum width of the cut portion, e.g., the maximum distance between two points on the cut portion, is within the range between half of the circumference around the sampling tube and the diameter of the sampling tube.

[0049] According to some embodiments, the cut portion, e.g., the foldable cut portion, is axially rigid, e.g., to enable it to penetrate a tissue wall or membrane without being folded. Further, the cut portion is bendable in the lateral and / or tangential directions, e.g., to enable it to be folded, e.g., bent, within a tube, e.g., a biopsy tube. In some embodiments, the tissue wall includes a gastric wall, a duodenal wall, an intestinal wall, a bronchial wall, a bronchiolar airway wall, a blood vessel wall, a GI tract wall, an esophageal wall, an epithelial layer, skin, a diaphragm, a pleura, a heart wall, and / or a heart septum.

[0050] According to some embodiments, in the expanded state, the cut portion is straight, e.g., when penetrating a tissue wall having lower self-sealing properties, e.g., an intestinal wall or a duodenal wall, and thus, a straight cut is formed to minimize leakage through the formed cut. Alternatively, in the expanded state, the cut portion is curved, e.g., when penetrating a tissue wall having high self-sealing properties, e.g., a gastric wall, and thus, the curved cut is formed to maximize the ease of penetrating the tissue wall. Optionally, the tissue wall is a thick tissue wall having a thickness greater than 1 mm, e.g., greater than 2 mm, greater than 3 mm, or any intermediate value, smaller than, or larger than a value.

[0051] A potential advantage of creating a cut in tissue that has a maximum distance between two points on the cut within a maximum extent, e.g., in the range between half the circumference of the sampling tube and the sampling tube diameter, is that it may allow for easier penetration of the sampling tube through walls, such as the gastric wall, intestinal wall, and / or duodenal wall, while preventing leakage through the formed cut.

[0052] One aspect of some embodiments relates to removing a wide tissue penetrator from target tissue through a narrow opening of a biopsy tube lumen. In some embodiments, at least a portion of the wide tissue penetrator, e.g., the cut portion, is reformed to enter through the opening. In some embodiments, at least a portion of the tissue penetrator is folded to a width smaller than a minimum width, e.g., the inner diameter of the biopsy tube opening. Optionally, at least a portion of the tissue penetrator is reversibly folded to enter through the biopsy tube lumen opening. In some embodiments, at least a portion of the tissue penetrator is folded within the biopsy tube lumen without sampling the tissue.

[0053] According to some embodiments, at least a portion of the tissue penetrator is folded to enter through the opening and into the biopsy tube lumen. In some embodiments, at least a portion of the tissue penetrator is at least partially furled or at least partially wound to obtain a shape having a cross-section narrower than the biopsy tube lumen opening. In some embodiments, when the cut portion is furled, two or more ends of the cut portion overlap.

[0054] According to some embodiments, the cutting portion of the tissue penetrator is reshaped by applying an external force to the tissue penetrator, for example, by retracting the tissue penetrator through, for example, a biopsy tube lumen. Alternatively, the cutting portion is reshaped by rotating the tissue penetrator at least 30 degrees, for example, at least 90 degrees, 180 degrees, 360 degrees, or any intermediate, smaller or larger degree of rotation. In some embodiments, the cutting portion is reshaped by a force applied to the cutting portion by the biopsy tube body, causing the cutting portion to be reshaped.

[0055] According to some embodiments, the tissue penetrator is used in the biopsy sampling process of tissue, such as tissue suspected of being malignant tissue.

[0056] According to some embodiments, the endoscope is navigated towards the target tissue that needs to be sampled. In some embodiments, when reaching the tissue wall, such as the tissue wall surrounding the target tissue, the tissue penetrator is extended through the distal opening of the endoscope. In some embodiments, the extension of the tissue penetrator includes the extension of the cutting portion of the tissue penetrator.

[0057] According to some embodiments, when reaching the desired target tissue through the tissue wall of the desired target or any tissue wall, the tissue penetrator advances distally to the endoscope and through the tissue wall. In some embodiments, the cutting portion of the tissue penetrator forms a cut in the tissue wall, for example, by advancing through the tissue wall. In some embodiments, the cutting portion of the tissue penetrator advances 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 from the tissue wall cut.

[0058] According to some embodiments, the tissue penetrator is part of a biopsy assembly that includes a biopsy tube. In some embodiments, when the endoscope reaches the tissue wall, a biopsy assembly having an expanded cutting portion extending from the distal end of the biopsy tube advances through the tissue wall. In some embodiments, when the biopsy assembly penetrates the tissue wall and optionally at least partially penetrates the target tissue, the tissue penetrator blocks the lumen of the biopsy tube and prevents tissue from penetrating into the biopsy tube.

[0059] According to some embodiments, after forming a cut in the tissue wall, the tissue penetrator is retracted into the inner lumen of the biopsy tube, for example, to unblock the inner 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 while rotating within the target tissue, as described, for example, in WO2019155472A1. In some embodiments, tissue sampling includes one or more advances of the biopsy tube into the target tissue, for example, 2, 3, 4, or any number of times.

[0060] According to some embodiments, the advancement of at least one of the tissue penetrator, the biopsy tube, and / or the biopsy assembly, for example, the degree of advancement, is controlled by the handle or control unit of the biopsy device, as described, for example, in WO2019155472A1.

[0061] According to some embodiments, the tissue wall includes muscle or any type of tissue located between the biopsy tube, or any type of tube inserted into the body, and the desired target tissue. A potential advantage of the tissue penetrator may be to enable penetration of the tissue wall with minimal or minimal sampling of the tissue wall, for example, less than 10%, less than 5%, less than 1% of the volume of the tissue wall compared to the volume of the sampled target tissue.

[0062] The embodiments provided in this application describe the use of a tissue penetrator having a biopsy tube, but it should be understood that the tissue penetrator can be used with any tube inserted into the body, such as a drainage tube, a nutrition tube, a guide tube, an insertion tube, a drainage, a dilator, a catheter, an injection needle, or any type of needle not used for injection, such as a suction needle.

[0063] Before detailing at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited to the details of the construction and arrangement of the components and / or methods shown in the following description and / or drawings and / or examples in its application. The present invention can have other embodiments or can be implemented or executed in various ways.

[0064] Exemplary tissue cutting process According to some exemplary embodiments, during a biopsy sampling process, a biopsy needle having an external distal cutting portion used to penetrate a biopsy tube, such as a tissue wall, such as a septum, is directed towards the desired target tissue to be sampled. In some embodiments, a cut in the tissue wall located between the target tissue to be sampled and the biopsy tube is formed by a tissue penetrator to enable easy penetration of the sampling tube into the target tissue. In some embodiments, the cut has a width that is at least as wide as the outer width of the biopsy needle and less than half the outer circumference of the biopsy tube. Next, referring to FIG. 1, a process for tissue cutting by a foldable cutting portion according to some exemplary embodiments of the present invention will be described.

[0065] According to some exemplary embodiments, a tissue penetrator having a foldable cutting portion is advanced through tissue at block 102. In some embodiments, the tissue penetrator is coupled to a biopsy tube, such as a biopsy needle. In some embodiments, at least a portion of the tissue penetrator is disposed within the inner lumen of the biopsy tube, while the foldable cutting portion of the tissue penetrator extends outside the biopsy tube. Optionally, the foldable cutting portion extends through the distal opening of the biopsy tube, such as the opening facing the tissue.

