A surgical instrument for percutaneous accessing body tissue including a tissue piercing element for creating an opening through a body wall. The surgical instrument may include a working member for performing a surgical procedure within the body. Alternatively, the surgical instrument may include an introducer having a stabilizing structure for facilitating the passage of the tissue piercing element and for releasably affixing the surgical instrument to the body tissue surface, thereby securing the surgical instrument relative to the patient's body.

BACKGROUND 
1. Technical Field 
This disclosure relates to a surgical instrument and, more particularly, to 
a surgical instrument for percutaneously accessing an operative site 
within a body. 
2. Background of Related Art 
Accessing body tissue within a body cavity or beneath the skin involves 
creating an opening in the skin through which different types of surgical 
instruments are inserted to perform various surgical or diagnostic 
functions. The opening of the skin to access an operative site is usually 
created by incising with a surgical knife or by puncturing through the 
skin with an instrument having a sharp tip such as a needle or an 
obturator. Additional instruments are then inserted through the incision 
to perform the surgical procedure. For example, the surgeon may use one 
instrument for piercing the skin to introduce a pressurized gas to inflate 
or distend the surgical site, an endoscope for viewing areas or objects 
surrounding the surgical site and other instruments for performing 
surgical functions such as shearing and stapling. Therefore, frequent 
insertions and withdrawals of surgical instruments through the skin 
opening are typical. These insertions and withdrawals through the skin 
opening may traumatize the body tissue surface layer which surrounds the 
skin opening, enlarge the incision or opening, and/or create room for 
undesired or inadvertent movement of the surgical instrument during the 
surgical procedure. 
A trocar is one commonly used surgical instrument for creating a port of 
entry through the skin. A trocar guide sleeve is thus positioned for 
receiving surgical instruments and for facilitating passage of the 
surgical instruments through the skin opening. However, unless the trocar 
guide sleeve is somehow affixed in a stationary position with respect to 
the body, the frequent insertion and withdrawal of surgical instruments 
may move the sleeve, causing enlargement of the incision and/or trauma to 
the surrounding tissues. Moreover, whether or not a sleeve is fixed or 
held stationary relative to the body, manipulative movement of the 
surgical instrument while it is received in the sleeve may be inhibited. 
A variety of percutaneous instruments for providing communication through 
the surface of body tissue are known. Known percutaneous instruments 
typically include a cutting or puncturing implement and some sort of 
safety mechanism, e.g., a spring-biased blunt styler or shielding tube 
which is biased to protrude beyond the distal end of the cutting implement 
to obstruct anatomical organs from making cutting contact with the cutting 
implement. Examples of devices which include spring-biased safety 
mechanisms and provide for percutaneous introduction include conventional 
Verres needles and the devices shown in U.S. Pat. No. 4,535,773 to Yoon; 
U.S. Pat. No. 4,556,059 to Adamson, Jr.; U.S. Pat. No. 4,601,710 to Moll; 
and U.S. Pat. No. 5,152,754 to Plyley et al. 
Various trocars and devices for securing other surgical devices relative to 
a patient's body have also been proposed. See for example, U.S. Pat. No. 
2,898,917 to Wallace, U.S. Pat. No. 3,487,837 to Petersen, U.S. Pat. No. 
4,170,995 to Levine et al. and U.S. Pat. No. 4,915,694 to Yamamoto et al. 
Devices for supporting surgical instruments larger than catheters have 
also been proposed. For example, U.S. Pat. No. 5,073,169 to Raiken 
discloses a trocar support having an elastic membrane having an aperture 
to receive the trocar. The elastic membrane has a flat base for adhering 
to the patient's skin. 
Notwithstanding the devices discussed above, a need remains for an 
instrument which minimizes the passage of surgical instruments through the 
skin opening, thereby minimizing potential enlargement of and trauma to 
the incision site. The surgical instrument disclosed herein provides such 
advantageous features. 
SUMMARY 
A surgical instrument is provided for percutaneously accessing an operative 
site within a body and for performing a surgical procedure within the 
body. The surgical instrument includes a frame having first and second 
ends, and a tissue piercing assembly having an elongated tubular portion 
forming a tissue piercing portion at a distal end. The elongated tubular 
portion defines a longitudinal axis. A tool assembly is disposed at least 
partially within the elongated tubular portion and has at least one 
working member. The surgical instrument further includes an actuating 
mechanism operatively associated with the frame and the tool assembly. The 
actuating mechanism manipulates the at least one working member in 
connection with the surgical procedure. 
