The present invention relates to a multi-lumen sleeve having lumens with tapered ends for use in endoscopic surgical procedures.
Endoscopic procedures are used through much of contemporary surgery for a variety of diagnostic and therapeutic procedures. Gastrointestinal (GI) tract polyps, for example, are resected using endoscopic techniques and then biopsied. Lesions are cauterized using endoscopes.
Since there are many different uses for endoscopes, their design is varied, depending on their intended purpose. Among others, there are upper endoscopes for examination of the esophagus, stomach and duodenum, urethroscopes for examining the urethra and bladder, colonoscopes for examining the colon, laparoscopes for examining the peritoneal cavity, and sigmoidoscopes for examining the rectum and sigmoid colon.
Often, endoscopic procedures require the use of multiple working instruments. Because these multiple instruments must work in cooperation, their maneuverability and cooperation at the endoscope tip is critical to the success of the surgical procedure.
In a procedure and system discussed in “Endoscopic Full Thickness Resections Using Surgical Compression Clips”, U.S. patent application Ser. No. 11/647,912, filed Dec. 29, 2006, by the present inventors, there is described the use of a plurality of working instruments with an endoscope and this document is incorporated by reference herein. The combination of working instruments and endoscope is employed in concert using a multi-lumen sleeve.
While such multi-lumen sleeves are known, they suffer from a drawback. Working instruments are inserted into the secondary lumens and the endoscope shaft into the primary lumen of the multi-lumen sleeves. Often the working instruments are advanced into place only after the endoscope has reached its desired position. However, in those instances when advancing the endoscope and the working instruments together to the site of a lesion, the endoscope shaft and the working instruments do not necessarily proceed in tandem, the working instruments remaining somewhat behind the insertion shaft. Additionally, when the shaft is articulated the working instruments do not move in a coupled fashion with the endoscope shaft. This increases the difficulty in employing such systems in surgical procedures.
Therefore, there remains a need for a method, a system and/or elements of a system which would facilitate coupled movement and articulation between the endoscope shaft and its associated working instruments during surgical procedures.
“Proximal” relates to the side of the endoscope or devices closest to the user, while “distal” refers to the side of the endoscope or devices furthest from the user. Similarly, “proximal” refers to the side of the multi-lumen sleeve encasing the endoscope or of the working instruments associated with the endoscope or endoscopic system closest to the user and “distal” refers to the side furthest from the user.
“Sleeve” and “sheath” will herein be used interchangeably without intending to distinguish between them, except where specifically indicated.
“Polyp” as used in the specification and claims below is not intended to restrict the system, subsystems, elements and method discussed herein to polyps alone. Other types of suspect lesions may also be treated using the system, subsystems, elements and method discussed herein.
“Lesion” may be used in place of the word “polyp” “perforation”, hemorrhoids, tissue adjacent to a resected site, or openings within tissue generated by any surgical procedure or occurring naturally, without any intent at differentiating between these different types of lesions, except where specifically indicated.
“Gastrointestinal tract” or its equivalents may be used in the specification and claims without the intent of being limiting. Other organ systems, and lesions found therein, are also contemplated as being treatable with the system, subsystems, elements and methods discussed in the present specification.
“Working conduit”, when used in the specification and claims, may refer to a working channel of the endoscope or a secondary lumen of the sleeve whose primary lumen encases an endoscope's insertion shaft.
It is an object of the present invention to provide a multi-lumen sleeve that allows for coupled usage of one or more working instruments with an endoscope shaft.
It is a further object of the present invention to provide a system employing a multi-lumen sleeve that allows for coupled motion and articulation between one or more working surgical instruments of the system and an endoscope shaft.
It is an object of the present invention to provide a coupling interface element for working instruments that allow for coupling motion between an endoscope and auxiliary working surgical instruments.
The endoscopic system, its sub-systems and elements, and the method described herein may find use in surgical procedures involving lesions arising in, for example, but without intending to be limiting, the bowel, rectum, appendix, gallbladder, uterus, stomach, esophagus, lungs, bladder, vagina, etc.
