Re-deployable tissue recovery bag

Abstract

A tissue recovery system, including a tissue recovery bag deployed by an actuator from an introducer and suspended in an open configuration by a support arm, is continuously redeployable between a partially or fully retracted configuration and a first deployed configuration used for procedures to recover multiple samples. The redeployable tissue recovery bag may include attachment tabs at the upper proximal portion where the bead is joined. The upper proximal portion is configured to significantly reduce stress concentration during the redeployment cycle of the tissue recovery bag. For example, the upper proximal portion can be aligned with the proximal edge of the tissue recovery bag. The upper proximal portion may further include an arcuate contour with a relatively large radius to reduce stress concentration.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims priority and the benefit of U.S. Provisional Patent Application Serial No. 63 / 455,536, filed on March 29, 2023, entitled "Redeployable Tissue Retrieval Bag", which is hereby incorporated by reference in its entirety.

[0002] (Technical Field) This application generally relates to devices and methods for capturing and retrieving tissue from body cavities, and more particularly, to a redeployable tissue retrieval bag for use in a specimen retrieval bag device.

Background Art

[0003] Laparoscopic surgery is typically performed through a trocar that allows 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, due to the limited range inherent in laparoscopic surgery and available laparoscopic surgical instruments, it can be difficult to remove such tissue from the body. For example, it may be desirable to introduce all surgical instruments through a single laparoscopic port of relatively small size in order to reduce patient invasiveness. Also, the removed tissue may include infected or cancerous tumors or organs, as well as blood, bile, and other fluids (all referred to herein as tissue), which can cause infection problems or other complications if left in the body.

[0004] It is desirable to grasp, capture, hold, and enclose the tissue while it is still within the body cavity, and then remove the enclosed tissue through a trocar or incision. It is also desirable to accommodate the tissue as quickly as possible while minimizing damage to the surgical site. Generally bulky and complex devices have several drawbacks, and are particularly inefficient in the limited space of the operating room and in access ports within the body cavity; therefore, generally compact, single-unit devices will also prove desirable.

[0005] In certain procedures, it may be desirable to remove multiple tissue samples from a body cavity in a single procedure for further analysis. For example, in patients undergoing cancer treatment, it is common practice to sequentially remove lymph nodes to determine the extent of cancer spread or recurrence within the patient. To properly identify lymph nodes from a specific area of ​​the body, it is important to remove lymph nodes sequentially, sometimes one at a time, from the patient to accurately determine the stage of the cancer. Surgeons typically begin by removing the sentinel lymph node (i.e., the lymph node closest to the tumor) and then proceed to other lymph nodes in the surrounding area. In some procedures, to minimize the number of lymph nodes removed from the patient, each lymph node removed from the patient is immediately analyzed by a pathologist during surgery for the presence of cancer before the next lymph node is removed. Therefore, it may be desirable that the tissue retrieval device be repositionable to obtain multiple tissue samples in a single procedure. [Overview of the Initiative]

[0006] In a particular embodiment, a tissue recovery system is provided. The tissue recovery system comprises a tubular introducer, an actuator, a pair of support arms, a tissue recovery bag, and a bead. The tubular introducer has a proximal end and a distal end, with a central longitudinal axis defined between the proximal and distal ends. The tubular introducer has 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 pair of support arms extends distally from the distal end of the actuator along the central longitudinal axis. The tissue recovery bag is removably coupled to the support arms. The tissue recovery bag has an open end and a closed end opposite the open end. The tissue recovery bag comprises a cuff and an upper proximal portion. The cuff extends longitudinally at the open end between the proximal end of the open end and the distal end of the open end. The cuff is configured to receive the pair of support arms. The upper proximal portion is positioned at the proximal end of the cuff and extends laterally with respect to the longitudinal axis, approaching the longitudinal direction and moving away from the closed end. The bead is coupled to the upper proximal portion. The bead is configured to slidably receive a pair of support arms.

[0007] In a particular embodiment, a tissue recovery system is provided herein. The tissue recovery system comprises a tubular introducer, an actuator, a pair of support arms, a tissue recovery bag, and a bead. The tubular introducer has a proximal end and a distal end, with a central longitudinal axis defined between the proximal and distal ends. The tubular introducer has 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. A pair of support arms extends distally from the distal end of the actuator along the central longitudinal axis. The tissue recovery bag is detachably coupled to the support arms. The tissue recovery bag has an open end and a closed end opposite the open end, with a depth axis extending perpendicular to the central longitudinal axis from the open end to the closed end. The open end extends from the proximal end to the distal end along the central longitudinal axis. The tissue retrieval bag comprises a distal end, a proximal end, and an upper proximal portion. The distal margin extends from the distal end of the open end to the closed end. The proximal margin extends from the proximal end of the open end to the closed end. The proximal margin extends laterally with respect to the central longitudinal axis. The upper proximal portion is located at the proximal end of the open end and extends collinearly with the proximal margin, away from the closed end with respect to the depth axis. A bead is coupled to the upper proximal portion and is configured to slidably receive a pair of support arms.

[0008] In a particular embodiment, a tissue recovery bag for use in a redeployable tissue recovery system is provided herein. The tissue recovery bag comprises an open end, a closed end, a distal margin, a proximal margin, a mounting tab, and a bead. The open end extends along the central longitudinal axis from the proximal end to the distal end of the open end. The closed end is opposite the open end and defines a depth axis that extends from the open end to the closed end perpendicular to the central longitudinal axis. The distal margin extends from the distal end of the open end to the closed end. The proximal margin extends from the proximal end of the open end to the closed end. The proximal margin extends laterally with respect to the central longitudinal axis. The mounting tab is located at the proximal end of the open end and extends collinearly with the proximal margin away from the closed end with respect to the depth axis. The bead is coupled to the mounting tab. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of one embodiment of a tissue recovery system having one embodiment of a tissue recovery bag in a first deployment configuration. [Figure 2] Figure 1 is a side view of the tissue recovery system. [Figure 3] This is a perspective view of one embodiment of a tissue recovery system having one embodiment of a tissue recovery bag in a storage configuration. [Figure 4] Figure 1 is a top view of the tissue retrieval system, with the tissue retrieval bag deployed and positioned through the access port at the surgical site. [Figure 5] Figure 1 is a top view of the tissue retrieval system, positioned via an access port at the surgical site, with the tissue retrieval bag in a re-deployable, closed configuration. [Figure 6] Figure 1 is a top view of the tissue retrieval system, with the tissue retrieval bag in its fully deployed configuration and positioned through the access port at the surgical site. [Figure 7] Figure 1 is a top view of the tissue retrieval system, with the tissue retrieval bag fully deployed and in a tightened configuration, positioned through the access port at the surgical site. [Figure 8] Figure 1 is a side view of one embodiment of the tissue recovery bag and bead assembly of the tissue recovery system. [Figure 9] Figure 8 is a side view of one embodiment of the tissue recovery bag assembly. [Figure 10] This is a side view of one embodiment of a conventional tissue recovery bag and bead assembly. [Figure 11] Figure 10 is a side view of one embodiment of a conventional tissue recovery bag assembly. [Figure 12] Figure 9 is a schematic diagram of a sheet of material cut according to a die-cut pattern for a tissue collection bag. [Figure 13] This is a schematic diagram of a partially formed tissue recovery bag formed according to the die-cut pattern in Figure 12. [Figure 14] This is a schematic diagram of a sheet of material cut according to a die-cut pattern of another embodiment of the tissue recovery bag. [Figure 15] This is a schematic diagram of a partially formed tissue recovery bag formed according to the die-cut pattern in Figure 14. [Figure 16] This is a schematic diagram of a sheet of material cut according to a die-cut pattern of another embodiment of the tissue recovery bag. [Figure 17] This is a schematic diagram of a partially formed tissue recovery bag, which is formed according to the die-cut pattern in Figure 16. [Figure 18] This is a schematic diagram of a sheet of material cut according to a die-cut pattern of another embodiment of the tissue recovery bag. [Figure 19] This is a schematic diagram of a partially formed tissue recovery bag, which is formed according to the die-cut pattern shown in Figure 18. [Figure 20] This is a side view of another embodiment of the tissue collection bag. [Figure 21] This is a schematic diagram of a sheet of material cut according to a die-cut pattern of one embodiment of a tissue recovery bag. [Figure 22] This is a schematic diagram of a partially formed tissue recovery bag formed according to the die-cut pattern in Figure 21. [Figure 23] Side view of an embodiment of a tissue collection bag formed according to the cut pattern of FIG. 21. [Figure 24] Side view of an embodiment of a tissue collection bag and bead assembly formed according to the cut pattern of FIG. 21. [Figure 25] Schematic view of a sheet of material cut according to the cut pattern of an embodiment of a tissue collection bag. [Figure 26] Schematic view of a reinforcing tab for use with the cut pattern of FIG. 25. [Figure 27] Schematic view of a partially formed tissue collection bag formed according to the cut pattern of FIG. 25 and the reinforcing tab of FIG. 26. [Figure 28] Schematic view of a partially formed tissue collection bag formed according to the cut pattern of FIG. 25 and the reinforcing tab of FIG. 26, having a formed cuff and cord loop. [Figure 29] Side view of an embodiment of a tissue collection bag formed according to the cut pattern of FIG. 25 and the reinforcing tab of FIG. 26. [Figure 30] Side view of an embodiment of a tissue collection bag and bead assembly formed according to the cut pattern of FIG. 25 and the reinforcing tab of FIG. 26. [Figure 31] Schematic view of a sheet of material cut according to the cut pattern of an embodiment of a tissue collection bag. [Figure 32] Schematic view of a partially formed tissue collection bag formed according to the cut pattern of FIG. 31. [Figure 33] Side view of an embodiment of a tissue collection bag formed according to the cut pattern of FIG. 31. [Figure 34] Side view of an embodiment of a tissue collection bag and bead assembly formed according to the cut pattern of FIG. 31. [Figure 35] Schematic view of a sheet of material cut according to the cut pattern of an embodiment of a tissue collection bag. [Figure 36] This is a schematic diagram of a reinforcing ring for use with the die-cut pattern shown in Figure 35. [Figure 37] This is a schematic diagram of a partially formed tissue recovery bag formed according to the die-cut pattern in Figure 35 and the reinforcing ring in Figure 36. [Figure 38] This is a schematic diagram of a partially formed tissue recovery bag, which has a formed cuff and cord loop, formed according to the die-cut pattern of Figure 35 and the reinforcing ring of Figure 36. [Figure 39] This is a side view of an embodiment of a tissue recovery bag formed according to the die-cut pattern in Figure 35 and the reinforcing ring in Figure 36. [Figure 40] This is a side view of an embodiment of a tissue recovery bag and bead assembly formed according to the die-cut pattern in Figure 35 and the reinforcing ring in Figure 36. [Figure 41] Figure 12 is a schematic diagram of a partially formed tissue recovery bag and a reinforcing disc placed thereon, formed according to the die-cut pattern. [Figure 42] This is a side view of an embodiment of a tissue recovery bag and a reinforcing disc formed according to the die-cut pattern of Figure 41. [Modes for carrying out the invention]

