WO2017083694A1

WO2017083694A1 - Tissue extraction devices and related methods

Info

Publication number: WO2017083694A1
Application number: PCT/US2016/061595
Authority: WO
Inventors: Frank Bonadio; Jon I. EINARSSON; Jordan Smith; Alexander ISAKOV; Debasish Pradhan; Athar Anwar SOLKAR; Mangesh Ratnakar PATANKAR
Original assignee: Lattis Surgical Inc.
Priority date: 2015-11-13
Filing date: 2016-11-11
Publication date: 2017-05-18

Abstract

In accordance with an aspect of the present disclosure, a tissue extraction device may include a bag (14) having an interior. The tissue extraction device also may include a cutting element (18) extending through the interior of the bag. The cutting element may include a strand. The cutting element also may include a cutting member on the strand. The cutting member may include an edge for cutting tissue as the cutting member is drawn across tissue.

Description

TISSUE EXTRACTION DEVICES AND RELATED METHODS

[0001 ] This application claims the benefits under 35 U.S.C. § 1 19(e) of priority to U.S. Provisional App. No. 62/255,065, filed November 13, 2015, and U.S.

Provisional App. No. 62/400,915, filed September 28, 2016, each of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] Various aspects of the present disclosure relate generally to surgical devices and methods. More specifically, the present disclosure relates to tissue extraction devices and related methods for minimally invasive surgery.

BACKGROUND

[0003] Conventional tissue extraction devices, such as laparoscopic morcellators, may include a sharp spinning blade for cutting tissue. Such devices may be inefficient and may require prolonged operating times, resulting in increased cost. Such devices also may cause unintended injuries. In some instances, conventional laparoscopic morcellators have the potential to spread occult malignancy, and this may worsen patient prognosis. Improving the design and operation of tissue extraction devices may address one or more of the

aforementioned issues.

SUMMARY

[0004] Aspects of the present disclosure relate to, among other things, tissue extraction devices and related methods. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects. [0005] It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features claimed.

[0006] As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," rather than "ideal."

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.

[0008] Fig. 1 is a side view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0009] Figs. 2A and 2B are perspective views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0010] Fig. 3 is a perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[001 1 ] Figs. 4A-4D are side views of alternative configurations of a portion of a tissue extraction device, in accordance with aspects of the present disclosure.

[0012] Figs. 5A-5D are side and perspective views of tissue extraction devices, in accordance with aspects of the present disclosure. [0013] Figs. 6A, 6B, and 7-9 are perspective views showing alternative configurations of a tissue specimen support device, in accordance with aspects of the present disclosure.

[0014] Fig. 10 is a perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0015] Figs. 1 1A and 1 1 B are front and side views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0016] Fig. 12 is a perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0017] Fig. 13 is a perspective view of a tissue specimen securing

mechanism, in accordance with aspects of the present disclosure.

[0018] Fig. 14 is a perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0019] Figs. 15A-15D are side and top views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0020] Figs. 16A and 16B are a perspective view and a close-up view, respectively, of a tissue extraction device, in accordance with aspects of the present disclosure.

[0021 ] Figs. 17A and 17B are side and front views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0022] Fig. 18 is a perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0023] Figs. 19A and 19B are perspective and side views of a tissue extraction device, in accordance with aspects of the present disclosure. [0024] Figs. 19C and 19D are perspective and semi-transparent side views of the tissue extraction device of Figs. 19A and 19B, in accordance with aspects of the present disclosure.

[0025] Figs. 19E and 19F are perspective and semi-transparent side views of the tissue extraction device of Figs. 19A and 19B, in accordance with aspects of the present disclosure.

[0026] Figs. 19G and 19H are perspective and semi-transparent side views of the tissue extraction device of Figs. 19A and 19B, in accordance with aspects of the present disclosure.

[0027] Figs. 191 and 19J are close-up perspective views of an end effector of the tissue extraction device of Figs. 19A and 19B, in accordance with aspects of the present disclosure.

[0028] Fig. 20 is a perspective view of a portion of a tissue extraction device in a partially-assembled state, in accordance with aspects of the present disclosure.

[0029] Fig. 21 is a partial section view of the portion of the tissue extraction device of Fig. 20, in accordance with aspects of the present disclosure.

[0030] Figs. 22A and 22 B are perspective views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0031 ] Figs. 23A and 23B are perspective views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0032] Fig. 24 is perspective view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0033] Figs. 25A-25C are perspective, front, and side views of a bag of a tissue extraction device, in accordance with aspects of the present disclosure. [0034] Figs. 26A-26D are perspective, front, side, and partial section views of a bag of a tissue extraction device, in accordance with aspects of the present disclosure.

[0035] Fig. 27 is a partial perspective view of a bag and strands of a tissue extraction device, in accordance with aspects of the present disclosure.

[0036] Fig. 28 is a perspective view of a bag of a tissue extraction device, in accordance with aspects of the present disclosure.

[0037] Figs. 29A-29C are perspective, front, and side views of a bag of a tissue extraction device, in accordance with aspects of the present disclosure.

[0038] Figs. 30A-30D are perspective cutaway, front, side, and section views, of a bag of a tissue extraction device, in accordance with aspects of the present disclosure.

[0039] Fig. 31 is a section view of a tissue extraction device, in accordance with aspects of the present disclosure.

[0040] Figs. 32A-32G are perspective and close-up perspective views of a tissue extraction device, in accordance with aspects of the present disclosure.

[0041 ] Figs. 33A-33D are perspective, side, and section views of a wound retractor of a tissue extraction device, in accordance with aspects of the present disclosure.

[0042] Figs. 34A-34D are top, top (with hidden lines shown), section, and close-up section views of a wound retractor of a tissue extraction device, in accordance with aspects of the present disclosure.

[0043] Figs. 34E-34K are top, perspective, and section views of a wound retractor of a tissue extraction device, in accordance with aspects of the present disclosure. [0044] Figs. 34L and 34M are top and perspective views of a wound retractor of a tissue extraction device, in accordance with aspects of the present disclosure.

[0045] Figs. 34N-34Q are top and perspective section views of a wound retractor of a tissue extraction device, in accordance with aspects of the present disclosure.

[0046] Fig. 34R is a perspective view of a component of the wound retractor of Figs. 34N-34Q, in accordance with aspects of the present disclosure.

[0047] Figs. 35A-35D are perspective views of an introducer for a tissue extraction device, in accordance with aspects of the present disclosure.

[0048] Figs. 35E-35G are side and section views of the introducer of Figs. 35A-35D, in accordance with aspects of the present disclosure.

[0049] Figs. 36A-36D are perspective views of an introducer for a tissue extraction device, in accordance with aspects of the present disclosure.

[0050] Figs. 36E-36G are side and section views of the introducer of Figs. 36A-36D, in accordance with aspects of the present disclosure.

[0051] Fig. 37A shows a perspective view of introducers for a tissue extraction device, in accordance with aspects of the present disclosure.

[0052] Figs. 37B-37E are perspective and section views of an introducer for a tissue extraction device, in accordance with aspects of the present disclosure.

[0053] Figs. 37F-37K are perspective views of an introducer for a tissue extraction device, in accordance with aspects of the present disclosure.

[0054] Figs. 37L-37P are perspective and section views of an introducer for a tissue extraction device, in accordance with aspects of the present disclosure. [0055] Figs. 37Q(i)-37Q(x) are perspective, section, semi-transparent, side, and top views of the introducer of Figs. 37L-37P, in accordance with aspects of the present disclosure.

[0056] Figs. 37Q(xi)-37Q(xiv) are partial section views of the introducer of Figs. 37Q(i)-37Q(x) in use, in accordance with aspects of the present disclosure.

[0057] Figs. 38-43 are perspective views showing exemplary introduction, tissue capturing, and tissue extracting steps, in accordance with aspects of the present disclosure.

[0058] Figs. 44A and 44B are perspective and side views showing tissue extracting steps, in accordance with aspects of the present disclosure.

[0059] Figs. 45A and 45B are perspective and side views showing tissue extracting steps, in accordance with aspects of the present disclosure.

[0060] Figs. 46A-46G are perspective views showing tissue extracting steps, in accordance with aspects of the present disclosure.

[0061 ] Figs. 46H-46W are perspective views showing tissue extracting steps, in accordance with aspects of the present disclosure.

[0062] Fig. 47A is a perspective view of a portion of a cutting element of a tissue extraction device, in accordance with aspects of the present disclosure.

[0063] Fig. 47B is a perspective view of a handle of a tissue extraction device, mounted on the portion of the cutting element of Fig. 47A, in accordance with aspects of the present disclosure.

[0064] Fig. 48 is a perspective view of handles of a tissue extraction device, in accordance with aspects of the present disclosure.

[0065] Fig. 49 is a perspective view of handles of a tissue extraction device, in accordance with aspects of the present disclosure. [0066] Figs. 50A-50E are top, perspective, close-up top, close-up side, and section views of a cutting element, in accordance with aspects of the present disclosure.

[0067] Figs. 51A-51 G are top, side, close-up top, perspective, close-up top, close-up side, and section views of a cutting element, in accordance with aspects of the present disclosure.

[0068] Figs. 52A-52G are top, side, close-up top, perspective, close-up top, close-up side, and section views of a cutting element, in accordance with aspects of the present disclosure.

[0069] Figs. 53A-53G are top, side, close-up side, perspective, close-up top, close-up side, and section views of a cutting element, in accordance with aspects of the present disclosure.

[0070] Figs. 54A-54H are top, side, close-up top, close-up side, perspective, close-up top, close-up side, and section views of a cutting element, in accordance with aspects of the present disclosure.

[0071 ] Figs. 55A and 55B are top and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0072] Figs. 56A and 56B are top and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0073] Figs. 57A and 57B are top and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0074] Figs. 58A-58C are top, side, and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0075] Figs. 59A-59D are top, close-up top, side, and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure. [0076] Figs. 60A-60C are top, side, and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0077] Figs. 61A-61 C are top, side, and perspective views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0078] Figs. 62A-62C are perspective, side, and top views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0079] Figs. 62D-62H are perspective, side, top, other side, and section views of a bead of the cutting element of Figs. 62A-62C, in accordance with aspects of the present disclosure.

[0080] Figs. 63A and 63B are perspective and top views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0081 ] Figs. 63C-63F are perspective, side, top, and section views of a bead of the cutting element of Figs. 63A and 63B, in accordance with aspects of the present disclosure.

[0082] Figs. 64A-64C are perspective, top, and side views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0083] Figs. 64D-64G are front, side, and perspective views of a blade of the cutting element of Figs. 64A-64C, in accordance with aspects of the present disclosure.

[0084] Figs. 65A and 65B are perspective and section views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0085] Figs. 66A-66E are perspective, top, side, end, and section views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0086] Figs. 67A and 67B are perspective and side views of a portion of a cutting element, in accordance with aspects of the present disclosure. [0087] Figs. 67C-67F are perspective, top, side, and end views of a bead of the cutting element of Figs. 67A and 67B, in accordance with aspects of the present disclosure.

[0088] Fig. 68 is a perspective view of a bead of a cutting element, in accordance with aspects of the present disclosure.

[0089] Figs. 69A-69E are perspective, top, side, and end views of a bead of a cutting element, in accordance with aspects of the present disclosure.

[0090] Figs. 70A-70E are perspective, top, side, end, and section views of a bead of a cutting element, in accordance with aspects of the present disclosure.

[0091 ] Figs. 71A-71 E are perspective, side, top, and end views of a bead of a cutting element, in accordance with aspects of the present disclosure.

[0092] Figs. 72A and 72 B are perspective and side views of a portion of a cutting element, in accordance with aspects of the present disclosure.

[0093] Figs. 72C-72E are perspective, side, and top views of a portion of the cutting element of Figs. 72A and 72B, in accordance with aspects of the present disclosure.

[0094] Fig. 73 is a section view of a portion of a cutting element, a cover, and a bag, in accordance with aspects of the present disclosure.

DETAILED DESCRIPTION

[0095] The present disclosure is drawn to laparoscopic tissue devices and related methods. Reference now will be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings.

Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a subject. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject. The term "approximately," when used to describe a numerical value, may be anywhere in a range of ± 5% from the numerical value.

[0096] Fig. 1 shows an exemplary tissue extraction device 10. Tissue extraction device 10 may include a shaft 12, a bag 14, a liner 16, and one or more strands 18, for performing a procedure on a tissue specimen 20. Aspects of shaft 12, bag 14, liner 16, and strands 18 are described in greater detail below.

[0097] Shaft 12 may include a proximal end, a distal end having a distal opening 24, and a lumen 22 extending between the proximal and distal ends. Shaft 12 may be made of plastic, metal, and or any other suitable biocompatible materials. Shaft 12 may have a diameter of about 5 to 50 mm, and may have a length of about 30 to 50 cm.

[0098] Strands 18 may extend through lumen 22. Proximal ends of strands 18 may be accessible to a user from the proximal end of shaft 12, and may be manipulated by the user. Distal portions of strands 18 may extend out of distal opening 24, forming loops 19. Strands 18 may include threads, fibers, and/or wires. Strands 18 be made out of polypropylene, steel, Nitinol or any other similar suitable material. It is also contemplated that strands 18 may have an abrasive and/or sharp surface to facilitate cutting of tissue. For example, surfaces of strands 18 that face tissue specimen 20 (e.g., inner surfaces of strands 18) may be abrasive and/or sharp. Additionally or alternatively, strands 18 may be covered with a coating (not shown) of silicone (or similar material) to prevent strands 18 from tearing bag 14. For example, surfaces of strands 18 that face away from tissue specimen 20 may be coated. It is also contemplated that some of strands 18 may be abrasive and/or sharp, while other strands 18 may be coated. Alternatively, one or more of strands 18 may have alternating coated and uncoated portions along its length.

[0099] Loops 19 may surround tissue specimen 20. One or more of the proximal ends of strands 18 may be manipulated by the user to cause loops 19 to cut tissue specimen 20. For example, one of the proximal ends of one of strands 18 may be fixed, or at least held in a fixed position, while the other proximal ends may be movable in a proximal direction to contract loops 19, and in a distal direction to expand loops 19. Additionally or alternatively, both of the proximal ends of each of strands 18 may be movable. For example, the one of the proximal ends may be movable in a reciprocating manner, with one end moving proximally while the other end moves distally, to cause loop 19 to move back-and-forth with a sawing motion across tissue specimen 20. It is also contemplated that both of the proximal ends may be movable proximally or distally together to contract and expand loop 19, respectively. Combinations of movements of strands 18 are also contemplated. For example, strands 18 may be moved so as to cause loops 19 to contract and reciprocate simultaneously or sequentially. It is also contemplated that strands 18 may move similarly to one another, or alternatively, different strands 18 may undergo different movements. Due to the spaced arrangement of loops 19, spaced cuts may be formed in tissue specimen 20 by loops 19, providing the user with control over the shapes and dimensions of the resulting pieces of tissue specimen 20 that are formed by the cutting.

