Redeployable Tissue Recovery System

Abstract

To provide a tissue retrieval device redeployable to obtain multiple tissue specimens in a single procedure.SOLUTION: A tissue retrieval system including a tissue retrieval bag deployable by an actuator from an introducer and suspended in an open configuration by support arms can be serially redeployed between a partially or fully stowed configuration and a first deployed configuration to be used in procedures to collect multiple samples. The system can include defeasible proximal and distal stop mechanisms to limit movement of the actuator for serial redeployment. The tissue retrieval system can include: a retention latch to couple a bead of the tissue retrieval bag to the actuator with the retrieval bag in a first deployed position; and a user-selectable deployment release to allow deployment of the retrieval bag to a fully deployed position where it is released from the actuator. A bead stop is positioned to engage the introducer to prevent reintroduction of the bead and the bag into the introducer once the bag has been fully deployed.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority and the benefit thereof to U.S. Provisional Patent Application No. 62 / 936,128, entitled "Redeployable Tissue Retrieval System," filed on November 15, 2019, which is incorporated herein by reference in its entirety.

[0002] This application generally relates to devices and methods for capturing and retrieving tissue from body cavities, and particularly to specimen retrieval bag devices.

Background Art

[0003] Laparoscopic surgery is typically performed through a trocar that provides access into the abdominal cavity through the abdominal wall. In some surgeries, tissue located within the abdominal cavity is cut and removed from the body. However, the removal of such tissue from the body can prove difficult due to the restricted nature inherent in laparoscopic surgery and the available laparoscopic surgical instruments. For example, it may be desirable to introduce all surgical instruments through a single laparoscopic port having a relatively small size in order to reduce invasiveness to the patient. Also, the tissue to be removed may include infected or cancerous masses or organs, as well as blood, bile, and other fluids, all of which are herein referred to as tissue, and these may present infection problems or other complications if left within the body.

[0004] It is desirable to grip, capture, hold, and enclose these tissues while they are within the body cavity and then remove the enclosed tissue through a trocar or incision. As rapid as possible tissue confinement with minimal disruption of the surgical site is also desirable. Generally, large and complex devices have several drawbacks and, particularly due to the limited space in the operating room and the access ports within the body cavity, lack optimal efficiency, so it is generally considered desirable to have a small and single unit device.

Prior Art Documents

[0005] [Patent Document 1] U.S. Patent No. 8,721,658 [Patent Document 2] U.S. Patent No. 9,033,995 [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] In certain procedures, it may be desirable to obtain multiple tissue samples from a body cavity in a single procedure for further analysis. For example, in patients being treated for cancer, serial removal of lymph nodes is a common practice to determine the extent of cancer spread within the patient or the recurrence of cancer. To ensure proper identification of lymph nodes from a specific body region, it may be important to remove lymph nodes sequentially from the patient, sometimes one at a time, to ensure accurate determination of the cancer stage. The surgeon typically begins with the removal of the sentinel lymph node, which is the lymph node closest to the tumor, and then proceeds to other lymph nodes in the surrounding region. In some procedures, each lymph node removed from the patient is immediately analyzed for the presence of cancer during surgery by a pathologist before the removal of the next lymph node, in order to minimize the number of lymph nodes removed from the patient. That is, it may be desirable that the tissue retrieval device be redeployable to obtain multiple tissue samples in a single procedure. [Means for solving the problem]

[0007] A tissue recovery system is provided according to a certain embodiment. The tissue recovery system comprises a tubular introducer, an actuator, a retaining latch, a pair of support arms, a bead, and a tissue recovery bag. The tubular introducer has a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The actuator is longitudinally slidable within the lumen of the introducer. The actuator has a proximal end and a distal end. The retaining latch is positioned at the distal end of the actuator. The pair of support arms extends from the distal end of the actuator. The bead is positioned distal to the retaining latch. The bead is releasably coupled to the retaining latch. The tissue recovery bag is coupled to the bead and releasably coupled to the support arms.

[0008] A tissue recovery system is provided herein by certain embodiments. The tissue recovery system comprises a tubular introducer, a handle assembly, an actuator, and a tissue recovery bag. The tubular introducer has a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The handle assembly is positioned at the proximal end of the introducer. The actuator is longitudinally slidable within the lumen of the introducer. The actuator has a proximal end and a distal end. The tissue recovery bag is releasably coupled to the distal end of the actuator. The handle assembly includes a proximal stop mechanism and a distal stop mechanism such that the actuator is repeatedly longitudinally slidable between a proximal position in which the tissue recovery bag is retracted into the distal end of the introducer and a first deployed position in which the tissue recovery bag is deployed from the distal end of the introducer and coupled to the actuator. [Brief explanation of the drawing]

[0009] [Figure 1A] This is a perspective view of an embodiment of a tissue recovery system in which the tissue recovery bag is in a first deployed configuration. [Figure 1B] Figure 1A is a side view of the tissue recovery system. [Figure 2]This is a perspective view of an embodiment of a tissue recovery system in which a tissue recovery bag is included in the storage configuration. [Figure 3] Figure 1 is a top view of the tissue recovery system, in which the tissue recovery bag is deployed and positioned at the surgical site via an access port. [Figure 4] Figure 1A is a top view of the tissue retrieval system, in which the tissue retrieval bag is positioned at the surgical site via an access port and has a re-deployable tightening configuration. [Figure 5] Figure 1A is a top view of the tissue retrieval system, in which the tissue retrieval bag is fully deployed and positioned at the surgical site via an access port. [Figure 6A] Figure 1A is a top view of the tissue retrieval system, in which the tissue retrieval bag is positioned at the surgical site via an access port and is in a fully deployed and tightened configuration. [Figure 6B] Figure 1A is a detailed diagram of the tissue retrieval system, in which the tissue retrieval bag is positioned at the surgical site through an access port and is in a fully deployed and tightened configuration with a cord loop embodiment. [Figure 6C] Figure 1A is a detailed view of the tissue retrieval system, in which the tissue retrieval bag is positioned at the surgical site through an access port and is in a fully deployed and tightened configuration with another embodiment of a cord loop. [Figure 7] Figure 1A is a perspective view of an embodiment of a bead for a tissue recovery system. [Figure 8] Figure 1A is a perspective view of an embodiment of a retaining latch for a tissue recovery system. [Figure 9] Figure 1A is a perspective view of an embodiment of a bead stop for a tissue recovery system. [Figure 10] Figure 1A is a partially cutaway bottom view of the tissue recovery system, showing the bead, retaining latch, and bead stop, with the tissue recovery bag in the first deployed configuration. [Figure 11] Figure 1A is a cross-sectional side view of the bead, retaining latch, and bead stop of the tissue recovery system in the first deployment configuration, where the tissue recovery bag is located. [Figure 12]Partial cutaway bottom view of the guide bead, retaining latch, and bead stop of the tissue collection system of FIG. 1A with the tissue collection bag in a fully deployed configuration. [Figure 13] Cross-sectional side view of the guide bead, retaining latch, and bead stop of the tissue collection system of FIG. 1A with the tissue collection bag in a fully deployed configuration. [Figure 14] Cross-sectional side view of the guide bead, retaining latch, and bead stop of the tissue collection system of FIG. 1A with the tissue collection bag in a fully deployed configuration and the retaining latch disengaged from the guide bead when the actuator is retracted. [Figure 15] Cross-sectional side view of the guide bead, retaining latch, and bead stop of the tissue collection system of FIG. 1A with the tissue collection bag in a fully deployed configuration and the retaining latch completely disengaged from the guide bead when the actuator is retracted. [Figure 16] Perspective view of the actuator post of the tissue collection system of FIG. 1A. [Figure 17] Top view of an embodiment of the handle assembly of the tissue collection system of FIG. 1A with the actuator retracted to a position corresponding to the tissue collection bag in a redeployable tightened configuration. [Figure 18] Cross-sectional side view of the handle assembly of FIG. 17 with the actuator retracted to a position corresponding to the tissue collection bag in a redeployable tightened configuration. [Figure 19] Cross-sectional side view of a portion of the handle assembly of FIG. 17 detailing the blocking position of the actuator post with the actuator retracted to a position corresponding to the tissue collection bag in a redeployable tightened configuration. [Figure 20] Top view of an embodiment of the handle assembly of the tissue collection system of FIG. 1A with the actuator advanced to a position corresponding to the tissue collection bag in a fully deployed configuration. [Figure 21] Cross-sectional side view of the handle assembly of FIG. 20 with the actuator advanced to a position corresponding to the tissue collection bag in a fully deployed configuration. [Figure 22]FIG. 20 is a cross-sectional side view of a portion of a handle assembly that details the intrusion position of an actuator post that has advanced the actuator to a position corresponding to the tissue collection bag in the fully deployed configuration. [Figure 23A] FIG. 3 is a perspective view of an embodiment of a deployment release button for use in conjunction with the handle assembly of the tissue collection system of FIG. 1A. [Figure 23B] FIG. 6 is a perspective view of another embodiment of a deployment release button for use in conjunction with the handle assembly of the tissue collection system of FIG. 1A. [Figure 24A] FIG. 9 is a perspective view of an embodiment of an actuator handle for use in conjunction with the handle assembly of the tissue collection system of FIG. 1A. [Figure 24B] FIG. 12 is a perspective view of another embodiment of an actuator handle for use in conjunction with the handle assembly of the tissue collection system of FIG. 1A. [Figure 25A] FIG. 15 is a partial cutaway top view of the handle assembly of the tissue collection system of FIG. 1A with the actuator handle advanced to a position corresponding to the tissue collection bag in the first deployed configuration. [Figure 25B] FIG. 18 is a partial cutaway bottom view of the handle assembly of the tissue collection system of FIG. 1A with the actuator handle advanced to a position corresponding to the tissue collection bag in the first deployed configuration. [Figure 26A] FIG. 21 is a cross-sectional end view of the handle assembly of the tissue collection system of FIG. 1A with the actuator handle advanced to a position corresponding to the tissue collection bag in the first deployed configuration and the deployment release button of FIG. 23A in the blocking position. [Figure 26B] FIG. 24 is a cross-sectional end view of the handle assembly of the tissue collection system of FIG. 1A with the actuator handle advanced to a position corresponding to the tissue collection bag in the first deployed configuration and the deployment release button of FIG. 23B in the blocking position. [Figure 27A] FIG. 27 is a partial cutaway top view of the handle assembly of the tissue collection system of FIG. 1A with the actuator handle advanced to a position corresponding to the tissue collection bag in the fully deployed configuration. [Figure 27B]Figure 24B is a partially cutaway bottom view of the handle assembly of the tissue recovery system in Figure 1A, with the actuator handle advanced to a position corresponding to the tissue recovery bag in the fully deployed configuration. [Figure 27C] Figure 24B is a partially cutaway bottom view of the handle assembly of the tissue recovery system in Figure 1A, with the actuator handle retracted to a position corresponding to the tissue recovery bag in a fully tightened configuration. [Figure 28A] Figure 1A is a cross-sectional end view of the handle assembly of the tissue recovery system, with the actuator handle shown in Figure 24A advanced to the position corresponding to the tissue recovery bag in the fully deployed configuration, and the release button shown in Figure 23A in the pressed position. [Figure 28B] Figure 1A is a cross-sectional end view of the handle assembly of the tissue recovery system, with the actuator handle shown in Figure 24B advanced to the position corresponding to the tissue recovery bag in the fully deployed configuration, and the release button shown in Figure 23B in the pressed position. [Figure 28C] Figure 24B is a cross-sectional side view of the handle assembly of the tissue recovery system shown in Figure 1A, with the actuator handle retracted to a position corresponding to the tissue recovery bag in a fully tightened configuration. [Figure 29] This is a partially cutaway bottom view of an embodiment of a retaining latch, bead stop, and guide bead for use in a tissue recovery system in which the actuator position is advanced to correspond to a tissue recovery bag in a fully deployed configuration. [Figure 30] Figure 29 is a cross-sectional side view of an embodiment of the retaining latch, bead stop, and guide bead. [Figure 31A] This is a perspective view of an embodiment of a bead stop for use in a tissue recovery system. [Figure 31B] This is a perspective view of an embodiment of a bead stop for use in a tissue recovery system. [Figure 32A] Figure 31A is a cross-sectional view of the bead stop. [Figure 32B] Figure 31B is a cross-sectional view of the bead stop. [Figure 33]This is a perspective view of an embodiment of a retaining latch for use in a tissue recovery system. [Figure 34] Figure 33 is a cross-sectional side view of the retaining latch engaged with the guide bead of the tissue retrieval system, which has advanced the actuator to the first deployment position. [Figure 35] Figure 33 is a cross-sectional side view of the retaining latch engaged with the guide bead of the tissue retrieval system when the actuator is advanced to the fully deployed position. [Figure 36] This is an end view of a snap ring for use with a certain embodiment of a guide bead in a tissue recovery system. [Figure 37] Figure 36 is a partially cutaway bottom view of an embodiment of a tissue recovery system having a snap ring with the actuator advanced to the fully extended position. [Figure 38] Figure 37 is a cross-sectional side view of the tissue recovery system. [Figure 39] This is a partially cutaway side view of the distal end of an embodiment of a tissue retrieval system having a retaining latch in which the actuator is positioned in a fully extended position. [Figure 40] Figure 39 is a cross-sectional top view of the tissue recovery system. [Figure 41] Figure 39 is a cross-sectional top view of the tissue retrieval system, showing the actuator partially retracted and the retaining latch detached from the guide bead. [Figure 42] Figure 39 is a cross-sectional top view of the tissue retrieval system, showing the actuator pulled back and the retaining latch detached from the guide bead. [Figure 43] This is an exploded perspective view of an embodiment of a guide bead for a tissue recovery system. [Figure 44] Figure 43 is a perspective view of the guide bead. [Figure 45] This is a cross-sectional side view of the guide bead shown in Figure 43, which is attached to the tissue recovery bag. [Figure 46] This is an exploded perspective view of an embodiment of a guide bead for a tissue recovery system. [Figure 47] Figure 46 is a perspective view of the guide bead. [Figure 48] This is a cross-sectional side view of the guide bead shown in Figure 46, which is attached to the tissue recovery bag. [Figure 49] This is an exploded perspective view of an embodiment of a guide bead for a tissue recovery system. [Figure 50] Figure 49 is a perspective view of the guide bead. [Figure 51] This is a cross-sectional side view of the guide bead shown in Figure 49, which is attached to the tissue recovery bag. [Figure 52] This is an exploded perspective view of an embodiment of a guide bead for a tissue recovery system. [Figure 53] Figure 52 is a perspective view of the guide bead. [Figure 54] Figure 52 is a perspective view of the guide bead portion of the guide bead. [Figure 55] Figure 54 is a side view of the guide bead portion. [Figure 56] This is a partial cutaway bottom view of a handle assembly for a tissue retrieval system, with the actuator in a first deployed position. [Figure 57] Figure 56 is a partially cutaway bottom view of the handle assembly, with the actuator retracted to its proximal position to position the tissue retrieval bag into the storage configuration. [Figure 58] Figure 56 is a detailed view of the latching claw of the handle assembly, with the actuator retracted to its proximal position to position the tissue retrieval bag into the storage configuration. [Figure 59] Figure 56 is a partially cutaway bottom view of the handle assembly with the actuator in the fully extended position. [Figure 60] Figure 56 is a partially cutaway bottom view of the handle assembly with the actuator retracted to position the tissue retrieval bag in the fully deployed and tightened position. [Figure 61] Figure 56 is a detailed view of the latching claws of the handle assembly, with the actuator retracted to position the tissue retrieval bag in the fully deployed and tightened position. [Figure 62] This is a perspective view of an embodiment of an actuator handle for use in a tissue recovery system. [Figure 63] Figure 62 is a top view of a handle assembly for a tissue recovery system, including an actuator handle, in which the actuator handle is positioned to correspond to a tissue recovery bag in a first deployment configuration. [Figure 64] Figure 63 is a cross-sectional side view of the handle assembly. [Figure 65] This is a side view of an embodiment of the tissue recovery bag at the distal end of an embodiment of a tissue recovery system in which the tissue recovery bag has been deployed to a first deployment position. [Figure 66] This is a side view of a tissue recovery bag with a re-deployable tightening configuration. [Modes for carrying out the invention]

