CA1297363C

CA1297363C - Medical instrument valve

Info

Publication number: CA1297363C
Application number: CA 575824
Authority: CA
Inventors: Richard A. Hillstead
Original assignee: Cordis Corp
Current assignee: Cordis Corp
Priority date: 1987-09-21
Filing date: 1988-08-26
Publication date: 1992-03-17
Anticipated expiration: 2009-03-17
Also published as: EP0308815A3; EP0308815B1; JPH01139077A; JP2729384B2; EP0308815A2; US4895565A; DE3850726D1; DE3850726T2

Abstract

MEDICAL INSTRUMENT VALVE

Inventor: Richard A. Hillstead ABSTRACT OF THE DISCLOSURE

A hemostasis valve is provided for catheters or the like, comprising an elastomeric partition valve secured in a housing. A linear slit extends through the partition valve between the major faces thereof. By this invention, the partition of the valve has at least one concave face through which the slit extends. Such a partition valve provides further improved sealing characteristics over a wide range of diameters of catheters, leads, or the like penetrating the partition valve, particularly reducing frictional resistance to catheter advancement and rotation through the valve and also reducing catheter collapse in the valve.

Description

~2~63 BACKGROUND OF THE INVENTION

Hemo3t~sis valves are well-known, being curren~l~ u~d, fsr example, on catheters for performing percutaneou tran~luminal coronary angiopl~s~y (PTCA) ~9 well as anglographic procedures, for example where x-r~y contr~st fluid iY insert~d into ~he coronary ~rtery. He~o~tasla Y~lYes ~re al90 used to prevent the leak~ge of blood out of the ends of dilitation and guid~nce catheter~, to preYent the seepage of blood between the guide wire and the dilit~tion c~theter, and al90 between the two catheters.
Numerous ~ypes of hemosta~iq val~es ~re known, br way of example, ~ee Stevens, U.S. P~tent No. 4,000,739, Matsumo~o et al, UgS. P~tent No. 4,610,6~S, ~ad Weinsteln U~S. P~tent No.
4,626~245, Hemo~tasl~ vslYes may also be e~plo~ed for the lntroductlon of other cstheter3 into the circula~ory s~a~eo or elsewhere ln a lesk-proof manner. The ~81~e ~7 be carrled by any cbtheter or ~heatb introducer, to per~it an ~nner cstheter, probe, or th~ like ~o be pl~ced ~hrough ~he bemo~t~ vcl~e to form a le~k-proo~ ~al snd ~ port of entry.
In ~ccord~nce with thi~ lnYention, ~ hemost~sis v~l~e ~8 , pro~lded which exhibit~ slgnificantl~ improved toler~nce for ~rying di~meter~ of catheter~ probe~ ad~ or the like penetrating it wi~hou~ leaksg~ or da~e to ~he v~lve, Wh~le the valYe of this inYentlon exhibits impro~e~n~ b~ reducing sliding and ro~ational re~i~t~ce for ~lon~ated ob~ect~ such a~ cathet~rs as they pa~ thr~ugh the ~lve, th~ stlll provide good re~istance to dislodgement of ~uch a csthet~r ~fter it ha~ been prop~rly positioned. S~ rly, reduced c~pression on the cstheter or other elongated ~e~ber i~
noted within the valve of this invention, per~itting gr~ater facility in the uqe of multi-lumen catheters, for exa~ple, and ~oiding collapse of thin-wal~ed catheters at ~he point where they extend through the ~al~e. Ne~er~hele~s, the hemo~t~is val~e of thi~ invention still e~hibltq exc~llent pressure handling cap~bilitieY, to pre~e~t leakage under pre~ure, whether or not ~n elong~ted obJect ~ 8 p~sing thro~h the ~ e of thl~ inYention.

D~SCRIPTION OF THE INVENTION

One aspect of this invention relates to a hemostasis valve ~hich may be used for preventing backflow of blood or : other fluids through a catheter or the like, while permitting passage of a probe, an inner catheter, an electrical lead, or any other elongated member through the valve. As is conventional, the valve comprises an elastomeric partition member having opposed major faces, the partition member being secured in a housing. A linear Rlit extend~ through the - -i ,. 1 ~, ...

