Patent ID: 12193693

DETAILED DESCRIPTION OF THE INVENTION

With reference toFIGS.1A and1B, an embodiment of tissue retrieval system10is illustrated. The illustrated tissue retrieval system can be used for containing and withdrawing excised tissue specimens from within a body cavity. Certain aspects of tissue retrieval systems are described in U.S. Pat. No. 8,721,658, entitled “TISSUE RETRIEVAL SYSTEM,” and U.S. Pat. No. 9,033,995, entitled “SINGLE INCISION LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM.” Each of these patents is incorporated by reference herein in its entirety.

In various embodiments, tissue retrieval systems10described herein provide a versatile redeployable retrieval system that can be used for serially containing and withdrawing multiple small tissue specimens during a surgical procedure without removing the retrieval bag from the device while also enabling the extraction of a large tissue specimen by cinching the retrieval bag and then detaching the retrieval bag from the introducer. In some procedures, the surgeon may only need the ability to serially contain and withdraw small specimens from the patient. In some procedures, the surgeon may need the ability to serially contain and withdraw multiple small tissue specimens and may then also need to contain and extract a large specimen. In other procedures, the surgeon may only need to contain and extract a large tissue specimen. As the retrieval systems described herein meet many different surgical requirements, a hospital or surgery center using these systems may be able to limit the number of retrieval system models to stock for its surgical needs.

The illustrated tissue retrieval system can desirably be used in certain procedures for serially containing and withdrawing multiple excised small tissue specimens. Advantageously, certain embodiments of tissue retrieval system described herein can permit the use of a single retrieval system for the serial removal of multiple lymph nodes during a procedure.

With reference toFIGS.1A and1B, in certain embodiments, a tissue retrieval system10includes a retrieval bag20at its distal end, which provides a receptacle for tissue specimens. The retrieval bag20can have an open end and a closed end opposite the open end. The retrieval bag20can further comprise a cuff21formed at the open end for receiving a pair of support arms40to suspend the retrieval bag20and a cord loop to selectively cinch the open end of the retrieval bag. In various embodiments, the retrieval bag can be formed of a ripstop nylon and polyurethane laminate, polyurethane, or a combination of both materials. For example, the retrieval bag can be formed from a ripstop nylon and polyurethane laminate and can include a polyurethane reinforcement at the tip of the retrieval bag to increase the burst strength and puncture resistance of the retrieval bag. The reinforcement can be comprised of a ripstop nylon or a ripstop nylon and polyurethane laminate. As an alternative to the ripstop nylon and polyurethane laminate, the ripstop nylon can be coated with polyurethane.

In a procedure to retrieve multiple small specimens, after insertion of a tissue specimen into the retrieval bag, the retrieval bag20can be reversibly closed to prevent spillage of its contents and to prevent contamination of the body cavity and body cavity wall during withdrawal of the retrieval bag20from within the body cavity. Once the retrieval bag is withdrawn from the body cavity, the retrieval bag is reopened, the tissue specimen can be removed, labeled, and then forwarded to a pathologist for analysis. The retrieval bag can then be fully retracted into the introducer tube and redeployed within the patient for subsequent containment and withdrawal of the next targeted tissue specimen.

The tissue retrieval system10can also be used in procedures for removing large tissue specimens, such as a gallbladder or kidney, from within a body cavity. In these procedures, the retrieval bag20can be fully cinched closed and detached from the system for subsequent withdrawal of the retrieval bag20through the body wall. In some procedures, such as those related to the excision of cancerous tissue, it may be desirable to first serially remove small tissue specimens, such as lymph nodes, and to then remove the larger tissue specimen. In this case, the tissue retrieval system10enables the retrieval bag to be reversibly closed for serially removing smaller tissue specimens and enables the retrieval bag to be fully cinched closed and detached for removal of the large tissue specimen.

With reference toFIGS.1A-6A, certain embodiments of tissue retrieval system10are illustrated in various configurations for use in procedures to retrieve multiple tissue specimens in a single procedure. With reference toFIGS.1A and1B, the tissue retrieval system10is illustrated in a first deployed condition. In the illustrated embodiment, the tissue retrieval system has an introducer3and an actuator7or actuation rod. The introducer3in one aspect has a tubular configuration with a hollow lumen and a handle assembly5extending from a proximal end of the introducer3. In some embodiments, the introducer3can be sized and configured for placement through a standard-size trocar. For example, it can be desirable that the introducer3can be sized as a 5 mm laparoscopic surgical instrument to be introduced through relatively small diameter trocars such as 5-7 mm trocars. In other embodiments, the introducer3can be sized as a 10 mm or a 12 mm laparoscopic surgical instrument. In some embodiments, the introducer3can have a non-standard size for application at a specific location. In some embodiments, the tissue retrieval system10can include a relatively long introducer, such as, for example, a 45 cm long introducer3to improve access to the surgical site.

The handle assembly5of the illustrated embodiment can comprise a compact handle member that can be adapted for placement adjacent other surgical instruments in a single port laparoscopic surgical site. Thus, in some embodiments, the tissue retrieval system is adapted to be utilized during single incision laparoscopic procedures. In other embodiments, the handle assembly can include a pair of finger loops or grips formed with or otherwise coupled to the handle assembly5that can be utilized to hold or stabilize the introducer3as desired.

In the illustrated embodiment of tissue retrieval system10, the introducer3has a proximal end and a distal end that are generally open, which can facilitate access to the hollow lumen. As illustrated, the actuator7extends into the hollow lumen from the open proximal end thereof, and at least a portion of the actuator7is slidably movable within the hollow lumen of the introducer3. With reference toFIG.2, the actuator rod can be withdrawn to a proximal position for insertion to a surgical site through an access port such as a trocar. With the actuator7in the proximal position the tissue retrieval bag20is in a stowed configuration positioned in the hollow lumen of the introducer3. The actuator7in one aspect has a handle such as a thumb loop extending from a proximal end thereof. The handle provides a graspable portion of the device to control or facilitate movement of the actuator7relative to the introducer3between the proximal position (illustrated inFIG.2), and a first deployed condition of the tissue retrieval system (illustrated inFIG.1A).

With reference toFIGS.3-6Aexemplary methods for using the illustrated embodiment of tissue retrieval system10to retrieve tissue specimens at a surgical site are illustrated. In certain embodiments, the tissue retrieval system can be provided in either a stowed configuration (FIG.2) or a first deployed configuration (FIG.1A). In some embodiments, it can be desirable that the tissue retrieval system10is packaged with the retrieval bag20deployed out of the distal end of the introducer tube to ensure that the retrieval bag20maintains its original configuration and easily unfurls during surgical use. During clinical use, an access device such as a trocar100comprising a trocar cannula and trocar seal housing is first placed through a body wall W leaving the trocar cannula disposed across the body wall W. If the tissue retrieval system10was provided in a first deployed configuration, a nurse or surgeon configures the tissue retrieval system to a stowed configuration (FIG.2) by fully retracting the retrieval bag20within the introducer3tube by withdrawing the actuator7in a proximal direction to position the actuator rod in a proximal position. The tissue retrieval system10can then be inserted into the trocar seal housing and trocar cannula until the distal end of the introducer3tube extends beyond the distal end of the trocar cannula. The retrieval bag20is then deployed from within the introducer3tube and into the body cavity by advancing the actuator in a distal direction to the first deployed position (FIG.3).

With continued reference toFIG.3, once extended into the body cavity, the retrieval bag20in the first deployed configuration is suspended and held open by two support arms40that extend into a cuff at the open end of the retrieval bag. In the illustrated embodiment, the retrieval bag includes a bead50attached to a proximal portion of the cuff through which the support arms40extend. In the first deployed position, the illustrated embodiment of tissue retrieval system comprises a retaining latch coupled to a distal end of the actuator7and engaged with the bead50. Advantageously, the retaining latch enables the surgeon to selectively control a release of the retrieval bag20from the support arms and the actuator. While in the first deployed position, the retaining latch is engaged with the bead50to prevent the release of the retrieval bag20relative to the support arms, the retaining latch is releasably attached to the bead50. When engaged with the bead50, the retaining latch enables the retrieval bag20to be completely retracted into the introducer3(FIG.2) with the actuator7withdrawn to a proximal position for subsequent insertion through the trocar. When engaged with the bead50, the retaining latch also enables the retrieval bag20to be partially retracted into the introducer tube (FIG.4) to a redeployable cinched configuration, allowing reversible closing of the opening of the retrieval bag. Thus sequential, repeated opening and closing of the tissue retrieval bag20can be used to contain multiple small tissue specimens in a single procedure for subsequent withdrawal from the patient achieved by repeatedly advancing the actuator to a first deployed position (FIG.3) and withdrawing the actuator towards the proximal position (FIG.4) to position the tissue retrieval bag in a redeployable cinched configuration.

