US20090093752A1 - Seal anchor for use in surgical procedures - Google Patents

Abstract

A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition to facilitate securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract and a second compressed condition to facilitate at least partial insertion of the seal anchor member within the tissue tract. The seal anchor member defines a longitudinal axis, and has leading and trailing ends with at least one longitudinal port extending therebetween adapted for reception of an object whereby compressible material defining the at least one port is adapted to deform to establish a substantial sealed relation with the object. The seal anchor member may comprise a memory foam material and may include a plurality of longitudinal ports.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/075,867 filed on Jun. 26, 2008, entitled SEAL ANCHOR FOR USE IN SURGICAL PROCEDURES, and U.S. Provisional Application Ser. No. 60/997,885 filed on Oct. 5, 2007, entitled SEAL ANCHOR FOR USE IN SINGLE INCISION SURGERY, the entire contents of which are incorporated herein by reference.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to a seal for use in a surgical procedure. More particularly, the present disclosure relates to a seal anchor member adapted for insertion into an incision in tissue, and, for the sealed reception of one or more surgical objects such that a substantially fluid-tight seal is formed with both the tissue and the surgical object, or objects.
• 2. Background of the Related Art
• Today, many surgical procedures are performed through small incisions in the skin, as compared to the larger incisions typically required in traditional procedures, in an effort to reduce both trauma to the patient and recovery time. Generally, such procedures are referred to as “endoscopic”, unless performed on the patient's abdomen, in which case the procedure is referred to as “laparoscopic”. Throughout the present disclosure, the term “minimally invasive” should be understood to encompass both endoscopic and laparoscopic procedures.
• During a typical minimally invasive procedure, surgical objects, such as surgical access devices, e.g., trocar and cannula assemblies, or endoscopes, are inserted into the patient's body through the incision in tissue. In general, prior to the introduction of the surgical object into the patient's body, insufflation gasses are used to enlarge the area surrounding the target surgical site to create a larger, more accessible work area. Accordingly, the maintenance of a substantially fluid-tight seal is desirable so as to prevent the escape of the insufflation gases and the deflation or collapse of the enlarged surgical site.
• To this end, various valves and seals are used during the course of minimally invasive procedures and are widely known in the art. However, a continuing need exists for a seal anchor member that can be inserted directly into the incision in tissue and that can accommodate a variety of surgical objects while maintaining the integrity of an insufflated workspace.
SUMMARY
• These and other features of the apparatus disclosed herein will become more readily apparent to those skilled in the art from the following detailed description of various embodiments of the present disclosure. Accordingly, a surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition to facilitate securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract and a second compressed condition to facilitate at least partial insertion of the seal anchor member within the tissue tract. The seal anchor member defines a longitudinal axis, and has leading and trailing ends with at least one longitudinal port extending therebetween.
• At least one of the leading and trailing ends of the seal anchor member exhibits an arcuate configuration, which may be either concave or convex. In one embodiment, each of the leading and trailing ends exhibit such an arcuate configuration to facilitate insertion of the seal anchor member within the tissue tract.
• The at least one longitudinal port may include a plurality of longitudinal ports which may be configured symmetrically with respect to the longitudinal axis, spaced equidistant from the longitudinal axis, spaced equally from one another, or any combination thereof.
• The seal anchor member may be formed of a foam material, which may be at least partially constituted of a material selected from the group consisting of polyisoprene, urethane, and silicone. Alternatively, the seal anchor member may be formed of a gel material.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
• FIG. 1 is a front perspective view of a surgical apparatus in accordance with the principles of the present disclosure shown in an expanded condition illustrating a seal anchor member positioned relative to the tissue;
• FIG. 2 is a cross-sectional view of the seal anchor member ofFIG. 1 taken along line2-2 ofFIG. 1 illustrating a port that extends longitudinally therethrough;
• FIG. 3 is a view of the port ofFIG. 2 with a surgical object inserted therethrough;
• FIG. 4 is a perspective view of the seal anchor member ofFIG. 1 shown in a compressed condition and prior to the insertion thereof into an incision in tissue;
• FIG. 5 is a front perspective view of the seal anchor member shown in the expanded condition and subsequent to its insertion into the incision;
• FIG. 6 is an exploded perspective view of an exemplary cannula for insertion within the longitudinal extending port of the seal anchor member;
• FIG. 7 is a front perspective view of an alternate embodiment of the surgical apparatus ofFIG. 1 illustrating a seal anchor member and an inflatable fluid membrane;
• FIG. 7A is a front perspective view of the fluid port of the fluid membrane;
• FIG. 7B is a front perspective view of the fluid port ofFIG. 7A with the valve in an open position; and
• FIG. 8 is a front perspective view of the seal anchor member of the surgical apparatus of in compressed condition prior to the insertion within the incision.
• FIG. 9 is a top perspective view of an alternate embodiment of the seal anchor member ofFIG. 1 having concave proximal and distal portions;
• FIG. 10 is a side view of the seal anchor member ofFIG. 9;
• FIG. 11 is a top view of the seal anchor member ofFIG. 9;
• FIG. 12 is a cross-sectional view of the seal anchor member ofFIG. 9 taken along line12-12 ofFIG. 11 illustrating a port that extends longitudinally therethrough;
• FIG. 13 is a cross-sectional view of the seal anchor member ofFIG. 9 taken along line13-13 ofFIG. 10;
• FIG. 14 is a front perspective view of another embodiment of the seal anchor member ofFIG. 1 having convex proximal and distal portions;
• FIG. 15 is a top, perspective view of yet another embodiment of the seal anchor member ofFIG. 1 shown in an expanded condition with a surgical object inserted into one of the ports extending longitudinally therethrough;
• FIG. 16 is a perspective, cross-sectional view of the seal anchor member ofFIG. 15 taken along line16-16;