[00100] Bag 14 may be lined by liner 16. Bag 14 may be made out nylon, polyvinyl chloride, or any other suitable material. Bag 14 may be waterproof and may completely enclose tissue specimen 20. For example, an open end 26 of bag 14 may form a seal around the distal end of shaft 12, preventing material from leaking out from within bag 14. Liner 16 may include, for example, a layer of mesh. Liner 16 may be made out of polypropylene or another suitable material. Liner 16 may provide support to tissue specimen 20 during cutting of tissue specimen 20 by strands 18, and/or may assist with extraction of tissue specimen 20. It is

contemplated that in one example, liner 16 may be omitted.

[00101 ] In use, bag 14, liner 16, and strands 18 may be deployed from the distal end of shaft 12. Shaft 12 may be introduced via an incision or through an existing orifice (e.g., a subject's vagina). When a target area (e.g., a cavity in the subject's body) is reached, bag 14, liner 16, and strands 18 may be deployed from the distal end of shaft 12. Bag 14 may be opened inside the body cavity. Tissue specimen 20 may be placed into bag 14.

[00102] Open end 26 may be pulled out of the incision/orifice, and strands 18 may be inserted into the externalized open end 26 and positioned in bag 14 and around tissue specimen 20. Alternatively, open end 26 may be grasped by a grasping instrument inserted through shaft 12, and may be pulled into shaft 12 and out of the body cavity. The grasping and pulling of open end 26 may take place either prior to or after strands 18 are extended through shaft 12 and inserted into bag 14. Alternatively, open end 26 may be brought into sealing engagement with the distal end of shaft 12 to close bag 14. For example, open end 26 may include a purse-string closure mechanism (not shown) that can be tightened around the distal end of shaft 12.

[00103] With bag 14 closed, strands 18 may be actuated by the user to cut tissue specimen 20. For example, one or more of the proximal ends of strands 18 may be pushed or pulled to engage tissue specimen 20. The pushing/pulling force may be applied using the user's hand(s), or with a mechanism (not shown) such as a ratchet or motor. The motor may include two or more pulleys that may pull intermittently in order to move loop 19 with a sawing or back-and-forth motion on tissue specimen 20. Additionally or alternatively, contraction of loop 19 may cause loop 19 to be brought against and cut into tissue specimen 20. The sawing and/or contracting may cut tissue specimen 20 inside bag 14. Liner 16 may engage tissue specimen 20 during the cutting. Once strands 18 have been actuated, and tissue specimen 20 has been cut to pieces, bag 14 and liner 16 may be pulled out of the subject with the tissue fragments contained inside. Although exemplary tissue extraction devices described below may not be depicted with bag 14 and liner 16, it should be understood that they may be used with bag 14 and liner 16.

[00104] Figs. 2A and 2B show an exemplary tissue extraction device 28. Tissue extraction device 28 may include a shaft 30, and one or more strands 32 forming one or more loops 34, similar to shaft 12, strands 18, and loops 19 (Fig. 1 ). Proximal portions of strands 32 may include concentrically arranged shafts 36. Each of loops 19 may be connected to the distal end of one of shafts 36. Shafts 36 may extend through shaft 30, and proximal ends of shafts 36 may be accessible to the user. Each of shafts 36 may be rotated individually by the user, or in combination with one or more other shafts 36, about a central longitudinal axis of shaft 30, to rotate loops 34 about the central longitudinal axis.

[00105] Fig. 2A shows tissue extraction device 28 with strands 32 deployed from shaft 30, and with loops 34 in a coplanar configuration. Coplanar loops 34 may be positioned against a tissue specimen. Fig. 2B shows tissue extraction device 28 after shafts 36 have been rotated about the central longitudinal axis of shaft 30, to rotate loops 34 so they are no longer coplanar with the other loops 34. During this rotation, loops 34 may surround the tissue specimen on a plurality of sides. Shafts 36 may be pulled proximally by the user to contract or close loops 34 to cut the tissue specimen. Shafts 36 may be pushed distally by the user to expand loops 34, facilitating the surrounding of tissue specimens by loops 34.

[00106] Alternatively, shafts 36 may be omitted. Instead, strands 32 may extend to the proximal end of shaft 30, with proximal portions of each of strands 32 positioned so as to rotate along circular paths to rotate loops 34. The circular paths of strands 32 may be concentric, to reduce or eliminate interference between adjacent strands 32. The proximal portions of strands 32 may be moved proximally or distally to engage a tissue specimen captured therein in a manner similar to strands 18.

[00107] Fig. 3 shows an exemplary tissue extraction device 40 having a shaft 42, and one or more strands 44 forming one or more loops 46, similar to shaft 12, strands 18, and loops 19 (Fig. 1 ). Loops 46 are depicted in a partially closed state, in which a gap 48 exists between loops 46. A tissue specimen may be guided through gap 48, where it may be surrounded by loops 46. The size of gap 48 may be decreased to keep the tissue specimen from exiting through gap 48. Loops 46 may be rotated relative to one another to open/close gap 48 in the manner, for example, described with respect to tissue extraction device 28. Additionally or alternatively, loops 46 may be made of a shape memory alloy, such as Nitinol, and shaped such that loops 46 may remain open until they are moved proximally to contract onto the tissue specimen and also to lessen the width of gap 48.

[00108] Figs. 4A-4D show alternative strand configurations using strands similar to strands 18 (Fig. 1 ). Fig. 4A shows a strand 50 whose proximal ends may be coupled to spools 52, 54. A distal portion 56 of strand 50 may form a spiral for encircling tissue specimen 20. A central longitudinal axis of spiral 46 may extend at an angle relative to the proximal-distal direction. For example, the central longitudinal axis may extend perpendicular to the proximal-distal direction. A shaft (not shown) may surround the portion of strand 50 between spools 52, 54 and spiral 46. The user may pull or rotate one or more of spools 52, 54 to move strand 50 in one direction, and then may pull or rotate one or more of spools 52, 54 to move strand 50 in the opposite direction, to cut tissue specimen 20 with a sawing action. Additionally or alternatively, the user may pull or rotate one of spools 52, 54 while keeping the other spool still, or may pull or rotate both spools 52, 54, to draw spiral 46 into the sheath. Movement of spiral 46 towards and/or into the sheath may cause spiral 46 to close down onto tissue specimen 20, thereby cutting tissue specimen 20. A failsafe mechanism also may be provided. For example, if strand 50 gets stuck during a procedure, one of its proximal ends can be released from spool 52 or spool 54, thereby enabling removal of strand 50 by pulling on the spooled end to entirely remove strand 50 from the proximal end of the shaft. Alternatively, both of the proximal ends of strand 50 may be released from spools 52, 54, allowing removal of strand 50 by pulling on either of its freed ends. While one strand 50 is shown, it should be understood that multiple strands 50 may be provided in one tissue extraction device to help cut tissue specimen 20 into smaller pieces.

[00109] Fig. 4B shows a strand 58 having a spiral 60 and ends connected to spools 62, 64, similar to strand 50, spiral 46, and spools 52, 54 (Fig. 4A). Spiral 60 differs from spiral 46 in that a central longitudinal axis of spiral 60 may extend parallel to the proximal-distal direction. While one strand 58 is shown, it should be understood that multiple strands 58 may be provided in one tissue extraction device. [001 10] Fig. 4C shows strands 66. Left proximal ends of each of strands 66 may be coupled to a spool 68, while right proximal ends of each of strands 66 may be coupled to a spool 70. Distal portions of strands 66 may loop around tissue specimen 20. Like spools 52, 54 (Fig. 4A), spools 68, 70 may be pushed, pulled, and/or rotated to cause strands 66 to cut tissue specimen 20. While three strands are shown, it should be understood that fewer or more strands may be used depending on the types of cuts/resulting pieces desired by the user.

[001 1 1 ] Fig. 4D shows strands 72. Each of strands 72 may have its own pair of left and right spools. For example, each of the left proximal ends of strands 72 may be coupled to one of the left spools 74, while each of the right proximal ends of the strands 72 may be coupled to one of the right spools 76. Distal portions of strand 72 may loop around tissue specimen 20. Like spools 52, 54 (Fig. 4A), spools 74, 76 may be pushed, pulled, and/or rotated to cause strands 72 to cut tissue specimen 20. Spools 74, 76 may be actuated such that strands 72 move

simultaneously to cut tissue specimen 20. Alternatively, spools 74, 76 may be actuated sequentially to cut tissue specimen 20. For example, the proximalmost strand may be pulled before the other strands, or vice-versa.

[001 12] A motor or series of motors (not shown) may be connected to spools 52, 54, 62, 64, 68, 70, 74, 76 to rotate, push, and/or pull the spools.

Alternatively, the spools may be rotated, pushed, and/or pulled by hand, for example by using a handle (not shown) having one or more ratcheting mechanisms. The configurations of the aforementioned strands may be altered based on clinical need. Moreover, different strand configurations may be usable together.

[001 13] Once the aforementioned strands have been completely pulled through tissue specimen 20, they may be removed from the body cavity. Where bag 14 (Fig. 1 ) is used, bag 14 may be pulled out of the body cavity through the incision or through the vagina, and along with bag 14, the pieces of tissue specimen 20. Additionally or alternatively, suction apparatus or a small forceps may be used to extract the pieces of tissue specimen 20.

[001 14] Figs. 5A and 5B show an exemplary tissue extraction device 78 having a shaft 80 and strands 82 forming loops 84, similar to shaft 12, strands 18, and loops 19 (Fig. 1 ). Fig. 5A shows loops 84 in a partially deployed state, where proximal portions of loops 84 are constrained by shaft 80. Figs. 5B-5D show loops 84 in a deployed state. One or more of loops 84 may be biased to deflect away from a central longitudinal axis of shaft 80 when deployed out of shaft 80. In one example, one or more of loops 84 may be made of a shape memory alloy, such as Nitinol, and may bend when exposed to heat from the subject's body. In another example, one or more of loops 84 may be made of spring steel, or some other metal, with a bend formed therein. It is also contemplated that loops 84 may have different sizes when deployed. The difference in size may provide a side having a large opening 86 for receiving a tissue specimen, and another side having a small opening 88 to act as a backstop for the tissue specimen after it passes through the large opening. The difference in size also may contour loops 84 to fit a shape of the tissue specimen. The difference in size also may produce a predetermined pattern of cuts in the tissue specimen that may be desired by the user.

[001 15] Figs. 5C and 5D also show loops 84 in their deployed states. Fig. 5C shows a connector 90 coupled to the distal ends of loops 84. Fig. 5D shows an alternative connector 91 that forms a loop that may be coupled to proximal portions and distal ends of one or more of loops 84. Connectors 90, 91 may help keep loops 84 from being bent, pulled, or otherwise deflected in unexpected or undesired ways relative to the other loops 84. Additionally or alternatively, connectors 90, 91 may engage a tissue specimen to produce additional cuts therein. Connectors 90, 91 may be made of strands of material including, for example, threads wrapped around one or more portion of loops 84. Alternatively, loops 90, 91 may be made of the same material as loops 84, and may be fastened to loops 84 or may be integrally formed with loops 84.

[001 16] Figs. 6A, 6B, and 7-9 show alternative configurations of exemplary tissue specimen support devices. The tissue specimen support devices may be extended distally out of any of the aforementioned tissue extraction device shafts, such that the tissue specimen support devices may be surrounded by the strands. Alternatively, the strands may be extended out of the tissue specimen support devices, such that the tissue specimen support devices may extend around, or surround the strands.

[001 17] Figs. 6A and 6B show a tissue specimen support device 93 having a shaft 92 with a support 94 on its distal end. Support 94 may include arms 96 arranged radially around the distal end of shaft 92. Fig. 6A shows support 94 in a delivery configuration, with arms 96 contracted radially inward. Distal tips of arms 96 may be curved such that the distal end of support 94 may be rounded or tapered in the delivery configuration, to facilitate it's insertion through narrow

openings/passages. Fig. 6B shows support 94 in a deployed configuration, with arms 96 angled radially outward. Arms 96 may be inherently biased to expand to the deployed configuration in the absence of a constraining force. Thus, arms 96 may be contained within an introducer sheath (not shown), or otherwise secured to one another, during delivery. The sheath or securement may be pulled back or otherwise removed in the body cavity to allow arms 96 to deploy. Any of the shafts of the aforementioned tissue extraction devices may act as the introducer sheath.

Alternatively, arms 96 may be made of a shape memory alloy, such as Nitinol, and may expand outward when subjected to the subject's body heat. Alternatively, arms 96 may be moved into the deployed state when the strands are deployed from the distal end of shaft 92 into the space surrounded by arms 96.

[001 18] When the strands surround a tissue specimen, and the strands are pulled to cut the tissue specimen, the tissue specimen may be pulled by the strands toward the distal end of shaft 92. Due to the relatively small diameter of the distal end of shaft 92, if the tissue specimen is compressed solely against the distal end of shaft 92 by the strands, the tissue specimen may slide off of or around shaft 92 and escape from the grasp of the strands. The chances of escape may increase if the strands are used to saw through the tissue specimen, since the sawing motion may tend to deform and/or move the tissue specimen back-and-forth or side-to-side. This unwanted escape may be prevented by support 94. When the strands pull the tissue specimen towards the distal end of shaft 92, arms 96 of support 94 may engage the tissue specimen, thus supporting a larger surface area of the tissue specimen than the distal end of shaft 92. Moreover, the angling of arms 96 may help keep the tissue specimen centered. Gaps between arms 96 may receive one or more of the strands, allowing for more complete cutting of the tissue specimen while the tissue specimen is held by arms 96.