`~ 7363 partition ~ember between the major faces thereof.
In accordance with this invention, at least one of the major faces defines a concave surface to reduce the central thickness of the partition member. The slit extends through the concave surface. The slit further defines a first line on one of the major faces and a second line on the other said face. The first and second lines have a similar configuration but are in non-alignment with each other, with a generally helical slit section extending between the first line and the second line through the partition member. Preferably, both of ~he major faces of the partition member are concave in shape.
The effect of ~hl3 to reduce the thickne~ of th~

elsstomeric material ~round the slit, which ha~ ehe effect of reduclng the frictional re~i~t~nce s8ain~t ~ catheter pa~81n~
through the sllt or rotating therein. Additionall~, the oYer~11 inwurd pres~ure exerted on the cstheter by the elsstomeric material of the p~rtltion, at the point where the catheter penetr~tes ~t, i~ reduced, whlch per~lts the u~e o thinner walled catheters, when c~mpared with equi~lent pa~ti~ion members of the same de~i8n which do n~t ha~e conc~ve ma~or facea.
Not only i9 there be~ter lubricity or slid~n8 feel of the catheter as it i~ ad~anced and retracted ehrou8h ehe pareition me~ber, but the torqu~blllty or ro~tlon~1 sesl~t~nce 13 reduced for oathet~rs whlch ~re ~o be rot~ted for steerin~ purpo~es or the like.
AY a further adv~ntage, the ~al~e of thi~ in~ention with concave-faced p~rtition~ i9 ~omewhat aelf-co~pen3~t~ng in that n catheter of larger outer tla~eter will encounter at it~ outer edge more material of the p~rtition membsr as a con~equence of the concave shape o~ the fac~ or face . Thu~, l~rger c~theter~ wlll encoun~er a ~tronger s~al f 8reater khickne3s aQd m~sa at the J~nctio~ be~een th~ o~r dia~eter ,, ~2~73~3 of the catheter flnd the m~terlal of the partition me~ber 8bout the 91it9 which i9 deemed desir~ble ln ~09t circumsta~ces. As an ~dditional ad~nt2ge, the periphery of the p~rtlt~on member is thicker than cen~r~l portion~ becsu~e of ~he concAve sh~pe of the m~Jor face or f~ces~ ~o ~h~t the partition can be firmly secured in a p~ripher~l pre~sure ~eal, despite the thinner nature of the c~ntral pOftiO~.
As noted above, the slit defines a first line on a first major face and a second line on the second major face of the partition member. The first line and the second line each havè a similar configuration which may be a branched configuration, but are in rotational non-alignment with each other. A generally helical slit section extends between the first line and the second line through the partition member. Such a design of slit has been found to provide improved sealing characteristics over a wide range of catheter diameters (or diameters of other elongated members passing through the hemostasis valve).
Additionally, a self compensating lubricity is provided, possibly caused by a sliding "iris" effect inherent in the spiral design of the slit preferably used in the hemos~asis valve of this invention, to permit easy insertion and withdrawal of elongated members through the valve.
Nevertheless, the structure provides sufficient gripping action so that elongated members are not easily dislodged by unintentional means.
Additionally, the design of slit in the valve of this invention provides reduced compression on multi-lumen or ~9'73~3 thin-walled catheter~, aa well a~ improved resiatance to l~akage under circum~tance~ of hi8h pres ure while 2Yoldlng c~theter collapse. The valv~ of this in~ention is eas~ly manufac~urPd for 3ignificant improvements in the performance S of hemo3tasis v21Yes for the above r~son~ ~nd other~ as well.
Preferably~ the ~bove described line at e~ch ma~or face of the parti~ion member defines a plurality of intersectin~
