Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a Continuation Application claiming the benefit of and priority to U.S. application Ser. No. 10/943,132, filed on Sep. 16, 2004, which in turn claims the benefit of and priority to U.S. Provisional Application Ser. No. 60/504,506, filed on Sep. 19, 2003, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to surgical apparatus for facilitating the insertion of surgical instruments into a body cavity of a patient and, more particularly, to surgical apparatus adapted to facilitate the insertion of an expansion assembly (i.e., a trocar) through a radially expandable dilation assembly and into the body cavity of the patient. 
         [0004]    2. Background of Related Art 
         [0005]    Minimally invasive surgical procedures are performed throughout the body and generally rely on obtaining percutaneous access to an internal surgical site using small diameter tubes (typically 5 to 12 mm), usually referred to as cannulas, which provide access through the skin of the patient and open adjacent the desired surgical site. A viewing scope is introduced through one such cannula, and the surgeon operates using instruments introduced through other appropriately positioned cannulas while viewing the operative site on a video monitor connected to the viewing scope. The surgeon is thus able to perform a wide variety of surgical procedures requiring only a few 5 to 12 mm punctures through the patient&#39;s skin, tissue, etc. adjacent the surgical site. 
         [0006]    Certain minimally invasive surgical procedures are often named based on the type of viewing scope used to view the area of the body which is the operative site. For example, laparoscopic procedures use a laparoscope to view the operative site and are performed in the interior of the abdomen through a small incision. Such laparoscopic procedures typically require that a gas, such as carbon dioxide, be introduced into the abdominal cavity. This establishes pneumoperitoneum wherein the peritoneal cavity is sufficiently inflated for the insertion of trocars into the abdomen. 
         [0007]    Pneumoperitoneum is established through the use of a special insufflation needle, called a Veress needle, which has a spring-loaded obturator that advances over the sharp tip of the needle as soon as the needle enters the abdominal cavity. This needle is inserted through the fascia and through the peritoneum. Generally, the surgeon relies on tactile senses to determine the proper placement of the needle by recognizing when the needle is inserted through the fascia and then through the peritoneum. After establishing pneumoperitoneum, the next step in laparoscopic surgery involves the insertion of a trocar, obturator or trocar/obturator assembly into the abdominal cavity. 
         [0008]    Preferably, the cannulas used in laparoscopic procedures should be readily sealable to inhibit the leakage of the insufflation gas from the abdominal cavity, in particular, should be designed to inhibit leakage from the region between the external periphery of the trocar and the abdominal wall. 
         [0009]    In order to reduce the amount of insufflation gas which escapes from the abdominal cavity, a radially expandable access system has been developed to provide improved sealing about the periphery of the cannula. A system for performing such a function is commercially available from United States Surgical, a division of Tyco Healthcare, Ltd. under the trademark VERSAPORT™. Certain aspects of the expandable access system are described in commonly assigned U.S. Pat. Nos. 5,431,676; 5,814,058; 5,827,319; 6,080,174; 6,245,052 and 6,325,812, the entire contents of which are expressly incorporated herein by reference. 
         [0010]    As disclosed therein, the expandable access system includes a sleeve having a sleeve body, typically made up of a radially expandable braid covered by an elastomeric layer. The braid initially has an inner diameter of about 2 mm and an outer diameter of about 3.5 mm. In use, passage of a surgical instrument (i.e., trocar, cannula, obturator, etc.) through the expandable access system causes radial expansion of the sleeve, typically to a final diameter of 5 mm, 10 mm or 12 mm. However, the sleeve can be expanded to any necessary diameter in order to accommodate the particular surgical instrument. The expandable access system further includes a handle affixed to a proximal end of the sleeve, the handle including a passage formed therein for the introduction of surgical instruments, through the handle, into the sleeve body. 
         [0011]    A method of use of the expandable sealing apparatus includes inserting a pneumoperitoneum needle through the radially expandable sleeve body of the expandable access system to thereby form a needle/sleeve assembly. The needle/sleeve assembly is then introduced through the patient&#39;s abdomen by engaging the sharpened distal end of the pneumoperitoneum needle, protruding from the distal end of the sleeve body, against the body tissue of the body cavity and advancing the needle/sleeve assembly into the body cavity until the needle/sleeve assembly extends across the layers of the body tissue thereby forming an incision in the body tissue. The pneumoperitoneum needle is then removed from the body of the sleeve. A cannula, having a diameter smaller than the opening in the handle and larger than the lumen of the sleeve, is then introduced through the opening in the handle and into the abdomen of the patient. As a result, due to radial expansion of the sleeve by the trocar, the incision is subsequently also radially expanded. Cannulas used in laparoscopic procedures include a valve at a proximal end thereof in order to permit passage of a trocar, viewing scope or other surgical instrument therethrough while simultaneously inhibiting escape of insufflation gas from the abdominal cavity. 
