WO2016100810A2

WO2016100810A2 - Extractor device for specimen retrieval bag, method of use, method of treatment, and kit

Info

Publication number: WO2016100810A2
Application number: PCT/US2015/066659
Authority: WO
Inventors: Sundaram Ravikumar; Guy Osborne; Henry Allan ALWARD
Original assignee: Beacon Surgical Instruments, Llc
Priority date: 2014-12-18
Filing date: 2015-12-18
Publication date: 2016-06-23
Also published as: WO2016100810A3

Abstract

The invention is directed to an extractor device including a hollow housing and jaws capable of movement in an open position and closed position for grasping and securing a filled specimen retrieval bag.

Description

EXTRACTOR DEVICE FOR SPECIMEN RETRIEVAL BAG, METHOD OF USE, METHOD OF TREATMENT, AND KIT

RELATED APPLICATIONS

[0001] This application claims priority from provisional application Serial No. 62/093,951 filed December 18, 2014.

FIELD OF THE INVENTION [0002] The present invention relates to an extractor device which can be used with a specimen retrieval bag, its method of use, a method of surgical treatment and a kit containing such device.

BACKGROUND OF THE INVENTION

[0003] In general, laparoscopic surgery is a minimally invasive surgical technique, in which surgery is performed through several small incisions rather than the traditional larger incision. This technique relies on the use of endoscopes and long-handled instruments that are introduced into the body through an insertion port, or trocar. As endoscope and instrument technology has improved, the technique has become more and more prevalent and has been adapted to virtually every imaginable procedure. Today, laparoscopic surgery is one of the most common surgical techniques in the United States.

[0004] The initial opening in the body tissue to allow passage of surgical instruments to the interior of the body may be a natural passageway of the body, or it can be created by a tissue piercing instrument such as a trocar, or created by a small incision into which a cannula is inserted. Because the tubes, instrumentation, and any required punctures or incisions are relatively small, the surgery is less invasive as compared to conventional surgical procedures in which the surgeon is required to cut open large areas of body tissue. Therefore, minimally invasive surgery minimizes trauma to the patient and reduces patient recovery time and hospital costs. In addition, in certain surgeries abdominal walls and abdominal organs are minimally damaged during a surgical operation, so that complications, recovery time of a patient and pain during the recovery of the patient can all be reduced.

[0005] Minimally invasive procedures may be used for partial or total removal of body tissue or organs from the interior of the body, e.g. nephrectomy, cholecystectomy, lobectomy and other procedures including thoracic, laparoscopic and endoscopic procedures. During such procedures, it is common that a cyst, tumor, or other affected tissue or organ needs to be removed via the access opening in the skin, or through a cannula. Various types of entrapment devices have been disclosed to facilitate this procedure. In many procedures where cancerous tumors are removed, removal of the specimen in an enclosed environment is highly desirable to prevent seeding of cancer cells. Further, in certain types of surgery such as cholecystectomy, an infected or inflamed gallbladder is removed and bile must be contained so as not to contaminate the surgical area. [0006] Many types of laparoscopic surgery involve removal of tissue, and virtually all of these surgeries require the use of a specimen pouch, also called an endoscopic specimen bag or an "endo bag" or a laparoscopic bag or "lap-bag". The bag is inserted into the body via a cannula and trocar, in an incision location where another device has been removed or for example through the belly button, and the bag is deployed to receive the tissue, closed, and then removed through one of the incisions.

[0007] During the abdominal surgery using an endoscope as described above, when an operator performs an operation of removing tumors or suturing internal organs and the like, the operator inserts various medical instruments into an abdomen, together with the endoscope and surgical instruments, to take pieces of tumors or internal organs, which are removed during the abdominal surgery, out of the abdomen by receiving the pieces of tumors or internal organs in a polyurethane bag using a medical instrument referred to as a lap-bag. [0008] Conventional lap-bag mechanisms employed in an abdominal surgery using the trocar as described above are well known and comprise a tube or cannula, a wire spring and a folded vinyl bag. In action the wire spring is engaged and the bag moves over the specimen and a pull string is engaged by a second instrument via a different incision or trocar and the string seals and cinches the bag holding the specimen.

[0009] In certain surgical operations such as abdominal surgery, an incision is made in the abdomen sufficient for insertion of a 10 mm trocar which forms pneumoperitoneum by putting gas (e.g. C02 gas) into the abdomen during endoscopic surgery so as to create the space and visibility for the endoscopic surgery, and allows an endoscope, a surgical instrument and a medical instrument such as an endoloop or lap-bag, to be inserted into the abdomen. The trocar and cannula are used for inserting surgical instruments into the abdomen. Given the diameter of the trocar and the various instruments passing therethrough, the incision must be at least 15-20 mm.

