US20090131871A1 - Trocar insertion apparatus - Google Patents

Abstract

Apparatus for forming and enlarging a percutaneous penetration are disclosed. The apparatus includes an elongate dilation member including a radially expandable member having a first cross-sectional area; and an elongate expansion member including a tubular element having a second cross-sectional area which is larger than the first cross-sectional area. 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 being connected so that operation of the operation member approximates the first engaging feature and the second engaging feature together.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• 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
• 1. Technical Field
• 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.
• 2. Background of Related Art
• 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's skin, tissue, etc. adjacent the surgical site.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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'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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Desirably, manipulation of the trigger towards the handle incrementally approximates the yoke toward the expansion assembly retaining structure.
• 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.
• 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.
• 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.
• It is envisioned that the proximal end of the spine member may extend from a proximal end of the handle.
• 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.
• 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.
• The kit may further include a package insert including at least one of instructions on use and warnings of use.
• 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
• 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.
• FIG. 1 is a side elevational view of a radially expandable dilation assembly for sealing a percutaneous opening in a patient;
• 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;
• FIG. 3 is a partly separated side elevational view of a cannula assembly of an elongate expansion assembly;
• FIG. 4 is a side elevational view of an obturator component for use with the elongate expansion assembly ofFIG. 3;
• 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;
• 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;
• FIGS. 7-10 illustrate use of the expansion assembly insertion apparatus in connection with the dilation assembly ofFIG. 1 and the expansion assembly ofFIG. 2 for facilitating insertion of the expansion assembly in to the dilation assembly; and
• 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
• 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.
• Referring now in detail to the drawing figures, as seen inFIG. 1, a radially expandable dilation assembly is generally designated with thereference numeral10. Radiallyexpandable dilation assembly10 includes atubular sheath12 having aproximal end14, adistal end16 and anaxial lumen15 extending therethrough.Axial lumen15 defines a longitudinal axis “X” and further defines a first cross-sectional area extending therethrough.Proximal end14 is tapered radially outward in the proximal direction and is secured to ahandle18.Handle18 includes anaperture20 extending therethrough and interconnected withlumen15 oftubular sheath12.Tubular sheath12 may be made from any material which is capable of receiving an expansion assembly to effect radial expansion ofsheath12, as described in more detail hereinafter.
• Sheath12 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. Suitableexpandable sleeves10 may be obtained commercially from United States Surgical, a division of Tyco Healthcare, Ltd., as part of the STEP™ introducer system.
• Apneumoperitoneum needle assembly30 including atubular needle32 and astylet34 is illustrated inFIG. 2.Tubular needle32 includes ahub36 having amale bayonet connector38 at a proximal end thereof. Preferably,stylet34 is spring loaded in aproximal connector40 which includes a male bayonet fitting42. Male bayonet fitting42 is receivably coupled to female bayonet fitting (not illustrated) ofhub36. Aninsufflation valve44 is connected to the proximal end ofstylet34 and aport46 is formed in a distal end thereof.Port46 permits the introduction of insufflation gas throughvalve44 to be released throughstylet34. In use,stylet34 is mounted withinneedle32 with bayonet fitting42 attached tohub36. The distal end ofstylet34 in turn extends from adistal end48 ofneedle32 such thatstylet34 will retract intoneedle32 whenneedle assembly30 is engaged against tissue, as described in more detail below.
• Referring now toFIG. 3, anexpansion assembly50 is shown and described.Expansion assembly50 includes an expansion member52 (i.e., a cannula tube) and aproximal hub54.Expansion member52 includes a threadedconnector56 at its proximal end which can be removably secured to a fitting58 in the distal end ofproximal hub54. Preferably,expansion member52 defines a second cross-sectional area which is larger than the first cross-sectional area oftubular sheath12.
• With reference toFIG. 4, anobturator70 including ashaft72 having a tapereddistal end74 and ahandle76 is shown and described. As will be described in greater detail below,obturator70 is intended to be placed within a central lumen ofcannula assembly50 in order to facilitate insertion ofexpansion assembly50 into radiallyexpandable dilation assembly10.
