Tissue extraction system and method

Abstract

A system and method are provided for preventing the seeding of cancerous cells during the morselization of a tissue sample within a patient's body and the removal of the tissue sample from the patient's body through a minimally invasive body orifice to the outside of the patient's body. The system includes a cut-resistant tissue guard (28) removably insertable into a containment bag (18). The tissue specimen is isolated and contained within the containment bag, and the guard (28) is configured to protect the containment bag and surrounding tissue from accidental contact with sharp instruments used during morselization and extraction of the tissue specimen. The guard (28) is adjustable to allow for easy insertion and removal, and is configured to securely anchor within the body orifice (14). A containment-based system for tissue removal is provided that focuses on protection and enables minimally invasive procedures to be performed safely and efficiently.

Description

Technical Field

[0001] The present invention relates to medical devices, particularly systems and methods for the extraction or removal of tissue through body openings.

[0002] [Description of Related Applications] This application claims priority and the benefit of U.S. Provisional Patent Application No. 61 / 982,997, filed on April 23, 2014 (invention name: Tissue morcellator), U.S. Provisional Patent Application No. 61 / 983,413, filed on April 23, 2014 (invention name: Systems and methods for tissue removal through small incision sites), U.S. Provisional Patent Application No. 62 / 014,038, filed on June 18, 2014 (invention name: Systems and methods for tissue removal through small incision sites), U.S. Provisional Patent Application No. 62 / 024,698, filed on July 15, 2014 (invention name: Systems and methods for tissue removal through small incision sites), U.S. Provisional Patent Application No. 62 / 079,171, filed on November 13, 2014 (invention name: Systems and methods for tissue removal), U.S. Provisional Patent Application No. 62 / 081,297, filed on November 18, 2014 (invention name: Systems and methods for tissue removal), and U.S. Provisional Patent Application No. 62 / 107, for tissue removal) and U.S. Provisional Patent Application No. 62 / 107,107, filed on January 23, 2015 (invention name: Cut-resistant retracting tissue bag). All of these U.S. provisional patent applications are hereby incorporated by reference in their entirety and made a part of the specification herein.

Background Art

[0003] Systems and methods for the surgical removal of tissue through small incision sites and / or body openings, including various body orifices, are described in the literature. Where necessary, a small incision is made in the patient to access the surgically targeted tissue located within a body cavity. The surgically targeted tissue can also be accessed through a body orifice without an initial incision. In some cases, the target tissue is accessed directly through an incision or body orifice. In some cases, an access instrument system is positioned and placed in and / or across the incision and / or body orifice to retract, enlarge, reshape and / or isolate the tissue. The access instrument system acts as a gateway or portal for accessing the target tissue located within or adjacent to a body cavity or body orifice. The target tissue is separated from adjacent and surrounding tissue by employing known surgical techniques or procedures. Once freed, the target tissue is readily accessible through a small incision or body orifice. If the target tissue is too large to be removed as a whole, its size is reduced and it is partially removed through a small incision. Ideally, the surgeon "cores" or "peels off" the surface of the target tissue to keep it as intact as possible. However, in more than 50% of cases, the target tissue ends up in numerous small pieces.

[0004] Reducing the size of a target tissue is called slicing. In slicing, the target tissue is cut into small pieces using a knife or electric slicer, and the tissue is then removed through a small incision. The small pieces of target tissue are removed from the patient through a small incision. When reducing the size of the target tissue so that it can pass through a small incision, some pieces of tissue may be cut off and left in the patient's body. Therefore, slicing is contraindicated in cases of malignant tumors or endometriosis. When cancer is sliced, the cancer may spread malignant tissue and advance the stage of the cancer, and may increase the patient's mortality rate.

[0005] Hysterectomy is an example of a surgical procedure that may involve dissection. More than 500,000 hysterectomies are performed annually on women in the United States. Common reasons for a woman to undergo a hysterectomy include the presence of fibroid, cancer, endometriosis, or uterine prolapse. Approximately 200,000 of these hysterectomies are performed laparoscopically. If the uterus is too large (over 300g) to be removed through the vagina, or if the cervix remains in place, the size of the specimen must be reduced in order to remove it through an abdominal incision or vaginally. During myomectomy (fibroid removal), it may be necessary to remove large fibroids using dissection techniques. During dissection, the target tissue (usually the uterus and sometimes adnexal structures) is brought to the surface of the abdominal wall, for example, using a tissue gripper, and its size is reduced using a blade before being removed through the incision into the pelvic cavity. Alternatively, the target tissue is removed through a body opening, such as the vagina. Fibroids or leiomyomas account for approximately 30–40% of hysterectomies. These are benign tumors of the uterus, and they can cause heavy and painful bleeding. In the past, it was thought that these tumors could be missed cancers or leiomyomas, affecting about 1 in 10,000 women. More recent data confirms an extremely high risk of missed malignancies among these tumors, estimated at 1 in 1,000–1 in 400. Because the risk is so high, many surgeons have begun to modify their techniques to perform a closed shredding process, enclosing the specimen in a bag to contain the loose fragments and prevent the spread and seeding of tumor cells, rather than shredding without a bag in a process called open shredding. Many GYN societies, including AAGL, ACOG, and SGO, have issued statements warning of the potential dangers of open shredding. On April 17, 2014, the FDA issued a statement advising against the use of open motorized shredding for hysterectomies and fibroid resections in women undergoing these procedures for fibroids. The FDA also increased the estimated likelihood of malignancy to 1 in 350.For these reasons, there is a need for systems and methods for safely and effectively reducing tissue samples. The present invention relates to such safe systems and methods for both manual and motorized shredding performed in a closed system. [Overview of the project]

[0006] According to one aspect of the present invention, a tissue shredding system is provided for preventing the dissemination of cancer cells during the shredding of a tissue sample inside a patient's body and during the removal of the tissue sample from the patient's body to the outside of the patient's body through a minimally invasive body opening. The system includes a containment bag, which has an interior and an opening for accessing the interior of the containment bag. The opening has a perimeter, and the containment bag is sized and shaped to receive a tissue sample inside. The containment bag is configured to be inserted and removed through a body opening. The system further includes a tissue guard made of a cut-resistant material, which has a proximal end and a distal end connected to each other by side walls. The guard has an inner surface, an outer surface, and a working channel extending from the proximal end to the distal end along the longitudinal axis. The tissue guard is removablely insertable into the containment bag, and the tissue guard is configured to protect the containment bag during the shredding and removal of the tissue sample.

[0007] According to another aspect of the present invention, a system is provided for safely removing a tissue sample through a body opening. The system includes a guard having a band made of a flexible, cut-resistant material. The band has an inner and outer surface connected to one another by an apical end and a basal end, as well as a first end and a second end. The band is configured to define a central lumen along the longitudinal axis. The central lumen has a lumen diameter measured perpendicular to the longitudinal axis. The outer surface of the band has a recess that extends circumferentially around the guard from the first end to the second end, along at least a portion of the longitudinal axis from the apical end to the basal end. At least a portion of the outer surface of the band overlaps with and is oriented toward at least a portion of the inner surface of the band such that the inner surface of a portion of the band fits into the recess of the outer surface of the band.

[0008] According to another aspect of the present invention, a system is provided for removing a tissue specimen through a body opening. The system includes a containment bag having side walls that define the interior. The containment bag has a first end and a second end. The bag further has a bag opening located at the first end, which is connected to and leads into the interior of the bag. The bag opening is sized and shaped to receive a tissue specimen. The system further includes a protective guard that circumferentially surrounds at least a portion of the interior of the containment bag and extends along at least a portion of the interior of the containment bag between the opening and the second end, defining a protected lumen. The protective guard has a proximal end, a distal end and a longitudinal axis, and is configured to prevent penetration of the containment bag. The containment bag and protective guard define a removal path for a tissue specimen placed inside the containment bag. The removal path includes a path through which the tissue passes through the protected lumen and out through the bag opening.

[0009] According to another aspect of the present invention, a system is provided for extracting a tissue sample from a patient's body through a body opening. The system includes a shield having side walls defining a central lumen extending along a longitudinal axis from the apex to the base. The shield has an outer surface, and the central lumen has a lumen diameter. The side walls of the shield are divided to form a first end and a second end. Part of the shield is fitted into another part of the shield. The shield can move between a reduced lateral configuration having a reduced lumen diameter and an enlarged lateral configuration having an enlarged lumen diameter by changing the fitted portion of the shield.

[0010] According to another aspect of the present invention, a system is provided for safely removing a tissue specimen from inside a patient's body to outside the patient's body through a body opening. The body opening defines the tissue margin, and the system includes a containment bag, which has an opening for accessing the interior and the interior of the containment bag. The containment bag is sized and configured to receive a tissue specimen inside the containment bag. The system further includes a shield having side walls made of a cut-resistant material. The side walls define a central working channel extending along a longitudinal axis from the top to the bottom. The shield is adjustable so as to reduce the diameter of the working channel so as to be insertable into the body opening. The shield is removablely insertable into the body opening with a portion of the containment bag crossing the tissue margin, a portion of the containment bag located inside the patient's body, and a portion of the bag with the body opening located outside the patient's body. The shield is adjustable so as to enlarge the working channel by increasing its diameter.

[0011] According to another aspect of the present invention, a system is provided for safely removing a tissue specimen from inside a patient's body to outside the patient's body through a body opening. The body opening defines the tissue margin, and the system includes a containment bag, which has an opening for accessing the interior and the interior of the containment bag. The containment bag has a proximal end and a distal end, and the containment bag is sized and shaped to receive a tissue specimen inside the containment bag. The system further includes a retractor having a first ring and a second ring connected to each other by side walls. The second ring of the retractor is reversibly compressible into a low-profile shape to facilitate insertion through the body opening. The retractor is configured such that the side walls can be rounded around the first ring to reduce the length of the retractor and retract the tissue margin.

[0012] According to another aspect of the present invention, a system is provided for safely removing a tissue specimen from inside a patient's body to outside the patient's body through a body opening. The body opening defines the tissue margin, and the system includes a retractor having a first ring and a second ring connected to each other by flexible sidewalls defining a central lumen with a top opening and a bottom opening. The second ring of the retractor is compressible into a low-profile, elongated form that can be inserted through the body opening. The first ring has a first ring diameter. The retractor is configured so that the sidewalls can be rounded around the first ring to reduce the length of the retractor and retract the tissue margin. The system further includes a shield made of a cut-resistant material having a proximal end and a distal end connected to each other by sidewalls. The shield has an inner surface, an outer surface, and an elongated tubular working channel extending from the proximal end to the distal end along the longitudinal axis. The shield is located at the proximal end and has a proximal flange extending radially outward from the longitudinal axis to define the outer diameter around the proximal end. The shield is dimensioned and shaped to be detachably connected to the retractor when the retractor is positioned across the body opening and the shield is inserted into the central lumen of the retractor.

[0013] According to another aspect of the present invention, a method is provided for safely removing a tissue specimen from inside a patient's body to outside the patient's body through a body opening. The method includes the step of preparing a shield made of a cut-resistant material. The shield has a proximal end and a distal end connected to each other by flexible, semi-rigid side walls. The shield has an inner surface, an outer surface, and an elongated, substantially tubular working channel extending from the proximal end to the distal end along the longitudinal axis, the working channel preferably having curved inner and outer surfaces. The working channel has a lumen diameter, and the body opening defines the tissue margin at the body opening. The method includes the steps of inserting the shield into the body opening and fixing the shield to the body opening.

[0014] According to another aspect of the present invention, a tissue cutting system is provided for removing a tissue specimen from inside a patient's body to outside the patient's body through a body opening. The cutting system includes a cutter having a proximal end, a distal end, and a longitudinal axis. The cutter has a housing located at the proximal end and an outer shaft extending distally from the housing along the longitudinal axis. The outer shaft has a length from the distal end of the housing to the distal end of the cutter. The cutter has an inner shaft coaxial with the outer shaft. The inner shaft has a blade located at the distal end for cutting tissue. The cutter has a working channel extending through the housing and an inner shaft between a proximal opening at the proximal end and a distal opening at the distal end. The inner shaft is configured to rotate and bend toward the outer shaft to cut tissue at the distal blade. The cutting system further includes a tissue guard made of a cut-resistant material having a proximal end and a distal end connected to each other by side walls. The shield has an inner surface, an outer surface, and a central lumen extending from the proximal end to the distal end along the longitudinal axis. The tissue guard is configured to adhere to the tissue margin. The outer shaft of the shredder is removablely insertable into the central lumen of the guard, and the guard is configured to protect the tissue margin from the blade during shredding.

[0015] According to another aspect of the present invention, a system is provided for removing a tissue sample from inside a patient's body to outside the patient's body through a body opening. The system includes a shield made of a cut-resistant material and having side walls defining a central working channel extending along a longitudinal axis from the apex to the base. The system has a blade, which is coupled to the shield so that the blade can move relative to the shield along a predetermined path. The predetermined path is configured such that the blade moves along at least a portion of the working channel. The system is configured such that, during shredding, the movement of the blade relative to the shield cuts the tissue and the tissue is drawn into the working channel.

[0016] According to another aspect of the present invention, a system is provided for preventing the dissemination of cancer cells during the shredding of a tissue sample inside a patient's body and the removal of the tissue sample from the patient's body to the outside of the patient's body through a minimally invasive body opening. The system has a containment bag with an interior and a bag opening. The containment bag is configured to isolate and contain a tissue sample. The system further includes a cut-resistant tissue guard that is removablely insertable into the containment bag. The guard is configured to protect the containment bag and surrounding tissue from accidental contact with sharp instruments used during the shredding and removal of the tissue sample. [Brief explanation of the drawing]

[0017] [Figure 1] This is a cross-sectional view of a storage bag and guard arranged in an opening in the body wall according to the present invention. [Figure 2] This is a perspective view of the guard according to the present invention, seen from above. [Figure 3] This is a side view of the guard according to the present invention. [Figure 4] This is an end view of the guard according to the present invention. [Figure 5] This is a cross-sectional view of the guard according to the present invention, taken along the line 5-5 in Figure 4. [Figure 6] This is a cross-sectional view of the guard according to the present invention, taken along the line 6-6 in Figure 4. [Figure 7] This is a perspective view of the guard according to the present invention, seen from above. [Figure 8] This is a side view of the guard according to the present invention. [Figure 9] This is an end view of the guard according to the present invention. [Figure 10] This is a cross-sectional view of the guard according to the present invention, taken along the line 10-10 in Figure 9. [Figure 11] This is a top-down perspective view of the cap according to the present invention. [Figure 12] This is a cross-sectional side view of the cap and guard according to the present invention. [Figure 13] This is a side view of the cap and guard according to the present invention. [Figure 14]Perspective view of the cap and guard according to the present invention, seen from above. [Figure 15] Perspective view of the guard according to the present invention, seen from above. [Figure 16] Perspective view of the guard according to the present invention, seen from above. [Figure 17] Cross-sectional side view of the guard according to the present invention. [Figure 18] Perspective view of the retractor according to the present invention, seen from above. [Figure 19] Perspective view of the retractor according to the present invention, seen from above. [Figure 20A] Perspective view of the combination of the storage bag and the retractor according to the present invention, seen from above. [Figure 20B] Cross-sectional side view of the storage bag provided with the tissue specimen, body wall and two rings according to the present invention. [Figure 21] Perspective view of the storage bag in the expanded state according to the present invention, seen from above. [Figure 22] Perspective view of the storage bag in the partially collapsed state according to the present invention, seen from above. [Figure 23] Perspective view of the storage bag in the twisted state according to the present invention, seen from above. [Figure 24] Plan view of the storage bag in the twisted state according to the present invention. [Figure 25A] Perspective view of the two-piece molded guard in the unassembled state according to the present invention, seen from above. <0​​​​​​​​​​​​​​This is a top-down perspective view of a balloon trocar equipped with a removable seal housing according to the present invention. [Figure 31] This is a cross-sectional side view of the balloon trocar according to the present invention. [Figure 32] This is a side view of the ballast according to the present invention. [Figure 33] This is a bottom view of the ballast according to the present invention. [Figure 34] This is a cross-sectional view of the ballast according to the present invention, taken along the line 34-34 in Figure 33. [Figure 35] This is a side view of the stabilization device for a shredding machine according to the present invention. [Figure 36] This is a cross-sectional plan view showing the shredding machine stabilizer in a locked configuration according to the present invention. [Figure 37A] This is a plan view showing the ballast according to the present invention in an unlocked configuration. [Figure 37B] This is a cross-sectional plan view showing the shredding machine stabilizer in an unlocked state according to the present invention. [Figure 38] This is a top-down perspective view of a storage bag placed inside a body opening according to the present invention. [Figure 39] This is a top-down perspective view of a storage bag placed inside the body opening and a non-locking type shredding stabilizer connected to the storage bag, according to the present invention. [Figure 40] This is a top-down perspective view of a shredder having a protective plug connected to a stabilizing cap according to the present invention. [Figure 41] This is a perspective view from below of a shredding device having a protective plug connected to a stabilizing cap according to the present invention. [Figure 42] This is a top-down perspective view of a shredder connected to a stabilizing cap according to the present invention. [Figure 43] This is a top-down perspective view of the stabilizing cap according to the present invention. [Figure 44] This is a top-down perspective view of the storage bag according to the present invention. [Figure 45] This is a cross-sectional side view of a tissue specimen in a containment bag arranged across the body wall according to the present invention. [Figure 46]This is a side view of the storage bag unfolding device according to the present invention. [Figure 47] This is a side view of the storage bag and deployment cap according to the present invention. [Figure 48] This is a top-down perspective view of the storage bag according to the present invention. [Figure 49] This is a cross-sectional side view of a tissue specimen in a containment bag arranged across the body wall according to the present invention. [Figure 50] This is a top-down perspective view of the storage bag according to the present invention. [Figure 50A] This is a top-down perspective view of the storage bag according to the present invention. [Figure 50B] This is a plan view of the storage bag according to the present invention. [Figure 50C] This is a top-down perspective view of the storage bag according to the present invention. [Figure 50D] This is a top-down perspective view of the storage bag according to the present invention. [Figure 50E] This is a plan view of a pattern for a storage bag according to the present invention, where solid lines indicate valley folds and dashed lines indicate mountain folds. [Figure 50F] This is a partial plan view of a pattern with dimensions for a storage bag according to the present invention. [Figure 50G] This is a plan view of a pattern for a storage bag that is substantially square when viewed from above, according to the present invention. [Figure 50H] This is a plan view of a storage bag having a triangular opening end according to the present invention. [Figure 51] This is a perspective view of the guard according to the present invention, seen from above. [Figure 52] This is a perspective view of the guard inside the mold according to the present invention, seen from above. [Figure 53] This is a perspective view of the guard on the mold according to the present invention, seen from above. [Figure 54] This is a top-down perspective view of the storage bag according to the present invention. [Figure 55A] This is a side view of the ring of the storage bag according to the present invention. [Figure 55B] This is a cross-sectional view of the ring of the storage bag according to the present invention, taken along the line 55B-55B in Figure 55A. [Figure 56A] This is a top-down perspective view of a semi-rigid rod before it is formed within a ring for a storage bag according to the present invention. [Figure 56B] This is a perspective view of the ring of the storage bag according to the present invention, seen from above. [Figure 57A] This is a plan view of the side wall of the storage bag according to the present invention. [Figure 57B] This is a side view of the side wall of the storage bag according to the present invention. [Figure 58A] This is a side view of the storage bag according to the present invention. [Figure 58B] This is a cross-sectional view of the storage bag 58A according to the present invention, taken along the line 58B. [Figure 59A] This is a side view of the storage bag according to the present invention. [Figure 59B] This is a top-down perspective view of the storage bag according to the present invention. [Figure 60] This is a top-down perspective view of the bag introduction device according to the present invention. [Figure 61] This is a top-down perspective view of the bag introduction device according to the present invention. [Figure 62] This is a top-down perspective view of the containment bag and bag introduction device according to the present invention. [Figure 63] This is a top-down perspective view of the containment bag and bag introduction device according to the present invention. [Figure 64] This is a perspective view of the guard according to the present invention, seen from above. [Figure 65] This is a cross-sectional side view of a tissue specimen in a containment bag and guard arranged across the body wall according to the present invention. [Figure 66] This is a perspective view of the guard according to the present invention, seen from above. [Figure 67] This is a side view of two side wall components of the guard according to the present invention. [Figure 68] This is a perspective view of the guard according to the present invention, seen from above. [Figure 69] This is a side view of the guard according to the present invention. [Figure 70] This is a side view of a guard inside a body opening according to the present invention. [Figure 71A]This is a perspective view of the guard according to the present invention, seen from above. [Figure 71B] This is a perspective view of the guard according to the present invention, seen from above. [Figure 72] This is a perspective view of the guard according to the present invention, seen from above. [Figure 73] This is a partially perspective side view of the guard according to the present invention. [Figure 74] This is a partially perspective side view of the guard according to the present invention. [Figure 75] This is a cross-sectional view of the side wall of the guard according to the present invention. [Figure 76] This is a perspective view of the guard according to the present invention, seen from above. [Figure 77] This is a side view of the guard according to the present invention. [Figure 78A] This is a translucent bottom view of the guard according to the present invention. [Figure 78B] This is a translucent plan view of the guard according to the present invention. [Figure 78C] This is a cross-sectional view of the guard according to the present invention, taken along the line 78C-78C in Figure 78B. [Figure 79] This is a partial perspective view of the guard according to the present invention, as seen from above. [Figure 80] This is a plan view of the guard according to the present invention. [Figure 81] This is a plan view of the guard according to the present invention. [Figure 82] This is a perspective view of the guard according to the present invention, seen from above. [Figure 83] This is a perspective view of the guard according to the present invention, seen from above. [Figure 84] This is a cross-sectional plan view of the guard according to the present invention. [Figure 85] This is a perspective view of the guard according to the present invention, seen from above. [Figure 86] This is a perspective view of the guard according to the present invention, seen from above. [Figure 87] This is a side view of the shredding device and guard according to the present invention. [Figure 88] This is a cross-sectional side view of the shredding device and guard according to the present invention. [Figure 89]This is a perspective view from below of the shredding device according to the present invention. [Figure 90] This is a top-down perspective view of the energy-type shredder and gripper according to the present invention. [Figure 91] This is a perspective view of the guard according to the present invention, seen from above. [Figure 92] This is a partial perspective view of the guard according to the present invention, as seen from above. [Figure 93] This is a side view of the guard according to the present invention. [Figure 94] This is a partially perspective side view of the guard according to the present invention. [Figure 95] This is a side view of the guard according to the present invention. [Figure 96] This is a partially perspective plan view of the guard according to the present invention. [Figure 97] This is a cross-sectional plan view of the guard according to the present invention. [Figure 98] This is a partially perspective cross-sectional plan view of the guard according to the present invention. [Figure 99] This is a partially perspective side view of the retractor and guard according to the present invention. [Figure 100] This is a cross-sectional side view of the retractor and guard according to the present invention. [Figure 101] This is a top-down cross-sectional perspective view of the retractor and guard according to the present invention. [Figure 102] This is a top-down cross-sectional perspective view of the retractor and guard according to the present invention. [Figure 103] This is a partial perspective view of the retractor and guard according to the present invention, as seen from above. [Figure 104] This is a side view of the guard according to the present invention. [Figure 105] This is a plan view of the guard according to the present invention. [Figure 106] This is a top-down perspective view of the retractor and guard according to the present invention. [Figure 107] This is a plan view of the retractor and guard according to the present invention. [Figure 108] This is a perspective view from below the guard according to the present invention. [Figure 109A]This is a perspective view of the guard according to the present invention, seen from above. [Figure 109B] This is a perspective view of the guard according to the present invention, seen from above. [Figure 109C] This is a perspective view from below the guard according to the present invention. [Figure 109D] This is a plan view of the guard according to the present invention. [Figure 109E] This is a perspective view of the guard according to the present invention, seen from above. [Figure 109F] This is a perspective view from below the guard according to the present invention. [Figure 109G] This is a plan view of the guard according to the present invention. [Figure 110] This is a perspective view of the guard according to the present invention, seen from above. [Figure 111] This is a top-down perspective view of the two-part guard according to the present invention. [Figure 112] This is a top-down perspective view of the blade guard according to the present invention. [Figure 113] This is a top-down cross-sectional perspective view of the blade guard according to the present invention. [Figure 114] This is a cross-sectional view of the blade holder of the blade guard according to the present invention. [Figure 115] This is a perspective view of the blade according to the present invention, seen from below. [Figure 116] A top view perspective of the blade according to the present invention. [Figure 117] This is a top-down, disassembled and assembled perspective view of the blade guard assembly according to the present invention. [Figure 118] This is a top-down perspective view of the blade guard assembly according to the present invention. [Figure 119] This is a top-down cross-sectional perspective view of the blade guard assembly according to the present invention. [Figure 120] This is a top-down, disassembled and assembled perspective view of the blade guard assembly according to the present invention. [Figure 121] This is a top-down, disassembled and assembled perspective view of the blade guard assembly according to the present invention. [Figure 122]This is a top-down cross-sectional perspective view of the blade guard assembly according to the present invention. [Figure 123] This is a top-down cross-sectional perspective view of the blade guard assembly according to the present invention. [Figure 124] This is a bottom view of the blade guard assembly according to the present invention. [Figure 125] This is a top-down cross-sectional perspective view of the blade guard assembly according to the present invention. [Figure 126] This is a perspective view from below of the blade guard assembly according to the present invention. [Figure 127] This is a side view of the storage bag according to the present invention. [Figure 128] This is a top-down perspective view of the tissue gripper and shredder according to the present invention. [Figure 129] This is a cross-sectional side view of the handle of a tissue gripper according to the present invention. [Figure 130] This is a cross-sectional side view of the distal end of the tissue gripper according to the present invention. [Figure 131] This is a top-down cross-sectional perspective view of the distal end of the tissue gripper according to the present invention. [Figure 132] This is a cross-sectional side view of the distal end of the tissue gripper according to the present invention. [Figure 133] This is a top-down perspective view of the shredding device according to the present invention. [Figure 134] This is a perspective view from below of the shredding device according to the present invention. [Figure 135A] This is a side view of the storage bag according to the present invention. [Figure 135B] This is a plan view showing the storage bag according to the present invention in a rolled-up form. [Figure 135C] This is an end view showing the storage bag according to the present invention in a rolled-up form. [Figure 135D] This is an end view of the storage bag according to the present invention. [Figure 136A] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 136B] This is a cross-sectional side view of the body wall and the tissue specimen inside the containment bag and tissue guard according to the present invention. [Figure 137A]This is a side view of the storage bag according to the present invention. [Figure 137B] This is a plan view of the open storage bag according to the present invention. [Figure 137C] This is a cross-sectional view of the ring of the storage bag according to the present invention. [Figure 138A] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 138B] This is a cross-sectional side view of the body wall and the tissue specimen inside the containment bag and tissue guard according to the present invention. [Figure 138C] This is a cross-sectional side view of the body wall and the tissue specimen inside the tissue guard, which is wrapped around the bag ring according to the present invention. [Figure 139A] This is a side view of the storage bag according to the present invention. [Figure 139B] This is a plan view of the open storage bag according to the present invention. [Figure 139C] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 140A] This is a side view of the storage bag according to the present invention. [Figure 140B] This is a plan view of the storage bag according to the present invention. [Figure 141A] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 141B] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 141C] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 141D] This is a cross-sectional side view of the body wall and the tissue specimen inside the containment bag and tissue guard according to the present invention. [Figure 142A] This is a side view of the storage bag according to the present invention. [Figure 142B] This is a cross-sectional view of the storage bag according to the present invention, taken along the line 142B-142B in Figure 142A. [Figure 142C] This is a cross-sectional view of the inflated storage bag according to the present invention. [Figure 143A] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 143B]This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 143C] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 143D] This is a cross-sectional side view of the body wall and the tissue specimen inside the inflated containment bag and tissue guard according to the present invention. [Figure 144A] This is a side view of the storage bag according to the present invention. [Figure 144B] This is a cross-sectional view of the storage bag according to the present invention, taken along the line 144B-144B in Figure 144A. [Figure 144C] This is a cross-sectional view of the inflated storage bag according to the present invention. [Figure 145A] This is a cross-sectional side view of the body wall and a tissue specimen in a containment bag according to the present invention. [Figure 145B] This is a cross-sectional side view of the body wall and a tissue specimen inside an inflated storage bag according to the present invention. [Figure 145C] This is a cross-sectional side view of the body wall and a tissue sample inside an inflated containment bag that has been pulled upward according to the present invention. [Figure 145D] This is a cross-sectional side view of the body wall and the tissue specimen inside the inflated containment bag and tissue guard according to the present invention. [Figure 146A] This is a side view of the guard according to the present invention. [Figure 146B] This is a bottom view of the guard according to the present invention. [Figure 147A] This is a plan view of the guard according to the present invention. [Figure 147B] This is a side view of the guard according to the present invention. [Figure 148A] This is a side view of the guard according to the present invention. [Figure 148B] This is a plan view of the guard according to the present invention. [Figure 149] This is a top-down perspective view of the shredding and bagging system according to the present invention. [Figure 150A] This is a top-down perspective view of the electric shredder according to the present invention. [Figure 150B] This is a top-down cross-sectional perspective view of the electric shredder according to the present invention. [Figure 150C] This is a cross-sectional view of the electric shredder according to the present invention. [Figure 150D] This is a cross-sectional view of the electric shredder according to the present invention. [Figure 151] This is a top-down perspective view of the specimen container according to the present invention. [Figure 152] This is a cross-sectional perspective view of the bag tube and bag according to the present invention, as seen from above. [Figure 153A] This is a top-view cross-sectional perspective of the storage bag according to the present invention, shown in an open state. [Figure 153B] This is a top-view cross-sectional perspective of the storage bag according to the present invention in a closed state. [Figure 154A] This is a top-view cross-sectional perspective of the storage bag according to the present invention, shown in an open state. [Figure 154B] This is a top-view cross-sectional perspective of the storage bag according to the present invention in a closed state. [Figure 155A] This is a top-view cross-sectional perspective of the storage bag according to the present invention, shown in an open state. [Figure 155B] This is a top-view cross-sectional perspective view showing the gripper and storage bag according to the present invention in an open configuration. [Figure 155C] This is a top-down cross-sectional perspective view of a storage bag wrapped around a gripper according to the present invention. [Figure 156A] This is a top-view cross-sectional perspective of the storage bag according to the present invention, shown in an open state. [Figure 156B] This is a top-view cross-sectional perspective of the storage bag according to the present invention in a closed state. [Figure 157A] This is a top-view cross-sectional perspective of the storage bag according to the present invention, shown in an open state. [Figure 157B] This is a perspective view showing the storage bag according to the present invention in a closed state. [Figure 158A] This is a plan view of the guard according to the present invention. [Figure 158B] This is a side view of a guard attached to the shaft of a shredding machine according to the present invention. [Figure 158C] This is a plan view of a guard attached to the shaft of a shredding machine according to the present invention. [Figure 158D] This is a cross-sectional side view of a guard and storage bag attached to a shredding machine shaft according to the present invention. [Figure 158E] This is a cross-sectional plan view of a guard attached to the shaft of a shredding machine according to the present invention. [Figure 158F] This is a cross-sectional side view of a guard attached to the shaft of a shredding machine according to the present invention. [Figure 159] This is a top-view cross-sectional perspective of a storage bag equipped with a bag tube and a top opening according to the present invention. [Figure 160] This is a cross-sectional side view of a storage bag equipped with a bag tube and a side opening according to the present invention. [Figure 161] This is a cross-sectional side view of a storage bag equipped with a bag tube and a side opening according to the present invention. [Figure 162A] This is a side view of a tissue sample in a containment bag according to the present invention. [Figure 162B] This is a cross-sectional side view of a tissue sample in a storage bag attached to a shredding device according to the present invention. [Figure 162C] This is a plan view of a storage bag attached to a shredding machine according to the present invention. [Figure 163A] This is a cross-sectional side view of the storage bag / shredding system according to the present invention. [Figure 163B] This is a cross-sectional side view of a body wall, a tissue sample, and the containment bag / shredding system according to the present invention. [Figure 163C] This is a cross-sectional side view of a body wall and a tissue sample in the containment bag / shredding system according to the present invention. [Modes for carrying out the invention]

