Abstract:
The present invention is directed to an apparatus for use in internal surgical procedures and is particularly advantageous for use in laparoscopic surgical procedures. An example implementation is directed to a tool having a depth-adjustable cannula having an upper portion that rests on the body, and having an automatically-sealing channel that readily accepts the insertion and removal of surgical instruments without permitting gases to pass. In one particular embodiment, the tool includes a low-profile platform for stabilizing the tool on a body layer, a projection channel with a flexible sleeve for maintaining the channel closed, and an adjustable member for setting the penetration depth of the tool. The flexible sleeve is sufficiently elastic to close the inner channel in response to pressurization between the outside of the flexible sleeve and the inner surface of the hollow channel. The low-profile platform and the adjustable member permit use of the same tool for different body-wall thicknesses.

Description:
RELATED PATENT DOCUMENTS  
       [0001]    This is a continuation application of U.S. patent application Ser. No. 09/246,228, filed on Feb. 8, 1999 (PHIL.110PA), which is related to U.S. patent application entitled, “Choker-Catheter,” Ser. No. 08/988,157, filed on Dec. 12, 1997 (now U.S. Pat. No. 6,004,303), and assigned to the instant assignee and incorporated herein in its entirety, to which priority is claimed. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to an apparatus for use in laparoscopic surgery and, more particularly, to an apparatus for providing a seal or valve structure within a cannula which effectively and cost efficiently prevents inert gas from escaping while allowing the repeated insertion and removal of surgical instruments through the cannula.  
         BACKGROUND OF THE INVENTION  
         [0003]    Recent advancements in surgical techniques and instruments have permitted for incisions of reduced size for a variety of surgical procedures. For example, surgical procedures which only a few years ago required an incision six or seven inches in length are today performed through incisions requiring less than one inch in length. Among other advancements, one type of surgical instrument that has been significant in this regard is the trocar.  
           [0004]    In general, a trocar is a sharply pointed surgical tool that is used to create and maintain small, bowl-like incisions in a body cavity. Surgical instruments, including miniaturized optical devices, can be inserted through these small incisions and manipulated to perform surgical procedures within the body cavity without ever exposing the patient&#39;s internal organs or structures to the outside environment. By enabling the creation and maintenance of small working holes within a patient&#39;s body wall, conventional trocars have greatly contributed to the reduction and size of the incisions required to perform surgical procedures thereby reducing the related complications.  
           [0005]    Conventional trocars generally include an obturator and a cannula. An obturator is a small, nail-like structure for penetrating the body wall to create a working channel into the body cavity. The cannula is a tube-like structure which is inserted into the incision made by the obturator to maintain a working channel even after the obturator is removed. In a typical scenario, the obturator and cannula are assembled into a single unit by inserting the obturator within the cannula, and then a combination is used to puncture the body wall. The obturator can then be carefully withdrawn from the cannula without removing the cannula from the body wall. Surgical instruments can be inserted through this cannula to perform an entire surgical procedure within the body cavity.  
           [0006]    In many surgical procedures involving trocars, the body cavity is inflated with a nontoxic gas before the trocar is employed to create a working pocket or volume within the patient and to prevent the trocar from penetrating internal organs during insertion. In an appendectomy procedure, for example, a patient&#39;s abdomen is inflated with a gas through a veress needle. The obturator is then used to place cannulas in various locations throughout the inflated abdomen to perform the procedure. One such cannula would typically be used to pass a small camera and light into the body cavity so the surgeon could view the operating area within the patient. Other cannulas would be used at other locations to pass surgical instruments into the cavity and remove tissue such as the appendix from the patient.  