[0066] According to some exemplary embodiments, the tissue penetrator is fixed to the biopsy tube when advancing through tissue, such as at block 102. In some embodiments, the tissue penetrator is axially fixed to the biopsy tube. Additionally, the biopsy tube, such as a rotating biopsy needle, rotates relative to the tissue penetrator. Alternatively, the tissue penetrator rotates with the biopsy tube.

[0067] According to some exemplary embodiments, the tissue penetrator forms a thin cut through the tissue at block 104. In some embodiments, the thin cut is formed, for example, by the foldable cutting portion of the tissue penetrator during advancement of the tissue penetrator at 102. In some embodiments, the cut formed by the foldable cutting portion has a width equal to or less than the maximum width of the biopsy tube. In some embodiments, the cut formed by the foldable cutting portion has a length equal to or less than the maximum width of the biopsy tube. In some embodiments, the cut formed by the foldable cutting portion has a length equal to or less than half or the circumferential length of the biopsy tube.

[0068] According to some exemplary embodiments, a thin cut is formed in a tissue wall, such as a stomach wall, a duodenal wall, an intestinal wall, and / or a bronchial airway wall. In some embodiments, the tissue wall is elastic. In some embodiments, the thin cut formed in the tissue wall allows for penetration of a biopsy tube with a minimal application of force to the tissue, for example, while preventing or restricting leakage of fluid through the formed thin cut. Optionally, the thin cut allows for improved self-sealing of the tissue wall after removal of the biopsy tube from the body, for example.

[0069] According to some exemplary embodiments, a foldable cutting portion is linear, such as planar, in an expanded state. In some embodiments, the straight foldable cutting portion is used to form a straight cut, for example, when a tissue penetrator penetrates a tissue wall having limited self-sealing properties, such as a duodenal wall, an intestinal wall, a bronchial wall, a bronchial airway wall, a blood vessel wall, a GI tract wall, an esophageal wall, or any wall of an anatomical tube. Alternatively, the foldable cutting portion is curved in the expanded state. In some embodiments, the curved foldable cutting portion is used to form a curved cut, for example, when penetrating a tissue wall having better self-sealing properties, such as a stomach wall, or a tissue or organ, such as an epithelial layer, skin, diaphragm, pleura, heart wall, and / or any anatomical septum tissue, membrane, or tissue layer that at least partially surrounds a heart septum.

[0070] According to some exemplary embodiments, the thickness of the cut formed by the foldable cutting portion is less than the maximum width or outer diameter of the biopsy tube.

[0071] According to some exemplary embodiments, the foldable cutting portion of the tissue penetrator is reshaped, for example, folded at block 106. In some embodiments, at least a portion of the foldable cutting portion is folded at block 106. In some embodiments, the foldable cutting portion is folded to obtain a width smaller than the minimum width of the inner lumen of the biopsy tube. In some embodiments, the cutting portion is folded when reaching the target tissue that needs to be sampled. Alternatively, the cutting portion is folded when reaching a distance less than 5 mm, for example, less than 3 mm, less than 1 mm, less than 0.5 mm, or any intermediate, smaller, or larger distance from the target tissue that needs to be sampled.

[0072] According to some exemplary embodiments, the foldable cutting portion is folded 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 foldable cutting portion is folded by applying a force to the sampling tube, for example, by pushing, retracting, and / or rotating the sampling tube relative to the tissue penetrator.

[0073] According to some exemplary embodiments, the tissue penetrator is removed from the tissue at block 108. In some embodiments, when the folding portion is folded 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 enable insertion of a tissue sample into the inner lumen of the biopsy tube. In some embodiments, the tissue penetrator is within the inner lumen of the biopsy tube and has a desired volume within the inner lumen of the biopsy tube, for example, at least 1 mm 3 for example, at least 3 mm 3 at least 5 mm 3, at least 1 cm 3 and can be retracted to a volume of at least 1 cm, or any intermediate, smaller, or larger volume within the inner lumen of the biopsy tube, for example, a distance that allows entry into the removed volume of the tissue sample.

[0074] State of exemplary cutting portion According to some exemplary embodiments, the cutting portion of the tissue penetrator moves between an expanded state and a folded state. In some embodiments, the folded state is irreversible, for example, preventing reuse of the cutting portion. Alternatively, the folded state is reversible and allows it to return to the expanded state. In some embodiments, in the folded state, the maximum width of the cutting portion is, for example, smaller than the minimum width of the inner lumen of the biopsy tube to allow removal of the tissue penetrator from the tissue passing through the inner lumen of the biopsy tube. Refer to FIG. 2A showing the transition between the expanded state and the folded state of the cutting portion of the tissue penetrator according to some exemplary embodiments of the present invention.

[0075] According to some exemplary embodiments, in the expanded state 202, at least a portion of the cutting portion of the tissue penetrator is expanded. In some embodiments, the cutting portion extends out from the opening of the inner lumen of the biopsy tube. In some embodiments, the cutting portion extends to and faces the tissue located in the forward path of the tissue penetrator. In some embodiments, in the expanded state, the maximum width of the cutting portion is greater than or similar to the maximum outer width of the biopsy tube, for example, the maximum outer diameter.

[0076] According to some exemplary embodiments, in the reshaped state, for example, the folded state 204, at least a portion of the tissue penetrator, for example, at least a portion of the cutting portion, is folded. In some embodiments, at least a portion of the cutting portion is folded to obtain a maximum width that is smaller than the minimum width of the inner lumen of the biopsy tube. In some embodiments, in the folded state, the tissue penetrator is shaped and sized to be moved within the inner lumen of the biopsy tube.

[0077] According to some exemplary embodiments, the cutting portion of the tissue penetrator is reversibly movable between the expanded state 202 and the folded state. Alternatively, the cutting portion moves irreversibly to the folded state. In some embodiments, the cutting portion of the tissue penetrator moves between the expanded state 202 and the folded state 204 by axially moving one or both or a portion of the biopsy tube and the tissue penetrator relative to each other. Alternatively or additionally, the cutting portion of the tissue penetrator moves between the expanded state 202 and the folded state 204 by rotating one or both of the biopsy tube and the tissue penetrator or a portion thereof relative to each other.

[0078] Exemplary cut According to some exemplary embodiments, a tissue penetrator, e.g., a foldable cutting portion of the tissue penetrator, is configured to make a cut through the tissue. In some embodiments, the cutting edge of the foldable cutting portion is shaped and sized to make a cut through a tissue wall surrounding a region of tissue, e.g., through a tissue layer. In some embodiments, the tissue layer is an elastic tissue layer. For example, a tube, e.g., a sampling tube, and a tissue layer disposed between the target tissue to be sampled. In some embodiments, the tissue wall includes an abdominal wall, a gastric wall, a duodenal wall, an intestinal wall, a bronchial airway wall, a blood vessel wall, a GI tract wall, an esophageal wall, or any wall of an anatomical tube.

[0079] Reference is now made to FIGS. 2B and 2C, which show the formation of a straight cut through a tissue, e.g., a tissue wall, according to some exemplary embodiments of the present invention.

