Abstract:
Disclosed is a minimally invasive surgical instrument that may be used in hand-assisted laparoscopic surgeries. The device is multifunctional surgical instrument that may be mounted directly on a surgeon&#39;s fingertip and inserted through an incision to allow the surgeon to manipulate tissue during a surgical procedure.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    The present application claims the benefit of U.S. Provisional patent application serial No. 60/447,446, filed on Feb. 14, 2003, the contents of which are hereby incorporated herein by reference.  
         [0002]    The present application is also related to U.S. patent applications, attorney docket no. END-5015NP, Ser. No. [______] and END-5017NP, Ser. No. [______] filed concurrently herewith. 
     
    
     
       FIELD OF THE INVENTION  
         [0003]    The present invention relates in general to the performance of a variety of surgical steps or procedures during surgical operations and, more particularly, to methods and apparatus for utilizing fingertip surgical instruments as an integral part of such surgical procedures to expedite and facilitate the surgical procedure and to extend a surgeon&#39;s sense of “feel”.  
         BACKGROUND OF THE INVENTION  
         [0004]    Abdominal surgery typically involves an incision in the abdominal wall large enough to accommodate a surgeon&#39;s hands, multiple instruments, and illumination of the body cavity. While large incisions simplify access to the body cavity during a surgery, it also increases trauma, requires extended recovery time, and can result in unsightly scars. In response to these drawbacks, minimally invasive surgical methods have been developed.  
           [0005]    In minimally invasive abdominal surgery, or laparoscopic surgery, several smaller incision are made into the abdominal wall. One of the openings is used to inflate the abdominal cavity with gas, which lifts the abdominal wall away from underlying organs and provides space to perform the desired surgery. This process is referred to as insufflation of the body cavity. Additional openings can be used to accommodate cannulas or trocars for illuminating and viewing the cavity, as well as instruments involved in actually performing the surgery, e.g., instruments to manipulate, cut, or resect organs and tissue.  
           [0006]    While minimally invasive surgical methods overcome certain drawbacks of traditional open surgical methods, there are still various disadvantages. In particular, there is limited tactile feedback from the manipulated tissue to the surgeon hands. In non-endoscopic surgery, a surgeon can easily verify the identification of structures or vessels within a conventional open surgery incision. In particular the surgeon normally uses the sense of feel to verify the nature of visually identified operational fields. Further, in endoscopic surgery, tissue that is to be removed from the body cavity must be removed in pieces that are small enough to fit through one of the incisions.  
           [0007]    Recently, new surgical methods have been developed that combine the advantages of the traditional and minimally invasive methods. It is sometimes referred to as hand assisted laparoscopic surgery (“HALS”). In these new methods, small incisions are still used to inflate, illuminate, and view the body cavity, but in addition, an intermediate incision is made into the abdominal wall to accommodate the surgeon&#39;s hand. The intermediate incision must be properly retracted to provide a suitable-sized opening, and the perimeter of the opening is typically protected with a surgical drape to prevent bacterial infection. A sealing mechanism is also required to prevent the loss of insufflation gases while the surgeon&#39;s hand is either inserted into or removed from the body cavity though the retracted incision.  
           [0008]    While the hand provides a great deal of flexibility and retains the surgeon&#39;s sense of feel, fingers in themselves have limits as to their usefulness. Fingers lack the delicacy to pick up fine tissue. Fingers require making larger divisions when dissecting tissue. Fingers are subject to injury when holding tissue while energy modalities, such as ultrasound or RF, are used to treat the surgical site.  
           [0009]    Traditional instruments intended for conventional surgery i.e. forceps and graspers are too large for the limited body cavity environment. Traditional instruments also present the problem of being brought into and out of the laparoscopic site causing time-delaying deflation and re-insufflations of the body cavity. Laparoscopic equivalent instruments are delivered through a body wall port and have limited access to tissue.  
           [0010]    U.S. Pat. Nos. 5,42,227; 6,149,642; 6,149,642; 5,925,064 disclose various aspects of laparoscopic surgery and fingertip devices for surgeon use.  