           [0007]    Maintaining the patient&#39;s abdomen in an inflated state throughout this procedure is important. To this end, cannulas are often provided with sealing flap valves that are arranged to prevent gas from escaping from the patient&#39;s abdomen after the obturator has been withdrawn. These sealing valves, however, do not prevent gas leakage when the surgical instrument has a diameter that is smaller than the diameter of the cannula seal. Instead gas can easily pass through the gap between the inner walls of the cannula and the outer surface of the surgical instrument to deflate the work area. To prevent such deflation of this type from occurring, physicians often are required to utilize only those instruments whose dimensions closely match those of the cannula. This requirement apparently limits the surgeon&#39;s freedom of choice in selecting surgical instruments for the procedure. Thus, while a surgeon&#39;s instrument might be preferred by a physician, the physician might nonetheless be forced to use a less preferred, and possibly less effective, tool to perform a procedure to avoid deflating a body cavity.  
           [0008]    It is also important for the surgeon to use an assembled obturator and cannula for the particular operation and/or patient. Depending on the body cavity to be explored and the patient undergoing the surgery, the surgical procedures can vary significantly. For example, using an assembled obturator and cannula to puncture the stomach of a baby is quite different than using an assembled obturator and cannula to puncture the stomach of an obese adult. Typically, the procedure for a baby requires that the assembled obturator and cannula be inserted just a short way, enough to pierce a thin stomach wall. Conversely, the same procedure for an obese adult requires that the assembled obturator and cannula be inserted through a relatively thick stomach wall. For such procedures, the conventional obturator and cannula assembly is often too long or too short, thereby making the surgery awkward. For example, when using an obturator and cannula assembly that is too long, the upper end of the assembly extends far above the stomach wall thereby making the assembly unstable.  
           [0009]    Accordingly, there is a need for a surgical instrument and procedure that addresses the above-mentioned, and other, problems in the prior art.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention is directed to an apparatus or tool for use in internal surgical procedures and, more particularly, to a laparoscopic tool for surgical procedures. In a more specific example embodiment, the tool includes a low-profile platform for stabilizing the tool on a body layer, a collapsing sleeve in a projection channel within the tool for maintaining the channel closed, and an adjustable member for setting the penetration depth of the tool.  
           [0011]    In another example embodiment, an apparatus is used for inserting through a body layer and into a body cavity for surgical procedures. The apparatus includes: an elongated tube including an entry port, a channel and an extended portion configured and arranged to extend the entry port above the body layer; and a flexible sleeve located within the hollow channel of the tube and being supported via the elongated tube at first and second locations of the elongated tube, wherein the flexible sleeve is configured and arranged to have slack between the first and second locations such that the sleeve is compressed when under pressure while in use to close the opening.  
           [0012]    In another particular embodiment, a method for accessing through a body layer and into a body cavity for surgical procedures, comprises: providing a tool including an entry port, a channel and an extended portion configured and arranged to extend the entry port above the body layer, and providing a flexible sleeve within the hollow channel; inserting the tool into the body and setting the extended portion on the body layer; placing an instrument within the channel and within the flexible sleeve; permitting the flexible sleeve to conform around the instrument while the instrument is within the channel, and permitting the flexible sleeve to close upon itself while no object is within the channel, such that the flexible sleeve includes sufficient slack between the first and second locations that the sleeve responds as such when under pressure.  
           [0013]    Another example implementation is directed to a tool having a depth-adjustable cannula having an upper portion that rests on the body, and having an automatically-sealing channel that readily accepts the insertion and removal of surgical instruments without permitting gases to pass through a channel in the cannula.  
           [0014]    The above summary of the present invention is not intended to describe each illustrated embodiment of the present invention. Other aspects and embodiments of the invention will become apparent upon a review of the figures and detailed description. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    The invention may be more completely understood in consideration of the detailed description of various embodiments of the invention which follow in connection with the accompanying drawings, in which:  
         [0016]    [0016]FIG. 1A is a perspective view of an example surgical tool, according to the present invention, with a body-piercing portion of the tool removed;  
         [0017]    [0017]FIG. 1B is a perspective view of the body-piercing portion of the example surgical tool of FIG. 1A, according to the present invention;  
         [0018]    [0018]FIG. 1C is a cross-sectional side-end view of the example surgical tool of FIGS. 1A and 1B, according to the present invention, shown in assembled form;  
         [0019]    [0019]FIG. 1D is a perspective view of the example surgical tool of FIGS. 1A and 1B, according to the present invention, shown in assembled form;  
         [0020]    [0020]FIG. 1E is a perspective view of the example surgical tool of FIG. 1A, according to the present invention, shown in unassembled form;  
         [0021]    FIGS.  2 A- 2 F are perspective views of various portions of an example surgical tool manufactured in a manner consistent with the example surgical tool of FIGS. 1A, 1B and  1 C, also according to the present invention;  
         [0022]    [0022]FIG. 3A is a side view of an outer cannula and an inner seal of an example surgical tool according to the present invention;  
         [0023]    [0023]FIG. 3B is an end view according to the present invention of the cannula with its inner seal of the example surgical tool of FIG. 3A; and  
         [0024]    [0024]FIG. 3C is a perspective view showing how a surgical instrument, such as illustrated in FIGS. 3A and 3 b , can be inserted through the cannula and its inner seal while maintaining a closed seal within the cannula, also according to the present invention.  
