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.SOLUTION: One system includes a cut-resistant tissue guard removably insertable into a containment bag. The tissue specimen is isolated and contained within the containment bag while the guard protects the containment bag and surrounding tissue from incidental contact with a sharp instrument during morcellation and extraction of the tissue specimen. The guard is adjustable for easy insertion and removal and configured to securely anchor in 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 182

Description

[Technical field]

[0001] The present invention relates to medical devices, and more particularly to systems and methods for the removal of tissue through a body orifice.

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 281,820, entitled "Systems and methods for tissue removal," filed Jan. 22, 2016, which is incorporated by reference in its entirety. [Background technology]

[0003] Systems and methods are described for surgical tissue removal through a body opening, including a small incision site and / or a body orifice. Where necessary, a small incision is made in the patient to access a surgical target tissue located within a body cavity. In some cases, the surgical target tissue is approached through the body orifice without an initial incision. Sometimes, the target tissue is approached directly through the incision or body orifice. In other cases, an access device system is placed and / or positioned into, across, at, and / or within the incision and / or body orifice to retract tissue and enlarge, modify, and / or isolate the incision or body orifice. The access device system serves as a portal to access the target tissue located within or adjacent to the body cavity or body orifice. The target tissue is dissected from adjacent and surrounding tissue using known surgical procedures and techniques. Once freed, the target tissue is ready to be removed through the small incision or body orifice. If the target tissue is too large to remove in its entirety, it is reduced in size and removed in pieces through small incisions. Ideally, the surgeon will "core" or "peel" the target tissue to keep it in one piece as much as possible. However, more often than not, the target tissue is subdivided into multiple pieces.

[0004] Reducing the size of the target tissue is called morcellation. The morcellation procedure involves cutting the target tissue into smaller pieces, for example with a scalpel or knife, or using a powered morcellator, so that it can be removed through a small incision. The pieces of target tissue are removed from the patient through the small incision. When reducing the size of the target tissue to pass through the small incision, small pieces of tissue may break off and be left inside the patient. Therefore, morcellation is contraindicated in cases of malignant tumors or endometriosis. If a cancer is morcellated, it may spread the malignant tissue, upstaging the cancer and increasing the patient's mortality.

[0005] Hysterectomy is an example of a surgical procedure that may involve morcellation. Over 500,000 hysterectomies are performed annually on women in the United States. Common reasons women may undergo hysterectomies are the presence of uterine fibroids, cancer, endometriosis, or uterine prolapse. Of these hysterectomies, approximately 200,000 are performed laparoscopically. If the uterus is too large (>300g) to be removed through the vagina, or if the cervix is ​​still in place, the specimen must be reduced in size so that it can be removed through an abdominal incision or vagina. During myomectomy (removal of uterine fibroids), large uterine fibroids may also need to be removed using a morcellation technique. During morcellation, the target tissue (usually the uterus, but sometimes adnexal structures) is moved to the abdominal wall surface, such as by a tissue grasper, reduced in size with a blade, and removed from the pelvic cavity through an incision. In another variation, the target tissue is removed through a body orifice, such as through the vagina. Uterine fibroids, or uterine leiomyomas, account for approximately 30-40% of hysterectomies. These are benign tumors of the uterus that can result in heavy and painful bleeding. Previously, there was little concern that these tumors could be undetected cancer, or leiomyosarcoma, and it was thought to affect approximately 1 in 10,000 women. More recent data has emerged supporting that the risk of undetected malignancy in these tumors is much higher, estimated to range from 1:1000 to 1:400. Due to this elevated risk, many surgeons have begun to modify their techniques to contain the specimen, and instead of morcellating without a bag in a procedure called open morcellation, they are performing a closed morcellation process in which the prolapsed pieces are contained by morcellating in a bag to prevent the dispersion and seeding of tumor cells. Many GYN societies, including the AAGL, ACOG, and SGO, have issued statements warning of the potential dangers of open morcellation. On April 17, 2014, the FDA issued a statement discouraging the use of open power morcellation for women undergoing hysterectomy and myomectomy for uterine fibroids.The FDA has also raised its estimate of the 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 describes such safe systems and methods for both manual and powered morcellation performed within a closed system. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] US Patent Application Publication No. 2011 / 0054260 Summary of the Invention

[0007] According to one aspect of the present invention, a surgical shield for insertion into and protection of an orifice of a patient is provided. The surgical shield includes a guard portion formed of a cut-resistant material in a generally tubular shape. The guard portion has an inner surface and an outer surface defining a thickness therebetween. A lumen extends along a longitudinal axis between a proximal opening at a proximal end of the shield and a distal opening at a distal end of the shield. The shield further includes a batten having a reinforcing portion connected to a handle portion. The reinforcing portion is connected to the guard portion and extends along the longitudinal axis of the guard portion. The handle portion is located at a proximal end of the guard portion and extends away from the proximal end of the guard portion to facilitate insertion of the shield.

[0008] According to another aspect of the present invention, a surgical shield for insertion into and protection of an orifice of a patient is provided. The surgical shield includes a guard portion having an expanded state and a contracted state. The guard portion is made of a cut-resistant, flexible material biased to return to the expanded state when deformed. The guard portion is generally tubular in shape and defines a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end. The guard portion has a transverse axis perpendicular to the longitudinal axis. The distal opening lies in a distal plane angled to the longitudinal axis to form a distal insertion wedge at the distal end to facilitate insertion of the shield into the orifice of the patient.

[0009] According to another aspect of the invention, a method is provided. The method includes providing a shield having a guard portion having an expanded state and a contracted state. The guard portion is made of a flexible material biased to return to the expanded state. The guard portion is generally tubular in shape and defines a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end. The method includes disposing the guard portion in the contracted state, inserting the shield into an orifice of a patient while in the contracted state, and releasing the shield from the contracted state such that it expands toward the expanded state and abuts the orifice.

[0010] According to another aspect of the invention, a method is provided. The method includes the steps of providing a shield having a guard portion made of a flexible cut-resistant material. The guard portion is generally tubular in shape and defines a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end. The shield includes a batten removably connected to the guard portion. The batten is relatively stiffer than the guard portion. The batten has a reinforcing portion connected to a handle portion. The reinforcing portion is connected to the guard portion so as to extend along the longitudinal axis of the guard portion. The handle portion is located at a proximal end of the guard portion and extends away from the proximal end of the guard portion. The method includes the steps of connecting the batten to the guard portion and inserting the shield into an orifice of a patient while the batten is connected to the guard portion. [Brief description of the drawings]

[0011] [Figure 1] 1 is a cross-sectional view of a containment bag and a guard disposed in an opening in a body wall according to the present invention. [Diagram 2] FIG. 2 is a top perspective view of a guard according to the present invention; [Diagram 3] FIG. 2 is a side view of a guard according to the present invention. [Figure 4] FIG. 2 is an end view of a guard according to the present invention. [Diagram 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. 2 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. 2 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. 2 is a top perspective view of a cap according to the present invention. [Figure 12] 1 is a side cross-sectional view of a cap and guard according to the present invention; [Figure 13] FIG. 2 is a side view of a cap and guard according to the present invention. [Figure 14] FIG. 2 is a top perspective view of a cap and guard according to the present invention. [Figure 15] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 16] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 17] 1 is a side cross-sectional view of a guard according to the present invention; [Figure 18] FIG. 1 is a top perspective view of a retractor according to the present invention. [Figure 19] FIG. 1 is a top perspective view of a retractor according to the present invention. [Figure 20A] FIG. 2 is a top perspective view of a storage bag and retractor combination according to the present invention; [Figure 20B] FIG. 2 is a side cross-sectional view of a tissue specimen, a body wall, and a containment bag with two rings according to the present invention. [Figure 21] FIG. 2 is a top perspective view of an expanded storage bag according to the present invention. [Figure 22] FIG. 2 is a top perspective view of a partially collapsed storage bag according to the present invention. [Figure 23] FIG. 2 is a top perspective view of a storage bag in a twisted state according to the present invention; [Figure 24] FIG. 2 is a plan view of a storage bag according to the present invention in a twisted state. [Figure 25A] FIG. 2 is a top perspective view of an exploded two-piece guard according to the present invention; [Figure 25B] FIG. 2 is a top perspective view of an assembled two-piece guard according to the present invention; [Figure 26] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 27] FIG. 2 is a top perspective view of a retractor ring and guard according to the present invention. [Figure 28] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 29] FIG. 2 is a partial cross-sectional view of a retractor ring and guard according to the present invention. [Diagram 30] FIG. 1 is a top perspective view of a balloon trocar according to the present invention with a removable seal housing. [Diagram 31] 1 is a side cross-sectional view of a balloon trocar according to the present invention. [Diagram 32] FIG. 2 is a side view of a stabilizer according to the present invention. [Diagram 33] FIG. 2 is a bottom view of the stabilizer according to the present invention. [Diagram 34] FIG. 34 is a cross-sectional view of the stabilizer according to the present invention taken along line 34-34 in FIG. [Diagram 35] FIG. 2 is a side view of a mortar stabilizer according to the present invention. [Diagram 36] FIG. 1 is a cross-sectional plan view of a mortar stabilizer in a locked configuration in accordance with the present invention. [Figure 37A] FIG. 2 is a plan view of a stabilizer in an unlocked configuration according to the present invention. [Figure 37B] FIG. 1 is a cross-sectional plan view of a morcellator stabilizer in an unlocked configuration in accordance with the present invention. [Figure 38] FIG. 2 is a top perspective view of a storage bag placed in a body opening according to the present invention. [Figure 39] FIG. 1 is a top perspective view of a containment bag disposed in a body opening and a morcellator stabilizer connected to the containment bag in an unlocked configuration in accordance with the present invention. [Diagram 40]FIG. 1 is a top perspective view of a morcellator having a protective obturator connected to a stability cap in accordance with the present invention. [Diagram 41] FIG. 1 is a bottom perspective view of a morcellator having a protective obturator connected to a stability cap in accordance with the present invention. [Diagram 42] FIG. 2 is a top perspective view of a morcellator connected to a stability cap in accordance with the present invention. [Diagram 43] FIG. 2 is a top perspective view of a stability cap according to the present invention. [Diagram 44] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Diagram 45] 1 is a side cross-sectional view of a tissue specimen within a containment bag placed across a body wall in accordance with the present invention. [Diagram 46] FIG. 2 is a side view of a storage bag deployment device according to the present invention. [Figure 47] FIG. 2 is a side view of a storage bag and deployment cap according to the present invention. [Figure 48] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 49] 1 is a side cross-sectional view of a tissue specimen within a containment bag placed across a body wall in accordance with the present invention. [Figure 50] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 50A] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 50B] FIG. 2 is a plan view of a storage bag according to the present invention. [Figure 50C] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 50D] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 50E] 1 is a plan view of a storage bag pattern according to the present invention, in which solid lines indicate valley folds and dashed lines indicate mountain folds. [Figure 50F] FIG. 2 is a partial plan view of a dimensioned pattern of a storage bag according to the present invention. [Figure 50G] 1 is a plan view of a storage bag pattern that is substantially square when viewed from above, in accordance with the present invention; FIG. [Figure 50H] FIG. 2 is a plan view of a storage bag having a triangular open end in accordance with the present invention. [Figure 51] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 52] FIG. 2 is a top perspective view of a guard inside a mold according to the present invention. [Diagram 53] FIG. 2 is a top perspective view of a guard on a mold according to the present invention. [Figure 54] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 55A] FIG. 2 is a side view of a ring of a storage bag according to the present invention. [Figure 55B] 55B is a cross-sectional view of a ring of a storage bag according to the present invention taken along line 55B-55B of FIG. 55A. [Figure 56A] FIG. 2 is a top perspective view of a semi-rigid rod before being formed into a ring of a storage bag according to the present invention. [Figure 56B] FIG. 2 is a top perspective view of a ring of the storage bag according to the present invention. [Figure 57A] FIG. 2 is a plan view of a side wall of a storage bag according to the present invention. [Figure 57B] FIG. 2 is a side view of a side wall of a storage bag according to the present invention. [Figure 58A] FIG. 2 is a side view of a storage bag according to the present invention. [Figure 58B] FIG. 58B is a cross-sectional view of a storage bag according to the present invention taken along section 58B of FIG. 58A. [Figure 59A] FIG. 2 is a side view of a storage bag according to the present invention. [Figure 59B] FIG. 2 is a top perspective view of a storage bag according to the present invention; [Figure 60] FIG. 1 is a top perspective view of a bag introducer according to the present invention. [Figure 61] FIG. 1 is a top perspective view of a bag introducer according to the present invention. [Figure 62] FIG. 1 is a top perspective view of a storage bag and bag introducer according to the present invention. [Figure 63] FIG. 1 is a top perspective view of a storage bag and bag introducer according to the present invention. [Figure 64] FIG. 2 is a top perspective view of a guard and bag introducer according to the present invention; [Figure 65] 1 is a side cross-sectional view of a tissue specimen within a containment bag and a guard positioned across a body wall in accordance with the present invention. [Figure 66] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 67] FIG. 2 is a side view of two side wall components of a guard according to the present invention. [Figure 68] FIG. 2 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] FIG. 1 is a side view of a body opening according to the present invention. [Figure 71A] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 71B] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 72] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 73] FIG. 2 is a semi-transparent side view of a guard according to the present invention. [Figure 74] FIG. 2 is a semi-transparent 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. 2 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. [Fig. 78A] FIG. 2 is a semi-transparent bottom view of a guard according to the present invention. [Fig. 78B] FIG. 2 is a semi-transparent plan view of a guard according to the present invention. [Fig. 78C] FIG. 78C is a cross-sectional view of the guard according to the present invention taken along line 78C-78C of FIG. 78B. [Figure 79] FIG. 2 is a semi-transparent top perspective view of a guard according to the present invention; [Figure 80] FIG. 2 is a plan view of a guard according to the present invention. [Figure 81]FIG. 2 is a plan view of a guard according to the present invention. [Figure 82] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 83] FIG. 2 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. 2 is a top perspective view of a guard according to the present invention; [Figure 86] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 87] FIG. 2 is a side view of a morcellator and guard according to the present invention. [Figure 88] FIG. 2 is a side cross-sectional view of a morcellator and guard according to the present invention. [Figure 89] FIG. 2 is a bottom perspective view of a 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. 2 is a top perspective view of a guard according to the present invention; [Figure 92] FIG. 2 is a semi-transparent top perspective view of a guard according to the present invention; [Figure 93] FIG. 2 is a side view of a guard according to the present invention. [Figure 94] FIG. 2 is a semi-transparent side view of a guard according to the present invention. [Figure 95] FIG. 2 is a plan view of a guard according to the present invention. [Figure 96] FIG. 2 is a semi-transparent 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] FIG. 2 is a semi-transparent cross-sectional plan view of a guard according to the present invention. [Figure 99] FIG. 2 is a semi-transparent side view of a retractor and guard according to the present invention. [Figure 100] 1 is a side cross-sectional view of a retractor and guard according to the present invention. [Figure 101] FIG. 2 is a cross-sectional top perspective view of a retractor and guard according to the present invention. [Figure 102]FIG. 2 is a cross-sectional top perspective view of a retractor and guard according to the present invention. [Figure 103] FIG. 2 is a semi-transparent top 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. 2 is a plan view of a guard according to the present invention. [Figure 106] FIG. 2 is a top perspective view of a retractor and guard according to the present invention. [Figure 107] FIG. 2 is a top view of a retractor and guard according to the present invention. [Figure 108] FIG. 2 is a bottom perspective view of a guard according to the present invention; [Figure 109A] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 109B] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 109C] FIG. 2 is a bottom perspective view of a guard according to the present invention; [Fig. 109D] FIG. 2 is a plan view of a guard according to the present invention. [Figure 109E] FIG. 2 is a top perspective view of a guard according to the present invention; [Fig. 109F] FIG. 2 is a bottom perspective view of a guard according to the present invention; [Figure 109G] FIG. 2 is a plan view of a guard according to the present invention. [Figure 110] FIG. 2 is a top perspective view of a guard according to the present invention; [Figure 111] FIG. 2 is a top perspective view of a two-piece guard according to the present invention; [Figure 112] FIG. 2 is a top perspective view of a blade guard according to the present invention; [Figure 113] FIG. 2 is a cross-sectional top perspective view of a blade guard according to the present invention; [Fig. 114] 2 is a cross-sectional view of a blade receiver of the blade guard according to the present invention; [Figure 115] FIG. 2 is a bottom perspective view of a blade according to the present invention. [Fig. 116] FIG. 2 is a top perspective view of a blade according to the present invention; [Fig. 117]FIG. 2 is an exploded top perspective view of a blade guard assembly according to the present invention; [Fig. 118] FIG. 2 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; [Figure 120] FIG. 2 is an exploded top perspective view of a blade guard assembly according to the present invention; [Figure 121] FIG. 2 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; [Figure 123] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; [Figure 124] FIG. 2 is a bottom view of a blade guard assembly according to the present invention. [Fig. 125] 1 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; [Fig. 126] FIG. 2 is a bottom perspective view of a blade guard assembly according to the present invention; [Figure 127] FIG. 2 is a side view of a storage 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 side cross-sectional view of a handle of a tissue grasper according to the present invention. [Fig. 130] 1 is a side cross-sectional view of a distal end of a tissue grasper according to the present invention. [Fig. 131] FIG. 2 is a cross-sectional top perspective view of a distal end of a tissue grasper according to the present invention. [Fig. 132] 1 is a side cross-sectional view of a distal end of a tissue grasper according to the present invention. [Fig. 133] FIG. 1 is a top perspective view of a morcellator according to the present invention. [Fig. 134] FIG. 2 is a bottom perspective view of a morcellator according to the present invention. [Fig. 135A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 135B]FIG. 2 is a plan view of a storage bag in a roll-up configuration according to the present invention. [Fig. 135C] FIG. 2 is an end view of a storage bag in a roll-up configuration according to the present invention. [Fig. 135D] FIG. 2 is an end view of a storage bag according to the present invention. [Fig. 136A] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 136B] 1 is a side cross-sectional view of a body wall, a tissue specimen within a containment bag, and a tissue guard according to the present invention. [Fig. 137A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 137B] FIG. 2 is a top view of an open storage bag according to the present invention. [Fig. 137C] 1 is a cross-sectional view of a ring of a storage bag according to the present invention. [Fig. 138A] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 138B] 1 is a side cross-sectional view of a body wall, a tissue specimen within a containment bag, and a tissue guard according to the present invention. [Fig. 138C] 1 is a side cross-sectional view of a body wall, a tissue specimen within a containment bag rolled up around a bag ring, and a tissue guard according to the present invention. [Fig. 139A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 139B] FIG. 2 is a top view of an open storage bag according to the present invention. [Figure 139C] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 140A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 140B] FIG. 2 is a plan view of a storage bag according to the present invention. [Fig. 141A] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 141B] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 141C]1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 141D] 1 is a side cross-sectional view of a body wall, a tissue specimen within a containment bag, and a tissue guard according to the present invention. [Fig. 142A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 142B] 142B is a cross-sectional view of a storage bag according to the present invention taken along line 142B-142B of FIG. 142A. [Fig. 142C] 1 is a cross-sectional view of an inflated storage bag according to the present invention. [Fig. 143A] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 143B] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 143C] 1 is a side cross-sectional view of a tissue specimen within a body wall and a containment bag in accordance with the present invention. [Fig. 143D] 1 is a side cross-sectional view of a body wall, a tissue specimen within an inflated containment bag, and a tissue guard according to the present invention. [Fig. 144A] FIG. 2 is a side view of a storage bag according to the present invention. [Fig. 144B] 144B is a cross-sectional view of a storage bag according to the present invention taken along line 144B-144B of FIG. 144A. [Fig. 144C] 1 is a cross-sectional view of an inflated storage bag according to the present invention. [Fig. 145A] 1 is a side cross-sectional view of a body wall and a tissue specimen within a containment bag according to the present invention. [Fig. 145B] 1 is a side cross-sectional view of a tissue specimen within a body wall and an inflated containment bag in accordance with the present invention. [Fig. 145C] 1 is a side cross-sectional view of a tissue specimen within a body wall and an upwardly extended, inflated containment bag in accordance with the present invention; [Fig. 145D] 1 is a side cross-sectional view of a body wall, a tissue specimen within an inflated containment bag, and a tissue guard according to the present invention. [Fig. 146A] FIG. 2 is a side view of a guard according to the present invention. [Fig. 146B] FIG. 2 is a plan view of a bottom view of a guard according to the present invention. [Fig. 147A] FIG. 2 is a plan view of a guard according to the present invention. [Fig. 147B] FIG. 2 is a side view of a guard according to the present invention. [Fig. 148A] FIG. 2 is a side view of a guard according to the present invention. [Fig. 148B] FIG. 2 is a plan view of a guard according to the present invention. [Figure 149] FIG. 1 is a top perspective view of a morcellation and bag system according to the present invention. [Fig. 150A] FIG. 1 is a top perspective view of a powered morcellator according to the present invention; [Fig. 150B] FIG. 2 is a top perspective cross-sectional view of a powered morcellator according to the present invention. [Fig. 150C] FIG. 2 is a cross-sectional view of a powered morcellator according to the present invention. [Fig. 150D] FIG. 2 is a cross-sectional view of a powered morcellator according to the present invention. [Fig. 151] FIG. 2 is a top perspective view of a specimen receptacle according to the present invention. [Fig. 152] FIG. 2 is a top perspective cross-sectional view of a bag tube and bag according to the present invention. [Fig. 153A] FIG. 2 is a top perspective cross-sectional view of a storage bag in an open configuration according to the present invention. [Fig. 153B] FIG. 2 is a top perspective cross-sectional view of a storage bag in a closed configuration according to the present invention. [Fig. 154A] FIG. 2 is a top perspective cross-sectional view of a storage bag in an open configuration according to the present invention. [Fig. 154B] FIG. 2 is a top perspective cross-sectional view of a storage bag in a closed configuration according to the present invention. [Fig. 155A] FIG. 2 is a top perspective cross-sectional view of a storage bag in an open configuration according to the present invention. [Fig. 155B] FIG. 2 is a top perspective cross-sectional view of a grasper and storage bag in an open configuration in accordance with the present invention. [Fig. 155C] FIG. 2 is a top perspective cross-sectional view of a storage bag rolled around a grasper according to the present invention. [Fig. 156A] FIG. 2 is a top perspective cross-sectional view of a storage bag in an open configuration according to the present invention. [Fig. 156B] FIG. 2 is a top perspective cross-sectional view of a storage bag in a closed configuration according to the present invention. [Fig. 157A] FIG. 2 is a top perspective cross-sectional view of a storage bag in an open configuration according to the present invention. [Fig. 157B] FIG. 2 is a top perspective cross-sectional view of a storage bag in a closed configuration according to the present invention. [Fig. 158A] FIG. 2 is a plan view of a guard according to the present invention. [Fig. 158B] FIG. 1 is a side view of a guard attached to a morcellator shaft in accordance with the present invention. [Fig. 158C] FIG. 1 is a top view of a guard attached to a morcellator shaft in accordance with the present invention. [Fig. 158D] FIG. 1 is a side cross-sectional 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. [Fig. 158F] FIG. 1 is a side cross-sectional view of a guard attached to a morcellator shaft in accordance with the present invention. [Fig. 159] 1 is a top perspective cross-sectional view of a storage bag having a bag tube and a top opening in accordance with the present invention; [Fig. 160] 1 is a side cross-sectional view of a storage bag having a bag tube and a side opening according to the present invention. [Fig. 161] 1 is a side cross-sectional view of a storage bag having a bag tube and a side opening according to the present invention. [Fig. 162A] FIG. 2 is a side view of a tissue specimen within a storage bag according to the present invention. [Fig. 162B] FIG. 2 is a side cross-sectional view of a tissue specimen within a containment bag attached to a morcellator according to the present invention. [Fig. 162C] FIG. 2 is a plan view of a storage bag attached to a morcellator according to the present invention. [Fig. 163A] FIG. 2 is a side cross-sectional view of a containment bag and morcellator system according to the present invention. [Fig. 163B] 1 is a side cross-sectional view of a body wall, tissue specimen, containment bag, and morcellator system according to the present invention. [Fig. 163C] 1 is a side cross-sectional view of a body wall, a tissue specimen within a containment bag, and a morcellator system according to the present invention. [Fig. 164] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 165] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 166] FIG. 2 is a plan view of a shield according to the present invention. [Fig. 167] FIG. 2 is a partial cross-sectional plan view of a shield of a locking arrangement according to the present invention. [Fig. 168] FIG. 2 is a bottom perspective view of a shield according to the present invention. [Fig. 169] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 170] FIG. 2 is a plan view of a shield according to the present invention. [Fig. 171] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 172] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 173] FIG. 2 is a partial plan view of a shield according to the present invention. [Fig. 174] FIG. 2 is a partial cross-sectional plan view of a shield according to the present invention. [Fig. 175] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 176] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 177] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 178] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 179] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 180] FIG. 2 is a partial top perspective view of a shield according to the present invention; [Fig. 181] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 182] FIG. 2 is a front perspective view of a shield according to the present invention. [Fig. 183] FIG. 2 is a rear perspective view of a shield according to the present invention. [Fig. 184] FIG. 2 is a top perspective view of a shield according to the present invention. [Fig. 185] FIG. 2 is a front view of a shield according to the present invention. [Fig. 186] FIG. 2 is a rear view of a shield according to the present invention. [Fig. 187A] FIG. 2 is a side cross-sectional view of a shield according to the present invention. [Fig. 187B] FIG. 2 is a side cross-sectional view of a shield according to the present invention with a batten at the bottom or rear end of the shield. [Fig. 187C] FIG. 2 is a top perspective view of a shield without battens according to the present invention. [Fig. 188] FIG. 2 is a side cross-sectional view of a shield according to the present invention. [Fig. 189A] 1 is a side cross-sectional view of a shield showing an insertion orientation in accordance with the present invention. [Fig. 189B] 1 is a side cross-sectional view of a shield showing an insertion orientation in accordance with the present invention. [Fig. 190A] 1 is a side cross-sectional view of a shield showing an undeformed, expanded configuration in accordance with the present invention. [Fig. 190B] 1 is a side cross-sectional view of a shield showing a modified reduced configuration in accordance with the present invention. [Fig. 190C] FIG. 2 is a side view of a user's finger inserted into the shield according to the present invention. [Fig. 190D] FIG. 2 is a side cross-sectional view of an introducer within a shield according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The following description is provided to enable those skilled in the art to make and use the surgical tools and methods described herein, and describes what the inventors believe to be the best mode for carrying out the invention. However, various modifications will still be apparent to those skilled in the art. These modifications are intended to be within the scope of the present disclosure. Different embodiments or aspects of such embodiments will be shown in various drawings and described throughout the specification. However, it should be noted that although shown or described separately, each embodiment and its aspects can be combined with one or more of the other embodiments and aspects, unless expressly indicated. Each combination is not explicitly described solely for ease of reading the specification.

