Sample collection device

Abstract

A specimen retrieval device is disclosed that utilizes a constrictive mesh to aid in specimen containment and retrieval during minimally invasive surgical procedures. The device facilitates specimen isolation and removal and allows specimen removal through a smaller incision than conventional extraction bags by constricting and stretching the specimen with tension provided by pulling on the specimen retrieval device to actuate the internal woven fibers. A two-hole opening allows for optimal specimen orientation. In certain aspects, the device is configured to distribute the pulling tension over a larger area, thereby reducing the likelihood of specimen tearing during removal. Large specimens are safely collapsed to a size and shape that allows for easy removal. TIFF2023542790000002.tif92157

Description

Technical Field

[0001] Paragraph Regarding Priority This application claims priority to U.S. Provisional Patent Application No. 63 / 057,511, filed July 28, 2020, and U.S. Provisional Patent Application No. 63 / 189,388, filed May 17, 2021; each of these provisional applications is hereby incorporated by reference in its entirety.

[0002] Description of Research Funded by the Federal Government Not Applicable

Background Art

[0003] Background The field of minimally invasive surgery has become common. Large specimens are being removed using minimally invasive techniques. The port size limits the removal of these larger specimens. Current methods for removing specimens involve placing them in a laparoscopic specimen retrieval bag and pulling it out of the body cavity. This extraction method causes the specimen to bunch up at the bottom of the bag. Additional force or a larger hole is required to complete the extraction. There is a need for an additional device for removing specimens from the body cavity.

Summary of the Invention

[0004] Summary Certain embodiments relate to a specimen retrieval device. This specimen retrieval device converges relative to its minor axis when the device or a portion of the device is stretched. This convergence reduces the specimen profile, enabling efficient specimen retrieval. The specimen retrieval device allows for the retrieval of surgical specimens through smaller incisions than current standard care. The device may have one or two openings to allow for optimal orientation of the specimen. The device may contain an internal woven mesh structure or braid, such as a sleeve. The mesh or braid structure provides two configurations: an expanded configuration and a constricted configuration. The device may have a directionally resistant, high-friction wall that can reduce specimen slippage during retrieval. The specimen may be moved into the sleeve while the wall obstructs its movement in the opposite direction, out of the sleeve's inlet port. The device may include an impermeable wall or layer and a cinching mechanism that can create a waterproof encapsulation device. In certain embodiments, a sleeve is provided having two openings that can be closed to contain a specimen. In other embodiments, the sleeve may have a bag-like configuration with a single opening that can be closed to contain the specimen. Various embodiments maintain the ability to control the specimen's shape by manipulating the woven mesh structure and facilitating the removal of the specimen from the body cavity.

[0005] The sample collection device may include a proximal opening and a distal opening (or alternatively, a distal opening), a flexible, elongated body or sleeve extending from the proximal opening to the distal opening, a stencilable, tubular woven mesh or braided structure extending from the proximal opening to the distal opening, and optionally, a plurality of surface protrusions (surface protrusions located on the inner surface of the sleeve).

[0006] The proximal opening may be configured to be positioned proximal and external to the opening in the body wall of the subject. In some aspects, the proximal opening may be a foldable ring or a section of foldable material to form a loop. It may be configured to receive other instruments such as a handle. The foldable ring may have a hinge or similar device and / or mechanism that allows the ring to be folded or unfolded, or otherwise closed. In some aspects, the foldable proximal ring may be able to fold or unfold on or along an axis perpendicular to the long axis of the device. In some aspects, the proximal opening ring may have a handle attached thereto. The proximal opening ring may be able to securely fix the device outside the body wall and may be configured for this purpose. The proximal opening also provides a pull point for narrowing the sleeve diameter, for removing a specimen positioned within the device, and / or for removing the device. In certain situations, the pull point is independent of the handle, allowing the device's sleeve or body (containing a securely fixed specimen) to be removed while the handle portion remains in place. The specimen handling portion may be located in a removable position within an access body or tube outside the specimen removal device. In certain situations, a ring may be formed by folding the mesh to create a ring or loop with a lumen into which a handle or other device can be inserted. The ring may be formed by folding the end portion of the sleeve over itself. In certain situations, the entire specimen removal device may be introduced into a body cavity, and therefore, in certain embodiments, the external portion is optional.

[0007] The distal opening may be at the end of the device opposite the proximal opening, or at the closed end of the sleeve. In some aspects, the distal opening, proximal opening, or distal and proximal openings may be flexible or inflatable rings that can change the diameter (particularly the inner diameter) or be closed (e.g., by scinting the opening to minimize the inner diameter of the opening). The device may include mechanisms such as locks or scints, or inflatable rings, that can change the inner diameter of the distal opening, proximal opening, or distal and proximal openings. During withdrawal, the diameter of the distal opening, proximal opening, or distal and proximal openings may be reduced, and the distal opening, proximal opening, or distal and proximal openings may be closed to contain essentially all or all of the contents of the specimen. In some aspects, the lock may be a cinchlock, drawstring, snap, clip, hook and loop (e.g., VELCRO®), zipper, zip lock, slide lock, or lock with interlocking edges (e.g., male / female compliment). In some aspects, the distal opening, proximal opening, or rings of both distal and proximal openings form a watertight seal within the body cavity of the subject before the specimen is removed. The seal may be designed to contain, or substantially contain, any bodily fluids or debris that may be discharged from the specimen as it is manipulated, converged, and / or squeezed out of the body. In some aspects, the lock can facilitate the formation of a watertight seal. The proximal and distal openings may allow for optimal orientation of the specimen. In certain aspects, the distal opening may be closed before, during, or after placement to form a bag structure. If pre-placement, the sleeve is effectively a bag with the same convergence characteristics as a sleeve configuration.