[0010] Conventional minimally invasive surgeries for cholecystectomy involve the use of four trocars (access devices). In general, one trocar is inserted in the umbilicus, through which an endoscope is inserted, with two trocars being inserted on the right side of the abdomen for retraction and mobilizing the gallbladder, in order to identify the important structures. The fourth trocar is typically inserted in the midline above the umbilicus. [0011] The aforementioned method has become the standard approach and has withstood twenty years of changes in surgical skill sets, in various groups of surgeons. Relatively recently, even newer and advantageous techniques for cholecystectomy have been developed that involve either two 5 mm trocars or even only a single trocar or "porT, called SILS (single incision laparoscopic surgery). As most conventional specimen retrieval bag devices are 10 mm they in turn require a 10 mm trocar opening and thus the less invasive two 5 mm trocar method of surgery cannot be used. Further, the prediction is that nearly twenty to forty percent of all gallbladder surgeries will be performed using SILS as the opening and incision is larger than the two trocar method, but the number of openings or incisions is reduced. This technology involves inserting a single port inserted through the umbilicus, with all the instalments going into the abdominal cavity through the single port Retrieving the gallbladder is challenging with this technology, especially if the gallbladder is distended due to inflammation.

[0012] At the end of the surgical procedure, such as in a cholecystectomy, the specimen retrieval bag filled with the organ or tissue, is extracted through the incision, such as the umbilicus, with the specimen retrieval bag bunching in the bottom as the top is pulled through the incision point. The surgeon then must use additional force to pull the bottom of the filled specimen bag through the incision point, which may result in further tearing at the incision point with scarring, post-operative pain and possible infection and complications. In certain cases the specimen retrieval bag may tear under such pressure and force being pulled through the incision point resulting in

contamination within the body cavity of cancerous, bilious or infected tissue. In order to deal with the larger bunched bottom of the specimen retrieval bag the surgeon may instead extend the incision point with additional small cuts or incisions thereby increasing the opening of the incision point again resulting in additional scarring, postoperative pain, longer recuperation, and possible infection and complications. Notably, as the incision point is increased the advantages of a laparoscopic surgery are reduced. Further, the increased time in pulling the specimen bag through the incision point, increasing the size of the incision point through additional incisions, and/or the follow up after a specimen retrieval bag bursts and the contaminated body cavity is cleaned, results in longer surgical time, increased costs, and increased risk of complications to the patient. Thus a need exists for a device or instrument which can assist in extraction of a filled specimen retrieval bag through the incision point or incision port. A further need exists for a device or instrument which can compress and reduce the size of the filled specimen retrieval bag.

(0013] Moreover, the movement of the filled specimen retrieval bag is typically only controlled by the string which cinches the specimen retrieval bag containing the organ or tissue. The surgeon cannot use conventional graspers as they may nick, cut or pierce the filled specimen retrieval bag thereby contaminating the body cavity, such as when the filled specimen bag contains a tumor or other diseased tissue or organ or other contaminant Thus a need exists for a grasping device which can employ control of movement over the filled specimen retrieval bag. A further need exists for a grasping device which can employ movement of the filled specimen bag without puncturing the filled specimen retrieval bag. A further needs exists for a device which is configured to be able to squeeze or compress the tissue within the filled specimen retrieval bag into a small diameter cylindrical shape for easier removal through a small incision port or point as opposed to conventional devices and methods wherein the tissue compresses into a larger diameter spherical shape within the specimen retrieval bag. [0014] This and other needs are met by the inventive specimen removal device. The number of incisions, namely larger incisions needed for a 10 mm trocar, are reduced. In addition, an operation process for removing the specimen can be simplified by using the inventive extractor device with a specimen retrieval device and the time and cost for the surgery can be reduced. Likewise the potential for complications and pain to the patient post-surgery may be reduced by the inventive extractor device.

[0015] Accordingly, there remains a need in the art for the inventive extracting and grasping device which may be used with a specimen retrieval device, its method of use, a method of treatment, and a kit containing the inventive device. The present invention provides a solution for these needs and other needs. [0016] The present invention has been made to solve the above problems occurring in the prior art and other needs in regard to surgical instruments and methods of treatment.

SUMMARY OF THE INVENTION

[0017] In one aspect, a surgical instrument for laparoscopic procedures is provided, which is adapted and configured to be self-inserted and retrieve a specimen via an endoscopic bag with an extractor. [0018] In another aspect, a kit for laparoscopic procedures is provided including a device which is adapted and configured to be self-inserted and retrieve a specimen via an endoscopic bag with an extractor.

[0019] In yet another aspect, a method for laparoscopic procedures is provided including use of a surgical instrument for laparoscopic procedures, which is adapted and configured to be self-inserted and retrieve a specimen via an endoscopic bag with an extractor.

DESCRIPTION OF THE DRAWINGS

[0020] The above and other advantages of the present invention will become readily apparent with reference to the following detailed description when considered in conjunction with the accompanying drawings which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the devices and related methods of the invention. Together with the description, the drawings serve to explain the principles of the invention, wherein: [0021] FIGURE 1 is a side view illustrating one embodiment of the inventive extractor device in a closed position.