[0013] Referring now to FIG. 1, a closed morcellation procedure according to the present invention is shown. A small incision is made at a location in a patient's abdominal wall 10 and the body cavity 12 is accessed through an opening 14 across the abdominal wall 10. Laparoscopic techniques and instruments such as trocars, laparoscopes, graspers and scalpels may be used to create a single site opening, scout the target tissue and dissect the target tissue from surrounding tissue structures. Additional incisions or access sites may be used to insert instruments and scopes to facilitate the procedure. After the target tissue 16, such as at least a portion of the uterus in a hysterectomy, is completely dissected, a specimen retrieval bag 18 is inserted through the opening 14 in the abdominal wall 10 and placed within the body cavity 12. The bag 18 may be delivered through a trocar or cannula placed across the abdominal wall 10. The bag 18 is deployed 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 bags 18 may be used. The bag 18 may be transparent so that the contents may be viewed from outside the bag 18 through a scope placed into the body cavity 12 through a secondary incision in the abdominal wall 10. The contents of the bag 18 may be illuminated from outside the bag 18. The location of the target tissue 16 may also be viewed through the transparent bag 18 to confirm the progress of the morcellation and the location and proximity of the target tissue 16 to the opening 14. The bag 18 may also be viewed through the secondary incision to verify the condition of the bag 18 to ensure that it is not tangled or twisted and that the specimen is moving towards the opening without dragging the bag 18 along with it (which may result in the bag accidentally contacting the blade and being cut). Opaque bags 18 may also be used. The material of the bag 18 is also important. Generally made of plastic, the bag is strong enough to withstand pulling and heavy traction, has sufficient extensibility, is relatively thin, flexible, and resilient to puncture and tearing. The bag is folded and reduced in size so that it can be inserted through a small incision / trocar approximately at least 5 mm in diameter.Also, when expanded, the bag is large enough to receive a large tissue piece and extend through opening 14 to the surface of abdominal wall 10, as shown in Figure 1, creating a large enough working space inside bag 18 for instruments, scope, morcellator 24, and scalpel 26. Bag 18 includes a tether or drawstring 22 that is configured to tighten to close the opening and to open bag 18. Bag 18 withstands insufflation pressure and does not leak. Various examples of bags for inclusion or incorporation into morcellation systems, where the entire system, part of the system, or combination of systems and / or components thereof are arranged to provide containment of an object to be morcellated according to various embodiments of the present invention, as well as devices for inserting, deploying, and / or removing the bags, are described in U.S. Patent Application Serial Nos. 08 / 540,795 (filed October 11, 1995); 11 / 549,701 (filed October 16, 2006); 11 / 549,971 (filed October 16, 2006); 12 / 902,055 (filed October 11, 2010); and 13 / 252,110 (filed October 3, 2011), the entire disclosures of which are incorporated herein by reference as if fully set forth. Additional bag variations are described in more detail hereinafter.

[0014] After the target tissue 16 is positioned inside the bag 18, the tether 22 is grasped by hand or by a laparoscopic grasper and at least a portion of the bag 18 is pulled through the abdominal wall opening 14. The tether 22 is pulled to close the bag opening 20. The initial incision can be made larger, approximately 15-40 mm, before the bag 18 is pulled through the opening 14. If the target tissue 16 is too large to pass through the opening 14, the target tissue 16 will sit inside the body cavity 12 below the abdominal wall 10. The remaining portion of the bag 18, including the opening 20 of the bag 18, is pulled through the abdominal wall opening 14 and extends through the opening 14 and along the upper surface of the abdominal wall 10 outside the patient, as shown in FIG. 1. The bag 18 can be rolled down and / or pulled taut across the surface of the abdominal wall 10 to maintain its position and provide some tissue retraction to the opening 14.

[0015] The guard 28 is inserted through the opening 20 of the bag 18. The guard 28 has a diameter within the incision / opening 14 such that the guard 28 is held in place when placed within the opening 14. The guard 28 can also retract tissue at the incision / opening and is therefore 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 includes an inner surface 30 and an outer surface 32 that define sidewalls interconnecting a top portion 34 and a bottom portion 36. The inner surface 30 defines a central lumen 38 that extends between the top portion 34 and the bottom portion 36. The inner surface 30 includes a curved funnel portion near the top portion 34, which may be convex or frusto-conical. The guard 28 includes a top circumferential flange 40 and a bottom circumferential flange 42 that extend radially outward to form surfaces for seating against the upper and lower surfaces, respectively, of the abdominal wall 10. The top flange 40 may include features such as holes for passing the tether 22 through which the guard 28 is secured to the bag 18. The guard 28 has an overall length of approximately 2.5 inches, although guards 28 of various lengths may be used depending on the thickness of the tissue wall 10 to be penetrated. Guards 28 having variable lengths, such as telescoping guards 28, are within the scope of the present invention. The inside diameter of the guard 28 at the mid-longitudinal portion is approximately 1.3 inches and can be as small as 0.6 inches. The outside diameter of the guard 28 at the mid-longitudinal portion is approximately 1.6 inches and conforms to the incision / opening such that the top circumferential flange 40 is held in place due to its larger diameter compared to the diameter of the guard 28 at the mid-longitudinal portion. The wall thickness at the mid-longitudinal section is approximately 0.16 inches and can be as thick as approximately 0.3 inches. The guard 28 is made of any polymer, such as KRATON® or polyethylene, although the guard can be made of any suitable material, including metal. The guard 28 can be flexible so that it can be compressed slightly for easy insertion through the opening 14 in the abdominal wall 10.The thickness of and / or the selection of materials for the guard 28 are selected so that the guard 28 can withstand cutting and puncturing forces from a blade, knife, scalpel, morcellator, etc. The guard 28 serves as a cutting board, i.e., a surface against which the target tissue is placed to be cut prior to removal. The target tissue 16 is grasped by the laparoscope 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 somewhere along the length of the guard 28. A blade, such as a scalpel or morcellator, is then moved to contact the portion of the target tissue to be cut within the position of the guard 28 and cut the target tissue portion. The cut target tissue portion is drawn through the opening 14 to a surface outside the patient, and a new portion of the target tissue to be cut and removed is brought into position along the guard 28. This process is repeated until the entire specimen has been removed from the bag 18, either whole or in portions. The guard 28 serves as a protection for the bag 18. The practitioner is free to cut the target tissue within the location of the guard 28, and even against the guard's inner surface 30, thereby reducing the risk of tearing the bag 18 with a scalpel or morcellator. The guard 28 not only protects the specimen retrieval bag 16 from accidental cutting, the guard 28 also protects the surrounding tissue, such as the abdominal wall, from accidental cutting. The guard 28 preserves the integrity of the bag 16, effectively maintaining a closed morcellation system. The surgeon is able to quickly and safely reduce the specimen and remove it from the abdominal cavity.

[0016] Once the guard 28 is in place, the surgeon grasps the specimen 16 and pulls it up 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 will "core" or "peele" the specimen 16 to keep it in one piece as much as possible. However, more often than not, the specimen 16 is subdivided into multiple pieces. While morcellating through the incision, the surgeon is able to maintain a pneumoperitoneum in the abdominal cavity 12 so that the progress of the morcellation can be viewed laparoscopically through a side port into the abdominal cavity 12 placed at the secondary site. The side port is located on the exterior of the bag 18 and allows the surgeon to see through the clear bag or to look at the bag itself to ensure it is maintaining its integrity. Once the specimen 16 has been morcellated, broken up, and reduced sufficiently to allow the remaining portions to be pulled through the incision, the guard 28 is removed and the bag 18 and its contents, including the pieces generated during morcellation, are withdrawn outside of the patient. The bag 18 maintains a closed system to prevent small pieces remaining from being left behind in the abdominal cavity 12, as opposed to a traditional morcellation where the surgeon must return and painstakingly search for and retrieve pieces scattered within the pelvic cavity to prevent potentially seeding new tumor sites. The surgeon may choose to give the patient a final laparoscopic view and then close the wound.

[0017] Although abdominal removal and morcellation have been described, the procedure can be performed similarly through the vaginal orifice if the cervix has been removed. The same process is followed to insert the bag 18 and place the specimen 16 laparoscopically into the bag 18. The tether 22 would be pulled through the vagina rather than through the abdominal wall opening 14. In a similar manner, the specimen 16 would rest at the fundus of the vagina while the bag 18 would be released through the vagina and outside the patient. The surgeon can roll down or pull taut the bag 18 to maintain its position and provide some retraction. The surgeon places a guard 28 transvaginally to protect the integrity of the bag 18 and maintain a closed system, grasp and bring out the specimen 16, and morcellate it to reduce the size of the specimen 16. Morcellation of the specimen is performed at and / or against the guard 28 to protect the bag and surrounding tissue from inadvertent dissection. The surgeon can maintain pneumoperitoneum and monitor the progress of the morcellation laparoscopically. Once the specimen 16 has been morcellated, disrupted, and reduced sufficiently to allow the remaining portions to be withdrawn through the vagina, the guard 28 is removed and the bag 18 and its contents, including the pieces generated during morcellation, are withdrawn outside of the patient. The bag 18 maintains a closed system to prevent small remaining pieces from being left behind in the abdominal cavity and to prevent harmful material, such as cancer cells, from being dispersed within the abdominal cavity, as opposed to a traditional morcellation in which the surgeon must return to painstakingly search for and retrieve pieces scattered within the pelvic cavity and explore the pieces within the pelvic cavity. The surgeon can choose to perform a final laparoscopic view of the patient and close the vaginal cuff and abdominal incision.

[0018] 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 includes a rigid ring 46 that is removably connectable to a proximal end of the guard 28. The cap 44 includes a lever 48 for locking the cap 44 to the guard 28. The cap 44 includes a penetrable portion 50, which may be made of a gel that is configured to seal against an instrument inserted therethrough and maintain a pneumoperitoneum within the abdominal cavity. FIGS. 12-13 show the cap 44 connected to the guard 28. An insufflation port 52 may be provided within the cap 44. The cap 44 may be snap-fit ​​onto the guard 28 and sealingly locked thereto with the lever lock 48 such that a pneumoperitoneum is maintained. FIG. 14 shows the cap 44 having multiple ports 54. Each port 54 is configured to receive a laparoscopic instrument and includes one or more internal seals for sealing against the inserted instrument. Multi-port cap 44 advantageously allows for the insertion of a grasper, laparoscope and / or morcellator through a single site.

[0019] 15-17 show another variation of the guard 28, which includes a balloon 56 at the distal end of the guard 28. The balloon 56 is shown in an inflated configuration in FIG. 15. In the inflated configuration, the balloon 56 extends radially outward to form a wide flange for fastening against the abdominal wall 10 within the abdominal cavity 12, making the guard 28 less likely to be inadvertently removed from the opening 14. FIG. 16 shows the balloon in a deflated configuration, at which the guard 28 is easily inserted into and removed from the opening 14. The guard 28 of FIGS. 15-17 can also be connected to the cap 44. The guard 28 can be made of any polymeric material, including polycarbonate or similar materials.

[0020] The funnel-shaped inlet at the proximal end of the guard 28 has been described above. In another variation, the funnel-shaped inlet can expand radially outward to provide a larger surface area against which tissue can be abutted and cut. The flared proximal end also helps to hold the bag in place outside the patient and between the guard 28 and the tissue margin 10. In another variation, the guard 28 includes a flared distal end that is a frusto-conical or curved shape. The flared distal end can include an enlarged, radially extending flange that spreads the bag 18 laterally inside the abdominal cavity. The flared distal end helps to keep the bag in an open position and keeps it clear of the specimen and away from the distal inlet of the guard 28, thereby protecting the bag 18 from inadvertent contact with the blade. In a variation of the flared distal end 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 longitudinal midsection. In a variation of the flared proximal end of guard 28, the proximal diameter of guard 28 at the proximal opening is larger than the diameter of guard 28 at the mid-longitudinal portion. In yet another variation, guard 28 includes a flared proximal end and a flared distal end, retaining both advantages discussed above.

[0021] A method for tissue removal using guard 28 in conjunction with cap 44 will now be described. After completion of a laparoscopic hysterectomy or other incision, the specimen 16 is fully dissected from surrounding tissue and awaits removal. The surgeon inserts specimen bag 18 (which may be transparent) into the pelvis and places specimen 16 into bag 18. The surgeon then grasps tether 22 of bag 20 with a laparoscopic grasper and pulls bag 18 through abdominal wall incision 14 where a trocar has been placed. If necessary, the surgeon extends the incision 15-25 mm before pulling the bag the full distance. Since specimen 16 is too large to pass through opening 14, specimen 16 will rest inside the pelvic cavity, just below abdominal wall 10, while the remainder of bag 18 is pulled out of the incision and opened outside the patient, as shown in FIG. 1. The surgeon can roll down or pull taut on the bag to maintain its position and provide some retraction. The surgeon then inserts guard 28 into the incision to protect bag 18 and abdominal wall 10 during morcellation and retract the incision. The integrity of the bag is preserved and a closed system is maintained.

[0022] The guard 28 is placed into the opening 20 of the bag 18 and positioned within the incision such that the guard 28 extends across the tissue margin 10. A cap 44 is connected to the guard 28. The cap 44 is snapped onto the proximal top flange 40 and a lever 48 of the cap 44 is moved to a locked position to seal the cap 44 onto the guard 28. The guard 28 may include a reinforcing wire 58 to maintain the shape and rigidity of the top flange 40. The wire 58 can be seen in Figures 1, 5-6, 10 and 12. With the cap 44 in place, the bag 18 can be insufflated. In one variation, only the bag 18 is insufflated relative to 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 such that the pressure inside the bag 18 is greater than the insufflation pressure of the abdominal cavity 12. Insufflation can occur through a trocar inserted through the cap 44 or through an insufflation port 52 in the cap 44. With the cap 44 in place, the powered morcellator 24 is inserted inside the bag 18 through the pierceable portion 50 of the cap 44. Alternatively, if a multi-port cap 44 is used, the morcellator 24 can be inserted through one of the ports 54. A surgical grasper is also inserted through the cap 44, either through the pierceable portion 50 or through one of the ports 54, to grasp and draw the target tissue 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 previously mentioned, the guard 28 protects the bag 18 from puncture, thereby assisting in maintaining a closed morcellation system. Powered morcellator 24 is positioned through gel cap 44 at a depth such that bladed distal end 60 of powered morcellator 24 is maintained within central lumen 38 and within the protected area or length of guard 28. Target tissue is drawn by the grasper toward blade 60 for morcellation and removal. The removed tissue travels through the central lumen of powered morcellator 24.

[0023] Instead of placing morcellator 24 through pierceable portion 50 of cap 44, a stabilizer is provided which acts in conjunction with bag 18 or guard 28 to hold morcellator 24 in place at a depth within a protected zone within central lumen 38 of guard 28. Maintaining the morcellator within lumen 38 of guard 28 prevents morcellator 24 from contacting the walls of bag 18 during the procedure, thereby preventing the bag from being inadvertently torn. Stabilizer variations are described further below.

[0024] After placing the morcellator 24 and cap 44, the surgeon may choose to insufflate the bag 18 and abdominal cavity 12. The surgeon may observe the position of the morcellator 24 and the target tissue 16, as well as the integrity of the bag 18 to ensure that the bag is not twisted or is not too close to the distal end 60 of the morcellator 24. Observation is performed via a laparoscope placed through a port 54 in the same incision site or through a secondary incision providing a lateral port. The specimen 16 is grasped by the tenaculum and pulled through the powered morcellator 24 to reduce its size. Ideally, the surgeon will "core" or "peele" the specimen to keep it in one piece as much as possible. However, more often than not, the specimen 16 is subdivided into multiple 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 bag 18 and its contents, including any pieces generated during morcellation, are withdrawn outside of the patient. The bag 18 maintains a closed system to prevent small remaining pieces from being left behind in the abdominal cavity 12, as opposed to a traditional morcellation in which the surgeon must return and painstakingly search for and retrieve pieces scattered throughout the pelvic cavity. The surgeon may choose to perform a final laparoscopic view of the patient and then close the wound.

[0025] Although abdominal removal and morcellation have been described, the powered morcellation procedure can be performed similarly through a body orifice such as the vagina. Following the same process, the bag 18 is inserted and the specimen 16 is placed laparoscopically within the bag 18. Rather than pulling the tether 22 through the abdominal wall opening 14, the tether 22 is pulled through the vagina. In a similar manner, the specimen 16 will seat at the fundus of the vagina while the bag 18 is opened through the vagina and outside the patient. The surgeon can roll down or taut the bag to maintain its position and provide some retraction. The surgeon places a guard 28 transvaginally within the bag 18 to protect the integrity of the bag and maintain a closed morcellation system, places a 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 a tenaculum and draws it transvaginally through the powered morcellator 24 to reduce the size of the specimen 16. The surgeon maintains pneumoperitoneum and laparoscopically monitors the progress of the morcellation. Once the specimen 16 has been morcellated sufficiently to withdraw the remaining tissue through the vagina, the morcellator 24, gel cap 44 or stabilizing cap, guard 28, and / or retractors are removed, and the bag 18 and its contents, including pieces generated during morcellation, are withdrawn outside of the patient. The bag 18 maintains a closed morcellation system to prevent small remaining pieces from being left behind in the abdominal cavity 12, as opposed to a traditional morcellation where the surgeon must return and painstakingly locate and retrieve pieces in the pelvic cavity. The surgeon may choose to perform a final laparoscopic view of the patient, and the vaginal stump and abdominal incision are closed.

[0026] 18-19, a retractor 62 is shown having a first ring 64 and a second ring 66 interconnected by a flexible side wall 68. The retractor 62 is described in more detail in one or more of the references incorporated herein by reference. The second ring 66 can be compressed and inserted through a small incision where it expands to form a securement against the abdominal wall 10 inside the cavity 12. The first ring 64 is external to the patient and above the abdominal wall 10 where it can be rolled down to retract and enlarge the abdominal wall opening 14. The retractor 62 can be used with any of the variations described above. In use, the retractor 62 is inserted prior to inserting the bag 18 into the cavity or orifice. In one variation, as shown in FIG. 19, the first ring 64 has a larger diameter than the second ring 66. The larger first ring 64 compared to the second ring 66 allows for more space for working and cutting adjacent tissue. The sidewall 68 is made of a polyurethane laminate or similar material, including a woven material, that is resistant to cutting through the sidewall 68.

[0027] 20A-20B show a modified retractor 62 configured as a bag 70. The bag 70 includes a first ring 64 and a second ring 66 interconnected by a flexible, substantially cylindrical side wall 68. The opening of the second ring 66 is closed by a depending bag portion forming the base 72 of the bag 70. The bag 70 is inserted in a similar manner and used in a similar manner as described above with respect to the bag 18. The second ring 66 is compressed and placed into the abdominal cavity 12 through a small incision. The side wall 68 is rolled around the upper ring 64 to retract and enlarge the opening 14, and a guard 28 connectable to the first ring 64 may or may not be used at the opening inside the bag 70. The specimen 16 is removed manually or via a powered morcellator in the same manner as described above. The first ring 64 is also connectable to a gel cap 44.

[0028] 21-24, a bag 70 is shown having only a first ring 64 forming an opening, a flexible cylindrical side wall 68, and a base 72. The first ring 64 is elastic and compressible into a collapsed elongated configuration suitable for passing through a small incision or through the lumen of a trocar. The arrows in FIG. 22 indicate the longitudinal direction of collapse of the bag 70. The collapsed bag 70 can then be easily compressed laterally to be deployed within the abdominal cavity. The first ring 64 is compressed into an elongated shape. The compressed bag can form its original shape with the first ring 64 expanded. In the expanded configuration, the bag 70 is easily oriented within the cavity 12. The collapsed bag 70 conveniently lies flat inside the abdominal cavity and includes two sides. In the collapsed configuration, the bag 70 has no front side to be on since either side can be used to place a specimen within the confines of the first ring 64. The first ring 64 serves as a circumferential guide for specimen placement and can be brightly colored for easy viewing with a laparoscope. After the specimen is placed within the periphery of the first ring 64, the first ring 64 is grasped and lifted to place the specimen inside the bag 70. The same is true for the two-ring bag 70 described above. As shown in Figures 23-24, the bag 70 can be twisted to form a spiral configuration to collapse the bag or shorten its length. This feature is advantageous not only for inserting the bag through a small incision, but also for lifting the specimen closer to the opening of the bag as it is morcellated.

[0029] 25, there is shown a guard 74 configured for use with the retractor 62 shown in FIGS. 18-19 or with the bag 70 of FIGS. 20-24. The guard 74 includes a rigid ring 76 having 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 as to flex relative to the ring 76, allowing the target tissue 16 to be removed through the flaps 76. The flaps 78 also flex distally to allow instruments to be inserted through the guard. The flaps 78 are made of the same material as the guard 28, e.g., polycarbonate, LDPE, HDPE, or similar material, so that the flaps 78 are sufficiently resilient, cut resistant, and resistant to blade penetration, thereby protecting the retractor 62 or bag 70. The guard 74 may comprise a single ring 76 with a flap 78 or may be comprised of two similar rings 76a, 76b with flaps 78a, 78b, respectively. The two rings 76a, 76b are connected together such that the flap 78a is offset from the flap 78b, thus creating a stacked flap structure that provides protection between the flaps 78a, 78b. The target tissue 16 is raised through the openings 80a, 80b, and the target tissue 16 is cut when within the confines of the guard 76. The target tissue 16 may also be cut when positioned against the flaps 78a, 78b.

[0030] 26, the guard 74 includes an upstanding flat perimeter wall 82 configured to snap-fit ​​under the first ring 64 of the retractor 62 or bag 70 as shown in FIG. 29. The guard 74 may also include a flange 84 configured to snap-fit ​​to the first ring 64 of the retractor 62 or bag 70 as shown in FIG. 28. FIG. 27 shows a rigid guard 74 without flaps. The rigid guard 74 of FIG. 27 provides a large cutting surface that allows target tissue to be positioned and cut without bending as much as a guard 74 with flexible flaps 78. The guard 74 may also include a funnel-shaped depending portion 86, providing greater protection vertically to the bag / retractor 70, 62 and / or wound. The guard 74 is placed over the top of the retractor 62 or bag 70 and within the perimeter of the first ring 64. The guard 74 is then snap-fit ​​under the first ring 64 to join the guard 74 to the first ring 64. The guard 74 also helps to keep the bag 70 or retractor 62 in place while being made of a material that resists penetration when morcellated. In another variation, the guard is configured to snap over the ring.

[0031] 30, a trocar 88 is shown having a first balloon 90 and a second balloon 92. The trocar 88 includes a removable seal housing 94 that houses one or more seals for sealing against an inserted instrument. The trocar 88 includes a central lumen 96 that extends through the seal housing 94 and the trocar 88. The lumen 86 is sized and configured to receive the powered morcellator 24. The trocar 88 may further 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 incision in the abdomen. The bag 18, 62 may be deployed through the lumen 86 and the specimen 16 may be inserted into the bag 18, 62. The tether 22 of the bag 18 or the first ring of the bag 62 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 bag 18, 62 laterally out of the way of 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. A stop formed on the trocar 88 prevents the morcellator 24 from extending beyond the distal end of the trocar 88, which abuts the morcellator 24 and prevents it from moving distally. A tenaculum is inserted into the lumen of the morcellator 24 to grasp the tissue and pull it toward the morcellator. The tissue is cut and removed from the specimen bag. The first balloon 90 is inflated, which is 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 12. FIG. 31 shows another trocar 88 having a seal housing 94 and an insufflation port 98 for inflating at least one balloon 92 .

[0032] 32-39, stabilizer 100 will now be described. Stabilizer 100 includes a flange 102 configured to connect with bag 18, 70 or guard 28. Stabilizer 100 includes a central portion 104, which defines a lumen 106 and houses a lock 108. Lumen 106 is configured sized and shaped to receive powered morcellator 24. Once inserted into lumen 106, the height of morcellator 24 relative to the abdominal wall can be adjusted and then locked into place by lock 108. Lock 108 has an unlocking configuration in which lever 110 is released to allow morcellator 24 to translate longitudinally within lumen 106. Lock 108 also has a locking configuration in which lever 110 is depressed to lock morcellator 24 against translation. Lock 108 operates to increase friction against morcellator 24 shaft to hold it in its position.

[0033] 40-41, stabilizer 100 is shown connected to powered morcellator 24. The system of FIGS. 40-41 includes a toothed bar on morcellator 24 configured to engage an internal pawl (not shown) on central portion 104 of stabilizer 100. A button 114 for releasing and engaging the pawl is shown on stabilizer 100 for unlocking and locking stabilizer 100 from morcellator 24 to free or restrain their relative longitudinal translational motion. Morcellator 24 includes an integral scope and illuminator 116, a gas injection port 118, and a mechanical drive connection 120 for rotating morcellator blade 122. Stabilizer 100 includes a lower flange 102 that extends outwardly to engage a bag or retractor or guard as described above. In one variation, the stabilizer 100 is configured with a safety shutoff mechanism such that activation of the morcellator 24 is prevented when the stabilizer pawl is within a certain range of the toothed bar 112, so that the morcellator 24 will not be activated when it is too distal or beyond the range of the guard and thus may inadvertently contact the bag. Another variation of the stabilizer 100 is shown in Figures 42-43, where like numbers are used to describe like parts. In Figure 43, the stabilizer 100 has a different shape and the pawl element 122 is visible.

[0034] 44-45 show a bag 18 having a tether 22 and a flexible ring 64 at the opening 20. The bag material can be clear or opaque, and the ring 64 is compressible for insertion through a small incision. The side wall 68 can be rolled around the first ring 64 to reduce the height of the bag, thus lifting the specimen closer to the opening, making it more accessible for morcellation.

[0035] Figures 46-47 show a bag deployment tool 124 for the bag 18 of Figure 47. The tool 124 can be inserted through a trocar. The bag 18 includes an opening 20, a tether 22, and a deployment cap 21.

[0036] 48-49 show another bag variation having a first ring 64, a second ring 66, a side wall 68 therebetween, and a base 72. The resilient second ring 66 located at the bottom of the bag 18 causes the bag to flare out when placed inside the body cavity 12 to prevent material from adhering to the specimen 16. After the specimen is placed in the bag 18, the first ring 64 is pulled up to the surface of the abdominal wall 10, as shown in FIG.

[0037] FIG. 50 shows the bag 18 having a first ring 64 made of Nitinol that allows for easy insertion through a small incision while at the same time providing support to keep the bag 18 open inside the abdominal cavity 12.

[0038] 50A-50D show various embodiments of the bag 18 in an uncollapsed or expanded or partially expanded state. As shown, the bag 18 includes a closed end 126 and at least one open end 128. The open end 128, according to various embodiments, includes a tether or drawstring 130 that encircles the open end 128 of the bag 18. Manipulation of the tether 130 opens and closes the open end 128 of the bag 18. The bag 18 includes 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, as shown. The bag 18, according to various embodiments, is shaped so that the bag 18 collapses flat, provides a minimum height, has an open end 128 facing up or toward the opening of the body cavity, has a maximum width, diameter or opening dimension, and tends to point the closed end 126 away from the opening within the body cavity, and is positioned to lie flat and stable along the body cavity. According to various embodiments, when a force is applied in one direction, the height of the walls 134 of the bag 18 increases to trap or surround the specimen within the bag 18. The folds 132 or deformation pattern ensure that the growth of the bag 18 occurs linearly in the direction of the force applied. According to various embodiments, a weight, specimen or opposing force is applied to the bag 18 to further assist in the growth of the bag 18, or in particular the linear growth of the bag 18.

[0039] In one embodiment, the bag 18 is folded flat or in an accordion shape prior to deployment within the patient's body. When the bag 18 is deployed, it is laid flat with the open end 128 of the bag 18 on top and the closed end 126 on the bottom. The closed end 126 rests, for example, on the bottom of the patient's body cavity. Thus, the open end 128 of the bag 18 does not need to be held open because it remains open due to the pattern formed in the wall 134 of the bag 18. Furthermore, due to the pattern, the open end 128 is biased to open and resists closing. This reduces the difficulty and time required to place a specimen on and / or within the bag.

[0040] The surgeon places the specimen on the bag 18, on or over the open end 128 of the bag 18. Pulling on the tether 130 pulls the walls 134 of the bag 18 up and around the specimen, thereby containing the specimen. Opposing forces, i.e., the force of pulling on the tether 130 and the weight of the specimen on the bag 18, unfold or stretch a deformation pattern along the walls 134 of the bag 18. In one embodiment, the bottom or closed end 126 of the bag 18 includes a weight or attachable weight to ensure that a sufficient opposing force is applied to stretch the walls 134 of the bag 18 when the tether 130 is pulled. In one embodiment, one or more tabs 136, i.e., portions of the bag 18 surrounding the open end 128 of the bag 18, are provided to ensure that the force of pulling the bag 18 out or toward an opening in the body cavity also unfolds the walls 134 of the bag 18, or one or more folds 132 of the walls 134.

[0041] In one embodiment, when the weight of the specimen pulls down on the bag 18, it pulls a shorter side of the bag 18 downward, reducing the overall stored size. In various embodiments, to compensate for or reduce the reduction in the overall stored size, one or more tabs 136 are provided at the open end 128 of the bag 18 on the flat side of the bag 18 to prevent the overall stored size of the bag 18 from decreasing. Thus, in one embodiment, when the bag 18 is flattened, the distance along the edge of the bag 18 is greater than the distance along the cross section of the bag 18. The tether 130, in one embodiment, is threaded through the tab 136.

