Specimen Retrieval Device
20230301681 · 2023-09-28
Inventors
Cpc classification
A61B17/3423
HUMAN NECESSITIES
A61B2017/3443
HUMAN NECESSITIES
International classification
Abstract
Disclosed is a specimen retrieval device that utilizes a constricting mesh to assist with the contained retrieval of specimens during minimally invasive surgical procedures. The device can facilitate isolation and removal of specimens and allows the specimen to be removed through a smaller incision than a traditional extraction bag through constricting and elongating of the specimen by tension provided from pulling the specimen retrieval device and activating the inner woven fibers. The two-hole opening allows for optimal specimen orientation. In certain aspects the device is configured to disperse pulling tension over a larger area reducing the likelihood of specimen tearing during removal. Large specimens are safely reduced to an easily removable size and shape.
Claims
1. A specimen retrieval device comprising: a proximal opening configured to be positioned proximal and external to an opening in a body wall of a subject; a distal opening at an end of the device opposite to the proximal opening, configured to be placed inside a body cavity of the subject; a flexible elongated body extending from the proximal opening to the distal opening, forming a specimen lumen along a long axis of the device; a contractible tubular interwoven mesh structure surrounding or surrounded by the elongated body, or forming a single layer of the elongated body, and extending from the proximal opening to the distal opening, said tubular interwoven mesh having an dilated configuration having a larger cross-sectional diameter of the device and a contracted configuration having a smaller cross-sectional diameter as compared to the dilated configuration; and a plurality of surface protrusions positioned on an inner surface of the elongated body and/or an inner surface of the tubular mesh, said surface protrusions are configured to contact a specimen from the subject's body pulled into the channel through the distal opening and is configured to allow movement of the specimen through the channel towards the proximal opening but resist movement of the specimen towards the distal opening, wherein the dilated configuration and the contracted configuration are interchangeable through changing the device length.
2. The device of claim 1, wherein the mesh structure in the dilated configuration has a length of 0.01 to 5000 cm and an average cross-sectional diameter of 0.01 to 1500 cm.
3. The device of claim 1 or 2, wherein the mesh structure in the contracted configuration has a length of 0.07 to 7000 cm and an average cross-sectional diameter of 0.005 to 1200 cm.
4. The device of any one of claims 1 to 3, wherein the surface protrusions having an angle between the top edge and the surface of the elongated body and/or mesh surface is 90° or less.
5. The device of any one of claims 1 to 4, wherein the angle formed between the protrusion bottom edge and the inner surface of the elongated body and/or mesh is 90° or more.
6. The device of any one of claims 1 to 5, wherein the protrusion is a wedge, a spike, a barb, a hook, or a loop.
7. The device of any one of claims 1 to 6, wherein the distal opening is a flexible ring configured to hold the sleeve in an open configuration to receive a specimen, the ring configured with a mechanism to close the distal opening.
8. The device of any one of claims 1 to 7, wherein the device comprises a cinch to close the distal opening to contain the specimen in the sleeve.
9. The device of claim 8, wherein the cinch is a purse-string cinch, drawstring, a snap, a clip, a zip lock, a slide lock, a folding hood, or a lock with interlocking edges.
10. The device of any one of claims 1 to 9, wherein the proximal end of the sleeve forms a handle.
11. The device of any one of claims 1 to 10, wherein the flexible elongated body comprises an impermeable material.
12. The device of claim 11, wherein the impermeable material is incorporated into the interwoven mesh or forms a separate layer.
13. The device of any one of claims 1 to 12, wherein the interwoven mesh structure is made of fabric, plastic, suture material, metal or any combinations thereof.
14. The device of any one of claims 1 to 13, wherein the mesh structure is a braid comprising 2 to 1000 threads.
15. The device of any one of claims 1 to 13, wherein the interwoven mesh is a diamond shape weave, weave along the long axis, or a weave along the short axis.
16. The device of any one of claims 1 to 15, wherein the plurality of surface protrusions are part of the mesh structure.
17. The device of any one of claims 1 to 16, wherein the elongated body further comprises a support structure parallel to the long axis of the body.
18. The device of claim 17, wherein the support structure is an inflatable pillar.
19. The device of claim 18, wherein the inflatable pillar is reversibly inflatable with a gas or fluid.
20. The device of any one of claims 1 to 19, wherein the elongated body further comprises a constriction structure perpendicular to the long axis of the body.
21. The device of any one of claim 20, wherein the constriction structure is an inflatable ring or tube configure to constrict a specimen in the body lumen when inflated.