radii, typically thr~e, the radll belng preferably cub3tantislly equiangularly spaced to each other on esch f~c~. TheRe radii are non-sligned (i.~., the~ def~ne an angle) with corresponding radii on the oppo~ed m~or face, with the respective, corresponding, opposed radii on oppo~ed m~jor face~ definln~ a plurality (typically thrse) of the helical slit Rections betwee~ them, the helic~l slit ~ections being in generally coaxial relation to one ~noth~r.
Typic~lly, the re~pecti~e line~ or radli on ~he opposed major faces which sre connected to esch other b~ ~ h~lical slit 3ection define an ~n~le of 10 to 180 d~grees or more.
Preferably thl~ sngle i~ 30 to 90 degrees~ mo~t prefersbl~
sbout 60 degree~.
The housing and el~tomerlc p~rti~ion ~a~ be of ~ny conventional design in which the hou~lng holds the ~lHstomerlc partition about it-~ ~dges, 50 th~t the centr~l portion of the ma~or f~ce~ cre exposed for ~ce~s~ b~ 8 catheter~ a probe, or the like or pa~sge therethrou~h.
The elasto~eric partition member msy b~ B 81~plo dl~c o~
na~ur~l or synthetic late~, or an7 othor desirod ~ls~o~er which generally h~ sufficient r~silience, ~ypie~lly in th~
ran8e of 30 to 50 Shore "A" Durometer. Intere~tin~
inherently good needl~ rese~lability ~ay not neces~srily be a critical charact2ristic for ~ good ma~erial u~ed ~8 the elastomeric partition ~al~e in this invention. For example~
silicone rubber, especi~lly silicone rubber maeeri~l~ h~n8 sn i~pregnated amount of free silicone fluid (e.g.
di~ethylpoly~ilox~ne prefer~bly pre~ent i~ an ~ount of 2 to lO weight percent) may desirAbly be u~ed, ~lthough Auch la not often u~ed as a ne~dle-resealable barrier. The free silicone fluid oan ac~ ~9 a lubric~nt th~t facilit~es the sdvantages of ~his invention. Other ~lastomer~ and other impregnated fluid lubricants may al80 be u~ed.
As one manuf~ctures the partition member in accordsnce with this invention by cutt$ng ~ slit ~hrough it, one may rotate the cuttlng bl~de ~or the Yal~e) during th~ cuttlng proces~ ~o that the blade a~ its entry point on one ms~or : faoe defineY an angle wlth itself at lts exit point on the ~ . other ma~or ~ce~ to pro~ide ehe desired helieal slit aA
: 20 described abo~e.
; The cu~ting blade msr be of ~he de~lred helical shspe~
bein8 rotated as it cut~ through the elastomeric partition Yal~e, but ~tr~i8ht blad~a, perp~ndlcular ~o the pl~ne o~ tho psrtition ~alYe, can al30 be e~sil~ uoed because of the ela~tomerlc n~ture of the p~rtition ~ember. Speciflcally, th~ ahapo o ~he bl~do at it~ euttlng ~d8e will b~ idant~e~l to the ~h~pe of the ~lit at each ~a~or ~ace. Thu~, prefer~blr~ th0 blHde ~aJ also co~prl3~ ~ plurall~y of ~3~;3 intersecting r~dial edge~, particularly three int~r~ectin~, ~ub~tantially equ1ang~ rly spsced radial edges, to def~ne - ehe preferred ~lit p~ttern. Then, the radially edged blade~
pa~3 throu~h the ela~tomeric valve with rot~tion to for~ the desired ~ngle between the l~neq or r~dii at ~ach msJor ~aCQ
a~ de~cribed AboYe. It 1~ generelly preferred for 8 ~llt haYing a cro~s section of chevron ~hape, or ~ sh~p~ of two to six substantially equiangularly 3paced radii fro~ a com~on origin, to be u~ed. However 9 it 18 not ~snt~tor~ for the r~dii to be equla~ular in their ~p~clng.
Also, other ~lit desi8ns may be uqed ln acc~rdsnce with thi3 lnYention as may be deslred. For example, a slit desi8n a3 covered by Weinstein U.S. Pa~. No.
4~626,245 may desirsbly he used, or any other known slit configuration for the partition member of a 31it-eype p~r~itlon Y~l~e.
After the ~lit h~s been formed by cuttlng in~o ~he ela~tomeric partition member of thls in~entlon, it may be ~ou~ted into ~ houslng in con~ention~l ~anner~ carrled if deslred on ~ c~th~ter or ~he like for u~e. See the abo~e ; clted patent~, 8~ well ~s other kno~ technolog~ for con~ention~l housi~g d~i8na qnd th~ lik~.
Other aspects of the invention concern a catheter sheath including an elastomeric partition valve, a medical instrument incorporating a valve which includes an elastomeric partition member, and a method for making an elastomeric partition valve.
D~SCRIPTION OF TH~ DRAWINGS

