Abstract:
A balloon endoscope device having a shaft with a distal end that allows for blunt dissection is provided. The shaft utilizes a plurality of separately inflatable balloons that alone or together with exterior functional channels (e.g., instrument channels, air channels, water channels, suction channels) circumferentially surround the distal end of the shaft to better position and maneuver the distal end as it advances through tissue planes and once it reaches a target working space or operative site.

Description:
RELATED APPLICATION  
       [0001]     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/800,374, filed May 15, 2006, which is fully incorporated herein by reference. 
     
    
     TECHNICAL FIELD  
       [0002]     The present invention generally relates to an endoscope device having a shaft with a distal end that allows for blunt dissection, and more particularly relates to an endoscope device that utilizes a plurality of inflatable balloons circumferentially surrounding the distal end of the device&#39;s shaft to better position and maneuver the distal end as it advances through tissue planes and once it reaches a target working space or operative site.  
       BACKGROUND AND SUMMARY OF THE INVENTION  
       [0003]     Endoscopes have been used for many years for viewing within a desired region of a patient&#39;s body through the patient&#39;s airway, other natural orifices, or a surgical incision. An endoscope typically has an elongated flexible shaft with a control head at its proximal end. The flexible shaft is equipped with one or more functional channels (e.g., instrument channels, air channels, irrigation channels, suction channels) that extend along the length of the flexible shaft from the distal end to the control head. The control head is connected to a light source, air/water supply and suction via an “umbilical” cord.  
         [0004]     For fiber-optic endoscopes, the flexible shaft is also equipped with a channel holding optical fibers (i.e., an image guide) for carrying an image from the distal end of the shaft to the control head, where it can be viewed through an eyepiece by a physician.  
         [0005]     For video-endoscopes, a Charge Coupled Device (CCD), which serves as an image-capturing means, is located at the distal end of the endoscope. Captured images are compressed and recorded on, for example, a hard disk, a removable memory device, an optical disk, or a magneto-optical (MO) disk.  
         [0006]     The tip of the endoscope is controlled using pull wires attached at the tip just beneath the surface of the flexible shaft, and passing back through the length of the shaft to angling controls in the control head of the endoscope. Two angling wheels or knobs located on the control head for up/down and right/left movement incorporate a friction braking system, so that the tip can be fixed temporarily in any desired position.  
         [0007]     Surgeons in the past have used blunt-tipped instruments as well as balloons in connection with endoscopic surgery to dissect tissue in order to develop a working space in the interior of the body. Balloon type surgical instruments have been developed to assist in this regard. Several of these prior art instruments are described below.  
         [0008]     U.S. Pat. No. 5,762,604 describes a surgical instrument that utilizes an inflatable, transparent balloon. The instrument serves to dissect and form a dissected viewing space within the interior of the body to provide adequate depth of field for endoscopic viewing. The instrument includes a transparent tipped dissector-guide 5 having a guide member 10 with an interior lumen (cavity) 14 (dimensioned to accommodate a viewing scope or endoscope 22) as well as a working channel 34 (for an elongate trocar). The guide member 10 affords the surgeon contemporaneous vision through the far end of the guide 10 as the instrument navigates the interior of the body. Metal band 132 and balloon constraining sleeve 133 are employed to constrain balloon 120 in a first collapsed position around guide member 10. The constraining sleeve 133 is provided with a weakened, perforated surface that will give way and burst when an inflation medium is introduced into balloon chamber 122 allowing the balloon to deploy to the inflated position. As the balloon inflates, tissue is dissected by the balloon generally applying forces perpendicular to the tissue being dissected or separated. When balloon 120 is inflated, it is disposed in a “hot dog bun” shape around the guide 10, offering increased depth of field in all directions around lens 32 of endoscope 22. Procedures are described in this patent as being performed on an outer surface of the inflated balloon. See e.g., Cols. 7 to 8, lines 60 to 3, of the &#39;604 patent.  
