Patent Publication Number: US-2022233211-A1

Title: Curette and use thereof

Description:
INTRODUCTION 
     Physicians do not have a visual reference of a curette when they perform a suction dilation and curettage. The only reference that confirms success of the procedure is when the physician visually sees endometrial material evacuating. 
     The curette can cause minor and even major damage to the uterine wall. 
     STATEMENTS OF INVENTION 
     The invention provides an echogenic curette for carrying out a suction dilation and curettage which allows the physician view the curette and the pathology they want to remove, and use that to guide them. The echogenic curette is visible on an ultrasonic device used outside the body. 
     The invention provides a method for carrying out a suction dilation and curettage comprising the steps of:
         deploying an echogenic suction curette into the vagina;   inserting the echogenic curette into the cervix under ultrasound guidance;   performing uterine evacuation under ultrasound guidance; and   withdrawing the echogenic curette.       

     The method may comprise the step of deploying ultrasound abdominally or vaginally. 
     Complete emptying of the uterus may be confirmed using ultrasound imaging. 
     In some cases the method comprises the steps of:
         inserting a retractor into the vagina; and   stabilising the cervix with a cervical stabiliser prior to deploying the echogenic suction curette into the vagina;   removing the cervical stabilizer; and   removing the vaginal retractor after withdrawal of the echogenic curette.       

     The method may comprise the step, prior to insertion of the retractor, of examining the cervix and the uterus bimanually. 
     The method may comprise dilating the cervix to a desired diameter. 
     The invention also provides a suction curette comprising a shaft having a distal inlet end with an opening through which material is drawn into the shaft and a proximal discharge outlet end, wherein at least a portion of the curette is echogenic. 
     In one case at least the distal inlet end is echogenic. 
     In some cases the curette comprises a lip extending around the distal inlet and the lip is echogenic. 
     In some cases at least a portion of the shaft is echogenic. 
     The curette may comprise echogenic features. 
     In some cases the echogenic features comprise sharp corners which may be cut into the curette, for example, by etching. 
     The echogenic features may comprise voids in the curette. In some cases at least some of the voids are at least partially filled with an echogenic material such as a gas. 
     In some cases the features comprise ribs or rods extending along the curette. 
     The curette may comprise a main body portion and a distal end portion which is bonded to, or integrally formed with, the main body portion. The distal end portion in some cases is overmoulded to the main body portion. The distal end portion may comprise or consist of an echogenic material. 
     The curette in some cases may be rendered echogenic by a polystyrene material. 
     The invention also provides a device for use in a medical procedure wherein at least a portion of the device is rendered echogenic by a polystyrene material. 
     Other aspects and preferred embodiments of the invention are defined and described in the other claims set out below. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be more clearly understood from the following description thereof given by way of example only with reference to the accompanying drawings, in which : 
         FIG. 1  is a diagram illustrating the step of bi-manual examination of the cervix and uterus; 
         FIG. 2  is a diagram illustrating the placement of a vaginal retractor, for example using a speculum; 
         FIG. 3  is a diagram illustrating stabilisation of the cervix, for example, using tenaculum; 
         FIG. 4  is a diagram illustrating deployment of ultrasound abdominally; 
         FIG. 5  is a diagram illustrating insertion of an echogenic curette into the cervix under ultrasound guidance; 
         FIGS. 6 to 10  illustrate a curette having echogenic features; 
         FIGS. 11 to 13  are views of a curette with an echogenic distal tip; 
         FIGS. 14 to 17  are views of another curette with an echogenic distal tip; 
         FIGS. 18 to 20  are images of a curette with an echogenic distal tip and echogenic features along the shaft of the curette; 
