All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Described herein are apparatuses and methods for biopsying body vessels having small lumen, such as Fallopian tubes. In particular, described herein are apparatuses (e.g., systems and devices) and methods that evert a textile biopsying member to sample tissue from a vessel or conduit such as the fallopian tubes without applying substantial shear force.
A biopsy is the removal of tissue in order to examine it for disease. Usually, a biopsy is performed to examine tissue for disease. Biopsies are frequently used to diagnose cancer, but they can help identify other conditions such as infections and inflammatory and autoimmune disorders. They may also be done to match organ tissue before a transplant and to look for signs of organ rejection following a transplant. The tissue samples can be taken from any part of the body, including small channels, ducts and tubes. Biopsies are performed in many areas of the body and for many reasons. In particular, biopsies may be taken from any duct, channel, or vessel within the body, such as (but not limited to) the fallopian tubes (e.g., uterine tubes).
For example, an endometrial biopsy may be used when looking for the cause of abnormal uterine bleeding, to examine the lining of the uterus and to diagnose cancer. This type of biopsy can be performed by using a small needle-like device to capture a sample or by using a tool to scrape some of the lining for examination. Ovarian cancer is a significant disease in women. Early detection of ovarian cancer may be difficult due to a lack of effective screening tests, such that ovarian cancer may not be diagnosed until the disease has reached advanced stages, limiting treatment options. Screening for ovarian cancer may typically include a surgical procedure for obtaining cell samples for diagnosis. For example, because the ovaries are intra-abdominal, laparoscopic or open surgery (laparotomy) may be performed to access the ovaries. Any surgical procedure increases a risk to the patient, including but not limited to experiencing an adverse reaction, and/or requiring significant recovery time. Additionally, an ovary biopsy may expose the patient to additional risk of potentially spreading diseased (e.g., cancerous) cells.
Thus, there exists a need for devices and processes to allow samples to be obtained from body ducts and tubes, such as the fallopian tubes, for evaluation of tissue, including but not limited to the detection of ovarian cancer, in a less invasive and controlled fashion and, particularly without the need for a skin incision.
Described herein biopsy apparatuses configured to taking biopsy (e.g., tissue, cell, etc.) samples from within a small-diameter lumen of a body. These biopsy apparatuses include devices, which may be referred to herein as small-tube biopsy devices, and system including them. These apparatuses may gently remove a biopsy sample from the wall(s) of a vessel lumen without risk of rupture of the vessel and with minimal irritation of the vessel.
In general, these apparatuses may include an inner tubular member that is concentrically and movably held within an outer tubular member. A biopsy collector can be deployed from the distal end of the apparatus and may be expandable so that, when the inner member is moved relative to the outer member by a control on a proximal handle, the biopsy collector expands outward into and against the walls of the lumen.
For example, described herein are small-tube biopsy devices having: an inner member coaxially arranged within an outer member, so that the inner member may move axially in a distal and proximal direction relative to the outer member; a biopsy collector comprising a knitted or woven textile configured to collect biopsy tissue, wherein the biopsy collector is connected at a first end to the inner member and at a second end to the outer member; and a proximal handle coupled to the inner member and the outer member and configured to move the inner member axially relative to the outer member to expand the biopsy collector.
The knitted or woven textile may generally be configured for biopsy collection. For example, the knitted or woven textile may have a roughness sufficient for removing tissue, and/or a porosity that is configured to enhance collection of biopsy tissue.
In addition, in any of these variations described herein, the device may initially be configured so that knitted or woven textile forming the biopsy collector (e.g., the biopsy collector) is pre-loaded for deployment within the inside of outer member; all or the majority of it (e.g., greater than 75%, greater than 80%, greater than 85%, greater than 90%, greater than 95%, etc.) is initially pre-loaded within the outer member, with the inner member retracted proximally. The knitted or woven textile may configured to have a sufficient column strength to allow it to be pushed distally out of the outer member (which may be a flexible tube, such as a cannula, or coil) so that it may evert as it passes beyond the distal end of the outer member. The knitted or woven textile may be configured to prevent it from rolling against the distal end of the outer member, which may otherwise contaminate the biopsy collector and/or may dislodge any biopsy material when the knitted or woven textile is withdrawn back into the outer member. The knitted or woven material may be configured to prevent it from rolling against the distal end of the outer member in one or more of a variety of ways, including by attaching one end or end region of the knitted or woven material to an inner lumen wall of the outer member (including attaching it in an inverted configuration relative to the attachment of the other end or end region of the knitted or woven material that is attached to the inner member. Alternatively or additionally, the knitted or woven material may be biased to roll and invert when driven distally. Alternatively or additionally, the knitted or woven material may be configured to be formed having have a specified range of filament shapes, sizes, count, weave angle, etc., as described herein. Filaments shapes can be round or flat, the size of the filaments are and number of filaments may be related to the internal diameter of the delivery system (e.g., the outer member). A smaller diameter delivery system, such as an outer member configured as a catheter or coil having an inner diameter (ID) of 1.5 mm or less may be used with an everting biopsy collector (e.g., which may preferably be a textile structure) formed from smaller filaments, such as wire filament or combined wire/polymer filaments, such as filaments between 0.001″ to 0.05″. The wire filaments may be formed, e.g., of Nitinol, spring steel and it's alloys, etc. In addition, the number of filaments per cross sectional area may be low.
In general the stability of the everted biopsy collector (e.g., textile structure) may benefit from higher column force resistance. Higher column force may provide a stable structure to aid in pushing the textile while everting. Thus, the biopsy collector may be configured to be a formed of a “stacked” high density knit, high density weave, and the like, typically having a low braid angle.