In the dr~wing~, Fi8~ 1 i8 a per~pectlvo ~lew~ ~ith p~rtion cut 9~y; ~f ~ c~th~eer whlch c~rio~ the ho~o~taol~
~al~ D~ thls ln~entlon~

~2~'73~;~
Fi~. 2 is an enlar~ed, pl~n ~iew of the partltion me~ber u~ed in the he~o~ts~iQ ~alve of Fig. 1 showing ~ preferred slit p~ttern i~ the el&stomeric p~reitlon member.
Fig. 3 i~ a per~pecti~e view of the elastomerlc partition member of Fi~. 2, ~howin~ the .~lit p~ttern.
Fig. 4 i~ a tran ver~e ~ectional view eAken along llne 4-4 of Fig, 2.
Fig, 5 is ~ per~pective view of the ela~tomerlG
partition member o~ Fi~. 2.
Fi8. 6 i~ a psrti~l per~peo~i~e view of ~ de~lce for cutting the preferred slit pattern into ~n elas~omeric di3c.
Fig. 7 i8 a section~l view taken along llne 7-7 of Fig. 6.

. DESCRIPTION OF SPECIFIC EMBODIMENT

Ref~rring to the drAwin~s~ Flg. 1 ~hows a catheter sheaeh introducer lO, ~d~pted to receive an inner c~theter 12 ~ shown for inser~lng into the Y~sculsr 3y~te~ uE ~ p~tlent.
Catheter she~th introducer 10 i3 usod to introduoe a c~theter lnto 8 blood vea~el while preventing blood backflow along the outside ~urf~ce of the catheter during procedures in whieh c~theter i9 in~erted into ~he ve3sel. Current deslgn~ of catheter sheoth in~roducer~ are typlcOEll~ limited to a narrow ranS~ of only one or two Fr~nch size~ o lnnor c~th~ter 12 for which they c~n provide e~fecti~e entr~ ant ~e~ling, ~hile permltting inner c~theter 12 to remaln lubriciDus b~ not removing too ~uch lubric~nt from ~. Thi~ ~itu~tioo i8 ~2~37363 improved by ~he invention of the pre~iou~ly cited U.S. Patent No. 4,626,245. However, in accordance w~th ~his in~ention, further improvements relatlng to size toler~nce o~ the Y~l~e of thi3 invention are provided~ along wi~h the o~her adYantages as described abo~e.
Catheter 6hesth introducer 10 deflne~ outer tubular hou3ing 14 which carrie~ csnnula portion 16 of caeheter sheath introducer 10, po~itioned in attached, telescoping relation with tubular pro~ru~ion 18 of tha hou~in~. Side port 20 may b~ of con~entional design9 being ad~pted for tele3coping c~nnection with plastic tubing 22, for pro~lding a sallne solution for flushing the interior of houaing 14 and tubing exten31~n 16.
Housin~ 14 also c~rrie~ self-sealing penetr~ble barrier a~ el~stomeric partition valve member 24, which ~ay be made of an approprlate ela~to~eric material. For exa~ple, natural rubber latex i~ well-known for providlng excellent resealing ch~rActeri~tlc~ However, ~llicone elastomer~, fluoropolymer~, poljurethane elasto~ers, or an7 other elastomeric msterial may be used, depending upon the perform~nce p~rame~er~ de~ired, eapecially wh~n the~ c~rr~
impregnating lubricating sil. Prefer~bly an oll-l~pregnat~d ~illcone rubber of Duro~eter 40 ms~ b~ u~Qd.
~ouain8 14 ~8y co~pri3e c~lng portions 26, 28 which are sealet together ln teleacopic rel~tlon ~nd whlch perlpherally capture penetr~ble barri~r 24 between the~ hown.
Altern~t~Yely~ c~ing port~on 28 may be ~ 8cre~ C~p, for sd~u3t~ble eoQpre~si~e reten~ion of ela~to0~rle ~rrl~r 24.

.; , .