With reference toFIG.4, once a small tissue specimen has been positioned in the retrieval bag, partial retraction and closure of the retrieval bag20is achieved by retracting the actuator7into the introducer3tube until the support arms40and the cuff are drawn into the introducer3tube, leaving a distal portion of the retrieval bag20with contained tissue outside of the introducer3tube. Various techniques can then be used to remove the tissue specimen from the surgical site across the body wall. For example, the tissue retrieval system10can be withdrawn through the trocar, leaving the trocar disposed across the body wall, or the tissue retrieval system can be directly withdrawn through the body wall after withdrawal of the trocar from the patient. For very small tissue specimens, the entire retrieval bag20with the contained specimen can be withdrawn into the introducer tube. In this case, the tissue retrieval system can be withdrawn through the trocar, leaving the trocar disposed across the body wall.

Once the tissue retrieval system10has been withdrawn from the surgical site, the actuator7can be advanced distally to the first deployed position (FIG.1A) and the tissue specimen removed for analysis. If further small tissue specimens are desired to be obtained, the actuator7can then be withdrawn to the proximal position (FIG.2) for reintroduction to the surgical site as described above. As further described below with reference toFIGS.16-28and56-58, in certain embodiments, the tissue retrieval system can include stop mechanisms to limit travel of the actuator between the proximal position and the first deployed position until it is desired to separate the tissue retrieval bag20from the actuator7. Advantageously, these stop mechanisms can reduce the potential for an inadvertent full deployment of the tissue retrieval bag before all of the desired tissue specimens have been collected for analysis.

The tissue retrieval system10can also be used to in procedures to extract relatively large tissue specimens such as a gallbladder, appendix, or kidney. In these procedures, desirably with the tissue retrieval bag in the first deployed configuration (FIG.3) during placement of a large tissue specimen such as the gallbladder, the retaining latch prevents inadvertent movement of the retrieval bag relative to the support arms and the actuator. Once a large specimen has been positioned in the tissue retrieval bag, it is desirable to cinch and fully detach the retrieval bag from the introducer, leaving the cinched retrieval bag within the body cavity. If the procedure requires the serial removal of small tissue specimens such as lymph nodes and then requires the removal of a large tissue specimen, the cinching and detachment of the retrieval bag would be completed after the serial removal of the smaller tissue specimens. Once the retrieval bag is cinched closed and detached from the introducer, the surgeon then removes the trocar from the body wall and can then extract the retrieval bag through the body wall.

In certain embodiments, the tissue retrieval system10can be selectively actuated from the first deployed configuration (FIG.3) to position the actuator and tissue retrieval bag in a fully deployed configuration (FIG.5). Once a 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 within the retrieval bag, the surgeon actuates a deployment release mechanism for example by pressing a deployment release button on the handle assembly. With actuation of the deployment release mechanism, the actuator can be advanced distally beyond the first deployed position to a second or fully deployed position (FIG.5). Advancement of the actuator to its fully deployed position causes the bead and the distal end of the retaining latch to be disposed out of the distal end of the introducer tube.

With reference toFIGS.5and6A, in certain embodiments, the tissue retrieval system10can include a stop mechanism to prevent reintroduction of the bead into the distal end of the introducer3once the actuator7has been advanced to the fully deployed position. For example, in the illustrated embodiment, the tissue retrieval system10comprises a bead stop60, which is positioned between the actuator7and the bead50. As further discussed below with reference toFIGS.10-15, with the actuator in the fully deployed position, the bead stop is also advanced to its most distal position where it lockingly engages the introducer to obstruct the distal end of the introducer3. This obstruction prevents the bead and the retrieval bag, once fully deployed, from being withdrawn into the introducer tube. This obstruction also presents a bearing surface such that subsequent proximal withdrawal of the actuator from the fully deployed position withdraws the support arms from the cuff of the tissue retrieval bag20and cinches the tissue retrieval bag20(FIG.6A). Once the retrieval bag is cinched closed, a small loop of the cord loop42is exposed near the proximal end of the introducer3tube.

In certain embodiments, the tissue retrieval system comprises a cord loop positioned to selectively cinch the opening of the tissue retrieval bag into a closed configuration. The cord loop can extend through the cuff at the open end of the tissue retrieval bag20and extend proximally into the introducer along a receiving channel in the actuator. The cord loop can be removably coupled to the actuator. In certain embodiments, the cord loop is dimensioned such that its proximal end is positioned between the proximal end and the distal end of the actuator and retained by the actuator. Desirably, in certain embodiments, the cord loop is dimensioned such that its length enables cinching of the retrieval bag and exposure of the cord loop on the actuator after cinching. When the retrieval bag is cinched closed, the cord loop is fully tensioned. Prior to full tensioning of the cord loop during cinching of the retrieval bag, the cord loop is fully contained within the introducer tube of the retrieval system. In certain embodiments, the cord loop is not exposed during deployment of the retrieval bag or during retraction of the retrieval bag within the introducer tube. For example, during insertion to the surgical site and serial containment and withdrawal of multiple small tissue specimens (FIGS.2-4), the cord loop is not exposed. In these embodiments, the cord loop42is only exposed to the surgeon when the cord loop is fully tensioned and the retrieval bag is cinched closed (FIG.6A). This feature prevents the surgeon from unintentionally grasping, cutting, releasing, or tensioning the cord loop during use of the device. The cord loop can be stored in the introducer tube in a non-tensioned condition with a portion of the cord loop being folded and stored in a receiving channel on the underside of the actuator.

The cord loop42can provide an ergonomic and high strength means for grasping and withdrawing the retrieval bag through the abdominal wall. As the cord is formed of a single loop of cord, there is no limitation in terms of being able to manually grip the cord loop. The cord loop also provides a robust means for withdrawing the retrieval bag through the body wall as two strands of the cord absorb the tension being applied by the surgeon. For example, if the surgeon is applying a tensile force of 20 lbs. to the cord loop during withdrawal of the retrieval bag, each strand of the cord is being tensioned at a force of 10 lbs. Certain other retrieval systems have included relatively small loops of material which can make it difficult to manually grasp the loop. Other retrieval systems have also included a small loop that is connected to a single strand of cord or line where a 20 lb. tensile force applied by the surgeon results in a 20 lb. tensile force being applied to the cord. In some cases, the single strand of cord or line of these other retrieval systems can fail during withdrawal of the retrieval bag.

Another advantage provided by the cord loop is that the cord loop is relatively short after cinching of the retrieval bag, providing for easier management of the cord and easier withdrawal of the retrieval bag through the body wall. In certain embodiments of tissue retrieval systems described herein, the length of the cord loop with the retrieval bag cinched is about 14″. Other retrieval systems can have a cord with a length greater than about 25″ after cinching of the retrieval bag making the cord unwieldy and difficult to manage and use during withdrawal of the retrieval bag through the body wall.

With reference toFIG.6A-6C, once the tissue retrieval bag20has been cinched, there are at least two techniques for withdrawal of the cinched retrieval bag from within the body cavity. For the first method, the retrieval bag can be completely detached and removed from the actuator and introducer tube by lifting the cord loop42from the retaining slot on the actuator.FIG.6Bis a detail view of a cord loop coupled to the actuator once the tissue retrieval bag has been cinched. InFIG.6B, the cord loop42comprises a single continuous loop.FIG.6Cillustrates a detail view of another embodiment of cord loop43that can be used in various embodiments of tissue retrieval systems described herein. In the illustrated embodiment, the cord loop43can comprise a grasping loop45at a proximal end thereof adjacent the retaining slot on the actuator. Advantageously, the grasping loop45can facilitate grasping of the cord loop43once the tissue retrieval bag has been cinched. In certain embodiments, the grasping loop45can be coupled to the cord loop43at a low profile interface such as by ultrasonic welding, bonding, heat sealing or fusing together. Such a low profile interface can desirably facilitate assembly of the cord loop with the actuator in the tissue retrieval system as the cord loop may be routed to pass through one or more sealing O-rings or other constrictions within the introducer, which may impede the passage of a knot or other higher profile coupling.

