Abstract:
The invention is incorporated into a tissue removal and manipulation device for vaginal hysterectomies and related surgeries. The present invention solves the suturing problem of the prior art devices by providing a device that not only can manipulate the uterus during surgery but remove the uterus without the need for suturing.

Description:
[0001]    This is a continuation application of application Ser. No. 13/248,194 filed Sep. 29, 2011. This application incorporates by reference application Ser. No. 13/248,194 in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to a surgical device for use in connection with vaginal related surgeries, and more specifically to a surgical device for use in connection with a vaginal hysterectomy. 
         [0004]    2. Discussion of the Related Art 
         [0005]    The surgical field is always searching for ways to improve patient outcome. A few of the common ways to improve patient outcome include: (1) employing techniques that shorten the length of surgery, (2) employing techniques that make the surgery less traumatic on the patient, and (3) employing techniques that do both. 
         [0006]    A hysterectomy is the surgical removal of the uterus and is the second most common type of major surgery performed on women of childbearing age. Advances in laparoscopic surgical equipment have enabled surgeons to remove the uterus and/or ovaries laparoscopically. While the advantages of a laparoscopic hysterectomy or a laparoscopically assisted vaginal hysterectomy (LAVH) are well-known, a considerable amount of surgical time is spent securing sutures to the uterus for the purpose of removing the uterus at a later stage. This time lengthens the surgery and increases trauma on the patient as a result of the lengthened surgery. What is needed is a uterine manipulator that improves patient outcome by reducing surgical time and patient trauma by eliminating the need for suturing the uterus in order to facilitate later removal. 
         [0007]    A number of devices have been developed to improve vaginal hysterectomy and related procedures. Prior devices have been disclosed in the following United States patents: U.S. Pat. No. 5,951,465 (Schiff et al), U.S. Pat. No. 5,394,863 (Stanford, et al), U.S. Pat. No. 3,796,214 (Davis), U.S. Pat. No. 5,928,249 (Saadat et al.), and U.S. Pat. No. 5,209,754(Ahluwalia). None, however, disclose the aspects of this present invention. 
       SUMMARY OF THE INVENTION 
       [0008]    The invention is summarized below only for purposes of introducing embodiments of the invention. The ultimate scope of the invention is to be limited only to the claims that follow the specification. 
         [0009]    Generally, the present invention is incorporated into a tissue removal and manipulation device for vaginal hysterectomies and related surgeries. The present invention solves the suturing problem of the prior art devices by providing a device that not only can manipulate the uterus during surgery but can remove the uterus without the need for suturing. 
         [0010]    The present invention is incorporated in a device  10  for the manipulation of the uterus that includes an elongated shaft  20 , a retractable barb  30 , a cervical cup  40 , and an expandable balloon  50 . The retractable barb  30  is located close enough to the distal end  22  of the device  10  so that after completing the colpotomy stage of a hysterectomy, the retractable barb  30  can be deployed inside the uterus. Once deployed inside the uterus, the cervix can be compressed between the retractable barbs  30  and the cervical cup  40  prior to removal of the device  10 . Thus, when device  10  is removed post-colpotomy, the compression on the cervix enables the uterus to be removed as one unit with the device  10 . 
         [0011]    To use device  10 , the following steps are preferred: (1) dilate the cervix to fit the distal end  22  of device  10 ; (2) introduce the distal end  22  of device  10  to the uterus so that the retractable barb  30  passes the cervix; (3) expand the balloon  50  inside the uterus to provide some resistance against the cervix, (4) slide the cervical cup  40  down over the cervix and secure cup  40  with the anti-backslide collar  52  to keep the cervical cup  40  pressed against the cervix to aid in manipulating the uterus as needed during surgery, (5) activate the circumferential illuminator to locate fornix and assist with surgical colpotomy, (6) (post-colpotomy) deploy barbs  30  and retract elongated shaft while keeping cervical cup  40  over the cervix in order to secure uterus to device  10 , and (7) remove the device  10  with the uterus as one unit. 