         [0012]    Accordingly, there exists a need for an expansion assembly insertion apparatus which facilitates and enhances control of the insertion of and expansion assembly into the axial lumen of a radially expandable dilation assembly and into the abdominal cavity of the patient. 
       SUMMARY 
       [0013]    Apparatus for forming and enlarging a percutaneous penetration are disclosed. According to one aspect of the present disclosure, the apparatus includes an elongate dilation member including a radially expandable member having a proximal end with a handle, a distal end, and an axial lumen with a first cross-sectional area; and an elongate expansion member including a tubular element having a distal end, a proximal end with a handle, and an axial lumen with a second cross-sectional area which is larger than the first cross-sectional area. The distal end of the expansion member is configured for facilitating insertion of the tubular element through the axial lumen of the dilation member. The apparatus further includes an advancing apparatus having a first arm with a first engaging feature for engaging the handle of the dilation member; a second arm with a second engaging feature for engaging the handle of the expansion member; and an operation member. The first arm and the second arm are connected so that operation of the operation member approximates the first engaging feature and the second engaging feature together. 
         [0014]    It is envisioned that the radially expandable member includes a braided sleeve. It is further envisioned that the radially expandable member includes a splittable sheath. 
         [0015]    Desirably, the operation member is attached to the second arm. The second arm may include a passage for receiving the first arm. The operation member may be pivotally attached to the second arm and may have a pivotal link engaging the first arm so that upon pressing the operation member, the link moves the first arm proximally. 
         [0016]    Desirably, the first arm extends parallel to the longitudinal axes of the dilation member and the expansion member. It is contemplated that the first arm and the second arm may include inter-engaging ratchet teeth. It is further contemplated that the first arm and the second arm may be pivotally attached so that pressing the operation member toward the first arm approximates the first engaging feature and second engaging feature together. 
         [0017]    According to another aspect of the present disclosure, an apparatus for facilitating the insertion of an expansion assembly distally through a radially expandable dilation assembly into a body cavity of a patient is provided. The apparatus includes a handle; and a trigger operatively coupled to the handle. The trigger is pivotable between a first position, spaced a distance from the handle, and a second position, in close proximity to the handle. The apparatus further includes a spine member having a proximal end and a distal end. The spine member is slidably received within the handle and is axially moveable relative to the handle upon a manipulation of the trigger from the open position to the closed position. 
         [0018]    The apparatus further includes an actuation mechanism in operative engagement with the handle, the trigger and the spine member. The actuation mechanism is releasably engagable with the spine member and, when engaged with the spine member, axially moves the spine member relative to the handle upon movement of the trigger to the closed position. The apparatus further includes an expansion assembly retaining structure operatively coupled to the handle for holding the expansion assembly in place; and a yoke provided at the distal end of the spine member for maintaining the dilation assembly aligned with the expansion assembly. 
         [0019]    Desirably, manipulation of the trigger towards the handle incrementally approximates the yoke toward the expansion assembly retaining structure. 
         [0020]    It is envisioned that the yoke defines a distal clevis and a proximal clevis. Accordingly, tabs extending from opposite sides of a handle of the dilation assembly are positionable between the distal clevis and the proximal clevis. It is further envisioned that the expansion assembly retaining structure includes at least one C-shaped cuff configured to operatively engage a handle of the expansion assembly in a snap-fit manner. 
         [0021]    The actuation mechanism may include a driving lever operatively supported on the spine member; a linkage member having a first end pivotally connected to the trigger and a second end slidably received within the handle and pivotally connected to the driving lever; and a compression spring disposed between the driving lever and an inner surface of the handle. The compression spring desirably biases the driving lever to an orientation orthogonal to the spine member. Accordingly, actuation of the trigger toward the handle causes the driving lever to pivot and bind against the spine member. 
         [0022]    The actuation mechanism may further include a braking lever operatively supported on the spine member, a first end of braking lever is pivotally positioned within a recess formed in the handle; and a spring member disposed between braking lever and a surface formed in the handle, wherein the spring member biases a free end of the braking lever in a distal direction. 