[0010] Referring to Figures 1 and 2, one embodiment of the tissue recovery system 10 is shown. The exemplary tissue recovery system can be used to contain and extract tissue specimens excised from the body. Specific embodiments of the tissue recovery system are described in U.S. Patent No. 11,547,428, titled “REDEPLOYABLE TISSUE RETRIEVAL SYSTEM”, U.S. Patent No. 8,721,658, titled “TISSUE RETRIEVAL SYSTEM”, and U.S. Patent No. 9,033,995, titled “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 collect and withdraw multiple small tissue specimens during a surgical procedure without removing the retrieval bag from the device, while also enabling the extraction of larger tissue specimens by tightening the retrieval bag and then removing the retrieval bag from the introducer. In some procedures, the surgeon may only need the ability to sequentially collect and withdraw small specimens from the patient. In some procedures, the surgeon may need the ability to sequentially collect and withdraw multiple small tissue specimens, as well as collect and withdraw larger specimens. In other procedures, the surgeon may only need to collect and withdraw large tissue specimens. Since the retrieval systems described herein meet many different surgical requirements, a hospital or surgical center using these systems can limit the number of retrieval system models it keeps in stock for its surgical needs.

[0012] The exemplary tissue retrieval system can preferably be used for specific procedures to sequentially collect and withdraw multiple excised small tissue specimens. Advantageously, in certain embodiments of the tissue retrieval system described herein, it may be possible to use a single retrieval system to sequentially remove multiple lymph nodes during a procedure.

[0013] Referring to Figures 1 and 2, in certain embodiments, the tissue retrieval system 10 includes a retrieval bag 20 at its distal end, which provides a receptacle for the tissue specimen. The retrieval bag 20 may have an open end and a closed end opposite the open end. The retrieval bag 20 may further include a cuff 124 formed at the open end to receive a pair of support arms 40 for suspending the retrieval bag 20, and a cord loop for selectively tightening the open end of the retrieval bag. In various embodiments, the retrieval bag may be formed from ripstop nylon and polyurethane laminate, polyurethane, or a combination of both materials. For example, the retrieval bag may be formed from ripstop nylon and polyurethane laminate, and a polyurethane reinforcement may be included at the tip of the retrieval bag to increase the burst strength and puncture resistance of the retrieval bag. The reinforcement may consist of ripstop nylon or ripstop nylon and polyurethane laminate. Instead of ripstop nylon and polyurethane laminate, ripstop nylon may be coated with polyurethane.

[0014] In procedures 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 and to prevent contamination of the body cavity and cavity wall while the collection bag 20 is withdrawn from the body cavity. Once the collection bag is withdrawn from the body cavity, it can be opened again, the tissue specimens can be removed, labeled, and then sent to a pathologist for analysis. The collection bag is then completely stored in the introducer tube and can be redeployed within the patient for subsequent collection and retrieval of the next target tissue specimen.

[0015] The tissue recovery system 10 can also be used in procedures to remove large tissue specimens, such as the gallbladder or kidney, from a body cavity. In these procedures, the recovery bag 20 can be fully tightened and closed and detached from the system for subsequent withdrawal of the recovery bag 20 through the body wall. In some procedures, such as those associated with the resection of cancerous tissue, it may be desirable to first remove small tissue specimens, such as lymph nodes, sequentially, and then remove larger tissue specimens. In this case, the tissue recovery system 10 allows the recovery bag to be reversibly closed for sequential removal of smaller tissue specimens and to be fully tightened and closed and detached for removal of larger tissue specimens.

[0016] Referring to Figures 1 to 7, specific embodiments of the tissue retrieval system 10 are shown in various configurations for use in procedures to retrieve multiple tissue specimens in a single procedure. Referring to Figures 1 and 2, the tissue retrieval system 10 is shown in a first deployed state. In an exemplary embodiment, the tissue retrieval system comprises an introducer 3 and an actuator 7 or actuation rod. In one embodiment, the introducer 3 has a tubular configuration with 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 so that it is 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 to a specific location. In some embodiments, the tissue retrieval system 10 may include a relatively long introducer, such as an introducer 3 with a length of 45 cm, to improve access to the surgical site.

[0017] The handle assembly 5 in the exemplary embodiment may include a compact handle member that can be adapted to be positioned adjacent to other surgical instruments at a single-port laparoscopic surgical site. Thus, in some embodiments, the tissue retrieval system is adapted to be used during a single incision laparoscopic procedure. In other embodiments, the handle assembly may include a pair of finger loops or grips formed together with or otherwise attached to the handle assembly 5, which can be used to hold or stabilize the introducer 3 as desired.

[0018] In an exemplary embodiment of the tissue retrieval system 10, the introducer 3 has a generally open proximal and distal end, thereby facilitating access to the hollow lumen. As shown, the actuator 7 extends into the hollow lumen from its open proximal end, and at least a portion of the actuator 7 is slidably movable within the hollow lumen of the introducer 3. Referring to Figure 2, the actuator rod can be pulled out to a proximal position for insertion into the surgical site via an access port such as a trocar. When the actuator 7 is in the proximal position, the tissue retrieval bag 20 is in a housing configuration positioned within the hollow lumen of the introducer 3. In one embodiment, the actuator 7 has a handle, such as a thumb loop, extending from its proximal end. The handle provides a graspable 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 3) and a first deployed state of the tissue retrieval system (shown in Figure 1).

[0019] Referring to Figures 4 to 7, an exemplary method for using an exemplary embodiment of the tissue recovery system 10 to recover a tissue specimen at the surgical site is shown. In certain embodiments, the tissue recovery system may be provided in either a retracted configuration (Figure 3) or a first unfolded configuration (Figure 1). In some embodiments, 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 to ensure that the recovery bag 20 maintains its original configuration and is easily unfolded during surgical use. During clinical use, an access device such as a trocar 100, which includes a trocar cannula and a trocar seal housing, is positioned through the body wall W, with the trocar cannula initially positioned across the body wall W. If the tissue recovery system 10 is provided in a first unfolded configuration, a nurse or surgeon configures the tissue recovery system in a retracted configuration (Figure 3) by fully retracting the recovery bag 20 within the introducer tube 3 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 seal housing and trocar cannula until the distal end of the introducer 3 tube extends beyond the distal end of the trocar cannula. The retrieval bag 20 is then deployed from within the introducer 3 tube and into the body cavity by advancing the actuator distally to a first deployment position (Figure 3).

[0020] Continuing to refer to Figure 4, when expanded into the body cavity, the retrieval bag 20 in the first deployment configuration is suspended and held open by two support arms 40 extending into the cuff at the open end of the retrieval bag. In the exemplary embodiment, the retrieval bag includes a bead 50 attached to the proximal portion of the cuff from 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 engaging 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, preventing the release of the retrieval bag 20 from the support arms, and the retaining latch 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 (Figure 3) with the actuator 7 pulled out to a proximal position for subsequent insertion via the trocar. When engaged with the bead 50, the retaining latch also allows the retrieval bag 20 to be partially retracted into the introducer tube (Figure 5) into a redeployable closed configuration, and allows the retrieval bag to be reversibly closed after opening. Thus, by repeatedly opening and closing the tissue retrieval bag 20, the actuator can be advanced to a first deployed position (Figure 4), and then retracted towards a proximal position (Figure 5) to position the tissue retrieval bag in a redeployable closed configuration, thereby accommodating multiple small tissue specimens in a single procedure for later retrieval from the patient.

[0021] Referring to Figure 5, once the small tissue specimen is positioned in the retrieval bag, partial storage and closure of the retrieval bag 20 is achieved by retracting the actuator 7 into the introducer 3 tube until the support arm 40 and cuff are retracted into the introducer 3 tube, leaving the distal portion of the retrieval bag 20 with the contained tissue outside the introducer 3 tube. In certain embodiments, the actuator may be equipped with a visual indicator such as a dot 9. This visual indicator can be positioned on the actuator so as to be exposed at the proximal end of the introducer 3 tube when the retrieval bag 20 is closed. In certain embodiments, the dot 9 is pad-printed and serves as an indicator to show the surgeon that the actuator has been sufficiently retracted to close the bag. The tissue specimen can then be drawn out from the surgical site across the body wall using various techniques. For example, the tissue retrieval system 10 can be drawn out through the trocar while the trocar remains positioned across the body wall, or the tissue retrieval system can be drawn out directly through the body wall after the trocar has been withdrawn from the patient. For very small tissue specimens, the entire retrieval bag 20 containing the specimen can be withdrawn into the introducer tube. In this case, the tissue retrieval system can be withdrawn through the trocar while the trocar remains positioned across the body wall.