In another embodiment, the surgical instrument includes a control assembly 
disposed adjacent the second end of the frame and operatively associated 
with the tissue piercing assembly. The control assembly controls 
longitudinal movement of the tissue piercing assembly and is configured to 
move the elongated tubular portion between a first position wherein the at 
least one working member is recessed within the elongated tubular portion 
and a second position wherein the at least one working member extends 
distally out from the distal end of the tissue piercing assembly. When in 
the first position, the tubular portion prevents manipulation of the at 
least one working member. The control assembly includes structure which 
maintains the elongated tubular portion in the second position. When in 
the second position, an operator may engage skin with the tissue piercing 
portion of the elongated tubular portion. 
The control assembly automatically retracts the elongated tubular portion 
to a retracted position proximal that of the at least one working member 
upon piercing of the skin by the tissue piercing portion. The actuating 
mechanism includes a movable handle pivotally connected at a first end to 
the frame, and at least one linking member having a first end operatively 
associated with the tool assembly and a second end operatively associated 
with the first end of the movable handle. Movement of the movable handle 
moves the at least one linking member to manipulate the at least one 
working member. 
In another embodiment of the surgical instrument, a novel introducer is 
included for accessing an interior portion of a patient's body. The 
introducer is adapted to be affixed relative to the access opening and 
facilitates the passage of at least a portion of the tissue piercing 
assembly therethrough. The introducer, however, is not limited to use only 
with the surgical instrument embodiments described herein; rather, it is 
envisioned that one skilled in the art could find use of the introducer 
with other surgical instruments. Optionally, one portion of the introducer 
may function as a trocar. That portion is inserted and disposed in the 
opening for guiding a surgical instrument. Another portion of the 
introducer is affixed to the body tissue surface thereby securing the 
inserted surgical instrument relative to the body of a patient. 
Briefly, the introducer includes: a stabilizing structure defining a 
longitudinal axis and having a longitudinally extending bore therethrough 
for receiving a surgical instrument, a flexible tissue anchoring skirt 
positioned adjacent a distal end portion of the stabilizing structure, the 
skirt having an opening therein in communication with and concentric to 
the longitudinal bore of the stabilizing structure and a tissue engaging 
surface for releasably affixing the introducer to a body tissue surface; 
and an accessing element extending distally from the flexible tissue 
anchoring skirt, the accessing element having a longitudinal bore 
therethrough, the longitudinal bore of the accessing element being in 
concentric alignment and communication with the skirt opening and the 
stabilizing structure bore. The accessing element typically has a distally 
tapering distal end portion for accessing body tissue. 
The tissue piercing assembly is adapted for insertion through the 
stabilizing structure to puncture body tissue. Alternatively, prior to 
insertion of the tissue piercing assembly, an obturator having a sharp tip 
may be inserted through the stabilizing structure and the accessing 
element to initially puncture the body tissue and thereby facilitate 
insertion of the tissue piercing assembly. 
Another embodiment of the introducer includes stabilizing structure having 
a collar defining a longitudinal axis and having a longitudinally 
extending bore therethrough for receiving a surgical instrument, a 
flexible tissue anchoring skirt positioned adjacent a distal end portion 
of the stabilizing structure, the skirt having an opening therein in 
communication with and concentric to the longitudinal bore of the collar 
and a tissue engaging surface for releasably affixing the surgical 
instrument to a body tissue surface; and an accessing element extending 
distally from the flexible tissue anchoring skirt, the accessing element 
having a longitudinal bore therethrough, the longitudinal bore of the 
accessing element being in concentric alignment and communication with the 
skirt opening and the collar bore. The accessing element typically has a 
distally tapering stub having a distal end tip for accessing body tissue. 
Advantageously, the introducer described hereinabove eliminates the need 
for a separate obturator for creating an opening in the body tissue.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
In the drawings and in the description which follows, the term "proximal", 
as is traditional, will refer to the end of the surgical instrument which 
is closest to the operator, while the term "distal" will refer to the end 
which is furthest from the operator. 
