Patent Description:
The present invention, in some embodiments thereof, relates to a tissue penetrator and, more particularly, but not exclusively, to a tissue penetrator of a biopsy device.

Additional background includes U. Patent application No. <CIT> disclosing a biopsy device as defined in the preamble of claim <NUM>. The biopsy device may include a first jaw having a first distal tip configured to pierce tissue, and a second jaw movable relative to the first jaw between a closed configuration where the first jaw and the second jaw are axially aligned, and an open configuration where the first jaw and the second jaw are offset from one another, the second jaw having a second distal tip proximal to the first distal tip in the closed configuration.

Patent No. <CIT> disclosing an apparatus, comprising: a biopsy needle having a distal end and a proximal end, all or a portion of the biopsy needle being movable between a collapsed state and an expanded state; a sheath having a distal end and a proximal end, wherein the biopsy needle in the collapsed state is contained within the sheath, and in the expanded state at least the distal end of the biopsy needle extends from the distal end of the sheath; wherein the biopsy needle is provided with two or more sleeves, which at least partially overlap in the collapsed configuration and which cylindrically expand to provide an increased radius, relative to a radius in the collapsed state, for sampling in the expanded configuration, and wherein a cross section of the distal end of the biopsy needle in the expanded state is a substantially circular cross section.

Patent application No. <CIT> disclosing a biopsy assembly including a biopsy catheter having a proximal portion and a distal portion, a navigation catheter configured to receive the biopsy catheter for positioning the biopsy catheter adjacent target tissue, wherein the biopsy catheter is configured to be received within the navigation catheter, a coring component, and an anchoring component configured to anchor the biopsy catheter to target tissue. The coring component includes a proximal region and a distal region, the distal region formed of one or more distally extending blades and the proximal region being coupled to the distal portion of the biopsy catheter and the one or more blades are configured to penetrate target tissue and sever a tissue sample from the target tissue.

International Patent publication No. <CIT> disclosing a tissue sampling apparatus and method are disclosed. Some embodiments comprise a biopsy needle having a laterally expandable distal portion comprising spines which move away from each other when unconstrained and which move towards each other when constrained to do so by a sheath. In some embodiments said spines comprise inward-pointing teeth designed to catch tissue samples when said needle retracted from tissue. A method of use comprises providing such a needle within a sheath, advancing the sheath to near a sampling site, advancing needle beyond sheath to expand the expandable portion, retracting needle into sheath so that the expandable portion collapses and tissue samples are trapped between the teeth and spines, and removing the needle and the samples it contains from the body.

International Patent publication No. <CIT> disclosing a device for collecting a tissue sample includes an outer sheath extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough. The device also includes a tissue collecting member movably housed within the lumen and biased toward an expanded configuration in which the member is curved about a longitudinal axis thereof and longitudinal edges thereof are separated from one another. The member is movable between a constrained position, in which the tissue collecting is received within the lumen and constrained by a surface thereof such that longitudinal edges of the member are drawn toward one another to define a channel therein, and a tissue collecting position, in which the member moves distally past the distal end of the outer sheath to revert to the biased expanded configuration to cut a target tissue into which it is inserted.

The invention relates to a biopsy assembly as defined in claim <NUM>. Additional embodiments are defined in the dependent claims.

The present disclosure relates to a tissue penetrator and, more particularly, but not exclusively, to a tissue penetrator of a biopsy device. Throughout the description, the term "embodiment" is to be understood as "example of the disclosure". The invention is solely defined by the claims.

An aspect of some embodiments relates to collapsing at least a portion of a tissue penetrator, for example a stylet, prior to taking biopsy. In some embodiments, a cutting portion of the tissue penetrator is collapsed into a sampling tube, for example a sampling needle, prior to taking 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 cutting portion is collapsed into an inner lumen of the sampling tube, for example to allow removal of the tissue penetrator from the body.

According to some embodiments, the cutting portion is collapsed into the sampling tube, for example, when the sampling tube reaches a desired target tissue in the body that needs to be sampled. In some embodiments, the cutting portion is collapsed when the sampling tube is close, for example at a distance smaller than <NUM>, for example a distance smaller than <NUM>, a distance smaller than <NUM> or any intermediate, smaller or larger values from a desired target tissue. Alternatively, the cutting portion is collapsed when the sampling tube is in contact with a desired target tissue.

According to some embodiments, in an expanded state, the cutting portion is wider than an opening of the sampling tube. In some embodiments, a width of the cutting portion in a collapsed state is smaller than a minimal width, for example a minimal inner diameter, of the sampling tube. In some embodiments, in an expanded state the width of the cutting portion is similar or smaller than an outer diameter or the maximal width of the sampling tube. In some embodiments, in the expanded state, the maximal width of the cutting portion, for example a maximal distance between two points on the cutting portion, is in a range between half of a sampling tube circumference and a diameter of the sampling tube.

According to some embodiments, the cutting portion, for example a collapsible cutting portion, is rigid in an axial direction, for example to allow penetration through a tissue wall or a membrane without collapsing. Additionally, the cutting portion is bendable in a lateral and/or a tangential direction, for example to allow collapsing, for example bending into the tube, for example a biopsy tube. In some embodiments the tissue wall comprises the gastric wall, duodenum wall, the intestine wall, Trachea wall, Bronchial airways walls, blood vessel walls, GI tract walls, esophagus wall, an epithelium layer, the skin, the diaphragm, a pleura, heart wall, and/or heart septum.

According to some embodiments, in an expanded state, the cutting portion is straight, for example when penetrating through a tissue wall with lower self-sealing properties, for example an intestine wall or a duodenum wall, and therefore a straight cut is formed to minimize leakage through the formed cut. Alternatively, in an expanded state, the cutting portion is curved, for example when penetrating through a tissue wall with high self-sealing properties, for example a wall of the stomach, and therefore a curved cut is formed to maximize ease of penetration through the tissue wall. Optionally, the tissue wall is a thick tissue wall having a thickness larger than <NUM>, for example larger than <NUM>, larger than <NUM> or any intermediate, smaller or larger value.

A potential advantage of generating a cut in the tissue which has a maximal width, for example a maximal distance between two points on the cut, which is in a range between half of a circumference length of the sampling tube and a sampling tube diameter may be, to allow easier penetration of the sampling tube through a wall, for example a wall of the stomach, an intestine wall, and/or a duodenum wall, while preventing leakage though the formed cut.

An aspect of some embodiments relates to removing a wide tissue penetrator from a target tissue through a narrow opening of a biopsy tube lumen. In some embodiments, at least a portion of the wide tissue penetrator, for example a cutting portion, is reshaped to enter through the opening. In some embodiments, at least a portion of the tissue penetrator is collapsed to a width smaller than a minimal width, for example inner diameter of the biopsy tube opening. Optionally, the at least a portion of the tissue penetrator is reversibly collapsed to enter through the biopsy tube lumen opening. In some embodiments, at least a portion of the tissue penetrator is collapsed into the biopsy tube lumen without sampling tissue.

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, the at least a portion of the tissue penetrator is at least partly furled or at least partly rolled to acquire a shape having a cross section which is narrower than the biopsy tube lumen opening. In some embodiments, when the cutting portion is furled, two or more ends of the cutting portion, overlap.