22. The device of claim 21, wherein the inflatable ring or tube is reversibly inflatable with a gas or fluid.
23. The device of any one of claims 1 to 22, wherein the sleeve comprises a distal section having a diameter that is greater than the proximal section of the sleeve.
24. A specimen retrieval device comprising: 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 a long axis of the device, the body tube comprising a contractible tubular interwoven mesh or braid extending from the proximal opening to the distal opening, said tubular mesh or braid having an dilated configuration and a contracted configuration, wherein the body tube has a larger cross-sectional diameter along a transverse plane of the device in the dilated configuration compared to the cross-sectional diameter in the contracted configuration, and the proximal and distal openings are configured to be sealed when a specimen is positioned in body; a plurality of surface protrusions positioned on an inner surface of the elongated body, the surface protrusions are configured to contact a specimen and allow movement of the specimen through the channel towards the proximal opening but resist movement of the specimen towards the distal opening, wherein the device is configured to (i) be placed inside a body cavity, and (ii) be contracted through changing the device length to reduce a profile of a specimen in the lumen of the device for removal through a body wall.
25. The device of claim 24, wherein the distal opening comprises a cinch, a lasso, a fold seal, a zip-lock seal, adhesive seal, or a hood seal.
26. The device of claim 24 or 25, wherein the distal opening is configured to be sealed by melting or stapling.
27. The device of any one of claims 24 to 26, wherein the sleeve comprises a distal section having a diameter that is greater than the proximal section of the sleeve.
28. The device of any one of claims 24 to 27, wherein the mesh structure in the dilated configuration has a length of 0.01 to 5000 cm and an average cross-sectional diameter of 0.01 to 1500 cm.
29. The device of any one of claims 24 to 28, wherein the mesh structure in the contracted configuration has a length of 0.07 to 7000 cm and an average cross-sectional diameter of 0.005 to 1200 cm.
30. The device of any one of claims 24 to 29, wherein the surface protrusions are angled to the proximal end providing for specimen movement in a proximal direction and resisting movement in a distal direction.
31. The device of any one of claims 24 to 31, wherein the protrusion is a wedge, a spike, a barb, a hook, or a loop.
32. The device of any one of claims 24 to 31, wherein the distal opening, proximal opening, or distal and proximal opening is a flexible ring configure to hold the sleeve open during specimen retrieval.
33. The device of any one of claims 24 to 32, wherein the device comprises a locking mechanism on the distal opening.
34. The device of claim 34, wherein the locking mechanism is a cinch lock, a drawstring, a snap, a clip, a zip lock, a slide lock, or a lock with interlocking edges.
35. The device of any one of claims 24 to 35, wherein the flexible elongated body comprises an impermeable layer.
36. The device of any one of claims 24 to 36, wherein the impermeable layer is incorporated into the interwoven mesh or forms a separate layer inside or outside of the interwoven mesh.
37. The device of any one of claims 24 to 37, wherein the interwoven mesh is made from a fabric, plastic, suture material, metal or any combinations thereof.
38. The device of any one of claims 24 to 38, wherein the interwoven mesh is a braid comprising 2 to 1000 threads.
39. The device of any one of claims 24 to 39, wherein the interwoven mesh is a diamond shape weave, weave along the long axis, or a weave along the short axis.
40. The device of any one of claims 24 to 40, wherein the plurality of surface protrusions are part of the interwoven mesh.
41. The device of any one of claims 24 to 41, wherein the body further comprises a support structure parallel to the long axis of the body.
42. The device of claim 42, wherein the support structure is an inflatable pillar.
43. The device of claim 43, wherein the inflatable pillar is reversibly inflatable with a gas or fluid.
44. The device of any one of claims 1 to 44, wherein the distal opening has a diameter that is greater than the maximum diameter of the body.
45. A specimen retrieval system comprising: applicator configured to contain a device of claim 24, the applicator forming a device lumen to contain the device during deployment; and the device of claim 24 contained in the applicator.
46. The system of claim 46, wherein a proximal end of the device is operably coupled to the applicator.
47. The system of claim 46 or 47, wherein the applicator is configured to be inserted into a body cavity through a medical device spanning the body wall.
48. The system of claim 47, wherein the medical device spanning the body wall is a trocar.
49. A method for retrieving a sample from a subject comprising; deploying a device of claim 1 across a body wall; positioning a specimen in the body lumen of the device; lengthening the device; and pulling the device containing the specimen from the body cavity.
50. The method of claim 49, further comprising sealing the distal opening of the device.
51. A method for retrieving a sample from a subject comprising; deploying a device of claim 24 in a body cavity; positioning a specimen in the body lumen of the device; sealing the proximal and distal opening of the device; contracting the device; and pulling the device containing the specimen from the body cavity.