[0080] According to some exemplary embodiments, the sharp cutting edge of the foldable cutting portion of the tissue penetrator is configured to form a thin straight cut through the tissue, such as a straight cut 210. In some embodiments, the length 214 of the straight cut 210 ranges from 2 to 30 mm, such as 2 to 8 mm, 5 to 10 mm, 8 to 15 mm, 13 to 20 mm, or any intermediate, shorter, or longer cut. In some embodiments, the length 214 of the straight cut is equal to or greater than the diameter 216 of the tube 212, such as a biopsy tube, that needs to be penetrated by the straight cut. In some embodiments, the length of the cut 214 is selected according to the type of tissue and / or the diameter of the tube. For example, on the one hand, it is long enough to allow penetration of the tube without applying a high level of force to the tube, enabling ease of adaptation, without a high level of stress on the tissue that may cause tissue rupture, and / or on the other hand, it is long enough to prevent leakage through the cut, for example, when the tube is removed from the tissue.

[0081] In some embodiments, the thickness of the straight cut 210, for example, the distance between two opposing edges of the straight cut, is less than 0.5 mm, such as 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 between the maximum width 214 of the straight cut 210, for example, the maximum distance between two points on the cut, and the thickness of the straight cut is greater than 5:1, such as greater than 10:1, greater than 15:1, greater than 20:1, greater than 100:1, or any intermediate smaller or higher ratio. In some embodiments, the cutting edge of the foldable cutting portion of the tissue penetrator forms a straight cut of the tissue wall that is less elastic and / or has low self-sealing properties, such as the intestinal tissue wall or the duodenal tissue wall.

[0082] Now, refer to FIG. 2D, which shows the formation of a curved cut through a tissue, such as a tissue wall, according to some exemplary embodiments of the present invention.

[0083] According to some exemplary embodiments, the sharp cutting edge of the foldable cutting portion of the tissue penetrator is configured to form a thin curved cut, such as an arcuate cut through the tissue, such as curved cut 220. In some embodiments, the length of the curved cut 220 ranges from 0.5 to 30 mm, such as 1 to 8 mm, 5 to 10 mm, 8 to 15 mm, 13 to 20 mm, or any intermediate, shorter, or longer cut. In some embodiments, the maximum width of the curved cut, such as the maximum distance between two positions on the curved cut, is greater than the diameter 228 of the tube 222, such as a biopsy tube, that needs to pass through the curved cut, as shown, for example, in FIG. 2D.

[0084] According to some exemplary embodiments, the radius of curvature of the curved cut ranges from 0.2 to 20 mm, such as 0.2 to 8 mm, 5 to 10 mm, 7 to 15 mm, 10 to 20 mm, or any intermediate, smaller, or larger value range. In some embodiments, the curvature diameter of the curved cut 220 is at least the outer diameter 228 of the tube, such as the tube 222 that needs to pass through the cut 220. In some embodiments, the length and / or radius of curvature of the cut 220 is selected according to the type of tissue and / or the elasticity of the tissue, and / or the diameter of the tube, for example, enabling the penetration of the tube without applying a high level of force to the tissue and / or tube that may cause tissue rupture, and / or preventing leakage through the cut when the tube is removed from the tissue.

[0085] In some embodiments, the thickness, e.g., the distance between two opposing edges of the curved cut 220, is less than 0.5 mm, e.g., less than 0.4 mm, less than 0.2 mm, less than 0.1 mm, less than 0.01 mm, or any intermediate value, smaller value or larger value. In some embodiments, the ratio between the length or maximum width of the curved cut 220 and the thickness of the curved cut is greater than 5:1, e.g., greater than 10:1, greater than 15:1, greater than 20:1, greater than 100:1, or any intermediate, smaller or higher ratio. In some embodiments, the cutting edge of the foldable cutting portion of the tissue penetrator forms a curved cut in a tissue wall, e.g., a gastric tissue wall, that is elastic and / or has high self-sealing properties.

[0086] Exemplary tissue sampling process According to some exemplary embodiments, a biopsy tube, e.g., a biopsy needle, is advanced through body tissue to reach a desired target tissue that needs to be sampled, either directly or through a tissue wall. In some embodiments, the tissue penetrator is coupled, e.g., reversibly coupled, to the biopsy tube to enable easy penetration of the tissue during advancement of the biopsy tube. In some embodiments, at least a portion of the tissue penetrator, e.g., the cutting portion of the tissue penetrator, is positioned in front of the biopsy tube and faces the tissue.

[0087] According to some exemplary embodiments, the cutting portion of the tissue penetrator is shaped and sized to penetrate the tissue while forming a cut that is wider than the maximum width of the biopsy tube following the tissue penetrator. Additionally, the cut formed by the cut has a thickness of less than 2 mm, e.g., less than 1 mm, less than 0.1 mm, or any intermediate, smaller, or larger value.

[0088] According to some exemplary embodiments, when a cut is formed, the tissue penetrator is removed from the tissue, for example, through the lumen of a sampling tube. Referring now to FIG. 3, which shows a tissue sampling process using a tissue penetrator according to some exemplary embodiments of the present invention.

[0089] According to some exemplary embodiments, a tissue penetrator coupled to a biopsy tube, such as a biopsy needle, is provided at block 302. In some embodiments, an assembly, such as a biopsy assembly, or a kit including a tissue penetrator and a biopsy tube is provided at block 302. In some embodiments, the tissue penetrator is disposed within the inner lumen of the biopsy tube. Additionally, at least a portion of the tissue penetrator, such as the cutting portion of the tissue penetrator, extends out of the biopsy tube and is disposed distal to the biopsy tube. In some embodiments, the cutting portion extends through the distal opening of the inner lumen of the biopsy tube and faces the tissue.

[0090] According to some exemplary embodiments, the biopsy assembly is advanced at block 304 through body tissue toward the 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 under visualization from outside the body using, for example, an imaging system, such as ultrasound, x-ray, or any other imaging system.

[0091] According to some exemplary embodiments, the biopsy assembly reaches the desired target region at block 306. In some embodiments, the biopsy device reaches a desired distance from the target region at block 306, such as up to 10 cm, up to 5 cm, up to 2 cm, or any intermediate, smaller, or larger distance from the target region.

[0092] According to some exemplary embodiments, the tissue penetrator is retracted at block 308. In some embodiments, retraction of the tissue penetrator disengages the tissue penetrator from the biopsy tube and, optionally, holds the biopsy tube in place simultaneously. In some embodiments, the tissue penetrator is retracted axially relative to the biopsy tube.

[0093] According to some exemplary embodiments, at least a portion of the cut portion is reformed at block 310, for example, folded, furled, and / or wound. In some embodiments, the reformed cut portion is inserted into the inner lumen of the biopsy tube at block 310. In some embodiments, retraction and / or rotation of the tissue penetrator induces reformation, e.g., folding, of the cutting edge of the tissue penetrator. In some embodiments, during reformation, the cutting edge acquires a shape and / or size that, for example, enables insertion of the reformed cutting edge into the inner lumen of the biopsy tube. In some embodiments, in the reformed state, the maximum width or maximum diameter of the cut portion is smaller than the minimum width or minimum diameter of the inner lumen of the biopsy tube. In some embodiments, reformation of the cut portion and insertion of the cut portion into the inner lumen of the biopsy tube are performed simultaneously. Alternatively, reformation of the cut portion and insertion of the cut portion into the inner lumen of the biopsy tube are performed sequentially, for example, by applying forces in different directions and / or at two separate times.