         [0023]    It is envisioned that the proximal end of the spine member may extend from a proximal end of the handle. 
         [0024]    The apparatus may include an elongate dilation assembly operatively associatable with the yoke. The elongate dilation assembly may include a handle, a radially expandable tubular sheath having a proximal end connected to the handle, a distal end, and defining an axial lumen with a first cross-sectional area. The apparatus may further include an elongate expansion assembly operatively connectable to the at least one cuff. The expansion assembly may include a tubular element having a distal end, a proximal end with a handle, and an axial lumen with a second cross-sectional area which is larger than the first cross-sectional area of the elongate dilation assembly. 
         [0025]    According to another aspect of the present disclosure, a kit for providing access to a target surgical site is provided. The kit includes a radially expandable dilation assembly; a pneumoperitoneum needle assembly; a stylet; an expansion assembly; an obturator; an expansion assembly insertion apparatus for forming and enlarging a percutaneous penetration; and a package for enclosing the radially expandable dilation assembly, the pneumoperitoneum needle assembly, the stylet, the expansion assembly, the obturator, and the expansion assembly insertion apparatus. 
         [0026]    The kit may further include a package insert including at least one of instructions on use and warnings of use. 
         [0027]    Other features and advantages of the disclosed trocar insertion apparatus will appear from the following description in which the preferred embodiment has been set forth in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure. 
           [0029]      FIG. 1  is a side elevational view of a radially expandable dilation assembly for sealing a percutaneous opening in a patient; 
           [0030]      FIG. 2  is a side elevational view of a pneumoperitoneum needle component of the dilation assembly, shown with a stylet removed from a tubular needle body; 
           [0031]      FIG. 3  is a partly separated side elevational view of a cannula assembly of an elongate expansion assembly; 
           [0032]      FIG. 4  is a side elevational view of an obturator component for use with the elongate expansion assembly of  FIG. 3 ; 
           [0033]      FIG. 5  is a perspective view of an expansion assembly insertion apparatus, in accordance with the present disclosure, having an expansion assembly and a dilation assembly operatively mounted thereto; 
           [0034]      FIG. 6  is a cross-sectional side elevational view of the fixed handle and trigger of the expansion assembly insertion apparatus, taken along the longitudinal axis thereof, illustrating an exemplary actuation mechanism; 
           [0035]      FIGS. 7-10  illustrate use of the expansion assembly insertion apparatus in connection with the dilation assembly of  FIG. 1  and the expansion assembly of  FIG. 2  for facilitating insertion of the expansion assembly in to the dilation assembly; and 
           [0036]      FIG. 11  illustrates a kit including a radially expandable dilation assembly, a pneumoperitoneum needle, a cannula assembly, an obturator and an insertion apparatus present in a package. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0037]    Preferred embodiments of the presently disclosed expansion assembly insertion apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal”, as is traditional will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator, while the term “distal” will refer to the end of the device or instrument which is furthest from the operator. 
         [0038]    Referring now in detail to the drawing figures, as seen in  FIG. 1 , a radially expandable dilation assembly is generally designated with the reference numeral  10 . Radially expandable dilation assembly  10  includes a tubular sheath  12  having a proximal end  14 , a distal end  16  and an axial lumen  15  extending therethrough. Axial lumen  15  defines a longitudinal axis “X” and further defines a first cross-sectional area extending therethrough. Proximal end  14  is tapered radially outward in the proximal direction and is secured to a handle  18 . Handle  18  includes an aperture  20  extending therethrough and interconnected with lumen  15  of tubular sheath  12 . Tubular sheath  12  may be made from any material which is capable of receiving an expansion assembly to effect radial expansion of sheath  12 , as described in more detail hereinafter. 
         [0039]    Sheath  12  preferably includes an inelastic braid covered by an elastic membrane, as described in commonly assigned U.S. Pat. No. 5,431,676, the full disclosure of which is incorporated herein by reference. Suitable expandable sleeves  10  may be obtained commercially from United States Surgical, a division of Tyco Healthcare, Ltd., as part of the STEP™ introducer system. 