[0018] The following description is provided so that those skilled in the art can manufacture and use surgical tools and carry out the methods described herein, and the following description relates to the optimal embodiment planned by the inventors who are carrying out their inventions. However, various modifications will remain obvious to those skilled in the art. These modifications are assumed to fall within the scope of the invention. Different embodiments or aspects of such embodiments are shown in various figures and described throughout the specification. However, it should be noted that each embodiment and its various aspects, although shown or described separately, can be combined with one or more other embodiments and their various aspects unless otherwise specified. Each combination is not explicitly described simply to ensure readability of the specification.

[0019] Referring next to Figure 1, the closed-loop technique of the present invention is shown. A small incision is made in the patient at the location of the abdominal wall 10, and the body cavity 12 is accessed through an opening 14 provided across the abdominal wall 10. Using laparoscopic techniques and instruments, such as a trocar, laparoscope, gripper, and knife, a single site opening can be made, the target tissue can be located, and the target tissue can be dissected from the surrounding tissue structure. Additional incisions or access sites can be used to insert instruments and scopes to facilitate the performance of the loop technique. The target tissue 16, for example, at least a portion of the uterus in a hysterectomy, is completely dissected, and the specimen collection bag 18 is inserted through the opening 14 provided in the abdominal wall 10 and placed in the body cavity 12. The bag 18 can be fed through a trocar or cannula provided across the abdominal wall 10. The bag 18 is spread and oriented in the body cavity 12. The target tissue 16 is placed into the bag 18 through an opening 20 provided in the bag 18. Various types of bags 18 can be used. The bag 18 is preferably transparent so that its contents can be observed from the outside of the bag 18 by a scope placed in the body cavity 12 through a secondary incision site made across the abdominal wall 10. It is also preferable to illuminate the contents of the bag 18 from the outside. The location of the target tissue 16 can also be observed through the transparent bag 18, thereby confirming the progress of the dissection and the position and proximity of the target tissue 16 to the opening 14. Furthermore, the condition of the bag 18 can be confirmed by observing it using the secondary site insertion method, thereby confirming that the bag is not tangled or twisted, and that the specimen is brought close to the opening, in which case the bag 18 is not being pulled together with the specimen. If the bag 18 is being pulled together with the specimen, as a result, the bag may accidentally come into contact with the blade and be cut. Opaque bags 18 can also be used. The material of the bag 18 is also important. Generally speaking, when made of plastic, the bag is strong enough to withstand pulling and tugging, has sufficient scratch resistance, is relatively thin and flexible, and is resistant to punctures and tears. The bag can be folded to reduce its dimensions, so that it can be inserted through a small incision / trocar with a diameter of at least 5 mm.Furthermore, when opened, the bag receives large tissue fragments, extends through the opening 14 to the surface of the abdominal wall 10, and is large enough to create a sufficiently large working space within the bag 18 for instruments, a scope, a shredder 24, and a knife 26, as shown in Figure 1. The bag 18 has a tether or drawstring 22 configured to tighten the opening to a closed position or to open the bag 18. The bag 18 can withstand inflationary pressure and does not leak. Various embodiments of bags and devices for inserting, deploying, and / or retrieving bags are provided in or integrated into a shredding system configured to allow the containment of an object to be shredded according to various embodiments of the present invention, in the entire system, in several parts of the system, or in combination of the system and / or its components. These embodiments are described in U.S. Patent Application No. 08 / 540,795 filed on 11 October 1995, No. 11 / 549,701 filed on 16 October 2006, No. 11 / 549,971 filed on 16 October 2006, No. 12 / 902,055 filed on 11 October 2010, and No. 13 / 252,110 filed on 3 October 2011, which are incorporated herein by reference and whose entire disclosures are incorporated herein by reference as if they were entirely contained herein. Additional bag variations are described below in detail.

[0020] After positioning the target tissue 16 inside the bag 18, grasp the tether 22 by hand or with a laparoscopic grasper and pull at least a portion of the bag 18 into the abdominal wall opening 14. Pulling the tether 22 closes the bag opening 20. It is preferable to enlarge the initial incision to approximately 15-40 mm, and then pull the bag 18 into the opening 14. If the target tissue 16 is too large to pass through the opening 14 while stuck, the target tissue 16 will be located in the body cavity 12 below the abdominal wall 10. Pull the remainder of the bag 18, including the opening 20, into the abdominal wall opening 14, and extend this remainder through the opening 14 to the outside of the patient's body, and along the upper surface of the abdominal wall 10 as shown in Figure 1. It is preferable to roll down the bag 18 and / or pull it taut across the surface of the abdominal wall 10, thereby maintaining its position and allowing some tissue retraction at the opening 14.

[0021] The guard 28 is inserted into the bag 18 by passing it through the opening 20. The guard 28 has a diameter such that it is held in place when positioned within the incision / opening 14. The guard 28 can also retract tissue at the incision / opening and is therefore sometimes called a retractor. One variation of the guard 28 is shown in Figures 2 to 6, and another variation is shown in Figures 7 to 10. The guard 28 has an inner surface 30 and an outer surface 32 that define the interconnected side walls between the apex 34 and the base 36. The inner surface 30 defines the central lumen 38 extending between the apex 34 and the base 36. The inner surface 30 has a curved funnel-shaped portion that is located near the apex 34 and is preferably convex or truncated cone-shaped. The guard 28 has a top circumferential flange 40 and a bottom circumferential flange 42 that extend radially outward to form surfaces that abut against the upper and lower surfaces of the abdominal wall 10, respectively. The top flange 40 may have features such as holes for securing the guard 28 to the bag 18 through, for example, a tether 22. The guard 28 has an overall length of approximately 2.5 inches (6.35 cm), but guards of various lengths can be used depending on the thickness of the tissue wall 10 to be penetrated. Variable-length guards 28, such as retractable or nesting guards 28, are included in the scope of the present invention. The inner diameter of the guard 28 at intermediate lengths is approximately 1.3 inches (3.30 cm), which may be as small as approximately 0.6 inches (1.52 cm). The outer diameter of the guard 28 at the intermediate length is approximately 1.6 inches (4.06 cm), which fits the incision / opening so that the apical circumferential flange 40 is held in place because the overall diameter of the apical circumferential flange 40 is larger than the diameter of the guard 28 at the intermediate length. The wall thickness at the intermediate length is approximately 0.16 inches (4.06 mm), which may be as thick as approximately 0.3 inches (7.62 mm). The guard 28 is made of any polymer, such as Kraton® or polyethylene, but the guard may be made of any suitable material including metal. The guard 28 is preferably flexible so that it can be slightly compressed to facilitate insertion through the opening 14 in the abdominal wall 10.The thickness of the guard 28 and / or the choice of materials for the guard 28 are selected so that the guard 28 can withstand cutting and puncturing forces from blades, knives, mites, shredders, etc. The guard 28 acts as a cutting plate or surface against which the target tissue is placed for cutting prior to removal. The target tissue 16 is grasped with a laparoscopic grasper and pulled upward toward the opening 14. Next, at least a portion of the target tissue 16 to be cut is held in place at the position of the guard 28 somewhere along the length of the guard 28. Next, a blade, such as a mite or shredder, is brought into contact with the portion of the target tissue to be cut at the position of the guard 28, and this portion of the target tissue is cut. The cut portion of the target tissue is pulled through the opening 14 toward the surface outside the patient's body, and the new section of the target tissue is brought toward a position along the guard 28, cut, and removed. This process is repeated until the entire specimen is removed, either whole or partially, from the bag 18. The guard 28 serves as a means of protecting the bag 18. The physician can freely cut the target tissue at the location of the guard 28 and further against the inner surface 30 of the guard, thereby reducing the impact of cutting the bag 18 with a knife or shredder. The guard 28 not only protects the specimen collection bag 18 from accidental incision, but also protects surrounding tissues, such as the abdominal wall, from accidental incision. The guard 28 maintains the integrity of the bag 18 and effectively maintains the closed incision system. The surgeon can quickly and safely reduce the specimen and remove it from the abdominal cavity.

[0022] Once the guard 28 is in place, the surgeon grasps the specimen 16 and pulls it up as far as possible through the incision. Next, the surgeon begins to cut the specimen 16 with the knife 26, reducing its size. Ideally, the surgeon "cores" or "peels off" the surface of the specimen 16 to keep as much of the specimen as possible intact. However, with a probability of more than 50%, the specimen 16 ends up in the form of numerous small pieces. While cutting through the incision, the surgeon can maintain pneumoperitoneum in the abdominal cavity 12, and as a result, the progress of the cutting can be observed laparoscopically through a lateral port placed in the abdominal cavity 12 at a secondary site. The lateral port is located outside the bag 18, and the surgeon can view it through the transparent bag or directly in the bag, thereby ensuring that the bag maintains its integrity. Once the specimen 16 has been shredded, crushed, and reduced in size enough to pass through the incision and pull out the remaining portion, the guard 28 is removed and its contents, including the bag 18 and the fragments generated during shredding, are withdrawn from the patient. The bag 18 prevents any remaining fragments from remaining in the abdominal cavity 12 and maintains a closed system, in contrast to the traditional shredding method, where the surgeon must return and painstakingly search for and collect scattered fragments in the pelvic cavity to prevent potential dissemination of new tumor sites. The surgeon can then choose to view the patient laparoscopically and then close the incision.

[0023] Abdominal removal and dissection have been described, but the above procedure can also be performed by going through the vaginal opening even if the cervix has been removed. Following the same process, a bag 18 is introduced and the specimen 16 is placed into the bag 18 laparoscopically. The tether 22 is pulled through the vagina rather than through the abdominal wall opening 14. In the same way, the specimen 16 sits at the bottom of the vagina, while the bag 18 proceeds through the vagina and opens outside the patient's body. The surgeon may roll up the bag 18 or pull it taut to maintain its position and provide some retraction. The surgeon places a guard 28 through the vagina to protect the integrity of the bag 18 and maintain its closed system, grasps the specimen 16 and removes it, and then dissects it to reduce its size. The dissection of the specimen is performed at the location of the guard 28 and / or against the surface of the guard 28, thereby protecting the surrounding tissue and bag from accidental incision. The surgeon can maintain the pneumoperitoneum and observe the progress of the shredding laparoscopically. Once the specimen 16 has been shredded, fragmented, and reduced in size enough to pass through the vagina and draw out the remaining portion, the guard 28 is removed and the bag 18 and its contents, including the fragments generated during shredding, are withdrawn from the patient. The bag 18 prevents the remaining fragments from remaining in the peritoneal cavity, thereby preventing harmful substances, such as cancer cells, from being disseminated into the peritoneal cavity and maintaining a closed system. In contrast, with the traditional shredding method, the surgeon must return and painstakingly search for and collect the fragments scattered in the pelvic cavity and check whether or not there are any fragments in the pelvic cavity. The surgeon can choose to view the patient laparoscopically for the final time and then close the vaginal cuff and abdominal incision.

[0024] In one modification shown in Figure 11, the guard 28 is configured to be attached to a cap 44, for example, a GELSEAL® cap manufactured by Applied Medical Resources Corporation in California. The cap 44 has a rigid ring 46 that can be removably connected to the proximal end of the guard 28. The cap 44 has a lever 48 for locking the cap 44 to the guard 28. The cap 44 has a perforable portion 50 which can be made of gel and is configured to adhere tightly to an instrument inserted through the cap and maintain an intraperitoneal pneumoperitoneum state. Figures 12 and 13 show the cap 44 connected to the guard 28. A recall port 52 is preferably provided on the cap 44. The cap 44 is preferably snapped onto the guard 28 and sealed to it by the lever lock 48, thereby maintaining an insufflation state. Figure 14 shows the cap 44 with multiple ports 54. Each port 54 is configured to receive a laparoscopic instrument, and each port has one or more internal seals for a tight seal with the instrument in the inserted state. The multi-port cap 44 advantageously allows for the insertion of a gripper, laparoscope, and / or shredder through a single site.

[0025] Figures 15-17 show another modification of the guard 28, which has a balloon 56 at the distal end of the guard 28. The balloon 56 is shown in the inflated form in Figure 15. In the inflated form, the balloon 56 extends radially outward to form a wide flange for securing to the abdominal wall 10 in the abdominal cavity 12, thereby making it difficult for the guard 28 to be accidentally removed from the opening 14. Figure 16 shows the balloon in the deflated form, which allows the guard 28 to be easily inserted into and removed from the opening 14. The guard 28 in Figures 15-17 is also preferably connected to the cap 44. The guard 28 can be made of any polymer material, including polycarbonate or a similar material.

[0026] The funnel-shaped entry at the proximal end of the guard 28 has been described above. In another modification, the funnel-shaped entry may be radially extended outward to form a wide surface area, allowing the tissue to be cut while in contact with this wide surface area. The trumpet-shaped proximal end also helps to hold the bag in place outside the patient's body and between the guard 28 and the tissue margin 10. In another modification, the guard 28 has a truncated cone or curved trumpet-shaped distal end. The trumpet-shaped distal end may have an expanded radially extending flange that spreads the bag 18 laterally within the abdominal cavity. The trumpet-shaped distal end helps to keep the bag in an open position and away from contact with the specimen and away from the distal entry into the guard 28, thereby protecting the bag 18 from accidental contact with the blade. In the trumpet-shaped distal end modification of the guard 28, the distal diameter of the guard 28 at the distal opening is larger than the diameter of the guard 28 at the middle length. In a modified version of the trumpet-shaped proximal end of guard 28, the proximal diameter of the guard at the proximal opening is larger than the diameter of guard 28 at the intermediate length. In yet another modified version, guard 28 has a trumpet-shaped proximal end and a trumpet-shaped distal end, which retain the advantages of the modified versions described above.

[0027] Next, a method for tissue removal using a guard 28 with a cap 44 will be described. After completing a laparoscopic hysterectomy or any other dissection, the aforementioned specimen 16 is completely detached from the surrounding tissue and awaits removal. The surgeon inserts a specimen bag 18, which is preferably transparent to the pelvis, and places the specimen 16 inside the bag 18. Next, the surgeon grasps the tether 22 attached to the bag 18 using a laparoscopic gripper and pulls the bag 18 up, drawing it into the abdominal wall incision 14 where the trocar has already been placed. If necessary, the surgeon expands the incision to 15-25 mm before fully pulling the bag through. Since the specimen 16 is too large to pass through the opening 14 while stuck, the specimen 16 is located inside the pelvic cavity, directly below the abdominal wall 10, while the remainder of the bag 18 is pulled out of the incision and opened outside the patient's body as shown in Figure 1. The surgeon can roll down the sac or pull it taut to maintain its position and provide some retraction. Next, the surgeon inserts the guard 28 into the incision to protect the sac 18 and the abdominal wall 10 during the incision and retract the incision. The integrity of the sac is preserved and the closure system is maintained.

[0028] The guard 28 is positioned within the opening 28 of the bag 18 and then positioned within the incision so that the guard 28 extends across the tissue margin 10. The cap 44 is attached to the guard 28. The cap 44 is snapped onto the proximal apical flange 40, and the lever 48 of the cap 44 is moved to the locked position to secure the cap 44 to the guard 28. The guard 28 preferably has a reinforcing wire 58 to maintain the shape and rigidity of the apical flange 40. The wire 58 is visible in Figures 1, 5, 6, 10, and 12. With the cap 44 in place, it is preferable to inflate the bag 18. In one modification, air is inflated only into the bag 18 to inflate it toward the abdominal cavity 12. In another modification, air is inflated into both the bag 18 and the abdominal cavity 12. In yet another modification, air is inflated into both the bag 18 and the abdominal cavity 12 so that the pressure inside the bag 18 is higher than the inflated pressure in the abdominal cavity 12. Air is preferably supplied via a trocar inserted through the cap 44 or through the air supply port 52 of the cap 44. With the cap 44 in place, the electric shredder 24 is inserted into the bag 18 by passing it through the perforated portion 50 of the cap 44. In a modified example, if a multi-port cap 44 is used, the shredder 24 is preferably inserted by passing it through one of the ports 54. The surgical grasper is also inserted into the cap 44 either through the perforated portion 50 or one of the ports 54, and the target tissue is grasped and pulled proximal toward the opening into the central lumen 38 of the guard 28, where the target tissue is shredded within the protective zone provided by the guard 28. As described above, the guard 28 protects the bag 18 from being punctured, thereby helping to maintain a closed shredding system. The electric shredder 24 is positioned by passing its bladed distal end 60 through the gel cap 44 to a depth that maintains it within the protective area or length of the central lumen 38 and guard 28. The target tissue is pulled towards the blade 60 by the gripper for shredding and extraction. The extracted tissue will then travel through the central lumen of the electric shredder 24.

[0029] Instead of positioning the shredder 24 through the perforated portion 50 of the cap 44, a stabilizer is provided to help hold the shredder 24 in place at a certain depth within the protective zone in the central lumen 38 of the guard 28, in cooperation with the bag 18 or guard 28. By maintaining the shredder within the lumen 38 of the guard 28, the shredder 24 is prevented from contacting the wall of the bag 18 during the procedure, thereby protecting the bag from accidental tearing. Further modifications of the stabilizer are described below.

[0030] After positioning the shredder 24 and cap 44, the surgeon may choose to inflate the bag 18 and the abdominal cavity 12 with air. The surgeon can observe the position of the shredder 24 and the target tissue 16, as well as the integrity of the bag 18, thereby ensuring that the bag is not twisted or too close to the distal end 60 of the shredder 24. The observation is performed using a laparoscope positioned through a port 54 at the same incision site or through a secondary incision site which becomes a lateral port. The specimen 16 is grasped with a support hook (tenacula) and pulled into the electric shredder 24 to reduce its size. Ideally, the surgeon "cores" or "peels off" the surface of the target tissue to keep it as intact as possible. However, in more than 50% of cases, the target tissue will be divided into numerous small pieces. Once the specimen 16 has been shredded sufficiently to allow the remaining tissue to pass through the incision, the shredder 24, gel cap 44 or stabilizer, and guard 28 retractor are removed, and the bag 18 and its contents, including the fragments generated during shredding, are withdrawn from the patient. The bag 18 prevents any remaining fragments from remaining in the abdominal cavity 12, maintaining a closed system, in contrast to the traditional shredding method, where the surgeon must return and painstakingly search for and collect scattered fragments in the pelvic cavity to prevent potentially disseminating new tumor sites. The surgeon chooses to finally view the patient laparoscopically and then close the incision.

[0031] Abdominal removal and shredding have been described, but the above-mentioned electric shredding procedure can also be performed through a body opening, such as the vagina. Following the same process, a bag 18 is introduced and the specimen 16 is placed into the bag 18 laparoscopically. The tether 22 is withdrawn through the vagina, rather than through the abdominal wall opening 14. In the same manner, the specimen 16 is positioned at the bottom of the vagina, while the bag 18 proceeds through the vagina and opens outside the patient's body. The surgeon may roll down the bag 18 or pull it taut to maintain its position and provide some retraction. The surgeon places a guard 28 into the bag 18 via the vagina to protect the integrity of the bag and maintain the closed system, places a cap 44 over the guard 28, and positions the electric shredder 24 through the gel cap 44 or stabilizing cap. The surgeon then grasps the specimen 16 with a support hook and passes it through the electric shredder 24 via the vagina, thereby reducing the size of the specimen 16. The surgeon maintains the patient's pneumoperitoneum and observes the progress of the shredding laparoscopically. Once the specimen 16 has been shredded enough to allow the remaining portion to be pulled through the vagina, the shredder 24, gel cap 44 or stabilizing cap, guard 28 and / or retractor are removed, and the bag 18 and its contents, including the shredded fragments, are withdrawn from the patient. The bag 18 prevents any remaining fragments from being left in the abdominal cavity 12 and maintains a closed shredding system, in contrast to the traditional shredding method, in which the surgeon must return and painstakingly search for and collect any fragments scattered in the pelvic cavity, as well as check whether or not there are any fragments in the pelvic cavity. The surgeon may choose to view the patient laparoscopically for the final time and then close the vaginal cuff and abdominal incision.

[0032] Referring next to Figures 18 and 19, a retractor 62 is shown having a first ring 64 and a second ring 66 connected to each other by a flexible side wall 68. The retractor 62 is described in detail in one or more of the patent documents incorporated by reference in this application. The second ring 66 is preferably compressed and inserted through a small incision, in which the second ring 66 expands to form a means of fixation to the abdominal wall 10 in the abdominal cavity 12. The first ring 64 is located outside the patient's body above the abdominal cavity 10, and in this location, the first ring can be lowered while rotating or inverting itself to retract and widen the abdominal wall opening 14. The retractor 62 can be employed in any of the modifications described above. In use, the retractor 62 is inserted prior to the insertion of the bag 18 into the body cavity or body opening. In one modification, the first ring 64 has a larger diameter than the second ring 66, as shown in Figure 19. The larger diameter of the first ring 64 relative to the second ring 66 allows for working in a wide space to cut the tissue. The sidewalls 68 are made of polyurethane laminate or similar materials including nonwoven fabric that resists cutting of the sidewalls 68.

[0033] Figures 20A and 20B show the modified retractor 62 configured within the bag 70. The bag 70 has a first ring 64 and a second ring 66 connected to each other by flexible, substantially cylindrical side walls 68. The opening at the second ring 66 is closed by a hanging bag portion that forms the base 72 of the bag 70. The bag 70 is inserted and used in the same manner as described above with respect to the bag 18. The second ring 66 is compressed and then passed through a small incision into the abdominal cavity 12. The side walls 68 are rolled around the top ring 64 to retract and open the opening 14, and a guard 24, which can be connected to the first ring 64, may or may not be used at the opening in the bag 70. The specimen 16 is removed by manual or electric shredding in the same manner as described above. The first ring 64 can also be connected to the gel cap 44.

[0034] Next, referring to Figures 21-24, a bag 70 is shown, comprising only a first ring 64 forming an opening, flexible cylindrical side walls 68, and a base 72. The first ring 64 is elastic and compressible into a flattened, elongated shape suitable for advancing through a small incision or through the lumen of a trocar. The arrow shown in Figure 22 indicates the direction of vertical collapse of the bag 70. Next, the flattened bag 70 is then easily compressed laterally and deployed into the abdominal cavity. The first ring 64 is compressed to make it elongated. The compressed bag then takes on the original shape of the expanded first ring 64. In the expanded state, the bag 70 is easily oriented within the abdominal cavity 12. The flattened bag 70 is conveniently flattened within the abdominal cavity, and this bag has two sides. In the flattened state, the bag 70 is not facing upwards. This is because the specimen can be placed within the boundary of the first ring 64 regardless of which side is used. The first ring 64 serves as a periphery guide for specimen placement, and it is preferable that the first ring be brightly colored so that it can be easily observed with a laparoscope. After placing the specimen within the periphery of the first ring 64, the first ring 64 is grasped and lifted to place the specimen into the bag 70. The same applies to the two-ring bag 70 described above. As shown in Figures 23 and 24, the bag 70 may be twisted to form a spiral shape and crushed or its length shortened. This feature is advantageous not only for inserting the bag through a small incision but also for lifting the specimen closer to the opening of the bag when the specimen is being minced.

[0035] Next, referring to Figure 25, a guard 74 is shown which is configured to be used in conjunction with the retractor 62 shown in Figures 18 and 19 or the bag 70 shown in Figures 20 to 24. The guard 74 has a rigid ring 76, and a plurality of inwardly extending flaps 78 meet at the center or form an opening 80 at the center as shown in Figure 25. The flaps 78 are attached to the ring 76 such that these flaps flex relative to the ring 76, thereby allowing the target tissue 16 to be extracted beyond the flaps 78. The flaps 78 also flex distally, allowing instruments to be inserted beyond the guard. The flaps 78 are made of the same material as the guard 28, for example, polycarbonate, LDPE, HDPE or a similar material, so that the flaps 78 are sufficiently elastic and cut-resistant and resist penetration by blades, thereby protecting the retractor 62 or bag 70. The guard 74 may consist of a single ring 76 with a flap 78, or it may consist of two similar rings 76a, 76b, each having a flap 78a, 78b. The two rings 76a, 76b are connected to each other such that flap 78a is offset from flap 78b to form a layered flap structure that allows for protection between flaps 78a, 78b. The target tissue 16 is pulled up through the openings 80a, 80b and, when near the guard 76, the target tissue 16 is cut. The target tissue 16 can also be cut if it is positioned against the flaps 78a, 78b.