           [0011]    With the advance represented by HALS procedures there is a need for improved fingertip surgical instrumentation that can take advantage of the increased freedom created by having a hand inside the body cavity. The present invention overcomes the disadvantages of the prior art and provides the surgeon with a cost effective, yet efficiently flexible surgical instrument.  
         BRIEF SUMMARY OF THE INVENTION  
         [0012]    This need is met by the methods and apparatus of the present invention wherein an a surgical device defined by attachment to a surgeon&#39;s hand such that it is used to operate within an operational field. 
       
    
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0013]    These and other features, aspects, and advantages of the invention will become more readily apparent with reference to the following detailed description of a presently preferred, but nonetheless illustrative, embodiment when read in conjunction with the accompanying drawings. The drawings referred to herein will be understood as not being drawn to scale, except if specifically noted, the emphasis instead being placed upon illustrating the principles of the invention. In the accompanying drawings:  
         [0014]    [0014]FIG. 1 a  is a cut-away perspective view of an exemplary use of the present invention;  
         [0015]    [0015]FIG. 1 b  is a cut-away view of one embodiment of the invention attached to a surgeon&#39;s finger;  
         [0016]    [0016]FIG. 2 is a perspective of one embodiment of the invention attached to a surgeon&#39;s fingertip;  
         [0017]    [0017]FIGS. 3 a  is a perspective view of one embodiment of the invention having a scissors working element and a pushbutton actuation mechanism;  
         [0018]    [0018]FIG. 3 b  is a cut-away elevation view of the pushbutton actuation mechanism of FIG. 3 a;    
         [0019]    [0019]FIG. 3 c  is a perspective view of a one-finger operation scissors working element;  
         [0020]    [0020]FIG. 3 d  is a perspective view of a two-finger operation scissors working element;  
         [0021]    [0021]FIGS. 4 a - b  are perspective views of alternate embodiments of the invention having a tissue grasper working element;  
         [0022]    [0022]FIG. 5 is a perspective view of an alternate embodiment of the invention having a clip applier working element;  
         [0023]    [0023]FIGS. 6 a - c  are a perspective views of alternate embodiments of the invention RF-energized working element;  
         [0024]    [0024]FIGS. 7 a - f  are perspective views of an alternate embodiment of the invention having a monopolar working element that are interchangeable;  
         [0025]    [0025]FIG. 8 is a perspective view of an alternate embodiment of the invention having a tissue grasper working element and a thumb-actuated closure mechanism;  
         [0026]    [0026]FIG. 9 is a perspective view of an alternate embodiment of the invention having a suction/irrigation working element;  
         [0027]    [0027]FIG. 10 a  is an elevation view of an alternate embodiment of the invention having a tissue grasper working element and a spring-biased moveable jaw;  
         [0028]    [0028]FIG. 10 b  is a cut-away elevation view of the embodiment of the invention shown in FIG. 10 a;    
         [0029]    [0029]FIG. 11 is a cut-away elevation view of an alternate embodiment of the invention having a needle holder working element;  
         [0030]    [0030]FIGS. 12 a - d  are alternate views of an alternate embodiment of the invention having a right angle dissector working element;  
         [0031]    [0031]FIG. 13 a - c  are alternate views of an alternate embodiment of the invention having a scissors working element;  
         [0032]    [0032]FIG. 14 a  is a cut-away perspective view of an exemplary use of the present invention having a ultrasonic working element;  
         [0033]    [0033]FIG. 14 b - c  are views of a representative transducer assembly for use in the embodiment of FIG. 14 a ; and  
         [0034]    [0034]FIG. 14 d  is a perspective view of a exemplary transducer and blade assembly for use in the embodiment of FIG. 14 a.    
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0035]    Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description.  
         [0036]    The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention.  
         [0037]    It is understood that any one or more of the following-described embodiments, expressions of embodiments, examples, methods, etc. can be combined with any one or more of the other following-described embodiments, expressions of embodiments, examples, methods, etc.  
         [0038]    While the methods and apparatus of the present invention are generally applicable to the performance of these surgical procedures during any operation, they are particularly applicable to their performance during HALS procedures and, accordingly, will be described herein with reference to this invention.  