[0008] A flexible, elongated body or sleeve may form a channel along the long axis of the device configured to cross an opening in the body wall of the subject, and may be configured to provide an access channel through which a specimen removal instrument can be introduced into the body cavity. The flexible, elongated body or sleeve, or at least a portion thereof, may be transparent. The flexible, elongated body or sleeve, or at least a portion thereof, may be made of a first material, which includes a flexible, foldable, and impermeable material, such as an impermeable plastic. The first material may be impermeable to body fluids and cells to prevent spillage during specimen removal. In some aspects, the first material is an impermeable, biocompatible, and transparent plastic.

[0009] In some aspects, the elongated body or sleeve may be incorporated into a tubular woven mesh or braided structure, and the mesh or braided structure and the elongated body may form a single layer; or the elongated body or sleeve may surround or be surrounded by the mesh or braided structure (similarly, the mesh or braided structure may surround or be surrounded by the elongated body or sleeve), and the elongated body or sleeve and the mesh or braided structure may form separate layers. In some aspects, the elongated body or sleeve may be incorporated into the mesh or braided structure by coating and / or adding a first material, such as an impermeable material, into or on the mesh or braided structure.

[0010] A retractable, tubular woven mesh or braided structure may have two configurations: an expanded configuration and a narrowed configuration. The tubular mesh or braided structure may have a larger cross-sectional diameter in the expanded configuration compared to the cross-sectional diameter in the narrowed configuration, with respect to the cross-sectional diameter along a transverse plane perpendicular to the long axis of the device. For use herein, the cross-sectional diameter of the device, the cross-sectional diameter of the elongated body or sleeve, and the cross-sectional diameter of the channel formed by the elongated body and the tubular mesh or braid refer to the cross-sectional diameter of each part along a transverse plane perpendicular to the long axis of the body. The expanded and narrowed configurations may be interchangeable by changing the length of the device and the mesh or braid, where the mesh or braid may change from an expanded configuration to a narrowed configuration by lengthening the device and the mesh or braid, and the mesh or braid may change from a narrowed configuration to an expanded configuration by shortening the device and the mesh or braid. In some aspects, the tubular mesh or braid in the extended configuration may have a length of 0.01 to 5000 cm or at least one, equal to one, or between two of the following: 0.01, 0.05, 0.1, 1, 5, 10, 50, 100, 500, 1000, 2000, 3000, 4000, and 5000 cm; and an average cross-sectional diameter of 0.01 to 1500 cm or at least one, equal to one, or between two of the following: 0.01, 0.05, 0.1, 1, 5, 10, 50, 100, 500, 1000, and 1500 cm.In some aspects, the tubular mesh or braid in the narrowed configuration may have a length of 0.07 to 7000 cm or at least one, equal to one, or between two of the following: 0.07, 0.1, 1, 5, 10, 50, 100, 500, 1000, 2000, 3000, 4000, 5000, 6000, and 7000 cm; and an average cross-sectional diameter of 0.005 to 1200 cm or at least one, equal to one, or between two of the following: 0.005, 0.01, 0.05, 0.1, 1, 5, 10, 50, 100, 500, 800, 1000, and 1200 cm. Generally, the diameter and length of the expanded / constricted sleeve are slightly larger than the dimensions of the specimen to be encapsulated and removed from the body when the sleeve is designed. The length and cross-sectional diameter of the channel formed by the elongated body may depend on the length and cross-sectional diameter of the tubular mesh or braid, and vice versa. For example, the cross-sectional diameter of the channel may be reduced by reducing the cross-sectional diameter of the tubular mesh or braid, which may be done by lengthening the tubular mesh or braid. The mesh or braid structure and the device may also take configurations that are intermediate between the expanded and constricted configurations, such as having a cross-sectional diameter larger than the constricted configuration but smaller than the expanded configuration. The device may switch between configurations by changing the length of the device and the mesh or braid structure. Such changes in the channel diameter can compress the specimen within the channel, thus allowing the specimen to be removed through a smaller incision than in conventional extraction bags. The mesh or braid may be made of any suitable biocompatible material, such as a second material suitable for medical applications. The second material may include, but is not limited to, fabric, plastic, suture material, metal (e.g., flat or rounded wire), or any combination thereof. In some specific aspects, the mesh may be made of polyolefins such as nylon, polyester, polyethylene and / or polypropylene, or any combination thereof.The length of the tubular mesh or braid and the device may be altered by pulling or pressing the proximal opening, distal opening, or both proximal and distal openings; by winding the mesh and elongated body material onto the ring of the proximal or distal opening; by folding or unfolding the proximal ring; or by any combination thereof. In some aspects, the woven mesh may contain braids with individual strands / threads, such as 2 to 1000 individual strands / threads, to achieve the desired ratio of length to stenosis / convergence required for optimal compression of the specimen. In some aspects, the mesh may contain helical braids.

[0011] The plurality of surface protrusions may be positioned on the inner surface of the elongated body and / or tubular mesh. In some aspects, the tubular mesh may surround the elongated body, and the plurality of surface protrusions may be positioned on the inner surface of the elongated body. In some aspects, the tubular mesh may be surrounded by the elongated body, and the plurality of surface protrusions may be positioned on the inner surface of the tubular mesh. In some aspects, the tubular mesh and the elongated body may form a single layer, and the surface protrusions may be positioned on the inner surface of that single layer. The surface protrusions may form a directionally obstructive, high-friction inner surface of the device, and the plurality of surface protrusions may be configured to contact a specimen of the subject's body drawn into the channel through the distal opening, and to allow the movement of the specimen through the channel toward the proximal opening but obstruct the movement of the specimen toward the distal opening. The multiple surface protrusions and the tubular mesh, such as in a constricted configuration, may distribute tensile tension over a larger area, thereby reducing the possibility of the surgical specimen clumping together and tearing during removal, and enabling the specimen to be removed through a relatively small incision. The inner surfaces of the elongated body and the tubular mesh may be the surfaces of the respective parts facing inward with the device.

