Abstract:
A method of arresting blood vessels in soft tissue at a predetermined location relative to an excision location where a part of the soft tissue is to be removed, is described. The method comprises securing at least one clip to a retention means of at least one of a pair of fingers of forceps. The fingers of the forceps are then positioned on a respective side of the tissue at the predetermined location. The fingers are displaced towards one another to cause the at least one clip to penetrate the soft tissue and form a clamp whereby to clamp the blood vessels at the predetermined location. Thereafter an excision is made to remove the portion of the soft tissue and the fingers of the forceps are withdrawn with the clamp retained engaged by the clip. The clip, device and method achieve a substantially bloodless and painless surgical procedure. The clip is constructed from bioabsorbable polymeric material and may be impregnated with an analgesic, anesthetic, an antibiotic or an anti-inflammatory substance.

Description:
TECHNICAL FIELD 
       [0001]    The present invention generally relates to cicatrisation of bodily soft tissue and, more particularly, to clips for joining parts of soft tissue, a device for applying the clips to clamp the parts of tissue, and a method for using the device to achieve substantially bloodless and painless surgical procedure. 
       BACKGROUND ART 
       [0002]    Traditionally, in the surgical field, wounds to bodily soft tissue are closed by stitching. Although stitching has proven to be effective, in several situations, the technique can be cumbersome and lengthy. Other methods and techniques are contemplated to reduce surgery time in given types of surgery and to avoid other complications. 
         [0003]    As shown at www.jnjgateway.com, skin stapling devices have been provided as an alternative to stitching. The skin stapling devices apply staples to interconnect parts of soft tissue for cicatrisation. For instance, the Proximate Plus MD skin stapler, as shown from the above-cited website, is a single patient use instrument sold ready for use. The skin stapler uses stainless steel staples, and is therefore for external applications, as the staples must be removed after sufficient cicatrisation of the tissues has occurred. 
       SUMMARY OF INVENTION 
       [0004]    It is a feature of the present invention to provide novel clips for joining parts of bodily soft tissue for cicatrisation and providing for a substantially bloodless and painless surgical procedure. 
         [0005]    It is a further feature of the present invention to provide a device for applying the clips of the present invention. 
         [0006]    It is a still further feature of the present invention to provide a method for using the device for applying clips of the present invention. 
         [0007]    According to the above features, from a broad aspect, the present invention provides a method of arresting blood vessels in soft tissue at a predetermined location relative to an excision location where a part of the soft tissue is to be removed. The method comprises the steps of securing at least one clip to a retention means of at least one of a pair of fingers of forceps. The fingers are positioned on a respective side of the tissue at the predetermined location. The fingers are then displaced towards one another to cause the at least one clip to penetrate the soft tissue and form a clamp whereby to clamp the blood vessels at the predetermined location. 
         [0008]    According to a further broad aspect of the present invention there is provided a clip device for joining portions of bodily soft tissue, the clip device comprising at least two treading portions adapted to be inserted through portions of bodily soft tissue to be joined; a coupling portion connected to the at least two treading portions to secure the threading portions to the portions of bodily soft tissue; and at least one of an anesthetic, analgesic and an antibiotic drug in at least one of the treading portions and the coupling portion and releasable for at least one of pain relief and prevention of infection of the soft tissue. 