[0022] Once the tissue retrieval system 10 is withdrawn from the surgical site, the actuator 7 is advanced distally to a first deployment position (Figure 1) to allow the tissue sample to be removed for analysis. If a smaller tissue sample is desired, the actuator 7 can be withdrawn to a proximal position (Figure 3) and reintroduced to the surgical site as described above. In certain embodiments, the tissue retrieval system may include a stopping mechanism that restricts the movement of the actuator between the proximal position and the first deployment position until it is desired that the tissue retrieval bag 20 be separated from the actuator 7. Advantageously, these stopping mechanisms can reduce the possibility of the tissue retrieval bag being inadvertently fully deployed before all of the desired tissue sample has been collected for analysis.

[0023] The tissue retrieval system 10 can also be used in procedures to retrieve relatively large tissue specimens, such as the gallbladder, appendix, or kidney. In these procedures, preferably, while the tissue retrieval bag is in the first deployment configuration (Figure 4) during the placement of a large tissue specimen, such as the gallbladder, the retaining latch prevents the retrieval bag from moving unintentionally relative to the support arm and actuator. Once the large specimen is placed in the tissue retrieval bag, it is desirable to tighten the retrieval bag to completely detach it from the introducer and leave the tightened retrieval bag in the body cavity. If the procedure requires the sequential removal of small tissue specimens, such as lymph nodes, followed by the removal of a larger tissue specimen, the tightening and detachment of the retrieval bag should be completed after the sequential removal of the small tissue specimens. Once the retrieval bag is tightened and detached from the introducer, the surgeon can remove the trocar from the body wall and pull the retrieval bag through the body wall.

[0024] In certain embodiments, the tissue retrieval system 10 can be selectively activated from a first deployed configuration (Figure 4) to a fully deployed configuration (Figure 6) for the actuator and tissue retrieval bag. 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 specimen is placed in the retrieval bag, the surgeon activates the release mechanism, for example, by pressing the release button on the handle assembly. Activation of the release mechanism allows the actuator to advance distally beyond the first deployed position to a second or fully deployed position (Figure 6). When the actuator is advanced to its fully deployed position, the distal ends of the bead and retaining latch are positioned outside the distal end of the introducer tube.

[0025] Referring to Figures 6 and 7, in certain embodiments, the tissue recovery system 10 may include a stopping mechanism to prevent the bead from being reintroduced to the distal end of the introducer 3 when the actuator 7 is advanced to a fully deployed position. For example, in the exemplary embodiment, the tissue recovery system 10 includes a bead stop 60 positioned between the actuator 7 and the bead 50. 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 and closes the distal end of the introducer 3. This closing prevents the fully deployed bead and recovery bag from being pulled into the introducer tube. This closing also serves as a support surface for which the support arm is pulled out from the cuff of the tissue recovery bag 20 when the actuator is pulled proximally from the fully deployed position, and the tissue recovery bag 20 is tightened (Figure 7). When the recovery bag is tightened, a small loop of the cord loop 42 is exposed near the proximal end of the introducer 3 tube.

[0026] In certain embodiments, the tissue recovery system includes a cord loop 42 positioned to selectively tighten the open end of the tissue recovery bag to form a tightened configuration. The cord loop 42 extends through the cuff of the open end of the tissue recovery bag 20 and may extend along the receiving channel of the actuator in close proximity to the introducer. The cord loop 42 may be removably coupled to the actuator. In certain embodiments, the cord loop is sized 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 length of the cord loop 42 is sized such that it allows for tightening of the recovery bag and exposure of the cord loop 42 on the actuator after tightening. When the recovery bag is tightened and closed, the cord loop 42 is fully tensed. Before the cord loop 42 is fully tensed when the recovery bag is tightened, the cord loop 42 is fully retracted into 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 during the continuous intake and withdrawal of multiple small tissue specimens (Figures 3-5). In these embodiments, the cord loop 42 is exposed to the surgeon only when the cord loop is fully stretched and the retrieval bag is tightened and closed (Figure 7). This feature prevents the surgeon from inadvertently grasping, cutting, releasing, or pulling the cord loop during use of the device. The cord loop can be housed within the introducer tube in a non-stretched state, with a portion of the cord loop folded and stored in the receiving channel on the underside of the actuator.

[0027] The cord loop 42 can provide an ergonomic and high-strength means for grasping and withdrawing the retrieval bag through the abdominal wall. Since the cord is formed in a single cord loop, there are no limitations in that the cord loop can be grasped manually. Furthermore, the cord loop provides a robust means for withdrawing the retrieval bag through the body wall, as the two strands of cord absorb the tension applied by the surgeon. For example, if a surgeon applies a 20-pound tensile force to the cord loop when withdrawing the retrieval bag, each strand of cord will be pulled with a force of 10 pounds. Certain other retrieval systems include relatively small loops that are difficult to grasp by hand. Other retrieval systems also include small loops connected to a single strand of cord or line such that if a surgeon applies a 20-pound tensile force, a 20-pound tensile force is applied to the cord. In some cases, the single strands of cord or line in such other retrieval systems may fail during the withdrawal of the retrieval bag.

[0028] Another advantage provided by the cord loop 42 is that it is relatively short after the retrieval bag is tightened, making the cord easy to manage and facilitating the retrieval bag's removal through the body wall. In certain embodiments of the tissue retrieval system described herein, the length of the cord loop with the retrieval bag tightened is approximately 14 inches. Other retrieval systems may have cords longer than approximately 25 inches after the retrieval bag is tightened, making the cord difficult to handle while removing the retrieval bag through the body wall, thus cumbersome to manage and use.

[0029] Referring to Figure 7, once the tissue retrieval bag 20 is tightened, there are at least two techniques for withdrawing the tightened retrieval bag from the body cavity. 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 actuator's holding slot.

[0030] Referring to Figure 7, when the cord loop is detached from the actuator, the device, trocar seal, and cannula can be withdrawn from the body wall, leaving the retrieval bag 20 and the cord loop 42 positioned across the body wall within the body cavity. Next, the bead can be used as a dilator to assist in the movement of the retrieval bag through the layer of tissue fibers in the body wall, allowing the neck of the retrieval bag to be withdrawn through the body wall. Once the neck of the retrieval bag has crossed the body wall, the retrieval bag can be reopened by manually grasping the closed end of the retrieval bag and the bead and sliding the bead along the cord. Subsequently, standard open cavity instruments and laparoscopic instruments such as forceps, grabbers, and suction probes can be used to access the retrieval bag, remove or compress the contents, and assist in its complete withdrawal from the body cavity. Once most of the contents have been removed, the retrieval bag can be closed by manually grasping the open end of the retrieval bag and the bead and sliding the bead along the cord. Finally, the cord loop can be manually grasped, allowing the retrieval bag to be completely withdrawn from the body cavity. In some procedures, the surgeon can pull the retrieval bag through the body wall without reopening it.

[0031] A second method for withdrawing the retrieval bag 20 from the body cavity can be used for small tissue specimens, such as a small gallbladder, placed inside the retrieval bag, which are unlikely to require aspiration, compression, or removal from the retrieval bag before being withdrawn through the body wall. In this case, the cord loop can be left attached to the actuator, and the entire device, along with the trocar seal and cannula, can be simultaneously withdrawn from the body cavity through the body wall.

[0032] In certain embodiments, the bead 50 comprises a pair of channels through which a support arm slides. The bead 50 may further comprise a hole through which a cord loop extends, which frictionally engages with the cord loop to allow the recovery bag to be tightened and closed as needed when the recovery bag is completely detached from the actuator and introducer, and to be opened again. The bead may also be configured to engage releasably with a retaining latch. In certain embodiments, the bead 50 comprises a recess and a ledge positioned within the recess to engage with the distal end of a retaining latch. In certain embodiments, the bead 50 is injection molded from polycarbonate, and in other embodiments, the bead 50 may be formed from other materials such as nylon, ABS, and polyester.

[0033] Continuing to refer to Figure 7, in certain embodiments, the bead 50 is configured to facilitate the withdrawal of the retrieval bag that has been clamped through the body wall. In certain embodiments, the proximal end of the bead 50 may have a blunt, tapered, or arc-shaped surface to facilitate the withdrawal of the bead through the body wall. Thus, the bead can expand the muscle and tissue fibers of the body wall during the withdrawal of the retrieval bag. Advantageously, as the bead crosses the body wall, the clamped cuff and the remainder of the retrieval bag can easily follow. A retrieval system without a bead requires the clamped cuff of the retrieval bag to be pulled directly into the body wall, in which case the clamped cuff may catch on the body wall, resulting in increased withdrawal force when the retrieval bag is withdrawn.

[0034] In certain embodiments, the bead 50 includes a passage, bore, or hole through which the cord loop passes, which frictionally engages with the cord loop, so that the recovery bag can be tightened and closed and reopened as needed after the recovery bag has been detached from the introducer. Thus, when the neck of the recovery bag crosses the body wall during the withdrawal of the recovery bag from the body cavity, the recovery bag can be advantageously reopened easily to allow access for removal or compression of its contents. Conventional recovery bags without a bead are very difficult or impossible to reopen after the recovery bag has been closed.