         [0039]    Referring now to FIG. 1 a , the environment for performing an endoscopic surgical procedure within an abdomen  100  is illustrated. A means for providing hand access, such as a lap disc  110 , for example, model LD111 available from Ethicon Endo-Surgery, Cincinnati, Ohio, is placed into the abdominal wall. A surgeon places his arm and gloved hand  120  through the lap disc and into the abdomen cavity  100 . The index finger  130  (although any finger can be used) is capped with a finger device with a surgical instrument  110  having (in a generic sense) a working element  105 . The working element  105  can be used to manipulate tissue, such as for example, a blood vessel  170  during a laparoscopic procedure.  
         [0040]    [0040]FIG. 1 b  is a cut-away view of a fingertip instrument  110  having a finger-insert member or shell  125  defining a cavity  126  for releasably receiving a finger  130  fully inserted into the shell  125  with fingertip  135  resting at the distal end of cavity  126 . Preferably, shell  125  and cavity  126  are constructed to compressively engage the surgeon&#39;s fingertip  135 . Cavity  126  may also have a friction material on its internal surface to provide further gripping capabilities to secure the surgeon&#39;s fingertip  135 . Shell  125  may also comprise a mounting means (not shown), such as a strap, to securely fasten the shell  125  to the surgeon&#39;s finger  130 . Fingertip instrument  110  may be reusable or disposable and made from a biocompatible material such as plastic or stainless steel. Working element  105  may be constructed from a plastic or stainless steel depending upon its particular function as is described in more detail below.  
         [0041]    [0041]FIGS. 1 c - d  illustrate alternate configurations of shell  125  to meet varying surgeon requirements and sizes of fingers. FIG. 1 c  is a side view of shell  125  illustrating an opening  440  to enable the surgeon to feel tissue while fingertip instrument  110  is attached. FIG. 10 d  is useful to accommodate varying finger sizes by providing a rim break  450  to allow shell  125  to deflect thereby fitting a greater range of finger sizes. FIG. 1 e  illustrates a two-piece snap band  470  that overlaps and snaps in place to accommodate finger size variations. Other configurations of shell  125  embodies side walls of a flexible nature i.e. elastomer or weave pattern that allow the Instrument  110  to be folded to enable its delivery into the body cavity through other devices, such as a trocar.  
         [0042]    Alternate embodiments of the fingertip devices incorporate an adjustable strap to accommodate a greater finger size range. The profiles have also been adapted to enable alternate actuation means.  
         [0043]    [0043]FIG. 2 is a perspective of instrument  110  having a blunted working element or extension tip  150  protruding from the distal end of finger insert member  125 .  
         [0044]    Extension tip  150  can be conveniently used for non-sharp piercing, elevating or dividing tissue.  
         [0045]    [0045]FIG. 3 a - d  illustrate a third embodiment of a fingertip surgical instrument  125  having a working element defining a scissors element. FIG. 3 a  illustrates a single finger operated scissors having a spring loaded push button  210  driving scissor halves  222  and  221  apart from each other. FIG. 3 b  shows a cross section of button  210  mechanism consisting of wedge Shaft  240  that connects to the button  210  at joint  230 . Wedge shaft  240  is captured within the pocket  215  cut into shell  125 . By pressing button  210 , spring  220  compresses driving the wedge  240  between scissor halves  221 ,  222  that have an elastic band  245  stretched between posts  250  to apply a return force. FIG. 3 c  illustrates a one-finger operation fingertip instrument having a scissors working element. A scissor half  221  is fixed to the shell  125  and the other scissor half  222  is operable by moving thumb lever  255 . FIG. 3 d  illustrates a two-finger operated working element where the thumb  260  and other finger  265  operate lever arms associated with scissor halves  221 ,  222 .  
         [0046]    [0046]FIGS. 4 a - b  illustrate a fourth embodiment of fingertip instrument  110  having a tissue pick-up working element. In FIG. 4 a , a stationary arm  270  opposes a flexible arm  275  attached to shell  110  by a rigid band  280 . Thumb  260  actuates the flexible arm  275  to engage tissue between teeth  290  and  291 . Teeth  290  and  291  may have any variety of tissue grasping configurations, such as interlocking or serrated. FIG. 4 b  illustrates a Babcock shape  298  as an example of the many other applicable well known forms.  
