Abstract:
A ligament carrier and suturing device ( 20 ) comprising an elongate shaft member having a distal end and a proximal end. A needle carrier ( 40 ) is located at or adjacent the distal end of said elongate shaft member, said needle carrier comprising a rigid arcuate tooth member and having a first end and a second end and being pivotable at the first end about an axis which lies transverse to the longitudinal axis of the shaft member ( 30 ), the needle carrier adapted to carry a needle ( 80 ) with a suture ( 90 ) attached thereto. A needle capture means ( 100 ) is located on the shaft member, said needle capture device being adapted to engage with and capture needle carried by arcuate tooth. An operating means ( 50 ) coupled to the needle carrier and operable to cause the arcuate tooth member to pivot through an arc so that the needle engages with and is captured by the capture device, the operating means being operable from a location at or adjacent said proximal end of the shaft member.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a surgical device of the type which can be used for inserting sutures within a human or animal body through a confined opening. The invention will be particularly described with reference to a ligature carrier particularly suited for transvaginal sacrospinous colpopexy, but it is to be understood that the device of the invention may be used in other applications. 
       BACKGROUND OF THE INVENTION 
       [0002]    Transvaginal colpopexy has become, in recent years, the preferred treatment of vaginal or vault prolapse or vaginal eversion. This condition tends to be caused by failure of the supporting mechanism of the upper genital tract. Treatment of the condition requires the attachment of the vault to a suitable attachment point within the body, the preferred attachment points being the coccygeus muscle-sacrospinal ligament complex located on either side of the patient&#39;s pelvis. Attachment of each side of the vault to the left and right sacrospinal ligaments has been performed either abdominally or transvaginally, the latter procedure being preferred for reasons such as patient health and wellbeing. 
         [0003]    One problem with performing the procedure transvaginally is that the surgeon is obliged to perform the procedure through the relatively confined vaginal passage. Furthermore, the artificial ligaments need to be attached at some depth within the patient&#39;s body, typically the sacrospinal ligaments, which has meant that some form of elongate ligature carrier and suturing device is required to perform the procedure. 
         [0004]    Various prior art elongate suturing devices have been developed, but for one or other reason the prior art devices currently available are not ideal for performing the procedure. One reason for this is that the sacrospinal ligaments run transverse to the length of the vaginal passage. It is desirable for the sutures to be placed transverse to the length of the ligaments, not parallel to the length of the ligaments, but prior art devices make it technically difficult to place the sutures in this way. 
         [0005]    It is also desirable that, whatever elongate suturing device is used for placing the sutures in the ligaments, the device can effectively perform the procedure on its own, without requiring the assistance of either the surgeon&#39;s finger tips, or another instrument used in conjunction with the suturing device. This is due to the fact that the passage through which the surgeon is working is narrow and if another instrument or the surgeon&#39;s other hand occupies the passage then placing the suture has to be done ‘blind” or by feel, and this makes the procedure far more difficult. If the surgeon is obliged to use two instruments in the suturing procedure then both hands are occupied with suturing, rather than one being free to manipulate or orientate the vaginal passage with retractors. 
         [0006]    Various instruments have been developed specifically for performing the procedure. These include the Veronikis device, described in Obstetrics &amp; Gynecology, Vol 89, No 3, March 1997. This device, however, requires the surgeon to use a suture hook to capture the suture once it has passed through the ligament. Another device, the Miya hook, requires the surgeon to use his or her fingers of the free hand to properly place the suture. A Laurus needle driver has been used to perform the procedure (see Obstetrics &amp; Gynecology, Vol 89, No 1, January 1997). This procedure requires both the surgeon to use his or her fingers in the placement, as well as retrieving the needle after it has passed through the ligament. A further device which is used to perform the procedure is the Shutt Suture Punch, but once again, this device requires the suture to be retrieved after it has passed through the ligament. 
         [0007]    A further problem encountered when performing the procedure is that the coccygeus muscle-sacrospinal ligament complex tends to lie somewhat flat, and therefore does not present well to the suturing device. This is one reason why, with at least some devices, the surgeon needs to use the finger tips of the free hand to press the ligament into a mounded configuration so that the suturing device can take a firm bite of the ligament. Once again, it would be far preferable if the device could function in such a way that the suture could be placed using the device alone, but yet ensure that the suture is passed through sufficient ligament to properly and safely be used to anchor the vault in place. 