As mentioned, the knitted or woven textile may be configured to collect and/or retain the biopsy tissue. For example, the knitted or woven textile may have pores that are within a range of, e.g., between about 0.002″ and 0.05″. Variations of the biopsy collector that provide a higher radial force may expand the textile structure outward into the vessel wall increasing collection efficiency. As described in greater detail below, this may also allow these apparatuses to open a closed-off biological lumen/vessel and/or help maintain patency of the lumen/vessel. Touching wall and creating a shear force at the desired time (e.g., after deployment, but preferably not before) may also greatly improve sampling. Increasing radial force may be accomplished by one or more of: forming the biopsy collector from using large wire diameters/cross section, using more wires (e.g., greater knit, weave, braid per given diameter), the materials used for the wires (e.g., Nitinol, Steel, Elgiloy, MP35n, etc., generally stiffer may be preferred), and finally the annealed shape of the final everted biopsy collector member. The apparatuses described herein may be configured so that they are annealed to have an oversized outer diameter compared to the vessel in which they are deployed, such as, for example, an inner diameter that is between 25% to 100% bigger in the annealed shape than the target vessel. For example the annealed shape may be between 1 mm and 2 cm (e.g., between 2 mm and 1.5 cm, between 2.5 mm and 1.25 cm, etc.). Any of the apparatuses described herein may have a large pore size. For example, the pore size may be between about 0.002″ and 0.05″ for (e.g., between 0.005″ and 0.05″, between about 0.0075″ and 0.05″, between about 0.01″ and 0.05″, between about 0.02″ and 0.05″, between about 0.03″ and 0.05″, between about 0.005″ and 0.04″, between about 0.005″ and 0.03″, etc.). In general, any of the methods and apparatuses described herein may include a biopsy collector that comprises a co-knit, co-weave, and/or co-braid of Nitinol and one or more fluffy polymer yarn. For example, the hybrid structure (co-knit, co-weave, or co-braid) may be a mix of a radial force creating element (such as a Nitinol wire, for example) and one or more tissue grabbing/storing element such as a polymer (e.g., polyester).
For example, a small-tube biopsy device may include: an inner member coaxially arranged within an outer member, so that the inner member may move axially in a distal and proximal direction relative to the outer member; a biopsy collector comprising a knitted or woven textile configured to collect biopsy tissue, wherein the biopsy collector is connected at a first end to the inner member and at a second end to the outer member and wherein a majority of the biopsy collector is retained within a lumen of the outer member in an un-deployed configuration; and a proximal handle coupled to the inner member and the outer member and configured to move the inner member distally relative to the outer member to drive the biopsy collector out of a distal end of the outer member so that it everts beyond the distal end of the outer member without rolling against it and expands radially into a deployed configuration.
In some variations the second end of the biopsy collector is not attached to the outer member. For example, a small-tube biopsy device may include: an inner member coaxially arranged within an outer member, so that the inner member may move axially in a distal and proximal direction relative to the outer member; a biopsy collector comprising a knitted or woven textile configured to collect biopsy tissue, wherein the biopsy collector is connected at a first end to the inner member and wherein a second end is biased to expand radially and invert and roll over itself (and in particular, invert over itself without rolling against a distal end of the outer member) as it is driven distally out of the outer member, further wherein the majority (e.g., 75% or more, 80% or more, 90% or more, etc.) of the knitted or woven textile is contained within the outer member in a pre-deployed configuration; and a proximal handle coupled to the inner member and the outer member and configured to move the inner member axially relative to the outer member to expand the biopsy collector.
As mentioned, any of the biopsy collectors may include a knitted or woven textile; in some variations the knitted or woven textile is attached to another material, such as metal or other material that may support the knitted or woven textile. For example, the knitted or woven textile may be attached as a sleeve, cover, layer, etc., connected to an additional expandable frame.
The knitted or woven textile may be generally formed of any appropriate material, including polymeric material, metals (e.g., shape memory materials), fibrous materials (natural or artificial fibrous materials, including cottons, collagens, etc.). The material may be configured, including by treatment, coating, impregnation, etc., with a material that enhances the ability of the knitted or woven textile to capture (and in some cases remove) biopsy material, such as cells and/or tissues.
In any of the apparatuses described herein, the apparatus is configured for use with a guidewire. Thus, the inner member and the biopsy collector may be formed to include a continuous longitudinal passage for a guidewire or guide catheter. Thus, any of these devices may include a guidewire lumen thought the inner member and the biopsy collector.
As mentioned above, in some variations, the biopsy collector is connected at the first end to a distal end (or end region) of the inner member. The biopsy collector may be connected at the second end to a distal end (or end region) of the inner member. The connection may be a rigid connection, in which the two parts are affixed together, or it may be a movable coupling, in which the biopsy connector is constrained for axial movement, but allowed to rotate (e.g., relative to the inner member when connected to the inner member or relative to the outer member for the connection to the outer member).
In general the proximal handle may be configured to move the inner member axially relative to the outer member to expand the biopsy collector so that the outer diameter of the biopsy collector is enlarged to contact the inner walls of a body lumen. For example, the handle may include a control (slider, knob, etc.) that drives the inner member movement relative to the outer member for deploying from the un-deployed configuration in which the biopsy collector (including the knitted or woven textile material) is held within the inner lumen of the outer member, including e.g., against the inner wall of the outer member. For example, the proximal handle may comprise a control configured to move the inner member axially distally and proximally relative to the outer member while holding the outer member in a fixed position. Any appropriate control may be used, including a mechanical, electrical or both (e.g., a slider, a knob, a lever, and a trigger).
In some variations, as mentioned above, the biopsy collector (e.g. the knitted or woven textile) may be attached to an inner surface of the outer member. The biopsy collector may be attached to an inner surface (e.g., the inner luminal surface) of the outer member in an inverted orientation compared to the attachment of the biopsy collector to the inner member.
