Abstract:
A medical instrument for performing a procedure on body tissue, including: an elongated tool carrier member having a distal end; an operating tool mounted at the distal end; an operating mechanism coupled to the carrier member and the tool for allowing manual operation of the tool; and a stabilizing member carried by the carrier member and including a plate element disposed to bear against the body tissue in order to cause the tool to follow movement of the body tissue. 
     A method for performing a procedure on a body organ that is moving using the medical instrument describe above, by: positioning the instrument so that the plate element of the stabilizing member contacts the organ at a location where the procedure is to be performed; and manually manipulating the operating means in order to perform the procedure while maintaining the plate element of the stabilizing member in contact with the organ.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to medical instruments, and is particularly concerned with improved hand-held instruments for use in surgery. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides an approved medical instrument for performing a procedure on body tissue, and particularly on an organ that is in movement during the procedure. 
     To achieve this goal, the present invention provides a medical instrument for performing a procedure on body tissue, comprising: 
     an elongated tool carrier member having a distal end; 
     an operating tool mounted at the distal end; 
     operating means coupled to the carrier member and the tool for allowing manual operation of the tool; and 
     a stabilizing member carried by the carrier member and including a plate element disposed to bear against the body tissue in order to cause said tool to follow movement of the body tissue. 
     The present invention further provides a method for performing a procedure on a body organ that is moving, using the above-described instrument. This method includes: positioning the instrument so that the plate element of the stabilizing member contacts the organ at a location where the procedure is to be performed; and 
     manually manipulating the operating means in order to perform the procedure while maintaining the plate element of the stabilizing member in contact with the organ. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING 
     FIG. 1A is a perspective view of a first embodiment of a medical instrument according to the invention. 
     FIG. 1B is an elevational, cross-sectional view of the first embodiment. 
     FIG. 2A is a first perspective view of a second embodiment of a medical instrument according to the invention. 
     FIG. 2B is a second perspective view of the second embodiment 
     FIG. 2C is a third perspective view, partly exploded and with certain components remove, of a portion of the second embodiment. 
     FIG. 2D is a fourth perspective view of a portion of the second embodiment. 
     FIG. 2E is a perspective view of one component of the second embodiment. 
     FIGS. 3A and 3B are two perspective views of a modified form of construction of a portion of a medical instrument according to the invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     FIGS. 1A and 1B show a first embodiment of a surgical instrument incorporating the present invention. This instrument is composed of a tube, or rod,  2  connected at its proximal end to a first control element  4  and carrying at its distal end a first gripping jaw  6 . The longitudinal axis of tube  2  defines the axis of the instrument. Jaw  6  is termed herein a hammer jaw. Tube  2  may be made of stainless steel The proximal end of tube  2  may be threaded for connection to a screw that fixes the axial position of control element  4  relative to tube  2  but allows tube  2  to rotate relative to control element  4 . The distal end of tube  2  is connected to first control element  4  in such a manner that tube  2  moves axially together with element  4  but is able to rotate about its axis relative to element  4 . First control element  4  is to be held in the palm of one hand by the operating surgeon during use. 
     Tube  2  slides in a sleeve  12  that carries at its distal end a second jaw  16 , termed herein an anvil jaw. The proximal end of sleeve  12  is fixed to a second control element  14  that can be held in the same hand as control element  4  and can be moved by the thumb and index finger of the operating surgeon during use. By moving control elements  4  and  14  relative to one another along the axis of tube  2 , tube  2  is moved relative to sleeve  12  to effect opening and closing of jaws  6  and  16 . Jaw  6  is dimensioned to engage in sleeve  12  in a manner such that jaw  6  will not rotate relative to jaw  16  about the axis of the instrument. A similar arrangement is provided in my issued U.S. Pat. No. 6,221,083, the disclosure of which is incorporated herein by reference. 
     A further assembly is composed of a sleeve  22 , a sleeve  24  that surrounds, and slides on, sleeve  22 , an arm  26  fixed to sleeve  24 , a pedestal, or disc,  28  fixed to arm  26 , a compression spring  30  adjacent sleeve  24  and surrounding sleeve  22 , a third control element  32  and a leaf spring  34  having a distal end that is fixed to sleeve  22  and a proximal end that is bent inwardly to bear against sleeve  12 . The outer surface of sleeve  12  is provided with a succession of grooves  36 . The inwardly bent proximal end of spring  34  engages in one of grooves  36 . The inner peripheral surface of control element  32  bears against spring  34 , as shown in FIG.  1 B. Control element  32  can be shifted along the axis of the instrument relative to sleeve  22  to vary the radial inward deflection of spring  34 . The greater the inward radial deflection, the higher the engagement force between the inwardly bent proximal end of spring  34  grooves  36  and therefore the higher the force needed to displace sleeve  22  relative to sleeve  12 . Thus, the position of control element  32  along sleeve  22  in the axial direction determines the force needed to move sleeve  12  axially inside sleeves  22  and  24 . After control element  32  has been brought to the desired position along sleeve  22 , it is fixed in that position by a set screw. When the instrument is in use, control element  32  is fixed in position relative to sleeve  22 . As sleeve  22  is displaced manually relative to sleeve  12 , the inwardly bent proximal end of spring  34  moves from one groove  36  to the next. A fourth control element  38  is fixed to the proximal end of sleeve  22 . 