         [0009]    According to a still further broad aspect of the present invention, there is provided a device for applying a clip to join portions of bodily soft tissue, comprising a forceps having a pair of members each pivotally mounted to one another and each defining a handle portion and a finger potion, the handle portion being operable to displace the finger portions in a scissor action; and retention means on at least one of the finger portions, the retention means adapted to receive a clip for joining portions of bodily soft tissue; wherein a closing action of the forceps will cause the clip to be secured to the portions of bodily soft tissue. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0010]    A preferred embodiment of the present invention will now be described with reference to the accompanying drawings in which: 
           [0011]      FIG. 1  is a perspective view of the device for applying a clip in accordance with a basic configuration of the present invention; 
           [0012]      FIG. 2A  is a perspective view of a first arm of the device; 
           [0013]      FIG. 2B  is a perspective view of a second arm of the device; 
           [0014]      FIG. 3  is a perspective view of the device for applying a clip having sinuous clip engaging surfaces; 
           [0015]      FIG. 4  is an enlarged perspective view of one of the sinuous clip engaging surfaces of the device of  FIG. 3 ; 
           [0016]      FIG. 5  is an enlarged perspective view of fingers of the device for applying clips having channeled clip engaging surfaces; 
           [0017]      FIG. 6  is a schematic front elevation view of an outline of part of a sinuous clip portion constructed in accordance with the present invention, for use with the device of  FIG. 3 ; 
           [0018]      FIG. 7  is a front elevation view of a staple clip constructed in accordance with the present invention, to be used with the device of  FIG. 5 ; 
           [0019]      FIG. 8  is a front elevation view of a bank of staple clips constructed in accordance with the present invention, to be used with the device of  FIG. 5 ; 
           [0020]      FIG. 9  is a front elevation view of the staple clip of  FIG. 7  having been bent by the device of  FIG. 5 ; 
           [0021]      FIG. 10  is a perspective view of another clip constructed in accordance with the present invention, to be used with the device of  FIG. 5 ; 
           [0022]      FIG. 11  is a front elevation view of the clip of  FIG. 10 ; 
           [0023]      FIG. 12  is a enlarged view of fingers of an embodiment of the device of  FIG. 5 ; 
           [0024]      FIG. 13  is a perspective view, from a downward point of view, of the device for applying a clip in accordance with a further embodiment of the present invention; 
           [0025]      FIG. 14  is a perspective view, from a lateral point of view, of the device for applying a clip of  FIG. 13 ; 
           [0026]      FIG. 15  is an enlarged perspective view, from the downward point of view, of an operative portion of the device for applying a clip of  FIG. 13 , with a clip therein; 
           [0027]      FIG. 16  is an enlarged perspective view, partly sectioned, from the downward point of view, of fingers of the operative portion of the device for applying a clip of  FIG. 13 , with a clip therein; 
           [0028]      FIG. 17  is a perspective view of a clip constructed in accordance with a further embodiment of the present invention; 
           [0029]      FIG. 18  is an exploded view of the clip of  FIG. 17 , with layers of soft tissue therebetween; 
           [0030]      FIG. 19  is an enlarged perspective view of the clip of  FIG. 17 ; and 
           [0031]      FIG. 20  is an enlarged perspective view, from the lateral point of view, of the operative portion of the device for applying a clip of  FIG. 13 , with the clip of  FIG. 17  therein. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0032]    An alternative to stitching consists in providing a bio-absorbable clip that will resolve with time, along with a device for applying the clip. The clip and device combination can be used in given types of surgical procedures. For instance, the use of the clip and device combination is contemplated for the “Closed Bloodless Hemorrhoidectomy Method” as described in co-pending U.S. application Ser. No. 10/152,563, filed on May 23, 2002, by the present inventor. 
         [0033]    Referring to the drawings and, more particularly to  FIGS. 1 ,  2 A and  2 B, a device for applying a clip constructed in accordance with a basic configuration of the present invention is generally shown at  10 . The device  10  is made of a material (e.g., such as stainless steel, titanium) adapted for high-pressure autoclave, as it will be reusable and will thus require to be sterilizable. The device  10  has a forceps defined by a first arm  12 A and a second arm  12 B. For clarity purposes, components of the device  10  affixed with an “A” will be part of the first arm  12 A, whereas components of the device  10  affixed with a “B” will be part of the second arm  12 B. 
         [0034]    The device  10  has a handle portion  14  and an operative portion  16 . The first arm  12 A and the second arm  12 B are pivotally connected to one another at pivot  18  by a pivot pin, in a scissor-like fashion. The handle portion  14  and the operative portion  16  are separated by the pivot  18 . 
         [0035]    The handle portion  14  has finger engaging loops  20 A and  20 B in which fingers of a user person are inserted to handle/manipulate the operative end  16  of the device  10 . Abutment stoppers  22 A and  22 B limit the motion of the device  10  in a closing direction thereof. 
         [0036]    At the pivot  18 , the first arm  12 A has a slot  24 A. The slot  24 A is defined by a pair of parallel walls. A throughbore  26 A is normal to the parallel walls and is provided for receiving the pivot  18 . The second arm  12 B has a connector wall portion  28 B having a pair of parallel surfaces for sliding contact with the inner surface of the slot  24 A when the arms  12 A and  12 B are coupled to one another. A throughbore  30 B is normal to the parallel surfaces, and is coaxially positioned with respect to the throughbore  26 A when the arms  12 A and  12 B are coupled to one another, so as to receive the pivot  18  therein. 
         [0037]    The operative end  16  of the device  10  comprises fingers  40 A and  40 B. The fingers  40 A and  40 B have respective clip supporting surfaces  42 A and  42 B. The fingers  40 A and  40 B are curved with respect to a plane in which the device  10  generally lies. This feature is preferable as it increases the visibility of the fingers  40 A and  40 B by the surgeon. As also illustrated in  FIGS. 1 ,  2 A and  2 B, the clip engaging surfaces  42 A and  42 B are substantially flat. However, as will be described hereinafter, the clip engaging surfaces  42 A and  42 B may have various patterns or shapes. The abutment stoppers  22 A and  22 B are positioned to come into contact one against the other generally simultaneously with the coplanar encounter of the clip engaging surfaces  42 A and  42 B. 