[0010] An exemplary embodiment of the tissue recovery system 10 is illustrated with reference to Figures 1A and 1B. The exemplary tissue recovery system can be used to confine and retrieve a tissue specimen excised from a body cavity. Certain embodiments of the tissue recovery system are described in U.S. Patent No. 8,721,658, entitled “TISSUE RETRIEVAL SYSTEM” and U.S. Patent No. 9,033,995, entitled “SINGLE INCISION LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM”. Each of these patents is incorporated herein by reference in its entirety.

[0011] In various embodiments, the tissue retrieval system 10 described herein provides a versatile, redeployable retrieval system that can be used to sequentially confine and retrieve multiple small tissue specimens without removing the retrieval bag from the device during a surgical procedure, while simultaneously enabling the extraction of larger tissue specimens by tightening the retrieval bag and then detaching it from the introducer. In some procedures, the surgeon may only need the skill to sequentially confine and retrieve small specimens from the patient. In some procedures, the surgeon may need the skill to sequentially confine and retrieve multiple small tissue specimens, and in this case, also need to confine and extract larger specimens. In other procedures, the surgeon may only need to confine and extract larger tissue specimens. Since the retrieval systems described herein meet many different surgical requirements, it is considered that hospitals or surgical centers using these systems can limit the number of retrieval system models stocked relative to their surgical needs.

[0012] The exemplary tissue recovery system can be preferably used in a certain procedure for sequentially trapping and withdrawing multiple excised small tissue specimens. Advantageously, certain embodiments of the tissue recovery system described herein can allow the use of a single recovery system for sequentially removing multiple lymph nodes during the procedure.

[0013] Referring to Figures 1A and 1B, in certain embodiments, the tissue recovery system 10 includes a recovery bag 20 that provides a receptacle for a tissue sample at its distal end. The recovery bag 20 may have an open end and a closed end opposite it. The recovery bag 20 may further include a cuff 21 formed at the open end to receive a pair of support arms 40 for suspending it, and a cord loop for selectively tightening the open end of the recovery bag. In various embodiments, the recovery bag may be formed from a ripstop nylon and polyurethane laminate, polyurethane, or a combination of both materials. For example, the recovery bag may be formed from a ripstop nylon and polyurethane laminate and may include a polyurethane reinforcement at the tip of the recovery bag to increase the burst strength and puncture resistance of the recovery bag. The reinforcement may consist of ripstop nylon or a ripstop nylon and polyurethane laminate. As an alternative to the ripstop nylon and polyurethane laminate, the ripstop nylon may be coated with polyurethane.

[0014] In the procedure for collecting multiple small specimens, after inserting the tissue specimens into the collection bag, the collection bag 20 can be reversibly closed to prevent leakage of its contents during withdrawal from the body cavity and to further prevent contamination of the body cavity and its walls. With the collection bag withdrawn from the body cavity, it can be opened again to remove the tissue specimens, which can then be sent to a pathologist for analysis. The collection bag can then be fully retracted into the introducer tube and redeployed into the patient's body for containment and withdrawal of the next target tissue specimen.

[0015] The tissue recovery system 10 can be used in procedures for removing large tissue specimens, such as the gallbladder or kidney, from a body cavity. In these procedures, the recovery bag 20 can be completely tightened and closed and detached from the system for subsequent retraction of the recovery bag 20 through the body wall. In some procedures, such as those related to the resection of cancerous tissue, it may be desirable to first remove a small tissue specimen, such as a lymph node, and then remove a larger tissue specimen. In this case, the tissue recovery system 10 allows the recovery bag to be reversibly closed for successive removal of smaller tissue specimens, and then the recovery bag to be completely tightened and closed and detached for removal of an even larger tissue specimen.

[0016] Referring to Figures 1A to 6A, certain embodiments of a tissue recovery system 10 in various configurations for use in procedures for recovering multiple tissue specimens in a single step are shown. Referring to Figures 1A and 1B, a tissue recovery system 10 in a first deployment condition is illustrated. In the illustrated embodiments, the tissue recovery system comprises an introducer 3 and an actuator 7 or actuation rod. In one embodiment, the introducer 3 comprises a tubular configuration having a hollow lumen and a handle assembly 5 extending from the proximal end of the introducer 3. In some embodiments, the introducer 3 can be sized and configured for placement through a standard-sized trocar. For example, it may be desirable for the introducer 3 to be sized as a 5 mm laparoscopic surgical instrument to be introduced through a relatively small diameter trocar, such as a 5-7 mm trocar. In other embodiments, the introducer 3 can be sized as a 10 mm or 12 mm laparoscopic surgical instrument. In some embodiments, the introducer 3 can have a non-standard size for application at a specific location. In some embodiments, the tissue retrieval system 10 may include a relatively long introducer, such as a 45 cm long introducer 3, to improve access to the surgical site.

[0017] In exemplary embodiments, the handle assembly 5 may include a small handle member that can be adapted for adjacent placement with other surgical instruments within a single-port laparoscopic surgical site. Thus, in some embodiments, the tissue retrieval system is intended for use during single-incision laparoscopic procedures. In other embodiments, the handle assembly may include a pair of finger loops or grips formed with or attached to the handle assembly 5 that can be used to hold or stabilize the introducer 3 as desired.

[0018] In an exemplary embodiment 10 of the tissue retrieval system, the introducer 3 generally has an open proximal and distal end to facilitate access to a hollow lumen. As shown, the actuator 7 extends from its open proximal end into the hollow lumen and is slidably movable within the hollow lumen of the introducer 3. Referring to Figure 2, the actuator rod can be retracted to the proximal position for insertion into the surgical site through an access port such as a trocar. When the actuator 7 is in the proximal position, the retrieval bag 20 is positioned and housed within the hollow lumen of the introducer 3. In one embodiment, the actuator 7 has a thumb loop-like handle extending from its proximal end. This handle provides a grippable portion of the device for controlling or facilitating the movement of the actuator 7 relative to the introducer 3 between the proximal position (shown in Figure 2) and a first deployment condition of the tissue retrieval system (shown in Figure 1A).