According to some embodiments, the cutting portion of the tissue penetrator is reshaped, by application of external force on the tissue penetrator, for example by retracting the tissue penetrator, for example through the biopsy tube lumen. Alternatively, the cutting portion is reshaped by rotating the tissue penetrator at least <NUM>° degrees, for example at least <NUM>° degrees, <NUM>° degrees, <NUM>° degrees or any intermediate, smaller or larger rotation degree. In some embodiments, the cutting portion is reshaped by a force applied on the cutting portion by biopsy tube body, causing the cutting portion to reshape.

According to some embodiments, the tissue penetrator is used in a biopsy sampling process of a tissue, for example a tissue suspected to be a malignant tissue.

According to some embodiments, an endoscope is navigated towards a target tissue that needs to be sampled. In some embodiments, when reaching a tissue wall, for example a tissue wall surrounding the target tissue, a tissue penetrator is expanded through a distal opening of the endoscope. In some embodiments, expansion of a tissue penetrator comprises expansion of the cutting portion of the tissue penetrator.

According to some embodiments, when reaching a tissue wall of the desired target or any tissue wall in a way to a desired target tissue, the tissue penetrator is advanced 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 <NUM>, up to <NUM>, for example up to <NUM>, for example up to <NUM>, or any intermediate, smaller or larger distance from the tissue wall cut.

According to some embodiments, the tissue penetrator is part of a biopsy assembly comprising a biopsy tube. In some embodiments, when the endoscope reaches a tissue wall, the biopsy assembly, having an expanded cutting portion extended from a distal end of the biopsy tube, is advanced through the tissue wall. In some embodiments, when the biopsy assembly penetrates through the tissue wall and optionally at least partly into a target tissue, the tissue penetrator blocks an inner lumen of the biopsy tube, preventing penetration of tissue into the biopsy tube.

According to some embodiments, after forming a cut in the tissue wall, the tissue penetrator is retracted into the biopsy tube inner lumen, for example to unblock an 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, into the target tissue, for example as described in <CIT>. In some embodiments, the tissue sampling comprises advancement of the biopsy tube one or more times, for example <NUM>, <NUM>, <NUM> times or any number of times, into the target tissue.

According to some embodiments, the advancement, for example 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, for example as described in <CIT>.

According to some embodiments, the tissue wall comprises a muscle or any type of tissue located between a biopsy tube, or any type of a tube inserted into the body, and a desired target tissue. A potential advantage of the tissue penetrator may be to allow penetration through a tissue wall without or with minimal sampling of the tissue wall, for example sampling of less than <NUM>%, less than <NUM>%, less than <NUM>% of the volume of the tissue wall compared to the volume of the sampled target tissue.

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

According to some exemplary embodiments, during a biopsy sampling process, a biopsy tube, for example a biopsy needle having an external distal cutting portion used to penetrate through a tissue wall, for example a septum, towards a desired target tissue that needs to be sampled. In some embodiments, in order to allow easy penetration of the sampling tube into the target tissue, a cut in a tissue wall located between the target tissue to be sampled and the biopsy tube is formed by the tissue penetrator. In some embodiments, the cut has a width which is at least as wide as the external width of the biopsy needle and smaller than a half of an outer circumference of the biopsy tube. Reference is now made to <FIG>, describing a process for tissue cutting by a collapsible cutting portion, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a tissue penetrator having a collapsible cutting portion is advanced through tissue at block <NUM>. In some embodiments, the tissue penetrator is coupled to a biopsy tube, for example a biopsy needle. In some embodiments, at least part of the tissue penetrator is positioned within an inner lumen of the biopsy tube while the collapsible cutting portion of the tissue penetrator extends out from the biopsy tube. Optionally, the collapsible cutting portion extends through a distal opening of the biopsy tube, for example an opening facing the tissue.

According to some exemplary embodiments, the tissue penetrator is fixed to the biopsy tube, for example when advancing through the tissue at block <NUM>. In some embodiments, the tissue penetrator is fixed to the biopsy tube in an axial direction. Additionally, the biopsy tube, for example a rotating biopsy needle, rotates relatively to the tissue penetrator. Alternatively, the tissue penetrator rotates together with the biopsy tube.

According to some exemplary embodiments, the tissue penetrator forms a thin cut through tissue at block <NUM>. In some embodiments, the thin cut is formed by the collapsible cutting portion of the tissue penetrator, for example during the advancement of the tissue penetrator at <NUM>. In some embodiments, the cut formed by the collapsible cutting portion has a width which is similar or smaller than a maximal width of the biopsy tube. In some embodiments, the cut formed by the collapsible cutting portion has a length which is similar or smaller than a maximal width of the biopsy tube. In some embodiments, the cut formed by the collapsible cutting portion has a length which is similar or smaller than half or a circumference length of the biopsy tube.

According to some exemplary embodiments, the thin cut is formed in a wall of a tissue, for example in a wall of the stomach, the wall of the duodenum, the wall of the intestines and/or the wall of the bronchial airways. In some embodiments, the tissue wall is elastic. In some embodiments, the thin cut formed in the tissue wall allows, for example, penetration of a biopsy tube with minimal application of force on the tissue, while preventing or limiting leakage of fluid through the formed thin cut. Optionally, the thin cut allows, for example, an improved self-sealing of the tissue wall after the removal of the biopsy tube from the body.

According to some exemplary embodiments, the collapsible cutting portion in an expanded state, is straight, for example planar. In some embodiments, the straight collapsible cutting portion is used to form a straight cut, for example when the tissue penetrator penetrates through a tissue wall that has limited self-sealing properties, for example the duodenum wall, the intestine wall, Trachea wall, Bronchial airways walls, blood vessel walls, GI tract walls, esophagus wall or any wall of anatomical tubes. Alternatively, the collapsible cutting portion, in an expanded state, is curved. In some embodiments, the curved collapsible cutting portion is used to form a curved cut, for example when penetrating through a tissue wall that has better self-sealing properties, for example the stomach wall or any anatomical septum tissue, membrane, or tissue layer at least partly surrounding a tissue or an organ, for example epithelium layer, the skin, the diaphragm, a pleura, heart wall, and/or heart septum.

According to some exemplary embodiments, a thickness of the cut formed by the collapsible cutting portion is smaller than a maximal width, or an outer diameter of the biopsy tube.

According to some exemplary embodiments, the collapsible cutting portion of the tissue penetrator is reshaped, for example collapsed at block <NUM>. In some embodiments, at least part of the collapsible cutting portion is collapsed at block <NUM>. In some embodiments, the collapsible cutting portion is collapsed to acquire a width which is smaller than a minimal width of an inner lumen of the biopsy tube. In some embodiments, the cutting portion is collapsed when reaching a target tissue that needs to be sampled. Alternatively, the cutting portion is collapsed when reaching a distance smaller than <NUM>, for example smaller than <NUM>, smaller than <NUM>, smaller than <NUM> or any intermediate, smaller or larger distance from a target tissue that needs to be sampled.

According to some exemplary embodiments, the collapsible cutting portion is collapsed by application of force on the tissue penetrator, for example by rotating and/or retracting the tissue penetrator relative to the sampling tube. Alternatively, the collapsible cutting portion is collapsed by application of force on the sampling tube, for example by pushing, retracting and/or rotating the sampling tube relative to the tissue penetrator.