In one aspect of the present invention there is provided a multi-lumen sleeve for use with an endoscope shaft and one or more working surgical instruments. Each shaft and surgical instrument has an end portion. The sleeve includes a primary lumen to which is joined one or more secondary lumens. Each lumen has a free end for connection to the end portion of a selected one of the shaft and the one or more working surgical instruments. Each of the free ends of the primary and secondary lumens is adapted to fit about and support the end portion of the selected one of the shaft and the one or more working surgical instruments. This facilitates concerted translational and rotational motion and coupled articulation between the shaft and the one or more working surgical instrument.
In an embodiment of the first aspect of the present invention, one or more of the free ends of the lumens is adapted to fit about and support a coupling interface element positioned therein. The element is disengageably joined to the end portion of one of the one or more working surgical instruments.
In a second aspect of the present invention, there is provided a system for performing endoscopic surgical procedures. The system comprises an endoscope having an insertion shaft with an end portion, one or more working surgical instruments each having an end portion, and a multi-lumen sleeve. The sleeve comprises a primary lumen to which one or more secondary lumens are joined. Each of the lumens has a free end for connection to the end portion of a selected one of the shaft and the one or more working surgical instruments. Each of the free ends of the primary and secondary lumens is adapted to fit about and support the end portion of the selected one of the shaft and the one or more working surgical instruments. This facilitates concerted translational and rotational motion and coupled articulation between the shaft and the one or more working surgical instrument.
In an embodiment of the second aspect of the present invention the one or more of the free ends of the lumens is adapted to fit about and support a coupling interface element positioned therein, The element is disengageably joined to the end portion of one of the one or more working surgical instruments. In instances of this embodiment, one of the one or more working surgical instruments is extendable from the free end of one of the one or more secondary lumens after disengaging from the coupling interface element, the interface element remaining supported at the free end of the secondary lumen.
In yet a third aspect of the present invention, there is provided a system for performing endoscopic surgical procedures. The system comprises an endoscope having an insertion shaft with an end portion, a multilumen sleeve and a plurality of working surgical instruments, each of the instruments having an end portion. The multi-lumen sleeve comprises a primary lumen having a free end and one or more secondary lumens, joined to the primary lumen, and each having a free end. The plurality of working surgical instruments comprise: a compression clip for compressing tissue, the clip having an open position and a closed position, and configured to receive tissue therethrough when in its open position, and operative to apply a compression force to the tissue when closed thereabout; a clip applier in mechanical communication with the clip for advancing the clip through one of the one or more secondary lumens; and a grasper assembly selectably extendable through a selected one of the one or more secondary lumens and a working channel of the endoscope for grasping and pulling tissue through the clip when the clip is in its open position. Each of the free ends of the primary and secondary lumens is adapted to fit about and support the end portion of a selected one of the shaft and one of the plurality of working surgical instruments, thereby to facilitate concerted translational and rotational motion and coupled articulation between the shaft and one of the working surgical instruments.
In an embodiment of the third aspect of the present invention, one or more of the free ends of the lumens is adapted to fit about and support a coupling interface element positioned therein. The element is disengageably joined to the end portion of one of the one or more working surgical instruments. In instances of this last embodiment, one of the one or more working surgical instruments is extendable from the free end of one of the one or more secondary lumens after disengaging from the coupling interface element, the interface element remaining supported at the free end of the secondary lumen.
In another embodiment of the third aspect of the present invention, the system further includes a severing element for resecting tissue. The severing element is selectably extendable through a selected one of the one or more secondary lumens and a working channel of the endoscope so as to be brought into a position of operational proximity to tissue extending through the compression clip.
In yet another aspect of the present invention, there is provided a system for performing endoscopic surgical procedures for use with a multi-lumen sleeve, the sleeve having a primary lumen having a free end, and one or more secondary lumens, joined to the primary lumen, each secondary lumen having a free end. The system comprises an endoscope having an insertion shaft insertable into the primary lumen, the shaft having an end portion, and a plurality of working surgical instruments each having an end portion. The plurality of instruments comprises a clip having an open position and a closed position and configured to receive tissue therethrough when in its open position, and operative to apply a compression force to the tissue when the clip is closed thereabout; a clip applier for advancing the clip through a secondary lumen of the sleeve and for positioning the clip near the tissue to be compressed; and a grasper assembly selectably extendable through a selected one of the one or more secondary lumens and a working channel of the endoscope for engaging and pulling the tissue through the clip when the clip is in its open position. Each of the free ends of the primary and secondary lumens is adapted to fit about and support the end portion of the selected one of the shaft, the clip applier and the grasper assembly, thereby to facilitate concerted translational and rotational motion and coupled articulation between the shaft, the clip applier, and the grasper assembly.