[0022] FIGURE 2 is a perspective view illustrating one embodiment of the inventive extractor device in an open position.

[0023] FIGURE 3 is a perspective view of one embodiment of the inventive extractor device looking from the top view near the knob with the jaws in a closed position.

[0024] FIGURE 4 is a perspective view of another embodiment of the inventor extractor device in a closed position over a specimen retrieval device with the specimen retrieval bag retracted in an inactivated position.

[0025] FIGURE 5 is a top view of an embodiment of the inventive extractor device showing text of the knob movement positions. [0026] FIGURE 6 is an exploded view of where the jaws, in an open position, are connected to the housing of the inventive extractor device.

[0027] FIGURE 7 is an internal exploded view of where the jaws, in a closed position, are connected to the housing of the inventive extractor device. [0028] FIGURE 8 is a perspective view of another embodiment of the inventive extractor device in a closed position.

[0029] FIGURE 9 is a different perspective view of another embodiment of the inventive extractor device in an open position.

[0030] FIGURE 10 is a side view of another embodiment of the inventive extractor device in an open position.

[0031] FIGURE 11 is an internal view of another embodiment of the inventive extractor device in a closed position.

[0032] FIGURE 12 is a side view of one embodiment of the inventive extractor device in use partially inserted within the fascia of a patient in a body cavity, with the inventive extractor device in a closed position, over a specimen retrieval device with the specimen retrieval bag retracted in an inactivated position.

[0033] FIGURE 13 Is a side view of another embodiment of the inventive extractor device in use partially inserted within the fascia of a patient in a body cavity, with the inventive extractor device in a closed position, over a specimen retrieval device with the specimen retrieval bag open in an activated position awaiting a specimen to be placed within the open specimen retrieval bag.

[0034] FIGURE 14 is a side view of one embodiment of the inventive device side view of one embodiment of the inventive device in use partially inserted within the fascia of a patient in a body cavity, with the inventive device in a closed position grasping a filled specimen retrieval bag within a body cavity. [0035] FIGURE 15 is a side view of another embodiment of the inventive extractor device side view of one embodiment of the inventive extractor device in use partially inserted within the fascia of a patient in a body cavity, with the inventive extractor device in a closed position grasping a filled specimen retrieval bag within a body cavity. DETAILED DESCRIPTION OF THE INVENTION

[0036] Reference will now be made in detail to the present invention, examples of which are illustrated in the accompanying drawings.

[0037] In accordance with one aspect of the invention, a surgical instrument device is provided which is an extractor device having the capacity to move and/or assist in extracting a filled specimen retrieval bag or having other uses. The extractor device includes at least two jaws which are capable of moving from a closed position to an open position, as well as the reverse and back over again, and which can grasp and compress a filled specimen retrieval bag or other objects. When the jaws are in a closed position and for example, the filled specimen retrieval bag is compressed, the extractor device further assists in easing the extraction of the filled specimen retrieval bag through an incision point. The extractor device is configured to have a hollow center and capable of being inserted over a conventional specimen retrieval device. These and other uses of the extractor device will be discussed below.

[0038] It should be noted that although the device of the present invention is

advantageous for surgical procedures such as cholecystectomy procedures, it can advantageously be applied to retrieve and/or extract filled specimen retrieval bags in other procedures containing other organs, such as the urinary bladder, for example, and to retrieve tissue such as tumors.

[0039] For the purposes of explanation and illustration. and not limitation, in

accordance with the invention, an exemplary embodiment of a specimen retrieval device is illustrated in FIGURES 1 , 2 and 3. In accordance with these examples, the extractor device 100, as shown in FIGURES 1 and 3 in a closed position, is comprised of a hollow tube 110 connected to a handle 140 on a middle portion proximal end and at least two jaws 121, 123 on the distal end. The handle 140 includes an activation means which moves the two jaws 121, 123, from a dosed position to an open position and the reverse. The positions (open and closed) may be repeated and reversed over and over again. In one embodiment the activation means includes a knob 150 on the proximal end of the hollow housing 110, which knob 150 has a rotational movement in order to move the jaws 121, 123 from a closed position into an open position as well as from an open position to a closed position, such closing movement of the jaws 121 , 123 employed to grasp and/or compress a filled specimen retrieval bag. Other activation means may be employed other than a knob such as a latch, rod and other known activation means. In order to reduce any inadvertent trauma to tissue and organs when the extractor device 100 is within a body cavity in use, a hinge cover 130 is employed to cover the middle section of the jaws 121, 123 as such middle section of the jaws 121, 123 may include tabs capable of harming the patient when within a body cavity.