According to some exemplary embodiments, the tissue penetrator is removed from the tissue at block <NUM>. In some embodiments, once the collapsing portion is collapsed at block <NUM>, the tissue penetrator is removed from the tissue through the inner lumen of the sampling tube, for example by retraction of the tissue penetrator. In some embodiments, the tissue penetrator is removed from the body at block <NUM>. In some embodiments, the tissue penetrator is removed from the inner lumen of the sampling tube, for example to allow insertion of a tissue sample into the inner lumen of the biopsy tube. In some embodiments, the tissue penetrator is retracted within the biopsy tube lumen to a distance that clears a desired volume of the biopsy tube lumen, for example a volume of at least <NUM><NUM>, for example at least <NUM><NUM>, at least <NUM><NUM>, at least <NUM><NUM> or any intermediate, smaller or larger volume in the biopsy tube lumen, for example to allow entry of a tissue sample into the cleared volume.

According to some exemplary embodiments, a cutting portion of a tissue penetrator moves between an expanded state and a collapsed state. In some embodiments, the collapsed state is irreversible, and for example prevents re-use of the cutting portion. Alternatively, the collapsed state is reversible, and allows return to an expanded state. In some embodiments, in a collapsed state a maximal width of the cutting portion is smaller than a minimal width of an inner lumen of a biopsy tube, for example to allow removal of the tissue penetrator from a tissue through the inner lumen of the biopsy tube. Reference is now made to <FIG>, depicting transition between an expanded state and a collapsed state of the tissue penetrator cutting portion, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, in an expanded state <NUM>, at least part of a tissue penetrator cutting portion is expanded. In some embodiments, the cutting portion extends out from an opening of a biopsy tube inner lumen. In some embodiments, the cutting portion extends out and faces tissue located at an advancement path of the tissue penetrator. In some embodiments, in an expanded state a maximal width of the cutting portion is larger or similar to the maximal external width, for example maximal outer diameter, of the biopsy tube.

According to some exemplary embodiments, in a reshaped state, for example in a collapsed state <NUM>, at least a portion of the tissue penetrator, for example at least part of the cutting portion is collapsed. In some embodiments, at least part of the cutting portion is collapsed to acquire a maximal width of the cutting portion that is smaller than a minimal width of the biopsy tube inner lumen. In some embodiments, in a collapsed state, the tissue penetrator is shaped and sized to be moved into the biopsy tube inner lumen.

According to some exemplary embodiments, the cutting portion of the tissue penetrator reversibly moves between an expanded state <NUM> to a collapsed state. Alternatively, the cutting portion irreversibly moves to a collapsed state. In some embodiments, the cutting portion of the tissue penetrator moves between an expanded state <NUM> and a collapsed state <NUM> by axially moving one or both of the biopsy tube and the tissue penetrator or a portions thereof, relative to each other. Alternatively or additionally, the cutting portion of the tissue penetrator moves between an expanded state <NUM> and a collapsed state <NUM> by rotating one or both of the biopsy tube and the tissue penetrator or portions thereof, relative to each other.

According to some exemplary embodiments, the tissue penetrator, for example a collapsible cutting portion of the tissue penetrator is configured to perform a cut through tissue. In some embodiments, a cutting edge of the collapsible cutting portion is shaped and sized to perform a cut through a tissue wall, for example through a tissue layer, surrounding a region of tissue. In some embodiments, the tissue layer is an elastic tissue layer. For example, a tissue layer positioned between a tube, for example a sampling tube, and a target tissue that needs to be sampled. In some embodiments, the tissue wall comprises an abdomen wall, wall of the stomach, the wall of the duodenum, the wall of the intestines, the wall of the bronchial airways, blood vessel walls, GI tract walls, esophagus wall or any wall of anatomical tubes.

Reference is now made to <FIG> depicting a formation of a straight cut through tissue, for example a tissue wall, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a sharp cutting edge of a tissue penetrator collapsible cutting portion is configured to form a thin straight cut through tissue, for example straight cut <NUM>. In some embodiments, a length <NUM> of the straight cut <NUM> is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, shorter or longer cut. In some embodiments, a length <NUM> of the straight cut is equal or larger from a diameter <NUM> of a tube <NUM>, for example a biopsy tube, that needs to penetrate through the straight cut. In some embodiments, a length of the cut <NUM> is selected according to tissue type and/or a diameter of the tube, for example on one side to be long enough to allow penetration of the tube without application of high level of forces on the tube to allow ease of use and without high level of stress on the tissue that may cause tissue ruptures, and/or in the other side not too long, for example to prevent leakage through the cut once the tube is removed from the tissue.

In some embodiments, a thickness of the straight cut <NUM>, for example a distance between two opposite edges of the straight cut, is less than <NUM>, for example less than <NUM>, less than <NUM>, less than <NUM> or any intermediate, smaller or larger value. In some embodiments, a ratio between a maximal width <NUM> of the straight cut <NUM>, for example a maximal distance between two points on the cut, and a thickness of the straight cut is larger than <NUM>:<NUM>, for example larger than <NUM>:<NUM>, larger than <NUM>:<NUM>, larger than <NUM>:<NUM>, larger than <NUM>:<NUM> or any intermediate smaller or higher ratio. In some embodiments, the cutting edge of a tissue penetrator collapsible cutting portion forms a straight cut in a tissue wall that is less elastic and/or has low self-sealing properties, for example the intestine tissue wall or a duodenum tissue wall.

Reference is now made to <FIG> depicting a formation of a curved cut through tissue, for example a tissue wall, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a sharp cutting edge of a tissue penetrator collapsible cutting portion is configured to form a thin curved cut, for example an arc-shaped cut, through tissue, for example curved cut <NUM>. In some embodiments, a length of the curved cut <NUM> is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, shorter or longer cut. In some embodiments, a maximal width of the curved cut, for example a maximal distance between two locations on the curved cut, is larger from a diameter <NUM> of a tube <NUM>, for example a biopsy tube, that needs to penetrate through the curved cut, for example as shown in <FIG>.

According to some exemplary embodiments, a radius of curvature of said curved cut is in a range of <NUM>-<NUM>, for example, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values. In some embodiments, the diameter of curvature of the curved cut <NUM> is at least an outer diameter <NUM> of a tube, for example tube <NUM> that needs to penetrate through the cut <NUM>. In some embodiments, a length of the cut <NUM>, and/or the radius of curvature is selected according to tissue type and/or tissue elasticity and/or a diameter of the tube, for example to allow penetration of the tube without application of high level of forces on the tissue and/or tube that may cause tissue ruptures, and/or to prevent leakage through the cut once the tube is removed from the tissue.

In some embodiments, a thickness, for example a distance between two opposite edges of the curved cut <NUM> is less than <NUM>, for example less than <NUM>, less than <NUM>, less than <NUM>, less than <NUM> or any intermediate, smaller or larger value. In some embodiments, a ratio between a length or a maximal width of the curved cut <NUM> and a thickness of the curved cut is larger than <NUM>:<NUM>, for example larger than <NUM>:<NUM>, <NUM>:<NUM>, larger than <NUM>:<NUM>, larger than <NUM>:<NUM> or any intermediate smaller or higher ratio. In some embodiments, the cutting edge of a tissue penetrator collapsible cutting portion forms a curved cut in a tissue wall that is elastic and/or has high self-sealing properties, for example the stomach tissue wall.

