US20050020884A1 - Surgical access system - Google Patents

Abstract

The invention is directed to a hand access system that provides hand access to a surgical area while maintaining pneumoperitoneum during laparoscopic surgery. The hand access system comprises a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor includes a first ring being adapted for disposition interiorly of the wound, a second ring being adapted for disposition exteriorly of the wound, and a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound. The hand access system further comprises a detachable hand seal adapted to be removable from the second ring of the sheath retractor. The sheath retractor may be formed of an elastomeric material, and the hand seal may be formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of the instrument or hand. In another aspect, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a valve including a plurality of overlapping sheets defining an access channel, and a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter, the access channel extends into communication with the incision in the patient. Each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring, which provide open edges defining the access channel. The open edges slightly overlap at the center of the ring. The open edges may have different shapes including at least one of a straight edge, concave, convex and a cross-configuration. The hand access device may further comprise a septum seal formed at the proximal and distal ends of the ring.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This is a continuation application claiming the priority of (1) PCT application Serial No. PCT/US2004/005484, entitled “Sealed Surgical Access Device,” filed on Feb. 25, 2004, (2) PCT application Serial No. PCT/US2004/0054-87, entitled “Wound Retractor for Use in Hand-Assisted Laparoscopic Surgery,” filed on Feb. 25, 2004, and (3) PCT application Serial No. PCT/US2004/005361, entitled “Apparatus and Method for Illuminating a Peritoneal Cavity During Laparoscopic Surgery,” filed on Feb. 24, 2004, all of which claim priority to (4) provisional application Ser. No. 60/449,857, filed on Feb. 25, 2003, entitled “Hand-Assisted Laparoscopy Apparatus and Method,” all of which are fully incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention generally relates to surgical access systems that facilitate sealed access across a body wall and into a body cavity during a laparoscopic surgical procedure.
• 2. Discussion of the Relevant Art
• During laparoscopic surgery, it is desirable to inflate the abdominal cavity in order to increase the volume of the working space. This is accomplished with an insufflation gas which must be maintained at a pressure sufficient to inflate the abdomen. Maintaining the pressure of the insulation gas is difficult when it is also desirable to insert instrumentation through the abdominal wall. If a surgeon is interested in inserting his or her hand in a hand-assisted laparoscopic procedure, the maintenance of insulation pressure is even more difficult. Currently, several devices exist that accomplish this surgical need although they suffer from drawbacks such as difficult placement and cumbersome use. For example, these hand-assisted devices require elaborate mechanisms such as inflatable cuffs and adhesives to seal around a surgeon's wrist or forearm to maintain the insulation gases. As such, there is a need for a special seal formed around the wrist or forearm of a surgeon to prevent the escape of insulation gases. Moreover, it is desirable that the wound be retracted, protected and fixed while maintaining the insufflation seal.
SUMMARY OF THE INVENTION
• The invention is directed to a hand access system that provides hand access to a surgical area while maintaining pneumoperitoneum during laparoscopic surgery. The hand access system comprises a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor includes a first ring being adapted for disposition interiorly of the wound, a second ring being adapted for disposition exteriorly of the wound, and a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound. The hand access system further comprises a detachable hand seal adapted to be attached and detached from the second ring of the sheath retractor. In particular, the hand seal can be detached from the sheath retractor to convert the hand access system from laparoscopic surgery to open surgery. In one aspect, the first ring, second ring and sheath are formed from an elastomeric material, and the hand seal is formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of the instrument or hand. The gel material includes, for example, a thermoplastic base such as Kraton® and an oil. The resulting elastomer has excellent tear strength, elongation greater than 1,000 percent, a very low durometer or hardness, and biocompatibility. It is appreciated that the first ring has a first diameter and the second ring has a second diameter, and the first and second diameters are greater than the desired diameter of the wound.
• In another aspect, the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound. The sheath retractor may further comprise means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position. The retaining means may comprise a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position. The retaining means may include a wedge disposed between the third ring and the fourth ring.
• In yet another aspect of the invention, the hand access system may further comprise an adapter having a first adapter cavity for releasably attaching to a ring of the retractor sheath and a second adapter cavity for releasably attaching to the hand seal. The first adapter cavity has a first diameter and the second adapter cavity has a second diameter.