Referring now to the drawings wherein like reference numerals indicate 
similar structural elements of the subject disclosure, there is 
illustrated in FIG. 1 an exemplary surgical instrument designated 
generally by reference numeral 10. Surgical instrument 10 includes three 
main structural portions, namely frame 12, tissue piercing assembly 14, 
and tool assembly 16. 
Referring to FIG. 2, frame 12 includes stationary handle 18 composed of 
left half 18a and right half 18b, and barrel section 20 composed of left 
half 20 and right half 20b. Barrel section 20 forms a head member 22 at 
its proximal end adapted for placement within groove 24 of stationary 
handle 18 to permit rotation of barrel section 20 with respect to 
stationary handle 18. Barrel section 20 defines a barrel chamber 25 
adapted to contain a portion of tissue piercing assembly 14 and tool 
assembly 16. Barrel section 20 further includes a gripping portion 26 
configured to be held by the operator to facilitate the rotation of barrel 
section 20. Longitudinal slot 28 is formed in barrel section 20 and is 
adapted to permit manipulation of tissue piercing assembly 14 by the 
operator. 
Referring once again to FIG. 2, tool assembly 16 includes an actuation 
handle 30 pivotally connected to stationary handle 18 by pivot post 32 
which extends from stationary handle left half 18a through pivot hole 34 
in actuation handle 30. Control shaft 36 includes an engagement stem 38 at 
its proximal end, the engagement stem 38 attached to actuation handle 30 
by fastener members 40. Fastener members 40 are positioned through 
fastener hole 42 in actuation handle 30 and include fastener fingers 44 
which retain engagement stem 38 therebetween to secure control shaft 36 to 
actuation handle 30. 
With continuing reference to FIG. 2, tool assembly 16 is associated with 
the distal end of control shaft 36. Tool assembly 16 includes a jaw 
housing 48, and a pair of cooperating jaw members 50 and 52 which are 
supported in jaw housing 48. Although the jaw members depicted herein are 
in the form of grasping jaws, it is envisioned that the jaw can take the 
form of biopsy forceps, cutting blades, needle holding jaws or dissecting 
jaws. Other jaw structures can also be employed. The construction and 
operation of tool assembly 16 is discussed in greater detail hereinbelow. 
Referring once again to FIG. 2, control shaft 36 is slidably disposed 
through outer tube 53. Outer tube 53 is fixedly secured at a proximal end 
to bushing 54 and at a distal end to jaw housing 48. Bushing 54 is fixedly 
disposed within groove 56 in stationary handle 18 and is adapted to permit 
rotation of control shaft 36 within bushing 54. 
Referring now to FIG. 1 in conjunction with FIG. 2, in operation, the jaw 
members 50 and 52 of tool assembly 16 are moved between an open position 
and a closed position through manipulation of actuation handle 30. As best 
seen in FIG. 1, pivotal movement of actuation handle 30 in the direction 
indicated by arrow "A" causes fastener members 40 to urge engagement stem 
38 in a proximal direction. As a result, control shaft 36 is pulled in a 
proximal direction, drawing therewith a cam pin 58 which is associated 
with the distal end of control shaft 36 and jaw members 48 and 50. More 
specifically, as best seen in FIG. 2, cam pin 58 is dimensioned and 
configured to translate relative to a pair of angled cam slots 60 and 62 
formed in jaw members 50 and 52 respectively. As cam pin 58 moves relative 
to cam slots 60 and 62, jaw members 50 and 52 move between open and closed 
positions as they pivot about a common pivot pin 64 which is supported in 
jaw housing 48. 
Referring again to FIGS. 2-3, tissue piercing assembly 14 includes an 
elongated tubular member 66 having an axial bore 68 receiving control 
shaft 36 therethrough. Tubular member 66 defines a longitudinal axis and 
forms a tissue piercing portion 70 at its distal end. Control assembly 72 
is disposed within barrel chamber 25 of barrel section 20 and is 
operatively associated with tubular member 66 of tissue piercing assembly 
14 to control the longitudinal movement of tubular member 66 in relation 
to barrel section 20 of frame 12. 
