Systems and methods for tissue removal

Abstract

To provide systems and methods for preventing the seeding of cancerous cells during morcellation of a tissue specimen inside a patient's body and removal of the tissue specimen from inside the patient through a minimally invasive body opening to outside the patient's body.SOLUTION: One system includes a cut-resistant tissue guard removably insertable into a containment bag. The tissue specimen is isolated and contained in the containment bag, and the guard is configured to protect the containment bag and surrounding tissue from incidental contact with sharp instrumentation used during morcellation and extraction of the tissue specimen. The guard is adjustable to allow easy insertion and removal and configured to securely anchor to the body opening. Protection-focused and containment-based systems for tissue removal are provided that enable minimally invasive procedures to be performed safely and efficiently.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to medical devices, and more particularly to systems and methods for the extraction or removal of tissue from a body orifice.

[0002] Description of Related Applications This application claims priority to and benefits from U.S. Provisional Patent Application No. 62 / 079,171, filed November 13, 2014, entitled "Systems and methods for tissue removal," U.S. Provisional Patent Application No. 62 / 081,297, filed November 18, 2014, entitled "Systems and methods for tissue removal," and U.S. Provisional Patent Application No. 62 / 107,107, filed January 23, 2015, entitled "Cut-resistant retracting tissue bag." [Background technology]

[0003] Systems and methods for surgical removal of tissue from small incisions and / or bodily orifices, including various bodily orifices, have been described. When necessary, a small incision is made in a patient to access the surgically targeted tissue located within a body cavity. The surgically targeted tissue can also be accessed through a bodily orifice without an initial incision. In some cases, the target tissue is accessed directly through the incision or orifice. In some cases, an access device system is placed and positioned in, across, at, and / or within the incision and / or orifice to retract, enlarge, reshape, and / or isolate the tissue. The access or access device system serves as a gate or portal for accessing the target tissue located within or adjacent to a body cavity or orifice. The target tissue is dissected from adjacent and surrounding tissue using known surgical techniques or procedures. Once freed, the target tissue is ready for removal through the small incision or orifice. If the target tissue is too large to remove in its entirety, the target tissue is reduced in size and removed in sections through small incisions. Ideally, the surgeon will "core" or "peel" the target tissue to keep it as whole as possible. However, more than 50% of the time, the target tissue ends up in many small pieces.

[0004] Reducing the size of target tissue is called morcellation. Morcellation involves manually using a scalpel or knife or employing a powered morcellator to cut the target tissue into small pieces and remove the target tissue through a small incision. The small pieces of target tissue are removed from the patient through the small incision. When reducing the size of the target tissue to fit through the small incision, small pieces of tissue may be cut off and left inside the patient. Therefore, morcellation is contraindicated in cases of malignant tumors or endometriosis. If cancer is morcellated, such morcellation may lead to the spread of malignant tissue, upstaging the cancer, and increased patient mortality.

[0005] Hysterectomy is one example of a surgical procedure that may involve morcellation. Over 500,000 hysterectomies are performed annually on women in the United States. Women typically undergo hysterectomies for the presence of fibroids, cancer, endometriosis, or uterine prolapse. Approximately 200,000 of these hysterectomies are performed laparoscopically. If the uterus is too large (over 300 g) to be removed through the vagina or if the cervix is ​​still in place, the specimen must be reduced in size for removal through an abdominal incision or through the vagina. During myomectomy (fibroid removal), it may be necessary to remove large fibroids using a morcellation technique. During morcellation, the target tissue (usually the uterus and possibly adnexal structures) is brought to the abdominal wall surface, for example, with a tissue grasper, reduced in size with a blade, and removed from the pelvic cavity through the incision. Alternatively, the target tissue is removed through a body orifice, for example, the vagina. Fibroids or uterine leiomyomas account for approximately 30% to 40% of hysterectomies. These benign uterine tumors can cause severe and painful bleeding. In the past, these tumors were thought to be missed cancers or leiomyosarcoma, affecting approximately 1 in 10,000 women. More recent data support the extremely high risk of missed malignancies among these tumors, estimated to range from 1:1000 to 1:400. Because of this high risk, many surgeons have begun to adapt their surgical techniques to perform a closed morcellation process, rather than performing morcellation without a pouch, a process called open morcellation, in which the specimen is enclosed within a pouch to contain stray particles and prevent the spread and seeding of tumor cells. Many gynecologic societies, including the American Academy of Gynaecology (AAGL), American College of Gynaecology (ACOG), and American Society of Gynaecology (SGO), have issued statements warning of the potential dangers of open morcellation. Effective April 17, 2014, the FDA issued a statement discouraging the use of open power morcellation for the performance of hysterectomies and myomectomies for 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 specimens. The present invention relates to such safe systems and methods for both manual and powered morcellation performed in a closed system. Summary of the Invention

[0006] According to one aspect of the present invention, a system for removing a tissue specimen through a body opening defining a tissue margin is provided. The system includes a shield having a band made of a soft, cut-resistant material. The band has inner and outer surfaces connected to each other by top and bottom ends and first and second ends. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that at least a portion of the outer surface at the first end overlaps with the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, allowing the band to move to a contracted configuration that defines an overlapping portion. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed on the inner surface. The inner abutment extends along at least a portion of the band along the longitudinal axis between the top and bottom ends. The first end is configured to contact the inner abutment to prevent reduction of the inner diameter in the locked configuration.

[0007] According to another aspect of the present invention, a system for removing a tissue specimen through a body opening defining a tissue margin is provided. The system includes a shield having a band made of a soft, cut-resistant material. The band has inner and outer surfaces connected to each other by top and bottom ends and first and second ends. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that at least a portion of the outer surface at the first end overlaps the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, allowing the band to move to a contracted configuration. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed on the inner surface and at least one outer abutment formed on the outer surface. The inner and outer abutments extend along at least a portion of the band along the longitudinal axis between the top and bottom ends, and the at least one inner abutment is configured to contact the at least one outer abutment to prevent reduction of the inner diameter in the locked configuration.

[0008] According to another aspect of the present invention, a system for removing a tissue specimen through a body opening defining a tissue margin is provided. The system includes a shield having a band made of a soft, cut-resistant material. The band has inner and outer surfaces connected to each other by top and bottom ends and first and second ends. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that at least a portion of the outer surface at the first end overlaps the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, allowing the band to move to a contracted configuration that defines an overlapping portion. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed within the inner surface. The at least one inner abutment is configured to contact one of the first end or the at least one outer abutment formed in the outer surface to define a locked configuration having a locked lumen diameter. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a cross-sectional view of a containment bag and guard according to the present invention positioned within an opening in a body wall. [Figure 2] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 3] FIG. 2 is a side view of a guard according to the present invention. [Figure 4] FIG. 1 is an end view of a guard according to the present invention. [Figure 5] 5 is a cross-sectional view of the guard according to the present invention taken along line 5-5 of FIG. 4. [Figure 6] 6 is a cross-sectional view of the guard according to the present invention taken along line 6-6 of FIG. 4. [Figure 7] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 8] FIG. 2 is a side view of a guard according to the present invention. [Figure 9] FIG. 1 is an end view of a guard according to the present invention. [Figure 10] 10 is a cross-sectional view of the guard according to the present invention taken along line 10-10 of FIG. 9. [Figure 11] FIG. 1 is a top perspective view of a cap according to the present invention. [Figure 12] 1 is a cross-sectional side view of a cap and guard according to the present invention. [Figure 13] FIG. 1 is a side view of a cap and guard according to the present invention. [Figure 14] FIG. 1 is a top perspective view of a cap and guard according to the present invention. [Figure 15] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 16] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 17] 1 is a cross-sectional side view of a guard according to the present invention; [Figure 18] 1 is a top perspective view of a retractor according to the present invention; FIG. [Figure 19] 1 is a top perspective view of a retractor according to the present invention; FIG. [Figure 20A] FIG. 1 is a top perspective view of a containment bag and retractor combination according to the present invention. [Figure 20B] 1 is a cross-sectional side view of a containment bag with a tissue specimen, a body wall, and two rings according to the present invention. [Figure 21] 1 is a top perspective view of a containment bag in an expanded state according to the present invention; FIG. [Figure 22] FIG. 1 is a top perspective view of a containment bag in a partially collapsed state according to the present invention. [Figure 23] 1 is a top perspective view of a containment bag according to the present invention in a twisted state; FIG. [Figure 24] 1 is a plan view of a twisted storage bag according to the present invention; FIG. [Figure 25A] FIG. 1 is a top perspective view of an unassembled two-piece guard according to the present invention. [Figure 25B]FIG. 1 is a top perspective view of an assembled two-piece guard according to the present invention. [Figure 26] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 27] FIG. 1 is a top perspective view of a retractor ring and guard according to the present invention. [Figure 28] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 29] 1 is a partial cross-sectional view of a retractor ring and guard according to the present invention. [Figure 30] FIG. 1 is a top perspective view of a balloon trocar with a removable seal housing according to the present invention. [Figure 31] 1 is a cross-sectional side view of a balloon trocar according to the present invention. [Figure 32] FIG. 2 is a side view of a ballast according to the present invention. [Figure 33] FIG. 2 is a bottom view of a ballast according to the present invention. [Figure 34] 34 is a cross-sectional view of the ballast of the present invention taken along line 34-34 of FIG. 33. [Figure 35] FIG. 1 is a side view of a morsel stabilizer according to the present invention. [Figure 36] 1 is a cross-sectional plan view of a morsel stabilizer in a locked configuration in accordance with the present invention; FIG. [Figure 37A] FIG. 2 is a top view of a ballast according to the present invention in an unlocked configuration. [Figure 37B] FIG. 1 is a cross-sectional plan view of a morsel stabilizer in an unlocked configuration in accordance with the present invention. [Figure 38] 1 is a top perspective view of a containment bag positioned within a body opening in accordance with the present invention; [Figure 39] FIG. 1 is a top perspective view of a containment bag positioned within a body orifice and a morcellator stabilizer coupled to the containment bag in an unlocked configuration in accordance with the present invention. [Figure 40] FIG. 1 is a top perspective view of a morcellator having a protective obturator connected to a stabilizing cap in accordance with the present invention. [Figure 41]FIG. 1 is a bottom perspective view of a mortar having a protective obturator connected to a stabilizing cap in accordance with the present invention. [Figure 42] FIG. 1 is a top perspective view of a morcellator coupled to a stabilizing cap in accordance with the present invention. [Figure 43] FIG. 1 is a top perspective view of a stabilizer cap according to the present invention. [Figure 44] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 45] 1 is a cross-sectional side view of a tissue specimen within a containment bag positioned across a body wall in accordance with the present invention. [Figure 46] 1 is a side view of a containment bag deployment device according to the present invention; [Figure 47] FIG. 1 is a side view of a containment bag and deployment cap according to the present invention. [Figure 48] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 49] 1 is a cross-sectional side view of a tissue specimen within a containment bag positioned across a body wall in accordance with the present invention. [Figure 50] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 50A] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 50B] 1 is a plan view of a storage bag according to the present invention; [Figure 50C] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 50D] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 50E] FIG. 1 is a plan view of a pattern for a containment bag according to the present invention, in which the solid lines show the valley folds and the dashed lines show the angle folds. [Figure 50F] FIG. 1 is a partial plan view of a pattern with dimensions for a containment bag according to the present invention. [Figure 50G] 1 is a plan view of a pattern for a containment bag that is substantially square when viewed from above in accordance with the present invention; [Figure 50H] 1 is a plan view of a containment bag with a triangular open end in accordance with the present invention; FIG. [Figure 51]FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 52] FIG. 1 is a top perspective view of a guard in a mold according to the present invention. [Figure 53] FIG. 1 is a top perspective view of a guard on a mold according to the present invention. [Figure 54] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 55A] 1 is a side view of a ring of a containment bag according to the present invention; [Figure 55B] 55B is a cross-sectional view of the ring of the storage bag according to the present invention taken along line 55B-55B in FIG. 55A. [Figure 56A] FIG. 1 is a top perspective view of a semi-rigid rod before being formed into a ring for a containment bag according to the present invention. [Figure 56B] 1 is a top perspective view of a ring of a containment bag according to the present invention; FIG. [Figure 57A] FIG. 2 is a plan view of a side wall of a containment bag according to the present invention. [Figure 57B] FIG. 2 is a side view of a side wall of a containment bag according to the present invention. [Figure 58A] 1 is a side view of a containment bag according to the present invention. [Figure 58B] 5 is a cross-sectional view of the storage bag 58A taken along line 58B according to the present invention. FIG. [Figure 59A] 1 is a side view of a containment bag according to the present invention. [Figure 59B] 1 is a top perspective view of a containment bag according to the present invention; FIG. [Figure 60] 1 is a top perspective view of a bag introducer according to the present invention; FIG. [Figure 61] 1 is a top perspective view of a bag introducer according to the present invention; FIG. [Figure 62] FIG. 1 is a top perspective view of a containment bag and bag introducer according to the present invention. [Figure 63] FIG. 1 is a top perspective view of a containment bag and bag introducer according to the present invention. [Figure 64] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 65]1 is a cross-sectional side view of a tissue specimen within a containment bag and guard positioned across a body wall in accordance with the present invention. [Figure 66] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 67] FIG. 1 is a side view of two side wall components of a guard according to the present invention. [Figure 68] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 69] FIG. 2 is a side view of a guard according to the present invention. [Figure 70] 1 is a side view of a guard within a body opening according to the present invention; [Figure 71A] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 71B] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 72] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 73] FIG. 2 is a partial perspective side view of a guard according to the present invention. [Figure 74] FIG. 2 is a partial perspective side view of a guard according to the present invention. [Figure 75] 1 is a cross-sectional view of a side wall of a guard according to the present invention. [Figure 76] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 77] FIG. 2 is a side view of a guard according to the present invention. [Figure 78A] FIG. 2 is a semi-transparent bottom view of a guard according to the present invention. [Figure 78B] 1 is a semi-transparent plan view of a guard according to the present invention; [Figure 78C] 78C-78C is a cross-sectional view of the guard according to the present invention taken along line 78C-78C of FIG. 78B. [Figure 79] 1 is a top perspective, partially see-through view of a guard according to the present invention; FIG. [Figure 80] FIG. 1 is a plan view of a guard according to the present invention. [Figure 81] FIG. 1 is a plan view of a guard according to the present invention. [Figure 82] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 83] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 84] 1 is a cross-sectional plan view of a guard according to the present invention; [Figure 85] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 86] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 87] FIG. 1 is a side view of a morcellator and guard according to the present invention. [Figure 88] FIG. 1 is a cross-sectional side view of a morcellator and guard according to the present invention. [Figure 89] FIG. 2 is a bottom perspective view of the morcellator according to the present invention. [Figure 90] FIG. 1 is a top perspective view of an energy morcellator and grasper according to the present invention. [Figure 91] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 92] 1 is a top perspective, partially see-through view of a guard according to the present invention; FIG. [Figure 93] FIG. 2 is a side view of a guard according to the present invention. [Figure 94] FIG. 2 is a partial perspective side view of a guard according to the present invention. [Figure 95] FIG. 2 is a side view of a guard according to the present invention. [Figure 96] FIG. 2 is a partial perspective plan view of a guard according to the present invention; [Figure 97] 1 is a cross-sectional plan view of a guard according to the present invention; [Figure 98] 1 is a partially perspective cross-sectional plan view of a guard according to the present invention; [Figure 99] FIG. 1 is a partial perspective side view of a retractor and guard according to the present invention. [Figure 100] FIG. 1 is a cross-sectional side view of a retractor and guard according to the present invention. [Figure 101] FIG. 1 is a cross-sectional top perspective view of a retractor and guard according to the present invention. [Figure 102] FIG. 1 is a cross-sectional top perspective view of a retractor and guard according to the present invention. [Figure 103] FIG. 1 is a top, partially transparent perspective view of a retractor and guard according to the present invention. [Figure 104] FIG. 2 is a side view of a guard according to the present invention. [Figure 105] FIG. 1 is a plan view of a guard according to the present invention. [Figure 106] FIG. 1 is a top perspective view of a retractor and guard according to the present invention. [Figure 107] FIG. 1 is a plan view of a retractor and guard according to the present invention. [Figure 108] FIG. 1 is a perspective view from below of a guard according to the present invention; [Figure 109A] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 109B] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 109C] FIG. 1 is a perspective view from below of a guard according to the present invention; [Figure 109D] FIG. 1 is a plan view of a guard according to the present invention. [Figure 109E] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 109F] FIG. 1 is a perspective view from below of a guard according to the present invention; [Figure 109G] FIG. 1 is a plan view of a guard according to the present invention. [Figure 110] FIG. 1 is a top perspective view of a guard according to the present invention. [Figure 111] FIG. 1 is a top perspective view of a two-piece guard according to the present invention. [Figure 112] FIG. 1 is a top perspective view of a blade guard according to the present invention. [Figure 113] 1 is a cross-sectional top perspective view of a blade guard according to the present invention; FIG. [Figure 114] 1 is a cross-sectional view of a blade receiver of a blade guard according to the present invention; [Figure 115] FIG. 2 is a perspective view from below of a blade according to the present invention; [Figure 116] 1 is a perspective view from above of a blade according to the present invention; [Figure 117] FIG. 1 is an exploded top perspective view of a blade guard assembly according to the present invention; [Figure 118] FIG. 1 is a top perspective view of a blade guard assembly according to the present invention; [Figure 119] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. [Figure 120] FIG. 1 is an exploded top perspective view of a blade guard assembly according to the present invention; [Figure 121] FIG. 1 is an exploded top perspective view of a blade guard assembly according to the present invention; [Figure 122] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. [Figure 123] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. [Figure 124] FIG. 2 is a bottom view of a blade guard assembly according to the present invention. [Figure 125] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. [Figure 126] FIG. 2 is a bottom perspective view of a blade guard assembly according to the present invention; [Figure 127] 1 is a side view of a containment bag according to the present invention. [Figure 128] FIG. 1 is a top perspective view of a tissue grasper and morcellator according to the present invention. [Figure 129] 1 is a cross-sectional side view of a handle of a tissue grasper according to the present invention. [Figure 130] 1 is a cross-sectional side view of the distal end of a tissue grasper according to the present invention. [Figure 131] 1 is a cross-sectional top perspective view of the distal end of a tissue grasper according to the present invention; FIG. [Figure 132] 1 is a cross-sectional side view of the distal end of a tissue grasper according to the present invention. [Figure 133] 1 is a top perspective view of a morcellator according to the present invention; FIG. [Figure 134] FIG. 2 is a bottom perspective view of the morcellator according to the present invention. [Figure 135A]1 is a side view of a containment bag according to the present invention. [Figure 135B] 1 is a plan view of a containment bag according to the present invention in a rolled-up configuration; FIG. [Figure 135C] FIG. 1 is an end view of a containment bag according to the present invention in a rolled up configuration. [Figure 135D] FIG. 1 is an end view of a containment bag according to the present invention. [Figure 136A] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 136B] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. [Figure 137A] 1 is a side view of a containment bag according to the present invention. [Figure 137B] 1 is a plan view of an open storage bag according to the present invention; FIG. [Figure 137C] 1 is a cross-sectional view of a ring of a containment bag according to the present invention. [Figure 138A] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 138B] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. [Figure 138C] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard wrapped around a bag ring according to the present invention. [Figure 139A] 1 is a side view of a containment bag according to the present invention. [Figure 139B] 1 is a plan view of an open storage bag according to the present invention; FIG. [Figure 139C] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 140A] 1 is a side view of a containment bag according to the present invention. [Figure 140B] 1 is a plan view of a storage bag according to the present invention; [Figure 141A] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 141B] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 141C]1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 141D] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. [Figure 142A] 1 is a side view of a containment bag according to the present invention. [Figure 142B] 142B-142B of FIG. 142A, a cross-sectional view of the storage bag according to the present invention. [Figure 142C] 1 is a cross-sectional view of a containment bag in an inflated state according to the present invention; [Figure 143A] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 143B] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 143C] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 143D] 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag and tissue guard according to the present invention. [Figure 144A] 1 is a side view of a containment bag according to the present invention. [Figure 144B] 144B-144B of FIG. 144A, a cross-sectional view of the storage bag according to the present invention. [Figure 144C] 1 is a cross-sectional view of a containment bag in an inflated state according to the present invention; [Figure 145A] 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. [Figure 145B] 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag according to the present invention. [Figure 145C] 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag pulled upward in accordance with the present invention. [Figure 145D] 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag and tissue guard according to the present invention. [Figure 146A] FIG. 2 is a side view of a guard according to the present invention. [Figure 146B]FIG. 1 is a bottom view of a guard according to the present invention. [Figure 147A] FIG. 1 is a plan view of a guard according to the present invention. [Figure 147B] FIG. 2 is a side view of a guard according to the present invention. [Figure 148A] FIG. 2 is a side view of a guard according to the present invention. [Figure 148B] FIG. 1 is a plan view of a guard according to the present invention. [Figure 149] 1 is a top perspective view of a shred and bag system according to the present invention; FIG. [Figure 150A] 1 is a top perspective view of a powered morcellator according to the present invention; FIG. [Figure 150B] 1 is a cross-sectional top perspective view of a powered morcellator according to the present invention; FIG. [Figure 150C] 1 is a cross-sectional view of a powered morcellator according to the present invention. [Figure 150D] 1 is a cross-sectional view of a powered morcellator according to the present invention. [Figure 151] 1 is a top perspective view of a specimen container according to the present invention; FIG. [Figure 152] 1 is a cross-sectional top perspective view of a bag tube and bag according to the present invention; FIG. [Figure 153A] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; [Figure 153B] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; [Figure 154A] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; [Figure 154B] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; [Figure 155A] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; [Figure 155B] 1 is a cross-sectional top perspective view of a grasper and containment bag according to the present invention in an open configuration; FIG. [Figure 155C] 1 is a cross-sectional top perspective view of a containment bag wrapped around a gripper in accordance with the present invention; FIG. [Figure 156A]1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; [Figure 156B] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; [Figure 157A] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; [Figure 157B] 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; [Figure 158A] FIG. 1 is a plan view of a guard according to the present invention. [Figure 158B] FIG. 10 is a side view of a guard attached to a morcellator shaft according to the present invention. [Figure 158C] FIG. 10 is a plan view of a guard attached to a morcellator shaft according to the present invention. [Figure 158D] FIG. 10 is a cross-sectional side view of a guard and containment bag attached to a morcellator shaft in accordance with the present invention. [Figure 158E] FIG. 1 is a cross-sectional plan view of a guard attached to a morcellator shaft in accordance with the present invention. [Figure 158F] FIG. 10 is a cross-sectional side view of a guard attached to a morcellator shaft in accordance with the present invention. [Figure 159] 1 is a cross-sectional top perspective view of a containment bag with a bag tube and a top opening according to the present invention; FIG. [Figure 160] 1 is a cross-sectional side view of a containment bag with a bag tube and a side opening according to the present invention. [Figure 161] 1 is a cross-sectional side view of a containment bag with a bag tube and a side opening according to the present invention. [Figure 162A] FIG. 1 is a side view of a tissue specimen in a containment bag according to the present invention. [Figure 162B] 1 is a cross-sectional side view of a tissue specimen in a containment bag attached to a morcellator in accordance with the present invention. [Figure 162C] FIG. 1 is a plan view of a containment bag attached to a morcellator according to the present invention. [Figure 163A] 1 is a cross-sectional side view of a containment bag and morsel system according to the present invention. [Figure 163B]1 is a cross-sectional side view of a body wall, a tissue specimen, and a containment bag and morcellator system according to the present invention. [Figure 163C] 1 is a cross-sectional side view of a body wall, tissue specimen within a containment bag and morcellator system according to the present invention. [Fig. 164] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 165] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 166] FIG. 2 is a plan view of the shield of the present invention. [Figure 167] 1 is a top plan view, partially in section, of a shield in a locked configuration in accordance with the present invention; [Figure 168] FIG. 1 is a bottom perspective view of the shield of the present invention. [Figure 169] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 170] FIG. 2 is a plan view of the shield of the present invention. [Figure 171] FIG. 1 is a top perspective view of a shield of the present invention. [Fig. 172] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 173] FIG. 2 is a partial plan view of a shield of the present invention. [Fig. 174] FIG. 2 is a partial cross-sectional plan view of a shield of the present invention. [Figure 175] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 176] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 177] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 178] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 179] FIG. 1 is a top perspective view of a shield of the present invention. [Figure 180] FIG. 1 is a partial top perspective view of a shield of the present invention. [Figure 181] FIG. 1 is a top perspective view of a shield of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0010] The following description is provided to enable one skilled in the art to make and use the surgical tools and practice the methods described herein, and relates to the best mode contemplated by the inventors for carrying out their invention. However, various modifications will remain apparent to those skilled in the art. These modifications are contemplated to fall within the scope of the present invention. It may be said that different embodiments or aspects of such embodiments are shown in the various figures and described throughout the specification. However, it should be noted that, although separately shown or described, each embodiment and its various aspects can be combined with one or more of the other embodiments and their various aspects, unless otherwise specified. The fact that each combination has not been explicitly described is solely to ensure readability of the specification.

[0011] Referring now to FIG. 1 , the closed morcellation procedure of the present invention is illustrated. 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 across the abdominal wall 10. Using laparoscopic techniques and instruments, such as trocars, laparoscopes, graspers, and scalpels, a single site opening can be made, the target tissue can be located, and the target tissue can be dissected away from surrounding tissue structures. Additional incisions or access sites can be used to insert instruments and scopes to facilitate the morcellation procedure. After the target tissue 16, such as at least a portion of the uterus in a hysterectomy procedure, is completely dissected, a specimen retrieval bag 18 is inserted through the opening 14 in the abdominal wall 10 and positioned within the body cavity 12. The bag 18 can be passed through a trocar or cannula positioned across the abdominal wall 10. The bag 18 is unfolded and oriented within the body cavity 12. The target tissue 16 is placed into the bag 18 through an opening 20 in the bag 18. Various types of bag 18 can be used. The bag 18 can be transparent so that its contents can be viewed from outside the bag 18 with a scope placed within the body cavity 12 through a secondary incision made across the abdominal wall 10. The contents of the bag 18 can be illuminated from outside the bag 18. The location of the target tissue 16 can also be viewed through the transparent bag 18, thereby confirming the progress of morcellation and its position and proximity to the opening 14. The secondary insertion method can also be used to observe the condition of the bag 18, ensuring that it is not tangled or twisted and to ensure that the specimen is not pulled along with it, which could result in accidental contact and cutting of the bag by the blade. Alternatively, an opaque bag 18 can be used. The material of the bag 18 is also important. Generally speaking, when made from plastic, the pouch is strong enough to withstand pulling and handling, has sufficient scratch resistance, is relatively thin and flexible, and is resistant to puncture and tearing. The pouch can be folded to reduce its size so that it can be inserted through a small incision / trocar, approximately at least 5 mm in diameter.Also, when opened, the bag is large enough to accommodate large pieces of tissue and extend through opening 14 to the surface of abdominal wall 10, creating a large enough working space within bag 18 for instruments, a scope, a morcellator 24, and a scalpel 26, as shown in Figure 1. Bag 18 has a tether or drawstring 22 configured to draw the opening closed and to open bag 18. Bag 18 is leak-proof and can withstand inflation pressure. Various examples of bags and devices for inserting, deploying, and / or retrieving bags to be provided in or integrated into a morcellation system configured so that the entire system, portions of the system, or a combination of the system and / or its components can accommodate an object to be morcellated in accordance with various embodiments of the present invention are described in U.S. patent application Ser. Nos. 08 / 540,795, filed Oct. 11, 1995; 11 / 549,701, filed Oct. 16, 2006; 11 / 549,971, filed Oct. 16, 2006; 12 / 902,055, filed Oct. 11, 2010; and 13 / 252,110, filed Oct. 3, 2011, the entire disclosures of which are incorporated by reference herein as if set forth in their entireties. Additional bag variations are described in detail below.

[0012] After the target tissue 16 is positioned within the pouch 18, the tether 22 is grasped manually or with a laparoscopic grasper, and at least a portion of the pouch 18 is pulled into the abdominal wall opening 14. Pulling the tether 22 closes the pouch opening 20. The initial incision can be enlarged to approximately 15-40 mm, after which the pouch 18 is pulled into the opening 14. If the target tissue 16 is too large to fit through the opening 14, the target tissue 16 will be located below the abdominal wall 10 within the body cavity 12. The remainder of the pouch 18, including its opening 20, is pulled into the abdominal wall opening 14 and extends through the opening 14 to the exterior of the patient's body and along the upper surface of the abdominal wall 10, as shown in FIG. 1. The pouch 18 can be rolled down and / or pulled taut across the surface of the abdominal wall 10 to maintain its position and allow for some tissue retraction at the opening 14.