[0035] Referring to Figure 8, in a particular embodiment, the bead 50 may comprise a two-part assembly comprising a bead body 51 and an annular clamp 53 positioned around a portion of the bead body. A portion of the tissue recovery bag can be positioned between the bead body 51 and the clamp 53 to bond the tissue recovery bag to the bead 50. The recovery bag can be further secured to the bead body and / or clamp by various bonding techniques such as chemical adhesive bonding, ultrasonic welding, heat sealing, or other chemical, thermal, or mechanical bonding processes. 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.

[0036] In contrast to a tissue retrieval system configured for a single deployment, the tissue bag 20 for use in a redeployable tissue retrieval system 10 is preferably configured to resist tearing or rupture due to material fatigue or relatively high loads that may be encountered over multiple tensile loading cycles while the tissue retrieval bag 20 is coupled to and maintained by the introducer. When the surgeon withdraws the introducer 3 with the closed retrieval bag 20 through the trocar, or alternatively, directly through the incision, relatively high tensile forces can be applied to the bead 50 through the retaining latch and through the proximal portion of the retrieval bag 20 to which the bead 50 is attached. The tensile force typically increases as the distal portion of the bag 20 containing the specimen comes into contact with either the distal end of the trocar or the anterior side of the incision. Larger tissue specimens tend to induce higher tensile forces than smaller tissue specimens. High tensile forces generate correspondingly high stresses in the proximal section of the retrieval bag 20, particularly in the portion to which the bead 50 is attached and the portion of the retrieval bag 20 extending directly beyond the bead 50.

[0037] When the retrieval bag 20 is partially retracted into the introducer 3 tube, the opening of the bag 20 is closed and it is retracted into the introducer 3 tube. Once the retrieval system is retracted, the portion of the retrieval bag 20 containing the specimen is retracted into the distal end of the trocar or into the incision. In this configuration, since the bead 50, the portion of the retrieval bag 20 to which the bead is attached, and the cuff of the retrieval bag are located within the introducer 3 tube, a tensile force is applied to the retrieval bag 20 along the central longitudinal axis of the introducer 3 tube. This longitudinal tensile force passes through the portion of the retrieval bag 20 to which the bead 50 is attached and translates along the length of the retrieval bag 20 between the portion to which the bead 50 is attached and the portion of the retrieval bag 20 at its distal end where the specimen is located. During typical surgical use, almost all of the stress generated in the recovery bag beyond the position where the bead 50 is attached extends along the proximal portion of the recovery bag 20, while the stress across the cuff portion of the recovery bag 20 is minimal.

[0038] The stress distribution when the retrieval bag 20 is in a closed configuration for the extraction of small tissue specimens, such as lymph nodes, can be significantly different from the stress distribution when the retrieval bag 20 is in a tightened configuration for the extraction of larger tissue specimens, such as gallbladder. When the retrieval bag 20 is tightened and closed and detached from the actuator 7, the surgeon applies a tensile force to the cord loop 42. This tensile force acts through the cuff and is evenly distributed across the width of the retrieval bag 20 between the cuff and the distal end of the bag containing the specimen. In this case, there is virtually no tensile force through the bead 50, the portion of the retrieval bag 20 to which the bead is attached, or the portion of the retrieval bag 20 extending directly beyond the bead. Thus, the stress induced in the tightened retrieval bag 20 is evenly distributed within the cuff and across the entire width of the retrieval bag 20 between the cuff and the end of the retrieval bag 20. The tensile force applied by the surgeon when extracting the introducer with a closed retrieval bag 20 is typically lower than the tensile force applied when extracting a tightened retrieval bag 20, due to differences in the size or volume of the specimen being extracted. However, in both examples, the force can be large enough to cause the retrieval bag 20 to rupture. A tissue retrieval system that is not redeployable and is therefore designed to retrieve the specimen only after the retrieval bag has been tightened and removed from the introducer includes a retrieval bag configuration designed to withstand the associated tensile forces, but is not designed to withstand the tensile forces that a redeployable retrieval bag may experience while a closed retrieval bag attached to an introducer is being pulled out.

[0039] In certain embodiments, the tissue retrieval system described herein is desirable to include a practical and easily manufactured retrieval bag configured to withstand the tensile forces encountered during the various operating conditions encountered by the redeployable tissue retrieval bag. Accordingly, the redeployable tissue retrieval bag is desirable to be configured to withstand the tensile forces induced by the surgeon when withdrawing small specimens such as lymph nodes while the retrieval bag is attached to the introducer in a closed configuration, and to withstand the tensile forces induced by the surgeon when withdrawing larger specimens such as gallbladder or kidneys while the retrieval bag is detached from the introducer in a clamped configuration.

[0040] In various embodiments, the redeployable tissue retrieval bag 20 can be configured to withstand typical tensile forces induced by a surgeon during the successive withdrawal of multiple small specimens while the retrieval bag 20 is in a closed configuration and attached to the actuator 7, and can also be configured to withstand typical tensile forces induced by a surgeon during the withdrawal of a larger specimen while the retrieval bag 20 is in a tightened configuration and detached from the actuator 7. In certain embodiments, the redeployable tissue retrieval bag 20 for use with the tissue retrieval system described herein may include a reinforced proximal upper portion to which a bead 50 is attached, allowing for reversible partial storage of the retrieval bag 20 into the introducer 3 tube and closure of the retrieval bag 20 to accommodate small specimens for subsequent withdrawal from the patient.

[0041] Referring to Figures 8-9, embodiments of the redeployable tissue recovery bag 20 are shown. Figure 8 shows the tissue recovery bag 20 with a bead 50 joined by an annular clamp 53. Figure 9 shows the tissue recovery bag 20 with the bead 50 removed. In the exemplary embodiment, the tissue recovery bag 20 comprises an open end 120 and a closed end 122 opposite the open end. A cuff 124 extends along the open end 120 and extends longitudinally from the proximal end to the distal end with respect to the central longitudinal axis L of the introducer when the tissue recovery bag 20 is in the stowed or deployed position. The cuff 124 is sized and configured to accommodate the support arm and the cord loop 42 within it. The depth axis D extends perpendicular to the central longitudinal axis L between the open end 120 and the closed end 122.

[0042] Continuing to refer to Figures 8-9, the exemplary embodiment of the tissue recovery bag further includes a distal edge 126 extending from the distal end of the cuff 124 at the open end 120 to the closed end 122. The proximal edge 128 extends from the proximal end of the cuff 124 to the closed end 122. In the exemplary embodiment, the recovery bag 20 is formed from a sheet of material having a fold in the sheet that defines the distal edge 126 and a welded seal that defines the closed end 122 and the proximal edge 128. In other embodiments, the proximal edge may be formed from a folded sheet and the distal edge may be welded. In yet another embodiment, the tissue recovery bag may be formed from a plurality of sheets bonded or welded together.

[0043] Continuing to refer to Figures 8-9, an exemplary embodiment of the tissue recovery bag 20 further comprises an attachment tab or a proximal upper portion 130. In the exemplary embodiment, the proximal upper portion 130 is located at the open end 120 and extends laterally proximal to the central longitudinal axis L and away from the closed end 122 with respect to the depth axis D. In a particular embodiment, the proximal upper portion is aligned with or extends along an axis that is collinear with the axis defined by the proximal edge portion 128. As shown in Figure 8, the bead 50 is coupled to the proximal upper portion 130.

[0044] Continuing to refer to Figures 8-9, the proximal upper portion 130 comprises a lower edge 132 and an upper edge 134 opposite the lower edge. The lower edge 132 can be aligned with the proximal edge 128 of the tissue recovery bag 20. In the exemplary embodiment, the lower edge 132 is collinear with the proximal edge 128. For example, in a particular embodiment, the lower edge 132 can be formed by a continuity of the weld seam of the proximal edge 128 on the proximal upper portion 130. Advantageously, such alignment or collinear arrangement of the proximal upper portion 130 to which the bead 50 is attached can significantly reduce stress concentrations that may otherwise occur adjacent to the bead 50 in the redeployable tissue recovery bag.

[0045] Referring to Figures 10-11, exemplary embodiments of a prior art tissue recovery bag 220 are shown. Figure 10 shows the tissue recovery bag 220 with a bead 250 attached thereto. Figure 11 shows the tissue recovery bag 220 with the bead 250 removed. In the exemplary embodiment, the tissue recovery bag 220 comprises an open end 210 and a closed end 222 opposite the open end. A cuff 224 extends along the open end 210 and extends longitudinally from the proximal end to the distal end with respect to the central longitudinal axis L of the introducer when the tissue recovery bag 220 is in the stowed or deployed position. The cuff 224 is sized and configured to receive a support arm and a cord loop.

[0046] Continuing to refer to Figures 10-11, in the exemplary prior art tissue recovery bag 220, the bead 250 is coupled to the proximal portion 230 of the recovery bag 220, which extends longitudinally from the proximal end of the cuff 224 close to the central longitudinal axis L. Thus, the proximal portion 230 extends longitudinally parallel to the cuff 224 and the open end of the recovery bag 220. The exemplary recovery bag 220 includes a proximal edge portion 228 that extends lateral to the central longitudinal axis L from the proximal end of the open end 210 to the closed end 222. In the exemplary prior art embodiment, the proximal portion 230 is integrated with the proximal edge portion 228 of the recovery bag via a radius 232. In an exemplary embodiment of a tissue retrieval bag 220 for single deployment, the proximal portion 230 extends longitudinally with respect to the central longitudinal axis L to allow for the installation of a support arm and to align with the longitudinal axis of the support arm and the introducer tube. The radius 232 that integrates the longitudinal proximal portion 230 with the proximal edge 228 of the retrieval bag represents a stress elevation that causes stress concentration at the radial position. If this exemplary embodiment of the prior art retrieval bag 220 is used in a redeployable tissue retrieval system and subsequently partially housed within the introducer tube to close and contain the open end 210, the stress concentration at radius 232 could cause the retrieval bag to rupture or tear with relatively little force when the surgeon attempts to remove the contained specimen.