• Turning now toFIG. 5, an expansion assembly insertion apparatus in accordance with the present disclosure, having anexpansion assembly50 and adilation assembly10 operatively mounted thereto, is shown generally asreference numeral100.Insertion apparatus100 includes a proximally extending fixedhandle102, atrigger104 pivotably coupled to fixedhandle104 atpivot pin118, and a distally extendingspine member106.Spine member106 has adistal end108 and aproximal end110 defining a longitudinal axis “X′”.Proximal end110 ofspine member106 is slidably received within fixedhandle102 through anaperture102aformed in a distal end of fixedhandle102. While a generally rectangular cross-section forspine member106 has been depicted it is contemplated thatspine member106 can have a circular, elliptical, square or other polygonal cross-section.
• Distal end108 ofspine member106 is provided with a yoke or engagingfeature112 operatively coupled thereto.Yoke112 defines aU-shaped clevis114 having a pair of legs116,117. Preferably,clevis114 includes a distal pair oflegs116a,117aand a proximal pair oflegs116b,117b. Legs116,117 define an axis which is substantially parallel to the longitudinal “X′” axis ofspine member106. In use,U-shaped clevis114 ofyoke112 receives handle18 ofdilation assembly10 therein. In particular, handle18 includes a pair of diametricallyopposed tabs18a,18bwherein eithertab18aor18bis positioned between distal andproximal legs116aand116bwhile the other oftab18aor18bis positioned between distal andproximal legs117aand117b.
• As best seen inFIG. 6, fixedhandle102 includes an actuation mechanism for the mechanical operation ofinsertion apparatus100. The actuation mechanism includes alinkage member120 having afirst end120awhich is pivotably coupled to trigger104 at apivot point122 and asecond end120bwhich is slidably received within fixedhandle102 and pivotably coupled to a drivinglever130.
• Drivinglever130 is located and/or suspended onspine member106 which passes through an aperture oropening132 formed in drivinglever130. Acompression spring134 disposed between drivinglever130 and an inner surface of fixedhandle102urges driving lever130 in a distal direction and to remain orthogonal relative tospine member106. The force ofspring134 urges trigger104 against abacking member126, vialinkage member120, of fixedhandle102 thus providing a standby condition. In the standby condition, drivinglever130 is positioned substantially perpendicular to the direction of motion, indicated by the arrow “P”, ofspine member106 when in operation. Motion oftrigger104 about thepivot pin118 causesspine member106 to move against the bias ofspring134, as will be described in greater detail below.
• The actuation mechanism further includes abraking lever136 having anopening138 through whichspine member106 passes. Oneend140 ofbraking lever136 is pivotably positioned in arecess142 formed in fixedhandle102 such thatbraking lever136 may pivot within constraints defined by the surfaces ofrecess142 and by the binding ofbraking lever136 withspine member106 when the edges of opening138 inbraking lever136 engage the surfaces ofspine member106. At least onecompression spring144 is disposed between awall146 in fixedhandle102 andbraking lever136.Spring144 effectively biases the free end ofbraking lever136 distally away from drivinglever130. The biased position ofbraking lever136 is limited by the binding and/or cocking interference betweenopening138 ofbraking lever136 and the surfaces ofspine member106. In the embodiment illustrated inFIG. 6,braking lever136 extends in the direction of fixedhandle102 so that itsdistal end148 can be suitably gripped by the thumb of a user.
• It should be noted that in the standby position illustrated inFIG. 6, drivinglever130 is substantially perpendicular to the longitudinal “X′” axis ofspine member106, whereas the portion ofbraking lever136 which engagesspine member106 is transversely oriented to the longitudinal “X′” ofspine member106 at a slight angle. In this condition, if a force is applied to yoke112 (FIG. 5) in the direction indicated by arrow “P”,slide member106 is free to move through fixedhandle102. Since brakinglever136 is free to pivot against the bias ofspring144 when force is applied onyoke112, in the direction of arrow “P”,braking lever136 presents no obstacle to the motion ofspine member106 andyoke112 and thus may be advanced continuously through fixedhandle102.
• However, in the standby position, as illustrated inFIG. 6, if a force is applied toyoke112 in the direction opposite to the direction indicated by arrow “P”, the edges of opening138 inbraking lever136 bind against the surfaces ofspine member106 and it is not possible to withdraw the movingyoke112 further away from fixedhandle102. Compression ofspring144, by pressing onbraking lever136 with a finger in the direction of the arrow “P”, allows withdrawal ofspine member106 andyoke112 to be extended away from fixedhandle102. Compression ofspring144 bringsdistal end148 ofbraking lever136 into perpendicularity with the direction of intended motion ofspine member106, and thusspine member106 is then free to slide in either direction throughopening136 inbraking lever136.