[0013] The guard 28 is inserted through the opening 20 of the pouch 18. The guard 28 has a diameter that will hold the guard 28 in place within the incision / opening 14 when the guard is placed within the opening 14. The guard 28 can also retract tissue at the incision / opening and is therefore sometimes referred to as a retractor. One variation of the guard 28 is shown in Figures 2-6, and another variation is shown in Figures 7-10. The guard 28 has an inner surface 30 and an outer surface 32 that define sidewalls interconnected between a top 34 and a bottom 36. The inner surface 30 defines a central lumen 38 extending between the top 34 and the bottom 36. The inner surface 30 has a curved funnel-shaped portion located near the top 34, which may be convex or frusto-conical. The guard 28 has top and bottom circumferential flanges 40, 42 that extend radially outward to provide abutting surfaces against the upper and lower surfaces of the abdominal wall 10, respectively. The top flange 40 may include features such as holes for securing the guard 28 to the pouch 18, for example, by passing a tether 22 through it. The guard 28 has an overall length of approximately 2.5 inches (6.35 cm), although guards 28 of various lengths may be used depending on the thickness of the tissue wall 10 to be penetrated. Guards 28 of variable lengths, such as telescoping or telescoping guards 28, are within the scope of the present invention. The inner diameter of the guard 28 at its mid-length is approximately 1.3 inches (3.30 cm), and may be as small as approximately 0.6 inches (1.52 cm). The outer diameter of the guard 28 at the mid-length is approximately 1.6 inches (4.06 cm), which fits into the incision / opening so that the top circumferential flange 40 is held in place due to the larger overall diameter of the top circumferential flange 40 relative to the diameter of the guard 28 at the mid-length. The wall thickness at the mid-length is approximately 0.16 inches (4.06 mm), which may be as thick as about 0.3 inches (7.62 mm). The guard 28 is made of any polymer, such as KRATON® or polyethylene, although the guard may be made of any suitable material, including metal. The guard 28 may be flexible to allow the guard 28 to be slightly compressed to facilitate insertion through the opening 14 in the abdominal wall 10.The thickness of the guard 28 and / or the material of construction thereof are selected so that the guard 28 can withstand cutting and piercing forces from a blade, knife, scalpel, morcellator, etc. The guard 28 serves as a cutting plate or surface against which the target tissue rests for cutting prior to removal. The target tissue 16 is grasped with a laparoscopic grasper and drawn upward toward the opening 14. At least a portion of the target tissue 16 to be cut is then held in place at the guard 28 placement location somewhere along the length of the guard 28. A blade, e.g., a scalpel or morcellator, is then brought into contact with the portion of the target tissue to be cut at the guard 28 placement location and this portion of the target tissue is cut. The cut portion of the target tissue is then drawn through the opening 14 to a surface outside the patient's body, and a new section of the target tissue is brought into position along the guard 28 for cutting and removal. This process is repeated until the entire specimen is removed, either whole or partially, from the bag 18. The guard 28 serves as a protective measure for the bag 18. The surgeon is free to cut the target tissue with the guard 28 in place and against the guard's inner surface 30, thereby reducing the impact of a scalpel or morcellator cutting into the bag 18. The guard 28 not only protects the specimen retrieval bag 18 from accidental incision, but the guard 28 also protects the surrounding tissue, such as the abdominal wall, from accidental incision. The guard 28 maintains the integrity of the bag 18 and effectively maintains a closed incision system. The surgeon can quickly and safely reduce the specimen and remove it from the abdominal cavity.

[0014] Once the guard 28 is in place, the surgeon grasps the specimen 16 and pulls it through the incision as far as possible. The surgeon then begins morcellating the specimen 16 with the scalpel 26, cutting the specimen 16 to reduce its size. Ideally, the surgeon "hollows" or "skins" the specimen 16, preserving as much of it as possible. However, more than half of the time, the specimen 16 breaks into multiple pieces. During morcellation through the incision, the surgeon can maintain pneumoperitoneum within the abdominal cavity 12 so that the progress of the morcellation can be viewed laparoscopically through a side port located within the abdominal cavity 12 at a secondary site. The side port is located external to the pouch 18, allowing the surgeon to view through the transparent pouch or at the pouch itself, thereby ensuring the pouch maintains its integrity. Once the specimen 16 has been morselized, crushed, and reduced sufficiently to allow the remaining portions to pass through the incision, the guard 28 is removed, and the pouch 18 and its contents, including any debris generated during morselization, are withdrawn from the patient. The pouch 18 prevents any remaining debris from remaining within the abdominal cavity 12, maintaining a closed system, as opposed to traditional morselization procedures, which require the surgeon to return and painstakingly search for and collect scattered debris within the pelvic cavity to prevent it from potentially seeding new tumor sites. The surgeon may choose to perform a final view of the patient laparoscopically and then close the wound.

[0015] Although abdominal removal and morcellation have been described, the above procedure can also be performed via the vaginal introitus if the cervix has been removed. Following the same process, the pouch 18 is introduced and the specimen 16 is placed laparoscopically within the pouch 18. Rather than pulling the tether 22 through the abdominal wall opening 14, it is pulled through the vagina. In a similar manner, the specimen 16 rests at the bottom of the vagina while the pouch 18 advances through the vagina and opens outside the patient's body. The surgeon may roll down or pull the pouch 18 taut to maintain its position and provide some retraction. The surgeon may place a guard 28 transvaginally to protect the integrity of the pouch 18 and maintain a closed system, grasp and remove the specimen 16, and then morcellate it to reduce its size. Morcellation of the specimen is performed at and / or against the guard 28, thereby protecting the surrounding tissue and pouch from accidental incision. The surgeon can maintain pneumoperitoneum and monitor the progress of the morcellation laparoscopically. Once the specimen 16 has been morcellated, crushed, and reduced sufficiently to pass the remaining portion through the vagina, the guard 28 is removed, and the pouch 18 and its contents, including the debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents residual debris from being left behind in the abdominal cavity, thereby preventing harmful substances, such as cancer cells, from seeding the abdominal cavity and maintaining a closed system, as opposed to traditional morcellation procedures, which require the surgeon to return and painstakingly search for and collect debris scattered throughout the pelvic cavity. The surgeon may choose to perform a final laparoscopic view of the patient, and then close the vaginal cuff and abdominal incision.

[0016] In one variation shown in FIG. 11 , the guard 28 is configured to attach to a cap 44, such as a GELSEAL® cap manufactured by Applied Medical Resources Corporation of California. The cap 44 has a rigid ring 46 removably connectable 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 penetrable portion 50, which may be a gel configured to seal against instruments inserted therethrough and maintain a pneumoperitoneum within the abdominal cavity. FIGS. 12 and 13 show the cap 44 connected to the guard 28. A recall port 52 may be provided in the cap 44. The cap 44 may snap onto the guard 28 and be sealingly locked thereto by the lever lock 48, thereby maintaining a pneumoperitoneum. FIG. 14 shows a 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 to seal against the instrument when inserted. Multi-port cap 44 advantageously allows for insertion of a grasper, laparoscope, and / or morcellator through a single site.

[0017] 15-17 show another variation of guard 28, this variation including a balloon 56 at the distal end of guard 28. Balloon 56 is shown in an inflated configuration in FIG. 15. In the inflated configuration, balloon 56 extends radially outward to form a wide flange for securing to abdominal wall 10 within abdominal cavity 12, thereby making guard 28 difficult to accidentally remove through opening 14. FIG. 16 shows the balloon in a deflated configuration, which allows guard 28 to be easily inserted into and removed from opening 14. Guard 28 of FIGS. 15-17 can also be coupled to cap 44. Guard 28 can be constructed of any polymeric material, including polycarbonate or similar materials.

[0018] The funnel-shaped entry at the proximal end of the guard 28 was described above. In another variation, the funnel-shaped entry may be expanded radially outward to provide a larger surface area against which tissue can be cut. The flared proximal end also helps hold the pouch in place outside the patient's body and between the guard 28 and the tissue margin 10. In another variation, the guard 28 has a frusto-conical or curved flared distal end. The flared distal end may have an expanded, radially extending flange that spreads the pouch 18 laterally within the abdominal cavity. The flared distal end helps keep the pouch in an open position and away from contact with the specimen and distal entry into the guard 28, thereby protecting the pouch 18 from accidental contact with the blade. In the flared distal end variation 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 mid-length. In a flared proximal end variation of guard 28, the proximal diameter of the guard at the proximal opening is larger than the diameter of guard 28 at the mid-length. In yet another variation, guard 28 has a flared proximal end and a flared distal end that retains the advantages of the variations described above.

[0019] A method for tissue removal using guard 28 with cap 44 will now be described. After completing a laparoscopic hysterectomy or any other dissection, the specimen 16 described above is fully dissected free of surrounding tissue and awaits removal. The surgeon inserts a specimen bag 18, which may be transparent, into the pelvis and places the specimen 16 within the bag 18. Next, the surgeon grasps the tether 22 attached to the bag 18 with a laparoscopic grasper and pulls the bag 18 up and into the abdominal wall incision 14 where the trocar has already been placed. If necessary, the surgeon dilates the incision 14 by 15-25 mm before pulling the bag completely through. If the specimen 16 is too large to fit through opening 14, the specimen 16 is positioned inside the pelvic cavity, just below abdominal wall 10, while the remainder of the bag 18 is pulled through the incision and opened outside the patient's body, as shown in FIG. 1. The surgeon can roll down the pouch or pull it taut to maintain its position and provide some retraction. The surgeon then inserts guard 28 into the incision to protect pouch 18 and abdominal wall 10 during morcellation and to retract the incision. The integrity of the pouch is maintained and a closed system is maintained.

[0020] The guard 28 is placed into the opening 28 of the bag 18 and positioned within the incision so that the guard 28 extends across the tissue margin 10. The cap 44 is coupled to the guard 28. The cap 44 snaps onto the proximal top flange 40, and the lever 48 of the cap 44 is moved to the locked position to seal the cap 44 to the guard 28. The guard 28 may have a reinforcing wire 58 to maintain the shape and rigidity of the top flange 40. The wire 58 is visible in FIGS. 1, 5, 6, 10, and 12. With the cap 44 in place, the bag 18 may be insufflated. In one variation, only the bag 18 is insufflated to inflate it against the abdominal cavity 12. In another variation, both the bag 18 and the abdominal cavity 12 are insufflated. In another variation, both the bag 18 and the abdominal cavity 12 are insufflated, so that the pressure within the bag 18 is greater than the insufflation pressure in the abdominal cavity 12. Insufflation may be achieved via a trocar inserted through the cap 44 or via the insufflation port 52 in the cap 44. With the cap 44 in place, the powered morcellator 24 is inserted through the penetrable portion 50 of the cap 44 and into the interior of the pouch 18. Alternatively, if a multi-ported cap 44 is used, the morcellator 24 may be inserted through one of the ports 54. A surgical grasper is also inserted into the cap 44, either through the penetrable portion 50 or one of the ports 54, and the target tissue is grasped and pulled proximally toward the opening and into the central lumen 38 of the guard 28, where it is morcellated within the protective zone provided by the guard 28. As discussed above, the guard 28 protects the pouch 18 from puncture, thereby helping to maintain a closed morcellation system. The powered morcellator 24 is placed through the gel cap 44 to a depth that maintains the bladed distal end 60 of the powered morcellator 24 within the protective area or length of the central lumen 38 and guard 28. The grasper draws the target tissue toward the blade 60 for morcellation and removal. The removed tissue will travel through the central lumen of the powered morcellator 24.

[0021] Rather than placing the morcellator 24 through the pierceable portion 50 of the cap 44, a stabilizer is provided that cooperates with the bag 18 or guard 28 to help hold the morcellator 24 in place at a depth within a protective zone within the central lumen 38 of the guard 28. By maintaining the morcellator within the lumen 38 of the guard 28, the morcellator 24 is prevented from contacting the walls of the bag 18 during the procedure, thereby protecting the bag from accidental tearing. Variations in the stabilizer are described further below.

[0022] After positioning the morcellator 24 and cap 44, the surgeon may choose to insufflate the pouch 18 and abdominal cavity 12. The surgeon may observe the position of the morcellator 24 and target tissue 16 and the integrity of the pouch 18 to ensure that the pouch is not twisted or too close to the distal end 60 of the morcellator 24. Observation is performed with a laparoscope placed through a port 54 at the same incision site or through a secondary incision site serving as a side port. The specimen 16 is grasped by the tenaculum and pulled into the powered morcellator 24 to reduce its size. Ideally, the surgeon "hollows out" or "peels" the target tissue, keeping it as whole as possible. However, more than 50% of the time, the target tissue breaks into many small pieces. Once the specimen 16 has been morcellated sufficiently to pull the remaining tissue through the incision, the morcellator 24, gel cap 44 or stabilizer, and guard 28 retractor are removed, and the pouch 18 and its contents, including any debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents any remaining debris from being left behind in the abdominal cavity 12, maintaining a closed system, as opposed to traditional morcellation procedures, which require the surgeon to return and painstakingly search for and collect scattered debris in the pelvic cavity to prevent it from potentially seeding new tumor sites. The surgeon may choose to perform a final view of the patient laparoscopically and then close the wound.

[0023] While abdominal removal and morcellation have been described, the powered morcellation procedure described above can also be performed via a body orifice, such as the vagina. Following the same process, the pouch 18 is introduced and the specimen 16 is placed into the pouch 18 laparoscopically. Rather than pulling the tether 22 through the abdominal wall opening 14, the tether 22 is pulled through the vagina. In the same manner, the specimen 16 is positioned at the bottom of the vagina while the pouch 18 is advanced through the vagina and opened outside the patient's body. The surgeon may roll down or pull the pouch 18 taut to maintain its position and provide some retraction. The surgeon places the guard 28 through the pouch 18 via the vagina to protect the integrity of the pouch and maintain a closed system, then places the cap 44 over the guard 28 and places the powered morcellator 24 through the gel cap 44 or stabilizing cap. The surgeon then grasps the specimen 16 with the tenaculum and passes it through the powered morcellator 24 and out the vagina, thereby reducing the size of the specimen 16. The surgeon maintains pneumoperitoneum and monitors the progress of the morcellation laparoscopically. Once the specimen 16 has been morcellated sufficiently to retract the remaining material through the vagina, the morcellator 24, gel cap 44 or stabilizing cap, guard 28, and / or retractor are removed, and the pouch 18 and its contents, including any debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents any remaining debris from being left within the abdominal cavity 12, maintaining a closed morcellation system, as opposed to traditional morcellation procedures, which require the surgeon to return and painstakingly search for and collect debris scattered throughout the pelvic cavity. The surgeon may choose to perform a final laparoscopic view of the patient, and then close the vaginal cuff and abdominal incision.

[0024] 18 and 19, a retractor 62 is shown having a first ring 64 and a second ring 66 connected to one another by a flexible sidewall 68. The retractor 62 is described in detail in one or more of the patent documents incorporated by reference herein. The second ring 66 can be compressed and inserted through a small incision where it expands to form an anchoring means to the abdominal wall 10 within the abdominal cavity 12. The first ring 64 is positioned outside the patient's body above the abdominal cavity 10, where it can be lowered by rotating or inverting itself to retract and widen the abdominal wall opening 14. The retractor 62 can be employed in any of the variations described above. In use, the retractor 62 is inserted prior to insertion of the bag 18 into the body cavity or opening. In one variation, the first ring 64 has a larger diameter than the second ring 66, as shown in FIG. 19. The larger diameter of the first ring 64 relative to the second ring 66 allows for a larger working space to cut tissue. The sidewall 68 is made of a polyurethane laminate or similar material, including a nonwoven fabric that resists cutting the sidewall 68.

[0025] 20A and 20B show a modified retractor 62 configured within a pouch 70. The pouch 70 has a first ring 64 and a second ring 66 connected to one another by a flexible, substantially cylindrical sidewall 68. The opening at the second ring 66 is closed by a depending pouch portion forming the base 72 of the pouch 70. The pouch 70 is inserted and used in the same manner as described above for the pouch 18. The second ring 66 is compressed and delivered through a small incision into the abdominal cavity 12. The sidewall 68 is folded around the top ring 64 to retract and open the opening 14, with or without the use of a guard 24 connectable to the first ring 64 at the opening within the pouch 70. The specimen 16 is removed by manual or power morcellation in the same manner as described above. The first ring 64 is also connectable to a gel cap 44.

[0026] 21-24, a pouch 70 is shown that includes only the opening-forming first ring 64, a flexible, cylindrical sidewall 68, and a base 72. The first ring 64 is resilient and compressible to a collapsed, elongated configuration suitable for advancement through a small incision or through the lumen of a trocar. The arrows in FIG. 22 indicate the vertical collapse direction of the pouch 70. The collapsed pouch 70 is then easily compressed laterally and deployed within the abdominal cavity. The first ring 64 is compressed to form an elongated shape. The compressed pouch then assumes its original expanded shape. In the expanded configuration, the pouch 70 is easily oriented within the abdominal cavity 12. The collapsed pouch 70 conveniently lies flat within the abdominal cavity, and the pouch has two sides. In the collapsed configuration, the pouch 70 is not right-side up. The first ring 64 is preferably a two-ring bag 70, as either side can be used to place the specimen within the confines of the first ring 64. The first ring 64 serves as a circumferential guide for specimen placement and may be brightly colored to facilitate laparoscopic observation. After the specimen is placed within the perimeter of the first ring 64, the first ring 64 is grasped and lifted to place the specimen within the bag 70. The same is true for the two-ring bag 70 described above. As shown in FIGS. 23 and 24, the bag 70 may be twisted to form a spiral configuration to collapse or shorten the length of the bag. This feature is advantageous not only for insertion of the bag through a small incision, but also for lifting the specimen closer to the opening of the bag as the specimen is being morselized.

[0027] Referring now to FIG. 25, a guard 74 is shown that is configured for use with the retractor 62 shown in FIGS. 18 and 19 or the pouch 70 of FIGS. 20-24. The guard 74 has a rigid ring 76 with a plurality of inwardly extending flaps 78 that meet at a center, or form a central opening 80 as shown in FIG. 25. The flaps 78 are attached to the ring 76 so that they flex relative to the ring 76, thereby allowing the target tissue 16 to be removed past the flaps 78. The flaps 78 also flex distally to allow instruments to be inserted past the guard. The flaps 78 are made of the same material as the guard 28, e.g., polycarbonate, LDPE, HDPE, or a similar material, and therefore are sufficiently resilient and cut-resistant to resist penetration by blades, thereby protecting the retractor 62 or pouch 70. The guard 74 may consist of a single ring 76 with a flap 78, or it may be composed of two similar rings 76a, 76b with flaps 78a, 78b, respectively. The two rings 76a, 76b are connected to each other so that flap 78a is offset from flap 78b, forming a layered flap configuration that allows the flaps 78a, 78b to protect each other. The target tissue 16 is raised through the openings 80a, 80b, and when it is near the guard 76, the target tissue 16 is severed. The target tissue 16 can also be severed when positioned against the flaps 78a, 78b.

[0028] Referring now to FIG. 26, the guard 74 has an upstanding, flat peripheral wall 82 configured to snap into place under the first ring 64 or bladder 70 of the retractor 62, as shown in FIG. 29. The guard 74 may further include a flange 84 configured to snap into place with the first ring 64 or bladder 70 of the retractor 62, as shown in FIG. 28. FIG. 27 illustrates a rigid guard 74 without flaps. The rigid guard 74 of FIG. 27 provides a wide cutting surface that allows the target tissue to be cut against the cutting surface without flexing as much as a guard 74 with flexible flaps 78. The guard 74 may also include a funnel-shaped depending portion 86 that provides increased vertical protection for the bladder 70 / retractor 62 and / or wound. The guard 74 is positioned on top of the retractor 62 or bladder 70 and within the periphery of the first ring 64. The guard 74 is then snapped under the first ring 64 to join the guard 74 to the first ring 64. The guard 74 is also made of a material that resists penetration when being morcellated, helping to keep the bag 70 or retractor 62 in place. In other variations, the guard is configured to snap onto the ring.

[0029] Referring now to FIG. 30, a trocar 88 is shown having a first balloon 90 and a second balloon 92. The trocar 88 has a removable seal housing 94 with one or more seals that seal against an inserted instrument. The trocar 88 has a central lumen 96 extending through the seal housing 94 and the trocar 88. The lumen 96 is sized and shaped to receive the powered morcellator 24. The trocar 88 may also include an obturator (not shown) configured to penetrate the abdominal wall. The trocar 88 may be inserted through the gel cap 44 described above or directly through an abdominal incision. A bladder 18, 70 may be deployed through the lumen 86, and a specimen 16 may be inserted into the bladder 18, 70. The tether 22 of the bladder 18 or the first ring of the bladder 70 is pulled through the incision, and the trocar 88 is reinserted. The second balloon 92 is inflated. In the inflated configuration, the second balloon 92 extends laterally to push the pouches 18, 70 laterally and away from the distal end of the trocar 88, and away from the bladed distal end of the morcellator. The powered morcellator 24 is inserted into the lumen 96 of the trocar 88. The morcellator 24 may be prevented from extending beyond the distal end of the trocar 88 by a stop formed on the trocar 88 that abuts the morcellator 24. A tenacious hook is inserted into the lumen of the morcellator 24 to grasp and draw the tissue toward the morcellator. 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 hold the trocar 88 in place against the abdominal wall 10. FIG. 31 shows another trocar 88 with a seal housing 94 and an air insufflation port 98 for inflating at least one of the balloons 92 .

[0030] 32-39, the stabilizer 100 will now be described. The stabilizer 100 has a flange 102 configured to couple to the bag 18, 70 or the guard 28. The stabilizer 100 has a central portion 104 that defines a lumen 106 and houses a lock 108. The lumen 106 is sized and configured to receive the powered morcellator 24. Once inserted into the lumen 106, the height of the morcellator 24 relative to the abdominal wall can be adjusted, and the morcellator can then be locked in place with the lock 108. The lock 108 has an unlocking configuration that releases a lever 110 to allow the morcellator 24 to translate vertically within the lumen 106. The lock 108 also has a locking configuration that presses the lever 110 to lock the morcellator 24 against translation. The lock 108 acts to increase the frictional force against the shaft of the morcellator 24, holding the lock in place.

[0031] 40 and 41, a stabilizer 100 is shown coupled to a powered morcellator 24. The system of FIGS. 40 and 41 includes a ratchet drive mechanism including a toothed bar on the morcellator 24 configured to engage a pawl (not shown) in the central portion 104 of the stabilizer 100. A button 114 is provided on the stabilizer 100 to disengage or engage the pawl to unlock or lock the stabilizer 100 from the morcellator 24, freeing or preventing their relative vertical translation. The morcellator 24 includes an integrated scope and illuminator 116, an air insufflation port 118, and a mechanical drive connection 120 that rotates the morcellator blade 122. The stabilizer 100 includes an outwardly extending lower flange 102 for engaging a pouch, retractor, or guard, as described above. In one variation, the stabilizer 100 is configured to prevent actuation of the morsel 24 when the stabilizer pawl is located within a certain range of the toothed bar 112, thereby providing a safety shutoff mechanism so that the morsel 24 cannot be actuated when it is too far or beyond the range of the guard and therefore in a position that may cause accidental contact with the bag. Another variation of the stabilizer 100 is shown in Figures 42 and 43, where like numerals are used to indicate like parts. The stabilizer 100 has a different shape, with the pawl element 122 visible in Figure 43.

[0032] 44 and 45 show a bag 18 having a flexible ring 64 positioned at the tether 22 and opening 20. The bag material may be clear or opaque, and the ring 64 is compressible for insertion through a small incision. Wrapping a side wall 68 around the first ring 64 reduces the height of the bag, thus elevating the specimen closer to the opening, thereby making the specimen accessible for morcellation.

[0033] Figures 46 and 47 show a pouch deployment or deployment instrument 124 for the pouch 18 of Figure 47. The instrument 124 is insertable through a trocar. The pouch 18 has an opening 20, a tether 22, and a deployment cap 21.

[0034] 48 and 49 show another variation of the bag having a first ring 64, a second ring 66, a sidewall 68 between the first and second rings, and a base 72. The resilient second ring 66 located at the bottom of the bag 18 allows the bag to flare open when placed within the body cavity 12 and also helps prevent objects from sticking to the specimen 16. After the specimen is placed within the bag 18, the first ring 64 is pulled to the surface of the abdominal wall 10, as shown in FIG.

[0035] FIG. 50 shows the bag 18 having a first ring 64 made of nitinol that provides support to keep the bag 18 open within the abdominal cavity 12 while allowing for easy insertion through a small incision.

[0036] 50A-50D illustrate various embodiments of a bag 18 in an uncollapsed state or an expanded or partially expanded state. As shown, the bag 18 has a closed end 126 and at least one open end 128. The open end 128, according to various embodiments, has a tether or drawstring 130 that surrounds the open end 128 of the bag 18. Manipulation of the tether 130 closes the open end 128 of the bag 18. The illustrated bag 18 has a plurality of preformed folds 132 or predetermined deformation patterns in a wall 134 of the bag 18 between the closed end 126 and the open end 128 of the bag 18. According to various embodiments, the bag 18 is configured to provide a tendency for the bag 18 to collapse and flatten to a flattened state, with the open end 128 facing upward or toward the opening of the body cavity and having a maximum width, diameter, or opening dimension, and the closed end 126 facing away from the opening and configured to lie flat and stable along the body cavity, providing a minimum height. According to various embodiments, when a force is applied in one direction, the height of the walls 134 of the bag 18 increases to capture or surround the specimen within the bag 18. The folds 132 or deformation pattern ensure that this increase in height of the bag 18 occurs proportionally to the direction of the force. According to various embodiments, weight, specimen, or opposing force can be applied to the bag 18 to further assist in increasing the height of the bag 18, or particularly, in increasing the proportional height of the bag 18.

[0037] In one embodiment, the bag 18 is folded flat or accordion-shaped prior to deployment within a patient. Upon deployment, the bag 18 is flat with the open end 128 of the bag 18 positioned on the top and the closed end 126 positioned on the bottom. The closed end 126 is positioned on the bottom, for example, within a patient's body cavity. Thus, the open end 128 of the bag 18 remains open due to the pattern formed on the wall 134 of the bag 18 and thus does not need to be held open. Additionally, due to the pattern, the open end 128 is biased open and resists closing. This reduces the difficulty and time required to place a specimen on and / or within the bag.

[0038] The surgeon places the specimen on top of the bag 18, on or over the open end 128 of the bag 18. By pulling on the tether 130, the walls 134 of the bag 18 are pulled up and around the specimen, thereby containing the specimen. The opposing pulling forces on the tether 130 and the weight of the specimen on the bag 18 cause the deformation pattern along the walls 134 of the bag 18 to unfold or straighten. In one embodiment, the bottom or closed end 126 of the bag 18 has a weight or an attachable weight to provide a sufficient opposing force to unfold the walls 134 of the bag 18 when the tether 130 is pulled. In one embodiment, one or more tabs 136 or portions of the bag 18 around the open end 128 of the bag 18 are provided to unfold the walls 134 of the bag 18 or one or more folds 132 in the walls 134, even when the force of pulling the bag 18 toward an opening in the body cavity is applied.

[0039] In one embodiment, when the weight of the specimen pulls down on bag 18, this pulls the shorter sides of bag 18 downward, reducing the overall packing size. According to various embodiments, to compensate for or reduce the reduction in overall packing size, one or more tabs 136 are provided at open end 128 of bag 18 that are located on the flattened sides of bag 18 and prevent bag 18 from reducing its overall packing size. Thus, in one embodiment, when bag 18 is flattened, the distance along the edge of bag 18 is greater than the distance along the cross-section of bag 18. Tether 130, in one embodiment, is threaded through tab 136.