     Sleeve  24  and spring  30  are interposed between two collets  40  and  42  that are both mounted on, and secured to, sleeve  22 . The unit formed by sleeve  24 , arm  26  and pedestal  28  can undergo limited axial movement relative to sleeve  22  while allowing that unit to rotate relative to sleeve  22 . Spring  22  is in frictional contact with sleeve  24  and collet  40  and thus acts as a clutch that opposes, but does not prevent, rotation of that unit relative to sleeve  22 . Before the instrument is placed into use, the initial position of sleeve  24  and the resistance to movement of sleeve  24  relative to sleeve  22  can be adjusted by varying the positions of collets  40  and  42  along sleeve  22 . Then, collets  40  and  42  are fixed in place on sleeve  22  by tightening set screws provided in collets  40  and  42 . 
     In use, pedestal  28  is placed on the organ that is undergoing a surgical procedure at a location where suturing is to be performed. Typically the organ would be the patient&#39;s heart, which is beating. Pedestal  28  is placed on the organ surface, and its position relative to jaws  6  and  16  can be adjusted by manually moving control element  38  relative control to element  4  in the axial direction. Pedestal  28  will follow movements of the organ and thus stabilize the position of jaws  6  and  16  relative to the organ, and particularly relative to the suturing site. Before or after positioning pedestal  28  on the organ surface, a suturing needle can be placed between jaws  6  and  16  and control element  14  can be moved axially relative to control element  4  to grip the needle between the jaws. After the distal end of the instrument has been placed at the suturing site, the needle can be manipulated, as by rotating control element  14  while holding control element  4  steady, to perform a suturing operation. During rotation of sleeve  12 , pedestal  28  remains in position on the organ surface due to the ability of sleeve  24  to rotate relative to sleeve  22 . Pedestal  28  allows jaws  6  and  16  to automatically follow movements of the suturing site without necessarily themselves being in contact with the organ surface. Thus, jaws  6  and  16  can be manipulated as needed while remaining in a stable position relative to the organ surface. Pedestal  28  can also be connected to arm  26  in a manner to be rotatable relative to arm  26 , thereby enhancing the operating flexibility of the instrument. 
     FIGS. 2A,  2 B,  2 C and  2 D show a second exemplary embodiment of the invention that is also in the form of a suturing instrument. Elements in FIGS. 2A-2D that are identical to elements in FIGS. 1A and 1B are given the same reference numerals. Thus, the distal end of the instrument includes hammer jaw  6  connected to a rod (element to in FIGS. 1A and 1B, not visible in FIGS.  2 ), and anvil jaw  16  carried by sleeve  12 . Preferably, jaw  16  is integral with sleeve  12 . 
     Also as in the embodiment of FIGS. 1, sleeve  12  is surrounded, adjacent its distal end, by the assembly that is composed of sleeve  24 , arm  26 , pedestal  28 , spring  30  and collets  40  and  42 , all of which cooperate and function in the manner described above with reference to FIGS. 1, except that here the assembly is mounted on sleeve  12  rather than a sleeve  22 . 
     Sleeve  12  extends through circular passages provided in two discs  44  and  46 , which may be made of Delrin®. Disc  44  is prevented from moving axially relative to sleeve  12  by two further collets  50  and  52  that are fixed to sleeve  12 . However, sleeve  12  is allowed to rotate freely relative to disc  44 . Sleeve  12  is also free to rotate relative to disc  46 . 
     Proximally of disc  46 , a spring  60  is mounted around sleeve  12 . The distal end of spring  60  is held in place relative to sleeve  12  by a collet  62 . The proximal end of spring  60  is secured to a collet  64  that is freely movable relative to sleeve  12 . Collet  62  can be adjusted in position along sleeve  12  to provide the proper compressive stress in spring  60 . 