[0019] Referring to Figures 3 to 6A, an exemplary method for using the above-described exemplary embodiment 10 of the tissue recovery system to recover a tissue sample at the surgical site is shown. In certain embodiments, the tissue recovery system may be provided in either a stowed configuration (Figure 2) or a first unfolded configuration (Figure 1A). In some embodiments, in order to ensure that the recovery bag 20 maintains its original configuration and unfolds easily during surgical use, it may be desirable that the tissue recovery system 10 be packaged with the recovery bag 20 unfolded from the distal end of the introducer tube. During clinical use, an access device such as a trocar 100, which comprises a trocar cannula and a trocar sealing housing, is initially placed through the body wall W with the trocar cannula positioned to traverse the body wall W. If the tissue recovery system 10 is provided in the first unfolded configuration, a nurse or surgeon configures the tissue recovery system into a stowed configuration (Figure 2) by fully retracting the recovery bag 20 into the introducer 3 tube by pulling the actuator 7 proximal to position the actuator rod in the proximal position. Next, the tissue retrieval system 10 can be inserted into the trocar sealing housing and trocar cannula until the distal end of the introducer 3 tube extends beyond the distal end of the trocar cannula. Then, by advancing the actuator distally to the first deployment position (Figure 3), the retrieval bag 20 is deployed from the introducer 3 into the body cavity.

[0020] Continuing with the reference to Figure 3, in the first deployment configuration, with the bag extending into the body cavity, the retrieval bag 20 is suspended and held in an open position by two support arms 40 extending into a cuff at the open end of the retrieval bag. In the illustrated embodiment, the retrieval bag includes a bead 50 attached to the proximal portion of the cuff through which the support arms 40 extend. In the first deployment position, the exemplary embodiment of the tissue retrieval system includes a retaining latch coupled to the distal end of the actuator 7 and engaged with the bead 50. Advantageously, the retaining latch allows the surgeon to selectively control the release of the retrieval bag 20 from the support arms and actuator. While in the first deployment position, the retaining latch engages with the bead 50 to prevent the release of the retrieval bag 20 from the support arms and is releasably attached to the bead 50. When engaged with the bead 50, the retaining latch allows the retrieval bag 20 to be fully retracted into the introducer 3 by pulling the actuator 7 back to its proximal position for subsequent insertion through the trocar (Figure 2). When engaged with the bead 50, the retaining latch partially retracts the recovery bag 20 into the introducer tube to a redeployable tightening configuration (Figure 4), enabling reversible closure of the recovery bag opening. That is, multiple small tissue specimens can be contained in a single procedure by repeatedly performing the steps of advancing the actuator to a first deployment position (Figure 3) and retracting the actuator to a proximal position (Figure 4) to position the tissue recovery bag in a redeployable tightening configuration, using the continuous, repeated opening and closing of the tissue recovery bag 20 to allow subsequent withdrawal from the patient.

[0021] Referring to Figure 4, with a small tissue sample placed in the retrieval bag, the actuator 7 is retracted into the introducer 3 tube until the support arm 40 and cuff are retracted into the introducer 3 tube, providing partial retraction and closure of the retrieval bag 20 by leaving the distal portion of the retrieval bag 20 with the trapped tissue outside the introducer 3 tube. In this case, the tissue sample can be retrieved from the surgical site across the body wall using various techniques. For example, the tissue retrieval system 10 can be retracted through the trocar while the trocar remains positioned to traverse the body wall, or it can be retracted directly through the body wall after the trocar has been retracted from the patient. For very small tissue samples, the entire retrieval bag 20 with the trapped sample can be retracted into the introducer tube. In this case, the tissue retrieval system can be retracted through the trocar while the trocar remains positioned to traverse the body wall.

[0022] With the tissue retrieval system 10 withdrawn from the surgical site, the actuator 7 can be advanced distally to a first deployment position (Figure 1A) to retrieve a tissue sample for analysis. If it is desirable to obtain another smaller tissue sample, the actuator 7 can be withdrawn to a proximal position (Figure 2) for reintroduction into the surgical site, as described above. In certain embodiments, as will be described in detail below with reference to Figures 16-28 and 56-58, the tissue retrieval system may include a stop mechanism that limits the advancement of the actuator between the proximal position and the first deployment position until it is desirable to separate the tissue retrieval bag 20 from the actuator 7. Advantageously, these stop mechanisms can reduce the possibility of unintentional complete deployment of the tissue retrieval bag before all desired tissue samples have been collected for analysis.

[0023] The tissue retrieval system 10 can be used in procedures for extracting relatively large tissue specimens such as the gallbladder, appendix, or kidney. In these procedures, preferably with the tissue retrieval bag in the first deployment configuration (Figure 3) during insertion of a large tissue specimen such as the gallbladder, the retaining latch prevents inadvertent movement of the retrieval bag relative to the support arm and actuator. With the large specimen positioned in the tissue retrieval bag, it is desirable to tighten the retrieval bag and completely detach it from the introducer, leaving it in the body cavity. If the procedure requires the sequential extraction of small tissue specimens such as lymph nodes, and also requires the extraction of a larger tissue specimen, the tightening and detachment of the retrieval bag will be completed after the sequential extraction of the smaller tissue specimens. With the retrieval bag tightened, closed, and detached from the introducer, the surgeon can then remove the trocar from the body wall and then extract the retrieval bag through the body wall.

[0024] In certain embodiments, the tissue retrieval system 10 can be selectively operated from a first deployed configuration (Figure 3) to a fully deployed configuration (Figure 5) in which the actuator and tissue retrieval bag are located. When the surgeon determines that it is desirable to separate the tissue retrieval bag from the introducer, such as when a large or final tissue sample is placed inside the retrieval bag, the surgeon activates the release mechanism, for example, by pressing a release button on the handle assembly. Activation of the release mechanism allows the actuator to be advanced distally beyond the first deployed position to a second or fully deployed position (Figure 5). This advancement of the actuator to the fully deployed position positions the distal ends of the bead and retaining latch outside the distal end of the introducer tube.

[0025] Referring to Figures 5 and 6A, in certain embodiments, the tissue recovery system 10 may include a stop mechanism to prevent the bead from being reintroduced into the distal end of the introducer 3 after the actuator 7 has finished advancing to the fully deployed position. For example, in the illustrated embodiment, the tissue recovery system 10 includes a bead stop 60 positioned between the actuator 7 and the bead 50. As will be discussed in detail below with reference to Figures 10 to 15, when the actuator is in the fully deployed position, the bead stop also advances to its most distal position, where it locks into the introducer to occlude the distal end of the introducer 3. This occlusion prevents the bead and recovery bag from being pulled back into the introducer tube when fully deployed. This occlusion provides a support surface such that subsequent proximal pullback of the actuator from the fully deployed position pulls the support arms back from the cuff of the tissue recovery bag 20, tightening the tissue recovery bag 20 (Figure 6A). With the retrieval bag tightened and closed, the small loop 42 of the cord loop is exposed near the proximal end of the introducer 3 tube.

[0026] In certain embodiments, the tissue recovery system includes a cord loop positioned to selectively tighten the opening of the tissue recovery bag into a closed configuration. The cord loop extends through a cuff at the open end of the tissue recovery bag 20 and can extend proximal to the introducer along a receiving channel in the actuator. The cord loop can be releasably coupled to the actuator. In certain embodiments, the cord loop is dimensioned such that its proximal end is positioned between the proximal and distal ends of the actuator and held by the actuator. Preferably, in certain embodiments, the cord loop is dimensioned such that its length allows for tightening of the recovery bag and exposure of the cord loop on the actuator after tightening. The cord loop is maximally stretched when the recovery bag is tightened and closed. During tightening of the recovery bag prior to maximum tension of the cord loop, the cord loop is completely confined within the introducer tube of the recovery system. In certain embodiments, the cord loop is not exposed during the deployment of the recovery bag or during the retraction of the recovery bag into the introducer tube. For example, the cord loop is not exposed during insertion into the surgical site and retrieval of multiple small tissue samples (Figures 2-4). In these embodiments, the cord loop 42 is only exposed to the surgeon when it is maximally stretched and the retrieval bag is tightened and closed (Figure 6A). This feature prevents the surgeon from unintentionally grasping, cutting, releasing, or pulling the cord loop during use of the device. The cord loop can be stored in a non-stretched state within the introducer tube by folding and storing a portion of it within a receiving channel located on the underside of the actuator.

[0027] The cord loop 42 can provide an ergonomic and high-strength means for grasping the retrieval bag and pulling it back through the abdominal wall. Since the cord is formed from a single loop of cord, there are no constraints regarding the ability to grasp the cord loop by hand. Furthermore, the cord loop provides a strong means for pulling the retrieval bag back through the body wall by having its two strands absorb the tension applied by the surgeon. For example, if the surgeon applies a 20-pound tensile force to the cord loop while pulling the retrieval bag back, each strand of cord will be pulled with a force of 10 pounds. Certain other retrieval systems include relatively small loops of material, which can make it difficult to grasp the loop by hand. Similarly, other retrieval systems include small loops connected to a single cord strand or line, in which case a 20-pound tensile force is applied to the cord as a result of the 20-pound tensile force applied by the surgeon. In some cases, a single cord strand or line in these other retrieval systems may not function properly during the retrieval of the retrieval bag.

[0028] Another advantage provided by the cord loop is that the cord loop is relatively short after the retrieval bag is tightened, allowing for easier handling of the cord and easier retraction of the retrieval bag through the body wall. In certain embodiments of the tissue retrieval systems described herein, the length of the cord loop when the retrieval bag is tightened is approximately 14''. Other retrieval systems have a cord that is longer than approximately 25'' after the retrieval bag is tightened, thereby making the cord difficult to handle, manage, and use when retracting the retrieval bag through the body wall.

[0029] Referring to Figures 6A to 6C, there are at least two techniques for retracting the tightened tissue retrieval bag from within the body cavity once the tissue retrieval bag 20 is tightened. In the first method, the retrieval bag can be completely detached from the actuator and introducer tube by lifting the cord loop 42 from the holding slot on the actuator. Figure 6B is a detail view of the cord loop coupled to the actuator after the tissue retrieval bag has been tightened. In Figure 6B, the cord loop 42 comprises a single continuous loop. Figure 6C shows a detail view of another embodiment 43 of the cord loop that can be used in various embodiments of the tissue retrieval system described herein. In the illustrated embodiment, the cord loop 43 may be provided with a gripping loop 45 at the proximal end of the cord loop adjacent to the holding slot on the actuator. Advantageously, the gripping loop 45 can facilitate gripping the cord loop 43 after the tissue retrieval bag has been tightened. In certain embodiments, the gripping loop 45 can be coupled to the cord loop 43 by a thin interface, such as ultrasonic welding, bonding, heat welding, or melting. Such a thin interface allows the code loop to be routed through one or more sealing O-rings or other constrictions that may obstruct the passage of knots or other larger couplings, thus making the assembly of the code loop and actuator in the tissue recovery system desirable and easy.

