CA2195280A1 - Trocar with improved universal seal - Google Patents
Trocar with improved universal sealInfo
- Publication number
- CA2195280A1 CA2195280A1 CA002195280A CA2195280A CA2195280A1 CA 2195280 A1 CA2195280 A1 CA 2195280A1 CA 002195280 A CA002195280 A CA 002195280A CA 2195280 A CA2195280 A CA 2195280A CA 2195280 A1 CA2195280 A1 CA 2195280A1
- Authority
- CA
- Canada
- Prior art keywords
- seal
- trocar
- shore
- layer
- durometer scale
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
- A61B2017/3464—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
Abstract
A trocar containing a universal seal for sealing against surgical instruments ofvarying diameter to maintain insufflation in the body cavity is disclosed. The universal seal has an elastomeric sealing component with a centrally located interior region containing an aperture, and a concentrically located sealing region. The sealing region is composed of an integral laminate having an overlaying layer co-molded with an underlying layer. The overlaying layer has a hardness between about 40 Shore A
Durometer Scale and about 80 Shore D Durometer Scale. The underlying layer has a hardness between about 5 Shore A Durometer Scale and about 40 Shore A Durometer Scale. The co-molded laminate balances the properties of tear resistance and elasticity which are necessary for a working universal seal, and does so without the need for resilient legs or protectors to facilitate the opening of the aperture of the seal or to prevent tearing when instruments are inserted.
Durometer Scale and about 80 Shore D Durometer Scale. The underlying layer has a hardness between about 5 Shore A Durometer Scale and about 40 Shore A Durometer Scale. The co-molded laminate balances the properties of tear resistance and elasticity which are necessary for a working universal seal, and does so without the need for resilient legs or protectors to facilitate the opening of the aperture of the seal or to prevent tearing when instruments are inserted.
Description
21 9~2~0 TROCAR WITH IMPROVED UNIVERSAL SEAL
I3~k~:r~u~d of the Invention S This invention relates to a surgical trocar for ~ullc~lillg the body wall of a patient to provide access to a surgical site during endosc~ic surgery. More cally, it relates to a trocar incol~dlillg a universal seal to minimiæ or prevent leakage of incllffl~tion fluid from the surgical site through the trocar when instruments are inserted through the trocar.
A critical feature of a trocar is the design of the seal which prevents the passage of incl~ffl~tion fluid through the trocar when instruments of varying si_es are inserted through it. During çndoc~ ic surgery, the abdomen is inq)ffl~tPd with carbon dioxide to provide space between internal organs and bodily tissue duringsurgical procedures. First, the trocar obLuralol, which is the pullc~ ing implement of the trocar ~cc~Pmbly~ is used to pun~rc the ahdQmin~l wall. The trocar o~ tor issl~b~u.-,~lr removed, the ~omPn is infl~ and the trocar c^ln~ remains in place to provide access for surgical instruments to the surgical site. The cannula has a h~ing and a cannula tube e~tP-n~ling from the h~Jcing. It is the hr,usinp which c4u1~;nc the seal. The housing also c~u'~ c a valve, typically a flapper valve. When an instrument is inserted through the c~nn~ the instrument is inserted through the seal and causes the flapper valve to swing out of the way. The seal conro,l,.s to the outer di~mPter of the instrument, and ~,e,efo.~ prevents the i"~.~rn~lion gas from exiting the body through the hn~ucing of the c~nmll~ When the instrument is removed, 25 the flapper valve ~ .~o~lir~lly swings shut to likewise prevent il~urn~liQn gas from escaping.
One type of seal for a trocar is a simple gasket fixed to the cannula houcing which has a ~ rnet~pr sized for the insertion and withdrawal of instruments of generally fixed ~;~meter. ~lth~lgh simple in construction, it has the disadvantage of not being able to seal against instruments which have a rli~mpter smaller that that for which the seal was siæd. Accordingly, a reducer cap with a gasket (li~mPtPr smaller END-2g7 2 ! ~5280 than that of the housing to ~r~."mo l~te smaller sized instruments has been developed.
The cap snaps onto the housin~. Therefore, the surgeon can choose between the larger, fixed gasket of the h~lcing or the smaller one on the reducer cap to ensure that an ~e~lst~ seal around the ir,sll~l"~ nl would be ...~in~i..ed when the instrument is 5 inserted through the c~nn~ This reducer cap is described in U.S. Patent No.
5,338,307.
While the reducer cap provides a greater degree of flexibility for inserting hlstr~"~el.~ with varying .li~.... t .~ through the c~nn~ , it still requires the surgeon to 10 m~nirul~tP the cap to provide the proper seal. Accordingly, efforts have been undertaken to develop an improved seal for a trocar.
A desc~ io" of the first Uuniversal seal for a trocar is set forth in U.S.
Patent No. 5,395,342. The seal described in the '342 patent has an el~C~ e~ic cone 15 with an ~e,lure at its apex. The cone is fitted over a plurality of resilient legs eYten-ling from a frame fixed to the cannula h~ucing. When an instrument is inserted through the seal, the inst~"~enl Co~ the legs and causes them to expand against the el-Lt~----c-;c cone. This e-p - o.~ facilitates the ~ lIL-O~ of the a~.~ so it will c~l,rullll to the outer ~ PtPr of the ins~",enl. ~ignifi~ntly, the '342 patent 20 provides the first d~sclil)tion which inh,c,,lly tecog"i~s the less than desirable overall ~rOI"~ of seals cc---l~sed of convention~l el~t~m~Pric materials, such as cilirone Accordingly, it describes the use of resilient legs to f~-~ilit~te the e~ .L:on of the seal, which is a key factor in the overall pelrol",al,ce of the seal.
The rccognilion of the nece~s;ly of the legs to f~ilit~t~ the P.~ on of a seal colll~oscd of a conventi~n~l cl~c~,2...~ r~^lllrcd using conventi-n~l t~hni~es cannot be overstated. Without the legs, these el~t~meric materials will not expand si~ific~ntly. The~efore, if the ape, tu,e of the el~ctomeric seal is s~lbst~nsi~lly smaller than the outer ~i~rnetp~r of the instrument desired to be inserted through the c~nnl~l~
30 the mqtPriLql surroun~fin~ the ape~,e may tear when the instrument is inserted. This, 2 ~ 5 2 8 3 of course, is undesirable and may cause si~ifi~-qnt leakage of ills~lrnalion gas through the c-qrmlllq In q~ lition to the inability of conventionql elqetnmers to provide the requisite 5 degree of r.l.a~ m~, these conventionql materials may not provide the required degree of tear le~ e to prevent tearing of the sF~al when an ir,st~u",_nt with a pointed tip col-~ the outer ~.il,h_,~ of the seal. This may occur when the S.ltg~ iS trying to insert the in~llulllenl through the seal a~,lule, and misguides the tip so that it col.l;-~
the outer peliyhe~ instead of the centrally located a~llur~. The lack of tear10 ~e C' --~re has led to the dcv~ of seal designs to protect the e~ ....enc seal during insh~.,.cnl inse,liol~. For e~"~l~, U.S. Patent No. 5,342,315 describes the use of "protectors ~llou~lding the elqetomeric seal which come into direct contact with the i~,~u"~nl during hlst~ulll~nl insertion. The pr~leclul~ prevent direct contact of the instrument tip with the elq~t~...e,ic seal, and ll~er~rol~; ~ignific-q-ntly minimi7~ or 15 prevent the h,sllun,~nl tip from tearing the outer pc.iphe.~ of the seal. Another p~teclor confi~lration dÇ'~ F'd to isolate the il~tlu~el~l from the outer ~.i~ of the el~ ....c ;c seal is described in U.S. Patent No. 5,308,336.
