Abstract:
A pyeloplasty clip for surgical use is operable in a first condition to clamp together portions of human tissue that are to be severed. The clip is then operable in a second condition either to separate and maintain in an open condition the severed tissue portions, or to displace the clamped severed tissue portions toward each other. A fastener arrangement serves to maintain together the clamping leg portions of the clip until the human body has healed. A separating device may be provided for subsequently unfastening and opening the clamping leg portions, thereby to permit removal of the clip from the human body.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     A pyeloplasty clip for surgical use is operable in a first condition to clamp together portions of human tissue that are to be severed or joined. The clip is then operable in a second condition either to separate and maintain in an open condition the severed tissue portions, or to displace the clamped tissue portions toward each other. Fastener means serve to maintain together the clamping leg portions until the human body has healed, and separating means are provided for subsequently unfastening and opening the clamping leg portions.  
         [0003]     2. Description of the Related Art  
         [0004]     The provision of various types of surgical clips is well known in the patented and published prior art for performing gastroesphageal fund oplication, as evidenced by the published patent applications of Sixto, et al., Nos. 2002/0068945 and 2002/0138086, and Kortenbach, et al., No. 2002/0068946.  
         [0005]     In Monassevitch, et al., published application No. 2002/0177859, a surgical grip applicator device includes means for gripping and positioning a surgical clip relative to hollow organ portions, and releasing means for releasing the clip. Tissue cutting apparatus is provided for cutting through the tissue walls.  
         [0006]     The Yoon U.S. Pat. No. 5,217,473 relates to multi-function surgical instruments including stretch ligating and occluding devices. The surgical devices include leg portions that may be provided with serrated legs, and with mating pin and aperture engaging means which enhance the locking of the clip onto the tissue being occluded.  
         [0007]     The present invention was developed to provide an improved pyeloplasty clip that is operable in a first condition to clamp together portions of human tissue that are to be joined and severed, and in a second condition to maintain the tissue portions in a desired open or closed relation during healing.  
       BRIEF SUMMARY OF THE INVENTION  
       [0008]     Accordingly, a primary object of the present invention is to provide an improved pyeloplasty clip including a unitary clip body having four adjacent spaced linear leg portions, a first insertion portion connecting adjacent ends of first and second ones of the leg portions, a second insertion portion connecting corresponding adjacent ends of third and fourth leg portions, a first joinder portion connecting the other ends of the first and third leg portions, and a second joinder portion connecting the other ends of the second and fourth leg portions. The clip body normally has a first expanded condition in which the first and second insertion portions and the associated leg portions are spaced to define a chamber for receiving the human tissue that is to be treated. The clip body is operable to a clamped second condition by bending of the joinder portions to displace the insertion portions together into clamping engagement with the human tissue contained therebetween.  
         [0009]     According to another object of the invention, the clamped tissue may be severed along a line of severing extending from a point between the joinder portions of the clip toward the insertion portions, whereupon the clip is operable toward a separated third condition in which, as a result of the bending of the first and second insertion portions, the first joinder and associated leg portions are displaced apart from the second joinder and associated leg portions, thereby to maintain the clamped severed human tissue portions in a separated condition. Alternatively, in the case of severing for the removal of human tissue, the first and second joinder portions and associated leg portions could be displaced together toward a closed position for healing of the human body.  
         [0010]     Another object of the invention is to provide fastening means operable to fasten together the first and third leg portions and the second and fourth leg portions when the clip is in the clamping second condition. Fastening pins extend from one leg through the clamped tissue into corresponding fastening locking openings contained in the associated leg on the other side of the tissue. Separating means may be provided for separating the fastened leg portions after the human body has healed.  
         [0011]     The pyeloplasty clip of the present invention is a very small and simple device for increasing the size of and initial bifurcation between any tow organs, tubes, arteries or veins. One application of the clip is for congenital uretero-pelvic-junction (UPJ) with hydronephrosis. In such cases, the UPJ is usually occluded and the pyeloplasty clip with its associated surgical procedure, is used to enlarge the occlusion and to maintain the opening with an adequate area for the flow of fluids. In this case, the clip is removed after the healing period of about 2 to 3 weeks. In the case of “foreign body” insertions in urinary tracts, the removal of the clip is critical because of possible long-term deposits on the foreign body and stone formation. This simple procedure with the pyeloplasty clip greatly reduces the recuperation time of the individual as compared to the prevalent procedures of endo-pyelotomy. An open procedure normally takes about two hours of operating time in the surgery operating room, but with the use of the clip of the present invention, the procedure requires minimal surgery and can be done on an outpatient basis or with a maximum of one day of hospitalization. The procedure produces minimum suffering, and the reduction of occlusion to fluid flow is comparable to open surgery.  