• FIG. 17 is a top, perspective view of still another embodiment of the seal anchor member ofFIG. 1 shown in an expanded condition with a surgical object inserted into one of the ports extending longitudinally therethrough;
• FIG. 18 is a perspective, cross-sectional view of the seal anchor member ofFIG. 17 taken along line18-18;
• FIG. 19 is a top view of an alternate embodiment of the seal anchor member seen inFIG. 1 including an ingress port and an egress port each extending longitudinally therethrough;
• FIG. 20 is a side, cross-sectional view of the seal anchor member ofFIG. 19 positioned within a patient's tissue;
• FIG. 21 is a side, perspective view of a tube assembly for insertion into the ingress port of one embodiment of the seal anchor member ofFIG. 19;
• FIG. 22 illustrates a first kit in accordance with the principles of the present disclosure including the seal anchor member ofFIG. 19 and a plurality of obturators positionable within a plurality of cannulae;
• FIG. 23 illustrates an alternate embodiment of the kit ofFIG. 22;
• FIG. 24 illustrates another alternate embodiment of the surgical kit including a seal anchor member and an insufflation/evacuation implement;
• FIG. 25 is a top plan view of the seal anchor member and the insufflation/evacuation implement of the surgical kit ofFIG. 24;
• FIG. 26 is a side cross-sectional view of the seal anchor member and the insufflation/evacuation implement taken along the lines26-26 ofFIG. 25;
• FIG. 27 illustrates additional instrumentation incorporated within the surgical kit ofFIGS. 24-26; and
• FIGS. 28A-28C illustrate a method of use of the surgical kit ofFIGS. 24-27.
DETAILED DESCRIPTION OF THE EMBODIMENTS
• In the drawings and in the description which follows, in which like references numerals identify similar or identical elements, the term “proximal” will refer to the end of the apparatus which is closest to the clinician during use, while the term “distal” will refer to the end which is furthest from the clinician, as is traditional and known in the art.
• With reference toFIGS. 1-3, asurgical apparatus10 for use in a surgical procedure, e.g., a minimally invasive procedure is illustrated.Surgical apparatus10 includesseal anchor member100 defining a longitudinal axis “A” and having respective trailing (or proximal) and leading (or distal) ends102,104 and anintermediate portion106 disposed between the trailing and leading ends102,104.Seal anchor member100 includes one ormore ports108 that extend longitudinally between trailing and leading ends102,104, respectively, and throughseal anchor member100.
• Seal anchor member100 is preferably formed from a suitable foam material having sufficient compliance to form a seal about one or more surgical objects, shown generally as surgical object “I” (FIG. 3), and also establish a sealing relation with the tissue. The foam is preferably sufficiently compliant to accommodate off axis motion of the surgical object “I”. In one embodiment, the foam includes a polyisoprene material.
• Proximal end102 of seal anchor member defines a first diameter D₁anddistal end104 defines a second diameter D₂. In one embodiment ofseal anchor member100, the respective first and second diameters D₁, D₂of the proximal anddistal ends102,104 are substantially equivalent, as seen inFIG. 1, although an embodiment ofseal anchor member100 in which diameters D₁, D₂are different is also within the scope of the present disclosure. As depicted inFIG. 1, proximal anddistal ends102,104 define substantially planar surfaces. However, embodiments are also contemplated herein in which either or both of proximal anddistal ends102,104, respectively, define surfaces that are substantially arcuate to assist in the insertion ofseal anchor member100 within atissue tract12 defined bytissue surfaces14 and formed in tissue “T”, e.g., an incision, as discussed in further detail below.
• Intermediate portion106 defines a radial dimension “R” and extends longitudinally between proximal anddistal ends102,104, respectively, to define an axial dimension or length “L”. The radial dimension “R” ofintermediate portion106 varies along the axial dimension, or length, “L” thereof. Accordingly,seal anchor member100 defines a cross-sectional dimension that varies along its length “L”, which facilitates the anchoring ofseal anchor member100 within tissue “T”, as discussed in further detail below. However, an embodiment ofseal anchor member100 in which the radial dimension “R” remains substantially uniform along the axial dimension “L” thereof is also within the scope of the present disclosure.
• The radial dimension “R” ofintermediate portion106 is appreciably less than the respective diameters D₁, D₂of proximal anddistal ends102,104 such thatseal anchor member100 defines an “hour-glass” shape or configuration to assist in anchoringseal anchor member100 within tissue “T”, as discussed in further detail below. However, in an alternate embodiment, the radial dimension “R” ofintermediate portion106 may be substantially equivalent to the respective diameters D₁, D₂of proximal anddistal ends102,104. In cross section,intermediate portion106 may exhibit any suitable configuration, e.g., substantially circular, oval or oblong.
• Eachport108 is configured to removably receive the surgical object “I”. Prior to the insertion of surgical object “I”,port108 is in a first state in whichport108 defines a first or initial dimension D_P1. D_P1will generally be about 0 mm such that the escape of insufflation gas (not shown) throughport108 ofseal anchor member100 in the absence of surgical object “I” is substantially prevented. For example,port108 may be a slit extending the longitudinal length ofseal anchor member100 through proximal anddistal ends102,104. In the alternative,port108 may define an opening withinseal anchor member100 having an initial open state. Upon the introduction of surgical object “I”,port108 transitions to a second state in whichport108 defines a second, larger dimension D_P2that substantially approximates the diameter D_Iof surgical object “I” such that a substantially fluid-tight seal is formed therewith, thereby substantially preventing the escape of insufflation gas (not shown) throughport108 ofseal anchor member100 in the presence of surgical object “I”. D_I, and thus D_P2, will generally lie within the range of about 5 mm to about 12 mm, as these dimensions are typical of the surgical objects used during the course of minimally invasive procedures. However, aseal anchor member100 including aport108 that is capable of exhibiting substantially larger, or smaller, dimensions in the second state thereof is not beyond the scope of the present disclosure. In addition,seal anchor100 may be devoid ofports108. With this arrangement,ports108 are created withinseal anchor member100 during the insertion of the surgical object “I”. In accordance with this embodiment,seal anchor member100 is formed of a flowable or sufficiently compliable material such as a foam material, e.g., an open-cell polyurethane foam, a thermoplastic elastomer (TPE) or a gel. The formation ofseal anchor member100 may involve a process whereby an inert gas, such as CO2 or nitrogen is infused into the material so as to form a foam structure.Seal anchor member100 may also be coated with lubricious coating, e.g., Parylene N or C in order to ease insertion of instruments and/or cannulas therethrough.