         [0009]     U.S. Pat. Nos. 5,607,441 and 5,707,382 both describe a surgical instrument that includes an assembly 10 consisting of two primary components, namely, a balloon dissector 11 for the dissection of internal bodily tissue to form an operative space during a surgical procedure, and an endoscope 12 for providing simultaneous visualization during the surgical procedure as the dissector is advanced through tissue and the operative space is formed. The balloon dissector 11 basically comprises a conventional trocar cannula 13, an extension assembly 14 (with transparent tissue-contacting element 24), and an inflatable balloon 15. Tubular sleeve 17 connects trocar cannula 13 and extension assembly 14 and is sized to receive an endoscope. An endoscope would be inserted distally in assembly 10 through tubular sleeve 17 until it abuts ring 23 at the distal end of the extension assembly 14. Use of assembly 10 is described in Cols. 5 to 6, lines 55 to 19, of the &#39;382 patent, and is shown in FIGS. 3 to 5, of this patent. To summarize, once the assembly 10 is positioned parallel to adjacent tissue layers with the aid of the endoscope, the balloon 15 is inflated to form an operative space. The balloon 15 is then deflated, and the assembly including the balloon dissector 11 removed and another trocar cannula 35 introduced into the operative space.  
         [0010]     U.S. Pat. Nos. 5,938,585 and 6,277,065 both describe an anchoring and positioning balloon device shaped like a cradle that is deployed using a side-view type endoscope 10. Endoscope 10 includes an illumination device 20, a viewing device 22, and a working lumen or channel 24, all contained within window section 18. A cradle shaped inflatable balloon 30 is attached to the distal end section 12 of the endoscope 10. During operation of the endoscope 10 with the balloon 30 inflated, the cradle portion 34 spaces the window section 18 from the examining area, thus providing a good view of and a sufficient working space relative to the body cavity wall 27 (see Cols. 3 to 4, lines 59 to 7, of the &#39;065 patent).  
         [0011]     US 2005/0159645 A1 describes a sheath for use with a medical device such as an endoscope, that comprises: an elongated body having a proximal end and a distal end; a main lumen extending through the elongated body from the proximal end to the distal end; and one or more inflatable balloons mounted on an outside surface of the elongated body proximate to the distal end. Embodiments employing multiple balloons mount the balloons 16, 18, 52, 54, 56 in isolated fashion on the distal end of the elongated body (see FIGS. 1A, 1B, 1C), or along the length of the elongated body (see FIGS. 4A and 4B).  
         [0012]     Unfortunately, the use of single balloons or multiple isolated balloons on the distal end of these prior art devices renders the positioning and advancement of the devices between/through natural tissue planes difficult to control.  
         [0013]     It is therefore an object of the present invention to provide an endoscope device capable of blunt dissection that allows for improved control over the positioning of the distal end of the device&#39;s shaft between natural tissue planes (e.g., subcutaneous, subfascial, intraperitoneal, intrathoracic, intracranial tissue planes) and further allows for improved control over the shaft&#39;s advancement through these tissue planes.  
         [0014]     The present invention therefore provides an endoscope device that comprises a shaft having a distal end and a plurality of separately inflatable balloons that alone or together with exterior functional channels (e.g., instrument channels, air channels, water channels, suction channels) circumferentially surround the distal end of the shaft.  
         [0015]     In a preferred embodiment, the inventive endoscope device comprises: a shaft made up of a flexible or partially flexible tubular member having a distal end, and interior optical and inflation channels extending there through; functional channels adapted to extend along an outer surface of the tubular member; and a plurality of separately inflatable balloons, where the balloons together with the exterior functional channels circumferentially surround the distal end of the tubular member.  
         [0016]     The present invention further provides a method of dissecting layers of tissue to form a working space between the tissue layers and then performing an endoscopic procedure within the newly formed working space, which method comprises: 
        providing an endoscope device as described hereinabove, wherein the balloons located on the distal end of the device&#39;s shaft are fully deflated;     inserting the distal end of the shaft between the layers of tissue;     advancing the distal end of the shaft between the tissue layers by sequentially inflating and deflating various balloons until a desired length of dissection has been completed;     inflating all or some of the balloons to form a working space between the tissue layers; and     repositioning the distal end of the shaft within the newly formed working space, as necessary, while performing an endoscopic procedure therein by inflating and deflating various balloons.        