[0012] A surface projection may have an upper edge closer to the proximal opening and a lower edge which may be closer to the distal opening. The angle formed between the upper edge and the surface on which the surface projection is located, such as the inner surface of an elongated body and / or mesh, may be 90° or less. In some surfaces, the angle formed between the upper edge and the surface on which the surface projection is located may be between 15° and 90°, or equal to any one of 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, and 90°, or between any two of these. The angle formed between the lower edge and the surface on which the surface projection is located may be 90° or more. In some aspects, the angle formed between the lower edge and the surface on which the surface protrusion is positioned may be 100° to 170°, or equal to any one of 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, and 170°, or between any two of them. The surface protrusion may have any suitable shape that can provide directional movement of the specimen along the channel. In some aspects, the surface protrusion may be hair, needle, wedge, spike, barb, hook, and / or loop. In some aspects, the surface protrusion may be part of the elongated body and / or mesh structure. In some aspects, the surface protrusion may be added to or incorporated into the elongated body and / or mesh structure by a separate element, such as a barbed thread or suture.

[0013] The subject, the subject's body parts, and the specimens derived from the subject are not part of this device.

[0014] Other aspects of the present invention are also discussed throughout this application. Any aspect discussed in relation to one aspect of the present invention may also be applicable to other aspects of the present invention, and vice versa. Each aspect described herein is understood to be an aspect of the present invention applicable to all aspects of the present invention. Any aspect discussed herein is intended to be implementable in relation to any method or composition of the present invention, and vice versa. Furthermore, the compositions and kits of the present invention may be used to implement the methods of the present invention.

[0015] The use of the words “a” or “an” may mean “one” when used with the term “comprising” in the appended claims and / or herein, but is not inconsistent with the meanings of “one or more,” “at least one,” and “one or more than one.”

[0016] Throughout this application, the term “about” is used to indicate that the value includes the standard deviation of errors in the device or method used to determine that value.

[0017] The use of the term “or” in the attached claims is used to mean “and / or” unless it is expressly indicated that it refers only to alternative options or that the alternative options are mutually exclusive; however, this disclosure supports the definition of “and / or” referring only to alternative options.

[0018] In this specification and the appended claims, the words “comprising” (and any variations of “comprising,” such as “comprise” and “comprises”), “having” (and any variations of “having,” such as “have” and “has”), “including” (and any variations of “including,” such as “includes” and “include”), or “containing” (and any variations of “containing,” such as “contains” and “contain”) are inclusive or open-ended and do not exclude any additional elements or steps of method not expressed herein.

[0019] In this specification, “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains,” “containing,” “characterized by,” or any other variation thereof, are intended to encompass the non-exclusive inclusion of the components to be described, although they are subject to any other limitations explicitly indicated. For example, a device and / or method that “includes” a list of elements (e.g., components, features, or stages) is not necessarily limited to those elements (or components, features, or stages) but may include other elements (or components, features, or stages) that are not explicitly listed or are not specific to that device and / or method.

[0020] As used herein, the transitional phrases "consists of" and "consisting of" exclude elements, steps, or components not specified. For example, "consists of" or "consisting of" as used in the appended claims limits the claim to the components, materials, or steps specifically recited therein, excluding the impurities ordinarily associated therewith (i.e., the impurities within a given component). When the phrase "consists of" or "consisting of" appears within the body of a claim clause rather than immediately following the preamble of the claim, the phrase "consists of" or "consisting of" limits only the elements (or components or steps) recited within that clause; other elements (or components) are not necessarily excluded from the entire claim.

[0021] As used herein, the transitional phrases "consists essentially of" and "consisting essentially of" are used to define a chemical composition and / or method that includes materials, steps, features, components, or elements in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristics of the claimed invention. The term "consists essentially of" occupies a middle ground between "comprises" and "consists of".