[001 19] Figs. 7-9 show alternative tissue specimen support devices. Fig. 7 shows a tissue specimen support device 105 having a support 106 with arms 108, on a distal end of a shaft 1 10, similar to support 94, arms 96, and shaft 92 (Figs. 6A, 6B). Arms 108, however, are differently shaped, and may be formed by flat plates. Fig. 8 shows a tissue specimen support device 97 having a support 98 on a distal end of a shaft 104, support 98 having an indentation or recess 102 formed in its distal end for receiving at least a portion of the tissue specimen as the strands bring the tissue specimen toward shaft 104. Support 98 also may include a slot 100 extending therethrough in the proximal-distal direction. Slot 100 may receive one or more of the strands, such that the received strands may be able to cut entirely through the tissue specimen while the tissue specimen is engaged by support 98. Fig. 9 shows a tissue specimen support device 1 1 1 having a support 1 12 with arms 1 14. Arms 1 14 may have one or more sharp edges 1 16. Arms 1 14 may cut the tissue specimen as the strands urge the tissue specimen against arms 1 14. Additionally or alternatively, arms 1 14 may have pointed tips that may penetrate the tissue specimen as the strands draw the tissue specimen towards the shaft (not shown), to help keep the tissue specimen centered. Additionally or alternatively, gaps/slots between arms 1 14 may receive one or more of the strands, such that the received strands may be able to cut entirely through the tissue specimen while the tissue specimen is engaged by arms 1 14.

[00120] Fig. 10 shows an exemplary tissue extraction device 120 having a shaft 122 for receiving a coiled strand 124 similar to strand 50 (Fig. 4A). An arrow 126 is indicative of a pulling force exerted on one of the proximal ends of strand 124, in a proximal direction, to cause strand 124 to engage and cut tissue specimen 20.

[00121 ] Figs. 1 1A and 1 1 B show an exemplary tissue extraction device 128 having a shaft 130 and strands 132, similar to shaft 12 and strands 18 (Fig. 1 ). A curved tongue member 134 may be coupled to strands 132. For example, tongue member 134 may be coupled to distal ends of loops 136 formed by strands 132. When deployed from shaft 130, tongue member 134, through its engagement with strands 132, tongue member 134, may maintain a desired positioning of strands 132 relative to each other. For example, tongue member 134 may hold one of loops 136 open such that it is larger than the others, providing a large opening for receiving a tissue specimen. Tongue member 134 may provide a backstop for the tissue specimen after it has entered via the large opening. When strands 132 are pulled to cut the tissue specimen, tongue member 134 may prevent, or at least hinder, the tissue specimen from escaping the grasp of loops 136, by engaging the tissue specimen.

[00122] Fig. 12 shows an exemplary tissue extraction device 138 having a shaft 140 and strands 142, similar to shaft 12 and strands 18 (Fig. 1 ). Strands 142 may form loops 144. Portions of strands 142 extending away from loops 144 may be received in openings 146 in a guide member 148. When deployed from shaft 140, loops 144 may extend from openings 146 in a direction perpendicular to the proximal-distal direction. The user may pull one or more of the proximal ends of strands 18 to close loops 144 around a tissue specimen. Loops 144 may compress the tissue specimen against guide member 148, using guide member 148 as a cutting board on which to cut the tissue specimen.

[00123] Fig. 13 shows an exemplary tissue specimen securing mechanism 150 that may be used with any of the aforementioned tissue extraction devices. Tissue specimen securing mechanism 150 may be extendable from and retractable into a distal end of a shaft 156. When tissue specimen securing mechanism 150 is deployed, a tongue 152 may be positioned around a portion of the tissue specimen. A barb 154 may be extended out of shaft 156 separately from tongue 152, such that barb 154 may penetrate the tissue specimen as tongue 152 helps to hold the tissue specimen in place. Any of the aforementioned strands may be extended out of the distal end of shaft 156 to surround the secured tissue specimen, and then to cut the secured tissue specimen.

[00124] Fig. 14 shows an exemplary tissue extraction device 158 having a shaft 160 and a strand 162 forming a loop 163, similar to shaft 12, strand 18, and loop 19 (Fig. 1 ). Portions of strand 162 are shown with a coating 164 thereon. For example, a distal end of strand 162 may be uncoated to assist with cutting a tissue specimen, while proximal portions of strand 162 may be coated to prevent them from damaging bag 14 (Fig. 1 ). Tissue extraction device 158 also may include one or more reset members 166 that may be extendable out of shaft 160. After strand 162 has been pulled to cut the tissue specimen, the user may want to expand loop 163 to reposition loop 163 to cut another portion of the same tissue specimen, or to make room for receiving a different tissue specimen. The user may attempt to expand loop 163 by moving one of, or both of, the proximal ends of strand 162 in the distal direction. In some instances, however, loop 163 may be trapped in the tissue specimen, or trapped by frictional engagement between loop 163 and the inner surface of shaft 160, thus hindering or preventing the extension and expansion of loop 163. Reset members 166 may be extended from shaft 160 to penetrate the tissue specimen, to hold the tissue specimen at or near the distal end of shaft 160, while the user moves the proximal end(s) of strand 162 distally to free loop 163 from the tissue specimen, thereby allowing loop 163 to expand. Reset members 166 may include barbed ends 168 to help grip the tissue specimen. Barbed ends 168 also may provide reset members 166 with the ability to position the tissue specimen for cutting, similar to barb 154 (Fig. 13). Additionally or alternatively, reset members 166 may engage the tissue specimen and/or loop 163, and force the tissue specimen and/or loop 163 distally, to assist with moving/expanding loop 163. Reset members 166 may include enlarged distal ends (not shown) to provide an

adequately-sized contact surface for engaging the tissue specimen and/or loop 163.

[00125] Figs. 15A-15D show an exemplary tissue extraction device 170 having a shaft 172 and one or more strands 174 forming one or more loops 176, similar to shaft 12, strands 18, and loops 19 (Fig. 1 ). Portions of strands 174 are shown with a coating 177 thereon. Alternatively, portions of strands 174 may be flattened, thickened, or otherwise widened instead of having coating 176. The thicker/coated portions of strands 174 may have greater stiffness than the

thinner/uncoated portions. Fig. 15A shows strand following a curvilinear path when forming loops 176. Fig. 15B shows tissue extraction device 170 in a contracted configuration, with strands 174 adjacent one another and surrounding tissue specimen 20. Fig. 15A shows tissue extraction device 170 in an expanded configuration, with strands 174 fanned out around tissue specimen 20. Fig. 15D shows tissue extraction device 170 during cutting initiated by the user pulling on strands 174. In one example, the proximal ends of strands 174 that are connected to the uncoated/thinner portions of strands 174, may be pulled by the user, while the proximal ends of strands that are connected to the coating/thicker portions of strands 174 may remain fixed. The uncoated/thinner portions of strands 174 may cut into tissue specimen 20. The coated/thicker portions of strands 174 may not cut into tissue specimen 20, but rather, may support tissue specimen 20 to facilitate cutting by the uncoated/thinner portions of strands 174. It is contemplated that the user may initiate the pulling of strands 174 at staggered times, resulting in strands 174 being at different depths within tissue specimen 20 while simultaneously cutting tissue specimen 20, as shown in Fig. 15D. Alternatively, strands 174 may be pulled simultaneously, or sequentially one at a time. [00126] Figs. 16A and 16B show an exemplary tissue extraction device 178 having a shaft 180 and a strand 182 forming a loop 184, similar to shaft 12, strand 18, and loop 19 (Fig. 1 ). Tissue extraction device 178 also may include a tissue specimen support device 186, similar to tissue specimen support device 97 (Fig. 8). Tissue extraction device 178 may further include a proximal handle 188, and a motor 190 for pushing and/or pulling strand 182. Motor 190 may, for example, pull one of the proximal ends of strand 182 while the other of the proximal ends of strand 182 remains fixed, thus pulling strand 182 against the tissue specimen and/or across the tissue specimen, thereby cutting the tissue specimen. Motor may push one of the proximal ends of strand 182 distally in preparation for making another cut in the tissue specimen. Fig. 16B shows a close-up view of strand 182. Strand 182, as well as any of the other strands described in this disclosure, may be formed by filaments 192 that are braided in a way that provides surfaces of strand 182 with a series of protrusions and recesses that may be useful for abrading a tissue specimen when pulled against and/or across the tissue specimen. The strand 182 may cut the tissue specimen with any of its sides. Alternatively, strand 182 may be formed by a textured or coated wire with abrasive properties.

[00127] Figs. 17A and 17B show an exemplary tissue extraction device 194 having a shaft 196 and a strand 198 forming a loop 200, similar to shaft 12, strand 18, and loop 19 (Fig. 1 ). Tissue extraction device 194 also may include a grasping device 202 having opposing movable jaw members 204, 206 for clamping material therebetween. Grasping device 202 may be an alternative to the

aforementioned tissue specimen support devices. Jaw members 204, 206 may be opened to receive a tissue specimen as strand 198 is pulled to cut the tissue specimen, and jaw members 204, 206 may be closed to clamp the tissue specimen in place during cutting. Each of jaw members 204, 206 may include a slot 208 therein that may receive a portion of strand 198, so that strand 198 may more fully cut through the tissue specimen even while the tissue specimen is clamped by grasping device 202. Additional strands (not shown) may be received between and/or around jaw members 204, 206.

[00128] Fig. 18 shows an exemplary tissue extraction device 210 having a shaft 212 and strands 214 forming loops 216, similar to shaft 12, strands 18, and loops 19 (Fig. 1 ). Each of strands 214 may have a fixed end or side and an opposing movable end or side. The movable ends or sides may be operatively coupled to an actuator 218 (e.g., a motor, knob, spool, or the like), such that the user may use actuator 218 to pull the movable ends or sides. The pulling may bring strands 214 into engagement with a tissue specimen, and may do so with enough force to cause strands 214 to cut into the tissue specimen.

[00129] Figs. 19A-19J show an exemplary tissue extraction device 220. Tissue extraction device 220 may include a handle assembly 222, an outer tube 224, and an end effector assembly 226. Aspects of handle assembly 222, outer tube 224, and end effector assembly 226 will now be described in detail.

[00130] Handle assembly 222 may include a housing 228 that may be gripped by a user. Outer tube 224 may be fixedly coupled to housing 228. Housing 228 may include a first actuator 230 and a second actuator 232 (Figs. 19C-19H). Actuators 230 and 232 may include linear actuators. For example, first actuator 230 may include a motor 234, a drive shaft 236 (e.g., an externally-threaded shaft), and driven member 238 (e.g., an internally-threaded nut) movably coupled to the drive shaft 236. Motor 234 may rotate drive shaft 236, which may in move driven member 238 along drive shaft 236 in a proximal-distal direction. Motor 234 and drive shaft 236 may be fixed relative to housing 228. Second actuator 232 may be similar to first actuator 230. Second actuator 232, however, may be coupled to driven member 238, such that first actuator 230 may cause longitudinal sliding of second actuator 232 within housing 228 along a proximal-distal direction.

[00131 ] End effector assembly 226 may be coupled to second actuator 232, such that movement of second actuator 232 may move end effector assembly 226. Second actuator 232 may be positioned in various locations along the length of handle 222 and outer tube 224. A slider 242 may be linked to second actuator 232, and may provide a user with an indication of the position of second actuator 232. For example, when slider 242 occupies a position A, it may indicate that second actuator 232 is in an insertion position (Figs. 19A-19D). With second actuator 232 in the insertion position, end effector assembly 226 may be in a retracted configuration, with a distal end effector 240 received and compressed in a distal end of outer tube 224, to facilitate insertion of the distal end portion of tissue extraction device 220 into a subject. When slider 242 occupies a position B, it may indicate that second actuator 232 is in a deployment position (Figs. 19E and 19F). As second actuator 232 moves from the insertion position to the deployment position, end effector assembly 226 may be pushed distally, causing end effector 240 to deploy by extending out of the distal end of outer tube 224 and expanding from a radially- compressed configuration to a radially-expanded configuration.

[00132] Slider 242 and second actuator 232 may be coupled for movement via a lost motion coupling, such that slider 242 may slide distally from position B to a position C (Figs. 19G and 19H) while second actuator 232 stays in its deployment position. Slider 242 may be coupled to a portion of end effector assembly 226 such that movement of slider 242 to a position C may expand a side opening of end effector 226 to facilitate the insertion of tissue into end effector 226.

[00133] End effector 226 may include one or more support strands 244, one or more cutting strands 246, one or more proximal support arms 248, and a distal support 250 having one or more distal support arms 252 (Figs. 191 and 19J). Support arm 248 may include a tube or other elongate member having a first lumen 253 and a second lumen 254. First lumen 253 may receive support strand 244. Second lumen 254 may receive cutting strand 246. Support arms 248 and distal support 250 may be arranged to hold strands 244 and 246 in a U-shaped

configuration. Distal support 250 may receive distal portions of strands 244 and 246. Strands 244 and 246 may extend outwardly from a center of distal support 250, which may have a star or asterisk-like form. Distal support 250 may include a spacing member 260 (Fig. 19I) that may receive the distal portions of strands 244, to keep strands 244 spaced apart in intervals about end effector 226.

[00134] One or more of support arms 252 may include a lumen 256 for support strand 244 and a slot or groove 258 for receiving and holding cutting strand 246. Support strands 244 may be biased to move radially-outwardly in the absence of a constraining force. Thus, support strands 244 may move end effector 226 toward its expanded configuration upon exiting from outer tube 224. This may facilitate insertion of tissue into end effector 226, and into the space defined between cutting strands 246. Support strands 244 may be made, for example, of Nitinol, spring steel, and/or any other suitable material.

[00135] Second actuator 232 may be coupled to cutting strands 246 to retract cutting strands 246 proximally, thus freeing the distal portions of cutting strands 246 from slots 258. The wall of support arm 248 extending alongside second lumen 254 may be slit, perforated, or weakened to facilitate freeing of cutting strands 246 from second lumens 254. This allows cutting strands 246 to be tightened onto tissue within end effector 226. A single one of cutting strands 246 may be tightened onto the tissue at a time, or alternatively, more than one of cutting strands 246 may be tightened onto the tissue at the same time. Second actuator 232 also may move cutting strands 246 in a reciprocatory or sawing motion to cut the tissue with cutting strands 246, as described above in the aforementioned examples. It is contemplated that distal support 250 may include a spacing member 260 (Fig. 191) that may keep cutting strands 246 spaced apart from each other to avoid interference or the inflicting of damage on one cutting strand 246 by another. It is contemplated that cutting strand 246 may be braided similar to strand 182 (Fig. 16B).

[00136] Figs. 20 and 21 show another example of an end effector 262. End effector 262 may include one or more support arms 264 extending proximally from a distal support 266 (Fig. 20). One or more of support arms 264 may include a lumen 266 for support strand 244 and a slot or groove 268 for receiving and holding cutting strand 246 (Fig. 21 ). Distal support 260 may be similar to distal support 250, and may include a spacing member 270 similar to spacing member 260. End effector 262 also may include another spacing member 272 at a side of end effector 262 opposite that of spacing member 270. Spacing member 272 may include one or more cutouts 274 to position support arms 264 at spaced intervals about end effector 262.