• Referring now toFIGS. 1 and 4,seal anchor member100 is adapted to transition from an expanded condition (FIG. 1) to a compressed condition (FIG. 4) so as to facilitate the insertion and securement thereof withintissue tract12 in tissue “T”. In the expanded condition,seal anchor member100 is at rest and the respective radial dimensions D₁, D₂of the proximal anddistal ends102,104 ofseal anchor member100, as well as the radial dimension R of theintermediate portion106 are such that theseal anchor member100 cannot be inserted withintissue tract12. However, as seen inFIG. 4, in the compressed condition, proximal anddistal ends102,104 ofseal anchor member100, as well asintermediate portion106 are dimensioned for insertion intotissue tract12.
• Seal anchor member100 is formed of a biocompatible compressible material that facilitates the resilient, reciprocal transitioning ofseal anchor member100 between the expanded and compressed conditions thereof. In one embodiment, the compressible material is a “memory” foam. An external force “F” is applied to sealanchor member100 to cause theseal anchor member100 to assume the compressed condition. External force “F” is directed inwardly and whenseal anchor member100 is subjected thereto, e.g., whenseal anchor member100 is squeezed,seal anchor member100 undergoes an appreciable measure of deformation, thereby transitioning into the compressed condition.
• As depicted inFIG. 4, asseal anchor member100 is compressed under the influence of external force “F”, an internal biasing force “F_B1” is created withinseal anchor member100 that is directed outwardly, opposing force “F”. Internal biasing force “F_B1” endeavors to expandseal anchor member100 and thereby returnseal anchor member100 to the expanded condition thereof. Accordingly, as long asseal anchor member100 is subject to external force “F”,seal anchor member100 remains in the compressed condition. Upon the removal of external force “F”, however, biasing force “F_B1” acts to returnseal anchor member100 to the expanded condition.
• The compressible material comprisingseal anchor member100 also facilitates the resilient transitioning ofport108 between its first closed state (FIGS. 1-2) and its second state (FIG. 3). As previously discussed, prior to the insertion of surgical object “I”,port108 is in its first state in whichport108 defines a first or initial dimension D_P1. Port108 may incorporate a slit extending the longitudinal length ofseal anchor member100. In this first state,port108 is at rest and is not subject to any external forces. However, upon the introduction of surgical object “I” throughport108 as depicted inFIG. 3, the surgical object “I” exerts a force “F_I” uponport108 that is directed radially outward. Force “F_I” acts to enlarge the dimensions ofport108 and therebytransition port108 into the second state thereof in whichport108 defines a second, larger dimension D_P2that substantially approximates the diameter D_Iof surgical object “I”. Consequently, an internal biasing force “F_B2” is created that is directed radially inward, in opposition to force “F_I”. Internal biasing force “F_B2” endeavors to returnport108 to reduce the internal dimension ofport108 and thereby returnport108 to the first state thereof. Internal biasing force “F_B2” is exerted upon surgical object “I” and acts to create a substantially fluid-tight seal therewith. The significance of forces “F_B1” and “F_B2” will be discussed in further detail below.
• Referring again toFIG. 1, one ormore positioning members114 may be associated with either or both of trailing (or proximal)end102 and distal (or leading)end104 ofseal anchor member100. Positioningmembers114 may be composed of any suitable biocompatible material that is at least semi-resilient such thatpositioning members114 may be resiliently deformed and may exhibit any suitable configuration, e.g., substantially annular or oval. Prior to the insertion ofseal anchor member100, positioningmembers114 are deformed in conjunction with the respective proximal anddistal ends102,104 ofseal anchor member100 to facilitate the advancement thereof through tissue tract12 (FIG. 4). Subsequent to the insertion ofseal anchor member100 withintissue tract12, the resilient nature ofpositioning members114 allows positioning members to return to their normal, substantially annular configuration, thereby aiding in the expansion of either or both of the respective proximal anddistal ends102,104 and facilitating the transition ofseal anchor member100 from its compressed condition to its expanded condition. Positioningmembers114 also may engage the walls defining the body cavity to further facilitate securement ofseal anchor member100 within the body tissue. For example,positioning member114 at leadingend104 may engage the internal peritoneal wall andpositioning member114 adjacent trailingend102 may engage the outer epidermal tissue adjacent theincision12 within tissue “T”. In another embodiment ofseal anchor member100, one or moreadditional positioning members114 may be associated withintermediate portion106.
• The use and function ofseal anchor member100 will be discussed during the course of a typical minimally invasive procedure. Initially, the peritoneal cavity (not shown) is insufflated with a suitable biocompatible gas such as, e.g., CO₂gas, such that the cavity wall is raised and lifted away from the internal organs and tissue housed therein, providing greater access thereto. The insufflation may be performed with an insufflation needle or similar device, as is conventional in the art. Either prior or subsequent to insufflation, atissue tract12 is created in tissue “T”, the dimensions of which may be varied dependent upon the nature of the procedure.
• Prior to the insertion ofseal anchor member100 withintissue tract12,seal anchor member100 is in its expanded condition in which the dimensions thereof prohibit the insertion ofseal anchor member100 intotissue tract12. To facilitate insertion, the clinician transitions sealanchor member100 into the compressed condition by applying a force “F” thereto, e.g., by squeezingseal anchor member100. Force “F” acts to reduce the radial dimensions of the proximal anddistal ends102,104, respectively, to D₁′ and D₂′ (FIG. 4) including positioning members114 (if provided) and to reduce the radial dimension ofintermediate portion106 to R′ such thatseal anchor member100 may be inserted intotissue tract12. As best depicted inFIG. 5, subsequent to its insertion,distal end104, positioning member114 (if provided) and at least asection112 ofintermediate portion106 are disposed beneath the tissue “T”.Seal anchor member100 is caused to transition from the compressed condition to the expanded condition by removing force “F” therefrom.