Description
DESCRIPTION OF THE DRAWINGS
[0023] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of the specification embodiments presented herein.
[0024]
[0025]
[0026]
[0027]
DETAILED DESCRIPTION
[0028] Referring to
[0029] Laparoscopic surgery requires carbon dioxide (CO.sub.2) insufflation into the peritoneal (abdominal) cavity to create a space (pneumoperitoneum) for the surgeon to maneuver the camera and laparoscopic instruments. Since the extraction sleeve is a hollow cylinder, it will allow the CO.sub.2 gas to escape. Therefore, in certain aspects, the device can include a valve located in the lumen of the cylinder to prevent escape of the pressured gas from the abdominal cavity. This valve allows the pneumatic pressure in the body cavity to be maintained. The valve can be two opposing leaflets similar to the valves on a laparoscopic trocar.
[0030] In device 100 the mesh structure 108 surrounds the elongated body 106 and 108 and 106 forms separate layers. In certain aspects, a unique identifier can be woven, printed, attached to the sleeve, providing for identification and cataloging among other things.
[0031] A plurality of surface protrusions 110 can be positioned on an inner surface 109 of the elongated body 106 forming a directionally resistant surface. The outer surface of the elongated body can contact the mesh structure 108. The proximal opening 102 can be a foldable ring. In some aspects, the proximal opening 102 ring can contain attachments 111, such as handles or like, for holding the ring 102 and device, and/or folding the ring. The distal opening 104 can be a flexible ring capable of changing diameter. The device can contain a lock 112 capable of changing the diameter of the distal opening ring. The lock can be a cinch lock, a drawstring, a snap, a clip, a zip lock, a slide lock, or a lock with interlocking edges.
[0032] In certain aspects the lock can be a cinch lock containing a lasso 114. The diameter of the distal opening ring 104 can be changed using the lock 112 and the lasso 114. The distal opening can form a seal, such as a water-tight seal in a cavity of a subject prior to removal of the specimen. The seal can be designed to contain body fluids and/or debris that may be discharged from the specimen as it is squeezed and withdrawn from the body. The distal opening 104 can be designed to act as a semi-rigid handle to facilitate moving the elongated body 106 over the specimen.
[0033] The tubular interwoven mesh structure can be a hollow tubular mesh with opposite ends of the tube opening at the proximal and distal opening. The tube can be a symmetrical or an asymmetrical tube. The cross-sectional diameter of the tube can remain same or change over the length of the tube. The cross-sectional diameter of the tube over the length of the tube can change symmetrically or asymmetrically/irregularly. The cross-sectional diameter of the tube at one end of the tube can be same, smaller or bigger than the opposite end of the tube. The cross-sectional diameter of the tube at middle portions of the tube can be same, smaller and/or bigger than that at the ends of the tube. Lengthening the tubular mesh structure can reduce the cross-sectional diameter, e.g. average cross-sectional diameter of the tube. In some aspects, the interwoven mesh structure can contain helical braids. In some aspects, the interwoven mesh structure 108 can contain braids with individual strands/threads, such as 2 to 1000 or 2, 10, 50, 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000 strands/threads including all values and ranges there between, to achieve the desired length to contraction/constriction ratio needed for optimal specimen compression. Certain embodiments employ design elements for expanding (e.g., the length of a specimen) and/or reducing size of specimen (e.g., width or diameter) by constricting the specimen when contained in the sleeve. The constriction can be applied mechanically by manipulating the interwoven mesh or hydraulically by inflating all or a portion of the sleeve to reduce or lengthen the size or inner diameter of the sleeve lumen.
[0034] In certain embodiments, the sleeve or body can incorporate inflatable tubes or pillars. The inflatable tubes or pillars are configured, in one embodiment, to allow for rigidity along the length of the cylinder to permit the specimen to be pulled into the sleeve cylinder more easily. In other aspects, a tube(s) or pillar(s) is/are included to provide stability or other structural support to the sleeve when needed. The tubes or pillars can be positioned internally, externally, or internally and externally with respect to the interwoven mesh structure. The tubes or pillars are hollow, closed tubes or bladders that can be inflated or deflated with a gas (nitrogen, air, etc.) or liquid (e.g., water, saline, etc.). There can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more inflatable tubes or pillars. The tube(s) or pillar(s) can be positioned parallel to the long axis or the body, perpendicular to the long axis of the body, spiraling around the long axis of the body with a pitch of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm or cm, including all values and ranges there between. The tubes or pillars can each individually be 0.01 to 5000 cm as measured along the long axis of the tube or pillar. Not all tubes or pillars need to be the same length or aligned (i.e., the tubes or pillars can be in an off-set configuration with respect to each other. The tubes or pillars can be configured to be inflated individually, or as a group or subgroup. In a particular aspect, the terminal tubes or pillars, be it proximal, distal, or proximal and distal can be inflated independent and occlude the distal, proximal, or distal and proximal openings of the sleeve or body.