[0094] According to some exemplary embodiments, the tissue penetrator is removed from the inner lumen of the biopsy tube, e.g., biopsy needle, at block 312. In some embodiments, the tissue penetrator is removed from the inner lumen, for example, to enable entry of a tissue sample into the inner lumen. In some embodiments, the tissue penetrator is removed by retraction of the tissue penetrator within the inner lumen.

[0095] According to some exemplary embodiments, the tissue penetrator is completely removed from the inner lumen of the sampling tube and optionally removed outside the body. Alternatively, the tissue penetrator is partially removed, for example, to drain a predetermined volume of the inner lumen of the biopsy tube. In some embodiments, draining a predetermined volume enables, for example, sampling a predetermined tissue sample volume.

[0096] According to some exemplary embodiments, body tissue is sampled at block 314. In some embodiments, during body tissue sampling, the biopsy tube, for example, 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. In some embodiments, for example during advancement of the biopsy tube by rotation of the biopsy tube, the tissue sample enters the volume of the inner lumen of the biopsy tube, such as the volume drained at block 312 by removal of the tissue penetrator.

[0097] Exemplary Tissue Penetrator and Biopsy Assembly Reference is now made to FIGS. 4A and 4B, which show a biopsy assembly comprising a biopsy tube and a tissue penetrator, according to some exemplary embodiments of the present invention.

[0098] According to some exemplary embodiments, a biopsy assembly, such as assembly 400, comprises 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, at least a portion of the tissue penetrator is disposed within the inner lumen 406 of the biopsy tube 404, as shown, for example, in FIGS. 4A and 4B.

[0099] According to some exemplary embodiments, a tissue penetrator, such as tissue penetrator 402, comprises an elongated body 408 and a cutting portion 410 located in a distal section of the elongated body, e.g., a section closer to body tissue. Optionally, the cutting portion is located at the distal end of the elongated body, e.g., the end of the elongated body closer to body tissue. Optionally, the tissue penetrator comprises a tip 412, e.g., a conical tip. In some embodiments, the tip 412 is at least partially inclined. In some embodiments, the tip 412 is shaped and sized, for example, to enable easy penetration through body tissue as the tissue penetrator advances through the body tissue. In some embodiments, the tip 412 is part of the cutting portion 410. Alternatively, the tip 412 is located distally of the cutting portion 410.

[0100] According to some exemplary embodiments, the cutting portion 410, e.g., a foldable cutting portion, includes a cutting edge 411. In some embodiments, the cutting edge 411 is located on the distal surface of the cutting portion 410 facing the tissue. Optionally, the cutting edge 411 is the leading edge of the cutting portion 410.

[0101] According to some exemplary embodiments, the cutting end 411 is sharp. Additionally or alternatively, in some embodiments, the cutting portion is thin, for example, less than 0.5 mm, for example, less than 0.3 mm, less than 0.1 mm, or has a thickness of any intermediate, smaller, or larger value. In some embodiments, the length of the cutting end 411 ranges from 2 to 50 mm, for example, 5 to 10 mm, 8 to 15 mm, 12 to 20 mm, 15 to 30 mm, or any intermediate, smaller, or larger value range. In some embodiments, the ratio between the length or the maximum width, for example, the maximum distance between two points on the cutting end, and the thickness of the cutting end is at least 10:1, for example, at least 20:1, at least 30:1, or any intermediate, smaller, or larger ratio value. In some embodiments, the ratio between the length of the cutting end 411 and the maximum width / diameter of the cutting end is at least 2:1, for example, at least 5:1, at least 20:1, or any intermediate, smaller, or larger ratio.

[0102] According to some exemplary embodiments, the cutting end 411 is planar, for example, straight. In some embodiments, the planar cutting end is used for making a straight cut, as described, for example, in FIGS. 2B and 2C.

[0103] According to some exemplary embodiments, the cutting end 411 is curved. In some embodiments, the curved cutting end has a radius of curvature in the range of 0.2 to 20 mm, for example, 0.2 to 5 mm, 5 to 10 mm, 7 to 15 mm, 10 to 20 mm, or any intermediate, smaller, or larger value range.

[0104] According to some exemplary embodiments, a particular tissue penetrator having a particular type of cutting end is selected according to the type of tissue to be cut. For example, if the cut needs to be made in a tissue wall with low elasticity, such as the tissue wall of the intestine or duodenum, a tissue penetrator having a planar cutting end is selected. Alternatively, if the cut needs to be made in an elastic tissue, such as the wall of the stomach, a tissue penetrator having a curved cutting end is selected. Alternatively or additionally, a particular type of penetrator having a particular cutting end is selected according to the outer diameter of the tube that needs to penetrate the formed cut.

[0105] According to some exemplary embodiments, the elongated body 408 comprises a shaft. In some embodiments, the elongated body 408 is flexible and bendable, for example, allowing it to bend while at least one of the assembly 400, the biopsy tube 404, and / or the tissue penetrator 402 is steered towards a desired target region within the body. In some embodiments, the elongated body is bendable at an angle of at least 40 degrees, such as 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 from stainless steel, steel, a steel alloy, such as cobalt chrome, a superelastic alloy, such as NiTi, or a shape memory alloy.

[0106] According to some exemplary embodiments, the width 409 of the elongated body 408 is, for example, 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, in order to allow the tissue penetrator 402 to support the biopsy tube 404 during navigation to the desired target region. In some embodiments, the thickness of the 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.

[0107] According to some exemplary embodiments, the maximum width or maximum diameter of the tissue penetrator body 408 ranges from 0.30 to 7 mm, such as 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 range. In some embodiments, the maximum width or maximum diameter of the lumen 406 is greater than the maximum diameter of the tissue penetrator body by at least 0.02 mm, such as at least 0.5 mm, at least 1 mm, at least 3 mm, or any intermediate, smaller, or larger value.

[0108] According to some exemplary embodiments, the cutting portion 410 is a reconfigurable cutting portion and is configured to move from an expanded state to a folded state, such as described in FIG. 2A. In some embodiments, as shown in FIG. 4A, for example, it is in an expanded state. The cutting portion is located outside and distal to the biopsy tube 404. In some embodiments, the cutting portion 410 is mechanically connected to a portion of the body 408 that extends from the biopsy tube lumen 406, such as through the distal opening 416. Alternatively, the cutting portion 410 is an integral part of the body 408.

[0109] According to some exemplary embodiments, as shown in FIG. 4A, for example, it is in an expanded state. The maximum width 414 of the cutting portion 410 is greater than the maximum width 418 or maximum diameter of the inner lumen 406. In some embodiments, in the expanded state, the maximum width 414 of the cutting portion 410 is greater than the maximum width or maximum diameter of the distal opening 416 of the inner lumen. In some embodiments, the maximum width 414 of the cutting portion 410 is in the range of 0.40 to 8 mm.

[0110] According to some exemplary embodiments, in the expanded state, the cutting portion includes a single continuous distal cutting edge facing the tissue. Alternatively, the cutting portion comprises two or more distally extending sections each having a distal cutting edge facing the tissue. Alternatively, the cutting portion includes sections extending in two or more distal directions of a single continuous cutting edge. In some embodiments, the cutting portion extends distally to form the tip 412.

[0111] According to some exemplary embodiments, the cutting portion is reshaped to enter the inner lumen 406 of the biopsy tube, as shown, for example, in FIG. 4B. In some embodiments, the reshaping of the cutting portion is induced by retracting and / or rotating the tissue penetrator 402, such as 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 the reshaped, e.g., folded state, the maximum width or diameter of the cutting portion is smaller than the internal width or diameter of the inner lumen 406, e.g., to enable removal of the tissue penetrator 402 from the body through the inner lumen of the biopsy tube, as described in block 312 of FIG. 3.