[0047] Referring to Figures 12-13, schematic diagrams of a sheet of material 18 are shown as die-cut patterns (Figure 12) and initial cuts that partially form a recovery bag 20 as shown in Figures 8-9 (Figure 13). To form the recovery bag 20 described herein for use with a redeployable tissue recovery system, a sheet of material 18 can be cut to define an open end 120 having a cuff 124.

[0048] Continuing to refer to Figures 12-13, in the exemplary embodiment, the recovery bag 20 includes a proximal upper portion 130 configured to provide an attachment tab for the bead, which provides relatively high tensile strength during the deployment cycle. For example, the proximal upper portion 130 includes a lower edge 132 that is substantially collinear or aligned with the proximal edge of the tissue recovery bag. Thus, the proximal upper portion 130 or the lower edge 132 of the attachment tab is configured to provide relatively high tensile strength with substantially no stress concentration. Since the alignment or collinear arrangement of the lower edge 132 of the upper proximal portion 130 can withstand relatively high tensile forces, in certain embodiments, it is desirable that the upper edge 134 of the upper proximal portion 130 is also configured to minimize stress concentration in the arcuate transition region from the upper proximal portion 130 to the cuff 124, in order to reduce the tendency of the recovery bag 20 to burst. In certain embodiments, the proximal upper portion 130 further includes upper edge portions 134 that have relatively large radii on each side, extending slightly beyond the bead section, in order to minimize stress concentration in this region.

[0049] Continuing to refer to Figures 12-13, in certain embodiments, the proximal upper portion 130 includes an upper edge portion 134 having an arcuate contour 140 to minimize stress concentration during tensile loading cycles. For example, in the exemplary embodiment, the arcuate contour 140 includes a first arcuate portion 142 adjacent to the bead 50, a second arcuate portion 144, and a transition portion 146 adjacent to the cuff. The first arcuate portion 142 is positioned close to the second arcuate portion 144, and the second arcuate portion 144 is positioned close to the transition portion 146 with the tissue recovery bag formed (Figures 8-9). The first arcuate portion 142 may have a first radius. The second arcuate portion may have a second radius. In certain embodiments, the first radius is relatively larger than the second radius. In certain embodiments, the first radius is preferably at least about 0.5 inches, more preferably about 0.75 inches. In certain embodiments, the second radius is about 0.25 inches. Preferably, the first arcuate portion having a relatively large radius provides high tensile strength by reducing stress concentration at the attachment tab for the redeployable tissue recovery bag 20 or at the upper edge of the proximal upper portion 130. As the relatively large radius of the first arcuate portion 142 approaches the cuff 124 of the recovery bag 20, the large radius transitions tangentially to the relatively small radius of the second arcuate portion 144, and then tangentially at the transition portion 146 to the vertical edges forming the cuff openings on each side of the recovery bag 20. In this arcuate contour, it is desirable that the first arcuate portion extends beyond the point where the folds forming the cuff begin. Preferably, this configuration makes the smaller radius part of the cuff, which is a stronger section of the bag due to the cuff being formed of two layers of material. As shown in the illustration, on the pouch pattern on which the sheet of material is cut to form a redeployable tissue recovery bag, the arcuate contour 140 of the upper edge 134 with a large radius transitions to a smaller radius and then transitions vertically to form a half-teardrop shape similar to that of a teardrop trailer.

[0050] Continuing to refer to Figures 12-13, the arcuate contour 140 of the upper edge 134 in the exemplary embodiment, which includes a transition from a relatively large radius to a relatively small radius, and then to a vertical edge, advantageously allows the cuff opening to be closer to the bead compared to a configuration having only a large radius. Preferably, by bringing the cuff opening closer to the bead, the cord loop and support arm can be more substantially housed within the cuff.

[0051] As shown in Figure 13, to form the recovery bag, a portion of the cut sheet of material forming the cuff 124 is folded over a pre-tied cord loop and then welded in place to incorporate the cord loop 42 into the cuff 124. The sheet of material is then folded in half lengthwise to form the distal edge of the tissue recovery bag, welded to form the closed end and proximal edge, and cut to form the final shape of the recovery bag. During this second welding step, the lower edge of the proximal upper portion 130 of the recovery bag 20 can also be welded. Thus, the lower edge of the proximal upper portion 130 can have a weld seam that is continuous with the weld seam of the proximal edge, and the lower edge of the proximal upper portion becomes collinear with the proximal edge of the tissue recovery bag. This tissue recovery bag formation process is simple, cost-effective, and results in a tissue recovery bag with high tensile strength. Additional material reinforcement, suturing, or other secondary actions may add cost and complexity to the assembly process and may not be necessary to further improve the tensile load capacity of the redeployable tissue recovery bag. The bead 50 and annular clamp 53 can be attached to the recovery bag 20 using adhesive, heat sealing, ultrasonic welding, or similar processes (Figure 8). In other embodiments, the bead may be formed in two halves to allow for mechanical attachment of the bead to the recovery bag.

[0052] Empirical test data comparing the configuration of a conventional recovery bag 220, as illustrated in Figures 10-11, with the redeployable tissue recovery bag 20 of Figures 8-9, both formed from the same film material, demonstrates the improved strength of the present invention. During tensile testing of the exemplary conventional recovery bag 220, it was observed that the recovery bag 220 fractured at a relatively low average force at the lower radius 232 where the longitudinal upper proximal portion and the downward-extending portion are integrated. During tensile testing of the redeployable tissue recovery bag 20, it was observed that the recovery bag 20 ultimately fractured at a relatively high average force at the arcuate contour 140 of the upper edge 134 of the upper proximal portion 130, indicating that the average tensile strength of the present invention has increased by more than four times compared to the conventional technology.

[0053] Therefore, advantageously, the redeployable tissue recovery bag 20 described herein significantly reduces stress concentration adjacent to the proximal portion of the tissue recovery bag by eliminating the radius 232 and corresponding stress concentration that integrate the proximal portion to which the bead is attached with the proximal edge, among other embodiments. The tissue recovery bag 20 includes an angled upper proximal portion 130 that extends laterally with respect to the central longitudinal axis at the same angle as the proximal edge of the tissue recovery bag 20, so that there is no radius and corresponding stress concentration in this portion of the recovery bag. When the support arm is inserted into the cuff 124 through the bead 50 during device assembly, the upper proximal portion 130 of the tissue recovery bag 20 to which the bead 50 is attached rotates clockwise and folds back due to the flexibility of the recovery bag film material so that it aligns with the cuff. The installed support arm maintains the upper proximal portion 130 of the recovery bag 20 and the attached bead 50 in a state that is longitudinally aligned with the introducer tube (Figure 1).

[0054] In various embodiments, the collection bag 20 can be formed from a pouch pattern die-cut from a sheet of film material. The film material can consist of a variety of materials, including Mylar, polyester, polyethylene, polyimide, polyurethane, ripstop nylon, ripstop polyester, or other similar materials. The film material can also consist of a variety of laminate or coating materials, such as polyurethane coated or laminated ripstop polyester, polyurethane coated or laminated spandex, polyurethane coated or laminated ripstop nylon, polyurethane coated or laminated taffeta, silicone coated ripstop polyester, silicone coated ripstop nylon, or other similar materials. Preferably, the pattern is formed from a material that can be welded or heat-sealed to itself. Ripstop fabrics having a coating or laminate of polymer material can typically be welded or heat-sealed to themselves.

[0055] Referring to Figures 14-15, another embodiment of the redeployable tissue recovery bag 320 is shown. Figure 14 shows a sheet of material that can be formed into the redeployable tissue recovery bag 320. Figure 15 shows a partially formed tissue recovery bag 320 before the beads are bonded. As shown, the tissue recovery bag includes an additional layer 332 of material reinforcement in the upper proximal portion 330 of the recovery bag to increase tensile strength when stretched in a closed configuration. As shown, the tissue recovery bag 320 includes a material reinforcement 332 positioned above the upper proximal portion 330, which is substantially similar in configuration to the upper proximal portion 130 of the redeployable tissue recovery bag 20 in Figures 12-13. In other embodiments, the material reinforcement can be added to the proximal portion of the tissue recovery bag, similar to the exemplary prior art tissue recovery bag shown in Figures 10-11. The additional layer of reinforcing material 332 may preferably be formed from a single sheet of a weldable material such as polyurethane, or in other embodiments, the additional layer may comprise a three-layer laminate including two outer layers of a weldable material such as polyurethane and an inner layer such as ripstop nylon. In the exemplary embodiment, the reinforcing material 332 is welded to each upper proximal portion 330 of the sheet of material forming the tissue recovery bag 320, and then welded together along the seams as the sheet of material is folded and welded to form the recovery bag 320.

[0056] Referring to Figures 16-17, another embodiment of the redeployable tissue recovery bag 420 is shown. Figure 16 shows a sheet of material that can be formed into the redeployable tissue recovery bag 420. Figure 17 shows a partially formed tissue recovery bag 420 before the beads are bonded. In the exemplary embodiment, additional reinforcing material 432 can be formed from the same material as the recovery bag 420. In the case of a recovery bag formed from ripstop nylon and polyurethane laminate material, since the ripstop nylon material is laminated to a polyurethane film, if the peel strength of the seams in the reinforced area should be optimized, the reinforcing material can be welded only to the polyurethane side of the laminate. If the reinforcing material 432 is made from the same material as the recovery bag, it can similarly be welded only to one side. In certain embodiments formed from nylon laminate material, if the reinforcing material 432 is welded to each upper proximal portion 430 of the material sheet cut from the pouch pattern, the ripstop nylon side of the laminate reinforcing material cannot be welded when the material sheet is folded for welding, thus preventing the welding of the pouch pattern in the reinforced area. In exemplary embodiments, to overcome this limitation, the reinforcing material 432 can be advantageously cut to a size that does not cover the seam area of ​​the material sheet along the proximal and lower edges of the upper proximal portion that is welded after the pouch pattern is folded, and welded to the material sheet, allowing the seam portions to be welded together to form a recovery bag. In other embodiments, the reinforcing material 432 can be welded to a recovery bag 420 formed after welding. In these embodiments, the formed recovery bag 420 is turned inside out, and the reinforcing material 432 is welded to the inner upper proximal portion 430 of the recovery bag between the seams to provide a reinforced area.