         FIGS. 21 to 23  are views of a curette with echogenic features at the distal tip defining the inlet opening; 
         FIGS. 24 to 35  are views of a curette with alternative echogenic distal tips; 
         FIGS. 36 to 39  are images of another curette with echogenic features in the form of voids; 
         FIGS. 40 and 41  are ultrasound images of a curette of  FIGS. 36 to 39  in use with empty voids ( FIG. 40 ) or voids filled with fluid ( FIG. 41 ); 
         FIGS. 42 to 44  are images of a curette with echogenic features etched or moulded therein or thereon; 
         FIGS. 45 and 46  illustrate another curette with echogenic features extending along the shaft; 
         FIGS. 47 to 50  are images of a curette with elongate voids in the form of ribs or rods extending along the shaft; 
         FIGS. 51 and 52  are views similar to  FIGS. 47 to 50  with the elongate ribs or rods filled with a fluid; 
         FIGS. 53 to 56  are views of an echogenic curette similar to  FIGS. 47 to 52  with ribs or rods having sharp corners; 
         FIGS. 57 to 60  are images of a further curette with an overmoulded distal tip of an echogenic material such as polystyrene; 
         FIGS. 61 to 63  are views of another curette with a rigid foam distal tip; 
         FIGS. 64 and 65  are views of a curette with bubbles extending through the length of the curette; 
         FIG. 66  is a view of the curette of  FIGS. 64 and 65 , in use; 
         FIGS. 67 and 68  are views of a curette with a spark pattern along the curette; 
         FIG. 69  is an X-ray of the curette of  FIG. 68 , in use; 
         FIGS. 70 to 77  are views of curettes with various spark patterns; 
         FIGS. 78 to 84  are views of a curette with a spiral rib; 
         FIGS. 85 to 91  are views of a curette with a flat square rib; 
         FIGS. 92 to 98  are views of a curette with a higher frequency of ribs; 
         FIGS. 99 to 105  are views of a curette with cut lines; 
         FIGS. 106 to 112  are views of a curette with a flat square spiral groove; 
         FIGS. 113 to 119  are views of a curette with a V-shaped spiral groove; 
         FIGS. 120 to 127  are views of a curette with spiral V-shaped grooves turning in opposite directions; 
         FIGS. 128 to 134  are views of a curette with rounded ring ribs; and 
         FIGS. 135 to 140  are views of a curette with a greater number of rounded ribs. 
     
    
    
     DETAILED DESCRIPTION 
     A method for carrying out a suction dilation and curettage comprises inserting a retractor into the vagina and stabilising the cervix with a cervical stabiliser. An echogenic suction curette is then deployed and inserted under ultrasound guidance. A uterine evacuation is performed under ultrasound guidance. The echogenic curette is then withdrawn, the cervical stabiliser and the retractor are removed. Ultrasound is deployed extra abdominally or vaginally during the procedure and emptying of the uterus is confirmed using ultrasound imaging. 
       FIG. 1  illustrates the step of bi-manual examination of the cervix and uterus. 
       FIG. 2  illustrates the placement of a vaginal retractor  1 , for example, using a speculum. 
       FIG. 3  illustrates stabilisation of the cervix, for example, using a tenaculum  2 . 
       FIG. 4  illustrates deployment of ultrasound  3  abdominally. Ultrasound may also be deployed vaginally. 
       FIG. 5  illustrates insertion of an echogenic curette  5  into the cervix under ultrasound guidance. 
     To enhance echogenicity of the curette a number of features may be employed either individually or in any suitable combination. 
     The curette may have empty cavities and/or bubbles which are echo-dense or echo-enhanced under ultrasound. Fluid filled cavities appear black under ultrasound as they offer no resistance to sound-waves. Under ultrasound we have found that polystyrene appears as an echo-enhanced scatter without causing heavy shadowing. An overmoulded component may be mixed into the rigid clear material typically in the form of flakes or balls. The shaft may be a rigid clear material such as polycarbonate or the like. Closed cell foam may be used as it appears as echo-dense or echo-enhanced under ultrasound, similar to the empty cavities. Surface finishes such as moulded in features with sharp edges may be used to cause scatter in the ultrasound which appear echo-dense or echo-enhanced. 