[0022] [Invention 1001] A sample collection device, A proximal opening configured to be located proximal and external to the opening in the body wall of the subject; The device has a distal opening at the end opposite the proximal opening, and is configured to be placed inside the body cavity of the target; A flexible, elongated body extending from the proximal opening to the distal opening, forming a specimen lumen along the long axis of the device; A retractable, tubular woven mesh structure that surrounds or is surrounded by the elongated body, or forms a single layer of the elongated body, and extends from the proximal opening to the distal opening, wherein the tubular woven mesh has an expanded configuration having a larger cross-sectional diameter and a narrowed configuration having a smaller cross-sectional diameter compared to the expanded configuration; A plurality of surface protrusions positioned on the inner surface of the elongated body and / or on the inner surface of the tubular mesh, configured to contact a specimen of the subject's body, which is drawn into the channel through the distal opening, and configured to allow the movement of the specimen through the channel toward the proximal opening but to obstruct the movement of the specimen toward the distal opening, and A sample retrieval device comprising, wherein the extended configuration and the narrowed configuration are interchangeable by changing the length of the device. [Invention 1002] The device of the present invention 1001, wherein the mesh structure in the extended configuration has a length of 0.01 to 5000 cm and an average cross-sectional diameter of 0.01 to 1500 cm. [Invention 1003] A device according to the present invention 1001 or 1002, wherein the mesh structure in the narrowed configuration has a length of 0.07 to 7000 cm and an average cross-sectional diameter of 0.005 to 1200 cm. [Invention 1004] A device according to any one of the invention 1001 to 1003, wherein the angle between the upper edge and the surface and / or mesh surface of the elongated body is 90° or less. [Invention 1005] A device according to any of the invention 1001 to 1004, wherein the angle formed between the lower edge of the projection and the inner surface of the elongated body and / or mesh is 90° or greater. [Invention 1006] A device according to any of invention 1001 to 1005, wherein the projection is a wedge, spike, barb, hook, or loop. [Invention 1007] A device according to any of invention 1001 to 1006, wherein the distal opening is a flexible ring configured to hold a sleeve in an open configuration for receiving a sample, and the ring is configured with a mechanism for closing the distal opening. [Invention 1008] A device according to any of the present invention 1001 to 1007, comprising a scintigraphy for closing a distal opening to contain a specimen within a sleeve. [Invention 1009] The device of the present invention 1008, wherein the cinch is a purse-string cinch, drawstring, snap, clip, zip lock, slide lock, foldable hood, or lock with interlocking edges. [Invention 1010] A device according to any of invention 1001 to 1009, wherein the proximal end of the sleeve forms a handle. [Invention 1011] A device according to any of the present invention 1001 to 1010, wherein the flexible, elongated body contains an impermeable material. [Invention 1012] A device according to the present invention 1011, wherein an impermeable material is incorporated into a woven mesh or forms a separate layer. [Invention 1013] A device according to any of the inventions 1001 to 1012, wherein the woven mesh structure is made of fabric, plastic, suture material, metal, or any combination thereof. [Invention 1014] A device according to any of the invention 1001 to 1013, wherein the mesh structure is a braided cord containing 2 to 1000 threads. [Invention 1015] A device according to any of invention 1001 to 1013, wherein the woven mesh is a diamond-shaped weave, a weave along the long axis, or a weave along the short axis. [Invention 1016] A device according to any of the invention 1001 to 1015, wherein the plurality of surface protrusions are part of a mesh structure. [Invention 1017] A device according to any one of the present invention 1001 to 1016, wherein the elongated body further includes a support structure parallel to the long axis of the body. [Invention 1018] The device of the present invention 1017, wherein the support structure is an inflatable pillar. [Invention 1019] A device according to the present invention 1018, wherein the inflatable pillar is reversibly inflatable with a gas or fluid. [Invention 1020] A device according to any of the present invention 1001 to 1019, wherein the elongated body further includes a converging structure perpendicular to the long axis of the body. [Invention 1021] Any device according to Invention 1020, wherein the converging structure is an inflatable ring or tube configured to converge a specimen within the body lumen when inflated. [Invention 1022] A device according to the present invention 1021, wherein an inflatable ring or tube is reversibly inflatable with a gas or fluid. [Invention 1023] A device according to any one of the invention 1001 to 1022, wherein the sleeve includes a distal section having a larger diameter than the proximal section of the sleeve. [Invention 1024] A sample collection device, A flexible, elongated body forming a body lumen for receiving a specimen, the body extending from a proximal opening to a distal opening in the form of a body tube along the long axis of the device, the body tube including a retractable, tubular woven mesh or braid extending from the proximal opening to the distal opening, the tubular mesh or braid having an expansion configuration and a contraction configuration, the body tube having a larger cross-sectional diameter along the cross-section of the device in the expansion configuration compared to the cross-sectional diameter in the contraction configuration, and the proximal and distal openings being configured to be sealed when a specimen is positioned within the body; A plurality of surface protrusions positioned on the inner surface of the elongated body, wherein the surface protrusions are configured to contact the specimen and allow the specimen to move through the channel toward the proximal opening but obstruct the specimen's movement toward the distal opening, and Includes, A specimen retrieval device configured to (i) be placed inside a body cavity, and (ii) be narrowed by changing the length of the device to reduce the profile of the specimen within the lumen of the device for retrieval through the body wall. [Invention 1025] The device of the present invention 1024, wherein the distal opening includes a scintillator, lasso, fold seal, zip lock seal, adhesive seal, or hood seal. [Invention 1026] A device according to the present invention 1024 or 1025, wherein the distal opening is configured to be sealed by melting or stapling. [Invention 1027] A device according to any one of the inventions 1024 to 1026, wherein the sleeve includes a distal section having a larger diameter than the proximal section of the sleeve. [Invention 1028] A device according to any one of invention 1024 to 1027, wherein the mesh structure in the extended configuration has a length of 0.01 to 5000 cm and an average cross-sectional diameter of 0.01 to 1500 cm. [Invention 1029] A device according to any of invention 1024 to 1028, wherein the mesh structure in the narrowed configuration has a length of 0.07 to 7000 cm and an average cross-sectional diameter of 0.005 to 1200 cm. [Invention 1030] A device according to any of the invention 1024 to 1029, wherein the surface protrusions are angled toward the proximal end, thereby providing proximal movement of the specimen and hindering distal movement. [Invention 1031] A device according to any of invention 1024-1031, wherein the projection is a wedge, spike, barb, hook, or loop. [Invention 1032] A device according to any of the invention 1024-1031, wherein the distal opening, proximal opening, or distal and proximal openings are configured to hold the sleeve open during sample retrieval. [Invention 1033] A device according to any of invention 1024 to 1032, comprising a locking mechanism on the distal opening. [Invention 1034] A device according to the present invention 1034, wherein the locking mechanism is a cinch lock, a drawstring, a snap, a clip, a zip lock, a slide lock, or a lock with an interlocking edge. [Invention 1035] A device according to any of invention 1024 to 1035, wherein a flexible, elongated body includes an impermeable layer. [Invention 1036] A device according to any of the invention 1024 to 1036, wherein the impermeable layer is incorporated into the woven mesh or forms a separate layer inside or outside the woven mesh. [Invention 1037] A device according to any of the inventions 1024-1037, wherein the woven mesh is made from fabric, plastic, suture material, metal, or any combination thereof. [Invention 1038] A device according to any of invention 1024 to 1038, wherein the woven mesh is a braided cord containing 2 to 1000 threads. [Invention 1039] A device according to any of invention 1024 to 1039, wherein the woven mesh is a diamond-shaped weave, a weave along the long axis, or a weave along the short axis. [Invention 1040] A device according to any of the present invention 1024 to 1040, wherein the plurality of surface protrusions are part of a woven mesh. [Invention 1041] A device according to any of the present invention 1024 to 1041, wherein the body further includes a support structure parallel to the long axis of the body. [Invention 1042] The device of the present invention 1042, wherein the support structure is an inflatable pillar. [Invention 1043] A device according to the present invention 1043, wherein the inflatable pillar is reversibly inflatable with a gas or fluid. [Invention 1044] A device according to any of the present invention 1001 to 1044, wherein the distal opening has a diameter greater than the maximum diameter of the body. [Invention 1045] An applicator configured to contain the device of the present invention 1024, the applicator forming a lumen for the device to contain the device during placement; The device of the present invention 1024 contained within the applicator and A sample collection system, including the above. [Invention 1046] A system according to the present invention 1046, wherein the proximal end of the device is functionally connected to an applicator. [Invention 1047] A system according to the present invention 1046 or 1047, wherein the applicator is configured to be inserted into a body cavity through a medical device that spans the body wall. [Invention 1048] The system of the present invention 1047, wherein the medical device that spans the body wall is a trocar. [Invention 1049] The step of positioning the device of the present invention 1001 across the body wall; The step of positioning the specimen within the lumen of the device body; The step of lengthening the device; and The step of pulling the device containing the sample out of the body cavity. A method for recovering samples from a subject, including [specific details omitted]. [Invention 1050] The method of the present invention 1049, further comprising the step of sealing the distal opening of the device. [Invention 1051] The step of placing the device of the present invention 1024 into a body cavity; The step of positioning the specimen within the lumen of the device body; A step of sealing the proximal and distal openings of the device; The step of narrowing the device; and The step of pulling the device containing the specimen out of the body cavity. A method for recovering samples from a subject, including [specific details omitted]. Other objects, features, and advantages of the present invention will become apparent from the following detailed description. However, it should be understood that the following detailed description and examples, while illustrating specific aspects of the present invention, are provided only as examples, as it will be apparent to those skilled in the art from this detailed description that various changes and modifications within the spirit and scope of the invention will become apparent from this detailed description. [Brief explanation of the drawing]