Also described herein are methods of collecting biopsy material from within a body lumen using any of the devices described herein. For example, a method of collecting biopsy material (cells, tissue, etc.) from a wall of a body lumen may include: advancing a biopsy device distally towards the body lumen; moving an inner member of the biopsy device distally within an outer member of the biopsy device so that a knitted or woven textile that is attached to a distal region of the inner member and to a distal region of the outer member rolls out of a distal end of the outer member and expands against an inner wall of the body lumen; moving the knitted or woven textile relative to the inner wall of the body lumen to capture cellular material from the body lumen on the knitted or woven textile; and withdrawing the inner member of the biopsy device proximally so that the knitted or woven textile is drawn back into the lumen of the outer member.
The body lumen may be any appropriate lumen, such as, e.g., a fallopian tube, a urethra, etc.
In any of these methods, advancing the biopsy device may comprises passing the biopsy device over a guidewire positioned in the body lumen. Thus, the guidewire (or guide catheter) may be positioned first, and the biopsy device placed over the guidewire (or guide catheter).
In general, any of these methods may include inverting the biopsy collector (e.g., the knitted or woven textile) as it rolls out of the distal end of the outer member, typically after passing beyond the distal end opening of the outer member. As mentioned above, it may invert to form a torus-like structure (against the walls of the small-diameter body lumen). For example, the knitted or woven textile forms a torus as it rolls out of the distal end of the outer member.
The biopsy may be taken by moving the biopsy collector (e.g., the knitted or woven textile) relative to the inner wall of the body lumen, such as, but not limited to a fallopian tube. This may pull the exposed surface of the biopsy collector against the lumen wall(s), capturing biopsy material. In some variations, this may be accomplished by securing the inner member and the outer member together and drawing the biopsy device proximally. Alternatively or additionally, the biopsy collector may be rotated relative to the body lumen to move against the wall of the lumen and collect biopsy material; this may be accomplished in some variations by rotating the inner member and/or rotating the entire device. Thus moving the knitted or woven textile relative to the inner wall of the body lumen comprises one or more of: rotating the biopsy collector (e.g., at least the knitted or woven textile) relative to the inner wall of the body lumen, pulling the biopsy collector (e.g., knitted or woven textile) proximally relative to the inner wall of the body lumen, and/or pushing the biopsy collector (e.g., knitted or woven textile) distally relative to the inner wall of the body lumen.
Once the biopsy sample has been collected, e.g., onto the knitted or woven material of the biopsy collector, the biopsy collector maybe retracted back into the outer member by withdrawing the inner member proximally to roll the biopsy collector back into the lumen of the outer member. The outer member and retracted biopsy collector may then be withdrawn. Alternatively or additionally, the biopsy collector may be housed within a delivery catheter for removal from the body to prevent contamination. For example, in some variations the inner member may be retracted proximally to withdraw the biopsy collector into the outer member completely or partially, and the outer member and inner member, and the biopsy collector may be retracted into a protective sheath, catheter, etc. (e.g., a delivery catheter); this same protective sheath, catheter, etc. may be used for deploying the device into body.
Also described herein are variations of the small-tube biopsy devices in which the biopsy collector is a coil. For example, described herein are small-tube biopsy device comprising: an inner member coaxially arranged within an outer member, so that the inner member may move relative to the outer member; a biopsy collector configured to collect biopsy tissue and comprising a coil helically wound around the inner member, wherein the biopsy collector is connected at a first end to the inner member and at a second end to the outer member; and a proximal handle coupled to the inner member and the outer member and configured to rotate the inner member relative to the outer member to expand the biopsy collector.
In this example, the inner member may be rotated to open or close the helically wound spring forming at least part of the biopsy collector. The helically wound coil may be tightened (to form a smaller diameter) or loosened (to form a larger diameter). Thus, in some variations, both ends or end regions of the biopsy collector may be attached to the inner member (at a first end) and the outer member (at a second end).
As mentioned above, any of the apparatuses, including devices, described herein may include a liner (a sleeve, a layer, etc.) for collecting the biopsy material. For example, the methods described herein may include a liner or similar material coupling the coil and configured to collect biopsy tissue. In some variations the liner or sleeve is attached over the distal end of the biopsy collector. In some variations the liner is within the lumen formed by the biopsy collector coil. In some variations the line encloses all or a portion of the coil of the biopsy collector. As mentioned, the liner may be configured to capture and/or retain the biopsy material. For example, the liner may comprise a woven or knitted material.
Also described herein are methods of collecting biopsy material from within a body lumen using a device that includes an expandable coil For example, the methods may include: advancing a biopsy device distally into the body lumen; rotating an inner member of the biopsy device within an outer member of the biopsy device in a first direction so that a coil that is attached to a distal region of the inner member and attached to a distal region of the outer member expands against an inner wall of the body lumen, wherein the coil is helically wound around a distal portion of the inner member that is outside of outer member; moving the coil relative to the inner wall of the body lumen to capture cellular material from the body lumen; and rotating the inner member of the biopsy device in a second direction so that the coil is contracted.
As mentioned, moving the coil may comprise moving the coil so that a liner coupled to the coil moves against the inner wall and captures the cellular material.
In any of the methods of using a device having a coil described herein, the method may include withdrawing the coil proximally into a lumen of a second outer member to protect the collected tissue.
Advancing the biopsy device may comprise passing the biopsy device over a guidewire positioned in the body lumen.
Also described herein are apparatuses and methods of using them that are configured to be screwed into the lumen to take a biopsy. For example, described herein are apparatuses such as small-tube biopsy devices comprising: an inner member coaxially arranged within an outer member, so that the inner member may move relative to the outer member; a helical biopsy collector configured to collect biopsy tissue and comprising a coil helically wound around the inner member, wherein the biopsy collector is connected to the inner member; and a proximal handle coupled to the inner member and the outer member and configured to rotate the inner member relative to the outer member.
