SPECIMEN RETRIEVAL DEVICE

A specimen retrieval device includes a tubular body defining a longitudinal bore, an inner shaft slidably disposed within the longitudinal bore of the tubular body, and a specimen bag affixed to a support mechanism at the distal portion of the inner shaft. In embodiments, the specimen bag has an opening capable of being closed by an interlocking assembly after placement of tissue therein, but prior to removal of the device from the body.

TECHNICAL FIELD

The present disclosure relates generally to surgical apparatuses for use in minimally invasive surgical procedures, such as endoscopic and/or laparoscopic procedures and, more particularly, the present disclosure relates to specimen retrieval devices including an opening that may be closed after placement of a tissue specimen therein.

BACKGROUND

Minimally invasive surgery, such as endoscopic surgery, reduces the invasiveness of surgical procedures. Endoscopic surgery involves surgery through body walls, for example, viewing and/or operating on the ovaries, uterus, gall bladder, bowels, kidneys, appendix, etc. There are many common endoscopic surgical procedures, including arthroscopy, laparoscopy, gastroentroscopy and laryngobronchoscopy, just to name a few. In these procedures, trocars are utilized for creating incisions through which the endoscopic surgery is performed. Trocar tubes or cannula devices are extended into and left in place in the abdominal wall to provide access for endoscopic surgical tools. A camera or endoscope is inserted through a trocar tube to permit visual inspection and magnification of a body cavity. The surgeon can then perform diagnostic and/or therapeutic procedures at the surgical site with the aid of specialized instrumentation, such as forceps, graspers, cutters, applicators, and the like, which are designed to fit through additional cannulas.

When removing certain tissues from the body cavity, for example tumor tissue, it is important that the tumor tissue does not come into contact with healthy or uninvolved tissue. If tumor tissue or tissue parts have to be removed, they may be introduced into an “extraction bag,” also referred to herein as a “specimen bag,” at the site where the tumor or diseased tissue has been detached from the surrounding tissue, after which the specimen bag is withdrawn from the body, thereby minimizing contact of the diseased tissue with healthy tissue.

Improved specimen bags for use in minimally invasive surgical procedures remain desirable.

SUMMARY

Specimen retrieval devices in accordance with the present disclosure include a pouch that is selectively detachable from the device. In embodiments, a specimen retrieval device of the present disclosure includes a tubular body defining a longitudinal bore, the tubular body having a proximal portion, a distal portion, and a hand grip supported on the proximal portion of the tubular body; an inner shaft having a proximal portion, a distal portion, an actuation handle supported on the proximal portion of the inner shaft, and a support member extending from a distal portion of the inner shaft; a specimen bag supported on the support member at the distal portion of the inner shaft, the specimen bag including a body defining an opening that is opened and closed by an interlocking assembly, the interlocking assembly including a first interlocking element on one side of the opening, a second interior interlocking element on the opposite side of the opening, and a slider that is movable along the opening to close the opening; and at least one pull string having a proximal portion and a distal portion affixed to the slider, the pull string being movable to move the slider along the opening to close the opening of the specimen bag.

In some embodiments, the support member includes a pair of resilient fingers which support the specimen bag and open the open end of the specimen bag in a deployed state. The resilient fingers may be positioned adjacent the open end of the specimen bag to open the specimen bag when the specimen retrieval device is in the deployed state.

In other embodiments, the specimen bag is furled about the inner shaft in a non-deployed state.

In embodiments, the slider interlocks the first interlocking element and the second interior interlocking element when moved in a closing direction. In some embodiments, the interlocking assembly includes a tongue and groove closure. In other embodiments, the interlocking assembly is a zipper assembly.

In embodiments, the proximal portion of the pull string extends proximally from the actuation handle. In some embodiments, the at least one pull string includes two pull strings, each pull string having a proximal portion and a distal portion affixed to the slider, each pull string moving through a channel of the inner shaft to move the slider to close the opening of the specimen bag. In other embodiments, the proximal portion of each of the two pull strings extends proximally from the actuation handle.