         [0012]     Another application of the pyeloplasty clip of the present invention is the reduction of constricted arterial bifurcations. In these cases, the clip is permanently left inside the artery to maintain the enlarged area at the bifurcation.  
         [0013]     The pyeloplasty clip is applicable to all bifurcations that require the lumen to be opened up and expanded, wherever there is a need for enlargement of a bifurcation. The thin clip is inserted from the larger lumen of the connecting organ or tube at the location of the bifurcation. The area of the initial bifurcation is increased either by an added manual incision between the legs of the clip, or in anther design, the incision is automatically achieved when the legs of the clip are joined. In some cases, the clip is left inside the organ, while in other situations, the clip is removed by means of a flexible string arrangement. The clip may be formed from stainless steel, shape memory retaining alloys, or from a synthetic plastic material having similar resilient properties. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]     Other objects and advantages of the invention will become apparent from a study of the following specification when viewed in the light of the accompanying drawings, in which:  
         [0015]      FIGS. 1 and 2  are front perspective and left side elevation views, respectively, of the pyeloplasty clip of the present invention;  
         [0016]      FIG. 3  is a sectional view illustrating the use of the clip of  FIG. 1  when in a clamped condition relative to tissue of a human body;  
         [0017]      FIG. 4  is a detailed sectional view illustrating the tissue severing operation on tissue clamped by the clip of  FIG. 1 , and  FIG. 5  is a corresponding view illustrating the spreading of the clamped tissue when the clip is in its second separated condition;  
         [0018]      FIG. 6  is a perspective left hand side view of a second embodiment of the pyeloplasty clip of  FIG. 1 , and  FIG. 7  is a detailed sectional view of the fastening means of the pyeloplasty clip of  FIG. 6 ;  
         [0019]      FIGS. 8 and 9  are sectional views illustrating the insertion and clamping operations, respectively, of the pyeloplasty clip of  FIG. 6 ;  
         [0020]      FIGS. 10 and 11  illustrate the use of separation means for separating the leg portions of a clamped pyeloplasty clip;  
         [0021]      FIG. 12  is a perspective view of a preferred form of the invention, and  FIG. 13  is a modification of the clip of  FIG. 12 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]     Referring first more particularly to  FIGS. 1 and 2 , the pyeloplasty clip  1  of the present invention includes four spaced generally parallel linear leg portions  2 ,  4 ,  6 ,  8 . The lower ends of first and second leg portions  2  and  4  are connected by a first insertion portion  10 , and the lower ends of the third and fourth leg portions  6  and  8  are connected by a second insertion portion  12 . At their upper ends, the first and third leg portions  2  and  6  are connected by a first joinder portion  14 , and the second and fourth leg portions  4  and  8  are connected by a second joinder portion  16 . The unitary clip body is formed from a suitable metal material, such as stainless steel, shape-memory alloys, or a suitable synthetic plastic material. The linear leg portions of the clip are rigid, and the curved concave insertion and joinder portions are deformable or bendable, as will be described in greater detail below. The first and second legs  2  and  4  and the associated insertion portion  10  are contained in a common first plane P 1  ( FIG. 2 ), and the third and fourth leg portions  6  and  8  and the associated insertion portion  12  are contained in a common second plane P 2 . Preferably the planes are arranged at an acute angle α relative to the associated joinder portions  14  and  12 , thereby to define a space S for receiving tissue of the human body that is to be clamped together.  