According to some exemplary embodiments, a biopsy tube, for example a biopsy needle is advanced through body tissue to reach a desired target tissue that needs to be sampled directly or through a tissue wall. In some embodiments, a tissue penetrator is coupled to the biopsy tube, for example reversibly coupled, to allow easy penetration through tissue during the advancement of the biopsy tube. In some embodiments, at least part of the tissue penetrator, for example a cutting portion of the tissue penetrator is positioned in front the biopsy tube and facing the tissue.

According to some exemplary embodiments, the cutting portion of the tissue penetrator is shaped and sized to penetrate through tissue while forming a cut which is wider than a maximal width of the biopsy tube that follows the tissue penetrator. Additionally, the cut formed by the cutting has a thickness of less than <NUM>, for example less than <NUM>, less than <NUM> or any intermediate, smaller or larger value.

According to some exemplary embodiments, once a cut is formed, the tissue penetrator is removed from the tissue, for example through the sampling tube lumen. Reference is now made to <FIG>, depicting a tissue sampling process using a tissue penetrator, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a tissue penetrator coupled to a biopsy tube, for example a biopsy needle, is provided at block <NUM>. In some embodiments, an assembly, for example a biopsy assembly, or a kit comprising a tissue penetrator and a biopsy tube is provided at block <NUM>. In some embodiments, the tissue penetrator is disposed within an inner lumen of the biopsy tube. Additionally, at least part of the tissue penetrator, for example a cutting portion of the tissue penetrator extends out from the biopsy tube and positioned 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 tissue.

According to some exemplary embodiments, the biopsy assembly is advanced through body tissue towards a target tissue, at block <NUM>. In some embodiments, the biopsy assembly is advanced by applying axial force on 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, for example using an imaging system, for example ultrasound, x-ray or any other imaging system.

According to some exemplary embodiments, the biopsy assembly reaches a desired target region at block <NUM>. In some embodiments, the biopsy device reaches a desired distance from a target region, for example at a distance of up to <NUM>, up to <NUM>, up to <NUM> or any intermediate, smaller or larger distance from the target region, at block <NUM>.

According to some exemplary embodiments, the tissue penetrator is retracted, at block <NUM>. In some embodiments, retraction of the tissue penetrator decouples the tissue penetrator from the biopsy tube, while optionally keeping the biopsy tube at the same position. In some embodiments, the tissue penetrator is axially retracted relative to the biopsy tube.

According to some exemplary embodiments, at least part of the cutting portion is reshaped, for example collapsed, furled and/or rolled at block <NUM>. In some embodiments, the reshaped cutting portion is inserted into the biopsy tube inner lumen, at block <NUM>. In some embodiments, retraction and/or rotation of the tissue penetrator induce the reshaping, for example collapsing of the cutting edge of the tissue penetrator. In some embodiments, during reshaping the cutting edge acquires a shape and/or size that allows, for example, insertion of the reshaped cutting edge into the biopsy tube inner lumen. In some embodiments, in a reshaped state, a maximal width or diameter of the cutting portion is smaller than a minimal width or minimal diameter of an inner lumen of the biopsy tube. In some embodiments, the reshaping of the cutting portion and insertion of the cutting portion into the biopsy tube lumen are performed simultaneously. Alternatively, the reshaping of the cutting portion and insertion of the cutting portion into the biopsy tube lumen, are performed sequentially, for example by applying forces in different directions and/or in two separate time points.

According to some exemplary embodiments, the tissue penetrator is removed from the inner lumen of the biopsy tube, for example biopsy needle, at block <NUM>. In some embodiments, the tissue penetrator is removed from the inner lumen, for example to allow entry of tissue sample into the inner lumen. In some embodiments, the tissue penetrator is removed by retraction of the tissue penetrator within the inner lumen.

According to some exemplary embodiments, the tissue penetrator is removed completely from the inner lumen of the sampling tube, and optionally outside the body. Alternatively, the tissue penetrator is partly removed, for example to evacuate a predetermined volume of the biopsy tube lumen. In some embodiments, evacuating the predetermined volume allows, for example, to sample a predetermined tissue sample volume.

According to some exemplary embodiments, body tissue is sampled at block <NUM>. In some embodiments, during body tissue sampling the biopsy tube, for example 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, during the advancement of the biopsy tube, for example by rotation of the biopsy tube, a tissue sample enters into a volume of the biopsy tube inner lumen, for example a volume evacuated at block <NUM> by removal of the tissue penetrator.

Reference is now made to <FIG> and <FIG> depicting a biopsy assembly comprising a biopsy tube and a tissue penetrator, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a biopsy assembly, for example assembly <NUM>, comprises a tissue penetrator <NUM> and a biopsy tube <NUM>. In some embodiments, the tissue penetrator <NUM> is reversibly coupled to the biopsy tube <NUM>. In some embodiments, for example as shown in <FIG> and <FIG>, at least part of the tissue penetrator is disposed within an inner lumen <NUM> of the biopsy tube <NUM>.

According to some exemplary embodiments, a tissue penetrator, for example tissue penetrator <NUM> comprises an elongated body <NUM> and a cutting portion <NUM> located at a distal section of the elongated body, for example a section that is closer to body tissue. Optionally, the cutting portion is located at a distal end of the elongated body, for example an end of the elongated body closer to body tissue. Optionally, the tissue penetrator comprises a tip <NUM>, for example a conical tip. In some embodiments, the tip <NUM> is at least partly beveled. In some embodiments, the tip <NUM> is shaped and sized to allow easy penetration through body tissue, for example as the tissue penetrator advances through body tissue. In some embodiments, the tip <NUM> is part of the cutting portion <NUM>. Alternatively, the tip <NUM> is located distally to the cutting portion <NUM>.

According to some exemplary embodiments, the cutting portion <NUM>, for example a collapsible cutting portion, comprises a cutting edge <NUM>. In some embodiments, the cutting edge <NUM> is located on a distal surface of the cutting portion <NUM> facing a tissue. Optionally, the cutting edge <NUM> is a leading edge of the cutting portion <NUM>.

According to some exemplary embodiments, the cutting edge <NUM> is sharp. Additionally or alternatively, in some embodiments, the cutting portion is thin, for example has a thickness of less than <NUM>, for example less than <NUM>, less than <NUM> or any intermediate, smaller or larger value. In some embodiments, a length of the cutting edge <NUM> is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values. In some embodiments, a ratio between a length or maximal width, for example a maximal distance between two points on the cutting edge, and a thickness of the cutting edge is at least <NUM>:<NUM>, for example at least <NUM>:<NUM>, at least <NUM>:<NUM> or any intermediate, smaller or larger ratio value. In some embodiments, a ratio between a length of the cutting edge <NUM> and the maximal width/ diameter of the cutting edge is at least <NUM>:<NUM>, for example at least <NUM>:<NUM>, at least <NUM>:<NUM> or any intermediate, smaller or larger ratio.

According to some exemplary embodiments, the cutting edge <NUM> is planar, for example straight. In some embodiments, the planar cutting edge is used to perform a straight cut, for example as described in <FIG>.

According to some exemplary embodiments, the cutting edge <NUM> is curved. In some embodiments, the curved cutting edge has a radius of curvature in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values.

According to some exemplary embodiments, a specific tissue penetrator with a specific type of cutting edge is selected according to the tissue type that needs to be cut, for example a tissue penetrator with a planar cutting edge is selected, when a cut needs to be performed in a tissue wall with low elasticity, for example a tissue wall of the intestine or the duodenum. Alternatively, a tissue penetrator with a curved cutting edge is selected, when a cut needs to be performed in an elastic tissue, for example a wall of the stomach. Alternatively or additionally, a specific type of penetrator with a specific cutting edge is selected according to the external diameter of the tube that needs to penetrate through the formed cut.