As mentioned, any of these devices may include a liner coupled with the coil and configured to collect biopsy tissue. The liner may be formed of a woven or knitted material.
A method of collecting biopsy material from within a body lumen using such a device may include, for example: advancing a biopsy device distally towards the body lumen; rotating and distally advancing an inner member of the biopsy device relative to an outer member of the biopsy device so that a coil that is attached to the inner member screws against an inner wall of the body lumen and advances within the body lumen, wherein the coil is helically wound around a distal portion of the inner member that is outside of outer member; capturing cellular material from the body lumen as the coil is rotated and distally advanced; and withdrawing the inner member proximally. Capturing the cellular material may comprises capturing the cellular material in a liner coupled to the coil.
Withdrawing the coil proximally may comprise withdrawing the inner member proximally into a lumen of a second outer member to protect the collected tissue. Advancing the biopsy device may comprises passing the biopsy device over a guidewire positioned in the body lumen.
For example, described herein are methods of collecting biopsy material (e.g., from within a body lumen, such as from within a fallopian tube), which may include: advancing a biopsy device distally towards an opening into the body lumen (e.g., fallopian tube); extending a tube of braided textile distally into the fallopian tube by moving an inner member of the biopsy device distally within an outer member of the biopsy device, wherein a first end region of the braided textile is attached to a distal region of the inner member and a second end region of the braided textile is attached to a distal region of the outer member, so that the tube of braided textile extends distally from a distal end of the outer member and everts over itself as it extends into the fallopian tube; capturing cellular material from the fallopian tube on pores within the braided textile; and withdrawing the inner member of the biopsy device proximally so that the tube of braided textile is inverted and drawn proximally back into the lumen of the outer member. Capturing the cellular material may include moving the tube of braided textile against an inner wall of the fallopian tube to capture the cellular material.
Advancing may include advancing the biopsy device with the tube of braided textile completely within the outer member.
Capturing cellular material from the body lumen may include applying compressive force on the braided textile to form a stable column of braided material in an un-inverted configuration within the outer member. The braided textile (e.g., tube of braided textile) may be configured to provide column strength to prevent buckling or bending, e.g., by having (e.g., when there are between 40-50 strands/threads forming the braided textile) a braid angle of 25 degrees or less on the braided textile in the un-deployed configuration within the outer member. The outer diameter of the braided tube in the un-deployed configuration (under compression) may also be greater than 90% the inner diameter of the outer member.
The tube of braided textile may form a distally-extending torus as it extends out of the distal end of the outer member. In some variations, capturing comprises holding the outer member relative fixed and advancing the inner member distally to extend the tube of braided textile distally into the fallopian tube. Capturing may also include moving the tube of braided textile by: rotating the tube of braided textile relative to the fallopian tube, pulling the tube of braided textile proximally relative to the fallopian tube, and/or pushing the braided textile distally relative to the fallopian tube.
Although the methods and apparatuses (including systems and devices) described herein are directed in particular for biopsying the fallopian tubes, any of these devices and methods may be adapted for sampling other region, and particular tubular, body regions, such as the mouth, nasal passages, ear canals, esophagus, brachial passages, rectum, small intestine, etc.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
FIGS. lA and 1B show an example of a biopsy apparatus (e.g., a small-tube biopsy device) as described herein.
Described herein are method and apparatuses (e.g., devices and systems) for taking a biopsy from the inside of a small tube without rupturing or dissecting the small tube. The methods and apparatuses described herein may be used for any body lumen, including in particular small-diameter body lumen, such as the fallopian tubes, urethra, etc.
In general, these devices may include a first end of a biopsy collector (e.g., biopsy collection member) connected at a first end (e.g., a distal end) to an inner member. The biopsy collector may be expandable, so that it may expand against the walls of the body lumen from which the biopsy is being taken. The second end (e.g., a proximal end) of the biopsy collector may be coupled to an outer member. This coupling may be rigid (e.g., fixed attachment) or movable (e.g., sliding, rotating, etc.). The inner member may be slideable within the outer member. The inner and outer members may be catheters, or other flexible, tubular members. In some variations the inner or outer members may be coils. The outer member may be coaxially arranged around the inner member. The device may be deployed by relative motion between the inner member and the outer member that allows the biopsy collector to expand to contact the walls of the lumen (e.g., of the urethra, fallopian tubes, etc.). For example, in some variations the inner member may be moved distally to allow the biopsy collector to expand out and in to the narrow tube (e.g., fallopian tube) to contact the walls and take a sample of the tissue; reversing the motion, the biopsy collector may be collapsed back down and in some variations drawn into the outer member, which may be a catheter. Any of these devices may also include a second outer member (e.g., outer catheter, such as a delivery catheter) that may house the inner and/or outer catheter to prevent loss or contamination of the biopsy material when inserting or removing the device.
In some variations the apparatuses described herein include an everting knitted or woven member for capturing tissue material, e.g., biopsy material, that forms all or a part of the biopsy collector portion of the device. The everting knitted or woven material may generally be adapted for use as a biopsy collection material. For example the everting knitted or woven material may include a column strength that is sufficient so that pushing on the material distally by pushing on the inner member drives the material out of the distal end of the outer material, allowing it to invert and expand against the inner lumen of the body vessel.
The biopsy collector material may be woven or knitted, as described herein, and may also be configured to remove material (biopsy material) from the lumen wall without puncturing or otherwise rupturing the lumen wall, but may also be configured to retain all or the majority of the tissue removed.
