Abstract:
A brush-like element can be housed within a vacuum sleeve for advancement through a natural orifice to tissue, such as an appendix or gall bladder or diverticulum, to be inverted pursuant to resolution of a malady associated with the tissue. The brush is advanced out of the sleeve into the tissue and if desired rotated, and vacuum may also be drawn through the sleeve to further grip the tissue. The brush is then retracted into the sleeve to clamp or trap the tissue for inversion or other manipulation.

Description:
[0001]    This application claims priority from U.S. provisional patent application 60/956,089, filed Aug. 15, 2007. 
     
    
     FIELD OF THE INVENTION  
       [0002]    The present application relates generally to brush devices for grasping and manipulating tissue particularly for natural orifice surgery. 
       BACKGROUND OF THE INVENTION  
       [0003]    The present assignee&#39;s U.S. patent publication no. 2007/0225734 and U.S. patent application Ser. No. 11/788,597, both of which are incorporated herein by reference, disclose various natural orifice surgery systems and methods for resolving maladies such as diverticulosis and appendicitis and for removing organs such as the gall bladder. The present application is directed to structures and methods for inverting tissue particularly in connection with natural orifice surgery to facilitate the resolution of the tissue. 
       SUMMARY OF THE INVENTION 
       [0004]    An apparatus includes a tissue gripping element housed within a tubular member for advancement through a natural orifice to tissue to be inverted pursuant to resolution of a malady associated with the tissue. The tissue gripping element is advanceable out of the tubular member into the tissue to grip the tissue and is retractable into the tubular member to grip the tissue for manipulation of the tissue. The tissue gripping element includes plural discrete gripping points. 
         [0005]    In some embodiments the gripping points can be established by ends of respective bristles oriented generally radially relative to the tubular member. In other embodiments the gripping points are established by ends of respective teeth. The teeth may be arranged on a proximal-facing transverse surface, and plural tubular member teeth can be arranged on a distal-facing transverse surface of the tubular member. The tissue gripping element is distally advanceable relative to the tubular member to space the surfaces from each other and is proximally retractable relative to the tubular member to trap tissue between the surfaces. 
         [0006]    The tubular member may establish a vacuum lumen through which a vacuum can be drawn to attract tissue toward the tubular member. Tissue can be attracted toward an open distal end of the tubular member when a vacuum is drawn in the tubular member, and in some embodiments tissue can also be attracted toward plural vacuum openings formed in the tubular member when a vacuum is drawn in the tubular member. A cover tube may be advanced over the tubular member to block at least some of the vacuum openings. 
         [0007]    If desired, the tissue gripping element can be rotatable relative to the tubular member. Also, a smooth rounded atraumatic surface can be provided for establishing a distal end of the tissue gripping element. 
         [0008]    In another aspect, a method includes establishing a retracted configuration of a tissue manipulation device in which a tissue gripping element is retracted entirely within a sleeve. The tissue gripping element includes plural discrete gripping points. The method also includes providing instructions to advance the tissue manipulation device through a natural body orifice to tissue to be manipulated, providing instructions to advance the tissue gripping element out of the sleeve, and providing instructions to manipulate the tissue gripping element to grip tissue. Instructions to retract the tissue gripping element toward the sleeve can also be provided. 
         [0009]    In another aspect, a system includes a delivery tube advanceable into a natural body orifice toward tissue to be manipulated and an elongated control rod extending from a proximal end of the tube and manipulable by a person. A tissue gripping element is coupled to the control rod and is advanceable out of a distal end of the delivery tube. The gripping element includes plural individual grippers configured to engage tissue and thereby provide a means for manipulating the tissue by manipulating the control rod. 