[0040] For a particular desired height and / or width of the bag 18, the patterns shown in FIGS. 50E and 50F are used to optimally form a wall pattern that ensures proper deployment and manipulation (e.g., straightening and containment). In one embodiment, the bag 18 is preformed with the pattern shown, and the bag 18 is then heated to maintain a flat and patterned state. A tether 130 is attached or threaded through tab 136 at the open end 128 of the bag 18. Thus, the heat, pressure, or preforming conditions that place the bag 18 in its initial flat, stabilized, and patterned state help maintain the deformed pattern, thereby collapsing or biasing the bag 18 into a deformed state upon placement within the body cavity. A downward force applied to the center of the bag 18 helps the folds 132 straighten or unfold, thereby expanding or lengthening the bag 18 and increasing its height to encase the subject. As shown, 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 one another and may exert equal force on the inner wall of the cylindrical deployment tool, thereby reducing the force required to deploy the bag 18.

[0041] According to various embodiments, the top or open end and bottom or closed end of the bag are twisted in alternating directions, thereby forming a spiral pattern on the bag's walls. The bag and / or the spiral is heated or compressed to retain these shapes. The spiral folds help keep the bag flat after insertion into the body. After a specimen is placed on the open end of the bag, pulling on the tether surrounding the open end of the bag causes the bag's walls to unfold or untwist. Thus, due to opposing pulling forces on the tether or open end of the bag and the weight of the specimen and / or attached or added weight at the closed end or bottom of the bag, the bag untwists and encases the specimen as it 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 ends into an open or expanded state to accept the specimen, increase the tendency of the bag to remain flat or unexpanded, or to provide weight to assist in the expansion of the bag or to provide stability in the placement of the bag or in accepting and capturing the specimen.

[0042] According to various embodiments, the top or open end and the bottom or closed end of the bag are collapsed directly toward each other. Wrinkles or creases in the bag wall between the open and closed ends of the bag retain these patterns / shapes upon heating or compression and help keep the bag flat after insertion into the body. After a specimen is placed on the open end of the bag, pulling on the tether surrounding the open end of the bag unwrinkles or straightens the bag wall. Thus, due to opposing pulling forces on the tether or open end of the bag and the weight of the specimen and / or attached or added weight at the closed end or bottom of the bag, the bag straightens to encase the specimen as it 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 ends into an open or expanded state to accept the specimen, increase the tendency of the bag to remain flat or unexpanded, or to provide weight to assist in the expansion of the bag or to provide stability in the placement of the bag or in accepting and capturing the specimen.

[0043] As shown in Figures 50G and 50H, the bag 18 can have a variety of upper, base and overall shapes, including but not limited to, cube, prism, cylinder, sphere, dodecahedron, hemisphere, cone, cuboid, polyhedron, etc., with one or more openings and various deformed wall patterns that allow the bag to tend to remain in a collapsed or substantially flat shape and to expand in a linear or controlled manner when manipulated to receive and encase a specimen.

[0044] Various examples of access systems to be included in or integrated into a morcellation system, where the entire access system, portions of the access system, or a combination of the access system and / or components thereof are arranged to provide channels and / or approximate areas in accordance with various embodiments of the present invention, are described in U.S. patent application Ser. Nos. 13 / 865,854, filed April 18, 2013; 61 / 880,641, filed September 20, 2013; 12 / 578,422, filed October 13, 2009; 61 / 104,963, filed October 13, 2008; 12 / 358,080, filed January 22, 2009; and 11 / 374,188, filed March 13, 2006. No. 11 / 683,821 filed March 8, 2007; No. 12 / 396,624 filed March 3, 2009; No. 14 / 209,161 filed March 13, 2014; No. 12 / 873,115 filed August 31, 2010; No. 12 / 840,989 filed July 21, 2010; Nos. 11 / 548,758, filed October 12, 2000; 10 / 516,198, filed November 30, 2004; and 10 / 666,579, filed September 17, 2003, all of which are incorporated by reference herein as if set forth herein.

[0045] 51-53, another variation of the guard or shield 200 of the present invention is shown. The guard 200 is generally spiral-shaped. The guard 200 has a first inner end 202 and a second outer end 204. The first and second ends 202, 204 are connected to one another by a central portion 206, also referred to as a leaf or band. The guard 200 has an apex end 212, also referred to as a trailing or proximal end, a bottom end 214, also referred to as a leading or distal end, and inner and outer surfaces 208, 210 connected to one another by the first inner and second outer ends 202, 204. The central portion 206 or band has a concave outer surface 210, and the inner surface 208 forms a uniform surface that is convex when viewed from the interior of the spiral. In one variation, the band recess is parabolic, with the inflection point located midway between the top end 212 and the bottom end 214, although the invention is not limited in this regard; the inflection point may be located anywhere between the top end 212 and the bottom end 214, or even coincident or nearly coincident with the top end 212 or the bottom end 214. The band 206 may not include a recess; the band 206 may simply be curved or straight along at least a portion of the guard 200 between the top end 212 and the bottom end 214. The guard 200 is shown as symmetrical, with the top end having the same outer diameter as the bottom end. In another variation, the guard 200 is asymmetrical in shape, with the top end having a larger or smaller diameter than the bottom end. The guard 200 is also vertically symmetrical, although the invention is not limited in this regard; the guard 200 may have a central axis that is angled with respect to a reference horizontal plane. The guard 200 has a spiral shape such that a portion of the band is curved and overlaps another portion of the band in a circular or elliptical manner. Specifically, at least a portion of the outer surface 210 of the band 200 overlaps and faces at least a portion of the inner surface of the band 200, such that a recess in one portion of the band 200 is located adjacent to or juxtaposed with a recess in another portion of the band, thereby telescoping and nesting one portion of the band within the other portion of the band.The spiral is shown as having a resting, mechanically unstressed configuration with one and a half turns having 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 guards having exactly 1.5 turns; a guard may have more or fewer turns as desired for a particular incision size, depending on its size, shape, and desired force distribution and function, e.g., retractor and / or retention function. A particular advantage of the spiral guard 200 is that its shape and size can be altered, expanded, or contracted. Essentially, the band can slide relative to itself, thereby forming a large diameter spiral configuration or a small diameter spiral configuration. The spiral guard 200 has a central lumen 216 formed by the spiral, which can also be expanded by expanding or unfolding the spiral. The size of the central lumen 216 can also be reduced by decreasing the size of the spiral by closing the spiral or sliding the band around itself into a tight curl, which creates many turns, or a loose curl, which creates a larger diameter with fewer turns. While the central lumen 216 is substantially circular in shape, the invention is not limited thereto; the central lumen 216 can also be oval or irregular in shape. Thus, the spiral shield 200 is adjustable when inserted into a patient's wound or incision, or into a pouch placed inside the patient's body as described above, along with other guards. Depending on the size of the incision, the spiral shield 200 can be adjusted larger or smaller by opening or closing the spiral, allowing the guard to curl around itself to create more turns and thereby conform accordingly to the wound opening or pouch. Furthermore, the spiral shield 200 can be molded with a predetermined bias for a particular rest or normal diametric position, shape, and size.For example, if an approximately 1-inch (2.54 cm) incision is made in a patient, the size of a spiral shield 200 having a resting diameter of approximately 2 inches (5.08 cm) can be reduced by twisting the spiral shield 200 on itself to increase its number of turns, thereby reducing its diameter. While in the contracted configuration, the spiral shield 200 is inserted into the 1-inch (2.54 cm) incision and then ejected. In response, because a bias is molded into the spiral shield 200, the spiral shield 200 tends toward its normal configuration and thus expands from its contracted configuration, advantageously retracting the incision while simultaneously sealing against or pressing against the incision and anything positioned between the shield 200 and the incision, such as a pouch in place relative to the patient. Alternatively, the shield 200 can advantageously be contracted under tissue force once inserted into the incision. The tissue force against the shield can reduce the diametrical size of the shield. Because the shield is adjustable, the size of the central opening or lumen 216 can be increased by opening the spiral for removal of larger specimens. This adjustability advantageously reduces strain on the surrounding tissue, keeps the incision site as small as possible, and reduces the risk of infection, while at the same time allowing for smaller or larger incision sizes to be made by opening the spiral as needed to withdraw the specimen from the body. In some cases, the size of the tissue to be removed is unpredictable, and this adjustability advantageously facilitates removal of extensive tissue specimens without creating difficulty for the physician.

[0046] The position of the spiral shield 200 is further advantageously held against the incision site or natural body orifice, e.g., the vagina, with the aid of a curvature or recess in the band. Specifically, the apex end 212 forms a top lip, also called a top flange, which extends circumferentially at least in part over the top surface of the tissue. The bottom end 214 forms a bottom lip or flange which extends circumferentially at least in part over the top surface of the tissue, abdominal wall, or surgical workspace within the patient's body cavity, advantageously retracting the tissue away from the cutting surface of the shield 200, which is generally the inner surface 208 of the band. Tissue is received against the outer surface 210 of the band, where it fits within the recess or curved shape of the outer surface 210, thereby holding the shield and containment bag in place, and the flange prevents the shield from sliding down or up into or out of the patient's body. Of course, the shield 200 is placed directly within the surgical incision / body opening or within any one or more of the containment pouches and wound retractors described above. Morcellation can proceed by any technique or manner chosen by the surgeon, including using the inner surface 208 of the shield 200 as a cutting plate, with a blade being used to cut tissue retracted by a grasper through or into the central lumen 216 against the cutting plate. Once the tissue to be morcellated is drawn up through the central lumen 216, it can be positioned against the inner surface 208 of the shield 200, and a blade or scalpel can be used to cut the tissue against the shield 200. The shield 200 is made of a suitable material, such as any polymer or metal. One suitable material is ultra-high molecular weight polyethylene plastic. Another suitable material is low-density linear polyethylene. The shielding material has a thickness optimized to protect the tissue without easily puncturing or cutting when the tissue is cut against the shielding material. Once morcellation is complete, the diameter of the spiral wound shield 200 can be reduced by rolling the shield onto itself into a compact configuration that allows for easy removal from the surgical site.Alternatively, the shield 200 may be removed by pulling the shield 200 vertically or along the longitudinal axis of the shield.

[0047] 52 and 53 show a core pin-shaped spiral wound shield 200 in a spiral-shaped forming mold 220. To manufacture the spiral wound shield 200 by injection molding, the shield 200 is formed on the spiral mold 220. Once the core pin of the mold 220 is unwound, the shield 200 can be forced into its functional spiral configuration by forcing one end in front of or behind an adjacent winding. Because the shield 200 is initially formed in a spiral shape and then spiraled, the shield 200 has some springback tension memory therein, which causes the shield 200 to attempt to assume a spiral shape rather than remaining perfectly spiraled. If the shield 200 has an undesirable and excessive amount of spring bias tension, an annealing process can be performed by placing the shield 200 in an oven at an appropriate temperature for an allotted time, and then removing it, thereby reducing or eliminating any residual tension in the shield 200. However, in one version of the shield 200, some residual tension is advantageously desired because the tendency of the shield 200 to expand along its longitudinal axis facilitates instrument removal from the incision site. A tab (not shown) can be formed on one end of the shield 200, e.g., the proximal, inner, or outer end, and / or a hole can be formed near one end of the shield, through which a drawstring can be attached so that the surgeon can pull the string or tab to easily remove the shield 200 from the incision site. The tab or hole can indicate directional preference for inserting the shield, so that helical tension can be utilized for instrument removal with the tab / hole positioned outside the patient and near the surgeon. In one version, the first inner end 202, which conforms to the inside of the winding, is provided with a tab or hole for this removal feature. During removal, pulling the inner end 202 vertically gradually stretches the bands of the shield out of the incision site.

[0048] As an alternative to injection molding, the spiral wound shield 200 may be manufactured from plastic sheet material, die cut, or thermoformed to the desired shape. Also, rather than injection molding the shield 200 into a spiral, the spiral wound shield 200 may be injection molded directly into the spiral shape.

[0049] 71A and 71B, shield 200 is shown in an expanded elongated configuration and a compressed or unexpanded configuration, respectively. The expanded configuration of shield 200 is also shown in detail in FIGS. 72-74. In the expanded configuration, shield 200 can be converted to a compressed configuration by overlapping inner surface 208 over outer surface 210. The compressed configuration of shield 200 is also shown in FIGS. 76-79. At least a portion of shield 200 overlaps itself in the unexpanded configuration, as clearly shown in FIGS. 78A-78C. FIG. 78C shows a portion of shield 200 fitting into a recess in outer surface 210 of an adjacent overlapping portion of shield 200. Shield 200 is adapted to be at least partially wrapped or curled about longitudinal axis 218. Shield 200 is adapted to be at least partially rolled or curled upon itself about longitudinal axis 218, such that one portion of shield 200 overlaps or is juxtaposed or in contact with another portion of shield 200. When in the unexpanded configuration of FIG. 71B , 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 having a reduced diameter or lateral dimension suitable for insertion into a wound or bodily opening. Shield 200 has a bias toward the relaxed or normal lateral configuration that the shield will tend to move toward after insertion into a wound or bodily opening, thereby exerting some retraction force on tissue as it expands from the compact configuration to the larger configuration, depending on the material used for shield 200 and the forces exerted by surrounding tissue in response to shield 200 in its inserted state. If the wound or body opening is tight, the shield 200 may not expand from its reduced lateral insertion configuration, or may expand slightly only in the lateral dimension as the shield tends toward its normal relaxed configuration, thereby unrolling slightly, or the shield 200 may fully expand to its normal relaxed configuration.

[0050] The vertically expanded configuration of shield 200 shown in Figure 71A results from shield 200 being molded onto a spiral mold 220. Shield 200 defines a longitudinal axis 218 along which a center of shield 200 is located. Shield 200 is made at least in part from a material that is biased toward the vertically expanded position. Shield 200 may be made from a shape memory material or may have a portion made from a shape memory material. When in the vertically compressed configuration, the bias toward the vertically expanded configuration does not result in the shield 200 springing into the vertically expanded configuration because the recesses in the outer surface form a top lip, also referred to as top flange 222, and a bottom lip, also referred to as bottom flange 224, such that at least a portion of top flange 222 abuts against the adjacent overlapping top flange 222 while in the compressed configuration, and at least a portion of bottom flange 224 abuts against the adjacent overlapping bottom flange 224 while in the compressed configuration, thereby preventing the vertically compressed configuration from easily flipping into the vertically expanded configuration. At least one of top flange 222 and bottom flange 224 serves as a stop that prevents the shield 200 from expanding from the compressed configuration to the expanded configuration. The bias toward the expanded configuration exerts some frictional force on the device itself, which helps to regulate the lateral or diametric expansion of the shield 200. When in the compressed configuration, the shield 200 may be rolled / curled about its longitudinal axis, thereby reducing its diametric or lateral dimensions, thereby reducing the dimensions of the shield 200 and reducing the diameter of the central lumen 216, thereby facilitating insertion through small, minimally invasive incisions or body openings.

[0051] FIG. 80 shows shield 200 in a relaxed or normal lateral configuration having approximately 1.25 times the circumference of the peripheral windings, and shows central lumen 216 with shield inner or lumen diameter 226 and shield diameter 228 or outer diameter, either of which serves as the lateral or diametric dimension for shield 200. FIG. 81 is a plan view of shield 200. In FIG. 81, shield 200 is in a compact configuration suitable for insertion into an incision / body opening, through which shield 200 is wound on itself in a tight roll. Shield 200 in FIG. 81 has approximately 2.25 or more times the circumference of the peripheral windings and has reduced lumen diameter 226 and shield diameter 228 relative to the relaxed or normal configuration of FIG. 80. While the overlapping portions of the shield 200 contact each other and act to slightly frictionally maintain the reduced lateral diameter position, the shield 200 tends to assume its normal configuration due to the lateral dimension bias toward its unstressed or relaxed radially normal configuration. The compact configuration with reduced lateral dimensions is adapted for proper insertion into a wound or body opening. From the compact configuration, the shield 200 expands from the reduced lateral dimension position to its normal unstressed lateral dimension configuration upon release when positioned outside the wound or body opening. This expansion in situ may be limited by forces exerted by tissue in response to forces exerted by the shield 200 in the inserted state. While the shield 200 has a central lumen 216 that is circular in shape and has a diameter, the invention is not limited thereto; variations include shields 200 having elongated lumens 216 with a length greater than a width, e.g., oval or elliptical lumens. Accordingly, the outer periphery of the shield 200 may or may not have a corresponding shape. In variations in which the outer periphery of the shield 200 has a shape that matches the shape of the central lumen 216, if the lumen 216 is circular, the outer periphery of the shield 200 is also circular, or if the central lumen 216 has an oval or elliptical shape, the outer periphery of the shield is also oval or elliptical.

[0052] As mentioned 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 vertically unexpanded configuration, the shield 200 is generally symmetrical about a plane perpendicular to the longitudinal axis 218, with the top flange 222 and the bottom flange 224 extending radially outward from the longitudinal axis 218 at approximately equal distances, as shown in FIG. 77. Referring to FIG. 79, a variation of the shield 200 is shown in which the shield 200 is not symmetrical about a plane perpendicular to the longitudinal axis 218. In FIG. 79, the top flange 222 extends radially outward from the longitudinal axis 218 at a greater distance than the bottom flange 224, which also extends radially outward from the longitudinal axis 218. The shield 200 thereby forms an enlarged top flange 222 relative to the bottom flange 224. The enlarged top flange 222 advantageously provides a large protective surface area for the surrounding tissue and / or containment pouch as well as a large cutting board surface for use by the surgeon when morcellating / reducing tissue.

[0053] Referring to FIG. 82 , a variation of the shield 200 is shown with a finger pull or tab 230. 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 apical end 212 of the shield 200, forming an extension adapted to be easily grasped by a user, either with the user's finger or with an instrument, such as a grasper. In one variation, the tab 230 has a hole 232 configured to provide an insertion location for an instrument or finger. In another variation, the hole 232 is not provided. The tab 230 is configured such that pulling the tab generally upward or in a proximal direction changes the shield 200 from the unexpanded configuration to the expanded configuration. As a result of the upward force applied at the first end 202 via the tab 230, the bottom flange 224 of the first end 202 disengages or disengages from the adjacent lower flange 224 of the shield 200, thereby moving the first end 202 away from the mated position with the overlapping curvature of the adjacent shield 200 portions. When the proximal end of the tab 230 is pulled upward, this causes vertical expansion of the shield 200, first resulting in the first inner end 202 disengaging from its unexpanded configuration and the remainder of the shield 200 gradually moving out of the mated apposition of the unexpanded configuration and into the spiral shape of the shield 200 in its expanded configuration. FIG. 82 shows the shield 200 in its unexpanded configuration and the tab 230 integrally formed therewith. In another variation, 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 variation, tab 230 has a tether attached to shield 200 , and in another variation, tab 230 is a tether and is not an extension of shield 200 .

[0054] 83 and 84 , a shield 200 is shown having a lock 234. The lock 234 is configured to lock the lateral or diametric dimension of the shield 200 while the shield 200 is in the unexpanded configuration. When the shield 200 is in place, forces from surrounding tissue may cause the lateral or diametric dimension of the shield 200 to be smaller than desired. While the shield 200 may have a relaxed, normal configuration while in the unexpanded configuration, the built-in bias of the shield 200 may not be sufficient to overcome the forces of the surrounding tissue or may not be to the surgeon's preference for a particular procedure, for a particular instrument to be passed through the central lumen 216, or for a particularly large specimen of target tissue. In either case, the lock 234 is configured to lock the shield 200 to hold its lateral or diametric dimension substantially fixed and, in particular, to prevent reduction in the lateral or diametric dimension due to forces from the surrounding tissue. For example, if the shield 200 is to be inserted into an incision or body opening that is relatively smaller than the lateral dimensions of the shield 200, the shield 200 is first collapsed to a compact configuration, such as that shown in FIG. 81 . While in the compacted configuration, the shield 200 is inserted into the wound or body opening. The force of the surrounding tissue in response to the shield 200 in the inserted state should be greater than the bias that tends to return the shield 200 to its normal, relaxed, unstressed configuration. In such cases, the surgeon may desire a larger central lumen 216 for the shield 200 or to retract the surrounding tissue. The surgeon then expands the shield 200 into the larger lateral or larger diameter configuration and locks this position with the lock 234 directed at the shield 200. In one variation, the lock 234 has a first notch 236 positioned a distance proximal to the first inner end 202 of the shield 200 and near the apical end 212 and a second notch 238 positioned a distance proximal to the second outer end 204 of the shield 200 and near the apical end 212.The notches 236, 238 are located near where one end 202 of the shield 200 overlaps the other end 204 of the shield 200 in the unexpanded configuration. The shield 200 is shown in the unlocked configuration in FIG. 83. To lock the shield 200, the shield 200 is expanded in the lateral dimension by spreading the shield 200 to form the large diameter central lumen 216. The first notch 236 overlaps the second notch 238 to lock the shield 200 in a fixed diametric / lateral dimension position, while the remainder of the shield 200 maintains some degree of circumferential overlap around the circumference of the shield 200. FIG. 84 shows the first notch 236 overlapping or interlocking with the second notch 238 in the locked configuration. While in the locked configuration, at least a portion of first end 202 is located outside at least a portion of second end 204, such that a portion of inner surface 208 of first notch 236 faces outer surface 210 of second notch 238. To unlock shield 200, notches 236, 238 are disengaged from one another.

[0055] As described above, the shield 200 can be inserted into a wound or body opening by rolling and / or compressing the shield 200 to a small diameter and then inserting it into the wound or body opening. Insertion of the shield 200 can be easily accomplished with common surgical instruments, such as clamps or graspers. Once inserted, the shield 200 naturally opens slightly, allowing tissue to flex and collapse out of its configuration. In one variation, the shield has a lock 234 that can lock the shield 200 at a slightly larger diameter, where it would naturally close. The lock 234 has notches 236, 238 along the outer edge of the shield 200 near the first and second ends 202, 204 where the coiled material overlaps. These notches 236, 238 overlap each other in the locked configuration, causing at least a portion of the inner end of the shield 200 to snap outwardly of the outer end of the shield 200. The exposed tabs of the lock 234 are pinched into an overlapping position providing a mechanical interlock.

[0056] 85 and 86, another variation of the lock 234 on the shield 200 is shown. The lock 234 has interlocking teeth. Specifically, a first set of external teeth 240 is formed on the outer surface 210 near the first inner end 202 of the shield 200, and a second set of internal teeth 242 is formed on the inner surface 208 near the second outer end 204 of the shield 200. The first set of external teeth 240 extend substantially vertically while positioned within a recess near the first inner end 202. The second set of internal teeth 242 extend substantially vertically while positioned within a recess near the second outer end 204. The external and internal teeth 240 and 242 may also be angled. In one variation, the teeth 240, 242 are angled to allow them to easily slide or rub against each other when moving from a reduced lateral dimension to an increased lateral dimension. The angle of the teeth locks the ends together and prevents the shield 200 from shrinking laterally due to tissue forces at the wound or opening. The external teeth 240 and internal teeth 242 are configured to interlock with each other to prevent reduction in the lateral dimension of the shield 200. A plurality of internal teeth 242 and a plurality of external teeth 240 are formed along at least a portion of the circumference near the first and second ends 202, 204 to allow the location at which the shield 200 is locked to be adjusted as needed, thereby fixing the lateral dimension as desired. While the teeth 240, 242 are shown positioned within a midline perpendicular to the longitudinal axis 218, the present invention may have teeth located anywhere along the vertical direction.

[0057] In another variation of the lock on the shield 200, the shield 200 includes a protrusion extending from the inner surface. The protrusion may be shaped like a hook and configured to mate with a notch or opening in an adjacent portion of the shield 200. In one variation, the protrusion 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.

[0058] The shield 200 protects tissue surrounding a wound or body opening from sharp objects, such as blades and morcellators, during surgery. The terms wound, body opening, incision, and body opening are used interchangeably herein. A wound is typically a minimally invasive incision made through the abdominal wall for laparoscopic or other types of surgery. In its expanded configuration, the shield 200 is a spiral spring comprised of a ribbon of material formed into a spiral that exerts an outward force when inserted into the wound or body opening. The shield 200 also retracts tissue within the wound or body opening and provides an opening across the abdominal wall or through the body opening via a central lumen 216, which is generally circular in shape when viewed along a longitudinal axis 218. In one variation of the shield 200, the shield 200 is made by winding a generally flat ribbon of material into a cylindrical or conical shape, rather than a curved shape. In another variation, the curved ribbon shield 200 has a C-shaped vertical profile when viewed from the side. The proximal and distal edges, also referred to as the apex 212 and base 214, are larger in diameter than the intermediate portion of the shield 200, which form the apex flange 222 and base flange 224, respectively. This C-shaped configuration advantageously contains tissue at the wound opening and provides an anchor-like fixation means, so that the shield 200 does not easily axially dislodge from the wound or body opening during normal use. In one variation, the C-shape is a parabola, as shown in FIG. 75. The apex of the parabola lies in a plane perpendicular to the longitudinal axis 218. In another variation, the apex lies between the apex 212 or base 214 and the vertical midline.

[0059] Removal of the shield 200 from the wound or body opening is accomplished by first disengaging the interlocking features 234, grasping the exposed inner corners of the shield 200, and curling it inward in the spiral direction of the material, then pulling it upward along the longitudinal axis and out of the wound or body opening. The shield 200 advantageously spirals into the helical configuration of its expanded configuration. The shield 200 can be withdrawn with the fingers or with a common surgical instrument, such as a clamp or grasper. One version of the shield 200 is made of a cut-resistant yet flexible plastic material. The material selection and thickness provide protective features. The shield 200 is flexible enough to be inserted and removed, yet rigid enough to remain secured and provide protection.

[0060] Shield 200 offers several advantageous features. One important feature provided by sheet 200 is that it protects surrounding tissue from sharp objects, such as blades, scalpels, and morcellators. Shield 200 also provides protection for the containment bag in which it is housed, preventing the containment bag from being pierced or cut by sharp objects, thereby maintaining containment of the biological specimen with reduced risk of leakage. Top flange 222 provides a broad, noble, or cutting-plate-like protection for the tissue, with the bag surface surrounding the wound or body opening. Top flange 222 overlies, covers, and / or protects the tissue margins and / or containment bag. The middle portion of shield 200 also shields the tissue at the wound or body opening and, if a containment bag is used, further protects the containment bag in which it is housed. Additionally, the intermediate section advantageously allows the surgeon to use the blade to reach deep to cut tissue specimens near the mid-horizontal plane perpendicular to or above the longitudinal axis, and to reach distally beyond the mid-plane of the shield 200 to cut tissue specimens, since the entire vertical length of the shield 200 provides protection to surrounding tissue and containment pouches.

[0061] Another advantage of the shield 200 is that it has anchoring features. The shield 200 is advantageously configured to anchor itself within the wound and body opening via a C-shaped design. The anchoring features dramatically ease and speed the morcellation procedure, as it eliminates the need for sutures or additional hands to hold the shield 200 in place during the typical procedure. Dual flanges (top and bottom 222, 224) are provided to anchor the shield 200, thereby capturing tissue or abdominal wall within the C-shaped recess. The shield has a distal anchoring member for positioning within the wound and a proximal anchoring member for positioning outside the wound opening. A single flange, whether a top or bottom flange, is also within the scope of the present invention. Additionally, while the top flange 222 and the bottom flange 224 are shown as extending along the entire circumference of the top end 212 and the bottom end 214, respectively, the present invention is not limited thereto, and one or more of the top and bottom flanges 222, 224 may extend around at least a portion of the circumference. In such a variation, finger-like extensions may be formed in place of the circumferential bottom flange 224. The fingers may be easily deflectable along the length to facilitate insertion and then spring radially outward to a resting position beneath the abdominal wall or other tissue structure or bodily opening. Additionally, the top flange 222 may extend radially outward a greater distance than the bottom flange 224, as shown in FIG. 79, or vice versa, thereby providing a wider cutting surface.