     
    
       [0025]    While the invention is amenable to other various modifications in alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to a particular embodiment described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.  
       DETAILED DESCRIPTION  
       [0026]    The present invention is applicable to a variety of apparatus and arrangements in which external instruments are to be passed through an opening separating two environments in which a pressure difference between these environments exists and in which maintaining a seal between these environments is beneficial. The invention has been found to be particularly advantageous in laparoscopic surgery where surgical instruments are passed into a body cavity (human or otherwise) to perform an operation. While the present invention is not so necessarily limited, various aspects of the invention can be appreciated through discussion of application examples in such an environment.  
         [0027]    Turning now to the drawings, FIGS.  1 A- 1 E illustrate an example laparoscopic tool  100  that is used to create and maintain a small incision through a body layer, such as a stomach wall, having any of a number of thicknesses. FIG. 1A shows the tool  100  from a side view with the piercing portion of the tool  100  removed. The laparoscopic tool  100  includes a main body  112  including an upper portion  112   a  and an elongated section  112   b  having a hollow center channel, an inner flexible tube  115  for collapsing the channel sealed, and an outer adjustment sleeve  116  adapted to provide a depth-settable scope at the bottom of the tool  100 . The inner flexible tube  115  is open-ended at each end and fits within the channel of the elongated section  112   b . The inner flexible tube  115  has one end secured between a tube lock  132  and the upper portion  112   a , and has another end secured at a location  123  near the end of the elongated section  112   b , for example, using a heat weld, glue or other adhering substance. The inner flexible tube  115  has sufficient slack so that it collapses closed under a pressure in the body cavity, for example, as provided into the body cavity via a gas supply feeding a channel  120 .  
         [0028]    [0028]FIG. 1B shows the piercing portion of the tool  100  of FIG. 1A. This portion of the tool  100  includes a pin  114  secured at an upper end to a pin holder  130 , and a lock  118 . The lock  118  has a lock head  118   a , a pin-receiving channel  118   b , and a separable end  118   c . The separable end  118   c  includes a plurality of sections (e.g.,  3  or  4 ), each having an outwardly-extending protrusion  118   d  that is designed to lock into a corresponding aperture  116   a  within the outer adjustment sleeve  116  of FIG. 1A.  
         [0029]    As shown in the cross-sectional view of FIG. 1C, the piercing portion (FIG. 1B) of the tool  100  is inserted into the inner flexible tube  115  within the channel of the elongated section  112   b . Once assembled, the piercing portion (FIG. 1B) of the tool  100  can be adjusted along the elongated section  112   b  so that the distance between the underside of the upper portion  112   a  and the girth at the bottom of the pin  114  corresponds to the thickness of the body layer being penetrated. With the piercing portion of the tool  100  adjusted for the corresponding body layer thickness, the upper portion  112   a  can rest on the body layer and thereby provide a foundation above the fatty body layer for insertion and control of instruments to be inserted through (into and out of) the inner flexible tube  115 . The entry port, beginning at the upper side of the upper portion  132   a , has a conical shape to aid in guiding instruments into the inner flexible tube  115 .  