[0042] For a particular desired height and / or width of the bag 18, a pattern such as that shown in FIGS. 50E-50F is used to generate an optimal wall pattern to ensure proper deployment and operation (e.g., stretching and retraction). In one embodiment, the bag 18 is preformed in the pattern shown, and the bag 18 is then heated to maintain the flat, patterned state. A tether 130 is attached to or threaded through a tab 136 at the open end 128 of the bag 18. Thus, the heat, pressure, or preform conditions that place the bag 18 in an initial flat, stable, patterned state help maintain the deformed pattern and force or bias the bag 18 into a collapsed, deformed state when the bag 18 is placed inside the body cavity. A downward force on the center of the bag 18 helps to stretch or unfold the folds 132, thereby expanding or lengthening the height of the bag 18 to encase the specimen. As shown, the valley folds and / or peak folds of the pattern can have the same height and / or width to further ensure a linear and constant or measured increase in size. In various embodiments, the valley folds and / or peak folds of the pattern can have different dimensions to exert equal forces on the inner walls of the cylindrical deployment device, which reduces the force required to deploy the bag 16.

[0043] According to various embodiments, the top or open end and the bottom or closed end of the bag are twisted in alternating directions to create a spiral pattern in the walls of the bag. The bag and / or spiral are heated or compressed to retain their shape. The spiral folds help keep the bag flat after it is inserted into the body. After a specimen is placed on the open end of the bag, pulling on the tether that encircles the open end of the bag causes the walls of the bag to unfold or untwist. Thus, opposing forces, i.e., a pulling force on the tether or open end of the bag and the weight of the specimen and / or weight attached or affixed to the closed end or bottom of the bag, untwist the bag to encase the specimen as it is pulled up toward the opening in the body cavity. According to various embodiments, the open end includes a first ring and / or the closed end includes a second ring. The first and / or second rings may be reinforced or may include wires or rods to bias the open end into an open or expanded state to accept the sample, to increase the tendency of the bag to remain in a flat or unexpanded state, or to provide weight to assist with expansion of the bag or stability in placing the bag or receiving and capturing the sample.

[0044] According to various embodiments, the top or open end and the bottom or closed end of the bag are directly crushed towards each other. The wrinkles or folds in the walls of the bag between the open and closed ends of the bag are heated or compressed to maintain their pattern / shape and help keep the bag flat after it is inserted into the body. After the specimen is placed on the open end of the bag, pulling on the tether that encircles the open end of the bag unwrinkles or straightens the walls of the bag. Thus, opposing forces, i.e., pulling force on the tether or open end of the bag and the weight of the specimen and / or weight attached or affixed to the closed end or bottom of the bag, stretch the bag to encase the specimen as it is pulled up towards the opening in the body cavity. According to various embodiments, the open end includes a first ring and / or the closed end includes a second ring. The first and / or second rings may be reinforced or may include wires or rods to bias the open end into an open or expanded state to accept the sample, to increase the tendency of the bag to remain in a flat or unexpanded state, or to provide weight to assist with expansion of the bag or stability in placing the bag or receiving and capturing the sample.

[0045] As shown in Figures 50G and 50H, the bag 18 can have a variety of top, base and overall shapes, including but not limited to a cube, prism, cylinder, sphere, dodecahedron, hemisphere, cone, rectangular prism, polygon, etc., be surrounded by one or more openings, and include a variety of modified wall patterns, causing 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 contain and encase a specimen therein.

[0046] Various examples of access systems for inclusion or incorporation into morcellation systems, where the entire system, portions of the system, or combinations of systems and / or components thereof are arranged to provide channels and / or protected 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 June 22, 2009; 11 / 374,188, filed March 22, 2006; and US Pat. Nos. 11 / 683,821, filed March 8, 2007; 12 / 396,624, filed March 3, 2009; 14 / 209,161, filed March 13, 2014; 12 / 873,115, filed August 31, 2010; 12 / 840,989, filed July 21, 2010; 11 / 548,758, filed October 12, 2006; 10 / 516,198, filed November 30, 2004; and 10 / 666,579, filed September 17, 2003, the entire disclosures of which are incorporated herein by reference as if fully set forth.

[0047] 51-53, another variation of a guard or shield 200 according to the present invention is shown. The guard 200 has a generally spiral shape. The guard 200 includes a first inner end 202 and a second outer end 204. The first end 202 and the second end 204 are interconnected by a central portion 206, also referred to as a leaf spring or band. The guard 200 has an inner surface 208 and an outer surface 210 interconnected by a top end 212, also referred to as a rear or proximal end, and a bottom end 214, also referred to as a front or distal end, and by the first inner end 202 and the second outer end 204. The central portion 206 or band has a concave outer surface 210, and the inner surface 208 forms a convex following surface when viewed from within the spiral. The concavity of the band is parabolic in one embodiment with an inflection point halfway between the top end 212 and the bottom end 214, but the invention is not so limited and the inflection point may be 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 have a concavity and may simply be a curve or a straight line 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 a top end having the same outer diameter as the bottom end. In another variation, the guard 200 may be asymmetrical in shape and have a top end with a larger or smaller diameter compared to the bottom end. The guard 200 is vertically symmetrical, but the invention is not so limited and the guard 200 may have a central axis at an angle to a reference horizontal plane. The guard 200 has a spiral shape such that one portion of the band overlaps another portion of the band in a curved, circular or elliptical manner. Specifically, at least a portion of the outer surface 210 of the band 200 overlies and faces at least a portion of the inner surface 208 of the band 200 such that the concave surface of one portion of the band 200 is adjacent or juxtaposed with the concave surface of another portion of the band, causing one portion of the band to be seated and nested within the other portion of the band.The spiral is shown having one and a half turns and a resting, mechanically unstressed configuration with a circumferential length of approximately 3πR, where R is the radius measured perpendicular to the long axis of the guard 200. The invention is not limited to a guard 200 having exactly 1.5 turns, but can have more or fewer turns as desired according to its size, shape, and the desired force distribution for a particular incision size and function, such as a retractor function and / or a retention function. A particular advantage of the spiral guard 200 is that its shape and size can be changed, expanded or contracted. In essence, the band can slide against itself to form a larger spiral configuration with a larger diameter or a smaller spiral configuration with a smaller diameter. The spiral guard 200 includes a central lumen 216 formed by the spiral, which can also be expanded when the spiral is expanded or opened. The size of the central lumen 216 can also be reduced when the spiral is closed or reduced in size by sliding the band on itself into a tighter curl to create a greater number of turns compared to a larger curl (which creates a larger diameter with fewer turns). The central lumen 216 is substantially circular, but the invention is not so limited and the central lumen 216 can be oval or irregularly shaped. Thus, the spiral shield 200 is adjustable when inserted into a patient's wound or incision or into a bag placed inside the patient, as described above with respect to the other guards. Depending on the size of the incision, the spiral shield 200 can be adjusted to be larger or smaller by opening or closing the spiral shape and curling the guard on itself to create more turns to fit the wound opening or bag accordingly. Additionally, the spiral shield 200 can be molded to have a predetermined bias that biases it to a particular rest or normal diametric position, shape and size.For example, if an approximately 1 inch incision is made in a patient, the spiral shield 200, which has a resting diameter of approximately 2 inches, can be reduced in size by twisting the shield on itself to increase its turns, thereby reducing its diameter. While in the reduced configuration, the spiral shield 200 is inserted into the 1 inch incision and then released. However, because of the bias molded into the spiral shield 200, the spiral shield 200 tends to be biased toward its normal configuration and thus expands from its reduced configuration, advantageously simultaneously retracting the incision and sealing or exerting a force against the incision to hold the spiral shield 200 and anything between the shield 200 and the incision, such as a bag, in place relative to the patient. Alternatively, the shield 200 can advantageously be reduced under tissue forces when inserted into the incision. The tissue forces on the shield can reduce the diametric 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 distortion on the surrounding tissue, keeps the incision site as small as possible, reducing the risk of infection, while allowing the incision to be backed out and increased in size by opening the spiral when necessary to pull the specimen out of the body. Sometimes the size of the tissue to be removed can be unpredictable, and this adjustability advantageously allows for easy removal of larger tissue specimens without creating difficulties for the physician.

[0048] The position of the spiral shield 200 is further advantageously held against the incision site or natural orifice, such as the vagina, with the aid of the curvature or concavity of the band. Specifically, the top end 212 forms an upper lip, also referred to as an upper flange, which extends circumferentially at least partially on the upper surface of the tissue. The bottom end 214 forms a bottom lip or flange, which extends circumferentially at least partially on the lower surface of the tissue within the patient's body cavity, abdominal wall, or surgical working space, advantageously retracting the tissue away from the cutting surface of the shield 200, which is generally the inner surface 208 of the band. The tissue is received against the outer surface 210 of the band and seats within the concave or curved shape of the outer surface 210, holding the shield and containment bag in place with the flange and preventing the shield from slipping down into the patient or sliding up and out of the patient. Of course, the shield 200 may be placed directly into the surgical incision / orifice or placed into any one or more of the containment bags and wound retractors described above. Morcellation can proceed in any manner or style selected by the surgeon, including using the inner surface 208 of the shield 200 as a cutting board against which a blade can be used to cut tissue drawn through or into the central lumen 216 by the grasper. 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 guard 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 shield material has a thickness optimized to protect the tissue without puncturing or tearing when cutting against it. When the morcellation is completed, the spiral shield 200 can be reduced in diameter into a reduced configuration by rolling the shield onto itself for easy removal from the surgical site. Alternatively, the shield 200 can be removed by pulling the shield 200 vertically or along the long axis of the shield.

[0049] 52-53 show the spiral shield 200 on the core pin of the forming mold 220 having a helical shape. To manufacture the spiral shield 200 by injection molding, the shield 200 is molded on the helical mold 220. Once the core pin of the mold 220 is unwound off, the shield 200 can be made to conform to its functional spiral form by pushing one end in front of or behind the adjacent turns. Because the shield 200 is first formed into a helical shape and then made to conform to a spiral, it has some memory of springback tension within it and tends to assume a helical shape instead of remaining a perfect spiral. If the shield 200 has an undesirable excess amount of spring bias tension, an annealing process can be performed by placing the shield 200 in a moderately heated oven for an allotted time and then removing it, which reduces or relieves the residual tension in the shield 200. However, in one variation of the shield 200, some residual tension is advantageously desired because the tendency of the shield 200 to expand along its long axis facilitates removal of the device from the incision site. The shield 200 may be formed with a tab (not shown) on one end, such as the proximal, inner or outer end, and / or may be formed with a hole near one end of the shield through which a drawstring can be attached, allowing the surgeon to easily pull the string or tab to remove the shield 200 from the incision site. The tab or hole may indicate a directional preference for inserting the shield, allowing helical tension to be utilized when removing the device with the tab / hole proximal to the surgeon outside the patient. In one variation, the first inner end 202 that follows the inside of the winding may be provided with a tab or hole for this removal feature. As the inner end 202 is pulled vertically during removal, the bands of the shield will gradually uncoil and move out of the incision.

[0050] As an alternative to injection molding, the spiral shield 200 can be manufactured from plastic sheet stock that is die cut and thermoformed into the desired shape. Also, instead of injection molding the shield 200 into a spiral shape, the spiral shield 200 can be injection molded directly into the spiral shape.

[0051] 71A and 71B, the shield 200 is shown in an expanded elongated configuration and a compressed or unexpanded configuration, respectively. The expanded configuration of the shield 200 is also shown in FIGS. 72-74. The shield 200 in the expanded configuration can be converted to a compressed configuration by overlapping the inner surface 208 onto the outer surface 210. The compressed configuration of the shield 200 is also shown in FIGS. 76-79. At least a portion of the shield 200 overlaps itself in the unexpanded configuration, as clearly shown in FIGS. 78A-78C. In FIG. 78C, one portion of the shield 200 is shown nested within the concavity of the outer surface 210 of an adjacent overlapped portion of the shield 200. The shield 200 is adapted to be at least partially rolled or curled about the longitudinal axis 218. The shield 200 is adapted to be at least partially rolled or curled on itself about the longitudinal axis 218 such that a portion of the shield 200 overlaps or rests in juxtaposition or contact with another portion of the shield 200. When in the unexpanded configuration of FIG. 71B, the shield 200 has a relaxed or normal lateral configuration in addition to a compact configuration in which the unexpanded configuration is rolled into a tight roll having a reduced diametric or lateral dimension suitable for insertion into a wound or orifice. The shield 200 has a bias towards the relaxed or normal lateral configuration and tends to be biased towards this bias after being inserted into a wound or orifice and as the shield 200 expands from the compact configuration to the larger configuration, it exerts some retraction force on the tissue depending on the material used for the shield 200 and the force exerted by the surrounding tissue in response to the shield 200 being inserted. If the wound or orifice is tight, the shield 200 may not expand from its contracted laterally insertion configuration, or it may unroll slightly and expand slightly in the lateral dimension as it attempts to reach its normal relaxed configuration, or the shield 200 may expand all the way to its normal relaxed configuration.

[0052] The longitudinally expanded configuration of the shield 200 shown in FIG. 71A is the result of it being molded on a helical mold 220. The shield 200 defines a longitudinal axis 218 about which the shield 200 is centered. The shield 200 is made of a material that is biased at least in part toward a longitudinally expanded position. The shield 200 can be made of a shape memory material or can include components made of a shape memory material. When in the longitudinally compressed configuration, the bias toward the longitudinally expanded position does not cause the shield 200 to spring suddenly into the longitudinally expanded configuration because the concave outer surface forms a top lip, also called top flange 222, and a bottom lip, also called bottom flange 224, at least a portion of which is adapted to abut against the adjacent overlapping top flange 222 while in the compressed configuration, and at least a portion of which is adapted to abut against the adjacent bottom flange 224 while in the compressed configuration, thus preventing the longitudinally compressed configuration from suddenly and easily reverting to the longitudinally expanded configuration. At least one of the top flange 222 and the bottom flange 224 serves as a stop that prevents the shield 200 from expanding from the compressed configuration to the expanded configuration. The bias towards the expanded configuration provides a degree of friction against the device itself, which aids in regulating the lateral dimension or diametric expansion of the shield 200. When in the compressed configuration, the shield 200 can be rolled / curled about its long axis to reduce its diametric or lateral dimension, which can reduce the size of the shield 200 and reduce the diameter of the central lumen 216, making it easier to insert through a small, minimally invasive incision or orifice.

[0053] FIG. 80 shows the shield 200 in a relaxed or normal lateral configuration with circumferential turns of approximately 1.25 times the circumference, and shows the central lumen 216 along with the shield inner or lumen diameter 226 and the shield diameter 228 or outer diameter, both of which serve as the lateral or diametric dimensions of the shield 200. FIG. 81 shows a top view of the shield 200. In FIG. 81, the shield 200 is in a compact configuration suitable for insertion into an incision / orifice, where the shield 200 is rolled on itself into a tighter roll. The shield 200 in FIG. 81 has circumferential turns of approximately 2.25 or more times the circumference, and has a reduced lumen diameter 226 and shield diameter 228 compared to the relaxed normal configuration of FIG. 80. The overlapping portions of the shield 200 contact each other and act to slightly frictionally hold the reduced lateral dimension position, but the lateral dimension bias is biased toward the unstressed or relaxed radial normal configuration so that the shield 200 tends to the normal configuration. The compact configuration with reduced lateral dimensions is appropriately adapted for insertion into a wound or orifice. From the compact configuration, the shield 200 expands from the reduced lateral dimension position toward the normal unstressed lateral dimension configuration when released outside the wound or orifice. This expansion in situ may be limited by the force exerted by the tissue in response to the force exerted by the inserted shield 200. The shield 200 includes a central lumen 216 having a circular shape and diameter, but the invention is not so limited and variations include the shield 200 having an elongated lumen 216, such as an oval or ellipse, having a length greater than its width. Thus, 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 corresponds to 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.

[0054] As discussed above, the shield 200 includes a top flange 222 and a bottom flange 224 as part of the concave outer surface 210 of the shield 200. During a longitudinally unexpanded configuration, the shield 200 is generally symmetrical about a plane perpendicular to the longitudinal axis 218, where the top flange 222 and the bottom flange 224 extend approximately equal distances radially outward from the longitudinal axis 218 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 a greater distance than the bottom flange 224 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 upper flange 222 advantageously provides a larger protective surface area for the surrounding tissue and / or containment bag, as well as a larger cutting board surface for the surgeon to use when morcellating / reducing tissue.

[0055] 82, a variation of the shield 200 is shown having a finger pull or tab 230. The tab 230 is shown as being integrally formed at or near the first inner end 202 of the shield 200. The tab 230 extends from the first inner end 202 and from the top end 212 of the shield 200 to form an extension adapted for easy grasping by a user with either the user's finger or an instrument such as a grasper. In one variation, the tab 230 includes a hole 232 configured to provide a location for insertion of an instrument or finger. In another variation, the hole 232 is not present. The tab 230 is configured such that when it is pulled in a generally upward or proximal direction, the shield 200 transforms from an unexpanded configuration to an expanded configuration. Applying an upward force to the first end 202 via the tab 230 results in the bottom flange 224 of the first end 202 unhooking or moving from the adjacent lower flange 224 of the shield 200, separating the first end 202 from its nested position with the overlapping curvature of the adjacent shield 200 portion. As the proximal end of the tab 230 is pulled upward, it directs a longitudinal expansion of the shield 200, resulting in the first inner end 202 moving out of its unexpanded configuration first, leading the remainder of the shield 200 to gradually move out of the nested apposition of the unexpanded configuration, leading to the spiral shape of the shield 200 in the expanded configuration. FIG. 82 shows the shield 200 in its unexpanded configuration and the tab 230 formed integrally 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, the tab 230 includes a tether attached to the shield 200 , and in another variation, the tab 230 is a tether and is not an extension of the shield 200 .

[0056] 83-84, 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 when it is in an unexpanded configuration. When the shield 200 is deployed in situ, the forces of the surrounding tissue may force the lateral or diametric dimension of the shield 200 to be smaller than desired. Although the shield 200 may include a relaxed rest configuration while in an unexpanded configuration, the bias built into the shield 200 may not always be sufficient to overcome the forces of the surrounding tissue or may be less than the surgeon's preference for a particular procedure or for a particular instrument passing through the central lumen 216 or for a particularly large specimen of target tissue. In either case, the lock 234 is configured to lock and hold the lateral or diametric dimension of the shield 200 substantially fixed, particularly preventing reduction in the lateral or diametric dimension due to forces from the surrounding tissue. For example, when the shield 200 is inserted into an incision or orifice that is relatively smaller than the lateral dimension of the shield 200, it is first reduced to a compact configuration as shown in FIG. 81. While in the compact configuration, the shield 200 is inserted into the wound or orifice. The force of the surrounding tissue in response to the inserted shield 200 may be greater than the bias that urges the shield 200 back to its unstressed, relaxed normal configuration. In such a case, the surgeon may desire a larger central lumen 216 for the shield 200 or may desire to retract the surrounding tissue. The surgeon then unrolls the shield 200 into a larger lateral or larger diametric configuration and locks it into place with a lock 234 provided on the shield 200. In one variation, the lock 234 includes a first notch 236 located a distance proximal to the first end 202 of the shield 200 and near the top end 212, and a second notch 238 located a distance proximal to the second outer end 204 of the shield 200 and near the top end 212. The notches 236, 238 are located proximal to 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.To lock the shield 200, the shield 200 is expanded in the lateral dimension by unrolling the shield 200 to form a larger central lumen 216. The first notch 236 overlaps with the second notch 238 to lock the shield 200 in a fixed diametric / radial position, while the remaining portion of the shield 200 maintains some overlap circumferentially around the outer circumference of the shield 200. FIG. 84 shows the first notch 236 overlapping or interlocking with the second notch 238 in a locked configuration. During the locked configuration, at least a portion of the first end 202 is located outside at least a portion of the second end 204, such that a portion of the inner surface 208 of the first notch 236 faces the outer surface 210 of the second notch 238. To unlock the shield 200, the notches 236, 238 are unhooked from one another.

[0057] As mentioned above, the shield 200 can be inserted into a wound or orifice by rolling and / or squashing it to a smaller diameter and then inserting it into the wound or shield. Insertion of the shield 200 can be facilitated with conventional surgical instruments such as clamps or graspers. Once inserted, the shield 200 naturally opens slightly and the tissue yields to the outside of its configuration. In one variation, the shield includes a lock 234 that allows the shield 200 to be locked into a diameter slightly larger than the diameter it would naturally close. The lock 234 includes notches 236, 238 along the outer edge of the shield 200 near the first and second ends 202, 204 where the spiraled material overlaps. The notches 236, 238 overlap when in a locked configuration to snap together such that at least a portion of the inner end of the shield 200 is outside the outer end of the shield 200. The exposed tabs of the lock 234 can be pinched into an overlapping configuration that provides a mechanical interlock point.

[0058] 85-86, another variation of the lock 234 on the shield 200 is shown. The lock 234 includes interlocking teeth. Specifically, a first set of outer teeth 240 are formed on the outer surface 210 near the first inner end 202 of the shield 200, and a second set of inner teeth 242 are formed on the inner surface 208 near the second outer end 204 of the shield 200. The first set of outer teeth 240 are located in a concave surface near the first inner end 202 and extend substantially longitudinally. The second set of inner teeth 242 are located in a convex surface near the second outer end 204 and extend substantially longitudinally. The outer teeth 240 and inner teeth 242 can also be angled. In one variation, the teeth 240, 242 are angled to allow them to more easily slide or tilt over one another 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 contracting laterally due to tissue forces at the wound or orifice. The outer teeth 240 and inner teeth 242 are configured to interlock with one another to prevent contraction of the lateral dimension of the shield 200. The plurality of inner teeth 240 and the plurality of outer teeth 242 are formed along at least a portion of the circumference near the first and second ends 202, 204 such that the location at which the shield 200 is locked can be adjusted as needed to fix the lateral dimension as desired. Although the teeth 240, 242 are shown as being located at a midline perpendicular to the longitudinal axis 218, the present invention can include teeth located anywhere along the longitudinal dimension.

[0059] In another variation of the lock on the shield 200, the shield 200 can be provided with a protuberance extending from an inner surface. The protuberance can be shaped like a hook and configured to engage with a notch or opening formed in an adjacent portion of the shield 200. In one variation, the protuberance is 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.

[0060] The shield 200 guards tissue surrounding a wound or orifice in the body from sharp objects such as blades or morcellators during surgery. The terms wound, orifice, incision, and body opening are used interchangeably herein. A wound is generally a minimally invasive incision made through the abdominal wall for laparoscopic or other types of surgery. The shield 200 is a spiral spring in an expanded configuration that includes a ribbon of material formed into a spiral shape, which generates an outward force when inserted into the wound or orifice. The shield 200 also retracts tissue within the wound or orifice to provide an opening across the abdominal wall or through the orifice via a central lumen 216 that is generally circular when viewed along a long axis 218. In one variation of the shield 200, the shield 200 is not curved, but is made by rolling a ribbon of generally flat material into a cylindrical or conical form. In another variation, the curved ribbon shield 200 has a C-shaped longitudinal cross section when viewed from the side. The proximal and distal edges, also referred to as the upper and lower ends 212 and 214, are larger in diameter than the middle portion of the shield 200, forming top and bottom flanges 222 and 224, respectively. This C-shaped configuration advantageously cups the tissue at the wound opening to provide an anchor-like fixation so that the shield 200 does not easily axially dislodge from the wound or orifice during normal use. In one variation, the C-shape is parabolic, 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 upper or lower ends 212 and 214 and the longitudinal midline.

[0061] Removal of the shield 200 from the wound or orifice is accomplished by first disengaging any interlocking features 234, then grasping the exposed inner corners of the shield 200, curling it inward in the direction of the spiral of material, and then pulling it upward along its long axis and out of the wound or orifice. The shield 200 advantageously pivots out like a corkscrew into the spiral form of the expanded configuration. The shield 200 can be pulled out manually using fingers or with the assistance of a common surgical instrument such as a clamp or grasper. One variation of the shield 200 is made of a cut-resistant yet flexible plastic material. The material selection and thickness provide the protective features. The shield 200 is flexible enough for insertion and removal, yet rigid enough to remain secured and provide protection.

[0062] The shield 200 provides several advantageous features. One important feature provided by the shield 200 is protection of the surrounding tissue from sharp objects such as blades, scalpels, and morcellators. The shield 200 also provides protection to the containment bag in which it is placed, thereby protecting the containment bag from puncture or cutting by sharp objects and ensuring containment of the biological specimen is maintained with reduced risk of leakage. The top flange 222 provides a broad base or cutting board-like protection to the tissue and bag surfaces surrounding the wound or orifice. The top flange 222 overlaps, covers, and protects the tissue edges and / or containment bag. The middle portion of the shield 200 also shields the tissue at the wound or orifice and protects the containment bag in which it is placed if a containment bag is used. The intermediate section further advantageously allows the surgeon to reach deeper with the blade and cut tissue specimens proximal or superior to the midline horizontal plane perpendicular to the long axis, as well as reach distally beyond the midline plane of the shield 200 to cut tissue specimens, since the entire longitudinal length of the shield 200 provides protection against surrounding tissue and the containment bag.

[0063] Another advantage of the shield 200 is that it includes an anchoring feature. The shield 200 is advantageously configured to anchor itself within the wound and orifice via a C-shaped design. The anchoring feature dramatically makes the morcellation procedure easier and faster since no sutures or extra hands are required to hold the shield 200 in place during the normal procedure. Dual flanges (top and bottom 222, 224) are provided to capture tissue or abdominal wall within the concave surface of the C-shape to anchor the shield 200. The shield has a distal anchoring member for an internal location within the wound and a proximal anchoring member for an external location of the wound opening. A single flange on either the top or bottom is also within the scope of the present invention. Additionally, while the top flange 222 and bottom flange 224 are shown extending around the entire circumference of the top end 212 and bottom end 214, respectively, the invention is not so limited and any one or more of the top and bottom flanges 222, 224 may extend around at least a portion of the circumference. In such variations, finger-like extensions may be formed in place of the circumferential bottom flange 224. The fingers may be easily bent along the length to facilitate insertion and then spring radially outward into an anchoring position beneath the abdominal wall or other tissue or orifice. Additionally, the top flange 222 may extend radially outward a greater distance than the bottom flange 224, or vice versa, as shown in FIG. 79, to provide a larger cutting board-like surface.

[0064] Additionally, the shield 200 is advantageously adapted for easy insertion and removal from a wound or orifice. The shield 200 includes a longitudinally expanded configuration and a longitudinally unexpanded configuration, giving the shield 200 longitudinal flexibility. This allows the shield 200 to be easily removed by simply pulling one end of the shield 200 proximally, and the shield 200 unhooks from the adjacent overlapping flanges and / or concavities and pivots like a corkscrew to an expanded spiral shape from the nested, unexpanded configuration. Tabs, holes, and / or tethers 230 are provided to assist in grasping and longitudinally pulling the shield 200. Additionally, while in the nested or unexpanded configuration, the shield 200 is movable and can be rolled or curled on itself to form smaller or tighter circles and more rotations around itself to a compact configuration. The shield 200 is advantageously moved from a laterally compact configuration by releasing the compact configuration to assume a normal relaxed configuration having a relatively large lateral dimension. A larger configuration may also be provided by the shield 200, where a lateral or diametric position larger than the normal or relaxed configuration may be locked in place by a lock 234 formed in the shield 200. The lateral flexibility of the shield 200 allows the lateral dimension to be reduced to facilitate insertion into a wound or orifice. Also, from the locked, diametrically increased position, the shield 200 may be unlocked and reduced in size in the lateral dimension by simply unlocking the shield and / or by unlocking the shield and then curling it on itself to a tighter configuration, thereby facilitating removal from a wound or orifice.

[0065] The shield 200 is advantageously self-deploying. After curling the shield 200 into a compact lateral configuration, it is easily inserted into a wound or orifice and then when released, tends to expand in size due to its spring bias. This lateral spring-back action helps the shield 200 to automatically seat in the wound or orifice with little effort, while at the same time providing protection and retention for the tissue and / or containment bag, keeping both out of the path of sharp objects that may be encountered during a typical procedure.