• During the transition from the compressed condition to the expanded condition, the dimensions ofseal anchor member100, i.e., the respective radial dimensions D₁′, D₂′ (FIG. 4) of the proximal anddistal ends102,104 are increased to D₁and D₂(FIG. 5) and the radial dimension R′ is increased to R. The expansion ofdistal end104 is relatively uninhibited given the disposition thereof beneath tissue “T”, and accordingly,distal end104 is permitted to expand substantially, if not completely. However, as seen inFIG. 5, the expansion of thesection112 of theintermediate portion106 is limited by the tissue surfaces14 (FIG. 1) definingtissue tract12, thereby subjectingintermediate portion106 to an external force “F” that is directed inwardly. As discussed above, this creates an internal biasing force “F_B1” that is directed outwardly and exerted upon tissue surfaces14, thereby creating a substantially fluid-tight seal between theseal anchor member100 and tissue surfaces14 and substantially preventing the escape of insufflation gas aroundseal anchor member100 and throughtissue tract12.
• In the expanded condition, the respective radial dimensions D₁, D₂of the proximal anddistal ends102,104 are substantially larger than the radial dimension R of theintermediate portion106 thereby givingseal anchor member100 the aforedescribed “hour-glass” configuration. Subsequent to insertion, the radial dimension D₂ofdistal end104 andpositioning member114 is also substantially larger than the dimensions of thetissue tract12. Consequently,seal anchor member100 may not be removed fromtissue tract12 in the expanded condition and thus,seal anchor member100 will remain anchored within the tissue “T” until it is returned to its compressed condition.
• After successfully anchoringseal anchor member100 within the patient's tissue “T”, one or more surgical objects “I” may be inserted throughports108.FIG. 5 illustrates a surgical object “I” introduced through one ofports108. As previously discussed, prior to the insertion of surgical object “I”,port108 is in its first state in whichport108 defines an initial dimension D_P1which may be negligible in thatport108, in one embodiment, is a longitudinal slit. Accordingly, prior to the escape of insufflation gas throughport108, in the absence of surgical object “I” is minimal, thereby preserving the integrity of the insufflated workspace.
• Surgical object “I” may be any suitable surgical instrument and, accordingly, may vary in size. Suitable surgical objects to be introduced within one or more of theports108 include minimally invasive grasper instruments, forceps, clip-appliers, staplers, etc. It is further contemplated that the surgical objects may include aconventional cannula1000 as depicted inFIG. 6.Cannula1000 is configured for removable insertion intoport108 and includes respective proximal anddistal ends1002,1004, a shaft orelongate member1006 disposed therebetween and sealhousing1008.Elongate member1006 defines anopening1010 extending longitudinally therethrough that is dimensioned to permit the passage of surgical instrumentation (not shown), such as an obturator. Disposed withinseal housing1008 is an instrument seal1012 that is adapted to receive the surgical instrumentation inserted intolongitudinal opening1010 so as to form a substantially fluid-tight seal therewith.Cannula1000 further includes aclosure valve1014 that is biased into a closed position, but is adapted to open upon the introduction of the surgical instrumentation inserted intolongitudinal opening1010 to allow the surgical instrumentation to pass therethrough. In the closed position, i.e., in the absence of surgical instrumentation,closure valve1014 prevents the communication of insufflation gas therethrough.
• Upon the introduction of surgical object “I”, e.g.,cannula1000,port108 is enlarged, thereby transitioning into its second state in whichport108 defines a second dimension D_P2(FIG. 3) that substantially approximates the diameter D_Iof surgical object “I”, thereby creating a substantially fluid tight seal with surgical object “I” and substantially preventing the escape of insufflation gas (not shown) throughport108 ofseal anchor member100 in the presence of a surgical object “I”, as previously discussed.
• Referring now toFIGS. 7-8, an alternate embodiment of aseal anchor member200 is disclosed.Seal anchor member200 comprises a resilient conformable material such as foam or, alternatively, a gel.Seal anchor member200, proximal anddistal ends202,204, and anintermediate portion206 disposed therebetween.Seal anchor member200 further includesexpandable membrane208 defininginternal cavity210.Membrane208 may be, e.g., substantially annular or donut-shaped in configuration, although any conceivable shape may be employed, and may be secured, attached or embedded to or within the foam or gel material ofseal anchor member200. In one embodiment,membrane208 surrounds foam orgel segment212 thereby defining the periphery ofseal anchor member200. One or morefluid ports214 are in communication withinternal cavity210 ofmembrane208 and one or morelongitudinal ports216 that extend throughfoam segment212 ofseal anchor member200.
• Internal cavity210 defined bymembrane208 is configured to retain a fluid therein.Membrane208 may be formed of any suitable biocompatible that is sufficiently resilient to allow the flow of fluid into and out ofinternal cavity210 to cause the expansion and contraction thereof. In addition, thematerial comprising membrane208 is substantially impermeable with respect to the fluid to ensure that the flow of fluid into and out of internal cavity occurs solely throughfluid port214.
• Fluid port214 is adapted for connection to afluid source218.Fluid port214 may be any member or structure suitable for this intended purpose. Although depicted as including asingle fluid port214, in alternate embodiments,seal anchor member200 may include additional fluid ports, e.g., on each of proximal anddistal ends202,204, respectively.Fluid port214 may also include avalve220 that is selectively positionable between an open position (FIG. 7A) and a closed position (FIG. 7B) to regulate the flow of fluid into and out ofinternal cavity210 throughfluid port214.
• As withseal anchor member100 discussed above with respect toFIGS. 1-6,seal anchor member200 is adapted to transition from an expanded condition (FIG. 7) to a compressed condition (FIG. 8). In the compressed condition (FIG. 8),seal anchor member200 is configured for insertion withintissue tract12 in tissue “T”, in a similar manner, as discussed above with respect to seal anchor member100 (FIGS. 1-5).Seal anchor member200 is positioned within tissue “T” wherebyfoam segment212 of theseal anchor member200 and assumes the expanded condition.Fluid port214 may be connected to fluid source216 (FIG. 7) and fluid is communicated into theinternal cavity210 defined bymembrane208. Asinternal cavity210 fills with fluid, the dimensions ofinternal cavity210 andmembrane208 are enlarged, thereby forcing the outer surface ofseal anchor member200 outwardly and establishing a seal within the incision “I”.