[00137] End effector 262 may be retracted into and extended out of the distal end of outer tube 224, and/or otherwise manipulated, using handle assembly 232, in a manner similar to end effector 226. For example, Figs. 22A and 22B show end effector 262 in an extended or deployed position relative to outer tube 224. End effector 262 may be at least partially surrounded by a mesh 276, supported by support arms 264. Mesh 276 may be omitted between a pair of adjacent support arms 264 to permit insertion of tissue into end effector 262. A bag 278 may be positioned at a distal end of end effector 262. Initially, bag 278 may be

concentrically folded or otherwise collapsed (Fig. 22A). A proximal end of bag 278 may be coupled to one or more sutures 280. Suture 280 may extend proximally from bag 278 and into outer tube 224. A proximal end of suture 280 may be pulled by a user to draw bag 278 proximally over support arms 264 and mesh 276 to cover end effector 262 (Fig. 22B), for example, after tissue has been inserted into end effector 262. Bag 278 may be pulled to the distal end of outer tube 224, and/or into outer tube 224, using suture 280. Once bag 278 covers end effector 262, cutting strands 246 may be used to cut the tissue within the confines of bag 278. While end effector 262 is depicted, it should be understood that bag 278 and sutures 280 may be employed with end effector 226 in a similar manner.

[00138] Figs. 23A and 23B show another example of a bag 282 that may enclose end effector 262. A portion 284 of bag 282 may extend along outer tube 224. For example, portion 284 may extend around outer tube 224. A sheath 290 may be positioned around portion 284 to secure portion 284 on outer tube 224. Portion 284 may be slidable between the outer surface of outer tube 224 and the inner surface of sheath 290. Bag 282 may include an opening 286. Bag 282 also may include a closed end 288.

[00139] As shown in Fig. 23A, opening 286 may be positioned along a side of end effector 262, which may allow a user to insert tissue into end effector 262. For example, opening 286 may be positioned to overlap with a gap in mesh 276, and/or between support arms 264 (Figs. 22A and 22B). After the user inserts tissue into end effector 262, the user may pull portion 284 proximally to retract bag 282 into the space between sheath 290 and outer tube 224. In one example, the portion of bag 282 having opening 286 may be pulled proximally out of sheath 290. This may draw closed end 288 onto end effector 262, and with closed end 288 surrounding end effector 262, procedures may be performed on tissue within the confines of end effector 262 and closed end 288 of bag 282.

[00140] Fig. 24 shows another exemplary tissue extraction device 300. Tissue extraction device 300 may include a bag 302 for receiving a tissue specimen 308, and one or more cutting elements 304 for cutting tissue specimen 308. Cutting element 304 may include a strand (e.g., similar to strand 182 or any of the other strands described in this disclosure) or wire 305 having anchoring ends or elements 306. Tissue extraction device 300 also may include handles 310, each handle 310 including an attachment member or mechanism 312 for attaching handle 310 to one of anchoring elements 306. The elements shown in Fig. 24 may be used with an introducer (Figs. 35A-35G, 36A-36G, and 37A-370), a wound retractor (Figs. 33A- 33D, 34A-34D, and 46F-46G), and or a tube (FIGS. 46H-46W). Aspects of tissue extraction device 300 are described in greater detail below.

[00141 ] As shown in Figs. 25A-25C, bag 302 may have an open end 318 with an opening 320, and a rim 322 surrounding opening 320. Bag also may include a body 324 having a closed end 326 opposite open end 318. Bag 302 may be waterproof or otherwise leak-proof and may enclose tissue specimen 308 within a subject. Body 324 may be flexible and/or tear resistant. For example, body 324 may be made of materials including nylon, polyvinyl chloride, polyurethane, a ripstop nylon woven fabric, low-density polyethylene, and/or any other suitable material. [00142] Bag 302 may take the shape of a subject's body cavity when in use. Additionally or alternatively, bag 302 may have a predefined shape. For example, portions of bag 302 may be wider from a front view (Fig. 25B) than a side view (Fig. 25C), may be deeper or longer than it is wide, and/or may have a curved closed end 326. In one example, open end 318 may be wider than closed end 326. From the front view (Fig. 25B), a portion of body 324 proximate open end 318 may have substantially straight sidewalls, while a portion of body 324 proximate closed end 318 may have curved sidewalls. From the side view (Fig. 25C), bag 302 may have a tapering width that decreases in a direction going from open end 318 to closed end 326. Open end 318, with opening 320, may extend proximally outside of a body cavity while a procedure is performed through an incision (e.g. , a

minilaparotomy or laparoscopic procedure through the abdominal wall) or a body orifice (e.g., the vagina), and body 324 and closed end 326 may surround tissue specimen 308 in the subject's body.

[00143] A bag 302', similar to bag 302, is shown in Figs. 26A-26D. Bag 302' may comprise a stiffening element 328 at a rim 322' of an open end 318' of bag 302'. In one example, stiffening element 328 may be annular. Stiffening element 328 may be compressible to a collapsed configuration during insertion of bag 302' into and/or removal of bag 302' from the subject, and may be expandable to an expanded configuration when a compressing force is absent or removed. Stiffening element 328 may bias rim 322' and opening 320' into an expanded configuration to facilitate insertion of tissue specimen 308 into bag 302', and/or facilitate performance of a procedure on tissue specimen 308 within bag 302'.

[00144] Stiffening element 328 may be formed of, for example, Nitinol, spring steel, a polymer, and/or any other suitable material. Stiffening element 328 may be secured to the rim 322' via a band 330 formed by an everted portion of a body 324' of bag 302', and/or a piece of material attached to body 324'. Band 330 may trap stiffening element 328 between an interior surface of band 330 and an exterior surface of body 324'. Band 330 may be attached to body 324' by heat- sealing one or more ends of band 330 to body 324', creating a cavity 331 for holding stiffening element 328 (Fig. 26D).

[00145] Bag 302 may include one or more interior elements that may removably couple cutting elements 304 to the interior surface of bag 302. While bag 302 is used here as an example, it should be understood that similar interior elements may be provided in any of the other aforementioned bags. Fig. 27 shows one or more frangible, tearable, or otherwise splittable members 332 on the interior surface of bag 302. Splittable member 332 may include a strip of material 334 mounted on the interior surface of the bag 302. One or more cutting elements 304 may be secured to the interior surface of bag 302 by one or more splittable members 332, with splittable members 332 pinning strands 305 against the interior surface.

[00146] A user may exert a force on cutting elements 304 to break, tear, or otherwise split splittable members 332. Doing so may free cutting elements 304 to move relative to (e.g., away from) the interior surface of bag 302. In one example, splittable members 332 may include perforations 336 or other forms of weakening to facilitate tearing or splitting. Additionally or alternatively, splittable members 332 may include pre-formed slits (not shown) that may be force open, such that cutting elements 304 may move through the slits and away from the interior surface of bag 302.

[00147] It is contemplated that each of cutting elements 304 may be secured to the interior surface of bag 302 by multiple splittable members 332. Short or side edges of splittable members 332 may be coupled to the interior surface of bag 302 by adhesive, heat sealing, or other suitable forms of attachment. Splittable members 332 may be formed, for example, of low-density polyethylene,

polyurethane, thermoplastic, and/or other suitable materials.

[00148] Additionally or alternatively, the interior surface of bag 302 (or any of the other aforementioned bags) may include one or more channel sheaths 338 mounted thereon, as shown in Fig. 28, by which one or more of cutting elements 304 may be secured to the interior surface of bag 302. Channel sheath 338 may include one or more pieces of material that may be attached to the interior surface of bag 302. The attachment may be on lateral longitudinal sides of channel sheath 338, such that a channel 340 may be formed between attachment locations for receiving strand 305. Channel sheath 338 may be coupled to the bag 302 in the same manner as the aforementioned splittable member 332. Channel sheath 338 may have a proximal end at or near open end 318. For example, the proximal end of channel sheath 338 may terminate proximate open end 318, but distal to open end 318. A distal end (not shown) of channel sheath 338 may terminate proximate closed end 326, but proximal to closed end 326. A pair of channel sheaths 338 may be diametrically-opposed, and may secure opposite sides of a single cutting element 304, such that cutting element 304 may have a U-shaped configuration within bag 302. Because channel sheaths 338 may terminate proximal to closed end 326, the distal portion of cutting elements 304 (i.e., the base of the U) may be exposed.

Channel sheaths 338 may guide cutting elements 304 to facilitate smooth

translational, or otherwise controlled, movements, while allowing the distal portions of cutting elements 304 to engage tissue specimen 308. As shown in Figs. 29A- 29C, a channel sheath 338', similar to channel sheath 338, may be splittable in a manner similar to splittable members 332 (Fig. 27). Channel sheaths 338' may be splittable from their proximal ends to their distal ends.

[00149] Figs. 30A-30D illustrate an exemplary double-layered bag 342 that may include an outer bag or layer 344 and an inner bag or layer 346. Bag 342 may be used in place of any of the aforementioned bags, and vice-versa. A gap 348 may exist between outer layer 344 and inner layer 346. Outer layer 344 and inner layer 346 may be made of materials similar to those used in the construction of bag 302 or any of the other aforementioned bags. Outer layer 344 and inner layer 346 may be formed of a single continuous piece of material, or may be coupled at their proximal ends via adhesive, heat sealing, or the like. It is contemplated that inner layer 346 may include one or more channel sheaths 338 on its interior surface. Additionally or alternatively, inner layer 346 may include any of the other

aforementioned interior elements (e.g., splittable member 332 and/or channel sheaths 338') on its interior surface.

[00150] A double-layered bag 342' is shown in Fig. 31 . Bag 342' may be similar to bag 342. Bag 342' may include an insufflation valve 350 and a tube 352. Air, or any other suitable fluid, may be directed through valve 350, into tube 352, and into a gap 348' between an outer layer 344' and an inner layer 346' of bag 342'. Inner layer 346' may contain tissue specimen 308 and at least one cutting element 304. Outer layer 344' may form an additional barrier between contents of inner layer 346 and the body cavity. With outer layer 344' separated from inner layer 346', a procedure may be carried out on tissue specimen 308 within inner layer 346'. Due to the separation, there may be a reduced risk of puncturing outer layer 344' during performance of the procedure, and thus, a corresponding reduced risk of material from tissue specimen 308 leaking into the subject's body. In one example, inner layer 346' may have a greater stiffness than outer layer 344', such that insufflation pressure in gap 348' may be less able/likely to cause inner layer 346' to collapse around tissue specimen 308, thereby giving the user a better view of tissue specimen 308 and more of a working area; and more able/likely to move outer layer 344' away from inner layer 346' to guard against damaging outer layer 344'.

[00151 ] In another example, a double layered bag 354 is shown in Figs. 32A-32G. Bag 354 may be used in place of any of the aforementioned bags, and vice-versa. Bag 354 may include an outer layer 355 having an outer neck or rim 356 and an outer body 357. Bag 354 also may include an inner layer 358 having an inner neck or rim 359 and an inner body 360. Inner body 360 may be a mesh or net. In one example, inner body 360 may be made of Nitinol or spring steel, such that inner body 360 may be inherently biased to expand outwardly when deployed from any suitable introducer. Alternatively, inner body 360 may be made of a polymeric material, or woven material, that may exhibit elastic properties. Outer rim 356 may receive inner rim 359 such that outer rim 356 may concentrically surround inner rim 359. Inner rim 359 may extend distally beyond outer rim 356. Outer rim 356 and inner rim 359 may be removably coupled to each other by one or more frangible, tearable, or otherwise separable connections 361 to form a separation line, such that inner rim 359 may be separated from outer rim 356 by pulling rims 356 and 359 away from each other at the separation line (Figs. 32C-32G). The separation line may be formed at the proximal ends of rims 356 and 359, such that the proximal ends of rims 356 and 359 are, at least initially, flush with each other.

[00152] One or more gripping members 362 may extend from outer rim 356. Gripping member 362 may include a holding tab, ring, or other enlarged portion 363 and a strand 364. A user may pull gripping member 362 and strand 364 to facilitate withdrawal of the proximal end of bag 354 out of a subject's body. Once the proximal end of bag 354 is outside of the subject's body, rims 356 and 359 may be separated. The separation may help keep inner layer 358 (holding tissue specimen 308) away from outer layer 355 while tissue specimen 308 is being cut by cutting element 304.

[00153] One or more splittable members 365 may be provided along the interior of inner layer 358. Splittable member 365 may include an enlarged splittable proximal portion 366, for receiving anchoring element 306 of cutting element 304, and a narrower splittable distal portion 367, for receiving strand 305 of cutting element 304. Splittable member 365 may be similar to, for example, splittable members 332 and 338'. For example, splittable member 365 may split, tear, break, or otherwise separate along a split 368. Split 368 may include perforations, frangible portions, pre-formed slits, and/or any other suitable elements to facilitate splitting. Splittable member 365 may be secured to inner layer 358 using any suitable form of attachment. For example, portion 366 of splittable member 365 may be heat-sealed, adhered, or otherwise attached to the interior surface of inner rim 359.

[00154] Figs. 33A-33D illustrate aspects of a wound retractor 369.

Wound retractor 369 is shown in use with bag 302. It should be understood, however, that wound retractor 369 may be used with any of the other

aforementioned bags. Wound retractor 369 may be collapsible (radially-inwardly) and expandable (radially-outwardly), and may have overlapping ends 370 and 371 . For example, wound retractor 369 may form a spiral that may be selectively radially compressed or radially expanded in order to decrease or increase the diameter of wound retractor 369. [00155] Wound retractor 369 may have an hourglass-shape. Sides of wound retractor 369 may be concave to receive margins of a bodily orifice or incision in a subject, thereby helping to secure wound retractor 369 in position. Wound retractor 369 may be inserted along a portion of bag 302 passing through a bodily orifice or incision to secure bag 302 relative to the bodily orifice opening or incision, ensure a working space 372 remains open during a procedure, and/or protect the margins of the bodily orifice or incision from potentially being injured by cutting elements 304 during performance of the procedure. Wound retractor 369 also may provide a counter force on tissue specimen 308 when the user exerts a pulling force on tissue specimen 308 during cutting with cutting elements 304. Wound retractor 369 may be made of a flexible metal, a flexible and/or elastic polymer, semi-rigid plastic, Nitinol, spring steel, and/or other suitable materials.