• The preferred method of use of expansionassembly insertion apparatus100 is to squeeze trigger104 (toward fixed handle102) to incrementally advancespine member106 andyoke112 through fixedhandle102. Whentrigger104 is squeezed, pivoting occurs aboutpivot pin118 andsecond end120boflinkage member120 also moves substantially in the direction of arrow “P”. This causes drivinglever130 to pivot about itsfirst end131 so that drivinglever130 is no longer perpendicular to the direction “P” of intended motion ofspine member106. Pivoting of drivinglever130 compressesspring134 and also causes the end edges ofaperture132, formed in drivinglever130 to bind against the surfaces ofspine member106. Binding occurs because drivinglever130 is no longer perpendicular to the direction “P” of intended motion ofspine member106. Further motion oftrigger104causes driving lever130 to translate in the direction of arrow “P”. This motion further compressesspring134 and in the process, by means of the binding and/or cocking interference between drivinglever130 andspine member106, advancesspine member106 and itsconnected yoke112 through fixedhandle102. The maximum distance of advancement ofyoke112, with one squeeze oftrigger104, is limited to whenspring134 is fully compressed or trigger104 strikes the surface of fixedhandle102.
• Aftertrigger104 is fully pivoted aboutpivot pin118, release oftrigger104 causes the return oftrigger104 to the stand by condition due tospring134urging driving lever130 to a perpendicular position andpressing linkage member120 intotrigger104.
• Returning toFIG. 5, fixedhandle102 is further provided with at least one, preferably a pair of resilient C-shapedcuffs124 affixed to a distal end thereof.Cuffs124 define a longitudinal axis which is substantially aligned with the axis ofclevis114 defined by legs116,117. In use,cuffs124 are configured to receiveproximal hub54 ofcannula assembly50 therein by a snap-fit type engagement.
• In addition, fixedhandle102 is provided with abacking member126 as described above. Backingmember126 preferably extends transversely fromfixed handle102 beyond the longitudinal axis ofcuffs124. Accordingly, in operation, backingmember126 preferably acts as a stop for a proximal end surface ofexpansion assembly50 whenexpansion assembly50 is mounted to expansionassembly insertion apparatus100.
• Whileinsertion apparatus100 has been shown and described herein as including atrigger104 for incrementally approximating clevis114 towardcuffs124, 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 clevis114 towardcuffs124.
• Referring now toFIGS. 7-10, a preferred method of operation of expansionassembly insertion apparatus100, will be described. Initially, as seen in FIG. radiallyexpandable dilation assembly10, havingpneumoperitoneum needle assembly30 inserted therein, is introduced through a patient's abdomen “A” (or other body location) by engaging sharpeneddistal end48 ofneedle assembly30 against the tissue of the patient's abdomen “A” and advancing the sleeve/needle combination forward untiltubular sheath12 ofdilation assembly10 extends across the tissue of abdomen “A”.
• Needle assembly30 is then removed, and anexpansion assembly50 including anobturator70 disposed therewithin is introduced throughtubular sheath12 ofdilation assembly10, with the aid of expansionassembly insertion apparatus100 thereby resulting in radial expansion of tubular sheath12 (seeFIG. 9). In particular,yoke112 ofinsertion apparatus100 is preferably first hooked ontohandle18 ofdilation assembly10 as described above. Next,expansion assembly50, includingobturator70, is loaded intoinsertion apparatus100 by couplingproximal hub54 ofexpansion assembly50 tocuffs124 as described above. Finally,insertion apparatus100 is actuated by repeatedly squeezingtrigger104, as described above, in order to incrementally advanceexpansion assembly50 andobturator70 throughdilation assembly10. Asexpansion assembly50 andobturator70 are moved distally throughtubular sheath12,dilation assembly10 is radially expanded from the first cross-sectional area to the second cross-sectional area.
• Finally, as illustrated inFIG. 10,obturator70 is removed fromexpansion member52, leaving an access channel through abdominal wall “A” for the introduction of a variety of other surgical instruments through the access channel.
• An ergonomic feature ofinsertion apparatus100 is the substantially longitudinally oriented fixedhandle102 andtrigger104. In other words, fixedhandle102 is preferably aligned with the longitudinal axis ofspine member106 whiletrigger104 is preferably pivotable to a closed position which is substantially aligned with the longitudinal axis ofspine member106. Thus, the longitudinal axis ofinsertion apparatus100 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 fixedhandle102 and trigger104 and pivoting his forearm about his elbow such that is hand travels in a direction substantially co-linear with the longitudinal axis ofinsertion apparatus100.
• Turning now toFIG. 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.
• As seen inFIG. 11, anexemplary kit200, for providing access to a target surgical site, includes apackage202, typically non-sterile since the reusable components can be subsequently sterilized and at least one of the following items: a radiallyexpandable dilation assembly10; apneumoperitoneum needle assembly30; astylet34; anexpansion assembly50; and anobturator70.Kit200 further includes an expansionassembly insertion apparatus100.
• 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.