[0030] Referring to Figure 6A, with the cord loop detached from the actuator, the device, trocar seal, and cannula can then be withdrawn from the body wall, leaving the retrieval bag 20 in the body cavity and the cord loop 42 positioned to traverse the body wall. Next, the neck of the retrieval bag can be withdrawn through the body wall, using the bead as an expander to assist in the movement of the retrieval bag through the tissue fiber layer in the body wall. With the neck of the retrieval bag traversing the body wall, the retrieval bag can then be reopened by grasping the closed end and bead of the retrieval bag by hand and sliding the bead along the cord. Next, the retrieval bag can be accessed and the contents of the retrieval bag can be removed or packed using standard laparoscopic instruments such as forceps, grasping forceps, and suction probes to assist in its complete withdrawal from the body cavity. With most of the contents removed, the retrieval bag can then be closed by grasping the open end and bead of the retrieval bag by hand and sliding the bead along the cord. Furthermore, the cord loop can be grasped by hand, and then the retrieval bag can be fully withdrawn from the body cavity. In some procedures, the surgeon can withdraw the retrieval bag through the body wall without re-opening it.

[0031] For smaller tissue specimens, such as a small gallbladder, that are likely to not need to be aspirated, packed, or removed from the retrieval bag before being withdrawn through the body wall, a second method for withdrawing the retrieval bag 20 from the body cavity can be used. In this case, the code loop can be left attached to the actuator, and the entire device, along with the trocar seal and cannula, can be withdrawn simultaneously from the body cavity through the body wall.

[0032] Referring to Figures 7 to 9, certain components of these systems that contribute to the redeployable operation of the tissue recovery system described herein are illustrated. In embodiments of the tissue recovery system, the operation of these components at the distal end of the introducer in a first deployed position is illustrated in Figures 10 and 11, and the operation in a second deployed position is illustrated in Figures 12 to 15. Figure 7 shows an embodiment of a bead for use with various embodiments of the tissue recovery system. Figure 8 shows an embodiment of a retaining latch for use with various embodiments of the tissue recovery system. Figure 9 shows an embodiment of a bead stop for use with various embodiments of the tissue recovery system.

[0033] Referring to Figure 7, an embodiment 50 of a bead for a tissue recovery system is illustrated. As shown, the bead 50 comprises a pair of channels 52 through which a support arm can slide. The bead 50 may further comprise a hole 54 that frictionally engages with a cord loop extending through it, to allow the recovery bag to be tightened and closed and reopened as needed after the recovery bag has been completely detached from the actuator and introducer. The bead may be configured to releasably engage with a retaining latch. In the illustrated embodiment, the bead 50 includes a recess 56 for engaging with the distal end of the retaining latch and a ledge 57 positioned therein. In certain embodiments, the bead 50 is injection molded from polycarbonate, and in other embodiments, it may be formed from other materials such as nylon, ABS, and polyester.

[0034] Continuing with the reference to Figure 7, in certain embodiments, the bead 54 is configured to facilitate the retraction of the constricted retrieval bag through the body wall. In certain embodiments, the proximal end of the bead 54 may have a blunt, tapered, or rounded face 58 to facilitate the retraction of the bead through the body wall. Thus, the bead can expand the muscle and tissue fibers of the body wall during the retraction of the retrieval bag. Advantageously, as the bead traverses the body wall, the constricted cuff and the remainder of the retrieval bag can easily follow it. A retrieval system without a bead may require the protruding cuff of the constricted retrieval bag to be retracted directly into the body wall, in which case the pleated cuff may sometimes catch on the body wall during the retraction of the retrieval bag, resulting in increased extraction force.

[0035] Continuing with the reference to Figure 7, an exemplary embodiment of the bead 50 includes a passage, bore, or hole 54 that frictionally engages with a cord loop extending through it, allowing the recovery bag to be tightened and closed and reopened as needed after the recovery bag has been detached from the introducer. Thus, during the retraction of the recovery bag from the body cavity, once the neck of the recovery bag has finished traversing the body wall, the recovery bag can be advantageously and easily reopened to allow access for removing or packing the contents of the recovery bag. Conventional recovery bags without a bead may be difficult or impossible to reopen once tightened and closed.

[0036] Continuing with the reference to Figure 7, in certain embodiments, the bead 50 may comprise a two-piece assembly comprising a bead body 51 and an annular clamp 53 positioned around a portion thereof (Figure 11). To bond a tissue recovery bag to the bead 50, a portion of the tissue recovery bag can be positioned between the bead body 51 and the clamp 53. Various bonding techniques, such as bonding with chemical adhesives, ultrasonic welding, heat welding, or other chemical, thermal, or mechanical bonding processes, can further secure the recovery bag to the bead body and / or clamp. In other embodiments, the bead may be a single component without surrounding clamps, and the single component bead can be bonded to the recovery bag using various chemical, thermal, or mechanical bonding processes.

[0037] Referring to Figure 8, an embodiment 70 of a retaining latch for use in various embodiments of a tissue recovery system is illustrated. The exemplary retaining latch 70 includes an actuator cap configured to be positioned at the distal end of an actuator. Thus, the retaining latch 70 may comprise a proximal portion 72 coupled to the distal end of the actuator. The retaining latch comprises a latch arm 74 extending distally from the proximal portion 72. The latch arm 74 may be configured to releasably engage with the bead. For example, in the illustrated embodiment, the latch arm 74 comprises a latch tab 76 at its distal end. In the illustrated embodiment, the latch tab 76 extends radially inward and releasably engages with the ledge 57 (Figure 7) of the bead 50. In certain embodiments, the actuator cap with an integral retaining latch is injection molded from polycarbonate, and in other embodiments, it may be formed from nylon, acrylonitrile butadiene styrene (ABS), polyester, polypropylene, stainless steel, spring steel, titanium, or nitinol.

[0038] In the illustrated embodiment, the actuator cap comprises only a single retaining latch that can engage with a corresponding ledge on the bead; however, in other embodiments, the actuator cap is envisioned to include two retaining latches that can engage with the bead, and the bead comprises two corresponding ledges. Furthermore, while the actuator cap and retaining latch are shown as a single component, in other embodiments, the actuator cap is formed of two components, in which case the body of the actuator cap is formed of a polymer material such as polycarbonate, ABS, nylon, or polypropylene, and the retaining latch is formed of a metallic material such as stainless steel, spring steel, titanium, or nitinol. In certain embodiments, the metal retaining latch is overmolded during the molding of the actuator cap, or bonded to the actuator cap, or heat-crimped to the actuator cap, or snapped onto the actuator cap, or mechanically captured between the actuator cap and the introducer tube, or mechanically captured between the actuator cap and the actuator. The metal retaining latch can be biased to spring to the release position when the actuator moves forward to the fully extended position. This separate retaining latch may include a spring or integrated spring element to bias it to a detached position from the ledge on the bead.

[0039] Referring to Figure 9, an example of a bead stop 60 for use in various embodiments of a tissue recovery system is illustrated. In the illustrated embodiment, the bead stop 60 comprises a body portion 62 and a locking arm 64. As shown, the locking arm 64 is integrally formed with the body portion 62 and is formed as a cantilever spring arm. The locking arm 64 may include a tab configured to engage with an introducer. The body portion 62 may be configured to be positioned between the distal end of the actuator of the tissue recovery system and the bead of the tissue recovery bag. Thus, the body portion 62 of the bead stop may include a channel 66 through which the latch arm 74 of the retaining latch 70 (Figure 8) passes, and one or more passages 68 through which a support arm coupled to the actuator and cord loop of the tissue recovery bag passes.

[0040] When the actuator is in the proximal deployment position or the first deployment position (Figures 2 and 1A), the cantilever spring arm of the bead stop is deflected within the introducer tube. When the recovery bag is advanced to the fully deployed position, the cantilever spring arm springs radially outward and engages and locks into the mating slot on the introducer tube. The actuator is designed to package and store the recovery system when the recovery bag is in the first deployment position. Therefore, when the actuator is in this position, the cantilever spring arm on the bead stop is subjected to a constant bending and deflecting force during device storage. For this reason, in certain embodiments, the bead is preferably formed from a high-thermal-grain polymer material with high creep resistance, such as polyetherimide (PEI), polyphenylsulfone (PPSU), or polyetheretherketone (PEEK). In other embodiments, the bead stop can be formed from stainless steel, spring steel, nitinol, or other metallic material. In certain embodiments, the bead stop can be formed from a combination of a polymer body made from polycarbonate, ABS, nylon, or polyester and a material such as a stainless steel spring arm. The stainless steel spring arm can be overmolded during the molding of the bead stop, bonded to the bead stop, heat-crimped to the bead stop, or snapped onto the bead stop.

[0041] An exemplary embodiment of the bead stop comprises a cantilever spring arm having a substantially rectangular prism tab configured to engage with a substantially rectangular slot in the introducer tube, but other embodiments envision the bead stop being able to have a substantially cylindrical projection on the cantilever spring arm that fits into a substantially circular opening in the introducer tube. Furthermore, this exemplary bead stop comprises a single cantilever spring arm, but other embodiments envision the bead stop comprising two or more cantilever spring arms capable of engaging with two or more corresponding slots or openings in the introducer tube.

[0042] Referring to Figures 10 and 11, the arrangement of the bead 50, bead stop 60, and retaining latch 70 at the distal end of the introducer 3 when the actuator 7 is advanced to a first deployment position (corresponding to the tissue retrieval system positioned as shown in Figure 3) is illustrated. The positions of the support arm 40 and code loop 42 when the actuator 7 is in the first deployment position are also illustrated. In the first deployment position, the latch arm 74 of the retaining latch 70 extends distally from the distal end of the actuator cap through the channel 66 of the bead stop 60. The latch tab 76 at the distal end of the latch arm 74 is positioned in a recess 56 on the bead 50, where it engages with the ledge 57 on the bead. The retaining latch 70 is in a non-flexible state when it is coupled to the bead 50. When actuator 7 is advanced to its first deployed position, the initial position of actuator 7 for redeployable use of the proximal portion of the bead 50, including the recovery bag, retaining latch 70, and recess 56 and ledge 57, is confined within the introducer 3 tube. While the retaining latch 70 and the proximal portion of the bead 50 are confined within the introducer 3 tube, the retaining latch 70 cannot detach from the bead 50 because there is insufficient clearance between the ledge 57 on the bead 50 and the inner diameter of the introducer tube for the retaining latch 70 to overcome the ledge 57 on the bead 50 and detach from the bead. Therefore, with actuator 7 in its first deployed position, the retaining latch 70 functions to allow the recovery bag to retract into the introducer tube when actuator 7 is pulled proximal.