,~ltllough universal seals for trocars have been developed to provide a seal 20 against insllu"le~ of varying ~ ...c~,~, none of these seals is capable of ov~.~",ing the s~b~ r~;Fnc:es inherent in the use of convçntion~l e~ .. ic materials which are suitable for surgical app~ qtinnc Th r~rO~, these seals have required the use of ~itinnql seal c.~ such as resilient legs or prot_ctors to o~.wl"F these material ~r~c:c~(:es U"rul~tely, these n(lAitionql co~pQn~FI-l~ add cost, 25 .. I..fi- I..rillg complexity and ~luoed reliability to the overall seal design. It would be highly d ~ e, in view of this on~ing .~re:c ~ y~ to devel~p a universal seal for a trxar which does not require the use of resilient legs or protec~l~ to fX~lllpÇIl~t~ for tF~ ries of c onvçntion~l ei~t~mçric m~q~t~ri~lc adapted for surgical appli-~tionc~
`21 95280 S... ~. y of the Invention The invention is a trocar for providing access for insertion and withdrawal of surgical il,sl,u---cl-ls to and from a surgical site within a body cavity. The trocar S co ,~,ises a trocar cannula and a seal assembly.
The trocar cannula has a cannula h~using and a tubular sleeve eYtenAing from the h~lcing The cannula housing has a passageway co.. ~ni~ling with the sleeve.The passageway creates a path through the cannula for providing the access for 10 insertion and withdrawal of the surgical instruments.
The seal qcsembly is fixed to the cannula houcing in the path of the passageway co.. ~ ;.. g through the trocar cqnnul-q The seal assembly in~luAfes a seal c~ A of an el~r'~...c-ic material for sealing against the surgical instr.~ u~ls 15 having varying ~ ~ ..f ~ . ~. The seal has a centrally located interior region col~-;ni~g an ~pe.tu~. A sealing region is c~luY-~.I.ically located about the interior region of the seal. The sealing region co --~-i~s an integral lqminq~ which is co-molded from the el~C~ ic material. The Iqnin~ has a first underlying layer and a second o~_lld~ing layer. The first underlying layer has a Shore A Du.~mftu. hardnfs~
20 ~h. cn about 5 and about 40. The second overlaying layer has a hal~Rs~ bcl~cen about 40 Shore A Durometer and about 80 Shore D Durometer.
Signific-qntly, the second overlaying layer which is co-molded with the first underlying layer to make the integral lqminqt~ of the sealing region of the seal25 ,q-ccpmbly eliminqt~C the need to incul~latc resilient legs or l)r~ into the seal ~Cc~mbly. The second o~_.l~ing layer has a I~J-~e~ greater than that of the first underlying layer. The~folc, the contact area and the frictional force between anin~tlulllfnt as it is inserted through the cannula and the second overlaying layer is much less than it would be if it were in direct contact with the underlying layer. In 30 ~d-lhiQn~ the second overlaying layer has greater ~ c~ to tearing when it comes into contact with the inserted in~llu,l,cnl. CG"e~ndingly, the first underlying layer has greater elasticity than the second overlaying layer, and concP~ ently f~rilitq-t~s the stretching of the ape,tur~ in the interior region of the seal assembly when an instrument having a Ai- "~tPr greater than that of the aperture is inserted through the 5 c-qnn-~lq The seal ~q-lqncps the need for tear resictqnre on the surface c4l.lArl;"e the instrument with elasticity to facilitate the stretching of the ~Itur~ without ripping during insertion. As a result, the need for costly additional c~ n~ for the sealassembly to u~hA~re tear re~:C~--re or elasticily of the seal, such as resilient legs and pr~lect~"~, is avoided.
Furthermore, the sealing region of the seal assembly of the trocar of this invention enables smooth withdrawal of h,sl,u"l~nls from the trocar cannula without c-qt~hine or cna~gine onto the seal qc~ml)ly as the instruments are withdrawn. This is because the seal q-c~mbly does not need to inco,~,~le additional co",pol-e"t~
15 projecting into the sealing region. The,efo.e, damage to the seal qc~mbly is minimi7PA ~ddition~qllly~ the sealing region will readily evert when instruments are withdrawn because the second overlaying layer exhibits increased stiffness. This too d~,~s the chance for damage to the seal q-c~mbly. Finally, the ability to removetissue ~ . ,,c from the body through the trocar cannula is enh~-reA. because 20 IA~ nql seal c~ ~n~ are ~ ~y which would obi~tl.lcl the cannula ~)as~b~ y.
The el-qctomeric seal of the seal assembly can be configured in numerous shapes. For example, the seal can be flat or conical. Preferably, the second 25 ove,layi"g layer of the sealing region can be displayed as a plurality of separate or inle~c4nn~~ d c~r~l-l-ic plates on top of the first underlying layer. Most preferably, the second o~e-la~ring layer is a plurality of S~)~dt~ plates on top of the first underlying layer. In this emboAiment~ when an i"sl,u",ent is inserted through the seal assembly, the ,~.g~nented nature of the overlaying layer minimi7~s its dero""alion 30 while the underlying layer between the separate plates, ~e~ifi~qlly chosen for its ability to deform, accepts the defolllla~ioll. In effect, the underlying layer in this prerel,l d embodiment actually affords protection of the overlaying layer.
Alternatively, the æcond overlaying layer may be a contin~ )c layer o~
5 molded on top of the first underlying layer.
The trocar of this invention has a æal assembly which æals against surgical instruments of varying ~ rnet~prs to ~ ;-- in~vrll;~lion in the body cavity during endosc~ic surgery. As of the filing date of this appli~tion~ surgical instruments with 10 ~ eh~ between 5-12 mm have convçn~inn~lly been uæd during ~nd~ s~pic surgery. Con~en~ly~ the æal asæmbly of the trocar of this invention can ~".""o~l~t~ the inærtion and withdrawal of instruments with ~ nlet~rs in this range.
In the current invention, the seal assembly can ~.. odate instruments within a wider or l~-u.._l range of ~li5' The trocar of this invention can be used in all of the surgical procedures wheretrocars have conv~ntiQn~lly been used or con~.llplalcd for use. Of course, the trocar of this invention is particularly adapted for e~ldoscQyic applin~tionc where it is n~ ~.y to insert i~ lllcn~ of varying .li~ t~ f through the trocar while still 20 ".~inl~;.,i.,g i-.~-rn~;O~ within the body cavity.
Brief Descripdon of the Dla~. il.FS
Figure 1 is a ~l~ti~e view of the seal ~ccPrnbly of the trocar of this 25 invention shown ;n partial cross-section.