[0112] According to some exemplary embodiments, the retraction and / or rotation of the tissue penetrator body 408 induces, for example, the lifting or rotation of at least a portion of the cutting portion 410 to obtain a desired shape having dimensions, e.g., width or diameter, smaller than those of the inner lumen 406. Alternatively or additionally, the retraction and / or rotation of the tissue penetrator body 408 guides, for example, at least a portion of the cutting portion to fold to obtain a desired shape. In some embodiments, the retraction and / or rotation of the tissue penetrator body 408 bends two or more ends of the cutting portion until overlaps are formed.

[0113] Now refer to FIGS. 5A and 5B, which show the connection between the tissue penetrator and the biopsy tube according to some exemplary embodiments of the present invention.

[0114] According to some exemplary embodiments, the tissue penetrator is coupled to the biopsy tube, for example, during navigation of the biopsy assembly to a target region within the body. In some embodiments, the tissue penetrator is reversibly coupled to the biopsy tube, for example, to enable removal of the tissue penetrator before or during tissue sampling.

[0115] According to some exemplary embodiments, by coupling the tissue penetrator to the biopsy tube, the biopsy tube can support a cut that extends distally relative to an external pressure applied to the cut portion during navigation, for example. In some embodiments, during navigation, as shown, for example, in FIG. 4A, the cut portion 410 is pressed against the distal end of the biopsy tube body 415 that surrounds the edge of the opening 416 by a force applied by the tissue. In some embodiments, the cut portion is shaped and configured to be pressed against the body 415 without being folded.

[0116] According to some exemplary embodiments, the minimum thickness of the wall of the biopsy tube body is at least 5%, for example at least 10%, at least 15%, at least 20%, or any intermediate, smaller, or larger percentage value of the inner diameter of the biopsy tube. In some embodiments, the minimum thickness of the wall of the biopsy tube body is at least 0.03 mm, for example at least 0.05 mm, at least 0.07 mm, at least 0.1 mm, or any intermediate, smaller, or larger value.

[0117] According to some exemplary embodiments, as shown, for example, in FIG. 5A, the coupling between the tissue penetrator 402 and the biopsy tube 404 is created by a coupler 504 located in the proximal section 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 towards the target region. In some embodiments, the coupler axially fixes the position of the tissue penetrator 402 relative to the biopsy tube 404 while optionally allowing rotation of the biopsy tube and / or the tissue penetrator relative to each other. In some embodiments, the coupler 504 comprises a reversible lock, for example a reversible interlock mechanism. In some embodiments, the force applied to the cut portion presses the tissue penetrator against the interlock mechanism. In some embodiments, the interlock mechanism transmits at least a portion of the applied force to the biopsy tube.

[0118] According to some exemplary embodiments, as shown, for example, in FIG. 5B, release of the interlock mechanism enables, for example, reformation of the cut portion and / or retraction of the tissue penetrator 402 through the lumen of the biopsy tube 502. In some embodiments, detachment of the tissue penetrator 402 from the biopsy tube 404 is irreversible. Optionally, the coupler 504 is part of a mechanism for rotation and / or retraction of the tissue penetrator, for example enabling reformation of the cut portion.

[0119] Exemplary tissue penetration According to some exemplary embodiments, a biopsy assembly including a biopsy tube and a tissue penetrator is advanced through body tissue toward a desired target region. In some embodiments, at least a portion of the tissue penetrator, such as a cutting portion, is located distal to the biopsy tube and is shaped and sized to penetrate and cut as the assembly advances toward the target region. In some embodiments, the cut formed by the cutting portion allows for easy passage of the biopsy tube, which is located proximal to the cutting portion, through the tissue. Here, reference is made to FIGS. 6A - 6E, which illustrate tissue penetration according to some exemplary embodiments of the present invention.

[0120] 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 the tissue, the tissue penetrator body 608 is located within the inner lumen 609 of the biopsy, and the cutting portion 610 of the tissue penetrator 604 connected to the body 608 extends distally from the biopsy tube 606. In some embodiments, the cutting portion is in an expanded state when extending out from the biopsy tube, and the maximum width of the cutting portion is greater than or of a similar width, such as the outer diameter, of the biopsy tube.

[0121] According to some exemplary embodiments, the tissue penetrator includes a distal tip, such as a sharp distal tip 612, located distal to the cutting portion. In some embodiments, the distal tip is an integral part of the cutting portion 610. Alternatively, the distal tip is an integral part of the body 608, for example, in embodiments where the body extends out from the biopsy tube and is connected to the cutting portion.

[0122] According to some exemplary embodiments, as shown, for example, in FIG. 6B, the assembly 602 advances through and into the tissue 614, with the tip 612 penetrating the tissue 614, while the expanded cut portion 610 forms a thin cut 616 having a width similar to that of the wider, or proximally disposed, biocompatible tube 606. In some embodiments, as the tissue penetrator advances through the tissue, the tissue applies a force to the cut portion. In some embodiments, the force applied to the cut portion presses the cut portion against the biopsy tube, which structurally supports the cut portion without inducing reshaping, e.g., folding of the cut portion. Alternatively, a coupler, such as the coupler 504 shown in FIGS. 5A and 5B, structurally supports the tissue penetrator body against the force applied to the cut portion 610.

[0123] According to some exemplary embodiments, as shown, for example, in FIG. 6B, when the assembly 602 reaches the desired target region within 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 cut portion 610 is reshaped, e.g., folded, to assume a shape and / or size that can, for example, fit within the inner lumen 609 of the biopsy tube 606.

[0124] According to some exemplary embodiments, as shown, for example, in FIG. 6C, the cut portion 610 is reshaped, e.g., folded, by retraction and / or rotation of the body 608. In some embodiments, retraction of the tissue penetrator body 608 causes the cut portion to fold, e.g., during and / or prior to entry into the biopsy tube lumen 609.

[0125] According to some exemplary embodiments, the tissue penetrator is removed from the body, as shown, for example, in FIG. 6D. In some embodiments, the biopsy tube is advanced into the tissue and proceeds at least partially through cut 616, as shown, for example, in FIG. 6E. In some embodiments, cut 616 allows for easy entry of the biopsy tube through, for example, tissue wall 611. Alternatively or additionally, the shape and / or size of the cut allows for self-sealing by the tissue, for example, to prevent leakage through the cut in the tissue wall when the biopsy tube is retracted.

[0126] Reforming of an exemplary cut portion According to some exemplary embodiments, the tissue penetrator includes a longitudinal axis, a distal section shaped and sized to contact the tissue, and a proximal section. In some embodiments, a foldable cut portion configured to reform and acquire a narrow shape, such as a narrow shape that fits within the inner lumen of the biopsy tube, is located in the distal section. In some embodiments, the cut portion has a cutting edge on the outer surface of the cut portion facing the tissue. In some embodiments, an elongate body connected to the cut portion is located in the proximal section. Optionally, the cut portion is integrated with the elongate body.