[0036] Referring next to Figure 26, the guard 74 has an upright, flattened peripheral wall 82 configured to snap into position below the first ring 64 or bag 70 of the retractor 62, as shown in Figure 29. The guard 74 may further have a flange 84 configured to snap into position with the first ring 64 or bag 70 of the retractor 62, as shown in Figure 28. Figure 27 shows a rigid guard 74 without a flap. The rigid guard 74 of Figure 27 provides a wide cutting surface, allowing target tissue to be cut while in contact with this cutting surface, and in this case does not flex as much as the guard 74 with a flexible flap 78. The guard 74 may further have a funnel-shaped hanging portion 86 that provides a high degree of vertical protection to the bag 70 / retractor 62 and / or wound. The guard 74 is positioned on top of the retractor 62 or bag 70 and within the periphery of the first ring 64. Next, the guard 74 is snapped onto the underside of the first ring 64 so as to connect the guard 74 to the first ring 64. The guard 74 is also made of a material that resists puncture when shredded and helps to keep the bag 70 or retractor 62 in place. In other modifications, the guard is configured to snap onto the ring.

[0037] Referring next to Figure 30, a trocar 88 having a first balloon 90 and a second balloon 92 is shown. The trocar 88 has a removable seal housing 94 with one or more seals that make contact with the instrument in the inserted state. The trocar 88 has a central lumen 96 that extends through the seal housing 94 and the trocar 88. The lumen 96 is dimensioned and shaped to receive the electric shredder 24. The trocar 88 may further have an embolizer (not shown) configured to penetrate the abdominal wall. The trocar 88 can be inserted through the gel cap 44 described above or directly through an incision made in the abdomen. Bags 18,70 can be deployed through the lumen 86, and the specimen 16 can be inserted into bags 18,70. The tether 22 of bag 18 or the first ring of bag 70 is pulled through the incision, and the trocar 88 is reinserted. The second balloon 92 is inflated. In the inflated state, the second balloon 92 extends laterally, pushing the bag 18,70 laterally and away from the distal end of the trocar 88, and away from the distal end with the blades of the shredder. The electric shredder 24 is inserted into the lumen 96 of the trocar 88. The shredder 24 is preferably prevented from extending beyond the distal end of the trocar 88 by a stopper formed on the trocar 88 that abuts against the shredder 24. A support hook is inserted into the lumen of the shredder 24, and the tissue is grasped and pulled towards the shredder. The tissue is cut and removed from the specimen bag. The first balloon 90 is inflated so that it is positioned above the abdominal wall. Both the first balloon 90 and the second balloon 92 help to hold the trocar 88 in place relative to the abdominal wall 10. Figure 31 shows another trocar 88 with a seal housing 94 and an air supply port 98 for inflating at least one of the balloons 92.

[0038] Next, with reference to Figures 32 to 39, the ballast 100 will be described below. The ballast 100 has a flange 102 configured to be coupled to the bag 18, 70 or guard 28. The ballast 100 has a central portion 104 that constitutes a lumen 106 and houses a lock 108. The lumen 106 is dimensioned and configured to receive the electric shredder 24. When inserted into the lumen 106, it is preferable to adjust the height of the shredder 24 relative to the abdominal wall and then lock the shredder in place with the lock 108. The lock 108 has an unlocking mode that allows the lever 110 to be released so that the shredder 24 can be translated vertically within the lumen 106. The lock 108 also has a locking mode that pushes the lever 110 to lock the translation of the shredder 24. The lock 108 works to increase the frictional force on the shaft of the shredder 24 that holds the lock in place.

[0039] Referring next to Figures 40 and 41, the ballast 100 is shown coupled to the electric shredder 24. The system in Figures 40 and 41 has a ratchet drive mechanism including a toothed bar provided on the shredder 24 and configured to engage with a pawl (not shown) in the central portion 104 of the ballast 100. A button 114 is provided on the ballast 100 to disengage from or engage with the pawl, for the purpose of unlocking or locking the ballast 100 from the shredder 24, thereby freeing or preventing their relative vertical translation. The shredder 24 has an integrated scope and illuminator 116, an air supply port 118, and a mechanical drive coupling 120 for rotating the shredder blade 122. The ballast 100 has a lower flange 102 extending outward to engage with a bag, retractor, or guard, as described above. In one modification, the ballast 100 is configured such that the operation of the shredder 24 is prevented when the ballast claws are within a certain range of the toothed bar 112, thereby providing a safety shut-off mechanism. As a result, the shredder 24 is not activated when it is too far away or beyond the range of the guard and therefore in a position where it could cause accidental contact with the bag. Another modification of the ballast 100 is shown in Figures 42 and 43, in which the same reference numerals are used to indicate the same parts. The ballast 100 has a different shape, with the claw element 122 visible in Figure 43.

[0040] Figures 44 and 45 show a bag 18 having a tether 22 and a flexible ring 64 located at the opening 20. The bag material may be transparent or opaque, and the ring 64 is compressible so that it can be inserted through a small incision. Wrapping the side wall 68 around the first ring 64 can reduce the height of the bag, thus allowing the specimen to be raised closer to the opening, thereby making the specimen accessible for shredding.

[0041] Figures 46 and 47 show a bag deployment or unfolding device 124 for the bag 18 of Figure 47. The device 124 is insertable through a trocar. The bag 18 has an opening 20, a tether 22, and a deployment cap 21.

[0042] Figures 48 and 49 show another modified bag having a first ring 64, a second ring 66, a side wall 68 between the first and second rings, and a base 72. The elastic second ring 66 positioned at the bottom of the bag 18 causes the bag to flare open when placed in the body cavity 12, and this elastic second ring also helps prevent the object from sticking to the specimen 16. After placing the specimen in the bag 18, the first ring 64 is pulled down to the surface of the abdominal wall 10 as shown in Figure 49.

[0043] Figure 50 shows a sac 18 having a first ring 64 made of nitinol that provides support to keep the sac 18 open within the abdominal cavity 12, while allowing for easy insertion through a small incision.

[0044] Figures 50A to 50D show the bag 18 in an uncollapsed, expanded, or partially expanded state according to various embodiments. As shown, the bag 18 has a closed end 126 and at least one open end 128. According to various embodiments, the open end 128 has a tether or drawstring 130 that surrounds the open end 128 of the bag 18. The open end 128 of the bag 18 is closed by operating the tether 130. The illustrated bag 18 has a plurality of pre-formed folds 132 or a predetermined deformation pattern provided in the wall 134 of the bag 18 between the closed end 126 and the open end 128 of the bag 18. In various embodiments, the bag 18 is formed to provide a tendency to collapse and flatten, in which case the open end 128 faces upward or toward the opening of the body cavity and has a maximum width, maximum diameter or maximum opening dimension, and the closed end 126 faces away from the opening of the body cavity and is configured to be flattened and stable along the body cavity and provides a minimum height. According to various embodiments, when a force is applied in one direction, the height of the wall 134 of the bag 18 increases to capture or surround the specimen inside the bag 18. Folds 132 or deformation patterns cause such an increase in the height of the bag 18 to occur in proportion to the direction in which the force is applied. According to various embodiments, weight, specimen or reverse force is applied to the bag 18 to further assist in the increase in the height of the bag 18, or in particular, the proportional increase in the height of the bag 18.

[0045] In one embodiment, the bag 18 is folded flat or accordion-shaped prior to placement in the patient's body. When placed, the bag 18 is flattened with its open end 128 positioned at the top and its closed end 126 positioned at the bottom. The closed end 126 is positioned at the bottom, for example, within the patient's body cavity. Thus, the open end 128 of the bag 18 remains open due to a pattern formed on the wall 134 of the bag 18, and therefore does not need to be held open. In addition, the pattern biases the open end 128 into an open position and resists closure. This reduces the difficulty and time required to place the specimen on and / or inside the bag.

[0046] The surgeon places the specimen on the open end 128 of the bag 18 or on the top of the bag 18, covering the open end 128. By pulling the tether 130, the walls 134 of the bag 18 are lifted and pulled around the specimen, thereby containing the specimen. The opposing tensile forces applied to the tether 130 and the weight of the specimen applied to the bag 18 cause the deformation pattern along the walls 134 of the bag 18 to widen or straighten. In one embodiment, the bottom or closed end 126 of the bag 18 has a weight or attachable weight to ensure that sufficient opposing force is provided to straighten the walls 134 of the bag 18 when the tether 130 is pulled. In one embodiment, one or more tabs 136 or several parts of the bag 18 around the open end 128 of the bag 18 are provided to also widen the walls 134 of the bag 18 or one or more folds 132 of the walls 134 by the force pulling the bag 18 out or towards an opening in the body cavity.

[0047] In one embodiment, when the bag 18 is pulled down by the weight of the sample, the shorter side of the bag 18 is pulled downward, reducing the overall storage size. According to various embodiments, one or more tabs 136 are provided at the open end 128 of the bag 18, located on the flattened side of the bag 18 to prevent the bag 18 from losing its overall storage size, in order to compensate for or reduce the reduction in overall storage size. Thus, in one embodiment, when the bag 18 is flattened, the distance along the edge of the bag 18 is longer than the distance along the cross-section of the bag 18. In one embodiment, the tether 130 is passed through the tabs 136.

[0048] For a specific desired height and / or width of the bag 18, the patterns shown in Figures 50E and 50F are used to optimally form a wall pattern that ensures proper deployment and handling (e.g., straightening and accommodating). In one embodiment, the bag 18 is preformed with the illustrated pattern, and the bag 18 is then heated to maintain its flat and patterned state. A tether 130 is attached or passed through the tab 136 at the open end 128 of the bag 18. Thus, the heat, pressure, or preformation conditions that bring the bag 18 to its initial flat, stabilized, and patterned state help to maintain the deformation pattern, thereby causing the bag 18 to collapse and deform or be biased when placed in a body cavity. A downward force applied to the center of the bag 18 helps to straighten or unfold the fold 132, thereby expanding or lengthening the bag 18 to enclose the specimen and increase its height. As shown in the figure, the valleys and / or peaks of the pattern may have the same height and / or width to further ensure a linear and constant or measured increase in size. In various embodiments, the valleys or peaks of the pattern may have different dimensions from each other and may apply equal force to the inner wall of the cylindrical deployment device, thereby reducing the force required to deploy the bag 18.

[0049] According to various embodiments, the top or open end and the bottom or closed end of the bag are twisted in alternating directions, thereby forming a spiral pattern on the wall of the bag. The bag and / or spiral body are heated or compressed to maintain their shape. The spiral folds help to keep the bag flat after insertion into the body. After placing the specimen on the open end of the bag, pulling the tether surrounding the open end of the bag causes the wall of the bag to expand or untwist. Thus, the opposing pulling forces applied to the tether or the open end of the bag, along with the weight of the specimen and / or the attached state or added weight at the closed end or bottom of the bag, cause the bag to untwist and enclose the specimen as the bag is pulled toward the opening of the body cavity. According to various embodiments, the open end has a first ring and / or the closed end has a second ring. The first and / or second rings may be reinforced with or have wires or rods to bias the open end to an open or expanded state to accept the sample, to increase the tendency for the bag to remain flat or unexpanded, or to provide weight to assist in the expansion of the bag, or to provide stability for the positioning of the bag or for the acceptance and capture of the sample.

[0050] According to various embodiments, the top or open end and the bottom or closed end of the bag are directly crushed toward each other. The wrinkles or folds in the bag wall between the open and closed ends are heated or compressed to maintain these patterns / shapes and help keep the bag flat after insertion into the body. After placing the specimen on the open end of the bag, pulling the tether surrounding the open end of the bag stretches the wrinkles in the bag wall or straightens the bag wall. Thus, the opposing pulling forces applied to the tether or the open end of the bag, along with the weight of the specimen and / or the attached or added weight at the closed end or bottom of the bag, cause the bag to straighten and enclose the specimen as the bag is pulled toward the opening of the body cavity. According to various embodiments, the open end has a first ring and / or the closed end has a second ring. The first and / or second rings may be reinforced with or have wires or rods to bias the open end to an open or expanded state to accept the sample, to increase the tendency for the bag to remain flat or unexpanded, or to provide weight to assist in the expansion of the bag, or to provide stability for the positioning of the bag or for the acceptance and capture of the sample.

[0051] As shown in Figures 50G and 50H, the bag 18 may have various top, base and overall shapes, including (but not limited to) cubes, prisms, cylinders, spheres, dodecahedrons, hemispheres, cones, cuboids, polyhedra, etc., and the bag may have one or more openings and may tend to remain in a collapsed or substantially flattened shape and may have various deformable wall patterns to expand linearly or in a controlled manner when operated to contain and enclose a specimen.

[0052] Various embodiments of an approach system to be included in or integrated into a shredding system, wherein the entire approach system, several parts of the approach system, or combinations of the approach system and / or its components are arranged to provide channels and / or substantially regions according to various embodiments of the present invention, are described in U.S. Patent Application No. 13 / 865,854 filed on April 18, 2013, No. 61 / 880,641 filed on September 20, 2013, No. 12 / 578,422 filed on October 13, 2009, No. 61 / 104,963 filed on October 13, 2008, No. 12 / 358,080 filed on January 22, 2009, and No. 11 / 374,188 filed on March 13, 2006. This includes the following specifications: the same specification No. 11 / 683,821 filed on March 8, 2007, the same specification No. 12 / 396,624 filed on March 3, 2009, the same specification No. 14 / 209,161 filed on March 13, 2014, the same specification No. 12 / 873,115 filed on August 31, 2010, the same specification No. 12 / 840,989 filed on July 21, 2010, and the same specification filed on October 2006. The disclosures described in U.S. Patent No. 11 / 548,758 filed on 12th of the month, U.S. Patent No. 10 / 516,198 filed on 30 November 2004, and U.S. Patent No. 10 / 666,579 filed on 17 September 2003 are incorporated herein by reference, and their contents are included as if they were contained herein.

[0053] Referring next to Figures 51 to 53, another modification of the guard or shield 200 of the present invention is shown. The guard 200 is shaped like a spiral overall. The guard 200 has a first inner end 202 and a second outer end 204. The first end 202 and the second end 204 are connected to each other by a central portion 206, also called a leaf or band. The guard 200 has a top end 212, also called a trailing end or proximal end, a bottom end 214, also called a leading end or distal end, and an inner surface 208 and an outer surface 210 connected to each other by the first inner end 202 and the second outer end 204. The central portion 206 or band has a concave outer surface 210, and the inner surface 208 forms an isomorphic surface that is convex when viewed from inside the spiral. In one modification, the depression of the band is parabolic, and the inflection point is located midway between the apex 212 and the base 214, although the invention is not limited thereto, and the inflection point may be located anywhere between the apex 212 and the base 214, or may even coincide with or substantially coincide with the apex 212 or the base 214. The band 206 does not have a depression, and the band 206 may simply curve along at least a portion of the guard 200 between the apex 212 and the base 214, or it may be straight. The guard 200 is shown as symmetrical, having an apex with the same outer diameter as the base. In another modification, the guard 200 is asymmetrical in shape, and this guard may have an apex with a larger or smaller diameter than the base. The guard 200 is also vertically symmetrical, but the invention is not limited thereto, and the guard 200 may have a central axis that is at an angle to a reference horizontal plane. The guard 200 has a spiral shape such that a portion of the band is curved and overlaps with another portion of the band in a circular or elliptical state. Specifically, at least a portion of the outer surface 210 of the band 200 overlaps with and faces at least a portion of the inner surface of the band 200, and a recess in a portion of the band 200 is located adjacent to or juxtaposed with a recess in another portion of the band, with the portion of the band being fitted and embedded within the other portion of the band.The spiral body is shown having a resting and mechanically unstressed form with one and a half turns, with a circumferential length of approximately 3πR, where R is the radius taken perpendicular to the longitudinal axis of the guard 200. The present invention is not limited to a guard having exactly 1.5 turns, and may have more or fewer turns as desired for a particular incision size, according to its dimensions, shape and desired force distribution state and function, e.g., retractor function and / or retaining function. A particular advantage of the spiral guard 200 is that its shape and dimensions can be changed, and it can be enlarged or reduced. Essentially, the band can slide against itself, thereby forming a large-diameter spiral form with a large diameter or a small-diameter spiral form with a small diameter. The spiral guard 200 has a central lumen 216 formed by the spiral body, and this spiral body can also be enlarged by expanding or opening the spiral body. The dimensions of the central lumen 216 can also be reduced by closing the spiral body or sliding the band into a tight curl state that produces many turns, or into a large curl state that produces a large diameter with fewer turns, thereby reducing the dimensions of the spiral. The central lumen 216 is substantially circular in shape, but the present invention is not limited thereto, and the central lumen 216 may be elliptical or non-circular in shape. Thus, the spiral shield 200 is adjustable when inserted together with other guards into a patient's wound or incision or into a bag placed in the patient's body as described above. Depending on the dimensions of the incision, the spiral shield 200 can be made larger or smaller by opening or closing the spiral shape, and many turns can be formed by curling the guard itself, thereby allowing it to fit accordingly to the wound opening or bag. Furthermore, the spiral shield 200 can be molded with a predetermined bias with respect to a specific rest or normal diametrical position, shape and dimensions.For example, if an incision of approximately 1 inch (2.54 cm) is made in the patient, the dimensions of the spiral shield 200, which has a resting diameter of approximately 2 inches (5.08 cm), can be reduced by twisting the spiral shield 200 itself, thereby increasing its number of turns and thus reducing its diameter. While in its reduced form, the spiral shield 200 is inserted into the 1-inch (2.54 cm) incision and then released. In contrast, since a bias is formed within the spiral shield 200, the spiral shield 200 tends to move towards its normal form, and thus expands from its reduced form, advantageously retracting the incision while simultaneously holding the spiral shield 200 and any object located between the shield 200 and the incision, such as a bag in position relative to the patient, adheres to or presses against. As a variation, the shield 200 can, advantageously, be reduced by tissue forces once inserted into the incision. Tissue forces on the shield can reduce the diametrical dimensions of the shield. Because the shield is adjustable, the dimensions of the central opening or lumen 216 can be increased by opening the spiral body for the removal of larger specimens. This adjustability is advantageous because it reduces strain on the surrounding tissue, keeps the incision site as small as possible, reduces the risk of infection, and at the same time allows the incision size to be made smaller or larger as needed by opening the spiral body to pull the specimen out of the body. In some cases, the dimensions of the tissue to be removed are unpredictable, and this adjustability is advantageous because it facilitates the removal of large tissue specimens without causing difficulties for the physician.

[0054] The position of the spiral shield 200 is further advantageous because, with the help of the curvature or recess of the band, it is retained against the incision site or a congenital body opening, such as the vagina. Specifically, the apical end 212 forms an apical lip, also called an apical flange, which extends circumferentially, at least in part, over the upper surface of the tissue. The basal end 214 forms a basal lip or basal flange, which extends circumferentially, at least in part, over the upper surface of the tissue within the patient's body cavity, the abdominal wall, or the surgical workspace, and advantageously retracts the tissue away from the cut surface of the shield 200, which is generally the inner surface 208 of the band. The tissue is received against the outer surface 210 of the band, and this tissue is fitted into the recess or curved shape of the outer surface 210, thereby keeping the shield and containment bag in place, and the flange prevents the shield from sliding down into or out of the patient's body. Naturally, the shield 200 is placed directly within a surgical incision / body opening or within any one or more of the containment bag and the wound retractor described above. Dissection can be carried out by any technique or method chosen by the surgeon, such as using the inner surface 208 of the shield 200 as a cutting plate, and preferably a blade is used to cut tissue that has been retracted by a gripper through or into the central lumen 216, with the tissue in contact with this cutting plate. Once the tissue to be dissected is pulled up through the central lumen 216, the tissue can be positioned against the inner surface 208 of the shield 200, and the tissue can be cut with a blade or knife while it is in contact with the shield 200. The shield 200 is made of a suitable material, for example, any polymer or metal. One suitable material is ultra-high molecular weight polyethylene plastic. Another suitable material is low linear density polyethylene. The shielding material has a thickness optimized to protect the tissue without being easily punctured or cut when the tissue is cut while in contact with the shielding material. Once the shredding is complete, it is preferable to reduce the diameter of the spiral shield 200 by rolling the shield itself into a reduced form that allows for easy removal from the surgical site.As a variation, the shield 200 may be removed by pulling it vertically or along the longitudinal axis of the shield.

[0055] Figures 52 and 53 show a spiral-shaped shield 200 on a core pin of a spiral-shaped molding mold 220. The spiral shield 200 is manufactured by injection molding, and is formed on the spiral mold 220. Once the core pin of the mold 220 is unwound, the shield 200 can be given its functional spiral shape by pushing one end in front of or behind an adjacent winding. Since the shield 200 is initially formed spirally and then spiral-shaped, it retains some springback tension memory, thereby attempting to take on a spiral shape rather than remaining perfectly spiral. If the shield 200 has an undesirable and excessive amount of spring bias tension, it is preferable to perform an annealing process by placing the shield 200 in an oven at a suitable temperature for an allocated time, and then removing it, thereby reducing or eliminating the residual tension within the shield 200. However, in one modification of the shield 200, some remaining tension is advantageously desirable because the tendency of the shield 200 to expand along its longitudinal axis facilitates the removal of the instrument from the incision site. A tab (not shown) may be formed on one end of the shield 200, e.g., the proximal end, medial end, or lateral end, and / or a hole may be formed near one end of the shield, through which a pull cord can be attached, so that the physician can easily remove the shield 200 from the incision site by pulling the cord or tab. The tab or hole can indicate directional priority in inserting the shield, so that the helical tension can be utilized when removing the instrument with the tab / hole located near the surgeon outside the patient's body. In one modification, a tab or hole is provided on a first medial end 202 that is isomorphized inside the winding for this removal feature. During removal, when the medial end 202 is pulled vertically, the band of the shield gradually stretches and exits the incision site.

[0056] As an alternative to injection molding, the spiral shield 200 may be manufactured from a plastic sheet material, die-cut, or thermoformed into a predetermined shape. Alternatively, instead of injection molding the shield 200 into a spiral shape, the spiral shield 200 may be directly injection molded into the shape of a spiral body.

[0057] Referring next to Figures 71A and 71B, the shield 200 is shown in an expanded elongated form and in a compressed or unexpanded form, respectively. The expanded form of the shield 200 is also shown in detail in Figures 72 to 74. In the expanded form, the shield 200 can be converted to the compressed form by overlapping the inner surface 208 onto the outer surface 210. The compressed form of the shield 200 is also shown in Figures 76 to 79. At least a portion of the shield 200 overlaps itself in the unexpanded form, as clearly shown in Figures 78A to 78C. Figure 78C shows the fitting of a portion of the shield 200 into a recess in the outer surface 210 of the adjacent overlapping portion of the shield 200. At least a portion of the shield 200 is designed to be wound or curled around the longitudinal axis 218. The shield 200 is configured such that at least a portion of it is wound or curled on itself around the longitudinal axis 218, so that a portion of the shield 200 overlaps with, juxtaposes with, or is in contact with another portion of the shield 200. When in the unexpanded configuration shown in Figure 71B, the shield 200 has a relaxed or normal lateral configuration in addition to a compact configuration in which the unexpanded configuration is wound into a tight roll with reduced diameter or lateral dimensions suitable for insertion into a wound or body opening. The shield 200 has a bias toward the relaxed or normal lateral configuration, and this shield tends toward this bias after insertion into a wound or body opening, thereby exerting some retraction force on the tissue as the shield 200 expands from a compact configuration to a larger configuration in response to the material used for the shield 200 and the forces exerted by the surrounding tissue in response to the shield 200 in its inserted state. If the wound or body opening is tight, the shield 200 does not need to expand from its reduced lateral insertion form, or it may only expand slightly in its lateral dimension as the shield tends to move towards its normal relaxed form, thereby slightly rolling out, or the shield 200 may expand completely to its normal relaxed form.

[0058] The vertically extended form of the shield 200 shown in Figure 71A is a result of the shield 200 being molded on a helical mold 220. The shield 200 defines a longitudinal axis 218 in which the center of the shield 200 is located. The shield 200 is made of a material that is biased toward the vertically extended position, at least in part. The shield 200 may be made of a shape memory material, or may have a portion made of a shape memory material. When in the vertically compressed state, the shield 200 does not spring into the vertically expanded state as a result of a bias toward the vertically expanded state, because the recess on the outer surface forms a top lip, also called a top flange 222, and a bottom lip, also called a bottom flange 224. As a result, at least a portion of the top flange 222 abuts against an adjacent overlapping top flange 222 while in the compressed state, and at least a portion of the bottom flange 224 abuts against an adjacent overlapping bottom flange 224 while in the compressed state, thereby preventing the vertically compressed state from easily shifting to the vertically expanded state. At least one of the top flange 222 and the bottom flange 224 acts as a stopper, preventing the shield 200 from expanding from the compressed state to the expanded state. The bias toward the expanded state imposes some frictional force on the device itself, and such frictional force helps to adjust the lateral or diametrical expansion of the shield 200. When in a compressed state, the shield 200 is preferably rolled / curled around its longitudinal axis, thereby reducing its diameter or lateral dimensions, thereby reducing the dimensions of the shield 200 and the diameter of the central lumen 216, thereby facilitating insertion through a small, minimally invasive incision or body opening.

[0059] Figure 80 shows the shield 200 in a relaxed or normal lateral configuration having approximately 1.25 times the circumference of the surrounding winding, with a central lumen 216 and a shield diameter 228 or outer diameter, each of which serves as the lateral or diametrical dimension for the shield 200, with a shield inner diameter or lumen inner diameter 226. Figure 81 is a plan view of the shield 200. In Figure 81, the shield 200 is in a compact configuration suitable for insertion into an incision / body opening, and the shield 200 rolls itself tightly through this incision / body opening. The shield 200 in Figure 81 has a lumen diameter 226 and shield diameter 228 that are reduced compared to the relaxed normal configuration in Figure 80, with a circumference of approximately 2.25 times or more of the surrounding winding. The overlapping portions of the shield 200 are in contact with each other and work to slightly maintain the reduced lateral diameter position through frictional action, but the shield 200 tends to take on its normal form because the bias of the lateral dimension is toward the unstressed or relaxed radial normal form. The compact form with reduced lateral dimension is designed to be properly inserted into a wound or body opening. From the compact form, when the shield 200 is released when positioned outside the wound or body opening, it expands from the reduced lateral dimension position to the normal unstressed lateral dimension form. This expansion in the field may be limited by the force exerted by the tissue in response to the force exerted by the inserted shield 200. The shield 200 has a circular shape and a central lumen 216 with a diameter, but the invention is not limited thereto, and variations include shields 200 having an elongated lumen 216 with a length greater than its width, such as an oval or elliptical lumen. Thus, the outer circumference of the shield 200 may or may not have a corresponding shape. In a modified example in which the outer circumference of the shield 200 has a shape that matches the shape of the central lumen 216, if the lumen 216 is circular, the outer circumference of the shield 200 is also circular, or if the central lumen 216 has an oval or elliptical shape, the outer circumference of the shield is also oval or elliptical.