         [0040]    A pneumoperitoneum needle assembly  30  including a tubular needle  32  and a stylet  34  is illustrated in  FIG. 2 . Tubular needle  32  includes a hub  36  having a male bayonet connector  38  at a proximal end thereof. Preferably, stylet  34  is spring loaded in a proximal connector  40  which includes a male bayonet fitting  42 . Male bayonet fitting  42  is receivably coupled to female bayonet fitting (not illustrated) of hub  36 . An insufflation valve  44  is connected to the proximal end of stylet  34  and a port  46  is formed in a distal end thereof. Port  46  permits the introduction of insufflation gas through valve  44  to be released through stylet  34 . In use, stylet  34  is mounted within needle  32  with bayonet fitting  42  attached to hub  36 . The distal end of stylet  34  in turn extends from a distal end  48  of needle  32  such that stylet  34  will retract into needle  32  when needle assembly  30  is engaged against tissue, as described in more detail below. 
         [0041]    Referring now to  FIG. 3 , an expansion assembly  50  is shown and described. Expansion assembly  50  includes an expansion member  52  (i.e., a cannula tube) and a proximal hub  54 . Expansion member  52  includes a threaded connector  56  at its proximal end which can be removably secured to a fitting  58  in the distal end of proximal hub  54 . Preferably, expansion member  52  defines a second cross-sectional area which is larger than the first cross-sectional area of tubular sheath  12 . 
         [0042]    With reference to  FIG. 4 , an obturator  70  including a shaft  72  having a tapered distal end  74  and a handle  76  is shown and described. As will be described in greater detail below, obturator  70  is intended to be placed within a central lumen of cannula assembly  50  in order to facilitate insertion of expansion assembly  50  into radially expandable dilation assembly  10 . 
         [0043]    Turning now to  FIG. 5 , an expansion assembly insertion apparatus in accordance with the present disclosure, having an expansion assembly  50  and a dilation assembly  10  operatively mounted thereto, is shown generally as reference numeral  100 . Insertion apparatus  100  includes a proximally extending fixed handle  102 , a trigger  104  pivotably coupled to fixed handle  104  at pivot pin  118 , and a distally extending spine member  106 . Spine member  106  has a distal end  108  and a proximal end  110  defining a longitudinal axis “X′”. Proximal end  110  of spine member  106  is slidably received within fixed handle  102  through an aperture  102   a  formed in a distal end of fixed handle  102 . While a generally rectangular cross-section for spine member  106  has been depicted it is contemplated that spine member  106  can have a circular, elliptical, square or other polygonal cross-section. 
         [0044]    Distal end  108  of spine member  106  is provided with a yoke or engaging feature  112  operatively coupled thereto. Yoke  112  defines a U-shaped clevis  114  having a pair of legs  116 ,  117 . Preferably, clevis  114  includes a distal pair of legs  116   a ,  117   a  and a proximal pair of legs  116   b ,  117   b . Legs  116 ,  117  define an axis which is substantially parallel to the longitudinal “X′” axis of spine member  106 . In use, U-shaped clevis  114  of yoke  112  receives handle  18  of dilation assembly  10  therein. In particular, handle  18  includes a pair of diametrically opposed tabs  18   a ,  18   b  wherein either tab  18   a  or  18   b  is positioned between distal and proximal legs  116   a  and  116   b  while the other of tab  18   a  or  18   b  is positioned between distal and proximal legs  117   a  and  117   b.    
         [0045]    As best seen in  FIG. 6 , fixed handle  102  includes an actuation mechanism for the mechanical operation of insertion apparatus  100 . The actuation mechanism includes a linkage member  120  having a first end  120   a  which is pivotably coupled to trigger  104  at a pivot point  122  and a second end  120   b  which is slidably received within fixed handle  102  and pivotably coupled to a driving lever  130 . 
         [0046]    Driving lever  130  is located and/or suspended on spine member  106  which passes through an aperture or opening  132  formed in driving lever  130 . A compression spring  134  disposed between driving lever  130  and an inner surface of fixed handle  102  urges driving lever  130  in a distal direction and to remain orthogonal relative to spine member  106 . The force of spring  134  urges trigger  104  against a backing member  126 , via linkage member  120 , of fixed handle  102  thus providing a standby condition. In the standby condition, driving lever  130  is positioned substantially perpendicular to the direction of motion, indicated by the arrow “P”, of spine member  106  when in operation. Motion of trigger  104  about the pivot pin  118  causes spine member  106  to move against the bias of spring  134 , as will be described in greater detail below. 