With reference toFIG.6A, once the cord loop has been decoupled from the actuator, the device and the trocar seal and cannula can then be withdrawn from the body wall leaving the retrieval bag20in the body cavity and the cord loop42disposed across the body wall. The neck of the retrieval bag can then be withdrawn through the body wall using the bead as a dilator to aid with movement of the retrieval bag through the layers of tissue fibers in the body wall. Once the neck of the retrieval bag has traversed the body wall, the retrieval bag can then be reopened by manually grasping the closed end of the retrieval bag and the bead and sliding the bead along the cord. The retrieval bag can then be accessed to remove or compact its contents to aid with complete withdrawal from the body cavity using standard open and laparoscopic instrumentation such as forceps, graspers, and aspiration probes. Once the bulk of the contents are removed, the retrieval bag can then be closed by manually grasping the open end of the retrieval bag and the bead and sliding the bead along the cord. The cord loop can then be grasped manually and the retrieval bag then completely withdrawn from the body cavity. In some procedures, the surgeon may withdraw the retrieval bag through the body wall without reopening the retrieval bag.

A second method for withdrawal of the retrieval bag20from within the body cavity can be used for smaller tissue specimens, such as a small gallbladder, placed in the retrieval bag which are not likely to need to be aspirated, compacted, or removed from the retrieval bag prior to withdrawal of the retrieval bag 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 and through the body wall.

With reference toFIGS.7-9, certain components of the tissue retrieval systems described herein that contribute to the redeployable operation of these systems are illustrated. The operation of these components at a distal end of an introducer in an embodiment of tissue retrieval system is illustrated in the first deployed position inFIGS.10and11and in a second deployed position inFIGS.12-15.FIG.7illustrates an embodiment of bead for use with various embodiments of tissue retrieval system.FIG.8illustrates an embodiment of retention latch for use with various embodiments of tissue retrieval system.FIG.9illustrates an embodiment of bead stop for use with various embodiments of tissue retrieval system.

With reference toFIG.7, an embodiment of bead50for a tissue retrieval system is illustrated. As illustrated, the bead50comprises a pair of channels52through which the support arms can slide. The bead50can further comprise a hole54through which the cord loop runs that frictionally engages the cord loop to enable the retrieval bag to be cinched closed and reopened as needed once the retrieval bag has been completely detached from the actuator and the introducer. The bead can also be configured to releasably engage the retaining latch. In the illustrated embodiment, the bead50includes a recess56and a ledge57positioned in the recess to engage a distal end of the retaining latch. In certain embodiments, the bead50is injection molded from polycarbonate, and, in other embodiments, the bead50can be formed from other materials such as nylon, ABS, and polyester.

With continued reference toFIG.7, in certain embodiments, the bead54is configured to facilitate withdrawal of the cinched retrieval bag through the body wall. In certain embodiments a proximal end of the bead54can comprise a blunt, tapered, or radiused surface58to facilitate withdrawal of the bead through a body wall. Thus, the bead can dilate muscle and tissue fibers of the body wall during withdrawal of the retrieval bag. Advantageously, as the bead traverses the body wall, the cinched cuff and the remainder of the retrieval bag can easily follow. Retrieval systems that do not include a bead can require the bunched cuff of the cinched retrieval bag to be pulled directly into the body wall where the bunched cuff can sometimes catch on the body wall resulting in an increase in the extraction force during withdrawal of the retrieval bag.

With continued reference toFIG.7, the illustrated embodiment of bead50includes a passage, bore, or hole54through which the cord loop runs that frictionally engages the cord loop to enable the retrieval bag to be cinched closed and reopened as needed once the retrieval bag has been detached from the introducer. Thus, during withdrawal of the retrieval bag from the body cavity, once the neck of the retrieval bag has traversed the body wall, the retrieval bag can advantageously be easily reopened to enable access to remove or compact its contents. Previous retrieval bags with no bead can be very difficult or impossible to reopen once the retrieval bag has been cinched closed.

With continued reference toFIG.7, in certain embodiments the bead50can comprise a two-piece assembly comprising a bead body51and an annular clamp53positioned around a portion of the bead body (FIG.11). A portion of the tissue retrieval bag can be positioned between the bead body51and the clamp53to couple the tissue retrieval bag to the bead50. Various joining techniques such as gluing with chemical adhesives, ultrasonic welding, heat sealing, or other chemical, thermal, or mechanical joining processes can further secure the retrieval bag to the bead body and/or clamp. In other embodiments, the bead can be a single component without an encircling clamp, and the single component bead can be coupled to the retrieval bag with various chemical, thermal, or mechanical joining processes.

With reference toFIG.8, an embodiment of retaining latch70for use in various embodiments of tissue retrieval system is illustrated. The illustrated retaining latch70comprises an actuator cap configured to be positioned at the distal end of the actuator. Thus, the retaining latch70can comprise a proximal portion72coupled with the distal end of the actuator. The retaining latch comprises a latch arm74extending distally from the proximal portion72. The latch arm74can be configured to releasably engage the bead. For example, in the illustrated embodiment, the latch arm74comprises a latch tab76at the distal end thereof. In the illustrated embodiment, the latch tab76extends radially inwardly to releasably engage the ledge57of the bead50(FIG.7). In certain embodiments, the actuator cap with the integral retaining latch is injection molded from polycarbonate, and, in other embodiments can be formed from other materials such as nylon, acrylonitrile butadiene styrene (ABS), polyester, polypropylene, stainless steel, spring steel, titanium, or nitinol.

While in the illustrated embodiment, the actuator cap comprises a single retaining latch engageable with a corresponding ledge on the bead, it is contemplated that in other embodiments the actuator cap includes two retaining latches engageable with the bead, and the bead comprises a corresponding two ledges. Moreover, while the actuator cap and retaining latch are illustrated as a single component, it is contemplated that in other embodiments, the actuator cap is formed of two components where the body of the actuator cap is formed of a polymer material such as polycarbonate, ABS, nylon, or polypropylene, and the retaining latch is formed of a metal material such as stainless steel, spring steel, titanium, or nitinol. In certain embodiments, the metal retaining latch can be overmolded during molding of the actuator cap, bonded to the actuator cap, heat staked to the actuator cap, snap fitted to the actuator cap, mechanically trapped between the actuator cap and the introducer tube, or mechanically trapped between the actuator cap and the actuator. The metal retaining latch can be biased to spring to a decoupled position upon advancement of the actuator to its fully deployed position. The separate retaining latch can include a spring or an integral spring element to bias the latch to a decoupled position relative to the ledge on the bead.

With reference toFIG.9, an embodiment of bead stop60for use in various embodiments of tissue retrieval system is illustrated. In the illustrated embodiment, the bead stop60comprises a body portion62and a locking arm64. As illustrated, the locking arm64is integrally formed with the body portion62and is formed as a cantilever spring arm. The locking arm64can comprise a tab configured to engage the introducer. The body portion62can be configured to be positioned between the distal end of the actuator of the tissue retrieval system and the bead of the tissue retrieval bag. Accordingly, the body portion62of the bead stop can comprise a channel66through which the latch arm74of the retaining latch70(FIG.8) can pass, and one or more passages68through which the support arms coupled to the actuator and cord loop of the tissue retrieval bag can pass.

When the actuator is in the proximal or first deployed positions (FIG.2andFIG.1A), the cantilever spring arm of the bead stop is in a deflected state within the introducer tube. When the retrieval bag is advanced to its fully deployed position, the cantilever spring arm springs radially outward to engage and lock into a mating slot on the introducer tube. It is contemplated that the retrieval system can be packaged and stored with the actuator in its first deployed position with the retrieval bag deployed. Thus, with the actuator in this position, the cantilever spring arm on the bead stop is subjected to a constant flexural deflection force during storage of the device. For this reason, in certain embodiments, the bead is preferably formed from a high heat polymer material with a high resistance to creep such as polyetherimide (PEI), polyphenylsulfone (PPSU), or polyetheretherketone (PEEK). In other embodiments, the bead stop can also be formed from stainless steel, spring steel, nitinol, or other metal materials. In certain embodiments, the bead stop could also be formed of a combination of materials such as a polymer body formed from polycarbonate, ABS, nylon, or polyester with a stainless steel spring arm. The stainless steel spring arm can be overmolded during molding of the bead stop, bonded to the bead stop, heat staked to the bead stop, or snap fitted to the bead stop.