• In other aspects of the invention, the hand seal may include a cavity to receive the second ring of the sheath retractor, the hand seal may further comprise a latch on an inner diameter for latching the third ring, and the third ring may comprise at least a hook to latch the hand seal as the hand seal is attached to the sheath retractor. To facilitate sealing of the peritoneum, a conformable gasket may be provided that may be attached to the first ring or to the sheath of the sheath retractor, or the conformable gasket may float unattached to the sheath and interiorly of the wound.
• In another aspect of the invention, the hand access system may comprise a detachable iris seal in place of the hand seal that is adapted to be attached and detached from the sheath retractor. The iris seal comprises a first iris ring, a second iris ring coaxially attached to the first iris ring, and a cylindrical elastic member connected to the first and second iris rings and having an opening. With this aspect, the first and second iris rings operate to rotate relative to one another in either direction to open or close the opening of the cylindrical elastic member. More specifically, the first and second iris rings may be rotated in opposite directions to create an airtight constriction in the middle of the elastic member. After rotation, at least one of the first and second iris rings may be de-rotated to loosen or enlarge the constriction of the elastic member.
• Each of the iris rings may comprise a plurality of tracks to allow the iris rings to be relatively rotated at predetermined angles. In yet another aspect, the iris seal may further comprise a spring connecting the first and second iris rings to further facilitate a complete opening, a partial constriction or an airtight constriction of the opening of the elastic member. The spring operates to automatically pull and rotate the iris rings after de-rotation. In particular, as an object is withdrawn from the iris seal, the spring contracts and causes the sheath constriction to tighten automatically. The spring may be formed from an elastomeric material. It is appreciated that the amount the spring stretches and contracts is determined by the length of the spring. Each of the iris springs may comprise a hollow frame and a plurality of interlocking tracks. The interlocking tracks operate to encase the spring to prevent the spring from crossing into an instrument or hand passage area within the iris rings. The interlocking tracks also operate to open and close the seal at predetermined angles.
• In another aspect of the invention, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a valve including a plurality of overlapping sheets defining an access channel, and a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter, the access channel extends into communication with the incision in the patient. With this aspect, each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring. It is appreciated that the non-fixed portions provide open edges defining the access channel. In one aspect, the open edges slightly overlap for about 0.25″ at the center of the ring. The hand access device may further comprise a septum seal formed at the proximal end and at the distal end of the ring, the septum seal having a hole formed at the center of the seal. It is further appreciated that the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex and a cross-configuration.
• In yet another aspect of the invention, there is disclosed a surgical access device adapted for disposition relative to an incision in a patient comprising a plurality of septum layers each having a hole at the center of the septum layer and a first diameter, a ball sandwiched between the septum layers and having a second diameter greater than the first diameter, and a ring having an inner diameter for affixing the plurality of septum layers along the perimeter. In another aspect, a surgical access device facilitating a sealing relationship with an instrument or an arm of a surgeon extending through the device and into an incision in a patient is disclosed, the access device comprising a valve structure including a plurality of overlapping sheets defining an access channel, the valve in a first state forming a zero seal in the absence of the instrument or the arm of the surgeon extending through the valve structure, the valve in a second state forming an instrument seal in the presence of the instrument or the arm of the surgeon extending through the valve structure, and the access channel extends into communication with the incision in the patient.
• These and other features of the invention will become more apparent with a discussion of the various embodiments in reference to the associated drawings.
DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are included in and constitute a part of this specification, illustrate the embodiments of the invention and, together with the description, explain the features and principles of the invention. In the drawings:
• FIG. 1 is a perspective view showing a patient prone on an operating table with his abdomen insufflated and with instrument access provided by trocar and the access device of the present invention;
• FIGS. 2A and 2B illustrate a perspective view and a cross-sectional view, respectively, of a hand access system in accordance with a first embodiment of the invention;
• FIGS. 3A-3E illustrate axial perspective views and cross-sectional views of a hand access system in accordance with another embodiment of the invention including a one-way mechanism;
• FIGS. 4A and 4B illustrate cross-sectional views of a hand access system in accordance with another embodiment of the invention including an adapter;
• FIGS. 5A-5C illustrate an axial perspective view and cross-sectional views of a hand access system in accordance with another embodiment of the invention including a conformable gasket;