A small-tube biopsy device as described herein may have a biopsy collector that everts to sample the inner wall surface of a body vessel. The everting biopsy collector may therefore gently roll out into a small vessel or conduit to form a torus shape in which the outer walls of the torus are driven against the wall(s) of the vessel. When the biopsy collector is retracted back into the device, e.g., by inverting back into the device, the biopsy tissue captured by the biopsy collector may be protected.
In general, the rolling and everting motion of the biopsy collector may reduce or eliminate deployment shear force to the vessel/conduit wall. The variations described herein may therefore avoid hydraulic forces.
For example,
A biopsy collector 107 is attached at either of its ends to the inner member and the outer member in the example shown in
In
Having the biopsy collector retracted into the outer catheter as shown may protect the biopsy collector to prevent contamination as the device is positioned (e.g., over a guidewire) within the body. This configuration also forms a passage or channel for a guidewire. In some variations a separate guidewire lumen may be included within the inner member and/or the biopsy collector, e.g., by a sleeve or internal catheter, to prevent or limit contact between the biopsy collector and the guidewire. The device may also include a proximal handle (not shown in
Thus, in use, no hydraulic forces are used, only everting column force. The biopsy collector may be any appropriate material. For example, in some variations the biopsy collector includes a laser slotted material, a textile (e.g., a braid, knit, or woven) material formed of filaments, or the like.
In general the biopsy collector may be configured so that, when pushed distally 155 by the inner member, it has sufficient column strength so that it can push the textile material out of the distal end of the outer member, as shown in
The column strength may be set by the structure of the biopsy collector. For example,
As mentioned, in any of the biopsy collectors described herein the biopsy collector may be formed by a combination of materials, including metallic materials (e.g., shape memory alloys, such as Nitinol, Steel, Elgiloy, MP35n, etc.) that may be filaments or wires, and one or more polymeric filaments or natural filaments. These filaments may be monofilaments or groups of filaments. In some variations the ratio of metallic filaments to non-metallic filaments (e.g., polymeric filaments) may be 1:1 or may have more non-metallic filaments, such as 1:2, 1:3, 1:4, 1:5, etc. Ins some variations there may be more metallic than non-metallic filaments, e.g., the ratio of metallic filaments to non-metallic filaments may be, e.g., 2:1, 3:1, 4:1, 5:1, 6:1, etc.
The non-metallic filaments may help in capture and retaining the biopsy material; in some variations the metallic filaments may help in removing the biopsy material when pulled against the wall of the vessel.
As mentioned above, once the biopsy collector is deployed, a pulling shear force may be applied to the structure to gently scrape the vessel/conduit wall to take a tissue sample/cells from the inner wall. This is described in
In this example a guidewire 223 may be first directed in to the vessel to or past the region to be biopsied 221. The small-tube biopsy device may then be sent over the guidewire in the un-deployed configuration, as shown in
Thus, the method of using the device may include moving the inner member of the biopsy device distally within the outer member of the biopsy device so that the biopsy collector (e.g., the knitted or woven textile forming at least part of the biopsy collector) is everted 213 as a torus along the inner surface of the vessel 219. The biopsy collector remains attached to a distal region of the inner member 203 and to a distal region of the outer member 207 so that movement of the inner member causes the biopsy collector to roll out of a distal end of the outer member and expand against an inner wall of the body lumen, as shown in
In some variations, the biopsy collector may then be moved (e.g., moving the knitted or woven textile) relative to the inner wall of the body lumen to capture cellular material from the body lumen on the knitted or woven textile. This movement may include scraping the biopsy collector against the lumen wall, e.g., by rotating, pulling or pushing the biopsy collector relative to the wall, or it may simply include allowing the biopsy collector to roll against the lumen wall when deploying the biopsy collector, as shown in
In
The entire device may then be moved 443 relative to the vessel, as shown in
As illustrated schematically in
As mentioned above the biopsy collector may have a porosity that is configured to help with retention of biopsy material. For example the apparatus may have pores of bigger or smaller gaps; bigger gaps may be formed from using fewer filaments (e.g., less wires per unit circumference), which may also increase roughness. The material used to form all or a portion of the biopsy collector may be metallic, polymeric (e.g., smooth and/or hairy elements), natural fibers, etc.
The biopsy collector may also be configured to adjust the radial force or contact force with the lumen of the vessel. For example, a greater radial force may increase the shear. The filament diameter (e.g., wire diameter), the filament material (e.g., metallic, polymeric, natural, etc.), and/or the number of filaments forming the biopsy collector may all contribute to the radial force as well as the ability to capture biopsy material. In general, the mechanical leverage provided by the biopsy collector may be related, at least in part, to the radial force that can be increased by the proximal handle, which may create an increased radial force by using the inner and outer members (e.g., inner and outer catheters). Any of the biopsy collectors described herein may also be formed of multiple layers. For example, a rougher outer layer (e.g., a rougher woven/knitted outer portion of the biopsy collector) may be adjacent to a more tissue-retaining layer that may be ‘softer’. For example, a woven or knitted material that is formed of a natural fiber or other material configured to retain tissue.
The length of the biopsy collector may also be adjusted. For example, the length of the biopsy collector may be adjusted to adjust the applied force per unit length applied to the vessel. Shorter lengths (e.g., lengths of between 0.2 cm to 50 cm, e.g., between 0.2 cm to 30 cm, between about 0.2 cm to 25 cm, between about 0.2 cm to 20 cm, between about 0.2 cm to about 15 cm, between about 0.2 cm to 10 cm, etc.) may be used.