Referring to FIG. 3, control assembly 72 includes cam support member 74 
mounted to tubular member 66 for conjoint axial motion. Flexible arm 76 
extends from the body 78 of cam support member 74 and has an inclined cam 
face 80. Flexible arm 76 extends substantially parallel to body 78 of cam 
support member 74 and is deflectable relative to cam support member 74 
through deflection in the "J-shaped" region 82 which joins the flexible 
arm 76 to the body 78 of the cam support member 74. Cocking spring 84 is 
anchored at a proximal end to cam support member 74 by post 85 and at a 
distal end to housing 86 by peg 87 and functions as described in detail 
hereinbelow. 
With continuing reference to FIG. 3, the housing 86 is composed of top half 
86a and bottom half 86b and is slidable within barrel section 20 of frame 
12. Housing 86 includes a pair of outwardly directed spacers 88 formed on 
housing 86 which are adapted to maintain a clearance between housing and 
the inside wall (not shown) of barrel section 20. Return spring 90 is 
anchored at a proximal end to barrel section 20 by post 91 and at a distal 
end to housing 86 by post 92. An L-shaped catch 94 is pivotally mounted on 
post 95 of housing 86 and includes a latching face 96. Catch 94 further 
includes a downwardly extending catch arm 97 to which is mounted the 
distal end of a catch spring 98, the proximal end of catch spring 98 
mounted to the housing 86. An angular camming face 89 is formed on catch 
94 facing flexible arm 76 of cam support member 74. On the inside wall of 
barrel portion 20 is a ledge 93 against which latching face 96 of catch 94 
engages when the instrument is "armed". 
Referring now to FIG. 4, surgical instrument 10 is shown at a "rest" 
position with tool assembly 16 extending distally out from the distal end 
of tubular member 66. Referring to FIGS. 5-8, in operation the surgeon 
advances housing 86 distally relative to barrel section 20 by advancing 
distally a push button 83 (FIGS. 1 and 3) mounted to housing 86 and 
protruding through slot 28 in barrel section 20, thereby loading return 
spring 90. Housing 86 and cam support member 74 travel conjointly until 
such time as the front face 75 of the cam support member 74 contacts the 
distal wall 27 of barrel section 20 as shown in FIG. 5. At this point, 
further distal advancing of cam support member 74 is arrested, and further 
distal advancing of housing 86 causes cocking spring 84 to be loaded, that 
is, the housing 86 travels distally relative to the cam support member 74 
thereby stretching cocking spring 84. As a result of this relative motion, 
the inclined cam face 80 on flexible arm 76 comes into contact with catch 
94 as shown in FIG. 6. 
Referring once again to FIG. 6, further distal movement of housing 86 and 
resultant contact between inclined cam face 80 of flexible arm 76 and 
catch 94 cause J-shaped region 82 to deflect as it comes into contact with 
catch 94. The relative positions and dimensions of the components are such 
that, when "fully armed" as shown in FIG. 7, the inclined cam face 80 is 
in contact with and deflected by the catch 94. If the surgeon released 
push button 83 at this point, the return spring 90 would cause immediate 
return of the housing 86 and the cam support member 74, to the rest 
position but for engagement between latching face 96 on catch 94 the ledge 
93 on the inside wall of barrel section 20. The stroke of the housing 86 
and cam support member 74 relative to barrel section 20 is such that 
tissue piercing portion 70 of tubular member 66 extends distally beyond 
tool assembly 16 when fully armed. 
With reference to FIGS. 7-8, the surgeon now presses the tissue piercing 
portion 70 of tubular member 66 against the skin. The counterforce exerted 
by the skin causes tubular member 66, and therefore cam support member 74, 
to travel proximally, thereby further loading cocking spring 84 but, more 
importantly, placing the inclined cam face 80 of flexible arm 76 proximal 
of the angular camming face 89 of catch 94 where it assumes its 
non-deflected configuration in the plane of the catch 94. When the tissue 
piercing portion 70 of tubular member 66 pierces through the skin as shown 
in FIG. 8, the counterforce of the skin disappears, allowing the cocking 
spring to effect distal movement of the cam support member 74 relative to 
the housing 86. The inclined cam face 80 contacts the angular camming face 
89 on the catch 94, causing counterclockwise pivotal motion of catch 94 
against the bias of catch spring 98 removing latching face 96 out of 
engagement with ledge 93. Thus, the return spring 90 is unopposed and 
causes immediate retraction of the housing 86, and conjointly the cam 
support member 74, relative to barrel section 20. As a result, tissue 
piercing portion 70 of tubular member 66 is retracted proximal to tool 
assembly 16. 