         [0010]    The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which: 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a perspective partially schematic view of a tissue inversion apparatus, with portions broken away; 
           [0012]      FIG. 2  is a perspective view of the distal end of an alternate tissue inversion apparatus in the extended position; 
           [0013]      FIG. 3  is a perspective view of the distal end of a tissue inversion apparatus in the housed position for advancing the brush toward tissue to be inverted; 
           [0014]      FIG. 4  is a perspective view of the distal end of the tissue inversion apparatus of  FIG. 3 , with the brush in the extended position in tissue to be inverted and after a vacuum has been established; 
           [0015]      FIG. 5  is a perspective view of the distal end of the tissue inversion apparatus of  FIG. 4 , with the brush retracted part way back into the sleeve to trap tissue; 
           [0016]      FIGS. 6-8  are perspective views of the distal segments of non-limiting implementations of brush inversion apparatus; 
           [0017]      FIGS. 9-12  are schematic diagrams of the distal portion of an alternate tissue inversion apparatus showing how tissue is clamped between opposed jagged surfaces; and 
           [0018]      FIG. 13  is a perspective view of the distal segment of yet another non-limiting implementation of brush inversion apparatus. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0019]    Referring initially to  FIG. 1 , a system is shown, generally designated  10 , that includes a flexible elongated hollow sleeve-like delivery tube  12  that is advanceable into a natural body orifice such as the mouth or anus toward tissue to be manipulated. If desired, at least a distal sleeve  14  of the delivery tube  12  may be configured with plural vacuum openings  16  such as round holes, elongated slots, etc. as more fully disclosed below. The openings  16  may establish a spiral pattern as shown. 
         [0020]    As shown in  FIG. 1 , the delivery tube  12  may terminate proximally at a “wye” connector  18 , one branch of which supports a manipulable elongated control rod  20  around which a collet  22  may be tightened to prevent movement of the rod  20  relative to the “wye”  18 . The other branch of the “wye” forms a lumen that may be connected to a pressure source  24 . The pressure source  24  may be a negative pressure source (a vacuum) or a positive pressure source (such as a fluid pump or pressurized fluid source) for establishing a desired pressure within the delivery tube  12 . 
         [0021]    As also shown in  FIG. 1 , a tissue gripping element  26  is coupled to the control rod  20  and is advanceable out of an open distal end  28  of the delivery tube  12 . In the embodiment shown in  FIG. 1 , the tissue gripping element  28  includes plural individual, discrete grippers  30  such as brush bristles that are configured to engage tissue and thereby provide a means for manipulating the tissue by manipulating the control rod  20 . At least some of the bristles may be oriented generally radially relative to the delivery tube  12  as shown. If desired, a cover tube  32  may be advanceable over the delivery tube to block at least some of the vacuum openings  16 . 
         [0022]      FIG. 2  shows that in some implementations, a smooth rounded atraumatic surface  34  may be provided on the distal end of the tissue gripping element  26  to facilitate advancing the gripping element  26  into tissue atraumatically to the tissue. 
         [0023]      FIGS. 3-5  illustrate various operational configurations of the system  10 . In  FIG. 3 , the gripping element  26  is retracted within the sleeve  14  with no part of the gripping element  26  extended distally beyond the open distal end of the sleeve. In this configuration, the sleeve  14  with gripping element  26  may be advanced through the natural orifice to the tissue sought to be manipulated, such as, e.g., the appendix, gall bladder, diverticulum, etc. 
         [0024]    Once the sleeve  14  is juxtaposed with the tissue, as shown in  FIG. 4  the gripping element  26  is advanced by means of the control rod  20  out of the distal end of the sleeve  14  and into tissue  36 , typically into a void that is naturally formed by the tissue. If desired, the interior of the sleeve  14  may be evacuated by appropriately operating the source  24  of pressure shown in  FIG. 1  to attract the tissue  36  toward the sleeve  14 , including toward the vacuum openings  16  and the open distal end of the sleeve. Evacuation also causes the tissue to collapse onto the grippers  30 , with the ends of a multitude of grippers establishing anchor points to the tissue. In addition to vacuum or alternatively, the gripping element  26  may be rotated to tighten the tissue onto the grippers  30 . In any case, adequate time may be allocated to permit the vacuum to collapse the tissue. 
         [0025]    By providing multiple points of contact (e.g., multiple bristles), less damage to the tissue is effected during manipulation and furthermore, minimally traumatic disengagement of the gripping element  26  with the tissue should such become necessary is facilitated. To disengage the tissue, a positive pressure source may be actuated to pressurize the interior of the sleeve  14  and thereby urge tissue away from the sleeve and bristles. 