[0062] Additionally, shield 200 advantageously allows for easy insertion into and removal from a wound or body opening. Shield 200 has a vertically expanded configuration and a vertically unexpanded (unexpanded) configuration, which provide vertical flexibility to shield 200. This allows for easy removal of shield 200 by simply pulling one end of shield 200 proximally, causing shield 200 to spiral from its mated, unexpanded configuration out of adjacent and overlapping flanges and / or recesses and into an expanded, spiral configuration. Tabs, holes, and / or tethers 230 are provided to assist in grasping and pulling shield 200 vertically. Additionally, while in the mated or unexpanded configuration, shield 200 can be moved to a compact configuration by wrapping or curling shield 200 onto itself to form a small or tight circle and forming more convolutions around itself. Shield 200 advantageously moves laterally from the compacted configuration by releasing the compacted configuration, whereupon the shield assumes a normal, relaxed configuration having a relatively larger lateral dimension. An alternative, expanded configuration may also be provided by shield 200, in which a larger lateral or diametric position than the normal or relaxed configuration may be locked in place by locks 234 formed on shield 200. The lateral flexibility of shield 200 may reduce the lateral dimension, thereby facilitating easier insertion into a wound or body opening. Additionally, from the locked, increased diameter position, shield 200 may be unlocked and reduced in lateral dimension, thereby facilitating easier removal from a wound or body opening, by simply unlocking shield 200 and / or by unlocking shield 200 and then curling itself into a tighter configuration.

[0063] Shield 200 is also advantageously self-deploying. After curling shield 200 into a compacted lateral configuration, it is easily inserted into a wound or body opening and then released, whereupon the shield tends to expand in size due to its spring bias. This lateral spring-back action helps shield 200 automatically snap into the wound or body opening with little effort, while simultaneously providing protection and retraction to tissue and / or containment pouches, thereby keeping both away from sharp objects that may be encountered during a typical procedure.

[0064] Additionally, while in the vertically unexpanded configuration, shield 200 has an overall outer diameter that is C-shaped or hourglass-shaped, with the proximal end flaring radially outward from the longitudinal axis and the distal end of shield 200 flaring radially outward from the longitudinal axis, with the waist being the narrowest lateral dimension along a plane between the proximal and distal ends of the shield. The flare at the distal end of shield 200 advantageously provides a beveled or funnel-like shape that facilitates guiding and moving target tissue into and through shield 200.

[0065] The flexibility of the shield 200 allows it to be easily inserted, deployed, and removed, and it can become an anchor due to expansion. Flexibility is advantageously balanced against its ability to provide protection to surrounding tissue and / or the containment bag. When properly implemented, the protection provided by the shield 200 is sufficient for manual morcellation procedures while allowing the surgeon the freedom to use their own personal morcellation techniques. The shield 200 is inserted into the mouth of the containment bag; it can also be positioned within the neck of the containment bag or within the main container of the containment bag. The containment bag surrounds the shield 200, which is captured between the tissue / body opening and the shield 200. The shield 200 serves to retract the surrounding tissue as well as 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 proximal end of the bag is positioned proximal to the shield and over the patient's exterior, e.g., abdomen, thereby forming a blanket to help prevent contamination. The shield 200 is configured to hold the mouth of the containment bag in an accessible open configuration and to receive and support a manual or powered morcellation device.

[0066] In another variation, the shield 200 is adapted for insertion into the vaginal canal and is therefore elongated as shown. The shield 200 may further include a shape-memory portion to aid in deployment. The shield 200 allows for reliable and safe removal of endogenous samples and is easy to use, thereby reducing surgical time and costs. In combination with a containment bag, the shield 200 helps reduce the risk of contamination of healthy tissue with potentially malignant cells during tissue sampling and removal procedures.

[0067] Referring now to Figures 54-59, the pouch 310 of the present invention will be described. The pouch 310 has a single opening or mouth 312. A semi-rigid, compressible plastic ring 314 is coupled to the pouch 310 at or near the pouch's mouth 312. The ring 314 is compressible from a round or large configuration to an oval or small configuration, thereby allowing the pouch 310 to be inserted through a small incision. Once placed within the patient, the resilient ring 314 expands to its original, uncompressed, large configuration, thereby opening the mouth 312 of the pouch 310 along with it. When placed flat within the patient, the ring 314 clearly defines the mouth 312 of the pouch 310, and the opening 312 may be difficult to see under laparoscopic observation without the ring 314. In some cases, the opening 312 of the pouch 310 may be difficult to locate. Next, opening 312 must be oriented within the patient's body so that tissue is clearly placed within opening 312 and not beyond it. In the present invention, expanded ring 314, when placed on top of bag 310, allows tissue placed within ring 314 to settle within bag 310 when ring 314 is lifted toward the incision. An empty bag 310 lies flat on a flat surface, with ring 314 naturally dropping above bag 310. Resilient ring 314 allows bag 310 to remain open unassisted within the abdominal cavity, thereby facilitating tissue capture.

[0068] After the tissue sample is placed within the ring 314, the ring 314 is pulled toward the incision. A tether 316 is provided near the mouth 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 when the bag 310 is placed inside the patient. The tag 318 is also easily found inside the patient. The large tag 318 aids in quickly locating the tether 316 and pulling it, if necessary. The tether 316 may also be configured to tighten the bag 310 closed, preventing the contents of the bag 310 from spilling out. Alternatively, an additional drawstring may be provided connected to the bag 310 and positioned below or above the ring 314, such that the drawstring circumferentially closes the bag. Other ways of closing or sealing may also be provided, such as a pressure fit or zipper.

[0069] As the bladder 310 is pulled and positioned near the incision, it compresses the ring 314 from its expanded configuration to its compressed configuration, allowing the ring 314 to be pulled through a small incision. The ring 314 is compressed using a grasper or manually through the incision opening. After the ring 314 is pulled through the incision, enough of the bladder 310 is pulled with the ring so that it rests on and covers a portion of the patient's abdomen. Therefore, the bladder 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 bladder 310 outside the patient's body, the remainder of the bladder 310 and the tissue specimen remain inside the patient's body.

[0070] The cross section of the ring 314 may be circular, and this cross section may have a hollow center to provide flexibility. In one variation, the ring 314 may be oval, elongated, or elliptical in cross section. In the variation shown, the ring 314 has a shape resembling a figure eight or having two interlocking circular cross sections, resulting in a small valley 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 inverted on itself by inverting the ring 314 outward or inward and rolling the bag 310 onto itself. Rolling the ring 314 in the opposite direction allows the bag 310 to unroll from the ring 314. The elongated cross section of the ring 314 advantageously keeps the side walls of the bag 310 rolled onto the ring 314. The circular cross section allows the ring 314 to easily roll on itself, thereby unwinding the rolled sidewalls of the bag 310. The rolling of the ring 314 on itself pulls the bag 310 upward and brings the specimen within the bag 310 closer to the incision opening. The rolling action of the bag 310 reduces the bulk of the bag 310 while it is inside the patient's body, yet creates a precisely formed, taut apron outside the patient's body. If the bag 310 is retracted too tightly, the ring 314 may twist. The tissue specimen is then extracted from the bag 310 by morcellating it with a blade or electronic morcellator into a shape that can pass through a small incision and be removed from the bag 310. The rolling of the sidewalls 328 of the bag 310 on itself can form a roll 330 adjacent to the ring 314 to facilitate deployment, as shown in FIG. 59. Ring 314 is crushed so that the compressed length of ring 314 aligns with the length of roll 330 to allow for easy insertion.

[0071] With particular reference to Figures 55 and 56, ring 314 is formed from a single strip 322 of plastic that is shaped into a circle or other shape by joining the free ends together. In another variation, ring 314 is made from two or more pieces, such as two semicircles, that together form a circle of the same radius. The ends are not connected to each other and are held in a normal curved configuration within a sleeve at the mouth of bag 310. The multi-piece ring 314 facilitates compression of ring 314 into a compact configuration. 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 ring 314 is approximately 0.18 inches (4.57 mm).

[0072] With particular reference to Figures 57-59, the bag 310 is made from a single sheet 324 of material. The sheet 324 of material is folded lengthwise and heat-sealed at the sides, thereby forming a seam 326. The weakest point of any bag 310 is the area around the welded seam 326. As can be seen in Figure 57, the welded seam 326 is absent at the bottom of the bag 310, where forces are likely to be most concentrated during specimen removal, thereby providing the bag 310 with significant critical strength. Additionally, the material of the bag 310 is made from a transparent 4.2 mil Inzii® film, which allows the surgeon to see through the sides of the bag 310 during surgery. This ability to see through the bag 310 eliminates the need to puncture the sides of the bag 310 to achieve visualization. The film is elastic, providing good retraction for the bag 310. The bag 310 may also be made from U-5746 rip-stop 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. The bag 310 is approximately 16 inches (40.64 cm) long and 12 inches (30.48 cm) wide at the mouth 312. The bottom of the bag 310 forms an approximately 45° angle with the side wall 328 about 12.4 inches (31.50 cm) from the mouth 312. The bag 310 is approximately 0.2 inches (5.10 mm) thick, and at the seam 326, the bag 310 is approximately twice as thick. In another variation, the bag 310 is double-bagged, with one bag located inside the other to provide greater resistance to accidental punctures. In another variation, only the bottom portion of the bag 310 is reinforced with a double wall structure, making the bag 310 leak-proof and virus-resistant.

[0073] As described above, a shield may be provided for use in conjunction with the bag 310. After the bag 310 is placed within the patient and pulled through the incision, the shield is inserted into the mouth 312 of the containment bag 310. The shield is made of thick plastic and protects the plastic bag 310 from accidental cutting by the blade used by the surgeon to morsel the target tissue. The shield may also serve as a cutting plate, allowing the surgeon to cut the target tissue against the cutting plate, if necessary. The bag 310 may also be used with the retractor described above, in which case, as the bag 310 is pulled through the incision, the retractor is placed into the mouth 312 of the bag 310, retracting the tissue and bag 310 at the incision site, after which the shield is placed into the retractor to remove the specimen.

[0074] Referring to FIGS. 60-63, a bag introducer or fork 410 is used to introduce a containment bag 310 into a patient's body cavity through a small incision. The introducer 410 facilitates 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 to form a substantially fork-like configuration. The branches 418, 420 are of equal length. The branches 418, 420 can have any suitable cross-section, and the branches are spaced a sufficient distance from one another. The branches 418, 420 are made of stainless steel and are connected to an injection-molded plastic or metal handle 416, as shown in FIG. 60. In this design, a steel rod with tines 418, 420 is inserted into and connected to an injection molded handle 416, which allows for a fork 410 with a small profile, but is expensive and time-consuming to manufacture. In Figure 61, the fork 410 is made from a single piece of material, where both the handle 416 and tines 418, 420 are injection molded to form a one-piece structure. This design is the easiest and least expensive to manufacture, at the cost of a large profile and a weaker design.

[0075] In use, with particular reference to FIGS. 62 and 63 , the bottom of the containment bag 310 is placed between the prongs 418, 420, with the tether 316 and tag 318 positioned near the handle 416. The bottom edge of the bag 310 is folded over the prongs 418, 420, with the prongs 418, 420 extending slightly beyond the ends of the bag 310. Thus, the prongs 418, 420 are slightly longer than the width of the bag 310. The handle 416 is grasped and turned, allowing the bag 310 to be evenly rolled into the tubular roll 330 until resistance is felt. The bag 310 is reduced to the smallest size possible for introduction into the body region. The elastic ring 314 is squeezed to roll the bag 310 until the bag 310 is taut and positioned adjacent to the ring 314. With visualization enabled, insert the sack 310 and fork 410 combination through the incision so that the opening 312 of the ring 314 is positioned upward. Insert the sack 310 until it is approximately three-quarters of the way into the incision. Rotate the fork 410 backward to slightly loosen the sack 310. Loosening the sack 310 reduces tension on the sack, thereby allowing tissue to more easily fall into the sack 310. The fork 410 allows for easier deployment of the sack 310 while controlling how tightly the sack 310 is rolled and the orientation of the ring opening 312 during insertion. If the sack 310 is rolled too tightly, tissue will not easily fall into the sack 310 even if the ring 314 is lifted inside the patient. Rotating the introducer 410 backward before removing it facilitates insertion of tissue into the sack 310.

[0076] The fork 410 is released 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 within the abdominal cavity, an access port and scope are placed and the body cavity is insufflated. The bag 310 is positioned so that the ring 314 is on top of the bag 310. An access port can be placed within the same incision or a secondary incision. With visualization available, the tissue to be morcellated and removed from the patient is placed within the bag 310. A lateral access port can be used to visualize and confirm that tissue is present within the bag 310. The access port can be removed and removal of the bag 310 outside the patient's body can begin. The secondary access port does not need to be removed and can be used to continue monitoring the removal and next morcellation. The tag 318 can be located outside the patient's body. The tag is pulled to pull the bag 310 up toward the incision. If the tag 318 is present within the body cavity, a grasper can be used to grasp the tag 318 under visualization through the access port. The tether 316 and tag 318 are pulled up through the incision until a portion of the ring 314 is present through the incision. The ring 314 is pulled until the entire ring 314 is outside the incision. The bag 310 is retracted by rolling / flipping the ring 314 onto itself, wrapping the bag 310 around the ring 314. This rolling of the ring 314 not only slightly retracts the tissue, but also reduces the bulk of the bag 310 within the patient, thereby drawing the tissue closer to the surface within the patient's body. The tissue is then morselized.

[0077] Alternatively, a retractor with a central lumen is placed into the mouth of the bag 310 at the incision, and the tissue is retracted along with the bag 310, thereby widening the opening, and then the tissue is morcellated with the bag 310 in place. A retractor with a central lumen is placed into the mouth of the bag 310 at the incision, and the shield described above is prepared and used in conjunction with the bag 310 and retractor. The shield is placed into the central lumen of the retractor. Of course, the shield can be used without a retractor. If a retractor is not used, the shield is placed into the mouth 312 of the bag 310 at the incision. The shield is inserted into the mouth 312 of the containment bag 310 after the bag 310 is placed inside the patient and pulled through the incision. The shield is made of thick plastic, which protects the plastic bag 310 from accidental cutting by the blade used by the surgeon to morcellate the target tissue. The shield may also serve as a cutting plate, allowing the surgeon to cut the target tissue against the cutting plate if necessary. The shield itself may also function as a retractor, with a first, reduced dimension and a second, enlarged dimension. The second, enlarged dimension serves to retract the tissue.

[0078] When a retractor is used within the pouch 310, the retractor advantageously not only retracts tissue but also retracts a portion of the pouch, thereby keeping the pouch away from the morcellation blade and protecting it from nicks and perforations. A typical retractor has a top ring and a bottom ring with a flexible sidewall connected between them. The bottom ring is inserted through the incision and is located within the patient, while the top ring of the retractor is located above the patient. The top ring is rolled / inverted onto itself like a pouch, drawing the lower ring of the retractor closer and bringing the sidewalls into a taut relationship between the rings. The lower ring of the retractor advantageously retracts the portion of the pouch 310 within the patient, preventing potential damage caused by puncture and tearing by the blade.

[0079] The tissue is morselized in the manner desired by the surgeon. Generally, a small portion of the target tissue is extracted from the patient's body while the majority of the target tissue remains within the patient. The surgeon then takes the blade and makes approximately a 180° or 360° circumferential cut around the circumference of the protruding tissue without severing the protruding tissue from the remainder of the target tissue. By keeping the protruding tissue intact while the larger pieces remain within the patient, the surgeon can continue to grasp the tissue without losing track of it within the pouch. The surgeon gradually pulls the grasped tissue out of the patient, making periodic circumferential cuts of any size to extract more of the tissue until the entire piece of target tissue is removed. The result is a single, elongated piece of removed target tissue, rather than multiple small pieces. If not removed as a single piece, the target tissue is removed in several small pieces and in a more controlled manner. The pouch 310 can be further retracted between morsels, thereby bringing the specimen closer to the surface. Once the tissue remaining within the pouch 310 is small enough to fit through the incision easily, the pouch 310 is completely removed.

[0080] 64 and 65, another shield 510 of the present invention is shown. The shield 510 has a first ring 512 located at a proximal end 514 and a second ring 516 located at a distal end 518. The rings 512, 516 are substantially parallel to one another and connected to one another by a sidewall 520. The sidewall 520 is a woven sheath material that can be made of a soft fiber or polymer. This material can be Kevlar®, Dyneema®, rip-stop nylon, or a polymer blend material. The sidewall 520 is heat-sealed or otherwise bonded to the rings 512, 516. The first and second rings 512, 516 are semi-rigid and compressible between a normal, high-profile, large configuration and a compressed, low-profile, elongated configuration. The rings 512, 516 are generally circular in their normal configuration, but may also be oval. The rings 512, 516 can be compressed from a round or large configuration to an oval or small configuration, allowing the shield 510 to be inserted into a small incision, particularly into the opening of a containment bag to protect the shield. In one variation, only the second ring 516 is compressible for insertion into the incision, and the first ring 512 is rigid so that the first ring 512 is positioned externally or proximally relative to the patient's body. The rigid proximal first ring 512 can be large and wide to serve as a large shield or cutting plate for morcellation. The second or distally positioned ring 516 is flexible and suitable for being compressed and easily inserted into a bag, and can be slightly smaller in diameter than the first ring 512.

[0081] One or more of the rings 512, 516 may have a circular cross section. The rings 512, 516 have a hollow center to provide flexibility. In one variation, the rings 512, 516 have an oval, elongated, or elliptical cross section with a hollow center. In another variation, the rings 512, 516 have a shape resembling a figure eight with two interlocking circular cross sections, resulting in a small valley between the circles, as shown in FIGS. 55A and 55B. Generally speaking, the cross section of the rings 512, 516 has a length greater than its width. This elongated cross section allows each ring 512, 516 to be turned or inverted on its own by inverting the ring 512, 516 outward or inward and wrapping the side wall 520 around the ring 512, 516. In one variation, only the first or proximal ring 512 is configured to wrap around the side wall 520. In another variation, both rings 512, 516 are configured to wrap around 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 can be wrapped. The shield 510 is inserted by compressing one or more of the rings 512, 516. While both rings 512, 516 can be compressed to a low-profile configuration that allows for easy insertion through the incision, generally speaking, only the distal ring needs to be compressed; 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. One or more of the rings 512, 516 configured for wrapping can be wrapped in the opposite direction to increase the length of the side wall 520. When one of the rings 512, 516 is rolled, the length of the side wall 520 is rolled onto the ring, thereby shortening the length of the shield 510. The elongated cross-section of the ring advantageously keeps the side wall 520 rolled around the ring. If the cross-section were circular, the ring could be easily rolled in the field, thereby expanding the rolled side wall 520. The rolling of the ring onto itself pulls the opposite ring upward toward it.

[0082] The rings 512, 516 are made from a single, elongated plastic piece that is formed into a circle or other shape by joining the free ends together. In another variation, the rings 512, 516 are made from two or more pieces, such as two semicircles that together form the circle for each ring. The ends are not connected to each other and are held in a normal curved configuration. The multi-piece rings allow the rings to be easily compressed into a small, low-profile configuration. The rings are 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). Figure 65 shows the shield 510 retracted by placing the proximally positioned first ring 512 within the pouch 310 and rotating it on itself until 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 sidewall 520 protects the pouch 310. Retraction by rolling the proximal first ring 512 advantageously lengthens the incision. The resulting larger incision significantly facilitates manual morcellation. In another variation, the shield 510 is not configured to allow for rolling one or more of the rings 512, 516 to reduce the length of the shield 510 and its sidewalls, which are made of protective material.

[0083] 66 and 67, an alternative shield 510 of the present invention is shown. The shield 510 is similar to the shield of FIGS. 64 and 65 in that it has a first ring 512 located at a proximal end 514 and a second ring 516 located at a distal end 518, which rings are connected to one another by a flexible sidewall 520. The modified sidewall 520 shown in FIGS. 66 and 67 has a first layer 522 and a second layer 524, which are shown separated and laid flat in FIG. 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 juxtaposed with the second layer 524 to form a lantern-shaped sidewall 520, with the slits 526 in the first layer 522 and the slits 528 in the second layer 524 offset from one another so that they do not join to form a breach through the shield 510. Instead, the overlapping layers 522, 524 with the 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 is easily bent yet cut-resistant. The layers 522, 524 facilitate insertion yet are flexible enough to retract upon placement within a pouch located within an incision, with or without everting the rings 512, 516 as described above. In another variation, the slits 526, 528 are not perpendicular to the top and bottom edges of the 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 sidewalls 520 are made of a protective material.

[0084] 68-70, a shield 530 according to another variation of the present invention is shown. The shield 530 is made of a flexible or semi-rigid plastic. The shield 530 has a substantially flat flange 532 with an opening 534 in its middle. Looking from the opening 534, a plurality of slits 536 extend outwardly from the periphery of the opening 534 into the flange 532, thereby increasing flexibility at the corner intersection. The flange 532 is sized and shaped to fit within a retractor when the retractor is in use. Specifically, the flange 532 snaps under the top ring of the retractor to help hold the shield 530 in place.

[0085] 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 the proximal end to an opening 540 at the distal end. The tubular section 538 may further have a plurality of slits 542 extending upward from the distal opening 540. The shield 530 further has two fingers or elongated extensions 544 that extend downward from the tubular section 538 at an oblique angle that constitutes a first configuration for the fingers 544. The fingers 544 have a second configuration, which is a reduced or compressed configuration as shown in FIG. 69 , in which the fingers 544 are pressed together or folded back toward the longitudinal axis to assume a lateral dimension that is the same as or smaller than the lateral dimension of the central tubular section 538. The reduced configuration facilitates insertion of the shield 530 into an incision or body opening. Upon insertion across the abdominal wall, as shown in FIG. 70, fingers 544 are advantageously configured to spring back into a first configuration in which fingers 544 splay outward at an angle. In this first configuration, within an incision, fingers 544 advantageously not only retract tissue but also retract a pouch (not shown) into which they are inserted. Slits 542 provide additional flexibility to the distal end of central portion 538, allowing central portion 538 to assume a narrower configuration upon placement in an incision and then spring back to its normal configuration, which aids in pouch and tissue retraction. The height of flange 532 and central portion 538 is approximately 0.5 to 2.0 inches (1.27 to 5.08 cm), and shield 530 is made of HDPE, LDPE, HYTREL®, or other suitable polymer or metal. Additionally, the shield 530 may have three or more fingers 544 .

[0086] 87-90, a morcellation system 600 is shown. The morcellation system 600 is an instrument that allows for the safe en bloc removal of bodily tissue or organs through a restricted surgical opening. The morcellation system 600 is a substantially closed system that prevents contamination of surrounding tissue with potentially cancerous cells present in the target tissue during the morcellation and extraction procedure. The morcellation system 600 includes a morcellator 602, a containment bag (not shown), a tenaculum 606, and a shield 608.

[0087] The containment bag may be any of the bag embodiments described herein. Generally, the containment bag comprises a polymeric pouch with a mouth or opening attached to a ring that surrounds the mouth or opening. The ring is flexible and configured to be biased into an open configuration, such 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 to a low-profile state, allowing it to be easily inserted into a wound or body opening. The ring remains open, allowing the bag to be retracted by rotating the ring on itself and wrapping the sidewall of the bag around the ring. A tether is attached to the proximal end of the ring or bag. The tether has an attached tag that can be grasped with a surgical instrument.

[0088] The morcellator system 600 further includes a morcellator 602. The morcellator 602 is a powered morcellator. The morcellator 602 has a cutting ring or annular blade 610 with a sharp distal end adapted to cut tissue. The annular blade 610 is attached to a hollow barrel 612. The barrel 612 is coupled by gears to a pneumatic or electric motor (not shown) for rotation about its longitudinal axis. The morcellator 602 has an inner barrel 614 with a flared or funnel-shaped proximal end coupled to a morcellator housing 616. A distal end 620 of the inner barrel 614 extends to a location proximal to the annular blade 610. The inner barrel 614 defines a working channel or central lumen 618 of the morcellator 602. The inner barrel 614 prevents tissue drawn into the central channel 618 from rotating within the morcellator 602. The morcellator 602 further includes an outer barrel 622. The outer barrel 622 coaxially surrounds the cutting barrel 612. The outer barrel 622 has a proximal end that is connected to or forms part of the housing 616. The distal end 624 of the outer barrel extends to a location proximal to the distal end of the blade 610. The outer barrel 622 has an extension 626 located at the distal end 624 of the outer barrel 622. The extension 626 extends slightly beyond the distal end of the blade 610. The extension 626 prevents coring of the morcellated specimen.

[0089] The morcellation system 600 further includes a shield 608. The shield 608 may be any of the shields described herein, and in one variation, 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 extended configuration. The shield 608 is collapsible to a low-profile unextended configuration. The shield 608 can be repeatedly moved from the extended configuration to the unextended configuration and from the unextended configuration to the extended configuration as needed. The shield 608 is a spiral-shaped soft plastic band in the extended configuration. 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 top or proximal end 628 and a bottom 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 while in the unexpanded 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 and by first and second ends. The outer surface 634 is concave, and the inner surface 632 forms a conforming 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 includes a central lumen 636. When in the low-profile, unexpanded configuration, the shield 608 can be laterally reduced in size so that it has a relatively small lateral dimension. As described above, while in the low-profile, unexpanded configuration, the shield 608 has a relaxed, normal position with a first lateral or diametric dimension. The shield 608 also has a reduced configuration while in the low-profile, unexpanded configuration having a second lateral or diametric dimension. The second lateral or diametric dimension is smaller than the first lateral or diametric dimension. The collapsed configuration when in the unexpanded configuration is achieved by curling the shield 608 onto itself into a tighter and smaller configuration. This curling action reduces the size of the central lumen 636. This collapsed configuration is held securely 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 onto itself into a contracted configuration. Then, upon insertion into the incision or body opening, the shield 608 is released to expand from the tightly curled state toward a relaxed, normal position having a larger lateral dimension. However, forces from surrounding tissue can prevent the shield 608 from reaching the first lateral or diametric dimension; thus, the shield 608 can reach a dimension equal to the second lateral dimension, equal to the first lateral dimension, or have any dimension between the first and second lateral dimensions. Furthermore, the shield 608 can expand into an expanded configuration with a third lateral or diametric dimension. The third lateral or diametric dimension is larger than the first lateral or diametric dimension. The expanded configuration can be locked into place on the shield 608 by any of the locks described herein, which secure the position and / or lateral or diametric dimensions of the shield 608. The expanded configuration can serve to retract tissue to enlarge a body orifice or wound opening. The contracted configuration as well as the relaxed normal configuration and any position between the contracted and expanded configurations can serve to retract tissue to hold open wounds and body orifices while providing a working channel through the central lumen 636.

[0090] 87 and 88 , the morcellator 602 is shown inserted into the central lumen 636 of the shield 608. The distal end of the morcellator housing 616 abuts the proximal end 628 of the shield 608. The length 640 of the morcellator 602, including the blade barrel 612, inner barrel 614, and outer barrel 622, extending downwardly from the housing 616, is approximately equal to the length 638 of the shield 608. In one variation, the length 638 of the shield 608 is shorter than the extension 626 that protrudes from the outer barrel 622. FIG. 87 shows the extension 626 extending beyond the length of the shield 608. In such a variation, the distal end of the shield 608 is located just proximal to the extension 626. In another variation, the length 638 of the shield 608 is equal to the distal end of the annular blade 610. In another variation, the length 638 of the shield 608 extends slightly distally beyond the blade 610. In another variation, the length 638 of the shield 608 is distal to the extension 626. The length 638 of the shield 608 is adapted to encase the depending portion of the morcellator 602, and in particular the blade 610. By encasing the blade 610, the shield 608 protects the blade 610 from accidental contact with surrounding tissue and the containment bag.