• FIG. 6 illustrates a cross-sectional view of a hand access system in accordance with another embodiment of the invention including an iris seal;
• FIGS. 7A-7E illustrate the rotation of the iris seal rings of the invention to create an airtight constriction in the middle of the sheath;
• FIGS. 8A-8C illustrate side views of another embodiment of the iris seal including a spring connecting the two rings;
• FIG. 9 illustrates a top view ofFIG. 8B;
• FIGS. 10 and 11 illustrate perspective and top views of rings of an iris seal having interlocking tracks in accordance with another embodiment of the invention;
• FIG. 12 illustrates a perspective view of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material in accordance with another embodiment of the invention;
• FIG. 13 illustrates a perspective view of a hand-assisted laparoscopic seal formed by differently shaped overlapping sheets of elastomeric material in accordance with another embodiment of the invention;
• FIGS. 14 and 15 illustrate perspective views of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material having concave and convex configurations;
• FIG. 16 illustrates a perspective view of a hand-assisted laparoscopic seal formed by overlapping sheets of elastomeric material including a central patch supported by spokes in accordance with another embodiment of the invention; and
• FIG. 17 illustrates a perspective view of a hand-assisted laparoscopic seal formed by two septum layers sandwiching a ball in accordance with another embodiment of the invention.
DESCRIPTION OF THE INVENTION
• Referring toFIG. 1, there is shown a typical abdominal surgery on a patient10 in a prone position on an operating table12.FIG. 1 further illustrates a surgeon having an arm16 and ahand17 performing the surgery. In the illustrated example, the operative procedure is performed within anabdominal cavity18 with instrument access provided through anabdominal wall21. In this type of operation, commonly referred to as laparoscopic surgery,trocars23 and25 are commonly used to provide minimally invasive access through theabdominal wall21 for instruments such as agrasper27 and anendoscope30. In addition, it is desirable that the surgeon be able to insert his/herhand17 through theabdominal wall21 and into theabdominal cavity18. The insertion of thehand17 provides the surgeon with direct access to various elements of the anatomy.
• In order to accommodate thehand17 and arm16 of the surgeon, asmall incision32 is typically created in theabdominal wall21. Anaccess device34 of the present invention can be provided to further facilitate this access by thehand17 of the surgeon. Particularly in the case of laparoscopic surgery, it is advantageous to insufflate theabdominal cavity18 with a gas, such as carbon dioxide, in order to elevate theabdominal wall21 and thereby increase the volume of the working space within thecavity18. Maintenance of this insufflation pressure, commonly referred to as pneumoperitoneum, is particularly difficult where access is desired across theabdominal wall21, for example, through thetrocars23,25, as well as theaccess device34. For this reason, a substantial effort has been directed to providing such access devices with sealing characteristics both in the presence of instruments and in the absence of instruments, such as thegrasper27,scope30 andhand17.
• Were it not for the desire to maintain the pneumoperitoneum, there would be no need for thetrocars23,25 or theaccess device34. That is, one would merely cut an incision in theabdominal wall21 and insert the instrument directly through the incision. However, without appropriate valves or seals, the insufflation gases would merely escape through theincision32. This would be particularly detrimental in the case of theincision32 which must be sufficiently large to accept thehand17 of the surgeon. Thus, theaccess device34 operates to form with theincision32 to provide an access or working channel, and to provide a valve or other sealing structure across the working channel in order to maintain the pneumoperitoneum.
• Referring toFIGS. 2A and 2B, there are shown a perspective view and a cross-sectional view, respectively, of ahand access system100 of the invention. Thehand access system100 provides hand access to a surgical area such as theabdominal cavity18 while maintaining pneumoperitoneum during laparoscopic surgery. Thehand access system100 comprises asheath retractor110 including aperitoneal ring112, aproximal ring114, and a sheath116 extending along anaxis117 connecting theperitoneal ring112 and theproximal ring114. The sheath116 has a generally cylindrical configuration that may be retracted to protect an incision within a body cavity such as theabdominal wall21. Theperitoneal ring112 andproximal ring114 are disposed in respective planes which extend radially of theaxis117. Thehand access system100 further comprises adetachable hand seal120 that is operably attachable and detachable to theproximal ring114 of thesheath retractor110 as illustrated inFIG. 2B to permit insufflation. It is appreciated that thehand seal120 can be separated from thesheath retractor110 to allow removal of large organs or to provide open access to theabdominal cavity18. Stated another way, thehand seal120 can be removed at any time to allow conversion from laparoscopic surgery to open surgery.