[0066] Moreover, while in a longitudinally unexpanded configuration, shield 200 has a generally C-shaped or hourglass-shaped profile, where the proximal end flares radially outward from the longitudinal axis, the distal end of shield 200 flares radially outward from the longitudinal axis, and the barrel is 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 sloping surface or funnel that guides and moves target tissue into and through shield 200.

[0067] The flexibility of the shield 200 allows it to be excellent in insertion, deployment, removal, and in becoming an anchor due to expansion. The flexibility is advantageously balanced against its ability to provide protection to the surrounding tissue and / or containment bag. The protection that the shield 200 provides is sufficient for a manual morcellation procedure when performed properly, while also giving the surgeon the freedom to use their personal morcellation technique. The shield 200 is inserted into the mouth of the containment bag and can also be placed in the neck of the containment bag or in the main receptacle of the containment bag. The containment bag surrounds the shield 200 and is captured between the tissue / orifice 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 so that the containment bag is substantially fixed and held in place and does not slide into the wound or orifice. A sufficient amount of the proximal end of the bag is located proximal to the shield to overlap an exterior surface, such as the patient's abdomen, to form a blanket to help prevent contamination. The shield 200 is configured to hold the mouth of the containment bag in an accessible open configuration to receive and support a manual or powered morcellator device.

[0068] In another variation, the shield 200 is adapted for insertion into the vaginal canal and therefore is longer than the length shown. The shield 200 may also include a shape memory component to aid in deployment. The shield 200 provides reliable and safe removal of endogenous samples, is easy to use, and reduces surgical time and costs. The shield 200, in combination with a storage bag, helps reduce the risk of healthy tissue being contaminated with potentially malignant cells during tissue sampling.

[0069] With reference to Figures 54-59, a bag 310 according to the present invention will now be described. The bag 310 includes a single opening or mouth 312. At or near the mouth 312 of the bag, a semi-rigid compressible plastic ring 314 is connected within the bag 310. The ring 314 can be compressed from a circular or larger configuration to an oval or smaller configuration so that the bag 310 can be inserted through a small incision. Once inside the patient, the elastic ring 314 expands to its original uncompressed larger configuration, opening the mouth 312 of the bag 310 therewith. When laid flat inside the patient, the ring 314 clearly defines the opening 312 of the bag 310, which may be difficult to see under laparoscopic observation if not for the ring 314. Sometimes the opening 312 of the bag 310 can be difficult to find. In that case, the opening 312 must be oriented inside the patient so that tissue is clearly placed within it and not past the opening 312. In the present invention, the expanded ring 314, when placed on top of the bag 310, ensures that any tissue disposed within the ring 314 will eventually be inside the bag 310 when the ring 314 is lifted towards the incision. The empty bag 310 is placed flat on a flat surface and the ring 314 will naturally fall onto the bag 310. The elastic ring 314 allows the bag 310 to remain open unassisted inside the abdominal cavity, facilitating tissue capture.

[0070] After the tissue sample is placed inside the ring 314, the ring 314 is pulled up towards the incision. A tether 316 is provided near the mouth 312 of the bag 310 to assist the surgeon in pulling the bag 310 up towards the incision. The tether 316 can have a tag 318 at its proximal end that is retained outside the patient when the bag 310 is placed inside the patient. The tag 318 is also easy to find inside the patient. The large tag 318 aids in quickly locating and pulling the tether 16 when needed. The tether 316 can also be configured to cinch the bag 310 closed to prevent the contents of the bag 310 from spilling out. Alternatively, there may be additional tightening strings connected to the bag 310 and located above or below the ring 314 to close the bag 310 circumferentially. Other methods of closure or sealing, such as a press fit or zipper, can also be provided.

[0071] When the bag 310 is pulled to position it near the incision, the ring 314 is compressed from its expanded configuration to its compressed configuration so that it can be pulled through a small incision. The ring 314 is compressed by a grasper or by hand through the opening of the incision. After the ring 314 is pulled through the incision, a sufficient amount of the bag 310 is pulled with it to rest over and cover a portion of the patient's abdomen. Therefore, the bag 310 must be fairly large to create an apron effect around the incision outside the patient. With the ring 314 and a portion of the bag 310 outside the patient, the remainder of the bag 310 and the tissue specimen remain inside the patient.

[0072] The cross section of the ring 314 may be circular and may have a hollow center to provide flexibility. In one variation, the ring 314 has an elliptical, elongated or oval cross section. In the variation shown in the drawings, the ring 314 has a shape similar to the number 8, i.e., two connected circular cross sections with a small valley 320 between the circles. In general, the cross section of the ring 314 has a length greater than its width. This elongated cross section allows the ring 314 to be rolled or flipped on itself by inverting the ring 314 outwardly or inwardly to roll up the bag 310 on itself. The ring 314 can be rolled in the opposite direction to unfold the bag 310 from the ring 314. The elongated cross section of the ring 314 advantageously keeps the side walls of the bag 310 rolled up on the ring 314. If the cross section was circular, the ring 314 could be rolled more easily, thereby unravelling the rolled up side walls of the bag 310. The rolling of the ring 314 on itself draws the bag 310 upward, bringing the specimen within the bag 310 closer to the opening of the incision. The rolling action of the bag 310 reduces the volume of the bag 310 inside the patient and also forms a well-formed, taut apron on the outside of the patient. If the bag 310 is retracted too tightly, the ring 314 may become distorted. The tissue specimen is then drawn from the bag 310 by morcellating it with a blade or powered morcellator to a size and shape that allows it to be passed through a small incision and removed from the bag 310. As shown in FIG. 59, to facilitate deployment, the side wall 328 of the bag 310 can be rolled up on itself to form a roll 330 that is located adjacent to the ring 314. To facilitate insertion, the ring 314 is crushed so that the compressed length of the ring 314 aligns with the length of the roll 330.

[0073] With particular reference to Figures 55-56, the ring 314 is formed from a single elongated plastic piece 322 and formed into a circle or other shape by joining the free ends together. In another variation, the ring 314 is made of two or more pieces, such as two semicircles, that together define a circle of the same radius. The ends are not connected, but are held in a regular curved configuration inside the sleeve at the mouth of the bag 310. The multi-piece ring 314 makes it easier to compress the ring 314 into a smaller configuration. The ring 314 is approximately 0.38 inches high and 0.18 wide, and is approximately 38 inches long. The thickness of the material forming the ring 314 is approximately 0.18 inches.

[0074] With particular reference to Figures 57-59, the bag 310 is formed from a single sheet 324 of material. The sheet 324 of material is folded lengthwise and the sides are heat sealed to form a seam 326. The weakest point of any bag 310 is the area around the welded seam 326. As can be seen from Figure 57, the welded seam 326 is absent at the bottom of the bag 310 where the forces are most likely to be concentrated during specimen removal, which gives the bag 310 a greater marginal strength. The material of the bag 310 is also made from 4.2 mil Inzii® film, which is clear and allows the surgeon to see through the sides of the bag 310 during surgery. Visibility through the bag 310 eliminates the need to puncture the sides of the bag 310 to achieve visualization. The film is elastic and gives the bag 310 good retraction. The bag 310 can also be made from U-5746 ripstop nylon with a polyurethane coating. The polyurethane coating makes the film airtight and heat sealable. U-5746 is a military grade material that is stronger than Inzii® film, but has less recession and is opaque. The bag 310 is approximately 16 inches long and 12 inches wide at the mouth 312. The bottom of the bag 310 forms an approximately 45 degree angle with the sidewall 328 at a distance of approximately 12.4 inches from the mouth 312. The bag 310 has a thickness of approximately 0.2 inches, and at the seam 326, the bag 310 is approximately twice as thick. In another variation, the bag 310 is double bagged, one bag located inside the other, providing higher resistance to accidental punctures. In another variation, the bottom portion of the bag 310 is reinforced with a double wall construction. The bag 310 is leakproof and prevents the entry of viruses.

[0075] As previously described, a shield may be prepared and used in conjunction with the bag 310. The shield is inserted into the mouth 312 of the containment bag 310 after the bag 310 is placed within the patient and pulled through the incision. The shield is made of a thicker plastic to prevent the plastic bag 310 from being inadvertently cut by the blade used by the surgeon to morcellate the target tissue. The shield also serves as a cutting board against which the surgeon can access and cut the target tissue when necessary. The bag 310 may also be used with a retractor as described above, in which case the retractor is placed within the mouth 312 of the bag 310 as the bag 310 is pulled through the incision, and the tissue and bag 310 at the incision are retracted before the shield is placed within the retractor to remove the specimen.

[0076] 60-63, a bag introducer or fork 410 is used to introduce the containment bag 310 into a patient's body cavity through a small incision. The introducer 410 facilitates positioning 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 prong 418 and a second prong 420 extend distally from the handle 416 to form a generally fork-like configuration. The prongs 418, 420 are of equal length. The prongs 418, 420 can have any suitable cross-section and are spaced a sufficient distance from each other. The prongs 418, 420 are made of stainless steel and are connected to an injection molded plastic or metal handle 416 as shown in FIG. In this design, the steel rod containing the prongs 418, 420 is inserted into and connected to an injection molded handle 416, which allows the fork 410 to have a small profile, but is more expensive and takes longer to manufacture. In Fig. 61, the fork 410 is made from a single piece of material, with both the handle 416 and the prongs 418, 420 being injection molded to form a one-piece structure. This design is the easiest and cheapest to manufacture, but at the cost of a larger profile and weaker design.

[0077] In use, and with particular reference to Figures 62-63, the bottom of the storage bag 310 is placed between the prongs 418 and 420, and the tether 316 and tag 318 are placed near the handle 416. The bottom edge of the bag 310 is folded over the prongs 418, 420, which extend slightly beyond the ends of the bag 310. Thus, the prongs 418, 420 are slightly longer than the width of the bag 310. By grasping and rotating the handle 416, the bag 310 is evenly rolled up into the tubular roll 330 until resistance is met. The bag 310 is reduced to a minimum size for introduction into the formless area. The elastic ring 314 is crushed and the bag 310 is rolled up until it is taut and located next to the ring 314. Under visual control, the bag 310 and fork 410 combination is inserted through the incision, ensuring that the opening 312 of the ring 314 is positioned upwards. The bag 310 is inserted until it is approximately three-quarters of the way into the incision. The fork 410 is rotated in the opposite direction to loosen the bag 310 slightly. Loosening the bag 410 and reducing the tension on the bag allows tissue to drop into the bag 310 more easily. The fork 410 allows the bag 310 to be easily deployed while controlling how tightly the bag 310 is wrapped and the direction of the ring opening 312. If the bag 310 is wrapped too tightly, tissue will not easily drop into the bag 310 when the ring 310 is lifted inside the patient. Rotating the introducer 410 in the opposite direction before removing the introducer 410 facilitates easy tissue insertion into the bag 310.

[0078] The fork 410 is separated from the bag 310 by pulling the handle 416 proximally. The remaining quarter section of the bag 310 is pushed into the incision. After the bag 310 is fully deployed in the abdominal cavity, an access port and scope are placed and the cavity is insufflated. The bag 310 is positioned so that the ring 314 is on top of the bag 310. The access port can be placed in the same incision or in a secondary incision. Under visual observation, the tissue to be morcellated and removed from the patient is placed in the bag 310. A lateral access port can be used to visualize and confirm that the tissue is inside the bag 310. The access port is removed and removal of the bag 310 outside of the patient begins. The secondary access port does not necessarily have to be removed and can be used to continue observing the removal and subsequent morcellation. The tag 318 can be outside the patient. It is pulled to pull the bag 310 up towards the incision. Once the tag 318 is in the cavity, visualization through the access port and a grasper can be used to grasp the tag 318. The tether 316 and tag 318 are pulled up through the incision until the ring 314 passes 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 on itself, rolling the bag 310 around the ring 314. This rolling of the ring 314 not only retracts the tissue slightly, but also reduces the volume of the bag 310 inside the patient, drawing the tissue inside the patient closer to the surface. The tissue is then morcellated.

[0079] Alternatively, a retractor with a central lumen is placed inside the mouth of the bag 310 at the incision, tissue is retracted with the bag 310 to enlarge the opening, and then the tissue is morcellated with the bag 310 in place. A retractor with a central lumen is placed inside the mouth of the bag 310 at the incision, and a shield as previously described is prepared and used in combination with the bag 310 and the retractor. The shield is placed inside the central lumen of the retractor. Of course, the shield can be used without the retractor. If a retractor is not used, the shield is placed inside 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 a thicker plastic to prevent the plastic bag 310 from inadvertently being cut by a blade or other instrument used by the surgeon to morcellate the target tissue. The shield also serves as a cutting board against which the surgeon can cut the target tissue when necessary. The shield itself can also function as a retractor having a first, reduced dimension and a second, expanded dimension that serves to retract tissue.

[0080] When a retractor is used inside the bag 310, the retractor advantageously not only retracts tissue, but also retracts a portion of the bag to keep the bag out of the path of the morcellation blade, thereby protecting the bag from cutting and puncturing. A typical retractor includes a top ring and a bottom ring with a flexible side wall connecting them. The bottom ring is inserted through the incision and resides inside the patient, while the top ring of the retractor resides above the patient. The top ring, like the bag, is rolled / flipped on itself to pull the bottom ring of the retractor closer, bringing the side walls into a taut relationship between the rings. The bottom ring of the retractor advantageously retracts a portion of the bag 310 inside the patient, away from potential damage that may result from puncture and tearing from the blade.

[0081] The tissue is morcellated in a manner desired by the surgeon. Generally, a small portion of the target tissue is pulled outside the patient while a larger portion of the target tissue remains inside the patient. The surgeon uses the blade to make approximately 180 or 360 degree circumferential cuts around the circumference of the protruding tissue without severing it from the remainder of the target tissue. Keeping the protruding tissue intact with the larger piece inside the patient allows the surgeon to continue to grasp the tissue without losing it inside the bag. The surgeon periodically makes circumferential cuts of any size while pulling the grasped tissue out of the patient in small increments, allowing more tissue to be pulled before removing an entire piece of the target tissue. The result is a single elongated piece of target tissue that is removed instead of multiple smaller pieces. If not removed in one piece, the target tissue is removed in fewer pieces and in a more controlled manner. The bag 310 can be retracted further during morcellation to bring the specimen closer to the surface. Once the tissue remaining within the bag 310 is small enough to easily pass through the incision, the bag 310 is completely removed.

[0082] 64-65, another shield 510 according to the present invention is shown. The shield 510 comprises a first ring 512 at a proximal end 514 and a second ring 516 at a distal end 518. The rings 512, 516 are substantially parallel to one another and interconnected by a sidewall 520. The sidewall 520 is a fabric sheath material, which can be made of a flexible textile or polymer. The material can be Kevlar®, Dyneema®, ripstop nylon, or a polymer blend material. The sidewall 520 is heat sealed or 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 or can be elliptical. The rings 512, 516 can be compressed from a circular or large configuration to an oval or smaller configuration so that the shield 510 can be inserted into a small incision, particularly into the mouth of a containment bag to protect it. In one variation, only the second ring 516 is compressible for insertion into the incision and the first ring 512 is rigid, with the first ring 51 intended to remain proximally on or inside the patient. The rigid proximal first ring 512 can be larger and wider to act as a larger shield or cutting board for morcellation. The second or distally positioned ring 516 is flexible for compression and easy insertion into the bag and may be slightly smaller in diameter than the first ring 512.

[0083] The cross section of one or more of the rings 512, 516 can be circular. The rings 512, 516 have a hollow center to provide flexibility. In one variation, the rings 512, 516 have an oval, elongated, or elliptical shape with a hollow center. In another variation, the rings 512, 516 have two connected circular cross sections resembling the number 8 with a small valley between the circles, as shown in Figures 55A-55B. In general, the cross section of the rings 512, 516 has a length greater than its width. This elongated cross section allows the rings 512, 516 to be rolled or flipped on themselves by inverting the rings 512, 516 outwardly or inwardly to roll up the side walls 520 onto themselves. In one variation, only the first or proximal ring 512 is configured to roll up the side walls 520. In another variation, both rings 512, 516 can be configured to roll, making the shield 510 bidirectional, i.e., either the first ring 512 or the second ring 516 can be positioned proximal to the incision / orifice and rolled. The shield 510 is inserted by compressing one or more of the rings 512, 516. Both rings 512, 516 can be compressed to a low profile configuration for easy insertion through the incision, but generally only the distal ring needs to be compressed, not necessarily the proximal ring, which is external to the patient. Also, since the distal ring is internal to the patient, only the proximal ring needs to be configured to roll the sidewall 520. One or more of the rings 512, 516 configured to roll can be rolled in opposite directions to increase the length of the sidewall 520. When one of the rings 512, 516 is rolled, the length of the sidewall 520 is wound onto the ring, shortening the length of the shield 510. The elongated cross-section of the ring advantageously keeps the sidewall 520 rolled up on the ring. If the cross-section were circular, the ring could more easily roll in situ, thereby causing the rolled-up sidewall 520 to unravel.Rolling the ring on itself draws the opposing ring upward and closer.

[0084] The rings 512, 516 are formed from a single elongated piece of plastic and formed into a circle or other shape by joining the free ends together. In another variation, the rings 512, 516 are made of two or more pieces, such as two semicircles, that together define a circle of the same radius. The ends are not connected but are held in a normal curved configuration. The multi-piece ring makes it easier to compress the ring into a smaller configuration. The ring is approximately 0.38 inches high and 0.18 wide, and is approximately 38 inches long. The thickness of the material forming the ring 314 is approximately 0.18 inches. FIG. 65 shows the shield 510 being placed inside the bag 310 and the proximally located first ring 512 being retracted by rolling until the proximal rigid ring 512 is flush with the outer surface of the patient's abdomen. The cut-resistant material of the rings 512, 516 as well as the sidewall 520 protect the bag 310. Retraction by rolling the proximal first ring 512 advantageously stretches the incision. The resulting larger incision allows for easier 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 the sidewalls of the shield 510 are made of a protective material.

[0085] 66-67, there is shown another shield 510 in accordance with the present invention. The shield 510 is similar to the shield of FIGS. 64-65 in that it includes a first ring 512 at a proximal end 514 and a second ring 516 at a distal end 518 interconnected by a flexible sidewall 520. The sidewall 520 of the variation shown in FIGS. 66-67 includes a first layer 522 and a second layer 524, which are shown separated and laid flat in FIG. 67. The first layer 522 includes a plurality of longitudinal slits 526 and the second layer 524 includes a plurality of longitudinal slits 528. The first layer 522 is placed adjacent or juxtaposed with the second layer 524 to form a lantern-like sidewall 520, with the slits 526 in the first layer 522 and slits 528 in the second layer 524 offset so that the slits do not meet and cause a tear through the shield 510. Instead, the overlapping layers 522, 524, along with their offset slits 526, 2528, form a flexible yet strong, penetration-resistant sidewall 520. Each of the first layer 522 and second layer 524 is a flexible or semi-flexible sheath that easily bends yet is cut-resistant. The layers 522, 524 are flexible enough to facilitate insertion, yet are retractable when placed inside the bag in the incision, with or without flipping 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 Fig. 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, and the sidewalls 520 are made of a protective material.

[0086] 68-70, another variation of a shield 530 according to the present invention is shown. The shield 530 is made of a flexible or semi-rigid plastic. The shield 530 includes a flange 532, which is substantially planar and includes an opening 534 in the center. From the opening 534, a plurality of slits 536 extend outwardly from the circumference of the opening 534 into the flange 532 to enhance flexibility at the corner intersection. The flange 532 is sized and configured to fit within a retractor when in use. Specifically, the flange 532 snaps under the top ring of the retractor to help hold the shield 530 in place.

[0087] The flange 532 is connected to a central tube section 538. The tube section 538 includes a central lumen extending between a proximal opening 534 and a distal opening 540. The tube section 538 may also include a plurality of slits 542 extending upwardly from the distal opening 540. The shield 530 further includes two fingers, or extensions 544, which extend downwardly from the tube section 538 at an oblique angle that defines a first configuration of the fingers 544. The fingers 544 include a second configuration, which is a reduced or compressed configuration as shown in FIG. 69, where the fingers 544 are pressed or folded together toward the longitudinal axis to assume a lateral dimension that is the same size or smaller than the lateral dimension of the central tube section 538. The reduced configuration facilitates insertion of the shield 530 into an incision or orifice. When inserted through the abdominal wall as shown in FIG. 70, the fingers 544 are advantageously configured to spring back into a first configuration in which the fingers 544 splay outward at a predetermined angle. In this first configuration, within the incision, the fingers 544 advantageously retract not only the tissue but also the bag (not shown) into which it is inserted. The slits 542 provide additional flexibility to the distal end of the central portion 538, allowing it to assume a narrower configuration when placed within the incision and then snap back to its normal configuration which aids in the retraction of the bag and tissue. The height of the flanges 532 and central portion 538 is approximately 0.5-2.0 inches, and the shield 530 is made of HDPE, LDPE, HYTREL®, or other suitable polymers or metals. The shield 530 can also include more than two fingers 544.

[0088] 87-90, there is shown a morcellation system 600. The morcellation system 600 is a device that allows for the removal of large amounts of body tissue or organs in a safe manner through a limited surgical opening. The morcellation system 600 is a substantially closed system that prevents contamination of surrounding tissue with potential cancer cells that may be 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.

[0089] The containment bag may be any of the bag embodiments described herein. In general, the containment bag includes a polymeric pouch having a mouth or opening attached to a ring that surrounds the mouth opening. The ring is flexible and configured to be biased to an open configuration such that the mouth of the bag is held open by the ring, facilitating insertion of a specimen into the bag. The ring is flexible and configured to be compressed to a low profile state that allows for easy insertion into a wound or orifice. The ring maintains the opening and also allows the bag to be retracted by rolling the ring around itself and wrapping the side walls of the bag around the ring. A tether is attached to the ring or to the proximal end of the bag. The tether includes an attachment tag for grasping with a surgical instrument.

[0090] The morcellation system 600 further includes a morcellator 602. The morcellator 602 is a powered morcellator. The morcellator 602 includes a cutting ring or annular blade 610 having a sharp distal end adapted to sever tissue. The annular blade 610 is mounted in a hollow cylinder 612. The cylinder 612 is connected via gears to a pneumatic or electric motor (not shown) and configured to rotate about a longitudinal axis. The morcellator 602 includes an inner cylinder 614 having a flared or funnel-like proximal end connected to a morcellator housing 616. A distal end 620 of the inner cylinder 614 extends to a location proximal to the annular blade 610. The inner cylinder 614 defines a working channel or central lumen 618 of the morcellator 602. The inner cylinder 614 prevents tissue drawn into the central lumen 618 from spilling into the morcellator 602. The morcellator 602 further includes an outer cylinder 622. The outer cylinder 622 coaxially surrounds the cutting cylinder 612. The outer cylinder 622 has a proximal end that is connected to or forms a part of the housing 616. A distal end 624 of the outer cylinder extends to a location proximal to the distal end of the blade 610. The outer cylinder 622 includes an extension 626 at the distal end 624 of the outer cylinder 622. The extension 626 extends slightly beyond the distal end of the blade 610. The extension 626 prevents coring of the specimen being morcellated.

[0091] The morcellation system 600 further includes a shield 608. The shield 608 may be any shield 608 described herein, and in one variation is as described with respect to FIGS. 51-53 and 71-86. The shield 608 has a generally spiral shape when in a longitudinally expanded configuration. The shield 608 can be collapsed into a low profile unexpanded configuration. The shield 608 can be moved from the expanded configuration to the unexpanded configuration and vice versa repeatedly as needed. The shield 608 is a flexible plastic band having a spiral shape in the expanded configuration. The shield 608 can also be made of a thin flexible 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 overall length 638 of the shield 608 during the unexpanded or low-profile configuration. The shield 608 has an inner surface 632 and an outer surface 634 interconnected by the proximal end 628 and the distal end 634 and by first and second ends. The outer surface 634 is concave and the inner surface 632 forms a convex conforming surface when viewed from within the shield 608. The outer surface 634 is substantially parallel to the inner surface 632. The shield 608 defines a central lumen 636. When in the low-profile unexpanded configuration, the shield 608 can laterally reduce in size to have a relatively small lateral dimension. As described above, the shield 608 includes a relaxed normal position having a first lateral or diametric dimension during the low-profile unexpanded configuration. The shield 608 also includes a reduced configuration having a second lateral or diametric dimension during the low-profile unexpanded configuration. The second lateral or diametric dimension is smaller than the first lateral or diametric dimension. The contracted configuration when in the unexpanded configuration is achieved by curling the shield 608 on itself into a tighter, smaller configuration. The curling action reduces the size of the central lumen 636. This contracted configuration can be held fixed by hand or by a lock.Insertion of the shield 608 into a small incision or orifice is greatly facilitated by curling the shield 608 on itself into a contracted configuration. Once inserted into the incision or orifice, the shield 608 is then released and allowed to unroll from the tight curl into a relaxed normal position having a larger transverse dimension. However, forces from the surrounding tissue may prevent the shield 608 from reaching the first transverse or diametric dimension, and thus the shield 608 may reach a dimension equal to or equal to the second transverse dimension, or may have a dimension somewhere between the first and second transverse dimensions. Additionally, the shield 608 may be anchored into an expanded configuration having a third transverse or diametric dimension. The third transverse or diametric dimension is greater than the first transverse or diametric dimension. The expanded configuration may be locked into place by any of the locks described herein that secure the position and transverse or diametric dimensions of the shield 608. The expanded configuration can serve to retract tissue and enlarge the orifice or wound opening. The contracted configuration as well as the relaxed normal configuration and any position between the contracted and enlarged configurations can serve to retract tissue and hold open wounds and orifices while providing a working channel through the central lumen 636.

[0092] 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 cylinder 612, the inner cylinder 614, and the outer cylinder 622, which extend 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 protruding from the outer cylinder 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 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, length 638 of shield 608 extends slightly distally beyond blade 610. In another variation, length 638 of shield 608 is distal to extension 626. Length 638 of shield 608 is adapted to encircle the depending portion of morcellator 602, and in particular blade 610. By encircling blade 610, shield 608 guards blade 610 from inadvertently contacting surrounding tissue and the containment bag.