[0127] According to some exemplary embodiments, the cut portion is reformed by a force applied to the cut portion by a biopsy tube in which the tissue penetrator body is disposed. In some embodiments, the cut portion is bendable, for example, to allow folding of the cut portion. Optionally, the cut portion is elastic, for example, to allow folding of the cut portion and to return to a previous expanded shape. Referring now to FIGS. 7A - 7F, which show the reforming of the cut portion according to some exemplary embodiments of the present invention.

[0128] According to some exemplary embodiments, a tissue penetrator, e.g., tissue penetrator 702, comprises a proximal elongated body 704, a distal cutting portion 706 connected to the elongated body, and a longitudinal axis 716. In some embodiments, tissue penetrator 702 is at least partially disposed within the inner lumen 708 of biopsy tube 710. In some embodiments, as shown, for example, in FIG. 7A, the cutting portion extends at least partially distally from the inner lumen 708.

[0129] According to some exemplary embodiments, the cross-section or protrusion of the cutting portion, e.g., cutting portion 706, is diamond-shaped, triangular, curved or triangular with angled corners, or diamond-shaped. In some embodiments, the cutting portion is a foldable cutting portion configured to fold inwardly towards the longitudinal axis 716 of the tissue penetrator. In some embodiments, the cutting portion is configured to collapse inwardly in response to an inward force applied, for example, by biopsy tube 710, on both sides of cutting portion 706 at one or more contact points between cutting portion 706 and biopsy tube 710, e.g., contact points 712 and 714.

[0130] According to some exemplary embodiments, as shown, for example, in FIG. 7B, upon inward folding, cutting portion 706 is reshaped to have a maximum width that is smaller than the minimum width of the inner lumen 708 of the biopsy tube.

[0131] According to some exemplary embodiments, while the tissue penetrator 702 and the biopsy tube 710 advance through the tissue, the biopsy tube 710 supports the cutting portion 706 at one or more contact points against the force applied by the tissue on the cutting portion 706. In some embodiments, the force applied by the tissue is lower than the force value required to induce reshaping. In some embodiments, the shape of the cutting portion is configured to resist force values ranging from 0.5 to 5 Newtons (N), such as 0.5 to 2 N, 1 to 3 N, 2 to 5 N, or any intermediate, smaller, or larger value, without reshaping, for example, by tilting with respect to the biopsy tube 710. In some embodiments, the retraction of the tissue penetrator exceeds this force value, resulting in the reshaping of the cutting portion.

[0132] According to some exemplary embodiments, as shown, for example, in FIG. 7C, the cutting portion 718 has a cross-section shaped as a triangle, and the base of the triangle 719 tilts with respect to the biopsy tube body 710 while advancing through the body tissue.

[0133] According to some exemplary embodiments, the wall 720 of the tissue penetrator is disposed 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, between the tissue penetrator wall and the tissue penetrator body 721. In some embodiments, the wall 720 tilts with respect to the biopsy tube 710 without causing reshaping of the cutting portion in order to support the cutting portion 718 against the force applied by the tissue to the cutting portion when the cutting portion advances through the tissue.

[0134] According to some exemplary embodiments, the retraction of the body 721 applies a force to the cutting portion 718 by the biopsy tube 710, resulting in the folding of the cutting portion 718 inward, for example, toward the longitudinal axis 716. In some embodiments, in the folded state, as shown, for example, in FIG. 7D, the maximum width of the cutting portion is smaller than the minimum width of the inner lumen 708 of the biopsy tube.

[0135] According to some exemplary embodiments, as shown, for example, in FIG. 7E, the tissue penetrator comprises a distal cutting portion 732 connected to or integrated with the proximal body 734. In some embodiments, the tissue penetrator 730 comprises a stopper 736 proximal to the cutting portion when the cutting portion is in the expanded state, for example, located between the cutting portion 732 and the biopsy tube body 738. In some embodiments, while the tissue penetrator 730 advances through the tissue, the force applied to the cutting portion 732 by the tissue presses the stopper 736 against the body 738.

[0136] According to some exemplary embodiments, the stopper 736 is configured to resist the pressure applied by the biopsy tube body 738 on the tissue penetrator while advancing through the tissue, and the cutting portion 732 is not reshaped, for example, folded. In some embodiments, the stopper is configured to prevent direct contact between the biopsy tube body 738 and the cutting portion 732. In some embodiments, for example, while advancing through the tissue, the stopper is reversibly mechanically coupled to the biopsy tube body 738. In some embodiments, the stopper is coupled to the tissue penetrator body 734.

[0137] According to some exemplary embodiments, the retraction of the tissue penetrator 730 is performed as shown, for example, in FIG. 7F. A force on the stopper 736 greater than the force the stopper 736 can resist is applied. In some embodiments, the force applied to the stopper 736 during the retraction of the tissue penetrator 730 relative to the biopsy tube 738 deforms the stopper 736. In some embodiments, the deformation of the stopper results in direct contact between the biopsy tube 738 and the cutting portion 730, for example, a foldable cutting portion, and folds the cutting portion 730 as described, for example, in FIG. 7B. In some embodiments, the stopper is configured to withstand pressures in the range of up to 0.5 - 5 N, for example, 0.5 - 2 N, 1 - 3 N, 2.5 - 4 N, 3.5 - 5 N, or any intermediate, smaller or larger value.

[0138] Referring now to FIG. 7G, which shows, according to some exemplary embodiments of the present invention, the penetration angle between the cutting portion of the tissue penetrator and the tissue wall, and the angle between the cutting portion and the biopsy tube.

[0139] According to some exemplary embodiments, a tissue penetrator, such as tissue penetrator 750, includes a cutting portion 752, such as a foldable 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 the tissue, such as tissue wall 754, is non-planar, such as surface 756.

[0140] According to some exemplary embodiments, the outer surface of the cutting portion 752 facing the tissue, such as surface 756, is disposed at an angle 758 greater than 45 degrees, such as greater than 50 degrees, greater than 60 degrees, greater than 70 degrees, greater than 87 degrees, or any intermediate, smaller, or larger angle, between the surface 756 and the tissue wall 754. In some embodiments, an angle greater than 45 degrees between the outer surface of the cutting portion facing the tissue and the tissue allows, for example, entry into the tissue while applying a low axial force by the cutting portion 752 on the tissue 754.

[0141] According to some exemplary embodiments, the outer surface of the cutting portion 752, for example, the surface 760 facing the biopsy tube 762 in which the tissue penetrator is disposed, is disposed at an angle with respect to the biopsy tube 762. In some embodiments, the angle 764 between the biopsy tube 762 and the surface 760 is greater than 45 degrees, for example, greater than 50 degrees, greater than 60 degrees, greater than 70 degrees, greater than 87 degrees, or any intermediate, smaller, or larger angle between the surface 760 and the biopsy tube 762. In some embodiments, the angle greater than 45 degrees between the outer surface of the cutting portion facing the biopsy tube and the tissue biopsy tube enables, for example, folding of the cutting portion by applying a relatively low axial force to the penetrator body 734 by the biopsy tube 762, for example, by retracting the penetrator body into the inner lumen of the biopsy tube.

[0142] Now, referring to FIG. 7H, which shows a tissue penetrator having a curved sidewall according to some exemplary embodiments of the present invention.