• It is further appreciated that wound retraction in accordance with the present invention allows a surgeon to easily locate thesheath retractor110 and to provide a base for thehand seal120. Thesheath retractor110 operates to remove the tissue pressure from the wrist during hand-assisted laparoscopic surgery. Thesheath retractor110 further protects tissue at the wound site, for example, from abrasion, bacteria or other contaminated organs, such as donor kidneys to be removed with minimal risk or damage. Thesheath retractor110 also opens the wound providing greater access to the operative site for instruments, such as the hand of the surgeon. In particular, thesheath protector110 includes the sheath116 having elastomeric properties that separate the tworings112,114. During surgery, theperitoneal ring112 is placed interiorly of theabdominal wall21 and theproximal ring114 is placed exteriorly of theabdominal wall21 and is then stretched beyond its natural state. The diameters of therings112,114 are greater than that of the wound site so as to provide sufficient footing and tension between therings112,114. This tension is created by the elastic material that has been stretched and retained at a distance greater than its natural state. It will be appreciated that in other embodiments, the sheath116 can be formed of a non-elastic sheathing material. In a similar manner, therings112,114 may be provided with a rigid configuration or alternatively may be formed of an elastomeric material.
• Referring toFIGS. 3A and 3B, there are shown perspective views of a hand access system100bwhere elements of structure similar to those previously described are designated by the same reference numeral followed by the lower case letter “b” in accordance with another embodiment of the invention. The sheath retractor110bcomprises a peritoneal ring112b,a proximal ring114b,a sheath116bextending along an axis117bconnecting the peritoneal ring112band the proximal ring114b,and a one-way mechanism118b(a cylindrical plug) that is placed to extend above the incision. More specifically, the one-way mechanism118bis placed between the peritoneal ring112band the proximal ring114b.The hand access system100bfurther comprises a “plug” hand seal120bthat is operably attached to the proximal ring114bof the sheath retractor110b.The hand seal120bcan be made of a soft gel material including a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of an instrument or hand. The gel material includes, for example, a thermoplastic base such as Kraton® and an oil. The resulting elastomer has excellent tear strength, elongation greater than 1,000 percent, a very low durometer or hardness, and biocompatibility.
• Referring toFIGS. 3C-3E, there are shown axial perspective views of an exemplary embodiment of the one-way mechanism118bof the invention. Specifically, the one-way mechanism118bcomprises two complimentary interlocking rings83 and90. The proximal ring114bcan be disposed outwardly of the sheath116band the lockingring90 can be disposed inwardly of the sheath116b.These tworings114band90 function to clamp the sheath116bso that thering83 is maintained in a fixed position by the lockingring90. The interlocking rings83,90 ofFIG. 3C provide for simple operation of the sheath retractor110b.These interlocking rings83,90 can be pushed down so that they rest on the outer surface of theabdominal wall21. As the sheath116bis drawn upwardly to achieve the proper degree of tension, it is easily moved between the interlocking rings83,90. However, any tendency of this sheath116bto move back into the wound site will tighten the interlocking relationship of therings83,90. Thus, the desired degree of tension is maintained on the sheath116buntil it is again pulled to release the lockingring90 from thering83.
• The one-way characteristics of the interlocking rings83,90 are further illustrated in the progressive views ofFIGS. 3D and 3E. With reference to these figures, it can be seen that retraction is maintained by preventing the sheath116bfrom pulling back into the wound by means of the one-way operation of the interlocking rings83,90. The sheath116bslides easily through the interlocking rings83,90 in the upper direction, but is prevented from sliding through therings83,90 in the downward direction. In order to disengage or separate the interlocking rings83,90, one needs only re-tension the sheath116bby pulling it proximally thereby unlocking therings83 and90. This enables thering83 to be removed from the sheath116bin order to remove the retractor116bfrom the wound site.
• In another aspect of the invention,FIGS. 4A and 4B illustrate axial perspective views of a hand access system100ccomprising a sheath retractor110c,anadapter140 and a detachable hand seal120c.The sheath retractor110cincludes a peritoneal ring112c,a proximal ring114c,and a sheath116cextending along an axis117cconnecting the peritoneal ring112cand the proximal ring114c.Theadapter140 comprises a first orlower ring142 for attaching to the proximal ring114cof the sheath retractor110c,and a second orupper ring144 for attaching to the detachable hand seal120c.FIG. 4B illustrates the hand access system100cwith the sheath retractor110c,theadapter140 and the hand seal120cinstalled. More specifically, theadapter140 is first attached to the proximal ring114cof the sheath retractor110c.In turn, the hand seal120cmay be attached and detached from theupper ring144 of theadapter140 as needed.
• It is appreciated that the proximal ring114cmay further include a movable ring, which together with the proximal ring114c,may be used to press down on theadapter140 against the abdomen, for example, to secure it and form an airtight connection. It is further appreciated that theupper ring144 may have a diameter that is greater than, equal to or less than the diameter of thelower ring142. In another aspect of the invention, theadapter140 may further comprise grooves to snap in a self-closing iris seal to gain pneumoperitoneum.