In general, the biopsy collector (which may alternatively be referred to herein as an everting biopsy collector) may also be pre-shaped or biased to a particular form, such as a self-expanding configuration, as mentioned above. For example, the biopsy collector may be annealed into an expanded configuration. In any of these variations, the distal member may be pre-shaped (e.g., annealed) and/or reinforced to deploy the biopsy collector to a set predefined length, so that the distal end and proximal end are pre-shaped into a deployed configuration when extended distally, as shown in
In some variations the devices described herein may include a biopsy collector that includes a laser-slotted tube, such as a tube having a 0.002″ thick wall (or a wall thickness of less than about 0.0002 to 0.0004″). The tube may be formed of a shape memory material, such as Nitinol (e.g., having a 1 mm OD). In some variations the biopsy collector comprises a textile that is braided and has between 24-72 ends (e.g., strands), having a 1 mm OD, and a low braid angle. The strands may be between about 0.00025″ to 0.002″ diameter, and may be round or flat wires, such as Nitinol, Platinum Iridium (which are radiopaque). In some variations the biopsy collector comprises a polymer metal hybrid that may include Nitinol mixed with PET multifilament (e.g., 0.001″ Nitinol with 100 Denier PET multifilament highly textures), e.g., braided to a 10 mm diameter in the jammed state (e.g., compressed within the outer member).
In any of these variations, twisting or rotating the inner and outer members relative to the everting member may create a cork screw like surface on everting member, increase tissue scraping effect.
In some variations the biopsy collector may be a knit material. The knit may be a circular or warp knit, for example, formed from 0.001″ Nitinol wires that are mixed with 100 denier PET multi filaments (which may result in a highly textured knit).
For example, a biopsy collector may be configured to expand when it is everted, as described above, which may help contact the wall(s) of the vessel lumen. In some variations the biopsy collector may be configured to expand uniformly, e.g., to a uniform expanded diameter. Alternatively, the biopsy collector may be configured to expand to a shape, such as a tapered shape. In general the expanded biopsy collector may be configured to roll over the inner lumen of the vessel even where the vessel wall is uneven.
In any of the biopsy collectors described herein the surface texture may be adjustable from smooth to rough. For example, the biopsy collector may be formed of fine, tight filaments, which may provide a smoother, less abrasive surface, or may be formed of larger, less round or flat filaments (flat wires, multifilament yarns) which may provide a rougher, more abrasive surface. As mentioned, the biopsy collectors described herein may also be configured to adjust the porosity. For example, biopsy collectors having fewer filaments may have an increased roughness, but higher porosity.
In any of the biopsy collectors described herein, the contact force of the biopsy collector as it expands into the vessel may be adjustable (and in particularly, non-hydraulically adjustable). The contact force of the biopsy collector may adjustable to the vessel/conduit inner diameter (ID). This contact force may be adjusted by selecting the filament size, filament material type, and/or by adjusting the relative positions of the inner member to the outer member position. As described above in
Any of the variations described herein may be configured to allow visualization during use, including with fluoroscopy or other techniques. For example, the material used for any part of the devices described herein, including the biopsy collector, inner member, outer member, etc. may be formed of or marked with a material, e.g., polymer, metal, type of metal and size of metal, etc., including mixes of radiopaque materials and other materials. For example, the biopsy collector may include a radiopaque material and a tissue grapping material (e.g., a combination with a polymer such as PET).
The biopsy sample may then be recovered as illustrated in
Once removed from the body, the biopsy sample may be tested in any appropriate manner. For example,
As mentioned above, any of the apparatuses described herein may include proximal handle that may coordinate the operation of the device. For example,
Another example of a small-tube biopsy device in which the biopsy collector is configured as a helically wound coil is shown in
Another alternative variation is shown in
In the variations shown in
As mentioned above, the biopsy apparatuses described herein may be used with any appropriate body lumen, including a fallopian tube. This is illustrated in
In general, the fallopian tube may have an inner diameter that is less than about 1 cm, thus the apparatuses described herein may be configured so that the biopsy collector portion is annealed to have an outer (everted) diameter that is slightly larger than the inner dimeter (may be between 0.5 cm and 1.5 cm, between 0.7 cm and 1.2 cm, etc.). In some cases the inner lumen of the fallopian tube may have a somewhat irregular (e.g., non-smooth) surface in cross-section. The biopsy collectors described herein, and particularly those formed of a textile material (e.g., braided, woven and/or knitted) may be sufficiently compliant to allow expansion when everting and apply radially outward force against this irregular surface without shearing the inner lumen during deployment. In some cases the tubular body (including but not limited to the fallopian tube) into which the device is to be deployed may be configured so that it expands and opens the tubular body as it is deployed. As described in greater detail below, the apparatuses described herein may therefore be configured to open, and in some cases clear out, a vessel instead or in addition to biopsying the vessel.
Any of the devices, and particularly the biopsy collector portion of the device may be configured to provide a radial force when deploying that is sufficient to open and/or expand a tubular structure, such as fallopian tube. The radial force may be determined or adjusted by, for example, the stiffness of the filaments (e.g., wire and/or polymer or natural filaments) used to form the biopsy collector portion. Thus the hoop stiffness of the biopsy collector may be sufficient to hold open the vessel and/or to apply adequate radial force against the wall of the vessel so that a biopsy can be taken even when the wall has an irregular cross-section.
Once collected, the sample may be stored and/or analyzed. For example, the biopsy collector region may be everted back out of the device and into a sample storage device, e.g., containing a buffer or other storage medium. In some variations the entire distal end of the device may be stored for later removal of the biopsy material from the biopsy collector region. Alternatively in some variations the biopsy collection region may be disengaged from all or a portion of the device and stored in a storage medium for later processing. For example, the distal end of the outer member and/or all or a portion of the inner member may be cut or otherwise removed from the rest of the apparatus and stored in buffer/storage medium. In some variations the device may include a detachment or frangible portion to allow detachment and separation of the distal end region including the biopsy collector portion to be removed for storage and later for removal of the biopsy material. In some variations the biopsy collector portion may be pushed out and cut off of the inner and/or outer members for insertion into a storage medium (e.g., within a tube) for later processing.