[0093] In use, the tissue containment bag is placed through a small abdominal incision or a small orifice or opening in the body. This is accomplished by compressing the flexible ring of the bag into a low profile configuration and inserting the bag through the small incision / opening. The flexible ring is allowed to spring open inside the body cavity, expanding the mouth of the bag to facilitate placement of the severed piece of target tissue into the bag. The target tissue is placed into the bag while it is inside the abdominal body cavity. A retractor may be used and placed inside the incision. A tether on the bag is then used to pull the ring of the bag through the incision. The ring on the bag is rolled on itself, causing the side walls of the bag to roll around the ring, reducing the length and size of the bag, thereby drawing the specimen inside the bag closer to the incision / opening. The specimen inside the bag is viewed with the naked eye near the mouth of the bag. The shield 608 is rotated while outside the patient to minimize size by rolling or curling the shield 608 on itself into a tighter configuration. While in the contracted configuration, the shield 608 is placed in a bag within the incision / opening and allowed to expand on itself or diametrically expand to maximize the incision opening by reversing the rotation of the shield 608. The expanded position can be secured with a lock of the type described herein. The shield 608 is anchored to its larger size. The C-shaped outer surface 634 of the shield 608 is anchored snugly within the incision such that the abdominal wall sits within the concave surface of the "C". The tenaculum 606 is advanced through the central lumen 618 of the morcellator 602 and used to grasp the target tissue while it is visualized with the naked eye. Once the tissue is properly grasped, it is held by the tenacious barb 606 and the morcellator 602 is moved or slid down the length of the tenacious barb 606 until the depending portion of the morcellator 602, including the blade cylinder 612, the inner cylinder 614 and the outer cylinder 622, passes through the central lumen 636 of the shield 608 and the distal end of the morcellator housing 616 abuts the proximal end 628 of the shield 608. The tenacious barb 606 can be pulled proximally to bring the specimen into contact with the blade 610 of the morcellator 602.The morcellator 602 is started to rotate the blade cylinder 612 at high speed. The tenaculum is retracted proximally while still gripping the specimen. The tenaculum is used to pull the gripped tissue into the cutting blade of the morcellator 602. The extension 626 of the outer cylinder 622 prevents the entire circumference of the blade 610 from cutting through the tissue at the same time. This prevents coring and allows the blade 610 to move along the specimen, resulting in a larger specimen portion being extracted in one piece. After all of the tissue has been removed or reduced to a piece that has a size that can pass through the incision, the shield 608 and bag are removed. The shield 608 advantageously protects and retracts adjacent tissue at the incision and cards adjacent portions of the containment bag from accidentally contacting the cutting blade 610. The present invention also avoids creating a secondary opening in the containment bag to insert a scope to visualize the morcellation procedure. Secondary openings that can compromise a closed containment system are advantageously avoided by the morcellation system 600. Morcellation within a body cavity can disperse potentially harmful fragments of the specimen being morcellated. Morcellation within a closed system is therefore desirable. Placing the specimen within a containment bag creates a closed system when the opening of the bag is brought to the surface through the incision, thereby isolating the specimen within the bag and isolating it from contact with tissue within the body cavity. Previous solutions for visualization required creating a separate opening in the bag and placing the laparoscope through that opening, whereby the closed system is no longer maintained. Alternatively, the scope may be placed through the same incision as the morcellator, which results in poor visibility and triangulation capabilities necessary for optimal viewing. The shield 608 advantageously allows cutting mechanisms, including a powered morcellator, to be used within a closed system while preventing a potential breach of the closed system. The morcellation system 600 allows visualization of the specimen without a laparoscope by bringing the specimen to the surface as the bag is retracted.The morcellation system 600 maintains and ensures a closed system throughout the morcellation procedure by mitigating damage to the tissue containment bag through the use of a 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 is located between the bag and the morcellator 602. The shield 608 holds open the incision opening for easy visualization and removal of the specimen. The shield 608 protects the bag and tissue from damage by the cutting blade 610 or tenaculum 606 at the incision site. The outer cylinder 622 of the morcellator is surrounded by the shield 608, which prevents accidental contact between the blade 610 and the containment bag, which could result in breaching the closed system. The shield 608 forms a protective cage around the blade to ensure safe morcellation. In one variation, the length 638 of the shield 608 in the unexpanded configuration is approximately 1 inch, and the length 640 of the morcellator cylinder is also approximately 1 inch.

[0094] 89-90, a morcellation system 600 is shown that uses an energy based morcellator 602. The energy based morcellation system utilizes a tissue containment bag, tenaciton, and shield 608 in the same manner as described above. Rather than rotating the blade 610 to cut the tissue, the circular blade 610 remains stationary. The blade 610 and cylinder 612 of the morcellator 602 are connected to a monopolar energy system 652 via an energy input 650. The tenaciton 606 is connected to a plug 654 that leads to a ground on the monopolar energy system 652. When the target tissue is grasped by the tenaciton 606 and brought to the blade 610, the monopolar energy is activated to cut the tissue. The extension 626 serves the same purpose as described above. An exhaust port 656 is provided on the housing 616 to prevent inhalation of fumes from the cutting process.

[0095] 91-103, a shield 700 adapted for placement within the vaginal canal is shown. The shield 700 has a configuration similar to the shields described herein. The shield 700 is substantially cylindrical / tubular formed from a band of material having an inner first end 702 and an outer second end 704 interconnected between a proximal end 706 and a distal end 708. The shield 700 includes an outer surface 710 and an inner surface 712. The inner surface 712 defines a central lumen 714 extending along a longitudinal axis from the proximal end 706 to the distal end 708. The central lumen 714 is shown in a circular shape, and in another variation can have an elliptical or elongated oval oval shape. The proximal end 706 defines a radially outwardly extending proximal flange 716 that forms a funnel-like entrance to the central lumen 714. The outer surface 634 is concave and gradually flares radially outward toward the distal end 708. In another variation, the distal end 708 is not flared, but is generally cylindrical with a substantially constant diameter distal to the funnel-like flange 716 at the proximal end. At least a portion of the shield 700 overlaps upon itself when in the relaxed resting configuration. In another variation, the shield 700 does not overlap upon itself when in the relaxed configuration. The shield 700 can curl upon itself to reduce its transverse diameter to facilitate insertion into a vagina or other orifice or wound incision. The overlapping portions of the shield 700 nest relative to one another. The shield 700 is configured such that one end, e.g., the first end 702, slides relative to the second end 704. The shield 700 can have a first reduced transverse 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 tighter, smaller configuration. The shield 700 also includes a relaxed normal position having a second lateral or diametric dimension. The second lateral or diametric dimension is greater than the first lateral / diametric dimension.The shield 700 is shaped to have a bias toward a normal relaxed position, and when contracted to a first diametric position, the shield 700 tends to automatically expand or spring open or anchor toward its relaxed normal position having approximately a second lateral or diametric dimension. The shield 700 can be provided with a lock of the type described herein that fixes the lateral or diametric position. The shield 700 also includes an expanded configuration having a third lateral or diametric dimension. The third lateral or diametric dimension is greater than the second lateral or diametric dimension. The expanded configuration is achieved by curling the shield 700 in the opposite direction or anchoring the shield 700 to open the central lumen 714. Any of these positions and any intermediate positions of the lateral dimension of the shield 700 can be locked into place via a lock. The shield 700, and particularly the expanded configuration of the shield 700, serves to retract tissue and open an orifice or wound to provide a safe working channel for the surgical procedure.

[0096] As can be seen in FIGS. 93-94, the first end 702 and the second end 704 each have an S-shaped curvature that overlies the outer surface 710 of the adjacent shield portion. The S-shape transitions into notches 718, 720 near the proximal and distal ends 706, 708, respectively. The notches 718, 720 form locks configured to secure the lateral dimension of the shield 700. The notches 718, 720 are shown in FIGS. 93-94 in an unlocked position and in FIGS. 97-98 in a locked position. The notches 718, 720 form finger-like extensions that fit together to lock the shield 700 in place. In FIGS. 97-98, the finger-like extensions near the notches 718 of the outer second end 704 overlie the inner first end 702 to lock the shield 700 in place. As mentioned above, the outer surface 710 of the shield 700 forms a concave surface with an inflection point 722 seen in FIGS. 93-94. The inflection point 722 is located above a mid-plane taken perpendicular to the long axis near the proximal flange 716. The proximal flange 716 acts as a protective surface to guard the containment bag, retractor 724 and vaginal canal tissue in the insertion position. The shield and / or flanges are made of 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 cutting board-like surface against which a sharp object such as a scalpel or blade can be advantageously used to cut and reduce the targeted tissue without fear of cutting the containment bag, adjacent tissue or retractor.

[0097] 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 respect to FIGS. 18-19. The retractor 724 includes a first ring 726 and a second ring 728 interconnected 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 abut the vagina and form an anchor. The first ring 726 resides outside the patient over the entrance to the vagina where it can be rolled down to retract and widen the vaginal canal.

[0098] In a hysterectomy, the uterus is detached from the body by instruments inserted through an abdominal port. After the uterus is detached, the shield 700 can be inserted directly into the vaginal canal. In such a variation, the shield 700 curls on itself into a contracted configuration to aid in the insertion of the shield 700, and when in place, the shield 700 expands to its normal relaxed configuration while inside the vaginal canal, thereby dilating and retracting the vaginal opening. The proximal flange 716 is near the entrance to the vagina. The detached uterus can be grasped and pulled into the central lumen 714 of the shield 700, and the blades can morcellate the uterus against the shield, reducing its size or breaking it into pieces that can be removed completely through the vaginal canal.

[0099] In another variation, the containment bag can be placed inside the abdominal cavity either through an abdominal port or through the vaginal canal. The removed uterus is placed inside the containment bag. The containment bag tether is pulled through the vaginal canal. The containment bag ring is compressed into a low profile configuration to facilitate pulling the proximal end of the containment bag through the vaginal canal. The containment bag ring is pulled outside the body and expanded to an open configuration, thereby opening the mouth of the containment bag. The containment bag ring is outside the vaginal introitus. The containment bag ring can be rolled down and the bag side walls can be rolled over the containment bag ring. This action brings the removed uterus inside the bag near the vaginal opening. The shield 700 is then inserted into the mouth of the containment bag and into the vaginal canal. The shield 700 can be curled into a compact configuration to aid in insertion. The proximal flange 716 is at or near the vaginal introitus. In one variation, the proximal flange 716 of the shield 700 snaps under the ring of the containment bag. The removed uterus is grasped with a grasper and drawn into the central lumen 714 of the shield 700 where morcellation can begin.

[0100] 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 morcellated with the blade while at least partially within shield 700 before being completely removed in whole or in portions. Shield 700 advantageously protects the surrounding vaginal canal as well as the containment bag from the sharp blade and helps maintain the integrity of the containment bag and closed morcellation system.

[0101] In another variation, the same procedure is performed as in the previous paragraph, but the retractor 724 is inserted into the mouth of the containment bag after placing the uterus in the containment bag and after the ring of the containment bag is withdrawn outside the body. The second ring 728 of the retractor 724 is compressed for easy insertion into the mouth of the containment bag, and then expanded to an open configuration inside the containment bag at a distal location of the vaginal canal inside the abdominal cavity. The first ring 726 of the retractor 724, which is outside the body, is rolled around itself, rolling the side wall 720 of the retractor 724 onto the first ring 726. This action not only retracts the vaginal canal, but also retracts the containment bag out of the way, clearing the vaginal canal for insertion of the shield 700. The containment bag is captured between the retractor and the vaginal canal, keeping it in place and preventing it from migrating in or out of the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724 inside the containment bag. The shield 700 can be curled down into a compact configuration if necessary and then expanded to self-anchore the shield 700 in place. The shield 700 is then connected to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726, as shown in FIGS. 99-103. The uterus can then be grasped with surgical instruments and pulled from the pouch of the containment bag into the central lumen 714 of the shield 700 where it is morcellated with the blade while at least partially within the shield 700 before being completely removed in whole or in part. The shield 700 advantageously protects the surrounding vaginal canal as well as the containment bag from the sharp blade, helping to maintain the integrity of the containment bag and the closed morcellation system, while providing the surgeon with a mechanism for performing the morcellation safely and quickly.

[0102] In another variation, the same procedure is performed as in the previous paragraph, except that the retractor 724 is placed in the vaginal canal before pulling the containment bag with the specimen therein through the vaginal canal. In this variation, the removed uterus is placed inside the containment bag located inside the body cavity, and a tether attached to the proximal end of the containment bag is pulled by a grasper through the central lumen of the retractor to bring the ring and mouth of the containment bag to the outside of the patient. The ring of the containment bag can then be rolled down to bring the peeled uterus near the opening. The flexible retractor 700 is then curled on itself to reduce the size in the direction of the shield 700 to a compact configuration, and then the shield 700 is released and allowed to expand with its bias urging it to expand laterally from the compact configuration. As the shield 700 expands, it self-anchores and retracts the containment bag to create a working channel through the central lumen 714 of the shield 700 for movement and morcellation of the peeled uterus. The proximal flange 716 of the shield 700 can snap under the ring of the containment bag or the first ring 726 of the retractor 724. The containment bag is captured between the retractor 724 and the shield 700, keeping it from sliding proximally or distally during the procedure. The flange 726 can also act as a cutting board-like surface against which a sharp blade can be used to cut the uterus for 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 combinations.

[0103] In yet another variation, the shield 700 is used with a retractor 724 as shown in Figures 99-103. In such a variation, the retractor 724 is placed in the vaginal canal. The uterus is separated using standard techniques before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed for easy insertion into the vaginal canal and then expanded to an open configuration at a distal location of the vaginal canal inside the abdominal cavity. The first ring 726 of the retractor 724, which is outside the body, is rolled around itself to roll the side walls 720 of the retractor 724 over 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 down into a compact configuration if necessary and then expanded to self-anchore the shield 700 in place. The shield 700 is then connected to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726, as shown in Figures 99-103. The uterus can then be grasped with a surgical instrument and drawn into the central lumen 714 of the shield 700, where it is morcellated with a blade while at least partially within the shield 700, before being completely removed in whole or in sections. The shield 700 advantageously protects the surrounding vaginal canal as well as the retractor 724 from the sharp blade, while providing the surgeon with a mechanism for performing the morcellation safely and quickly.

[0104] 104-107, another variation of a shield 800 adapted for use in the vaginal canal is shown. The shield 800 includes a top end 802 and a bottom end 804 interconnected by a sidewall 806. An opening 808 is formed in the shield 800, which extends through the top end 802 and the bottom end 804. The shield 800 further includes 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 includes 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 includes a hook 818 that is configured to be attached to a ring of a storage bag or a proximal ring of a retractor by snapping under the ring. FIGS. 106-107 show the shield 800 connected to a retractor 724. The retractor 724 is the same retractor described above with respect to FIGS. 18-19 and 99-103. The retractor 724 includes a first ring 726 and a second ring 728 interconnected by a flexible sidewall 730. The sidewall 730 defines a central opening that extends 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 abut the vagina and form an anchor. The first ring 726 is external to the patient and over the entrance to the vagina where it can be rolled down to retract and widen the vaginal canal.

[0105] Although shield 800 is described herein for use during a surgical procedure such as a hysterectomy, the invention is not limited to use in hysterectomies and may be applied to any target tissue removal and morcellation procedure, in which the uterus is separated from the body by instruments inserted through an abdominal port.

[0106] In one variation, the shield 800 is used with a retractor 724 as shown in FIGS. 106-107. In such a variation, the retractor 724 is placed in the vaginal canal. The uterus is released using standard techniques before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed for easy insertion into the vaginal canal and then expanded to an open configuration at a distal location of the vaginal canal inside the abdominal cavity. The first ring 726 of the retractor 724 remains outside the body and rolls around itself, rolling the side wall 720 of the retractor 724 over the first ring 726. This action retracts the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 and connected to the retractor 724. The shield 800 is connected to the first ring 726 of the retractor 724 by snapping the second flange 812 of the shield 800 under the first ring 726 from within the first ring 726, as shown in FIGS. 106-107. Additional hooks can be provided to connect the shield 800 to the retractor 724. The shield 800 covers or caps over the first ring 726 of the retractor 724, and one or more hooks 818 are hooked under the first ring 726 to secure the shield 800 to the retractor 724. The uterus can then be grasped with a surgical instrument and pulled proximally to position it on or apposed to the first flange 810. The first flange 810 of the shield 800 is curved to advantageously cradle the dissected uterus and prevent it from slipping off the first flange 810 while the surgeon uses a blade to cut and reduce the size of the uterus for removal through the vaginal canal. The first flange 810 advantageously serves as a cutting board-like surface against which the blade can be safely used to cut tissue that rests near or against the first flange 810. The angled distal end 814 of the first flange 810 provides additional vaginal dilation and provides a ramp to move and guide the uterus proximally into the vaginal canal and toward the vaginal opening.At the proximal end of shield 800, a ring-like portion of shield 800 advantageously retracts the labia to safely move out of the path of the morcellation blade. The uterus is morcellated with the blade while at least partially within shield 800, before being completely removed in whole or in sections. Shield 800 advantageously protects the surrounding vaginal canal, labia, and retractor 724 from the sharp blade, while providing the surgeon with a mechanism for performing the morcellation safely and quickly.

[0107] In another variation, the containment bag can be placed inside the abdominal cavity either through an abdominal port or through the vaginal canal. The removed uterus is placed inside the containment bag. The containment bag tether is pulled through the vaginal canal. The containment bag ring is compressed to a low profile configuration to facilitate pulling the proximal end of the containment bag. The containment bag ring is pulled outside the body, expanding to an open configuration and opening the containment mouth. The containment bag ring is outside the vaginal inlet. The containment bag ring can be rolled down to roll the bag side walls over the containment bag ring. This action brings the removed uterus inside the bag close to the vaginal opening. The shield 800 is then inserted into the containment bag mouth and into the vaginal canal, and the second flange 812 hooks onto the ring and connects to the containment bag ring, securing the shield 800 to the bag. The removed uterus inside the bag is grasped with a grasper and pulled over the first flange 810 of the shield 800. The angled distal end 814 of the first flange 810 helps guide and tilt the uterus into position and cradles it for morcellation. The uterus is morcellated with the blade while at least partially adjacent the first flange 810 before being completely removed, either in whole or in sections. The shield 800 advantageously protects the surrounding vaginal canal as well as the containment bag from the sharp blade and helps maintain the integrity of the containment bag and closed morcellation system.

[0108] In another variation, the same procedure is performed as in the previous paragraph, but the retractor 724 is inserted into the mouth of the containment bag after placing the uterus in the containment bag and after the ring of the containment bag is withdrawn from the body. The second ring 728 of the retractor 724 is compressed for easy insertion into the mouth of the containment bag, and then expanded to an open configuration inside the containment bag at a distal location of the vaginal canal inside the abdominal cavity. The first ring 726 of the retractor 724 is rolled around itself, rolling the side wall 720 of the retractor 724 onto the first ring 726. This action not only retracts the vaginal canal, but also retracts the containment bag out of the way, clearing the vaginal canal for insertion of the shield 800. The containment bag is thereby captured between the retractor 724 and the vaginal canal, keeping it in place and preventing it from moving proximally or distally along the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 inside the containment bag. The shield 800 is then connected to the first ring 726 of the retractor 724 by snapping the second flange 812 of the shield 800 under the first ring 726 of the retractor 724. The uterus can then be grasped with a surgical instrument and pulled from the pouch of the containment bag into apposition to the first flange 810 of the shield 800, where it is morcellated with a blade while at least partially in contact with the first flange 810 before being completely removed in whole or in portions. The shield 800 advantageously protects the surrounding vaginal canal and the containment bag and retractor 724 from the sharp blade, helping to maintain the integrity of the containment bag and closed morcellation system, while providing the surgeon with a mechanism to perform the morcellation safely and quickly. 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 combinations. It will also be appreciated that the present invention is not limited to hysterectomy procedures, but may be applied to the morcellation, reduction and removal of any tissue or organ.

[0109] 108-109, a variation of a shield 900 is shown that includes a funnel 902 with retracting fingers 904 at its distal end. The funnel 902 defines a central opening 906. The proximal end of the shield 900 defines a funnel-like entrance to the central opening and forms a proximal flange surface that circumferentially surrounds the central opening 906. The shield 900 is inserted into an orifice or wound incision by first inserting the retracting fingers 904 and then inserting or angling the central portion of the funnel 902 into the opening. The proximal end of the funnel 902 is placed over the abdomen or other external body surface. The proximal flange provides a cutting board position against which tissue can be morcellated. The retracting fingers 904 serve to retract the incision or orifice and help keep the shield 900 anchored in place. The retraction fingers 904 form a distal flange that extends around only a portion of the circumference distal to the central opening 906. The retraction fingers 904 are curved such that the side profile of the shield 900 at the location of the retraction fingers 904 is substantially C-shaped, with the top of the "C" extending laterally a greater distance than the bottom of the "C". The funnel 902 also provides protection to surrounding tissue and a containment bag, as well as a retractor when used with the shield 900. For example, a containment bag can be inserted through an orifice or incision, and after the specimen is inserted into the bag, the mouth of the bag is pulled back through the incision. The proximal end of the bag is placed over the abdomen, and the shield 900 is inserted into the mouth of the bag and anchored by the retraction fingers 904. A grasper is inserted into the central opening 906, and the specimen inside the bag is pulled toward the central opening 906. The blade is then used to reduce the specimen for whole or section removal through a small incision / orifice. The shield 900 is made of a rigid plastic of sufficient thickness to reduce the chance of penetration by the blade, protect adjacent tissue, and maintain the integrity of the containment bag.

[0110] In another variation, the shield 900 is used with a retractor similar to that described above. The retractor is placed inside the incision either before or after placing the bag, and then the shield 900 is inserted into the mouth of the bag and retractor. In one variation, the proximal end of the shield 900 is sized and configured to mate with the proximal ring of the retractor or bag by capping or snapping onto the proximal ring of the bag or retractor. A variation of the shield 900 adapted to cap onto the proximal ring of the retractor or bag is shown in FIGS. 109B and 109C and has 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 or clamp configured to attach to the ring of the retractor or bag.

[0111] 109, the funnel 902 includes a circumferential rim 908 rising from an inner surface. The rim 908 is configured to connect with the blades, as described in more detail below. The funnel 902 also includes 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 similar to the shields described with respect to FIGS. 71-86 as well as other shields described herein. In one variation, the second shield 912 is spiral-shaped and longitudinally collapsible and expandable as described above. In the variation shown in FIG. 110, the second shield 912 is not spiral-shaped, but is substantially cylindrical, has a concave outer surface and a gap 914, forming a C-shaped shield. The second shield 912 includes a proximal flange 916 and a distal flange 918 interconnected by a central portion 920. The proximal flange 916 may include a tab or finger pull to aid in its removal from the orifice / incision. The second shield 912 has a contracted configuration that is smaller in lateral dimension than the normal relaxed configuration shown in FIG. 110. The contracted configuration is optimal for insertion into a wound or orifice and for connecting the second shield 912 to the first shield 900. The second shield 912 is made of a flexible plastic that has sufficient properties to prevent penetration by a blade or other sharp object or instrument under normal use to protect adjacent tissue.

[0112] 111, there is shown a first shield 900 connected to a second shield 912. The C-shaped second shield 912 is disposed inside the first shield 900 such that a proximal flange 916 of the second shield 912 overlaps 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 connection with the raised portion 910 prevents the second shield 912 from moving around inside the funnel 902. The first shield 900 provides protection along a portion of the lower circumference at the retracting finger 904, and the second shield 912 completes the circumferential protection at the distal end. The second shield 912 provides 360 degrees of circumferential protection at the distal end disposed within the incision / orifice. The distal flange 918 also provides a funnel-like entrance to the central lumen 922 of the second shield 912, which aids in moving tissue into the shield 900, 912 and out of the body while providing protection to surrounding tissue, a containment bag, and a retractor if used. The shields 900, 912 can be used with manual blade morcellation or with a short powered morcellator similar to that described above with respect to Figures 87-90.

[0113] 112-113, there is shown a blade carrier 926 that is connected to a first shield 900 and then to a second shield 912 to form another variation of the shield system. The blade carrier 926 includes a funnel 928 that defines a central opening 930, a blade receiver 932, and a blade 934. The funnel 928 includes a funnel-like shape and a circumferential hook configured to cap, snap-fit ​​to, and connect to the first shield 900. Specifically, as shown in FIG. 113, the circumferential hook of the funnel 928 connects directly to the raised circumferential rim 908. In one variation, the blade carrier 926 is snap-fit ​​to the first shield 900 such that it is held vertically while still being allowed to rotate relative to the first shield 900. The blade receiver 932 receives the blade 934 within a blade channel 936. The blade 934 is connected to the blade handle 938 via a pin 940 that connects the blade 934 to the inner rod 942. Details of the blade housing 932 are also shown in Figs. 114-115. In one variation, the inner rod 942 to which the blade 934 is pinned via the pin 940 reciprocates relative to the blade handle 938. The reciprocating motion can be provided by manually moving the inner rod 942 back and forth at the proximal end relative to the blade handle 938 to cause back and forth motion of the blade 934 at the distal end. The reciprocating motion can be provided by an electric motor (not shown) located in the blade handle 938 at the proximal end in a removable and reusable handle attachment. The blade receiver 932 can be provided in two pieces, a first part and a second part. The first part includes a blade channel 936 having a slot 944 configured to receive the pin 940 and configured to guide the translation of the blade 934 within the blade channel 936. One end of the pin 940 is connected to the blade 934 and the other end of the pin 940 is connected to a distal end of an inner rod 942 housed in a second portion of the blade receiver 932 which together house the blade 934 .The blade receiver 932 is connected to a funnel 928 of the blade carrier 926. The inner rod 942 moves distally to expose the blade 934 for cutting tissue when in the exposed position. Once the blade 934 is exposed, the blade carrier 926 can rotate relative to the first shield 900 to circumferentially cut tissue along at least a portion of the interior of the central lumen. The blade 934 can be retracted to a retracted position where the blade 934 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, 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 for cutting tissue. The reciprocating cutting motion can be selectively actuated manually or automatically by a user when tissue cutting is desired, or can be actuated to continuously reciprocate. Also, the reciprocating cutting motion can occur simultaneously with the rotation of the blade carrier 926 relative to the first shield 900, or can occur intermittently relative to the rotation of the blade carrier 926. Moving the blade 934 from the retracted position to the exposed position moves the blade 934 in a plane that includes the distal end of the central opening 930, at an angle to that plane, or substantially perpendicular to that plane. This plane can also be defined as a plane perpendicular to the long axis of the device or the long axis of the central lumen. The amount of the blade 934 exposed can be selected by the user, and selective cutting is performed. For example, the blade 934 can be only half exposed from a fully retracted position, in which case the blade 934 can not intersect with a plane that includes the distal end of the central opening 930. The blade 934 is configured to extend beyond the distal end of the central opening 930 of the blade carrier 926 but not beyond the distal end of the second shield 912, thereby ensuring that the blade 934 and its passageway are always surrounded and enclosed by any one or more of the first shield 900, the second shield 912, and the blade carrier 926. In another variation, the distal end of the blade 934 is allowed to extend slightly beyond the distal end of the second shield 912.

[0114] In one variation, the blade 934 is fixed relative to the blade receiver 932 and does not reciprocate relative to the blade carrier 926, but only rotates relative to the first shield 900. In another variation, 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 934 is configured to reciprocate relative to the blade carrier 926. The rotational cutting action is intended to ensure protection of the surrounding tissue while increasing the chances that the specimen will be removed as a single excision instead of multiple pieces. Also, the blade 934 is depicted in the drawings as curving downward to enter the central opening. In another variation, the blade 934 extends radially inward in a plane perpendicular to the central lumen, having a configuration similar to a guillotine or cigar cutter. It is within the scope of the present invention for the blade 934 to have an approach angle of 0 degrees to 180 degrees, where a zero degree approach angle is where the blade 934 intersects a plane perpendicular to the long axis of the central lumen at the 12 o'clock position, parallel to the long axis. An approach angle of less than 180 degrees is where the blade 934 intersects a plane perpendicular to the long axis from below the plane at approximately the 5 to 7 o'clock position.

[0115] 116 shows the blade 934 of the blade carrier 926. The blade 934 has a sharp tip and sharp sides configured to pierce and cut tissue.

[0116] 117-119, there is shown a shield assembly 950 including a blade carrier 926, a first shield 900, and a second shield 912. A blade 934 is shown connected to a blade handle 938 having a motor housed within a removable handle extension 946. The first shield 900 includes a cutout 948, which can be seen in FIGS. 109, 111, 117, and 118. The cutout 948 facilitates separation and removal of the blade carrier 926 from the first shield 900 by providing a place for a finger to click the blade carrier 926 away from the first shield 900.

[0117] 120-126, another variation of the shield assembly is shown. The shield assembly includes a first shield 900, a second shield 912, and a blade carrier 926. The blade carrier 926 includes a blade receiver in two parts 932a, 932b, a blade 934, an inner rod 942, a pin 940, and a blade handle 938. The length of the blade handle 938 is not shown to scale and is depicted for illustrative purposes, including a variation in which a reusable handle extension 946 can be attached to the proximal end of the blade handle 938 in a configuration in which the shield assembly is disposable. The variation of FIGS. 120-126 is substantially similar to the variation shown in FIGS. 109-119, with some modifications. The second shield 912 is of the spiral nature described above instead of being of the nature of a cutting cylinder. The second shield 912 is shown in a compressed configuration in FIG. 120. The first shield 900 includes an outer rim 908 that is located around the upper periphery of the first shield 900. A funnel 928 of a blade carrier 926 snaps under the outer rim 908 in the variation shown in Figures 120-126.