 
         [0022]     Other features and advantages of the invention will be apparent to one of ordinary skill from the following detailed description and accompanying drawings. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]     Particular features of the disclosed invention are illustrated by reference to the accompanying drawings, in which:  
         [0024]      FIG. 1  is a perspective side view of a preferred embodiment of the shaft of the endoscope device of the present invention; and  
         [0025]      FIG. 2  is an enlarged perspective view of the distal end of the shaft shown in  FIG. 1 .  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0026]     Although the shaft as described herein forms part of an endoscope device, it is not so limited. The inventive shaft may be used as a shaft for a catheter or other similar device, or it may constitute a jacket or sheath for such a medical or surgical device for adding protection and functionality thereto.  
         [0027]     Moreover, although the ability of the inventive endoscope device to more effectively and efficiently perform blunt dissection of tissue planes will be emphasized herein, the device&#39;s balloons may be used for a number of other purposes, including, but not limited to, distending a body cavity (e.g., peritoneal cavity) in which an operation is to take place, thereby obviating the need for insufflation, facilitating intubation of, for example, the ampula of vater by acting as a scaffold against the duodenum wall, and blocking blood vessels to control bleeding/hemorrhaging. Moreover, and as will be readily appreciated by one skilled in the art, the device&#39;s balloons serve as a cushion to protect the mucosa during endoscopic procedures requiring the device&#39;s shaft to follow a tortuous path (e.g., endoscopic colon and rectal procedures), thereby decreasing iatrogenic injuries.  
         [0028]     Referring now to the drawings in detail, a preferred embodiment of the shaft of the balloon endoscope device of the present invention is shown generally at  10 . Shaft  10  is part of an end-view type endoscope device that allows for blunt dissection of tissue planes, while providing an operator with an image (e.g., a charge-coupled image). As best shown in  FIG. 1 , shaft  10  basically comprises: (a) a flexible or partially flexible tubular member  12  having a distal end  14 , and an interior optical channel  16  and four interior inflation channels (not shown) extending there through; (b) four functional channels  18   a ,  18   b ,  18   c ,  18   d , adapted to extend along an outer surface  20  of the tubular member  12 ; and (c) four separately inflatable balloons  22   a ,  22   b ,  22   c ,  22   d . In this embodiment, each interior inflation channel is in fluid communication with a different balloon or balloon chamber, and all such inflation channels are in further fluid communication with a control means, such as a handheld control dial, for separately inflating and deflating each balloon  22   a ,  22   b ,  22   c ,  22   d.    
         [0029]     As best shown in  FIG. 2 , functional channels  18   a ,  18   b ,  18   c ,  18   d , terminate in exit ports  24   a ,  24   b ,  24   c ,  24   d , and together with balloons  22   a ,  22   b ,  22   c ,  22   d , circumferentially surround the distal end  14  of the tubular member  12 . Opposing channels  18   b  and  18   d  are used to supply either irrigation fluid or suction, while opposing channels  18   a  and  18   c  are instrument channels, which may be used to deliver any surgical instrument adapted to contact, grasp or sever tissue including, but not limited to, forceps, scissors, knives, staplers, clip appliers, and other like devices. Although these channels are shown as circular in cross-section, their cross-section could be trapezoidal or any other suitable shape.  
         [0030]     When balloons  22   a ,  22   b ,  22   c ,  22   d , are fully deflated, their thickness approximates the outside diameter of the functional channels  18   a ,  18   b ,  18   c ,  18   d , thereby forming a substantially uniform layer in terms of thickness about the distal end  14  of the tubular member  12 . It is noted that the use of a plurality of smaller-sized balloons on the distal end  14  of the shaft  10  eliminates the need to physically constrain these balloons during introduction of the shaft  10  into a body cavity. When balloons  22   a ,  22   b ,  22   c ,  22   d , are all at least partially inflated, the balloons touch adjacent balloons and form a substantially continuous outer surface about the distal end  14  of the tubular member  12 .  
         [0031]     As will be readily evident to one skilled in the art, in addition to allowing for improved control over its positioning and advancement through tissue planes, which will be described in more detail below, the inventive balloon endoscope device provides an operator with images (e.g., charge-coupled or video images) of the area being dissected as well as the ability to, among other things, apply clips, irrigate, apply suction and cut vessels as the shaft  10  is being advanced. Once a desired length of dissection has been completed, all or some of the balloons may be inflated to form a working space between the tissue layers, at which time necessary surgical instruments may be introduced through functional channels  18   a ,  18   c , to perform the desired procedure(s).  