In some variations, the liner or sleeve may be configured as a fabric liner. For example, a fabric liner may be a knitted material formed by knitting an 80 denier polyester, using a 22 needle machine. The liner outer diameter (OD) may be less than about 1 mm, constrained. An example of a braided liner may be formed of an 80 PET material having 48 ends (e.g., 48 filaments, which may be monofilaments or poly-filaments) that have the same dimensions as described above. For example, the ranges of dimensions may be, e.g., for knitted variations, between about 20-150 Denier, 12 needle to 40 needle (less needles for larger Denier yarns). For braided variations, between about 20-150 Denier, 24 to 72 ends (more ends less yarns). In some variations, including an ePTFE thin walled tube, the tube may have an outer diameter of about 2 mm, 0.001″ or thinner wall thickness. As mentioned above, the liner may be internal to the outer everting member (e.g., an inside liner) or external to the everting member (e.g., as a skin or covering). The inside liner may be useful for to trapping and/or containing biopsy tissue or cells that may move through the outer everting material. When the liner is outside of the biopsy collector element, it way function as a rough, highly porous cell capturing skin.
In general, the apparatuses described herein may be configured so that the biopsy collector, which may be woven or braided from a plurality of filaments, assumes a jammed configuration when un-inverted (including when within the outer cannula), in which the biopsy collector is prevented from collapsing beyond a minimum inner diameter in the un-deployed (and un-inverted) configuration. For example, a small-tube biopsy device may include: an inner cannula coaxially arranged within an outer cannula, so that the inner cannula may move axially in a distal and proximal direction relative to the outer cannula; a biopsy collector comprising a woven or braided mesh formed of a plurality of filaments, wherein the biopsy collector is porous and is connected at a first end to the inner cannula and at a second end to the outer cannula, further wherein the biopsy collector has a first, un-deployed, configured in which a majority of the biopsy collector is un-inverted (and in some variations may be at last partially retained within a lumen of the outer cannula), and a second, deployed, configuration in which the majority of the biopsy collector is inverted relative to the un-deployed configuration, and may be expanded beyond an outer diameter of the outer cannula; and a proximal handle coupled to the inner cannula and the outer cannula and configured to move the inner cannula axially relative to the outer cannula to transition biopsy collector between the first un-deployed configuration and the second deployed configuration, wherein the biopsy collector is configured so that the number and/or size (e.g., cross-sectional dimensions and/or shape) of the plurality of filaments maintains an inner diameter of the biopsy collector in the first, un-deployed configuration at greater than 40% (e.g., 50% or more, 55% or more, 60% or more, 70% or more, 75% or more, 80% or more, 85% or more, 90% or more, etc.) of an inner diameter of the outer catheter. Alternatively or additionally, the biopsy collector may be configured so that the number and/or size (e.g., cross-sectional dimensions and/or shape) of the plurality of filaments (e.g., wires) cause the biopsy collector to jam at a minimum diameter that is greater than or approximately the same (e.g., 80% or more, 85% or more, -90% or more 95% or more, 100% or more, etc.) of the inner diameter of the inner cannula when un-inverted.
Thus, any of these apparatuses described herein may include a biopsy collector that is porous and/or radio-opaque and/or configured to have a jammed configuration in the un-deployed configuration, when not-inverted, that maintains the radial patency of an inner lumen formed by the braided or woven biopsy collector that is continuous with an inner lumen of the inner cannula.
Although the biopsy collector may be biased to jam to a minimum inner diameter in the un-inverted configuration by heat setting the braided or woven filaments forming the biopsy collector, in some variations it may be particularly beneficial to configure the biopsy collector so that jamming is based on the number and/or size (e.g., cross-sectional dimensions and/or shape) and/or the arrangement (e.g., braid angle) of the plurality of filaments. For example, in some variations, particularly those configured to work with an outer member having a diameter of between 1 mm and 15 mm (e.g., between about 1 mm and about 12.5 mm, between about 1 mm and about 10 mm, between about 1 mm and 8 mm, between about 1 mm and 6 mm, etc.), the filaments may be, e.g., about 0.00025″ and about 0.05″ wires (e.g., between about 0.0005 to about 0.01″, between about 0.0005″ to about 0.005″, etc.), and the plurality of filaments may include 24 or more strands (e.g., 36 or more, 48 or more, 60 or more, 72 or more, 84 or more, etc.). At these combinations of filament number, filament size, and/or braid angle, the biopsy collector maybe prevented from collapsing to an inner diameter that is narrower than the jammed diameter (e.g., approximately 90% or more the inner diameter of the inner cannula to which the biopsy collector is attached). Thus, the jamming may be mechanically achieved, rather than relying on shape setting, which may otherwise be more prone to failure.
This minimum jammed diameter (minimum inner diameter) may provide a reliable lumen or channel that is continuous with the lumen of the inner cannula, which may ensure that a device, such as a guidewire, camera, biopsy tool, etc. may be passed through the device.
For example,
As shown in
The biopsy collector may be braided or woven at any appropriate filament (e.g., braid) angle. The filament angle may help set the minimum jamming diameter. In general, these biopsy collectors may be deployed without requiring or implicating hydraulic pressure; they are not typically hermetically sealed, but instead are porous and/or permeable. The outward radial force of the biopsy collector may be controlled by the material stiffness of the filament material, e.g., stainless steel, Nitinol, etc. As mentioned, the material dimensions (e.g., the diameter and/or shape, such as round cross-section, square cross-section, rectangular cross-section, etc.), and/or the number of wires. In particular, the number of wires may be determinative.