[0023] The following drawings form part of this specification and are included herein to further illustrate certain aspects of the invention. The invention may be better understood by referring to one or more of these drawings in combination with the detailed description of the specific embodiments presented herein.

[0024] [Figure 1A] A device based on one embodiment is shown. Figure 1A shows the device and tubular mesh structure in an extended configuration. [Figure 1B] A device based on one embodiment is shown. Figure 1B shows the device and tubular mesh structure in a narrowed configuration. [Figure 1C] A device based on one embodiment is shown. Figure 1C shows the device and tubular mesh structure in a narrowed configuration, and the folding of the device's foldable proximal opening ring. [Figure 1D] A device based on one embodiment is shown. Figure 1D shows the device inside the body of the subject. [Figure 2] Figures 2A to 2D show side views of surface protrusions based on four embodiments of the present invention; Figure 2A is a hair or needle, Figure 2B is a wedge, Figure 2C is a spike or angled spike, and Figure 2D is a barb or hook-shaped surface protrusion. [Figure 3]Figures 3A to 3C show top views of cross-sections of devices based on three embodiments. Figure 3A: For device 100, the mesh structure 108 surrounds the elongated body 106, and the surface protrusions 110 are located on the inner surface of the elongated body. Figure 3B: For device 200, the mesh structure 208 surrounds the elongated body 206, and the surface protrusions 210 are located on the inner surface of the mesh structure 208. Figure 3C: For device 300, the elongated body is incorporated into the mesh structure to form a single layer 308, and the surface protrusions 310 are located on the inner surface of 308. [Modes for carrying out the invention]

[0025] Detailed explanation A device according to one aspect of the present invention will be described with reference to Figure 1. The device 100 may have a proximal opening 102, a distal opening 104, an elongated flexible body 106 extending from the proximal opening 102 to the distal opening 104 and forming a channel 105 along the long axis 107 of the device, and a stencilable, tubular woven mesh structure 108 extending along the long axis 107 from the proximal opening 102 to the distal opening 104. The stencilable mesh structure may have a diamond, lateral, horizontal, or helical weave. The tubular mesh structure may be connected to an impermeable membrane that restricts the movement of cells or pathological metabolites that may be associated with tissues, organs, tumors, or other biological structures removed from a patient. The impermeable membrane may form the inner surface, outer surface, or both the inner and outer surfaces of the tubular mesh. In certain aspects, the impermeable membrane is a thin thermoplastic material. In certain aspects, the weave is such that a converging force can be applied to the contents of the tubular mesh. The converging force may be horizontal, lateral, or both horizontal and lateral. The converging force may be generated by twisting or applying torsion to the device body, proximal end, distal end, or proximal and distal end. The converging force may be used to shape the contents of the tubular mesh to aid in extraction. The elongated flexible body may have proximal, distal, or proximal and distal sealing mechanisms that seal the contents within the device body and allow manipulation of the contents to shape them for easier extraction. When both ends of the device or tubular mesh component are sealed, the channel 105 is converted into a lumen or bag for the contents. The sealing mechanism may be a cinch, lasso, folding, stapling, zip lock, hood, adhesive, clamp, thermal melting, chemical melting, or any other sealing mechanism that prevents fluid or material from spilling from the device.