[00156] Wound retractor 369 may include one or more clips 373 positioned at or near a proximal end of wound retractor 369. Clips 373 may be used to secure cutting elements 304 (Fig. 33B) so cutting elements 304 do not become tangled or otherwise interfere with each other during use, are positioned for easy access by the user, and/or remain selectively maneuverable from outside bag 302. Clip 373 may protrude from an inner surface of wound retractor 369, and may include a cantilevered arm 374 that extends over cutting elements 304. Clip 364 may punched out of the wall of wound retractor 369, or formed in any other suitable manner. Diametrically-opposed pairs of clips 364 may be positioned around wound retractor 369, such that opposing clips 364 may hold opposite end portions of a single U-shaped cutting element 304.

[00157] Wound retractor 369 also may include at least one radially- outward facing engagement member 375 and at least one radially-inward facing engagement member 376. Each engagement member 375 and 376 may include a sloped portion 377 and a shoulder 378. The shoulders of engagement members 375 and 376 may engage to releasably set the diameter of wound retractor 369.

Moreover, wound retractor 369 may include multiple engagement members 376 to provide multiple diameter settings. Engagement member 375 and engagement member 376 may be positioned at or near a central portion of wound retractor 369. The adjustability of size and/or shape of wound retractor 369 may allow wound retractor 369 to adjustably set the size and/or shape of the bodily orifice or incision of a subject into which wound retractor 369 is inserted.

[00158] Radially-outward facing engagement member 375 and radially- inward facing engagement member 376 may be connected to, or may be positioned proximate to, a stiffening element 378 of wound retractor 369. Stiffening element 378 may include, for example, an annular metal member, while other portions of wound retractor 369 may be made of silicone. Engagement members 375 and 376 may be on opposite sides of stiffening element 378, such that the shoulders of engagement member 375 and 376 may engage to releasably lock engagement members 375 and 376. Although engagement members 375 and 376 are depicted as wedge-shaped or triangularly-shaped protrusions, it should be understood that any paired shapes that releasably lock to each other may be used.

[00159] Wound retractor 369 may be inherently radially-inwardly biased to move towards a contracted configuration in the absence of an expanding or holding force. Engagement between engagement members 375 and 376 may maintain wound retractor 369 in an expanded configuration. Alternatively, wound retractor 369 may be inherently radial ly-outwardly biased to move towards an expanded configuration in the absence of a constraining or holding force, in which case the orientation of the sloped and shoulder surfaces of engagement members 375 and engagement members 376 may be reversed.

[00160] Another wound retractor 379 is illustrated in Figs. 34A-34D. Wound retractor 379 may be similar to wound retractor 369. Wound retractor 379 may include at least one extension 380 and at least one aperture 381 . Extension 380 may be cylindrical, or any other suitable shape, and may include a protrusion 375 extending from its side (Fig. 34D). Aperture 381 may include a hole or indentation sized/shaped to releasably receive and hold extension 380. Protrusion 375 may facilitate releasable securement of extension 380 in aperture 381 by providing a snap-fit engagement of extension 380 in aperture 381 .

[00161 ] Wound retractor 379 may include a plurality of apertures 381 extending along a radial plane that passes through wound retractor 379. Positioning extension 380 in one of apertures 381 may serve to retain the size and/or shape of wound retractor 379, and thus, retain the size and/or shape of the bodily orifice or incision in which wound retractor 379 may be positioned. Moreover, the presence of multiple apertures 381 provides for selective adjustment of a width of wound retractor 379, adjustment of the size and/or shape of the bodily orifice or incision, and/or adjustment of the size and/or shape of working space 372.

[00162] Wound retractor 379 also may include at least one holding feature 382 extending radially-outwardly to provide a user with something to grasp or hold for manipulating wound retractor 379. In one example, wound retractor 379 may include two holding features 382 extending proximally and radially-outwardly. One holding feature 382 may extend from an outer end of the spiral formed by wound retractor 379, and the other holding feature 382 may extend from an inner end of the spiral formed by wound retractor 379. Holding feature 382 may be a tab. Extension 380 may be aligned with one of holding features 382, assisting a user with positioning the extension 380 in apertures 381 .

[00163] Alternatively, a tube (not shown) may be used in a similar manner as the aforementioned wound retractors. For example, the tube may be used in a procedure through an existing bodily orifice (e.g., a subject's vagina), to line the margins of the bodily orifice. In one aspect, the tube may be used to protect the vaginal walls and/or to retract the vaginal walls. The tube may include a hollow elongate device with a diameter large enough to receive any of the aforementioned bags and cutting elements. The shape/size of the tube may differ from the shape size of the aforementioned wound retractors to accommodate the shape/size of the bodily orifice into which the tube is inserted.

[00164] Another wound retractor 600 is shown in Figs. 34E-34K. Wound retractor 600 may be used with any of the bags described in this disclosure, including, for example, bag 354. Wound retractor 600 may include a proximal flange 602. Proximal flange 602 may be annular, with a central opening 603. Wound retractor 600 also may include one or more clips 604 positioned adjacent a radially- outer edge of proximal flange 602. Clips 604 may be spaced from each other at equal intervals. Clips 604 may be similar to clips 373 (Figs. 33A and 33B), and may help secure strands 305 of cutting elements 304. Additionally or alternatively, wound retractor 600 may include one or more engagement elements or hooks 606 at the radially-outer edge of proximal flange 602. Hooks 606 may be spaced from each other at equal intervals. Hooks 606 may be similar to hooks 345 (Figs. 46F and 46G), and may engage the mesh or netting forming inner layer 358 of bag 354. Hooks 606 may be positioned between clips 373 to help ensure that when strands 305 are secured in clips 604, hooks 606 may be positioned to engage portions of inner layer 358 between splittable distal portions 367 of splittable members 365.

[00165] Wound retractor 600 also may include a tubular member 608 extending distally from proximal flange 602. Tubular member 608 may include a wall 610 surrounding a central passage 612. Tubular member 608 may connect proximal flange 602 with a distal inflatable member 614. Distal inflatable member 614 may include, for example, a toroidal balloon. FIGS. 34H and 34J show distal inflatable member 614 in an uninflated state, while FIGS. 34I and 34K shows distal inflatable member 614 in an inflated state. Distal inflatable member 614 may be in the uninflated state to facilitate insertion of wound retractor 600 into a wound opening. Wound retractor 600 may be inserted into a wound opening until distal inflatable member 614 passes through the wound opening, and/or until further insertion is prevented by a proximal end portion of tubular member 608 and/or a distal-facing surface of proximal flange 60. Distal inflatable member 614 may then be inflated to secure wound retractor 600 relative to the wound opening. For example, the inflated distal inflatable member 614 may prevent withdrawal of wound retractor 600 out of the wound opening.

[00166] Wound retractor 600 may include an insufflation assembly 616 for inflating and/or deflating distal inflatable member 614. Insufflation assembly 616 may include, for example, an insufflation valve 618 and an insufflation lumen 620. Insufflation valve 618 may move between open and closed positions to control the flow of an insufflation fluid through insufflation lumen 620. Insufflation lumen 620 may include an external tubular portion 622. Insufflation lumen 620 also may include an internal portion 624. Internal portion 624 may include a passage extending through proximal flange 602 and wall 610 of tubular member 608 to distal inflatable member 614.

[00167] Another wound retractor 626 is shown in Figs. 34L and 34M. Wound retractor 626 may be similar to wound retractor 600, and may include a proximal flange 628, a central opening 630, one or more clips 632, a tubular member 634, a central passage 635, a distal inflatable member 636, an insufflation assembly 638, and one or more hooks 642. A difference between wound retractor 626 and wound retractor 600 is that wound retractor 626 may include one or more adjustable hook assemblies 640. Adjustable hook assembly 640 may include hook 642, which may be similar to hook 606. Hook 642 may be fixedly coupled to a slidable member 644. Slidable member 644 may be slidable along a proximal-facing surface of proximal flange 628, and may be slidably received by a case or housing 646.

Slidable member 644 may include protrusions or teeth 648 on a proximal-facing surface thereof. Housing 646 may include a pawl (not shown) therein that may form a ratchet with teeth 648. A radial position of hook 642 may be adjusted by sliding slidable member 644 along the proximal-facing surface of proximal flange 628 and through housing 646 until the desired radial position is reached. The radial position may be locked or otherwise maintained by engagement between the pawl and one or more of teeth 648. It is contemplated that wound retractor 626 may include a plurality of adjustable hook assemblies 640, with each hook assembly 640 being independently adjustable. This may allow hooks 642 to engage the mesh or netting forming inner layer 358 of bag 354 when used in wound openings of different sizes and/or shapes.

[00168] Another wound retractor 650 is shown in FIGS. 34N-34Q.

Wound retractor 650 may be similar to wound retractor 626, and may include a proximal flange 652, a central opening 654, one or more clips 656, a tubular member 658, a central passage 660, and one or more adjustable hook assemblies 662.

Adjustable hook assembly 662 may include a hook 664, a slidable member 666 with teeth 668, a housing 670, and a pawl (not shown) in housing 670, that may be similar to hook 642, slidable member 644, teeth 648, housing 646, and the pawl of adjustable hook assembly 640. One difference is that hook 664 may have a different shape than hook 642, and/or housing 670 may be positioned more radially-inward along proximal flange 652 than housing 646 on proximal flange 628.

[00169] Tubular member 658 may have an adjustable width or diameter. To achieve this, tubular member 658 may include a plurality of petals 672. As shown in Fig. 34R, each petal 672 may include a curved panel defining a portion of tubular member 658. For example, each petal 672 may include two pairs of parallel curved edges, the edges of each pair being perpendicular to the edges of the other pair. Each petal 672 may include a central region 673 that may be thicker than side regions 675 on each side of the central region. Side regions 675 may be more flexible than central region 673.

[00170] Each petal 672 may be coupled to a slidable member 674 having teeth 676, similar to slidable member 644 and teeth 648. Slidable member 674 may be slidably received within a housing 678 having a pawl (not shown), similar to housing 672. The pawl and teeth 676 may form a ratchet.

[00171 ] To facilitate insertion of wound retractor 650 into a wound opening, tubular member 658 may be held in a collapsed state, as shown in Fig. 34P. In the collapsed state, edge portions of each of petals 672 may overlap with edge portions of adjacent petals 672. For example, side regions 675 of each of petals 672 may overlap with side regions of adjacent petals 672. After tubular member 658 is positioned within the wound opening, petals 672 may be moved radially outwardly by sliding slidable members 674 through housings 678. Petals 672 may be slid radially outwardly until a desired retraction of the wound opening is achieved. The radial position may be locked or otherwise maintained by

engagement between the pawls of housings 678 and teeth 648 of slidable members 674. The position of each petal 672 may be independently set/adjusted. Fig. 34Q shows tubular member 658 in an expanded state with petals 672 no longer overlapping each other.

[00172] Figs. 35A-35G illustrate aspects of an exemplary introducer 383. Introducer 383 may be used to introduce any of the aforementioned bags and cutting elements into a body cavity via an incision (e.g. , through an abdominal wall) or existing bodily orifice (e.g., a subject's vagina). Introducer 383 may include a hollow elongate member 384 and a pusher or plunger 385. Hollow elongate member 384 may include a grip portion 386, a distal end 387 having a distal opening 388, and a proximal end 390 having a proximal opening 392. Distal end 387 may taper distally to facilitate insertion of elongate member 384 through the incision or bodily orifice. Distal end 387 also may include a plurality of flexible projections 393 that allow for distal end 387 to expand from a narrow, undeployed configuration (Figs. 35A, 35B, 35E, and 35F), to a wider, deployed configuration (Figs. 35C, 35D, and 35G).

Proximal opening 392 may be flared to facilitate insertion of the bag, cutting elements, and/or pusher 385. Pusher 385 may include a solid elongate member that is configured to slide through hollow elongate member 384 to distally push the contents of hollow elongate member 384 toward and out of distal opening 388.

Pusher 385 also may have an enlarged proximal end 394 to facilitate pushing by the user. [00173] Figs. 33A-34C illustrate another example of an introducer 396 that is similar to the introducer 383, except that introducer 396 may include an elongate member 384', similar to elongate member 384, but having a flat or otherwise blunt tip 397 without flexible projections 393. The absence of flexible projections 393 may allow a bag and cutting elements to be inserted into introducer 396 via openings at either of its ends. Fig. 37A illustrates another exemplary introducer 398 similar to introducers 383 and 396, including an elongate member 400 with an open distal end 402 and a metallic pusher 404. Here, elongate member 400 may be at least partially transparent or see-through. Metallic pusher 404 may include a thin stem 406 with an enlarged distal end 408 to push a bag and cutting elements distally out of elongate member 400.

[00174] Figs. 37B-37E illustrate another example of an introducer 399a. Introducer 399a may be used to introduce any of the aforementioned bags and cutting elements into a body cavity via an incision or existing bodily orifice.

Introducer 399a may include a hollow elongate member 401 a. Hollow elongate member 401 a may include a proximal section 403a and a distal section 405a, at least one of which may have a tubular cross-sectional shape. When assembled to each other, proximal section 403a and distal section 405a may receive any of the aforementioned bags and cutting elements, and may constrain the bags and cutting elements in a collapsed configuration.. Hollow elongate member 401 a may receive a pusher 409a, which may be similar to any of the aforementioned pushers. Pusher 409a may be inserted into an opening 415a, and may slide through hollow elongate member 401 a, to distally push the contents of hollow elongate member 401 a toward and out of a distal opening 41 1 a. Distal section 405a may include a tapered distal end 419a to make it easier for the user to insert hollow elongate member 401 a through the incision or existing bodily orifice of the subject.

[00175] Proximal section 403a and distal section 405a may be removably coupled (Fig. 37B) via a twist lock mechanism 407a at a distal end of proximal section 403a and a proximal end of distal section 405a. Once the bag and cutting elements have been deployed in the body cavity, the user may disengage twist lock mechanism 407a to uncouple proximal section 403a from distal section 405a (Fig. 37C). The user may remove proximal section 403a and plunger 409a from the subject. Distal section 405a may remain in the incision or existing bodily orifice. The subject's body cavity may be insufflated via distal section 405a. A cap 421 a may be used to cover a proximal end of distal section 405b to maintain the insufflation pressure in the body cavity. Cap 421 a may include an opening 423a for receiving an instrument (not shown), and forming a seal with an outer surface of the instrument to reduce leakage of the insufflation gas from the body cavity. The instrument may include, for example, a forceps or grasper inserted through distal section 405b to manipulate the bag and/or tissue (Fig. 46A).