While the illustrated embodiment of bead stop comprises a cantilever spring arm having a generally rectangular prismatic tab configured to engage a generally rectangular slot in the introducer tube, it is contemplated that in other embodiments, the bead stop can comprise a generally cylindrical protrusion on the cantilever spring arm to mate with a circular aperture in the introducer tube. Moreover, while the illustrated bead stop includes a single cantilever spring arm, in other embodiments, the bead stop includes two or more cantilever spring arms engageable with a corresponding two or more slots or apertures in the introducer tube.

With reference toFIGS.10and11, arrangement of the bead50, bead stop60, and retaining latch70at the distal end of the introducer3with the actuator7advanced to a first deployed position (corresponding to a tissue retrieval system positioned as illustrated inFIG.3) are illustrated. A position of the support arms40and cord loop42with the actuator7in the first deployed position is also illustrated. In the first deployed position, latch arm74of the retaining latch70extends distally from the distal end of the actuator cap and through the channel66of the bead stop60. The latch tab76at the distal end of the latch arm,74is positioned into a recess56on the bead50where it engages with the ledge57on the bead. With the retaining latch70coupled to the bead50, the retaining latch is in a non-deflected state. When the actuator7is advanced to the first deployed position, its initial position for redeployable use of the retrieval bag, the retaining latch70and the proximal portion of the bead50, which includes the recess56and the ledge57, are contained within the introducer3tube. With the retaining latch70and the proximal portion of the bead50contained within the introducer3tube, it is not possible for the retaining latch70to uncouple from the bead50as there is not sufficient clearance between the ledge57on the bead50and the inside diameter of the introducer tube for the retaining latch70to ride over the ledge57on the bead50and decouple from the bead. Therefore, with the actuator7in its first deployed position, the retaining latch70serves to enable the retrieval bag to be retracted within the introducer tube as the actuator7is pulled in a proximal direction.

With reference toFIGS.12and13, arrangement of the bead50, bead stop60, and retaining latch70at the distal end of the introducer3with the actuator7advanced to a second, fully deployed position (corresponding to a tissue retrieval system positioned as illustrated inFIG.5) are illustrated. A position of the support arms40and cord loop42with the actuator in the second deployed position is also illustrated. When the actuator is advanced to its fully deployed position, a proximal portion of the bead50and the attached retaining latch70are advanced out of the distal end of the introducer3tube. The bead stop60is also advanced distally to a position where its locking arm64or integral cantilever spring arm springs upward and locks into a rectangular mating slot4on the introducer3tube. With the bead stop60locked into the distal end of the introducer3tube, the bead stop60will prevent the bead and the retrieval bag from being withdrawn into the introducer tube.

With reference toFIGS.14and15, arrangement of the bead50, bead stop60, and retaining latch70at the distal end of the introducer3with the actuator7withdrawing from the second, fully deployed position (corresponding to a tissue retrieval system positioned as illustrated inFIG.5) are illustrated. A position of the support arms40and cord loop42with the actuator withdrawing proximally from the second deployed position is also illustrated. In the illustrated embodiment, the retaining latch70includes an angled contact surface at the latch tab76that is configured to disengage from the ledge57on the bead50during withdrawal of the actuator7and cinching of the retrieval bag. As the actuator7is retracted to cinch the retrieval bag, the bead stop60prevents the bead50from being drawn into the introducer tube. At this stage, as the retaining latch70is retracted relative to the bead50, the angled contact surface on the retaining latch70engages with the ledge57on the bead50causing the retaining latch to deflect and ride over the ledge57, resulting in a decoupling of the bead50from the retaining latch70(FIG.14). The distal tip of the retaining latch70is positioned a sufficient distance from the distal end of the introducer tube3such that the retaining latch70can deflect, ride over the ledge57(FIG.14), and then return to a non-deflected position, allowing it to be easily retracted into the introducer3tube (FIG.15) for subsequent cinching of the retrieval bag. As a proximal portion of the cord loop is coupled to the actuator7, continued withdrawal of the actuator7cinches the opening of the tissue retrieval bag (FIG.6) as the bead50bears on the body portion of the bead stop60. As the actuator7is withdrawn proximally, the support arms are withdrawn from the cuff and the bead50on the retrieval bag and tension is then applied to the cord loop to cinch the bag closed.

It can be desirable that in certain embodiments of tissue retrieval system in an initial, shipping and insertion configuration, the actuator is longitudinally slidable within the introducer only between the proximal position (FIG.2) and the first deployed position (FIG.1A). In the proximal position, the cord loop can be positioned within the introducer such that it is inaccessible. In the first deployed position, the tissue retrieval bag is coupled to the introducer. Accordingly, with the motion of the actuator limited to these positions, the potential for the tissue retrieval bag to become inadvertently decoupled from the introducer is reduced. Thus, in certain embodiments, the tissue retrieval system includes a proximal stop mechanism and a distal stop mechanism. It can be desirable that these stop mechanisms are selectively defeasible such that the actuator of a tissue retrieval system can be advanced distally beyond the first deployed position to a fully deployed position, and, once fully deployed, can be withdrawn proximally beyond the proximal position to expose the cord loop. Furthermore, it can be desirable that once the cord loop is exposed, the actuator is prevented from complete withdrawal from the introducer tube, which can create a leak path in insufflated surgical sites, and prevented from redeployment, which can undesirably advance the support arms to the surgical site. Thus, in addition to the defeasible proximal and distal stop mechanisms described above, in certain embodiments, tissue retrieval systems can comprise one or both of an actuator withdrawal stop mechanism and a redeployment lockout mechanism to limit movement of the actuator in one or both of a proximal and distal directions subsequent to cinching the tissue retrieval bag and access of the cord loop.

A proximal stop mechanism can prevent the actuator and the retrieval bag from being retracted too far into the introducer during retraction of the retrieval bag into the introducer. Prior to each insertion into the trocar during a procedure, the retrieval bag is fully retracted into the introducer by pulling the actuator in a proximal direction to the proximal position. During this retraction, the proximal stop mechanism prevents the actuator and the retrieval bag from being retracted too far into the introducer and possibly completely withdrawn from the introducer. In certain embodiments, the proximal stop mechanism also prevents the cord loop from being exposed during retraction of the retrieval bag into the introducer. In retrieval systems without features for controlling the proximal movement of the actuator, the actuator and the retrieval bag can sometimes be pulled into the handle of the device causing the retrieval bag to get jammed into the handle. Upon further proximal movement in these systems without proximal stop mechanisms, the actuator and the retrieval bag can also be pulled through the handle of the device and completely out of the introducer, causing the device to become unusable for the surgeon.

With reference toFIGS.16-19, an embodiment of proximal stop mechanism for a tissue retrieval system is illustrated. The handle can comprise an axially moveable actuator post80positioned perpendicularly to the longitudinal axis of the actuator7that allows the retrieval bag to be retracted into the introducer3tube while preventing the cord loop on the actuator from being exposed. The actuator post80can comprise a generally cylindrical body having a first end and a second end opposite the first end. The actuator post can have one or more cantilever snap legs82protruding radially outwardly from the second end. The actuator post80is positioned in a bore92formed in the handle assembly. As illustrated, the bore92is formed in a lower handle portion90of the handle assembly. The cantilever snap legs82rest on ramps94within the bore92of the lower handle and serve to maintain the actuator post80in a blocking or protruding position. A lower surface of the actuator7is sized and dimensioned to pass freely over the actuator post80as the actuator is slid longitudinally between the proximal position and the first deployed position. The lower surface of the actuator7can further comprise a ledge96formed therein and positioned to engage with the actuator post80to prevent movement of the actuator proximally past the proximal position. In this position of the actuator, the cord loop remains contained within the handle and introducer tube (FIG.2). Thus, when positioned in the protruding position, the actuator post80allows the retrieval bag to be fully retracted into the introducer tube and deployed multiple times from the introducer tube without exposing the cord loop.