Figure 2 is a pel~li~re view of the trocar providing access for a surgical instrument within a body cavity, where the seal ~cc~rnbly illustrated in Figure 1 is att~rh~A to the trocar.
- 21 9~2~0 Figure 3 is an exploded ~,~;li-/e view of the seal assembly illustrated in Figure 1.
Figure 4 is a pe.~ e view of the el~ctomeric seal COlll~nGn~ of the seal 5 ~Ccembly illustrated in Figure 1.
Figure S is a fr~grnent~ ye~ e view in partial cross-section of the e~ ...elic seal cr.~ e~-l as seen along view line 5-5 of Figure 4.
Figure 6 is an enlarged fr~gm~ry view of the el~ct~meric seal co~.lpol-P-~-t shown in Figures 4 and 5.
Figure 7 is a scl-e...-~ic top plan view of the seal assembly sealing against a surgical i--~hu~ ,nl as seen along view line 7-7 of Figure 2.
Figure 8 is a view similar to Figure 7 in which the instlul..h~l is of a larger t~ . .
Figures 9-15 are pe~ e views of alternate embo~limentc for the seal 20 ~c~mbly of the trocar of this invention.
net~iled Description of the ~lGrel,-,d Embodiments A plGfellGd seal assembly 20 for the trocar of this invention is illustrated in 25 Figure 1. The seal ~csembly is an integrated unit which is decigt ed to snap onto the houcin~ of the trocar c~nn~ It has a frame 21 which is sized to fit over the top of the cannula h~-~;ng. The frame has an GAt~,lior planar face 22 and an interior region 23 which is po5i~ioned within the cannula hw~ing The interior region includes a resilient latches 24 which secures the seal assembly to the h~lcing It also inrlu~Los a 30 neck 25 to f~rilit~tP the ~ nGe of surgical instruments through the r~nmll~ as they are inserted into and withdrawn from the c~nnul~ and to seal the assembly 20 ag~unst the outer gasket of the trocar to prevent the escape of gas around the frame 21.
The seal ~c~mbly depicted in Figure 1 has an el~rt~meric seal 26 to seal S against instruments which are inserted into and withdrawn from the c~nnul~ The seal is po~;tion~ centrally within the seal assembly. The seal incl~ldes a centrally pnCitinned a~cltul~ 27 to permit the passage of the inslru",en~. Adv~ntageoucly, the aperture has a ~ . et~ between about 2.5 to about 5 mm so it c~n seal not only ag~unst the cm~ p-st endoscQp.c i"sl~w"en~ but also 12 mm instruments and larger10 ones as well.
Referring to Figure 2, the trocar 28 of this invention is seen to provide accessfor the insertion for a surgical instrument 29 into a body cavity. The body wall 30 of the surgical patient is l)unct~lred with the trocar ob~ lor (not shown), and the15 oblur~ is subse~lPntly withdrawn from the cannula 31. The cannula has a houcing 32 with an interior ch~mh~r 33 (see Figures 7 and 8), and an elon~tP~ cylindrical sleeve 34 ey~n~ing from the houcing. The sleeve extends through the olxning madein the hody wall. At the pr~Ai."al end of the cannula houcin~, the seal ~ccPmhlly 20 is secured. A pas~ge..ay 35 is provided through the ~llur~; of the seal ~cc~Pmbly, into 20 ~e ch~mbp~r of the cannula h~llcing, and finally through the lumen of the tubular sleeve to provide a path for the insertion and withdrawal of a surgical instrument into the body cavity.
The c~",~onents of the plcfe.lcd seal assembly 20 are illustrated in Figure 3.
25 The frame is a su~c~mbly which has a top frame half 36 and a bottom frame half 37.
Sandwiched between the top and bottom frame halves is the el~lo...l . ic seal 26. The seal is position~Pd between upper and lower rigid rings, 38 and 39 ,e~ecli.~ely. The upper ring has a plurality of prongs 40 which are fitted through the seal and are received in a plurality of receiving holes 41 in the lower ring. The top and bottom 30 frame halves define an internal cavity 42 for receiving the seal 26. The top frame half 21 952~0 g has a circular opçning 43 sized to fit an insll~",en~ with the largest ~la~fst~rcontemplated. -Co~ sl.o~ ngly, the bottom frame half h s a similarly sized opfning 44 which is filnnf le~ to form the neck 25 of the se. l qc~mbly. A det. iled d~ lion of a seal qcc~mbly with similar coll-poncn~ is described in U.S. Patent No. 5,342,315.
Referring now to Figures 4-6, the seal C~ f~ 26 of the prcr~ d se~
qc~embly is illustrated. The se~ is made of a medical grade el~Q~omer. ~wliples of suitable cl-r~....e.~ include, but are not limited to, silicone rubber, polyurethane elqrt~mer, chlorobutyl rubber, latex rubber, polyisoprene rubber and ethylene 10 p~c~yl~ diene monomer (EPDM") rubber. The plere.l~ el~ nc~ are silicone rubber and l)O!yu~ f rubber. The most plefcll~d el~ct~lmer is meA:--ql grade cili~ne, for e~lll)lc, Dow Corning Slastic~ brand medical grade silicone rubber.
The seal has inner and outer portions, 45 and 46, ~i,~e~ti-rely. The inner and 15 outer portions are divided by the upper and lower rigid rings. The outer portion of the seal has a bellows c~ nfi~ ion, As ~ se~ in U.S. Patent Nos. 5,073,169 and 5,209,736, the bellows facilitates the ...G;u~ ~nce of a seal during radial motion of surgical h~stlull,cnls which are inserted into and withdrawn from the c~nmll~ The inner portion of the seal has a centrally located interior region 47 which c~n~;..C the 20 d~-tUrc 27 for passage of the surgical instruments. The circumferential surface of the aperture seals against ir,~tlulllc.l~ because it provides the surface against which the i~l~ulllhlt~ come into contact. A sealing region 48 is c4--ceulr;c~11y located about the interior region of the seal. It is this sealing region which SUppOll~i the aperture 27 of the interior region of the seal ~c~embly when instruments are inserted and withdrawn, 25 and l,l.,._n~s or minimi7es the escape of il.~urll~lion gas from the body cavity through the trocar c~nn~ . Accordingly, the seal region must have the dual propellies ofela~lici~y to enable the passage of large instruments through the aperture 27, and toughnecc to prevent ripping when misaligned instruments are forced against the sealing region.
Signific~ntly, the sealing region has two layers. It has a first underlying layer 49 located interiorly towards the surgical patient, and a second overlaying layer 50 positioned on top of the first layer. The two layers are integral with each other to create an integral l~min~tP. The l~min~tP of the e~ mer can be made using 5 convPntion~l inie~tion co-molding techniques which are well known in the art. In other words, the first underlying layer of the el~ct~mçr is initially molded, and then the second ove,layil-g layer of the el~-h,~,-cr is subsP~çntly molded on top of the first layer to create the integral laminate. The underlying layer is elastic so that the ape,nl,c will stretch in ~ ~nse to instrument insertion, and the ove,la~ g layer is 10 tear r~;~ll to prevent ripping. Accordingly, the tear ee~;c~ re of the overlaying layer is adv~nt~gPouc1y greater than that of the underlying layer.