'73~3 Annular rib~ 30, 32 msy be provided in e~ch hou~ing por~ion to provide ~or~ positive eapture of the elagtomeric por~lo~
24.
Referrin8 to Fig~, 2 thru 5 9 det2ils of the sllt desi8n in p~rtition member 24 are d~closed. Specifically, the cros~-section~l sh~pe of sl~ e 40 i9 of th~ ~hape of ~hree, interseoting, sub~tantially equiangulsrly ~paced radii 42, 44, b6, sp~ced about origin line 48 by about 120 degree~, snd defined on ma~or face 50. ~ltern~tiYely, wlth four equiangularly spaced radii, the included angle between each radius iB 90 degrees. S~x spaced rsdii ~8y defioe lncluded ~ngles of 60 degree~. Two equ~angularly spaced radii d~fine sn included angle wlth esch other of 180 degrees, and thuq deflne a single, str~ight line, for a ~implified version of the inventlon of ehls application.
On major ~ace 52, on the other side of partition member 24, slit 40 defines a ~ubstantislly identical cross-section of three, intersectlng, sub~tantially equi~ngularly spaced radii 547 56, 58, with re~pec~ive helical slit sections 60, 62, 64 de~ined between the re~pective radii on opposed faces 507 52 through the material of p~rtition ~ember 240 A~
s~ted before, ~uch ~ ~llt can be proYided by a knife of corre~ponding cross-~ectisn~l sh~pe which m~y have sngled, or helical blade3 if desired, and which ~ay be rot~ted aa ehe blsde~ cut throu~h par~ition member 24. Speciflcally, the ~otal angl~ of cutting rotation shown i3 ~bout 60 de8ree3~ ~o that each radlu~ 42, 44, 46 on surface 50 defines a~ angle of ~bout 60 de~ree~ ~o e~ch radiu~ 54~ 56, 58 on surface 52 of ~L2~3~3 partition member 24. Preferably, the angle of cuttlng roestion increa~e~ linearly ~8 cutting progre~se~. For exsmple, if the to~al cutting angle i8 60 de~ree~, at one-quarter depth from ~urface 50 the blade~ have rotated 15 de8ree~; at one-half o~ the depth between s~rfaces 50 snd 52 the blade~ h~e rotated 30 degrees, ~tc.
Figs. 6 and 7 3how app~r~tus for punchlng a ~lit ia accordance with this inYention into a partition val~e 24.
The silicone r~bber disk (containing impregnated qillcone oil) that i~ to become parti~ion member 24 mar be mountet in a ~ig 60, or otherwise ~ounted between casing portion~ 26, 28 on A catheter or ehe lik~. Triple-flnned blade 62 i9 brought a8~in~t the di~k, whlle rotating a~ shownO Blade 62 i~
ad~anced through the opposed, msjor ~ce~ 50, 52 of the di~k, being rotated by about 60 de~ree~ as it ad~ances be~we~n faces 50, 52, to cut the de~lred slit. Then, blsde 62 i~
wlthdrawn from the newly-formed psrtltion ~al~e member 24.
Origin llne 48, ~ well as helical 811~ 60, 62, 64, extend entirely through par~ition membsr 24 in 8 ~Bnner contrary, for exemple, to the dlsclosure oP U.S. Patent No.
4,626,245. When a ca~heeer 12 or other elongat~d ~e~ber i~
passed throu~h parti~ion vsl~e member 24, it p~s3e~ easil7, with 2rea~ ~olerance~ ~8 to deYia~ions in di~met~r of catheter 12D yet wlth good ~eallng retention of partit$on member 24 sbout catheter 12, ~nd low cath~ter coll~p~ln~
pressur@ exhibitlng the ad~nts8e~ describ~d ~bo~e.
In accordanee with thi~ inventlcn, bo~h ~ld~s o partition me~ber 24 d~ine eentral, csnc~v¢ portions 71~ 73.