     Sleeve  12  further extends through passages in two members  70  and  72 , which may be made of stainless steel and which will be described in detail below. These passages are dimensioned to allow sleeve  12  to move freely parallel to its axis and to a limited extent transverse to its axis and to rotate about its axis. However, in order to cause tube  12  to rotate about its axis along with member  72 , a special collet  74  is fixed to sleeve  12  and is provided with a finger  75  that extends into a slot in member  72 , as shown most clearly in FIG.  2 C. 
     The proximal end of sleeve  12  is secured to a collet  76  from which extends a tube  78 . Collet  76  and tube  78  may be made of stainless steel and may be made in one piece. 
     All of the components described thus far, except for members  70  and  72 , constitute a moving assembly, termed herein an armature, that is able to move axially and traversely with the organ that is undergoing a surgical procedure and that is in contact with pedestal  28 . 
     One end of a flexible sheath  80  is fixed in tube  78 . The other end of sheath  80  is fixed in a second tube  84  that is attached to, or integral with, a further collet  86 . Collet  86  is secured to one end of a tube  90 . The opposite end of tube  90  is fixed to member  72  with the aid of a set screw  92  (FIGS.  2 C and  2 D). 
     A nylon line, or metal, preferably stainless steel, cable,  94  is secured at one end to member  70  by a set screw  96 . Cable  94  extends through tube  90 , sheath  80  and a portion of sleeve  12 . In sleeve  12 , cable  94  is connected to an inner tube (not shown; corresponds in function to tube  2  of FIGS.  1 )) that is fixed to, or integral with, jaw  6 . That inner tube may extend proximally to near the proximal end of sleeve  12 , where the inner tube may be secured to cable  94  by, for example, crimping, swaging, or cementing. 
     The armature further includes a tube  100  that contains a video camera and any optics needed to view jaws  6  and  16  and a region surrounding them. Tube  100  is fixed in bores in discs  44  and  46  and is held in place in discs  44  and  46  by suitable set screws (not shown). Since discs  44  and  46  are thus prevented from moving axially relative to sleeve  12 , tube  100  will follow all axial and transverse movements of sleeve  12  but will not follow rotational movement of sleeve  12 . 
     The armature is held in, and movable relative to, a housing assembly that includes a handle  110 , a retaining element  112 , a first tube  116  and a second tube  118  that surrounds the proximal end of tube  116 . Retaining element  112  straddles tube  100  to prevent that tube, and discs  44  and  46 , from following rotational movements of sleeve  12 . Handle  110  and retaining element  112  may each be made of Delrin®. First tube  116  may be provided with a knurled or otherwise roughened portion  122  to facilitate manipulation of tube  116 , as will be described in greater detail below. 
     Referring particularly to FIG. 2C, from which elements  110 ,  112  and  118  have been removed, member  70  is secured to first tube  116  by two screws  130  that engage in holes  132  in first tube  116 . The heads of these screws will be flush with the outer surface of tube  116  so as to not interfere with sliding movement of tube  118  on tube  116 . An axial slot  133  is provided in tube  116  between holes  132  for access to permit installation and adjustment of the position of cable  94 . As shown in FIG. 2D, first tube  116  carries a screw  134  whose head protrudes into a slot in second tube  118 . This screw allows tube  116  to slide axially relative to tube  118  while constraining tubes  116  and  118  to rotate as a unit. 
     Referring to FIGS. 2C and 2D, member  72  is secured to second tube  118  by two screws  136 . As is apparent from FIG. 2D, tube  118  projects in the proximal direction beyond tube  116 . 
     As shown in FIGS. 2A,  2 B and  2 C, a ring  140  is secured to the distal end of tube  118  and bears against handle  110  to prevent axial movement of tube  118  relative to handle  110  in the proximal direction (to the right in FIG.  2 B). 
     The instrument is completed by a sleeve  150  retained between two rings  152  and  154  on tube  118 . Sleeve  150  is free to rotate relative to tube  118 , but rings  152  and  154  are fixed to tube  118 , as by set screws. Ring  154  bears against handle  110  to prevent axial movement of tube  118  relative to handle  110  in the distal direction. Sleeve  150  acts as a shield that prevents the operating physician&#39;s hand from touching tube  118  and hence from being rubbed by tube  118  when it is being rotated. If the operating physician&#39;s hand should touch sleeve  150  while tube  118  is being rotated, sleeve  150  will not rotate. Sleeve  150  may be made of a plastic such as Delrin®. The structure of tube  118  is shown most clearly in FIG.  2 E. Tube  118  includes holes  170  for receiving screws  136 , a longitudinal slot  172  that guides the head of screw  134  and a peripheral slot  174  through which retaining element  112  will extend. Slot  174  is dimensioned to permit the desire to tube  118 . 