• With reference now toFIGS. 9-13, another embodiment of aseal anchor member300 is disclosed.Seal anchor member300 extends along a longitudinal axis “A” that passes through a centerpoint “C” thereof.Seal anchor member300 defines an overall axial dimension “H” measured along the longitudinal axis “A”. The overall axial dimension “H” will generally lay substantially within the range of approximately 25 mm to approximately 75 mm, and desirably, is approximately equal to 50 mm. However, the present disclosure also contemplates aseal anchor member300 that defines either a substantially larger or smaller overall axial dimension “H”.
• As with each of the previous embodiments, the material comprisingseal anchor member300 is sufficiently compliant to accommodate off-axis movement of the surgical object, or objects, “I” inserted therethrough that may be necessitated during the course of the minimally invasive surgical procedure in whichseal anchor member300 is employed. In one embodiment,seal anchor member300 is formed from a suitable foam material, which may be at least partially constituted of polyisoprene, urethane, or silicone, or the like. Alternatively,seal anchor member300 may be formed of a biocompatible gel material.
• As with the previous embodiments,seal anchor member300 includes respective trailing (or proximal) and leading (or distal) ends302,304, anintermediate portion306 disposed therebetween, and one ormore ports308 that extend longitudinally between the respective trailing and leading ends302,304 and throughseal anchor member300.
• Proximal end302 ofseal anchor member300 defines a first radial dimension D₁and a first axial dimension H₁, anddistal end304 defines a second radial dimension D₂and a second axial dimension H₂. The present disclosure contemplates aseal anchor member300 having proximal anddistal ends302,304 that define radial dimensions D₁, D₂generally laying substantially within the range of approximately 25 mm to approximately 75 mm, and axial dimensions H₁, H₂generally laying substantially within the range of approximately 6 mm to approximately 11 mm, respectively. Desirably, however,seal anchor member300 includes proximal anddistal ends302,304 having radial dimensions D₁, D₂that are approximately equal to 50 mm and axial dimensions H₁, H₂that are approximately equal to 8.5 mm, respectively. Aseal anchor member300 having proximal anddistal ends102,104 that define substantially larger or smaller radial and axial dimensions is also within the scope of the present disclosure.
• In the embodiment illustrated inFIGS. 9-13,seal anchor member300 includes respective proximal anddistal ends302,304 having respective first and second radial dimensions D₁, D₂that are substantially equivalent. However, an embodiment ofseal anchor member300 that includes respective proximal anddistal ends302,304 having respective first and second radial dimensions D₁, D₂that differ is also contemplated herein.
• Intermediate portion306 ofseal member300 defines a radial dimensions “R” generally laying substantially within the range of approximately 20 mm to approximately 50 mm, and an axial dimension “L” generally laying substantially within the range of approximately 10 mm to approximately 40 mm. While it is desirable for the radial and axial dimensions “R”, “L” ofintermediate portion306 to be approximately equal to 35 mm and 25 mm, respectively, aseal anchor member300 having anintermediate portion306 that defines substantially larger or smaller radial and axial dimensions is not beyond the scope of the present disclosure. The radial dimension “R” ofintermediate portion306 may be substantially uniform or variable along the axial dimension “L” thereof, and may be appreciably less than, greater than, or equal to the respective radial dimensions D₁, D₂of proximal anddistal ends302,304, as discussed above.
• As with each of the previous embodiments, the port, or ports,308 are configured to removably receive a surgical object “I” (not show), and prior to the insertion of surgical object “I”, eachport308 defines an initial dimension D_P1. D_P1will generally lie substantially within the range of approximately 0 mm to approximately 13 mm, and desirably, is approximately equal to 6.5 mm. However, aseal anchor member300 having aport308 that defines a substantially greater initial dimension D_P1is not beyond the scope of the present disclosure. In those embodiments ofseal member300 employing aport308 that defines an initial dimension D_P1approximately equal to 0 mm, the escape of insufflation gas (not shown) therethrough may be substantially prevented in the absence of surgical object “I”.
• Seal anchor member300 may include a plurality ofports308 that are symmetrically arranged with respect to the longitudinal axis “A”. It is further contemplated that eachport308 may be spaced equidistant from the longitudinal axis “A”. In one embodiment, eachport308 is spaced a distance “D” from the longitudinal axis “A” generally laying substantially within the range of approximately 6 mm to approximately 11 mm, and desirably, approximately equal to 8.5 mm. However, in alternate embodiments,seal anchor member300 may includeports308 spaced either a larger or smaller distance from the longitudinal axis “A”.Ports308 may be arranged such that they are spaced equally from one another, or alternatively, the distance betweenadjacent ports308 may vary.
• Either or both of the respective proximal anddistal ends302,304 ofseal anchor member300 define surfaces that are substantially arcuate, e.g., concave, as seen inFIGS. 9-13, to facilitate insertion ofseal anchor member300 within a tissue tract12 (FIG. 1) defined bytissue surfaces14 and formed in tissue “T”, e.g., an incision, as discussed above. The concave orientation may, e.g., assist in guiding a surgical instrument toward one ofports308 and also confine the tip of the instrument within the outer boundary of theproximal end302 ofseal anchor member300. In the alternative, either or both of proximal anddistal ends302,304 may be convex as seen inFIG. 14.
• Referring now toFIGS. 15-16, another embodiment ofseal anchor member400 is disclosed.Seal anchor member400 includes respective proximal anddistal ends402,404, anintermediate portion406 disposed between the proximal anddistal ends402,404, and one or more generallytubular port segments408 definingports408athat extend longitudinally throughseal anchor member400 and between the proximal anddistal ends402,404. Theseal anchor member400 is substantially similar to theseal anchor100 illustrated inFIGS. 1-5, and accordingly, will only be discussed with respect to its differences.
• In one embodiment, as seen inFIGS. 15-16,seal anchor member400 defines corresponding proximal anddistal rims410,412, respectively. The proximal anddistal rims410,412 facilitate deformation ofseal anchor member400 from the expanded condition (FIGS. 15-16) to the compressed condition (not shown) and the anchoring ofseal anchor member400 within tissue, as previously discussed with respect to theseal anchor member100 illustrated inFIGS. 1-5.
