Abstract:
The invention provides a vacuum mouthpiece ( 2 ) for the acquisition and retention of resected biological specimens for retrieval from a body cavity, the mouthpiece being attached to a first tubular member ( 4 ) connectable to a vacuum source and having an active surface including at least one opening communicating with the first tubular member; the mouthpiece ( 2 ) being made of an elastically resilient material and having, in a free state, an outside diameter larger than the inside diameter of a second tubular member ( 24 ) into which it is insertible by elastic deformation. The invention further provides a closable pouch ( 20 ) for the entrapment and retrieval of a resected biological specimen from a body cavity, and a laparoscopic system and method utilizing the above.

Description:
FIELD OF THE INVENTION 
     The present invention relates to an apparatus and method for acquisition and retrieval of resected biological specimens. More specifically, the present invention is concerned with a vacuum mouthpiece for the acquisition and retrieval of resected biological specimens from a body cavity, a self-closing pouch for entrapment and retrieval of resected biological specimens from a body cavity, and a laparoscopic system incorporating such a mouthpiece and such a pouch. 
     BACKGROUND OF THE INVENTION 
     Laparoscopy, also known as “keyhole surgery,” is today increasingly complementing and even replacing conventional surgery, especially in the abdominal region, for resection and removal of diseased organs such as a gall bladder, ovaries, or diseased parts of such organs, cysts, and the like. The small incisions required for laparoscopic procedures minimize skin scarring, reduce the risk of infection, and greatly speed up would healing. 
     Laparoscopic devices for the removal of resected specimens are known, most of which are based on the use of a pouch and propose ways of closing that pouch with the specimen inside it, such as a drawstring thread (U.S. Pat. Nos. 5,647,372 and 5,465,731) as well as grasping means to control the pouch edges, but do not address the cardinal issue of getting hold of the resected specimen, putting it into the pouch, and withdrawing it from the body cavity. 
     U.S. Pat. No. 5,480,404 teaches a belt-like loop with a flexible pouch which enables the scooping up of the specimen, closing the pouch and removing it from the body cavity. This disclosure too, only partially resolves the issue of “catching” the specimen, and does not deal satisfactorily with the withdrawal of the specimen from the body cavity. 
     Instead of a pouch, U.S. Pat. No. 5,176,687 uses a flexible membrane which has a collapsed and an expanded state, but it does not deal with the retrieval of the specimen. 
     U.S. Pat. No. 5,215,521 discloses an envelope sheath to entrap the resected specimen as well as a morcellator allowing for safe morcellation of the specimen, and provides both for the catching and the retrieval thereof, but the apparatus and auxiliaries described are highly complex and require the services of two experienced laparoscopists. 
     U.S. Pat. No. 5,279,548 teaches a method for use in a peritoneal or pelvis surgery, in which a funnel-like membrane introduced into the body cavity is positioned vertically below the organ to be resected, allowing the resected tissue to fall into the membrane. 
     WO 97/17021 discloses a device for retrieving tubular parts such as stents from blood vessels. The gripping members of the device are provided with hooked ends adapted for engaging the stent. 
     U.S. Pat. No. 5,196,003 teaches a surgical instrument for endoscopic surgery having an elastically deformable suction cup communicating with a rubber bulb, whereby a suction effect can be applied to retain resected tissues. 
     WO 97/26828 discloses a laparoscopic instrument for handling parencynmatous and cavum organs. The device is provided with a funnel-like suction cup tiltably articulated to a tubular member and serving to retrieve resected tissue. The assembly is a single unit, and the suction cup cannot be moved independently of the retrieval member. 
     U.S. Pat. No. 5,417,697 teaches a polyp retrieval assembly comprising a cauterizing loop and a cup-shaped web member for retrieving resected tissue. The assembly is a single unit, and the web member cannot be moved independently of the retrieval member. 
     It is thus one of the objects of the present invention to provide a mouthpiece introducible into a body cavity for acquisition and retention of a resected biological specimen by vacuum suction. 