Claims (20)

1. An insertion apparatus for use in connection with an expandable member insertable into an opening in a patient's tissue and a dilation member removably positionable with the expandable member to enlarge the opening, the insertion apparatus comprising:

a first arm extending along a longitudinal axis that is configured and dimensioned to receive the expandable member such that axial movement of the expandable member is restricted with respect to the tissue following insertion of the expandable member to thereby minimize trauma upon repositioning of the dilation member; and

a second arm operatively connected to the first arm, the second arm being configured and dimensioned to receive the dilation member to establish and maintain relative axial alignment between the expandable member and the dilation member.

2. The insertion apparatus ofclaim 1, further including a first engaging feature coupled to the first arm and a second engaging feature coupled to the second arm, the first engaging feature being configured and dimensioned to retain the expandable member and the second engaging feature being configured and dimensioned to retain the dilation member.

3. The insertion apparatus ofclaim 2, wherein the first engaging feature includes a first pair of legs spaced axially from a second pair of legs to define a gap therebetween, the gap being configured and dimensioned to receive the expandable member such that relative axial movement between the expandable member and the first engaging feature is substantially prevented.

4. The insertion apparatus ofclaim 2, further including an operation member operatively connected to at least one of the first and second arms to effectuate relative axial movement between the first and second arms upon actuation of the operation member.

5. The insertion apparatus ofclaim 4, wherein the operation member is attached to the second arm.

6. The insertion apparatus ofclaim 4, wherein the first arm is slidably received by the second arm such that actuation of the operation member effectuates approximation of the first engaging feature and the second engaging feature.

7. The insertion apparatus ofclaim 4, wherein the operation member includes a first handle and a second handle, the second handle being fixedly positioned relative to the first arm and substantially aligned with the longitudinal axis defined thereby.

8. The insertion apparatus ofclaim 7, wherein the first handle is movably relative to the second handle to actuate the operation member.

9. The insertion apparatus ofclaim 8, wherein the first handle is pivotably connected to the second handle for repositioning between an open position, in which the first handle is misaligned with the longitudinal axis, and a closed position, in which the first handle is substantially aligned with the longitudinal axis, wherein movement of the first handle from the open position to the closed position actuates the operation member.

10. A method of forming and enlarging an opening in tissue comprising the steps of:

providing an expandable member removably positionable within the opening;

providing a dilation member positionable within and movable through the expandable member;

providing an insertion apparatus having proximal and distal ends and including a first arm movably connected to a second arm, the first arm being configured and dimensioned to receive the expandable member such that axial movement of the expandable member is restricted with respect to the tissue following insertion of the expandable member to thereby minimize trauma upon repositioning of the dilation member, the second arm being configured and dimensioned to receive the dilation member to establish and maintain relative axial alignment between the expandable member and the dilation member:

connecting the expandable member and the first arm of the insertion apparatus;

connecting the dilation member and the second arm of the insertion apparatus;

positioning the expandable member within the opening in the tissue; and

effectuating relative movement between the first arm and the second arm of the insertion apparatus to move the dilation member through the expandable member to thereby enlarge the opening in the tissue.

11. The method ofclaim 10, wherein the step of providing an insertion apparatus includes providing an insertion apparatus further including a first engaging feature coupled to the first arm for retaining the expandable member and a second engaging feature coupled to the second arm for retaining the dilation member.

12. The method ofclaim 11, wherein the step of providing an insertion apparatus includes providing an insertion apparatus wherein the first engaging feature includes a first pair of legs spaced axially from a second pair of legs to define a gap therebetween for receiving the expandable member so as to substantially prevent relative axial movement between the expandable member and the first engaging feature.

13. The method ofclaim 11, wherein the step of providing an insertion apparatus includes providing an insertion apparatus further including an operation member operatively connected to at least one of the first and second arms for controlling relative axial movement between the first and second arms.

14. The method ofclaim 13, wherein the step of effectuating relative movement between the first and second arms includes manipulating the operation member to cause approximation of the first engaging feature and the second engaging feature and distal advancement of the dilation member.

15. A kit for providing access to a surgical site within tissue, the kit comprising:

an expandable member insertable into an opening in the tissue;

an expansion assembly removably positionable with the expandable member to enlarge the opening; and

an insertion apparatus comprising:

a first arm configured and dimensioned to receive the expandable member such that axial movement of the expandable member is restricted with respect to the tissue following insertion of the expandable member to thereby minimize trauma upon repositioning of the dilation member; and

a second arm operatively connected to the first arm, the second arm being configured and dimensioned to receive the expansion assembly to establish and maintain relative axial alignment between the expandable member and the expansion assembly.

16. The kit ofclaim 15, wherein the expandable member includes a radially expandable sleeve with a lumen extending therethrough that is configured and dimensioned to receive the dilation member.

17. The kit ofclaim 16, wherein the sleeve of the expandable member includes a tubular braid formed from an inelastic material.

18. The kit ofclaim 15, further including a needle for use in creating the opening in the tissue.

19. The kit ofclaim 18, wherein the expandable member is configured and dimensioned to receive the needle.

20. The kit ofclaim 15, wherein the expansion assembly includes a tubular member defining a lumen therethrough and an obturator with a distal end configured and dimensioned to separate tissue, the obturator being removably positionable within the lumen of the tubular member to facilitate distal advancement of the tubular member.

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