[0040] The tube 110 (or cannula) of the extractor device 100 is preferably hollow and may have a diameter of about 3 mm to about 20 mm, preferably slightly larger than the outer diameter of the tube or cannula of a specimen retrieval device (200 as shown in FIGURES 4, 12 and 13) if the extractor device 100 is placed on the outside of such specimen retrieval device 200 when in use. The tube 110 (or cannula) of the extractor device may have length of about 200 mm, in a range of about 50 mm to about 400 mm. The length of the tube 110 may vary depending the patient, pediatric versus obese adult, and the location of the body cavity in which the extractor device 100 will be inserted and used.

[0041] The tube 110 (or cannula) of the extractor device 100 may be comprised of any material compatible with the human body as a portion of it will be within the body cavity when in use. The tube 110 is preferably comprised of a metal such as stainless steel and is preferably coated with a shrink wrap plastic such as shrinkable polyester, polyolefin, polyethylene, or polyvinyl chloride of a grade suitable for use in surgical procedures. The dimensions of the tube 110 may also be such that the diameter is slightly larger than the maximum diameter of the specimen retrieval bag (shown deployed in FIGURE 13), either empty or filled and preferably when filled with the target specimen, such as for example in a range of between about 1 mm to about 50 mm.

[0042] The jaws of the extractor device 100 are used, in one embodiment, to grasp, move and extract the filled specimen retrieval bag from within the body cavity. At least two jaws are needed, preferably three jaws, though any number of jaws may be employed including four or more. Two jaws are visible in FIGURES 1 and 3 with a third not visible as the extractor device 100 is in the closed position. In FIGURE 2 the extractor device 100 is in the open position and three jaws 121, 123, 125 are shown. The jaws 121, 123, 125 may be made of any material compatible with the human body as a portion of it will be within the body cavity when in use. Such materials may include polymers, plastics, metals, and the like. It is preferable that the jaws 121, 123, 125 are made of metal such as stainless steel or even titanium. The jaws 121 , 123, 125 have a length of about 10 mm to about 1500 mm, preferably from about 50 mm to about 500 mm. The length may depend on the size of the patient, the target organ in the surgery and the approximate length and width of the filled specimen retrieval bag to be grasped and extracted when in use. Again, other uses for the jaws (121, 123 and 125) and the extractor device 100 may be employed beyond grasping a specimen retrieval bag and/or extracting a filled specimen retrieval bag such as facilitating surgical procedures.

[0043] The jaws 121, 123, 125 may be one piece each with a slight convex shape, such as to grasp the filled specimen retrieval bag. Other embodiments of the jaws are angled such that the distal portion of the jaws 121a, 123a, 125a grasp the filled specimen bag. In yet another embodiment not shown, the jaws 121, 123, 125 are comprised of two separate pieces connected so that the distal piece (121a, 123a, 125a) has an angle or curve which assists in grasping the filled specimen bag. As shown in one embodiment of the present invention, the jaws 121, 123, 125 of FIGURES 1 through 4 are tapered and narrowing at the distal end of the jaws 121a, 123a, 125a. Further as shown in FIGURES 1 through 4, the jaws 121, 123, 125 have a convex shape on the longitudinal axis and have a slight angle or convex shape on a lower portion of the distal end of the jaws 121a, 123a, 125a. In use, the jaws 121, 123, 125 are open and placed over a portion of the filled specimen retrieval bag and then the jaws 121, 123, 125 are forced closed so as to grasp the filled specimen retrieval bag. The camber of the jaws 121, 123, 125 in use grasps the filled specimen retrieval bag, compresses and secures it during extraction from the body cavity.

[0044] The jaws 121, 123, 125 in one embodiment are comprised of one piece of metal with three different portions with a distal end (121a, 123a, 125a), a second middle portion 121b, 123b, 125b extending out of the tube 110 beneath the hinge cover 130, and one hidden proximal end 121c, 123c, 125c within the tube 110, where the configuration still allows the jaws 121, 123, 125 to be capable of movement from the closed position to the open position and movement from the open position to the closed position. In another embodiment of the present invention each of the jaws are each comprised of one piece of metal with three different portions with a distal end (121a, 123a, 125a), a second middle portion 121b, 123b, 125b extending out of the tube 110 beneath the hinge cover 130 which is connected to the tube 110 via a variety of mechanism such as hinges, bolts, screws, soldering and any other means to connect materials with, and one hidden proximal end 121c, 123c, 125c within the tube 110, where the connection still allows the jaws 121, 123, 125 to be capable of movement from the closed position to the open position and movement from the open position to the closed position. In other embodiment of the inventive device each of the jaws 121 , 123, 125 are comprised of one piece of metal with two different portions with a distal end (121a, 123a, 125a), and a second middle portion 121b, 123b, 125b which is connected within the tube 110 via a variety of mechanism such as hinges, bolts, screws, soldering and any other means to connect materials, such jaws 121, 123, 125 being connected to an activation means such as a latch, rod or other activation means while still allowing the jaws 121, 123, 125 to be capable of movement from the closed position to the open position and movement from the open position to the closed position.