[0060] As described above, the shield 200 has a top flange 222 and a bottom flange 224 as part of the concave outer surface 210 of the shield 200. While in the non-vertically extended configuration, the shield 200 is symmetrical as a whole with respect to a plane perpendicular to the longitudinal axis 218, in which case the top flange 222 and bottom flange 224 extend radially outward from the longitudinal axis 218 over appropriately equal distances, as shown in Figure 77. Referring to Figure 79, a modified version of the shield 200 is shown in which the shield 200 is not symmetrical with respect to a plane perpendicular to the longitudinal axis 218. In Figure 79, the top flange 222 extends radially outward from the longitudinal axis 218 over a longer distance than the bottom flange 224 extends radially outward from the longitudinal axis 218. Thus, the shield 200 forms a top flange 222 that is extended relative to the bottom flange 224. The enlarged top flange 222 advantageously provides a wide protective surface area for the surrounding tissue and / or the containment sac, as well as a wide cutting plate surface for use by the surgeon when cutting / reducing the tissue.

[0061] Referring to Figure 82, a modified version of the shield 200 with a finger pull or tab 230 is shown. The tab 230 is shown integrally molded at or near the first inner end 202 of the shield 200. The tab 230 extends from the first inner end 202 and the apex end 212 of the shield 200 and forms an extension that is made more easily grasped by the user, either by the user's fingers or by an instrument, such as a gripper. In one modification, the tab 230 has a hole 232 configured to provide a place for insertion of an instrument or finger. In another modification, the hole 232 is not provided. The tab 230 is configured such that when it is pulled upward or proximally as a whole, the shield 200 changes from a non-extended form to an extended form. As a result of an upward force applied to the first end 202 via the tab 230, the bottom flange 224 of the first end 202 detaches from the adjacent lower flange 224 of the shield 200, thereby separating the first end 202 from the mating position with overlapping curvature of the adjacent portion of the shield 200. When the proximal end of the tab 230 is pulled upward, this causes vertical expansion of the shield 200, firstly, as a result, the first inner end 202 detaches from the unexpanded configuration, and the remainder of the shield 200 gradually moves out of the mating juxtaposition in the unexpanded configuration and into the spiral shape of the expanded configuration of the shield 200. Figure 82 shows the shield 200 in the unexpanded configuration and the tab 230 integrally formed with the shield 200. In another modification, the tab 230 is a separate element attached to the first end 202 of the shield 200 by adhesive, staples, or other fasteners. In yet another modification, tab 230 has a tether attached to shield 200, and in yet another modification, tab 230 is a tether and not an extension of shield 200.

[0062] Referring next to Figures 83 and 84, a shield 200 with a lock 234 is shown. The lock 234 is configured to lock the lateral or diametrical dimensions of the shield 200 while the shield 200 is in its non-expanded state. When the shield 200 is in a fixed position, the forces of the surrounding tissue may cause the lateral or diametrical dimensions of the shield 200 to be smaller than the desired level. The shield 200 may have a relaxed, normal state while in its non-expanded state, but the internal bias of the shield 200 may not be sufficient to overcome the forces of the surrounding tissue or may not meet the surgeon's preference with respect to a particular procedure, or with respect to a particular instrument to be passed through the central lumen 216, or with respect to particularly large specimens of target tissue. In any case, the lock 234 is configured to lock the shield 200 and hold its lateral or diametrical dimensions in a substantially fixed state, and in particular to prevent a reduction in the lateral or diametrical dimensions due to forces from the surrounding tissue. For example, if the shield 200 is to be inserted into an incision or body opening relatively small compared to the lateral dimensions of the shield 200, the shield 200 is first reduced to a compact form, for example, as shown in Figure 81. While in the compacted form, the shield 200 is inserted into the incision or body opening. The force of the surrounding tissue in response to the inserted shield 200 should be greater than the bias that tends to return the shield 200 to its normal, relaxed form, which is not under stress. In such cases, the surgeon may request a large-diameter central lumen 216 for the shield 200 or to retract the surrounding tissue. Next, the surgeon expands the shield 200 to a large lateral or large diametrical form and locks this position with the lock 234 directed towards the shield 200. In one modified configuration, the lock 234 has a first notch 236 located at a certain distance proximal to the first inner end 202 of the shield 200 and near the apex end 212, and a second notch 238 located at a certain distance proximal to the second outer end 204 of the shield 200 and near the apex end 212. The notches 236 and 238 are located near the point where one end 202 of the shield 200 overlaps with the other end 204 of the shield 200 in the non-extended configuration.The shield 200 is shown in the unlocked state in Figure 83. To lock the shield 200, it is expanded laterally by widening it to form a large-diameter central lumen 216. The first notch 236 is overlapped with the second notch 238 to lock the shield 200 in a fixed diametrical / lateral position, while the remainder of the shield 200 maintains some degree of circumferential overlap around the periphery of the shield 200. Figure 84 shows the first notch 236 overlapping or interlocking with the second notch 238 in the locked state. While in the locked state, at least a portion of the first end 202 is located outside at least a portion of the second end 204, so that a portion of the inner surface 208 of the first notch 236 faces the outer surface 210 of the second notch 238. To unlock Shield 200, separate notches 236 and 238 from each other.

[0063] As described above, it is preferable to insert the shield 200 into the wound or body opening by rolling and / or crushing it to a small diameter, and then inserting it into the wound or body opening. Insertion of the shield 200 can be easily performed with common surgical instruments, such as clamps or grippers. Once inserted, the shield 200 will naturally open slightly, and the tissue will flex so as to collapse outward from its shape. In one variation, the shield has a lock 234 that can lock the shield 200 into a slightly larger diameter to which it naturally closes. The lock 234 has notches 236, 238 provided along the outer edge of the shield 200 near the first and second ends 202, 204 where the spiral material overlaps. These notches 236, 238 overlap each other in the locked state, and as a result, at least a portion of the inner end of the shield 200 snaps outward from the outer end of the shield 200. The exposure tab of lock 234 is clamped, creating an overlapping state that results in a mechanical interlock point.

[0064] Referring now to Figures 85 and 86, another modification of the lock 234 provided on the shield 200 is shown. The lock 234 has interlocking teeth. Specifically, a first pair of external teeth 240 is formed on the outer surface 210 near the first inner end 202 of the shield 200, and a second pair of internal teeth 242 is formed on the inner surface 208 near the second outer end 204 of the shield 200. The first pair of external teeth 240 extends substantially vertically, positioned in a recess near the first inner end 202. The second pair of internal teeth 242 extends substantially vertically, positioned in a recess near the second outer end 204. The external teeth 240 and internal teeth 242 may also be angled. In one modification, the teeth 240, 242 are inclined so that they can easily slide or rub against each other when they move from a decreasing lateral dimension to an increasing lateral dimension. The angle of the teeth locks these ends together and prevents the shield 200 from shrinking laterally due to tissue forces at the wound or body opening. The external teeth 240 and internal teeth 242 are configured to interlock with each other to prevent a reduction in the lateral dimension of the shield 200. Multiple internal teeth 242 and multiple external teeth 240 are formed along at least a portion of the periphery near the first and second ends 202, 204, allowing the position in which the shield 200 is locked to be adjusted as needed, and thus allowing the lateral dimension to be fixed as desired. The teeth 240, 242 are shown positioned within a midline perpendicular to the longitudinal axis 218, but the present invention may also have teeth located at any location along the vertical direction.

[0065] In another variation of the lock provided on the shield 200, the shield 200 is provided with a projection extending from its inner surface. The projection is preferably hook-shaped and is preferably configured to engage with a notch or opening provided in an adjacent portion of the shield 200. In one variation, the projection is located near one of the first inner end 202 and the second outer end 204, and the notch or opening is formed near the other of the first inner end 202 and the second outer end 204.

[0066] The shield 200 protects the tissue surrounding a wound or body orifice in the body from sharp objects, such as blades and trimmers, during surgery. The terms wound, body orifice, incision, and body opening are used interchangeably herein. A wound is generally a minimally invasive incision that penetrates the abdominal wall for laparoscopic surgery or other forms of surgery. In its expanded form, the shield 200 is a spiral spring consisting of a ribbon of material formed into a spiral body that generates an outward force when inserted into a wound or body orifice. The shield 200 also retracts the tissue within the wound or body orifice and provides an opening that crosses the abdominal wall or passes through a body orifice via a central lumen 216, the central lumen 216 which is circular in shape as a whole when viewed along the longitudinal axis 218. In one modification of the shield 200, the shield 200 is made by winding a ribbon of material that is not curved and is flat as a whole into a cylindrical or conical shape. In another modification, the curved ribbon shield 200 has a C-shaped vertical contour when viewed from the side. The proximal and distal edges, also called the apical and basal ends 212 and 214 respectively, have a larger diameter than the intermediate portion of the shield 200 that forms the apical flange 222 and basal flange 224. This C-shape is advantageous in that it allows tissue to enter at the wound opening and provides anchor-like fixation means so that the shield 200 does not easily detach axially from the wound or body opening during normal use. In one modification, the C-shape is a parabola, as shown in Figure 75. The apex of the parabola is located in a plane perpendicular to the longitudinal axis 218. In another modification, this apex is located between the apical or basal end 212 and the vertical midline.

[0067] Removing the shield 200 from the wound or body opening is achieved by first separating the interlocking features 234 from each other, grasping the exposed inner corner of the shield 200, curling it inward in the spiral direction of the material, and then pulling it upward along the longitudinal axis to remove it from the wound or body opening. The shield 200 advantageously progresses spirally into an expanded spiral shape. The shield 200 can be pulled out with the fingers or using common surgical instruments, such as clamps or grippers. One variation of the shield 200 is made of a cut-resistant but flexible plastic material. The choice of material and thickness contribute to the protective features. The shield 200 is flexible enough to be inserted and removed, but rigid enough to remain fixed and provide protection.

[0068] The shield 200 offers several advantageous features. One important feature provided by the sheet 200 is that the shield protects the surrounding tissue from sharp objects, such as blades, knives, and shredders. The shield 200 also serves as a protective measure for the containment bag in which it is contained, thereby preventing the containment bag from being punctured or cut by sharp objects, and thereby maintaining the containment of the biological specimen with a reduced risk of leakage. The top flange 222 serves as a broad nodal or cutting plate-like protective measure for the tissue, with the bag surface surrounding the wound or body opening. The top flange 222 is located on the tissue edge and / or above the containment bag, covering and / or protecting it. The middle portion of the shield 200 also shields the tissue at the wound or body opening and, if a containment bag is used, protects the containment bag in which the shield is contained. Furthermore, the intermediate section advantageously allows the surgeon to reach deeper areas with the blade and cut the tissue specimen near the intermediate horizontal plane perpendicular to or above the longitudinal axis, and even beyond the intermediate plane of the shield 200 to cut the tissue specimen distally, because the entire vertical length of the shield 200 provides protection from the surrounding tissue and the containment bag.

[0069] Another advantage of Shield 200 is that it has a fixation feature. Shield 200 is advantageously configured to fix itself within the wound and body opening due to its C-shaped design. The fixation feature dramatically simplifies and speeds up the fret cutting procedure, as it eliminates the need for sutures or another hand to hold Shield 200 in place during the procedure. Dual flanges (top and bottom 222, 224) are provided to fix Shield 200, thereby trapping tissue or abdominal wall within the C-shaped recess. The shield has a distal fixation member for positioning within the wound and a proximal fixation member for positioning outside the wound opening. A single flange, whether top or bottom, is also within the scope of the present invention. Furthermore, although the top flange 222 and bottom flange 224 are shown extending along the entire circumference of the top end 212 and bottom end 214, respectively, the present invention is not limited thereto, and one or more of the top and bottom flanges 222 and 224 may extend around at least a portion of the circumference. In such modifications, a finger-shaped extension may be formed in place of the circumferential bottom flange 224. The finger may be easily flexed along its longitudinal direction to allow for easy insertion, and then be able to move radially outward by spring action to a resting position below the abdominal wall or other tissue structure or body opening. The top flange 222 may also extend radially outward over a longer distance than the bottom flange 224, as shown in Figure 79, or vice versa, thereby providing a wide cut plate surface.

[0070] Furthermore, the shield 200 is advantageously designed to be easily inserted into and removed from a wound or body opening. The shield 200 has a vertically expanded form and a vertically unexpanded (unexpanded) form, which gives the shield 200 vertical variability. This allows for easy removal of the shield 200 by simply pulling one end of the shield 200 proximal, resulting in the shield 200 disengaging from adjacent and overlapping flanges and / or recesses and spirally progressing from the fitted unexpanded form to an expanded spiral shape. Tabs, holes, and / or tethers 230 are provided to assist in grasping and vertically pulling the shield 200. Furthermore, while in the fitted or unexpanded form, the shield 200 can move into a compact form by wrapping or curling the shield 200 around itself to form a small or tight circle and a more swivel around itself. The shield 200 can, advantageously, move laterally from its compact form by releasing the compacted form, and then the shield takes on a normal relaxed form with a relatively large lateral dimension. Another enlarged form is also provided by the shield 200, in which a larger lateral or diametrical position than the normal or relaxed form can be locked in place by a lock 234 formed on the shield 200. The lateral variability of the shield 200 allows for a reduction in lateral dimensions, thereby facilitating easy insertion into a wound or body opening. Furthermore, the shield 200 can be unlocked from the locked, increased-diametrical position by simply unlocking the shield and / or by unlocking the shield 200 and then curling the shield itself into a tightened form, thereby reducing its lateral dimensions and facilitating removal from a wound or body opening.

[0071] Furthermore, the shield 200 is advantageously self-deployable. After curling the shield 200 into a compact lateral form, the shield 200 is easily inserted into the wound or body opening and then released, at which point the shield tends to increase in size due to its spring bias. This lateral springback action helps the shield 200 automatically fit into the wound or body opening with minimal effort, while simultaneously providing protection and retraction to the tissue and / or containment bag, thereby keeping both away from sharp objects that may be encountered during normal procedures.

[0072] Furthermore, while in its vertically unexpanded state, the shield 200 has an overall outer diameter that is C-shaped or hourglass-shaped, in which case the proximal end flares outward radially from the longitudinal axis, the distal end of the shield 200 flares outward radially from the longitudinal axis, and the constricted portion is the narrowest lateral dimension along the plane between the proximal and distal ends of the shield. The flare (trumpet-shaped flaring) at the distal end of the shield 200 is advantageously a slope or funnel-shaped portion that facilitates the guidance and movement of target tissue into and through the shield 200.

[0073] The flexibility of the Shield 200 makes it easy to insert, deploy, and remove, and it can act as an anchor due to its expansion. The flexibility is advantageously balanced with its ability to provide protection to the surrounding tissue and / or the containment bag. The protection provided by the Shield 200, when properly implemented, is sufficient for manual trimming procedures, while at the same time giving the surgeon the freedom to use personal trimming techniques. The Shield 200 is inserted into the mouth of the containment bag, which can also be positioned within the neck of the containment bag or within the main compartment of the containment bag. The containment bag surrounds the Shield 200, which is trapped between the tissue / body opening and the Shield 200. The Shield 200 helps to retract the surrounding tissue and the surrounding containment bag material. The Shield 200 exerts sufficient force on the containment bag to keep it in a substantially fixed position, preventing it from sliding into the wound or body opening. A sufficient portion of the bag's proximal end is positioned on the proximal side of the shield and on the patient's outer surface, for example, over the abdomen, thereby forming a blanket that helps prevent contamination. The shield 200 is configured to hold the mouth of the containment bag in an accessible open position and to receive and support a manual or electric shredding device.

[0074] In another modification, the shield 200 is designed to be inserted into the vaginal canal and is therefore longer in length as shown in the figure. The shield 200 is preferable to have a shape-memory portion to aid in deployment. The shield 200 enables reliable and safe removal of endogenous samples and is easy to use, thereby reducing surgical time and cost. When combined with a containment bag, the shield 200 helps reduce the risk of contamination of healthy tissue by malignant cells during tissue sample collection and retrieval procedures.

[0075] Next, the bag 310 of the present invention will be described with reference to Figures 54 to 59. The bag 310 has a single opening or mouth 312. A semi-rigid, compressible plastic ring 314 is attached to the bag 310 at or near the mouth 312 of the bag. The ring 314 is compressible from a circular or large form to an oval or small form, so that the bag 310 can be inserted through a small incision. Once placed in the patient's body, the elastic ring 314 expands to its original uncompressible large form, thereby opening the mouth 312 of the bag 310 together with the ring. When placed in a flattened position in the patient's body, the ring 314 clearly constitutes the mouth 312 of the bag 310, and the opening 312 may be difficult to see under laparoscopy without the ring 314. In some cases, the opening 312 of the bag 310 may be difficult to find. Next, the opening 312 must be oriented within the patient's body so that the tissue is clearly positioned within the opening 312 and not positioned beyond it. In this invention, when the expanded ring 314 is positioned on the top of the bag 310, the tissue positioned within the ring 314 settles into the bag 310 when the ring 314 is lifted toward the incision. The empty bag 310 is positioned flat on a flat surface, and the ring 314 naturally falls above the bag 310. The elastic ring 314 allows the bag 310 to remain open in the abdominal cavity without assistance, thereby facilitating tissue capture.

[0076] After the tissue sample is placed in the ring 314, the ring 314 is pulled up toward the incision. A tether 316 is provided near the opening 312 of the bag 310 to assist the surgeon in pulling the bag 310 toward the incision. The tether 316 may have a tag 318 located at its proximal end, which remains outside the patient's body even after the bag 310 has been placed inside the patient's body. The tag 318 is also easily locatable inside the patient. A large tag 318 helps to quickly locate the tether 316 and pull it if necessary. The tether 316 may also be configured to tighten the bag 310 into a closed state, for the purpose of preventing the contents of the bag 310 from spilling out. In a variation, an additional tightening string may be provided, connected to the bag 310 and positioned below or above the ring 314, so that the tightening string closes the bag circumferentially. Other methods of closing or sealing, such as pressure fitting or a zipper, may also be provided.

[0077] When the bag 310 is pulled and positioned near the incision, the ring 314 is compressed from its expanded form to its compressed form so that the ring 314 can be pulled through the small incision. The ring 314 is compressed using a gripper or by hand through the incision opening. After the ring 314 has been pulled through the incision, a sufficient amount of the bag 310 is pulled together with the ring so that it is placed over and covers a portion of the patient's abdomen. Therefore, the bag 310 must be large enough to create an apron effect around the incision outside the patient's body. With the ring 314 and a portion of the bag 310 outside the patient's body, the remainder of the bag 310 and the tissue sample remain inside the patient's body.

[0078] The cross-section of the ring 314 is preferably circular, and this cross-section preferably has a hollow center to provide flexibility. In one modification, the cross-section of the ring 314 is elliptical, elongated, or oblong. In the illustrated modification, the ring 314 has a shape resembling a figure eight or having two connected circular cross-sections, resulting in small valleys 320 between the circles. Generally speaking, the cross-section of the ring 314 has a length greater than its width. This elongated cross-section allows the ring 314 to be turned or turned over by inverting the ring 314 outward or inward, causing the bag 310 to roll up over the ring 314 itself. Rolling the ring 314 in the opposite direction allows the bag 310 to be spread out from the ring 314. The elongated cross-section of the ring 314 is advantageous in keeping the sidewalls of the bag 310 rolled up over the ring 314. If the cross-section is circular, the ring 314 can easily rotate on its own, thereby unwinding the rounded sidewall of the bag 310. The self-rolling of the ring 314 pulls the bag 310 upward, bringing the specimen inside the bag 310 closer to the incision opening. The rolling action of the bag 310 reduces the bulk of the bag 310 located inside the patient's body and creates a taut apron precisely formed outside the patient's body. If the bag 310 is retracted too tightly, the ring 314 may twist. The tissue specimen is then removed from the bag 310 by shredding it with a blade or electronic shredder to a size and shape that can pass through a small incision and be removed from the bag 310. If the sidewall 328 of the bag 310 rolls on its own, a roll 330 can be formed adjacent to the ring 314 to facilitate the deployment shown in Figure 59. The ring 314 is compressed so that its compressed length aligns with the length of the roll 330, allowing for easy insertion.

[0079] Referring particularly to Figures 55 and 56, the ring 314 is formed from a single elongated piece 322 of plastic, which is formed into a circle or other shape by joining its free ends together. In another variation, the ring 314 is made from two or more parts, for example, two semicircles, which together form a circle of the same radius. The ends are not joined together and are held in their normal curved shape within a sleeve at the opening of the bag 310. The multi-part ring 314 facilitates the compression of the ring 314 into a smaller form. The ring 314 is approximately 0.38 inches (9.65 mm) high, 0.18 inches (4.57 mm) wide, and approximately 38 inches (96.52 cm) long. The thickness of the material forming the ring 314 is approximately 0.18 inches (4.57 mm).

[0080] Referring particularly to Figures 57-59, the bag 310 is made from a single sheet 324 of material. The material sheet 324 is folded lengthwise and the sides are heat-sealed, thereby forming a seam 326. In any bag 310, the weakest part is the area around the welded seam 326. As can be seen in Figure 57, there is no welded seam 326 at the bottom of the bag 310 where the force is most likely to be concentrated when removing the specimen, thereby giving the bag 310 a high critical strength. Furthermore, the material of the bag 310 is made of transparent 4.2 mil Inzii® film, which allows the surgeon to see through the sides of the bag 310 during surgery. Because it is possible to see through the bag 310, it is not necessary to puncture the sides of the bag 310 to achieve visualization. The film is elastic, giving the bag 310 good retraction. Bag 310 may also be made of U-5746 ripstop nylon with a polyurethane coating. The polyurethane coating makes the film airtight and heat-sealable. U-5746 is a military-grade material that is stronger than Inzii® film but has less retraction and is opaque. Bag 310 is approximately 16 inches (40.64 cm) long and 12 inches (30.48 cm) wide at the opening 312. The bottom of bag 310 is at an angle of approximately 45° to the side wall 328 at a distance of approximately 12.4 inches (31.50 cm) from the opening 312. Bag 310 is approximately 0.2 inches (5.10 mm) thick, and at the seam 326, bag 310 is approximately twice as thick. In another variation, bag 310 is a double bag, with one bag positioned inside the other to provide greater resistance to accidental punctures. In another variation, only the bottom of bag 310 is reinforced with a double-wall structure. Bag 310 is leak-proof and prevents the entry of viruses.

[0081] As described above, it is preferable that a shield be provided and used in conjunction with the bag 310. After the bag 310 is placed inside the patient's body and pulled through the incision, the shield is inserted into the opening 312 of the containment bag 310. The shield is made of thick plastic and protects the plastic bag 310 from being accidentally cut by a blade used by the surgeon to shred the target tissue. The shield may also serve as a cutting plate, allowing the surgeon to cut the target tissue with the cutting plate in place if necessary. The bag 310 can also be used with the retractor described above, in which case the bag 310 is pulled through the incision, the retractor is placed inside the opening 312 of the bag 310 to retract the tissue and bag 310 at the location of the incision, and then the shield is placed inside the retractor to remove the specimen.

[0082] Referring to Figures 60 to 63, a bag introducer or fork 410 is used to introduce the containment bag 310 into the patient's body cavity through a small incision. The introducer 410 facilitates the placement of the bag 310 into the surgical field. The fork 410 has a proximal end 412 and a distal end 414. A handle 416 is provided at the proximal end 412. A first branch 418 and a second branch 420 extend distally from the handle 416, forming a substantially fork-like shape. The branches 418 and 420 are of equal length. The branches 418 and 420 can have any suitable cross-section, and these branches are spaced a sufficient distance apart from each other. The branches 418 and 420 are made of stainless steel, and these branches are connected to an injection-molded plastic or metal handle 416 as shown in Figure 60. In this design example, a steel rod with branches 418 and 420 is inserted into and connected to an injection-molded handle 416, thereby enabling the realization of a fork 410 with a small profile; however, this method is expensive and time-consuming to manufacture. In Figure 61, the fork 410 is made from a single piece of material, in which case both the handle 416 and branches 418 and 420 are injection-molded to form a single integrated structure. This design example is the easiest and cheapest to manufacture, at the cost of a large profile and a weak design.

[0083] For use, referring particularly to Figures 62 and 63, the bottom of the containment bag 310 is positioned between the branches 418 and 420, with the tether 316 and tag 318 located near the handle 416. The bottom edge of the bag 310 is folded over the branches 418 and 420, with the branches extending slightly beyond the end of the bag 310. Therefore, the branches 418 and 420 are slightly longer than the width of the bag 310. The handle 416 is grasped and rotated, thereby allowing the bag 310 to be rolled evenly into a tubular roll 330 until resistance is felt. The bag 310 is reduced to the smallest size that can be introduced into the body. The elastic ring 314 is compressed, rolling the bag 310 into a round shape, until the bag 310 is taut and positioned next to the ring 314. With visualization possible, insert the bag 310 and fork 410 combination through the incision so that the opening 312 of the ring 314 is positioned upward. Insert the bag 310 until it is approximately 3 / 4 of the way into the incision. Rotate the fork 410 in the opposite direction to slightly loosen the bag 310. Loosening the bag 310 reduces the tension on the bag, thereby making it easier for the tissue to fall into the bag 310. The fork 410 allows for easy deployment of the bag 310, while controlling how tightly the bag 310 is wound and the direction of the ring opening 312 during insertion. If the bag 310 is wound too tightly, the tissue will not easily fall into the bag 310 even if the ring 314 is lifted within the patient's body. Rotating the introducer 410 in the opposite direction before removing it facilitates the insertion of tissue into the bag 310.

[0084] The fork 410 is separated from the bag 310 by pulling the handle 416 proximally. The remaining quarter of the bag 310 is pushed into the incision. After the bag 310 is fully deployed in the abdominal cavity, the access port and scope are positioned and air is supplied to the body cavity. The bag 310 is positioned so that the ring 314 is located on the top of the bag 310. It is preferable to position the access port in the same incision or a secondary incision. With visualization possible, the tissue to be shredded and removed from the patient is placed into the bag 310. It is preferable to visualize using the lateral access port and confirm that the tissue is present in the bag 310. The access port is withdrawn and the removal of the bag 310 from the patient's body is started. It is preferable to continue the removal and observation of the next shredding using the secondary access port, which does not need to be removed. The tag 318 should be located outside the patient's body. The tag is pulled to lift the bag 310 towards the incision. If tag 318 is located within a body cavity, it is best to grasp tag 318 using a grasper by visualization through an access port. Pull tether 316 and tag 318 through the incision until part of ring 314 passes through the incision. Pull ring 314 until the entire ring 314 is located outside the incision. Retract bag 310 by wrapping / flipping ring 314 around itself, causing bag 310 to wrap around ring 314. This wrapping of ring 314 not only slightly retracts the tissue but also reduces the bulk of bag 310 in the patient's body, thereby drawing the tissue in the patient's body closer to the surface. Next, shred the tissue.

[0085] As a variation, a retractor with a central lumen is placed into the mouth of the bag 310 at the incision site, and the tissue is retracted together with the bag 310, thereby widening the opening, and then the tissue is shredded while the bag 310 is in place. The retractor with a central lumen is placed into the mouth of the bag 310 at the location of the incision site, and the shield described above is prepared and used in conjunction with the bag 310 and the retractor. The shield is placed inside the central lumen of the retractor. Naturally, the shield can be used without a retractor. If a retractor is not used, the shield is placed inside the mouth 312 of the bag 310 at the location of the incision site. The shield is inserted into the mouth 312 of the containment bag 310 after the bag 310 has been placed in the patient's body, and then pulled through the incision site. The shield is made of thick plastic and protects the plastic bag 310 from being accidentally cut by a blade used by the surgeon to shred the target tissue. The shield can also serve as a cutting plate, allowing the surgeon to cut the target tissue while it is in contact with the plate if necessary. The shield itself can also function as a retractor with a first reducing dimension and a second expanding dimension. The second expanding dimension helps to retract the tissue.

[0086] When a retractor is used within a bag 310, the retractor advantageously retracts not only tissue but also a portion of the bag, thereby keeping the bag away from the shredding blade and protecting it from cuts and perforations. A typical retractor has a top ring and a bottom ring, with a flexible side wall connecting the top and bottom rings. The bottom ring is inserted through the incision, and this bottom ring is located inside the patient's body, while the top ring of the retractor is located above the patient. The top ring is rolled up / inverted like a bag, pulling the lower ring of the retractor closer and bringing the side walls taut between the rings. The lower ring of the retractor advantageously retracts a portion of the bag 310 inside the patient's body, preventing potential damage resulting from perforation and tearing by the blade.