     In operation, the instrument is positioned in the manner described above in connection with the embodiments of FIGS.  1 . However, in the embodiment of FIGS. 2, tube  116  is moved relative to handle  110  by gripping roughened area  122 . Axial movement of tube  116  relative to tube  118  acts to open and close jaws  6  and  16 . Rotation of tubes  116  and  118  as a unit acts to rotate sleeve  12  and jaws  6  and  16 . 
     Tube  100  moves axially and transversely with sleeve  12  and the field of view of the associated video camera encompasses the region of action of jaws  6  and  16 . However, tube  100  does not rotate with sleeve  12 . Therefore, even though pedestal  28  is in contact with the body tissue being operated on and is moving therewith, the field of view of the video camera does not move relative to the region of action of jaws  6  and  16 . As a result, the region of action of jaws  6  and  16  appears to be stationary in the image produced by the video camera. 
     Since the armature is movable axially and transversely relative to handle  110  and tube  116 , and sleeve  12  is rotatable relative to handle  110 , the handle and the operating physician&#39;s hand are isolated from the movements of the armature produced by the action of the body tissue on pedestal  28 . In other words, when performing a procedure while viewing the image produced by the video camera in tube  100 , the operating physician has the sensation, both tactilely and visually, that the body tissue is stationary even though, in the case of the heart, it is moving rhythmically. As a result, the procedure can be performed more quickly and with greater ease and accuracy. 
     FIGS. 3A and 3B show another form of construction for an assembly for supporting pedestal  28 . This assembly includes a block  202  having a through bore (not shown) traversed by sleeve  12 . Block  202  is disposed between collets  40  and  42 , which are also mounted on sleeve  12 , and compression spring  30  is interposed between collet  40  and block  202  to bias block  202  against collet  42 . 
     Block  202  has a downwardly projecting portion provided with a second through bore (not shown) that extends at right angles to the first-mentioned through bore. 
     Two cylindrical members  210  and  212 , each provided with a through bore, are disposed on opposite sides of the downwardly projecting portion of block  202 . Block  202  has a recess to accommodate member  212 . A compression spring  216  is interposed between member  212  and the downwardly projecting portion of block  202 . 
     A pin, or rod,  220  extends through the through bores in members  210  and  212 , the second through bore and spring  216  and these parts are held together with the aid of set screws in members  210  and  212  that are screwed down against pin  220 . 
     Collets  40  and  42  can be shifted along sleeve  12  to adjust the position of pedestal  28  relative to jaws  6 , 16 . In addition, the spacing between collets  40  and  42  can be varied to vary the force with which spring  30  presses against block  202 . This determines the force needed to shift block  202 , and thus pedestal  28 , along the axis of tube  12  when the instrument is in use. 
     Pedestal  28  is secured to member  212  by a screw  224  that is screwed into a threaded bore in member  212  and secured to pedestal  28  by a set screw. 
     When collets  40  and  42  are brought to the desired positions along sleeve  12 , set screws in those collets are tightened to secure the collets in position on sleeve  12 . 
     Spring  30  is pressed against collet  42  and block  202  so that rotation of block  202  around sleeve  12  is opposed by the resulting friction forces, which can be varied by varying the spacing between collets  40  and  42 . 
     Similarly, the spacing between member  212  and the downwardly projecting portion of block  202  can be varied, to vary the compression of spring  216 , by adjusting the position of member  212  relative to pin  220 . Rotation of member  212  and pedestal  28  about the axis of pin  220  is opposed by the resulting friction forces between spring  216  and both member  212  and the downwardly projecting portion of block  202 . 
     Thus, both springs  30  and  216  act as clutches. 
     Thus arrangement allows pedestal  28  to lie flat against the surface of the body tissue when the instrument is tilted about the axis of pin  220 . 
     While the embodiments illustrated herein are equipped with jaws for gripping a suture needle or other item, these embodiments can be constructed with other tools, such as a stapler that will be operated in much the same manner as described above. The jaws could also be replaced by forceps that can be used to rotate the wall of an artery to the most favorable orientation for suturing. 
     The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without undue experimentation and without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. The means, materials, and steps for carrying out various disclosed functions may take a variety of alternative forms without departing from the invention. 
     Thus the expressions “means to . . . ” and “means for . . . ”, or any method step language, as may be found in the specification above and/or in the claims below, followed by a functional statement, are intended to define and cover whatever structural, physical, chemical or electrical element or structure, or whatever method step, which may now or in the future exist which carries out the recited function, whether or not precisely equivalent to the embodiment or embodiments disclosed in the specification above, i.e., other means or steps for carrying out the same functions can be used; and it is intended that such expressions be given their broadest interpretation.