Generally, the specific tear strength chosen for the underlying and overlaying layers will depend on the degree of rÇcict~nce to seal tearing desired, which 15 co"~ ondingly ~iepen~c on the size of surgical instruments inserted into and withdrawn from the trocar cannula and the shape of the end effe~ of these instruments. In ~ litinn, the tear strength will also depend on the particular confi~..dlion of the e~ .n~-ic seal. For example, a seal which has a confi~-ration with a large surface area to f~ilit~te e~ o~ of the seal a~llu,l may need less tear 20 strength than a seal with a confi~-ration widl a small surface area. The,efole, the specific hardl.ess for the underlying and overlaying layers may be readily determined e.--~,i,icdlly. Nevertheless, the first underlying layer of the el~t~mer in the sealing region of the sealing ~c~mbly preferably has a hardness belw~-- about 5 Shore A
D~lr~...eter Scale and about 40 Shore A Durometer Scale. The second overlaying 25 layer has a hardl,ei,~ which is p,efeldbly between about 40 Shore A Durometer Scale and about 80 Shore D Durometer Scale. The har.h-ejs of the el~ct~m~r can be determined using the standard test method for harJI-ess of the thermoplastic el~ctQmers set forth in ASTMD 2240 91.
21 952~0 Overall, if the hardness of the first underlying layer is less than about 5 Shore A Durometer Scale, then the underlying layer may become very adherent or "sticky"
to the h,~ ellt inserted through the seal assembly, con~quçntly causing high friction and leading to the possible tearing of the seal assembly. Coll~ ~n~ingly~ if S the hal~less of the first underlying layer is greater than about 40 Shore A D~llu~ r Scale, then the underlying layer becomes h~cr~as;llgly stiff, minimi7ing the fleYibility or e1ong~ion of the layer which may cause the possible tearing of the layer or an incr~ in instrument insertion force. If the second overlaying layer has a hardness less than about 40 Shore A Durometer Scale, then there is the potential for incr~d 10 friction and surface contact belween the instrument and the seal which may cause tearing of the seal ~ccPmbly. Coll~ ondingly, if the second overlaying layer has a hardl,ess greater than about 80 Shore D Durometer Scale, then there is the poLenlial for the shearing of the first underlaying layer upon instrument withdrawal which may cause tearing of the seal ~c~mbly. Also, a harJI~ess greater than 80 Shore D
15 Durometer Scale minimi7~s the elastic flexibility of the overlaying layer, thus ~t~lllially inhibiting tissue removal and causing instrument snags. Preferably, the first und~llying layer of the sealing region of the sealing assembly has a hardness l;.,h.~n ahout 30 Shore A Dulullleter Scale and ahout 40 Shore A Dululll~r Scale.
The second overlaying layer of the sealing region pl~;fe...bly has a tear recict~n~
20 between about 50 Shore A Durometer Scale and about 80 Shore D Durometer Scale.
Most preferably, the second overlaying layer has a tear resist~nce between about 60 Shore A Durometer Scale and about 70 Shore A Durometer Scale.
The sealing region of the seal assembly depicted in Figures 4-6 is confi&llred as 25 a shallow cone. The overlaying layer of the co-molded integrate l~minate is displayed as a plurality of sep~dt~ rP~"~ic plates 51 in the form of l~uncaLed triangles.
Figures 7 and 8 depict the insertion of surgical instruments of varying ~ meter through the trocar cannula 31, and the seal which is created between the instrument 29 30 and the sealing region 48 of the seal ~c~mbly 30. As the insl,~menl is inserted 21 5528~
through the a~,ture of the seal, the aperture e-~r~n~C to ~r~l.. o~te the outside I~iA~llel~r of the i.ls~ n~ in erted through the seal.
Referring briefly now to Figures 9-15, there are illustrated alternative S en bo~limpntc for the confi~,..alion of the seal co.l.ponenl 26 of the seal assembly for the trocar of this invention. Figure 9 depicts a second overlaying layer of the sealing region 48 as a plurality of i.,t. ,.~ -fcled c4l-rf~ .ic plates 52. Figure 10 illustrates the second ov. .l~;"g layer region of the sealing region a a c~ntinuouC layer 53 co-molded over ~b~nti~lly the entire surface of the underlying layer. In Figures 11-13, 10 the sealing region of the seal ~csembly is c~nfi~lred as a flat seal instead of a shallow cone. Alternatively, the sealing region can be c~nfi~lred as a deep cone a shown in Figures 14 and 15. In the embor~ pntc of Figures 14 and 15, the outer portion 46 of the seal del)ic~l in Figures 4 and 9-13 have been çlimin~tPA
In another embodiment of this invention, the seal assembly may be insert molded directly to the interior wall of the cannula h~ usin~ of the trocar instead of the latch "1. rl~ U~ ctm~-i in Figures 1 and 2. For e~..~,'e, the cannula h(u-cing c~n be initially inserted into a mold. The first underlying layer of the sealing region of the seal ~csembly can be injected into the mold to form the outer pe,i...et~r of the seal as 20 well as to form a . .c~l,Al-ir~l interlock with the cannula hollcinE. Sub~ently, the second o~ lla~ ;ng layer may be co-injected into the mold. Once the e~ is fully cured, the cannula h~llsing can be ~emol~le~
~lthMl~h this invention has been described in co~,-e~liQn with its most 25 I)refe"cd e-mbo l;...c~ , n.~ el.)us ~l~iti- n~l embo~imrntc can readily be contemrlated by those skilled in the art and lllc,tfo-c fall within the sc~pe and spirit of the cl~imed invention. The detailed desc~iy~ion of the pr~fc,-ed çmbo limrntc are exemplary only, and should not be construed in any way to limit the scope of thecl~imçd invention.
I3~k~:r~u~d of the Invention S This invention relates to a surgical trocar for ~ullc~lillg the body wall of a patient to provide access to a surgical site during endosc~ic surgery. More cally, it relates to a trocar incol~dlillg a universal seal to minimiæ or prevent leakage of incllffl~tion fluid from the surgical site through the trocar when instruments are inserted through the trocar.
A critical feature of a trocar is the design of the seal which prevents the passage of incl~ffl~tion fluid through the trocar when instruments of varying si_es are inserted through it. During çndoc~ ic surgery, the abdomen is inq)ffl~tPd with carbon dioxide to provide space between internal organs and bodily tissue duringsurgical procedures. First, the trocar obLuralol, which is the pullc~ ing implement of the trocar ~cc~Pmbly~ is used to pun~rc the ahdQmin~l wall. The trocar o~ tor issl~b~u.-,~lr removed, the ~omPn is infl~ and the trocar c^ln~ remains in place to provide access for surgical instruments to the surgical site. The cannula has a h~ing and a cannula tube e~tP-n~ling from the h~Jcing. It is the hr,usinp which c4u1~;nc the seal. The housing also c~u'~ c a valve, typically a flapper valve. When an instrument is inserted through the c~nn~ the instrument is inserted through the seal and causes the flapper valve to swing out of the way. The seal conro,l,.s to the outer di~mPter of the instrument, and ~,e,efo.~ prevents the i"~.~rn~lion gas from exiting the body through the hn~ucing of the c~nmll~ When the instrument is removed, 25 the flapper valve ~ .~o~lir~lly swings shut to likewise prevent il~urn~liQn gas from escaping.