[0143] According to some exemplary embodiments, a tissue penetrator, for example, the tissue penetrator 770, comprises a cutting portion 772, for example, a foldable cutting portion, connected to an elongated body 776. In some embodiments, the cutting portion 772 comprises a distal tip, for example, a distal tip 771 connected to the elongated body 776 via side surfaces 774 and 775, for example, side surfaces. In some embodiments, for example, as shown in FIG. 7H, the side surfaces 774 and 775 are curved, for example, non-angled. In some embodiments, the side surfaces are curved when the cutting portion is in an expanded state, for example, when the cutting portion extends out of the inner lumen of the biopsy tube body 738. Optionally, the distal tip of the cutting portion is curved. Optionally, the outer edge of the cutting portion is completely curved. Alternatively, at least a portion of the outer edge is curved.

[0144] Exemplary tissue penetrator having a curved cutting portion Referring now to FIGS. 8A - 8E, which illustrate a tissue penetrator having a curved cutting portion, according to some exemplary embodiments.

[0145] According to some exemplary embodiments, the tissue penetrator 800 includes an elongated body 806 having a proximal section 802 and a distal section 804. In some embodiments, the elongated body 806 includes an elongated shaft. In some embodiments, the shaft is flexible, for example, to allow bending of the tissue penetrator while advancing through a sleeve, such as 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 penetration of tissue into the shaft. Optionally, the distal tip 808 is inclined. Optionally or additionally, the distal tip 808 is at least partially pointed, for example, to facilitate penetration of tissue.

[0146] According to some exemplary embodiments, a cutter, such as a cutting portion 810, is mechanically connected to the distal section 804 of the elongated body 806, such as the distal section of the shaft. In some embodiments, the distal tip 808 is positioned distal to the cutting portion 810. In some embodiments, the cutting portion 810 is at least partially curved.

[0147] According to some exemplary embodiments, the cutting portion 810 has a curved surface that curves around the longitudinal axis of the tissue penetrator, e.g., around the longitudinal axis of the elongated body 806. In some embodiments, the maximum length of the curved surface perpendicular to the elongated body is greater than the width of the elongated body. In some embodiments, the arc length of the curved surface is fixed. Alternatively, the length of the arc varies along the longitudinal axis of the body 806. In some embodiments, the maximum arc length of the curved surface ranges from 0.8 to 20 mm, e.g., from 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. In some embodiments, the ratio of the overall width of the curved surface 810 of the cutting portion to the width or diameter of the elongated body 806 ranges between a ratio of 1:1 and a ratio of 15:1, respectively. In some embodiments, the maximum length of the cutting portion 810 along the longitudinal axis of the body 806 ranges from 1 to 60 mm, e.g., from 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.

[0148] According to some exemplary embodiments, the outer edges of the cutting portion 810 extending on both sides of the elongated body 806 are at least partially sharpened, e.g., to enable cutting of tissue as the tissue penetrator advances axially into the tissue. In some embodiments, for example, as shown in FIG. 9B, the maximum thickness 822 of the cutting portion 810 is less than 0.1 mm, e.g., 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 reducing the width of the inner lumen 819 from the width of the body 806 and dividing the result into at least 2, e.g., at least 3, at least 4, or any intermediate, smaller, or larger value.

[0149] According to some exemplary embodiments, as shown, for example, in FIGS. 8D and 8E, the cutting portion 810 is coupled to the elongated body 806 at one or more contact points along the body 806. In some embodiments, the cutting portion 810 is coupled to the elongated body by welding at one or more weld points, such as weld points 814 and 815. Alternatively, the cutting portion is coupled to the elongated body by soldering, adhesion, crimping, and any other joining option for metal parts.

[0150] According to some exemplary embodiments, as shown, for example, in FIGS. 8B-8E, the tissue penetrator is shaped and sized to be at least partially disposed within a biopsy tube 812, which is optionally a biopsy needle. In some embodiments, the tissue penetrator, such as the cutting portion 810 and the body 806, extends distally from the tube 812, such as through the distal opening 813 of the tube 812. In some embodiments, as shown, for example, in FIG. 8C, the maximum width of the cutting portion 810 is less than or equal to the outer width 811 of the biopsy tube 812 when the cutting portion is expanded. In some embodiments, the maximum width of the cutting portion is greater than the width of the inner lumen of the biopsy tube when the cutting portion is expanded.

[0151] Now refer to FIGS. 9A and 9B, which show a folded state, for example, a folded cutting portion, according to some exemplary embodiments of the present invention.

[0152] According to some exemplary embodiments, in the folded state, the tissue penetrator is inserted into the inner lumen 819 of the biopsy tube 812. In some embodiments, the cutting portion 810 is at least partially folded, for example, around the body 806. In some embodiments, the cutting portion 810 is flexible, for example, to enable folding in the folded state. In some embodiments, the cutting portion 810 is irreversibly foldable, for example, once folded inward, the cutting portion 810 cannot return to its previous shape. Optionally, the cutting portion is also elastic, for example, to enable return to a previous expanded state.

[0153] According to some exemplary embodiments, as shown, for example, in FIG. 9B, in the folded state, the cutting portion contacts the inner surface of the inner lumen 819 of the biopsy tube. Optionally, in the folded state, the sharp edge of the cutting portion is disposed at a distance from the inner surface of the lumen 819, for example, to prevent damage to the surface as the tissue penetrator moves within the lumen 819.

[0154] Now, refer to FIGS. 10A - 10D, which show the folding of a curved cutting portion according to some exemplary embodiments of the present invention.

[0155] According to some exemplary embodiments, as shown, for example, in FIG. 10A, the curved cutting portion 1004 is coupled to the tissue penetrator body, for example, the shaft 1006. In some embodiments, in the expanded state shown in FIG. 10A, the maximum width 1012 of the cutting portion 1004 is greater than the width 1014 of the inner lumen 1008 of the biopsy tube 1010 in which the tissue penetrator is at least partially located. In some embodiments, in the expanded state, the cutting portion extends at least partially from the inner lumen 1008.

[0156] According to some exemplary embodiments, for example, as shown in FIG. 10B, the cut portion 1004 is configured to be folded, for example, like a fold, to obtain a width 1016 that is smaller than the width of the inner lumen 1008. In some embodiments, the cut portion has sufficient elasticity to bend inward, for example, to obtain a width that is smaller than the width of the inner lumen 1008.

[0157] Alternatively, for example, as shown in FIGS. 10C and 10D, the curved cut portion 1014 coupled to the tissue penetrator body 1016 is configured to be at least partially wound within the lumen 1008, for example, to rotate. In some embodiments, when the cut portion 1014 is at least partially wound, two opposing ends, for example, opposing ends 1017 and 1015, overlap and optionally contact each other. Alternatively, the two opposing ends of the cut portion are at least partially wound without overlapping, for example, as shown in FIG. 9B.

[0158] Exemplary tissue penetrator having an integrated cutting portion Now refer to FIGS. 11A and 11B, which show a tissue penetrator having an integrated cutting portion according to some exemplary embodiments of the present invention.

[0159] According to some exemplary embodiments, the tissue penetrator 1102 includes a proximal section 1104 and a distal section 1106. In some embodiments, the tissue penetrator includes an elongated body 1107 in the proximal section and a cutting portion 1108 in the distal section 1106. In some embodiments, the cutting portion 1108 is integrated with the body and is formed, for example, from the same sheet or layer of material.