         [0047]    [0047]FIG. 5 illustrates a fifth embodiment of fingertip instrument  110  having a clip applier working element. Frame  300  consists of a stationary jaw  301  and a moveable jaw  302 , which is actuated by lever  260 . Jaws  301  and  302  are configured to hold a clip  305 . The surgeon may navigate clip  305  around tissue or a blood vessel and actuate lever  260  to deform clip  305  around the tissue.  
         [0048]    [0048]FIGS. 6 a - c  illustrate a sixth embodiment of fingertip instrument  110  having an RF working element. FIG. 6 a  illustrates an electrical insulating conformable RF finger cuff  310  containing electrodes  315 . Fingertip instrument  110  with working element  105  slips over finger cuff  310  and electrodes  315  mate with contacts  320  contained within the cavity  126  of instrument  110 . FIG. 6 b  illustrates two electrodes  315  contained on the thumb and index finger, for example, that interface with an RF pick-up or bipolar forceps  316  via contacts  315   a  and applying an insulator  317  between the two tissue contacting elements  318 . FIG. 6 c  discloses a bipolar application using two RF finger cuffs  310 , one electrode  315  on index finger  130  and one electrode  315  on thumb  260 . In this manner, RF energy would be directly applied to tissue  340 . In each of the described embodiments, RF energy is provided to the finger cuffs via wires, that may be, for example, attached to the surgeon&#39;s arm and connected to a standard RF generator. The delivery of RF energy to the finger cuffs would be controlled by an external means such as a foot pedal (not shown). In all cases, the RF applications may be monopolar with one electrode and a grounding pad (not shown) or bipolar.  
         [0049]    [0049]FIGS. 7 a - f  illustrate a seventh embodiment of the fingertip instrument  110  having a monopolar working element  460 . In this embodiment, an insulated finger cuff  310  comprises an electrode  315  connected to an RF generator via conductor  330 . Finger cuff  310  inserts within shell  125  and electrode  315  interfaces with contact  316  that is mechanically connected to button  317 . Contact  316  electrically connects with monopoloar working element  460  via conductor  318  molded within shell  125 . Button  317  may be any number of conventional mechanical devices for causing contact  316  to make electrical contact with electrode  315  (FIG. 7 b ). Button  317  enables the surgeon to activate working element  460  via thumb. Thumb  160  (not shown) to activate the Tip Electrode  460  if a hand switch is desired. As would be apparent to those skilled in the art monopolar working element  460  may also be configured for bipolar operation including cut and coagulation operation. In another instance, working element  460  may be removably attached to shell  125  to allow for multiple working elements to be used without having to change finger tip instrument  110 . Working element  460  may interface with conductor  318  via a contact terminal  480  positioned within shell  125 . Other possible working elements  460  are illustrated in FIGS. 7 d - f.    
         [0050]    [0050]FIG. 8 illustrates an eighth embodiment of the fingertip instrument  110  having a grasper working element  400 . Grasper  400  has two moveable jaws that are controlled via a thumb-actuated push button  350  for activating grasper  400 . In one instance push button  350  may activate an actuation tube as part of tube-in-a-tube construction, well known to those skilled in the art, to cause the jaws of grasper  400  to grab and release tissue.  
         [0051]    [0051]FIG. 9 illustrates a ninth embodiment of the fingertip instrument  110  having a suction/irrigation working element  410 . Suction and irrigation lines  411  and  412  travel from a standard suction/irrigation supply via the surgeon&#39;s arm and terminate at corresponding actuation buttons  420  and  430 . The surgeon may selectively manipulate working element  410  within the operation site and cause fluid suction or irrigation via thumb  260  actuation as required during the medical procedure.  
         [0052]    [0052]FIG. 10 illustrates a tenth embodiment of the fingertip instrument  110  having a tissue forceps  500  as a working element. As shown in FIGS. 10 a - b , tissue forcep  500  comprises a stationary jaw  520  and a moveable jaw  570  that is acutated by a thumb  260 . FIG. 10 also illustrates an alternate configuration of shell  560 . In this instance shell  560  is open in design and a mechanical fastener, such as a strap  510 , securely fastens shell  560  to finger  265 .  