Methods for utilizing the specimen retrieval devices of the present disclosure are also provided. In embodiments, methods of the present disclosure include introducing into a body opening a specimen retrieval device, the specimen retrieval device including a tubular body defining a longitudinal bore and including a proximal portion and a distal portion. The specimen retrieval device also includes an inner shaft having a proximal portion, a distal portion, an actuation handle supported on the proximal portion of the inner shaft, and a support member extending from a distal portion of the inner shaft, the inner shaft capable of passage through the longitudinal bore of the outer shaft; a specimen bag supported on the support member at the distal portion of the inner shaft, the specimen bag including a body defining an opening that is opened and closed by an interlocking assembly, the interlocking assembly including a first interlocking element on one side of the opening, a second interior interlocking element on the opposite side of the opening, and a slider; and at least one pull string having a proximal portion and a distal portion affixed to the slider, the pull string moving through at least one channel of the inner shaft to move the slider to close the opening of the specimen bag. The method further includes inserting the specimen retrieval device through an incision so the distal portion of the tubular body is in a body cavity; passing the distal portion of the inner shaft through the tubular body so that the distal portion of the inner shaft and the specimen bag are distal to the distal portion of the tubular body; passing a tissue specimen through the opening of the specimen bag into the specimen bag; moving the slider to close the interlocking assembly, thereby closing the opening in the specimen bag; and removing the specimen retrieval device from the body cavity.

In embodiments, the method of the present disclosure further includes breaking up the tissue specimen in the specimen bag prior to removing the specimen retrieval device from the body cavity.

In some embodiments, moving the slider interlocks the first interlocking element and the second interior interlocking element, thereby closing the opening in the specimen bag.

In other embodiments, proximally pulling the pull string moves the slider to close the interlocking assembly.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present disclosure provides a specimen retrieval device for use in minimally invasive surgical procedures. As used herein with reference to the present disclosure, minimally invasive surgical procedures encompass laparoscopic procedures, arthroscopic procedures, and endoscopic procedures, and refer to procedures utilizing scopes or similar devices having relatively narrow operating portions capable of insertion through a small incision in the skin.

The aspects of the present disclosure may be modified for use with various methods for retrieving tissue specimens during minimally invasive surgical procedures, sometimes referred to herein as minimally invasive procedures. Examples of minimally invasive procedures include, for example, cholecystectomies, appendectomies, nephrectomies, colectomies, splenectomies, and the like.

The presently disclosed specimen retrieval device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. The term “clinician” is used generally to refer to medical personnel including doctors, surgeons, nurses, and support personnel.

Referring toFIGS. 1-7, and initially with reference toFIGS. 1-4, the specimen retrieval device10of the present disclosure includes a tubular body12having a proximal portion16and a distal portion18, and defines a longitudinal bore14that extends between the proximal portion16and the distal portion18. The tubular body12has a hand grip15thereon. The specimen retrieval device10also includes an inner shaft assembly20(FIG. 3) including an inner shaft22slidably positioned within the longitudinal bore14of the tubular body12, an actuation handle25secured to a proximal portion24of the inner shaft22, and a specimen bag40(FIG. 1) supported on a distal portion26of the inner shaft22.

The hand grip15on the tubular body12may be formed as a unitary component or, as depicted inFIG. 4, as two separate half components15a,15b, that are coupled to one another about the tubular body12by one or more suitable coupling methods (e.g., one or more suitable adhesives). In the latter instance, an indent/detent configuration (not shown) may be utilized to facilitate coupling the two separate half components on15a,15bto one another.

The actuation handle25on the inner shaft22may likewise be formed as a unitary component or, in embodiments, as depicted inFIG. 4, as two separate half components25a,25bthat are coupled to one another by one or more suitable coupling methods (e.g., one or more suitable adhesives). An O-ring27(FIG. 4) may be secured to the proximal portion24of the inner shaft22. The O-ring27is configured to provide adequate clearance between the tubular body12and the inner shaft22so as to allow unhindered translation of the inner shaft22with respect to the tubular body12when the inner shaft22is translated in the proximal and/or distal directions. Moreover, the O-ring27also provides a fluid tight seal to maintain any insufflation gases in a working space, e.g., within a body cavity of a patient.