One type of seal for a trocar is a simple gasket fixed to the cannula houcing which has a ~ rnet~pr sized for the insertion and withdrawal of instruments of generally fixed ~;~meter. ~lth~lgh simple in construction, it has the disadvantage of not being able to seal against instruments which have a rli~mpter smaller that that for which the seal was siæd. Accordingly, a reducer cap with a gasket (li~mPtPr smaller END-2g7 2 ! ~5280 than that of the housing to ~r~."mo l~te smaller sized instruments has been developed.
The cap snaps onto the housin~. Therefore, the surgeon can choose between the larger, fixed gasket of the h~lcing or the smaller one on the reducer cap to ensure that an ~e~lst~ seal around the ir,sll~l"~ nl would be ...~in~i..ed when the instrument is 5 inserted through the c~nn~ This reducer cap is described in U.S. Patent No.
5,338,307.
While the reducer cap provides a greater degree of flexibility for inserting hlstr~"~el.~ with varying .li~.... t .~ through the c~nn~ , it still requires the surgeon to 10 m~nirul~tP the cap to provide the proper seal. Accordingly, efforts have been undertaken to develop an improved seal for a trocar.
A desc~ io" of the first Uuniversal seal for a trocar is set forth in U.S.
Patent No. 5,395,342. The seal described in the '342 patent has an el~C~ e~ic cone 15 with an ~e,lure at its apex. The cone is fitted over a plurality of resilient legs eYten-ling from a frame fixed to the cannula h~ucing. When an instrument is inserted through the seal, the inst~"~enl Co~ the legs and causes them to expand against the el-Lt~----c-;c cone. This e-p - o.~ facilitates the ~ lIL-O~ of the a~.~ so it will c~l,rullll to the outer ~ PtPr of the ins~",enl. ~ignifi~ntly, the '342 patent 20 provides the first d~sclil)tion which inh,c,,lly tecog"i~s the less than desirable overall ~rOI"~ of seals cc---l~sed of convention~l el~t~m~Pric materials, such as cilirone Accordingly, it describes the use of resilient legs to f~-~ilit~te the e~ .L:on of the seal, which is a key factor in the overall pelrol",al,ce of the seal.
The rccognilion of the nece~s;ly of the legs to f~ilit~t~ the P.~ on of a seal colll~oscd of a conventi~n~l cl~c~,2...~ r~^lllrcd using conventi-n~l t~hni~es cannot be overstated. Without the legs, these el~t~meric materials will not expand si~ific~ntly. The~efore, if the ape, tu,e of the el~ctomeric seal is s~lbst~nsi~lly smaller than the outer ~i~rnetp~r of the instrument desired to be inserted through the c~nnl~l~
30 the mqtPriLql surroun~fin~ the ape~,e may tear when the instrument is inserted. This, 2 ~ 5 2 8 3 of course, is undesirable and may cause si~ifi~-qnt leakage of ills~lrnalion gas through the c-qrmlllq In q~ lition to the inability of conventionql elqetnmers to provide the requisite 5 degree of r.l.a~ m~, these conventionql materials may not provide the required degree of tear le~ e to prevent tearing of the sF~al when an ir,st~u",_nt with a pointed tip col-~ the outer ~.il,h_,~ of the seal. This may occur when the S.ltg~ iS trying to insert the in~llulllenl through the seal a~,lule, and misguides the tip so that it col.l;-~
the outer peliyhe~ instead of the centrally located a~llur~. The lack of tear10 ~e C' --~re has led to the dcv~ of seal designs to protect the e~ ....enc seal during insh~.,.cnl inse,liol~. For e~"~l~, U.S. Patent No. 5,342,315 describes the use of "protectors ~llou~lding the elqetomeric seal which come into direct contact with the i~,~u"~nl during hlst~ulll~nl insertion. The pr~leclul~ prevent direct contact of the instrument tip with the elq~t~...e,ic seal, and ll~er~rol~; ~ignific-q-ntly minimi7~ or 15 prevent the h,sllun,~nl tip from tearing the outer pc.iphe.~ of the seal. Another p~teclor confi~lration dÇ'~ F'd to isolate the il~tlu~el~l from the outer ~.i~ of the el~ ....c ;c seal is described in U.S. Patent No. 5,308,336.
,~ltllough universal seals for trocars have been developed to provide a seal 20 against insllu"le~ of varying ~ ...c~,~, none of these seals is capable of ov~.~",ing the s~b~ r~;Fnc:es inherent in the use of convçntion~l e~ .. ic materials which are suitable for surgical app~ qtinnc Th r~rO~, these seals have required the use of ~itinnql seal c.~ such as resilient legs or prot_ctors to o~.wl"F these material ~r~c:c~(:es U"rul~tely, these n(lAitionql co~pQn~FI-l~ add cost, 25 .. I..fi- I..rillg complexity and ~luoed reliability to the overall seal design. It would be highly d ~ e, in view of this on~ing .~re:c ~ y~ to devel~p a universal seal for a trxar which does not require the use of resilient legs or protec~l~ to fX~lllpÇIl~t~ for tF~ ries of c onvçntion~l ei~t~mçric m~q~t~ri~lc adapted for surgical appli-~tionc~
`21 95280 S... ~. y of the Invention The invention is a trocar for providing access for insertion and withdrawal of surgical il,sl,u---cl-ls to and from a surgical site within a body cavity. The trocar S co ,~,ises a trocar cannula and a seal assembly.
The trocar cannula has a cannula h~using and a tubular sleeve eYtenAing from the h~lcing The cannula housing has a passageway co.. ~ni~ling with the sleeve.The passageway creates a path through the cannula for providing the access for 10 insertion and withdrawal of the surgical instruments.
The seal qcsembly is fixed to the cannula houcing in the path of the passageway co.. ~ ;.. g through the trocar cqnnul-q The seal assembly in~luAfes a seal c~ A of an el~r'~...c-ic material for sealing against the surgical instr.~ u~ls 15 having varying ~ ~ ..f ~ . ~. The seal has a centrally located interior region col~-;ni~g an ~pe.tu~. A sealing region is c~luY-~.I.ically located about the interior region of the seal. The sealing region co --~-i~s an integral lqminq~ which is co-molded from the el~C~ ic material. The Iqnin~ has a first underlying layer and a second o~_lld~ing layer. The first underlying layer has a Shore A Du.~mftu. hardnfs~
20 ~h. cn about 5 and about 40. The second overlaying layer has a hal~Rs~ bcl~cen about 40 Shore A Durometer and about 80 Shore D Durometer.