According to some exemplary embodiments, the elongated body <NUM> comprises a shaft. In some embodiments, the elongated body <NUM> is flexible and bendable, for example to allow bending while at least one of, the assembly <NUM>, the biopsy tube <NUM> and/or the tissue penetrator <NUM> is steered towards a desired target region in the body. In some embodiments, the elongated body is bendable in at least <NUM>° degrees, for example at least <NUM>°degrees, at least <NUM>°degrees, at least <NUM>° degrees or any intermediate, smaller or larger angle. In some embodiments, the elongated body is formed from stainless steel, steel, steel alloy, e.g. cobalt chromium, a super elastic alloy, e.g. NiTi, or a shape memory alloy.

According to some exemplary embodiments, a width <NUM> of the elongated body <NUM>, is up to <NUM>%, for example up to <NUM>%, up to <NUM>% or any intermediate, smaller or larger percentage value, of the width <NUM> of the inner lumen <NUM>, for example to allow the tissue penetrator <NUM> to support the biopsy tube <NUM> during navigation to a desired target region. In some embodiments, a thickness of a wall <NUM> surrounding said inner lumen <NUM> is at least <NUM>%, for example at least <NUM>%, at least <NUM>%, at least <NUM>% or any intermediate, smaller or larger percentage value of the inner width or the inner diameter of the inner lumen <NUM> of the biopsy tube.

According to some exemplary embodiments, a maximal width or a maximal diameter of the tissue penetrator body <NUM> is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values. In some embodiments, a maximal width or a maximal diameter of the inner lumen <NUM> is larger in at least <NUM>, for example at least <NUM>, at least <NUM>, at least <NUM> or any intermediate, smaller or larger value, from the maximal diameter of the tissue penetrator body.

According to some exemplary embodiments, the cutting portion <NUM> is a re-shapeable cutting portion and is configured to move from an expanded state to a collapsed state, for example as described in <FIG>. In some embodiments, in an expanded state, for example as shown in <FIG>, the cutting portion is located outside and distal to the biopsy tube <NUM>. In some embodiments, the cutting portion <NUM> is mechanically connected to a portion of the body <NUM> extending out from the biopsy tube lumen <NUM>, for example through a distal opening <NUM>. Alternatively, the cutting portion <NUM> is an integral part of the body <NUM>.

According to some exemplary embodiments, in an expanded state, for example as shown in <FIG>, a maximal width <NUM> of the cutting portion <NUM> is larger than a maximal width <NUM> or a maximal diameter of the inner lumen <NUM>. In some embodiments, in the expanded state, a maximal width <NUM> of the cutting portion <NUM> is larger than a maximal width or a maximal diameter of the inner lumen distal opening <NUM>. In some embodiments, the maximal width <NUM> of the cutting portion <NUM> is in a range of <NUM>-<NUM>.

According to some exemplary embodiments, in an expanded state the cutting portion comprises a single continuous distal cutting edge, facing tissue. Alternatively, the cutting portion comprises two or more distally extending sections, each having a distal cutting edge facing tissue. Alternatively, the cutting portion comprises two or more distally extending sections of a single continuous cutting edge. In some embodiments, the cutting portion distally extends to form the tip <NUM>.

According to some exemplary embodiments, the cutting portion is reshaped to enter the inner lumen <NUM> of the biopsy tube, for example as shown in <FIG>. In some embodiments, reshaping of the cutting portion is induced by retracting and/or rotating the tissue penetrator <NUM>, for example the tissue penetrator body <NUM>. In some embodiments, the tissue penetrator body is retracted and/or rotated from outside the body. In some embodiments, in a reshaped, for example a collapsed state, a maximal width or diameter of the cutting portion is smaller than an internal width or diameter of the inner lumen <NUM>, for example to allow removal of the tissue penetrator <NUM> from the body through the biopsy tube inner lumen, for example as described at block <NUM> of <FIG>.

According to some exemplary embodiments, retraction and/or rotation of the tissue penetrator body <NUM> induce furling or rolling of at least part of the cutting portion <NUM>, for example to acquire a desired shape which has smaller dimensions, for example width or diameter, relative to the dimensions of the inner lumen <NUM>. Alternatively or additionally, retraction and/or rotation of the tissue penetrator body <NUM> induce at least part of the cutting portion to collapse, for example to acquire the desired shape. In some embodiments, retraction and/or rotation of the tissue penetrator body <NUM> induce two or more ends of the cutting portion to bend until an overlap is formed.

Reference is now made to <FIG> depicting coupling between a tissue penetrator and a biopsy tube, according to some exemplary embodiments of the invention.

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 removal of the tissue penetrator prior to or during tissue sampling.

According to some exemplary embodiments, coupling of the tissue penetrator to the biopsy tube allows the biopsy tube to support the distally extending cutting against external pressure applied on the cutting portion, for example during the navigation. In some embodiments, for example as shown in <FIG>, during navigation, the cutting portion <NUM> is pressed against a distal end of the biopsy tube body <NUM> that surrounds, for example, an edge of the opening <NUM> by forces applied by the tissue. In some embodiments, the cutting portion is shaped and configured to be pressed against the body <NUM> without collapsing.

According to some exemplary embodiments, a minimal thickness of a wall of said biopsy tube body is at least <NUM>%, for example at least <NUM>%, at least <NUM>%, at least <NUM>% or any intermediate, smaller or larger percentage value, of the inner diameter of the biopsy tube. In some embodiments, a minimal thickness of a wall of said biopsy tube body is at least <NUM>, for example at least <NUM>, at least <NUM>, at least <NUM> or any intermediate, smaller or larger value.

According to some exemplary embodiments, for example as shown in <FIG>, the coupling between the tissue penetrator <NUM> and the biopsy tube <NUM> is generated by a coupler <NUM> located at a proximal section <NUM> of the biopsy tube <NUM>. In some embodiments, the coupler <NUM> mechanically couples the biopsy tube <NUM> and the tissue penetrator <NUM> during navigation towards a target region. In some embodiments, the coupler fixes a position of the tissue penetrator <NUM> relative to the biopsy tube <NUM> in an axial direction, while optionally allowing rotation of the biopsy tube and/or the tissue penetrator relative to each other. In some embodiments, the coupler <NUM> comprises a reversible lock, for example a reversible interlocking mechanism. In some embodiments, forces applied on the cutting portion press the tissue penetrator against the interlocking mechanism. In some embodiments, the interlocking mechanism transfers at least part of the applied force to the biopsy tube.

According to some exemplary embodiments, for example as shown in <FIG>, release of the interlocking mechanism allows, for example reshaping of the cutting portion and/or retraction of the tissue penetrator <NUM> through the lumen of the biopsy tube <NUM>. In some embodiments, decoupling of the tissue penetrator <NUM> from the biopsy tube <NUM> is irreversible. Optionally, the coupler <NUM> is part of a mechanism for rotation and/or retraction of the tissue penetrator to allow, for example reshaping of the cutting portion.