3~

The entire helical ali~ occupie~ both concave portion~, ~o thst the thicknes3 of the material through which th~ helicsl slit penetrates i9 les~ than the thickness of the Materi~l 3t peripheral portions 75 of partltion 24. Specifically9 partition member 24 msy ha~e a dlameter of 0.3 inch, while the ooncs~e portion~ 71, 73 m~y esoh ha~e 8 diameter of 0.12 inch, each of the concaYe portion~ bein8 in concentrlc rel~tion with partitlon 24. Partition 24 ~a~ ha~e ~ ~xl~um ehlcknes~ of 0.07 inch, with the tepth of esch eoncs~e ares 71, 73 being a~ particularly ~hown in Fl~. 4. Preferably, each conc~e area defines a sub t~nti~lly spheric~l section.
Thus, the concave faces defined in ~alve member 24 provide easier catheter manipulstion through the ~al~e, as well a~
less opp~rtunity for collap~e of the thin w~lled catheter which penetr~t~ the Ysl~e, as described above, When compre~sed, as by retentlon in ehe hou3ing, the radlal lines of the slit on the ma~or f~ces of the p~rtition Yalve m~y form ~rc~ e~en though the orlginal, cut lin~ are ~tr~igh~, due to compre~sive 0rce3 in the elastomerlc ~al~e. It follow~ that ~he orlgin~l 7 cut lino~
on the m~or face~ msy be ori~1nall~ curYed, i~ dasired.
In the~eleceion of a de~ired cro~s-sec~lonal shspe for ~llt 40 of thi~ inYention, the resi~t2nce of th~ ~al~e to leakage of pres~urizet fluids will eend to increAse ~8 the angle 3ubtended by the helical slit ~ectlon~ incre~e~. In oeher words, sn an~le of 180 de~ree~ bet~eon corre~pondlng llne~ on oppo3ed faces of psr~ltion ~eobor 24 (and th~t much twlot provlded to the ~e~pec~i~e hellcal.311t ~ectlon ) ~ill tend to provide more seslin~ capabilltg than a significantlg lesqer angle.
Similarly, the ~eallng power of partition ~ember 24 will tend to increa~e wlth a reduction in the number of r~dii present in the ~lit cross~section. A ~trai~ht line slit can therefore provide excellent se~ling, especlally when the helic~l secti~n presene twist~ by 60 degrees or more.
The sbove has been offered for illu3trativ~ purpose~
only, 6nd i~ not intended to limit the scope of ehe invYntlon of this application, which is a~ defined in the clsim3 below.

'

Claims

1. A valve which comprises an elastomeric partition member having a first face and a second, opposed face and adapted for securement in a housing, and a slit extending through said valve between the first and second faces, the improvement comprising, in combination:
at least one of said faces defining a concave surface to reduce the central thickness of said partition member, said slit extending through said concave surface, said slit further defining a first line on said first face and a second line on said second face, said first line and said second line having a similar configuration but being in non-alignment with each other, with a generally helical slit section extending between said first line and said second line through said partition member.

2. The valve of claim 1 in which both said first face and said second face define concave surfaces between which said slit extends.

3. The valve of claim 1 in which said slit defines on said first face a first plurality of intersecting radii and on said second face a second plurality of intersecting radii, with said first plurality and said second plurality having a similar configuration but being in non-alignment with each other and with generally helical slit sections extending between said first plurality and said second plurality.

4. The valve of claim 3 in which the included non-alignment angle is between 10 and 180 degrees.

5. The valve of claim 3 in which the included non-alignment angle is essentially 60 degrees.

6. The valve of claim 3 in which said first and second plurality each define three intersecting, substantially equiangularly spaced radii.

7. The valve of claim 1 in which said partition member carries an impregnated lubricating oil.

8. The valve of claim 1 in which said partition member comprises a one-piece unitary member formed of silicone rubber.

9. A catheter sheath introducer including a housing, said housing including an elastomeric partition valve having a first major face and a generally parallel and opposing second major face, and a slit extending between said first and second major faces, the improvement comprising, in combination:
at least one of said faces defining a concave surface to reduce the central thickness of said partition member, said slit extending through said concave surface, said slit also defining a first plurality of intersecting lines on said first major face and a second plurality of intersecting lines on said second major face, said first plurality and said second plurality having a similar configuration but being in non-alignment with each other, with generally helical slit sections extending between said first plurality and said second plurality.

10. The catheter sheath introducer of claim 9 in which both said first face and said second face define concave surfaces between which said slit extends.

11. A catheter sheath introducer as described in claim 9 in which the line at each major face defines three intersecting substantially equiangularly spaced radii.

12. A catheter sheath introducer as described in claim 9 in which said partition valve comprises a one-piece unitary member carrying an impregnating lubricating oil and being formed of silicone rubber.

13. A valve which comprises an elastomeric partition member having opposed major faces and secured in a housing, the improvement comprising, in combination:

a slit extending through said partition valve between the major faces thereof, said slit defining a line at each major face, the respective lines at said opposed major faces defining an angle to each other, said slit defining a least one generally helical slit section between said lines on the major faces and within said partition valve, at least one of said major faces defining a concave surface to reduce the central thickness of said partition member, said slit extending through said concave surface.