         [0008]    Any discussion of documents, publications, acts, devices, substances, articles, materials or the like which is included in the present specification has been done so for the sole purpose so as to provide a contextual basis for the present invention. Any such discussions are not to be understood as admission of subject matter which forms the prior art base, or any part of the common general knowledge of the relevant technical field in relation to the technical field of the present invention to which it extended at the priority date or dates of the present invention. 
       SUMMARY OF THE INVENTION 
       [0009]    According to the invention there is provided a ligament carrier and suturing device comprising:
       an elongate shaft member having a distal end and a proximal end;   a needle carrier located at or adjacent the distal end of said elongate shaft member, said needle carrier comprising a rigid arcuate tooth member and having a first end and a second end and being pivotable at the first end about an axis which lies transverse to the longitudinal axis of the shaft member, the needle carrier adapted to carry on the second end thereof a needle with a suture attached thereto;   a needle capture means located on the shaft member intermediate the distal and proximal ends thereof, said needle capture device being adapted to engage with and capture the needle carried by the arcuate tooth; and   an operating means coupled to the needle carrier and operable to cause the arcuate tooth member to pivot through an arc so that the needle engages with and is captured by the capture device, the operating means being operable from a location at or adjacent said proximal end of the shaft member.       
 
         [0014]    Preferably, the operating means comprises a connecting rod located within a longitudinal passage extending along said shaft member and being engaged with said needle carrier. Preferably the engagement between the connecting rod and the needle carrier comprises a lever arrangement adapted to drive the arcuate tooth through said arc. 
         [0015]    Preferably the needle carrier includes a slot, said connecting rod being slidingly engaged with said slot so as to cause the needle carrier to pivot about the first end as said connecting rod moves longitudinally in relation to said shaft member. Preferably, the needle carrier is biased such that the needle is urged away from said needle capture means, At least a portion of the second end of the needle carrier may be hollow to receive the needle therein and the second end of the needle carrier may include a slot arranged to receive an axially aligned suture connected to the needle such that the suture passes from inside to outside of the needle carrier. 
         [0016]    Preferably a handle means is located at or adjacent the proximal end of said shaft member. The handle means may be coupled to said operating means such that movement of said handle means causes the needle carrier to be advanced towards said needle capture means. The handle means may be arranged such that the device is held and operated by a single hand of a user. Preferably the handle means comprises a moveable lever and a grip, said lever being coupled to said operating means. 
         [0017]    Preferably, the needle capture means is biased such that when the needle is advanced by said needle carrier to said needle capture means the needle capture means engages with the needle automatically, and when the needle carrier is moved away from the needle capture means, the needle disengages from said needle carrier and remains captured. Alternatively, the needle capture means may be manually operable by a user from the proximal end of the shaft member. Preferably the needle capture means captures the needle by engaging with a recess in the needle. The needle capture means may be manually operable from the proximal end of the shaft member by a user to allow the needle to be released from the needle capture means. 
         [0018]    These and further features of the invention will be made apparent from the description of a preferred embodiment of the invention, given below by way of example. In the description reference is made to the accompanying drawings, but the specific features shown in the drawings should not be construed as limiting on the invention. 
         [0019]    Throughout the specification the term “comprise” and variations on this term including “comprising” and “comprises” are to be understood to imply the inclusion of a feature, integer, step or element, and not exclude other features, integers, steps or elements. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0020]    The invention now will be described, by way of example only, and with reference to the accompanying drawings in which: 
           [0021]      FIG. 1  shows diagrammatically the surgical approach which a surgeon may follow for vaginal sacrospinal fixation; 
           [0022]      FIG. 2  shows the manner of attachment of the vagina to the sacrospinous ligaments in sacrospinal fixation; 
           [0023]      FIG. 3  shows a part sectional view of an embodiment of a suturing device according to the present invention prior to a suture being deployed; 
           [0024]      FIG. 4  depicts the suturing device of  FIG. 3  during deployment of the suture; 
           [0025]      FIG. 5  depicts the suturing device of  FIG. 3  and  FIG. 5  after deployment of the suture; 
           [0026]      FIG. 6  shows an enlarged sectional side view of a first embodiment of a needle and capture device according to the present invention; 
           [0027]      FIG. 7  shows an enlarged sectional side view of a second embodiment of a needle and capture device according to the present invention; and 
           [0028]      FIG. 8  shows an enlarged sectional side view of a third embodiment of a needle and capture device according to the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS  
       [0029]    The following description refers to a preferred embodiment of the present invention whereby the present invention is directed to a surgical device of the type for inserting sutures within a human or animal body through a confined opening. Reference in the preferred embodiment below is made with respect to transvaginal sacrospinous colpopexy. 