According to some exemplary embodiments, a biopsy assembly, comprising a biopsy tube and a tissue penetrator is advanced through body tissue towards a desired target region. In some embodiments, at least part of the tissue penetrator, for example a cutting portion, is located distally to the biopsy tube, and is shaped and sized to penetrate and perform a cut, as the assembly advances towards the target region. In some embodiments, the cut formed by the cutting portion allows, for example easy penetration of the biopsy tube located proximally to the cutting portion, through the tissue. Reference is now made to <FIG>, describing penetration through tissue, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a biopsy assembly <NUM> comprises a tissue penetrator <NUM> and a biopsy tube <NUM>. In some embodiments, prior to penetration through tissue, the tissue penetrator body <NUM> is located within an inner lumen <NUM> of the biopsy, and a cutting portion <NUM> of the tissue penetrator <NUM> connected to the body <NUM>, distally extends out from the biopsy tube <NUM>. In some embodiments, when the cutting portion extends out from the biopsy tube, the cutting portion is in an expanded state, where a maximal width of the cutting portion is larger or has a width similar to the biopsy tube outer width, for example outer diameter.

According to some exemplary embodiments, the tissue penetrator comprises a distal tip, for example a sharp distal tip <NUM>, located distally to the cutting portion. In some embodiments, the distal tip is an integral part of the cutting portion <NUM>. Alternatively, the distal tip is an integral part of the body <NUM>, for example in embodiments in which the body extends out from the biopsy tube and is connected to the cutting portion.

According to some exemplary embodiments, for example as shown in <FIG>, as the assembly <NUM> advances into and through tissue <NUM>, the tip <NUM> penetrates through the tissue <NUM>, while the expanded cutting portion <NUM> forms a thin cut <NUM> which is wider or has a width similar to the width of the proximally positioned biopsy tube <NUM>. In some embodiments, the tissue applies force on the cutting portion, as the tissue penetrator advances through the tissue. In some embodiments, the force applied on the cutting portion pushes the cutting portion against the biopsy tube, which structurally supports the cutting portion without inducing reshaping, for example collapse of the cutting portion. Alternatively, a coupler, for example coupler <NUM> shown in <FIG>, structurally supports the tissue penetrator body against the forces applied on the cutting portion <NUM>.

According to some exemplary embodiments, for example as shown in <FIG>, once the assembly <NUM> has reached a desired target region in the tissue, the tissue penetrator <NUM> is removed from the tissue <NUM>. In some embodiments, when the tissue penetrator <NUM> is removed, the biopsy tube <NUM> remains at the same position. In some embodiments, the cutting portion <NUM> is reshaped, for example collapsed, for example to acquire a shape and/or size that can fit into the inner lumen <NUM> of the biopsy tube <NUM>.

According to some exemplary embodiments, for example as shown in <FIG>, the cutting portion <NUM> is reshaped, for example collapsed, by retraction and/or rotation of the body <NUM>. In some embodiments, retraction of the tissue penetrator body <NUM> causes the cutting portion to collapse, for example during and/or prior to entry into the biopsy tube lumen <NUM>.

According to some exemplary embodiments, the tissue penetrator is removed from the body, for example as shown in <FIG>. In some embodiments, the biopsy tube is advanced into the tissue, and at least partly through the cut <NUM>, for example as shown in <FIG>. In some embodiments, the cut <NUM> allows, for example, easy entry of the biopsy tube through the tissue wall <NUM>. Alternatively or additionally, the cut shape and/or size allows self-sealing by the tissue, for example to prevent leakage through the cut in the tissue wall when the biopsy tube is retracted.

According to some exemplary embodiments, a tissue penetrator comprises longitudinal axis, a distal section shaped and sized to contact a tissue, and a proximal section. In some embodiments, a collapsible cutting portion, configured to reshape and acquire a narrow shape, for example a narrow shape that fits into an internal lumen of a biopsy tube, is located at the distal section. In some embodiments, the cutting portion comprises a cutting edge on an external surface of the cutting portion facing a tissue. In some embodiments, an elongated body connected to the cutting portion is located at the proximal section. Optionally, the cutting portion is integrated with the elongated body.

According to some exemplary embodiments, the cutting portion is reshaped by forces applied by a biopsy tube, in which the tissue penetrator body is disposed, on the cutting portion. In some embodiments, the cutting portion, is bendable, for example to allow collapse of the cutting portion. Optionally, the cutting portion is elastic, for example to allow collapse of the cutting portion and return to a previous expanded shape. Reference is now made to <FIG>, depicting reshaping of a cutting portion, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a tissue penetrator, for example tissue penetrator <NUM> comprises a proximal elongated body <NUM>, a distal cutting portion <NUM> connected to the elongated body, and a longitudinal axis <NUM>. In some embodiments, the tissue penetrator <NUM> is disposed at least partly within an inner lumen <NUM> of a biopsy tube <NUM>. In some embodiments, for example, as shown in <FIG>, the cutting portion distally extends at least partly from the inner lumen <NUM>.

According to some exemplary embodiments, a cross section or a projection of the cutting portion, for example cutting portion <NUM> is a rhombus, a deltoid, a deltoid with curved or angled corners or a diamond shape. In some embodiments, the cutting portion is a collapsible cutting portion, and configured to inwardly collapse towards the longitudinal axis <NUM> of the tissue penetrator. In some embodiments, the cutting portion is configured to inwardly collapse, in response to an inward force applied on opposite sides of the cutting portion <NUM>, for example by the biopsy tube <NUM>, at one or more contact points, for example contact points <NUM> and <NUM> between the cutting portion <NUM> and the biopsy tube <NUM>.

According to some exemplary embodiments, for example as shown in <FIG>, the inward collapse reshapes the cutting portion <NUM> to have a maximal width smaller than a minimal width of the biopsy tube inner lumen <NUM>.

According to some exemplary embodiments, during the advancement of the tissue penetrator <NUM> and the biopsy tube <NUM> through tissue, the biopsy tube <NUM> supports the cutting portion <NUM>, at one or more contact points, against force applied by the tissue on the cutting portion <NUM>. In some embodiments, the force applied by the tissue is lower than a force value needed to induce reshaping. In some embodiments, the cutting portion shape is configured to resist a force value of up to <NUM>-<NUM> Newton (N), for example <NUM>-2N, <NUM>-3N <NUM>-5N or any intermediate, smaller or larger range of values, without reshaping, for example by leaning against the biopsy tube <NUM>. In some embodiments, retraction of the tissue penetrator exceeds this force value, leading to reshaping of the cutting portion.

According to some exemplary embodiments, for example as shown in <FIG>, a cutting portion <NUM> has a cross-section shaped as a triangle, in which a base of the triangle <NUM> leans against the biopsy tube body <NUM>, for example during advancement through body tissue.

According to some exemplary embodiments, a wall <NUM> of the tissue penetrator is positioned at angle of less than <NUM> degrees, for example less than <NUM> degrees, less than <NUM> degrees or any intermediate, smaller or larger degree between the tissue penetrator wall and the tissue penetrator body <NUM>. In some embodiments, the wall <NUM> leans against the biopsy tube <NUM>, for example to support the cutting portion <NUM> against forces applied by tissue on the cutting portion as the cutting portion advances through the tissue, without causing reshaping of the cutting portion.

According to some exemplary embodiments, retraction of the body <NUM>, applies force by the biopsy tube <NUM> on the cutting portion <NUM>, leading to an inward collapse of the cutting portion <NUM>, for example towards the longitudinal axis <NUM>. In some embodiments, for example as shown in <FIG>, in a collapsed state, a maximal width of the cutting portion is smaller than a minimal width of the biopsy tube inner lumen <NUM>.