The biopsy collector typically forms an everting tube that everts (inverts) over onto itself. The everted tube column force may be defined, at least in part, by the outward radial force and textile filament (e.g., braid) angle. For example, the higher braid angle may create an outer tube jammed column having a higher column force with a relatively low bending stiffness.
Any of the apparatuses described herein may include a biopsy collector that does not expand substantially (e.g., similar to that shown in
The methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
In any of the devices described herein, the biopsy collector may include a braided textile having a braid angle in the un-deployed configuration of 25 degrees or greater, and an outer diameter 85% or greater of the inner diameter of the outer member (e.g., 90% or greater, between about 0.9 and 0.999 times the inner diameter of the outer member) in the un-deployed configuration. This is illustrated in
In use, this apparatus may be used to take a biopsy from within a body lumen; the user (e.g., doctor) may grasp the handle and/or secure the outer member while advancing the inner member distally to extend the tube of braided material distally out of the end of the outer member and into the lumen (the outer member may remain outside of the lumen or may stay fixed relative to the lumen), as described above.
Biopsy devices 1700 in which the braid angle of the tube of braided textile has a small braid angle may prevent locking up (e.g., “cleating”) of the tube of material within the lumen of the outer member during operation of the device. This is illustrated in
Any of the apparatuses described herein may alternatively or additionally control the braid angle of the inverted biopsy collector, e.g., in a knitted, braided or woven device. For example, a braided textile forming the biopsy collector may be configured to have a high braid angle of, e.g., 125 degrees or more in the everted configuration that is extending distally from the outer member. This braid angle may be a post-annealed (e.g., shape-set) angle.
For example,
In any of the apparatuses (e.g., devices, systems, etc.) described herein, the apparatus may have a biopsy collector that is between about 5 mm and 40 mm long (e.g., between about 5 and 30 mm long, between about 10-30 mm long, etc.). In addition, the apparatus may be configured so that only about half of the biopsy collector is extended from the distal end of the outer member (e.g., catheter), providing an effective biopsy collector length of between about 2.5-20 mm long (e.g., between about 5-20 mm long, between about 7-15 mm long, etc.). Other lengths may be used.
For example, some variations of these apparatuses may be configured as fallopian biopsy devices. Such devices may have, for example, an outer diameter of the outer member (of between about 1 mm and about 1.5 mm (e.g., between about 1.1-1.3 mm, between about 1.2-1.4 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, etc.). The outer diameter of the inner member may be, for example, between about 0.5 mm and about 0.9 mm (e.g., between about 0.5 and about 0.75 mm, between about 0.6 and about 0.8 mm, etc.). The inner and outer members may be any appropriate length and flexibly to allow the biopsy device to be delivered to the desired body lumen. For example, the length of the outer member may be between 10 cm and 1 meter. The inner member may be longer than the outer member. The outer member may be a cannula. The inner member may be a rod, wire, cannula, hypotube, etc. The handle may limit the extension (e.g., fully extended length) of the biopsy collector to the desired length (e.g., 5 cm or less, 7.5 cm, 10 cm, 12 cm or less, etc.)
As mentioned above, the biopsy collector may be formed as a textile of knitted, woven or braided material. The material forming the textile may be a polymeric material and/or a metallic material (e.g. Nitinol). In some examples, the biopsy collector is a braided material formed by between 20-60 strands of braided wire, such as 0.002 inch wire (e.g., between about 0.0015 inch wire and 0.0025 inch diameter wire). In some variations the biopsy collector has an outer diameter of 0.025 inches (approximately 0.63 mm in the inner diameter). For example, the apparatus may include a braided tube forming a biopsy collector having between about 24 and 48 strands. Lower strand numbers may provide a higher porosity (e.g., larger sized pores or openings).
Any of the apparatuses described herein may be adapted to biopsy other regions of the body, including, for example, the uterus (e.g., endometrial biopsy), urethra, nose, sinus cavity, GI tract (e.g., colon, rectum, small intestine, etc.), esophagus, ear, etc. Thus, any of the devices described herein may be scaled to biopsy from these regions. Scaling may be linear in size; in variations in which the biopsy collector is formed of multiple knitted, woven or braided strands, the number of strands may be increased or decreased accordingly (as the device is scaled). One exemplary device may include a biopsy collector having between 65-80 (e.g., about 72) strands of 0.004″ Nitinol, having an everted outer diameter of about 15 mm, and an everted braid angle of greater than 125 degrees. This device may be used for uterine biopsy (e.g., endometrial biopsy). Another example may have a biopsy collector having between 135-155 (e.g., about 144) strands of 0.004″ Nitinol, having an everted outer diameter of about 22 mm, and an everted braid angle of greater than 125 degrees. The inner member may be a 5F (e.g., 0.065″ OD inner catheter or rod) and the outer member may be a catheter having a 7F (e.g., 0.091″ OD).
In general the strands forming the biopsy collector may be any shape (cross-sectional shape), including round, oval, square, triangular, etc. as mentioned. These wires may be radiopaque to aid in visualization (e.g., under fluoroscopy, ultrasound, etc.) or may include other markers.
Any of these methods may be used in conjunction with a dye, contrast, or the like. For example, a dye may be delivered through the inner member. As mentioned above, any of these device may also or alternatively be used to help open a collapsed tube or lumen.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application claims priority to U.S. Provisional Patent Application No. 62/832,784, filed on Apr. 11, 2019, titled “SMALL TUBE TISSUE BIOPSY,” and U.S. Provisional Patent Application No. 62/929,761, filed on Nov. 1, 2019, titled “SMALL TUBE TISSUE BIOPSY.” Each of these application is herein incorporated by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
62832784 | Apr 2019 | US | |
62929761 | Nov 2019 | US |