[0043] Referring to Figures 12 and 13, the arrangement of the bead 50, bead stop 60, and retaining latch 70 at the distal end of the introducer 3 with the actuator 7 advanced to a second fully deployed position (corresponding to the tissue recovery system positioned as shown in Figure 5) is illustrated. The positions of the support arm 40 and cord loop 42 when the actuator is in the second deployed position are also illustrated. When the actuator is advanced to its fully deployed position, the bead 50 and the retaining latch 70 attached to it advance and exit from the distal end of the introducer 3 tube. Similarly, the bead stop 60 advances distally to a position where its locking arm 64 or integrated cantilever spring arm springs up and engages in the rectangular fitting slot 4 on the introducer 3 tube. When the bead stop 60 is engaged in the distal end of the introducer 3 tube, the bead stop 60 prevents the bead and recovery bag from being pulled back into the introducer tube.

[0044] Referring to Figures 14 and 15, the arrangement of the bead 50, bead stop 60, and retaining latch 70 at the distal end of the introducer 3 when the actuator 7 is being retracted from a second fully deployed position (corresponding to the tissue recovery system positioned as shown in Figure 5) is illustrated. The positions of the support arm 40 and cord loop 42 when the actuator is being retracted proximal from the second deployed position are also illustrated. In the illustrated embodiment, the retaining latch 70 includes an inclined contact surface at a latch tab 76 configured to detach from a ledge 57 on the bead 50 during the retraction of the actuator 7 and tightening of the recovery bag. When the actuator 7 is retracted and the recovery bag is tightened, the bead stop 60 prevents the bead 50 from being retracted into the introducer tube. In this stage, as the retaining latch 70 is retracted from the bead 50, the inclined contact surface on the retaining latch 70 engages with the ledge 57 on the bead 50, causing the retaining latch to flex and overcome the ledge 57, resulting in the detachment of the bead 50 from the retaining latch 70 (Figure 14). The distal end of the retaining latch 70 is positioned at a sufficient distance from the distal end of the introducer tube 3 so that the retaining latch 70 can flex and overcome the ledge 57 (Figure 14), and then return to the non-flexed position, allowing the retaining latch 70 to be easily retracted into the introducer tube 3 for subsequent tightening of the recovery bag (Figure 15). The proximal portion of the code loop is coupled to the actuator 7, and by continuing to pull back the actuator 7, the bead 50 presses against the main body of the bead stop 60, thereby tightening the opening of the tissue recovery bag (Figure 6). With actuator 7 pulled back to its proximal position, the support arm is pulled back from the cuff and bead 50 on the recovery bag, and at this time tension is applied to the cord loop, tightening and closing the bag.

[0045] In certain embodiments of the tissue recovery system in its initial shipment and insertion configuration, it may be desirable that the actuator be able to slide longitudinally only between a proximal position (Figure 2) and a first deployed position (Figure 1A) within the introducer. In this proximal position, the cord loop can be positioned within the introducer in an inaccessible manner. In the first deployed position, the tissue recovery bag is coupled to the introducer. By restricting the movement of the actuator to these positions, the possibility of the tissue recovery bag being unintentionally detached from the introducer is reduced. That is, in certain embodiments, the tissue recovery system includes a proximal stop mechanism and a distal stop mechanism. It may be desirable that these stop mechanisms be selectively released so that the actuator of the tissue recovery system can be advanced distally beyond the first deployed position to a fully deployed position, and then pulled back beyond the proximal position after fully deployed to expose the cord loop. Furthermore, with the cord loop exposed, it may be desirable to prevent complete retraction of the actuator from the introducer tube, which could provide a leakage route into the surgical site during air supply, and to prevent the actuator from redeploying, which could unnecessarily advance the support arm into the surgical site. Accordingly, in addition to the releaseable proximal and distal stop mechanisms described above, in certain embodiments, the tissue retrieval system may include either or both an actuator retraction stop mechanism and an actuator redeployment lockout mechanism to tighten the tissue retrieval bag and restrict the movement of one or both actuators in the proximal and distal directions following access to the cord loop.

[0046] The proximal stop mechanism can prevent the actuator and retrieval bag from retracting too deeply into the introducer during the retraction of the retrieval bag into the introducer. Before each insertion into the trocar during the procedure, the retrieval bag is fully retracted into the introducer by pulling the actuator proximal to its proximal position. During this retraction, the proximal stop mechanism prevents the actuator and retrieval bag from retracting too deeply into the introducer and sometimes being completely pulled out of the introducer. In certain embodiments, the proximal stop mechanism further prevents the cord loop from being exposed during the retraction of the retrieval bag into the introducer. In retrieval systems that do not have a feature to control the proximal movement of the actuator, the actuator and retrieval bag may sometimes be pulled into the device handle, resulting in the retrieval bag becoming stuck in the handle and unable to move. In these systems without a proximal stop mechanism, during yet another proximal movement, the actuator and retrieval bag may be completely pulled out of the introducer through the device handle, potentially rendering the device unusable for the surgeon.

[0047] Referring to Figures 16–19, an embodiment of a proximal stop mechanism for a tissue recovery system is illustrated. The handle may include an axially movable actuator post 80 positioned perpendicular to the longitudinal axis of the actuator 7, allowing the recovery bag to be retracted into the introducer 3 while preventing the cord loop on the actuator from being exposed. The actuator post 80 may comprise a substantially cylindrical body having a first end and a second end opposite to it. The actuator post may have one or more cantilever snap legs 82 projecting radially outward from the second end. The actuator post 80 is positioned within a bore 92 formed within the handle assembly. As shown, the bore 92 is formed in the lower handle portion 90 of the handle assembly. The cantilever snap legs 82 rest on an inclined surface 94 within the bore 92 of the lower handle and function to maintain the actuator post 80 in a stop position or a protruding position. The lower surface of the actuator 7 is sized and dimensioned to allow it to freely pass over the actuator post 80 when the actuator slides longitudinally between the proximal position and the first deployed position. The lower surface of the actuator 7 may further include a ledge 96 formed therein and positioned to engage with the actuator post 80 to prevent the actuator from moving past the proximal position. In this actuator position, the cord loop remains confined within the handle and introducer tube (Figure 2). Thus, when positioned in the protruding position, the actuator post 80 allows the retrieval bag to be fully retracted into the introducer tube without exposing the cord loop and to be deployed multiple times from the introducer tube.

[0048] In certain embodiments, the actuator post is biased to a protruding or blocked position. For example, the proximal stop mechanism may further include a compression spring for biasing the actuator post to the protruding position to engage with a ledge on the actuator. The compression spring is positioned within the inner diameter of the actuator post and can press against the handle assembly.

[0049] Referring to Figures 20 to 22, an embodiment of the proximal stop mechanism is illustrated in which the actuator is advanced to a second fully deployed position. In various surgical procedures, it may be desirable to pass the proximal position and pull the actuator back to the proximal position after the tissue retrieval bag has been fully deployed and separated from the actuator. Therefore, when the actuator is pulled back to the proximal position, the support arm can be detached from the tissue retrieval bag cuff, and the cord loop can be made accessible so that the retrieval bag can be pulled back from the surgical site. In other words, it may be desirable that the proximal stop mechanism be deactivated after the actuator 7 has been operated to the fully deployed position.

[0050] Continuing with the reference to Figures 20-22, in certain embodiments, the actuator includes a cam bevel 98 formed within the actuator and positioned adjacent to its proximal end, such that when the actuator is advanced to its fully extended position, it pushes the actuator post 80 downward to a detachment position from the actuator. When the actuator 7 is advanced, the cam bevel 98 on the proximal end of the actuator contacts the actuator post 80 and exerts a downward cam action on this post to a non-protruding position where the cantilever snap leg 82 locks into the lower handle. With the actuator post 80 locked in the non-protruding position, the actuator 7 can be pulled back beyond the proximal position, and the cord can be maximally pulled to tighten the retrieval bag and expose the cord loop. Once the cord loop is exposed on the actuator 7 proximal to the handle, the surgeon can grasp the cord loop and release it from the actuator, leaving the cord loop positioned to traverse the body wall for subsequent retrieval of the retrieval bag from the patient, allowing the introducer and trocar to be removed from the patient's body wall.

[0051] In other words, advantageously, by using a proximal stop mechanism, the code loop of the tissue recovery system discussed herein is not exposed to the surgeon until the recovery bag is tightened and closed. This feature can prevent the surgeon or nurse from inadvertently grasping, cutting, releasing, or pulling the code loop during use of the device. Some procedures may require the surgeon to sequentially confine and retrieve 20 or 21 or more tissue specimens, requiring extensive handling and manipulation of the tissue recovery system by the surgeon and nurse both inside and outside the patient's body. The contained code loop of the present invention avoids the opportunity for the code loop to be grasped, cut, released, pulled, or tangled during the extensive handling and manipulation of the device that may occur during the procedure. In the absence of a proximal stop mechanism, other tissue recovery systems may have a code or line used to tighten a recovery bag that is always fully exposed to the surgeon during use of the device. In some of these devices, the code or line may be attached to the proximal end of an actuator or introducer handle, thereby allowing the surgeon or nurse to release the code or line prematurely during the procedure, resulting in an unintended release of the recovery bag from the introducer. The cuff of the retrieval bag may become partially tightened prematurely, potentially resulting in a reduction in the size of the retrieval bag opening and the possibility of the cuff being torn or punctured by the support arm. There is also a possibility that the cord or line may be cut during the procedure, become tangled within the device, or become entangled with other devices such as trocars.

[0052] By disabling the proximal stop mechanism, the actuator can be allowed to retract proximally beyond its proximal position. However, in certain embodiments, the handle assembly may further include an actuator retraction stop configured to prevent the actuator from being fully retracted proximally from the introducer tube. In certain embodiments, the handle assembly includes a rib that mates with a slot on the actuator. The slot in the actuator has an end wall positioned to define a proximal limit of the actuator's advance to prevent the actuator from being fully retracted from the introducer during tightening of the recovery bag for subsequent detachment of the recovery bag from the introducer. The combination of the rib and slot allows for the exposure of the cord loop during tightening of the recovery bag and prevents any further retraction of the actuator. Advantageously, this actuator retraction stop ensures that carbon dioxide used to establish and maintain pneumoperitoneum in the body cavity during the surgical procedure does not leak through the introducer. In certain embodiments, the tissue recovery system includes an O-ring seal positioned on the actuator between its proximal and distal ends to maintain a seal with the inner surface of the introducer tube. Certain other retrieval systems may require the entire actuator to be retracted from the introducer before the retrieval bag is tightened. Generally, this retraction is performed with the introducer inserted into the surgical site through the trocar. With these devices, when the actuator is fully retracted from the introducer, a significant leakage pathway may be created through the introducer, causing the retrieval bag to dangle from the distal end of the introducer within the body cavity, resulting in pneumoperitoneum loss.

[0053] In certain embodiments of tissue retrieval systems, an O-ring positioned between the proximal and distal ends on the actuator also provides an effective seal when the retrieval bag is deployed into a body cavity while air is being supplied. The O-ring provides a seal between the actuator and the introducer tube that prevents loss of pneumoperitoneum while the surgeon is excising the tissue specimen and placing it into the retrieval bag. Certain other retrieval systems include a seal in the handle positioned proximal to the introducer tube that attempts to provide a seal to the actuator. These seals are generally not effective in preventing loss of pneumoperitoneum because there can be many leakage routes between the introducer tube and the handle, between the actuator and the introducer tube, between the upper and lower handle halves, between the handle and the introducer tube, between the seal and the actuator, and between the seal and the cord or tail of the retrieval bag.