[0087] The tissue is cut into pieces in the manner desired by the surgeon. Generally speaking, a small portion of the target tissue is pulled out of the patient's body while the majority of the target tissue remains inside the patient's body. The surgeon takes the blade and makes a circumferential cut of approximately 180° or 360° around the protruding tissue without cutting the tissue protruding from the rest of the target tissue. By keeping the protruding tissue intact with a larger piece inside the patient's body, the surgeon can continue to grasp the tissue without losing track of it in the bag. The surgeon pulls the grasped tissue out of the patient little by little, making periodic circumferential cuts of any size to pull out more of the tissue until the entire target tissue piece is removed. The result is a single elongated piece of removed target tissue, rather than numerous small pieces. If not removed as a whole, the target tissue is removed in several small pieces and in a more controlled manner. It is preferable to further retract the bag 310 between the pieces, thereby bringing the specimen closer to the surface. Once the tissue remaining inside the sac 310 has shrunk enough to easily pass through the incision while trapped in the wound, the sac 310 is completely removed.

[0088] Referring next to Figures 64 and 65, another shield 510 of the present invention is shown. The shield 510 has a first ring 512 located at the proximal end 514 and a second ring 516 located at the distal end 518. The rings 512 and 516 are substantially parallel to each other and connected to each other by a side wall 520. The side wall 520 is a woven sheath material which can be made of soft fibers or polymers. This material may be Kevlar®, Dyneema®, ripstop nylon, or a polymer compound. The side wall 520 is heat-sealed or bonded to the rings 512 and 516. The first and second rings 512 and 516 are semi-rigid and compressible between a large, normal high-profile form and a compressed, elongated low-profile form. The rings 512 and 516 are circular as a whole in these normal forms, but may also be elliptical. The rings 512 and 516 can be compressed from a circular or large shape to an oval or small shape, so that the shield 510 can be inserted into a small incision, particularly into the mouth of a containment bag to protect the shield. In one modification, only the second ring 516 is compressible so that it can be inserted into the incision, while the first ring 512 is rigid so that it is located outward or proximal to the patient's body. The rigid, proximal first ring 512 is preferably large and wide to serve as a large shield or cutting plate for shredding. The second or distally positioned ring 516 is preferably flexible so that it can be compressed and easily inserted into the bag, and is preferably slightly smaller in diameter than the first ring 512.

[0089] Preferably, one or more of the cross-sections of the rings 512, 516 are circular. The rings 512, 516 have a hollow center to provide flexibility. In one modification, the rings 512, 516 have an elliptical, elongated, or oblong cross-section with a hollow center. In another modification, the rings 512, 516 have a figure-eight-like shape with two connected circular cross-sections, as shown in Figures 55A and 55B, resulting in small valleys between the circles. Generally speaking, the cross-sections of the rings 512, 516 are longer than their width. This elongated cross-section allows each ring 512, 516 to rotate or flip itself by inverting the rings 512, 516 outward or inward to wrap the sidewalls 520 around the rings 512, 516. In one modification, only the first ring or proximal ring 512 is configured to wrap its sidewalls 520 in a rounded shape. In another variation, both rings 512 and 516 are configured to wrap the shield 510 in two directions, i.e., either the first ring 512 or the second ring 516 can be positioned proximal to the incision / body opening and wrapped around it. The shield 510 is inserted by compressing one or more of the rings 512 and 516. It is preferable to compress both rings 512 and 516 to create a low-profile shape that allows for easy insertion through the incision, but generally speaking, only the distal ring needs to be compressed, and the proximal ring, which is located outside the patient's body, does not need to be compressed. Also, only the proximal ring needs to be configured to wrap around the side wall 520 when the distal ring is located inside the patient's body. The length of the side wall 520 can be increased by wrapping one or more of the rings 512 and 516 configured to wrap in the opposite direction. When one of the rings 512 or 516 is rolled up, the length of the sidewall 520 is wrapped around the ring, thereby shortening the length of the shield 510. The elongated cross-section of the ring is advantageous in that it keeps the sidewall 520 wrapped around the ring in a rounded shape. If the cross-section is circular, the ring can be easily rolled up in the field, thereby unrolling the rounded sidewall 520. The rolling of the ring itself pulls the opposite ring upward and closer to this ring.

[0090] Rings 512 and 516 are made from a single elongated plastic piece formed into a circle or other shape by joining their free ends together. In another variation, rings 512 and 516 are made from two or more parts, for example, two semicircles that together form a circle for each ring. The ends are not joined together and are held in a normal curved shape. Multi-part rings can be easily compressed into a small, low-profile shape. The rings are approximately 0.38 inches (9.65 mm) high, 0.18 inches (4.57 mm) wide, and 38 inches (96.52 cm) long. The thickness of the material forming ring 314 is approximately 0.18 inches (4.57 mm). Figure 65 shows the shield 510 retracted by placing the first ring 512, positioned proximal and placed inside a bag 310, and rotating it so that the proximal rigid ring 512 is flush with the patient's outer surface or abdomen. The cut-resistant material of the rings 512, 516 and the sidewall 520 protects the bag 310. Retraction by winding the proximal first ring 512 advantageously elongates the incision. The resulting large incision makes manual shredding significantly easier. In another modification, the shield 510 is not configured to allow winding of one or more of the rings 512, 516 to reduce the length of the shield 510 and the sidewall of the shield 510 made of protective material.

[0091] Next, referring to Figures 66 and 67, another shield 510 of the present invention is shown. This shield 510 is substantially the same as the shield in Figures 64 and 65 in that it has a first ring 512 located at the proximal end 514 and a second ring 516 located at the distal end 518, and these rings are connected to each other by a flexible side wall 520. The modified side wall 520 shown in Figures 66 and 67 has a first layer 522 and a second layer 524, shown in a separated and flattened state in Figure 67. The first layer 522 has a plurality of vertical slits 526, and the second layer 524 has a plurality of vertical slits 528. The first layer 522 is positioned adjacent to or alongside the second layer 524 to form a lantern-shaped sidewall 520, and the slit 526 of the first layer 522 and the slit 528 of the second layer 524 are offset from each other, so that these slits do not bond to each other to form a tear through the shield 510. In contrast, overlapping layers 522, 524 with offset slits 526, 528 form a flexible yet rigid sidewall 520 that resists penetration. Each of the first layer 522 and the second layer 524 is a flexible or semi-flexible sheath that bends easily but is cut-resistant. The layers 522, 524 are flexible enough to facilitate insertion but are flexible enough to be retracted when positioned into the bag located within the incision, with or without inverting the rings 512, 516 as described above. In another variation, the slits 526, 528 are not perpendicular to the top and bottom edges of layers 522, 524, as shown in Figure 67. Instead, the slits 526, 528 are angled relative to the top and bottom edges. The overall height of the shield 510 is approximately 0.5 to 2.0 inches (1.27 to 5.08 cm), and the side walls 520 are made of protective material.

[0092] Next, referring to Figures 68 to 70, a shield 530 as another modification of the present invention is shown. The shield 530 is made of soft or semi-rigid plastic. The shield 530 has a substantially flattened flange 532 and an opening 534 provided in the middle. Viewed from the opening 534, a number of slits 536 extend outward from the periphery of the opening 534 into the flange 532, thereby increasing the flexibility of the corner intersection. The flange 532 is sized and shaped to fit into a retractor when a retractor is used. Specifically, the flange 532 snaps into place below the top ring of the retractor to help hold the shield 530 in place.

[0093] The flange 532 is connected to a central tubular section 538. The tubular section 538 has a central lumen extending from an opening 534 at its proximal end to an opening 540 at its distal end. The tubular section 538 may further have a number of slits 542 extending upward from the distal opening 540. The shield 530 further has two fingers or elongated extensions 544, which extend downward from the tubular section 538 at an oblique angle forming a first form with respect to the fingers 544. The fingers 544 have a second form, which is a reduced or compressed form as shown in Figure 69, in which the fingers 544 are pressed against each other or folded toward the longitudinal axis so that their lateral dimensions are the same as or smaller than those of the central tubular section 538. The reduced form facilitates insertion of the shield 530 into an incision or body opening. When inserted beyond the abdominal wall as shown in Figure 70, the finger 544 is advantageously configured to spring back into a first form, in which the finger 544 extends outward at a certain angle. In this first form, within the incision, the finger 544 advantageously retracts not only the tissue but also the sac into which it is inserted (not shown). The slit 542 provides further flexibility to the distal end of the central portion 538, so that the central portion 538 can take on a narrower form when positioned in the incision and then spring back into its normal form, which assists in the retraction of the sac and tissue. The height of the flange 532 and the central portion 538 is approximately 0.5 to 2.0 inches (1.27 to 5.08 cm), and the shield 530 is made of HDPE, LDPE, HYTREL® or other suitable polymer or metal. Furthermore, the shield 530 should preferably have three or more fingers 544.

[0094] Next, referring to Figures 87 to 90, the shredding system 600 is shown. The shredding system 600 is an instrument that allows for the safe and complete removal of body tissue or organs through a restricted surgical opening. The shredding system 600 is a substantially closed system that prevents contamination of surrounding tissue by potentially cancerous cells present in the target tissue during the shredding and extraction procedure. The shredding system 600 includes a shredder 602, a containment bag (not shown), a support hook 606, and a shield 608.

[0095] The containment bag may be any of the bag embodiments described herein. Generally speaking, the containment bag has a polymer pouch with a mouth or opening attached to a ring, the ring surrounding the mouth or opening. The ring is flexible and configured to be biased into an open state, so that the mouth of the bag is held open by the ring to facilitate insertion of a specimen into the bag. The ring is flexible so that it can be compressed into a low-profile state, thereby allowing the ring to be easily inserted into a wound or body opening. The ring maintains an open state, thereby allowing the bag to be retracted by rotating the ring itself and wrapping the side wall of the bag around the ring. A tether is attached to the ring or the proximal end of the bag. The tether has an attached tag that can be grasped with surgical instruments.

[0096] The shredding system 600 further includes a shredder 602. The shredder 602 is an electrically operated shredder. The shredder 602 has a cutting ring or annular blade 610 with a sharp distal end for cutting tissue. The annular blade 610 is mounted on a hollow cylinder 612. The cylinder 612 is connected by gears to a pneumatic or electric motor (not shown) and is configured to rotate about its longitudinal axis. The shredder 602 has an inner cylinder 614 with a trumpet-shaped or funnel-shaped proximal end connected to a shredder housing 616. The distal end 620 of the inner cylinder 614 extends to the proximal side of the annular blade 610. The inner cylinder 614 constitutes the working channel or central lumen 618 of the shredder 602. The inner cylinder 614 prevents tissue drawn into the central channel 618 from rotating within the shredder 602. The shredder 602 further comprises an outer cylinder 622. The outer cylinder 622 coaxially surrounds the cutting cylinder 612. The outer cylinder 622 has a proximal end that is connected to or forms part of the housing 616. The distal end 624 of the outer cylinder extends to a location proximal to the distal end of the blade 610. The outer cylinder 622 has an extension 626 located at the distal end 624 of the outer cylinder 622. The extension 626 extends slightly beyond the distal end of the blade 610. The extension 626 prevents core removal of the shredded specimen.

[0097] The shredding system 600 further includes a shield 608. The shield 608 may be any of the shields described herein, and in one modification, it may be the shield described with reference to Figures 51-53 and 71-86. The shield 608 has an overall spiral shape when viewed in a vertically expanded form. The shield 608 can be flattened into a low-profile unexpanded form. The shield 608 can be repeatedly moved from an expanded form to an unexpanded form and from an unexpanded form to an expanded form as needed. The shield 608 is a band of soft plastic that is spiral-shaped in its expanded form. The shield 608 may be made of a thin soft metal or other suitable material that prevents sharp objects from penetrating the shield 608. The band extends between a first end and a second end and between a apex or proximal end 628 and a base or distal end 630. The distance between the proximal end 628 and the distal end 630 is approximately the entire length 638 of the shield 608 when it is in its non-expanded or low-profile configuration. The shield 608 has an inner surface 632 and an outer surface 634 connected to each other by the proximal end 628 and the distal end 630, as well as a first end and a second end. The outer surface 634 is concave, and the inner surface 632 forms an isomorphic surface that is convex when viewed from inside the shield 608. The outer surface 634 is substantially parallel to the inner surface 632. The shield 608 is equipped with a central lumen 636. When in its low-profile non-expanded configuration, the size of the shield 608 can be laterally reduced so that it has a relatively small lateral dimension. As described above, the shield 608 has a relaxed normal position with a first lateral or diametrical dimension when it is in its low-profile non-expanded configuration. The shield 608 also has a reduced configuration when it is in its low-profile non-expanded configuration with a second lateral or diametrical dimension. The second lateral or diametrical dimension is smaller than the first lateral or diametrical dimension. The reduced form when in the non-expanded configuration is achieved by curling the shield 608 over itself to create a compact and smaller form. This curling action reduces the size of the central lumen 636. This reduced form is held in a fixed position by hand or by a lock.Insertion of the shield 608 into a small incision or body opening is greatly facilitated by curling the shield 608 over itself into a reduced form. Once inserted into the incision or body opening, the shield 608 unwinds and expands from a tightly curled state toward a relaxed, normal position with a large lateral dimension. However, forces from the surrounding tissue can prevent the shield 608 from reaching a first lateral or diametrical dimension, and thus the shield 608 can reach a dimension equal to or equal to the second lateral dimension, or have any dimension between the first and second lateral dimensions. Furthermore, the shield 608 can expand into an enlarged form with a third lateral or diametrical dimension, the third lateral or diametrical dimension being greater than the first lateral or diametrical dimension. The enlarged form can be locked in place by any of the locks described herein, which fix the position and / or lateral or diametrical dimension of the shield 608. This enlarged form can serve to retract tissue and enlarge the opening of a body or wound. The reduced form, the relaxed normal form, and any position between the reduced and enlarged forms can serve to retract tissue and hold the wound and body orifice open while providing a working channel through the central lumen 636.

[0098] Referring particularly to Figures 87 and 88, the shredder 602 is shown inserted into the central lumen 636 of the shield 608. The distal end of the shredder housing 616 abuts against the proximal end 628 of the shield 608. The length 640 of the shredder 602, which extends downward from the housing 616 and has a blade cylinder 612, an inner cylinder 614, and an outer cylinder 622, is approximately equal to the length 638 of the shield 608. In one modification, the length portion 638 of the shield 608 is shorter than the extension portion 626 protruding from the outer cylinder 622. Figure 87 shows the extension portion 626 extending beyond the length of the shield 608. In this modification, the distal end of the shield 608 is located immediately proximal to the extension portion 626. In another modification, the length portion 638 of the shield 608 is equal to the distal end of the annular blade 610. In another modification, the length portion 638 of the shield 608 extends slightly distally beyond the blade 610. In yet another modification, the length portion 638 of the shield 608 is located distal to the extension portion 626. The length portion 638 of the shield 608 is positioned to surround the hanging portion of the shredder 602, particularly the blade 610. By surrounding the blade 610, the shield 608 protects the blade 610 from accidental contact with the surrounding tissue and containment bag.

[0099] For use, the tissue containment bag is placed through a small incision in the abdomen or a small body opening or port. This is achieved by compressing the bag's flexible ring to a low-profile shape and then inserting the bag through the small incision / opening. The flexible ring opens in the body cavity by spring action, expanding the opening of the bag and making it easier to place the severed target tissue fragment into the bag. Place the target tissue into the bag while the bag is located in the body's abdominal cavity. It is best to use a retractor and place it within the incision. Next, use the bag's tether to pull the bag's ring through the incision. Roll the bag's ring itself to wrap the bag's sidewall around the ring, thereby reducing the bag's length and size, and thereby drawing the specimen inside the bag towards the incision / opening. Visualize the specimen inside the bag with the naked eye near the opening of the bag. Minimize the size of the Shield 608 by rolling or curling it into a compact shape while it is outside the patient's body. While in its reduced form, the shield 608 is placed in a pouch within the incision / opening, and the shield expands itself or expands diametrically to reverse the rotation of the shield 608 and maximize the incision / opening. The expanded position is preferably secured by a lock of the type described herein. The shield 608 is stretched to its larger dimensions. The C-shaped outer surface 634 of the shield 608 is well fixed within the incision, thereby fitting the abdominal wall into the "C" recess. The support hook 606 is advanced through the central lumen 618 of the shredder 602 and used to grasp the target tissue while visualizing the target tissue with the naked eye. Once the tissue is properly grasped, the tissue is held by the support hook 606, and the shredder 602 is moved or slid downward along the length of the support hook 606 so that the hanging portion of the shredder 602, including the blade cylinder 612, inner cylinder 614, and outer cylinder 622, passes through the central lumen 636 of the shield 608, until the distal end of the shredder housing 616 contacts the proximal end 628 of the shield 608. It is preferable to pull the support hook 606 proximal so that the specimen comes into contact with the blade 610 of the shredder 602. The shredder 602 is activated to rotate the blade cylinder 612 at high speed. With the specimen still grasped, the support hook is pulled proximal.The grasped tissue is drawn into the cutting blade of the shredder 602 using a support hook. The extension 626 of the outer cylinder 622 prevents the entire periphery of the blade 610 from simultaneously cutting through the tissue. This prevents core removal and allows the blade 610 to move along the specimen, resulting in the majority of the specimen being removed as a single unit. After all of the tissue has been removed or reduced to pieces of a size that can pass through it while fitted into the incision, the shield 608 and bag are removed. The shield 608 advantageously protects and retracts adjacent tissue at the incision site, protecting adjacent portions of the containment bag from accidental contact with the cutting blade 610. The invention also avoids creating a secondary opening in the containment bag for inserting a scope to visualize the shredding procedure. A secondary opening that could impair the closed containment system is advantageously avoided by this shredding system 600. Intracavitary shredding may scatter potentially harmful fragments of the specimen during shredding. Therefore, shredding within a closed system is desirable. A closed system is created by placing the specimen in a containment bag, allowing the bag's opening to reach the surface through an incision, thereby isolating the specimen within the bag and preventing contact with tissue in the body cavity. Conventional solutions for visualization require creating another opening in the bag and inserting a laparoscope through this opening, thus compromising the closed system. A variation involves inserting the scope through the same incision as the shredder, resulting in poor visibility and triangulation necessary for optimal observation. The shield 608 advantageously allows the use of a cutting mechanism, including a motorized shredder, within a closed system while preventing potential rupture to the contained system. The shredding system 600 can provide visibility of the specimen without a laparoscope by bringing the specimen to the surface when the bag is retracted. The shredding system 600 maintains and ensures a closed system throughout the shredding procedure by reducing damage to the tissue containment bag through the use of the shield 608 with a corresponding short shredder. The length of the shield 608 is approximately equal to the length of the protruding portion of the shredder 602. The shield 608 surrounds the blade 610, and this shield is located between the bag and the shredder 602.The shield 608 opens, and this shield holds the incision opening, allowing for easy visualization and removal of the specimen. The shield 608 protects the bag and tissue at the incision site from damage by the cutting blade 610 or support hook 606. The outer cylinder 622 of the shredder is surrounded by the shield 608, which prevents accidental contact between the containment bag and the blade 610, which could result in a breach of the closure system. The shield 608 forms a protective cage around the blade, ensuring safe shredding. In one modification, the length 638 of the non-expanded shield 608 is approximately 1 inch (2.54 cm), and the length 640 of the shredder cylinder is also approximately 1 inch (2.54 cm).

[0100] Referring next to Figures 89 and 90, a shredding system 600 using an energy-utilizing shredder 602 is shown. The energy-utilizing shredding system utilizes a tissue containment bag, support hooks, and a shield 608 in the same manner as described above. Rather than rotating the blade 610 to cut the tissue, the circular blade 610 remains stationary. The blade 610 and cylindrical body 612 of the shredder 602 are connected to the output of a unipolar energy system 652 via an energy input 650. The support hook 606 is connected to a plug 654 that leads to ground on the unipolar energy system 652. Once the target tissue is grasped by the support hook 606 and brought to the blade 610, unipolar energy is applied to cut the tissue. An extension 626 serves to achieve the same purpose as described above. An exhaust port 656 is provided in the housing 616 to prevent the inhalation of smoke from the cutting process.

[0101] Next, referring to Figures 91 to 103, a shield 700 is shown as to be positioned within the vaginal canal. The shield 700 has a shape substantially identical to the shield described herein. The shield 700 is substantially cylindrical / tubular in shape and is made of a band of material having an inner first end 702 and an outer second end 704 connected to each other between a proximal end 706 and a distal end 708. The shield 700 has an outer surface 710 and an inner surface 712. The inner surface 712 defines a central lumen 714 extending from the proximal end 706 along the longitudinal axis to the distal end 708. The central lumen 714 is shown as having a circular shape, but in other modifications it may be elliptical or elongated oval or oblong in shape. The proximal end 706 is provided with a radially outward-extending proximal flange 716 that forms a funnel-shaped entrance passage to the central lumen 714. The outer surface 634 is concave and gradually widens radially outward in a trumpet shape toward the distal end 708. At least a portion of the shield 700 overlaps itself when in its relaxed, normal form. By curling the shield 700 itself, the lateral dimension can be reduced to facilitate insertion into the vagina or other body or wound incision. The overlapping portions of the shield 700 are isomorphic and interlocking with each other. The shield 700 is configured to slide with one end, for example, the first end 702, in contact with the second end 704. The shield 700 may have a first reduced lateral or diametrical dimension suitable for easy insertion into the vagina or other body orifice. The reduced lateral position is achieved by curling the shield 700 itself to tighten and reduce its size. The shield 700 has a relaxed, normal position with a second lateral or diametrical dimension. The second lateral or diametrical dimension is larger than the first lateral / diametrical dimension. The shield 700 is molded with a bias toward its normal relaxed position, and when the shield 700 is reduced to a first diametrical position, it automatically expands or springs open or spreads toward its relaxed and normal position having substantially a second lateral or diametrical dimension.The shield 700 is preferably provided with locks of the type described herein for fixing a lateral or diametrical position. The shield 700 further has an expanded form having a third lateral or diametrical dimension, the third lateral or diametrical dimension being greater than the second lateral or diametrical dimension. The expanded form is achieved by curling the shield 700 in the opposite direction or by spreading the shield 700 to open the central lumen 714. Any of the lateral positional and intermediate positions of the shield 700 can be locked in place by the locks. The shield 700 and, in particular, the expanded form of the shield 700, help to retract tissue and open a body opening or wound, thereby providing a safe working channel for surgical procedures.

[0102] As can be seen in Figures 93 and 94, the first end 702 and the second end 704 each have an S-shaped curved portion that overlaps the outer surface 710 of the adjacent shield portion. The S-shape transitions into notches 718 and 720 near the proximal end 706 and the distal end 708, respectively. The notches 718 and 720 form a lock configured to fix the lateral dimensions of the shield 700. The notches 718 and 720 are shown in the unlocked position in Figures 93 and 94 and in the locked position in Figures 97 and 98. The notches 718 and 720 form finger-shaped extensions configured to interlock with each other to lock the shield 700 in place. In Figures 97 and 98, the finger-shaped extension located near the notch 718 of the outer second end 704 overlaps with the inner first end 702 to lock the shield 700. As described above, the outer surface 710 of the shield 700 forms a concave surface having an inflection point 722 as seen in Figures 93 and 94. The inflection point 722 is located near the proximal flange 716 above a midplane taken perpendicular to the longitudinal axis. The proximal flange 716 serves as a protective surface that protects the containment sac, retractor 724 and vaginal canal tissue at the insertion site. The shield and / or flange are made of hard, rigid, or semi-rigid, plastic or cut-resistant material. The proximal flange 716, in particular the inner surface 712 of the proximal flange 716, provides a plate-like surface that can be advantageously used to cut and reduce the target tissue for removal and extraction while it is in contact with this cutting plate surface, without risk of cutting the containment sac, adjacent tissue or retractor.

[0103] Next, referring particularly to Figures 99 to 103, a shield 700 used in combination with the retractor 724 is shown. The retractor 724 is the same retractor 62 described with reference to Figures 18 and 19. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible side wall 730. The side wall 730 defines a central opening extending along the longitudinal axis of the retractor 724. The second ring 728 can be compressed and inserted into the vaginal canal, where it expands to form a means of fixation to the vagina. The first ring 726 is located outside the patient's body above the vaginal opening, and at this opening, the first ring can be rotated and lowered to retract and expand the vaginal canal.

[0104] In a hysterectomy, the uterus is separated from the body using instruments inserted through an abdominal port. After the uterus is separated, it is preferable to insert the shield 700 directly into the vaginal canal. In this configuration, the shield 700 is curled into a reduced form, thereby facilitating its insertion. When in position, the shield 700 expands to its normal relaxed form while positioned within the vaginal canal, thereby expanding and retracting the vaginal opening. The proximal flange 716 is located near the vaginal opening. It is preferable to grasp the separated uterus and pull it into the central lumen 714 of the shield 700, and then, with the uterus pressed against this shield, finely chop it with a blade, thereby reducing the size of the uterus or cutting it into several small pieces, which can then be completely removed through the vaginal canal.

[0105] In another configuration, the containment bag is placed into the abdominal cavity through either an abdominal port or the vaginal canal. The removed uterus is placed into the containment bag. The tether of the containment bag is passed through the vaginal canal and pulled. The ring of the containment bag is compressed into a low-profile form, thereby facilitating the pulling of the proximal end of the containment bag through the vaginal canal. The ring of the containment bag is pulled out of the body, and this ring is expanded into an open form, thereby opening the mouth of the containment bag. The ring of the containment bag is located outside the vaginal opening. It is preferable to rotate the ring of the containment bag downwards, wrapping the side wall of the bag around the ring of the containment bag. This action brings the removed uterus in the bag closer to the vaginal opening. Next, the shield 700 is inserted into the mouth of the containment bag and into the vaginal canal. The shield 700 is curled downwards into a compact form, thereby assisting insertion. The proximal flange 716 is located at or near the vaginal opening. In one configuration, the proximal flange 716 of the shield 700 is snapped under the ring of the containment bag. It is best to grasp the removed uterus with a gripper and pull it into the central lumen 714 of the Shield 700, where you can begin the shredding process.

[0106] The distal end of the shield 700 is funnel-shaped, having a radial dimension that gradually increases radially from the inflection point 722 toward the distal end 708 of the shield 700. This funnel shape advantageously helps to move the detached uterus into the shield 700. The uterus is then shredded with a blade while it is at least partially positioned within the shield 700, and subsequently removed completely, either whole or in parts. The shield 700 advantageously protects the surrounding vaginal canal and containment bag from sharp blades, thereby helping to maintain the integrity of the containment bag and the closure shredding system.

[0107] In another configuration, the same procedure is performed as described in the previous paragraph, but after the uterus is placed in the containment bag and the ring of the containment bag is withdrawn from the body, the retractor 724 is inserted into the mouth of the containment bag. The second ring 728 of the retractor 724 is compressed to facilitate insertion into the mouth of the containment bag, and this second ring is then expanded into an open configuration within the containment bag at the distal end of the vaginal canal in the abdominal cavity. The first ring 726 of the retractor 724, which is located outside the body, is rotated by itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action not only retracts the vaginal canal but also retracts the containment bag so that it is not in the way, thereby moving the vaginal canal aside so that the shield 700 can be inserted. The containment bag is captured between the retractor and the vaginal canal to keep it in place and prevent it from entering or leaving the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724, which is located inside the containment bag. It is preferable to curl the shield 700 downward if necessary to make it compact, so that the shield expands and self-fixes itself in place. Next, the shield 700 is connected to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726 as shown in Figures 99 to 103. Next, it is preferable to grasp the uterus with surgical instruments and pull it out of the containment pouch and pull it into the central lumen 714 of the shield 700, where the uterus is shredded with a blade while it is at least partially positioned within the shield 700, and then completely removed, either whole or in parts. The shield 700 advantageously protects the surrounding vaginal canal and containment pouch from sharp blades, thereby helping to maintain the integrity of the containment pouch and the closed shredding system, while providing the surgeon with a mechanism to perform shredding safely and quickly.