Signific-qntly, the second overlaying layer which is co-molded with the first underlying layer to make the integral lqminqt~ of the sealing region of the seal25 ,q-ccpmbly eliminqt~C the need to incul~latc resilient legs or l)r~ into the seal ~Cc~mbly. The second o~_.l~ing layer has a I~J-~e~ greater than that of the first underlying layer. The~folc, the contact area and the frictional force between anin~tlulllfnt as it is inserted through the cannula and the second overlaying layer is much less than it would be if it were in direct contact with the underlying layer. In 30 ~d-lhiQn~ the second overlaying layer has greater ~ c~ to tearing when it comes into contact with the inserted in~llu,l,cnl. CG"e~ndingly, the first underlying layer has greater elasticity than the second overlaying layer, and concP~ ently f~rilitq-t~s the stretching of the ape,tur~ in the interior region of the seal assembly when an instrument having a Ai- "~tPr greater than that of the aperture is inserted through the 5 c-qnn-~lq The seal ~q-lqncps the need for tear resictqnre on the surface c4l.lArl;"e the instrument with elasticity to facilitate the stretching of the ~Itur~ without ripping during insertion. As a result, the need for costly additional c~ n~ for the sealassembly to u~hA~re tear re~:C~--re or elasticily of the seal, such as resilient legs and pr~lect~"~, is avoided.
Furthermore, the sealing region of the seal assembly of the trocar of this invention enables smooth withdrawal of h,sl,u"l~nls from the trocar cannula without c-qt~hine or cna~gine onto the seal qc~ml)ly as the instruments are withdrawn. This is because the seal q-c~mbly does not need to inco,~,~le additional co",pol-e"t~
15 projecting into the sealing region. The,efo.e, damage to the seal qc~mbly is minimi7PA ~ddition~qllly~ the sealing region will readily evert when instruments are withdrawn because the second overlaying layer exhibits increased stiffness. This too d~,~s the chance for damage to the seal q-c~mbly. Finally, the ability to removetissue ~ . ,,c from the body through the trocar cannula is enh~-reA. because 20 IA~ nql seal c~ ~n~ are ~ ~y which would obi~tl.lcl the cannula ~)as~b~ y.
The el-qctomeric seal of the seal assembly can be configured in numerous shapes. For example, the seal can be flat or conical. Preferably, the second 25 ove,layi"g layer of the sealing region can be displayed as a plurality of separate or inle~c4nn~~ d c~r~l-l-ic plates on top of the first underlying layer. Most preferably, the second o~e-la~ring layer is a plurality of S~)~dt~ plates on top of the first underlying layer. In this emboAiment~ when an i"sl,u",ent is inserted through the seal assembly, the ,~.g~nented nature of the overlaying layer minimi7~s its dero""alion 30 while the underlying layer between the separate plates, ~e~ifi~qlly chosen for its ability to deform, accepts the defolllla~ioll. In effect, the underlying layer in this prerel,l d embodiment actually affords protection of the overlaying layer.
Alternatively, the æcond overlaying layer may be a contin~ )c layer o~
5 molded on top of the first underlying layer.
The trocar of this invention has a æal assembly which æals against surgical instruments of varying ~ rnet~prs to ~ ;-- in~vrll;~lion in the body cavity during endosc~ic surgery. As of the filing date of this appli~tion~ surgical instruments with 10 ~ eh~ between 5-12 mm have convçn~inn~lly been uæd during ~nd~ s~pic surgery. Con~en~ly~ the æal asæmbly of the trocar of this invention can ~".""o~l~t~ the inærtion and withdrawal of instruments with ~ nlet~rs in this range.
In the current invention, the seal assembly can ~.. odate instruments within a wider or l~-u.._l range of ~li5' The trocar of this invention can be used in all of the surgical procedures wheretrocars have conv~ntiQn~lly been used or con~.llplalcd for use. Of course, the trocar of this invention is particularly adapted for e~ldoscQyic applin~tionc where it is n~ ~.y to insert i~ lllcn~ of varying .li~ t~ f through the trocar while still 20 ".~inl~;.,i.,g i-.~-rn~;O~ within the body cavity.
Brief Descripdon of the Dla~. il.FS
Figure 1 is a ~l~ti~e view of the seal ~ccPrnbly of the trocar of this 25 invention shown ;n partial cross-section.
Figure 2 is a pel~li~re view of the trocar providing access for a surgical instrument within a body cavity, where the seal ~cc~rnbly illustrated in Figure 1 is att~rh~A to the trocar.
- 21 9~2~0 Figure 3 is an exploded ~,~;li-/e view of the seal assembly illustrated in Figure 1.
Figure 4 is a pe.~ e view of the el~ctomeric seal COlll~nGn~ of the seal 5 ~Ccembly illustrated in Figure 1.
Figure S is a fr~grnent~ ye~ e view in partial cross-section of the e~ ...elic seal cr.~ e~-l as seen along view line 5-5 of Figure 4.
Figure 6 is an enlarged fr~gm~ry view of the el~ct~meric seal co~.lpol-P-~-t shown in Figures 4 and 5.
Figure 7 is a scl-e...-~ic top plan view of the seal assembly sealing against a surgical i--~hu~ ,nl as seen along view line 7-7 of Figure 2.
Figure 8 is a view similar to Figure 7 in which the instlul..h~l is of a larger t~ . .
Figures 9-15 are pe~ e views of alternate embo~limentc for the seal 20 ~c~mbly of the trocar of this invention.
net~iled Description of the ~lGrel,-,d Embodiments A plGfellGd seal assembly 20 for the trocar of this invention is illustrated in 25 Figure 1. The seal ~csembly is an integrated unit which is decigt ed to snap onto the houcin~ of the trocar c~nn~ It has a frame 21 which is sized to fit over the top of the cannula h~-~;ng. The frame has an GAt~,lior planar face 22 and an interior region 23 which is po5i~ioned within the cannula hw~ing The interior region includes a resilient latches 24 which secures the seal assembly to the h~lcing It also inrlu~Los a 30 neck 25 to f~rilit~tP the ~ nGe of surgical instruments through the r~nmll~ as they are inserted into and withdrawn from the c~nnul~ and to seal the assembly 20 ag~unst the outer gasket of the trocar to prevent the escape of gas around the frame 21.
The seal ~c~mbly depicted in Figure 1 has an el~rt~meric seal 26 to seal S against instruments which are inserted into and withdrawn from the c~nnul~ The seal is po~;tion~ centrally within the seal assembly. The seal incl~ldes a centrally pnCitinned a~cltul~ 27 to permit the passage of the inslru",en~. Adv~ntageoucly, the aperture has a ~ . et~ between about 2.5 to about 5 mm so it c~n seal not only ag~unst the cm~ p-st endoscQp.c i"sl~w"en~ but also 12 mm instruments and larger10 ones as well.
Referring to Figure 2, the trocar 28 of this invention is seen to provide accessfor the insertion for a surgical instrument 29 into a body cavity. The body wall 30 of the surgical patient is l)unct~lred with the trocar ob~ lor (not shown), and the15 oblur~ is subse~lPntly withdrawn from the cannula 31. The cannula has a houcing 32 with an interior ch~mh~r 33 (see Figures 7 and 8), and an elon~tP~ cylindrical sleeve 34 ey~n~ing from the houcing. The sleeve extends through the olxning madein the hody wall. At the pr~Ai."al end of the cannula houcin~, the seal ~ccPmhlly 20 is secured. A pas~ge..ay 35 is provided through the ~llur~; of the seal ~cc~Pmbly, into 20 ~e ch~mbp~r of the cannula h~llcing, and finally through the lumen of the tubular sleeve to provide a path for the insertion and withdrawal of a surgical instrument into the body cavity.