[0045] FIGURES 6 and 7 show one embodiment of the present invention wherein each of the jaws 121, 123, 125 are comprised of one piece of metal with three different sections. The distal ends 121a, 123a, 125a are tapered downward and with the middle portion 121b, 123b, 125b extend out of the hollow tube 110. The proximal portion 121c, 123c, 125c is hidden from view within the hollow tube 110. At the juncture of the middle portion 121b, 123b, 125b and the proximal portion 121c, 123c, 125c is a flexible portion 121d, 123d, 125d. The flexible portion 121d, 123d, 125d is created in one embodiment during manufacture of the jaws 121, 123, 125 wherein the coining increases the temper and creates a spring-like steel portion which is thinner and more narrow that the middle portion 121b, 123b, 125b thus making it a flexible portion 121d, 123d, 125d. This flexible portion 121d, 123d, 125d in one embodiment of the present invention is included in the activation means along with, for instance, an activation trigger such as a hub 170 shown in FIGURE 11. The hub 170 in this embodiment of the present invention includes a slot (not shown) into which a proximal tab 121e, 123·, 125e fits and is connected. The proximal tabs 121·, 123·, 125· are located at the proximal end of each of the Jaws 121, 123, 125 and in this embodiment face in a direction opposite of the tapered distal ends 121a, 123a, 125a. When the activation means is activated the hub 170 is for instance pushed forward in a longitudal direction as shown in FIGURE 11 (which would be vertically down when in use such as in FIGURES 14 and 15) thus pushing the connected proximal tabs 121·, 123·, 125· forward in a the same direction resulting in a force on the jaws 121, 123, 125 which is resisted by the tube 110 and creates torque at the flexible portion 121d, 123d, 125d and forces the distal ends 121a, 123a, 125a open in an open position. When the hub 170 is retracted into a resting or closed position the proximal tabs 121·, 123·, 125· are likewise retracted into a resting or closed position release the force and torque and thus the distal ends 121a, 123a, 125a are closed. The opening and closing states may be repeated and reversed as need by the user during a surgical procedure. Other activation means or spring bias or opening and closing means may be employed in the inventive extractor device 100 such as without limitation a spring, nut and bolt, screw, hinge or the like or any combination thereof.

[0046] The jaws 121, 123, 125 of one embodiment of the present invention further include a connecting means on the proximal end of the middle portion 121b, 123b, 125b for connection to the hollow tube 110. In one embodiment of the present invention the connecting means are one or more tabs. As shown in FIGURES 5 and 6, in one embodiment of the present invention of the jaws, two middle portion tabs 121f, 121g extend in a direction opposite the tapered distal end 121a and in the same direction as the proximal tab 121·. The middle portion tabs 121f, 121g are inserted into an opening, aperture, slot or the like within the interior of the hollow tube 110. The middle portion tabs 121f, 121g thus may comprise part of the activation means in that the jaw 121 has a force against the hollow tube 110 when the hub 170 and connected proximal tab 121 e are activated and moved from a dosed position into an open position, typically by pushing the hub 170 forward. As the middle portion tabs 121f, 121g are inserted into the distal end of the tube 110 and could nick or otherwise harm the patient when the inventive extractor device 100 is in use, an optional hinge cover 130 may be employed. The hinge cover 130 may be comprised of a material compatible with the human body such as a polymer, plastic, metal or other materials, preferably an elastomer. The hinge cover 130 protects the body cavity from inadvertent nicks or cuts from the tabs.

[0047] In another embodiment of the present invention each of the jaws 121, 123, 125 are comprised of two portions, namely the distal ends 121a, 123a, 125a and the middle portion 121b, 123b, 125b. In this embodiment, the middle portion is connected to a flexible beam or rod or other known component with is capable of activating the jaws 121, 123, 125. The flexible portion, whether it is a beam or rod or other configuration or component, may be connected to the jaws 121, 123, 125 via a connecting means such as a hinge mechanism such as including a plurality, preferably two, of tabs or hinges, crimps, screws or other known connecting means.

[0048] The inventive extractor device 100 further includes a handle 140 and an activation means such as a knob 150. The knob 150 is shown in detail in FIGURE 5 wherein the opening aperture 155 is open for the insertion of a specimen retrieval device or open for pulling of the connected to the specimen retrieval bag and then extraction of the filled specimen retrieval bag. In one embodiment of the present invention as shown in FIGURE 4 the extractor device 100 is inserted over the cannula or housing tube 210 of the specimen retrieval device 200 via this aperture 155 on the knob 150. [0049] In use, the knob 150 is rotated and drives each of the jaws 121, 123. 125 forward through the relative flexible portion 121d, 123d, 125d. The force from the relative flexible portion 121d, 123d, 125d is resisted by each of the tabs 121f, 121g, 123f, 123g, 125f, 125g creating a torsional force which flexes the flexible portions 121d, 123d, 125d and drives each of the Jaws 121, 123, 125 open and moved to an open position. In reverse when the knob 150 is rotated in the opposite direction the jaws 121, 123, 125 are closed and moved to a closed position by release of the force on the relative flexible portion 121d, 123d, 125d. In one embodiment the flexible portion may be a beam. Other opening and closing mechanism may be employed as known in the art.