[0057] Referring to Figures 18-19, another embodiment of the redeployable tissue recovery bag 520 is shown. Figure 18 shows a sheet of material that can be formed into the redeployable tissue recovery bag 520. Figure 19 shows the partially formed tissue recovery bag 520 before the beads are bonded. In the exemplary embodiment, additional reinforcing material 532 may be added along some or all of the upper edges of the upper proximal portion 530. For example, in the exemplary embodiment, the additional reinforcing material 532 is added along the arcuate contours of the upper edges on both sides to reduce stress in this area and further increase the strength of the recovery bag 520. In other embodiments, the reinforcing material 532 may be added only to a portion of the first arcuate portion, the second arcuate portion, and the transition portion of the arcuate portion.

[0058] Certain embodiments of redeployable tissue recovery bags have been described and illustrated herein as having a proximal margin that is transverse to the central longitudinal axis and substantially linear, such that the proximal upper portion extends transversely to the central longitudinal axis and is collinear with the proximal margin. Referring to Figure 20, in other embodiments, the redeployable tissue recovery bag 620 may comprise a proximal upper portion 630 extending transversely to the central longitudinal axis L and a proximal margin 628 having a relatively large radius R and a relatively large arcuate contour that transfers an angular arc Θ. For example, in these embodiments, the upper portion 642 of the proximal margin may be substantially collinear with the upper proximal portion 630 extending transversely to the central longitudinal axis, while the lower portion 644 of the proximal margin may be substantially perpendicular to the closing end 622 of the tissue recovery bag, and the proximal margin 628 has an arcuate contour between the upper and lower portions. In certain embodiments, the proximal margin 628 has an arcuate contour with a radius R of about 4 inches over an angular arc Θ of about 155 degrees. In other embodiments, the radius R or arcuate contour may be larger than 4 inches. In certain other embodiments, the angular arc may be larger than 155 degrees, for example, up to 180 degrees. Preferably, such arrangements can facilitate a relatively large recovery bag volume while maintaining tensile strength in the upper proximal portion and along the proximal margin for redeployable use of the tissue recovery bag.

[0059] Referring to Figures 21–40, specific embodiments of tissue recovery bag assemblies at various stages of manufacturing and assembly are shown. These embodiments of tissue recovery bags can be used with the tissue recovery systems of Figures 1–7. The tissue recovery bag assemblies of Figures 21–40 are configured to be repeatedly redeployable with relatively low stress concentration configurations. Furthermore, the tissue recovery bag assemblies of Figures 21–40 have an elongated profile. These tissue recovery bag assemblies have an open end defined by a cuff and a closed end opposite the open end. The cuff has a proximal end and a distal end that define the longitudinal axis between them and extends along the longitudinal axis of the tubular introducer when the tissue recovery bag is in the storage configuration. The elongated profile of the tissue recovery bag is defined by the portion of the tissue recovery bag that extends distally to the distal end of the cuff. In the exemplary embodiment, the tissue recovery bag extends distally from the distal end of the cuff along a bag axis B that is lateral to the longitudinal axis of the cuff. Advantageously, tissue recovery bags having such a longitudinal contour can have a relatively low pull force for storing the bag in the storage configuration compared to tissue recovery bags having an equivalent volume but without an elongated contour. Furthermore, in certain embodiments, tissue recovery bags having an elongated contour can be wound into an initial storage configuration having a relatively smaller diameter compared to tissue recovery bags of equivalent volume but without an elongated contour. Thus, these embodiments of the tissue recovery system can be particularly suitable for use in tissue recovery systems with relatively small diameters (e.g., 5 mm laparoscopic systems) by enabling a relatively large bag storage volume and a storage configuration with a relatively small diameter. Alternatively, these embodiments of the tissue recovery system can be used in tissue recovery systems with larger diameters (e.g., 10-15 mm laparoscopic systems), providing a tissue recovery bag with a relatively large bag storage volume compared to a tissue recovery system of equivalent diameter but without an elongated contour.

[0060] Referring to Figures 21-22, schematic diagrams of a sheet of material 652 are shown as initially cut, such that they are partially formed into a die-cut pattern (Figure 21) and a recovery bag 650, as further illustrated in Figures 23-24 (Figure 22). To form the recovery bag 650 described herein for use with a redeployable tissue recovery system, a sheet of material 652 can be cut to define an open end 660 having a cuff 662 and a tab or proximal upper portion 670.

[0061] Referring again to Figures 21 and 22, in an exemplary embodiment, the recovery bag 650 includes a proximal upper portion 670 configured to provide an attachment tab for the bead, which provides relatively high tensile strength during the deployment cycle. For example, the proximal upper portion 670 includes a lower edge 672 that is substantially collinear or aligned with the proximal edge of the tissue recovery bag. Thus, the proximal upper portion 670 or the lower edge 672 of the attachment tab is configured to provide relatively high tensile strength with substantially no stress concentration. Since the alignment or collinear arrangement of the lower edge 672 of the upper proximal portion 670 can withstand relatively high tensile forces, in certain embodiments, it is desirable that the upper edge 674 of the upper proximal portion 670 is also configured to minimize stress concentration in the arcuate transition region from the upper proximal portion 670 to the cuff 662 in order to reduce the tendency of the recovery bag 650 to burst. In certain embodiments, the proximal upper portion 670 further comprises an upper edge portion 674 having a relatively large radius on each side that extends slightly beyond the bead section in order to minimize stress concentration in this region.

[0062] Continuing to refer to Figures 21-22, in certain embodiments, the proximal upper portion 670 includes an upper edge portion 674 having an arcuate contour 676 to minimize stress concentration during tensile loading cycles. In certain embodiments, the arcuate contour 676 can be configured as discussed with respect to the tissue recovery bag in Figures 8-9. In other embodiments, the upper portion 670 may include a proximal edge portion having an arcuate contour that transfers an angular arc, as discussed with respect to the tissue recovery bag in Figure 20.

[0063] As shown in Figure 22, to form the recovery bag, a portion of the cut sheet of material forming the cuff 662 is folded over a pre-tied cord loop and then welded in place to confine the cord loop 42 within the cuff 662. In the exemplary embodiment, the recovery bag has an elongated profile with a closed end located distal to the longitudinal axis defined by the cuff 662. In the exemplary embodiment, the cuff 662 is formed as a discontinuous cuff comprising a pair of side segments 665 extending distally along the cuff axis from the proximal end of the cuff 662 and an end segment 667 at the distal end of the cuff. Thus, once the material forming the cuff 662 is formed, each of the side segments 665 and end segments 667 of the cuff 662 is folded over the cord loop 42 and welded in place.

[0064] As shown in Figure 21, the die-cut pattern comprises two notches or recesses 663. Each recess 663 is positioned at the distal end of the side segment 665 of the cuff, such that each recess 663 defines the end of the end segment 667 of the cuff. Each recess 663 may have an arc-shaped edge to reduce stress concentration in the recess.

[0065] Next, the sheet of material is folded in half lengthwise to form the distal edge of the tissue recovery bag (Figure 23), welded to form the closed end and proximal edge, and trimmed to form the final shape of the recovery bag. The folded distal edge extends along the bag axis B, which extends laterally with respect to the longitudinal axis defined by the cuff 662, so that a portion of the tissue recovery bag is positioned distal to the opening defined by the cuff 662. During this second welding step, the lower edge of the proximal upper portion 670 of the recovery bag 20 can also be welded. Thus, the lower edge of the proximal upper portion 670 can have a weld seam that is continuous with the weld seam of the proximal edge, so that the lower edge of the proximal upper portion is collinear with the proximal edge of the tissue recovery bag. This process for forming the tissue recovery bag is simple and cost-effective, resulting in a tissue recovery bag with high tensile strength. Additional material reinforcement, suturing, or other secondary actions may add cost and complexity to the assembly and may not be necessary to further improve the tensile load capacity of the redeployable tissue recovery bag. The bead 50 and annular clamp 53 can be attached to the recovery bag 650 using adhesive, heat sealing, ultrasonic welding, or similar processes (Figure 24). In other embodiments, the bead may be formed in two halves to allow for mechanical attachment of the bead to the recovery bag.

[0066] Referring to Figure 24, in a particular embodiment, the bead 50 may comprise a two-part assembly including a bead body 51 and an annular clamp 53 positioned around a portion of the bead body. A portion of the tissue recovery bag can be positioned between the bead body 51 and the clamp 53 to bond the tissue recovery bag to the bead 50. The recovery bag can be further secured to the bead body and / or clamp by various bonding techniques such as chemical adhesive bonding, ultrasonic welding, heat sealing, or other chemical, thermal, or mechanical bonding processes. 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.