         [0012]    It is an object of the invention to eliminate the cervix suturing step for hysterectomy surgeries and related surgeries by replacing the suturing step with at least one retractable barb  30  in order to remove the uterus. 
         [0013]    It is an object of the invention to use a retractable barb to make it easier, less traumatic, and quicker to extract the uterus during a hysterectomy surgery. 
         [0014]    It is an object of the invention to give a surgeon a visual guide to colpotomy for laparoscopic hysterectomy. 
         [0015]    It is an object of the invention to make colpotomy more accurate and to make it easier to recognize the tissue to be cut. 
     
    
     
       DESCRIPTION OF THE DRAWINGS OF PREFERRED EMBODIMENT 
         [0016]      FIG. 1  illustrates perspective view of a basic embodiment of the device  10 . 
           [0017]      FIG. 2  illustrates a side view of a basic embodiment of the device  10 . 
           [0018]      FIG. 3  illustrates a front view of the cervical cup  40 . 
           [0019]      FIG. 4  illustrates a side view of the cervical cup  40  with the circumference of the open end illuminated with led lights. 
           [0020]      FIG. 5A  illustrates a side view the preferred embodiment of the handle and the pull string to deploy the barb. 
           [0021]      FIG. 5B  illustrates a side interior view of the preferred embodiment of the handle and the pull string moving the barb  20  into the deployed position. 
           [0022]      FIG. 6A  illustrates a cut view of the elongated shaft at the barb location with the barbs in the first position  60  (not deployed). 
           [0023]      FIG. 6B  illustrates a cut view of the elongated shaft at the barb location with the barbs in the second position  70  (deployed). 
           [0024]      FIG. 7A  illustrates cut A-A from  FIG. 6A  with the barbs in the first position (not deployed). 
           [0025]      FIG. 7B  illustrates cut B-B from  FIG. 6B  with the barbs in the second position (deployed). 
           [0026]      FIG. 8  illustrates an embodiment of the retractable barb  30   
           [0027]      FIG. 9A  illustrates an embodiment of the expandable balloon  50 . 
           [0028]      FIG. 9B  illustrates the expandable balloon  50  of  FIG. 9A  in an expanded position. 
           [0029]      FIG. 9C  illustrates an end view of  FIG. 9A . 
           [0030]      FIG. 10A  illustrates another embodiment of the expandable balloon  50 . 
           [0031]      FIG. 10B  illustrates the expandable balloon  50  of  FIG. 10A  in an expanded position. 
           [0032]      FIG. 10C  an isometric view of a paddle scoop embodiment. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENT 
       [0033]    The descriptions below are merely illustrative of the presently preferred embodiments of the invention and no limitations are intended to the detail of construction or design herein shown other than as defined in the appended claims. 
         [0034]    The present invention is incorporated in a device  10  for the manipulation of the uterus that preferably includes an elongated shaft  20 , a retractable barb  30 , and a cervical cup  40 . Most preferably, the device  10  includes a plurality of retractable barbs  30 , an illuminable ring  42 , an expandable balloon  50  and an anti-backslide collar  52 . An overview of the preferred steps is as follows: the cervix is dilated to fit the distal end  22  of device  10 ; the distal end  22  of device  10  is introduced to the uterus so that the retractable barb  30  passes through to the inside of the cervix; the balloon  50  is expanded the uterus to provide some resistance against the cervix; the cervical cup  40  is moved down onto the cervix and the cervical cup  40  is secured against back-sliding with the anti-backslide collar  52  to keep the cervical cup  40  pressed against the cervix; the circumferential illuminator is turned on to assist in locating the fornix and assist with surgical colpotomy; post-colpotomy, the barbs  30  are deployed while keeping cervical cup  40  over the cervix compressing the cervix between the cup  40  and the barbs  30  in order to secure uterus to device  10 ; and the device  10  is removed with the uterus as one unit. 
         [0035]    More specifically, as shown in  FIG. 1 , the elongated shaft  20  has a distal end  22 , a proximal end  24  and an outer surface  26 . The preferred elongated shaft  20  houses a central shaft  80  as shown in  FIGS. 6A-7B  and discussed in more detail below. The elongated shaft  20  has a plurality of holes to permit the tissue-hooking segment  34  of a retractable barb  30  to protrude. 