In certain embodiments, the actuator post is biased to the protruding or blocking position. For example, the proximal stop mechanism can further comprise a compression spring to bias the actuator post to a protruding position to engage with the ledge on the actuator. The compression spring can be positioned within an inner diameter of the actuator post and bear against the handle assembly.

With reference toFIGS.20-22, an embodiment of proximal stop mechanism is illustrated with the actuator advanced to the second, fully deployed position. In various surgical procedures it can be desirable to withdraw the actuator proximally past the proximal position after full deployment of the tissue retrieval bag and separation of the tissue retrieval bag from the actuator. With the actuator thus proximally withdrawn, the support arms can be removed from the cuff of the tissue retrieval bag and the cord loop can be accessible such that the retrieval bag can be withdrawn from a surgical site. Thus, it can be desirable that the proximal stop mechanism is defeasible upon actuation of the actuator7to the fully deployed position.

With continued reference toFIGS.20-22, in certain embodiments, the actuator comprises a camming ramp98formed therein positioned adjacent the proximal end thereof to depress the actuator post80downward to a disengaged position relative to the actuator when the actuator is advanced to the fully deployed position. As the actuator7is advanced, the camming ramp98on the proximal end of the actuator contacts the actuator post80and cams the post downward to a non-protruding position where the cantilever snap legs82lock into the lower handle. With the actuator post80locked into a non-protruding position, the actuator7can be withdrawn proximally beyond the proximal position to fully tension the cord, cinch the retrieval bag, and expose the cord loop. With the cord loop exposed on the actuator7proximal to the handle, the surgeon can grasp and release the cord loop from the actuator, allowing the introducer and trocar to be removed from the body wall of the patient, leaving the cord loop disposed across the body wall for subsequent withdrawal of the retrieval bag from the patient.

Thus, advantageously, with a proximal stop mechanism, the cord loop of the tissue retrieval systems discussed herein are not exposed to the surgeon until the retrieval bag is cinched closed. This feature can prevent the surgeon or nurse from unintentionally grasping, cutting, releasing, or tensioning the cord loop during use of the device. In some procedures, the surgeon may need to serially contain and withdraw twenty or more tissue specimens, requiring extensive manipulation and handling of the tissue retrieval system within the patient and external to the patient by the surgeon and the nurse. The stored cord loop of the present invention obviates the chance for the cord loop to be grasped, cut, released, tensioned, or to get tangled during the extensive manipulation and handling of the device that can occur during a procedure. Without a proximal stop mechanism, other tissue retrieval systems can have a cord or line used for cinching the retrieval bag that is fully exposed to the surgeon at all times during use of the device. In certain of these devices, the cord or line is attached to the proximal end of the actuator or to the introducer handle, which can allow the surgeon or nurse to prematurely release the cord or line during the procedure resulting in the unintended release of the retrieval bag from the introducer. The cuff of the retrieval bag could also be prematurely partially cinched resulting in a reduced size of the opening of the retrieval bag and possible tearing or puncturing of the cuff of the retrieval bag by the support arms. The cord or line could also be cut or could get tangled in the device or could get tangled with other devices such as trocars during the procedure.

While defeating the proximal stop mechanism allows proximal retraction of the actuator beyond the proximal position, in certain embodiments, the handle assembly can further comprise an actuator withdrawal stop be configured to prevent complete proximal withdrawal of the actuator from the introducer tube. In certain embodiments, the handle assembly comprises a rib that mates with a slot on the actuator. The slot in the actuator has an end wall positioned to define a proximal limit of actuator travel to prevent the actuator from being fully withdrawn from the introducer during cinching of the retrieval bag for subsequent detachment of the retrieval bag from the introducer. This rib and slot combination allows the cord loop to be exposed during cinching of the retrieval bag and prevents any further retraction of the actuator. Advantageously, this actuator withdrawal stop ensures that carbon dioxide gas used to establish and maintain pneumoperitoneum within the body cavity in a surgical procedure does not leak through the introducer. In certain embodiments, a tissue retrieval system comprises an O-ring seal positioned on the actuator between the proximal end and the distal end of the actuator that maintains a seal with an inner surface of the introducer tube. Certain other retrieval systems can require that the entire actuator be withdrawn from the introducer prior to cinching of the retrieval bag. This withdrawal is typically done with the introducer inserted into a surgical site through a trocar. In these devices, as the actuator is completely withdrawn from the introducer, the retrieval bag can be hanging from the distal end of the introducer in the body cavity creating a significant leak path through the introducer for a loss of pneumoperitoneum to occur.

In certain embodiments of tissue retrieval system an O-ring that is positioned on the actuator between the proximal end and the distal end also provides an effective seal when the retrieval bag is deployed within an insufflated body cavity. The O-ring provides a seal between the actuator and the introducer tube to prevent loss of pneumoperitoneum while the surgeon is excising and placing tissue specimens in the retrieval bag. Certain other retrieval systems include seals within the handles positioned proximal to the introducer tube that attempt to seal on the actuator. These seals are not typically effective in preventing the loss of pneumoperitoneum as numerous leak paths can exist between the introducer tube and the handles, between the actuator and the introducer tube, between the upper and lower handle halves, between the handles and the introducer tube, between the seal and the actuator, and between the seal and the cord or tail of the retrieval bag.

With reference toFIGS.23A,24A,25A,26A,27A, and28A, an embodiment of distal stop mechanism is illustrated. In certain embodiments, a tissue retrieval system includes a distal stop mechanism to prevent movement of the actuator distally past a first deployed position in which the tissue retrieval bag remains coupled to the actuator (FIG.1A). Desirably, such a stop allows repeated deployment of the tissue retrieval bag to sequentially retrieve multiple tissue specimens. In certain embodiments, it is desirable that the distal stop mechanism is selectively releasable or defeasible such that a surgeon can control advancement of the actuator distal of the first deployed position to a fully deployed position in which the tissue retrieval bag can be separated from the actuator.

With reference toFIGS.23A,24A,25A, and26A, the distal stop mechanism can comprise a selectively releasable deployment latch. In certain embodiments, the deployment latch can comprise a deployment release button110positioned in the handle assembly. As illustrated, the deployment release button110is nested into the upper handle. As illustrated, the button110includes walls112that extend along each side of the actuator7. The walls112include radially inwardly extending latch tabs or stop tabs114and recesses116positioned radially outwardly of the stop tabs114. The deployment release button110includes two posts118extending from a lower surface of the walls112. Each of the posts118can be positioned in a corresponding bore in the handle assembly and can retain a compression spring120such that the posts118and compression springs120are nested into the lower handle. The compression springs120bias the button110upward when the handle assembly is oriented as illustrated inFIG.26A. In the illustrated embodiment, the button110has a generally triangular shape aligned to convey to a user a direction of travel of the actuator7. In other embodiments, the deployment release button can have a square, circular, oval, or other shape. In certain embodiments an icon or stylized logo can be added to the button to convey information to a user.

With continued reference toFIGS.23A,24A,25A, and26A, the actuator7can comprise radially protruding ribs130adjacent the proximal end thereof. In certain embodiments, the actuator can comprise a separately molded thumb loop132, which can be pressed onto the actuator7via interference pins and holes. The thumb loop132can include the ribs130molded along its longitudinal axis.

With reference toFIGS.25A and26A, the handle assembly of a tissue retrieval system is illustrated with the actuator in a first deployed position and a distal stop mechanism engaged such that the deployment latch is in a latched configuration. The deployment release button110is biased upward such that the stop tabs114of the walls112interfere with and block distal movement of the ribs130of the actuator7. As the actuator7is initially advanced to deploy the retrieval bag, the ribs on the thumb loop contact the walls on the button and prevent the actuator from being advanced beyond its initial position. Thus, when the deployment release button110is not pressed, the button110allows the actuator7to only be advanced to the first deployed position, with the retrieval bag deployed from a distal end of the introducer but coupled to the actuator and where the retrieval bag can be subsequently retracted into the introducer (FIG.1A).