         [0026]    As shown in  FIG. 5  the gripping element  26  may be retracted proximally relative to the sleeve  14  to trap or wedge the tissue  36  between the grippers  30  and the interior of the sleeve  14  as shown. With the tissue thus firmly gripped, it may be manipulated as desired, e.g., the tissue may be inverted, moved, retracted, resected, etc. as appropriate for the particular procedure. Instructions may be provided on, e.g., a substrate to effect the above steps. 
         [0027]      FIG. 6  shows that in one non-limiting implementation, a brush  40  with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube  42  formed with plural vacuum holes  44 . The diameter “D 1 ” of the brush  40  may be 2.3 mm and the brush may be 20 mm in length. The brush  40  may slide within the tube  42  or it may be stationarily engaged with the tube  42 , in which case a cover tube such as the cover tube  32  shown in  FIG. 1  that can be made of, e.g., Teflon™ can be used to enclose the brush  40  during delivery to the tissue site. 
         [0028]      FIG. 7  shows that in another non-limiting implementation, a brush  46  with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube  48  formed with plural elongated vacuum notches  50  that do not extend completely through the wall of the tube  48  but that terminate in respective vacuum holes  52  that do extend through the wall of the tube. The notches  50  with holes  52  may be formed in two lines on opposite sides of the tube. The diameter “D 2 ” of the brush  46  may be 2.5 mm and the brush may be 25 mm in length. The brush  46  may slide within the tube  48  or it may be stationarily engaged with the tube  48 , in which case a cover tube such as the cover tube  32  shown in  FIG. 1  that can be made of, e.g., Pebax™ can be used to enclose the brush  40  during delivery to the tissue site. 
         [0029]      FIG. 8  shows that in another non-limiting implementation, a brush  54  with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube  56  formed with plural elongated vacuum notches  58  that do not extend completely through the wall of the tube  56  but that terminate in respective vacuum holes  60  that do extend through the wall of the tube. The notches  56  with holes  60  may be formed in two lines on opposite sides of the tube, and additional holes  62  may be formed without notches in a spiral pattern as shown. Tape may be used to cover holes that are not desired to be used to establish a vacuum. The brush can be exposed at various lengths relative to the tube. The hole pattern inhibits tissue slippage to minimize unwanted twisting of the appendix. 
         [0030]      FIGS. 9-12  show an alternate system  100  in which a gripping element  102  is slidably engaged with a delivery tube  104  that may be formed with vacuum openings  106  in accordance with disclosure above. As shown, the gripping element  102  includes a rounded smooth atraumatic distal end  108  defining a flat disc-like proximal-facing surface formed with plural teeth  110 . Also, the distal end of the tube  104  defines a distal-facing flat disc-like surface formed with plural tube teeth  112 . 
         [0031]    With this structure, the system  100  is advanced through a natural orifice with the gripping element  102  retracted into the tube  104  ( FIG. 9 ) such that the teeth  110 ,  112  mesh, or alternatively are in substantial contact with each other. When positioned in the target tissue the gripping element  102  is advanced away from the tube  104  ( FIG. 10 ) into the tissue and then vacuum is established in the tube  104  ( FIG. 11 ) to attract tissue into the space between the teeth  110 ,  112 . The gripping element  102  is then retracted proximally relative to the tube  104  ( FIG. 12 ) to trap tissue between the teeth  110 ,  112 . The shaft of the gripping element  102  may further include bristles in accordance with the disclosure above in addition to the structure shown in  FIGS. 9-12 . 
         [0032]      FIG. 13  illustrates a gripping element  200  with bristles  202  and atraumatic distal tip  204  that may be slidably engaged with a sleeve  206 . The sleeve  206  may be formed with vacuum openings  208 . A cover tube  210  such as the cover tube  32  shown in  FIG. 1  can be used to enclose the bristles and/or to cover the vacuum openings  208 . 
         [0033]    While the particular BRUSH DEVICE FOR GRASPING AND MANIPULATING TISSUE are herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.