• FIGS. 5A-5C illustrate perspective and cross-sectional views of ahand access system100din accordance with yet another embodiment of the invention where elements of structure similar to those previously described are designated by the same reference numeral followed by the lower case letter “d”. Thehand access system100dcomprises asheath retractor110dand ahand seal120doperably attached to thesheath retractor110d.Thesheath retractor110dincludes aperitoneal ring112d,aproximal ring114d,a sheath (not shown) connecting theperitoneal ring112dand theproximal ring114d,and a one-way mechanism118dcomprising a plurality of interlocking rings83d,90d.Thehand seal120doperably attaches to theproximal ring114dof thesheath retractor110d.Thehand seal120dmay be formed of a soft gel material and includes a small slit to allow passage of a hand or a surgical instrument during surgery. Referring toFIG. 5B, there is shown a cross-sectional view of thehand seal120dhaving acavity125dinside the gel to receive theproximal ring114dof thesheath retractor110d.Referring toFIG. 5C, thehand seal120dmay further comprise alatch121don an inner diameter for latching the one-way mechanism118d.The access sheath material may be placed inside or outside of thehand seal120dafter attachment of thehand seal120dand theseal retractor110d.
• In another aspect, the one-way mechanism118dmay include hooks to latch thehand seal120das theseal120dis pressed down on the open end of the sheath. As explained above, thehand seal120dincludes a small slit in the gel that will not allow air to pass with the absence of an instrument or hand, but the slit will stretch and the gel will compress to allow objects to pass through with little loss of pneumoperitoneum. Compression of the gel onto theproximal ring114dof thesheath retractor110dcreates an airtight connection. Thesheath retractor110d,as illustrated inFIG. 5A, may further include a conformable gasket123dto facilitate sealing of the peritoneum. The conformable gasket123don the peritoneum ensures an airtight seal inside the incision as opposed to outside the incision. The gasket123dcan be attached to theperitoneal ring112dor the sheath116d,or it can float unattached to the sheath. The floating gasket123dis less likely to crease or bunch (a path for air leaks) as theabdominal wall21, sheath116dandperitoneal ring112ddistort as the sheath116dis pulled up into the incision. Without the need for sealing externally on the skin surface, the conformable gasket123dis not susceptible to air leaks from irregularities on the skin, such as scars or folds. Furthermore, the conformable gasket123dprotects theabdominal wall21 from potential traumatic pressure or abrasion by theperitoneal ring112d.
• In all of the above embodiments of the invention, the ability to attach and detach the hand seal from the sheath retractor allows larger objects to pass unfettered through the incision. In addition, the invention is easy to use, it provides increased comfort for the surgeon, and is less traumatic to tissue being passed through the incision. For example, the latching or interlocking feature of the hand seal and the adapter with the sheath retractor makes it fast and simple to use compared to other methods that may involve inflatable cuffs or adhesives. Adhesives often require time to cure and inflation with pumps also creates delay.
• In another aspect of the invention, the hand access system may comprise a sheath retractor and an iris seal directly connected to the sheath retractor to form a continuous, seamless sheath. Referring toFIG. 6, there is shown a hand access system in accordance with another embodiment of the invention including aniris seal200. Theiris seal200 comprises afirst ring202, asecond ring204 coaxially attachable to thefirst ring202, and a cylindricalelastic member206 connected to the first andsecond rings202,204 and having an opening. The first andsecond rings202,204 operate to rotate relative to one another in either direction to open or close the opening of the cylindricalelastic member206. In particular, theseal200 operates like the iris aperture of a camera, except that theiris seal200 is made of a thin film sheath orelastic member206. Aring202,204 is attached to each end of the sheath orelastic sheath206. Referring toFIGS. 7A-7C, therings202,204 are rotated in opposite directions to create an airtight constriction in the middle of the sheath orelastic member206. The constriction is maintained as long as the rotation is not undone (termed de-rotation). The sheath orelastic member206 can be made of an elastic material, which allows objects small in diameter relative to therings202,204 to pass easily through the constriction without the need for de-rotation. However, objects with large diameters may require de-rotation to loosen or enlarge the constriction in the sheath as illustrated inFIG. 7D. Once an object is withdrawn, therings202,204 must rotate back to create the airtight constriction as illustrated inFIG. 7E. In another aspect, therings202,204 may include a plurality oftracks207 such that they may be relatively rotated to open or close the opening at predetermined angles as further discussed below and illustrated inFIG. 10. More specifically, the sectional area of the opening changes in response to the predetermined angle rotation of the rings.
• Referring back toFIG. 6, theiris seal200 may be attached to asheath retractor110fhaving a peritoneal ring112f,a proximal ring114f,a sheath116fconnecting the peritoneal ring112fand the proximal ring114f,and a one-way mechanism118f(comprising a plurality of interlocking rings83f,90f). A feature of theiris seal200 is its constriction can be dilated as wide as the retracted incision and, as such, it may not be necessary for it to be detached from thesheath retractor110f.In this case, theiris seal200 can be made a permanent part of one of the interlocking rings of the one-way mechanism118f.Thus, the self-closingiris seal200 andsheath retractor110fcombination allows pneumoperitoneum to be regained more quickly without having to detach and reattach a seal as with previous methods. In another aspect, an iris seal can be easily removed when constructed as part of a two-ring design in the form of a wedge clamp similar to that shown inFIGS. 3C-3E. Pulling up on a sheath pushes or un-wedges the seal out of the sheath retractor.