With reference toFIGS.27A and28A, the handle assembly of a tissue retrieval system is illustrated with the actuator in a second, fully deployed position and a distal stop mechanism released. When it is desired to release the tissue retrieval bag from the actuator during a procedure, a surgeon can depress the deployment release button110on the handle assembly. When the button110is pressed downward, the walls112on the button move to position the stop tabs114out of alignment with the ribs130on the actuator7allowing the actuator to then be advanced to its fully deployed position. As the actuator7is advanced, the ribs130can slide within the recesses116of the walls112. The compression springs120bias the button110upward and serve to return the button to a raised position (FIGS.25A,26A) after the button110has been pressed and then released. Thus, when the button110is pressed downward to defeat the distal stop mechanism, the actuator can then be advanced to its fully deployed position, where the retrieval bag can subsequently be cinched closed and detached from the introducer. In certain embodiments, advancing the actuator to the fully deployed position also defeats a proximal stop mechanism such as the actuator post described and illustrated with reference toFIGS.16-22. The actuator can then be fully retracted to tension the cord loop, cinch the retrieval bag, and expose the small loop of cord on the actuator.

With reference toFIGS.23B,24B,25B,26B,27B, and28B, another embodiment of distal stop mechanism is illustrated. Similar to the embodiment discussed above with reference toFIGS.23A,24A,25A, and26A, the distal stop mechanism can comprise a selectively releasable deployment latch. In certain embodiments, the deployment latch can comprise a deployment release button111positioned in the handle assembly. As illustrated, the deployment release button111is nested into the upper handle. As illustrated, the button111includes walls113that extend along each side of the actuator7. The walls113include radially inwardly extending latch tabs or stop tabs115and recesses117positioned radially outwardly of the stop tabs115. The deployment release button111includes two posts119extending from a lower surface of the walls113. Each of the posts119can be positioned in a corresponding bore in the handle assembly and can retain a compression spring120such that the posts119and compression springs120are nested into the lower handle. The compression springs120bias the button111upward when the handle assembly is oriented as illustrated inFIG.26B. In the illustrated embodiment, the button111has a generally triangular shape aligned to convey to a user a direction of travel of the actuator7. In other embodiments, the deployment release button can have a square, circular, oval, or other shape. In certain embodiments an icon or stylized logo can be added to the button to convey information to a user.

With continued reference toFIGS.23B,24B,25B, and26B, the actuator7can comprise at least one longitudinally extending rail, slot, or groove131positioned such that the stop tabs115of the button111are in sliding engagement with an upper edge of the groove131. The button111is biased such that the stop tabs115are adjacent the upper edge of the groove131. In certain embodiments, the button can be sized and configured such that the stop tabs115are adjacent but out of contact with the upper edge of the groove131to prevent frictional contact therebetween as the actuator7is slid. As illustrated, the groove131comprises a proximal end wall133adjacent the proximal end thereof. The groove131further comprises a deployment segment135proximal the proximal end wall133. The deployment segment can extend along an axis parallel to a longitudinal axis of the portion of the groove131distal of the proximal end wall133and offset therefrom by a height of the proximal end wall133.

With reference toFIGS.25B and26B, the handle assembly of a tissue retrieval system is illustrated with the actuator in a first deployed position and a distal stop mechanism engaged such that the deployment latch is in a latched configuration. The deployment release button111is biased upward such that the stop tabs115of the walls113interfere with the proximal end wall133of the groove131and block further distal movement of the actuator7. Thus, when the deployment release button111is not pressed, the button111allows the actuator7to only be advanced to the first deployed position, with the retrieval bag deployed from a distal end of the introducer but coupled to the actuator and where the retrieval bag can be subsequently retracted into the introducer (FIG.1A).

With reference toFIGS.27B and28B, the handle assembly of a tissue retrieval system is illustrated with the actuator in a second, fully deployed position and a distal stop mechanism released. When it is desired to release the tissue retrieval bag from the actuator during a procedure, a surgeon can depress the deployment release button111on the handle assembly. When the button111is pressed downward, the walls113on the button move to position the stop tabs115out of alignment with the proximal end wall133of the groove131on the actuator7and into alignment with the deployment segment135of the groove, allowing the actuator to then be advanced to its fully deployed position. As the actuator7is advanced, the stop tabs115can slide within the deployment segment135of the groove131. The compression springs120bias the button111upward and serve to return the button to a raised position (FIGS.25B,26B) after the button111has been pressed and then released. Thus, when the button111is pressed downward to defeat the distal stop mechanism, the actuator can then be advanced to its fully deployed position, where the retrieval bag can subsequently be cinched closed and detached from the introducer. In certain embodiments, advancing the actuator to the fully deployed position also defeats a proximal stop mechanism such as the actuator post described and illustrated with reference toFIGS.16-22. The actuator can then be fully retracted to tension the cord loop, cinch the retrieval bag, and expose the small loop of cord on the actuator.

With reference toFIGS.27C and28C, the handle assembly of a tissue retrieval system is illustrated with the actuator proximally retracted to a position corresponding to a cinched tissue retrieval bag (FIG.6A) following full deployment of the tissue retrieval bag. In some embodiments, the distal stop mechanism ofFIGS.23B,24B,25B,26B,27B, and28Bfurther comprises a redeployment latch mechanism. As illustrated, the groove131of the actuator extends longitudinally distally along the actuator7to a position corresponding to a proximally retracted position of the actuator7with the tissue retrieval bag in a cinched configuration (FIG.6A). The groove131comprises a redeployment latch ramp137, a redeployment latch end wall139, and a redeployment latch segment141formed in an upper edge of the groove and positioned longitudinally on the actuator7adjacent this proximally retracted position. Thus, as the actuator is proximally retracted relative to the handle assembly to cinch the tissue retrieval bag, the stop tabs115of the button111are biased into engagement with the redeployment latch ramp137, over the redeployment latch end wall139, and adjacent to an upper edge of the redeployment latch segment141, as illustrated inFIG.28C. An attempt to distally advance the actuator7from this proximally retracted position would cause the stop tabs115to engage the redeployment latch end wall139, restricting further distal movement of the actuator7. Thus, the redeployment latch mechanism can desirably prevent unintended redeployment of the support arms once the tissue retrieval system has been operated to fully cinch the tissue retrieval bag.

With reference toFIGS.29-30, in certain embodiments a tissue retrieval system can include a bead stop160having a snap ring162such as a stainless steel snap ring rather than a bead stop60as described an illustrated with respect toFIG.9. Other aspects of the tissue retrieval systems described above can be used in combination with the bead stop160. A slot30in the introducer tube can be sized and configured to receive snap ring162to lockingly engage the bead stop160. The snap ring would remain in a compressed state within the introducer tube with the actuator in its first deployed position for redeployable use of the retrieval bag. When the actuator7is advanced to its fully deployed position (FIGS.29-30) to enable cinching of the retrieval bag, the snap ring expands into the slot162on the introducer tube and prevents the bead50and retrieval bag from being retracted into the introducer tube. The snap ring162can comprise a gap164formed therein and aligned with a corresponding gap in the bead stop160, and the retaining latch70can extend through the gap164.

With reference toFIGS.31A and32A, in certain embodiments a tissue retrieval system can include a bead stop260having a spring-biased clip262rather than a bead stop60as described an illustrated with respect toFIG.9. Other aspects of the tissue retrieval systems described above can be used in combination with the bead stop260. The introducer tube can include an aperture sized and configured to receive the clip262to lockingly engage the bead stop when the actuator is moved to a fully deployed position. The bead stop260can further comprise a compression spring264positioned between the clip262and the bead stop body. The clip262remains in a compressed state with the actuator between the proximal position and the first deployed position for redeployable use of the retrieval bag. When the actuator is advanced to its fully deployed position to enable cinching of the retrieval bag, the clip262is driven upward by the compression spring264to engage with the aperture in the introducer tube to prevent the bead and retrieval bag from being retracted into the introducer tube. The bead stop260can comprise a channel266through which a retaining latch of a tissue retrieval system can extend. The bead stop260can further comprise a pair of axially spaced slots268and a passage sized and configured to receive support arms and the cord loop of the tissue retrieval system therethrough.