         [0030]    The above example embodiment of the present invention is advantageous in that only one laparoscopic tool is needed for a variety of body layer thicknesses. The above embodiment is also advantageous in that the upper portion  112   a  of the main body  112  extends above the body layer. This provides the operator (or surgeon) a wide and elevated base, or platform, over the outer body layer and from which the operator can control the surgical instruments. In one embodiment, the upper portion  112   a  is about ¾ inch high and several inches wide; however, the height and girth of the upper portion  112   a  can vary.  
         [0031]    [0031]FIGS. 1D and 1E respectively illustrate perspective views of the tool  100  of FIG. 1A in assembled and unassembled form.  
         [0032]    Referring now to FIGS.  1 C- 1 D, the pin holder  130  includes a curved surface that mates with a curved surface on the lock head  118   a . When the pin holder  130  is turned relative to the lock head  118   a  so that the two surfaces are in a locked and non-mated position, these curved surfaces provide a cam action to draw the bulb end of the pin  114  part way into the end of the lock  118 . This cam action, in turn, causes the flexible end  118   c  of the lock  118  to lock into the end  116   a  of the sleeve  116 , thereby setting the various parts of the laparoscopic tool  100  so that it can be used to make the desired incision. Once the incision is made, the gas supply can be used to inflate the inner flexible tube  115  and body cavity, and the pin holder  130  can be turned relative to the lock head  118   a  so that the two surfaces are in a mated position. Turning the pin holder  130  in this manner causes the flexible end  118   c  of the lock  118  to be released from its lock into the end  126   a  of the sleeve  116 . The lock head  118   a  is then drawn upward and out of the main body  112  to remove the lock  118  and the pin/pin-holder assembly  114 / 130  from the main body  112 . Surgical instruments are then inserted into the tube lock  132  and the end of the inner flexible tube  115  for viewing and/or surgical manipulations within the inflated cavity.  
         [0033]    Another important aspect of the present invention concerns maintaining that the body cavity is in an inflated state throughout the procedure. To this end, the inner flexible tube  115  is configured and arranged to seal the incision during the surgery, even after the pin  114  is withdrawn and other instruments are inserted and withdrawn. Regardless of the diameters of the instruments, gas cannot easily pass into or out of the body cavity and deflate the work area. In various embodiments, the inner flexible tube  115  is constructed of a slippery polyurethane or Teflon-like material to permit the easy passage of an external instrument through the sleeve to exit the rigid tube  102  at its first end  106 . The slippery, plastic, polyurethane-like material also provides the required elasticity to allow the flexible tube to be compressed under pressure to close the opening of the inner channel formed within the flexible tube.  
         [0034]    When used for laparoscopic surgery, the tool  100  creates a small hole within the body cavity, with the hole sized to match the outer diameter of the outer adjustment sleeve  116 . The body cavity is generally pressurized using an inert gas, such as CO 2 , such that the internal pressure within the body cavity is greater than the outside air. When the outer adjustment sleeve  116  is inserted within the pressurized body cavity, this pressurization enters the outer adjustment sleeve  116  at its lower end and thereby compresses the inner flexible tube  115 . Because the flexible tube  115  is attached at the end of the main body  112 , the flexible tube  115  gathers and compresses, closing the channel along the whole length of the flexible tube  115  and preventing the escape of the pressurized gas from inside the body cavity.  
         [0035]    When in this configuration, a surgical instrument can be inserted through tube lock  132  to enter within the inner channel of the now collapsed inner flexible tube  115 . As the instrument is inserted through the flexible tube, the flexible tube will conform around the external instrument, thus permitting the instrument to pass through the inner flexible tube  115  and exit the rigid main body  112 . At the same time, the pressurization is present within the main body&#39;s upper end. The pressurization continues to press the flexible tube against the surfaces of the external instrument as it passes through the inner channel. The external instrument can now be used to perform surgical procedures within the body cavity.  
         [0036]    As the external instrument is removed, it passes back through the inner channel of the flexible tube. Pressurization from within the body cavity maintains the collapsed structure of the flexible tube, thereby maintaining the seal of the inner channel around the instrument until it is closed when the instrument is completely removed.  