         [0047]    The actuation mechanism further includes a braking lever  136  having an opening  138  through which spine member  106  passes. One end  140  of braking lever  136  is pivotably positioned in a recess  142  formed in fixed handle  102  such that braking lever  136  may pivot within constraints defined by the surfaces of recess  142  and by the binding of braking lever  136  with spine member  106  when the edges of opening  138  in braking lever  136  engage the surfaces of spine member  106 . At least one compression spring  144  is disposed between a wall  146  in fixed handle  102  and braking lever  136 . Spring  144  effectively biases the free end of braking lever  136  distally away from driving lever  130 . The biased position of braking lever  136  is limited by the binding and/or cocking interference between opening  138  of braking lever  136  and the surfaces of spine member  106 . In the embodiment illustrated in  FIG. 6 , braking lever  136  extends in the direction of fixed handle  102  so that its distal end  148  can be suitably gripped by the thumb of a user. 
         [0048]    It should be noted that in the standby position illustrated in  FIG. 6 , driving lever  130  is substantially perpendicular to the longitudinal “X′” axis of spine member  106 , whereas the portion of braking lever  136  which engages spine member  106  is transversely oriented to the longitudinal “X′” of spine member  106  at a slight angle. In this condition, if a force is applied to yoke  112  ( FIG. 5 ) in the direction indicated by arrow “P”, slide member  106  is free to move through fixed handle  102 . Since braking lever  136  is free to pivot against the bias of spring  144  when force is applied on yoke  112 , in the direction of arrow “P”, braking lever  136  presents no obstacle to the motion of spine member  106  and yoke  112  and thus may be advanced continuously through fixed handle  102 . 
         [0049]    However, in the standby position, as illustrated in  FIG. 6 , if a force is applied to yoke  112  in the direction opposite to the direction indicated by arrow “P”, the edges of opening  138  in braking lever  136  bind against the surfaces of spine member  106  and it is not possible to withdraw the moving yoke  112  further away from fixed handle  102 . Compression of spring  144 , by pressing on braking lever  136  with a finger in the direction of the arrow “P”, allows withdrawal of spine member  106  and yoke  112  to be extended away from fixed handle  102 . Compression of spring  144  brings distal end  148  of braking lever  136  into perpendicularity with the direction of intended motion of spine member  106 , and thus spine member  106  is then free to slide in either direction through opening  136  in braking lever  136 . 
         [0050]    The preferred method of use of expansion assembly insertion apparatus  100  is to squeeze trigger  104  (toward fixed handle  102 ) to incrementally advance spine member  106  and yoke  112  through fixed handle  102 . When trigger  104  is squeezed, pivoting occurs about pivot pin  118  and second end  120   b  of linkage member  120  also moves substantially in the direction of arrow “P”. This causes driving lever  130  to pivot about its first end  131  so that driving lever  130  is no longer perpendicular to the direction “P” of intended motion of spine member  106 . Pivoting of driving lever  130  compresses spring  134  and also causes the end edges of aperture  132 , formed in driving lever  130  to bind against the surfaces of spine member  106 . Binding occurs because driving lever  130  is no longer perpendicular to the direction “P” of intended motion of spine member  106 . Further motion of trigger  104  causes driving lever  130  to translate in the direction of arrow “P”. This motion further compresses spring  134  and in the process, by means of the binding and/or cocking interference between driving lever  130  and spine member  106 , advances spine member  106  and its connected yoke  112  through fixed handle  102 . The maximum distance of advancement of yoke  112 , with one squeeze of trigger  104 , is limited to when spring  134  is fully compressed or trigger  104  strikes the surface of fixed handle  102 . 
         [0051]    After trigger  104  is fully pivoted about pivot pin  118 , release of trigger  104  causes the return of trigger  104  to the stand by condition due to spring  134  urging driving lever  130  to a perpendicular position and pressing linkage member  120  into trigger  104 . 
         [0052]    Returning to  FIG. 5 , fixed handle  102  is further provided with at least one, preferably a pair of resilient C-shaped cuffs  124  affixed to a distal end thereof. Cuffs  124  define a longitudinal axis which is substantially aligned with the axis of clevis  114  defined by legs  116 ,  117 . In use, cuffs  124  are configured to receive proximal hub  54  of cannula assembly  50  therein by a snap-fit type engagement. 
         [0053]    In addition, fixed handle  102  is provided with a backing member  126  as described above. Backing member  126  preferably extends transversely from fixed handle  102  beyond the longitudinal axis of cuffs  124 . Accordingly, in operation, backing member  126  preferably acts as a stop for a proximal end surface of expansion assembly  50  when expansion assembly  50  is mounted to expansion assembly insertion apparatus  100 . 
