Abstract:
A method and device for cutting and sealing of disposable multilumen tubing is disclosed. The method comprises providing a first surface and an opposite second surface, placing a portion of the multilumen tubing between the first and the second surface and applying heat and pressure to at least one of the first and the second surface so as to plastically deform and cut the said portion of the multilumen tubing and to heat-seal the cut ends thereof. The device for cutting and sealing comprises a first jaw and juxtaposed therewith a second jaw, said first and said second jaw are provided with respective first and second surface. The device further comprises biasing member exerting pressure on at least one of the said first and the second surface and a source of energy suitable for heating of at least one of the said first and the second surface.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates generally to the field of endoscopy and specifically to endoscopic apparatus used for colonoscopic procedures during which a flexible tube is inserted into the rectum and colon for examination of the colon interior for abnormalities. More particularly, the present invention refers to a method and device for cutting and heat-sealing of disposable multilumen tubing, which is used specifically, but not exclusively, with an endoscopic apparatus, having a disposable sleeve covering the flexible tube and which upon inflation enables advancement of the endoscope within the colon.  
       BACKGROUND OF THE INVENTION  
       [0002]     There are known endoscopes employing inflatable flexible sleeves for propulsion endoscope within colon.  
         [0003]     Voloshin (U.S. Pat. No. 6,485,409) discloses an endoscope, which comprises an endoscopic probe, a bending section for directing the probe within the colon (steering unit), an insertion tube and a flexible covering sleeve or a sheath, which is coupled proximally to the probe. The bending section of the endoscope is located behind the probe. The sleeve is attached to the endoscope in such a manner that its folded section is retained between a cap and an internal spindle, which are located between the insertion tube and the probe head. When inflated, the folded section unfolds over a flange of the internal spindle and an inner portion of the sleeve is pulled in a distal direction.  
         [0004]     In PCT/IL03/00661 an endoscope is described which employs a flexible inflatable sleeve, which before inflation is retained within a dispenser. The dispenser employed in this endoscope has entry and exit ports defining a transit passage through which the endoscope may pass. The dispenser is adapted to capture the sleeve as the endoscope is retracted through the transit passage in a proximal direction. In another embodiment, the dispenser includes an external sleeve fixed to the dispenser and this external sleeve is adapted to be extended from the dispenser when the endoscope is retracted so that the external sleeve covers the flexible sleeve. By virtue of this provision any contamination on the flexible sleeve remains within the external sleeve and does not contact the endoscope or any other objects or areas outside the patient&#39;s body. After the endoscope has been removed entirely from the flexible sleeve, the dispenser together with the external sleeve is discarded.  
         [0005]     It is mentioned in the above reference that the endoscope is provided with an internal sleeve, which is also known as a multilumen tubing, since it is usually fitted with appropriate passages or lumens as required for irrigation, suction and for passing endoscopic tools therethrough. During the endoscopic procedure the multilumen tubing is in flow communication with the body passage, which is under examination. The multilumen tubing fits over inside working channel (or so-called guiding channel) provided along the insertion tube.  
         [0006]     After the endoscopic procedure is completed, the endoscope is retracted from the body passage and there is a possibility for contaminating the endoscope&#39;s guiding channel by liquid or debris, which enter into the multilumen tubing during the endoscopic procedure and could leak out through the proximal extremity of the multilumen tubing as it is pulled outside through the guiding channel.  
         [0007]     It is mentioned in the above reference, that in order to prevent contamination either a tightly-fitting cup is placed over the proximal extremity of the multiluinen tubing in order to seal its interior off or the proximal extremity of the multilumen tubing is crimped or heat-sealed.  
         [0008]     Unfortunately absolutely no details are provided as to how this crimping or hot sealing procedure should be carried out, nor is construction of a device suitable for this purpose disclosed.  
       SUMMARY OF THE INVENTION  
       [0009]     The object of the present invention is to provide a new and improved method and device for preventing the spread of contamination originating from the disposable multilumen tubing used with an endoscope.  
         [0010]     For a better understanding of the present invention as well of its benefits and advantages, reference will now be made to the following description of its embodiments taken in combination with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  depicts a general view of an endoscopic apparatus of the invention, preferably a colonoscopic apparatus and its main components  
         [0012]      FIG. 2  is a general view of a disposable dispenser and multilumen tubing.  
         [0013]      FIG. 3  is a general view, showing the distal end of the multilumen tubing inserted within the dispenser and its proximal end is ready for insertion within a guide channel of an insertion tube.  