[0050] In one embodiment of the present invention one of the jaws may include a portion to widen the incision area such as a blunt shape or a blade 127. The blade 127 is used to widen the incision area on the patient's fascia when the filled specimen retrieval bag is larger than the incision area. The blade 127 may also provide a visual cue for the user of a point of the distal end of the inventive extractor device 100. In another embodiment, as shown in FIGURES 8-11 , the blade 127 is lined up with a notch 141b in a base grip 141a of the handle 140. The base grip 141a includes one 142a or two thumb or finger grips 143a, 143b to assist in tactile movement of the inventive extractor device 100 during use. The handle 140 may further include a series of indentations 140a for further tactile feeling by the user. The handle 140 in this embodiment includes a knob 150 without any text regarding an opening or closing direction. In one embodiment of the inventive extractor device 100 as shown in

FIGURE 11 , the internal components include a hub 170 which forces the proximal tabs 121e, 123·, 125e so as to force the jaws 121, 123, 125 from a dosed position into an open position, with a reversed release of force so that the jaws 121, 123, 125 are then closed from the open position.

[0051] A method of use of the inventive extractor device 100 includes the initial step of placing the extractor device 100 on a specimen retrieval device 200 via insertion of the specimen retrieval device 200 through the aperture 155 in the knob 150. The specimen retrieval device 200 includes a housing 210 (such as a hollow tube) having a

14 housing grip 260. The housing 210 is connected to a push rod 240 which includes a loop mechanism 250 on the push rod's 240 proximal end. Within the housing 210 at the distal end of the specimen retrieval device 200 is the non-activated or non-deployed specimen retrieval bag 300 (not shown in FIGURE 12). The specimen retrieval bag 300 includes a string 220 on the upper portion which string 220 extends through the housing 210, within a channel in the push rod 240 and loop mechanism 250 and out of the loop mechanism 250.

[0052] The next step of the inventive method is positioning the specimen retrieval device 200, including the extractor device 100 on the outside of the tube 210 of the specimen retrieval device 200, outside of the body directly over or in the vicinity of the tissue or organ to be retrieved. Force is applied such that the distal end tip 230 of the specimen retrieval device 200 penetrates the fascia 500 of the patient. No trocar is needed to insert the specimen retrieval device 200. Once within the body and fascia 500, the distal end tip 230 of the specimen retrieval device 200 is positioned in proximity to the tissue or organ to be retrieved, and the specimen retrieval bag 300 is deployed, as shown in FIGURE 13. Deployment of the specimen retrieval bag 300 is based on a mechanism located opposite the distal end tip 230 of the specimen retrieval device 200. Specimen retrieval bag 300 deployment mechanisms include but are not limited to a push rod 240 connected to for instance a loop grip mechanism (250), pistol grip mechanism, a twist mechanism, a spring mechanism, a push/pull mechanism, or combinations thereof. As shown in FIGURES 12 and 13, the loop mechanism 250 is pushed in a downward direction such that the push rod 240, which was extended above the housing grip 260, is pushed into the housing pushing out the specimen retrieval bag 300 from a distal end of the housing 210. The deployed specimen retrieval bag 300 is moved so as to encompass the target tissue or organ 400 within the specimen retrieval bag. In one embodiment of the inventive method, the filled specimen retrieval bag 300 is detached from specimen retrieval device 200 except for the string 220 cinching the upper portion of the filled specimen retrieval bag 300. The specimen retrieval device 200 is then partially retracted from the body cavity and fascia 500 so that the filled specimen retrieval bag 300 remains in the body cavity, the string 220 has an end remaining outside the body and fascia 500, and the inventive extractor device 100 is partially within the body and fascia 500. The filled specimen retrieval bag 300 is pulled, via the string 220 or moved closer by other surgical instrument within the body cavity via other incisions, in a direction toward the extractor device 100. The extractor device 100 is activated so that the jaws 121, 123, 125 are moved into an open position and grasp the filled specimen retrieval bag 300 and then the jaws 121, 123, 125 are moved into a closed position to stabilize and secure the filled specimen retrieval bag 300. Next the filled specimen retrieval bag 300 is removed along with the inventive extractor device 100 by force to retract the filled specimen retrieval bag 300 and extractor device 100 from the fascia 500. If the filled specimen retrieval bag 300 is larger than the incision area the user can position the blade 127 so as to enlarge the incision area upon retraction and removal of the extractor device 100 and filled specimen retrieval bag 300.