[0026] Laparoscopic surgery requires the injection of carbon dioxide (CO2) into the peritoneal cavity (abdominal cavity) to create space for the surgeon to maneuver the camera and laparoscopic instruments (pneumoperitoneum). Since the extraction sleeve is a hollow cylinder, it allows for the leakage of CO2 gas. Therefore, in certain situations, the device may include a valve located within the lumen of the cylinder to prevent leakage of pressurized gas from the abdominal cavity. This valve allows for the maintenance of air pressure within the body cavity. The valve may consist of two opposing leaflets, similar to the valve on a laparoscopic trocar.

[0027] In device 100, a mesh structure 108 surrounds an elongated body 106, and 108 and 106 form separate layers. In certain aspects, a unique identifier may be woven into, printed on, or attached to the sleeve to enable identification and cataloging, etc.

[0028] Multiple surface protrusions 110 may be positioned on the inner surface 109 of the elongated body 106 to form a directionally obstructive surface. The outer surface of the elongated body may be in contact with the mesh structure 108. The proximal opening 102 may be a foldable ring. In some aspects, the ring of the proximal opening 102 may include an attachment 111, such as a handle, for holding the ring 102 and the device, and / or for folding the ring. The distal opening 104 may be a flexible ring with a changeable diameter. The device may include a lock 112 that can change the diameter of the distal opening ring. The lock may be a cinch lock, a pull cord, a snap, a clip, a zip lock, a sliding lock, or a lock with an interlocking edge.

[0029] In certain situations, the lock may be a scintillock containing a lasso 114. The diameter of the distal opening ring 104 may be varied using the lock 112 and the lasso 114. The distal opening may form a seal, such as a watertight seal, within the body cavity of the subject before the specimen is removed. The seal may be designed to contain bodily fluids and / or debris that may be discharged from the specimen as it is squeezed and withdrawn from the body. The distal opening 104 may be designed to act as a semi-rigid handle to facilitate the movement of the elongated body 106 over the specimen.

[0030] The tubular woven mesh structure may be a hollow tubular mesh with opposing ends of the tube openings, one proximal and the other distal. The tube may be symmetrical or asymmetrical. The cross-sectional diameter of the tube may remain constant along the length of the tube or may vary. The cross-sectional diameter of the tube along the length of the tube may vary symmetrically or asymmetrically / irregularly. The cross-sectional diameter of the tube at one end may be the same as, smaller than, or larger than, that of the opposite end of the tube. The cross-sectional diameter of the tube in the middle portion of the tube may be the same as, smaller than, and / or larger than that of the ends of the tube. The cross-sectional diameter of the tube, e.g., the average cross-sectional diameter, may be reduced by lengthening the tubular mesh structure. In some aspects, the woven mesh structure may contain helical braids. In some aspects, the woven mesh structure 108 may contain braids with individual strands / threads, such as 2, 10, 50, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000 strands, including 2 to 1000 strands, or all values ​​and ranges in between, to achieve a desirable ratio of length to constriction / contraction necessary for optimal compression of the specimen. In certain embodiments, design elements are utilized to stretch (e.g., the length of the specimen) and / or reduce (e.g., the width or diameter) the size of the specimen by constricting it when the specimen is contained within the sleeve. This constriction may be applied mechanically by manipulating the woven mesh to reduce or lengthen the size or inner diameter of the sleeve lumen, or hydraulically by inflating all or part of the sleeve.

[0031] In certain embodiments, the sleeve or body may incorporate inflatable tubes or pillars. In one embodiment, the inflatable tubes or pillars are configured to provide rigidity along the length of the cylinder to allow for easier drawing of the specimen into the sleeve cylinder. In other embodiments, tubes or pillars are included to provide stability or other structural support to the sleeve if necessary. The tubes or pillars may be positioned internally, externally, or both internally and externally relative to the woven mesh structure. The tubes or pillars are hollow, closed tubes or bladders that can be inflated or deflated with a gas (such as nitrogen or air) or a liquid (such as water or saline solution). There may be one, two, three, four, five, six, seven, eight, nine, ten or more inflatable tubes or pillars. Tubes or pillars may be positioned parallel to the long axis of the body, perpendicular to the long axis of the body, or spirally around the long axis of the body, at pitches of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm or cm, including all values ​​and ranges between them. Each tube or pillar may individually be 0.01 to 5000 cm in measurement along the long axis of the tube or pillar. Not all tubes or pillars need to be the same length or aligned (i.e., tubes or pillars may be in a configuration offset from one another). Tubes or pillars may be configured to be inflated individually, or as groups or subgroups. In a particular case, the terminal tubes or pillars, whether proximal, distal, or proximal and distal, may be inflated independently to close the proximal, distal, or proximal and distal openings of the sleeve or body.

[0032] The mesh structure may have both an expanded and a constricted configuration. Figure 1A shows the mesh structure and device in the expanded configuration, and Figure 1B shows the mesh structure and device in the constricted configuration. The length of the mesh structure and device may be shorter in the expanded configuration compared to the constricted configuration. The average cross-sectional diameter of the mesh structure and device along a transverse plane perpendicular to the major axis 107 may be larger in the expanded configuration compared to the constricted configuration. The mesh structure and device may also have configurations that are intermediate between the expanded and constricted configurations, such as having a cross-sectional diameter larger than the constricted configuration but smaller than the expanded configuration, and a length shorter than the constricted configuration but longer than the expanded configuration. The device may switch between configurations by changing the length of the device and mesh structure. The length of the device may be changed by pulling or pushing using the proximal 102 and / or distal 104 opening rings; and / or by rotating the edges of the mesh and the elongated body around the proximal 102 and distal 104 opening rings; or by folding the foldable proximal ring 102; or by any combination thereof. The length and cross-sectional diameter of the channel 105 may be increased or decreased in accordance with the increase or decrease in the length and cross-sectional diameter of the tubular mesh, respectively.