• Tubular port segments408 are secured to theintermediate portion406 by aconnective member414 such that the longitudinal position of theport segments408 remain substantially constant with respect to the respective proximal anddistal rims410,412 during insertion and removal of the surgical object “I”. In the embodiment illustrated inFIGS. 15-16, theconnective member414 extends inwardly from theintermediate portion406 and is attached toports408 at midpoints “M” thereof that are spaced equidistant from the respective proximal anddistal rims410,412. In various embodiments, theconnective member414 may be composed of the same material comprising theseal anchor member400, or alternatively, theconnective member414 may be composed of a material that is substantially more rigid, to inhibit off-axis movement of the surgical object “I” following its insertion into one of theports408, or substantially less rigid, to facilitate off-axis movement of the surgical object “I”.
• In the embodiment illustrated inFIGS. 15-16, theports408 extend longitudinally along the longitudinal axis “A” defined by theseal anchor member400 such that aproximal end416 of theports408 is coplanar with theproximal rim402 and adistal end418 of theports408 is coplanar with thedistal rim404. However, embodiments in which the proximal anddistal ends416,418 ofports408 extend beyond the proximal anddistal rims402,404, respectively, such that they extend at least partially from theintermediate portion406, and embodiments in which the proximal anddistal ends416,418 ofports408 are defined entirely within theintermediate portion406 are also contemplated herein.
• Referring now toFIGS. 17-18, in an alternate embodiment, theconnective member414 extends inwardly from thedistal rim412 and is attached toports408 at the distal ends418 thereof. To further limit off-axis movement of the surgical object “I” upon insertion, theconnective member414 may extend substantially along the length of theports408, as illustrated. Either or both of the respective proximal anddistal ends416,418 of theports408 may be beveled, e.g., to facilitate the insertion and removal of the surgical object “I”.
• FIGS. 19-20 illustrate an alternate embodiment of the seal anchor member, referred to generally byreference number500. Theseal anchor member500 is substantially similar to theseal anchor member300 discussed above with respect toFIGS. 9-14, and accordingly, will only be discussed with respect to its differences therefrom.
• Theseal anchor member500 includes aningress port502 and anegress port504 extending longitudinally through theseal anchor member500. Theingress port502 facilitates the communication of a fluid through theseal anchor member500 and into a surgical worksite “W” located beneath the patient's tissue “T”. In one embodiment, theingress port502 is configured and dimensioned to removably receive a tube assembly600 (FIG. 21) to facilitate insufflation of the surgical worksite “W”. In contrast, theegress port504 facilitates the communication of a fluid, such as smoke, through theseal anchor member500 and out of the surgical worksite “W”. To substantially limit the communication of fluid into and out of the surgical worksite “W”, the ingress andegress ports502,504 may respectively include a one-way valve (not shown), such as a duck-bill or zero closure valve. Alternatively, theingress port502 and theegress port504 may be normally biased towards a closed condition.
• With reference now toFIGS. 22-23, kits according to the present disclosure include a seal anchor member, one or more cannulae, and one or more obturators together with instructions for use “IFU”. In one embodiment, afirst kit700_Ais disclosed that includes theseal anchor member500 discussed above with respect toFIGS. 19-20, threecannulae800_Aeach defining an outer diameter “D_A” of 5 mm, and threeobturators900_Aconfigured for removable insertion through thecannulae800_A. In another embodiment, asecond kit700_Bis disclosed that includes theseal anchor member500 discussed above with respect toFIGS. 22-23, twocannulae800_B1each defining an outer diameter “D_B1” of 5 mm, twoobturators900_B1configured for removable insertion through thecannulae800_B1, asingle cannula800_B2defining an outer diameter “D_B2” of 12 mm, and asingle obturator900_B2configured for removable insertion through thecannulae800_B2.
• The kit components will typically be maintained within sterile packaging, with individual components being packaged either together or separately in different sterile containers. Usually, even when packaged in separate sterile containers, all components of the kit will be placed together within a common package. The instructions for use “IFU” may be provided on a separate printed sheet, such as a conventional package insert, or may be printed in whole or in part on other portions of the packaging or the device itself.
• While thekits700_A,700_Bhave been described as including theseal anchor member500 and three cannulae with corresponding obturators of specific dimensions, it should be understood that kits according to the present disclosure may alternatively include any of the seal anchor members described herein above in combination with any desired number of cannulae and obturators exhibiting any suitable dimensions.
• FIGS. 24-26 illustrate another embodiment of the surgical kit.Surgical kit1000 includesseal anchor member1100 and fluid delivery, e.g., insufflation/evacuation instrument,1200 which is positionable within theseal anchor member1100.Seal anchor member1100 includes a plurality of passageways1102 (e.g., four are shown) extending through theseal anchor member1100,Passageways1102 may extend in general parallel relation with respect to the longitudinal axis “k”. In the alternative,passageways1102 may be in oblique relation with respect to the longitudinal axis “k” to provide specific directional capability to theseal anchor member1100 whereby an instrument may be advanced at a predetermined angular orientation relative to the longitudinal axis “k”.Passageways1102 may be radially spaced about theseal anchor member1100 relative to the longitudinal axis “k”. In one aspect,passageways1102 are spaced a predetermined distance sufficient to correspondingly space the instruments introduced withinseal anchor member1100. This spacing may substantially minimize the potential of engagement of the inserted instruments and enhance freedom of movement above the operative area.Passageways1102 may be longitudinal bores defined withinseal anchor member1100. Longitudinal bores may be open in an initial or at rest condition. In the alternative,passageways1102 may define slits or individual valves, e.g. zero closure valves, which are closed in the normal condition in the absence of an object inserted therethrough. In this embodiment,passageways1102 would open to permit passage of the surgical object. In either case, upon introduction of the surgical object or instrument, the interiorsurfaces defining passageways1102 establish a substantial fluid tight seal about the object.