Referring now to FIG. 1 in conjunction with FIG. 8, with tool assembly 16 
extending distal that of tissue piercing portion 70, tool assembly 16 can 
be manipulated by movement of actuation handle 30 to perform the surgical 
procedure. 
In summary, the tissue piercing portion 70 of tubular member 66 immediately 
and automatically retracts upon entry through the skin placing the tool 
assembly 16 in position for use beyond the tissue piercing portion 70. 
Once exposed, the tool assembly 16 performs dual purposes, i.e., a safety 
function by protecting the tissue piercing portion 70 from contacting 
internal organs and a manipulation function by acting upon those same 
internal organs. 
FIG. 9 illustrates an exemplary introducer 100 which may be used with a 
surgical instrument of the type shown in FIGS. 1-8. The introducer 100 
includes a stabilizing structure 101 for stabilizing a surgical instrument 
at the surface of the body tissue adjacent where the surgical operation is 
to be performed. An accessing element 102 is coupled to the stabilizing 
structure 101 for establishing an opening through the body tissue surface 
layer and for providing a conduit for passage by a surgical instrument for 
accessing body tissue at the surgical site. The tissue piercing assembly 
14 is used in conjunction with the stabilizing structure 101 and the 
accessing element 102 for puncturing through the body tissue surface 
layer. 
As shown in FIGS. 9 and 10, stabilizing structure 101 includes a 
substantially circular skirt portion 106 and a longitudinally extending 
collar portion 108. Collar portion 108 defines a bore 199 extending 
proximally from the skirt portion 106 for receiving tissue piercing 
assembly 14 of surgical instrument 10. The skirt and the collar portions 
106, 108 are preferably insert molded or over-molded to form a unitary 
assembly. Skirt portion 106 is preferably made of a flexible material such 
as polyurethane or polyethylene. A spring clamp 107 is preferably used to 
compress and secure an inserted surgical instrument within the stabilizing 
structure 101. The clamp 107 is preferably one which applies a tightening 
tension to a clamped object when no force is applied to the handles 198 of 
the clamp 107. The clamp 107 releases the clamped object when a force is 
applied at the handles 198. The collar portion 108 includes an annular 
notch 111 for seating clamp 107. 
Alternative clamping structures 207 and 307 for applying a securing force 
to stabilizing structure 101 are illustrated in FIGS. 14A and 14C 
respectively. Referring to FIG. 14A, clamping structure 207 includes first 
and second pivotally connected clamp arms 210 and 212 which are normally 
biased into a clamping position by an internal torsion spring 214. An 
aperture 216 is defined at the distal end of clamp arm 210 for receiving 
stabilizing structure 101 and a clamp finger 218 is defined at the distal 
end of clamp arm 212 for engaging stabilizing structure 101 when clamping 
structure 207 is in the clamping position illustrated in FIG. 14B. 
Referring to FIG. 14C, clamping structure 307 is of unitary construction 
and includes opposed clamping portions 310 and 312, a bridge portion 314 
connecting the two clamping portions, and an integral locking assembly 316 
formed opposite bridge portion 314. An aperture 318 is formed in bridge 
portion 314 for receiving stabilizing structure 101. A strut 320 depends 
inwardly from clamping portion 310 and a protuberance 322 depends inwardly 
from clamping portion 312 to engage stabilizing structure 101 at 
diametrically opposed locations on its periphery. Locking assembly 316 
includes a spring leg 324 which depends from clamping portion 312. A tooth 
326 is formed at the end of spring leg 324 for engaging a corresponding 
tooth 328 formed on clamping portion 310 to lock clamping structure 307 in 
the clamped position illustrated in FIG. 14D. 
Referring again to FIGS. 9 and 10, the skirt portion 106 includes an 
adhesive layer 105 on the tissue engaging surface thereof. Preferably, the 
adhesive is a medically acceptable adhesive suitable for contacting body 
tissue surface or skin without medically adverse effects, e.g., a suitable 
rubber based adhesive. The adhesive layer 105 may be covered by release 
sheets 104A and 104B until ready for application to the body tissue 
surface. Release sheets 104a and 104b are semicircular in shape and sized 
to cover the entire adhesive layer of the skirt portion 106 for protecting 
the adhesive layer 105. 
