Patent Publication Number: US-10307162-B2

Title: Hermetic rotating handle assembly for a surgical clip applier for laparoscopic procedures

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/321,237 filed on Apr. 6, 2010, the contents of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to a novel hermetic rotating handle assembly for a surgical clip applier for laparoscopic or endoscopic procedures. 
     BACKGROUND OF INVENTION 
     Laparoscopic and endoscopic surgical procedures are conducted through a small incision in the skin or natural body orifices. In order to operate, surgeons must use instruments that have a small enough cross section to fit within these small openings and long enough to reach the surgical area within the body. 
     Surgical instruments designed for these procedures are often separated into two components to reduce costs and minimize cross contamination. 
     The first component is a long and narrow disposable portion that is inserted into the small opening during surgery. These disposable components contain surgical tools, such as surgical jaws or surgical clip appliers, dissectors or other instruments, on the end which enters the patient. These disposable components also contain small actuators which control the operation of the surgical tools within the patient. 
     These small actuators on the first component are operatively attached to the second component of these surgical instruments. The second component is a non-disposable control unit for moving the long disposable component within the patient and operating the actuators to control the surgical tools on the disposable component. The second component is often a handle with a trigger. A surgeon may control the movement and placement of the disposable component by holding the handle and operate the small actuators by squeezing the trigger. For instance, a surgeon may squeeze the trigger to place a surgical clip over a vessel. 
     By separating these two components, the risk of cross contamination between separate patients or separate tissues on the same patient is reduced. The non-disposable control unit does not enter the patient and the contaminated long and narrow component is simply disposed after each surgical procedure is completed. In addition, costs are saved since medical providers only need to replace the disposable component between surgical procedures. 
     However, one the problems with currently existing surgical instruments used in these procedures is the possible contamination of the non-disposable control unit. This non-disposable component may still contact patient fluids during surgeries and become contaminated. This may be especially problematic for handle and trigger assemblies. In order for a trigger to be squeezed and moveable, these assemblies have openings to their internal structures. 
     One solution to this problem is for medical providers to autoclave and sterilize each non-disposable component after each surgical procedure. However, the time needed to autoclave and sterilize these non-disposable handle and trigger assemblies is significantly high due to the need to sterilize the internal structures. This sterilization increases maintenance costs for medical providers. Current surgical clip appliers include many disposable handles since they cannot be sterilized effectively, even with hours in an autoclave. 
     According, the subject invention is a non-disposable hermetically-sealed handle assembly with a rotating trigger for use with disposable components, such as surgical clip appliers. The hermetic seal on the handle assembly prevents any patient fluids and other bioburden from entering the internal structures. This reduces the possibility of cross-contamination and the costs of sterilization. 
     SUMMARY OF THE INVENTION 
     There are additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of the description and should not be regarded as limiting. 
     The subject invention discloses an endoscopic surgical tool comprising, a housing comprising an upper portion and a handle; an actuating mechanism contained within the housing along a first axis, wherein the actuating mechanism is adapted to operatively couple to a disposable external shaft that extends away from the housing along a first shaft axis from a proximal end to a distal end, wherein the first axis and the first shaft axis are substantially parallel; a lever coupled at a proximal end to the actuating mechanism and extending in a downward direction, wherein the lever is pivotably coupled at a distal end to an internal shaft that extends along a second shaft axis that is substantially perpendicular to the first shaft axis; a first end of the internal shaft extending through a first opening in the housing proximate to the top of the handle, and further extending through a central opening of a first disc spring; a second end of the internal shaft extending through a second opening in the housing proximate to the top of the handle, and further extending through a central opening of a second disc spring, wherein the first opening and the second opening are substantially parallel with each other; a first trigger shaft comprising a first substantially semi-spherical top portion coupled to the first end of the internal shaft after extending through the first disc spring, wherein the first trigger shaft further comprises a first substantially half-cylindrical lower portion with a first substantially flat surface, wherein the first disc spring provides a first seal about the first end of the internal shaft by providing a first compressive force on the first substantially semi-spherical top portion of the first trigger shaft and an opposing second compressive force on the exterior surface about the first opening in the housing; a second trigger shaft comprising a second substantially semi-spherical top portion coupled to the second end of the internal shaft after extending through the second disc spring, wherein the second trigger shaft further comprises a second substantially half-cylindrical lower portion with a second substantially flat surface, wherein the second disc spring provides a second seal about the second end of the internal shaft by providing a third compressive force on the second substantially semi-spherical top portion of the second trigger shaft and an opposing fourth compressive force on the exterior surface about the second opening in the housing, wherein the first and second substantially flat surface of the first and second trigger shafts couple to form a substantially cylindrical lower trigger shaft defining a longitudinal axis; a hollow substantially cylindrical trigger grip coupled over the cylindrical lower trigger shaft; wherein application of compressive force to the trigger grip towards the handle rotates the cylindrical lower trigger shaft about the longitudinal axis in a first direction to rotate the first and second ends of the internal shaft in a direction away from the second shaft axis, wherein rotation of the internal shaft pivots the coupled lever to operate the actuating mechanism. 