[0054] Referencing Figures 23A, 24A, 25A, 26A, 27A, and 28A, embodiments of distal stop mechanisms are illustrated. In certain embodiments, the tissue retrieval system includes a distal stop mechanism to prevent the actuator from moving distal to a first deployment position (Figure 1A) in which the tissue retrieval bag remains attached to the actuator. Preferably, such a stop allows for repeated deployment of the tissue retrieval bag for the sequential retrieval of multiple tissue samples. In certain embodiments, it is desirable that the distal stop mechanism be selectively released or deactivated so that a surgeon can control the distal advance of the actuator to a fully deployed position in which the tissue retrieval bag can be separated from the actuator.

[0055] Referring to Figures 23A, 24A, 25A, and 26A, the distal stop mechanism may include a selectively releaseable deployment latch. In certain embodiments, the deployment latch may include a release button 110 positioned in the handle assembly. As shown, the release button 110 is incorporated into the upper handle. As shown, the button 110 includes a wall 112 extending along each side of the actuator 7. The wall 112 includes a latch tab or stop tab 114 extending radially inward and a recess 116 positioned radially outward. The release button 110 includes two posts 118 extending from the lower surface of the wall 112. Each of the posts 118 may be positioned in a corresponding bore in the handle assembly and can hold a compression spring 120 so that the post 118 and the compression spring 120 are incorporated into the lower handle. The compression spring 120 biases the button 110 upward when the handle assembly is oriented as shown in Figure 26A. In the illustrated embodiment, the button 110 has a substantially triangular shape aligned to inform the user of the direction of travel of the actuator 7. In other embodiments, the release button may have a square, circular, elliptical, or other shape. In certain embodiments, an icon or stylized logo may be added to the button to convey information to the user.

[0056] Continuing with the references to Figures 23A, 24A, 25A, and 26A, the actuator 7 may include a radially projecting rib 130 adjacent to its proximal end. In certain embodiments, the actuator may include a separately molded thumb loop 132 that can be pressed onto the actuator 7 by interference pins and holes. The thumb loop 132 may include a rib 130 molded along its longitudinal axis.

[0057] Referring to Figures 25A and 26A, an example of the tissue retrieval system handle assembly is shown when the actuator is in a first deployed position and the distal stop mechanism is engaged so that the deployment latch is in a latch configuration. The release button 110 is biased upward so that the stop tab 114 on the wall 112 prevents distal movement of the rib 130 of the actuator 7. When the actuator 7 is initially advanced to deploy the retrieval bag, the rib on the thumb loop contacts the wall on the button to prevent the actuator from advancing beyond its initial position. Thus, when the release button 110 is not pressed, the button 110 only allows the actuator 7 to advance to the first deployed position, and the retrieval bag is deployed from the distal end of the introducer but coupled to the actuator, in which case the retrieval bag can be subsequently retracted into the introducer (Figure 1A).

[0058] Referring to Figures 27A and 28A, the handle assembly of the tissue retrieval system is illustrated when the actuator is in the second fully deployed position and the distal stop mechanism is released. When it is desirable to release the tissue retrieval bag from the actuator during the procedure, the surgeon can press the release button 110 on the handle assembly. When the button 110 is pressed downward, the wall 112 on the button moves to position the stop tab 114 so as to disengage from alignment with the rib 130 on the actuator 7, and then allows the actuator to be advanced to its fully deployed position. When the actuator 7 is advanced, the rib 130 can slide within the recess 116 of the wall 112. A compression spring 120 biases the button 110 upward and functions to return the button to the raised position (Figures 25A, 26A) after it has been pressed and then released. Therefore, when button 110 is pressed downward to disable the distal stop mechanism, the actuator can then advance to its fully extended position, and in this position the recovery bag can be tightened and closed and detached from the introducer. In certain embodiments, the step of advancing the actuator to the fully extended position also disables a proximal stop mechanism, such as the actuator post described and illustrated with reference to Figures 16 to 22. The cord loop can then be pulled and the recovery bag tightened, allowing the actuator to be fully retracted to expose the small cord loop on the actuator.

[0059] Referring to Figures 23B, 24B, 25B, 26B, 27B, and 28B, another embodiment of the distal stop mechanism is illustrated. Similar to the embodiments discussed above with reference to Figures 23A, 24A, 25A, and 26A, the distal stop mechanism may include a selectively releaseable deployment latch. In certain embodiments, the deployment latch may include a release button 111 positioned on the handle assembly. As shown, the release button 111 is nested within the upper handle. As shown, the button 111 includes a wall 113 extending along each side of the actuator 7. The wall 113 includes a latch tab or stop tab 115 extending radially inward and a recess 117 positioned radially outward. The release button 111 includes two posts 119 extending from the lower surface of the wall 113. Each of the posts 119 can be positioned in a corresponding bore within the handle assembly, and a compression spring 120 can be held so that the posts 119 and the compression spring 120 are nested within the lower handle. The compression spring 120 biases the button 111 upward when the handle assembly is oriented as shown in Figure 26B. In the illustrated embodiment, the button 111 has a substantially triangular shape aligned to communicate the direction of travel of the actuator 7 to the user. In other embodiments, the release button may have a square, circular, elliptical, or other shape. In certain embodiments, an icon or stylized logo may be added to the button to communicate information to the user.

[0060] Continuing with reference to Figures 23B, 24B, 25B, and 26B, the actuator 7 may include at least one longitudinally extending rail, slot, or groove 131 such that the stop tab 115 of the button 111 is in a sliding engagement state. The button 111 is biased such that the stop tab 115 is adjacent to the upper edge of the groove 131. In certain embodiments, the button may be sized and configured so that the stop tab 115 is adjacent to the upper edge of the groove 131 but does not contact it, in order to prevent frictional contact between the stop tab 115 and the groove 131 when the actuator 7 is slid. As shown, the groove 131 includes a proximal end wall 133 adjacent to its proximal end. The groove 131 further includes an unfolding segment 135 proximal to the proximal end wall 133. The unfolding segment can extend along an axis that is parallel to the longitudinal axis of the portion of the groove 131 distal to the proximal end wall 133 and offset therefrom by the height of the proximal end wall 133.

[0061] Referring to Figures 25B and 26B, an example of a tissue recovery system handle assembly is shown in which the actuator is in a first deployed position and the distal stop mechanism is engaged such that the deployment latch is in a latch configuration. The release button 111 is biased upward so that the stop tab 115 of the wall 113 interferes with the proximal end wall 133 of the groove 131, preventing further distal movement of the actuator 7. Thus, when the release button 111 is not pressed, the button 111 only allows the actuator 7 to advance to the first deployed position, and the recovery bag is deployed from the distal end of the introducer but coupled to the actuator, in which case the recovery bag can be subsequently retracted into the introducer (Figure 1A).

[0062] Referring to Figures 27B and 28B, an example of a tissue retrieval system handle assembly is shown with the actuator in a second fully deployed position and the distal stop mechanism released. When it is desirable to release the tissue retrieval bag from the actuator during the procedure, the surgeon can press the release button 111 on the handle assembly. When the button 111 is pressed downward, the wall 113 on the button moves to position the stop tab 115 away from alignment with the proximal end wall 133 of the groove 131 on the actuator 7 and into alignment with the deployment segment 135 of the groove, thereby allowing the actuator to be advanced to its fully deployed position. When the actuator 7 is advanced, the stop tab 115 can slide within the deployment segment 135 of the groove 131. A compression spring 120 biases the button 111 upward and functions to return the button 111 to the raised position (Figures 25B and 26B) after it has been pressed and then released. Therefore, when button 111 is pressed downward to disable the distal stop mechanism, the actuator can then be advanced to its fully extended position, and in this position the recovery bag can be tightened and closed and detached from the introducer. In certain embodiments, the step of advancing the actuator to the fully extended position also disables the proximal stop mechanism, such as the actuator post described and illustrated with reference to Figures 16 to 22. The cord loop can then be pulled and the recovery bag tightened, allowing the actuator to be fully retracted to expose the small cord loop on the actuator.

[0063] Referring to Figures 27C and 28C, an example of a tissue retrieval system handle assembly is shown in which the actuator is retracted proximal to a position corresponding to the tightened tissue retrieval bag following the full deployment of the tissue retrieval bag (Figure 6A). In some embodiments, the distal stop mechanism in Figures 23B, 24B, 25B, 26B, 27B, and 28B further comprises a redeployment latch mechanism. As shown, when the tissue retrieval bag is in the tightened configuration (Figure 6A), the groove 131 of the actuator extends distally along the actuator 7 in a longitudinal direction to a position corresponding to the proximal retracted position of the actuator 7. The groove 131 comprises a redeployment latch inclined surface 137 formed within its upper edge and longitudinally positioned adjacent to this proximal retracted position on the actuator 7, a radial latch end wall 139, and a redeployment latch segment 141. Therefore, when the actuator is retracted relative to the handle assembly to tighten the tissue retrieval bag, as shown in Figure 28C, the stop tab 115 of the button 111 is biased to engage with the redeployment latch inclined surface 137 adjacent to the upper edge of the redeployment latch segment 141, beyond the radial latch end wall 139. Attempts to advance the actuator 7 distally from this proximal retracted position are thought to engage the stop tab 115 with the radial latch end wall 139, thereby suppressing further distal movement of the actuator 7. Thus, the redeployment latch mechanism can desirablely prevent unintentional redeployment of the support arm when the tissue retrieval system is activated to fully tighten the tissue retrieval bag.

[0064] Referring to Figures 29-30, in certain embodiments, the tissue recovery system may include a bead stop 160 having a snap ring 162, such as a stainless steel snap ring, instead of the bead stop 60 described and illustrated with respect to Figure 9. Other embodiments of the tissue recovery system described above can be used in combination with the bead stop 160. The slot 30 in the introducer tube can be sized and configured to receive the snap ring 162 and lock into engagement with the bead stop 160. The snap ring is thought to remain compressed within the introducer tube when the actuator is in its first deployed position for redeployable use of the recovery bag. When the actuator 7 is advanced to its fully deployed position (Figures 29-30) to allow tightening of the recovery bag, the snap ring expands and enters the slot 162 on the introducer tube, preventing the bead 50 and the recovery bag from retracting into the introducer tube. The snap ring 162 may have a gap 164 formed therein and aligned with a corresponding gap in the bead stop 160, and the retaining latch 70 may extend through the gap 164.

[0065] Referring to Figures 31A and 32A, in certain embodiments, the tissue recovery system may include a bead stop 260 having a spring-driven clip 262 instead of the bead stop 60 described and illustrated with respect to Figure 9. Other embodiments of the tissue recovery system described above can be used in combination with the bead stop 260. The introducer tube may include an opening sized and configured to receive the clip 262 and lock into engagement with the bead stop when the actuator is moved to the fully extended position. The bead stop 260 may further include a compression spring 264 positioned between the clip 262 and the bead stop body. The clip 262 remains compressed when the actuator is between the proximal position and the first extended position for redeployable use of the recovery bag. When the actuator is advanced to its fully extended position to allow tightening of the recovery bag, the clip 262 is driven upward by the compression spring 264 to engage with the opening in the introducer tube, preventing the bead and recovery bag from retracting into the introducer tube. The bead stop 260 may include a channel 266 through which a retaining latch for a tissue retrieval system can extend. The bead stop 260 may further include a pair of axially spaced slots 268 and a passage sized and configured to receive a support arm and a code loop for a tissue retrieval system through it.