[0053] In another embodiment of the present inventive method of use an optional step is included wherein after the inventive extractor device 100 is activated and the jaws 121, 123, 125 forced into an open and subsequent closing state, a suture is inserted into the housing 110 and looped or placed around the bottom of the filled specimen retrieval bag via one or more clamps, forceps or the like. At this step each of the two ends of the single suture are located outside of the fascia 500 outside of the knob 150 and the middle portion of the single suture is around the diameter of the filled specimen bag 300 in a vertical direction. A single or plurality of clamps, forceps, hemostats or the like are then inserted within the aperture 155 of the knob 150 into the hollow housing 110. The single or plurality of clamps, forceps, hemostats or the like grasp and/or clamp onto the suture on each side of the filled specimen retrieval bag 300 and force is used to pull the filled specimen retrieval bag 300 in an upward direction further into the housing 110. A shorter length housing 110 may be advantageous at this point such that the filled specimen bag 300 may be pulled within the distal end or even the middle or proximal end of the housing 110 depending on the diameter of the housing 110 and the size of the tissue 400 within the filled specimen retrieval bag 300. If the filled specimen retrieval bag 300 is housed within the housing 110 then the jaws 121, 123, 125 have a greater surface area when grasping and compressing the tissue 400 within the filled specimen retrieval bag 300 and should be able to compress the filled specimen retrieval bag 300 into a smaller diameter cylindrical shape tor easier removal through the incision port or point.

[0054] Another aspect of the present invention is a surgical kit which includes the extractor device 100. The kit is stored in a sterile sealed package. The kit may include a trocar, a scissors device, a grasper device, a specimen retrieval device and the extractor device 100. The kit may optionally include a cauterizing device such as a bipolar device. Other optional devices may be included. In one embodiment of the inventive kit all components are single use only and disposable. In another embodiment of the inventive kit some components are single use and disposable while others are reusable (typically after sterilization). In yet another embodiment of the inventive kit the components are reusable (typically after sterilization) except that the bag would be single use only and disposable.

[0055] Advantages of the inventive extractor device 100 include the configuration such that it is easier to remove a filled specimen retrieval bag from the body cavity and fascia of a patient. Accordingly the incision location is smaller and may cause less surgical damage to the fascia, reduce the total operation time required for the procedure and reduce possible complications. Further, the surgical process for removing a specimen can be simplified by using the inventive extractor device 100 and the time and cost for the surgery can be reduced.

[0056] Further, the configuration of the inventive extractor device 100 enables it to squeeze or compress the tissue within the filled specimen retrieval bag into a small diameter cylindrical shape for easier removal through a small incision port or point as opposed to conventional devices and methods wherein the tissue compresses into a larger diameter spherical shape within the specimen retrieval bag. Overall, the extractor device 100 may reduce complications, surgical processes, time and cost.

[0057] Many possible combinations could be within the extractor device, the methods of use, the method of treatment and the kit or system of the present invention. [0058] Although the exemplary embodiments of the present invention have been described, it is understood that the present invention should not be limited to these exemplary embodiments but various changes and modifications can be made by one ordinary skilled in the art within the spirit and scope of the present invention as hereinafter claimed.

[0059] The invention has been described in terms of embodiments thereof, but is more broadly applicable as will be understood by those skilled in the art. The scope of the invention is only limited by the following claims.

Claims

We claim: 1 . A surgical assembly for extracting a specimen retrieval bag, comprising:

a hollow housing;

a plurality of jaws each having two portions wherein a proximal portion is located within the hollow housing and the second portion has a tapered distal end located outside the hollow housing, the jaws each having an exterior with a partial convex shape, the distal portion of the jaws being configured to move toward each other into a closed position and away from each other into an open position;

an activator that is configured to impart a force onto the proximal portion of the jaws to urge open the distal portion of the jaws to reach the open position and that is configured to release the imparted force from the proximal portion of the jaws, which causes the distal portion of the jaws to close and thus move the jaws out of the open position and toward the closed position.

2. The surgical assembly of claim 1 wherein the activator includes a handle, a

rotational knob and a spring bias, wherein the rotational knob is configured to apply the force to the proximal portion of each of the jaws that overcomes the spring bias to urge the distal end of each of the jaws to reach the open position as the rotational knob is rotated in one direction relative to the hollow housing and to release the force to the proximal portion of each of the jaws as the rotational knob is rotated in the opposite direction relative to the hollow housing so that the jaws return under the spring bias to the closed position.

3. The surgical assembly of claim 2, wherein each of the jaws includes a flexible middle portion that provides the spring bias of the activator.

4. The surgical assembly of claim 1. wherein the activator includes a hub movable between a retracted position and an extended position, the hub and the jaws being arranged relative to each other so that as the hub moves between the retracted and extended positions, the distal ends of the jaws move between the closed and open positions in correspondence with each other.