When the stabilizing structure 101 is ready for positioning at the body 
tissue surface adjacent to the surgical site, the release sheets 104a and 
104b are removed by pulling on release tabs 104c and 104d to expose the 
adhesive layer 105. The stabilizing structure 101 is then ready for 
insertion and placement. 
When removal of the stabilizing structure 101 from the body tissue surface 
is desired, skirt tab 120 is lifted and the skirt portion 106 is peeled 
away from the body tissue surface. The adhesive layer 105 of the skirt 
portion 106 is configured for releasably securing the stabilizing 
structure 101 and thereby the introducer 100 relative to the body tissue 
surface. The material of construction of the stabilizing structure 101 
facilitates conformance of the skirt portion 106 to the contours of the 
body tissue surface, providing form fitting engagement and therefore 
strong adhesion of the skirt portion to the body tissue surface. It is 
understood that the skirt portion 106 is not limited to being circular, 
but may vary in shape, such as oval or rectangular. 
According to the embodiment of FIGS. 9 and 10, the skirt portion 106 is 
approximately two inches in diameter and has a thickness of approximately 
0.05 inch at the outer circumferential portion thereof. Referring to FIG. 
13, toward the center of the skirt portion 106, there is an upward 
elevation at a pitch of approximately 30.degree., and then leveling at 
approximately 0.25 inch from the center, forming a second circular opening 
or void 197 which is also concentric to the bores 199 of the stabilizing 
structure 101 and the first opening 196 of the skirt portion. The second 
opening 196 is in the same shape and size as shown for circular flange 109 
of accessing element 102. 
The collar portion 108 extends proximally and longitudinally from the skirt 
portion 106. The collar portion 108 is preferably circular and has an 
outer diameter of approximately 0.28 inch and a bore 199 having a diameter 
constricted for facilitating the passage of a surgical instrument 
therethrough. As can be seen in FIG. 13, a seal 201 extends radially into 
the bore for frictionally engaging the outer surface of an inserted 
surgical instrument to form a seal. 
Again referring to FIGS. 9, 10 and 13, an accessing element 102 includes a 
longitudinal bore 195 extending distally from the stabilizing structure 
101. A circular flange 109 is disposed at the proximal end thereof for 
coupling to the skirt portion 106 of the stabilizing structure 101. The 
accessing element 102 extends longitudinally from the circular flange 109 
and further includes a tapered distal end portion 112 for accessing body 
tissue and expanding an opening in body tissue. The longitudinal bore 195 
of the accessing element 102 preferably has an inner bore diameter which 
corresponds to the inner diameters of bores 199 and 197. When the 
accessing element 102 is coupled to the stabilizing structure 101, the 
longitudinal bore 195 of the accessing element 102 is in concentric 
alignment and communication with the longitudinal bore 197 of the 
stabilizing structure 101. 
Referring to FIGS. 9-12, the introducer 100 is used with the tissue 
piercing assembly 14 for puncturing body tissue. The tissue piercing 
assembly 14 is slightly smaller in diameter than the longitudinal bore 197 
of the stabilizing structure 101 and accessing unit 102 for passage 
therethrough. 
Referring to FIG. 11, the accessing element 102 is coupled to the 
stabilizing structure 101 while tubular portion 66 of tool assembly 16 is 
inserted through the longitudinal bore of the stabilizing structure 101 
and accessing element 102, until the tissue piercing portion 70 extends 
beyond the distal end portion of the accessing element 102. The tubular 
portion 66 is secured within the introducer 100 by clamp 107. The 
introducer 100, as shown in FIG. 11, is ready for application to the body 
tissue surface and for accessing the surgical site. 
FIG. 12 illustrates the introducer 100 having been positioned in the body 
tissue surface layer 402 subsequent the piercing of the body tissue 
surface layer 401 by tissue piercing assembly 14. Prior to insertion, 
release sheets 104a and 104b are removed to expose adhesive layer 105. Of 
course, the surgeon may choose to expose adhesive layer 105 after 
penetration is accomplished, if desired. The introducer 100 is affixed to 
body tissue surface 410 by adhesive layer 105. The flexible 
characteristics of the stabilizing structure 101 and skirt portion 106 
allow conformity of the skirt portion 106 even if there are contours in 
the body tissue surface 410. This forms a strong bank to secure the 
introducer 100 to the body tissue surface 401. Tool assembly 16 can now be 
manipulated to perform the surgical procedure. 