[0067] Referring to Figures 23 and 24, one embodiment of a redeployable tissue recovery bag 650 is shown. Figure 23 shows the tissue recovery bag 650 with the bead 50 removed. Figure 24 shows the tissue recovery bag 650 with the bead 50 joined by an annular clamp 53. In the exemplary embodiment, the tissue recovery bag 650 comprises an open end 660 and a closed end 682 opposite the open end. The cuff 662 extends along the open end 660 and longitudinally from the proximal end to the distal end, defining a cuff axis that extends along the central longitudinal axis L of the introducer when the recovery bag 20 is in the storage position. The cuff 662 is sized and configured to receive the support arm and the cord loop 42. The depth axis D extends perpendicular to the central longitudinal axis L between the open end 660 and the closed end 682. The distal edge of the tissue retrieval bag 650 extends along a bag axis B perpendicular to the longitudinal axis L, such that a portion of the tissue retrieval bag 650 is distal to the open end 660 and the cuff 662.

[0068] Continuing to refer to Figures 23-24, an exemplary embodiment of the tissue recovery bag 650 further includes a distal edge 654 extending from the distal end of the cuff 662 at the open end 660 to the closed end 682. The proximal edge 656 extends from the proximal end of the cuff 662 to the closed end 682. In the exemplary embodiment, the recovery bag 650 is formed from a sheet of material having a fold in the sheet that defines the distal edge 654 and a welded seal that defines the closed end 682 and the proximal edge 656. In other embodiments, the proximal edge may be formed from a folded sheet, and the distal edge may be welded. In yet another embodiment, the tissue recovery bag may be formed from a plurality of sheets bonded or welded together.

[0069] Continuing to refer to Figures 23-24, an exemplary embodiment of the tissue recovery bag 650 further comprises an attachment tab or a proximal upper portion 670. In the exemplary embodiment, the proximal upper portion 670 is located at the open end 660 and extends laterally with respect to the central longitudinal axis L, proximal to the central longitudinal axis L and away from the closed end 682 with respect to the depth axis D. In a particular embodiment, the proximal upper portion is aligned with or extends along an axis that is collinear with the axis defined by the proximal edge portion 656. As shown in Figure 24, the bead 50 is coupled to the proximal upper portion 670.

[0070] Continuing to refer to Figures 23-24, the proximal upper portion 670 comprises a lower edge 672 and an upper edge 674 opposite the lower edge. The lower edge 672 can be aligned with the proximal edge 656 of the tissue recovery bag 650. In the exemplary embodiment, the lower edge 672 is collinear with the proximal edge 656. For example, in a particular embodiment, the lower edge 672 can be formed by a continuity of the weld seam of the proximal edge 656 on the proximal upper portion 670. Advantageously, such alignment or collinear arrangement of the proximal upper portion 670 to which the bead 50 is attached can significantly reduce stress concentrations that may otherwise occur adjacent to the bead 50 in the redeployable tissue recovery bag.

[0071] Referring to Figures 25-30, a particular embodiment of the tissue recovery bag 650 in Figures 21-24 may further include a cuff reinforcement tab 669 (Figure 26) positioned in the cutout 663 of the cuff 662 between the side segment 665 and the end segment 667 of the cuff 662. Referring to Figures 25-28, a schematic diagram of a sheet of material 652 is shown as an initial cut partially formed in the recovery bag 650 as shown in die-cut pattern (Figure 25) and further illustrated in Figures 29-30 (Figures 27-28). Figure 26 shows a schematic diagram of the cuff tab 669, which in the exemplary embodiment is bonded to the sheet of material 652 adjacent to the recess 663 (Figure 27) and folds to define the cuff 662 (Figure 28). To form the recovery bag 650 described herein for use with a redeployable tissue recovery system, a sheet of material 652 can be cut to define an open end 660 having a cuff 662 and a proximal upper portion 670.

[0072] Referring to Figure 26, the cuff tab 669 is shown as a sheet of material cut or formed in a roughly hourglass shape, having a relatively narrow middle section and a relatively wide end section. In certain embodiments, the cuff tab 669 may be formed of the same material and material thickness as the material sheet 652 forming the tissue recovery bag 650. In other embodiments, the cuff tab 669 may be formed of a different material and / or a different thickness than the material sheet 652.

[0073] Referring to Figures 27-28, in the exemplary embodiment, the cuff tab 669 is positioned to cover a recess 663 formed in the material sheet 652 between the side segment 665 and the end segment 667 of the cuff 662. The cuff tab 669 is joined to the material sheet 652 by welding (Figure 27) or the like to form a cuff assembly including the pair of side segments 665, the end segment 667, and the pair of cuff tabs 669. The cuff assembly is then folded to hold the cord loop 42 and joined to the sheet material 652 (Figure 28). The material sheet can then be folded and joined as described for the tissue recovery bag in Figures 23-24.

[0074] Referring to Figures 29-30, embodiments of the tissue retrieval bag 650 are shown, substantially as described with respect to Figures 23-24. The tissue retrieval bag 650 in Figures 29-30 further comprises cuff tabs 669 extending between the distal end of the lateral segment 665 of the cuff 662 and the end of the end segment 667 of the cuff 662. Advantageously, these cuff tabs 669 can reinforce the cuff 662 at their distal ends. This reinforcement increases the tensile strength of the tissue retrieval bag, allowing for greater force to be applied when pulling the bag out of the abdominal wall.

[0075] Referring to Figures 31-34, schematic diagrams of a sheet of material 702 are shown as initial cuts such as a die-cut pattern (Figure 31) and partial formation into a recovery bag 700 (Figure 32), as further shown in Figures 33-34. To form the recovery bag 700 described herein for use with a redeployable tissue recovery system, a sheet of material 702 can be cut to define an open end 710 having a cuff 712 and a proximal end 720.

[0076] Referring to Figures 31-34, a sheet of material 702 can be cut to substantially form a tissue recovery bag, as described with reference to the tissue recovery bag 650 in Figures 21-24. Thus, in the exemplary embodiment, the sheet of material 702 and the tissue recovery bag 700 formed thereby can extend in an elongated profile along the bag axis B between an open end 710 and a closed end 732. The bead 50 can be coupled to the tissue recovery bag 700 in a tab configured to reduce stress concentration and enhance the redeployability of the tissue recovery bag 700. As shown, the tab is defined by a proximal upper portion 720 having a lower edge 722 and an upper edge 724. Unlike the tissue recovery bag 650 in Figures 21-24, the tissue recovery bag 700 includes a cuff 712 having a single recess 713 or cutout defining a pair of side segments 715.

[0077] Continuing to refer to Figures 31-34, the recess 713 is cut into a portion of the sheet of material 702 that is folded to form the cuff 712 (Figure 32). The recess 713 can form a discontinuous cuff defined by two side segments 715. In the exemplary embodiment, the recess 713 is arc-shaped to reduce stress concentration. In other embodiments, a recess 713 of other configurations, such as having a linear cut, can be cut to form a discontinuous cuff 712. The single recess 713 configuration, compared to the double recess 663 configuration (Figures 21-24), has less material at the distal end of the cuff, and since this is usually the most difficult part to store the tissue recovery bag in the introducer tube, the force pulling the tissue recovery bag 700 into the introducer tube can be reduced.

[0078] Referring to Figures 31-34, in one method for forming the tissue recovery bag 700, the side segment 715 of the cuff 712 can be folded to hold the cord loop 42 and joined to a sheet of material 702. The sheet of material 702 can be folded to define a folded edge 704 that extends along the bag axis B, which is lateral to the axis defined by the cuff. Both edges can be joined by welding or the like to define the sealed edge 706 of the tissue recovery bag. The bead 50 can be joined to a tab on the proximal upper portion of the bag 720.

[0079] Referring to Figures 35–40, a particular embodiment of the tissue recovery bag 700 in Figures 31–34 may further include cuff reinforcement, such as a cuff ring 719 (Figure 36) positioned in a recess 713 of the cuff 712 between the side segments 715 of the cuff 712. Referring to Figures 35–38, a schematic diagram of a sheet of material 702 is shown as an initial cut, such as a die-cut pattern (Figure 35) and partially formed into the recovery bag 700 as further shown in Figures 39–40 (Figures 37–38). Figure 36 shows a schematic diagram of the cuff ring 719, which in the exemplary embodiment is joined to the sheet of material 702 adjacent to the recess 713 (Figure 37) and folds to define the cuff 712 (Figure 38). To form the recovery bag 700 described herein for use with a redeployable tissue recovery system, a sheet of material 712 can be cut to define an open end 710 having a cuff 712 and a proximal upper portion 720.

[0080] Referring to Figure 36, the cuff ring 719 is shown as a sheet of material cut or formed into a substantially annular or ring shape, having recesses or notches formed in the ring-shaped segments. In the exemplary embodiment, the cuff ring 719 has a radius that is approximately corresponding to the radius of the recess 713 of the cuff 712, so that the cuff ring 719 can be positioned adjacent to the recess 713. In certain embodiments, the cuff ring 719 may be formed of the same material and material thickness as the material sheet 702 forming the tissue recovery bag 700. In other embodiments, the cuff ring 719 may be formed of a different material and / or a different thickness than the material sheet 702.

[0081] Referring to Figures 37-38, in the exemplary embodiment, the cuff ring 719 is positioned adjacent to a recess 713 formed in the material sheet 702 between the side segments 715 of the cuff 712. The cuff ring 719 is joined to the sheet material 702 by welding (Figure 37) or the like to form a cuff assembly comprising the pair of side segments 715 and the cuff ring 719. The cuff assembly is then folded to hold the cord loop 42 and joined to the sheet material 702 (Figure 38). The sheet of material can then be folded and joined, as described with respect to the tissue recovery bag in Figures 23-24.

[0082] Referring to Figures 39-40, embodiments of the tissue retrieval bag 700 are shown, substantially as described with respect to Figures 23-24. The tissue retrieval bag 700 of Figures 39-40 further comprises a cuff ring 719 extending between the distal ends of the lateral segments 715 of the cuff 712. Advantageously, the cuff ring 719 can reinforce the cuff 712 at its distal end. This reinforcement increases the tensile strength of the tissue retrieval bag, allowing for greater force to be applied when pulling the bag out of the abdominal wall.