[0108] In another variation, the same procedure is performed in the same manner as described in the paragraph above, except that the retractor 724 is placed in the vaginal canal, and then the storage bag containing the specimen is passed through the vaginal canal and pulled. In this configuration, the removed uterus is placed in the storage bag located in the abdominal cavity, and the tether attached to the proximal end of the storage bag is passed through the central lumen of the retractor using a gripper and pulled, bringing the ring and opening of the storage bag outside the patient's body. Next, it is preferable to lower the ring of the storage bag while rotating it itself to bring the detached uterus closer to the opening. Then, the flexible retractor 724 is curled itself into a compact form, and then the size of the shield 700 is reduced laterally by releasing the shield 700, thereby causing the shield to expand due to its bias, thereby causing the shield to expand laterally from its compact form. When the shield 700 expands, it self-fixes and retracts the storage bag, thereby creating a working channel in the central lumen 714 of the shield 700 for removing and shredding the detached uterus. It is preferable to snap the proximal flange 716 of the shield 700 under the ring of the containment bag or the first ring 726 of the retractor 724. The containment bag is trapped between the retractor 724 and the shield 700, preventing it from slipping proximal or distal during the procedure. The flange 716 can serve as the cutting surface, and a sharp blade can be used to cut against this cutting surface for central removal. For all of the above hysterectomy procedures, the containment bag and retractor combination shown in Figure 20 can be used in place of one or more of the containment bag and retractor 724.

[0109] In yet another configuration, the shield 700 is used in conjunction with a retractor 724, as shown in Figures 99 to 103. In this configuration, the retractor 724 is positioned within the vaginal canal. The uterus is dissected using standard techniques either before or after positioning the retractor 724. The second ring 728 of the retractor 724 is compressed to allow for easy insertion into the vaginal canal, and then this second ring expands in the abdominal cavity at the distal end of the vaginal canal to become open. The first ring 726 of the retractor 724, which is located outside the body, rotates itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action retracts the vaginal canal. Next, the shield 700 is inserted into the central lumen of the retractor 724. The shield 700 is curled downward if necessary to make it compact, so that the shield 700 can expand and self-fix itself in place. Next, the shield 700 is connected to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726 as shown in Figures 99 to 103. The uterus is then preferably grasped with surgical instruments and pulled into the central lumen 714 of the shield 700, where it is shredded with a blade while at least partially positioned within the shield 700, and then completely removed, either whole or in parts. The shield 700 advantageously provides the surgeon with a mechanism for safe and rapid shredding while protecting the surrounding vaginal canal and the retractor 724 from sharp blades.

[0110] Next, referring to Figures 104 to 107, another form of shield 800 used in the vaginal canal is shown. The shield 800 has an apical end 802 and a basal end 804 connected to each other by a side wall 806. An opening 808 is formed in the shield 800, extending through the apical end 802 and the basal end 804. The shield 800 further has a first flange 810 and a second flange 812. The first flange 810 extends distally from the basal end 804. The first flange 810 is curved and forms a concave elongated surface toward the longitudinal axis 816. The first flange 810 is also preferably a substantially flat elongated surface. The first flange 810 has a distal end 814 that is inclined away from the longitudinal axis 816. The second flange 812 extends distally from the basal end 804. The second flange 812 has a hook 818 configured to be attached to the ring of the containment bag or the proximal ring of the retractor by snapping it under the ring. Figures 106 and 107 show the shield 800 connected to the retractor 724. The retractor 724 is the same retractor described above with reference to Figures 18 and 19 and Figures 99 to 103. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible side wall 730. The side wall 730 forms a central opening extending along the longitudinal axis of the retractor 724. It is preferable to compress the second ring 728 and insert it through the vaginal canal, where the second ring expands to become a means of fixation to the vaginal canal. The first ring 726 is located outside the patient's body above the vaginal opening, where the vaginal canal can be retracted and expanded by rotating the first ring downward.

[0111] Next, the use of Shield 800 in surgical procedures, such as hysterectomy, will be described. However, the present invention is not limited to use in hysterectomy and can be used in any target tissue extraction or shredding procedure. In hysterectomy, the uterus is separated from the body by instruments inserted through an abdominal port.

[0112] In one embodiment, the shield 800 is used in conjunction with the retractor 724 shown in Figures 106 and 107. In this embodiment, the retractor 724 is positioned in the vaginal canal. The uterus is dissected using standard techniques either before or after positioning the retractor 724. The second ring 728 of the retractor 724 is compressed to allow for easy insertion into the vaginal canal, and then this second ring expands in the abdominal cavity at the distal end of the vaginal canal to become open. The first ring 726 of the retractor 724 is located outside the body and rotates itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action retracts the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 and connected to the retractor 724. The shield 800 is connected to the first ring 726 of the retractor 724 by snapping the second flange 812 of the shield 800 under the first ring 726 from the inside of the first ring 726, as shown in Figures 106 and 107. It is preferable that additional hooks be provided to connect the shield 800 to the retractor 724. The shield 800 covers or overlaps the first ring 726 of the retractor 724, and one or more hooks 818 hook under the first ring 726 to secure the shield 800 to the retractor 724. It is preferable that the uterus is then grasped with surgical instruments and pulled in a proximal direction, and positioned on or alongside the first flange 810. The first flange 810 of the shield 800 is curved, which advantageously supports the detached uterus, thereby preventing it from sliding off the first flange 810, while reducing its size so that the surgeon can cut it with a blade and remove it through the vaginal canal. The first flange 810 also advantageously acts as a cutting surface, allowing the blade to safely cut tissue located near or in contact with the first flange 810 while keeping it against the cutting surface. The inclined distal end 814 of the first flange 810 serves as an additional vaginal dilation means and as a ramp or inclined path for moving and guiding the uterus into the vaginal canal and proximal toward the vaginal opening.At the proximal end of the shield 800, the ring-shaped portion of the shield 800 advantageously safely retracts the lip out of the way of the shredding blade. The uterus is shredded with the blade while at least partially positioned within the shield 800, and then completely removed, either whole or in parts. The shield 800 advantageously protects the surrounding vaginal canal, lip, and retractor 724 from the sharp blade, while providing the surgeon with a mechanism to perform shredding safely and quickly.

[0113] In another configuration, the containment bag is placed in the abdominal cavity through either an abdominal port or a vaginal canal. The removed uterus is placed into the containment bag. The tether of the containment bag is passed through the vaginal canal and pulled. The ring of the containment bag is compressed into a low-profile configuration, thereby facilitating the pulling of the proximal end of the containment bag through the vaginal canal. The ring of the containment bag is pulled out of the body, and this ring is expanded into an open configuration, thereby opening the mouth of the containment bag. The ring of the containment bag is located outside the vaginal opening. It is preferable to rotate the ring of the containment bag as it is lowered, wrapping the side wall of the bag around the ring of the containment bag. This action brings the removed uterus in the bag closer to the vaginal opening. The shield 800 is inserted into the mouth of the containment bag and into the vaginal canal, and connected to the ring of the containment bag by hooking the second flange 812 onto the ring and securing the shield 800 to the containment bag. The removed uterus in the containment bag is grasped with a gripper and pulled onto the first flange 810 of the shield 800. The inclined distal end 814 of the first flange 810 helps guide the uterus in an inclined position and supports it to be held for shredding. With the uterus positioned at least partially adjacent to the first flange 810, the uterus is shredded with the blade and then completely removed, either whole or in parts. The shield 800 advantageously protects the surrounding vaginal canal and containment bag from the sharp blade, thereby helping to maintain the integrity of the containment bag and the closed shredding system.

[0114] In another configuration, the same procedure is performed as described in the paragraph above, but after the uterus is placed in the containment bag and the ring of the containment bag is withdrawn from the body, the retractor 724 is inserted into the mouth of the containment bag. The second ring 728 of the retractor 724 is compressed to allow for easy insertion into the mouth of the containment bag, and this second ring is then expanded in the containment bag at the distal end of the vaginal canal in the abdominal cavity to become open. The first ring 726 of the retractor 724 is rotated by itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action not only retracts the vaginal canal but also retracts the containment bag so that it is not in the way, thereby moving the vaginal canal aside so that the shield 800 can be inserted. This captures the containment bag between the retractor 724 and the vaginal canal, keeping the containment bag in place and preventing it from entering or leaving the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 located inside the containment bag. The shield 800 is connected to the first ring 726 of the retractor 724 by snapping the proximal flange 812 of the shield 800 under the first ring 726 of the retractor 724. The uterus is then grasped with surgical instruments and pulled out of the containment pouch so that it is positioned alongside the first flange 810 of the shield 800, and while the uterus is at least partially in contact with the first flange 810, it is shredded with a blade and then completely removed, either whole or in parts. The shield 800 advantageously protects the surrounding vaginal canal, as well as the containment pouch and retractor 724, from sharp blades, thereby helping to maintain the integrity of the containment pouch and the closed shredding system, while providing the surgeon with a mechanism to perform shredding safely and quickly. In relation to all of the hysterectomy procedures described above, the containment pouch and retractor combination of Figure 20 can be used in place of one or more of the containment pouch and retractor 724. Furthermore, as can be understood, the present invention is not limited to hysterectomy procedures, but can be used for the cutting, segmentation, and removal of any tissue or organ.

[0115] Referring next to Figures 108 and 109, a modified shield 900 is shown, having a funnel 902 with a retraction finger 904 at its distal end. The funnel 902 defines a central opening 906. The proximal end of the shield 900 forms a funnel-shaped entrance to the central opening and forms a proximal flange surface that circumferentially surrounds the central opening 906. The shield 900 is inserted into the body or wound incision by first inserting the retraction finger 904 and then inserting or tilting the central portion of the funnel 902 into the opening. The proximal end of the funnel 902 is placed on the top of the abdominal or other outer surface of the body. The proximal flange becomes the cutting plate placement site, where tissue can be shredded. The retraction finger 904 helps to retract the incision or body orifice and helps to keep the shield 900 fixed in place. The retraction finger 904 forms a distal flange that extends only around a portion of the periphery of the distal end of the central opening 906. The retraction finger 904 is curved such that the lateral contour of the shield 900 at the location of the retraction finger 904 is substantially C-shaped, in which case the upper part of the letter "C" extends a long distance laterally relative to the lower part of the "C". The funnel 902, when used in conjunction with the shield 900, also provides protection to the surrounding tissue, as well as to the containment bag and retractor. For example, the containment bag is inserted through a body opening or incision, and after the specimen is placed in the bag, the opening of the containment bag is pulled back from the incision. The proximal end of the containment bag is placed on the abdomen, and the shield 900 is inserted into the opening of the containment bag and secured with the retraction finger 904. The gripper is inserted into the central opening 906, and the specimen in the containment bag is pulled toward the central opening 906. Next, the specimen is divided using a blade so that it can be removed whole or in parts through a small incision / body opening. The Shield 900 is made of a firm, sturdy plastic that is thick enough to prevent and reduce the possibility of penetration by the blade, while also protecting adjacent tissue and maintaining the integrity of the containment bag.

[0116] In another embodiment, the shield 900 is used with the same retractor as described above. The retractor is placed in the incision either before or after the bag is positioned, and then the shield 900 is inserted into the opening of the containment bag and the retractor. In one embodiment, the proximal end of the shield 900 is sized and shaped to fit with the proximal ring of the containment bag or retractor by covering or snapping onto the proximal ring of the containment bag or retractor. One embodiment of the shield 900 that fits over the proximal ring of the retractor or containment bag is shown in Figures 109B and 109C, with an oval central lumen 906 and a circular central lumen 906, respectively. The shield 900 in Figures 109B and 109C has at least one hook 905 configured to be attachable to the ring of the retractor or containment bag.

[0117] Next, referring particularly to Figure 109, the funnel 902 has a circumferential rim 908 that rises from the inner surface. The rim 908 is configured to connect to a blade, which will be described in detail below. The funnel 902 also has a raised portion 910. The raised portion 910 is configured to hold a second shield 912. The second shield 912 is shown in Figure 110. The second shield 912 is substantially the same as the shield described with reference to Figures 71 to 86, and is substantially the same as other shields described herein. In one embodiment, the second shield 912 is spiral in shape and can be flattened vertically and expanded as described above. In the embodiment shown in Figure 110, the second shield 912 is not spiral but substantially cylindrical with a concave outer surface and gaps 914 to form a C-shaped shield. The second shield 912 has a proximal flange 916 and a distal flange 918 connected to each other by a central portion 920. The proximal flange 916 is preferably equipped with a tab or finger pull to assist in its removal from the body orifice / incision. The second shield 912 has a reduced form with smaller lateral dimensions than the normal relaxed form shown in Figure 110. The reduced form is ideal for insertion into the wound or body orifice and for connecting the second shield 912 to the first shield 900. The second shield 912 is made of a soft plastic with sufficient properties to prevent penetration by blades or other sharp objects or instruments under normal use in order to protect adjacent tissue.

[0118] Referring now to Figure 111, the first shield 900 is shown connected to the second shield 912. The C-shaped second shield 912 is positioned within the first shield 900 such that the proximal flange 916 of the second shield 912 is positioned over at least a portion of the inner surface of the funnel 902 of the first shield 900. The raised portion 910 of the shield 900 is received within the gap 914 of the second shield 912. The connection with the raised portion 910 prevents the second shield 912 from moving around within the funnel 902. The first shield 900 provides protection along a portion of the lower perimeter where the retraction finger 904 is positioned, and the second shield 912 completes the circumferential protection at the distal end. The second shield 912 provides 360° circumferential protection at the proximal end where it is positioned within the incision / body opening. Furthermore, the distal flange 918 provides a funnel-shaped inlet into the central lumen 922 of the second shield 912, which helps to move tissue into and out of the shields 900,912 while providing protection for the surrounding tissue, containment bag, and retractor, if used. The shields 900,912 are preferably used with a manual blade shredder or with the same short electric shredder described above with reference to Figures 87-90.

[0119] Next, referring to Figures 112 and 113, a blade carrier 926 is shown connected to a first shield 900, which is connected to a second shield 912 to constitute another form of the shield system. The blade carrier 926 has a funnel 928 defining a central opening 930, a blade receiver 932, and a blade 934. The funnel 928 has a funnel shape and a circumferential hook configured to overlap the first shield 900, snap onto it, and connect to it. Specifically, as shown in Figure 113, the circumferential hook of the funnel 928 is directly connected to a raised circumferential rim 908. In one embodiment, the blade carrier 926 snaps onto the first shield 900 so that it rotates relative to the first shield 900, although it is held vertically. The blade receiver 932 houses the blade 934 within a blade channel 936. The blade 934 is connected to the blade handle 938 by a pin 940, which connects the blade 934 to an inner rod 942. Details of the blade housing 932 are also shown in Figures 114 and 115. In one embodiment, the inner rod 942, to which the blade 934 is pinned by the pin 940, reciprocates relative to the blade handle 938. The reciprocating motion can be provided manually by moving the inner rod 942 back and forth relative to the blade handle 938 at its proximal end, causing the blade 934 to move back and forth at its distal end. The reciprocating motion may also be provided by an electric motor (not shown) located in the blade handle 938 at its proximal end within a removable and reusable handle attachment. The blade holder 932 is preferably provided in two parts, namely a first part and a second part. The first part has a blade channel 936 with a slot 944 configured to receive a pin 940 and to guide the translation of a blade 934 within the blade channel 936.One end of pin 940 is connected to the blade 934, and the other end of pin 940 is connected to the distal end of inner rod 942, which is housed within a second portion of blade receiver 932. Together, these house the blade 934. Blade receiver 932 is connected to a funnel 928 of blade carrier 926. The inner rod 942 is moved distally to expose the blade 934 for cutting tissue when in the exposed position. With the blade 934 exposed, it is preferable to rotate the blade carrier 926 relative to the first shield 900, thereby allowing tissue to be cut circumferentially along at least a portion of the interior of the central lumen. The blade 934 can be retracted to a retracted position, in which the blade 934 is at least partially hidden within blade receiver 932. When in the retracted position, the sharp sides of the blade 934 are substantially hidden, thereby making the handling of the blade carrier 926 safer. The blade 934 can be moved manually or automatically from the retracted position to the exposed position to cut tissue. This reciprocating cutting motion can be selectively performed manually by the user or automatically when continuous reciprocating tissue cutting is desired or performed. The reciprocating cutting motion can also be performed simultaneously by the rotation of the blade carrier 926 relative to the first shield 900 or intermittently by the rotation of the blade carrier 926. By moving the blade 934 from the retracted position to the exposed position, the blade 934 moves in a plane containing the distal end of the central opening 930, either at an angle to this plane or substantially perpendicular to this plane. This plane can also be defined as a plane perpendicular to the longitudinal axis of the instrument or the longitudinal axis of the central lumen. The amount of blade 934 exposed is selectable by the user, thereby allowing selective cutting. For example, the blade 934 can be exposed from the fully retracted position to a partial position, in which case the blade 934 cannot cross the plane containing the distal end of the central opening 930.The blade 934 is configured to extend beyond the distal end of the central opening 930 of the blade carrier 926, but not beyond the distal end of the second shield 912, so that the blade 934 and the blade path are always surrounded and enclosed by one or more of the first shield 900, the second shield 912, and the blade carrier 926. In another embodiment, the distal end of the blade 934 may extend slightly beyond the distal end of the second shield 912.

[0120] In one embodiment, the blade 934 is fixed to the blade holder 932, and this blade does not reciprocate relative to the blade carrier 926, but only rotates relative to the first shield 900. In another embodiment, the blade carrier 926 is fixed to the first shield 900 in the sense that it does not rotate relative to the first shield 900, but the blade carrier is configured so that the blade 934 reciprocates relative to the blade carrier 926. The rotational cutting motion is intended to increase the opportunity to remove the specimen as a single extract rather than a number of small pieces, while ensuring protection from surrounding tissue. The blade 934 is also illustrated to curve downward into the central opening. In another embodiment, the blade 934 extends radially inward in a plane perpendicular to the central lumen, and this blade has a form similar to a guillotine or cigar cutter. The blade 934 having an approach angle between 0° and less than 180° is within the scope of the present invention. An approach angle of zero means that the blade 934 crosses a plane perpendicular to the longitudinal axis of the central lumen, parallel to the longitudinal axis, at the 12 o'clock position. An approach angle of less than 180° means that the blade 934 crosses a plane perpendicular to the longitudinal axis when viewed from below that plane, at approximately the 5 o'clock and 7 o'clock positions.

[0121] Figure 116 shows the blade 934 of the blade carrier 926. The blade 934 has a sharp tip and sharp sides configured to penetrate and cut tissue.

[0122] Referring next to Figures 117–119, a shield assembly 950 is shown, which includes a blade carrier 926, a first shield 900, and a second shield 912. The blade 934 is shown coupled to a blade handle 938 having a motor housed in a removable handle extension 946. The first shield 900 has a notch 948, which is visible in Figures 109, 111, 117, and 118. The notch 948 facilitates the separation and removal of the blade carrier 926 from the first shield 900 by providing a place for the blade carrier 926 to be snapped away from the first shield 900 with a finger.

[0123] Next, referring to Figures 120 to 126, another configuration of the shield assembly is shown. The shield assembly includes a first shield 900, a second shield 912, and a blade carrier 926. The blade carrier 926 has a blade receiver in the form of two parts 932a, 932b, a blade 934, an inner rod 942, a pin 940, and a blade handle 938. The length of the blade handle 938 is not shown to scale and is depicted for illustrative purposes to include a modification in which a reusable handle extension 946 can be attached to the proximal end of the blade handle 938 in an example configuration in which the shield assembly is disposable. The modifications in Figures 120 to 126 are substantially identical to the configurations shown in Figures 109 to 119 with some modifications. The second shield 912 is not a cutting cylinder but has the spiral properties described above. The second shield 912 is shown in a compression type pair in Figure 120. The first shield 900 has an outer rim 908 provided around the top of the first shield 900. The funnel 928 of the blade carrier 926 is snap-on below the outer rim 908 in the configuration shown in Figures 120 to 126.

[0124] In another form of the shield, it is formed around a helical surface whose cross-section perpendicular to the helical guide path is a parabola. Once removed, the helical surface compresses itself into a suspension surface, and the shield is located within this suspension surface during its resting state. The following auxiliary equations cover variations of the shield.

[0125] x(u,v)=β[cos(α)sinh(v)sin(u)+sin(α)cosh(v)cos(u)] (1)

[0126] y(u,v)=γ[-cos(α)sinh(v)cos(u)+sin(α)cosh(v)sin(u)](2)

[0127] z(u,v)=δ[ucos(α)+vsin(α)](3)

[0128] The value α is a constant fixed parameter that changes the progression state during the deformation of a helical surface into a catenary surface. When α=0, a helical surface is generated, and when α=π / 2, a catenary surface is generated. Variations of the shield are α values ​​greater than 0 and less than π / 2, which are considered to lie on the open interval (0,π / 2). Other variations of the shield have α values ​​greater than 0 and less than or equal to π / 2, which are considered to lie on the open interval (0,π / 2). Other variations of the shield have α values ​​greater than or equal to 0 and less than or equal to π / 2, which are considered to lie on the open interval (0,π / 2). The parameters β,γ,δ are also constants. For β,γ,δ∈R\{0}, if β<0, γ<0, δ<0, the rotation flows counterclockwise. For any β,γ,δ>0, the rotation flows clockwise. According to the auxiliary equations, the surface is made on the u-v plane. The values ​​of vectors u and v can be considered when u ∈ (-π, +π) and v ∈ (-∞, +∞).

[0129] Referring next to Figure 127, another embodiment of the present invention of a storage bag 1000 is shown. The bag 1000 has a side wall 1002 defining an opening 1004 at its proximal end. The bag 1000 has a longitudinal axis substantially perpendicular to the opening 1004. The side wall 1002 can form any shape of the bag 1000, such as cylindrical, elongated, spherical, etc., and the side wall may or may not have a base or bottom panel as a base point from which the side wall 1002 extends toward the proximal end. The side wall 1002 may preferably extend downward to form a seamed or seamless base. For example, the bag 1000 may be formed by a length of flattened material that is folded and joined along the side, so that a seam is not formed along the base, but rather located at the side of the bag 1000 and extending upward substantially perpendicular to the longitudinal axis.

[0130] Still referring to Figure 127, the containment bag 1000 has at least a first ring 1006 located at or near the opening 1004 of the bag 1000. The first ring 1006 is connected to the bag 1000. A second ring 1008 is shown in Figure 127. The second ring 1008 is located at a distance below the first ring 1006 and is connected to the bag 1000. The first ring 1006 and the second ring 1008 are elastic and can be compressed from an expanded circular or oval shape to a flattened, elongated shape with reduced lateral dimensions suitable for entering through a small incision, body orifice, or through the lumen of a trocar. In one modification, the second ring 1008 is not used. The bag 1000 can be crushed to a short length along the longitudinal axis of the bag 1000. Next, when the second ring 1008 is used, the first ring 1006 and the second ring 1008 are crushed into their flattened, elongated forms, and then easily compressed laterally to deploy the containment bag 1000 into the abdominal cavity. In the abdominal cavity, the compressed rings 1006 and 1008 return to their original expanded, open forms. With the rings 1006 and 1008 in these expanded forms in the abdominal cavity, the bag 1000 is easily oriented within the abdominal cavity. The areas around the rings 1006 and 1008 become targets for the placement of the excised tissue or organ. In one modification, the bag 1000 in its flattened form is not facing upwards, because the specimen can be placed within the boundary of the first / second rings 1006 and 1008 using either side. The first ring 1006 serves as a periphery guide for the placement of the specimen around it, and therefore it is preferable that the first ring 1006 be brightly colored, or colored in contrast to the rest of the bag 1000 or its intended enclosing, so that the first ring can be easily observed laparoscopically. After the excised tissue or organ is placed around the first ring 1006, the first ring 1006 is moved toward the exit incision or body opening. When the ring 1006 is lifted, the excised tissue falls into or deeper into the internal space 1010 of the bag.As the bag is moved toward the exit opening, the tissue specimen becomes trapped within the internal space 1010 of the bag 1000. The first ring 1006 is compressed into a reduced, elongated form and pulled through the exit body orifice, opening, or exit incision. Once passed through the opening, the first ring 1006 expands and springs back to become an open, expanded form, positioned above or near the abdominal wall outside the patient's body, and covering the exit body orifice, opening, or exit incision. The bag 1000 is wrapped around the first ring 1006 by inverting the first ring 1006 outward or inward, thereby rotating or flipping the first ring 1006 itself. By rotating the first ring 1006 in the opposite direction, the bag 1000 can be spread apart from the first ring 1006. In one modification, the first ring 1006 has a cross-section whose length is greater than its width. The elongated cross-section of the first ring 1006 is advantageous in keeping the sidewall 1002 of the bag wrapped around the first ring 1006. If the cross-section of the first ring 1006 were circular, the first ring 1006 could easily rotate on its own or in the opposite direction, thereby allowing the sidewall 1002 to wrap around or unwrap around the first ring 1006. By rotating the first ring 1006 around itself, the bag 1000 is pulled upward, bringing the specimen inside the bag 1000 closer to the opening. Rotating the first ring 1006 around itself reduces the distance of the sidewall 1002 between the first ring 1006 and the second ring 1008, thereby bringing the second ring 1008 closer to the first ring 1006, and as a result the abdominal wall is fixed between the first ring 1006 and the second ring 1008, thereby fixing the bag 1000 to the patient for shredding. The winding action of bag 1000 reduces the volume of bag 1000, forming a taut protective apron that is well-formed around the opening and surrounding the patient's body. The winding action can also help retract the tissue at the opening, thereby conveniently enlarging the opening for easy removal of the tissue from inside bag 1000. The specimen is then removed from bag 1000 by manually cutting it with a blade or automatically cutting it with an electronic shredder to a size and shape that allows it to pass through the opening and be removed from bag 1000.After removing the tissue sample from bag 1000, the first ring 1006 is rotated in the opposite direction, widening the space between the two rings 1006 and 1008 if necessary. Thus, the second ring 1008 is compressed into its reduced, elongated form and pulled out of the patient's body through the opening, and bag 1000 is removed from the patient.

[0131] The bag 1000 and / or the sidewall 1002 of the bag 1000 are made of a material that is extremely cut-resistant to sharp objects, such as knife blades and blades used in electronic shredders. In one embodiment, the bag 1000 is made of a highly cut-resistant woven fabric such as Dyneema® fiber. The cut-resistant material is ultra-high molecular weight polyethylene (UHMWPE), also known as high-modulus polyethylene or high-performance polyethylene. In one embodiment, the bag 1000 is made of Dyneema® coated with an elastomer to prevent fluid from crossing the material plane. In one embodiment, the entire bag 1000 is made of the cut-resistant material. In another embodiment, only selected portions of the bag 1000 are made of the cut-resistant material. In one embodiment, at least a portion of the sidewall 1002 of the bag 1000 located between the first ring 1006 and the second ring 1008 is made of the cut-resistant material. In another embodiment, only a portion of the bag 1000 is made of a cut-resistant material in the area where cutting is expected. In yet another embodiment, the lower portion of the distance between the two rings 1006, 1008 is made of a cut-resistant material, and the upper portion of the distance between the two rings 1006, 1008 is used for wrapping around the first ring 1006. In yet another embodiment, the upper portion of the distance between the two rings 1006, 1008 is made of the same cut-resistant material, but has a thickness or fiber thickness smaller than the thickness of the sidewall or the fiber thickness of the lower portion. In an embodiment in which a portion of the bag 1000 is made of a cut-resistant material, the remaining portion is made of the appropriate polymer material described above. In one embodiment, using a bag 1000 made of a cut-resistant material eliminates the need for the retractor described above, which would normally be used in conjunction with the bag 1000 in the shredding procedure. Therefore, the bag 1000 advantageously provides not only cut resistance and safety shielding during shredding, but also helps retract the opening into which it is inserted. Because the bag 1000 is cut-resistant, it can be used without using the shield / guard of the type described above. By not providing a shield or guard, an advantageously large working space is obtained.