         [0038]    Although not shown in  FIGS. 1 ,  2 A and  2 B, the device  10  is provided with clip retention means on the clip engaging surfaces  42 A and  42 B, for securing clips to be applied during surgery. This will also be described in detail hereinafter during a description of given embodiments. 
         [0039]    Referring to  FIGS. 3 and 4 , the device  10  is shown having a given pattern on the clip engaging surfaces  42 A and  42 B. More precisely, the patterns can be described as sinuous from a viewpoint normal to a plane in which both fingers  40  lie. The patterns are out of phase with respect to one another so as to intermesh when the device  10  is in its closed position. 
         [0040]    As seen in  FIG. 4 , a pair of connector holes  44 A are provided at opposed ends of the pattern of the clip engaging surface  42 A. The holes  44 A are axially normal to the clip engaging surface  42 A. Accordingly, a clip portion  60  having a pair of sinuous surfaces, as shown in  FIG. 6 , and provided with a pair of connector pins  62  at opposed ends thereof, can be releasably positioned against the clip engaging surface  42 A with the connector pins  62  received in the connector holes  44 A. A complementary clip portion (not shown) is retained on the clip engaging surface  42 B in a similar fashion to the clip portion  60  (i.e., connector pins). Once the clip portion  60  and complementary clip portion are positioned on the device  10 , the fingers  40 A and  40 B are closed against one another, whereby connection means (i.e., treading portion  64 ) on the clip portion  60  and complementary clip can cooperate to form a clip as a response to a closing action and pressure of the device  10 , to secure soft tissue therebetween for cicatrisation. Once the clip portion  60  and the complementary clip are interconnected to squeeze soft tissue and surgical procedures are done (e.g., excision), the device  10  is opened, and the fingers  40 A and  40 B are thus separated from one another, thereby releasing the clip therefrom. The device  10  can thus receive another clip for further application. 
         [0041]    Referring to  FIG. 5 , the device  10  has a channel  50 A along its clip engaging surface  42 A of the finger  40 A. The channel  50 A is adapted to receive and retain various types of clips. 
         [0042]    As shown in  FIG. 7 , a staple clip, in accordance with the present invention, is generally shown at  70 . The staple clip  70  has opposed treading portions  72  to puncture the soft tissue and a coupling portion  74  interconnecting the treading portions  72 . The staple clip  70  is held in the channel  50 A, by the coupling portion  74  being inserted in friction fit therein. In  FIG. 5 , a plurality of staples  70 , in the form of a bank of staples as will be described hereinafter, is shown being inserted into the channel  50 A. It is preferred that the channel  50 A fully accommodates the staples  70  such that the surgeon is free to displace the device  10  on the soft tissue without the staples  70  interfering 
         [0043]    As seen in  FIG. 12 , the finger  40 B has a protruding bar  43 B with deflecting formations. Accordingly, when a closing action is performed on the device  10 , the protruding bar  43 B enters the cavity  50 A with soft tissue being entrained therein. In doing so, the treading portions  72  of the staple clip  70  puncture the parts of soft tissue, to meet with the deflecting formations of the protruding bar  43 B to cause the treading portions  72  to bend inwardly (similarly to a paper staple), as illustrated in  FIG. 9  to provide securement and retention. Accordingly, soft tissue is squeezed between the bent treading portions  72  and the coupling portion  74 , so as to facilitate cicatrisation. 
         [0044]    As shown in  FIG. 8 , a bank of staple clips  70  is generally shown at  80 , and consists of a plurality of side by side staple clips  70 . The bank  80  can be used for joining soft tissue of a relatively straight wound. 
         [0045]    Referring to  FIGS. 10 and 11 , a clip adapted to be used with the device  10  of  FIG. 5  is generally shown at  100 . The clip  100  has a male portion  102 A and a female portion  102 B. The male portion  102 A has a body having a contact surface  104 A and an applying surface  106 A. A plurality of treading portions  108 A are normal to the contact surface  104 A, whereas a plurality of connectors  110 A are normal to the applying surface  106 A. The treading portion  108 A each consist of a stem having a pointed head at a free end thereof. The pointed head is required to puncture soft tissue. 
         [0046]    The female portion  102 B has a body having a contact surface  104 B and an applying surface  106 B. The female portion  102 B is similar to the male portion  102 A as it has a plurality of connectors  110 B normal to the applying surface. The female portion  102 B differs from the male portion  104 B in that it is provided with throughbores  112 B. 