     In another embodiment of the subject invention, the first and second trigger shafts comprise complementary configurations. 
     In another embodiment of the subject invention, the external shaft comprises a cartridge containing surgical clips. 
     In another embodiment of the subject invention, the distal end of the external shaft is adapted to receive an end effector. 
     In another embodiment of the subject invention, the end effector comprises a distally attached surgical jaws assembly. 
     In another embodiment of the subject invention, the first and second disc springs comprise conical spring washers. 
     In another embodiment of the subject invention, the housing is non-disposable. 
     In another embodiment of the subject invention, the cylindrical lower trigger shaft rotates about the longitudinal axis in a second direction, opposite the first direction, when the trigger is released. 
     In another embodiment of the subject invention, the housing comprises a single piece. 
     In another embodiment of the subject invention, the housing comprises two coupled pieces with complementary configurations. 
     The subject invention also discloses a hermetically sealed handle assembly for a surgical clip applier comprising: a housing comprising an upper portion and a lower handle; an actuating mechanism contained within the upper portion of the housing that controls a disposable cartridge containing surgical clips; a shaft extending from the housing containing rotating means so as to permit rotation of the shaft about an axis that extends substantially longitudinally through the shaft, wherein the shaft rotates in a first direction about an axis that extends substantially longitudinally through the shaft when a gripping force is applied to the shaft, and further wherein the actuating mechanism within the housing is coupled to the shaft such that rotation of the shaft operates the actuating mechanism. 
     There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. These together with other objects of the invention, along with the various features of novelty, which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Advantages of the present invention will be apparent from the following detailed description of embodiments thereof, which description should be considered in conjunction with the accompanying drawings, in which: 
         FIG. 1  illustrates an exploded view of a hermetically-sealed rotating trigger and handle assembly for a clip applier. 
         FIG. 2  illustrates a front view of the hermetically-sealed rotating trigger and handle assembly. 
         FIG. 3  illustrates a side cross-sectional view of the hermetically-sealed rotating trigger and handle assembly along line “A” of  FIG. 2 . 
         FIG. 4  illustrates a cross-sectional front internal view of the hermetically-sealed rotating trigger and handle assembly. 
         FIG. 5  illustrates a side view of the hermetically-sealed rotating trigger and handle assembly. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     While several variations of the present invention have been illustrated by way of example in particular embodiments, it is apparent that further embodiments could be developed within the spirit and scope of the present invention, or the inventive concept thereof. However, it is to be expressly understood that such modifications and adaptations are within the spirit and scope of the present invention, and are inclusive, but not limited to the following appended claims as set forth. 
       FIGS. 1-5  illustrate a hermetically-sealed handle and trigger assembly  101  with a handle  102  and a rotating trigger  103  for a surgical clip applier (not shown).  FIG. 3  illustrates a side cross-sectional view of the handle and trigger assembly  101  as shown by lines “A” of  FIG. 2 . The hermetic seal on the handle and trigger assembly  101  prevents any patient fluids from entering the internal structures. This reduces the possibility of cross-contamination and the costs of sterilization, which allows the handle and trigger assembly  101  to be non-disposable. 