         [0037]    In accordance with one aspect of the present invention, an example surgical procedure includes using the laparoscopic tool  100  in assembled form (FIG. 1B) to puncture an incision through a body wall. This procedure includes setting the outer adjustment sleeve  116  so that it is ratched all the way up along the elongated section  112   b  toward the upper portion  112   a . In one implementation, the outer adjustment sleeve  116  sleeve includes an encircling ridge  116   b  for catching and locking onto the protrusions  112   c  of the elongated section  112   b . The puncture is then performed by pressing the tool  100  into the body until the underside of the upper portion  112   a  resides on the skin or outer body layer. In one example application, the underside of the upper portion  112   a  is adhered to the stomach wall using two-way tape  108 . Next, with the main body  112  held against the skin, the lock  118  is pressed downward. This causes the outer adjustment sleeve  116  to ratchet with the pin further into the body cavity, then to the desired depth. In one application, the position of the outer adjustment sleeve  116  is selected for a desired depth (e.g., up to 3-4½ inches below the main body  112 ), depending on the thickness of the body layer (e.g., body fat) from the outer skin or layer to where the incision reaches the body cavity. Once the incision is complete, the pin  114  and the lock  118  are unlocked and removed to permit a surgical instrument to be inserted into the inflated body area for viewing and manipulation.  
         [0038]    FIGS.  2 A- 2 F show perspective views of example parts used for implementing the surgical tool  100  of FIGS. 1A, 1B and  1 C. In FIG. 2A, the upper portion  112   a  of the main body  112  is shown to include a recess area for receiving and securing therein an end of the flexible tube ( 115  of FIG. 1A) with the tube lock ( 132  of FIG. 2F) over the end of the flexible tube.  
         [0039]    The main body  112  further includes protrusions  112   c  along its extended portion for engaging and locking to an encircling ridge  116   b  on the inner surface of the sleeve  116  (FIG. 2D). According to alternative example embodiments consistent with the present invention, the adjustment mechanism providing this engaging and locking can be implemented using the illustrated ratchet-like ladder along the length of the extended portion of the main body  112 . Alternative locking methods include threads or an elongated tube. By using a nonpermanent securing mechanism such as the illustrated ratchet-like ladder, the outer adjustment sleeve  116  can be advantageously readjusted.  
         [0040]    [0040]FIGS. 2B and 2C illustrate example structures for the pin holder  130  and the pin  114 . The pin holder  130  includes an aperture  130   a  for securing therein the pin  114  of FIG. 2C. The cam-like surface of the pin holder  130  is depicted as  130 b. The pin  114  of FIG. 2C is expanded to show the bulb surface  114 a for engaging and expanding the end  118   c  of the lock  118  (FIG. 2E), the tip  114   b  for incising the body wall, and the shaft  114   c  that enters the port  112   b  of the main body  112  (FIG. 2A).  
         [0041]    The lock  118  of FIG. 2E and the outer adjustment sleeve  116  of FIG. 2D further show one of the interlocking sleeve/lock mechanisms. The lock  118  includes a pliable or flexible end with partially separable members  118   c  that, in response to receiving the bulb portion  114   a  of the pin  114  (FIG. 2C), are forced outwardly to mate protrusions  118   d  into apertures  116   a  of the sleeve  116 .  
         [0042]    These various components of FIGS.  2 A- 2 F can be manufactured in a number of different ways including, for instance, via molded plastics (e.g., propylene).  
         [0043]    Referring now to FIG. 3A, an alternative surgical instrument  301  consists of an elongated rigid tube  302  in which a flexible tube or sleeve  303  is placed within a hollow channel located within the rigid tube  302 . The flexible tube or sleeve  303  is supported on the rigid tube  302  using a weld  305  attaching the bottom of the tube to the side wall. The flexible tube is also supported with some overlap  306  at the point at which the rigid tube  302  mates with an entrance receptacle  304  as it attaches to the upper end of the rigid tube  302 . The receptacle  304  is a funnel shaped device that has a wide opening  308  and a narrow opening  307  for mating with the rigid tube  302 . This funnel structure is useful in guiding the insertion of external instruments into the rigid tube  302  and flexible tube  303  by permitting the funnel structure to guide the instruments towards the center of the rigid and flexible tubes.  