     The curette, in some cases, may comprise a polymeric material such as polycarbonate, polyethylene or polypropylene. Polystyrene may be incorporated to render the curette echogenic. 
     In some cases polystyrene, for example in the form of beads is embedded in polycarbonate, polyethylene or polypropylene. 
     Cavities or bubbles may be formed in or incorporated into the curette using techniques such as described in U.S. Pat. No. 5,160,674, the entire contents of which are incorporated herein by reference. 
     Referring to  FIGS. 6 to 10  there are illustrated various echogenic curettes  10 ,  11 ,  12 . The black areas  13  on the curettes represent either an echogenic coating or features that allows the ultrasound equipment to see the parts. The markings  13  assist surgeons in seeing the depth and orientation of the curette for the removal of tissue. 
     Referring to  FIGS. 11 to 13 , in this case a curette  20  has a distal tip  21  and the tip profile has a material with more echogenicity than that of the shaft  22  which is overmoulded onto the tip. The tip  21  may, for example, comprise polystyrene or closed cell foam which will contrast to the material of the shaft  22 . The shaft may be of polycarbonate. 
       FIGS. 14 to 17  illustrate a curette  30  comprising a shaft  31  and an overmoulded component  32 . 
       FIGS. 18 to 20  are illustrations of another curette  35  with an overmoulded component which, in this case, comprises elongate ribs  37  that extend along the shaft. 
       FIGS. 21 to 23  illustrate another curette  40  which, in this case, comprises a distal opening  41  with a lip  42  which is rendered echogenic by selecting a suitable material and/or finish. 
       FIGS. 24 to 27  illustrate a further curette  50  which has a lip filled with material such as polystyrene balls  51  or the like which has a different echogenic property to that of the main body of the shaft  52 . The tip may be overmoulded with a suitable shaft material such as polycarbonate. A similar effect may be achieved using a tip of a closed cell material and/or by providing voids in the main body of the curette shaft. 
       FIGS. 28 to 31 and 32 to 35  illustrate other echogenic curette tips  60 . 
       FIGS. 28 to 31  illustrate a curette which is moulded with bubbles focused around the opening of the curette. Alternatively, a separate element with bubbles may be attached/welded/glued/overmoulded onto a main shaft. 
       FIGS. 32 to 35  illustrate a curette which is moulded with a greater concentration of bubbles focused around the head of the curette. Alternatively, a separate element with bubbles may be attached/welded/glued/overmoulded onto a main shaft. 
     Referring to  FIGS. 36 to 39 , in this case voids such as empty spheres  65  may be moulded into the shaft  66  of a curette  67  to enhance echogenicity. Alternatively, at least some of the voids may be filled with a fluid.  FIGS. 40 and 41  illustrate a curette in use with empty voids ( FIG. 40 ) and filled voids ( FIG. 41 ) in the shaft under ultrasound. 
       FIGS. 42 to 44  illustrate curettes  70 ,  71  with various patterns  73  provided in or on the curette. The patterns  73  may be moulded into the curette or may be formed by cutting, such as by etching. The pattern may be of any shape such as those with sharp edges, for example, inverted pyramids or X shapes. In some cases, an echogenic pattern extends over the distal tip of the curette, somewhat like a stripe or a mohawk  75 . 
     Another echogenic pattern  78  in a curette  72  is illustrated in  FIGS. 45 and 46 . The linear shapes extending longitudinally along the shaft of the curette  72  assist in conveying rotation under ultrasound thereby assisting in showing the orientation of the distal opening. 
     Referring to  FIGS. 47 and 48 , there is illustrated a curette  80  with either moulded empty cavities in the shaft, overmoulded echogenic ribs or rods, and/or fluid filled linear cavities  81 .  FIG. 50  illustrates the appearance of the ribs  81  under ultrasound. 