     It is a further object of the present invention to provide a pouch that is self-closing after being introduced into a body cavity, thereby entrapping a resected biological specimen for retrieval. 
     It is yet another object of the present invention to provide a relatively simple laparoscopic device that facilitates the vacuum capture and retention of a resected biological specimen, its entrapment in a self-closing pouch and its retrieval, and that can be operated by a single surgeon with no more than moderate experience in laparoscopy. 
     According to the invention, there is therefore provided a device for the acquisition and retention of resected biological specimens for retrieval from a body cavity, said device comprising a bowl-shaped mouthpiece made of an elastically resilient material; a first tubular member having a distal end connected to said mouthpiece and a proximal end connectable to a vacuum pump; characterized in that a plurality of openings are distributed over said mouthpiece, said openings leading to the distal end of said first tubular member, thereby facilitating the retention and retrieval of resected biological specimens by vacuum suction. 
     The invention also provides a closable pouch for the entrapment and retrieval of a resected biological specimen from a body cavity, said pouch comprising pliable, pre-shaped, membranous material attached at selected points substantially along meridian lines, to a plurality of pre-shaped, finger-like elements, said elements having distal ends and proximal ends, the proximal ends of said finger-like elements being connected to a tubular member slidably located inside an outer tubular member, characterized in that said finger-like elements exhibit different responses in different states, a first state response in which the distal ends of said finger-like elements flex away from each other, thereby causing the pouch to open and to engulf and entrap said specimen, and a second state response in which the distal ends of said finger-like elements flex toward each other, thereby causing the pouch to close, thereby retaining said specimen for retrieval. 
     The invention further provides a laparoscopic system for acquisition and retrieval of resected biological specimens, said system comprising at least three telescoping tubular members having distal and proximal ends, including an outer tubular member, an inner tubular member defining with said outer tubular member an annular space and being connectable at its proximal end to vacuum-producing means, and an intermediate tubular member slidably fitting said outer tubular member; a bowl-like mouthpiece having a front face and a rear face, for capturing and retaining a resected specimen, said mouthpiece being connected at its rear face to the distal end of said inner tubular member and being made of an elastically resilient material, said mouthpiece having a diameter in a non-deformed state exceeding the inside diameter of said outer tubular member but fitting into the distal end of said outer tubular member by elastic deformation; a plurality of finger-like elements fixedly connected to the distal end of said intermediate tubular member; a pouch made of pliable, membraneous material fixedly attached at a plurality of points to said plurality of finger-like elements; characterized in that, in the non-active, telescoped state of said system, said pouch, connected to said plurality of finger-like elements, is collapsed and disposed inside said annular space behind the rear face of said mouthpiece, and in the active state of said system, when said intermediate tubular member is pushed out of the outer tubular member, the distal ends of said finger-like elements first flex away from each other, thereby causing the pouch to open and to engulf said mouthpiece, and thereafter, the distal ends of said finger-like elements flex toward each other, thereby causing the pouch to close, entrapping and retaining said specimen for retrieval. 
     The invention still further provides a method for acquisition and retrieval of resected biological specimens, using the laparoscopic system described above, the method comprising the steps of introducing the distal end of the telescoped device into the body cavity; pushing out the inner tubular member, thereby removing the mouthpiece from the outer tubular member and causing said mouthpiece to assume its full diameter; actuating the vacuum-producing means and moving mouthpiece to a location in close proximity to the specimen to be resected, causing the resected specimen to cling to said mouthpiece; pushing out the intermediate tubular member, thereby causing the distal ends of finger-like elements to emerge from the annular space between the outer tubular member and the inner tubular member, said finger-like elements carrying along and opening up the pouch attached to them for engulfing the specimen retained by said mouthpiece; allowing the distal ends of said finger-like elements to close over said mouthpiece, thereby closing the pouch over said specimen, and withdrawing the device from the body cavity. 
     The invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures so that it may be more fully understood. 