[0033] Figure 1C shows the mesh structure and device in a constricted configuration. The foldable proximal ring 102 can be folded and unfolded along a transverse axis perpendicular to the long axis 107 of the device, in the direction indicated by the bidirectional arrow A. The foldable proximal ring 102 may contain a hinge or similar device that enables the ring to be folded and unfolded. Figures 1A and 1B show the ring 102 in an unfolded configuration. Figure 1C shows the ring 102 folded. Figure 1C also shows the ring of the distal opening 104, which has a smaller diameter than the ring diameter in Figures 1A and 1B.

[0034] Referring to Figure 1D, the device 100 is shown inside the body cavity of the subject. The proximal opening 102 may be configured to be positioned proximal and external to the opening 118 in the body wall 116 of the subject. The device may be configured to secure a specimen 120 from the subject's body. Surface projections 110 may create a directionally obstructive surface that allows the specimen to move in the channel 105 toward the proximal opening 102, generally in the direction indicated by arrow B, but may substantially obstruct the specimen from moving in the opposite direction toward the distal opening 104. 116, 118, and 120 are not part of the device.

[0035] Surface protrusions may have similar structures, shapes, sizes, and arrangements to those discussed in US20170181767A1, which is incorporated herein by reference in its entirety. Referring to Figure 2, side views of surface protrusions based on four embodiments are shown. Non-limiting shapes of surface protrusions may include hair or needle shapes in Figure 2A, wedges in Figure 2B, spikes or angled spikes in Figure 2C, and / or barbs or hook shapes in Figure 2D. Devices having surface protrusions of various shapes may be used.

[0036] The surface projection 110 may have an upper edge or catch edge 122a-d facing the proximal opening and a lower edge or slide edge 124a-d facing the distal opening. The upper edges 122a-d may, together with the surface 109a-d on which the projection is located, such as the inner surface of an elongated body and / or a tubular mesh, form an angle 126a-d. The lower edges 124a-d may, together with the surface 109a-d, form an angle 130a-d. The angle 126a-d may be 90° or less; it may be 5°-90° or 15°-90°; or it may be equal to any one of 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, and 90°, or between any two of them. Angles 130a-d may be 90° or greater; may be 100°-170°; or may be equal to any one of 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, and 170°, or between any two of them. The upper edges 122a-d and lower edges 124a-d may contact the inner surfaces 109a-d in the straight manner shown in Figures 2A-C and / or in the rounded manner shown in Figure 2D, and angles 126a-d and 130a-d may be angles that the majority of the upper edges 122a-d and lower edges 124a-d make together with the surfaces 109a-d. The surface protrusions 110 may be arranged on the inner surfaces 109a to d in a preferred manner that can impart directional interference to the surfaces 109a to d, as described above. The arrangement may be symmetrical and / or asymmetrical. Non-limiting arrangements of surface protrusions on surfaces 109a to d may include random arrangements, circular arrangements forming circular bands on the surface, helical arrangements, zigzag arrangements, or any combination thereof.

[0037] The surface protrusions, including all values ​​and ranges between them, are at most, at least, or approximately 1 mm. 2The projections may be present on the inner surface of elongated bodies and / or mesh structures at densities of 0.1, 1, 10, 100, 1,000, 10,000, 100,000, and 1,000,000 per unit area. The projections may have a cross-section parallel to the inner surface, which may be circular, elliptical, oblate, triangular, square, rectangular, rhombic, trapezoidal, diamond-shaped, or other geometric shapes. In some respects, the wedges may have pointed, straight, or curved edges. The curved edges may curve outward from or toward the wedge. The curve may be semicircular or elliptical (similar to a cheese grater). In further considerations, the edges may be sharp enough to penetrate the surface of the sample. In certain surfaces, a projection may have a height of 0.5, 5, 50, 100, 500 μm to 1, 2, 3, 4, 5 mm, including all values ​​and ranges between them (see heights 128a-d in Figure 2 as an example). A projection may have a width or diameter of 0.1, 0.5, 5, 50, 100, 500 μm to 1, 2, 3, 4, 5 mm, including all values ​​and ranges between them (see widths or diameters 132a-d in Figure 5 as an example). In some surfaces, the width or diameter may vary or taper along the height, length, or height and length of the projection. In certain contexts, there are also various configurations in which the width or diameter refers to the cross-section at the base of the projection, and the width or diameter varies along the height of the projection; for example, the projection may taper from the base to the tip or edge. In certain contexts, the projection or texture may be molded, embossed, or etched on or within the surface.

[0038] For device 100, the mesh structure 108 surrounds the elongated body 106, but devices in which the mesh structure is surrounded by the elongated body, or the elongated body is incorporated within the mesh structure, can also be easily manufactured. Referring to Figure 3A, a top view of the cross-section of device 100 is shown along a cross-section perpendicular to axis 107. For device 100, the mesh structure 108 surrounds the elongated body 106, and the surface protrusions 110 are located on the inner surface of the elongated body. Referring to Figure 3B, a similar figure of device 200 based on another embodiment is shown, for example, a top view of the cross-section of device 200 along a cross-section perpendicular to the long axis of device 200. For device 200, the mesh structure 208 surrounds the elongated body 206, and the surface protrusions 210 are located on the inner surface of the mesh structure 208. Referring to Figure 3C, a similar figure of device 300 based on another embodiment is shown, for example, a top view of a cross-section of device 300 along a cross-section perpendicular to the long axis of device 300. For device 300, an elongated body is incorporated into a mesh structure to form a single layer 308, and the surface protrusions 310 are located on the inner surface of 308.