With reference toFIGS.31B and32B, in certain embodiments a tissue retrieval system can include another embodiment of bead stop261having a spring-biased clip263similar to the bead stop260ofFIGS.31A and32A. The bead stop261can further comprise a compression spring265positioned between the clip263and the bead stop body. The bead stop261can comprise a channel267through which a retaining latch of a tissue retrieval system can extend. Unlike the bead stop260ofFIGS.31A and32A, the channel267of the bead stop261can be contiguously formed with a central recess269sized and configured to receive support arms and the cord loop of the tissue retrieval system therethrough. Desirably, this central recess269contiguously formed with the channel267enhances ease and speed of assembly of the bead stop261with the support arms and cord loop during assembly of the tissue retrieval system.

With reference toFIGS.33-35, in certain embodiments, a redeployable tissue retrieval system can comprise an actuator cap having a rotatable retaining latch. As illustrated, the actuator cap170includes a forked distal extension172with a rotating latch174positioned on a pin176within the fork on the extension. The rotating latch174can rotate about the pin176and releasably couples with the ledge57on the bead50to retain the bead50and the retrieval bag to the actuator7. With the actuator7slidable between the proximal position and first deployed position (FIG.34) for redeployable use of the retrieval bag, the rotating latch174is engaged with the ledge57on the bead50and is constrained from rotating by the introducer3tube. When the actuator is advanced to its fully deployed position (FIG.35) to enable cinching of the retrieval bag, the rotating latch174is positioned outside of the introducer3tube and is free to rotate. As the actuator7is retracted to cinch the retrieval bag, the rotating latch174rotates to a position to where it decouples from the bead50. In certain embodiments of tissue retrieval system, the actuator cap170having a rotating latch174can be used without a bead stop (FIGS.34-35). With no bead stop, the retrieval bag material near the bead50can bunch up outside of the introducer3tube to enable cinching. In other embodiments, the actuator cap170having a rotating latch174can be used in combination with a bead stop. In these embodiments, the forked extension on the actuator cap170extends through a channel in the bead stop.

With reference toFIGS.36-38, in certain embodiments, a tissue retrieval system can comprise a bead150having a radially expandable element such as a snap ring152positioned thereon. The snap ring152can be positioned around a proximal portion of the bead150. The proximal portion of the bead150with the snap ring152remains within the introducer3tube with the actuator slidable between the proximal position and the first deployed position for redeployable use of the retrieval bag. During redeployable use of the retrieval bag, the snap ring152would remain in a compressed state within the introducer3tube and have a first outer diameter defined by an inner diameter of the introducer3tube. When the actuator is advanced to its fully deployed position (FIGS.37-38), the snap ring152would be positioned outside of the introducer tube where it would expand to a second outer diameter larger than the inner diameter of the introducer tube and would prevent the bead and the retrieval bag from being retracted into the introducer3tube, enabling the cinching of the retrieval bag. Thus, in these embodiments tissue retrieval systems can prevent reentry of the bead into the introducer without a bead stop. The snap ring152comprises a gap154to accommodate the retaining latch70. In the illustrated embodiment, the retaining latch70extends through the gap154in the snap ring152such that the distal tip of the retaining latch70would be positioned distal to the snap ring152. With the actuator advanced distally to the second deployed position, as the snap ring152contacts the distal end of the introducer tube, the distal tip of the retaining latch70would be positioned outside of the introducer tube and would decouple from the ledge157on the bead150as the actuator is retracted.

In other embodiments including a guide bead150with snap ring152, the distal tip of the retaining latch70is positioned proximal to the snap ring such that the retaining latch remains positioned within the introducer tube with the actuator in the fully deployed position. When the actuator is advanced to its fully deployed position, the snap ring would expand to prevent the bead and the retrieval bag from being retracted into the introducer tube. The distal tip of the retaining latch would mate with a slot in the introducer tube sufficiently sized to allow the retaining latch to deflect and decouple from the ledge on the bead and enable cinching of the retrieval bag.

With reference toFIGS.39-42, in certain embodiments, a tissue retrieval system can comprise a bead250including an O-ring252that would serve to prevent the bead250and the retrieval bag from being retracted into the introducer tube to enable cinching of the retrieval bag. Thus, in these embodiments tissue retrieval systems can prevent reentry of the bead into the introducer without a bead stop. In the illustrated embodiment, the O-ring252is positioned around a proximal portion of the bead250. The proximal portion of the bead with the O-ring remains within the introducer3tube with the actuator in its initial position slidably movable between the proximal position and first deployed position for redeployable use of the retrieval bag. During redeployable use of the retrieval bag, the O-ring252would remain in a compressed state within the introducer tube. When the actuator is advanced distally to its fully deployed position (FIGS.39-40), the O-ring252would be positioned outside of the introducer tube where it would expand to a larger diameter and would prevent the bead250and the retrieval bag from being retracted into the introducer tube, enabling cinching of the retrieval bag.

With continued reference toFIGS.39-42, in certain embodiments of tissue retrieval system, a guide bead250having an O-ring252is be used in conjunction with one or two retaining latches270. In the illustrated embodiment, the retaining latches270releasably engage the bead250proximal to the O-ring252and remain positioned within the introducer tube with the actuator advanced to a fully deployed position. The introducer3tube can comprise corresponding slots30sized and positioned to allow the retaining latches to deflect radially outwardly (FIG.41) to decouple from the ledges on the bead and enable cinching of the retrieval bag (FIG.42). In various embodiments, the retaining latches comprise separate components mechanically trapped, pivotably coupled, or otherwise attached to the actuator cap. In certain embodiments, the retaining latches are biased radially outwardly. For example, in certain embodiments, the retaining latches include integral leaf springs to bias the latches to a radially expanded position.

With reference toFIGS.43-55, in certain embodiments, it is desirable that the bead is securely coupled to the retrieval bag to remain coupled for multiple deployment and cinch cycles of the retrieval bag in a surgical procedure. In still other embodiments, certain aspects of the beads ofFIGS.43-55can be combined with other aspects described with respect to the beads ofFIGS.36-42.

With reference toFIGS.43-45, in certain embodiments, the bead350on the retrieval bag is comprised of two halves352,354that are pressed together via interference pins356and holes358or that are ultrasonically welded together. In the illustrated embodiment, the lower bead half352further comprises a vertical post360that is sized and configured to fit through a proximal end of the retrieval bag20. The proximal end of the retrieval bag20includes a belt22that is heat sealed together and engages the post360on the lower bead half352to securely couple the bead350to the retrieval bag20. The cord loop42can be routed on the outside of the belt. The upper bead half354is placed over the post to mechanically trap the belt22of the retrieval bag20within the bead halves352,354. Each upper and lower bead half352,254can include a semi-circular groove362at its center along its longitudinal axis that is positioned at the proximal end of the bead350and is sized and configured to frictionally engage the cord loop. When the bead halves are assembled together, the semi-circular grooves362form a circular aperture creating a frictional fit with the cord, allowing the retrieval bag to be cinched closed and reopened. The bead halves can include angled guides364and mating slots for the guides surrounding the semi-circular grooves that aid with centering the cord loop within the grooves during assembly of the bead. In the illustrated embodiment, the lower bead half352includes the recess357and ledge359for coupling with the retaining latch.

With reference toFIGS.46-48, in certain embodiments, the bead450on the retrieval bag is comprised of two halves452,454that are ultrasonically welded together to securely couple the bead450to the retrieval bag20. In the illustrated embodiment, the right bead half452includes an oval post456that is sized and configured to mate with a corresponding oval hole26in the proximal end of the retrieval bag20. In certain embodiments, the proximal end of the retrieval bag20includes a die cut oval hole26that fits over the post in the right bead half. The cord loop42can be routed above or below the post. The left bead half454is placed over the post456to mechanically trap the proximal end of the retrieval bag20and the bead halves452,454are coupled such as by ultrasonically welding. Each of the right and left bead halves452,454also include a semi-circular groove458. The semi-circular grooves458can be positioned at the proximal end of the bead450. With the bead halves452,454coupled (FIG.47), the semi-circular grooves458collectively form a central passage through the bead450that can be sized to frictionally engage the cord loop. The right and left bead halves452,454each include a portion of a recess457and ledge459for coupling with the retaining latch.