[0160] According to some exemplary embodiments, the body 1107 and the cutting portion 1108 are formed from a single layer of material, for example, from a sheet of steel, stainless steel, a steel alloy such as cobalt chrome, or a superelastic alloy, a shape memory alloy such as nitinol. In some embodiments, the body 1107 is formed by bending a layer into a sealed tube having a shape and size such that it is disposed inside a tubular shape, for example, inside a biopsy tube. In some embodiments, the cutting portion is formed by cutting the tube, for example, using laser cutting. In some embodiments, a portion of the body that is shaped and sized to be disposed inside a biopsy tube has a fixed width or diameter that is smaller than the width or diameter of the biopsy tube. Additionally, the outer surface of the body 1107 is smooth, for example, to prevent damage to the inner surface of the biopsy tube.

[0161] According to some exemplary embodiments, the cutting portion is formed by bending a layer of material to form a concave shape and optionally has a tip 1109 that extends distally. In some embodiments, the maximum width of the cutting portion 1108 is greater than the maximum width of the body 1107.

[0162] According to some exemplary embodiments, the body 1107 includes a window or an opening, for example, opening 1111, to enable, for example, reducing a retraction force.

[0163] During the life of the patents that mature from this application, many related biopsy tubes are expected to be developed, and the scope of the term biopsy tube is intended to include, a priori, all such new technologies.

[0164] As used herein with respect to a quantity or numerical value, the term "about" means "within ±20%".

[0165] The terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” and their conjugations mean including but not limited to.

[0166] “Consisting of” means including and limited to.

[0167] The term “consisting essentially of” means that a composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially change the basic and novel characteristics of the composition, method or structure recited in the claims.

[0168] As used herein, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “compound” or “at least one compound” can include a plurality of compounds including mixtures thereof.

[0169] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the individual numerical values and all sub-ranges within that range. For example, a description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges 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., as well as the individual numerical values within that range, for example, 1, 2, 3, 4, 5, 6, etc. This applies regardless of the breadth of the range.

[0170] Whenever a numerical range (e.g., "10-15", "10-15", or any number of pairs linked by such other range indications) is shown in this specification, unless the context clearly states otherwise, it is meant to include any numerical value (fractional or integer) cited within the indicated range. In this specification, the expressions "range between / to" the first display number and the second display number, and "range from" the first display number "to" the second display number are used interchangeably, meaning to include the first and second display numbers, as well as all fractional and integer numbers therebetween.

[0171] Unless otherwise indicated, the numbers and any range of numbers based thereon used in this specification are approximations within the precision of reasonable measurement and rounding errors, as understood by those skilled in the art.

[0172] For clarity, certain features of the invention described in the context of separate embodiments may be provided in combination in a single embodiment, and this specification is to be read as if such combinations were explicitly recited herein. Conversely, for brevity, the various features of the invention described in the context of a single embodiment may also be provided separately, or in any suitable partial combination, or appropriately in other described embodiments of the invention, and this specification is to be read as if such combinations were explicitly defined herein. Specific features described in the context of various embodiments are not considered essential features of those embodiments, except where the embodiments would not function without those elements.

[0173] Although the description of this disclosure is provided in relation to specific embodiments, it is apparent that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0174] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. Also, the documents cited or identified in this application should not be construed as an admission that such documents are available as prior art to the present invention. To the extent that section headings are used, they should not necessarily be construed as limiting. Also, the priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. A biopsy tube defining a lumen, and a tissue penetrator having a distal tip shaped to penetrate tissue, comprising: The tissue penetrator is disposed within the lumen, and is formed as a flexible, elongated body sized and shaped to move within the lumen of the biopsy tube, a foldable distal cutting portion coupled to the body and configured to extend outward from the lumen in an expanded state and fold to a width smaller than the inner width of the lumen in a folded state, the foldable distal cutting portion having a sharp distal cutting edge configured to effect a thin cut through the tissue, the maximum width of the cutting portion in the expanded state being greater than the inner width or inner diameter of the lumen of the biopsy tube; The biopsy assembly, wherein the foldable cutting portion is formed from a single thin, flexible layer of material configured to bend around the flexible, elongated body to a width smaller than the inner width of the lumen.

2. The biopsy assembly of claim 1, wherein the foldable distal cutting portion is in the form of a thin, flexible layer.

3. The foldable distal cutting portion includes the sharp distal cutting edge facing the tissue on the surface of the foldable distal cutting portion, the sharp distal cutting edge being configured to effect the thin cut through the tissue as the tissue penetrator advances into the tissue while the foldable distal cutting portion extends from the biopsy tube and is in the expanded state; the biopsy assembly of claim 1 or 2.

4. The biopsy assembly of any one of claims 1 to 3, wherein the foldable distal cutting portion is integrated with the elongated body.

5. The biopsy assembly of any one of claims 1 to 4, wherein the distal tip is integrated with the foldable distal cutting portion.

6. The biopsy assembly according to any one of claims 1 to 5, wherein the foldable distal cutting portion is at least partially flexible.

7. The biopsy assembly according to any one of claims 1 to 6, wherein the foldable distal cutting portion is thin and the ratio between the thickness of the cutting portion and the maximum width or diameter thereof is greater than 1:

8.

8. The biopsy assembly according to any one of claims 1 to 7, wherein the thickness of the sharp distal cutting edge is less than 0.1 mm.

9. The biopsy assembly according to any one of claims 1 to 8, wherein the tissue facing the surface of the foldable tissue penetrator having the sharp distal cutting edge is at least partially angled or at least partially curved.

10. The biopsy assembly according to claim 9, wherein the angle between the surface and the tissue is greater than 20 degrees.

11. The biopsy assembly according to any one of claims 1 to 10, wherein the side surface of the foldable tissue penetrator is curved.

12. The biopsy assembly according to any one of claims 1 to 11, wherein the cross-section of the circumference of the foldable distal cutting portion facing the tissue is a continuous arc in the expanded state.

13. The biopsy assembly according to claim 12, wherein the arc forms an angle of at least 30 degrees.

14. The biopsy assembly according to claim 12 or 13, wherein the radius of curvature of the arc ranges from 0.2 to 20 mm.

15. The biopsy assembly according to any one of claims 12 to 14, wherein the length of the arc in the expanded state is up to 30 mm.

16. The angle between the surface of the cutting portion facing the biopsy tube in the expanded state and the biopsy tube is greater than 20 degrees, the biopsy assembly according to any one of claims 1 to 15.

17. The biopsy assembly according to any one of claims 1 to 16, comprising a coupler configured to reversibly couple the flexible elongated body of the tissue penetrator to the biopsy tube.

18. The biopsy assembly according to claim 17, wherein the coupler is configured to axially fix the position of the tissue penetrator relative to the biopsy tube.

19. The foldable cutting portion is formed from a thin flexible layer of material configured to at least partially wrap around the flexible elongated body to a width smaller than the inner width of the lumen, the biopsy assembly according to any one of claims 1 to 18.

20. The protrusion of the foldable cutting portion is shaped as a triangle, the biopsy assembly according to any one of claims 1 to 19.

21. The outer surface of the foldable distal cutting portion is smooth, the biopsy assembly according to any one of claims 1 to 20.

22. The foldable distal cutting portion is axially rigid and bendable in the transverse and / or tangential directions, the biopsy assembly according to any one of claims 1 to 21.

23. The minimum thickness of the wall of the biopsy tube surrounding the lumen is at least 10% of the inner diameter of the biopsy tube, the biopsy assembly according to any one of claims 1 to 22.

24. The minimum thickness of the wall of the biopsy tube is 0.05 mm, the biopsy assembly according to any one of claims 1 to 23.

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