According to some exemplary embodiments, for example as shown in <FIG>, a tissue penetrator comprises a distal cutting portion <NUM> connected to a proximal body <NUM>, or is integrated with the body <NUM>. In some embodiments, the tissue penetrator <NUM> comprises a stopper <NUM>, located proximal to the cutting portion <NUM>, for example between the cutting portion <NUM> and a biopsy tube body <NUM>, when the cutting portion is in an expanded state. In some embodiments, during the advancement of the tissue penetrator <NUM> through tissue, forces applied by the tissue on the cutting portion <NUM> push the stopper <NUM> against the body <NUM>.

According to some exemplary embodiments, the stopper <NUM> is configured to resist pressure applied by the biopsy tube body <NUM> on the tissue penetrator during advancement through tissue, without causing the cutting portion <NUM> to reshape, for example collapse. In some embodiments, the stopper is configured to prevent direct contact between the biopsy tube body <NUM> and the cutting portion <NUM>. In some embodiments, for example during the advancement through tissue, the stopper is reversibly mechanically coupled to the biopsy tube body <NUM>. In some embodiments, the stopper is coupled to the tissue penetrator body <NUM>.

According to some exemplary embodiments, retraction of the tissue penetrator <NUM>, for example as shown in <FIG> applies a force of the stopper <NUM> which is larger than a force the stopper <NUM> can resist. In some embodiments, the force applied on the stopper <NUM> during retraction of the tissue penetrator <NUM> relative to the biopsy tube <NUM>, deforms the stopper <NUM>. In some embodiments, deformation of the stopper leads to direct contact between the biopsy tube <NUM> and the cutting portion <NUM>, for example a collapsible cutting portion, causing the cutting portion <NUM> to collapse, for example as described in <FIG>. In some embodiments, the stopper is configured to resist pressure of up to <NUM>-5N, for example <NUM>-2N, <NUM>-3N. <NUM>-4N, <NUM>-5N or any intermediate, smaller or larger range of values.

Reference is now made to <FIG> depicting 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 invention.

According to some exemplary embodiments, a tissue penetrator, for example a tissue penetrator <NUM> comprising a cutting portion <NUM>, for example a collapsible portion. In some embodiments, at least one external surface of the cutting portion <NUM> is a non-planar surface, for example a curved or an angled external surface. In some embodiments, at least one external surface of the cutting portion <NUM> facing a tissue, for example tissue wall <NUM> is non-planar, for example surface <NUM>.

According to some exemplary embodiments, an external surface of the cutting portion <NUM> facing a tissue, for example surface <NUM> is positioned at angle <NUM> larger than <NUM> degrees, for example at an angle larger than <NUM> degrees, larger than <NUM> degrees, larger than <NUM> degrees, larger than <NUM> degrees or any intermediate, smaller or larger angle between the surface <NUM> and tissue wall <NUM>. In some embodiments, an angle larger than <NUM> degrees between an external surface of the cutting portion facing the tissue and the tissue allows, for example to penetrate into the tissue while applying low axial forces by the cutting portion <NUM> on the tissue <NUM>.

According to some exemplary embodiments, an external surface of the cutting portion <NUM>, for example surface <NUM> facing a biopsy tube <NUM> in which the tissue penetrator is disposed, is positioned at an angle relative to the biopsy tube <NUM>. In some embodiments, an angle <NUM> between the biopsy tube <NUM> and the surface <NUM> is larger than <NUM> degrees, for example larger than <NUM> degrees, larger than <NUM> degrees, larger than <NUM> degrees, larger than <NUM> degrees or any intermediate, smaller or larger angle between the surface <NUM> and the biopsy tube <NUM>. In some embodiments, an angle larger than <NUM> degrees between an external surface of the cutting portion facing the biopsy tube and the tissue biopsy tube allows, for example, to collapse the cutting portion by applying relatively low axial forces on the penetrator body <NUM> by the biopsy tube <NUM>, for example by retracting the penetrator body into an inner lumen of the biopsy tube.

Reference is now made to <FIG>, depicting a tissue penetrator with curved lateral walls, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a tissue penetrator, for example tissue penetrator <NUM> comprises a cutting portion <NUM>, for example a collapsible cutting portion, connected to an elongated body <NUM>. In some embodiments, the cutting portion <NUM> comprises a distal tip, for example distal tip <NUM> connected to the elongated body <NUM> via lateral surfaces <NUM> and <NUM>, for example side surface. In some embodiments, for example as shown in <FIG>, the lateral surfaces <NUM> and <NUM> are curved, for example non-angled. In some embodiments, the lateral surfaces are curved, when the cutting portion is in an expanded state, for example when the cutting portion extends out from the inner lumen of the biopsy tube body <NUM>. Optionally, the distal tip of the cutting portion is curved. Optionally, an external edge of the cutting portion is entirely curved. Alternatively, at least part of the external edge is curved.

Reference is now made to <FIG> depicting a tissue penetrator with a curved cutting portion, according to some exemplary embodiments.

According to some exemplary embodiments, a tissue penetrator <NUM> comprises an elongated body <NUM> having a proximal section <NUM> and a distal section <NUM>. In some embodiments, the elongated body <NUM> comprises an elongated shaft. In some embodiments, the shaft is flexible, for example to allow bending of the tissue penetrator while advancing through a sleeve, for example an endoscope. In some embodiments, the elongated shaft comprises a distal tip <NUM>. In some embodiments, the distal tip <NUM> is closed, for example to prevent penetration of tissue into the shaft. Optionally, the distal tip <NUM> is beveled. Optionally or additionally, the distal tip <NUM> is at least partly sharpened, for example to allow easy penetration through tissue.

According to some exemplary embodiments, a cutter, for example a cutting portion <NUM> is mechanically connected to a distal section <NUM> of the elongated body <NUM>, for example to a distal section of the shaft. In some embodiments, the distal tip <NUM> is positioned distally to the cutting portion <NUM>. In some embodiments, the cutting portion <NUM> is at least partly curved.

According to some exemplary embodiments, the cutting portion <NUM> has a curved surface, which is curved around a longitudinal axis of the tissue penetrator, for example around a longitudinal axis of the elongated body <NUM>. In some embodiments, a maximal length of the curved surface perpendicular to the elongated body is larger 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 body <NUM>. In some embodiments, a maximal arc length of the curved surface is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values. In some embodiments, a ratio between an overall width of the curved surface <NUM> of the cutting portion relative to the width or diameter of elongated body <NUM>, is in a range between a <NUM>:<NUM> ratio and a <NUM>:<NUM> ratio, respectively. In some embodiments, a maximal length of the cutting portion <NUM> along the longitudinal axis of the body <NUM> is in a range of <NUM>-<NUM>, for example <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM> or any intermediate, smaller or larger range of values.

According to some exemplary embodiments, an external edge of the cutting portion <NUM> which extends on both sides of the elongated body <NUM> is at least partly sharpened, for example to allow cutting of tissue as the tissue penetrator advances axially into the tissue. In some embodiments, a maximal thickness <NUM> of the cutting portion <NUM>, for example as shown in <FIG>, is smaller than <NUM>, for example smaller than <NUM>, smaller than <NUM>, smaller than <NUM> or any intermediate, smaller or larger value. In some embodiments, the thickness <NUM> is calculated by reducing a width of the body <NUM> from the width of the internal lumen <NUM>, and dividing the result in at least <NUM>, for example at least <NUM>, at least <NUM> or any intermediate, smaller or larger value.