14. The valve of claim 13 in which both of said major faces define concave surfaces between which said slit extends.

15. The valve of claim 14 in which said slit defines a line on each major face comprising a plurality of intersecting radii, each plurality of intersecting radii on each face having a similar configuration but being in non-alignment with each other, and with generally helical slit sections extending between the intersecting radii on each major face.

16. The valve of claim 15 in which the respective corresponding radii on the opposed major faces define an angle to each other of 10-180 degrees.

17. The valve of claim 16 in which said partition member carries an impregnated lubricating oil.

18. The valve of claim 17 in which said partition is formed of silicone rubber.

19. A medical instrument comprising a housing with means for providing a passage into the body, said housing further including a valve for receiving and sealing an elongated member which penetrates said valve, said valve comprising an elastomeric partition member having a first face and a second, opposed face, said partition member being secured in said housing, said partition member defining a slit extending through said valve between said first and second faces for receiving and sealing the elongated member, at least one of the faces of the partition member defining a concave surface to reduce the central thickness of said partition member with the slit extending through said concave surface, whereby the frictional resistance of the elongated member passing through the slit is reduced.

20. A medical instrument as defined by claim 19, in which both said first face and said second face of the partition member define concave surfaces between which said slit extends.

21. A medical instrument comprising a housing with means for providing a passage into the body, said housing further including a valve for receiving and sealing an elongated member which penetrates said valve, said valve comprising an elastomeric partition member having a first face and a second, opposed face, said partition member being secured in said housing, said partition member defining a slit communicating with said first and second faces for receiving and sealing the elongated member, at least one of the faces of the partition member defining a recessed surface to reduce the central thickness of said partition member with the slit extending through said recessed surface, whereby the frictional resistance of the elongated member passing through the slit is reduced.

22. A medical instrument comprising a housing, said housing including a valve for receiving and sealing an elongated member which penetrates said valve, said valve comprising an elastomeric partition member having a first face and a second opposed face and adapted for securement in a housing, the improvement comprising in combination:
a slit extending through said valve between said first and second faces, said slit defining a first line on said first face and a second line on said second face, said first line and said second line having a similar configuration but being in non-alignment with each other with a generally helical slit section extending between said first line and said second line.

23. The medical instrument of claim 22 in which said first line comprises a first plurality of intersecting radii and said second line comprises a second plurality of intersecting radii, with said first plurality and said second plurality having a similar configuration but being in non-alignment with each other and with generally helical slit sections extending between said first plurality and said second plurality.

24. The medical instrument of claim 22 in which said partition member carries an impregnated lubricating oil.

25. The medical instrument of claim 22 in which said partition member comprises a one-piece unitary member formed of silicone rubber.

26. The medical instrument of claim 22 in which the included non-alignment angle is between 10 and 180 degrees.

27. The medical instrument of claim 22 in which the included non-alignment angle is essentially 60 degrees.

28. The medical instrument of claim 23 in which said first and second plurality each define three intersecting substantially equiangularly spaced radii.

29. The medical instrument of claim 23 in which aid first plurality have an included angle between each radius of between 60 and 180 degrees

30. A catheter sheath introducer including a housing, said housing including an elastomeric partition valve for receiving a catheter which penetrates said valve, said valve having a first major face and a generally parallel and opposing second major faces the improvement comprising, in combination:
slit extending through said partition valve between said first and said second major faces, said slit defining a first plurality of intersecting lines on said first major face and a second plurality of intersecting lines on said second major face, said first plurality and said second plurality having a similar configuration but being in non-alignment with each other with generally helical slit sections extending between said first plurality and said second plurality, said helical slit sections having similar configurations to said first plurality and said second plurality in cross-sectional plane that is generally parallel to and is between said first and said second major faces.

31. A catheter sheath introducer as described in claim 30, in which the line at each major face defines three intersecting substantially equiangularly spaced radii.

32. A catheter sheath introducer as described in claim 31, in which said partition valve comprises a one-piece unitary member carrying an impregnating lubricating oil and being formed of silicone rubber.