         [0014]      FIG. 4  is a general view, showing the proximal end of the multilumen tubing almost fully inserted within the insertion tube.  
         [0015]      FIG. 5  is a general view, showing the disposable multilumen tubing outside the dispenser.  
         [0016]      FIG. 6  is a general view, showing the proximal extremity of the multilumen tubing and a spacer fitting.  
         [0017]      FIG. 7  is a general view, showing the connector means attached to the proximal extremity of the multilumen tubing protruding from the spacer fitting.  
         [0018]      FIG. 8  is a general view, showing the operation handle of the endoscope connected to the control unit.  
         [0019]      FIG. 9  illustrates schematically the method and device for cutting and heat-sealing.  
         [0020]      FIG. 10  is a general view, showing the embodiment of the device for cutting and heat-sealing in operation.  
         [0021]      FIG. 11  is a general view, showing the embodiment of the device for cutting and heat-sealing.  
         [0022]      FIGS. 12-18  are general views, showing additional embodiments of the device for cutting and heat-sealing. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     With reference to  FIG. 1  an endoscopic apparatus, preferably a colonoscopic apparatus  10  is shown with its following main components. The apparatus comprises an endoscope having insertion tube  12  with its proximal section connected to an operation handle  14  and with its distal section  16  inserted in and protruding from a disposable dispenser  18 .  
         [0024]     It is seen also in  FIG. 1  that a protective sleeve covers distal section  16  of the endoscope. That part of the sleeve, which is seen in  FIG. 1 , comprises a frontal non-inflatable portion  20  and a rear, folded portion  22 . The frontal portion of the sleeve covers the distal section of the endoscope. The frontal portion does not inflate when the endoscope advances within the colon. The rear portion covers the insertion tube and unfolds when air or other fluid medium is supplied for inflating the sleeve. By virtue of this provision the feeding out sleeve propels the endoscope within the body passage. Explanation of this phenomenon can be found in the above referred to references. The endoscope of the present invention is of similar type in the sense that it employs the same propelling mechanism, which is based on inflation of a flexible protective sleeve coupled to the endoscope. It should be appreciated, however, that the present invention is not limited to the colonoscopic procedure and it can be employed in any other medical procedure requiring insertion of a probe in a body passage for inspection of its interior.  
         [0025]     It is seen also in  FIG. 1 , that the handle is connected by appropriate umbilical duct  24  to a control unit  26  provided with a source of compressed air for inflating and venting the sleeve. Proximate to the control unit a flask  28  is provided, which is filled with water, to be supplied under pressure into the body passage for irrigation. Water and air are supplied to the handle through dedicated tubes (not shown) attachable to the umbilical duct.  
         [0026]     One should bear also in mind that within the insertion tube are provided various devices, which are necessary for proper functioning of the endoscope. These devices are known per se. Among such devices one can mention vertebrae and strings, which can be manipulated by the handle, and a multilumen tubing with appropriate passages for supplying water, as required for irrigation or a vacuum required for suction. The multilumen tubing also is provided with a dedicated passage for introducing surgical instruments into the colon as might be required during the endoscopic procedure. Along the insertion tube might extend also a dedicated tube through which air is supplied as required for inflating the sleeve.  
         [0027]     The multulumen tubing extends through the endoscope and through the handle to a connector means  30 , which provides flow communication between lumens of the multilumen tubing and is attached to the umbilical duct tubes for supplying air and vacuum from the control unit and water from the flask.  
         [0028]     In  FIG. 2  is shown a general view of a disposable set for use with the endoscopic apparatus seen in  FIG. 1 . More detailed description of the set can be found in our patent application U.S. Ser. No. 60/570,608, whose disclosure is incorporated herein by reference. The set includes a disposable dispenser  18  and disposable multilumen tubing  32 , having its distal section inserted within the dispenser and its proximal section extending outside the dispenser. An end  34  of the proximal section is adapted for airtight connection to the connector means  30 .  
         [0029]     It is not seen in  FIG. 2  but should be appreciated that to the distal end of the multilumen tubing is attached a cap having a window fitted with transparent closure. Through this window illuminating light can propagate and thus viewing optics of a camera head may observe the interior of a body passage when the endoscope is inserted therein.  