The present invention will be more fully understood and its features and advantages will become apparent to those skilled in the art by reference to the ensuing description, taken in conjunction with the accompanying drawings, in which:
Similar elements in the Figures are numbered with similar reference numerals.
The sleeve, also sometimes denoted herein as the sheath, of the present invention is a multi-lumen sleeve with an endoscopic insertion shaft positioned in the sleeve's primary lumen and one or more working instruments, such as, but not limited to a clip and its applier, a severing instrument and a grasper assembly, positioned in one or more secondary lumens of the sleeve. At the distal end of the sleeve the lumens of the sleeve are tapered or otherwise adapted to connect to, fit about and support the distal ends of the endoscope shaft or working instruments. When the distal ends of the lumens are tapered they wedge the working instruments into the lumens of the sleeve. They advance in concert with the endoscope shaft and importantly, also articulate in tandem with the endoscope shaft. In cases where the tapering is insufficient or inefficient, there may be a coupling interface element around a working instrument which allows the working instrument to be wedged in the secondary lumen as required for coupled motion and articulation.
Multi-lumen sleeves are shown in
The distal end 152 of the insertion shaft of the endoscope includes a working channel 154, and at least one auxiliary element 157, such as optics, illumination, irrigation etc. In
When inserting the sleeve-encased endoscope into a patient, the secondary lumens 158 typically but without being limiting, are collapsed. Keeping the secondary lumens collapsed allows for a smaller profile as the endoscope is inserted into a body cavity, wending its way toward a lesion. One method of keeping the secondary lumens collapsed and substantially adjacent to the primary lumen 155 is by using bands 160, typically, but without intending to be limiting, bands made of silicone.
The multi-lumen sleeve 150 can be made of any of many different types of flexible plastics. Without intending to limit the choice of flexible plastics or elastomers, these may include polyethylene, polyurethane, polyvinyl chloride and almost any other medical grade plastic.
Secondary lumens 158 may be formed using any of several known methods for working sheet plastics; most typically the secondary lumens 158 are formed integrally with the primary lumen. The secondary lumens can be kept collapsed by directly extruding the multi-lumen sleeve with the secondary lumens in their collapsed positions. Secondary lumen(s) may also be attached to a primary lumen using one of many techniques known to those skilled in the art such as by using a suitable medical grade glue or solvent, by employing soldering, by heat treatment, or by using high frequency welding.
High frequency (HF) plastic welding may be used to weld multiple single secondary lumens to the primary lumen producing sleeve shapes shown in
While in the embodiments described above the primary lumen is continuous, in other embodiments it need not be. In these other embodiments, the primary lumen may include holes, be net-like, etc.
Reference is now made to
The present invention as presented in
Reference is now made to
In some embodiments, not all of bolded lines 159 are heat welded. If some lumens do not require tapered, constricted ends, lines 159 are not heat welded. In other embodiments, only one line 159 per lumen may be heat welded. This controls the position of the coupling element discussed herein below and thus the position of the working instruments relative to the endoscope and its working channel. In yet other embodiments, the excess plastic in triangular areas 163 or 165 or both may also be cut off.
The tapered constricted distal end of a secondary lumen can be formed so as to fit the size, that is the outer diameter, of the working instrument expected to be inserted into that lumen. Similarly, the reduced diameter of a primary lumen can be formed so as to fit the size, the outer diameter, of the endoscope to be inserted into that lumen. Similarly, the reduced diameter of a secondary lumen can be formed so as to fit the size of a coupling element (as discussed below) disengagably joined to a working instrument. Similarly, the reduced diameter of a secondary lumen can be formed so as to fit the size of a covering or casing associated with a working instrument.