[00176] Figs. 37F-37K illustrate another example of an introducer 399b. Introducer 399b may be used to introduce any of the aforementioned bags and cutting elements into a body cavity via an incision or existing bodily orifice.

Introducer 399b may be similar to introducer 399a. Introducer 399b may include a hollow elongate member 401 b including a tubular proximal section 403b and a tubular distal section 405b. Hollow elongate member 401 b may slidably receive a pusher 409b (Figs. 37F and 37H). Distal section 405b may be blunt or flat to reduce the likelihood of a user accidentally damaging tissue during use of introducer 399b. [00177] Distal section 405b may include a securing member 425b.

Securing member 425b may include a cuff fixedly attached to a radially-outer tubular surface of distal section 405b. Securing member 425b may include enlarged proximal and distal portions, connected by a narrow intermediate portion.

Additionally or alternatively, securing member 425b may have an hourglass shape. Securing member 425b may be positioned in an incision or aperture in the subject, with its enlarged proximal and distal portions on opposite sides of the incision/orifice. In one example, securing member 425b may be inflatable. For example, securing member 425b may be inserted into the incision/orifice in a deflated state, to facilitate insertion of securing member 425b into the incision/orifice. Securing member 425b may then be inflated to enlarge its proximal and distal portions, thereby firmly seating securing member 425b and distal section 405b in the incision/orifice. An inflation fluid may be introduced into securing member 425b via one or more lumens (not shown) extending along or through distal section 405b, or distal section 405b and proximal section 403b. Securing member 425b may be deflated to facilitate removal of distal section 405b from the incision/orifice.

[00178] Proximal section 403b and distal section 405b may be removably coupled (Fig. 37F) via a push-button lock mechanism 407b. Once the bag and cutting elements have been deployed in the body cavity, the user may actuate push-button lock mechanism 407b to uncouple proximal section 403b from distal section 405b (Figs. 37G and 37K). Distal section 405b may remain in the incision or existing bodily orifice, secured there with the help of securing member 425b. The subject's body cavity may be insufflated via distal section 405b. A cap 421 b (Figs. 37I and 37J), similar to cap 421 a, may be used to cover a proximal end of distal section 405b to maintain the insufflation pressure in the body cavity, and to sealingly receiving an instrument, for example a forceps or grasper used to manipulate the bag and/or tissue (not shown). Engagement between securing member 425b and the incision/orifice also may help maintain the insufflation pressure in the body cavity.

[00179] Figs. 37L-37P illustrate another example of an introducer 399c. Introducer 399c may be used to introduce any of the aforementioned bags and cutting elements into a body cavity via an incision or existing bodily orifice.

Introducer 399c may be similar to introducer 399a and/or introducer 399b.

Introducer 399c may include a hollow elongate member 401 c including a tubular proximal section 403c and a tubular distal section 405c (Fig. 37L). Hollow elongate member 401 c may slidably receive a pusher 409c. Distal section 405c may include a tapered distal end 419c to make it easier for the user to insert hollow elongate member 401 c through the incision or existing bodily orifice of the subject.

[00180] Distal section 405c may include a securing member 425c. Securing member 425c may include an enlarged, tapered region at a proximal portion of distal section 405c. Securing member 425c may include external threading 427c for screwing distal section 405c into an incision or aperture in the subject, thereby securing distal section 405c in position relative to the incision/orifice via engagement between external threading 427c and tissue surrounding the incision/orifice. Securing member 425c may be screwed out of the incision/orifice when it is no longer needed.

[00181 ] Proximal section 403c and distal section 405c may be removably coupled (Fig. 37L) via a threaded connection 407c. For example, a proximal end of distal section 405c may include internal threading 429c for receiving/engaging external threading (not shown) at a distal end of proximal section 403c. Once the bag and cutting elements have been deployed in the body cavity, the user may screw proximal section 403c out of distal section 405b. Distal section 405b may remain in the incision or existing bodily orifice, secured there with the help of external threading 427c. The subject's body cavity may be insufflated via distal section 405c. A cap 421 c (Figs. 37N-37P), similar to cap 421 a and/or cap 421 b, may be used to cover a proximal end of distal section 405c to maintain the insufflation pressure in the body cavity, and to sealingly receiving an instrument, for example a forceps or grasper used to manipulate the bag and/or tissue (not shown). Engagement between external threading 427c and the incision/orifice also may help maintain insufflation pressure in the body cavity.

[00182] Figs. 37Q(i)-37Q(x) also illustrate aspects of introducer 399c. Distal section 405c may include an annular shoulder 680. Annular shoulder 680 may engage a distal end 682 of proximal section 403c to stop proximal section 403c from being further inserted into distal section 405c. For example, annular shoulder 680 may engage distal end 682 to prevent external threading 684 of proximal section 403c from passing through and exiting from internal threading 429c (Fig. 37Q(ii)) of distal section 405c.

[00183] As shown in at least Figs. 37Q(i), 37Q(vii), and 37Q(viii), proximal section 403c may include gripping elements 686 on a proximal end portion thereof. Gripping elements 686 may be held by the user when inserting proximal section 403c into distal section 405c, which may entail sliding proximal section 403c into distal section 405c and/or rotating proximal section 403c relative to distal section 405c. Proximal section 403c may be transparent for visibility therethrough during deployment of any of the aforementioned bags, which may be housed in a lumen 694 (Fig. 37Q(viii)) of proximal section 403c. [00184] As shown in at least Figs. 37Q(ix) and 37Q(x), pusher 409c may include an enlarged proximal portion 688, a ribbed shaft 690, and an enlarged distal portion 692. As shown in Fig. 37Q(i), when proximal section 403c is fully inserted into distal section 405c, and pusher 409c is fully inserted into proximal section 403c, enlarged distal portion 692 may protrude distally from tapered distal end 419c.

Enlarged distal portion 692 may terminate at a flat distal end face 693 (Fig. 37Q(x)).

[00185] As shown in at least Figs. 37Q(iii)-37Q(vi), cap 421 c may include a grip or tab 696 on its periphery. The user may hold tab 696 to facilitate placement of cap 421 c onto a collar 698 (Fig. 37Q(ii)) at the proximal end of distal section 405c, and/or removal of cap 421 c from collar 698. Cap 421 c may be made of an elastomeric material having a port 700 (Fig. 37Q(v)) through which an endoscope or any other suitable instrument may be inserted. Cap 421 c may help maintain insufflation pressure in the body cavity after the bag is deployed. For example, cap 421 c may include a valve system, such as a lip seal, for sealingly engaging an outer surface of the endoscope while maintaining insufflation pressure in the body cavity. It is also contemplated that the valve system may include an additional seal or seals to maintain insufflation pressure even if the endoscope is not inserted into cap 421 c.

[00186] Figs. 37Q(xi)-37Q(xiv) show introducer 399c in use. Fig.

37Q(xi) shows distal section 405c in a wound opening 702 in tissue 704, proximal section 403c in distal section 405c, and pusher 409c in proximal section 403c. Fig. 37Q(xii) shows the same view of introducer 399c as Fig. 37Q(xi), but in Fig. 37Q(xii) a bag 706 is depicted, while in Fig. 37Q(xi) bag 706 is not shown so that more of introducer 399c is visible. After bag 706 has been deployed, proximal section 403c and pusher 409c may be removed from distal section 405c. Distal section 405c may remain in wound opening 702, as shown in Fig. 37Q(xiii). Cap 421 c may be coupled to distal section 405c to maintain insufflation pressure in the body cavity. Fig.

37Q(xiv) shows an endoscope 708 inserted through port 700 of cap 421 c. Cap 421 c may sealingly engage the outer surface of endoscope 708 at port 700.

[00187] The distal sections of introducers 399a, 399b, 399c, and 399d, which may remain in the incision/orifice after deployment of the bag and cutting elements, may be removed after tissue specimen 308 has been inserted into the bag. Removal of the distal section may create space in the incision/orifice to facilitate withdrawal of the proximal end portions of the bag and cutting elements in a subsequent step of a procedure. Alternatively, the distal section may remain in the incision/orifice, and the proximal end portions of the bag and cutting elements may be withdrawn from the incision/orifice by pulling them around the distal section and sliding them proximally between the distal section and the tissue forming the incision/orifice. Alternatively, the distal section may remain in the incision/orifice, and the proximal end portions of the bag and cutting elements may be withdrawn from the incision/orifice by pulling them through the distal section. A transvaginal approach is described below, and it should be understood that aspects of that approach may be applicable to steps performed using introducers 399a, 399b, 399c, and 399d, and vice-versa.

[00188] Figs. 38-45B illustrate steps for positioning tissue extraction device 300 (or any of the other aforementioned tissue extraction devices) proximate to tissue specimen 308 and performing a procedure on tissue specimen 308. In one example, elongate member 384 of introducer 383 (or the elongate member of any of the other introducers described above), loaded with bag 302 (or any of the aforementioned bags) and cutting elements 304, may be inserted into a subject (Fig. 38). The introduction may be either through an incision or existing bodily orifice 389. After insertion, distal opening 388 may be positioned at a surgical site and/or proximate a tissue specimen (not shown)

[00189] As shown in Fig. 39, actuating pusher 385 may push bag 302 and cutting elements 304 in bag 302 out of distal opening 388 and into the target area. Pusher 385 may push bag 302 and cutting elements 304 (hidden from view in Fig. 39) entirely out of hollow elongate member 384. As bag 302 and cutting elements 304 exit from distal opening 388, cutting elements 304 may move from their collapsed delivery configuration to their expanded deployed configuration.

Additionally or alternatively, stiffening element 328 (not shown in Fig. 40) may move from its collapsed delivery configuration to its expanded deployed configuration (Fig. 40), to open the open end of bag 302 to facilitate insertion of tissue specimen 308 into bag.

[00190] When the user uses any of introducers 399a, 399b, and 399c, the distal sections of each of the introducers may be positioned in, and in some instances secured in, incision/orifice 389. Proximal sections and plungers of each of the introducers may be removed. The body cavity may be insufflated via the distal sections. After insufflation, the distal sections may be capped to maintain the insufflation pressure in the body cavity. Instruments (e.g., forceps, graspers, and/or any other suitable instruments) may be inserted into the body cavity through the caps and distal sections.

[00191 ] Forceps 410 may be used to maneuver tissue specimen 308 into bag 302, or alternatively maneuver bag 302 to surround tissue specimen 308, as illustrated in Fig. 40. Forceps 410 may be used to pull the open end of bag 302 out of the incision or bodily orifice such that the open end is positioned outside of the subject (Fig. 41 ).

[00192] In one example, bag 302 may include splittable sheaths 338' on the interior surface of bag 302. Cutting elements 304 may be removably mounted to the interior surface of bag 302 by channel sheaths 338'. As shown in Fig. 42, proximal portions of cutting elements 304 may be positioned outside the incision or bodily orifice with the open end of bag 302. Cutting elements 304 may be exposed from channel sheaths 338' by, for example, pulling cutting elements 304 away from the interior surface of bag 302 to split channel sheaths 338'.

[00193] Wound retractor 369 may be inserted through the incision or bodily orifice (Figs. 43, 44A, and 44B). Wound retractor 369 may be compressed to fit the distal portion of wound retractor 369 through the incision or bodily orifice. Once inserted, wound retractor 369 may expand to a desired size, and the size may be set by the interaction of engagement members 375 and 376. Securing the size of wound retractor 369 may serve to retract the incision or bodily orifice, and/or stabilize bag 302 relative to the incision or bodily orifice. The freed cutting elements 304 may be inserted through wound retractor 369, and/or wound retractor 369 may be unrolled to receive cutting elements 304 and rolled back into a spiral after receipt. Strands 305 may slide into clips 373 of wound retractor 369, which may serve to secure and/or position cutting elements 304 (Figs. 44A, 44B, 45A, and 45B). The open end bag 302 may be trimmed or pulled back to better expose cutting elements 304.

[00194] Handles 310 may be attached to one or more anchoring ends 306 via hooks 312 (Figs. 44A, 44B, 45A, and 45B). Handles 310 may be shaped to allow a user to easily control, manipulate, and maneuver anchoring ends 306, and thus strands 305. Anchoring element 306 may include a lug or eyelet attached to end of strand 305, a circular loop of strand 305, or any other suitable shape or element that may be removably secured to hook 312 of handle 310.

[00195] Handle 310 may have a T-shaped configuration for gripping by a user (Fig. 48). Alternatively, a handle may be used that may include a D-shaped loop 31 1 (Fig. 49), or a flat handle or tab 313 that may snap onto anchoring element 306 (Figs. 47A and 47B). Handle 313 may include, for example, a slot 315 for slidably receiving anchoring element 306, which may help reduce twisting of strand 305 during pulling.

[00196] Handle 310 may have a switch 413 to open and close hook 312. Handle 31 1 may include a bent clip-hook 317 (Fig. 49). The aforementioned handles may include any another element that may couple to anchoring element 306.

[00197] In one example, two handles 310 may be attached to anchoring ends 306 at the opposite ends of one cutting element 304, with cutting element 304 looping around tissue specimen 308 (Figs. 44A, 44B, 45A, and 45B). One cutting element 304 may be removed from clips 373 in wound retractor 369, while other cutting elements 304 may remain in clips 373 and secured to wound retractor 369 (Figs. 45A and 45B). Handles 310 may be used to move cutting elements 304 to cut tissue specimen 308. For example, cutting may be achieved via proximally pulling on handles 310 in an alternating manner, thus imparting a sawing motion to strand 305, and causing strand 305 to cut tissue specimen 308 (Fig. 45B). During sawing, one end of cutting element 304 may move proximally while the other end of the cutting element 304 may move distally. This movement may be reversed and repeated to cause the cutting element 304 to move back-and-forth about and against tissue specimen 308. The exertion of a proximally-directed force on tissue specimen 308 by cutting element 304 may compress a portion of tissue specimen against the distal end of wound retractor 369, thereby increasing the force exerted against tissue specimen 308 by proximal pulling of cutting element 304. It should be understood that both ends of cutting element 304 may be pulled proximally using handles 310 to compress tissue specimen 308 against wound retractor 369 before and/or during sawing. The proximal pulling may facilitate movement of cutting element 304 further through tissue specimen 308 after each cut into tissue specimen 308, such that a point on strand 305 may follow a zig-zag path through tissue specimen 308.