[0118] In another variation of the shield, the shield is molded around a helicoid (spiral surface) whose cross section perpendicular to the helical guide path is parabolic. Once the mold is removed, the helical surface is compressed on itself into a catenoid (suspended surface) and remains in that state during its rest state. The following parametric equations cover the shield variations:

[0119] x(u,v)=β[cos(α)sinh(v)sin(u)+sin(α)cosh(v)cos(u)] (1)

[0120] y(u,v)=γ[-cos(α)sinh(v)cos(u)+sin(α)cosh(v)sin(u)] (2)

[0121] z(u,v)=δ[ucos(α)+vsin(α)] (3)

[0122] The value α is a constant fixed parameter that changes the state of the progression of the transformation from helicoid to catenoid. When α=0, a helicoid is generated, and when α=π / 2, a catenoid is generated. The shield variant has a value of α greater than 0 and less than π / 2, which can be considered as the open interval (0,π / 2). The other shield variant has a value of α greater than 0 and less than π / 2, which can be considered as the open interval (0,π / 2). The other shield variant has a value of α greater than 0 and less than π / 2, which can be considered as the open interval (0,π / 2). The parameters β, γ, δ are also fixed constants. When β,γ,δ∈R\{0}, if β<0, γ<0, δ<0, the rotation is counterclockwise. If any of β,γ,δ>0, the rotation is clockwise. The surface is constructed on the uv plane according to the parametric equations. The values ​​for vectors u and v can be thought of as u∈(-π,+π) and v∈(-∞,+∞).

[0123] 127, another variation of a storage bag 1000 according to the present invention is shown. The bag 1000 includes a sidewall 1002 that defines an opening 1004 at a proximal end. The bag 1000 has a long axis that is substantially perpendicular to the opening 1004. The sidewall 1002 can form the bag 1000 in any shape, such as cylindrical, elongated, spherical, etc., and may or may not include a base or bottom panel from which the sidewall 1002 extends toward a distal end. The sidewall 1002 can extend downward to define a base with or without a seam. For example, the bag 1000 can be formed from a long planar length of material that is folded and joined along its sides such that a seam is not formed along the base but is instead located on the side of the bag 1000 and extends upwardly substantially perpendicular to the long axis.

[0124] 127, the containment bag 1000 includes 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 is connected to the bag 1000. The first ring 1006 and the second ring 1008 are elastic and compressible from an expanded configuration, which is circular or elliptical in shape, to a collapsed elongated configuration having a reduced lateral dimension suitable for passing through a small incision, a body orifice, or through the lumen of a trocar. In one variation, the second ring 2008 is not used. The bag 1000 can be collapsed to a shorter length along the long axis of the bag 1000. The collapsed bag 1000 is then easily compressed laterally into a collapsed elongated configuration by subsequently squeezing the first ring 1006 and, if used, the second ring 1008, and deployed into the abdominal cavity. Once inside the abdominal cavity, the compressed rings 1006, 1008 can return to their original expanded open configuration. With the rings 1006, 1008 in their expanded configuration inside the abdominal cavity, the bag 1000 can be easily oriented within the abdominal cavity. Locations within the perimeter of the rings 1006, 1008 are targets for placement of resected tissue or organs. In one variation, the bag 1000 in the collapsed configuration does not have a front side to be on, since either side can be used to place specimens within the confines 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 the first ring 1006 is brightly colored or a contrasting color to the rest of the bag 1000 or intended surroundings so that it can be easily viewed laparoscopically. After the resected tissue or organ is placed within the periphery of the first ring, the first ring 1006 is moved towards the exit incision or orifice. Lifting of the ring 1006 causes the resected tissue to move or fall deeper into the interior space 1010 of the bag 1000.By moving the bag to the exit opening, the tissue sample becomes seated within the interior space 1010 of the bag 1000. The first ring 1006 is compressed into an elongated contracted configuration and is pulled through the exit orifice, opening, or exit incision. Once past the opening, the first ring 1006 expands on itself and springs back to an open expanded configuration, overlapping the exit orifice, opening, or exit incision near it, so that it resides on the abdominal wall or outside the patient. The first ring 1006 is rolled or flipped by inverting the first ring 1006 outwardly or inwardly, rolling the bag 1000 onto the first ring 1006. The first ring 1006 can be rolled in the opposite direction, unfolding the bag 1000 from the first ring 1006. In one variation, the cross section of the first ring 1006 has a length greater than its width. The elongated cross-section of the first ring 1006 advantageously keeps the side wall 1002 of the bag rolled up on the first ring 1006. If the cross-section of the first ring 1006 was circular, the first ring 1006 could be more easily rolled or unrolled to roll or unroll the side wall 1002 against the first ring 1006. The rolling of the first ring 1006 around itself pulls the bag 1000 upward, bringing the specimen inside the bag 1000 closer to the opening. The rolling motion of the first ring 1006 reduces the distance of the sidewalls 1002 between the first ring 1006 and the second ring 1008, which moves the second ring 1008 closer to the first ring 1006, the abdominal wall is anchored between the first ring 1006 and the second ring 1008, and the bag 1000 is secured to the patient to ensure morcellation. The rolling motion of the bag 1000 reduces the volume of the bag 1000 and also forms a well-formed, taut protective apron around the opening as well as the exterior of the patient around the opening. The rolling motion also serves to retract tissue at the opening, advantageously enlarging the opening and facilitating removal of tissue from within the bag 1000.The tissue specimen is then drawn from the bag 1000 by morcellating it manually with a blade or automatically with an electronic morcellator to a size and shape that allows it to pass through the opening and be removed from the bag 1000. After the tissue specimen is extracted from the bag, if necessary, the first ring 1006 is unrolled to loosen the space between the two rings 1006, 1008. The second ring 1008 is then compressed into an elongated, reduced configuration and pulled through the opening outside the patient and the bag 1000 is removed from the patient.

[0125] The bag 1000 and / or the sidewall 1002 of the bag 1000 are formed of a material that is highly cut-resistant to cutting by sharp objects such as scalpel blades and blades used in electronic morcellators. In one variation, the bag 1000 is formed of a highly cut-resistant woven material 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 variation, the bag 1000 is made of DYNEEMA® coated with an elastomer to prevent fluid from migrating to the surface of the material. In one variation, the entire bag 1000 is made of the cut-resistant material. In another variation, only selected portions of the bag 1000 are made of the cut-resistant material. In one variation, at least the portion of the sidewall 1002 of the bag 1000 located between the first ring 1006 and the second ring 1008 is made of the cut-resistant material. In another variation, only a portion of the area of ​​the bag 1000 where cutting is expected is made of a cut-resistant material. In another variation, the bottom portion of the distance between the two rings 1006, 1008 is made of a cut-resistant material, and the upper portion of the distance between the two rings 1006, 1008 is left to be rolled onto the first ring 1006. In another variation, the upper portion of the distance between the two rings 1006 is made of the same cut-resistant material, but its thickness or fiber thickness is less than the thickness of the side walls or the fiber thickness of the bottom portion. In a variation where only a portion of the bag 1000 is made of a cut-resistant material, the remaining portion is formed of a suitable polymer material as described above. In one variation, the use of the bag 1000 made of a cut-resistant material eliminates the need for the use of the retractor described above in combination with the bag 1000 in the morcellation procedure. Thus, the bag 1000 advantageously serves not only to provide cut resistance and a safety shield during morcellation, but also to retract the opening into which it is inserted. Because the bag 1000 is cut resistant, it can be used without a shield / guard of the type described above.The absence of a shield or guard advantageously provides a larger working space.

[0126] Embodiments of the bag 1000 include one or more sheets, membranes, fibers, and / or strands of material that provide the sheath with abrasion and puncture resistance in addition to cut resistance. Suitable sheets, membranes, fibers, and / or strands include at least one of natural polymers, semi-synthetic polymers, synthetic polymers, metals, ceramics, glass, carbon fibers, carbon nanotubes, and the like. Suitable natural polymers include cellulose, silk, and the like. Semi-synthetic fibers include nitrocellulose, cellulose acetate, rayon, and the like. Suitable synthetic fibers include polyesters, aromatic polyesters, polyamides (NYLON®, DACRON®), aramids (KEVLAR®), polyimides, polyolefins, polyethylenes (SPECTRA®), polyurethanes, polyureas, polyvinyl chloride (PVC), polyvinylidene chloride, polyetheramides (PEBAX®), polyetherurethanes (PELLETHANE®), polyacrylates, polyacrylonitrile, acrylics, 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 alloys, and the like. Bag 1000 includes retractor integration, providing both specimen containment and tissue retraction features. Additional retraction features as well as materials and configurations that may be incorporated into bag 1000 in variations of the present invention are described in U.S. Patent Application Publication No. 2005 / 0139994, which is incorporated herein by reference in its entirety.

[0127] Currently available morcellators generally cut tissue with exposed, unprotected devices, such as sharp blades or energy tips, within the body cavity. For most morcellators, this creates additional danger as the exposed blade / tip can easily contact unintended areas and injure organs, tissues, blood vessels, etc. Current morcellators cut tissue in open areas, so small pieces of cut tissue can be left behind after the tissue removal procedure. These pieces can lead women to endometriosis, where uterine cells attach to other organs or cell walls. These pieces can also contain cancer cells that must be completely removed. Currently, if the tissue is expected to be cancerous, the entire mass is removed openly rather than laparoscopically, which increases the patient's risk of infection and increases recovery time. Even if all the pieces are found, the extra step of searching the body cavity for smaller pieces of tissue adds to the surgery time. Additionally, current morcellators require two people to perform the procedure. One person must pull the tissue through the morcellator with the tenaculum while the other holds the remaining tissue mass from inside the body cavity near the tip of the rotating blade. As the procedure is being performed, the specimen typically falls or falls off the instrument that holds the specimen in place during morcellation. This adds additional time to the person responsible for positioning the specimen in front of the morcellator as they must find the tissue and re-clamp the instrument against it before placing the specimen in front of the morcellator again. Thus, while morcellation in a bag or other containment is desirable, the bag itself is prone to potential puncture and spillage of contents. The specimen bag in one variation of the present invention has a protective inner layer of material that is resistant to puncture by the jaws of the tenaculum and the rotating morcellator blade. Also, because the morcellator is locked in a stationary position using any of the stabilizers described above, the likelihood of the blade contacting the bag is greatly reduced.The specimen bag contains the entire tissue sample, so if any small pieces fall off of a larger specimen during morcellation, they are removed when the bag is pulled from the patient. This increases patient safety and reduces operative time for the morcellation procedure, as there is no need to search for leftover tissue pieces. The specimen bag supports the tissue and holds it in place, allowing the morcellation procedure to be performed by one person rather than two. This also reduces the time required to constantly reposition and re-clamp the specimen.

[0128] 128-134, tissue morcellator 3000 is a multi-component medical device used to capture and reduce tissue specimens, such as a uterus, inside the human body under laparoscopic surgical conditions to a size that can be removed through a small incision, orifice, or opening that may or may not include a laparoscopic port. Morcellator 3000 includes a gear housing 3016 that houses a gear train that is connected at its proximal end to a flexible transmission shaft 3018 that is connected to a motor, which rotates morcellator blade 3010, as can be clearly seen in FIG. 133. Morcellator 3000 has a central working channel lumen 3020 that runs through the length of morcellator 3000. The inner and outer tubes of morcellator 3000 are stationary and do not rotate relative to moving blade 3010 and do not present a moving surface relative to the tissue as it is removed through lumen 3020. In one variation, the morcellator 3000 includes a camera 3022. The camera 3022 can be integrally formed with the remainder of the morcellator 3000 or can include a separate add-on that slides over the morcellator shaft to connect with the morcellator 3000, as shown in FIG. 134. As further seen in FIG. 132, the distal end of the morcellator shaft includes a fixed protruding appendage that covers at least a portion of the distally extending blades to interrupt the morcellation of the tissue and prevent the tissue from rotating relative to the instrument.

[0129] 128-134, the morcellation system further includes a tenaculum 3012 having an elongated shaft 3028 and a jaw-like grasper at its distal end controlled by a handle 3024 at its proximal end that opens and closes 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 out the distal end of the morcellator shaft. The tenaculum handle 3024 is designed to be held vertically in either the left or right hand, and this ergonomic design is intended to optimize hand and arm movements to pull upward. The handle 3024 includes a lever 3030 that closes the jaws 3026 by squeezing toward the handle 3024, as shown in FIG. 129. Alternatively, the lever 3030 can be squeezed to open the jaws 3026. Because the lever 3030 is under spring tension, it will spring open away from the handle 3024, which may define a closed configuration for the jaws 3026, allowing the user to then focus on pulling upward on the tenon 3012 to extract tissue. Alternatively, the trigger may be under spring tension and the lever 3030 will spring open away from the handle 3024, opening the jaws 3026.

[0130] 130-132, the jaws 3026 of the tenaculum include a curved distal tip 3032. The jaws 3026 include upper and lower jaws that are hinged to one another. The upper and lower jaws each include a rounded, curved distal end that is devoid of any sharp points along the curve traced by the distal end 3032 as the jaws 3026 open and close. In the closed configuration shown in FIGS. 130, 131, the curved distal end 3032 presents no exposed sharp points or edges that may pose a danger to the integrity of the tissue or bag when in the open or closed configuration. The interior of the upper and lower jaws include teeth 3034. The distal tip 3032 also includes teeth 3034 that interlock from the upper and lower jaws to provide a positive hook to the grasped tissue while also providing a smoothly curved exterior to protect any surrounding tissue and / or bag. 132 shows the jaws 3026 in an open configuration and illustrates the path 3036 that the distal end 3032 follows as the tenaculum opens and closes. The curved distal end 3032 advantageously protects the bag being morcellated from being punctured as tissue is grasped. Even when the jaws 3026 are fully open, the curved distal end 3032 of the jaws can protect the bag from unwanted punctures.

[0131] 135A-135D and 136A-136B, a morcellation system includes a specimen collection receptacle bag 3002. The described morcellation system can be adapted for use with a powered morcellator as described above, or can be used with a manual morcellation. The bag 3002 is shown flat in FIG. 135A and rolled up in FIGS. 135B and 135C. The bag 3002 includes a bag ring 3004 that surrounds an opening or mouth of the bag 3004. FIG. 136A shows a tissue specimen 3006 captured within the bag 3002 and the bag ring 3004 being pulled to the exterior. FIG. 136B shows the bag ring 3004 being pulled completely through the body opening to expose the interior of the bag 3002 to the exterior of the body for removal of the specimen 3006 within the bag 3002. In Figure 136B, tissue guard 200 is shown ready for insertion into a body orifice. Although tissue guard 200 is shown, any tissue guard according to the present invention may be used.

[0132] 137A-137C and 138A-138C, another variation of a bag 3002 is shown. The bag 3002 includes a bag ring 3004 having an elongated cross-section, such as the cross-section shown in FIG. 137C. The bag 3002 of FIGS. 137A-137C is configured to be rolled down so that the side walls of the bag 3002 wrap around the bag ring 3004. FIG. 138A shows the bag 3002 with a tissue specimen 3006 inside of it. The bag ring 3004 is pulled to the surface of the body through a body orifice. FIG. 138B shows the bag ring 3004 fully extended to the surface, and FIG. 138C shows the bag ring 3004 rolled or flipped around itself as shown by the arrow in FIG. 138C and as previously described herein, reducing the length of the bag's sidewalls and bringing the contents of the bag closer to the surface which may allow for easier morcellation. The bag ring 3004 is not limited to having the cross-section of FIG. 137C, any cross-section that allows the bag to be rolled around the bag ring is within the scope of the present invention. The bag ring 3004 is both flexible so that it can be crushed and compressed into an elongated shape for insertion and removal through a small incision or body orifice. When released, the elastic bag ring 3004 expands to an open mouth configuration, allowing the specimen 3006 to be easily placed inside the bag 3002. The bag 3002 has an open top and a semi-rigid bag ring 3004 is attached to the top of the bag 3002 or near its mouth. The bag 3002 can be deployed in the body, such as in the abdomen, via a trocar or other deployment device. The bag 3002 can be manipulated with a grasper. The specimen 3006 is loaded into the bag 3002 and the bag 3002 is retrieved through a body wall 3056, such as the abdominal wall. Due to the large size of the specimen 3006, the entire bag 3002 does not pass through the small laparoscopic incision. The semi-rigid bag ring 3004 is the only part that can face the rest of the bag remaining inside the abdominal cavity. The cross section of the semi-rigid ring allows the bag 3002 to be shortened by a rolling technique.This not only shortens the bag 3002 but also aids in wound retraction. The tissue 3004 sample acts as an anchor to allow retraction of the wound opening and allows further access to the tissue 3006 by a powered or manual morcellation instrument. Once the bag 3002 is in place, morcellation can begin. As the tissue sample 3006 decreases in size, the semi-rigid bag ring 3004 can be rolled further to bring the tissue 3006 closer to the surface allowing easier access for morcellation. Once sufficient tissue 3006 has been removed, the bag 3002 can then be withdrawn from the patient. FIG. 138C shows the tissue guard 200 ready for insertion into the body opening and into the bag 3002.

[0133] 139A-139C, the bag 3002 is connected to a delivery shaft 3038 configured to open and close the mouth of the bag 3002. The delivery shaft 3038 is used to conveniently scoop the specimen 3006 when in the open mouth configuration. The delivery shaft 3038 is manipulated to close the mouth of the bag 3002 after the specimen 3006 has been captured, and brings the bag ring 3004 through the body opening to the surface for morcellation and removal of the specimen 3006. The bag 3002 has an open top with a semi-rigid bag ring 3004 attached to the top. The bag 3002 is attached to a two-pronged fork-like 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 greater precision and ease. The system can be deployed into the abdomen via a trocar cannula 3044. The specimen 3006 is loaded into the bag 3002 and the bag 3002 is retrieved through the abdominal body wall 3056. To retrieve the bag 3002, the forked shaft 3038 is pulled through the trocar cannula 3044 until the corner of the bag 3002 enters the distal tip of the trocar cannula 3044. Once the bag 3002 is engaged with the trocar cannula 3044, the bag 3002 can be pulled up through the wound opening to the surface. The entire bag 3002 does not pass through. The only part that can come up to the surface is the semi-rigid bag ring 3004. Once at the surface, the forked shaft 2038 can be removed from the semi-rigid bag ring 3004. The cross section of the semi-rigid bag ring 3004 allows the bag 3002 to be shortened by a rolling technique. This not only shortens the bag 3002 but also aids in wound retraction. The tissue sample 3006 acts as an anchor to allow retraction of the wound opening, allowing the morcellation instrument further access to 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 rolled further to bring the tissue 3006 closer to the surface allowing easier access by the morcellation instrument and blade. Once sufficient tissue 3006 has been removed, the bag 3002 can then be withdrawn from the patient. In an alternative arrangement, the bag 3002 is provided with a second bag ring 3040. The second bag ring 3040 is attached to the bag 3002 approximately mid-distance down the bag 3002. This second bag ring 3040 acts as an anchor allowing the bag 3002 to be shortened while at the same time retracting the wound to its maximum possible opening. The bag 3002 is attached to a two-pronged, fork-like delivery shaft 3038. The forks are semi-rigid. As the second bag ring 3004 is external to the patient, the first bag ring 3004 is rolled / flipped around itself. The cross section of the semi-rigid bag ring 3004 allows the bag 3002 to be shortened by a rolling technique. This not only shortens the bag 3002 but also aids in wound retraction. The second bag ring 3040, halfway down the bag 3002, acts as an anchor allowing maximum retraction of the wound opening. This allows further access to the tissue 3006 by various morcellation instruments. Once the bag 3002 is in place, morcellation can begin. Once sufficient tissue 3006 has been removed, the bag 3002 can then be withdrawn from the patient.

[0134] 140A-140B and 141A-141D, another variation of a bag 3002 according to the present invention is shown. The bag 3002 includes an interior and a sidewall defining a mouth. A first bag ring 3004 and a second bag ring 3040 are provided. The second bag ring 3040 is spaced distally from the first bag 3004 and interconnected by a sidewall. The bag 3002 includes a balloon 3042 disposed at a bottom of the bag 3002. The balloon 3042 forms at least a portion of the base of the bag and has a deflated state and an inflated state. The interior of the balloon 3042 is interconnected to an inflation pressure source that provides a positive pressure to the balloon 3042. The inflation pressure source can also provide a negative pressure to remove inflation fluid and deflate the balloon 3042 as desired by a user. The inflation pressure source is activated manually or automatically by a user. The balloon 3042 at the base of the bag 3002 is spaced distally from the second bag ring 3040 as shown in FIG. 140A. FIG. 141A shows the bag 3002 inserted into the body through the body wall 3056, with the first bag ring 3004 pulled to be external to the body to provide access to the interior of the bag 3002 so that the specimen 3006 disposed therein can be extracted from the bag 3002. FIG. 141B shows the proximal end and mouth of the bag 3002 being pulled until the second bag ring 3040 substantially engages the underside of the body wall 3056. FIG. 141C shows the first bag ring 3004 rolled on itself and the side walls of the bag 3002 wrapped around the first bag ring 3004. As the first bag ring 3004 is rolled, the length of the sidewall located between the first bag ring 3004 and the second bag ring 3040 decreases. This decrease in sidewall length brings the base of the bag 3002 and the specimen disposed within the bag 3002 closer to the surface opening of the body. FIG. 141D shows the balloon 3042 in an inflated state, which raises the specimen 3006 closer to the opening for easier visualization, morcellation, and removal. The balloon 3042 advantageously provides an additional protective interface or barrier between the inside and outside of the bag 3002.For example, if a morcellation instrument, such as a scalpel, powered morcellator, or grasper, accidentally breaches the proximal end of the balloon 3042 facing the inside of the bag 3002, the balloon 3042 will deflate, but the containment barrier to the outside or sidewall of the bag will remain intact, so the overall integrity of the bag 3002 will not be compromised. In essence, the balloon 3042 provides a double wall that provides additional protection at the base location that is likely to encounter a sharp instrument during the morcellation process. The inflatable base of the bag 3002 also provides a pedestal effect for the tissue specimen 3006, even if the tissue 3006 is not centered directly over the balloon 3042. The inflatable base of the bag also provides a moat-like location for bodily fluids, such as blood, to drain from the specimen 3006 when in an inflated state. When inflated, the inner wall of the balloon 3042 is spaced very far from the outer wall in a base double wall arrangement, which keeps the outer wall safely away from instruments and increases the likelihood of the inner wall remaining intact in the event of a breach. A double wall sidewall can be used throughout the bag 3002, not just in base locations. A breach of the balloon 3042 and the resulting subsequent deflation of the balloon visually notifies the user that a sharp instrument has struck the balloon, alerting the user to take extra care to ensure the safety of the outer wall as the extraction continues. This is in contrast to a single wall configuration, where a breach of the sidewall would mean a breach of the outside of the bag 3002 without warning. After the specimen 3006 is brought to the surface, it can be easily viewed from outside the body through the mouth of the bag 3002, making morcellation easier to proceed with. The balloon 3042 can be any inflatable member and can be integrated into the floor of the bag 3004. As morcellation is performed, the tissue reduces in size, which can cause the specimen to get lost in the bag 3002 and become difficult to find by the morcellator and instruments. By inflating the balloon 3042, the tissue 3006 is raised closer to the end of the morcellator and instruments, allowing easier access to the tissue sample 3006.

[0135] 142A-142C and 143A-143D, another variation of a containment bag 3002 with inflatable side walls is shown. The bag 3002 has side walls formed with an open top that serves as a mouth, i.e., an entrance into the interior of the bag 3002. The bag 3002 includes a first semi-rigid bag ring 3004 attached to the top near the opening. Additionally, there is also a second bag ring 3040 attached approximately mid-distance down the bag 3002. The second bag ring 3040 serves as an anchor to shorten the bag 3002, retracting the wound to its maximum possible opening. The bag 3002 utilizes air channels 3008 to aid in expanding the lower portion of the bag 3002 that contains the specimen. By expanding the lower portion, the visibility of the specimen from the top side is greatly enhanced. This also aids the speed at which the morcellation can be performed. The bag 3002 is attached to a two-pronged, forked delivery shaft 3028. The forks are semi-rigid. The purpose of the delivery shaft 3028 is to allow the bag to be manipulated with greater precision and ease. The system can be deployed across the body wall 3056 into the abdomen or other body locations or orifices. The tissue sample 3006 is loaded into the bag 3002, which is retrieved through the abdominal body wall. To retrieve the bag 3002, the forked shaft 3028 is pulled through the trocar until the corners of the bag 3002 are inside the trocar. Once the bag 3002 is engaged with the trocar, the bag can be pulled up to the surface as shown in FIG. 143A. Once at the surface, the forked shaft can be removed from the semi-rigid bag ring 3004. The entire bag 3002 does not pass through. It is possible for the semi-rigid first bag ring 3004 and a portion of the side wall to come up to the surface. The cross section of the semi-rigid bag ring 3004 allows for shortening of the bag 3002 by a rolling technique as shown by the arrows in Fig. 143C. This not only shortens the bag 3002 but also aids in wound retraction as shown in Fig. 143C.The second bag ring 3040, halfway down the bag 3002, acts as an anchor to allow maximum retraction of the wound opening. This allows further access to the tissue 3006 by the morcellation instrument. The bag 3002 serves both containment and retraction functions. Once the wound is retracted, the air channels 3008 can be inflated as shown in FIG. 143D and the optional tissue guard 200 can be used. The air channels 3008 expand outwardly creating free space around the tissue 3006. This allows more of the tissue 3006 to be in the free space. More free space allows the tissue 3006 to tumble and move as it is being morcellated. Once the bag 3002 is in place, the morcellation can begin. Once enough tissue 3006 has been removed, the bag 3002 can then be withdrawn from the patient. In an alternative variation, the base of the bag 3002 may also be inflatable as described with respect to Figures 140-141.

[0136] 144A-144C and 145-145D, another variation of a containment bag 3002 having inflatable sidewalls is shown without a second bag ring 3040 and only with a first bag ring 3004. The bag 3002 has an open top with a semi-rigid first bag ring 3004 attached to the top. The bag 3002 utilizes air channels 3008 to assist in expanding a lower portion of the bag 3002 containing a specimen 3006. The air channels 3008 are disposed circumferentially around the periphery of the bag at the lower portion of the bag. The air channels 3006 are interconnected and connectable to an inflation pressure source. Positive inflation pressure will inflate the channels and negative pressure will act to actively deflate the channels 3008. The deflated configuration is shown in FIG. 145A and the inflated configuration is shown in FIG. 145B-145D. In one variation, the air channel, which is the most proximal air channel, closest to the opening of the bag, is annular and larger than the other air channels. The air channel 3008 is a tubular ring-shaped lumen that can be fluidly connected to one or more adjacent tubular ring-shaped lumen and is configured to be connectable to an inflation fluid source. This most proximal first annular ring-shaped air channel lumen provides a counterforce to the underside of the abdominal wall, allowing for greater retraction when the upper bag ring 3004 is rolled down to cause retraction. Thus, the first annular ring-shaped lumen acts similarly to the second bag ring 3040 of the previous variation. Also, by expanding the lower portion, visibility of the specimen 3006 from the upper side is greatly increased. This also aids the speed at which morcellation can be performed. The bag 3002 is attached to a two-pronged, fork-shaped delivery shaft 3038. The forks are semi-rigid. The purpose of the delivery shaft 3038 is to allow the bag to be manipulated with greater precision and ease. The system can be deployed into the abdominal body through a trocar. The specimen 3006 is loaded into the bag 3002, which is then retrieved through the abdominal body wall. To retrieve the bag 3002, the forked shaft is pulled through the trocar until the corners of the bag are inside the trocar.Once the bag 3002 is engaged with the trocar, it can be pulled up to the surface. The entire bag does not go through. Only the semi-rigid bag ring 3004 and a portion of the bag sidewalls are allowed to come up to the surface as shown in Figs. 145A-145D. Once at the surface, the forked shaft can be removed from the semi-rigid bag ring 3004. The cross section of the semi-rigid bag ring 3004 allows the bag 3002 to be shortened by a rolling technique as shown by the arrows in Fig. 145D. This rolling action not only shortens the bag 3002 by rolling up the bag sidewalls, but also aids in wound retraction. The bag 3002 is then inflated. The bag 3002 can also be inflated prior to rolling as shown. The first annular air channel 3008 halfway down the bag acts as an anchor to allow maximum retraction of the wound opening. This allows further access to the tissue by the morcellator. The air channels 3008 expand outwardly, creating free space around the tissue 3006. This allows more of the tissue 3006 to tumble and move as it is being morcellated. Once the bag 3002 is in place, morcellation can begin. Once sufficient tissue 3006 has been removed, the bag 3002 can then be withdrawn from the patient. In an alternative variation, the base of the bag 3002 can also be inflatable as described with respect to FIGS. 140-141.