         [0032]     The balloon endoscope shaft  10  of the present invention can be sized to render it suitable for performing a number of different medical or surgical procedures. By way of example, the inventive shaft  10  may be used for (1) plastic surgical procedures (e.g., cosmetic procedures such as brow lifts and facelifts), allowing subcutaneous tissue and fascial planes to be pulled up or elevated with only a very small incision, resulting in a beneficial decrease in the amount of scarring, (2) intracranial procedures such as evaluating and/or evacuating a hematoma using small bur holes in the skull, (3) harvesting veins without the need for long incisions that are susceptible to wound break down and infection, (4) general surgical procedures (e.g., endoscopic and laparoscopic gastrointestinal procedures including endoscopic colonoscopies), (5) thoracic surgical procedures, eliminating the need for single lung ventilation anesthesia (i.e., deflating and stopping ventilation to the lung involved in a procedure) and thereby allowing a patient, who typically has low pulmonary reserve and would not tolerate single lung ventilation, to continue to breathe from both lungs, and (6) bariatric surgical procedures. Preferred outside diameters for the inventive shaft  10  when used for the above-described medical or surgical procedures are set forth in Table 1 below.  
                       TABLE 1                       Medical or Surgical Procedure   O.D. min   1  (mm)   O.D. max   2  (mm)                   Plastic surgical procedures   3-5   15-20       Intracranial procedures   3-5   10-15       Vein harvesting   5-8   25-30       General surgical procedures   5-20   25-&gt;150       Thoracic surgical procedures   5-20   25-150       Bariatric surgical procedures   5-8   25-30                   1 O.D. min  - The outside diameter in millimeters (mm) when the balloons are fully deflated.              2 O.D. max  - The outside diameter in mm when the balloons are fully inflated.             
 
         [0033]     In addition to the benefits noted above, the inventive balloon endoscope device obviates the need for insufflation and thus the need for administering anesthesia or paralyzing agents to a patient, thereby allowing certain laparoscopic procedures, while still performed in an operating room, to be carried out more cost effectively and with reduced risk to the patient. The inventive endoscope device allows other laparoscopic procedures such as laparoscopic exploration and tissue biopsy of the peritoneal and retroperitoneal spaces to be performed bedside for critically ill and unstable patients.  
         [0034]     The balloons used in the present invention may adopt any size and shape, but preferably are sized and shaped so as to collectively form a substantially continuous surface about the distal end  14  of the tubular member  12  when all are similarly inflated. In a preferred embodiment, and as best shown in  FIG. 2 , each balloon  22   a ,  22   b ,  22   c ,  22   d , has a trapezoidal cross-sectional shape. Each balloon may have one or more internal chambers and each has the ability to be expanded to a plurality of working sizes upon the application of given pressures through its respective inflation channel without bursting.  
         [0035]     Balloons suitable for use in the present invention may be made using compliant materials, non-compliant materials, or a combination of complaint and non-compliant materials. As is well known to those skilled in the art, balloons made solely from compliant materials (e.g., polyethylene, polyolefin, polyurethane) expand and stretch with increasing pressure within the balloon, while balloons made solely from non-compliant materials remain at a pre-selected diameter as the internal balloon pressure increases beyond that required to fully inflate the balloon.  
         [0036]     As will be readily evident to those skilled in the art, by inflating and deflating the various balloons  22   a ,  22   b ,  22   c ,  22   d , the distal end  14  of the tubular member  12  of the endoscope shaft  10  can be moved either left or right, up or down, clockwise or counter-clockwise, thereby providing the operator with the ability to finely adjust the position of the distal end  14  of the tubular member  12  beyond that which is achievable by the angling controls in the control head of the endoscope.  
         [0037]     The construction of the remaining parts or components of the endoscope shaft  10  (i.e., tubular member  12 , interior optical channel  16 , interior inflation channels, functional channels  18   a ,  18   b ,  18   c ,  18   d , inflation/deflation control means), as well as, other parts or components of the endoscope (e.g., the control head, the light source(s), image guides or image-capturing/compressing/recording means, air/water/suction supply, etc.) are well-known in the art and do not form a part of this invention.  
         [0038]     While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the breadth and scope of the present invention should not be limited by any of the exemplary embodiments.