         [0054]    While insertion apparatus  100  has been shown and described herein as including a trigger  104  for incrementally approximating clevis  114  toward cuffs  124 , it is envisioned and within the scope of the present disclosure that any operation member may be used to accomplish that same function. For example, the operation member may include a ratchet mechanism, a screw drive, a pneumatic drive or the like to advance clevis  114  toward cuffs  124 . 
         [0055]    Referring now to  FIGS. 7-10 , a preferred method of operation of expansion assembly insertion apparatus  100 , will be described. Initially, as seen in FIG. radially expandable dilation assembly  10 , having pneumoperitoneum needle assembly  30  inserted therein, is introduced through a patient&#39;s abdomen “A” (or other body location) by engaging sharpened distal end  48  of needle assembly  30  against the tissue of the patient&#39;s abdomen “A” and advancing the sleeve/needle combination forward until tubular sheath  12  of dilation assembly  10  extends across the tissue of abdomen “A”. 
         [0056]    Needle assembly  30  is then removed, and an expansion assembly  50  including an obturator  70  disposed therewithin is introduced through tubular sheath  12  of dilation assembly  10 , with the aid of expansion assembly insertion apparatus  100  thereby resulting in radial expansion of tubular sheath  12  (see  FIG. 9 ). In particular, yoke  112  of insertion apparatus  100  is preferably first hooked onto handle  18  of dilation assembly  10  as described above. Next, expansion assembly  50 , including obturator  70 , is loaded into insertion apparatus  100  by coupling proximal hub  54  of expansion assembly  50  to cuffs  124  as described above. Finally, insertion apparatus  100  is actuated by repeatedly squeezing trigger  104 , as described above, in order to incrementally advance expansion assembly  50  and obturator  70  through dilation assembly  10 . As expansion assembly  50  and obturator  70  are moved distally through tubular sheath  12 , dilation assembly  10  is radially expanded from the first cross-sectional area to the second cross-sectional area. 
         [0057]    Finally, as illustrated in  FIG. 10 , obturator  70  is removed from expansion member  52 , leaving an access channel through abdominal wall “A” for the introduction of a variety of other surgical instruments through the access channel. 
         [0058]    An ergonomic feature of insertion apparatus  100  is the substantially longitudinally oriented fixed handle  102  and trigger  104 . In other words, fixed handle  102  is preferably aligned with the longitudinal axis of spine member  106  while trigger  104  is preferably pivotable to a closed position which is substantially aligned with the longitudinal axis of spine member  106 . Thus, the longitudinal axis of insertion apparatus  100  is oriented in a substantially orthogonal direction with respect to the longitudinal axis of the forearm of the surgeon. Accordingly, the application of the insertion force by the surgeon preferably occurs by the surgeon gripping fixed handle  102  and trigger  104  and pivoting his forearm about his elbow such that is hand travels in a direction substantially co-linear with the longitudinal axis of insertion apparatus  100 . 
         [0059]    Turning now to  FIG. 11 , an exemplary package or “kit” containing various combinations of system components is illustrated. Providing such kits is a particularly convenient way to facilitate inventory maintenance of the components necessary to reconstruct the access systems of the present disclosure. It will be appreciated, of course, that complete systems could be sold in kits, as well as each of the individual components can be sold in their own kits. In many cases, it will be desirable to combine the pairs of components or multiple pieces of a single component together in one package, particularly where the components are sized to match each other. The kits will include conventional package elements, typically pouches, envelopes, trays, boxes, foam inserts and other containers of a type commonly used for sterile or non-sterile packaging of surgical instruments. The packages will typically also include a “package insert P” which is a written instruction sheet with instructions on use, warnings, etc. 
         [0060]    As seen in  FIG. 11 , an exemplary kit  200 , for providing access to a target surgical site, includes a package  202 , typically non-sterile since the reusable components can be subsequently sterilized and at least one of the following items: a radially expandable dilation assembly  10 ; a pneumoperitoneum needle assembly  30 ; a stylet  34 ; an expansion assembly  50 ; and an obturator  70 . Kit  200  further includes an expansion assembly insertion apparatus  100 . 
         [0061]    Although the foregoing disclosure has been described in some detail by way of illustration and example, for purposes of clarity or understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Technology Category: 1