[0039] The sleeve may be configured to allow the specimen to be easily inserted into the sleeve or body. In certain embodiments, the convergence / expansion properties of the sleeve or body may be the only properties required to allow the specimen to be easily inserted into the sleeve or body; however, other properties / designs may be included. In certain embodiments, the body or sleeve of the device is positioned in an outwardly curled or rolled-up position. Once the specimen is introduced, the sleeve or body expands to cover the specimen. The sleeve or body may also have a bell-shaped distal opening that is wider than the specimen and a proximal portion of the sleeve or body to allow for easy access. In other embodiments, a flexible ring configured to keep the access point to the sleeve or body expanded may be positioned at the distal opening of the sleeve or body. The ring may be made of rubber or a flexible thermoplastic material that can be bent or twisted and can maintain an open configuration during operation. In certain embodiments, a closing mechanism is positioned proximal to the distal flexible ring.

[0040] In certain surgical procedures, the skin of the patient's abdominal wall is incised with a scalpel to create an incision for inserting a trocar into the abdominal cavity. The device described herein may be placed into the abdominal cavity via the trocar. The abdominal wall is made up of skin, subcutaneous tissue such as fat, and muscle tissue. In laparoscopic surgery, pneumoperitoneum is performed, in which carbon dioxide gas is injected into the abdominal cavity to stretch it. Pneumoperitoneum creates space for performing procedures in the abdominal cavity. The device may straddle the body wall but be placed entirely inside the body cavity. For placement, the device is used in conjunction with a placement device called a delivery arm. In certain cases, the device described herein may be inserted directly into the body cavity through the incision. In other cases, the device described herein may be placed via a trocar, which is typically a trocar with a diameter of 5 mm, 12 mm, or 15 mm. In certain cases, the delivery arm consists of an external sheath that holds the sleeve device in a constricted state so that the sleeve device can be delivered through the abdominal wall into the abdominal cavity. The device, when placed in the body, may contain a specimen and may allow for the convergence of the specimen to prepare it for removal from the body cavity. In certain aspects, a device placed inside a body cavity may have an opening on one end of the device to receive a specimen into the lumen. The opening may be sealed as described herein, and the specimen may be prepared for removal. In certain aspects, the device may be configured for use with a standard specimen recovery system (e.g., a bag, a traction device, and a morcellator).

Claims

1. A sample collection device, A proximal opening providing access to the body cavity of the subject, configured to be located externally to an opening in the body wall of the subject; The device has a distal opening at the end opposite the proximal opening, and is configured to be placed inside the body cavity of the object; A flexible, elongated body extending from the proximal opening to the distal opening, forming a specimen lumen along the long axis of the device; A retractable, tubular woven mesh structure that surrounds or is surrounded by the flexible elongated body, or forms a single layer of the elongated body, and extends from the proximal opening to the distal opening, wherein the retractable, tubular woven mesh structure has an expanded configuration having a larger cross-sectional diameter and a narrowed configuration having a smaller cross-sectional diameter compared to the expanded configuration; A plurality of surface protrusions positioned on the inner surface of the flexible elongated body and / or on the inner surface of the retractable tubular mesh, configured to contact a specimen of the subject's body drawn into the channel through the distal opening, and configured to allow the movement of the specimen through the channel toward the proximal opening but to obstruct the movement of the specimen toward the distal opening, and A sample retrieval device comprising an extended configuration having a length of 0.01 to 5000 cm and an average cross-sectional diameter of 0.01 to 1500 cm, and a narrowed configuration having a length of 0.07 to 7000 cm and an average cross-sectional diameter of 0.005 to 1200 cm, which are interchangeable by changing the length of the device.

2. The device according to claim 1, wherein the surface protrusions protrude from the surface of the flexible elongated body and / or the surface of the retractable, tubular woven mesh structure at an angle of 90° or less relative to the surface.

3. The device according to claim 1, wherein the surface protrusions protrude from the surface of the flexible elongated body and / or the surface of the retractable, tubular woven mesh structure at an angle of 90° or more relative to the surface.

4. The device according to claim 1, wherein the projection is a wedge, spike, barb, hook, or loop.

5. The device according to claim 1, wherein the distal opening is a flexible ring configured to hold a flexible, elongated body in an open configuration for receiving a specimen, and the flexible ring is configured to include a mechanism for closing the distal opening.

6. The device according to claim 1, comprising a scintigraphy for closing a distal opening to contain a specimen within a flexible, elongated body.

7. The device according to claim 6, wherein the cinch is a purse-string cinch, drawstring, snap, clip, zip lock, slide lock, foldable hood, or lock with interlocking edge.

8. The device according to claim 1, wherein the proximal opening has a handle.

9. The device according to claim 1, wherein the flexible, elongated body comprises an impermeable material.

10. The device according to claim 9, wherein the impermeable material is incorporated into the retractable, tubular woven mesh or forms a separate layer.

11. The device according to claim 1, wherein the retractable, tubular woven mesh structure is made of fabric, plastic, suture material, metal, or any combination thereof.

12. The device according to claim 1, wherein the retractable, tubular woven mesh is a diamond weave, a weave along the long axis, or a weave along the short axis.

13. The device according to claim 1, wherein the plurality of surface protrusions are part of a mesh structure.

14. The device according to claim 1, wherein the flexible, elongated body further includes a support structure parallel to the long axis of the body.

15. The device according to claim 14, wherein the support structure is an inflatable pillar.

16. The device according to claim 15, wherein the inflatable pillar is reversibly inflatable with a gas or fluid.

17. The device according to claim 1, wherein the flexible, elongated body further includes a convergent structure perpendicular to the long axis of the body.

18. The device according to claim 17, wherein the converging structure is an inflatable ring or tube configured to converge a specimen within the body lumen when inflated.

19. The device according to claim 18, wherein the inflatable ring or tube is reversibly inflatable with a gas or fluid.

20. The device according to claim 1, wherein the flexible elongated body includes a distal end having a diameter larger than the proximal end of the flexible elongated body.

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