The c~",~onents of the plcfe.lcd seal assembly 20 are illustrated in Figure 3.
25 The frame is a su~c~mbly which has a top frame half 36 and a bottom frame half 37.
Sandwiched between the top and bottom frame halves is the el~lo...l . ic seal 26. The seal is position~Pd between upper and lower rigid rings, 38 and 39 ,e~ecli.~ely. The upper ring has a plurality of prongs 40 which are fitted through the seal and are received in a plurality of receiving holes 41 in the lower ring. The top and bottom 30 frame halves define an internal cavity 42 for receiving the seal 26. The top frame half 21 952~0 g has a circular opçning 43 sized to fit an insll~",en~ with the largest ~la~fst~rcontemplated. -Co~ sl.o~ ngly, the bottom frame half h s a similarly sized opfning 44 which is filnnf le~ to form the neck 25 of the se. l qc~mbly. A det. iled d~ lion of a seal qcc~mbly with similar coll-poncn~ is described in U.S. Patent No. 5,342,315.
Referring now to Figures 4-6, the seal C~ f~ 26 of the prcr~ d se~
qc~embly is illustrated. The se~ is made of a medical grade el~Q~omer. ~wliples of suitable cl-r~....e.~ include, but are not limited to, silicone rubber, polyurethane elqrt~mer, chlorobutyl rubber, latex rubber, polyisoprene rubber and ethylene 10 p~c~yl~ diene monomer (EPDM") rubber. The plere.l~ el~ nc~ are silicone rubber and l)O!yu~ f rubber. The most plefcll~d el~ct~lmer is meA:--ql grade cili~ne, for e~lll)lc, Dow Corning Slastic~ brand medical grade silicone rubber.
The seal has inner and outer portions, 45 and 46, ~i,~e~ti-rely. The inner and 15 outer portions are divided by the upper and lower rigid rings. The outer portion of the seal has a bellows c~ nfi~ ion, As ~ se~ in U.S. Patent Nos. 5,073,169 and 5,209,736, the bellows facilitates the ...G;u~ ~nce of a seal during radial motion of surgical h~stlull,cnls which are inserted into and withdrawn from the c~nmll~ The inner portion of the seal has a centrally located interior region 47 which c~n~;..C the 20 d~-tUrc 27 for passage of the surgical instruments. The circumferential surface of the aperture seals against ir,~tlulllc.l~ because it provides the surface against which the i~l~ulllhlt~ come into contact. A sealing region 48 is c4--ceulr;c~11y located about the interior region of the seal. It is this sealing region which SUppOll~i the aperture 27 of the interior region of the seal ~c~embly when instruments are inserted and withdrawn, 25 and l,l.,._n~s or minimi7es the escape of il.~urll~lion gas from the body cavity through the trocar c~nn~ . Accordingly, the seal region must have the dual propellies ofela~lici~y to enable the passage of large instruments through the aperture 27, and toughnecc to prevent ripping when misaligned instruments are forced against the sealing region.
Signific~ntly, the sealing region has two layers. It has a first underlying layer 49 located interiorly towards the surgical patient, and a second overlaying layer 50 positioned on top of the first layer. The two layers are integral with each other to create an integral l~min~tP. The l~min~tP of the e~ mer can be made using 5 convPntion~l inie~tion co-molding techniques which are well known in the art. In other words, the first underlying layer of the el~ct~mçr is initially molded, and then the second ove,layil-g layer of the el~-h,~,-cr is subsP~çntly molded on top of the first layer to create the integral laminate. The underlying layer is elastic so that the ape,nl,c will stretch in ~ ~nse to instrument insertion, and the ove,la~ g layer is 10 tear r~;~ll to prevent ripping. Accordingly, the tear ee~;c~ re of the overlaying layer is adv~nt~gPouc1y greater than that of the underlying layer.
Generally, the specific tear strength chosen for the underlying and overlaying layers will depend on the degree of rÇcict~nce to seal tearing desired, which 15 co"~ ondingly ~iepen~c on the size of surgical instruments inserted into and withdrawn from the trocar cannula and the shape of the end effe~ of these instruments. In ~ litinn, the tear strength will also depend on the particular confi~..dlion of the e~ .n~-ic seal. For example, a seal which has a confi~-ration with a large surface area to f~ilit~te e~ o~ of the seal a~llu,l may need less tear 20 strength than a seal with a confi~-ration widl a small surface area. The,efole, the specific hardl.ess for the underlying and overlaying layers may be readily determined e.--~,i,icdlly. Nevertheless, the first underlying layer of the el~t~mer in the sealing region of the sealing ~c~mbly preferably has a hardness belw~-- about 5 Shore A
D~lr~...eter Scale and about 40 Shore A Durometer Scale. The second overlaying 25 layer has a hardl,ei,~ which is p,efeldbly between about 40 Shore A Durometer Scale and about 80 Shore D Durometer Scale. The har.h-ejs of the el~ct~m~r can be determined using the standard test method for harJI-ess of the thermoplastic el~ctQmers set forth in ASTMD 2240 91.
21 952~0 Overall, if the hardness of the first underlying layer is less than about 5 Shore A Durometer Scale, then the underlying layer may become very adherent or "sticky"
to the h,~ ellt inserted through the seal assembly, con~quçntly causing high friction and leading to the possible tearing of the seal assembly. Coll~ ~n~ingly~ if S the hal~less of the first underlying layer is greater than about 40 Shore A D~llu~ r Scale, then the underlying layer becomes h~cr~as;llgly stiff, minimi7ing the fleYibility or e1ong~ion of the layer which may cause the possible tearing of the layer or an incr~ in instrument insertion force. If the second overlaying layer has a hardness less than about 40 Shore A Durometer Scale, then there is the potential for incr~d 10 friction and surface contact belween the instrument and the seal which may cause tearing of the seal ~ccPmbly. Coll~ ondingly, if the second overlaying layer has a hardl,ess greater than about 80 Shore D Durometer Scale, then there is the poLenlial for the shearing of the first underlaying layer upon instrument withdrawal which may cause tearing of the seal ~c~mbly. Also, a harJI~ess greater than 80 Shore D
15 Durometer Scale minimi7~s the elastic flexibility of the overlaying layer, thus ~t~lllially inhibiting tissue removal and causing instrument snags. Preferably, the first und~llying layer of the sealing region of the sealing assembly has a hardness l;.,h.~n ahout 30 Shore A Dulullleter Scale and ahout 40 Shore A Dululll~r Scale.
The second overlaying layer of the sealing region pl~;fe...bly has a tear recict~n~
20 between about 50 Shore A Durometer Scale and about 80 Shore D Durometer Scale.
Most preferably, the second overlaying layer has a tear resist~nce between about 60 Shore A Durometer Scale and about 70 Shore A Durometer Scale.