However, as illustrated in FIGS. 14-16, the introducer 100 may also be used 
in conjunction with an obturator 103. The obturator 103 includes a sharp 
tip portion 110 at its distal end for puncturing body tissue. The outer 
surface of the proximal end portion 120 is diamond-knurled for providing 
non-slip engagement with the user. The operation of the introducer 100 
with the obturator 103 is described in detail hereinbelow. 
Referring again to FIG. 13, spring 107 is seated in its tension-applied 
position at annular notch 111. It can be seen that without a surgical 
instrument inserted in the stabilizing structure 101, the tension from 
spring 107 causes the flexible material of the stabilizing structure 101 
to flex in an inward direction into the bore of the collar portion 108. 
As shown in FIG. 14, the accessing element 102 is coupled to the 
stabilizing structure 101 while the obturator 103 is inserted through the 
longitudinal bore of the stabilizing structure 101 and accessing element 
102, until the obturator tip 110 extends beyond the distal end portion of 
the accessing element 102. The obturator 103 is secured within the 
introducer 100 by clamp 107. The introducer 100, as shown in FIG. 14, is 
ready for application to the body tissue surface and accessing the 
surgical site. 
FIG. 15 illustrates the introducer 100 being used to puncture the body 
tissue surface layer 401 by applying a vertically downward force into the 
body tissue surface. Prior to penetration, the release sheets 104a and 
104b are removed to expose adhesive layer 105. Of course, as described 
above, the surgeon may choose to expose adhesive layer 105 after 
penetration is accomplished, if so desired. 
FIG. 16 illustrates the introducer 100 after penetrating the body tissue 
surface layer 402 and with the obturator 103 removed. As shown, the 
introducer 100 is affixed to body tissue surface 401 by adhesive layer 
105. Once again, the flexible characteristics of the stabilizing structure 
101 and skirt portion 106 allow conformity of the skirt portion 106 even 
if there are contours in the body tissue surface 401. This forms a strong 
bond to secure the introducer 100 to the body tissue surface 401. The 
introducer 100 is now positioned to receive tubular member 66 of tissue 
piercing assembly 14 through the bore 199 of the stabilizing structure 101 
and accessing element 102 as shown in FIG. 17. Accessing element 102 
establishes an opening and isolates the tissues surrounding the accessing 
element 102 so that surgical instruments can be withdrawn or inserted 
through the longitudinal bore 99 without having to re-establish or find 
the opening each time a surgical instrument is replaced. Advantageously, 
the flexible characteristic of the stabilizing structure 101 and the 
flexible coupling arrangement of the accessing element 102 to the 
stabilizing structure 101 facilitate ample flexible movement of an 
inserted surgical instrument. 
Upon completion of the surgical procedure, or if the introducer 100 needs 
to be released from the body tissue surface 401, tab 120, (FIG. 14) is 
lifted to release the adhesive layer 105 and the introducer 100 from the 
body tissue surface 401. 
Referring now to FIGS. 18 and 19, an alternative introducer 600 is shown. 
The stabilizing structure 601 includes skirt portion 606 which is 
substantially the same in function as the skirt portion 106 of the 
embodiment of FIG. 9. The collar portion 608 includes a constricted bore 
699, which has a smaller bore diameter opposite the annular notch 611 than 
the bore diameter adjacent the proximal end. This configuration 
facilitates the passage of a surgical instrument and the smaller bore 
diameter forms a seal against the inserted surgical instrument. Accessing 
element 602 comprises a circular flange 609 for coupling to the circular 
void 196 of the skirt portion 606 of the stabilizing structure 600, 
essentially as described above. The accessing element 602 further includes 
a conical stub 612, which extends longitudinally from the skirt portion 
106. The conical stub 612 tapers distally to form a penetrating tip at the 
distal end for penetrating the body tissue surface. Such configuration 
eliminates the need for a separate obturator such as obturator 103 
discussed above. 
Referring to FIG. 19, the accessing element 602 preferably includes a bore 
599 which is concentric to and in communication with the bore 699 of the 
stabilizing structure 601 when the accessing element 602 is coupled to the 
stabilizing structure 601. Slit openings 630 essentially divide the 
conical stub 612 into four equilateral portions, thereby facilitating the 
separation and the spreading apart of the conical stub 612 radially 
outwardly when a surgical instrument is inserted through the bore of the 
stabilizing structure 606 and the accessing element 602. (See FIG. 22) 
Accessing element 602 is preferably made from a semi-rigid material such 
as, for example, a biocompatible plastic. 