[0035] The mesh structure can have a dilated configuration and a contracted configuration.
[0036]
[0037] Referring to
[0038] The surface protrusions can have similar structure, shape, size and arrangement as of the surface protrusions as discussed in US20170181767A1, which is incorporated herein in its entirety by reference. Referring to
[0039] The surface protrusions 110 can have a top edge or a catch edge 122 a-d towards the proximal opening and a bottom edge or a slide edge 124 a-d towards the distal opening. The top edge 122 a-d can form an angle 126 a-d with the surface 109 a-d, on which the protrusions are positioned, e.g. inner surface of the elongated body and/or the tubular mesh. The bottom edge 124 a-d can form an angle 130 a-d with the surface 109 a-d. The angle 126 a-d can be 90° or less, or 5° to 90° or 15° to 90° or equal to any one of, or between any two of 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90°. The angle 130 a-d can be 90° or higher, or 100° to 170° or equal to any one of, or between any two of 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165 and 170°. The top edges 122 a-d and bottom edges 124 a-d can contact the inner surface 109 a-d in a straight
[0040] The surface protrusions can be present in the inner surface of the elongated body and/or the mesh structure at a density of at most, at least, or about 0.1, 1, 10, 100, 1000, 10,000, 100,000, 1000,000 protrusions per mm.sup.2, including all values and ranges there between. The protrusion can have cross section parallel to the inner surface that is circular, elliptical, oblong, triangular, square, rectangular, rhomboid, trapezoid, diamond, or other geometric shape. In certain respect the wedge can have a pointed, straight, or curved edge. A curved edge can curve out from the wedge or in towards the wedge. The curve can be semicircular to elliptical (similar to a cheese grater). In a further aspect the edge is sharp so that it can penetrate the surface of a sample. In certain aspects the protrusion can have a height (see height 128 a-d of
[0041] Although for device 100, the mesh structure 108 surrounds the elongated body 106, devices with the mesh structure surrounded by the elongated body or the elongated body incorporated into the mesh structure can readily be made. Referring to
[0042] The Sleeve can be configured to permit a specimen to be easily admitted within the sleeve or body. In certain embodiments, the constriction/dilation property of the sleeve or body can be the only property that is needed to allow the specimen to be easily admitted into the sleeve or body; however, other properties/designs can be included. In certain embodiments, the body or sleeve of the device is positioned in an outwardly curled, or rolled up position. When a specimen is introduced, the sleeve or body is then unfurled to cover the specimen. The sleeve or body can also have a distal bell shaped opening which is wider than the specimen and the proximal portion of the sleeve or body in order to permit easy access. In other aspects, a flexible ring can be positioned at the distal opening of the sleeve or body, configured to keep the access point to the sleeve or body dilated. The ring can be rubber or flexible thermoplastic that can bend or twist yet retain an open configuration during operation. In certain aspects, a closing mechanism is positioned proximal to the distal flexible ring.
[0043] During certain surgeries, skin of an abdominal wall of the patient is incised with a scalpel to form an incision for inserting a trocar into the abdominal cavity. A device as described herein can be deployed into the abdominal cavity via a trocar. The abdominal wall is formed of skin, subcutaneous tissue such as fat, and muscle tissue. During laparoscopic surgery, a pneumoperitoneum procedure is performed in which carbon dioxide gas is injected into the abdominal cavity to expand the abdominal cavity. The pneumoperitoneum procedure secures a space for treatment in the abdominal cavity. The device will span a body wall but it can also be fully deployed inside a body cavity. For deployment, the device will be used in conjunction with a deployment device called a delivery arm. In certain aspects, a device described herein can be directly inserted into a body cavity through an incision. In other aspects, the device described herein can be deployed through a trocar, typically a 5 mm, 12 mm, or 15 mm diameter trocar. In certain aspects the delivery arm will consist of an external sheath that keeps the sleeve device constricted to allow it to be delivered through the abdominal wall and into the abdominal cavity. The device when deployed inside body can contain specimens and provide for constriction of the specimen to prepare it for removal from the body cavity. In certain aspects, the device deployed inside the body cavity can have an opening on one end of the device to receive the specimen into the lumen. The opening can be sealed as described herein and the specimen readied for removal. In certain aspects, the device can be configured to be used with standard specimen retrieval systems (e.g., bags, retractors, morcellators, and the like).