[00198] The sawing motion may be repeated with other cutting elements 304. This may be accomplished by removing handles 310 from the first cutting element 304, hooking handles 310 onto a different cutting element 304, releasing cutting element 304 from its clip 364, and sawing tissue specimen 308. In one example, the first cutting element 304 may saw completely through tissue specimen 308, and may be removed from bag 302 before another cutting element 304 is used to saw tissue specimen 308. In another example, the first cutting element 304 may be used to saw partially through tissue specimen 308, sawing with first cutting element 304 may cease, a second cutting element 304 may be used to saw tissue specimen 308 until second cutting element 304 approaches or reaches the depth of the first cutting element 304, and so on for any other cutting elements 304. The process may then be repeated to cut deeper into tissue specimen 308, and repeated again until all cutting elements 304 have cut through tissue specimen 308.

[00199] Cutting elements 304 may be moved one at a time, or two or more cutting elements 304 may be moved simultaneously. Cutting elements 304 may be color coded, or identified in some other way, to specify an order of use and/or removal. Because the U-shaped portions of cutting elements 304 may overlap at the closed end 326 of bag 302, a user may use and/or remove the cutting elements 304 in a certain order, for example, with the proximalmost cutting element 304 being used and/or removed first. This process may be repeated until the tissue specimen 308 is cut into small enough pieces that bag 302 containing the tissue specimen 308 may be removed from the incision or bodily orifice. Additionally or alternatively, a user also may remove fragments of tissue specimen 308 from bag 302 using a grasper, forceps, or other retrieval device. The wound retractor 369 may be removed, and the entire bag 302 and its contents may be removed from the incision or orifice, ensuring that the tissue specimen 308 does not escape the bag 302. It is also contemplated that the sawing motion may be performed by attaching anchoring ends 306 of cutting elements 304 to a motor or other powered actuator (not shown) instead of manually-operated handles 310. For example, anchoring ends 306 may be attached to handle assembly 222.

[00200] Steps similar to those described above may be employed when using the other aforementioned bags. Additional or alternative steps also are contemplated. For example, with double-layered bag 342', a user may inflate gap 348 between outer layer 344' and inner layer 346' via insufflation valve 350 and tube 352 prior to sawing. As another example, Figs. 46A-46G illustrate steps for positioning bag 354 proximate to tissue specimen 308 and performing a procedure on tissue specimen 308. A user may deploy bag 354 into a subject's body cavity, via an incision or orifice 389, using any of the aforementioned introducers. Once bag 354 has been deployed, the user may insert tissue specimen 308 into bag 354 (Fig. 46A). Using an instrument 351 , such as a forceps or grasper, the user may pull a proximal end portion of bag 354 out of the incision/orifice 389 (Figs. 46B-46D). For example, the user may grasp bag 354 at outer rim 356 and inner rim 359 using instrument 351 , and pull instrument 351 proximally. Additionally or alternatively, the user may pull bag 354 by grasping gripping members 362 and strands 364 and pulling them proximally. The user may separate inner layer 358 from outer layer 355, and may pull inner layer 358 proximally such that inner body 360 firmly secures (e.g., exerts a compressive force on) tissue specimen 308 (Figs. 46D and 46E). Inner body 360 also may be in tension due to the exerted forces.

[00201 ] The user may free cutting elements 304 from splittable members 365 (Fig. 46E), and may slide a wound retractor 349 over cutting elements 304 (Fig. 46F) and into incision/orifice 389 (Fig. 46G), such that wound retractor 349 may provide a barrier between cutting elements 304 and inner layer 358. Wound retractor 349 may be similar to wound retractor 369 and/or wound retractor 379. Wound retractor 349 may be expanded such that wound retractor 349 may be firmly seated in incision/orifice 389. At its proximal end, wound retractor 349 may include one or more hooks 345. Hooks 345 may engage the mesh or netting forming inner layer 358. The user may pull inner layer 358 proximally to cause inner layer 358 to forcefully engage tissue specimen 308. The force of engagement may be enhanced as tissue specimen 308 is compressed against the distal portion of wound retractor 349 by inner layer 358. The user may secure hooks 345 to inner layer 358, thereby stabilizing inner layer 358 relative to wound retractor 349 and incision/orifice 389, and maintaining the forceful engagement of inner layer 358 and/or wound retractor 349 with tissue specimen 308 (Fig. 46G). The forceful engagement of tissue specimen 308 may facilitate cutting of tissue specimen 308 by, for example, reducing or eliminating movement of tissue specimen 308 as it is being cut by cutting elements 304. It is also contemplated that inner layer 358 may be released from one or more of hooks 345, inner layer 358 may be pulled proximally to increase the force of engagement between inner layer 358 and tissue specimen 308, and inner layer 358 may be secured to one or more of hooks 345 to maintain the enhanced engagement.

[00202] As an alternative, inner layer 358 and cutting elements 304 may be inserted through wound retractor 349, and wound retractor may be seated within incision/orifice 389 between inner layer 358 and outer layer 355. In such an example, inner layer 358 still may be secured to hooks 345 for tightening inner layer 358 about tissue specimen 308.

[00203] As yet another example, Figs. 46H-46W illustrate steps for positioning any of the aforementioned bags and cutting elements in a subject's body cavity, e.g., within the abdomen, by introducing the bag(s) and cutting element(s) into the body cavity via an elongate body orifice of the subject, e.g., via the vagina. In one example bag 354 and cutting elements 304 may be inserted into an introducer 399d, and may be held in a collapsed, delivery configuration by introducer 399d (Fig. 46H). Introducer 399d may be similar to the aforementioned introducers. Introducer 399d may include a tubular elongate member 401 d. A distal end of tubular elongate member 401 d may be blunt or flat to reduce the likelihood of a user accidentally damaging tissue during use of introducer 399d, or may be pointed or sharp to pierce tissue.

[00204] In use, tubular elongate member 401 d may be inserted into the vagina, and through a wound opening 435 formed in the vaginal cuff 437 (at a top of the vagina). Bag 354 and cutting elements 304 may be deployed into the abdomen after being pushed through tubular elongate member 401 d by a pusher 409d (similar to any of the aforementioned pushers) (Fig. 46K), and/or being pulled through by a gasper 439 (Fig. 46J). A camera 441 may be inserted into the abdomen through the incision to provide visualization of the interior of the abdomen.

[00205] Tubular elongate member 401 d may include a securing member 425d. Securing member 425d may include a toroidal member at a distal portion of tubular elongate member 401 d. Securing member 425d may be positioned just distal to the vaginal cuff 437. Securing member 425d may engage the vaginal cuff 437 to secure tubular elongate member 401 d in position within the vagina (e.g., to prevent unintended withdrawal of tubular elongate member 401 d from the vagina during cutting of tissue specimen 308), and/or to maintain pneumoperitoneum in the abdomen after insufflating the abdomen (which may be carried out via tubular elongate member 401 d).

[00206] In one example, securing member 425d may be inflatable, similar to a balloon. Securing member 425d may be inserted into the vagina in a deflated state (Fig. 46H). Securing member 425d then may be inflated to expand at the vaginal cuff 437 (Fig. 46I), by introducing an inflation fluid into securing member 425d via a valve and lumen assembly 443 extending along or through tubular elongate member 401 d. Securing member 425d may be deflated to facilitate removal of tubular elongate member 401 d from the vagina.

[00207] In one example, after being deployed, bag 354 and cutting elements 304 may be drawn around and onto the outer surface of tubular elongate member 401 d. Alternatively, tubular elongate member 401 d may be withdrawn from the vagina after deploying bag 354 and cutting elements 304 in the abdomen, proximal ends of bag 354 and cutting elements 304 may be extracted through the vagina after tissue specimen 308 has been inserted into the bag 354, and tubular elongate member 401 d may be inserted back into the vagina. Tubular elongate member 401 d, like the aforementioned wound retractors, may surround the cutting elements and form a protective barrier between cutting elements 304 and bag 354, thereby protecting bag 354 and/or vaginal tissue during cutting. Tubular elongate member 401 d may include one or more hooks (not shown), similar to hooks 345, for securing inner layer 358 to tubular elongate member 401 d.

[00208] Alternatively, tubular elongate member 401 d may remain in the vagina after deployment of bag 354 and cutting elements 304. In such an example, securing member 425d may be inflated at the vaginal cuff any time before, during, or after deployment of bag 354 and cutting elements 304. Once deployed, bag 354 and cutting elements 304 may move to an expanded configuration (Fig. 46L). A cap 421 d, similar to any of the aforementioned caps, may be applied onto tubular elongate member 401 d to maintain insufflation pressure in the abdomen (Fig. 46M). Tissue specimen 308 may be inserted into bag 354 using graspers 439 and 445. Camera 441 may be positioned through an incision in the abdomen (Fig. 46N) or through cap 421 d and tubular elongate member 401 d (Fig. 460), to provide visualization during insertion of tissue into bag 354.

[00209] After tissue specimen 308 is inserted into bag 354, cap 421 d may be removed (Fig. 46P), and proximal ends of bag 354 and cutting elements 304 may be extracted from the abdomen and vagina through the interior of tubular elongate member 401 d (Fig. 46Q). Inner layer 358 and outer layer 355 may be separated, and the proximal end portion of inner layer 358 may be pulled outwardly from the vagina to tighten inner layer 358 around tissue specimen 308 (Fig. 46R). Inner layer 358 may be secured to hooks (not shown) on a proximal end of tubular elongate member 401 d, the hooks being similar to hooks 345 of wound retractor 349. Cutting elements 304 may be disengaged/exposed from inner layer 358 (Fig. 46S) and used to cut tissue specimen 308 with the aforementioned sawing motion (Fig. 46T). Tubular elongate member 401 d may form a protective barrier between bag 354 and cutting elements 304, and the vaginal tissue.

[00210] Cutting elements 304 may be extracted after being used. Cut pieces of tissue specimen 308 may be extracted via tubular elongate member 401 d (Fig. 46U). Once all of the cut pieces have been extracted, bag 354 and tubular elongate member 401 d may be extracted (Fig. 46V). Securing member 425d may be deflated to facilitate extraction of tubular elongate member 401 d. Finally, wound opening 437 at the vaginal cuff may be surgically closed.

[0021 1 ] In any of the foregoing examples, the strands of the cutting elements may have blades or other cutting members disposed thereon. The blades or cutting members may be disposed on the strands such that they extend away from the interior surface of the bag (e.g., toward the tissue specimen during performance of a procedure). The side from which the blades or cutting members extend may be referred to as a cutting side of the cutting element. Opposite the cutting side, the cutting element may include a smooth side that may face or abut the interior surface of the bag. Having the blades or cutting members along the cutting side and not smooth side may reduce the likelihood that the blades or cutting members may damage the bag during insertion of the bag and the cutting elements into the target area, and/or during cutting of the tissue specimen.

[00212] The blade or cutting members may be disposed along the entire length of the strand, or may only be disposed on an effective cutting length of the strand. The effective cutting length may include a portion of the strand proximate the closed end of the bag. For example, the effective cutting length may extend along the base of a U-shaped strand, and at least partially up the legs of the U-shaped strand.

[00213] In one example, shown in Figs. 50A-50E, a cutting element 400 may include a linear array of partially helical cutting members 402. Cutting member 402 may include a curved cutting edge 404. Curved cutting edges 404 may be disposed on only one side (e.g., a cutting side) of a strand 406. Cutting members 402 may be integral with strand 406 or may be assembled onto or inserted into strand 406. In another example shown in Figs. 51 A-51 G, partially helical cutting members 402' may have straight cutting edges 404'. In yet another example shown in Figs. 52A-52F, partially helical cutting members 402" may alternate in direction along the effective cutting length of strand 406, forming a zig-zag pattern. Strand 406 may include a wire-like member or braided filaments similar to filaments 192 of strand 182.

[00214] In another example shown in Figs. 53A-53F, a cutting element 408 may include a strand 410 and a cutting saw 412 with a linear array of cutting teeth 414. Teeth 414 may have sharp points, and concave or indented regions 416 may lie between the sharp points. Cutting saw 412 may have varying distances between teeth 414, as well as varying heights or widths of teeth 414. Cutting saw 412 also may have a smooth portion 418 beside its effective cutting length. Smooth portion 418 may allow for a smooth entry of tissue specimen 308 onto the effective cutting length, thereby reducing the initial force needed to move the effective cutting length across tissue specimen 308. Cutting saw 412 may be integral with strand 408, or may be mounted on or attached to strand 408. Cutting saw 412 may have a triangular cross-sectional profile (Fig. 53G). [00215] In another example shown in Figs. 54A-54H, a cutting element 420 may include a strand 422 having a zig-zag, staggered cutting pattern of teeth 424 over its effective cutting length, and a smooth entry section 426. Teeth 424 may be arranged in two parallel rows extending longitudinally along strand 422, with teeth 424 in one row being positioned beside gaps between teeth 424 of the other row. While identical teeth 424 are depicted, it is contemplated that teeth 424 may have different orientations (e.g., may lie at different angles relative to the surface of strand 422) and/or profiles. Teeth 424 may be integral with strand 422 or may be mounted or attached to strand 422.

[00216] As shown in Figs. 55A and 55B, a cutting element 428 may feature a cutting blade 430. Cutting blade 430 may have a half-moon or semicircular shape, defining a cutting edge 432, with an arc that extends longitudinally along and radially away from a strand 433. Cutting blade 430 may be integral with strand 433 or securely connected to strand 433. For example, as shown in Figs. 56A and 56B, a cutting element 428', similar to cutting element 428, may include a cutting blade 430' attached to a strand 433' by a securing joint 434. Securing joint 434 may be formed by welding, brazing, and/or any other suitable form of attachment. Strand 433 and/or strand 433' may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00217] As shown in Figs. 57A and 57B, a cutting element 436 may include a strand 438 having a cutting blade 440 thereon. Cutting blade 440 may have a triangular shape, and may include a first cutting edge 442 and a second cutting edge 444 that meet at a point 446. Cutting blade 440 may be integral with strand 438. In another example shown in Figs. 58A-58C, a cutting element 436', similar to cutting element 436, may include a cutting blade 440' with cutting edges 442' and 444' and a point 446'. Cutting blade 440' may be attached to a strand 438' by a securing joint 448. Strand 438 and/or strand 438' may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00218] In a further variation, a cutting element 450 may include a strand 452, a tubular holding element 454 surrounding strand 452, and a cutting blade 454 attached to a tubular holding element 455 (Figs. 59A-59D). Cutting blade 454 may include a first triangular blade 456, and a second triangular blade 458 on top of and secured to first triangular blade 456. First triangular blade 456 and second triangular blade 458 may be offset to define first and second cutting edges 460 and 462. A securing joint 464 may secure first and second triangular blades 456 and 458, and may secure cutting blades 456 and 458 to tubular holding element 454. It is contemplated that strand 452 may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00219] In another example shown in Figs. 60A-60C, a cutting element 450', similar to cutting element 450, may include a single triangular cutting blade 464 with two cutting edges 460' and 462'. Cutting blade 464 may be mounted on a tubular holding element 455' that may surround strand 452. In another example shown in Figs. 61 A-61 C, a cutting element 450", similar to cutting element 450', may include a cutting blade 464" having cutting edges 460" and 462", with cutting blade 464" being formed with an integral tubular portion 455". Tubular portion 455" may be securely coupled to strand 452, and may extend over and at least partially surround strand 452.