Advantageously, the introducer 600 provides integral means for 
percutaneously accessing a surgical site beneath the body tissue surface 
while establishing a fixed point of entry of a surgical instrument, 
without any contact between the body tissue surface layer and the surgical 
instrument, regardless the number of times of entries, withdrawal, or 
replacements of surgical instruments through the introducer 600. 
FIGS. 20, 21 and 22 illustrate a preferred use of introducer 600. In FIG. 
21, the penetrating tip of the conical stub 612 is used to create an 
opening in the body tissue surface 801 by a downward force on the 
introducer 600. The release sheets (not shown) have already been removed 
to expose the adhesive layer 105. FIG. 19 shows the introducer in place 
with the skirt portion 106 affixed to the body tissue surface 801 by the 
adhesive from the adhesive layer 105, thereby stabilizing the introducer 
600. The conical stub 612 is shown to have cleared the body tissue surface 
layer 802 to expose the tip portion. If the thickness of body tissue 
surface layer is larger than the length of the conical stub 612, a 
cauterizing instrument may be inserted to contact the conical stub 612 to 
cauterize the contacting tissue. 
FIG. 22 illustrates the introducer 600 with tubular member 66 of tissue 
piercing assembly 14 inserted therethrough and with tool assembly 16 in 
position to perform a surgical procedure. It can be seen that tubular 
member 66 has been inserted through the concentric bores of the collar 
portion 601 and skirt portion 606 of the stabilizing structure, and the 
circular flange 609 and the conical stub 612 of the accessing element 602. 
The conical stub 612 has radially parted from the slit against the tissue 
of the body tissue surface layer which surrounded the four portions. The 
clamp 107 clamps the tubular member 66 to the collar portion 101 and 
secures the tubular member 66 to the introducer 600. The tubular member 66 
may be manipulated in a side-to-side or radial direction while secured to 
the introducer 600. It can be seen that the seal 201, which protrudes into 
the bore of the stabilizing structure, frictionally engages the tubular 
member 66 to form one seal and a second seal is formed by the engagement 
of the tubular member 66 with the smaller diameter portion of bore 699 
opposite the annular notch 611. The surgical instrument 10 is shown, by 
way of an example, as a grasping instrument. It is understood that any 
surgical instrument, such as shears or a stapler, having a suitable shaft 
diameter for insertion through the introducer may be used. 
FIG. 23 illustrates another introducer embodiment. All aspects of the 
introducer 700 are the same as introducer 600 discussed above except that 
the accessing element 702 includes an elongated portion 703 between the 
circular flange 709 and the conical stub 712. The elongated portion 703 
extends longitudinally to the conical stub 712 which tapers distally to 
form a penetrating tip 710. 
In a preferred use, the introducer 700 is the same as described and shown 
in FIGS. 20-22. The length in the accessing element 702 is to accommodate 
surgical sites where the body tissue surface layer is thicker. In cases 
where the surgeon anticipates frequent insertion and reinsertion of 
surgical instruments through the introducer 700, which causes movement and 
disruption to the tissues of the body tissue surface layer surrounding the 
introducer 700, introducer 700 is preferred because the elongated portion 
of accessing element 702 ensures the clearance of the conical stub 712 
from the body tissue surface layer. 
It will be understood that various modifications can be made to the various 
embodiments herein disclosed without departing from the spirit and scope 
thereof. For example, various working members can be substituted for the 
graspers, dissectors, and surgical shears as appropriate for the 
particular procedure to be performed. In addition, for example, various 
sizes of the surgical instrument are contemplated, as well as various 
types of construction materials. Also, various modifications may be made 
in the configuration of the parts. For example, the skirt portion of the 
stabilizing structure may be rectangular rather than circular. The 
accessing element may be an integral unit of the stabilizing structure 
instead of a force fitting element. Therefore, the above description 
should not be construed as limiting the application but merely as 
exemplifications of preferred embodiments thereof. Those skilled in the 
art will envision other modifications within the scope and spirit of the 
present disclosure as defined by the claims appended hereto.