         [0030]     It should be also born in mind that in  FIG. 2  the dispenser and the multilumen tubing are depicted during preparation for the endoscopic procedure. As shown in  FIG. 3  and  FIG. 4  during the preparation step the end  34  of the multilumen tubing is inserted within a guiding channel of the insertion tube  12 . Then distal section  16  of the endoscope is displaced along an arrow seen in  FIG. 4  and is inserted into the dispenser via an entry port  36 . After that the distal section of the endoscope is advanced along the dispenser until it protrudes therefrom. It is seen in  FIG. 4 , that the distal section of the endoscope terminates by an optical head  38 , which has saddle-like cross-sectional configuration enabling the multilumen tubing to pass therethrough and through the guiding channel (not shown)  
         [0031]     In  FIG. 5  the multilumen tubing is shown outside the dispenser but it should be born in mind that during the preparation procedure the multilumen tubing is retained within the dispenser, since it is a component of the disposable set.  
         [0032]     It is also seen that to the distal section of the multilumen tubing is attached a cap  40 . It is not shown specifically but should be appreciated that the cap has an access opening through which the interior of the body passage is accessible during the endoscopic procedure. The multilumen tubing is attached to the cap in such a manner that the access opening is in alignment with the passages of the multilumen tubing.  
         [0033]     The dispenser, the multilumen tubing and the tubes passing along the umbilical duct are manufactured from plastic material; they are cheap, disposable items, which are discarded at the end of the endoscopic procedure after extracting the endoscope from the body passage. By virtue of this provision preparation of the endoscopic apparatus to the new endoscopic procedure is simple, convenient and fast. Furthermore, by virtue of the disposable set spreading of any contamination from within the body passage is prevented.  
         [0034]     Referring now to  FIG. 6  it is shown a situation when the multilumen tubing has been fully inserted in the insertion tube and its proximal extremity protrudes from a lateral port  40  of the handle  14 . Attached to the lateral port is a spacer fitting  44 , which consists of two halves closable on the multilumen tubing and embracing its proximal extremity. The purpose of this spacer fitting is twofold. When the spacer fitting is in the assembled position shown in  FIG. 7 , it prevents displacement of the multilumen tubing inside the insertion tube during attachment the connector means. When the spacer fitting is in the disassembled position shown in  FIG. 10 , it exposes a portion of the multilumen tubing for cutting and heat-sealing as will be apparent later on.  
         [0035]     It should be appreciated that the multilumen tubing depicted in  FIG. 6  consists of two lumens, the first of them being provided with one passage (for suction or for entering a surgical instrument therethrough) and the second one being provided with two passages (for air and for water). The multilumen tubing protrudes through the spacer fitting and outside the fitting there is seen proximal end  46  of the first lumen and proximal end  48  of the second lumen. It should be appreciated, however, that instead of two separate lumens the multilumen tubing could consist of a single integral body provided with three passages extending therealong. The further explanation of the present invention will be referring to integral multilumen tubing.  
         [0036]     In  FIG. 7  is seen how a cylindrical connector means  50  is attached to the proximal extremity of the multilumen tubing. This connector means functionally is similar to the connector  26  shown in  FIG. 1 . The connector means is in airtight communication with the multilumen tubing and with the tubes extending along the umbilical duct for connecting to the control unit. Furthermore the connector means is provided with a dedicated lateral port through which a surgical tool can be inserted in the multilumen tubing and evacuated therefrom. In FIG. I is shown connector  26  provided with a lateral port  48 , while in  FIG. 7  is shown connector means  46  provided with a lateral port  50 .  
         [0037]      FIG. 1  and  FIG. 8  depict the endoscopic apparatus being ready for commencing the endoscopic procedure. During this procedure the multilumen tubing may be contaminated since during the endoscopic procedure its distal end is in communication with the interior of a body passage. At the end of the endoscopic procedure the umbilical duct is disconnected from the connector means and the multilumen tubing is evacuated from the insertion tube. This operation might be associated with spreading the contamination from the multilumen tubing through its open proximal end. Cutting and heat-sealing of the proximal extremity in accordance with the present invention reliably prevents the spreading of contamination from the proximal end.  
         [0038]     Referring to  FIG. 9   a  it is shown schematically the principle, on which is based the method and device for cutting and sealing in accordance with the invention. The device comprises a first heating jaw HJ 1  and a second heating jaw HJ 2 . The first heating jaw has a U-like end  56  and the second heating jaw has a bar-shaped end  58 . The U-like end is fitted with a first leg  60  having an opening, through which the bar-shaped end of the second jaw can pass and there is provided a possibility for relative linear displacement between the heating jaws. In practice the U-like end of the first heating jaw is displaceable with respect to the bar-shaped end of the second heating jaw. It is not shown in  FIG. 9 , but should be appreciated that appropriate mechanism is provided for linear displacement of the first heating jaw. A second leg  62  of the U-like end is fitted with a flat surface  64  facing towards an opposite flat surface  66  arranged on the bar-shaped end  58  of the second heating jaw. Protruding from the surface  64  towards the surface  66  a cutting edge  68  is provided. A corresponding depression  70  is formed on the opposite surface  66 .  