     The rotating trigger  103  rotates in a first direction that is substantially perpendicular to the length of the trigger  103  when squeezed in a direction towards handle  102 . The rotating trigger  103  rotates in a second direction, opposite the first direction, when released and moving away from handle  102 . 
     The elements of the handle and trigger assembly  101  include an external housing  107  that is formed by a hollow left half section  305  and a hollow right half section  306 . Hollow left half section  305  and hollow right half section  306  are complementarily shaped to each other. The housing  107  may be made of a polycarbonate, ABS, stainless steel or other suitable material known to those skilled in the art. The separate half sections  305  and  306  may be attached together by adhesives, fasteners, welding, or other attachment means known to those skilled in the art. 
     Left half section  305  has an upper left housing  305   a , a lower left half-handle housing  305   b  and a hollow left hinge housing  305   c . Hollow left hinge housing  305   c  has a traversing left opening  305   d.    
     Right half section  306  has an upper right housing  306   a , a lower right half-handle housing  306   b , and a hollow right hinge housing  306   c . Hollow right hinge housing  306   c  has a traversing right opening  306   d.    
     An actuator mechanism  104  is contained within upper left housing  305   a  and upper right housing  306   a . Once the left half section  305  and the right half section are connected to form the external housing  107 , the upper left housing  305   a  and the upper right housing  306   a  form housing opening  106 . This opening  106  contains the actuator mechanism  104  and allows it to control the disposable cartridge containing surgical clips and a plurality of distal end effectors. The internal actuator mechanism  104  of the subject invention may be any mechanism, known to those skilled in the art, which operates a cartridge containing surgical clips and a distal end effector that is controllable with pivotable lever  105 . 
     A pivotable lever  105  has a top end  105   a  and a bottom end  105   b . The top end  105   a  of lever  105  is operatively connected to actuator mechanism  104 . Trigger shaft  310  is substantially perpendicular to lever  105 . The top end  105   a  of lever  105  may pivot about the pivot point of bottom end  105   b  by rotating around the axis of trigger shaft  310 . 
     Trigger shaft  310  has a left end  310   a  and a right end  310   b . Trigger shaft bearings  309  are placed over left end  310   a  and right end  310   b.    
     Left end  310   a  passes through left opening  305   d  of left hinge housing  305  and then passes through a spring seal washer  311 . A left hinge element of the trigger  304  has an upper semi-spherical portion  304   a  with an indentation  304   b  that houses the spring seal washer  311 . After passing through spring seal washer  311 , left end  310   a  of trigger shaft  310  attaches within indentation  304   b  of the left hinge element of the trigger  304 . 
     Right end  310   b  passes through left opening  306   d  of right hinge housing  306  and then passes through a spring seal washer  311 . A right hinge element of the trigger  303  has an upper semi-spherical portion  303   a  with an indentation  303   b . After passing through spring seal washer  311 , right end  310   b  of trigger shaft  310  attaches within indentation  303   b  of the right hinge element of the trigger  303 . 
     Right hinge element of the trigger  303  has a lower trigger spine  303   c  attached to upper semi-spherical portion  303   a . Lower trigger spine  303   c  has a half-cylindrical shape with a substantially flat face  303   d.    
     Left hinge element of the trigger  304  has a middle trigger spine  304   c  attached to upper semi-spherical portion  304   a . The upper section of middle trigger spine  304   c , proximate to semi-spherical portion  304   a , has a half-cylindrical shape with a substantially flat face  304   d . The lower section of middle trigger spine  304   c , distal to semi-spherical portion  304   a , has a substantially cylindrical shape. Left hinge element of the trigger  304  also has a lower substantially cylindrical trigger spine  304   e  attached to middle trigger spine  304   c.    
     As left end  310   a  attaches within indentation  304   b  and right end  310   b  attaches within indentation  303   b , substantially flat face  303   d  is attached to the opposing substantially flat face  304   d  above the lower section of middle trigger spine  304   c . Once joined, flat faces  303   d  and  304   d  form a substantially cylindrical shape that is substantially equivalent in diameter to the lower section of middle trigger spine  304   c . The right hinge element of the trigger  303  is torsionally fixed to the right end  310   b  of trigger shaft  310 . The left hinge element of the trigger  304  is torsionally fixed to the left end  310   a  of trigger shaft  310 . 