         [0036]    While at least one retractable barb  30  is required, it is preferable to have a plurality of retractable barbs  30 .  FIGS. 6A and 6B  illustrate the presently preferred embodiment of four retractable barbs  30 . As illustrated, the preferred retractable barbs  30  should have at least two positions: a first position  60  where the barb  30  is flush or below with the outer surface  26  of the elongated shaft  20 , and a second position  70  where the barb  30  projects beyond the outer surface  26  of the shaft  20 . 
         [0037]      FIG. 6A  shows the retractable barbs  30  in the first position  60  (or the retracted position). As shown in  FIG. 6A , the retractable barb  30  is completely inside the elongated shaft  20  and below its outer surface  26 .  FIG. 6B  shows the retractable barbs  20  in the second position  70  (or the deployed position). As shown in  FIG. 6B , the retractable barbs  30  extend beyond the outer surface  26  of the elongated shaft  20 . 
         [0038]    Turning to  FIG. 7A and 7B , it is preferred that each retractable barb  30  slide lengthwise within the elongated shaft  20 . While there are a variety of ways to accomplish this, it is presently preferred that the retractable barbs  30  slide in opposing slots  62 , located in the space between the outside of central shaft  80  and the inside surface of the elongated shaft  20 . The slots  62  can be created by securing a length of channel to the inner and outer walls respectively as shown in  FIGS. 6A-7B . 
         [0039]      FIGS. 6A-7B  also illustrate the preferred embodiment of the interior of the elongated shaft  20 . In addition to the central shaft  80 , a pull-able cord  82  is also housed inside the elongated shaft  20 . The cord  82  can be made from a variety of suitable materials known in the art like cotton, metal, nylon or similar flexible tension-bearing material. One end of the cord  82  is accessible to the user at the proximal end  24  of the device  10 . The other end of cord  82  is connected to a barb  30 . While the connection can be achieved in a variety of ways, the preferred connection is to thread cord  82  a through a hole  32  and tying it off. 
         [0040]      FIG. 8  illustrates the preferred embodiment of the barb  20 . The preferred barb  30  is a piece of metal bent back upon itself to create a tissue-hooking segment  34  and a shaft-sliding segment  36 , the shaft-sliding segment  36  having hole  32  for securing cord  82 . The stiffness of the metal and the partial bend impart a spring characteristic on the tissue-hooking segment  34 . In the first position  60 , the tissue-hooking segment  34  is forward of barb-deployment portal  28  on elongated shaft  20 . The wall of the elongated shaft  20  prevents the tissue-hooking segment  34  from springing outward and deploying prematurely. 
         [0041]    After the colpotomy is complete the tissue-hooking segment  34  is deployed by pulling on the cord  82 , preferably using a deployment ring  84  on a handle  86 . Pulling on the ring  84  slides the retractable barb  30  along the opposing slots  62  in the direction of the proximal end  24 . When the tissue hooking segment  34  reaches the barb-deployment portal  28 , the tissue-hooking segment  34  springs outward and extends through the portal  28  into the second position  70 . Inside the handle in line with the cable is a cord clamp  88  that prevents the barb  30  from retracting. 
         [0042]    As shown in  FIG. 6B , in the second position  70 , the tissue-hooking segment  34  extends beyond the outer surface  26  of the elongated shaft  20  and forms an acute angle α with shaft-sliding segment  36 . Because the tissue-hooking segment  34  will be angled toward the cervix in the second position  70 , the tissue-hooking segment  34 , once deployed, will engage the inner orifice of the cervix as the device  10  is removed from the uterus. 
         [0043]    A cervical cup  40 , preferably in the shape of a hollow truncated cone, is shown in  FIGS. 1-4 . The preferred cervical cup  40  has an open top and a closed bottom with a bottom cup hole  44  through which the elongated shaft  20  can be slidably inserted through. The cervical cup  40  is oriented on the elongate shaft to oppose the barb when the barb is in the second position  70 . 