         [0047]    As shown in  FIG. 10 , the spacing between the throughbores  112 B is equivalent to the spacing between the treading portions  108 A, such that the male portion  102 A and the female portion  102 B can be interconnected by cooperation of the treading portions  108 A and the throughbores  112 B. The pointed heads of the treading portions  108 A is preferably larger in diameter than the throughbores  112 B to ensure that the connectors  102 A and  102 B remain connected to one another, with parts of soft tissue squeezed between the contact surfaces  104 A and  104 B for cicatrisation. The clip  100  preferably consists of a biodegradable polymer, whereby it has some level of resiliency, such that the pointed heads can squeeze through the throughbores  112 B even though they are of larger diameter. 
         [0048]    The clips  100  are applied to soft tissue by way of the connectors  110 A and  110 B being received in the channel  50 A in  FIG. 5  and a corresponding channel (not shown) of the finger  40 B. The channels  50  prevent lateral displacement of the clips  100  with respect to the clip engaging surfaces  42  and provide perfect alignment of the male and female portions of the clip. A closing action of the device  10  causes the male portion  102 A and the female portion  102 B to interconnect with soft tissue squeezed between the contact surfaces  104 A and  101 B. Once the portion  102 A and  102 B are interconnected, the device  10  can be opened to release the portions  102 A and  102 B. 
         [0049]    It is also contemplated to provide the device  10  with snap-fit locking means to releasably secure the clip portion thereto. The snap-fit locking means would be adapted to release the clip upon separation of the fingers  40 A and  40 B from one another. The interconnection force between the portions of the clip would be above the force required the snap-fit force retaining the clip portions to the device  10 . 
         [0050]    As described in U.S. application Ser. No. 10/152,563, some types of surgical procedures involve joining parts of soft tissue prior to proceeding with an excision. Accordingly, a use of the clips and device of the present invention is contemplated for closed bloodless excision surgery. In such a case, the device  10  can be kept in place to apply pressure on the clips to ensure proper hemostasis. 
         [0051]    The clips described in  FIGS. 6 to 11  are preferably made of a bio-absorbable polymeric material and are coated or may encapsulate a pharmaceutical agent, such as an anesthetic, an analgesic and/or an antibiotic for gradual local delivery to the soft tissue being held for cicatrisation. An anti-inflammatory agent may also be encapsulated. For instance, an antibiotic such as Cipro™ can be used for the treatment of acute hemorrhoidal disease. A suitable anesthetic is Xylocaine™, and suitable analgesics are Celebrex™ and Toradol™. In the case of encapsulated agents, the biodegradation of the clips will cause the release of the agent, thereby delivering the agent locally. This will enable to avoid in most cases having to prescribe narcotics to the patient following surgery. The use of the clips in accordance with the present invention will substantially reduce the pain caused by the surgery in the case where an analgesic is used. 
         [0052]    Referring to the drawings and, more particularly to  FIGS. 13 and 14 , a device for applying a clip constructed in accordance with another embodiment of the present invention is generally shown at  210 . The device  210  is made of a material (e.g., such as stainless steel, titanium) adapted for high-pressure autoclave, as it will be reusable and will thus require to be sterilizable. The device  210  has a forceps defined by a first arm  212 A, a second arm  212 B, and a third arm  212 C. For clarity purposes, components of the device  210  affixed with an “A” will be part of the first arm  212 A, components of the device  210  affixed with a “B” will be part of the second arm  212 B, and components of the device  210  affixed with a “C” will be part of the third arm  212 C. 
         [0053]    The device  210  has a handle portion  214  and an operative portion  216 . The first arm  212 A, the second arm  212 B and the third arm  212 C are pivotally connected to one another at pivot  218  by a pivot pin, in a scissor-like fashion. The first arm  212 A and the second arm  212 B will be used to position bodily soft tissue to be cicatrized between clip portions, as will be described hereinafter. The third arm  212 C will be used to lock the clip portions to one another, with the bodily soft tissue to be cicatrized therebetween. 
         [0054]    The handle portion  214  and the operative portion  216  are separated by the pivot  218 . The first arm  212 A holds the pivot  218  between a pair of spaced plates  224  thereof. The second arm  212 B and the third arm  212 C have plate portions  226 B and  226 C, respectively, by which they are in pivoting connection with the pivot  218 . 
       First Arm  212 A and Second Arm  212 B 
       [0055]    The handle portion  214  has finger engaging loops  220 A and  220 B in which fingers of a user person are inserted to manipulate the operative portion  216  of the device  210 . Abutment channel  222 A and abutment  222 B limit the motion of the device  210  in a closing direction thereof. 