         [0039]     It is shown schematically in  FIG. 9   a  a biasing member BM, e.g. a coil spring. The biasing member urges the surface  64  of the first heating jaw to approach the surface  66  of the second heating jaw. In order to provide room between the surfaces one should overcome resistance of the biasing member and forcibly displace the first heating jaw so as to remove the surface  64  from the surface  66 . This situation is shown in  FIG. 9   a . It should be also appreciated that surfaces  64 ,  66  are made of electrically conductive material (e.g. copper) and the surface  66  is electrically connected to a source of electrical power (not shown). Therefore when electric current is passed through the surface  66 , it functions as an electrical resistance-heating element capable of transferring heat to any object which is brought in physical contact with it. In a situation when the surfaces approach each other the heat passes from the surface  66  to the surface  64  by conductivity.  
         [0040]     In  FIG. 9   b  is shown a situation when the first heating jaw is forcibly removed from the second heating jaw and a portion  72  of the multilumen tubing is placed between the surfaces  64  and  66 . A biasing member (not shown) exerts pressure on the surface  64  and thus on the multilumen tubing. At the same time the surface  66  is heated by electrical power supplied thereto and heats the multilumen tubing. Since the multilumen tubing is made of a thermoplastic material it yields and squeezes due to simultaneous influence of pressure and heat. In practice the surface  66  is heated up to 230-250° C. The cutting edge  68  cuts the multilumen tubing and gradually approaches depression  70 , while the flat surfaces  64 ,  66  deform the multilumen tubing as seen in  FIG. 9c . When the portion  70  is finally cut the opposite ends  74 ,  76  thereof become heat-sealed as seen in  FIG. 9   d.    
         [0041]     It can be readily appreciated that now, when the opposite ends  74 , 76  of the multilumen tubing are heat-sealed there is no possibility for the contamination accumulated during the endoscopic procedure to spread out from the proximal extremity of the multilumen tubing.  
         [0042]     Referring now to  FIG. 10  there is shown how cutting and heat-sealing is carried out in practice with the aim of the cutting and heat-sealing device corresponding to an embodiment shown in  FIG. 11 .  
         [0043]     It is seen that spacer fitting  44  is opened to expose the portion  72  of the proximal extremity of the multilumen tubing. The portion  72  is placed between the opposite surfaces  64 ,  66  of the heating jaws and is cut and heat-sealed due to simultaneous applying of pressure and heat.  
         [0044]     With reference to  FIG. 11  it is shown an embodiment of the device suitable for simultaneous applying of pressure and heat to the multilumen tubing. The device is configured as a pistol having a handle  78 , graspable by operator&#39;s hand and a working portion  80 . The working portion comprises a first heating jaw  82  terminating by the U-like end  52  and a second heating jaw, which is embraced by the first jaw and which terminates by the bar-shaped end  58 . The U-like end and the bar-shaped end are fitted with respective flat, opposite surfaces, which are seen in proximity to each other. It is not shown specifically but should be appreciated that the first heating jaw is linearly displaceable with respect to the second heating jaw and between the first jaw and the handle there is provided a biasing member forcing the first heating jaw to displace in a backward direction towards the second heating jaw. Pivotally connected to the handle  78  a trigger member  84  is provided, which upon pulling urges the first heating jaw against elastic force of the biasing member to be displaced in a forward direction so as to separate between the surfaces  64 ,  66 . It is also seen an electrical cord  86 , which electrically connects the device with a power supply source PSS for supplying electrical power required for the heating of the surface  66 .  
         [0045]     Referring now to  FIGS. 12-16  still another embodiment of the device for cutting and heat-sealing will be described. In  FIG. 12  is seen a general view of the device, which is, similarly to the previous embodiment, configured as a pistol, having a handle  78  carrying a working portion  80 . The working portion comprises a first heating jaw  82  provided with a forward U-like end  88 . Similarly to the previous embodiment the first heating jaw is linearly displaceable with respect to a second heating jaw and the second heating jaw terminates by a bar-shaped end  90 .  
         [0046]      FIG. 13  shows an enlarged view of the forward U-like end  88  of the first heating jaw. The second heating jaw is retained within the first jaw and is provided with a rear portion, which is connected to the handle. In this embodiment the device is not provided with a trigger member. In order to displace the first heating jaw in a forward direction and for separating the U-like end  88  from the bar-shaped end  90 , a pushing force should be applied by the operator&#39;s hand immediate to a rear portion of the first heating jaw.  