[0066] Referring to Figures 31B and 32B, in certain embodiments, the tissue retrieval system may include another embodiment 261 of a bead stop having a spring-biased clip 263 similar to the bead stop 260 of Figures 31A and 32A. The bead stop 261 may further comprise a compression spring 265 positioned between the clip 263 and the bead stop body. The bead stop 261 may comprise a channel 267 through which the retaining latch of the tissue retrieval system can extend. Unlike the bead stop 260 of Figures 31A and 32A, the channel 267 of the bead stop 261 may be formed seamlessly to have a central recess 269 sized and configured to receive the support arm and the cord loop of the tissue retrieval system through it. Preferably, the channel 267 and the seamlessly formed central recess 269 enhance the ease and speed of assembling the bead stop 261 with the support arm and cord loop during the assembly of the tissue retrieval system.

[0067] Referring to Figures 33 to 35, in certain embodiments, the redeployable tissue recovery system may include an actuator cap with a rotatable retaining latch. As shown, the actuator cap 170 includes a distal extension 172 with a fork, on which a rotatable latch 174 is positioned above a pin 176 in the fork. The rotatable latch 174 can rotate around the pin 176 and is releasably coupled to a ledge 57 on the bead 50 to hold the bead 50 and the recovery bag against the actuator 7. When the actuator 7 is between the proximal position and the first deployment position for redeployable use of the recovery bag (Figure 34), the rotatable latch 174 engages with the ledge 57 on the bead 50 and is prevented from rotating by the introducer 3 tube. When the actuator is advanced to its fully deployed position to allow tightening of the recovery bag (Figure 35), the rotatable latch 174 is positioned outside the introducer 3 tube and rotates freely. When the actuator 7 is retracted to tighten the recovery bag, the rotary latch 174 rotates to a position where it is detached from the bead 50. In certain embodiments of the tissue recovery system, an actuator cap 170 with the rotary latch 174 can be used without a bead stop (Figures 34-35). In the absence of a bead stop, the material in the recovery bag near the bead 50 can clump together outside the introducer 3 tube, allowing for tightening. In other embodiments, the actuator cap 170 with the rotary latch 174 can be used in combination with a bead stop. In these embodiments, a forked extension on the actuator cap 170 extends through a channel in the bead stop.

[0068] Referring to Figures 36-38, in certain embodiments, the tissue recovery system may include a bead 150 on which a radially expandable element, such as a snap ring 152, is positioned. The snap ring 152 can be positioned around the proximal portion of the bead 150. The proximal portion of the bead 150 with the snap ring 152 remains within the introducer 3 tube when the actuator is slidable between the proximal position and the first deployed position for redeployable use of the recovery bag. During redeployable use of the recovery bag, the snap ring 152 remains compressed within the introducer 3 tube and has a first outer diameter determined by the inner diameter of the introducer 3 tube. When the actuator is advanced to its fully deployed position (Figures 37-38), the snap ring 152 is thought to be positioned outside the introducer tube, where it expands to a second outer diameter greater than the inner diameter of the introducer tube, preventing the bead and recovery bag from retracting into the introducer 3 tube and enabling the recovery bag to be tightened. Therefore, these embodiments allow the tissue recovery system to prevent the bead from re-entering the introducer without using a bead stop. The snap ring 152 includes a gap 154 ​​for receiving the retaining latch 70. In the illustrated embodiment, the retaining latch 70 extends through the gap 154 ​​in the snap ring 152 such that its distal tip is positioned distal to the snap ring 152. When the actuator is advanced distally to the second deployed position, the snap ring 152 contacts the distal end of the introducer tube, so the distal tip of the retaining latch 70 is positioned outside the introducer tube and will be detached from the ledge 157 on the bead 150 when the actuator is retracted.

[0069] In other embodiments, including a guide bead 150 with a snap ring 152, the distal tip of the retaining latch 70 is positioned proximal to the snap ring so that the retaining latch remains positioned within the introducer tube when the actuator is in the fully extended position. When the actuator is advanced to its fully extended position, the snap ring is envisioned to expand to prevent the bead and recovery bag from retracting into the introducer tube. The distal tip of the retaining latch is envisioned to engage with a slot in the introducer tube that is large enough to allow the retaining latch to flex and detach from the ledge on the bead, and to allow the recovery bag to be tightened.

[0070] Referring to Figures 39 to 42, in certain embodiments, the tissue recovery system may include a bead 250 with an O-ring 252, which is thought to function to prevent the bead 250 and the recovery bag from retracting into the introducer tube in order to allow the recovery bag to be tightened. That is, in these embodiments, the tissue recovery system can prevent the bead from re-entering the introducer without using a bead stop. In the illustrated embodiments, the O-ring 252 is positioned around the proximal portion of the bead 250. The proximal portion of the bead with the O-ring remains inside the introducer tube when the actuator is in its initial position and is slidable between the proximal position and the first deployed position for redeployable use of the recovery bag. During redeployable use of the recovery bag, the O-ring 252 is thought to remain compressed inside the introducer tube. When the actuator is advanced distally to its fully deployed position (Figures 39-40), the O-ring 252 is thought to be positioned outside the introducer tube, where it is thought to expand to a larger diameter, preventing the bead 250 and the recovery bag from retracting into the introducer tube and enabling the recovery bag to be tightened.

[0071] Continuing with the reference to Figures 39–42, in certain embodiments of the tissue recovery system, a guide bead 250 having an O-ring 252 is used with one or two retaining latches 270. In the illustrated embodiment, the retaining latch 270 releasably engages with the bead 250 proximal to the O-ring 252 and remains positioned within the introducer tube when the actuator is advanced to the fully extended position. The introducer tube 3 may have corresponding slots 30 sized and positioned to allow the retaining latch to flex radially outward (Figure 41) and detach from the ledge on the bead, and to allow tightening of the recovery bag (Figure 42). In various embodiments, the retaining latch comprises separate components mechanically captured, pivotably coupled to, or otherwise attached to the actuator cap. In certain embodiments, the retaining latch is biased radially outward. For example, in certain embodiments, the retaining latch includes an integral leaf spring for biasing it to the radially expanded position.

[0072] Referring to Figures 43 to 55, in certain embodiments, it is desirable that the bead be securely attached to the retrieval bag so that it remains attached during multiple deployment and tightening cycles of the retrieval bag in the surgical procedure. In yet other embodiments, certain aspects of the bead in Figures 43 to 55 can be combined with other aspects described with respect to the bead in Figures 36 to 42.

[0073] Referring to Figures 43 to 45, in certain embodiments, the bead 350 on the recovery bag consists of two halves 352, 354 pressed against each other or ultrasonically welded to each other by interference pins 356 and interference holes 358. In the illustrated embodiment, the lower bead half 352 further comprises a vertical post 360 sized and configured to fit through the proximal end of the recovery bag 20. The proximal end of the recovery bag 20 includes a belt 22 that is thermally melted to engage with the post 360 on the lower bead half 352 to securely bond the bead 350 to the recovery bag 20. A cord loop 42 can be routed outside the belt. The upper bead half 354 is positioned across the post to mechanically capture the belt 22 of the recovery bag 20 within the bead halves 352, 354. Each of the upper and lower halves 352, 254 may include a semicircular groove 362 along its longitudinal axis at its center, the groove 362 positioned at the proximal end of the bead 350 and configured to frictionally engage with the cord loop. When the bead halves are assembled together, the semicircular groove 362 forms a circular opening that generates frictional engagement with the cord, allowing the recovery bag to be tightened, closed, and reopened. The bead halves may include inclined guides 364 and fitting slots for the guides surrounding the semicircular grooves that help center the cord within these grooves during bead assembly. In the illustrated embodiment, the lower bead half 352 includes a recess 357 and a ledge 359 for engaging with a retaining latch.

[0074] Referring to Figures 46-48, in certain embodiments, the bead 450 on the recovery bag consists of two halves 452, 454 ultrasonically welded to each other to securely bond it to the recovery bag 20. In the illustrated embodiment, the right bead half 452 includes an elliptical post 456 sized and configured to fit into a corresponding elliptical hole 26 in the proximal end of the recovery bag 20. In certain embodiments, the proximal end of the recovery bag 20 includes a die-cut elliptical hole 26 that fits across the post in the right bead half. The cord loop 42 can be routed above or below the post. The left bead half 454 is positioned across the post 456 to mechanically capture the proximal end of the recovery bag 20, and these bead halves 452, 454 are joined by ultrasonic welding or the like. Each of the right and left bead halves 452, 454 also includes a semicircular groove 458. The semicircular groove 458 can be positioned at the proximal end of the bead 450. When the bead halves 452 and 454 are joined (Figure 47), the semicircular groove 458 can be sized to frictionally engage with the cord loop and collectively form a central passage through the bead 450. Each of the right and left bead halves 452 and 454 includes a recess 457 and a portion of a ledge 459 for engaging with a retaining latch.

[0075] Continuing with the references to Figures 46-48, the exemplary bead includes a single post positioned to hold the bag, while in other embodiments, the right bead half includes two or more posts, such as circular posts designed to engage with corresponding die-cut holes in the proximal end of the recovery bag. Furthermore, in certain embodiments, the proximal end of the recovery bag 20 having a die-cut elliptical hole includes a reinforcing material to increase the strength with which the recovery bag is held to the bead. In various embodiments, the reinforcing material can be ripstop nylon, polyurethane, nylon, or other suitable material.

[0076] Referring to Figures 49 to 51, in certain embodiments, the bead 550 on the recovery bag consists of a proximal section 552 and a distal section 554 pressed against each other by interference pins 556 and interference holes 558. In the illustrated embodiment, the bead also includes an annular interlocking fit for holding the recovery bag 20 against the bead 550 and for securing the proximal section 552 and distal section 554 of the bead 550 together. The distal section 554 of the bead also includes an annular ledge 557 designed to further hold the recovery bag against the bead. To assemble the bead 550, a cord loop 42 is first passed through each of the bead segments 552 and 554, and then the distal section 554 of the bead is inserted through the distal end of the tubular portion of the recovery bag. Next, the proximal section 552 of the bead is positioned across the bead and the distal section 554 of the recovery bag 20, and these two sections of the bead are pressed against each other to capture the tubular portion of the recovery bag. In certain embodiments, the distal section 554 of the bead may include a slot instead of a through hole to avoid the need to pass the cord loop through the distal section 554 of the bead. In certain embodiments, adhesive may be applied to the annular interlock and interference pin to further enhance the retention force of the recovery bag 20 on the bead 550. In the illustrated embodiment, the proximal section 552 of the bead includes a recess 560 and a ledge 562 for coupling with a retention latch.