• It is appreciated that other hand seals can be used and interchanged as contemplated by the concept of the invention. For example, the iris seal of the invention may further include aspring208 connecting the first andsecond rings202,204 to further facilitate the opening and closing of the opening of the cylindricalelastic member206. More particularly, one ormore springs208 may be used to connect the first andsecond rings202,204 to provide a complete opening, a partial constriction or an airtight constriction of the iris seal. Referring toFIGS. 8A-8C, there are shown perspective views of the iris seal200cof the invention further comprising thespring208 connecting the first andsecond rings202c,204c.FIG. 9 is a top view of the iris seal200cofFIG. 8B.
• As illustrated inFIGS. 8 and 9, as therings202c,204care rotated relative to one another, thespring208 expands and contracts causing opening and constriction of the seal. More specifically, thespring208 can be used to pull and rotate therings202c,204cautomatically after de-rotation, for example. The ends of thespring208 are connected to therings202c,204cin a manner such that de-rotation causes thespring208 to stretch as illustrated inFIGS. 8A and 8B. Afterwards, thespring208 contracts and causes the sheath constriction to tighten automatically as large objects are withdrawn (FIG. 8C). The amount thespring208 stretches and contracts is determined by the length of thespring208—typically larger objects require longer springs. Longer springs, however, may crossover the area within therings202c,204cand interfere with the passage of objects as illustrated inFIG. 9. To limit interference and to accommodate large objects, longer springs can be housed partially within a series of interlockingtracks207 of hollow frame rings202d,204das illustrated inFIGS. 10 and 11. In particular, the interlockingtracks207 on the rings can encase longer springs so they do not cross into the passage area. The interlocking tracks207 also operate to open and close the seal at predetermined angles.FIG. 11A illustrates an axial cross-sectional view of the seal with the springs contracted and the iris closed, andFIG. 11B illustrates an axial cross-sectional view of the seal with the springs expanded and the iris opened.
• An advantage of rotational adjustment, versus fixed rings, is that a wider range of object sizes can easily pass through the iris seal. A self-closing mechanism of the invention has the advantage of hands-free adjustment. In comparison to other self-closing methods that involve gears and springs that are connected to stationary components external to the iris seal, the spring(s) of the present invention are connected to and contained within the rings, which are integral to the iris seal. With the self-closing mechanism built in, the iris seal is portable and can be more easily adapted to a wide range of access ports, wound retractors and the like.
• In another aspect of the invention, a hand-assistedlaparoscopy seal300 is formed by overlappingseveral sheets302,304,306,308,310,312 of elastomeric material as illustrated, for example, inFIG. 12. Each of thesesheets302,304,306,308,310,312 is fixed along a portion of its perimeter to the circumference of a semi-rigid or rigid ring (not shown). As a result, each of the sheets302-312 has at least aportion302a,304a,306a,308a,310a,312aof its perimeter fixed to the ring and aportion302b,304b,306b,308b,310b,312bnot fixed to the ring. These non-fixed portions302b-312bprovide open edges within the area of the ring. The sheets302-312 are laid on top of one another and are rotated so that open edges extend along different planes. These open edges slightly overlap, such as approximately one-quarter inch, at the center of the ring to prevent leakage of the insufflation gas. During operation, an instrument or hand of the surgeon is introduced through the center of the ring forcing the open edges to part, but also causing the open edges to form a sealing structure around the forearm or wrist.
• It is appreciated that in the above aspect, the overlappingsheets302,312 may comprise two septum sheets having their full perimeters fixed to the ring and a hole formed at the center of the septum sheets. Referring toFIG. 13, there is shown another aspect of the invention where the open edges404b,406b,408b,410bhave different shapes, which when laid on top of one another, tend to form overlapping sections of a circle. It is appreciated that the concept of the invention contemplates any number of overlapping sheets of any material and of any shape. In one simple embodiment, for example, the invention contemplates two semi-circular sheets having slightly straight overlapping edges.
• In another aspect,FIGS. 14 and 15 show how the open edges can be provided with concave or convex configurations. The sheets or layers having convexopen edges506,510,608,610 tend to flex more while the sheets or layers havingconcave edges504,508,604,606 tend to give more support. The septum sheets or layers502,602 provide the most support. Other shapes can be used for the layers as illustrated in the embodiment ofFIG. 16 where one of the layers includes acentral patch704 supported byspokes704a,704b,704c,704dwhich extend to the ring. Thecentral patch704 is large enough to cover the hole702ain theseptum layer702. In the embodiment ofFIG. 17, two septum layers802,806 sandwich a ball804 which is movable within the confines of the ring. The ball804 has a diameter greater than the holes802a,806ain the septum layers802,806, respectively.
• It will be understood that many other modifications can be made to the various disclosed embodiments without departing from the spirit and scope of the invention. For these reasons, the above description should not be construed as limiting the invention, but should be interpreted as merely exemplary of the disclosed embodiments.