• Seal anchor1100 defines a substantially hourglass configuration and incorporates enlarged leading and trailingflange segments1104,1106 to assist in retention within the body cavity. Leading and trailing end faces1108,1110 may be recessed as shown and/or may include any number or shape so as to provide improved compressibility ofseal anchor1100 or freedom of movement of any instruments inserted therethrough.Seal anchor1100 may be fabricated from any of the aforementioned materials including foam, gel or the like.
• Insufflation/evacuation instrument1200 is adapted for positioning within at least one of thepassageways1102. Insufflation/evacuation instrument1200 may be any suitable instrument adapted to convey fluids or introduce insufflation gases, e.g., CO2 into the peritoneal cavity, and/or evacuate smoke from the cavity. In the depicted embodiment,insufflation instrument1200 includeshousing1202 and elongatedmember1204 extending from thehousing1202.Housing1202 may be fabricated from any suitable material and incorporates astop cock valve1206 to permit selective passage and interruption of fluids, e.g., insufflation gases or smoke therethrough.Housing1202 includes first and second ports orluer connectors1208,1210 adjacentstop cock valve1204.First luer connector1208 may be adapted for connection to aninsufflation source1212 such as CO2 utilized to insufflate the peritoneal cavity.Second luer connector1210 may be adapted for fluid connection to an aspiration or gas (e.g. smoke)evacuator1214. Stopcock valve1206 may define opening1216 which is aligned with either port orluer connector1208,1210 through selective rotation of thestop cock valve1206 thereby selectively fluidly connecting theinsufflation source1212 or theevacuator1214. First andsecond luer connectors1208,1210 may be arranged about axes which are substantially perpendicular to each other. Other orientations are also envisioned.
• Elongate member1204 includes firstelongate segment1216 connected tohousing1202 and secondelongate segment1218 extending contiguously from thefirst elongate segment1216. First and secondelongate segments1216,1218 may be in general alignment with each other. In the alternative, first and secondelongate segments1216,1218 may be angulated relative to each other at a predetermined angle. In one embodiment, first and secondelongate segments1216,1218 are arranged at a substantial right angle or perpendicular with respect to each other. This arrangement may facilitate the displacement ofhousing1202 and firstelongate segment1216 from the operative area thereby reducing the overall profile ofseal anchor member1100 and insufflation/evacuator instrument1200.Elongate member1204 defines a fluid conduit extending through first and secondelongate segments1216,1218 and in communication withstop cock valve1206. First and secondelongate segments1216,1218 may be releasably mounted to each other.
• Insufflation/evacuator instrument1200 may be a separate instrument positionable within one ofpassageways1102. In the alternative,seal anchor member1100 and insufflation/evacuator instrument1100 may be pre-assembled whereby the insufflation/evacuator instrument1100 may be permanently connected to theseal anchor member1100. In one embodiment,second elongate segment1218 of insufflation/evacuator instrument1200 includesexternal anchors1220a,1220bmounted about the periphery of thesecond elongate segment1218.Anchors1220a,1220bmay facilitate retention of secondelongate segment1218 of insufflation/evacuation instrument1200 withinseal anchor member1110.Anchors1220a,1220bmay be generally annular in configuration or may consist of individual prongs depending outwardly from secondelongate segment1218.Anchors1220a,1220bare dimensioned to be embedded within the inner surfaces defining thepassageway1102 accommodating insufflation/evacuation instrument. Trailinganchor1220amay define an enlarged dimension adjacent its proximal end to resist pull out or retropulsion of insufflation/evacuator instrument1200. Leadinganchor1220bmay define an enlarged dimension adjacent its distal end to prevent over insertion of insufflation/evacuator instrument1200.
• Referring now toFIG. 27, additional instrumentation which may be incorporated withinsurgical kit1000 is illustrated.Surgical kit1000 may further include first andsecond cannulas1300,1302 and first andsecond obturators1304,1306 for respective use with the first andsecond cannulas1300,1302.First cannula1300 may be a 5 mm cannula adapted for reception of instrumentation no greater than 5 mm in diameter.First obturator1304 is positionable withinfirst cannula1300 to facilitate advancement of thefirst cannula1300 through one ofpassageways1102 ofseal anchor1100.Second cannula1302 may be a 12 mm cannula adapted for reception of instrumentation no greater than 12 mm in diameter and is advanced withinseal anchor1100 with the use of comparably dimensionedsecond obturator1306. Second anchor may incorporate a sealing mechanism such as the sealing system disclosed in commonly assigned U.S. Patent Publication No. 2007/0197972 to Racenet, the entire contents of which are hereby incorporated herein by reference.Surgical kit1000 may incorporate three or more cannulas with corresponding obturators. Any combinations of sizes of cannulas and obturators are envisioned.
• FIGS. 28A-28C disclose a method of use of surgical kit. An incision is made in the tissue, e.g., the abdominal tissue, and blunt dissection through the fascia and peritoneum is achieved through known methods. Leading flange andend face1104,1108 ofseal anchor1100 are manipulated within the incision (FIG. 28A), possibly, with the assistance of a surgical clamp1400. When appropriately positioned within incision,seal anchor1100 snugly engages the interior surfaces of the incision with leading and trailingflanges1104,1106 adjacent the abdominal lining and outer dermal tissue, respectively (FIG. 28B). Thereafter, any combinations ofcannulas1300,1302 may be introduced withinpassageways1102 ofseal anchor1100 with the use of correspondingobturators1304,1306. (FIG. 28C) Upon positioning, the obturators are removed thereby providing access through theappropriate cannula1300,1302 for passage of surgical instrumentation to perform the surgical procedure.Cannulas1300,1302 may be staggered relative to sealanchor1100 to facilitate freedom of movement above the operative area. Removal of onecannula1300,1302 and replacement with anothersized cannula1300,1302 may be readily achieved. In the event,passageways1102 ofseal anchor1100 are open in the initial condition (e.g., in the absence of an instrument), the surgeon may place a finger over the passageway upon removal of the cannula and remove the finger when introducing the second cannula within the passageway. Insufflation and/or evacuation may be continuously effected throughout the procedure with the use ofstock cock valve1204.
• Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplifications of particular embodiments. It is to be understood, therefore, that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.