[0077] Referring to Figures 52-55, the bead 650 on the recovery bag consists of two substantially identical halves 652 ultrasonically welded to each other. The bead halves 652 include energy inductors 654 for ultrasonically welding the bead halves to each other. The bead halves also include multiple energy inductors 656 for ultrasonically welding the outer proximal portion of the recovery bag between the bead halves 652. To assemble the recovery bag to the bead 650, the recovery bag is inserted between the bead halves 652, and then the bead halves are ultrasonically welded to the outside of each side of the recovery bag. The bead halves 650 can be ultrasonically welded to each other simultaneously or to each other as a secondary step. To ensure that the cord loop is not welded to the bead or recovery bag during assembly, the cord loop is positioned in a central recess during welding. The bead halves also include a semicircular groove 658 designed to frictionally engage with the cord loop at its center along the longitudinal axis of the bead halves at the proximal end of the bead. The bead half 652 includes a guide 660 that helps center the cord loop in the groove during bead assembly, and a mating slot for the opposing guide surrounding the semicircular groove 658. The bead half includes a recess and a ledge 662 for engaging with a retaining latch.

[0078] Referring to Figures 56 to 61, in certain embodiments, the handle assembly comprises a pawl assembly. The pawl assembly can be configured to provide both a secondary proximal stop mechanism and a redeployment lockout mechanism.

[0079] Referring to Figures 56-58, the claw assembly may comprise a claw 702 pivotally coupled to the handle assembly and a claw spring 704. The claw spring 704 is positioned around the claw 702 and biases the claw 702 to its central position. When the actuator is in its initial position and slidable between a proximal position and a first deployed position for redeployable use of the retrieval bag, the claw 702 is tilted relative to the distal end of the device. The actuator 7 comprises a longitudinally extended rib 710 in which a first recess 712 is formed. When the actuator is pulled back proximal from the first deployed position (Figure 56), the claw 702 slides along the rib 710. When the actuator 7 is pulled back to retract the retrieval bag into the introducer tube, the claw 702 falls into the first recess 712 on the actuator 7 and engages with the distal wall 714 of the recess 712, preventing any further proximal movement of the actuator. Preferably, the first recess 712 is positioned on the rib at a location where it engages with the claw at the actuator position corresponding to the proximal position of the actuator to ensure that the cord loop is not exposed. Thus, in certain embodiments, the handle assembly includes a secondary proximal stop mechanism to prevent the recovery bag from being pulled back excessively deep into the introducer to the extent that the cord loop would be exposed. In other embodiments, the claw assembly may provide a primary proximal stop mechanism, and the actuator post described with reference to Figures 16-22 is not present in the handle assembly.

[0080] Referring to Figures 59 to 61, when the actuator is advanced to its fully deployed position for subsequent tightening of the retrieval bag, the claw 702 moves away from the proximal end of the rib 710 and moves to its center position (Figure 59). When the actuator 7 is pulled back proximal to begin tightening of the retrieval bag, the claw 702 pivots toward the proximal end of the device by engaging with the proximal end of the rib 710. The rib 710 further comprises a second recess 716 located distal to the first recess 712. When the actuator 7 is fully pulled back with the retrieval bag tightened and closed, the code loop is exposed and the claw 702 falls into the second recess 716 on the rib 710 (Figure 60). The claw 702 engages with the proximal wall 718 of the second recess 716 to prevent the actuator 7 from advancing distally (Figure 61). This engagement between the claw 702 and the second recess 716 establishes a redeployment lockout mechanism to prevent the surgeon from inadvertently advancing the actuator after the recovery bag has been detached from the actuator and tightened. If the actuator is inadvertently redeployed, it may result in the undesirable consequence of the support arm advancing and disengaging from the distal end of the introducer. Similarly, the claw assembly holds the actuator in its fully retracted position and allows for easy removal of the cord loop from the actuator.

[0081] In other words, the illustrated embodiment of the claw assembly engages with a first recess and a second recess on the actuator rib to provide both a proximal stop mechanism and a redeployment lockout mechanism. However, in other embodiments, the rib is envisioned to have a single recess positioned so that the claw assembly can be configured to provide only one of the proximal stop mechanism or the redeployment lockout mechanism.

[0082] Referring to Figures 62–64, in certain embodiments, the distal stop mechanism can be incorporated within the actuator 720 rather than the handle assembly. That is, a handle assembly without the release button 110 described and illustrated with respect to Figures 23–28 can be provided. As illustrated, the actuator 720 includes a cantilever beam 722 positioned to restrict the distal advance of the actuator to a first deployed position for redeployable use of the retrieval bag. In the illustrated embodiment, the cantilever beam 722 is integral with the thumb loop 724 of the actuator 720 and can be pressed onto the actuator by interference pins and interference holes. The distal tip of the cantilever beam 722 contacts the upper handle during the deployment of the retrieval bag, restricting the advance of the actuator to the first deployed position (Figures 63, 64). To advance the actuator further, the cantilever beam 722 can be pushed downward to a position where it fits into an opening on the upper handle. The actuator 720 can then be advanced to its fully deployed position. In various embodiments, the thumb loop 720, including the cantilever beam 722, can be injection molded from a variety of polymer materials, including polycarbonate, nylon, ABS, and polypropylene.

[0083] Referring to Figures 65-66, in certain embodiments, the tissue retrieval system may include a tissue retrieval bag having a distal extension. The tissue retrieval bags described and illustrated with respect to Figures 1-6 have a cuff that has an open end supported by a support arm and extends substantially perpendicular to the longitudinal axis of the support arm to a closed end opposite the open end. In certain embodiments, the tissue retrieval system described herein may include a retrieval bag 20' formed such that the retrieval bag has a distal extension 22' that extends distally to its opening 24'. Preferably, the retrieval bag 20' having a distal extension provides a more streamlined shape that reduces the force required to retract the retrieval bag 20' into the introducer 3 tube (Figure 66) and reduces the force required to extract the detached retrieval bag through the patient's body wall compared to a tissue retrieval bag 20 without a distal extension. A recovery bag 20' having a distal extension 22' can make a larger volume recovery bag available for smaller tissue samples when it is partially retracted into the introducer tube and the opening is reversibly closed.

[0084] This application discloses certain aspects of various features of a redeployable tissue recovery system, but certain elements described herein are intended to be combined into certain embodiments of the tissue recovery system. For example, in one embodiment, the tissue recovery system may include a handle assembly having a deployment button 111 and an actuator 7 having a groove 131 as described above with reference to Figures 23B, 24B, 25B, 26B, 27B, 28B, 27C, and 28C, along with a bead stop 261 having a spring-biased clip as described above with reference to Figures 31B and 32B. However, in other embodiments, other beads, bead stops, latch members, and stop mechanisms described herein may be combined into the tissue recovery system within the scope of this application.

[0085] While this application discloses certain preferred embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the embodiments specifically disclosed to other alternative embodiments and / or uses of the invention and their obvious modifications and equivalents. Furthermore, various features of these inventions can be used alone or in combination with other features of these inventions not explicitly described above. In other words, the scope of the invention disclosed herein is not intended to be limited by the specific embodiments disclosed above, but rather should be determined solely by a proper reading of the following claims. [Explanation of Symbols]

[0086] 3 Introducer 7 Actuators 10. Tissue Recovery System 20 collection bags 50 bead

Claims

1. A tubular introducer having a proximal end, a distal end, and a lumen extending between the proximal and distal ends, An actuator having a proximal end and a distal end is slidable longitudinally within the lumen of the introducer. Tissue collection bag and The handle assembly at the proximal end of the introducer, Equipped with, In a redeployable configuration, the actuator is repeatedly slidable longitudinally between a proximal position and a first deployment position defined by the tissue retrieval bag being deployed from the distal end of the introducer and held by the introducer. The handle assembly includes a distal stop mechanism that restricts the distal movement of the actuator in the re-deployable configuration to the first deployed position, the distal stop mechanism being releaseable to selectively advance the actuator from the first deployed position to a second deployed position distal to the first deployed position. In the second deployment position, the tissue recovery bag is deployed from the introducer and released from the introducer. A tissue recovery system characterized by the following features.

2. The distal stop mechanism comprises a groove extending along a portion of the actuator, the groove having a proximal end wall and a release button positioned on the handle assembly, The release button comprises a latch tab positioned to slide and engage with the groove and to interfere with the proximal end wall of the groove when the actuator is in the first deployed position. The tissue recovery system according to claim 1.

3. The release button is positioned in a release position such that the latch tab is positioned away from alignment with the proximal end wall of the groove, so that the actuator can advance longitudinally distal to the first deployment position. The tissue recovery system according to claim 2.

4. The distal stop mechanism comprises a cantilever beam formed on the actuator adjacent to the proximal end of the actuator, the cantilever beam being biased to interfere with the handle assembly when the actuator is in the first deployed position, and positionable to allow distal forward movement of the actuator beyond the first deployed position. The tissue recovery system according to claim 1.

5. The handle assembly further comprises a proximal stop mechanism that limits the proximal movement of the actuator in the redeployable configuration to the proximal position. The tissue recovery system according to claim 1.

6. The handle assembly comprises a bore formed therein, the proximal stop mechanism comprises an actuator post positioned within the bore, the actuator comprises a surface having a ledge thereon, the ledge being engageable with the actuator post to prevent the actuator from moving proximal from the proximal position. The tissue recovery system according to claim 5.

7. The forward movement of the actuator to the second deployed position compresses the actuator post to a non-protruding position and releases the proximal stop mechanism so that the actuator can move proximal from the second deployed position to a position proximal to the proximal position. The tissue recovery system according to claim 6.

8. The actuator comprises a cam slope formed within the actuator and adjacent to its proximal end, the cam slope being positioned to compress the actuator post when the actuator is advanced distally to the second deployed position. The tissue recovery system according to claim 7.

9. The handle assembly further comprises a claw assembly that, when the actuator is pulled back from the second deployed position to a position proximal to the proximal position, restricts the proximal movement of the actuator to the proximal position in the redeployable configuration and prevents distal forward movement of the actuator in the longitudinal direction. The tissue recovery system according to claim 1.

10. The actuator comprises a longitudinally extended rib having a first recess formed within the actuator, the first recess having a distal wall, and the claw assembly comprises a claw pivotally coupled to the handle assembly and a claw spring that biases the claw to its central position. The tissue recovery system according to claim 9.

11. In the redeployable configuration, the claw is slidable along the longitudinal extension rib and is engageable with the distal wall of the first recess to prevent the actuator from moving proximal beyond the proximal position. The tissue recovery system according to claim 10.

12. The longitudinal extension rib comprises a second recess formed in the longitudinal extension rib distal to the first recess, the second recess having a proximal wall, and when the actuator is pulled back proximal to a position proximal to the proximal position from the second deployed position, the claw is positioned in the second recess and engages with the proximal wall to prevent distal movement of the actuator in the longitudinal direction. The tissue recovery system according to claim 10.

13. The longitudinal extension rib has a proximal end, and when the actuator is advanced distally to the second deployment position, the claw is positioned beyond the proximal end of the longitudinal extension rib, disengaging from the longitudinal extension rib. The tissue recovery system according to claim 12.

Images