According to some exemplary embodiments, for example as shown in <FIG>, the cutting portion <NUM> is coupled to the elongated body <NUM>, at one or more contact points along the body <NUM>. In some embodiments, the cutting portion <NUM> is coupled to the elongated body by welding at one or more welding points, for example welding points <NUM> and <NUM>. Alternatively, the cutting portion is coupled to the elongated body by soldering, gluing, crimping and any other bonding options of metal parts.

According to some exemplary embodiments, for example as shown in <FIG>, the tissue penetrator is shaped and sized to be positioned at least partly within a biopsy tube <NUM>, which is optionally a biopsy needle. In some embodiments, the tissue penetrator, for example the cutting portion <NUM> and the body <NUM> extend distally from the tube <NUM>, for example through a distal opening <NUM> of the tube <NUM>. In some embodiments, for example as shown in <FIG>, a maximal width of the cutting portion <NUM>, for example when the cutting portion is expanded, is smaller or equal to the external width <NUM> of the biopsy tube <NUM>. In some embodiments, when the cutting portion is expanded, a maximal width of the cutting portion is larger than the width of the biopsy tube inner lumen.

Reference is now made to <FIG>, depicting a cutting portion in a collapsed state, for example in a folded state, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, in a collapsed state, the tissue penetrator is inserted into the inner lumen <NUM> of the biopsy tube <NUM>. In some embodiments, the cutting portion <NUM> is folded, for example at least partly around the body <NUM>. In some embodiments, the cutting portion <NUM> is flexible, for example to allow folding in a collapsed state. In some embodiments, the cutting portion <NUM> is irreversible collapsible, for example the cutting portion <NUM> cannot return to a previous shape once inwardly collapsed. Optionally, the cutting portion is also elastic, for example to allow return to a previous expanded state.

According to some exemplary embodiments, in a collapsed state, for example as shown in <FIG>, the cutting portion contacts the inner surface of the biopsy tube lumen <NUM>. Optionally, in a collapsed state, sharpened edges of the cutting portion are positioned at a distance from the inner surface of the lumen <NUM>, for example to prevent damage to the surface as the tissue penetrator moves within the lumen <NUM>.

Reference is now made to <FIG> depicting collapse of a curved cutting portion, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, for example as shown in <FIG>, a curved cutting portion <NUM> is coupled to a tissue penetrator body, for example shaft <NUM>. In some embodiments, in an expanded state shown in <FIG>, a maximal width <NUM> of the cutting portion <NUM> is larger than a width <NUM> of a biopsy tube <NUM> inner lumen <NUM>, in which the tissue penetrator is at least partly located. In some embodiments, in an expanded state, the cutting portion extends at least partly out from the inner lumen <NUM>.

According to some exemplary embodiments, for example shown in <FIG>, the cutting portion <NUM> is configured to collapse, for example to fold, to acquire a width <NUM> which is smaller than the width of the inner lumen <NUM>. In some embodiments, the cutting portion is elastic enough to bend inwardly, for example to acquire a width which is smaller than the inner lumen <NUM> width.

Alternatively, for example as shown in <FIG>, a curved cutting portion <NUM> coupled to tissue penetrator body <NUM> is configured to furl, for example to roll, at least partly within the lumen <NUM>. In some embodiments, when the cutting portion <NUM> is at least partly rolled, two opposite ends, for example opposite ends <NUM> and <NUM> overlap and optionally contact each other. Alternatively, two opposite ends of the cutting portion are at least partly rolled without overlap, for example as shown in <FIG>.

Reference is now made to <FIG>, depicting a tissue penetrator with an integrated cutting portion, according to some exemplary embodiments of the invention.

According to some exemplary embodiments, a tissue penetrator <NUM> comprises a proximal section <NUM> and a distal section <NUM>. In some embodiments, the tissue penetrator comprises an elongated body <NUM> at the proximal section, and a cutting portion <NUM> at the distal section <NUM>. In some embodiments, the cutting portion <NUM> is integrated with the body, for example formed from the same sheet or layer of material.

According to some exemplary embodiments, the body <NUM> and cutting portion <NUM> are formed from a single layer of material, for example from a sheet of steel, stainless steel, steel alloy e.g. cobalt chromium, or super elastic alloy, a shape memory alloy, for example Nitinol. In some embodiments, the body <NUM> is formed by bending the layer to form a tubular shape, for example an enclosed tube, which is shaped and sized 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 body that is shaped and sized to be positioned inside the biopsy tube has a fixed width or diameter, which is smaller than the width or diameter of the biopsy tube. Additionally, the external surface of the body <NUM> is smooth, for example to prevent damage to the inner surface of the biopsy tube.

According to some exemplary embodiments, the cutting portion is formed by bending the layer of material to form a concave shape, with optionally a distally extending tip <NUM>. In some embodiments, a maximal width of the cutting portion <NUM> is larger than a maximal width of the body <NUM>.

According to some exemplary embodiments, a body <NUM> comprises a window or opening, for example opening <NUM>, for example to allow to lower the retraction force.

It is expected that during the life of a patent maturing from this application many relevant biopsy tubes will be developed; the scope of the term biopsy tube is intended to include all such new technologies a priori.

As used herein with reference to quantity or value, the term "about" means "within ± <NUM> % of".

The terms "comprises", "comprising", "includes", "including", "has", "having" and their conjugates mean "including but not limited to".

As used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

Throughout this application, embodiments of this disclosure may be presented with reference to a range format. For example, description of a range such as "from <NUM> to <NUM>" should be considered to have specifically disclosed subranges such as "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", "from <NUM> to <NUM>", etc.; as well as individual numbers within that range, for example, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

Claim 1:
A biopsy assembly (<NUM>), comprising:
a biopsy tube (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) defining a lumen (<NUM>, <NUM>, <NUM>, <NUM>); a tissue penetrator (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) having a distal tip (<NUM>, <NUM>, <NUM>, <NUM>) shaped to penetrate through tissue, wherein said tissue penetrator (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is positioned within said lumen (<NUM>, <NUM>, <NUM>, <NUM>) and comprising:
an elongated flexible body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) shaped and sized to move within said biopsy tube lumen (<NUM>, <NUM>, <NUM>, <NUM>);
a collapsible distal cutting portion (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) coupled to said body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and extending out from said lumen (<NUM>, <NUM>, <NUM>, <NUM>) in an expanded state in front of said biopsy tube (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), and configured to collapse to a width smaller than an inner width of said lumen (<NUM>, <NUM>, <NUM>, <NUM>) in a collapsed state,
wherein said collapsible distal cutting portion (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprises a distal sharp cutting edge (<NUM>, <NUM>, <NUM>), configured to perform a thin cut through said tissue, wherein in an expanded state a maximal width of said collapsible distal cutting portion (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is larger than an inner width or an inner diameter of said biopsy tube lumen;
and characterised in that said collapsible distal cutting portion (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is coupled to a distal end of said body (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>);
and said distal tip (<NUM>, <NUM>, <NUM>, <NUM>) is an integral part of said collapsible distal cutting portion (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>).