Claims (19)

1. A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity, which comprises:

a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition to facilitate securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract and a second compressed condition to facilitate at least partial insertion of the seal anchor member within the tissue tract, the seal anchor member defining a longitudinal axis and having leading and trailing ends, and at least one longitudinal port extending between the leading and trailing ends and being adapted for reception of an object whereby compressible material defining the at least one port is adapted to deform to establish a substantial sealed relation with the object, at least one of the leading and trailing ends exhibit an arcuate configuration to facilitate insertion of the seal anchor member within the tissue tract.

2. The surgical apparatus according toclaim 1 wherein each of the leading and trailing ends exhibit an arcuate configuration.

3. The surgical apparatus according toclaim 1 wherein the arcuate configuration is concave.

4. The surgical apparatus according toclaim 1 wherein the arcuate configuration is convex.

5. The surgical apparatus according toclaim 1 wherein the seal anchor member is formed of a foam material.

6. The surgical apparatus according toclaim 5 wherein the foam material is at least partially constituted of a material selected from the group consisting of polyisoprene, urethane, and silicone.

7. The surgical apparatus according toclaim 1 wherein the seal anchor member is formed of a gel material.

8. The surgical apparatus according toclaim 1 wherein the at least one longitudinal port includes a plurality of longitudinal ports.

9. The surgical apparatus according toclaim 8 wherein the plurality of longitudinal ports are configured symmetrically with respect to the longitudinal axis.

10. The surgical apparatus according toclaim 8 wherein the plurality of longitudinal ports are spaced equidistant from the longitudinal axis.

11. The surgical apparatus according toclaim 8 wherein the plurality of longitudinal ports are spaced equally from one another.

12. The surgical apparatus according toclaim 8, wherein the seal anchor member includes a plurality of generally tubular port segments, the port segments defining respective longitudinal ports.

13. The surgical apparatus according toclaim 8 including a fluid conveying instrument positioned within one of the longitudinal ports to permit conveyance of fluid to or from the operative site.

14. The surgical apparatus according toclaim 13 wherein the fluid conveying instrument is adapted to at least one of introduce insufflation gases to an underlying body cavity and evacuate gases from the underlying cavity.

15. The surgical apparatus according toclaim 15 wherein the fluid conveying instrument includes a stop cock valve.

16. The surgical access apparatus according toclaim 15 wherein the stop cock valve includes first and second ports for fluid coupling to an insufflation instrument and an evacuator, the stock cock valve further defining an opening, the stop cock valve being selectively movable to align the opening with either of the first and second ports.

17. The surgical apparatus according toclaim 13 wherein the fluid conveying instrument includes a peripheral anchor, the anchor dimensioned to facilitate retention of the fluid conveying instrument within the one of the longitudinal ports through engagement with the seal anchor.

18. The surgical apparatus according toclaim 8 including at least one cannula, the cannula positionable within one of the longitudinal ports of the seal anchor member.

19. The surgical apparatus according toclaim 18 including a plurality of cannulas, each cannula positionable within one of the longitudinal ports of the seal anchor member.

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