In an assembled configuration, the hand grip15and the actuation handle25can be manipulated to facilitate manipulation of the specimen retrieval device10and the sliding of the inner shaft22within the tubular body12. More specifically, the hand grip15can be grasped by the clinician with one hand and the actuation handle25can be grasped by the clinician with the other hand to move the inner shaft22within the tubular body12.

The tubular body12and/or the inner shaft assembly22of the present disclosure are made of biocompatible materials within the purview of those skilled in the art, in embodiments, polymeric materials. For example, the tubular body12and/or the inner shaft assembly22may be made of thermoplastic polyurethanes sold under the name PELLETHANE®, which offer flexibility and a wide range of hardness. The tubular body12and/or the inner shaft assembly22, for example, may be fabricated from PELLETHANE® 2363-80A, PELLETHANE® 2363-90A, PELLETHANE® 2363-55D, any combination thereof, or any alternatives within the purview of those skilled in the art.

In some embodiments, the tubular body12and the inner shaft assembly22are formed of the same material. In other embodiments, the tubular body12and the inner shaft assembly22are formed of different materials.

The specimen bag40includes a body44having a generally tubular or elongated configuration that is defined by an openable and closable portion (or mouth)42and a closed portion46. The closable portion42defines an opening45. Alternatively, other specimen bag configurations are envisioned. Referring toFIG. 4, the distal portion26of the inner shaft22is coupled to a support member28that is configured to support the specimen bag40. In embodiments, the support member28includes a pair of resilient fingers30,32that extend distally from the distal portion26of the inner shaft22. In embodiments, the resilient fingers30,32can be integrally formed with the distal portion26of the inner shaft22such as by molding.

Alternatively, as depicted inFIG. 4, a retention pin29may be used to attach the resilient fingers30,32to the distal portion26of the inner shaft22. The resilient fingers30,32are movable from a spaced non-deformed state (FIG. 1) to a deformed state (FIG. 3) to facilitate placement of the specimen bag40into the tubular body12. The resilient fingers30,32return to the non-deformed state when the specimen bag40is deployed from the tubular body12to open the opening42of the specimen bag40, as described below. Alternately, the specimen bag40can be supported on the distal portion26of the inner shaft22using other fastening or securing techniques.

The body44of the specimen bag40may be made from any suitable biocompatible material (e.g., nylon, urethane, ripstop nylon or latex) capable of forming a flexible collapsible member, or membrane. In embodiments, the material from which the specimen bag is made is resilient, antistatic, pyrogen-free, non-toxic, and sterilizable. In embodiments, materials used to form the tubular body12and/or the inner shaft22described above may be used to form the specimen bag40. In other embodiments, the specimen bag40is formed of materials that are different from those used to form the tubular body12and/or the inner shaft22. The specimen bag40may be opaque or clear.

As depicted inFIGS. 1, 2, 6, and 7, the mouth42of the specimen bag40includes an interlocking assembly50which, when opened, forms the opening45of the specimen bag40. The interlocking assembly50includes a first interlocking element52on one side of the opening44, and a second interlocking element54on the opposite side of the opening45(FIG. 2). The first and second interlocking elements52,54include male and female interlocking elements, which can be reversed, or other interlocking configurations can be used.

Returning toFIG. 2, the interlocking assembly50also includes a slider56mounted on the proximal ends of first and second interlocking elements52,54. The slider56operates in a conventional manner of separating the first and the second interior interlocking elements52,54when moved in an opening direction and interlocking the first and the second interlocking elements52,54when moved in a closing direction. In some embodiments the interlocking assembly50includes a tongue and groove closure, similar to that found on ZIPLOC™ storage bags. In other embodiments, the interlocking assembly may be in the form of a zipper configuration, sometimes referred to herein, in embodiments, as a zipper assembly.

In embodiments, the mouth42of the specimen bag40has pull strings60,62attached thereto, as well as resilient fingers30,32attached thereto. In other embodiments, the resilient fingers30,32and the pull strings60,62may be received in a cuff (not shown) formed at the mouth42of the specimen bag40. The cuff may be formed on the specimen bag40by any suitable method. In embodiments, for example, a top portion of the specimen bag40may be folded into an interior thereof or onto an exterior thereof and, subsequently, glued thereto to form the cuff.