       FIG. 51  illustrates a curette  85  with linear cavities  86  which may be filled with fluid.  FIG. 52  illustrates the appearance of the fluid filled cavities  86  under ultrasound. 
       FIGS. 53 to 55  illustrate curettes  87  similar to those illustrated in  FIG. 47 ,  FIG. 48  and  FIG. 51 . In this case, cavities or ribs  88  have a cross section with sharp corners. The sharp corners may enhance visibility under ultrasound. 
       FIGS. 57 to 60  illustrate further curettes  90  of overmoulded construction comprising a shaft  91  and a distal component  92  of a suitable echogenic material such as polystyrene. 
     We have found that a curette  95  including a rigid foam distal component  96  has excellent echogenic properties. One such curette  95  is illustrated in  FIGS. 61 to 63 . 
       FIGS. 64 and 65  illustrate a curette  100  in which the entire component has bubbles along the length thereof.  FIG. 66  illustrates the curette  100  of  FIGS. 64 and 65 , in use. 
       FIGS. 67 and 68  illustrate a curette  105  with a spark pattern along the length of the curette. Any suitable spark pattern may be used. 
       FIG. 69  illustrates the curette  105  of  FIGS. 67 and 68  in use. The spark finish provides a full visible image of the curette. 
     As illustrated in  FIGS. 70 to 77 , a spark finish may be applied in a number of different patterns  110 ,  115 ,  120 ,  125  at the distal end and/or along at least portion of the length of the curette. 
     Referring to  FIGS. 78 to 84 , there is illustrated a curette  130  with a rib  135 , in this case in a spiral along at least portion of the length of the curette. In one case the rib  135  is of hemispherical shape and may have a diameter of about 1.6 mm. There may be a high or low frequency of revolutions. 
     Referring to  FIGS. 85 to 91  in an alternative a curette  140  has a rib  145  which in this case is rectilinear such as square shaped. Sharp edges aid echogenicity. There may be a high or low frequency of revolutions. 
     Referring to  FIGS. 92 to 98  illustrate a curette  150  with ribs  155  having sharp edges to aid echogenicity. The ribs  155  in this case are in a spiral pattern with a higher frequency than in the curette of  FIGS. 85 to 91 . 
     Referring to  FIGS. 99 to 105 , in this case a curette  160  has cut-in lines or grooves  165 . Again the sharp edges of the long ribs greatly increase the visibility of the device especially as it is being rotated, in use. 
     Referring to  FIGS. 106 to 112 , in this case a curette  170  has a flat rectilinear spiral groove  175  to create sharp edges for enhanced echogenicity. 
     Alternatively, as illustrated in  FIGS. 113 to 119  a curette  180  may have a V shaped spiral groove  185  to create sharp edges for enhanced echogenicity. 
     There may be several grooves and/or ribs along at least portion of the curette. For example, and referring to  FIGS. 120 to 127 , there may be two spiral V grooves  195 ,  196  turning in opposite directions to give a hatched effect for increased visibility of a curette  190 . 
     Referring to  FIGS. 128 to 134 , a curette  200  may have one or more ribs or grooves  205  which extend circumferentially around the curette  200 , for example near the distal end of the curette  200 . These features provide resistance as the curette  200  is being inserted into the cervix. The surgeon feels the resistance reducing as the rings  205  clear the cervix channel. The ribs/grooves  205  also enhance visibility of the curette  200  as it is advanced into the uterus. 
       FIGS. 135 to 140  illustrate a curette  210  with rounded ribs  215  extending along a length of the curette  210 . A higher frequency of ribs enhances visibility. The curette may have a relatively thin wall section with the ribs increasing the outer diameter. This curette may also include bubbles which may be formed as the curette is being formed from a plastics material. The ribs greatly enhance visibility when the curette is rotated. 
     The invention is not limited to the embodiments hereinbefore described which may be varied in detail.