         [0047]      FIGS. 12 and 13  shows a situation where the U-like end of the first heating jaw approaches the bar-shaped end of the second heating jaw.  
         [0048]      FIGS. 14 and 15  depict a situation when the first heating jaw has been pushingly displaced forward with respect to the second heating jaw.  
         [0049]     As seen in  FIGS. 12, 13 ,  14 , and  15  the U-like end  88  of the first heating jaw is provided with a flat, metallic surface  92  fitted with a cutting edge  94 , while the bar-shaped end  90  of the second heating jaw is provided with an opposite flat, metallic surface  96  formed with a protrusion  98 . It is not shown but should be appreciated that the surface  96  is connected to a source of electrical current and can be heated when electrical current passes therethrough.  
         [0050]     As seen in  FIG. 16 a  biasing member (spring)  100  is deployed within the first heating jaw. The spring is connected to the first jaw and to the second jaw in such a manner that it always pulls the first jaw in a backward direction to bring the surface  92  in rapprochement with the surface  96  as shown in  FIGS. 12, 13 ,  16 . To separate between the surfaces one should apply pushing force to the rear portion of the first heating jaw for displacing it in a forward direction. The situation when the first jaw has been pushed forward and the surfaces  92 ,  96  have been separated is shown in  FIGS. 14, 15 .  
         [0051]     For linear displacement of the first heating jaw with respect to the second heating jaw appropriate guiding surfaces are made in the first and the second heating jaw.  
         [0052]     For heating the surface  96  a heating element  102  configured as metallic spiral is used. The heating element is deployed within an intermediate elongated bushing  104 . The bushing is made of material having high thermal conductivity. The bushing terminates by an extremity  106 , on which tightly seats a tail portion  108  of the surface  96 . Disposed within the first heating jaw an adapter  110  holds the bushing  104  in place. The ends of the spiral heating element are electrically connected to the power supply source PSS by wires  112 , 114  passing through the adapter and the handle.  
         [0053]     It is advantageous if before commencing the cutting and sealing a thermal insulation layer, e.g. thing layer of Teflon is put on the portion of the multilumen tubing. The insulation layer prolongs the time during which the portion of the multilumen tubing is exposed to the simultaneous influence of heat and pressure, without however of premature collapsing. By virtue of this provision the cut ends of the multilumen tubing are reliably sterilized, while remaining intact and thus possibility for cross-contamination is avoided.  
         [0054]     It should be appreciated that the above disclosed method and device for cutting and heat-sealing can be employed not only in connection with an endoscope, which is propelled by an inflatable sleeve. It can be used with any other endoscopes, in which it is required to prevent spreading of contamination from the multilumen tubing when it is evacuated from the endoscope.  
         [0055]     It should be also appreciated that the invention is not limited to the above-described embodiments and that changes and one ordinarily skilled in the art can make modifications without deviation from the scope of the invention, as will be defined in the appended claims.  
         [0056]     For example the device for cutting and heat-sealing could be configured not as a pistol, but as pliers. An example of such device is seen in  FIGS. 17, 18 . It is seen that in this embodiment two heating jaws  112 ,  114  are provided. The heating jaws are pivotally displaceable with respect to each other. The heating jaws are fitted with corresponding metallic surfaces  116 , 118 . The heating jaws are always pressed to each other by a spring (not shown) provided in the pliers. An electrical cord  120  is provided for supplying electrical power required for heating of at least one of the surfaces  116 , 118 . To separate the metallic surfaces one should pull handles  122 , 124  apart so as to pivotally displace the jaws as seen in  FIG. 18 . Then a portion of the multilumen tubing is placed in a free space  126  provided between the surfaces  116 , 118  and the handles are released. The biasing member brings the jaws in proximity to each other and the portion of the multilumen tubing placed in the space  126  is subjected to simultaneous influence of pressure and heat.  
         [0057]     It should be born in mind also an embodiment, in which the biasing member always brings the jaws together when the handles are brought apart and in which for separating the surfaces  116 , 118  one should push on the handles  122 , 124  so as to bring them together instead of pulling them apart.  
         [0058]     It should also be appreciated that the features disclosed in the foregoing description, and/or in the following claims, and/or in the accompanying drawings may, both separately and in any combination thereof, be material for realizing the present invention in diverse forms thereof.  
         [0059]     When used in the following claims, the meaning of terms “comprise”, “include”, “have” and their conjugates is “including but not limited to”.