[0137] Many different types of materials can be used for the bag and the semi-rigid ring. It may be desirable to use multiple materials in the same bag, such as a hybrid of polymer and woven textile. The semi-rigid ring can be made from many flexible polymeric materials, including but not limited to pelletane, silicone, KRATON polymer, IROGRAN polyester-based thermoplastic polyurethane, metals, polymers, plastics, rubber, etc.

[0138] Any of the containment bags described herein, including the inflatable bag 3002, can be used with a guard or shield configured to be placed within the bag 3002 to protect the bag sidewalls and adjacent tissue edges from sharp manual or powered morcellation instruments. Additional examples of guards are shown in FIGS. 146-148. FIGS. 146A-146B show a cylindrical rigid guard 3047 having a cylindrical proximal end 3048 and a funnel-shaped distal end 3050 that flares outwardly. The funnel-shaped guard 3047 acts to focus or funnel the tissue toward the cutting blade. The central lumen of the guard 3047 expands in the distal direction. The funnel shape also helps spread the sidewalls of the bag 3002 apart, providing clearance for morcellation and preventing the specimen bag from engaging the blade. The guard 3047 can also include a spring-loaded guard feature that prevents the blade from being exposed unless tissue is engaged. This makes the morcellator safer to handle.The blade guard can be adapted to work with a spring loaded guard.

[0139] 148A-B, the guard 3047 has an inverted funnel or lead-in guard at the distal end with a central lumen that narrows toward the distal end 3050. The lead-in guard 3047 allows for easier coring of the tissue 3006. The blade guard 3047 is cone shaped with the narrow end 3050 facing in the same direction as the leading edge of the morcellation tool blade. The guard 3047 pushes the surrounding tissue away and aside once the blade engages the tissue 3006.

[0140] 147A-147B, another variation of the guard 3047 is shown that includes anti-rotation studs 3052 that extend from the inner surface of the guard 3047 into the central lumen. The inwardly protruding anti-rotation studs 3052 keep the lumped mass of tissue 3006 from getting caught by the rotating blade and rotating tube and spinning together when a powered morcellator is used. If the tissue 3006 spins with the blade there will be no relative blade motion and therefore the tissue will not be cut. The anti-rotation studs 3052 can also be located on the exterior of the guard 3052 and extend outward from the outer surface of the guard 3047. These protrusions prevent the guard 3047 from rotating. The internal anti-rotation studs 3052 also aid in guiding and leading 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 variation, a bipolar vertical tissue separator can be included in the guard. The bipolar vertical tissue separator feature functions to cut the core of tissue from the mass. This mitigates the problem of coring and not being able to separate the morcellated core from the larger mass. This feature can be adapted to work with any blade guard. Also, a light can be included and integrally formed with the guard 3047. The purpose of the light source, such as an LED, is to enhance and improve visibility inside the tissue bag 3002 for better scope visibility. This feature can be adapted to work with any blade guard. The variation of Figures 147A-147B further includes a number of holes 3054 extending across the guard 3047. These holes 3054 act as vacuum bypass holes 3054 configured to prevent the bag 3002 from being pulled into the blade when a vacuum is used to pull the tissue 3006 from the bag 3002, such as with a vacuum powered morcellator system. This is accomplished by leaving radial holes 3054 exposed around guard 3047 at all times.Once tissue is engaged with the blade, the vacuum bypass holes do not affect the vacuum interface with the tissue. This feature can be adapted to work with any blade guard used under vacuum.

[0141] Morcellation is performed manually by the surgeon using a scalpel or electrosurgical instrument. Instead of utilizing a powered morcellator, any bag described herein can be used with manual morcellation. The bag is inserted into the body cavity through an incision. The target tissue is placed into the bag and the opening of the bag is pulled through the incision. A bag guard as described herein is inserted into the bag and held near the bag opening and optionally connected to the proximal end of the bag so that the bag opening is held in an open position. The surgeon uses a grasper to grasp the tissue and pull it towards the opening and into the guard's location. The surgeon then uses a scalpel instead of a powered morcellator to cut the tissue into smaller pieces and pull it out of the body. The cutting is done at and / or against the guard to prevent the bag from being accidentally punctured by the scalpel. The bag with the small pieces of tissue or no tissue at all is removed from the body cavity along with the bag guard.

[0142] The system includes a specimen collection receptacle bag 3002 attached to the shaft. The bag 3002 can be deployed inside the body and can capture the desired tissue 3006 after it has been ablated. Once the specimen 3006 is placed inside the bag 3002, there is a semi-rigid ring 3004 attached to the bag opening that can be pulled outside the body through a laparoscopic wound, incision, opening, orifice access site. After the bag opening ring 3004 is pulled outside the patient, the lower bag portion that remains inside the body cavity containing the specimen 3006 contains air channels 3008, which are inflated to create a structure that provides an internal anchoring mechanism for the bag 3002 against the internal pneumoperitoneum pressure. The outer bag opening ring 3004 can then be rolled down and the wound opening retracted in the same manner as described above. The inflated portion of the bag 3002 that remains inside the body cavity containing the specimen 3006 is now exposed to the surface. Once the specimen bag 3002 is retracted into place, a morcellator device 3000 with a central hollow spinning blade tube 3010 is attached to the bag opening ring. The morcellator 3000 is locked in a stationary position and the blade tube 3010 is inserted down through the wound into the lower region of the bag 3002 where the specimen 3006 is located. At that point, the morcellator 3000 is turned on and the blade tube 3010 is rotated. Once the tube 3010 is rotated, a tenacious hook 3012 is inserted through the hollow blade tube 3010 to grasp the tissue and pull it up into the spinning blade 3010, thereby reducing the large specimen 3006 into a smaller core piece that can be removed through a small laparoscopic wound site. The morcellator 3000 also includes a camera 3014 at the distal end of the morcellator 3000 for visualization of the interior of the specimen bag 3002. Once the tissue 3006 has been completely removed or reduced to a size sufficient to be pulled through the wound 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 to complete the procedure.

[0143] 149, a system is shown including a powered morcellator 4000 and a bag 4002 connected to the side of a morcellator shaft 4004. With additional reference to FIGS. 150A-150D, the morcellator 4000 includes a handle 4006 connected to the shaft 4004, with one or more blades 4008 at the distal end of the shaft 4004. The morcellator 4000 further includes a motor 4010 disposed on the handle 4006. The motor 4010 is configured to connect to and rotate a gear pinion 4012. The gear pinion 4012 is further connected to a gear train including a gear inner tube 4012 and a gear outer tube 4016. The gear outer tube 4016 is further connected to a spacer 4018, which is in turn connected to an outer shaft 4020. The distal end of the outer shaft 4020 is connected to the blade 4008. The gear inner tube 4014 is connected to an inner shaft 4026 which in turn is connected to a second blade 4022. The gear outer tube 4016 and the gear inner tube 4014 are configured to rotate in counter-rotating directions creating counter-rotating blades at the distal end. As counter-rotating tubes there are two tubes. One tube is inside the other. The inner tube rotates in one direction and the outer tube rotates in the opposite direction. In one variation 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 when compared from the perspective of the blade. All tube configurations can have an outermost tube that holds the blade guard configuration. In another variation the inner tube is stationary relative to the rotating outer tube. The outer tube has a blade attached to its end and is capable of rotation. The concept of a stationary inner tube is to create a smooth member that allows the tissue to move up the working channel more easily. In another variation a single outer tube rotates and there is only one tube with a blade attached to its end. The interior of the tube is featureless and smooth. In another variation there are three tubes, the inner and outer tubes are stationary and the middle tube rotates. The blades are attached to the ends of the middle rotating tube and extend beyond the inner and outer tubes. The stationary outer tube is there to protect anything from being rubbed by the rotating middle tube.The stationary inner tube is to encourage the tissue to move up the tube more easily. In another variation, a riffled tissue advancement tube is provided in any configuration for a rotating tube that has back contact with non-occluded tissue on its inner surface. A riffle-like pattern is formed on the inner surface of the rotating tube that exerts an axial force on the morcellated tissue to move it up the tube away from the blade. In yet another variation, an auger type tissue advancement tube is provided in any rotating inner tube configuration. The tube has multiple flutes that travel the length of the tube interior. The ends of the flutes grip the tissue and move it up the flutes 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 are provided with an overmolded seal or quad ring seal 4046 to seal them, as shown in FIG. 150B. The electric motor is enclosed entirely within the handle 4006 and may be battery powered or connected to an external power source.

[0144] A spring loaded blade guard 4024 operates to cover or uncover the blades 4008, 4022, and a trigger 4028 operates to start the motor 4010. The spring loaded blade guard 4024 operates to only allow the blade 4008 to be exposed when tissue contacts the end of the blade guard for added safety. The blade guard 4024 shaft with opening and proximal knob can be removable and the blade guard can be non-rotating. The inner and outer shafts 4026, 4020 are coaxial and define a working channel 4030 in the middle. At the proximal end, a conical funnel 4032 is provided 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 adapted to connect to a specimen receptacle 4034, shown in FIG. 151, and a vacuum source for extraction of the morcellated specimen. The specimen receptacle 4034 is a transparent container including an inlet port 4038 disposed on a removable lid and a port 4040 for connection to a vacuum source. The port 4040 connected to the vacuum source can include a valve for turning the vacuum on and off and can be configured to be electronically actuated. The proximal end of the morcellator 4000 can also be adapted to connect to a seal assembly 4042 as shown in FIG. 150D. The seal assembly 4042 can include a zero seal and a septum seal for sealing 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 for connection to a source of fluid under pressure. The blade guard 4024 includes at least one side slot or side window opening 4036 configured to expose the blade through the side and to receive tissue to be morcellated through the side of the morcellator 4000 and into the working channel 4030. 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 morcellated into the working channel 4030 at the distal opening.

[0145] 152, a bag 4002 configured to attach to a morcellator shaft 4004 having a side opening 4036 is now described. In one variation of the bag 4002, the bag 4002 has an open top 4048 with a means for closure 4050. The morcellator shaft 4004 has a rounded end and is adapted to connect with the bag 4002. The side of the morcellator shaft 4004 has a windowed opening 4036. The specimen collection system is inserted into the body, for example, via a trocar or via an open wound or body orifice. The bag 4002 is then opened and the tissue specimen is placed into the bag 4002. The bag 4002 is then sealed by the closure means 4050. The morcellator shaft 4004 is attached to the morcellator 4000 and morcellation can begin. Alternatively, a bag tube 4066 is provided and the morcellator 4000 is easily attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in FIG. 152 and FIG. 159. The bag 4002 can be pre-attached to the bag tube 4066. Once the specimen is reduced, the specimen collection system is withdrawn from the patient. Examples of morcellators are 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 incorporated by reference herein as if fully set forth.

[0146] 153-157, various bag closure means are described. In Figs. 153A-153B, a drawstring 4052 located on the bag top 4048 is used to close the open top 4048. In Figs. 154A-154B, a ziplock or zipper type 4054 closure 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, another closure means includes a grommet 4056 formed on the bag 4002 near the bag top 4048. A grasper 4058 or other device is inserted into the opening of the grommet 4056 and then twisted to roll down the bag 4002 and close the open top 4048 as shown in Fig. 155C. In Figures 156A-156B, the top 4048 is provided with a hook and loop fastener 4060. Both sides of the hook and loop fastener are brought together to close the open bag top 4048. In Figures 157A-157B, the bag top 4048 includes a number of grommet openings 4062. Specifically, four openings are provided. An instrument such as a grasper 4058 is used to grasp all of the openings 4062 and then twist as shown in Figure 157B to roll the openings closed.

[0147] To protect the bag 4002 and to prevent it from entering the side slot 4036 on the morcellator shaft 4004 and coming into contact with the rotating blade 4008, a plastic guard 4064 is provided, as shown in FIGS. 158A-158E. The plastic guard 4064 is formed of a one-piece semi-rigid plastic and is configured to fold and be inserted into the morcellator slot 4036. The plastic guard 4064 is formed of a stiffer material than the bag 4002 and is configured to surround the side opening 4036 and to provide a through-like or funnel-like opening to spread the bag 4000 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 means 4050. The bag 4002 also has a semi-rigid structure at the side opening 4036 of the morcellator shaft 4004, allowing tissue to be more easily loaded into the bag 4002. The specimen collection system is introduced into the body via a trocar or open wound or orifice or other delivery mechanism. The bag 4002 is then opened and the tissue specimen is placed into the bag 4002. The bag 4002 is then sealed via the closure means 4050. The morcellator 4000 is attached to the proximal end of the morcellator shaft 4004 to begin morcellation. Alternatively, a bag tube 4066 is provided and the morcellator 4000 is easily attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in FIG. The bag 4002 may be pre-attached to the bag tube 4066 with or without a plastic guard 4064 or reinforced rigid section near the distal opening of the bag tube 4066. The morcellator shaft 4004 and bag tube 4066 are held together by friction via a knob attached to the bag tube 4066. The knob interfaces with the morcellator handle by a snap or friction fit engagement. Once the specimen is reduced, the specimen retrieval system is withdrawn from the patient. The semi-rigid structure of the guard 4064 may be made of spring steel, nitinol or molded plastic.All three of these material variations allow for closure of the bag 4002 by using a drawstring method or by pinching the ends and rolling the structure to close the bag 4002. In another variation shown in FIG. 160, the bag 4002 is attached to a bag tube 4066. The bag 4002 has a closed end. The opening 4068 of the bag 4002 is on the side of the bag 4002. The bag 4002 also has a semi-rigid structure at the opening, allowing tissue to be more easily loaded into the bag. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a windowed opening 4070. The specimen retrieval system is inserted into the abdominal body through a trocar or open wound. The bag 4002 is then opened and the tissue specimen is placed into the bag 4002. The bag 4002 is then sealed and the morcellator 4000 is attached to begin the morcellation. Once the specimen is reduced, the specimen retrieval system is withdrawn from the patient. The side opening 4068 may include a spring steel, nitinol or molded plastic reinforcement located in the middle of the side wall of the bag 4002. The side opening 4068 springs open into an oval to facilitate easier insertion of the specimen tissue into the bag 4002. All three of these material variations may close the bag using a drawstring method or by pinching the ends and rolling the structure to close the bag 4002. In another variation, the spring steel, nitinol or molded plastic is located near the bag tube 1066 as shown in FIG.

[0148] In another variation shown in Figures 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 than the other. The larger end 4072 is semi-rigid with spring steel, nitinol or plastic material. A different 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 that attaches to the bag tube 4066. The clamp 4076 attaches around the rigid blade guard 4064. The taper of the rigid blade guard 4064 helps the clamp 4076 to seat on the rim and not slide off the bag tube 4066. The bag tube 4066 has rounded ends. The side of the bag tube 4066 has a windowed opening 4070. The bag 4002 is first introduced into the body through an opening, orifice, or open wound in the abdomen via a trocar, delivery shaft, instrument, or other deployment method. The larger end 4072 of the bag is then opened and positioned around the tissue sample 4078. The larger 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 using clamp 4076. The morcellator 4000 is attached and morcellation begins. Once the specimen 4078 has been reduced, the specimen retrieval system is withdrawn from the patient.

[0149] In another variation shown in Figs. 163A-163C, the bag 4002 is attached to a bag tube 4066, referred to as the 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 sheath tip has two holes to facilitate 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 the withdrawal of the Nitinol. The side of the tube has a windowed portion 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 deploying the drawstring 4052, and the tissue specimen 4078 is retrieved by enclosing the tissue specimen 4078 in a net formed by the Nitinol and the bag 4002. This can be done with or without the assistance of a grasper or dissector. Once the tissue 4078 is enclosed, the nitinol can be retrieved proximally via the drawstring 4052, which closes the bag 4002 around the tissue sample 4078 and seals the bag 4002. The morcellator is attached and begins morcellation. Once the specimen is reduced, the specimen retrieval system is withdrawn from the patient.

[0150] In another variation, the bag 4002 has an open top with a semi-rigid ring attached to the top. The bag 4002 can be rolled tight and then deployed into the abdomen via a trocar. The bag 4002 can then be opened internally by manipulation with a grasper. The specimen 4078 is loaded into the bag 4002 and the bag 4002 is retrieved through the abdominal wall. The entire bag 4002 does not pass through. Only the semi-rigid ring is allowed to come to the surface. Morcellation can begin. Once sufficient tissue 4078 has been removed, the bag 4002 can then be withdrawn from the patient.

[0151] The tissue guards described herein are typically used in conjunction with a containment bag. The bag is placed inside the body through a body opening. A body opening refers to any point of entry into a patient, and can include, but is not limited to, an incision site and a natural orifice. The target specimen is typically too large to be safely removed through a body opening and manipulation, such as cutting with a blade, is required to extract the target specimen through the body opening. Minimally invasive, laparoscopic body openings are typically smaller than the size of the target specimen. The target specimen is placed inside the bag and the mouth of the bag is pulled outside the patient. The guard is placed inside the mouth of the bag and anchored across the body opening, drawing the target specimen into the lumen of the guard. While in the lumen of the guard, the target specimen is in a protected morcellation zone where the surgeon can reach and cut the target specimen with a blade for extraction. The guard provides protection from stray blades and also provides a direct cutting surface that can be positioned to reduce tissue. The overall length of the guard typically defines the length of the morcellation zone that protects the bag and tissue at the edge of the body opening. Additionally, a retractor can be used. The retractor can be integrally formed with the bag or can be a separate stand-alone device. An exemplary retractor described herein is a two-ring retractor with a flexible sidewall material located between two rings. The sidewall of the retractor can be rolled around the first ring and configured to retract tissue at the margin of the body opening. If a retractor is used, it can be placed inside the bag between the marginal tissue and the bag or between the bag and the guard. The above description describes various variations of the guard, bag and retractor used in manual morcellation. In powered morcellation, the guard is inserted inside the bag and the morcellation is performed. In another variation of powered morcellation, a stability cap is connected to the proximal ring of the bag or the proximal end of the guard and the powered morcellation is performed.The stability cap serves to position the blade longitudinally to ensure that it does not extend beyond a predefined morcellation zone inside the guard or beyond the distal end of the guard by a safe short distance. In another variation of powered morcellation, a retractor is used, where the retractor is placed between the marginal tissue and the bag or between the bag and the guard as described above, and morcellation is performed. In the previous variation, a stability cap can be used to connect with the proximal ring of the retractor, the proximal ring of the bag, or the proximal end of the guard, and morcellation is performed. In addition to the variations described above, when performing a procedure such as a hysterectomy, any one of the following techniques can be used in conjunction with any one of the variations described above. In one variation, a bag is placed through the vagina, the target specimen (e.g., uterus) is placed inside the bag while the bag is inside the body cavity, and then the mouth of the bag is pulled through an abdominal incision, where the guard is inserted into the mouth of the bag, and morcellation, extraction, and removal of the bag are performed at the abdominal opening. In another variation, the bag is placed through the vagina, the target specimen (e.g., uterus) is placed inside the bag while the bag is inside the body cavity, then the mouth of the bag is pulled back through the vaginal canal where the guard is inserted into the mouth of the bag, and morcellation, extraction, and removal of the bag are performed in the vagina. In yet another variation, the bag is placed through an abdominal incision, the target specimen (e.g., uterus) is placed inside the bag while the bag is inside the body cavity, then the mouth of the bag is pulled back through the vaginal canal where the guard is inserted into the mouth of the bag, and morcellation, extraction, and removal of the bag are performed in the vagina. In one other variation, the bag is placed through an abdominal incision, the target specimen (e.g., uterus) is placed inside the bag while the bag is inside the body cavity, then the mouth of the bag is pulled back through the abdominal incision where the guard is inserted into the mouth of the bag, and morcellation, extraction, and removal of the bag are performed in the vagina. In another approach to morcellation of the uterus or other target specimen, the bag can be omitted.In such cases, an incision is made in the abdominal wall, a guard is placed across the abdominal incision, the uterus or other target specimen is dissected and pulled through the guard's central lumen, and morcellation and extraction is performed at the abdominal incision. Alternatively, the target specimen (e.g., uterus) is approached through the vagina, a guard is placed inside the vaginal canal, the target specimen is dissected and pulled through the guard's central lumen, and morcellation and extraction is performed at the vagina. As yet another variation of the abdominal approach without a bag, the procedure can be viewed through a laparoscope inserted through the vagina. As a further variation of the vaginal approach without a bag, the procedure can be viewed through a laparoscope inserted through an abdominal incision.

[0152] In some cases, a guard is not used. In one such variation that does not use a guard, a bag is placed inside the body cavity via the vaginal canal, a target specimen is placed inside the bag, the mouth of the bag can be pulled through an abdominal incision, a retractor can be placed inside the bag across the abdominal incision, and morcellation, extraction, and removal of the bag is performed at the abdominal incision. In another variation that does not use a guard, a bag is placed inside the body cavity via the vaginal canal, a target specimen is placed inside the bag, the mouth of the bag can be pulled back through the vaginal canal, a retractor can be placed inside the bag inside the vaginal canal, and morcellation, extraction, and removal of the bag is performed vaginally. In another variation that does not use a guard, a bag is placed inside the body cavity via an abdominal incision, a target specimen is placed inside the bag, the mouth of the bag can be pulled back through the vaginal canal, a retractor can be placed inside the bag inside the vaginal canal, and morcellation, extraction, and removal of the bag is performed vaginally. In another variation that does not use a guard, a bag is placed inside the body cavity through an abdominal incision, the target specimen is placed inside the bag, the mouth of the bag is pulled through the abdominal incision, and a retractor can be placed inside the bag inside the vaginal canal, with morcellation, extraction, and removal of the bag occurring at the abdominal incision. In any of the variations that use a retractor without a guard, it is preferable to use any of the cut-resistant retractors previously described. Also, in any of the variations that use a retractor without a guard, the retractor can be placed between the bag and the tissue margin. Also, in any of the variations that use a retractor without a guard or without a retractor, it is preferable to use any of the cut-resistant bags previously described. Powered morcellation can also be used with any of the methods that use a guard. In such cases, a stability cap is used and connected to the proximal end of the bag or to the proximal ring of the reactor.

[0153] In a variation of using a retractor without a guard, a cut-resistant retractor is provided. The retractor has a first ring and a compressible second ring interconnected by webbing or sidewalls. The retractor is configured to roll up the webbing around the first ring to reduce the length of the retractor and retract the tissue margins. The bottom ring is inserted through the body opening and resides inside the patient while the top ring of the retractor resides on the patient. The top ring, like the bag, is rolled / flipped on itself to draw the bottom ring of the retractor closer and bring the sidewalls into a taut relationship between the rings. The bottom ring of the retractor advantageously retracts a portion of the bag inside the patient away from potential damage that may result from puncture and tearing from the blade. At least a portion of the webbing is made of a puncture-resistant cut-resistant material. The retractor is configured to be inserted into the containment bag and into the body opening to retract the bag and tissue margins, with the first ring of the retractor and the mouth of the containment bag residing outside the patient, and the second ring of the retractor and the remaining portion of the containment bag residing inside the patient. This positioning of the bag between the retractor and the tissue margins at the body opening anchors the bag to the patient's body. In one variation, only a distal portion of the webbing length, approximately 4 inches, is made of KEVLAR, DYNEEMA or other cut-resistant material, and the proximal portion of the webbing is not made of a cut-resistant material, but is made of polyurethane or other flexible film. This positioning allows the proximal end of the webbing to more easily roll around the first ring during retraction. As the length of the webbing is reduced by rolling, the distal cut-resistant portion of the webbing advances closer to the proximal end or first ring of the retractor and into a position that protects the morcellation. With less cut-resistant material, which can be thick and bulky, the retractor is less expensive and the first ring is easier to flip and roll because there is less cut-resistant material rolled around it. In another variation, the entire webbing is made of cut-resistant material.In another variation, for example for vaginal use, only the proximal portion of the webbing, approximately 5 inches in length, is cut resistant made from KEVLAR, DYNEEMA or other cut resistant material, and the distal portion of the webbing is not made from a cut resistant material but is made from a polyurethane or other flexible film for additional flexibility and anchoring at the distal end. In vaginal surgical procedures such as a full laparoscopic hysterectomy, the first ring at the proximal end does not need to be rolled down as much. Thus, the proximal end of the webbing is made from a cut resistant material, as compared to abdominal surgical procedures where the webbing is rolled significantly around the first ring and the proximal end is not made from a cut resistant material.

[0154] According to one aspect of the present invention, a contamination prevention system for manual or powered in situ morcellation is provided. The system includes a containment bag having a mouth and a shield configured to be removably inserted into the mouth of the bag. The shield has a central lumen that provides a working channel for morcellation while protecting the bag and surrounding tissue.

[0155] According to another aspect of the present invention, there is provided a device for safely removing a tissue specimen from a body cavity through a body opening smaller than the tissue specimen, the device includes a removable shield configured to be anchored to the body opening, the device further includes a bag or retractor positioned between the body opening and the shield.

[0156] In accordance with another aspect of the present invention, there is provided a shield having a sidewall defining a central opening, the shield including a C-shaped, concave outer surface for anchoring the shield within a body opening.

[0157] According to another aspect of the invention, there is provided a shield having side walls defining a central opening. The shield includes a C-shaped concave outer surface for anchoring the shield within a body opening. The shield separates such that one portion of the shield nests within another portion of the shield, and the shield is expandable from a contracted lateral configuration to an enlarged lateral configuration, and vice versa, by altering the nesting portion of the shield.

[0158] According to another aspect of the invention, there is provided an expandable shield having side walls 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 when in the second configuration, the dimension being a longitudinal dimension and / or a lateral dimension.

[0159] In accordance with another aspect of the present invention, a system is provided for preventing the potential spread of cancer cells when removing a large tissue specimen through a small body opening. The system includes a container and a morcellation zone. The morcellation zone is insertable into and removable from the container. The morcellation zone protects the container from penetration by a morcellation instrument.

[0160] In accordance with another aspect of the present invention, a shield is provided including a blade connected to the shield, the blade movable relative to the shield along a predetermined path, the shield surrounding at least a portion of the predetermined path to protect tissue surrounding a body opening.

[0161] 164-167, a shield 5000 according to the present invention is shown. The shield 5000 includes a band of flexible cut-resistant material. The shield 5000 has an inner surface 5002 and an outer surface 5004 interconnected by top and bottom ends 5006, 5008 and first and second ends 5010, 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 defines a convex-like shape, as shown in FIGS. 164-167, where the lumen diameter is larger at the top end 5006 and bottom end 5008 as compared to the lumen diameter at a central or trunk portion of the band. In one variation, the inner surface 5002 defines a constant lumen diameter from the top end 5006 to the bottom end 5008, or defines an angled or funnel-like shape or other curvature or shape. The outer surface 5004 is substantially conforming in shape to the inner surface 5002 and defines a band of substantially uniform thickness, although the invention is not so limited and the outer surface 5004 can take a different shape than the inner surface 5002 and / or have a different band thickness along the long axis. The curved funnel-like or C-like concave shape of the outer surface 5004 as described herein above helps anchor the shield 5000 to the tissue margins when inserted into a body orifice, incision site, or other opening. Additionally, the larger diameter shape at the top end 5006 helps provide a cutting board surface for performing manual morcellation and protecting surrounding tissue. For example, a flatter, more planar orientation of the top end 5006 with the inner surface 5002 facing upward and perpendicular or nearly perpendicular to the long axis and the outer surface 5004 facing downward toward the tissue, e.g., facing downward toward the abdominal wall, creates a greater protective overlap or a greater cutting board-like surface. As shown in the variation of Figures 164-167, the outer surface of the band has a concave or curvature along the long axis from the top end 5006 to the bottom end 5008 and extends circumferentially around the guard from the first end 5010 to the second end 5012. The shield 5000 is made of a flexible, 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, where a gap is defined between the first end 5010 and the second end 5012. The gap is approximately 5-10 degrees and has an arc length of approximately 4-6 mm. The rest lumen diameter is approximately 40 mm at the barrel. Because the shield 5000 is elastic and flexible, its lumen diameter can be adjusted by bending and turning the band inwardly to reduce the gap and overlap the first end 5010 and the second end 5012 of the band to reduce the lumen diameter, or by bending or flexing the band outwardly to increase the gap and increase the lumen diameter relative to the rest lumen diameter. From an increased or decreased lumen diameter compared to the rest lumen diameter, the band will tend to spring back toward approximately the rest configuration and rest lumen diameter due to its elastic nature. In one variation, the rest configuration has no gap. As the diameter of the band decreases, the first end 5010 overlaps the second end 5012 forming a spiral shape when viewed from the top or bottom. The outer surface 5004 of the band at the first end 5010 faces at least a portion of the inner surface 5002 at the second end 5012 such that the portion of the band closer to the first end 5010 nests within the portion of the band closer to the second end 5012. To accommodate the nested first end portion of the band, the second end portion is configured to jog outwardly 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 when the bands nest, the inner surface 5002 retains a large inner diameter that is not reduced by the overlapping segments of the band at the location of the overlap, so that the inner surface is substantially flush at the intersection with the location of the overlap, as can be seen in FIG. An inner ridge surface 5016 is formed in the shield 5000 by an outwardly extending step or irregularity in the inner surface of the band that is defined by an increased lumen diameter. The increased lumen diameter extends from the ridge 5016 along a portion of the band's circumference to the second end 5012. The inner ridge 5016 is formed approximately 127 degrees from the second end 5012.An inner ridge 5016 is formed against the inner surface 5002 and extends longitudinally from the top end 5006 to the bottom end 5008 substantially perpendicularly therefrom. The inner ridge 5016 forms a corresponding outer ridge 5018 when the band is molded to create a step at the inner ridge 5016 where the band increases in inner diameter by a segment distance 5014 approximately 127 degrees 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, extending along the longitudinal axis between the top end 5006 and the bottom end 5008.