Claims (57)

1. A hand access system, comprising:

a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising

a first ring being adapted for disposition interiorly of the wound;

a second ring being adapted for disposition exteriorly of the wound; and

a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and

a detachable hand seal adapted to be attached and detached from the second ring of the sheath retractor.

2. The hand access system ofclaim 1, wherein the hand seal can be detached from the sheath retractor to convert the hand access system from laparoscopic surgery to open surgery.

3. The hand access system ofclaim 1, wherein at least one of the first ring, the second ring and the sheath is formed from an elastomeric material.

4. The hand access system ofclaim 1, wherein the hand seal is formed of a gel material and includes a slit providing an instrument seal in the presence of an instrument or hand and a zero seal in the absence of an instrument or hand.

5. The hand access system ofclaim 1, wherein the first ring has a first diameter and the second ring has a second diameter, and the first and second diameters are greater than the desired diameter of the wound.

6. The hand access system ofclaim 1, wherein the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound.

7. The hand access system ofclaim 6, wherein the sheath retractor further comprises means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position.

8. The hand access system ofclaim 7, wherein the retaining means comprises a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position.

9. The hand access system ofclaim 8, wherein the retaining means further comprises a wedge disposed between the third ring and the fourth ring.

10. The hand access system ofclaim 1, further comprising an adapter having a first adapter cavity for releasably attaching to the ring of the retractor sheath and a second adapter cavity for releasably attaching to the hand seal.

11. The hand access system ofclaim 10, wherein the first adapter cavity has a first diameter and the second adapter cavity has a second diameter less than or equal to the first diameter.

12. The hand access system ofclaim 1, wherein the hand seal includes a cavity to receive the second ring of the sheath retractor after installation of the hand seal.

13. The hand access system ofclaim 6, wherein the hand seal further comprises a latch on an inner diameter for latching the third ring.

14. The hand access system ofclaim 13, wherein the access sheath may be placed inside or outside of the hand seal after attachment of the hand seal and the seal retractor.

15. The hand access system ofclaim 6, wherein the third ring comprises at least one hook to latch the hand seal as the hand seal is attached to the sheath retractor.

16. The hand access system ofclaim 1, further comprising a conformable gasket to facilitate sealing of the peritoneum.

17. The hand access system ofclaim 16, wherein the conformable gasket is attached to the first ring or to the sheath of the sheath retractor.

18. The hand access system ofclaim 16, wherein the conformable gasket floats unattached to the sheath and interiorly of the wound.

19. A hand access system, comprising:

a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising

a first ring being adapted for disposition interiorly of the wound;

a second ring being adapted for disposition exteriorly of the wound; and

a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and

an iris seal adapted to be attached and detached from the sheath retractor.

20. The hand access system inclaim 19, wherein the iris seal comprises:

a first iris ring;

a second iris ring coaxially attached to the first iris ring; and

a cylindrical elastic member connected to the first and second iris rings and having an opening,

wherein the first and second iris rings operate to rotate relative to one another in either direction to open or close the opening of the cylindrical elastic member.

21. The hand access system inclaim 20, wherein the first and second iris rings are rotated in opposite directions to create an airtight constriction in the middle of the elastic member.

22. The hand access system inclaim 21, wherein at least one of the first and second iris rings is de-rotated to loosen or enlarge the constriction of the elastic member.

23. The hand access system inclaim 21, wherein each of the iris rings comprises a plurality of tracks to allow the iris rings to be relatively rotated at predetermined angles.

24. The hand access system inclaim 20, wherein the sheath retractor further comprises a third ring disposed circumferentially of the sheath and moveable between a plurality of positions between the first ring and the second ring, each of the positions being associated with a different retraction force, the third ring being adapted for disposition exteriorly of the wound.

25. The hand access system inclaim 24, wherein the sheath retractor further comprises means for retaining the third ring at one of the plurality of positions in order to provide the desired radial retraction force associated with that position.

26. The hand access system inclaim 25, wherein the retaining means comprises a fourth ring adapted to interlock with the third ring to fix the sheath at the desired position.

27. The hand access system inclaim 26, wherein the retaining means further comprises a wedge disposed between the third ring and the fourth ring.

28. The hand access system inclaim 24, wherein the third ring comprises at least one hook to latch the hand seal as the hand seal is attached to the sheath retractor.

29. The hand access system inclaim 20, further comprising a spring connecting the first and second iris rings to further facilitate a complete opening, a partial constriction or an airtight constriction of the opening of the elastic member.