[0091] In use, the tissue containment bag is placed through a small abdominal incision or a small body orifice or opening. This is accomplished by compressing the bag's flexible ring into a low-profile configuration and inserting the bag through the small incision / opening. The flexible ring springs open within the body cavity and expands the mouth of the bag, facilitating placement of the severed target tissue piece within the bag. The target tissue is placed into the bag while it is positioned within the abdominal cavity of the body. A retractor may be used and placed within the incision. The bag's tether is then used to pull the bag's ring through the incision. The bag's ring is rolled onto itself, wrapping the bag's sidewalls around the ring, thereby reducing the length and size of the bag and drawing the specimen within the bag toward the incision / opening. The specimen within the bag is visualized with the naked eye near the mouth of the bag. The shield 608 is rotated while outside the patient's body to minimize its size by rolling or curling onto itself into a compact configuration. While in the contracted configuration, the shield 608 is placed into a pouch within the incision / opening, and the shield expands on itself or diametrically to reverse the rotation of the shield 608, thereby maximizing the incision / opening. The expanded position may be secured by a lock of the type described herein. The shield 608 is stretched to its larger size. The C-shaped outer surface 634 of the shield 608 anchors well within the incision, thereby fitting the abdominal wall within the recess of the "C." The tenacious hook 606 is advanced through the central lumen 618 of the morcellator 602 and is used to grasp the target tissue while visualizing it with the naked eye. Once the tissue is properly grasped, the tissue is held by the tenacious hook 606 and the morcellator 602 is moved or slid down the length of the tenacious hook 606 until the depending portion of the morcellator 602, including the blade barrel 612, inner barrel 614, and outer barrel 622, passes through the central lumen 636 of the shield 608, until the distal end of the morcellator housing 616 abuts the proximal end 628 of the shield 608. The tenacious hook 606 can be pulled proximally so that the specimen contacts the blade 610 of the morcellator 602. The morcellator 602 is actuated, causing the blade barrel 612 to rotate at high speed. With the specimen still grasped, the tenacious hook is pulled proximally.The tenacious hooks are used to draw the gripped tissue into the cutting blade of the morcellator 602. The extension 626 of the outer barrel 622 prevents the entire circumference of the blade 610 from cutting through the tissue simultaneously. This prevents coring and causes the blade 610 to move along the specimen, resulting in the majority of the specimen being removed in one piece. After all of the tissue has been removed or reduced to small pieces sized to fit through the incision, the shield 608 and pouch are removed. The shield 608 advantageously protects and retracts adjacent tissue at the incision and protects the adjacent portion of the containment pouch from accidental contact with the cutting blade 610. The present invention also avoids the creation of secondary openings in the containment pouch to allow insertion of a scope to visualize the morcellation procedure. Secondary openings, which would compromise a closed containment system, are advantageously avoided by the morcellation system 600. Morcellation within a body cavity can result in the release of potentially harmful fragments of the specimen being morcellated. Therefore, morcellation within a closed system is desirable. A closed system is created by placing the specimen within a containment bag and forcing the opening of the bag through the incision to the surface, thereby isolating the specimen within the bag and preventing it from coming into contact with tissue within the body cavity. Traditional solutions for visualization require creating a separate opening in the bag and placing a laparoscope through this opening, thus no longer maintaining a closed system. Alternatively, a scope may be placed through the same incision as the morcellator, resulting in poor visibility and triangulation necessary for optimal observation. The shield 608 advantageously allows cutting mechanisms, including powered morcellators, to be used within a closed system while preventing potential damage to the contained system. The morcellation system 600 can provide visualization of the specimen without a laparoscope by forcing the specimen to the surface when the bag is retracted. The morcellation system 600 maintains and ensures a closed system throughout the morcellation procedure by reducing damage to the tissue containment bag through the use of the shield 608 with a corresponding short morcellator. The length of the shield 608 is approximately equal to the length of the protruding portion of the morcellator 602. The shield 608 surrounds the blade 610, and the shield is positioned between the bag and the morcellator 602.The shield 608 opens and holds the incision opening for easy visualization and removal of the specimen. The shield 608 protects the pouch and tissue at the incision site from damage by the cutting blade 610 or tenaculum 606. The morcellator's outer barrel 622 is surrounded by the shield 608, which prevents accidental contact between the containment pouch and the blade 610, which could result in breaching the closed system. The shield 608 forms a protective cage around the blade, ensuring safe morcellation. In one variation, the length 638 of the shield 608 in its unexpanded configuration is approximately 1 inch (2.54 cm), and the length 640 of the morcellator barrel is also approximately 1 inch (2.54 cm).

[0092] 89 and 90, a morcellation system 600 employing an energy-assisted morcellator 602 is shown. The energy-assisted morcellator system utilizes a tissue bag, tenacious hooks, and a shield 608 in a manner similar to that described above. Rather than rotating the blade 610 to cut tissue, the circular blade 610 remains stationary. The blade 610 and barrel 612 of the morcellator 602 are connected to the output of a monopolar energy system 652 via an energy input 650. The tenacious hooks 606 are connected to a plug 654 that leads to ground on the monopolar energy system 652. Once the target tissue is grasped by the tenacious hooks 606 and brought to the blade 610, monopolar energy is applied to cut the tissue. The extension 626 serves the same purpose as described above. An exhaust port 656 is provided in the housing 616 to prevent inhalation of fumes from the cutting process.

[0093] 91-103, a shield 700 adapted for placement within the vaginal canal is shown. The shield 700 has a shape generally equivalent to the shields described herein. The shield 700 is substantially cylindrical / tubular in shape and is made from a band of material having an inner first end 702 and an outer second end 704 connected to one another 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. While the central lumen 714 is shown as being circular in shape, in other variations it may be oval or an elongated oval or oblong shape. The proximal end 706 includes a radially outwardly extending proximal flange 716 that forms a funnel-shaped entrance to the central lumen 714. The outer surface 634 is concave and gradually flares radially outward toward the distal end 708. At least a portion of the shield 700 overlaps itself when in a relaxed, normal configuration. Curling the shield 700 on itself can reduce its lateral dimension for easier insertion into a vagina or other body orifice or wound incision. The overlapping portions of the shield 700 conform to and fit together. The shield 700 is configured to slide with one end, e.g., the first end 702, against the second end 704. The shield 700 can have a first, reduced lateral or diametric dimension suitable for easy insertion into a vagina or other body orifice. The reduced lateral position is achieved by curling the shield 700 on itself into a tightened, smaller configuration. The shield 700 has a relaxed, normal position with a second lateral or diametric dimension. The second lateral or diametric dimension is larger than the first lateral / diametric dimension. The shield 700 is molded with a bias toward a normal relaxed position, and when the shield 700 is contracted to a first diametric position, it automatically expands or springs open or spreads toward its relaxed and normal position having approximately a second lateral or diametric dimension.The shield 700 can include a lock of the type described herein to secure a lateral or diametric position. The shield 700 further has an expanded configuration with a third lateral or diametric dimension. The third lateral or diametric dimension is larger than the second lateral or diametric dimension. The expanded configuration is achieved by curling the shield 700 in the opposite direction or unfolding the shield 700 to open the central lumen 714. Any of the lateral positions of the shield 700 and any intermediate positions can be locked in place with a lock. The shield 700, and particularly the expanded configuration of the shield 700, serves to retract tissue to open a body opening or wound, thereby providing a safe working channel for the surgical procedure.

[0094] As can be seen in FIGS. 93 and 94 , the first end 702 and the second end 704 each have an S-shaped curve 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 locks configured to secure the lateral dimension of the shield 700. The notches 718 and 720 are shown in an unlocked position in FIGS. 93 and 94 and in a locked position in FIGS. 97 and 98 . The notches 718 and 720 form finger-like extensions configured to interlock with each other to lock the shield 700 in place. In FIGS. 97 and 98 , the finger-like extension located near the notch 718 on the outer second end 704 overlaps with the inner first end 702 to lock the shield 700. As mentioned above, the outer surface 710 of the shield 700 forms a concave surface with an inflection point 722 visible in FIGS. 93 and 94 . The inflection point 722 is located above a mid-plane perpendicular to the longitudinal axis and near the proximal flange 716. The proximal flange 716 serves as a protective surface to protect the containment pouch, retractor 724, and vaginal canal tissue at the insertion site. The shield and / or flange may be made of a hard, rigid, or semi-rigid, plastic, or cut-resistant material. The proximal flange 716, and particularly the inner surface 712 of the proximal flange 716, provides a plate-like surface that a sharp object, such as a scalpel or blade, can advantageously use to cut and reduce the target tissue against this cutting-plate surface for removal and extraction without risk of cutting the containment pouch, adjacent tissue, or retractor.

[0095] 99-103, a shield 700 is shown for use in combination with a retractor 724. The retractor 724 is the same retractor 62 as described with reference to FIGS. 18 and 19. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible sidewall 730. The sidewall 730 defines a central opening extending along the longitudinal axis of the retractor 724. The second ring 728 can be compressed and inserted through the vaginal canal, where it expands to form an anchoring means for the vagina. The first ring 726 is positioned outside the patient's body above the vaginal entrance, where it can be rotated down and retracted to both retract and expand the vaginal canal.

[0096] During a hysterectomy, the uterus is separated from the body by instruments inserted through an abdominal port. After the uterus is separated, the shield 700 can be inserted directly into the vaginal canal. In this configuration, the shield 700 curls onto itself into a contracted configuration, thereby facilitating insertion of the shield 700, and when in place, the shield 700 expands to its normal relaxed configuration while positioned within the vaginal canal, thereby dilating and retracting the vaginal opening. The proximal flange 716 is located near the entrance to the vagina. The separated uterus can be grasped and drawn into the central lumen 714 of the shield 700, and then morselized with a blade against the shield, thereby reducing its size or cutting it into several smaller pieces that can be removed entirely through the vaginal canal.

[0097] In another embodiment, the containment bag is placed into the abdominal cavity through either the abdominal port or the vaginal canal. The extracted uterus is placed into the containment bag. The containment bag's tether is pulled through the vaginal canal. The containment bag's ring is compressed into a low-profile configuration, which facilitates pulling the proximal end of the containment bag through the vaginal canal. The containment bag's ring is pulled outward and expanded to an open configuration, thereby opening the containment bag's mouth. The containment bag's ring is positioned outside the vaginal entrance. The containment bag's ring can be rotated down on itself, causing the bag's side walls to wrap around the ring. This action brings the extracted uterus within the bag near the vaginal opening. Next, the shield 700 is inserted into the mouth of the containment bag and into the vaginal canal. The shield 700 curls downward into a compact configuration, thereby facilitating insertion. The proximal flange 716 is positioned at or near the vaginal entrance. In one embodiment, the proximal flange 716 of the shield 700 snaps under the containment bag's ring. The removed uterus can be grasped with graspers and pulled into the central lumen 714 of the shield 700 where morcellation can begin.

[0098] The distal end of shield 700 is funnel-shaped, with a radial dimension that gradually increases from inflection point 722 toward distal end 708 of shield 700. This funnel-like shape advantageously aids in moving the ablated uterus into shield 700. The uterus is morselized with the blade while it is at least partially located within shield 700, and then completely removed, either whole or in segments. Shield 700 advantageously protects the surrounding vaginal canal and containment pouch from the sharp blade, thereby helping to maintain the integrity of the containment pouch and closed morsel system.

[0099] In another embodiment, the same procedure is performed as described in the previous paragraph, except that after the uterus is placed in the containment bag and the ring of the containment bag is pulled out of 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 then the second ring expands to an open configuration within the containment bag at a location distal to the vaginal canal in the abdominal cavity. The first ring 726 of the retractor 724, now positioned outside the body, is rotated over itself, wrapping 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 out of the way, thereby clearing the vaginal canal for insertion of the shield 700. The containment bag is captured between the retractor and the vaginal canal, holding the containment bag in place and preventing its entry into or exit from the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724, which is positioned within the containment bag. The shield 700 can be curled downward, if necessary, into a compact configuration, after which the shield expands to self-anchor the shield 700 in place. The shield 700 is then coupled 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 FIGS. 99-103. The uterus can then be grasped with surgical instruments and pulled out of the containment bag pouch and into the central lumen 714 of the shield 700, where it is morselized with a blade while at least partially located within the shield 700, and then completely removed, either whole or in sections. The shield 700 advantageously protects the surrounding vaginal canal as well as the containment bag from the sharp blade, thereby providing the surgeon with a mechanism to perform morsel safely and quickly, while helping to maintain the integrity of the containment bag and closed morsel system.

[0100] In another variation, the same procedure is performed in the same manner as described in the preceding paragraph, except that the retractor 724 is placed in the vaginal canal and then the containment bag containing the specimen is pulled through the vaginal canal. In this configuration, the removed uterus is placed in a containment bag placed in the abdominal cavity, and a tether attached to the proximal end of the containment bag is pulled through the central lumen of the retractor with a grasper, bringing the ring and mouth of the containment bag outside the patient's body. The ring of the containment bag can then be lowered while rotating on itself, bringing the detached uterus closer to the opening. The flexible retractor 724 is then curled onto itself into a compact configuration, and the shield 700 is then released, reducing its size laterally, causing the shield to expand due to its bias, which causes the shield to expand laterally from its compact configuration. As the shield 700 expands, it self-settles and retracts the containment bag, thereby creating a working channel in the central lumen 714 of the shield 700 for removal and morcellation of the dissected uterus. The proximal flange 716 of the shield 700 can be snapped onto the ring of the containment bag or under the first ring 726 of the retractor 724. The containment bag is captured between the retractor 724 and the shield 700, preventing it from sliding proximally or distally during the procedure. The flange 716 can serve as an upper surface of a cutting plate against which a sharp blade can be cut for central removal. For all of the above hysterectomy procedures, the containment bag and retractor combination of FIG. 20 can be used in place of one or more of the containment bag and retractor 724.

[0101] In yet another embodiment, the shield 700 is used with a retractor 724, as shown in FIGS. 99-103. In this embodiment, the retractor 724 is placed within the vaginal canal. The uterus is ablated using standard techniques either before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed to allow for easy insertion into the vaginal canal, and then the second ring expands to an open configuration within the abdominal cavity at a location distal to the vaginal canal. The first ring 726 of the retractor 724, located outside the body, is rotated over itself, wrapping the side wall 720 of the retractor 724 around the first ring 726. This action retracts the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724. The shield 700 can be curled downward, if necessary, to a compact configuration, after which the shield 700 can expand to self-secure the shield 700 in place. Shield 700 is then coupled to the first ring 726 of retractor 724 by snapping the proximal flange 716 of shield 700 under the first ring 726, as shown in Figures 99-103. The uterus can then be grasped with surgical instruments and drawn into the central lumen 714 of shield 700, where it is morselized with a blade while at least partially located within shield 700, and then completely removed, either whole or in sections. Shield 700 advantageously protects the surrounding vaginal canal as well as retractor 724 from the sharp blade, while providing the surgeon with a mechanism for performing morsel safely and quickly.

[0102] 104-107, another form of shield 800 for use within the vaginal canal is shown. The shield 800 has a top end 802 and a bottom end 804 connected to each other by a sidewall 806. The shield 800 has an opening 808 extending through the top end 802 and the bottom end 804. The shield 800 further has a first flange 810 and a second flange 812. The first flange 810 extends distally from the bottom end 804. The first flange 810 is curved to form an elongated surface that is concave toward the longitudinal axis 816. The first flange 810 may also be a substantially flat elongated surface. The first flange 810 has a distal end 814 that is angled away from the longitudinal axis 816. The second flange 812 extends distally from the bottom end 804. The second flange 812 has a hook 818 configured to attach to a ring on a containment bag or the proximal ring of a retractor by snapping under the ring. Figures 106 and 107 show the shield 800 coupled to a retractor 724. The retractor 724 is the same retractor described above with reference to Figures 18 and 19 and 99-103. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible sidewall 730. The sidewall 730 defines a central opening extending along the longitudinal axis of the retractor 724. The second ring 728 can be compressed and inserted through the vaginal canal, where it expands to provide anchoring for the canal. The first ring 726 is positioned above the vaginal entrance outside the patient's body, where it can be rotated down and retracted to expand the vaginal canal.

[0103] In use, the shield 800 will now be described during a surgical procedure, such as a hysterectomy, although the present invention is not limited to use in hysterectomies and may be utilized in any targeted tissue removal or morcellation procedure, in which the uterus is separated from the body by instruments inserted through an abdominal port.

[0104] In one configuration, the shield 800 is used with the retractor 724 shown in FIGS. 106 and 107. In this configuration, the retractor 724 is placed into the vaginal canal. The uterus is ablated using standard techniques either before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed to allow easy insertion into the vaginal canal, and then the second ring expands to an open configuration within the abdominal cavity at a location distal to the vaginal canal. The first ring 726 of the retractor 724 is located outside the body, and the ring is rotated on 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 coupled 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 inside the first ring 726, as shown in FIGS. 106 and 107. Additional hooks can be provided to couple the shield 800 to the retractor 724. The shield 800 covers or fits over 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. The uterus can then be grasped with surgical instruments, pulled proximally, and positioned over or juxtaposed against the first flange 810. The first flange 810 of the shield 800 is curved, and advantageously provides support to cradle the dissected uterus, preventing it from slipping off the first flange 810 while the surgeon reduces the size of the uterus so that a blade can be used to cut it and remove it through the vaginal canal. The first flange 810 advantageously serves as an upper surface of a cutting plate, allowing a blade to safely cut tissue near or in contact with the first flange 810 against the upper surface of the cutting plate. The angled distal end 814 of the first flange 810 provides an additional vaginal dilator and a ramp or ramp to move and guide the uterus proximally into the vaginal canal and toward the vaginal opening.At the proximal end of the shield 800, a ring-shaped portion of the shield 800 advantageously safely retracts the lips out of the way of the morcellation blade. While the uterus is at least partially located within the shield 800, it is morcellated with the blade and then completely removed, either whole or in segments. The shield 800 advantageously protects the surrounding vaginal canal, lips, and retractor 724 from the sharp blade, while providing the surgeon with a mechanism to perform morcellation safely and quickly.

[0105] In another embodiment, the containment bag is placed into the abdominal cavity through either the abdominal port or the vaginal canal. The removed uterus is placed into the containment bag. The containment bag's tether is threaded through the vaginal canal and pulled. The containment bag's ring is compressed to a low-profile configuration, thereby facilitating pulling the proximal end of the containment bag through the vaginal canal. The containment bag's ring is pulled outward and expanded to an open configuration, thereby opening the mouth of the containment bag. The containment bag's ring is positioned outside the vaginal entrance. The containment bag's ring can be rotated down and over itself, wrapping the side walls of the bag around the ring. This action brings the removed uterus within the bag near 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 within the containment bag is grasped with a grasper and pulled over the first flange 810 of the shield 800. The beveled distal end 814 of the first flange 810 helps guide the uterus at an angle into position and supports it to be cradled for morcellation. With the uterus at least partially positioned adjacent the first flange 810, the uterus is morcellated with the blade and then completely removed, either whole or in sections. 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 closed morcellation system.

[0106] In another embodiment, the same procedure is performed as described in the preceding paragraph, except that after the uterus is placed within the containment bag and the rings of the containment bag are retracted outside 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 then the second ring expands to an open configuration within the containment bag at a location distal to the vaginal canal in the abdominal cavity. The first ring 726 of the retractor 724 is rotated over itself, wrapping 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 out of the way, thereby clearing the vaginal canal for insertion of the shield 800. This traps the containment bag between the retractor 724 and the vaginal canal, holding it in place and preventing its entry into or exit from the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724, which is positioned within the containment bag. The shield 800 is coupled 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 pouch of the containment bag into apposition with the first flange 810 of the shield 800, whereupon the uterus is morselized with a blade while in at least partial contact with the first flange 810, and then completely removed, either whole or in segments. The shield 800 advantageously protects the surrounding vaginal canal and the containment bag and retractor 724 from the sharp blade, thereby helping to maintain the integrity of the containment bag and closed morsel system while providing the surgeon with a mechanism for safely and quickly performing morsel. For all of the hysterectomy procedures described above, the containment bag and retractor combination of FIG. 20 can be used in place of one or more of the containment bag and retractor 724. It will also be appreciated that the present invention is not limited to hysterectomy procedures, but may be utilized to morsel, separate, and remove any tissue or organ.

[0107] 108 and 109, a modified shield 900 is shown having a funnel 902 with retraction fingers 904 at its distal end. The funnel 902 defines a central opening 906. The proximal end of the shield 900 forms a proximal flange surface that circumferentially surrounds the central opening 906, forming a funnel-shaped entrance to the central opening. The shield 900 is inserted into a body opening or wound incision by first inserting the retraction fingers 904 and then inserting or tilting the central portion of the funnel 902 into the opening. The proximal end of the funnel 902 rests on top of the abdominal or other external surface of the body. The proximal flange provides a location for a cutting plate to morsel tissue. The retraction fingers 904 help retract the incision or body opening and help keep the shield 900 anchored in place. The retraction fingers 904 form a distal flange that extends only partially around the circumference of the distal end of the central opening 906. The retraction fingers 904 are curved so that the side profile of the shield 900 where the retraction fingers 904 are located is substantially C-shaped, with the top of the letter "C" extending a greater distance laterally than the bottom of the "C." The funnel 902, when used in conjunction with the shield 900, also provides protection for surrounding tissue as well as the containment bag and retractor. For example, the containment bag is inserted through a body opening or incision, and after the specimen is inserted into the bag, the mouth of the containment bag is pulled back through the incision. The proximal end of the containment bag is placed on the abdomen, and the shield 900 is inserted into the mouth of the containment bag and secured by the retraction fingers 904. A grasper is inserted into the central opening 906, and the specimen within the containment bag is pulled toward the central opening 906. The blade is then used to divide the specimen so that it can be removed whole or in pieces through a small incision / orifice. The shield 900 is made of a strong, rigid plastic that is thick enough to prevent and reduce the possibility of penetration by the blade, yet protect adjacent tissue and maintain the integrity of the containment bag.

[0108] In another configuration, the shield 900 is used with the same retractor described above. The retractor is placed in the incision either before or after the bag is placed, and then the shield 900 is inserted into the opening of the containment bag and the retractor. In one configuration, the proximal end of the shield 900 is sized and shaped to fit over or snap onto the proximal ring of the containment bag or retractor. One configuration of the shield 900 adapted to fit over the proximal ring of the retractor or containment bag is shown in FIGS. 109B and 109C with an oval central lumen 906 and a circular central lumen 906, respectively. The shield 900 in FIGS. 109B and 109C has at least one hook 905 configured for attachment to the ring of the retractor or containment bag.

[0109] Referring now specifically to FIG. 109 , the funnel 902 has a circumferential rim 908 raised from its inner surface. The rim 908 is configured to couple to a blade, which will be described in more 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 FIG. 110 . The second shield 912 is generally similar to the shields described with reference to FIGS. 71-86 and other shields described herein. In one form, the second shield 912 is spiral in shape and is vertically collapsible and expandable as described above. In the form shown in FIG. 110 , the second shield 912 is not spiral, but is substantially cylindrical with a concave outer surface and a gap 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 can have a tab or finger pull to aid in its removal from the body opening / incision. The second shield 912 has a contracted configuration in which the lateral dimension is smaller than the normal relaxed configuration shown in FIG. 110. The contracted configuration is optimal for insertion into a wound or body opening 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 resist penetration by blades or other sharp objects or instruments under normal use to protect adjacent tissue.

[0110] Referring now to FIG. 111 , a first shield 900 is shown coupled to a second shield 912. The C-shaped second shield 912 is positioned within the first shield 900 such that a proximal flange 916 of the second shield 912 rests over at least a portion of the inner surface of the funnel 902 of the first shield 900. A raised portion 910 of the shield 900 is received within a gap 914 of the second shield 912. The coupling 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 its lower periphery where the retraction fingers 904 are located, 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. The distal flange 918 also provides a funnel-shaped entrance into the central lumen 922 of the second shield 912, which aids in moving tissue into and out of the body through the shield 900, 912 while providing protection for surrounding tissue, the containment bag, and retractors, if used. The shields 900, 912 may be used with a manual bladed morcellator or with a short powered morcellator similar to that described above with reference to Figures 87-90.

[0111] 112 and 113, a blade carrier 926 is shown coupled to a first shield 900, which in turn is coupled to a second shield 912 to form another form of 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-like shape and has circumferential hooks configured to fit over, snap onto, and couple to the first shield 900. Specifically, as shown in FIG. 113, the circumferential hooks of the funnel 928 mate directly with the raised circumferential rim 908. In one form, the blade carrier 926 is snap-fit ​​with the first shield 900 so that it is held vertically but can rotate relative to the first shield 900. The blade receiver 932 receives the blade 934 in a blade channel 936. The blade 934 is connected to a 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 FIGS. 114 and 115. In one form, 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 at its proximal end relative to the blade handle 938 to effect back and forth movement of the blade 934 at its distal end. The reciprocating motion can also be provided by an electric motor (not shown) located within the blade handle 938 at its proximal end in a removable and reusable handle attachment. The blade receiver 932 can be provided in two parts: a first part and a second part. The first portion has a blade channel 936 with a slot 944 configured to receive a pin 940 and to guide the translation of the blade 934 within the blade channel 936 .One end of a pin 940 is coupled to the blade 934, and the other end of the pin 940 is coupled to the distal end of an inner rod 942, which is housed within a second portion of the blade receiver 932, which together house the blade 934. The blade receiver 932 is coupled to a funnel 928 of the 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 in the exposed state, the blade carrier 926 can be rotated relative to the first shield 900, thereby cutting tissue 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 it is at least partially hidden within the blade receiver 932. When in the retracted position, the sharp sides of the blade 934 are substantially hidden, thereby making the blade carrier 926 safe to handle. The blade 934 can be moved manually or automatically from the retracted position to the exposed position to cut tissue. This reciprocating cutting action can be selectively performed manually by a user or automatically if tissue cutting is desired or performed in a continuous reciprocating manner. Additionally, the reciprocating cutting action can be performed simultaneously by rotation of the blade carrier 926 relative to the first shield 900 or intermittently by 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, 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 exposure of the blade 934 can be selected by the user to thereby perform selective cutting. For example, the blade 934 can be partially exposed from the fully retracted 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 in the blade carrier 926, but not beyond the distal end of the second shield 912, so that the blade 934 and blade path are always surrounded and enclosed by either one or more of the first shield 900, the second shield 912, and the blade carrier 926. In another form, the distal end of the blade 934 may extend slightly beyond the distal end of the second shield 912.

[0112] In one configuration, the blade 934 is fixed relative to the blade receiver 932, and the blade does not reciprocate relative to the blade carrier 926, but only rotates relative to the first shield 900. In another configuration, the blade carrier 926 is fixed relative 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 rotary cutting action has the purpose of increasing the chances of removing the specimen as a single excision rather than multiple small pieces, while ensuring protection to the surrounding tissue. Also, the blade 934 is shown as curving downward into the central opening. In another configuration, the blade 934 extends radially inward in a plane perpendicular to the central lumen, and the blade has a configuration similar to a guillotine or cigar cutter. It is within the scope of the present invention for blades 934 to have an approach angle of 0° to less than 180°, where an approach angle of zero means that blades 934 intersect a plane perpendicular to the central lumen longitudinal axis that is parallel to the longitudinal axis at the 12 o'clock position. An approach angle of less than 180° means that blades 934 intersect a plane perpendicular to the longitudinal axis when viewed from below that plane at approximately the 5 o'clock and 7 o'clock positions.

[0113] 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.

[0114] 117-119, a shield assembly 950 is shown including a blade carrier 926, a first shield 900, and a second shield 912. A 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 visible in FIGS. 109, 111, 117, and 118. The notch 948 facilitates separation and removal of the blade carrier 926 from the first shield 900 by providing a location for a finger to snap the blade carrier 926 off the first shield 900.

[0115] Referring now to Figures 120-126, another form of 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 includes a blade receiver in two pieces 932a and 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 drawn to scale and is depicted for illustrative purposes to include a variation in which a reusable handle extension 946 can be attached to the proximal end of the blade handle 938 in a disposable configuration. The variation of Figures 120-126 is substantially identical to the form shown in Figures 109-119, with some modifications. The second shield 912 is not a cutting barrel, but rather is spiral-wound in nature as described above. The second shield 912 is shown in Figure 120 as a compressed pair. The first shield 900 has an outer rim 908 located around the top periphery of the first shield 900. The funnel 928 of the blade carrier 926 snaps under the outer rim 908 in the configuration shown in Figures 120-126.

[0116] In another form of the shield, the shield is formed around a helical surface whose cross section perpendicular to the helical guide path is a parabola. Once released, the helical surface compresses itself into the shape of a catenary within which the shield lies during its rest state. The following parametric equations cover the shield variations:

[0117] x(u,v)=β[cos(α)sinh(v)sin(u)+sin(α)cosh(v)cos(u)](1)

[0118] y(u,v)=γ[-cos(α)sinh(v)cos(u)+sin(α)cosh(v)sin(u)](2)

[0119] z(u,v)=δ[ucos(α)+vsin(α)](3)

[0120] The value α is a constant, fixed parameter that changes the progression of the transformation 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. Shield variants have values ​​of α greater than 0 and less than π / 2, which are considered to lie on the open interval (0,π / 2). Other shield variants have values ​​of α greater than 0 and less than or equal to π / 2, which are considered to lie on the open interval (0,π / 2). Other shield variants have values ​​of α 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, and δ are also constants. If β,γ,δ∈R\{0}, then for β<0, γ<0, δ<0, the rotation flows counterclockwise. For any β,γ,δ>0, the rotation flows clockwise. The parametric equations create a surface on the u-v plane. The values ​​of vectors u and v can be considered when u∈(-π,+π) and v∈(-∞,+∞).