[0162] The first inner abutment 5020 is formed on the inner surface 5002. A surface of the first inner abutment 5020 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outwardly 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. In the first reduced configuration, when the first end 5010 overlaps the second end 5012 and the outer surface 5004 of the first end 5010 faces and overlaps the inner surface 5002 of the second end 5012, the first end 5010 is configured to contact the first inner abutment 5020 to lock and prevent further reduction in size of the inner diameter. This configuration serves to lock the shield 5000 at a fixed diametric / lateral dimension, with the shield 5000 maintaining some overlap circumferentially around a portion of the circumference of the shield 5000. This locking is particularly useful when the shield 5000 is placed inside a body orifice or incision where tissue forces tend to collapse the central lumen to further reduce the inner diameter. The central lumen serves as a working channel, and the locking occurs when at least a portion of the shield 5000 contacts the first inner abutment 5020. The first inner abutment 5020 is located approximately 30 degrees from the second end 5012. When the first end 5010 contacts the first inner abutment 5020, the inner diameter is approximately 36 mm.

[0163] The shield 5000 further includes a second inner abutment 5022 at a greater distance from the second end 5012. Specifically, the second inner abutment 5022 is located approximately 65 degrees from the second end 5012. The second inner abutment 5022 is formed on the inner surface 5002. A surface of the second inner abutment 5022 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outwardly from the inner surface 5002 along the longitudinal axis between a top end 5006 and a bottom end 5008. The second inner abutment 5022 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 5020 and the second inner abutment 5022 are substantially parallel. When the first end 5010 overlaps the second end 5012 with the outer surface 5004 of the first end 5010 facing the inner surface 5002 of the second end 5012 in the reduced diametric / lateral configuration, the first end 5010 is configured to contact either the first inner abutment 5020 or the second inner abutment 5022 to lock and prevent further reduction in the size of the inner diameter. The second inner abutment 5022, like the first inner abutment 5020, serves to lock the shield 5000 at a fixed diametric / lateral dimension such that the shield 5000 maintains a degree of overlap circumferentially around the outer periphery of the shield 5000. This locking is particularly useful when the shield 5000 is placed within a body orifice or incision where tissue forces tend to collapse the central lumen to further reduce the inner diameter. The central lumen serves as a working channel and locking occurs when at least a portion of the shield 5000 contacts the second inner abutment 5020. 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 sits against the outer surface 5004. A first outer abutment 5024 or receiving area 5024 is formed in the outer surface 5004 to accommodate the first inner abutment 5020.In one variation as shown, the receiving area 5024 includes an abutment formed therein, and in another variation, the receiving area is not configured to have an abutment surface. The first outer abutment 5024 is located approximately 30 degrees from the first end 5010. The first outer abutment 5024 is formed on the outer surface 5004. The surface of the first outer abutment 5024 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends inwardly from the outer surface 5004 along the longitudinal axis between a top end 5006 and a bottom end 5008. The first outer abutment 5024 has a height from 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 5024 and the first and second inner abutments 5020 and 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, locking and preventing further reduction in the size of the inner diameter.

[0164] The shield 5000 further includes a third inner abutment 5026 located at a greater distance from the second end 5012. Specifically, the third inner abutment 5026 is located approximately 100 degrees from the second end 5012. The third inner abutment 5026 is formed on the inner surface 5002. A surface of the third inner abutment 5026 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outwardly from the inner surface 5002 along the longitudinal axis between a top end 5006 and a bottom end 5008. The third inner abutment 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 5020, the second inner abutment 5022, and the third inner abutment 5026 are substantially parallel and approximately equally spaced around the circumference of the inner surface 5002. In the reduced diametric / lateral configuration, when the first end 5010 overlaps the second end 5012 with the outer surface 5004 of the first end 5010 facing and overlapping the inner surface 5002 of the second end 5012, the first end 5010 is configured to contact either the first inner abutment 5020, the second inner abutment 5022, or the third inner abutment 5026 to variably adjust the inner diameter, and then lock and prevent further reduction in the size of the inner diameter. The third inner abutment 5026, as well as the first inner abutment 5020 and the second inner abutment 5022, serve to lock the shield 5000 at a fixed diametric / lateral dimension, so that the shield 5000 maintains some overlap circumferentially around the outer circumference of the shield 5000. This locking is particularly useful when the shield 5000 is placed inside a body orifice or incision where tissue forces tend to collapse the central lumen and further reduce the inner diameter. When the first end 5010 contacts the third inner abutment 5026, the inner diameter is approximately 30 mm. When the first end 5010 contacts the third inner abutment 5024, the first inner abutment 5020 and the second inner abutment 5022 sit against the outer surface 5004.A first outer abutment 5024 is formed on the outer surface 5004 and a second outer abutment or receiving area 5028 is formed on the outer surface 5004 to receive the first inner abutment 5020 and the second inner abutment 5022. In one variation, the receiving area is provided with an abutment surface, and in another variation, the receiving area is sized and configured to receive the inner abutment flush. The second outer abutment 5028 is located approximately 65 degrees from the first end 5010. The second outer abutment 5028 is formed on the outer surface 5004. The surface of the second outer abutment 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 5028 has a height from the outer surface 5004 that is approximately equal to the height of the inner abutment or the thickness of the band material between the inner surface 5002 and the outer surface 5004. The second outer abutment 5028, the first outer abutment 5024 and the first inner abutment 5020, the second inner abutment 5022 and the third inner abutment 5026 are substantially parallel. When the first end 5010 overlaps the second end 5012 such that the first end 5010 contacts the third inner abutment 5026, the first inner abutment 5020 faces and contacts the second outer abutment 5028 and the second inner abutment 5022 faces and contacts the first outer abutment 5020, locking and preventing further reduction in the size of the inner diameter.

[0165] The shield 5000 further includes a third outer abutment 5030 located at a greater distance from the first end 5010 than the second outer abutment 5028. Specifically, the third outer abutment 5030 is located approximately 100 degrees from the first end 5010. The third outer abutment 5030 is formed on the outer surface 5004. The surface of the third outer abutment 5030 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends inwardly from the outer surface 5004 along the longitudinal axis between a top end 5006 and a bottom end 5008. The inward extension of the outer abutment forms a ramp-like surface on the inner surface 5002. The third outer abutment 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 5030 is configured to accommodate and receive the first inner abutment 5020 when the first end 5010 abuts the inner ridge 5016, as shown in FIG. 167. In another variation, the first end 5010 abuts a fourth inner abutment that is not configured as an inner ridge 5016 as described herein. The first inner abutment 5020, the second inner abutment 5022, and the third inner abutment 5026 are substantially parallel. In the reduced diametric / lateral configuration, when the first end 5010 overlaps the second end 5012 with the outer surface 5004 of the first end 5010 facing the inner surface 5002 of the second end 5012, 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 then lock and prevent further reduction in the size of the inner diameter. In one variation, all of the inner abutments, including the inner ridge, are spaced substantially equal distances apart. The first end 5010 is shown contacting the inner ridge 5016 in FIG. 167, creating a shield 5000 with a minimum 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 specifically are received in 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 first end 5010, which is the inner nested segment of the shield 5000, is moved toward the longitudinal axis to disengage the abutting surfaces. The first end 5010 is demarcated by markers 5032, such as tabs, grips with textured surfaces, or contrast colored areas, such as near the top end 5006 or bottom end 5008, to serve as indicators to the user which end of the shield 5000 to nest within the shield 5000 so the abutments interlock accordingly. The markers 5032 also facilitate withdrawal or release of the shield 5000 from the locked configuration by providing textured locations to pull or grip the shield. The markers 5032 can further serve directional purposes to indicate to the user which side of the shield to place up if the shield is asymmetrical along its long axis.

[0166] Although the three inner abutments 5020, 5022, 5026, the three outer abutments 5024, 5028, 5030, and the one inner ridge 5016 have been described with a particular spacing and angular relationship, the invention is not so limited and any number of inner abutments can be provided to provide a variable locking configuration and achieve a desired inner diameter of the working channel. Additionally, while the gap is shown as approximately 8 degrees in the relaxed configuration, the invention is not so limited and the shield 5000 can have a larger gap, a smaller gap, or no gap at all. As discussed above, the shield 5000 is designed such that the first end 5010 serves as a functional locking edge that contacts the abutments, specifically the one or more inner abutments 5020, 5022, 5026 and / or the one or more inner ridges 5016, when variably selecting and fixing the inner diameter. In another variation, the first end 5010 does not serve as a functional edge, but instead serves as a functional locking edge when the outer abutment contacts one or more of the inner abutments 5020, 5022, 5026. And in yet another variation of the shield as 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 contact simultaneously at a fixed diameter location. Each inner abutment forms a protrusion from the triangular shaped sloped inner surface 5002 and the outer abutments form a correspondingly shaped recess or protrusion into the larger triangular shaped sloped outer surface 5004 that is configured to receive the smaller inner abutments such that one or more of the inner abutment surfaces contact one or more of the outer abutments or are simply received within the receiving area without contacting the outer abutments. In one variation, the shape of the inner and outer abutments can further include a friction fit or snap fit configuration to further enhance the locking ability, where features include ridges that provide increased friction lock, ledges or gates.The angled protrusions on the inner surface 5002 facilitate the expansion of the shield from a contracted configuration to an expanded configuration. For example, when inserting the shield into an incision / orifice, the shield 5000 is first curled into a contracted configuration so that it can fit into a small incision / orifice, and then the shield 5000 is anchored into a larger diameter configuration. When anchoring the contracted configuration into a larger diameter configuration, a portion of the outer surface 5004 will ramp up and over the angled protrusions on the inner surface 5002. After the outer surface has overcome the inner surface, the inner abutment will contact the outer abutment to create a first stop or locking position. The shield 5000 can then be further anchored, with the outer surface climbing over the protrusions on the inner surface at the outer abutment to another locked position where the inner and outer abutments contact each other, and so on. The expansion of the shield is therefore performed in a ratchet-like manner, with the diameter dimension gradually increasing in steps between locking interactions with one or more abutments. In one variation, the shield 5000 does not have an outer abutment formed on the outer surface. Instead, the shield 5000 has a receiving area for receiving an inner abutment over which the outer surface overlies to provide a flush locking position, where the locking function occurs when the inner abutment contacts the first end 5010 or, in one variation, contacts one or more outer abutments formed in the receiving area. The receiving area not configured for an abutment formed on the outer surface 5004 can therefore have any shape on the outer surface. The inner surface opposite the receiving area can have an angled or other curved configuration that facilitates movement of the shield between the contracted and expanded configurations. This ramp feature advantageously makes the shield 5000 easier to use, as anchoring the shield to a larger diameter does not require a separate step of mechanically unlocking the locking arrangement. Instead, the shield is simply curled or otherwise moved circumferentially in a ratchet-like manner over the medial projection into a locked position on the adjacent abutment.

[0167] The shield 5000 shown in Figs. 164-167 is adjustable to have four different inner diameter sizes. When inserted inside an incision or body orifice, the shield 5000 can provide protection and follow an incision of approximately 1 inch or less. Of course, larger shields 5000 can be made to be placed inside larger incisions / orifices, such as the vaginal canal. Such shields can also be made to have a longer length than that shown in Figs. 164-167. The shield 5000 provides retraction of tissue at the incision / orifice. When inserted into the incision / orifice, the shield 5000 can be curled into a reduced configuration for insertion into a small incision / orifice, and then the shield 5000 can be anchored into a larger diameter configuration, with multiple locking positions available to customize the locking position of the shield. Thus, the shield 5000 serves the function of retracting, enlarging the incision or orifice while simultaneously enlarging the shield diameter and working channel. The shield 5000 of Figures 164-167 allows the shield to provide retraction and conform to incisions up to approximately 1.5 inches in diameter. The retraction of surrounding tissue increases working space and provides better stability for the user.

[0168] Additionally, the locking mechanism of the shield 5000 is unique because it relies on radial pressure applied externally to the shield 5000 and to the outer surface 5004. Thus, the shield 5000, and in particular the locking mechanism of the shield, in one variation, functions when the shield is inserted into an incision sized equal to or smaller than the inner diameter of the shield's smallest reduced configuration. The surrounding tissue exerts a radial force circumferentially around the outer periphery of the shield 5000, which causes 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 against one or more outer abutments. The surrounding tissue margin exerts a compressive force on the shield. The shield is configured to utilize a force component tangential to the circumference of the shield to move both the inner and / or outer vertical abutments and / or ridges and / or first ends into contact with one or more other abutments or ridges, first ends or other vertical structures, thereby preventing the shield from collapsing while providing a locking feature. The structures of the shield that are perpendicular to the circumferential surface of the abutments / ends / ridges etc. support and reinforce the structure making the shield stronger. Variations of the shield with locking positions and configurations where more than one abutment pair of surfaces are in contact simultaneously for a given locking position make the shield stronger and more able to withstand forces that tend to collapse retracted tissue locations. To further increase the radial strength of the shield while within the tissue opening and retracting tissue and subjecting it to tissue pressure around the shield, any one or more of the abutments / ridges / ends that form the contact surfaces that act as a locking function may extend from at or near the top end 5006 to at or near the bottom end 5008, or at least equal to or greater than 50 percent of the surface length of the shield to provide strength and substantially uniform reinforcement from top to bottom along the length of the shield.Tissue pressure on the shield while it is positioned within the incision / orifice forces the leading edge and outer abutments into the corresponding inner abutments and also allows the overlapping surfaces of the shield to be positioned flush within the shield due to the ridges and steps formed in the shield, the distance between which is equal to the width of the shield wall. Since the shield is shaped and biased toward the larger resting configuration, the shield configured in the abutting reduced configuration in the absence of tissue pressure on the shield will not remain in the reduced and locked configuration. Thus, the lock, in one variation, is a living lock, requiring tissue pressure to effect the locked configuration. Tissue pressure at the incision / orifice cooperate to bring the abutment surfaces into and hold them in the locked configuration. In use, the shield is positioned from the resting configuration to the reduced configuration by first closing the gap and bringing the first end of the band into an overlapping configuration with at least a portion of the second end of the band. The overlap is increased by curling down the band to further reduce the inner diameter to a size that fits within the incision / orifice. The shield is inserted into the incision / orifice and released inside the incision / orifice and is subjected to pressure from the surrounding tissue, either caused by the incision / orifice being smaller in diameter than the reduced configuration of the shield, or caused by the shield increasing in size by anchoring from the reduced configuration. The shield is curled back to increase the inner diameter of the shield. The increase in inner diameter tends to retract the tissue at the edges of the incision / orifice. The retraction of the tissue increases the biasing force that the tissue exerts against the shield. Reducing the amount of overlap of the shield causes the abutments to ratchet into successive locked positions where one or more abutments contact each other or an end or ridge. The contact with the abutments prevents the shield from collapsing and secures the inner diameter. When viewed from above along the long axis of the shield, the shield forms a spiral shape in a plane perpendicular to the long axis when in the collapsed configuration, and when in the resting configuration, the shield forms an open circle or an open ellipse, in one variation.In another variation, the first end of the shield slightly overlaps the second end of the shield. The locking mechanism works in conjunction with tissue pressure to anchor the shield to the incision / orifice. With the lock, an aggressive C-shaped curve of the outer surface is not necessary to aid in anchoring the shield into the incision / orifice. In the absence of the lock, forcing the lower flange of the aggressive C-shaped outer surface into the incision / orifice like a wedge and resting the upper flange against the tissue surface helps anchor the shield to the patient. The locking mechanism advantageously allows the working channel and inner diameter to be maximized without being reduced by an aggressive C-shaped curve to the sidewalls of the band. In one variation, the shield has no curved profile or only a very slight curved profile to maximize the inner diameter, relying more on the locking mechanism to anchor the shield to the patient. The outer step at the second end of the band further maximizes the inner diameter where one portion of the band overlaps another portion of the band, creating a uniform, flush inner diameter instead of a reduced inner diameter at the overlap. In one variation, the shield does not have an outer abutment, but instead has a receiving area that is sized and configured to receive the inner abutment when the shield is spiraled and overlapped with the inner abutment. The receiving area prevents the overlapped band from buckling inwardly toward the central lumen. Instead, the inner abutment is received within the receiving area, maximizing the inner diameter and creating a flush band arrangement around the inner diameter, even at the band overlap. In the most reduced configuration, where the shield has the smallest inner diameter, the first end contacts the inner ridge and all inner abutments are received within the receiving area or contact the corresponding outer abutments.

[0169] 168, another shield 5000 according to the present invention is shown, with like numbers being used to indicate like parts. The first end 5010 includes a protrusion 5034 sized and configured 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 shown in FIG. 168, the slot 5036 is oriented substantially vertically, and the slot 5034 is curved to follow the curvature of the band of the shield. Although one slot 5036 is shown, multiple slots 5036 can be provided to provide variability in the locking diameter.

[0170] 169-170, there is another variation of a locking shield 5000. The shield 5000 includes a first end 5010 configured to slide into a slot 5036 formed in a second end 5012. A plurality of slots 5036 are provided to provide variability in the locking diameter. Each slot 5036 is substantially C-shaped to form a tang 5038 behind which the first end 5010 is inserted to fix the inner diameter. The shield 5000 is unlocked by increasing the diameter by pulling the interlocking segments of the bands apart.

[0171] 171, there is another variation of a shield 5000 with a locking mechanism. The shield 5000 includes one or more longitudinal slots 5036 formed in the second end 5012. Providing multiple slots 5036 gives the shield 5000 variability in the locked position. The first end 5010 includes a protrusion 5034 having an outwardly extending hook 5040 sized and configured to be received within any one of the slots 5036. The hook 5040 abuts against the slot 5036 opening to inhibit contraction or expansion of the inner diameter. The lock is released by bending the first end 5010 inwardly to disengage the hook 5040 from the slot 5036 opening.

[0172] 172-174, another variation of a shield 5000 having a locking mechanism is shown. The shield 5000 includes a first end 5010 having one or more holes 5042 provided therein. The holes 5042 are provided to provide variable locking positions along the band to adjust the inner diameter and lock it in a desired position. The second end 5012 of the shield 5000 includes a protrusion 5034. The protrusion 5034 includes a circular head connected to a neck portion 5044. The protrusion 5034 extends radially inward from the inner surface 5002 of the band. Each hole 5042 has two portions. The first portion of the hole 5042 includes an opening shaped to correspond to the head of the protrusion 5034 and is sized to allow the head of the protrusion 5034 to pass through the hole 5042, as shown in FIG. 174, the projection 5034 then moves into the second portion of the hole 5034 which forms a channel for the neck portion 5044 and a restraint for the head portion such that when the projection 5034 is inside the second portion of the hole 5034, the head portion cannot be removed unless the head portion is aligned with and passed through the first portion of the hole 5034. The slot-lock secures the head portion of the projection 5034 of the second portion 5012 into one of the holes 5042 along the first end 5010, fixing and locking the inner diameter and preventing it from expanding or contracting in size.

[0173] 175, another variation of a shield 5000 having a locking mechanism is shown. The lock includes a protrusion 5034 extending outwardly from the outer surface 5004 near the first end 5010. The protrusion 5034 is longitudinally oriented. The second end 5012 includes one or more correspondingly shaped longitudinally oriented slots 5036. The multiple slots 5036 are provided for variability in adjustment of the size and inner diameter of the shield 5000. The first end 5010 is bent inwardly to nest inside the second end 5012, causing the shield 5000 to spiral to a smaller inner diameter. When a desired inner diameter for a particular surgical purpose is achieved, the protrusion 5034 is aligned with the desired slot 5036 for the desired inner diameter and the protrusion 5034 is inserted into the slot 5036. The projections 5034 abut the slots 5036 to prevent the size and inner diameter of the shield 5000 from expanding or contracting, thereby locking the inner diameter of the shield 5000 in a desired configuration. To unlock the shield 5000, the projections 5034 are pushed back out of the slots 5036 by bending the first end 5010 inward or bending the second end 5012 outward to release the projections 5034 from the slots 5036. In the unlocked configuration, the size of the inner diameter can be reduced so that it can...

Claims

1. 1. A surgical shield for insertion into and protection of an orifice of a patient, comprising: a guard portion formed of a cut resistant material, the guard portion having a generally tubular shape having inner and outer surfaces defining a thickness therebetween and defining a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end; a batten having a reinforcing portion connected to a handle portion, the reinforcing portion connected to the guard portion and extending along the longitudinal axis of the guard portion, the handle portion being located at the proximal end of the guard portion and extending away from the proximal end of the guard portion; A surgical shield comprising:

2. 1. A surgical shield for insertion into and protection of an orifice of a patient, comprising: a guard portion made of a cut resistant material, the guard portion having a generally tubular shape defining a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end, the guard portion having a transverse axis perpendicular to the longitudinal axis; 11. A surgical shield, comprising: a distal opening that lies in a distal plane that is angled with respect to the longitudinal axis to facilitate insertion of the distal end of the shield into an orifice of the patient.

3. providing a shield having a guard portion having an expanded state and a contracted state, said guard portion being made of a flexible material biased to return to said expanded state, said guard portion being generally tubular in shape defining a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end; placing the guard portion in a collapsed state; inserting the shield into the orifice while in a contracted state; releasing the shield from the contracted condition such that it expands toward the expanded condition and abuts the orifice; A method comprising:

4. providing a shield having a guard portion made of a flexible material, the guard portion being generally tubular in shape defining a lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end, the shield further including a batten removably connected to the guard portion, the batten being relatively stiffer than the guard portion, the shield having a reinforcement portion connected to a handle portion, the reinforcement portion extending along the longitudinal axis of the guard portion, the handle portion being located at the proximal end of the guard portion and extending away from the proximal end of the guard portion; connecting the batten to the guard portion; inserting the shield into a patient's orifice while the batten is connected to the guard portion; A method comprising:

5. 10. The surgical shield of claim 9, wherein the guard portion includes at least one channel defined between the outer surface and the inner surface, the channel having an opening at the proximal end, and the reinforcing portion of the batten is located within the channel.

6. 10. A surgical shield according to any one of the preceding claims, wherein the handle portion is angled relative to the reinforcement portion.

7. 10. A surgical shield according to any one of the preceding claims, wherein the batten is removable from the channel.

8. 2. The surgical shield of any preceding claim, wherein the handle portion extends away from the longitudinal axis.

9. 10. A surgical shield according to any one of the preceding claims, characterized in that the battens are L-shaped.

10. 10. A surgical shield according to any one of the preceding claims, wherein the battens are located on an upper portion of the guard portion, the upper portion of the guard portion facing in a forward direction towards the patient.

11. 10. A surgical shield according to any one of the preceding claims, wherein the battens are located at a bottom of the guard portion, the bottom of the guard facing posteriorly towards the patient.

12. 10. A surgical shield according to any one of the preceding claims, characterized in that the guard portion is made of a flexible material.

13. 10. A surgical shield according to any one of the preceding claims, wherein the battens are relatively stiffer than the guard portions.

14. 10. The surgical shield of any one of the preceding claims, wherein the guard portion includes a bead having an enlarged thickness around the distal opening.

15. 2. A surgical shield according to any preceding claim, wherein the guard portion includes a depending flange portion at the proximal end.

16. 10. The surgical shield of any one of the preceding claims, wherein the guard portion has an expanded and a contracted state, the guard portion being made from a cut-resistant, flexible material biased to return to the expanded state.

17. 10. The surgical shield of any one of the preceding claims, wherein the distal plane is parallel to the transverse axis.

18. 10. The surgical shield of any one of the preceding claims, wherein a distal insertion angle of the tip is defined by the distal planar projection and the guard portion relative to a plane perpendicular to the transverse axis.

19. 2. The surgical shield of any one of the preceding claims, wherein the proximal opening lies in a proximal plane angled with respect to the longitudinal axis and forms a flange at the proximal end.

20. 10. The surgical shield of any one of the preceding claims, wherein the proximal plane is parallel to the transverse axis.

21. 10. The surgical shield of any one of the preceding claims, wherein the distal and proximal planes are substantially parallel.

22. 10. The surgical shield of claim 1, wherein the lumen has an elongated cross-section when viewed in a plane perpendicular to the longitudinal axis at the proximal end and an elongated cross-section when viewed in a plane perpendicular to the longitudinal axis at the distal end.

23. 2. The surgical shield of any one of the preceding claims, wherein the lumen has a circular cross-section between the distal and proximal ends.

24. 10. A surgical shield according to any one of the preceding claims, further comprising a batten connected to said guard portion, said batten being stiffer than said guard portion.

25. 10. The surgical shield of claim 9, wherein the batten has a reinforcement portion connected to a handle portion, the reinforcement portion connected to the guard portion, the handle portion being located at the proximal end and extending away from the proximal end of the guard portion.

26. 10. The surgical shield of any one of the preceding claims, further comprising a bead around the distal opening.

27. 10. The surgical shield of any one of the preceding claims, further comprising a bead around the proximal opening.

28. 10. The surgical shield of any one of the preceding claims, wherein the orifice is a vagina and the guard is sized and configured such that when inserted, the bead is located below the pubic bone and the proximal opening is outside the vagina.

29. 10. A surgical shield according to any one of the preceding claims, wherein the guard portion is substantially hourglass shaped.

30. 10. The method of claim 9, wherein the shield further comprises a batten having a reinforcing portion connected to a handle portion, the reinforcing portion being connected to the guard portion and extending along the longitudinal axis of the guard portion, the handle portion being located at the proximal end of the guard portion and extending away from the longitudinal axis.

31. 10. The method of any one of the preceding claims, wherein the guard portion includes an outer surface and an inner surface defining a thickness therebetween, the guard portion further including a channel defined between the outer surface and the inner surface, the channel having an opening at a proximal end sized and configured to receive the reinforcing portion, the reinforcing portion of the batten located within the channel.

32. 10. A method according to any one of the preceding claims, further comprising the step of inserting a batten into a channel of the guard part prior to the step of inserting the shield into the orifice.

33. 10. A method according to any one of the preceding claims, characterized in that the step of inserting the shield into the orifice comprises gripping the handle portion of the batten.

34. 10. The method of claim 9, further comprising the step of removing the batten from the channel after the step of inserting the shield into the orifice and while the shield is located within the orifice.

35. 10. A method according to any one of the preceding claims, wherein the guard portion has an expanded and a contracted state, the guard portion being made from a flexible material biased to return to the expanded state.

36. 10. A method according to any one of the preceding claims, comprising the step of removing the batten whilst the shield is located within the orifice.

Images