While heat welding as shown by diagonal bold lines 159 in
In general, in endoscopic surgical procedures, the primary lumen of the sleeve should be fitted over the endoscope's insertion shaft in such a way that there is no relative axial movement between the lumen and endoscope shaft. As noted above, this can be achieved by using various techniques, including but not limited to, the use of bands. However, it may also be achieved by reducing the primary lumen's 155 diameter at its distal end by the method discussed in conjunction with
Turning to
Clip 10 is then opened by applier 30 in order to pull lesion L through the clip.
Until clip 10 is opened and positioned close to lesion L, the grasper remains within a connector tube (not shown) inside lumen 158. After clip 10 is opened, vacuum cup 1022 advances out of lumen 158 and opens in stages. Using an articulation wire to maneuver flexible cup transporter 1020, here formed having a spring construction, vacuum cup 1022 is positioned to grasp lesion L through open clip 10 (
Lesion L is then pulled by vacuum cup 1022 through open clip 10, and subsequently, clip applier 30 closes clip 10 around pulled lesion L. This is shown in an isometric view in
Lesion L compressed by clip 10 may be severed by a severing device 310 (not shown) introduced through a working channel of endoscope E or through another secondary lumen of the sleeve. The actual step of severing is not shown.
After severance of lesion L, the severed polyp held by the vacuum cup 1022 of the grasper, together with the remainder of the grasper assembly, the severing device 310 and the endoscope shaft, are retracted in the direction of the proximal end of the endoscope and withdrawn from the body. Withdrawal directly from the body organ is a straight-forward step, and therefore this step is not presented in a separate Figure. Lesion L can then be biopsied or treated as needed by a physician.
The closed surgical compression clip 10 remains around that portion of the GI wall from which the lesion L was resected. Compression continues until necrosis is induced and healing of the resected site occurs. Clip 10 is naturally expelled from the body through the rectum.
Reference is now made to
The vacuum cup cover 1018 of grasper assembly 1000 is brought to the tapered end of secondary lumen 158 (
With endoscope E, vacuum cup cover 1018 of grasper assembly 1000 and coupling interface element 85 attached to clip applier 30 all wedged in their respective lumens, it is readily evident that coupled motion and articulation of the two working instruments and endoscope E as shown in
When the clip applier is withdrawn it may be pulled back and reengaged with coupling interface element 85 and the applier 30, and element 85 together may be withdrawn from the lumen by pulling both in the lumens proximal direction.
In
It should be evident to one skilled in the art that the present invention can be used in surgical procedures of many different organs in many different organ systems, with little or no modification. Such organs include, but are not limited to, the bowel and rectum and other organs of the gastrointestinal (GI) tract, the urinary bladder and other organs of the urinary tract, the uterus, the liver, the esophagus, the gall bladder, and the lungs.
“Endoscope”, as used herein, contemplates the use of the present invention with all different types of invasive instruments, flexible or rigid, having scope features. These include, but are not limited to, instruments referred to as endoscopes, colonoscopes, gastroscopes, laparoscopes, and rectoscopes. Such instruments, as is readily known to those skilled in the art, are subsumed within the term endoscope. The present invention, while discussed in terms of endoscopes can readily be adapted for use with each of these instruments with little or no modification. It should also be noted that the use of the term “endoscopic” is to be construed as referring to the many different types of invasive scopes subsumed under the term endoscopes. As known by those skilled in the art the term “invasive” denotes a medical procedure requiring insertion of an instrument or device into the body through the skin or a body orifice for diagnosis or treatment.
It should be readily apparent to one skilled in the art that the device and method of the present invention can be used in surgical procedures on animals, particularly mammals, as well as on humans.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
It will be appreciated by persons skilled in the art that the present invention is not limited by the drawings and description hereinabove presented. Rather, the invention is defined solely by the claims that follow.
The present application claims priority rights from U.S. Provisional Application 60/897,247, filed Jan. 25, 2007.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IL08/00012 | 1/2/2008 | WO | 00 | 1/6/2011 |
Number | Date | Country | |
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60897247 | Jan 2007 | US |