         [0044]    Also shown in  FIGS. 1-2  is an anti-backslide collar  52 . The purpose of anti-backslide collar  52  is to keep the cervical cup from backsliding on the elongated shaft  20  (i.e., sliding toward the proximal end  24 ) once the cervical cup  40  is placed on the cervix. The anti-backslide collar  52  can be made in a variety of ways. It is preferred to make anti-backslide collar  52  from a sleeve of hard plastic so it can slide on the elongated shaft  20 . It is also preferred to that the anti-backslide collar  52  have a set screw  54  to set the collar relative to the elongated shaft once the cervical cup  40  is in position on the cervix. 
         [0045]    As shown in  FIGS. 3 and 4 , it is preferred that at least the circumferential rim  48  of the open top of the cervical cup  40  be capable of illumination. Illumination can be accomplished by embedding LED lights around the circumference of the open top and connecting the lights to an energy source, such as battery  58 , via cable  56 . Other ways to illuminate the circumferential ring, such as fiber optics, are known in the art and can be suitable. 
         [0046]    The purpose of illuminating the circumferential rim  48  is to eliminate the need for the surgeon to estimate where the fornix is located by feel or pressure from the cervical cup  40 . An illuminated circumferential rim  48  creates a halo effect that will show through tissue, such as around the fornix when the cervical cup  40  is engaged with the cervix at its fornix. The halo effect will show through and illuminate the fornix viewed from the interior of the uterus, laparoscopically or otherwise. This will enable the surgeon to cut desired tissue more efficiently and more accurately. 
         [0047]    Another preferred option is to include a balloon on the distal end  22  of the elongated shaft  20 . Attaching a balloon to the distal end  22  of the elongated shaft is known in the art. See, e.g., U.S. Pat. No. 5,209,754 (Ahluwalia) at 2:55-3:17. Although there are many ways to make the expandable balloon element, it is presently preferred to inflate using air or saline from a syringe, a supply line  53  and a one-way valve  51  (e.g., a luer-type valve). The supply line  53  can run from from the syringe to the balloon  50  through the elongated shaft  20  or the central shaft  80 . 
         [0048]    What was not known prior to this invention, however, is to attach a balloon not having a smooth surface. A balloon with a smooth surface can sometimes slip during manipulation. For this invention, it is preferred to use a balloon having a non-smooth surface in order to better engage the inner wall of the uterus. Most preferably the balloon  50  has molded knobs  90  or raised sections  92  that emerge when the balloon  50  is inflated as shown in  FIGS. 9A-10C . The knobs  90  or raised sections  92  of the balloon engage the inner wall of the uterus to counter-act slippage. While the knobs  90  or raised sections  92  can take a variety of shapes, the preferred shape of the raised section  92  is a “paddle scoop” shape as oriented and shown in  FIGS. 10A-C . 
         [0049]    In operation, the following steps are preferred:
       a. Dilate the cervix to fit the distal end  22  of device  10 ;   b. Introduce the distal end  22  of device  10  to the uterus so that the retractable barb  30  passes the cervix;   c. Inflate the expandable balloon  50 ;   d. Slide the cervical cup  40  down over the cervix and secure the cup with the anti-backslide collar  52 ;   e. Activate the circumferential illuminator to locate fornix and assist surgical procedure;   f. Complete colpotomy;   g. Deploy barbs  30 ;   h. With barbs  30  deployed, which keeps cervical cup  40  over the cervix in order to secure uterus to device  10 , retract elongated shaft  20 ; and,   i. Remove the device  10  with the uterus as one unit.       
 
         [0059]    While the device of the present invention has been described in connection with a particular type of surgical procedure, it should be understood that this instrument may be used in other situations where deliberate directing, movement and visualization of the uterus is required. Additionally, it is understood that various changes can be made by one possessing ordinary skill in the art which would be beyond the scope of protection. Although the invention has been described in detail with reference to one or more particular preferred embodiments, persons possessing ordinary skill in the art to which this invention pertains will appreciate that various modifications and enhancements may be made without departing from the spirit and scope of the claims that follow.