Referring toFIGS. 2-5, the inner shaft22includes two channels23a,23b(FIG. 3) allowing for passage of the pull strings60,62(FIGS. 2 and 3), or similar devices through or along the inner shaft22. The pull strings60,62are attached to the slider56(FIG. 2) of the interlocking assembly50. The pull strings60,62pass from the slider56through the channels23a,23bon the inner shaft22and pass through the actuation handle25that remains outside the body. In alternate embodiments, a single pull string (not shown) may pass through a single channel (not shown) of the inner shaft22and be attached to the slider56. Where the specimen retrieval device10includes the pull strings60,62to close the interlocking assembly50, the slider56is positioned at a distal location upon deployment of the specimen bag40into a patient.

As depicted inFIG. 3, the specimen bag40may be furled about a distal portion of the inner shaft22for insertion into the longitudinal bore14of the tubular body12. More specifically, the inner shaft22may be rotated either clockwise or counter-clockwise prior to the inner shaft22being introduced into the tubular body12, so that the specimen bag40is furled about the support member28at the distal portion26of the inner shaft22. Thereafter, the specimen bag40can be introduced into the longitudinal bore14of the tubular body12. The specimen retrieval device10is then ready to be introduced into a patient.FIG. 3shows the furled specimen bag40prior to insertion into the tubular body12.

FIG. 5is a cross-sectional view of the specimen retrieval device10of the present disclosure, showing the inner shaft22within the longitudinal bore14of the tubular body12at the distal portion of the hand grip15. Both the hand grip15of the tubular body12and the actuation handle25of the inner shaft22are visible.FIG. 5shows the inner shaft22positioned within the longitudinal bore14of the tubular body12, as well as pull strings60,62within hand grip15.

In use, the tubular body12of the specimen retrieval device10can be inserted through an incision (not shown) with the specimen bag40furled about the inner shaft22and positioned within the tubular body12to position the specimen bag40in a body cavity adjacent a surgical site. When the tubular body12is properly positioned, the clinician can grip the hand grip15.

Turning toFIGS. 1 and 6, the clinician then pushes the actuation handle25on the proximal portion24of the inner shaft22distally in relation to the hand grip15and the tubular body12, in the direction indicated by arrow “A” inFIG. 1, so the distal portion26of the inner shaft22, including the specimen bag40, exits the distal portion18of the tubular body12. Once the specimen bag40has exited the tubular body12, the resilient fingers30,32(FIG. 4) return to their non-deformed state, thereby opening the mouth42of the specimen bag40to ensure the specimen bag40is deployed.

As shown inFIGS. 1 and 6, when the specimen bag40is unfurled, the resilient fingers30,32, return to their non-deformed state to open the mouth42of the specimen bag40so that the specimen bag40is in a fully deployed position capable of receiving a tissue specimen “TS” (FIG. 6) therein.

As depicted inFIGS. 6 and 7, after a tissue specimen “TS” has been placed in the specimen bag40, the pull strings60,62are pulled proximally (indicated by arrow “B” inFIG. 6) to pull the pull strings60,62proximally, thus pulling the slider56proximally (indicated by arrow “C” inFIG. 7) and thereby joining the interlocking elements52,54of the interlocking assembly50. The joining of the interlocking elements52,54of the interlocking assembly50closes the mouth42of the specimen bag40. In some embodiments, a pull ring (not shown) may be affixed to the proximal portion of the pull strings60,62and used to assist in pulling the pull strings60,62.

Kits of the present disclosure may include both the specimen retrieval device described above, as well as trocars, graspers, vacuum sources (tubes), combinations thereof, and the like. In some embodiments, these additional devices, such as graspers and/or vacuum sources, may be used to break up the tissue specimen in the specimen bag prior to removing the specimen retrieval device from the body cavity.

Once the specimen retrieval device of the present disclosure has been removed from the patient's body, any tissue specimen “TS” may be removed from the specimen bag40for further examination and the specimen bag40may be discarded.

While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Additionally, it is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the present disclosure, and that such modifications and variations are also intended to be included within the scope of the present disclosure. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.