[0121] Referring now to FIG. 127 , another embodiment of a containment bag 1000 of the present invention is shown. The bag 1000 has a sidewall 1002 defining an opening 1004 at a proximal end. The bag 1000 has a longitudinal axis substantially perpendicular to the opening 1004. The sidewall 1002 can form any shape for the bag 1000, such as a cylindrical, elongated, spherical, etc., and the sidewall may or may not have a base or bottom panel from which the sidewall 1002 extends toward the proximal end. The sidewall 1002 can extend downward to form a seamed or seamless base. For example, the bag 1000 can be formed from a flat length of material that is folded and joined along the sides, such that a seam is not formed along the base, but rather is located at the side of the bag 1000 and extends upward substantially perpendicular to the longitudinal axis.

[0122] Still referring to FIG. 127 , the containment bag 1000 has at least a first ring 1006 disposed 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 FIG. 127 . The second ring 1008 is disposed a distance below the first ring 1006 and connected to the bag 1000. The first ring 1006 and the second ring 1008 are resilient and compressible from an expanded configuration that is round or oval in shape to a collapsed, elongated configuration with reduced lateral dimensions suitable for entry into a small incision, a body opening, or through the lumen of a trocar. In one variation, the second ring 1008 is not used. The bag 1000 is collapsible to a short length along the longitudinal axis of the bag 1000. Next, if the second ring 1008 is used, the first ring 1006 and the second ring 1008 are collapsed into their collapsed, elongated configuration, which then easily compresses the lateral dimension to deploy the containment bag 1000 within the abdominal cavity. Once within the abdominal cavity, the compressed rings 1006, 1008 return to their original expanded, open configuration. With the rings 1006, 1008 in their expanded configuration within the abdominal cavity, the bag 1000 is easily oriented within the abdominal cavity. Locations within the perimeter of the rings 1006, 1008 are targeted for placement of the excised tissue or organ. In one variation, the bag 1000 in its collapsed configuration is not right-side up, as either side can be used to place the specimen within the interface of the first / second rings 1006, 1008. The first ring 1006 serves as a circumferential guide for placement of the specimen within the periphery of the first ring 1006, and therefore may be brightly colored or colored in contrast to the rest of the bag 1000 or its intended enclosure, so that the first ring can be easily viewed laparoscopically. After the excised tissue or organ is placed within the periphery of the first ring 1006, the first ring 1006 is moved toward the exit incision or body orifice. Lifting the ring 1006 results in the tissue being excised falling or deeper into the interior space 1010 of the bag.As the bag is moved toward the exit opening, the tissue specimen becomes trapped within the interior space 1010 of the bag 1000. The first ring 1006 is compressed into a reduced, elongated configuration and pulled through the exit orifice, opening, or incision. Once through the opening, the first ring 1006 self-expands and springs back to an open, expanded configuration that resides outside the patient's body above or near the abdominal wall and covers the exit orifice, opening, or incision. The first ring 1006 is turned or flipped over on itself by inverting it outward or inward, wrapping the bag 1000 around the first ring 1006. Turning the first ring 1006 over on itself in the opposite direction allows the bag 1000 to unfold from the first ring 1006. In one variation, the first ring 1006 has a cross-section whose length is greater than its width. The elongated cross-section of the first ring 1006 advantageously keeps the bag's side wall 1002 wrapped around the first ring 1006. If the first ring 1006 had a circular cross-section, the first ring 1006 could easily rotate on and off itself, thereby winding the side wall 1002 onto or unwinding the first ring 1006. By rotating the first ring 1006 on itself, the bag 1000 is pulled upward, bringing the specimen within the bag 1000 closer to the opening. Rotating the first ring 1006 on itself reduces the distance of the side wall 1002 between the first ring 1006 and the second ring 1008, thereby forcing the second ring 1008 closer to the first ring 1006, thereby securing the abdominal wall between the first ring 1006 and the second ring 1008, thereby securing the bag 1000 to the patient for morcellation. The rolling action of bag 1000 reduces the volume of bag 1000 to form a well-formed, taut protective apron at the opening as well as outside the patient's body surrounding the opening. The rolling action can also serve to retract tissue at the opening, thereby advantageously enlarging the opening for easy tissue removal from within bag 1000.The specimen is then withdrawn from the bag 1000 by morcellating it manually with a blade or automatically with an electronic morcellator into a size and shape that will allow it to pass through the opening and be removed from the bag 1000. After the tissue specimen is removed from the bag 1000, the first ring 1006 is rotated back on itself, widening the space between the two rings 1006, 1008 if necessary. The second ring 1008 is then compressed to its reduced, elongated configuration and withdrawn through the opening and out of the patient's body, and the bag 1000 is removed from the patient.

[0123] The bag 1000 and / or the sidewalls 1002 of the bag 1000 are made of a material that is highly cut-resistant to sharp objects, such as scalpel blades and blades used in electronic morcellators. In one form, 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 form, the bag 1000 is made of Dyneema® coated with an elastomer to prevent fluid from penetrating the plane of the material. In one form, the entire bag 1000 is made of a cut-resistant material. In another form, only selected portions of the bag 1000 are made of a cut-resistant material. In one form, at least a portion of the sidewalls 1002 of the bag 1000 located between the first ring 1006 and the second ring 1008 is made of a 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 anticipated. In another embodiment, a lower portion of the distance between the two rings 1006, 1008 is made of a cut-resistant material, and an upper portion of the distance between the two rings 1006, 1008 is utilized for wrapping around the first ring 1006. In 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 fabric thickness that is less than the thickness of the sidewalls or the fabric thickness of the lower portion. In an embodiment where only a portion of the bag 1000 is made of a cut-resistant material, the remaining portion is made of a suitable polymeric material as described above. In one embodiment, using a bag 1000 made of a cut-resistant material eliminates the need for the retractor described above to be used in conjunction with the bag 1000 during the morcellation procedure. Therefore, bag 1000 advantageously provides cut resistance and safety shielding during morcellation, as well as helps to retract the opening through which it is inserted. Because bag 1000 is cut resistant, bag 1000 can be used without a shield / guard of the type described above. The lack of a shield or guard advantageously provides a larger working space.

[0124] Embodiments of the bag 1000 are comprised of sheets, membranes, fibers, and / or strands of one or more materials that provide the sheath with cut resistance as well as abrasion and puncture resistance. Suitable sheets, membranes, fibers, and / or strands are comprised 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, silk, etc. Semi-synthetic fibers include nitrocellulose, cellulose acetate, rayon, etc. 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®), and the like, as well as blends, copolymers, composites, and mixtures thereof. Suitable metals include stainless steel, spring steel, nitinol, superelastic materials, amorphous metal alloys, and the like. Bag 1000 has a retractor assembly that provides both specimen containment and tissue retraction features. Additional retraction features and materials and configurations that may be incorporated into bag 1000 in accordance with aspects of the present invention are described in U.S. Patent Application Publication No. 2011 / 00542610 A1, which is incorporated by reference and incorporated herein in its entirety.

[0125] Currently available morcellators generally cut tissue with an exposed, unprotected instrument, such as a sharp blade or energy tip, within the body cavity. This poses additional risks for most morcellators, as the exposed blade / tip can easily contact unintended areas, potentially damaging organs, tissue, blood vessels, etc. Because current morcellators cut tissue in open areas, small pieces of severed tissue can be left behind after the tissue removal procedure. These pieces can cause endometriosis in women, a condition in which uterine cells attach themselves to other organs or tissue walls. These pieces can also contain cancer cells that must be removed in their entirety. Currently, if the 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 of the pieces are found, the extra step of examining the body cavity for small pieces of tissue still increases surgical time. Furthermore, current morcellators require two people to perform the procedure. One person must pull the tissue through the tenacious morcellator, while the other must hold the remaining tissue mass from inside the body cavity close to the tip of the rotating blade. When this procedure is performed, the specimen typically falls or tears away from the instruments holding it in place during morcellation. This adds time because the person responsible for positioning the specimen in front of the morcellator must find the tissue, re-clamp the instruments to it, and then place the specimen again in front of the morcellator. Therefore, while morcellation within a containment means, such as a bag, is desirable, the bag itself presents a potential for puncture and spillage of contents. The specimen bag of one form of the present invention has a protective inner layer of material that resists puncture caused by the tenacious jaws and rotating morcellator blade. Additionally, because the morcellator is locked in a stationary position using any of the stabilizers described above, the risk of the blade contacting the bag is greatly reduced. The specimen bag contains the entire tissue sample, so that if small pieces fall out of the larger specimen during morselization, these small pieces will be removed when the bag is withdrawn from the patient.This increases patient safety and reduces surgical time for the morcellation procedure because there is no need to search for tissue particles left behind. The specimen bag supports the tissue and keeps it in place. This allows one person to perform the morcellation procedure instead of two. It also reduces the time required to continuously reposition and reclamp the specimen.

[0126] 128-134, tissue morcellator 3000 is a multi-component medical instrument used to capture tissue specimens, such as uterus, within the human body under laparoscopic surgical conditions and reduce the size of such tissue specimens for removal through a small incision, body orifice, or opening, which may or may not include a laparoscopic port. Morcellator 3000 has a gear housing 3016 containing a gear train, as can be seen clearly in FIG. 133, which is connected to a flexible transmission shaft 3018 that is connected at its proximal end to a motor for rotating the morcellator blade 3010. Morcellator 3000 has a central working channel lumen 3020 extending through the length of morcellator 3000. The inner and outer tubes of morcellator 3000 are stationary and do not rotate relative to the moving blade 3010 so as not to present a moving surface against the tissue as it is being removed through lumen 3020. In one form, the morcellator 3000 includes a camera 3022. The camera 3022 may be integrally formed with the rest of the morcellator 3000 or may include a separate add-on that slides along the morcellator shaft and is coupled to the morcellator 3000 as shown in FIG. 134. Also, as shown in FIG. 132, the distal end of the morcellator shaft has a fixed protruding appendage that covers at least a portion of the distally extending blade to interrupt the morcellation of the tissue to prevent the tissue from rotating relative to the instrument.

[0127] Still referring to FIGS. 128-134 , the morcellation system further includes a tenacious hook 3012 having an elongated shaft 3028 and a jaw-like grasper at its distal end controlled by a handle 3024 at its proximal end for opening and closing the jaws 3026 to grasp tissue. The shaft 3028 and jaws are configured to fit within the working channel 3020 of the morcellator 3000 and extend and protrude from the distal end of the morcellator shaft. The tenacious 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 optimize an upward pulling motion. The handle 3024 has a lever 3030 that can be pulled toward the handle 3024 to close the jaws 3026, as shown in FIG. 129 . Alternatively, the lever 3030 can be pulled to open the jaws 3026. The lever 3030 is under spring tension so that it springs open and away from the handle 3024, which can define a closed configuration of the jaws 3026, allowing the user to focus on pulling the tenon 3012 upward to remove tissue. Alternatively, the trigger is under spring tension so that the lever 3030 springs open and away from the handle 3024, opening the jaws 3026.

[0128] With particular reference to FIGS. 130-132 , the tenacious jaw 3026 has a curved distal tip 3032. The jaw 3026 includes an upper jaw and a lower jaw hinged to one another. The upper and lower jaws each have a rounded, curved distal end that is devoid of any sharp edges along the curve traced by the distal end 3032 as the jaws 3026 open and close. In the closed configuration shown in FIGS. 130 and 131 , the curved distal tip 3032 does not have any exposed sharp points or edges that could pose a risk to the integrity of the tissue or pouch when in the open or closed configuration. The interior of the upper and lower jaws includes teeth 3034. The distal tip 3032 also includes upper and lower interlocking teeth 3034 that provide a smooth, curved outer surface to provide a positive grip on the grasped tissue while protecting any surrounding tissue and / or pouch. 132 shows the jaws 3026 in an open configuration, next showing the pathway 3036 during opening and closing of the tenaculum, and then showing the distal end 3032. The curved distal end 3032 advantageously protects the pouch being morcellated from puncture as the tissue is grasped. Even when the jaws 3026 are fully open, the curved distal end 3032 of the jaws can protect the pouch from unwanted puncture.

[0129] Referring now to FIGS. 135A-135D and 136A-137B, a morcellation system includes a specimen collection container bag 3002. The described morcellation system may be adapted for use with a powered morcellator, as described above, or may be used in manual morcellation methods. The bag 3002 is shown in a flattened position in FIG. 135A and in a rolled-up position in FIGS. 135B-135C. The bag 3002 has a bag ring 3004 surrounding the opening or mouth of the bag 3002. FIG. 136A shows a tissue sample 3006 captured within the bag 3002 with the bag ring 3004 pulled outward. FIG. 136B shows the bag ring 3004 pulled completely through the body orifice to expose the interior of the bag 3002 to the outside of the body for removal of the sample 3006 within the bag 3002. In FIG. 136B, the tissue guard 200 is shown ready for insertion into the body orifice. Although tissue guard 200 is depicted, any tissue guard of the present invention may be employed.

[0130] 137A-137C and 138A-138C, another configuration of a bag 3002 is shown. The bag 3002 has a bag ring 3004 with an elongated cross-section, such as the cross-section shown in FIG. 137C. The bag 3002 in FIGS. 137A-137C is configured so that the side walls of the bag 3002 can be rolled down onto the bag ring 3004. FIG. 138A shows the bag 3002 with a tissue 3006 specimen located therein. The bag ring 3004 has been pulled through a body opening to the surface of the body. FIG. 138B shows the bag ring 3004 pulled all the way to the surface, and FIG. 138C shows the bag ring 3004 turned or inverted on itself to reduce the length of the bag's side walls and bring the contents of the bag to a surface where they can be easily morselized, as indicated by the arrows in FIG. 138C and described herein above. The bag ring 3004 is not limited to the cross-section of FIG. 137C ; any cross-section that allows the bag to be wrapped around the bag ring is within the scope of the present invention. The bag ring 3004 is flexible so that it can be crushed and compressed into an elongated shape, allowing the bag ring to be inserted and removed through a small incision or body orifice. The elastic bag ring 3004 expands upon release to its open-mouth configuration, allowing for easy placement of the specimen 3006 within the interior of the bag 3002. The bag 3002 has an open top, and the semi-rigid bag ring 3004 is attached to the open top at or near the mouth of the bag 3002. The bag 3002 can be deployed within the body, for example, in the abdomen, with a trocar or other deployment instrument. The bag 3002 can be manipulated with a grasper. The specimen 3006 is placed within the bag 3002, and the bag 3002 is then retrieved through a body wall 3056, for example, the abdominal wall. The entire pouch 3002 will not pass through the small laparoscopic incision due to the large size of the specimen 3006. The semi-rigid pouch ring 3004 is the only portion that reaches the surface while the remainder of the pouch remains within the abdominal cavity of the body. The cross section of the semi-rigid ring allows for the pouch 3002 to be shortened by a rolling process. This not only shortens the pouch 3002 but also aids in wound retraction.The tissue 3006 sample acts as an anchor to allow retraction of the wound opening, thereby enabling a powered or manual morcellation instrument to achieve increased approximation of the tissue 3006. Once the bag 3002 is in place, morcellation can begin. As the tissue sample 3006 decreases in size, the semi-rigid bag ring 3004 is rotated further on itself to bring the tissue 3006 closer to the surface and allow easier access for morcellation. Once a sufficient amount of tissue 3006 has been removed, the bag 3002 can then be removed from the patient. FIG. 138C shows the tissue guard 200 ready for insertion into a body opening and into the bag 3002.

[0131] Referring to FIGS. 139A-139C, the bag 3002 is connected to a delivery shaft 3038 configured to open and close the mouth of the bag 3002. When in the open-mouth configuration, the delivery shaft 3038 is used to conveniently scoop the specimen 3006. After capturing the specimen 3006 and directing the bag ring 3004 through the body opening to the surface for morselization and removal of the specimen 3006, the delivery shaft 3038 is operated to close the mouth of the bag 3002. The bag 3002 has an open top, to which a semi-rigid bag ring 3004 is attached. The bag 3002 is attached to a bifurcated (two-pronged) shaft 3038. The forks are made of a semi-rigid material, such as spring steel. The purpose of the delivery shaft 3038 is to allow the bag to be manipulated with precision and great ease. The system is deployable into the abdomen via a trocar cannula 3044. The specimen 3006 is placed into the sack 3002, which is then retrieved through the abdominal wall 3056. To retrieve the sack 3002, the bifurcated shaft 3038 is pulled through the trocar cannula 3044 until a corner of the sack 3002 is inserted into the distal tip of the trocar cannula 3044. Once the sack 3002 is engaged with the trocar cannula 3044, the sack 3002 can be pulled up through the wound opening to the surface. The entire sack 3002 does not pass through. The semi-rigid sack ring 3004 is the only portion that can reach the surface. Once at the surface, the bifurcated delivery shaft 3038 can be removed from the semi-rigid sack ring 3004. The cross section of the semi-rigid sack ring 3004 allows for shortening of the sack 3002 by a rolling technique. This not only shortens the sack 3002, but also aids in wound retraction. The tissue 3006 sample acts as an anchor to allow retraction of the wound opening, thereby allowing a powered or manual morcellation instrument to achieve increased approximation of the tissue 3006. Once the bag 3002 is in place, morcellation can begin. As the tissue 3006 sample is reduced in size, the semi-rigid bag ring 3004 is rotated further on itself to bring the tissue 3006 closer to the surface and allow easier access for morcellation.Once a sufficient amount of tissue 3006 has been removed, the bladder 3002 can then be removed from the patient. In another configuration, the bladder 3002 includes a second bladder ring 3040. The second bladder ring 3040 is attached to the bladder 3002 approximately midway below the bladder 3002. This second bladder ring 3040 serves as an anchor that can shorten the bladder 3002 while simultaneously retracting the wound to its fullest potential opening. The bladder 3002 is attached to a bifurcated (two-pronged) delivery shaft 3038. The forks are semi-rigid. With the first bladder ring 3004 positioned outside the patient's body, the first bladder ring 3004 is turned / flipped over on itself. The cross-section of the semi-rigid first bladder ring 3004 allows for the bladder 3002 to be shortened by a rolling method. This not only shortens the bladder 3002 but also aids in wound retraction. A second bladder ring 3040 located midway down the sack 3002 acts as an anchor to allow maximum retraction of the wound opening, thereby allowing greater access to the tissue 3006 with various morcellation instruments. Once the sack 3002 is in place, morcellation can begin. Once a sufficient portion of the tissue 3006 has been removed, the sack 3002 can be removed from the patient.

[0132] 140A and 140B and 141A-141D, another embodiment of a bladder 3002 of the present invention is shown. The bladder 3002 has a sidewall defining an interior and a mouth. A first bladder ring 3004 and a second bladder ring 3040 are provided. The second bladder ring 3040 is spaced distally from the first bladder ring 3004 and connected to each other by the sidewall. The bladder 3002 has a balloon 3042 provided at the bottom of the bladder 3002. The balloon 3042 forms at least a portion of the base of the bladder, and the 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 within the balloon 3042. The inflation pressure source can also provide negative pressure to draw inflation fluid to deflate the balloon 3042, if desired by a user. The inflation pressure source is activated manually or automatically by a user. The balloon 3042 at the base of the bladder 3002 is spaced distally from the second bladder ring 3040, as shown in FIG. 140A. FIG. 141A shows the bladder 3002 inserted into the body through the body wall 3056, with the first bladder ring 3004 pulled outward to provide access to the interior of the bladder 3002 so that the specimen 3006 contained therein can be removed from the bladder 3002. FIG. 141B shows the proximal end and mouth of the bladder 3002 being pulled until the second bladder ring 3040 substantially engages the underside of the body wall 3056. FIG. 141C shows the first bladder ring 3004 being turned on itself to wrap the side walls of the bladder 3002 around the first bladder ring 3004. As the first bladder ring 3004 is rotated on itself, the length of the sidewall located between the first bladder ring 3004 and the second bladder ring 3040 decreases. This decrease in sidewall length brings the base of the bladder 3002 and the specimen contained within the bladder 3002 closer to the surface opening of the body. Figure 141D shows the balloon 3042 in an inflated state, which further lifts the specimen 3006 closer to the opening for easier visualization, dissection, and removal.The balloon 3042 advantageously provides an additional protective interface or barrier between the interior and exterior of the bag 3002. For example, if a morcellation instrument, such as a scalpel, power morcellator, or grasper, accidentally punctures the proximal end of the balloon 3042 facing the interior of the bag 3002, the balloon 3042 may deflate, but the overall integrity of the bag 3002 is not compromised because the containment barrier to the exterior or sidewall of the bag remains intact. In essence, the balloon 3042 provides a double wall that provides additional protection at the base location where it is likely to be struck by a sharp instrument during morcellation. The inflatable base of the bag 3002 also provides a pedestal effect for the tissue specimen 3006, even if the center of the tissue 3006 is not located on top of the balloon 3042. Additionally, the inflatable base of the bag 3002, when in an inflated state, provides a moat for bodily fluids, such as blood, to escape from the specimen 3006. When inflated, the inner wall of the balloon 3042 is significantly spaced further from the outer wall of the double-walled structure of the base, thereby keeping the outer wall clear of instruments and more likely to remain intact in the event of a breach in the inner wall. A double-walled sidewall may be used throughout the bag 3002, not just at the base. The breach and resulting deflation of the balloon 3042 provides a visual notification to the user that a sharp instrument has struck the balloon, alerting the user and ensuring the safety of the outer wall as they proceed with removal with special care. This is in contrast to a single-wall configuration, which means that a breach in the sidewall is a breach in the exterior of the bag 3002 without warning. After the specimen 3006 is raised to the surface, the specimen 3006 can be easily visualized from outside the body through the opening of the bag 3002, facilitating morcellation. The balloon 3042 can be any inflatable member, and such a balloon can be incorporated into the floor of the bag 3002. As morcellation is performed, the tissue decreases in size. This can result in the specimen becoming lost within the bag 3002 and being difficult to find with morcellators and instruments.Inflating the balloon 3042 lifts the tissue 3006 closer to the end of the morcellator and instrument, thereby allowing much easier access to the tissue sample 3006.

[0133] 142A-142C and 143A-143D, another configuration of a containment bag 3002 with inflatable sidewalls is shown. The bag 3002 has sidewalls formed with an open top that serves as a mouth or entryway 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 also attached approximately midway below the bag 3002. The second bag ring 3040 serves as an anchor that can shorten the bag 3002 while simultaneously retracting the wound to its maximum potential opening. The bag 3002 has air channels 3008 to aid in the expansion of the lower portion of the bag 3002 containing the specimen. By expanding the lower portion, the visibility of the specimen from the top side is greatly enhanced. This also helps increase the speed at which morcellation can be performed. The bag 3002 is attached to a forked shaft 3028. The forks are semi-rigid. The purpose of the delivery shaft 3028 is to allow the bag 3002 to be manipulated with precision and great ease. The system can be deployed through the body wall 3056 into the abdomen or elsewhere in the body or into a bodily orifice. A tissue sample 3056 is placed into the bag 3002, and the bag 3002 is retrieved through the abdominal wall 3056. To retrieve the bag 3002, the forked shaft 3028 is pulled through the trocar until a corner of the bag 3002 is inserted into the trocar. Once the bag 3002 is engaged with the trocar, it can be pulled up to the surface, as shown in FIG. 143A. Once at the surface, the forked shaft can be removed from the first semi-rigid bag ring 3004. The entire bag 3002 does not pass through. Only the semi-rigid first ring 3004 and a portion of the side wall reach the surface. The cross section of the semi-rigid bladder ring 3004 allows for shortening of the bladder 3002 by a rolling technique as shown by the arrows in FIG. 143C. This not only shortens the bladder 3002 as shown in FIG. 143C, but also aids in wound retraction. A second bladder ring 3040 located at the bottom center of the bladder 3002 acts as an anchor to allow maximum retraction of the wound opening.This allows the morcellator to gain greater access to the tissue 3006. The bag 3002 performs both containment and retraction functions. Once the wound is retracted, the air channels 3008 can be inflated, as shown in FIG. 143D, with the optional tissue guard 200. The air channels 3008 expand outward, creating a free space around the tissue 3006, allowing the tissue 3006 to lie within the free space. The free space allows the tissue 3006 to roll and move as it is being morcellated. Once the bag is in place, morcellation can begin. Once a sufficient amount of tissue 3006 has been removed, the bag 3002 can then be removed from the patient. In another embodiment, the base of the bag 3002 can also be inflatable, as described above with reference to FIGS. 140 and 141, for example.

[0134] 144A-144C and 145A-145D, another configuration of containment bag 3002 having an inflatable sidewall is shown, with only a first bladder ring 3004 and no second bladder ring 3040. The bladder 3002 has an open top, with a semi-rigid first bladder ring 3004 attached at the top. The bladder 3002 utilizes air channels 3008 to aid in the expansion of the lower portion of the bladder 3002 containing the specimen 3006. The air channels 3008 are circumferentially disposed around the periphery of the bladder at the lower portion of the bladder. The air channels 3008 are interconnected and connectable to an inflation pressure source. Positive inflation pressure inflates the channels, and negative pressure acts to actively deflate the channels 3008. The deflated configuration is shown in FIG. 145A, and the inflated configuration is shown in FIGS. 145B-145D. In one configuration, the proximal-most air channel, the air channel closest to the bag opening, is annular and larger than the other air channels. The air channel 3008 is a tubular ring-shaped lumen that may be configured to be fluidly coupled to one or more adjacent tubular ring-shaped lumens and connectable to an inflation fluid source. This proximal-most first annular ring-shaped air channel lumen provides a counteracting force on the underside of the abdominal wall to enable significant retraction when the upper bag ring 3004 is rotated down on itself, thereby creating retraction. Thus, the first annular ring-shaped lumen acts similarly to a second bag ring 3040 of the same configuration. Additionally, expanding the lower portion significantly enhances the visibility of the specimen 3006 from the apical view. This also helps to increase the speed at which morcellation can be performed. The bag 3002 is attached to a forked carrying shaft 3038. The forks are semi-rigid. The purpose of the carrying shaft 3038 is to allow the bag to be manipulated with great precision and with great ease. The system may be deployed in the abdomen by a trocar. The specimen 3006 is placed into the bag 3002 and the bag 3002 is passed through the abdominal wall and retrieved.To retrieve the sack 3002, the forked shaft is pulled through the trocar until a corner of the sack is inside the trocar. Once the sack 3002 is engaged with the trocar, the sack can be pulled up to the surface. The entire sack does not pass through. The semi-rigid sack ring 3004 and a portion of the sack side wall are the only portions that reach the surface, as shown in FIGS. 145A-145D. Once at the surface, the delivery shaft can be removed from the semi-rigid sack ring 3004. The cross section of the semi-rigid sack ring 3004 allows for the sack 3002 to be shortened by a rolling technique, as indicated by the arrows in FIG. 145D. This rolling action not only shortens the sack 3002 by rolling the sack side walls, but also aids in wound retraction. The sack 3002 is then inflated. The sack 3002 may be inflated prior to rolling, as shown. The first annular air channel 3008, located in the lower center of the bladder, acts as an anchor to allow maximum retraction of the wound opening, thereby allowing for increased access to the tissue by the morcellator. The air channels 3008 expand outward, creating a free space around the tissue 3006, allowing the tissue 3006 to lie within the free space. The free space allows the tissue 3006 to roll and move as it is being morcellated. Once the bladder 3002 is in place, morcellation can begin. Once a sufficient amount of tissue 3006 has been removed, the bladder 3002 can then be removed from the patient. In another embodiment, the base of the bladder 3002 may also be inflatable, as described above, for example, with reference to FIGS. 140 and 141.

[0135] A wide variety of materials can be used for the bladder and semi-rigid ring. It may be desirable to use multiple materials in the same bladder, such as a hybrid of polymer and woven fabric. The semi-rigid ring can be made from a number of soft polymeric materials, including, but not limited to, pellethane, silicone, KRATON polymer, IROGRAN polyester-based thermoplastic polyurethane, metal, polymer, plastic, rubber, etc.