30. The hand access system inclaim 29, wherein the spring automatically pulls and rotates the iris rings after de-rotation.

31. The hand access system inclaim 29, wherein the spring is formed from an elastomeric material.

32. The hand access system inclaim 29, wherein as an object is withdrawn from the iris seal, the spring contracts and causes the sheath constriction to tighten automatically.

33. The hand access system inclaim 29, wherein the amount the spring stretches and contracts is determined by the length of the spring.

34. The hand access system inclaim 29, wherein each of the iris springs comprises a hollow frame and a plurality of interlocking tracks.

35. The hand access system inclaim 34, wherein the interlocking tracks operate to encase the spring to prevent the spring from crossing into an instrument or hand passage area within the iris rings.

36. The hand access system inclaim 35, wherein the interlocking tracks operate to open and close the seal at predetermined angles.

37. A surgical access device adapted for disposition relative to an incision in a patient, comprising:

a valve including a plurality of overlapping sheets defining an access channel; and

a ring having an inner diameter for holding the valve by fixing each of the overlapping sheets along a portion of the perimeter,

wherein the access channel extends into communication with the incision in the patient.

38. The hand access device inclaim 37, wherein each of the overlapping sheets includes a portion of the perimeter that is not fixed to the inner diameter of the ring.

39. The hand access device inclaim 38, wherein the non-fixed portions provide open edges defining the access channel.

40. The hand access device inclaim 39, wherein the open edges slightly overlap at the center of the ring.

41. The hand access device inclaim 40, wherein the overlap is about 0.25″.

42. The hand access device inclaim 37, further comprising a septum seal formed at the proximal end of the ring and having a hole at the center of the seal.

43. The hand access device inclaim 42, further comprising a second septum seal formed at the distal end of the ring and having a hole at the center of the second septum seal.

44. The hand access device inclaim 39, wherein the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex, and a cross-configuration.

45. A surgical access device adapted for disposition relative to an incision in a patient, comprising:

a plurality of septum layers each having a hole at the center of the septum layer and a first diameter;

a ball sandwiched between the septum layers and having a second diameter greater than the first diameter; and

a ring having an inner diameter for affixing the plurality of septum layers along the perimeter.

46. A surgical access device facilitating a sealing relationship with an instrument or an arm of a surgeon extending through the device and into an incision in a patient, the access device comprising:

a valve structure including a plurality of overlapping sheets defining an access channel,

the valve in a first state forming a zero seal in the absence of the instrument or the arm of the surgeon extending through the valve structure,

the valve in a second state forming an instrument seal in the presence of the instrument or the arm of the surgeon extending through the valve structure, and

the access channel extends into communication with the incision in the patient.

47. The hand access device inclaim 46, further comprising a rigid or semi-rigid ring having an inner diameter for holding the valve structure by fixing each of the overlapping sheets along a portion of the perimeter.

48. The hand access device inclaim 46, wherein the zero seal and the instrument seal have properties for inhibiting the escape of liquids and gases through the valve structure.

49. The hand access device inclaim 46, wherein each of the overlapping sheets includes a portion the perimeter that is not fixed to the inner diameter of the ring.

50. The hand access device inclaim 49, wherein the non-fixed portions provide open edges defining the access channel.

51. The hand access device inclaim 50, wherein the open edges slightly overlap at the center of the ring.

52. The hand access device inclaim 47, further comprising a septum seal formed at the proximal end of the ring and having a hole at the center of the seal.

53. The hand access device inclaim 52, further comprising a second septum seal formed at the distal end of the ring and having a hole at the center of the second septum seal.

54. The hand access device inclaim 50, wherein the open edges of the non-fixed portions may have different shapes including at least one of a straight edge, concave, convex, and a cross-configuration.

55. A surgical access system facilitating a sealing relationship with a robotic device or an arm of surgeon extending through the access system and into an incision in a patient, comprising:

a sheath retractor adapted to dilate a wound stretchable to a desired diameter, the sheath retractor comprising

a first ring being adapted for disposition interiorly of the wound;

a second ring being adapted for disposition exteriorly of the wound; and

a sheath being disposed in a generally cylindrical form between the first ring and the second ring and operable to exert a radial retraction force on the wound; and

a detachable instrument seal adapted to be attached and detached from the second ring of the sheath retractor.

56. The surgical access system ofclaim 55, wherein at least one of the first ring, the second ring and the sheath is formed from an elastomeric material.

57. The surgical access system ofclaim 55, wherein the instrument seal is formed of a gel material and includes a slit providing an instrument seal in the presence of the robotic device or hand and a zero seal in the absence of the robotic device or hand.

Images