         [0056]    The operative portion  216  of the device  210  comprises fingers  240 A,  240 B and  240 C. The fingers  240 A and  240 B have respective clip supporting portions  242 A and  242 B. More specifically, as shown in  FIGS. 15 and 16 , the clip supporting portion  242 A is a receptacle in which a clip portion A is retained. As seen in  FIG. 16 , a slot  243 A communicates with the clip supporting portion  242 A, and will be used to remove the clip portion A from the clip supporting portion  242 A, as will be described hereinafter. 
         [0057]    The clip supporting portion  242 B receives a clip portion B that is complementary to clip portion A, as will be described hereinafter. More specifically, the clip supporting portion  242 B has a plurality of throughbores  243 B. 
       Third Arm  212 C 
       [0058]    Referring to  FIG. 13 , and as mentioned previously, the third arm  212 C is used to lock the clip portions A and B together. 
         [0059]    The third arm  212 C has a ratchet portion  220 C adjacent to the finger-engaging loops  220 A and  220 B. The ratchet portion  220 C will cooperate with a retaining member  223 A of the first arm  212 A, such that the third arm  212 C cannot be separated by scissor motion once the ratchet portion  220 C and the retaining member  223 A are engaged. A lateral pressure, normal to the plane of the device  210  is applied to separate the ratchet portion  220 C from the retaining member  223 A. 
         [0060]    The third arm  212 C has the finger  240 C, which has a compressing member  243 C. The compressing member  243 C is sized so as to be received through the slot  243 A, with a closing scissor motion between the first arm  212 A and the third arm  212 C. 
       Clip  250   
       [0061]    Referring to  FIGS. 17 and 18 , a clip in accordance with an embodiment of the present invention is generally shown at  250 . The clip  250  has the clip portion A, and the clip portion B. 
         [0062]    The clip portion A has a brace portion  251 A, from which project male connectors  252 A. The male connectors  252 A each have a pointy end and a series of annular wedges  253 A. 
         [0063]    The clip portion B has a brace portion  251 B, with a plurality of female connectors  252 B. The female connectors  252 B each have fins  253 B that will cooperate with the annular wedges  253 A to enable the reception and locking of the male connectors  252 A in the female connectors  252 B, as shown in  FIG. 17 , and enlarged in  FIG. 19 . 
         [0064]    In  FIG. 18 , soft tissue layers to be cicatrized are shown schematically at S 1  and S 2 . The clip  250  is similar to the clips described in  FIGS. 6 to 11  in composition. Therefore, the clip  250  is preferably biodegradable so as to degrade over the cicatrization of the soft tissue layers S 1  and  52 . 
         [0000]    Application of the Clip  250  with the Device  210   
         [0065]    Referring concurrently to  FIGS. 13 ,  16  and  18 , clip portions A and B of the clip  250  are positioned in the clip supporting portions  242 A and  242 B, respectively. The fingers  240 A and  240 B are spaced from each other by the handle of the device  210 , using the finger-engaging loops  220 A and  220 B. Layers of soft tissue to be cicatrized are positioned between the clips A and B, as illustrated in  FIG. 18 . 
         [0066]    At this point, the fingers  240 A and  240 B can be brought together, once more by the leverage provided by the finger-engaging loops  220 A and  220 B. The layers of soft tissue are retained between the clip portions A and B. As mentioned previously, the motion of the fingers  240 A and  240 B is restricted by the abutment channel  222 A and the abutment  222 B ( FIG. 13 ). 
         [0067]    At this point, the clip portions A and B are locked to one another so as to retain the layers of soft tissue therebetween. This step is performed using the third arm  212 C. The closing motion of the third arm  212 C will result in the compressing member  243 C entering the slot  243 A, and pressing against the clip portion A. This pressure will result in the clip portions A and B interconnecting, with the soft tissue layers squeezed therebetween. The cooperation between the ratchet portion  220 C and the retaining member  223 A will keep the fingers  240 A and  240 C together. 
         [0068]    Therefore, following the applied pressure of the third arm  212 C, the clip  250  will be formed with the layers of soft tissue therebetween. The cooperation between the clip portions A and B will ensure that the clip  250  remains in position. The clip  250  will degrade over time, releasing an anesthetic or the like if required, and leaving the soft tissue cicatrized. It is pointed out that the clip and its application by the forceps of the invention results in the excision of tissue and which procedure is substantially bloodless and painless to the patient. 
         [0069]    It is within the ambit of the present invention to cover any obvious modifications of the embodiments described herein, provided such modifications fall within the scope of the appended claims.