         [0023]     Referring now to  FIGS. 3-5 , when the insertion portions  10  and  12  of the pyeloplasty clip are introduced into the organ  17  and tube  19  on opposite sides of the fold of human tissue  21  that is to be clamped together, the clip is bent relative to the joinder portions  14  and  16  to cause the insertion portions  10  and  12  and the associated leg portions contained in planes P 1  and P 2 , respectively, to be displaced together, and thus into a tight clamping engagement with the human tissue fold  21 . The tissue fold  21  is severed by the knife means  30  ( FIG. 4 ) along a severing line C that extends in the direction of the insertion portions  10  and  12  between a third plane P 3  containing leg and joinder portions  2 ,  6  and  14 , and a fourth plane P 4  containing leg and joinder portions  4 ,  8  and  16 . As shown in  FIG. 5 , the clamped severed tissue portions  21   a  and  21   b  are separated by separating the joinder portions  14  and  16  and the associate leg portions relative to the insertion portions  10  and  12  to define the acute angle β. In some cases, the pyeloplasty clip may remain in place permanently, while in other cases, the clip must be removed after the human body has healed (normally, within two to three weeks). In any event, the severed tissue portions  21   a  and  21   b  remain separated until the patient has healed.  
         [0024]     In the modification of  FIGS. 6-9 , fastening means are provided that are operable when the clip is in the clamped condition for fastening together the insertion and leg portions contained in plane P 1  with the insertion and leg portions contained in plane P 2 . More particularly, orthogonally arranged fastening pins  120  integral with the leg portions  102  and  104  are adapted to penetrate and extend through the folded tissue portion  121  into snap fit engagement with locking openings  122  contained in the associated leg portions  106  and  108 , respectively, thereby to fasten securely together the insertion and leg portions of planes P 1  and P 2  during the healing process.  
         [0025]     In some cases, the pyeloplasty clips (i.e., clip  1  of  FIG. 3  and clip  101  of  FIG. 9 ) may be permanently retained in the human body. Alternatively, separation means may be provided for releasing the fastening means, thereby to permit separation of the respective leg and insertions portions, and removal of the clip from the human body. As shown in  FIGS. 10 and 11 , the ends of the flexible string members  140  and  142  are fastened to the insertion portions of the clips. The string portions extend at their other ends from the human body via the openings used by the surgeon during the operation. After the wound has healed, the surgeon may use the strings to open the clamped leg portions for removal of the clip from the body. These string portions are provided only for those pyeloplasty clips that are to be removed.  
         [0026]     According to another feature of the invention, pivot means may be provided for separating the clamped leg portions following the healing process. Referring now to the embodiment of  FIG. 12 , it will be noted that the fastening pins  220  are arranged adjacent the insertion portions  210  and  212  of the clip  201 . A further fastening pin  224  extends between the insertion portions  210  and  212 . Connected with the regions  202   a  and  204   a  of the leg portions  202  and  204  adjacent the joinder portions  214  and  216  are a pair of generally spherical pivot members  250  and  252  that are arranged for engagement with corresponding adjacent regions  206   a  and  208   a  of the leg portions  206  and  208 , respectively. Thus, when the clip  201  is in the illustrated fastened condition, when the leg regions  202   a  and  206   a  are compressed toward the leg regions  204   a  and  208   a , respectively, the fastening pins  220  are snapped out of engagement with the corresponding locking openings  222 . The insertions portions  210  and  212  may be further separated by means of the flexible string members  240  and  242  respectively fastened thereto, thereby to permit removal of the clip from the human body.  
         [0027]     In the modification of  FIG. 13 , the pivot means are defined by a pivot protrusion  350  arranged on each of the leg portions  302  and  304  for engagement with the corresponding leg portion  306  and  308 , respectively. The joinder portions  314  and  316  have generally elliptical configurations, thereby to improve the pivotal operation of the legs during the separation of the fastening pins  320  from their associated locking openings.  
         [0028]     Referring again to  FIGS. 4 and 5 , knife means may be provided on the leg portions  2  and  4  for severing the human tissue clamped within the clip. Thus, following the removal of the severed tissue ( FIG. 4 ) the components in planes P 3  and P 4  (i.e., the joinder ends  14  and  16  with their attached leg portions) need only to be further separated to increase the area of fluid flow at the bifurcation.  
         [0029]     Also, instead of forming all of the portions of the clip from the same material, some sections of the clip (such as the leg portions) could be formed from a rigid non-deformable material, while other sections (such as the insertion portions or the joinder portions) could be formed from a resilient material or a deformable material. Thus, for example, the insertion portions  14  and  16  may be resilient to bias together the components contained in planes P 1  and P 2  of  FIG. 2 .  
         [0030]     While in accordance with the provisions of the Patent Statutes the preferred forms and embodiments of the invention have been illustrated and described, it will be apparent to those skilled in the art that various changes may be made without deviating from the inventive concepts set forth above.