[0132] Embodiments of bag 1000 consist of sheets, membranes, fibers, and / or strands of one or more materials that provide the sheath with abrasion resistance and puncture resistance in addition to cut resistance. Suitable sheets, membranes, fibers, and / or strands consist of at least one of natural polymers, semi-synthetic polymers, synthetic polymers, metals, ceramics, glass, carbon fibers, carbon nanotubes, etc. Suitable natural fibers include cellulose and silk. Semi-synthetic fibers include nitrocellulose, cellulose acetate, and rayon. Suitable synthetic fibers include polyester, aromatic polyester, polyamide (NYLON®, DACRON®), aramid (KEVLAR®), polyimide, polyolefin, polyethylene (SPECTRA®), polyurethane, polyurea, polyvinyl chloride (PVC), polyvinylidene chloride, polyetheramide (PEBAX®), polyetherurethane (PELLETHANE®), polyacrylate, polyacrylonitrile, acrylic, polyphenylene sulfide (PPS), polylactic acid (PLA), poly(diimidazopyridinylene-dihydroxyphenylene) (M-5), poly(p-phenylene-2,6-benzobisoxazole) (ZYLON®), liquid crystal polymer fibers (VECTRAN®), etc., as well as their formulations, copolymers, composites, and mixtures. Suitable metals include stainless steel, spring steel, nitinol, superelastic materials, amorphous metal alloys, etc. The bag 1000 has a retractor assembly that provides both specimen containment and tissue retraction features. Additional retraction features, materials, and configurations incorporated into the bag 1000 in embodiments of the present invention are described in U.S. Patent Application Publication No. 2011 / 00542610(A1), which is incorporated herein by reference and whose entirety constitutes part of this specification.

[0133] Currently available tissue shredders generally cut tissue using exposed and unprotected instruments within the body cavity, such as sharp blades or energy tips. With most shredders, this introduces additional risks because the exposed blade / tip can easily come into contact with unintended areas, thereby causing damage to organs, tissues, blood vessels, etc. Because current shredders cut tissue in an open area, small pieces of the cut tissue may remain after the tissue removal procedure. These pieces can lead to endometriosis in women, where uterine cells adhere to other organs or tissue walls. These pieces may also contain cancer cells that must be completely removed. Currently, if tissue is suspected to be cancerous, the entire mass is removed openly rather than laparoscopically, increasing the risk of infection and prolonging recovery time for the patient. Even if all pieces are found, the extra step of examining the body cavity for small tissue elements still increases the surgical time. Furthermore, current shredding machines require two people to perform the procedure. One person must pass the tissue through the shredding machine with support hooks and pull it, while the other must hold the remaining tissue mass from inside the body cavity, bringing it close to the tip of the rotating blade. When this procedure is being performed, the specimen is usually dropped or torn away from the instruments that hold the specimen in place during shredding. This results in additional time, as the person responsible for positioning the specimen in front of the shredding machine must find the tissue and re-clamp the instruments to it, and then position the specimen again in front of the shredding machine. Therefore, shredding in a containment means, such as a bag, is desirable, but the bag itself is susceptible to punctures and spillage of contents. One embodiment of the specimen bag of the present invention has a protective inner layer of material that resists punctures caused by the support hook jaws and the rotating shredding machine blade. Also, since the shredding machine is locked in a stationary position by the use of any of the aforementioned stabilizers, the risk of the blade contacting the bag is greatly reduced. Using a sample bag ensures that the entire tissue sample is contained, and therefore, even if small pieces fall from a larger sample during the cutting process, these pieces will be removed when the bag is withdrawn from the patient.This increases patient safety and shortens the surgical time required for the tissue fragmentation procedure, as there is no need to search for leftover tissue fragments afterward. The specimen bag supports and holds the tissue in place, allowing one person, rather than two, to perform the fragmentation procedure. This also reduces the time required to continuously reposition and reclamp the specimen.

[0134] Referring next to Figures 128-134, the tissue shredder 3000 is a multi-component medical device used to capture tissue specimens from within the human body, such as the uterus, under laparoscopic surgical conditions and reduce the size of such specimens so that they can be removed through small incisions, body orifices, or openings. This multi-component medical device may or may not include a laparoscopic port. The shredder 3000 has a gear housing 3016 housing a gear train, as can be clearly seen in Figure 133, which is connected to a flexible transmission shaft 3018, which is connected at its proximal end to a motor for rotating the shredder blade 3010. The shredder 3000 has a central working channel lumen 3020 that extends through the length of the shredder 3000. The inner and outer tubes of the shredder 3000 are stationary and do not rotate relative to the movable blade 3010 so as not to provide a moving surface to the tissue when the tissue is being removed through the lumen 3020. In one embodiment, the shredder 3000 has a camera 3022. The camera 3022 may be formed integrally with the rest of the shredder 3000, or it may have a separate add-on that slides along the shredder shaft and is connected to the shredder 3000 as shown in Figure 134. Alternatively, as shown in Figure 132, the distal end of the shredder shaft has a fixed projection attachment that covers at least a portion of the blade extending distally to interrupt the shredding of tissue in order to prevent the tissue from rotating relative to the instrument.

[0135] Still referring to Figures 128–134, the shredding system further includes a support hook 3012 having a jaw-like gripper at the distal end, controlled at a handle 3024 located at the proximal end to open and close the jaws 3026 for grasping tissue. The shaft 3028 and jaws are configured to extend and protrude from the distal end of the shredder shaft, fitted within the working channel 3020 of the shredder 3000. The support hook handle 3024 is designed to be held vertically in either the left or right hand, and the ergonomic design means that the hand and arm are optimized for upward pulling motions. The handle 3024 has a lever 3030 that is pulled toward the handle 3024 to close the jaws 3026, as shown in Figure 129. In a variation, the lever 3030 may be pulled toward opening the jaws 3026. Lever 3030 is under spring tension so that it opens by spring action and moves away from handle 3024, which can determine the closed position of jaw 3026, thereby allowing the user to focus on pulling support hook 3012 upward to extract tissue. In a variation, the trigger is under spring tension so that lever 3030 opens jaw 3026 away from handle 3024 by spring action.

[0136] Referring particularly to Figures 130 to 132, the support hook jaw 3026 has a curved distal tip 3032. The jaw 3026 includes an upper jaw and a lower jaw that are hinged to each other. Each of the upper and lower jaws has a rounded and curved distal end that has no sharp parts whatsoever along the curve drawn by the distal end 3032 when the jaw 3026 is opened and closed. In the closed configuration shown in Figures 130 and 131, the curved distal tip 3032 has no exposed sharp parts or edges that could pose a risk to the integrity of the tissue or sac when in the open or closed configuration. The interiors of the upper and lower jaws are provided with teeth 3034. The distal tip 3032 also has interlocking teeth 3034 of the upper and lower jaws, which provide a smooth, curved outer surface to protect any surrounding tissue and / or sac while providing an active grip on the tissue in the grasped state. Figure 132 shows the jaw 3026 in an open configuration, next showing the path 3036 during opening and closing of the support hook, and then the distal end 3032. The curved distal end 3032 advantageously protects the bag being dissected from being punctured while the tissue is being grasped. Even when the jaw 3026 is fully open, the curved distal end 3032 of the jaw can protect the bag from undesirable puncture.

[0137] Referring next to Figures 135A to 135D and Figures 136A and 137B, the shredding system includes a specimen collection bag 3002. The shredding system described may be used with an electric shredder as described above, or it may be used with a manual shredding method. The bag 3002 is shown in a flattened state in Figure 135A and in a rolled-up state in Figures 135B and 135C. The bag 3002 has a bag ring 3004 that surrounds the opening or mouth of the bag 3002. Figure 136A shows a tissue specimen 3006 captured inside the bag 3002 with the bag ring 3004 pulled outwards. Figure 136B shows the bag ring 3004 pulled completely through the body opening to expose the inside of the bag 3002 to the outside of the body in order to remove the specimen 3006 inside the bag 3002. In Figure 136B, the tissue guard 200 is shown ready to be inserted into the body opening at any time. Although tissue guard 200 is specified, any tissue guard of the present invention can be used.

[0138] Referring to Figures 137A–137C and 138A–138C, another configuration of the bag 3002 is shown. The bag 3002 has a bag ring 3004 with an elongated cross-section, for example, the cross-section shown in Figure 137C. The bag 3002 in Figures 137A–137C is configured so that the side walls of the bag 3002 can be rolled down into the bag ring 3004. Figure 138A shows the bag 3002 with a tissue sample 3006 inside. The bag ring 3004 is drawn through the body opening to the body surface. Figure 138B shows the bag ring 3004 drawn completely to the surface, and Figure 138C shows the bag ring 3004 rotated or turned inside out to carry the contents of the bag to a surface where the length of the side walls of the bag can be reduced and the contents of the bag can be easily shredded, as indicated by the arrow in Figure 138C and described above in this specification. The bag ring 3004 is not limited to a ring having the cross-section shown in Figure 137C, but any cross-section that allows the bag to be wrapped around the bag ring is included in the scope of the present invention. The bag ring 3004 is flexible so that it can be crushed and compressed into an elongated shape, and as a result, the bag ring can be inserted into and removed through a small incision or body opening. The elastic bag ring 3004 expands upon release to take on an open shape that allows for easy placement of the specimen 3006 inside the bag 3002. The bag 3002 has an open top, and the semi-rigid bag ring 3004 is attached at or near the opening of the bag 3002. The bag 3002 can be deployed into the body, for example, in the abdomen, using a trocar or other deployment instrument. The bag 3002 can be manipulated with a gripper. The specimen 3006 is placed in the bag 3002, and the bag 3002 is retrieved by passing it through the body wall 3056, for example, the abdominal wall. The entire sac 3002 does not pass through the small laparoscopic incision due to the large size of the specimen 3006. The semi-rigid sac ring 3004 is the only part that reaches the surface while the rest of the sac remains in the abdominal cavity of the body. The cross-section of the semi-rigid ring is designed to allow the sac 3002 to be shortened by a rounding technique. This not only shortens the sac 3002 but also aids in wound retraction.The tissue sample 3006 acts as an anchor, enabling retraction of the wound opening, thereby allowing for high access to the tissue 3006 by an electric or manual shredding instrument. Once the bag 3002 is in position, shredding can begin. As the size of the tissue sample 3006 decreases, the semi-rigid bag ring 3004 rotates further, bringing the tissue 3006 closer to the surface and allowing for easy access for shredding. Once a sufficient amount of tissue 3006 has been removed, the bag 3002 can then be removed from the patient. Figure 138C shows the tissue guard 200 in the body opening and ready to be inserted into the bag 3002 at any time.

[0139] Referring to Figures 139A to 139C, the bag 3002 is connected to a transport shaft 3038 configured to open and close the mouth of the bag 3002. When the transport shaft 3038 is in the open position, it is used to conveniently scoop up the sample 3006. After the transport shaft 3038 captures the sample 3006 and brings the bag ring 3004 through the body opening to the surface for shredding and removal of the sample 3006, the transport shaft 3038 is operated to close the mouth of the bag 3002. The bag 3002 has an open top, and the semi-rigid bag ring 3004 is attached to this top. The bag 3002 is attached to a bifurcated (with two forks) shaft 3038. The forks are made of a semi-rigid material, such as spring steel. The purpose of the transport shaft 3038 is to allow the bag to be operated with high precision and very easily. The system can be deployed in the abdomen via a trocar cannula 3044. The specimen 3006 is placed in the bag 3002, and the bag 3002 is retrieved by passing it through the abdominal wall 3056. To retrieve the bag 3002, the bifurcated shaft 3038 is passed through the trocar cannula 3044 and pulled until the corner of the bag 3002 enters the distal tip of the trocar cannula 3044. Once the bag 3002 is engaged with the trocar cannula 3044, it is best to pass the bag 3002 through the wound opening and pull it up to the surface. The entire bag 3002 will not pass through. The semi-rigid bag ring 3004 is the only part that can reach the surface. Once positioned at the surface, it is best to remove the bifurcated transport shaft 3038 from the semi-rigid bag ring 3004. The cross-section of the semi-rigid bag ring 3004 is designed to allow the bag 3002 to be shortened by the rounding method. This not only shortens the bag 3002 but also aids in wound retraction. The tissue sample 3006 acts as an anchor, enabling retraction of the wound opening, thereby allowing for a high level of access to the tissue 3006 by an electric or manual shredding instrument. Once the bag 3002 is in position, shredding can begin. As the size of the tissue sample 3006 decreases, the semi-rigid bag ring 3004 rotates further on itself, bringing the tissue 3006 closer to the surface and facilitating easy access for shredding.Once a sufficient amount of tissue 3006 has been removed, the bag 3002 is then removed from the patient. In another configuration example, the bag 3002 is equipped with a second bag ring 3040. The second bag ring 3040 is attached to the bag 3002 at approximately an intermediate distance below the bag 3002. This second bag ring 3040 acts as an anchor that can shorten the bag 3002 while simultaneously retracting the wound to its greatest potential opening. The bag 3002 is attached to a bifurcated (with two forks) delivery shaft 3038. The forks are semi-rigid. With the first bag ring 3004 positioned outside the patient's body, the first bag ring 3004 is rotated / flipped over by itself. The cross-section of the semi-rigid first bag ring 3004 is designed to allow the bag 3002 to be shortened by the rounding method. This not only shortens the bag 3002 but also aids in wound retraction. The second bag ring 3040, located midway below bag 3002, acts as an anchor, enabling maximum retraction of the wound opening. This allows for greater access to the tissue 3006 by various trimming instruments. Once bag 3002 is in place, trimming can begin. Once a sufficient portion of the tissue 3006 has been removed, bag 3002 should be removed from the patient.

[0140] Referring next to Figures 140A and 140B and Figures 141A to 141D, another embodiment of the bag 3002 of the present invention is shown. The bag 3002 has side walls defining the interior and opening. A first bag ring 3004 and a second bag ring 3040 are provided. The second bag ring 3040 is connected to the first bag ring 3004 by its side walls, spaced distal to the first bag ring 3004. The bag 3002 has a balloon 3042 provided at the bottom of the bag 3002. The balloon 3042 forms at least part of the base of the bag, and this balloon has a deflated state and an inflated state. The interior of the balloon 3042 is interconnected to an inflation pressure source that provides positive pressure into the balloon 3042. The inflation pressure source can also provide negative pressure to extract inflation fluid to deflate the balloon 3042 if desired by the user. The inflation pressure source is activated manually or automatically by the user. The balloon 3042 at the base of the bag 3002 is positioned distally from the second bag ring 3040, as shown in Figure 140A. Figure 141A shows the bag 3002 inserted into the body through the body wall 3056, with the first bag ring 3004 pulled outwards to allow access to the inside of the bag 3002, and as a result, the specimen 3006 inside the bag can be removed from the bag 3002. Figure 141B shows the proximal end and opening of the bag 3002 pulled out until the second bag ring 3040 substantially engages with the underside of the body wall 3056. Figure 141C shows the first bag ring 3004 rotated on its own to wrap the side wall of the bag 3002 around the first bag ring 3004. As the first bag ring 3004 rotates on its own, the length of the side wall located between the first bag ring 3004 and the second bag ring 3040 decreases. This decrease in the length of the side wall brings the base of the bag 3002 and the specimen contained within the bag 3002 closer to the opening on the body surface. Figure 141D shows the balloon 3042 in an inflated state, which further lifts the specimen 3006 closer to the opening to facilitate visualization, shredding, and removal.The balloon 3042 advantageously serves as an additional protective interface or barrier between the inside and outside of the bag 3002. For example, if a shredding instrument, such as a knife, electric shredder, or gripper, accidentally tears the proximal end of the balloon 3042 facing into the inside of the bag 3002, the balloon 3042 may deflate, but the overall integrity of the bag 3002 will not be compromised because the containment barrier against the outside or side walls of the bag remains intact. Essentially, the balloon 3042 provides a double wall, an additional protective measure at the location of the base, which is likely to come into contact with sharp instruments during shredding. The inflatable base of the bag 3002 also provides a pedestal effect for the tissue sample 3006, even if the center of the tissue 3006 is not located on the top of the balloon 3042. Furthermore, the inflatable base of bag 3002, when inflated, provides a moat-like space for bodily fluids, such as blood, to flow out of the specimen 3006. When inflated, the inner wall of balloon 3042 is positioned at a further significant distance from the outer wall of the double-walled base, thereby keeping the outer wall away from contact with the instrument and increasing the likelihood that the inner wall will remain intact even if a tear occurs. The double-walled sidewall is preferably used not only at the base but throughout the entire bag 3002. A tear in balloon 3042 and the resulting deflation provide the user with a visual indication that a sharp instrument has struck the balloon, warning the user and ensuring the safety of the outer wall when continuing with retrieval using special care. This is in contrast to a single-walled configuration, which means that a tear in the sidewall is an external tear in bag 3002 without warning. After lifting the sample 3006 to the surface, the sample 3006 can be easily visualized from outside the body through the opening of the bag 3002, thus facilitating the shredding process. The balloon 3042 may be any inflatable material, and it is preferable to incorporate such a balloon into the base of the bag 3002. When shredding is performed, the size of the tissue decreases. As a result, the sample may be lost within the bag 3002, making it difficult to find using the shredder and instruments.By inflating balloon 3042, the tissue 3006 is lifted and brought closer to the end of the shredder and instrument, thereby allowing very easy access to the tissue sample 3006.

[0141] Referring next to Figures 142A-142C and 143A-143D, another configuration of the containment bag 3002 having inflatable sidewalls is shown. The bag 3002 has sidewalls formed to have an open top that serves as a mouth or entrance passage to the interior of the bag 3002. The bag 3002 has a first semi-rigid bag ring 3004 attached to the top near the opening. A second bag ring 3040 is attached to the bottom of the bag 3002 at approximately an intermediate distance. The second bag ring 3040 serves as an anchor that can shorten the bag 3002 while simultaneously retracting the wound to its largest potential opening. The bag 3002 has an air channel 3008 to help expand the lower portion of the bag 3002 containing the specimen. Expanding the lower portion significantly improves the visibility of the specimen as seen from the top. This also helps improve the speed at which the shredding can be performed. The bag 3002 is attached to a bifurcated shaft 3028. The fork is semi-rigid. The purpose of the transport shaft 3028 is to allow the bag 3002 to be manipulated with high precision and very easily. The system can be deployed in the abdomen via the body wall 3056, or in other locations on the body or in the body orifice. The tissue sample 3056 is placed in the bag 3002, and the bag 3002 is retrieved by passing it through the abdominal wall 3056. To retrieve the bag 3002, the bifurcated shaft 3028 is passed through the trocar and pulled until the corner of the bag 3002 enters the trocar. Once the bag 3002 is engaged with the trocar, it is best to pull the bag up to the surface as shown in Figure 143A. Once it is positioned at the surface, it is best to detach the bifurcated shaft from the first semi-rigid bag ring 3004. The entire bag 3002 does not pass through. The semi-rigid first ring 3004 and a portion of the side wall reach the surface. The cross-section of the semi-rigid cap ring 3004 anticipates that the cap 3002 can be shortened by a rounding method indicated by the arrow in Figure 143C. This not only shortens the cap 3002 as shown in Figure 143C but also aids in wound retraction. The second cap ring 3040, located in the middle below the cap 3002, acts as an anchor to allow for maximum retraction of the wound opening.This allows for a high degree of access to the tissue 3006 by the dissector. The bag 3002 performs both a containment function and a retraction function. Once the surgical site is retracted, it is advisable to inflate the air channel 3008 as shown in FIG. 14 3D, and it is advisable to use the optional tissue guard 200. The air channel 3008 expands outwardly, creating a free space around the tissue 3006. This allows the tissue 3006 to be located within the free space. By being located within the free space, the tissue 3006 can roll or move around when being dissected. Once the bag is in a fixed position, it is advisable to start the dissection. Once a sufficient amount of the tissue 3006 has been removed, it is then advisable to remove the bag 3002 from the patient. In another form, the base of the bag 3002 may also be inflatable, for example as described above with reference to FIGS. 140 and 141.

[0142] Next, referring to Figures 144A-144C and 145A-145D, another form of the containment bag 3002 is shown, which has an inflatable sidewall and lacks a second bag ring 3040, but only has a first bag ring 3004. The bag 3002 has an open top, to which the semi-rigid first bag ring 3004 is attached. The bag 3002 utilizes air channels 3008 to help expand the lower portion of the bag 3002 containing the specimen 3006. The air channels 3008 are circumferentially arranged around the perimeter of the bag at the lower portion of the bag. The air channels 3008 are interconnected and can be connected to an inflation pressure source. Positive inflation pressure works to inflate the channels, and negative pressure works to actively deflate the channels 3008. The deflated state is shown in Figure 145A, and the inflated state is shown in Figures 145B to 145D. In one configuration, the most proximal air channel, the air channel closest to the opening of the bag, is annular and larger than the other air channels. Air channel 3008 is a tubular ring-shaped lumen, which is preferably configured to be fluid-coupled to one or more adjacent tubular ring-shaped lumens and to be connectable to an inflation fluid source. This most proximal first annular ring-shaped air channel lumen provides a reaction force applied to the underside of the abdominal wall, allowing for significant retraction when the upper bag ring 3004 rotates downward, thereby generating retraction. Thus, the first annular ring-shaped lumen acts similarly to a second bag ring 3040 of the same configuration. Furthermore, by expanding the lower portion, the visibility of the specimen 3006 as seen from the apical side is greatly improved. This also helps to improve the speed at which the shredding can be performed. The bag 3002 is attached to a bifurcated transport shaft 3038. The forks are semi-rigid. The purpose of the transport shaft 3038 is to allow the bag to be manipulated with high precision and very easily. It is preferable to deploy the system into the abdomen using a trocar. The specimen 3006 is placed in the bag 3002, and the bag 3002 is retrieved by passing it through the abdominal wall of the body.To retrieve bag 3002, the bifurcated shaft is passed through the trocar and pulled until the corner of the bag enters the trocar. Once bag 3002 is engaged with the trocar, it is best to pull the bag up to the surface. The entire bag does not pass through. The semi-rigid bag ring 3004 and a portion of the bag's sidewall are the only parts that reach the surface, as shown in Figures 145A to 145D. Once positioned at the surface, it is best to remove the transport shaft from the semi-rigid bag ring 3004. The cross section of the semi-rigid bag ring 3004 is designed to allow bag 3002 to be shortened by the rounding method shown by the arrow in Figure 145D. This rounding action not only shortens bag 3002 by rounding the sidewall of the bag, but also aids in wound retraction. Next, bag 3002 is inflated. Bag 3002 may be inflated prior to rounding, as shown in the figure. The first annular air channel 3008, located in the middle of the lower part of the bag, acts as an anchor to allow maximum retraction of the wound opening. This allows for a high degree of access to the tissue by the shredder. The air channel 3008 expands outward, creating free space around the tissue 3006. This allows the tissue 3006 to be positioned within this free space. Being within this free space allows the tissue 3006 to roll around and move while being shredded. Once the bag 3002 is in place, it is best to begin shredding. Once a sufficient amount of tissue 3006 has been removed, it is then best to remove the bag 3002 from the patient. In another configuration, the base of the bag 3002 may also be inflatable, as described above, for example with reference to Figures 140 and 141.

[0143] A wide variety of materials can be used for bags and semi-rigid rings. It is sometimes desirable to use multiple materials, such as a hybrid of polymer and woven fabric, in the same bag. Semi-rigid rings are often made from many soft polymer materials, including, but not limited to, pelletane, silicone, KRATON polymer, thermoplastic polyurethane mainly composed of IROGRAN polyester, metals, polymers, plastics, and rubber.

[0144] Any of the containment bags described herein that include an inflatable bag 3002 may be used with a guard or shield configured to be disposed within the bag 3002 to protect the bag sidewall and adjacent tissue edges from sharp manual or powered slicing instruments. Additional examples of guards are shown in FIGS. 146 - 148. FIGS. 146A and 146B show a cylindrical rigid guard 3047 having a circular proximal end 3048 and a funnel-shaped distal end 3050 that flares outwardly like a trumpet. The funnel-shaped guard 3047 serves to collect or funnel tissue toward the cutting blade. The central lumen of the guard 3047 expands in the distal direction. The funnel shape also helps to expand the sidewall of the bag 3002, thereby creating a gap for slicing and preventing the specimen bag from hitting the blade. The guard 3047 may further have a spring-loaded guard feature that prevents it from being exposed when the blade is not engaged with tissue. This allows for safe handling of the slicer. The blade guard may be configured to work with the spring-loaded guard.

[0145] Referring to FIGS. 148A and 148B, the guard 3047 has an inverted funnel or draw-in guard at the distal end, and the central lumen tapers toward the distal end 3050. The draw-in guard 3047 allows for easy coring of the tissue 3006. The blade guard 3047 is conical in shape with the narrow end 3050 facing in the same direction as the leading edge of the blade of the slicing tool. The guard 3047 spreads and pushes the surrounding tissue to one side once the blade engages the surrounding tissue 3006.

[0146] Next, referring to Figures 147A and 147B, another form of the guard 3047 is shown, having anti-rotation studs 3052 extending from the inner surface of the guard 3047 into the central lumen. The inwardly protruding anti-rotation studs 3052 prevent clumps of tissue 3006 from getting caught in the rotating blades and rotating tube when an electric shredder is used. When the tissue 3006 rotates with the blades, there is no relative blade motion, and therefore the blades do not cut the tissue. The anti-rotation studs 3052 may also be provided on the outside of the studs 3052 extending outward from the outer surface of the guard 3047. These protrusions stop the rotation of the guard 3047. The inner anti-rotation studs 3052 also help guide and lead the tissue 3006. The studs 3052 can have various shapes and dimensions. This feature is preferably designed to work in cooperation with any guard. In another form, a bipolar vertical tissue separator is preferably provided within the guard. The bipolar vertical tissue separator feature functions to cut the tissue core from the mass. This mitigates the problem of not being able to separate the core-removed and shredded core from the large mass. This feature is preferably designed to work in cooperation with any blade guard. It is also preferable that a light is provided with the guard 3047, and that this light is preferably formed integrally with it. The purpose of the light source, such as an LED, is to enhance and improve visibility within the tissue bag 3002 so that high scope visibility is obtained. This feature is preferably designed to work in cooperation with any blade guard. The configurations in Figures 147A and 147B further have a plurality of holes 3054 extending across the guard 3047. These holes 5054 serve as vacuum bypass holes 3054 configured to prevent the bag 3002 from being pulled into the blade when the tissue 3006 is drawn out of the bag 3002 using vacuum by a vacuum-powered shredding system, for example. This is achieved by providing radial holes 3054 that are constantly exposed around the guard 3047. Once the blade is engaged with the tissue, the vacuum bypass holes will not adversely affect the vacuum interface with the tissue. This feature is advantageous because it works in conjunction with any blade guard used under vacuum.

[0147] Shredding is performed manually by the surgeon using a knife or electrosurgical instrument. Rather than using a powered shredder, any type of bag described herein is used in conjunction with the manual shredding method. The bag is inserted into the body cavity through the incision. The target tissue is placed in the bag and the opening of the bag is passed through the incision and pulled. A bag guard of the type described herein is inserted into the bag and held near the bag opening, and optionally connected to the proximal end of the bag to keep the bag opening in an open position. The surgeon grasps the tissue with a gripper and pulls it towards the opening and positions it in the guard's place. The surgeon then cuts the tissue into small pieces using a knife rather than a powered shredder and pulls these pieces out of the body. The cutting is performed at the guard's place and / or against the guard so that the bag is not accidentally perforated by the knife. The bag, with or without small tissue pieces, is removed from the body cavity along with the bag guard.