         [0053]    Referring to FIG. 10 b , stationary jaw  520  has block end  530  that is secured by a stationary jaw pin  540  or equivalent cross member into a body recess  550  of the shell  560 . The movable jaw  570  rotates about a pivot pin  580  at the proximal end of the jaw  570 . Jaw  570  is spring biased away from shell  560  by means of spring  575  positioned within recess  565 . Ledge  590  acts as a stop for jaw  570  and clearance  585  determines the maximum jaw opening  555  when jaw  570  is fully retracted.  
         [0054]    [0054]FIG. 11 is an alternate working element in the form of a needle holder  600  in conjunction with the embodiment of FIG. 10. Needle holders  600  may also include a ratcheting mechanism well known to the instrument making art to accommodate varying needle sizes and/or clamping pressures (not shown).  
         [0055]    Generally, the working element may take any number of configurations that are readily observable in surgical catalogs, for example, the Codman Surgical Product Catalog, Division of Johnson and Johnson, New Brunswick, N.J.  
         [0056]    Referring to FIGS. 12 a - d  a right angle dissector  700  is shown. Jaws  705  are caused to spread when the actuator ball  710  is moved from a first position (FIG. 12 c ) distally to a second position (FIG. 12 d ). Jaws  705  emanate from a common end  720  that is secured to the shell  560  by a pin  725  that is anchored into a mating pin recess  730  of shell  560 . An actuation arm  715  is connected to shell  560  via pivot pin and concentric pivot hole  740 . Surgeon thumb  260  actuates pivot arm  715  via thumb pad  712 . When pivot arm  715  is actuated, ball  710  is forced distally and spreads jaws  705  and initial ball contact points  751 ,  752  move to diametric tangential positions  753 ,  754  as ball  710  slides along the surface faces  760  to achieve the maximum jaw spread  765 . The jaws  705  may have a surface break  770  that enables ball  710  to stay in its most distal position without having the surgeon maintain constant pressure on the thumb pad  712 .  
         [0057]    [0057]FIGS. 13 a - c  represent still an alternate embodiment of a working element in the form of a scissors in conjunction with the embodiment of FIG. 10 with like reference numerals having the same function. Scissor working element  800  includes a stationary jaw  810  and a moveable jaw  825 . The cutting faces  840  (FIG. 14 a ) are contoured to established industry standards for tissue cutting performance. To prevent the cutting faces  840  to separate and leaving gaps in the resulting tissue cut, a raised rib  845  assist the intended alignment of the moveable scissor jaw  825  with respect to stationary jaw  810 .  
         [0058]    [0058]FIGS. 14 a - d  illustrates an alternate embodiment of the fingertip instrument  110  having an ultrasonic scalpel or blade  1130  as a working element. The ultrasonic instrument includes a transducer section  1120  that is molded or otherwise housed into the finger shell  125  and a blade  1130  that attaches to the transducer  1120  and extends distally to contact and manipulate tissue. A cable, not shown, extends from the instrument back along the hand and arm through the hand port  100  to an ultrasonic generator.  
         [0059]    The ultrasonic blade  1130  is envisioned as a spatula or spoon-like device as depicted in FIG. 14 a . The instrument can be used without ultrasonic energy for fine dissection and creating planes. With ultrasound energy applied, the blade can be used to cut and close small bleeders by pressing against them.  
         [0060]    A second instrument  1140  has a passive tine that would be mounted with another finger shell or ring to the thumb as depicted in FIG. 14 a . Together the thumb and index finger instruments can be used as a pair of tissue pickups. In this configuration, they are a natural extension to pick up items/tissue between the index finger and the thumb. With the ultrasonic energy activated the two instruments would act like a pair of RF-bipolar forceps. However, the ultrasonic fingertip forceps provide the benefits of ultrasound: minimal lateral thermal damage, less stick and char, no stray electrical currents, coagulation and transection in one application, and multi-functionality.  