[0136] Any of the containment bags described herein, including the inflatable bag 3002, may be used with a guard or shield configured to be positionable within the bag 3002 to protect the bag sidewalls and adjacent tissue edges from sharp manual or powered morcellation instruments. Additional guard embodiments are shown in FIGS. 146-148. FIGS. 146A and 146B show a cylindrical, rigid guard 3047 having a rounded proximal end 3048 and a flared, funnel-shaped distal end 3050. The funnel-shaped guard 3047 serves to funnel or gather 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 sidewalls of the bag 3002, thereby creating clearance for morcellation and preventing the specimen bag from striking the blade. The guard 3047 may further include a spring-loaded guard feature that prevents the blade from being exposed when not engaging tissue, allowing for safe handling of the morcellator. The blade guard may be adapted to work in conjunction with the spring-loaded guard.

[0137] 148A and 148B, the guard 3047 has an inverted funnel or retracting guard at its distal end, with a central lumen that narrows toward the distal end 3050. The retracting guard 3047 allows for easy coring of the tissue 3006. The blade guard 3047 is cone-shaped, with a narrow end 3050 facing in the same direction as the leading edge of the morcellation tool blade. The guard 3047 spreads the surrounding tissue apart and pushes it to one side once the blade engages the surrounding tissue 3006.

[0138] Referring now back to FIGS. 147A and 147B, another configuration 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 clumped tissue 3006 from getting caught in the rotating blade and tube when a powered morcellator is used. If the tissue 3006 rotates with the blade, there is no relative blade motion, and therefore the blade does not cut the tissue. The anti-rotation studs 3052 may be external studs 3052 that extend outward from the outer surface of the guard 3047. These protrusions stop the guard 3047 from rotating. The internal anti-rotation studs 3052 also help guide and direct the tissue 3006. The studs 3052 can have a variety of shapes and sizes. This feature can be adapted to work with any guard. In another configuration, a bipolar vertical tissue separator can be provided within the guard. The bipolar vertical tissue separator feature functions to sever the tissue core from the mass. This alleviates the problem of being unable to separate the cored and morselized core from the larger mass. This feature can be adapted to cooperate with any blade guard. A light can also be provided with the guard 3047 and can be integrally formed therewith. The purpose of the light source, e.g., an LED, is to enhance and improve visibility within the tissue pouch 3002 for enhanced scope visibility. This feature can be adapted to cooperate with any blade guard. The configuration of FIGS. 147A and 147B further includes a plurality of holes 3054 extending across the guard 3047. These holes 5054 serve as vacuum bypass holes 3054 configured to prevent the pouch 3002 from being drawn into the blade when the tissue 3006 is drawn from the pouch 3002 using vacuum, for example, with a vacuum-powered morcellation system. This is accomplished by providing exposed radial holes 3054 around the permanent guard 3047. Once the blade is engaged with tissue, the vacuum bypass holes will not adversely affect the vacuum interface with the tissue. This feature may be adapted to work with any blade guard used under vacuum.

[0139] Morcellation is performed manually by the surgeon using a scalpel or electrosurgical instrument. Rather than utilizing a powered morcellator, any type of bag described herein is used with the manual morcellation method. The bag is inserted into the body cavity through the incision. The target tissue is placed into the bag, and the bag opening is pulled through the incision. A bag guard of the type described herein is inserted into the bag and held near the bag opening, 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 grasper, pulls it toward the opening, and places it in the guard's location. The surgeon then uses a scalpel, rather than a powered morcellator, to cut the tissue into small pieces and pull the pieces out of the body. The cutting is performed at and / or against the guard's location, so that the bag is not accidentally punctured by the scalpel. The bag, with small pieces of tissue or no tissue at all, is removed from the body cavity along with the bag guard.

[0140] The system includes a specimen collection container bag 3002 attached to a shaft. After the bag 3002 is deployed within the body and ablates the desired tissue 3006, the bag can capture the desired tissue 3006. Once the specimen 3006 is placed within the bag 3002, a semi-rigid ring 3004 attached to the bag opening can be pulled out of the body through a laparoscopic wound, incision, opening, or body access site. After the bag opening ring 3004 is pulled out of the patient's body, the lower bag portion remaining within the body cavity with the specimen 3006 has air channels 3008 that are inflated to counteract internal pneumoperitoneum pressure and provide an internal anchoring mechanism for the bag 3002. The outer bag opening ring 3004 is then rotated down on itself to retract the wound opening in the same manner as described above. The inflated portion of the bag 3002 remaining within the body cavity with the specimen 3006 is now exposed to the surface. Once the specimen bag 3002 is retracted into place, a morcellator 3000 with a central hollow rotating blade tube 3010 is attached to the bag opening ring. The morcellator 3000 is locked in a stationary position with the blade tube 3010 inserted down through the wound and into the lower region of the bag 3002 containing the specimen 3006. At that point, the morcellator 3000 is turned on, allowing the blade tube 3010 to rotate. Once the tube 3010 is rotated, tenacious hooks 3012 are inserted through the hollow rotating blade tube 3010 to grasp tissue and pull it up into the rotating blade tube 3010, which separates the large specimen 3006 into small core pieces that can be removed through a small laparoscopic incision site. The morcellator 3000 also includes a camera 3014 located at the distal end of the morcellator 3000 to visualize the interior of the specimen bag 3002. Once the tissue 3006 has been completely removed or reduced to a size sufficient to pull it through the wound site, the morcellator 3000 is removed from the bag ring, the bag 3002 is deflated, and finally the bag 3002 is pulled through the laparoscopic wound and the procedure is complete.

[0141] Referring now to FIG. 149, a system is shown including a powered morcellator 4000 and a bag 4002 coupled to the side of a morcellator shaft 4004. With further reference to FIGS. 150A-150D, the morcellator 4000 includes a handle 4006 coupled to the shaft 4004, with one or more rotating blades 4008 disposed at the distal end of the shaft 4004. The morcellator 4000 further includes a motor 4010 disposed within the handle 4006. The motor 4010 is coupled to and configured to rotate a gear pinion 4012. The gear pinion 4012 is further coupled to a gear train including an inner gear tube 4014 and an outer gear tube 4016. The outer gear tube 4016 is further coupled to a spacer 4018, which is coupled to an outer shaft 4020. The distal end of the outer shaft 4020 is coupled to the blade 4008. The gear inner tube 4014 is coupled to the inner shaft 4026, which is coupled to the second blade 4022. The gear outer tube 4016 and the gear inner tube 4014 are configured to counter-rotate to create counter-rotating blades at their distal ends. In counter-rotating tubes, there are two tubes, one 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 concept of counter-rotating tubes is to double the relative velocity experienced by the tissue compared to the overall blade. Whatever the tube configuration, this can include an outermost tube that retains the 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 the outer tube is configured to rotate. The concept of a stationary inner tube is to create a smooth member that allows for easy tissue advancement up the working channel. In another version, a single outer tube rotates, and there is only one tube with a blade attached at the end. The interior of the tube is featureless and smooth. In another version, three tubes are provided, with the inner and outer tubes stationary and the middle tube rotating.A blade is attached to the end of the intermediate rotating tube, and the blade extends beyond the inner and outer tubes. The stationary outer tube protects the tissue from any chafing by the rotating intermediate tube. The stationary inner tube facilitates easy tissue advancement up the tube. In another embodiment, a corrugated tissue advancement tube is provided for any tube configuration that rotates and provides unimpeded contact with tissue on its inner surface. A corrugated pattern is formed on the inner surface of the rotating tube, and the corrugated tube exerts an axial force on the morselized tissue, advancing it upward and away from the blade. In yet another embodiment, an auger-type tissue advancement tube is provided for any rotating inner tube configuration. The tube has multiple grooves extending the interior length of the tube. The ends of the grooves grip the tissue and advance it upward along the grooves, away from the blade. As can be seen in Fig. 150C, the counter-rotating tubes 4020, 4026 are driven from a single gear 4012, and an overmolded or quadring seal 4046 is provided to seal the tubes as shown in Fig. 150B. The electric motor is entirely contained within the handle 4006 and may be battery powered or connected to an external power source.

[0142] A spring-loaded blade guard 4024 operates to cover and expose the blades 4008, 4022, and a trigger 4028 operates to activate the motor 4010. The spring-loaded blade guard 4024 operates to expose only the blade 4008 once tissue contacts the end of the blade guard for added safety. The shaft of the blade guard 4024, including the opening and proximal portion, can be removable, and the blade guard 4024 can be non-rotating. The inner shaft 4026 and outer shaft 4020 are concentric and define a working channel 4030 below the midsection. A conical funnel 4032 is provided at the proximal end to facilitate insertion of an instrument, such as a grasper, into the working channel 4030. The proximal end of the morcellator 4000 can also be configured to connect to a specimen container 4034, shown in FIG. 151 , and a vacuum source for removal of the morcellated specimen. The specimen container 4034 is a transparent vessel having an inlet port 4038 and a port 4040 on the removable lid that can be connected to a vacuum source. The port 4040 that is connected to the vacuum source can have a valve for turning the vacuum on or off, and can be configured to be electronically actuated. The proximal end of the morcellator 4000 is also configured to be connected to a seal assembly 4042, as shown in FIG. 150D. The seal assembly 4042 can include a zero seal and a septum seal that seal against an instrument inserted into an opening at the proximal end of the seal assembly 4042. The seal assembly 4042 can further include a port 4044 that can be connected to a source of fluid under pressure. The blade guard 4024 has at least one side slot or side window opening 4036 configured to expose the blade through the side of the morcellator 4000 to receive tissue to be morcellated into the working channel 4030 through the side of the morcellator 4000. The blade guard 4024 can be rotated or retracted to cover and close the side opening or to expose the blade at the distal opening to receive tissue to be minced into the working channel 4030 at the distal end opening.

[0143] Referring now to FIG. 152 , a bag 4002 configured for attachment to a morcellator shaft 4004 having a side opening 4036 will now be described. In one form of the bag 4002, the bag 4002 has an open top 4048 with a closure 4050. The morcellator shaft 4004 has a rounded end, such that the morcellator shaft 4004 is adapted to be coupled to the bag 4002. The side of the morcellator shaft 4004 has a window-like opening 4036. The specimen retrieval system is introduced into the body, for example, via a trocar or through an open wound or body orifice. The bag 4002 is then opened, and the tissue sample is placed into the bag 4002. The bag 4002 is then sealed with a closure 4050. The morcellator shaft 4004 can be attached to the morcellator 4000, and morcellation can begin. Alternatively, a bag tube 4066 may be provided and the morcellator 4000 may be easily attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in FIGS. 152 and 159. The bag 4002 may also be pre-attached to the bag tube 4066. Once the specimen is reduced, the specimen collection system is removed from the patient. An example of a morcellator is described in U.S. Patent Application Nos. 12 / 102,719 and 13 / 659,462, filed April 14, 2008 and October 24, 2012, respectively, which are hereby incorporated by reference in their entireties as if set forth herein.

[0144] Various bag closure means will now be described with reference to FIGS. 153-157. In FIGS. 153A and 153B, a drawstring 4052 located at the bag top 4048 is used to close the open top 4048. In FIGS. 154A and 154B, a Ziplock® or zipper-style closure 4054 is provided, which uses a slider to lock and unlock two sides of the closure to open and close the top 4048. In FIGS. 155A-155C, an alternative closure means includes a grommet 4056 formed in the bag 4002 near the bag top 4048. A grasper 4058 or other device is inserted into the opening of the grommet 4056 to open it, and then twisted to roll the bag 4002 down and close the open top 4048, as shown in FIG. 155C. In Figures 156A and 156B, the top 4048 includes a hook-and-loop fastener 4060. Opposite sides of the hook-and-loop fastener are brought together to close the open bag top 4048. In Figures 157A and 157B, the bag top 4048 includes a plurality of grommet openings 4062. Specifically, four openings 4062 are provided. For example, an instrument, such as a grasper 4058, can be used to grasp all of the openings 4062, and then the grasper can be twisted to wrap the openings closed as shown in Figure 157B.

[0145] To protect the bag 4002 and prevent it from entering the side slot 4036 in the morcellator shaft 4004 and contacting the rotating blade 4008, a plastic guard 4064 is provided, as shown in FIGS. 158A-158E. The plastic guard 4064 is made from a single piece of semi-rigid plastic and is configured to be folded and inserted into the morcellator slot 4036. The plastic guard 4064 is made from a material that is more rigid than the bag 4002 and is configured to surround the side opening 4036 and provide a trough- or funnel-shaped opening to expand the bag 4002 away from the opening 4036. The bag 4002 is attached to the distal end of the morcellator shaft 4004. The bag 4002 has an open top 4048 with a closure 4050. The bag 4002 is provided at the side opening 4036 of the morcellator shaft 4004 and has a semi-rigid structure that allows tissue to be easily placed into the bag 4002. The specimen retrieval system is introduced into the body through a trocar or open wound, or a body orifice, or other delivery mechanism. The bag 4002 is then opened and the tissue sample is placed into the bag 4002. The bag 4002 is then sealed with a closure 4050. The morcellator 4000 is attached to the proximal end of the morcellator shaft 4004 and morcellation begins. Alternatively, a bag tube 4066 is provided and the morcellator 4000 is attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in FIG. 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 morcellator shaft 4004 and bag tube 4066 are frictionally held together by a knob attached to the bag tube 4066. The knob has an interference fit with the morcellator handle in a snap-fit ​​or friction-fit engagement. Once the specimen is reduced, the specimen retrieval system is removed from the patient. The semi-rigid structure of the guard 4064 may be made of spring steel, nitinol, or molded plastic.The bag 4002 can be closed using a drawstring method or by pinching the ends and wrapping the bag structure to close the bag 4002, in all three configurations of material. In another form shown in FIG. 160 , the bag 4002 is attached to a bag tube 4066. The bag 4002 has a closed end. An opening 4068 of the bag 4002 is located on the side of the bag 4002. The bag 4002 also has a semi-rigid structure at the opening that facilitates the placement of tissue into the bag. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a fenestrated section 4070. The specimen retrieval system is introduced into the abdomen via a trocar or open wound. The bag 4002 is then opened and the tissue specimen is placed into the bag 4002. The bag is then sealed, the morcellator 4000 is attached, and morcellation begins. Once the specimen is reduced in size, the specimen retrieval system is removed from the patient. The side opening 4068 may have a spring steel, nitinol, or molded plastic reinforcement disposed midway along the side wall of the bag 4002. The side opening 4068 springs open to an oval shape, thereby facilitating specimen tissue insertion into the bag 4002. All three configurations of material allow the bag to be closed by using a drawstring method or by pinching the ends and rolling the structure to close the bag 4002. In another form, the spring steel, nitinol, or molded plastic is disposed near the bag tube 4066 as shown in FIG. 161 .

[0146] In another embodiment, shown in FIGS. 162A-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 a plastic material. Various closure means 4050, such as a drawstring 4052 or a pinch and roll down method, can be used to seal the larger end 4072 of the bag 4002. The smaller end 4074 has a spring steel or nitinol clamp 4076 attached to the bag tube 4066. The clamp 4076 fits around the rigid blade guard 4064. The tapered edge of the rigid blade guard 4064 helps prevent the clamp 4076 from seating against the rim and slipping off the bag tube 4066. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a fenestrated section 4070. First, the bag 4002 is introduced into the abdomen through an opening, body orifice, or open wound, using a trocar, delivery shaft, instrument, or other deployment method. The larger diameter end 4072 of the bag is then opened and positioned around the tissue sample 4078. The larger diameter end 4072 of the bag 4002 is then sealed. The bag tube 4066 is then introduced into the body. The bag 4002 is then attached to the bag tube 4066 with a clamp 4076. The morcellator 4000 is attached and morcellation begins. Once the specimen 4078 has been reduced, the collection system is removed from the patient.

[0147] In another embodiment shown in FIGS. 163A-163C, the bag 4002 is attached to a bag tube 4066, referred to as 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 distal end of the sheath has two holes that facilitate manipulation of a nitinol or other flexible, semi-rigid drawstring 4052 to open and close a semi-rigid bag opening 4068. The sheath also has two channels parallel to the axis of the tube to facilitate retrieval of the nitinol. The side of the tube has a fenestrated section 4070. A specimen retrieval system is introduced into the body through the opening, as shown in FIG. 163B. The bag 4002 is then opened by loosening the drawstring 4052, and the tissue sample 4078 is retrieved by enclosing it in a net created by the nitinol and the bag 4002. This can be done with or without the aid of a grasper or dissector. Once the tissue 4078 is enclosed, the nitinol can be retrieved proximally by the drawstring 4052, which closes the bag 4002 around the tissue sample 4078, sealing the bag 4002. The morcellator is attached and morcellation begins. Once the specimen 4078 is reduced, the retrieval system is removed from the patient.

[0148] In another form, the bag 4002 has an open top with a semi-rigid ring attached to the top. The bag 4002 can be tightly rolled and then deployed into the abdomen via a trocar. The bag 4002 is then internally opened by manipulation with a grasper. The specimen 4078 is placed into the bag 4002 and the bag 4002 is retrieved through the abdominal wall. The entire bag 4002 does not pass through. The semi-rigid bag ring is the only portion that reaches the surface while the rest of the bag remains within the abdominal cavity of the body. Morcellation can begin. Once a sufficient amount of tissue 4078 has been removed, the bag 4002 can then be removed from the patient.

[0149] 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 entryway into a patient, including, but not limited to, an incision site and a natural orifice. The target specimen is generally too large to be safely removed through the body orifice and must be manipulated, for example, by cutting with a blade, in order to remove 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 into the bag, and the mouth of the bag is pulled outside the patient's body. A guard is placed into the mouth of the bag and seated across the body orifice, drawing the target specimen into the guard's lumen. While in the guard's lumen, the target specimen is within a protective morcellation zone, within which the surgeon can use a blade to reach and sever the target specimen for removal. The guard provides protection against a stray blade and also provides a direct cutting surface against which tissue can be placed for reduction. The overall length of the guard defines the length of the morcellation zone that protects the pouch and tissue at the margin of the body opening. In addition, a retractor can be used. The retractor can be integrally formed with the pouch or can be a separate, stand-alone device. The exemplary retractor described herein is a two-ring retractor with a flexible sidewall material disposed between the two rings. The retractor sidewall is configured to be wrapable around the first ring to retract tissue at the margin of the body opening. When a retractor is used, it can be placed within the pouch, between the marginal tissue and the pouch or between the pouch and the guard. The above description pertains to various uses of the guard, pouch, and retractor used in manual morcellation methods. In powered morcellation methods, the guard is inserted into the pouch and morcellation is performed. In another embodiment of powered morcellation, a stabilizing cap is coupled to the proximal ring of the bag or the proximal end of the guard to perform the powered morcellation. The stabilizing cap helps define the vertical position of the blade, thereby preventing the blade from extending beyond the predetermined morcellation zone within the guard or a short distance safely beyond the distal end of the guard.Another embodiment for powered morcellation uses a retractor, in which case the retractor is placed between the marginal tissue and the pouch, or between the pouch and guard as described above, and powered morcellation is performed. In the previous embodiment, a stabilizing cap can be used that is connected to the proximal ring of the retractor, the proximal ring of the pouch, or the proximal end of the guard, and morcellation is performed. In addition to the embodiments described above, when performing a procedure such as a hysterectomy, any one of the following approaches can be used in conjunction with any of the embodiments described above. In one embodiment, the pouch is placed inside the body through the vagina, the target specimen (e.g., uterus) is placed into the pouch while it is located within the body cavity, the mouth of the pouch is then pulled through the abdominal incision, the guard is inserted into the mouth of the pouch, and morcellation, removal, and pouch removal occur at the abdominal opening. In another embodiment, a pouch is placed inside the body through the vagina, the target specimen (e.g., uterus) is placed into the pouch while it is located within the body cavity, then the mouth of the pouch is pulled back through the vaginal canal, a guard is inserted into the pouch mouth, and morsel, removal, and pouch removal occur at the vagina. In yet another embodiment, the pouch is placed inside the body through an abdominal incision, the target specimen (e.g., uterus) is placed into the pouch while it is located within the body cavity, then the mouth of the pouch is pulled back through the vaginal canal, a guard is inserted into the pouch mouth, and morsel, removal, and pouch removal occur at the vagina. In another embodiment, the pouch is placed inside the body through an abdominal incision, the target specimen (e.g., uterus) is placed into the pouch while it is located within the body cavity, then the mouth of the pouch is pulled back through the abdominal incision, a guard is inserted into the pouch mouth, and morsel, removal, and pouch removal occur at the vagina. In other formats involving morsel of the uterus or other target specimen, the pouch 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 guard's central lumen, and morcellation and removal occurs at the abdominal incision. Alternatively, the target specimen (e.g., uterus) is accessed vaginally, a guard is placed within the vaginal canal, and the target specimen is dissected and pulled through the guard's central lumen, and morcellation and removal occurs at the vagina. As an alternative to pouchless abdominal access, the procedure can be viewed with a laparoscope inserted through the vagina.As an alternative to pouchless vaginal access, the procedure can be viewed with a laparoscope inserted through an incision in the abdomen.

[0150] In some cases, a guard is not used. In one such configuration in which a guard is not used, a pouch is placed into the body cavity via the vagina, the target specimen is placed into the pouch, the mouth of the pouch is pulled through an abdominal incision, a retractor can be placed into the pouch across the abdominal incision, and morsel, removal, and pouch removal occur at the abdominal incision. In another configuration in which a guard is not used, a pouch is placed into the body cavity via the vaginal canal, the target specimen is placed into the pouch, the mouth of the pouch is pulled back through the vaginal canal, a retractor can be placed into the pouch within the vaginal canal, and morsel, removal, and pouch removal occur at the vagina. In another configuration in which a guard is not used, a pouch is placed into the body cavity via an abdominal incision, the target specimen is placed into the pouch, the mouth of the pouch is pulled through the vaginal canal, a retractor can be placed into the pouch within the vaginal canal, and morsel, removal, and pouch removal occur at the vagina. In another configuration where a guard is not used, a pouch can be placed into the body cavity via an abdominal incision, the target specimen can be placed into the pouch, the pouch opening can be pulled through the abdominal incision, a retractor can be placed into the pouch within the vaginal canal, and morsel, removal, and pouch removal can occur at the abdominal incision. For any of the configurations where a guard is not used and a retractor is used, it is preferable to use any of the cut-resistant retractors described above. Also, for any of the configurations where a guard is not used and a retractor is used, a retractor can be placed between the pouch and the tissue margin. Also, for any of the configurations where a guard is not used and a retractor or no retractor is used, it is preferable to use any of the cut-resistant pouches described above. A powered morsel can also be used with any of the methods where a guard is used. In such cases, a stabilizing cap can be used to connect to the proximal end of the bag or the proximal ring of the retractor.

[0151] In a configuration in which 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 a side wall. The retractor is configured so that webbing can be wrapped around the first ring, thereby reducing the length of the retractor and retracting tissue edges. The bottom ring is inserted through a body opening and is positioned within the patient, while the top ring of the retractor is positioned above the patient. The top ring is turned / flipped over on itself like a bag, drawing the lower ring of the retractor closer and creating a taut relationship between the side walls. The lower ring of the retractor advantageously retracts the portion of the bag within the patient, 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 orifice to retract the bag and tissue margins, with the first ring of the retractor and the mouth 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 positioning of the bag between the retractor and the tissue margins at the body orifice secures the bag to the patient's body. In one form, only the distal portion of the approximately 4-inch (10.16 cm) long webbing is cut-resistant and made of KEBLAR, DYNEEMA, or other cut-resistant material, while the proximal portion of the webbing is not made of a cut-resistant material but is made of polyurethane or other soft film. This configuration allows the proximal end of the webbing to be easily wrapped around the first ring during retraction. When the length of the webbing is reduced by rolling, the distal cut-resistant portion of the webbing is brought into position to protect the proximal end or first ring of the retractor and to protect the morcellation to be performed. With less cut-resistant material, which can be thick and bulky, the retractor is less expensive and easier to turn and rotate the first ring because the less 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 configuration for intravaginal use, only the proximal portion of the webbing, approximately 5 inches (12.70 cm) long, is cut-resistant and is made of KEBLAR, DYNEEMA, or other cut-resistant material, while the distal portion of the webbing is not made of a cut-resistant material but is made of polyurethane or other soft film to increase flexibility and provide anchorage at the proximal end. In vaginal surgical procedures, such as a total laparoscopic hysterectomy, the first ring at the proximal end does not need to roll down on itself to the same extent. Therefore, the proximal end of the webbing is made of a cut-resistant material compared to abdominal surgical procedures, where the webbing is wrapped around the first ring much less and the proximal end is not made of a cut-resistant material.

[0152] In accordance with one aspect of the present invention, a contamination prevention system for manual or powered field morcellation is provided, comprising a containment bag having a mouth and a shield configured for removably insertion into the mouth of the bag, the shield having a central lumen that provides a working channel for morcellation and protects the bag and surrounding tissue.

[0153] In accordance with another aspect of the present invention, there is provided an instrument for safely removing a tissue specimen from a body cavity through a body opening smaller than the tissue specimen, the instrument including a removable shield configured to be secured within the body opening, the instrument further including a pouch or retractor disposed between the body opening and the shield.

[0154] In accordance with another aspect of the present invention, a shield is provided having side walls defining a central opening, the shield having a C-shaped concave outer surface that anchors the shield within the body opening.

[0155] In accordance with 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 a body opening. The shield is segmented so that one portion of the shield nests within another portion of the shield, and the shield is expandable from a reduced lateral configuration to an expanded lateral configuration, or vice versa, by changing the nesting portion of the shield.

[0156] In accordance with another aspect of the present invention, there is provided an expandable shield having sidewalls defining a central opening, the shield being movable between a first configuration and a second configuration, the first configuration having a dimension that is greater than the dimension in the second configuration, the dimension being a vertical and / or lateral dimension.

[0157] In accordance with another aspect of the present invention, there is provided a system for preventing the potential spread of cancerous cells when removing a large tissue specimen through a small body opening. The system includes a container and a morcellation zone. The morcellation zone can be inserted into and removed from the container. The morcellation zone protects the container from penetration by a morcellation instrument.

[0158] In accordance with another aspect of the present invention, a shield is provided having a blade coupled to the shield, the blade movable along a predetermined path relative to the shield, the shield surrounding at least a portion of the predetermined path to protect tissue surrounding a body opening.

[0159] Referring now to FIGS. 164-167, a shield 5000 of the present invention is shown. The shield 5000 includes a band of soft, cut-resistant material. The shield 5000 has an inner surface 5002 and an outer surface 5004 interconnected by a top end 5006, a bottom end 5008, a first end 5010, and a second end 5012. The band is configured to define a central lumen having a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The lumen diameter may vary along the longitudinal axis. For example, the inner surface 5002 may be shaped, such as convex, such that the central lumen is larger at the apex 5006 and bottom 5008 ends relative to the lumen diameter at the center or waist of the band, as shown in FIGS. 164-167. In one form, the inner surface 5002 defines a constant lumen diameter from the apex 5006 to the base 5008 or exhibits a chevron or funnel-like shape or other curve or shape. The outer surface 5004 substantially conforms in shape to the inner surface 5002 to define a band of substantially uniform thickness, although the invention is not limited thereto and the outer surface 5004 can assume a different shape than the inner surface 5002 and / or have a different band thickness along the longitudinal axis. The curved, funnel-like, or C-shaped, concave shape of the outer surface 5004 described herein above, helps to anchor the shield 5000 at the tissue margins when inserted into a body orifice, incision site, or other opening. Additionally, the larger diameter shape at the apex 5006 helps to provide a cutting board surface for performing manual morcellation and protecting the surrounding tissue. For example, a flat, planar orientation of the apex 5006 with the inner surface 5002 facing upward and perpendicular or nearly perpendicular to the longitudinal axis and the outer surface 5004 facing downward onto the tissue, e.g., downward onto the abdominal wall, creates a large protective overlay or a large cutting board-like surface. As shown in the embodiment of FIGS. 164-167, the outer surface of the band has a recess or curvature extending circumferentially around the guard from the apex 5006 to the bottom 5008 along the longitudinal axis.The shield 5000 is made of a soft, resilient material, such as plastic, and is molded to have a rest configuration that defines a rest lumen diameter. The rest configuration is shown in FIGS. 164-166, in which a gap is created between the first end 5010 and the second end 5012. The gap is approximately 5-10° with an arc length of approximately 4-6 mm. The rest lumen diameter at the waist is approximately 40 mm. Because the shield 5000 is resilient and soft, its lumen diameter can be adjusted by flexing the band inward and turning it on itself to decrease the gap, thereby overlapping the first end 5010 and the second end 5012 of the band and decreasing the lumen diameter, or by flexing the band outward and bending it on itself to increase the gap and increase the lumen diameter relative to the rest lumen diameter. Due to the increase or decrease in lumen diameter relative to the rest lumen diameter, the band tends to spring back toward approximately the rest configuration and rest lumen diameter due to its resilience. In one form, the rest form does not include a gap. As the diameter of the band is reduced, the first end 5010 overlaps the second end 5012 to form a spiral shape when viewed from above or below. The outer surface 5004 of the band at the first end 5010 faces at least a portion of the inner surface 5002 of the band at the second end 5012, such that the portion of the band near the first end 5010 telescopes within the portion of the band near the second end 5012. To accommodate the telescoped first end portion of the band, the second end portion is configured to curve outward a distance 5014 approximately equal to the width of the band wall, i.e., the width of material between the inner surface 5002 and the outer surface 5004, which is approximately 1-3 mm, so that as the band telescopes, the inner surface 5002 maintains a large inner diameter that is not reduced by the overlapping segments of the band where the overlap exists, yet the inner surface becomes substantially flush at the intersection, as can be seen in FIG. 167. A ridged inner surface 5016 is formed in the shield 5000 by an outwardly extending jog or irregularity created on the inner surface of the band due to the increase in lumen diameter.The increased lumen diameter extends from the ridge inner surface 5016 along a portion of the circumference of the band to the second end 5012. The inner ridge 5016 is formed approximately 127° from the second end 5012. The inner ridge 5016 is formed relative to the inner surface 5002, and extends substantially perpendicularly from the inner surface 5002 in a longitudinal direction from the apex end 5006 to the bottom end 5008. The inner ridge 5016 forms a corresponding outer ridge 5018 when the band is shaped to form a jog at the inner ridge 5016, where the band increases in inner diameter a segmental distance 5014 of approximately 127° around the circumference from the inner ridge 5016 to the second end 5012. At least one abutment is formed between the inner ridge 5016 and the second end 5012 and extends along the longitudinal axis between the top end 5006 and the bottom end 5008 .