The sealing region of the seal assembly depicted in Figures 4-6 is confi&llred as 25 a shallow cone. The overlaying layer of the co-molded integrate l~minate is displayed as a plurality of sep~dt~ rP~"~ic plates 51 in the form of l~uncaLed triangles.
Figures 7 and 8 depict the insertion of surgical instruments of varying ~ meter through the trocar cannula 31, and the seal which is created between the instrument 29 30 and the sealing region 48 of the seal ~c~mbly 30. As the insl,~menl is inserted 21 5528~
through the a~,ture of the seal, the aperture e-~r~n~C to ~r~l.. o~te the outside I~iA~llel~r of the i.ls~ n~ in erted through the seal.
Referring briefly now to Figures 9-15, there are illustrated alternative S en bo~limpntc for the confi~,..alion of the seal co.l.ponenl 26 of the seal assembly for the trocar of this invention. Figure 9 depicts a second overlaying layer of the sealing region 48 as a plurality of i.,t. ,.~ -fcled c4l-rf~ .ic plates 52. Figure 10 illustrates the second ov. .l~;"g layer region of the sealing region a a c~ntinuouC layer 53 co-molded over ~b~nti~lly the entire surface of the underlying layer. In Figures 11-13, 10 the sealing region of the seal ~csembly is c~nfi~lred as a flat seal instead of a shallow cone. Alternatively, the sealing region can be c~nfi~lred as a deep cone a shown in Figures 14 and 15. In the embor~ pntc of Figures 14 and 15, the outer portion 46 of the seal del)ic~l in Figures 4 and 9-13 have been çlimin~tPA
In another embodiment of this invention, the seal assembly may be insert molded directly to the interior wall of the cannula h~ usin~ of the trocar instead of the latch "1. rl~ U~ ctm~-i in Figures 1 and 2. For e~..~,'e, the cannula h(u-cing c~n be initially inserted into a mold. The first underlying layer of the sealing region of the seal ~csembly can be injected into the mold to form the outer pe,i...et~r of the seal as 20 well as to form a . .c~l,Al-ir~l interlock with the cannula hollcinE. Sub~ently, the second o~ lla~ ;ng layer may be co-injected into the mold. Once the e~ is fully cured, the cannula h~llsing can be ~emol~le~
~lthMl~h this invention has been described in co~,-e~liQn with its most 25 I)refe"cd e-mbo l;...c~ , n.~ el.)us ~l~iti- n~l embo~imrntc can readily be contemrlated by those skilled in the art and lllc,tfo-c fall within the sc~pe and spirit of the cl~imed invention. The detailed desc~iy~ion of the pr~fc,-ed çmbo limrntc are exemplary only, and should not be construed in any way to limit the scope of thecl~imçd invention.
Claims (11)
1. A trocar for providing access for insertion and withdrawal of surgical instruments to and from a surgical site within a body cavity, said trocar comprising:
a) a trocar cannula, said cannula having a cannula housing and a tubular sleeve extending therefrom, said cannula housing having a passageway communicating with said sleeve so as to create a path through said cannula for providing access for insertion and withdrawal of said surgical instruments; and b) a seal assembly affixed to said cannula housing in said path of said passageway, said seal assembly including a seal composed of an elastomeric material for sealing against said surgical instruments of varying diameter, said seal having a centrally located interior region containing an aperture therethrough, and a concentrically located sealing region, wherein said sealing region comprises an integral laminate co-molded from said elastomeric material, said laminate having a first underlying layer and a second overlaying layer, said first underlying layer having a hardness between about 5 Shore A Durometer Scale and about 40 Shore A Durometer Scale, and said second overlaying layer having a hardness between about 40 Shore A
Durometer Scale and about 80 Shore D Durometer Scale.
a) a trocar cannula, said cannula having a cannula housing and a tubular sleeve extending therefrom, said cannula housing having a passageway communicating with said sleeve so as to create a path through said cannula for providing access for insertion and withdrawal of said surgical instruments; and b) a seal assembly affixed to said cannula housing in said path of said passageway, said seal assembly including a seal composed of an elastomeric material for sealing against said surgical instruments of varying diameter, said seal having a centrally located interior region containing an aperture therethrough, and a concentrically located sealing region, wherein said sealing region comprises an integral laminate co-molded from said elastomeric material, said laminate having a first underlying layer and a second overlaying layer, said first underlying layer having a hardness between about 5 Shore A Durometer Scale and about 40 Shore A Durometer Scale, and said second overlaying layer having a hardness between about 40 Shore A
Durometer Scale and about 80 Shore D Durometer Scale.
2. The trocar of Claim 1 wherein said elastomeric material is selected from the group consisting of silicone rubber, polyurethane elastomer, chlorobutyl rubber, polyisoprene rubber and ethylene propylene diene monomer ("EPDM") rubber.
3. The trocar of Claim 2 wherein said elastomeric material is polyurethane or silicone rubber.
4. The trocar of Claim 3 wherein said elastomeric material is silicone rubber.
5. The trocar of Claim 1 wherein said first underlying layer of said sealing region has a tear strength between about 30 Shore A Durometer Scale and about 40 Shore A Durometer Scale.
6. The trocar of Claim 5 wherein said second overlaying layer of said sealing region has a tear resistance between about 60 Shore A Durometer Scale and about 70 Shore D Durometer Scale.
7. The trocar of Claim 1 wherein said second overlaying layer of said sealing region is displayed as a plurality of separate concentric plates.
8. The trocar of Claim 1 wherein said second overlaying layer of said sealing region is displayed as a plurality of interconnected concentric plates.
9. The trocar of Claim 1 wherein said second overlaying layer of said sealing region is a continuous layer co-molded over substantially the entire surface of said first underlying layer.
10. The trocar of Claim 1 wherein said seal is generally a flat seal.
11. The trocar of Claim 1 wherein said seal is a conical seal.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/588,850 US5628732A (en) | 1996-01-19 | 1996-01-19 | Trocar with improved universal seal |
US08/588850 | 1996-01-19 |
Publications (1)
Publication Number | Publication Date |
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CA2195280A1 true CA2195280A1 (en) | 1997-07-20 |
Family
ID=24355559
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002195280A Abandoned CA2195280A1 (en) | 1996-01-19 | 1997-01-16 | Trocar with improved universal seal |
Country Status (5)
Country | Link |
---|---|
US (1) | US5628732A (en) |
EP (1) | EP0784961A1 (en) |
JP (1) | JPH09308637A (en) |
AU (1) | AU1015297A (en) |
CA (1) | CA2195280A1 (en) |
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1996
- 1996-01-19 US US08/588,850 patent/US5628732A/en not_active Expired - Lifetime
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1997
- 1997-01-13 AU AU10152/97A patent/AU1015297A/en not_active Abandoned
- 1997-01-14 JP JP9015982A patent/JPH09308637A/en active Pending
- 1997-01-16 CA CA002195280A patent/CA2195280A1/en not_active Abandoned
- 1997-01-17 EP EP97300272A patent/EP0784961A1/en not_active Withdrawn
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JPH09308637A (en) | 1997-12-02 |
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