         [0030]    Referring to  FIG. 1  and  FIG. 2 , as discussed above, the operation known as sacrospinous vaginal vault suspension requires a surgeon to attached the rear or inner portion of the vaginal vault, typically on opposite sides of the vault, to the two sacrospinal ligaments  14 . As shown, an incision  10  is made through the lower rear wall of the vagina  12  in order to obtain access to the sacrospinal ligaments  14  located on opposite sides of the patient. The attachment points are indicated by the letter X on the ligaments. Once sutures have been located in the ligaments  14 , these may be used to connect artificial ties or ligaments, similarly as in the manner described in patent application PCT/AU00/01298. The artificial ties that are used are typically in a form of an inert mesh material adapted to remain permanently within the body of the subject. Further information relating to the manner in which such a procedure is performed may be obtained by reference to the two Obstetrics &amp; Gynaecology articles referred to in the background section of the specification. The information contained in those two documents are incorporated herein by way of reference. Once the operation has been completed the wall of the vagina will be repaired, with the vagina remaining secured to the sacrospinal ligaments  14  using the artificial ties as indicated in  FIG. 2  of the drawings. 
         [0031]    The present inventor has observed that for the reasons discussed above, inserting the sutures into the sacrospinal ligaments  14  of a patient can often be difficult, resulting in a delay to the completion of the operation or, unless care is taken, inferior attachment to the ligaments. Furthermore, as previously discussed, it is important that the sutures be placed transverse to the length of the ligaments  14 , rather than parallel to the length of the ligament  14  in order to achieve optimal and safe attachment. 
         [0032]    Referring to  FIGS. 3 ,  4  and  5 , an embodiment of a device according to the present invention and its manner of use is depicted. It will be appreciated that the device shown is depicted in somewhat schematic fashion but it is evident from the drawings how such a device may be used in practice. Furthermore, although shown diagrammatically, it will be understood that alternate shapes, geometries and sizes of the various features of the invention may be used in other embodiments without departing from the scope of the invention as claimed. 
         [0033]    As shown, the suturing device  20  comprises an elongate shaft member  30  having a C-shaped needle carrier  40  located a first end  32  thereof and a handle member  50  located at a second end  36 . Clearly the first end  32  is the end which is to be inserted into the patient&#39;s vagina, through the incision  10  of  FIG. 1 , in order to make the attachment X in the ligaments  14 . Thus, the length, shape and size of the shaft member  30  is selected to be able to optimally perform the operation. Where it is desired to use the suturing device  20  in other types of operations or procedures, clearly the configuration including the length of the shaft may vary from that shown herein in the present embodiment of the invention. In the present embodiment, when used in transvaginal application, it is envisaged that the overall length of the device will be about  25  cm although, clearly, different length devices could be utilised. 
         [0034]    The needle carrier  40  acts as a tooth or spike to pass through the ligament or other tissue through which it is desired to pass a suture. As shown, the tissue is indicated at numeral  60 , that being the sacrospinal ligaments referred to above. 
         [0035]    The needle carrier  40  is pivotally connected to the shaft member  30  through pivot pin  38  to extreme positions being distal the end  32  of the shaft  30 . Thus, the needle carrier  40  is able to pivot between a retracted position as shown in  FIG. 3 , and an engaged position shown in  FIG. 4 . 
         [0036]    The handle means  50  is used to move the needle carrier  40  between the two extreme positions. As shown, the handle means  50  has a fixed leg  52  and a pivotable leg  54  which can be moved forwards and backwards in the direction of arrow  33 . A connecting rod  70  is connected to the movable leg  54  via a pivotal connection  35  at the second end  36  of the shaft member  30 , and at the first end  32  of the shaft member is connected to the needle carrier  24  via pivot pin  37  which locates in a slot  42  formed in the proximal end  44  of the needle carrier  40 . Thus, when the rod  36  moves back and forward in relation to the longitudinal axis of the shaft member  30 , the pin  37  carries the needle carrier  40  with it, causing the needle carrier to pivot about a pivot pin  38 . The connecting rod  70  thus acts on the needle carrier  40  in the manner of a lever to operate the suturing device  20 . 