[0160] A first inner abutment 5020 is formed on the inner surface 5002. The surface of the first inner abutment 5020 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outward from the inner surface 5002 along the longitudinal axis between a top end 5006 and a bottom end 5008. The first inner abutment 5020 has a height from the inner surface 5002 that is approximately equal to or greater than a thickness of the band material between the inner surface 5002 and the outer surface 5004. When the first end 5010 overlaps the second end 5012 and the outer surface 5004 at the first end 5010 faces over the inner surface 5002 at the second end 5012 in the first, contracted configuration, the first end 5010 is configured to contact the first inner abutment 5020 to lock the dimension of the inner diameter and prevent further reduction in this dimension. This configuration serves to lock the shield 5000 into a fixed diametric / lateral dimension position, with the shield 5000 maintaining a certain number of degrees (°) of circumferential overlap around a portion of the circumference of the shield 5000. This lock is particularly useful when the shield 5000 is placed within an opening or incision, where tissue forces tend to collapse the central lumen, further reducing the inner diameter. The central lumen serves as a working channel, and the lock is created when at least a portion of the shield 5000 contacts the first inner abutment 5020. The first inner abutment 5020 is located approximately 30° from the second end 5012. When the first end 5010 contacts the first inner abutment 5020, the inner diameter is approximately 36 mm.

[0161] The shield 5000 further includes a second inner abutment portion 5022 disposed a long distance from the second end 5012. Specifically, the second inner abutment portion 5022 is disposed approximately 65° from the second end 5012. The second inner abutment portion 5022 is formed on the inner surface 5002. The surface of the second inner abutment portion 5022 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outward from the inner surface 5002 along the longitudinal axis between the top end 5006 and the bottom end 5008. The second inner abutment portion 5022 has a height from the inner surface 5002 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. The first inner abutment portion 5020 and the second inner abutment portion 5022 are substantially parallel. When the first end 5010 overlaps the second end 5012 and the outer surface 5004 at the first end 5010 faces over the inner surface 5002 at the second end 5012 in the reduced diametric / lateral configuration, the first end 5010 is configured to contact the first inner abutment portion 5020 or the second inner abutment portion 5022 to lock the inner diameter dimension and prevent further reduction in this dimension. The second inner abutment portion 5022, like the first inner abutment portion 5020, serves to lock the shield 5000 in a fixed diametric / lateral dimension position with the shield 5000 maintaining a certain number of degrees of overlap circumferentially around a portion of the circumference of the shield 5000. This lock is particularly useful when the shield 5000 is placed within an opening or incision, where tissue forces tend to collapse the central lumen and further reduce the inner diameter. The central lumen serves as a working channel, and locking is created when at least a portion of the shield 5000 contacts the second inner abutment 5022. When the first end 5010 contacts the second inner abutment 5022, the inner diameter is approximately 33 mm. When the first end 5010 contacts the second inner abutment 5022, the first inner abutment 5020 rests against the outer surface 5004. A first outer abutment 5024 or receiving area 5024 is formed on the outer surface 5004 to receive the first inner abutment 5020.In one embodiment, as shown, the receiving area 5024 is formed with an abutment portion, while in another embodiment, the receiving area is not configured with an abutment surface. The first outer abutment portion 5024 is disposed approximately 30° from the first end 5010. The first outer abutment portion 5024 is formed on the outer surface 5004. The surface of the first outer abutment portion 5024 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends inward from the outer surface 5004 along the longitudinal axis between the top end 5006 and the bottom end 5008. The first outer abutment portion 5024 has a height relative to the outer surface 5004 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. The first outer abutment portion 5024, the first inner abutment portion 5020, and the second inner abutment portion 5022 are substantially parallel. When the first end 5010 overlaps the second end 5012 and the first end 5010 contacts the second inner abutment 5022, the first inner abutment 5020 faces and contacts the first outer abutment 5024, thereby locking the size of the inner diameter and preventing further reduction in this size.

[0162] The shield 5000 further includes a third inner abutment portion 5026 disposed a long distance from the second end 5012. Specifically, the third inner abutment portion 5026 is disposed approximately 100° from the second end 5012. The third inner abutment portion 5026 is formed on the inner surface 5002. A surface of the third inner abutment portion 5026 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outward from the inner surface 5002 along the longitudinal axis between a top end 5006 and a bottom end 5008. The third inner abutment portion 5026 has a height from the inner surface 5002 that is approximately equal to or greater than a thickness of the band material between the inner surface 5002 and the outer surface 5004. The first inner abutment portion 5020, the second inner abutment portion 5022, and the third inner abutment portion 5026 are substantially parallel and approximately equally spaced around the circumference of the inner surface 5002. When the first end 5010 overlaps the second end 5012 and faces over the inner surface 5002 at the second end 5012 when the outer surface 5004 at the first end 5010 is in the reduced diameter / lateral configuration, the first end 5010 is configured to contact either the first inner abutment portion 5020, the second inner abutment portion 5022, or the third inner abutment portion 5026 to variably adjust the inner diameter and then lock the size of the inner diameter to prevent further reduction in this size. The third inner abutment portion 5026, like the first and second inner abutment portions 5020 and 5022, serves to lock the shield 5000 in a fixed diametrical / lateral dimension position, with the shield 5000 maintaining a certain number of degrees (°) of circumferential overlap around a portion of the circumference of the shield 5000. This locking is particularly useful when the shield 5000 is placed within an opening or incision, where tissue forces tend to collapse the central lumen, further reducing the inner diameter. When the first end 5010 contacts the third inner abutment portion 5026, the inner diameter is approximately 30 mm. When the first end 5010 contacts the third inner abutment portion 5026, the first and second inner abutment portions 5020 and 5022 are positioned against the outer surface 5004.A first outer abutment portion or receiving area 5024 is formed on the outer surface 5004, and a second outer abutment portion or receiving area 5028 is formed on the outer surface 5004 for receiving the first inner abutment portion 5020 and the second inner abutment portion 5022. In one form, the receiving area comprises an abutment surface, and in another form, the receiving area is sized and shaped to flushly receive the inner abutments. The second outer abutment portion 5028 is disposed approximately 65° from the first end 5010. The second outer abutment portion 5028 is formed on the outer surface 5004. A surface of the second outer abutment portion 5028 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends outward from the outer surface 5004 along the longitudinal axis between a top end 5006 and a bottom end 5008. The second outer abutment portion 5028 has a height from the outer surface 5004 that is approximately equal to or greater than the height of the inner abutment portion or the thickness of the band material between the inner surface 5002 and the outer surface 5004. The second outer abutment portion 5028, the first outer abutment portion 5024, the first inner abutment portion 5020, the second inner abutment portion 5022, and the third inner abutment portion 5026 are substantially parallel. When the first end 5010 overlaps the second end 5012 and contacts the third inner abutment portion 5026, the first inner abutment portion 5020 faces and contacts the second outer abutment portion 5028, and the second inner abutment portion 5022 faces and contacts the first outer abutment portion 5024, thereby locking the size of the inner diameter and preventing further reduction in this size.

[0163] The shield 5000 further includes a third outer abutment portion 5030 that is positioned at a greater distance from the first end 5010 than the second outer abutment portion 5028. Specifically, the third outer abutment portion 5030 is positioned approximately 100° from the first end 5010. The third outer abutment portion 5030 is formed on the outer surface 5004. The surface of the third outer abutment portion 5030 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends inward from the outer surface 5004 along the longitudinal axis between the top end 5006 and the bottom end 5008. The inward extension of the outer abutment portion creates a ramp-like surface on the inner surface 5002. The third outer abutment portion 5030 has a height from the outer surface 5004 that is approximately equal to or greater than the thickness of the band or inner abutment. The third outer abutment portion 5030 is configured to correspond and receive the first inner abutment portion 5020 when the first end 5010 abuts the inner ridge 5016 as shown in FIG. 167. In another form, the first end 5010 abuts a fourth inner abutment portion that is not configured as an inner ridge 5016 as described herein. The first inner abutment portion 5020, the second inner abutment portion 5022, and the third inner abutment portion 5026 are substantially parallel. When the first end 5010 overlaps the second end 5012 and the outer surface 5004 at the first end 5010 faces over and toward the inner surface 5002 at the second end 5012 in the reduced diameter / lateral configuration, the first end 5010 is configured to contact either the first inner abutment 5020, the second inner abutment 5022, the third inner abutment 5026, or the inner ridge 5016 to variably adjust the inner diameter and lock the size of the inner diameter, preventing further reduction in this size. In one configuration, all of the inner abutments, including the inner ridges, are substantially equally spaced. The first end 5010 is shown in FIG. 167 contacting the inner ridge 5016 to form the shield 5000 with its smallest relative inner diameter of approximately 28 mm.When the first end 5010 contacts the inner ridge 5016, the first inner abutment 5020, the second inner abutment 5022, and the third inner abutment 5026 are positioned against the outer surface 5004, and in particular are received within or against the third outer receiving area or abutment 5030, the second outer receiving area or abutment 5028, and the first outer receiving area or abutment 5024, respectively. To unlock the shield 5000, the inner telescoping segment, i.e., the first end 5010, of the shield 5000 is moved toward the longitudinal axis to disengage the abutment surfaces from one another. The first end 5010 is bounded by a marker 5032, such as a tab, a grip with a textured surface, or an area of ​​contrasting color located, for example, near the top end 5006 or the bottom end 5008, that serves as an indication to the user as to which end of the shield 5000 is fitted into the shield 5000 so that the abutments interlock accordingly. The marker 5032 also provides a textured location to facilitate removal or release of the shield 5000 from the locked configuration by pulling or grasping the shield. The marker 5032 can further serve directional purposes to instruct the user which side of the shield is facing up if the shield is asymmetrical along the longitudinal axis.

[0164] While the three inner abutments 5020, 5022, 5026, three outer abutments 5024, 5028, 5030, and one inner ridge 5016 have been described as having a particular spacing and angular relationship, the present invention is not so limited, and any number of inner abutments can be provided to provide a variable locking configuration and thereby achieve a desired inner diameter of the working channel. Additionally, while the gap is shown as being approximately 8° in the relaxed configuration, the present invention is not so limited, and the shield 5000 can have a greater, lesser, or even zero gap. As noted above, the shield 5000 is designed such that the first end 5010 serves as an abutment, specifically a functional locking edge, contacting one or more inner abutments 5020, 5022, 5026 and / or one or more inner ridges 5016 at a time to variably select and secure the inner diameter. In another form, the first end 5010 does not serve as a functional edge, but instead serves as a functional locking edge when the outer abutment contacts and abuts one or more of the inner abutments 5020, 5022, 5026. And in yet another form of the shield described above, the first end 5010 and one or more of the outer abutments 5024, 5028, 5030 serve as functional locking edges, where one or more abutments are in contact simultaneously at a fixed diametric position. Each inner abutment forms a triangular, angled protrusion from the inner surface 5002, and the outer abutment forms a correspondingly shaped, but larger, triangular, angled recess or protrusion into the outer surface 5004 configured to receive the smaller inner abutment, such that one or more inner abutment surfaces may simply be received within the receiving area with or without contacting one or more outer abutments. In one form, the shape of the inner and outer abutments may further include a friction-fit or snap-fit ​​configuration to further enhance the locking function, where the feature may include a ridge providing a lock, ledge, or gate with increased friction. The angled protrusion at the inner surface 5002 facilitates expansion of the shield from the contracted to the expanded configuration.For example, when inserting the shield into an incision / mouth, the shield 5000 is first curled or rolled into a reduced configuration so that the shield 5000 can fit into a small incision / mouth, and then the shield 5000 is stretched to a larger diameter configuration. As the reduced configuration is stretched to a larger diameter configuration, portions of the outer surface 5004 ride upward over and along the angled protrusions on the inner surface 5002. After the outer surface rides along the inner surface, the inner abutment contacts the outer abutment to create a first stop or locking position. The shield 5000 is then further stretched, causing the outer surface to ride over and along the inner surface protrusions at the location of the outer abutment to another locking position, where the inner and outer abutments contact each other, and so on. Thus, the shield expands in a ratcheting manner, with the diametric dimension gradually increasing in steps between locking interactions with one or more abutments. In one form, the shield 5000 does not have an outer abutment formed on its outer surface. Instead, the shield 5000 has a receiving area that receives an inner abutment overlaid by the outer surface to provide a flush, locked position, and the locking function is performed when the inner abutment contacts the first end 5010 or, in one form, one or more outer abutments formed on one or more receiving areas. Thus, the receiving areas not configured for an abutment formed on the outer surface 5004 can assume any shape at the outer surface. The inner surface opposite the receiving area can have a beveled or other curved configuration that facilitates movement of the shield between the contracted and expanded configurations. This beveled feature advantageously makes the shield 5000 easier to use because a separate step to mechanically unlock the locked configuration is not required when the shield is stretched to a larger diameter. Instead, the shield is simply curled or otherwise moved circumferentially so that it advances over the inner protrusions and ratchets into a locked position adjacent the abutments.

[0165] The shield 5000 shown in FIGS. 164-167 is adjustable to have four separate inner diameter sizes. When inserted into an incision or bodily opening, the shield 5000 provides protection and can fit incisions of approximately 1 inch (2.54 cm) or smaller. Of course, larger shields 5000 can be made to be placed in larger incisions / openings, such as the vaginal canal. Such shields can also be made to have lengths longer than those shown in FIGS. 164-167. The shield 5000 allows for tissue retraction at the incision / opening. When inserted into the incision / opening, the shield 5000 curls into a reduced configuration, thereby inserting into a smaller incision / opening, and then stretches into a larger diameter configuration with multiple locking positions that can be used to customize the locking position of the shield. Thus, the shield 5000 serves to perform the function of retraction, enlarging the incision or opening as the shield diameter and working channel expand. With the shield 5000 of Figures 164-167, the shield allows for retraction and can fit into incisions up to about 1.5 inches (3.81 cm) in diameter. Retraction of the surrounding tissue provides more working space and better stability for the user.

[0166] Additionally, the locking mechanism of the shield 5000 is unique because it utilizes radial pressure exerted externally on the shield 5000 and outer surface 5004. Thus, the shield, and particularly the shield's locking mechanism, in one form, functions when the shield is inserted into an incision of a size equal to or smaller than the inner diameter of the shield in its most contracted configuration. The surrounding tissue exerts a radial force circumferentially around the outer periphery of the shield 5000, which forces the first end 5010 to abut against one or more of the inner abutments or inner ridges and / or the one or more inner abutments to abut one or more outer abutments. The surrounding tissue edges exert a compressive force on the shield. The shield is configured to utilize a force component that contacts the periphery of the shield, thereby moving both the inner and / or outer and / or ridges and / or first edges of the vertical abutments to contact one or more other abutments or ridges, first edges, or other vertical structures, thereby preventing collapse of the shield while providing a locking feature. The structures of the shield that are perpendicular to the circumferential surface, such as the abutments / edges / ridges, support and reinforce the structure, making the shield stronger. Shield configurations with locking positions and configurations where two or more pairs of abutment surfaces are simultaneously in contact to contact the locking position make the shield stronger and able to withstand forces that tend to disrupt the position of retracted tissue. To retract tissue and further increase the radial strength of the shield while subjected to tissue pressure around the shield when in a tissue opening, any one or more of the abutments / ridges / edges forming the contact surfaces that perform the locking function may extend from at or near the apex 5006 to at or near the bottom 5008 or over a length at least equal to or greater than 50 percent of the surface length of the shield, the purpose of which is to provide strength and substantially uniform reinforcement along the length of the shield from top to bottom.Tissue pressure on the shield while it is positioned within the incision / mouth presses the leading edge and outer abutments against the corresponding inner abutments, and the overlapping faces of the shield can be positioned flush within the shield due to ridges and jogs formed on the shield, the distance of the ridges or jogs being equal to the width of the shield wall. In the absence of tissue pressure on the shield, the shield, in its collapsed configuration with its surfaces abutting each other, does not remain in its collapsed and locked configuration because it is molded and biased toward its larger, resting configuration. Therefore, the lock is a one-piece lock that requires tissue pressure to achieve the locked configuration in one form. Tissue pressure at the incision / mouth location cooperates to collapse and maintain the abutment surfaces in the locked configuration. In use, the shield is first collapsed from its resting configuration by closing the gap and collapsing the first end of the band into an overlapping configuration with at least a portion of the second end of the band. To increase the overlap, the band is curled downward to further reduce the inner diameter to a size that fits within the incision / mouth. The shield is inserted into the incision / mouth, released within the incision / mouth, and subjected to pressure from surrounding tissue resulting from a smaller incision / mouth diameter than the shield's collapsed configuration or from increasing the shield's size by extending the shield from its collapsed configuration. The shield is curled back in the opposite direction to increase the shield's inner diameter. Increasing the inner diameter tends to retract tissue at the edges of the incision / mouth. Tissue retraction increases the biasing force of the tissue back onto the shield. Reducing the amount of shield overlap ratchets the abutments into successive locked positions in which one or more abutments are in contact with each other or with an edge or ridge. Contact with the abutments prevents the shield from collapsing and secures the inner diameter. When viewed from above along the longitudinal axis of the shield, the shield will assume a helical shape in a plane perpendicular to the longitudinal axis when it is in the collapsed configuration, and when in the rest configuration, the shield will in one form form an open circle or an open oval.In another configuration, the first end of the shield slightly overlaps the second end of the shield. A locking mechanism, in cooperation with tissue pressure, helps secure the shield within the incision / mouth. The bold C-shaped curvature of the outer surface is not necessary to help secure the shield within the incision / mouth due to the lock. Without the lock, forcing the lower flange of the bold C-shaped outer surface into the incision / mouth and resting the upper flange against the tissue surface helps secure the shield to the patient. The locking mechanism advantageously maximizes the working channel and inner diameter, which in this case are reduced to the sidewalls of the band by the bold C-shaped curvature. In one configuration, the shield has no or only a very slight curved profile to maximize the inner diameter, as it relies heavily on the locking mechanism to secure the shield to the patient. The outward jog at the second end of the band further maximizes the inner diameter where one portion of the band overlaps another portion of the band, resulting in a uniform and consistent inner diameter rather than a decrease at the overlap location. In one configuration, the shield does not have an outer abutment, but instead has a receiving area sized and shaped to receive the inner abutment when the shield spirals and overlaps the inner abutment. The receiving area prevents the overlapping band from bending inward toward the central lumen. Instead, the inner abutment is received within the receiving area to maximize the inner diameter and create a flush arrangement of the band around the inner circumference even where the overlapping portion of the band is present. In the most contracted configuration, in which the shield has the smallest inner diameter, the first end contacts the inner ridge, and all of the inner abutments are either received within the receiving area or in contact with the corresponding outer abutment.

[0167] Referring now to FIG. 168, another shield 5000 is shown to illustrate another locking mechanism of the present invention, with like reference numerals used to refer to like parts throughout. The first end 5010 has a protrusion 5034 sized and shaped to fit within a slot 5036 formed in the second end 5012. Abutment of the protrusion 5034 against the slot 5036 creates a locking configuration and prevents further reduction in the inner diameter. As can be seen in FIG. 168, the slot 5036 is oriented substantially vertically, and the slot 5036 is curved to match the curvature of the shield band. While one slot 5036 is shown, multiple slots 5036 can be provided to provide variability in the locking diameter.

[0168] 169 and 170, another form of locking shield 5000 is shown. The shield 5000 has a first end 5010 configured to slide into a slot 5036 formed at the second end 5012. A plurality of slots 5036 are provided to provide for variable locking diameters. Each slot 5036 is substan...

Claims

1. 1. A system for removing a tissue specimen through a body orifice defining a tissue margin, the system comprising: a shield having a band made of a soft, cut-resistant material, the band having inner and outer surfaces connected to one another by top and bottom ends and first and second ends, the band configured to define a central lumen with a longitudinal axis, the central lumen having a lumen diameter perpendicular to the longitudinal axis, the band being divided such that the band can move to a contracted configuration in which at least a portion of the outer surface at the first end overlaps the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, the band being configured to have a variable lumen diameter by varying the overlapping portion; a locking mechanism configured to fix the lumen diameter, the locking mechanism including at least one inner abutment formed on the inner surface, the inner abutment extending along at least a portion of the band along the longitudinal axis between the top end and the bottom end, the first end configured to contact the inner abutment to prevent reduction of the inner diameter in a locked configuration.

2. 1. A system for removing a tissue specimen through a body orifice defining a tissue margin, the system comprising: a shield having a band made of a soft, cut-resistant material, the band having inner and outer surfaces connected to one another by top and bottom ends and first and second ends, the band configured to define a central lumen with a longitudinal axis, the central lumen having a lumen diameter perpendicular to the longitudinal axis, the band being divided such that the band can move to a contracted configuration in which at least a portion of the outer surface at the first end overlaps the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, the band being configured to have a variable lumen diameter by varying the overlapping portion; a locking mechanism configured to fix the lumen diameter, the locking mechanism including at least one inner abutment formed on the inner surface and at least one outer abutment formed on the outer surface, the inner abutment and the outer abutment extending along at least a portion of the band along the longitudinal axis between the top end and the bottom end, the at least one inner abutment configured to contact the at least one outer abutment to prevent reduction of the inner diameter in a locked configuration.

3. 1. A system for removing a tissue specimen through a body orifice defining a tissue margin, the system comprising: a shield having a band made of a soft, cut-resistant material, the band having inner and outer surfaces connected to one another by top and bottom ends and first and second ends, the band configured to define a central lumen with a longitudinal axis, the central lumen having a lumen diameter perpendicular to the longitudinal axis, the band being divided such that the band can move to a contracted configuration in which at least a portion of the outer surface at the first end overlaps the inner surface at the second end and forms a spiral in juxtaposition with the inner surface, the band being configured to have a variable lumen diameter by varying the overlapping portion; a locking mechanism configured to fix the lumen diameter, the locking mechanism including at least one inner abutment formed within the inner surface, the at least one inner abutment configured to contact one of the first end or at least one outer abutment formed within the outer surface to define a locked configuration having a locked lumen diameter.

4. A system according to any one of claims 1 to 3, wherein in the locked configuration, the first ends simultaneously contact one of the other inner abutments.

5. 5. The system of claim 1, wherein at least one inner abutment is configured to contact the first end and at least one other inner abutment is configured to contact the outer abutment.

6. 6. The system of claim 1, wherein the band has a plurality of inner abutments spaced around the circumference of the inner surface, and the outer surface has a plurality of receiving areas, each receiving area extending toward the longitudinal axis and sized and shaped to receive an inner abutment when in the contracted configuration.

7. 7. The system of claim 1, wherein each receiving area has an outer abutment configured to contact an inner abutment received within the receiving area to prevent reduction of the inner diameter.

8. 8. The system of claim 1, wherein the inner surface of the band has a slope at each receiving area interconnected with an inner abutment, the slope narrowing with increasing distance from the inner abutment and the second end.

9. 9. The system of claim 1, wherein each inner abutment is disposed about the inner surface such that, when in the contracted configuration, each inner abutment is received within a correspondingly disposed receiving area.

10. A system according to any one of claims 1 to 9, wherein each inner abutment is formed at the location of a receiving area.

11. 11. The system of claim 1, wherein one of the inner abutments is a ridge formed by curving a portion of the band outward to have a larger diameter, the ridge being configured to contact the first end of the band in a locked configuration.

12. The system of any one of claims 1 to 11, wherein the inner abutment is disposed between the raised portion and the second end.

13. The system of any one of claims 1 to 12, wherein the inner abutment extends perpendicularly from the inner surface.

14. A system according to any one of the preceding claims, wherein the height of the inner abutment is substantially equal to the thickness of the band between the inner and outer surfaces.

15. The system of any one of claims 1 to 14, wherein the outer abutment extends perpendicularly from the outer surface.

16. The system of any one of claims 1 to 15, wherein the height of the outer abutment is substantially equal to the thickness of the band between the inner and outer surfaces.

17. 17. A system as described in any one of claims 1 to 16, wherein the inner abutments are spaced around the circumference of the band to provide multiple releasable locking positions for variably fixing the inner diameter.

18. The system of any one of claims 1 to 17, wherein the bands have a rest configuration in which there is no overlap.

19. 19. The system of any one of claims 1 to 18, wherein the first end has a marker that indicates to a user whether the first end or the second end of the band is located inward toward the longitudinal axis.

20. The system of any one of claims 1 to 19, wherein the inner surface has three inner abutments and the outer surface has three corresponding receiving areas.

21. The system of any one of claims 1 to 20, wherein the inner surface has three inner abutments and the outer surface has three outer abutments.

22. 22. The system of any one of claims 1 to 21, wherein in the contracted configuration, at least a portion of the outer surface of the band overlaps and faces at least a portion of the inner surface of the band such that the inner surface of the portion of the band fits within the outer surface of the band.

23. 23. The system of any one of claims 1 to 22, wherein the contour of the outer surface from the top end to the bottom end is C-shaped around its periphery.

24. 24. The system of any one of claims 1 to 23, further comprising a containment bag, the shield being positioned within the containment bag to protect at least a portion of the containment bag from surgical morcellation.

25. The system of any one of claims 1 to 24, wherein when in the locked configuration, expansion and contraction of the inner diameter is prevented.

26. 26. The system of claim 1, wherein the outer surface of the band has a recess disposed along the longitudinal axis from the top end to the bottom end and extending circumferentially around the guard from the first end to the second end.

27. 27. The system of any one of claims 1 to 26, wherein the apex end has a top flange extending radially outward to form a funnel-like shape with the lumen diameter increasing toward the apex end, and the bottom end has a bottom flange extending radially outward to form a funnel-like shape with the lumen diameter increasing toward the bottom end.

28. The system of any one of claims 1 to 27, wherein the shield has two or more locking configurations, each locking configuration having a different locked state lumen diameter.

29. 29. The system of any one of claims 1 to 28, wherein the locking mechanism operates in conjunction with tissue pressure to achieve a locked configuration upon insertion into the body opening.

30. The system of any one of claims 1 to 29, wherein when in the locked configuration, the shield retracts the tissue margins upon insertion into the body opening.

31. The system of any one of claims 1 to 30, wherein the locked configuration prevents reduction of lumen diameter in the locked state.

32. 32. The system of any one of claims 1 to 31, wherein the shield remains in a locked configuration only when disposed within the body opening and subjected to circumferential pressure exerted on the shield by the tissue margin.

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