With continued reference toFIGS.46-48, while the illustrated bead includes a single post positioned to retain the bag, in other embodiments, the right bead half includes two or more posts such as, for example, circular posts designed to mate with corresponding die cut holes in the proximal end of the retrieval bag. Moreover, in certain embodiments, the proximal end of the retrieval bag20with the die cut oval hole includes a reinforcement material to increase the retention strength of the retrieval bag to the bead. In various embodiments, the reinforcement material can be ripstop nylon, polyurethane, nylon, or other suitable materials.

With reference toFIGS.49-51, in certain embodiments the bead550on the retrieval bag is comprised of a proximal section552and a distal section554that are pressed together via interference pins556and holes558. In the illustrated embodiment, the bead also includes an annular interference fit for retaining the retrieval bag20to the bead550and for affixing the proximal and distal sections552,554of the bead550together. The distal section554of the bead also includes an annular ledge557designed to further retain the retrieval bag to the bead. To assemble the bead550, the cord loop42is first threaded through each of the bead sections552,554and the distal section554of the bead is then inserted through the distal end of a tubular portion of the retrieval bag. The proximal section552of the bead is then placed over the distal section554of the bead and the retrieval bag20and the two sections of the bead are pressed together trapping the tubular portion of the retrieval bag. In certain embodiments, the distal section554of the bead can include a slot rather than a through hole to obviate the need for threading the cord loop through the distal section554of the bead. In certain embodiments, an adhesive could be applied to the annular interference fit and the interference pins to further increase the retention of the retrieval bag20to the bead550. In the illustrated embodiment, the proximal section552of the bead includes the recess560and ledge562for coupling with the retaining latch.

With reference toFIGS.52-55, in certain embodiments, the bead650on the retrieval bag is comprised of two substantially identical halves652that are ultrasonically welded together. The bead half652includes an energy director654for ultrasonically welding the bead halves together. The bead half also includes multiple energy directors656for ultrasonically welding the external proximal portions of the retrieval bag between the bead halves652. To assemble the retrieval bag to the bead650, the retrieval bag is sandwiched between the bead halves652, and the bead halves are subsequently ultrasonically welded to the outside of each side of the retrieval bag. The bead halves650can concurrently be ultrasonically welded together or can be welded together as a secondary step. The cord loop is positioned within a central recess during welding to ensure that the cord loop is not welded to the bead or the retrieval bag during assembly. The bead half also includes a semi-circular groove658at its center along its longitudinal axis at the proximal end of the bead that is designed to frictionally engage the cord loop. The bead half652includes guides660and mating slots for the opposing guides surrounding the semi-circular grooves658that aid with centering the cord loop within the grooves during assembly of the bead. The bead half includes a recess and ledge662for coupling with a retaining latch.

With reference toFIGS.56-61, in certain embodiments, the handle assembly comprises a pawl assembly. The pawl assembly can be configured to provide both a secondary proximal stop mechanism and a redeployment lockout mechanism.

With reference toFIGS.56-58, the pawl assembly can comprise a pawl702pivotally coupled to the handle assembly and a pawl spring704. The pawl spring704is positioned around the pawl702and biases the pawl702to a centered position. With the actuator in its initial position slidable between the proximal position and the first deployed position for redeployable use of the retrieval bag, the pawl702is canted towards the distal end of the device. The actuator7comprises a longitudinally extending rib710having a first recess712formed therein. The pawl702slides along the rib710as the actuator is being proximally withdrawn from the first deployed position (FIG.56). As the actuator7is withdrawn to retract the retrieval bag into the introducer tube, the pawl702will drop into the first recess712on the actuator7and will engage a distal wall714of the recess712to prevent any further proximal movement of the actuator (FIGS.57-58). Desirably the first recess712is positioned on the rib at a location to engage the pawl at an actuator position corresponding to the proximal position of the actuator to ensure that the cord loop is not exposed. Thus, in certain embodiments, the handle assembly includes a secondary proximal stop mechanism preventing the retrieval bag from being withdrawn too far into the introducer tube such that the cord loop would be exposed. In other embodiments, the pawl assembly can provide a primary proximal stop mechanism and no actuator post as described with reference toFIGS.16-22is present in the handle assembly.

With reference toFIGS.59-61, when the actuator is advanced to its fully deployed position for subsequent cinching of the retrieval bag, the pawl702is moved off of a proximal end of the rib710and moves to a centered position (FIG.59). When the actuator7is withdrawn proximally to begin cinching of the retrieval bag, the pawl702will be pivoted towards the proximal end of the device as it engages the proximal end of the rib710. The rib710further comprises a second recess716located distal the first recess712. When the actuator7is fully withdrawn with the retrieval bag cinched closed, the cord loop is exposed and the pawl702drops into the second recess716on the rib710(FIG.60). The pawl702engages with the proximal wall718of the second recess716to prevent the actuator7from being advanced distally (FIG.61). This engagement of the pawl702with the second recess716defines a redeployment lockout mechanism to prevent the actuator from being inadvertently advanced by the surgeon once the retrieval bag has been decoupled from the actuator and cinched. If the actuator were inadvertently redeployed, it could undesirably result in the support arms being advanced out of the distal end of the introducer. The pawl assembly also retains the actuator in its fully withdrawn position enabling easier removal of the cord loop from the actuator.

Thus, the illustrated embodiment of pawl assembly engages a first recess and a second recess on the rib of the actuator to provide both a proximal stop mechanism and a redeployment lockout mechanism. However, it is contemplated that in other embodiments, the rib comprises a single recess positioned such that the pawl assembly can be configured to provide only one of a proximal stop mechanism or a redeployment lockout mechanism.

With reference toFIGS.62-64, in certain embodiments, a distal stop mechanism can be included in the actuator720rather than the handle assembly. Thus, the handle assembly can be provided without the deployment release button110described and illustrated with respect toFIGS.23-28. As illustrated, the actuator720comprises a cantilever722positioned to limit the distal advancement of the actuator to the first deployed position for redeployable use of the retrieval bag. In the illustrated embodiment, the cantilever722is integral to a thumb loop724of the actuator720, which can be pressed onto the actuator via interference pins and holes. A distal tip of the cantilever722contacts the upper handle during deployment of the retrieval bag to limit the travel of the actuator at the first deployed position (FIGS.63,64). To further advance the actuator, the cantilever722can be pressed downward to where it fits into an opening on the upper handle. The actuator720can then be advanced to its fully deployed position. In various embodiments, the thumb loop720including cantilever722can be injection molded from various polymer materials including polycarbonate, nylon, ABS, and polypropylene.

With reference toFIGS.65-66, in certain embodiments a tissue retrieval system can comprise a tissue retrieval bag having a distally extending portion. While the tissue retrieval bags described and illustrated with respect toFIGS.1-6have an open end with a cuff supported by support arms and extend generally perpendicularly to a longitudinal axis of the support arms to a closed end opposite the open end, in certain embodiments, the tissue retrieval systems described herein can include a retrieval bag20′ formed with a distally extending portion22′ where the retrieval bag extends distally relative to the opening24′ of the retrieval bag. Desirably, a retrieval bag20′ with a distally-extending portion provides a more streamlined shape that reduces the force required to retract the retrieval bag20′ into the introducer3tube (FIG.66) and reduces the force to extract the detached retrieval bag through the body wall of the patient relative to a tissue retrieval bag20without a distally-extending portion. The retrieval bag20′ with the distally extending portion22′ can also provide for a larger volume of the retrieval bag being available for small tissue specimens when the retrieval bag20′ is partially retracted into the introducer tube and the opening is reversibly closed.

Although this application discloses certain aspects of various features of redeployable tissue retrieval systems, it is contemplated that certain elements described herein can be combined in certain embodiments of tissue retrieval systems. For example, in one embodiment, a tissue retrieval system can include a handle assembly having a deployment button111and actuator7with groove131as described with reference toFIGS.23B,24B,25B,26B,27B,28B,27C,28C, together with a bead stop261with a spring-biased clip as described with reference toFIGS.31B and32B. However, in other embodiments, other beads, bead stops, latch members, and stop mechanisms described herein can be combined in tissue retrieval systems within the scope of the present application.

Although this application discloses certain preferred embodiments and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the inventions and obvious modifications and equivalents thereof. Further, the various features of these inventions can be used alone, or in combination with other features of these inventions other than as expressly described above. Thus, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims which follow.