         [0044]    In one embodiment, the flexible tube  303  is constructed of a slippery polyurethane or Teflon-like material to permit the easy passage of an external instrument through the sleeve to exit the rigid tube  302  at its first end  306 . The flexible tube  303  has a slippery, plastic, polyurethane-like material to provide the required elasticity that allows the flexible tube  303  to be compressed under pressure and to close the opening of the inner channel formed within the flexible tube  303 .  
         [0045]    When in use for laparoscopic surgery, the rigid tube  302  is inserted within a small hole within the body cavity. The small hole within the body cavity can be sized to match the outer diameter of the rigid tube  302 . The body cavity is generally pressurized using an inert gas, such as CO 2 , such that the internal pressure within the body cavity is greater than the outside air. As such, when the rigid tube  302  is inserted within the pressurized body cavity, this pressurization enters the rigid tube at its first end  306  compressing the flexible tube  303  upwards. Because the flexible tube is attached using along the weld  305 , the flexible tube gathers and compresses, closing the opening of the inner channel thus preventing the escape of the pressurized gas from inside the body cavity.  
         [0046]    When in this configuration, a surgical instrument can be inserted through receptacle  304 , as it is passed through the opening  308  of receptacle  304  and to enter within the inner channel of the now collapsed flexible tube  303 . As the instrument is inserted through the flexible tube, the flexible tube will conform around the external instrument, thus permitting the instrument to pass through both the flexible tube  303  and exit the rigid tube  302 . At the same time, the pressurization is present within the rigid tube&#39;s first end  306 . The pressurization continues to press the flexible tube against the surfaces of the external instrument as it passes through the inner channel, thus maintaining a within the inner channel. The external instrument can now be used to perform surgical procedures within the body cavity.  
         [0047]    As the external instrument is removed, it passes back through the inner channel of the flexible tube. Pressurization from within the body cavity maintains the collapsed structure of the flexible tube, thus maintaining the seal of the inner channel around the instrument until it is closed when the instrument is completely removed.  
         [0048]    Referring to FIG. 3B, an end view of the surgical instrument looking down towards the top of the receptacle is shown. The outer edge  308  shows the outer dimension of the receptacle which funnels down towards the mating surface between the receptacle and the rigid tube  302 . The flexible tube  303  is depicted in its closed position as the flexible tube  303  is gathered up to close the opening within the inner channel formed within  307 . While an external instrument is inserted down through the center of the structure, the flexible tube  303  conforms to the shape and surface of the external instrument.  
         [0049]    Referring to FIG. 3C, an embodiment of the present invention is shown in use where a cannula structure  302  is inserted within a body cavity  301  at an incision  310 . A surgical instrument  330  is passed through the center of cannula  302  through the inner channel of the flexible tube (not shown in FIG. 3C) that seals the opening through the cannula structure  302 . In this particular embodiment, an additional channel structure  334  has been added which permits the supply of an inert gas to be placed within the body cavity  301 . This structure  334  can be an inert gas line that comes from an external source connected to a valve structure  345  and that allows the gas supply to be turned on and off. In one example embodiment, this valve structure  345  is made part of the receptacle housing. This structure  334  is also connected to a secondary tube that runs parallel to the rigid tube  302  of the cannula with an opening near at the first end of the rigid tube  302  permitting the gas to enter within the body cavity  301  on the far end side of the flexible tube  303 , providing the pressurization within the body cavity needed to close the inner channel of the flexible tube  303 . This supply of gas can be made part of the canal as described herein or can be made as a separate structure inserted in the body at some other location.  
         [0050]    The gas supply, as described and illustrated in connection with FIGS.  3 A- 3 C, can be similarly implemented in connection with the structure shown in FIGS.  1 A- 1 C, with a channel for the gas running inside or outside the tools main wall.  
         [0051]    The above specification, examples and data provide a complete description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.