         [0061]    Another embodiment not shown incorporates the passive tine and ultrasonic active tine into one finger shell instrument similar to the embodiments shown in FIGS. 10-12. The instrument would likely be placed on the index finger. The thumb would be used to press the passive tine onto the active tine. Again with out ultrasound, the forceps would act as a simple tissue pick-up to aid in dissection. With the ultrasound applied, the forceps would be used to coagulate and transect small vessels.  
         [0062]    The ultrasonic transducer in  1120  is designed as a conventional Langevin bolted transducer well known by those practicing in the art. The actual ultrasonic transducer  1200  shown in FIG. 14 b  consists of a stack of piezoelectric disks  1210  connected to metallic ends  1230 , referred to as end masses. The piezoelectric elements are driven by a generator that tracks the desired resonant frequency as it changes with temperature and load and also supplies electrical power at the resonant frequency. The electrical energy is transformed into ultrasonic energy by the piezoelectric elements.  
         [0063]    The piezoelectric elements contract and expand creating alternating periods of compression and tension. Because common piezoelectric materials are ceramics, they are weak in tension. Therefore the piezoelectric elements are pre-compressed by a bolt that is generally tightened between the two metallic end mass. The center bolt  1220  is shown in FIG. 14 c  as engaging threads in both end masses  1230 . Often the center bolt passes through one end mass and through the center of the piezoelectric elements that are typically ring-shaped.  
         [0064]    The shank of the bolt engages threads in the opposite end mass and tightened to apply the pre-compression.  
         [0065]    The transducer  1120  is sized to be on the order of the distal and middle phalanges of the index finger. The length is on the order of two inches or less and the diameter should be nominally ½ inch or less. The actual length and diameter depend on the selected frequency of operation, number of piezoelectric elements, metals used in the end masses, size of compression bolt, and other design specifics.  
         [0066]    The transducer could be designed as either a ¼ wavelength or a ½ wavelength. The transducer could be designed with more ¼ wavelengths, but a goal in this application it to keep the transducer small and non-intrusive. The ¼ wavelength design has all of the piezoelectric elements to one side of a vibration node. The end mass near the node is relatively short in length. It is still necessary to accept the pre-compression bolt and to mount the blade possibly with the threads of the bolt extending through the thin end mass. A ½ wavelength transducer would have nominally equal end masses. The piezoelectric elements would be centrally located with an equal number on either side of the displacement node.  
         [0067]    For example, a symmetric ½ wavelength transducer design  1200  is shown in FIG. 14 b - d . Four piezoelectric elements  1210  are centered along the transducer. The piezoelectric material used in this design is PZT-8 available from several piezoelectric suppliers. The center bolt  1220  extends through the piezoelectric elements and is attached to the two end masses  1230 . The end masses  1230  are made from a titanium alloy (Ti6AI4V). The overall length is 1.58 inches, and the diameter is 0.3 inches. The maximum power is estimated to be on the order of about 25 watts.  
         [0068]    In order to achieve higher displacements, ½ wave resonator sections are typically attached to a transducer. These resonators can be designed to supply displacement gain. Therefore, the blade portion is designed as a half wave resonator. Gain is supplied when the diameter of the proximal ¼ wavelength is greater than the distal ¼ wavelength. When the proximal and distal ¼ wavelengths have uniform cross-sections (not necessarily the same cross sections) and the change in the area occurs in the center, then the gain is determined by the ratio of the areas. So for example, if the distal section has half the area of the proximal section then the gain is 2.0. The displacement node is also at the step change. Different features, such as a spatula like end will change the gain and nodal location. But determination of the gain and nodal location for a particular design in the art is well known by those practiced in the art.  
         [0069]    A simple blade  1340  with out a spatula end is shown attached to transducer  1200  in FIG. 14 d . The blade is composed of two cylindrical ¼ wavelength sections. The ratio of the proximal area to the distal area is 2.5, so that the gain is nominally 2.5. Greater gains can be achieved by increasing the area ratio, adding some gain in the transducer section, or with the addition of ½ wavelength to the blade with gain.  
         [0070]    While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.