[0148] This system includes a specimen collection bag 3002 attached to a shaft. After deploying the bag 3002 into the body and detaching the desired tissue 3006, the bag can capture this desired tissue 3006. Once the specimen 3006 is placed in the bag 3002, it is preferable to pull it out of the body by passing the semi-rigid ring 3004 attached to the bag opening through the laparoscopy wound, incision, opening, or area near the body opening. After the bag opening ring 3004 has been pulled out of the patient's body, the lower portion of the bag remaining in the body cavity with the specimen 3006 has air channels 3008, which are inflated to form a structure that will become an internal fixing mechanism for the bag 3002 against internal pneumoperitoneum pressure. Next, the outer bag opening ring 3004 is lowered while rotating itself to retract the wound opening in the same manner as described above. The inflated portion of the bag 3002 remaining in the body cavity with the specimen 3006 is now exposed to the surface. Once the specimen bag 3002 is retracted into place, the shredding instrument 3000, equipped with a central hollow rotating blade tube 3010, is attached to the bag opening ring. The shredder 3000 is locked in a stationary position with the blade tube 3010 inserted downward through the wound and into the lower region of the bag 3002 containing the specimen 3006. At this point, the shredder 3000 is turned on to allow the blade tube 3010 to rotate. Once the tube 3010 has rotated, the support hook 3012 is inserted through the hollow rotating blade tube 3010 to grasp the tissue and pull it into the rotating blade tube 3010, and the rotating blade divides the large specimen 3006 into smaller cardiac fragments, which can then be removed through the small laparoscopic wound site. The shredder 3000 further has a camera 3014 located at the distal end of the shredder 3000 to visualize the inside of the specimen bag 3002. Once the tissue 3006 has been completely removed or reduced to a size sufficient to be pulled through the wound, the shredder 3000 is removed from the bag ring, the bag 3002 is deflated, and finally the bag 3002 is pulled through the laparoscopic wound, completing the procedure.

[0149] Referring to Figure 149, a system is shown including an electric shredder 4000 and a bag 4002 connected to the side of the shredder shaft 4004. Further referring to Figures 150A to 150D, the shredder 4000 has a handle 4006 connected to the shaft 4004, and one or more rotating blades 4008 are provided at the distal end of the shaft 4004. The shredder 4000 further has a motor 4010 located within the handle 4006. The motor 4010 is connected to and configured to rotate a gear pinion 4012. The gear pinion 4012 is further connected to a gear train including an inner gear tube 4014 and an outer gear tube 4016. The outer gear tube 4016 is further connected to a spacer 4018, which is connected to an outer shaft 4020. The distal end of the outer shaft 4020 is connected to the blade 4008. The gear inner tube 4014 is connected to the inner shaft 4026, and the inner shaft 4026 is connected to the second blade 4022. The gear outer tube 4016 and the gear inner tube 4014 are configured to rotate in opposite directions to create blades that rotate in opposite directions at their distal ends. In a tube rotating in opposite directions, there are two tubes. One tube is located inside the other. The inner tube rotates in one direction, and the outer tube rotates in the opposite direction. In one configuration, the blade is attached to the end of the outer tube. The technical idea of ​​the tubes rotating in opposite directions is to double the relative velocity experienced by the structure compared to the overall shape of the blade. In any tube configuration, it is preferable that it has an outermost tube that maintains a blade guard configuration. In another configuration, the inner tube is stationary relative to the rotating outer tube. The outer tube has a blade attached to its end, and this outer tube is configured to rotate. The technical idea behind the stationary inner tube is to create a smooth component that allows for easy tissue advancement up the working channel. In another configuration, there is only one tube, with a single outer tube rotating and a blade attached to its end. The inside of the tube is featureless and smooth. In yet another configuration, there are three tubes, with the inner and outer tubes stationary and the intermediate tube rotating.The blade is attached to the end of the intermediate rotating tube, and this blade extends beyond the inner and outer tubes. The stationary outer tube is intended to protect whatever tissue it may be from being rubbed by the rotating intermediate tube. The stationary inner tube is intended to facilitate easy tissue advancement up the tube. In another configuration, a corrugated tissue advancement tube is provided for any tube that is rotating and in contact with the tissue on its inner surface without obstruction. A corrugated pattern is formed on the inner surface of the rotating tube, and the corrugated tube exerts an axial force on the shredded tissue, thereby causing this tissue to advance upward and away from the blade. In yet another configuration, an auger-type tissue advancement tube is provided for any rotating inner tube configuration. The tube has a number of grooves that extend along the length of the inside of the tube. The ends of the grooves grasp the tissue and advance it upward along the grooves away from the blade. As can be seen in Figure 150C, the tubes 4020 and 4026, which rotate in opposite directions, are driven by a single gear 4012, and an overmolded seal or quadring seal 4046 is provided to seal these tubes as shown in Figure 150B. The entire electric motor is housed in the handle 4006, which may be powered by a battery or connected to an external power source.

[0150] A spring-operated blade guard 4024 operates to cover or expose the blades 4008 and 4022, and a trigger 4028 operates to activate the motor 4010. The spring-operated blade guard 4024 operates to expose only the blade 4008 once tissue has come into contact with the end of the blade guard, for increased safety. The shaft of the blade guard 4024, which has an opening and a proximal section, is preferably removable, and the blade guard 4024 is preferably non-rotatable. The inner shaft 4026 and the outer shaft 4020 are concentric and form a working channel 4030 below the middle section. A conical funnel 4032 is provided at the proximal end to facilitate the insertion of an instrument, such as a gripper, into the working channel 4030. The proximal end of the shredder 4000 is also preferably configured to be connected to a vacuum source for the removal of the specimen container 4034 shown in Figure 151 and the shredded specimen. The specimen container 4034 is a transparent container having an inlet port 4038 and a port 4040 on a removable lid that can be connected to a vacuum source. The port 4040 connected to the vacuum source may have a valve for turning the vacuum on or off, and this port may be configured to be electronically actuated. The proximal end of the shredder 4000 is also configured to be connected to a seal assembly 4042, as shown in Figure 150D. The seal assembly 4042 may include a zero seal and a diaphragm seal that make contact with the instrument inserted into an opening provided at the proximal end of the seal assembly 4042. The seal assembly 4042 may further include a port 4044 connected to a fluid source under pressure. The blade guard 4024 has at least one lateral slot or side window opening 4036 configured to expose the blade through the side to receive the tissue to be shredded through the side of the shredder 4000 into the working channel 4030. By rotating or retracting the blade guard 4024, it can cover and close the lateral opening or expose the blade at the distal opening to receive the tissue to be shredded into the working channel 4030 at the distal end opening.

[0151] Next, with reference to Figure 152, a bag 4002 configured to be attachable to a shredder shaft 4004 having a lateral opening 4036 will be described below. In one embodiment of the bag 4002, the bag 4002 has an open top 4048 with a closing mechanism 4050. The shredder shaft 4004 has a rounded end, and this shredder shaft 4004 is connected to the bag 4002. The side of the shredder shaft 4004 has a window-shaped opening 4036. The specimen collection system is introduced into the body, for example, via a trocar or through an open wound or body orifice. Next, the bag 4002 is opened and the tissue specimen is placed into the bag 4002. Next, the bag 4002 is sealed with the closing mechanism 4050. The shredder shaft 4004 is then attached to the shredder 4000, and shredding begins. In a modified configuration, a bag tube 4066 is provided, and the shredder 4000 is easily attached to the bag tube 4066 by sliding the shredder shaft 4004 into the bag tube 4066 as shown in Figures 152 and 159. The bag 4002 may be pre-attached to the bag tube 4066. Once the specimen has been reduced, the specimen collection system is removed from the patient. Examples of shredders are described in U.S. Patent Applications No. 12 / 102,719 and No. 13 / 659,462, filed on 14 April 2008 and 24 October 2012, respectively, and these U.S. Patent Applications are incorporated herein by reference and their entirety is incorporated herein by reference as if it were described herein.

[0152] Next, various bag closure means will be described with reference to Figures 153 to 157. In Figures 153A and 153B, the open top 4048 is closed using a drawstring 4052 located at the top 4048 of the bag. In Figures 154A and 154B, a Ziploc® or zipper-style closure 4054 is provided, which allows the top 4048 to be opened and closed by locking or unlocking two sides of the closure means using a slider. In Figures 155A to 155C, another closure means includes a grommet 4056 formed in the bag 4002 near the top 4048 of the bag. A gripper 4058 or other instrument is inserted into the opening of the grommet 4056 and opened, and then twisted down to roll up the bag 4002 and close the open top 4048, as shown in Figure 155C. In Figures 156A and 156B, the top 4048 is equipped with a hook-and-loop fastener 4060. The open top 4048 of the bag is closed by bringing the opposite sides of the hook-and-loop fasteners into contact. In Figures 157A and 157B, the top 4048 of the bag has a plurality of grommet openings 4062. Specifically, there are four openings 4062. For example, an instrument, such as a gripper 4058, is used to grasp all of the openings 4062, and then the gripper is twisted to roll up the openings and close them as shown in Figure 157B.

[0153] A plastic guard 4064 is provided, as shown in Figures 158A to 158E, to protect the bag 4002 and prevent it from entering a lateral slot 4036 on the shredder shaft 4004 and coming into contact with the rotating blade 4008. The plastic guard 4064 is made of a single piece of semi-rigid plastic and is configured to fold and be inserted into the shredder slot 4036. The plastic guard 4064 is made of a material that is more rigid than the bag 4002 and is configured to surround the lateral opening 4036 and provide a bucket-shaped or funnel-shaped opening to spread the bag 4002 out of the opening 4036. The bag 4002 is attached to the distal end of the shredder shaft 4004. The bag 4002 has an open top 4048 with a closing mechanism 4050. The bag 4002 is located at the lateral opening 4036 of the shredder shaft 4004 and has a semi-rigid structure that allows tissue to be easily placed into the bag 4002. The specimen collection system is introduced into the body via a trocar or open wound or body or other transport mechanism. Next, the bag 4002 is opened and the tissue specimen is placed into the bag 4002. Next, the bag 4002 is sealed with the closing means 4050. The shredder 4000 is attached to the proximal end of the shredder shaft 4004 and shredding begins. In a modified example, a bag tube 4066 is provided, and the shredder 4000 is attached to the bag tube 4066 by sliding the shredder shaft 4004 into the bag tube 4066 as shown in Figure 159. The bag 4002 may be pre-attached to the bag tube 4066 with or without a plastic guard 4064 or reinforcing rigid section provided near the distal opening of the bag tube 4066. The shredding shaft 4004 and the bag tube 4066 are held together by friction through a knob attached to the bag tube 4066. The knob engages with the shredding handle in a snap-fit ​​or friction-fit engagement. Once the specimen is reduced, the specimen collection system is removed from the patient. The semi-rigid structure of the guard 4064 is preferably made of spring steel, nitinol, or molded plastic.The material has a total of three configurations, and the bag 4002 can be closed by using a drawstring method or by wrapping the bag structure around the ends to close the bag 4002. In another configuration shown in Figure 160, the bag 4002 is attached to a bag tube 4066. The bag 4002 has a closing end. The opening 4068 of the bag 4002 is located on the side of the bag 4002. The bag 4002 further has a semi-rigid structure located at the opening that allows tissue to be easily placed into the bag. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a windowed compartment 4070. The specimen collection system is introduced into the abdomen via a trocar or an open wound. Next, the bag 4002 is opened and the tissue specimen is placed inside the bag 4002. Next, the bag is sealed and the shredder 4000 is attached and shredding begins. Once the specimen has been reduced in size, the specimen collection system is removed from the patient. The side opening 4068 may have a reinforcing material made of spring steel, nitinol, or molded plastic located in the middle of the side wall of the bag 4002. The side opening 4068 opens by spring action to form an oval shape, thereby facilitating the insertion of tissue samples into the bag 4002. With respect to the material, there are three configurations in total, and the bag 4002 is closed by using a drawstring method or by rolling the structure around the ends to close the bag 4002. In another embodiment, the spring steel, nitinol, or molded plastic is provided near the bag tube 4066 as shown in Figure 161.

[0154] In another configuration shown in Figures 162A to 162C, the bag 4002 is a separate component from the bag tube 4066. The bag 4002 has two open ends 4072, 4074. One opening 4072 is larger in diameter than the other. The larger end 4072 is semi-rigid, made of spring steel, Nitinol, or plastic material. The larger end 4072 of the bag 4002 can be sealed using various closure means 4050, such as a drawstring 4052 or a pinch-and-roll-down method. The smaller end 4074 has a spring steel or Nitinol clamp 4076 attached to the bag tube 4066. The clamp 4076 is mounted around a rigid blade guard 4064. The taper of the rigid blade guard 4064 helps the clamp 4076 to seat on the rim and prevent it from slipping off the bag tube 4066. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a windowed compartment 4070. First, the bag 4002 is passed through an opening, body orifice, or open wound and introduced into the abdomen by a trocar, transport shaft, instrument, or other deployment method. Next, the large diameter end 4072 of the bag is opened and placed around the tissue sample 4078. Next, the large diameter end 4072 of the bag 4002 is sealed. Next, the bag tube 4066 is introduced into the body. Next, the bag 4002 is attached to the bag tube 4066 by clamp 4076. The shredder 4000 is attached and shredding begins. Once the specimen 4078 has been reduced in size, the retrieval system is removed from the patient.

[0155] In another configuration shown in Figures 163A to 163C, the bag 4002 is attached to a bag tube 4066 called a bag tube. The bag 4002 has an open end. The bag tube 4066 has a rounded end. The bag tube 4066 has an oversheath. The tip of the sheath has two holes to facilitate the operation of a nitinol or other flexible semi-rigid drawstring 4052 to open and close the semi-rigid bag opening 4068. The sheath further has two channels parallel to the axis of the tube to facilitate the recovery of the nitinol. The side of the tube has a windowed section 4070. The specimen recovery system is introduced into the body by passing it through the opening as shown in Figure 163B. The bag 4002 is then opened by loosening the drawstring 4052, and the tissue specimen 4078 is recovered by surrounding the tissue specimen 4078 with the nitinol and the net made by the bag 4002. This can be done with or without the assistance of a grasping or cutting device. Once the tissue 4078 is enclosed, the nitinol can be retrieved proximally by the drawstring 4052, thereby closing the bag 4002 around the tissue sample 4078 and sealing the bag 4002. Attach the shredder and begin shredding. Once the specimen 4078 is reduced, remove the retrieval system from the patient.

[0156] In another configuration, the bag 4002 has an open top to which a semi-rigid ring is attached. The bag 4002 is tightly rolled up and then deployed into the abdomen via a trocar. Next, the bag 4002 is opened internally by manipulation with a gripper. The specimen 4078 is placed into the bag 4002 and the bag 4002 is retrieved by passing it through the abdominal wall. The entire bag 4002 does not pass through. The semi-rigid bag ring is the only part that reaches the surface while the rest of the bag remains in the abdominal cavity of the body. Dissection can then be initiated. Once a sufficient amount of tissue 4078 has been removed, the bag 4002 should then be removed from the patient.

[0157] The tissue guards described herein are typically used in conjunction with a containment bag. The bag is placed inside the body through a body orifice. A body orifice refers to any entry point in the patient, which may include, but is not limited to, incision sites and congenital orifices. The target specimen is generally too large to be safely removed through a body orifice and must be manipulated, for example, by cutting it with a blade, with the aim of removing the target specimen through the body orifice. Minimally invasive laparoscopic body orifices are generally smaller than the size of the target specimen. The target specimen is placed in the bag, and the opening of the bag is pulled out of the patient's body. The guard is placed inside the opening of the bag and secured across the body orifice, drawing the target specimen into the lumen of the guard. While inside the lumen of the guard, the target specimen is within a protective cutting zone, within this zone, the surgeon uses a blade to reach the target specimen and cut it so that it can be removed. The guard provides protection from erratic blades and also serves as a direct cutting surface, which is preferably positioned to reduce tissue. The overall length of the guard determines the length of the shredding zone that protects the bag and tissue at the edge of the body opening. In addition, it is preferable to use a retractor. The retractor may be formed integrally with the bag or may be a separate standalone instrument. A typical retractor described herein is a two-ring type retractor, in which a flexible sidewall material is positioned between the two rings. The sidewall of the retractor is configured to wrap around the first ring to retract tissue at the edge of the body opening. When using a retractor, it is preferable to position the retractor inside the bag between the marginal tissue and the bag, or between the bag and the guard. The above description relates to various uses of the guard, bag, and retractor used in manual shredding. In the case of electric shredding, the guard is inserted into the bag and then shredding is performed. In another form of electric shredding, a stabilizing cap is attached to the proximal ring of the bag or the proximal end of the guard to perform electric shredding. The stabilizing cap helps to define the vertical position of the blade, thereby preventing the blade from extending beyond a predetermined shredding zone at a short distance within the guard or safely beyond the distal end of the guard.In another form of electric shredding, a retractor is used, in which case the retractor is placed between the marginal tissue and the pouch or between the pouch and the guard as described above, and electric shredding is performed. In the above form, a stabilizing cap is preferably used so that it is connected to the proximal ring of the retractor, the proximal ring of the pouch, or the proximal end of the guard, and shredding is performed. For example, when performing a procedure such as hysterectomy, in addition to the above forms, any one of the following methods may be used in association with any of the above forms. In one form, the pouch is inserted into the vagina and placed in the body, the target specimen (e.g., uterus) is placed into the pouch while the pouch is in the body cavity, then the mouth of the pouch is passed through the abdominal incision and pulled, the guard is inserted into the mouth of the pouch, and shredding, removal, and pouch removal are performed at the abdominal opening. In another configuration, the bag is inserted into the vagina and placed inside the body, the target specimen (e.g., uterus) is placed into the bag while the bag is positioned within the body cavity, then the opening of the bag is passed through the vaginal canal and pulled back, a guard is inserted into the opening of the bag, and the shredding, removal, and bag removal are performed at the vagina. In yet another configuration, the bag is inserted into the body through an abdominal incision and placed inside the body, the target specimen (e.g., uterus) is placed into the bag while the bag is positioned within the body cavity, then the opening of the bag is passed through the vaginal canal and pulled back, a guard is inserted into the opening of the bag, and the shredding, removal, and bag removal are performed at the vagina. In yet another configuration, the bag is inserted into the body through an abdominal incision and placed inside the body, the target specimen (e.g., uterus) is placed into the bag while the bag is positioned within the body cavity, then the opening of the bag is passed through the abdominal incision and pulled back, a guard is inserted into the opening of the bag, and the shredding, removal, and bag removal are performed at the vagina. In another method relating to the shredding of the uterus or other target specimens, the bag may be omitted. In such cases, an incision is made in the abdominal wall, a guard is placed across the abdominal incision, the uterus or target specimen is dissected and pulled through the central lumen of the guard, and the shredding and removal are performed at the abdominal incision. In a modified version, the target specimen (e.g., uterus) is approached from the vagina, a guard is placed in the vaginal canal, the target specimen is dissected and pulled through the central lumen of the guard, and the shredding and removal are performed at the vagina. As another form of abdominal approach without the use of a bag, this procedure can be observed using a laparoscope inserted through the vagina. As another form of vaginal approach without the use of a bag, this procedure can be observed using a laparoscope inserted through an incision made in the abdomen.

[0158] In some cases, a guard is not used. In one such form without a guard, the bag is placed into the body cavity via the vagina, the target specimen is placed into the bag, the opening of the bag is passed through the abdominal incision and pulled back, the retractor is placed inside the bag across the abdominal incision, and the shredding, removal and bag removal are performed at the abdominal incision. In another form without a guard, the bag is placed into the body cavity via the vaginal canal, the target specimen is placed into the bag, the opening of the bag is passed through the vaginal canal and pulled back, the retractor is placed inside the bag in the vaginal canal, and the shredding, removal and bag removal are performed at the vagina. In yet another form without a guard, the bag is placed into the body cavity via the abdominal incision, the target specimen is placed into the bag, the opening of the bag is passed through the vaginal canal and pulled back, the retractor is placed inside the bag in the vaginal canal, and the shredding, removal and bag removal are performed at the vagina. In an alternative configuration where a guard is not used, the bag is placed in the body cavity via an abdominal incision, the target specimen is placed in the bag, the opening of the bag is passed through the abdominal incision and pulled, and the retractor is placed inside the bag in the vaginal canal. Then, shredding, removal, and bag removal are performed at the abdominal incision. In any configuration where a retractor is used without a guard, it is preferable to use any of the above-mentioned cut-resistant retractors. In any configuration where a retractor is used without a guard, it is preferable to place the retractor between the bag and the tissue edge. In any configuration where a retractor is used without a guard or without a retractor, it is preferable to use any of the above-mentioned cut-resistant bags. Electric shredding is also preferable in any method where a guard is used. In such cases, a stabilizing cap is used to connect to the proximal end of the bag or the proximal ring of the retractor.

[0159] In configurations where a retractor is used without a guard, a cut-resistant retractor is provided. The retractor has a first ring and a compressible second ring connected to each other by webbing or sidewalls. The retractor is configured so that webbing can be wrapped around the first ring, thereby reducing the length of the retractor and allowing tissue edges to be retracted. The bottom ring is inserted through a body opening, and this bottom ring is located inside the patient's body, while the top ring of the retractor is located above the patient. The top ring is rotated / inverted like a bag to pull the lower ring of the retractor closer and to the sidewalls, creating a taut relationship between the rings. The lower ring of the retractor advantageously retracts the portion of the bag inside the patient's body, preventing potential damage caused by puncture and tearing by the blade. At least a portion of the webbing is made of a puncture-resistant and cut-resistant material. The retractor is configured to be inserted into the containment bag and into the body opening to retract the bag and tissue edges, with the first ring of the retractor and the opening of the containment bag located outside the patient's body, and the second ring of the retractor and the remainder of the containment bag located inside the patient's body. This arrangement of the bag between the retractor and the tissue edge at the body opening causes the bag to become fixed to the patient's body. In one embodiment, only the distal portion of the webbing, approximately 4 inches (10.16 cm) long, is cut-resistant and made of KEBLAR, DYNEEMA, or other cut-resistant material, while the proximal portion of the webbing is not made of cut-resistant material and is made of polyurethane or other flexible film. This configuration allows the proximal end of the webbing to be easily wrapped around the first ring during retraction. Reducing the length of the webbing by rolling it up brings the distal cut-resistant portion of the webbing closer to the proximal end of the retractor or the first ring and into a position to protect the shredding to be performed. In the case of thick and bulky, low-cut-resistant materials, the retractor is inexpensive and allows for easy reversal and rotation of the first ring, because the low-cut-resistant material is wrapped around the first ring. In another configuration, the entire webbing is made of a cut-resistant material.For example, in another form used in the vagina, only the proximal portion of the approximately 5-inch (12.70 cm) long webbing is cut-resistant and made of KEBLAR, DYNEEMA, or other cut-resistant material, while the distal portion of the webbing is not made of cut-resistant material and is made of polyurethane or other soft film to increase flexibility and allow it to be fixed at the proximal end. In vaginal surgical procedures, such as total laparoscopic hysterectomy, the first ring at the proximal end does not need to be rolled down to the same extent. Therefore, the proximal end of the webbing is made of cut-resistant material compared to abdominal surgical procedures, where the webbing is wrapped very slightly around the first ring and the proximal end is not made of cut-resistant material.

[0160] According to one aspect of the present invention, a contamination prevention system for manual or electric field shredding is provided. The system includes a containment bag with an opening and a shield configured to be removably inserted into the opening of the bag. The shield has a central lumen that serves as a working channel for shredding and protects the bag and surrounding tissue.

[0161] According to another aspect of the present invention, an instrument is provided for safely removing a tissue specimen from a body cavity by passing it through a body opening smaller than the tissue specimen. The instrument has a removable shield configured to be fixed inside the body opening. The instrument further has a bag or retractor positioned between the body opening and the shield.

[0162] According to another aspect of the present invention, a shield is provided having side walls defining a central opening. The shield has a C-shaped concave outer surface that anchors the shield within the body opening.

[0163] According to another aspect of the present invention, a shield having sidewalls defining a central opening is provided. The shield has a C-shaped concave outer surface for fixing the shield within the body opening. The shield is divided such that a portion of the shield is fitted within another portion of the shield, and the shield is expandable from a reduced side configuration to an expanded side configuration by varying the fitted portions of the shield, or vice versa.

[0164] According to another aspect of the present invention, an expandable shield having sidewalls defining a central opening is provided. The shield is capable of moving between a first configuration and a second configuration. The first configuration has dimensions larger than those in the second configuration, and these dimensions are vertical and / or lateral dimensions.

[0165] According to another aspect of the present invention, a system for preventing the potential spread of cancerous cells when removing a large tissue specimen from a small opening in the body is provided. The system includes a container and a mincing zone. The mincing zone can be inserted into and removed from the container. The mincing zone protects the container from penetration by a mincing instrument.

[0166] According to another aspect of the present invention, a shield is provided. The shield has a blade connected to the shield. The blade is capable of moving along a predetermined path with respect to the shield, and the shield surrounds at least a portion of the predetermined path to protect the tissue surrounding the body opening.

[0167] As will be appreciated, various modifications can be made to the embodiments disclosed herein. Accordingly, the above description should not be construed as limiting the present invention, but should be construed merely as an exemplification of the preferred embodiments. Those skilled in the art will envision other modifications that fall within the scope and spirit of the present invention.

Claims

1. A system for safely removing a tissue sample through a body opening, wherein the body opening defines the tissue margin, and the system, The retractor comprises a first ring and a second ring connected to each other by side walls defining a central lumen having an upper and lower opening, the second ring being compressible into a low-profile form for insertion through the body opening, the first ring having a first ring diameter, and the retractor being configured such that the side walls are rounded around the first ring to reduce the length of the retractor while expanding the tissue margin. The shield includes a shield made of a cut-resistant material having a proximal end and a distal end connected to each other by side walls, the shield having an inner surface, an outer surface and an elongated tubular working channel extending from the proximal end to the distal end along the longitudinal axis, the shield having a proximal flange provided at the proximal end, the proximal flange flaring radially outward and forming a funnel-shaped inlet to the working channel, The shield is sized and shaped to be detachably connected to the retractor when the retractor is positioned within the body opening and the shield is inserted into the central lumen of the retractor. The shield is divided from the proximal end to the distal end, defining a first end and a second end, each of the first and second ends having an S-shaped curved form, and the S-shaped curved form overlaps the outer surface of adjacent shield portions in a relaxed state, in a system.

2. The system according to claim 1, wherein the proximal end of the shield is configured to be connected to the first ring of the retractor.

3. The system according to claim 1, wherein the proximal end of the shield is configured to be connected to the first ring of the retractor by snapping the proximal flange under the first ring.

4. The system according to any one of claims 1 to 3, wherein, when viewed in a cross section taken perpendicular to the longitudinal axis, the dimensions of the working channel of the shield increase with increasing distance toward the distal end of the shield.

5. The system according to any one of claims 1 to 4, wherein the inner diameter of the shield is adjustable to increase or decrease the dimensions of the work channel.

6. The system according to any one of claims 1 to 5, wherein the outer surface of the shield is concave, and the outer surface gradually widens radially outward from the inflection point toward the distal and proximal ends of the shield.

7. The system according to claim 6, wherein the inflection point is located near the proximal flange above the intermediate surface taken perpendicular to the longitudinal axis.

8. The system according to any one of claims 1 to 7, wherein the S-shaped curve of one of the first or second ends overlaps the outer surface of the adjacent shield portion to define an overlap portion.

9. The system according to claim 8, wherein the shield is configured to increase or decrease the dimensions of the work channel by increasing or decreasing the circumferential length of the overlap portion.

10. The system according to any one of claims 1 to 9, wherein the shield is molded with a bias toward the relaxed shape such that when the dimensions of the working channel increase or decrease, the shield returns toward the relaxed shape.

11. The system according to any one of claims 1 to 10, wherein the S-shaped curved portions of the first end and the second end are configured to transition into notches near the proximal and distal ends of the shield.

12. The system according to claim 11, wherein the notches form finger-shaped extensions configured to fit together and function as a locking mechanism to fix the dimensions of the work channel in the diametrical direction.

13. The system according to any one of claims 1 to 12, further comprising a storage bag, the storage bag having an interior and an opening for accessing the interior of the storage bag, the storage bag having a proximal end and a distal end, and the storage bag being sized and shaped to receive the retractor and the shield within the storage bag so that the retractor is positioned between the shield and the storage bag.

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