         [0037]    The needle carrier  40  carries a short stub needle  80  on the distal end  46  or forward end thereof, the stub needle  80  being a close or sliding fit in the distal end  46  of the needle carrier  40 , the distal end  46  being tubular. The stub needle  80  and the distal end  46  of the needle carrier  40  are engaged in a manner such that the stub needle  80  is prevented from inadvertently detaching from the needle carrier  40  in use. However, when gripped, the stub needle  80  detaches from the needle carrier  40 , in the manner as described below. 
         [0038]    The stub needle  40  is coaxially joined to a suture  90  in the manner as shown in  FIGS. 3 to 5 , the suture  90  extending rearwardly from the stub needle  80  and out of the tubular distal end portion  46  of the needle carrier  40  through a slot  48  in the needle carrier  40 . It is considered advantageous that the suture  90  is coaxially joined to the stub needle  80  such that if, inadvertently, the stub needle  80  becomes detached from the needle carrier  40  prior to the operation being completed, the needle  46  may be withdrawn from the patient by simply pulling on the free end  92  of the suture  90 , that is, from outside of the patient. 
         [0039]    In order to pass the suture  90  through the ligament  60  the first end  32  of the shaft member  30  of the suturing device  20  is passed into the patient, in the manner as described above, until the stub needle  80  is located at the far side of the ligament  60 . This is the position as depicted in  FIG. 3  of the drawings. Thereafter the device may be pulled slightly in order to ensure the stub needle  80  is at least slightly embedded in the ligament  60 . It will be appreciated that during this operation, the surgeon is able to visually inspect the location of the stub needle  80  as since the shaft member  30  is preferably relatively slender and will not obscure the surgeon&#39;s view. Also, the surgeon does not need to place the fingers of his or her other hand within the patient in order to ensure the location of the stub needle  80  is correct. As mentioned above, the ability to place the suture  90  using only one hand and having an unimpeded view is considered to be important from a practical standpoint. 
         [0040]    When the appropriate location of the stub needle  80  has been determined and the stub needle  80  appropriately located, the pivotable leg  54  of handle means  50  may be moved towards the fixed leg  52  of the handle means  50 , thereby pushing the connecting rod  70  distally which in turn causes the needle carrier  40  to pivot about pin  38  and travel through the ligament  60  into a position as shown in  FIG. 4  of the drawings. 
         [0041]    The suturing device  20  further includes a needle capture means  100 , in this embodiment being formed integrally with and located at the underside of the shaft member  30 . The needle capture means  100  includes a receiving aperture  102  extending into the shaft member  30  into which the stub needle  80  is driven as the needle carrier  40  rotates about pivot pin  38 . The needle capture means  100  includes a catch mechanism  104  which is arranged so as to engage with the stub needle  80 . 
         [0042]    The needle capture means  100  may operate automatically by a spring mechanism biased to as to cause the stub needle  80  to be captured and is discussed in more detail with respect to  FIGS. 6 to 8  below. In the present embodiment, the needle capture means  100  includes a lever  106  operably connected to the catch mechanism  104  by a tie rod  108  which allows the catch mechanism  104  to retracted so as to release the stub needle  80 . 
         [0043]    Although in the present embodiment the needle capture means  100  is automatically operated by a spring mechanism, it is envisaged that some surgeons may prefer to manually cause engagement in which case a connection mechanism other than a spring loaded latch mechanism will be used to engage and capture the stub needle  80 . Once the stub needle  80  has been engaged, as depicted in  FIG. 4 , the pivotable leg  54  of the handle is moved in a direction away from the fixed leg  52  causing the needle carrier  40  to be retracted from its fully advanced position towards the position shown in  FIG. 5 . However, as the stub needle  80  is now captively held in the aperture  102 , this movement causes the stub needle  80  to be disengaged from the end  46  of the needle carrier  40  as shown whilst maintaining the stub needle  80  engaged with the needle capture means  100  as the needle carrier  40  is retracted to an advanced position. As the needle carrier  40  is advanced away from the stub needle  80 , the suture  90  slides through the slot  48 . 
         [0044]    By fully retracting the needle carrier  40  to a fully retracted position, the needle carrier  40  will be caused to reverse out of the ligament  60  leaving the suture  90  in position. As the suture  90  is located in the slot  48  in the needle carrier  40 , as the stub needle  80  is withdrawn from the needle carrier  40 , the suture  90  will disengage from the needle carrier  40  out of the slot  48 . 