     A hollow substantially cylindrical trigger grip  301  has a top opening  301   a  and a bottom opening  301   b . The trigger grip  301  is placed over the connected right hinge element  303  and left hinge element  304  through top opening  301   a . The lower trigger spine  304   e  of left hinge element of the trigger  304  passes through bottom opening  301   b , a bushing  307 , a retaining ring  308  and is attached to an end cap  302 . 
       FIG. 5  illustrates the rotating trigger in the resting position  103   a  and the squeezed position  103   b . When a user applies gripping force to the trigger grip  301  by squeezing rotating trigger  103 , the trigger grip  301 , the lower trigger spine  303   c , and the middle trigger spine  304   c  all begin to rotate about the axis of trigger shaft  310  in either a clockwise or counterclockwise direction. As trigger spine  304   c  begins to rotate, the left end  310   a  of trigger shaft  310  also begins to rotate in the same direction. Concurrently, as trigger spine  303   c  begins to rotate, the right end  310   b  of trigger shaft  310  also begins to rotate in the same direction. The rotation of trigger shaft  310  causes the top end  105   a  of lever  105  to begin to pivot about the about the pivot point of bottom end  105   b  by rotating around trigger shaft  310 . The pivoting of top end  105   a  operates actuator mechanism  104  which controls the surgical clip applier distal end effector (not shown). Thus, application of gripping force to the trigger  103  operates the surgical clip applier. 
     Once a user releases the trigger grip  301 , the trigger grip  301 , the lower trigger spine  303   c , and the middle trigger spine  304   c  all begin to rotate about the axis of trigger shaft  310  in the opposite clockwise or counterclockwise direction The trigger shaft  310  rotating in an opposite direction causes the top end  105   a  of lever  105  to begin to pivot in an opposite direction about the about the pivot point of bottom end  105   b  by rotating around trigger shaft  310 . The opposite pivoting of top end  105   a  releases the actuator mechanism  104  which controls the surgical clip applier distal end effector (not shown). Thus, release of gripping force to the trigger  103  stops the operation of the surgical clip applier. 
     The rotating trigger  103  reduces the gripping force necessary to fully pivot lever  105  to operate actuator mechanism  104  to operate a disposable surgical clip applier (not shown) to fully ligate a vessel or other tissue. In one embodiment of the subject application the gripping force required to fully actuate for full ligation is reduced from 25 lbs to 5 lbs. 
     The trigger assembly  101  and the rotating trigger  103  remain hermetically sealed in the resting  103   a  and squeezed  103   b  positions. A spring seal washer  311  around the left end  310   a  of trigger shaft  310  provides a compressive force against semi-spherical portion  304   a  and an opposing compressive force against housings  305   a  and  305   c . Another spring seal washer  311  around the right end  310   b  of trigger shaft  310  provides a compressive force against semi-spherical portion  303   a  and an opposing compressive force against housings  306   a  and  306   c . These opposing compressive forces on both sides and surrounding trigger shaft  310  provide an air seal between trigger  103  and housing  107 . This air seal is maintained during rotation of trigger  103  from the resting  103   a  to squeezed position  103   b.    
     Handle and trigger assembly  101  does not require a change of the trigger body volume inside the handle when the trigger  103  is gripped or released. This allows the handle and trigger assembly  101  to contain a completely air tight seal, making the assembly  101  infinitely reusable while reducing sterilization time. This also minimizes autoclave ineffectiveness and the possibility of cross contamination from patient to patient. 
     In embodiments of the subject invention, the washer seals  311 , the bushing  307 , the retaining ring  308  and the trigger shaft bearings  309  may be composed of titanium, plastic, steel or any combination thereof. In another embodiment of the subject invention, the washer seals  311 , the bushing  307 , the retaining ring  308  and the trigger shaft bearings  309  may all be composed of a unitary construction.