     With specific reference now to the figures in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an enlarged, cross-sectional view of a first embodiment of the vacuum mouthpiece according to the invention in its free state; 
     FIG. 2 is a similar view of the embodiment of FIG. 1 when elastically deformed to fit the tubular member; 
     FIG. 3 is an enlarged cross-sectional view of a substantially hollow embodiment of the vacuum mouthpiece according to the present invention; 
     FIG. 4 is a perspective view of the open pouch; 
     FIG. 5 is a perspective view of the closed pouch; 
     FIG. 6 is a top view showing a tubular member accommodating the finger-like elements and the folded pouch prior to their use; 
     FIG. 7 is an enlarged, partial cross-section of the laparoscopic system according to the present invention in its non-active, fully telescoped state; 
     FIG. 8 is a more enlarged view in cross-section along plane XIII—XIII of the system of FIG. 7; 
     FIG. 9 schematically illustrates the flaring open of the finger-like elements and the resulting opening of the pouch; 
     FIG. 10 schematically illustrates the inward flexing of the finger-like elements and the resulting closure of the pouch; and 
     FIG. 11 shows a morcellator used for the fragmentation and liquefaction of solid specimens. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     Referring now to the drawings, there is seen in FIG. 1 a first embodiment of a vacuum mouthpiece  2  according to the invention in its fully expanded state. Mouthpiece  2  is attached, e.g., by adhesive bonding, to a first tubular member  4  connectable to a vacuum pump (not shown). Mouthpiece  2  has a bowl-like shape and is made of an elastically resilient material such as synthetic rubber or the like. Active surface  6  is concave and is provided with a plurality of openings  8  which, via ducts  10 , communicate with a first tubular member  4 . Also seen is a second tubular member  24  into which, as shown in FIG. 2, mouthpiece  2  can be inserted by elastic deformation. 
     A second embodiment of the mouthpiece, shown in FIG. 3, is substantially hollow. To prevent the collapse of hollow space  14  under the effect of underpressure produced by the above-mentioned vacuum source, which collapse would affect the communication of peripheral openings  8  with the vacuum source, there are provided a plurality of protrusions  16  integral with either he bottom and/or the roof of hollow space  14 , that will limit the amount by which the roof and the bottom of space  14  may approach one another. Protrusions  16  could also have the shape of crenellated ribbing that would also enhance the stiffness of mouthpiece  2 . 
     Further seen in FIG. 3 is a central opening  18  in active surface  6 , which is much larger than the peripheral openings  8  and which facilitates the passage therethrough of various implements, such as a morcellator or a suction needle. 
     FIG. 4 shows a pouch according to the invention, in the open state. Pouch  20  is made of a pliable, membranous material, is advantageously pre-shaped like the canopy of an umbrella, and is fixedly attached, e.g., by adhesive bonding, at selected points along substantially meridianal lines, to a plurality of finger-like elements  22 . Since the purpose of pouch  20  is first to engulf and then to enclose the resected specimen, e.g., a cyst, means must be at hand to first spread the pouch open to enable it to entrap the specimen, and then to close the pouch, retaining the specimen for imminent retrieval. 
     Therefore, the elements  22  are constituted by any suitable material or a combination of materials, e.g., plastic, metal or plastic-coated metal. The elements  22  are pre-shaped and adapted to assume a first state in which they flex outwardly and a second state in which they flex inwardly towards each other. 
     The finger-like elements advantageously may be made of a shaped-memory alloy, i.e., an alloy which “remembers” one or more shapes imparted to it at one or more predeterminable temperatures, and which reverts to those shapes whenever it is subjected to those temperatures. Such alloys are commercially available, for instance, Nitinol, a nickel-titanium alloy, or the like. Hence, in operation, when the elements  22  are exposed to a first temperature, e.g., room temperature, or a lower temperature obtained by cooling, they are caused to flex outwardly, i.e., to flare open. Since pouch  20  is attached to the elements  22 , the pouch is likewise caused to open, as shown in FIG.  4 . When the elements  22  are exposed to a second, higher temperature, e.g., body temperature, or heated, however, they are caused to flex inwardly towards each other. This change of shape of the elements is, of course, also imparted to pouch  20 , causing it to close as shown in FIG.  5 . The higher (transition) temperature could also be effected by passing a weak electric current through elements  22 , thereby achieving better control of the procedure. 