         [0045]    The suturing device  20  device may now be retracted from the patient and by slowly pulling the device  20  whilst the stub needle  80  is retained by the needle capture means  100  in the aperture  102  the suture  90  is pulled through the ligament  60  until the two ends of the suture are located outside of the patient. Once this has been achieved the suture  90  may be severed from the stub needle  80  and the surgeon can proceed with attaching the artificial ligament to the sacrospinal ligament in the manner disclosed in patent application PCT/AU00/01298. Further description of how the operation is completed need not be discussed herein, but it will be understood that by transferring the stub needle  80  from the needle carrier  40  to the aperture  102  and then retracting the needle carrier  80 , a one handed insertion of the suture  90  into the ligament  60  can be achieved. 
         [0046]    Furthermore, because of the curved configuration of the needle carrier  40  the needle can be driven in a circular arc, and also the hook shaped nature of the needle carrier  40  ensures that a suitable bite of the ligament  60  can be achieved without the surgeon having to manipulate the ligament with his or her fingers. Furthermore, the geometry of the various members of the device  20  and the offset between pivot point of the mechanism may be arranged so as to provide appropriate mechanical advantage for driving the needle carrier  40  through the ligament  60 . It is envisaged that the needle carrier  40  will have a radius of curvature of between about 5 mm and 30 mm although a radius of curvature of about 10 mm is considered to be the preferred configuration for this type of operation. 
         [0047]    Three different engagement arrangements between the stub needle  80  and the needle capture means  100  are depicted in  FIGS. 6 to 8 . It must be understood, however, that other arrangements are possible but what is required is a relatively simple arrangement that reliably captures the needle and does not require excess force for engagement. 
         [0048]    In  FIG. 6 , another embodiment of a needle capture means  110  is depicted having a spring loaded latch  112  which is slidable in a slot  114  which lies parallel to the length of the shaft  30  of the device as described above. A compression spring  116  is located around a connecting rod  118  of the latch  112  and the latch  112  will move in the direction of arrow  111  when the stub needle  80  is moved into the aperture  113  in the direction of arrow  115 . It will be noted that the latch  112  has a bevelled surface  117  against which the stub needle  80  will press in order to urge the latch back against the action of the spring  116 . Once the stub needle  80  has been fully advanced into the aperture  113 , the latch  112  will engage in an annular groove  82  located behind the sharp end or head of the stub needle  86 . The compression spring  116  will then hold the latch  112  in the groove  82  so that when the needle carrier  40  is retracted, the stub needle  80  remains captured in the aperture  113 . It will be noted that the stub needle  80  has a shoulder  88  which will located against the forward end of the needle carrier  80 . Also the needle carrier  80  is provided with the slot  45  to allow the suture  90  to connect axially into the rear end of the stub needle  80 . 
         [0049]    The needle capture means  120  as depicted in  FIG. 7  of the drawing is similar to that as depicted in  FIG. 6  except that the latch device  122  is provided with a forward facing lever  124 . This lever  124  can only be used to disengage the stub needle  80  from the aperture  113  when the device  20  is removed from the patient, but since this is typically the only time when the stub needle  80  would be required to be disengaged from the aperture  113 , this arrangement may be preferable in some instances. 
         [0050]    The needle capture means  130  as shown in  FIG. 8  provides a narrow plate  132  with a aperture  134  therein through which the stub needle  80  passes as the stub needle passes into the opening  113  as shown in  FIGS. 6 and 7 . The plate  132  is connected to rod  136  which can either be manually manipulable from the rear end of the suturing device  20 , or may be spring loaded to allow for automatic latching of the needle as it is advanced into its fully advanced position, similarly as described with reference to the above embodiments of needle capture means. 
         [0051]    Clearly there may be many variations to the above described embodiments without departing from the scope of the invention. Some of the features which are considered to be important are the curved nature of the needle carrier which allows the device to take a “bite” of tissue, such as the ligament described herein, even at relatively remote locations within the body, and even where the tissue to be engaged lies relatively flat. The maimer in which the needle detaches from the needle carrier and the fact that the needle could, if necessary, be retracted from the tissue by pulling on the free end of the suture is also considered advantageous over at least some prior art devices. As mentioned previously, where the device is to be used for suturing different types of operations the overall configuration of the device might need to be quite different from that described herein. 
         [0052]    It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.