[0083] Referring to Figures 41-42, one embodiment of the tissue recovery bag is shown. In the exemplary embodiment, the tissue recovery bag 20 in Figures 8-9 and 12-13 is further reinforced by circular reinforcing tabs or reinforcing discs 150 bonded to the sheet of material 18. In the exemplary embodiment, the reinforcing disc 150 is positioned on the material sheet 18 adjacent to the arcuate upper edge 134 of the proximal upper portion 130, preferably adjacent to a potential stress concentration area of ​​the tissue recovery bag 20, providing additional strength. In the exemplary embodiment, two reinforcing discs 150 are bonded to the sheet of material, and each reinforcing disc 150 is positioned adjacent to the upper edge 134 of each side edge of the sheet of material 18 such that the reinforcing discs 150 overlap each other when the sheet of material is folded (Figure 41) to form the tissue recovery bag 20. In other embodiments, a single reinforcing disc can be used, positioned adjacent to the upper edge on one side of the sheet material 18.

[0084] Continuing to refer to Figures 41 and 42, in certain embodiments, each reinforcing disc 150 comprises a substantially circular portion of the material sheet. In various embodiments, the reinforcing disc 150 may include the same material and material thickness as the material sheet 18. In other embodiments, the reinforcing disc may include a different material and / or a different material thickness than the material sheet 18 forming the tissue recovery bag 20.

[0085] Continuing to refer to Figures 41-42, the exemplary embodiment of the tissue recovery bag 20 having the reinforcing disc 150 can advantageously increase the strength of the bag during the removal of the closed bag for a redeployable system. Preferably, a circular reinforcing feature such as the reinforcing disc 150 can simplify the placement and welding during manufacturing compared to reinforcing features having more complex shapes, thus facilitating the manufacture of the tissue recovery bag 20. Furthermore, unlike other specific reinforcing shapes, the same reinforcing disc 150 component can be used on either the left or right side of the sheet of material in the tissue recovery bag pattern, regardless of whether the material is weldable on one side or both sides. Thus, while weldable materials on both sides, such as polyurethane, ripstop nylon, and polyurethane laminates, may be preferred for tissue recovery bag configurations with reinforcing features having distinct left- and right-side reinforcing shapes, such material selection considerations would not apply to the exemplary circular reinforcing disc 150.

[0086] While specific embodiments of redeployable tissue recovery bags have been described herein, modifications and further combinations of these embodiments of tissue recovery bags are intended to be made in further embodiments of tissue recovery bags within the scope of this application. For example, in certain further embodiments, any of the various reinforcements to the upper proximal portion of the tissue recovery bag described with respect to Figures 14-19 and 41-42 can be added to the embodiment of the tissue recovery bag having an elongated contour described with respect to Figures 21-40. Furthermore, in yet another embodiment of the tissue recovery bag advantageously configured for redeployable operation, certain additional embodiments described below can be incorporated into the embodiments herein.

[0087] In certain embodiments, the upper proximal portion of the recovery bag may include an edge having a radius increased to a relatively large size to reduce stress in this region.

[0088] In various embodiments, after the bead is attached to the recovery bag, the upper proximal portion of the bead and the recovery bag can be rotated around the central longitudinal axis relative to the cuff and open end of the bag during the assembly of the bead. In one embodiment, the bead and the upper proximal portion can be rotated by 180 degrees. In other embodiments, the bead and the upper proximal portion can be rotated by an angle of less than 180 degrees. In a particular embodiment, the bead and the upper proximal portion are rotated by at least 90 degrees around the central longitudinal axis relative to the cuff and open end of the bag. During the initial assembly of the tissue recovery system, a support arm is inserted into the cuff of the recovery bag through the rotated bead to maintain the bead and the upper proximal portion in this orientation. This rotation creates a twist in the upper proximal portion, which can reduce stress on the upper radius, resulting in a recovery bag with improved strength in this portion.

[0089] In various embodiments, the bead and annular clamp may be sized and configured with an elongated profile to allow assembly of a recovery bag having a lower radius in the upper proximal portion, with the lower radius completely enclosed within the bead and annular clamp. Such enclosed positioning can preferably reduce the effects of stress concentration in the lower radius and improve strength in this region.

[0090] While this application discloses certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention, as well as obvious modifications and equivalents thereof. Furthermore, various features of these inventions can be used alone or in combination with other features of these inventions not expressly described above. Accordingly, the scope of the invention disclosed herein is not to be limited to the specific disclosed embodiments described above, but is to be determined solely by a fair interpretation of the appended claims.

Claims

1. It is an organizational recovery system, A tubular introducer having a proximal end and a distal end, with a central longitudinal axis defined between the proximal end and the distal end, the tubular introducer having a lumen extending between the proximal end and the distal end, An actuator that is slidable longitudinally within the lumen of the introducer and has a proximal end and a distal end, A pair of support arms extending distally from the distal end of the actuator along the central longitudinal axis, A tissue recovery bag, removably attached to the support arm, having an open end and a closed end opposite the open end, Equipped with, The aforementioned tissue collection bag is A cuff extending longitudinally at the open end between the proximal end and the distal end of the open end, the cuff configured to receive the pair of support arms, An upper proximal portion is located at the proximal end of the cuff, extending in a direction lateral to the longitudinal axis, close to the longitudinal direction and away from the closed end, Includes, The aforementioned tissue recovery system further, The bead is connected to the upper proximal portion and configured to slidably receive a pair of support arms, Tissue recovery system.

2. The tissue recovery system according to claim 1, wherein the tissue recovery bag has a distal edge portion at the distal end of the cuff that extends from the open end to the closed end.

3. The tissue recovery system according to claim 2, wherein the distal edge includes a folded edge.

4. The tissue recovery system according to claim 1, wherein the tissue recovery bag has a proximal edge portion at the proximal end of the cuff that extends from the open end to the closed end.

5. The tissue recovery system according to claim 4, wherein the proximal edge portion comprises a weld seam.

6. The tissue recovery system according to claim 5, wherein the upper proximal portion comprises an upper edge and a lower edge opposite to the upper edge.

7. The tissue recovery system according to claim 6, wherein the lower edge is collinear with the proximal edge.

8. The tissue recovery system according to claim 6, wherein the upper edge portion has an arc-shaped contour.

9. The tissue recovery system according to claim 8, wherein the arc-shaped contour comprises a first arc-shaped portion having a first radius, a second arc-shaped portion having a second radius, and a transition contour.

10. The tissue recovery system according to claim 9, wherein the first radius is larger than the second radius.

11. The tissue recovery system according to claim 1, wherein the tissue recovery bag is operable between a storage position in which the tissue recovery bag is positioned within the introducer and a first deployed position in which the tissue recovery bag is unfolded from the introducer and coupled to the support arm, and longitudinal movement of the actuator within the lumen causes the tissue recovery bag to repeatedly operate between an open configuration and a closed configuration.

12. It is an organizational recovery system, A tubular introducer having a proximal end and a distal end, with a central longitudinal axis defined between the proximal end and the distal end, the tubular introducer having a lumen extending between the proximal end and the distal end, An actuator that is slidable longitudinally within the lumen of the introducer and has a proximal end and a distal end, A pair of support arms extending distally from the distal end of the actuator along the central longitudinal axis, A tissue recovery bag removably coupled to the support arm, having an open end and a closed end opposite the open end, with a depth axis defined that extends perpendicular to the central longitudinal axis from the open end to the closed end, and the open end extending along the central longitudinal axis from the proximal end to the distal end, The aforementioned tissue collection bag is The distal edge portion extending from the distal end of the open end to the closed end, A proximal edge portion extending from the proximal end of the open end to the closed end, comprising a proximal edge portion extending laterally with respect to the central longitudinal axis, An upper proximal portion is positioned at the proximal end of the open end and extends collinearly with the proximal edge portion, away from the closed end with respect to the depth axis, Includes, The aforementioned tissue recovery system further, The bead is connected to the upper proximal portion and configured to slidably receive a pair of support arms, Tissue recovery system.

13. The tissue recovery system according to claim 12, wherein the tissue recovery bag is formed from a sheet of material.

14. The tissue recovery system according to claim 13, wherein the proximal edge portion comprises a weld seam.

15. The tissue recovery system according to claim 14, wherein the upper proximal portion comprises an upper edge and a lower edge opposite to the upper edge.

16. The tissue recovery system according to claim 15, wherein the lower edge portion comprises a weld seam that is collinear with the proximal edge portion.

17. The tissue recovery system according to claim 15, wherein the upper edge portion has an arc-shaped contour.

18. A tissue recovery bag for use in a redeployable tissue recovery system, An open end, the open end extending along the central longitudinal axis from the proximal end to the distal end of the open end, A closed end opposite to the open end, the closed end having a depth axis that extends from the open end to the closed end perpendicular to the central longitudinal axis, The distal edge portion extending from the distal end of the open end to the closed end, A proximal edge portion extending from the proximal end of the open end to the closed end, comprising a proximal edge portion extending laterally with respect to the central longitudinal axis, A mounting tab positioned at the proximal end of the open end and extending collinearly with the proximal end, away from the closed end with respect to the depth axis, The bead coupled to the aforementioned mounting tab, A tissue recovery bag equipped with [a specific feature / equipment].

19. The tissue recovery bag according to claim 18, wherein the mounting tab comprises a lower edge and an upper edge.

20. The tissue recovery bag according to claim 19, wherein the lower edge is collinear with the proximal edge.

21. The tissue recovery bag according to claim 19, wherein the upper edge portion has an arc-shaped contour.

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