33. A catheter sheath introducer comprising a housing, said housing including an elastomeric partition valve for receiving a catheter which penetrates said valve said valve having a first major face and a second generally parallel and opposing second major face, the improvement comprising, in combination:

a generally Y-shaped slit extending through said partition valve between said first and said second major faces, said slit defining a first plurality of intersecting lines of said first major face and a second plurality of intersecting lines on said second major face, said first plurality and said second plurality having a similar configuration but being in non-alignment with each other with generally helical slit sections extending between said first plurality and said second plurality, said helical slit sections having similar configurations to said first plurality and said second plurality in each cross-sectional plane that is generally parallel to and is between said first and said second major faces.

34. A catheter sheath introducer as described in claim 33 in which the included nonalignment angle is 10 to 180 degrees.

35. A catheter sheath introducer as described in claim 33 in which said partition valve carries an impregnated lubricating oil.

36. A method for making an elastomeric partition valve for use in a housing, comprising the steps of:
positioning an elastomeric member having a first face and a second opposed face on a fixture for cutting;

providing a cutting blade;

bringing the cutting blade into alignment with said first face;
providing relative rotation between the cutting blade and the elastomeric member so that the cutting blade progresses from said first face through said second face, with the total rotation having a total angle of rotation of less than 180 degrees, whereby a slit is provided through the partition valve between said first and second faces, and with said slit defining a first line on said first face and a second line on said second face, said first line and said second line having an similar configuration but being in non-alignment with each other.

37. A method for making an elastomeric partition valve for use in a housing of a medical instrument, comprising the steps of:
positioning an elastomeric member having a first face and a second, opposed face on a fixture for cutting;
providing a cutting blade having three equiangularly spaced and radially extending cutting members;
bringing the cutting blade into alignment with said first face;
providing relative rotation between the cutting blade and the elastomeric member so that the cutting blade progresses from said first face to said second face, with the total rotation between said first face and said second face having a total angle of rotation of less than 180 degrees, whereby a slit is provided through the partition valve between said first and second faces, said slit defining a first plurality of intersecting lines on said first face and a second plurality of intersecting lines on said second face, said first plurality and said second plurality having a similar configuration but being in non-alignment with each other.

38. A medical instrument comprising a housing, said housing including a valve for receiving and sealing an elongated member which penetrates said valve, said valve comprising an elastomeric partition member having opposed major faces and secured in a housing, the improvement comprising, in combination:
a slit extending through said partition valve between the major faces thereof, the slit defining a line at each major face, the respective lines at said opposed major faces defining an angle to each other, said slit defining at least one generally helical slit section between said lines on the major faces and within said partition valve.

39. The medical instrument of claim 38 in which the line at each major face defines a plurality of intersecting radii, said radii on one major face being non-aligned with the radii on the other major face and defining an angle to each other between the major faces, the respective, corresponding, opposed radii defining a plurality of said helical slit sections between them, said slit sections being in coaxial relation to each other.

40. The medical instrument of claim 39 in which the line at each major face defines three, intersecting, substantially equiangularly spaced radii.

41. The medical instrument of claim 39 in which said angle is 10 to 180 degrees.

42. The medical instrument of claim 41 in which said angle is 30 to 90 degrees.

43. The medical instrument of claim 39 in which said partition valve carries an impregnated lubricating oil.

44. The medical instrument of claim 43 in which said partition valve is made of silicone rubber.

45. A medical instrument comprising a housing, said housing including a valve for receiving and sealing an elongated member which penetrates said valve, said valve comprising an elastomeric partition valve having opposed major faces and secured in a housing, the improvement comprising, in combination;
a slit extending through said partition valve between the major faces thereof, the slit defining, at each opposed, major face, a plurality of intersecting, substantially equiangularly spaced radii, the respective, individual radii on said opposed face defining an angle of 10 to 180 degrees with each other, the respective, corresponding, angularly related radii on said opposed major faces respectively defining a plurality of helical slit sections between them and within said partition valve, said helical slit sections being in coaxial relation to each other.

46. The medical instrument valve of claim 45 in which the angle of respective radii on said opposed major faces is 30 to 90 degrees.

47. The medical instrument valve of claim 45 in which said partition valve carries an impregnated lubricating oil.

48. The medical instrument valve of claim 45 in which said partition valve is made of silicone rubber.