5. The surgical assembly of claim 4, further comprising proximal tabs that extend from the proximal portion of the jaws to engage the hub so as to ensure that the hub and the jaws move in correspondence with each other.

6. The surgical assembly of claim 5, further comprising:

a hinge cover that covers the proximal tabs.

7. The surgical assembly of claim 1 , further comprising a knob that is rotataWe to drive each of the jaws via a flexible portion.

8. The surgical assembly of claim 1 , further comprising:

a blunt tab extending on the exterior of one of the jaws configured to enlarge an incision point upon removal of the surgical assembly from a body cavity.

9. The surgical assembly of claim 8 wherein the blunt tab is a blade.

10. A surgical specimen retrieval assembly comprising:

a surgical assembly for extracting a specimen retrieval bag, comprising: a hollow housing;

a plurality of jaws each having two portions wherein a proximal portion is located within the hollow housing and the second portion has a tapered distal end located outside the hollow housing, the jaws each having an exterior with a partial convex shape, the distal portion of the jaws being configured to move toward each other into a closed position and away from each other into an open position; an activator that is configured to impart a force onto the proximal portion of the jaws to urge open the distal portion of the jaws to reach the open position and that is configured to release the imparted force from the proximal portion of the jaws, which causes the distal portion of the jaws to close and thus move the jaws out of the open position and toward the closed position; and

a specimen bag that is flexible, the specimen bag being compressed by force exerted from the jaws as the jaws move from the open position toward the closed position.

11. The surgical specimen retrieval assembly of claim 10, wherein the specimen bag is partially between the jaws so as to interfere with closing of the jaws so that the jaws are prevented from reaching the closed position due to blockage by the specimen bag.

12. The surgical specimen retrieval assembly of claim 10, further comprising;

a specimen bag that is flexible and a rod that supports the specimen bag, the hollow housing accommodating therein a portion of the rod.

13. The surgical specimen retrieval assembly of claim 10 wherein the activator

includes a handle, a rotational knob and a spring bias, wherein the rotational knob is configured to apply the force to the proximal portion of each of the jaws that overcomes the spring bias to urge the distal end of each of the jaws to reach the open position as the rotational knob is rotated in one direction relative to the hollow housing and to release the force to the proximal portion of each of the jaws as the rotational knob is rotated in the opposite direction relative to the hollow housing so that the jaws return under the spring bias to the closed position.

14. The surgical specimen retrieval assembly of claim 13, wherein each of the jaws includes a flexible middle portion that provides the spring bias of the activator.

15. The surgical specimen retrieval assembly of claim 10, further comprising:

16. The surgical specimen retrieval assembly of claim 15 wherein the blunt tab is a blade.

17. A method of surgical specimen retrieval, comprising the steps of:

positioning an extractor device over a hollow housing on a specimen retrieval device;

sliding a deployment rod on said specimen retrieval device that has a proximal end out of the housing and a distal end within the housing from a retracted position within a hollow of a hollow housing to an extended position to at least partially project out of the hollow housing;

moving at least one of two portions of a flexible support ring between a folded position that fits within the hollow of the housing and an unfolded position clear of the hollow of the housing, moving the flexible support ring, which is connected to the deployment rod, in unison with movement of the deployment rod from the retracted position to the extended position, moving the two portions of the flexible support ring from the folded position to the unfolded position under spring bias as the flexible support ring clears the hollow of the housing and the deployment rod enters the extended position from the retracted position;

moving a specimen bag, which is removably connected to the flexible support ring, from a stowed position within the hollow of the hollow housing to a deployed position fully clear of the hollow housing as the deployment rod moves from the retracted position into the extended position so as to thereby open a mouth of the specimen bag in the deployed position;

placing a specimen within said open mouth of the specimen bag;

cinching said filled specimen bag; activating said extractor device so that a series of jaws on said extractor device are moved into an open position over the upper portion of the cinched filled specimen bag;

moving the jaws of the extractor device toward a closed position over the upper portion of the cinched filled specimen bag;

retracting the specimen retrieval device from the body cavity; and

retracting the cinched filled specimen bag and extractor device from the body cavity.

18. The method of surgical specimen retrieval of claim 17 wherein the extractor device is comprised of:

a hollow housing;

a plurality of jaws each having two portions wherein a proximal portion is located within the hollow housing and the second portion has a tapered distal end located outside the hollow housing, the jaws each having an exterior with a partial convex shape, the distal portion of the jaws being configured to move toward each other into a closed position and away from each other into an open position; and

19. The method of surgical specimen retrieval of claim 17 wherein the activator

20. The method of surgical specimen retrieval of claim 19, wherein each of the jaws includes a flexible middle portion that provides the spring bias of the activator.

21. The method of surgical specimen retrieval of claim 17 further comprising the step of using a blunt tab on the exterior of one of the jaws to enlarge the incision point upon retraction of the extractor device and filled specimen bag.