[00220] In another example, a cutting element 474 may include cutting beads 476 mounted on strand 452 (Figs. 62A-62H). Cutting beads 476 may have a hollow annular cross-section, such that they may be slid onto strand 452. When a plurality of cutting beads 476 are mounted on strand 452 to form an effective cutting length, adjacent beads 476 may be joined by rotatable joints. An exemplary rotatable joint may include one or more rounded protrusions 478 of one bead 476 movably received in one or more rounded recesses 480 of an adjacent beads 476. This may allow beads 476 to rotate or pivot relative to each other to accommodate bending of strand 452. Each cutting bead 476 also may have a partially helical cutting edge 482. Cutting edges 482 of adjacent cutting beads 476 may be aligned along the cutting side of the effective cutting length of cutting element 474. In another example shown in Figs. 63A-63F, cutting beads 483 may include pairs of diametrically-opposed cutting edges 484a, 484b, 486a, and 486b. Cutting edges 484a and 484b may be offset by 90 degrees from cutting edges 486a and 486b.

[00221 ] In another example shown in Figs. 64A-64G, a cutting element 488 may include at least one blade 490 secured between two strands 494 and 496. Blade 490 may have a width that tapers going toward a cutting edge 498. For example, in a section or end view, blade 461 may have a base 500 with a constant width, and a triangular tip 502 (Fig. 64E). Additionally or alternatively, blade 461 may have a trapezoidal shape. Alternatively, a strand (not shown) may include one or more slots or grooves along its length for receiving one or more blades 490.

Blade 490 may be brazed, welded, or otherwise attached to the strand or strands 494 and 496.

[00222] In another example, a cutting element 504 may include a strand 506 having a triangular cross-sectional shape terminating on one side with a cutting edge 508, and terminating on the other side with a flat surface 510 (Figs. 65A and 65B). Cutting element 504 also may include cutouts 512 on a cutting side to allow tissue to enter cutouts 472, thereby positioning the tissue for cutting by cutting edges 508 when strand 466 is moved, as well as to ensure that cutting edges 508 do not interfere with each other even when cutting element 504 is bent. It is contemplated that strand 506 may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00223] In a further example, a cutting element 514 may include a strand 516, and a tissue cutting or abrading tube 518 surrounding strand 516 (Figs. 66A- 66E). Tube 518 may have a cross-sectional shape corresponding to a cross- sectional shape of strand 516. For example, when strand 516 has a triangular cross- sectional shape, tube 518 also may have a triangular cross-sectional shape. Tube 518 may include one or more edged apertures 520 to form a cutting and/or abrasive side. Apertures 520 may be circular or another suitable shape. It is contemplated that strand 516 may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00224] In another example shown in Figs. 67A-67F, multiple cutting tubes 522 may surround a strand 524. Tubes 522 may have a body 526, and a blade 528 extending from body 526. Blade 528 may have an arced or curved cutting edge 530. A plurality of tubes 522 may be positioned along strand 524 and may be spaced apart such that strand 524 may bend without tubes 522 interfering with each other. Body 526 may have a rectangular cross-sectional shape when strand 524 has a similar shape, or may have any other suitable cross-sectional shape depending on the cross-sectional shape of strand 524. For example, a body 526' of a tube 522' may have a triangular cross-sectional shape to match a strand 524' having a similar cross-sectional shape. In another example, a tube 532 may include staggered teeth 534 and 536, which may be curved, triangular, pyramidal, or any other suitable shape (Figs. 69A-69E). It is contemplated that strand 524 may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B).

[00225] In another example shown in Figs. 70A-70E, a tube 538 may include a through-hole 540 for receiving a strand. The cross-sectional shape of through-hole 540 may match the cross-sectional shape of the strand. It is

contemplated that the strand may include a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B). Tube 538 may have teeth 542 similar to teeth 414 (Figs. 53A-53G).

[00226] In a further example shown in Figs. 71 A-71 E, a tube 544 may include a cylindrical core or body 546 with a through-hole 548, and a blade 550 having a cutting edge 552. Cutting edge 552 may be toothed/serrated. Blade 550 may be angled across core 546. For example, blade 550 may be partially helical. Tube 544 may have a smooth entry chamfer 552 at one end or both ends. It is contemplated that a strand, formed of a wire-like member or braided filaments similar to filaments 192 of strand 182 (Fig. 16B), may be received in through-hole 548.

[00227] In the aforementioned examples the tubes may be coupled to strands through welding, brazing, adhesive attachment, and/or other suitable coupling methods. Also in the aforementioned examples, the strands may have a non-circular cross-sectional shapes for a number of reasons. For example, the use of non-circular cross-sectional shapes may reduce the likelihood of the strands rotating or twisting when in use. Additionally or alternatively, the use of non-circular cross-sectional shapes may facilitate bending of the strands in one or more directions and/or discourage bending of the strands in one or more directions.

Additionally or alternatively, using non-circular cross-sectional shapes may help maintain the cutting sides of the cutting elements pointed away from the interior surface of the bag, and/or maintain the smooth sides of the cutting elements pointed toward the interior surface of the bag. The aforementioned tubes may have corresponding cross-sectional shapes so they are securely mounted on their strands. It is also contemplated that a single tube may be provided on a single strand, or a plurality of tubes may be provided on a single strand. The plurality of tubes on the single strand may be of the same type, or may be a combination of any of the aforementioned strands.

[00228] In a further aspect illustrated in Figs. 72A-72E, a cutting element 554 may be at least partially formed of a plurality of saw elements or links 556. Each element link 556 may include a jagged or toothed side 558 (corresponding to the cutting side of cutting element 554) and an opposite smooth side 560. Links 556 may have holes 562 formed thereon. Links 556 may be arranged such that holes 562 of one link 556 may overlap holes 562 of adjacent links 556, allowing adjacent links 556 to be pivotably joined together by rivets 564 inserted through holes 562. A plurality of linked links 556 may form a chain. The chain may be connected at its ends to strands (not shown). The strands may be removably connected to handles, such that the chain may be manipulated from outside of a bag to cut a tissue specimen. Alternatively, the chain may be directly connected to the handles for sawing the tissue specimen.

[00229] As illustrated in Figs. 27 and 73, a cover 566 may be provided to receive any of the aforementioned blade structures and cutting members. The bottom surface of cover 566 may be affixed to an interior surface 567 of a bag.

Cover 566 may include a cavity or slot 568 for slidably receiving the blade structures and cutting members. Cover 566 may extend over the cutting edges of the blade structures and cutting members to keep the cutting edges from contacting other components. For example, when cutting elements are inside an introducer with strands and a bag, cover 566 may keep the cutting edges of any blade structures or cutting members from damaging the bag, each other, and/or the strands.

Additionally or alternatively, covers 566 may aid in positioning the blade structures and cutting members on the interior surface of the bag so as to avoid interference between the blade structures or cutting members. The blade structures and cutting members may be deployed from cover 566 by being slid laterally out of slot 568 (into or out of the page in Fig. 73).

[00230] In any of the aforementioned examples, the strands may be constructed of wires and/or cables. The strands may be made out of steel, Nitinol or any other similar suitable materials. Further, the various blade structures and cutting members discussed in the aforementioned examples may be made of ceramic, stainless steel, titanium, and/or any other suitable material.

[00231 ] It is contemplated that one tissue extraction device may include different types of cutting elements. For example, one tissue extraction device may include cutting elements with different blade structures and/or cutting members. Additionally or alternatively, one cutting element may include different blade structures and/or cutting members. Cutting elements also may include a single type of blade structure and/or cutting member, but with blade structures and/or cutting members varying in dimensions. It is also contemplated that any of the cutting elements described above may be used in any of the tissue extraction devices described above. Also, aspects of any of the cutting elements described above may be used in combination with aspects of any of the other cutting elements described above. [00232] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed devices and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as exemplary only.

Claims

CLAIMS We claim:

1 . A tissue extraction device, comprising:

a bag having an interior;

a cutting element extending through the interior of the bag, wherein the cutting element includes:

a strand, and

a cutting member on the strand, wherein the cutting member includes an edge for cutting tissue as the cutting member is drawn across tissue.

2. The tissue extraction device of claim 1 , wherein the cutting member includes a blade on the strand.

3. The tissue extraction device of claim 1 , wherein the edge is linear.

4. The tissue extraction device of claim 1 , wherein the edge is curved.

5. The tissue extraction device of claim 1 , wherein the edge forms a partial helix.

6. The tissue extraction device of claim 1 , wherein the cutting member is one of a plurality of cutting members on the strand, and the edge is one of a plurality of edges of the plurality of cutting members.

7. The tissue extraction device of claim 6, wherein each edge of the plurality of edges is discrete, separated from all other edges of the plurality of edges by a gap.

8. The tissue extraction device of claim 1 , further including a member coupled to an interior surface of the bag, such that a channel is defined between the member and the interior surface, wherein the cutting element extends through the channel.

9. The tissue extraction device of claim 1 , wherein the cutting element includes eyelets.

10. The tissue extraction device of claim 9, further including handles, wherein the handles are removably coupled to the eyelets.

1 1 . The tissue extraction device of claim 1 , further including a wound retractor surrounding the cutting element.

12. The tissue extraction device of claim 1 1 , wherein the wound retractor includes a clip that removably receives a portion of the cutting element.

13. The tissue extraction device of claim 1 1 , wherein the wound retractor has a spiral shape.

14. The tissue extraction device of claim 1 , wherein the bag includes an inner layer and an outer layer.

15. The tissue extraction device of claim 14, wherein the inner layer includes a mesh.

16. The tissue extraction device of claim 15, further including a wound retractor surrounding the cutting element, the wound retractor include a hook for engaging the mesh.

17. The tissue extraction device of claim 14, wherein a rim of the inner layer is removably coupled to a rim of the outer layer.

18. A method of extracting a tissue specimen from a subject with a tissue extraction device having a bag and a cutting element, the method comprising: inserting the bag and the cutting element together through an opening in the subject;

inserting the tissue specimen into the bag;

extracting a proximal portion of the bag, and ends of the cutting element, from the subject, via the opening;

holding the ends of the cutting element; and

cutting the tissue specimen with the cutting element by moving the cutting element back-and-forth in a sawing motion across the tissue specimen.

19. The method of claim 18, further including inserting a wound retractor into the bag and positioning the wound retractor in the opening.

20. The method of claim 19, further including removably securing the cutting element to the wound retractor.

21 . The method of claim 19, further including retracting the opening by expansion of the wound retractor.

22. The method of claim 19, further including compressing the tissue specimen between the cutting element and an end of the wound retractor.

23. The method of claim 19, further including securing the bag to the wound retractor.

24. The method of claim 23, wherein securing the bag to the wound retractor includes hooking the bag onto the wound retractor.

25. The method of claim 18, wherein the bag includes an inner layer and an outer layer, and the method further includes separating the inner layer from the outer layer to tighten the inner layer around the tissue specimen.

26. The method of claim 25, wherein separating the inner layer from the outer layer includes breaking a separable connection that removably couples the inner layer to the outer layer.

27. The method of claim 18, wherein cutting the tissue specimen includes moving a cutting member on the cutting element back-and-forth across the tissue specimen.

28. The method of claim 27, wherein cutting the tissue specimen includes moving an edge of the cutting member back-and-forth across the tissue specimen.

29. The method of claim 18, wherein inserting the bag and the cutting element through the opening includes penetrating the opening with an introducer, and deploying the bag and the cutting element from the introducer.

30. The method of claim 29, wherein the cutting element moves from a collapsed configuration to an expanded configuration when the cutting element is deployed from the introducer, and the cutting element moves the bag from a collapsed configuration to an expanded configuration when the bag is deployed from the introducer.

31 . The method of claim 29, wherein the introducer includes a tubular elongate member for receiving the bag and the cutting element.

32. The method of claim 31 , wherein the introducer further includes an inflatable securing member for securing the tubular elongate member in the opening.

33. The method of claim 31 , wherein the tubular elongate member includes a proximal section and a distal section, the proximal section and the distal section are removably coupled, the proximal section is uncoupled from the distal section and removed from the subject after the bag and the cutting element are deployed from the introducer, and the distal section remains in the opening as the tissue specimen is inserted into the bag.

34. A method of extracting a tissue specimen from a subject with a tissue extraction device having a bag and a cutting element, the method comprising: inserting the bag and the cutting element together through an opening in the subject;

inserting the tissue specimen into the bag;

separating an inner layer of the bag from an outer layer of the bag;

moving the inner layer of the bag relative to the outer layer of the bag to tighten the inner layer of the bag around the tissue specimen; and

cutting the tissue specimen with the cutting element.

35. The method of claim 34, further including inserting a wound retractor into the opening.

36. The method of claim 35, further including securing the inner layer of the bag to the wound retractor to maintain a tightness of the inner layer of the bag around the tissue specimen.

37. The method of claim 34, further including compressing the tissue specimen between the inner layer of the bag and an end of the wound retractor.

38. The method of claim 34, further including compressing the tissue specimen between the cutting element and an end of the wound retractor.

39. The method of claim 36, wherein securing the inner layer of the bag to the wound retractor includes bringing the inner layer into engagement with one or more hooks on the wound retractor.

40. The method of claim 39, wherein bringing the inner layer of the bag into engagement with the one or more hooks includes sliding the one or more hooks in a radial direction relative to a proximal-facing surface of the wound retractor.

41 . The method of claim 35, further including inflating a portion of the wound retractor to secure the wound retractor in the opening.

42. The method of claim 34, further including adjusting a width of a wound- engaging portion of the wound retractor to retract the opening.

43. The method of claim 42, wherein adjusting a width of the wound engaging portion includes moving discrete sections of the wound engaging portion apart from each other.

44. A tissue extraction device, comprising: a bag having an interior;

a strand extending through the interior of the bag, wherein the strand includes a plurality of braided filaments, the braided filaments defining a series of protrusions and recesses for abrading tissue when pulled across the tissue.