     Prior to use, finger-like elements  22  and pouch  20  are retained in a tubular member  24  as seen in the top view of FIG. 6, showing pouch  20  folded in its fully collapsed condition. 
     FIGS. 7-11 illustrate a laparoscopic system for acquisition and retrieval of resected biological specimens. As this system also incorporates the vacuum mouthpiece and pouch illustrated in FIGS. 1-5, reference will be made to some of these Figures in discussing the laparoscopic system according to the invention. 
     Referring now to FIG. 7, there is seen an outer tubular member  24 , the distal end  25  of which is designed to be introduced into a body cavity from which a previously resected specimen is to be retrieved. Introduction is effected in a per se known manner, using a trocar. The outside diameter of member  24  is of an order of 10 mm. 
     Further seen is an inner tubular member  4  of a length exceeding the length of member  24  and connectable at its proximal end to a vacuum pump (not shown). To the distal end of tubular member  4  is fixedly attached a vacuum mouthpiece  2  made of an elastically resilient material such as synthetic rubber or the like. In its free state as shown in FIG. 3, its outside diameter is much larger than the inside diameter of tubular member  24 . 
     Freely sliding inside outer tubular member  24 , there is arranged an intermediate tubular member  26  which also projects beyond the proximal end of member  24 . To the distal end of member  26  are fixedly attached, e.g., by welding or brazing, a plurality of finger-like elements  22  which cause pouch  20  to be first spread open and then, after it has engulfed the specimen to be retrieved, to close with the specimen inside, as explained above. 
     As further seen in FIG. 7, pouch  20  is provided at its center with an opening  28 , through which passes tubular member  4 . In its initial state, pouch  20  is fully collapsed, i.e., folded, its folds filling the annular space between tubular members  24  and  4 , as can be seen in FIG.  8 . 
     In actual operation, after the distal portion of the device, still in the state depicted in FIG. 7, is introduced into the body cavity using a per se known trocar, inner tubular member  4  is pushed out, thereby releasing vacuum mouthpiece  2  from its confinement in outer tubular member  24 . At the same time, the vacuum pump to which member  4  is connected is switched on. Due to the suction effect of the approaching mouthpiece  2 , the previously resected specimen will be drawn close and cling to it. More or less simultaneously, intermediate tubular member  26  is pushed out and elements  22 , previously restrained by tubular member  24  from assuming their flaring shape, now flare open, thereby opening pouch  20 . This situation is schematically illustrated in FIG. 9, showing specimen S clinging to vacuum mouthpiece  2  and finger-like elements  22  flexing outwardly, thereby opening pouch  20 , which now surrounds specimen S. The specimen can now be resected through the use of any suitable surgical instrument and the pouch  20  closed to engulf the resected specimen for safe retrieval (FIG.  10 ). In a case when shaped-memory elements are used, after the elements  22  have been largely exposed to the higher body temperature for a while (or have been electrically heated), they are affected by the high-temperature memory and flex inwardly, thereby closing pouch  20  and thus effectively capturing specimen S. 
     Further proceedings depend on the nature of the specimen. Fairly low-viscosity specimens, such as exudates, can be drawn off by a suction needle introduced into pouch  20  via opening  18  in mouthpiece  2 , or even by the latter itself. More solid specimens must be liquefied, which is best done with the aid of a morcellator  30 , as shown in FIG.  11 . This implement is introducible into closed pouch  20  via opening  18  in mouthpiece  2  and, driven at high speed by any suitable drive means, acts like a blender. Closed pouch  20  prevents spilling of the liquid into the abdominal cavity. The thus liquefied specimen can then be drawn off, either by the above-mentioned suction needle or directly by mouthpiece  2 . 
     It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrated embodiments and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.